Research

Objective: To estimate the short-term benefits of a reduction in smoking on acute myocardial infarction (AMI) and stroke hospitalisations and costs.Design and setting: Epidemiological study which applied functions describing reductions over time in risk of AMI and stroke in people quitting smoking to hospitalisation rates and costs for Australia.Main outcome measures: The numbers of AMI and stroke hospitalisations in 35–64-year-olds and the associated costs that could have been avoided over a 7-year period from 2001–02 if smoking prevalence had decreased by 1% in the first year (Scenario 1) or by 1% per annum for 5 consecutive years (Scenario 2).Results: Under Scenario 1, almost 1000 hospitalisations for AMI and about 350 hospitalisations for stroke would have been avoided over 7 years, saving about $20.4 million in health care costs. Under Scenario 2, over 3000 AMI hospitalisations and over 1000 stroke hospitalisations would be avoided, and health care costs could be reduced by $61.6 million (2.75% of costs for AMI and stroke over the period).Conclusions: This study provides further support for the proposition that modest and achievable reductions in smoking rates can substantially improve health outcomes and reduce health care costs, even in the short term.

Susan F Hurley MPharm, MS(Biostatistics), PhD

Objectives: To assess young people’s ability to recognise clinically defined depression and psychosis, the types of help they thought appropriate for these problems, their knowledge of appropriate treatments, and their perceptions regarding prognosis.Design: A cross-sectional telephone survey using structured interviews. Vignettes of a person with either depression or psychosis were presented, followed by questions related to recognition of the disorder, best forms of treatment and the prognosis.Participants: A randomly selected sample of 1207 young people aged 12–25 years.Setting: Melbourne, Victoria, and surrounding regional and rural areas.Outcome measures: Responses to a mental health literacy questionnaire.Results: Almost half the respondents were able to identify depression correctly, whereas only a quarter identified psychosis correctly. Counsellors and family or friends were the most commonly cited forms of best help, with family or friends preferred by the younger age group for depression. General practitioners were considered more helpful for depression, and psychiatrists and psychologists more helpful for psychosis. Most respondents considered counselling and psychotherapy to be helpful. However, more than half the respondents expressed negative or equivocal views regarding the helpfulness of recommended pharmacological treatments.Conclusions: The limitations we identified in youth mental health literacy may contribute to the low rates of treatment and the long duration of untreated illness reported in other studies. There is a need for initiatives to enhance mental health literacy among young people, and those close to them, if benefits of early treatment are to be realised.

Annemarie Wright BAppSc(OT), MMedSc(HProm) · Meredith G Harris MPH, MPASR, BA(Hons) · Anthony F Jorm DSc · Sue M Cotton BBSc(Hons), GradDipAppSci (Statistics), MAppSci (Statistics) · Susy M Harrigan BA, GradDipAppSci, MSc · Patrick D McGorry MD, PhD, FRANZCP · John H Wiggers BA(Hons), PhD · Rosalind E Hurworth PhD, MEd, PostGradDipSoc

Objective: To establish the rate of and reasons for cancellations of surgery on the scheduled day in an Australian hospital.Design: Prospective survey.Setting: Major metropolitan tertiary hospital, 13 May to 15 November 2002.Main outcome measures: Proportion of operations cancelled on the day of surgery, obtained each day from the operating theatre list and a separate list of additions and cancellations compiled on the day; reasons for cancellations from the cancellation list, extended or confirmed, as necessary, by questioning of bookings and ward staff, or members of the surgical team; estimated and actual duration of each operation and patient information from hospital clinical records.Results: 7913 theatre sessions were scheduled by 133 surgeons in the study period; 941 of these (11.9%) were cancelled on the day, including 724 of 5472 (13.2%) elective procedures on working weekdays. Main reasons for cancellation were: no theatre time due to over-run of previous surgery (18.7%); no postoperative bed (18.1%); cancelled by patient (17.5%); and change in patient clinical status (17.1%). Procedural reasons (including patient not ready, no surgeon, list error, administrative cause, and communication failure) totalled 21.0%. Ear, nose and throat surgery experienced the most cancellations (19.6%), followed by cardiothoracic surgery (15.8%).Conclusions: There were five major reasons of similar magnitude for on-the-day surgery cancellations. We estimated that 60% of cancellations of elective procedures were potentially avoidable. Change of one factor leading to cancellation (eg, provision of more postoperative beds) is not likely to lead to improvement unless the other major factors are also tackled.

William N Schofield MA, DipEdPsych · George L Rubin FAFPHM, FACR · Michael Piza BA(Hons), MPH · Ying Yin Lai MScApplStat · Doungkamol Sindhusake BA, MPH, PhD · Michael R Fearnside MS, FRACS · Peter L Klineberg FANZCA

Objectives: To characterise research relationships between medical specialists and the pharmaceutical industry in Australia.Design and setting: Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003.Main outcome measures: Details of medical specialists’ involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes.Results: Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for “internal” documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity.Conclusions: These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.

