editorials original articles - semantic scholarpreoperative tnm staging of advanced gastric cancer...

Vol.48, No.4 April 2005

Editorials

JMAJ’s Future Policy and Notice of Renewal

Haruo Uematsu ...................................................................................................................................................... 161

A New Era for the Journal

Tsuguya Fukui ........................................................................................................................................................ 162

Original Articles

The Ecology of Medical Care in Japan

Tsuguya Fukui, Mahbubur Rhaman, Osamu Takahashi, Mayuko Saito, Takuro Shimbo,Hiroyoshi Endo, Hanako Misao, Shunnichi Fukuhara, Shigeaki Hinohara ................................................. 163

School Health Research in Low-Income Countries in East Asia and the Pacific

Masamine Jimba, Krishna C Poudel, Kalpana Poudel-Tandukar, Susumu Wakai ...................................... 168

Preoperative TNM Staging of Advanced Gastric Cancer with Multi-Detector RowComputed Tomography

Toshihiko Shinohara, Shigekazu Ohyama, Toshiharu Yamaguchi, Tetsuichiro Muto,Atsushi Kohno, Toshihiro Ogura, Yo Kato, Mitsuyoshi Urashima ............................................................... 175

Review Articles

Epidemiology of Kawasaki Disease in Japan

Ritei Uehara, Yoshikazu Nakamura, Hiroshi Yanagawa ................................................................................ 183

Current Treatment Strategies for Coronary Disease in Japan

Ryo Koyanagi, Naomi Kawashiro, Hiroshi Ogawa, Yukio Tsurumi, Hiroshi Kasanuki,Katsumi Nakata ...................................................................................................................................................... 194

Current Activities of JMA

Policy Address

Haruo Uematsu ...................................................................................................................................................... 201

Current and Future Issues in Continuing Medical Educationby the Japan Medical Association

Nobuya Hashimoto ................................................................................................................................................ 204

Medical News from Japan

“Medical Ethics”—Efforts of JAMS Specialty Societies in Japan—

Yasuhiko Morioka, Takeshi Motegi ................................................................................................................... 209

161

Editorials

JMAJ, April 2005 — Vol. 48, No. 4

JMAJ’s Future Policy and Notice of Renewal

Haruo Uematsu*1

The Japan Medical Association (JMA) isan academic professional organization withapproximately 160,000 members. JMA’s mis-sion is to ensure that the universal healthinsurance coverage, which has been highlyregarded internationally, be maintained, andto ensure a system with which safe, high-quality medical care can be provided efficientlyto every citizen throughout the nation.

JMA is conducting a wide range of activi-ties, such as the heightening of medical ethics,improving medical technologies, integratingmedicine and related sciences and continu-ing medical education.

In the realm of international activities,JMA has played an important role in inter-national organizations, for example, as theSecretariat of the Asia and Oceania Regionof the World Medical Association (WMA)and Secretariat of the Confederation ofMedical Associations in Asia and Oceania(CMAAO). Through the activities of theseorganizations and communication with medi-cal associations in different countries, wehave exchanged information and discussionsto make a significant contribution to thedevelopment of the international medicalcommunity and the enhancement of peo-ple’s health.

As part of its international activities,JMA also founded Takemi program forInternational Health in cooperation with theHarvard School of Public Health in 1983.

This program has cultivated many profes-sionals in healthcare who are now working atthe forefront in each country.

In conjunction with these activities, JMAhas been publishing a monthly academicjournal, The Asian Medical Journal inEnglish since 1958 to introduce the world toquality Japanese medical science and clinicaltreatment. The name of the journal waschanged to The Japan Medical AssociationJournal (JMAJ) in 2001 as the JMA’s mes-sage to the world.

JMAJ has carried high-quality articlesselected and translated from those publishedin The Journal of the Japan Medical Associa-tion. This time, however, we have decided tochange the editorial policy completely andrelease it as a new English journal of medicalscience and care that can be highly regardedon the international stage.

It would be our greatest pleasure if thisJMAJ, with a history spanning nearly 50years, can be reborn by this innovativechange of contents as a medical magazinethat facilitates international academicexchanges, and contributes to the advance-ment of international medical standards.

*1 President, Japan Medical Association, Tokyo, JapanCorrespondence to: Haruo Uematsu MD, PhD,Japan Medical Association, 2-28-16, Honkomagome, Bunkyo-ku,Tokyo 113-8621, Japan. Tel: 81-3-3946-2121, Fax: 81-3-3946-6295,E-mail: [email protected]

162 JMAJ, April 2005 — Vol. 48, No. 4

A New Era for the Journal

Tsuguya Fukui*2

(Editor-in-Chief)

It is my utmost pleasure to present this issueof the newly revamped Japan Medical Asso-ciation (JMA) Journal (the Journal) to allreaders inside and outside of Japan. TheJournal now has a totally different look andcontent from past issues published duringits almost 47 years of history, including itspredecessor, the Asian Medical Journal.

Past issues essentially carried Englishversions of articles already published inJapanese in the JMA’s official journal, theJournal of the Japan Medical Association.It has been my longtime desire to see theJournal develop into a high standard generalmedical journal carrying original and reviewarticles closely related to clinical practiceand news of medicine, medical care, andhealth policy in Japan, like the JAMA fromthe USA and the BMJ from the UK. My highhopes for such a journal coincided with thevision held by Dr. Nobuya Hashimoto, theExecutive Board Member in charge of aca-demic affairs in the JMA under the leader-ship of Dr. Haruo Uematsu, who took thehelm in 2004.

Assuming editorship of the Journal inmid-2004, I immediately proceeded to the

*2 St. Luke’s International Hospital, Tokyo, JapanCorrespondence to: Tsuguya Fukui MD, MPH, PhD, St. Luke’sInternational Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560,Japan. Tel: 81-3-3541-5151, Fax: 81-3-5550-4114,E-mail: [email protected]

task of revitalizing the Journal. With the helpof my associate editors, Drs. MitsuyoshiUrashima and Hideki Hashimoto, and mycolleagues at the editorial office, I feelwe have succeeded in recreating the Journalas a general medical journal which will berepresentative of the medical community ofJapan. The Journal is now a peer-reviewedscientific journal carrying original articles,review articles, short communications andcase reports, and correspondence, amongothers.

