Letters

In reply: I welcome the comments on the physicians' charter. The purpose in publishing the charter was to promote a dialogue on medical professionalism, as, in contrast to the continuing discussion and debate on professionalism in North America1-3 and the United Kingdom,4 interest in the subject in Australia is virtually absent. Enter the terms "medical professionalism" and "Australia" in PubMed and the search yields eight publications in the Australian literature over the past 30 years. Despite this meagre tally, Breen informs us that all is well, through the efforts of bodies such as the Australian Medical Council (AMC). While the AMC's efforts are commendable, its recommendations for instilling professional attitudes in medical students and interns must compete with other priorities in an already crowded curriculum and with the pressures of the intern year. Under the daily stresses of real life, abstract concepts of professionalism are likely to be given low priority. Breen also suggests that the medical colleges are "poised to do more in this area". This may be so, but a search of college websites reveals that most are silent on matters of professionalism. Finally, Breen laments that the physicians' charter contains nothing new — but no one really expects revolutionary concepts in precepts of professionalism, which have evolved over hundreds of years. Besides, what harm is there in being exposed to the views of our colleagues in the northern hemisphere? As the comments of Gruen suggest, the charter is one of the more broad-ranging contemporary expositions of medical professionalism. Woollard wants evidence for the principles of the charter and its purpose. He also suggests that it is tinged with socialism and "political correctness". But the medical ethics that underpin our professionalism are dependent not on evidence but on humanistic principles. He hints that making the objective of all healthcare systems "the availability of a uniform and adequate standard of care" smells of socialism. Perhaps so, but I prefer to think of it as embodying the Australian ethos of a "fair go". Finally, "political correctness" is a subjective rather than an objective concept. I thank my colleagues for their insightful comments and for starting the debate on new professionalism. Long may it continue.

Martin B Van Der Weyden

To the Editor: Optimising the management of cancer patients requires objective decisions about "best treatment" strategies, based on high quality data collected systematically from all treated patients (or at least a representative sample of them). Relating treatment and stage at diagnosis to individual outcome can allow monitoring of whether treatment is consistent with best practice, and can provide a systematic foundation for evidence-based care. Clinical cancer data collection also allows treatment services to be evaluated, as institutions can monitor throughput and endpoints. However, institution-based data collections may not be representative of all cancer patients, and aggregation of data from several institutions is needed to obtain a comprehensive picture. Population-based cancer registries, which operate in all Australian States and Territories, include data on the site and morphology of cancers. Notification of cases to the registries is mandatory for hospitals and pathology providers, and survival of patients is assessed by linkage to mortality data. The registers do not routinely record stage or treatment data. Until recently, there have been no nationally agreed data items or standard data definitions to facilitate the collation of clinical cancer data across institutions. In 1999, the National Cancer Control Initiative (NCCI) commissioned a nationwide consultation process to seek expert advice on developing a core clinical cancer data set. Representatives from the State and Territory population-based cancer registries, the Australian Institute of Health and Welfare and many large cancer treatment centres were consulted.1 A workshop was held in Melbourne in July 2000 to identify key items for inclusion in the data set, and a group was established to work on data definitions. These are now available on the NCCI's website (<http://www.ncci.org.au/projects/data/dat01.htm>). The data set is designed to be compatible with, and expand on, data currently collected by State cancer registries. Definitions are consistent with the New South Wales clinical cancer data set,2 and we acknowledge the input from this source. Items would be collected by treatment centres. Some institutions would need to standardise information already collected for ongoing patient management, while others would need to establish and maintain new collections. The Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists has recommended incorporation of the NCCI data set into its proposed quality assurance program. Collation of data across institutions requires careful attention to patient identification issues in order to protect privacy and avoid duplication of data from multiple sources. Use of the data set by clinicians and health planners and evaluators at a national level is the ultimate aim. This would require funding and commitment, and attention to issues of privacy, confidentiality, and data ownership. At present, adoption of the data set on a voluntary basis by treatment centres is the best way forward.

Margaret P Staples · J Mark Elwood · Alan S Coates · Lizbeth M Kenny

To the Editor: We applaud the efforts of Wasiak et al to apply the principles of evidence-based medicine to answer clinical questions.1 However, it is important to understand the historical context of clinical trials reported in the literature, and, when necessary (eg, when conducting a meta-analysis or when the results of trials appear to conflict), to seek additional information from the authors. One of us (H K G) designed the randomised-controlled trial (RCT) reported by Corry et al.2 It was a pilot study and not a definitive clinical trial. The primary outcome measure was resonant frequency, an objective measure of muscle stiffness. This trial was conducted before the introduction of validated outcome measures for assessing upper limb function in children with cerebral palsy, and it was not possible to perform any sample size calculation for functional outcomes. At 12 weeks in the group receiving injections of botulinum toxin A, there was a significant difference in grasp and release but not in the ability to pick up coins. It is not surprising therefore that this study found significant decreases in muscle stiffness, but the functional results were inconclusive. The other RCT identified by Wasiak et al also involved one of us (D F).3 It was designed specifically to investigate functional outcomes, a sample size calculation was performed from pilot work, and a specific functional outcome measure (QUEST) was used. This study reported significant functional improvements after the use of botulinum toxin combined with occupational therapy. These two studies, when understood in their historical sequence, should therefore be considered complementary and not contradictory. It is important to assess the quality of randomised clinical trials as well as their conclusions (eg, using the Physiotherapy Evidence database PEDRO scale <http://ptwww.fhs.usyd.edu.au/pedro>).4,5 The smaller study by Corry et al2 had insufficient power and inadequate methodology to investigate functional outcomes. On the other hand, the conclusions of the study by Fehlings et al3 should be taken as the current level of evidence. We therefore submit that the conclusion drawn by Wasiak et al is incorrect. We support further research to evaluate and strengthen the evidence relating to botulinum toxin A and upper-extremity function.6

H Kerr Graham · Roslyn N Boyd · Darcy Fehlings

In reply: We thank Graham et al for their response to our article.1 It is important to understand that the clinician who posed the question regarding botulinum toxin A injection wished to find the "best available medical evidence". We were not asked to take account of the historical context of previously published articles, nor were we asked to exclude specific types of RCTs. If we were to exclude specific RCTs based on the preference of an author, then the strong methodological principles that surround the evidence-based practice movement would be open to extreme forms of bias. We also disagree that our conclusions were incorrect. Our reading of the article by Corry et al2 differed from that of Graham et al. We do not consider that their study showed that botulinum toxin injection significantly improved the function of the hemiplegic upper limb. Together with the results of the study by Fehlings et al,3 indicating a significant improvement in weight-bearing at four weeks (part of the QUEST assessment), our conclusion — that we could not support or refute the efficacy of botulinum toxin injections for improving upper-limb function in cerebral palsy because of differing opinions — remains unchanged.

