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.

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.

Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials.

OBJECTIVE: To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions. METHODS: Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains. RESULTS: WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains. CONCLUSION: Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set. CLINICAL SIGNIFICANCE: The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions.

OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments.

OBJECTIVES: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2. METHODS: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table. RESULTS: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table. CONCLUSION: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains.

Interventions for Indigenous Peoples making health decisions: a systematic review.

BACKGROUND: Shared decision-making facilitates collaboration between patients and health care providers for informed health decisions. Our review identified interventions to support Indigenous Peoples making health decisions. The objectives were to synthesize evidence and identify factors that impact the use of shared decision making interventions. METHODS: An Inuit and non-Inuit team of service providers and academic researchers used an integrated knowledge translation approach with framework synthesis to coproduce a systematic review. We developed a conceptual framework to organize and describe the shared decision making processes and guide identification of studies that describe interventions to support Indigenous Peoples making health decisions. We conducted a comprehensive search of electronic databases from September 2012 to March 2022, with a grey literature search. Two independent team members screened and quality appraised included studies for strengths and relevance of studies' contributions to shared decision making and Indigenous self-determination. Findings were analyzed descriptively in relation to the conceptual framework and reported using guidelines to ensure transparency and completeness in reporting and for equity-oriented systematic reviews. RESULTS: Of 5068 citations screened, nine studies reported in ten publications were eligible for inclusion. We categorized the studies into clusters identified as: those inclusive of Indigenous knowledges and governance ("Indigenous-oriented")(n = 6); and those based on Western academic knowledge and governance ("Western-oriented")(n = 3). The studies were found to be of variable quality for contributions to shared decision making and self-determination, with Indigenous-oriented studies of higher quality overall than Western-oriented studies. Four themes are reflected in an updated conceptual framework: 1) where shared decision making takes place impacts decision making opportunities, 2) little is known about the characteristics of health care providers who engage in shared decision making processes, 3) community is a partner in shared decision making, 4) the shared decision making process involves trust-building. CONCLUSIONS: There are few studies that report on and evaluate shared decision making interventions with Indigenous Peoples. Overall, Indigenous-oriented studies sought to make health care systems more amenable to shared decision making for Indigenous Peoples, while Western-oriented studies distanced shared decision making from the health care settings. Further studies that are solutions-focused and support Indigenous self-determination are needed.

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.

A scoping review establishes need for consensus guidance on reporting health equity in observational studies.

OBJECTIVES: To evaluate the support from the available guidance on reporting of health equity in research for our candidate items and to identify additional items for the Strengthening Reporting of Observational studies in Epidemiology-Equity extension. STUDY DESIGN AND SETTING: We conducted a scoping review by searching Embase, MEDLINE, CINAHL, Cochrane Methodology Register, LILACS, and Caribbean Center on Health Sciences Information up to January 2022. We also searched reference lists and gray literature for additional resources. We included guidance and assessments (hereafter termed "resources") related to conduct and/or reporting for any type of health research with or about people experiencing health inequity. RESULTS: We included 34 resources, which supported one or more candidate items or contributed to new items about health equity reporting in observational research. Each candidate item was supported by a median of six (range: 1-15) resources. In addition, 12 resources suggested 13 new items, such as "report the background of investigators". CONCLUSION: Existing resources for reporting health equity in observational studies aligned with our interim checklist of candidate items. We also identified additional items that will be considered in the development of a consensus-based and evidence-based guideline for reporting health equity in observational studies.

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.

Cohort Trajectories by Age and Gender for Informal Caregiving in Europe Adjusted for Sociodemographic Changes, 2004 and 2015.

