Letters

To the Editor: The perspective by Williams and colleagues,1 based on analysis of guidelines hosted on the National Health and Medical Research Council (NHMRC) portal (http://www.clinicalguidelines. gov.au), highlights the need for a culture of transparency and disclosure to effectively manage conflicts of interest. With the current health reform agenda being dependent on the availability of clear and unbiased clinical guidance, the NHMRC continues to actively address this persisting challenge. In July 2011, new standards for guideline developers seeking NHMRC approval were released. The standards make it mandatory for guideline developers to publish all sources of funding for the guideline; to publish a complete list of all the people involved, including professions, organisational affiliation and role in the guideline development process; and to publish how potential competing interests are identified, managed and documented. A competing interest declaration must be completed by each member of the guideline development group.2 The NHMRC is committed to implementing management practices for improving transparency of the development of evidence-based health advice. We recently conducted public consultation on policies for identifying and managing conflicts of interest in relation to NHMRC committees and working groups who are developing guidelines. Submissions to the consultation will be taken into account for the finalised policies, to be released in 2012. The draft policies can be viewed at http://consultations.nhmrc.gov.au/open_public_consultations/conflict-of-interest. The NHMRC has also established the Australian Guideline Developers Network and holds national workshops to help guideline developers identify and manage issues, including conflict of interest, with the aim of reducing the variability in the quality of guidelines (http://www.nhmrc.gov.au/guidelines/nhmrc-initiatives-support-high-quality-clinical-practice-guideline-development). These strategies, combined, will strengthen the role of the NHMRC in supporting the translation of health research into trustworthy clinical guidance, in areas that will most benefit the health of the Australian population.

Warwick P Anderson · John McCallum

To the Editor: Since the claims made by Webber in his recent article1 were, in his own words, not based on any substantiated data, it is disappointing that the Medical Journal of Australia did not seek to contact either the Australian Society of Ophthalmologists (ASO) or the Royal Australian New Zealand College of Ophthalmologists (RANZCO) for comment. Certainly, considerable work can be done to improve the operation of Medicare. We are on record as having raised our concerns with successive governments.2 However, Webber’s generalised, sensationalist and unsubstantiated claims add nothing to constructive debate about Medicare. It is disappointing that the Journal would risk damaging its reputation, by choosing to publish a perspective without offering an alternative view to demonstrate balance and evidence, as one would expect in a peer-reviewed journal. Ophthalmology involves more than just removing cataracts, and while technology has made cataract procedures safer and less invasive, they remain complex and the technology very expensive.3 The RANZCO and ASO have worked with government through the Medicare Benefits Schedule Review to address concerns and shortcomings, as well as providing supportive evidence.4 On at least two occasions, we have offered revisions to the funding of treatment of macular degeneration that could save many millions of dollars in the health budget. Additionally, our proposal to reinvigorate the key subspecialty of paediatric ophthalmology has been accepted by government.

Arthur Karagiannis · William J H Glasson

To the Editor: Webber raises some well meaning points in his recent viewpoint article, some of which were taken out of context by the media.1 With respect to his comments on ophthalmologists, I would like to place on record some facts. The Access Economics ophthalmology practice costs survey,2 commissioned by the Australian Society of Ophthalmologists (ASO) in 2011, analysed the costs of delivering ophthalmic services for the financial year 2008–09. The report showed that the average overhead cost per full-time-equivalent ophthalmologist was $506 000, compared with $232 617 in 19993 — an average annual increase of 9%, during which time fees for ophthalmology items on the Medicare Benefits Schedule (MBS) increased by only 2.1% annually.4 Thus, the MBS items become increasingly irrelevant in the context of a small private ophthalmic business model. The cost to the taxpayer of a cataract procedure in New South Wales public hospitals is about $3500 (diagnosis-related group), compared with a Medicare schedule fee of $731 (item 42702). Thus, the procedure can be performed privately for about 20% of the taxpayer cost. Clearly, private surgery is a very efficient use of taxpayer money for an operation with a quality-of-life-adjusted score of about 30 times what is considered cost-beneficial.5 The average eye surgeon performs fewer than half the cataract procedures per week than the 20 which Webber anecdotally claimed (and then multiplied by the entire cost of the procedure, presumably including the theatre fee and prosthesis). Webber is to be congratulated for speaking his mind, but ought to factually balance his writings. The ASO encourages other craft groups to commission their own practice-cost surveys when fiction needs to be separated from fancy.

Peter M Sumich

To the Editor: The “thinking doctor’s” Journal has degenerated to one for doctor’s random thoughts. The commissioned and peer reviewed article by Webber1 was disappointing. For many disenfranchised colleagues, the usual whinge over a cuppa at the local meeting is now plainly inadequate after this Medical Journal of Australia offering. The unsubstantiated claim about billions in Medicare “wastage”1 was reckless. The implication that the current cataract surgery rebate was poor value and had never changed was just plain wrong. Since the introduction of the Schedule of Medical Benefits, cataract surgery now requires entirely different surgical skills, implants a lens, and requires expensive, sophisticated equipment (for examples, see websites2-4). Patients can now expect vastly improved vision without the need for full-time visual aids. The rate of significant sight-threatening complications is now less than 7 in 1000 — one of the lowest complication rates in surgery. The rebate was reduced by about 40% in 1987, 10% in 1996, and 12% in 2009. Even before the last reduction, the total cost provided a significantly better gain (that is, lowest cost) in quality-adjusted life-years than any other surgical procedure,5 something conveniently ignored by the then Health Minister Roxon when cutting costs. With more than 500 ophthalmologists performing over 200 000 operations a year, the statistical distribution will certainly include the few surgeons performing high volumes of procedures or charging high fees, as it does with any other procedure listed on the MBS. Webber’s implied generalisation is totally invalid, as the distribution tail in no way represents the average. I am afraid that Webber has only provided us with sloppy commentary and cheap shots — nice if you can get away with it, but it is poor editorial policy.

