Medical practices

To the Editor: When I looked at the cover of the 5 April issue of the MJA, I feared finding another article focused on discrediting the prostate-specific antigen (PSA) test. Instead, I congratulate the authors, and the Journal, for presenting one of the rare balanced articles on this topic.1 Denham and colleagues called for an end to taking sides in the debate over PSA testing, and focused instead on helpful guidance. The problem is not whether PSA helps us find prostate cancer, but that we lack clinical tools for deciding which patients would benefit from aggressive treatment. However, the authors point out that there are two important tools that can help with this decision: low free to total PSA ratios, and rapid PSA doubling time (< 3 years).1 The PSA test is now one of the most sensitive, precise and highly standardised immunoassays in the clinical laboratory. The difficulty does not lie with the measurement but with its application. The Royal College of Pathologists of Australasia, together with the Urological Society of Australia and New Zealand, recently produced a monograph that discussed the appropriate use of the PSA test.2 It emphasised using age-related cut-offs for PSA levels, the free to total PSA ratio, and the calculation of PSA doubling time as modern tools to achieve optimal benefit from the test. The Australian Medicare Benefits Schedule (MBS) was changed in May 2009 (following a suggestion from the Urological Society of Australia and New Zealand) to improve utilisation of free to total PSA ratios. The Box indicates the per capita request rates of PSA testing (MBS item number 66655) and free to total PSA ratios (MBS item number 66659) from May 2009 to February 2010. Consistent with Denham et al’s observation that there are regional differences in the attitudes to prostate cancer,1 there is a twofold variation in PSA requesting and a sevenfold difference in free to total PSA ratio requesting across the Australian states. Furthermore, the relationship between the two tests is, if anything, inverse, suggesting that increased use of PSA testing is less commonly followed up by modern tools such as free to total PSA ratio. As a chemical pathologist, the appropriate clinical use of the PSA test has been a career-long concern of mine.3 Even though the discoverer of PSA has labelled the test a public health disaster,4 recent “case–controlled” studies using PSA in an outdated approach (without free to total PSA ratios or doubling times) have shown a marginal benefit for screening.5,6 The indiscriminate use of PSA testing can be helpful to some but disastrous for others. Modern PSA tools may significantly improve management beyond these marginal effects. As always, the value of medical investigations lies in how intelligently we use them. Average per capita request rates of PSA testing* and free to total PSA ratio,† May 2009 – February 2010 PSA = prostate-specific antigen. ACT = Australian Capital Territory. NSW = New South Wales. NT = Northern Territory. Qld = Queensland. SA = South Australia. Tas = Tasmania. Vic = Victoria. WA = Western Australia. * Medicare Benefits Schedule (MBS) item number 66655. † MBS item number 66659.

Kenneth A Sikaris

A 66-year-old woman on peritoneal dialysis for end-stage renal disease secondary to diabetic nephropathy was admitted on Christmas Day with suspected osteomyelitis of her left third toe. During admission, she complained of constipation and mild abdominal pain. There were no focal abdominal findings on examination. Of note, she was prescribed 750 mg three times daily of the rare metal lanthanum carbonate hydrate for hyperphosphataemia of renal failure. An abdominal x-ray was taken after the second dose of the day (Figure). Lanthanum has been shown to be radio-opaque on x-ray1,2 and computed tomography,3 and this is briefly mentioned in the full product information. The radiology report in this case suggested alternative diagnoses of residual contrast from a barium study, sclerosing peritonitis, tuberculosis or lead ingestion, none of which were consistent with the clinical history. The use of lanthanum as a phosphate binder is likely to increase since it was listed on the Pharmaceutical Benefits Schedule in 2009. Awareness of its radio-opaque features will prevent unnecessary investigations.

Yohan Chacko · Carolyn J Clark

To the Editor: The recent clinical update by Chakera and colleagues highlights the problems and adverse patient outcomes that occur when current and prior diagnostic images are not accessible during the clinical care process.1 While the article describes a locally crafted, tactical, information technology (IT) solution, it fails to mention that much work has been done internationally to create a standards-based, scalable architecture for image and document exchange. This work has been done by Integrating the Healthcare Enterprise (IHE) (http://www.ihe.net), a global collaboration between health care equipment suppliers, IT experts and clinicians. The aim of the collaboration is “to improve the way computer systems in healthcare share information”. The profile for cross-enterprise document and image sharing is known as XDS-I. XDS-I defines how to use established health care and IT standards (eg, the Digital Imaging and Communications in Medicine [DICOM] and Health Level 7 [HL7] standards2,3) to facilitate secure exchange of health care information, including images, between health care institutions. Information exchange is independent of the hardware and software in place at the participating institutions, and system integration using XDS-I supports user needs, including security and privacy, while streamlining workflow. Using a single technical approach, implemented at a regional or state level, diagnostic images can be exchanged, along with documents such as radiology and laboratory reports, discharge summaries, and even general practitioner care plans. Providers can, with patient permission at the time of care, access such documents via secure internet connections. The solution developed by Chakera and colleagues covers Western Australian public hospitals and parts of the private sector. XDS-I is a platform that also allows image sharing between the public and private sectors, regardless of the picture archiving and communication system adopted by participating practices or hospitals. Many of the operational problems identified in the article by Chakera and colleagues (consent, staff time costs and manual processes) have been addressed in the IHE XDS-I profile. While projects such as the pilot program by Chakera and colleagues are useful learning exercises, locally crafted single-vendor solutions (even those using industry standards) are rarely scalable to broader usage. We strongly commend the IHE XDS-I model to everyone considering image exchange systems in Australia.

