平成 12 年度 厚生科学特別研究「EBM を指向した「情報科学センター」機能の設置効果に関する調査研究」（主任研究者：丹後俊郎）総括・分担研究報告書，2001

http://cochrane.umin.ac.jp/pp.pdf
International Symposium on “EBM and Policy Development”
National Institute of Public Health (NIPH)
Tokyo, Japan , 16 February 2001

POLICY AND POLITICS OF
EVIDENCE-BASED MEDICINE IN JAPANKIICHIRO TSUTANI
Dept. of Clinical Pharmacology, Div. of Information Medicine
Medical Research Institute, Tokyo Medical and Dental University

Slide 1

Policy and politics on EBM
in Japan

Policy and Politics of Evidence-Based
Medicine in JapanThe organizing committee of this symposium firstplanned to invite someone from the Ministry of Health,
Labor and Welfare (MHLW) to give this talk but theCommittee was told that the Ministry could not accept theinvitation because they had just merged in January 2001
(the former Ministry of Health and Welfare (MHW) and
Ministry of Labor (MOL)) and were now busy with theirreorganization. The staff in charge of EBM had just beenchanged, and so I was asked to give this talk. I accepted
the invitation for two reasons.

International Symposium on“Evidence and Policy Development”
the National Institute of Public Health (国立公衆衛生院)
Miyako Hotel, Tokyo, Japan
16 February 2001 (Friday)
Kiichiro Tsutani M.D.,Ph.D.
Dept. of Clinical Pharmacology, Div. of Information Medicine
Medical Research Institute, Tokyo Medical and Dental Univ.
1

51

Slide 2

Ministry of Health staff engaged in EBMrelated activities in China

This picture was taken when I attended the last
Cochrane Colloquium in Capetown, South Africa in
October 2000. Dr. Liu Jianping, who is shown on the right,
is the Chinese epidemiologist who is now doing asystematic review of Chinese herbs used in the treatmentof hepatitis. A copy of his paper is on your table and you
will hear his lecture tomorrow at the Tokyo Medical and
Dental University. The two other gentlemen on the left
are senior officials of the Ministry of Health, China.
2

Slide 3

中国衛生部のEBM関連職員

Senior officials related to EBM and the
Cochrane Collaboration in the Ministry of
Health, China

They are Dr. Qi Guoming, Director-General,
Department of Science and Technology, and Dr. Yu
Xiucheng, Director, Division of Scientific Achievementand Exchange (DSTE), both from the Ministry of Health(MOH), China. I was surprised to learn of their
participation at the Colloquium. So far, there has been no
participant from our Japanese Ministry of Health andWelfare to the Cochrane Colloquium, nor from the
National Institute of Public Health (NIPH). After mydiscussions with them, I realized the importance ofgovernment participation in these forums for the further
development of the EBM movement in Japan, including asystematic review, such as the Cochrane Review. So thatis the first reason why I accepted this invitation—to talkabout the policies and politics of EBM in Japan.

• 科技教育司 司長
祁 国明
Qi Guoming, Director-General
Dept. of Sciences, Technology and Education• 科技教育司 成果与交流処処長
干 修成
Yu Xiucheng, Director, Division of ScientificAchievement and Exchange, DSTE
3

Slide 4

News article on the suspension of the
NIPH project on clinical information
database

And this is the second reason. This news item
appeared in one of the health newsletters in Japan inAugust 2000. It reported on the suspension of the project
on clinical information database being established by the
NIPH. The database is planned to include clinicalpractice guidelines and other evidence-based informationsuch as RCTs in Japan. The Liberal Democratic Party(LDP), leading party which is backed by a strong Japan
Medical Association (JMA) was against this project. Now
we ask, why do such things happen in Japan? This is thesecond issue and I thought that I should review the pasthistory and the politics of this issue in Japan.

452GlobalMarch/April

Slide 5Japan

The Cochrane Collaboration
1991

EBM

EBM

JANCOC

Guyatt. ACP Journal Club

1992
1993
15-16 Oct. 1st Cochrane Colloquim (CC) at Oxford

On page 6 of your handout, you will find a tableshowing the major events in Japan and other countries in
the field of EBM. (Tsutani, K. The Cochrane Collaborationand systematic review: its role in the EBM movement.

