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Statistics Research 20 April 2009 Free

Perinatal exposure to HIV among children born in Australia, 1982–2006

Objective: To describe the pattern of perinatal HIV exposure and outcomes among children born in Australia, 1982–2006.Design and setting: National surveillance for perinatal HIV exposure.Participants: Women with HIV infection and their perinatally exposed children.Main outcome measures: Trends in the age-standardised rate of perinatal exposure, uptake of interventions by women with an antenatal HIV diagnosis, and rate of mother-to-child transmission.Results: Between 1982 and 2006, there were 354 reported cases of perinatal HIV exposure among children born in Australia. The age-standardised rate of perinatal exposure per 100 000 live births increased from 2.3 (1982–1986) to 5.1 (1991–1998), 9.9 (1999–2002) and 8.3 (2003–2006). Among children whose mother was diagnosed antenatally, the mother-to-child transmission rate declined significantly, from 25% (4/16; 95% CI, 7%–52%) in 1987–1990 to 5% (4/82; 95% CI, 1%–12%) in 2003–2006 (P < 0.001). The rate declined from 8% (4/51; 95% CI, 2%–19%) in 1987–1998 to 1% (2/151; 95% CI, 0.2%–5%) in 1999–2006 among children whose mother used at least two interventions. Mother-to-child transmission remained high among children born to women diagnosed postnatally (39/87, 45%; 95% CI, 34%–56%) and to women diagnosed antenatally who used no interventions (7/15, 47%; 95% CI, 21%–73%).Conclusion: The increasing rate of perinatal exposure and the decreasing rate of mother-to-child transmission among children whose mothers’ HIV infection was diagnosed antenatally were temporally associated with use of interventions for minimising mother-to-child transmission. Mother-to-child transmission remained high when the mother’s HIV infection was not known during pregnancy.

Ann M McDonald BSc, MPH · Yvonne A Zurynski PhD · Handan C Wand PhD · Michelle L Giles MB BS(Hons), FRACP · Elizabeth J Elliott MD, FRCP, FRCPCH · John B Ziegler MD, FRACP, FRCPCH · John M Kaldor PhD

Statistics Research 6 April 2009 Free

Bicycling injuries and mortality in Victoria, 2001–2006

Objective: To investigate the incidence of bicycling injuries and bicycle injury characteristics in the Victorian population.Design: Review of prospectively collected data.Setting: Bicycling injury data were extracted from four datasets for the period July 2001 to June 2006: (i) emergency department (ED) presentations from the Victorian Emergency Minimum Dataset; (ii) hospital admissions from the Victorian Admitted Episodes Data Set; (iii) major trauma cases from the Victorian State Trauma Registry (VSTR); and (iv) deaths from the National Coroners Information System.Main outcome measures: The profile and incidence of bicycling injuries across the datasets and years.Results: In the 5 years, 25 920 bicycle-related ED presentations were recorded, 10 552 bicyclists were admitted to hospital, 298 bicycling injuries were classified as major trauma (VSTR), and there were 47 bicycling fatalities. From 2001 to 2006, the incidence of bicycle-related ED presentations (incidence rate ratio [IRR] = 1.42; 95% CI, 1.37–1.48), hospital admissions (IRR = 1.16; 95% CI, 1.09–1.23) and major trauma (IRR = 1.76; 95% CI, 1.22–2.55) increased significantly. Most of those injured were males, aged < 35 years, with road-related injuries. Patients classified as having major trauma had a significantly higher incidence of trunk and head/face/neck injuries compared with those presenting to an ED or admitted to hospital.Conclusion: The incidence of serious bicycling injury has risen over recent years, highlighting the need for targeted prevention programs. Accurate data on cycling participation, use of injury prevention strategies, and injury profiles would assist in reducing bicycle-related injury.

Mirjana Sikic MB BS · Antonina A Mikocka-Walus MA(Psych), MA(Int Relations), PhD · Belinda J Gabbe BPhysio(Hons), MAppSc, PhD · Francis T McDermott MD(Monash), FRACS, FACS · Peter A Cameron MB BS, MD, FACEM

Statistics For debate 16 March 2009 Free

Non-inferiority trials: determining whether alternative treatments are good enough

New treatments that are potentially as effective as existing treatments are increasingly being developed, some of which may be preferred because of lower cost, fewer side effects, easier administration or less harm. Non-inferiority trials attempt to establish whether or not a new treatment — drug or non-drug — is no worse than an established treatment for which efficacy has been determined in placebo-controlled trials. Critical issues in the design and conduct of non-inferiority trials include: defining the acceptable margin of adverse events that, if exceeded, will render the new treatment inferior to the standard treatment (the non-inferiority margin); calculating the sample size needed to demonstrate non-inferiority; assessing the robustness of results in terms of absolute versus relative effects, intention-to-treat versus per-protocol analyses, one-sided versus two-sided statistical tests, and observed versus expected event rates for standard treatment; evaluating all relevant outcomes, including harm; and stating conclusions that are consistent with aims and results. Many non-inferiority trials fail to meet basic quality criteria, report biased and misleading conclusions, and are unduly influenced by commercial sponsors, with some commentators going so far as labelling them unethical. Clinicians and trial investigators need to exercise caution when interpreting results of non-inferiority trials which, because they lack a placebo group, can only provide an indirect assessment of the efficacy of a new treatment compared with an existing standard, and where the choice of non-inferiority margin can be highly subjective.

Ian A Scott FRACP, MHA, MEd

Ageing Letters 2 February 2009 Free

The changing face of the Australian population: growth in centenarians

To the Editor: There can be little disagreement with Richmond’s assessment that Australia needs more research on the oldest old.1 Certainly, data on centenarians are sparse and unreliable, and there is a need for more thorough and more informed evaluation. The 2006 census was the first recent census to record centenarians’ ages. The 2001 census recorded ages to “100 +”,2 while previous censuses had recorded ages to “99 +”.3 Pre-2006 centenarian percentage age distributions are non-validated “guestimates”.4 Further, the number of centenarians enumerated is questionable5 because of its dependence on age reporting, which suffers inaccuracies from proxy reporting, age exaggeration and rounding. Adjusted population estimates for mid 2007 include 2832 centenarians6 — considerably lower than the 2006 count of 3154 quoted by Richmond.1 Errors in centenarian numbers mean that census tabulations of centenarians’ characteristics (marital status, living arrangements) and derived demographic measures (sex ratios, growth rates) are unreliable. Mortality estimates are also affected. Alternative data, collected through administrative sources or special studies that verify birth and death dates, are needed to reliably estimate mortality in the oldest old and the probability of survival to 100 years and beyond. Richmond’s discussion of the “fastest growing age segment” does not make a clear distinction between growth in the proportion of the population who are centenarians and growth in the number of centenarians. Growth of centenarians as a proportion of total population depends on population structure. Relatively recent fertility declines will have had a similar effect on the proportion of the population aged 60–99 years as on centenarians. Reductions in infant, child and maternal mortality serve to increase the proportion of people who are in younger age groups and thus reduce the proportion who are centenarians. The recent rapid increase in the centenarian proportion is actually the combined effect of larger cohorts reaching old age and increased survival at older ages.7 In Australia, past migration is a major determinant of the relative size of different cohorts. Comparing the cohort aged 100–104 years in 2001 with the cohort of the same age in 2006 (the younger), births data show there were 11 300 more people at birth in the younger cohort.8 Large fluctuations in the difference between the sizes of these cohorts in the age range 25–84 years (from 20 100 to 43 300), calculated from successive population age distributions,9 demonstrate the influence of migration on relative cohort size. Whatever the effects of recent changes in fertility and mortality, historical determinants of population structure significantly influence the number of centenarians from one census date to the next. Two further factors apply to growth in numbers: first, it is easy to achieve a high growth rate for a small group, and second, the 100+ age interval is expanding (whereas younger age groups are of fixed width).