Nicholas J Ferris · Philip J Dubois · Christopher Lindop · Vincent B McCauley · Peter A MacIsaac

To the Editor: Alarm about the dangers of computed tomography (CT) scans1,2 is unjustified. The only hard facts about bio-harm from ionising radiation come from the 1945 atomic bomb explosions, which emitted very large amounts of radiation. Bio-harm from low-dose medical radiation has never been confirmed; the claim is based on backward extrapolation of data on radiation doses from the Japanese atomic bombs, which were orders of magnitude greater than doses in diagnostic radiation. The resultant linear no-threshold theory, which postulates that there is no safe radiation dose, remains unproven. Radiation protection authorities use this model because it is expedient, if unverified and overly conservative. Those who treat it as dogma forget that it remains a theory, and any derived calculations are subject to large uncertainties. Radiation scientists question its validity,3 and many regard the estimated risks as grossly exaggerated or negligible.4 The Health Physics Society has stated that the risks to health from radiation doses below 100 mSv are either too small to be observed or non-existent.5 The theory is also challenged by evidence that low-dose radiation is actually beneficial and protects against the effects of large-dose radiation by inducing DNA repair enzymes. A study of 407 000 nuclear shipyard workers and another of 7800 Russians exposed to low-level radiation from the 1957 Mayak nuclear facility accident showed that the exposed groups developed significantly less cancer than their unexposed controls.4 The lifespan of British radiologists over the past century has exceeded that of any other control group.6 Figures quoted in the media for cancer attributable to medical radiation are theoretical calculations and have never actually been observed. They are as “real” as estimated cancer rates due to mobile phones and power lines. Newspaper claims such as “More than 400 new cases of cancer a year in Australia are attributable to diagnostic radiology”2 are alarmist and misleading — they disguise the fact that their figures derive from an unproven theory, not from observations. Ironically, concern about the dangers of CT is rising even as the actual radiation doses involved are falling. A 2010 CT scanner emits 1/20th the radiation of its 5-year-old predecessor. CT coronary angiography can be accomplished today with a dose of less than 1 mSv — equivalent to six chest x-rays or 6 months of background radiation. Patients for whom a CT scan is medically indicated should not be denied one of modern medicine’s greatest benefits because of unfounded fears. The risks of delayed or missed diagnosis or wrong treatment far outweigh the theoretical risk of harm from a CT scan.

Carl M Blecher

A 61-year-old woman presented for management of a large, toxic multinodular goitre. A decision about therapeutic modality (radioiodine ablation or total thyroidectomy) was facilitated by an incidental finding, on computed tomography, of a large, anterior mediastinal thymoma (Figure, A), confirmed by core biopsy. The patient had no symptoms of tumour compression or paraneoplastic phenomena such as myasthenia gravis. She underwent a total thyroidectomy and resection of the thymoma by median sternotomy. Histopathological examination revealed a completely encapsulated and resected thymoma (stage 1, World Health Organization type B2 [mixed epithelial and lymphoid cells]) measuring 140 × 80 × 45 mm (Figure, B), and a benign multinodular goitre. A: Sagittal view of a computed tomography scan of the neck and chest showing a large multinodular goitre (black arrow) and a large incidental anterior mediastinal thymoma (white arrows). B: Resected thymoma.

Jimmy Z Shen · Jui T Ho

Patients need to make an informed choice about their pathology referrals In February 2010, despite representations from the Royal College of Pathologists of Australasia (RCPA) and the Royal Australian College of General Practitioners (conveyed via letters, meetings and discussions), the federal government introduced legislation into Parliament to require all pathology request forms to be marked with the advice to patients that they may be taken to any pathology provider.1 Pathology services underpin modern health care, playing a role in 70% of diagnoses and medical decisions.2 The key concern of health professionals is that the “non directed” pathology referral will put patient safety at risk and undermine the quality of information that pathologists provide to patient care. The proposed legislation arose from an interdepartmental review of pathology funding led by the Australian Department of Finance and Deregulation and is touted as creating patient choice.3 However, from the health professional’s perspective, the initiative may seem, at best, disingenuous. Patients have always had the right to take part in choosing their pathology provider — as they do for other medical specialist referrals. Shared decision making between doctor and patient is the strength of the medical specialist referral system, and is of particular importance in making choices about pathology (the “invisible” medical specialty). Amending the request form with a clause advising patients that it may be taken to any pathology provider encourages patients to make the decision on their own, after they have left their doctor’s surgery — thus making this a “patient choice” initiative that threatens fully informed choice. Patients may infer from this government directive that it does not matter which pathology provider they use — that they are all the same. In fact, this is not the case. Although all pathology providers are required to meet a national standard of accreditation, they differ in the range of expertise of their pathologists and laboratory teams, their test catalogue and technologies, the content of reports, their second-opinion networks, their access to pathologists for advice, their turnaround times and notification of urgent results, and their after-hours services. Little of this variability may be apparent to patients, who may instead make their “choice” on the convenience of sample collection and price alone, without due regard to the nature of the pathology consultation their doctor sought or whether the important information will be effectively communicated to their doctor. Patients may choose to shuttle between various pathology providers without understanding the effect this journey may have on the type and usefulness of information provided by pathology testing. For many diseases, a unique diagnostic opportunity arises from testing being carried out in one laboratory over the course of a patient’s acute illness. Pathologists can integrate the findings of a range of tests over time to make a diagnosis and can identify disease progression, remission and recurrence earlier, and with more certainty, from a complete and continuous pathology record. Patients with chronic diseases may understand the importance of serial pathology testing, but may not realise that the tests performed and their reference ranges may vary between laboratories, to the extent that the use of multiple pathology practices could compromise their doctor’s efforts to monitor results and could even affect their treatment. Even laboratories that use the same reference ranges may use their own cumulative or graphical reports of test results to highlight changes in the control of common diseases such as diabetes and cancer and in warfarin therapy. Thus, significant changes in a patient’s disease status may not be recognised if they are presented by a new pathology provider independently of previous data gathered on the patient. Lastly, patients may not understand the effect that their independent choices about pathology providers may have on the communication and traceability of their results. The information required for critical decisions may be delayed or lost because the pathology practice cannot deliver reports to an unknown doctor and the doctor cannot pursue them because he or she does not know which practice the patient chose to attend. A large medical indemnity organisation has indicated that it will need to provide risk management advice to its members should this measure be implemented (David Nathan, Chief Executive Officer, Avant Mutual Group Limited, in a letter dated 3 November 2009 referring to an RCPA letter sent to medical indemnity insurers on 17 September 2009 to acquaint them with this measure). Is this good health policy? Can it be good if it cuts across pre-existing good policy on quality, safety and connectivity (ie, delivery of medical information by information technology systems). The federal government seems intent on proceeding with this legislation, despite the establishment of a Senate inquiry into the risks it poses to patient safety.4 Why is this? Why is the government seeking to interfere in and weaken the doctor’s role in advising patients about their health care? If this is about patient choice, then surely patients would universally choose to be safe? So, if it is not about patient choice, what is it about? By portraying pathology services to the Australian public as being all the same, with no distinction made between the levels of service or expertise offered by different providers, the Department of Finance and Deregulation would be sending a message that pathology is a commodity, to be bought at the lowest price. This premise could be used to justify fee cuts and tendering, both of which are on the federal government’s radar.5 All Australians (including patients and doctors) need to be aware of the risk to patient care once the case has been made that pathology is a commodity rather than a medical service. This risk is not merely theoretical. In Ireland, after a recent government-led tender, all Pap smears from Irish women are now to be reported by a pathology service in the United States — effectively putting an end to training (and the destruction of competency) of Irish pathologists in this area of pathology.6 In New Zealand over the past decade, tendering of pathology in each of the 21 district health boards has disrupted not only patient care but also the pathology workforce.7 There has already been significant government disinvestment in Australian pathology over the past 5 years, with the proportion of the Medicare dollar spent on pathology falling significantly despite a dramatic rise in test numbers over that period (Ed Wilson, Principal, EW Consulting P/L, personal communication). A further government review of pathology funding is underway.5 It is aimed at saving more money and will bring us closer to the line beyond which funding is no longer sufficient to allow pathology practices to maintain the standard expected by Australian doctors and their patients. In recent years, this line has probably already been crossed in Canada, where chronic underfunding has been identified as a major cause of the widespread failure of diagnosis of breast cancer, with resultant government inquiries being conducted.8 The proposed changes to legislation cannot be justified on the spurious grounds that pathology is a commodity and that patients are being offered “choice”, when in fact the choice already existed. If the federal government’s agenda is to reduce funding for pathology services, it needs to take responsibility for its decision and the consequences of that decision for patient care.