3 Nov. JAMA User' guides
to the medical iterature series started
1994
5
1-4 Oct. 2nd CC at Hamilton

JAMA 日本語版 医学文献を読むための「利用者の手引き」掲載開始
11.5 第 1 回 JANCOC 会議(東京)4-8 Oct. 3rd CC at Oslo11.5 第 2 回 JANCOC 会議(東京)12.3 第 1 回 SRWS(東京)12.3『コクラン共同計画資料集 ver.1.0』

1996
19-23 Oct. 4th CC at Adelaide

12.1 第 3 回 JANCOC 会議(東京)12.1 第 1 回 HSWS(東京)1997“EBM” by Sackett

6.27「医療技術評価のあり方に関する検討会」報告書"EBHC” by Muir Gray

11.15『コクラン共同計画資料集 ver.2.0』

Koshueisei-kenkyu (Journal of National Institute of Public
Health, 2000； 49(4): 313-9, in Japanese). On the left

(別府，津谷．サイエンティスト社）
20-24 Oct. 5th CC at Amsterdam

12.7 第 4 回 JANCOC 会議(名古屋)
12.7-8 第 1 回 EBM セミナー(名古屋)1998
3.10 『EBM』(訳：久繁．吉冨製薬より配布)
22-26 Oct. 6th CC at Baltimore

12.19 第 5 回 JANCOC 会議(自治医大)
12.19-20 第 2 回 EBM セミナー(自治医大)

1999

1.10 『EBM 実践ワークブック』(名郷．中山書店)

column are the Cochrane Collaboration and EBM eventsat the global lebel, while on the right, the Japanese events(EBM and JANCOC). JANCOC stands for the Japanese
informal Network for the Cochrane Collaboration.
The term “evidence-based medicine” first appearedin the ACP Journal Club, which started in 1991. The first
Cochrane Colloquium was held in 1993. Also in the same
year, JAMA started to publish a series on a reader’s guideto the medical literature. The Japanese translation of the
JAMA series first appeared in 1994, the same year
JANCOC was established. And in 1995, the firstsystematic review workshop was held in Japan, although
on a rather small scale. It was just a half-day workshop.
The hand-search workshop was conducted in 1996. In
1997, the famous book on EBM by David Sackett was
published. That same year, three major events took
place in Japan. One was the publication of thegovernment report on Health Technology Assessment(HTA), in June. In November, the compilation of papers
on the Cochrane Collaboration was published inJapanese. And then, in December, the first EBM seminar
was conducted in Nagoya. This last seminar was very
successful. It would be safe to conclude using Japanesereign style that 1997 is “the first year of EBM era inJapan”, i,e., EBM first started in Japan. Since then there
have been around 50 workshops and seminars on EBM
conducted in Japan, and quite a number of books andjournals on EBM have been published.

2.6 第 2 回 SRWS(東京)2.26 『効果と効率』(訳：森．サイエンティスト社)
3.23 「医療技術評価推進検討会」報告書
3.25 『EBM』(訳：久繁．じほう)6. 1 『EBM 実践ガイド』(福井．医学書院)
9.18 第 3 回 SRWS(名古屋)
5-9 Oct. 7th CC at Rome

9.30 『EBHC』(訳：久繁, 山之内製薬より配布)

2000

1

EBM ジャーナル発行開始

5.1『EBHC』(訳：久繁．じほう)1.15 第 6 回 JANCOC 会議(名古屋)
1.15-16 第 3 回 EBM セミナー(名古屋)25-29 Oct. 8th CC at Cape Town
( EBM: evidence-based medicine,

9.10 『EBM のための情報戦略』（中嶋．中外医学社）
EBHC: evidence-based healthcare,

SRWS: systematic review workshop,

HSWS: handsearch workshop )Major EBM events in Japan and otherparts of the globe

5

Slide 6

The first HTA report in June 1997

As I mentioned earlier, the first report on HTA was
published in 1997 by a group set up by the Government.
The group, which had met six times since December 1996,
consisted of 14 members—7 from academia, 2 from thehospitals, and one each from the Japan Medical
Association (JMA), the Japan Dental Association (JDA), theJapanese Nursing Association (JNA), the National Instituteof Health Service Management (NIHSM), and the Japan
Health Sciences Foundation, a quasi government agency.

