Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2007 Jun;16(3):224-9.
doi: 10.1136/qshc.2006.018499.

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 Murtagh  1 , R G Thomson, C R May, T Rapley, B R Heaven, R H Graham, E F Kaner, L Stobbart, M P Eccles
Affiliations
Randomized Controlled Trial

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 Murtagh et al. Qual Saf Health Care. 2007 Jun.

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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None.

References

    1. Campbell M, Fitzpatrick A, Kinmonth A L.et al Framework for design and evalution of complex interventions to improve health. BMJ 2000321694–696. - PMC - PubMed
    1. Bradley F, Wiles R, Kinmonth A L.et al Development and evaluation of complex interventions in health services research: case study of Southampton Health Integrated Care Project (SHIP). BMJ 1999318711–715. - PMC - PubMed
    1. Medical Research Council A framework for development and evaluation of RCTs for complex interventions to improve health. London: Medical Research Council, 2000
    1. Welton A, Hepworth J, Collins N.et al Decision‐making about hormone replacement therapy by women in England and Scotland. Climacteric 2004741–49. - PubMed
    1. Thomson R, Robinson A, Greenaway J.et al Development and description of a decision analysis based decision support tool for stroke prevention in atrial fibrillation. Qual Saf Health Care 20021125–31. - PMC - PubMed

Publication types

MeSH terms