David A Henry MB ChB, MRCP, FRCP · Suzanne R Hill PhD, GradDipEpi, FAFPHM · Evan Doran BA, PhD · David A Newby BPharm, PhD · Kim M Henderson BNurs, GradDip(HealthSocSci) · Jane Maguire BA, BNurs(Hon) · Barrie J Stokes BSc, MMath · Ian H Kerridge MPhil, FRCPA, FRACP · Paul M McNeill MA, LLB, PhD · Richard O Day MD, FRACP · Graham J Macdonald MD, FRACP, FRCP

Objective: To review acute spinal cord injuries (ASCIs) in all Australian codes of football (rugby union [RU], rugby league [RL], Australian Rules football [ARF] and soccer) for 1997–2002 and to compare data with those of a 1986–1996 survey.Design: Retrospective review of hospital records, and structured interviews with injured players.Participants and setting: Patients admitted to any of the six Australian spinal cord injury units with a documented football-related ASCI over the period 1997–2002.Outcome measures: Average annual incidence of ASCIs per 100 000 players in the different codes, final Frankel grading of injuries, and wheelchair status.Results: Fifty-two footballers (45 adult men and seven schoolboys) suffered ASCIs between 1997 and 2002. The average annual incidence of ASCIs per 100 000 players was 3.2 for RU, 1.5 for RL, 0.5 for ARF and 0.2 for soccer. While there has been little change in incidence since the 1986–1996 survey, there has been a trend towards less severe injuries in RU and RL, but not in ARF. There have been no scrum injuries in RL since 1996, when the scrum stopped being contested. Seven injuries occurred in RU scrums, six at the moment of engagement of the opposing teams. The incidence of 2-on-1 and “gang” tackles (involving multiple tacklers) in RL is disturbing. Overall, 39% of injured players became permanently wheelchair-dependent.Conclusions: There continues to be good reason to revise the laws of scrum engagement in RU. The laws relating to multiple tacklers in RL should be examined. The insurance cover for injured players is grossly inadequate. The longstanding need for a registry of spinal cord injuries for all football codes regrettably remains unmet.

David J Carmody MB BS · Thomas K F Taylor DPhil(Oxon), FRACS · David A Parker FRACS · Myles R J Coolican FRACS · Robert G Cumming MB BS, MPH, PhD

Objective: To assess the prevalence and causes of vision loss in Australia and to project these data into the future.Design: Synthesis of data from two cross-sectional population-based cohort studies — the Melbourne Visual Impairment Project and the Blue Mountains Eye Study — and extrapolation to the entire Australian population.Setting and participants: 8376 community and 533 nursing home residents recruited between 1992 and 1996 in urban and rural Victoria and New South Wales.Main outcome measures: Age-standardised prevalence of low vision (visual acuity < 6/12) and blindness (visual acuity < 6/60) (both measured in the best eye, with spectacles if usually worn for distance vision), and their causes for the Australian population for 2000 to 2024, projected from Australian Bureau of Statistics population data.Results: In 2004, 480 300 Australians were estimated to have low vision, including 50 600 with blindness. The most common causes of low vision were undercorrected refractive error (62%), cataract (14%) and age-related macular degeneration (10%). The latter was responsible for almost half of all cases of blindness. The numbers of people with low vision and blindness are projected to almost double by 2024.Conclusions: Vision loss in Australia is a much bigger problem than is usually recognised; 76% of low vision is caused by uncorrected refractive error or cataract, both readily treatable. However, the prevention and treatment of macular degeneration poses a major challenge.

Hugh R Taylor AC, MD · Jill E Keeffe PhD · Hien T V Vu PhD · Jie Jin Wang MMed, PhD · Elena Rochtchina MApplStat · Paul Mitchell MD, PhD · M Lynne Pezzullo BEc

Objective: To compare rates of percutaneous coronary interventions (PCI) and bypass surgery after acute myocardial infarction (AMI) in Indigenous and non-Indigenous patients.Design: Cohort study of public-sector patients who were followed up for 1 year using administrative hospital data.Participants and setting: We followed up 14 683 public-sector patients admitted to Queensland hospitals for AMI between 1998 and 2002. Of these, 558 (3.8%) identified as Indigenous.Outcome measures: Rates of PCI and bypass surgery, adjusted for differences between the Indigenous and non-Indigenous cohorts according to age, sex, socioeconomic status, remote residence, hospital characteristics, and comorbidities.Results: The adjusted rate for PCI during the index admission was significantly lower by 39% (rate ratio [RR], 0.61; 95% CI, 0.38–0.98) among Indigenous versus non-Indigenous patients with AMI; the adjusted rate for subsequent PCI was significantly lower by 28% (RR, 0.72; 95% CI, 0.54–0.96). Adjusted rates for bypass surgery were similar in the two cohorts. For any coronary procedure (ie, PCI or bypass surgery), the adjusted rate was significantly lower by 22% (RR, 0.78; 95% CI, 0.64–0.94) among Indigenous patients with AMI. Diabetes, chronic renal failure, pneumonia, and chronic rheumatic fever were at least twice as common among Indigenous patients with AMI as in the rest of the cohort, and chronic bronchitis and emphysema and heart failure were at least 60% more common. If a patient had at least one comorbidity, then their probability of having a coronary procedure was reduced by 40%.Conclusions: There are likely to be several reasons for the lower rates of coronary procedures among Indigenous patients, but their high rates of comorbidities and the association of comorbidities with lower procedure rates was an important finding. As investment in primary care can reduce the prevalence and severity of comorbidities, we suggest that adequate primary health care is a prerequisite for effective specialist care.

