Journal of Clinical Epidemiology最新文献

{"title":"Living evidence syntheses in practice: methodology, standards, dissemination, and publication challenges. Paper 1: introduction-are living evidence syntheses truly \"living\"?","authors":"Ariadna Auladell-Rispau, Andrés Gempeler, Josefina Bendersky, Elisa Gutiérrez-Gómez, Francisca Verdugo-Paiva, Laura Trujillo, Camila Ávila, Gabriel Rada, Gerard Urrútia, María Ximena Rojas Reyes","doi":"10.1016/j.jclinepi.2026.112531","DOIUrl":"10.1016/j.jclinepi.2026.112531","url":null,"abstract":"<p><strong>Background and objective: </strong>The Living Evidence Synthesis in Practice series is based on a comprehensive literature-based survey that examines how living evidence syntheses (LESs) have been defined, implemented, reported, and updated over time. This introductory paper aims to introduce key concepts of living evidence and describe the characteristics of baseline syntheses and subsequent updates, focusing on question types, methodological features, and update trends.</p><p><strong>Methods: </strong>We conducted a methodological survey of LES, defined as evidence synthesis products (eg, systematic reviews, meta-analyses, network meta-analyses, rapid reviews, and overviews of reviews) that explicitly adopted a living evidence approach. An LES was defined as comprising a baseline synthesis report (BSR) and subsequent update reports (UDRs) and/or evidence surveillance reports (ESRs). Eligible LES were identified through comprehensive searches of the Epistemonikos database, gray literature, and organizational repositories. Identified LES were prospectively tracked from March 2022 to January 2025. Data were extracted independently in duplicate using a standardized form and analyzed descriptively to characterize baseline features, update patterns, and methodological practices over time.</p><p><strong>Results: </strong>Searches conducted up to March 2022 identified 1730 records, with 28 additional records located through manual searches. After screening and linking related references, 119 LES were included. All LES were monitored for 2 years to identify further updates. By January 2025, 123 additional reports had been identified, yielding a final dataset of 119 BSRs, 160 UDRs, and 41 ESRs. Overall, 49 LES (41.2%) produced at least 1 UDR or ESR during follow-up. The median number of updates per LES was 1 for UDRs (inter quartil range 1-4) and 3 for ESRs (inter quartile range 2-8); only three LESs (2.5%) produced both. Most baseline syntheses addressed intervention questions (64.7%), followed by prognosis (12.6%), epidemiology (12.6%), and diagnosis (9.2%). Most were labeled as living systematic reviews or living meta-analyses (86.6%), but only 32 (26.9%) cited references supporting the living approach.</p><p><strong>Conclusion: </strong>The living evidence approach is increasingly used, particularly for intervention questions. However, maintaining and consistently reporting these reviews remains challenging, as fewer than half were updated over 2 years. Stronger methodological and reporting standards are needed to ensure LES remain current, credible, and useful for decision-making.</p><p><strong>Plain language summary: </strong>LESs are secondary research studies designed to stay continuously up to date as new information becomes available. This type of review became especially popular during the COVID-19 pandemic, when health recommendations needed to change quickly based on new research. To better understand how LES are developed and mai","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112531"},"PeriodicalIF":5.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149065763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESIC Series, Paper 5: Safe and responsible use of AI in evidence synthesis: Recommendations from the Evidence Synthesis Infrastructure Collaborative (ESIC) Working Group 3.","authors":"Ashrita Saran, Malcolm Macleod","doi":"10.1016/j.jclinepi.2026.112520","DOIUrl":"10.1016/j.jclinepi.2026.112520","url":null,"abstract":"<p><strong>Background and objectives: </strong>The increasing integration of AI Digital Evidence Synthesis Tools (AI-DEST) presents both opportunities and challenges. Concerns regarding ethical implications, biases in AI algorithms, and disparities in access to high-quality evidence necessitate a structured approach to ensure that AI is used responsibly and effectively. This paper aims to identify and prioritize actionable, system-level solutions for the safe and responsible use of artificial intelligence (AI) in evidence synthesis.</p><p><strong>Methods: </strong>The group employed a systematic approach, guided by the SHOW ME the Evidence Consensus framework. The framework that emphasizes transparency, stakeholder engagement, and iterative validation across the evidence lifecycle through structured scoping exercise comprising literature review, stakeholder survey, expert interviews, and iterative group discussions. This was a two-phase process: the first phase focused on problem identification through literature reviews, surveys, and stakeholder interviews, while the second phase concentrated on identifying and prioritizing potential solutions. A total of 50 solutions were initially proposed, which were then refined through a structured prioritization process based on criteria such as innovation, feasibility, and potential impact.</p><p><strong>Results: </strong>The group identified several key solutions, including the development of an open-source Evidence Synthesis Studio that integrates various DESTs and a Comprehensive Evidence Synthesis Plug-In Architecture-an interoperable framework for the validation, benchmarking, and integration of AI tools. The group also proposed engaging key interest holders, including evidence synthesis practitioners, policymakers and tool developers, alongside transparency-oriented public engagement and iterative, citizen-informed design.