Jason Wasiak · Brian J Hoare

To the Editor: I read with interest and alarm your comments on generalists and gerontology in the 16 September 2002 issue of the Journal.1 I believe the role of the general internal medicine physician in managing patients with complex multisystem disease is still important and will expand in the future. General physicians remain passionate about general medicine.2 General medicine has been threatened over the past 20 years by the emergence of the medical subspecialties. However, there is increasing recognition of the need for general medicine specialists, especially in North America and Europe. In Australia, general medical units are being established in the major teaching hospitals in capital cities. Sydney remains a unique exception — all of its general medical units were closed prior to the 2000 Olympics (for reasons that are unclear), and only one has subsequently been re-established (at Royal North Shore Hospital). The Internal Medicine Society of Australia and New Zealand (IMSANZ) has been active in promoting the role of the general physician. IMSANZ provides support for the professional profile and culture of general physicians throughout Australasia. We would welcome enquiries from trainees and physicians (<http://www.racp.edu.au/imsanz>). The Royal Australasian College of Physicians has recognised the necessity for a strong general physician workforce and will be holding a General Medicine Forum in March 2003 to examine the key issues confronting general medicine in Australia and New Zealand. By 2010 the majority of "baby boomers" will be in their sixties, or older, and will require the services of well trained general physicians to provide integrated, cost-effective, whole-of-patient specialist healthcare.

Leslie E Bolitho

To the Editor: Survey data are difficult to publish when response rates fall below 60%. Reminder letters are the most reliable method of improving response rates in postal surveys,1,2 and three to four reminders are needed to achieve the 60% benchmark. The additional benefit of sending five or more reminders appears negligible, suggesting that four is the optimum number to maximise response rates using this approach.1 Our recent experiences suggest that human research ethics committees (HRECs) are seeking to limit the number of reminder letters on the grounds that they could be construed as harassment of research subjects. We recently submitted applications to two HRECs, seeking permission to conduct a multicentre postal survey in our local area. One committee approved the use of a single reminder letter, while the second approved the use of two. We appealed both decisions, citing evidence from earlier studies.1,2 The first committee reversed its decision and subsequently approved use of three reminders; the second committee upheld its decision to allow only two reminders. Thus, our study was effectively restricted to two reminder letters. These experiences highlight two limitations of the ethics review process in Australia. First, the process is highly fragmented and lacks standardisation. HRECs exist as autonomous and independent entities, with varying interpretations of ethical practice. The decisions of one committee frequently undermine those of another. This is frustrating for researchers, who often have to seek permission from two or more committees during the course of a study. Second, the process confers higher status on the rights of study participants than on the methodological demands of science. Whenever there is any actual or perceived conflict between the two, HRECs consistently rule in favour of individual rights. Researchers are reluctant to challenge the decisions of their local committee, as there is no independent review process, and appeals are usually referred back to the original committee. The result is a directive and autocratic process which fails to consider the demands of scientifically valid research. Under current guidelines of the National Health and Medical Research Council, HRECs may endorse procedures that are potentially invasive or intrusive, provided certain conditions are met: the procedures are scientifically justified; there is no acceptable alternative; and reasonable steps are taken to protect individual rights. This certainly provides scope for sanctioning four reminder letters in postal surveys.

Stuart C Howell · Susan Quine · Nicholas J Talley

Comment: Howell and his coauthors invite human research ethics committees (HRECs) to standardise their judgements about key aspects of methods, such as response-aiding strategies.1 Their balanced and thoughtful analysis of their experience in securing approval from two HRECs for reminders to enhance response rates to a postal community survey adds to previous concerns about decision-making by HRECs in Australia.2,3 In an era of evidence-based healthcare, there are two main reasons to insist that HRECs only approve protocols for surveys that propose scientifically based procedures to increase response rates. First, applicants are applying empirical insights from previous research in their own practice. Hence, methods are evidence based. Second, applicants are doing their best to ensure the validity of their future data. As eloquently quantified elsewhere, surveys with low response rates are plagued by response bias.4 Indeed, it was recently asserted that, for mailed surveys, "you need an 80–85% response rate to make it epidemiologically significant".5 Fortunately, there is the most rigorous evidence (Level 1) for specific response-aiding strategies for surveys of medical practitioners in Australia.6 Howell and colleagues cite two recent studies of response-aiding strategies in lay surveys. Yet such compelling evidence appears to have been inadequate to secure identical responses from at least two HRECs. That both required Howell and colleagues to apply "homoeopathic" measures to their reminders (sending two rather than the proven four reminder letters) suggests that these HRECs may have been poorly apprised of the relevant scientific literature, unconvinced of its generalisability, or concerned about the acceptability of proposed procedures to research participants. As current National Health and Medical Research Council (NHMRC) guidelines provide a framework for approving research procedures that are "scientifically justified", it seems HRECs would benefit from regular and independent updates about key methodological advances, such as response-aiding strategies, their benefits, risks and harms. I am mindful that such methodological guidance must not add unnecessarily to the copious reading that is already typically demanded of members of HRECs. Perhaps the NHMRC Australian Health Ethics Committee could consider this issue in its next triennium, to commence 2003.

