Issues

Volume 169 Issue 6

21 September 1998

Editorials Legal implications of clinical practice guidelines Peter Dwyer (MJA 1998; 169: 292-293)Retaining a medical workforce in rural Australia Ian Cameron (MJA 1998; 169: 293-294)Men's health R W Connell, Allan K Huggins (MJA 1998; 169: 295-296)Protozoa in drinking water: is legislation the best answer? Martha I Sinclair, Christopher K Fairley, Margaret E Hellard (MJA 1998; 169: 296-297)Excimer laser refractive surgery Grant R Snibson, Hugh R Taylor (MJA 1998; 169: 298-299) Research Surgeons' opinions about the NHMRC clinical practice guidelines for the management of early breast cancer Sue E Carrick, Billie Bonevski, Sally Redman, John Simpson, Rob W Sanson-Fisher, Fleur Webster (MJA 1998; 169: 300-305)Juvenile offenders and hepatitis B: risk, vaccine uptake and vaccination status Sandra C Thompson, Elaine L Ogilvie, Friederike C Veit, Nick Crofts (MJA 1998; 169: 306-309)Incidence of mastitis in breastfeeding women during the six months after delivery: a prospective cohort study Joanne R Kinlay, Dianne L O'Connell, Scott Kinlay (MJA 1998; 169: 310-312) Notable Cases Venous thrombosis and hyperhomocysteinaemia John W Eikelboom, Ross I Baker (MJA 1998; 169: 313-315) History Howard Florey Norman Heatley (MJA 1998; 169: 316-317) Medicine and the Community Staying in or leaving rural practice: 1996 outcomes of rural doctors' 1986 intentions Max Kamien (MJA 1998; 169: 318-321) Abstract - ArticleA profile of rural surgeons in Australia Martin H Bruening, Guy J Maddern (MJA 1998; 169: 324-326) Abstract - Article Viewpoint Qualitative research: a path to better healthcare Jennifer K Peat, Brett G Toelle, Sue A Nagy (MJA 1998; 169: 327-329) Medicine and the Law Clinical practice guidelines before the law: sword or shield? Janet E Pelly, Liza Newby, Fiona Tito, Sally Redman, Amanda M Adrian (MJA 1998; 169: 330-333) Matters Arising Doctors' working hours (MJA 1998; 169: 339-341)

