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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 We will use these findings to develop draft guidance checklists and will assess agreement with each item through an international survey. 3.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. [ABSTRACT FROM AUTHOR]

Background: Adverse social determinants of health give rise to individual-level social needs that have the potential to negatively impact health. Screening patients to identify unmet social needs is becoming more widespread. A review of the content of currently available screening tools is warranted. The aim of this scoping review was to determine what social needs categories are included in published Social Needs Screening Tools that have been developed for use in primary care settings, and how these social needs are screened. Methods: We pre-registered the study on the Open Science Framework (https://osf. io/dqan2/). We searched MEDLINE and Embase from 01/01/2010 to 3/05/2022 to identify eligible studies reporting tools designed for use in primary healthcare settings. Two reviewers independently screened studies, a single reviewer extracted data. We summarised the characteristics of included studies descriptively and calculated the number of studies that collected data relevant to specific social needs categories. We identified sub-categories to classify the types of questions relevant to each of the main categories. Results: We identified 420 unique citations, and 27 were included. Nine additional studies were retrieved by searching for tools that were used or referred to in excluded studies. Questions relating to food insecurity and the physical environment in which a person lives were the most frequently included items (92-94% of tools), followed by questions relating to economic stability and aspects of social and community context (81%). Seventy-five percent of the screening tools included items that evaluated five or more social needs categories (mean 6.5; standard deviation 1.75). One study reported that the tool had been 'validated'; 16 reported 'partial' validation; 12 reported that the tool was 'not validated' and seven studies did not report validation processes or outcomes. [ABSTRACT FROM AUTHOR]

Background: Foot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure). Methods: COMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake. Conclusions: This protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains. Trial registration: This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081 [ABSTRACT FROM AUTHOR]

Key Points: Question: What outcome-specific information should be included in a clinical trial protocol? Findings: Using an evidence-based and international consensus–based approach that applied methods from the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, 9 outcome-specific reporting items to be addressed in clinical trial protocols were identified. Meaning: Inclusion of these items in clinical trial protocols may enhance trial utility, replicability, and transparency and may help limit selective nonreporting of trial results. Importance: Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. Objective: To develop harmonized, evidence- and consensus-based standards for describing outcomes in clinical trial protocols through integration with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for outcome-specific reporting to be addressed in clinical trial protocols. Findings: The scoping review and consultation with experts identified 108 recommendations relevant to outcome-specific reporting to be addressed in trial protocols, the majority (72%) of which were not included in the SPIRIT 2013 statement. All recommendations were consolidated into 56 items for Delphi voting; after the Delphi survey process, 19 items met criteria for further evaluation at the consensus meeting and possible inclusion in the SPIRIT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 9 items that elaborate on the SPIRIT 2013 statement checklist items and are related to completely defining and justifying the choice of primary, secondary, and other outcomes (SPIRIT 2013 statement checklist item 12) prospectively in the trial protocol, defining and justifying the target difference between treatment groups for the primary outcome used in the sample size calculations (SPIRIT 2013 statement checklist item 14), describing the responsiveness of the study instruments used to assess the outcome and providing details on the outcome assessors (SPIRIT 2013 statement checklist item 18a), and describing any planned methods to account for multiplicity relating to the analyses or interpretation of the results (SPIRIT 2013 statement checklist item 20a). Conclusions and Relevance: This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results. This report, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)–Outcomes 2022 extension, is a consensus statement on the standards for describing outcome-specific information in clinical trial protocols and contains recommendations to be integrated with the SPIRIT 2013 statement. [ABSTRACT FROM AUTHOR]

Key Points: Question: What outcome-specific information should be included in a published clinical trial report? Findings: Using an evidence-based and international consensus–based approach that applied methods from the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, 17 outcome-specific reporting items were identified. Meaning: Inclusion of these items in clinical trial reports may enhance trial utility, replicability, and transparency and may help limit selective nonreporting of trial results. Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results. This report, the Consolidated Standards of Reporting Trials (CONSORT)–Outcomes 2022 extension, is a consensus statement on the standards for reporting outcomes in clinical trial reports and contains recommendations to be integrated with the CONSORT 2010 statement. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the extent to which Cochrane Musculoskeletal systematic reviews assess and analyze health equity considerations.Methods: We included Cochrane Musculoskeletal systematic reviews that included trials with participants aged ≥ 50 years and that were published from 2015 to 2020. We assessed the extent to which reviews considered health equity in the description of the population in the PICO (Patient/Population - Intervention - Comparison/Comparator - Outcome) framework, data analysis (planned and conducted), description of participant characteristics, summary of findings, and applicability of results using the PROGRESS-Plus framework. The PROGRESS acronym stands for place of residence (rural or urban), race/ethnicity/culture/language, occupation, gender/sex, religion, education, socioeconomic status, and social capital, and Plus represents age, disability, relationship features, time-dependent relationships, comorbidities, and health literacy.Results: In total, 52 systematic reviews met our inclusion criteria. At least 1 element of PROGRESS-Plus was considered in 90% (47/52) of the reviews regarding the description of participants and in 85% (44/52) of reviews regarding question formulation. For participant description, the most reported factors were age (47/52, 90%) and sex (45/52, 87%). In total, 8 (15%) reviews planned to analyze outcomes by sex, age, and comorbidities. Only 1 had sufficient data to carry this out. In total, 19 (37%) reviews discussed the applicability of the results to 1 or more PROGRESS-Plus factor, most frequently across sex (12/52, 23%) and age (9/52, 17%).Conclusion: Sex and age were the most reported PROGRESS-Plus factors in any sections of the Cochrane Musculoskeletal reviews. We suggest a template for reporting participant characteristics that authors of reviews believe may influence outcomes. This could help patients and practitioners make judgments about applicability. [ABSTRACT FROM AUTHOR]