Jeanette E Ward

To the Editor: The recent information that methylphenobarbitone (60 mg tablets) will be unavailable after 1 January 2003 has caused anxiety in patients with epilepsy previously treated satisfactorily with this drug. The suggested substitution of phenobarbitone, primidone or a newer antiepileptic agent seems appropriate. However, patients and perhaps practitioners may assume, as my patients have, that phenobarbitone and primidone are equivalent to methylphenobarbitone on a milligram-for-milligram or a tablet-for-tablet basis. This may not be so. The equivalence is close to 30 mg of phenobarbitone for 60 mg methylphenobarbitone, and probably around 200 mg of primidone for 60 mg of methylphenobarbitone.1 Plasma phenobarbitone concentrations should be checked before and after any changeover. In recent years, several other old, but therapeutically satisfactory, neurological drugs have also been withdrawn from the Australian market (oral neostigmine, several anticholinergic antiparkinsonian agents, ethosuximide and some phenytoin preparations, and the only ergotamine preparation not also containing caffeine). Subject to safety issues, ethics committees usually will not approve a clinical trial of a new drug unless patients who benefit from it are guaranteed supplies until the drug is marketed. Surely similar considerations should apply for patients who have had completely satisfactory long-term responses to marketed drugs. If such drugs must be withdrawn, except for safety reasons, there should be extensive prior consultation with prescribers and patient groups, prescribers should know the situation before their patients discover it from other sources, and there should be a sufficient lead time for everyone receiving the drug to return for another prescription (and for advice) before the drug becomes unavailable (a minimum lead time of six months in the case of drugs subsidised under the Pharmaceutical Benefits Scheme). The withdrawal of useful neurological drugs in Australia has reached the stage where therapeutic options are becoming limited. In the case of drugs required for long-term use, to protect the interests of new patients it has become necessary to consider whether the drug will continue to be available for the expected duration of the patient's therapy. In this regard, the prescriber's only guide may be the track record of the firm which markets the drug otherwise chosen.

Mervyn J Eadie

To the Editor: The recent article by McLean and Higginbotham1 and the accompanying editorial by Melding2 highlight the problems faced by elderly people in aged-care facilities. It is likely that many elderly people living alone in the community are suffering equal, if not worse, pain. At a recent strategic planning meeting, the Australian Pain Society identified this group of people as a high priority for the development of pain management treatment strategies. These strategies are now well into the development process. While it is appropriate for the Journal to focus on medical practitioners' care of these patients, it must be remembered that most direct care for people in aged-care facilities is delivered by nurses and nurse assistants/carers. The Australian Pain Society will be focusing its strategies on non-drug techniques that can be used by this group of healthcare workers. Assessment and documentation of pain-related behaviour, particularly in people with cognitive impairment, is critical if progress is to be made. It is also important to appreciate the contribution in this area from other allied health professionals, such as physiotherapists, psychologists and occupational therapists. These practitioners have much to offer this patient group and have been important contributors to the Australian Pain Society's management strategies. It is hoped that State and federal funding can be made available for nurse educators to deliver these low-tech, non-drug management strategies within aged-care facilities. The two articles quite rightly focus on the regular use of simple oral analgesics, such as paracetamol, and low-dose opioids. Oral analgesics, together with more widespread use of non-drug treatments (eg, exercise, transcutaneous electrical nerve stimulation, hot and cold topical applications, relaxation, distraction, mental stimulation, lifestyle modification) and increased awareness among aged-care workers of the problems and solutions, should lead to an enhanced quality of life for this growing sector of our community.

C Roger Goucke

To the Editor: The articles by Melding1 and McClean and Higginbotham2 highlight the important problem of chronic pain in residential care. We have conducted two studies to investigate factors related to depression in residential care. In our first study, in 1994, we approached a random one-in-two sample of the non-nursing-home population of a Sydney retirement village (n = 1466). We excluded residents who were under 65 years, had severe dementia, were away from the village at the time of the survey, or were too deaf or ill to participate. Of 610 eligible residents, 513 participated (response rate, 84%). Of these, 42.1% lived in hostels and 57.9% in independent living units. In a second, similar study, in 2000–2001, we surveyed residents of three Sydney aged-care hostels (n = 205). Of 159 eligible residents, 148 (93%) participated. In both studies, residents were asked how often over the previous six months they had experienced recurring pain and asked to rate the severity of pain at its worst (see Box). Using the Geriatric Depression Scale (GDS),3 Study 1 found that residents reporting frequent/constant pain were significantly more likely to be depressed (ie, to have a GDS score ≥ 11) than people reporting rare/occasional pain; similarly, people who felt rare/occasional pain were more likely to be depressed than those with no pain (odds ratio, 1.44; 95% CI, 1.13–1.83). In Study 2, there was a non-significant association between frequent pain and depression (odds ratio, 1.47; 95% CI, 0.96–2.24). We implemented pain management programs at each facility. In Study 1, the program was part of a multifaceted intervention for depression,4 but residents could attend whether depressed or not. Based on general practitioner referral, the program provided interdisciplinary assessments by a visiting rehabilitation specialist together with a physiotherapist, occupational therapist and registered nurse from the facility. Consultative psychiatric input was also available. Neuropathic and musculoskeletal pain were the most common reasons for referral. Recommended interventions included drug treatment, exercise and preventive measures. Our impression was that they were well received by residents and GPs. In Study 2, residents with chronic pain were referred to a physiotherapist specialising in pain management and reported that this was beneficial. A clinical psychologist also offered to assist, but residents were reluctant to accept this form of help. Our impression was that psychological assistance would have been better received as part of an interdisciplinary pain management program. Older people in residential care may find it difficult to travel to hospital-based pain management programs. Our experience indicates that it is feasible to conduct pain management programs in residential care. However, improving pain management is not only a matter of pharmacological interventions. If we are serious about achieving adequate standards of pain management in residential-care facilities in Australia, resources should also be devoted to providing accessible interdisciplinary pain management programs and to changing the attitude that pain is an inevitable part of old age. Self-reported pain frequency and severity among residents of aged-care facilities Study 1 (1994) (n = 513) Study 2 (2000–2001) (n = 148) Pain frequency Not at all 230 (44.8%) 54 (36.5%) Rarely/occasionally 115 (22.4%) 52 (35.1%) Frequently/constantly 168 (32.8%) 42 (28.4%) Pain severity* Minimal/mild 58 (20.5%) 27 (28.7%) Moderate 98 (34.6%) 36 (38.3%) Severe/bad as could be 127 (44.9%) 31 (33.0%) *Severity rated only for residents experiencing pain.

