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Patient expectations in placebo-controlled randomized clinical trials
David A Stone1, Catherine E Kerr, Eric Jacobson
1South-East European Research Centre, City College, Greece.
Journal of Evaluation in Clinical Practice
|January 22, 2005
Summary
Patient expectations in clinical trials are dynamic, influenced by various factors before and during the study. Understanding these evolving expectations is crucial for interpreting placebo responses in randomized clinical trials.
Area of Science:
- Clinical Research
- Psychology of Health
- Patient Experience
Background:
- Limited understanding of how patient expectations form in clinical trials.
- Previous research focused on consent and randomization, not expectation development.
Purpose of the Study:
- To explore patient experiences in placebo-controlled randomized clinical trials (RCTs).
- To investigate the formation and evolution of participant expectations during RCTs.
Main Methods:
- Qualitative study utilizing in-depth interviews with nine patients across four RCTs.
- Semi-structured interview guide and a codebook format for data analysis.
- Comparison of narratives on expectation, blinding, and placebo to identify themes.
Main Results:
- Patient expectations are shaped by multiple factors before and during trials.
- Influencing factors include prior trial/treatment experiences, medication status, and health professional input.
- Side effects and trial measurements also significantly impact patient expectations.
Conclusions:
- Participant expectations in RCTs are not static but continuously evolve.
- The fluid nature of expectations may explain variability in placebo response.
- Equalizing expectations in RCTs presents a significant challenge.