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Objective: To provide the initial installment of a living guideline that will provide up-to-date guidance on the pharmacological management of patients with rheumatoid arthritis (RA) in Canada.Methods: The Canadian Rheumatology Association (CRA) formed a multidisciplinary panel composed of rheumatologists, researchers, methodologists, and patients. In this first installment of our living guideline, the panel developed a recommendation for the tapering of biologic and targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) therapy in patients in sustained remission using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach, including a health equity framework developed for the Canadian RA population. The recommendation was adapted from a living guideline of the Australia & New Zealand Musculoskeletal Clinical Trials Network.Results: In people with RA who are in sustained low disease activity or remission for at least 6 months, we suggest offering stepwise reduction in the dose of b/tsDMARD without discontinuation, in the context of a shared decision, provided patients are able to rapidly access rheumatology care and reestablish their medications if needed. In patients where rapid access to care or reestablishing access to medications is challenging, we conditionally recommend against tapering. A patient decision aid was developed to complement the recommendation.Conclusion: This living guideline will provide contemporary RA management recommendations for Canadian practice. New recommendations will be added over time and updated, with the latest recommendation, evidence summaries, and Evidence to Decision summaries available through the CRA website (www.rheum.ca). [ABSTRACT FROM AUTHOR]

Objective: To generate initial data on the frequency and effect of symptomatic adverse events (AEs) associated with rheumatoid arthritis (RA) drug therapy from the patient perspective.Methods: We conducted an exploratory online survey asking patients with RA to indicate whether they currently or had ever experienced the 80 different symptomatic AEs included in the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Results were summarized to report their frequency, and regression models were used to estimate their associations with RA medication use and overall bother.Results: The 560 patients who completed the survey and reported taking ≥ 1 RA medication (disease-modifying antirheumatic drugs [DMARDs], steroids, nonsteroidal antiinflammatory drugs [NSAIDs]), had a mean disease duration of 8 years, and were on a wide range of DMARDs. The number of symptomatic AEs experienced in the past 7 days was none (6%), 1-10 (28%), 11-20 (28%), and > 20 (38%). Overall, most participants reported that side effects bothered them somewhat (28%), quite a bit (24%), or very much (15%). In multivariable regression analyses, current prednisone and NSAID use were associated with the greatest number of current side effects (26 and 22, respectively). Many of the strongest associations between current symptomatic AEs and medication use aligned with known side effect profiles.Conclusion: In this exploratory online survey, patients with RA reported frequent symptomatic AEs with their medications that are bothersome. Further work is needed to develop and validate a measure for use in patients with rheumatic disease. [ABSTRACT FROM AUTHOR]

This is the protocol for a Campbell systematic review. The objectives are as follows: to identify, describe, and summarize existing guidance and methods for multistakeholder engagement throughout the health guideline development process. [ABSTRACT FROM AUTHOR]

Background: There is a need for the development of comprehensive, global, evidence‐based guidance for stakeholder engagement in guideline development. Stakeholders are any individual or group who is responsible for or affected by health‐ and healthcare‐related decisions. This includes patients, the public, providers of health care and policymakers for example. As part of the guidance development process, Multi‐Stakeholder Engagement (MuSE) Consortium set out to conduct four concurrent systematic reviews to summarise the evidence on: (1) existing guidance for stakeholder engagement in guideline development, (2) barriers and facilitators to stakeholder engagement in guideline development, (3) managing conflicts of interest in stakeholder engagement in guideline development and (4) measuring the impact of stakeholder engagement in guideline development. This protocol addresses the second systematic review in the series. Objectives: The objective of this review is to identify and synthesise the existing evidence on barriers and facilitators to stakeholder engagement in health guideline development. We will address this objective through two research questions: (1) What are the barriers to multi‐stakeholder engagement in health guideline development across any of the 18 steps of the GIN‐McMaster checklist? (2) What are the facilitators to multi‐stakeholder engagement in health guideline development across any of the 18 steps of the GIN‐McMaster checklist? Search Methods: A comprehensive search strategy will be developed and peer‐reviewed in consultation with a medical librarian. We will search the following databases: MEDLINE, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE, PsycInfo, Scopus, and Sociological Abstracts. To identify grey literature, we will search the websites of agencies who actively engage stakeholder groups such as the AHRQ, Canadian Institutes of Health Research (CIHR) Strategy for Patient‐Oriented Research (SPOR), INVOLVE, the National Institute for Health and Care Excellence (NICE) and the PCORI. We will also search the websites of guideline‐producing agencies, such as the American Academy of Pediatrics, Australia's National Health Medical Research Council (NHMRC) and the WHO. We will invite members of the team to suggest grey literature sources and we plan to broaden the search by soliciting suggestions via social media, such as Twitter. Selection Criteria: We will include empirical qualitative and mixed‐method primary research studies which qualitatively report on the barriers or facilitators to stakeholder engagement in health guideline development. The population of interest is stakeholders in health guideline development. Building on previous work, we have identified 13 types of stakeholders whose input can enhance the relevance and uptake of guidelines: Patients, caregivers and patient advocates; Public; Providers of health care; Payers of health services; Payers of research; Policy makers; Program managers; Product makers; Purchasers; Principal investigators and their research teams; and Peer‐review editors/publishers. Eligible studies must describe stakeholder engagement at any of the following steps of the GIN‐McMaster Checklist for Guideline Development. Data Collection and Analysis: All identified citations from electronic databases will be imported into Covidence software for screening and selection. Documents identified through our grey literature search will be managed and screened using an Excel spreadsheet. A two‐part study selection process will be used for all identified citations: (1) a title and abstract review and (2) full‐text review. At each stage, teams of two review authors will independently assess all potential studies in duplicate using a priori inclusion and exclusion criteria. Data will be extracted by two review authors independently and in duplicate according to a standardised data extraction form. Main Results: The results of this review will be used to inform the development of guidance for multi‐stakeholder engagement in guideline development and implementation. This guidance will be official GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group guidance. The GRADE system is internationally recognised as a standard for guideline development. The findings of this review will assist organisations who develop healthcare, public health and health policy guidelines, such as the World Health Organization, to involve multiple stakeholders in the guideline development process to ensure the development of relevant, high quality and transparent guidelines. [ABSTRACT FROM AUTHOR]

