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Background: The evidence for testing thiopurine S-methyltransferase (TPMT) enzymatic activity or genotype before starting therapy with thiopurine-based drugs is unclear. Purpose: To examine the sensitivity and specificity of TPMT genotyping for TPMT enzymatic activity, reducing harm from thiopurine by pretesting, and the association of thiopurine toxicity with TPMT status in adults and children with chronic inflammatory diseases. Data Sources: MEDLINE, EMBASE, the Cochrane Library, and Ovid HealthSTAR (from inception to December 2010) and BIOSIS and Genetics Abstracts (to May 2009). Study Selection: Two reviewers screened records and identified relevant studies in English. Data Extraction: Data on patient characteristics, outcomes, and risk for bias were extracted by one reviewer and independently identified by another. Data Synthesis: 54 observational studies and 1 randomized, controlled trial were included. Insufficient evidence addressed the effectiveness of pretesting. Genotyping sensitivity to identify patients with low and intermediate TPMT enzymatic activity ranged from 70.33% to 86.15% (lower-bound 95% CI, 54.52% to 70.88%; upper-bound CI, 78.50% to 96.33%). Sparse data precluded estimation of genotype sensitivity to identify patients with low to absent enzymatic activity. Genotyping specificity approached 100%. Compared with noncarriers, heterozygous and homozygous genotypes were both associated with leukopenia (odds ratios, 4.29 [CI, 2.67 to 6.89] and 20.84 [CI, 3.42 to 126.89], respectively). Compared with intermediate or normal activity, low TPMT enzymatic activity was significantly associated with myelotoxicity and leukopenia. Limitation: Available evidence was not rigorous and was underpowered to detect a difference in outcomes. Conclusion: Insufficient evidence addresses the effectiveness of TPMT pretesting in patients with chronic inflammatory diseases. Estimates of the sensitivity of genotyping are imprecise. Evidence confirms the known associations of leukopenia or myelotoxicity with reduced TPMT activity or variant genotype. Primary Funding Source: Agency for Healthcare Research and Quality. [ABSTRACT FROM AUTHOR]

Objective: The objectives of this review are to identify barriers/facilitators to designing, maintaining, and utilizing rare disease patient registries (RDPRs); determine whether and how these differ among patient partners, other knowledge users (KUs), and researchers; and chart definitions of rare diseases and RDPRs., Introduction: RDPRs are vital to improving the understanding of the natural histories and predictors of outcomes for rare diseases, assessing interventions, and identifying potential participants for clinical trials. Currently, however, the functionality of RDPRs is not fully optimized. To improve the quality and functionality of RDPRs, it is important to understand the barriers and/or facilitators involved in their design, maintenance, and utilization; how these might differ among patient partners, other KUs, and researchers; and to delineate the range of definitions for rare diseases and RDPRs., Inclusion Criteria: Evidence of any study design or format (including empirical studies, books, manuals, commentaries, editorials, guidance documents, conference abstracts, review documents, and gray literature) referencing barriers/facilitators for designing, maintaining, or utilizing RDPRs will be considered for inclusion., Methods: The review will follow the JBI methodology for scoping reviews. We will search health science databases, including the Cochrane Library, Embase, MEDLINE, the JBI EBP Database, and PsycINFO, from inception onwards, as well as gray literature using the Canadian Agency for Drugs and Technologies in Health (CADTH) Grey Matters guidance. Two independent reviewers will screen titles and abstracts and full-text documents, as well as abstract data. Disagreements will be resolved through discussion or with a third reviewer. Evidence will be synthesized descriptively and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRIMSA-ScR)., Review Registration: Open Science Framework https://osf.io/mvf9r., Competing Interests: ACT is a member of the JBI Evidence Synthesis editorial board but was not involved in the editorial decision-making for this paper. The other authors declare no conflict of interest., (Copyright © 2024 JBI.)

