RT Journal Article
SR Electronic
T1 Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool
JF Quality and Safety in Health Care
JO Qual Saf Health Care
FD BMJ Publishing Group Ltd
SP 224
OP 229
DO 10.1136/qshc.2006.018499
VO 16
IS 3
A1 Murtagh, M J
A1 Thomson, R G
A1 May, C R
A1 Rapley, T
A1 Heaven, B R
A1 Graham, R H
A1 Kaner, E F
A1 Stobbart, L
A1 Eccles, M P
YR 2007
UL http://qualitysafety.bmj.com/content/16/3/224.abstract
AB Objective: To understand participants’ experiences and understandings of the interventions in the trial of a computerised decision support tool in patients with atrial fibrillation being considered for anti-coagulation treatment. Design: Qualitative process evaluation carried out alongside the trial: non-participant observation and semistructured interviews. Participants: 30 participants aged >60 years taking part in the trial of a computerised decision support tool. Results: Qualitative evidence provided the rationale to undertake a decision to discontinue one arm of the trial on the basis that the intervention in that arm, a standard gamble values elicitation exercise was causing confusion and was unlikely to produce valid data on participant values. Conclusions: Qualitative methods used alongside a trial allow an understanding of the process and progress of a trial, and provide evidence to intervene in the trial if necessary, including evidence for the rationale to discontinue an intervention arm of the trial.