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    Qual Saf Health Care. 2007 Jun;16(3):224-9.

    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 MJ, Thomson RG, May CR, Rapley T, Heaven BR, Graham RH, Kaner EF, Stobbart L, Eccles MP.

    Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. m.j.murtagh@newcastle.ac.uk

    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.

    PMID: 17545351 [PubMed - indexed for MEDLINE]

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