Medical Chart Reviews as a Method for Real-World Data Generation: Objectives, Processes, and Challenges
Medical chart reviews (MCRs) play a vital role in healthcare research. In practice, however, if there is a research question around healthcare data, MCRs are typically not the first option. Instead, researchers typically prefer the use of existing databases – for reasons of easiness of data access, large available patient numbers, and lower cost. If medical data are needed, Electronic Medical Records (EMR) databases are the preferred option. Such EMR databases exist in various countries; examples are several EMR databases in the US (for example, OPTUM database) or the CPRD-HES database in the UK. In other cases, claims data might also be an option, depending on the concrete research question; examples are French national, Italian, or German claims data.
However, if such databases do not exist or are hardly accessible, MCRs become an option for generating a medical patient-level database that allows one to answer the respective research question. Two main sources for an MCR can be considered: (1) electronic medical records and (2) handwritten medical records; hybrid MCRs using both source types also exist. These records or charts practically exist in all types of healthcare institutions. Most frequently, MCR studies will either be done in physicians’ practices or hospitals. The main idea of an MCR is, therefore, to extract the electronic and handwritten medical charts based on a pre-defined questionnaire to generate the desired database.
This paper explores the basic processes around an MCR as well as its advantages and disadvantages and provides a couple of recommendations on how an “ideal” MCR should be conducted. Trade-offs researchers should be aware of in designing an MCR will be explored.