「医療技術評価のあり方に関する検討会」報告書（1997.6.27）• 1996.12- 会議6回
• member 14人（大学7, 病院2, 日本医師会, 日本歯科医師会, 日本看護協会, 国立医療・病院管理研究所, (財)ヒューマン・サイエンス振興財団）
653

Slide 7-8

Contents of the 1997 HTAThis is a list of topics discussed in the report, whichcontains a comprehensive discussion of HTA. Quality
assurance (QA) and quality improvement (QI) in healthmanagement, or “Kaizen” in Japanese, are also analyzed. It
includes a survey of the status of HTA in other countries,
such as France, Sweden, the United Kingdom, and theUnited States of America. The report reveals that HTA isin its early stage of development in Japan and should thus
be further developed.

「医療技術評価のあり方に関する検討会」報告書（1997.6.27）(continued)
1. 医療技術評価とは
2. 医療技術評価の位置付けとその関連領域
3. 医療技術評価の現状
4. 我が国における医療技術評価の利用について
5. 医療技術評価の推進に向けて取り組むべきこと
6. おわりに7「医療技術評価のあり方に関する検討会」報告書（1997.6.27）(continued)• Health Technology assessment (HTA)• QA/QI• UK, France, Sweden, USA• Still in early stage development in Japan

8

Slide 9

「医療技術評価推進検討会」
報告書（1999.3.23 ）The second HTA report in March 1999

This is the second HTA report. The composition of
the second group is basically the same as the first. The
group, which also held six meetings, was made up of 7
members from academia, 2 from the hospitals, and one
each from JMA, NIHSM, and the Medical Information
System Development Center (MEDIS-DC), whose
members are experts in medical informatics. Fourmembers were the same as those who prepared the firstreport.

• 1998.6- 会議６回
• member 14人（大学7, 病院2, 日本医師会,国立医療･病院管理研究所, 医療情報システム開発センター）

9Slide 10-11

Contents of the 1999 HTA report

This second report is more focused on EBM. It
mentions about randomized controlled trial (RCT) andmeta-analysis. It is interesting to note that only in thesecond report did the term “randomized controlled trial”
appear. It seems that the concept of randomization was
not well recognized even by the very senior health officials
or academicians in Japan. Now they seem to understandthe concept better, and have discussed it. Meta-analysis
54was briefly mentioned, as well as AHCPR National
Guidelines Clearinghouse in the United States and theCenter for Review and Dissemination (CRD) in U.K. I was
actually invited to give a talk on the activities of the
Cochrane Collaboration.
The report concludes that there should be evidencebased clinical practice guidelines. Hence a priority list of
topics that focused on evidence-based clinical practiceguidelines was developed. Another conclusion arrived at
was that more understanding on clinical research,
including clinical trials, is needed, because only by theparticipation of the patients/public in clinical research
can strong evidence be generated. It has had a negative
image before. So in order to improve clinical research,
this group decided that there should be more advocacy
and educational activities to the public. However, someitems seems missing in the project. For instance, theregistration of clinical trials sponsored by either
government or the pharmaceutical industry, which ismainly aim to reduce publication bias and may contributeto improve the image of clinical trials is not wellrecognized in Japan.

「医療技術評価推進検討会」
報告書（1999.3.23 ）(continued)
1. はじめに
2. 医療技術評価とEBMについて
3. EBMについて
4. 医療技術評価とEBMの総合的推進について
5. EBM推進のための環境整備について
6. 国民の臨床研究への理解と協力について
7. おわりに10「医療技術評価推進検討会」
報告書（1999.3.23 ）(continued)• RCT, MA• AHCPR, National Guideline Clearinghouse• Center for Review and Dissemination(CRD)• The Cochrane Collaboration• Evidence-based clinical practice guidelines
topics: priority setting• Understanding from the public
11

Slide 12

ＥＢＭの推進に関する研究（１）FY1999 (平成11年度）

医療技術評価総合研究事業
Clinical practice guidelines
1. 糖尿病（赤沼）2. 高血圧（藤島）3. 泌尿器科領域（大島）4. 急性心筋梗塞及び他の虚血性心疾患（上松瀬）5. 喘息（宮本）1. 糖尿病（赤沼）2. 高血圧（藤島）3. 泌尿器科領域（大島）4. 急性心筋梗塞及び他の虚血性心疾患 （上松瀬）5. 喘息（宮本）6. 胃潰瘍（菅野）7. 脳梗塞（福内）
8. 白内障（小原）9. 腰痛症（白井）10. 慢性関節リウマチ（越智）11. クモ膜下出血 (吉峰)12. アレルギー性鼻炎（馬場）Infrastructure development
1. ＥＢＭを支えるリサーチライブラリアン養成についての研究 （中嶋）（FY1998平成１０年度の特別研究から）

