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Case-only designs in pharmacoepidemiology: a systematic review
Sandra Nordmann1, Lucie Biard, Philippe Ravaud
1Univ Paris Diderot, Sorbonne Paris Cité, UMR-S 738; INSERM, UMR-S 738, Paris, France.
Plos One
|November 21, 2012
Summary
Pharmacoepidemiology studies using case-crossover (CC) and self-controlled case series (SCCS) designs require more rigorous application of validity assumptions and improved results reporting for better implementation.
Area of Science:
- Pharmacoepidemiology
- Biostatistics
- Drug Safety Research
Background:
- Case-only study designs, including case-crossover (CC) and self-controlled case series (SCCS), have been utilized since the late 1980s.
- These designs offer advantages by using only cases and being self-controlled, thus mitigating selection bias and confounding.
- They control for time-invariant characteristics inherent to subjects.
Purpose of the Study:
- To systematically review the application and reporting of CC and SCCS designs in pharmacoepidemiology literature.
- To assess the fulfillment of applicability assumptions for these case-only designs.
- To evaluate the reporting of specificities related to case-only analyses.
Main Methods:
- A systematic literature search was conducted in MEDLINE and EMBASE up to September 15, 2010.
- Data extraction from selected reports was performed using a standardized form.
- Analysis included 93 reports, categorizing them by CC, SCCS, or combined designs.
Main Results:
- Out of 93 reports, 50 (54%) used CC and 45 (48%) used SCCS; 2 reports employed both designs.
- Validity assumptions were met in 24% of CC and 40% of SCCS articles.
- Results reporting adequately addressed case-only specificities in 54% of articles (30% CC, 78% SCCS).
Conclusions:
- The implementation of CC and SCCS designs in pharmacoepidemiology needs enhancement.
- Greater rigor is required in applying the validity assumptions of these case-only designs.
- Improvement in the reporting of results from CC and SCCS studies is necessary.
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