Robert H Llewellyn-Jones · Karen A Baikie · Heather E Smithers · Philip D Funnell

To the Editor: In their editorial,1 Hammett and Harris have overlooked one of the most important contributory factors to the increased use of diagnostic tests by community-based practitioners (ie, GPs) — patient demand. It is not unusual for a GP to be faced with a request by a patient to be "tested for everything", or for a specific test that may be quite inappropriate ("I just want my hormones checked"). It takes far longer to explain to the patient that the tests are inappropriate than to give in and sign the appropriate pathology form. And then, if the patient a year later does come down with some obscure syndrome, he or she can come back in the courts and say, "If only the doctor had listened to my request for tests I would be okay now". The frontline GP is in a lose–lose situation, stuck between the Health Insurance Commission and its demands for reasonable levels of testing, the expectations of patients that everything can be detected by a blood test, and the excessively perfectionist ideals of the legal system.

Warwick Carter

In reply: As Murray notes, appropriate test ordering belongs firmly in the domain of quality care and clinical accountability. In his seminal article on clinical leadership of healthcare system improvement, Berwick lists appropriate use of testing and therapy as the first challenge facing people who wish to improve healthcare systems in the developed world.1 Murray also identifies the paucity of structured educational programs aimed at providing junior medical staff with the skills to exercise "knowledge and judgement" in test ordering. The Royal Australasian College of Pathologists is seeking to address this deficiency through the development of educational modules on test ordering. It is unlikely, however, that education alone will curb the increase in test ordering in Australia. Educational programs for junior medical staff are notoriously resource-intensive and difficult to sustain. In addition, they rarely provide the point-of-care guidance that seems to be more effective in sustainably modifying behaviour. Such guidance may require test-ordering software that provides guidelines for ordering and feedback of individual performance, or the use of structured test-stratification programs such as that described by Stuart et al.2 Improved education, supervision and point-of-care guidance will prove ineffective if fears of litigation continue to drive the behaviour of clinicians. As Carter points out, concerns about litigation must be considered in any program aimed at improving practice. However, although litigation related to missed diagnosis is a recurring theme, this may relate more to time pressures rather than a failure to perform investigations. Indeed, many malpractice suits result from failure to adequately check and act upon the results of the barrage of tests ordered. Attempts to reduce medicolegal risk by ordering all conceivable tests may increase practitioners' risk unless they have extremely well-designed follow-up systems. It is important that clinicians not sacrifice high-quality, evidence-based investigation and treatment in an attempt to minimise perceived litigation risks. By testing inappropriately, clinicians may in fact expose themselves to greater risks of litigation, as their patients are exposed to the risks of the tests themselves, the chance of false-positive results and inappropriate treatment, and the failure to follow up on investigation results. It is unfortunate, and an indictment of our current reimbursement system, that the financial realities of community practice make it difficult for clinicians to take sufficient time to communicate with patients about the appropriateness of an investigation or treatment. If we continue to allow this to become the way we practise, we will continue to see a diminution of our professional role as we become merely booking agents for tests. As Berwick says, "Efforts to reform the health system from the outside can help motivate and set the stage for improvement. Yet, if clinicians do not wish to make specific changes in their own work to better meet society's need for better outcomes and lower cost, no-one outside the health system can be clever enough or powerful enough to make them do it."1

Rohan J H Hammett · Roger D Harris

To the Editor: While agreeing that sensible utilisation of pathology tests in emergency departments (EDs) is important, we are concerned that the article by Stuart et al1 might be misinterpreted to justify wholesale reductions in important diagnostic microbiological tests, particularly blood cultures. Stuart and colleagues imply they could safely reduce the number of blood cultures by 80%.1 Other local data have suggested a minority of blood cultures in the ED influence patient management.2 Confirmation of aetiology will be denied for patients by "rationalisation" of blood cultures in EDs. Although most pathogens are susceptible to broad-spectrum anti-microbial agents, widespread empiric prescribing of such agents in an era of increasing antimicrobial resistance is unwise. A recent Australian study evaluating blood cultures found that a third of patients with positive blood culture results were not clinically suspected to be bacteraemic.3 Furthermore, the Journal recently reported the emergence of community-acquired methicillin-resistant Staphylococcus aureus (MRSA),4 and increasing resistance in Streptococcus pneumoniae.5 Missing MRSA or multidrug-resistant pneumococcal bacteraemia will result in adverse patient outcomes. What about missed cases of meningococcal disease, or typhoid fever, with their associated public health costs? Paradoxically, amid emerging antimicrobial resistance, we may become less aware of the problem. Furthermore, what about the infection control costs required to control the resultant outbreaks of multidrug-resistant organisms? Empiric broad-spectrum antibiotic prescribing, driven by failure to undertake important microbiological investigations, is bad medicine: It teaches everyone to guess the microbiological diagnosis, and, if you do not test, who can prove you wrong? Perhaps only when the patient presents to the tertiary referral hospital with therapeutic failure and evolving multisystem organ failure. It logically extrapolates to all patients getting vancomycin plus meropenem to ensure covering MRSA and resistant gram-negative bacilli. It inevitably drives resistance, which is increasing rapidly. It has never been subject to rigorous scientific scrutiny with cost-effectiveness studies. Moreover, the study by Stuart et al1 provides no data on readmission rates, lengths of stay, adverse events and rates of missed or incorrect diagnoses; the ED setting studied has limited generalisability; and United States guidelines, which may be inappropriate in the Australian healthcare context, were used to develop the diagnostic testing protocol. Might not reducing the ordering of some microbiological tests cause "spiralling therapeutic empiricism"? Might not the overall healthcare budget growth accelerate because of increased prescribing of expensive broad-spectrum antimicrobials?

