Ethics

Consumers & Healthcare Should patients have access to their medical records? Paradoxically, access to one's own medical records is the best safeguard to privacy Meredith Carter MJA 1998; 169: 596-597 Introduction - An outdated model? - Impact of information technology - Benefits of subject access - The dilemma of disclosure - Should access to records always be given? - Conclusions - References - Authors' details - - More articles on Law Introduction With the advent of the electronic era, I believe a major deficiency of common law is its failure to provide the person who is the subject of a medical record with a right of access to that record. While legislation gives Australians an enforceable right of access to public sector health records, this is not generally the case for records created by private practitioners or agencies, as highlighted by the 1996 High Court decision in Breen v Williams.1 In this test case, a consumer was denied access to records held by her plastic surgeon, sought for the purpose of legal action against the manufacturer of silicone breast implants. The difference in right to access between the public and private sectors is surprising given the extensive interrelationships between public and private healthcare in this country, and the worldwide efforts to ensure that people have access to files -- including medical records -- kept about them. Australia is now lagging behind most of the developed world in this regard (see Box). Why is addressing this issue so important? Patient access to medical records Australia Only the Australian Capital Territory has legislated to provide individuals with a generic right of access to private sector clinical records.2 New South Wales gives some access under 1996 regulations governing private hospitals, day-procedure centres and nursing homes.3-5 Other developed countries6 The European Union Data Directive (applicable October 1998) requires all 12 member countries to enact legislation enabling subject access to medical records, if not already enacted. The United Kingdom, a member of the European Union, passed the Access to Health Records Act in 1990. The New Zealand Health Information Privacy Code, which came into force in 1993, creates an enforceable right of access. Canadian courts have recognised a common law right of access. Most states in the United States have enacted legislation to ensure subject access to health records, whether created in the public or private sector. An outdated model? Traditionally, consumer interests in health records have been protected through the doctor-patient duty of confidentiality, whereby third-party access to records relied on the doctor's discretion and ability to control flow of the information in the patient's best interests. Now, concerns are increasing that the duty of confidentiality is inadequate for protecting consumer interests. Doctors today interact with a host of other health practitioners, diagnostic services and hospitals, all of whom contribute to the record. An army of support staff also has access. Even the solo private practitioner is no longer an island, but both employs administrative staff and shares relevant patient information with other treating clinicians. Further, many of those who have access to records (eg, receptionists, clerks, administrators and laboratory technicians) have no ethical or other duty to protect consumer confidentiality unless this is built into their contracts. The wider dissemination of data made possible by developments in information technology adds to concerns. Impact of information technology Integration and use of a consumer's personal health information is facilitated by information technology applications such as smart cards, electronic networks between healthcare providers, computerised databases and unique consumer identification systems. Many of these applications involve linking personal information between different health practitioners and providers, and across the public and private sectors. For example, a typical data linkage project might share relevant information between the consumer's general practitioner, pharmacist, hospital, diagnostic and specialist services and perhaps a home nursing service. This enhanced electronic capacity to collate, share, match and manipulate information generates risks as well as benefits. Policies and procedures are needed to ensure that no more than the relevant information is actually disclosed to other treating practitioners, particularly when information is likely to be especially sensitive (eg, psychiatric history and reproductive and sexual matters). Indeed, the Broadband Expert Services Review, commissioned by the Federal Government to consider potential uses of information technology, concluded that current attitudes to consumer access to personal health records were a significant barrier to acceptance of information technology in the healthcare sector.7 This is because of the large array of secondary uses of clinical records over which consumers have little control and which often involve identifiable information. For example, health departments are keen to access health records to determine exactly where health funds are spent and how to target them more effectively. Clinicians want access for peer review and quality assurance, while researchers and public health practitioners can also cite legitimate reasons for access. Outside the healthcare sector, personal health records can influence many aspects of life, such as obtaining employment, life insurance or consumer credit. All too often, consumers are forced to gamble that consenting to disclosure of clinical records to third parties will not damage their interests. Unauthorised access to personal health information by third parties can be very damaging; the Australian Law Reform Commission noted, for example, that commercial clinics doing paternity tests would have a "goldmine" of information about their clients which could cause considerable harm if misused.8 This damage may be even greater if the records were incorrect or misleading. Thus, the clinical record of the future, whether or not correct, will probably be increasingly used to inform highly detailed dossiers about consumers which could affect them significantly. I believe consumer access is crucial in minimising any negative effects. Benefits of subject access As health records become more comprehensive and more widely shared, it becomes correspondingly more important that consumers are comfortable with what goes in the record in the first place, that it is accurate, that they are aware of what information is being distributed and whom it goes to. As absolute security of information in an electronic environment is a myth, the best security consists in ensuring the individual record is accurate. Indeed, without a right of access, some suggest data protection laws are of little use.9 Personal access and a right of challenge and correction are a basic way to promote accuracy.10 Subject access is intrinsic to the concept of individual participation underpinning the Information Privacy Principles in the Privacy Act 1988 (Cwlth). According to Justice Michael Kirby of the High Court, participation is the most notable and important privacy protection safeguard.11 As he has also noted: If you can have access to information about yourself, check it, remove it in some cases and correct it when it is wrong, you have a most powerful weapon to protect your privacy . . . It is privacy used as a sword . . . To protect and assert [one's] own personal interests from the inquisitiveness of government and others alike.8 Organisations such as the Health Issues Centre and the Consumer Health Forum hope that increased access to health records will lead people to participate more in their healthcare decisions. Consumers will have a clearer idea about their condition and treatment and the roles of the various people involved in their care. The evidence available indicates that increased access does have this effect and is likely to have a positive rather than negative impact on doctor-patient relationships.6,12-15 The dilemma of disclosure Access to records is also inextricably linked with effective notice of third party use and informed consent to disclosure. Effective notification and truly informed consent require that individuals know and understand the contents of the record.16Clinicians often hold "confidential" information provided by people other than the subject of the record. Providing a report rather than subject access to the record itself is not a solution to this problem. Information provided by third parties has obvious dangers -- it may be inaccurate and seriously prejudice the consumer's treatment. Most privacy guidelines require confirmation of the accuracy of information on the record before it is acted on,17 and this is particularly important for secondhand information. As subject access becomes more common, health practitioners will need to be circumspect about information from third parties and more open with consumers about what they have been told. Should access to records always be given? The starting point should be a presumption in favour of disclosure to the individual concerned, but this is not to argue that access to records should always be given, especially when it is likely to cause serious harm, either to the consumer or to a third party. However, withholding the record should be considered unusual and subject to review to ensure the practitioner's concerns are substantiated (eg, by an alternative clinician nominated by the consumer). As Bloch and colleagues have noted, studies focusing on patients' reactions to their records have shown therapeutic benefits, even when they did not like what they learned.12 While some patients may need support when accessing clinical files, these findings apply generally, even in psychiatric cases.12 It also seems likely that, as consumer access becomes the norm, a more participatory approach to creation of the record will result. So, access is not just about privacy, but also about facilitating communication, informed consent to treatment and quality of healthcare. Conclusions Traditional approaches to protecting personal health information focus on the doctor's discretion and security of the record. Today, in an electronic environment with a team approach to health care, this approach is inadequate and undermines the trust fundamental to the doctor-patient relationship. Consumer access to their records will help reinforce that trust. We must move from a focus on security to a focus on participation. References Breen v Williams (1996) 186 CLR 71. Health Records (Privacy and Access) Act 1997 (ACT). Private Hospitals Regulation 1996 (NSW). Day Procedures Centres Regulation 1996 (NSW). Nursing Homes Regulation 1996 (NSW). Cornwall A. Consumer access to health records. Health Law Bull 1996; 5: 81-90. Anthony D, Mandeville T, Hearn G, Holman L. Demand for Broadband services in the health sector. Brisbane: Communication Centre, Queensland Institute of Technology, 1994: 46-47. Australian Law Reform Commission. Freedom of information discussion paper 59. 1995: para 11.21, footnote 58. Gellman R. Approaches to privacy protection in the United States: genetic privacy. Proceedings of the 14th International Data Protection and Privacy Commissioners Conference. 1992: 69, 74. Crowe B. Telemedicine in Australia. Australian Institute of Health and Welfare Discussion Paper. Canberra: AIHW, 1993: 9. Kirby M. Reform the law: essays on the renewal of the Australian legal system. Canberra; AGPS, 1983: 201-202. Bloch S, Riddell C, Sleep T. Can patients safely read their psychiatric records? Med J Aust 1994; 161: 665. Bergen L. Patient access to medical records: a review of the literature. Aust Med Rec J 1988; 18: 102. Parrott J, Strathdee G, Brown P, et al. Patient access to psychiatric records: the patient's view. J R Soc Med 1988; 8: 520. Westbrook J. Patient access to medical information, Part 1: a review of the issues. Aust Med Rec J 1988; 18: 11. O'Connor K. Confidentiality, privacy and security concerns in the modern health care environment. Aust Computer J 1994; 26: 70. Privacy Act 1988 (Cwlth). Information Privacy Principle 2. Authors' details Health Issues Centre, Melbourne, VIC. Meredith Carter, LLB, BA, Director. Reprints will not be available from the author. Correspondence: Ms Meredith Carter, Health Issues Centre, Level 11, 300 Flinders Street, Melbourne, VIC 3000. E-mail: hicjmcATvicnet.net.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Meredith Carter

Should research ethics change at the border? The use of placebos in HIV drug trials has raised concerns about research ethics in developing countries MJA 1998; 169: 509-510 Research on mothers with HIV in poor countries has attracted vehement criticism. The researchers (largely funded from the West) are accused of changing their ethics "at the customs desk."1 In defence of their own position researchers (and their sponsoring bodies) claim that ethical standards are unrealistic and that local conditions require studies "that might not be found ethically acceptable in developed countries."2 They argue for achievable standards that depend on local circumstances.2-4 The controversy concerns the use of placebos in zidovudine drug trials on mothers with HIV in Thailand, Africa and the Caribbean. The trials aimed to test the effectiveness of a short course of low-dose zidovudine in preventing transmission of HIV from mothers to infants by comparing transmission rates of mothers given zidovudine with those offered only a placebo. The short course is an alternative to a more expensive regimen of treatment with zidovudine for both mother and infant previously demonstrated to be effective in the trial known as ACTG 076.5 Although the ACTG 076 regimen has been effective in reducing transmission rates by almost 70%, it is not available in resource-poor countries because of the cost and lack of necessary facilities and support.3 Placebo trials in Thailand have recently shown that a simplified regimen of zidovudine was effective in reducing the transmission of HIV between infected mothers and their infants by 51%. This finding is from studies with women who did not breastfeed and who were given zidovudine orally for three to four weeks before birth. No zidovudine was given to their infants.6 This result now makes it clear that placebo comparisons are no longer ethical in mother-to-child HIV transmission studies, even in poorer countries. However, it does not answer the charge that they were unethical in the first place. It is an issue that is still current because there are other diseases for which treatments are available in the West, but not in resource-poor countries. Could placebo trials be justified to test cheaper alternative treatments for these diseases? Furthermore, to continue the logic of the Thai HIV transmission trials, is it ethical to test an even cheaper (shorter course and lower dose) zidovudine regimen? In broad terms the issue is whether ethical standards in research apply across borders, irrespective of poverty and lack of supporting health care systems. The concern with "ethical relativism" in HIV research1,7 is an instance of a long-standing debate between universalism and relativity in ethics, with the universalists arguing for an "irreducible set of ethical standards" that apply internationally.8 These include requirements that the interests of participants in research be given priority over potential benefits for science and society;9 that there be "genuine doubt" as to whether an alternative is as good as standard accepted treatment;10 that studies be approved by an independent committee;9 and that no study be conducted in a foreign country unless it meets the standards of the sponsoring country.11 Failure to accept these minimal conditions, it is argued, is an invitation to unscrupulous researchers and companies to exploit poorer countries.11 Lurie and Wolfe ask ". . . why not select the approach that minimizes loss of life?"11 Although these authors opposed the placebo studies, the answer to their question may well support the placebo trials in Thailand, in that they were quicker and their results support immediate implementation of an effective treatment program (albeit one not as effective as the ACTG 076 regimen). The indications are that in the long run these particular placebo trials will save more lives. Does this end result justify research that withheld effective treatment from HIV-infected mothers and their infants? I admit to being caught between the arguments: on the one hand it is abhorrent to accept that mothers were recruited for studies in which some of them were deprived of a treatment that might have protected their child from contracting HIV. On the other hand, a great many more (future) lives may have been saved. The pragmatic argument is that we must do what we can to test and find effective treatments which can be made available in conditions of poverty. The inequity lies, not in researchers withholding effective treatment, but in a callous world that tolerates gross disparities between rich and poor countries. Researchers are trying to reduce (where they can) some of those inequities. Could there be a middle way between the extremes of universalism and relativity? Nussbaum, while supporting a universalist approach to ethics, argued for "a delicate balancing between general rules and a keen awareness of particulars, in which process . . . the particular takes priority . . . in the sense that a good rule is a good summary of wise particular choices, and not a court of last resort."12 From this perspective, the rule that research must meet the standards of the sponsoring country may need "modification in the light of new circumstances".12 If we take this lead, there may be no simple answer. Each situation would require a careful analysis, guided by internationally accepted rules, and applied with a keen sense for the most humane decision in those circumstances. Certainly, we should be on our guard and block research which simply exploits those in poverty. However, the "wise choice"12 that most benefits people in poor countries may not always conform to Western standards. In this issue of the MJA Studdert and Brennan13 call for "dialogue about whether a universal standard of care is applicable." Although this debate may no longer be relevant to studies of mother-to-child HIV transmission, it remains an important ethical question in responding to dire health needs of those in poor countries. Paul M McNeill Associate Professor in Ethics and Law Faculty of Medicine, University of New South Wales Sydney, NSW Acknowledgement: My thanks to Gregory J Dore, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, for information on recent developments and his many helpful comments. Cohen J. Ethics of AZT studies in poorer countries attacked. Science 1997; 276: 1022. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997; 337: 1003-1005. Levine RJ. The "best proven therapeutic method" standard in clinical trials in technologically developing countries. IRB -- A Review of Human Subjects Research 1998; 20(1): 5-9. Merson MH. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the third world [letter]. N Engl J Med 1998; 338: 836. Centers for Disease Control and Prevention. Administration of zidovudine during late pregnancy and delivery to prevent perinatal HIV transmission -- Thailand, 1996-1998. JAMA 1998; 279: 1061-1062; also in MMWR - Morbid Mortal Wkly Rep 1998; 47(8):151-154. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med 1994; 331: 1173-1180. Angell M. The ethics of clinical research in the third world. N Engl J Med 1997; 337: 847-849. Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med 1988; 319: 1081-1083. McNeill PM. The ethics and politics of human experimentation. Sydney and London: Cambridge University Press, 1993: 165-183. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141-145. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997; 337: 853-856. Nussbaum N. Non-relative virtues: an Aristotelian approach. In: Nussbaum N, Sen A, editors. The quality of life, Oxford University Press, 1993: 242-269, at 257. Studdert DM, Brennan TA. Clinical trials in developing countries: scientific and ethical issues. Med J Aust 1998; 169: 545-547. - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Paul M McNeill

Clinical trials in developing countries: scientific and ethical issues David M Studdert and Troyen A Brennan Since the 1994 finding that intensive zidovudine treatment of mothers and infants can dramatically reduce perinatal transmission of human immunodeficiency virus, this treatment has been widely adopted in developed countries. In developing countries, trials of less-intensive (and cheaper) regimens have gone ahead, many funded by foreign governments and the United Nations. Controversy has erupted over these trials, particularly over their use of placebo controls. Do differences in healthcare needs and budgets justify different ethical standards in the developed and the developing world? MJA 1998; 169: 545-548 For editorial comment, see McNeill Introduction - The arguments - Ethical principles in international human research - Efficacy and use of placebo - Standard of care: is it relative? - References - Authors' details - - More articles on Ethics - ©MJA1998 Introduction Controversy over AIDS clinical trials in developing countries has galvanised public attention and divided the medical research community.1-4 The trials in question, in sub-Saharan Africa and Thailand, use randomised, placebo-controlled methods to test the effectiveness of interventions in preventing perinatal transmission of human immunodeficiency virus (HIV).5,6 At least nine of these trials have received US government funding through the Centers for Disease Control (CDC) or National Institutes of Health (NIH), while five are funded by other foreign governments, and one by the United Nations Program on AIDS (UNAIDS). Background to the controversy is shown in the Box. Debate was sparked in September 1997 by an article5 and an editorial13 in the New England Journal of Medicine. The editorial likened the trials to the notorious Tuskegee study of untreated syphilis (1938-1972),14 a US government study that continued to follow the natural progression of syphilis in a cohort of poor African American males long after penicillin became widely available. This comparison prompted two prominent members of the journal's editorial board to resign,15 and drew a rebuttal from the CDC and NIH.8 In October 1997, investigators discontinued use of placebos in an NIH-funded study of two short-course zidovudine regimens in Ethiopia.16 Then, in February 1998, the CDC and the Thai government announced that their placebo-controlled study of a short-course zidovudine regimen in Thailand had shown a 51% reduction in perinatal HIV transmission rates.17 At the same time, they announced that further use of placebos would cease in both this study and another in Cote d'Ivoire.11 The CDC, NIH, UNAIDS, and France's National Agency for AIDS Research (ANRS) have called for international dialogue on the "far-reaching scientific and policy implications of these findings".12 Nonetheless, a range of other foreign-sponsored clinical trials continue in developing countries, as does the debate about their ethics. To date, this debate appears to have generated more heat than light: the lines of arguments are often unclear, and it is difficult to isolate the central points of disagreement. For example, both critics and defenders of the trials claimed that the Thai findings vindicated their respective positions.18 In this article, we outline the main arguments and propose a framework for analysing some of the scientific and ethical issues. The arguments The critics' main objection to the trials is that investigators withhold an effective therapy from women and children who are randomised into control arms. Deprivation of a therapy known to be effective, albeit in an intensive and expensive form, has been construed as "ethical relativism".13,19 It is argued that this violates the principle that protections given to human subjects abroad should be "no less exacting" than those given in sponsoring countries.20 Two similar studies under way in the US gave all participants access to zidovudine and other antiretroviral drugs.5Arguments from defenders of the trials are interrelated, but may be divided roughly into three categories: First, it is argued that significant differences in resources and health conditions between countries can alter the balance that must be struck between risks (to study participants) and benefits (to study participants and others).8,21,22 In other words, a study may be acceptable in one country but not another because of differences in wealth or burdens of disease between the two. Second, the technical superiority of placebo-controlled methods is argued to have ethical implications.8,23 Faster answers are said to be possible with enrolment of fewer subjects. Defenders also attach moral weight to the fact that absolute, rather than marginal, benefits may be measured. At stake in this distinction, it is argued, is the difference between results that lead to life-saving policies, and results that simply raise new questions. Finally, defenders attach importance to satisfaction of process requirements.8,24,25 For example, they highlight the support and participation of host country governments and the approval of ethics review committees in the host and sponsoring countries. Study subjects' consent to participate is also highlighted, although critics have questioned whether this consent is truly "informed".26 More ardent defenders combine strands of difference and process arguments and caution against an "imperialism"27 that would second-guess the willing participation of individuals in the developing world. Ethical principles in international human research A decade ago, Marcia Angell (now Executive Editor of the New England Journal of Medicine) asked whether ethical standards should be "substantially the same everywhere, or is it inevitable that they differ from region to region, reflecting local beliefs and custom?"28 Today it is widely accepted that all research subjects are entitled to minimum guarantees that are transnational and non-negotiable.29 Realisation of these entitlements is, of course, a separate matter. However, institutional mechanisms for promulgating and applying human subject protections have advanced considerably, hurried on by several scandals and major public inquiries.30,31 Many countries, including Australia, New Zealand, and the United States, use formal ethics review committees and similar criteria to evaluate any government-funded study involving human subjects, wherever and however it is conducted. Among the minimum guarantees, formalised in the World Health Organization's Declaration of Helsinki32 and reiterated in guidelines promulgated by governments and institutions, are: The study must have a valid scientific design and be performed by qualified persons. It must strike a reasonable balance between the predictable risks and foreseeable benefits to the subjects or others, with the proviso that the subjects' interests should never be subordinate to those of science and society. All study subjects must consent to participate, a decision that must be made without duress or coercion and only after details of the study are provided. When investigators from one country conduct research in another country, it is appropriate to add to this list of minimum guarantees the requirement that: The research must hold the promise of direct, tangible, and significant benefit to the host country population, if not to the study subjects themselves.8 However, determining whether such benefits are likely to accrue can be problematic, because researchers and government officials in the host country will often have a vested interest in ensuring that the research proceeds. Efficacy and use of placebo Satisfaction of the above process requirements is a necessary, but not sufficient, basis for ethical research. A second inquiry is needed before accepting placebo-controlled studies: does the drug or intervention proposed for randomisation have proven therapeutic efficacy? If so, then a placebo-controlled study design is ethically suspect.33 Investigators will not be in the state of "equipoise", or indeterminacy, necessary to avoid conscious provision of inferior treatment to study subjects.34The zidovudine trials might be said to present the "easy case" for such analysis. Findings from the ACTG 076 protocol in 1994 were compelling, and the recent Thai results must now deepen concern about continued use of placebos in any zidovudine study, whether in Thailand or elsewhere. However, there are important subtleties. Firstly, efficacy may or may not be generalisable across countries with wide disparities in baseline levels of health status, healthcare services, and burdens of disease.8,25,35 Whether this problem raises serious doubts about the efficacy of the ACTG 076 regimen in sub-Saharan Africa is debatable, especially after the Thai results. However, it does illustrate a more general point -- failure to separate the question of efficacy, at least initially, from considerations about whether a universal standard of care is applicable may obscure important scientific questions. Another complication is that judgements about efficacy can be problematic when the scientific evidence is equivocal. For example, several years ago our own human subjects committee at the Harvard School of Public Health considered a protocol for a placebo-controlled study of the effect of vitamin A and multivitamins on perinatal HIV transmission in Tanzania. The decision to approve the study was difficult because data on the prophylactic benefits of micronutrient supplementation for HIV-infected women were inconclusive, and remain so today. (However, recently published findings show other pregnancy-outcome benefits36 which would enter the ethical calculation were a similar protocol reviewed today.) How is equivocal evidence on efficacy to be weighed? Although the efficacy question has ethical implications, we believe it is a technical or scientific question at the outset. Hence, it may be useful for the ethics review committee to require investigators to summarise the evidence for efficacy of an intervention. If efficacy is established anywhere, the investigators should satisfy a threshold level of doubt about its applicability to their study site. However, this task subjects the investigators to competing pressures, requiring them to demonstrate to ethics committees and sponsors that their hypothesis is valid and that the intervention has some reasonable expectation of an effect, while simultaneously marshalling evidence for doubt. To guard against this conflict, ethics review committees may wish to convene independent scientific panels to evaluate evidence on efficacy. When efficacy is established or is in the "grey area", committees might also require investigators to report on potential alternative approaches -- such as "equivalence"37 or "observational"38 study designs. In summary, given that fundamental requirements of human subjects research are met, poor evidence about efficacy should allay many ethical concerns. On the other hand, when the proposed intervention has known efficacy -- or there is a sound basis for inferring efficacy -- and no alternative study approach is feasible, a further question arises: is it ethically acceptable to confine subjects in the control arm to treatments which are considered substandard in the sponsoring country? Standard of care: is it relative? The current debate is devoting much energy to the question of whether different conditions abroad can justify lower standards of care, especially when the differences arise from resource inequities. This question is certainly raised by some of the AIDS trials under scrutiny, as the ACTG 076 regimen has become a standard treatment for seropositive pregnant women in the United States and many other developed countries.39 However, the larger question is whether non-conformity with sponsoring-country standards is a sufficient basis for stopping any placebo-controlled study abroad, or whether clear-cut answers to the efficacy question in this particular case merely help to explain why the trials are objectionable. Lurie and Wolfe note, "as a model of an ethically conducted study",5 a comparison in Thailand of three short zidovudine regimens with a regimen similar to the ACTG 076 regimen. A placebo-controlled design was considered and rejected by our human subjects committee at the Harvard School of Public Health.5 Although the recent Thai findings17 were not at hand, the committee and investigators agreed that an equivalence design could achieve the study's main goals. In addition, the committee was mindful of anecdotal evidence that a regimen similar to ACTG 076 was soon to be widely available in Thailand. One interpretation of the committee's decision is that it underscores a commitment to an inviolable standard of care. However, a better account of deliberations is that the standard-of-care question was not directly considered, because an alternative study approach was feasible, and there was genuine doubt about whether the placebo treatment even met the host country's standard of care. Had neither of these factors been present, then the standard-of-care question would have been under consideration as the primary basis for approving or rejecting the study protocol. We hesitate to predict the outcome. A careful, global dialogue is needed on how international medical research involving human subjects should deal with inevitable differences in standards of care. Rigid adherence to a universal standard of care will narrow, perhaps even eliminate, the opportunities for placebo-controlled studies in the developing world. It is not clear that the research community, or the majority of citizens in any country, are ready to embrace this consequence, particularly as the gap in resources and disease burden between developed nations and sub-Saharan Africa continues to widen.40 References Annas GJ, Grodin MA. An apology is not enough. Boston Sunday Globe 1997 May 18; Sect C: 1. Stolberg SG. U. S. AIDS research abroad sets off outcry over ethics. New York Times 1997 Sep 18; Sect A: 1. AIDS in Africa. The Economist 1997; Sep 27: 19. Stolberg SG. Job itself in doubt as new feud looms on surgeon general. New York Times 1998 February 5; Sect A: 1. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997; 337: 853-855. Phanuphak P. Ethical issues in studies in Thailand of vertical transmission of HIV. N Engl J Med 1998; 338: 834-835. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med 1994; 331: 1173-1180. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997; 337: 1003-1005. Waldholz M. AZT price cut for third world mothers-to-be. Wall Street Journal 1998 Mar 5: Sect B: 1. Frenkel LM, Cowles MK, Shapiro DE, et al. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis 1997; 175: 971-974. Centers for Disease Control. Update on CDC Collaborative research studies on perinatal HIV prevention in the developing world: preliminary results find short-course AZT effective. 1998 Feb:<http://www.cdc.gov/nchstp/od/Perinatal> Centers for Disease Control and Prevention (CDC), The Joint United Nations Programme on HIV/AIDS (UNAIDS), The National Institutes of Health (NIH), and The Agence Nationale de Recherche sur le SIDA (ANRS). Joint statement. 1998 Feb 18:<http://www.unaids.org/highband/press/cdcjs8> Angell M. The ethics of clinical research in the third world. N Engl J Med 1997; 337: 847-849. Jones JH. Bad blood: the Tuskegee syphilis experiment. New York: Free Press, 1993. Altman LK. AIDS experts leave journal after studies are criticized. New York Times 1997 October 15; Sect A: 1. Another HIV-1 trial loses placebo control. Lancet 1997; 350: 831. Centers for Disease Control. Short-course regimen of AZT proven effective in reducing perinatal HIV transmission: offers hope for reducing mother-to-child HIV transmission in developing world. 1998 Feb 24. <http://www.cdc.gov/od/oc/media/ pressrel/r980224.html> US ends placebo use in foreign AIDS study. Chicago Tribune 1998 Feb 19: Sect N: 14. Angell M. Tuskegee revisited. Wall Street Journal 1997 Oct 28; Sect A: 22. World Health Organization. International ethical guidelines for biomedical research involving human subjects. Geneva: Council for International Organizations of Medical Sciences, 1993. Bagenda D, Muske-Mudido P. A look at ... ethics and AIDS. Washington Post 1997 Sep 28; Sect C: 3. Saba J, Ammann A. A cultural divide on AIDS research. New York Times 1997 Sep 20; Sect A: 15. Simonds RJ, Rogers MF, Dondero TJ. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the third world [letter]. N Engl J Med 1998; 338: 836-837. Study volunteers support placebo-controlled AIDS trials; AZT to prevent vertical transmission of HIV in South Africa. AIDS Weekly Plus 1997 Oct 27: 24. Mbidde EK. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the third world [letter]. N Engl J Med 1998; 338: 837. French HW. AIDS research in Africa: juggling risks and hopes. New York Times 1997 Oct 9: Sect A: 1. Cohen J. Ethics of AZT studies in poorer countries attacked. Science 1997; 276: 1022. Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med 1988; 319: 1081-1083. Penslar RL. Research ethics: cases and materials. Bloomington: Indiana University Press, 1995. Report of the Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at the National Women's Hospital and into Other Related Matters. Report. Auckland: Government Printing Office, 1988. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont report: ethical principles for the protection of human subjects research. Washington, DC: Government Printing Office, 1988. World Medical Association, Declaration of Helsinki IV. Adopted by the 18th World Medical Assembly, Helsinki 1964, as amended by the 41st World Medical Assembly, Hong Kong, 1989. <http://www.nih.gov/grants/oprr/irb_appendices.html#j6> Chalmers TC. The clinical trial. Milbank Mem Fund Q 1981; 59: 324-339. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141-145. Merson MH. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the third world [letter]. N Engl J Med 1998; 338: 836. Fawzi WW, Msamanga GI, Spiegelman D, et al. Randomized trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-infected women in Tanzania. Lancet 1998; 351: 1477-1482. Ware JH, Antman EM. Equivalence trials. N Engl J Med 1997; 337: 1159-1161. Blanche S. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the third world [letter]. N Engl J Med 1998; 338: 837-838. Recommendations of the US Public Health Service Task Force on the use of zidovudine to reduce perinatal transmission of human immunodeficiency virus. MMWR Morb Mortal Wkly Rep 1994; 43 (RR-11): 1-20. United Nations Development Program. Human Development Report. New York: Oxford University Press, 1997. Authors' details Department of Health Policy and Management, Harvard School of Public Health, Boston, MA, USA. David M Studdert, LLB, ScD, MPH, Instructor; and Fellow in Medical Ethics, Harvard Medical School, Boston, MA; currently, Social Scientist, RAND Corporation, Santa Monica, CA, USA. Troyen A Brennan, MD, JD, MPH, Professor of Law and Public Health; and Professor of Medicine, Harvard Medical School, Boston, MA. Reprints: Dr D M Studdert, RAND Corporation, 1700 Main Street, Santa Monica, CA 90407-2138 USA. E-mail: studdertATrand.org - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

David M Studdert · Troyen A Brennan

Legal implications of clinical practice guidelines Clinical practice guidelines may be used as evidence, but this should not distract doctors from their advantages. MJA 1998; 169: 292-293 Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.1 Formulated by the United States Institute of Medicine, this definition was used by the National Health and Medical Research Council (NHMRC) in its work on clinical practice guidelines. In 1995, the NHMRC published guidelines for the development and implementation of clinical practice guidelines.2 It described a worldwide focus on guidelines ". . . prompted by concern about unjustifiable variations in clinical practice for the same condition, the increased availability of new treatments and technology and uncertainty as to the effectiveness of many interventions in improving people's health and a desire to make the best use of available health resources".2 The NHMRC emphasised the need for clinical practice guidelines to be based on the best available evidence. Relevant to this need are principles of evidence-based medicine, which entail the explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.3 Since 1995, the NHMRC has published nine clinical practice guidelines: on early breast cancer, coronary heart disease, depression in young people, prevention of stroke, uncomplicated lower urinary tract symptoms in men, unstable angina, preterm birth, diabetic retinopathy, and acute pain management.4 Clinical practice guidelines are not intended to replace clinical judgement, nor can they. They are not prescriptive, but serve to guide practitioners in making relevant clinical interventions. Used correctly, they can assist more informed and meaningful patient participation in treatment decisions. They can enhance and maintain professional standards and quality assurance programs. By reducing unnecessary variations in practice they may encourage cost-effective healthcare. Despite these potential benefits, some doctors are uncertain about the legal implications of clinical practice guidelines. One study found that Australian general practitioners did not regard legal implications as very important to their decision to follow guidelines.5 In another survey, 32% of clinicians were unsure whether guidelines on managing early breast cancer would be used to sue doctors and 45% agreed or strongly agreed that they would.6 In a survey of surgeons' opinions about the NHMRC clinical practice guidelines for the management of early breast cancer (published in this issue of the Journal), 41% of surgeons felt that guidelines would protect clinicians from legal implications, whereas 37% believed clinicians would be exposed to increased medicolegal problems by using them.7 The risk of legal liability is not unimportant, but for medical practitioners to approach clinical practice guidelines from a defensive perspective may well deny them and their patients the opportunity to achieve optimal health outcomes, an objective of paramount importance to the medical profession. The law imposes on a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice and treatment. This duty is a single, comprehensive one covering all the ways in which a doctor is called upon to exercise his or her skill and judgement. It extends to the examination, diagnosis and treatment of a patient, the provision of information and the processes of obtaining the patient's consent to treatment.8 The word reasonable is important. As a former Chief Justice of the High Court of Australia observed: "It is easy to overlook the all-important emphasis placed upon the word 'reasonable' in the statement of the duty. Perfection or the use of increased knowledge or experience embraced in hindsight after the event should form no part of the components of what is reasonable in all the circumstances."9 The standard of reasonable care and skill required is that of the ordinary skilled practitioner exercising and professing to have the capabilities required in the particular field of medical practice under consideration.8 In ascertaining what, in a particular case, constitutes reasonable care and ordinary skill in the relevant medical discipline, a court will usually receive evidence of the practice of medical practitioners and the state of medical knowledge at the relevant time. This evidence is usually given as expert opinion from medical witnesses and is of considerable significance when there are allegations of negligence in diagnosis or treatment. However, evidence of professional practice cannot dictate to a court the standard of care applicable to the clinical facts before it. The court will determine the standard demanded by the law in the practice of medicine (or, indeed, in the practice of any other profession). Clinical practice guidelines might be introduced into evidence before a court either by a plaintiff or by a defendant doctor. If so, it is likely that they would be included within the evidence of an expert medical witness given in the usual way. Soundly based clinical practice guidelines may well serve to make medical expert opinion more reliable and acceptable to a court,10 but are unlikely to alter the usual evidentiary processes in litigation. In considering the probative value of any clinical practice guidelines in evidence before it, a court would need to be satisfied, by appropriate evidence of their manner of formulation, of the quality and reliability of the medical/scientific evidence upon which they are based as well as their currency, acceptance and use by the profession. In an appropriate case, a medical witness called to give expert opinion evidence on behalf of a plaintiff might refer to clinical practice guidelines, offering the opinion that the defendant doctor had wrongly departed from the guidelines in the treatment of the patient. It would be open to a defendant doctor to counter this with evidence that the guidelines were not available at the time, outdated or not relevantly endorsed, or that clinical factors justified departure from the guidelines in the exercise of professional judgement, or that the treatment given did in fact comply with the guidelines. Given their purpose and evidence-based foundation, it is unlikely that clinical practice guidelines will promote litigation. Arguably, they may well reduce it by reducing any uncertainty about what constitutes reasonable medical practice. The legal implications of clinical practice guidelines were considered recently at a forum convened by the New South Wales Department of Health, together with the NHMRC National Breast Cancer Centre and United Medical Protection Ltd. A summary of the recommendations arising from the forum and the basis for their formulation are reported in this issue of the Journal.11 When properly understood, clinical practice guidelines will be appreciated for the significant beneficial purposes for which they are designed. In considering acceptance and use of clinical practice guidelines, the medical profession should not be distracted by speculation about legal implications. Nevertheless, as it appears that patients have become more litigious and doctors more vulnerable to allegations that they have failed their patients,12 clinical practice guidelines may become an important part of clinical risk management. Ultimately, care may well come to be regarded as less than reasonable should clinical practice guidelines be available but not followed, unless this can be justified on appropriate clinical grounds. Peter Dwyer Barrister 11th Floor, St James Hall 169 Phillip Street, Sydney, NSW Field MJ, Lohr KN. Clinical practice guidelines: directions for a new program. Washington, DC: Institute of Medicine. National Academy Press, 1990. National Health and Medical Research Council. Guidelines for the development and implementation of clinical practice guidelines. Canberra: NHMRC, 1995. Sackett DL, Richardson WS, Rosenberg WR, Haynes RB. Evidence-based medicine: how to practice and teach EBM. New York: Churchill Livingstone, 1997: 2. Smallwood RA, Lapsley HM. Clinical practice guidelines: to what end? Med J Aust 1997; 166: 592-595. Gupta L, Ward J, Hayward RSA. Clinical practice guidelines in general practice: a national survey of recall, attitudes and impact. Med J Aust 1997; 166: 69-72. Ward JE, Boyages J, Gupta L. Local impact of the NHMRC early breast cancer guidelines: where to from here? Med J Aust 1997; 167: 362-365. Carrick S, Benevista B, Redman S, et al. Surgeons' opinions about the NHMRC clinical practice guidelines for the management of early breast cancer. Med J Aust 1998; 169: 300-305. Rogers v Whitaker (High Court of Australia) 175 CLR 479. Per Barwick CJ in Maloney v Commissioner for Railways (NSW) [1978] 52 ALJR 292 at 292. Tjiong RTT. Reforming the law on expert evidence. Med J Aust 1998; 168: 53-54. Pelly JE, Newby L, Tito F, et al. Clinical practice guidelines before the law: sword or shield? Med J Aust 1998; 169: 330-333. Tomkins C. Recent trends in litigation worldwide -- the implications for Australia. J Med Defence Union July 1998: 2-4. - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Peter Dwyer

