170 SPIRIT-outcomes and CONSORT-outcomes: enhanced trial outcome transparency, less bias, improved systematic reviews, better health
Notice bibliographique
Résumé
Objectives Clinicians, patients, and policy makers rely on published results from clinical trials to help inform evidence-based decision-making. To be able to critically evaluate and use the results of trials, readers require complete and transparent information with respect to what was planned, what was done, and what was found. Inadequate reporting of trials is well-documented in the medical literature, including for study outcomes. Key information about the selection process, definition, measurement, and analysis of outcomes is often missing or poorly reported in trial protocols and subsequent published reports. Complete reporting of the investigated trial outcomes enables reproducibility of results, knowledge synthesis efforts, and prevents outcome switching and other reporting biases - ultimately helping to facilitate uptake of trial results into clinical practice. The objective of this international project was to develop the SPIRIT- and CONSORT-Outcomes reporting guidelines to provide harmonized guidance for describing outcomes in trial protocols and reports, respectively. Method We developed the SPIRIT- and CONSORT-Outcomes reporting guidelines using the EQUATOR framework for health research reporting guidelines. This included the generation and evaluation of candidate outcome reporting items via expert consultations, a scoping review, a three-round international Delphi survey, and a two-day in-person expert Consensus Meeting. A diverse group of stakeholders was involved throughout the process including those with experience in the design, conduct, oversight, publication, and interpretation of clinical trials (e.g., trialists, biostatisticians, health economists, trial registries, research ethics board members, epidemiologists) and stakeholders who use the results of clinical trial reports (e.g. journal editors, clinicians, systematic review authors, health technology assessors). Additional stakeholders, i.e., patient and public representatives and research funders, contributed to guideline development during the Consensus Meeting. Results We identified 133 outcome reporting items from the scoping review and expert consultations, the majority of which are not currently included in CONSORT or SPIRIT reporting guidelines. Items were consolidated into 67 candidate items for Delphi voting, which was completed by 124 participants from 22 countries. After the Delphi survey, 19 items met criteria for further evaluation at the Consensus Meeting for inclusion in CONSORT-Outcomes and 30 for inclusion in SPIRIT-Outcomes. The Consensus Meeting and post-Consensus Meeting finalization process ultimately yielded 8 SPIRIT-Outcomes and 16 CONSORT-Outcomes extension items. Items focused on outcome-specific issues such as those relating to outcome definition, rationale of outcome selection, components of composite outcomes, minimal important difference and change, measurement properties of study instruments, outcome assessors, and planned adjustments for multiplicity. Conclusions The SPIRIT- and CONSORT-Outcomes reporting extensions provide harmonized recommendations for outcome-specific information that should be addressed and included in clinical trial protocols and published clinical trial reports. Use and implementation of these extensions by trial authors, peer reviewers, journals, research funders, and other end-users promises to help enhance trial utility, reproducibility, and minimize the risk of selective reporting, thus reducing research waste.
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 | 0,562 | 0,643 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,002 |
| Méta-épidémiologie (sens large) | 0,003 | 0,007 |
| Bibliométrie | 0,010 | 0,011 |
| Études des sciences et des technologies | 0,003 | 0,011 |
| Communication savante | 0,017 | 0,013 |
| Science ouverte | 0,004 | 0,016 |
| Intégrité de la recherche | 0,009 | 0,009 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,014 | 0,008 |
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 ».