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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

Lookup NU author(s): Professor Madeleine Murtagh, Emeritus Professor Richard Thomson, Professor Carl May, Dr Tim Rapley, Dr Ben Heaven, Dr Ruth Graham, Professor Eileen KanerORCiD, Dr Lynne Stobbart, Penny Eccles



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 sernistructured 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.

Publication metadata

Author(s): Murtagh MJ, Thomson RG, May CR, Rapley TJ, Heaven BRJ, Graham RH, Kaner EFS, Stobbart L, Eccles PJ

Publication type: Article

Publication status: Published

Journal: Quality and Safety in Health Care

Year: 2007

Volume: 16

Issue: 3

Pages: 224-229

Date deposited: 23/02/2010

ISSN (print): 1475-3898

ISSN (electronic): 1475-3901


DOI: 10.1136/qshc.2006.018499


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