Project description:ObjectiveTo assess the fulfilment of authors' and editors' individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties.DesignCross-sectional analysis.Setting and participantsTop-ranked five journals as per 2017 Journal Citation Report impact factor of 26 medical, surgery and imaging specialties.InterventionsObservational analysis.Primary and secondary outcome measuresPercentage of journals requiring disclosure of authors' and editors' individual potential conflicts of interest (CoI). Journals that were listed as followers of the International Committee of Medical Journal Editors (ICMJE) Recommendations, members of the Committee on Publication Ethics (COPE) and linked to a third party (ie, college, professional association/society, public institution).ResultsAlthough 99% (129/130) of journals required author's CoI disclosure, only 12% (16/130) reported individual editors' potential CoIs. Forty-five per cent (58/130) of journals were followers of the ICMJE Recommendations, and 73% (95/130) were COPE members. Most (69%; 90/130) were linked to a college, professional society/association or public institution. Only one journal did not have policies on individual authors' and editors' CoI disclosure.ConclusionVery few high-impact medical journals disclosed their editorial teams' individual potential CoIs-conversely, almost all required disclosure of authors' individual CoIs. Journal followers of the ICMJE Recommendations should regularly disclose the editors' individual CoIs, as this is the only legitimate way to ask the same transparency of authors.
Project description:BACKGROUND:In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests. After a case of editorial COI in a prominent bioethics journal, there is concern that the same level of oversight regarding COIs in the biomedical sciences may not apply to the field of bioethics. In this study, we examined the availability and comprehensiveness of COI policies for authors, peer reviewers, and editors of bioethics journals. METHODS:After developing a codebook, we analyzed the content of online COI policies of 63 bioethics journals, along with policy information provided by journal editors that was not publicly available. RESULTS:Just over half of the bioethics journals had COI policies for authors (57%), and only 25% for peer reviewers and 19% for editors. There was significant variation among policies regarding definitions, the types of COIs described, the management mechanisms, and the consequences for noncompliance. Definitions and descriptions centered on financial COIs, followed by personal and professional relationships. Almost all COI policies required disclosure of interests for authors as the primary management mechanism. Very few journals outlined consequences for noncompliance with COI policies or provided additional resources. CONCLUSION:Compared to other studies of biomedical journals, a much lower percentage of bioethics journals have COI policies and these vary substantially in content. The bioethics publishing community needs to develop robust policies for authors, peer reviewers, and editors and these should be made publicly available to enhance academic and public trust in bioethics scholarship.
Project description:BackgroundThe primary aim of our study was to evaluate the effects of undisclosed financial conflicts of interest in Achilles tendon rupture repair-focused systematic reviews.MethodsFollowing a cross-sectional study design, we searched MEDLINE and Embase for Achilles tendon rupture repair systematic reviews. We performed screening and data extraction in a blind, triplicate fashion. Each systematic review was evaluated on the individual characteristics of the study, presence of undisclosed and disclosed conflicts of interest, favorability of results and conclusions, and the relationship between conflicts of interest and the favorability of results and conclusions.ResultsOur search produced 172 total systematic reviews pertaining to Achilles tendon rupture repair; of those, only 12 were included in our study. Undisclosed conflicts of interest were found in half (6/12) of the included reviews. However, no significant association was found between conflict of interest and the favorability of results and conclusions.ConclusionUndisclosed conflicts of interests were discovered in a large percentage of our sample. This lack of disclosure did not appear to increase the likelihood of the systematic review results or conclusions reporting favorability of the intervention being investigated.Level of evidenceLevel II.
Project description:BackgroundFew studies have investigated the relationship between industry funding/conflicts of interest and authors' positions in opinion pieces on drug safety. Harmful effects of varenicline, a treatment for smoking cessation, have been highly contested.ObjectiveTo examine the association between pharmaceutical industry funding/authors' financial conflicts of interest and position on varenicline in opinion articles, especially in relation to the minimization of harms; to assess whether opinion pieces on drug safety issues written by authors with conflicts of interest are more frequently cited in the news or social media.DesignCross-sectional analysis.ParticipantsEnglish language opinion pieces and narrative reviews about varenicline published between May 2006 and February 2019.Main measuresOdds ratios and 95% confidence intervals; the Mann-Whitney two-sample statistic was used to test for differences in Altmetric scores, a measure of media attention.Key resultsOf the 221 included articles, 30.3% (67) disclosed the funding source and 62.9% (139) disclosed authors' conflicts of interest. Authors of opinion pieces on varenicline who reported financial ties to the pharmaceutical industry (as a conflict of interest or funding source) were more likely to minimise the cardiovascular and psychiatric risk of varenicline compared to those without conflicts of interest or industry funding (OR: 4.00; 95% CI: 1.32 to 12.16 for cardiovascular risk; OR: 8.51; 95% CI: 3.79 to 19.11 for psychiatric risk). These associations persisted in sensitivity analyses. No statistically significant difference in Altmetric score was found between articles with (mean 15.83, median 3) and without (mean 11.90, median 1) conflicts of interest, indicating similar media attention (p-value=0.11).ConclusionsWe found that authors with financial ties to drug companies were more likely to publish opinion pieces that minimised harms of varenicline. These results raise questions about journals' editorial policies to accept reviews of treatments from authors with financial relationships with manufacturers.
