"We are not invited": Australian focus group results on how to improve ethnic diversity in trials.

OBJECTIVES: Lack of ethnic diversity in trials may contribute to health disparities and to inequity in health outcomes. The primary objective was to investigate the experiences and perspectives of ethnically diverse populations about how to improve ethnic diversity in trials. STUDY DESIGN AND SETTING: Qualitative data were collected via 16 focus groups with participants from 21 ethnically diverse communities in Australia. Data collection took place between August and September 2022 in community-based settings in six capital cities: Sydney, Melbourne, Perth, Adelaide, Brisbane, and Darwin, and one rural town: Bordertown (South Australia). RESULTS: One hundred and fifty-eight purposively sampled adults (aged 18-85, 49% women) participated in groups speaking Tamil, Greek, Punjabi, Italian, Mandarin, Cantonese, Karin, Vietnamese, Nepalese, and Arabic; or English-language groups (comprising Fijian, Filipino, African, and two multicultural groups). Only 10 participants had previously taken part in medical research including three in trials. There was support for medical research, including trials; however, most participants had never been invited to participate. To increase ethnic diversity in trial populations, participants recommended recruitment via partnering with communities, translating trial materials and making them culturally accessible using audiovisual ways, promoting retention by minimizing participant burden, establishing trust and rapport between participants and researchers, and sharing individual results. Participants were reluctant to join studies on taboo topics in their communities (eg, sexual health) or in which physical specimens (eg, blood) were needed. Participants said these barriers could be mitigated by communicating about the topic in more culturally cognizant and safe ways, explaining how data would be securely stored, and reinforcing the benefit of medical research to humanity. CONCLUSION: Participants recognized the principal benefits of trials and other medical research, were prepared to take part, and offered suggestions on recruitment, consent, data collection mechanisms, and retention to enable this to occur. Researchers should consider these community insights when designing and conducting trials; and government, regulators, funders, and publishers should allow for greater innovation and flexibility in their processes to enable ethnic diversity in trials to improve.

Building evidence to advance health equity: a systematic review on care-related outcomes for older, minoritised populations in long-term care homes.

BACKGROUND: Advancing health equity requires more contextualised evidence. OBJECTIVES: To synthesise published evidence using an existing framework on the origins of health disparities and determine care-related outcome disparities for residents of long-term care, comparing minoritised populations to the context-specific dominant population. DESIGN: Systematic review. SUBJECTS: Residents of 24-hour long-term care homes. METHODS: The protocol was registered a priori with PROSPERO (CRD42021269489). Literature published between 1 January 2000 and 26 September 2021, was searched, including studies comparing baseline characteristics and outcomes in minoritised versus dominant populations. Dual screening, two-reviewer verification for extraction, and risk of bias assessments were conducted to ensure rigour. Studies were synthesized using a conceptual framework to contextualise evidence according to multi-level factors contributing to the development of care disparities. RESULTS: Twenty-one of 34 included studies demonstrated disparities in care outcomes for minoritised groups compared to majority groups. Thirty-one studies observed differences in individual-level characteristics (e.g. age, education, underlying conditions) upon entry to homes, with several outcome disparities (e.g. restraint use, number of medications) present at baseline and remaining or worsening over time. Significant gaps in evidence were identified, particularly an absence of literature on provider information and evidence on the experience of intersecting minority identities that contribute to care-related outcome disparities in long-term care. CONCLUSION: This review found differences in minoritised populations' care-related outcomes. The findings provide guidance for future health equity policy and research-supporting diverse and intersectional capacity building in long-term care.

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.

PROTOCOL: Effects of social prescribing for older adults: An evidence and gap map.

Objectives This is the protocol for an evidence and gap map. The objectives are as follows: The aim of this evidence and gap map is to map the available evidence on the effectiveness of social prescribing interventions addressing a non-medical, health-related social need for older adults in any setting. Specific objectives are as follows: 1.To identify existing evidence from primary studies and systematic reviews on the effects of community-based interventions that address non-medical, health-related social needs of older adults to improve their health and wellbeing.2.To identify research evidence gaps for new high-quality primary studies and systematic reviews.3.To highlight evidence of health equity considerations from included primary studies and systematic reviews.

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' 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' needs.

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.

Barriers and enablers to and strategies for promoting domestic plasma donation throughout the world: Overarching protocol for three systematic reviews.

