A systematic review of pregnancy exposure registries: examination of protocol-specified pregnancy outcomes, target sample size, and comparator selection
Pharmacoepidemiology and Drug Safety2016Vol. 26(2), pp. 208–214
Citations Over TimeTop 10% of 2016 papers
Kate Gelperin, Hoda T. Hammad, Kira Leishear, Steven T. Bird, Lockwood G. Taylor, Christian Hampp, Leyla Şahin
Abstract
No registries were designed to have sufficient power to assess specific malformations, despite the plausibility that most teratogens cause specific defects. Only half of the registries included a power analysis. Despite their common use, external comparators, including MACDP, have important limitations. In the absence of randomized controlled trial data in pregnant women, pregnancy registries remain an important tool as part of a comprehensive pregnancy surveillance program; however, pregnancy registries alone may not be sufficient to obtain adequate data regarding risks of specific malformations. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
Related Papers
- → Sample Size and its Importance in Research(2020)382 cited
- → The Relationship between components of sample size Estimate and Sample Size(2022)3 cited
- → Sample size calculation(2023)3 cited
- → Sample Size Planning(2010)14 cited
- → People believe data from a sample of 30 nearly as much as data from a sample of 3000(2018)