OBJECTIVES:

The need for Patient-Reported Outcomes is increasing in clinical trials and observational studies. These patient-centered endpoints quantify medical needs from a patient perspective. These data are adding another real value of a treatment or will describe the burden of disease from a patient perspective. However, few systems enable researchers to collect PRO data directly from specific patients without using identifiable information.

METHODS:

Electronic Medicine Diary was developed to manage data on prescriptions dispensed at pharmacies on a cloud based server using FeliCa, a contactless IC card, used widely as “Suica” for public transportation system in Tokyo Metropolitan Area. Harmo only transmits “prescription history” data to the server and no other data are stored in the cloud. “Identifiable Information” is only stored on the patient’s card. This system enables researchers to collect prescription information without accessing identifiable information. Questionnaires can be sent to subjects using via a website or app. Data can be segmented by the medicine, prescription history, gender and area.

RESULTS:

Three major disease types were chosen as pilot studies; autoimmune disease, metabolic disease and allergic disease for PRO e.g. EQ5D-5L collection. The feasibility shows 23,000 atopic dermatitis patients , 5,000 diabetics patients and 12,000 allergy patients with the following prescription: topical corticosteroids, basal insulin and antihistamine, respectively.

CONCLUSIONS:

The data shows potential in terms of patients and treatment strata possibility for PRO. Patients inclusion criteria can be performed by medication information. In this example we use the above prescription criteria for patient selection without the need for identifiable information.