Michael D Coory PhD, FAFPHM · Warren F Walsh FRACP, FACC

Objectives: To evaluate the impact of a community-based, collaborative, shared antenatal care intervention (the Mums and Babies program) for Indigenous women in Townsville.Design and participants: Prospective cohort study of women attending Townsville Aboriginal and Islander Health Service (TAIHS) for shared antenatal care with a singleton Indigenous birth between 1 January 2000 and 31 December 2003 (456 women; the MB group), compared with a historical control group of 84 women who attended TAIHS for antenatal care before the intervention between 1 January 1998 and 30 June1999, and a contemporary control group of 540 women who had a singleton birth at Townsville Hospital between 1 January 2000 and 30 June 2003, but did not attend TAIHS for antenatal care.Intervention: Integration of previously autonomous service providers delivering shared antenatal care from TAIHS.Main outcome measures: Patterns of antenatal visits, proportion of women undertaking key antenatal screening, and perinatal outcomes.Results: The number of Indigenous women who entered the MB program and gave birth at Townsville Hospital rose from 23.8% in 2000 to 61.2% in 2003. The number of antenatal care visits per pregnancy increased from three (interquartile [IQ] range, 2–6) in the historical control group to seven (IQ range, 4–10) in the MB group (P < 0.001). 88% of women in the MB group had at least one ultrasound. About 90% of all women attending for antenatal care were screened for sexually transmitted infections. In the MB group, there was a significant reduction in preterm births compared with the contemporary control group (8.7% v 14.3%, P < 0.01). There was no significant reduction in the prevalence of low birthweight births or perinatal mortality.Conclusion: A community-based collaborative approach to shared antenatal care services increased access to antenatal care and was associated with fewer preterm births among Indigenous women in Townsville. The model may be adaptable in other urban centres with multiple antenatal care providers and significant numbers of Indigenous people across Australia.

Kathryn S Panaretto MB BS, MPH · Heather M Lee HealthWorkerCert3 · Melvina R Mitchell EN · Sarah L Larkins MPH, FRACGP · Vivian Manessis FRACGP · Petra G Buettner PhD · David Watson FRANZCOG

Objective: To describe how a novel program of diabetic retinopathy screening was conceived, refined and sustained in a remote region over 10 years, and to evaluate its activities and outcomes.Design: Program description; analysis of regional screening database; audit of electronic client registers of Aboriginal community controlled health services (ACCHSs).Setting and participants: 1318 Aboriginal and 271 non-Aboriginal individuals who underwent retinal screening in the 5 years to September 2004 in the Kimberley region of north-west Australia; 11 758 regular local Aboriginal clients of Kimberley ACCHSs as at January 2005.Main outcome measures: Characteristics of clients and camera operators, prevalence of retinopathy, photograph quality, screening intervals and coverage.Results: Among Aboriginal clients, 21% had diabetic retinopathy: 19% with non-proliferative retinopathy, 1.2% with proliferative retinopathy, and 2.8% with maculopathy. Corresponding figures for non-Aboriginal clients were 11%, 11%, 0 and 0.4%, respectively. Photograph quality was generally high, and better for non-Aboriginal clients, younger Aboriginal clients and from 2002 (when mydriatic use became universal). Quality was not related to operator qualifications, certification or experience. Of 718 regular Aboriginal clients with diabetes on local ACCHS databases, 48% had a record of retinal screening within the previous 18 months, and 65% within the previous 30 months.Conclusions: Screening for diabetic retinopathy performed locally by Aboriginal health workers and nurses with fundus cameras can be successfully sustained with regional support. Formal certification appears unnecessary. Data sharing across services, client recall and point-of-care prompts generated by electronic information systems, together with policies making primary care providers responsible for care coordination, support appropriate timely screening.

Richard B Murray MB BS, MPH · Sue M Metcalf MPH · Philomena M Lewis AHW · Jacqueline K Mein MB BS, FACShM, MAE · Ian L McAllister FRANZCO

Objectives: To assess the accuracy of point-of-care (POC) measurements of capillary blood glucose and glycosylated haemoglobin (HbA1c) levels in a remote Aboriginal community with high diabetes prevalence.Design: Cross-sectional study comparing POC capillary glucose and HbA1c results with those from corresponding venous samples measured in a reference laboratory.Participants and setting: 152 residents aged 11–76 years (representing 76% of population aged over 11 years) had POC glucose measurement in November 2003; 88 with POC glucose level ≥ 5.0 mmol/L, or self-reported diabetes, had POC HbA1c and laboratory glucose and HbA1c measurements.Main outcome measures: POC fasting capillary levels of glucose (HemoCue Glucose 201 analyser, Medipac Scientific, Sydney) and HbA1c (DCA 2000+ analyser, Bayer Australia, Melbourne); correlation and mean difference between capillary POC and venous blood laboratory measurements of glucose and HbA1c.Results: Mean and median POC capillary glucose levels were 7.99 mmol/L and 6.25 mmol/L, respectively, while mean and median laboratory venous plasma glucose concentrations were 7.63 mmol/L and 5.35 mmol/L. Values for POC capillary HbA1c and laboratory HbA1c were identical: mean, 7.06%; and median, 6.0%. The correlation coefficient r for POC and laboratory results was 0.98 for glucose and 0.99 for HbA1c. The mean difference in results was 0.36 mmol/L for glucose (95% CI, 0.13–0.62; limits of agreement [LOA], − 2.07 to 2.79 mmol/L; P = 0.007) and < 0.01% for HbA1c (95% CI, − 0.07% to 0.07%; LOA, − 0.66% to 0.66%; P = 0.95), respectively.Conclusions: POC capillary HbA1c testing, in particular, offers an accurate, practical, community-friendly way of monitoring diabetes in rural and remote clinical settings. POC capillary glucose results should be confirmed by a laboratory test of venous plasma if the results are likely to significantly influence clinical decisions.