Iain B Gosbell · Peter J Collignon · John D Turnidge · Christopher H Heath · Joan L Faoagali

To the Editor: The rate of growth of pathology and radiology testing over the last decade has surpassed the average growth of most other medical services.1 Pathology Medicare items processed per capita between 1996–97 and 1998–99 demonstrated the largest increase (8%) of all item types. The interventional program for reducing diagnostic testing reported by Stuart, Crooks and Porton shows promise in addressing this increase in the emergency department, and has significant potential across other hospital departments.2 The program's focus on initiating behavioural change among test-ordering staff as a precursor to effecting significant long-term reduction of test use is important. Views differ as to the reasons for excessive clinical testing among hospital staff. Medicolegal issues, level of experience, fear of the consequences of inadequate testing and the desire to diagnose within a single presentation have been previously described.3 These issues were dealt with to some extent via the described educational component of the authors' intervention program and seem to explain the apparent sustainability of the intervention. The authors report a "40% decrease in ordering of tests in the emergency department, with test utilisation falling from a mean of $39.32/patient to $23.72/patient." Other measures reported include reduced time taken for result review, with a resultant availability of additional resources for "other critical areas of service delivery". An assertion is made that "improvements to quality care" are "likely". Issues relating to improvement in quality of care, however, still remain: Although "no adverse patient outcomes relating to underutilisation of investigations" were identified, what follow-up was performed to ascertain "adverse outcomes"? What proportion of patients for whom further testing was requested via a general practitioner or outpatient clinic did not follow through with these investigations? Is there the potential for sufferers of undiagnosed chronic disease to develop more serious disease, requiring eventually more expensive therapies? What is the cost of patients' attending GPs and outpatient clinics for further investigations? Are the investigators' "evidence-based list of clinical indicators for ordering . . . tests" appropriate and are they rigid enough to prevent operator bias? Test utilisation measured by cost was the primary outcome measure for this study. Based on this measure, the results appear promising; however, important quality-of-care issues need investigation before more widespread implementation is considered.

Peter Gambell

In reply: Our intervention1 was developed following concerns with the quality of test ordering in our department, and resulted in a significant improvement in the checking and documentation of test results. Quality of care is also influenced by test over- and underutilisation. The study demonstrated a marked reduction in test ordering and accorded with the current estimates for test overutilisation.2 Test underutilisation was monitored using established mechanisms for reporting critical incidents (including missed or incorrect diagnoses) and patient complaints, as well as feedback from staff, general practitioners and other departments and hospitals. Patient outcome factors (eg, readmission rates, length of stay) were confounded by the dramatic onset of access block during the intervention period, making retrospective comparisons unreliable. The intervention is unlikely to have increased GP and outpatient referrals, as the previous practice of the department had been to refer patients having non-urgent tests (where the result was not immediately available) to a GP or outpatient clinic for follow-up of the test result. The department did not have the resources to ensure all patients attended for follow-up of the test result, raising medicolegal concerns and quality-of-care issues. The intervention, by deferring the ordering of non-urgent tests until after review, has the potential to reduce test duplication and the ordering of inappropriate (specialised) tests by junior emergency department staff. In addition, this process allows the patient's condition to be reviewed to determine whether further or alternative testing is required. Gosbell and colleagues speculate on the potential adverse outcomes that may follow from a reduction in the routine ordering of blood cultures. Blood cultures change patient management in only a fraction of cases, and the clinical situations where this occurs have been defined.3 A major concern is the high rate of false positive results and the consequent economic and social cost of additional unnecessary testing, treatment and prolonged hospital stay.4 As with any clinical tool, the use of blood cultures must be supported by evidence-based guidelines rather than based on expert opinion. The widespread use of blood cultures to limit the prescribing of broad-spectrum antimicrobial agents and development of disease resistance needs to be subjected to scientific examination and a cost–benefit analysis. If, as Gosbell et al seem to argue, the value of blood cultures lies predominantly in their public health role, the public have a right to be informed of the evidence used to substantiate the "test-all" approach being advocated to allow proper debate on the opportunity costs to public health.

Peter J Stuart

To the Editor: In advocating the use of questionnaire measures for outcomes for patients with depression or anxiety in clinical practice, Hickie, Andrews and Davenport advised that "for physicians who work predominantly in academic, specialist or administrative settings, the arguments for routine outcome measurement are obvious".1 The arguments are not at all obvious for clinicians. What is obvious is the divide between clinical practice and academia. The claim that there is now "an urgent need" to promote such questionnaires for general practitioners is difficult to understand. The historical and professional resistance to the use of such "instruments" is for good reason. They are unwieldy and unreliable. The oldest measure of outcome, known to clinicians but overlooked by academics, is to ask the patient "Are you feeling any better?", and to evaluate outcome using clinical skill and expertise. The key to understanding this peculiar proposition is to be found in the final sentence of the article, in its reference to the move for governments to "support major service innovations in primary mental healthcare". Those who produce, administer and measure such innovations will not, of course, see themselves unrewarded for their valued efforts to improve healthcare outcomes in the community. The poor GP will be burdened with yet another clinically irrelevant activity. Hickie and colleagues will no doubt press on regardless. There is a hint of insight, however, in the professorial obiter dictum that these measures would not be "the prime concern for the treating clinician". The "health services planning and other research benefits" of collating clinical data is a nice idea. It is hard to see its relevance to general practice based treatment of psychiatric disorder. If it is true that one out of three general practice consultations are driven by some psychiatric problem, then GPs will have a lot of forms to fill out, won't they?

