Topics
General medicine
Avoidable hospitalisation in Aboriginal and non-Aboriginal people in the Northern Territory
Incorrect graph and wording: In “Avoidable hospitalisation in Aboriginal and non-Aboriginal people in the Northern Territory” in the 18 May 2009 issue of the Journal (Med J Aust 2009; 190: 532-536), there was an error in Box 4 (Li et al). In the panels headed “25–44 years” and “45 years and over”, the lines representing Aboriginal and non-Aboriginal rates were transposed. The correct version of Box 4 appears here. In addition, in the second paragraph of the results section, the wording was potentially misleading. The paragraph should have read: “Although total average avoidable hospitalisation rates were higher in Aboriginal than non-Aboriginal people in the NT, the largest differences were observed in the age groups 25–44 and 45–64 years (Box 1).” 4 Trends in age-adjusted, avoidable hospitalisation rates by Aboriginality and age group, Northern Territory, 1998–99 to 2005–06
Shu Q Li MPH, MB, BNursing · Natalie J Gray MIPH(Hons), MB BS(Hons), BSc/LLB(Hons) · Steve L Guthridge MB BS, MPH, FAFPHM · Sabine L M Pircher MPH, BNutrDiet
Primary care management of otitis media among Australian children
Acute otitis media (AOM) is diagnosed on the basis of acute onset of pain and fever; a red, bulging tympanic membrane; and middle ear effusion. AOM is managed with analgesia (paracetamol or non-steroidal anti-inflammatory drugs). Antibiotic therapy is minimally effective for most patients; it is most effective for children < 2 years with bilateral otitis media and for children with discharging ears. National guidelines recommend antibiotic therapy for Indigenous children with AOM. Evidence for corticosteroids, topical analgesia and xylitol are scant. Otitis media with effusion (OME) is diagnosed as the presence of middle ear effusion (type B tympanogram or immobile tympanic membrane on pneumatic otoscopy) without AOM criteria. Well children with OME with no speech and language delays can be observed for the first 3 months; perform audiological evaluation and refer to an ear, nose and throat (ENT) specialist if they have bilateral hearing impairment > 30 dB or persistent effusion. Children with effusions persisting longer than 3 months can benefit from a 2–4-week course of amoxycillin. Chronic suppurative otitis media is a chronic discharge through a tympanic membrane perforation. It is managed with regular ear cleaning (dry mopping or povidone–iodine [Betadine] washouts) until discharge resolves; topical ear drops (eg, ciprofloxacin); audiological evaluation; and ENT review.
Hasantha Gunasekera DCH, FRACP, MIPH(Hons) · Tony E O’Connor AFRCSI, FRCS(ORL-HNS) · Shyan Vijayasekaran MB BS, FRACS · Christopher B Del Mar MD, FRACGP
Complications of otitis media in Indigenous and non-Indigenous children
In Australia, three to five children die each year because of otitis media complications, and 15 children will suffer permanent hearing loss each year as a result of otitis media. Extracranial complications occur most commonly, and include mastoiditis, cholesteatoma and otitis media with perforation. Intracranial complications are less common, and include meningitis, brain abscess and lateral sinus thrombosis. In Australia, approximately 60% of extracranial and intracranial complications of otitis media occur in children. The contrasting rates of childhood otitis media among Indigenous and non-Indigenous children have implications for the frequency and types of complications occurring in both groups. Otitis media with effusion and acute otitis media predominate among non-Indigenous children, whereas chronic suppurative otitis media (CSOM) occurs most commonly among Indigenous children. The incidence of mastoiditis in Australia is low by international standards (2/100 000 children), but cholesteatoma rates among Indigenous children in Australia are higher than previously estimated (up to 10% in CSOM). A high rate of chronic tympanic membrane perforation occurs among Indigenous children, estimated to be as high as 80%. Intracranial complications of otitis media are uncommon, but are potentially life-threatening and are more likely to occur among Indigenous than non-Indigenous children. Reduced access to medical care, lower socioeconomic status and remote living conditions mean that levels of early childhood hearing loss among Indigenous children are likely to be underestimated. This has implications for early childhood speech and language development and education.
Tony E O’Connor AFRCSI, FRCS(ORL-HNS) · Christopher F Perry MB BS, DTM · Francis J Lannigan MD, FRCS(ORL)(Ed), FRACS
New horizons: otitis media research in Australia
Otitis media affects nearly all children worldwide. Despite an enormous amount of research, our understanding of this common condition continues to be challenged. New pathogens involved in otitis media are still being identified. The importance of interactions between viral and bacterial infection and the role of new vaccines need to be clarified. The proposal that bacteria can become more resistant to therapy through biofilm formation and intracellular infection could have important implications for treatment. The most important clinical research findings have been summarised in systematic reviews. In developed countries, research supporting “watchful waiting” of otitis media with effusion and acute otitis media have had most impact on evidence-based clinical practice guidelines. Indigenous Australian children remain at risk of more severe otitis media. Research programs targeting this population have been well supported. Unfortunately, interventions that can dramatically improve outcomes have remained elusive. For children at high risk of otitis media, health care services should concentrate on accurate diagnosis, antibiotic treatment of suppurative infections, and scheduled follow-up of affected children. Despite the lack of recent studies, strategies to minimise the impact the hearing loss associated with otitis media are important. Improvements in education, hygiene practices, and living conditions are likely to reduce the incidence and severity of otitis media. Studies of these types of interventions are needed.
Peter S Morris MB BS, FRACP, PhD · Peter Richmond MB BS, FRACP · Deborah Lehmann MB BS, MSc · Amanda J Leach MAgSci, PhD · Hasantha Gunasekera DCH, FRACP, MIPH(Hons) · Harvey L C Coates AO, MS, FRACS
Does point-of-care testing lead to the same or better adherence to medication? A randomised controlled trial: the PoCT in General Practice Trial
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
What does it cost to establish a practice-nurses-led clinical trial in general practice?
