Dataset Information

Conflict of interest in clinical practice guideline development: a systematic review.

ABSTRACT:

Background

There is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations.

Methodology/principal findings

We searched Medline (1980 to March, 2011) for studies that examined the effect of COI on CPG development and/or recommendations. Data synthesis was qualitative. Twelve studies fulfilled inclusion criteria; 9 were conducted in the US. All studies reported on financial relationships of CPG authors with the pharmaceutical industry; 1 study also examined relationships with diagnostic testing and insurance companies. The majority of guidelines had authors with industry affiliations, including consultancies (authors with relationship, range 6-80%); research support (4-78%); equity/stock ownership (2-17%); or any COI (56-87%). Four studies reported multiple types of financial interactions for individual authors (number of types per author: range 2 to 10 or more). Data on the effect of COI on CPG recommendations were confined to case studies wherein authors with specific financial ties appeared to benefit from the related CPG recommendations. In a single study, few authors believed that their relationships influenced their recommendations. No studies reported on intellectual COI in CPGs.

Conclusions/significance

There are limited data describing the high prevalence of COI among CPG authors, and only case studies of the effect of COI on CPG recommendations. Further research is needed to explore this potential source of bias.

SUBMITTER: Norris SL

PROVIDER: S-EPMC3198464 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Publications

Conflict of interest in clinical practice guideline development: a systematic review.

Norris Susan L SL Holmer Haley K HK Ogden Lauren A LA Burda Brittany U BU

PloS one 20111019 10

<h4>Background</h4>There is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations.<h4>Methodology/principal findings</h4>We searched Medline (1980 to March, 2011) fo ...[more]

PMID: 22039406

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Project description:ImportanceClinical practice guidelines (CPGs) are important in advancing the quality of medical care. Financial relationships between physicians and pharmaceutical companies may influence clinical practice. In accordance with the Japan Pharmaceutical Manufacturers Association guidelines for transparency, pharmaceutical company payments to physicians have been disclosed since 2013. The distribution of pharmaceutical company payments among CPG authors in Japan has not been studied.ObjectivesTo determine the characteristics and distribution of payments made by pharmaceutical companies to authors of oncologic CPGs in Japan and to assess the transparency of policies associated with conflict of interest (COI) disclosures in CPGs.Design, setting, and participantsThis retrospective cross-sectional study of 326 authors from 6 prominent oncologic CPGs from Japan included annual payment data for 2016 from 78 pharmaceutical companies during varying times from January 1, 2016, through September 30, 2017.Main outcomes and measuresAmount and proportion of payments made by pharmaceutical companies to the authors; amount and proportion of payments made to the authors of each guideline; and information on policies for disclosing COIs in CPGs (Japanese yen were converted to US dollars based on the February 20, 2019 exchange rate of 110 yen per 1 US dollar).ResultsOf 326 eligible authors, 255 (78.2%) received payments from pharmaceutical companies in 2016. The total number of payments was 3947, and the total amount was $3 444 193 (¥378 861 220), including $2 696 777 for speaking, $181 944 for writing, $554 381 for consulting, and $11 091 for unclear fees. The median payment amount was $3233 (interquartile range [IQR], $506-$10 873), and the mean (SD) payment amount was $10 565 ($20 059); 84 authors (25.8%) received more than $10 000. The largest proportions of CPG authors receiving at least 1 payment were those for gastric carcinoma (92%) and colorectal carcinoma (92%). The median payment was highest for authors of colorectal carcinoma guidelines ($7781; IQR, $2506-$18 633), whereas it was lowest for authors of pancreatic carcinoma guidelines ($2207; IQR, $304-$9240). Only breast carcinoma CPGs published the authors' individual COI disclosure in an identifiable matter; guidelines for lung, colorectal, pancreatic, and hepatocellular carcinomas disclosed the financial relationships between the authors and companies anonymously; and the gastric carcinoma CPGs did not have a COI disclosure section.Conclusions and relevanceMost oncologic CPG authors received payments from pharmaceutical companies, and COI disclosure methods appeared to be insufficient. Given the possibility of bias in guideline content if authors have any financial relationships with pharmaceutical companies, CPGs from Japan may require improved transparency.

Project description:BackgroundConflicts of interest (COI) jeopardize the validity of Clinical Practice Guidelines (CPGs). When the Institute of Medicine promulgated COI policies in 2011, few organizations met these requirements, but it is unknown if organizations have improved their policies since that time. We sought to evaluate current adherence to IOM standards of COI policies.Methods and findingsWe conducted a retrospective document review of COI policies and CPGs from organizations that published five or more CPGs between January 1, 2018 and December 31, 2019. Organizations were identified via CPG databases. COI policies were obtained from an internet search. We collected data on i) the number of organizations that have COI policies specific to CPG development, ii) the number of policies meeting each IOM standard and iii) the number of IOM standards met by each policy. COI disclosures from five CPGs of each organization were assessed for adherence to IOM standards. Among the 46 organizations that published 5 or more CPGs, 36 (78%) had a COI policy. Standard 2.2b (requiring divestment of financial COI) was met least frequently, by 2 of 36 (6%) organizations. Standard 2.1 (requiring disclosure of COI) was met most frequently, by 33 of 36 (92%) organizations. A total of 31 of 36 (86%) organizations met 4 or fewer of the 7 IOM standards. Among the 16 organizations limiting COI to a minority of the CPG panel (standard 2.4c) and the 15 organizations prohibiting COI among chairs or co-chairs (standard 2.4d), 12 (75%) and 10 (67%) organizations violated the respective standard in at least one CPG. The main limitations of our study are the exclusion of organizations producing fewer CPGs and ability to assess only publicly available policies.ConclusionAmong organizations producing CPGs, COI policies frequently do not meet IOM standards, and organizations often violate their own policies. These shortcomings may undermine the public trust in and thus the utility of CPGs. CPG-producing organizations should improve their COI policies and their strategies to manage COI to increase the trustworthiness of CPGs.