Editorials

General medicine 15 September 1998 Free

Legal implications of clinical practice guidelines

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

General medicine 15 September 1998 Free

Retaining a medical workforce in rural Australia

Retaining a medical workforce in rural Australia Professional satisfaction is a major concern for rural doctors MJA 1998; 169: 293-294 For at least 10 years, the imbalance of general practitioners in rural and remote areas of Australia has been addressed by successive health policies and strategies. These activities are driven in large part by a desire for equity of access to and quality of medical care in our rural and remote communities. Seminal in the early considerations in attracting and maintaining a rural medical workforce were the reports by Kamien1 to the Western Australian and Shehadie2 to the New South Wales departments of health. Both reports disclosed a need for support for rural doctors, particularly in access to continuing medical education (CME) and provision of locums. These reports were instrumental in the formation, in 1988, of the NSW Rural Doctors Resource Network and, in 1990, of the Western Australian Centre for Rural and Remote Medicine. In 1993, the Commonwealth Department of Human Services and Health launched the General Practice Rural Incentives Program (GPRIP), which aimed to attract doctors through relocation, retraining and remote area grants, and to retain them by addressing access to CME and locum support. This issue of the Journal includes two reports which have implications for Australia's rural workforce. Bruening and Maddern3 disclose a profile of rural surgeons that is one of predominantly middle-aged men whose major concerns include continual on-call work, lack of locum relief, and peer isolation. Although the majority of surgeons intend to remain in rural practice until retirement, the ageing of our rural surgical workforce has obvious implications. Kamien4 provides unique information on why doctors stay in or leave rural practice by examining the major concerns and practice intentions of rural doctors in 1986 and their practice locations by 1996. Those doctors who remained in rural practice had successfully resolved their 1986 concerns; those who left had not. For the latter, unresolved concerns included access to CME, overwork, forced deskilling, and professional isolation. Kamien also highlights the major concerns which would influence doctors currently in rural practice to leave; these include problems in achieving professional satisfaction as pressures (such as hospital closures) on the provision of rural health services increase. The whole issue of retention of doctors in rural practice is attracting renewed attention and recently several researchers have addressed this issue. Hoyal has proposed that important influences in this are professional factors influencing the doctor, social and other factors affecting the doctor's family, and community influences.5 While listing a range of professional factors, he also highlighted the need for community backing for the local hospital as well as emotional, professional and financial hospital support for the doctor. In a survey of Queensland doctors who had recently left rural practice, Hays and colleagues6 found that these doctors emphasised the positive aspects of rural practice to be professional autonomy and support, community relationships, work variety, family lifestyle and continuity of care. The downside included after-hours workload, poor access to CME and locums, personality clashes, and lack of family educational opportunities. In proposing retention strategies, Hays et al developed a conceptual model of a balance between influences to stay or to leave, and triggers that could shift this balance. While acknowledging that personal (eg, personality clashes) and family (eg, children's education) triggers may be difficult to address, they proposed professional retention strategies that could be readily addressed. These include provision of CME, locum cover, management training for doctors, and educational packages for families. They also suggested that local support and early intervention structures could be developed through Divisions of General Practice. A recent consultancy to GPRIP has produced a discussion paper on models of sustainable practice in rural and remote Australia.7 The focus on "sustainable practice" instead of "retention" helps to highlight another element of focusing on a continuity of rural medical service. The discussion paper proposes that strategies for sustainability include those issues that promote sustainability of the individual doctor (including access to CME, locums, and family support), those that promote sustainability of the practice environment (including the relationship with the local health service provider), and those that promote sustainability of the community. It is evident that the strategies for practice sustainability are largely concentrated on the needs expressed by rural doctors over the past 10 years. In many States these have been coupled with rurally targeted financial support for services provided in public hospitals. The concept of a continuous workforce by readily available replacement of doctors has been taken up in the short term with relocation and retraining support by GPRIP, and in the longer term by early exposure of undergraduates to rural medicine and support for entrance to medical schools of students from a rural background. At the national level needs have also been identified. Those proposed in a discussion paper of the Australian Medical Association and the Rural Doctors' Association of Australia8 include a national medical workforce recruitment and retention scheme; a nationally consistent system of granting clinical privileges; continued and increasing refinement of postgraduate, vocational and continuing medical education; the introduction of retention payments and development of information technology; innovative practice structures; and Aboriginal health strategies. Some or all of these can be developed or implemented at State level. The new Rural Workforce Agencies and Divisions of General Practice are ideally placed to develop the strategies that allow both long term and emergency impact on the triggers for leaving rural practice. It would seem that a major task for the Rural Workforce Agencies and Rural Doctors Associations in each State will be to bring cohesion to retention strategies while promoting regional and local flexibility. While those support strategies that have been working must continue, the major challenge will be in promoting the autonomy and self-esteem of rural doctors that Kamien suggests. This will need to be done by negotiating with health service provider organisations and communities to develop strategies that allow doctors the professional satisfaction of providing their medical skills to those communities, thereby maximising the health status of rural Australians. Ian Cameron Chief Executive Officer, NSW Rural Doctors Network Suite 19, 133 King Street, Newcastle, NSW 2300 Western Australian Health Department (M Kamien, Chairman). Report of the Ministerial Inquiry into the Recruitment and Retention of Country Doctors in Western Australia. Perth: Western Australian Health Department, 1987. Shehadie N. Report of the Committee of Enquiry Into Services Provided by General Medical Practitioners to Country Public Hospitals. Sydney: New South Wales Department of Health, 1987. Bruening MH, Maddern GJ. A profile of regional surgeons in Australia. Med J Aust 1998; 169: 324-326. Kamien M. Staying in or leaving rural practice: 1996 outcomes of rural doctors' 1986 intentions. Med J Aust 1998; 169: 318-321. Hoyal FMD. Retention of rural doctors. Aust J Rural Health 1995; 3: 2-9. Hays B, Veitch PC, Cheers B, Crossland L. Why doctors leave rural practice. Aust J Rural Health 1997; 5: 198-203. Models of sustainable practice in rural and remote Australia. Discussion paper. Rural and Remote General Practice Program, Commonwealth Department of Health and Family Services, Canberra, March 1998. Increasing rural medical services. Discussion paper. Australian Medical Association and Rural Doctors' Assocation of Australia. Canberra, March 1998. - 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 Cameron

Environmental health 15 September 1998 Free

Protozoa in drinking water: is legislation the best answer?

