PROTOCOL: Conflict of interest issues when engaging stakeholders in health and healthcare guideline development: a systematic review.
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SUBMITTER: Khabsa J
PROVIDER: S-EPMC9013401 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature
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PROTOCOL: Conflict of interest issues when engaging stakeholders in health and healthcare guideline development: a systematic review.
Khabsa Joanne J Petkovic Jennifer J Riddle Alison A Lytvyn Lyubov L Magwood Olivia O Atwere Pearl P Campbell Pauline P Katikireddi Srinivasa V SV Merner Bronwen B Nasser Mona M Chang Stephanie S Jaramillo Garcia Alejandra A Limburg Heather H Guise Jeanne-Marie JM Tugwell Peter P Akl Elie A EA
Campbell systematic reviews 20220416 2
This is the protocol for a Campbell systematic review. The overall objective of this study is to gather and summarize the existing literature on conflict of interest issues when engaging stakeholders in guideline development. ...[more]
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Project description:BackgroundThere 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 findingsWe 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/significanceThere 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.
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Project description:Objective: To identify processes to engage stakeholders in healthcare Simulation Modeling (SM), and the impacts of this engagement on model design, model implementation, and stakeholder participants. To investigate how engagement process may lead to specific impacts. Data Sources: English-language articles on health SM engaging stakeholders in the MEDLINE, EMBASE, Scopus, Web of Science and Business Source Complete databases published from inception to February 2020. Study Design: A systematic review of the literature based on a priori protocol and reported according to PRISMA guidelines. Extraction Methods: Eligible articles were SM studies with a health outcome which engaged stakeholders in model design. Data were extracted using a data extraction form adapted to be specific for stakeholder engagement in SM studies. Data were analyzed using summary statistics, deductive and inductive content analysis, and narrative synthesis. Principal Findings: Thirty-two articles met inclusion criteria. Processes used to engage stakeholders in healthcare SM are heterogenous and often based on intuition rather than clear methodological frameworks. These processes most commonly involve stakeholders across multiple SM stages via discussion/dialogue, interviews, workshops and meetings. Key reported impacts of stakeholder engagement included improved model quality/accuracy, implementation, and stakeholder decision-making. However, for all but four studies, these reports represented author perceptions rather than formal evaluations incorporating stakeholder perspectives. Possible process enablers of impact included the use of models as "boundary objects" and structured facilitation via storytelling to promote effective communication and mutual understanding between stakeholders and modelers. Conclusions: There is a large gap in the current literature of formal evaluation of SM stakeholder engagement, and a lack of consensus about the processes required for effective SM stakeholder engagement. The adoption and clear reporting of structured engagement and process evaluation methodologies/frameworks are required to advance the field and produce evidence of impact.
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Project description:BackgroundClinical practice guidelines for the management of complex chronic conditions in older adults encourage healthcare providers to engage patients in shared decision-making about self-management goals and actions. Yet, healthcare decision-making and communication for this population can pose significant challenges. As a result, healthcare professionals may struggle to help patients define and prioritise their values, goals, and preferences in ways that are clinically and personally meaningful, incorporating physical functioning and quality of life, when faced with numerous diagnostic and treatment alternatives. The aim of this systematic review is to locate and synthesise a body of fine-grained observational research on communication between professionals, older adults, and carers regarding self-management in audio/audio-visually recorded naturalistic interactions.Methods/designThe paper describes a systematic review of the published conversation analytic and discourse analytic research, using an aggregative thematic approach and following the PRISMA-P guidelines. This review will include studies reporting on adult patients (female or male) aged ≥ 60 years whose consultations are conducted in English in any healthcare setting and stakeholders involved in their care, e.g. general practitioners, nurses, allied health professionals, and family carers. We will search nine electronic databases and the grey literature and two independent reviewers will screen titles and abstracts to identify potential studies. Discrepancies will be resolved via consultation with the review team. The methodological quality of the final set of included studies will be appraised using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research and a detailed description of the characteristics of the included studies using a customised template.DiscussionThis is the first systematic review to date to locate and synthesise the conversation analytic research on how healthcare professionals raise and pursue talk about self-management with older adults in routine clinical interactions. Amalgamating these findings will enable the identification of effective and potentially trainable communication practices for engaging older adults in healthcare decision-making about the self-management goals and actions that enable the greatest possible health and quality of life in older adulthood.Systematic review registrationPROSPERO CRD42019139376.