The EBM project begins

During the fiscal year 1999, the actual projectsponsored by MHW, under the category of HTA, started
with the development of the five guidelines. Eachguideline cost JYE 30,000,000 or around US$ 300,000 for
two years. The total budget for the fiscal year 1999 was
JYE 80,000,000 or nearly US$ 1 million, including an
information infrastructure project for training program
development for a research librarian supporting EBM.
For the fiscal year 2000, about US$ 4 million has beenspent, with additional seven guidelines being developed
and additional information infrastructure projects
initiated or continuing. These projects include: theelectronic search and hand search project; a training
program and preparation of a syllabus for physicians;classification of nursing; development of an EBM support
system which main activities is translation of “Clinical
Evidence” into Japanese; an EBM database development;
and, finally, one on alternative medicine. So now there are
8 ongoing projects.

FY2000 (平成１２年度)

1. ＥＢＭを支えるリサーチライブラリアン養成についての研究（中嶋）
2. 日本の既存医学データベースをＥＢＭに生かすためのエレ
クトロニッ ク サーチ・ハンドリサーチの方法論の開発とデータベース改良に関する研究（津谷）3. ＥＢＭ普及のためのシラバス作成と教育方法に関する研究（福井）
4. わが国における看護実践国際分類の妥当性と普及に関する研究（岡谷）5. ＥＢＭ普及支援システムの開発に関する研究（小泉）6. 日本におけるＥＢＭのためのデータベース構築および提供
利用に関する 調査研究（丹後）7. 標準データ項目セットを用いた知的データベースによる診療根拠の動的 生成に関する研究（山本）8. 相補・代替医療の評価と保健サービスにおける位置づけに
12関する研究 （丁）55

Slide 13
FY1997 (平成9年度）

FY1998 (平成10年度）

FY1999 (平成11年度）

FY2000 (平成12年度）

特別研究
医薬品の適応外使用に関するエビデンス(津谷)(その後FY1998-2000はHS財団へ）（その後FY1999-2001は医療
ＥＢＭを支えるリサーチライブラ
リアン養成についての研究 （中嶋） 技術評価総合研究事業へ）
２１世紀の保健･医療･福祉におけるEBMによる新しい情報提供機能の確立のための調査研究(丹後)EBMを指向した「情報科学センター」機能の設置効果に関する研究(丹後)特定疾患調査研究
特定疾患に関する緊急研究
EBM導入研究 (福井)EBM projects under other programs

Aside from these there have been several projects on
EBM under the category of “special research” sponsoredby the MHW. The first one was Evidence for Off-LabelUse of Drugs, for which I was the principal investigator in
FY 1997. This was actually continued by another agency,
the Japan Health Sciences Foundation, a quasigovernment agency, for three years FY1998-2000. The
training program development for the EBM researchlibrarian project was originally under the category of
special research in FY1998.
And in FY1999 there was a project hosted by the
National Institute of Public Health (NIPH) under Dr.
Toshiro Tango. This project is for “the new information
retrieval system in the 21st century.” This was succeededby a project “Research on the impact of development of
information science center based on EBM. ” Actually, thisproject resulted from the idea of setting up an EBM
information center using a model of the Cochrane Center.
In FY 1999 there was another project on “How to
introduce the EBM concept in special or intractablediseases or diseases.” There is also a continuating project
on information management in this area in FY 2000.

ＥＢＭの推進に関する研究（2）

科学的根拠に基づいた
難病診療における情報管理に関する研究 (佐藤)13

Slide 14

Two misunderstanding

There are altogether more than 20 EBM projects
under the HTA program and others. The development of
EBM has seemed to be going on smoothly in Japan. The
reality, however, is different. There are actually two
misunderstandings currently going on. There is the
misunderstanding on the process of clinical practiceguideline development. Some people consider suchguidelines very restrictive in that they aim to control
physicians’ behavior. It is felt that the guidelines arebiased towards reducing health costs in Japan. The othermisunderstanding is on EBM itself.

２つの誤解• Process of clinical practiceguidelines development• EBM itself
1456

Slide 15

Evidence-based Medicine is ・・
Clinical
expertise /circumstance
Research
evidence

Three component in EBM

I first clarify the misunderstanding of EBM. This isfrom the second version of David Sackett’s textbook on
EBM in 2000. EBM does not consist only by evidence. It is
an integration of best-researched evidence with clinicalexperience and patient values.

