A common standard for conflict of interest disclosure in addiction journals

This paper presents a common standard for conflict of interest disclosure. The common standard was drafted by the authors, following consultation with a multi-disciplinary group of journal editors, publishers, bioethicists and other academics. It is presented here for the benefit of authors, editorial managers, journal editors and peer reviewers to stimulate discussion and to provide guidance to authors in reporting real, apparent and potential conflicts of interest. It is particularly relevant to addiction specialty journals because of the potential conflicts of interest associated with funding from the alcohol, tobacco, pharmaceutical and gambling industries. Following an appropriate period of vetting the common standard within the scientific community, it is recommended that journal editors adopt journal policies and reporting procedures that are consistent across journals.     

Clear principles are needed for integrity in gambling research

Commercial gambling is expanding rapidly across the globe. However, the field of gambling research has not kept pace with this expansion, and continues to focus on prevalence studies and individuated treatment regimes, with little attention to the political, economic or technological underpinnings of commercial gambling. The implications of this lack of sophistication in the research agenda are that society is ill‐equipped to understand the nature and underlying causes of gambling harms, and how these might best be avoided, minimized or ameliorated. Around the world, various levels of government benefit from gambling revenue, with consequences for the independent regulation of gambling. Further, there is considerable industry influence on the research agenda, often involving similar techniques to those employed previously by the tobacco and alcohol industries to engage researchers. This influence is compounded by a failure of many gambling researchers and journals to adopt traditional academic safeguards, such as the disclosure of conflicts of interest, and by many arguing for a ‘partnership model’ with industry to advance the research agenda. This paper identifies five basic principles to restore reasonable standards of integrity in gambling studies: (1) research should not be funded by the proceeds of gambling; (2) research priorities should not be influenced by the beneficiaries of gambling; (3) conferences and other research fora should not be influenced by industry; (4) funding sources should be disclosed in journals and at conferences; and (5) meaningful access to gambling products and environments must be part of licensing. We also propose a range of actions to promote greater transparency and independence in the gambling research field.     

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research

Background: Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. Method: We conducted a survey of HREC chairpersons in New South Wales. Results: HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. Conclusion: These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.     

Promoting transparent and accurate reporting of research studies in rheumatology: Endorsement of reporting guidelines in rheumatology journals

Objectives

To adequately translate research into practice, research results should be reported in a way that is useful to practicing clinicians and policymakers. Based on evidence from systematic reviews, the implementation of reporting guidelines, such as CONSORT for randomized controlled trials, may improve the quality of research reporting. We assessed the endorsement of reporting guidelines in rheumatology journals.

Methods

We analyzed guidelines for authors of all (n = 28) journals indexed in the “Rheumatology” Subject Category of the Journal Citation Reports published in 2012. Journal websites were reviewed for information relevant to reporting guidelines.

Results

Out of 28 indexed journals, only about a third (n = 10) endorsed 1 or more reporting guidelines, most commonly CONSORT. General editorial policies, such as those from the International Committee of Medical Journal editors (ICMJE), were endorsed by 19 journals (all 10 journals with and 9 out of 18 without reporting guidelines). Two rheumatology journals introduced specific reporting guidelines about economic studies and genetic association studies.

Conclusions

The endorsement of reporting guidelines is low in rheumatology journals. To continue to serve their research community, rheumatology journals should provide the platform for the discussion on most relevant reporting guidelines and adopt them as a group, especially those specific for rheumatology research. Coordinated action of journals and other stakeholders in rheumatology research in the promotion of accurate and transparent reporting of health research studies would be an important part of knowledge translation into practice and well-being of rheumatology patients.     

Changes in study design,gender issues,and other characteristics of clinical research published in three major medical journals from 1971 to 1991

OBJECTIVE: To examine trends in study design and other characteristics of original research published inJAMA, Lancet, and theNew England Journal of Medicine (NEJM) between 1971 and 1991. DESIGN: A retrospective cross-sectional study of original clinical research published inJAMA, Lancet, andNEJM during 1971, 1981, and 1991. MEASUREMENTS: Four hundred forty-four articles were independently reviewed by at least two investigators and classified according to study design and other preselected study characteristics. Changes over time were analyzed by chi-square tests for categorical variables and analysis of variance for continuous variables. MAIN RESULTS: Clinical results doubled, from 17% of all articles in 1971 to 35% in 1991 (p<0.004), while case series decreased from 30% to 4% (p<0.0001). Of 118 clinical trials, randomized controlled trials increased from 31% to 76% (p<0.003) and nonrandomized controlled trials decreased from 42% to 8% (p<0.002). Multicenter studies increased from 10% to 39% (p<0.0001) and the prevalence of health services research increased from none in 1971 to 12% in 1991 (p<0.001). The proportion of the studies explicitly excluding women from the subject population decreased from 11% in 1971 to 3% in 1991 (p<0.03). In 1991 7% of the studies were composed entirely of men subjects, while only 0.7% of the studies were specific to men’s health. Twelve percent of the studies in 1991 were specific to women’s health. Between 1971 and 1991 there was no change in the prevalence of women first authors or studies addressing women’s or minorities’ health issues. CONCLUSIONS: Several important changes in clinical research studies published inJAMA, Lancet, andNEJM have taken place between 1971 and 1991. Clinical trials have increased in frequency, largely replacing studies containing ten or fewer subjects. Health services research has increased in prevalence, reflecting growing interest in studies addressing the delivery of health care. Our data support the hypothesis that exclusion of women from clinical research studies is an important contributor to the paucity of data concerning women’s health. Presented at the annual meeting of the Midwest Regional Society of General Internal Medicine, September 11, 1993, Chicago, Illinois, and at the annual national meeting of the Society of General Internal Medicine, April 27–29, 1994, Washington, DC.