Quality & safety in health care · 2007
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.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Murtagh M J, Thomson R G, May C R, Rapley T, Heaven B R, Graham R H, Kaner E F, Stobbart L, Eccles M P
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAnticoagulantsAtrial FibrillationClinical Trials Data Monitoring CommitteesComprehensionDecision MakingDecision Making, Computer-AssistedDecision Support Systems, ClinicalFemaleGamblingHumansInterviews as TopicMaleMiddle AgedPatient ParticipationPhysician-Patient RelationsQualitative ResearchRisk AssessmentVideo Recording