Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study.
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ABSTRACT: Objectives
To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents.Design
Cross sectional study.Data sources
Cochrane Database of Systematic Reviews.Selection criteria
Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials.Results
Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed.Conclusions
Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews.
SUBMITTER: Roseman M
PROVIDER: S-EPMC3423635 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo (1) investigate the extent to which recently published meta-analyses report trial funding, author-industry financial ties and author-industry employment from included randomised controlled trials (RCTs), comparing Cochrane and non-Cochrane meta-analyses; (2) examine characteristics of meta-analyses independently associated with reporting funding sources of included RCTs; and (3) compare reporting among recently published Cochrane meta-analyses to Cochrane reviews published in 2010.DesignReview of consecutive sample of recently published meta-analyses.Data sourcesMEDLINE database via PubMed searched on 19 October 2018.Eligibility criteria for selecting articlesWe selected the 250 most recent meta-analyses listed in PubMed that included a documented search of at least one database, statistically combined results from ≥2 RCTs and evaluated the effects of a drug or class of drugs.Results90 of 107 (84%) Cochrane meta-analyses reported funding sources for some or all included trials compared with 21 of 143 (15%) non-Cochrane meta-analyses, a difference of 69% (95% CI 59% to 77%). Percent reporting was also higher for Cochrane meta-analyses compared with non-Cochrane meta-analyses for trial author-industry financial ties (44% versus 1%; 95% CI for difference 33% to 52%) and employment (17% versus 1%; 95% CI for difference 9% to 24%). In multivariable analysis, compared with Cochrane meta-analyses, the odds ratio (OR) for reporting trial funding was ≤0.11 for all other journal category and impact factor combinations. Compared with Cochrane reviews from 2010, reporting of funding sources of included RCTs among recently published Cochrane meta-analyses improved by 54% (95% CI 42% to 63%), and reporting of trial author-industry financial ties and employment improved by 37% (95% CI 26% to 47%) and 10% (95% CI 2% to 19%).ConclusionsReporting of trial funding sources, trial author-industry financial ties and trial author-industry employment in Cochrane meta-analyses has improved since 2010 and is higher than in non-Cochrane meta-analyses.
| S-EPMC7229983 | biostudies-literature
Project description:BackgroundDiscrepancies in outcome reporting (DOR) between protocol and published studies include inclusions of new outcomes, omission of prespecified outcomes, upgrade and downgrade of secondary and primary outcomes, and changes in definitions of prespecified outcomes. DOR can result in outcome reporting bias (ORB) when changes in outcomes occur after knowledge of results. This has potential to overestimate treatment effects and underestimate harms. This can also occur at the level of systematic reviews when changes in outcomes occur after knowledge of results of included studies. The prevalence of DOR and ORB in systematic reviews is unknown in systematic reviews published post-2007.ObjectiveTo estimate the prevalence of DOR and risk of ORB in all Cochrane reviews between the years 2007 and 2014.MethodsA stratified random sampling approach was applied to collect a representative sample of Cochrane systematic reviews from each Cochrane review group. DOR was assessed by matching outcomes in each systematic review with their respective protocol. When DOR occurred, reviews were further assessed if there was a risk of ORB (unclear, low or high risk). We classified DOR as a high risk for ORB if the discrepancy occurred after knowledge of results in the systematic review.Results150 of 350 (43%) review and protocol pairings contained DOR. When reviews were further scrutinised, 23% (35 of 150) of reviews with DOR contained a high risk of ORB, with changes being made after knowledge of results from individual trials.ConclusionsIn our study, we identified just under a half of Cochrane reviews with at least one DOR. Of these, a fifth were at high risk of ORB. The presence of DOR and ORB in Cochrane reviews is of great concern; however, a solution is relatively simple. Authors are encouraged to be transparent where outcomes change and to describe the legitimacy of changing outcomes in order to prevent suspicion of bias.
