Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question : STOPIT-3 study design
Prutsky, Gabriela J. (Wayne State University School of Medicine/Detroit Medical Center (Estats Units d'Amèrica))
Domecq, Juan Pablo (Henry Ford Hospital (Estats Units d'Amèrica))
Erwin, Patricia J. (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Briel, Matthias (McMaster University (Suïssa))
Montori, Victor M. (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Akl, Elie A. (State University of New York at Buffalo (Estats Units d'Amèrica))
Meerpohl, Joerg J. (University Medical Center Freiburg (Alemanya))
Bassler, Dirk (University Children's Hospital Tuebingen (Suïssa))
Schandelmaier, Stefan (University Hospital Basel (Basilea, Suïssa))
Walter, Stephen D. (McMaster University (Canadà))
Zhou, Qi (McMaster University (Canadà))
Alonso-Coello, Pablo (Institut d'Investigació Biomèdica Sant Pau)
Moja, Lorenzo (IRCCS Galeazzi Orthopedic Institute (Itàlia))
Walter, Martin A. (University Hospital Bern (Suïssa))
Thorlund, Kristian (McMaster University (Canadà))
Glasziou, Paul (University of Oxford)
Kunz, Regina (University Hospital Basel (Basilea, Suïssa))
Ferreira-Gonzalez, Ignacio (Hospital Universitari Vall d'Hebron)
Busse, Jason (McMaster University (Canadà))
Sun, Xin (Kaiser Permanente Northwest (Xina))
Kristiansen, Annette (Norwegian Knowledge Centre for the Health Services (Noruega))
Kasenda, Benjamin (University Hospital Basel (Basilea, Suïssa))
Qasim-Agha, Osama (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Pagano, Gennaro (Federico II University of Naples (Itàlia))
Pardo-Hernandez, Hector (Institut d'Investigació Biomèdica Sant Pau)
Urrútia, Gerard (Institut d'Investigació Biomèdica Sant Pau)
Murad, Mohammad Hassan (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Guyatt, Gordon (McMaster University (Canadà))
Universitat Autònoma de Barcelona

Data:	2013
Resum:	Background: Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or planned RCTs respond to the publication of a truncated RCT addressing a similar question. Methods/design: We will conduct systematic reviews to update the searches of 210 truncated RCTs to identify similar trials ongoing at the time of publication, or started subsequently, to the truncated trials ('subsequent RCTs'). Reviewers will determine in duplicate the similarity between the truncated and subsequent trials. We will analyze the epidemiology, distribution, and predictors of subsequent RCTs. We will also contact authors of subsequent trials to determine reasons for beginning, continuing, or prematurely discontinuing their own trials, and the extent to which they rely on the estimates from truncated trials. Discussion: To the extent that investigators begin or continue subsequent trials they implicitly disagree with the decision to stop the truncated RCT because of an ethical mandate to administer the experimental treatment. The results of this study will help guide future decisions about when to stop RCTs early for benefit. © 2013 Prutsky et al. ; licensee BioMed Central Ltd.
Nota:	This systematic review was funded by the Knowledge and Evaluation Research Unit (KER), Mayo Clinic, MN, USA.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Protocol ; Randomized controlled trials stopped early for benefit ; RCT ; Systematic review
Publicat a:	Trials, Vol. 14 Núm. 1 (16 2013) , p. 335, ISSN 1745-6215

DOI: 10.1186/1745-6215-14-335
PMID: 24131702

8 p, 964.5 KB

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