Clinical practice guidelines before the law: sword or shield? Janet E Pelly, Liza Newby, Fiona Tito, Sally Redman and Amanda M Adrian Clinical practice guidelines are designed to improve patient care by promoting best practice. But what is the status of clinical practice guidelines in law? MJA 1998; 169: 330-333 For editorial comment, see Dwyer Subsequently cited in Maddern, Surgery and evidence-based medicine, MJA 1998; 169: 348-349. Introduction - Questions and answers - Where to next? - Acknowledgements - References - Authors' details - - ©MJA1998 Introduction The purpose of clinical practice guidelines (CPGs) is to achieve better health outcomes by improving the practice of health professionals and by better informing consumers about management options.1There is good evidence that CPGs can improve patient management. A review of 59 studies2 which evaluated the effect of CPGs on clinical care detected significant improvement in the process of care in all but four of the studies. Nine of 11 trials that assessed the outcome of care reported significant improvements.2 Despite the widespread recognition of CPGs' potential value in improving care, their legal status has been unclear and of growing concern to some health professionals. For example, the National Health and Medical Research Council National Breast Cancer Centre (NBCC) surveyed a representative sample of 150 surgeons to determine their views on the NHMRC Clinical Practice Guidelines for the Management of Early Breast Cancer;3 37% felt that the guidelines would increase their exposure to medicolegal problems, while 41% felt that CPGs would protect clinicians from legal problems.4 It is perhaps not surprising that there is a lack of clarity about how CPGs may be used in a legal arena. In particular, there is confusion about whether doctors will be more, or less, vulnerable to a successful lawsuit if they follow guidelines or depart from guidelines for sound clinical reasons. Will the guidelines be a shield, enabling doctors to show that they were not negligent because they followed the CPGs? Or will they be a sword, enabling a plaintiff's lawyers to establish negligence in court when they show that the doctor's treatment of the patient departed from the CPGs? How will the courts deal with the fact that proper clinical management of individual patients cannot always be achieved by strict adherence to guidelines? Because of the time lag before malpractice cases come to court, litigation currently before court often relates to incidents which occurred several years before CPG use became widespread. To date, CPGs have rarely, if ever, been used as evidence in medical litigation, and there is virtually no judicial comment on their legal status. There is little information available, even from the United States. In one of the few studies that looked at how guidelines are used in the US legal system,5 259 randomly selected insurance company malpractice claims were reviewed and 960 medical malpractice attorneys were surveyed. Clinical guidelines were important or used as evidence in only 6% of surveyed cases and, significantly, were used by both plaintiff and defendant. However, this study related to claims which were opened in 1990-1991, a period when rigorously developed, evidence-based guidelines were not common.5 Interestingly, CPGs did appear to play a role in the decision to settle; 27% of attorneys reported that the existence of guidelines in respect of a particular disease or condition had influenced their decision to settle, and 26% of plaintiffs' attorneys reported that guidelines were influential at least once in the previous year in a decision not to take a case.5 Against this background, and because of concerns by some clinicians about the adoption of the NHMRC's early breast cancer guidelines, the NBCC commissioned a research paper in June 1997 on the medicolegal implications of CPGs. A forum was then convened to address several issues relating to the law and CPGs (Box 1). Where do guidelines fit in the legal process? The commissioned research paper6 explored the Australian and international experience and concluded that: Clinical practice guidelines neither hinder nor encourage litigation directly -- they are simply likely to be considered another form of expert evidence; or evidence of practice in a court case. In considering CPGs as "just another form of expert evidence", the authors of the paper noted that the evidentiary value of guidelines depends on their purpose, development, ratification, dissemination, use, and whether they are current. For example, in the United Kingdom, judges do not automatically equate established guidelines with reasonable and proper medical practice. Questioning (in court) may address the scope of the guideline, how it was developed and adopted, the mandatory force of its recommendations, the existence of known exceptions to its application, and whether any school of medical thought rejects it and adopts a different approach to treatment.7 The same rules would apply in Australia and the United States. In Australia, the NHMRC has established a nationally credible and effective process for the development, ratification and endorsement of CPGs, and in October 1995 published Guidelines for the development and implementation of clinical practice guidelines,1 which is currently being updated. Endorsement by a recognised expert body such as the NHMRC may add weight to the evidentiary value of guidelines, as can formal evaluations which establish the clinical efficacy of the guideline. Where CPGs are accepted as good evidence of appropriate practice, it can be more difficult for a doctor whose actions and decisions are not consistent with the CPG's recommendation to defend a case simply on the basis of customary local practice.6 Recommendation of the forum: see points 1, 2, and 3 (Box 2). How will guidelines be considered as evidence? Some clinicians are concerned that courts will treat CPGs as inflexible rules of conduct, and thus reduce the scope for individual clinical judgement in particular cases. However, the result of any litigation will depend on the evidence brought before a court. The patient who is suing a doctor must prove negligence on the part of the doctor. Where a clinician has not followed a CPG, there is no automatic assumption of negligence. A clinician could show that the guideline was not relevant in a particular case. Alternatively, he or she could show that the treatment actually provided was supported by other good evidence, or that the guideline was sufficiently flexible to include the chosen treatment. Equally, following a guideline may not automatically prevent a doctor from being sued successfully for negligence. It will depend on all the evidence before the court. The authors of the research paper argue that, were CPGs not available, similar information could be adduced from the scientific information used to develop guidelines. However, there is little doubt that the meta-analysis and distillation of this often enormous volume of scientific evidence, as achieved in a rigorous guideline development process, make the research and clinical practice more understandable to a court, just as it does to an individual consumer or clinician. Therefore, guidelines can aid the legal process by presenting a clear summary of available evidence, rather than leaving the courts with the responsibility of distilling this information from expert testimony. Recommendation of the forum: see point 4 (Box 2). Will a doctor be medicolegally protected if he or she practises within the guidelines? CPGs are not designed to be prescriptive rules, but, rather, to provide guidance. They provide leeway for clinical judgement concerning the circumstances of the patient, the preferences of the patient and a range of other factors. This flexibility is explicitly stated in the introduction to the NHMRC's early breast cancer guidelines. Following them to the letter would not be possible or desirable; as such, words like "must" or "should" are not appropriate, and are not used in these guidelines. With appropriate ratification and credible standing in the health community, guidelines may well represent the agreed professional "standard of care", but the courts are the final arbiters of this standard, and retain the right to base judgments on information other than that in the guidelines. What will happen if a doctor practises outside of the guidelines? The content of CPGs pertain to the "usual" case, as CPGs are based primarily on evidence from randomised trials, which, because of inclusion and exclusion criteria and controlled clinical environments, produce an average result for the conditions studied. However, there may be many reasons for a clinician to provide care to an individual that departs from the guidelines' recommendations. The clinician may be aware of evidence other than that included in the guidelines, appraise the evidence differently to the guideline developers, be managing a person whose situation is different from that within the guidelines, or be treating a person who selects management outside of the guidelines. For example, the NHMRC's early breast cancer guidelines recommend that radiation therapy be offered after breast-conserving surgery. However, women who are carriers of a mutant ataxia telangiectasia (AT) gene have an extreme sensitivity to ionising radiation and can sustain severe normal tissue damage.8 In the rare case where a woman's AT status is known, radiation therapy would be best avoided. The paper concludes that:5 It is likely that departure from the practices advised in a guideline would be subject to the same test as any other departure from a generally accepted standard of care. Departure from practices recommended in guidelines because of ignorance of the guidelines would seem more likely to expose a doctor to risk of litigation, if a patient is damaged by a breach of the guidelines. Conscious departure from guidelines because of specific circumstances in a particular patient may be much easier to defend as consistent with an appropriate standard of care. If a clinician practises outside the guidelines, it is important to ensure that this is well documented and that appropriate strategies have been implemented. Recommendation of the forum: see point 5 (Box 2). Do consumer guides satisfy the criteria of informed consent? Australian law recognises the individual's fundamental right of self-determination,9 unless there is an overriding public policy issue to the contrary. Part of this is the right to have access to proper information on which to base decisions. Consumer versions of guidelines assist people by providing them with information about the choices available in their treatment. Just as a signed consent form is only considered to be one piece of evidence of consent, simply handing a patient a booklet about a particular condition or procedure is unlikely to be accepted as sufficient evidence of disclosure of risk by a doctor. There would also need to be evidence that the patient had had an opportunity to ask the doctor questions, as well as adequate opportunity to read and understand the material contained in the booklet. Recommendation of the forum: see point 6 (Box 2). Are guideline developers liable? Concerns have been raised that CPG developers such as the Australian Cancer Network, NBCC and NHMRC could be held liable if patient harm occurs as a result of a doctor following the guidelines. The NHMRC's Guidelines for the development and implementation of clinical practice guidelines addresses this issue:1 Normally a general publication, even where negligently collated, does not give rise to liability because the author does not owe a duty of care to the general public at large, although the guideline issuer could be held liable if a relevant close relationship can be established between them and the person who suffers a loss. If guidelines purport to be a definitive statement of the correct or appropriate procedure there would be a greater risk of liability than where the guidelines are expressly stated to be provided as a general guide subject to the medical practitioner's expert judgement in each case. As already outlined, guideline developers need to be able to demonstrate that the information in the guidelines has been properly developed and ratified. Additionally, the guidelines should clearly state that they are not a definitive statement, and note the date of development to make clear that the information is correct only to that date. Recommendation of the forum: see point 7 (Box 2). Where to next? The commissioned research paper and the forum agreed that changes should not be sought to the current legal status of guidelines. Rather, attention should be given to satisfying the criteria relating to appropriate development, ratification, evaluation and updating. If this is done, the likelihood of their acceptance within the current legal framework is enhanced. The general view at the forum was against legislating to define the status of guidelines within the legal framework. Rather, evidence-based guidelines should be used to inform the standard of care in courts of law. The forum recommended that a continuing legal education program be established to promote a better understanding in the legal profession of the role, development and use of CPGs among the legal profession. Recommendation of the forum: see point 8 (Box 2). Acknowledgements The authors would like to acknowledge the valuable contribution of The Hon. Justice Margaret Beazley of the NSW Court of Appeal to this paper. References 1. National Health and Medical Research Council. Guidelines for the development and implementation of clinical practice guidelines. Canberra: NHMRC, 1995. 2. Grimshaw J, Russell I. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993; 342: 1317-1321. 3. National Health and Medical Research Council. Clinical practice guidelines for the management of early breast cancer. Canberra: NHMRC, 1995. 4. Carrick SE, Bonevski B, Redman S, et al. Surgeons' opinions about the NHMRC clinical practice guidelines for the management of early breast cancer. Med J Aust 1998; 169: 300-305. 5. Hyams A, Brandenburg B, Lipsitz S, et al. Practice guidelines and malpractice legislation: a two way street. Ann Intern Med 1995; 122: 450-455. 6. Tito F, Newby L. Medico-legal implications of clinical practice guidelines. Sydney: NHMRC National Breast Cancer Centre, 1998. 7. Hurwitz B. Clinical guidelines and the law. BMJ 1995; 311: 1517-1518. 8. Appleby JM, Barber JB, Levine E, et al. Absence of mutations in the ATM gene in breast cancer patients with severe responses to radiotherapy. Br J Cancer 1997; 76: 1546-1549. 9. Review of professional indemnity arrangements for health care professionals [Tito F, chairman], Final Report. Compensation and professional indemnity in health care. Canberra: Commonwealth Department of Human Services and Health, 1995. Authors' details NHMRC National Breast Cancer Centre, Sydney, NSW Janet E Pelly, MA, Communications Manager. Liza Newby, LLB, MA, FAIM, former Health Services Commissioner, Victoria. Sally Redman, BA(Hons), PhD, Director. Enduring Solutions Pty Ltd, Waniassa, ACT. Fiona Tito, BA(Hons), LLB, Executive Director. NSW Department of Health, Sydney, NSW. Amanda M Adrian, RN, LLB, BA, Director, Private Health Care Branch.

Janet E Pelly · Liza Newby · Fiona Tito · Sally Redman · Amanda M Adrian

Use of complementary medicines: scientific and ethical issues We need to address questions of effectiveness, safety and regulation MJA 1998; 169: 180-181 This article has been cited in Rey JM, Walter G. Hypericum perforatum (St John's wort) in depression: pest or blessing? MJA 1998; 169: 583-586. The widespread acceptance of complementary medicines in Australia raises important scientific, social and ethical issues. The expression "complementary medicines" covers a diverse range of practices, from historically well-established therapies, such as traditional Chinese medicine, to more exotic forms, such as colour therapy and psychic healing.1 Taken together, the precise extent of their use is unknown. Certainly, the industry is a very large one: in the United States and Australia about one-fifth of the population visit alternative practitioners each year, and in Australia up to half the population have visited them at some stage.2-4 In the United States, expenditure on complementary therapies in 1990 was about $14 billion;3 for Australia, precise data are not available, but the figure is likely to be in the hundreds of millions of dollars.2,4 The use of complementary medicines is increasing. Again, data are scanty. However, over the last five years the number of raw medicinal substances imported for use in Australia has increased fourfold, and there are now about 300-400 individual medicines available.5 Since the introduction of a Medicare rebate for acupuncture in 1984, use of acupuncture by medical practitioners has increased greatly. By analysing one of the few reliable sources of data available, Health Insurance Commission records, Easthope et al,6 in this issue of the Journal, show that the number of Medicare claims for acupuncture services by general practitioners grew by nearly 50% in 12 years, to almost one million in 1996-97. Medicare reimbursements to doctors for acupuncture increased during this period from $7.7 million to $17.7 million, and in 1996 about 15% of general practitioners presented Medicare claims for acupuncture. Evidence regarding the clinical effectiveness of most complementary treatments, and the risks associated with them, is extremely limited.7,8 Randomised clinical trials have been few; indeed, it has been argued that complementary therapies in general, and traditional Chinese practices in particular, are in principle not susceptible to assessment using randomised-trial designs.7 In the case of acupuncture, significant insights have been achieved into physiological mechanisms of action; however, the few clinical studies that have been performed have often been flawed by poor design, inadequate measures and statistical analysis, and lack of follow-up data.7,8 Notwithstanding this, rigorous trials are possible, as has been shown by studies that support the use of acupuncture in the treatment of pain and nausea, and suggest possible applications in other areas, such as hypertension and asthma.7,8 It is important to recognise that complementary medicines, like orthodox ones, are not without risk. There is the possibility that use of complementary treatments might lead to withdrawal from appropriate medical therapy or to delays in diagnosis or treatment of underlying conditions. In addition, physical treatments can cause adverse effects, and herbal therapies can be either intrinsically toxic or contaminated with toxic substances. As recent discussions in the Journal have highlighted, serious reactions and even death can occur.8-11 Complications of acupuncture have included pneumothorax and puncture of other vital organs, spinal cord lesions, and infections (including HIV and hepatitis B),12,13 again associated with possible death.14 A National Health and Medical Research Council working party in 1989 found that complications occurred most frequently with acupuncturists without medical training.14 The widespread use of complementary medicines, and especially the application of acupuncture by general practitioners demonstrated by Easthope et al, raises some interesting social and ethical questions: It is widely accepted that individuals should be free to make their own choices with respect to healthcare; however, are not claims of cures matters of public interest affecting public health? Should the application of public funds be directed by consumer demand, or should it be limited to practices -- orthodox or complementary -- for which reasonable evidence of effectiveness and safety can be provided? Should the training and right to practise of complementary therapists -- at present largely unrestricted -- be subject to a formal system of regulation? Does the community have an obligation to protect vulnerable citizens from exploitation by practitioners holding uncertain qualifications, who apply practices with dubious benefits and unknown risks? Should special measures be introduced to protect children, especially from practices that may lead to their being denied conventional therapies of proven efficacy?15 Why have risk and lack of evidence not deterred potential patients and practitioners? The question of why people use complementary therapies is an important one which may have ethical implications of its own. There is evidence that people turn to alternatives because they are disillusioned with orthodox medicine. This may include dissatisfaction with doctor-patient interactions or dissatisfaction with medicine in general.16 Declining public support for hospitals and the introduction of economic practices such as managed care, which promote cost-saving at the risk of reducing the quality of service, may well exacerbate this process. Some form of regulation of complementary medicines seems to be necessary, but a delicate balance needs to be struck between control and consumer choice. A possible model, referred to as "protection of title", is presently under consideration in Victoria, following a government-sponsored inquiry into the practice of traditional Chinese medicine. It is believed that legislation will be introduced to limit the use of the titles "acupuncturist" and "practitioner of traditional Chinese medicine" to individuals who have been accredited by specified registration bodies. This approach would contribute to the establishment of standards of practice and training and provide avenues for aggrieved consumers to have their complaints addressed. Unregistered therapists could continue to practise as long as they did not claim to hold specific qualifications to do so. It is quite likely that some form of protection of title will eventually be adopted as a general approach to the regulation of various forms of complementary therapy throughout Australia. This approach, however, represents only a partial solution. It will still be necessary to consider whether therapies work and are safe -- and, indeed, whether this question can be answered at all. It will still be necessary for us to understand the cultural meaning of complementary medicines and what they have to teach orthodox practitioners. For these questions to be addressed, detailed research will be needed into not just the scientific but also the sociological, ethical and philosophical aspects of complementary medicines. It is to be hoped that such research will be undertaken, and that it will promote much-needed dialogue between practitioners of orthodox and complementary medicine. Paul A Komesaroff Associate Professor, Department of Medicine, Monash University and Director, Eleanor Shaw Centre for the Study of Medicine Society and Law Baker Medical Research Institute, Melbourne, VIC Eagle R. Alternative medicine. London: Futura, 1978. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States: prevalence, costs and patterns of use. N Engl J Med 1993; 328: 246-252. Ban E. Australian alternatives. Nat Med 1998; 4: 8. Myers S, Bensoussan A. Towards a safer choice: the practice of Chinese medicine in Australia. Sydney: Faculty of Health, University of Western Sydney, Macarthur, 1996. Easthope G, Beilby JJ, Gill GF, Tranter BK. Acupuncture in Australian general practice: practitioner characteristics. Med J Aust 1998; 169: 195-198. Vincent C, Furnham A. Complementary medicine: a research perspective. London: Wiley, 1997; 181-182. National Institutes of Health. Acupuncture. NIH Consensus Statement, April 1998. Mullins RJ. Echinacea-associated anaphylaxis. Med J Aust 1998; 168: 170-171. Kelly S. Aconite poisoning [letter]. Med J Aust 1990; 153: 499. Drew AK, Myers SP. Safety issues in herbal medicine: implications for the health professions. Med J Aust 1997; 166: 538-541. Halvorsen TB, Anda SS, Naess AB, Levang OW. Fatal cardiac tamponade after acupuncture through congenital sternal foramen [letter]. Lancet 1996; 345: 1175. Norheim AJ, Fønnebø V. Adverse effects of acupuncture [letter]. Lancet 1995; 345: 1576. National Health and Medical Research Council, Acupuncture Working Party. Acupuncture. Canberra: NHMRC, 1989. Neeley GS. Legal and ethical dilemmas surrounding prayer as a method of alternative healing for children. In: Humber JM, Almeder RF, editors. Alternative medicine and ethics. New Jersey: Humana Press, 1998; 163-194. Siahpush M. Postmodern values, dissatisfaction with conventional medicine and popularity of alternative therapies. J Sociology 1998; 34: 58-70. - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Paul A Komesaroff

Matters of life and death: the challenge of CPR decision making How can we improve patient involvement in this complex process? MJA 1998; 169: 124-125 Since its introduction in the 1960s and subsequent widespread dissemination, cardiopulmonary resuscitation (CPR) has saved the lives of many who would otherwise have perished. Today, whenever a patient's heart stops beating, carers are faced with an extraordinary choice. Either they may do nothing and allow the patient to die, or they may use CPR and try to breathe life back into the dying individual. How should this choice be made? Over the past 20 years numerous studies have sought opinions on this dilemma. In this issue of the Journal Kerridge et al report on the first Australian survey into the attitudes of hospital inpatients and staff.1 The authors used a simple cross-sectional design to quiz both patients and healthcare professionals at Newcastle's John Hunter Hospital. They sought attitudes on a range of matters concerning CPR and the decision-making processes that surround its use. Despite the study's shortcomings, such as relatively low response rates and the treatment of the study population as homogeneous, the results contain some interesting and apparently paradoxical findings. Although a large proportion of both patients and healthcare professionals felt that doctors should always ask patients whether they would like CPR, only a very small percentage of patients had actually discussed CPR with their doctors. This perplexing result mirrors the findings of international studies that surveyed far sicker inpatient samples. In two studies, Bedell and co-workers examined patients in Boston who had either required CPR or had been the recipients of do-not-resuscitate orders. Only about 20% of these patients had been involved in their own CPR decisions.2,3 Why is CPR decision making such a difficult issue, and what could be done to improve matters? The hardest thing about CPR decision making is the timing of the decision. Obviously, at the moment a patient requires CPR, he or she is unable to declare a preference about whether resuscitation should occur. Furthermore, patients usually lose their ability to consider CPR options well before the procedure is needed. Only about 20% of patients are competent at the time a do-not-resuscitate order is considered.3,4 Consequently, any patient input into the decision making process must be taken well before the final decision is needed. The patient must declare a position in advance. However, gaining a patient's preferences about CPR, and documenting them, is complicated by a series of other problems. Firstly, the details of advanced CPR and its efficacy are poorly understood by the general public. Providing patients with sufficient information to allow an informed decision is difficult and time consuming. It seems extremely unlikely that any simple method of seeking CPR preferences (upon, say, a patient's admission to hospital) would yield either valid or usable data.5 Secondly, advanced CPR involves a multitude of procedures and many patients may be willing to undergo some of these but not others.6 CPR decisions are not simple "yes or no" choices. Thirdly, although we know that likelihood of survival influences patients' preferences about CPR, it is often difficult to make predictions on the likelihood of benefit for any individual patient.5,7 These predictions become more difficult the longer the period between the prediction and the resuscitation. Fourthly, although people are inclined to believe that they can accurately predict whether they would want CPR in some future situation, this may not be the case. Weighing up risks and benefits hypothetically is quite different to weighing them up in reality. A number of lines of evidence suggest that, in general, the sicker people become the more likely they are to opt for intervention.8 Finally, although there is good evidence that patients find discussion of CPR neither cruel nor insensitive, discussions about death are frequently upsetting for patients and for their doctors.4 When there is no pressure for a CPR decision, it is no surprise that both patients and their doctors are disinclined to bring the matter up. In the face of so many obstacles, how are we to proceed? While guidelines, legislative initiatives, and targeted interventions may all have a role in improving the way CPR decisions are made, there are no simple answers to this dilemma. Generally, patient preferences about CPR must be the most important ingredients in CPR decision making, but these are hard to obtain and may not always be valid in a given situation. Even if one knows the patient's preferences, there can be no doubt that the complex nature of the factors that surround a decision to resuscitate will, on occasion, justify taking a course apparently contrary to the patient's wishes. The best CPR decisions will follow preparations that began long before the patient's heart was stilled. They will involve considered consultation with the patient, family and other healthcare professionals. They will require examination of the evidence relevant to the patient's predicament and they will rest on careful deliberation of all the issues of concern to that patient on that day. They will call forth the finest compassion but, for all of this, they will often fall short of a perfect result. Put simply, the best CPR decisions will involve the best clinical care, and providing that is the challenge for us all. Christopher J Ryan Consultation-Liaison Psychiatrist, University of Sydney, and Department of Psychiatry, Westmead Hospital, Westmead, NSW Kerridge I, Pearson S-A, Rolfe IE, Lowe M. Decision making in CPR: attitudes of hospital patients and healthcare professionals. Med J Aust 1998; 169: 128-131. Bedell SE, Delbanco TL. Choices about cardiopulmonary resuscitation in the hospital. When do physicians talk with patients? N Engl J Med 1984; 310: 1089-1093. Bedell SE, Pelle D, Maher PL, Cleary PD. Do-not-resuscitate orders for critically ill patients in the hospital. How are they used and what is their impact? JAMA 1986; 256: 233-237. Stolman CJ, Gregory OJ, Dunn D, et al. Evaluation of patient, physician, nurse and family attitudes toward do not resuscitate orders. Arch Intern Med 1990; 150: 653-658. Murphy DJ, Burrows D, Santilli S, et al. The influence of the probability of survival on patients' preferences regarding cardiopulmonary resuscitation. N Engl J Med 1994; 330: 545-549. Youngner SJ. Do not resuscitate orders: no longer a secret, but still a problem. Hastings Centre Report 1987; 18: 24-33. Frankl D, Oye RK, Bellamy P. Attitudes of hospitalised patients toward life support: a survey of 200 inpatients. Am J Med 1989; 86: 645-648. Ryan CJ. Betting your life: an argument against certain advance directives. J Med Ethics 1996; 22: 95-99. - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Christopher J Ryan