Anthony Dinnen

In reply: It is pleasing to note that a senior psychiatrist is looking at the practicality of general practitioners (GPs) measuring the clinical outcome of patients with mental disorders. However, Dinnen's concerns may be groundless. For example, the Kessler Psychological Distress scale (K10) consists of 10 simple questions that patients can complete in two minutes in the waiting room and doctors can then score by summing 10 numbers between one and five.1 This takes less time than writing a progress note. The websites www.gpcare.org, www.beyondblue.org.au and www.mentalhealth.gov.au1-3 are the simplest places for doctors to familiarise themselves with the proposed outcome measures and with other new initiatives for better outcomes in mental healthcare. For the K10, the website1 advises GPs that if, after treatment, a patient's score remains above 25 the GP should review the patient and consider seeking a second opinion from a psychiatrist. In a specialist clinic (St Vincent's Hospital, Sydney) the average K10 score of a cohort of patients was 26.1 before treatment and 21.7 after treatment (indicating the effect of sound treatment). Nevertheless, the scores of a fifth of patients remained above 25 after treatment. Psychiatrists might therefore familiarise themselves with the measure so they understand when a GP refers a patient for a second opinion "with a K10 score above 25 after treatment".

Gavin Andrews · Ian B Hickie · Tracey A Davenport

To the Editor: Over the past 20 years, the prevalence of obesity in the Australian population has more than doubled — from 8.1% in 1981 to 20.5% in 2000.1,2 The rapid and widespread nature of the obesity epidemic suggests that environmental change is a major contributing factor. The patterns and types of foods consumed by Australians have changed markedly within a single generation. One major area of change is the availability and consumption of "fast" foods.3 A key feature of fast-food marketing is the use of "upsizing", a strategy designed to provide the consumer with a "value-for-money" addition to their meal. Upsizing is commonly employed within the context of "meal deals": complete meal options comprising the major food item (burger or chicken product) and, for a small extra cost, larger serving sizes of items such as hot chips and soft drink. Recent data from a US survey have shown that upsizing provides disproportionate increases in energy content relative to purchase cost.4 However, no published data have demonstrated the impact of point-of-sale fast-food upsizing on total energy, fat and sugar availability for Australian fast-food meal-deal options. On 28 July 2002, we purchased major meal deals and the advertised upsizing portions from the four major fast-food chains present in most large Australian cities: McDonald's, KFC, Red Rooster and Hungry Jack's. In order to assess six portions of each meal deal, we purchased two from each of three outlets. The weight and volume of chips and soft drink (non-diet variety) were measured, and nutrients were analysed using the AusNut and AusFoods Australian food databases.5 A summary of our findings is presented in the Box. On average, a 12% increase in purchase cost increased energy availability by 23%, with a 25% increase in fat (10.3 g) and a 38% increase in sugars (18.8 g). The upsizing meal option providing the greatest energy gain was the "fillet burger combo" from KFC (50% increase in energy for a 16% increase in cost). Large meal deals provided on average 5733 kJ (35.4% energy from fat and 21.4% energy from sugar). Based on data from the 1995 National Nutrition Survey, these single meal deals constitute 52% and 77% of the average daily energy intake of male and female Australians, respectively.6 Upsizing is a marketing strategy aimed at increasing the purchase cost of the items by providing the consumer with an added incentive or greater value. Using this strategy, upsizing meal deals double the energy gain relative to the additional cost. Importantly, upsizing also increases fat and sugar intake. With the growing disease burden of overweight and obesity on the Australian healthcare system, the public needs to be aware of the passive increase in energy consumption that can occur in pursuit of "value-for-money" eating options. Excess consumption of sugar and fat from fast-food meal choices adds mainly "empty calories" to the diet, with little nutritional gain and with a real risk of expanding the nation's waistline. Percentage increase in cost, energy content, fat and sugars for various upsizing meal options from four major fast-food outlets Percentage increase Cost Energy content Fat Sugars McDonald's Big Mac McValue meal (medium)* 10.1% 17.8% 16.2% 34.1% Big Mac McValue meal (large)* 20.2% 39.5% 33.1% 80.7% KFC Fillet burger combo (large)† 16.1% 50.3% 56.4% 52.7% Red Rooster Chicken roll combo (large)† 16.6% 27.5% 22.0% 39.7% Hungry Jack's Whopper value meal (large)† 9.2% 15.7% 14.4% 30.2% * % Increase relative to "small" size. † % Increase relative to "regular" size.

David Cameron-Smith · Shane A Bilsborough · Timothy C Crowe

To the Editor: These two cases, which occurred many years ago, illustrate a useful clinical sign in the diagnosis of tetanus. An elderly man was admitted to hospital after crushing his finger in a stable door. He commented in passing that when he whistled across the park to his wife that morning, she had not heard him. However, she had heard him the previous two mornings. He was a professional whistler on the radio and, when asked, still appeared to produce a good strong whistle. As it is the high pitch that carries long distances, I pondered the causes of selective pitch loss. I suspected the "risus sardonicus" of tetanus. He was subsequently confirmed to have tetanus and survived. Years later, a middle-aged woman with right hypochondral pain and presumed cholelithiasis presented to a country hospital for a cholecystogram. I chatted to her about her bandaged hand — she said that she had cut it on a jam tin in her house, but that her general practitioner was treating it, and all her vaccinations were up-to-date. Some hours later she complained that her abdominal pain was worse and had moved. I believed that the pain was probably related to movement of gallstones, but was more interested in her hand wound, of which she was dismissive. I asked her to whistle. It was a good whistle, but she commented, "It's not my whistle, I whistle the cows into the bales." Recalling my previous patient with the altered whistle, I diagnosed tetanus and arranged her urgent transfer to a consultant at Sydney Hospital (Sir Kenneth Noad). Indeed, she did have tetanus, and developed laryngeal spasm requiring emergency tracheotomy and 2.5 weeks in a respirator. Sir Kenneth later thanked me for saving the patient's life. The alteration of a person's whistle in tetanus can be explained as an early effect of the increased tone in facial muscles, which causes the classic risus sardonicus. As tetanus toxin must travel from peripheral nerve terminals to the nerve-cell body in the brainstem or spinal cord to exert its effects, muscles of the jaw, face and head, with their shorter axonal pathways, are often involved before those of the trunk and extremities.1

