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      The impact of mandatory conflict of interest disclosures on editors’ manuscript acceptance decisions: A cross‐sectional observational study

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          Abstract

          Objective

          Although current ethical standards mandate conflict of interest (COI) disclosure by authors of peer‐reviewed publications, it is unknown whether disclosure affects a manuscript's fate. Our objective was to identify associations between author COI disclosure and editorial decision to publish.

          Methods

          We performed a cross‐sectional observational study of editorial decisions for original research and brief research report manuscripts submitted to Annals of Emergency Medicine between June 2014 and January 2018 using data from the journal's editorial decision software and data from a prior study that characterized author COI for the same manuscripts. Outcomes of interest included final editor decision to publish (primary), initial editor decision, and number of revisions. We compared outcomes for manuscripts with COI versus those without and by type of COI (commercial/government/other).

          Results

          Out of 1312 manuscripts in the sample, 65.1% had no COI declarations, and 34.9% had one or more. Overall likelihood of editorial decision to publish was 13.5% (115/854) for articles without COI and 26.9% (123/458) for those with COI. Overall likelihood of editorial decision to publish was 19.8% (19/96) for articles with commercial COI only versus 33.3% (35/105) for those with government COI only.

          Conclusions

          Articles with author‐reported COI were more likely to be published than those without such a declaration. Additionally, results suggest that reports of government COI are associated with improved chance of publication. Authorities should consider relaxing COI requirements temporarily to allow investigators to perform larger scale, randomized controlled studies of the impact of mandated COI disclosure.

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          Most cited references5

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

          Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover 3 main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors, to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all 3 study designs and 4 are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available at http://www.annals.org and on the Web sites of PLoS Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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            A randomized study of how physicians interpret research funding disclosures.

            The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians' reactions to trials with a high, medium, or low level of methodologic rigor. We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had high, medium, or low methodologic rigor, and each report included one of three support disclosures: funding from a pharmaceutical company, NIH funding, or none. For both factors studied (rigor and funding), one of the three possible variations was randomly selected for inclusion in the abstracts. Follow-up questions assessed the physicians' impressions of the trials' rigor, their confidence in the results, and their willingness to prescribe the drugs. The 269 respondents (53.5% response rate) perceived the level of study rigor accurately. Physicians reported that they would be less willing to prescribe drugs tested in low-rigor trials than those tested in medium-rigor trials (odds ratio, 0.64; 95% confidence interval [CI], 0.46 to 0.89; P=0.008) and would be more willing to prescribe drugs tested in high-rigor trials than those tested in medium-rigor trials (odds ratio, 3.07; 95% CI, 2.18 to 4.32; P<0.001). Disclosure of industry funding, as compared with no disclosure of funding, led physicians to downgrade the rigor of a trial (odds ratio, 0.63; 95% CI, 0.46 to 0.87; P=0.006), their confidence in the results (odds ratio, 0.71; 95% CI, 0.51 to 0.98; P=0.04), and their willingness to prescribe the hypothetical drugs (odds ratio, 0.68; 95% CI, 0.49 to 0.94; P=0.02). Physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials (odds ratio, 0.52; 95% CI, 0.37 to 0.71; P<0.001). These effects were consistent across all levels of methodologic rigor. Physicians discriminate among trials of varying degrees of rigor, but industry sponsorship negatively influences their perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial's quality. These effects may influence the translation of clinical research into practice.
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              Failure to discount for conflict of interest when evaluating medical literature: a randomised trial of physicians.

              Physicians are regularly confronted with research that is funded or presented by industry. To assess whether physicians discount for conflicts of interest when weighing evidence for prescribing a new drug. Participants were presented with an abstract from a single clinical trial finding positive results for a fictitious new drug. Physicians were randomly assigned one version of a hypothetical scenario, which varied on conflict of interest: 'presenter conflict', 'researcher conflict' and 'no conflict'. 515 randomly selected Fellows in the American College of Obstetricians and Gynecologists' Collaborative Ambulatory Research Network; 253 surveys (49%) were returned. MAIN OBJECT MEASURES: The self-reported likelihood that physicians would prescribe the new drug as a first-line therapy. Physicians do not significantly discount for conflicts of interest in their self-reported likelihood of prescribing the new drug after reading the single abstract and scenario. However, when asked explicitly to compare conflict and no conflict, 69% report that they would discount for researcher conflict and 57% report that they would discount for presenter conflict. When asked to guess how favourable the results of this study were towards the new drug, compared with the other trials published so far, their perceptions were not significantly influenced by conflict of interest information. While physicians believe that they should discount the value of information from conflicted sources, they did not do so in the absence of a direct comparison between two studies. This brings into question the effectiveness of merely disclosing the funding sources of published studies.
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                Author and article information

                Contributors
                carl.berdahl@csmc.edu
                Journal
                J Am Coll Emerg Physicians Open
                J Am Coll Emerg Physicians Open
                10.1002/(ISSN)2688-1152
                EMP2
                Journal of the American College of Emergency Physicians Open
                John Wiley and Sons Inc. (Hoboken )
                2688-1152
                26 March 2022
                April 2022
                : 3
                : 2 ( doiID: 10.1002/emp2.v3.2 )
                : e12680
                Affiliations
                [ 1 ] Departments of Medicine and Emergency Medicine Cedars‐Sinai Medical Center Los Angeles California 90048 USA
                [ 2 ] Departments of Emergency Medicine and Medicine University of California, San Francisco San Francisco California USA
                [ 3 ] Department of Emergency Medicine University of California, San Francisco San Francisco California USA
                Author notes
                [*] [* ] Correspondence

                Carl Berdahl, MD, MS, Cedars‐Sinai Medical Center, Departments of Medicine and Emergency Medicine, 8700 Beverly Blvd, Los Angeles, CA 90048, USA.

                Email: carl.berdahl@ 123456csmc.edu

                Article
                EMP212680
                10.1002/emp2.12680
                8957374
                957228be-cf3a-4a17-a9eb-e9b15c66c894
                © 2022 The Authors. JACEP Open published by Wiley Periodicals LLC on behalf of American College of Emergency Physicians

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 23 January 2022
                : 02 December 2021
                : 27 January 2022
                Page count
                Figures: 2, Tables: 1, Pages: 5, Words: 3255
                Funding
                Funded by: Cedars‐Sinai Medical Center , doi 10.13039/100013015;
                Categories
                Brief Research Report
                How Scientific Journals Work
                Custom metadata
                2.0
                April 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.2 mode:remove_FC converted:26.03.2022

                academic publishing,conflict of interest,editorial policy,emergency medicine,peer review,research ethics

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