Protocol: Assessing the impact of interest-holder engagement on guideline development: A systematic review.

This is the protocol for a Campbell systematic review. The objectives are as follows. The objective of this review is to identify and synthesize empirical research on the impacts of interest-holder engagement on the guideline development process and content. Our research questions are as follows: (1) What are the empirical examples of impact on the process in health guideline development across any of the 18 steps of the GIN-McMaster checklist? (2) What are the empirical examples of impact on the content in health guideline development across any of the 18 steps of the GIN-McMaster checklist?

GRADE guidance 39: using GRADE-ADOLOPMENT to adopt, adapt or create contextualized recommendations from source guidelines and evidence syntheses.

BACKGROUND AND OBJECTIVE: The Grading of Recommendations, Assessment, Development and Evaluations (GRADE)-ADOLOPMENT methodology has been widely used to adopt, adapt, or de novo develop recommendations from existing or new guideline and evidence synthesis efforts. The objective of this guidance is to refine the operationalization for applying GRADE-ADOLOPMENT. METHODS: Through iterative discussions, online meetings, and email communications, the GRADE-ADOLOPMENT project group drafted the updated guidance. We then conducted a review of handbooks of guideline-producing organizations, and a scoping review of published and planned adolopment guideline projects. The lead authors refined the existing approach based on the scoping review findings and feedback from members of the GRADE working group. We presented the revised approach to the group in November 2022 (approximately 115 people), in May 2023 (approximately 100 people), and twice in September 2023 (approximately 60 and 90 people) for approval. RESULTS: This GRADE guidance shows how to effectively and efficiently contextualize recommendations using the GRADE-ADOLOPMENT approach by doing the following: (1) showcasing alternative pathways for starting an adolopment effort; (2) elaborating on the different essential steps of this approach, such as building on existing evidence-to-decision (EtDs), when available or developing new EtDs, if necessary; and (3) providing examples from adolopment case studies to facilitate the application of the approach. We demonstrate how to use contextual evidence to make judgments about EtD criteria, and highlight the importance of making the resulting EtDs available to facilitate adolopment efforts by others. CONCLUSION: This updated GRADE guidance further operationalizes the application of GRADE-ADOLOPMENT based on over 6 years of experience. It serves to support uptake and application by end users interested in contextualizing recommendations to a local setting or specific reality in a short period of time or with limited resources.

Predictors of COVID-19 vaccine acceptability among refugees and other migrant populations: A systematic scoping review.

OBJECTIVE: This study aimed to map the existing literature to identify predictors of COVID-19 vaccine acceptability among refugees, immigrants, and other migrant populations. METHODS: A systematic search of Medline, Embase, Scopus, APA PsycInfo and Cumulative Index of Nursing and Allied Health Literature (CINAHL) was conducted up to 31 January 2023 to identify the relevant English peer-reviewed observational studies. Two independent reviewers screened abstracts, selected studies, and extracted data. RESULTS: We identified 34 cross-sectional studies, primarily conducted in high income countries (76%). Lower vaccine acceptance was associated with mistrust in the host countries' government and healthcare system, concerns about the safety and effectiveness of COVID-19 vaccines, limited knowledge of COVID-19 infection and vaccines, lower COVID-19 risk perception, and lower integration level in the host country. Female gender, younger age, lower education level, and being single were associated with lower vaccine acceptance in most studies. Additionally, sources of information about COVID-19 and vaccines and previous history of COVID-19 infection, also influence vaccine acceptance. Vaccine acceptability towards COVID-19 booster doses and various vaccine brands were not adequately studied. CONCLUSIONS: Vaccine hesitancy and a lack of trust in COVID-19 vaccines have become significant public health concerns within migrant populations. These findings may help in providing information for current and future vaccine outreach strategies among migrant populations.

Mobile apps to reduce depressive symptoms and alcohol use in youth: A systematic review and meta-analysis: A systematic review.