I sincerely hope that many readers amongpracticing physicians and researchers inclinical medicine and health service, insideand outside of Japan, will submit pertinentarticles, making the Journal the stage for dis-cussions on medical issues of internationalrelevance and that, in the years to come, wewill see many scientific achievements inmedicine become more widely known inter-nationally through the Journal.

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Original Article


*1 St. Luke’s International Hospital, Tokyo, Japan*2 St. Luke’s Life Science Institute, Tokyo, Japan*3 Dept. of General Medicine and Clinical Epidemiology, Kyoto University Graduate School of Medicine, Kyoto, Japan*4 Dept. of Control, Prevention and Eradication, Communicable Diseases Programme, World Health Organization, Geneva, Switzerland*5 Dept. of Medical Epidemiology, Kyoto University School of Public Health, Kyoto University Graduate School of Medicine, Kyoto, JapanCorrespondence to: Tsuguya Fukui MD, MPH, PhD, St. Luke’s International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan.Tel: 81-3-3541-5151, Fax: 81-3-3544-0774, E-mail: [email protected]

The Ecology of Medical Care in Japan

JMAJ 48(4): 163–167, 2005

Tsuguya Fukui,*1 Mahbubur Rhaman,*2 Osamu Takahashi,*3 Mayuko Saito,*2

Takuro Shimbo,*3 Hiroyoshi Endo,*4 Hanako Misao,*2 Shunnichi Fukuhara,*5

Shigeaki Hinohara*1,2

AbstractBackground Studies on the ecology of medical care have been reported only from the USA. Nosimilar investigation has been made for Japanese population.

Objective To sketch health care seeking behavior of people in Japan based on a prospective healthdiary recorded for one month.

Material and Methods A population weighted random sample from a nationally representative panelof households was used to estimate the number of health-related symptoms, self-care, and health careutilization per 1,000 Japanese population per month. Variations in terms of age, sex, and region werealso examined.

Results Based on 1,286 households (3,477 persons: 2,451 adults and 1,026 children), on averageper 1,000 persons, 862 had at least one symptom, 307 visited a physician’s office, 232 a primary carephysician, 88 a hospital-based outpatient clinic, 49 a professional provider of complementary oralternative medical care, 10 a hospital emergency department, and 6 a university-based outpatientclinic. Seven were hospitalized, 3 received professional health care in their home, and less than 1 wasadmitted to a university hospital. Children had more physician and emergency visits, and rural peoplewere more likely to be hospitalized compared with the average figures. Females were more likely thanmales to have symptoms and to visit their physician while the reverse was true for emergency visits.

Conclusions Compared with the data from the USA, more people visit physician offices and hospitalbased outpatient clinics in Japan. Results of this study would be useful for further delineation of healthcare seeking behavior of people in the context of a health care system unique to Japan.

Key words Ecology, Medical care, Physician visit, Primary care, Health diary

main bulk of the health service utilizationoccurred at physician visits (250 out of1,000 per month) with hospitalization only 9incidences out of 1,000. This ecology modelhas been replicated over the decades,2–5 withfindings that were consistent with those ofWhite et al. Furthermore, this model has

Introduction

More than 40 years have passed since Whiteet al.1 reported the first study on the ecologyof medical care based on the population ofthe USA and UK. They showed that the

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been widely referred to by policy makersand educators.6–9

Unlike the medical system in the USA,Japan has a universal health care system,which allows free access to everyone. In arecent study, it was reported that Japan,compared to the USA, spent considerablyless money on health care in terms oftotal health spending per capita (US$ 2,012vs. 4,631) and percent of gross domesticproduct (GDP) (7.8% vs. 13.0%).10 Thus,it is speculated that the Japanese people’shealth care seeking behavior and healthservice utilization could be different fromthat in the USA. However, no well-designedstudies on patients’ health seeking behaviorfor health-related symptoms were previouslyconducted, although there were reportslimited to very small sample sizes.11,12

The objective of this study was to examinehealth care seeking behavior of people inJapan using a nationally representative panelof households.

Materials and Methods

Study designProspective cohort design was employed.

SampleA nationally representative panel, comprisedof 210,000 households, belonging to JapanStatistics & Research Co. Ltd., was used.Taking into consideration the size of thecities, towns and villages, a populationweighted random sample of 5,387 householdswas chosen and each household was sent anoffer letter with a return envelope. Of thetotal, 1,857 agreed to participate. The samplesize was readjusted to 1,464 households tomake it nationally representative.

Data collectionQuestionnaires and diaries were used for datacollection. The questionnaires were scriptedto note individuals’ baseline characteristicsincluding past medical history. The diarywas to keep record of any health related

events, symptoms, health-seeking behavior,and actual use of health services alongwith other variables of interest. For childrenyounger than 13 years and those who couldnot write on their own, parents/othereligible persons were asked to fill out thequestionnaires and diaries for them. Theadvantages of health diaries are that theycan allow continuous and live recall ofevents. Utilization of diaries has shownhigher compliance13 and has been found tobe useful where the researcher does nothave direct access to the situation.14 It isa highly suitable methodology for literatepopulations.15

After obtaining informed consent by post,health diaries (divided into two parts, eachtwo weeks duration), questionnaires forrecording baseline data and gift vouchersof about 30 US$ per person were sent toeach member of the 1,464 households inSeptember 2003. The diaries were recordedfrom October 1, 2003 till October 31, 2003.A manual accompanied the health diaries tofacilitate recording the required information.The diary was in the form of a softbound A4book. The participants were asked to returnthe first part of the diary after entries weremade for 15 days while the second part wasreturned after the completion of the studyperiod. A phone call per week per family wasmade as a reminder.

Ethical approval was obtained fromthe Research Ethics Committee of KyotoUniversity Graduate School of Medicine,Japan.

Statistical analysisDescriptive analyses, along with confidenceintervals, were performed to estimate thenumber of different health care seekingbehaviors per 1,000 of the population in amonth.

Results

Of 1,464 households, 1,359 households (3,658persons) returned both parts of the diary at

Fukui T, Rhaman M, Takahashi O, et al.


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Fig. 1 Monthly prevalence estimates of symptoms and health care utilization in Japanese populationEach box does not necessarily represent a subgroup of the larger box, i.e., some values are overlapping.The values are based on 1,000 persons.

