Author Financial Conflicts of Interest, Industry Funding, and Clinical Practice Guidelines for Anticancer Drugs

2015 ◽  
Vol 33 (1) ◽  
pp. 100-106 ◽  
Author(s):  
Ariadna Tibau ◽  
Philippe L. Bedard ◽  
Amirrtha Srikanthan ◽  
Josee-Lyne Ethier ◽  
Francisco E. Vera-Badillo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflicts Of Interest ◽  
Guideline Development ◽  
Industry Funding ◽  
Funding Sources ◽  
Consensus Statements ◽  
Financial Conflicts Of Interest ◽  
Based Medicine

Purpose Clinical practice guidelines (CPGs) and consensus statements (CSs) are used to apply evidence-based medicine or expert recommendations to clinical practice. Here we explore author financial conflicts of interest (FCOIs), sources of guideline funding, and their relationship with endorsement of specific drugs. Methods An electronic search of MEDLINE was conducted to identify CPGs and CSs for common solid cancers published between January 2003 and October 2013. The search was restricted to articles evaluating systemic therapy. We extracted data on self-reported author FCOIs, funding sources, use of manuscript writers, and endorsement of specific drugs in the abstract of the article. Results Of 142 articles evaluated, 64% were CPGs, and 36% were CSs. The proportion of articles reporting FCOIs improved from 11% in 2003 to 93% in 2013 (P for trend < .001). Only 45% of articles explicitly reported funding sources. Of these, 65% disclosed partial or full industry sponsorship. Use of manuscript writers was declared in 13%, but many articles did not explicitly report the role of authors in the writing of the manuscript. Endorsement of specific drugs was significantly associated with author FCOIs (odds ratio [OR], 7.29; P = .001), but not with industry funding (OR, 0.95; P = .37). Conclusion Reporting of FCOIs in CPGs and CSs has improved over time. Despite prevalent funding of guideline development by industry, such funding is not associated with endorsement of specific drugs. Author FCOIs are prevalent, and endorsement of a specific drug seems to be more common when authors have FCOIs with the pharmaceutical company marketing that drug.

scholarly journals Transparency ethics in practice: Revisiting financial conflicts of interest disclosure forms in clinical practice guidelines

PLoS ONE ◽  
2017 ◽  
Vol 12 (8) ◽  
pp. e0182856 ◽  
Author(s):  
Yidan Lu ◽  
Derek J. Jones ◽  
Nour Sharara ◽  
Tonya Kaltenbach ◽  
Loren Laine ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflicts Of Interest ◽  
Financial Conflicts Of Interest

scholarly journals The structure of the quality of clinical practice guidelines with the items and overall assessment in AGREE II: a regression analysis

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Yosuke Hatakeyama ◽  
Kanako Seto ◽  
Rebeka Amin ◽  
Takefumi Kitazawa ◽  
Shigeru Fujita ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflicts Of Interest ◽  
Agree Ii ◽  
Domain 3 ◽  
Based Medicine ◽  
The Relationship

Abstract Background The Appraisal of Guidelines for Research & Evaluation (AGREE) II has been widely used to evaluate the quality of clinical practice guidelines (CPGs). While the relationship between the overall assessment of CPGs and scores of six domains were reported in previous studies, the relationship between items constituting these domains and the overall assessment has not been analyzed. This study aims to investigate the relationship between the score of each item and the overall assessment and identify items that could influence the overall assessment. Methods All Japanese CPGs developed using the evidence-based medicine method and published from 2011 to 2015 were used. They were independently evaluated by three appraisers using AGREE II. The evaluation results were analyzed using regression analysis to evaluate the influence of 6 domains and 23 items on the overall assessment. Results A total of 206 CPGs were obtained. All domains and all items except one were significantly correlated to the overall assessment. Regression analysis revealed that Domain 3 (Rigour of Development), Domain 4 (Clarity of Presentation), Domain 5 (Applicability), and Domain 6 (Editorial Independence) had influence on the overall assessment. Additionally, four items of AGREE II, clear selection of evidence (Item 8), specific/unambiguous recommendations (Item 15), advice/tools for implementing recommendations (Item 19), and conflicts of interest (Item 22), significantly influenced the overall assessment and explained 72.1% of the variance. Conclusions These four items may highlight the areas for improvement in developing CPGs.

scholarly journals Protocol of an interdisciplinary consensus project aiming to develop an AGREE II extension for guidelines in surgery

