CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

Home-based health promotion for older people with mild frailty: the HomeHealth intervention development and feasibility RCT

“…As the aim of the study is to assess the feasibility of collecting data for a full trial of HomeHealth and given the small sample size, we have not reported incremental cost-effectiveness ratios or cost-effectiveness curves as this would imply hypothesis testing of the cost-effectiveness of HomeHealth compared with TAU, which is not recommended for feasibility trials. 242 …”

“…In line with the Consolidated Standards of Reporting Trials (CONSORT) feasibility study statement, 242 we outline the flow of participants through the study and baseline and outcome data for each trial group. We report a definition of 'treatment as usual' from our control arm for use in a future RCT in this chapter, and the acceptability of the intervention itself later in the report (see Chapter 6, Process evaluation).…”

Web-Based Tailored Intervention to Support Optimal Medication Adherence Among Kidney Transplant Recipients: Pilot Parallel-Group Randomized Controlled Trial (Preprint)

“…The participant timeline, based on the CONSORT statement [13], is illustrated in Figure 1. Approximately 600 flyers were distributed by transplantation unit staff to patients visiting the hospital for their usual follow-up.…”

“…The study was approved by the Research Ethics Board of the Centre Hospitalier de l'Université de Montréal (CHUM). The RCT was reported according to the CONSORT statement guidelines for randomised pilot and feasibility trials [13].…”

A Feasibility Study of Taste & See: A Church Based Programme to Develop a Healthy Relationship with Food

“…As this is a feasibility study, we aimed to recruit at least ten participants to test the practicality of recruiting for and running this trial within a church and to determine effect sizes of outcomes [14]. A sample size of 10 would also provide 80% power at an alpha level of 0.05 in order to detect a large difference in the weight loss outcome (5 kg (SD = 5) at a rate of 0.5 kg per week).…”