You are here

  • Home
  • Archive
  • Volume 16, Issue 3
  • 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

Article Text

Article menu
Download PDFPDF
Developing research and practice
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
  1. M J Murtagh1,
  2. R G Thomson1,
  3. C R May1,
  4. T Rapley1,
  5. B R Heaven1,
  6. R H Graham2,
  7. E F Kaner1,
  8. L Stobbart1,
  9. M P Eccles1
  1. Correspondence to:
 Dr M J Murtagh
 Institute of Health and Society, Newcastle University, Framlington Place, Newcastle upon Tyne NE2 4HH, UK; m.j.murtagh@newcastle.ac.uk

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.

  • AF, atrial fibrillation
  • DARTSII, Decision Analysis in Routine Treatment Study II
  • RCT, randomised controlled trial

https://doi.org/10.1136/qshc.2006.018499

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    Request permissions
    View Full Text

    Footnotes

    • 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.