Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation

Stakeholder 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. METHODS: This 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. DISCUSSION: We 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 We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders.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

Factors to Consider During Identification and Invitation of Individuals in a Multi-stakeholder Research Partnership

BACKGROUND: Health research teams increasingly partner with stakeholders to produce research that is relevant, accessible, and widely used. Previous work has covered stakeholder group identification. OBJECTIVE: We aimed to develop factors for health research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership, with the aim of forming equitable and informed teams. DESIGN: Consensus development. PARTICIPANTS: We involved 16 stakeholders from the international Multi-Stakeholder Engagement (MuSE) Consortium, including patients and the public, providers, payers of health services/purchasers, policy makers, programme managers, peer review editors, and principal investigators. APPROACH: We engaged stakeholders in factor development and as co-authors of this manuscript. Using a modified Delphi approach, we gathered stakeholder views concerning a preliminary list of 18 factors. Over two feedback rounds, using qualitative and quantitative analysis, we concentrated these into ten factors. KEY RESULTS: We present seven highly desirable factors: ‘expertise or experience’, ‘ability and willingness to represent the stakeholder group’, ‘inclusivity (equity, diversity and intersectionality)’, ‘communication skills’, ‘commitment and time capacity’, ‘financial and non-financial relationships and activities, and conflict of interest’, ‘training support and funding needs’. Additionally, three factors are desirable: ‘influence’, ‘research relevant values’, ‘previous stakeholder engagement’. CONCLUSIONS: We present factors for research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership. Policy makers and guideline developers may benefit from considering the factors in stakeholder identification and invitation. Research funders may consider stipulating consideration of the factors in funding applications. We outline how these factors can be implemented and exemplify how their use has the potential to improve the quality and relevancy of health research. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-022-07411-w

Improving Social Justice in COVID-19 Health Research: Interim guidelines for reporting health equity in observational studies

The COVID-19 pandemic has highlighted the global imperative to address health inequities. Observational studies are a valuable source of evidence for real-world effects and impacts of implementing COVID-19 policies on the redistribution of inequities. We assembled a diverse global multi-disciplinary team to develop interim guidance for improving transparency in reporting health equity in COVID-19 observational studies. We identified 14 areas in the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist that need additional detail to encourage transparent reporting of health equity. We searched for examples of COVID-19 observational studies that analysed and reported health equity analysis across one or more social determinants of health. We engaged with Indigenous stakeholders and others groups experiencing health inequities to co-produce this guidance and to bring an intersectional lens. Taking health equity and social determinants of health into account contributes to the clinical and epidemiological understanding of the disease, identifying specific needs and supporting decision-making processes. Stakeholders are encouraged to consider using this guidance on observational research to help provide evidence to close the inequitable gaps in health outcomes

Impulsiveness, postprandial blood glucose and glucoregulation affect measures of behavioral flexibility

Behavioral flexibility (BF) performance is influenced by both psychological and physiological factors. Recent evidence suggests that impulsivity and blood glucose can affect executive function, of which BF is a subdomain. Here, we hypothesized that impulsivity, fasting blood glucose (FBG), glucose changes (i.e. glucoregulation) from postprandial blood glucose (PBG) following the intake of a 15g glucose beverage could account for variability in BF performance. The Stroop Color-Word Test and the Wisconsin Card Sorting Test (WCST) were used as measures of BF, and the Barratt Impulsiveness Scale (BIS-11) to quantify participants’ impulsivity. In Study 1, neither impulsivity nor FBG could predict performance on the Stroop or the WCST. In Study 2, we tested whether blood glucose levels following the intake of a sugary drink, and absolute changes in glucose levels following the intake of the glucose beverage could better predict BF. Results showed that impulsivity and the difference in blood glucose between time 1 (postprandial) and time 2, but not blood glucose levels at time 2 per se could account for variation in performance on the WCST but not on the Stroop task. More specifically, lower impulsivity scores on the BIS-11, and smaller differences in blood glucose levels from time 1 to time 2 predicted a decrease in the number of total and perseverative errors on the WCST. Our results show that measures of impulsivity and glucoregulation can be used to predict BF. Importantly our data extend the work on glucose and cognition to a clinically relevant domain of cognition

