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Background: Chronic diseases are the leading cause of mortality and morbidity worldwide. Much of this burden can be prevented by adopting healthy behaviours and reducing chronic disease risk factors. Settings-based approaches to address chronic disease risk factors are recommended globally. Sporting organisations are highly prevalent, and engage many people in many countries. As such, they represent an ideal setting for public health interventions to promote health. However, there is currently limited evidence of their impact on healthy behaviour and health outcomes as previous systematic reviews are either limited in their scope (e.g. restricted to professional sporting organisations), or are out of date., Objectives: Primary: to assess the benefits and harms of interventions implemented through sporting organisations to promote healthy behaviours (including physical activity, healthy diet) or reduce health risk behaviours (including alcohol consumption, tobacco use). Secondary: to assess the benefits and harms of these interventions to promote health outcomes (e.g. weight), other health-related behaviours (e.g. help-seeking behaviour) or health-related knowledge; to determine whether benefits and harms differ based on the characteristics of the interventions, including target population and intervention duration; to assess unintended adverse consequences of sporting organisation interventions; and to describe their cost or cost-effectiveness., Search Methods: We searched CENTRAL, MEDLINE, Embase, one other database and two clinical trial registries, from inception to May 2024, to identify eligible trials. We searched Google Scholar in May 2024. We did not impose language or publication status restrictions. We also searched reference lists of included trials for other potentially eligible trials., Selection Criteria: We included randomised controlled trials (RCTs), including cluster-RCTs, of any intervention conducted within or using a sporting organisation for access to a target group, that aimed to improve a health behaviour primary outcome or a secondary review outcome, and had a parallel control group (no intervention, alternative intervention). Eligible participants were any individual exposed to an intervention involving a sporting organisation, including players, members, coaches, and supporters., Data Collection and Analysis: We used standard methodological procedures expected by Cochrane. We conducted random-effects meta-analyses to synthesise results where we could pool data from at least two trials. Where we could not conduct meta-analysis, we followed Cochrane guidance for synthesis using other methods and reported results according to the Synthesis Without Meta-analysis (SWiM) guidance., Main Results: We included 20 trials (42 trial arms, 8179 participants) conducted in high-income countries, and identified four ongoing trials and four trials awaiting classification. There was considerable heterogeneity in the type of participants, interventions and outcomes assessed across trials. Included trials primarily targeted sporting organisation members (eight trials) or supporters (eight trials), males only (11 trials) and adults (14 trials). Football clubs (e.g. soccer, American football, Australian football league) were the most common intervention setting (15 trials), and interventions targeted various combinations of health behaviours, knowledge and health outcomes. Fourteen trials (10 RCTs and four cluster-RCTs) assessed the impact of a sporting organisation intervention on a primary outcome: physical activity (nine trials); diet (six trials); alcohol consumption (11 trials); and tobacco use (two trials). For RCTs, we assessed the risk of bias for primary outcomes (physical activity, diet, alcohol consumption) and unintended adverse consequences as being at low risk of bias (four outcomes), some concerns (one outcome) or high risk of bias (32 outcomes), due to outcomes being self-reported. For cluster-RCTs, we assessed the risk of bias for all primary outcomes (alcohol consumption, tobacco use) as high risk (eight outcomes), due to outcomes being self-reported. Sporting organisation interventions versus control probably have a small positive effect on the amount of physical activity per day, equivalent to approximately 7.4 minutes of moderate-to-vigorous physical activity (MVPA) per day (standardised mean difference (SMD) 0.36, 95% confidence