Heather Booth

Environmental health Enduring sport 19 January 2009 Free

The incidence of race-day jockey falls in Australia, 2002–2006

Objectives: To describe rates of occurrence of falls, injuries and fatalities to horse-racing jockeys in Australia.Design and setting: Retrospective analysis of data on race-day falls from stewards’ reports provided by the Principal Racing Authority of each state and territory of Australia, August 2002 – July 2006.Main outcome measures: Fall, injury and fatality incidence rates; comparison with overseas rates.Results: There were 3360 jockey falls from 748 367 rides. Falls occurred at a rate of 0.42 per 100 rides in flat races and 5.26 per 100 rides in jumps races. In flat racing, 54.6% (1694/3101) of falls occurred before the start of the race and 11.1% (344/3101) of falls occurred post-race. The 34.3% (1063/3101) of falls that occurred during flat races resulted in 61.7% (516/836) of the injuries sustained. In jumps racing, most falls occurred at a jump and 9.7% (25/259) of jockeys who fell were transported to hospital and/or declared unfit to ride. There were five fatalities resulting from falls during the study period, all in flat racing. Fall and injury rates were comparable with those found in the United Kingdom, Ireland, France and Japan.Conclusions: Being a jockey carries a substantial risk of injury and death. Although rates of injury in Australia are not exceptional by international standards, there can be improvement to safety standards in the Australian racing industry.

Peta L Hitchens BAppSci(Equine), MVPHMgt · C Leigh Blizzard PhD · Graeme Jones MMedSc, MD, FRACP · Lesley M Day BSc(Hons), MPH, PhD · James Fell BEd, MPhil, PhD

Sports medicine Enduring sport 19 January 2009 Free

Epidemiology of basketball and netball injuries that resulted in hospital admission in Australia, 2000–2004

Objective: To characterise injuries sustained in basketball and netball that result in hospital admission and to compare the profiles of injury between the two sports.Design and setting: Population-based retrospective descriptive epidemiological study using data from the National Hospital Morbidity Database, July 2000 to June 2004.Participants: Patients discharged from a public or private hospital with basketball or netball codes as the “activity when injured”.Results: There were 5090 basketball-related hospital admissions (mean patient age, 22.2 [SD, 10.7] years; 71.5% male) and 4596 netball-related admissions (mean patient age, 26.3 [SD, 10.9] years; 88.9% female). Fractures were the most common injury (46.8% [2384] of basketball-related and 29.5% [1358] of netball-related admissions), with the forearm and hand or wrist the most common fracture sites. The participant-based forearm fracture hospitalisation rate (5 + years age group) peaked in the 5–14-years age group. Anterior cruciate ligament rupture was the most common diagnosis, accounting for 760 (16.5%) netball-related admissions (mean [SD] age, 26.7 [8.4] years) and 354 (7.0%) basketball-related admissions (mean age, 25.5 [7.9] years). Achilles tendon injury accounted for 732 (15.9%) netball-related admissions (mean age, 35.2 [7.5] years) and 381 (7.5%) basketball-related admissions (mean age, 35.8 [7.8] years).Conclusions: The high rates of anterior cruciate ligament rupture and Achilles tendon injury resulting in hospital admission and their long-term consequences impact extensively on the individual and the community. The common injuries sustained in basketball and netball were strongly age-related.

Louise Flood MB BS · James E Harrison MB BS, MPH, FAFPHM

Data-mining of medication records to improve asthma management

Objectives: To use community pharmacy medication records to identify patients whose asthma may not be well managed and then implement and evaluate a multidisciplinary educational intervention to improve asthma management.Design, setting and participants: We used a multisite controlled study design. Forty-two pharmacies throughout Tasmania ran a software application that “data-mined” medication records, generating a list of patients who had received three or more canisters of inhaled short-acting β2-agonists in the preceding 6 months. The patients identified were allocated to an intervention or control group. Pre-intervention data were collected for the period May to November 2006 and post-intervention data for the period December 2006 to May 2007.Intervention: Intervention patients were contacted by the community pharmacist via mail, and were sent educational material and a letter encouraging them to see their general practitioner for an asthma management review. Pharmacists were blinded to the control patients’ identities until the end of the post-intervention period.Main outcome measure: Dispensing ratio of preventer medication (inhaled corticosteroids [ICSs]) to reliever medication (inhaled short-acting β2-agonists).Results: Thirty-five pharmacies completed the study, providing 702 intervention and 849 control patients. The intervention resulted in a threefold increase in the preventer-to-reliever ratio in the intervention group compared with the control group (P < 0.01) and a higher proportion of patients in the intervention group using ICS therapy than in the control group (P < 0.01).Conclusions: Community pharmacy medication records can be effectively used to identify patients with suboptimal asthma management, who can then be referred to their GP for review. The intervention should be trialled on a national scale to determine the effects on clinical, social, emotional and economic outcomes for people in the Australian community, with a longer follow-up to determine sustainability of the improvements noted.

