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Linking Centers for Medicare & Medicaid Services data with prospective DCOR trial data: methods and data comparison
Wendy L St Peter1, Jiannong Liu, Eric D Weinhandl
1The College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA. wstpeter@cdrg.org
Hemodialysis International. International Symposium on Home Hemodialysis
|December 19, 2008
Summary
Linking hemodialysis patients to the Centers for Medicare & Medicaid Services End-Stage Renal Disease database improved outcome evaluation. This enhanced data collection identified more deaths and hospitalizations, proving cost-effective for secondary endpoints.
Area of Science:
- Nephrology
- Clinical Trials
- Health Informatics
Background:
- The Dialysis Clinical Outcomes Revisited (DCOR) trial compared sevelamer and calcium-based binders in hemodialysis patients.
- Accurate outcome assessment is crucial for evaluating interventions in chronic kidney disease.
- Traditional prospective data collection can be resource-intensive.
Purpose of the Study:
- To evaluate the effectiveness of linking hemodialysis patients to the Centers for Medicare & Medicaid Services End-Stage Renal Disease (CMS ESRD) database.
- To enhance outcome evaluation, including mortality and hospitalization, in the DCOR trial.
- To assess the cost-effectiveness of using the CMS ESRD database for secondary endpoints.
Main Methods:
- The DCOR trial prospectively collected data and linked participants to the CMS ESRD database using patient identifiers.
- Baseline characteristics and outcome data (mortality, hospitalization) were obtained from both prospective collection and the CMS ESRD database.
- Data from the CMS ESRD database were compared with data collected via case-report forms (CRFs).
Main Results:
- 2101 out of 2103 (99.9%) DCOR participants were successfully linked to the CMS ESRD database.
- The CMS ESRD database identified more deaths and hospitalizations compared to CRF data, with additional deaths verified.
- Linking to the CMS ESRD database provided valuable baseline data and identified more events at a lower cost than prospective collection alone.
Conclusions:
- Linking clinical trial participants to the CMS ESRD database is a feasible and effective method for enhancing outcome assessment.
- The CMS ESRD database serves as a valuable resource for identifying mortality and hospitalization endpoints in hemodialysis patients.
- This approach offers a cost-effective strategy for collecting comprehensive data on secondary endpoints in clinical trials.
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