David D Martin MB BS, PhD · Timothy W Jones DCH, FRACP · Elizabeth A Davis FRACP · Mark D S Shephard MSc, MAACB · Hayley Freeman RN · Graeme P Maguire MPHTM, FRACP, PhD · Max K Bulsara MSc

Objective: To evaluate the role of zinc and vitamin A supplementation in the recovery of Indigenous children hospitalised for acute diarrhoea.Design: A randomised controlled 2 by 2 factorial trial of supplementation with zinc and vitamin A.Setting and participants: Aboriginal children (aged < 11 years) hospitalised for acute diarrhoea at Alice Springs Hospital, Northern Territory, April 2001–July 2002.Main outcome measures: Duration of diarrhoeal illness; re-admission for diarrhoeal illness within 120 days.Results: Our study involved 392 Aboriginal children with 436 episodes of diarrhoea. Supplementation with zinc, vitamin A, or combined zinc and vitamin A had no significant effect on duration of diarrhoea or rate of re-admission compared with placebo. Median diarrhoea duration after starting supplementation was 3.0 days for the vitamin A and zinc supplemented and placebo groups (P values 0.25 and 0.69, respectively). The number of re-admissions did not differ significantly between those receiving vitamin A or zinc and the relevant placebo groups (relative risk [95% CI], 1.2 [0.7–2.1] and 1.3 [0.8–2.1], respectively).Conclusion: Vitamin A and zinc supplementation may not be indicated for in-hospital management of acute diarrhoeal disease in Aboriginal children living in remote areas. This finding may not apply to children with malnutrition, for whom other studies suggest a benefit. Larger trials incorporating more comprehensive data on the vitamin A and zinc status as well as nutritional status of study populations might help to explain the different results in different populations.

Patricia C Valery MD, MPH, PhD · David M Purdie BSc(Hons), PhD · Paul J Torzillo MB BS, FRACP, FFICM · Peter A Stewart MB BS, FRCPA · Naomi C Boyce B Nursing · Anne B Chang MPHTM, FRACP, PhD · Andrew V White MB BS, FRACP · Gavin R Wheaton MB BS, FRACP · John Wakerman MB BS, MPH

Aim: To estimate national rates of induced abortion in Australia from 1985 to 2003, using Medicare claim statistics for private patients and hospital morbidity statistics for public patients.Design and setting: Estimates were based on Australian and South Australian data collections relating to abortions. SA hospital morbidity statistics were compared with SA statutory notifications of abortions to estimate the accuracy of these collections. Medicare statistics on abortion procedures performed on private patients in South Australia were then compared with hospital morbidity statistics for private patients. National statistics on abortion derived from Medicare and hospital morbidity statistics were adjusted for inaccuracies found in these sources.Main outcome measures: Numbers of induced abortions in Australia for each year from 1985 to 2003; abortion rates per 1000 women aged 15–44 years.Results: Abortion numbers based on Medicare claims by private patients overestimated by 18.7% the number of abortions derived from statutory notifications in South Australia during the period 1988–89 to 1999–00. Hospital morbidity data using principal diagnosis codes relating to medical abortion overestimated statutory notifications by 2.3% (mainly because of readmissions). National statistics were adjusted for these overestimations and for the estimated 14.1% of private patients who would not have submitted Medicare claims (based on surveys of private-clinic patients in New South Wales and Victoria). The estimated Australian abortion rate increased from 17.9 per 1000 women aged 15–44 in 1985 to a peak of 21.9/1000 in 1995, then declined to 19.7/1000 in 2003 (estimated number of abortions, 84 460).Conclusion: There are no data currently available for deriving accurate numbers of induced abortions in Australia. Suggestions are made for collection of national statistics.

Annabelle Chan MB BS, FAFPHM · Leonie C Sage RN, RM

Objective: To evaluate the frequency and management of anaemia in Australian adults with solid and haematological malignancies.Design: 6-month observational, prospective, multicentre study.Participants: 694 patients recruited from outpatient oncology clinics in 24 hospitals in five Australian states between 9 April 2001 and 31 July 2001.Main outcome measures: Frequency of anaemia (haemoglobin [Hb] level < 120 g/L) at enrolment and over ensuing 6 months, by tumour type, disease status and cancer treatment; anaemia treatment and “trigger” Hb level for this treatment.Results: Participants had median age 60 years, and 61% were women. Prevalence of anaemia at enrolment was 35% (199/562), with 78% of these 199 having mild anaemia (Hb, 100–119 g/L). Frequency of anaemia (either present at enrolment or developing during the study) was 57% overall (323/566), and varied with tumour type, from 49% (lymphoma/myeloma) to 85% (urogenital cancer). Patients who received radiotherapy either in combination or concomitant with chemotherapy were more likely to have anaemia (73%) than those receiving chemotherapy alone (58%) (P = 0.004). Of all chemotherapy patients not anaemic at enrolment, 23% developed anaemia by the second monthly follow-up. Independent predictors for anaemia in chemotherapy patients were low baseline Hb level (odds ratio [OR], 5.4; 95% CI, 2.7–10.9) and use of platinum chemotherapeutic agents (OR, 4.8; 95% CI, 2.1–11.4) (P < 0.001). Anaemia was treated in 41% of patients with anaemia at enrolment — by transfusion (36%), iron (5%) and erythropoietic agents (2%). Frequency of anaemia treatment varied between tumour types, from 19% (breast cancer) to 60% (leukaemia). The mean “trigger Hb” for initiating transfusion was 95 g/L.Conclusions: Anaemia is prevalent among Australian patients with cancer managed in hospital oncology units. Its management varies between tumour types. Many patients do not receive treatment for their anaemia.

