Investigation of diffusion, practical use, and utility of a medical device for Japanese hemophilia patients in a single institution

Abstract

Introduction

Standardized treatments are intended to eliminate bias by each hospital and physician and provide unified and appropriate treatment. Personalized treatments clarify the pathological condition of each patient and provide treatment without any surplus or deficiency based on standardized treatments. In this study, we take the example of hemophilia, one of the rare diseases, and measure diffusion, practical use, and utility of medical devices at the clinical site, the drug cost and clinical outcome, demonstrate its usefulness, and present measures to introduce standardized and individualized treatment. myPKFiT® is a medical device that allows authorized users to simulate dosing regimens with Hemophilia patients' pharmacokinetic profiles of FVIII based on 2 blood samples.

Methods

We interviewed clinical psychologists, nurses, and physicians focusing on “improvement of awareness” and “removal of disability”, collecting clinical data, annualized bleeding rate (ABR), annualized joint bleeding rate (AJBR), and cost of FVIII consumption in Ogikubo Hospital, Hemophilia center.

Results

We specified the original method of Ogikubo Hospital from the results of interview on adopting medical devices. Clinical outcome analysis was performed on patients with medical devices who have transfusion records before and after an operation.

Conclusion

Though personalized treatment can be formalized to some extent, it is expected that medical treatment skills and management by tacit knowledge are affected in individualized treatment based on standardized treatment. Medical institutions and medical staff are the main body sharing and deploying measures to disseminate and utilize medical devices, cooperating with them can be an effective management of standardized and individualized treatment.