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.
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.
Murtagh
M J
MJ
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. m.j.murtagh@newcastle.ac.uk
Thomson
R G
RG
May
C R
CR
Rapley
T
T
Heaven
B R
BR
Graham
R H
RH
Kaner
E F
EF
Stobbart
L
L
Eccles
M P
MP
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
D000925:Anticoagulants