Beverley J Rowbotham MD, FRACP, FRCPA

Objective: To evaluate the changes in the understanding of the manner and cause of death occurring during the course of coronial investigations.Design: Retrospective analysis of deaths reported to coroners in Australia between 1 July 2000 and 31 December 2007, using the National Coroners Information System.Main outcome measures: (i) Manner of death (natural, external, unknown); (ii) intent classification (eg, unintentional injury, suicide, assault) among deaths with external causes; and, (iii) changes in the manner of death and intent classification between the presumption made at case notification and the coroner’s final determination.Results: The coronial investigation changed the presumption about manner of death or intent classification in 5.2% (6222/120 452) of cases in which a presumption was made. Among deaths with a change in attribution from natural causes to external causes, unintentional falls (442/1891) and pharmaceutical poisoning (427/1891) each accounted for 23%. Among deaths with attribution changing from external causes to natural causes, the leading medical causes of death were cardiovascular compromise (551/842; 65%) and infection (124/842; 15%). Of deaths understood correctly at notification to be due to external causes, but the wrong external cause, 34% (206/600) were ultimately judged to be unintentional injuries, and 22% (133/600) were judged to be suicides.Conclusions: Coronial investigations transform basic understanding of cause of death in only a small minority of cases. However, the benefits to families and society of accurate cause-of-death determinations in these difficult cases may be considerable.

David M Studdert LLB, ScD, MPH · Stephen M Cordner MB BS, BMedSc, DipCrim

To the Editor: The risks of computed tomography (CT) are now well understood by radiologists and have been widely reported.1−3 Overall, the risk of fatal malignancy from a single CT scan (body, not including head) in children and young adults is about 1 in 1000 (varying from around 1 in 500 to 1 in 1500), and the high risk persists into the third decade.1,2 The risk is higher in children and young adults because there is time for malignancy to manifest (usually developing decades later), and their cells are dividing more rapidly and hence more susceptible. However, surveys of both patients and referring doctors show they have limited knowledge of the radiation risks from CT.4 Hence, most patients presenting for CT scans are not informed or aware of the risk. The High Court of Australia has determined that medical staff must inform patients of potential risks that the patient might regard as important.5 Patients, and their parents, may well consider a 1 in 1000 chance of fatal malignancy important. Most hospitals and clinics routinely recommend obtaining written, informed consent before administration of general anaesthesia or intravenous contrast agents. Some also routinely provide written information to parents or patients of the risks associated with general anaesthesia and anaphylaxis following administration of intravenous contrast agents. The risks of fatal malignancy developing later in life in children and young adults after a single CT scan are 1/500 for children aged less than 1 year, 1/1250 at 10 years, and 1/1600 at 20 years.1 This is 50–200 times greater than the risk of fatality following general anaesthesia (1/56 000)6 or administration of intravenous contrast agents (1/170 000).7 If informed consent is regularly sought before administration of general anaesthesia and intravenous contrast agents, then it is equally appropriate and consistent to seek informed consent before CT scans in children and young adults. Anything less may not be medicolegally sustainable. While patients rightly expect that referring doctors are able to balance the risks and benefits of any examination, they also rightly expect (and the High Court supports them) that any known risk will be revealed and discussed. Explicit and comparative information is best provided personally and in understandable written format by the referrer.8

