Transparency in real-world evidence (RWE) studies to build confidence for decision-making: Reporting RWE research in diabetes.

Abstract

Transparency of real-world evidence (RWE) studies is critical to understanding how findings of a specific study were derived and is a necessary foundation to assessing validity and determination of whether decisions should be informed by the findings. In the present paper, we lay out strategies to improve clarity in the reporting of comparative effectiveness studies using real-world data that were generated by the routine operation of a healthcare system. This may include claims data, electronic health records, wearable devices, patient-reported outcomes or patient registries. These recommendations were discussed with multiple stakeholders, including regulators, payers, academics and journal editors, and endorsed by two professional societies that focus on RWE. We remind readers interested in diabetes research of the utility of conceptualizing a target trial that is then emulated by a RWE study when planning and communicating about RWE study implementation. We recommend the use of a graphical representation showcasing temporality of key longitudinal study design choices. We highlight study elements that should be reported to provide the clarity necessary to make a study reproducible. Finally, we suggest registering study protocols to increase process transparency. With these tools the readership of diabetes RWE studies will be able to more efficiently understand each study and be more able to assess a study's validity with reasonably high confidence before making decisions based on its findings.