Scoping reviews are a type of evidence synthesis that aims to identify and map the breadth of evidence available on a particular topic, field, concept, or issue, within or across a defined context or contexts. Scoping reviews can contribute to clinical practice guideline development, policy making, reduce research waste by eliminating duplication of research effort, and be a precursor to a systematic review. This paper aims to provide a brief introduction of how to conduct and report scoping reviews, their role and value of within the evidence synthesis ecosystem, the differences and similarities between these reviews and other types of evidence syntheses such as systematic reviews, mapping reviews, evidence and gap maps and overviews and how to overcome common challenges often associated in the conduct, reporting and dissemination of scoping reviews., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To map whether and how systematic reviews (SRs) with network meta-analysis (NMA) use presentation formats to report (a) structured evidence summaries - here defined as reporting of effects estimates in absolute effects with certainty ratings and with a method to rate interventions across one or more outcome(s) - and (b) NMA results in general., Study Design and Setting: We conducted a systematic survey, searching MEDLINE (Ovid) for SRs with NMA published between January 1, 2020, and December 31, 2021. We planned to include a random sample of publications, with predefined mechanisms in place for saturation, and included SRs that met prespecified quality criteria and extracted data on presentation formats that reported: (a) estimates of effects, (b) certainty of the evidence, or (c) rating of interventions., Results: The 200 eligible SRs, from 158 unique Journals, utilized 1133 presentation formats. We found structured evidence summaries in 10 publications (5.0%), with 3 (1.5%) reporting structured evidence summaries across all outcomes, including benefits and harms. Sixteen of the 133 SRs (11.7%) reporting dichotomous outcomes included estimates of absolute effects. Seventy-six SRs (38.0%) reported both benefits and harms and 26 SRs (13.0%) reported certainty ratings in presentation formats, 20 (76.9%) used Grading of Recommendations Assessment, Development and Evaluation and 6 (23.1%) used Confidence In Network Meta-analysis. Surface Under the Cumulative Ranking Curve was the most common method to rate interventions (69 SRs, 34.5%). NMA results were most often reported using forest plots (108 SRs, 54.0%) and league tables (93 SRs, 46.5%)., Conclusion: Most SRs with NMA do not report structured evidence summaries and only rarely do such summaries include reporting of both benefits and harms; those that do offer effective user-friendly communication and provide models for optimal NMA presentation practice., Competing Interests: Declaration of competing interest T.A. reports a relationship with MAGIC Evidence Ecosystem Foundation that includes: board membership and employment. P.O.V. reports a relationship with MAGIC Evidence Ecosystem Foundation that includes: board membership and employment. P.O.V. and T.A. are CEO and deputy CEO of the nonprofit organization MAGIC Evidence Ecosystem Foundation (https://www.magicevidence.org). In collaboration with P.O.L. at Lovisenberg Diaconal Hospital, MAGIC is conducting the research project Making Alternative Treatment Choices Intuitive and Trustworthy (MATCH-IT). The overarching aim of MATCH-IT is to develop a new interactive SoF table and decision support tool, displaying multiple structured evidence summaries from NMAs. The tool may be integrated as part of MAGICapp (https://app.magicapp.org/#/guidelines), an online author and publication platform for guidelines, evidence summaries and decision aids. A.A.V. is Statistical Associate Editor for the Journal of Clinical Epidemiology, but had no involvement with the peer review process or decision for publication. A.C.T. is Coeditor-in-Chief for the Journal of Clinical Epidemiology, but had no involvement with the peer review process or decision for publication. X.W., T.P., M.Ø., and C.L. declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Abstract: Some patients with back pain contribute disproportionately to high healthcare costs; however, characteristics of high-cost users with back pain are not well defined. We described high-cost healthcare users based on total costs among a population-based cohort of adults with back pain within the Ontario government's single-payer health system across sociodemographic, health, and behavioural characteristics. We conducted a population-based cohort study of Ontario adult (aged 18 years or older) respondents of the Canadian Community Health Survey (CCHS) with back pain (2003-2012), linked to administrative data (n = 36,605; weighted n = 2,076,937, representative of Ontario). Respondents were ranked based on gradients of total healthcare costs (top 1%, top 2%-5%, top 6%-50%, and bottom 50%) for 1 year following the CCHS survey, with high-cost users as top 5%. We used multinomial logistic regression to investigate characteristics associated with the 4 cost groups. Top 5% of cost users accounted for 49% ($4 billion CAD) of total healthcare spending, with inpatient hospital care as the largest contributing service type (approximately 40% of costs). Top 5% high-cost users were more likely aged 65 years or older (OR top1% = 16.6; OR top2-5% = 44.2), with lower income (OR top1% = 3.6; OR top 2-5% = 1.8), chronic disease(s) (OR top1% = 3.8; OR top2-5% = 1.6), Aggregated Diagnosis Groups measuring comorbidities (OR top1% = 25.4; OR top2-5% = 13.9), and fair/poor self-rated general health (OR top1% = 6.7; OR top2-5% = 4.6) compared with bottom 50% users. High-cost users tended to be current/former smokers, obese, and report fair/poor mental health. High-cost users (based on total costs) among adults with back pain account for nearly half of all healthcare spending over a 1-year period and are associated with older age, lower income, comorbidities, and fair/poor general health. Findings identify characteristics associated with a high-risk group for back pain to inform healthcare and public health strategies that target upstream determinants., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Background and Objective: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024., Methods: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement., Results: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts., Conclusion: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: This paper was jointly developed by Journal of Clinical Epidemiology, Quality of Life Research, Journal of Patient Reported Outcomes, Health and Quality of Life Outcomes and jointly published by Elsevier Inc, Springer Nature Switzerland AG, and BioMed Central Ltd., part of Springer Nature. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article., Competing Interests: Declaration of competing interest Drs Terwee and Mokkink are the founders of COSMIN; Dr Moher is a member of the PRISMA executive; Dr Tricco is the co-editor in chief of the Journal of Clinical Epidemiology. The other authors have no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Recently, Ades and colleagues discussed the controversies and advancements in network meta-analysis (NMA) over the past two decades, discussing its reliability, assumptions, novel approaches, and provided some useful recommendations for the conduction of NMAs. The present discussion paper builds on the insights by Ades and colleagues, providing a roadmap for NMA applications, advancements in software and tools, and approaches designed to facilitate the assessment and interpretation of NMA findings. It also discusses the impact of NMA across disciplines, particularly for policymakers and guideline developers. Despite 20 years of NMA history, challenges remain in understanding and assessing assumptions, communicating and interpreting findings, and applying common approaches like network meta-regression and NMA involving non-randomized studies in readily available software. NMA has proven particularly valuable in clinical decision-making, which highlights the need for additional training and interdisciplinary collaboration of knowledge users, including patient engagement, to enhance its adoption and address real-world problems., (© 2024 The Author(s). Research Synthesis Methods published by John Wiley & Sons Ltd.)