Protozoa in drinking water: is legislation the best answer? A cooperative approach is a better option to protect public health MJA 1998; 169: 296-297 In late July, Australians were shocked to learn that the water supply in their largest city had been declared unsafe to drink because of protozoal contamination.1 In late August Sydney's water was again declared unsafe. The publicity surrounding these events in Sydney doubtless left most of the public, and perhaps many health professionals, with the impression that swallowing a mouthful of the affected water virtually guaranteed an episode of severe gastroenteritis. However, the magnitude of the risk to public health is far from clear as there are many limitations in our understanding of the biology of these organisms, and in the methods used for their detection in drinking water. Public and political concern has resulted in calls for legislative enforcement of water quality standards for Giardia and Cryptosporidium, but we believe that this approach is both unwise and unworkable at present. Such measures would require the setting of permissible levels for protozoa in drinking water, specification of sampling programs and approved testing methods. Uncertainties in all these aspects make it extremely difficult to define appropriate parameters to protect public health. Human infection: Information on levels of protozoa associated with illness is available from a small number of human experiments and limited data collected from outbreaks. For Giardia lamblia, a study of adult male prison inmates showed as few as 10 cysts could establish infection (determined by cysts in stools). However, none of the 40 subjects reportedly developed symptomatic giardiasis despite ingesting up to one million cysts, although 21 became infected.2 More recent human experiments,3 in which 50 000 Giardia lamblia trophozoites were inoculated into the duodenum, showed that with one strain all 10 subjects became infected and four developed clinical giardiasis. With another strain none of five subjects became infected or showed clinical disease. In human infection experiments with Cryptosporidium parvum, the minimum dose tested was 30 oocysts. Of five seronegative subjects receiving this dose, one became infected (oocysts in stools) but experienced no symptoms. At the next dose level of 100 oocysts, three of eight subjects became infected and developed symptoms.4 Waterborne outbreaks: Information derived from investigation of waterborne outbreaks is limited and difficult to interpret because of the time lag between the contamination event, the onset of symptoms in the exposed population and subsequent investigation to identify the source. For the Milwaukee cryptosporidiosis outbreak, which affected an estimated 400 000 people, the only data on oocyst levels came from samples of stored ice.5 A concentration of 13.2 oocysts per 100 L was found in ice made eight days before the outbreak was recognised. Maximum exposure to cryptosporidia probably occurred three days later (five days before the outbreak was recognised), when water turbidity rose suddenly to about seven times normal levels, signalling a failure of the water filtration plant. The process used to recover oocysts is noted for its variability,6 and this figure may be a substantial underestimate. Swimming pool outbreaks of cryptosporidiosis illustrate that illness can result from ingestion of a small volume of contaminated water, but, again, the time lag between a contamination event and examination of water samples makes it difficult to estimate actual exposure levels.7 Infected people can shed millions of oocysts per gram of faeces, so ingestion of tiny fragments of faecal matter may be sufficient to cause infection in other pool users.8 Safe drinking water: Overall, data presently available are insufficient to allow a "safe" drinking water level to be defined for these protozoa. It is theoretically possible that ingestion of even a single cyst or oocyst may carry a low risk of developing illness, but it is not feasible to test this hypothesis experimentally. Cryptosporidiosis may cause diarrhoeal illness lasting several days in healthy people, but in AIDS patients inability to clear the infection may result in severe and intractable diarrhoea which ultimately contributes to premature death. It is notable that during the Milwaukee outbreak people with HIV were not more likely to become ill than those in the general population.9 This suggests that the infectious dose for Cryptosporidium parvum is similar in both immunocompromised and immunocompetent people, although the consequences of infection are clearly different. There is evidence that the coagulation step used in water treatment to remove particulate matter causes clumping of coliform bacteria and spores, and similar effects may occur with protozoa. This would result in exposure of fewer people to larger numbers of protozoa than would be predicted from assumptions of uniform distribution in drinking water.10 Water testing: The formulation of a meaningful water sampling program is also a problem. Waterborne outbreaks are rare, and are believed to result from short term "spikes" of contamination from increases in protozoa numbers in the source water, or failure in normal water treatment processes, or a combination of both factors. A program based on spot sampling would be unlikely to detect contamination spikes, and could not provide statistically meaningful information on the very low numbers of protozoa which are normally present. Other parameters, such as turbidity or particle counts, may provide warning of abnormalities in water treatment processes (such warnings were unfortunately ignored in Milwaukee), but in some instances outbreaks have occurred without detectable changes in such measures or any identifiable breakdown in operating processes.11 Only Giardia and Cryptosporidium species of mammalian origin are believed to constitute a risk to human health, but current tests do not indicate the type of animal the protozoa originated from or the viability of cysts and oocysts. Several techniques to determine viability and species have recently been developed but are not yet fully validated. Considerable variability exists in the recovery efficiency of concentration techniques for isolating protozoa from water, making it difficult to compare levels between different studies and different laboratories.6 False positive results from algae and other particles of similar size and appearance to protozoa may also be a significant problem.12 Because of uncertainties about testing methods and the public health significance of low levels of protozoa in water, the National Health and Medical Research Council decided not to set guideline levels for protozoa in the 1996 Australian Drinking Water Guidelines, or to recommend testing for these organisms. Considerable progress has been made in detection techniques since then, but many problems are still to be resolved before we can accurately and reliably measure the number of viable protozoa of the relevant species. Nevertheless, major water companies are testing for protozoa with increasingly sensitive methods in an effort to improve the quality of their supplies, but water and health authorities are faced with a dilemma over what to do when positive results are found. Solutions: While legislation may appear to be the answer to this problem, we believe this issue is far too complex to be resolved in this way. The interests of public health would be better served by an open, cooperative approach bringing together the expertise of government, public health and the water industry. Australia would benefit from the development of best-practice programs, appropriate for the circumstances of different water supplies, and covering water quality from source to tap. Such programs are already being implemented in other countries.13 There is also a need to develop consensus protocols for graded responses to contamination incidents, and improved communication with the public and interest groups. Current surveillance mechanisms for communicable diseases are fragmentary, relatively insensitive and slow,14 and should be improved and integrated with water quality data to provide more sensitive and rapid detection of outbreaks. Cooperative research efforts are required to improve water monitoring techniques and confirmatory tests, together with appropriate measures for quality assurance. Only then will we be in a position to assess whether protozoa in drinking water are causing illness in the community, and determine appropriate measures to protect public health. Martha I Sinclair Senior Reseach Fellow Christopher K Fairley Associate Professor Margaret E Hellard NHMRC PhD Scholar Department of Epidemiology and Preventive Medicine and Cooperative Research Centre for Water Quality and Treatment Monash University, Melbourne, VIC Most of Sydney told: boil drinking water. The Sydney Morning Herald, 1998; 30 Jul: 1. Rendtorff RC. The experimental transmission of human intestinal protozoan parasites. II Giardia lamblia cysts given in capsules. Am J Hyg 1954; 59: 209-220. Nash TE, Herrington DA, Losonsky GA, Levine MM. Experimental human infection with Giardia lamblia. J Infect Dis 1987; 156: 974-984. DuPont HL, Chappell CL, Sterling CR, et al. The infectivity of Cryptosporidium parvum in healthy volunteers. N Engl J Med 1995; 332: 855-859. MacKenzie W, Hoxie N, Proctor ME, et al. A massive outbreak in Milwaukee of Cryptosporidium infection transmitted through the public water supply. N Engl J Med 1994; 331: 161-167. LeChevallier MW, Norton WD, Siegel JE, Abbaszadegan M. Evaluation of the immunofluorescence procedure for detection of Giardia cysts and Cryptosporidium oocysts in water. App Environ Microbiol 1995; 61: 690-697. Lemmon JM, McAnulty J, Bawden-Smith J. Outbreak of cryptosporidiosis linked to an indoor swimming pool. Med J Aust 1996; 165: 613-616. Chappell CL, Okhuysen PC, Sterling CR, DuPont HL. Cryptosporidium parvum: intensity of infection and oocyst excretion patterns in healthy volunteers. J Infect Dis 1996; 173: 232-236. Frisby HR, Addiss DG, Reiser WJ, et al. Clinical and epidemiologic features of a massive waterborne outbreak of cryptosporidioisis in persons with HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol 1997; 16: 367-373. Gale P, van Dijk PAH, Stanfield G. Drinking water treatment increases micro- organism clustering; the implications for microbiological risk assessment. J Water Services Res Technol -- Aqua 1997; 46: 117-126. Goldstein ST, Juranek DD, Ravenholt O, et al. Cryptosporidiosis: an outbreak associated with drinking water despite state-of-the-art water treatment. Ann Intern Med 1996; 124: 459-468. Clancy JL, Gollnitz WD, Tabib Z. Commercial labs: how accurate are they? J Am Water Works Assoc 1994; 5: 89-97. The partnership for safe water. American Water Works Association. <URL http://www.awwa.org/partner1.htm> Padiglione AP, Fairley CK. The early detection of outbreaks of waterborne gastroenteritis -- a feasibility study. WaterTECH Conference, Brisbane, April 1998. - 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/>