</p><p><strong>Conclusion: </strong>The recommendations from Working Group 3 provide a comprehensive framework for the responsible use of AI-DEST. By fostering collaboration, transparency, and inclusivity, these solutions aim to improve the efficiency of evidence synthesis, mitigate bias, and promote ethical AI use, while addressing the challenges faced by underrepresented communities. In doing so, they strengthen evidence synthesis as a public good, ensuring that high-quality evidence is accessible to all, regardless of background or resources, particularly in the Global South.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112520"},"PeriodicalIF":5.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149065785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESIC Series: Paper 1 Introduction to the Evidence Synthesis Infrastructure Collaborative (ESIC) Planning Process Series.","authors":"Z Jordan, F Campbell, P Bragge","doi":"10.1016/j.jclinepi.2026.112518","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112518","url":null,"abstract":"<p><p>The 21st century has seen exponential growth in evidence synthesis production, yet the global evidence ecosystem remains fragmented and inconsistently resourced, leaving persistent gaps that hamper effective responses to critical global challenges. In 2025, the Evidence Synthesis Infrastructure Collaborative (ESIC) was established to conceptualise, design and support a sustainable, coordinated global infrastructure for living evidence synthesis. Bringing together multilaterals, citizen-serving NGOs, funders, evidence producers, methodologists and policymakers, the ESIC planning process adopted a participatory, transparent co-design approach across five thematic working groups and a governance planning group, culminating in the June 2025 Cape Town Consensus Meeting and the development of the ESIC Roadmap. This paper introduces a series describing the process and recommendations arising from the ESIC planning phase, situating the initiative within the broader history of efforts to translate evidence into policy and practice. It outlines the origins, structure and governance of the planning process and sets out the purpose of the accompanying paper series: to guide future investment in evidence synthesis infrastructure and to provide a historical record of this phase in its development.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112518"},"PeriodicalIF":5.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149065794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESIC series, Paper 11: Citizen engagement in evidence synthesis - Recommendations from the Evidence Synthesis Infrastructure Collaborative.","authors":"Maureen Smith, Richard Morley, Ndi Euphrasia Ebai-Atuh, Michelle Hamilton-Page","doi":"10.1016/j.jclinepi.2026.112527","DOIUrl":"10.1016/j.jclinepi.2026.112527","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Aim: &lt;/strong&gt;To describe how citizen engagement was integrated into the Evidence Synthesis Infrastructure Collaborative (ESIC) planning process, assess its influence on key outputs, and reflect on the process and the implications for embedding meaningful citizen involvement in global evidence synthesis systems.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background and objectives: &lt;/strong&gt;Citizen engagement is increasingly recognized by citizens, policy makers, funders, and evidence producers as essential for ensuring that evidence synthesis is relevant, legitimate, and reflective of public priorities. Despite an established history and growing frameworks supporting engagement, its application across global evidence ecosystems remains inconsistent. The ESIC programme sought to optimize the future of evidence synthesis, and citizens were included as key interest holders from the outset. As the process unfolded, the scope and ambition of citizen engagement expanded substantially, revealing both opportunities and structural challenges within the evidence ecosystem.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Four citizen representatives participated across working groups and governance planning, later forming a dedicated citizen leadership group. Engagement methods included participation in planning meetings, review of draft documents, key informant interviews, collaboration with working group cochairs, and leadership within a series of citizen-focused global webinars. Citizen representatives also engaged in in-person meetings where they facilitated sessions and supported diverse citizen participation. Consultation with a wider network of citizen leaders and nongovernmental organization (NGOs) shaped the iterative development of the Citizens' Call to Action.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Citizen input rapidly exceeded the original remit and catalyzed major shifts within ESIC. A Statement of Principles and subsequently the Citizens' Call to Action were codeveloped, widely circulated and refined, and strongly influenced the design of the Cape Town Consensus meeting and the final ESIC Roadmap. Citizen insights also informed the statement delivered to the United Nations on strengthening equitable evidence systems. The eventual US $126 million funding commitment and foundational arrangements announced by ESIC funders explicitly recognized citizens as essential partners, including representation in future coordination structures. Citizen-focused commitments are evident throughout the ESIC Roadmap and Cape Town Consensus Charter.