Background: Among youth, symptoms of depression, anxiety, and alcohol use are associated with considerable illness and disability. Youth face many personal and health system barriers in accessing mental health care. Mobile applications (apps) offer youth potentially accessible, scalable, and anonymous therapy and other support. Recent systematic reviews on apps to reduce mental health symptoms among youth have reported uncertain effectiveness, but analyses based on the type of app-delivered therapy are limited. Objectives: We conducted this systematic review with youth co-researchers to ensure that this review addressed the questions that were most important to them. The objective of this review is to synthesize the best available evidence on the effectiveness of mobile apps for the reduction of depressive symptoms (depression, generalized anxiety, psychological distress) and alcohol use among youth. Search Methods: We conducted electronic searches of the following bibliographic databases for studies published between January 1, 2008, and July 1, 2022: MEDLINE (via Ovid), Embase (via Ovid), PsycINFO (via Ovid), CINAHL (via EBSCOHost), and CENTRAL (via the Cochrane Library). The search used a combination of indexed terms, free text words, and MeSH headings. We manually screened the references of relevant systematic reviews and included randomized controlled trials (RCTs) for additional eligible studies, and contacted authors for full reports of identified trial registries or protocols. Selection Criteria: We included RCTs conducted among youth aged 15-24 years from any setting. We did not exclude populations on the basis of gender, socioeconomic status, geographic location or other personal characteristics. We included studies which assessed the effectiveness of app-delivered mental health support or therapy interventions that targeted the management of depressive disorders and/or alcohol use disorders. We excluded apps that targeted general wellness, apps which focused on prevention of psychological disorders and apps that targeted bipolar disorder, psychosis, post-traumatic stress disorder, attention-deficit hyperactivity disorder, substance use disorders (aside from alcohol), and sleep disorders. Eligible comparisons included usual care, no intervention, wait-list control, alternative or controlled mobile applications. We included studies which reported outcomes on depressive symptoms, anxiety symptoms, alcohol use and psychological distress over any follow-up period. Data Collection and Analysis: We standardized the PICO definitions (population, intervention, comparison, and outcome) of each included study and grouped studies by the type of therapy or support offered by the app. Whenever app design and clinical homogeneity allowed, we meta-analyzed outcomes using a random-effects model. Outcome data measured using categorical scales were synthesized using odds ratios. Outcome data measured using continuous scales were synthesized as the standardized mean difference. We assessed the methodological quality of each included study using the Cochrane Risk of Bias 2.0 tool and we assessed certainty of the evidence using the GRADE approach. Main Results: From 5280 unique citations, we included 36 RCTs published in 37 reports and conducted in 15 different countries (7984 participants). Among the 36 included trials, we assessed two with an overall low risk of bias, 8 trials with some concern regarding risk of bias, and 26 trials with a high risk of bias. Interventions varied in the type of therapy or supports offered. The most common intervention designs employed mindfulness training, cognitive behavioral therapy (CBT), or a combination of the two (mindfulness + CBT). However, other interventions also included self-monitoring, medication reminders, cognitive bias modification or positive stimulation, dialectical behavioral therapy, gamified health promotion, or social skill building. Mindfulness apps led to short term improvements in depressive symptoms when compared to a withheld control (SMD = -0.36; 95% CI [-0.63, -0.10]; p = 0.007, n = 3 RCTs, GRADE: very low certainty) and when compared to an active control (SMD = -0.27; 95% CI [-0.53, -0.01]; p = 0.04, n = 2 RCTs, GRADE: very low). Apps delivering this type of support also significantly improved symptoms of anxiety when compared to a withheld control (SMD = -0.35; 95% CI [-0.60, -0.09]; p = 0.008, n = 3 RCTs, GRADE: very low) but not when compared to an active control (SMD = -0.24; 95% CI [-0.50, 0.02]; p = 0.07, n = 2 RCTs, GRADE: very low). Mindfulness apps showed improvements in psychological stress that approached statistical significance among participants receiving the mindfulness mobile apps compared to those in the withheld control (SMD = -0.27; 95% CI [-0.56, 0.03]; p = .07, n = 4 RCTs, GRADE: very low). CBT apps also led to short-term improvements in depressive symptoms when compared to a withheld control (SMD = -0.40; 95% CI [-0.80, 0.01]; p = 0.05, n = 2 RCTs, GRADE: very low) and when compared to an active control (SMD = -0.59; 95% CI [-0.98, -0.19]; p = 0.003, n = 2 RCTs, GRADE: very low). CBT-based apps also improved symptoms of anxiety compared to a withheld control (SMD = -0.51; 95% CI [-0.94, -0.09]; p = 0.02, n = 3 RCTs, GRADE: very low) but not when compared to an active control (SMD = -0.26; 95% CI [-1.11, 0.59]; p = 0.55, n = 3 RCTs, GRADE: very low). Apps which combined mindfulness and CBT did not significantly improve symptoms of depression (SMD = -0.20; 95% CI [-0.42, 0.02]; p = 0.07, n = 2 RCTs, GRADE: very low) or anxiety (SMD = -0.21; 95% CI [-0.49, 0.07]; p = 0.14, n = 2 RCTs, GRADE: very low). However, these apps did improve psychological distress (SMD = -0.43; 95% CI [-0.74, -0.12]; p = 0.006, n = 2 RCTs, GRADE: very low). The results of trials on apps to reduce alcohol use were inconsistent. We did not identify any harms associated with the use of apps to manage mental health concerns. All effectiveness results had a very low certainty of evidence rating using the GRADE approach, meaning that apps which deliver therapy or other mental health support may reduce symptoms of depression, anxiety and psychological distress but the evidence is very uncertain. Authors' Conclusions: We reviewed evidence from 36 trials conducted among youth. According to our meta-analyses, the evidence is very uncertain about the effect of apps on depression, anxiety, psychological distress, and alcohol use. Very few effects were interpreted to be of clinical importance. Most of the RCTs were small studies focusing on efficacy for youth at risk for depressive symptoms. Larger trials are needed to evaluate effectiveness and allow for further analysis of subgroup differences. Longer trials are also needed to better estimate the clinical importance of these apps over the long term.