Nigel Morlet

To the Editor: Webber is to be congratulated for his concise statement of the ills of Professional Services Review (PSR) audit,1 but his estimate of multiple billions being wasted each year is unsupported by evidence. This remark has already been picked up by several of the nation’s daily newspapers, and well suits those of certain political persuasions. However, it is also essential that the operation of the PSR be subject to scrutiny. The past performance of the PSR must be examined — including the correctness and consistency of the information it uses, its investigative processes, the defence evidence it does and does not accept, and the available avenues of appeal. These issues are all of great concern to doctors who have come to the PSR’s attention. I note that the most recent edition of Medicare’s Forum promises more Medicare audits.2 The fun has only just begun.

A Stuart Reece

To the Editor: After our recently published article1 and subsequent criticism2 that shortages in benzylpenicillin were a “storm in a teacup”, we would like to detail the increasing number of drug shortages at John Hunter Hospital. Not only does this pose increasing costs to pharmacy but there are escalating threats to patient care. As part of our routine formulary management, records are kept on drug shortages, collected to communicate urgent pharmaceutical issues and not designed as a research tool (Box). All shortages recently experienced in this hospital have been in generic medicines, particularly injectables, although any drug is potentially vulnerable. There are shortages that recur; thiopentone has twice been in short supply in recent months, noradrenaline has had recurrent periods of short supply, and intravenous labetalol is currently critically low and has previously been discontinued by a supplier in Australia, requiring a new manufacturer to be found. At the time of writing, midazolam 5 mg/5 mL injection is in short supply despite there being three generic brands in Australia, suggesting that all products come from the same source. The shortages we are experiencing are similar to but less extensive than those described in the United States.3 However, our list is far from complete as we cannot detect suppliers’ shortages that are resolved before our hospital shelves are affected. Hospitals cope in the usual ways — stockpiling (which protects some networks and harms others), switching to alternatives where possible, and finding new suppliers. Not only does this directly compro-mise patient care, it has been shown that subsequent changes in formulary increase medication errors4,5 — not to mention the economic impact, which is not known in Australia but has been estimated to cost $216 million each year in the US.3 Governments in the US and United Kingdom are taking decisive action to rectify this problem. However, the issue remains unrecognised in Australia and the Therapeutic Goods Administration has indicated to the authors that monitoring shortages is not its legislative responsibility. In the interests of national health care security, this issue needs to be resolved immediately by the federal government. Urgent action must be taken to identify medicines that are “essential” and to safeguard their supply through all possible avenues to ensure short-term health care sustainability. Number of different medicines in short supply at John Hunter Hospital, 2006–2011

Robert Pearce · Simon Quilty · Jacqueline Kewley · Lisa M Harris

To the Editor: As an author, researcher and lecturer on the safety of drugs used in the obstetric setting for over 30 years — during which I participated in successive Medicines in Pregnancy Working Parties of the Australian Drug Evaluation Committee and Therapeutic Goods Administration (TGA) — I share Kennedy’s concerns about the alphabetical drug categorisation system currently used in Australia.1 I am also concerned that, since the demise in 2008 of the Prescribing Medicines in Pregnancy TGA Advisory Group (which provided ongoing external clinical expertise to the TGA), there has been a complete lack of action, preparation and consultation with external sources of expertise and experience by the TGA with regard to the safety of drugs used in pregnancy. Expert consultation would be invaluable in preparing for the overseas “game-changing” developments in labelling relating to safety of drugs used during pregnancy, as identified by Kennedy. These changes in labelling are primarily being driven in the United States, with the aim of providing definitive, well substantiated advice to patients and health professionals — advice that reflects the consensus of expert opinion in a way that the alphabetical system, by its inherent structural and functional limitations, is unable to do.

Ronald P Batagol

To the Editor: Kennedy highlights a major source of frustration for mothers and health professionals — the accuracy of information regarding the safety of medications in pregnancy.1 The current categorisation system is inaccurate and outdated. Labetalol, used safely throughout pregnancy to treat hypertension for more than 30 years, has a Category C label because atenolol was associated with intrauterine growth retardation in one study.2,3 Proton pump inhibitors remain in Category C despite large studies demonstrating their safety in pregnancy.4 Hydroxychloroquine is in Category D despite extensive use in pregnancy without any adverse effect.5 The present A to X system could be simplified to three categories — safe, uncertain and definite risk, with a brief description of the information available, together with the references on which the evaluation is made. This could be freely available online and regularly updated as new information is published. In addition, more rapid accumulation of evidence regarding the safety of newer medications in pregnancy and lactation is needed. At present, we rely on the publication of case reports and case series by single institutions. It would be valuable if a national or international database of de-identified information could be kept on mothers and babies who are exposed to drugs for which the safety is uncertain, so that outcomes may be followed, to better guide future parents and their health professionals regarding the safety of these medications in pregnancy and lactation.