INTRODUCTION: The growing demand for plasma protein products has caused concern in many countries who largely rely on importing plasma products produced from plasma collected in the United States and Europe. Optimizing recruitment and retention of a diversity of plasma donors is therefore important for supporting national donation systems that can reliably meet the most critical needs of health services. This series of three systematic reviews aims to synthesize the known barriers and enablers to source plasma donation from the qualitative and survey-based literature and identify which strategies that have shown to be effective in promoting increased intention to, and actual donation of, source plasma. METHODS AND ANALYSIS: Primary studies involving source or convalescent plasma donation via plasmapheresis will be included. The search strategy will capture all potentially relevant studies to each of the three reviews, creating a database of plasma donation literature. Study designs will be subsequently identified in the screening process to facilitate analysis according to the unique inclusion criteria of each review (i.e., qualitative, survey, and experimental designs). The search will be conducted in the electronic databases SCOPUS, MEDLINE, EMBASE, PsycINFO, and CINAHL without date or language restrictions. Studies will be screened, and data will be extracted, in duplicate by two independent reviewers with disagreements resolved through consensus. Reviews 1 and 2 will draw on the Theoretical Domains Framework and Intersectionality, while Review 3 will be informed by Behaviour Change Intervention Ontologies. Directed content analysis and framework analysis (Review 1), and descriptive and inferential syntheses (Reviews 2 and 3), will be used, including meta-analyses if appropriate. DISCUSSION: This series of related reviews will serve to provide a foundation of what is known from the published literature about barriers and enablers to, and strategies for promoting, plasma donation worldwide.

Digital interventions to reduce social isolation and loneliness in older adults: An evidence and gap map.

Background: Social isolation and loneliness are more common in older adults and are associated with a serious impact on their well-being, mental health, physical health, and longevity. They are a public health concern highlighted by the COVID-19 pandemic restrictions, hence the need for digital technology tools to enable remotely delivered interventions to alleviate the impact of social isolation and loneliness during the COVID-19 restrictions. Objectives: To map available evidence on the effects of digital interventions to mitigate social isolation and/or loneliness in older adults in all settings except hospital settings. Search Methods: We searched the following databases from inception to May 16, 2021, with no language restrictions. Ovid MEDLINE, Embase, APA PsycInfo via Ovid, CINAHL via EBSCO, Web of Science via Clarivate, ProQuest (all databases), International Bibliography of the Social Sciences (IBSS) via ProQuest, EBSCO (all databases except CINAHL), Global Index Medicus, and Epistemonikos. Selection Criteria: Titles and abstracts and full text of potentially eligible articles were independently screened in duplicate following the eligibility criteria. Data Collection and Analysis: We developed and pilot tested a data extraction code set in Eppi-Reviewer and data were individually extracted and coded based on an intervention-outcome framework which was also used to define the dimensions of the evidence and gap map. Main Results: We included 200 articles (103 primary studies and 97 systematic reviews) that assessed the effects of digital interventions to reduce social isolation and/or loneliness in older adults. Most of the systematic reviews (72%) were classified as critically low quality, only 2% as high quality and 25% were published since the COVID-19 pandemic. The evidence is unevenly distributed with clusters predominantly in high-income countries and none in low-income countries. The most common interventions identified are digital interventions to enhance social interactions with family and friends and the community via videoconferencing and telephone calls. Digital interventions to enhance social support, particularly socially assistive robots, and virtual pets were also common. Most interventions focused on reducing loneliness and depression and improving quality of life of older adults. Major gaps were identified in community level outcomes and process indicators. No included studies or reviews assessed affordability or digital divide although the value of accessibility and barriers caused by digital divide were discussed in three primary studies and three reviews. Adverse effects were reported in only two studies and six reviews. No study or review included participants from the LGBTQIA2S+ community and only one study restricted participants to 80 years and older. Very few described how at-risk populations were recruited or conducted any equity analysis to assess differences in effects for populations experiencing inequities across PROGRESS-Plus categories. Authors' Conclusions: The restrictions placed on people during the pandemic have shone a spotlight onto social isolation and loneliness, particularly for older adults. This evidence and gap map shows available evidence on the effectiveness of digital interventions for reducing social isolation or loneliness in older adults. Although the evidence is relatively large and recent, it is unevenly distributed and there is need for more high-quality research. This map can guide researchers and funders to consider areas of major gaps as priorities for further research.

Effectiveness of nutrition counseling for pregnant women in low- and middle-income countries to improve maternal and infant behavioral, nutritional, and health outcomes: A systematic review.

