Letters

In reply: Both Vitry and Hurley and Gazarian and Kaye would have had our consensus group address different or broader issues than safe prescribing and use of COX-2-specific inhibitors (CSIs). Indications for use, leakage and cost effectiveness are important issues, but our goal, clearly stated in our article,1 was different and, we believe, important: if a clinician has decided to use a CSI, what considerations are needed to prescribe the drug safely? Disagreements in reaching consensus were not, as suggested by Gazarian and Kaye, due to confusion about the aim of the exercise, but to differences in interpreting evidence and expressing conclusions in simple and direct terms. It would have been easy to avoid these problems by limiting participants to a small group of like-minded colleagues, but we chose to involve a broad range of people who may represent a more realistic spectrum of attitudes and approaches. We find Vitry and Hurley gratuitously pejorative in their description of the participants in this exercise. With the exception of two rheumatologists with epidemiological expertise (who did not sign off on the position statement2), all the rheumatologists involved were members of one or both advisory boards. They were a relevant group precisely because this role should involve a responsibility to provide sound advice to the industry paying for it, and equally to the profession, both in the interests of good patient care. "Current financial links" is not the way such a consultancy is usually described. They call the exercise "at best a tight collaboration between some healthcare professionals and drug companies" and "at worst . . . as the 'happy end' of a successful marketing campaign". Given that one of the two pharmaceutical companies involved declined to sign off on the statement, as did two rheumatologists who were advisory board members for the other company, this is a curious outcome of "tight collaboration". With respect to the relative safety of selective versus non-selective COX inhibitors, our considerations were based on data available from peer-reviewed studies published to the end of May 2001 and available on the United States Food and Drug Administration website, as indicated in the position statement2 and the accompanying article.1 A number of the references quoted by Vitry and Hurley became available after May 2001. Renewed scrutiny and analysis of existing datasets is interesting, but the results are best used to decide whether unresolved issues are of sufficient importance to justify further studies, and how these could be designed to deliver evidence that will convince us all, one way or the other. We made the point at the conclusion of the position statement that this is an evolving field and that conclusions may well change with emerging data.3 We consider the statements made in the considerations article1 represent a fair expression of our assessment of the data available to us. Not everyone in the group agreed. In publishing the position statement with the list of participants who endorsed it and those who did not, and by adding an article on the process we adopted, we hoped to highlight the fact that there are controversies and uncertainties about aspects of CSIs which require careful consideration in clinical use and further high quality data to resolve currently unresolvable issues.

John P Edmonds · Richard O Day · James V Bertouch

To the Editor: Advocating implementation of evidence-based clinical practice guidelines is one aspect of the current drive to provide quality healthcare across different centres. Quality theory demands that outcomes are continuously sought and that practices are modified accordingly — the "quality loop". Therefore, Scott and Harper are to be applauded for their pursuit of improved outcomes, not just improved processes, in studying guideline-discordant care in acute myocardial infarction.1 I believe that this type of study, which objectively demonstrates the role of practice guidelines in "real world" practice, is very important. However, as a geriatrician, my patient population is unlikely to intersect with populations enrolled in large cardiology trials (eg, those for thrombolysis in myocardial infarction).2,3 Comorbidities, such as renal impairment, cognitive impairment and poor functional status at baseline, were not explicit exclusion criteria, but, when present, would have reduced an individual's chance of being enrolled. These types of comorbidities are likely to be associated with a reluctance on the part of patients and physicians to pursue life-prolonging interventions. They are also likely to be associated with poorer outcomes, whatever the intervention. Therefore, I believe that these non-cardiac comorbidities are potential confounders for study designs, such as that of Scott and Harper.1 Older age per se has been well studied in the cardiology literature on management of myocardial infarction. However, in the literature on adherence to guidelines, few studies have attempted to fully identify the non-cardiac-related characteristics of those receiving guideline-discordant care. Krumholz et al reported that altered mental state is one factor, and that, of a large "real-world" cohort aged 65 or more, only 8% were considered ideal candidates for thrombolytic therapy.4 Quality healthcare involves multiple dimensions, including both personal and process factors. Practice guidelines are valuable tools to reduce practice variation, but we need to continue to evaluate whether they can be applied as broadly as may be advocated. Surely, evidence-based guidelines can only be confidently applied to situations for which an evidence base exists. It will be important to test the application of guidelines in many settings, with attention to potential confounders, and, in particular, to outcome measures.

Kristen J Pearson

In reply: We thank Pearson for her kind comments and agree the design of our study1 prevented identification of all patient factors that may, quite reasonably, impact on clinicians' decisions to administer specific treatments to older patients with acute myocardial infarction (AMI). These factors may also have precluded such patients from enrolment in clinical trials, the results of which underpin recommendations within clinical practice guidelines. On the other hand, we know advancing age is an independent predictor of increased mortality after AMI, with several possible causes: age-related reductions in protective mechanisms (such as myocardial preconditioning),2 presence of cardiac and non-cardiac comorbidities unaffected by treatments for AMI,3 and — the focus of our study — underuse of effective therapies in the absence of discernible contraindications.4,5 While cognitive impairment, renal dysfunction and poor functional status may dissuade patients and/or clinicians from pursuing "aggressive" management, we have no evidence that these factors, singly or in combination, necessarily attenuate the benefits of specific interventions for AMI in patients at high baseline risk of cardiac death.6 We also adjusted mortality comparisons between concordant- and discordant-care groups for multiple measures of illness severity at presentation which predict a poor prognosis. Nevertheless, we support calls for more randomised trials of treatments for AMI and other conditions in older patients with liberal, "real-world" inclusion criteria in determining absolute risks and benefits of intervention in the presence of multiple comorbidities and impaired function.

