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

Qual Saf Health Care. 2007 Jun;16(3):224-9. doi: 10.1136/qshc.2006.018499.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use*
  • Atrial Fibrillation / drug therapy*
  • Clinical Trials Data Monitoring Committees
  • Comprehension
  • Decision Making
  • Decision Making, Computer-Assisted*
  • Decision Support Systems, Clinical
  • Female
  • Gambling
  • Humans
  • Interviews as Topic
  • Male
  • Middle Aged
  • Patient Participation / methods*
  • Patient Participation / psychology
  • Physician-Patient Relations*
  • Qualitative Research*
  • Risk Assessment / methods*
  • Video Recording

Substances

  • Anticoagulants