Martha I Sinclair · Christopher K Fairley · Margaret E Hellard

Medicine and the community

General medicine 15 September 1998 Free

Staying in or leaving rural practice: 1996 outcomes of rural doctors' 1986 intentions

Staying in or leaving rural practice: 1996 outcomes of rural doctors' 1986 intentions Max Kamien MJA 1998; 169: 318-321 For editorial comment, see Cameron Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - ©MJA1998 Abstract Objective: To examine the 1996 outcomes of a sample of Western Australian rural doctors who in 1986 had indicated their intentions to stay in or leave rural practice. Design: Postal questionnaire survey in December 1996, semi-structured interview and feedback by doctors on a draft of this article. Participants: 91 respondents from the 101 doctors who in 1986 had filled in a questionnaire on their intentions to stay in or leave rural practice. Main outcome measures: Proportion of doctors whose actions by 1996 were at variance with their intentions in 1986, and the reasons for their change of direction. Results: 49% (22/45) of doctors who intended to leave had stayed ("stayers") and 24% (11/46) who intended to stay had left ("leavers"). Doctors' main concerns in 1986 were overwork, lack of locum relief, professional contact with colleagues, specialist backup in emergencies, downsizing of hospital facilities, continuing medical education, and income. By 1996 stayers had solved most of these professional problems and felt they were doing a special job which made a difference to their community. Conversely, more than half the leavers were unable to solve these problems and felt disempowered and dispirited. Their most potentially solvable problems were overwork, forced deskilling and conflict with other healthcare professionals. Conclusion: Professional satisfaction was the main reason for doctors staying in or leaving rural practice. Professionally dissatisfied rural doctors reach a critical phase which they have to surmount if they are going to stay. An examination of the positive experiences of the stayers points the way to retaining at least half the potential future leavers. Introduction Much is known about recruiting doctors to rural practice, but less on how to retain them.1-3 A difficulty in researching retention of doctors in rural practice is a lack of baseline data on the intentions of the doctors. In 1986, the Western Australian Minister for Health commissioned an inquiry into the recruitment and retention of rural doctors.1 Those doctors who did not make written or oral submissions to the 1986 inquiry were then sent a questionnaire which included an item on how long they intended to stay in rural practice. The focus of my study is on those doctors whose subsequent actions by the end of 1996 were at variance with their stated intentions in 1986. Methods In 1986, 121 doctors answered questions on their intention to leave or stay in rural practice and on factors which would influence their decision. At the end of 1996, various local and national databases were used to find these doctors. Twenty were either retired, overseas or not on any Australian medical register. The remaining 101 doctors were sent a questionnaire and 91 returned a completed reply. The 1986 responses of those doctors were used to classify these doctors in 1996. If, in 1986, the doctors stated they would stay another five years and were still there in 1996, they were classified as "stayers". If, on the other hand, they said they would still be in rural practice for 10 or more years but left before 1996, they were classified as "leavers" (Figure). The 1996 questionnaires to leavers and stayers contained similar questions but were worded according to the doctors' intentions in 1986 and their actions by 1996. For example, leavers were asked if a lack of locum relief had influenced their decision to leave, while stayers were asked if the availability of locum relief had influenced their decision to stay. Data were analysed with SAS for Windows,4 using Fisher's exact test. To improve depth of understanding of the questionnaire responses, five randomly chosen leavers and 10 stayers were interviewed by one research officer using a semi-structured questionnaire. A further random sample of 15 respondents were asked for comment on whether the findings of my study conformed with their experiences and those of their rural practice colleagues. Results Eleven (24%) of those who intended to stay in rural practice in 1986 had left by 1996 and 22 (49%) of those who intended to leave had stayed (Figure). Six of the stayers had moved from one rural area to another: two from one regional centre to another; one from one rural practice to another; one from one remote practice to another; one from a rural practice to a salaried position in a regional hospital; and one from a remote to a rural practice. This last doctor was the only one to mention medicolegal concern as a contributory reason for changing from a single-doctor practice to a rural group practice. The main reasons for relocating rural practices were to prevent deskilling, especially in anaesthetics, and to reduce workload. There was little difference in demographic characteristics between the leavers and the stayers (Box 1). The only statistically significant variable was the unexpected finding that the leavers were more likely to have completed a rural internship (P < 0.05). Other unexpected findings were that the leavers were more likely to be practising in the medical discipline of their first choice and stated, in 1986, that they would choose the same discipline given their life over again. Although both groups had equivalent postgraduate qualifications in 1986, all but two of the leavers had acquired further qualifications before leaving rural practice. The most commonly held qualifications were a Diploma of Obstetrics and Fellowship of the Royal Australian College of General Practitioners. In 1986, the two main professional satisfactions of both the leavers and stayers were providing full and continuous patient care and the ability to practise procedural medicine. A third professional satisfaction was the feeling of doing a special job for their community, and this was reported by 11 stayers but by only one leaver (P < 0.05). Seventeen stayers also reported the social enjoyment and esteem of being involved with the community, compared with only five of the leavers. This involvement was distinct from simply enjoying the quality of life from living in a rural area. In the words of one stayer: "I enjoy the feeling of being a big fish in a small pond." This was not a statement of arrogance but of self- efficacy. In 1996, five of the leavers reported their spouses' desire to move as a contributory factor, but only one as a definitive factor, in their decision to leave, while two stayers reported their spouse's view as a major influence in their decision to stay. However, there was little difference between the spouses (all were female) of the leavers and stayers with respect to rural background, work situation, attitudes to a rural lifestyle and 1986 intentions to stay in a rural area beyond 1996 (Box 2). Of those spouses with a professional qualification, all were nurses, except for two who were primary school teachers and who left before 1996. There was no statistical difference between families in which one or both partners were professionals with regard to staying or leaving rural practice. Box 3 shows the importance of various retention issues in doctors' decisions to leave or stay in rural practice. In 1986, the stayers were more concerned with being overworked, unable to find locums, the lack of specialist backup when managing emergencies, the adequacy of hospital facilities, and income. By 1996, the stayers had solved most of these problems, and this was important in their decision to stay. Conversely, the leavers had been influenced to leave because of these problems, and had left before 1994, by which time many of the problems were being addressed by the Western Australian Centre for Remote and Rural Medicine (WACRRM), the Rural Doctors' Association of Australia (RDAA), the Australian Medical Association (WA) Locum Services and the Federal Government's General Practice Rural Incentives Program. The leavers' mean age at leaving was 42 years and the mean time for leaving was 4.6 years from when they were surveyed in 1986 (range, 1-8 years). The final decision to leave rural practice was made after periods of deliberation ranging from two months to three years (mean, 10 months). The main reasons why leavers left rural practice were a desire to change professional direction through specialisation or to pursue a special interest (eg, medical education), burn-out, and