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Cohort maintenance and comparability in a pharmacoepidemiologic study using a commercial consumer panel to recruit
J S Gardner1, C A Szpunar, M J O'Connell
1Department of Pharmacy, University of Washington, Seattle, WA, USA.
Pharmacoepidemiology and Drug Safety
|July 1, 1996
Summary
The Upjohn Consumer Health Survey (UCHS) used a matched comparator group to assess ROGAINE Topical Solution 2% users. While demographically matched, baseline differences impacted results, highlighting the need for careful comparator selection in observational studies.
Area of Science:
- Dermatology
- Pharmacovigilance
- Observational Research
Background:
- The Upjohn Consumer Health Survey (UCHS) investigated the safety of ROGAINE Topical Solution 2% (minoxidil).
- Observational studies require robust comparator groups to minimize bias.
Purpose of the Study:
- To evaluate cause-specific deaths and hospitalizations in ROGAINE Topical Solution 2% users compared to a matched cohort.
- To assess the utility of a commercial consumer panel for selecting demographically matched comparators.
Main Methods:
- Prospective, observational study design.
- Two cohorts: ROGAINE Topical Solution 2% users (N=11,122) and a demographically matched Comparator cohort (N=11,173) from a consumer panel.
- Data collection via participant interviews and medical event confirmation over 12 months.
Main Results:
- High follow-up rates (≥94%) achieved in both cohorts.
- Successful demographic matching of cohorts, but significant differences in baseline chronic conditions and risk factors were noted.
- These baseline differences could influence study endpoints.
Conclusions:
- Commercial consumer panels can facilitate rapid selection of demographically matched comparators for observational studies.
- Careful consideration of baseline characteristics beyond demographics is crucial for valid comparisons.
- Multi-stage sampling may be necessary for selecting comparators with specific characteristics.