This is the protocol for a Campbell systematic review. The overall objective of this study is to gather and summarize the existing literature on conflict of interest issues when engaging stakeholders in guideline development. [ABSTRACT FROM AUTHOR]

Objective: An unmet need exists for reliable, validated, and widely‐accepted outcome measures for randomized clinical trials in Behçet's syndrome. The Outcome Measures in Rheumatology (OMERACT) Behçet's Syndrome Working Group, a large, multidisciplinary group of experts in Behçet's syndrome and patients with Behçet's syndrome, had an objective of developing a core set of data‐driven outcome measures for use in all clinical trials of Behçet's syndrome. Methods: The core domain set was developed through a comprehensive, iterative, multistage project that included a systematic review, a focus group meeting and qualitative patient interviews, a survey among experts in Behçet's syndrome, a Delphi exercise involving both patients and physician experts in Behçet's syndrome, and use of the data, insight, and feedback generated by these processes to develop a final core domain set. Results: All steps were completed and domains were delineated across the organ systems involved in this disease. Since trials in Behçet's syndrome often focus on specific manifestations and not on the disease in its entirety, the final proposed core set includes 5 domains mandatory for study in all trials in Behçet's syndrome (disease activity, new organ involvement, quality of life, adverse events, and death) with additional subdomains mandatory for study of specific organ–systems. The final core set was endorsed at the 2018 OMERACT meeting. Conclusion: The core set of domains in Behçet's syndrome provides the foundation through which the international research community, including clinical investigators, patients, the biopharmaceutical industry, and government regulatory bodies can harmonize the study of this complex disease, compare findings across studies, and advance development of effective therapies. [ABSTRACT FROM AUTHOR]

Introduction: Pregnant and postpartum women face major psychological stressors that put them at higher risk of developing common mental disorders, such as depression and anxiety. Yet, their limited access to and uptake of traditional mental health care is inequitable, especially during the COVID-19 pandemic. Mobile interventions emerged as a potential solution to this discontinued healthcare access, but more knowledge is needed about their effectiveness and impact on health equity. This equity-focused systematic review examined the effectiveness and equity impact of mobile interventions targeting common mental disorders among pregnant and postpartum women. Methods and results: We systematically searched MEDLINE, EMBASE, PsychINFO and 3 other databases, from date of database inception and until January 2021, for experimental studies on mobile interventions targeting pregnant and postpartum women. We used pooled and narrative synthesis methods to analyze effectiveness and equity data, critically appraised the methodological rigour of included studies using Cochrane tools, and assessed the certainty of evidence using the GRADE approach. Our search identified 6148 records, of which 18 randomized and non-randomized controlled trials were included. Mobile interventions had a clinically important impact on reducing the occurrence of depression (OR = 0.51 [95% CI 0.41 to 0.64]; absolute risk reduction RD: 7.14% [95% CI 4.92 to 9.36]; p<0.001) and preventing its severity perinatally (MD = -3.07; 95% CI -4.68 to -1.46; p<0.001). Mobile cognitive behavioural therapy (CBT) was effective in managing postpartum depression (MD = -6.87; 95% CI -7.92 to -5.82; p<0.001), whereas other support-based interventions had no added benefit. Results on anxiety outcomes and utilization of care were limited. Our equity-focused analyses showed that ethnicity, age, education, and being primiparous were characteristics of influence to the effectiveness of mobile interventions. Conclusion: As the COVID-19 pandemic has increased the need for virtual mental health care, mobile interventions show promise in preventing and managing common mental disorders among pregnant and postpartum women. Such interventions carry the potential to address health inequity but more rigorous research that examines patients' intersecting social identities is needed. [ABSTRACT FROM AUTHOR]

Objective: When appraising the quality of randomised clinical trial (RCTs) on the merits of exercise therapy, we typically limit our assessment to the quality of the methods. However, heterogeneity across studies can also be caused by differences in the quality of the exercise interventions (ie, 'the potential effectiveness of a specific intervention given the potential target group of patients')-a challenging concept to assess. We propose an internationally developed, consensus-based tool that aims to assess the quality of exercise therapy programmes studied in RCTs: the international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) tool.Methods: Forty-nine experts (from 12 different countries) in the field of physical and exercise therapy participated in a four-stage Delphi approach to develop the i-CONTENT tool: (1) item generation (Delphi round 1), (2) item selection (Delphi rounds 2 and 3), (3) item specification (focus group discussion) and (4) tool development and refinement (working group discussion and piloting).Results: Out of the 61 items generated in the first Delphi round, consensus was reached on 17 items, resulting in seven final items that form the i-CONTENT tool: (1) patient selection; (2) qualified supervisor; (3) type and timing of outcome assessment; (4) dosage parameters (frequency, intensity, time); (5) type of exercise; (6) safety of the exercise programme and (7) adherence to the exercise programme.Conclusion: The i-CONTENT-tool is a step towards transparent assessment of the quality of exercise therapy programmes studied in RCTs, and ultimately, towards the development of future, higher quality, exercise interventions. [ABSTRACT FROM AUTHOR]

