PT - JOURNAL ARTICLE 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 TI - 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 AID - 10.1136/qshc.2006.018499 DP - 2007 Jun 01 TA - Quality and Safety in Health Care PG - 224--229 VI - 16 IP - 3 4099 - http://qualitysafety.bmj.com/content/16/3/224.short 4100 - http://qualitysafety.bmj.com/content/16/3/224.full SO - Qual Saf Health Care2007 Jun 01; 16 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.