Background: Biomedical funders are increasingly introducing requirements for research data management (RDM) and data sharing to promote transparency and reproducibility. However, expectations for Data Management and Sharing Plans (DMSPs) and data sharing are heterogeneous and may create uncertainty and an administrative burden for researchers. Objective: In this study, we aimed to: (1) identify DMSP and data sharing requirements from biomedical funders; (2) identify how these requirements are evaluated, monitored, and supported; (3) identify existing DMSP templates used by funders; and (4) compare and assess the existing required elements for the DMSPs and how they were developed. Design: We conducted a scoping review using the Joanna Briggs Institute approach. We searched websites of 287 biomedical funders (private, philanthropic, and hybrid funders) listed on www.healthresearchfunders.org (March-August 2024) for policies, guidelines, templates, or general guidance related to RDM and data sharing. Screening and data extraction were conducted in duplicate, and data were analyzed descriptively and thematically. Results: Of 287 funders screened, 264 were eligible, and 196 documents from 84 funders were included. Sixty-five funders (25%) have explicit DMSP expectations, 76 (29%) expect data sharing, and 31 (12%) cover RDM costs. Expectations were more common among public funders (63% DMSP; 66% data sharing) than philanthropic funders (10% and 15% respectively). Regionally, requirements were most frequent in Asia (40%) and North America (32%). Nearly half of funders with DMSP policies described evaluation (49%) or monitoring (43%) processes, but approaches varied. Where expected, templates or guidance were common (86%), but the level of detail and the number of required elements differed widely. Conclusions: Our results show that biomedical funders’ expectations for DMSPs and data sharing by researchers are expanding but remain inconsistent, with considerable variation in evaluation, monitoring, and guidance. While our analysis relied on publicly available documents and did not include commercial funders, the findings highlight the need for greater harmonization, participatory template development, and clearer monitoring processes to reduce the burden on researchers and improve the impact of the policies on open and reproducible science.
Abstract Background Artificial intelligence chatbots (AICs), as a form of generative artificial intelligence (AI), are increasingly being considered for use in scholarly peer review to assist with tasks such as identifying methodological issues, verifying references, and improving language clarity. Despite these potential benefits, concerns remain regarding their reliability, ethical implications, and transparency. Evidence on how medical journal peer reviewers perceive the role and impact of AICs is limited. This study explored reviewers’ familiarity with AICs, perceived benefits and challenges, ethical concerns, and anticipated future roles in peer review. Methods We conducted a cross-sectional online survey of medical journal peer reviewers. Corresponding author information was extracted from MEDLINE-indexed articles added to PubMed within a two-month period using an R-based approach. A total of 72,851 authors were invited via email to participate; those who self-identified as peer reviewers were eligible. The 29-item survey assessed familiarity with AICs and perceptions of their benefits and limitations in peer review. The survey was administered via SurveyMonkey from April 28 to June 16, 2025, with two reminder emails sent during the data collection period. Results A total of 1,260 respondents completed the survey. Most participants were familiar with AICs (86.2%) and had used tools such as ChatGPT for general purposes (87.7%), but the majority had not used AICs for peer review (70.3%). Most respondents reported that their institutions do not provide training on AIC use in peer review (69.5%), although many expressed interest in such training (60.7%). Perceptions of AIC benefits were mixed, while concerns were widely shared, particularly regarding potential algorithmic bias (80.3%) and issues related to trust and user acceptance (73.3%). Conclusions While familiarity with AICs is high among medical journal peer reviewers, their use in peer review remains limited. There is clear interest in training and guidance, however, concerns related to ethics, data privacy, and research integrity persist and should be addressed before broader implementation.
