title: Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers.
abstract: Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.
authors.affiliation: Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Street, Sheffield, S1 4DA UK.
authors.forename: Alicia
authors.initials: A
authors.lastname: O'Cathain
authors.affiliation: Primary Care, Nursing Midwifery and Allied Health Professionals Research Unit, University of Stirling, Stirling, FK9 4LA Scotland UK.
authors.forename: Pat
authors.initials: P
authors.lastname: Hoddinott
authors.affiliation: Global Health Unit, Norwegian Knowledge Centre for the Health Services, Oslo, Norway ; Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa.
authors.forename: Simon
authors.initials: S
authors.lastname: Lewin
authors.affiliation: Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Street, Sheffield, S1 4DA UK.
authors.forename: Kate J
authors.initials: KJ
authors.lastname: Thomas
authors.affiliation: Institute of Psychology, Health and Society, University of Liverpool, Waterhouse Building, Block B, Brownlow Street, Liverpool, L69 3GL UK.
authors.forename: Bridget
authors.initials: B
authors.lastname: Young
authors.affiliation: Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD UK.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.affiliation: Behavioural and Societal Sciences, Work, Health & Care, Schoemakerstraat 97 (Gebouw A), Delft, 2628 VK Netherlands.
authors.forename: Yvonne Jfm
authors.initials: YJ
authors.lastname: Jansen
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Mills
authors.affiliation: Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement, Cardiff University, Cardiff, CF10 3XQ UK.
authors.forename: Graham
authors.initials: G
authors.lastname: Moore
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Donovan
keywords: Feasibility studies; Guidance; Pilot studies; Qualitative methods; Randomised controlled trial