interval (CI) 0.22 to 0.49; I 2 = 3%; 4 trials, 1213 participants; moderate-certainty evidence) and may not reduce sedentary behaviour (mean difference (MD) -15.18, 95% CI -30.82 to 0.47; I 2 = 0%; 2 trials, 1047 participants; low-certainty evidence). Sporting organisation interventions versus control may have a moderate positive effect on fruit and vegetable consumption, equivalent to a score increase of 1.25 points on a 12-point scale for frequency of fruit and vegetable consumption (SMD 0.50, 95% CI 0.35 to 0.65; I 2 = 0%; 5 trials, 1402 participants; low-certainty evidence). Sporting organisation interventions versus control may reduce sugary drink consumption (equivalent to a reduction of sugary drink consumption by 0.8 times per day), but the evidence is very uncertain (SMD -0.37, 95% CI -0.64 to -0.10; I 2 = 0%; 2 trials, 225 participants; very low-certainty evidence). Sporting organisation interventions versus control may have little to no effect on alcohol consumption (equivalent to a reduction of 0.38 units of alcohol consumed per week), but the evidence is very uncertain (MD -0.38, 95% CI -1.00 to 0.24; I 2 = 78%; 7 trials, 2313 participants; very low-certainty evidence). Two trials that could not be synthesised reported equivocal findings on tobacco use (low-certainty evidence). The evidence is very uncertain about the effect of sporting club interventions on unintended adverse consequences. Five trials assessed this outcome, with two reporting that there were no adverse consequences, one reporting only non-serious adverse consequences, and two reporting that there were serious unintended adverse consequences in less than 1% of participants., Authors' Conclusions: Overall, sporting organisation interventions probably increase MVPA by 7.4 minutes per day, may result in little to no difference in sedentary behaviour, and may increase fruit and vegetable consumption. The evidence is very uncertain about whether sporting organisation interventions decrease sugary drink and alcohol consumption. Findings for tobacco use and unintended adverse consequences were equivocal in the few trials reporting these; thus, the evidence was very uncertain. These findings should be interpreted in the context of the heterogeneity of the interventions, participants and sporting organisations for some outcomes., (Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Competing Interests: Competing interests: PH and JJM are co-founders of the systematic review software PITTS. AN is a co-founder of Evidence Prime, the company behind the development of the systematic review software LASER AI. JT is involved in the development of the systematic review software EPPI-Reviewer. These relationships may be considered a potential conflict of interest. All authors have made every effort to ensure that the article is objective and based on sound scientific evidence, without any influence from commercial interests.

Objectives: This study aimed to develop and apply a structured approach for prioritising topics for systematic reviews in public health, framed according to the readily applicable PICO format, which encourages the involvement of stakeholders' preferences in a transparent matter., Methods: We developed a multi-stage process, consisting of a scoping and two Delphi stages with web-based surveys and invited public health stakeholders in Switzerland to participate: First, respondents specified topics for different public health domains, which were reformulated in a PICO format by content analysis. Second, respondents rated the topics using five stakeholder-refined assessment criteria. Overall rankings were calculated to assess differences between stakeholder groups and rating criteria., Results: In total, 215 respondents suggested 728 topics altogether. The response rate in the two Delphi stages was 91.6% and 77.6%, respectively. Most top-rated review topics focused on the effectiveness of interventions providing education to different target groups, followed by interventions to increase access to specific healthcare services., Conclusion: Our approach encourages involvement of stakeholders in identifying priorities for systematic reviews and highlights disparities between stakeholders and between individual criteria., Competing Interests: The authors declare that they do not have any conflicts of interest., (Copyright © 2024 Hoekstra, Mütsch, Borchard, Kien, Griebler, Von Elm, Rehfuess, Gerhardus and Lhachimi.)