Objectives Systematic reviews (SRs) provide the highest level of evidence for clinical and policy decision-making but quickly become outdated as new studies emerge. Updated systematic reviews (USRs) and living systematic reviews (LSRs) offer 2 frameworks to maintain currency; however, statistical approaches for repeated updates of pairwise meta-analyses (PMAs) and network meta-analyses (NMA) remain heterogeneous. This scoping review aimed to identify, categorize, and summarize existing methods for conducting updated meta-analyses (primarily PMAs and, subject to available evidence, NMAs) in the context of USRs and LSRs, highlighting their properties, as well as their reported advantages and limitations. Methods A scoping review was conducted to identify studies that described or compared methods for updating PMAs or NMAs within USRs or LSRs. We followed the 2020 Joanna Briggs Institute methodology and searched across major bibliographic databases (MEDLINE, Embase, the Cochrane Library, Cochrane CENTRAL, the Cochrane Methodology Register, ERIC, and PsycINFO) from inception to March 6, 2024. Gray literature and expert recommendations supplemented our literature search. Two reviewers independently screened records, extracted data, and categorized methods. Results Of 2710 records identified, 51 studies and 1 companion report met the inclusion criteria. The studies were grouped into 9 methodological categories: Traditional/Cumulative Meta-analysis, Law of Iterated Logarithm, Shuster Sequential Method, Sequential Meta-Analysis, Trial Sequential Analysis, Stochastic Curtailment, Adaptive Design, Likelihood Ratio Test, and Bayesian meta-analysis. Most studies focused on USRs (72.5%) and PMAs (98%). Trial Sequential Analysis was the most frequently encountered approach (46/51), while only 1 study described an extension to NMA. Methods varied widely in error control and ability to adjust for heterogeneity. While most approaches addressed type I error, fewer considered type II error or heterogeneity. Conclusion This scoping review provides the first comprehensive mapping of methods for updated and living meta-analyses. Despite a range of available approaches, no single method demonstrated superiority across contexts. Further research should compare methods empirically, develop accessible software to support reliable, continuously updated evidence synthesis, and extend frameworks to NMA, especially as only a single methodological study was found for NMA.
Background Health researchers rely on clear, trustworthy methods guidance (MG) to support the planning, conduct, analysis, and interpretation of their studies (eg, guidance on study design, data collection, statistical methods, qualitative analysis). MG should not only be practically useful but also help ensure that the resulting evidence is valid and meaningful to patients, research participants, and other interest-holders. However, how to develop such methods guidance and which processes and approaches are useful is currently unclear. Important uncertainties include how to integrate methodological evidence and the views of health researchers, the intended users. This lack of clarity in the development process may undermine the validity, trustworthiness, and usefulness of MG, ultimately limiting its contribution to the production of high-quality, patient-important evidence. Objectives To describe STrategies for developing REseArch Methods guidance (STREAM). Methods We will work with a steering committee consisting of MG developers, health researchers, and an experienced patient partner who will help us establish a deliberative and meaningful patient contribution. To systematically develop STREAM, we will conduct a series of interlinked studies: (1) Review of existing standards: A scoping review to identify any existing standards or suggestions for developing MG. (2) Study of current practice: We will analyse a sample of recently published MG articles and catalogue the methods used for developing MG. (3) Interviews with MG users: We will conduct interviews with recent users of selected MG articles to elicit their views on strengths, weaknesses, and opportunities for improvement. (4) Development of STREAM: A panel of guidance developers and users from academia and industry will draft an initial version of STREAM and apply consensus methods. The panel will consider the findings from studies 1-3 and processes for developing other types of guidance, such as reporting guidelines and clinical practice guidelines. (5) Testing and refining STREAM: Guidance developers will apply the draft STREAM to ongoing MG development projects and provide feedback that will inform the final version. Results STREAM will be a comprehensive, evidence-informed, user-centred, and practice-tested instrument for creating MG. It will provide practical recommendations for MG developers on involving relevant interest-holders, selecting and using methodological evidence, translating evidence into recommendations, and presenting guidance in a clear and implementable format. Plain Language Summary Health researchers need clear and trustworthy guidance to help them plan, conduct, analyse, and interpret their studies. The guidance should ensure that the research is valid and genuinely beneficial to patients. However, there is currently uncertainty about the ways for creating this guidance. As a result, experts often develop guidance in an unstructured way or are uncertain how to integrate existing evidence or the views of health researchers who are the intended users of the guidance. This may undermine trust in the guidance, making it less helpful than it could be. Our goal is to address this. We aim to provide a process, STREAM, for creating trustworthy and user-friendly guidance that leads to meaningful and valid health research. Here is our plan: (1) Review existing suggestions for creating guidance: We will analyze existing publications that make suggestions on how to create guidance. (2) Review existing guidance: We will analyse a sample of recent guidance to see how experts currently create guidance: for example, how they collected information, involved users, reached a consensus, and tested the guidance. (3) Engage with guidance users: We will interview health researchers who recently used guidance. We want to understand what makes guidance trustworthy and meaningful to them. (4) Develop STREAM: We will assemble a diverse group including experts and health researchers. Together, we will develop the new process, STREAM. (5) Test STREAM: We will collaborate with experts currently creating guidance and ask them to test the new process. We will collect feedback to refine and finalize STREAM. To ensure that our research makes sense, we will consider possibilities for engaging health researchers, patients, and members of the public throughout the projects. In summary, our aim is to provide practical advice for experts who create guidance for conducting health research. We will call the new process STREAM and it will be evidence-based, user-centred, and practice-tested. STREAM will make it easier to create guidance that is clearer for health researchers and will lead to evidence that is more actionable and relevant to patients.