John F de Campo · Margaret P de Campo

Comparative effectiveness research may stimulate heated debate, but ultimately, those who question its findings need to provide high-quality data to support their arguments One consequence of the continuing rise in the cost of health care has been the emergence of comparative effectiveness research.1 This variant of evidence-based medicine is defined as: . . . the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care.1 Furthermore, the purpose of comparative effectiveness research is: . . . to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.1 When confronted with health care consuming an ever-increasing percentage of the gross domestic product, politicians and policymakers have enthusiastically embraced comparative effectiveness research,2 and Prime Minister Rudd is no exception. In a recent speech, Mr Rudd proclaimed that medical research needed to play a greater role in reducing burgeoning health budgets. “Patients need treatments, technologies and procedures for which there is evidence from research that these are safe and effective.”3 He cited a recent article in the New England Journal of Medicine (NEJM), in which research by an Australian team “found a commonly available treatment for fractures of the bones of the spinal cord was in fact no better than doing nothing at all.”3 He was referring to the treatment of osteoporotic vertebral fractures with vertebroplasty — that is, the percutaneous injection of medical cement into the fractured vertebral body. Such procedures are performed in some 100 000 patients per year in the United States4 and about 700 patients per year in Australia.5 Late last year, this area of practice received a seismic shock when the NEJM simultaneously published two randomised controlled trials (RCTs) — one conducted in Australia6 and one in the US, the United Kingdom and Australia.7 These trials were conducted independently of each other, and both showed that the outcomes of vertebroplasty in patients with osteoporotic vertebral fractures were no different than for a placebo procedure. It was doubtlessly anticipated that publication of these two RCTs would inflame debate, arousing passionate defence of vertebroplasty.4 This is to be expected whenever evidence-based medicine clashes with the collective wisdom of clinical experience. For more than a decade, it had been argued that vertebroplasty was so successful that RCTs were unnecessary or even unethical!4 Not surprisingly, the two RCTs turned the practice of vertebroplasty on its head. In view of the seminal importance of these studies and seeking to inform the broad readership of the Journal, I duly sought an editorial from the lead authors of the NEJM studies, Professor Rachelle Buchbinder from the Monash Department of Clinical Epidemiology at Cabrini Hospital in Melbourne and Professor David Kallmes from Mayo Clinic in Rochester in the US. Then strange things began to happen. Just before the editorial was published, I received an email critical of its content. Then, subsequent to its appearance in the 2 November 2009 issue of the Journal, further emails arrived advising, among other things, that the editorial be retracted. Medical science has always thrived on debate in an open forum, wherein discussion and interpretation of the evidence is to be encouraged. Yet, I was the recipient of closed communications pointing out the weaknesses of the RCTs, as well as suggesting that the reputations of the NEJM and the Medical Journal of Australia had been diminished by the original publication of the RCTs and our subsequent editorial. More sinister, perhaps, is the fact that Professor Buchbinder was subjected to a far more vitriolic campaign, necessitating the threat of legal action (Rachelle Buchbinder, personal communication). In this issue of the Journal, we publish the views of Clark and colleagues, a group of Australian vertebroplasty experts,8 and the rejoinder by Buchbinder and colleagues.9 Clark et al point, among other things, to problems with patient selection and recruitment as a reason for the negative findings of the RCTs, while Buchbinder et al robustly defend the findings and their subsequent interpretation. It is up to the readers of the Journal to decide for themselves whether the two trials and the editorial that sought to interpret them represent the best available evidence on the effectiveness of vertebroplasty. Where do we go from here? It is easy to be critical of study methods, findings and interpretations, but I strongly believe that, when considering important clinical issues, criticisms must not be ad hominen but be supported by new data. It may well be argued that vertebroplasty should no longer be performed except in the context of a study aimed at resolving unresolved questions.4 At the very least, vertebroplasty practitioners should now relate the outcomes of the NEJM trials in their discussions with patients before proceeding to gaining their informed consent.10

Martin B Van Der Weyden MD, FRACP, FRCPA

We use vertebroplasty for patients with the most severe pain caused by osteoporotic vertebral fractures less than 6 weeks old, and have observed dramatic pain relief in this acute setting. A recent editorial in the Journal, written by the authors of two recent vertebroplasty trials, suggested that vertebroplasty is not an effective therapy for acute osteoporotic vertebral fractures. The trials described in the editorial sampled a very different patient cohort to the one that we treat with vertebroplasty. Our clinical experience and most of the published literature relating to the benefits of vertebroplasty are in striking contrast to the opinions presented in that editorial.

William A Clark MB BS, FRANZCR · Terrence H Diamond MB BS, MB BCh, FRACP · H Patrick McNeil MB BS, FRACP, PhD · Peter N Gonski MB BS, BMedSci, FRACP · Glen P Schlaphoff MB Bch, FCRad(SA), FRANZCR · John C Rouse MB ChB, FRANZCR

Our recent editorial in the Journal presents an accurate summary of our two randomised trials of vertebroplasty, which found no benefit of vertebroplasty over placebo. Participants in both trials are representative of patients seen in clinical practice and who would qualify for government-subsidised funding of vertebroplasty in Australia. Clinical experience and previous published literature are likely to have overestimated the treatment benefit of vertebroplasty for many reasons. This is why randomised placebo-controlled trials are required to determine the efficacy of treatment interventions, particularly when the condition being treated is self-limiting and the primary end point is improvement of symptoms. Based on the best evidence currently available, the routine use of vertebroplasty outside of the research setting for painful osteoporotic vertebral fractures appears unjustified.

Rachelle Buchbinder MB BS(Hons), PhD, FRACP · Richard H Osborne BSc, PhD · David Kallmes MD

Australian federal and state governments were advised several years ago that an influenza pandemic would overwhelm Australian public reference laboratories. It was proposed at the time that currently underused capacity in the private sector be used to enhance pandemic responses. The current outbreak of pandemic influenza has confirmed the predictions of advisors from the private sector. Future official pandemic plans should be adjusted to take into account these observations.

Miles H Beaman FRACP, FRCPA, FACTM · Michael J Leung MB BS, FRCPA

Objective: To determine the relative radio-opacity on plain x-ray of bones of fish species commonly consumed in South East Queensland.Design: A cadaveric sheep model was used to mimic the soft tissues of a human neck. Bones of 10 fish species were placed in the paratracheal tissues and adjacent to the larynx. X-rays were taken and the images (including four control images with no bones) were incorporated into a Microsoft PowerPoint presentation to be interpreted by emergency specialists and registrars. Observers were blinded to which specimens contained fishbones and which did not.Main outcome measures: Sensitivity and specificity of plain x-rays for detecting impacted fishbones.Results: Significant interobserver variability was identified. Despite this, the overall specificity of plain x-rays was 90%. The sensitivity of the technique was 79% overall, but varied significantly between fish species.Conclusion: Lateral soft tissue neck x-ray is an appropriate screening tool in cases of a suspected impacted fishbone. If a fishbone is identified on x-ray, the patient should be referred for endoscopy without further imaging. X-ray may be of limited value in cases of Dory or Spanish mackerel bone ingestion. In such cases, a computed tomography scan should be the first-line investigation.

William R A Davies MB BS · Patricia J Bate PhD, MAppSci, BAppSc(Phty)

The delay in transfer of imaging studies when a patient moves between hospitals and between public and private systems has been a barrier to expedient and safe patient management. There is also suboptimal reporting when patients have serial imaging undertaken partly in the private sector and partly in the public sector, because of inability to access previous imaging for comparison. Availability of a DICOM (Digital Imaging and Communications in Medicine) server enables sharing of health information, including imaging data, across various sites and jurisdictions. In Perth, Western Australia, we have successfully introduced electronic image transfer between five public teaching hospitals and three large private practices with different picture archiving and communication systems.