Background: Diabetic peripheral neuropathy (DPN) is a frequent complication in people living with type 1 or type 2 diabetes. There is currently no effective treatment for DPN. Although alpha-lipoic acid (ALA, also known as thioctic acid) is widely used, there is no consensus about its benefits and harms., Objectives: To assess the effects of alpha-lipoic acid as a disease-modifying agent in people with diabetic peripheral neuropathy., Search Methods: On 11 September 2022, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, and two clinical trials registers. We also searched the reference lists of the included studies and relevant review articles for additional references not identified by the electronic searches., Selection Criteria: We included randomised clinical trials (RCTs) that compared ALA with placebo in adults (aged 18 years or older) and that applied the study interventions for at least six months. There were no language restrictions., Data Collection and Analysis: We used standard methods expected by Cochrane. The primary outcome was change in neuropathy symptoms expressed as changes in the Total Symptom Score (TSS) at six months after randomisation. Secondary outcomes were change in neuropathy symptoms at six to 12 months and at 12 to 24 months, change in impairment, change in any validated quality of life total score, complications of DPN, and adverse events. We assessed the certainty of the evidence using GRADE., Main Results: Our analysis incorporated three trials involving 816 participants. Two studies included people with type 1 or type 2 diabetes, while one study included only people with type 2 diabetes. The duration of treatment was between six months and 48 months. We judged all studies at high risk of overall bias due to attrition. ALA compared with placebo probably has little or no effect on neuropathy symptoms measured by TSS (lower score is better) after six months (mean difference (MD) -0.16 points, 95% confidence interval (CI) -0.83 to 0.51; 1 study, 330 participants; moderate-certainty evidence). The CI of this effect estimate did not contain the minimal clinically important difference (MCID) of 0.97 points. ALA compared with placebo may have little or no effect on impairment measured by the Neuropathy Impairment Score-Lower Limbs (NIS-LL; lower score is better) after six months (MD -1.02 points, 95% CI -2.93 to 0.89; 1 study, 245 participants; low-certainty evidence). However, we cannot rule out a significant benefit, because the lower limit of the CI surpassed the MCID of 2 points. There is probably little or no difference between ALA and placebo in terms of adverse events leading to cessation of treatment within six months (risk ratio (RR) 1.48, 95% CI 0.50 to 4.35; 3 studies, 1090 participants; moderate-certainty evidence). No studies reported quality of life or complications associated with DPN., Authors' Conclusions: Our analysis suggests that ALA probably has little or no effect on neuropathy symptoms or adverse events at six months, and may have little or no effect on impairment at six months. All the studies were at high risk of attrition bias. Therefore, future RCTs should ensure complete follow-up and transparent reporting of any participants missing from the analyses., (Copyright © 2024 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Objectives: To evaluate the support from the available guidance on reporting of health equity in research for our candidate items and to identify additional items for the Strengthening Reporting of Observational studies in Epidemiology-Equity extension., Study Design and Setting: We conducted a scoping review by searching Embase, MEDLINE, CINAHL, Cochrane Methodology Register, LILACS, and Caribbean Center on Health Sciences Information up to January 2022. We also searched reference lists and gray literature for additional resources. We included guidance and assessments (hereafter termed "resources") related to conduct and/or reporting for any type of health research with or about people experiencing health inequity., Results: We included 34 resources, which supported one or more candidate items or contributed to new items about health equity reporting in observational research. Each candidate item was supported by a median of six (range: 1-15) resources. In addition, 12 resources suggested 13 new items, such as "report the background of investigators"., Conclusion: Existing resources for reporting health equity in observational studies aligned with our interim checklist of candidate items. We also identified additional items that will be considered in the development of a consensus-based and evidence-based guideline for reporting health equity in observational studies., Competing Interests: Declaration of Competing Interest Although Luis Gabriel Cuervo is an official of the Pan American Health Organization, the views expressed in this publication are his sole responsibility and do not necessarily represent the decisions or policies of the Pan American Health Organization (PAHO/WHO)., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Our aim was to investigate if and how Cochrane nutrition reviews assess dietary adherence to a specific dietary regimen., Study Design and Setting: Cochrane nutrition reviews fulfilling the following criteria were included: systematic review of randomized controlled trials including adults and investigating the effect of caloric restriction, dietary pattern, foods, nutrients, supplements, or other nutrition-related-interventions. Extensive data extraction and descriptive statistics were conducted., Results: Overall, 226 Cochrane reviews were included. Most reviews mentioned dietary adherence in the main text (n = 174), predominantly in the Methods and Results. Dietary adherence was assessed in 76 reviews and defined in 19. It was included in the risk of bias (RoB) assessment in 20 reviews with nine using a newly created RoB domain for dietary adherence, and considered as outcome in 37 reviews. Seventy-five reviews addressed degree of adherence and five treatment effects considering the degree of adherence., Conclusion: Dietary adherence was reported in a heterogeneous manner in Cochrane nutrition reviews. Due to its high importance, we suggest that systematic reviews report the assessment and degree of dietary adherence measured in primary studies. Dietary adherence can further be examined as outcome, evaluated within the RoB (deviations from intended interventions) and included in sensitivity analyses., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension., Methods: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels., Discussion: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences., (© 2023. The Author(s).)