MEDICAL CARE IN JAPAN


1,000 persons

49 visit a complementaryor alternative medicalcare provider

88 visit a hospitaloutpatienat clinic

862 report symptoms

307 visit physician’s office(232 visit a primary carephysician)

10 visit an emergencydepartment

7 are hospitalized

6 visit a universityhospital outpatientclinic

3 receive homehealth care

the conclusion of the time period. The datawere complete for 3,477 persons out of thetotal 3,568 persons. Most of the respondentswere females (53.2%) and adults (70.5%�18 years old). Area-wise, 17% were fromlarge cities, 24% from medium-sized cities,38% from small towns, and 21% from ruralareas.

Figure 1 shows the incidence of differenthealth care seeking behavior in the modelof ecology of medical care. Of 1,000 peoplein Japan, our estimates on average in amonth show 862 had at least one symptom,307 visited a physician’s office, 232 aprimary care physician, 88 a hospital-basedoutpatient clinic, 49 a professional providerof complementary or alternative medicalcare, 6 a university-based outpatient clinic,and 10 an emergency department. Sevenwere hospitalized, 3 received health carein their home, and less than 1 (0.3) wasadmitted to a university hospital.

Table 1 shows the variation of health careseeking behavior in terms of age, sex, andarea of living. Children had more physicianand emergency visits, and rural people hadmore hospitalization compared with theaverage figures. More females had at leastone symptom, physician and outpatient visits,while the reverse was true for emergencyroom visits. People living in large cities weremore likely to receive home health careand visit emergency departments, while ruralpeople were more likely to be hospitalized.

Discussion

The results derived from our study reflectthe overall pattern of health care seekingbehavior in Japan as of 2003. This is the firststudy to provide nationally representativedata. It showed that 86.2% of the respon-dents had at least one symptom while 30.7%used health service in a month. As a whole

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the results are comparable to that of thepreviously reported studies from the USA,1,2,9

although this study is based on a cohort,which is nationally representative, while thosefrom the USA drew on different sourcesproviding synthesized data. Compared withthe most recent report by Green et al.,which was representative of the whole USApopulation, people in Japan more oftenvisited their physician’s office (307 vs. 217)and hospital-based outpatient clinics (88 vs.21) than their American counterparts. Thesame was true for Japanese children interms of physician visits and emergencycare.9 However, health service uses in othercategories were very similar. It would beinteresting to know how these costlier healthservice uses are more frequent in Japancompared to that in the USA, in spite oflower per capita health care expenditure and% of GDP spent for it.

Since we did not collect data on healthoutcomes of individual persons, we cannotmake judgments on the appropriatenessof particular health care seeking behavior.There is a possibility that a significantproportion of professional medical careutilization could be in fact managed byself-care. The reverse, i.e., serious healthproblems cause by delayed physician con-sultation because of time spent by self-care,might have also occurred. Overall diseaseburden is not known from our data, becauseof the lack of data on diagnoses. In thissense, it is uncertain from the current datawhether the right patients get to the rightcare at the right time. Thus it is obvious thatfurther research incorporating data frommedical facilities is necessary.

The figures generated here in this studyare not necessarily to weigh the relativeimportance of primary, secondary, and

Fukui T, Rhaman M, Takahashi O, et al.


Table 1 Ecology of medical care in terms of type of care stratified by age, sex and area (per 1,000 persons)

Number of Office or Primary care Hospital Home UniversityCategory people with hospital physician out-patient health care Emergency medical Hospital-

at least one visit visit clinic visit visit room visit center visit izationsymptom

Number/1,000 (95% Confidence Interval)

Overall 861.7 306.6 232.3 88.3 3.5 9.8 6.3 7.2(849.7–873.0) (291.3–322.2) (218.4–246.8) (79.1–98.2) (1.8–6.0) (6.8–13.6) (4.0–9.6) (4.7–10.6)

Age

�18 872.1 402.3 335.0 82.0 3.9 20.5 4.9 2.0(850.1–891.9) (372.1–433.1) (306.1–364.8) (66.0–100.6) (1.1–10.0) (12.7–31.2) (1.6–11.4) (0.2–7.0)

�18 857.3 266.6 189.6 91.0 3.3 5.3 6.9 9.4(842.8–870.9) (249.2–284.6) (174.2–205.6) (79.8–103.0) (1.4–6.4) (2.8–9.0) (4.0–11.1) (6.0–14.0)

Sex

Male 819.3 287.0 216.3 81.7 4.9 13.5 5.5 6.8(799.7–837.7) (265.1–309.7) (196.6–237.2) (68.9–96.1) (2.1–9.7) (8.5–20.4) (2.5–10.5) (3.4–12.1)

Female 898.9 323.8 246.5 94.1 2.2 6.5 7.0 7.6(884.3–912.3) (302.5–345.6) (227.0–266.8) (81.1–108.3) (0.6–5.5) (3.4–11.3) (3.7–12.0) (4.4–12.7)

Area*

Large city 879.1 298.8 219.3 82.9 10.4 15.5 8.6 5.2(849.7–904.5) (261.8–337.9) (186.3–255.3) (61.8–108.4) (3.8–22.4) (7.1–29.3) (2.8–20.0) (1.1–15.1)

�100,000 854.4 304.5 241.9 80.6 1.2 9.6 6.0 6.0(828.1–877.7) (273.3–337.0) (213.1–272.5) (63.0–101.3) (0.03–6.7) (4.2–18.9) (2.0–14.0) (2.0–14.0)

�100,000 866.2 316.5 242.9 91.0 2.3 6.8 5.3 3.8(846.7–884.0) (291.6–342.3) (220.0–266.8) (76.1–107.7) (0.5–6.6) (3.1–12.8) (2.1–10.8) (1.2–8.8)

Rural area 848.0 297.2 213.0 96.3 2.7 10.9 6.8 16.3(820.0–873.2) (264.3–331.6) (184.0–244.4) (76.0–120.0) (0.3–9.8) (4.7–21.3) (2.2–15.8) (8.4–28.3)

*Large city: Cities with a population more than 1 million�100,000: Cities with a population between 100,000 to 1 million�100,000: Town with less than 100,000 population

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tertiary cares. Nor can this study makerecommendations for rationalization ofhealth care expenditure in different settings.This study, as mentioned above, reflects thespectrum of health care utilization, but notthe total burden of health care becausethe disease-specific data and hospitalizationdetails, which consumes the bulk of theexpenditure, remain unknown.

