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

Murtagh, M. J., Thomson, R.G., May, C.R., Rapley, T., Heaven, B.R., Graham, R.H., Kaner, E.F., Stobbart, L. and Eccles, M.P. (2007) 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. Quality and Safety in Health Care, 16 (3), 224-229. (doi:10.1136/qshc.2006.018499).

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

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Contributors

Author: C.R. May

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