BACKGROUND AND OBJECTIVES:Methodological studies critically evaluate how health research is designed, conducted, analyzed, and reported. Despite their growing importance, currently, there is no reporting tailored to this type of research, which hampers the visibility, reproducibility, and overall utility of the findings of methodological studies. METHODS:We administered a survey to researchers with expertise in designing and performing methodological studies to gather their opinions on appropriate terminology, how they should be categorized, and key reporting elements. Quantitative data were analyzed descriptively, with a content validity ratio applied to determine appropriateness. Qualitative survey responses were analyzed using inductive content analysis. RESULT:Of 499 invited, a total of 119 participants completed the survey (response rate 23%). None of the 13 proposed nomenclatures met the threshold for appropriateness. Of the four proposed study categories, two (study aim and study design) were retained based on expert ratings. Among 23 proposed reporting items, 15 were endorsed for further evaluation. Qualitative responses were condensed and categorized, identifying the importance of flexibility in terminology and concerns about categorization. CONCLUSION:There is substantial disagreement among experts regarding key aspects of methodological studies, particularly related to terminology. While some agreement was observed around study categories and reporting elements, diverse and sometimes conflicting perspectives underscore the complexity of standardizing methodological studies. These findings reinforce the need for a collaborative consensus process to develop reporting guidance that is both practical and adaptable to the nuances of this field.
Background The number of clinical vaccine studies published each year is large and increasing as vaccinology and biotechnology advance. CONSORT and STROBE provide reporting guidelines for randomised clinical trials and observational studies, but neither addresses vaccine-specific items that should be included in vaccine study reports. Thus, there is a need to develop a guideline for reporting studies of a vaccine's characteristics such as immunogenicity, efficacy, effectiveness, reactogenicity, and safety. Methods Using the EQUATOR Network's “Guidance for Developers of Health Research Reporting Guidelines,” we established a core working group to conduct a systematic literature review and develop an initial list of reporting elements for vaccine studies based on CONSORT and STROBE. A 42-member Delphi expert group, composed of clinical vaccine researchers, methodologists, medical journal editors, and other experts, provided comments and suggestions on the initial checklist through two rounds of Delphi surveys. Working group members refined and finalised the checklist after each round, with the approval of advisory group members. Findings Two rounds of Delphi surveys with 42 multidisciplinary global experts generated 87 qualitative comments, producing a final 22-item checklist across 15 domains, including 9 dedicated vaccine-specific reporting items. All items were refined with detailed explanations and representative clinical study examples. Interpretation VAccine cLinical trial reporting gUidEline (VALUE) aims to provide a minimum set of vaccine-specific reporting items for experimental and observational clinical studies that evaluate characteristics of vaccines. Developed with methods recommended by the EQUATOR collaborative network, VALUE complements CONSORT and STROBE statements by addressing vaccine-specific needs, aiming to serve as a valuable resource for vaccine researchers and improve reporting of clinical vaccine studies. Funding This work was funded by the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences, the National Key Research and Development Program of China, and the Vincent and Lily Woo Foundation.
