Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel

Eva Isaksson, Per Wester, Ann Charlotte Laska, Per Näsman, Erik Lundström, Eva Isaksson, Per Wester, Ann Charlotte Laska, Per Näsman, Erik Lundström

Abstract

Background: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT.

Methods: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively.

Results: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%).

Conclusions: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.

Trial registration: The protocol for this study was registered at the Northern Ireland Hub for trials methodology research (SWAT ID 64 ). The EFFECTS study has EudraCT number 2011-006130-16 and was registered 17 February 2016 at ClinicalTrials.gov number NCT02683213 .

Keywords: Questionnaire; RCT; Randomised controlled trials; Recruitment; Survey.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The process of developing the questionnaire
Fig. 2
Fig. 2
A question in the questionnaire
Fig. 3
Fig. 3
participant flow diagram

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Source: PubMed

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