This study has important strengths. First,it is based on a nationally representativecohort, which is helpful in generalizing thefindings. Second, the summary findings arenested since the whole scenarios are basedon a single cohort. Third, all age groups wereincluded to gain a clear picture of Japanesesociety.

There are, however, several limitations toour study. First, data was collected duringa single month, the month of October.Seasonal variation of disease incidence

and prevalence could result in estimatesdifferent from the current data. Second, wecould not ascertain the proportion of peopleobtaining primary or subspecialty care froma physician’s office or outpatient departmentof hospitals. Nor we could estimate thefrequency of referrals to specialists.

Health care seeking behavior will certainlychange in the future due to Japan’s rapidlyaging society, the growing health awarenessof the general public, changes in theinsurance system, and abundant healthinformation. The results of this study wouldbe useful for further delineation of healthcare policy and medical education to meetthe demand and needs of people in Japan.

Acknowledgements

This research was supported by a research grant fromthe St. Luke’s Life Science Institute.

References

1. White KL, Williams TF, Greenberg BG. The ecology of medicalcare. N Engl J Med. 1961;265:885–892.

2. White K. Life and death and medicine. Sci Am. 1973;229:23–33.3. Thacker S, Greene S, Salber E. Hospitalizations in a southern

rural community: an application of the “ecology model”. Int JEpidemiol. 1977;6:55–63.

4. Green L, Fryer G, Yawn B, Lanier D, Dovey S. The ecology ofmedical care revisited. N Engl J Med. 2001;344:2021–2025.

5. Dovey S, Weitzman M, Fryer G, et al. The ecology of medicalcare for children in the United States. Pediatrics. 2003 May;111:1024–1029.

6. McWhinney I. An Introduction to Family Medicine. New York,NY: Oxford University Press; 1981.

7. White K. The ecology of medical care: origins and implicationsfor population-based healthcare research. Health Serv Res.1997;32:11–21.

8. Task Force on Building Capacity for Research in Primary Care.Putting Research into Practice. Rockville, MD: Agency for HealthCare Policy and Research; 1993.

9. Godwin M, Grzybowski S, Stewart M, et al. Need for an institute

of primary care research within the Canadian institutes of healthresearch. Can Fam Physician. 1999;45:1405–1409.

10. Anderson GF, Reinhardt UE, Hussey PS, Petrosyan V. It’s theprices, stupid: why the United States is so different from othercountries. Health Aff. 2003;22:89–105.

11. Fukui T. Health diary study of Japanese residents in GreaterBoston: variables related to high incidence of health problems.Cult Med Psychiatry. 1987;11:509–520.

12. Tonai S, Maezawa M, Kamei M, Satoh T, Fukui T. Illnessbehavior of housewives in a rural area in Japan: a health diarystudy. Cult Med Psychiatry. 1989;13:405–417.

13. Zimmerman DH, Wieder DL. The diary/diary-interview method.Urban Life. 1977;5:470–498.

14. Gibson V. An analysis of the use of diaries as a data collectionmethod. Nurse Researcher. 1995;3:66–73.

15. Bruijnzeels MA, van der Wouden JC, Foets M, Prins A, van denHeuvel WJ. Validity and accuracy of interview and diary data onchildren’s medical utilisation in The Netherlands. J EpidemiolCommunity Health. 1998 Jan;52:65–69.

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Original Article

*1 Department of International Community Health, Graduate School of Medicine, The University of Tokyo, Tokyo, JapanCorrespondence to: Masamine Jimba MD, PhD, MPH, Department of International Community Health, Graduate School of Medicine,The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.Tel: 81-3-5841-3698, Fax: 81-3-5841-3422, E-mail: [email protected]

Introduction

Since the 1950s, the World Health Organiza-tion (WHO) has emphasized school healthto show how it can contribute to improvingthe health of young people.1 As a result,much progress was seen in industrializedcountries during the 1970s and 80s.2 How-ever, the nutrition and health of school-agechildren received scant attention in develop-ing countries until the early 1990s, althoughthe percentage of school age children indeveloping countries greatly increased dur-ing this period due to successful immuniza-tion and control of diarrhoeal diseases.3,4

In the 1990s, different organizations haveinitiated more active school health pro-grammes in many developing countries. In1993, for example, the World Bank includedschool health as one component of its essen-

tial public health package for cost-effectivehealth programmes.5 Similarly, WHO regionaloffices for both Southeast Asia and theWestern Pacific have committed themselvesto reversing this trend and have publishedguidelines for school health actions.6,7 Suchcommitment has stimulated member coun-tries to initiate school health activities;however initiatives in low-income countrieshave tended to be slower to start and/or lesseffective due to poor school-related infra-structure and the absence of central educa-tion systems.

In low-income countries in East Asia andthe Pacific region, school health is importantas it is cost-effective, has a large target popu-lation, and also improves the effectiveness ofeducation in general.4 In addition, in Nepal,for example, as in several other countries inthe region where the standard of living issimilar, schools are also regarded as centres

School Health Research in Low-IncomeCountries in East Asia and the Pacific

JMAJ 48(4): 168–174, 2005

Masamine Jimba,*1 Krishna C Poudel,*1 Kalpana Poudel-Tandukar,*1 Susumu Wakai*1

AbstractAlthough the importance of school health has been emphasized in low-income countries, compara-tively little information is available. Targeting nine World Bank defined low-income countries in EastAsia and the Pacific, we found only 63 published articles pertaining to these countries in nearly fourdecades using the Medline database as a search tool. Parasite was the most common topic and thenumber of articles was rapidly increasing only in Vietnam during the period between 2000 and 2004.To encourage evidence-based school health practices, we suggest the importance of more scientificresearch in these countries.

Key words School health, Low-income countries, East Asia and the Pacific


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for overall development in rural settings sosuccessful interventions there often serve asthe most effective way to improve overalldevelopment.8 Despite such importance,nationwide school health activities havebeen uncommon and innovative health pro-moting school activities have only juststarted in countries such as Laos, Cambodiaand other low-income countries in the area.9

To ensure the effectiveness of schoolhealth activities in low-income countries, itis important to have a scientific foundationfor practice. However, the majority of schoolhealth research has been carried out in high-and middle-income countries and school-health related review articles are rarelyavailable for low-income countries. Thissituation makes it difficult for researchersand practitioners to make informed deci-sions when implementing school healthprogrammes. This paper aims to establish ascientific foundation for school health in thelow-income countries of East Asia and thePacific by using Medline to review existingliterature and extrapolate findings.