Objectives: To compare the efficacy of influenza vaccines of any valency for adults 60 years and older., Design and Setting: Systematic review with network meta-analysis (NMA) of randomised controlled trials (RCTs). MEDLINE, EMBASE, JBI Evidence-Based Practice (EBP) Database, PsycINFO, and Cochrane Evidence -Based Medicine database were searched from inception to 20 June 20, 2022. Two reviewers screened, abstracted, and appraised articles (Cochrane Risk of Bias (ROB) 2.0 tool) independently. We assessed certainty of findings using Confidence in Network Meta-Analysis and Grading of Recommendations, Assessment, Development and Evaluations approaches. We performed random-effects meta-analysis and network meta-analysis (NMA), and estimated odds ratios (ORs) for dichotomous outcomes and incidence rate ratios (IRRs) for count outcomes along with their corresponding 95% confidence intervals (CIs) and prediction intervals., Participants: Older adults (≥60 years old) receiving an influenza vaccine licensed in Canada or the USA (vs placebo, no vaccine, or any other licensed vaccine), at any dose., Main Outcome Measures: Laboratory-confirmed influenza (LCI) and influenza-like illness (ILI). Secondary outcomes were the number of vascular adverse events, hospitalisation for acute respiratory infection (ARI) and ILI, inpatient hospitalisation, emergency room (ER) visit for ILI, outpatient visit, and mortality, among others., Results: We included 41 RCTs and 15 companion reports comprising 8 vaccine types and 206 032 participants. Vaccines may prevent LCI compared with placebo, with high-dose trivalent inactivated influenza vaccine (IIV3-HD) (NMA: 9 RCTs, 52 202 participants, OR 0.23, 95% confidence interval (CI) (0.11 to 0.51), low certainty of evidence) and recombinant influenza vaccine (RIV) (OR 0.25, 95%CI (0.08 to 0.73), low certainty of evidence) among the most efficacious vaccines. Standard dose trivalent IIV3 (IIV3-SD) may prevent ILI compared with placebo, but the result was imprecise (meta-analysis: 2 RCTs, 854 participants, OR 0.39, 95%CI (0.15 to 1.02), low certainty of evidence). Any HD was associated with prevention of ILI compared with placebo (NMA: 9 RCTs, 65 658 participants, OR 0.38, 95%CI (0.15 to 0.93)). Adjuvanted quadrivalent IIV (IIV4-Adj) may be associated with the least vascular adverse events, but the results were very uncertain (NMA: eight 8 RCTs, 57 677 participants, IRR 0.18, 95%CI (0.07 to 0.43), very low certainty of evidence). RIV on all-cause mortality may be comparable to placebo (NMA: 20 RCTs, 140 577 participants, OR 1.01, 95%CI (0.23 to 4.49), low certainty of evidence)., Conclusions: This systematic review demonstrated efficacy associated with IIV3-HD and RIV vaccines in protecting older persons against LCI. RIV vaccine may reduce all-cause mortality when compared with other vaccines, but the evidence is uncertain. Differences in efficacy between influenza vaccines remain uncertain with very low to moderate certainty of evidence., Prospero Registration Number: CRD42020177357., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Rapid reviews (RRs) are produced using abbreviated methods compared with standard systematic reviews (SR) to expedite the process for decision-making. This paper provides interim guidance to support the complete reporting of RRs. Recommendations emerged from a survey informed by empirical studies of RR reporting, in addition to collective experience. RR producers should use existing, robustly developed reporting guidelines as the foundation for writing RRs: notably Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020; reporting for SRs), but also preferred reporting items for overviews of reviews (PRIOR) items (reporting for overviews of SRs) where SRs are included in the RR. In addition, a minimum set of six items were identified for RRs: three items pertaining to methods and three addressing publication ethics. Authors should be reporting what a priori-defined iterative methods were used during conduct, what distinguishes their RR from an SR, and knowledge user (eg, policymaker) involvement in the process. Explicitly reporting deviations from standard SR methods, including omitted steps, is important. The inclusion of publication ethics items reflects the predominance of non-journal published RRs: reporting an authorship byline and corresponding author, acknowledging other contributors, and reporting the use of expert peer review. As various formats may be used when packaging and presenting information to decision-makers, it is practical to think of complete reporting as across a set of explicitly linked documents made available in an open-access journal or repository that is barrier-free. We encourage feedback from the RR community of the use of these items as we look to develop a consolidated list in the development of PRISMA-RR., Competing Interests: Competing interests: BJS led the development of AMSTAR. No other authors had conflicts to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Systematic reviews (SRs) are being published at an accelerated rate. Decision-makers may struggle with comparing and choosing between multiple SRs on the same topic. We aimed to understand how healthcare decision-makers (eg, practitioners, policymakers, researchers) use SRs to inform decision-making and to explore the potential role of a proposed artificial intelligence (AI) tool to assist in critical appraisal and choosing among SRs., Methods: We developed a survey with 21 open and closed questions. We followed a knowledge translation plan to disseminate the survey through social media and professional networks., Results: Our survey response rate was lower than expected (7.9% of distributed emails). Of the 684 respondents, 58.2% identified as researchers, 37.1% as practitioners, 19.2% as students and 13.5% as policymakers. Respondents frequently sought out SRs (97.1%) as a source of evidence to inform decision-making. They frequently (97.9%) found more than one SR on a given topic of interest to them. Just over half (50.8%) struggled to choose the most trustworthy SR among multiple. These difficulties related to lack of time (55.2%), or difficulties comparing due to varying methodological quality of SRs (54.2%), differences in results and conclusions (49.7%) or variation in the included studies (44.6%). Respondents compared SRs based on the relevance to their question of interest, methodological quality, and recency of the SR search. Most respondents (87.0%) were interested in an AI tool to help appraise and compare SRs., Conclusions: Given the identified barriers of using SR evidence, an AI tool to facilitate comparison of the relevance of SRs, the search and methodological quality, could help users efficiently choose among SRs and make healthcare decisions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Trauma-informed care (TIC) is an approach to care emerging in research and in practice that involves addressing the needs of individuals with histories of trauma. The aim of this scoping review was to examine the current literature relating to TIC interventions used in pediatric mental health inpatient and residential settings. We sought to answer the following two research questions: (a) What are the TIC interventions used in pediatric inpatient and residential treatment mental healthcare settings and what are their components? and (b) What are the implementation goals and strategies used with these TIC interventions? We conducted this scoping review according to JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. We included any primary study describing a TIC intervention that was implemented at a specific site which identified and described implementation strategies used. Of 1,571 identified citations and 54 full-text articles located by handsearching, 49 met the eligibility criteria and were included, representing 21 distinct TIC interventions. We present the reported aim, ingredients, mechanism, and delivery (AIMD) of TIC interventions as well as the implementation goals and strategies used, which varied in detail, ranging from very little information to more detailed descriptions. In the context of these findings, we emphasize the complexity of TIC and of TIC interventions, and the importance of identifying and clearly reporting TIC intervention goals, intervention details, and implementation strategies. We suggest applying intervention frameworks or reporting guidelines to support clear and comprehensive reporting, which would better facilitate replication and synthesis of published TIC interventions., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Scoping reviews can identify a large number of evidence sources. This commentary describes and provides guidance on planning, conducting, and reporting large scoping reviews. This guidance is informed by experts in scoping review methodology, including JBI (formerly Joanna Briggs Institute) Scoping Review Methodology group members, who have also conducted and reported large scoping reviews. We propose a working definition for large scoping reviews that includes approximately 100 sources of evidence but must also consider the volume of data to be extracted, the complexity of the analyses, and purpose. We pose 6 core questions for scoping review authors to consider when planning, developing, conducting, and reporting large scoping reviews. By considering and addressing these questions, scoping review authors might better streamline and manage the conduct and reporting of large scoping reviews from the planning to publishing stage., Competing Interests: Declaration of competing interest A.C.T. is funded by a Tier 2 Canada Research Chair in Knowledge Synthesis. Z.M. is supported by an NHMRC investigator grant APP1195676., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The proliferation of evidence synthesis methods makes it challenging for reviewers to select the ''right'' method. This study aimed to update the Right Review tool (a web-based decision support tool that guides users through a series of questions for recommending evidence synthesis methods) and establish a common set of questions for the synthesis of both quantitative and qualitative studies (https://rightreview.knowledgetranslation.net/)., Study Design and Setting: A 2-round modified international electronic modified Delphi was conducted (2022) with researchers, health-care providers, patients, and policy makers. Panel members rated the importance/clarity of the Right Review tool's guiding questions, evidence synthesis type definitions and tool output. High agreement was defined as at least 70% agreement. Any items not reaching high agreement after round 2 were discussed by the international Project Steering Group., Results: Twenty-four experts from 9 countries completed round 1, with 12 completing round 2. Of the 46 items presented in round 1, 21 reached high agreement. Twenty-seven items were presented in round 2, with 8 reaching high agreement. The Project Steering Group discussed items not reaching high agreement, including 8 guiding questions, 9 review definitions (predominantly related to qualitative synthesis), and 2 output items. Three items were removed entirely and the remaining 16 revised and edited and/or combined with existing items. The final tool comprises 42 items; 9 guiding questions, 25 evidence synthesis definitions and approaches, and 8 tool outputs., Conclusion: The freely accessible Right Review tool supports choosing an appropriate review method. The design and clarity of this tool was enhanced by harnessing the Delphi technique to shape ongoing development. The updated tool is expected to be available in Quarter 1, 2025., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Barbara Clyne reports financial support was provided by Health Research Board. Dr Tricco (coauthor) is an Editor at the Journal of Clinical Epidemiology. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

This scoping review aims to identify and systematically review published mapping reviews to assess their commonality and heterogeneity and determine whether additional efforts should be made to standardise methodology and reporting. The following databases were searched; Ovid MEDLINE, Embase, CINAHL, PsycINFO, Campbell collaboration database, Social Science Abstracts, Library and Information Science Abstracts (LISA). Following a pilot-test on a random sample of 20 citations included within title and abstracts, two team members independently completed all screening. Ten articles were piloted at full-text screening, and then each citation was reviewed independently by two team members. Discrepancies at both stages were resolved through discussion. Following a pilot-test on a random sample of five relevant full-text articles, one team member abstracted all the relevant data. Uncertainties in the data abstraction were resolved by another team member. A total of 335 articles were eligible for this scoping review and subsequently included. There was an increasing growth in the number of published mapping reviews over the years from 5 in 2010 to 73 in 2021. Moreover, there was a significant variability in reporting the included mapping reviews including their research question, priori protocol, methodology, data synthesis and reporting. This work has further highlighted the gaps in evidence synthesis methodologies. Further guidance developed by evidence synthesis organisations, such as JBI and Campbell, has the potential to clarify challenges experienced by researchers, given the magnitude of mapping reviews published every year., (© 2024 The Authors. Research Synthesis Methods published by John Wiley & Sons Ltd.)