Objective: To describe the processes and costs of engaging practice nurses (PNs) to establish a cluster randomised controlled trial (RCT) to study type 2 diabetes in general practice.Design, setting and participants: Descriptive study of the processes and costs of engaging PNs from 59 general practices in Victoria that were participating in the Patient Engagement And Coaching for Health (PEACH) study, prior to practices being randomly assigned in the cluster RCT.Main outcome measures: Estimated direct research costs and personnel costs for establishing a general practice-based research project involving PNs (eg, costs for approaching Victorian Divisions of General Practice and the Australian Practice Nurses Association; practice and patient recruitment; research project establishment at general practices; and PNs’ training, support and engagement during the study establishment period).Results: The estimated cost to establish our PN-led general practice-based cluster RCT was over $110 000, with an average cost of $2000 per practice. Direct research and personnel costs were considerably higher than anticipated. Lack of research skills among PNs required intensive hands-on support from the research team.Conclusions: It is feasible to undertake a PN-led, general practice-based clinical trial in diabetes care. Future research funding needs to account for recruitment costs, including the need to build PN research capacity, and to overcome the inherent difficulties of engaging practices in complex intervention trials in primary care.Trial registration: International Standard Randomised Controlled Trial Number Register ISRCTN50662837.
Irene D Blackberry BMed, PhD · John S Furler FRACGP, GradDipPubHlth, PhD · Doris Young MB BS, MD, FRACGP · James D Best FRCPath, FRCP
Low drug doses may improve outcomes in chronic disease
The relationship between drug dose and clinical outcome has not been established for many medications used to treat chronic disease. Evidence is emerging that chronic diseases can be treated effectively with low doses. Adverse drug reactions account for significant morbidity and mortality and are generally dose related. Optimal drug dose — the best balance of benefit and risk — varies between individuals and may change over time. When treating chronic disease it is important to establish and maintain the optimal dose for each patient by close clinical monitoring.
Simon B Dimmitt MB BS, BMedSc(Hons), FRACP · Hans G Stampfer MB BS, FRANZCP
Adding weight to preconception care
Excessive maternal weight adversely affects all aspects of pregnancy and childbirth Weight and weight gain in pregnancy used to be an obstetric obsession, if not an oppression. Belief that weight restriction could prevent pre-eclampsia made scales the most feared instruments in antenatal clinics,1 causing some women to resort to fasting before their next appointment. Nearly 20 years ago, the routine use of scales started to diminish, in the same way as it had begun — without good evidence.1 Attention shifted to the weight of the offspring, and achieving birthweights within the 3000–4000 g bracket, which are associated with better perinatal outcomes.2 Evaluations of the resulting guidelines for weight gain in pregnancy2 (recently revised)3 also centred on birthweight, with less attention to more substantive perinatal and infant outcomes.4 The evaluations also showed that only a minority of women achieve an ideal weight gain;4 many gain more than is recommended, and excessive gain is most frequent in those who are overweight already.4 In the meantime, the childbearing population has changed considerably: growing in age, growing in weight, and growing in the expectation that none of this matters too much. In this issue of the Journal, two articles address different aspects of weight and pregnancy. Callaway and colleagues surveyed women about the preconception weight management advice they received, their self-perception of weight before pregnancy and their success with weight reduction.5 Jeffries and colleagues conducted a randomised controlled trial of an intervention to limit maternal weight gain during pregnancy.6 Callaway et al found that many women enter pregnancy blissfully unaware of their excessive adipose tissue,5 and presumably also of its effects on pregnancy. The study by Jeffries et al revealed that regular self-measurement of weight was effective in reducing pregnancy weight gain only in women who were overweight, but not obese, at the start of pregnancy.6 While it is disappointing that Callaway et al found that pre-pregnancy medical advice to lose weight was rare,5 one wonders how often doctors are rebuked for not acknowledging that “big is beautiful”. Alternatively, they may be constrained in their advice by their own body mass, or by simply not knowing how to translate weight reduction advice into meaningful action for their patients. Despite being innovative, the medical profession is often not an avant-garde movement known for tackling issues that do not fit within the routine framework of history, examination, diagnosis and treatment. It was only after obstetricians turned away from maternal weight control that fertility specialists turned to it,7 although their concern was more with achieving conception than with pregnancy and infant outcomes. Undoubtedly, the obesity pandemic has hit women of reproductive age particularly hard.8 The critical mass needed to initiate the menarche now comes earlier, but anything thereafter — from conception to pregnancy, childbirth, and perinatal outcome — up to the health of the next generation, is a different matter.9 An extensive body of literature, already overweight itself, testifies to the deleterious effects of excessive weight on conception rates (natural and assisted), pregnancy complications (mostly, gestational diabetes, pre-eclampsia and operative delivery, but also others), and fetal wellbeing (with increased rates of miscarriage, congenital malformations, stillbirth and perinatal death). Yet, the issue is not only the increased frequency of so wide a range of problems. It is also the weight-dependent increase in the challenges of diagnosis and management, not to mention the inherent complications of treatments, all of which add further fuel to the fire. Increased risks of fetal malformations are accompanied by greater difficulties of visualisation on ultrasound. Increased rates of late fetal death are compounded by reduced perception of fetal movements and the inadequacy of clinical examinations, including ultrasound and cardiotocography, in oversized individuals. Increased caesarean section rates are accompanied by greater challenges in gaining access to airways and the epidural space; increased operating times; greater blood loss; and a range of postoperative complications, including excessive bleeding, thromboembolism, impaired wound healing, wound dehiscence, urinary tract infection, and longer time to recovery. None of these ameliorate what is already common in obese mothers postpartum: failure to initiate and sustain breastfeeding, and postpartum depression, which have their own effects on giving infants who have survived earlier assaults a healthy start in life. Motivation on the part of pregnant women to protect their baby from unhealthy lifestyles and not to transmit these across generations is rarely lacking, but this is often an underutilised window of opportunity. It suffers from two main problems. First, and contrary to the wealth of evidence on the effects of obesity on pregnancy from its inception to its aftermath, there is remarkably little evidence on what can be done about it, as Jeffries et al noted.6 Second, the 9 months of pregnancy is too short a time for much to be achieved, especially for those at greatest need. Weight loss during pregnancy is not recommended. Recycling adipose tissue provides energy but few building blocks for fetal development, while the resulting ketoacidosis may harm the fetus. Re-introducing the terror of the scales (although worth considering for women who are unaware of their weight5) is probably not a solution. First, its effectiveness is limited, as Jeffries et al found.6 Second, although it reduces rates of fetal macrosomia and postpartum weight retention,4 it is too little too late for almost anything else. Third, it has the potential of adding insult to injury, victimising those who need ongoing support and assistance rather than repetitive lectures. Attention certainly needs to shift to preconception care, but further than preconception and fertility clinics.5,7 Too few attend them;5 half of all pregnancies are unplanned;5 and, when planned, there is usually too little time to produce substantial change. Contraception care may be better if it includes the question “what about afterwards?” and anticipatory guidance on the importance of weight, folic acid supplementation and planned pregnancy before instead of after stopping contraception. Like other pandemics that have hit maternity care in the past few decades, such as advanced maternal age and caesarean section rates, the obesity pandemic has roots that are deeper and longer than the 9 months of pregnancy.7,10 Digging them up will require more innovative strategies than we have witnessed thus far.
