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Using an empirical method for establishing clinical outcome targets in disease management programs
Ariel Linden1, John L Adams, Nancy Roberts
1Linden Consulting Group, Portland, Oregon, USA. ariellinden@yahoo.com
Disease Management : DM
|July 2, 2004
Summary
This study introduces a simple method to determine minimum expected improvement for disease management (DM) clinical outcomes. It helps set clinically meaningful targets when subjective judgment is not feasible, aiding in quality improvement assessments.
Area of Science:
- Health Services Research
- Biostatistics
- Clinical Trial Design
Background:
- The disease management (DM) industry faces increasing pressure to demonstrate both clinical quality improvements and cost reductions.
- Setting clinically meaningful targets for patient outcomes is crucial but challenging, especially when subjective medical expertise is limited.
- Statistical significance does not always equate to clinical meaningfulness, highlighting the need for robust effect size determination.
Purpose of the Study:
- To propose a simple empirical method for determining the minimum expected improvement level for clinical outcome measures in disease management.
- To provide practical tools, including graphical displays, for setting appropriate effect sizes in DM studies.
- To address situations where outcome measures are not easily assessed by medical experts.
Main Methods:
- Development of a straightforward empirical approach to calculate minimum expected effect sizes.
- Comparison of two proportions as the primary statistical framework for outcome measures.
- Inclusion of graphical aids to supplement or replace statistical calculations for effect size determination.
Main Results:
- The proposed method offers a systematic way to define minimum clinically relevant differences in DM outcomes.
- Graphical displays facilitate the practical application of effect size determination for researchers and practitioners.
- The method is particularly valuable for quantitative outcome measures lacking clear subjective benchmarks.
Conclusions:
- The empirical method provides a valuable tool for setting realistic and meaningful clinical improvement targets in disease management.
- This approach enhances the rigor of DM program evaluation by standardizing the assessment of effect sizes.
- The study supports evidence-based decision-making in healthcare by improving the definition of clinically significant outcomes.