Study Explores Real-World Data Reporting Quality According to RECORD Statement

June 30, 2023

With the rise of real-world data (RWD) and real-world evidence (RWE), a lack of transparency impairs reproducibility and quality assessment. The Reporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement was drafted to help address this issue. A newly published study in BMC Medical Research Methodology explores reporting quality in RWD studies using the RECORD checklist.

According to the authors, “We found that only 72 (38.5%) articles adequately reported more than 50% of the items, and some vital items were very insufficiently reported. The overall reporting quality was poor. Some items were reported similarly to analogous studies, such as the codes and algorithms for population selection and their validation studies, as well as data cleaning (R6.1, R6.2, R12.2), while some items were reported worse than analogous studies, such as the codes and algorithms of exposures, outcomes, confounders, and the availability of supplementary materials (R7.1a, R7.1b, R22.1c). While most studies stated that there were inherent limitations when using RWD, there is insufficient discussion of the limitations in some specific areas. Data cleaning, data linkage, and disclosure of relevant information were also severely underreported.”

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(Source: BMC Medical Research Methodology, June 29th, 2023)

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