Objective: To describe the perspectives of patients with inflammatory arthritis (IA) on outcome domains of trials evaluating medication adherence interventions.Methods: Adult patients (≥ 18 yrs) with IA taking disease-modifying antirheumatic drugs from centers across Australia, Canada, and the Netherlands participated in 6 focus groups to discuss outcome domains that they consider important when participating in medication adherence trials. We analyzed the transcripts using inductive thematic analysis.Results: Of the 38 participants, 23 (61%) had rheumatoid arthritis and 21 (55%) were female. The mean age was 57.3 ± (SD 15.0) years. Improved outcome domains that patients wanted from participating in an adherence trial were categorized into 5 types: medication adherence, adherence-related factors (supporting adherence; e.g., medication knowledge), pathophysiology (e.g., physical functioning), life impact (e.g., ability to work), and economic impact (e.g., productivity loss). Three overarching themes reflecting why these outcome domains matter to patients were identified: how taking medications could improve patients' emotional and physical fitness to maintain their social function; how improving knowledge and confidence in self-management increases patients' trust and motivation to take medications as agreed with minimal risk of harms; and how respect and reassurance, reflecting health care that values patients' opinions and is sensitive to patients' individual goals, could improve medication-taking behavior.Conclusion: Patients value various outcome domains related to their overall well-being, confidence in medication use, and patient-healthcare provider relationships to be evaluated in future adherence trials. [ABSTRACT FROM AUTHOR]

Objective: To develop guidance on the use of coronavirus disease 2019 (COVID-19) vaccines in patients with autoimmune rheumatic diseases (ARD).Methods: The Canadian Rheumatology Association (CRA) formed a multidisciplinary panel including rheumatologists, researchers, methodologists, vaccine experts, and patients. The panel used the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Outcomes were prioritized according to their importance for patients and clinicians. Evidence from the COVID-19 clinical trials was summarized. Indirect evidence for non-COVID-19 vaccines in ARD was also considered. The GRADE evidence-to-decision (EtD) framework was used to develop a recommendation for the use of the 4 COVID-19 vaccines approved in Canada as of March 25, 2021 (BNT162b2, mRNA-1273, ChAdOx1, and Ad26.COV2.S), over 4 virtual panel meetings.Results: The CRA guideline panel suggests using COVID-19 vaccination in persons with ARD. The panel unanimously agreed that for the majority of patients, the potential health benefits of vaccination outweigh the potential harms in people with ARDs. The recommendation was graded as conditional because of low or very low certainty of the evidence on the effects in the population of interest, primarily due to indirectness and imprecise effect estimates. The panel felt strongly that persons with autoimmune rheumatic diseases who meet local eligibility should not be required to take additional steps compared to people without ARDs to obtain their vaccination. Guidance on medications, implementation, monitoring of vaccine uptake, and research priorities are also provided.Conclusion: This recommendation will be updated over time as new evidence emerges, with the latest recommendation, evidence summaries, and EtD available on the CRA website. [ABSTRACT FROM AUTHOR]

Objective: Osteoarthritis generates substantial health and socioeconomic burden, which is particularly marked in marginalized groups. It is imperative that practitioners have ready access to summaries of evidence-based interventions for osteoarthritis that incorporate equity considerations. Summaries of systematic reviews can provide this. The present study surveyed experts to prioritize a selection ofinterventions, from which equity focused summaries will be generated. Specifically, the prioritized interventions will be developed into Cochrane Evidence4Equity (E4E) summaries. Methods: Twenty-seven systematic reviews of OA interventions were found. From these, twenty-nine non-surgical treatments for osteoarthritis were identified, based on statistically significant findings for desired outcome variables or adverse events. Key findings from these studies were summarised and provided to 9 experts in the field of osteoarthritis.. Expert participants were asked to rate interventions based on feasibility, health system effects, universality, impact on inequities, and priority for translation into equity based E4E summaries. Expert participants were also encouraged to make comments to provide context for each rating. Free text responses were coded inductively and grouped into subthemes and themes. Results: Expert participants rated the intervention home land-based exercise for knee OA highest for priority for translation into an E4E summaries, followed by the interventions individual land-based exercise for knee OA, class land-based exercise for knee OA, exercise for hand OA and land-based exercise for hip OA. Upon qualitative analysis of the expert participants' comments, fifteen subthemes were identified and grouped into three overall themes: (1) this intervention or an aspect of this intervention is unnecessary or unsafe; (2) this intervention or an aspect of this intervention may increase health inequities; and (3) experts noted difficulties completing rating exercise. Conclusion: The list of priority interventions and corresponding expert commentary generated information that will be used to direct and support knowledge translation efforts. [ABSTRACT FROM AUTHOR]

Background: Investigations of transparency, reproducibility and replicability in science have been directed largely at individual studies. It is just as critical to explore these issues in syntheses of studies, such as systematic reviews, given their influence on decision-making and future research. We aim to explore various aspects relating to the transparency, reproducibility and replicability of several components of systematic reviews with meta-analysis of the effects of health, social, behavioural and educational interventions. Methods: The REPRISE (REProducibility and Replicability In Syntheses of Evidence) project consists of four studies. We will evaluate the completeness of reporting and sharing of review data, analytic code and other materials in a random sample of 300 systematic reviews of interventions published in 2020 (Study 1). We will survey authors of systematic reviews to explore their views on sharing review data, analytic code and other materials and their understanding of and opinions about replication of systematic reviews (Study 2). We will then evaluate the extent of variation in results when we (a) independently reproduce meta-analyses using the same computational steps and analytic code (if available) as used in the original review (Study 3), and (b) crowdsource teams of systematic reviewers to independently replicate a subset of methods (searches for studies, selection of studies for inclusion, collection of outcome data, and synthesis of results) in a sample of the original reviews; 30 reviews will be replicated by 1 team each and 2 reviews will be replicated by 15 teams (Study 4). Discussion: The REPRISE project takes a systematic approach to determine how reliable systematic reviews of interventions are. We anticipate that results of the REPRISE project will inform strategies to improve the conduct and reporting of future systematic reviews. [ABSTRACT FROM AUTHOR]