disillusionment from the downgrading of hospital facilities resulting in an inability to fully use their skills (Box 4). The main social reasons for leaving were children's education and difficulties with marital relationships. Overwork, deskilling, conflict with other healthcare professionals, lack of privacy, poor income and inadequate housing (all potentially solvable) accounted for 60% of the problems and involved six of the leavers. Box 5 shows the main reasons why those who intended to leave stayed in rural practice. More than 60% of reasons for staying were related to job satisfaction, with the remaining reasons divided between social and financial issues. However, 12 stayers reported that interference with factors which contributed to their job satisfaction would make them seriously consider leaving rural practice. This included bureaucratic interference from State or Federal government (6 doctors), downgrading of local services (3), and overwork (3). The next-most-common reasons which could cause doctors to leave rural practice were personal and family difficulties (5). Discussion The number of doctors who were stayers was twice the number who were leavers. In agreement with a recent Queensland study, the main reasons for staying were the professional satisfaction of the variety of work, autonomy of practice and the social and personal satisfaction of rural life.5 Also important was the feeling of doing an important job. Conversely, some leavers felt disempowered and unable to regain control over their own life. Although both groups had comparable qualifications in 1986, the leavers had acquired more postgraduate qualifications by 1996. This gave them greater options and possibly greater confidence to change their professional direction. In 1986, the eventual stayers reported a much higher prevalence of problems than did the eventual leavers. By 1996, the stayers had solved most of these problems, including the provision of those hospital facilities which enabled the full use of their clinical and procedural skills. This indicates that professionally dissatisfied rural doctors have reached a critical phase which has to be negotiated if they are going to stay. The most common profile for such a doctor is a man aged 42 years, discouraged by deskilling from downgrading of hospital facilities or clinical privileges, with children aged 13 to 15 years (when the hard decisions about schooling and matriculation opportunities have to be made). Much effort is required to discover and assist these doctors; this is an important task for organisations such as WACRRM, RDAA and rural divisions of general practice. For Queensland rural doctors, the triggers to leaving were difficulties in coping with change, perceived problems with secondary education for children, poor housing, and personality clashes with colleagues. The ultimate pressures to leave were constancy of after-hours work, difficulty in obtaining locum relief, access to continuing medical education, bureaucratic requirements and family pressures.5 These factors also apply in Western Australia. But also important were professional isolation and the downgrading of hospital facilities, preventing the full use of the doctor's procedural skills. These two factors would also influence many stayers to leave rural practice. This is illustrated by the statements of a stayer who relocated in order to maintain his clinical skills, and by a leaver: "I am self-reliant, and have become disillusioned by interference from outside agencies like the Health Insurance Commission, Medicare, government, the Australian Medical Association, the Royal Australian College of General Practitioners, Divisions etc. I am waiting for the day when I will be asked to relinquish my duties in accident and emergency because I do not hold a fellowship in emergency medicine -- it just seems to be the way things are moving. I also wonder if the day will come when I can auction my provider number like a crayfisherman with a crayfish licence." "I would have stayed except that I was forced to be deskilled. Prior to commencing rural practice I spent three years training in emergency medicine, anaesthetics, surgery, caesarean sections etc. There were no medical mishaps, yet these procedures were stopped in the two country towns I worked in." It is therefore important not to create unnecessary problems and, where problems exist, to counter them. Health departments, in particular, need to be clear about their aims and should value rural doctors as a scarce resource and include them in deliberations about change. The ultimate criteria for decisions on rural workforce and hospital facilities should be the maintenance of essential services sufficient to provide safe medical care to rural and remote Australia and to use the full skills of doctors already resident in those areas. In turn, rural doctors need to be more innovative and flexible in devising methods to reduce their professional isolation, practise procedural medicine, and gain some relief from being constantly on call. Flexibility is also essential from medical organisations and statutory bodies. The doctor in this study who left for financial reasons had a recognisable qualification in psychiatry and wished to practise it on a 40% time basis. National Specialist Qualification Advisory Committee regulations did not allow him to be classified as a consultant psychiatrist, making his practice financially unviable and depriving 80 000 people of resident psychiatric expertise. He commented: "I had a specialist qualification and was happy to use it but got no cooperation from the Commonwealth Government to come to some accommodation to pay for consultant psychiatric services. So I could only charge the same fee as a dermatologist for prolonged consultations and this simply wasn't financially viable. I was sad to leave after 10 years, but the more of my speciality I did, the less I earned, and we were simply getting deeper into debt." The increasing accent on rural issues in undergraduate medical education, the rising proportion of women doctors and the decreasing migration of doctors trained outside Australia make it difficult to estimate the needs for the rural workforce in the next decade. A 1997 study of Australian rural doctors predicts that only 50% will be in their current practice in 2007 and, for Western Australia, only 20%.6 Western Australia will therefore have to recruit 250 doctors over the next decade simply to keep pace with anticipated loss. Attention to factors shown to be important in retaining doctors would have an appreciable effect on reducing this loss. In this study more than half the doctors who intended to stay left for professional and, to a lesser extent, for social reasons which were potentially preventable. Reducing this avoidable loss is therefore an important factor in maintaining the rural workforce. The other main factor in retention is to understand and facilitate the conditions which reinforce the autonomy, efficacy and self-esteem of rural doctors. Acknowledgements Thanks are due to Mrs Rosalind Woodcock, who was a Research Officer on this project, and to all the doctors whose participation and insights made the project possible. This project was funded by the Australian Rural Health Research Institute. References Western Australian Health Department (M Kamien, Chairman). Report of the Ministerial Inquiry into the Recruitment and Retention of Country Doctors in Western Australia. Perth: Western Australian Health Department, 1987. South Australian Health Commission, Royal Australian College of General Practitioners (SA), Australian Medical Association (SA). Review of general medical practice in South Australia. Third report: country general practice. Adelaide: South Australian Health Commission, 1992. Strasser R. Rural general practice in Victoria: the report from a study of the attitudes of Victorian rural general practitioners to country practice and training. Moe: Monash University Centre for Rural Health, 1992. SAS for Windows [computer program]. Version 6.11. Cary, North Carolina: SAS Institute, 1995. Hays RB, Veitch PC, Cheers B, Crossland L. Why doctors leave rural practice. Aust J Rural Health 1997; 5: 198-203. Strasser R, Hays R, Kamien M, Carson D. National rural general practice study. Draft report. Moe: Monash University Centre for Rural Health, 1997. (Received 16 Feb, accepted 1 Jun, 1998) Authors' details University of Western Australia, Perth, WA. Max Kamien, MD, FRACGP, Professor and Head of General Practice. Reprints: Professor M Kamien, Professor of General Practice, University of Western Australia, 328 Stirling Highway, Claremont, WA 6010. E-mail: mkamienATcyllene.uwa.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/>

