Identifying ethical issues in stepped-wedge cluster randomized trials to inform the Ottawa Statement update: a systematic review of trials published 2016–2022
Notice bibliographique
Résumé
OBJECTIVES: 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. STUDY DESIGN AND SETTING: 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. RESULTS: 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%). CONCLUSION: 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. PLAIN LANGUAGE SUMMARY: 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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,650 | 0,836 |
| Méta-épidémiologie (sens strict) | 0,003 | 0,006 |
| Méta-épidémiologie (sens large) | 0,015 | 0,014 |
| Bibliométrie | 0,021 | 0,019 |
| Études des sciences et des technologies | 0,006 | 0,012 |
| Communication savante | 0,020 | 0,017 |
| Science ouverte | 0,011 | 0,010 |
| Intégrité de la recherche | 0,012 | 0,010 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 0,002 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; l’étiquette directe de Gemma et le classifieur distillé Codex s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».