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;As one of eight categories of interest holders in ESIC, citizens are often at the bottom of asymmetry of knowledge and power and most at risk of being left out of considerations or victims of tokenism. Further, with significant diversity and no global \"peak body\" to represent them, citizens are a critical and complex category of interest holders. Meaningfully embedding citizen engagement within evidence synthesis infrastru","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112527"},"PeriodicalIF":5.8,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149041845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESIC series, Paper 10: Early and mid-career researchers as coleaders in global evidence ecosystems - A commentary on lessons from the Evidence Synthesis Infrastructure Collaborative.","authors":"Aisha Naz Ansari, Claudia Alarcón-López, Getahun Fetensa, Nain Mirabel Yuh, Clarice Panyin Nyan, Kerry Waddell, Ermias Woldie, Ndi Euphrasia Ebai-Atuh, Alma Cristal Hernández Mondragón, Tiago Siqueira, Ana Beatriz Pizarro","doi":"10.1016/j.jclinepi.2026.112522","DOIUrl":"10.1016/j.jclinepi.2026.112522","url":null,"abstract":"<p><strong>Objectives: </strong>To reflect on the contributions and experiences of early- and mid-career researchers (EMCRs) within the Evidence Synthesis Infrastructure Collaborative (ESIC), and to examine how their participation can inform more equitable global evidence ecosystems.</p><p><strong>Study design and setting: </strong>This commentary draws on the authors' direct involvement as EMCR members and coleads in ESIC working groups, the Cape Town Consensus process, and the Inclusive Leadership Programme. We synthesized shared experiences across regions and sectors to identify recurring opportunities, barriers, and implications for future implementation.</p><p><strong>Results: </strong>EMCRs contributed substantively to ESIC's technical and strategic outputs, including working group reports, consensus discussions, and proposals related to equity, governance, and innovation. Their experiences highlighted intersecting challenges, including limited mentorship, career precarity, uneven digital access, and structural inequities that particularly affect researchers in low- and middle-income countries. These reflections suggest that meaningful EMCR engagement requires more than participation alone; it depends on institutionalized leadership roles, equitable funding, mentorship, and sustained capacity-sharing structures.</p><p><strong>Conclusion: </strong>ESIC demonstrates that EMCRs can serve as cocreators of global evidence initiatives when deliberate space is made for their leadership. Embedding EMCRs in governance, innovation, and capacity-building efforts will be essential to building a more inclusive, globally representative, and equitable evidence ecosystem.</p><p><strong>Plain language summary: </strong>Early- and mid-career researchers are often invited into global research initiatives, but they are not always given real opportunities to lead. In this commentary, we describe how EMCRs contributed to the Evidence Synthesis Infrastructure Collaborative and what helped or hindered their participation. Our experience shows that young and mid-career researchers, especially those from underrepresented regions, can strengthen global evidence systems when they are supported through mentorship, funding, leadership opportunities, and inclusive governance.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112522"},"PeriodicalIF":5.8,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESIC series, Paper 2: Applying the Double diamond model and codesign principles to the Evidence Synthesis Infrastructure Collaborative (ESIC) planning process.","authors":"Zoe Jordan, John N Lavis, Laurenz Mahlanza-Langer, Rhona Mijumbi-Deve, Karla Soares-Weiser","doi":"10.1016/j.jclinepi.2026.112519","DOIUrl":"10.1016/j.jclinepi.2026.112519","url":null,"abstract":"<p><strong>Background and objectives: </strong>The production and use of evidence for decision-making remains fragmented, inefficient, and inequitable. The Evidence Synthesis Infrastructure Collaborative (ESIC) planning process builds on the Global Evidence Commission and the SHOW ME the Evidence features. It was launched in late 2024 to strengthen collaboration across the evidence ecosystem. The objective was to describe the methodology behind the ESIC planning process, including the strategies used to make it open and equitable.</p><p><strong>Methods: </strong>Over 6 months in 2025, the Double Diamond model was combined with co-design principles within a convergence research framework. An open call drew 382 expressions of interest, and 145 participants were recruited across 6 groups. Groups were balanced by geography, sector, interest holder category, language, career stage, and gender. The four stages were mapped to specific activities: discover (capability mapping), define (capability maturity assessment), develop (solution ideation), and deliver (prioritization using an impact-effort matrix with equity and legitimacy lenses). Interest holder and open consultations informed each stage, and a parallel costing stream modeled what implementation would require.</p><p><strong>Results: </strong>Of the participants, 52% were from the Global South and 69% from sectors other than health. Capability varied considerably across regions, sectors, and resource settings. There were gaps in data sharing, artificial intelligence governance, and sustainable capacity strengthening. Prioritization separated quick wins from long-term, high-impact initiatives, and both were brought together in the ESIC Roadmap and the Cape Town Consensus Charter.