Ian A Scott · Catherine M Harper

To the Editor: Several studies have documented the high incidence of adverse events arising during hospital admission. The potential for discontinuity of care and poor communication is significant when patients are admitted to and discharged from hospitals, hence the Australian Pharmaceutical Advisory Council (APAC) has established guidelines to ensure continuity in the quality use of medicines.1 A study reported in 2001 by Mant et al found very low compliance with a minimum dataset based on the APAC guidelines.2 These authors subsequently held workshops to identify problems, develop action plans and refine these strategies. However, the follow-up report, published recently in the Journal, reported little change in adherence to the minimum dataset.3 Why are providers failing to follow the APAC guidelines? Certainly, one cannot assume that the formulation and dissemination of guidelines will necessarily lead to their implementation.4 To be effective, users must be aware of guidelines and convinced that they will add value to the way in which they work. Guidelines need to be credible and should make sense in the "real world". Given the attitudinal barriers of some groups to the uptake of guidelines, multiple strategies are required to ensure their effective implementation. Among these is the involvement of key stakeholders in guideline development. Who are the key stakeholders for ensuring continuity of care regarding therapeutics between hospital and the community? While Mant and colleagues report workshops involving general practitioners and hospital staff, their reports do not identify which hospital staff were involved.2,3 Were clerical, pharmacy and junior medical staff included? These staff could make a critical difference in adherence to the minimum dataset. Furthermore, are these staff even aware of the APAC guidelines? The APAC guidelines use the definition of discharge planning established by the Council on the Ageing (Victoria). This describes people, hospitals and community-based services working together — but the guidelines and associated minimum dataset place little importance on the patient. Patients' knowledge of their medications is discounted. Despite being mentioned in principles 4 and 6 of the APAC guidelines, patient knowledge of medication changes and satisfaction with the communication regarding medications is not considered in the minimum dataset.1 Strategies involving consumers should be explored as a mechanism for improving information exchange between hospitals and GPs. Similarly, an enhanced role for pharmacists warrants further consideration.5 Certainly, further critique of the APAC guidelines and exploration of reasons for their poor uptake is important to ensure optimal patient outcomes.

Michael Jefford · Joanne L Clancy · Sharon M Butler

To the Editor: It is refreshing to see quality initiatives like that of Mant et al,1 which examine issues of continuity across different territories. Use of a simple audit tool (minimum dataset) and methodology has worked well to illuminate what misleadingly appears to be a simple problem (ie, the two-way exchange of information between the hospital and general practitioner in relation to medication). Unfortunately, like many problems that appear straightforward and easily fixable, the reality is that this issue is far more complex to address. A lack of clinical governance has been made apparent in both the public hospitals and the Divisions of General Practice that participated. Clinical governance demands that organisations be accountable for standards and performance in relation to clinical care,2 and this is integral to addressing problems both internally and across the continuum of care. Mant et al demonstrated that many hospitals had policies and strategies to accomplish the exchange of medication information,1 indicating that these procedures were thought to be achievable with current resources. Before this study, knowledge among staff of implementation was scant and confused, and there was no system of review to reveal existing problems. When problems were exposed and changes made, staff were not upskilled to incorporate the change into their practice (eg, junior doctors not completing the new discharge referral form). Similarly, the Divisions of General Practice did not resolve issues surrounding the production and distribution of business cards that they had agreed to undertake. This study has determined a means to measure performance and has intervened to analyse problems and yield some improvements. However, if the organisations involved do not commit to develop clinical governance, the path towards continued improvement will be extremely slow (if at all) and the findings of this project made irrelevant.

Catherine L Wilson

To the Editor: Mant et al1 explore an important aspect of the quality use of medicines in their study on the continuity of medicines from hospital to community. Their study on compliance with an agreed minimum dataset for patient medication information exchange between hospitals and general practitioners provides a useful perspective of an approach to systems change. I wish to point out a number of limitations that may have affected their results and make some suggestions to improve the quality use of medicines. GPs were audited on whether they provided medication information to hospitals. Many GPs work part-time. There is the possibility that the medical practice was contacted by a hospital employee, who obtained the information from a doctor other than the patient's usual GP. The audit covered discharge summaries received by the GP by fax. Although faxing discharge summaries is convenient, there are potential problems with this method. There are the possibilities of dialling a wrong number, and faxed discharge summaries (particularly handwritten ones) may be difficult to read, which could also result in medication errors. In addition, a discharge summary may have been posted to the practice instead of faxed, which would under-report the true percentage of GPs who received the information. It is not uncommon for patients to have multiple GPs.2 However, it is my experience that only one GP is documented in the patient's medical file. This issue could have influenced the results of the GP audit and would be a further factor complicating the continuity of medicines from hospital to the community. The authors mention the introduction of GP liaison officers to facilitate the notification of GPs about patient admissions and the rationale for medication changes. They do not report any other measures that they plan to introduce to improve their results. Given that systems problems have multifaceted answers, further expansion on what other steps could be taken would have been a useful addition to their article. I suggest that it would have been appropriate to include a broader range of key stakeholders in the workshops, such as community pharmacists and patients. In addition, a computerised hospital prescribing system could be integrated with an on-line evidence-based clinical guide to prescribing to assist in optimal medication selection. This could also be used to generate a discharge medication list that was automatically sent to the patients' GPs. Such an approach would reduce errors and improve outcomes.3,4

