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

M. J. Murtagh*, R. G. Thomson, C. R. May, T. Rapley, B. R. Heaven, R. H. Graham, E. F. Kaner, L. Stobbart, M. P. Eccles

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

54 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)224-229
Number of pages6
JournalQuality and Safety in Health Care
Volume16
Issue number3
Early online date1 Jun 2007
DOIs
Publication statusPublished - 1 Jun 2007
Externally publishedYes

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