Bonnie J Bereznicki BPharm(Hons) · Gregory M Peterson BPharm(Hons), PhD, MBA · Shane L Jackson BPharm(Hons), PhD · E Haydn Walters DM, FRCP, FRACP · Kimbra D Fitzmaurice BPharm · Peter R Gee BPharm(Hons)

Lower than expected morbidity and mortality for an Australian Aboriginal population: 10-year follow-up in a decentralised community

Objective: To examine mortality from all causes and from cardiovascular disease (CVD), and CVD hospitalisation rate for a decentralised Aboriginal community in the Northern Territory.Design and participants: For a community-based cohort of 296 people aged 15 years or older screened in 1995, we reviewed hospital and primary health care records and death certificates for the period up to December 2004 (2800 person-years of follow-up).Main outcome measures: Mortality from all causes and CVD, and hospitalisation with CVD coded as a primary cause of admission; comparison with prior trends (1988 to 1995) in CVD risk factor prevalence for the community, and with NT-specific Indigenous mortality and hospitalisation rates.Results: Mortality in the cohort was 964/100 000 person-years, significantly lower than that of the NT Indigenous population (standardised mortality ratio [SMR], 0.62; 95% CI, 0.42–0.89). CVD mortality was 358/100 000 person-years for people aged 25 years or older (SMR, 0.52; 95% CI, 0.23–1.02). Hospitalisation with CVD as a primary cause was 13/1000 person-years for the cohort, compared with 33/1000 person-years for the NT Indigenous population.Conclusion: Contributors to lower than expected morbidity and mortality are likely to include the nature of primary health care services, which provide regular outreach to outstation communities, as well as the decentralised mode of outstation living (with its attendant benefits for physical activity, diet and limited access to alcohol), and social factors, including connectedness to culture, family and land, and opportunities for self-determination.

Kevin G Rowley PhD · Kerin O’Dea PhD, AO · Ian Anderson MB BS, FAFPHM, PhD · Robyn McDermott FAFPHM, MPH, PhD · Karmananda Saraswati MB BS, FAMAC · Ricky Tilmouth · Iris Roberts EN · Joseph Fitz · Zaimin Wang PhD · Alicia Jenkins MD, FRACP · James D Best MD, FRACP, FRCPath · Zhiqiang Wang PhD · Alex Brown BMed, MPH, FCSANZ

Evidence-based recommendations for the diagnosis of ankylosing spondylitis: results from the Australian 3E initiative in rheumatology

As part of the 3E program, we conducted a systematic literature review and gathered consensus from 23 practising Australian rheumatologists to develop guidelines for early identification of ankylosing spondylitis and specialist referral. In three rounds of break-out sessions followed by discussion and voting, the specialist panel addressed three questions related to diagnosis of ankylosing spondylitis: In individuals with back pain, what are the early clinical features that suggest ankylosing spondylitis? How useful is imaging in identifying early ankylosing spondylitis? Based on which clinical features should a general practitioner refer a patient to a rheumatologist for further evaluation? The panel agreed on six recommendations related to the three questions: 1a. Early clinical features to suggest ankylosing spondylitis include inflammatory back pain and age at symptom onset < 45 years. 1b. The absence of symptomatic response to an appropriate course of non-steroidal anti-inflammatory drugs makes the diagnosis of ankylosing spondylitis less likely. 1c. Raised inflammatory markers are supportive, but their absence does not rule out the diagnosis of ankylosing spondylitis. 2a. Despite low sensitivity to detect changes of early ankylosing spondylitis, plain radiographs of the pelvis and spine are appropriate initial imaging techniques. 2b. Magnetic resonance imaging is a useful imaging modality for detecting early changes of ankylosing spondylitis. 3. Individuals with inflammatory back pain should be referred to a rheumatologist for further evaluation. Effective dissemination and implementation of these recommendations are important to standardise the approach to early diagnosis of ankylosing spondylitis.

Tracey Kain MB ChB, MPH · Jane Zochling MB BS, FRACP · Andrew Taylor MB BS, FRACP · Nicholas Manolios MB BS, FRACP · Malcolm D Smith MB BS, FRACP · Mark D Reed MB BS · Matthew A Brown MB BS, MD, FRACP · Lionel Schachna MB BS, FRACP, PhD

Environmental health The World Today 3 December 2007 Free

Morbidity and mortality during heatwaves in metropolitan Adelaide

Objective: To investigate morbidity and mortality associated with heatwaves in metropolitan Adelaide using ambulance, hospital admission, and mortality data.Design, participants and setting: Case-series study comparing health risks in the Adelaide metropolitan population during heatwaves and non-heatwave periods.Main outcome measures: Daily observations for ambulance transports (1993–2006), hospital admissions (1993–2006), and mortality (1993–2004), categorised using International classification of diseases (ninth and tenth revisions) codes for the relevant disease groups.Results: During heatwaves, total ambulance transport increased by 4% (95% CI, 1%–7%), including significant assault-related increases for people aged 15–64 years. Reductions were observed in relation to cardiac, sports- and falls-related events. Total hospital admissions increased by 7% (95% CI, − 1% to 16%). Total mental health admissions increased by 7% (95% CI, 1%–13%), and total renal admissions by 13% (95% CI, 3%–25%). Ischaemic heart disease admissions increased by 8% (95% CI, 1%–15%) among people aged 65–74 years. Total mortality, disease- and age-specific mortality did not increase, apart from a small increase in mental health-related mortality in people aged 65–74 years. Significant decreases were observed in cardiovascular-related mortality.Conclusion: In contrast to evidence from extreme heatwaves in the northern hemisphere, we found no excess mortality during heatwaves in metropolitan Adelaide, perhaps because of adaptive behaviour to regular hot weather spells. Projected temperature increases and evidence of modest increases in morbidity during heatwaves indicate the need for a heatwave response plan for Adelaide.

Monika Nitschke PhD, MPH · Graeme R Tucker BSc · Peng Bi MB BS, PhD

Emergency medicine Health care 19 November 2007 Free

A protocol-driven model for the rapid initiation of stroke thrombolysis in the emergency department

Objective: To assess efficacy and safety of a 24-hour comprehensive protocol-driven model for rapid assessment and thrombolysis of stroke patients in the emergency department.Design: Prospective open observational study.Participants and setting: All patients with acute stroke presenting within 3 hours to the St Vincent’s Hospital (Sydney) emergency department between 1 December 2004 and 30 July 2005.Main outcome measures: Proportion of patients treated, patient demographics, clinical outcome, adverse events and time to treatment parameters.Results: 134 patients (100 stroke; 34 transient ischaemic attack) were admitted to the stroke unit during the study period. Of the 100 stroke patients, 40 presented within 3 hours of symptom onset. Fifteen patients had no contraindications and received intravenous thrombolysis. At 3 months, 10 patients (67%) were independent (modified Rankin score [mRS], 0–2) and seven (47%) had an excellent functional outcome (mRS ≤ 1). Symptomatic intracranial haemorrhage was not observed. The median time from symptom onset to tissue plasminogen activator treatment was 155 minutes (range, 105–197 min). Median onset-to-door, door-to-computed tomography, and door-to-needle times were 48, 25, and 87 minutes, respectively.Conclusion: Rapid assessment of stroke in the emergency department according to a comprehensive protocol allows identification and treatment of acute ischaemic stroke patients eligible for thrombolysis.