OBJECTIVES:The application of large language models (LLMs) to systematic review tasks is rapidly expanding, yet the transparency and methodological rigor of these evaluations remain unclear. We aimed to assess reporting transparency, methodological quality, and how authors frame claims and caveats in studies applying LLMs to systematic review tasks. STUDY DESIGN AND SETTING:We conducted a cross-sectional meta-epidemiological study by searching PubMed, Embase, Web of Science Core Collection, IEEE Xplore, and five other databases from inception to December 1, 2025, for peer-reviewed articles and preprints. We included empirical studies evaluating generative transformer-based LLMs (eg, Gemini) for core systematic review tasks (eg, screening, data extraction) against a reference standard. We assessed reporting transparency using an adapted Chatbot Assessment Reporting Tool and methodological quality using an adapted Quality Assessment of Diagnostic Accuracy Studies 2 tool. We also analyzed the frequency and strength of claims and caveats mentioned by the authors. The study is registered with the Open Science Framework (https://osf.io/8edhb). RESULTS:We identified and included 229 studies comprising 440 empirical tasks. Reporting transparency was moderate, with a mean item score of 0.52 (standard deviation 0.30) on a 0-1 scale, where higher values indicate more complete reporting. We observed substantial gaps in reproducibility-essential domains, including protocol information (mean score 0.12) and model details (0.30). Although 60.6% of assessments were rated as having a low risk, key safeguards against overfitting and data leakage were rarely reported; for example, locking the test set before prompt optimization, a basic protection against information leakage, was not reported in 99.8% of tasks. We identified 837 claims and 693 caveats. Authors framed claims weakly more often than strongly (66.8% vs 33.2%). Performance superiority over a comparator was the most common claim (64.8% of tasks). Readiness for practical use was claimed in 47.5% of tasks, almost always in qualified terms (93.3%). CONCLUSION:Studies applying LLMs to systematic review tasks are reported with moderate transparency but often omit reproducibility-critical details necessary to assess leakage and overfitting. Although authors frequently make claims about performance and practice readiness, these are typically expressed cautiously. Improved reporting standards and clearer safeguards are urgently needed before routine use of LLMs in evidence synthesis can be recommended. PLAIN LANGUAGE SUMMARY:LLMs, such as ChatGPT, are increasingly used to help carry out parts of systematic reviews, which summarize evidence to inform healthcare decisions. We examined 229 studies that tested LLMs on tasks such as screening articles, extracting data, and assessing study quality, covering 440 evaluations in total. On average, these studies reported their methods with moderate clarity, but often omitted information needed to repeat the work or judge whether the results were trustworthy. Notably, almost none described safeguards to ensure that the test data had not already influenced how the model was set up, a key step for avoiding overly optimistic results. Authors frequently described LLMs as performing well and nearly ready for practical use, though usually in cautious terms. Clearer reporting standards and stronger safeguards are needed before LLMs can be routinely relied upon in evidence synthesis.
BACKGROUND AND OBJECTIVE:The need to design randomized controlled trials (RCTs) with explicit intent, either pragmatic or explanatory, and matching design features is well recognized. There is a need for clear, standardized reporting recommendations for protocols for these RCTs to facilitate communication of trialists' intention and trial design choices. This protocol outlines the development process of a Standard Protocol Items: Recommendations for Interventional Trials extension applicable to RCTs where authors explicitly declare their intention for the trial. This will enhance the transparency, reproducibility, and comprehensiveness of RCT protocol reports. METHODS:Using the Enhancing the QUAlity and Transparency of health Research Network's structured multiphase approach, the study begins with a scoping review to identify existing literature and reporting guidelines for pragmatic and explanatory RCTs designed using the PRECIS tool (PRECIS RCTs), which will inform a draft checklist. An international panel including trialists, trial methodologists, clinicians and policy decision-makers, biostatisticians, regulatory representatives, research funders, journal editors, and patient partners will then participate in a Delphi process to achieve consensus on essential checklist items. This will involve at least two rounds of structured surveys. A consensus meeting with approximately 30 experts will meet to finalize the checklist items, incorporating findings from both the scoping review and the Delphi process. The authors will draft the final SPIRIT-PRECIS checklist and accompanying explanation documents. The checklist will be pilot tested with end users to ensure their clarity and practical utility. The final checklist will be refined based on feedback from pilot testing and disseminated through publications, workshops, and online training opportunities. RESULTS:The study will produce a consensus-based SPIRIT-PRECIS checklist and accompanying explanation documents for reporting protocols of RCTs in which authors explicitly declare their trial intention. CONCLUSION:The SPIRIT-PRECIS checklist is expected to enhance the transparency, reproducibility, and comprehensiveness of RCT protocol reports by providing standardized reporting recommendations for protocols of pragmatic and explanatory RCTs.
