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      Disclosing conflicts of interest in German publications concerning health services research

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      1 , , 1 , 1
      BMC Health Services Research
      BioMed Central

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          Abstract

          Background

          The influence of the pharmaceutical industry and other stakeholders on medical science has been increasingly criticised. When dealing with conflicts of interest in scientific publications it is important to ensure the best possible transparency. The objective of this work is to examine the disclosure practice of financial and non-financial conflicts of interest in German language publications concerning health services research for the first time.

          Methods

          We performed a systematic literature search in the PubMed data base using the MeSH term "health services research". The review was conducted on July 10, 2006, setting the limits "dates: published in the last 2 years" and "languages: German" (only articles with abstracts). 124 articles in 31 magazines were found. In the magazines the instructions for authors were examined as to whether a statement on conflicts of interest is expected – and if, in which form. Regarding the articles in the journals which require a statement, we examined whether the statement is explicitly published. The results are descriptively represented.

          Results

          13 magazines (42%) do not require any statement on conflicts of interest, whereas 18 journals (58%) expect a statement. Two of these 18 magazines refer explicitly to the uniform requirements of the International Committee of the Medical Journal Editors (ICMJE); the remaining 16 magazines give differently accentuated instructions on how to disclose conflicts of interest, whereby the focus is primarily on financial issues. A statement on conflicts of interest is explicitly published in 11 of the 71 articles (15%) which are found in the magazines that require a statement with the submission of a manuscript. Related to the total number of included articles, this means that the reader explicitly receives information on potential conflicts of interest in 9% of the cases (11 of 124 articles). Statements of others that are involved in the publication process (reviewers, editors) are not available in any of the articles examined.

          Conclusion

          A better sensitization for possible conflicts of interest in German publications concerning health services research is necessary. We suggest tightening the criteria for disclosure in the instructions for authors in the scientific journals. Among other things the equivalent consideration of financial and non-financial conflicts of interest as well as the obligatory publication of the statements should be part of good practice.

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          Most cited references16

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          Pharmaceutical industry sponsorship and research outcome and quality: systematic review.

          To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
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            Scope and impact of financial conflicts of interest in biomedical research: a systematic review.

            Despite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed. To review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research. Studies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts. All English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria. One investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest. Approximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals. Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.
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              Bias in published cost effectiveness studies: systematic review.

              To investigate if published studies tend to report favourable cost effectiveness ratios (below 20,000 dollars, 50,000 dollars, and 100,000 dollars per quality adjusted life year (QALY) gained) and evaluate study characteristics associated with this phenomenon. Systematic review. Studies reviewed 494 English language studies measuring health effects in QALYs published up to December 2001 identified using Medline, HealthSTAR, CancerLit, Current Content, and EconLit databases. Incremental cost effectiveness ratios measured in dollars set to the year of publication. Approximately half the reported incremental cost effectiveness ratios (712 of 1433) were below 20,000 dollars/QALY. Studies funded by industry were more likely to report cost effectiveness ratios below 20,000 dollars/QALY (adjusted odds ratio 2.1, 95% confidence interval 1.3 to 3.3), 50,000 dollars/QALY (3.2, 1.8 to 5.7), and 100,000 dollars/QALY (3.3, 1.6 to 6.8). Studies of higher methodological quality (adjusted odds ratio 0.58, 0.37 to 0.91) and those conducted in Europe (0.59, 0.33 to 1.1) and the United States (0.44, 0.26 to 0.76) rather than elsewhere were less likely to report ratios below 20,000 dollars/QALY. Most published analyses report favourable incremental cost effectiveness ratios. Studies funded by industry were more likely to report ratios below the three thresholds. Studies of higher methodological quality and those conducted in Europe and the US rather than elsewhere were less likely to report ratios below 20,000 dollars/QALY.
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                Author and article information

                Journal
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                1472-6963
                2007
                1 June 2007
                : 7
                : 78
                Affiliations
                [1 ]Department of Epidemiology, Social Medicine and Health System Research, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625 Hannover, Germany
                Article
                1472-6963-7-78
                10.1186/1472-6963-7-78
                1905913
                17543111
                bc06571c-6b3f-4711-bef3-9db11d05acce
                Copyright © 2007 Schneider et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 7 March 2007
                : 1 June 2007
                Categories
                Research Article

                Health & Social care
                Health & Social care

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