Preference,
Value

1996/1997 “the conscientious, explicit and judicious use ofcurrent best evidence in making decisions about
the care of individual patients”
2000“the integration of best research evidence with15
clinical expertise and patient values”

Slide 16

Three phase of evidence

There are three phase of evidence;First is tsukuru, generation evidence through valid clinical
trial.
Second is tsutaeru, evidence are searched, appraised,synthesized and disseminated.
Third is tsukau, physicians, government officials,
consumers and others use it

Evidenceを• つくる
tsukuru ・・ clinical trial• つたえる tsutaeru ・・ The Cochrane
Collaboration• つかう tsukau ・・ various users

16
YA80830-03

Slide 17

The fathers of EBM

It is said that there are three fathers of EBM
development: Archie Cochrane, Alvan Feinstein, andDavid Sackett.

EBMの３人の父
１．Archibald L. Cochrane(1909-88)
２．Alvan R. Feinstein(1925-)
３．David L. Sackett(1934 -)
17

57

Slide 18

Archie CochraneThis is Archie Cochrane. He said three things.

18

Slide 19

Cochrane’s theses

One is that all effective treatment must be free.
During its developmental stage in the United Kingdom, theNational Health Service (NHS) had for its political slogan -“All treatment must be free”. Cochrane, however, had adifferent view. He said that “All effective treatment must
be free”.
So how can we find out if a treatment is effective? His
answer to this was the randomized controlled trial. This is
the second point.
He also said that all clinical trials should be criticallyreviewed and appraised, results synthesized then, without
delay, these results should be disseminated to persons inneed of the information. This process is now called the‘systematic review’.

Cochrane の言った3つの事
1. All effective treatment must be free.
2. RCTの重要性
3. ‘Systematic Review’の重要性(1) すべてのRCTから(2) よいものだけを(3) まとめて(4) 遅れなく(5) 必要な人に届ける
19

Slide 20Seven steps of Systematic review

The method of systematic review consists of sevensteps as follows: (1) Formulating the question; (2) Locating
and selecting studies; (3) Assessing the validity of thestudy; (4) Collecting data; (5) Analyzing and presenting theresults; (6) Interpreting the results; and (7) Editorial
process and updating the review.

20

58

Slide 21

From primary analysis to meta-analysis
A synonym of “systematic review” is meta-analysis,
although in the Cochrane Collaboration the word “metaanalysis ” is confined to the mathematical method insynthesizing.
If you develop a protocol, execute a trial and analyze
the result, you have what is called “primary analysis”. The
same data set may be analyzed by anyone else, which isthen called secondary analysis. If there are more than two
studies on the same research question, meta-analysis isused. And this is now called systematic review, which canthus be divided into: (1) systematic search, and (2)synthesis. The first part is very similar to the one used inclinical practice guideline development.

Systematic Reviewとは？
• Primary Analysis• Secondary Analysis• Meta-Analysis→ Systematic Review→ Clin. Prac. Guidelines
21

Slide 22

診療ガイドラインの品質保証はどのようになされるか？

Quality assurance of clinical practiceguidelines

How can quality assurance of clinical practiceguidelines be made possible? Quality can be only bemaintained through transparency in the development
process. If there is a clear description of the wholeprocess, then people will understand these guidelines
better.

How the quality assurance of clinicalpractice guidelines is made?

作成プロセスの明示性
Explicity of development process
22

Slide 23

Implication ofclinical practice guidelines

Implications of clinical practice guidelines

Now we also have to consider the implications—how
the guidelines should be disseminated to physicians andothers who may benefit from them and how they can beused. The answer is already mentioned in my explanation
on EBM. Evidence in the form of clinical practiceguidelines should be used in the integration of clinicalcircumstances and patient value.

• How the guidelines should be
informed to the physicians ?
• Who will use it ?
• How to use it ?
23

59

Slide 24 Fifty years of randomized controlled trials
During the last three days, Dr. Joseph Lau from
Boston and Dr. Liu Ming from Chengdu , China, conducteda systematic review workshop and during his lecture, Dr.
Lau introduced some historical developments in
randomized controlled trials using pictures. It was in1948, when the first randomized controlled trial was
published in the 30 October issue of British Medical
Journal. It was a trial using streptomycin on pulmonary
tuberculosis patients, a project headed by Dr. Austin
Bradford Hill. This is a photo of some of the participantsat the 50-year anniversary symposium of RCT held in
London in 1998. Two of them are British, the rest
Japanese. The person on second right in the back row is
Dr. Iain Chalmers, Director of the U.K. Cochrane Centerand developed the idea of the Cochrane Collaboration.
Actually Dr. Archie Cochrane was his teacher. The next
person is Dr. Richard Peto, a well-known biostatistician
from Oxford

24

Slide 25 First randomized controlled trial in Japan
This is the report of first randomized controlled trial
conducted by a Japanese in Japan - a RCT in the
chemotherapy of tuberculosis. It was conducted in 195758 and published in 1960. This trial involved 114 national
tuberculosis hospitals. But before this trial, there had
been a trial conducted in Japan, although not by aJapanese.