From struggle to strength in African and Middle Eastern newcomers' integration stories to Canada: A participatory health equity research study.

BACKGROUND AND OBJECTIVES: Newcomers (immigrants, refugees, and international students) face many personal, gender, cultural, environmental and health system barriers when integrating into a new society. These struggles can affect their health and social care, reducing access to mental health care. This study explores the lived experiences of African and Middle Eastern newcomers to Ontario, Canada. An understanding of newcomer integration challenges, successes and social justice issues is needed to improve health equity and social services. METHODS: In this qualitative study, we used a participatory research approach to collect stories reflecting participants' integration perspectives and experiences. Beginning with our immigrant community network, we used snowball sampling to recruit newcomers, ages 18 to 30, originating from Africa or the Middle East. We used qualitative narrative analysis to interpret stories, identifying context themes, integrating related barriers and facilitators, and resolutions and learnings. We shared our findings and sought final feedback from our participants. FINDINGS: A total of 18 newcomers, 78% female and approximately half post-secondary students, participated in the study. Participants described an unknown and intimidating migration context, with periods of loneliness and isolation aggravated by cold winter conditions and unfamiliar language and culture. Amidst the struggles, the support of friends and family, along with engaging in schoolwork, exploring new learning opportunities, and participating in community services, all facilitated integration and forged new resilience. CONCLUSIONS: Community building, friendships, and local services emerged as key elements for future immigrant service research. Utilizing a participatory health research approach allowed us to respond to the call for social justice-oriented research that helps to generate scientific knowledge for promoting culturally adaptive health care and access for marginalized populations.

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.

Operationalizing the GRADE-equity criterion to inform guideline recommendations: application to a medical cannabis guideline.

OBJECTIVES: Incorporating health equity considerations into guideline development often requires information beyond that gathered through traditional evidence synthesis methodology. This article outlines an operationalization plan for the Grading of Recommendations Assessment, Development, and Evaluation (GRADE)-equity criterion to gather and assess evidence from primary studies within systematic reviews, enhancing guideline recommendations to promote equity. We demonstrate its use in a clinical guideline on medical cannabis for chronic pain. STUDY DESIGN AND SETTING: We reviewed GRADE guidance and resources recommended by team members regarding the use of evidence for equity considerations, drafted an operationalization plan, and iteratively refined it through team discussion and feedback and piloted it on a medicinal cannabis guideline. RESULTS: We propose a seven-step approach: 1) identify disadvantaged populations, 2) examine available data for specific populations, 3) evaluate population baseline risk for primary outcomes, 4) assess representation of these populations in primary studies, 5) appraise analyses, 6) note barriers to implementation of effective interventions for these populations, and 7) suggest supportive strategies to facilitate implementation of effective interventions. CONCLUSION: Our approach assists guideline developers in recognizing equity considerations, particularly in resource-constrained settings. Its application across various guideline topics can verify its feasibility and necessary adjustments.