Interest in performing individual participant (or patient) data meta-analysis (IPD-MA) from randomized controlled trials (RCTs) has increased in recent years. With our PubMed search approach which considered only the titles of the articles and was conducted in October 2025, the first IPD-MA was published in 1998, whereas 198 were published in the first 9 months of 2025. Researchers use PRISMA 2020 and, above all, PRISMA-IPD to report the results of these studies. There are five ethics items─which are not included in either PRISMA 2020 or PRISMA-IPD─that are inconsistently included in the IPD-MA published in prominent medical journals, as shown in a sample of 19 IPD-MAs published in top general/internal medicine journals between January and September 2025. Two items refer to the RCTs included in the meta-analysis, i.e., whether approval from a research ethics committee (REC) was obtained, and whether participants of those trials provided informed consent. The other three items refer to the IPD-MA itself, i.e., whether it was approved by an REC, what the de-identification status was for the data (i.e. pseudonymized vs. anonymized), and whether the participants in all the trials included in the meta-analysis had given their consent or had not objected to the secondary use and sharing of their data with third parties. Due to their relevance, readers should be informed about these five items in the text of the IPD-MA or, as an alternative in certain cases, in the disclosure section of the IPD-MA published report. Specifically, the two items of information concerning the trials included in the IPD-MA should be included in an updated PRISMA 2020. All five items should be included in the next update of the PRISMA-IPD.
INTRODUCTION:Health researchers benefit from methods guidance (MG) for planning, conducting, analyzing and interpreting research studies. How to develop MG that is trustworthy and researcher-friendly is unclear; existing strategies for developing MG are fragmented and lack a coherent framework. The STrategies for developing REseArch Methods guidance (STREAM) project aims to provide such a framework for developers of MG. As a first step, we reviewed the literature to identify proposed and applied strategies for developing MG and explored possible knowledge gaps. METHODS:We conducted two literature reviews. First, a scoping review of the methodological literature to identify proposed strategies for developing MG. Second, a review of a purposeful sample of recently published MG articles to examine strategies applied in practice. We applied a qualitative content analysis to both sets of publications using one shared codebook. In addition, to identify possible knowledge gaps, we contrasted the findings with the established development processes for clinical practice guidelines and reporting guidelines. RESULTS:The first review included 17 publications and the second review 102 MG articles. We identified possible development steps including assessing the need for MG, establishing a working group, considering the findings from methodological studies, gathering input from interest-holders, testing the new MG, and disseminating and implementing MG. In addition, we identified various approaches to perform the steps including systematic reviews of previous guidance, reviews of methodological practice, simulation studies, surveys or interviews of interest-holders, consensus methods, and public review. Mapping these findings with established development processes identified areas that have so far received limited attention within MG development, including considering evidence from methodological research, judging the certainty of this evidence, reporting of MG, and approaches to implementation. CONCLUSION:This study provides an overview of proposed and applied strategies for developing MG, highlights needs for conceptual development, and provides a structured starting point for guidance for developing MG. PLAIN LANGUAGE SUMMARY:Almost every method used in health research comes with its own guidance - sets of advice and suggestions on how to plan and carry out the research, as well as helping with the analysis and interpretation of the results. When this guidance is clear and can be trusted, it helps researchers produce evidence that is valid and useful. However, the process for developing such guidance is currently unclear. The aim of this project called STrategies for developing REseArch Methods guidance (STREAM)is to create a framework for developing trustworthy, and user-friendly methods guidance. In this manuscript, we report on two literature reviews that will inform the new strategies. In the first, we looked for existing publications that suggest strategies for developing methods guidance. Secondly, we examined recently published methods guidance articles to see how they were developed. We also compared our findings with established development processes for other kinds of guidance: clinical practice guidelines and reporting guidelines. As a result, we found many possible and complementary strategies for developing methods guidance: forming a working group, reviewing previous research; seeking input from interest-holders; testing the guidance; and actively supporting dissemination and use. We also identified important areas where further research is needed. For example, we found that it is currently unclear how previous research should inform methods guidance or how to optimally present it. In summary, our reviews identified various possible strategies for developing methods guidance but also important gaps that the framework for developing methods guidance should address.