Tara Seshadri MB BS · H Miles Prince FRACP, MD · David R Bell FRACP · Paul B Coughlin FRACP, PhD · Philip P B James DM, FRACP · Gary E Richardson FRACP · Boris Chern FRACP, FAChPM · Peter Briggs FRACP · John Norman FRACP · Ian N Olver MD, PhD, FRACP · Chris Karapetis FRACP, MMedSc · John Stewart FRACP

Objective: To report the outcome of gene therapy in an infant with X-linked severe combined immunodeficiency (SCID-X1), which typically causes a lack of T and natural killer (NK) cells.Design and setting: Ex-vivo culture and gene transfer procedures were performed at The Children’s Hospital at Westmead, Sydney, NSW, in March 2002. Follow-up to March 2005 (36 months) is available.Patient: A 9-month-old male infant with confirmed SCID-X1 (including complete absence of T cells) with an NK+ phenotype (a less common variant of SCID-X1), and no HLA-identical sibling donor available for conventional bone marrow transplantation.Procedure: CD34+ haemopoietic progenitor cells were isolated from harvested bone marrow and cultured with cytokines to stimulate cellular replication. Cells were then genetically modified by exposure to a retrovirus vector encoding human γc (the common γ chain of several interleukin receptors; mutations affecting the γc gene cause SCID-X1). Gene-modified cells (equivalent to 1.3 × 106 CD34+/γc+ cells/kg) were returned to the infant via a central line.Results: T cells were observed in peripheral blood 75 days after treatment, and levels increased rapidly to 0.46 × 109 CD3+ cells/L at 5 months. Within 2 weeks of the appearance of T cells, there was a distinct clinical improvement, with early weight gain and clearance of rotavirus from the gut. However, T-cell levels did not reach the reference range, and immune reconstitution remained incomplete. The infant failed to thrive and developed weakness, hypertonia and hyperreflexia in the legs, possibly the result of immune dysregulation. He went on to receive a bone marrow transplant from a matched unrelated donor 26 months after gene therapy.Conclusions: This is the first occasion that gene therapy has been used to treat a genetic disease in Australia. Only partial immunological reconstitution was achieved, most likely because of the relatively low dose of gene-corrected CD34+ cells re-infused, although viral infection during the early phase of T-cell reconstitution and the infant’s NK+ phenotype may also have exerted an effect.

Samantha L Ginn BSc(Hons), PhD · Julie A Curtin PhD, FRACP · Christine M Smyth MSc, PhD · Margot Latham BSc · Sharon C Cunningham BSc(Hons), PhD · Maolin Zheng BSc(Hons), MSc · Linda Hobson BPharm(Hons) · Peter B Rowe MD, FRACP · Ian E Alexander PhD, FRACP · Belinda Kramer BSc(Hons), MSc · Melanie Wong PhD, FRACP · Alyson Kakakios FRACP · Geoffrey B McCowage FRACP · Debbie Watson BSc(Hons) · Stephen I Alexander FRACP · Alain Fischer MD, PhD · Marina Cavazzana-Calvo PhD · Salima Hacein-Bey-Abina PhD

Australia has so far been spared serious mishaps in health research, but rising pressures on researchers, deemed to have contributed to two deaths of research participants in the United States, clearly also exist in Australia. Health research investment in our institutions is large and represents an often overlooked area of risk by boards of management. Research governance (the framework through which institutions are ultimately accountable for the scientific quality, ethical acceptability and safety of research conducted in the institutions) has not received sufficient attention. An adequate governance framework requires institutions to have policies and procedures in place to meet national ethical, legal and research practice standards. We suggest that many institutions presently do not have such frameworks in place and inappropriately rely too heavily on human research ethics committees. To ensure ongoing adequate protection of research participants, we recommend some simple improvements for research governance and suggest ways by which institutions can demonstrate adherence to agreed national standards.

Michael K Walsh MB BS, MPA, FRACMA · John J McNeil MB BS, PhD, FRACP · Kerry J Breen MB BS, MD, FRACP

Objective: To measure the pattern of admissions of young adults to a children’s hospital.Design and setting: Ten-year audit (1992–2001) of admissions of young adults aged 18 years and over to the Royal Children’s Hospital (RCH), Melbourne, with a detailed chart review of the 2001 cohort to assess disease complexity and transition planning.Outcome measures: Number of admissions, disease complexity, transition planning.Results: There was a significant increase in the number of young adults admitted over 10 years, from 308 in 1992–1993 to 659 in 2000–2001. The greatest increase was in admissions to surgical units. There was significant variation in admission practices between units over time. Many young adults required multidisciplinary care: 57% had more than three medical/surgical units involved in their care, and 34% had two or more allied health units involved. Fifty-one per cent of surgical inpatients and 28% of medical inpatients had no documented plan for transition to adult care. Only 30% of medical and 17% of surgical inpatients in 2001 had been transferred to adult services by 2002.Conclusions: Both disease complexity and failure of transition planning appear to have contributed to the increased admission of young adults to the RCH. While greater support of transition planning is needed, there are also concerns about the lack of appropriate services within the adult sector for young adults with complex, multidisciplinary healthcare needs.