25

Slide 26

Two factorial designs

It was conducted by Dr. Thomas Chalmers, an
American researcher.
This study used two-by-two
factorial designs-one prescribed strict bed rest vs ad lib
rest, and the other, forced diet vs ad lib diet. The patientswere randomly assigned to four wards.

26

60

Slide 27

Soldiers in the Korean War

All the patients who participated in the trial were
American soldiers who were infected with acute hepatitis
during the Korean War of 1950-1951.

27

Slides 28 The US Army Hospital
The trial was conducted at the former Kyoto Red
Cross Hospital, which was occupied by the Americans
during the Korean War and later renamed the US Army
Hepatitis Center. This figure in the trial paper in 1955
shows how the random assignments were made in the four
different wards. Wards 21 and 23 on the second floor andWards 41 and 43 on the fourth floor were used for thistrial—the first ever randomized trial conducted in Japan.
Unfortunately it was planned, conducted, and analyzed byAmericans only. There was no Japanese involvement.
28

61

Slides 29-30

The Kyoto International Red Cross
HospitalThis is the picture taken in 1991 by my friend in
Osaka, which is close to Kyoto. You can see the same
curved wall of the building, which was shown in the figure.
Last February I visited the hospital when I gave a lecture
at the Kyoto University, but I found that the building had
been renovated and the impressive curved wall had
disappeared.

29

30

Slide 31

The Journal of Clinical Investigation

This is the journal in which this study was published.

31

62

Slide 32

Dr. Thomas Chalmers

This is a picture of Dr. Thomas Chalmers, of theTechnology Assessment Group at the Harvard School of
Public Health. Actually he told me about the existence of
this trial of 1951 and gave me a copy of the paper when I
was in Boston in 1990.

32

Slide 33

However, even before 1950, there had been a similar
trial done in Japan by Dr. Kanehiro Takagi, the DirectorGeneral of the Department of Medical Service of theJapanese Navy.
This is an excerpt from an article that appeared in
The Lancet in 1906. This was a prevention trial of beriberi
among Japanese sailors on separate voyages of two
Japanese navy ships in the South Pacific. The sailors on
the first voyage by Rhujo in 1882 ate ordinary Japanesewhite rice. Out of the 376 soldiers, 169 caught beriberi
with 25 deaths. The sailors on the second voyage by
Tsukuba in 1884 ate Western food, consisting mainly ofbread and meat. Out of 333, only 16 soldiers caught
beriberi with no deaths. After the trial, Dr. Takagi
ordered to change all the sailors’ food from white rice towestern food, i.e. bread and meat. However, westernfood was very expensive at that time. So they substituted
boiled wheat for boiled rice. The number of beriberi cases
among navy sailors sharply decreased. He later became
Baron. The trial, however, at that time was criticized by
the army, represented by Dr. Rintaro Mori, who wasstudying hygiene in Germany at that time, and argued
that the trial was not a concurrent comparison. He later
became Director-General of the Department of Medical
Service of the Japanese Army. He was also a very famousnovelist with the penname Ogai Mori.

高木兼寛の脚気trial+

Beriberi(death) -total

龍驤(1882.12.19-83.10.15 169 (25)

207

376

NZ, Chile, Peru, Hawaii)
筑波(1884.2.2-11.16)
16
NZ, Chile x2, Hawaii)

317

333

( 0)

Study on beriberi by Dr. Takagi.

ref: Baron Takaki Lancet 26 May 1906: 1451-5
山下政三. 明治期における脚気の歴史. 東大出版会, 1988
33

63

Slide 34 Dr. Mori’s critical appraisal of Dr. Takagi’strial

森林太郎によるcritical appraisal

Dr. Mori made a very critical appraisal of Dr. Takagi’s
trial. He said that the soldiers should have been divided
into two—one group who ate wheat and the other who ate
rice. Both groups should have been in the same place atthe same time in order to avoid selection bias. Dr. Mori
did not use the results of Dr. Takagi’s trial. He insisted
that Japanese army soldiers should eat white rice.
However, because of his decision, several thousand
Japanese army soldiers died during the two wars—the
Sino-Japanese War and the Russo-Japanese War. Dr.
Takagi was actually trained at the St. Thomas University
under Dr. John Simon in London while Dr. Mori wastrained in Germany under Dr. Max von Pettenkofer and
Dr. Robert Koch.