Julia J Batmanian BSc(Med), MB BS(Hons) · Meeyin Lam BAppSc(Physio), MIPH · Caitlin Matthews BSc(Hons), MB BS(Hons) · Andrew Finckh MB BS, FACEM · Martin Duffy MB BS, MMed(ClinEdi), FACEM · Robert Wright FRACP, FFARACS, FJFICM · Bruce J Brew MB BS, MD, FRACP · Romesh Markus PhD, FRACP, MB ChB

Information science Medicine and the Media — Research 15 October 2007 Free

Choice and voice: obesity debates in television news

Objective: To examine whether television news and current affairs coverage of overweight and obesity frames obesity in ways that support or oppose efforts to combat obesity.Design and setting: A content and framing analysis of a structured sample of 50 television news and current affairs items about overweight and obesity broadcast by five free-to-air television channels in New South Wales between 2 May and 31 October 2005.Main outcome measures: Dominant discourses about causes of overweight and obesity; proposed solutions and location of responsibility for the problem; the age-group focus of television items; the relative prominence of stakeholders; and the aspects of obesity which attract news attention.Results: Most television items (72%) framed obesity as a problem of poor nutrition. Obesity was largely seen as the responsibility of individuals (66% of items). Just over half of news items (52%) focused only on adults while 26% focused only on children. Obesity was framed largely as a problem to be solved by individual nutritional changes, exercise and surgical and medical interventions.Conclusions: While individual lifestyle is crucial to controlling weight, the research community now recognises the importance of sociocultural and environmental factors as drivers of the obesity epidemic. However, television news portrays obesity largely as an individual problem with individual solutions centred mostly on nutrition. Media emphasis on personal responsibility and diet may detract attention from the sociopolitical and structural changes needed to tackle overweight and obesity at a population level.

Catriona M F Bonfiglioli BA(Hons), PhD · Ben J Smith BSW(Hons), MPH, PhD · Lesley A King BScPsych(Hons), MPsych · Simon F Chapman BA(Hons), PhD · Simon J Holding BA

Health services administration Health care 3 September 2007 Free

Health technology assessment in England: assessment and appraisal

The Health Technology Assessment (HTA) Programme in England is a government-funded but independent research program. It is “needs-led”, identifying technologies of most importance to the National Health Service and commissioning research to provide answers on these technologies useful to policymakers, clinicians and patients. It is “science-added”, refining problems to researchable questions and working with researchers to ensure that the question is addressed, and disseminating the findings to key audiences. There is a clear distinction in England between assessment (a scientific process and the role of the HTA Programme) and appraisal (the role of policymakers, like the National Institute for Health and Clinical Excellence). There are many features common to HTA in Australia and England, but also differences, as HTA in each country has to adapt to its own environment.

Tom Walley MD, FRCP, FRCPI

Health services administration Health care 3 September 2007 Free

An evaluation of methods used in health technology assessments produced for the Medical Services Advisory Committee

Objective: To examine the methods used in health technology assessments (HTAs) produced for the Medical Services Advisory Committee (MSAC) reviewing the effectiveness of a technology or procedure.Design and setting: Data were extracted from the effectiveness section of HTA application assessment reports published between 1 January 1998 and 17 July 2006 and available on the MSAC website. Only HTAs of effectiveness interventions were examined, as the methods used to undertake such reviews are well established.Main outcome measures: Variables reflecting methods used in the HTAs to evaluate the effectiveness of health technologies or procedures.Results: Of 56 MSAC HTA reports available, 31 met the inclusion criteria. Considerable variability was shown to exist between the various indicators of quality and the methodology used within the HTAs. Reports did not describe potential conflicts of interest of participants. The majority of reports (19/31) did not formally state the research question that the assessment was attempting to answer. Just over half of the reports (18/31) provided details of validity assessment of the included studies.Conclusions: Minimum and consistent standards of methodology and reporting are required in Australian HTAs, using international recommendations of best practice to increase the transparency and applicability of these reports.

Emily S Petherick BSc(PhysEd), MPH · Elmer V Villanueva MD, ScM · Jo Dumville MSc, PhD · Emma J Bryan BSc, PhD · Shyamali Dharmage MD, PhD

Statistics Research 6 August 2007 Free

Discordance between level of risk and intensity of evidence-based treatment in patients with acute coronary syndromes

Objectives: To examine the relation between treatment intensity and level of risk in routine hospital care of patients with acute coronary syndromes (ACS), and to identify independent predictors of use or omission for each of eight evidence-based treatments.Design: Retrospective cohort study of patients fulfilling case definition for ACS in whom absolute risk of adverse outcomes was quantified (as low, moderate, or high risk) using formal prediction rules, and for whom treatment eligibility was determined using expert-agreed criteria.Participants and setting: 3912 consecutive or randomly selected patients admitted to 21 hospitals in Queensland, Australia between 1 August 2001 and 31 December 2005.Results: The proportions of eligible patients receiving treatment varied inversely with risk level in regard to reperfusion therapies of fibrinolytic therapy or primary angioplasty (low risk, 88.3%; moderate risk, 61.9%; high risk, 18.2%; P < 0.001), heparin (91.4%; 83.7%; 72.8%; P < 0.001) and early invasive intervention (33.6%; 24.0%; 18.5%; P < 0.001). Significantly more low- and moderate- than high-risk patients received β-blockers (87.0%; 88.5%; 79.1%; P < 0.001), lipid-lowering agents (87.3%; 84.8%; 65.8%; P < 0.001), and referral to cardiac rehabilitation (51.8%; 46.0%; 34.4%; P < 0.001) at discharge. The most frequent independent predictors of treatment omission in all patients included increasing age (5 of 8 treatments), previous ACS or atrial tachyarrhythmias (4 of 8), and past history of cerebrovascular accident or congestive heart failure (3 of 8). Conclusion: In routine care of ACS, eligible patients at high risk receive treatment less frequently than those at low and moderate risk. Reforms in professional education, routine use of risk stratification tools, guideline recommendations tailored to population-specific reductions in absolute risk, and better hospital networking with standardised triage and referral procedures for invasive procedures may help reduce selection bias in the delivery of indicated care.

for the CPIC Cardiac Collaborative

Indigenous health Maternal and Child Health 21 May 2007 Free

The urban–remote divide for Indigenous perinatal outcomes

Objective: To determine whether remoteness category of residence of Indigenous women affects the perinatal outcomes of their newborn infants.Design and participants: A population-based study of 35 240 mothers identified as Indigenous and their 35 658 babies included in the National Perinatal Data Collection in 2001–2004.Main outcome measures: Australian Standard Geographical Classification remoteness category, birthweight, Apgar score at 5 minutes, stillbirth, gestational age and a constructed measure of perinatal outcomes of babies called “healthy baby” (live birth, singleton, 37–41 completed weeks’ gestation, 2500–4499 g birthweight, and an Apgar score at 5 minutes ≥ 7).Results: The proportion of healthy babies in remote, regional and city areas was 74.9%, 77.7% and 77.6%, respectively. After adjusting for age, parity, smoking and diabetes or hypertension, babies born to mothers in remote areas were less likely to satisfy the study criteria of being a healthy baby (adjusted odds ratio [AOR], 0.87; 95% CI, 0.81–0.93) compared with those born in cities. Babies born to mothers living in remote areas had higher odds of being of low birthweight (AOR, 1.09; 95% CI, 1.01–1.19) and being born with an Apgar score < 7 at 5 minutes (AOR, 1.63; 95% CI, 1.39–1.92).Conclusions: Only three in four babies born to Indigenous mothers fell into the “healthy baby” category, and those born in more remote areas were particularly disadvantaged. These findings demonstrate the continuing need for urgent and concerted action to address the persistent perinatal inequity in the Indigenous population.

