Series: Pragmatic trials and real world evidence: Paper 3. Patient selection challenges and consequences

Journal of Clinical Epidemiology
Katrien Oude RengerinkWork Package 3 of the GetReal consortium

Abstract

This 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 fol...Continue Reading

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May 16, 2017·Journal of Clinical Epidemiology·Paco M WelsingUNKNOWN Work Package 3 of the GetReal Consortium
May 23, 2019·Journal of Gastroenterology and Hepatology·Vincent Chi Ho ChungJustin Che Yuen Wu
Jan 14, 2020·Advances in Therapy·David A LeatherMike Thomas
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Jul 21, 2020·Physiotherapy Theory and Practice·Madeleine KennyCarl Thompson
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Jul 27, 2020·Journal of the American College of Cardiology·Guillaume Marquis-GravelShaun G Goodman
Nov 3, 2021·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Paul A CohenKellie Bennett

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