| S-EPMC7076244 | biostudies-literature
Project description:Guideline recommendations may be biased due to conflicts of interest (COI) of panel members and sponsorship of the guideline. Potential impact of COI, and their management, should be transparently reported. We analysed 110 guidelines published in ten anaesthesia journals from 2007 to June 2018. We report on the number (%) that 1) published COI disclosures; 2) in a distinct paragraph; 3) described and explained the COI of panel members, and 4) of the Chairperson; 5) reported and described the presence or absence and potential impact of a sponsor of the guideline on the recommendations; and 6) reported how COI were managed. COI were published in 70/110 (64%) guidelines; in a distinct paragraph in 25/70 (36%). Panel members reported having no COI in 27/70 (39%) guidelines, disclosed COI without describing their potential impact in 41/70 (59%), and described their potential impact in 2/70 (3%). Chairpersons were identified in 50 guidelines, 32 of which published COI disclosures; 16/32 (50%) reported having no COI, 14/32 (44%) disclosed COI without describing their potential impact, 1/32 (3%) described their impact and 1/32 (3%) made no statement regarding COI. Presence or absence of a sponsor of the guideline was reported in 40 guidelines; 12/40 (30%) declared none, 24/40 (60%) reported sponsoring without explanation of the potential impact, and 4/40 (10%) described the potential influence of the sponsor on the guideline recommendations. Seventy-five guidelines reported COI of panel members and/or sponsorship of the guideline but only seven described how the COI had been managed. Disclosures of COI of panel members and of sponsors of guidelines have increased over the 12 year period, but remain insufficiently described and their potential influence on the guidelines' recommendations is poorly documented.
| S-EPMC6392260 | biostudies-literature
Project description:BackgroundSystematic reviews are increasingly used to inform health policy-making. The conflicts of interest (COI) of the authors of systematic reviews may bias their results and influence their conclusions. This may in turn lead to misguided public policies and systems level decisions. In order to mitigate the adverse impact of COI, scientific journals require authors to disclose their COIs. The objective of this study was to assess the frequency and different types of COI that authors of systematic reviews on health policy and systems research (HSPR) report.MethodsWe conducted a cross sectional survey. We searched the Health Systems Evidence (HSE) database of McMaster Health Forum for systematic reviews published in 2015. We extracted information regarding the characteristics of the systematic reviews and the associated COI disclosures. We conducted descriptive analyses.ResultsEighty percent of systematic reviews included authors' COI disclosures. Of the 160 systematic reviews that included COI disclosures, 15% had at least one author reporting at least one type of COI. The two most frequently reported types of COI were individual financial COI and individual scholarly COI (11% and 4% respectively). Institutional COIs were less commonly reported than individual COIs (3% and 15% respectively) and non-financial COIs were less commonly reported than financial COIs (6% and 14% respectively). Only one systematic review reported the COI disclosure by editors, and none reported disclosure by peer reviewers. All COI disclosures were in the form of a narrative statement in the main document and none in an online document.ConclusionA fifth of systematic reviews in HPSR do not include a COI disclosure statement, highlighting the need for journals to strengthen and/or better implement their COI disclosure policies. While only 15% of identified disclosure statements report any COI, it is not clear whether this indicates a low frequency of COI versus an underreporting of COI, or both.
| S-EPMC6077276 | biostudies-literature
Project description:ObjectiveTo describe the experiences of authors of Cochrane reviews in searching for, getting access to, and using unpublished data.DesignCross sectional study.SettingCochrane reviews.Participants2184 corresponding authors of Cochrane reviews as of May 2012.Main outcome measureFrequencies of responses to open ended and closed questions in an online survey.ResultsOf 5915 authors contacted by email, 2184 replied (36.9% response rate). Of those, 1656 (75.8%) had searched for unpublished data. In 913 cases (55.1% of 1656), new data were obtained and we received details about these data for 794 data sources. The most common data source was "trialists/investigators," accounting for 73.9% (n=587) of the 794 data sources. Most of the data were used in the review (82.0%, 651/794) and in 53.4% (424/794) of cases data were provided in less than a month. Summary data were most common, provided by 50.8% (403/794) of the data sources, whereas 20.5% (163/794) provided individual patient data. In only 6.3% (50/794) of cases were data reported to have been obtained from the manufacturers, and this group waited longer and had to make more contacts to get the data. The data from manufacturers were less likely to be for individual patients and less likely to be used in the review. Data from regulatory agencies accounted for 3.0% (24/794) of the obtained data.ConclusionsMost authors of Cochrane reviews who searched for unpublished data received useful information, primarily from trialists. Our response rate was low and the authors who did not respond were probably less likely to have searched for unpublished data. Manufacturers and regulatory agencies were uncommon sources of unpublished data.