Peter W New

In reply: We were pleased at the number of letters received exploring issues raised by our recent article.1 Jefford and colleagues question whether staff are aware of the Australian Pharmaceutical Advisory Council guidelines.2 We expect to answer this question during the consultancy that the NSW Therapeutic Assessment Group is conducting for the Commonwealth Department of Health and Ageing. In this consultancy, we are evaluating the implementation and effectiveness of these guidelines. After its completion in October this year, we will have an implementation map of activities being undertaken relevant to the guidelines in Australia. Recommendations formalised at a national workshop will be made to the Department of Health and Ageing regarding future implementation, including alternative models and workable solutions. All three letters raise questions about the key stakeholders for continuity of care. We invited a range of clinical and administrative staff, including senior and junior medical staff, nurse clinicians, clinical pharmacists and general practitioners from the relevant Divisions. However, participation of junior medical staff was limited. As Jefford et al comment, consumers and community pharmacists warrant further consideration in strategies for improving information exchange between hospitals and GPs. We also agree that patients' knowledge of their medications is often deficient: with limited resources, we were only able to address this through the GPs who interviewed their patients following discharge. Wilson rightly observes that continued improvement is dependent on organisations' developing clinical governance — accountability is a key driver for change. Change in practice is usually incremental, however, as we found in our study. Sustained change requires ongoing effort and support. New comments on practical problems with faxing discharge summaries. In our study, GPs identified faxing as preferable because of problems experienced with summaries posted or delivered by patients. New also refers to the problem of patients having multiple GPs. It is up to the patient to advise the hospital appropriately, and this is a matter for consumer education. His suggestion of computerised hospital prescribing is an ideal we all hope will come to fruition sooner rather than later. In the meantime, we believe we have demonstrated the quality improvement process and its limitations and the value of GP audit in prompting that process.

Andrea Mant · Karen I Kaye · Linda Kehoe · Wendy C Rotem

To the Editor: Thanks for the interesting opinion pieces by Reid1 and Paterson.2 Would I be correct in assuming that they are the Reid and Paterson who were formerly health bureaucrats in New South Wales and Victoria, respectively? May I suggest that your readers, especially those interstate and overseas, would have been better informed on the import of these articles if you had made some editorial mention of this fact? In this era of "career-hopping" between industry, government and academia, your readers, if they are to intelligently interpret an opinion piece, need to know more than merely the present position held by the author. You rightly ask about the "competing interests" of contributors of research articles. Perhaps the writers of opinion pieces should declare their background?

Peter Arnold

In reply: As always, I appreciate Arnold's input, and he is right yet again: M Reid was Director-General, New South Wales Health, 1995–2001, and J Paterson was Secretary, Health and Community Services, Victoria, 1992–1996. This information was conveyed in the author's details for Paterson, but inexplicably not for Reid. The Journal asks its contributors to declare "competing interests"; that is, disclosure of "any situation in which an individual . . . might be influenced . . . by financial or personal factors that involve self-interest".1 Most journals, including the MJA, choose to focus on competing financial interests, but an ongoing quandary is where to draw the line in the sand of competing interests — should they be religiosity, sexuality, consultancy within the political or health bureaucracy, or positions on committees or advisory boards, and so on? Arnold wishes to move to a higher plane through disclosure of relevant areas of contributors' life stories, presumably to alert readers to the potential for bias. But might not the publication of a contributor's relevant career prejudice the response of the reader? Kenneth Rothman, editor of the journal Epidemiology, has argued that objectivity in communication "depends on each contribution receiving its due regard, whatever the motivations for bringing it. It depends on judging a work on its merits, rather than on the inferred state of mind of the author".1 The contributions by Reid and Paterson were published under the Journal's For Debate banner. I was hoping for a debate on the messages rather than the messengers.

Martin B Van Der Weyden

To the Editor: The Victorian Health Records Act 2001 became operational on 1 July 2002. This legislation provides important protection for the individual against misuse of health information through the establishment of Health Privacy Principles. We support the spirit of this legislation, but would like to draw attention to its potential effects on multicentre research and disease surveillance. We recently began a study to estimate the burden of invasive group A streptococcal disease in Victoria. The study involves identification of patients through laboratory notifications, followed by collection of clinical data — a strategy similar to surveillance of notifiable diseases. The study is funded by the National Health and Medical Research Council. We have sought institutional ethics committee approval, and are obtaining individual informed consent from patients. Despite approval from the Human Research Ethics Committee of the Victorian Department of Human Services, concerns arising from the new privacy legislation led most Victorian healthcare institutions to also require approval by their own ethics committees. We have now applied to over 30 separate committees, and the process is not yet complete. This has been an enormous drain on resources, has necessitated our establishing complex administrative procedures, and delayed commencement of the project. Moreover, many committees have required that we pay an application fee of several hundred dollars. Some have been uncertain about the implications of the new legislation for our project, and have requested clarification from the Victorian Health Services Commissioner. Despite these processes, some clinicians we have contacted are unwilling to allow their patients to be approached for fear of breaching privacy legislation. Our protocol is not controversial, and no substantive issues have been raised by any of the ethics committees. While ethical clearance is crucial to the success of the project, we were unprepared for the amount of work, confusion and expense involved. It is possible that these difficulties could discourage other researchers from conducting similar studies in Victoria. Similar concerns have been raised in the United Kingdom since the introduction of new privacy laws.1 The Victorian legislation allows for research and surveillance activities using identifying data if they are in the public interest, or if it is impracticable to seek individual consent. However, the legislation does not provide guidelines on what constitutes public interest or when consent is impracticable. The extent to which this legislation affects multicentre research or surveillance projects needs to be clarified, and a more simplified ethical approval process for surveillance activities identified.