Methods

On 3 February 2005, we searched for articleson school health-related topics in the low-income countries in East Asia and the Pacificregion using Medline. In this report, low-

income countries are defined as the ninecountries out of 24 in East Asia and thePacific region identified by the World Bankin their 2005 World Development Report.10

These countries have GNI per capita equalto or less than $765. In South East Asia andthe Pacific, these countries were Cambodia,Laos/Lao PDR, Mongolia, Myanmar/Burma, North Korea, Papua New Guinea,Solomon Islands, Timor-Leste, and Vietnam.

To identify relevant school health articleswe focused on articles dealing with healthin primary or secondary schools within thetarget countries. For school health articles ingeneral, Medline has three medical subjectheading (MeSH) categories: school healthservices, school dentistry, and school nursing.These MeSH categories, however, havelimitations as other health issues outsidethose three categories may be automaticallyexcluded. To avoid such a problem, wechecked the entire database and did not justfocus on those three MeSH.

We first searched for articles written inEnglish using the keyword ‘school’ for thepublication period between 1966 and 2004.Next, we searched for articles using thenames of each low-income country in thetwo regions. Finally, we selected articles thatincluded both of these key words.

For further analysis, we printed the titlesand abstracts of all the articles we selected.

Table 1 Number of articles containing keyword ‘school’ according to country

Articles Cambodia Laos/ Mongolia Myanmar/ North Papua New Solomon Timor-Leste VietnamLao PDR Burma Korea Guinea Islands

School healtha 8 3 2 9 0 22 4 0 17

Not school healthb 1 3 4 1 0 5 1 0 5

Abroad-basedc 16 5 0 0 0 1 1 0 45

Medical/Dental 5 1 2 2 1 9 1 0 7school d

Total 30 12 8 12 1 37 7 0 74

a Studies based in primary and/or secondary schools of study countries or targeting school children of these countries. Onearticle was counted in Cambodia, Laos/Lao PDR and Vietnam therefore the total number of school health articles appearsto be 65.

b Studies based in study countries not meeting criteria of school health articles (as mentioned in a)c Studies including keyword ‘school’ and name of study countries but not based in study target-country.d Studies including keyword ‘school’ and name of study countries but taking place in schools other than primary or secondary

schools.

SCHOOL HEALTH RESEARCH IN LOW-INCOME COUNTRIES IN EAST ASIA AND THE PACIFIC


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During this process we excluded six dupli-cated articles (three substituted the keyword Laos with Lao PDR, and the otherthree, Burma with Myanmar). Then, weassessed each of the remaining articles inde-pendently. Next, we sorted them into articletypes: journal, review, or clinical trial, accord-ing to their Medline classification. In addi-tion, we grouped them into five categoriesbased on their publication year; before 1985,1985 to 1989, 1990 to 1994, 1995 to 1999, and2000 to 2004. Finally, specific topics wereidentified either by reading the abstract orfull text of each article.

Results

We identified a total of 179 articles contain-ing the key words ‘school’ and ‘each countryname’ (Cambodia�30, Laos/Lao PDR�12,Mongolia�8, Myanmar/Burma�12, NorthKorea�1, Papua New Guinea�37, SolomonIslands�7, Timor-Leste�0, and Vietnam�74) in Medline for the publication period1966 to 2004. One article was counted inCambodia, Laos/Lao PDR and Vietnam.

From the 179 articles, we excluded 116 asthey did not provide information relevant toschool health. Of these 116, 68 were basedon other countries although they containedboth key words (Table 1). The focus was thehealth of refugees from the study countriesand their children studying in schools indeveloped countries, or the health of theAmerican or Australian soldiers deployed inthe study countries for a certain period andtheir school-aged children. Another 28

articles identified the word “school” but thisrelated to medical, dental, nursing or otherschools. For example, the keyword ‘school’included in such articles was from ‘Univer-sity School of Medicine,’ ‘School of PublicHealth,’ or ‘Liverpool School of TropicalMedicine.’ Finally, 20 articles were not relatedto school health although they were con-ducted in the study countries and listed boththe keywords ‘school’ and the name of thespecific country. The keyword ‘school’ in thiscase was usually a defining reference such as,‘Mothers with some school education . . . ’ or‘Pre-school children.’

After excluding these articles 63 articlesremained relating to school health in thestudy countries: Cambodia�8, Laos/LaoPDR�3, Mongolia�2, Myanmar/Burma�9,North Korea�0, Papua New Guinea�22,Solomon Islands�4, Timor-Leste�0, andVietnam�17. One article was counted inCambodia, Laos/Lao PDR and Vietnam.

Article typeAlmost all of the school health-relatedarticles (92.1%; 58/63) were publishedas ‘Journal articles’ (Table 2). Only threewere ‘Review articles’ (one from each ofMyanmar/Burma, Papua New Guinea andVietnam). However they were not specifi-cally the reviews of school health. The topicsof the review articles were: ‘Drug abuse’(Myanmar/Burma), ‘Iron and Infection’(Papua New Guinea) and ‘Parasites’ (Viet-nam). The last two articles were ‘Clinicaltrials.’

Table 2 School health-related articles in lower-income countries of East Asia and Pacific regionaccording to article type

Article type Cambodia Laos/ Mongolia Myanmar/ Papua New Solomon VietnamLao PDR Burma Guinea Islands

Journal a 7 3 2 8 20 4 16

Review 0 0 0 1 1 0 1

Clinical trial 1 0 0 0 1 0 0

a One journal article was counted in Cambodia, Laos/Lao PDR and Vietnam therefore the total number of journal articlesappears to be 60.

Jimba M, Poudel KC, Poudel-Tandukar K, et al.


171

Table 3 School health-related articles in lower-income countries of East Asia and Pacific regionaccording to year of publication

Publication year Cambodia Laos/ Mongolia Myanmar/ Papua New Solomon VietnamLao PDR Burma Guinea Islands

Before 1985 0 0 0 2 9 1 1

1985–1989 0 0 0 2 4 0 0

1990–1994 0 0 0 1 4 1 0

1995–1999 4 0 1 2 4 2 1

2000–2004a 4 3 1 2 1 0 15

a One article published in 2003 was counted in Cambodia, Laos/Lao PDR and Vietnam therefore the total number of articlesduring 2000–2004 appears to be 26.