Objectives: The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term 'contextual factors' exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor' and its related terminology, identifying such factors and accounting for them in trials across rheumatology.Methods: We conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis.Results: We interviewed 12 researchers and 7 patients. Researcher's and patient's descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The 'treatment effect' theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The 'outcome measurement' theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types.Conclusions: Two main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders. [ABSTRACT FROM AUTHOR]

Patient-centered care is widely advocated in rheumatology. This involves collaboration among patients, caregivers, and health professionals and is particularly important in chronic rheumatic conditions because the disease and treatment can impair patients' health and well-being. Qualitative research can systematically generate insights about people's experiences, beliefs, and attitudes, which patients may not always express in clinical settings. These insights can address complex and challenging areas in rheumatology, such as treatment adherence and transition to adult healthcare services. Despite this, qualitative research comprises 1% of studies published in top-tier rheumatology journals. A better understanding about the effect and role, methods, and rigor of qualitative research is needed. This overview highlights the recent contributions of qualitative research in rheumatology, summarizes the common approaches and methods used, and outlines the key principles to guide appraisal of qualitative studies. [ABSTRACT FROM AUTHOR]

Objectives: Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. Methods: A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. Results: ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. Conclusions: ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool. [ABSTRACT FROM AUTHOR]

The article focuses on the update of the Canadian Rheumatology Association (CRA) guidelines for rheumatoid arthritis, introducing best practice statements and recommendations for disease-modifying antirheumatic drug therapy after an inadequate response to tumor necrosis factor inhibitors (TNFi). It mentions thease guidelines were developed using the GRADE approach and are accessible online, providing detailed evidence and rationale for each recommendation.

Objective: The core outcome set for trials in systemic sclerosis (SSc) was developed in 2008 and comprises 11 domains and 31 measures, leading to the development of the Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS). We aimed to assess the scope and consistency of outcomes reported in trials of SSc and the uptake of this core set and the CRISS.Methods: Medline, the Cochrane Central Register of Controlled Trials, Embase, and ClinicalTrials.gov were searched to identify randomized trials published from January 1, 2000 to April 29, 2018 in adults with limited or diffuse SSc. Outcomes and measures were recorded for each trial, classified into domains and the frequency of outcomes before after publication of the publication of the core set calculated.Results: From 152 trials, 4,193 outcomes were classified into 84 domains. The 3 most common domains were health-related quality of life (HRQoL) and function (59%, 130 measures), skin (47%, 59 measures), and pulmonary (45%, 168 measures). After the publication of the core outcome set, no trial reported the complete core set with adherence to each of the 11 domains, ranging from 6.1% to 54.4% and adherence to each of the 31 measures ranging from 0% to 48.1%. The 5 measures required for the CRISS were reported completely in 11% of trials.Conclusion: Despite recognition that uniform acquisition and reporting of outcomes would enable a better evaluation of proposed SSc therapeutics, the outcome domains and measures reported in randomized trials in SSc remain very inconsistent, with little impact of the core outcome set. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to identify and prioritize factors important to patients and caregivers with regard to medication adherence in gout, osteoporosis (OP), and rheumatoid arthritis (RA) and to describe the reasons for their decisions.Methods: Patients with gout, OP, and RA and their caregivers, purposively sampled from 5 rheumatology clinics in Australia, identified and ranked factors that they considered important for medication adherence using nominal group technique and discussed their decisions. An importance score (IS; scale 0-1) was calculated, and qualitative data were analyzed thematically.Results: From 14 focus groups, 82 participants (67 patients and 15 caregivers) identified 49 factors. The top 5 factors based on the ranking of all participants were trust in doctor (IS 0.46), medication effectiveness (IS 0.31), doctor's knowledge (IS 0.25), side effects (IS 0.23), and medication-taking routine (IS 0.13). The order of the ranking varied by participant groupings, with patients ranking "trust in doctor" the highest, while caregivers ranked "side effects" the highest. The 5 themes reflecting the reasons for factors influencing adherence were as follows: motivation and certainty in supportive individualized care; living well and restoring function; fear of toxicity and cumulative harm; seeking control and involvement; and unnecessarily difficult and inaccessible.Conclusion: Factors related to the doctor, medication properties, and patients' medication knowledge and routine were important for adherence. Strengthening doctor-patient trust and partnership, managing side effects, and empowering patients with knowledge and skills for taking medication could enhance medication adherence in patients with rheumatic conditions. [ABSTRACT FROM AUTHOR]

Objectives: To explore whether trial population characteristics modify treatment responses across various interventions, comparators and rheumatic conditions.Methods: In this meta-epidemiological study, we included trials from systematic reviews available from the Cochrane Musculoskeletal Group published up to 23 April 2019 in Cochrane Library with meta-analyses of five or more randomised controlled trials (RCTs) published from year 2000. From trial reports, we extracted data on 20 population characteristics. For characteristics with sufficient data (ie, available for ≥2/3 of the trials), we performed multilevel meta-epidemiological analyses.Results: We identified 19 eligible systematic reviews contributing 187 RCTs (212 comparisons). Only age and sex were explicitly reported in ≥2/3 of the trials. Using information about the country of the trials led to sufficient data for five further characteristics, that is, 7 out of 20 (35%) protocolised characteristics were analysed. The meta-regressions showed effect modification by economic status, place of residence, and, nearly, from healthcare system (explaining 4.8%, 0.9% and 1.5% of the between-trial variation, respectively). No effect modification was demonstrated from age, sex, patient education/health literacy or predominant religion.Conclusions: This study demonstrates the scarce reporting of most population characteristics, hampering investigation of their impact with meta-research. Our sparse results suggest that place of residence (ie, continent of the trial), economic status (based on World Bank classifications) and healthcare system (based on WHO index for health system performance) may be important in explaining the variation in treatment response across trials. There is an urgent need for consistent reporting of important population characteristics in trials.Prospero Registration Number: CRD42019127642. [ABSTRACT FROM AUTHOR]