| S-EPMC3633324 | biostudies-literature
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.
| S-EPMC10501528 | biostudies-literature
Project description:ObjectiveSystematic reviews can include cluster-randomised controlled trials (C-RCTs), which require different analysis compared with standard individual-randomised controlled trials. However, it is not known whether review authors follow the methodological and reporting guidance when including these trials. The aim of this study was to assess the methodological and reporting practice of Cochrane reviews that included C-RCTs against criteria developed from existing guidance.MethodsCriteria were developed, based on methodological literature and personal experience supervising review production and quality. Criteria were grouped into four themes: identifying, reporting, assessing risk of bias, and analysing C-RCTs. The Cochrane Database of Systematic Reviews was searched (2nd December 2013), and the 50 most recent reviews that included C-RCTs were retrieved. Each review was then assessed using the criteria.ResultsThe 50 reviews we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013. For identifying C-RCTs, only 56% identified that C-RCTs were eligible for inclusion in the review in the eligibility criteria. For reporting C-RCTs, only eight (24%) of the 33 reviews reported the method of cluster adjustment for their included C-RCTs. For assessing risk of bias, only one review assessed all five C-RCT-specific risk-of-bias criteria. For analysing C-RCTs, of the 27 reviews that presented unadjusted data, only nine (33%) provided a warning that confidence intervals may be artificially narrow. Of the 34 reviews that reported data from unadjusted C-RCTs, only 13 (38%) excluded the unadjusted results from the meta-analyses.ConclusionsThe methodological and reporting practices in Cochrane reviews incorporating C-RCTs could be greatly improved, particularly with regard to analyses. Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic reviews incorporating C-RCTs.
| S-EPMC4794236 | biostudies-literature
Project description:ImportanceConflicts of interest (COI) disclosure policies are critical to enhancing the integrity of research. However, it is unclear how Chinese medical journals interpret and enforce such policies.ObjectivesThe goal of this investigation is to determine the current status of COI disclosure policy enforcement in Chinese medical journals and to promote comprehensive COI policies.MethodsIn this cross-sectional study conducted from September 1st to October 29th 2017, journal instructions, websites and print issues of journals indexed by the Core Journals of China (version 2014), in the medical and health sector, were reviewed to identify whether COI disclosure policies existed and how complete these policies were.ResultsOf 248 eligible journals, 78 (31%) mentioned COI policies; 9 (4%) applied standardized disclosure forms; 18 (7%) required disclosure statements in articles; 4 (2%) mentioned policy bases; none validated disclosed COIs; 2 (1%) mentioned how they dealt with breaches; 18 (7%) involved the management of disclosed COIs; and 62 (25%) and 55 (22%) noted financial and nonfinancial COIs, respectively. Seventy-eight journals (31%) mentioned COIs in research and authors' obligation towards disclosure; 2 (1%) and 6 (2%) mentioned family members' and institutional COIs, respectively. Twenty-two and 11 journals mentioned at least one form of financial and nonfinancial COI type in research, respectively. Seven journals (3%) required disclosure of the source of financial support in research, but no journals mentioned the amount of support. Seven (3%) and 12 (5%) journals mentioned COIs in the editorial process and peer-review, respectively. Clinical journals (45%) paid more attention to COI policies than non-clinical journals.ConclusionsApproximately one-third of Chinese medical journals had COI policies, and of the journals that mentioned financial COIs most required nonfinancial COIs. However, the extent to which journals implemented COI policies was insufficient. There is a generic lack of standardized disclosure forms and management of COIs in most journals. The subject and details of COIs involved in the editorial and peer-review process received less attention than those in research.
