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Overall and cause‐specific mortality in the Sentinel system: A power analysis

Journal Article · · Pharmacoepidemiology and Drug Safety
DOI:https://doi.org/10.1002/pds.4692· OSTI ID:1481931
 [1];  [1];  [2];  [2];  [2];  [2];  [2];  [2];  [1]
  1. Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology Food and Drug Administration Silver Spring Maryland USA
  2. Department of Population Medicine, Harvard Pilgrim Health Care Institute Harvard Medical School Boston Massachusetts USA
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Abstract Purpose

Mortality data within the Sentinel Death Tables remain generally uncharacterized. Assessment of mortality data within Sentinel will help inform its utility for medical product safety studies.

Methods

To determine if Sentinel contains sufficient all‐cause and cause‐specific mortality events to power postmarketing safety studies.

We calculated crude rates of all‐cause mortality and suicide and proportional mortality from suicide from 2004 to 2012 in seven Sentinel data partners. Results were stratified by data partner, sex, age group, and calendar year and compared with national estimates from Centers for Disease Control and Prevention Wide‐ranging ONline Data for Epidemiologic Research. We performed sample size estimations for all‐cause mortality and 10 leading causes of death.

Results

We observed 479 694 deaths, including 5811 suicides, during 68 million person‐years of follow‐up. Pooled mean death and suicide rates in the data partners were 710 and 8.6 per 100 000 person‐years, respectively (vs 810 and 11.8 nationally). The mean proportional mortality from suicide among the data partners was 1.2%, compared with 1.5% nationally. National trends of decreasing overall mortality and increasing proportional mortality for suicide were reflected within Sentinel. We estimated that detecting hazard ratios of 1.25 and 3 would require 16 442 and 460 exposed patients, respectively, for overall mortality, and 1.3 million and 37 411, respectively, for suicide.

Conclusions

This was the first study to investigate mortality data in the Sentinel death tables. We found that all‐cause mortality appeared well powered for use as a safety outcome and cause‐specific mortality outcomes may be adequately powered in certain circumstances. Further investigation into the quality of the Sentinel death data is needed.

Sponsoring Organization:
USDOE
OSTI ID:
1481931
Journal Information:
Pharmacoepidemiology and Drug Safety, Journal Name: Pharmacoepidemiology and Drug Safety Journal Issue: 12 Vol. 27; ISSN 1053-8569
Publisher:
Wiley Blackwell (John Wiley & Sons)Copyright Statement
Country of Publication:
Country unknown/Code not available
Language:
English

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