Methodological challenges in using routinely collected health data to investigate long-term effects of medication use during pregnancy

Abstract

Abstract:To date, the investigation of teratogenic effects of medications has largely focused on physical alterations present at birth (i.e. malformations) as opposed to functional alterations (i.e. neurodevelopment, metabolic function) that may not be apparent at birth but could influence an individual's health and risk of disease in later life. The use of routinely collected health data represents one approach to better identifying, quantifying, and understanding the long-term risks or benefits of medication use during pregnancy. As such, the objective of this review was to identify and explore opportunities and challenges associated with using routinely collected health data to examine long-term effects of medication use during pregnancy. Drawing on published research several key methodological issues associated with their use in investigating long-term outcomes are reviewed. While significant opportunities exist to make greater use of routinely collected health data, there are a number of key challenges. Identified challenges relate to aspects of study design and analysis, and include obtaining access to data, the ability to match records across datasets and over long periods of time, how medication exposures are ascertained and classified, issues around loss to follow-up how outcomes are ascertained and classified, and the careful interpretation of results in light of study and data limitations. Understanding key challenges associated with using routinely collected health data to investigate long-term effects of medication use during pregnancy is essential in supporting their appropriate use and interpretation, which will contribute to improving the quality of research undertaken and ensure the reliability of results obtained.

Comparison of electronic self‐reported prescription medication use during pregnancy with the national prescription register in Denmark

“…3 Routinely collected electronic healthcare records (EHR) or prescription registers (PR) are often used 3 as this makes identification of large cohorts possible. 4 They also provide a readily available resource to estimate medicine exposure, with the advantages of being prospectively collected, eliminating recall bias. 4,5 However, these sources may overestimate drug exposure, due to nonadherence, and underestimate it if medicines prescribed or purchased prior to conception are taken during pregnancy.…”

“…4 They also provide a readily available resource to estimate medicine exposure, with the advantages of being prospectively collected, eliminating recall bias. 4,5 However, these sources may overestimate drug exposure, due to nonadherence, and underestimate it if medicines prescribed or purchased prior to conception are taken during pregnancy. Exposure during the first trimester is particularly important because of the critical period of organogenesis but is often missed because women do not come to the attention of Health Care Professionals (HCPs) until the end of this period.…”

Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers in Terms of Major Cardiovascular Disease Outcomes in Elderly Patients

“…Failure to adhere to drug regimens may lead to misclassification bias because subjects who were classified as exposed but were in fact not exposed. 37 …”

A qualitative inquiry into implementing an electronic health record system (SmartCare) for prevention of mother-to-child transmission data in Zambia: a retrospective study

“…Routinely collected clinical data can provide much needed information on the prevalence of HIV among pregnant women and the uptake of services for prevention of mother-to-child transmission (PMTCT) of HIV 1. The use of routinely collected data can be timely and cost-efficient for decision-making as data are already available for analysis 2. Collection of high-quality routine data on these services and outcomes for HIV-positive mothers and HIV-exposed infants is essential for monitoring and evaluation of PMTCT programme, for clinical management of patients and for managing stocks of HIV test kits and drugs 1.…”