Abstract

AbstractReal-world data have become increasingly important in medical science and healthcare. A new, effective, and practically feasible statistical design is needed to unlock the potential of real-world data that decision-makers and practitioners can use to meet people’s healthcare needs. In the first half of the study, we validated our proposed new method by simulation, and in the second half, we conducted a clinical study on actual real-world data. We proposed the “Exact Matching Algorithm Using Administrative Health Claims Database Equivalence Factors (AHCDEFs)” using a target trial emulation framework. The simulation trials were conducted 500 times independently, considering the misclassification and chance errors of all variables and competing events of outcome. Two conventional methods, multivariate and propensity score analyses, were compared. Next, we estimated the effect of specific health guidance provided in Japan on the prevention of diabetes onset and medical expenditures. Our proposed novel method for real-world data returns improved estimates and fewer type I errors (the probability of erroneously determining that there is a difference when, in fact, there is no difference) than conventional methods. We quantitatively demonstrated the effectiveness of specific health guidance in Japan in preventing the onset of diabetes and reducing medical expenditures during five years. We proposed a new method for analyzing real-world data and an exact-matching algorithm using AHCDEFs. The larger the number of patients available for analysis, the more the AHCDEFs that can be matched, thereby removing the influence of confounding factors. This method will generate significant evidence when applied to real-world data.

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