Decision making in CPR: attitudes of hospital patients and healthcare professionals Ian H Kerridge, Sallie-Anne Pearson, Isobel E Rolfe and Michael Lowe MJA 1998; 169: 128-131 For editorial comment, see Ryan Abstract - Introduction - Methods - Results - Discussion - Acknowledgments - References - Authors' details - - ©MJA1998 Abstract Objective: To examine the opinions of patients and healthcare professionals regarding the process of making decisions about cardiopulmonary resuscitation (CPR). Design and participants: A cross-sectional survey of 511 healthcare professionals (doctors, nurses and allied health professionals) (64% response rate) and 152 patients (58% response rate) at the John Hunter Hospital, Newcastle, New South Wales, in June 1994. Main outcome measures: Opinions on who should be involved in CPR decision making; what issues are important when making the decision; and how these decisions should be communicated. Results: 80% (95% confidence interval [CI], 72%-86%) of patients and 99% (95% CI, 98%-100%) of healthcare professionals (P < 0.001) thought patients' views should be taken into account when making CPR decisions. More patients (29%; 95% CI, 22%-38%) than healthcare professionals (14%; 95% CI, 11%-17%) indicated that doctors should be the main decision makers. Two-thirds of respondents regarded the patient's wishes, diagnosis and quality of life as important factors. Most respondents (82%) felt comfortable discussing CPR, but only 29% (95% CI, 22%-37%) of patients and 57% (95% CI, 52%-61%) of healthcare professionals had actually discussed CPR with others (P < 0.001). More than half of all respondents preferred to express their wishes about CPR in writing (47% [95% CI, 39%-55%] of patients, 69% [95% CI, 64%-73%] of healthcare professionals; P < 0.01); the others preferred to tell a family member or close friend. Most patients (60%; 95% CI, 52%-68%) and healthcare professionals (85%; 95% CI, 81%-88%) wanted their views in their medical records (P < 0.001). Conclusion: Most patients want to be involved in CPR decision making and many want some form of advance directive. Although there are some differences in opinions between patients and healthcare professionals, both perceive decision making at the end of life as a shared process, primarily involving the patient and doctor. Introduction Cardiopulmonary resuscitation (CPR) has been used in hospitals for about 30 years.1 Early studies of CPR in highly selected populations demonstrated its effectiveness and CPR soon became routine for any patient who died in hospital. However, as experience accumulated it became apparent that many patients, particularly those with chronic diseases, did not benefit from CPR. Hospitals responded by developing procedures for withholding CPR through the documentation of "do-not-resuscitate" orders. Decisions to initiate or withhold CPR were originally taken by doctors, but changing attitudes towards the doctor-patient relationship and the rise of medical consumerism have challenged this form of unilateral decision making. Indeed, respect for patient autonomy suggests that patients should have the right to contribute to such decisions. No Australian studies reported to date have examined patient preferences regarding CPR decision making. International studies suggest that most patients do not consider discussions about CPR preferences to be cruel or insensitive,2 and most wish to participate in decisions regarding CPR and other life-sustaining therapies.3 However, many patients are unable to participate during the final stages of life-threatening illnesses.4 The use of advance directives has been proposed as a means by which competent patients may ensure that their wishes will be carried out. Advance directives are written or verbal statements in which patients set out their preferences regarding life-sustaining treatment in case they later become incompetent. Advance directives have received considerable attention in the United States,5 where they have widespread legal recognition,6 but have received less publicity in Australia. In the absence of advance directives, CPR decisions are generally made by healthcare professionals in consultation with patients' families.7 The aim of this study was to compare the opinions of patients and healthcare professionals about several aspects of CPR: who should be involved in making the decision, what issues are considered important, and how these decisions should be communicated. Methods Survey We carried out a cross-sectional survey of healthcare professionals (doctors, nurses and allied health professionals) and patients at the John Hunter Hospital, Newcastle, New South Wales, in June 1994. The John Hunter Hospital is a 700-bed teaching hospital in an urban area. The survey formed part of a larger study that aimed to compare patients' and healthcare professionals' attitudes and knowledge about CPR. Survey questions were developed by reviewing published articles, incorporating questions from previously administered surveys,8,9 and consulting experts in the fields of ethics and questionnaire development. After pilot testing, the questionnaire was modified to incorporate the suggestions of a sample of patients and healthcare professionals at a local district hospital. The questionnaire included questions on sociodemographic information (age, sex, marital status, educational, religious and ethnic background) and self-reported health status. Respondents were then asked: whether doctors should ask patients if they would like CPR should they require it; whether patients have the right to choose or refuse resuscitation; who (from a list of people) should be involved in CPR decision making and who should be the main decision maker; which of eight issues listed were important in CPR decision making; whether discussing CPR was cruel or insensitive; whether they had discussed CPR and, if so, with whom; whether they would like patients' views about CPR to be expressed in writing before or soon after admission to hospital; and whether they would like patients' views about CPR to be included in medical records. The survey was administered to all healthcare professionals working over a two-day period at the John Hunter Hospital and to all eligible inpatients over an adjacent two-day period. Self-complete questionnaires were delivered by hand and collected as soon as they had been completed. Patients were initially screened by one of the principal investigators in consultation with a nursing unit manager and excluded if they were regarded as unable to complete the questionnaire or could not understand English. The remaining patients were asked by trained interviewers to participate. After consent was obtained, a Mini Mental State Examination (MMSE) was carried out to assess cognitive status. Patients with an MMSE score less than 24 were excluded, as this may indicate incompetence.10 Statistical analysis Data were analysed with SPSS for Windows.11 Continuity-corrected chi-square analysis was used to compare the sociodemographic variables and the responses of patients and healthcare professionals for each questionnaire item. Ethical approval The Hunter Area Health Service Research Ethics Committee and the University of Newcastle Research Ethics Committee approved the study. Results Respondents Of the 803 questionnaires delivered to hospital staff, 511 were returned -- a response rate of 64%. Of these respondents, 148 were doctors, 312 were nurses and 51 were from other healthcare professions, including physiotherapy, social work, occupational therapy, speech therapy and nutrition and dietetics. There were 443 adult patients in the John Hunter Hospital at the time of the study; 183 were excluded because of dementia, neurological impairment or delirium (110 of those excluded), incompetence (35), visual problems (24), psychiatric illness (9), or because they were undergoing procedures (5). Of the 260 remaining patients, 152 completed the questionnaire -- a response rate of 58%. Healthcare professionals were more likely than patients to be younger, female, have tertiary qualifications and report being healthy. Healthcare professionals and patients did not differ in terms of marital status, religion or ethnic background. Patient involvement in CPR decision making Patients and healthcare professionals differed significantly in their responses to whether doctors should ask patients if they would like CPR should they require it (P < 0.001): 23% (95% confidence interval [CI], 16%-30%) of patients and less than 1% (95% CI, 0-2%) of healthcare professionals thought that doctors should never ask patients, whereas 30% (95% CI, 22%-37%) of patients and 41% (95% CI, 37%-46%) of healthcare professionals thought that they should always ask patients. The remaining respondents were unsure or thought it depended on the patient's circumstances. There was also a significant difference in the way healthcare professionals and patients responded regarding the right to choose or refuse CPR (P < 0.001): 32% (95% CI, 25%-40%) of patients and 1% (95% CI, 0-2%) of healthcare professionals felt that patients should never have this right. Fewer patients (34%; 95% CI, 26%-42%) than healthcare professionals (67%; 63%-71%) believed that patients should always have the right to choose or refuse resuscitation, and the remaining respondents thought it depended on the patient's circumstances. Who should be involved in decision making More than 80% of patients and healthcare professionals indicated that patients and their doctors are important in CPR decision making (Table). Approximately half the respondents regarded the patient's partner and family members as important, but only a third regarded nursing staff as important decision makers. Interestingly, 47% (95% CI, 41%-52%) of nurses believed that they should be involved, whereas only 23% (95% CI, 16%-31%) of doctors and 24% (95% CI, 13%-37%) of allied health professionals believed that nurses should be involved. A significantly lower proportion of patients than healthcare professionals indicated that patients and their partners are important in making the decision. Approximately two-thirds of respondents identified the patient and less than one-third identified the doctor as the person who should be the main decision maker. There was a significant difference in the way healthcare professionals and patients responded. Fewer patients (55%; 95% CI, 47%-63%) than healthcare professionals (85%; 95% CI, 82%-88%) thought the patient should be the main decision maker, whereas 29% (95% CI, 22%-38%) of patients but only 14% (95% CI, 11%-17%) of healthcare professionals thought the doctor should be the main decision maker. The other respondents identified nurses, partners or family members. Important factors in the decision The patient's wishes, diagnosis and quality of life were identified by at least two-thirds of all respondents as important factors in CPR decision making (Figure). Patients were less likely than healthcare professionals to regard patient's wishes (P < 0.001), diagnosis (P < 0.001) and quality of life (P < 0.001) as important, but were more likely to regard age (P < 0.001), family wishes (P < 0.01), mental state (P < 0.03) and social circumstances (P < 0.01) as important. Discussing CPR Most respondents (82% in both groups) did not think discussing CPR was cruel or insensitive. Although 92% (95% CI, 86%-96%) of patients and 96% (95% CI, 94%-97%) of healthcare professionals (P < 0.001) indicated that they had family members who could make decisions for them if they were unable to, only 29% (95% CI, 22%-37%) of patients and 57% (95% CI, 52%-61%) of healthcare professionals (P < 0.001) had discussed with others whether they would like CPR. For all respondents, any discussions that had taken place were with partners (37%; 95% CI, 33%-41%), and/or family members (26%; 95% CI, 23%-30%) and/or doctors (3%; 95% CI, 2%-4%). Advance directives More than half the respondents (47% [95% CI, 39%-55%] of patients, 69% [95% CI, 64%-73%] of healthcare professionals; P < 0.01) preferred to express their wishes about CPR in writing before or soon after being hospitalised. The remaining respondents preferred to tell a family member or close friend about their wishes. About two-thirds of all respondents indicated that they would like their views about CPR to be part of their medical records. Fewer patients (60%; 95% CI, 52%-68%) than healthcare professionals (85%; 95% CI, 81%-88%) wanted their views in their medical records (P < 0.001). The remaining respondents were either uncertain or did not wish to have their views as part of their records. Discussion We found that many patients want to be involved in CPR decision making and many want some form of advance directive. Patients and healthcare professionals generally think that decisions about CPR should be shared by doctors and patients, with patients more likely to feel that doctors should be the main decision maker in such circumstances. This study has several flaws. The study uses a self-report questionnaire, and the low response rate among patients suggests that the group may not have been representative of the population as a whole. Indeed, there is likely to have been a systematic bias towards those who were willing to discuss CPR. Despite this, the findings of this study are of interest, particularly as the study sampled inpatients and had methodological strengths, including a process for the assessment of patient competence and the use of trained interviewers who were not members of the patients' own healthcare team, and thus less likely to influence their participation in the study or their responses to the questions about CPR. International studies have demonstrated that most patients would like to be involved in CPR decision making.12 Layson et al, reviewing international published studies, found that 52%-87% of patients had considered their preferences for life-sustaining therapy (CPR and admission to intensive care) and wished to discuss their preferences with their doctors, but few did so.13 We found that 80% of patients believed they should be involved in CPR decisions, but only 29% had discussed CPR with their doctors or their families. Forty-seven per cent of patients in this study would have liked to express their wishes regarding CPR in writing, either before admission or shortly after. The remainder preferred to tell a family member or a close friend. However, very few patients reported giving advance directives. There are few data to validate routine use of advance directives in hospitals. In the largest study to date that looked at the introduction of advance directives in routine care, their use did not affect patient-physician communication, physician's knowledge of patient preferences, the number of patients receiving ventilation or the use of hospital resources.14 Interestingly, that study was based upon the extensive use of nurses to assess patient preferences and communicate these results to physicians. Hospital staff appear to place more importance upon the role of patients in CPR decision making than patients do. This has been noted in previous studies of patient preferences about decision making,15,16 leading commentators such as Ende et al to suggest that the current emphasis upon patient autonomy arises more from normative ethical reasoning than from patients' actual preferences.16 Other researchers suggest that this is a misconception arising from combining several different aspects of decision making into a single question. Deber and Baumann suggest that shared decision making has two parts:17 problem solving, in which an expert identifies diagnostic and treatment options and expected risks and benefits, and decision making per se, in which the doctor and patient together determine an appropriate course of action.18 According to Deber et al, "given the choice between abiding by the decisions of a paternalistic provider and being handed a stack of medical books and being told to figure out what they wish to do, most patients unsurprisingly opt to hand over control to a trusted provider".18 Both these options are probably inappropriate, and if given a wider choice patients are unlikely to opt for unilateral decision making. Our study suggests that, despite differences between the views of healthcare professionals and patients, the overwhelming majority of both groups support patient and doctor involvement in shared decision making about CPR. Who else should be involved in CPR decision making? Both patients and healthcare professionals believe that partners and some family members should be involved. Surprisingly, only 36% of patients believed that nurses should be involved in these decisions. The reasons for this are likely to be complex. There is no doubt that nurses have a genuine stake in discussions about resuscitation. When a patient has a cardiac arrest, nurses are faced with an ethical decision: to follow their own ethical standards, or to follow the protocols documented in patient notes and hospital procedures, if such documentation exists. Within this context it is interesting to note that in a recent study of American critical care nurses 16% reported that they had participated in euthanasia or assisted suicide, many without the knowledge of physicians, patients or patients' surrogates, and 4% reported that they had hastened a patient's death by only pretending to apply life-sustaining treatment ordered by a physician.19 Nurses are independent moral agents, and there are good reasons for nurses to be involved in CPR decision making. However, there are considerable practical difficulties as nurses care for patients in shifts, and it is not possible to involve every nurse who looks after a patient. It is clearly inadequate to include only one nurse, and then to document "nursing staff in agreement". Perhaps some of this uncertainty filters through to patients. Without continuity of nursing care, patients are unlikely to consider nurses to be major participants in CPR decision making. In addition, the professional image of nurses as moral agents in their own right may not have been communicated adequately to patients or other healthcare professionals. Either way, this finding challenges the notion of "nurse as patient advocate". Differences between staff and patients in preferences about CPR decision making may influence the way decisions are made in hospital and limit the capacity for healthcare professionals to act as patient advocates. This suggests that the proper role for advance directives and the process of CPR decision making requires further study. The effect of determinants such as age, health status, education and religion on CPR decision making also requires further research. Simplistic assertions of autonomy or of the theoretical moral or legal value of advance directives without consideration of the importance of care, compassion or clinical context are clearly inappropriate. This study suggests that both healthcare professionals and patients see decision making at the end of life as a complex, shared process rather than a sterile abstraction of expert information disclosure followed by patient self-determination. Acknowledgements We wish to acknowledge student research assistants from the Faculty of Medicine and Health Sciences for their assistance with data collection and the staff and patients of the John Hunter Hospital for their generous participation in this study. References Robertson GS. Resuscitation and senility: a study of patients' opinions. J Med Ethics 1993; 19: 104-107. Stolman CJ, Gregory OJ, Dunn D, Levine JL. Evaluation of patient, physician, nurse and family attitudes toward do not resuscitate orders. Arch Intern Med 1990; 150: 653-658. Reilly BM, Magnassen R, Ross J, et al. Can we talk? Inpatient discussions about advance directives in a community hospital. Arch Intern Med 1994; 154: 2299-2308. Bedell SE, Pelle D, Maher PL, et al. Do-not-resuscitate orders for critically ill patients in the hospital: how are they used and what is their impact? JAMA 1986; 256: 233-237. Council on Ethical and Judicial Affairs. American Medical Association. Guidelines for the appropriate use of do-not-resuscitate orders. JAMA 1991; 265: 1868-1871. Fisher RH, Meslin EM. Should living wills be legalised? CMAJ 1990; 142: 23-26. Hare J, Pratt C, Nelson C. Agreement between patients and their self-selected surrogates on difficult medical decisions. Arch Intern Med 1992; 152: 1049-1054. Frankl D, Oye RK, Bellamy P. Attitudes of hospitalised patients toward life support: a survey of 200 inpatients. Am J Med 1989; 86: 645-648. Murphy DJ, Burrows D, Santilli S, et al. The influence of the probability of survival on patient's preferences regarding cardiopulmonary resuscitation. N Engl J Med 1994; 330: 545-549. Folstein MF, Folstein SE, McHugh PR. Mini-mental state. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189-198. SPSSx statistical package for the social sciences [computer program]. Version 6.0. Chicago, Ill: SPSS Inc, 1990. Morgan R, King D, Prajapati C, Rowe J. Views of elderly patients and their relatives on cardiopulmonary resuscitation. BMJ 1994; 308: 1677-1678. Layson RT, Adelman HM, Wallach PM, et al. Discussions about the use of life-sustaining treatments: a literature review of physicians' and patients' attitudes and practices. J Clin Ethics 1994; 5: 195-199. The SUPPORT Principle Investigators. A controlled trial to improve care for seriously ill hospitalised patients. JAMA 1995; 274: 1591-1592. Strull WM, Lo B, Charles G. Do patients want to participate in medical decision making? JAMA 1984; 252: 2990-2994. Ende J, Kazis L, Ash AB. Measuring patients' desire for autonomy: decision making and information seeking preferences among medical patients. J Gen Intern Med 1989; 4: 23-30. Deber RB, Baumann AO. Clinical reasoning in medicine and nursing: decision-making versus problem-solving. Teach Learn Med 1992; 4: 140-146. Deber RB, Kraetschmer N, Irvine J. What role do patients wish to play in treatment decision making? Arch Intern Med 1996; 156: 1414-1420. Asch DA. The role of critical-care nurses in euthanasia and assisted suicide. N Engl J Med 1996; 334: 1374-1379. (Received 14 Jul 1997, accepted 1 Apr 1998) Authors' details Faculty of Medicine and Health Sciences, University of Newcastle, NSW. Ian H Kerridge, BMed, MPhil, Lecturer in Clinical Ethics, Clinical Unit in Ethics and Health Law, and Haematology Registrar, John Hunter Hospital; Sallie-Anne Pearson, BSc(Hons), Professional Officer, Programme Evaluation Committee; Isobel E Rolfe, FRACP, MRCP, Senior Lecturer in Medical Education; Michael Lowe, BMed, Tutor in Clinical Ethics, and Medical Registrar, John Hunter Hospital. Reprints will not be available from the authors. Correspondence: Dr I H Kerridge, Clinical Unit in Ethics and Health Law, John Hunter Hospital, Locked Bag 1, Hunter Regional Mail Centre, Newcastle, NSW 2310. E-mail: ikerridgeATmail.newcastle.edu.au - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Ian H Kerridge · Sallie-Anne Pearson · Isobel E Rolfe · Michael Lowe

Prescribing heroin: nothing to fear but fear itself? Illicit drug policy based on punitive measures has failed, and it is time to seek a healthcare approach MJA 1998; 168: 590-591 The worsening global problem of illicit drugs will have been under discussion at the United Nations General Assembly Special Session on Drugs (UNGASS) in New York this month (8-10 June), just a few days before this issue of the Journal is published. The international crisis to which the United Nations is responding reflects decades of preferring to view the world as we would like it to be rather than as it is. Despite decades of alarming deterioration in outcomes associated with illicit drugs, the International Day Against Drug Abuse and Illicit Trafficking (26 June) is likely to be marked by yet more grandiloquent pronouncements of unachievable goals. In another editorial in this issue, Manderson describes the evolution of the complex drug control web in which we are now caught.1 Whenever new evidence has emerged of increasing illicit drug production and poorer outcomes, the reflex response of the international community has been to attempt to even more vigorously reduce supply. Genuine efforts to develop evidence-based alternative approaches, such as the proposed Australian Capital Territory heroin trial in 1997, have all too often been resisted by politicians. Senior Australian law enforcement officers have recently begun to question the traditional reliance on efforts to control illicit drug supply, with some calling for greater emphasis on treatment.2 After a recent meeting, Australian police commissioners "formally agreed to consider a range of strategies focusing on rehabilitation and avoiding the criminal justice system".2 Victorian Police Chief Commissioner, Mr Neil Comrie, said commissioners had decided to "almost wipe the slate clean" on current strategies.2 Australian criminal intelligence experts have stated that "law enforcement efforts are having only a limited effect on the amount of heroin offered at street level", and concluded that "it is obvious that current policies are not working".3 Some health interventions against illicit drugs, such as methadone treatment and needle exchange programs, have proved remarkably effective. Pharmacological treatments, of which methadone is by far the most important, attract and retain a substantial proportion of drug users and are strongly supported by evidence of safety and effectiveness.4 As both drug users and the broader community benefit substantially by recruitment and retention of users in treatment, the allocation of additional funding for monitoring and evaluation of trials of new pharmacological treatments in the recent "tough on drugs" statements by the Prime Minister should be warmly welcomed. These treatments include the partial opioid agonist buprenorphine, two opioid agonists (sustained-release oral morphine [SROM] and l-a-acetyl-methadol [LAAM]) and the opioid antagonist naltrexone. Each of these agents has particular advantages compared with methadone: buprenorphine and LAAM are safer and offer less costly alternate-day dispensing; SROM does not accumulate; and naltrexone avoids euphoria or dependence. However, there is no current evidence that these agents are more attractive or effective than methadone. By contrast, some trials have found that treatment retention, which often correlates well with other outcomes, was better for prescribed heroin than for methadone.5-7 There is a long history of pharmacological therapy for illicit drug users. More than 40 government clinics prescribed injectable morphine in the United States between 1919 and 1923.8 Heroin prescribing to treat heroin dependence commenced in the United Kingdom in 1926 and continues today,8 although this practice has been uncommon and rarely evaluated. A surprisingly extensive practice of prescribing amphetamine to amphetamine-dependent patients exists in the United Kingdom (Philip Fleming, Consultant Psychiatrist, Portsmouth Drug and Alcohol Service, Southsea, Hampshire, UK, 1998, personal communication), but is poorly documented and insufficiently evaluated. In this issue of the Journal, Metrebian and colleagues present the results of a UK study of relatively intractable patients allowed to choose treatment with either injectable heroin or injectable methadone.9 This study provides further support for the feasibility of prescribing heroin. The fact that more than one-third of patients chose injectable methadone should reassure those who assume that heroin prescription will prove irresistible to heroin injectors. Diversion of prescribed heroin to others was apparently not a problem, even though some prescriptions were dispensed weekly. Retention in treatment was unimpressive, but these patients had previously proved refractory to multiple treatment modalities. Illicit drug use, injecting risk behaviour, criminal activity, social functioning, health status and psychological adjustment all improved. Although the authors did not compare prescription of injectable drugs with other treatments, this study provides further support for conducting rigorously designed heroin trials. Whether prescribed heroin is suitable only for a heroin-dependent subgroup who do not respond to oral methadone or could be extended successfully to selected treatment-naive heroin users is a question that may also need to be answered one day. Right now, the study by Metrebian et al is also of interest in Australia because the harmful practice of methadone syrup injection is becoming increasingly common, and it is conceivable that parenteral methadone prescription might prove less harmful. The rationale for evaluation of medical prescription of heroin is based mainly on the need for dramatically improved treatment outcomes. The results of the recently completed heroin trial in Switzerland showed impressive health, social and economic gains,7 although the lack of a control arm inevitably limits any conclusions. Patients all had extensive histories of previous unsuccessful attempts at treatment (including methadone treatment). Retention on heroin prescription was considerably better than contemporary national retention rates for oral methadone treatment (although better staffing of the experimental program makes such comparisons problematic). After the Swiss heroin trial, 71% of voters in a national referendum supported continuation of this treatment, with majorities in all 26 cantons. It is hard to think of any new intervention in the illicit drug area in the last quarter-century that has shown such promise. On 6 June this year, the New York Academy of Medicine hosted the first international scientific meeting on heroin trials, reflecting growing international interest. A heroin trial will commence soon in the Netherlands, with trials under consideration in the UK, Germany, Spain, Austria and Canada.10 Interestingly, police chiefs in 10 of the 12 largest cities in Germany have been pressing for such a trial.10 The increasing interest in heroin trials is partly the result of authorities' growing acknowledgement of the failure of current policy. Were responses to illicit drugs to be decided entirely on the basis of evidence rather than fear and rhetoric, Australia would now be awaiting the results of the pilot stage of the ACT heroin trial. Demand for heroin is currently met by adulterated supplies of unknown concentration obtained from criminals. It seems probable that drug users and the general community would be better off if at least part of this demand were met by sterile heroin of known concentration prescribed by medical practitioners. Most doctors faced with a complex, chronic, relapsing-remitting disorder would prefer to choose from a range of effective treatments rather than rely on a single agent. The trials of new pharmacological agents are likely to extend and improve our therapeutic repertoire for treating heroin dependence. And there is still a compelling case for proceeding with a scientifically rigorous Australian heroin trial when political factors allow. Alex Wodak Director, Alcohol and Drug Service St Vincent's Hospital, Sydney, NSW Manderson D. Drug abuse and illicit trafficking. Med J Aust 1998; 168: 588-589. Harris T. Police switch strategies in war on drugs. The Australian 25-26 Apr 1998: 9. Australian Bureau of Criminal Intelligence. Australian illicit drug report 1996-97. Canberra: The Bureau,1997. Ward J, Mattick R, Hall W. Methadone maintenance treatment and other opioid replacement therapies. Amsterdam: Harwood Academic Publishers, 1998. Hartnoll R, Mitcheson M, Battersby A, et al. Evaluation of heroin maintenance in controlled trial. Arch Gen Psychiatry 1980; 37: 877-884. McCusker C, Davies M. Prescribing drug of choice to illicit heroin users: the experience of a UK community drug team. J Substance Abuse Treatment 1996; 13: 521-531. Uchtenhagen A. Summary of the synthesis report. In: Uchtenhagen A, Gutzwiller F, Dobler-Mikola A, editors. Programme for a medical prescription of narcotics: final report of the research representatives. Zurich: Institute for Social and Preventive Medicine, University of Zurich, 1997. Rihs-Middel M, editor. The medical prescription of narcotics. Scientific foundations and practical experiences. Seattle: Hogrefe and Huber. 1997. Metrebian N, Shanahan W, Wells B, Stimson GV. Feasibility of prescribing injectable heroin and methadone to opiate-dependent drug users: associated health gains and harm reductions. Med J Aust 1998; 168: 596-600. Nadelmann E. Commonsense drug policy. Foreign Affairs 1998; Jan/Feb: 111-126. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Alex Wodak

Unemployment and health: the healthcare system's role Elizabeth Harris, Ian W Webster, Mark F Harris and Penelope J Lee Experts from the South Western Sydney Area Health Service and the University of New South Wales say there are few r eports of healthcare interventions to address the impact of unemployment on health. They outline possible strategies, which include providing accessible and appropriate healthcare; developing the health care system's capacity to deal with the health problems of unemployed people; collaborating with other agencies and sectors working on this issue; acting as an advocate for unemployed people; undertaking research; and providing training, work experience and employment opportunities within the healthcare system. Long term solutions lie in increasing employment and training opportunities. Nevertheless, there is a clear role for the healthcare system in reducing the health impacts of unemployment and ensuring that poor health does not act as a barrier to returning to work. (MJA 1998; 168: 291-296) Introduction - GPs' experience of the health impact of unemployment - Opportunities for action - Conclusion - References - Authors' details - - ©MJA1998 Introduction The health problems of unemployed people1,2 find their way daily into general practitioners' (GPs') consulting rooms and hospitals, and so are a legitimate concern to all health workers and policymakers. The challenge in addressing this issue is to define an effective role for the healthcare system which both promotes employment and reduces its health impacts. Experience gained in addressing other health-related problems with their roots in our social and economic environments (eg, road injury or the health of indigenous people) suggests that action will be needed at many levels both within and outside the healthcare system. Healthcare provided for unemployed people should: Adequately address their existing health problems; Focus on prevention and anticipatory care; and Ensure that health problems do not act as barriers to a return to work. It will also involve work with other sectors and community groups to meet the needs of unemployed people in the local community and to bring the high social and economic costs of the detrimental effects of unemployment on health to the attention of government and the community. Here we examine possible practical action that can be taken by mainstream health services to reduce the impact of unemployment on health. GPs' experience of the health impact of unemployment Differences in the presenting health problems of unemployed and employed people are not subtle. In a GP waiting room survey in outer Sydney, unemployed people were significantly more likely than employed people to report poorer health, depression, anxiety, insomnia and limitations to their social activities due to physical and mental health problems, after adjusting for age, sex and English-speaking or non-English-speaking background3 (Figure, below). There is also evidence that people who are unemployed have, or develop, chronic health problems that act as barriers to a return to work.1,4,5 Differences in management by GPs have been found between employed and unemployed people; people who are unemployed are more likely to be prescribed medication for depression and anxiety by GPs, and to be less frequently referred to self-help groups.6 Opportunities for action Despite all the evidence of an association between unemployment and health, review of the health research literature revealed few examples of health service interventions to reduce the impact of unemployment on health: one described an employment initiative for mental health service users in Wales, and a second documented health service providers' views of unemployment and their response to unemployment issues.7,8 Some studies describe the impact of training programs on health and employment outcomes.9,10 Thus, up to now, the focus has been on defining the association between unemployment and health and little attention has been paid to developing or evaluating interventions within the healthcare system to prevent or reduce the health impacts of unemployment. We currently have little understanding of what are the most appropriate responses. We need more thorough evaluation of current strategies within the healthcare system for addressing this issue, and opportunities to study successful interventions in similar health-related areas.11,12 Possible strategies are listed in Box 1 and described below. Providing accessible preventive care and management of health problems In the South Western Sydney Area Health Service, we have developed standards for GP management of the health problems of unemployed people. In the process, a high level of agreement was found between unemployed people, community groups and GPs on the possible role for primary care workers. GPs were seen as having a central role in providing comprehensive management of existing health problems and anticipatory care, building the capacity of their patients to solve health-related problems and ensuring referral to relevant services (Box 2). GPs trained in these standards have gained confidence in managing the problems of their unemployed patients, and increased their knowledge of local services.13 Further work on assessing the impact of use of the standards on patient health outcomes is required. Patients with chronic health problems require particular attention, as these problems may lead to unemployment or act as significant barriers to re-employment. The job security of people who are limited by mental or physical conditions is increasingly at risk as the labour force contracts, and stressful working conditions may exacerbate existing disabilities, especially mental disability. Building the capacity of the healthcare system to address unemployment Healthcare services must be accessible and affordable. Medicare has improved access to general practice, but access of unemployed people to healthcare may be limited by the costs of private medical treatment, imaging and prescriptions. For example, people who are unemployed are more likely to experience mental health problems.14,15 The cost of private psychiatric services is high and publicly funded mental health services may give low priority to problems such as anxiety, depression, emotional instability and social isolation, to which unemployed people are more prone. Furthermore, more unemployed people live in geographic areas where public health services are in limited supply (such as the western suburbs of Sydney and Melbourne, and in rural areas). An ever-present problem is that even healthcare workers are not immune to prejudices against unemployed people. This can result in a lack of sensitivity to the range of problems faced by unemployed people and how they can be addressed, different medical treatment being given to unemployed people, and unjust assumptions being made ("all they want is a quick fix"). One way to deal with these prejudices is by providing pre-service educational programs that require medical, nursing and allied health students to undertake case studies of the health and social problems faced by unemployed people. Working with other agencies and departments to reduce the impact of unemployment on health and increase the chances of finding work Many healthcare workers already informally collaborate with other services to address the needs of particular individuals or families. A more formal and systematic collaboration is needed to prevent job loss whenever possible, to reduce the impact of unemployment on health, and to ensure that existing health problems do not become a barrier to returning to work. Establishing better relationships between service providers can prevent the different ways organisations do business from compounding the problems (eg, making arrangements for managing drug or alcohol dependence can improve unemployed people's ability to concentrate on training programs). Action can also be directed at providing skills and resources to other organisations, and supporting them in addressing the needs of their unemployed clients. Skillshares (community-based training providers for unemployed people) provide an important venue for health service providers to make contact with unemployed people. The Division of General Practice Southern Tasmania has developed an innovative program in which GPs regularly provide health education for Skillshare participants.16 At evaluation of this program, both the confidence of participants in dealing with the health system and their knowledge of factors that improve health were increased. Several recent studies have found that introduction of short courses to improve problem-solving skills and reduce negative feelings and beliefs had positive and long-lasting impacts on psychological health, and also increased the number of people who found work.10,17 With experience gained from these projects, the South Western Sydney Area Health Service is working with Skillshares to promote early detection and referral of health problems, to increase the skills and knowledge of participants in making healthy life choices, and to build psychological resilience and coping strategies. Acting as advocates for unemployed people to government and the wider community Health workers have an important role in advocating on behalf of their patients. For people who are unemployed, this may involve intervening in decisions that have been made by government departments (eg, loss of benefits), dealing with other institutions (eg, negotiating for a priority housing listing), or asking for special support and assistance (eg, requesting assistance with paying electricity bills). More generally, the healthcare system can highlight the impact of unemployment on health and challenge stereotyping of unemployed people as lazy or "dole bludgers". It is in this area that the role of the health sector in preventing health problems can be most effective. Because appreciable changes in employment opportunities in Australia require political action, it is important that the contribution is not only in defining the problem but also in providing leadership in directing change. Continuing to research the impact of unemployment on health and to evaluate interventions There is a need for further research to explain the nature of the link between unemployment and ill-health -- the complex interplay of poverty, stress, social support, lifestyle risk factors, pre-existing disease and access to or use of healthcare services. There also needs to be a substantial shift away from defining the problem to developing and evaluating interventions that may reduce the health impact of unemployment. At a policy level the health costs associated with unemployment need to be better documented; in part to justify the reorienting of healthcare services to address the needs of unemployed people, but also to ensure that these costs are added into any evaluation of unemployment costs to the community. Providing training, work experience and employment for unemployed people The healthcare system is one of Australia's largest employers. Many NSW health services have made significant contributions to providing training, work experience and ultimately employment for local unemployed people. The second-largest employer in south-west Sydney, the South Western Sydney Area Health Service (SWSAHS), in collaboration with the federal Department of Employment, Education, Training and Youth Affairs, has established both training programs for long term unemployed, and a routine referral system to the Commonwealth Employment Service for SWSAHS job vacancies in certain areas (eg, clerical and catering, as well as laboratory technicians and ward orderlies). This has resulted in over 100 unemployed people being placed in the Area Health Service. The benefits of such programs lie not only in the employment and training opportunities that they provide, but also in building up organisational commitment to addressing the health problems of unemployed people.18 Conclusion The healthcare system can and should be expected to play a significant role in reducing the impact of unemployment on health and ensuring that health problems do not act as barriers to people returning to work. Unemployment is not a disease and should not be medicalised. However, its impact on health needs to be more formally recognised by the healthcare system in the way we deliver and plan services for individuals and populations. It also needs to be made clear to governments and the community that the long-term solution to these health problems will not be found in hospitals or GP surgeries, but in the creation of employment and training opportunities for all Australians who want to work. The medical profession in this country has provided real leadership on this issue in the past: the AMA organised conferences and seminars in 1995; and both the AMA and the Public Health Association have made submissions to parliamentary committees and attempted to raise community awareness through media publicity. The need to provide leadership has not diminished. References Mathers CD, Schofield DJ. Health consequences of unemployment: the evidence. Med J Aust 1998; 168: 178-182. Morrell SL, Taylor RJ, Kerr CB. Unemployment and young people's health. Med J Aust 1998; 168: 236-240. Harris E, Lee P, Fisher R, et al. Unemployment and health in general practice. Sydney: School of Community Medicine, UNSW, 1995. Smith R. Unemployment and health: a disaster and a challenge. Oxford: Oxford University Press; 1987. Jinn RL, Chandrakant PS, Tomislav JS. The impact of unemployment on health: a review of the evidence. Can Med Assoc J 1995; 153: 529-540. Harris MF, Silove D, Kehag E, et al. Anxiety and depression in general practice patients: prevalence and management. Med J Aust 1996; 164: 526-529. Hutchings J, Gower K. Unemployment and mental health. J Mental Health 1993; 2: 606-607. Mason RA, Boutilier MA. Unemployment as an issue for public health: preliminary findings from North York. Can J Public Health 1995; 86: 152-154. Vinokur AD, Van Ryn M, Gramlich EM, et al. Long-term follow-up and benefit-cost analysis of the Tabs program: a preventive intervention for the unemployed. J Appl Psychol 1991; 76: 213-219. Proudfoot J, Guest D, Cars J, et al. Effect of cognitive-behavioural training on job-finding among long-term unemployed people. Lancet 1997: 350: 86-100. National Health and Medical Research Council. Health Advancement Standing Committee. Promoting the health of Aboriginal and Torres Strait Islander communities -- case studies and principles of good practice. Canberra: NHMRC, 1997. National Health and Medical Research Council. Health Advancement Standing Committee. Promoting the health of Australians: case studies of achievements in improving the health of the population. Canberra: NHMRC, 1997. Harris E, Harris M, Fisher R. Unemployment and health. A guide for general practitioners. Sydney: Fairfield Division of General Practice and School of Community Medicine, UNSW, 1995. Warr P. Work, unemployment and mental health. Oxford UK: Oxford University Press, 1987. Fryer D. The experience of unemployment in the social context. In: Fischer S, Reason J, editors. Handbook of life stress, cognition and health. New York: John Wiley and Sons, 1988: 211-237. The Division of General Practice Tasmania Southern Region, and Glenorchy Skillshare Inc. GP health education to Skillshare jobseekers. New Town (TAS): The Division of General Practice Tasmania Southern Region, 1994. Creed PA, Machin MA, Hicks R. Neuroticism and mental health outcomes for long-term unemployed youth attending occupational skills training programs. Person Individ Diff 1996; 21: 537-544. South Western Sydney Area Health Service. Nomination for the NSW Premier's Award for excellence in public policy. Sydney: South West Sydney Area Health Service, 1997 . This is the final article in a series on unemployment and health (see also MJA 1998; 168: 177, 178 and 236) Authors' details South Western Sydney Area Health Service (SWSAHS), Sydney, NSW. Elizabeth Harris, BA, DipSocWk, MPH, Deputy Director, Centre for Health Equity Training Research and Evaluation; Penelope J Lee, BA, BCA(Hons), Research Officer, Unemployment and Health Project. School of Community Medicine, University of New South Wales, NSW. Ian W Webster, MD, FRACP, FAFPHM, Professor of Public Health; and Director, Division of Population Health, SWSAHS; Mark F Harris, MD, FRACGP, Professor of General Practice; and Director, General Practice Unit, SWSAHS. Reprints will not be available from the authors. Correspondence: Professor M F Harris, General Practice Unit, Fairfield Hospital, Fairfield, NSW 2165. E-mail: m.f.harris AT unsw.edu.au - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Elizabeth Harris · Ian W Webster · Mark F Harris · Penelope J Lee