A multimethods randomized trial found that plain language versions improved adults understanding of health recommendations.

OBJECTIVES: To make informed decisions, the general population should have access to accessible and understandable health recommendations. To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of adults provided with a digital "Plain Language Recommendation" (PLR) format vs. the original "Standard Language Version" (SLV). STUDY DESIGN AND SETTING: An allocation-concealed, blinded, controlled superiority trial and a qualitative study to understand participant preferences. An international on-line survey. 488 adults with some English proficiency. 67.8% of participants identified as female, 62.3% were from the Americas, 70.1% identified as white, 32.2% had a bachelor's degree as their highest completed education, and 42% said they were very comfortable reading health information. In collaboration with patient partners, advisors, and the Cochrane Consumer Network, we developed a plain language format of guideline recommendations (PLRs) to compare their effectiveness vs. the original standard language versions (SLVs) as published in the source guideline. We selected two recommendations about COVID-19 vaccine, similar in their content, to compare our versions, one from the World Health Organization (WHO) and one from Centers for Disease Control and Prevention (CDC). The primary outcome was understanding, measured as the proportion of correct responses to seven comprehension questions. Secondary outcomes were accessibility, usability, satisfaction, preference, and intended behavior, measured on a 1-7 scale. RESULTS: Participants randomized to the PLR group had a higher proportion of correct responses to the understanding questions for the WHO recommendation (mean difference [MD] of 19.8%, 95% confidence interval [CI] 14.7-24.9%; P < 0.001) but this difference was smaller and not statistically significant for the CDC recommendation (MD of 3.9%, 95% CI -0.7% to 8.3%; P = 0.096). However, regardless of the recommendation, participants found the PLRs more accessible, (MD of 1.2 on the seven-point scale, 95% CI 0.9-1.4%; P < 0.001) and more satisfying (MD of 1.2, 95% CI 0.9-1.4%; P < 0.001). They were also more likely to follow the recommendation if they had not already followed it (MD of 1.2, 95% CI 0.7-1.8%; P < 0.001) and share it with other people they know (MD of 1.9, 95% CI 0.5-1.2%; P < 0.001). There was no significant difference in the preference between the two formats (MD of -0.3, 95% CI -0.5% to 0.03%; P = 0.078). The qualitative interviews supported and contextualized these findings. CONCLUSION: Health information provided in a PLR format improved understanding, accessibility, usability, and satisfaction and thereby has the potential to shape public decision-making behavior.

Protocol for the development of guidance for collaborator and partner engagement in health care evidence syntheses.

BACKGROUND: Involving collaborators and partners in research may increase relevance and uptake, while reducing health and social inequities. Collaborators and partners include people and groups interested in health research: health care providers, patients and caregivers, payers of health research, payers of health services, publishers, policymakers, researchers, product makers, program managers, and the public. Evidence syntheses inform decisions about health care services, treatments, and practice, which ultimately affect health outcomes. Our objectives are to: A. Identify, map, and synthesize qualitative and quantitative findings related to engagement in evidence syntheses B. Explore how engagement in evidence synthesis promotes health equity C. Develop equity-oriented guidance on methods for conducting, evaluating, and reporting engagement in evidence syntheses METHODS: Our diverse, international team will develop guidance for engagement with collaborators and partners throughout multiple sequential steps using an integrated knowledge translation approach: 1. Reviews. We will co-produce 1 scoping review, 3 systematic reviews and 1 evidence map focusing on (a) methods, (b) barriers and facilitators, (c) conflict of interest considerations, (d) impacts, and (e) equity considerations of engagement in evidence synthesis. 2. Methods study, interviews, and survey. We will contextualise the findings of step 1 by assessing a sample of evidence syntheses reporting on engagement with collaborators and partners and through conducting interviews with collaborators and partners who have been involved in producing evidence syntheses. We will use these findings to develop draft guidance checklists and will assess agreement with each item through an international survey. 3. CONSENSUS: The guidance checklists will be co-produced and finalised at a consensus meeting with collaborators and partners. 4. DISSEMINATION: We will develop a dissemination plan with our collaborators and partners and work collaboratively to improve adoption of our guidance by key organizations. CONCLUSION: Our international team will develop guidance for collaborator and partner engagement in health care evidence syntheses. Incorporating partnership values and expectations may result in better uptake, potentially reducing health inequities.

