The Perspectives Study: From Evidence to Guidance on Patient Recruitment to Clinical Research in Intensive Care Units, 2016-2019

Data collection was conducted across three workstreams. In workstream (WS) 1, 17 ICU clinicians/researchers, and eight patient and public involvement (PPI) contributors with experience of working on ICU studies, took part in semi-structured telephone interviews about the problems and potential solutions in recruitment and consent to ICU studies. This informed the development of the survey for WS2. In WS2, 1453 participants from 14 ICUs in England took part in the survey, which explored experiences and views of ICU research recruitment and consent process. Forty-four surveys were either duplicates or had substantial missing data so 1409 surveys were included in the analysis. Of these, 333 surveys were from ICU patients, 488 from family members (of whom 63 were bereaved) and 588 were from healthcare practitioners. Thirty five percent (115/333) of patient surveys and 32% (157/488) of family member surveys were from individuals who reported having been approached about research in the ICU, while 44% (260/588) of healthcare practitioner surveys were from those who indicated they had a role in research. For WS3, a purposive sample of 60 participants, 54 of whom had completed the WS2 survey, took part in semi-structured interviews to explore their survey responses and their wider perspectives on ICU research in more depth. This included 13 patients, 30 family members (of whom 4 were bereaved before completing the survey, and 5 were bereaved since they or another family member completed the survey), and 17 healthcare practitioners. Of interviewed patients and family members, 25 had been approached about a study while in the ICU. Of healthcare practitioners, 12 had research roles at the time of their interview (3 doctors, 7 research nurses and 2 pharmacists). The six additional interviewees comprised: four family members of surveyed patients where the family member had visited the patient’s during their ICU stay; two ICU patients whose family members had completed a survey. Although these six interviewees had not completed the WS2 survey, the protocol permitted interviews with such individuals if they had close ties to WS2 participants.