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The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally affected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets.

AbstractThe SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes.The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The SPIRIT-AI extension includes 15 new items, which were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations around the handling of input and output data, the human-AI interaction and analysis of error cases.SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.

Global biomedical and public health research involves billions of dollars and millions of people. Although this vast enterprise has led to substantial health improvements, many more gains are possible if the waste and inefficiency in the ways that biomedical research is chosen, designed, done, analysed, regulated, managed, disseminated, and reported can be addressed.

Systematic reviews of clinical trials aim to include all relevant studies conducted on a particular topic and to provide an unbiased summary of their results, producing the best evidence about the benefits and harms of medical treatments. Relevant studies, however, may not provide the results for all measured outcomes or may selectively report only some of the analyses undertaken, leading to unnecessary waste in the production and reporting of research, and potentially biasing the conclusions to systematic reviews. In this article, Kirkham and colleagues provide a methodological approach, with an example of how to identify missing outcome data and how to assess and adjust for outcome reporting bias in systematic reviews.

Randomised controlled trials commonly use surrogate endpoints to substitute for a target outcome (outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve their efficiency (through shorter trial duration, reduced sample size, and thus lower research costs), or for ethical or practical reasons. But reliance on surrogate endpoints can increase the uncertainty of an intervention’s treatment effect and potential failure to provide adequate information on intervention harms, which has led to calls for improved reporting of trials using surrogate endpoints. This report presents a consensus driven reporting guideline for trials using surrogate endpoints as the primary outcomes—the CONSORT (Consolidated Standards of Reporting Trials) extension checklist: CONSORT-Surrogate. The extension includes nine items modified from the CONSORT 2010 checklist and two new items. Examples and explanations for each item are provided. We recommend that all stakeholders (including trial investigators and sponsors, journal editors and peer reviewers, research ethics reviewers, and funders) use this extension in reporting trial reports using surrogate endpoints. Use of this checklist will improve transparency, interpretation, and usefulness of trial findings, and ultimately reduce research waste.

Objectives To examine the reporting characteristics and methodological details of randomised trials indexed in PubMed in 2000 and 2006 and assess whether the quality of reporting has improved after publication of the Consolidated Standards of Reporting Trials (CONSORT) Statement in 2001.Design Comparison of two cross sectional investigations.Study sample All primary reports of randomised trials indexed in PubMed in December 2000 (n=519) and December 2006 (n=616), including parallel group, crossover, cluster, factorial, and split body study designs.Main outcome measures The proportion of general and methodological items reported, stratified by year and study design. Risk ratios with 95% confidence intervals were calculated to represent changes in reporting between 2000 and 2006.Results The majority of trials were two arm (379/519 (73%) in 2000 v 468/616 (76%) in 2006) parallel group studies (383/519 (74%) v 477/616 (78%)) published in specialty journals (482/519 (93%) v 555/616 (90%)). In both 2000 and 2006, a median of 80 participants were recruited per trial for parallel group trials. The proportion of articles that reported drug trials decreased between 2000 and 2006 (from 393/519 (76%) to 356/616 (58%)), whereas the proportion of surgery trials increased (51/519 (10%) v 128/616 (21%)). There was an increase between 2000 and 2006 in the proportion of trial reports that included details of the primary outcome (risk ratio (RR) 1.18, 95% CI 1.04 to 1.33), sample size calculation (RR 1.66, 95% CI 1.40 to 1.95), and the methods of random sequence generation (RR 1.62, 95% CI 1.32 to 1.97) and allocation concealment (RR 1.40, 95% CI 1.11 to 1.76). There was no difference in the proportion of trials that provided specific details on who was blinded (RR 0.91, 95% CI 0.75 to 1.10). Conclusions Reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level. Without complete and transparent reporting of how a trial was designed and conducted, it is difficult for readers to assess its conduct and validity.

Abbreviations: FDA, Food and Drug Administration; NDA, new drug application Provenance: Commissioned; not externally peer reviewed Although randomized trials provide key guidance for how we practice medicine, trust in their published results has been eroded in recent years due to several high-profile cases of alleged data suppression, misrepresentation, and manipulation [1-5, 39]. [...]only devices, pharmaceuticals, and biological agents require regulatory approval in the United States and other countries, meaning that trials examining other types of interventions (e.g., surgery, education)--which constitute 20% of published randomized trials [24]--would be excluded from reviews of regulatory agency documents.

