Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study.

Détails

ID Serval
serval:BIB_6191BF22644A
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study.
Périodique
Critical Care Medicine
Auteur⸱e⸱s
Schandelmaier S., von Elm E., You J.J., Blümle A., Tomonaga Y., Lamontagne F., Saccilotto R., Amstutz A., Bengough T., Meerpohl J.J., Stegert M., Olu K.K., Tikkinen K.A., Neumann I., Carrasco-Labra A., Faulhaber M., Mulla S.M., Mertz D., Akl E.A., Sun X., Bassler D., Busse J.W., Ferreira-González I., Nordmann A., Gloy V., Raatz H., Moja L., Rosenthal R., Ebrahim S., Vandvik P.O., Johnston B.C., Walter M.A., Burnand B., Schwenkglenks M., Hemkens L.G., Cook D.J., Meade M.O., Bucher H.C., Kasenda B., Briel M.
ISSN
1530-0293 (Electronic)
ISSN-L
0090-3493
Statut éditorial
Publié
Date de publication
2016
Peer-reviewed
Oui
Volume
44
Numéro
1
Pages
130-137
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
OBJECTIVES: Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials.
DESIGN: Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003.
SETTING: Randomized clinical trials involving patients in an acute or nonacute care setting.
SUBJECTS AND INTERVENTIONS: We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators.
MEASUREMENTS AND MAIN RESULTS: Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size.
CONCLUSIONS: Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.
Mots-clé
Canada, Cohort Studies, Early Termination of Clinical Trials/trends, Emergency Treatment, Germany, Humans, Randomized Controlled Trials as Topic/statistics & numerical data, Retrospective Studies, Switzerland
Pubmed
Web of science
Création de la notice
23/10/2015 11:00
Dernière modification de la notice
20/08/2019 15:18
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