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Overall and cause-specific mortality in the Sentinel system: A power analysis
Richard S Swain1, Lockwood G Taylor1, Tiffany S Woodworth2
1Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland, USA.
Pharmacoepidemiology and Drug Safety
|November 14, 2018
Summary
Sentinel death data is sufficient for all-cause mortality safety studies and potentially for cause-specific outcomes. Further data quality assessment is recommended for comprehensive medical product safety evaluations.
Area of Science:
- Pharmacovigilance
- Epidemiology
- Health Data Analytics
Background:
- The Sentinel System is a key resource for post-licensure medical product safety surveillance.
- Characterizing mortality data within Sentinel is crucial for understanding its utility in safety studies.
- Previous assessments of Sentinel's mortality data completeness and suitability for research are limited.
Purpose of the Study:
- To evaluate the adequacy of Sentinel's mortality data for powering post-marketing safety studies.
- To determine if Sentinel contains sufficient all-cause and cause-specific mortality events for robust safety signal detection.
- To inform the optimal use of Sentinel's mortality data in medical product safety research.
Main Methods:
- Calculated crude rates of all-cause mortality and suicide, and proportional mortality from suicide (2004-2012) across seven Sentinel data partners.
- Stratified mortality rates by data partner, sex, age group, and calendar year.
- Compared Sentinel data with national estimates from CDC WONDER and performed sample size estimations for various mortality outcomes.
Main Results:
- Observed 479,694 deaths (5,811 suicides) over 68 million person-years.
- Pooled death and suicide rates in Sentinel were 710 and 8.6 per 100,000 person-years, respectively, compared to national rates.
- Sentinel data reflected national trends of decreasing overall mortality and increasing proportional suicide mortality; sample size estimations indicated sufficient power for certain safety study scenarios.
Conclusions:
- Sentinel's all-cause mortality data appears well-powered for safety outcome analysis.
- Cause-specific mortality outcomes within Sentinel may be adequately powered under specific circumstances.
- Further investigation into the quality of Sentinel death data is warranted to maximize its research utility.
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