Project description:BackgroundConflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs).ObjectivesTo examine rates of disclosure of COI, including financial interests in companies that manufacture drugs that are recommended in CPGs on glycemic control in type 2 diabetes mellitus, and to explore the relationship between recommendations for specific drugs in a guideline and author COI.MethodsWe identified a cohort of relevant guidelines from the National Guideline Clearinghouse (NGC) and abstracted COI disclosures from all guideline authors for this observational, cross-sectional study. We determined which hypoglycemic drugs were recommended in each guideline, and explored the relationship between specific disclosures and whether a drug was recommended.ResultsAmong 13 included guidelines, the percentage of authors with one or more financial disclosures varied from 0 to 94% (mean 44.2%), and was particularly high for two US-based guidelines (91% and 94%). Three guidelines disclosed no author financial COI. The percentage of authors with disclosures of financial interests in manufacturers of recommended drugs was also high (mean 30%). On average, 56% of manufacturers of patented drugs recommended in each guideline had one or more authors with a financial interest in their company. We did not find a significant relationship between financial interests and whether a drug was recommended in our sample; US-based guidelines were more likely to make recommendations for a specific drug compared to non-US based guidelines.DiscussionAuthors of this cohort of guidelines have financial interests directly related to the drugs that they are recommending. Although we did not find an association between author COI and drugs recommended in these guidelines and we cannot draw conclusions about the validity of the recommendations, the credibility of many of these guidelines is in doubt.
Project description:BackgroundPrevious studies have highlighted the potential influence that industry relationships may have on the outcomes of medical research.ObjectiveWe aimed to determine the prevalence of author conflicts of interest (COIs) in systematic reviews focusing on melanoma interventions, as well as to determine whether the presence of these COIs were associated with an increased likelihood of reporting favorable results and conclusions.MethodsThis cross-sectional study included systematic reviews with or without meta-analyses focusing on interventions for melanoma. We searched MEDLINE and Embase for eligible systematic reviews published between September 1, 2016, and June 2, 2020. COI disclosures were cross-referenced with information from the CMS (Centers for Medicare & Medicaid Services) Open Payments database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office, and previously published COI disclosure statements. Results were quantified using descriptive statistics, and relationships were evaluated by Fisher exact tests.ResultsOf the 23 systematic reviews included in our sample, 12 (52%) had at least one author with a COI. Of these 12 reviews, 7 (58%) reported narrative results favoring the treatment group and 9 (75%) reported conclusions favoring the treatment group. Of the 11 systematic reviews without a conflicted author, 4 (36%) reported results favoring the treatment group and 5 (45%) reported conclusions favoring the treatment group. We found no significant association between the presence of author COIs and the favorability of results (P=.53) or conclusions (P=.15).ConclusionsAuthor COIs did not appear to influence the outcomes of systematic reviews regarding melanoma interventions. Clinicians and other readers of dermatology literature should be cognizant of the influence that industry may have on the nature of reported outcomes, including those from systematic reviews and meta-analyses.
Project description:ImportanceIt is unclear how medical journals address authors' financial and non-financial conflict of interest (COI).ObjectiveTo assess the policies of clinical journals for disclosure of financial and non-financial COI.MethodsCross sectional study that included both review of public documents as well as a simulation of a manuscript submission for the National Library of Medicine's "core clinical journals". The study did not involve human subjects. Investigators who abstracted the data, reviewed "instructions for authors" on the journal website and, in order to reflect the actual implementation of the COI disclosure policy, simulated the submission of a manuscript. Two individuals working in duplicate and independently to abstract information using a standardized data abstraction form, resolved disagreements by discussion or with the help of a third person.ResultsAll but one of 117 core clinical journals had a COI policy. All journals required disclosure of financial COI pertaining to the authors and a minority (35%) asked for financial COI disclosure pertaining to the family members or authors' institution (29%). Over half required the disclosure of at least one form of non-financial COI (57%), out of which only two (3%) specifically referred to intellectual COI. Small minorities of journals (17% and 24% respectively) described a potential impact of disclosed COI and of non-disclosure of COI on the editorial process.ConclusionWhile financial COI disclosure was well defined by the majority of the journals, many did not have clear policies on disclosure of non-financial COI, disclosure of financial COI of family members and institutions of the authors, and effect of disclosed COI or non-disclosure of COI on editorial policies.
Project description:BackgroundIndustry and orthopaedic surgeons often partner to develop new technology, which can lead to orthopaedic surgeons having financial conflicts of interest (FCOI). It is essential these FCOI be conveyed clearly to patients. It is unclear, however, whether and to what degree patients understand the ramifications of physician FCOI.Questions/purposesWe evaluated (1) patients' concerns regarding their surgeon having FCOI or the presence of institutional FCOI, (2) the effect of surgeon FCOI on patients' willingness to have surgery, and (3) patients' understanding of FCOI.MethodsWe asked 101 patients (66% female) receiving total joint arthroplasty from the orthopaedic practices of two surgeons at an academic health center to complete a descriptive, correlational designed survey at their 6-week followup appointment. The data collected included patient demographics, knowledge of FCOI, and the influence of FCOI on patient attitudes toward surgery and their surgeon.ResultsA minority of patients (13%) reported discussing FCOI with prior physicians and only 55% agreed or strongly agreed a surgeon should disclose FCOI. Only 15% of patients believed such conflicts would make them less likely to have their surgeon operate on them. Level of education was weakly correlated (Spearman's rho = 0.29) with patient understanding of FCOI.ConclusionsOverall, patients had a poor understanding of FCOI. Both level of education and previous discussions of FCOI predicted better understanding. This study emphasizes communication of FCOI with patients needs to be enhanced.
Project description:Backgroundtransparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue.Methods and findingswe sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006.Conclusionspublication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.