Pei-Yoong Lam MB BS, FRACP · Bronwyn B Fitzgerald MB BS · Susan M Sawyer MB BS, MD, FRACP

Objective: To assess the degree to which men considered it appropriate for general practitioners to order prostate-specific antigen (PSA) testing if the testing was either “disclosed” or “undisclosed” to the patient.Design: Telephone-administered survey conducted in June to October 2000.Participants: 514 men aged 50–70 years, identified by random selection of households from the Sydney Electronic White Pages phone directory.Methods: We developed two hypothetical scenarios. Each scenario described a GP ordering a PSA test for a male patient at the same time as other pathology tests were ordered. In Scenario 1, the GP’s intention to order a PSA test was disclosed to the patient (“disclosed”). In Scenario 2, the GP did not tell the patient a PSA test was being ordered (“undisclosed”). For each scenario, men reported the degree to which they perceived screening to be “appropriate”. We also recorded demographic characteristics, health status and health locus of control, and administered a 14-question knowledge test about prostate cancer and PSA screening.Results: Over 90% of men stated that “disclosed” PSA screening was either “appropriate” or “very appropriate”. Significantly fewer (44.9%) rated “undisclosed” screening as appropriate/very appropriate (P < 0.001). While the skewed distribution of responses to Scenario 1 precluded multivariate analysis to determine predictors, men rejecting “undisclosed” PSA screening (Scenario 2) were more likely to be younger (adjusted odds ratio [AOR], 0.97; 95% CI, 0.94–1.00; P = 0.03); to have better knowledge of the issues (AOR, 1.01; 95% CI, 1.00–1.03; P = 0.02); and to be single (AOR, 0.62; 95% CI, 0.41–0.94; P = 0.02).Conclusions: Many men consider that inclusion of PSA screening within a battery of pathology tests without disclosure to the patient is unacceptable. Educating men about the pros and cons of screening may alter their support of opportunistic screening and thus enhance community expectations of “informed participation”.

Melina Gattellari BSc(Hons), PhD · Jeanette E Ward MB BS, PhD, FAFPHM

Objective: To identify variation in the rates of use of key evidence-based therapies and in clinical outcomes among patients hospitalised with acute coronary syndromes (ACS).Design: Retrospective analysis of data on care processes and clinical outcomes of representative patient samples recorded by the Queensland Health Cardiac Collaborative registry.Setting: 18 public hospitals (3 tertiary, 15 non-tertiary) in Queensland, August 2001 to December 2003.Study population: 2156 patients who died or were discharged after troponin-positive ACS.Main outcome measures: Comparison of proportions of highly eligible patients receiving indicated care and in-hospital mortality between subgroups categorised by age, sex, comorbidities (diabetes, renal failure, chronic obstructive pulmonary disease and mental disorder), type of admitting hospital (tertiary or non-tertiary), and cardiologist involvement (transfer or non-transfer to cardiology unit).Results: Patients aged ≥ 65 years were less likely than younger patients to receive heparin (79% v 87%), β-blockers (79% v 87%), lipid-lowering agents (78% v 87%), coronary angiography (51% v 66%), and referral to cardiac rehabilitation (17% v 33%). Patients with diabetes were less likely than others to receive coronary angiography (50% v 63%), while those with moderate to severe renal failure were less likely to receive thrombolysis (52% v 84%), heparin (71% v 83%), β-blockers (69% v 84%), lipid-lowering agents (61% v 84%), in-hospital cardiac counselling (46% v 64%) and referral to cardiac rehabilitation (9% v 25%). Patients admitted to tertiary hospitals were more likely than those admitted to non-tertiary hospitals to receive coronary angiography (85% v 55%) and referral to cardiac rehabilitation (36% v 21%). Risk-adjusted mortality was highest in patients with moderate to severe renal failure (15% v 3%) and older patients (6% v 2%).Conclusions: Variations exist in the provision of indicated care to patients with ACS according to age, diabetic status, renal function and type of admitting hospital. Excess mortality in elderly patients and in those with advanced renal disease may be partially attributable to failure to use key therapies.