Objective: Nonadherence to medications is common in rheumatic conditions and associated with increased morbidity. Heterogeneous outcome reporting by researchers compromises the synthesis of evidence of interventions targeting adherence. We aimed to assess the scope of outcomes in interventional studies of medication adherence.Methods: We searched electronic databases to February 2019 for published randomized controlled trials and observational studies of interventions with the primary outcome of medication adherence including adults with any rheumatic condition, written in English. We extracted and analyzed all outcome domains and adherence measures with prespecified extraction and analysis protocols.Results: Overall, 53 studies reported 71 outcome domains classified into adherence (1 domain), health outcomes (38 domains), and adherence-related factors (e.g., medication knowledge; 32 domains). We subdivided adherence into 3 phases: initiation (n = 13 studies, 25%), implementation (n = 32, 60%), persistence (n = 27, 51%), and phase unclear (n = 20, 38%). Thirty-seven different instruments reported adherence in 115 unique ways (this includes different adherence definitions and calculations, metric, and method of aggregation). Forty-one studies (77%) reported health outcomes. The most frequently reported were medication adverse events (n = 24, 45%), disease activity (n = 11, 21%), bone turnover markers/physical function/quality of life (each n = 10, 19%). Thirty-three studies (62%) reported adherence-related factors. The most frequently reported were medication beliefs (n = 8, 15%), illness perception/medication satisfaction/satisfaction with medication information (each n = 5, 9%), condition knowledge/medication knowledge/trust in doctor (each n = 3, 6%).Conclusion: The outcome domains and adherence measures in interventional studies targeting adherence are heterogeneous. Consensus on relevant outcomes will improve the comparison of different strategies to support medication adherence in rheumatology. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate, in a proof-of-concept study, a decision aid that incorporates hypothetical choices in the form of a discrete-choice experiment (DCE), to help patients with early rheumatoid arthritis (RA) understand their values and nudge them towards a value-centric decision between methotrexate and triple therapy (a combination of methotrexate, sulphasalazine and hydroxychloroquine). Patients and Methods: In the decision aid, patients completed a series of 6 DCE choice tasks. Based on the patient's pattern of responses, we calculated his/her probability of choosing each treatment, using data from a prior DCE. Following pilot testing, we conducted a cross-sectional study to determine the agreement between the predicted and final stated preference, as a measure of value concordance. Secondary outcomes including time to completion and usability were also evaluated. Results: Pilot testing was completed with 10 patients and adjustments were made. We then recruited 29 patients to complete the survey: median age 57, 55% female. The patients were all taking treatment and had well-controlled disease. The predicted treatment agreed with the final treatment chosen by the patient 21/29 times (72%), similar to the expected agreement from the mean of the predicted probabilities (68%). Triple therapy was the predicted treatment 24/29 times (83%) and chosen 20/29 (69%) times. Half of the patients (51%) agreed that completing the choice questions helped them to understand their preferences (38% neutral, 10% disagreed). The tool took an average of 15 minutes to complete, and median usability scores were 55 (system usability scale) indicating "OK" usability. Conclusion: Using a DCE as a value-clarification task within a decision aid is feasible, with promising potential to help nudge patients towards a value-centric decision. Usability testing suggests further modifications are needed prior to implementation, perhaps by having the DCE exercises as an "add-on" to a simpler decision aid. [ABSTRACT FROM AUTHOR]

Background: Homelessness is one of the most disabling and precarious living conditions. The objective of this Delphi consensus study was to identify priority needs and at-risk population subgroups among homeless and vulnerably housed people to guide the development of a more responsive and person-centred clinical practice guideline. Methods: We used a literature review and expert working group to produce an initial list of needs and at-risk subgroups of homeless and vulnerably housed populations. We then followed a modified Delphi consensus method, asking expert health professionals, using electronic surveys, and persons with lived experience of homelessness, using oral surveys, to prioritize needs and at-risk sub-populations across Canada. Criteria for ranking included potential for impact, extent of inequities and burden of illness. We set ratings of ≥ 60% to determine consensus over three rounds of surveys. Findings: Eighty four health professionals and 76 persons with lived experience of homelessness participated from across Canada, achieving an overall 73% response rate. The participants identified priority needs including mental health and addiction care, facilitating access to permanent housing, facilitating access to income support and case management/care coordination. Participants also ranked specific homeless sub-populations in need of additional research including: Indigenous Peoples (First Nations, Métis, and Inuit); youth, women and families; people with acquired brain injury, intellectual or physical disabilities; and refugees and other migrants. Interpretation: The inclusion of the perspectives of both expert health professionals and people with lived experience of homelessness provided validity in identifying real-world needs to guide systematic reviews in four key areas according to priority needs, as well as launch a number of working groups to explore how to adapt interventions for specific at-risk populations, to create evidence-based guidelines. [ABSTRACT FROM AUTHOR]

