A methodological survey on reporting of pilot and feasibility trials for physiotherapy interventions: a study protocol.

Abstract

Pilot and feasibility trials aim to test whether a full trial can be conducted or if any procedures must be changed for the full trial. Pilot trials must be reported in a transparent, accurate and complete way. In this report, we present a protocol for a methodological survey with the following aims: (1) to determine the percentage of physiotherapy trial reports which claim to be pilot or feasibility trials that evaluate feasibility, (2) to determine the aspect of feasibility evaluated in the primary objectives of the pilot or feasibility trials, (3) to describe the completeness of reporting of abstracts and full articles of pilot or feasibility trials using the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials and (4) to investigate factors associated with completeness of reporting of pilot or feasibility trials. Reports of randomised controlled trials indexed in the Physiotherapy Evidence Database (PEDro) that claim to be pilot or feasibility trials and published in 2011-2017 will be included. Two independent reviewers will confirm eligibility and classify the aspect of feasibility being evaluated in the objectives of the included pilot or feasibility trials. Completeness of reporting of both the abstract and the full article will be evaluated using the CONSORT extension to randomised pilot and feasibility trials. The primary analysis will be a descriptive analysis about the reporting quality of abstracts and full texts of pilot and feasibility trials. We will use generalised estimating equation analysis to explore factors associated with completeness of reporting. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. Ethical approval is not necessary for this study.