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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
  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. 1Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
  2. 2School of Geography, Politics and Sociology, Newcastle University, Newcastle upon Tyne, UK
  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{at}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

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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.

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