Background: Individuals who are homeless or vulnerably housed are at an increased risk for mental illness, other morbidities and premature death. Standard case management interventions as well as more intensive models with practitioner support, such as assertive community treatment, critical time interventions, and intensive case management, may improve healthcare navigation and outcomes. However, the definitions of these models as well as the fidelity and adaptations in real world interventions are highly variable. We conducted a systematic review to examine the effectiveness and cost-effectiveness of case management interventions on health and social outcomes for homeless populations. Methods and findings: We searched Medline, Embase and 7 other electronic databases for trials on case management or care coordination, from the inception of these databases to July 2019. We sought outcomes on housing stability, mental health, quality of life, substance use, hospitalization, income and employment, and cost-effectiveness. We calculated pooled random effects estimates and assessed the certainty of the evidence using the GRADE approach. Our search identified 13,811 citations; and 56 primary studies met our full inclusion criteria. Standard case management had both limited and short-term effects on substance use and housing outcomes and showed potential to increase hostility and depression. Intensive case management substantially reduced the number of days spent homeless (SMD -0.22 95% CI -0.40 to -0.03), as well as substance and alcohol use. Critical time interventions and assertive community treatment were found to have a protective effect in terms of rehospitalizations and a promising effect on housing stability. Assertive community treatment was found to be cost-effective compared to standard case management. Conclusions: Case management approaches were found to improve some if not all of the health and social outcomes that were examined in this study. The important factors were likely delivery intensity, the number and type of caseloads, hospital versus community programs and varying levels of participant needs. More research is needed to fully understand how to continue to obtain the increased benefits inherent in intensive case management, even in community settings where feasibility considerations lead to larger caseloads and less-intensive follow-up. [ABSTRACT FROM AUTHOR]

Background: The randomized controlled trial (RCT) is considered the gold standard study design to inform decisions about the effectiveness of interventions. However, a common limitation is inadequate reporting of the applicability of the intervention and trial results for people who are "socially disadvantaged" and this can affect policy-makers' decisions. We previously developed a framework for identifying health-equity-relevant trials, along with a reporting guideline for transparent reporting. In this study, we provide a descriptive assessment of health-equity considerations in 200 randomly sampled equity-relevant trials.Methods: We developed a search strategy to identify health-equity-relevant trials published between 2013 and 2015. We randomly sorted the 4316 records identified by the search and screened studies until 100 individually randomized (RCTs) and 100 cluster randomized controlled trials (CRTs) were identified. We developed and pilot-tested a data extraction form based on our initial work, to inform the development of our reporting guideline for equity-relevant randomized trials.Results: In total, 39 trials (20%) were conducted in a low- and middle-income country and 157 trials (79%) in a high-income country focused on socially disadvantaged populations (78% CRTs, 79% RCTs). Seventy-four trials (37%) reported a subgroup analysis across a population characteristic associated with disadvantage (25% CRT, 49% RCTs), with 19% of included studies reporting subgroup analyses across sex, 9% across race/ethnicity/culture, and 4% across socioeconomic status. No subgroup analyses were reported for place of residence, occupation, religion, education, or social capital. One hundred and forty-one trials (71%) discussed the applicability of their results to one or more socially disadvantaged populations (68% of CRT, 73% of RCT).Discussion: In this set of trials, selected for their relevance to health equity, data that were disaggregated for socially disadvantaged populations were rarely reported. We found that even when the data are available, opportunities to analyze health-equity considerations are frequently missed. The recently published equity extension of the Consolidated Reporting Standards for Randomized Trials (CONSORT-Equity) may help improve delineation of hypotheses related to socially disadvantaged populations, and transparency and completeness of reporting of health-equity considerations in RCTs. This study can serve as a baseline assessment of the reporting of equity considerations. [ABSTRACT FROM AUTHOR]

Background: Substance use is disproportionately high among people who are homeless or vulnerably housed. We performed a systematic overview of reviews examining the effects of selected harm reduction and pharmacological interventions on the health and social well-being of people who use substances, with a focus on homeless populations. Methods and findings: We searched MEDLINE, EMBASE, PsycINFO, Joanna Briggs Institute EBP, Cochrane Database of Systematic Reviews and DARE for systematic reviews from inception to August 2019. We conducted a grey literature search and hand searched reference lists. We selected reviews that synthesized evidence on supervised consumption facilities, managed alcohol programs and pharmacological interventions for opioid use disorders. We abstracted data specific to homeless or vulnerably housed populations. We assessed certainty of the evidence using the GRADE approach. Our search identified 483 citations and 30 systematic reviews met all inclusion criteria, capturing the results from 442 primary studies. This included three reviews on supervised consumption facilities, 24 on pharmacological interventions, and three on managed alcohol programs. Supervised consumption facilities decreased lethal overdoses and other high risk behaviours without any significant harm, and improved access to care. Pharmaceutical interventions reduced mortality, morbidity, and substance use, but the impact on retention in treatment, mental illness and access to care was variable. Managed alcohol programs reduced or stabilized alcohol consumption. Few studies on managed alcohol programs reported deaths. Conclusions: Substance use is a common chronic condition impacting homeless populations. Supervised consumption facilities reduce overdose and improve access to care, while pharmacological interventions may play a role in reducing harms and addressing other morbidity. High quality evidence on managed alcohol programs is limited. [ABSTRACT FROM AUTHOR]

Background: Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no 'gold standard' measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms. We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature.Methods: We searched nine commonly used databases (e.g., EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient-reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment.Results: We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g., abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n = 28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, although they also stressed goals under-reported in clinical trials.Conclusions: There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important.Trial Registration: PROSPERO, CRD42013006507. [ABSTRACT FROM AUTHOR]

With the increase in patient and consumer activism through the late twentieth century and into this century, patient roles in research evolved into a new model of research engagement, with patients serving as active advisors and co-leading or leading clinical research. By requiring active engagement of patients and other stakeholders, several government research funders have advanced this model, particularly in Canada, the United States (US), United Kingdom (UK), and Australia. A consortium of individuals from these countries formed a Multi-Stakeholder Engagement (MuSE) consortium to examine critical issues in engaged research, establish consensus on definitions, and provide guidance for the field, beginning with an overview of how to involve stakeholders in health research (Concannon et al. J Gen Intern Med. 2019;34(3):458-463) and continuing here with an examination of definitions of research engagement. The political and advocacy roots of engaged research are reflected in definitions. Engagement is conceptualized with reference to research project goals, from informing specific clinical decisions to informing health-system level decisions. Political and cultural differences across countries are evident. Some of these government funders focus on empirical rather than ethical rationales. In countries with centralized health technology assessment, the link between societal values and engaged research is explicit. Ethical rationales for engagement are explicit in most of the published literature on research engagement. Harmonization of definitions is recommended so that research engagement elements, methods, and outcomes and impacts can be clearly examined and understood, and so that the field of research engagement can proceed from a clear conceptual foundation. Specific recommendations for terminology definitions are provided. Placing engaged research on a continuum from specific clinical decisions to more global public and social justice concerns clarifies the type of engaged research, supports appropriate comparisons, and improves the rigor of engaged research methods. The results help identify knowledge gaps in this growing field. [ABSTRACT FROM AUTHOR]