Turab Chakera MB ChB, FRCP, FRANZCR · Yusuf Nagree FACEM · Swithin Song FRANZCR · Philip Jones DipAppSc

Two randomised placebo-controlled trials show the importance of establishing the efficacy of procedures before adopting them into clinical practice Vertebral fractures are a common manifestation of osteoporosis, and up to half such fractures result in severe pain and disability. Although most heal within weeks or a few months, some people experience persisting discomfort. Best supportive care includes bed rest, analgesia and physical therapy, and some patients require hospitalisation. Vertebroplasty, the percutaneous injection of polymethylmethacrylate (PMMA) into the affected vertebral body, has been widely accepted to be a safe and effective treatment for vertebral fractures on the basis of observational and quasi-experimental studies.1 Despite a lack of evidence from randomised controlled trials on which to base reimbursement decisions, some countries, including Australia, have recommended public funding of the procedure.2,3 Since being listed on the Medicare Benefits Schedule in November 2005, about 600 to 700 vertebroplasties have been performed in Australia annually (not including those performed in public hospitals),4 and at least 40 000 are performed in the United States annually.5 The results of the first two randomised placebo-controlled trials investigating this procedure have now been published in the New England Journal of Medicine.6,7 In the first study, performed in Australia, 78 participants with one or two acute osteoporotic vertebral fractures were randomly assigned to undergo either vertebroplasty or a placebo procedure (Box 1).6 To simulate the real procedure, patients in the placebo group underwent gentle tapping of a stylet resting on the affected vertebral body, and PMMA was prepared so that its smell permeated the room. All participants and research personnel other than those performing the procedure were blinded to treatment allocation. Vertebroplasty did not result in a significant advantage over placebo in any measured outcome at any timepoint, and pain reduced in both the treatment and placebo groups over time (Box 1). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven new vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6 months of follow-up, and one of these patients in the vertebroplasty group also developed osteomyelitis. In the second study, which was based in the US, but also included sites in the United Kingdom and Australia, 131 patients with between one and three painful osteoporotic vertebral fractures were randomly assigned to undergo vertebroplasty or a sham procedure (Box 2).7 The control group underwent local infiltration with local anaesthetic, but no stylet was inserted, and PMMA was also prepared so that the odour would permeate the room. Patients in both groups were allowed to cross over to the other procedure at 1 month or later if they wished because adequate pain relief had not been achieved. As in the Australian study, there were no clinically or statistically significant differences between groups at any timepoint up to, and including, 1 month for any of the primary or secondary outcomes measured. At 1 month, there was no significant difference between the treatment and control groups on either the Roland Morris Disability Questionnaire or the pain rating. One patient in the vertebroplasty group had an injury to the thecal sac during the procedure, resulting in the patient requiring hospitalisation. The negative findings of these two trials are supported by the findings of two open randomised trials of vertebroplasty versus usual care.8,9 One of these included 34 participants, and allowed crossover to the vertebroplasty group after 2 weeks in cases of persisting pain.8 At 2 weeks, the mean pain scores were similar between the two groups. The other open randomised trial included 50 patients who had had a short duration of symptoms (40 patients, < 2 weeks; 10 patients, 2–8 weeks).9 Outcomes at 3 months indicated no differences between the vertebroplasty and usual care groups for any of the measured endpoints. There were two adjacent fractures in the group that underwent vertebroplasty and none in the usual care group. These trials provide the best evidence we have to date on the value of vertebroplasty for treating painful osteoporotic vertebral fractures. Based on these data, vertebroplasty appears to confer no benefit over placebo, but poses some risk. Apart from the immediate risks of cement leakage, infection and injury to the spinal cord, vertebroplasty may increase the risk of further vertebral fracture. Both the Australian and US studies are ongoing, and will provide valuable additional data on this risk. Lower-quality studies are often biased in favour of interventions that are later shown in high-quality controlled trials to be ineffective.10 Findings from our two methodologically rigorous, randomised placebo-controlled trials show, not for the first time, the importance of establishing the efficacy of new procedures in well conducted, appropriately designed clinical trials before they are widely promoted and adopted into clinical practice. In light of the new evidence, the decision to list vertebroplasty for the treatment of osteoporotic vertebral fractures on the Medicare Benefits Schedule will be reviewed by the Medical Services Advisory Committee later this year. Treatment of painful vertebral fractures should continue to be best supportive care focused on pain management and maximising function. Attention to minimising risk of further fracture, including treatment of osteoporosis and other risk factors is also advisable. 1 Summary of the Australian randomised controlled trial of vertebroplasty6 National Health and Medical Research Council (NHMRC) Level of Evidence: II (randomised controlled trial) Location: Melbourne, Victoria Funding: NHMRC, Arthritis Australia, Cabrini Institute, Cook Australia Conclusion: Vertebroplasty was no better than placebo up to 6 months Description and findings 78 patients with one or two acute painful osteoporotic vertebral fractures confirmed unhealed by magnetic resonance imaging. 38 underwent vertebroplasty, and 40 underwent a placebo procedure simulating the real procedure. Follow-up was complete to 6 months for 71 of 78 patients (91%). The primary endpoint was overall pain over the course of the previous week (on a numerical scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months. Median duration of pain was 9.5 weeks for the vertebroplasty group and 9 weeks for the placebo group. Pain reduced in both groups over time. No differences between treatment groups were observed for any measures at any time point. At 3 months, the mean reduction in pain was 2.6 points (SD, 2.9) in the vertebroplasty group and 1.9 points (SD, 3.3) in the placebo group (adjusted between-group difference, 0.6; 95% CI, − 0.7 to 1.8). There were seven incident clinical vertebral fractures (three in the vertebroplasty group and four in the placebo group) over 6 months. One patient who underwent vertebroplasty and developed a new adjacent fracture also developed osteomyelitis. 2 Summary of the Mayo Clinic-based randomised controlled trial of vertebroplasty7 National Health and Medical Research Council Level of Evidence: II (randomised controlled trial). Location: Mayo Clinic in the United States (primary site); sites in the United Kingdom and in Sydney, New South Wales. Funding: National Institutes of Health. Conclusion: Vertebroplasty was no better than placebo up to 1 month. Description and findings 131 patients with one to three acute painful osteoporotic vertebral fractures confirmed unhealed by magnetic resonance imaging. 68 underwent vertebroplasty and 63 underwent a sham procedure. Crossover was allowed at 1 month if desired. Primary endpoints were the modified Roland Morris Disability Questionnaire (on a numerical scale of 0 to 23, with 23 being the maximum possible disability) and patients’ ratings of average pain intensity during the preceding 24 hours (on a numerical scale of 0 to 10, with higher scores indicating more severe pain) at 1 month. Median duration of pain was 16 weeks for the vertebroplasty group and 20 weeks for the placebo group. Pain reduced in both groups over time. No differences between treatment groups were observed for any other measures at 1 month. At 1 month, there was no significant difference between the vertebroplasty and control groups on either the Roland Morris Disability Questionnaire (difference, 0.7; 95% CI, − 1.3 to 2.8) or the pain rating (difference, 0.7; 95% CI, − 0.3 to 1.7). One patient who underwent vertebroplasty had an injury to the thecal sac during the procedure that made hospitalisation necessary.