Background: Various studies have demonstrated gender disparities in workplace settings and the need for further intervention. This study identifies and examines evidence from randomized controlled trials (RCTs) on interventions examining gender equity in workplace or volunteer settings. An additional aim was to determine whether interventions considered intersection of gender and other variables, including PROGRESS-Plus equity variables (e.g., race/ethnicity)., Methods: Scoping review conducted using the JBI guide. Literature was searched in MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, ERIC, Index to Legal Periodicals and Books, PAIS Index, Policy Index File, and the Canadian Business & Current Affairs Database from inception to May 9, 2022, with an updated search on October 17, 2022. Results were reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension to scoping reviews (PRISMA-ScR), Sex and Gender Equity in Research (SAGER) guidance, Strengthening the Integration of Intersectionality Theory in Health Inequality Analysis (SIITHIA) checklist, and Guidance for Reporting Involvement of Patients and the Public (GRIPP) version 2 checklist. All employment or volunteer sectors settings were included. Included interventions were designed to promote workplace gender equity that targeted: (a) individuals, (b) organizations, or (c) systems. Any comparator was eligible. Outcomes measures included any gender equity related outcome, whether it was measuring intervention effectiveness (as defined by included studies) or implementation. Data analyses were descriptive in nature. As recommended in the JBI guide to scoping reviews, only high-level content analysis was conducted to categorize the interventions, which were reported using a previously published framework., Results: We screened 8855 citations, 803 grey literature sources, and 663 full-text articles, resulting in 24 unique RCTs and one companion report that met inclusion criteria. Most studies (91.7%) failed to report how they established sex or gender. Twenty-three of 24 (95.8%) studies reported at least one PROGRESS-Plus variable: typically sex or gender or occupation. Two RCTs (8.3%) identified a non-binary gender identity. None of the RCTs reported on relationships between gender and other characteristics (e.g., disability, age, etc.). We identified 24 gender equity promoting interventions in the workplace that were evaluated and categorized into one or more of the following themes: (i) quantifying gender impacts; (ii) behavioural or systemic changes; (iii) career flexibility; (iv) increased visibility, recognition, and representation; (v) creating opportunities for development, mentorship, and sponsorship; and (vi) financial support. Of these interventions, 20/24 (83.3%) had positive conclusion statements for their primary outcomes (e.g., improved academic productivity, increased self-esteem) across heterogeneous outcomes., Conclusions: There is a paucity of literature on interventions to promote workplace gender equity. While some interventions elicited positive conclusions across a variety of outcomes, standardized outcome measures considering specific contexts and cultures are required. Few PROGRESS-Plus items were reported. Non-binary gender identities and issues related to intersectionality were not adequately considered. Future research should provide consistent and contemporary definitions of gender and sex., Trial Registration: Open Science Framework https://osf.io/x8yae ., (© 2024. The Author(s).)

Objectives: Evidence-based research (EBR) is the systematic and transparent use of prior research to inform a new study so that it answers questions that matter in a valid, efficient, and accessible manner. This study surveyed experts about existing (e.g., citation analysis) and new methods for monitoring EBR and collected ideas about implementing these methods., Study Design and Setting: We conducted a cross-sectional study via an online survey between November 2022 and March 2023. Participants were experts from the fields of evidence synthesis and research methodology in health research. Open-ended questions were coded by recurring themes; descriptive statistics were used for quantitative questions., Results: Twenty-eight expert participants suggested that citation analysis should be supplemented with content evaluation (not just what is cited but also in which context), content expert involvement, and assessment of the quality of cited systematic reviews. They also suggested that citation analysis could be facilitated with automation tools. They emphasized that EBR monitoring should be conducted by ethics committees and funding bodies before the research starts. Challenges identified for EBR implementation monitoring were resource constraints and clarity on responsibility for EBR monitoring., Conclusion: Ideas proposed in this study for monitoring the implementation of EBR can be used to refine methods and define responsibility but should be further explored in terms of feasibility and acceptability. Different methods may be needed to determine if the use of EBR is improving over time., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Aims: To explore youth, caregiver and staff perspectives on their vision of trauma-informed care, and to identify and understand potential considerations for the implementation of a trauma-informed care programme in an inpatient mental health unit within a paediatric hospital., Design and Methods: We applied the Interpretive Description approach, guided by complexity theory and the Implementation Roadmap, and used Applied Thematic Analysis methods., Findings: Twenty-five individuals participated in individual or group interviews between March and June 2022, including 21 healthcare professionals, 3 youth and 1 caregiver. We identified two overarching themes. The first theme, 'Understanding and addressing the underlying reasons for distress', related to participants' understanding and vision of TIC in the current setting comprising: (a) 'Participants' understanding of TIC'; (b) 'Trauma screening and trauma processing within TIC'; (c) 'Taking "a more individualized approach"'; (d) 'Unit programming'; and (e) "Connecting to the community". The second theme, 'Factors that support or limit successful TIC implementation' comprises: (a) 'The need for a broad "cultural shift"'; (b) 'The physical environment on the unit'; and (c) 'Factors that may limit successful implementation'., Conclusion: We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of engagement with youth, caregivers and staff in trauma-informed care delivery and implementation, (b) trauma-informed care core programme components, (c) factors that may support or limit success in implementing trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration (partnering with external organizations and sectors)., Impact: When implementing TIC, there is an ongoing need to increase clarity regarding TIC interventions and implementation initiatives. Youth, caregiver and healthcare professional participants shared considerations important for planning the delivery and implementation of trauma-informed care in their setting. We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of relational engagement, (b) trauma-informed care programme components, (c) factors that may support or limit successful implementation of trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration. Organizations wishing to implement trauma-informed care should consider ongoing engagement with all relevant knowledge user groups throughout the process., Reporting Method: Standards for Reporting Qualitative Research (SRQR)., Patient or Public Contribution: The local hospital research institute's Patient and Family Advisory Committee reviewed the draft study methods and provided feedback., (© 2024 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.)

