Related Experiment Videos
How can we design trials to detect clinically important changes in disease severity?
D M Chaput de Saintonge1, J R Kirwan, S J Evans
1Department of Clinical Pharmacology and Therapeutics, London Hospital Medical College.
British Journal of Clinical Pharmacology
|October 1, 1988
Summary
Rheumatologists showed significant disagreement when assessing patient disease activity changes. Modeling their clinical judgment revealed varied variable weighting, highlighting the need for consensus in clinical trial outcomes.
Area of Science:
- Rheumatology
- Clinical Epidemiology
- Health Outcomes Research
Background:
- Assessing changes in disease activity is crucial in rheumatology.
- Variability in clinical judgment can impact trial outcomes and patient care.
- Standardized methods for evaluating clinical importance are needed.
Purpose of the Study:
- To model rheumatologists' clinical judgment policies for disease activity change.
- To identify factors contributing to disagreement in assessing clinical importance.
- To explore methods for establishing consensus on successful trial outcomes.
Main Methods:
- Utilized patient data with 10 clinical variables recorded a year apart.
- Employed linear regression to model clinical judgment based on visual analogue scale (VAS) scores.
- Analyzed the weights attributed to each clinical variable by individual rheumatologists.
Main Results:
- Significant inter-physician variability was observed in judging patient improvement or deterioration.
- Weights assigned to clinical variables differed considerably among rheumatologists.
- Discrepancies existed between perceived and actual variable weighting in judgment models.
Conclusions:
- Clinical judgment in rheumatology is subjective and lacks consistent agreement.
- Modeling individual judgment policies can reveal sources of disagreement.
- Developing consensus-based outcome measures can enhance clinical trial power and relevance.