Rachelle Buchbinder MB BS(Hons), PhD, FRACP · Richard H Osborne BSc, PhD · David Kallmes MD

Objective: To compare the clinical effectiveness of point-of-care testing (PoCT) with that of pathology laboratory testing, as measured by patients’ adherence to medication.Design: Multicentre, cluster randomised controlled trial using non-inferiority analysis. Medication adherence was assessed twice (in April 2006 and January 2007) by a self-administered questionnaire using the five-item Medication Adherence Report Scale (MARS-5).Setting: 53 Australian general practices in urban, rural and remote areas across three Australian states, September 2005 to February 2007.Participants: 4968 patients with established type 1 or type 2 diabetes, established hyperlipidaemia, or requiring anticoagulant therapy were recruited to the study. Of these, 4381 were included in the analysis (2585 in the intervention group and 1796 in the control group).Intervention: The intervention group (3010 patients in 30 practices) had blood and urine samples tested using PoCT devices within their general practices. The control group (1958 patients in 23 practices) had samples tested by their usual pathology laboratories.Main outcome measures: The proportion of questionnaire responses indicating medication adherence overall and by condition.Results: PoCT was non-inferior to pathology laboratory testing in relation to the proportion of questionnaire responses indicating medication adherence (39.3% v 37.0%) (difference, 2.3% [90% CL, – 0.1%, 4.6%]; P < 0.001). Non-inferiority could also be concluded separately for patients with diabetes (38.5% v 37.3%) (difference, 1.2% [90% CL, – 2.5%, 5.0%]; P = 0.01); hyperlipidaemia (38.3% v 37.3%) (difference, 1.0% [90% CL, – 1.5%, 3.5%]; P < 0.001) and for patients requiring anticoagulant therapy (44.5% v 41.4%) (difference, 3.1% [90% CL, – 2.1%, 8.3%]; P = 0.01).Conclusions: Having access to immediate test results through PoCT is associated with the same or better medication adherence compared with having test results provided by a pathology laboratory. PoCT used in general practice can provide general practitioners and patients with timely and complete clinical information, facilitating important self-management behaviours such as medication adherence.Trial registration: Australian Clinical Trials Registry ACTRN 12605000272695.

Angela Gialamas BHSc · Lisa N Yelland BMathCompSc(Hons) · Philip Ryan MB BS · Kristyn Willson BSc(Hons) · Caroline O Laurence BA(Hons), MHSM, PhD · Tanya K Bubner BSocSc(HumServ), GradDipHlthServMan · Philip Tideman MB BS, FRACP · Justin J Beilby MB BS, MD, FRACGP

Objective: To determine whether a surveillance program including clinical breast examination (CBE) and three screening modalities (magnetic resonance imaging [MRI], high-resolution ultrasound [U/S] and mammographic x-ray [MMX]) was feasible, and whether it could improve detection of pathological lesions in young women at high risk of developing breast cancer.Design, setting and participants: Western Australian women aged 50 years or under at high risk of developing breast cancer were recruited to our study. For a 2-year period, they were offered breast MRI and U/S scans in addition to their annual MMX and CBE. Our study was conducted between June 2002 and October 2005.Main outcome measures: Number and type of cancerous or precancerous lesions; recall rates after screening; comparative sensitivity of screening modalities.Results: Of 102 women approached, 72 agreed to participate. Fifteen lesions were detected, of which three were significant: a metastatic papillary cancer in an axillary lymph node, a borderline lesion (multiple papillomatosis with atypia), and a papilloma. All 15 lesions were visible on MRI, and four were detected by MRI only. Only one lesion was visible on all three imaging modalities. Nothing significant was detected by CBE. The recall rate after MRI scans fell from 9/72 (12.5%) in the first year to 5/67 (7.5%) in the second year.Conclusion: Our study gave valuable experience in a team approach to screening MRI, and showed that MRI can detect more lesions than MMX or U/S in women at high risk of developing breast cancer. Screening U/S may not add value to MMX and MRI screening, and we suggest a single oblique-view MMX may be used in some cases.

Christobel M Saunders MB BS, FRCS, FRACS · Gudrun Peters FRANZCR · Glenys Longman RN · Jacqueline Thomson MB ChB, FRANZCR · Donna Taylor MB BS, FRANZCR · Jianmin Hua BSc · Michelle Bennett MB ChB, FRANZCR · Elizabeth Wylie MB BS, FRANZCR · Jack Goldblatt MB BS, MD, FRACP · Arlene Chan MB BS, FRACP, MMed · James Anderson MB BS, FRANZCR

A 65-year-old woman underwent integrated fluorodeoxyglucose positron emission tomography and computed tomography (FDG-PET/CT [Philips GXL, Philips Medical Systems, Milpitas, Calif, USA]) to stage a newly diagnosed squamous cell carcinoma of the tongue (Figure, A). The scan revealed two additional, unexpected synchronous tumours, one in the left axilla (B) and the other in the sigmoid colon (C). The patient underwent subtotal glossectomy, after which further investigations confirmed a node-positive neuroendocrine carcinoma of the left breast and a dysplastic colonic tubulovillous adenoma. The detection of three synchronous tumours of different aetiology in the one patient on PET is rare. Previous cases of synchronous tumours detected on PET involved tumours of the head and neck, upper gastrointestinal tract and lungs, thought to be related to shared risk factors, such as smoking.1