Equity issues rarely addressed in the development of COVID-19 formal recommendations and good practice statements: a cross-sectional study.

BACKGROUND AND OBJECTIVE: To identify COVID-19 actionable statements (e.g., recommendations) focused on specific disadvantaged populations in the living map of COVID-19 recommendations (eCOVIDRecMap) and describe how health equity was assessed in the development of the formal recommendations. METHODS: We employed the place of residence, race or ethnicity or culture, occupation, gender or sex, religion, education, socio-economic status, and social capital-Plus framework to identify statements focused on specific disadvantaged populations. We assessed health equity considerations in the evidence to decision frameworks (EtD) of formal recommendations for certainty of evidence and impact on health equity criteria according to the Grading of Recommendations, Assessment, Development, and Evaluations criteria. RESULTS: We identified 16% (124/758) formal recommendations and 24% (186/819) good practice statements (GPS) that were focused on specific disadvantaged populations. Formal recommendations (40%, 50/124) and GPS (25%, 47/186) most frequently focused on children. Seventy-six percent (94/124) of the recommendations were accompanied with EtDs. Over half (55%, 52/94) of those considered indirectness of the evidence for disadvantaged populations. Considerations in impact on health equity criterion most frequently involved implementation of the recommendation for disadvantaged populations (17%, 16/94). CONCLUSION: Equity issues were rarely explicitly considered in the development COVID-19 formal recommendations focused on specific disadvantaged populations. Guidance is needed to support the consideration of health equity in guideline development during health emergencies.

Plain Language vs Standard Format for Youth Understanding of COVID-19 Recommendations: A Randomized Clinical Trial.

Importance: To ensure that youths can make informed decisions about their health, it is important that health recommendations be presented for understanding by youths. Objective: To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of youths provided with a digital plain language recommendation (PLR) format vs the original standard language version (SLV) of a health recommendation. Design, Setting, and Participants: This pragmatic, allocation-concealed, blinded, superiority randomized clinical trial included individuals from any country who were 15 to 24 years of age, had internet access, and could read and understand English. The trial was conducted from May 27 to July 6, 2022, and included a qualitative component. Interventions: An online platform was used to randomize youths in a 1:1 ratio to an optimized digital PLR or SLV format of 1 of 2 health recommendations related to the COVID-19 vaccine; youth-friendly PLRs were developed in collaboration with youth partners and advisors. Main Outcomes and Measures: The primary outcome was understanding, measured as the proportion of correct responses to 7 comprehension questions. Secondary outcomes were accessibility, usability, satisfaction, preference, and intended behavior. After completion of the survey, participants indicated their interest in completing a 1-on-1 semistructured interview to reflect on their preferred digital format (PLR or SLV) and their outcome assessment survey response. Results: Of the 268 participants included in the final analysis, 137 were in the PLR group (48.4% female) and 131 were in the SLV group (53.4% female). Most participants (233 [86.9%]) were from North and South America. No significant difference was found in understanding scores between the PLR and SLV groups (mean difference, 5.2%; 95% CI, -1.2% to 11.6%; P = .11). Participants found the PLR to be more accessible and usable (mean difference, 0.34; 95% CI, 0.05-0.63) and satisfying (mean difference, 0.39; 95% CI, 0.06-0.73) and had a stronger preference toward the PLR (mean difference, 4.8; 95% CI, 4.5-5.1 [4.0 indicated a neutral response]) compared with the SLV. No significant difference was found in intended behavior (mean difference, 0.22 (95% CI, -0.20 to 0.74). Interviewees (n = 14) agreed that the PLR was easier to understand and generated constructive feedback to further improve the digital PLR. Conclusions and Relevance: In this randomized clinical trial, compared with the SLV, the PLR did not produce statistically significant findings in terms of understanding scores. Youths ranked it higher in terms of accessibility, usability, and satisfaction, suggesting that the PLR may be preferred for communicating health recommendations to youths. The interviews provided suggestions for further improving PLR formats. Trial Registration: ClinicalTrials.gov Identifier: NCT05358990.

A multimethods randomized trial found that plain language versions improved parents' understanding of health recommendations.