Marc J N C Keirse MD, DPhil, FRANZCOG
Keeping the doctor healthy: ongoing challenges
Despite positive changes to doctors’ working conditions, the stresses have changed rather than disappeared In the late 1970s, as a medical student in the United Kingdom, I attended a lecture from the then Dean of the medical school, Professor Neil Kessel. I recall him looking around at the 200 students assembled, and informing us that “Four of you will commit suicide”. That was, as I recall, the extent of our education about doctors’ health. Now, 30 years later, true to Professor Kessel’s foreboding, and despite his writings1 and the contribution of many others to an increasing body of knowledge and education about issues of physician impairment,2 four of my then colleagues have taken their own lives. Horrific though these mortality statistics may be, we also need to be cognisant of the considerable rates of morbidity among doctors. There have long been arguments about whether it is the stress of the job or the susceptible personalities that we bring with us to the profession that cause doctors to become stressed or psychiatrically unwell, or to develop substance misuse disorders. While we may be able to do little about the personalities of those attracted to careers in medicine, it is imperative that the stresses of the job and workplace are recognised, and that efforts are made to reduce them. For each cohort of medical students and doctors in training, the stresses of the previous generation may be modified, but they don’t disappear, and new ones are added. In theory, it is no longer permitted for registrars to stay up all night and then work the next day. In 1998, with the belated recognition that a disturbed sleep–wake cycle was good for neither patients nor doctors, and the establishment of the Safe Working Hours campaign,3 such practices are no longer defensible. However, doctors in training are not less stressed than those of previous generations; the stresses are different and often more intense, overlaid with the need for greater accountability, and the increasing militancy and litigiousness of consumers.4 In this issue of the Journal, we welcome two articles and a letter about doctors’ health and wellbeing. According to Heredia and colleagues, the intern year remains stressful despite reductions in hours and improvements in conditions.5 Self-report showed that 50% of interns thought medical school prepared them well for internship and, for most, internship was what they expected; but structured questionnaires showed that nearly 60% of interns had low levels of job satisfaction and, alarmingly, 18% regretted having studied medicine.5 Likewise, Markwell and Wainer found high rates of low job satisfaction and compassion fatigue among doctors in training, with 17% saying that, if they had their time over again, they would not have chosen medicine as a career.6 In the developmental trajectory of a doctor’s career, each phase brings its own set of challenges, and dissatisfaction with medicine as a career also appears to be significant among more senior doctors. A 2007 survey of what was deemed to be a representative sample of consultants in the British National Health Service found that 18% planned to retire early (before age 55), 32% were estimated to have psychiatric morbidity, and 17% reported drinking hazardous quantities of alcohol.7 The personal toll on doctors who are stressed, suicidal, burnt out or misusing substances must be appreciated; the effects on workforce planning of doctors underperforming or planning to give up medicine are also significant. Markwell et al found that most doctors in training report that their consultants and hospital administrations are supportive; this is encouraging, especially as it is in contradiction to the clinical experiences of working in a doctors’ health program. Here, some of the worst stresses experienced by doctors during their training (and later in their careers) are not those imposed by the system or training program, but come from the unsympathetic and judgemental attitudes of some more senior colleagues, who still see going through an intensely stressful training program as a rite of passage, or as preparation for tough times to come. Some of this stress is particularly stressful because it is personal and directed at individuals. It behoves us to treat our more junior colleagues with the same compassion that we show our patients. Postgraduate training for doctors has moved away from the apprenticeship model, making way for competency-based curricula. Trainees are under more scrutiny, and the stress of assessment is continual, with such evaluation tools as 360-degree assessment (multisource assessment with contributions from peers, other health professionals and patients) portfolios and formal evaluations in the workplace. The final exit examination may be less of a hurdle, but this comes at the price of doctors in training frequently being caught in a complex system where training requirements often conflict with workplace demands. The job is certainly stressful, but, as has been humorously pointed out, we as doctors need to admit the burden that we carry and find appropriate channels to “unload our baggage”.8 Authors of the third article on doctors’ health in this issue, Nash and colleagues, pose — and promise to explore in a future article — the important question of whether psychiatric morbidity is a cause or effect of medicolegal processes. However, they do find that those who work long hours are more likely to be involved in current medicolegal matters.9 Healthy doctors are more likely to have healthy patients. In order to keep doctors healthy, the ongoing challenges include not only continuing research into a changing group of issues, but integrating education programs into both undergraduate curricula and the workplace, and tackling workplace issues that may in part be best considered at the occupational health and safety level.
Kym D Jenkins FRANZCP, MPM, MEd
The health and wellbeing of junior doctors: insights from a national survey
Junior doctors face specific pressures related to their professional stage and development and can be at risk of poor health. A confidential survey conducted in 2008 by the Australian Medical Association Council of Doctors in Training investigated the health and wellbeing of junior doctors. There were 914 completed surveys: 71% of junior doctors were concerned about their own health, and 63% about the health of a colleague. A majority of junior doctors met well established criteria for low job satisfaction (71%), burnout (69%) and compassion fatigue (54%). The early stages of a medical career are demanding, and the health and wellbeing of junior doctors must be a personal priority, as well as the responsibility of the medical profession in general, to ensure a healthy medical workforce in the future.