Adam P Morton

In reply: As a practising physician, Morton clearly understands the issues faced by prescribers and consumers regarding drug categorisation in pregnancy.1 Currently, the Therapeutic Goods Administration provides no references for the data on which it bases its drug categorisations for pregnancy. It is therefore left to the conscientious prescriber to try to find the data (not always easy or obvious) and then attempt to interpret it in a clinically relevant way. The more narrative approach suggested by Morton is an improvement but would still need clinical context and interpretation for optimal use. The system proposed by the United States Food and Drug Administration (FDA) would provide appropriate referenced data so that clinicians and consumers could see the latest available evidence (and not, as Morton points out, just the limited studies performed up to 30 years ago) about the safety (or otherwise) of medication to enable rational decision making regarding medication use during pregnancy and breastfeeding. The FDA’s proposed new labelling would include contact details of any pregnancy registries, if applicable, for the agent in question.2 At present, there are over 20 pregnancy registries collecting prospective data on the effects of exposures, including antiepileptic drugs and vaccines, as well as registries for pregnant women being treated for chronic medical conditions such as rheumatoid arthritis and HIV/AIDS.3 It is unfortunate that Australian regulators have not properly discussed these issues with interested professionals in the past few years. Even if we cannot remain world leaders in this field, it behoves us to at least embrace innovation occurring in other parts of the world.

Debra S Kennedy

To the Editor: The decline in the number of National Health and Medical Research Council (NHMRC) scholarships awarded to general practitioners over the past 9 years reflects continuing problems in Australia’s capacity to produce a good base of general practice researchers. Since 1998, 20 GPs have received NHMRC doctoral scholarships; nine of these were granted in 2002 and six were granted after 2002....

Gerard F Gill

To the Editor: I would like to add my perspective, after nearly 50 years of experience in Australian medicine, to the very welcome articles by Moynihan1 and Webber.2 A few months after Medibank (Mark I) was launched in 1975, a colleague and I wrote a satirical article called “How to rob Medibank blind”.3 We deliberately wrote this article anonymously, so that it could be judged on its merits, and not by its authors. It was picked up by the Sydney Sunday Telegraph and featured across its middle pages. The responses of the then Minister for Health, Ralph Hunt, and Australian Medical Association (AMA) president, Lionel Wilson, were, to paraphrase their words, “doctors are not like that!” This view was shared by Medibank architect, economist John Deeble, when I asked, 20 years later, why he and his co-architect Richard Scotton had designed “a mechanism with an accelerator pedal but no brakes”. They had, he said, not thought it necessary. Around that time, on behalf of the AMA, I advised on the restructuring of the Professional Services Review (PSR). I had been fortunate, meanwhile, to have chaired Professional Standards Committees of the New South Wales Medical Board, and to have sat on the bench of the NSW District Court Medical Tribunal, looking at alleged poor professional conduct. This opened my eyes to the small number of doctors whose standards were poor overall, and led to the Board’s performance assessment program. Many had also been investigated by Medibank or Medicare. Instead of having the PSR chasing illusionary and indefinable “over-servicing” by general practitioners (curiously, specialists were almost never investigated), I suggested peer review, whereby trustworthy, practising GPs or relevant specialists could advise on whether or not a doctor’s pattern of practice was inappropriate. This could be judged on an overall view of their work, much as was being done in the NSW Board’s Performance Program. Another decade later, as Chairman of the Doctors Health Fund (then the AMA Health Fund), I attended a small dinner in Melbourne with the chairmen of a few restricted membership funds and the then Minister for Health, Tony Abbott, who asked me to sit next to him. I asked pointedly how he could justify commercial corporations’ continuing to make profits for their shareholders out of Medicare benefits which were supposed to reflect the value of a doctor’s professional services. How could there be so much fat in the system that these corporations could cream off their substantial profits? His disappointing response was that it was too difficult to do anything about it. Webber is correct — both sides of politics are to blame.

Peter C Arnold

To the Editor: An ethical concern that was raised by Conway in his article supporting the freedom to practise in accordance with conscience1 related to the problems that arise when patients — specifically children — are unable to express a considered opinion on any conflict between their clinicians and their legal guardians about their best interests. Parents know their child best, are responsible for continuing care of the patient (including during any adverse effects of treatments) as well as of any other dependants. However, they may also be guided more by strongly held beliefs than by the views of clinicians on the best interests of their child. The law gives parents considerable rights and obligations to make decisions in the best interests of their children, but the law also recognises that children have rights, independent of the parents. When children are able to form and express opinions, these are considered; when they can’t, they are dependent on others to promote their interests. Within this legal framework of competing rights, the solution can only be a legal one, as occurred with the patient in Conway’s example.1 Clinicians have to be prepared to go to court to put their case for the best interests of the child, and then accept the legal decision with good grace, however personally distressing. This is just another example in medicine of the need for all to work with less than desirable outcomes. And one must always remember that not complying with a court order is an option — with consequences — that may seem ethically justifiable to a clinician or parent.

William R Adam

To the Editor: In a recent Opposing Views article, Conway claims that doctors should be able to practise according to their personal values,1 but the argument he uses is not persuasive. The ethical dilemma in the case is not characterised correctly. Autonomous choices can be made while treatment options, based on scientific knowledge, are available. If there are no medical options to improve the outcome — if we are at the very limits of medicine — there is no duty to provide anything other than palliation. In other words, the “do no harm” principle takes precedence over the duty to treat the patient according to his or her needs. Under these circumstances, refusing to “treat” is to practise with medical knowledge and the comfort of the patient (in Conway’s example, a child) in mind, regardless of the parents’ wishes. There is no ethical dilemma in that sense. In fact, the dilemma doctors have is not clinical, but a professional one created by the court order compelling doctors to continue futile treatment, causing unnecessary discomfort that obviously conflicts with the “do no harm” principle. Hence, Conway’s case does not support his argument. In addition, his argument may lead to the violation of patient wellbeing and of professional values. The moral problem related to defining a space for personal values in medical care is that they may conflict with professional values, legitimising discrimination. Then it would be nearly impossible to criticise doctors and institutions that refuse abortion, do not examine patients of the opposite sex on religious grounds, and refuse to operate on HIV-positive patients or to treat people with different political affiliations. It would be hard to call that kind of environment a “healthy diversity”. As well as defending the right to health, we should protect the professional value of non-discrimination to preserve trust between medicine and society. In fact, in order to “safeguard against abuses of power, error and exploitation in medicine”,1 we have already established universal professional codes, instead of leaving the stage to the relativity of personal values.

