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.
- AF, atrial fibrillation
- DARTSII, Decision Analysis in Routine Treatment Study II
- RCT, randomised controlled trial
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Funding: This work was supported by Wellcome Trust Health Services Research Project Grants.
Competing interests: None.
The study was approved by the relevant local research ethics committees (Gateshead, South Tyneside, Northumberland and Newcastle/North Tyneside).
MM is the guarantor for this paper.