Alexandra L Markwell MB BS(Hons), BSc · Zoe Wainer BM BS, BHSc
Bigger is not always better: what the National Health and Hospitals Reform Commission report means for general practice
The National Health and Hospitals Reform Commission report has a focus on building on “the vital role of general practice”, to strengthen primary health care as the “cornerstone of our future health system”. The report proposes Comprehensive Primary Health Care Centres and Services that will deliver “one-stop” primary health care; but in health care, bigger is not always better. The biggest challenge for the reform process may well be bringing together the different cultures of the largely private primary health care services, funded by the federal government, and the public, primary and community health services, funded by the states and territories. The report pays little real attention to the reforms needed to address the social determinants of health. There is a clear need for action now on the report’s most urgent recommendations for Aboriginal and Torres Strait Islander health, mental health, dental health and services for rural and remote communities. Diversity is a great strength of Australian general practice, and we must not lose it in the rush to reform.
Michael R Kidd AM, MD, FRACGP
Back pain: a National Health Priority Area in Australia?
To the Editor: On behalf of the Australian Association of Musculoskeletal Medicine (AAMM) and the Australasian Faculty of Musculoskeletal Medicine (AFMM), we would thank Briggs and Buchbinder for raising the topic of back pain as a National Health Priority Area (NHPA) for debate.1 The AAMM and its teaching arm, the AFMM, have been arguing for years that higher priority should be given to the management of low back pain, and we certainly support the arguments for making back pain an NHPA. We agree that back pain is a major burden on society, and that coordinated action that includes all stakeholders is required. Currently, members of the AAMM and AFMM are involved in contributing to the Australian Core Competencies in Musculoskeletal Basic and Clinical Science project,2 which aims to standardise the undergraduate teaching in musculoskeletal medicine around Australia. As well as supporting undergraduate initiatives, the AAMM and AFMM have been the significant providers of postgraduate education for doctors around Australia over the past 20 years, being engaged in activities that include the development of evidence-based guidelines and university-based postgraduate diploma and masters programs.3 It is then very disappointing to read disparaging comments about doctors with a special interest in musculoskeletal medicine. Briggs and Buchbinder assert that one potential disadvantage of making back pain a health priority is that it may provide “justification for those with . . . vested interests to promote clinically ineffective interventions”. The example they cite is a questionnaire survey of Victorian doctors in 2004, highlighting that a self-reported interest in low back pain or musculoskeletal medicine, or both, was strongly associated with back pain management beliefs and practices that are contrary to the best available evidence.4 The title of the Spine journal article4 is mischievous and misleading. The article implies that members of the AAMM have poorer knowledge about low back pain than doctors with no special interest in back pain. The real facts are that no attempt was made by the authors to specify what training or continuing medical education doctors had received, or whether they were members of the AAMM.
Victor J Wilk · Michael J Yelland · Michael B Oei
Back pain: a National Health Priority Area in Australia?
To the Editor: In the recent article by Briggs and Buchbinder, the authors propose that one advantage of including back pain as a National Health Priority Area (NHPA) is that it will increasingly encourage the management of back pain in accordance with best-practice clinical care guidelines.1 The emergency department (ED) is a key point of presentation for people with back pain. Research suggests that optimal management of low back pain incorporates multidisciplinary input, ensuring the provision of adequate analgesia and rational use of further investigations.2,3 On the basis of such data, we devised an interactive decision-support tool for completion by ED staff. The “Low Back Pain Assessment and Treatment” (LBPAT) guidelines were designed by a multidisciplinary team of nursing, medical, physiotherapy and pharmacy staff, based on accepted evidence-based standards of practice already in use.4 Use of these guidelines enables rapid assessment of “red flags” that may require further investigation and treatment. The guidelines include a flow diagram divided into three pain-management options for patients with mild, moderate or severe pain, with prompts for referral to physiotherapy and neurosurgery. The LBPAT guidelines indicate which imaging studies and blood tests may be required and when, as directed by findings. Information to assist discharge planning, including follow-up by a physiotherapist and general practitioner, and provision of information, is included. Once they were developed, we evaluated the effectiveness of the LBPAT guidelines in improving ED clinical practice. A retrospective case-record study of patients presenting to the ED and identified from International classification of diseases, ninth revision (ICD-9) codes (for back pain or low back pain) was undertaken before implementation of the guidelines (October–December 2006; 87 patients), immediately after implementation (May–August 2007; 96 patients), and about a year later (July–August 2008; 28 patients). Uptake of the LBPAT guidelines was only 47%–50% in both postimplementation periods. However, adherence to pain management guidelines improved significantly after implementation (59% [57/96] compared with 46% [40/87]; P = 0.02), and was maintained a year later (57% [16/28]). Use of aperients in patients who were coprescribed opiates was much improved in the period immediately after implementation (40% [27/68] compared with 16% [11/69]; P < 0.001) and 1 year later (70% [14/20]). Postimplementation data suggested a reduction in unnecessary blood tests (ie, no red flags requiring further investigation). For patients discharged from the ED, discharge planning and continuity of care did not improve immediately after implementation, but were greatly improved 1 year later. If back pain is included as an NHPA, use of a clinical decision tool such as the LBPAT guidelines is one potential method of preserving resources and improving patient outcomes in cases of back pain in the ED setting.
Stephanie K Vaughan · Julie L Gawthorne · Andrew S Finckh · Susan A Welch
Back pain: a National Health Priority Area in Australia?
In reply: The two preceding letters highlight that there are many stakeholders with an interest in back pain in Australia. Many craft groups are involved with the provision of postgraduate education and have contributed to the musculoskeletal core competencies initiative. Vaughan and colleagues describe promising results from using a clinical decision tool for acute back pain in an emergency department. On a national scale, implementation of such a tool in all emergency departments may significantly improve outcomes and reduce costs. Making back pain a national priority would provide unique opportunities to rigorously study these types of approaches. A timely illustration of our concern about vested interests potentially promoting ineffective or unproven interventions1 is the lively debate centred on the recently published United Kingdom National Institute for Health and Clinical Excellence guidance for the early management of persistent non-specific low back pain.2 The recommendation that injections of therapeutic substances into the back for non-specific low back pain should not be offered, as the evidence of effectiveness is lacking, led to the forced resignation of the president of the British Pain Society because of his refusal to denounce the guidelines he helped to formulate.3 To suggest that the title of the Spine journal article is misleading and mischievous is patently incorrect, as the title, “Doctors with a special interest in back pain have poorer knowledge about how to treat back pain”, simply summarises the main study findings.4 Based on 3831 responses from general practitioners in New South Wales and Victoria, collected in 1997, 2000 and 2004, doctors who reported a special interest in low back pain were significantly more likely to believe that patients with acute low back pain should be prescribed complete bed rest until the pain goes away (relative risk [RR], 1.89; 95% CI, 1.53–2.33); that they should not return to work until they are almost pain-free (RR, 1.55; 95% CI, 1.31–1.83); and that lumbar spine x-rays are useful in their work-up (RR, 1.36; 95% CI, 1.21–1.52). We also reject the suggestion that we made disparaging remarks about doctors with a special interest in musculoskeletal medicine. After adjusting for the presence of special interests in back pain, there were no important differences in back pain beliefs between those with and without a special interest in musculoskeletal medicine. While we cited a survey that found that Australian Association of Musculoskeletal Medicine (AAMM) members see a high caseload of patients with back pain,5 we made no claims about the knowledge base of AAMM members.