Table 4 School health-related articles in lower-income countries of East Asia and Pacific region according to topic

Cambodia Laos/Lao PDR Mongolia Myanmar/Burma Papua New Guinea Solomon Islands Vietnam

Topics n Topics n Topics n Topics n Topics n Topics n Topics n

Parasitea 4 Infection 1 Blindness 1 Leprosy 3 Oral health 3 Drug 1 Nutrition 4resistance

Health 1 Nutrition 1 Side-effects 1 Drug abuse 2 Parasite 3 HBV 1 Asthma 3programme of drugs & Allergy

Nutrition 1 Parasitea 1 Parasite 2 Mental health 2 Nutrition 1 Parasite a 2& Malaria

Oral health 1 Hygiene 1 Alcohol 1 Parasite 1 Allergy, 1Nutrition& Parasite

Reproductive 1 Nutrition 1 Contraception 1 Anemia 1health

Diabetes 1 Cholera 1immunization

Eye problem 1 Drug 1resistance

Genetic 1 Infection 1marker

Health 1 Injury 1promotion

Hearing 1 Oral health 1defects

HIV/AIDS 1 Population 1education

Iron & 1Infection

Lameness 1

Nutrition 1

School 1health service

Smoking 1

Value of 1children

a One article on parasite was counted in Cambodia, Laos/Lao PDR and Vietnam.



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Publication yearWe found the number of school health-related articles has been increasing gradu-ally (Table 3). A total of 13 (20.6%) articleswere published before 1985. Six articles(9.5%) were published during the periodbetween 1985 and 1989, and between 1990and 1994, respectively. The number thenincreased to 14 (22.2%) during the periodbetween 1995 and 1999. It finally reached 24(38.1%) during the last period between 2000and 2004; Vietnam, however, is the onlycountry where a rapid increase was seenduring this period.

School health article topicsAs indicated in Table 4, the school healtharticles included a variety of topics. Parasitewas the focus of 11 articles (17.5%), while 8articles (12.7%) were about nutrition, and 5(7.9%) were about oral health. Three articlesfrom Myanmar/Burma focused on Leprosywhile two others were on drug abuse. Twoarticles from Papua New Guinea focused onmental health. Asthma and allergy were thefocus of three articles from Vietnam.

Discussion

This study revealed there has been a paucityof school health research in the nine low-income countries of East Asia and thePacific region in the past four decades.Although three review papers were pub-lished relating to school health activities,they were not specifically the reviews ofschool health as we showed in the results.

Although school health activities increasedin the 1990s, they seemed to have only aminor effect on school health research in thetarget countries. Our results, therefore, maynot necessarily reflect a lack of initiatives onthe ground in these countries. For example,in our field research in Cambodia duringJune to August 2004, we found at least seveninternational NGOs were implementingschool-based health education programmes.

In addition, the Department of SchoolHealth under the Ministry of Education,Youth, and Sports has implemented sevenschool health programmes including HIV/AIDS since the late 1990s (unpublishedreport, 2004). However, only 4 papers werepublished in the 2000s in Cambodia asshown in Table 3. It suggests that a huge gapexist between practice and research intoschool health in these countries althoughsuch a gap can be also common in otherhealth activities.

Except for Vietnam, the increase in pub-lished school health articles remains similarin most of the targeted countries. We foundonly a small increase during the periodbetween 1995 and 1999 in some of thesecountries considering the size of their publichealth problems. For example, the burdenof infectious diseases in these countriesremains high11 and, as in Africa, there was anexplosion of incidences of HIV in the 1990s.Cambodia and Myanmar recorded the esti-mated national HIV prevalence rate of 2.6%and 1.2% among adults at the end of 2003.12

Despite that there has only one publishedreport of school health initiatives for HIV inthe four decades from Papua New Guinea.In contrast, school children were the targetof HIV/AIDS education in African coun-tries and reviews of a school-based approachfor HIV/AIDS in Africa have been pub-lished.13,14 Gallent and Maticka-Tyndalereviewed 11 articles of school-based HIVprevention programmes for African youth,13

and Kaaya et al.14 reviewed 47 articles report-ing sexual behaviours of school-based youngpersons in Africa.

Our study has some limitations. First, ourresearch was based only on the Medlinedatabase. Thus, school health-related papersthat were not registered with Medline wereexcluded. Second, this paper may not reflectthe school health activities in practice inthese countries as we suggested in theexample of Cambodia. Finally, some papersincluded in our search as ‘school health-related paper’ were written only for aca-



173

demic purposes and may have little impacton practice.

In conclusion, this study revealed thatschool health research is limited in the low-income countries of East Asia and thePacific region. We also hinted at a gap exist-ing between practice and research in thisregion. Such a gap may lead to non evidence-

based practices in the field and repetition ofmistakes. To avoid such a waste of resources,more researchers and programme managersare recommended to share lessons learnedby publishing their work. To support suchresearch practice we attach all the paperswe collected in this study in the Appendix.

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Papua New Guinea1. Callan VJ, Wilks J. Family size intentions and attitudes to contra-

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4. Parsons GA. An ocular survey of community school children inMadang Province. PNG Med J. 1982;25:151–154.

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175

Original Article


Preoperative TNM Staging of AdvancedGastric Cancer with Multi-Detector RowComputed Tomography

JMAJ 48(4): 175–182, 2005

Toshihiko Shinohara,*1,2 Shigekazu Ohyama,*2 Toshiharu Yamaguchi,*2 Tetsuichiro Muto,*2

Atsushi Kohno,*3 Toshihiro Ogura,*4 Yo Kato,*5 Mitsuyoshi Urashima*6

AbstractBackground Compared with early gastric cancer, advanced gastric cancer (AGC) has an aggres-sive nature and spreads easily via the lymphatic system and bloodstream. To completely removetumours or to avoid excessive treatments, a precise assessment of their spread before surgery isimportant to determine the best surgical strategy. However, the accuracy of preoperative staging ofTNM classification with computed tomography scans remains unsatisfactory. In this study, we evalu-ated the accuracy of multi-detector row computed tomography (MDCT) as a preoperative staging toolfor advanced gastric cancer.

Methods Using histological staging as the gold standard, tumour node metastases (TNM) classifi-cation was preoperatively assessed with MDCT at a slice thickness of 2.5 mm and at surgery. Thestudy included 112 consecutive patients with AGC.