| S-EPMC6615603 | biostudies-literature
Project description:BACKGROUND:Despite the growing reputation and subject coverage of the Cochrane Database of Systematic Reviews, many systematic reviews continue to be published solely in paper-based health care journals. This study was designed to determine why authors choose to publish their systematic reviews outside of the Cochrane Collaboration and if they might be interested in converting their reviews to Cochrane format for publication in the Cochrane Database of Systematic Reviews. METHODS:Cross-sectional survey of Australian primary authors of systematic reviews not published on the Cochrane Database of Systematic Reviews identified from the Database of Abstracts of Reviews of Effectiveness. RESULTS:We identified 88 systematic reviews from the Database of Abstracts of Reviews of Effectiveness with an Australian as the primary author. We surveyed 52 authors for whom valid contact information was available. The response rate was 88 per cent (46/52). Ten authors replied without completing the survey, leaving 36 valid surveys for analysis. The most frequently cited reasons for not undertaking a Cochrane review were: lack of time (78%), the need to undergo specific Cochrane training (46%), unwillingness to update reviews (36%), difficulties with the Cochrane process (26%) and the review topic already registered with the Cochrane Collaboration (21%). (Percentages based on completed responses to individual questions.) Nearly half the respondents would consider converting their review to Cochrane format. Dedicated time emerged as the most important factor in facilitating the potential conversion process. Other factors included navigating the Cochrane system, assistance with updating and financial support. Eighty-six per cent were willing to have their review converted to Cochrane format by another author. CONCLUSION:Time required to complete a Cochrane review and the need for specific training are the primary reasons why some authors publish systematic reviews outside of the Cochrane Collaboration. Encouragingly, almost half of the authors would consider converting their review to Cochrane format. Based on the current number of reviews in the Database of Abstracts of Reviews of Effectiveness, this could result in more than 700 additional Cochrane reviews. Ways of supporting these authors and how to provide dedicated time to convert systematic reviews needs further consideration.
| S-EPMC149345 | biostudies-literature
Project description:BackgroundChinese herbal medicines (CHMs) are the major interventions of traditional Chinese medicine (TCM), which are typically administered as either single herbs or formulas. The Cochrane systematic reviews (SRs) of CHMs are essential references for evaluating the efficacy and safety of CHMs interventions; they are expected to be accurate and reliable. This study aimed to assess the reporting quality of these SRs, particularly whether necessary information related to CHM was adequately reported.MethodsThe Cochrane Database was systematically searched for all SRs of CHM that were published up to 31 December 2017. The primary analysis was to assess their reporting quality based on 27-item of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and 9-item of CHM-related information designed according to TCM theory. Descriptive statistics were additionally used to analyze their baseline characteristics.ResultsA total of 109 Cochrane SRs of CHM were identified from 1999 to 2017. For 27-item of PRISMA, 26 had the reporting compliances higher than 50%, of which 11 were fully reporting (100%). However, for CHM-related information, 65 (59.6%) SRs did not report the specific name of the CHM in the title, 42 (38.5%) lacked TCM-related rationales in the introduction, 62 (56.9%) did not include CHM-related characteristics in the additional analyses, and 77 (70.6%) did not analyze CHM results in terms of TCM-related theories in the discussion. Of 97 SRs that included clinical trials, 38 (39.2%) did not provide the details of composition and dosage of CHMs, 85 (87.6%) did not report the CHM sources, 13 (13.4%) did not provide the dosage form, 95 (97.9%) lacked CHM quality control information, and 57 (58.8%) did not describe details of the controls. For 62 (72.9%) of 85 SRs that included meta-analysis, it was impossible to assess whether meta-analysis had been properly conducted due to inadequate reporting of CHM interventions.ConclusionAlthough the Cochrane SRs of CHM showed reporting compliance with PRISMA checklist, their reporting quality needs improvement, especially about full reporting of CHM interventions and of TCM-related rationales. Reporting guideline of "PRISMA extension for CHM interventions" should be developed thus to improve their quality.
| S-EPMC6892158 | biostudies-literature