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 Murtagh1,
- R G Thomson1,
- C R May1,
- T Rapley1,
- B R Heaven1,
- R H Graham2,
- E F Kaner1,
- L Stobbart1,
- M P Eccles1
- 1Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
- 2School of Geography, Politics and Sociology, Newcastle University, Newcastle upon Tyne, UK
- Correspondence to: Dr M J Murtagh Institute of Health and Society, Newcastle University, Framlington Place, Newcastle upon Tyne NE2 4HH, UK;
- Accepted 5 March 2007
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
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.