• Katrien Oude Rengerink, Shona Kalkman, Susan Collier, Antonio Ciaglia, Sally D Worsley, Alison Lightbourne, Laurent Eckert, GroenwoldRolf H HRHHJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Utrecht 3584 CG, The Netherlands., Diederick E Grobbee, Elaine A Irving, and Work Package 3 of the GetReal consortium.
• Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Utrecht 3584 CG, The Netherlands. Electronic address: k.ouderengerink-2@umcutrecht.nl.
• J Clin Epidemiol. 2017 Sep 1; 89: 173-180.

AbstractThis paper addresses challenges of identifying, enrolling, and retaining participants in a trial conducted within a routine care setting. All patients who are potential candidates for the treatments in routine clinical practice should be considered eligible for a pragmatic trial. To ensure generalizability, the recruited sample should have a similar distribution of the treatment effect modifiers as the target population. In practice, this can be best achieved by including-within the selected sites-all patients without further selection. If relevant heterogeneity between subgroups is expected, increasing the relative proportion of the subgroup of patients in the heterogeneous trial could be considered (oversampling) or a separate trial in this subgroup can be planned. Selection will nevertheless occur. Low enrollment and loss to follow-up can introduce selection and can jeopardize validity as well as generalizability. Pragmatic trials are conducted in clinical practice rather than in a dedicated research setting, which could reduce recruitment rates. However, if a trial poses a minimal burden to the physician and the patient and routine clinical practice is maximally adhered to, the participation rate may be high and loss to follow-up will not be a specific problem for pragmatic trials.Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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