Objectives: To identify, chart and analyse the literature on recent initiatives to improve long-term care (LTC) coverage, financial protection and financial sustainability for persons aged 60 and older., Design: Rapid scoping review., Data Sources: Four databases and four sources of grey literature were searched for reports published between 2017 and 2022. After using a supervised machine learning tool to rank titles and abstracts, two reviewers independently screened sources against inclusion criteria., Eligibility Criteria: Studies published from 2017-2022 in any language that captured recent LTC initiatives for people aged 60 and older, involved evaluation and directly addressed financing were included., Data Extraction and Analysis: Data were extracted using a form designed to answer the review questions and analysed using descriptive qualitative content analysis, with data categorised according to a prespecified framework to capture the outcomes of interest., Results: Of 24 reports, 22 were published in peer-reviewed journals, and two were grey literature sources. Study designs included quasi-experimental study, policy analysis or comparison, qualitative description, comparative case study, cross-sectional study, systematic literature review, economic evaluation and survey. Studies addressed coverage based on the level of disability, income, rural/urban residence, employment and citizenship. Studies also addressed financial protection, including out-of-pocket (OOP) expenditures, copayments and risk of poverty related to costs of care. The reports addressed challenges to financial sustainability such as lack of service coordination and system integration, insufficient economic development and inadequate funding models., Conclusions: Initiatives where LTC insurance is mandatory and accompanied by commensurate funding are situated to facilitate ageing in place. Efforts to expand population coverage are common across the initiatives, with the potential for wider economic benefits. Initiatives that enable older people to access the services needed while avoiding OOP-induced poverty contribute to improved health and well-being. Preserving health in older people longer may alleviate downstream costs and contribute to financial sustainability., Competing Interests: Competing interests: LEW is the co-owner of an assisted living home., (© World Health Organization 2024. Licensee BMJ.)

Rapid reviews (RRs) are a helpful evidence synthesis tool to support urgent and emergent decision-making in healthcare. RRs involve abbreviating systematic review methods and are conducted in a condensed timeline to meet the decision-making needs of organisations or groups that commission them. Knowledge users (KUs) are those individuals, typically patient and public partners, healthcare providers, and policy-makers, who are likely to use evidence from research, including RRs, to make informed decisions about health policies, programmes or practices. However, research suggests that KU involvement in RRs is often limited or overlooked, and few RRs include patients as KUs. Existing RR methods guidance advocates involving KUs but lacks detailed steps on how and when to do so. This paper discusses the importance of involving KUs in RRs, including patient and public involvement to ensure RRs are fit for purpose and relevant for decision-making. Opportunities to involve KUs in planning, conduct and knowledge translation of RRs are outlined. Further, this paper describes various modes of engaging KUs during the review lifecycle; key considerations researchers should be mindful of when involving distinct KU groups; and an exemplar case study demonstrating substantive involvement of patient partners and the public in developing RRs. Although involving KUs requires time, resources and expertise, researchers should strive to balance 'rapid' with meaningful KU involvement in RRs. This paper is the first in a series led by the Cochrane Rapid Reviews Methods Group to further guide general RR methods., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Network meta-analyses (NMAs) have gained popularity and grown in number due to their ability to provide estimates of the comparative effectiveness of multiple treatments for the same condition. The aim of this study is to conduct a methodological review to compile a preliminary list of concepts related to bias in NMAs., Methods and Analysis: We included papers that present items related to bias, reporting or methodological quality, papers assessing the quality of NMAs, or method papers. We searched MEDLINE, the Cochrane Library and unpublished literature (up to July 2020). We extracted items related to bias in NMAs. An item was excluded if it related to general systematic review quality or bias and was included in currently available tools such as ROBIS or AMSTAR 2. We reworded items, typically structured as questions, into concepts (i.e. general notions)., Results: One hundred eighty-one articles were assessed in full text and 58 were included. Of these articles, 12 were tools, checklists or journal standards; 13 were guidance documents for NMAs; 27 were studies related to bias or NMA methods; and 6 were papers assessing the quality of NMAs. These studies yielded 99 items of which the majority related to general systematic review quality and biases and were therefore excluded. The 22 items we included were reworded into concepts specific to bias in NMAs., Conclusions: A list of 22 concepts was included. This list is not intended to be used to assess biases in NMAs, but to inform the development of items to be included in our tool., (© 2024. The Author(s).)

Objectives: Effective measurement and monitoring of health status in patients with spine-related musculoskeletal (MSK) disorders are essential for providing appropriate care and improving outcomes. Minimal clinical datasets are standardized sets of key data elements and patient-centered outcomes that can be measured and recorded during routine clinical care. Our scoping review aimed to identify and map current evidence on minimal clinical datasets for measuring and monitoring health status in patients with spine-related MSK disorders in primary and outpatient healthcare settings., Study Design and Setting: We followed the JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. MEDLINE, CINAHL, Cochrane Library, Index to Chiropractic Literature, MANTIS, ProQuest Dissertations and Theses Global, and medRxiv preprint repository were searched from database inception to August 1, 2021. Two reviewers independently screened titles and abstracts, full-text articles, and charted the evidence. Findings were synthesized and summarized descriptively., Results: After screening 5,583 citations and 301 full-text articles, 104 studies about 32 individual minimal clinical datasets were included. Most minimal clinical datasets were developed for patient populations with spine-involving inflammatory arthritis, nonspecific or degenerative spinal pain, and MSK disorders in general. The minimal clinical datasets varied substantially in terms of the author-reported time-to-complete (1-48 minutes) and the number of items (5-100 items). Fifty percent of the datasets involved healthcare professionals in their development process, and only 28% involved patients. Health domain items were most frequently linked to the components of activities and participation (43.9%) and body functions (28.6%), according to the International Classification of Functioning, Disability, and Health. There is no standardized definition of minimal clinical datasets to measure and monitor health status of patients with spine-related MSK disorders in routine clinical practice. Common core elements identified were practicality, feasibility in a busy routine practice, time efficiency, and the capability to be used across different healthcare settings., Conclusion: Due to the absence of a standard definition for minimal clinical datasets for patients with spine-related MSK disorders, there is a lack of consistency in the selection of key data elements and patient-centered outcomes that should be included. More research on the implementation and feasibility of minimal clinical datasets in routine care settings is warranted and needed. It is essential to involve all relevant partners in the development process of minimal clinical datasets to ensure successful implementation and adoption in routine primary care., Competing Interests: Declaration of competing interest A.C.T. is an editor of Journal of Clinical Epidemiology. She had no part in the editorial or peer-review process of this manuscript., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: e-Prescribing is designed to assist in facilitating safe and appropriate prescriptions for patients. Currently, it is unknown to what extent e-prescribing for opioids influences experiences and outcomes. To address this gap, a rapid scoping review was conducted., Objective: This rapid scoping review aims to (1) explore how e-prescribing has been used clinically; (2) examine the effects of e-prescribing on clinical outcomes, the patient or clinician experience, service delivery, and policy; and (3) identify current gaps in the present literature to inform future studies and recommendations., Methods: A rapid scoping review was conducted following the guidance of the JBI 2020 scoping review methodology and the World Health Organization guide to rapid reviews. A comprehensive literature search was completed by an expert librarian from inception until November 16, 2022. Three databases were electronically searched: MEDLINE (Ovid), Embase (Ovid), and Scopus (Elsevier). The search criteria were as follows: (1) e-prescribing programs targeted to the use or misuse of opioids, including those that were complemented or accompanied by clinically focused initiatives, and (2) a primary research study of experimental, quasi-experimental, observational, qualitative, or mixed methods design. An additional criterion of an ambulatory component of e-prescribing (eg, e-prescribing occurred upon discharge from acute care) was added at the full-text stage. No language limitations or filters were applied. All articles were double screened by trained reviewers. Gray literature was manually searched by a single reviewer. Data were synthesized using a descriptive approach., Results: Upon completing screening, 34 articles met the inclusion criteria: 32 (94%) peer-reviewed studies and 2 (6%) gray literature documents (1 thesis study and 1 report). All 33 studies had a quantitative component, with most highlighting e-prescribing from acute care settings to community settings (n=12, 36%). Only 1 (3%) of the 34 articles provided evidence on e-prescribing in a primary care setting. Minimal prescriber, pharmacist, and clinical population characteristics were reported. The main outcomes identified were related to opioid prescribing rates, alerts (eg, adverse drug events and drug-drug interactions), the quantity and duration of opioid prescriptions, the adoption of e-prescribing technology, attitudes toward e-prescribing, and potential challenges with the implementation of e-prescribing into clinical practice. e-Prescribing, including key features such as alerts and dose order sets, may reduce prescribing errors., Conclusions: This rapid scoping review highlights initial promising results with e-prescribing and opioid therapy management. It is important that future work explores the experience of prescribers, pharmacists, and patients using e-prescribing for opioid therapy management with an emphasis on prescribers in the community and primary care. Developing a common set of quality indicators for e-prescribing of opioids will help build a stronger evidence base. Understanding implementation considerations will be of importance as the technology is integrated into clinical practice and health systems., (©Sara J T Guilcher, Stephanie R Cimino, Mina Tadrous, Lisa M McCarthy, Jessica Riad, Andrea C Tricco, Simon Hagens, Jennifer Lien, Sukirtha Tharmalingam, Tara Gomes. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 28.12.2023.)