OBJECTIVES: To assess the effectiveness of plain language compared with standard language versions of COVID-19 recommendations specific to child health. STUDY DESIGN AND SETTING: Pragmatic, allocation-concealed, blinded, superiority randomized controlled trial with nested qualitative component. Trial was conducted online, internationally. Parents or legal guardians (≥18 years) of a child (<18 years) were eligible. Participants were randomized to receive a plain language recommendation (PLR) or standard (SLV) verison of a COVID-19 recommendation specific to child health. Primary outcome was understanding. Secondary outcomes included: preference, accessibility, usability, satisfaction, and intended behavior. Interviews explored perceptions and preferences for each format. RESULTS: Between July and August 2022, 295 parents were randomized; 241 (81.7%) completed the study (intervention n = 121, control n = 120). Mean understanding scores were significantly different between groups (PLR 3.96 [standard deviation (SD) 2.02], SLV 3.33 [SD 1.88], P = 0.014). Overall participants preferred the PLR version: mean rating 5.05/7.00 (95% CI 4.81, 5.29). Interviews (n = 12 parents) highlighted their preference for the PLR and provided insight on elements to enhance future knowledge mobilization of health recommendations. CONCLUSION: Compared to SLVs, parents preferred PLRs and better understood the recommendation. Guideline developers should strive to use plain language to increase understanding, uptake, and implementation of evidence by the public.

Realist review of community coalitions and outreach interventions to increase access to primary care for vulnerable populations: a realist review.

BACKGROUND: There are meaningful gaps in equitable access to Primary Health Care (PHC), especially for vulnerable populations after widespread reforms in Western countries. The Innovative Models Promoting Access-to-Care Transformation (IMPACT) research program is a Canadian-Australian collaboration that aims to improve access to PHC for vulnerable populations. Relationships were developed with stakeholders in six regions across Canada and Australia where access-related needs could be identified. The most promising interventions would be implemented and tested to address the needs identified. This realist review was conducted to understand how community coalition and outreach (e.g., mobile or pop-up) services improve access for underserved vulnerable residents. OBJECTIVE: To inform the development and delivery of an innovative intervention to increase access to PHC for vulnerable populations. METHODS: A realist review was conducted in collaboration with the Local Innovative Partnership (LIP) research team and the IMPACT research members who conducted the review. We performed an initial comprehensive systematic search using MEDLINE, EMBASE, PsycINFO, and the Cochrane Library up to October 19, 2015, and updated it on August 8, 2020. Studies were included if they focused on interventions to improve access to PHC using community coalition, outreach services or mobile delivery methods. We included Randomized Controlled Trials (RCTs), and systematic reviews. Studies were screened by two independent reviewers and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was used for data extraction and framework analysis to obtain themes. The LIP research team was also allowed to suggest additional papers not included at screening. RESULTS: We included 43 records, comprising 31 RCTs, 11 systematic reviews, and 1 case control study that was added by the LIP research team. We identified three main themes of PHC interventions to promote access for vulnerable residents, including: 1) tailoring of materials and services decreases barriers to primary health care, 2) services offered where vulnerable populations gather increases the "reach" of the interventions, 3) partnerships and collaborations lead to positive health outcomes. In addition, implementation designs and reporting elements should be considered. CONCLUSION: Realist reviews can help guide the development of locally adapted primary health care interventions.

Vaccines for all: A formative evaluation of a multistakeholder community-engaged COVID-19 vaccine outreach clinic for migrant communities.

Background: Racialized, low-income, and migrant populations experience persistent barriers to vaccines against COVID-19. These communities in East and Northeast Calgary were disproportionately impacted by COVID-19, yet faced vaccine access barriers. Diverse multi-stakeholder coalitions and community partnerships can improve vaccine outreach strategies, but how stakeholders perceive these models is unknown. Methods: We conducted a formative evaluation of a low-barrier, community-engaged vaccine outreach clinic in Calgary, Alberta, Canada, on June 5-6, 2021. We delivered an online post-clinic survey to clinic stakeholders, to assess whether the clinic achieved its collectively derived pre-specified goals (effective, efficient, patient-centered, and safe), to asses whether the clinic model was scalable, and to solicit improvement recommendations. Survey responses were analyzed using descriptive statistics and thematic analysis. Results: Overall, 166/195 (85%) stakeholders responded. The majority were from non-healthcare positions (59%), between 30 and 49 years of age (87/136; 64%), and self-identified as racialized individuals (96/136; 71%). Respondents felt the clinic was effective (99.2%), efficient (96.9%), patient-centered (92.3%), and safe (90.8%), and that the outreach model was scalable 94.6% (123/130). There were no differences across stakeholder categories. The open-ended survey responses supported the scale responses. Improvement suggestions describe increased time for clinic planning and promotion, more multilingual staff, and further efforts to reduce accessibility barriers, such as priority check-in for people with disabilities. Conclusion: Diverse stakeholders almost universally felt that this community-engaged COVID-19 vaccine outreach clinic achieved its goals and was scalable. These findings support the value of community-engaged outreach to improve vaccine equity among other marginalized newcomer communities.

