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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Series: Pragmatic trials and real world evidence: Paper 6. Outcome measures in the real world
Journal of Clinical Epidemiology, Volume 90, Year 2017
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Description
Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore, pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This sixth article in the series (see Box) discusses different types of outcomes and their suitability for pragmatic trials, design choices for measuring these outcomes, and their implications and challenges. Measuring outcomes in pragmatic trials should not interfere with real-world clinical practice to ensure generalizability of trial results, and routinely collected outcomes should be prioritized. Typical outcomes include mortality, morbidity, functional status, well-being, and resource use. Surrogate endpoints are typically avoided as primary outcome. It is important to measure outcomes over a relevant time horizon and obtain valid and precise results. As pragmatic trials are often open label, a less subjective outcome can reduce bias. Methods that decrease bias or enhance precision of the results, such as standardization and blinding of outcome assessment, should be considered when a high risk of bias or high variability is expected. The selection of outcomes in pragmatic trials should be relevant for decision making and feasible in terms of executing the trial in the context of interest. Therefore, this should be discussed with all stakeholders as early as feasible to ensure the relevance of study results for decision making in clinical practice and the ability to perform the study. © 2017 The Authors
Authors & Co-Authors
Eckert, Laurent
France, Gentilly
Sanofi S.a.
Van Smeden, Maarten
Netherlands, Utrecht
University Medical Center Utrecht
Ciaglia, Antonio
Unknown Affiliation
Trelle, Sven
Switzerland, Bern
University of Bern
Taylor, Aliki Joanna
Unknown Affiliation
Egger, Matthias
Switzerland, Bern
University of Bern
Statistics
Citations: 33
Authors: 6
Affiliations: 5
Identifiers
Doi:
10.1016/j.jclinepi.2016.12.022
ISSN:
08954356