Chronic primary low back pain (CPLBP) is a prevalent and disabling condition that often requires rehabilitation interventions to improve function and alleviate pain. This paper aims to advance future research, including systematic reviews and randomized controlled trials (RCTs), on CPLBP management. We provide methodological and reporting recommendations derived from our conducted systematic reviews, offering practical guidance for conducting robust research on the effectiveness of rehabilitation interventions for CPLBP. Our systematic reviews contributed to the development of a WHO clinical guideline for CPLBP. Based on our experience, we have identified methodological issues and recommendations, which are compiled in a comprehensive table and discussed systematically within established frameworks for reporting and critically appraising RCTs. In conclusion, embracing the complexity of CPLBP involves recognizing its multifactorial nature and diverse contexts and planning for varying treatment responses. By embracing this complexity and emphasizing methodological rigor, research in the field can be improved, potentially leading to better care and outcomes for individuals with CPLBP., (© 2023. The Author(s).)

As commissioned by the WHO, we updated and expanded the scope of four systematic reviews to inform its (in development) clinical practice guideline for the management of CPLBP in adults, including older adults. Methodological details and results of each review are described in the respective articles in this series. In the last article of this series, we discuss methodological considerations, clinical implications and recommendations for future research., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: Evaluate benefits and harms of structured exercise programs for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline., Methods: We searched for randomized controlled trials (RCTs) in electronic databases (inception to 17 May 2022). Eligible RCTs targeted structured exercise programs compared to placebo/sham, usual care, or no intervention (including comparison interventions where the attributable effect of exercise could be isolated). We extracted outcomes, appraised risk of bias, conducted meta-analyses where appropriate, and assessed certainty of evidence using GRADE., Results: We screened 2503 records (after initial screening through Cochrane RCT Classifier and Cochrane Crowd) and 398 full text RCTs. Thirteen RCTs rated with overall low or unclear risk of bias were synthesized. Assessing individual exercise types (predominantly very low certainty evidence), pain reduction was associated with aerobic exercise and Pilates vs. no intervention, and motor control exercise vs. sham. Improved function was associated with mixed exercise vs. usual care, and Pilates vs. no intervention. Temporary increased minor pain was associated with mixed exercise vs. no intervention, and yoga vs. usual care. Little to no difference was found for other comparisons and outcomes. When pooling exercise types, exercise vs. no intervention probably reduces pain in adults (8 RCTs, SMD = - 0.33, 95% CI - 0.58 to - 0.08) and functional limitations in adults and older adults (8 RCTs, SMD = - 0.31, 95% CI - 0.57 to - 0.05) (moderate certainty evidence)., Conclusions: With moderate certainty, structured exercise programs probably reduce pain and functional limitations in adults and older people with CPLBP., (© 2023. The Author(s).)

Purpose: Evaluate benefits and harms of needling therapies (NT) for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline., Methods: Electronic databases were searched for randomized controlled trials (RCTs) assessing NT compared with placebo/sham, usual care, or no intervention (comparing interventions where the attributable effect could be isolated). We conducted meta-analyses where indicated and graded the certainty of evidence., Results: We screened 1831 citations and 109 full text RCTs, yeilding 37 RCTs. The certainty of evidence was low or very low across all included outcomes. There was little or no difference between NT and comparisons across most outcomes; there may be some benefits for certain outcomes. Compared with sham, NT improved health-related quality of life (HRQoL) (physical) (2 RCTs; SMD = 0.20, 95%CI 0.07; 0.32) at 6 months. Compared with no intervention, NT reduced pain at 2 weeks (21 RCTs; MD = - 1.21, 95%CI - 1.50; - 0.92) and 3 months (9 RCTs; MD = - 1.56, 95%CI - 2.80; - 0.95); and reduced functional limitations at 2 weeks (19 RCTs; SMD = - 1.39, 95%CI - 2.00; - 0.77) and 3 months (8 RCTs; SMD = - 0.57, 95%CI - 0.92; - 0.22). In older adults, NT reduced functional limitations at 2 weeks (SMD = - 1.10, 95%CI - 1.71; - 0.48) and 3 months (SMD = - 1.04, 95%CI - 1.66; - 0.43). Compared with usual care, NT reduced pain (MD = - 1.35, 95%CI - 1.86; - 0.84) and functional limitations (MD = - 2.55, 95%CI - 3.70; - 1.40) at 3 months., Conclusion: Based on low to very low certainty evidence, adults with CPLBP experienced some benefits in pain, functioning, or HRQoL with NT; however, evidence showed little to no differences for other outcomes., (© 2023. The Author(s).)

Purpose: To evaluate benefits and harms of transcutaneous electrical nerve stimulation (TENS) for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline., Methods: We searched for randomized controlled trials (RCTs) from various electronic databases from July 1, 2007 to March 9, 2022. Eligible RCTs targeted TENS compared to placebo/sham, usual care, no intervention, or interventions with isolated TENS effects (i.e., combined TENS with treatment B versus treatment B alone) in adults with CPLBP. We extracted outcomes requested by the WHO Guideline Development Group, appraised the risk of bias, conducted meta-analyses where appropriate, and graded the certainty of evidence using GRADE., Results: Seventeen RCTs (adults, n = 1027; adults ≥ 60 years, n = 28) out of 2010 records and 89 full text RCTs screened were included. The evidence suggested that TENS resulted in a marginal reduction in pain compared to sham (9 RCTs) in the immediate term (2 weeks) (mean difference (MD) = -0.90, 95% confidence interval  -1.54 to -0.26), and a reduction in pain catastrophizing in the short term (3 months) with TENS versus no intervention or interventions with TENS specific effects (1 RCT) (MD = -11.20, 95% CI -17.88 to -3.52). For other outcomes, little or no difference was found between TENS and the comparison interventions. The certainty of the evidence for all outcomes was very low., Conclusions: Based on very low certainty evidence, TENS resulted in brief and marginal reductions in pain (not deemed clinically important) and a short-term reduction in pain catastrophizing in adults with CPLBP, while little to no differences were found for other outcomes., (© 2023. The Author(s).)