</p><p><strong>Conclusion: </strong>Combining the Double Diamond model with co-design and convergence research gave ESIC a rigorous, adaptable planning methodology. Other global collaborations tackling complex societal challenges could use the same approach.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112519"},"PeriodicalIF":5.8,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149026596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Capacity-related exclusions in clinical trial protocols are common, with limited assessment and almost no planning for capacity loss.","authors":"Maeve McGovern, Amy M Russell, Frances Shiely","doi":"10.1016/j.jclinepi.2026.112534","DOIUrl":"10.1016/j.jclinepi.2026.112534","url":null,"abstract":"<p><strong>Background and objective: </strong>People who are assumed to have impaired decision-making capacity continue to be under-served in clinical research, despite legislation aimed at supporting their inclusion. Previous studies have highlighted the routine exclusion of individuals with intellectual disabilities or cognitive impairments, but little is known about how capacity-related decisions are documented at the protocol stage. This study examines how clinical trial protocols describe the inclusion or exclusion of individuals with impaired capacity, the assessment of capacity, and any plans for participants who might lose capacity during a trial.</p><p><strong>Methods: </strong>A structured content analysis was conducted on 500 clinical trial protocols selected from a larger dataset of 824 protocols previously identified for another study. Protocols were screened in reverse chronological order until the target number was reached. Extraction focused on capacity-related eligibility criteria, who conducted capacity assessments, any mention of training of assessors, and procedures for participants who might lose capacity. Descriptive statistics were used to summarise findings.</p><p><strong>Results: </strong>Of the 500 trial protocols reviewed, 214 (43%) made direct eligibility decisions based on decision-making capacity, and a further 92 (18%) referenced capacity indirectly through informed consent requirements, totalling 306 protocols (61%) with capacity-related criteria. Only 53 protocols (53/306, 17%) described how capacity would be assessed, 28 of these 53 identified who would conduct the assessment, and just two mentioned any assessor training. Most assessors were non-clinical staff. Just three protocols (1%) included plans for participants who might lose capacity during the study.</p><p><strong>Conclusion: </strong>This study demonstrates that capacity-related exclusions are common in clinical trial protocols, yet the processes behind these decisions are poorly documented. The lack of detail regarding assessors, training, and loss-of-capacity planning raises concerns about transparency and inclusion. Strengthening transparency and guidance at the protocol stage could help ensure that individuals with impaired or fluctuating capacity are not unethically or systematically excluded from research.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112534"},"PeriodicalIF":5.8,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Harms were rarely specified or reported in public health randomized trials: a meta-epidemiological study.","authors":"Daniel Shaughnessy, Kevin Naaman, Ashma Krishan, Aaron Beckwith, Riaz Qureshi, Tianjing Li","doi":"10.1016/j.jclinepi.2026.112530","DOIUrl":"10.1016/j.jclinepi.2026.112530","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To characterize harms specification, harms reporting, concordance between specified and reported harms, transparency about harms reporting criteria, and equity-related harms considerations in randomized controlled trials (RCTs) of public health interventions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Study design and setting: &lt;/strong&gt;We conducted a meta-epidemiological study of 100 RCTs of public health interventions whose primary full-text reports were published in 2023 and indexed in PubMed. Using the publication and publicly linked documents (registrations, protocols, and supplements), we assessed harms specification, harms reporting, concordance, transparency of reporting criteria, and whether reported harms were grouped by PROGRESS-Plus equity-related factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Only 25% (25/100) of trials specified at least one harm, and 23% (23/100) reported any harms, whereas 72% (72/100) neither specified nor reported harms. Among 28 trials that either specified or reported harms, 12 (43%) reported all specified harms, 8 (29%) reported only a subset, and 8 (29%) showed other discordance. No trial specified harms reporting criteria, and none reported harms using identifiable criteria. Trials with a registry listing and those with an identified protocol had higher odds of harms specification compared with trials without a registry or protocol (odds ratio [OR] = 4.7 [95% CI: 1.5, 14.3] and OR = 3.9 [1.5, 10.1], respectively); trials testing pharmacological interventions also showed higher odds of specification compared with other intervention types (OR = 9.8 [1.9, 49.9]). Similarly, harms reporting was higher in trials with a registry or protocol (OR = 4.0 [1.3, 12.4] and OR = 3.8 [1.4, 10.0], respectively). Although 89% of trial reports considered at least one equity-related factor among participant characteristics, none reported harms stratified by these factors. Compared with a parallel biomedical sample, public health RCTs specified and reported harms far less often.