| Autor: |
Satoru Mogami, Mikiko Noyes, Rika Morita, Atsuko Shiotsuki, Toshiaki Hagi, Hiroe Hasegawa, Chikara Iida, Mina Izuchi, Fumiharu Naganeo, Junko Tanabe, Kyoko Uno, Osamu Suga, Chikara Kikuchi |
| Předmět: |
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| Zdroj: |
Medical Writing; Dec2017, Vol. 26 Issue 4, p42-45, 4p |
| Abstrakt: |
Prior to this project, no patient lay summary (PLS) had ever been developed locally in Japan. In order to create a PLS that is more tailored to local patients, we attempted to develop one in and for Japanese. Such PLS was drafted based on the disclosed summary of the clinical study report. We took a composite approach in refining the PLS by researching on lay language and patientfriendly designs. At the same time, we ensured scientific accuracy through consultation with experts such as physicians and statisticians, practised diligence on regulatory and legal aspects, and incorporated patient's voice by consulting a local patient advocacy group. We successfully created a PLS in the Japanese language for the first time, which was more patient centric than those translated from another language. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Supplemental Index |
| Externí odkaz: |
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