Purpose: Evaluate benefits and harms of education/advice for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline., Methods: Electronic databases were searched for randomized controlled trials (RCTs) assessing education/advice compared with placebo/sham, usual care, or no intervention (including comparison interventions where the attributable effect of education/advice could be isolated). We conducted meta-analyses and graded the certainty of evidence., Results: We screened 2514 citations and 86 full text RCTs and included 15 RCTs. Most outcomes were assessed 3 to 6 months post-intervention. Compared with no intervention, education/advice improved pain (10 RCTs, MD = -1.1, 95% CI -1.63 to -0.56), function (10 RCTs, SMD = -0.51, 95% CI -0.89 to -0.12), physical health-related quality of life (HRQoL) (2 RCTs, MD = 24.27, 95% CI 12.93 to 35.61), fear avoidance (5 RCTs, SMD = -1.4, 95% CI -2.51 to -0.29), depression (1 RCT; MD = 2.10, 95% CI 1.05 to 3.15), and self-efficacy (1 RCT; MD = 4.4, 95% CI 2.77 to 6.03). Education/advice conferred less benefit than sham Kinesio taping for improving fear avoidance regarding physical activity (1 RCT, MD = 5.41, 95% CI 0.28 to 10.54). Compared with usual care, education/advice improved pain (1 RCT, MD = -2.10, 95% CI -3.13 to -1.07) and function (1 RCT, MD = -7.80, 95% CI -14.28 to -1.32). There was little or no difference between education/advice and comparisons for other outcomes. For all outcomes, the certainty of evidence was very low., Conclusion: Education/advice in adults with CPLBP was associated with improvements in pain, function, HRQoL, and psychological outcomes, but with very low certainty., (© 2023. The Author(s).)

Background: There is increasing evidence that co-design can lead to more engaging, acceptable, relevant, feasible, and even effective interventions. However, no guidance is provided on the specific designs and associated methods or methodologies involved in the process. We propose the development of the Preferred Components for Co-design in Research (PRECISE) guideline to enhance the consistency, transparency, and quality of reporting co-design studies used to develop complex health interventions., Objective: The aim is to develop the first iteration of the PRECISE guideline. The purpose of the PRECISE guideline is to improve the consistency, transparency, and quality of reporting on studies that use co-design to develop complex health interventions., Methods: The aim will be achieved by addressing the following objectives: to review and synthesize the literature on the models, theories, and frameworks used in the co-design of complex health interventions to identify their common elements (components, values or principles, associated methods and methodologies, and outcomes); and by using the results of the scoping review, prioritize the co-design components, values or principles, associated methods and methodologies, and outcomes to be included in the PRECISE guideline., Results: The project has been funded by the Canadian Institutes of Health Research., Conclusions: The collective results of this project will lead to a ready-to-implement PRECISE guideline that outlines a minimum set of items to include when reporting the co-design of complex health interventions. The PRECISE guideline will improve the consistency, transparency, and quality of reports of studies. Additionally, it will include guidance on how to enact or enable the values or principles of co-design for meaningful and collaborative solutions (interventions). PRECISE might also be used by peer reviewers and editors to improve the review of manuscripts involving co-design. Ultimately, the PRECISE guideline will facilitate more efficient use of new results about complex health intervention development and bring better returns on research investments., International Registered Report Identifier (irrid): PRR1-10.2196/50463., (©Sarah EP Munce, Carolyn Steele Gray, Beverley Claire Pomeroy, Mark Bayley, Kristina Marie Kokorelias, Dorothy Luong, Elaine Biddiss, Trish Cave, Peter Bragge, Carolyn A Chew-Graham, Heather Colquhoun, Ann Dadich, Katie N Dainty, Mark Elliott, Patrick Feng, Jodeme Goldhar, Clayon B Hamilton, Gillian Harvey, Monika Kastner, Anita Kothari, Joe Langley, Lianne Jeffs, Daniel Masterson, Michelle LA Nelson, Laure Perrier, John Riley, Kate Sellen, Emily Seto, Robert Simpson, Sophie Staniszewska, Vasanthi Srinivasan, Sharon E Straus, Andrea C Tricco, Kerry Kuluski. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.10.2023.)

Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work. AAV is on the editorial board of BMJ Evidence Based Medicine but was not involved with the peer review process or decision to publish.

Objective: We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases., Methods: Electronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty., Results: Of 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case-control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty., Conclusions: Evidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base., Competing Interests: Competing interests: BH has previously received honoraria from Eversana for methodologic advice related to the conduct of systematic reviews and meta-analysis. All remaining authors have no competing interests to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Chronic disease management (CDM) through sustained knowledge translation (KT) interventions ensures long-term, high-quality care. We assessed implementation of KT interventions for supporting CDM and their efficacy when sustained in older adults., Methods: Design: Systematic review with meta-analysis engaging 17 knowledge users using integrated KT., Eligibility Criteria: Randomized controlled trials (RCTs) including adults (> 65 years old) with chronic disease(s), their caregivers, health and/or policy-decision makers receiving a KT intervention to carry out a CDM intervention for at least 12 months (versus other KT interventions or usual care)., Information Sources: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from each database's inception to March 2020., Outcome Measures: Sustainability, fidelity, adherence of KT interventions for CDM practice, quality of life (QOL) and quality of care (QOC). Data extraction, risk of bias (ROB) assessment: We screened, abstracted and appraised articles (Effective Practice and Organisation of Care ROB tool) independently and in duplicate., Data Synthesis: We performed both random-effects and fixed-effect meta-analyses and estimated mean differences (MDs) for continuous and odds ratios (ORs) for dichotomous data., Results: We included 158 RCTs (973,074 participants [961,745 patients, 5540 caregivers, 5789 providers]) and 39 companion reports comprising 329 KT interventions, involving patients (43.2%), healthcare providers (20.7%) or both (10.9%). We identified 16 studies described as assessing sustainability in 8.1% interventions, 67 studies as assessing adherence in 35.6% interventions and 20 studies as assessing fidelity in 8.7% of the interventions. Most meta-analyses suggested that KT interventions improved QOL, but imprecisely (36 item Short-Form mental [SF-36 mental]: MD 1.11, 95% confidence interval [CI] [- 1.25, 3.47], 14 RCTs, 5876 participants, I 2  = 96%; European QOL-5 dimensions: MD 0.01, 95% CI [- 0.01, 0.02], 15 RCTs, 6628 participants, I 2  = 25%; St George's Respiratory Questionnaire: MD - 2.12, 95% CI [- 3.72, - 0.51] 44 12 RCTs, 2893 participants, I 2  = 44%). KT interventions improved QOC (OR 1.55, 95% CI [1.29, 1.85], 12 RCTS, 5271 participants, I 2  = 21%)., Conclusions: KT intervention sustainability was infrequently defined and assessed. Sustained KT interventions have the potential to improve QOL and QOC in older adults with CDM. However, their overall efficacy remains uncertain and it varies by effect modifiers, including intervention type, chronic disease number, comorbidities, and participant age., Systematic Review Registration: PROSPERO CRD42018084810., (© 2023. The Author(s).)