OBJECTIVES:This study aimed to explore systematic review protocol authors' adherence to and experiences with the Preferred Reporting Items for Systematic reviews and Meta-Analyses Protocols (PRISMA-P) 2015 reporting guideline. METHODS:We randomly sampled 100 non-overlapping systematic review protocols from May 2021 to May 2024: 50 from PubMed-indexed journals and 50 from Open Science Framework (OSF)/the International Prospective Register of Systematic Reviews (PROSPERO). Two authors independently assessed adherence to the 26 PRISMA-P 2015 items as fully, partially (ie, when some, but not all, aspects of an item were reported according to predefined criteria), or not reported (or not applicable). We analysed adherence within the 2 protocol types separately. Forty-three systematic review protocol authors were invited for interviews on their experiences with using PRISMA-P 2015. We used a semistructured interview guide, involving 3 prespecified themes: level of experience, views on using PRISMA-P 2015, and reflections on the guideline's strengths and challenges. We applied framework analysis to the interview transcripts. RESULTS:Among the 50 PubMed protocols, the median proportion of fully reported applicable PRISMA-P items was 60% (IQR 52%-64%). The median proportion for OSF/PROSPERO protocols was 45% (IQR 38%-58%). Across both types of protocols, >25% were found not to report 6 items: protocol amendments, role of funder, criteria for quantitative synthesis, methods for planned summary other than quantitative meta-bias(es), and confidence in the cumulative evidence. In both types of protocols, >25% were found to partially report 11 items. Fifteen authors participated in the interviews. Through the interviews, suggestions for updating PRISMA-P 2015 emerged. Most suggestions concerned either adding or modifying existing content, for example, to report conflicts of interest, or clarify guidance on how to report data synthesis when no meta-analysis is planned; other suggestions were more general, for example, to add links to the Elaboration and Explanation paper. CONCLUSION:Adherence to some PRISMA-P 2015 items was low among 50 PubMed systematic review protocols and even lower among 50 OSF/PROSPERO protocols. Six items were often not reported across both types of protocols. The interviewed authors suggested various additions and modifications to the guideline. Findings from this study provide context for users of the reporting guideline and will inform a forthcoming update of PRISMA-P 2015. PLAIN LANGUAGE SUMMARY:Researchers collect and summarise findings from several studies to better understand a specific health issue. These summaries are called systematic reviews. Health care guidelines are often based on results from systematic reviews. This makes systematic reviews very important for health care professionals and patients. To make sure that these results can be trusted and used, systematic reviews need to be done in a clear way. It needs to be so clear that other researchers can understand and repeat it. One way to do this is to write in detail how the review is planned before starting it. This is called a protocol. It can be useful with a guide to help authors write protocols with enough details. Such a guideline for writing protocols exists and is called PRISMA-P. It includes a checklist of 26 different items that should be described in a protocol. However, research shows that authors may not follow such guidelines closely. So far, no research has looked at how protocol authors use PRISMA-P or what makes it easier or harder to follow. In our study, we wanted to explore how protocol authors use PRISMA-P and what they think about it. We checked 100 protocols to see how well all 26 PRISMA-P items were described. We also interviewed 15 protocol authors about how they use PRISMA-P and if they had suggestions for improving it. We found that in more than 25% of the protocols, 6 specific items were not described. We also found that in more than 25% of the protocols, 11 other items were only partially described. The interviewed authors suggested many ways to improve PRISMA-P. For example, they suggested making instructions clearer on how to follow the individual items. They also suggested adding new content to PRISMA-P. Our findings will make it easier to read, write, and evaluate protocols for systematic reviews. The findings can also be used for a future update of PRISMA-P.
