Abstract
BackgroundRecruitment to trials can be difficult. Despite careful planning and research that outlines ways to improve recruitment, many trials do not achieve their target on time and require extensions of funding or time.MethodsWe describe a trial in which an internal pilot with embedded qualitative research was used to improve recruitment processes and inform recruitment projections for the main trial. At the end of the pilot, it was clear that the sample size would not be met on time. Three steps were taken to optimise recruitment: (1) adjustments were made to the recruitment process using information from the qualitative work done in the pilot and advice from a patient and public involvement group, (2) additional recruiting sites were included based on site feasibility assessments and (3) a projection equation was used to estimate recruitment at each site and overall trial recruitment.ResultsQualitative work during the pilot phase allowed us to develop strategies to optimise recruitment during the main trial, which were incorporated into patient information packs, the standard operating procedures and training sessions with recruiters. From our experience of feasibility assessments, we developed a checklist of recommended considerations for feasibility assessments. For recruitment projections, we developed a four-stage projection equation that estimates the number of participants recruited using a conversion rate of the number randomised divided by the number screened.ConclusionsThis work provides recommendations for feasibility assessments and an easy-to-use projection tool, which can be applied to other trials to help ensure they reach the required sample size.Trial registrationISRCTN, ISRCTN92545361. Registered on 6 September 2016.
Highlights
Our aim is to provide an overview of implementable methods of optimising recruitment, which research teams can use to increase the likelihood that recruitment targets are met
Using purposive sampling [31] to ensure that data were elicited from patients and recruiters from a variety of trial sites, we aimed to record 30 recruitment consultations and conduct telephone follow-up interviews with 30 participants to explore their experience of trial recruitment and to identify facilitators and barriers to recruitment and retention, and the accessibility of trial information
At the end of the pilot, we reviewed the findings with the group, who made recommendations about patient involvement in researcher training and updates to recruitment standard operating procedures, including how to explain usual care
Summary
Despite careful planning and research that outlines ways to improve recruitment, many trials do not achieve their target on time and require extensions of funding or time. Good estimates of recruitment targets are needed. This enables study timeframes and budgets to be properly calculated and enables practicalities, such as the number of study centres, to be planned for. Many trials struggle to achieve their recruitment targets within the expected timeframe. Numerous trials have stopped because they have not been able to recruit sufficient participants or have finished with fewer participants than planned [2]. Extensions of time and funding are required in around
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