Introduction: Rapid systematic reviews (RRs) have the potential to provide timely information to decision-makers, thus directly impacting healthcare. However, consensus regarding the most efficient approaches to performing RRs and the presence of several unaddressed methodological issues pose challenges. With such a large potential research agenda for RRs, it is unclear what should be prioritised., Objective: To elicit a consensus from RR experts and interested parties on what are the most important methodological questions (from the generation of the question to the writing of the report) for the field to address in order to guide the effective and efficient development of RRs., Methods and Analysis: An eDelphi study will be conducted. Researchers with experience in evidence synthesis and other interested parties (eg, knowledge users, patients, community members, policymaker, industry, journal editors and healthcare providers) will be invited to participate. The following steps will be taken: (1) a core group of experts in evidence synthesis will generate the first list of items based on the available literature; (2) using LimeSurvey, participants will be invited to rate and rank the importance of suggested RR methodological questions. Questions with open format responses will allow for modifications to the wording of items or the addition of new items; (3) three survey rounds will be performed asking participants to re-rate items, with items deemed of low importance being removed at each round; (4) a list of items will be generated with items believed to be of high importance by ≥75% of participants being included and (5) this list will be discussed at an online consensus meeting that will generate a summary document containing the final priority list. Data analysis will be performed using raw numbers, means and frequencies., Ethics and Dissemination: This study was approved by the Concordia University Human Research Ethics Committee (#30015229). Both traditional, for example, scientific conference presentations and publication in scientific journals, and non-traditional, for example, lay summaries and infographics, knowledge translation products will be created., Competing Interests: Competing interests: The authors alone are responsible for the views expressed in this paper and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated. The authors have no conflicts of interest to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To demonstrate how the 22-item Patient Engagement in Research Scale (PEIRS-22) can be used to develop recommendations for improving the meaningfulness of patient engagement., Study Design and Setting: PEIRS-22 previously captured quantitative evaluation data from 15 patient partners in a self-study of the Strategy for Patient-Oriented Research (SPOR) Evidence Alliance. Guided by deliberative dialogue, the current study involved 3 steps: (1) In-depth analysis and interpretation of the PEIRS-22 data produced a lay evidence summary with identified areas for improvement of meaningful engagement; (2) A 3-hour virtual workshop with patient partners and researchers generated initial recommendations; and (3) In two successive post-workshop surveys, ratings by workshop invitees led to consensus on the recommendations., Results: Twenty-five participants attended the workshops and dialogued on 8 areas for improvement identified from the PEIRS-22 data. Twenty-eight unique initial recommendations led to consensus on 14 key recommendations organized across 4 categories: setting expectations for all team members, building trust and ongoing communication, providing opportunities to enhance learning and to develop skills, and acknowledging contributions of patient partners., Conclusion: Using PEIRS-22 data within a deliberate dialogue elucidated 14 actionable recommendations to support ongoing improvement of patient engagement at SPOR Evidence Alliance, a pan-Canadian health research initiative., Competing Interests: Declaration of Competing Interest This program evaluation study was conducted through the Strategy for Patient-Oriented Research (SPOR) Evidence Alliance, which is supported by the Canadian Institutes of Health Research (CIHR) under the SPOR initiative (grant number GSR-154442). Dr. Andrea Tricco holds a Tier 2 Canada Research Chair in Knowledge Synthesis. Dr. Linda Li holds a Tier 2 Canada Research Chair in Patient-oriented Knowledge Translation and the Harold Robinson/Arthritis Society Chair in Arthritic Diseases., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Data extraction is a prerequisite for analyzing, summarizing, and interpreting evidence in systematic reviews. Yet guidance is limited, and little is known about current approaches. We surveyed systematic reviewers on their current approaches to data extraction, opinions on methods, and research needs., Study Design and Setting: We developed a 29-question online survey and distributed it through relevant organizations, social media, and personal networks in 2022. Closed questions were evaluated using descriptive statistics, and open questions were analyzed using content analysis., Results: 162 reviewers participated. Use of adapted (65%) or newly developed extraction forms (62%) was common. Generic forms were rarely used (14%). Spreadsheet software was the most popular extraction tool (83%). Piloting was reported by 74% of respondents and included a variety of approaches. Independent and duplicate extraction was considered the most appropriate approach to data collection (64%). About half of respondents agreed that blank forms and/or raw data should be published. Suggested research gaps were the effects of different methods on error rates (60%) and the use of data extraction support tools (46%)., Conclusion: Systematic reviewers used varying approaches to pilot data extraction. Methods to reduce errors and use of support tools such as (semi-)automation tools are top research gaps., Competing Interests: Declaration of competing interest Andrea Tricco is Co-Editor-in-Chief of the JCE., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Demand for rapid evidence-based syntheses to inform health policy and systems decision-making has increased worldwide, including in low- and middle-income countries (LMICs). To promote use of rapid syntheses in LMICs, the WHO's Alliance for Health Policy and Systems Research (AHPSR) created the Embedding Rapid Reviews in Health Systems Decision-Making (ERA) Initiative. Following a call for proposals, four LMICs were selected (Georgia, India, Malaysia and Zimbabwe) and supported for 1 year to embed rapid response platforms within a public institution with a health policy or systems decision-making mandate., Methods: While the selected platforms had experience in health policy and systems research and evidence syntheses, platforms were less confident conducting rapid evidence syntheses. A technical assistance centre (TAC) was created from the outset to develop and lead a capacity-strengthening program for rapid syntheses, tailored to the platforms based on their original proposals and needs as assessed in a baseline questionnaire. The program included training in rapid synthesis methods, as well as generating synthesis demand, engaging knowledge users and ensuring knowledge uptake. Modalities included live training webinars, in-country workshops and support through phone, email and an online platform. LMICs provided regular updates on policy-makers' requests and the rapid products provided, as well as barriers, facilitators and impacts. Post-initiative, platforms were surveyed., Results: Platforms provided rapid syntheses across a range of AHPSR themes, and successfully engaged national- and state-level policy-makers. Examples of substantial policy impact were observed, including for COVID-19. Although the post-initiative survey response rate was low, three quarters of those responding felt confident in their ability to conduct a rapid evidence synthesis. Lessons learned coalesced around three themes - the importance of context-specific expertise in conducting reviews, facilitating cross-platform learning, and planning for platform sustainability., Conclusions: The ERA initiative successfully established rapid response platforms in four LMICs. The short timeframe limited the number of rapid products produced, but there were examples of substantial impact and growing demand. We emphasize that LMICs can and should be involved not only in identifying and articulating needs but as co-designers in their own capacity-strengthening programs. More time is required to assess whether these platforms will be sustained for the long-term., (© 2023. The Author(s).)