Transparency and openness are core scientific values that enable independent verification of reported research results. The Transparency and Openness Promotion (TOP) Guidelines, first published in 2015 (TOP 2015), provided a flexible framework for journals to design and implement publication standards promoting these values. Over the past decade, widespread use of TOP 2015 contributed to valuable evidence and feedback for refinement. The TOP Advisory Board undertook a comprehensive update of TOP 2015 that went into effect in 2025 (TOP 2025). The update introduces an explicit conceptual framework clarifying its primary objective: improving the verifiability of empirical research claims. Standards are reorganized into three categories (Research Practices, Verification Practices, and Verification Studies) that resolve conceptual and structural limitations of TOP 2015. Research Practices include seven discrete practices implemented in three ways: Disclosed, Shared and Cited, and Certified. Verification Practices introduce standards for computational reproducibility and results transparency, while Verification Studies enumerate empirical research designs and publication formats that support verification of results. Language now centers on researchers and studies (rather than journals) to facilitate adoption by funders, research organizations, preprint servers, evidence curators, and other interest-holders. These changes promote flexible implementation and contextual tailoring. TOP 2025 retains the core strengths of TOP 2015 while addressing feedback from a decade of implementation and advances in open science. Rather than a universal mandate, it provides a shared, adaptable framework to coordinate the design, implementation, and communication of open policies across interest-holders.
Objectives To determine how patients use the internet to get health information and to identify their needs and preferences for a journal transparency tool which would highlight journal transparency practices.Design A mixed-methods study comprising a cross-sectional online survey followed by virtual focus groups to further explore the survey responses.Setting Canada.Participants A total of 183 adult patients and caregivers completed our online survey. 29 survey respondents participated in the subsequent focus groups.Primary and secondary outcome measures We report descriptive statistics (counts and percentages) for all quantitative survey items. We used thematic content analysis for text-based survey responses. The focus groups asked patients about four key topics: (1) the content they would like to see in a journal transparency tool, (2) how they would like the content visually displayed, (3) how to best share the tool with patients and (4) how to determine whether the tool was successful over time. We conducted a thematic content analysis to identify core themes discussed. Focus group participants then rank-ordered the themes identified by their perceived importance.Results Of the 183 survey respondents, 146 (82%) indicated they use the internet most often when looking for health information, 66 (37%) indicated they sometimes read original research articles when searching for health information and 92 (52%) indicated they sometimes have difficulty knowing if the information they read online is reliable. Approximately half (86; 49%) of the survey respondents had never heard of predatory journals. We identified 32 themes across the four key topic areas that were discussed in the focus groups.Conclusions Patients have expressed a need for a journal transparency tool. This study will inform the tool’s development to ensure that it meets the needs and preferences of patients.
Open science remains vital to the progress and functioning of the global research enterprise. Published in 2015, the Transparency and Openness Promotion Guidelines (TOP 2015) was developed as a policy framework to enhance the verifiability of empirical research claims in journal articles. It has been widely used and adopted by publishers and academic journals, but despite its uptake, concerns have been raised about aspects of the TOP 2015 framework and its implementation. In response to the above, the purpose of this manuscript is to introduce an official update to the TOP Guidelines. The final version—TOP 2025—provides updated guidelines for promoting the verifiability of published empirical research claims.
Incomplete and inaccurate reporting of research can prevent research from being used. Reporting guidelines aim to circumvent this by providing recommendations that support researchers in writing complete and accurate accounts of their work. While reporting guidelines have many benefits, challenges exist for both developers and users. In this article, we outline initiatives implemented to address challenges within the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) family of guidelines and highlight opportunities for future work.