Project description:Depression affects over 300 million individuals worldwide and is responsible for most of the 800,000 annual suicides. Clinical practice guidelines (CPGs) for treatment of depression, founded on scientific evidence, are essential to improve patient care. However, economic and sociocultural factors may influence CPG elaboration, potentially leading to divergences in their recommendations. Consequently, we analyzed pharmacological recommendations for the treatment of depression from the most relevant CPGs. We included four CPGs with scores ? 80% for Domain 3 (rigor of development) on the Appraisal of Guidelines for Research and Evaluation and two other commonly used CPGs. The recommendations, their strengths, and the level of evidence were extracted from each CPG by two independent researchers and grouped as follows: (1) general recommendations for the pharmacological treatment for depression (suicide risk, acute treatment, continuation and maintenance phases, and treatment discontinuation); (2) treatment of non-responsive or partially responsive patients; and (3) treatment for subtypes of depression (chronic, psychotic, catatonic, melancholic, seasonal, somatic, mixed, and atypical). Only 50% of CPGs included recommendations for the risk of suicide associated with pharmacotherapy. All CPGs included serotonin selective reuptake inhibitors (SSRIs) as first-line treatment; however, one CPG also included agomelatine, milnacipran, and mianserin as first-line alternatives. Recommendations for depression subtypes (catatonic, atypical, melancholic) were included in three CPGs. The strength of recommendation and level of evidence clearly differed among CPGs, especially regarding treatment augmentation strategies. We conclude that, although CPGs converged in some recommendations (e.g., SSRIs as first-line treatment), they diverged in cardinal topics including the absence of recommendations regarding the risk of suicide associated with pharmacotherapy. Consequently, the recommendations listed in a specific CPG should be followed with caution.

Project description:IntroductionEvidence suggests the presence of deficiencies in the quality of care provided to up to half of all paediatric trauma patients in Canada, the USA and Australia. Lack of adherence to evidence-based recommendations may be driven by lack of knowledge of clinical practice guidelines (CPGs), heterogeneity in recommendations or concerns about their quality. We aim to systematically review CPG recommendations for paediatric injury care and appraise their quality.Methods and analysisWe will identify CPG recommendations through a comprehensive search strategy including Medical Literature Analysis and Retrieval System Online, Excerpta Medica dataBASE, Cochrane library, Web of Science, ClinicalTrials and websites of organisations publishing recommendations on paediatric injury care. We will consider CPGs including at least one recommendation targeting paediatric injury populations on any diagnostic or therapeutic intervention from the acute phase of care with any comparator developed in high-income countries in the last 15 years (January 2007 to a maximum of 6 months prior to submission). Pairs of reviewers will independently screen titles, abstracts and full text of eligible articles, extract data and evaluate the quality of CPGs and their recommendations using Appraisal of Guidelines Research and Evaluation (AGREE) II and AGREE Recommendations Excellence instruments, respectively. We will synthesise evidence on recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision framework and present results within a recommendations matrix.Ethics and disseminationEthics approval is not a requirement as this study is based on available published data. The results of this systematic review will be published in a peer-reviewed journal, presented at international scientific meetings and distributed to healthcare providers.Prospero registration numberInternational Prospective Register of Systematic Reviews (CRD42021226934).

Project description:Background and objectivesRigorous and transparent management strategies for conflicts of interest and clinical practice guidelines with the best available evidence are necessary for the development of nephrology guidelines. However, there was no study assessing financial and nonfinancial conflicts of interest, quality of evidence underlying the Japanese guidelines for CKD, and conflict of interest policies for guideline development.Design, setting, participants, & measurementsThis cross-sectional study examined financial and nonfinancial conflicts of interest among all 142 authors of CKD guidelines issued by the Japanese Society of Nephrology using a personal payment database from all 92 major Japanese pharmaceutical companies between 2016 and 2019 and self-citations by guideline authors. Also, the quality of evidence and strength of recommendations underlying the guidelines and conflicts of interest policies of Japanese, US, and European nephrology societies were evaluated.ResultsAmong 142 authors, 125 authors (88%) received $6,742,889 in personal payments from 56 pharmaceutical companies between 2016 and 2019. Four-year combined median payment per author was $8258 (interquartile range, $2230‒$51,617). The amounts of payments and proportion of guideline authors with payments remained stable during and after guideline development. The chairperson, vice chairperson, and group leaders received higher personal payments than other guideline authors. Of 861 references in the guidelines, 69 (8%) references were self-cited by the guideline authors, and 76% of the recommendations were on the basis of low or very low quality of evidence. There were no fully rigorous and transparent conflicts of interest policies for nephrology guideline authors in the United States, Europe, and Japan.ConclusionsMost of the Japanese CKD guideline recommendations were on the basis of low quality of evidence by the guideline authors tied with pharmaceutical companies, suggesting the need for better financial conflicts of interest management.

Dataset Information

Conflict of interest in clinical practice guideline development: a systematic review.

Background

Methodology/principal findings

Conclusions/significance

Publications

Conflict of interest in clinical practice guideline development: a systematic review.

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