Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review.
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ABSTRACT: Objective
To systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).Methods
In this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.Results
Among the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.Conclusion
There are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.
SUBMITTER: Tabatabavakili S
PROVIDER: S-EPMC8105509 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAuthors of clinical practice guidelines (CPGs) disclose financial conflicts of interest (FCOIs) to promote transparency ethics. Typically, they do so on standard declaration forms containing generic open-ended questions on FCOIs. Yet, the literature is scant on the format and effect of alternative disclosure forms. Does supplementing a standard form with subsequent detailed disclosure forms tailored to the context of the CPG improve the yield or accuracy of FCOIs declarations?MethodsFor an international CPG in gastroenterology on the endoscopic surveillance for colorectal neoplasia in inflammatory bowel disease, we compared the use of a standard FCOIs disclosure form with a contextual FCOIs disclosure form that detailed commercial relations related to the CPG topic. This included manufacturers of endoscopes, endoscopy equipment and accessories. Participants completed the generic form early, and the supplementary contextual form six months later. We then compared the FCOI disclosures obtained.Findings26 participants provided FCOIs disclosures using both disclosure forms. We found discrepancies regarding (1) the disclosure of FCOIs (presence/absence), and (2) the listing of financial entities. While the number of participants who disclosed a FCOI remained the same (30.8%) using the two forms, disclosures were not from the same individuals: two additional participants disclosed a FCOI, whereas two participants withdrew previous disclosures. Among those who reported a FCOI in either form, we noted inconsistencies in disclosures for 70% of the participants. This included changes in FCOIs disclosure status or modifications of "their commercial relations".DiscussionAccurate reporting of FCOIs advances the transparency and ethical integrity of CPGs. Our experience suggests that a contextual FCOIs disclosure form tailored to content of the CPG with narrow, detailed questions provides supplementary, more complete FCOIs declarations than generic forms alone. The finding raises challenges on how forms are best written and formatted, optimally timed, and more effectively processed with sensitivity to professional behaviour, so as to heighten transparency.
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Project description:ObjectiveTo determine the prevalence of financial conflicts of interest among members of panels producing clinical practice guidelines on screening, treatment, or both for hyperlipidaemia or diabetes.DesignCross sectional study.SettingRelevant guidelines published by national organisations in the United States and Canada between 2000 and 2010.ParticipantsMembers of guideline panels.Main outcome measuresPrevalence of financial conflicts of interest among members of guideline panels and chairs of panels.ResultsFourteen guidelines met our search criteria, of which five had no accompanying declaration of conflicts of interest by panel members. 288 panel members had participated in the guideline development process. Among the 288 panel members, 138 (48%) reported conflicts of interest at the time of the publication of the guideline and 150 (52%) either stated that they had no such conflicts or did not have an opportunity to declare any. Among 73 panellists who formally declared no conflicts, 8 (11%) were found to have one or more. Twelve of the 14 guideline panels evaluated identified chairs, among whom six had financial conflicts of interest. Overall, 150 (52%) panel members had conflicts, of which 138 were declared and 12 were undeclared. Panel members from government sponsored guidelines were less likely to have conflicts of interest compared with guidelines sponsored by non-government sources (15/92 (16%) v 135/196 (69%); P<0.001).ConclusionsThe prevalence of financial conflicts of interest and their under-reporting by members of panels producing clinical practice guidelines on hyperlipidaemia or diabetes was high, and a relatively high proportion of guidelines did not have public disclosure of conflicts of interest. Organisations that produce guidelines should minimise conflicts of interest among panel members to ensure the credibility and evidence based nature of the guidelines' content.
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Project description:Background. Tobacco companies have actively promoted the substitution of cigarettes with purportedly safer tobacco products (e.g., smokeless tobacco, e-cigarettes) as tobacco harm reduction (THR). Given the tobacco, e-cigarette, and pharmaceutical industries' substantial financial interests, we quantified industry influence on support for THR. Objectives. To analyze a comprehensive set of articles published in peer-reviewed journals assessing funding sources and support for or opposition to substitution of tobacco or nicotine products as harm reduction. Search Methods. We searched PubMed, Embase, Web of Science, and PsycINFO with a comprehensive search string including all articles, comments, and editorials published between January 1, 1992, and July 26, 2016. Selection Criteria. We included English-language publications published in peer-reviewed journals addressing THR in humans and excluded studies on modified cigarettes, on South Asian smokeless tobacco variants, on pregnant women, on animals, not mentioning a tobacco or nicotine product, on US Food and Drug Administration-approved nicotine replacement therapies, and on nicotine vaccines. Data Collection and Analysis. We double-coded all articles for article type; primary product type (e.g., snus, e-cigarettes); themes for and against THR; stance on THR; THR concepts; funding or affiliation with tobacco, e-cigarette, pharmaceutical industry, or multiple industries; and each author's country. We fit exact logistic regression models with stance on THR as the outcome (pro- vs anti-THR) and source of funding or industry affiliation as the predictor taking into account sparse data. Additional models included article type as the outcome (nonempirical or empirical) and industry funding or affiliation as predictor, and stratified analyses for empirical and nonempirical studies with stance on THR as outcome and funding source as predictor. Main Results. Searches retrieved 826 articles, including nonempirical articles (21%), letters or commentaries (34%), editorials (5%), cross-sectional studies (15%), systematic reviews and meta-analyses (3%), and randomized controlled trials (2%). Overall, 23.9% disclosed support by industry; 49% of articles endorsed THR, 42% opposed it, and 9% took neutral or mixed positions. Support from the e-cigarette industry (odds ratio [OR]?=?20.9; 95% confidence interval [CI]?=?5.3, 180.7), tobacco industry (OR?=?59.4; 95% CI?=?10.1, +infinity), or pharmaceutical industry (OR?=?2.18; 95% CI?=?1.3, 3.7) was significantly associated with supportive stance on THR in analyses accounting for sparse data. Authors' Conclusions. Non-industry-funded articles were evenly divided in stance, while industry-funded articles favored THR. Because of their quantity, letters and comments may influence perceptions of THR when empirical studies lack consensus. Public Health Implications. Public health practitioners and researchers need to account for industry funding when interpreting the evidence in THR debates.