Background Narrative CVs (NCVs) are increasingly being adopted as part of responsible research assessment initiatives that seek to recognize diverse scholarly contributions beyond traditional quantitative metrics. As funding agencies, institutions, and research organizations implement NCVs, effective training is needed to support both applicants and reviewers. This scoping review aimed to characterize publicly available training and guidance resources for NCVs. Methods We conducted a scoping review following the Arksey and O’Malley framework and reported findings according to the PRISMA-ScR guidelines. Searches of MEDLINE, Embase, PsycINFO, ERIC, Web of Science, preprint servers, and extensive grey literature were conducted from 2010 to October 2025. English and French resources providing guidance on writing and/or evaluating NCVs were eligible. Data was extracted in duplicate and summarized using descriptive statistics. Results 65 training resources met the inclusion criteria. Most originated from Canada (38.46%) and the United Kingdom (24.62%) and were produced by universities (43.08%), funders (38.46%), or government organizations (26.15%). Common formats included resource websites (27.69%), webinars (23.08%), and commentary articles (13.85%). Most resources targeted applicants (83.08%), while only 23.08% targeted reviewers. Frequently covered topics were structuring NCV sections, explaining the purpose of NCVs, and presenting non-traditional research contributions. However, reviewer guidance (13.85%) and addressing bias in narrative assessment (15.38%) were infrequently covered. Although most resources were freely accessible (92.31%), only a few had accessibility features (9.24%). Practical tools to support NCV writing and assessment were also inconsistently provided and only 21.54% reported any evaluation of effectiveness. Conclusion Current NCV training resources reflect growing international adoption of responsible research assessment. However, they largely focus on applicants, and gaps remain in reviewer-focused guidance, accessibility, practical tools, and the evaluation of training effectiveness. Developing evidence-informed and rigorously evaluated training resources will support more equitable and effective implementation of narrative CVs.
La participación de pacientes y ciudadanos en la investigación contribuye a mejorar la relevancia de los estudios, aunque su presentación en la literatura es inconsistente y poco clara. Para mejorar la transparencia y la calidad de esta participación se desarrollaron las guías GRIPP2 (Guidance for Reporting Involvement of Patients and the Public), que ofrecen orientación específica para una presentación sistemática y transparente. Esta nota metodológica describe la adaptación y traducción al español de dichas guías, con el objetivo de fomentar la calidad, la coherencia y la transparencia en la evidencia sobre la participación de pacientes y ciudadanos en la investigación. Se presentan dos versiones: GRIPP2 formulario largo, con 34 ítems orientados a estudios en los que la participación de pacientes y ciudadanos es el foco principal, y GRIPP2 formulario corto, con 5 ítems para estudios en los que esta participación es un componente secundario. Las guías están dirigidas fundamentalmente a investigadores y autores que quieran incorporar la participación de pacientes y ciudadanos en sus investigaciones, así como a revisores y editores de revistas. Además, también pueden ser de interés para responsables de políticas de investigación, agencias financiadoras, agencias de evaluación de tecnologías sanitarias y, por supuesto, pacientes y ciudadanos.
BACKGROUND AND OBJECTIVES:Numerous studies have assessed the adherence of published systematic reviews to the PRISMA 2020 statement. We aimed to summarize the characteristics and methods of development of the tools used to assess adherence in these studies. METHODS:MEDLINE, Embase, and PsycINFO (all via Ovid) were searched on January 20, 2025, to locate studies that assessed adherence of systematic reviews of health interventions to the PRISMA 2020 statement. Two authors independently screened all records and extracted data. We examined three aspects of the tools used to assess adherence to PRISMA 2020: i) characteristics of the assessment tool, ii) methods used to develop and validate the tool, and iii) processes used to apply the tool. We classified a tool as "implementable" by researchers external to the tool developers if authors reported the exact wording of each item, its response options, guidance on how to operationalize all response options, and the algorithms used to aggregate judgments and quantify adherence. RESULTS:We included 24 meta-research studies that had assessed adherence to PRISMA 2020 in 2766 systematic reviews published between 1989 and 2024. Most authors assessed adherence to PRISMA 2020 in its entirety (N = 15/24, 63%), with the remaining nine (37%) assessing adherence to one or a subset of domains (eg, abstract, search methods, and risk of bias assessment methods). Psychometric testing of the assessment tool was reported by five studies (21%), all of which assessed the inter-rater reliability of the tool. Only one (4%) reported how response options for all items were operationalized. According to our criteria, only one assessment tool was classified as implementable (N = 1/24, 4%). No authorship team used the same methods to assess adherence to the PRISMA 2020 statement. However, information on some tool characteristics was unavailable for several studies. CONCLUSION:Our findings demonstrate variation and inadequacies in the methods and reporting of tools used to assess adherence to the PRISMA 2020 statement. We have commenced work on a standardized PRISMA 2020 assessment tool to facilitate accurate and consistent assessments of adherence of systematic reviews to PRISMA. In the interim, we provide some recommendations for how meta-researchers interested in assessing adherence of systematic reviews to the PRISMA 2020 statement can transparently report the findings of their assessments.