Introduction As vaccine-preventable disease outbreaks increase, there is growing international interest in monitoring public attitudes towards vaccination and implementing and evaluating vaccine promotion interventions. Outcome selection and measurement are central to intervention evaluation. Measuring uptake rates alone cannot determine which elements in a multicomponent vaccine-promotion intervention are most effective, why specific populations are undervaccinated or when confidence in vaccines is wavering. To develop targeted and cost-effective interventions and policies, it is necessary to measure vaccination-related psychosocial factors such as knowledge, attitudes and aspects of decision-making. This scoping review aims to identify, compare and summarise the properties and validation of instruments for measuring vaccination-related psychosocial factors and identify gaps where no instruments exist. Methods and analysis We will search Medline OVID, Embase OVID, CINAHL and PsycINFO with no date restriction, using a pilot-tested search strategy of terms related to vaccination: knowledge, attitudes, trust, acceptance and decision-making and measurement, psychometric testing or validation. This search will be supplemented with manual search and expert consultation. We will include studies that describe instrument development, adaptation or testing and include evaluation of at least two measurement properties (eg, content, criterion, or construct validity; test–retest reliability; internal consistency; sensitivity; responsiveness). Instruments measuring a vaccination-related psychosocial factor in any population will be included. All studies will be screened by one reviewer, with a sample double-screened to confirm accuracy. Disagreements will be resolved with a third reviewer. Data will be synthesised narratively and through summary tables to chart and compare instrument characteristics such as factors measured, date and/ or location of development or validation, measurement properties evaluated and population. Ethics and dissemination This scoping review aims to provide an overview of existing instruments and ascertain measurement gaps where no measurement instruments currently exist. The identified instruments will form the basis of an open-access online repository of instruments. [ABSTRACT FROM AUTHOR]

Objective: Aspects of antineutrophil cytoplasmic antibodies-associated vasculitis (AAV) prioritized by patients with AAV were described using the International Classification of Function, Disability, and Health (ICF).Methods: Items identified during 14 individual interviews were incorporated into an ICF-based questionnaire administered to participants of 2 vasculitis patient symposia: 36 in the United Kingdom and 63 in the United States.Results: Categories identified as at least "moderately relevant" by ≥ 5% of subjects included 44 body functions, 14 body structures, 35 activities and participation, 31 environmental factors, and 38 personal factors.Conclusion: Identified categories differ from those identified by the current Outcome Measures in Rheumatology (OMERACT) core set and those prioritized by vasculitis experts. [ABSTRACT FROM AUTHOR]

Objective: The Outcome Measures in Rheumatology (OMERACT) Worker Productivity Group continues efforts to assess psychometric properties of measures of presenteeism.Methods: Psychometric properties of single-item and dual answer multiitem scales were assessed, as well as methods to evaluate thresholds of meaning.Results: Test-retest reliability and construct validity of single item global measures was moderate to good. The value of measuring both degree of difficulty and amount of time with difficulty in multiitems questionnaires was confirmed. Thresholds of meaning vary depending on methods and external anchors applied.Conclusion: We have advanced our understanding of the performance of presenteeism measures and have developed approaches to describing thresholds of meaning. [ABSTRACT FROM AUTHOR]

Objective: Establishing a research agenda on standardizing pain measurement in clinical trials in rheumatic and musculoskeletal diseases (RMD).Methods: Discussion during a meeting at the Outcome Measures in Rheumatology (OMERACT) 2018, prepared by a systematic review of existing core outcome sets and a patient online survey.Results: Several key questions were debated: Is pain a symptom or a disease? Are pain core (sub)domains consistent across RMD? How to account for pain mechanistic descriptors (e.g., central sensitization) in pain measurement?Conclusion: Characterizing and assessing the spectrum of pain experience across RMD in a standardized fashion is the objective of the OMERACT Pain Working Group. [ABSTRACT FROM AUTHOR]

Objective: The OMERACT-Adherence meeting was convened to discuss the conceptual and methodological challenges in developing a core domain set (Adherence-CDS) for trials of interventions for medication adherence in rheumatology.Methods: Forty participants from nine countries participated.Results: Four ideas emerged: for adherence trials, the Adherence-CDS could include adherence and the condition-specific CDS; many factors affect adherence and are intervention targets, contextual factors, or outcome domains; adherence is a critical factor in drug trials; and standardized adherence measures are needed.Conclusion: Despite the challenges, the meeting clarified an approach to developing an Adherence-CDS that complements existing OMERACT work and methodology. [ABSTRACT FROM AUTHOR]

Objective: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group seeks to develop validated outcome measures for use in trials for large-vessel vasculitis (LVV).Methods: An international Delphi exercise conducted among investigators identified items considered important to measure active disease. In parallel, qualitative research with patients was conducted, including interviews and focus groups.Results: Next steps prioritized by the group for LVV include (1) defining disease states (remission, flare, and patient-acceptable symptom state) and (2) selection of patient-reported outcome tools.Conclusion: The ultimate goal is to develop an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV. [ABSTRACT FROM AUTHOR]