Rachelle Buchbinder · Andrew M Briggs
Coordination of care for patients with chronic disease
To the Editor: In their editorial commenting on our viewpoint article on Team Care Arrangements (TCAs), Harris and colleagues acknowledge a number of problems with TCAs and a lack of evidence for their effectiveness. However, they state that “the idea of team care still has merit” and that although there is “ample room for improvement in the current process”, they “cannot agree with Hartigan et al’s radical prescription to replace TCAs with patient summaries”.1 This seriously misrepresents our article. We did not suggest that TCAs should be replaced by patient summaries. We stated: “There are many elements in the solution to this problem, but one of primary importance is the development of a comprehensive patient summary”.2 Among these elements could be the one suggested by Harris et al — registration of patients in a shared database. However, a shared database would avail little if the patient information contained therein is not sufficiently comprehensive to permit development of well considered treatment objectives and priorities. The essential issue is whether TCAs are an improvement on the coordination that occurs under the traditional referral system. Coordination exists along a spectrum. At one end, it can be rigidly structured, with all participants having right of veto over action by any of the others. At the other end, it can be fluid and unstructured, with decisions over who should be involved in any particular management issue left to the good judgement of participants. By electing to impose on general practitioners a coordination model at the rigid end of this spectrum, the architects of TCAs appear to assume that GPs are usually unwilling, or cannot be bothered, to consult with other health professionals and must be made to do so. This is a massive assumption that demands very strong evidence. What is the evidence? And even if there were evidence, is coercion the answer? There is no doubt that coordination in care of patients with chronic illness is important and that it can be improved. However, improvements must be based on evidence and be practical. TCAs are neither.
Paul A Hartigan · Tuck Meng Soo · Marjan Kljakovic
Coordination of care for patients with chronic disease
In reply: We accept the clarification by Hartigan and colleagues of their article’s intent,1 and agree with the importance of good-quality information in electronic databases, especially if the information is to be exchanged. Unlike Hartigan et al, we do believe that Team Care Arrangements (TCAs) have some merit, as they provide structure for planned care and help coordinate access to multidisciplinary care provided over a period of time within the complexity of the current health system. However, they have not been very effective in developing trusting relationships and encouraging better communication between general practitioners and providers outside the practice because of a variety of systemic barriers. In our editorial, we suggested some alternative strategies.2 Although the paperwork and complexity of current requirements could be reduced, we cannot see that coercion is involved. Both patients and providers can choose to enter freely into TCAs and the requirements are for communication and consent, not for “right of veto over action”.
Mark F Harris · Bibiana C Chan · Sarah M Dennis
Knowledge on the move
Davidson’s essentials of medicine. J Alastair Innes, editor. Edinburgh: Churchill Livingstone Elsevier, 2009 (xii + 861 pp). ISBN 978 0 7020 3001 7. Davidson’s essentials is intended as a portable mini-textbook of medicine, primarily for medical students, for reference and reading while “on the move”. Although portable electronic formats such as PDAs may be good for reference purposes, they can be difficult to read or study from. Likewise, many existing handbooks use a list-based presentation that is not suitable for the novice learner seeking basic comprehension. Thus, Davidson’s essentials is a useful contribution that generally achieves the stated goals of its editor. It is a multi-authored work, but good editing means chapters have a consistent style and easy readability. A very useful feature is a one-page summary of the examination features for each organ system. This is a valuable learning tool that relates the presentation of each system to the examination of the actual patient. Indeed, each of these summary pages would make a good educational poster. The photographs are in colour and are generously sized. Tables and diagrams are used judiciously, and are educational rather than exhaustive. This is an excellent little textbook, but is by no means perfect. It fits easily into a bag, but is just a little too large and heavy to carry in the pocket. The chapter on emergencies and critical care is not long enough to give more than a cursory outline of shock, organ failure and resuscitation. Likewise, the discussion of geriatric syndromes is far too short for my liking. The last chapter gives sample OSCE (objective structured clinical examination) questions, but too few to be really useful; the book would not suffer if this final section were omitted. This book is definitely value for money, given the price of comparable handbooks. I recommend this for medical students beginning clinical work; allied health workers working in an unfamiliar area may find it useful for reference.
James Macdonald
General Practice Super Clinics — how will they meet their educational objectives?
The Australian Government will provide $275 million over 4 years to general practice infrastructure across Australia with the rollout of 31 General Practice Super Clinics. One of the core objectives of these Super Clinics is to support medical education. Several studies have demonstrated that the major barriers to teaching in general practice are time, space and money. We argue that General Practice Super Clinics can provide a responsive, flexible work culture; and improved payment and targeted resources to support the need for increased teaching capacity, and to attract and retain workforce for general practice and primary care.
