<Poseter B28, Page 131 of the Abstract Book>
A Systematic Approach to the Evidence Based Laboratory Medicine in Japan
Masahiro Nishibori, Tadashi Kawai, Takashi Kanno, Masayuki Kambe, Kiyoaki Watanabe, Tsuguya Fukui, Haku Ishida
Clinical Laboratory, Tokyo Medical and Dental University
Objectives
Practice of the evidence based medicine in the field of laboratory medicine requires a more appropriate approach than in other ordinary medical fields, because of the following reasons;
(1) unlike the effectiveness of therapeutic measures which can be evaluated by comparing only two groups of those who are given or not given the tried medicine, there will be almost infinite combinations of various diagnostic tests and various diagnostic phases in the clinical course.
(2) unlike the medication which has direct effects to the patient outcome, many steps are taken to analyze effects of the results of laboratory tests to the final outcome of the patient.
(3) there are many factors which cause various statistical biases of the laboratory data.
The purpose of the project presented in this paper is to organize a national research group of the leading members of related fields in Japan, and then to establish guidelines proper to the evidence based laboratory medicine, and to promote its practice consistently.
Methods
Under the chairmanship of Dr. Kawai, the Director of International Clinical Pathology Center (ICPC), and the vice-chairmanship of Dr. Kanno,the President of Japan Society of Clinical Chemistry, the Committee on Systematic Reviewing in Laboratory Medicine (ICPC/C-SRLM) is organized. It is composed of the following four teams.
(1) Methodology Team (Chief: Dr. Kambe, chairman of the Committee of Laboratory Informatics, the Japan Society of Clinical Pathology), which prepares the standard methodology manual for systematic reviewing (meta-analysis) and the requirements for publishing the manuscripts dealing with clinicl usefulness of diagnostic tests.
(2) Selection Team (Chief: Dr. Watanabe, chairman of the Committee of Utilization of Laboratory Tests, the Japan Society of Clinical Pathology), which selects the subjects suitable to be studied in this project.
(3) Statistics Team (Chief: Dr. Fukui, Professor of Clinical Epidemiology, Kyoto University), which studies and proposes the most suitable statistical methods to be applied in SRLM.
(4) Management Team.
Besides, the Evidence Based Laboratory Medicine Research Project Team (EBLM-RPT, Chief: Dr. Ishida), which was established by the Ministry of Education, Science, Sports and Culture of Japan, collaborates with the ICPC/C-SRLM and prepares a mailing list for efficient discussions and the WWW site to provide the database collected through this project to the public.
Results
The ICPC/C-SRLM was established in April, 2000 and the consensus about the collaboration was established with the EBLM-RPT in May, 2000. Under this framework, the First Study Group on SRLM on High Sensitive CRP Measurement dedicated to the multi-centers clinical study on Japanese populations in the cases of neonatal infections and cardiovascular and cerebrovascular diseases has been successfully conducted.
Conclusions
An unprecedented organization proper to the laboratory medicine for a systematic approach to the evidence based medicine was established in Japan and it is expected to bring a breakthrough in practice of the laboratory diagnosis.
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