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How do doctors explain randomised clinical trials to their patients?
V A Jenkins1, L J Fallowfield, A Souhami
1Department of Oncology, University College Medical School, Bland Sutton Institute, London, U.K. v.a.jenkins@ucl.ac.uk
European Journal of Cancer (Oxford, England : 1990)
|January 1, 2000
Summary
Doctors often express uncertainty when discussing randomized clinical trials (RCTs) with patients. UK clinicians use varied approaches for informed consent, highlighting communication diversity in clinical research.
Area of Science:
- Medical Communication
- Clinical Trial Ethics
- Oncology Research
Background:
- Effective doctor-patient communication is crucial for informed consent in clinical trials.
- Understanding current practices in obtaining consent for randomized clinical trials (RCTs) is essential for improvement.
- Previous research indicates variability in how clinicians present trial information.
Purpose of the Study:
- To analyze doctor-patient communication during the consent process for randomized clinical trials (RCTs).
- To identify common communication strategies and challenges faced by clinicians in oncology settings.
- To evaluate the clarity and completeness of information provided to patients regarding RCTs.
Main Methods:
- Audio-recording 82 doctor-patient discussions for RCT consent.
- Conducted by 5 clinical oncologists in UK District General and University Hospitals.
- Qualitative analysis of communication patterns, including expression of uncertainty and explanation of randomization.
Main Results:
- Clinicians expressed uncertainty about treatment decisions in 96.3% of cases.
- The term 'randomization' was used in 62.2% of consultations, often implicitly (95.1%).
- Information leaflets were not provided to 28% of patients, despite frequent discussion of treatments and side effects.
Conclusions:
- UK clinicians employ diverse, individualized methods for informing patients and obtaining consent for RCTs.
- Expressing uncertainty can foster trust, but clear explanation of randomization and provision of written materials are key.
- Improving doctor-patient communication in RCT consent requires standardized yet flexible approaches.