2131Pragmatic clinical trials in cardiovascular medicine: trends over time in major medical journals
Notice bibliographique
Résumé
Abstract Background Pragmatic trials provide results that may be more applicable to the population in which the intervention will be eventually applied and are discussed extensively in the current healthcare environment. The aim of this study was to investigate how pragmatic or explanatory cardiovascular (CV) randomized controlled trials (RCT) are, if this was changing over time, and if they were more or less likely to meet their primary endpoint. Methods Using the six top-ranked (based on impact factors) medical and CV journals, all CV-related RCTs that were published during the years of 2000, 2005, 2010 and 2015 were identified, data extracted and reviewed by 2 adjudicators. The PRECIS-2 tool was used to evaluate the level of pragmatism. PRECIS-2 uses a 5-point ordinal scale (ranging from very pragmatic to very explanatory) across 9 domains of trial design, including eligibility, recruitment, setting, organization, intervention delivery, intervention adherence, follow-up, primary outcome, and analysis. A higher score indicates a more pragmatic score on an individual domain, and aggregated scores are a simplified formula across all domains. Cohen's D was used to quantify the mean difference relative to the variation. Results There were 616 RCTs, distributed evenly over the 2 decades, and 64% achieved their primary endpoint. The mean (±SD) PRECIS-2 score was 3.26±0.70 among 616 included RCTs. The level of pragmatism increased over time from a score of 3.07±0.74 in 2000 to 3.47±0.67 in 2015 (p<0.0001 for trend; Cohen's D relative effect size 0.57). The increase in pragmatism occurred mainly in the domains of eligibility, setting, intervention delivery, and primary endpoint (Figure). PRECIS-2 score was higher for neutral trials than those with positive results (p=0.0015) and in phase III/IV trials as compared to phase I/II trials (p<0.0001) (Figure). Furthermore, trials that involve more sites, with larger sample sizes, longer follow-ups, and those with mortality as the primary endpoint were found to be more pragmatic. There was no difference in the level of pragmatism between different sources of funding (public, industry, or both; p=0.52). Study characteristics and pragmatism Conclusion The PRECIS-2 tool can be used for appraising trials to assess their placement in the pragmatic-explanatory continuum. The level of pragmatism increased over time in CV trials. Greater focus on the design and delivery of CV trials will be required for the broad application. Acknowledgement/Funding Dr. Sepehrvand receives scholarship from Alberta Innovates Health Solutions.
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 | 0,185 | 0,607 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,003 |
| Bibliométrie | 0,032 | 0,053 |
| Études des sciences et des technologies | 0,001 | 0,003 |
| Communication savante | 0,010 | 0,007 |
| Science ouverte | 0,002 | 0,006 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
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; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».