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, M. J., Thomson, R.G., May, C.R., Rapley, T., Heaven, B.R., Graham, R.H., Kaner, E.F., Stobbart, L. and Eccles, M.P. (2007) 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. Quality and Safety in Health Care, 16, (3), 224-229. (doi:10.1136/qshc.2006.018499).

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Description/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

Item Type: Article
ISSNs: 1475-3898 (print)
1470-7934 (electronic)
Subjects: R Medicine > R Medicine (General)
Divisions: University Structure - Pre August 2011 > School of Health Sciences
Item ID: 163565
Date Deposited: 09 Sep 2010 11:05
Last Modified: 02 Mar 2012 13:59
Contributors: Murtagh, M. J. (Author)
Thomson, R.G. (Author)
May, C.R. (Author)
Rapley, T. (Author)
Heaven, B.R. (Author)
Graham, R.H. (Author)
Kaner, E.F. (Author)
Stobbart, L. (Author)
Eccles, M.P. (Author)
Date: 2007
Status: Published
URI: http://eprints.soton.ac.uk/id/eprint/163565

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