To update SPIRIT 2013 and CONSORT 2010 reporting guidelines. For SPIRIT 2025, a comprehensive review process incorporating scoping reviews, expert consultations, and a Delphi survey led to a revised checklist. CONSORT 2025 underwent a similar update, addressing methodological advancements and user feedback gathered through scoping reviews, expert consultations, and a Delphi survey. Key changes include the addition of two new items, revisions to five, and the deletion or merging of five, alongside a new Open Science section. Emphasis on harm assessment, intervention description, and patient/public involvement has also been strengthened. The SPIRIT 2025 statement provides a 34-item checklist, a schedule diagram, and an expanded checklist with explanations. Similarly, seven new items were added, three revised, and one deleted, with content integrated from existing CONSORT extensions. A new Open Science section was also incorporated. The CONSORT 2025 statement offers a 30-item checklist, a flow diagram, and a detailed explanatory checklist. Both updated statements and explanatory articles aim to enhance transparency and completeness in trial protocols and reporting. Widespread adoption by investigators, funders, ethics committees, journals, and regulators should improve the quality and usability of research, ultimately benefiting patients and others. We have updated two important guidelines, SPIRIT and CONSORT, to make research studies easier to understand and more reliable. We did this by carefully reviewing existing research and getting feedback from experts around the world. The new SPIRIT 2025 guideline has 34 items to help researchers report their study plans clearly. It includes new sections on how to assess potential risks, describe the treatment, and involve patients in the research. We also added a new section about sharing data openly. The new CONSORT 2025 guideline has 30 items to help researchers report the results of their studies. It includes new sections on harms, outcomes, nondrug treatments, and how treatments are tailored to individuals. Like SPIRIT 2025, it also has a new section on open science. We have also created detailed guides to help people use these new guidelines. We hope that by using these updated guidelines, researchers, funders, ethics committees, journals, and regulators will help improve the quality of research and ultimately benefit patients. •Accurate interpretation of randomized trials requires complete and transparent reporting of methods and findings.•The SPIRIT 2025 statement updates guidance on trial protocol content, incorporating methodological advances and user feedback.•SPIRIT 2025 includes three key components for trial protocol guidance: a 34-item checklist, a schedule diagram, and an expanded checklist with detailed explanations.•For reporting randomized trials, the CONSORT 2025 Statement includes a 30-item checklist, a flow diagram, and a detailed explanation of each checklist item.

Lack of ethnic diversity in trials may contribute to health disparities and to inequity in health outcomes. The primary objective was to investigate the experiences and perspectives of ethnically diverse populations about how to improve ethnic diversity in trials. Qualitative data were collected via 16 focus groups with participants from 21 ethnically diverse communities in Australia. Data collection took place between August and September 2022 in community-based settings in six capital cities: Sydney, Melbourne, Perth, Adelaide, Brisbane, and Darwin, and one rural town: Bordertown (South Australia). One hundred and fifty-eight purposively sampled adults (aged 18–85, 49% women) participated in groups speaking Tamil, Greek, Punjabi, Italian, Mandarin, Cantonese, Karin, Vietnamese, Nepalese, and Arabic; or English-language groups (comprising Fijian, Filipino, African, and two multicultural groups). Only 10 participants had previously taken part in medical research including three in trials. There was support for medical research, including trials; however, most participants had never been invited to participate. To increase ethnic diversity in trial populations, participants recommended recruitment via partnering with communities, translating trial materials and making them culturally accessible using audiovisual ways, promoting retention by minimizing participant burden, establishing trust and rapport between participants and researchers, and sharing individual results. Participants were reluctant to join studies on taboo topics in their communities (eg, sexual health) or in which physical specimens (eg, blood) were needed. Participants said these barriers could be mitigated by communicating about the topic in more culturally cognizant and safe ways, explaining how data would be securely stored, and reinforcing the benefit of medical research to humanity. Participants recognized the principal benefits of trials and other medical research, were prepared to take part, and offered suggestions on recruitment, consent, data collection mechanisms, and retention to enable this to occur. Researchers should consider these community insights when designing and conducting trials; and government, regulators, funders, and publishers should allow for greater innovation and flexibility in their processes to enable ethnic diversity in trials to improve. [Display omitted]

Evidence in the medical literature suggests that trial registration may not be preventing selective reporting of results. We wondered about the place of such information in the peer-review process. We asked 1,503 corresponding authors of clinical trials and 1,733 reviewers to complete an online survey soliciting their views on the use of trial registry information during the peer-review process. 1,136 authors (n = 713) and reviewers (n = 423) responded (37.5%); 676 (59.5%) had reviewed an article reporting a clinical trial in the past 2 years. Among these, 232 (34.3%) examined information registered on a trial registry. If one or more items (primary outcome, eligibility criteria, etc.) differed between the registry record and the manuscript, 206 (88.8%) mentioned the discrepancy in their review comments, 46 (19.8%) advised editors not to accept the manuscript, and 8 did nothing. The reviewers' reasons for not using the trial registry information included a lack of registration number in the manuscript (n = 132; 34.2%), lack of time (n = 128; 33.2%), lack of usefulness of registered information for peer review (n = 100; 25.9%), lack of awareness about registries (n = 54; 14%), and excessive complexity of the process (n = 39; 10.1%). This survey revealed that only one-third of the peer reviewers surveyed examined registered trial information and reported any discrepancies to journal editors.