Max Kamien

15 September 1998 Free

A profile of rural surgeons in Australia

A profile of rural surgeons in Australia Martin H Bruening and Guy J Maddern MJA 1998; 169: 324-326 For editorial comment, see Cameron Abstract - Introduction - Method - Results - Discussion - Conclusion - References - Authors' details - - ©MJA1998 Abstract Objectives: To develop a profile of rural surgeons for comparison with profiles of rural general practitioners in the light of shortages in the rural medical workforce. Design: Rural surgeons were surveyed by a postal questionnaire in November 1997. Participants: Members of the Provincial Surgeons of Australia residing in towns with fewer than 50 000 inhabitants. Results: 239 questionnaires were sent and 137 surgeons replied, a response rate of 59%. Our survey showed that rural surgeons are predominantly male, middle-aged and married. They work long hours, and nominate as their major concerns difficulty in finding locum cover, continual on-call work, peer isolation, children's schooling, and lack of privacy. Conclusion: Rural surgeons and general practitioners share similar characteristics and concerns. Introduction There is a shortage of doctors in rural areas of Australia. For general practitioners this situation has been well documented,1 and now the focus has shifted to surgeons. The Australian Medical Workforce Advisory Committee has recently published comprehensive information on the general surgery workforce in Australia,2 with important demographic information about Australia's general surgeons, both urban and rural. A considerable proportion (estimated at up to 23.3%) of all general surgeons reside in rural or remote areas.2,3Despite the current interest by government and College groups, few published reports deal specifically with Australia's rural general surgeons. However, the Royal Australasian College of Surgeons (RACS) undertook a survey in 1997 of about 500 non-metropolitan general surgeons to build a database of surgeon demographics. Our study attempts to profile rural surgeons in Australia to compare with profiles of rural general practitioners. Method Our study was performed in November 1997. We used the 1997 mailing list of members of the Provincial Surgeons of Australia (PSA), an organisation that holds an annual conference at which rural surgeons can meet and discuss issues of relevance. Currently, 350 surgeons are members of the PSA. The term rural can be subdivided into rural major, rural other, remote major and remote other.2 For our study, we identified surgeons residing in towns with fewer than 50 000 inhabitants (ie, encompassing predominantly the categories rural major and remote major). Anonymous questionnaires were sent to these surgeons. From the original postal list, it was not possible to differentiate surgical subspecialties. Non-respondents were not followed up. Questions asked included specialty, qualifications, sex, age, marital status, number of children, length of time in current practice location, spouse employment and hours worked per week. Surgeons were also asked about the negative and positive aspects of their rural surgical practice. Discussion The low response rate of our survey may be attributed to several factors. Given the large number of hours worked by most of the study group, it may be that those who did not respond were simply too busy, or too fatigued or distracted, to do so. The rural workforce, now the subject of increased national attention, may also be suffering from "questionnaire burnout". Demographics The profile of rural surgeons developed from the respondents to our survey is that they are predominantly male, middle-aged and married. They work long hours, and most are well established in their current location and will remain there until retirement. Rural general practitioners and surgeons appear to have similar age distributions. In the early 1990s it was predicted that by 1998, 20% of rural general practitioners would be over the age of 60,4 and our proportion of 15% is not far behind. Without adequate input into the more junior ranks, the average age of rural surgeons will increase proportionately over the next few years.5 The Australian Institute of Health and Welfare medical workforce survey from 1994 found the average age of all specialists to be 48.8 years.6 Practice profile Frequent on-call work was identified as a major negative aspect of rural surgical practice. This is also often cited as a major disincentive to rural general practice, both in Australia7 and other countries.8,9 The rural divisional group of the RACS is establishing a national locum service and aiming to recruit surgeons nationwide to participate in the service. If successful, the service will relieve the burden of many rural surgeons, especially those in solo or two-person practices. The problem of lack of locum cover is also experienced by rural general practitioners and has long been a major cause for disenchantment and increasing the drift of practitioners back to urban areas.10,11 Another way of alleviating the pressure on a solo surgeon would be to provide a second resident surgeon in the same location. Some government reports have argued that, to provide a specialist service in a rural area, there should be a workload to justify a minimum of two specialists.12 This recommendation, although sound in theory, ignores the current shortage of rural surgeons.1,5 Moreover, the introduction of a second surgeon may disrupt long-established referral patterns, and any proceduralist general practitioners may be reluctant to give up one of the major incentives for pursuing rural general practice, as well as the extra income they receive for procedures.13 The issue of peer isolation