OBJECTIVES: We present a dynamic view of gender patterns in informal caregiving across Europe in a context of sociodemographic transformations. We aim to answer the following research questions: (a) has the gender gap in informal caregiving changed; (b) if so, is this due to changes among women and/or men; and (c) has the gender care gap changed differently across care regimes? METHODS: Multilevel growth curve models are applied to gendered trajectories of informal caregiving of a panel sample of 50+ Europeans, grouped into 5-year cohorts and followed across 5 waves of the Survey of Health, Ageing and Retirement in Europe survey, stratified by sex and adjusted for several covariates. RESULTS: For men in cohorts born more recently, there is a decrease in the prevalence of informal care outside the household, whereas cohort trajectories for women are mostly stable. Prevalence of care inside the household has increased for later-born cohorts for all without discernible changes to the gender care gap. Gender care gaps overall widened among later-born cohorts in the Continental cluster, whereas they remained constant in Southern Europe, and narrowed in the Nordic cluster. DISCUSSION: We discuss the cohort effects found in the context of gender differences in employment and care around retirement age, as well as possible demographic explanations for these. The shift from care outside to inside the household, where it mostly consists of spousal care, may require different policies to support carers, whose age profile and possible care burden seem to be increasing.

Cohort-specific disability trajectories among older women and men in Europe 2004-2017.

As the population of Europe grows older, one crucial issue is how the incidence and prevalence of disabilities are developing over time in the older population. In this study, we compare cohort-specific disability trajectories in old age across subsequent birth cohorts in Europe, during the period 2004-2017.We used data from seven waves of data from the Survey of Health, Ageing and Retirement in Europe (SHARE). Mixed effects logistic regression models were used to model trajectories of accumulation of ADL limitations for subsequent birth cohorts of older women and men in different European regions. The results showed that there were sex differences in ADL and IADL limitations in all regions for most cohorts. Women reported more limitations than men, particularly in Eastern and Southern rather than Northern and Western Europe. Among men in Eastern, Northern and Western Europe, later born cohorts reported more disabilities than did earlier born birth cohorts at the same ages. Similar patterns were observed for women in Northern and Western Europe. In contrast, the risk of disabilities was lower in later born cohorts than in earlier born birth cohorts among women in Eastern Europe. Overall, results from this study suggest that disability trajectories in different cohorts of men and women were by and large similar across Europe. The trajectories varied more depending on sex, age and region than depending on cohort. Supplementary Information: The online version contains supplementary material available at 10.1007/s10433-022-00684-4.

Understanding how and under what circumstances decision coaching works for people making healthcare decisions: a realist review.

BACKGROUND: Decision coaching is non-directive support delivered by a trained healthcare provider to help people prepare to actively participate in making healthcare decisions. This study aimed to understand how and under what circumstances decision coaching works for people making healthcare decisions. METHODS: We followed the realist review methodology for this study. This study was built on a Cochrane systematic review of the effectiveness of decision coaching interventions for people facing healthcare decisions. It involved six iterative steps: (1) develop the initial program theory; (2) search for evidence; (3) select, appraise, and prioritize studies; (4) extract and organize data; (5) synthesize evidence; and (6) consult stakeholders and draw conclusions. RESULTS: We developed an initial program theory based on decision coaching theories and stakeholder feedback. Of the 2594 citations screened, we prioritized 27 papers for synthesis based on their relevance rating. To refine the program theory, we identified 12 context-mechanism-outcome (CMO) configurations. Essential mechanisms for decision coaching to be initiated include decision coaches', patients', and clinicians' commitments to patients' involvement in decision making and decision coaches' knowledge and skills (four CMOs). CMOs during decision coaching are related to the patient (i.e., willing to confide, perceiving their decisional needs are recognized, acquiring knowledge, feeling supported), and the patient-decision coach interaction (i.e., exchanging information, sharing a common understanding of patient's values) (five CMOs). After decision coaching, the patient's progress in making or implementing a values-based preferred decision can be facilitated by the decision coach's advocacy for the patient, and the patient's deliberation upon options (two CMOs). Leadership support enables decision coaches to have access to essential resources to fulfill their role (one CMOs). DISCUSSION: In the refined program theory, decision coaching works when there is strong leadership support and commitment from decision coaches, clinicians, and patients. Decision coaches need to be capable in coaching, encourage patients' participation, build a trusting relationship with patients, and act as a liaison between patients and clinicians to facilitate patients' progress in making or implementing an informed values-based preferred option. More empirical studies, especially qualitative and process evaluation studies, are needed to further refine the program theory.