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Most public health RCTs in this sample did not publicly specify or report harms. Prespecifying how harms will be assessed and fully reporting the findings would better support decisions about adopting, modifying, or expanding public health programs. Because the sample included 100 public health RCTs and harms-related outcomes were sparse, subgroup findings should be interpreted as exploratory.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;Randomized trials of public health interventions are often used to guide decisions about programs, policies, and preventive strategies. These trials should also help identify possible harms, including unintended or inequitable consequences. We included 100 randomized trials published in 2023 that evaluated public health interventions. Most neither clearly stated which harms they planned to measure nor reported harms results. Trials with a registry listing or study protocol were more lik","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112530"},"PeriodicalIF":5.8,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149026641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESIC Series: Paper 12 Reflections on the ESIC Process and Findings.","authors":"Fiona Campbell, Jeremy M Grimshaw, Solange Durao, Maureen Smith, Peter Bragge, Ashrita Saran, Malcolm MacLeod","doi":"10.1016/j.jclinepi.2026.112523","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112523","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112523"},"PeriodicalIF":5.8,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149018774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESIC series: paper 8. Governance Principles and Considerations: Evidence Synthesis Infrastructure Collaborative Governance Planning Group.","authors":"Andrea Ordóñez Llanos, Paul Flowerdew, James Keeley, Christine Chang, Andrea Cook, Emmanuel Effa, Ismael Kawooya, Isabel Fletcher, Anne-Claire Luzot, Enrique Mendizabal, Isabelle Mercier, Alma Cristal Hernández Mondragón, Shaheen Motala-Timol, Bianca Pilla, Andrew S Pullin, Arash Rashidian, Poya Saffari, Maureen Smith, Birte Snilstveit, Ruth Stewart, Ligia Teixeira, Ngem Bede Yong, Jeremy M Grimshaw, Joseph L Mathew","doi":"10.1016/j.jclinepi.2026.112528","DOIUrl":"10.1016/j.jclinepi.2026.112528","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To develop guiding principles and governance options for the Evidence Synthesis Infrastructure Collaborative (ESIC) to ensure its effectiveness, legitimacy, and sustainability.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Study design and setting: &lt;/strong&gt;ESIC was established with Wellcome Trust funding to strengthen global evidence synthesis infrastructure and foster collaboration among researchers, funders, policymakers, and citizens. The ESIC Governance Planning Group (GPG) was tasked with designing a governance framework (during a 6-month consultative phase) despite uncertainty about ESIC's future structure and functions. The GPG adopted a broad interpretation of \"governance\", focusing on principles, potential functions, and high-level models rather than prescriptive structures. GPG activities included weekly meetings, online surveys, iterative drafting, external consultations, and an environmental scan of governance models in global nonprofit organizations. Insights were synthesized through 4 stage reports and discussions during a face-to-face meeting at the end of the consultative phase.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The GPG formulated guiding principles emphasizing equity, transparency, agility, and subsidiarity. A 4-quadrant framework was developed to classify ESIC functions: Connector (advocacy and partnerships), Participatory Platforms (inclusive engagement), Core Infrastructure (standards and tools), and Engine Rooms (regional technical support). Four governance models were assessed: federated, membership-based, flexible partnership, and rotational leadership. Two options were finally recommended: (1) a centralized shared-support body delivering Connector functions and coordinating other quadrants, or (2) a smaller network body with limited Connector roles. Both options were associated with modest costs vis-à-vis ESIC's projected budget.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Robust ESIC governance is critical to address inequities in the global evidence ecosystem. The GPG recommends phased implementation of a central support body alongside decentralized structures, guided by subsidiarity and inclusivity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;The Governance Planning Group (GPG) developed principles and governance options for the Evidence Synthesis Infrastructure Collaborative (ESIC). For this, the GPG first considered the potential functions and roles of ESIC, and then developed broad governance principles. These emphasized equity, transparency, agility, and subsidiarity. A 4-quadrant framework was developed to classify ESIC functions as Connector (for advocacy and partnerships), Participatory Platforms (for inclusive engagement), Core Infrastructure (for standards and tools), and Engine Rooms (for regional technical support). Four governance models were explored, and finally 2 options were recommended viz. (1) a centralized shared-support body delivering Connector functions and coordinating other quadrants, or (2) a smaller n","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112528"},"PeriodicalIF":5.8,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149018800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}