Qualitative research in evidence-based medicine: improving decision-making and participation in randomized controlled trials of cancer treatments.

BACKGROUND: Since the 1990s there has been increasing emphasis on 'evidence-based medicine'. The randomized controlled trial is widely regarded as the 'gold-standard' study design for evaluating interventions. However, placing too strong an emphasis on a phase III trial, to the neglect of earlier development and piloting work, may result in weaker interventions that are more difficult to evaluate and less likely to be implemented. AIM: To illustrate the benefits and outcomes of qualitative research at the early stages of the research continuum. SETTING/PARTICIPANTS: Two cancer studies are evaluated in which the best treatment option is uncertain: ASPECTS (A Study of Patients ExperienCes of TreatmentS) and ProtecT (Prostate Testing for Cancer and Treatment).
DESIGN: To examine decision-making in relation to palliative chemotherapy for advanced cancer, ASPECTS was a qualitative study involving non-participant observation and recording of oncology consultations. During the ProtecT feasibility study, recruitment interviews were routinely audiotaped and in-depth interviews conducted with men to explore their understanding of treatment options and randomization to trial arms.
RESULTS: ASPECTS identified that insufficient information was given to patients about the survival benefits of palliative chemotherapy with implications for informed consent. ProtecT illustrated the effective use of qualitative research methods to resolve recruitment and randomization problems for a randomized controlled trial.
CONCLUSIONS: These studies illustrate the value of qualitative research, particularly during the earlier phases of the research continuum. Such research may generate hypotheses, strengthen the development and implementation of interventions and enhance their evaluation: all of which are essential to evidence-based medicine.

RCT Entities:   Population Interventions Outcomes