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e037107
Author(s):  
George A Antoniou ◽  
Dimitris Mavridis ◽  
Sofia Tsokani ◽  
Manuel López-Cano ◽  
Iván D Flórez ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflicts Of Interest ◽  
Guideline Development ◽  
Reporting Quality ◽  
Consensus Conference ◽  
Professional Staff ◽  
Delphi Panel ◽  
Agree Ii

IntroductionAppraisal of Guidelines for Research and Evaluation (AGREE II) is an instrument that informs development, reporting and assessment of clinical practice guidelines. Previous research has demonstrated the need for improvement in methodological and reporting quality of clinical practice guidelines specifically in surgery. We aimed to develop an AGREE II extension document for application in surgical guidelines.Methods and analysisWe have performed a structured literature review and assessment of guidelines in surgery using the AGREE II instrument. In exploratory analyses, we have identified factors associated with guideline quality. We have performed reliability and factor analyses to inform the development of an extension document. We will summarise this information and present it to a Delphi panel of stakeholders. We will perform iterative Delphi rounds and we will summarise the final results to develop the extension instrument in a dedicated consensus conference.Ethics and disseminationFunding bodies will not be involved in the development of the instrument. Research ethics committee and Health Research Authority approval was waived, since this is a professional staff study only and no duty of care lies with the National Health Service to any of the participants. Conflicts of interest, if any, will be addressed by reassigning functions or replacing participants with relevant conflicts. The results will be disseminated through publication in peer reviewed journals, the funders’ websites, social media and direct contact with guideline development organisations and peer-reviewed journals that publish guidelines.

Sa1014 – Prevalence and Relevance of Financial Conflicts of Interest Among Clinical Practice Guidelines in Nutrition

2019 ◽  
Vol 156 (6) ◽  
pp. S-254-S-255
Author(s):  
Alexa Sasson ◽  
Rishad Khan ◽  
Michael A. Scaffidi ◽  
Rishi Bansal ◽  
Jeevan Dhillon ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflicts Of Interest ◽  
Financial Conflicts Of Interest

A critical evaluation of oncology clinical practice guidelines.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6020-6020
Author(s):  
Bradley Norman Reames ◽  
Robert Wallace Krell ◽  
Sarah Nicks Ponto ◽  
Sandra L. Wong
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Public Involvement ◽  
Conflicts Of Interest ◽  
Critical Evaluation ◽  
Small Cell ◽  
Small Cell Lung ◽  
Consensus Statements ◽  
The Us

6020 Background: Clinical Practice Guidelines (CPGs) play an essential role in cancer care today, but there are significant concerns regarding their content and reliability. In 2011, the Institute of Medicine (IOM) report “Clinical Practice Guidelines We Can Trust” created standards for developing trustworthy CPGs. Using these standards as a benchmark, we sought to evaluate recent oncology guidelines. Methods: CPGs and consensus statements addressing the screening, evaluation or management of the four leading causes of cancer-related mortality in the US (non-small cell lung, breast, prostate and colorectal cancers) published between January 2005 and December 2010 were identified using MEDLINE. A standardized scoring system based on the eight standards set forth by the IOM was devised, and the methodology, content and disclosure policies of CPGs were critically evaluated by four independent reviewers. All CPGs were given two scores; points were awarded out of a possible 8 major criteria and 20 sub-criteria. Results: We identified 168 CPGs for inclusion in the study; 45% were from US groups. None of the CPGs fully met all the IOM standards. On average, CPGs only met 2.8 of 8 standards set forth by the IOM (mean 2.8 points out of 8, SD 1.7; 8.3 out of 20, SD 4.3). Less than half of CPGs were based on a systematic review. Only half of CPG panels addressed conflicts of interest. Overall, the CPGs were most consistent with IOM standards for transparency regarding the development process, articulation of recommendations, and use of external review. Most did not comply with standards for inclusion of patient and public involvement in the development or review process, nor did they specify their process for updating. CPGs from the US had higher overall scores than CPGs from international groups. CPGs addressing non-small cell lung cancer had higher overall scores (mean 3.9) than those for other cancers. Conclusions: The vast majority of oncology CPGs fails to meet the IOM standards for trustworthy guidelines. Notably, most CPGs are not based on systematic reviews, lack full disclosure, and do not include all relevant stakeholders in the guideline process. This highlights the need for improved CPG development processes.

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