Simon Graham BIS · Lisa R Jackson Pulver PhD, MPH, GradDipAppEpi · Yueping Alex Wang MB BS; MPH · Paul M Kelly DTM · Paula J Laws BA(Hons) · Narelle Grayson BA(Hons) · Elizabeth A Sullivan MB BS, MPH, MMed(Sexual Health)

Statistics Trials on trial 19 March 2007 Free

Interpreting the results of a clinical trial

In preparing an article reporting a clinical trial, the authors are expected to provide a reasoned interpretation of the results and place them into a broader clinical context. “Interpretation” (Item 20 of the CONSORT statement) refers to how the authors account for their results (Box 1).1 Although it has been suggested that authors often have a vested interest in their data and may be biased towards a positive result,2 they nevertheless have first-hand experience of the design and conduct of the trial, and can offer a unique insight into interpretation of the results. Elements of an interpretationAuthors are generally encouraged to summarise the extent to which the results and findings are consistent with their original hypothesis,3 and to comment on the robustness of the results for drawing conclusions and making recommendations. This should involve discussion of: the suitability of the study design to answer the questions examined; the ultimate quality of the trial as conducted; the extent to which missing follow-up or imputed data contributed to the reported results; and the potential influence of any protocol violations or other biases that may have affected the clinical experiment.4 Beyond this, specifically addressing the key aspects of internal validity (such as the fairness of the comparison of treatment groups in the trial) will help the reader assess the results. For example, the reader’s confidence in the results is increased by reassurance about the adequacy of randomisation,5 consistency across treatment arms of the methods used to measure outcomes,6 and similar levels of background care in the treatment arms. Additionally, if results are derived from multiple comparisons, the dangers of over-interpretation of a variety of endpoints should be acknowledged.7,8 Even if a study has strong internal validity, the results may be surprising or unexpected. Therefore, the plausibility of the results in relation to expectations, and speculation as to possible mechanisms of action of the intervention should be discussed.7 The sensitivity of the findings to any departures from the assumptions in the design (eg, compliance levels, unblinding, losses to follow-up, and missing data) should be mentioned.4 Any other limitations or drawbacks of the study design or conduct should be acknowledged, and their influence, or lack of influence, on the outcomes should be argued. This will help the reader to compare these results with other relevant findings. The strength of the findings (shown by P values and confidence intervals around the estimates) signifies their robustness. The size of the estimates of effect and their plausible variability (such as the risk reduction or hazard ratio and confidence intervals) show the potential importance of the intervention in clinical use. After validity has been discussed, the potential ramifications of the results are usually presented. These include the value of the intervention beyond the trial, including the likely generalisability of the findings,9 the balance of benefits and harms,10 and any potential changes to clinical practice that may be appropriate. How consistent the results are with other findings, and how biologically and clinically plausible the interpretation is, will influence this discussion. The results may raise new questions directing further research. These might arise from the findings for the main outcome, from a subset of patients, or from ancillary analyses. As the authors have an intimate knowledge of the study and the data, their views on the direction of such research may carry weight. Recommended structure of a DiscussionWe recommend an ordered structure for the Discussion section (Box 2). Statement of the findingsA simple declaration of the meaning of the results should introduce the authors’ interpretation. For example, the following sentence introduces the Discussion section of the LIPID study report:11 Our results provide strong evidence that lowering cholesterol levels with pravastatin in patients with a broad range of initial cholesterol levels and a history of myocardial infarction or unstable angina reduces the risk of death from CHD, cardiovascular disease, and all causes combined. What follows extends this discussion with a brief statement of which patient groups benefited, and the extent and nature of these benefits. Strengths and weaknessesThe strengths of the trial may include its representative sample, its rigorous design and its clinical relevance. The account of the weaknesses should aim to explain any flaws in the study identified by the authors, and outline the attempts made to minimise and compensate for these limitations. Identifying weaknesses in the study and discussing their likely influences will help readers appreciate the limitations of interpreting the study results. Discussion of weaknesses should include methodological aspects (eg, possible biases, the meaning of imprecision in the findings, and the number of multiple comparisons) as well as clinical aspects, such as any problem in translating statistical results to clinical importance. An example is the study comparing hot water immersion with ice packs to relieve the pain of bluebottle (Physalia jellyfish) stings in participants recruited from beach first aid facilities.12 Hot water immersion for 20 minutes, unlike ice, was highly effective. The Discussion described study weaknesses, such as bias: there was a possibility that, with simultaneous recruitment of family members, treatments could have been allocated after randomisation on the basis of severity. We suspect in some cases when two or three patients were simultaneously recruited (often one parent consenting for multiple children), the research assistants may have allocated hot water treatment to the more severe stings once the envelopes were open. However, this was likely to be rare, and a post-hoc analysis using simulations of matched treatment subgroups still showed a highly significant outcome at 20 minutes. The Discussion also dealt with the subjectivity of pain and the problems of choosing how to measure it. The measurement of pain is problematic because it is subjective and is influenced by numerous factors. However, pain is the most important and distressing effect of bluebottle stings, so it was essential that we establish the effect of treatment on pain. The VAS has become a standard tool for the measurement of pain in research, and has been validated in numerous settings. Mechanisms and explanationsIt is important that the authors consider all possible mechanisms underlying the results and explain how they might relate to the outcomes. For example, in the bluebottle study:12 It might be argued that the hot water immersion may be a symptomatic treatment for jellyfish stings, rather than providing definitive treatment by inactivating venom . . . We demonstrated a time-dependent effect of hot water immersion, with a barely significant effect at 10 minutes and a highly significant effect at 20 minutes. In addition, pain did not recur. This leads us to suggest that the mechanism of reducing pain by heat treatment is inactivation of venom. However, unlikely or implausible hypothetical mechanisms should not be proposed merely so that they can be disproven. Relation to other studiesAll clinical trials start from a background of previous work. Authors should indicate where results extend, agree with or differ from those of other studies (a forest plot may help readers with interpretation). If there are differences, are these related to differences in methods or the characteristics of participants? An important finding of the Women’s Contraceptive and Reproductive Experiences (CARE) Study was new evidence on breast cancer risk:13 In conclusion, high parity and early age at first birth were associated with a reduction in risk only for ER+PR+ tumours. Breastfeeding was associated with a reduction in risk for both ER+PR+ and ER–PR– tumours. Combined with previous research, this suggests that parity and age at first birth act through different mechanisms than breastfeeding. All reproductive factors showed similar associations with both ductal, ductolobular and lobular tumours, suggesting that these tumours have similar aetiologies. Implications for clinical practice and future researchReaders may not have the authors’ background and experience in the research area. Their own interpretations are aided by the authors’ commentary, which may include how far the results can be applied in different clinical situations. For example, in the Heart Protection Study:14 As people with blood creatinine concentrations above 200 μmol/L were excluded from the present study, further large trials are required to determine prospectively whether statin therapy can prevent clinically relevant changes in renal function among people at particular risk of developing end-stage kidney disease. Interpretations, not just interpretationMost clinical trial reports for publication draw together the expertise and interests of several authors, and the Discussion section is where their views are most likely to diverge. Authors bring different perspectives to interpreting the results.15 The Discussion needs to reflect a consensus view of all the contributors. 1 CONSORT checklist of items to include when reporting a randomised trial1 Section and topic Item no. Descriptor Discussion Interpretation 20 Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes 2 Suggested framework for the Discussion section A brief statement of the findings; Strengths and weaknesses (limitations) of the study, and methods used to minimise and compensate for the limitations; Possible mechanisms of action of the intervention, and explanations of these mechanisms; Comparison with relevant findings from other published studies; Clinical and research implications of the work, as appropriate.