Ian A Scott FRACP, MHA, MEd · Mark A Jones BSc(Hons) · Andy B Duke · Irene C Darwin BSpThy, GradCertManagement · Kathy H Harvey GradCertManagement

Objectives: To determine population-based rates and outcomes of hypertensive disorders in pregnancy.Design: Cross-sectional study using linked population databases.Setting and participants: All women, and their babies, discharged from hospital following birth in New South Wales, between 1 January 2000 and 31 December 2002.Main outcome measures: Rates of hypertensive disorders in pregnancy, maternal and infant morbidity and mortality, and level of hospital care for the birth admission.Results: 250 173 women and their 255 931 infants were included in the study. Overall, 24 517 women (9.8%) had a hypertensive disorder in pregnancy, including 1411 (0.6%) with chronic hypertension, 10 379 (4.2%) with pre-eclampsia, 731 (0.3%) with chronic hypertension with superimposed pre-eclampsia, and 10 864 (4.3%) with gestational hypertension. Women with, and infants exposed to, hypertension were more likely to suffer death or major morbidity than those without hypertension. Infants of mothers with hypertension were more likely to be to born preterm and small for gestational age. Just over half the women with major morbidity or mortality delivered in hospitals with a high level of medical care. In contrast, most infants with major morbidity or mortality were delivered in hospitals with neonatal intensive care units.Conclusions: Hypertension is a common complication of pregnancy, and adverse outcomes are increased among hypertensive women and their babies. Clinicians appear to be better at identifying and seeking an appropriate level of care for pregnancies where the infant is at risk of a poor outcome than when the mother is at risk. More specific antenatal indicators of poor maternal outcome would help guide the referral of hypertensive women to higher levels of care.

Christine L Roberts MB BS, DrPH · Jane B Ford BA(Hons), PhD · David J Henderson-Smart FRACP, PhD · Charles S Algert BSc, MPH · Jonathan M Morris FRANZCOG, PhD

Objective: To examine trends in adverse drug reactions (ADRs) in people aged 60 years or over causing admission to or an extended stay in Western Australian hospitals between 1981 and 2002.Design and setting: Secondary data analysis of case series.Patients: 43 380 patients admitted to WA public and private hospitals with an (International Classification of Diseases) ICD external cause code for an ADR, identified by the population-based WA Hospital Morbidity Data System.Main outcome measures: Age-specific, age-standardised and drug-specific rates of ADR-related hospital stays.Results: The age-standardised rate of ADR-related hospital stays increased from 2.5 per 1000 person-years (py) in 1981 to 12.9 per 1000 py in 2002. The largest increases occurred in those aged 80 + years (tenfold in men and sevenfold in women). The most common drug group involved was cardiovascular agents (17.5%), while anticoagulants (7.5%), cytotoxics (7.4%) and antirheumatics (6.8%) were the more specific drug classes most often implicated. ADRs from the last three classes of drugs were still rising at the end of the study, whereas ADRs from corticosteroids and antihypertensives peaked in 1996 and from opioids in 2000.Conclusions: Increases in hospital admissions or extended lengths of stay due to ADRs in WA have continued despite programs to promote rational and safer use of medicines. The sharp increase in ADRs from anticoagulants warrants attention to revised clinical guidelines.

Christel L Burgess BHlthSc(Hons) · C D’Arcy J Holman MB BS, MPH, PhD · Anthony G Satti BEd

Objective: To evaluate the effect on depressive symptoms in cardiac patients of patient-specific advice to general practitioners regarding management of comorbid depression.Design and setting: A randomised controlled trial in four general hospitals in Adelaide, South Australia.Participants: Patients (n = 669) admitted to cardiology units for a range of cardiovascular conditions who were screened and assessed as being depressed according to the Center for Epidemiological Studies Depression Scale (CES-D).Intervention: Inpatient psychiatric review, followed by telephone case conferencing between specialist hospital staff and GPs to provide patient-specific information about the patient’s depression and its management, educational material, and ongoing clinical support.Main outcome measures: Level of depression severity at 12 months post-hospitalisation.Results: On the basis of intention to treat, intervention patients had lower rates of moderate to severe depression (CES-D ≥ 27) after 12 months (25% v 35%, relative risk, 0.72; 95% CI, 0.54–0.96, number needed to treat for benefit, 11). The intervention was most effective in preventing progression from mild depression to moderate to severe depression. The multidisciplinary telephone case conferencing was difficult to implement and, in a post hoc analysis, brief phone advice from a psychiatrist was found to be effective.Conclusions: Screening hospitalised cardiac patients for depression and providing targeted advice to their GPs reduces depression severity 12 months after hospitalisation.

Geoff Schrader PhD, FRANZCP · Frida Cheok PhD · Ann-Louise Hordacre PhD · Julie Marker GDPH · Victoria Wade FRANCGP, MPsych

Objective: To investigate whether Indigenous Australians with cancer have more advanced disease at diagnosis than other Australians, and whether late diagnosis explains lower Indigenous cancer survival rates.Design: Retrospective cohort study.Setting and participants: Indigenous and non-Indigenous people diagnosed with cancers of the colon and rectum, lung, breast or cervix and non-Hodgkin lymphoma in the Northern Territory of Australia in 1991–2000.Main outcome measures: SEER summary stage of cancer at diagnosis (local, regional or distant spread), cause-specific cancer survival rates and relative risk of cancer death.Results: Diagnosis with advanced disease (regional or distant spread) was more common for Indigenous people (70%; 95% CI, 62%–78%) than for non-Indigenous people (51%; 95% CI, 53%–59%) with cancers of the colon and rectum, breast, cervix and non-Hodgkin lymphoma, but for lung cancer the opposite was found (Indigenous, 56% [95% CI, 46%–65%] v non-Indigenous, 69% [95% CI, 64%–75%]). Stage-adjusted survival rates were lower for Indigenous people for each cancer site. With few exceptions, the relative risk of cancer death was higher for Indigenous people for each category of stage at diagnosis for each cancer site.Conclusions: Health services apparently could, and should, be performing better for Indigenous people with cancer in the Northern Territory, and probably elsewhere in Australia. This study has demonstrated that data from cancer registers, enhanced with data on stage at diagnosis, can be used to monitor health service performance for Indigenous Australians in the Northern Territory; similar data is available in other States, and could be used to monitor health service performance for Indigenous people throughout Australia.