Eric R Dunn

To the Editor: In general, it is unwise for the medical practitioner to stray from those fields in which he or she is trained. To illustrate this point, I report the case of an anaesthetist (me) caring for a patient undergoing general anaesthesia for open repair of a fractured ankle. The operation was nearly over. The ankle had been repaired and the theatre nurse left the scene to assemble the materials needed for a leg cast. The patient was breathing spontaneously via a laryngeal mask airway. Before wound closure, the orthopaedic surgeon requested intraoperative radiography. A large X-ray machine was wheeled into the theatre, and the radiographer positioned it over the patient, took several images and then left to process the films. The surgeon wanted to resume surgery immediately, but who was going to remove the unattended x-ray machine, still poised directly over the operative field? I volunteered. I hit a button on the panel. It manifested as the command for "reverse": accordingly, the machine backed itself into the wall of the operating theatre, trapping me in between. At the same instant, a loud noise — consistent with partial upper airway obstruction — emanated from the anaesthetised patient. I had to free myself from my captor. Immediately. My release strategy incorporated pressing most of the buttons on the x-ray machine in a random manner. As all were imprinted with unrecognisable symbols, this seemed a reasonable, and eventually effective (if not a recommended), method for determining the "forward" function. I quickly returned to the patient's head and managed the airway problem. Thankfully, the patient's oxygen saturation did not decrease and the remainder of the anaesthetic was uneventful (the x-ray machine having been escorted out of the theatre by the radiographer on his welcome return). Although I had been willing and, in fact, keen to expedite the surgical procedure, I suggest that doctors avoid the lure of driving foreign vehicles (they can be savage beasts).

Richard H Riley

To the Editor: In 1995 and 1998 I was fortunate enough to have extended leave of several weeks. On both occasions, when I averaged out the weight of mail, excluding newspapers, waiting for me on my return, it came to about 7 kg per month. I wanted to determine the volume of communication I received in 2002, but: a substantial amount of my mail is now electronic; I no longer have extended holidays; mail cannot be now left unopened and unattended. It is opened by a trusted colleague, scanned into our patients' medical records and the originals left out for me to see on my return; being away would lead to a decrease in the mail I received; weighing individual mail articles would be a tedious test of sanity. So, I logged my mail for four weeks from 13 July until 9 July 2002. I have included neither mail addressed to me at home (which is now minimal and consists mainly of household bills and private correspondence) nor newspapers. A summary is shown in the Box; I have the individual log if anyone is interested. So, how to measure the communication load of a general practitioner? I have weighed it and counted it, but it was not practical to determine how long it took to read. This is because reading it necessitates acting on it, whether this means writing a reply, incorporating it into a patient's history or recalling a patient to order further tests. This communication load on GPs is significant and is a further indication of the complexity of our discipline. The weight of this load has significance for those wishing to communicate with GPs. Anything longer than a page runs a risk of joining the rapidly enlarging pile next to the GP's desk of material that must be read at the first opportunity. Anything else is condemned to the round filing receptacle under the desk. Correspondence received in four weeks 814 emails (62 individually addressed; 752 undirected from various mail groups). 451 individual pathology results downloaded by computer. 181 letters (147 individually addressed; 76 standard-sized letters, undirected, from various organisations; 58 oversized letters, undirected, from various organisations). 8 journals (4 subscribed; 4 unsubscribed). 8 broadsheets. 8 items of other mail, including books and packages of documents, weighing a total of about 3 kg. 112 faxes. Grand total: 1574 individual pieces of communication per month

Christopher D Hogan

To the Editor: "Chop-chop" tobacco is illicit tobacco that has been grown and clandestinely distributed by farmers and wholesalers and sold on without government intervention or taxation. There is no quality control over this illicit substance, which may be adulterated or "bulked up". It is sold illegally "under the counter" by weight for rolled cigarettes by unscrupulous tobacconists and grocers. This type of tobacco, which has been roughly chopped up (hence "chop-chop"), is very cheap compared with legally produced manufactured cigarettes. The prevalence of the use of chop-chop in the smoking community is unknown. However, the Australian Taxation Office (ATO) has a keen interest in the distribution of this substance, and estimates that many millions of dollars are lost in revenue from the illegal sale of chop-chop. Arrests and fines initiated by the ATO have so far occurred primarily in Queensland and Victoria. Results of analysis of chop-chop vary from batch to batch, but samples have been shown to contain nicotine (Professor G Starmer, Department of Pharmacology, and Mr B Tattam, Mass Spectrometry Unit, Department of Pharmacy, University of Sydney, personal communication). It may also be fumigated with bleach and may be bulked up to add weight (M Rushton, ATO, personal communication). Although most people smoke it because it is cheap, many have misguided beliefs, for which there is no evidence, that it is "better" than other forms of tobacco. Results of a survey of 44 consecutive patients attending the Smokers' Clinics of the Central Sydney Area Health Service 43% currently using "chop-chop" 84% smoke it because it is cheaper 58% believe it is better for you 74% believe it has no additives 16% believe it has no nicotine 63% know it is not legal A retrospective survey was carried out to assess the prevalence of and attitudes towards illicit tobacco smoking among patients attending the Smokers' Clinics of the Central Sydney Area Health Service (approved by the CSAHS Ethics Committee, June 2002). Patients were routinely asked the type of tobacco they smoked and their beliefs regarding this type of tobacco. The results are shown in the Box. Many of the patients attending the Smokers' Clinics (dedicated exclusively to patients who smoke and have chronic obstructive pulmonary disease [COPD]) smoke this type of illegal tobacco. Several patients volunteered that smoking chop-chop precipitated an acute exacerbation of their COPD. Four patients have recently presented to a hospital emergency department for exacerbation of COPD after smoking chop-chop. Although smokers are loath to volunteer their use of this illegal tobacco, smokers and clinicians should be warned that smoking chop-chop does not constitute a positive health move, is not less harmful, and may be quite dangerous. Quitting smoking altogether is the best health move.