Anthony C Keech FRACP, MSc(Epi) · Rhana Pike MA, ELS · Renee E Granger BA, BSc(Hons) · Val J Gebski BA, MStat

Statistics Letters 19 March 2007 Free

Mistakes and misconduct in the research literature: retractions just the tip of the iceberg

To the Editor: Post-publication audits of the quality of medical research studies are vitally important. I support the conjecture of Nath et al1 that the small number of retractions for mistakes and misconduct (about 20 per year for articles published between 1982 and 2002) represents the tip of the iceberg. I recently wrote a systematic review of studies (published between 1972 and 2005) of growth in children taking stimulant medication for attention deficit hyperactivity disorder (ADHD), and I was astounded by the poor quality of much of the research.2,3 Of the 22 studies reviewed, I felt that 11 were flawed, either because their conclusions were not fully supported by the data, or because of poor methodology, or both. Some had quite subtle mistakes or misinterpretations, such as failure to consider that a child’s height velocity might vary with duration of treatment (two studies). Others were more obvious; for example, a study with a design that introduced systematic errors. Two studies had negative findings associated with inappropriate controls; however, in both of these studies the suitability of the control data was fully discussed. Two studies appeared underpowered, but a full assessment of this could not be made because some of the essential information was either insufficiently detailed or completely lacking. There were three studies lacking any rigorous comparison with control data on which to base their conclusions. I did not detect any trend for studies with unsupported conclusions or flawed methodology to be published in journals with higher impact factors (median impact factor in both groups, 3.9), suggesting that, while these journals might report a higher rate of retractions (as found by Nath et al1), it may not necessarily reflect a higher rate of mistakes or misconduct among their authors. Likewise, the number of authors and level of funding — pharmaceutical industry or otherwise — appeared to be similar between studies whose conclusions were judged as valid or invalid. Nearly all of the more rigorously designed studies showed statistically significant slowing of growth in height during the first 1–3 years of treatment with stimulant medication.2 By contrast, the flawed studies as a group supported the notion that stimulant medication does not have any statistically or clinically significant effect on growth in height, the individual studies varying in the extent to which this was emphasised. None of the studies has been retracted, and it is likely that poor quality research has had a substantial influence on clinical opinion in this area. I do not think that my sample is representative of the quality of medical literature as a whole. I have to admit that my decision to write the review was based on my perception of the poor calibre of many of the studies of growth in children with ADHD. However, I have no reason to believe that the level of poor quality research in my area of interest is unique. While retractions are important, the medical readership also has a responsibility to evaluate the scientific validity of published studies and, when necessary, correspond with the journals.

Alison Poulton

Statistics Public health 5 March 2007 Free

An outbreak of pulmonary tuberculosis in young Australians

Objective: To characterise a pulmonary tuberculosis (TB) cluster in the Hunter Area of New South Wales using a combination of traditional epidemiological methods and molecular typing.Design, setting and participants: Review of all notifications of TB in the Hunter Area between January 1994 and June 2005, with a detailed analysis of cases among people born in Australia or New Zealand.Main outcome measures: Comparison of genotypes of Mycobacterium tuberculosis isolates; extent of TB cluster.Results: Over the period studied, there were 72 TB notifications among people born in Australia or New Zealand. Genotypic testing was available for 20 of these cases, of which nine were confirmed to be part of a cluster. Two further cases for which genotyping was not available were epidemiologically linked to the cluster and regarded as probable cluster cases. Members of the cluster were relatively young (median age at diagnosis, 35 years; range, 21–57 years), and eight were women. Over the same period, there were 83 TB notifications among people born overseas, the majority being from Asia (47%) or central and eastern Europe (24%) (median age, 54 years; range, 9–63 years).Conclusion: Clinicians should maintain a high index of suspicion for pulmonary TB in a person presenting with a productive cough lasting more than 3 weeks, weight loss, haemoptysis, night sweats and chest pain, even if the person is not overseas-born or elderly. A comprehensive tuberculosis genotyping network at regional and national level in Australia could help identify clusters resulting from recent transmission.