Reforming the law on expert evidence The process of reform should involve the medical profession MJA 1998; 168: 53-54 Nowhere in the interface between medicine and the law is conflict more evident than in court. Although the two disciplines appear to have one thing in common -- to seek "the truth" -- the truth as relevant to medicine may well differ in nature from the truth as relevant to the law. Further, the approaches used by the two disciplines to establish their respective truths are fundamentally different. Common law process is based on an adversarial system in which opposing parties present evidence to a judge or jury who determine the outcomes. Litigants construct their cases largely by selecting evidence that is advantageous to themselves, rather than the "absolute truth". In contrast, Western medicine is based on scientific evidence. It seeks to establish its "truth" through rigorous scientific methods which are foreign to the legal profession in its training and practice. In the curial interface between medicine and the law, science is moulded into an uneasy and unnatural use within a system of intellectual combat alien to the scientific method. Enmeshed in this process are expert witnesses. The task of the expert witness was characterised by The Hon. Gordon Samuels, Governor of New South Wales and past President of the New South Wales Court of Appeal, in his 1997 AMA (NSW) Oration Medical truth and legal proof (in this issue of the Journal). He described this task as twofold: "to furnish basic scientific or technical data", and "to present inferences and conclusions from the facts which the judge or jury, for lack of specialised knowledge, cannot draw themselves".1 The duty of experts is to the court. They should impartially assist the court to understand the technical evidence, and not act as champions or advocates for the instructing and paying party. Understandably, some experts may find it difficult to recognise the need for impartiality and to accept this need if they have assisted in preparing the case before trial. The challenge to the trial judge is to ensure that the expert is qualified on the issue before the court and that only relevant and reliable opinions are accepted from that expert. The problem is that the procedural rules relating to evidence permit the judge a wide-ranging power of discretion to carry out these duties. There is no threshold test in common law for the admissibility of expert evidence which takes into account its reliability. Evidence could be given by an academic with limited practical training, by a retired practitioner who has not practised for many years, or indeed by anyone with a recognised general medical degree without regard to specialisation. The discretion exercised by judges in some recent Australian trials has resulted in decisions which have caused concern in the medical community. The following cases are illustrative. In Woods v. Lowns & ors,2 the issue was whether it was reasonable for the defendant paediatric neurologist not to have prescribed rectal diazepam for epilepsy in a child in 1987. The plaintiff's expert from the United Kingdom asserted that the omission to prescribe rectal diazepam fell short of the standard of good medical practice, although he was aware, and the court accepted, that it was universal practice of paediatric neurologists in Australia in 1987 not to prescribe this form of the drug. Although this expert was expressly criticised by the trial judge for acting as an advocate for the plaintiff rather than as an independent witness, his evidence might appear to have influenced the resulting judgment. Secondly, in Curtin v. Holliday & anor,3 a specialist oncologist gave evidence on the issue of early diagnosis of breast cancer by a general practitioner. The evidence of an expert in the advanced treatment of cancer is arguably irrelevant and perhaps unreliable in relation to the standard of practice applicable to a general practitioner. Thirdly, the evidence of a general surgeon on a renal physician's treatment of rhabdomyolysis was admitted by the judge in a jury trial,4 despite the surgeon's forced concession that he had never treated the condition, nor been involved in its management, and had not discussed such a condition at a scientific meeting. The general surgeon was arguably not qualified to provide the required evidence at issue. Governor Samuels' oration discusses reform initiatives on the use of expert evidence in the United States and their potential application in Australia. The US Supreme Court, in Daubert v. Merrell Dow Pharmaceuticals, considered the issue of scientific validity of expert testimony.5 The decision outlined indicators which would assist a court in determining scientific reliability: whether the assertion can be and has been tested; whether the theory or technique has been subjected to peer review and publication; and the known or potential rate of error. These indicators represent a move away from the pre-existing test (widely, but not universally, in use in the US), which refers to mere "general acceptance" within a relevant scientific community. While this US decision has no direct applicability in Australia, the test for reliability may be a useful model for procedural reform. Reforms have also been suggested in the UK, where Lord Woolf, Master of the Rolls, was appointed in 1994 to review the civil justice system in England and Wales. In his interim report, Lord Woolf recommended that the court should have "complete control" over the calling of expert evidence.6 This recommendation was reaffirmed, despite some opposition, in Lord Woolf's final report.7 In October 1996, the Chief Justice of the Federal Court of Australia, Michael Black, made some proposals regarding the use of expert evidence, and called for submissions from the Australian Law Council and other "professional bodies in the fields of economics, patents, trade marks, copyright, engineering and accounting".8 The Federal Court's initial proposal mirrored Lord Woolf's recommendation (above), but has since been amended to state that "the calling of expert evidence would usually be subject to the control of the parties, with the Court taking some control in exceptional cases".9 Other elements of the proposal included development of a code of conduct for experts, the requirement that expert evidence be addressed to the court, and the use of a panel of experts in a manner similar to that used with apparent success by the Australian Competition Tribunal. In this Tribunal, expert economists submit written statements before the oral proceedings. At the conclusion of all the evidence the experts give their opinions on the issues arising from the evidence and on the opinions of the other experts. They are entitled to modify their written views as much as they wish, so that the Tribunal can hear their present views after having access to all the evidence. In addition, the Australian Law Reform Commission is including the issue of expert evidence in its review of the adversarial system of litigation in federal courts and tribunals.10 The Australian and UK initiatives are aimed at modifying the role of experts in the adversarial arena, so that they can metaphorically wear their laboratory or clinical coats rather than advocates' robes. The initiatives are likely to encourage judges to be more active as assessors, and thereby to make the common law system less adversarial. Interestingly, provisions in the New South Wales Supreme Court Rules permit, but do not oblige, judges to appoint their own experts.11 In practice, these provisions have been rarely used, except in some patent cases. Other possible reforms to the laws on expert medical evidence could include: The addition of a reliability threshold test, such as that outlined in the US Daubert decision; The requirement that evidence of accepted practice or standard within a specialised area be given only by someone with qualification and currency of practice in that specialised area; The involvement of learned medical colleges in establishing panels of accredited experts to be available to litigants and the courts, and in formulating a code of conduct for expert witnesses; and The adoption of some of the better elements of the Roman inquisitorial process in relation to expert evidence, such as the use of court-appointed experts or expert assessors to sit with, and advise, the judge. The gap between medicine and the law is at its widest in the adversarial system of law. The proposals being considered by the Federal Court and the Australian Law Reform Commission should not be left entirely to the legal profession and the legislators, without input from other learned professions. Given the frequency of personal injury claims and the importance of medical expert evidence in these claims, the medical profession should take a significant role in the reform process. Richard T T Tjiong Chairman United Medical Protection, Sydney, NSW Samuels G. Medical truth and legal proof. Med J Aust 1998; 168: 84-87. Woods v. Lowns & ors. Unreported, NSW Supreme Court, No. 14529, 9 Feb 1995. Curtin v. Holliday & anor . Unreported, NSW Supreme Court, No. 20147/96, 19 Dec 1996. Ford v. Garrick , NSW Supreme Court, No. 15966/88, 1994. Daubert v. Merrell Dow Pharmaceuticals 113 Sct 2786 (1993). The Right Honourable the Lord Woolf. Access to justice: interim report to the Lord Chancellor on the civil justice system in England and Wales. London: HMSO, 1995: 192. The Right Honourable the Lord Woolf. Access to justice: final report to the Lord Chancellor on the civil justice system in England and Wales. London: HMSO, 1996: 139. Black CJ. Letter to the Australian Law Council, dated 24 October, 1996. Available from the Registrar, Federal Court of Australia, Sydney, NSW. Black CJ. Letter to the Australian Law Council, dated 20 August, 1997. Available from the Registrar, Federal Court of Australia, Sydney, NSW. Australian Law Reform Commission. Review of the adversarial system of litigation. Issues Paper 20. Canberra: AGPS, April 1997: 7.76-7.79. New South Wales Supreme Court Rules, Parts 39.2, 39.3. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Richard T Tjiong

Ethics Towards a consensual culture in the ethical review of research Donald Chalmers and Philip Pettit, on behalf of the Australian Health Ethics Committee The Report of the Review of the Role and Functioning of Institutional Ethics Committees was submitted to the Minister for Health and Family Services in March 1996.1 It recommended, among other things, that the Statement on Human Experimentation, issued under the name of the National Health and Medical Research Council (NHMRC) in 1992, should be revised. A similar recommendation was made in the report by Dr Margaret Allers in 1994 into the collection, manufacture and injection of human growth hormone.2 The recommendation for a review of the Statement was approved by the Council in November 1996. The Australian Health Ethics Committee, a Principal Committee of the NHMRC, had for some time been discussing various aspects of the Statement on Human Experimentation and independently decided that the Statement should now be revised. The Committee's first consideration was the tone that the Statement should set for the ethical review of research. This article expresses the Committee's views on this matter. MJA 1998; 169: 79-82 Introduction - The goal of ethical review - The path we should be taking - The path we are actually taking - Recommendations for the reform of ethical review - References - Footnote - Authors' details - - More articles on Ethics Introduction The evolution of an ethic among those conducting research on humans has occurred in three stages. First, individual researchers developed a general sense of what was proper behaviour and what was improper behaviour in the pursuit of research goals - in particular, with regard to the treatment of research subjects. Then, professional research bodies (which first appeared in the last century) articulated codes of behaviour for their members. Finally, independent authorities - universities, hospitals, governments - institutionalised the ethical review of research projects that fell within their purview.3,4The forces driving this evolution are complex; we draw attention to one that may easily escape notice. This is a social mechanism that we describe as the "controversy machine". Some research is pursued in an ethically dubious fashion, or with ethically deplorable results. The whistle is blown by an insider, or a newspaper or community group comes to learn by another means what is happening. There is a public scandal, leading to popular demand that something be done to make sure this never happens again. The professional bodies, or other authorities, respond to the demand by taking appropriate action, or at least action accepted as appropriate. Things quieten down, but then, perhaps years later, another scandal is uncovered and the process runs its course once more. The controversy machine played a major role earlier this century in the development of codes of research conduct; these codes were formulated in the first wave of reaction to various scandals in research on humans. It has also played an important part in the last 20 years or so in facilitating the introduction and then the gradual formalising of arrangements for the review of research proposals. With every subsequent scandal made public, ethical surveillance was made more rigorous (Box 1). The controversy machine has been at the origin of many fine achievements in social life, being associated in various countries with the development of a more or less decent civic and public world.9However, the controversy machine does not invariably work for good. In some areas the responses that scandals elicit - and that serve best to satisfy public outrage - are not necessarily the responses that deal most effectively with the underlying problem. For example, the controversy machine may be responsible for the widespread failure of governments to deal humanely and effectively with criminal offenders. Scandals in the criminal justice area - the heinous crime, the offence under parole - tend to generate a get-tough reaction that satisfies public outrage without actually being very effective. Because the controversy machine has been responsible for generating our system of ethical review of research, we who are charged, at whatever level, with running that system should be clear about where exactly we want to get to and whether we are on course for getting there. We need to consider, first, the goal of ethical review; second, the path that we should be taking in pursuit of that goal; and, third, the extent to which we are cleaving to that path. Otherwise, we are in danger of being carried along, unthinkingly, by a process that may do more harm than good. The goal of ethical review One view of the goal of ethical review of human research would be that it is to reduce, as far as possible, the incidence of unethical research. The best way of realising that goal would be to prevent any research whatsoever occurring: no research, ergo no unethical research. But it is important to see that this cannot possibly be right, and no one in the business of ethical review has ever thought that we would have achieved our goal - as distinct from putting ourselves out of a job - if we got rid of research altogether. Any plausible system for ethical review of human research must have as its goal, not only that research should be ethical, but also that research should continue to be pursued. It must be designed, not as a form of ethical inquisition, but, rather, as a system for facilitating and encouraging ethically informed research on humans. There are two models for facilitating ethically informed research. The first is to identify certain ethical standards - inevitably, certain less than fully determinate standards - and, taking scientific value as given, to encourage those projects that in the committee's judgement satisfy the standards. The second is to make a judgement about how scientifically valuable the research is and to encourage research to the extent that (i) it is judged to be both scientifically worthwhile and ethically satisfactory, and (ii) considering the balance between these two aspects, it scores pretty well in the opinion of the committee. The first of these models is more attractive than the second.2 Ethics committees are not necessarily well equipped to determine the scientific quality of the research projects they consider. In fact, it is often quite hard to make a judgement on whether a project is worthwhile or not, and it is clearly wrong for a non-professional group to take on the burden of this judgement. Besides, it would be a source of reasonable resentment and alienation on the part of researchers if a committee that was meant to judge the ethical acceptability of research projects insisted also on making judgements of a methodological character. Of course, ethics committees may require an assurance that any project submitted is of scientific interest. They might, for example, insist on a prior assessment of the risks attendant on the research, as well as the potential benefits to be gained by it. And in difficult cases where special problems arise (e.g., when the research involves the use of placebos with patients who seem certain to die without the drug under trial) they may reasonably seek an assurance that the project really does hold out a firm promise of achieving the alleged benefits. But such assurance should always be sought outside, from an adequately informed authority; otherwise, the committee is going to look like an arbitrary power. The goal we should be pursuing, then, is an arrangement under which ethics committees obtain judgements of scientific merit from elsewhere and work to facilitate all those meritorious projects, and only those, that meet certain ethical standards. The ethical standards will require, among other things, that the subjects are voluntary and suitably informed participants in the enterprise; that the risk of harm to those subjects, or to others affected, is not inappropriate; and that considerations of confidentiality and privacy are reasonably satisfied. Such standards are often going to be difficult to interpret and apply, which is why we mentioned their not fully determinate character. One way in which they will be difficult to apply is that, in judging whether a risk of harm is appropriate, the committee will have to make an assessment of the importance of the benefits promised by the research, according to the scientific assessment: it will have to make a judgement, not on what the potential benefits are, but on how much significance to attach to them. The path we should be taking There are two broadly contrasting approaches that ethics committees might take in pursuing the goal of facilitating ethically informed research. The first is to encourage patterns of ethical self-evaluation among researchers, and to rely on this as the normal means of ensuring ethical conduct. Thus, while routinely overseeing all that happens, and implementing relevant procedures and being available for consultation about them, they would take an interventionist stance only in exceptional cases. The second approach is to adopt an inspectorial and adversarial role in relation to researchers, seeking to articulate an exact code and to make maximum efforts to police that code in every instance. Two facts argue strongly against going the adversarial way.9-11 No system of inspection and policing, no matter how draconian, could hope on its own to achieve a high level of ethical conduct among resistant researchers; there will always be opportunities for researchers to take shortcuts and bend the rules, if they are so inclined. An adversarial system of inspection and policing is likely to make researchers resistant to considerations of ethics; it is likely to put them offside, as they see themselves demeaned and distrusted by the agencies of ethical review. The better prospect for facilitating ethically informed research is the alternative, non-adversarial, approach. This begins from the assumption that most researchers, once they are made aware of ethical concerns, are disposed to take them seriously; only a small minority are likely to ignore them in their enthusiasm for their research goals. The strategy is to build on this strength by generating an awareness of ethical concerns in the research community at large and, without abdicating the position of ultimate authority in ethical matters, by displaying a posture of trust in that community. What would this posture of trust involve? A number of possible initiatives will illustrate the idea; the list offered is meant to be suggestive, not definitive. Invite relevant individuals and bodies to give advice on the ethical problems most prominent in their area, and negotiate about difficulties that individual researchers may find in dealing with their ethics committee. Delegate some degree of responsibility for ethical review to professional departments or agencies; for example, allowing them to review projects coming to the committee, and working towards a situation in which the committee is almost always happy with anything that the professionals approve. Communicate the reservations of the ethics committee to any researcher whose project seems to raise problems and seek to work out ways of getting around those problems, consistent with the aims of the project. Develop a common understanding with the relevant research communities about what is a reasonable period for ethical review and try systematically to complete the review of projects within that period. Seek to devise a system of monitoring that does not communicate a sense of being under surveillance and suspicion to researchers. Encourage the relevant professional bodies to assume responsibility for keeping their members informed about ethical issues and for organising discussion of those issues. The path we are actually taking These considerations about the goal of ethical review, and about the best means of pursuing it, are not entirely uncontroversial. Still, they are likely to attract a broad consensus among those concerned with the ethics of human research, in particular among those with some sense of the difficulties associated with regulation, and of the possibility of regulation becoming counterproductive. They lead us now to ask whether the path we are actually taking in ethical review - the path on which the controversy machine has set us - is likely to prove adversarial or non-adversarial in character. Unfortunately, it doesn't require much reflection to see that the controversy machine has left us with a system of ethical review that is in danger of becoming extremely adversarial. The fact that the system orginated in reaction to scandal, and is legitimated as a protection against further scandal, projects two assumptions of an adversarial character. Researchers are regarded as the source of ethical problems: they are cast in the role of potential offenders. And reviewers are regarded as those with the unique responsibility, and the unique power, to prevent those problems arising: they are cast in the role of protectors and police. Under this interpretation of the two sides - and it is not yet a reality, only a threatening scenario - researchers get to be seen as one-sidedly interested in research goals, reviewers as equally one-sidedly interested in ethical standards. The review process is presented as a struggle between those of a single scientific mind, who want to pursue their research ambitions at any cost, and those of a single ethical mind, who have to try to keep the researchers honest. There is no room left in the scenario for the possibility of the two sides coming to a common mind on relevant matters. Not only does the origin of the system in the controversy machine project assumptions of an adversarial character, but also the possibility of the machine being called into action serves to reinforce an adversarial relationship between reviewers and researchers. The system we have at present puts reviewers under threat of being themselves exposed to public censure in the event of approving a research project that gives rise, fairly or unfairly, to a scandal of some sort; that is, it imposes a heavy penalty on a positive mistake: a mistake in approving what perhaps should not have been approved. However, the system in place imposes no such penalty on a negative mistake: a mistake in not approving what should have been approved. Thus, the system creates a conflict of interest between reviewers and researchers; it gives the reviewers a special incentive for taking the cautious line that goes against the interests of the researchers. These effects of the controversy machine on our system of ethical review have the potential to be very damaging. Here is a list of some possible consequences. We stress that these are possible consequences, not results that have actually been documented; what they constitute is a "watch-list" for those who have a responsibility for ethical review. Ethical reviewers see research as the concern of researchers, ethics as their own concern, and so do not worry about the effects of their reviewing on research activity. In particular: they may have no hesitation in refusing to approve research projects that raise any difficult questions; they may delay and obstruct research projects that they approve, through being excessively procedural and legalistic; and they may be willing to see the traditional agenda of research being seriously cut back, if that is where their deliberation leads. Ethical reviewers are unwilling to contemplate a "steady state", in which research generally satisfies the accepted ethical standards and ethics committees play an ever more passive role. In particular: as research projects meet accepted standards, reviewers begin to make those standards more demanding, exploiting the indeterminacy mentioned earlier: they become tougher on questions to do with what is an acceptable risk of harm, on what is adequate information for research subjects to be given, and so on; and ethical reviewers begin to look for further ways of monitoring the extent to which researchers stick to ethical guidelines: they begin to assume a greater surveillance and policing role. Researchers respond to this indifference, and this incremental creep, by adopting a resistant posture. In particular: they become alienated from the process of ethical evaluation, as they come to think of ethics as the reviewers' business, not their own; they see it as perfectly legitimate to do whatever is necessary in order to bypass the standards imposed on them; they may even take positive pleasure in defying and defeating the reviewers; and they develop a collective mentality of this resistant kind and become disposed to close ranks under any scrutiny from outside; whistle-blowers are a thing of the past. Recommendations for the reform of ethical review It would be a great tragedy if our system of ethical review became adversarial under the pressure of the controversy machine that helped to spawn it. We do not believe that the system has yet assumed a fully adversarial profile, but there is a danger that it may be headed in that direction. It is therefore important at this juncture to try to reshape it. We conclude with some broad-gauge suggestions about the steps that need to be taken. Before offering those recommendations it may be useful to stress that they are all compatible, in our view, with the fundamental role of the ethics committee in protecting the interests of those affected by research and the interests of the community as a whole. While it is important that ethical review should not have an adversarial cast and should not assume an obstructive role, it is even more important that its role should not be compromised in any way. We believe that our suggestions (Box 2) do not threaten any compromise; on the contrary, we think, for reasons already indicated, that their implementation should help to further the ends of ethical review. These proposals are certainly not exhaustive of the things that might be done to make sure that the course of ethical review, despite its origins in the controversy machine, does not assume an adversarial direction. A widespread discussion among reviewers and researchers would be necessary to generate a full sense of the initiatives available. We hope that such a discussion will materialise and that the adversarial trajectory will not win out by default. References Report of the Review of the Role and Functioning of Institutional Ethics Committees. Canberra: AGPS, 1996. Allers M. Inquiry into the use of pituitary drug hormones in Australia and the Creutzfeldt-Jakob Disease. Canberra: AGPS, 1994. Gillespie R. Research on human subjects: an historical overview. Bioethics News 1989; 8 Suppl: 4-15. McNeil P. The ethics and politics of human experimentation. Cambridge: Cambridge University Press, 1993: 15-84. The Nuremberg Code. JAMA 1996; 276: 1691. Beecher H. Ethics and clinical research. N Engl J Med 1996; 274: 1354. Furrow B. Health law. New York: West Publishing, 1995: 839-841. Pettit P. Institutionalising a research ethic: chilling and cautionary tales. Bioethics 1992; 6: 89-112. MacDonagh O. A pattern of government growth 1800-60. London: Macgibbon and Kee, 1961. Ayres I, Braithwaite J. Reponsive regulation. New York: Oxford University Press, 1992. Grabosky P. Counterproductive regulation. Int J Sociol Law 1955; 24: 347-369. Sunstein CR. Paradoxes of the regulatory state. University of Chicago Law Review 1990; 57: 407-441. Footnote This paper represents the consensual view of the Australian Health Ethics Committee as that view was developed over the triennium 1994-1996. It was revised in the light of discussions in the Committee itself, and at a number of workshops throughout Australia in 1995, and was approved for publication by the Committee. Authors' details Law Faculty, University of Tasmania, Hobart, TAS. Donald Chalmers, LLM, Chair, Australian Health Ethics Committee 1994-. Research School of Social Sciences, Australian National University, Canberra, ACT. Philip Pettit, LPh, PhD, member, Australian Health Ethics Committee, 1994-1996. No reprints will be available from the authors. Correspondence: Professor P Pettit, Research School of Social Sciences, Australian National University, Canberra, ACT 0200. E-mail: pnpATcoombs.anu.edu.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Medical truth and legal proof Changing expectations of the expert witness Gordon Samuels MJA 1998; 168: 84-87 Introduction - Matters of opinion - The role of the expert - Expert qualifications - From adversaries to truth... - Science v Law - Expert error - Judging the experts - References - Authors' details - - ©MJA1998 Introduction When Dr Julian Lee wrote inviting me to give the 1997 AMA (NSW) Oration, he suggested that I might care to address the relationship "between our two professions and its current implications". Plainly, one of the two professions to which he referred was that of medicine. The other could scarcely have been the profession of Governor, which, so far as I am aware, lacks the formal structure, the need to have survived rigorous inquiry into some intellectual qualification and the right of self-regulation which normally denote a profession. So I concluded that he was referring to the profession which I pursued in a former incarnation when I was, as most of you will know, a barrister and, later, a judge. As a lawyer in both of those roles I enjoyed close professional relationships with the medical profession. As a barrister I was retained by a medical insurer and did my best to act as shield and buckler for those doctors -- in those days a small number -- who had the misfortune to find themselves in the courts as defendants. I often relied on the expert evidence of medical practitioners, and on different occasions did my best to destroy the testimony of others. As a judge I sat on varied cases involving doctors in one capacity or another, and throughout the time I much enjoyed the intellectual comradeship presented by the Medico Legal Society of New South Wales and the Australian Academy of Forensic Sciences. It seemed to me, however, that what Dr Lee had in mind was the professional relationship which exists between the medical and the legal professions, and which links them as the leading participants in the litigious process in the courts. It is to that aspect which I propose to direct my remarks tonight. Despite changes in the procedure for recovering damages for injury sustained on the roads and in the workplace, such actions remain regular fixtures in the common law lists. It follows that doctors are still the expert witnesses who are most in demand, and their evidence is the scientific testimony most commonly presented to the courts. I propose to say a word or two about expert witnesses and their evidence, with particular reference to medical witnesses, and to describe shortly the way in which our current forensic procedure prescribes how that evidence is to be given and its cogency tested. Then I will say something about the problem which exercises -- I might say, in some cases, agitates -- both doctors and lawyers of ensuring that expert testimony is of a standard which the court may accept and act upon. There has been a recent decision of the Supreme Court of the United States,1 which, although not directly of authority in Australia, may well produce a substantial effect upon the way in which Australian courts in the future assess and admit scientific evidence, including, of course, evidence concerning medical science. Matters of opinion Expert witnesses have not always enjoyed a good reputation. They have tended to present the same image in legal literature as the lawyer does in Shakespeare: venal, grasping and fit to be hanged. The following acrid passage is a fair sample: "These witnesses are usually required to speak, not to facts, but to opinions; and when this is the case, it is often quite surprising to see with what facility, and to what extent, their views can be made to correspond with the wishes or the interests of the parties who call them." That observation comes from the celebrated text book Taylor on evidence, but there are judicial comments to the same effect, referring, for example, to the "kind of unconscious bias which is a well known characteristic of expert evidence".2 However, judicial comment has also included pleasing accolades, such as those bestowed in a case in New South Wales upon medical witnesses who were demonstrating with singular tenacity the philosophical dichotomy between physician and surgeon.3 The physicians who gave evidence preferred proof by scientific means; the surgeons by experience and observation. Some of the criticism made of the expert witness may be justified. But, in all fairness, it should be shared with the lawyers, who have cast expert witnesses in a particular role which they often find uncomfortable and restricting. It was the lawyers who originally altered the expert's function from that of assessor to that of witness. The allegation of undue adherence to the client's cause is made by those who have created, and who perpetuate, the forensic techniques to which the expert has been forced to adapt. It is not the expert's own choice to be a partisan, but a consequence of the pressures and temptations exerted by the adversarial system in which he or she has to play a part. The role of the expert The function of expert witnesses is to inform the tribunal, judge or jury, of matters about which its lack of specialist skill or experience would leave it ignorant. It is intended to substitute knowledge for speculation. The duty of the expert has been defined in this way: "...to furnish the judge or jury with the necessary scientific criteria for testing the accuracy of their conclusions so as to enable the judge or jury to form their own independent judgement by the application of these criteria to the facts proved in evidence."4 The expert's task is twofold. First, to furnish basic scientific or technical data. Second, to present inferences and conclusions from the facts which the judge or jury, for lack of specialised knowledge, cannot draw themselves. The expert is introduced to carry the proof to the conclusion for which the party presenting that evidence contends. But the limits of the role are drawn where the expert's special knowledge ceases to be significant. Expert qualifications Before the expert can perform the assigned function, he or she must be qualified to furnish the evidence to be tendered. This question of qualification rarely presents itself in the average case where the evidence of doctors, engineers and accountants, let us say, is primarily concerned. It is not the qualification to give the evidence which has generated recent controversy, but rather the quality of the evidence which a qualified expert offers. The High Court of Australia has dealt in detail with the skill necessary to qualify a witness as an expert, and with the circumstances in which the testimony of a skilled person is admissible. The putative expert must have undertaken a professional course of study which has given him or her more opportunity of judging the matters in question than other people; or must have completed the professional study of what has been described as "an organised branch of knowledge" relevant to the subject matter of the inquiry.5 A leading text writer on the law of evidence has suggested that the only true criterion is whether "on this subject can [the tribunal] from this person receive appreciable help".6 The standard to be applied is somewhat indefinite; and from this it follows that any medical practitioner may be (and nearly always is) admitted to give evidence upon any branch of medicine. And one can always be found who will. It is unfortunately true that the law does not require the best possible witness as it requires the best possible evidence; and the safeguard is said to be the good sense of the tribunal of fact which must itself determine which of the witnesses it will accept. Up to the present, Australian law has not contained any criterion for evaluating the quality of expert evidence as a threshold element to be satisfied as a test for admission. In the average case where there is a conflict of medical evidence, the dispute is most often about a commonplace medical condition in which specialised support for any of the assertions that might be made may readily be found. In the unusual case, the most novel proposition will have its adherents, who may compensate in vehemence for what they may lack in scientific authority. There is a prime example of this situation, and of the difficulties of applying any stringent limitation upon the testimonial capacity of persons prima facie qualified. The issue in a case was whether the deceased's acute lymphatic leukaemia had resulted from trauma. The evidence of a doctor was admitted (and accepted by the jury) which answered the question affirmatively, on the footing of a scientific phenomenon known to the witness as "autonomic dyspraxia", but not at all within the professional experience of any of the eminent practitioners who gave evidence on the other side.7 From adversaries to truth... The nature of expert evidence and the way in which it is given will be largely determined by the procedure of the court; and its effect is greatly influenced by the capacity of the court to understand and apply it. The basic forensic procedure which applies, with variations, in all Australian courts is the adversarial system or procedure. Its essence is that the parties, and not the court, determine the issues which they will fight, and themselves select and call the evidence in support of them. The cases are generally conducted by advocates for the parties, and, as a general rule, the judge's intervention is, and is intended to be, comparatively minor. It is thus the responsibility of the parties to prepare their cases and marshal their witnesses. The court provides the formal means, backed by sanctions, by which the witnesses may, if necessary, be summoned to the trial and documents procured for inspection and tender. It is an essential consequence of the adversarial system that the parties are not obliged to call all the relevant evidence which they may have in their possession. They are entitled to call only that which favours their own case, and, with certain important exceptions, may properly not disclose that which does not. Traditionally, the adversarial trial has been regarded as a gladiatorial combat, and sporting metaphors abound. They are not always accurate, but, as Lord Devlin has observed,8 our system is a trial of strength rather than an inquiry on the European model produced by the traditions of the Roman law, in which the judge, rather than the parties, conducts and controls the proceedings as an inquisitor rather than a referee. Since our mode of trial does not involve painstaking and wide-ranging investigation conducted by an impartial inquisitor, it is not designed to ferret out the truth in any absolute sense. The judge, for example, is limited by the material which the parties choose to offer; and, in a criminal case, save in the most exceptional circumstances, is not permitted to call a witness of his or her own motion.9,10 Although the position in Australia is uncertain, there is authority for the view that in a civil action the prohibition upon the judge's calling a witness is absolute.11-14 The adversarial trial is, above all, intended to produce a winner. In our system the question is not "What is the truth of the matter?". It is not "Who killed X?". It is not even "Did the accused kill X?". It is "Has the prosecution proved beyond reasonable doubt that the accused killed X?", because the issue is whether the party carrying the burden of proof has discharged it. I think that in most cases the adversarial conflict does elicit the truth, but it cannot be regarded as designed to do so. Science v Law The procedure adopted in our courts tends to exacerbate fundamental differences in approach between doctors and lawyers. Medicine is a science and law is not. Developments in medicine are made by experiment and observation; in law they are made by the decisions of legislatures and judges. A medical fact is one which can be empirically supported or clinically determined; a legal fact is one which is more probable than other countervailing facts. A trial lawyer seeks to win by tipping the scales of proof in his or her favour by the preponderance of cogent evidence. Hence, the search is for positive answers and firm conclusions; for the means of establishing the proposition that will prove the issue in dispute and end the case. Beyond that the lawyer has no commitment. Thus, lawyers often find difficulty in dealing with the expert, whether forensic scientist or medical practitioner, who does have a continuing commitment to the search for a final answer which, nevertheless, the scientific methodology tends to deny. Karl Popper has said: "When we think we have found an approximation to the truth in the form of a scientific theory which has stood up to criticism and to tests better than its competitors, we shall, as realists, accept it as a basis for practical action, simply because we have nothing better (or nearer to the truth). But we need not accept it as true; we need not believe in it (which would mean believing in its truth)."15 Furthermore, the details of forensic procedure place restrictions sanctioned by the rules of evidence upon the scientist's, and the doctor's, accustomed method of exegesis and description. The need to deploy closely reasoned opinion by means of question and answer, and the danger of fatal disconnection if the interrogating counsel is inept or the judge's interventions unduly copious, are not designed to promote lucidity. Further, expert witnesses are irritated by the way in which cross-examining counsel is able to detach and attack certain portions of their evidence or force them into logical qualifications. An expert witness, of course, whatever the field, needs to bear in mind the necessity of separating ego from opinion. Expert error Against this background some alarm has been generated in recent years by a number of cases in the United Kingdom and Australia in which a miscarriage of justice (that is to say, a wrong result) has occurred as a result of the admission of highly dubious scientific evidence. In a paper which I delivered to the Australian Academy of Forensic Sciences in 199116 I cited the "Chamberlain Case" in Australia, in which a Royal Commission finally established that some of the vital evidence for the prosecution was simply wrong;17 the case of "The Birmingham Six" in England where, again, the scientific evidence and the methodology used to produce it were fatally flawed;18,19 and finally the case of "McLeod-Lindsay", in which scientific developments subsequent to the trial refuted the evidence upon which the case for the prosecution largely depended.20 The question raised by instances of this kind is how does "bad" scientific evidence -- what is known as "junk science" in the United States -- get into the court room? How does it find its way into evidence and thus into the deliberations of the tribunal? Some commentators would answer that instantly by ascribing it to judicial incompetence, and the evasion by judges of their responsibility to evaluate expert testimony.21 Another view is that "scientific test evidence is frequently misused in criminal trials because of its unreliability".22 I think that the problem is complex, but I do not have the space here to analyse it. However, it is possible that the judges are about to modify their methods of dealing with expert evidence. Judging the experts A recent decision of the United States Supreme Court (Daubert v Merrell Dow Pharmaceuticals) has changed the test for admission of expert evidence in United States Federal Courts.1 Before that judgment was published, the test for the admission of expert evidence was much the same as that in Australia. In the case Frye v United States the test enunciated was that expert testimony was admissible if it was "deduced from a well recognised scientific principle or discovery, the thing from which the deduction is made [being] sufficiently established to have gained general acceptance in the particular field to which it belonged".23 Some commentators have expressed the view that there is a relatively close resemblance between the Frye test and the principles of admissibility employed in Australia.24,25 But there are contrary views as well.26,27 The decision in Daubert addressed the issue whether a small group of "impressively credentialled" scientists and doctors could present evidence which seemed to be scientific, but was of too recent origin to have been generally accepted.24 The majority judgment established two criteria for the admissibility of expert evidence: relevance and reliability. It was thus for the judge to ensure that all scientific testimony in evidence "is not only relevant, but reliable" (Daubert at 2795).1 The judges suggested four indicators for assessing whether the testimony met the test of reliability. These were whether the assertion can be and has been tested (i.e., whether it was capable, in Popper's terms, of falsification); whether the theory or technique has been subjected to peer review and publication; the known or potential rate of error; and whether there has been "general acceptance" within a relevant scientific community.24 The effect of Daubert is to impose upon the judge the task of assessing the reliability of a scientific opinion. If the Daubert test is accepted in Australia, the change may be described as transforming "the criteria for admissibility of scientific knowledge claimed, from one based on an expert community's 'general acceptance' of a particular theory to a focus upon the internal practices of the various sciences in combination with certain professional checks and balances such as peer review and error rate in conjunction with consideration of 'general acceptance'".24 It has been said that the shift in legal practice in the United States has transformed the role of the judge "from relatively passive assessor to an active inquisitor searching for the underlying essence of scientific knowledge claims".24 Regarding this, my question is whether this responsibility can be discharged by a judge working within the constraints of the adversarial system. I would think that there may be cases in which the judge, in order to evaluate the scientific evidence, would need to seek the assistance of interim instruction, as I might call it, to provide some basis of knowledge from which to understand the further processes which had produced the opinion offered. Assume, for example, that a judge must examine the reliability of an opinion about the cause of some cardiac condition. It is likely that the judge would need some instruction in basic medical theory and practice in order to understand the process of experiment, observation, and reasoning which has led to the theory from which the final opinion has been deduced. If a judge is confined to the evidence which the parties place before him or her, this process of instruction will be extremely difficult to manage. On the other hand, if every trial in which expert evidence is to be adduced involves subjecting the judge to a crash course of physiological, pathological or anatomical instruction, the trial will be infinitely prolonged and judges very rapidly exhausted. Questions of expert evidence and the difference between the scientific and the legal approach are, I think, both fascinating and critical in the administration of justice. The problem of how a judge is to choose between two scientific witnesses, each of whom appears to be thoroughly well qualified but who cannot agree upon a single particular, is one of perennial difficulty. The attempt to solve it by the device of relying upon the witness's demeanour, although championed by the High Court,28,29 is, in my respectful view, greatly open to question. But the growing incidence of novel medical and other scientific theories -- in particular, the challenge offered by syndrome evidence, leading to what has been called "forensic abuse syndrome"30 -- requires novel modes of judicial response. References Daubert v Merrell Dow Pharmaceuticals 113 Sct 2786 (1993). Miller Steamship Co Pty Ltd v Overseas Tankships (UK) Ltd. (1963) NSWR 737 at 753 per Walsh J. Burgess v Brownlow (1964) NSWR 1275 at 1277 per Manning J. Davie v Edinburgh Magistrates (1953) SC 34 at 40 per Lord President Cooper. Clark v Ryan (1961) 103 CLR 486 at 491-2 per Dixon CJ, at 501 per Menzies J and at 508 per Windeyer J. Wigmore on Evidence, Vol VII, s 1923. 3rd ed. Boston: Little, Brown & Company, 1940. Commissioner for Government Transport v Adamcik (1961) 106 CLR 292. Devlin P. The Judge. Oxford: Oxford University Press, 1981: 54. Whitehouse v The Queen (1983) 152 CLR 657. The Queen v Apostilides (1984) 154 CLR 563 at 571. Re Enoch & Zaretsky, Bock & Co's Arbitration (1910) 1 KB 327. Bassett v Host (1982) 1 NSWLR 206 at 207, 213. Obacelo Pty Ltd v Toveraft Pty Ltd (1986) 66 ALR 371. Cross on Evidence (Aust ed.) Vol 1 at 17080 et seq . Sydney: Butterworths, 1991. Popper K. Unended quest. Glasgow: Fontana-Collins, 1976: 151. Samuels G. Is this the best we can do? Aust J Forensic Sci 1993; 25: 3. Report of the Commission of Inquiry into Chamberlain Convictions, May 1987 (the Morling Report), especially at 324. Canberra: AGPS, 1987. Makler I. The Court of Appeal meets its Waterloo. Legal Service Bull 1991; 16(3): 107. Woffinden B. Miscarriages of justice. Sevenoaks: Coronet, 1989: 392. Report of the Royal Commission of Inquiry into the conviction of Alexander Lindsay, July 1991 (the Loveday Report), at 185. Bell D. Aust J Forensic Sci 1994; 26: 74 and 83. Bourke J. Misapplied science -- unreliability in scientific test evidence. Aust Bar Rev 1993; 10: 124. Frye v United States 293 F 1013 (1923) at 1014. Edmond G, Mercer D. Keeping "junk" history, philosophy and sociology of science out of the courtroom. U N S W Law J 1997; 20: 48-59. Arson M, Hunter J. Litigation: evidence and procedure. 5th ed. Sydney: Butterworths, 1995: 965. Freckelton J. The trial of the expert. Oxford: Oxford University Press, 1987: 60. Odgers S, Richardson J. Keeping bad science out of the courtroom: changes in American and Australian expert evidence law. U N S W Law J 1995; 18: 108, at 123. Abalos v Australian Postal Commission (1990) 171 CLR 167. Devries & Anor v Australian National Railways Commission & Anor (1993) 177 CLR 472, especially at 479. Freckelton I. Contemporary comment: when plight makes right -- the forensic abuse syndrome. Crim Law J 1994; 18: 29. Originally delivered as the 1997 AMA (NSW) Oration in the Great Hall of the University of Sydney, Tuesday, 17 June 1997. Authors' details Office of the Governor, Macquarie Street, Sydney, NSW. Gordon Samuels, AC, Governor of New South Wales. Correspondence: The Honourable Gordon Samuels, Governor of New South Wales, Macquarie Street, Sydney, NSW 2000. - Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Gordon Samuels

