Exploring feedback from research nurses in relation to the design and conduct of a randomised controlled trial of wound care treatments:a sequential, dependent, mixed-methods study

Background Research nurse involvement in trials is crucial to successful conduct, however their feedback on trial design and conduct is not necessarily always collected and shared. This study was designed to explore research nurse feedback in relation to study and protocol design and implementation in the National Institute for Health Research Programme Grants for Applied Research funded Surgical Wounds Healing by Secondary Intention pilot and feasibility trial (SWHSI). The primary aim of this study was to inform the design and conduct of a proposed future, larger study in this area. Given the evidence gap, it was deemed prudent to share these findings for the benefit of others. Methods A sequential, dependent mixed methods study, comprising a Likert scale questionnaire and semi-structured interviews, explored the experiences, in relation to study design and conduct, of research nurses involved in the trial. Of the 10 research nurses involved in the trial, eight nurses completed a questionnaire and were interviewed. Questionnaire data was analysed using descriptive statistics and interview data using thematic analysis. Results A range of questionnaire responses were provided, however at least 50% (n=4) of respondents indicated that they were happy with both the study design and conduct. Interview data identified key themes to consider when involving research nurses in the design, delivery and conduct of RCTs; removing barriers to recruitment, time management, engagement strategies and resource provision. Conclusion Engagement of research nurses is important to enable effective trial conduct. Research teams should therefore consider how best to obtain and include input from all members of the research team from the outset. Furthermore, the sharing of feedback on research design and conduct, from the perspective of research nurses delivering trial recruitment and retention, remains crucial to effective and efficient trial conduct. Trial Registration: Clinical Trial Registry: ISRCTN12761776. Date of registration: 10th December 2015. Key Words: Randomised controlled trial, mixed methods, research conduct, nurses, experiences