has been raised in previous studies and continues to be a major concern for rural surgeons.14,15 A strategy such as the proposed RACS rural locum service, whereby metropolitan surgeons can appreciate the unique demands of rural practice, will not only achieve the immediate aim of providing locum cover, but may also change long-held city attitudes regarding rural medicine in general.16Increasing links and support from tertiary institutions as a result of the locum service will give a higher profile to rural hospitals. A separate initiative, which depends on the correct infrastructure being in place, is the introduction of rural surgical attachments for undergraduate medical students. This could provide many long term benefits: exposure of students to rural surgery may encourage more of them to take up the challenge of country practice,17-19 and an appreciation of the skills of rural surgeons could lead to a change in attitude regarding the overall standard of rural medicine. On the other hand, the rural surgeon may enjoy teaching and fostering university links. Family issues Schooling opportunities for children of surgeons were identified by our survey as a major negative aspect of rural practice. Many respondents were apparently dissatisfied with the available local schooling, as over 50% were sending or had sent their children to boarding school, no doubt at significant cost. General practitioners nominate the education of their children as one of the major reasons for not practising in the country.20 Given the shortage of education funding, it appears that, in the short term at least, the problem of establishing high quality schooling in all rural areas is insoluble. The importance of an understanding partner when deciding on country practice has been stressed recently.21 The high proportion of married surgeons among the respondent group would seem to support this theory. Moreover, a large number of the surgeons' partners were in some way employed within the practice. From the Results of our study it would seem that, with 41% of surgeons having spent some time as children in a rural area, a rural upbringing does significantly influence the decision to practise in the country. This concurs with numerous studies.17,22 Conclusion The Results of our study indicate that rural general practitioners and rural general surgeons share similar concerns and characteristics. Major efforts will be needed to arrest the ageing of the rural surgical workforce and improve the working conditions of current rural surgeons. References Australian Medical Workforce Advisory Committee. The medical workforce in rural and remote Australia. Sydney: AMWAC, September 1996. (AMWA Report 1996.8.) Australian Medical Workforce Advisory Committee. The general surgery workforce in Australia. Sydney: AMWAC, May 1997. (AMWA Report 1997.2.) Australian Institute of Health and Welfare. Medical Labour Force Survey 1994, Canberra: AIHW, 1996. Davies PG. Problems with training for general practice in South Australia. Med J Aust 1992, 155: 459-462. Royle JP. Rural surgery initiatives. RACS Bull 1996; 16(1): 42. Australian Medical Workforce Advisory Committee. Annual Report 1995-96. Sydney: AMWAC, 1996.5. Wise AL, Hays BRB, Adkins PB, et al. Training for rural general practice. Med J Aust 1994; 161: 314-318. Forti EM, Martin KE, Jones RL, et al. Factors influencing retention of rural Pennsylvania family physicians. J Am Board Fam Pract 1995; 8: 469-474. Anderson E, Beryeron D, Crouse BJ. Recruitment of family physicians in rural practice. Minn Med 1994; 77: 29-32. Kamien M, Buttfield IH. Some solutions to the shortage of general practitioners in rural Australia. Part 4. Professional, social and economic satisfaction. Med J Aust 1990; 153: 168-171. Hamilton IJ, Gillies J, Ross S, et al. Attitudes of general practitioners who practice in remote island communities. Health Bull 1997; 55(2): 103-108. Gadiel D, Ridoutt L. The specialist medical workforce and specialist service provision in rural areas. Canberra: AGPS, 1994. (MWDRC Consultancies No. 1.) Sax S, Andrews G, Brand I, et al. Enquiry into hospital services in South Australia. Adelaide: SA Health Commission, 1983. Nelson PG. General surgical manpower, Victoria, Australia. Aust N Z J Surg 1991; 61: 576-588. Faris I. The making of a rural surgeon. Aust N Z J Surg 1997; 67: 153-156. Chesterfield-Evans H. A mantle of care. 1991: 105-106 (available from Provincial Surgeons of Australia, PO Box 30, Kingaroy, QLD 4610). Rolfe IE, Pearson SA, O'Connell DL, et al. Finding solutions to the rural doctor shortage: the roles of selection versus undergraduate medical education of Newcastle. Aust N Z J Med 1995; 25: 512-517. American College of Physicians Position Paper on rural primary care. Ann Intern Med 1995; 122: 380-390. Kamien M. Undergraduate rural incentives programme. Med J Aust 1995; 162: 228-229. Kamien M, Buttfield IH. Some solutions to the shortage of general practitioners in rural Australia. Part 4. Professional, social and economic satisfaction. Med J Aust 1990; 153: 168-171. Adamthwaite DN. The making of a rural surgeon: comment. Aust N Z J Surg 1997; 67: 813. Fryer GE Jr, Stine C, Vojir C, et al. Predictors and profiles of rural versus urban family practice. Fam Med 1997; 29: 115-118. (Received 22 May, accepted 28 Jul, 1998) Authors' details Martin H Bruening, BM BS, FRCS(Edin), Lecturer in Rural Surgery. Guy J Maddern, MD, FRACS, R P Jepson Professor of Surgery. Reprints will not be available from the authors. Correspondence: Professor G J Maddern, Department of Surgery, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville, SA 5011. E-mail: sirelandATmedicine.adelaide.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/>