Renee Bittoun

The Clinical Toxinology Resources website is now available at www.toxinology.com. It is a vast and growing searchable database, including 6000 images, designed to meet the needs of anyone seeking information on venomous and poisonous organisms throughout the world. Coverage is currently most complete for venomous snakes (over 800 species records); important spiders, scorpions and marine organisms are detailed, and new records are being added weekly. In the next few months, nearly 2500 poisonous plant records will be added, along with records of poisonous mushrooms. There is also a list of antivenoms and antivenom producers worldwide. The recently updated CSL antivenom handbook is available in its entirety; further toxinology resource documents will be added in the future. Access to the site is at two levels: a free general level or a more detailed subscription-based level aimed at health professionals. Subscribers can also log new cases using a secure system. The site was developed by the Toxinology Department of the Women's and Children's Hospital, Adelaide, and the Department of Paediatrics at the University of Adelaide, with the assistance of a small grant and the goodwill and time of a number of experts from Australia and overseas. Subscriptions will be used to help meet the considerable costs of maintaining and extending the site. MJA readers are cordially invited to visit the site and to consider supporting this endeavour by subscribing.

Julian White

To the Editor: Regarding the position statement about COX-2 inhibitors, we agree that openness about all potential conflicts of interest is the least we should expect from guideline developers, but this is not enough.1 Fifteen (65%) of the 23 members of the Australian COX-2 Specific Inhibitor Prescribing Group (including all eight of the rheumatologists involved) declared current financial links with Pfizer and Merck, Sharp and Dohme, the two drug companies marketing COX-2 inhibitors in Australia.2 The Prescribing Group can be viewed at best as a tight collaboration between some healthcare professionals and drug companies. At worst the statement published in the Journal can be seen as the "happy end" of a successful marketing campaign, which began some years ago with the enrolment of the most influential Australian rheumatologists to the advisory boards of the drug companies.3 Members of the group disregarded the "industry" bias on the basis that "some form of bias is the inevitable consequence of knowledge and involvement". However, numerous studies have shown that industry-sponsored drug information is characterised by an overemphasis on the benefits of drugs and a minimisation of the risks.4 Full trial results with celecoxib are available on the United States Food and Drug Administration website and had been consulted by the Prescribing Group.5 These data show that celecoxib is not better than diclofenac (P = 0.414) or ibuprofen (P = 0.64) in terms of ulcer complications, the prespecified primary outcome of the trials. There was also no significant difference between celecoxib and diclofenac for the combined outcome of complicated and benign ulcers (P = 0.296). It has been shown that the results previously presented in JAMA for celecoxib were flawed and had been manipulated.6,7 The wide distribution of the JAMA article by the drug company as part of intensive marketing campaigns contributed to huge sales for celecoxib. Sales of celecoxib between August 2000 and June 2002 cost Australian taxpayers more than $288 m through the Pharmaceutical Benefits Scheme (PBS), more than five times the cost for all other NSAIDs during the same time frame.8 There is some evidence to show that the PBS blow-out observed after the launch of COX-2 inhibitors is at least partly due to their use outside their approved indications (osteoarthritis and rheumatoid arthritis).9 The Prescribing Group did not give any indication for the use of COX-2 inhibitors and did not consider the cost issue, arguing that "there is little pertinent cost-effectiveness literature in the public domain". The position statement appeared to be an evidence-based review of the safety of COX-2 inhibitors involving eminent rheumatologists, active members of the PHARM committee and National Prescribing Service staff. We believe, however, that the statement promotes misinformation from the pharmaceutical industry. We invite readers to look at sources of drug information that are truly independent of drug companies, such as the Australian Medicines Handbook (www.amh.net.au), Australian Prescriber (www.australianprescriber.com) and Therapeutic Guidelines (www.tg.com.au).

Agnes I Vitry · Eve Hurley

To the Editor: We agree that the "what", "how" and "who" of guideline development all deserve equal, explicit and systematic attention.1 A fundamental task for architects of consensus guidelines is to get the "what" right first. Agreement about the importance of the topic and the objective of the exercise is crucial to its ultimate success. Edmonds and colleagues state that "formulation of precise indications for the use of NSAIDs [non-steroidal anti-inflammatory drugs] rather than CSIs [COX-2-specific inhibitors] (or vice versa) would generate interminable controversy".2 The foundation for this assertion is not clear and the authors do not present data about the level of agreement on this by the experts initially assembled. The NSW Therapeutic Assessment Group (NSW TAG) believes that providing timely, independent and evidence-based guidance to clinicians about the place in therapy for such new drugs is extremely important. The membership of NSW TAG identified this as a priority soon after the marketing of celecoxib in Australia, and agreed unanimously to develop evidence-based recommendations on indications for the use of this drug. Our consensus development process involved a wide variety of experts in therapeutics and was successfully completed without generating "interminable controversy".3 We wonder whether our different experiences may be partly related to a difference in the initial level of consensus on the importance of the chosen topic. The "how" of the process followed by Edmonds et al is not described in sufficient detail to enable systematic evaluation of its validity. How systematic was the search for evidence or the process for inclusion or exclusion of studies? What was the level of evidence on which final recommendations were based? Importantly, high quality guideline development processes require a "balance of healthcare disciplines in the guideline development group".4 Getting the right "who" is a prerequisite for getting the "how" right. Edmonds et al state that membership was arbitrary, with predominant representation from rheumatologists and relevant pharmaceutical companies. Given the problems associated with physician–industry interactions,5 it has been suggested that authors with significant conflicts of interest should be excluded from participating in guideline development.6 The rationale for arbitrary selection of members and inclusion of members from the pharmaceutical industry is not explicitly stated. These issues may have contributed to the difficulties the group experienced, and may detract from the validity of their recommendations. Future trips down the "road to consensus" should run more smoothly after careful consideration of the "what", "how" and "who" at the outset — no "ifs and buts" about it.

Madlen Gazarian · Karen I Kaye