What are research nurses' experiences of obtaining consent from or for patients participating in emergency care research? A qualitative review

Abstract

Introduction If studies are to be valid, recruitment of representative samples is essential. In 2012, 28% of UK emergency departments met the 80% standard for recruitment to trials set by the National Institute for Health Research. Research nurses play a vital role in the conduct of high‐quality research, and it has been argued that dedicated research nurses are needed if clinical trials are to recruit successfully to target. Review question What are research nurses' experiences of obtaining consent from or for patients participating in emergency care research? A qualitative evidence review. Methods A qualitative integrative literature review with a narrative synthesis of the evidence. PRISMA guidelines for reporting systematic qualitative reviews (Appendix S1) were followed. A search of five electronic databases was performed in December 2018 along with a hand search which yielded 125 citations: 10 papers and one PhD thesis met the review eligibility criteria. Methodological quality of the selected studies was evaluated, and data were extracted and synthesised. Results Three themes were identified: Access, Organisation and Timing. Research nurses encountered both general and specific barriers when seeking to obtain consent for participation in research. In particular, it was found there was lack of experience among staff of working in emergency research and with securing deferred consent. The distinction between nurse researchers with a clinical role and those dedicated to solely to research only is often not clear and warrants further investigation. Conclusion Nurse researchers with and without a clinical role can make a positive difference in recruitment to trials in emergency care. The involvement of dedicated research nurses in the consent process can increase recruitment to emergency care research. Experience of recruiting to clinical trials in nonemergency settings does not seem to help when recruiting for trials in emergency care. Relevance to clinical practice There is a need for greater understanding of the experiences of dedicated research nurses in emergency care settings and in particular with regard to deferred consent.

Stakeholder perspectives on barriers and enablers to recruiting anxious children undergoing day surgery under general anaesthetic: a qualitative internal pilot study of the MAGIC randomised controlled trial

“…In MAGIC, the trial population was anxious children, and clinicians and researchers needed to approach their parents at a difficult time. Although the desire not to add to a family's stress is understandable, paternalism can lead to parents being denied the opportunity to make an informed decision about participation for themselves [18]. The process of recruitment requires various tasks, including connecting and engaging gatekeepers in the RCT in order to establish a shared goal [17].…”

“…The importance of having experience in a specific setting has previously been identified in relation to recruitment in emergency care [18] and lack of experience on surgical day units is a potential barrier. However, stakeholders in MAGIC were able to draw on wider experience and skills to adapt to working in a different way.…”

“…RCTs take place in a range of primary and secondary care settings and may involve a variety of patient populations. Each setting and population poses its own challenges, and a lack of experience specific to that population can be a barrier to recruitment [18]. Parental and health professional concerns about protecting children, due to their vulnerability, can make paediatric trials a particular challenge [19,20].…”

Pregabalin vs placebo to prevent chronic pain after whiplash injury in at-risk individuals: results of a feasibility study for a large randomised controlled trial

“…Nurse researchers with and without clinical roles can improve recruitment to ED trials. 7 We involved mainly nursing and university research staff and less frequently physiotherapists, who's clinical background facilitated discussion with potential participants. In Australia, physiotherapists in EDs are commonplace, 54 and we would aim to increase their involvement in a future trial.…”