title: Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.
abstract: The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs.
authors.affiliation: Sheffield Clinical Trials Research Unit, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S14DA, United Kingdom. Electronic address: c.l.cooper@sheffield.ac.uk.
authors.forename: Cindy
authors.initials: C
authors.lastname: Cooper
authors.affiliation: Medical Care Research Unit, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S14DA, United Kingdom. Electronic address: a.ocathain@sheffield.ac.uk.
authors.forename: Alicia
authors.initials: A
authors.lastname: O'Cathain
authors.affiliation: Sheffield Clinical Trials Research Unit, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S14DA, United Kingdom. Electronic address: D.Hind@sheffield.ac.uk.
authors.forename: Danny
authors.initials: D
authors.lastname: Hind
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York YO10 5DD, United Kingdom. Electronic address: joy.adamson@york.ac.uk.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Medical School, Teviot Place, Edinburgh EH8 9AG United Kingdom. Electronic address: j.lawton@ed.ac.uk.
authors.forename: Julia
authors.initials: J
authors.lastname: Lawton
authors.affiliation: Design, Trials and Statistics, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S14DA, United Kingdom. Electronic address: w.o.baird@sheffield.ac.uk.
authors.forename: Wendy
authors.initials: W
authors.lastname: Baird
mesh_terms: D015982:Bias; D003219:Confidentiality; D006801:Humans; D018579:Patient Selection; D036301:Qualitative Research; D012107:Research Design / Q000592:standards*; D006113:United Kingdom
keywords: Complex interventions; Qualitative research; Randomised controlled trial; Trial management