Tony D Merritt MB BS, MPH · Vitali Sintchenko MB BS, FRCPA, PhD · Peter Jelfs BSc · Margaret Worthing RN · Brian Robinson RN, MMSc · David N Durrheim MB ChB, DrPH, FAFPHM · Gwendolyn L Gilbert MD, FRCPA, FRACP

Genetics Systematic review 5 March 2007 Free

Folic acid and risk of twinning: a systematic review of the recent literature, July 1994 to July 2006

Objective: To assess the evidence of an association between periconceptional folic acid (FA) supplementation or fortification of foods with FA and the risk of twinning, using the Food Standards Australia New Zealand (FSANZ) framework for assessing evidence when substantiating nutrition, health and related claims on foods.Data sources: The Cochrane Library Database, MEDLINE, MEDLINE in Process, EMBASE, PubMed National Library of Medicine, and CINAHL were searched to identify systematic reviews and primary intervention and observational studies published from 1 July 1994 to 7 July 2006.Study selection: One prospective and five retrospective cohort studies that assessed the rate of twinning in populations exposed to FA through supplementation, and six retrospective registry-based cohort studies examining twinning rates after fortification of foods with FA.Data extraction: Two reviewers appraised eligible studies and evaluated data independently.Data synthesis: The best maximal risk estimates of twinning after FA supplementation were an adjusted odds ratio (adjOR) of 1.26 (95% CI, 0.91–1.73) for preconceptional supplementation and dizygotic twinning and an adjOR of 1.02 (95% CI, 0.85–1.24) for overall twinning. Data from four FA fortification studies in the United States that allowed for calculation of an annual percentage increase showed a maximal annual increase in twinning rates of 4.6%.Conclusions: Overall, under the FSANZ framework, there is possible evidence for a relationship between periconceptional FA intake and increased twinning. To support this tentative relationship, more well designed, long-term follow-up studies are needed in places where fortification with FA has been introduced, focusing on dose–response and obtaining accurate data on infertility treatments.

Evelyne E Muggli MPH · Jane L Halliday PhD

Statistics Letters 5 February 2007 Free

Suicide mortality data need revision

To the Editor: In 2004, there were 580 cases of suicide in Queensland, and not 453, as reported by the Australian Bureau of Statistics (ABS) on 14 March 2006.1 These data alone reverse the declining trend for suicide mortality nationally in the most recent years. The Queensland Suicide Register, maintained by the Australian Institute for Suicide Research and Prevention (AISRAP), receives data directly from the Office of the State Coroner, and crosschecks them with other Queensland coroners, the John Tonge Centre (the Queensland Health Scientific Services mortuary), and the National Coroners Information System (NCIS). The ABS receives data from the state registries of births, deaths and marriages, and crosschecks them with the state coroners’ offices. The agreement between the two agencies has been decreasing in recent years, with AISRAP detecting 550 suicide cases in 2003 and 588 in 2002, compared with 466 and 537, respectively, detected by the ABS (Box). The ABS has acknowledged difficulties in getting reliable data for 2004 in a number of endnotes to its yearly report.1 Most of the problems were related to a very large backlog of cases still under investigation by coroners, a phenomenon that is reported as increasing in recent years. A confirmation of problems in official data comes from the NCIS, whose most recent report has evidenced, from 2000 on, declining percentages of completeness in mortality data in Queensland and elsewhere in Australia, with the most incomplete figures in 2004.2 It is important to note that cases that are under investigation and those that end with an open verdict would not enter official suicide mortality data, as these are never reconciled. Following the example of many European countries, it would be desirable to start a periodical publication (eg, every 3–5 years) to provide a more comprehensive picture of suicide mortality, including finalised investigations, reclassified (ex-accidental or ex-undetermined) causes of deaths, and deaths that occurred (especially in hospitals) with a delay from a self-injurious event. This would provide a more credible depiction of suicide mortality in the country, and permit better research.3 Meanwhile, efforts should be made to homogenise certification procedures (International classification of diseases, 10th revision terminology has yet to be extensively adopted) and streamline the bureaucratic procedures (we still suffer from a number of “lost in the system” data). In the registries of births, deaths and marriages, by law, the word “suicide” (or analogous term) does not appear. Frequently, the ABS, which collects data from the registries each month, has to reclassify the data obtained, and integrate the information received with further enquiries. Apart from being time-consuming, this routine does not provide foolproof results, and has potential for improvement. Some underreporting in suicide statistics is virtually ubiquitous,3,4 and has to be tolerated (eg, misclassification as accident, road accident, or disease-related, particularly in the elderly; cover-up because of stigma, sociocultural norms, or insurance reasons; or remoteness of location). However, federal and state governments in Australia are committed to suicide prevention plans that require credible baselines for evaluating their effects. All relevant parties need to work jointly on improving data quality. This is of crucial importance for scientists and policymakers, and for those personally affected by a suicide death. Number of suicides in Queensland according to the Australian Bureau of Statistics and the Queensland Suicide Register (QSR) QSR data were provided by the Office of the State Coroner, the National Coroners Information System and the John Tonge Centre. “Possible” suicides are not included. Data for 2005 are an estimate.

Diego De Leo

Ethics For debate 15 January 2007 Free

Waiver of individual patient consent in research: when do potential benefits to the community outweigh private rights?

Health services research is important to ensure continued best quality of care, but often uses data obtained without explicit consent for this purpose. Obtaining consent may be difficult for many reasons, but excluding individuals may introduce biases that alter the significance of studies. Approval by ethics committees of a waiver of the need for consent allowed our study to proceed and provide evidence that has led to the implementation of a population-based screening policy for the prospective detection of hereditary non-polyposis colorectal cancer. This screening policy has resulted in more cases being detected routinely with better management for affected patients and their at-risk families. A need for consent would have prohibited this study, and the development of a more efficient screening policy could have been delayed for several more years. Ethics committees can effectively manage the need to uphold basic ethical principles without unnecessarily impeding socially useful research. Committees need to be familiar with the guidelines approved under sections 95 and 95A of the Privacy Act 1988 (Cwlth) in addition to the National Health and Medical Research Council National statement on ethical conduct in research involving humans.

Nikolajs Zeps PhD · Barry J Iacopetta PhD · Lyn Schofield MPH · Jillian M George BHealthSci, RN · Jack Goldblatt MB ChB, MD, FRACP

Nutrition surveys or surveillance: one-night stands or a long-term commitment?