Results In detecting invasion to adjacent organs (T4 category), the overall accuracy of MDCT andsurgical findings including frozen section examination was 96% and 80%, respectively (no significantdifference [NS]). In identifying the presence of lymph node metastasis (N1–N3), the overall accuracyof MDCT and surgery was 83% and 88% (NS), whereas it was 75% and 86%, respectively, indiscriminating extended lymph node metastasis (N2–N3) from minimal (N0–N1) (NS). All six livermetastases were correctly diagnosed with MDCT, although only 6 of 15 peritoneal metastases wereidentified.

Conclusions These results suggest that accuracy of MDCT with 2.5-mm slice thickness for pre-operative TNM classification may enable selection of more efficient and safer treatment strategiesbefore surgery for patients with AGC.

Key words Gastric cancer, Computed tomography, Stage, Diagnosis, Sensitivity, Specificity

*1 Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan*2 Department of Gastrointestinal Surgery, Cancer Institute Hospital, Tokyo, Japan*3 Department of Radiology, Cancer Institute Hospital, Tokyo, Japan*4 Department of Radiological Technology, Cancer Institute Hospital, Tokyo, Japan*5 Department of Pathology, Cancer Institute Hospital, Tokyo, Japan*6 Division of Clinical Research & Development, The Jikei University School of Medicine, Tokyo, JapanCorrespondence to: Mitsuyoshi Urashima MD, PhD, MPH, Division of Clinical Research & Development, The Jikei University School ofMedicine, Nishi-shimbashi 3-25-8, Minato-ku, Tokyo 105-8461, Japan.Tel: 81-3-3433-1111, Fax: 81-3-5400-1250, E-mail: [email protected]

176 JMAJ, April 2005 — Vol. 48, No. 4

Introduction

Compared with early gastric cancer, ad-vanced gastric cancer (AGC) has an ag-gressive nature and spreads easily via thelymphatic system and bloodstream. A curefor patients with AGC cannot be obtainedwithout complete removal of tumour tissuethroughout the body. To completely removetumours, a precise assessment of their spreadbefore surgery is important to determine thebest surgical strategy. However, the accuracyof preoperative staging of tumour, node,and metastasis (TNM) classification withcomputed tomography (CT) scans remainsunsatisfactory.12–17 Such inaccurate preoper-ative diagnoses may lead to inefficient dis-sections, which may increase postoperativemorbidity/mortality and decrease the re-lapse-free survival rate.1,2 More accuratepreoperative TNM staging using moderntechnologies is therefore desired.

Endoscopic ultrasonography (EUS) iscurrently considered a useful preoperativediagnostic tool.3 EUS is good at diagnosingdepth of tumour infiltration, but not at eval-uating invasion to adjacent organs, lymphnodes, and distant metastases. Moreover,the accuracy of EUS for tumour detectionin clinical practice has been reported to belower than was previously thought.4 Recently,positron emission tomography (PET) scanshave emerged, but these scans are less accu-rate for diagnosing locoregional lymph nodesthan ordinal CT scans because of a signifi-cant lack of sensitivity.5

Currently, multi-detector row computedtomography (MDCT) has been introducedas a more advanced method of spiral CT.6

Improvements in both temporal and z-axisspatial resolution with multi-slice detectorspermit higher-performance data acquisitionand higher-speed image reconstruction. Thepurpose of this study was to evaluate theclinical value of MDCT with 2.5-mm slicethickness as a tool for preoperative assess-ment of TNM classification in AGC.

Patients and Methods

PatientsBetween August 1999 and February 2002,a total of 112 consecutive patients with AGCat the Cancer Institute Hospital in Tokyo,Japan (excluding patients treated by ex-ploratory laparotomy) were prospectivelyassigned to this study. All patients under-went preoperative MDCT performed within2 weeks after endoscopy, gastrectomy plusdissection within 2 weeks after MDCT ex-amination, and histological assessment. Allpatients underwent laparotomy at the timeof surgery based on the recommendations ofthe Japanese Research Society for GastricCancer (JRSGC).7 All patients and theirfamilies were informed about the possiblerisks and benefits of the whole clinical path-way of diagnosis, including the process ofMDCT, as well as treatment for the disease,and written informed consent was obtained.

Performance of MDCTThe CT images were obtained using a fourchannel MDCT scanner (Light Speed QX/i,GE Yokokawa Medical, Tokyo, Japan). Scan-ning was done in a standard abdominal ex-amination. Scopolamine butylbromide wasadministered alone just before scanning.Neither water nor non-ionic contrast mediumwas administered perorally. In all cases,MDCT scanning was performed in the supineposition at 120 kV and 200 mA with a stan-dard algorithm and a 512�512 matrix size.A total of 100ml of non-ionic contrast medium(Iopamiron 300; iopamidol 300 mg/dl, NionSchering, Tokyo, Japan) was administeredintravenously by power injector using abiphasic technique, with 100 ml rapid bolusat a flow rate of 3 ml/s through an 18-F plas-tic catheter placed in the antecubital vein.MDCT scanning for acquisition of the firstsequence during the arterial phase wasstarted 30 s after initiating intravenous injec-tion of the contrast medium, with the secondsequence started 60 s later during the maxi-

Shinohara T, Ohyama S, Yamaguchi T, et al.

177JMAJ, April 2005 — Vol. 48, No. 4

mal portal phase. Each acquisition was per-formed during 20–30 s of a single breath-hold. The scanning range was planned start-ing from the level of the dome of thediaphragm to include the entire liver to theinferior pole of the kidneys, and in somecases, to the pelvic floor. Technical parame-ters for the MDCT examinations were asfollows: beam collimation 4�2.5 mm at apitch of 0.75 and gantry rotation time 0.8 s.Image reconstruction was performed with a2.5-mm slice thickness and interval.