Jonathan R Carapetis · Jonathon W Passmore · Kerry Ann O'Grady

Comment: It is unfortunate that a valuable research project has apparently been made more difficult or delayed by the combination of complex new privacy law and longer-standing inefficiencies in the ethical review of multicentre research proposals. Both are issues with which the Australian Health Ethics Committee (AHEC) is grappling at present. Multicentre research was identified as a significant issue in the review that led to the revised 1999 National Statement on Ethical Conduct in Research Involving Humans.1 The Statement makes it clear that researchers have a role in negotiating with human research ethics committees and institutions to seek agreement that the ethical and scientific assessment of one committee or institution will be accepted by other sites. The National Statement equally empowers ethics committees to minimise unnecessary duplication. Ethics committees have been very slow to grasp the opportunities offered by the 1999 National Statement for reasons that may include the past practice of insisting that each committee make its own assessment. Initiatives are now in train in New South Wales, Victoria, Western Australia and Queensland to develop different forms of centralised assessment, but the benefits may take time to be realised. AHEC, through its bulletins and workshops for ethics committee members, has repeatedly reminded committees how to simplify multicentre review, but traditional practices appear to have obstructed this message. This letter is yet another opportunity to remind ethics committees and institutions that the National Statement permits and encourages them to exercise initiative, judgement and common sense in facilitating effective and timely review of multicentre research. With regard to the difficulties associated with the new privacy regimes being put in place by a combination of federal and State laws, AHEC anticipated some introductory problems in relation to human research. It is understandable that ethics committees and researchers will take time to adjust some of their established practices to comply with the law and associated guidelines. During the period of adjustment, some flexibility needs to be exercised by all parties. AHEC conducted a series of workshops in all capital cities earlier this year to assist researchers and ethics committees in this phase. An explanatory guide to the use of privacy law and the associated guidelines from the National Health and Medical Research Council was used at these workshops and will be made more widely available shortly. Finally, the federal legislation will be the subject of a systematic review after two years. Unintended consequences of the law should be addressed at that time. AHEC understands that, in Victoria, the Health Services Commissioner, whose office has responsibilty for supervising the application of the health privacy law, is in the process of producing a practical guide for Victorian healthcare researchers.

Kerry J Breen · Sandra M Hacker

Comment: As I understand Carapetis et al's study, the researchers determine who has a group A streptococcal infection from the laboratory that performs the test (as this infection is not a notifiable disease,1 there is no central source of information). The laboratory may be independent or in a public or private hospital, and may be situated anywhere in Victoria. The laboratory tells them who requested the test and the patient's name and infection status. The researchers then seek assistance from the hospital or doctor requesting the test in obtaining "individual informed consent" from the patient to release clinical information to the researchers. Each institution has required that its own human research ethics committee approve the project, as well as the Department of Human Services (DHS) Ethics Committee, before the laboratory releases information. This accords with the law, but the additional bureaucracy and costs involved will deter much important public health research. The law: In Victoria, public and private hospitals and their employees have a statutory duty of confidentiality under section 141 of the Health Services Act 1988 (Vic). There is an exception when the patient consents (s 141(3)(a)), but, in Carapetis et al's study, patients cannot be approached until the laboratory gives identifying information. Information may be divulged for medical research without patient consent if an ethics committee "established under the by-laws of the agency" has approved "the use to which the information will be put and the research methodology" (s 141(3)(g)). The giving of information must also accord with Health Privacy Principle (HPP) 2.2(g) in the Health Records Act 2001 (Vic): it must be necessary and "in the public interest"; it is impracticable to seek consent; identifying information is needed; identifying information will not be published; and it must conform with the Guidelines of the Health Services Commissioner.2 The federal Privacy Act 1988 (Cwlth) contains similar provisions.3 Options for change: The Health Services Commissioner has power to issue guidelines varying the subparagraphs of HPP 2, and even to lessen the level of privacy protection, if it is in the public interest to do so.4 However, guidelines cannot override the requirement in the Health Services Act that projects must be approved by the ethics committee "established under the by-laws of [each] agency". There are four options for change: The Health Services Act could be amended so that approval of one human research ethics committee is sufficient. The Secretary of the DHS could prescribe more diseases as notifiable,1 so that information is available centrally, and access could be authorised by the DHS Ethics Committee. The Secretary could request information from pathology laboratories for public health research and supply that to the researchers (laboratories would be protected under section 137 of the Health Act 1958 [Vic]). Institutions could amend their by-laws — or ethics committees could adopt a policy — that the institution will follow the approval of the DHS Ethics Committee in public health research.5 The last seems the simplest option, but historically this approach has not been favoured in multicentre trials in Australia.

