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. Issue 3 (1st June 2007)

• Record Type: Journal Article
• Authors: Murtagh, M J; Thomson, R G; May, C R; Rapley, T; Heaven, B R; Graham, R H; Kaner, E F; Stobbart, L; Eccles, M P
• Is Part Of: Quality & safety in health care. Volume 16:Issue 3(2007)
• Page Start: 224
• Page End: 229
• Publication Date: 2007-06-01
• Subjects: AF, atrial fibrillation -- DARTSII, Decision Analysis in Routine Treatment Study II -- RCT, randomised controlled trial
• DOI: 10.1136/qshc.2006.018499
• Languages: English
• ISSNs: 1475-3898

Abstract

Abstract : 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.