Abstract
Background and objective
Feasibility studies are increasingly being used to support the development of, and
investigate uncertainties around, future large-scale trials. The future trial can
be designed with either a pragmatic or explanatory mindset. Whereas pragmatic trials
aim to inform the choice between different care options and thus, are designed to
resemble conditions outside of a clinical trial environment, explanatory trials examine
the benefit of a treatment under more controlled conditions. There is existing guidance
for designing feasibility studies, but none that explicitly considers the goals of
pragmatic designs. We aimed to identify unique areas of uncertainty that are relevant
to planning a pragmatic trial.
Results
We identified ten relevant domains, partly based on the pragmatic-explanatory continuum
indicator summary-2 (PRECIS-2) framework, and describe potential questions of uncertainty
within each: intervention development, research ethics, participant identification
and eligibility, recruitment of individuals, setting, organization, flexibility of
delivery, flexibility of adherence, follow-up, and importance of primary outcome to
patients and decision-makers. We present examples to illustrate how uncertainty in
these domains might be addressed within a feasibility study.
Conclusion
Researchers planning a feasibility study in advance of a pragmatic trial should consider
feasibility objectives specifically relevant to areas of uncertainty for pragmatic
trials.
Keywords
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Article info
Publication history
Published online: July 03, 2021
Accepted:
June 29,
2021
Identification
Copyright
© 2021 Elsevier Inc. All rights reserved.
