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Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.
(BMJ, 2021-06-28)
OBJECTIVES: Prespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria ...
Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study.
(BioMed Central, 2021-04-16)
BACKGROUND: Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies. METHODS: Here, we aimed ...
Pilot and feasibility studies for pragmatic trials have unique considerations and areas of uncertainty.
(2021-07-03)
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 ...