「兵団を中分し、一半には麦を給し、一半には米を給し、両者をして同一の地に住
まわしめ・・」
森林太郎. 統計に就いての分疎.東京医事新誌第584号1889.6.8
森欧外. 統計に就いての分疎. 鴎外全集 第28巻,1974: 227-42

34

Slide 35-36

Post (cum) hoc propter hoc

In the Ogai collection at the General Library of the
University Tokyo, I found the German book used by which
Dr. Mori in his study of statistics and researchmethodology. In one page of the book, I found his
underlined entries and notes he penciled in Chinese. It
was a translation of the Latin phrase Post (cum) hoc
propter hoc, which means “after it therefore because of it”.
The title of the book is Medicinische Logic by FR
Oestelen, published in Tublingen in 1852. You can see
seal of Mori's collection on the inside front page. So heknew the logic of causality and he made a criticalappraisal of Dr. Takagi's trial using his knowledge of it.

35

36

64

Slide 37

Lessons learnt from this case

What conclusions can we draw from this case?
Several thousand army soldiers, who subsisted mainly on a
Japanese rice diet, died. While Dr. Takagi’s study brought
out some significant results, it had weak evidence. The
trial, of course, was not randomized because it was done
before the concept of randomization was invented in the
1920s-1930s in the UK, by Dr. Ronald A. Fisher in the
agricultural field. At the time of the trial, the cause ofberiberi was unknown and some even considered it aninfectious disease. While Dr. Mori was methodologicallyright—he argued that stronger evidence was needed—his
action was wrong. So if you are an army medical officer
responsible, for instance, for 1000 soldiers in your front,
and you find yourself in such a situation, what decision
would you make? If your decision was based on hard
evidence, you might still make the soldiers eat white riceand they might die of the disease. So who should make thedecision and who should be responsible for that decisionmaking?

What we can learn from this case ?
• Several thousands army soldiers died during twowars• Dr. Takagi: weak evidence, but action was right.
It hit truth.
• Dr. Mori: methodologically right, but action was
wrong.
• If you are army medical officer responsible 1000
soldiers in your 部隊, and you have experiencesthat 麦飯 prevent and cure beri beri, what
decision you will make ?
• Who will make decision and who will be
responsible ?
37

Slides 38

Article from Yomiuri Shimbun

When the plan to establish an Clinical Information
database which is who called as EBM information Center
in NIPH was announced, it was welcomed as a movetowards clinical decision-making based on scientificevidence rather than experience. This is a newspaper
article from the 21 August 2000 issue of Yomiuri Shimbun,
which was welcomed by the public.

38

Slides 39

Article from medial fax news

This medical fax news of 28 August, published a week
after the news in Yomiuri Shinbun, reported that LDP wasagainst the plan.

39

65

Slides 40

Letter in Asahi Shimbun

This letter by Dr. Takateru Izumi, specialist in
infectious lung diseases at the Kyoto University, appearedin the 25 October 2000 issue of Asahi Shimbun. He argued
for the need for clinical practice guidelines.

40

Slides 41

Letter in Saitama Shimbun

This article, which appeared in the 26 October 2000
issue of Saitama Shimbun, reported that the Japanese
Medical Association (JMA) did not like dealing withgovernment-led activities. The EBM Information Center
in NIPH, which will contain a database of Clinical Practice
Guidelines was caught in a deadlock and was subsequently
terminated.

41

Slide 42

Problems

Who will lead the EBM movement inJapan?

The question is: Who will lead the EBM movementin Japan? Will the leadership come from the Governmentside or the non-government side? Also, there is some
psychological issue here. People all over the world do not
like to be dictated upon by others. The same may be saidof the JMA. Aside from this, there is also the problem ofterminology, i.e., the different interpretations of guidelines
in Japan.