Cloning: potential benefits for human medicine Of babies, lambs, medicine and milk MJA 1997; 167: 568-569 Recent developments in cloning of animal cells (such as the creation of the lamb "Dolly")1,2 and the consequent ban by President Clinton on cloning humans in the United States3 have stimulated much discussion of the merits and ethics of cloning. Indeed, a number of countries (e.g., Germany and Denmark) and Australian States (e.g., Victoria) ban all forms of cloning in human reproductive medicine by legislation or regulation. The most publicised advance in cloning attended the birth of Dolly, a lamb created from a ewe's mammary cell.2 This achievement showed that completely differentiated cells (both fetal and adult) may be reprogrammed to return to multipotential embryonic cells. This is done by inducing a quiescent state (G 0 phase of the cell cycle) in the somatic cell and then fusing it with the enucleated cytoplasm of a mature egg (Figure 1). The fused product then acts as an embryo and develops according to a preset maternal program rather than as the original somatic cell. At present, the procedure is relatively inefficient and confined to ruminant species (sheep and cattle).1,2,4,5 It is unsuccessful in rodents,6,7 which have been the model for understanding mammalian cell differentiation and tissue formation. It is not known if humans fit the ruminant or rodent model, although the recent births of rhesus monkeys derived from embryonic cells (Dr D Wolf, Senior Research Scientist, Oregon Regional Primate Research Center, Beaverton, Oregon, US, personal communication) suggest the former. This finding has major implications for medicine and agriculture, as it opens the way to use differentiated somatic cells as vectors for genetic engineering to produce transgenic animals and for gene therapy. Considerable research on developing such vectors has focused on embryonic stem (ES) cells. Rodent ES cells have been widely used for determining gene function, as they can be manipulated to "knock out" or upregulate genes or to introduce foreign genes.8 ES cells combined with early embryos contribute to all body tissues during development, including gonadal germ cells. When bred, the resulting animals transmit the ES cell genotype, allowing the effects of the gene manipulations to be analysed. It would be even more efficient to genetically manipulate somatic cells of sheep or cattle in culture and to use these cells for cloning 2 (Figure 2). Offspring would probably always have the desired transgene. This could code for a human protein used to treat or prevent disease (such as factor VIII and interferon), and large quantities of the protein could be produced in the animal's milk under the control of specific promoters. As proteins can be isolated from milk relatively simply, this might be an extremely cheap and efficient way to produce large quantities of human or animal pharmaceuticals. It might also be very competitive with present methods of producing recombinant proteins (e.g., from bacterial, yeast and mammalian cell lines). When one considers the cost and problems of producing antiviral drugs as well as proteins for immunisation and therapy (e.g., for haemophilia, HIV infection and multiple sclerosis), the potential for pharmaceutical production in cattle becomes economically attractive. Australia has a unique position for developing this biotechnology as our sheep and cattle are relatively disease-free. What might be other benefits of the recent advances? The search for human multipotential cells as vectors for gene therapy and as universal transplantation cells for correcting abnormal tissue function or tissue damage in humans has also focused on ES cells. 9 These have been derived from the embryonic inner cell mass,10 undifferentiated gonadal cells (GS cells),11 and stem cells which form specific tissues.12 Progress on producing these cells has been limited, although a rhesus monkey ES cell line was recently produced.13 However, ES cells may still be recognised as foreign and be rejected by the recipient. Cloning a patient's somatic cells could be a way of producing multipotential cells that are genetically identical to those of the patient and therefore not subject to rejection (Figure 3). These cells might be ideal vectors for gene therapy, but would also need to be clonally stable and to produce the cell type needed for transplantation, which requires considerable further research. These potential benefits of cloning are often ignored in the debate about its use for human reproduction. Yet, cloning could not reproduce an individual with the same attitudes, beliefs and behaviour as the original person because of the predominant influence of non-genetic factors in human development.14 While no real objection is raised to identical twins produced by natural conception, or even as a result of in-vitro fertilisation, cloning of individuals from somatic cells has no biological or social merit and in this context is unethical. However, we should not lose the substantial benefits of other applications of cloning technology in the regulatory and legislative processes, and moratoriums should not impede progress to achieve these benefits. Alan O Trounson Professor, Institute of Reproduction and Development, Monash University Monash Medical Centre, Melbourne, Victoria Campbell NHS, McWhir J, Richie WA, et al. Sheep cloned by nuclear transfer from a cultured cell line. Nature 1996; 380: 64-66. Wilmut I, Schnieke AE, McWhir J, et al. Viable offspring derived from fetal and adult mammalian cells. Nature 1997; 385: 810-813. Gorman C. To ban or not to ban? Time 1997; June 16: 66. Willadsen SM. Nuclear transplantation in sheep embryos. Nature 1986; 320: 63-65. Tatham BG, Dowsing AT, Trounson AO. Enucleation by centrifugation of in vitro matured bovine oocytes for use in nuclear transfer. Biol Reprod 1995; 53: 1088-1094. Surani MAH, Barton SC, Norris ML. Experimental reconstruction of mouse eggs and embryos: an analysis of mammalian development. Biol Reprod 1987; 36: 1-16. McGrath J, Solter D. Nuclear transplantation in the mouse by microsurgery and cell fusion. Science 1983; 220: 1300-1302. Joyner A. Gene targeting and gene trap screens using embryonic stem cells: new approaches to mammalian development. Bioessays 1991; 13: 649-656. Trounson A. Research on the development of human embryonic stem cells. Sing J Obstet Gynaecol 1994; 25: 245. Pedersen RA. Studies on in vitro differentiation with embryonic stem cells. Reprod Fertil Develop 1994; 6: 543-552. Travis J. Human embryonic stem cells found? Science News 1997; 152: 36. PrŸmmer O, Fliedner TM. The fetal liver as an alternative stem cell source for hemolymphopoietic reconstitution. Int J Cell Cloning 1986; 4: 237-249. Thompson JA, Kalishman J, Golos TG, et al. Isolation of a primate embryonic stem cell line. Proc Natl Acad Sci USA 1995; 92: 7844-7848. Machin GA. Some causes of genotypic and phenotypic discordance in monozygotic twin pairs. Am J Med Genet 1996; 61: 216-228. Reprints: Professor A O Trounson, Institute of Reproduction and Development, Level 5, 246 Clayton Road, Clayton, VIC 3168. - ©MJA 1997 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Alan O Trounson

Mifepristone (RU486) and abortion A safe, effective and acceptable alternative to surgery MJA 1997; 167: 292-293 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 There is overwhelming evidence that the provision of safe and accessible induced abortion is a major factor in preserving the reproductive health of women, but 24% of the world's population live in countries where abortion is not legally permitted. Abortion in these countries can involve spells and incantations, ingestion of herbs or manipulations, such as introducing sticks or disinfectants into the uterine cavity. Such methods vary from being harmless, but ineffectual, to highly lethal, and it is not surprising that 99% of maternal deaths from abortion occur in countries where the more dangerous of these practices are common.1 In Australia, where abortion is widely available and publicly funded, service providers have a duty to ensure that, as with any other legally available medical procedure, the methods used are safe, effective and acceptable. It has been estimated one in three Australian women will seek an induced abortion during their reproductive lifetime. Abortion can be achieved either surgically or medically. Surgical procedures include uterine evacuation via the vagina, and vacuum aspiration is now used to perform over 98% of all first-trimester abortions,2 providing the benchmark against which newer techniques must be assessed. In countries where abortion is legal and supervised by a trained practitioner, vacuum aspiration is very safe and effective. Maternal death occurs in only one in 100000 cases, serious morbidity in less than 1% of cases, and minor morbidity (including psychological disturbances) in 10% of cases. Severe haemorrhage, infective complications and genital tract trauma account for 85% of all major complications. Minor morbidity most often includes prolonged uterine bleeding, retained products of conception, or uterovaginal infection.2,3 It has been estimated that at current rates of abortion one in three Australian women will seek an induced abortion during their reproductive lifetime.4 As 70% of all women who undergo abortion intend to have children in the future, even a small increase in the risk of adverse future reproductive outcomes would have a major impact. Well-controlled, prospective cohort studies suggest that there is no increased risk of complications (including miscarriage and preterm delivery) during future pregnancies after a single abortion by vacuum aspiration, but there are fewer data on multiple vacuum aspiration abortions.5 In 1978 the World Health Organization recommended research into the "development of a non-surgical method of abortion, non-toxic to the woman and non-teratogenic in an effective dosage, reliably producing complete expulsion of the products of conception, suitable for application in a non-clinical setting and economically accessible to women in all countries". Methods of medical induction of abortion include prostaglandins used alone (such as misoprostol, which is available on the Australian Schedule of Pharmaceutical Benefits for other indications, and widely used in other countries for inducing abortion) and, more recently, the antiprogesterones.6 Progesterone is vital for the support of the developing embryo, and the antagonism of this hormone has been tested clinically by inhibiting its production and by direct blockade of progesterone receptors. Drugs such as epostane and trilostane act indirectly by inhibiting the conversion of the precursor, pregnenolone, into progesterone. However, these drugs have been overshadowed by the development of mifepristone, which blocks the action of progesterone at the receptor level. Used alone, mifepristone is not an effective abortifacient, but it becomes one when combined with prostaglandin analogues. Mifepristone (200 mg, orally) used with misoprostol (400 mg, orally or vaginally) results in complete abortion (complete expulsion without the need for subsequent surgical uterine evacuation) at rates of over 95%, with 98% of all women able to leave hospital within eight hours of prostaglandin administration. Efficacy declines as gestational age increases, so this method is usually restricted to gestations of less than nine weeks. The process of care and frequency of unpleasant side effects associated with any procedure will affect its acceptability and hence uptake by the community as a whole. The main short term sequelae of medical abortion include pelvic pain, vaginal bleeding and gastrointestinal disturbance, but these are short lived, and most women return to normal daily activity after 24 hours.7 Women are not anaesthetised in any way during medical abortion, but around 50% require analgesia, and the products of conception may be visualised. Despite these apparent drawbacks, the acceptability of medical abortion is high among European and Chinese women.8,9 Australian women, as reported by Mamers and colleagues in this issue of the Journal, also find the process acceptable.10 Women who sought medical abortion in the Australian arm of an international trial sponsored by the World Health Organization were satisfied with the method and most found the associated level of pain acceptable; those who had had previous surgical abortions also found the medical method more acceptable. Reasons given by Australian women for choosing medical abortion included avoidance of anaesthesia and increased autonomy, that medical abortion is more "natural" and emotionally acceptable, and that it is less stressful. Women also seem to have strong preferences for a particular method -- over 90% of the women interviewed in a British trial indicated that they would have been prepared to pay a premium to ensure that they had a choice of abortion method.11 Prospective randomised trials and cohort studies of vacuum aspiration and mifespristone/prostaglandin regimens have compared safety, efficacy, acceptability, psychological outcomes, economic outcomes and long term sequelae of these alternative methods. There seem to be few differences between the alternatives in any of the parameters studied, and indeed medical abortion may be the procedure of choice at very early (less than seven weeks) gestations. In some United Kingdom hospitals, 60% of abortions are now performed medically, and worldwide over one million women have used the regimen.12-14 Mifepristone has other clinical uses. It has been used to shorten the process and reduce analgesia requirements in labour induction in cases of second-trimester and third-trimester abnormal pregnancy or intrauterine fetal death. Medical uterine evacuation in first-trimester miscarriage is also being explored.15 Critics of mifepristone claim that it will make abortion "easier". The meaning of "easier" is often not defined, but could include easier access to safe abortion services, an easier treatment for medical and nursing staff to administer, or easier -- both physically and psychologically -- for the women having abortions. Some claim that this will lead to an overall increase in the frequency of abortion, although there is no evidence to support this assumption. It is clear, however, that mifepristone/prostaglandin regimens offer safe, effective and acceptable alternatives to surgery that will tend to reduce maternal mortality and morbidity in both developed and, more especially, developing nations. Richard C Henshaw Obstetrician and Gynaecologist Queen Elizabeth Hospital, Woodville, SA Mahler H. The safe motherhood initiative: a call to action. Lancet 1987; 1: 668-670. Henshaw RC, Templeton AA. Methods used in first trimester abortion. Curr Obstet Gynaecol 1993; 3: 11-16. Grimes DA, Cates W. Complications from legally induced abortion: a review. Obstet Gynaecol Surv 1979; 34: 177-191. An information paper on termination of pregnancy in Australia. Canberra: National Health and Medical Research Council, 1997. Hogue CJR, Cates W, Tietze C. The effects of induced abortion on subsequent reproduction. Epidemiol Rev 1982; 4: 66-94. Misoprostol and legal medical abortion [editorial]. Lancet 1991; 338: 1241-1242. Henshaw RC, Naji SA, Russell IT, Templeton AA. A comparison of medical abortion (using mifepristone and gemeprost) with surgical vacuum aspiration: efficacy and early medical sequelae. Hum Reprod 1994; 9: 2167-2172. Bachelot A, Cludy L, Spira A. Conditions for choosing between drug induced and surgical abortions. Contraception 1992; 45: 547-549. Tang GW, Lau OW. Further acceptability evaluation of RU486 and ONO 802 as abortifacient agents in a Chinese population. Contraception 1993; 48: 267-276. Mamers PM, Lavelle AL, Evans AJ, et al. Women's satisfaction with medical abortion with RU486. Med J Aust 1997; 167: 316-317. Howie FL, Henshaw RC, Naji SA, Russell IT, Templeton AA. Medical abortion or vacuum aspiration? Two year follow up of a patient preference trial. Br J Obstet Gynaecol 1997; 104: 829-833. Kaunitz AM, Rovira EZ, Grimes DA, Schulz KF. Abortions that fail. Obstet Gynecol 1985; 66: 533-537. Ulmann A, Silvestre L, Chemama L, et al. Medical abortion of early pregnancy with mifepristone (RU486) followed by a prostaglandin analogue. Acta Obstet Gynecol Scand 1992; 71: 278-283. Bird DT. Medical abortion in Britain. Br J Obstet Gynaecol 1994; 101: 367-368. Rodger MW, Baird DT. Pre-treatment with mifepristone (RU486) reduces interval between prostaglandin administration and expulsion in second trimester abortion. Br J Obstet Gynaecol 1990; 97: 41-46. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Richard C Henshaw

Women's satisfaction with medical abortion with RU486 Pam M Mamers, Anna L Lavelle, Amanda J Evans, Sandra M Bell, Jen R Rusden and David L Healy The combination of RU486 (mifepristone) and prostaglandin analogues has been used for medical abortion in several European centres. We surveyed 41 Australian women who successfully used this method of abortion in a World Health Organization-sponsored trial. Overall, the women were satisfied with the method and found the associated pain level acceptable. (MJA 1997; 167: 316-317) For editorial comment, see Henshaw Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Introduction - Clinical record - Results - Discussion - Acknowledgements - References - Authors' details - - ©MJA1997 Introduction A safe, reliable, non-invasive, but effective, method of fertility control has been sought for many years. The combination of the progesterone antagonist mifepristone (RU486) and prostaglandin E1 analogues has been used in several European countries for medical abortion, and its efficacy has been extensively studied for human fertility control. RU486 has been approved for use in the United Kingdom, Sweden, China and France, and it is estimated that over a million women have received RU486 in these countries since 1988 (Dr P Van Look, Associate Director, Special Program of Research, Development and Research Training, World Health Organization, personal communication). Following approval from the Therapeutic Goods Administration in March 1994, the World Health Organization selected Monash University and Family Planning Victoria to participate in an international multicentre, double-blind, randomised controlled trial to test the efficacy and side effects of two doses of mifepristone (600 mg or 200 mg) followed by 400 mg of misoprostol 48 hours later for the termination of early pregnancy. Ethical approval to conduct the trial was obtained from the ethics committee of Family Planning Victoria. We thought it would be useful to know if the Australian women who participated in this WHO trial considered medical abortion an acceptable primary treatment and if their level of pain was acceptable. For women who had had a previous surgical termination, we were interested in how they felt the methods compared. Clinical record Fifty patients seeking legal abortion were admitted to the study on satisfying the criteria of the WHO protocol, which were: women seeking legal abortion, in good general health, over the age of consent, with a menstrual delay of up 35 days, with uterine size equal to that expected for the estimated duration of pregnancy, having had a positive pregnancy test, and who gave informed consent. Each woman received extensive counselling by the nurse coordinator (P M M) and the investigator (D L H) before entering the trial. Women were advised that further counselling would be available at any time. According to the trial protocol, participants attended the clinic to receive mifepristone and returned after 48 hours to receive misoprostol. Women were offered paracetamol (500 mg) for mild to moderate pain or pethidine (50 mg intramuscularly) for severe pain. Analgesic preparations known to interfere with prostaglandin metabolism, such as salicylates and mefenamic acid, were not dispensed and women were advised not to take these. Patients returned for follow-up two weeks and six weeks after abortion. Five women were withdrawn from the trial because they needed surgical intervention. Four women who had a successful termination of pregnancy failed to attend for assessment at six weeks and were lost to follow-up. Thirty-eight of the remaining 41 women who completed the protocol agreed to complete a self-administered questionnaire to assess their satisfaction with medical abortion. The questionnaire included two visual analogue scales on which: All women were asked to score their degree of satisfaction with the medical abortion (Box 1a); and Women who had previously had a surgical abortion were asked to compare medical abortion with the surgical procedure (Box 1b). Further, the questionnaire included questions about cost, avoidance of anaesthesia, whether the procedure was considered more natural, and whether the pain and discomfort were acceptable. Women were also invited to make personal comments about why they chose a medical abortion and how they rated their experience. Results The demographic variables for the 38 women who completed the questionnaire are shown in Box 2. The mean score for satisfaction with medical termination of pregnancy was 4.5 (range, 1-5). The 15 women who had previously had a surgical abortion found the medical approach more acceptable (mean score, 4.5; range, 3-5). The level of pain and discomfort was regarded as acceptable by 34 participants; 19 women experienced only mild discomfort, while one woman was pain free. Seventeen of these 20 women did not require analgesia. Only one patient required pethidine for severe pelvic cramping. The remaining women who required analgesia were satisfied with paracetamol. Cost was an important factor in the choice for seven of the 38 participants. There were no costs involved for trial patients. As public hospitals in Victoria are able to service only a small number of patients, most women seeking termination must attend private abortion clinics, so that cost becomes a factor in their choice of provider. The wish to avoid anaesthesia was important for 19 women, while 25 regarded medical abortion as more natural. Other factors in women's decisions to choose medical termination included preferring a less clinical atmosphere and finding research staff to be very supportive at a stressful time (nine women), considering a medical termination to be more emotionally acceptable (nine women), and fear of surgical operation (six women). Other factors included more autonomy (expressed as "a need to be in control of the situation") and the desire for a less invasive procedure. One woman stated: "I was much more able to cope with my decision to have a medical termination as I was conscious the whole time and did not feel that my body was invaded." Six women reported that the associated pain and the duration of bleeding was a drawback for medical abortion, but all six rated the procedure as acceptable. Discussion We acknowledge that our sample was biased, as the 38 women who completed questionnaires sought out medical termination of pregnancy. However, in terms of many demographic variables, our participants were similar to a large sample of women who sought surgical terminations in New South Wales surveyed by Adelson et al.1 Over half the women in both groups were single, most were 25 years or under and they were generally well educated. Satisfaction with medical termination of pregnancy among the 38 women was evident. The factors involved in their choice of medical abortion were complex. Overall, medical abortion provided women with a more active role in the process, thus allowing them to achieve a certain degree of autonomy. Most of the women surveyed described the medical approach as more natural, and two women likened the procedure to having a miscarriage. The requirements for a medical abortion differ in many respects from those for a surgical abortion. In particular, partners, friends or family could be present at any time, and patients were not required to fast during the three hours they remained in the clinic after being given misoprostol. Many of the women who participated in the trial commented on the friendly, non-clinical approach, which they considered psychologically beneficial at a time when anxiety levels were increased. Similar psychological benefits of medical abortion have been noted by Henshaw and colleagues.2 Medical abortion as an alterative to surgical abortion has gained acceptance in countries in which it has become available. In a British study of 363 women undergoing first-trimester abortion, 20% of women chose medical abortion, 26% chose the surgical technique, and the remainder agreed to be randomised to either method.3 This finding concurs with earlier studies in France where one-fifth of women chose medical abortion.4 In a Chinese study, women who were likely to accept medical abortion were single, young, nulliparous and employed; these women were reportedly fearful of "trauma to the body" from surgical abortion.5 Significantly, all women who answered the questionnaire in that study said that they would choose medical termination again.5 As Baird6 has suggested, more studies are needed to establish the acceptability of mifepristone (RU486) for termination of pregnancy in different countries and different cultures. A further follow-up study in Australia with a larger sample of women would be useful in this regard. Acknowledgements We thank our patients as well as Family Planning Victoria for their support and recruitment of women for this study. References Adelson PL, Frommer MS, Weisberg E. A survey of women seeking termination of pregnancy in New South Wales. Med J Aust 1995; 163: 419-422. Henshaw RC, Naji SA, Russell IT, Templeton AA. Psychological responses following medical abortion (using mifepristone and gemeprost) and surgical vacuum aspiration. Acta Obstet Gynecol Scand 1994; 73: 812-818. Henshaw RC, Naji SA, Russel IT, Templeton AA. Comparison of medical abortion with surgical vacuum aspiration: women's preferences and acceptability of treatment. BMJ 1993; 307: 714-717. Bachelot A, Cludy L, Spira A. Conditions for choosing between drug-induced and surgical abortions. Contraception 1992; 45: 547-559. Tang GW, Lau OW. Further acceptability evaluation of RU486 and ONO 802 as abortifacient agents in a Chinese population. Contraception 1993; 48: 267-276. Baird DT. Clinical use of mifepristone (RU486). Ann Med 1993; 25: 65-69. (Received 17 Dec 1996, accepted 27 Jun, 1997) Authors' details Monash University Department of Obstetrics and Gynaecology, Monash Medical Centre, Melbourne, VIC. Pam M Mamers, RN, BA, Clinical Research Nurse; Amanda J Evans, FRACGP, CertFPA, Medical Director Family Planning, and Honorary Senior Lecturer; David L Healy, FRACOG, PhD, Chairman. Family Planning Victoria, Melbourne, VIC. Anna L Lavelle, BSc(Hons), PhD, Executive Director; Sandra M Bell, RN, RM, Research Nurse and Pregnancy Counsellor; Jen R Rusden, RN, Research Nurse and Pregnancy Counsellor. Reprints will not be available from the authors. Correspondence: Ms P M Mamers, Monash University Department of Obstetrics and Gynaecology, Level 5, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Pam M Mamers · Anna L Lavelle · Amanda J Evans · Sandra M Bell · Jen R Rusden · David L Healy

Deaths, dying and the euthanasia debate in Australia The findings of a study of end-of-life medical decisions in Australia may provide ammunition for both supporters and opponents of euthanasia MJA 1997; 166: 173 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - - ©MJA1997 General trends have emerged: there is majority community support for euthanasia or physician-assisted suicide The debate on euthanasia in Australia shifted abruptly from abstraction to reality with the passage of the Rights of the Terminally Ill Act by the Northern Territory Parliament in May 1995. Overnight, euthanasia and physician-assisted suicide became a legal choice for people with terminal illness.1 The Act has focused and polarised opinions on issues relating to medical decisions at the end of life. The deaths of three Australians (to date) under the provisions of the Act have been accompanied by an outburst of variously composed Greek choruses: citizens, ethicists, doctors, politicians, and media commentators. What should have been dignified and private affairs have been transformed into public events. The intent and provisions of the Act are supported by, among others, the Doctors' Reform Society, the Euthanasia Society, and the AIDS Council of New South Wales. They are opposed by the Australian Medical Association (AMA),2 the Australian Association for Hospice and Palliative Care,3 mainstream religions, Right To Life Australia, and organisations representing the aged and those with disabilities. The Act has been challenged in the High Court of Australia by Dr Chris Wake, the President of the Northern Territory Branch of the AMA, and Dr Djiniyinni Gondarra, an Aboriginal minister of the Uniting Church, who sought special leave to appeal the decision of the Northern Territory Supreme Court upholding the validity of the Northern Territory euthanasia law. The High Court has adjourned the hearing of this application,4 pending the outcome of the Euthanasia Laws Bill introduced in the Federal Parliament of Australia by Mr Kevin Andrews, a Member of the House of Representatives. The intention of the Bill is to deny the Northern Territory legislative power over euthanasia, and to render Northern Territory law null and void. It has passed through the Lower House, and the Australian Senate has referred the Euthanasia Laws Bill to its Legal and Constitutional Legislation Committee, which reports to the Senate in late February this year. Despite the strong arguments advanced by both sides of the debate, a critical component absent from the assertions are actual data on end-of-life medical decisions. Most Australian surveys have used hypothetical models.5-9 The limitations of these studies include notional concepts; inconsistent definitions of euthanasia and other medical decisions at the end of life; lack of information about non-responders to surveys; and lack of validation. Doubts have also been expressed about the representativeness of the cohorts sampled. Despite these qualifications, general trends have emerged: there is majority community support for euthanasia or physician-assisted suicide9,10 and for legislation to allow these practices.9 However, the converse is true for the majority of the medical profession.8,9 Despite this medical disapproval, there is evidence that euthanasia and physician-assisted suicide are practised by some Australian doctors.5-7 Similar findings have been reported in the United Kingdom.11 However, these surveys give no quantitative indication of the extent of these practices in Australia. In this issue of the Journal, Kuhse and her colleagues report such data, obtained by an adaptation of the methods used to determine these practices in the Netherlands.12,13 In the Netherlands, euthanasia and physician-assisted suicide have been accepted for over 20 years. While these practices are illegal, and punishable by imprisonment -- 12 years for euthanasia and 3 years for physician-assisted suicide -- they are condoned by strong public support and have a legal basis in the force majeure, whereby the doctor must act.14 Dutch doctors can be reasonably sure that they will not be prosecuted if they follow the guidelines for the practice of euthanasia issued in 1984 by the Royal Dutch Medical Association and endorsed by the Dutch Government.14 End-of-life medical decisions in the Netherlands have been scrutinised by two government-initiated surveys, one in 1990,12 and the other in 1995.13 The latter survey conducted two separate studies: one based on interviews of a stratified sample of doctors, and the other on responses to questionnaires mailed to physicians identified on death certificates of about 6000 deaths (in the Netherlands, for all deaths the cause must be reported on a uniform death certificate, forwarded to a central authority -- Statistics Netherlands). In the study of Kuhse et al. an English version of the Dutch questionnaire was forwarded to 3000 Australian doctors, stratified to mimic the broad categories of doctors in the Dutch study. The categories and definitions of end-of-life medical decisions in both studies were identical. A broad overview of the outcomes of the Australian and Dutch studies is of interest. Kuhse et al. report that end-of-life medical decisions were made in approximately 65% of deaths in Australia (corresponding Dutch 1995 estimate, 42%). The estimated Australian incidences for specific end-of-life medical decisions in 1995 were: euthanasia, 1.7% (corresponding Dutch 1995 estimate, 2.4%); physician-assisted suicide, 0.1% (0.2%); ending of life without the patient's explicit request, 3.5% (0.7%); alleviation of pain and symptoms with opioids, with probable life-shortening effects, 30.9% (19.1%); and decisions to forgo treatment, 28.6% (20.2%). The estimated time (days) by which life was shortened by end-of-life medical decisions was comparable in the two studies. How does the Australian and Dutch experience compare with that in other developed industrialised countries? In the United States, euthanasia and physician-assisted suicide are illegal. However, the US Supreme Court will decide later this year whether to uphold the decisions of two US Courts of Appeals to permit doctors to help terminally ill patients commit suicide.15 In a recent survey of physicians in the State of Washington,16 12% said that they had been asked in the last 12 months to assist suicide and 4% had been asked to perform euthanasia; physicians had complied with a quarter of the euthanasia requests, giving a percentage for euthanasia comparable with that found by Kuhse et al. in Australia. The American Hospital Association has estimated that about 70% of US hospital deaths occur after decisions to forgo treatment,17 but there are no readily retrievable US data on how often the use of opioids for symptom relief in terminally ill patients has hastened death. Will the report by Kuhse et al. influence the anti- and pro-euthanasia positions in Australia? Considering the intransigent attitudes of both groups, this seems unlikely. Those who support euthanasia will argue that the findings of Kuhse et al. of the practice of both euthanasia and physician-assisted suicide, and their large estimate for the number of patients for whom end-of-life medical decisions were made without an explicit patient request (albeit more than 50% were mentally not competent), warrant the development of guidelines, and independent audits to assure compliance. Legislation for euthanasia is the best way to ensure this. Moreover, removal of a legal threat by decriminalisation will also remove the need for anonymity and allow an open review of practices. Proponents will further argue that the longitudinal data from the 1990 and 1995 Dutch studies indicate that fears about the "slippery slope" (such as voluntary euthanasia leading to non-voluntary euthanasia) are not justified. For the proponents of euthanasia the Australian estimates for end-of-life medical decisions, other than for euthanasia and physician-assisted suicide, will represent experiences in which patients are presumed to have endured pain and suffering, and which, out of respect for autonomy and compassion, they should be able to relieve by choosing euthanasia. For many supporters of euthanasia and physician-assisted suicide, the distinction between euthanasia and refusal of treatment, or the use of palliative treatments that may hasten death, is logically, philosophically and morally ambiguous. These "moral-equivalence" arguments have been challenged (see Ashby, this issue of Journal). For opponents of euthanasia the findings of Kuhse et al. will be seen as potent reasons for enhancing access to, and quality of, palliative-hospice care and mental health services in Australia. For many, the findings of both the Australian and Dutch studies will not extinguish fears of the "slippery slope", at the end of which are loss of the sanctity of life, a broadening of the criteria for euthanasia, and a change in the values of society and the ethos of medicine. For others, the study findings will highlight the complexities of clinical decisions and circumstances, which, in themselves, have been neglected in the euthanasia debate in the medical, legal and ethical arenas; the law and ethics cannot operate in a vacuum. The opponents of euthanasia will argue that, although they respect patient autonomy, this cannot be divorced from the intricacies of the patient-doctor relationship, or, for that matter, the patient-family and other important relationships. Finally, despite the findings of Kuhse et al., opponents of euthanasia legislation will argue that the law lacks the sensitivity and compassion required to deal with such a complex event as dying, and that intrusion of the law into this area will have unforeseen consequences. For the neutralists in the euthanasia debate, the findings of Kuhse et al. will emphasise how little is known about how and where people die in Australia. They will say the results underscore the inadequacies of training programs for the care of the dying, and draw attention to the complexities and vicissitudes of the communications between patients and doctors. Finally, they will call for programs that both explore the issues of death and dying, and ensure that the circumstances of this inevitable event are compassionate and humane. Martin B Van Der Weyden Editor, The Medical Journal of Australia Sydney, NSW Ryan CJ, Kaye M. Euthanasia in Australia -- the Northern Territory Rights of the Terminally Ill Act. N Engl J Med 1996; 334: 326-328. Australian Medical Association Position Statement on Care of Severely and Terminally Ill Patients. Canberra: AMA, May 1996. Australian Association for Hospice and Palliative Care. Voluntary active euthanasia -- position statement. Perth: AAHPC, October 1995. High Court defers to MPs on euthanasia. The Weekend Australian 1996; Nov 16: 9. Kuhse H, Singer P. Doctors' practices and attitudes regarding voluntary euthanasia. Med J Aust 1988; 148: 623-627. Baume P, O'Malley E. Euthanasia: attitudes and practices of medical practitioners. Med J Aust 1994; 161: 137-144. Stevens CA, Hassan R. Management of death dying and euthanasia: attitudes and practices of medical practitioners in South Australia. J Med Ethics 1994; 20: 41-46. Waddell C, Clarnette RM, Smith M, et al. Treatment decision-making at the end of life: a survey of Australian doctors' attitudes towards patients' wishes and euthanasia. Med J Aust 1996; 165: 540-544. Steinberg MA, Najman JM, Cartwright CM, et al. End-of-life decision making: community and medical practitioners' perspectives. Med J Aust 1997; 166: 131-135. Vote life death choice. The Bulletin 1996; Sep 17: 18-22. Ward BJ, Tate PA. Attitudes among NHS doctors to requests for euthanasia. BMJ 1994; 308: 1332-1334. van der Maas PJ, Van Delden JJM, Pijnenborg L, Looman CWN. Euthanasia and other medical decisions concerning the end of life. Lancet 1991; 338: 669-674. van der Maas PJ, van der Wal G, Haverkate I, et al. Euthanasia, physician-assisted suicide, and other practices involving the end of life in the Netherlands, 1990-1995. N Engl J Med 1996; 335: 1699-1705. van der Wal G, Dillmann RJM. Euthanasia in the Netherlands. BMJ 1994; 308: 1346-1349. Angell M. The Supreme Court and physician-assisted suicide -- the ultimate right. N Engl J Med 1997; 336: 50-53. Back AL, Wallace JI, Starks HE, Pearlman RA. Physician assisted suicide and euthanasia in Washington state: patients requests and physicians responses. JAMA 1996; 275: 919-925. Brief of the American Hospital Association as amicus curiae in support of petitioner Nancy Beth Cruzan, Lester L and Joyce Cruzan. Chicago: American Hospital Association, 1 September 1989. - - - To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