Reporting of equity in observational epidemiology: a methodological review

Background Observational studies can inform how we understand and address persisting health inequities through the collection, reporting and analysis of health equity factors. However, the extent to which the analysis and reporting of equity-relevant aspects in observational research are generally unknown. Thus, we aimed to systematically evaluate how equity-relevant observational studies reported equity considerations in the study design and analyses. Methods We searched MEDLINE for health equity-relevant observational studies from January 2020 to March 2022, resulting in 16 828 articles. We randomly selected 320 studies, ensuring a balance in focus on populations experiencing inequities, country income settings, and coronavirus disease 2019 (COVID-19) topic. We extracted information on study design and analysis methods. Results The bulk of the studies were conducted in North America (n = 95, 30%), followed by Europe and Central Asia (n = 55, 17%). Half of the studies (n = 171, 53%) addressed general health and well-being, while 49 (15%) focused on mental health conditions. Two-thirds of the studies (n = 220, 69%) were cross-sectional. Eight (3%) engaged with populations experiencing inequities, while 22 (29%) adapted recruitment methods to reach these populations. Further, 67 studies (21%) examined interaction effects primarily related to race or ethnicity (48%). Two-thirds of the studies (72%) adjusted for characteristics associated with inequities, and 18 studies (6%) used flow diagrams to depict how populations experiencing inequities progressed throughout the studies. Conclusions Despite over 80% of the equity-focused observational studies providing a rationale for a focus on health equity, reporting of study design features relevant to health equity ranged from 0–95%, with over half of the items reported by less than one-quarter of studies. This methodological study is a baseline assessment to inform the development of an equity-focussed reporting guideline for observational studies as an extension of the well-known Strengthening Reporting of Observational Studies in Epidemiology (STROBE) guideline

Considerations and guidance in designing equity-relevant clinical trials

Abstract Health research has documented disparities in health and health outcomes within and between populations. When these disparities are unfair and avoidable they may be referred to as health inequities. Few trials attend to factors related to health inequities, and there is limited understanding about how to build consideration of health inequities into trials. Due consideration of health inequities is important to inform the design, conduct and reporting of trials so that research can build evidence to more effectively address health inequities and importantly, ensure that inequities are not aggravated. In this paper, we discuss approaches to integrating health equity-considerations in randomized trials by using the PROGRESS Plus framework (Place of residence, Race/ethnicity/culture/language, Occupation, Gender, Religion, Education, Socio-economic status, Social capital and “Plus” that includes other context specific factors) and cover: (i) formulation of research questions, (ii) two specific scenarios relevant to trials about health equity and (iii) describe how the PROGRESS Plus characteristics may influence trial design, conduct and analyses. This guidance is intended to support trialists designing equity-relevant trials and lead to better design, conduct, analyses and reporting, by addressing two main issues: how to avoid aggravating inequity among research participants and how to produce information that is useful to decision-makers who are concerned with health inequities

Motivations for investigating health inequities in observational epidemiology: A content analysis of 320 studies

Objectives: To enhance equity in clinical and epidemiological research, it is crucial to understand researcher motivations for conducting equity-relevant studies. Therefore, we evaluated author motivations in a randomly selected sample of equity-relevant observational studies published during the COVID-19 pandemic.Study design and setting: We searched MEDLINE for studies from 2020 to 2022, resulting in 16,828 references. We randomly selected 320 studies purposefully sampled across income setting (high vs low-middle-income), COVID-19 topic (vs non-COVID-19), and focus on populations experiencing inequities. Of those, 206 explicitly mentioned motivations which we analyzed thematically. We used discourse analysis to investigate the reasons behind emerging motivations.Results: We identified the following motivations: (1) examining health disparities, (2) tackling social determinants to improve access, and (3) addressing knowledge gaps in health equity. Discourse analysis showed motivations stem from commitments to social justice and recognizing the importance of highlighting it in research. Other discourses included aspiring to improve health-care efficiency, wanting to understand cause-effect relationships, and seeking to contribute to an equitable evidence base.Conclusion: Understanding researchers\u27 motivations for assessing health equity can aid in developing guidance that tailors to their needs. We will consider these motivations in developing and sharing equity guidance to better meet researchers\u27 needs

Proceedings of the 2017 Advancing the Science of Community Engaged Research (CEnR) Conference