Paul M Leong · Michael Lin · Allan R Fowler

Objectives: To determine whether redesign of pathology processes, including indicators of sample priority, could reduce patient length of stay (LOS) in an emergency department (ED), and assess the long-term impact of two indicators of sample priority on pathology clinical performance indicators for ED samples.Design, setting and participants: Two observational studies of de-identified data from standard databases were conducted — a single-site pilot trial of patients attending the ED of one hospital compared with historical controls, and a multisite study of 132 521 full blood count (FBC) requests for patients attending seven EDs that utilised either of two pathology process changes (coloured specimen transport bags alone, or coloured specimen bags plus blood tubes with a priority indicator).Main outcome measures: LOS in the ED was measured for the pilot trial, and collected-to-validated times for FBCs that fulfilled computer algorithm validation rules were measured for the multisite study.Results: In the pilot trial, the redesigned pathology process resulted in a 29-minute reduction (15.6%) in the median ED LOS for all patients (P < 0.001) compared with historical controls. In the multisite study, use of coloured specimen bags plus blood tubes with a priority indicator resulted in an 8-minute reduction (20.1%) in mean collected-to-validated times for FBC requests compared with FBC requests that used coloured specimen bags alone (P < 0.001).Conclusions: Our pilot trial revealed a direct relationship between pathology process design and LOS in the ED, suggesting that redesigned pathology processes can significantly reduce LOS in the ED. Our multisite study showed that collecting samples directly into blood tubes with an incorporated priority indicator reduces pathology test turnaround times. These data suggest that LOS in the ED can be significantly reduced by simple changes to pathology processes, such as collecting samples directly into specimen containers with an incorporated priority indicator.

Andrew J Francis MB BS(Hons), FRCPA · Michael J Ray PhD, BAppSc(Medical Technology) · Mary C Marshall BAppSc(Biology), GradDip Professional Communications

Objective: To identify potential weaknesses in the system of managing warfarin therapy.Design, participants and setting: A structured interview-based study of 40 community-dwelling patients taking warfarin and with an international normalised ratio ≥ 6.0 and 36 of their treating doctors (35 general practitioners and 1 specialist), conducted between July and November 2007. Patients all received services from and were recruited sequentially by a large, private metropolitan pathology provider in Melbourne.Main outcome measures: Patients’ demographic, clinical, cognitive and psychosocial characteristics, warfarin knowledge, medication complexity and adherence; and doctors’ experience with, approach to and involvement in warfarin management, and their perception of responsibility for warfarin management and patient education.Results: Interviews revealed multiple difficulties, including cognitive dysfunction, possible depression, and medication non-adherence, in 30 of 40 patients. Of 36 doctors interviewed, 12 were unaware of these difficulties in their patients. Five doctors considered they had sole responsibility for their patients’ anticoagulation, while 15 confirmed a mutual relationship with the pathology service, and 16 deferred total responsibility to the pathology provider. Only 14/36 doctors reported conducting patient education at commencement of warfarin therapy, with the other 22 stating this was the responsibility of the initiating specialist, pathology service or dispensing pharmacist.Conclusions: There is a need for improved role clarification in coordinating warfarin management. We propose exploring the possibility of a Warfarin Suitability Score to assist better recognition of patients in whom treatment may be problematic, along with a model of care using practice nurses with GPs to facilitate optimal patient care.

Judy A Lowthian BAppSci(SpPath), MPH, LMusA · Basia O Diug BBioMedSci(Hons) · Sue M Evans BN, GradDipClinEpi, PhD · Ellen L Maxwell MB BS, FRACP, FRCPA · Alison M Street MB BS, FRACP, FRCPA · Leon Piterman MMed, MEdSt, FRACGP · John J McNeil PhD, FRACP, FAFPHM

Objective: To compare the clinical effectiveness of point-of-care testing (PoCT) and that of pathology laboratory testing, as measured by therapeutic control in chronic conditions.Design: Multicentre, cluster randomised controlled trial using non-inferiority analysis.Setting: 53 Australian general practices in urban, rural and remote areas across three Australian states, September 2005 to February 2007.Participants: 4968 patients with established type 1 or type 2 diabetes, established hyperlipidaemia, or taking anticoagulant therapy.Intervention: The intervention group (3010 patients in 30 practices) had blood and urine samples tested by PoCT devices in their general practices, and the control group (1958 patients in 23 practices) had samples tested by their usual pathology laboratories. Main outcome measures: The proportion of patients and of tests with results in the target range, and change in test results from baseline.Results: For the proportion of patients with results in the target range, PoCT was found to be non-inferior to pathology laboratory testing for measuring glycated haemoglobin (HbA1c), urine albumin, albumin–creatinine ratio (ACR), total cholesterol and triglyceride levels but not for high-density lipoprotein (HDL) cholesterol level and international normalised ratio (INR). For the proportion of tests with results in the target range, PoCT was found to be non-inferior to pathology laboratory testing for measuring all variables except HDL cholesterol. For the proportion of patients showing an improvement in their test result from baseline, PoCT was non-inferior to pathology laboratory testing for HbA1c, total cholesterol and triglyceride levels, but not for HDL cholesterol level.Conclusions: This study provides important evidence for those considering the introduction of PoCT into general practice. For all tests except INR and HDL cholesterol, the PoCT approach demonstrated the same or better clinical effectiveness than pathology laboratory testing.Trial registration: Australian Clinical Trials Registry ACTRN12612607000628448.