John R Condon MPH, FAFPHM · Tony Barnes MSc · Bruce K Armstrong DPhil · Sid Selva-Nayagam FRACP · J Mark Elwood MD

Objectives: To determine and compare the prevalence of Helicobacter pylori in an urban and a remote rural Western Australian Indigenous community.Design: Cross-sectional study of Helicobacter pylori status determined by urea breath tests between mid-January 2003 and the end of June 2004.Participants: 520 self-selected fasting participants, comprising 270 members of the Martu community at Jigalong, Punmu and Parnngurr in the East Pilbara region (129 men, 141 women; age range, 2–90 years) and 250 people from the Perth Indigenous community (96 men, 154 women; age range, 3–75 years.Results: The overall prevalence of H. pylori was 76%, but the prevalence in the remote rural community was 91%, compared with 60% in the urban community. The odds of having H. pylori were six times greater for rural than for urban participants (odds ratio [OR], 6.34; 95% CI, 3.89–10.33). Further, the overall odds of H. pylori infection in males (rural and urban combined) were greater than for females (OR, 1.61; 95% CI, 1.02–2.54). In both communities, the prevalence of infection remained relatively constant after the age of 10.Conclusions: The prevalence of H. pylori in the two Indigenous communities was two to three times higher than that in the non-Indigenous Australian population and higher than that shown in previous studies in Indigenous Australians.

Helen M Windsor PhD · Susan D Morrow BA · Barry J Marshall FRACP · Emmanuel A Abioye-Kuteyi MB BS · Jacqueline M Leber RN · Max K Bulsara MSc

Objective: To evaluate the effect of a behaviour modification program, taught to parents in a single visit to a trained nurse, in improving sleep performance in newborn infants.Design: Randomised controlled trial.Setting and participants: 268 families with normal newborn infants in the community, recruited between October 1996 and March 1997 from birth notices published in a South Australian daily newspaper.Intervention: A 45-minute consultation with a nurse 2–3 weeks after the birth, including a tutorial discussion on normal sleep patterns in newborn infants, supported by retained written material and, for infants with weight gain < 30 g daily, referral to their usual postnatal care provider.Main outcome measures: Hours of daytime sleep (0600–1800), night sleep (1800–0600) and total sleep per 24 h; and number of daily records with total sleep ≥ 15 h per 24 h, assessed by 7-day sleep diary at ages 6 and 12 weeks.Results: 268 families returned at least one sleep diary (137/171 intervention, 131/175 control), recording 3273 days. Two intervention infants were referred for low weight gain. Total sleep time was 15 h or more per 24 h on 62% of recorded days in the intervention group, compared with 36% in the control group (P < 0.001). At 6 weeks of age, intervention infants slept a mean 1.3 h per day more than control infants (95% CI, 0.95–1.65), comprising a mean 0.5 h more night sleep (95% CI, 0.32–0.69) and 0.8 h more daytime sleep (95% CI, 0.56–1.07). At 12 weeks, intervention infants slept a mean 1.2 h per day more (95% CI, 0.94–2.14), comprising 0.64 h more night sleep (95% CI, 0.19–0.89) and 0.58 h more daytime sleep (95% CI, 0.39–1.03). There was no significant difference in crying time between the groups.Conclusions: A single consultation supported by written material in the first 3 weeks of a child’s life improves sleep performance at 6 weeks of age. This improvement is maintained at 3 months.

Brian G Symon MD · John E Marley MD · A James Martin MD · Emily R Norman MB BS

Objective: To study the impact of various risk factors on survival time in a cohort of elderly Australians.Design, setting and participants: A longitudinal, prospective cohort study conducted in Dubbo, NSW. Participants were men and women aged 60 years or over living in the community, first assessed in 1988–1989 and followed for 15 years.Main outcome measures: Mortality rates; risk factors; survival times.Results: There were 668 deaths in 1233 men (54%) and 625 deaths in 1572 women (40%). Coronary heart disease was the major cause of death, rates being higher in men than women until age group 80+ years; stroke death rates were similar in both sexes; cancer and respiratory death rates were higher in men than women across all ages. In a proportional hazards model, the independent predictors of mortality were cigarette smoking, diabetes, very high blood pressure (BP), impaired peak expiratory flow (PEF), physical disability, and zero intake of alcohol. Over 15 years, the average reductions in survival time associated with various risk factors, in men and women respectively, were smoking, 22 and 15 months; diabetes, 18 and 18 months; very high BP, 16 and 9 months; impaired PEF, 14 and 17 months; physical disability, 16 and 12 months; zero alcohol intake, 9 and 5 months. Combinations of selected risk factors were associated with a multiplier effect.Conclusion: The reduction in survival time in elderly citizens demonstrated in the presence of smoking, diabetes and hypertension highlights a potential benefit to healthy ageing to be gained from prevention and intervention.

Leon A Simons MD, FRACP · Judith Simons MACS · John McCallum DPhil · Yechiel Friedlander PhD