Alistair W Vickery MB BS, FRACGP · Jennifer Dodd PhD, BASocSci(Hons) · Jon D Emery MB BCh, FRACGP, DPhil
Avoidable hospitalisation in Aboriginal and non-Aboriginal people in the Northern Territory
To the Editor: Li and colleagues analysed avoidable hospitalisation rates for Aboriginal and non-Aboriginal people in the Northern Territory, examined trends over time, and assessed “the implications for future primary care interventions”.1 Their study results confirmed that Aboriginal Australians in the NT experience significantly higher rates of avoidable hospitalisations than non-Aboriginal people. They also report a widening gap between avoidable hospitalisation rates of Aboriginal and non-Aboriginal people during the study period, 1998–99 to 2005–06. Avoidable hospitalisation rates are used nationally and internationally as an indicator of primary health care effectiveness and accessibility. However, debate continues about which conditions to include as “avoidable”, and the potential for errors in allocating and coding the primary diagnosis. Furthermore, serious methodological issues remain regarding the use of avoidable hospitalisation rates as an indicator of primary health care effectiveness and accessibility. The outcome measure “avoidable hospitalisation” is affected by more than just primary health care. This is acknowledged by Li et al,1 who identify other factors that affect hospitalisation, including disease prevalence and severity, and geographical remoteness.2 If these factors are not controlled for, it is not possible to attribute differences in hospital admissions to differences in quality of primary care. This would only be possible if Indigenous and non-Indigenous populations were similar in health status and residential location (and other important respects). Aboriginal people in the NT experience far higher rates of diabetes than non-Aboriginal Australians and the age of onset is far younger. For example, there is a 10% prevalence of diabetes in Aboriginal people aged 25–34 years residing in remote areas of the NT. This is 19.5 times the rate of diabetes in a sample of the Australian population of the same age (which will be close to the non-Indigenous rate in the NT), using data from the AusDiab study.3 This young Aboriginal population is also 18 times more likely to have multiple chronic conditions than the AusDiab group of the same age.3 Hospitalisation rates of a population with this health profile should be high, particularly if the primary care system is performing well. Even though Li and colleagues recognise the complexity of measuring primary health care effectiveness and access,1 they still attribute higher rates of avoidable hospitalisations to Aboriginal people’s lack of access to effective primary care. This simply cannot be deduced from their analysis, as it fails to adjust for the high and increasing incidence, prevalence and severity of chronic diseases in the NT Aboriginal population compared with the non-Aboriginal population. This type of misinterpretation of data is serious, given the potential policy implications. We agree that the research question is important, but it warrants a sophisticated analysis that properly adjusts for the most important confounders.
Odette R Gibson · Leonie Segal
Avoidable hospitalisation in Aboriginal and non-Aboriginal people in the Northern Territory
In reply: The national and international use of avoidable hospitalisations as an indicator of accessibility and overall effectiveness of primary care1 has included reporting differences in hospital admissions for different ethnic populations and across different geographical regions to highlight inequities in access to primary care. Avoidable hospitalisation rates are also routinely reported for the Aboriginal and Torres Strait Islander population.2 Currently, there is no “gold standard”, but compared with other indicators, such as self-reported data from population surveys, avoidable hospitalisation rates are regarded as an objective and robust measure of primary care.3 Despite the established use, there are well recognised limitations in the interpretation of avoidable hospitalisations, which are outlined in our article,4 and also raised in the letter by Gibson and Segal. What our article highlights, using well identified data sources, is the difference in avoidable hospitalisation rates between the Northern Territory Aboriginal and non-Aboriginal populations, as well as the very different trends. There are expectations that current reforms in the delivery of primary care for Aboriginal Australians can be directly monitored by improvements in avoidable hospitalisation rates. Our results highlight the need for caution in interpreting changes in these rates, and the substantial risks associated with unrealistic performance benchmarks.
Shu Q Li · Natalie J Gray · Steve L Guthridge · Sabine L M Pircher
Maximising the effectiveness and cost-effectiveness of cardiovascular disease prevention in the general population
We have a tool for absolute risk assessment — now we need a robust implementation program In March 2009, the National Vascular Disease Prevention Alliance (NVDPA), a consortium of Diabetes Australia, Kidney Health Australia, the National Heart Foundation of Australia, and the National Stroke Foundation, released evidence-based guidelines for assessing absolute cardiovascular risk.1 The guidelines are for use by health professionals who assess patients’ cardiovascular risk, primarily general practitioners. The risk charts that accompany the guidelines differ somewhat from the New Zealand risk charts,2 which are commonly used in Australia. Both the Australian and NZ charts are based on the Framingham Heart Study.3 The Australian cardiovascular risk charts are separated at the broader level into people with and without diabetes, rather than into men and women. In addition, systolic, but not diastolic, blood pressure is included because it is the stronger determinant of future events. The charts extend to upper cut-off points of 179 mmHg for systolic blood pressure and 7.5 mmol/L for total cholesterol level, respectively. The NVDPA guidelines also have an online risk calculator (http://www.cvdcheck.org.au). The new NVDPA guidelines and charts have the advantage of taking into account other drivers of practice in Australia, such as the Royal Australian College of General Practitioners’ Guidelines for preventive activities in general practice,4 and eligibility for Pharmaceutical Benefits Scheme subsidies for statins. Absolute risk assessment maximises the effectiveness of prediction of risk of future cardiovascular disease (CVD) events in people apparently free of such disease. This is because the underlying equations acknowledge fundamental epidemiological principles: risk depends on the range of independent risk factors and, for biomedical factors, risk typically increases in a log–linear manner above ideal levels (systolic blood pressure and total cholesterol level, 115 mmHg and 3.8 mmol/L, respectively).5 The present, somewhat arbitrary, definitions of hypertension and hypercholesterolaemia as ≥ 140/90 mmHg and ≥ 5.5 mmol/L, respectively, are fundamentally flawed, and most people who have CVD events have a clustering of risk factors with only modest abnormalities. If relative risk reduction with an intervention is relatively constant (the usual case), use of the intervention in those at higher absolute risk leads to greater absolute risk reduction and net benefit, thus also maximising cost-effectiveness. All absolute risk tools share some problems. As they are derived from large population studies, they are better at rank-ordering risk in subgroups and less precise in an individual. However, individual risk assessment may be refined (particularly in those initially assessed to be at intermediate risk) by measuring biomarkers or by imaging,6 and probably more so in the future, as more evidence becomes available. Other factors that might also be added to future algorithms include anthropometric measures (of these, waist circumference or waist : hip ratio appears more predictive than body mass index), a family history of premature atherosclerotic disease, and measures of socioeconomic deprivation.7 The NVDPA guidelines