The fallacies of death causation in palliative care While the debate about euthanasia continues, society should focus more on palliative care which is clinically safe and ethically sound MJA 1997; 166: 176 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - - ©MJA1997 The most important thing is promoting the comfort, dignity and autonomy of people who are dying In studies which generated the first data on the incidence of euthanasia in the Netherlands,1-3 the practice was categorised as a type of "medical decision at the end of life", defined as: "all decisions by physicians concerning courses of action aimed at hastening the end of life of the patient or courses of action for which the physician takes into account the probability that the end of life of the patient is hastened." Two other categories which van der Maas and colleagues created were the administration of "high" doses of opiates that "almost certainly would shorten the life of the patient" and decisions in which "life-prolonging" treatment was withheld or withdrawn.4 In this issue of the Journal, Kuhse et al. report the results of their Australian study based on the approach taken by these studies. One line of argument advanced by those in favour of legalising euthanasia is to suggest that if doctors already cause (or hasten) death by stopping "active" treatment or by palliative interventions, such as the use of escalating morphine doses for pain control, they should not object to the administration of a lethal injection or the supply of the means to commit suicide at the explicit request of a terminally ill patient. By demonstrating a high incidence of so-called "medical decisions at the end of life" which are argued to cause death (approximately 65% of deaths in the study by Kuhse et al.), advocates of the legalisation of voluntary active euthanasia presumably hope to show that existing medical practice is inconsistent in both its principles and processes. There are two major false premises which need to be challenged. Firstly, it is a common belief, and the basis of a considerable body of legal and legislative opinion, that the dose of morphine (or other opioid) per se is the main determinant of whether the drug causes or hastens death.5 In fact, there is no such determinative dose. What matters is the relationship of a dose to the previous dose. In pain management gradual dose escalation by 50%-100% of the previous dose is usual practice, although substantially higher increases can usually be well tolerated by patients who are not new to the drug. It is therefore the size of the initial dose, and the rate of subsequent increases, which are important. Unlike most other forms of drug treatment, there are no predetermined dose ranges of morphine for achieving satisfactory control of cancer pain. Therefore, treatment has to be skilfully adjusted on an individual basis. For most adults a daily dose in the range 30-200 mg, orally, will achieve initial pain control. The accepted practice, used safely for at least 20 years, is to adjust the regular dose (usually) upwards according to the requirements to keep the pain under control, balanced against the occurrence of side effects. Many doctors still believe that they are causing or hastening the death of patients by this process, despite an extensive and sustained international campaign by the World Health Organization and a lack of any evidence to support this view. Like any drug, morphine is dangerous if used without clinical skill. Appropriate opioid use is surrounded by myths and fears among both the general public and health care professionals, appearing to be largely attributable to the history and non-medical use of this class of drugs.6 Secondly, surely nobody benefits from lines of argument which equate the cessation of treatment or decisions not to treat when a person is dying (even if treatment is potentially life-prolonging) with giving a lethal injection to end a life. "Moral-equivalence" arguments based on outcome cannot ignore the assessment of clinical proportionality and appropriateness. Although Keyserlingk has argued against overemphasis on "but-for" causality in this debate,7 the death is surely caused only if the treatment can be demonstrated to be clinically effective in the circumstances, and the underlying condition is potentially reversible (i.e., there is a disruption of a pre-existing chain of causation).8 For a competent patient who expresses a wish to reject any medical treatment whatsoever, this has been clearly accepted as morally and legally permissible, and the issue is not controversial. While van der Maas et al.9 and Kuhse et al. are right to draw attention to situations in which patients were not consulted about medical decisions, treatment abatement cannot be negotiated with incompetent dying people. Unfortunately, incompetence due to organic brain dysfunction is fairly common during the dying process and medical decisions do have to be taken.10 Although the Australian doctors in the report by Kuhse and colleagues may be reflecting a degree of honest pragmatism, this finding clearly needs more exploration -- with particular emphasis on the transparency of process, negotiation and consultation. Kuhse et al. state that death was the "partly or explicitly" intended outcome of a medical decision to end life in 36.5% of all Australian deaths. While they attempted to ascertain intention, neither their study nor the Dutch studies validate the doctors' responses by examining clinical data and prescription records. In the absence of formal training in palliative care -- a relatively recent advent in most medical schools -- doctors' attitudes and clinical behaviour are complex and variable. They range from abrupt cessation of treatment, minimalist palliative care and treatment directed at bringing about a rapid dying process, to excessive caution about being seen to be instrumental in causing the death, particularly with regard to providing pain and symptom relief, withdrawal or non-initiation of artificial hydration and alimentation, and cardiopulmonary resuscitation.11 While academic study in this area is essential and welcome, neither reliance on empirical research12 (despite its attractiveness to doctors and policymakers) nor the generation of increasingly ingenious ethical or legal arguments will resolve the issue of euthanasia. The debate has become stagnant, circular and divisive and it distracts our society from the on-going task of improving care and decision-making at the end of life. The most important thing is promoting the comfort, dignity and autonomy of people who are dying. Divergence about whether third-party assistance (medical or non-medical) to die is permissible reveals a deep and complex fault line in modern Western democracies, as they chart their courses based more on individual conceptions of liberty and autonomy than those of organised religion and deontological codes.13 This process is ongoing and resolution will not come easily. Society's energy should be more focused on palliative care, about which we can nearly all agree, and where modest investments have yielded excellent results for patients and families by improving care and decision-making at the end of life. There is much still to do. Euthanasia should be narrowly defined as "the deliberate action to terminate life by someone other than, and at the request of, the patient concerned",14 which is the matter at stake in the on-going societal debate. The Australian public need to have complete confidence that there is a safe and morally sound body of modern palliative care practice which is clearly and unambiguously distinguished from euthanasia. Palliative care practitioners are confident to give this re assurance. Michael Ashby Professor of Palliative Care, Monash University, Melbourne, VIC. van der Maas PJ, van Delden JJM, Pijnenborg L, Looman CWN. Euthanasia and other medical decisions conerning the end of life. Lancet 1991; 338: 669-674. Pijneneborg L, van Delden JM, Karduan WPF, et al. Nationwide study of decisions concerning the end of life in general practice in the Netherlands. BMJ 1994; 309: 1209-1212. van der Maas PJ, van der Waal G, Haverkate I, et al. Euthanasia, physician-assisted suicide, and other practices involving the end of life in the Netherlands, 1990-1995. N Engl J Med 1996; 335: 1699-1705. van der Maas PJ, van Delden JJM, Pijnenborg L. Euthanasia and other medical decisions at the end of life. Amsterdam: Elsevier, 1992. Ashby M. Hard cases, causation and care of the dying. J Law Med 1995; 3: 152-160. Reidenberg MM. Barriers to controlling pain in patients with cancer. Lancet 1996; 347: 1278. Keyserlingk EW. Assisted suicide, causality and the Supreme Court of Canada. McGill Law J 1994; 39: 708-718. Consent to Medical Treatment and Palliative Care Act 1995 (South Australia). Division 2 -- the care of people who are dying. Pijneneborg L, van der Maas PJ, van Delden JJM, Looman CWN. Life terminating acts without explicit request of patient. Lancet 1993; 341: 1196-1199. Bruera E, Miller L, McCallion J, et al. Cognitive failure in patients with terminal cancer: a prospective study. J Pain Symptom Manage 1992; 7: 192-195. Waddell C, Clarnette RM, Smith M, et al. Treatment decision-making at the end of life: a survey of Australian doctors' attitudes towards patients' wishes and euthanasia. Med J Aust 1996; 165: 540-544. Pellegrino ED. The limitation of empirical research in ethics. J Clin Ethics 1995; 6: 161-162. Somerville M. "Death talk in Canada: the Rodriguez case". McGill Law J 1994; 39: 602-617. Australian Association for Hospice and Palliative Care. Voluntary Active Euthanasia -- Position Statement, 27th October 1995. Perth: The Association, 1995. To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Michael Ashby

End-of-life decisions in Australian medical practice Helga Kuhse, Peter Singer, Peter Baume, Malcolm Clark and Maurice Rickard MJA 1997; 166: 191 For editorial comment see Van Der Weyden and Ashby Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Discussion - Acknowledgement - References - Authors' details - - - ©MJA1997 Abstract Objective: To estimate the proportion of medical end-of-life decisions in Australia, describe the characteristics of such decisions and compare these data with medical end-of-life decisions in the Netherlands, where euthanasia is openly practised. Design: Postal survey, conducted between May and July 1996, using a self-administered questionnaire based on the questionnaire used to determine medical end-of-life decisions in the Netherlands in 1995. Participants: A random sample of active medical practitioners from all Australian States and Territories selected from medical disciplines in which there were opportunities to be the attending doctor at non-acute patient deaths, and hence to make medical end-of-life decisions. Main outcome measure: Proportion of Australian deaths that involved a medical end-of-life decision, using ratio-to-size estimation based on the sampled doctors' responses to the questionnaire. The response rate was 64%. Results: The proportion of all Australian deaths that involved a medical end-of-life decision were: euthanasia, 1.8% (including physician-assisted suicide, 0.1%); ending of patient's life without patient's concurrent explicit request, 3.5%; withholding or withdrawing of potentially life-prolonging treatment, 28.6%; alleviation of pain with opioids in doses large enough that there was a probable life-shortening effect, 30.9%. In 30% of all Australian deaths, a medical end-of-life decision was made with the explicit intention of ending the patient's life, of which 4% were in response to a direct request from the patient. Overall, Australia had a higher rate of intentional ending of life without the patient's request than the Netherlands. Conclusions: Australian law has not prevented doctors from practising euthanasia or making medical end-of-life decisions explicitly intended to hasten the patient's death without the patient's request. MJA 1997; 166: 191-196 Introduction In Australia, the practice of euthanasia or physician-assisted suicide (Box 1) is unlawful, except in the Northern Territory. It is, however, widely recognised in common law (in some Australian States and Territories in statute law) that mentally competent patients have a right to refuse medical treatment, and that doctors who comply with a patient's request for non-treatment are not generally deemed to have acted unlawfully or to have practised euthanasia or physician-assisted suicide, even if their action or omission was foreseen to lead to the patient's death. Before the Northern Territory Rights of the Terminally Ill Act 1995, the only country where doctors could openly practise euthanasia was the Netherlands. Although this practice is subject to criminal law in the Netherlands, it has been long accepted by strong public support, and the Dutch Parliament has recognised that doctors practising it should not be prosecuted if they comply with certain guidelines.1,2 In 1990, the Dutch Government appointed the Remmelink Commission to review the nationwide practice of euthanasia and other end-of-life medical practices. The investigators used three different methods to ascertain the incidence of these practices. In order to facilitate comparisons with our study, we summarise the findings of their questionnaire study.3 Of all deaths in the Netherlands in 1990 (approximately 129 000), 1.7% were the result of euthanasia and 0.2% were the result of physician-assisted suicide; these deaths complied with Royal Dutch Medical Association guidelines on euthanasia. However, in a clear violation of the guidelines, 1000 deaths (0.8%) involved the administration of drugs with the explicit intention of ending the patient's life, but without the patient's explicit request. In a second nationwide study of medical end-of-life practices in the Netherlands in 1995, by van der Maas et al.,4 the corresponding findings were: euthanasia, 2.3%; physician-assisted suicide, 0.2%; and ending of life without the explicit concurrent request of the patient, 0.7%. Although recent Australian surveys have reported on doctors' attitudes about medical end-of-life decisions,5 and doctors' attitudes to and practice of voluntary euthanasia,6,7 no study has examined the number of deaths in Australia involving medical end-of-life decisions. In this study, we sought to estimate the number of deaths involving a medical end-of-life decision in Australia, to describe the characteristics of such decisions, and to compare these data with those of the Dutch studies. A comparison of medical end-of-life decisions in the Netherlands with a country where euthanasia cannot be practised openly, such as Australia, would indicate whether the Netherlands has a higher rate of ending of life without the patient's explicit request. Australia and the Netherlands have a similar population size (18 million and 15.3 million, respectively) and comparable annual death rates (7.1 and 8.7 per thousand, respectively).8 In the Netherlands in 1995 there were 135 546 deaths,3 while in Australia there were 125 771 deaths from July 1994 to June 1995.9 Methods Ethical approval Ethical approval for this study was obtained from the Monash University Standing Committee on Ethics in Research on Humans. Questionnaire We used an English version of the retrospective questionnaire used by van der Maas et al.4 Our questionnaire was based on an authoritative translation provided by the Dutch researchers, so the terminology and meanings of the questions were comparable, and contained the original 24 items used in their survey. We considered anonymity to be essential because we were seeking information about conduct for which doctors would be liable to prosecution. Therefore, unlike the study by van der Maas et al.,4 we did not conduct interviews. Grouping euthanasia and physician-assisted suicide together, our questionnaire addressed all medical end-of-life decisions, as defined in Box 1. The questionnaire examined the medical action that preceded the death, the doctor's intention, whether an explicit request from the patient was involved, whether a wish had been expressed to hasten death, whether discussion took place with the patient or others, whether the patient was competent when making the request or when participating in discussions, and the estimated length of life shortened. Most questionnaires were completed carefully and consistently. (Copies of the questionnaire are available from the authors.) Medical practitioner sample We received the addresses of 3000 doctors taken at random from a list of 27000 Australian doctors that had been extracted from the Australian Medical Masterfile Database (Australasian Medical Publishing Company, Sydney). Each doctor on the list belonged to one of 27 medical disciplines where there would be the possibility of making a medical end-of-life decision (i.e., being the attending doctor at a non-acute death) (Box 2). The sample of doctors in the study by van der Maas et al.4 consisted of those who had attended deaths where the cause of death was highly likely to have involved making a medical end-of-life decision (as determined from death certificates). Australia does not have a national Death Certificate Register for identifying causes of death and attending doctors, as in the Netherlands. Therefore, the 27 medical disciplines (also extracted from the Australian Medical Masterfile Database) in our study were chosen to be as comparable as possible with the broader categories of doctors (cardiology, surgery, internal medicine, respiratory medicine [pulmonology], neurology, general practitioners and nursing home physicians) who were attendant to 87% of hospital deaths and nearly all deaths outside hospitals in the Netherlands.4 Between May 1996 and July 1996, we sent questionnaires to the random sample of 3000 doctors in the selected medical disciplines. The sampling method was chosen to reflect the wider distribution of doctors in Australia with regard to sex, age, medical discipline and State or Territory of residence. The response rate, after a second mailing to non-respondents, was 1918 questionnaires (64%). The initial questions on the questionnaire narrowed the field of respondents to include the 1361 doctors who had attended a death within the last 12 months. These doctors were asked to recall the most recent death they had attended during that period. The field was further narrowed by excluding doctors who, in respect of that death, had had no contact with the patient until after death or where the death had been sudden and totally unexpected. Of the remaining field of 1112 doctors who had attended a death where there was an opportunity to make a medical end-of-life decision (i.e., a non-acute death), 800 doctors made a decision intended either to shorten life or foreseen as probably or certainly shortening life, and 312 doctors did not make such a decision. Statistical analysis The percentages and confidence intervals regarding doctors were computed using standard formulas for the estimation of proportions under simple random sampling.10 The sampling scheme regarding deaths was equivalent to two-stage cluster sampling. Each selected doctor was asked for details regarding only the most recent death he or she had attended in the past 12 months. Thus, the percentages of deaths and corresponding confidence intervals were computed using the usual ratio-to-size estimator for such sampling.10,11 The virtue of the ratio-to-size estimator was that it could take into account differences in the rates of death that the different doctors in our sample attended in the normal course of their duties (each doctor was asked to indicate the number of deaths they would attend on average within a certain period). For example, oncologists and general practitioners in our sample were each asked about only one death, but the differences in the number of deaths they normally attend were taken into account by the ratio-to-size method when extra polated to percentages of Australian deaths. Surveyed doctors' responses were weighted in these statistical extrapolations in proportion to the number of deaths they normally attend. A consequence of the differential weightings involved in the ratio-to-size method, however, is that there is no simple way of deriving the proportion of deaths in Australia that were preceded by a medical end-of-life decision from our sample of doctors who reported on their decision with regard to the most recent death they had attended. Furthermore, the confidence intervals take into account possible differences in attitudes towards end-of-life decisions between doctors and the fact that each respondent was asked about only one death. Results Survey response rates From the 3000 doctors who were sent questionnaires, we received responses from 1918 doctors (64%). There was no significant difference in response rate for men versus women (chi-squared test, 3.03; 1 degree of freedom [df]), nor between the States and Territories (chi-squared test, 1.94; 7 df). The response rate did, however, differ significantly with age, ranging from 74.9% for the under-35 years age group to 50.5% for the 56-65 years age group (chi-squared test, 26.73; 4 df). The response rate also differed significantly between different categories of medical discipline: there was a higher response rate from doctors in Groups A and B (116 and 340 doctors, respectively), and a lower response rate from doctors in Group C (1265 doctors) (chi-squared test, 160.4; 2 df). One hundred and ninety-seven doctors either did not state their medical discipline or indicated that it did not fall into one of these groups. (Further data on respondents' medical discipline, age, sex and State or Territory of residence are available from the authors.) Medical end-of-life decisions: medical practitioner sample Box 3 shows the characteristics of the deaths reported by the 800 doctors in our study who made medical end-of-life decisions. There were no significant differences with regard to sex (chi-squared test, 0.94; 1 df), State or Territory of residence (chi-squared test, 1.07; 7 df) or medical discipline (chi-squared test, 4.06; 3 df) between the 800 doctors who made medical end-of-life decisions and the 312 who did not make such a decision. There was, however, a marginally significant difference in the age distribution (chi-squared test, 11.50; 4 df; P=0.02). There was a higher than expected number of doctors aged between 56-65 years who did not make such a decision. The medical end-of-life decisions reported by the 800 doctors were as follows: 26 doctors (3.2%) reported euthanasia; 51 doctors (6.4%) reported ending the patient's life without the patient's explicit request; 289 doctors (36.1%) reported making a decision not to treat, of which 55 doctors (19%) reported no intention to hasten death, and 234 doctors (81%) reported an explicit intention to hasten death; and 434 doctors (54.2%) reported alleviating the patient's pain with opioids in large doses, of which 335 doctors (77.2%) reported no intention to hasten death, and 99 doctors (22.8%) reported a partial intention to hasten death (Box 3). We are planning to publish further analysis of the data at a later date. Medical end-of-life decisions: proportions of Australian deaths Box 4 shows the proportion of Australian deaths (acute and non-acute) that involved a medical end-of-life decision. The results in Box 4 and the results discussed below are based on an extrapolation of the data from Box 3 by means of ratio-to-size estimation (see Methods). A medical decision either partly or explicitly intended to hasten death or not prolong life occurred in 36.5% (±3.5%) of all Australian deaths. In almost half (17.8% [±2.9%]), there had been no explicit request from the patient, nor had there been any discussion of ending the patient's life, and the doctor did not believe that the patient had expressed a wish for death to be hastened. Euthanasia and physician-assisted suicide An estimated 1.8% (±0.6%) of all Australian deaths were the result of euthanasia or physician-assisted suicide (of which an estimated 0.1% were cases of physician-assisted suicide). Ending of life without an explicit request from the patient An estimated 3.5% (±0.8%) of all Australian deaths involved termination of the patient's life without the patient's explicit request. There was some discussion with the patient -- although not an explicit request for death to be hastened -- in 38% of these cases. In virtually all of the remaining cases, the doctor did not consider the patient competent (i.e., capable of assessing his or her situation and making a decision about it). In 0.7% of all Australian deaths, attending doctors (who were asked to give as many reasons as applied) stated that they did not discuss with the patient the possible hastening of death by prescribing, supplying or administering drugs because the patient was unconscious, demented or mentally handicapped. In 0.5% of all Australian deaths, attending doctors felt that the act of hastening death was "clearly the best one for the patient", or that "discussion would have done more harm than good". Decisions not to treat An estimated 24.7% (±3.1%) of all Australian deaths involved a decision not to treat with the explicit intention of not prolonging life or of hastening death. Of these, less than one-tenth (or 2.2% of all Australian deaths) were in response to an explicit request from the patient, and in most cases (22.5% of all Australian deaths) there was no explicit request from the patient. In 3.2% of all deaths, the doctor believed that the patient had expressed a wish for death to be hastened, but there had been no discussion with the patient, and in 5% respondents did not indicate whether the patient was involved in the decision. Therefore, in 14.3% (±2.8%) of all Australian deaths, the death was preceded by a medical decision to withhold or withdraw treatment with the explicit intention of not prolonging life or of hastening death, despite the fact that the decision was not based on an explicit request from a patient, there was no discussion with the patient about whether to hasten death by the omission of treatment, and the doctor did not believe that the patient had expressed a wish for death to be hastened. In almost all of these cases (14.1% of all deaths) the doctor did not consider the patient capable of assessing his or her situation and making a decision about it. In 0.16% of all Australian deaths, the doctor did consider the patient capable of assessing his or her situation and making a decision about it, but intentionally hastened death by forgoing treatment, without discussing this with the patient. In 10.5% (±2.7%) of all Australian deaths, attending doctors (who were asked to give as many reasons as applied) stated that they did not discuss with the patient the possible hastening of death by withholding or withdrawing treatment because the patient was unconscious. Dementia or mental handicap was offered as the reason in 2.6% of all Australian deaths. In 1.6% of all Australian deaths, the attending doctor felt that the decision "was clearly the best one for the patient" or "discussion would have done more harm than good". Alleviation of pain and/or symptoms with opioids In 6.5% (±1.1%) of all Australian deaths, doctors prescribed opioids (morphine or a comparable drug) with a dual intention: in part, to alleviate pain and symptoms and, in part, to hasten death. Drug doses were large enough to have, in the judgement of the respondent and with regard to the particular death, a life-shortening effect. In 0.9% of all Australian deaths, doctors had partly intended to hasten death by alleviating pain and/or symptoms using opioids on the basis of an explicit request; and in 3.2% there was either some discussion with the patient, or the doctor believed that the patient had expressed a wish (but not an explicit request) for death to be hastened. In 2.4% of all deaths, doctors had partly intended to hasten death by this practice, despite the fact that there was no explicit request, no discussion with the patient, and the doctor did not believe that the patient had expressed a wish for death to be hastened. Amount of time by which life was shortened Medical decisions that were explicitly or partly intended to hasten death or not prolong life generally brought death forward by relatively short periods, according to doctors' estimates. Of the 24.7% (±3.1%) of all Australian deaths that involved a decision to forgo treatment with the explicit intention of hastening death or not prolonging life, the decision was estimated to hasten death by more than a week in 3.6% of all Australian deaths. Of the 5.3% of all Australian deaths that were caused by the prescription, supply or administration of drugs explicitly intended to hasten death, life was estimated to have been shortened by more than a week in 1.1% of all Australian deaths. Discussion One of the main findings of our study was that 30% (±3.3%) of all Australian deaths were preceded by a medical decision explicitly intended to hasten the patient's death: doctors prescribed, supplied or administered drugs with the explicit intention of ending the patient's life in 5.3% (±1%) of these deaths, and withdrew or withheld life-prolonging treatment with the explicit intention of not prolonging life or of hastening death in 24.7% (±3.1%) of these deaths. Our study shows that Australia had a significantly higher rate of intentional ending of life without the patient's consent, both through the administration of drugs and by withholding or withdrawing treatment, than the Netherlands. Overall, 36.5% (±3.5%) of all Australian deaths involved a medical decision either partly or explicitly intended to hasten death or not prolong life, compared with 19.5% of deaths in the Netherlands.4 Further comparisons with the data from the Netherlands are shown in Box 5. The difference in the rates of euthanasia between the two countries was not statistically significant. However, the rates of intentionally ending life without an explicit request from the patient were significantly higher in Australia than in the Netherlands (P < 0.0001). In 22.5% (±3.1%) of all Australian deaths, doctors withheld or withdrew treatment from patients, without the patient's explicit request, with the explicit intention of ending life. No comparable 1995 figure for the Netherlands was available (the 1991 figure was 5.3%), but the 1995 figure for all decisions to forgo treatment with an explicit intention of hastening death or not prolonging life in the Netherlands was 13.3%.4 If we classify euthanasia as all cases in which death is "intentionally accelerated by a doctor,"12 30% of all Australian deaths (or 37000 cases) would be cases of euthanasia. The comparable 1995 figure for the Netherlands was 16.6%. The response rate of 64% to our questionnaire was adequate to give a broad picture of medical end-of-life decisions in Australia, but all postal surveys are subject to some degree of non-response bias. The validity of our observations and comparisons is limited by the degree to which our study can be compared with the studies from the Netherlands. Although we strove to obtain a sample population of Australian doctors as comparable as possible to the sample in the study by van der Maas et al.,4 the 27 medical disciplines we selected may not have matched exactly the groups of doctors in their study. Furthermore, in our study there was a higher response rate from doctors whose medical discipline belonged to Groups A and B, and a lower response rate from those in Group C (Box 2). An analysis of the responses of doctors in each of these categories indicates that, in so far as this response bias had any effect on our results, this effect would have been to reduce the reported rate of euthanasia and ending of a patient's life without an explicit request. Cultural differences between Australia and the Netherlands could have accounted for some of the differing responses to the questionnaire. In the Netherlands, the community has a different relationship with primary care doctors compared with Australians, which may account for some of the differences in results. In the Netherlands, most primary care is provided by the huisarts ("home doctor"), the general practitioner or family doctor, either in the patient's home or in the doctor's home surgery. All Dutch patients have a personal huisart, who usually serves a practice of about 2300 people, lives in the area and makes frequent house calls when a patient is ill. This allows for close and enduring contact between the doctor and the patient, and distinguishes the delivery of primary care in the Netherlands from the increasingly institutionalised delivery of primary care in Australia. However, our study undermines suggestions that the rate at which doctors intentionally end patients' lives without an explicit request is higher in a country where euthanasia is practised openly (the Netherlands) than in a comparable country which has not allowed euthanasia to be practised openly, such as Australia. Although Australian law recognises a right to refuse treatment, it generally prohibits the intentional termination of life, whether by act or omission.13 Our findings, together with the previously cited studies of doctors in Victoria and New South Wales,6,7 suggest that Australian law has not prevented the practice of euthanasia or the intentional ending of life without the patient's consent. Our study shows that, while 30% (±3.3%) of all Australian deaths were preceded by an action or omission explicitly intended to end the patient's life, in only 4% was the decision taken in response to an explicit request from the patient. Far more doctors in our sample intentionally hastened death by forgoing (withholding or withdrawing) treatment than by prescribing, supplying or administering drugs with the explicit intention of ending life. For the purposes of this comparative study, we used the same narrow definition of euthanasia (the administration of drugs with the explicit intention of ending the patient's life, at the patient's request) that was used by van der Maas et al.4 Traditionally, "euthanasia" has been defined more broadly: "an action or an omission which of itself or by intention causes death, in order that all suffering may in this way be eliminated."14 This study suggests that the contemporary focus on euthanasia in the narrow sense may be too limited, at least if the aim is to prevent patients having their lives shortened by medical end-of-life decisions being made without their consent. Our study raises the question of why some Australian doctors choose intentionally to end the lives of some of their patients without the patients' consent, especially in situations where the patient is competent and could be consulted. While this issue remains the subject of further empirical research, it may be that, because existing laws prohibit the intentional termination of life, doctors are reluctant to discuss medical end-of-life decisions with their patients lest these decisions be construed as collaboration in euthanasia or in the intentional termination of life. Acknowledgement This study was supported by a grant from the National Health and Medical Research Council. Responsibility for the views expressed is that of the authors alone. References The Royal Dutch Medical Association issues revised guidelines on euthanasia. Int Digest Health Legislation 1996; 47: 401-405. van der Wal G, Dillmann RJM. Euthanasia in the Netherlands. BMJ 1994; 308: 1346-1349. van der Maas PJ, van Delden JJM, Pijnenborg L. Euthanasia and other medical decisions concerning the end of life. Lancet 1991; 338: 669-674. van der Maas PJ, van der Wal, Haverkate I, et al. Euthanasia, physician-assisted suicide, and other medical practices involvingthe end of life in the Netherlands, 1990-1995. N Engl J Med 1996; 335: 1699-1705. Waddell C, Clarnette RM, Smith M, et al. Treatment decision-making at the end of life: a survey of Australian doctors' attitudes towards patients' wishes and euthanasia. Med J Aust 1996; 165: 540-544. Kuhse H, Singer P. Doctors' practices and attitudes regarding voluntary euthanasia. Med J Aust 1988; 148: 623-627. Baume P, O'Malley E. Euthanasia: attitudes and practices of medical practitioners. Med J Aust 1994; 161: 137-144. Encyclopaedia Britannica 1996 Year Book. Chicago: Encyclopaedia Britannica, Inc. 1996: 554, 679. Australian Bureau of Statistics. Australian Demographic Statistics, June 1996. Canberra: AGPS, Cat. No. 3101.0. Cochran WG. Sampling techniques. 2nd edition. New York: Wiley, 1963: section 3.2, 11.6: 49-52, 300-303. Scheaffer RL, Mendenhall W, Ott L (editors). Elementary survey sampling. 4th edition. Boston: PWS-Kent, 1990, section 9.5: 294-296. Keown J. Euthanasia in the Netherlands: sliding down the slippery slope? In: Keown J, editor. Euthanasia examined: ethical, clinical and legal perspectives. Cambridge: Cambridge University Press, 1995: 261-296. Crimes Act 1900 (NSW), s. 19(1)(a). Sacred Congregation for the Doctrine of the Faith: Declaration on Euthanasia, Vatican City, 1980: 6. (Received 20 Dec 1996, accepted 22 Jan 1997) Authors' details Centre for Human Bioethics, Monash University, Clayton, VIC. Helga Kuhse, PhD, Director; Peter Singer, FAHA, FASSA, Deputy Director; Maurice Rickard, PhD, NHMRC Research Officer. School of Community Medicine, University of New South Wales, Sydney, NSW. Peter Baume, MD, FAFPHN, Professor. Department of Mathematics, Monash University, Clayton, VIC. Malcolm Clark, PhD, Senior Lecturer. No reprints will be available from the author. Correspondence: Associate Professor H Kuhse, Centre for Human Bioethics, Monash University, Clayton, VIC 3168. E-mail: helga.kuhse AT arts.monash.edu.au - - - To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. 1: Definitions of medical end-of-life decisions4 Euthanasia:The administration of drugs with the explicit intention of ending the patient's life, at the patient's request. Physician-assisted suicide:The prescription or supplying of drugs with the explicit intention of enabling the patient to end his or her own life. Ending of life without the patient's explicit request:The administration of drugs with the explicit intention of ending the patient's life, without a concurrent, explicit request by the patient. Alleviation of pain and symptoms with opioids: The administration of doses large enough so that there was a probable life-shortening effect. A decision not to treat:The withholding or withdrawing of potentially life-prolonging treatment. 2: Medical disciplines in Australia that involve the possibility of doctors making medical end-of-life decisions* Group A: Emergency medicine, intensive care, neonatology, medical oncology, palliative care, renal medicine, cardiothoracic surgery. Group B: Cardiology, clinical haematology, geriatric medicine, general medicine/general physician, immunology, infectious diseases, radiation oncology, respiratory medicine, abdominal surgery, neurosurgery, vascular surgery, gynaecological oncology, otorhinolaryngology. Group C: Breast surgery, endocrinology, gastroenterology, general practice, general surgery, neurology, urological surgery * Participating doctors were asked to nominate the group containing the medical discipline in which they practise. Medical disciplines were extracted from the Australasian Medical Masterfile Database. 3: Characteristics of medical end-of-life decisions reported by 800 Australian doctors 4: Estimated proportion of medical end-of-life decisions in Australia 5: Comparison of medical end-of-life decisions in Australia and the Netherlands*