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Project description:BackgroundFunding bodies increasingly require researchers to write lay summaries to communicate projects' real-world relevance to the public in an accessible way. However, research proposals and findings are generally not easily readable or understandable by non-specialist readers. Many researchers find writing lay summaries difficult because they typically write for fellow subject specialists or academics rather than the general public or a non-specialist audience. The primary objective of our project is to develop guidelines for researchers in Canada's AGE-WELL Network of Centres of Excellence, and ultimately various other disciplines, sectors, and institutions, to co-create lay summaries of research projects with stakeholders. To begin, we produced a protocol for co-creating a lay summary based on workshops we organized and facilitated for an AGE-WELL researcher. This paper presents the lay summary co-creation protocol that AGE-WELL researchers will be invited to use.MethodsEligible participants in this project will be 24 AgeTech project researchers who are funded by the AGE-WELL network in its Core Research Program 2020. If they agree to participate in this project, we will invite them to use our protocol to co-produce a lay summary of their respective projects with stakeholders. The protocol comprises six steps: Investigate principles of writing a good lay summary, identify the target readership, identify stakeholders to collaborate with, recruit the identified stakeholders to work on a lay summary, prepare for workshop sessions, and execute the sessions. To help participants through the process, we will provide them with a guide to developing an accessible, readable research lay summary, help them make decisions, and host, and facilitate if needed, their lay summary co-creation workshops.DiscussionPublic-facing research outputs, including lay summaries, are increasingly important knowledge translation strategies to promote the impact of research on real-world issues. To produce lay summaries that include information that will interest a non-specialist readership and that are written in accessible language, stakeholder engagement is key. Furthermore, both researchers and stakeholders benefit by participating in the co-creation process. We hope the protocol helps researchers collaborate with stakeholders effectively to co-produce lay summaries that meet the needs of both the public and project funders.
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Project description:Background:Patient engagement is a key quality component of cancer guideline development; however, the optimal strategy for engaging patients in guideline development remains unclear. The feasibility and efficacy of two patient engagement models was tested by Cancer Care Ontario's cancer guideline development program, the Program in Evidence-Based Care (pebc). Methods:In model 1, patients participated in the guideline development process as active members of a working group. In model 2, patients formed a separate consultation group to review project plans and recommendations generated by multiple working groups. Training included online resources (model 1) and an in-person orientation (model 2). The pebc's standard patient engagement process acted as a control. The study was conducted for 1 year. Surveys measured the satisfaction of patients and members of the guideline working groups with the process and the outcome of each model. Results:Three guideline projects used model 1 to engage patients, six projects used model 2 to receive feedback, and one project was used as a control group (14 patients total). Most participants, whatever the model, reported satisfaction with their experience. Key challenges to implementation included patient recruitment and long wait times between meetings (model 1), and difficulty focusing on the discussion topic and poor meeting attendance on the part of patients (model 2). Conclusions:The pilot study demonstrated that, although both models are feasible and effective for the engagement of patients in cancer guideline development, modifications are required to optimize their continued interest. The pebc will use the study results to inform the implementation of a patient engagement strategy for its program.
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Project description:This is the protocol for a Campbell systematic review. The objectives are as follows: to identify, describe, and summarize existing guidance and methods for multistakeholder engagement throughout the health guideline development process.
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Project description:BackgroundStakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation.MethodsThis will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation.DiscussionWe will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health.
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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.
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