Objectives: Intervention integrity is the degree to which the study intervention is delivered as intended. This article presents the RIPI-f checklist (Reporting Integrity of Psychological Interventions delivered face-to-face) and summarizes its development methods. RIPI-f proposes guidance for reporting intervention integrity in evaluative studies of face-to-face psychological interventions., Study Design and Setting: We followed established procedures for developing reporting guidelines. We examined 56 documents (reporting guidelines, bias tools, and methodological guidance) for relevant aspects of face-to-face psychological intervention integrity. Eighty four items were identified and grouped as per the template for intervention description and replication (TIDieR) domains. Twenty nine experts from psychology and medicine and other scholars rated the relevance of each item in a single-round Delphi survey. A multidisciplinary panel of 11 experts discussed the survey results in three online consensus meetings and drafted the final version of the checklist., Results: We propose RIPI-f, a checklist with 50 items. Our checklist enhances TIDieR with important extensions, such as therapeutic alliance, provider's allegiance, and the adherence of providers and participants., Conclusion: RIPI-f can improve the reporting of face-to-face psychological interventions. The tool can help authors, researchers, systematic reviewers, and guideline developers. We suggest using RIPI-f alongside other reporting guidelines., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist., Design: Repeated cross sectional study., Setting: Swiss, German and Canadian research ethics committees (RECs)., Participants: RCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292)., Primary and Secondary Outcome Measures: The primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items. We compared these outcomes in protocols approved in 2012 and 2016, and built regression models to explore factors associated with adherence to SPIRIT. For each protocol, we also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reported RESULTS: The median proportion of reported SPIRIT items among RCT protocols showed a non-significant increase from 72% (IQR, 63%-79%) in 2012 to 77% (IQR, 68%-82%) in 2016. However, in a preplanned subgroup analysis, we detected a significant improvement in investigator-sponsored protocols: the median proportion increased from 64% (IQR, 55%-72%) in 2012 to 76% (IQR, 64%-83%) in 2016, while for industry-sponsored protocols median adherence was 77% (IQR 72%-80%) for both years. The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship., Conclusions: In 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve., Competing Interests: Competing interests: BvN is currently employed by Roche Pharma AG, Grenzach-Wyhlen, Germany. BK is currently employed by iOMEDICO AG, Freiburg, Germany. All other authors declare no financial relationships with any organisation that might have an interest in the submitted work and no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Objective: When a randomized clinical trial (RCT) prematurely discontinues, it is essential that stakeholders do the right thing to ensure that lessons can be learnt and trust in clinical research is maintained. There is, however, a lack of evidence exploring this issue. This study aimed to examine clinical trial stakeholders' practices following trial discontinuation due to poor participant recruitment and their views on implications of such discontinuation., Methods: Individual semi-structured qualitative interviews were conducted with 49 clinical trial stakeholders from Switzerland (n = 39), Germany (n = 9) and Canada (n = 1) between August 2015 and November 2016., Results: After interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications. However, barriers continue to undermine transparency regarding trial discontinuation in practice, with it being reported that most investigators of discontinued trials are failing to notify stakeholders or publishing their results. Investigators sense of failure and associated negative emotions were identified as a key reason why investigators are not more transparent following discontinuation., Conclusion: The decision to notify stakeholders and publish results of a discontinued clinical trial should not rest solely on individual investigators but come from a systemic approach. However, until health research proactively requires the dissemination of results of all clinical trials, much will rest on individual investigators being motivated to do the right thing. Support programs might be helpful for investigators involved in discontinued trials and promote transparency and learning lessons., (Copyright © 2022. Published by Elsevier Inc.)

Background: We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs., Methods and Findings: We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations., Conclusions: We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: DG contributed to the ASPIRE project as part of his PhD thesis before his current employment with Idorsia Pharmaceuticals Ltd. (his current employer had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript). BvN contributed to the ASPIRE project as part of her PhD thesis before her current employment with Roche (her current employer had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript). All authors have declared that no competing interests exist.