Helga Kuhse · Peter Singer · Peter Baume · Malcolm Clark · Maurice Rickard

The euthanasia debate The end of life: We need a humane and informed framework, not only a medical model, to deal with death and dying MJA 1996; 165: 535 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1996 Dealing with death and dying (which includes requests for euthanasia) is an integral part of the practice of medicine. Surveys of health care professionals in Australia and overseas now consistently show that a considerable proportion of them support euthanasia or physician-assisted suicide under certain conditions. 1-4 A minority of health care professionals also admit to having practised euthanasia or physician-assisted suicide. For example, the most recent Australian survey found that one in seven doctors had helped a 0atient to die. 5 Other surveys have reported that 19 per cent of doctors in South Australia 6 and 29 per cent of doctors in Victoria had taken active steps to hasten death in patients with terminal or incurable disease who had requested they do so . 7 In one of the most detailed surveys of the practice of euthanasia in Holland, van der Maas et al. 4 found that in 1.8 per cent of all deaths a lethal drug was administered, at the patient's request, to end life, and in 38 per cent of all deaths doctors had taken medical decisions concerning the end of life that may have shortened the patient's life. van der Maas et al. 4 concluded that medical decisions concerning the end of life were common in medical practice and should be the subject of increased research, teaching, and public debate. Other recent international studies have reported similar findings. 1,2 Surveys of community attitudes also show increasing support for euthanasia and physician-assisted suicide. In 1962 only 47 per cent of Australians, when asked "if a patient in great pain, with no hope of recovery, asks for a lethal dose, should a doctor be allowed to administer one?", replied in the affirmative. In 1996, 76 per cent gave the same response. Correspondingly, the response "not give lethal dose" declined from 39 per cent in 1962 to 17 per cent in 1996. 8 The study by Waddell et al. reported in this issue of the Journal makes a significant contribution to the euthanasia debate in Australia. Unlike most previous Australian studies that elicited doctors' responses to general questions concerning end-of-life treatment decisions, 5,6 this study used real and comprehensive clinical scenarios. Based on a recent Canadian study, 9 Waddell et al. used a questionnaire that presented clinical cases in which the patients' sociodemographic characteristics, mental competence, severity of illness and wishes for treatment varied. (One of these clinical vignettes involved the issue of physician-assisted death requested by a 56-year-old competent man with a debilitating, but not imminently terminal, condition.) The respondents were asked to state what they would do. A major finding was that Australian doctors did not make consistent decisions in the treatment of severely and terminally ill patients. The doctors' decisions were influenced by their medical training and sociodemographic background, and the data suggested that there were no clear criteria to guide doctors in managing these clinical situations. Waddell et al. suggest that the capacity of doctors to treat severely and terminally ill patients in accordance with the patients' wishes may be aided by the informed-consent process, as well as by advance care planning. The study also revealed that only a small minority of doctors would have complied with the wish of the patient for euthanasia. This study again raises questions about medical decisions concerning the end of life -- questions that deserve an informed public debate. Why are most doctors against the legalisation of euthanasia? 3 Are public interests in Australia served by existing medical practices that deal with the dying patient? Several factors may explain the opposition of doctors to euthanasia. First, in general, in modern medicine death is viewed as a failure; hence the reluctance of medical professionals to reinforce this perception by accepting euthanasia and physician-assisted suicide. The response of modern medicine to the complex set of problems surrounding the dying patient is to provide effective and accessible palliative care. Second, the various surveys mentioned earlier suggest that dealing with death and dying is seen as an integral part of the practice of medicine. Doctors would prefer to keep this management within their professional practice to allow them the flexibility to respond to the very complex realities of differing clinical situations, in which decisions must take into account the unique nature of the suffering of the individual patient and the availability of the appropriate medical facilities to care for the patient. The regulation of death and dying through a formal legal process could make it difficult for doctors to respond to the individual needs of the patient and could also subject doctors to unreasonable and extended legal scrutiny. The intrusiveness of legislation into the doctor-patient relationship was alluded to by Brendan Nelson, the former federal President of the Australian Medical Association, when he stated: "We can't reach for a legislative pen every time we have a problem or we see something in life we'd like to regulate. In the end doctors will continue to do what they believe to be right in the interests of the patient and his or her immediate family." Dr Nelson also said that euthanasia should not be legalised, as this could lead to its unethical use. 10 The opposition of doctors to euthanasia and physician-assisted suicide may also be related to their "self-image". As Lickiss 11 points out, putting someone to death will fundamentally change the character of the doctor; and the contribution of doctors to carrying out requests for euthanasia may have profound effects on their image in our society. Doctors see themselves as the bringers of life, hope and healing -- not as the bringers of death. Legalisation of euthanasia also raises a serious moral dilemma for those doctors who may be opposed to it on religious or ethical grounds. The community's unease about the legalisation of euthanasia is related to the concerns of some religious and ethnic groups that, besides violating the ultimate human value -- the sanctity of life -- such legislation may render the less privileged and the poor in the community more vulnerable to unethical practices. However, notwithstanding the concerns of the medical profession and some key groups in society, the debate about the right of an individual to make a decision about his or her own death is not going to disappear. Society will ultimately have to resolve the issue by balancing two central human values: sanctity of life and human dignity. Legislation now before the European Parliament stipulates that human life cannot be reduced to mere biological functions. Is it desirable that, as a civilised society, in our efforts to protect and celebrate the sanctity of life we may have to compromise human dignity? A civilised society must protect, cherish and celebrate both the sanctity of life and human dignity. 3 Society needs an informed and humane framework to deal with death and dying. In Australia, the Northern Territory Rights of the Terminally Ill Act presents an opportunity to assess whether the legalisation of euthanasia may help us to meet this need. Allowing this legislation to function would be consistent with the values of a pluralistic democracy. Riaz Hassan Professor of Sociology, The Flinders University of South Australia, Adelaide, SA Asch DA. The role of critical case nurses in euthanasia and assisted suicide. New Engl J Med 1996; 334: 1374-1379. Emanuel EJ, Fairclough DL, Daniels ER, Clarridge BR. Euthanasia and physician-assisted suicide: attitudes and experience of oncology patients, oncologists, and the public. Lancet 1996; 347: 1805-1810. Hassan R. Euthanasia and the medical profession: an Australian study. Aust J Social Issues 1996; 31: 239-252. van der Maas PJ, van Delden JJM, Pijnenborg L, Looman CWN. Euthanasia and other medical decisions concerning the end of life. Lancet 1991; 338: 669-674. Baume P, O'Malley E. Euthanasia: attitudes and practices of medical practitioners. Med J Aust 1994; 161: 137-144. Stevens C, Hassan R. Management of death, dying and euthanasia: attitudes and practices of medical practitioners in South Australia. J Med Ethics 1994; 20: 41-46. Kuhse H, Singer P. Doctors' practices and attitudes regarding voluntary euthanasia. Med J Aust 1988; 148: 623-627. Walsh K-A . Will to die: Australians expect the freedom to manage their lives -- so why not their deaths? The Bulletin , September 17, 1996. Molloy W, Guyatt GH, Alemayehu E, et al. Factors affecting physicians' decisions on caring for an incompetent elderly patient: an international study. Can Med Assoc J 1991; 145: 947-952. Zinn C. Euthanasia bill divides Australian doctors and MPs [News]. BMJ 1995; 310: 421. Lickiss N. Chapter In: Chapman S, Leeder S, editors. The last right? Australians take sides on the right to die. Melbourne: Mandarin 1995. - - To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Riaz Hassan

Treatment decision-making at the end of life: a survey of Australian doctors' attitudes towards patients' wishes and euthanasia Charles Waddell, Roger M Clarnette, Michael Smith, Lynn Oldham and Allan Kellehear MJA 1996; 165: 540 For editorial comment, see Hassan Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Survey participants - Questionnaire - Statistical analysis - Results - Case scenarios 1 and 2 - Case scenario 3 - Case scenario 4 - Responses to request for assisted death - Factors influencing choice of treatment - Factors influencing doctors' responses to patient's request for assisted death - Discussion - Acknowledgements - References - Authors' details - - ©MJA1996 Abstract Objective: To examine factors that influence medical practitioners' treatment decisions for patients with life-threatening or terminal illnesses. Design: Postal survey, conducted between September and November 1995, of a self-administered questionnaire, describing four clinical case scenarios, to a random sample of 2172 Australian doctors in all States and Territories. Respondents were asked to prescribe treatment for the patients described in the scenarios. Patients' characteristics varied in terms of mental competence, illness severity, prognosis, the presence of advance directives, request for assisted death, and sociodemographic factors. The respondents' sociodemographic and medical training characteristics were also obtained. Setting: Random national sample of all active medical practitioners. Participants: Hospital trainees, general practitioners, physicians, palliative care practitioners and surgeons were surveyed. A response rate of 73% was achieved. Main outcome measures: Frequency of prescription of supportive, acute or intensive treatment for patients in the four clinical scenarios based on respondents' sex, religion, medical training and country of medical degree. Results: Three main findings were: (i) doctors did not make consistent decisions, but their decisions varied systematically by sociodemographic and medical training factors; (ii) doctors generally adhered to patient and family wishes when these were known; (iii) doctors did not generally adhere to a patient's request for assisted death. Conclusion: Treatment provided is significantly determined by the individual characteristics of the doctor and not solely by the nature of the medical problem. Participation in the informed-consent process and in the preparation of advance health care directives would enable practitioners to be familiar with patient and family wishes and could reduce variations of treatment related to sociodemographic and medical training factors. Stronger empirical data on the way that treatment decisions are made could provide the basis for an informed euthanasia policy. MJA 1996; 165: 540-544 Introduction Advances in medical technology have allowed the medical profession to maintain life to an extent that is beyond the limits of what many would consider reasonable quality. 1-5 The use of advanced technology, particularly for terminal illnesses, has created a complex array of ethical, moral and legal issues, 6-8 and has been accompanied by opportunities for greater patient participation in treatment decision-making and individual involvement in choosing care. 1,3,4,8 The most contentious aspect of these developments seems to be the promotion of requests for physician-assisted death -- euthanasia. 1,6,9 However, the emphasis on euthanasia has been tempered by a greater focus on palliative-care principles in the management of patients with terminal and life-threatening illnesses. 10-12 A major impediment to the consideration of these issues is the lack of strong empirical data to indicate the way in which treatment decisions are reached. The process that leads to decision-making and action in clinical practice is unclear, and the factors that determine who ultimately makes a treatment decision, what influences treatment choice, and how the treatment is carried out have yet to be established. Although the idea of informed consent implies significant patient participation in decision-making, there is no evidence that such participation actually occurs. Indeed, many patients are incapable of giving informed consent. Doctors and family members usually make decisions in such circumstances, but the path for this process is unknown. Some authors have advocated the use of advance health care directives that can advise doctors of a patient's wishes regarding care should he or she become incompetent. 2 Several studies, surveying both the general public and health professionals, have examined areas relevant to these issues, including reactions of family members to the death of loved ones; 8,10,13 attitudes of doctors to death, dying 1-5 and palliative care; 12,14 doctors' experience with requests for euthanasia; 1,9,15 and factors that influence doctors' choice of treatment. 1-5,7 However, while many of these reports discuss the legal, ethical, medical and philosophical problems confronting health professionals, they do not address the factors that influence the health professionals to act as they do. To examine the factors that influence doctors' decisions on treatment for patients with life-threatening or terminal illnesses, we presented doctors with actual comprehensive clinical scenarios described in a questionnaire and asked them to state what they would do. Methods Survey participants A postal survey was conducted between September and November 1995. An initial mailing of the questionnaire was sent to a national sample of 2016 doctors with a workload of 50 or more services (i.e., items billed to Medicare) per quarter, randomly selected by the Health Benefits Division of the then Commonwealth Department of Human Services and Health. The questionnaire was also posted to all Australian palliative care practitioners registered with the Australian and New Zealand Society of Palliative Medicine ( n = 156). Each practitioner was asked to complete and return the questionnaire anonymously. After two weeks, a reminder card was sent to all in the sample. Of the 2172 posted, 1588 usable questionnaires were returned (3% trainees [interns, residents, registrars]; 41% general practitioners; 10% palliative care practitioners; 46% specialists). The response rate, 73.1%, compared favourably with that of Baume and O'Malley (76.1%). 9 Eighty-seven questionnaires were returned because they were incorrectly addressed. Questionnaire The questionnaire was based upon that used by Molloy and colleagues 2 in Canada. We adapted their case scenarios to the 1995 Australian context, particularly including the issue of physician-assisted death. The questionnaire presented scenarios based on clinical cases (see Box 1). The doctors were asked to choose one of three treatment options in each scenario: 1. Supportive care -- keep warm, dry and pain-free; use only those measures that enhance comfort or minimise pain; start intravenous line only if it improves comfort; perform no x-rays or blood tests and give no antibiotics unless such measures are intended only to improve comfort; 2. Acute care -- may involve transfer to acute-care facility; perform emergency surgery if necessary; do not ventilate (except during and after surgery); carry out all acute-care interventions, except for admission to the intensive care unit or the coronary care unit and performing organ transplantation; 3. Intensive care -- all possible interventions necessary to maintain life. The doctors were also asked how they would respond to a patient's request for assisted death (scenario 4). Three possible responses were listed: 1. Refuse request for assisted death, and explain and provide palliative (supportive) care only; 2. Agree to assist death by providing the means (e.g., by prescribing lethal medication); and 3. Agree to assist death by active intervention (e.g., by administering a fatal dose of narcotic analgesic). To assess the degree to which six independent variables -- legal, ethical, religious and economic factors and patient's and family's wishes -- influenced the choice of treatment, the doctors were asked to complete a five-point Likert-type scale following each scenario. Finally, the questionnaire addressed the sociodemographic characteristics (sex; religious background) and the training of the participating doctors (country of basic medical degree; number of years qualified; level of medical training). The study was approved by the Human Rights Committee, the University of Western Australia. Statistical analysis Our analysis cross-tabulated the aggregated responses to the treatment options of the four clinical scenarios with the sociodemographic and medical training factors to examine whether medical decision-making varied significantly depending on these factors. Statistical significance was tested by chi-squared tests, with exact probability levels being reported. 16 We examined the strength and direction of the relationships among treatment options for the four clinical scenarios and the six independent variables. Somers' d correlation matrix is presented with chi-squared levels of statistical significance of 0.01 and 0.001. 16 Stepwise regression analysis was used to assess the degree of variance explained by the six independent variables in the doctors' responses to the request for physician-assisted death. Results Case scenarios 1 and 2 In the 80-year-old incompetent woman with life-threatening and acute illnesses without the medical directive (Box 2, scenario 1), there were significant differences among doctors' choices by all sociodemographic and medical training factors, except for religion. In the 80-year-old incompetent woman with life-threatening and acute illnesses with a medical directive for acute treatment (Box 2, scenario 2), there were significant differences by religion and medical training factors, but no significant difference between male and female doctors. This woman was twice as likely to receive acute care than was the woman without a medical directive. Case scenario 3 In their treatment choices for the 33-year-old competent woman with terminal and acute illnesses insisting on intensive care, there were significant differences among the doctors by medical training factors but not by sociodemographic factors (see Box 2). Doctors from non-Western countries were more likely to honour the patient's request for intensive care than were Western-trained practitioners; however, most doctors chose acute care for this patient. Older doctors and those not trained in palliative care were also more likely to honour the patient's request for intensive care. Case scenario 4 Nearly all doctors (more than 93%) chose supportive care for the treatment of the 56-year-old competent man with motor neurone disease who requested physician-assisted death. The only significant difference was between doctors trained in Western and non-Western countries, with a greater percentage of the latter choosing more interventionist medical treatment. Responses to request for assisted death Box 2 shows three notable findings on the doctors' responses to the request for assisted death: 1. Most doctors reported that they would provide palliative care only to this patient (explaining the grounds for the decision); 2. The percentage of doctors who were willing to provide only the means to assist death was larger than the percentage who were willing to intervene actively to assist death (frequently referred to as active euthanasia); 3. Female, Catholic, Western-trained and older doctors, as well as palliative care practitioners, were the least willing to engage in any form of euthanasia; agnostic/atheist doctors were the most willing to engage in some form of euthanasia; and doctors trained in non-Western countries were more likely than Western-trained doctors to be willing to provide the means to assist death, but were less likely than Western-trained doctors to actively intervene to assist death. Factors influencing choice of treatment Box 3 presents the Somers' d correlation matrix for scenario treatments with factors influencing treatment choice. For the incompetent 80-year-old woman without the medical directive (scenario 1), legal and ethical factors showed a significant positive correlation with the treatment choice, whereas the patient's and the family's wishes had a significant negative correlation with treatment choice. For the incompetent 80-year-old woman with a medical directive (scenario 2), cost and the patient's and family's wishes were significantly related to the treatment choice, the latter two of these three independent variables being positively associated with treatment choice. For the 33-year-old competent woman insisting on intensive treatment (scenario 3), ethics and the patient's and family's wishes had a significant relation to treatment choice. For the 56-year-old man with motor neurone disease who requested assisted death (scenario 4), none of the factors examined were significantly related to treatment choice. Across the matrix, patient's wishes seemed to have a significant positive relationship with doctors' treatment choice in scenarios 2 and 3, but not in scenario 1 (patient's wishes not known) or in scenario 4 (the patient who requested assisted death). This pattern of correlation suggests face validity for this set of questions. It should be noted that, while some coefficients are statistically significant, they do not suggest strong relationships between the variables. Factors influencing doctors' responses to patient's request for assisted death Stepwise regression analysis of the six independent variables that influenced the doctors' responses to the patient's request for assisted death showed three of these variables to be significant: patient's wishes (F = 67.0; P < 0.001), ethical factors (F = 38.8; P < 0.001) and religious beliefs (F = 27.2; P < 0.001). However, together, these three variables still explained only seven per cent of the variance in doctors' responses to the patient's request for assisted death. Legal (F = 0.028; P = 0.87) and cost factors (F = 2.618; P = 0.11) and family wishes (F = 0.017; P = 0.90) were not significant in predicting doctors' responses to the patient's request for assisted death in this analysis. Discussion A major finding of this study was that doctors did not make consistent decisions on the treatment of severely ill and terminally ill patients at the end of life. The data suggest that there are no uniform criteria to guide doctors in managing such clinical situations. If these decisions are left solely to doctors then the outcome will vary systematically according to medical training and sociodemographic factors. The data also show that doctors generally adhered to patients' wishes, both those expressed contemporaneously and those expressed via advance directives. The doctors also considered the wishes of family members to be important in making their treatment choices. Doctors' capacity to treat patients according to their wishes (and, if necessary, according to the wishes of their families) could be enhanced in two ways: 1. By engaging competent patients (and their families, if required) in comprehensive discussions of treatment options and likely outcomes -- in short, by participating in the informed-consent process. 2. By developing and implementing methods for advanced care planning (advance directives) so that patients can inform doctors of the care they would want if they were to suffer severe and terminal illness and become incompetent. The first practice, informed consent, may be required by law. However, the concept of informed consent presents problems in a multicultural society, not only because of potential communication problems, but also because of cultural differences in such matters as "truth telling" about the seriousness of an illness. 17 The second practice, the use of advance care planning, is accepted in principle (although its manner of implementation is debated) in North America and the United Kingdom. The practice is rarely even discussed in Australia. In multicultural Australia, research that could inform policy on the acceptability and the implementation of these two practices is lacking. Such research would seem to be imperative. With respect to euthanasia, this study showed that few doctors would have complied with the wish of the patient who requested assisted death. Baume and O'Malley 9 speculated that such reluctance was a function of the illegality of the action. Our data do not support this speculation. While patients' wishes, and ethical and religious factors for doctors (as with Baume et al. 18 ), seem to be more efficient predictors than legal factors, even the three former variables explain little of the variance in doctors' response to this request for assisted death (only seven per cent for the three variables together). As an alternative to the speculation of Baume and O'Malley, 9 it may be that, in Australia today, doctors believe that assisting a patient to die is an act that negates what they perceive to be the very essence of their profession. The different ways that doctors perceive this indefinable essential quality (that is, what it means to each of them to be a doctor) may explain the variations in their decision-making. As Lickiss 19 writes: There will always be differences of opinion on profound matters in a free society, but being put to death with one's consent is not a private matter, for it strikes at the foundations of what we are, and affects not only the one put to death but the one who carries it out. Our acts shape us, and the act of putting another person to death must change us. If we are doctors, it strikes at the core of what we should be in society: bringers of life, of hope, of healing, of comfort, sometimes bringers of bad news, companions on the way. But not bringers of death. Hunt, 20 an apparent proponent of some forms of euthanasia, notes that palliative-care practitioners are firmly opposed to physician-assisted death. Other medical practitioners are also opposed. 6,15 Nevertheless, despite the finest symptom management, some terminally ill patients make serious requests for assisted death. 21,22 Perhaps, if some form of euthanasia is to be available to these patients, medical practitioners may not be the most appropriate group to carry out the request. Certainly, it would be prudent to investigate doctors' perceptions of what it means to them to be a doctor in Australia today. Furthermore, as stated at the beginning of the paper, a major impediment to informed consideration of the issue of euthanasia in Australia is the lack of strong empirical data. While we have added to and improved the data by this study, in which we questioned a national sample of doctors about their end-of-life treatment decisions in the specific clinical scenarios described, we did not attempt the difficult task of obtaining empirical data related to clinical decision-making at the bedside. Data drawn from strong research into this decision-making process could provide important information before policy on euthanasia is drafted and implemented. Acknowledgements This research was funded by the Commonwealth Department of Health and Family Services, Canberra. References Stevens CA, Hassan R. Management of death, dying and euthanasia: attitudes and practices of medical practitioners in South Australia. J Med Ethics 1994; 20: 41-46. Molloy W, Guyatt GH, Alemayehu E, et al. Factors affecting physicians' decisions on caring for an incompetent elderly patient: an international study. Can Med Assoc J 1991; 145: 947-952. Kelner MJ, Bourgealt IL. Patient control over dying: responses of health care professionals. Soc Sci Med 1993; 36: 757-765. Solomon MZ, O'Donnell L, Jennings B, et al. Decisions near the end of life: Professional views on life- sustaining treatments. Am J Public Health ; 1993; 83: 14-22. Christakis NA. Physician characteristics associated with decisions to withdraw life support. Am J Public Health 1995; 85: 367-372. Komesaroff PA, Lickiss JN, Parker M, Ashby MA. The euthanasia controversy: decision-making in extreme cases. Med J Aust 1995; 162: 594-597. Kaufman SR. Decision making, responsibility, and advocacy in geriatric medicine: physician dilemmas with elderly in the community. Gerontologist 1995; 35: 481-488. Ashby M, Wakefield M. Attitudes to some aspects of death and dying, living wills and substituted health care decision-making in South Australia: public opinion survey for a parliamentary select committee. Palliat Med 1993; 7: 273-282. Baume P, O'Malley E. Euthanasia: attitudes and practices of medical practitioners. Med J Aust 1994; 161: 137-145. Maddocks I. Good palliative care orders. Palliat Med 1993; 7: 35-37. Baume P. Living and dying: a paradox of medical progress. Med J Aust 1993; 59: 792-794. Wakefield MA, Beilby J, Ashby MA. General practitioners and palliative care. Palliat Med 1993; 7: 117-126. Seale C, Addington-Hall J. Euthanasia: the role of good care. Soc Sci Med 1995; 40: 581-587. Allbrook D. Palliative care in the 1990s? Med J Aust 1991; 155: 286-287. Anderson JG, Caddell DP. Attitudes of medical professionals toward euthanasia. Soc Sci Med 1993; 37: 105-114. Siegel S. Nonparametric statistics for the behavioural scientist . London: McGraw-Hill 1956. Waddell C, McNamara B. The stereotypical fallacy: a comparison of Chinese- and Anglo-Australians' thoughts about death-related matters. Presented at the Annual Australian Sociology Association Meeting, Newcastle, NSW. December 1995. Baume P, O'Malley E, Bauman A. Professed religious affiliation and the practice of euthanasia. J Med Ethics 1995; 21: 49-54. Lickiss, N. Chapter in: Chapman S, Leeder S, editors The last right? Australians take sides on the right to die. Melbourne: Mandarin, 1995: 98. Hunt RW. The hospice movement matures. Med J Aust 1996; 164: 452-453. Stephany TM. Assisted suicide: how hospice fails. Am J Hospice Palliat Care 1994; 11: 4-5. Peteet JR. Treating patients who request suicide: a closer look at the physician's role. Arch Fam Med 1994; 3: 723-727. (Received 15 May, accepted 29 Jul 1996) Authors' details The University of Western Australia, Nedlands, WA. Charles Waddell, PhD, Senior Lecturer in Anthropology. Department of Geriatric Medicine, Osborne Park Hospital, Perth, WA. Roger M Clarnette, MB BS, FRACP, Consultant Physician. Silver Chain Hospice Care Services, Perth, WA. Michael Smith, MB BS, MRACMA, Director of Clinical Services. The Cancer Foundation Cottage Hospice, Perth, WA. Lynn Oldham , BN(Hons), Clinical Nurse Specialist. Turning Point Alcohol and Drug Centre, Fitzroy, VIC. Allan Kellehear, PhD, Professor, and Head of Research Development. No reprints will be available. Correspondence: Dr Charles Waddell, Department of Anthropology, The University of Western Australia, Nedlands, WA 6907. E-mail: cwaddell AT uniwa.uwa.edu.au - - To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Charles Waddell · Rodger M Clarnette · Michael Smith · Lynn Oldham · Allan Kellehear

Teaching resuscitation on the newly deceased: do we want to know? Time for public scrutiny and debate MJA 1996; 165: 412-413 Using the newly deceased for the teaching of resuscitation techniques has been debated in the mainstream journals and medical ethics literature overseas for more than a decade, but in this issue of the Journal (page 445) Ginifer and Kelly bring the subject into the public domain for the first time in Australia. In their survey of selected Australian emergency departments, the practice of teaching resuscitation techniques using the bodies of newly deceased patients was found to be widespread but relatively infrequent. Consent from relatives was rarely obtained, and most emergency departments had no written policies governing this practice. Ginifer and Kelly question the educational need for such experience and raise ethical and legal issues. In considering the need for teaching of resuscitation techniques, it is important to distinguish between minimally invasive procedures such as endotracheal intubation (by far the most commonly practised procedure), central venous cannulation and pericardiocentesis and more extensive procedures such as tracheostomy or emergency thoracotomy. The performance of emergency thoracotomy for any reason in the emergency department is exceedingly rare, typically being undertaken only by surgeons on patients with penetrating chest trauma with profound shock or recently lost vital signs. When it is performed in these circumstances in the hope of restoring life, the procedure is outside the terms of this debate. Endotracheal intubation is a lifesaving procedure. The need for certain clinicians to be skilled in the technique is unequivocal, but at present there is no adequate animal model or manikin that can satisfactorily substitute for training in the skill; it can be gained only on human subjects with typical neck tissue resilience (that is, the newly deceased or patients anaesthetised for surgery). 1 It is self-evident that the former cannot be harmed, while the latter, even with the closest supervision, may potentially suffer from any of the complications of the procedure. It is pertinent to note that the need for clinical training in resuscitation techniques, its benefit to society and the educational value of practice on the newly deceased have not been seriously questioned in the medical literature. However, legal and ethical issues will inevitably arise. If law reports are any guide, this issue is not one of great public, judicial or coronial concern. In Australia, and even in the litigious United States, I have been unable to find a single successful criminal or civil prosecution of a doctor or hospital for permitting or performing a minimally invasive resuscitation technique on a newly deceased person. In Australia, coroners in several jurisdictions have raised no objection to the practice, provided such events are noted in the patient record. In both law and ethics, consent for clinical interventions is central to most arguments. If an advance directive has been made and is known, the situation is clear, but this circumstance is rare. Typically, death has been sudden and unexpected and relatives are often not available for some time. Obtaining consent from relatives is therefore frequently impractical, and indeed it has been suggested that, because of the additional stress and psychological harm that might result, it may be unethical to seek consent to procedures from relatives just confronted with the sudden death of a loved one. The literature provides little guidance in the analysis of this debate, but Bratteb¿ et al. showed, in a random public survey in Norway, that 70% of people would consent to being used for teaching intubation during anaesthesia and 60% would consent to the procedure being performed on a newly deceased relative.2 In this study, only four of 971 respondents considered these practices "unethical". Most other published studies on this subject have reported similar results, but the views of Australian society have never been surveyed and extrapolation of information from other cultures and legal systems may be inappropriate. Our society needs to consider three possible options if it believes that there is a benefit to having doctors skilled in resuscitation. The first is to create a requirement for explicit proxy consent from the next of kin. This would be frequently impractical, might cause psychological distress for some people, and might not represent a true substituted judgement of the deceased. The second option is for the States and Territories to legislate to sanction a range of procedures on the basis of presumed consent. Here, society would be agreeing, through its elected representatives, that the net benefit of the educational practice is significant, and would assume that its members wish to act beneficently in death. At least 15 countries currently have presumed-consent laws. The final option is to maintain the status quo, but with more explicit arrangements. For this option, institutional guidelines and review of practice are mandatory. The public must be assured that the deceased will always be treated with respect and that their known wishes will be followed. The procedures practised on the deceased should be those required to save lives in emergency situations, and should be conducted in a defined educational program by medical or paramedical personnel under specialist supervision. The supervisor should be responsible for the sensitive and appropriate selection of both clinical material and procedure, having regard to such matters as the circumstances of death, any religious considerations, forensic relevance and the voluntarily expressed views of any relatives or staff present. Informed consent from the senior available next of kin should be obtained for any procedure to be performed after the deceased has been removed from the resuscitation area. Proxy consent would not need to be obtained for the performance of minimally invasive procedures undertaken in accordance with institutional guidelines in the immediate postresuscitation period. Also, the supervisor would not need to specifically inform relatives unless directly questioned, but all procedures should be recorded in the patient record, and these should be routinely reviewed for appropriateness as part of clinical audit and quality management processes. Teaching resuscitation on the newly deceased is an important educational tool in medicine, but there are complex social issues involved. It is therefore inappropriate and unnecessary for the practice to be hidden from public scrutiny and debate. It is equally inappropriate for the practice to occur other than in the context of strict institutional guidelines and review. This is a matter which could be addressed by many Australian hospitals immediately. Richard AshbyDirector, Department of Emergency Medicine Royal Brisbane Hospital, Brisbane, QLD Orlowski JP, Kanoli GA, Mehlman MJ. The ethics of using newly dead patients for teaching and practising intubation techniques. N Engl J Med 1988; 319: 439-441. Brattebo G, Wisberg T, Solheim K, Oyen N. Public opinion on different approaches to teaching intubation techniques. BMJ 1993; 307: 1256-1257.

