title: 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.
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.
  
  
  METHODS
  Qualitative process evaluation carried out alongside the trial: non-participant observation and semistructured interviews.
  
  
  METHODS
  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.
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. m.j.murtagh@newcastle.ac.uk
authors.forename: M J
authors.initials: MJ
authors.lastname: Murtagh
authors.forename: R G
authors.initials: RG
authors.lastname: Thomson
authors.forename: C R
authors.initials: CR
authors.lastname: May
authors.forename: T
authors.initials: T
authors.lastname: Rapley
authors.forename: B R
authors.initials: BR
authors.lastname: Heaven
authors.forename: R H
authors.initials: RH
authors.lastname: Graham
authors.forename: E F
authors.initials: EF
authors.lastname: Kaner
authors.forename: L
authors.initials: L
authors.lastname: Stobbart
authors.forename: M P
authors.initials: MP
authors.lastname: Eccles
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D026661:Clinical Trials Data Monitoring Committees; D032882:Comprehension; D003657:Decision Making; D003658:Decision Making, Computer-Assisted; D020000:Decision Support Systems, Clinical; D005260:Female; D005715:Gambling; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000379:methods* / Q000523:psychology; D010817:Physician-Patient Relations; D036301:Qualitative Research; D018570:Risk Assessment / Q000379:methods*; D014741:Video Recording
chemical_list: D000925:Anticoagulants