Loane LC Skene

To the Editor: Diabetes is a leading cause of morbidity and mortality in Australia, with 50% of cases remaining undiagnosed.1 Consequently, the Australian National Diabetes Strategy has early detection of diabetes as a key priority.2 We undertook a study to determine the prevalence of abnormal glucose metabolism (impaired fasting glycaemia [IFG] and diabetes) in patients presenting in the fasted state for endoscopy or colonoscopy at a metropolitan teaching hospital. We used the definitions of abnormal glucose metabolism outlined by the World Health Organization in 19993 and published in a position statement in the Journal in April 1999.4 Two hundred and twenty-four patients gave informed consent and participated in the study, comprising 126 men and 98 women. Mean age (SD) was 75.1 years (6.9) for men and 60.9 years (17.6) for women. Twenty-four participants (11%) had known diabetes. The remaining 200 patients had fasting venous plasma glucose levels determined (Box). Patients with abnormal glucose metabolism (fasting plasma glucose level > 6.1 mmol/L) were offered further testing with a 2-hour oral glucose tolerance test (OGTT) after a 75 g glucose load. Nine patients initially classified with IFG had diabetes based on OGTT results. No patient classified with diabetes on initial testing was subsequently classified as not having diabetes by the OGTT. The overall prevalence of undiagnosed diabetes was 7% (15 patients). We demonstrated a high prevalence of abnormal glucose metabolism in a group of predominantly elderly patients presenting for gastroenterological procedures. Furthermore, subsequent investigation of these patients revealed that a substantial proportion who were classified with IFG on initial screening were classified with diabetes based on 2-hour OGTT results, highlighting the importance of this test in diagnosing diabetes. It is likely that we underestimated the prevalence of abnormal glucose metabolism, as OGTT was not performed in all patients. This is supported by results of the AusDiab study that revealed a high prevalence of abnormal glucose metabolism in older patients — 37% of those aged 55–64 years, 47% of those 65–74 years, and 53% of those 75 years and over.1 National Health and Medical Research Council guidelines suggest that all patients with a fasting plasma glucose level of 5.5–6.9 mmol/L be referred for OGTT.5 Based on this suggestion, an additional 28 patients in our study group would have had an OGTT. Measurement of fasting venous plasma glucose level is safe, relatively simple and inexpensive. Patient presentations in the fasted state for investigations and procedures provide an ideal opportunity for screening with this test. Patients with abnormal results should be referred for further testing with repeat fasting glucose determination or OGTT. This process may be facilitated by involving patients' general practitioners. Results of fasting plasma glucose tests in 224 patients presenting for gastroenterological procedures Fasting plasma glucose level Normal (< 6.1 mmol/L) 172 (77%) Impaired fasting glycaemia (≥ 6.1 mmol/L, < 7.0 mmol/L) 22 (10%)* Diabetes (≥ 7.0 mmol/L) 6 (3%)† Not tested (known diabetes) 24 (11%) * Diabetes was confirmed on subsequent oral glucose tolerance test (OGTT) in nine of these patients (four refused further testing). † Diabetes was confirmed on subsequent OGTT in all six patients.

Anthony T Zimmermann · Stephen N Stranks · Sally L Gall · Geoffrey S Hebbard

To the Editor: Thank you to McVeagh1 for highlighting some more of the amazing scientific evidence regarding the benefits of breastfeeding. It is extremely important to continue to emphasise the benefits to mother and child in order to strengthen the individual's resolve and the community's support for breastfeeding. However, my concern is whether the question "Is breastfeeding best practice?" should ever be posed in the first place. Do our natural physiological processes now need to be supported by an evidence base and scrutinised in terms of whether they conform to notions of "best practice"? And should the question about choice between breastfeeding and artificial feeding continue to be asked? McVeagh also posed the question, "Is there justification in the argument that women are being pushed too hard to breastfeed?". Can there ever be too much encouragement given to women to provide nutrition and nurturing hand-in-hand to their baby? We must keep emphasising that breastfeeding is not only about good nutrition, reduction in childhood obesity and other measurable health outcomes. Surely there must remain some areas in our lives that do not require evidence and scientific support. Breastfeeding is about loving and nurturing a baby. It is about human relationships. When one experiences a newborn latching on to feed, the clearly felt surge of hormones from breast to brain, the physical expression of these hormones as a palpable "let-down" reflex and the incredible sight of milk rushing from the breast on demand, we do not need science to tell us that this is one of life's most amazing and wonderful experiences, nor to confirm what breastfeeding mothers innately know to be best practice.

Sandra L Neate

In reply: I thank Neate for her comments and for challenging the need to ask "Is breastfeeding best practice?". I appreciate her sentiment that there is more to infant feeding than nutrition and health. However, while there are mothers who don't find breastfeeding pleasurable or easy and are deciding how long to persist; while there are mothers who opt not to exclusively breastfeed for six months or to wean before a year of age; while mothers' advisors prescribe solids or complementary feeds or weaning for myriad problems without evidence for effectiveness beyond a placebo effect; while some believe that the disadvantages of not breastfeeding only apply to infants in developing countries; while there are commercial interests promoting products that undermine exclusive breastfeeding; while the Australian government has not fully implemented the recommendations of the World Health Organization Code and subsequent resolutions;1 while health professionals are receiving "educational material" implying that a new additive makes commercial infant formula more like human milk; and while the scientifically minded among us just need to satisfy our curiosity, we need to know to what extent it matters if an infant is breastfed at all, breastfed exclusively, or breastfed for longer periods. Thank you for challenging the question. The weight of the evidence is such that the real question is not "Is breastfeeding best practice" but "By how much?".

Patricia McVeagh

To the Editor: The working group responsible for the recent chronic fatigue syndrome (CFS) guidelines needs to be congratulated for producing a sensible and well balanced document in a most controversial area.1 Larkins and Molesworth have contributed a somewhat predictable response.2 Some sufferers of CFS can be characterised by their capacity to react strongly to the suggestion that psychological factors may be involved in the pathogenesis of their condition.3 From the perspective of the consultation-liaison psychiatrist, their response can be written with the comments on physical and psychological issues substituted for one another. Hence it can read (1) there is no current evidence that the syndrome has a specific physical origin, and (2) there is evidence that a range of psychological issues occur in people with CFS, although it remains unclear whether these changes are primary or secondary. The mental health movement has worked hard in recent times to reduce the stigma associated with psychiatric conditions. The sufferers of chronic physical illness now accept the importance of looking after their emotional health as well as their physical well-being. Enlightened CFS sufferers and support groups accept the links between physical and psychological morbidity and do not mindlessly exclude the latter. There is ample evidence that cognitive–behavioural strategies and graded exercise programs assist those with CFS, and psychiatrists are skilled in providing these treatments.4