Richard Ashby

Major depression and refusal of life-sustaining medical treatment in the elderly Stuart C Hooper, Kevin J Vaughan, Christopher C Tennant and Janette M Perz MJA 1996; 165: 416-419 Abstract - Introduction - Methods - Patients and assessment - Follow-up - Statistical analyses - Results - Patients - Intensity of depression - Desire for life-sustaining treatment - Discussion - Acknowledgements - References - Authors' details Abstract Objective: To examine the effect of improvement or recovery from major depression in elderly patients on their desire for life-sustaining treatments. Design: Prospective case survey. Setting: Psychogeriatric Service of Hornsby Ku-ring-gai Hospital & Community Health Services and Ryde Hospital & Community Health Services (a community-based service serving an urban population with over 29 000 elderly people). Subjects: All patients referred with major depression (diagnosed by DSM-IV criteria) and no significant cognitive impairment between October 1994 and January 1995. Outcome measures: Number of life-sustaining treatments desired before and after treatment of depression in two hypothetical acute life-threatening illnesses (one with a good and the other with an uncertain prognosis), and intensity of depression on the Geriatric Depression Scale (GDS). Results: 22 subjects completed both stages of the study. Initial depression was severe in five, moderate in 16 and mild in one. GDS scores decreased in 18 subjects after treatment. Mean number of life-sustaining treatments desired by these patients increased significantly from 4.0 to 6.1 (out of seven possible treatments) in the "good prognosis" illness and from 6.4 to to 9.6 (out of 14) overall. The increase in the "uncertain prognosis" illness (2.3 to 3.4) was not significant. Conclusions: Moderate or severe major depression in the elderly is associated with a high degree of refusal of life-sustaining treatments. Treatment of the depression leads to increased acceptance of these treatments, particularly if prognosis is good. MJA 1996; 165: 416-419 Introduction Decisions about withdrawing or withholding life-sustaining medical treatments have become problematic in recent decades. Dramatic advances in medical technology enable many severely ill patients to remain alive, yet the decision to prolong life is tempered by the finite nature of resources, economic rationalism and the patient's quality of life. In the United States, it is estimated that decisions to limit medical treatment are made for about 70% of patients who die in hospital.1 In many cases, this is due to patient refusal of further medical treatment and is part of the strong shift towards respecting patients' autonomy and right to self-determination. In all Australian States, there is a common-law right for competent patients to refuse medical treatment, including life-sustaining treatment. In Victoria, South Australia and the Northern Territory, this right has received statutory recognition. In these States, legislation also permits competent individuals over 18 years to make advance directives ("living wills") specifying that in the event of a terminal illness the individual does not wish to be subjected to extraordinary life-prolonging measures.2 However, the potential influence of depressive illness on patients' refusal of life-sustaining treatment is often neglected. In the elderly (who are disproportionately represented among those who have life-sustaining treatment withheld or withdrawn), depression is often not recognised by primary care physicians.3-7 Misdiagnosis is especially likely in the elderly if symptoms are atypical (e.g., cognitive deficits [pseudo dementia], somatisation or anxiety). Further, with depression impairments in decision-making may be under-recognised, as the cognitive aspects of competence (which are emphasised by doctors and courts) may remain intact, while more subtle abilities (such as the ability to assign realistic values or meanings to the risks and benefits of prospective treatments)8,9 may be impaired. Depressed patients may undervalue potential positive outcomes and predict negative outcomes.9 These "affective" aspects of clinical competence are generally not considered as important as the "cognitive" aspects and can be more difficult to detect.10 The negative outlook disappears after recovery from depression, suggesting that it is specific to the illness phase and not a trait of depression-prone individuals.11,12 Case reports have highlighted patients who have initially refused, but later accepted, life-sustaining treatment after recovery from depression.9,15-18 Longitudinal studies of male Veterans Administration patients in the United States found that desire for life-sustaining treatment was not increased by recovery from major depression of mild to moderate severity,13,14 but was significantly increased if the major depression was severe.14 However, the extent to which results of these case reports and longitudinal studies can be generalised is uncertain. We therefore investigated the effect of recovery from major depression on preferences for life-sustaining treatments in a group of patients referred to an Australian community psychogeriatric service. Methods Our study was approved by the Ethics Committee of the Hornsby Ku-ring-gai Hospital & Community Health Services and Ryde Hospital & Community Health Services. Patients and assessment Subjects for the study were drawn from consecutive patients referred to the Psychogeriatric Service of Hornsby Ku-ring-gai Hospital between October 1994 and January 1995. The Psycho geriatric Service is a community-based service with inpatient facilities, serving an area with over 29 000 elderly people. Inclusion criteria: Diagnosis of DSM-IV major depression,19 made by clinical interview with the consultant psychiatrist and senior psychiatric registrar of the Psychogeriatric Service, according to DSM-IV criteria (Box 1). Severity of depression (mild, moderate, severe) was also assessed clinically with DSM-IV criteria; Mini-Mental State Examination score (MMSE) > 17.20 This was used to screen out patients with significant cognitive impairment; and Informed consent given. Intensity of depression was assessed with the Geriatric Depression Scale (GDS). This is a rating scale (not a diagnostic instrument) that provides a numerical index of intensity of depression and was designed exclusively for use in elderly patients. It contains 30 questions requiring a yes or no answer, which can be either self- or observer-administered. One-week test-retest reliability of 0.85 and criterion validity of 0.82 have been recorded.21,22 Desire for life-sustaining treatment was assessed by a questionnaire adapted from Lee and Ganzini,13 with simplification of the hypothetical scenarios. Patients were asked to "imagine that you developed a sudden life-threatening illness with an uncertain chance of recovery". They were then asked, "Would you want the following procedures should they be needed?". These comprised intravenous fluids with medication, nasogastric tube, blood transfusions, intensive care, kidney dialysis, mechanical ventilatory support, and cardiopulmonary resuscitation. The question was repeated for a similar illness with a good chance of complete recovery. Desire for life-sustaining treatment was quantified by assigning a point for each treatment desired. Follow-up After standard treatment for major depression (including pharmacological agents in all cases and electroconvulsive therapy in two), clinical assessments, GDS and questionnaires were repeated. At least six weeks was allowed before follow-up as the elderly may take longer to respond to antidepressant treatment. Recovery (remission) from major depression was diagnosed clinically at follow-up interview if patients no longer met the DSM-IV criteria for major depression. Statistical analyses The paired t test was used to compare initial and follow-up GDS scores. The Wilcoxon signed-rank test (a non-parametric test) was used to compare initial and follow-up scores for the life-sustaining treatment questionnaire, scoring 1 for any increase and 0 for any decrease and ignoring patients who did not change. The binomial distribution was consulted, with parameters 0.5 and the number of people who changed preferences. Results Patients Of 25 consecutive patients referred with major depression to the Psychogeriatric Service during the study period, 22 were included in the study. Two failed to meet the inclusion criteria (one did not give informed consent and the other did not score sufficiently on the MMSE) and a third died before follow-up. Demographic characteristics of the 22 who completed the study are shown in Box 2. A notable feature was the very high proportion of women in the group (82%). All but four of the patients were new referrals to the service and 10 (46%) were reporting their first depressive disorder. None had a history of previous prolonged psychiatric hospitalisations or previous suicide attempts. Twelve patients (55%) were treated in their homes, eight (36%) were treated predominantly in an inpatient psychiatric unit and two (9%) predominantly in a medical ward. Follow-up after a mean of 88.5 days (SD, 26.3) showed no significant changes in the number of medical illnesses or in demographic variables. Intensity of depression Severity of the depression was classed as moderate for 16 patients (73%), severe for five (23%) and mild for one (5%). Mean GDS score for the group was 24.4 (SD, 3.3) and decreased significantly on follow-up to 16.7 (SD, 8.0) ( P < 0.0005). Individual GDS scores decreased ("improved") in 18 patients, and 12 of these (55% of the total number) were diagnosed clinically as recovered from major depression, according to DSM-IV criteria. Desire for life-sustaining treatment Changes in desire for life-sustaining treatment among those whose depression improved or recovered are shown in Box 3. There were significant increases in the number of interventions desired overall and for the "good prognosis" illness among both the 12 patients who recovered from depression (according to DSM-IV criteria for remission) and the 18 whose GDS scores improved (including six who were not classed as recovered by DSM-IV criteria). There were also increases in the number of interventions desired for the "uncertain prognosis" illness, but the change was significant only in the "recovered" group. Of the 12 patients who recovered, nine had had major depression of moderate severity. The number of interventions desired among these nine also increased significantly overall ( P = 0.05) and for the "good prognosis" illness ( P = 0.04), but not for the "uncertain prognosis" illness. Discussion We found that remission of major depression in the elderly was associated with a significant increase in acceptance of life-sustaining treatments. This increase occurred for both moderate and severe forms of major depression. However, our study has limitations which should caution against drawing firm general conclusions. The main limitations are the relatively small sample size and the possibility of a gender bias caused by the high proportion of female patients. We also do not know the correlation between responses to hypothetical questionnaires and actual decisions when confronted with an "end of life" situation. However, indicating preferences to hypothetical scenarios is similar to executing a "living will" (also, in effect, hypothetical). The hypothetical scenarios examined only acute, not chronic, illnesses, and the findings of this study cannot necessarily be generalised to patients who have coexisting life-threatening medical conditions. In addition, the word "uncertain", used to describe prognosis in one of the scenarios, may have been ambiguous, as all prognoses are uncertain. It was chosen to enable comparison with Lee and Ganzini's studies,13,14 but "poor" or "unfavourable" would have been less ambiguous. A further limitation involved the diagnostic assessments, which did not use structured diagnostic instruments. Our results vary from those of other longitudinal studies.13,14 Ganzini et al.14 found that recovery from major depression was associated with change in preferences for life-sustaining treatments only if the depression was severe. Lee and Ganzini13,14 concluded that, in major depression of mild to moderate severity, "patients should not be discouraged from completing advance treatment directives and that choices by these patients to limit treatment should be respected". However, our finding of a significant increase in the number of life-sustaining treatments desired by nine patients who recovered from major depression of moderate severity suggests that doctors should be cautious about adopting such an approach in the elderly with moderate major depression. Differences between the results of our study and those of Ganzini et al.14 may have been caused by differences between samples and methods. Their sample had a higher proportion of men (81% versus 18% in our study) and their questionnaire about life-sustaining treatments was more complex, possibly affecting subject comprehension and reducing the sensitivity of the instrument. They used DSM-III-R criteria to diagnose major depression, but the differences between these criteria and the DSM-IV criteria that we used are minor. However, neither set of criteria precisely defines the boundaries between mild, moderate and severe forms of major depression, allowing the possibility of diagnostic bias in classifying severity. Further, in analysing their data, Ganzini et al.14 defined a clinically evident increase in preference for medical therapy as an increase in desire for a mean of three or more of the 14 possible interventions. A different cut-off (e.g., two or more of the 14 interventions) would have led to different results. In addition, we allowed a longer time before follow-up than Ganzini et al.14 (mean, 88.5 days versus 24.5 days), and, although we found that degree of recovery measured by GDS was no greater, it is possible that preferences for life-sustaining treatments may take longer to improve than depression. Another possibility is that the longer follow-up period in our study allowed factors other than changes in level of depression to affect preferences. These studies highlight the potential for depression to influence patient desire for life-sustaining treatments, suggesting that clinicians would be wise to take into account patients' mental state when assessing refusal of life-sustaining treatments. If doubt exists about a patient's decisional capacity, or whether major depression is present, psychiatric consultation is indicated. In the absence of an advance directive (completed before the onset of depression), severely depressed patients' wishes to forgo life-sustaining treatments should not be respected until an attempt is made to treat the depression. In contrast, it appears reasonable to respect the wishes of mildly depressed patients, whereas in moderate major depression consensus is lacking. It would be prudent (until further studies clarify this question) to err on the side of preserving life and to treat moderate major depression of moderate severity before respecting a refusal of life-sustaining treatments. Furthermore, patients with moderate or severe major depression who are planning to write advance directives should be encouraged not to do so until their depression has been treated. In our patients whose depression "improved", we found no significant increase in number of life-sustaining treatments desired for an illness with uncertain prognosis. Although the lack of significance may have been due to the small sample size, it suggests that the prognosis of the illness should also be considered in clinical settings. When prognosis is so poor that treatment becomes futile, refusal of life-sustaining treatments should be respected regardless of the presence of major depression, in accord with the ethical and legal principle that doctors are not required to administer futile treatments. The ethical dilemma presented by a depressed patient with dubious decisional capacity who refuses life-sustaining treatments has received little attention. The physician who complies faces the prospect that the patient's decision was biased by the depression and would have reversed on recovery. The physician who does not comply faces the possibility that the request was authentic and the patient's life has been prolonged against his or her wishes. In resolving the dilemma, careful consideration should be given to the severity of the depression, the prognosis of the illness and whether treatment would be deemed futile, and also to any previous directives made by the patient when their decisional capacity was clearly intact. Acknowledgements We acknowledge the generous support of Dr R Russell (Psychogeriatrician, Royal North Shore Hospital), and Dr W Jenneke (Staff Specialist Psychiatrist, Hornsby Ku-ring-gai Hospital). References Greco P, Shulman K, Lavizzo-Mourey R. The patient self-determination Act and the future of advance directives. Ann Intern Med 1991; 115: 639-643. CCH Australia. Death with dignity. Australian Health and Medical Law Reporter. Sydney: CCH Australia Ltd, 1995: paragraph 22-360. Regier D, Hirschfeld R, Goodwin F. The NIMH depression awareness, recognition, treatment program. Am J Psychiatry 1988; 145: 1351-1357. NIH Consensus Development Panel on Depression in Late Life. Diagnosis and treatment of depression in late life. JAMA 1992; 268: 1018-1024. Eisenberg L. Treating depression and anxiety in primary care -- closing the gap between knowledge and practice. N Engl J Med 1992; 16: 1080-1084. Nielson C, Williams T. Depression in ambulatory medical patients: prevalence by self report questionnaire and recognition by nonpsychiatric physicians. Arch Gen Psychiatry 1980; 37: 999-1004. Rapp S, Walsh D, Parisi S. Detecting depression in elderly medical inpatients. J Consult Clin Psychol 1988; 56: 509-513. Appelbaum P, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1988; 319: 1635-1638. Gutheil T, Bursztajn H. Clinicians' guidelines for assessing and presenting subtle forms of patient incompetence in legal settings. Am J Psychiatry 1986; 143: 1020-1023. Bursztajn HJ, Harding HP, Gutheil TG, Brodsky A. Beyond cognition: the role of disordered affective states in impairing competence to consent to treatment. Bull Am Acad Psychiatry Law 1991; 19: 383-388. Chochinov HM, Wilson KG, Enns M, et al. Desire for death in the terminally ill. Am J Psychiatry 1995; 152: 1185-1191. Wilkinson IM, Blackburn I. Cognitive style in depressed and recovered depressed patients. Br J Clin Psychol 1981; 20: 283-292. Lee M, Ganzini L. The effect of recovery from depression on preferences for life-sustaining therapy in older patients. J Gerontol 1994; 49: M15-M21. Ganzini L, Lee M, Heintz R, et al. The effect of depression treatment on elderly patients' preferences for life-sustaining medical therapy. Am J Psychiatry 1994; 151: 1631-1636. Salzman C. ECT and ethical psychiatry. Am J Psychiatry 1977; 134: 1006-1009. Weitzel W, Purtilo R. Aggressive treatment of geriatric depression: what limits on intervention? Psychiatr Opin 1979; 160: 9-14. Swartz C, Stewart C. Melancholia and orders to restrict resuscitation. Hosp Community Psychiatry 1991; 42: 189-191. Baile F, DiMaggio J, Schapira D. The request for assistance in dying. Cancer 1993; 72: 2786-2791. American Psychiatric Association diagnostic and statistical manual of mental disorders (DSM-IV). 4th ed. Washington DC: APA, 1994. Folstein M, Folstein S, McHugh P. "Mini-Mental State": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189-198. Yesavage J, Brink T, Rose T. Development and validation of a geriatric depression screening scale: a preliminary result. J Psychiatr Res 1983; 17: 37-49. Koenig HG, Meador KG, Cohen HF, Blazer DG. Self-rated depression scales and screening for major depression in older hospitalized patient with medical illness. J Am Geriatr Soc 1988; 36: 699-796. (Received 30 Oct 1995, accepted 3 Jun 1996) Authors' details Department of Mental Health, Hornsby Ku-Ring-Gai Hospital, Sydney, NSW. Stuart C Hooper, FRANZCP, Senior Psychiatric Registrar in Psychogeriatrics; now Consultant Psychiatrist, Sydney, NSW; Kevin J Vaughan, FRANZCP, Staff Specialist. Department of Academic Psychiatry, Royal North Shore Hospital, Sydney, NSW. Christopher C Tennant, FRANZCP, MD, Professor. Department of Psychology, Faculty of Arts and Social Sciences, University of Western Sydney, NSW. Janette M Perz, BA(Hons), Research Psychologist. No reprints will be available. Correspondence: Dr S C Hooper, 11 Clanalpine Street, Eastwood, NSW 2122.

Stuart C Hooper · Kevin J Vaughan · Christoper C Tennant · Janette M Perz

Teaching resuscitation skills using the newly deceased Corinne Ginifer and Anne-Maree Kelly In many hospital emergency departments doctors learn life-saving technical skills on patients who have recently died. This longstanding practice is justified as providing training that cannot be offered in any other way. But can it continue without the informed consent of relatives and the general approval of the public? (MJA 1996; 165: 445-447) For editorial comment, see Ashby Introduction - The overseas experience - The Australasian experience - Ethics - Law - Public debate - References - Authors' details Introduction Patients today are educated, informed and active in decisions concerning their health. Much of the awe and mystery that once surrounded the practices of doctors has been dispelled and some longstanding practices are now being questioned. One such practice is the use of the bodies of newly deceased patients to train staff in specialised emergency procedures, a practice that has been criticised on ethical, religious and legal grounds.1 Aside from these arguments, it may be argued that the practice is outdated, as there are now alternative teaching tools -- but do the alternatives offer the same quality of training? The overseas experience Reports from the United States suggest that the practice is widespread, occurring in up to 39% of hospitals.2 It is considerably more common within certain departments, occurring in 54%-63% of emergency departments and 58% of neonatal critical care programs,2,3 with nearly equal rates in both teaching and non-teaching hospitals.3 Few departments (only 7% in the United States) 3 have a written policy regarding the practice. Less than half of these policies required notification of the next of kin. None the less, reports indicate that in 10% of cases where recently deceased patients were used for this purpose consent was obtained. 2 Endotracheal intubation is the most commonly practised procedure. Other procedures include placement of central venous catheters, surgical venous cutdown, thoracotomy, pericardiocentesis, cricothyrotomy, liver biopsy and intraosseous needle placement. 2 Although there is widespread agreement (even in hospitals that do not teach using recently deceased patients) that the practice has educational value, objections on religious, ethical and legal grounds have been raised in up to 25% of institutions where it is practised. 3 Many members of staff, particularly nurses, find the practice distressing because it appears to conflict with their primary duty of care -- not only to the patient now deceased, but also to the relatives, whom they wish to protect from any further grief. Approaching relatives for consent to perform certain procedures on the recently deceased patient has been an issue much discussed. Many believe that relatives should not be approached for such consent as this would only cause them further distress. 4 However, a Norwegian study found that 58% of people surveyed would allow the body of a close relative to be used for teaching intubation techniques, 5 and a US study found that 39% of families consented to cricothyrotomy on deceased relatives. 6 Success rates for obtaining consent have been reported to be as high as 59% for invasive procedures in adults 7 and 73% for endotracheal intubation in deceased infants. 8 Success in obtaining consent depends upon providing adequate information and explanation to relatives and the opportunity to establish a relationship with the family before the patient's death. 6 The Australasian experience Our search of the Australasian literature ( Medline search using the keywords "newly", "deceased", "teaching" and "resuscitation", limited to the last 10 years) did not find any discussion of this issue, although we thought it likely that the practice is as common in Australia and New Zealand as it is overseas. In April 1995 we surveyed all 55 emergency departments in Australia and New Zealand accredited for training by the Australasian College for Emergency Medicine. The survey asked whether the department used the newly deceased to teach resuscitation skills and, if so, how frequently this practice occurred, which procedures were performed, whether consent was obtained from relatives of the deceased and whether the department had a policy about the practice. Respondents were invited to express their opinions on the legal, social and ethical issues involved. Forty-eight responses were received (response rate, 87%). Twenty-two respondents (46%) indicated that resuscitation skills were taught using the bodies of newly deceased patients in their emergency department. These data are comparable with those reported in the United States. 2,3 Further similarities exist: no department which practised such procedures obtained consent from relatives and only one of the 48 respondents had a written policy governing the practice. The procedures undertaken and their frequency are summarised in the Box. Concerns centred largely on legal and ethical issues, although 73% of respondents believed the practice to be ethical. Ethics The ethics of this practice have been debated in the international literature.1,4,9,10 The central issue is whether the need for training and the benefits resulting from access to the bodies of the recently deceased outweigh any possible harm to individuals and society. The need for highly trained doctors skilled in resuscitation techniques is undisputed. To produce such doctors there must be the means to teach resuscitation skills in a realistic manner. For many years, this was accomplished using recently deceased patients, upon whom an experienced member of staff demonstrated and taught junior members and medical students. Generally, the relatives of the deceased were not informed and, on the whole, only non-invasive procedures were undertaken. Such teaching involved only a few students at a time and was carried out in a sensitive manner with respect for the deceased. It did not present any risk of harm to the deceased while offering an educational opportunity without risks to living patients. However, it may be difficult to justify the use of recently deceased bodies for training if new teaching models and techniques are accepted as adequate alternatives. Sophisticated and realistic manikins can provide practice in endotracheal intubation, venous cannulation, external cardiac compression and so forth. Intubation experience may be gained using patients who are anaesthetised for surgery. Preserved cadavers and anaesthetised animals have also been used to teach various procedural skills. More recently, interactive videodisc instruction has gained recognition as a suitable tool for teaching endotracheal intubation. 3 Whether these alternatives are adequate remains contentious. The British Medical Association and the Royal College of Nursing, while adamantly rejecting the routine use of recently deceased patients for teaching purposes, do accept that it may be acceptable in exceptional circumstances when patients have suffered major trauma resulting in a disturbance to the normal anatomy of the face, neck and upper trunk: "Practising intubation on recently deceased patients who have suffered such injuries affords experience not obtainable in any other way." 11 This position suggests that, in general, the use of recently deceased patients in training can be justified if it is superior to the alternatives available. If so, then perhaps the "harm" we inflict can be justified for the "greater good" to society gained from such access. Would this practice be more acceptable if the consent of relatives was sought? Seeking consent may inflict further grief on those who are already distressed, but this may be the price we pay for the opportunity to access this valuable resource for teaching purposes. Law Laws regarding this practice differ around the world. Burns et al. have reviewed the relevant legislation and test cases in the United States, 2 where there are no state statutes that specifically prohibit the teaching of procedures using recently deceased patients. It has been established by various state courts that the patient's constitutional right to privacy that protects him or her from non-consensual invasion of the body terminates at the time of death. In addition, state courts in Michigan, Georgia and Florida hold that the constitutional rights to privacy and property are personal and cannot be claimed by the next of kin. In contrast, the US Appeals Court for the Sixth Circuit held that the next of kin had a constitutionally protected property interest in the patient's remains. Furthermore, the next of kin could have a legal claim against the hospital for negligent or intentional infliction of emotional distress if procedures were performed on the patient after death without the family's consent. Some countries (including Belgium, France and Israel) have adopted a "presumed consent" policy for organ donation. 2,9,10 This places the onus on the family to raise objection to organ donation; in the absence of specific objection, and with no obligation on the doctor to ask for permission, organ donation may proceed. In these countries the number of kidney transplants is well ahead of many other European countries and no one would doubt the benefits to society. Possibly, the same principle could be applied to the use of newly dead bodies for teaching purposes. What are the Australian laws on these matters? Currently, the coroners and human tissue Acts of the various Australian States do not deal specifically with this issue. Neither do the equivalent New Zealand Acts. There is no doubt that it is unlawful to interfere with coroner's cases, but there is no law preventing the use of bodies to teach minimally invasive and non-invasive procedures during the first few minutes after death in cases that are not required to be reported to the coroner. In Western Australia this may soon change. A new Coroners Act has recently been passed in the Lower House and is now before the Upper House of Parliament. This new Act deals specifically with the use of newly deceased patients for teaching purposes, requiring consent from the coroner together with either prior written permission from the deceased or permission from the senior next of kin in the absence of prior objection from the deceased. Other Australian States may follow suit. It is possible that the performance of such procedures could be considered a trespass under tort law, the principle being that people "should . . . be prevented from touching corpses whether by way of an unauthorized post-mortem examination or for other purposes". 12 This has not been tested in the Australian courts (Dr H Aders, legal adviser to the Medical Defence Union, Sydney, personal communication). Public debate Does the need for training and the benefits arising from access to the bodies of the recently deceased outweigh any possible harm to individuals and society? Progress in the debate has been slow, perhaps because of a reluctance to seek guidance from the community about a practice that has been occurring covertly for many years. References Iserson KV. Postmortem procedures in the emergency department: using the recently dead to practise and teach. J Clin Ethics 1993; 19: 92-98. Burns JP, Reardon FE, Truog RD. Sounding board: Using newly deceased patients to teach resuscitation procedures. N Engl J Med 1994; 331: 1652-1655. Morhaim DK, Heller MB. The practice of teaching endotracheal intubation on recently deceased patients. J Emerg Med 1991; 9: 515-518. Orlowski JP, Kanoti GA, Mehlman MJ. The ethical dilemma of permitting the teaching and perfecting of resuscitation techniques on recently expired patients. J Clin Ethics 1990; 1: 201-205. Brattebo G, Wisborg T. Teaching procedures on the newly dead [letter]. Ann Emerg Med 1995; 26: 242. Olsen J, Spilger S, Windisch T. Feasibility of obtaining family consent for teaching cricothyrotomy on the newly dead in the emergency department. Ann Emerg Med 1995; 25: 660-665. McNamara RM, Monti S, Kelly JJ. Requesting consent for an invasive procedure in newly deceased adults. JAMA 1995; 273: 310-312. Fernandes CMB. Practice of procedures on the newly dead [letter]. Ann Emerg Med 1995; 26: 1. Iserson KV. Law versus life: the ethical imperative to practice and teach using the newly dead emergency department patient. Ann Emerg Med 1995; 25: 91-94. Goldblatt AD. Don't ask, don't tell: practicing minimally invasive resuscitation techniques on the newly dead. Ann Emerg Med 1995; 25: 86-90. Royal College of Nursing. Intubation training: An ethical practice? Nursing Standard 1993; 7: 38-39. Trindade F, Cane P. The law of torts in Australia. 2nd ed. Melbourne: Oxford University Press, 1993. Authors' details Western Hospital, Melbourne, VIC. Corinne Ginifer, MB BS, DA(UK), DipRACOG, Emergency Medicine Registrar; Anne-Maree Kelly, FACEM, Staff Specialist, Emergency Medicine. No reprints will be available. Correspondence: Dr C Ginifer, Emergency Department, Western Hospital, Footscray, VIC 3011.

Corinne Ginnifer · Anne-Maree Kelly

Congenital syphilis: still a reality in 1996 Michael D Humphrey and David L Bradford MJA 1996; 165: 382 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Introduction - What is the true incidence of congenital syphilis in Australia? - Diagnosis - Risk factors for congenital syphilis - Measures to control syphilis - Problems in targeting those at risk - Action plan - Acknowledgements - References - Authors' details - - ©MJA1996 Despite the widespread use of penicillin for more than 50 years, syphilis continues to be a problematic health issue in many parts of the world. In Australia, congenital syphilis is again a significant cause of stillbirth, preterm labour and neonatal disease in some areas (including central and northern Australia). Control mechanisms based on screening, reliable treatment protocols, contact-tracing and adequate follow-up appear to be less effective than they were in the past. It is difficult to discuss such a socially stigmatising disease when it is clear that some community groups are at high risk, and may be offended by and feel disempowered in the face of well-meaning medical debate. If congenital syphilis is to be eradicated, new approaches are required. These include public-awareness campaigns to stress the need for antenatal care in affected communities; involving the community in efforts to prevent syphilis; providing culturally appropriate services; improving notification and surveillance systems; improving the management of pregnant women who present to maternity units without prior booking; and improving the management of syphilis in pregnancy. There is a need to raise awareness that antenatal care is important not only for the mother's health but also for the wellbeing of the baby. (MJA 1996; 165: 382-385) Introduction I n the last decade, much of the world has experienced a marked increase in the incidence of syphilis, with rates in reproductive-age adults the highest since the 1940s. 1 In Australia, notifications of syphilis between 1991 and 1994 varied from 12.2 to 16.0 per 100 000 population. 2 There was wide geographical variance, with reported rates greater than 100 per 100 000 in much of northern Australia; however, all States and Territories were involved (Box 1). The incidence was much higher in females than in males in the 10 to 24 years age group, and rates in Aboriginal people varied from 114 to 913 per 100 000 in different regions. 2 Elsewhere in the world, incidences similar to those in Australia are being reported, with particular emphasis on the high incidence of new and repeated infections in marginalised groups. 1,3-9 In regions where the prevalence of syphilis is high, congenital syphilis is a major preventable cause of perinatal death. 1,8,10,11 In 1994 and 1995, 232 new or repeated infections were notified in women from Cairns and the surrounding region involving Cape York and the Torres Strait (D Brookes, Public Health Nurse, Tropical Public Health Unit, Northern Zone, Queensland Health Department, Cairns, personal communication). Twenty-seven of the 3058 women who gave birth at Cairns Base Hospital during this period had active syphilis complicating their pregnancy (Tropical Public Health Unit, Northern Zone, Queensland Health Department, Cairns [unpublished data]), and eight of the region's 91 perinatal deaths were judged to be due to congenital syphilis in association with inadequate antenatal care (Cairns Base Hospital Perinatal Mortality Committee [unpublished data]). The main features of untreated congenital syphilis during pregnancy are stillbirth (which may be preceded by non-immune hydrops fetalis), preterm labour and intrauterine growth restriction; in the newborn the main features are hepatosplenomegaly, prolonged jaundice, thrombocytopenia, failure to thrive and radiologically visible metaphyseal changes. To prevent congenital syphilis, institutional, administrative and cultural barriers to the successful management of the problem must be overcome. The true incidence of syphilis must be determined, diagnostic procedures improved, the risk factors more readily recognised and control measures re-examined. What is the true incidence of congenital syphilis in Australia? The accurate diagnosis of syphilis depends on the microbiological demonstration of Treponema pallidum . Serological tests provide indirect evidence of infection, and, without clinical assessment, are crude indicators of whether infection is likely to be recent or long-standing. Nevertheless, in many jurisdictions in Australia case reporting of syphilis is dependent on laboratory notification of positive syphilis serology. Thus, notification of syphilis is based on an arbitrary decision as to whether an infection is likely to be recent, as determined by the rapid plasma reagin (RPR) or Venereal Disease Research Laboratories (VDRL) titre. For example, in Queensland the case definition for notification is based on an RPR/VDRL titre of 1 : 8 or more, in association with positive specific treponemal serology. 12 Cases so notified are likely to be in individuals who have a recently acquired infection, and non-notification of lower titres may mean that there is a degree of under-reporting, particularly in the latent phase of the disease. No agreed definition of the criteria for reporting congenital syphilis exists in Australia, and only 13 cases have been reported nationally in the last five years, including two in women over 65 years of age (J Irvine, Surveillance Officer, Communicable Diseases Network of Australia and New Zealand -- National Notifiable Diseases Surveillance System, Canberra, personal communication). Thus, the true incidence of this problem nationwide is unknown. Diagnosis Definitive diagnosis is by trepo nemal-specific tests ( Treponema pallidum haemagglutination antibody [TPHA], fluorescent treponemal antibody [FTA]) when screening non-treponemal serological tests (RPR or VDRL) are positive, as pregnancy, HIV infection and other conditions (such as systemic lupus erythematosus, rheumatoid arthritis, infectious mononucleosis, and many other diseases associated with autoimmune complexes) can be associated with false positive screening reactions, or with difficulties in interpreting results. 13 Care must be taken to ensure that lack of familiarity with the codes used to express the results of syphilis serology does not lead to failure to recognise the disease and, consequently, failure to follow-up. 5 It is necessary to carefully follow-up all babies born to women who have positive serological tests for syphilis, as more than 50% of liveborn affected infants are asymptomatic. Failure to conduct such follow-up may lead to significant long term physical and/or mental handicap. Risk factors for congenital syphilis These risk factors include: Lack of adequate antenatal care; 8 Failure to repeat a serological test for syphilis in the third trimester when it tested negative at first booking; 8 Past history of sexually transmitted disease (STD); 8 Multiple sexual partners; 8 Substance abuse; 8 and Being in a displaced or marginalised population group (indigenous peoples, and people marginalised by chemical dependency, poverty, prostitution). 9 Vertical transmission usually takes place after four months' gestation, so that early antenatal screening and appropriate treatment should prevent most cases. It is clear that, if screening is not performed, the diagnosis is unlikely to be made in a timely fashion. Therefore, major efforts must be made in the future to alter the way we deliver antenatal care so that it is accessible and appropriate to those at high risk. Measures to control syphilis Guidelines for syphilis control, formulated almost 60 years ago in the United States, 14 included the principal elements of public education (including community participation), case-finding, prompt clinical treatment, contact-tracing and routine serological screening (including antenatal screening) of high-risk groups. The implementation of this program in the United States proved to be effective. However, in 1986 the incidence of early syphilis in the United States increased, 15 with a predictable increase in congenital syphilis accompanying this new epidemic. 16 By 1990, at the peak of the epidemic, African Americans accounted for more than 80% of reported cases of early syphilis. 17 A dramatic increase in the availability of "crack" cocaine (accompanied by an increase in the practice of exchanging sex for money and drugs), increasing poverty, disenfranchisement of minorities and urban decay were some of the reasons for this disproportionate incidence of syphilis in black communities in the United States. 17 The efficacy of control programs for sexually transmitted disease, and especially contact-tracing activities, employed to control this outbreak of syphilis in the United States was seriously questioned. 18 In Australia, we have sought to control syphilis by broadly following the same United States guidelines. In the major cities, where syphilis rates today are minimal, this has served us well. However, throughout northern Australia, as well as in northern Victoria, central Australia and northwest New South Wales, the prevalence of syphilis has remained high, despite our best efforts. Allan Brandt (Professor of the History of Medicine and Science, Harvard University), in No Magic Bullet , argues that a biomedical approach (e.g., case-finding, contact-tracing and treatment protocols) is too restrictive, and that social conditions and other variables need to be addressed. 19 While there will always be a place for contact-tracing the immediate partner(s) of index cases -- particularly of pregnant women with syphilis (as a control measure) -- this is less successful in practice than theory would suggest. Various factors, such as the time involved and the patient's embarrassment and reluctance to contribute to the program, make contact tracing difficult to conduct from the urban consulting room. However, in indigenous communities other factors, such as cultural sensitivity about the discussion of sexual issues outside the family or tribal group, beliefs in what constitutes "men's business" and "women's business" and the dilemma of finding health workers of the same sex and tribal group to conduct the tracing, pose additional difficulties. These factors, together with a relative dearth of male indigenous health workers, a rapid turnover of staff and the low priority placed on public health activities, result in often-insurmountable difficulties in implementing contact-tracing. In any case, many diagnoses of syphilis in adults in northern Australia are likely to represent latent rather than currently infectious disease, so th at even highly successful contact-tracing will have a relatively small impact on public health control of the disease. Problems in targeting those at risk A recent editorial in Sexually Transmitted Diseases notes that in the United States "syphilis is a marker for social marginalization" (i.e., the spread of the disease is disproportionate in poor members of minority groups). The authors state that: . . . Underlying the problem of syphilis in the United States, and central to any plans to eliminate it, are the issues of race, racism, and poverty, and our ability to speak frankly and intelligently about these issues. . . . It is from a legitimate fear of the consequences of the social stigma of syphilis that many community advocates prefer not to talk about racial differences in syphilis rates. . . . This hiding of the key fact about syphilis may be making it difficult for concerned persons to mobilise the kind of support needed for effective prevention programs. 1 We believe a "key fact" in Australia is that Aboriginal and Torres Strait Islander populations are disproportionately affected by syphilis, yet it is difficult to talk openly about this for fear of further marginalising or stigmatising indigenous people. This understandable sensitivity has tended to stifle productive debate about how we can best deal with the issue, and has hampered communication between affected communities and health professionals. The continuing high prevalence of syphilis in indigenous communities in Australia is a major threat to the welfare of unborn and newborn children. It is vital that those at most risk can be targeted for the provision of high quality antenatal care (if necessary, through special outreach programs); for retesting in the third trimester or at birth; 20,21 for the development of appropriate treatment protocols; and for contact-tracing that is realistic and achievable. Action plan It seems clear that we need a new approach if syphilis is to be controlled, and if congenital syphilis is to become (as it should be) a tragedy of the past. While accepting that the persistence of infectious syphilis (and the accompanying sporadic cases of congenital syphilis) in indigenous communities in Australia is a complex issue, we suggest some measures that could be considered in addressing the problem ( Box 2). We must find a way to discuss honestly and openly the continuing high prevalence of syphilis in indigenous communities, which is a major threat to the welfare of unborn and newborn children, so that those at most risk can get the most appropriate care. Acknowledgements We wish to thank Ms D Brookes, RN (Public Health Nurse, Tropical Public Health Unit, Northern Zone, Queensland Health Department, Cairns), Dr W J Smith (Cairns District Health Service) and the staff of the Communicable Diseases Network of Australia and New Zealand -- National Notifiable Diseases Surveillance System, Canberra, for their assistance. References St Louis ME, Farley TA, Aral SO. Untangling the persistence of syphilis in the south [editorial]. Sex Transm Dis 1996; 23: 1-4. Hargreaves J, Longbottom H, Myint H, et al. Annual Report of the National Notifiable Diseases Surveillance System, 1994. Commun Dis Intell 1995; 19: 542-574. Garland SM, Kelly VN. Is antenatal screening for syphilis worth while? Med J Aust 1989; 151: 368-372. How JHY, Bowditch JDP. Syphilis in pregnancy: experience from a rural aboriginal community. Aust N Z J Obstet Gynaecol 1994; 34: 383-389. Gurry DL, Porter PA, Evans DTP. Congenital syphilis: when the medium fails to transmit the message. Med J Aust 1993; 159: 121-124. Humphrey MD. Syphilis -- alive and well as a cause of perinatal death [letter]. Med J Aust 1996; 164: 381-382. Mascola L, Pelosi R, Blount JH, et al. Congenital syphilis. Why is it still occurring? JAMA 1984; 252: 1719-1722. Lim CT, Koh MT, Sivanesaratnam V. Early congenital syphilis -- a continuing problem in Malaysia. Med J Malaysia 1995; 50: 131-135. McFarlin BL, Bottoms SF, Dock BS, Isada NB. Epidemic syphilis: maternal factors associated with congenital infection. Am J Obstet Gynecol 1994; 170: 535-540. Duthie SJ, King PA, Yung GLK, Ma HK. Routine serological screening for syphilis during pregnancy -- disposable anachronism or fundamental necessity? Aust N Z J Obstet Gynaecol 1990; 30: 29-31. Klass PE, Brown ER, Pelton SI. The incidence of perinatal syphilis at the Boston City Hospital: a comparison across four decades. Pediatrics 1994; 94: 24-28. McCall B. Surveillance of sexually transmissible disease in Queensland 1988-1993. Commun Dis Intell 1995; 19: 58-68. Nandwani R, Evans DT. Are you sure it's syphilis? A review of false positive serology. Int J STD AIDS 1995; 6: 241-248. Parran T. Shadow on the land. New York: Reynal and Hitchcock, 1937. CDC. Primary and secondary syphilis -- United States, 1981-1990. MMWR Morb Mortal Wkly Rep 1991; 40: 314-315, 321-323. CDC. Surveillance for geographic and secular trends in congenital syphilis -- United States, 1983-1991. MMWR Morb Mortal Wkly Rep 1993; 42 (Suppl 6): 59-71. Nakashima AK, Rolfs RT, Flock ML, et al. Epidemiology of syphilis in the United States, 1941-1993. Sex Transm Dis 1996; 23: 16-23. Andrus JK, Fleming DW, Harger DR, et al. Partner notification: can it control epidemic syphilis? Ann Intern Med 1990; 112: 539-543. Brandt AM. No magic bullet: a social history of venereal disease in the United States since 1880. Expanded edition. New York: Oxford University Press, 1987: 4. Qolohle DC, Hoosen AA, Moodley J, et al. Serological screening for sexually transmitted infections in pregnancy: is there any value in re-screening for HIV and syphilis at the time of delivery? Genitourin Med 1995; 71: 65-67. Opai-tetteh ET, Hoosen AA, Moodley J. Re-screening for syphilis at the time of delivery in areas of high prevalence. S Afr Med J 1993; 83: 725-726. Metropolitan New York City Area Task Force on Syphilis. Report to the New York State Department of Health 1991: 1-16. Ernst AA, Romolo R, Nick T. Emergency department screening for syphilis in pregnant women without prenatal care. Ann Emerg Med 1993; 22: 781-785. Sanchez PJ, McCracken GH Jr, Wendel GD, et al. Molecular analysis of the fetal IgM response to Treponema pallidum antigens: implications for improved sero diagnosis of congenital syphilis. J Infect Dis 1989; 159: 508-517. Quinn TC. Recent advances in diagnosis of sexually transmitted diseases. Sex Transm Dis 1994; 21 (Suppl): S24. Authors details North Queensland Clinical School, The University of Queensland. Michael D Humphrey, FRACOG, Professor of Obstetrics and Gynaecology; and Director of Obstetrics and Gynaecology, Cairns Base Hospital, QLD. Cairns District Health Service, Cairns, QLD. David L Bradford, FACVen, Director of Sexual Health. No reprints will be available. Correspondence: Professor Michael D Humphrey, Department of Obstetrics and Gynaecology, Cairns Base Hospital, PO Box 902, Cairns, QLD 4870. - - To top of article - ©MJA1996 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Michael D Humphrey · David L Bradford