Many disparate groups in Australia now concur about the need for continuous food and nutrition monitoring Poor nutrition contributes to Australia’s current health problems in several ways. Heart disease and cancer, both strongly related to nutrition, remain the leading causes of death. At the same time, the prevalence of obesity and diabetes is alarmingly high, and deficiencies of vitamin D, iodine, and calcium are re-emerging. As a consequence, policymakers, food regulators and health professionals need up-to-date and specific information about what people are eating and how much they are eating. They need to know the health and nutritional status of the Australian population. They also need to know how supplies of food and food consumption patterns are changing over time, and what food products contain. In turn, consumer education policies and tools, such as population dietary guidelines and food selection guides, need to be built on a solid foundation of knowledge about the national nutrition profile to reduce the risk of serious nutrition-related diseases and conditions. Food safety regulators also need this information to estimate current exposure to bioactive compounds that may be of concern, such as food additives and contaminants, to inform food fortification policies, and to ensure that nutrition information on food labels is relevant to current consumption patterns. Yet, Australia is unusual among its peers for not having continuous nutrition intelligence. Health-related data about Australians are compiled biannually, but current information about food and nutrient consumption, and trends in these, is conspicuous by its absence.1 The United States, the United Kingdom, and many European nations have had ongoing, systematic programs for monitoring the diet and nutritional status of their populations for many years.2-4 These programs are not confined to large countries with big budgets. For example, in 2001, New Zealand embarked on a 10-year strategic plan for a coordinated national population survey program that includes nutrition surveys in adults and another in children every 10 years, with the next surveys of adults and of children due in 2007–08, and 2012, respectively.5 In contrast, Australia has conducted only three national surveys of diet in the past 50 years: a national dietary survey of adults in 1983, and of children in 1985, and the National Nutrition Survey in 1995, which included both adults and children.6-8 Each cross-sectional survey was conducted by a different agency, using different sampling and collection methods and food composition data. These differences limit our ability to describe trends in food and nutrient consumption.9 Several state and territory governments in Australia have established monitoring systems that survey health behaviours, including food habits.10 These systems provide important information for tracking change, but food production, retailing and consumption are not limited by state boundaries, and information about selected food habits is not a sufficient base on which to build nutrition and food regulatory policy. Those with commercial as well as health interests in nutrition surveillance now favour a new national effort — one that goes beyond the brief encounters of cross-sectional surveys — to provide continuous detailed information on trends in food and nutrient consumption, the food supply and the nutritional status of Australians. Continuous nutritional surveillance must form part of a comprehensive policy to combat nutritional disorders. Where such surveillance exists, such as in the US, the data have been used to evaluate dietary guidelines, revise food selection guides,11 develop and evaluate fortification programs, set “real-life” serving sizes for nutrition information panels on food labels, make decisions about specific food processing regulations, and model the impacts of bioterrorism threats from food contamination.2 The centrepiece of the US system is the continuing National Health and Nutrition Examination Survey (NHANES), which is supplemented by many other sources of data.12 International experience suggests that there are two important actions for Australia to take in developing a food and nutrition monitoring system: 1. Establish a small, affordable, but statistically robust ongoing nutrition survey program, with data collected from a sample each year and reported cumulatively over a number of years. This program should be based within a federal agency that has health information responsibilities, uses consistent methods, can document and maintain databases, and reports on a predictable and timely basis. 2. Create a small nutrition monitoring unit to compile, disseminate and promote the use of all appropriate information about the food and nutrition situation in Australia for various policy, program, and regulatory purposes. The Australian Government Department of Health and Ageing recently commissioned the preparation of a business case for a no-frills national nutrition surveillance system in Australia, and consulted widely with stakeholders on its importance and suitability.13 Many disparate groups in Australia — in food production, marketing, regulation, and consumer health — now concur about the need for continuous food and nutrition monitoring, as well as the imperative to find workable solutions to long-term funding needs. While a national cross-sectional nutrition survey of children is currently being planned, its value would be greater if it were the start of a continuing surveillance program. In this regard, the recent announcement by the Minister for Health and Ageing of $3 million initially for a survey of diet, physical activity, and the weight status of Australian children, and $1 million annually thereafter for the collection of similar data on all population groups in Australia, is welcome, especially if it evokes a matching response from other key data users, including the states and territories.14 This may be the politically propitious moment for a long-term commitment to a system of continuous monitoring of food and nutrition in Australia.

Karen L Webb PhD, MPH · Ingrid H Rutishauser MSc · Geoffrey C Marks PhD, MS, DipNutrDiet · Gregory Masters MSc · Stephen R Leeder PhD, FRACP

Statistics Systematic review 4 September 2006 Free

Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review

Objective: To determine whether the adoption of the CONSORT checklist is associated with improvement in the quality of reporting of randomised controlled trials (RCTs).Data sources: MEDLINE, EMBASE, Cochrane CENTRAL, and reference lists of included studies and of experts were searched to identify eligible studies published between 1996 and 2005.Study selection: Studies were eligible if they (a) compared CONSORT-adopting and non-adopting journals after the publication of CONSORT, (b) compared CONSORT adopters before and after publication of CONSORT, or (c) a combination of (a) and (b). Outcomes examined included reports for any of the 22 items on the CONSORT checklist or overall trial quality.Data synthesis: 1128 studies were retrieved, of which 248 were considered possibly relevant. Eight studies were included in the review. CONSORT adopters had significantly better reporting of the method of sequence generation (risk ratio [RR], 1.67; 95% CI, 1.19–2.33), allocation concealment (RR, 1.66; 95% CI, 1.37–2.00) and overall number of CONSORT items than non-adopters (standardised mean difference, 0.83; 95% CI, 0.46–1.19). CONSORT adoption had less effect on reporting of participant flow (RR, 1.14; 95% CI, 0.89–1.46) and blinding of participants (RR, 1.09; 95% CI, 0.84–1.43) or data analysts (RR, 5.44; 95% CI, 0.73–36.87). In studies examining CONSORT-adopting journals before and after the publication of CONSORT, description of the method of sequence generation (RR, 2.78; 95% CI, 1.78–4.33), participant flow (RR, 8.06; 95% CI, 4.10–15.83), and total CONSORT items (standardised mean difference, 3.67 items; 95% CI, 2.09–5.25) were improved after adoption of CONSORT by the journal.Conclusions: Journal adoption of CONSORT is associated with improved reporting of RCTs.

Amy C Plint MD · David Moher PhD · Andra Morrison BSc · Kenneth Schulz PhD, MBA · Douglas G Altman PhD · Catherine Hill MB BS, MSc · Isabelle Gaboury PhD(c)

Information science Research enterprise 7 August 2006 Free

Increased expenditure on Australian health and medical research and changes in numbers of publications determined using PubMed

Objective: To determine temporal trends in PubMed publications for Australian authors compared with changes in funding for health and medical research (HMR).Design: Retrospective observational study.Setting: Internet-based bibliometric study that collated Australian HMR expenditure from the Australian Institute of Health and Welfare and Australian (and other) research publications from PubMed.Main outcome measures: Australian expenditure on HMR and numbers of PubMed-cited publications from 1980 to 2004, with subgroup analyses for universities, clinical trials, and genetic and biotechnology research, and comparison with similar results from the United Kingdom and New Zealand.Results: From 1980–81 to 2003–04, Australian HMR expenditure increased from $66 million to $1503 million and total Australian PubMed publications increased from 844 to 13 836. From 1995–96 to 2003–04, Australian publications for university-derived research and for clinical trials increased at a fairly constant rate. Genetic and biotechnology publications increased about fivefold (49 to 277) between 1990–91 and 2003–04. Between 1990 and 2004, total publications increased from 1754 to 3288 for New Zealand and from 12 401 to 19 600 for the UK.Conclusions: There is an association between increased funding for HMR and increased publications, as determined using PubMed, in the past 10 years. Using PubMed may be a simple way to track output from HMR expenditure.

Kumara Mendis MB BS, MSc, MD · Rick McLean MD, FRACP

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