Gender differences in access to community-based care: a longitudinal analysis of widowhood and living arrangements.

Persistent inequalities in access to community-based support limit opportunities for independent living for older people with care needs in Europe. Our study focuses on investigating how gender, widowhood and living arrangement associate with the probability of receiving home and community-based care, while accounting for the shorter-term associations of transitions into widowhood (bereavement) and living alone, as well as the longer-term associations of being widowed and living alone. We use comparative, longitudinal data from the Survey of Health, Ageing and Retirement in Europe (collected between 2004 and 2015 in 15 countries) specifying sex-disaggregated random-effects within-between models, which allow us to examine both cross-sectional and longitudinal associations among widowhood, living arrangements and community-based care use. We find widowhood and living alone are independently associated with care use for both older women and men, while bereavement is associated with higher probability of care use only for women. Socio-economic status was associated with care use for older women, but not for men in our sample. The gender-specific associations we identify have important implications for fairness in European long-term care systems. They can inform improved care targeting towards individuals with limited informal care resources (e.g. bereaved older men) and lower socio-economic status, who are particularly vulnerable to experiencing unmet care needs. Gender differences are attenuated in countries that support formal care provision, suggesting gender equity can be promoted by decoupling access to care from household and family circumstances. Supplementary Information: The online version contains supplementary material available at 10.1007/s10433-022-00717-y.

Guidance relevant to the reporting of health equity in observational research: a scoping review protocol.

INTRODUCTION: Health inequities are defined as unfair and avoidable differences in health between groups within a population. Most health research is conducted through observational studies, which are able to offer real-world insights about etiology, healthcare policy/programme effectiveness and the impacts of socioeconomic factors. However, most published reports of observational studies do not address how their findings relate to health equity. Our team seeks to develop equity-relevant reporting guidance as an extension of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. This scoping review will inform the development of candidate items for the STROBE-Equity extension. We will operationalise equity-seeking populations using the PROGRESS-Plus framework of sociodemographic factors. As part of a parallel stream of the STROBE-Equity project, the relevance of candidate guideline items to Indigenous research will be led by Indigenous coinvestigators on the team. METHODS AND ANALYSIS: We will follow the Joanna Briggs Institute method for conducting scoping reviews. We will evaluate the extent to which the identified guidance supports or refutes our preliminary candidate items for reporting equity in observational studies. These candidate items were developed based on items from equity-reporting guidelines for randomised trials and systematic reviews, developed by members of this team. We will consult with our knowledge users, patients/public partners and Indigenous research steering committee to invite suggestions for relevant guidance documents and interpretation of findings. If the identified guidance suggests the need for additional candidate items, they will be developed through inductive thematic analysis. ETHICS AND DISSEMINATION: We will follow a principled approach that promotes ethical codevelopment with our community partners, based on principles of cultural safety, authentic partnerships, addressing colonial structures in knowledge production and the shared ownership, interpretation, and dissemination of research. All products of this research will be published as open access.

The needs of gynecological cancer survivors at the end of primary treatment: A scoping review and proposed model to guide clinical discussions.

OBJECTIVE: Gynecological cancer (GC) survivors have unmet needs when they complete primary cancer treatment. Despite this, no known research has summarized these needs and survivors' suggestions to address them. We conducted a scoping review to fill these gaps and develop a model useful to guide clinical discussions and/or interventions. METHODS: English, full length, and accessible primary studies describing the needs of GC survivors were included. No restrictions on date nor country of publication were applied. Two reviewers screened and extracted data, which was verified by a third reviewer. RESULTS: Seventy-one studies met the inclusion criteria for data extraction. Results were thematically grouped into seven dimensions: physical needs, sexuality-related concerns, altered self-image, psychological wellbeing, social support needs, supporting the return to work, and healthcare challenges and preferences. After consulting with a stakeholder group (a GC survivor, clinicians, and researchers), the dimensions were summarized into a proposed model to guide clinical assessments and/or interventions. CONCLUSION: Results illuminate the diverse needs of GC survivors as they complete primary cancer treatment and their recommendations for care to meet these needs. PRACTICE IMPLICATIONS: The resulting model can be used to guide assessments, discussions and/or interventions to optimally prepare GC survivors for transition out of primary cancer treatment.