• Who will lead EBM movement in Japan ?
- Government Organization (GO) or
Non Governmental Organization (NGO)- Psychology• Terminology- What guidelines means ?
42

66

Slide 43-44

Terminology• August 2000
• meeting of 12 teams of development ofclinical practice guidelines• 治療ガイドラインclinical practice guidelines
or 治療エビデンス集 (collection ofevidence ?)43

Terminology
治療guidelines
pre-appraised
時間短い
制限的

Terminology

There was a meeting at the Ministry of Health andWelfare (MHW) in August 2000 to discuss the intermediate
evaluation of a draft version of the clinical practiceguidelines developed using MHW funds. It also planned
to conduct training on methodology of developing
guidelines. Two each from the twelve teams responsiblefor developing guidelines were gathered in a session,
where Dr. Tsuguya Fukui from Kyoto University, Dr.
Akinori Hisasige from Tokushima University, Dr. Toshiro
Tango from NIPH and I served as trainers. Just before
that meeting, we were told by one of the MHW staff thatthey would not use the term “clinical practice guidelines”.
He said they would just use the term “collection ofclinical evidence”, but the content was the same. The
meeting between top officials of MHW and JMA reached
the conclusion that the term “guideline” was too strong
for JMA.
The guideline was a sort of pre-appraisal review. It
was based on evidence-based pre-appraisal review. For
the user it takes shorter time but it sounds too restrictive.
While collection of clinical evidence allows physicianssome kind of self-appraisal. Though it may take sometime, physicians can nevertheless enjoy the freedom of
choice as professionals.

治療evidence集
self appraisal
時間長い
自由

44

Slide 45

Example of Clinical Practice Guidelines
by AHCPR

It is worthwhile to mention that similar incidents
happened in the US a couple of years ago. This website
includes a table of contents for the clinical practiceguidelines on low-back problem in adults. This guideline,
developed by the Agency for Health Care Policy andResearch (AHCPR), was severely criticized by someorthosurgeons, who believed that the guidelines would
reduce the number of surgery operations. They lobbied
against it before the US Senate and the budget was
drastically cut down. Thus the development of clinicalpractice guidelines at AHCPR was stopped. AHCPR was
renamed to Agency for Healthcare Research and Quality(AHRQ) in 1999, and now AHRQ is developing evidence
reports instead.

45

67

Slide 46

Example of Evidence Report by AHRQ on
Acute Bacterial Rhinosinusitis

This is the table of contents for the evidence report onacute bacterial rhinosinusitis. The systematic review andthe development of the report was conducted by Dr. Lau’sgroup. Unlike the guidelines there is no clear
recommendation in the evidence reports, which always
end with the same conclusion, i.e., further studies areneeded.

46

Slide 47

Decision-making support system
The development of guidelines or evidencecollection/report is part of a decision-making support
system. But you also have to consider for whom thesereports are made. Are they for the public health officer,
clinician, or patient? In what form will they be provided
and how many health sectors will be involved in thedevelopment and distribution?

意思決定サポートシステム
decision making supporting system
誰のため (for whom ?) ・・
行政官(public health officer)
臨床医(clinician)患者(patient)
どのようなかたちで(in what form ? )47

Slide 48

Who is responsible?

Also, who will be responsible for this decisionmaking? As I mentioned to you earlier, if you were anarmy medical officer, you had to make a decision. Publichealth officers or those involved in guideline development
may take responsibility. Physicians also may takeresponsibility, at the same time claiming professional
freedom. But the professional code among physicians isseldom argued, which is a weak point in Japan andtherefore has to be improved. Nowadays in Japan,
patients want more information. Patients may also takeresponsibility based on their autonomy. That is why we
now have informed consent or informed choice.

誰が責任？(who is responsible ?)• 行政官(public health officer)/ team of clinical practice guidelines• 臨床医 (clinician)- professional freedom- professional code
• 患者(patients)- informed consent/choice48

Conclusion
This is my analysis of the current situation, or at least the last 5 years of the EBM movement in Japan. It has been
decided that major health care reform will take place in FY 2002 in Japan. I hope that within the next one year and beyond,
all the conflicting issues of EBM will be resolved and a system established which will serve the people’s health.
Thank you.

68

平成 12 年度厚生科学研究費補助金厚生科学特別研究事業
EBM を指向した「情報科学センター」機能の設置効果に関する調査研究
2001 年 3 月 31 日 発行
主任研究者

丹

後 俊

郎

連絡先 国立公衆衛生院附属図書館〒108-8638 東京都港区白金台 4-6-1
TEL 03-3441-7111 FAX 03-5421-7481

©2001

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