James D Hundertmark

To the Editor: The process of destigmatising chronic fatigue syndrome (CFS) is not advanced by either limiting enquiry to "acceptable" sciences or increasing the stigma already experienced by people with other neuropsychiatric disorders. Contrary to its intent, and in contrast to the recently published Royal Australasian College of Physicians (RACP) guidelines,1 the recent statement by the immediate past president of the RACP and the Chairman of the ME/Chronic Fatigue Syndrome Association of Australia2 is in danger of increasing the stigma for both people with CFS and people with other common mental disorders. Unfortunately, key propositions in their letter ("There is no evidence that the illness is primarily psychological in origin") are clearly at variance with the tone of the guidelines (see Box 1.5, p. S31; Box 1.7, p. S32; and, "Management" summary, p. S38). Their letter reinforces the classical "dualistic" and rather simplistic "biological" approach (eg, "There is significant evidence of a range of biological abnormalities occurring in people with CFS"). Unwittingly, it colludes with community-based beliefs that mental health problems are "not health",3 and often imaginary or under the voluntary control of the patient.4 There is no doubt that people with CFS share many experiences with people with other neuropsychiatric disorders. They both have daily experiences where their credibility is challenged, their disability is minimised and their needs for appropriate medical management are not met. Australian research and best practice have been recognised internationally for emphasising the integration of psychological, psychiatric and biological factors and respect for the experiences of persons with these debilitating disorders.5 Unfortunately, the major advances captured in the guidelines may now be undermined if the RACP is perceived to be backing away from supporting appropriate psychological assessment and provision of effective "psychological" treatments (such as cognitive–behavioural therapy and physical rehabilitation approaches). Similar equivocation has left clinical guideline processes in the United Kingdom in disarray.6 As demonstrated recently, prolonged fatigue syndromes are common in the Australian community, and the vast majority of those who seek healthcare services have concurrent depression or anxiety.7 Real progress towards destigmatisation, meaningful research progress and improved health services for people with CFS will only occur when the field is mature enough to deal with the clear relevance of psychological factors. Instead of rejecting "psychological factors" and associated treatments, relevant professional and consumer bodies should now join with the broader community movement towards increased community awareness of common neuropsychiatric disorders, genuine understanding of their (genetic, "biological", psychosocial and personal) causes and provision of effective (pharmacological and psychological) treatments.8

Ian B Hickie

To the Editor: In the recent letter from Larkins and Molesworth1 various statements are made on which I would like to comment. From time to time everyone becomes physically or mentally exhausted, whether or not it is related to activity. For some people this exhaustion becomes disabling. They deserve understanding and sympathy. We must do everything we possibly can to assist them to recover and to try to find possible causes. Larkins and Molesworth acknowledge that chronic fatigue syndrome is a serious, disabling illness. When does ordinary exhaustion become disabling? I would agree that at this stage there is no clinical evidence that the condition is primarily psychological. Nor is there evidence that it is primarily physical. There may be a mixture. What is the "significant evidence" of a range of biological abnormalities occurring in people with CFS? What are these biological abnormalities and what physiological evidence is there for each one of these abnormalities to produce fatigue? Larkins and Molesworth state that treatment plans should be "within the capabilities of the patient": is there evidence to indicate that stimulating each patient to do just that little more each day will do harm? It was stated that scientific evidence of the aetiology, pathology and treatment is grossly deficient. It is in fact absent. There is no evidence at all. Research is certainly required. One of the problems is that, as soon as a medical advisor informs a patient that investigations have shown no serious abnormality, the patient often goes away and says to himself or herself or family that the "doctor said there is nothing the matter with me and that it is all in my head". Nothing could be further from the truth. Something is the matter and it is up to us to find it out.

Donald D Beard

In reply: We thank the writers for their comments on the CFS guidelines1 and our joint letter about these guidelines.2 Hundertmark remarks on the interplay between physical and psychological factors in morbidity associated with CFS. We trust that our letter in no way contradicts this. Similarly, the inferences that Hickie drew from our letter are not supported by the text of the letter. Far from undermining the guidelines, our letter had the full support of the convenor of the working party responsible for the guidelines. As clearly discussed in the guidelines, in the absence of specific diagnostic tests it is likely that a range of factors may contribute to the pathogenesis of CFS. Assumption of a primarily "psychological" pathogenesis is as unjustified as assumption of a primary "physical" basis. There are "abnormal" test results in many people with CFS, including abnormalities of the hypothalamic–pituitary–adrenal axis and some abnormalities of immune function. As stated, it is controversial whether such abnormalities are primary or secondary. While cognitive–behavioural therapy with graded exercise is effective in some patients, the guidelines outline the deficiencies of the evidence which "significantly limit the generalisability of the findings". As the guidelines indicate, and as is supported by our letter, treatment should be designed in partnership with the patient, and tailored according to the patient's capacity and response. Finally, as implied by Beard's letter, we restate the need for further research into the aetiology, pathology and treatment of CFS. We believe that effective progress in the management of this complex and mysterious illness will be best achieved by positive and cooperative rather than adversarial relationships between those suffering from the condition and the doctors and researchers attempting to help them.