Murat Civaner

To the Editor: In his Opposing Views article, Travis claims that fee- for-service (FFS) “provides the best transparency, accountability and incentive for everyone”.1 However, FFS models reward volume and intensity, rather than quality of outcomes. Evidence suggests that FFS results in increased numbers of patient visits, investigations and procedures,2 which contribute to inflation in the cost of health care.3 Further, an FFS model is “transparent” only on a most superficial level, because doctors are paid for the number of items they deliver. What matters most is transparency about whether the care being delivered to patients is in those patients’ best interests. Patients do not have the same grasp of technical information as their doctors. They assume, with justification, that most doctors perform their clinical practice not primarily to serve their own incomes, but patients’ best interests. Regardless, it is undeniable that the reward structure associated with an FFS system provides powerful incentives for delivering more services, with clinicians subsequently inducing increased demand for medical services.4 On the other hand, the problem with purely salaried providers is that they are more likely to underservice their patients, with an increase in the length and a decrease in the number of consultations.2 Clearly, neither of these payment systems is optimal for driving quality or efficiency in resource use. The ideal outcome from health care reform would be one in which the focus is on delivering high-quality, efficient care to patients, rather than high-quantity care. In designing the optimal payment structure, the aim should be to align the incentive with the quality and appropriateness of the care that is delivered — to reward doctors for their efforts to provide good health outcomes for patients.3 Our current health system provides much lower rewards for the doctors who practise much of our preventive care (general practitioners and physicians) than it does for procedural specialists. This may not be the most cost-effective strategy, and part of the debate about how doctors are paid should be directed at this imbalance. There has been experimentation with “capitation combined with pay-for-performance” or “shared savings” models, which are promising attempts to find the best balance of incentives for cost control and quality improvement.5

Matthew H R Anstey · Stephen P Gildfind

To the Editor: In 2009, we calculated that an estimated 50 405 prison inmate separations occurred in Australia in the 2007–08 financial year,1 and argued that the significant mortality risks associated with release from custody necessitated accurate and routine dissemination of such information. We believe this is still required, and that reporting the most current estimate of inmate separations may help facilitate better through-care and post-release health service provision. Our previous estimates have been used to contextualise discussions of prisoner health,2 estimate the number of post-release deaths,3 and advocate for needle and syringe programs in Australian prisons.4 Consistent with the approach detailed elsewhere,5 we estimated the number of inmate separation episodes occurring in Australia for the financial year 2008–09, using benchmark data from public documents on the website of each state and territory government department responsible for prisons. We attempted to obtain the total (ie, sentenced and on remand) number of inmates released from prison in 2008–09. This figure was available for Victoria (5458), South Australia (4489) and the Northern Territory (3078). For New South Wales, data could only be obtained for separations of sentenced prisoners (8941). To adjust for separations of prisoners on remand in NSW, we assumed that separations of sentenced prisoners comprised 38% of all separations, reflecting the ratios of separations in other jurisdictions. Hence, the total estimated number of separations in NSW was 21 468. Adding this to the other three figures gave a total of 34 493 separations in four jurisdictions that collectively hold 63% of the national prisoner population. A multiplier of 1.59 (1/0.63) was applied to this figure to produce a national estimate of 54 751 prison separations in 2008–09, each of which is associated with a significant increase in risk of death. Our estimate represents an 8.6% increase on the estimate from the previous financial year. This substantial increase suggests that routine reporting of actual incidents of separation, as well as numbers of unique individuals released from prison, remains vital to the provision of adequately scoped and resourced post-release health and welfare services in Australia.