acknowledge that the Framingham risk equation may underestimate risk if these factors are present. The major determinant of CVD risk is increasing age, and it is also likely that equations specific for various age groups will become available. Particularly among younger people, this will improve identification of those with greater modifiable risk. Ideally, risk equations should be developed and validated in the local population. In Australia, algorithms for the general population have been developed from the Busselton8 and Dubbo9 studies. These are important contributions, although the relatively narrow endpoint (in Busselton) and the cohort age (in Dubbo) limit their application. How best can the NVDPA tools be used by practising clinicians? The first step is to identify high-risk groups. These include people with one or more of the following: prior CVD events, peripheral arterial disease, diabetes and age ≥ 60 years, chronic kidney disease, and familial hypercholesterolaemia. Such people should be treated accordingly and do not need absolute risk assessment. In all others, absolute risk assessments should commence at age 45 years, or 35 years for Aboriginal and Torres Strait Islander people, and be repeated at intervals reflecting the initial level of risk.1 An example of how to incorporate absolute cardiovascular risk assessment into management is given in the Box. What we now need is a robust implementation program. This makes economic sense. Recently, the National Health Service Health Check program was released in the United Kingdom.10 Everyone between 40 and 74 years, not already diagnosed with heart disease, stroke or kidney disease, will be invited, once every 5 years, to have their risk assessed using an absolute risk tool, and given support and advice to help them reduce or manage their risk. Analyses showed that this program would be very cost-effective compared with other accepted health interventions. The modelled cost-effectiveness ratio of this UK program is only £2480 per quality-adjusted life-year gained. Presently, in Australia, a Medicare item number supports a single health check for those aged 45–49 years. Although cost-effectiveness analyses are sensitive to the local health care system, the UK data strongly suggest that the current Medicare item number could be expanded, and other systems-based approaches implemented, to ensure that ongoing primary care risk assessments are supported, and that people at higher risk receive lifestyle and appropriate medical management. Implementation would be most likely to be effective if decision-support tools and recall mechanisms were used and incorporated into prescribing linked to electronic health records. Accompanying materials that appropriately communicate concepts of risk to patients would also be useful. The NVDPA is now developing a single CVD risk-management guide that will integrate the various specific risk-factor guides and make it easier to manage patients according to their absolute risk status. Absolute risk assessment does not replace the need to base all approaches to CVD prevention on lifestyle change. Studies have clearly shown the value of this, whether or not individuals are receiving blood-pressure or lipid-lowering therapies.11 However, absolute risk assessment leaves behind time-hallowed approaches based on individual risk factors, treated in silos, and often “dichotomised” to be regarded as “normal” or “abnormal”. It moves us forward to a more rational and effective paradigm for preventing our major health problem. How to incorporate absolute risk assessment into management using the Australian cardiovascular risk charts (the “People without diabetes” section of the charts is reproduced below) Example: Two women with similar risk profiles, but different ages Both women are smokers, without diabetes, with systolic blood pressure, 140 mmHg; total cholesterol : high-density lipoprotein cholesterol (TC : HDL) ratio, 7.2 mmol/L; and body mass index, 27 kg/m2. A is 46 years old and estimated to have a low risk (5%–9%) of developing cardiovascular disease (CVD) within 5 years. However, if she continues to smoke and to have a high TC : HDL ratio, she will place herself at high risk of prematurely developing CVD as she gets older. The chart can be used to demonstrate this to her. The priority intervention should be lifestyle advice, including smoking cessation, physical activity and healthy eating. B is 66 years old and estimated to be at high risk (20%–24%) of having a CVD event within 5 years. As a high priority, she should receive advice about smoking cessation and other lifestyle changes, as well as statin therapy. How to use the risk chart 1. Identify the chart relating to the person’s sex, diabetes status, smoking history and age. The charts should be used for all adults aged 45–74 years (and all Aboriginal and Torres Strait Islander adults aged 35 years or older) without known history of CVD or already known to be at high risk. 2. Within the chart, choose the cell nearest to the person’s age, systolic blood pressure (SBP) and total cholesterol (TC):HDL ratio. For example, the lower left cell contains all non-smokers without diabetes who are 35–44 years and have a TC:HDL ratio of less than 4.5 and a SBP of less than 130 mm Hg. 3. The colour of the cell that the person falls into provides their 5-year absolute cardiovascular risk level (see legend above for risk category). People who fall exactly on a threshold between cells are placed in the cell indicating higher risk. Charts are based on the NVDPA’s Guidelines for the assessment of absolute cardiovascular disease risk and adapted with permission from New Zealand Guidelines Group. New Zealand Cardiovascular Guidelines Handbook: A Summary Resource for Primary Care Practitioners. Second edition. Wellington, NZ: 2009. www.nzgg.org.nz. These charts are taken from Absolute cardiovascular disease risk assessment – quick reference guide for health professionals. © 2009 National Heart Foundation of Australia. Reproduced with permission. No further reproduction is allowed.
Andrew M Tonkin MD, FRACP, FCSANZ · Andrew N Boyden MPH, FRACGP · Stephen Colagiuri FRACP
Cardiovascular disease risk management for Aboriginal and Torres Strait Islander peoples in primary health care settings: findings from the Kanyini Audit
Objective: To describe cardiovascular disease (CVD) risk management in Indigenous primary health care.Design, setting and participants: Review of 1165 randomly selected case records of Indigenous Australian adults, aged ≥ 18 years, regularly attending eight health services in diverse settings in New South Wales, Queensland and Central Australia, October 2007 – May 2008.Main outcome measure: Adherence to CVD risk screening and management guidelines, especially with respect to overall or absolute CVD risk.Results: More than half the people in the sample (53%) were not adequately screened for CVD risk according to national recommendations. Underscreening was significantly associated with younger age, less frequent attendance, and lower uptake of the Medicare Health Assessment. Of the sample, 9% had established CVD, and 29% of those aged ≥ 30 years were classified as high risk according to the 2004 National Heart Foundation of Australia (NHFA) adjusted Framingham equation. Of those with CVD, 40% (95% CI, 30%–50%) were not prescribed a combination of blood pressure (BP) medicines, statins and antiplatelet agents, and 56% (95% CI, 49%–62%) of high-risk individuals without CVD were not prescribed BP medicines and statins. For high-risk individuals not prescribed BP medicines or statins, 74% (95% CI, 64%–84%) and 30% (95% CI, 23%–39%) respectively, did not meet 2004 NHFA criteria for prescribing of these medications, and of those already prescribed BP medicines or statins, 41% (95% CI, 36%–47%) and 59% (95% CI, 52%–66%) did not meet respective guideline targets.Conclusions: These management gaps are similar to those found in non-Indigenous health care settings, suggesting deficiencies across the health system. Prescribing guidelines which exclude many high-risk individuals contribute to suboptimal management. Guideline reform and improved health service capacity could substantially improve Indigenous vascular health.
