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Premature Discontinuation of Pediatric Randomized Controlled Trials: A Retrospective Cohort Study.
Schandelmaier, Stefan; Tomonaga, Yuki; Bassler, Dirk; Meerpohl, Joerg J; von Elm, Erik; You, John J; Bluemle, Anette; Lamontagne, Francois; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Sun, Xin; Busse, Jason W; Ferreira-González, Ignacio; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Guyatt, Gordon; Bucher, Heiner C; Kasenda, Benjamin; Briel, Matthias.
Afiliação
  • Schandelmaier S; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Academy of Swiss Insurance Medicine, University Hospital Basel, Basel, Switzerland. Elec
  • Tomonaga Y; Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
  • Bassler D; Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
  • Meerpohl JJ; German Cochrane Centre, Medical Center, University of Freiburg, Freiburg, Germany; Center of Research in Epidemiology and Statistics Sorbonne Paris Cité-U1153, INSERM/Université Paris Descartes, Cochrane France, Hôpital Hôtel-Dieu, Paris Cedex 04, France.
  • von Elm E; Cochrane Switzerland, Institute of Social and Preventive Medicine, Lausanne University Hospital, Lausanne, Switzerland.
  • You JJ; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
  • Bluemle A; German Cochrane Centre, Medical Center, University of Freiburg, Freiburg, Germany.
  • Lamontagne F; Centre de Recherche Clinique du Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC, Canada.
  • Saccilotto R; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Amstutz A; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Bengough T; Department of Health and Society, Austrian Federal Institute for Health Care, Vienna, Austria.
  • Stegert M; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Olu KK; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Tikkinen KAO; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Departments of Urology and Public Health, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
  • Neumann I; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Internal Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.
  • Carrasco-Labra A; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile.
  • Faulhaber M; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
  • Mulla SM; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
  • Mertz D; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Infectious Diseases Research, McMaster University, Hamilton, ON, Canada.
  • Akl EA; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.
  • Sun X; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
  • Busse JW; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Anesthesia, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada.
  • Ferreira-González I; Epidemiology Unit, Department of Cardiology, Vall d'Hebron Hospital and CIBER de Epidemiología y Salud Publica (CIBERESP), Barcelona, Spain.
  • Nordmann A; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Gloy V; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland; Institute of Nuclear Medicine, University Hospital Bern, Bern, Switzerland.
  • Raatz H; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Moja L; IRCCS Orthopedic Institute Galeazzi, Milano, Italy.
  • Rosenthal R; Department of Surgery, University Hospital Basel, Basel, Switzerland.
  • Ebrahim S; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Anesthesia, McMaster University, Hamilton, ON, Canada; Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada; Stanfor
  • Vandvik PO; Department of Medicine, Innlandet Hospital Trust-Division Gjøvik, Oppland, Norway.
  • Johnston BC; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, Dalla Lana School of
  • Walter MA; Institute of Nuclear Medicine, University Hospital Bern, Bern, Switzerland.
  • Burnand B; Cochrane Switzerland, Institute of Social and Preventive Medicine, Lausanne University Hospital, Lausanne, Switzerland.
  • Schwenkglenks M; Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
  • Hemkens LG; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Guyatt G; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
  • Bucher HC; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
  • Kasenda B; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland; Department of Haematology/Oncology and Palliative Care, Klinikum Stuttgart, Stuttgart, Germany.
  • Briel M; Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Clinical Research, University of Basel, Basel, Switzerland.
J Pediatr ; 184: 209-214.e1, 2017 05.
Article em En | MEDLINE | ID: mdl-28410086
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Término Precoce de Ensaios Clínicos Tipo de estudo: Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Aspecto: Ethics Limite: Child / Humans País/Região como assunto: America do norte / Europa Idioma: En Revista: J Pediatr Ano de publicação: 2017 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Término Precoce de Ensaios Clínicos Tipo de estudo: Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Aspecto: Ethics Limite: Child / Humans País/Região como assunto: America do norte / Europa Idioma: En Revista: J Pediatr Ano de publicação: 2017 Tipo de documento: Article