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The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials (CRTs), published in 2012, is the first and remains the only international ethics guidance document specific to CRTs. However, the stepped-wedge CRT design raises complex ethical issues for which guidance may be lacking. The overarching objective of this review is to inform the forthcoming update of the Ottawa Statement; specific objectives are to characterize the types of interventions and data collection procedures in stepped-wedge CRTs (SW-CRTs), and to examine adherence to key ethical design, conduct, and reporting recommendations. Primary reports of SW-CRTs evaluating health interventions published 2016-2022 in English were reviewed. Two reviewers extracted data from each trial independently; discrepancies were resolved through consensus. Among 160 SW-CRTs, most evaluated multilevel interventions (78, 49%), and uncommonly involved therapeutic patient interventions (19, 12%). Few (10, 6%) exclusively used routinely collected data sources for outcome assessment. Sixty-four trials (40%) provided explicit justifications for using cluster randomization and the stepped-wedge design. Most (157, 98%) included a statement about research ethics committee (REC) review, of which 148 (94%) reported approval. A statement about consent was reported in 145 (91%), with 113 (78%) pertaining to patients only, 10 (7%) to health-care providers only, and 22 (15%) to both. Among 135 trials reporting on patient consent, consent was not obtained in 55 (41%). Justifications for not obtaining consent were provided in 42 (76%). The updated Ottawa Statement should provide guidance about when people should be considered research participants and when their consent is required, justifications for using a stepped-wedge design, the need for REC review, and the burden of data collection procedures in SW-CRTs. We reviewed 160 SW-CRTs published between 2016 and 2022. These trials often evaluate multifaceted interventions delivered at the cluster or professional level rather than individual level, and most had to rely on at least some form of primary data collection. Although almost all SW-CRTs reported ethics review, fewer than half explained why they used the SW-CRT design, and a substantial minority did not include a statement about whether participant informed consent was obtained. Rarely did consent statement pertain to health-care providers; most statements pertained to patients. Among the SW-CRTs that had consent statements pertaining to patients, almost half reported not obtaining or waiving consent from them, and many of these did not report clear reasons for this. Our findings highlight the need for clearer guidance in the forthcoming update to the Ottawa Statement on the Ethical Design and Conduct of CRTs. •Stepped-wedge cluster randomized trials (SW-CRTs) raise complex ethical issues.•We reviewed 160 SW-CRTs to identify gaps in and inform an update of ethics guidelines.•We found five ethical issues raised by SW-CRTs in need of additional guidance.

Cluster randomized trials (CRTs) are frequently used to evaluate interventions in low- and middle-income countries (LMICs). Robust execution and transparent reporting of randomization procedures are essential for successful implementation and accurate interpretation of CRTs. Our objectives were to review the quality of reporting and implementation of randomization procedures in a sample of parallel-arm CRTs conducted in LMICs. We selected a random sample of 300 primary reports of parallel-arm CRTs from a database of 800 CRTs conducted in LMICs between 2017 and 2022. Data were extracted by two reviewers per trial and summarized using descriptive statistics. Among 300 trials, 192 (64%) reported the method of sequence generation, 213 (71%) reported the type of randomization procedure used, 146 (49%) reported who generated the sequence, 136 (45%) reported whether randomization was implemented by an independent person, and 75 (25%) reported a method of allocation concealment. Among those reporting the methods used, suboptimal randomization procedures were common: 28% did not use a computer, 21% did not use restricted randomization, 58% did not use a statistician to generate the sequence, in 53% the person was not independent from the trial, and 80% did not use central randomization. Public randomization ceremonies were used in 10% of trials as an alternative method of allocation concealment and to reassure participants of fair allocation procedures. The conduct and reporting of randomization procedures of CRTs in LMICs is suboptimal. Dissemination of guidance to promote robust implementation of randomization in LMICs is required, and future research on the implementation of public randomization ceremonies is warranted. Cluster randomized trials (CRTs) are trials where entire groups, rather than individuals, are randomly assigned to different treatments (eg, intervention or usual care). This randomization process can be challenging in CRTs; clear reporting and proper execution are important to ensure fairness and accurate results. In this study, we reviewed how well randomization procedures were reported and carried out in 300 CRTs, selected from a larger database of 800 CRTs, conducted in low- and middle-income countries (LMICs), and published between 2017 and 2022. We found that reporting on key aspects of randomization was often incomplete: 64% reported how they created the random allocation sequence, 71% reported the type of randomization method used, 49% reported who generated the sequence, 45% reported whether a person independent from the trial handled the randomization, and 25% reported how they kept group assignments hidden until the intervention was ready to begin. Even when trials did reported these methods, many did not follow best practices: 28% did not use a computer, 21% did not apply techniques to ensure balanced treatment arms, 58% did not involve a statistician to generate the sequence, 53% had someone involved in the trial handle randomization (as opposed to an independent person), and 80% did not use central randomization to assign groups, where a third party reveals treatment assignment to groups. Interestingly, 10% of trials used public randomization ceremonies (events where group assignments are revealed in a public setting) to keep group assignments hidden until revealment and to reassure participants that the process was fair. Overall, we found that randomization procedures in CRTs were often not well reported or carried out optimally. It is important for researchers to follow established guidelines to ensure randomization is done properly in CRTs in LMICs. More research is also needed to understand how public randomization ceremonies are used in practice. [Display omitted] •Robust randomization methods are essential for cluster randomized trials (CRTs).•Improved adherence to reporting and best practices for randomization in CRTs is needed.•Public randomization ceremonies may help with implementation challenges.•Further research on the conduct of public randomization ceremonies is warranted.

ObjectiveThe present study aimed to appraise the methodological quality of evidence-based Clinical Practice Guidelines (CPGs) in the cariology field.Materials and methodsA systematic search on electronic databases (MEDLINE/Pubmed, EMBASE, DARE and Epistemonikos), websites, and guideline organizations were undertaken. Evidence-based CPGs including at least one recommendation for clinical prevention and/or management of dental caries, developed for any clinical setting, were included. The quality of each guideline was evaluated using the AGREE II tool. Descriptive analysis was performed and the average overall score for each domain was calculated.ResultsThirty-two guidelines were included. Most of the CPGs achieved higher scores for the domains of clarity of presentation (66.7%, 95% IC 37.3–52.2) and scope and purpose (59.6%, 95% IC 53.7–65.5) domains; and lower scores for editorial independence (46.1%, 95% IC 37.8–55.7) and applicability domain (44.7%, 95% IC 37–55.3). The reviewers assessed 12 CPGs (37.5%) as recommended for use, 15 (46.9%) recommended with modifications, and 5 (15.6%) as not recommended.ConclusionThe overall methodological quality of evidence-based CPGs in the cariology field is moderate, and there is a need for improvements in reporting related to most domains. The poorest reporting was found in the description of the domains’ applicability of its recommendations and editorial independence.Clinical relevanceClinical Practice Guidelines provide guidance to patients, healthcare professionals, and stakeholders. The quality of these documents is essential for establishing trust in their recommendations.