David P Peiris MB BS, FRACGP, MIPH · Anushka A Patel MB BS, PhD, FRACP · Alan Cass MB BS, FRACP, PhD · Michael P Howard RN, MHN, MPH · Maria L Tchan BN, MPH · John P Brady BScApp · Joanne De Vries DipPHC · Bernadette A Rickards RN, MPH · Della J Yarnold MB · Noel E Hayman MB BS, MPH, FAFPHM · Alex D Brown BMed, MPH, FCSANZ
Gaps in cardiovascular disease risk management in Australian general practice
Objective: To evaluate the management of cardiovascular disease (CVD) risk in Australian general practice.Design, setting and participants: National cross-sectional survey of 99 Australian general practitioners participating in the Bettering the Evaluation and Care of Health (BEACH) program. Data on 2618 consecutive adult patients presenting to the participating GPs over a 5-week period from September to October 2006 were analysed.Main outcome measures: Proportions of patients screened, treated and reaching targets according to (1) current Australian CVD risk guidelines and (2) overall or absolute CVD risk.Results: Blood pressure (BP) had not been recorded for 13% of the sample. Of 1400 patients not prescribed antihypertensive medication, treatment was indicated for 8%. Of 821 patients already prescribed antihypertensive medication, 59% were achieving target BPs. Data on low-density lipoprotein (LDL) cholesterol levels were not available for 53% of the 2175 patients who should have had lipid screening according to the guidelines. Of 624 patients not prescribed a statin, treatment was indicated for 41%. Of 368 already prescribed a statin, 62% were achieving target LDL cholesterol levels. Sufficient data for calculation of absolute risk had been recorded for 74% of the 1736 patients for whom such calculation was recommended by the guidelines. The remaining 26% either had at least one required variable unmeasured (20%) or missing from the data collection (6%). For those at high absolute CVD risk (without established disease) and those with established CVD, 23% and 53%, respectively, had been prescribed both antihypertensive medication and a statin.Conclusions: Gaps between guideline recommendations and practice in recording and managing BP were relatively low compared with gaps for lipids. When stratified by absolute risk, patients at high risk of a cardiovascular event were found to be substantially undertreated.
Ruth J Webster BMedSc(Hons), MB BS(Hons), MIPH(Hons) · Emma L Heeley BSc(Hons), MSc, PhD · David P Peiris MB BS, FRACGP, MIPH · Clare Bayram BAppSc(HIM)(Hons) · Alan Cass MB BS, FRACP, PhD · Anushka A Patel MB BS, FRACP, PhD
Should aspirin be used for the primary prevention of cardiovascular disease in people with diabetes?
To the Editor: The ASPREE (ASPirin in Reducing Events in the Elderly) study may provide useful data on the benefits and risks of aspirin therapy in patients aged ≥ 70 years, as described by Woods and colleagues.1 However, the decision to allow general practitioner co-investigators to “help decide whether the patient is a suitable candidate for the placebo-controlled trial” introduces a source of selection bias that may limit the generalisability of the results. Without pre-specified objective selection criteria, it is likely that primary-prevention patients assessed by GP co-investigators as being at high vascular risk will be excluded because the GPs believe they should be taking antiplatelet agents. Similarly, those at low risk may be thought inappropriate participants because the risks of random allocation to this therapy might outweigh the perceived benefits, as has been shown in previous meta-analyses.2,3 ASPREE may end up with a disproportionate number of intermediate-risk patients. In the case of diabetes, a recent observational study from our group highlighted patients with diabetes and retinopathy and those taking a sulfonylurea as being at increased risk of complicated peptic ulcer disease.4 By contrast, we did not find that aspirin use, positive serological results for Helicobacter pylori, or the interaction of these two factors predicted complicated peptic ulcer disease. If GP co-investigators were aware of these findings, they might also influence the screening and recruitment of patients with diabetes to ASPREE. According to the trial registration details (ISRCTN83772183), patients with diabetes were eligible for recruitment to ASPREE from late February 2009, even though the trial started 6 years ago.5 Given this delayed eligibility, the fact that a substantial proportion of patients with diabetes older than 70 years will already have vascular disease, and the expected total sample size of 19 000,1 the trial might include fewer than 1000 patients with diabetes and thus have insufficient statistical power to assess the risks and benefits of aspirin for primary prevention in this important subgroup. We question why subjective assessment forms part of patient selection for a potentially important study such as ASPREE, and also what steps the investigators are taking to determine whether the sample they recruit is representative. In addition, details of planned statistical analyses involving diabetic participants in this non-superiority trial would be reassuring.
Timothy M E Davis · Brett A Sillars · Wendy A Davis
Should aspirin be used for the primary prevention of cardiovascular disease in people with diabetes?
In reply: Recruitment to clinical trials through general practice is representative of the population, as a high proportion of all Australians regularly attend their general practitioners.1 GP co-investigators are appropriate to decide whether their patients are suitable for the ASPREE (ASPirin in Reducing Events in the Elderly) study because their assessment includes objective inclusion and exclusion criteria that must be satisfied before enrolment in the study (clinical trial registration number ISRCTN83772183),2 as well as patient-specific potential risks with using aspirin, and known medical factors likely to influence patient survival during the trial. These include the risk of complicated peptic ulcer disease in patients with diabetes treated with a sulfonylurea.3 GP co-investigators support participation in ASPREE by eligible patients because of aspirin’s therapeutic equipoise for primary prevention in older patients4 and in those with diabetes.5 Because of age alone, ASPREE participants will be at least at intermediate risk of cardiovascular disease and also at increased risk of bleeding. Determining the aspirin balance underpins the importance of collecting more data in older people, who have been under-represented in previous primary prevention trials. ASPREE is a superiority trial with pre-specified subgroup analyses, including for the subgroup with diabetes.2 The study is powered to address the primary question reliably in the total cohort rather than subgroups. To date, fewer than 500 participants have been randomly allocated, with recruitment slowed subject to National Institutes of Health funding deliberations. Recruitment will be reinvigorated in late 2009, and will continue to include people with diabetes.
Robyn L Woods · Mark R Nelson · Andrew M Tonkin · Christopher M Reid