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Determining sample size for progression criteria for pragmatic pilot RCTs: The Hypothesis test Strikes Back! by Martyn Lewis; Kieran Bromley; Christopher J Sutton; Gareth McCray; Helen Lucy Myers; Gillian A Lancaster is a scholarly article available to read on EtoBox.

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## Abstract Background The current CONSORT guidelines for reporting pilot trials do not recommend hypothesis testing of clinical outcomes on the basis that a pilot trial is under-powered to detect such differences and this is the aim of the main trial. It states that primary evaluation should focus on descriptive analysis of feasibility/process outcomes (e.g. recruitment, adherence, treatment fidelity). Whilst the argument for not testing clinical outcomes is justifiable, the same does not necessarily apply to feasibility/process outcomes, where differences may be large and detectable with small samples. Moreover, there remains much ambiguity around sample size for pilot trials. Methods Many pilot trials adopt a ‘traffic light’ system for evaluating progression to the main trial determined by a set of criteria set up a priori. We construct a hypothesis-testing approach for binary feasibility outcomes focused around this system that tests against being in the RED zone (unacceptable outcome) based on an expectation of being in the GREEN zone (acceptable outcome) and choose the sample size to give high power to reject being in the RED zone if the GREEN zone holds true. Pilot point est

Author

Martyn Lewis; Kieran Bromley; Christopher J Sutton; Gareth McCray; Helen Lucy Myers; Gillian A Lancaster

Publisher

Research Square Platform LLC

Published

2021

Language

EN