Kristy A Martire · Sarah Larney

To the Editor: Significant mortality and morbidity occur among pedestrians involved in road traffic incidents.1 The National Road Safety Strategy 2001–20102 aimed to achieve a 40% decrease in pedestrian fatalities in Australia through road safety measures, including urban speed limit reductions. To assess the impact of such measures, we examined the long-term mortality trend in pedestrians presenting to an inner Sydney major trauma centre and determined whether incident location was a predictor of major trauma (defined as in-hospital mortality, intensive care unit admission and/or Injury Severity Score > 15). We identified 1944 trauma registry records of adult patients admitted to Royal Prince Alfred Hospital between 1992 and 2010 as the result of a pedestrian incident within the hospital’s catchment area, excluding transfers from other facilities (Box 1). Incident locations noted on clinical and ambulance records were classified as city or suburban according to current City of Sydney local government area boundaries. Population data were obtained from the Australian Bureau of Statistics. From 1992–1994 to 2007–2009 (population data for 2010 were unavailable at time of analysis), the age-adjusted mortality rate fell from 6.25 to 2.31 per 100 000 population (Box 2), a relative decrease of 63% (incidence rate ratio [IRR], 0.94; 95% CI, 0.91–0.98; P = 0.003). Negative binomial regression analysis showed that the reduction in mortality was statistically significant for incidents in the city (IRR, 0.91; 95% CI, 0.86–0.96; P = 0.01) but not suburban areas (IRR, 0.96; 95% CI, 0.92–1.00; P = 0.09). Multivariable logistic regression showed the odds of major trauma were 70% higher for suburban incidents than city incidents after adjusting for age, sex and time of presentation (after hours and weekends) (adjusted odds ratio, 1.7; 95% CI, 1.1–2.6; P = 0.02). The decrease in pedestrian mortality appeared most prominent after 2003, around the time the urban speed limit was reduced from 60 km/h to 50 km/h, and to 30–40 km/h in areas with high pedestrian activity.3 The 10 km/h speed limit reduction alone is estimated to have resulted in a 6% decrease in pedestrian fatalities.4 However, the trend appears to be limited to city incidents, with an annual reduction of 10% in the city versus 3% in suburban areas (Box 1). The observed improvement in outcomes, particularly in the City of Sydney, is likely a result of speed-limit reductions, drink-driving laws and improvements in clinical care. However, more needs to be done to protect pedestrians in suburban areas. 1 Baseline characteristics and outcomes of pedestrian incidents City (n = 883) Suburban (n = 1061) P Male 561 (47%) 625 (53%) 0.04 Median age (IQR) 34 (24–53) 46 (29–67) < 0.001 Median ISS (IQR) 4 (2–9) 5 (4–17) < 0.001 ICU admission 124 (11%) 241 (19%) < 0.001 Median hospital length of stay, days (IQR) 3 (1–9) 5 (1–13) < 0.001 Major trauma* 175 (20%) 336 (32%) < 0.001 Deaths 32 (4%) 76 (7%) 0.001 Crude mortality rate (95% CI)† 1992–1994 2.1 (− 0.4, 4.7) 1.5 (− 0.03, 3.0) 1995–1997 1.2 (− 0.6, 3.0) 2.3 (0.4, 4.4) 1998–2000 0.9 (− 0.6, 2.4) 2.0 (0.2, 3.8) 2001–2003 1.6 (− 0.3, 3.6) 1.5 (− 0.03, 2.9) 2004–2006 0.3 (− 0.5, 1.2) 1.3 (− 0.09, 2.7) 2007–2009 0.3 (− 0.5, 1.2) 0.9 (− 0.2, 2.0) Annual change over 18 years‡ − 10% − 3% IQR = interquartile range. ISS = Injury Severity Score. ICU = intensive care unit. * ISS > 15, requiring ICU admission, and/or death. † Rate per 100 000 population among adult pedestrians averaged over 3-year periods. ‡ Calculated using the formula: change (%) = (P1/P01/n − 1) × 100 where n is number of years observed − 1, P1 is the final average rate and P0 is the initial average rate. 2 Age-adjusted mortality rate per 100 000 population for adult pedestrians, 1992–2009* * Age standardised to Australian Bureau of Statistics 2006 census data (bars represent 95% confidence intervals).

Matthew Oliver · Michael M Dinh · Susan Roncal · Soufiane Boufous · Bernardino Branco · Christopher M Byrne

To the Editor: Tenofovir disoproxil fumarate is a nucleotide analogue reverse transcriptase inhibitor that is used in Australia as first-line antiviral treatment for HIV infection.1,2 Tenofovir may be nephrotoxic, particularly affecting proximal tubular function.3 We report a case of tenofovir-associated Fanconi syndrome, which demonstrates the need for vigilance in patients taking tenofovir. A 17-year-old rurally residing boy with perinatally acquired HIV infection presented to a tertiary referral hospital with renal impairment. His serum creatinine level had been normal 4 years previously. He had had severe leg pain and weakness for over a year, and was unable to mobilise without a walking frame. Because of his illness, he had stopped studying. He had commenced antiretroviral therapy in 1996, when he was 3 years old, and at presentation was taking tenofovir plus emtricitabine and lopinavir plus ritonavir. Follow-up with his local clinician was intermittent. The patient’s HIV viral load was undetectable, and he had a CD4 count of 0.62 × 109 cells/L. His serum creatinine level was 150 μmol/L (reference interval, 60–110 μmol/L) and his estimated glomerular filtration rate (eGFR) was 52 mL/min/1.73 m2 (normal value, > 90 mL/min/1.73 m2). He had all the features of Fanconi syndrome — hypophosphataemia with renal phosphate wasting, glycosuria, aminoaciduria, a reduced serum uric acid level and proteinuria (1.93 g/day). He also had hypokalaemia and acidosis, and his urine tested positive for β2-microglobulin. Histological analysis of a renal biopsy specimen showed proximal tubular abnormalities (Box). In addition, he had severely reduced bone mineral density, elevated bone turnover markers and vitamin D deficiency. The patient’s tenofovir therapy was ceased, he was started on an alternative antiretroviral regimen, and he was given phosphate, potassium, bicarbonate and calcium supplementation plus vitamin D and calcitriol therapy. Two months later, his serum creatinine level was 130 μmol/L, his eGFR was > 60 mL/min/1.73 m2, and his proteinuria, glycosuria and aminoaciduria had resolved. His leg pain and weakness resolved within another month. He has since been able to recommence full-time study. The persistent biochemical and renal abnormalities in this patient may have been a result of delayed recognition of Fanconi syndrome leading to prolonged illness. Risk factors for tenofovir-associated nephrotoxicity include a GFR of less than 90 mL/min/1.73 m2, use of nephrotoxic medications, comorbidities (eg, diabetes and hypertension) and use of some protease inhibitors. Patients on tenofovir should be screened at least 6-monthly for eGFR, serum phosphate levels, proteinuria and glycosuria.4 Three-monthly testing is also suggested in the initial year, due to the occurrence of tenofovir-associated nephrotoxicity without risk factors.5 Urinary protein to creatinine ratio is usually increased in tenofovir-associated nephrotoxicity, and tests for some urinary proteins may be useful in subtle cases of the condition.3 Testing for albuminuria (a marker of glomerular disease) and sole reliance on eGFR are insufficient for detecting tenofovir-associated tubular dysfunction.3 Due to potential renal toxicity, optimal outcomes for patients on tenofovir require careful monitoring of patients and close liaison between treating practitioners. Renal biopsy specimens showing proximal tubular abnormalities in a patient with tenofovir-associated Fanconi syndrome A: Prominent changes of acute tubular necrosis (haematoxylin and eosin stain; original magnification, × 4). B: Acute tubular necrosis with proximal tubular eosinophillic inclusions (arrows) representing giant mitochondria visible by light microscopy (haematoxylin and eosin stain; original magnification, × 10).

