Letters

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

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