Richard G Larkins · Simon R Molesworth

To the Editor: Bolin et al,1 in their editorial accompanying articles by Yusoff et al2 and Bampton et al,3 took the opportunity to make their case for endoscopic screening for colorectal cancer. We believe that their editorial is seriously misleading. 1: It is misleading to suggest that the 27 case–control and cohort studies in the meta-analysis by Johns and Houston4 stratified the index case by age at diagnosis. The 2.25 risk quoted by Bolin et al refers to the overall risk of first-degree relatives in families with one affected relative. In those studies in which age was stratified in the meta-analysis, there is a spectrum of risk, with families with onset of bowel cancer at an older age having lifetime relative risks much less than the average. A subanalysis of seven studies with age stratification showed the risk to be 1.82 (95% CI, 1.47–2.25), where the index case was over 59 years at diagnosis. Whether a 1.8-fold risk elevation warrants colonoscopic surveillance could be debated. "First do no harm" is an important axiom in well-patient screening, so one should aim for an order of magnitude of benefit over risk, which in this situation is not secured until the patient being screened is older than the suggested 40 years of age. 2: The recommendation that colonoscopic follow-up of patients with only small, tubular, distal adenomas can be at less frequent intervals is not based on the US National Polyp Study,5 as suggested in the editorial. It is based on the large cohort study of Atkin et al,6 who reported that patients with this finding were actually at below-average risk (relative risk, 0.5) for subsequent colorectal cancer after prolonged follow-up. This occurred despite the inevitable "miss rates". The editorial by Bolin et al handles this issue unconvincingly. The main message of the US National Polyp Study5 was that follow-up (except in exceptional circumstances of numerous polyps, or incomplete removal of malignant polyps) is not needed at 12 months — after 3 years is adequate. The National Health and Medical Research Council guidelines extend this to 4–6 years in the low risk groups, as defined by Atkin et al.6 The Atkin et al data, however, are only Level 3 evidence. 3: Bolin et al1 completely miss the point about pilot programs of screening with faecal occult blood testing (FOBT). There is no intention to confirm evidence of mortality reduction. The pilot studies are neither designed to, nor capable of, doing this. Mortality reduction from FOBT is well established on Level 1 evidence. The pilot studies are in place to answer the very practical questions of how to implement large-scale screening programs in Australia; what logistic and resource issues are involved; how compliance and acceptance will best be secured; and how to approach difficult-to-access populations (perhaps with low health insurance rates as distinct from populations well supplied by colonoscopy services). The central issue in advocating a menu of options to individuals versus more prescriptive screening (based on FOBT) is whether the height of the scientific bar should be at Level 1 evidence or modestly robust Level 3 evidence (flexible sigmoidoscopy) or the less robust Level 3 evidence (colonoscopy), complemented by certain appeals to logic (carefully crafted in the editorial). Medical initiatives based on less than Level 1 evidence have a history of being shown to be wrong, and the concept of colonoscopic surveillance is not immune from this outcome. Where a significant outlay from the public purse is involved, the Federal Government is being appropriately prudent in acting on Level 1 evidence.

Finlay A Macrae · Geoffrey S Hebbard

In reply: Macrae and Hebbard fail to grasp the concept that colorectal cancer is the only potentially preventable cancer in men and one of the two preventable cancers in women. In any discussion about screening options, this fact must be kept clearly in focus. In terms of surveillance of first-degree relatives, we doubt the available evidence is of sufficient quality to be certain whether the absolute risk is 1.82 or 2.25. In either event, we would advocate colonoscopic surveillance. We would, however, agree with Macrae and Hebbard on the importance of safety issues. Elsewhere we have advocated confining the performance of colonoscopies to endoscopists with Conjoint Committee Accreditation, and ensuring that the procedures are undertaken in accredited, suitably equipped facilities.1 We find it difficult to understand why Macrae and Hebbard believe that "the main message of the US National Polyp Study2 was that follow-up . . . is not needed at 12 months". Showing a reduction in expected cancers of 90% seems to us a far more important finding. We would, however, point out that our editorial does not advocate routine colonoscopic follow-up at 12 months. In relation to the pilot faecal occult blood testing (FOBT) studies, we believe that Macrae and Hebbard have missed the point. They advocate delaying colorectal cancer screening for a further five years to await the results of studies which, many believe, will be both outdated and probably inconclusive. Their continued inflexible stand is one that is being rejected by a rapidly increasing number of countries, including the United States, Germany, Italy and the recently formed Global Alliance for the Prevention of Digestive Cancer. Colorectal cancer is the commonest cause of mortality in both non-smoking men and women, with a death from this disease every two hours in Australia. We suggest that introducing screening is far more urgent than Macrae and Hebbard advocate. We re-emphasise the point that individuals should, if they wish, be provided with the opportunity of selecting a screening program from a menu of options chosen after discussion with their primary medical carer.

Terry Bolin · Alistair E Cowen · Melvyn G Korman

To the Editor: I am writing in response to the letter from Zardawi in the 19 August 2002 issue of the Journal.1 Zardawi suggests that radiologists and pathologists should not talk to patients, and that their contract is with the referring doctor, not with the patient. On both counts he is mistaken. Patients who are worried and anxious are certainly in need of some communication with the doctors carrying out their investigations. Most doctors of experience will know what is appropriate by way of conveying any results and what should be left to the patient's own doctor. Only those in bondage to corporate medicine will require a formula to instruct them in correct behaviour. That there is a contract with the patient is attested by the many cases of litigation against radiologists and pathologists. Of course, it is more efficient if the doctor does not speak to the patient, as valuable time is saved, and even more efficient if the doctor's staff do not speak to the patient either. This is common practice, as reported daily by patients and confirmed by my own recent experience. Nothing was communicated to me except that if I wished to rewrite my physician's referral to indicate that I had a palpable lump (which I did not) there would be a Medicare rebate, and that otherwise there would not, and I would thus have to pay the full amount. I declined the offer. I then waited two weeks to know that my results were normal. Some patients report that they will travel 20 km across the city to visit a practice where the staff look up and speak when patients enter, and where the doctor is not too busy to speak to them. No doubt such "inefficient" practices will disappear in time. The case of nuclear medicine differs in that the Health Insurance Commission schedule of fees requires the physician to see and assess the patient and to supervise the procedure in order for a benefit to be legally payable. The nuclear medicine physician is therefore in a position to know what is appropriate to communicate to the patient. Most patients are grateful for the opportunity to discuss the findings and to understand the implications of what has been found. In the case of serious abnormalities, such as pulmonary embolism, it is imperative that the patient be made aware of the importance of the findings and the need for immediate treatment.