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Project description:Background There is a high prevalence of financial conflicts of interest (COI) between physicians and industry. Objectives To conduct a systematic review with meta-analysis examining the completeness of self-reported financial COI disclosures by physicians, and identify factors associated with non-disclosure. Data sources MEDLINE, Embase and PsycINFO were searched for eligible studies up to April 2020 and supplemented with material identified in the references and citing articles. Data extraction and synthesis Data were independently abstracted by two authors. Data synthesis was performed via systematic review of eligible studies and random-effects meta-analysis. Main outcomes and measures The proportion of discrepancies between physician self-reported disclosures and objective payment data was the main outcome. The proportion of discrepant funds and factors associated with non-disclosure were also examined. Results 40 studies were included. The pooled proportion of COI discrepancies at the article level was 81% (range: 54%–98%; 95% CI 72% to 89%), 79% at the payment level (range: 71%–89%; 95% CI 67% to 89%), 93% at the authorship level (range: 71%–100%; 95% CI 79% to 100%) and 66% at the author level (range: 8%–99%; 95% CI 48% to 78%). The proportion of funds discrepant was 33% (range: 2%–77%; 95% CI 12% to 58%). There was high heterogeneity between studies across all five analyses (I2=94%–99%). Most undisclosed COI were related to food and beverage, or travel and lodging. While the most common explanation for failure to disclose was perceived irrelevance, a median of 45% of non-disclosed payments were directly or indirectly related to the work. A smaller monetary amount was the most common factor associated with nondisclosure. Conclusions Physician self-reports of financial COI are highly discrepant with objective data sources reporting payments from industry. Stronger policies are required to reduce reliance on physician self-reporting of financial COI and address non-compliance.
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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.
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Project description:Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
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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.
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Project description: Not available
| S-EPMC8610564 | biostudies-literature
Project description:Accurate disclosure of financial conflicts of interest (COI) among clinical practice guideline (CPG) developers is critical to ensure the quality of CPGs. However, there is limited evidence on the impact of underreporting COIs on the quality of CPGs. This study aimed to examine the proportion of underreported COI disclosures in the development of Japanese CPGs and to estimate the association between underreported COIs and CPG quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II. Twenty-three Japanese CPGs published in 2019 and their 1114 developers were included in the study. The results show that underreporting of COIs occurred in 52% of the included CPGs and 8% of all CPG developers. Underreporting COI disclosures was negatively associated with low-quality CPG (Odds ratio [OR], 0.57; 95% confidence interval [CI]: 0.11, 3.04). On the other hand, CPGs that had more than 13% of CPG developers with voting rights on recommendation decisions and underreporting of COI disclosures were positively associated with low quality (OR, 1.78; 95% CI: 0.25, 12.45). For individual CPG developers with voting rights for recommendation decisions, the presence of a COI was positively associated with low quality (OR, 1.11; 95% CI: 0.71, 1.75). This study demonstrates that the involvement and underreporting of COIs did not seriously distort the CPG development process. However, the COI-related factors of CPG developers with voting rights for recommendation decisions may be associated with low CPG quality.
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Project description:BackgroundThe reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest (COI). Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To continuously assess COI declaration and management in German guidelines we established the public database LeitlinienWatch (GuidelineWatch).MethodsWe analyzed all German guidelines at the highest methodological level (S3) that included recommendations for pharmacological therapy (n = 67) according to five criteria: declaration and assessment of COI, composition of the guideline development group, independence of the coordinators and lead authors, imposed abstentions because of COI and public external review. Each criterion was assessed using predefined outcome categories.ResultsMost guidelines (76%) contained a detailed declaration of COI. However, none of the guidelines provided full transparency of COI assessment results. The guideline group was composed of a majority of participants with COI in 55% of the guidelines, no guideline was free of participants with COI. Only 9% of guidelines had coordinators and lead authors without any financial COI. Most guidelines (70%) did not provide a rule for abstentions for participants with COI. In 21% of guidelines there was a rule, but abstentions were either not practiced or not documented, whereas in 7% partial abstentions and in 2% complete abstentions were documented. Two thirds of the guideline drafts (67%) were not externally reviewed via a public website.ConclusionsCOI are usually documented in detail in German guidelines of the highest methodological level. However, considerable improvement is needed regarding active management of COI, including recruitment of independent experts for guideline projects, abstention from voting for participants with COI and external review of the guideline draft. We assume that the publicly available ratings on GuidelineWatch will improve the handling of conflicts of interest in guideline development.
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