Premature Discontinuation of Pediatric Randomized Controlled Trials : a Retrospective Cohort Study
Articolo
Data di Pubblicazione:
2017
Citazione:
Premature Discontinuation of Pediatric Randomized Controlled Trials : a Retrospective Cohort Study / S. Schandelmaier, Y. Tomonaga, D. Bassler, J..J. Meerpohl, E. Von Elm, J..J. You, A. Bluemle, F. Lamontagne, R. Saccilotto, A. Amstutz, T. Bengough, M. Stegert, K..K. Olu, K..A..O. Tikkinen, I. Neumann, A. Carrasco Labra, M. Faulhaber, S..M. Mulla, D. Mertz, E..A. Akl, X. Sun, J..W. Busse, I. Ferreira González, A. Nordmann, V. Gloy, H. Raatz, P. Moja, R. Rosenthal, S. Ebrahim, P..O. Vandvik, B..C. Johnston, M..A. Walter, B. Burnand, M. Schwenkglenks, L..G. Hemkens, G. Guyatt, H..C. Bucher, B. Kasenda, M. Briel. - In: THE JOURNAL OF PEDIATRICS. - ISSN 0022-3476. - 184(2017), pp. 209-214.
Abstract:
Objectives To determine the proportion of pediatric randomized controlled trials (RCTs) that are prematurely discontinued, examine the reasons for discontinuation, and compare the risk for recruitment failure in pediatric and adult RCTs. Study design A retrospective cohort study of RCTs approved by 1 of 6 Research Ethics Committees (RECs) in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics, trial discontinuation, and reasons for discontinuation from protocols, corresponding publications, REC files, and a survey of trialists. Results We included 894 RCTs, of which 86 enrolled children and 808 enrolled adults. Forty percent of the pediatric RCTs and 29% of the adult RCTs were discontinued. Slow recruitment accounted for 56% of pediatric RCT discontinuations and 43% of adult RCT discontinuations. Multivariable logistic regression analyses suggested that pediatric RCT was not an independent risk factor for recruitment failure after adjustment for other potential risk factors (aOR, 1.22; 95% CI, 0.57-2.63). Independent risk factors were acute care setting (aOR, 4.00; 95% CI, 1.72-9.31), nonindustry sponsorship (aOR, 4.45; 95% CI, 2.59-7.65), and smaller planned sample size (aOR, 1.05; 95% CI 1.01-1.09, in decrements of 100 participants). Conclusion Forty percent of pediatric RCTs were discontinued prematurely, owing predominately to slow recruitment. Enrollment of children was not an independent risk factor for recruitment failure.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
early termination of clinical trials (MeSH); pediatrics (MeSH); randomized controlled trials as a topic (MeSH); risk factors (MeSH); Pediatrics, Perinatology and Child Health
Elenco autori:
S. Schandelmaier, Y. Tomonaga, D. Bassler, J..J. Meerpohl, E. Von Elm, J..J. You, A. Bluemle, F. Lamontagne, R. Saccilotto, A. Amstutz, T. Bengough, M. Stegert, K..K. Olu, K..A..O. Tikkinen, I. Neumann, A. Carrasco Labra, M. Faulhaber, S..M. Mulla, D. Mertz, E..A. Akl, X. Sun, J..W. Busse, I. Ferreira González, A. Nordmann, V. Gloy, H. Raatz, P. Moja, R. Rosenthal, S. Ebrahim, P..O. Vandvik, B..C. Johnston, M..A. Walter, B. Burnand, M. Schwenkglenks, L..G. Hemkens, G. Guyatt, H..C. Bucher, B. Kasenda, M. Briel
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