Decision coaching for people making healthcare decisions.

BACKGROUND: Decision coaching is non-directive support delivered by a healthcare provider to help patients prepare to actively participate in making a health decision. 'Healthcare providers' are considered to be all people who are engaged in actions whose primary intent is to protect and improve health (e.g. nurses, doctors, pharmacists, social workers, health support workers such as peer health workers). Little is known about the effectiveness of decision coaching. OBJECTIVES: To determine the effects of decision coaching (I) for people facing healthcare decisions for themselves or a family member (P) compared to (C) usual care or evidence-based intervention only, on outcomes (O) related to preparation for decision making, decisional needs and potential adverse effects. SEARCH METHODS: We searched the Cochrane Library (Wiley), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), CINAHL (Ebsco), Nursing and Allied Health Source (ProQuest), and Web of Science from database inception to June 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) where the intervention was provided to adults or children preparing to make a treatment or screening healthcare decision for themselves or a family member. Decision coaching was defined as: a) delivered individually by a healthcare provider who is trained or using a protocol; and b) providing non-directive support and preparing an adult or child to participate in a healthcare decision. Comparisons included usual care or an alternate intervention. There were no language restrictions. DATA COLLECTION AND ANALYSIS: Two authors independently screened citations, assessed risk of bias, and extracted data on characteristics of the intervention(s) and outcomes. Any disagreements were resolved by discussion to reach consensus. We used the standardised mean difference (SMD) with 95% confidence intervals (CI) as the measures of treatment effect and, where possible, synthesised results using a random-effects model. If more than one study measured the same outcome using different tools, we used a random-effects model to calculate the standardised mean difference (SMD) and 95% CI. We presented outcomes in summary of findings tables and applied GRADE methods to rate the certainty of the evidence. MAIN RESULTS: Out of 12,984 citations screened, we included 28 studies of decision coaching interventions alone or in combination with evidence-based information, involving 5509 adult participants (aged 18 to 85 years; 64% female, 52% white, 33% African-American/Black; 68% post-secondary education). The studies evaluated decision coaching used for a range of healthcare decisions (e.g. treatment decisions for cancer, menopause, mental illness, advancing kidney disease; screening decisions for cancer, genetic testing). Four of the 28 studies included three comparator arms.  For decision coaching compared with usual care (n = 4 studies), we are uncertain if decision coaching compared with usual care improves any outcomes (i.e. preparation for decision making, decision self-confidence, knowledge, decision regret, anxiety) as the certainty of the evidence was very low.  For decision coaching compared with evidence-based information only (n = 4 studies), there is low certainty-evidence that participants exposed to decision coaching may have little or no change in knowledge (SMD -0.23, 95% CI: -0.50 to 0.04; 3 studies, 406 participants). There is low certainty-evidence that participants exposed to decision coaching may have little or no change in anxiety, compared with evidence-based information. We are uncertain if decision coaching compared with evidence-based information improves other outcomes (i.e. decision self-confidence, feeling uninformed) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with usual care (n = 17 studies), there is low certainty-evidence that participants may have improved knowledge (SMD 9.3, 95% CI: 6.6 to 12.1; 5 studies, 1073 participants). We are uncertain if decision coaching plus evidence-based information compared with usual care improves other outcomes (i.e. preparation for decision making, decision self-confidence, feeling uninformed, unclear values, feeling unsupported, decision regret, anxiety) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with evidence-based information only (n = 7 studies), we are uncertain if decision coaching plus evidence-based information compared with evidence-based information only improves any outcomes (i.e. feeling uninformed, unclear values, feeling unsupported, knowledge, anxiety) as the certainty of the evidence was very low. AUTHORS' CONCLUSIONS: Decision coaching may improve participants' knowledge when used with evidence-based information. Our findings do not indicate any significant adverse effects (e.g. decision regret, anxiety) with the use of decision coaching. It is not possible to establish strong conclusions for other outcomes. It is unclear if decision coaching always needs to be paired with evidence-informed information. Further research is needed to establish the effectiveness of decision coaching for a broader range of outcomes.