David M Gracey · Mangalee Fernando · John Ziegler · Christopher P White · Jeffrey J Post

To the Editor: Participation by patients in cancer clinical trials is low. Doctors’ reluctance to participate in clinical trials has been reported as a key barrier to recruitment.1 The Physician Orientation Profile (POP) examines doctors’ attitudes to and behaviour regarding randomised clinical trials.2 In the context of a 2010 cluster-randomised trial to assess the impact of a consumer-friendly cancer clinical trials website (http://www.australiancancertrials .gov.au), we asked medical oncologists to complete the POP and identify barriers they faced when recruiting patients to trials. The option of providing a comment on barriers identified was included. The sociodemographic characteristics of the 28 medical oncologists who participated in the trial and the barriers to recruitment reported are shown in the Box. Twenty-one doctors reported that they faced barriers when recruiting patients to clinical trials. The most common barriers identified included poor organisational infrastructure, insufficient time, slow and bureaucratic ethics approval processes, and lack of staff (medical oncologists and clinical trials coordinators). This was associated with the feeling that it is too hard to do trials. However, in contrast to studies reported during the 1990s in the United States and the United Kingdom,1,2 we found that doctors were strongly supportive of clinical trials. A high proportion gave answers consistent with the attitudes of “researchers” (practice guided by published data) rather than “clinicians” (practice guided by clinical experience). For example, if there was uncertainty about treatment, most saw this as an opportunity to do a randomised trial (26 of 28), and most believed that clinical trials were central to a medical oncologist’s practice (24 of 28). We acknowledge our small sample size and the likelihood of selection bias. However, the doctors in our study were experienced in recruiting patients to clinical trials and had firsthand knowledge of barriers to recruitment in the Australian medical system. Our findings suggest that, rather than negative attitudes of doctors, issues regarding organisational infrastructure, staffing, time and ethics approval processes are now significant barriers to recruitment of patients to cancer clinical trials. The participating doctors’ comments about the challenges of ethics and governance processes are consistent with recent publications which highlight that multisite studies are under threat because of onerous ethics review and regulatory requirements.3,4 These issues are also addressed in the first rec-ommendation of the Australian Government’s Clinical Trials Action Group report, which is “to improve the timeliness of ethics and research governance review”.5 Our results support the importance of this recommendation. Australian medical oncologists’ sociodemographic characteristics and barriers to recruiting patients to trials (n = 28), 2010 Number* Sociodemographic characteristics Mean age (years) 48 Men 20 Location New South Wales 17 Victoria 11 Practice type Mostly salaried 10 Mostly fee-for-service 9 About equal 9 Barriers to recruitment One or more barriers 21 Poor organisational infrastructure (eg, “Lack of support to employ clinical trials staff”) 11 Lack of time 9 Lack of access to clinical trials due to geographic isolation 8 Difficulty identifying eligible patients 4 Trials competing for the same patients 2 Lack of awareness about ongoing trials 2 Preference for a particular treatment arm 0 Other† 11 No barriers 7 * Data are numbers unless otherwise indicated. † Examples of comments provided for other barriers: “Hopeless, slow ethics in NSW — central ethics has not helped. Average time to get trials going exceeds average working life of trials coordinators!! It is TOO HARD to do trials. The logistics and lack of infrastructure is a major barrier” “Bureaucratic ethics and governance requirements” “Profound delays in ethics approval” “Lack of resources and man power to put more clinical trials in our treatment centre. Sometimes forgetting about ongoing trials if I am not the principal investigator and sometimes not aware of ongoing trials outside our centre” “Lack of additional medical oncologists” “Insufficient clinical trials coordinators — constant overload of staff means we have to keep halving study accrual”

Rachel F Dear · Alexandra L Barratt · Martin H N Tattersall

To the Editor: I am disappointed by Williams and colleagues’ blinkered view on “conflict of interest”.1 Their focus is solely on that of influence by profit-making medical supplies companies, often loosely referred to as “big pharma”. However, many careers are made and lost by government-influenced appointments and funding. The careers of some doctors in government-funded positions may hinge on whether they support the health department stance on a particular guideline. Rarely have I seen a future promotion, government research funding, committee appointment or professorial sinecure listed as a conflict of interest. This, I believe, is the real elephant in the room.

