Conflicts Of Interest And Funding In Medical Practice Guidelines: Review Of The Current Status And Development And Verification Of A Reporting Checklist

Background and objectives: Clinical practice guidelines provide essential guidance for healthcare workers to carry out their duties and serve as a bridge for timely translation of medical research evidence into practice.The quality of a guideline depends on the rigor of its development methodology and the adherence to standardized procedures.The disclosure and management of conflicts of interest(COI)among the contributors,as well as the disclosure and regulation of funding received by the guideline,will affect the quality of the guideline.Published studies have found complex relationships between guideline developers and the pharmaceutical industry,but disclosure of these interests tends to be incomplete in many guidelines.One reason for this is the lack of a dedicated reporting checklist to guide the reporting of disclosure of interests and the management of COI and funding.Therefore,we aimed to develop a checklist for the reporting of COI and funding in practice guidelines – the Reporting Items of Practice Guidelines in Healthcare for Conflicts of Interest and Funding(RIGHT-COI&F)statement.Methods: First,we performed a systematic review to analyze the content of COI and funding policies in existing guideline development manuals and identify their deficiencies.Second,a cross-sectional survey of studies investigating COI and funding in guidelines was performed to explore the current status of this topic and identify any related problems.Third,a questionnaire survey was carried out among guideline stakeholders to assess their knowledge about contents related to COI and funding in guidelines and to understand their needs.Fourth,an initial checklist was developed based on the results of the first three sub-projects,following the Guidelines for reporting health Research and leveraging experience from the development of the RIGHT Statement.A Delphi survey and a consensus meeting were held to reach consensus and formulate the final RIGHT-COI&F checklist.Finally,guidelines developed by the World Health Organization(WHO)and a representative sample of guideline development organizations’ COI and funding policies were evaluated using RIGHTCOI&F to verify the reliability and validity of the checklist.We conduct a survey on the ease of understanding of stakeholders of the RIGHT-COI&F checklist to test the feasibility of this checklist.Results: Fifty-three guideline COI policies and 27 guideline funding policies were included in the first sub-project.Disclosure of interests was mentioned in all COI policies.The definition of COI,the specification of who should disclose their interest,the evaluation of the disclosures of interest,the management of COI,and the publication of relevant information were mentioned in 35.8%,96.2%,64.2%,66.0%,and 52.8% of the COI policies,respectively.Of the funding policies,29.6% required reporting the funding sources,51.9% required stating that funding did not affect the recommendations of the guideline,29.6% reported the types of funding the guidelines should not accept,and 18.5% required limiting the participation of funders in the guideline development process.In the second sub-project,58 studies on COI in guidelines were identified.The reporting rates of COI at the guideline level and developer level ranged from 2% to93%,and 50% to 100%,respectively,across the studies.Thirteen studies addressed funding of guidelines,including disclosure,sources,and management.The disclosure rate of funding in the guidelines varied from 25% to 100% across different studies.In the third part of the project,342 valid questionnaires from China,Japan and South Korea were collected.Most(n=307,89.8%)respondents were aware of issues related to COI and funding in guidelines.Among these 307 respondents,44(14.3%)had participated in guideline development without filling out a declaration of interest form;and 287(93.5%)believed that standardizing the reporting of information on COI and funding in guidelines was necessary.The survey also provided some basic items for the formulation of the reporting checklist.The working groups for the development of RIGHT-COI&F consisted of 44 experts from 17 countries.The working groups included an advisory group(five members),a Delphi panel(27 members)and a coordination group(12 members).After one round of Delphi survey and three online consensus meetings,the RIGHT-COI&F checklist was finalized.The final checklist comprises 24 items grouped into two sections: COI of contributors to the guideline project(18 items)and funding of the guideline project(six items).The 24 items can also be categorized into policy-related items(16 items)and implementation-related items(eight items).Finally,RIGHT-COI&F was used to evaluate 62 WHO guidelines and the COI and funding policies of 28 guideline development organizations.The Cronbach’s αcoefficient was 0.787 for the policy-related items and 0.766 for the implementationrelated items.The Kaiser–Meyer–Olkin(KMO)test showed that the checklist had good construct validity.The mean scores for the ease of understanding were greater than five for all items,indicating that they are relatively easy to comprehend.The mean times to evaluate policies and guidelines using the applicable items of the RIGHT-COI&F checklist were 27.9 and 29.4 minutes,respectively.Conclusions: The existing guideline development manuals lack comprehensive and clear information on key aspects related to COI and funding,such as the disclosure,evaluation,management and reporting of COI of guideline developers,as well as the sources and utilization of guideline funding.Most guidelines are influenced by COI and funding,but the related information is often incomplete,opaque,and lacking standardization.Stakeholders widely agree that the reporting of contents related to COI and funding in guidelines needs overall improvement,in particular regarding the comprehensiveness of reporting.The development of the RIGHT-COI&F checklist adhered strictly to established and internationally recognized methods for developing a reporting checklist,and the process was guided and endorsed by the RIGHT working group and representative international peers,filling the gap in the reporting norms in this field.Finally,the RIGHT-COI&F checklist demonstrated good reliability,validity and feasibility,indicating great potential to promote the completeness and transparency of COI and funding reporting in future guidelines.