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Katharina Meiszl

Publications and source records attributed to Katharina Meiszl.

2 recordsLinked to original sources

The Symmetric Pair Matching Design: A Self-Controlled Method with Automatic Adjustment for Time Effects

Self-controlled study designs eliminate confounding by individual-level characteristics that remain constant during the observation time and are thus widely used in pharmacoepidemiology and vaccine safety research. However, existing methods remain vulnerable to time effects, including temporal trends and seasonality in the exposure or outcome, unless these are explicitly modeled or controlled through the study design. We introduce the symmetric pair matching design (SPM), a novel self-controlled method that combines design-based adjustment for time effects with automatic control of time-invariant confounding. Unlike previous design-based approaches that account for time effects, SPM uses observation time both before and after event occurrence, thereby retaining a larger proportion of the available information. We derive the theoretical properties of the method and evaluate its finite-sample performance through simulations. In the simulations, SPM produced unbiased estimates in the presence of temporal trends in both the outcome and exposure, while maintaining greater or comparable statistical efficiency than existing approaches. SPM extends the family of self-controlled methods by providing design-based control of time effects without requiring explicit modeling thereof. By combining robustness to temporal confounding with efficient use of observation time, SPM offers a practical alternative for observational studies with transient exposures. An accompanying R package is provided to facilitate its usage in applied research.

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Impact of Record-Linkage Errors in Covid-19 Vaccine-Safety Analyses using German Health-Care Data: A Simulation Study

With unprecedented speed, 192,248,678 doses of Covid-19 vaccines were administered in Germany by July 11, 2023 to combat the pandemic. Limitations of clinical trials imply that the safety profile of these vaccines is not fully known before marketing. However, routine health-care data can help address these issues. Despite the high proportion of insured people, the analysis of vaccination-related data is challenging in Germany. Generally, the Covid-19 vaccination status and other health-care data are stored in separate databases, without persistent and database-independent person identifiers. Error-prone record-linkage techniques must be used to merge these databases. Our aim was to quantify the impact of record-linkage errors on the power and bias of different analysis methods designed to assess Covid-19 vaccine safety when using German health-care data with a Monte-Carlo simulation study. We used a discrete-time simulation and empirical data to generate realistic data with varying amounts of record-linkage errors. Afterwards, we analysed this data using a Cox model and the self-controlled case series (SCCS) method. Realistic proportions of random linkage errors only had little effect on the power of either method. The SCCS method produced unbiased results even with a high percentage of linkage errors, while the Cox model underestimated the true effect.

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