TY - JOUR 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 SP - 224 LP - 229 DO - 10.1136/qshc.2006.018499 VL - 16 IS - 3 AU - M J Murtagh AU - R G Thomson AU - C R May AU - T Rapley AU - B R Heaven AU - R H Graham AU - E F Kaner AU - L Stobbart AU - M P Eccles Y1 - 2007/06/01 UR - http://qualitysafety.bmj.com/content/16/3/224.abstract N2 - 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. ER -