http://nova.newcastle.edu.au/vital/access/services/Feed ${session.getAttribute("locale")} 5 http://nova.newcastle.edu.au/vital/access/manager/Repository/uon:213 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. 2011-02-08T23:20:09.820Z ]]> http://nova.newcastle.edu.au/vital/access/manager/Repository/uon:1120 Background: This study investigated the 'gift-relationship' between pharmaceutical companies and doctors. Methods: The study was based on a survey questionnaire of 823 medical specialists from across Australia. The aim of this study was to investigate gifts offered to medical specialists in Australia by pharmaceutical companies, financial support actively sought by medical specialists for activities other than research and to consider what is ethically appropriate. Results: A high percentage of specialists received offers of food (96%), items for the office (94%), personal gifts (51%) and journals or textbooks (50%). Most specialists were invited to product launches, symposia or educational events (75–84%) and 52% received offers of travel to conferences. A high proportion of offers were accepted (66–79%) except invitations to product launches (49%), sponsored symposia (53%) and offers of travel that included partners (27%). Fifteen per cent of specialists requested financial support from pharmaceutical companies for activities and items, including conferences, travel, educational activities, salaries and donations to specific funds. The study outlined guidelines on gifts from pharmaceutical companies and differing standards applying to gifts and grants for travel. We found that, although most gifts and requests for support complied with professional and pharmaceutical industry guidelines, some – including personal gifts, tickets to sporting events, entertainment and travel expenses for specialists' partners – did not. Conclusion: To ensure that physicians' judgements are free from real or perceived influence from industry and to maintain public trust, we support a shift towards more conservative standards on gifts and support for travel evident in recent guidelines. 2010-04-27T06:07:15.564Z ]]> http://nova.newcastle.edu.au/vital/access/manager/Repository/uon:412 Background: The identification of factors that contribute to noncompliance with trial drug initiation where virtually complete compliance might be expected, may help identify patients whose management is least likely to comply with clinical guidelines and study protocols. Methods: Examination of cross-sectional and longitudinal data arising from the Second Australian National Blood Pressure Study. Prevalence rate ratios (RR) and 95% confidence intervals (CI) estimated from log-binomial models were used to assess associations between subject characteristics and whether the randomized drug was prescribed at trial randomization. The study population consisted of 6083 hypertensive Australians aged 65 to 84 years. Results: After adjusting for each variable in a multivariate model the following were significant predictors of failure to prescribe RR (95% CI): not previously prescribed antihypertensive drugs 2.89 (2.52-3.32); lower systolic blood pressure (BP) 1.51 (1.59-1.43) or diastolic BP 1.18 (1.22-1.13); younger age 80 to 84 v 65 to 79 years 0.75 (0.59-0.95); total cholesterol >= 6.6 v <= 5.0 mmol/L 1.27 (1.06-1.53); and not ever having had a raised cholesterol 1.20 (1.04-1.40). There was no difference in cardiovascular disease end points and death in those who were and were not initiated on drug therapy at randomization. Conclusions: Failure to initiate antihypertensive therapy for patients at the randomization visit was associated with lower BP measurements, previous drug therapy, younger age, and a historic or current raised cholesterol, but not with overt cardiovascular disease or other risk factors. There was no difference in cardiovascular disease end points and death in those who were and were not initiated on drug therapy at randomization. 2010-04-27T05:45:44.638Z ]]> http://nova.newcastle.edu.au/vital/access/manager/Repository/uon:389 Background: There is extensive and varied interaction between the pharmaceutical industry and the medical profession. Most empirical research concerns contact between individual physicians and industry, and reflects North American experience. We sought to clarify the extent and nature of relationships between the pharmaceutical industry and Australian medical organizations. Methods: We administered questionnaires to 63 medical organizations concerned with clinical practice, continuing medical education or professional accreditation, or the political representation of medical professionals. Results: Survey instruments were received from 29 organi-zations, giving a response rate of 46%. Seventeen of these organizations (59%) had received support from one or more pharmaceutical company in the past financial year. Support was predominantly for annual conferences, with some support for continuing medical education, research, travel and library purchases. The majority of organizations had an academic journal or newsletter, and 10 (34%) accepted revenue from pharmaceutical advertising. Twenty organizations (72%) had policies or guidelines covering their relationship with industry. Few organizations indicated that they would be unable to continue their activities without pharmaceutical industry support. Conclusion: These data indicate a high level of inter-action between the pharmaceutical industry and medical organizations in Australia. While most organizations have policies for guiding their relationship with industry, it is unclear whether these are effective in preventing conflicts of interest and maintaining public trust. 2010-04-27T05:45:03.362Z ]]> http://nova.newcastle.edu.au/vital/access/manager/Repository/uon:509 The characterization of blood pressure in treatment trials assessing the benefits of blood pressure lowering regimens is a critical factor for the appropriate interpretation of study results. With numerous operators involved in the measurement of blood pressure in many thousands of patients being screened for entry into clinical trials, it is essential that operators follow pre-defined measurement protocols involving multiple measurements and standardized techniques. Blood pressure measurement protocols have been developed by international societies and emphasize the importance of appropriate choice of cuff size, identification of Korotkoff sounds, and digit preference. Training of operators and auditing of blood pressure measurement may assist in reducing the operator-related errors in measurement. This paper describes the quality control activities adopted for the screening stage of the 2nd Australian National Blood Pressure Study (ANBP2). ANBP2 is cardiovascular outcome trial of the treatment of hypertension in the elderly that was conducted entirely in general practices in Australia. A total of 54 288 subjects were screened; 3688 previously untreated subjects were identified as having blood pressure >140/90 mmHg at the initial screening visit, 898 (24%) were not eligible for study entry after two further visits due to the elevated reading not being sustained. For both systolic and diastolic blood pressure recording, observed digit preference fell within 7 percentage points of the expected frequency. Protocol adherence, in terms of the required minimum blood pressure difference between the last two successive recordings, was 99.8%. These data suggest that adherence to blood pressure recording protocols and elimination of digit preferences can be achieved through appropriate training programs and quality control activities in large multi-centre community-based trials in general practice. Repeated blood pressure measurement prior to initial diagnosis and study entry is essential to appropriately characterize hypertension in these elderly patients. 2010-04-27T05:38:27.800Z ]]>