Background: Nutritional counseling, which includes two-way interactive education, has been hypothesized to improve the health and nutritional status of pregnant women, but little is known about the impact such practice of care might have on maternal and infant health and behavioral outcomes of pregnant women living in low income, low-middle income, and upper-middle-income countries (LMIC)s. Objectives: We conducted a systematic review to appraise the effectiveness and impact on health equity of two-way nutritional counseling practices in LMICs on maternal and infant behavioral, nutritional, and health outcomes. Search Methods: We conducted electronic searches for relevant studies on Medline, Embase, CINAHL, PsychInfo, and the Cochrane CENTRAL for randomized and non-randomized trials on the effectiveness of two-way interactive nutritional counseling among pregnant women from the date of database inception up to June 22, 2021. In addition, we searched references of included studies in systematic reviews, gray literature resources, and unpublished studies or reports that satisfied our eligibility criteria using a focused Google search. Selection Criteria: We included randomized and non-randomized controlled studies (NRS), controlled before and after, and interrupted time series that assessed the effectiveness of two-way interactive nutrition counseling targeting pregnant women in LMICs. Data Collection and Analysis: Data extraction and risk of bias were conducted in duplicate. The risk of bias (ROB) for randomized trials (RCT) was assessed according to the Cochrane Handbook of Systematic Reviews, and ROB for NRS was assessed using the Newcastle-Ottawa scale (NOS). RCT and NRS were meta-analyzed separately. Main Results: Our search identified 6418 records and 52 studies met our inclusion criteria, but only 28 were used in the quantitative analysis. Twenty-eight studies were conducted in Asia, the most in Iran. Eight studies were conducted in Africa. Two-way interactive nutritional counseling during pregnancy may improve dietary caloric intake (mean difference [MD]: 81.65 calories, 95% confidence interval [CI], 15.37-147.93, three RCTs; I 2 = 42%; moderate certainty of evidence using GRADE assessment), may reduce hemorrhage (relative risk [RR]: 0.63; 95% CI, 0.25-1.54, two RCTs; I 2 = 40%; very low certainty of evidence using GRADE assessment), may improve protein (MD: 10.44 g, 95% CI, 1.83-19.05, two RCTs; I 2 = 95%; high certainty of evidence using GRADE assessment), fat intake (MD: 3.42 g, 95% CI, -0.20 to 7.04, two RCTs; I 2 = 0%; high certainty of evidence using GRADE assessment), and may improve gestational weight gain within recommendations (RR: 1.84; 95% CI, 1.10-3.09, three RCTs; I 2 = 69%). Nutrition counseling probably leads to the initiation of breastfeeding immediately after birth (RR: 1.72; 95% CI, 1.42-2.09, one RCT). There was little to no effect on reducing anemia (RR: 0.77; 95% CI, 0.50-1.20, three RCTs; I 2 = 67%; very low certainty of evidence using GRADE assessment) risk of stillbirths (RR: 0.81; 95% CI, 0.52-1.27, three RCTs; I 2 = 0%; moderate certainty of evidence using GRADE assessment) and risk of cesarean section delivery (RR: 0.96; 95% CI, 0.76-1.20, four RCTs; I 2 = 36%; moderate certainty of evidence using GRADE assessment). Authors' Conclusions: Our review highlights improvements in maternal behavioral and health outcomes through interactive nutrition counseling during pregnancy. However, we are uncertain about the effects of nutrition counseling due to the low certainty of evidence and a low number of studies for some key outcomes. Moreover, the effects on health equity remain unknown. More methodologically rigorous trials that focus on a precise selection of outcomes driven by the theory of change of nutrition counseling to improve maternal and infant behavioral and health outcomes and consider equity are required.

Definitions, terminology, and related concepts of "racial health equity": a scoping review protocol.

BACKGROUND: In the USA, access to quality healthcare varies greatly across racial and ethnic groups, resulting in significant health disparities. A new term, "racial health equity" (RHE), is increasingly reported in the medical literature, but there is currently no consensus definition of the term. Additionally, related terms such as "health disparities," "health inequities," and "equality" have been inconsistently used when defining RHE. METHODS: The primary purpose of this scoping review is to investigate the current use and underlying concepts used to define racial health equity. The study will address two key questions: (1) "What terminology and definitions have been used to characterize RHE?" and (2) "What knowledge gaps and challenges are present in the current state of RHE research and theory?" The review will collect and analyze data from three sources: (1) websites from key national and international health organizations, (2) theoretical and narrative published articles, and (3) evidence synthesis studies addressing interventions targeting racial health equity and minority stakeholder engagement. DISCUSSION: Defining "racial health equity" and related terminology is the first step to advancing racial health equity within the USA. This review aims to offer an improved understanding of RHE constructs and definitions, bringing greater unity to national racial health equity research efforts across disciplines. SYSTEMATIC REVIEW REGISTRATION: This protocol is registered with the Open Science Framework at https://osf.io/7pvzq .

Protocol for a living evidence synthesis on variants of concern and COVID-19 vaccine effectiveness.