Peter J McLaren

To the Editor: We read with interest the article by Pinto and colleagues regarding colonisation of reusable tourniquets by multiresistant organisms (MROs).1 We highlight that surgical adhesive tape also has the potential to act as a significant fomite in health care settings. We collected partially used surgical tape rolls from several clinical areas of three hospitals in the Hunter New England Area Health Service. Using hands disinfected with alcohol gel, tape rolls from different locations in each area were placed into 21 clean collection bags (up to three tapes per bag). Tapes from each batch were placed in 21 sterile containers with 15 mL of brain–heart infusion broth and incubated overnight at 35°C in carbon dioxide. The broths were subcultured onto Columbia horse-blood agar (Oxoid Australia, Adelaide, SA), MacConkey agar (Oxoid) and differential selective media to detect vancomycin-resistant enterococci (VRE) (chromID VRE; bioMérieux, Marcy L’Étoile, France), methicillin-resistant Staphylococcus aureus (MRSA) (Brilliance MRSA; Oxoid) and multiresistant gram-negative bacteria (chromID ESBL; bioMérieux). A multiplex tandem polymerase chain reaction assay (MRSA4; AusDiagnostics, Sydney, NSW) to detect MRSA and methicillin-susceptible S. aureus (MSSA) was also performed on all broth cultures. Routine species level identification was performed (VITEK MS; bioMérieux). Susceptibility was determined in accordance with Clinical and Laboratory Standards Institute criteria.2 In 11 of the 21 tape batches, MRSA and/or VRE were identified. Of these, four were positive for MRSA and 10 for VRE, with three positive for both. MSSA was identified in two, both in association with VRE. All batches showed evidence of contamination with other bacteria such as Bacillus cereus, coagulase-negative staphylococci, non-multiresistant Enterobacteriaceae, Pseudomonas spp, Acinetobacter spp and other enterococci. Our results indicate that surgical adhesive tapes are frequently contaminated with MROs. Interpretation of these results is limited by the small number of tapes and clinical areas sampled, and the difficulty of proving a relationship to clinical infection. However, items such as intravenous cannulae, surgical drains and wound dressings are frequently fixed using surgical adhesive tape. This may lead to colonisation and subsequent infection. Furthermore, tape rolls are often left lying on contaminated surfaces, are handled by multiple individuals and cannot be disinfected. Surgical adhesive tape is a potential reservoir of pathogenic bacteria3 and fungi4 and was implicated in a prolonged S. aureus outbreak in a neonatal unit.5 The role of surgical tape as a potential fomite was reported in 19746 but has not been widely acknowledged since. Removing the outer layer of the tape roll is unlikely to reduce contamination, given visible contamination of the side of many rolls (Figure).3 Short rolls of surgical adhesive tape should be supplied in sealed packets and used for individual patients, only after hand disinfection, and discarded after use.

Patrick N A Harris · Chris Ashhurst-Smith · Sandy J Berenger · Alison Shoobert · John K Ferguson

To the Editor: Antimicrobial resistance has been identified as a major concern in Australia, particularly as few new antimicrobial agents are being developed.1 Studies suggest that up to half of antimicrobial agents prescribed in hospitals are inappropriate.2-4 Antimicrobial stewardship interventions, including dissemination of clinical guidelines and restrictions on antimicrobial formularies, may not be fully able to account for the complex indications for antimicrobial use in hospitalised patients. We instituted a rapid clinical audit and feedback system of patients on one of 14 restricted antimicrobial agents as a component of antimicrobial stewardship activities in 2011 at the Alfred Hospital in Melbourne. Multidisciplinary antimicrobial stewardship ward rounds involving a senior clinical pharmacist, an infectious diseases (ID) registrar and an ID physician were performed on weekdays. Patients in units (respiratory, haematology/bone marrow transplantation, burns and intensive care) who had existing liaison ID services were excluded from our analysis. Patients included in the analysis were prescribed a restricted antimicrobial, either for an indication outside hospital policies, or where approval had not been obtained through a web-based antimicrobial approval system. Between January and April 2011, 473 patients were identified as requiring review by the antimicrobial stewardship team. In total, 236 recommendations (Box) were made for 158 patients across all 18 units (73% surgical, 27% medical). For other patients, antimicrobial use was deemed clinically justified or the antimicrobial agent had been ceased at the time of review. Recommended changes to therapy involved ceftriaxone (n = 70), piperacillin/tazobactam (n = 23), ciprofloxacin (n = 22) and vancomycin (n = 18). A formal referral to the ID consultation service was made for 11 of the 236 patients (5%). Recommendations were followed in 78% (184/236) of cases; acceptance of recommendations was higher when review involved the ID physician (146/176, 83%) than when it did not (38/60, 63%; P = 0.002). Rapid clinical review by a multidisciplinary antimicrobial stewardship team was able to assess large numbers of patients requiring restricted antimicrobial agents. Postprescribing evaluation has been reported mainly in North American studies, but has not been reported in Australian hospitals.5 In most patients, agreement was reached with the treating clinicians to cease or reduce the use of antimicrobial agents, suggesting that their ongoing use was not clinically justified. In addition, regular ward rounds by the team supported compliance with the antimicrobial approval system, provided education to junior medical staff and identified antimicrobial use protocols that had no basis in evidence. Proportion of the antimicrobial stewardship team’s recommendations accepted Recommendation Accepted Stop antimicrobial agent 72% (56/78) Change drug dose 75% (33/44) De-escalate antimicrobial cover 83% (25/30) Change to oral antimicrobial agents 90% (26/29) Change drug to alternative 88% (21/24) Formal infectious diseases consult 64% (7/11) Initiate antimicrobial 73% (8/11) Additional management 100% (4/4) Additional diagnostic procedures 67% (2/3) Therapeutic drug monitoring 100% (2/2) Total 78% (184/236)

Kelly A Cairns · Adam W J Jenney · Sushena Krishnaswamy · Michael J Dooley · Orla Morrissey · Sharon R Lewin · Allen C Cheng

