Time trends in the reporting of conflicts of interest, funding and affiliation with industry in intensive care research: a systematic review

Darmon, Michaël; Boisramé-Helms, Julie; Jong, Audrey De; Hjortrup, Peter Buhl; Weiss, Emmanuel; Granholm, Anders; Pinciroli, Riccardo; Poussardin, Charlotte; Petersen, Marie Warrer; Sigaut, Stéphanie; Barreto, Bruna Brandão; Møller, Morten Hylander; Azoulay, Élie

doi:10.1007/s00134-018-5350-2

Cited by 12 publications

(12 citation statements)

References 26 publications

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“…Ten years later this proportion had grown to 15% [25], and even fewer guidelines provided information on how the COI had been managed. The proportion of guidelines that disclose COI of panel members has been shown to have further increased from 2006 to 2016 [26][27]. These data are in line with the finding of the present study.…”

Section: Discussionsupporting

confidence: 91%

Reporting of conflicts of interest and of sponsorship of guidelines in anaesthesiology. A cross-sectional study

2019

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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.

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Section: Discussionsupporting

confidence: 91%

Reporting of conflicts of interest and of sponsorship of guidelines in anaesthesiology. A cross-sectional study

2019

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“… 7 However, funding information was provided in only 41% of the studies. An analysis of 374 studies in critical care also showed a trend towards increased reporting of conflicts of interest (from 4% of studies in 2001 to 84% in 2016), 6 and in reporting of funding (from 17% to 59%, respectively). Why funding information provision in supportive and palliative oncology, or critical care, is lower than in trials of antibiotics (66%) is unclear.…”

Section: Discussionmentioning

confidence: 98%

“…1 2 However, RCTs have frequently been criticised for poor reporting of harms or adverse events. 3 4 Concerns have also been raised about the inadequacy of reporting of conflicts of interests and funding information, as those may influence-or appear to influence-trial design, its conduct, reporting of results, their interpretation and conclusions, [5][6][7][8][9][10][11][12] in turn jeopardising public trust. 13 A clear and transparent reporting of studies is therefore needed to assess both their internal and external validity.…”

Section: Introductionmentioning

confidence: 99%

Reporting of adverse events, conflict of interest and funding in randomised controlled trials of antibiotics: a secondary analysis

et al. 2021

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ObjectivesTransparent reporting of trials is necessary to assess their internal and external validity. Currently, little is known about the quality of reporting in antibiotics trials. Our study investigates the reporting of adverse events, conflicts of interest and funding information in trials of penicillins, cephalosporins and macrolides.DesignA secondary analysis of trials included in a convenience sample of three systematic reviews.MethodsAll randomised controlled trials included in the systematic reviews were included, although duplicates were removed. Eligible trials compared the specified antibiotics to placebo, for any indication. Author pairs independently extracted the data on reporting of adverse events from parent reviews, and data on funding and conflict of interest information from the trial reports. We calculated the overall proportion of trials reporting adverse events, conflict of interest information and funding information, and their proportion before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) 2001 Statement.ResultsWe included 432 trials. Overall, 62% of trials reported adverse events of any kind, although reporting of deaths or antibiotic resistance was less frequent (20% and 37%, respectively). Conflict-of-interest information was provided in 26% of the trials, and funding information was provided in 66% of the trials. There was no significant difference in reporting of adverse events before and after the publication of CONSORT 2001 Statement (62% vs 62%, p=0.92). Conflict of interest statements were provided more frequently (2% vs 55%, p<0.001) and conflict was present more often (0% vs 14%, p<0.001). There was no difference in the provision of the information about trial funding before (62%) and after (70%) CONSORT 2001 publication.ConclusionsInformation about adverse events, conflict of interest and funding, remains under-reported in trials of antibiotics.

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“…A study from Michael Darmon et al that studied time trends in the reporting of conflicts of interest, funding, and affiliation with industry in intensive care research found that from the 374 studies that they evaluated, conflicts of interest statements was available in 65% of the studies and 8% had declared conflicts of interest. Their study suggested that conflicts of interest reporting have been unreliable before the International Committee of Medical Journal Editors (ICMJE) statements (Darmon et al, 2018). A study by Cole Wayant et al studied financial conflicts of interest among oncologist authors and clinical drug trials studied 1007 authors of whom 344 oncologist authors from 43 published trials were included in their study.…”

Section: Research Oversight Issuesmentioning

confidence: 99%

Critical and Comprehensive Ethical Analysis on Pragmatic Randomized Controlled Trials

Hossain¹

2020

Preprint

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The interest of pragmatic randomized controlled trials continues to increase as they are much better suited for studies of how to get medical and health services out into wider practice. However, despite the advantage that such trials have, there are several ethical issues and medical ethics issues that persist with the trial. The ethical and medical ethics issues involve research-practice distinction, consent, disclosure, vulnerable populations, oversight, ethical principles, ethical framework, regulatory frameworks, and conflicts of interest. Through performing an elaborate literature review and analyzing claims and arguments made within the literature, we will provide a critical and comprehensive ethical analysis on pragmatic randomized controlled trials, and we will begin the discussion on conflicts of interest in pragmatic RCTs, arguing that conflicts of interest occur in pragmatic RCTs.

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Time trends in the reporting of conflicts of interest, funding and affiliation with industry in intensive care research: a systematic review

Abstract: Our study suggests COI reporting to have been unintuitive to most investigators and unreliable before ICMJE statements, and that strong incentives are needed to implement adequate reporting of COI.

Cited by 12 publications

References 26 publications

Reporting of conflicts of interest and of sponsorship of guidelines in anaesthesiology. A cross-sectional study

Reporting of conflicts of interest and of sponsorship of guidelines in anaesthesiology. A cross-sectional study

Reporting of adverse events, conflict of interest and funding in randomised controlled trials of antibiotics: a secondary analysis

Critical and Comprehensive Ethical Analysis on Pragmatic Randomized Controlled Trials

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