Tanya K Bubner GradDipHlthServMg, BSocSc(HumServ) · Caroline O Laurence PhD, MHlthServMg · Angela Gialamas BHSc · Lisa N Yelland BMa, CompSc(Hons) · Philip Ryan MB BS · Kristyn J Willson BSc(Hons) · Philip Tideman FRACP · Paul Worley MB BS, PhD · Justin J Beilby MD

To the Editor: A 71-year-old man presented with a firm erythematous painful swelling over the sternoclavicular region. He had undergone coronary artery bypass grafting (CABG) 18 months earlier. A chest x-ray showed the presence of sternal wires and mediastinal clips from the surgery, and pleural thickening in the right costophrenic angle. There were no focal abnormalities seen on the x-ray when compared with pre-CABG radiographs. A computed tomography scan of the chest showed a destructive lesion of the manubrium, with an associated soft tissue mass extending into the pectoralis muscle and anterior mediastinum. A sternal suture was noted within the lesion, and a separate surgical clip was identified in the suprasternal notch region (Box, A). Surgical exploration of the sternotomy wound revealed tumour in the muscle around the proximal sternum, with bone destruction. Histopathological examination of the tumour confirmed the presence of an osteosarcoma (Box, B). (A section of normal trabecular bone [Box, C] is shown for comparison.) There have been few reported cases of primary sternal tumours. To our knowledge, primary osteosarcoma arising contiguous to a surgical suture has never been reported. It is unknown why the osteosarcoma originated in the part of the sternum that contained the sternal suture rather than originating de novo in another part of the bony skeleton. Chronic localised sternal inflammation or mechanical irritation of the proximal sternum by the suture may have been contributory factors in triggering carcinogenesis in this uncharacteristic site.1 However, the effect of trauma and mechanical stimulation on development of primary cancers and their metastases has never been proven. Patients who present with bony tumours frequently have a history of previous trauma to the area where the tumour develops. While there have been numerous reports suggesting some relationship between trauma/chronic inflammation and oncogenesis,1-5 there is no evidence that a single incident of trauma can cause cancer. The combination of trauma, in-situ metal and malignancy after CABG is rare, and there are currently no grounds for suspecting a direct relationship between them. A: Computed tomography scan of the chest showing a destructive lesion in the cortex of the manubrium. A sternal suture, surgical clip and soft tissue mass are visible within the tumour (A = anterior, R = right). B: Histopathological section of osteosarcoma of the sternum. Pleomorphic and hyperchromatic cells are present in a disorganised immature bone matrix (osteoid) (haematoxylin and eosin stain; original magnification, × 20). C: Histopathological section showing normal trabecular bone of the sternum (haematoxylin and eosin stain; original magnification, × 2.5).

Laurence Weinberg · Joseph Mathew

To the Editor: The University of Sydney recently established a Chair of Radiology and appointed Professor Ming Wang as the first full Professor of Radiology in New South Wales. This long overdue appointment resulted from a bequest of Arthur Parker-Hughes, after whom the Chair is named. Likewise, it was largely through the generosity of Edgar John Rouse that the first university department of radiology in Australia was established at the University of Melbourne in 1965; I was appointed Foundation Professor. Considering the role of radiology in modern medicine, it is remarkable that to date in Australia, establishing Chairs of Radiology depends largely on private sponsorship. Soon after Roentgen’s discovery of x-rays in 1895, Scandinavian countries promoted the triad of medicine, surgery, and roentgenology, as it was then designated, as the basis of clinical management. Radiology departments were nurtured in their universities, and were leaders in research. European medical schools followed suit, and since about 1960, university radiology departments in the United States have been at the forefront of research. In Australia, university clinical departments developed relatively late, and, when they did, the Australian Universities Commission recognised the need to provide space and basic staffing for these new departments to achieve the desired academic standard.1 In recent decades, development of new university radiology departments has languished. Established in 1975, the radiology department at Flinders University closed in 2002. The radiology department at the University of Queensland began in 1977. Currently, medical schools rely on busy radiologists employed by teaching hospitals for academic input, and provide them with various adjunct titles. The range of diagnostic imaging modalities and interventional radiological procedures continues to expand, providing significant research opportunities. Medical science students should understand what is available, the benefits and limitations, inherent risks, and should appreciate the economic burden on the community from inappropriate use. Also, radiology provides an excellent means of teaching basic medical subjects, such as anatomy and pathology. Considering the importance of radiology in the health system, and how its academic status is recognised by leading overseas universities, surely it is reasonable that each medical school in Australia should include a department of radiology, or, at least, a full Professor of Radiology, financed primarily from within the university.

William S C Hare

A skeleton alleged to be that of Johann Sebastian Bach (1685–1750) was exhumed from a graveyard in Leipzig, Germany, in 1894, but its authenticity is not established. In 1895, anatomist Wilhelm His concluded from his examination of the skeleton and reconstruction of the face that it most likely belonged to Bach. In 1949, surgeon Wolfgang Rosenthal noticed exostoses on the skeleton and on x-rays of 11 living organists and proposed a condition, Organistenkrankheit, which he interpreted as evidence that the skeleton was Bach’s. However, our critical assessment of the remains analysis raises doubts: the localisation of the grave was dubious, and the methods used by His to reconstruct the face are controversial. Also, our study of the pelvic x-rays of 12 living professional organists failed to find evidence for the existence of Organistenkrankheit. We believe it is unlikely that the skeleton is that of Bach; techniques such as DNA analysis might help resolve the question but, to date, church authorities have not approved their use on the skeleton.

Richard H C Zegers MD, PhD · Mario Maas MD, PhD · A (Ton) G Koopman PhD · George J R Maat MD, PhD

Objective: To explore use of bone densitometry in Australia and to identify any sex and geographic differences, as a marker of osteoporosis diagnosis and care.Design and setting: Analysis of claims data from Medicare Australia in patients aged over 45 years during the period 2001–2005.Main outcome measures: Age-standardised rates of bone densitometry use, by sex and by metropolitan, rural or remote classification.Results: Bone densitometry use increased by 26% over the 5 years. Rates were lower for rural and remote populations, with people in capital cities about three times as likely to undergo the investigation as those in remote areas. The sex ratio for the rate of bone densitometry use (women to men) decreased from more than 6 : 1 in 2001 to 4 : 1 in 2005.Conclusion: Although the sex ratio for osteoporotic fracture is close to 2 : 1 (women to men), the sex ratio for testing is much higher, suggesting underuse of bone densitometry in men. Sex and rural inequities in use of the investigation need to be addressed as part of a national approach to reducing minimal trauma fracture.

Dan P Ewald FRACGP, MAppEpid, FAFPHM · John A Eisman FRACP, PhD, AO · Ben D Ewald BMed, MClinEpid, PhD · Tania M Winzenberg FRACGP, MMedSci(ClinEpid), PhD · Markus J Seibel MD, PhD, FRACP · Peter R Ebeling MB BS, MD, FRACP · Leon A Flicker MB BS, FRACP, PhD · Peter T Nash MB BS(Hons), FRACP