To the Editor: The median age of Australian patients at first diagnosis of cancer is 67.8 years.1 In advanced, incurable cancer, goals of treatment include symptom control for all patients and prolongation of survival by weeks to months in a subgroup. In older people, treatment decisions can be complicated by comorbidities, polypharmacy, frailty and cognitive impairment. Few studies have investigated older patients’ information needs and preferences for involvement in decisions about their care.2,3 We performed an exploratory study to investigate whether the health status of older cancer patients predicted their information needs, decision preferences and their oncologists’ treatment recommendations. Concordance between patients’ stated preferences and the perceptions of their oncologists was also measured. Fifty outpatients with advanced lung (n = 30) or bowel (n = 20) cancer, with a mean age of 66.9 years (range, 51–91 years) participated. Fourteen patients (28%) were older than 70 years and 80% were diagnosed with advanced cancer within the previous 4 months. Patients’ health status was measured using the Vulnerable Elders Survey (VES) 13, a validated questionnaire used to identify older persons at risk of health decline (indicated by scores of ≥ 3).4 Role preferences were elicited using the Control Preferences Scale.5 Thirteen patients (26%) had VES 13 scores of ≥ 3. Of these, five (38%) were over 70 years. Twenty-six of 49 patients (53%) wanted a passive role in decision making, and 29 of 50 patients (58%) wanted prognostic information. Age and VES 13 scores did not predict patients’ role preferences or desire for prognostic information. Oncologists were less likely to recommend chemotherapy for patients over 70 years (25% v 75%, P = 0.04) or for those who had VES 13 scores of 3 or above (20% v 80%, P = 0.02). Concordance between patients’ participation preferences and oncologist perceptions was 54%. Until there is more evidence from larger studies of patient preferences, oncologists should ask patients their preferences about decision making and prognostic information. Patients with advanced cancer, by characteristic and preference Characteristic Prefer non-passive decision control* Prefer prognostic information Total patients (n = 50) 23 29 Age 50–60 years 6 7 Age 61–70 years 11 14 Age 71–80 years 5 5 Age > 80 years 1 3 Male 10 18 Female 13 11 Born in Australia 15 14 Born outside Australia 8 15 Bowel cancer 13 19 Lung cancer 10 10 0 comorbidities† 3 5 1 comorbidity† 3 5 2 comorbidities† 4 7 ≥ 3 comorbidities† 12 12 0 concomitant medications‡ 1 4 1 concomitant medication‡ 2 3 2 concomitant medications‡ 7 5 ≥ 3 concomitant medications‡ 13 15 Lives alone 8 9 Lives with someone 15 20 Lives in aged care facility 0 0 ECOG PS = 0–1 20 24 ECOG PS = 2–3 2 4 Married 9 13 Not married 14 16 Primary education§ 3 5 Secondary education§ 14 14 Tertiary education§ 5 10 VES 13 score = 0–2¶ 17 19 VES 13 score = > 3¶ 6 10 ECOG PS = Eastern Cooperative Oncology Group performance status; higher score = poorer status. VES = Vulnerable Elders Survey. * Total in passive and non-passive categories was 49 (one patient gave no preference). † Missing data for one patient. ‡ Missing data for three patients. § Missing data for two patients. ¶ VES 13 scores range from 0–10; scores > 3 indicate vulnerability to health decline.

Lakshmi P Venkateswaran · Phyllis N Butow · Jesse Jansen · Nicholas R C Wilcken · Mark K Wong · Rina Hui · George Szonyi · Val J Gebski · Vasi Naganathan · Lisa G Horvath · Martin H N Tattersall

To the Editor: Multidisciplinary meetings (MDMs) are recognised as crucial to best practice in oncology, and governments have designated MDMs as key priorities in cancer care.1,2 Improvement in overall survival has been promoted as a potential benefit of multidisciplinary care, with little supporting evidence. However, consensus MDM decisions are worthless unless action is subsequently implemented. This retrospective audit aimed to assess whether MDM recommendations were implemented, as an indirect measure of the MDM process on patient outcomes. MDM records for patients discussed at the Austin Health (Melbourne) Uro-Oncology, Upper GI (gastrointestinal) and Colorectal Cancer MDMs between February and April 2010 were reviewed, and consensus recommendations were compared with treatment plans documented in the medical record. Reasons for change in management were classified as (1) new clinical information unavailable to MDM; (2) patient’s choice; (3) comorbidities or patient performance status; or (4) not otherwise specified. The Box summarises the results. Overall concordance was 76% (152/201 records). In 41 records (20%) in which an MDM discussion was documented, data were not available due to missing or incomplete MDM documentation in the medical record. Excluding records where data were unavailable, concordance was 95% (152/160 records), with discordance due to new clinical information (5), comorbidities or performance status (2) and patient choice (1). These results highlight a few issues. Documentation of MDM discussion and consensus decision is required for the MDM recommendations to be delivered to patients and communicated to other clinicians. This documentation may have been missed due to differences in recording systems (paper versus electronic; designated person recording) or MDM structure (pre-specified agenda versus ad-hoc discussion), which need to be addressed. The high concordance rate (where documentation was available) suggests that MDM management recommendations are being delivered and acted upon, and so effectively promote high-quality, evidence-based care. This assumes that the MDM always uses evidence-based medicine and includes all relevant members of the treating team. This aspect was not analysed as part of this audit. However, in support of this assumption, we found that neoadjuvant chemotherapy for stage T3 or greater muscle-invasive bladder cancer was not given before institution of MDMs in 2007 (0/19 potential patients), but is now regularly discussed at the Uro-Oncology MDM and is administered where appropriate (7/20 patients between 2007 and 2010). This suggests a positive effect of this MDM on access to a therapy known to improve survival. Our findings suggest that MDM recommendations are usually acted upon and improve patients’ access to appropriate treatment.3 Results of an audit of records of Uro-Oncology, Upper GI (gastrointestinal) and Colorectal Cancer multidisciplinary meetings, Austin Health, February – April 2010 Total no. of records Data not available, no. (%) Overall concordance, no. (%) Concordance when data available, no. (%) Discordance, no. (%) Uro-Oncology 118 32 (27%) 85 (72%) 85 (99%) 1 (1%) Upper GI 40 3 (8%) 34 (85%) 34 (92%) 3 (8%) Colorectal 43 6 (14%) 33 (77%) 33 (89%) 4 (9%) Total 201 41 (20%) 152 (76%) 152 (95%) 8 (4%)

George H Au-Yeung · Ahmad Aly · Andrew Bui · Carmel M Vermeltfoort · Ian D Davis