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.

Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach.

OBJECTIVE: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions. METHODS: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set. RESULTS: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention. CONCLUSION: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set. CLINICAL SIGNIFICANCE: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.

Experiences of Inuit in Canada who travel from remote settings for cancer care and impacts on decision making.

BACKGROUND: Inuit experience the highest cancer mortality rates from lung cancer in the world with increasing rates of other cancers in addition to other significant health burdens. Inuit who live in remote areas must often travel thousands of kilometers to large urban centres in southern Canada and negotiate complex and sometimes unwelcoming health care systems. There is an urgent need to improve Inuit access to and use of health care. Our study objective was to understand the experiences of Inuit in Canada who travel from a remote to an urban setting for cancer care, and the impacts on their opportunities to participate in decisions during their journey to receive cancer care. METHODS: We are an interdisciplinary team of Steering Committee and researcher partners ("the team") from Inuit-led and/or -specific organizations that span Nunavut and the Ontario cancer health systems. Guided by Inuit societal values, we used an integrated knowledge translation (KT) approach with qualitative methods. We conducted semi-structured interviews with Inuit participants and used process mapping and thematic analysis. RESULTS: We mapped the journey to receive cancer care and related the findings of client (n = 8) and medical escort (n = 6) ("participant") interviews in four themes: 1) It is hard to take part in decisions about getting health care; 2) No one explains the decisions you will need to make; 3) There is a duty to make decisions that support family and community; 4) The lack of knowledge impacts opportunities to engage in decision making. Participants described themselves as directed, with little or no support, and seeking opportunities to collaborate with others on the journey to receive cancer care. CONCLUSIONS: We describe the journey to receive cancer care as a "decision chain" which can be described as a series of events that lead to receiving cancer care. We identify points in the decision chain that could better prepare Inuit to participate in decisions related to their cancer care. We propose that there are opportunities to build further health care system capacity to support Inuit and enable their participation in decisions related to their cancer care while upholding and incorporating Inuit knowledge.

Guidance and/or Decision Coaching with Patient Decision Aids: Scoping Reviews to Inform the International Patient Decision Aid Standards (IPDAS).

INTRODUCTION: In 2005, the International Patient Decision Aid Standards (IPDAS) collaboration identified guidance and decision coaching as important dimensions of patient decision aids (PtDAs) and developed a set of quality criteria. We sought to update definitions, theoretical rationale, and evidence for guidance and/or decision coaching used within or alongside PtDAs for the IPDAS update 2.0. METHODS: We conducted 2 scoping reviews on guidance and decision coaching, including systematic searches and a hand search of the Cochrane Review on PtDAs. Eligible studies were randomized controlled trials (RCTs) on guidance or decision coaching used with/alongside PtDAs. Data, including conceptual models, were summarized narratively and with meta-analyses when appropriate. RESULTS: Of 1022 citations, we found no RCTs that evaluated guidance in PtDAs. The 2013 definition for guidance was endorsed, and we made minimal changes to the description of guidance. Of 3039 citations, we identified 21 RCTs on decision coaching informed by 5 conceptual models stating that people exposed to decision coaching are more likely to progress in making informed decisions consistent with their values. Compared to usual care, decision coaching with PtDAs led to improved knowledge mean difference [MD], 19.5/100; 95% confidence interval [CI], 10.0-29.0; 5 RCTs). Compared to decision coaching alone, PtDAs led to a small improvement in knowledge (MD, 3.6/100; 95% CI, 1.0-6.3; 3 RCTs). There were variable effects on other outcomes. We simplified the decision coaching definition slightly and defined minimal decision coaching elements. CONCLUSION: We found no evidence on which to propose changes in guidance in IPDAS. Decision coaching is continuing to be used alongside PtDAs, but there is inadequate evidence on the added effectiveness compared to PtDAs alone. The decision coaching definition was updated with minimal elements.