BACKGROUND: It is evident that COVID-19 will remain a public health concern in the coming years, largely driven by variants of concern (VOC). It is critical to continuously monitor vaccine effectiveness as new variants emerge and new vaccines and/or boosters are developed. Systematic surveillance of the scientific evidence base is necessary to inform public health action and identify key uncertainties. Evidence syntheses may also be used to populate models to fill in research gaps and help to prepare for future public health crises. This protocol outlines the rationale and methods for a living evidence synthesis of the effectiveness of COVID-19 vaccines in reducing the morbidity and mortality associated with, and transmission of, VOC of SARS-CoV-2. METHODS: Living evidence syntheses of vaccine effectiveness will be carried out over one year for (1) a range of potential outcomes in the index individual associated with VOC (pathogenesis); and (2) transmission of VOC. The literature search will be conducted up to May 2023. Observational and database-linkage primary studies will be included, as well as RCTs. Information sources include electronic databases (MEDLINE; Embase; Cochrane, L*OVE; the CNKI and Wangfang platforms), pre-print servers (medRxiv, BiorXiv), and online repositories of grey literature. Title and abstract and full-text screening will be performed by two reviewers using a liberal accelerated method. Data extraction and risk of bias assessment will be completed by one reviewer with verification of the assessment by a second reviewer. Results from included studies will be pooled via random effects meta-analysis when appropriate, or otherwise summarized narratively. DISCUSSION: Evidence generated from our living evidence synthesis will be used to inform policy making, modelling, and prioritization of future research on the effectiveness of COVID-19 vaccines against VOC.

The Commercial Determinants of Health and Evidence Synthesis (CODES): methodological guidance for systematic reviews and other evidence syntheses.

BACKGROUND: The field of the commercial determinants of health (CDOH) refers to the commercial products, pathways and practices that may affect health. The field is growing rapidly, as evidenced by the WHO programme on the economic and commercial determinants of health and a rise in researcher and funder interest. Systematic reviews (SRs) and evidence synthesis more generally will be crucial tools in the evolution of CDOH as a field. Such reviews can draw on existing methodological guidance, though there are areas where existing methods are likely to differ, and there is no overarching guidance on the conduct of CDOH-focussed systematic reviews, or guidance on the specific methodological and conceptual challenges. METHODS/RESULTS: CODES provides guidance on the conduct of systematic reviews focussed on CDOH, from shaping the review question with input from stakeholders, to disseminating the review. Existing guidance was used to identify key stages and to provide a structure for the guidance. The writing group included experience in systematic reviews and other forms of evidence synthesis, and in equity and CDOH research (both primary research and systematic reviews). CONCLUSIONS: This guidance highlights the special methodological and other considerations for CDOH reviews, including equity considerations, and pointers to areas for future methodological and guideline development. It should contribute to the reliability and utility of CDOH reviews and help stimulate the production of reviews in this growing field.

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.

Exploring COVID-19 education to support vaccine confidence amongst the general adult population with special considerations for healthcare and long-term care staff: A scoping review.

Background: Despite the demonstrated efficacy of approved COVID-19 vaccines, high levels of hesitancy were observed in the first few months of the COVID-19 vaccines' rollout. Factors contributing to vaccine hesitancy are well-described in the literature. Among the various strategies for promoting vaccine confidence, educational interventions provide a foundationally and widely implemented set of approaches for supporting individuals in their vaccine decisions. However, the evidence around the measurable impact of various educational strategies to improve vaccine confidence is limited. We conducted a scoping review with the aim of exploring and characterizing educational interventions delivered during the pandemic to support COVID-19 vaccine confidence in adults. Methods: We developed a search strategy with a medical information scientist and searched five databases, including Ovid MEDLINE and Web of Science, as well as grey literature. We considered all study designs and reports. Interventions delivered to children or adolescents, interventions on non-COVID-19 vaccines, as well as national or mass vaccination campaigns without documented interaction(s) between facilitator(s) and a specific audience were excluded. Articles were independently screened by three reviewers. After screening 4602 titles and abstracts and 174 full-text articles across two rounds of searches, 22 articles met our inclusion criteria. Ten additional studies were identified through hand searching. Data from included studies were charted and results were described narratively. Results: We included 32 studies and synthesized their educational delivery structure, participants (i.e., facilitators and priority audience), and content. Formal, group-based presentations were the most common type of educational intervention in the included studies (75%). A third of studies (34%) used multiple strategies, with many formal group-based presentations being coupled with additional individual-based interventions (29%). Given the novelty of the COVID-19 vaccines and the unique current context, studies reported personalized conversations, question periods, and addressing misinformation as important components of the educational approaches reviewed. Conclusions: Various educational interventions were delivered during the COVID-19 pandemic, with many initiatives involving multifaceted interventions utilizing both formal and informal approaches that leveraged community (cultural, religious) partnerships when developing and facilitating COVID-19 vaccine education. Train-the-trainer approaches with recognized community members could be of value as trust and personal connections were identified as strong enablers throughout the review.