Abstract Background To address an urgent need to advance the field of community engaged research, faculty at Vanderbilt University Medical Center and Meharry Medical College organized the national meeting "Advancing the Science of Community Engaged Research (CEnR): Innovative & Effective Methods of Stakeholder Engagement in Translational Research, Washington, DC September 14-15, 2017 (See Additional file 1). These meetings brought together a diverse group of stakeholders to share community engaged research evidence and practical knowledge for implementing new and enhancing existing research programs. The conference series’ goals were: 1) to expand the scientific basis for the community engaged research field by convening researchers, community partners, patient advocacy organizations, and others to share innovative methods and strategies; 2) to engage community representatives and patient advocates in the development of new approaches in community engaged research by meaningfully involving them in the planning, as speakers and presenters, and as conference participants; and 3) to catalyze innovative community engaged research using interactive meeting methods that promote learning, support collective problem solving, and encourage new conceptual frameworks. These conferences have advanced community engagement across the translational research spectrum in biomedical research. For the 2017 meeting, described here, the overarching theme was Innovative and Effective Methods of Stakeholder Engagement in Translational Research. Methods The forum was attended by over 210 participants. This conference used novel approaches to fulfill its objectives of participant diversity, meaningful stakeholder engagement, and eliciting varied distinct perspectives to advance the science of community engaged research. Innovative strategies for the conference included: Think Tanks focused on emerging community engaged research topics or topics in need of urgent attention. These dynamic group sessions provided for freely sharing ideas with the purpose of creating change and facilitating new research collaborations. Learning Labs offered unique opportunities to gain practical knowledge regarding innovative methods in community engaged research. Learning Labs also facilitated the wide broadcast of locally successful engagement methods with the goal of speeding the uptake and implementation of community engaged methods. Travel Scholarships were provided for twenty community and patient representatives to participate in the conference. The lack of travel funds was a significant barrier to stakeholder participation in prior community engaged research meetings. The scholarships expanded the role of community and patient representatives in setting research priorities and promoting methods development. Meaningful Engagement meant that community members and patients participated in decision making on all aspects of the conference planning, including the selection of themes, topics, and speakers, and were fully integrated into the conference as speakers, panelists, and moderators. Conclusions Community and stakeholder engagement can directly impact research by enhancing clinical trial design, increasing relevance, and increasing recruitment, accrual and retention (Staley K.: Exploring Impact: Public 53 Involvement in NHS, Public Health and Social Care Research – INVOLVE.; 2009, Johnson et al Clin Transl Sci 8:388-54 390, 2015, Joosten et al Acad Med 90:1646-1650, 2015). The 2017 Advancing the Science of Community Engaged Research meeting, Innovative and Effective Methods of Stakeholder Engagement in Translational Research facilitated meaningful engagement of diverse stakeholder groups including racial and ethnic minorities, community and patient representatives, and junior investigators. Of 210 attendees, 72 completed the evaluation, and, of those, 36% self-affiliated as community members, and 21% as patient/caregiver advocacy, faith-based, or tribal organization members. This conference 1) represented a step toward expanding the scientific basis for the community engaged research (CEnR) field; 2) catalyzed innovative community engaged research; and 3) enhanced the reach and impact of the scientific developments emerging from pioneering work in community engagement

Development of an extension of the OMERACT Summary of Measurement Properties table to capture equity considerations: SOMP-Equity.

From PubMed via Jisc Publications RouterHistory: received 2021-05-01, revised 2021-09-17, accepted 2021-09-20Publication status: aheadofprintTo develop an equity extension of the OMERACT Summary of Measurement Properties (SOMP) Table, SOMP Equity to describe whether a patient reported outcome measure (PROM) works well among patients of diverse languages and cultures, education levels, and other population characteristics. We used the PROGRESS-Plus framework to categorize equity characteristics assessed in trials of PROM. PROGRESS refers to Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social Capital, while the 'plus' captures additional characteristics, such as age. We pilot tested our SOMP Equity Extension using the Health Assessment Questionnaire (HAQ) as a prototypical PROM. The SOMP Equity Extension retains the same columns as the original OMERACT SOMP (domain match, feasibility, construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, thresholds of meaning) but uses the PROGRESS-Plus characteristics as rows. We found several examples of studies of the HAQ which had assessed one or more PROGRESS-Plus characteristics. The most commonly reported equity considerations were related to language. OMERACT Equity virtual meeting participants were polled and they indicated that the SOMP Equity Extension is useful for highlighting and tracking equity considerations for OMERACT Core Outcome Measurement Instruments. [Abstract copyright: Copyright © 2021. Published by Elsevier Inc.