Josephine C Wiseman

To the Editor: A 63-year-old woman presented with polyuria, polydipsia, lethargy and vomiting. Two weeks previously, she had been diagnosed as having diffuse scleroderma with possible interstitial lung disease, and had started taking 50 mg prednisolone daily. Her past history included diabetes, hypertension, hypercholesterolaemia and β-thalassemia trait, and her other medications were metformin, glibenclamide, quinapril and amlodipine. Examination revealed blood pressure 150/60 mmHg, a loud second heart sound with no murmurs, and late inspiratory crepitations at lung bases. Her serum creatinine concentration was 270 μmol/L (compared with 100 μmol/L two weeks previously) and serum glucose concentration was 26.5 mmol/L. Treatment by the admitting doctor included insulin, rehydration, and cessation of prednisolone (given hyperglycaemia) and quinapril (secondary to acute renal impairment). She developed a fever and cough, with bilateral pneumonia, which was treated with intravenous ceftriaxone. Despite normotension, concern regarding scleroderma renal crisis (SRC) was raised. On Day 12 of admission, when renal failure had developed to the dialysis-dependent level (serum creatinine level, 690 μmol/L), quinapril was recommenced for its proposed renoprotective effect and haemodialysis was initiated. Microangiopathic haemolytic anaemia (haemoglobin, 7.2 g/L) was diagnosed, with fragmented red blood cells (Box). Several months later, she continues on haemodialysis three times a week. Renal biopsy was not performed given the clinical picture of diffuse scleroderma and recent corticosteroid use with rapid development of renal failure — consistent with SRC. SRC is defined as rapidly progressive renal failure and/or new onset of malignant hypertension during the course of scleroderma, occurring in 15%–20% of patients with the diffuse variety.1 Risk factors include male sex, black race, and early diffuse scleroderma with rapidly progressive skin thickening.2 Precipitation of SRC by corticosteroid use, especially in normotensive patients, is well described, particularly with high-dose (>15 mg/day) treatment.2 Early diagnosis is critical because treatment may preserve renal function.3 Outcomes have improved with use of angiotensin-converting enzyme (ACE) inhibitors,2 which are thought to improve renal function by controlling the high renin levels seen in patients with SRC. About 61% of patients have a good outcome, with no or temporary dialysis.3 Predictors of poor outcome, despite ACE inhibitor use, include older age, male sex, higher initial serum creatinine level, and scleroderma myocardial disease.1 Eleven per cent of SRC patients remain normotensive and have significantly reduced 12-month survival rates.4 This may relate to delay in diagnosis of SRC. The use of high dose corticosteroids in patients with early diffuse scleroderma should be strongly discouraged, and intensive monitoring for SRC is recommended if low dose corticosteroids are required. Peripheral blood film, magnification x40 Changes of thalassaemia (microcytosis and hypochromasia) and microangiopathic haemolysis (fragmented red cells and spherocytes). 1. Spherocytes. 2. Fragmented red blood cells.

Anita T Y Lee · Simon Burnet

To the Editor: Comprehensive care has been shown to improve outcome in asthma management when it has four components — asthma education, self-monitoring, written self-management plans, and regular medical review.1,2 A recent Cochrane Review has explored the role of one of these components — written self-management plans — and concluded that there is "no consistent evidence that written plans produced better patient outcomes".3 Should this cause us to change our management strategies in Australian general practice? Does this mean that our patients are not able to care for their own asthma without our intensive assistance? These findings update a 1998 review of the role of written asthma management plans as part of comprehensive care in 1998: "In five studies which compared subjects who managed their asthma by self-adjustment according to individualised written plan with those whose medications were adjusted by the doctor, lung function data (FEV1 [forced expiratory volume in one second] and PEF [peak expiratory flow]) were significantly higher in the self-managed group."1 In Australian general practice, between 30% and 50% of patients are given a written asthma management plan.4 These plans form part of known beneficial comprehensive asthma care plans, such as the Six-Step Asthma Management Plan5 or the Asthma 3+ Visit Plan.4 The small number of available high quality trials for this most recent review led the authors to say, "Available trials are too small and the results too inconsistent to form any firm conclusions", and suggests that more trials are needed to produce a conclusive result.3 We should be careful not to lose the positive effects of improved chronic disease management in asthma by over-responding to this one review of one component of comprehensive care.

Andrew M Thornett · Jonathan W Newbury · Andre J Duszynski

Comment: A Cochrane systematic review identified the beneficial effects of planned asthma management and education that includes a written action plan.1 These findings have now been adapted for primary care and implemented as the Asthma 3+ Visit Plan. This involves a systematic assessment of asthma symptoms, lung function, and current treatment at each visit. Treatment and management skills are optimised and the patient is given written instructions on how and when to increase treatment when asthma deteriorates (a written action plan). A recent Cochrane review asked whether one can get the same benefits by doing less — by simply supplying a patient with a written action plan.2 The review found that the literature was inconclusive. This doesn't mean that written action plans are not effective; it means that there is not enough evidence to be able to answer the question. The result of "no evidence of effect" is completely different to "evidence of no effect".3,4 This is a crucial distinction, as many systematic reviews find insufficient evidence to be able to assess a treatment. This is a statement about our ignorance rather than a statement about whether a treatment works or not. The review also highlights the need to carefully evaluate the control intervention. For example, the control groups in two studies in the systematic review2 received regular medical review, with assessment of severity and optimisation of inhaled steroid therapy. It is not surprising that these studies found it difficult to identify any additional effect of an action plan. Cochrane systematic reviews conclude with recommendations for clinical practice that highlight effective treatments,1 and with recommendations for research that indicate where more information is needed.2 The review looking at just supplying patients with written action plans2 exemplifies the latter.

Peter G Gibson