Key issues for stakeholder engagement in the development of health and healthcare guidelines.

Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development.

A group of international researchers, patient partners, and other stakeholders are working together to create a checklist for when and how to involve stakeholders in health guideline development. Health guidelines include clinical practice guidelines, which your healthcare provider uses to determine treatments for health conditions. While working on this checklist, the team identified key issues to work on, including: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. This paper describes each issue and how the team plans to produce guidance papers to address them.

Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.

BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies.

INTRODUCTION: The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public's understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (RecMap). METHODS AND ANALYSIS: This is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and youth, with at least 240 participants in each population. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. The intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (standard language version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the recommendation formats. Each population's results will be analyzed separately. However, we are planning a meta-analysis of the results across populations. At the end of each survey, participants will be invited to participate in an optional one-on-one, virtual semi-structured interview to explore their user experience. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. ETHICS AND DISSEMINATION: Through Clinical Trials Ontario, the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). Findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media. TRIAL REGISTRATION: Clinicaltrials.gov NCT05358990 . Registered on May 3, 2022.

Good or best practice statements: proposal for the operationalisation and implementation of GRADE guidance.

An evidence-based approach is considered the gold standard for health decision-making. Sometimes, a guideline panel might judge the certainty that the desirable effects of an intervention clearly outweigh its undesirable effects as high, but the body of supportive evidence is indirect. In such cases, the application of the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach for grading the strength of recommendations is inappropriate. Instead, the GRADE Working Group has recommended developing ungraded best or good practice statement (GPS) and developed guidance under which circumsances they would be appropriate.Through an evaluation of COVID-1- related recommendations on the eCOVID Recommendation Map (COVID-19.recmap.org), we found that recommendations qualifying a GPS were widespread. However, guideline developers failed to label them as GPS or transparently report justifications for their development. We identified ways to improve and facilitate the operationalisation and implementation of the GRADE guidance for GPS.Herein, we propose a structured process for the development of GPSs that includes applying a sequential order for the GRADE guidance for developing GPS. This operationalisation considers relevant evidence-to-decision criteria when assessing the net consequences of implementing the statement, and reporting information supporting judgments for each criterion. We also propose a standardised table to facilitate the identification of GPS and reporting of their development. This operationalised guidance, if endorsed by guideline developers, may palliate some of the shortcomings identified. Our proposal may also inform future updates of the GRADE guidance for GPS.

Identifying Health Equity Factors That Influence the Public's Perception of COVID-19 Health Information and Recommendations: A Scoping Review.

The COVID-19 pandemic has impacted global public health and public trust in health recommendations. Trust in health information may waver in the context of health inequities. The objective of this scoping review is to map evidence on public perceptions of COVID-19 prevention information using the PROGRESS-Plus health equity framework. We systematically searched the MEDLINE, Cochrane Central Register of Controlled Trials, PsycInfo, and Embase databases from January 2020 to July 2021. We identified 792 citations and 31 studies published in 15 countries that met all inclusion criteria. The majority (30/31; 96.7%) of the studies used an observational design (74.2% cross-sectional, 16.1% cohort, 6.5% case study, 3.2% experimental trials). Most studies (61.3%) reported on perception, understanding, and uptake, and 35.5% reported on engagement, compliance, and adherence to COVID-19 measures. The most frequently reported sources of COVID-related information were social media, TV, news (newspapers/news websites), and government sources. We identified five important equity factors related to public trust and uptake of recommendations: education and health literacy (19 studies; 61.3%), gender (15 studies; 48.4%), age (15 studies; 48.4%), socioeconomic status (11 studies; 35.5%), and place of residence (10 studies; 32.3%). Our review suggests that equity factors play a role in public perception of COVID-19 information and recommendations. A future systematic review could be conducted to estimate the impact of equity factors on perception and behavior outcomes.