Martin H Bruening · Guy J Maddern

Medicine and the law

General medicine 15 September 1998 Free

Clinical practice guidelines before the law: sword or shield?

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

Matters arising

Doctors' working hours

Matters Arising Doctors' working hours Three articles (and a controversial cover photo) in our 15 June issue, highlighting the perennial problem of excessive working hours for doctors, have inspired comment from junior and senior doctors, and even doctors' family. MJA 1998; 169: 339-341 Shorter hours reduces training - William B Molloy Family concern - Annie Lee The forgotten generation - Terry G Coupland Treat the cause, not the symptoms - Michaela J Farrall In reply: Long hours are a financial reality - Leslie G Olson Smoking among doctors - Mark C J Craddock In reply: Recollections of smoking among doctors - Martin B Van Der Weyden ª 1999 Medical Journal of Australia.

Next Issue Volume 169 Issue 7

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Editorials 22 September 1998 Free

Surgery and evidence-based medicine

Guy J Maddern

Research 22 September 1998 Free

The prevalence of hepatitis C in patients admitted with acute hepatitis to Fairfield Infectious Diseases Hospital, 1971-1975

Jennifer A Thomson · Alison J Rodger · Sandra C Thompson · Amanda Byrne · Susan J Best · Nick Crofts

For debate 22 September 1998 Free

Should we be screening blood donors for hepatitis G virus?

Len D Moaven

For debate 22 September 1998 Free

Should we be screening blood donors for hepatitis G virus?

Ping-Yee Wong · Patrick J Coghlan · Peter W Angus

Previous Issue Volume 169 Issue 5

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Editorials 7 September 1998 Free

Peer review on the Internet: launching eMJA peer review study 2

Craig Bingham

Editorials 7 September 1998 Free

Paediatric rotavirus gastroenteritis: where to now in prevention and treatment?

Mark J Ferson · Richard Henry

Research 7 September 1998 Free

Re-engineering the elective surgical service of a tertiary hospital: a historical controlled trial

Gideon A Caplan · Ann Brown · Philip J Crowe · Su-Jen Yap · Shaune Noble

Research 7 September 1998 Free

Rotavirus infection and rates of hospitalisation for acute gastroenteritis in young children in Australia, 1993-1996

John B Carlin · Patty Chondros · Paul Masendycz · Helen Bugg · Ruth F Bishop · Graeme L Barnes

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