MDCT assessmentThe CT images, both hardcopy axial imagesand Cine-mode display with CT equipment,were analyzed independently by two readers(T.S and O.S) preoperatively, without infor-mation on endoscopic or X-ray examinationfindings. When there was a difference ofopinion between observers, final classificationwas reached by consensus. MDCT imageswere prospectively analysed for detectabilityof the TNM classification proposed by theJRSGC.7 For tumour invasion, MDCT imageswere used to detect only direct invasion toadjacent organs, with T1–T3 category deter-mined using a combination of EUS and X-rayexaminations. Adjacent organs included thepancreas, liver, spleen, and transverse colon.These were considered to be involved whenMDCT images indicated obliteration of thefat layer between the gastric tumour and theadjacent organs. MDCT also played a role inidentifying lymph node metastases and dis-tant metastases. Regional lymph nodes wereconsidered to display metastatic involve-ment if they displayed either a diameterlarger than 8 mm and a round configura-tion or high-contrast medium enhancement(�100 HU).8–10 Regional lymph nodes of thestomach were categorized according to 16different anatomic sites and classified intothree N category compartments in accor-dance to the guidelines of the JRSGC.7

Grades in the N1, N2, and N3 categoriescomprised perigastric lymph nodes, lymphnodes along the left gastric artery, along the

common hepatic artery, around the celiacaxis and along the splenic artery, and lymphnodes in the hepatoduodenal ligament at theposterior aspect of the head of the pancreasand para-aorta. For distant metastases, anyhepatic lesion other than a cyst was regardedas potentially malignant and nodular thick-ening of the peritoneum or ascites was as-sumed to indicate peritoneal dissemination.

Statistical analysisPreoperative staging with MDCT and sur-gical staging were compared with histo-logical staging. Accuracy was first calculatedas correctly predicted stages for histologicalTNM classification divided by the numberof patients. Accuracy was further expressedas sensitivity, specificity, positive predictivevalue (PPV), and negative predictive value(NPV). Differences in sensitivity were testedusing the exact McNemar test and valuesof P�0.05 were considered significant. Allstatistical evaluations were performed usingSTATA 8.0 software (STATA Corporation,College Station, Texas, USA).

Results

Findings at surgeryThe 112 patients studied included 74 menand 38 women; mean age was 62 years (range33–86 years). The tumours were located inthe proximal (n�22), corpus (n�46), andantrum (n�44). According to Lauren’s histo-logical classification,11 intestinal and diffusetypes were seen in 33 and 79 cases, respec-tively. Total gastrectomy (n�47), partial gas-trectomy (n�58), Appleby surgery (n�1),pancreatico-duodenectomy (n�2), and leftupper abdominal evisceration (n�4) wereperformed. In 83 of 112 cases (74%), cura-tive resection was performed by removal ofthe primary gastric tumour with or withoutinvaded organs and regional lymph nodes.Splenectomy (n�40), distal pancreatectomy(n�15), partial hepatectomy (n�1), andtransverse colonectomy (n�2) were per-formed in some cases. For the remaining 29

PREOPERATIVE TNM STAGING OF ADVANCED GASTRIC CANCER WITH MULTI-DETECTOR ROW COMPUTED TOMOGRAPHY

178

patients (26%), palliative resection was per-formed due to the presence of bulky lymphnode metastases, liver metastases, and/orperitoneal dissemination. In patients treatedwith palliative surgery, regional lymph nodeswere not always resected and histologicallyanalysed. These patients were therefore notincluded in evaluation for N category. Sus-pected metastatic lymph nodes (mean, 3.3�2.2 SD) were submitted for frozen-sectionexamination using hematoxylin-eosin stain-ing during surgery. In the 83 patients whounderwent curative resection, standard D2dissection included complete dissection ofN1 and N2 category nodes (n�39), andmore radical D3 dissection included com-plete dissection of N1, N2, and N3 categorynodes (n�44).

Accuracy of MDCT in discriminatinginvasion to adjacent organsUsing histological staging as the gold stan-dard, depth of tumour invasion (T) wasassessed with MDCT or surgery (Fig. 1).Although only 6 of 112 patients displayedhistological evidence of invasion into adja-cent organs (T4), the accuracy of assessing

the tumour invasion into adjacent organswith MDCT and surgical findings was 96%(95% CI: 90% to 99%) and 80% (95% CI:88% to 95%), respectively (Table 1). Thesensitivity to detect tumour invasion intoadjacent organs was not significantly differ-ent with the McNemar test between MDCTand surgical assessment. Specificity was alsoequivalent between MDCT and surgicalfindings.

Accuracy of MDCT in lymph nodemetastasisStaging of lymph node metastases with


Fig. 1 Typical findings of invasion to adjacentorgans in MDCT

The distal gastric wall is markedly thickened by carcinoma.The outer border of the greater curvature is indistinct. Softtissue density cannot be seen infiltrating between stomachand pancreas.

Table 1 Staging of tumour invasion:MDCT vs. operative assessment;Compared with histological T category

Histology

T1-3 T4*1 Total

MDCT T1-3 103 2 105

T4 3 4 7

Operative T1-3 93 1 94

T4 13 5 18

Total 106 6 112

*1: invasion into adjacent organs

Table 2 Staging of lymph node metastases:MDCT vs. operative assessment;Compared with histological N category

Histological N category

N0 N1 N2 N3 Total

MDCT N0 18 8 3 0 29

N1 2 15 7 5 29

N2 4 7 18 8 41

N3 2 0 0 15 17

Operative N0 18 6 0 0 24

N1 4 22 6 2 34

N2 4 1 21 4 30

N3 0 1 1 22 24

Total 26 30 28 28 112


179

MDCT and surgical findings was comparedwith histological staging only for patientstreated using curative surgery (Table 2).Lymph node metastasis was found in 86patients (77%). The frequencies of nodalcategory were as follows: 26 patients (23%)with N0 category, 30 patients (27%) with N1category, 28 patients (25%) with N2 category,and 28 patients (25%) with N3 category as afinal histological study. Overall accuracy ofN0 to N3 categories was 59% (95% CI: 49%to 68%) for MDCT and 74% (95% CI: 65%to 82%) for surgical findings.

MDCT could discriminate the presence oflymph node metastases (N1 to N3) from theabsence of lymph node metastasis (N0) withdiagnostic accuracy as follows: overall 83%(95% CI: 75% to 89%); sensitivity 87%(95% CI: 78% to 93%); specificity 69%(95% CI: 48% to 86%); PPV 90% (95% CI:82% to 96%); NPV 62% (95% CI: 42% to79%). On the other hand, findings duringsurgery, including frozen section examina-tion, could discriminate the presence of lymphnode metastases with diagnostic accuracy as

follows: overall 88% (95% CI: 80 to 93%);sensitivity 93% (95% CI: 85% to 97%);specificity 69% (95% CI: 48% to 86%);PPV 91% (95% CI: 83 to 96%); NPV 75%(95% CI: 53% to 90%). The sensitivity todiscriminate the presence of lymph nodemetastases (N1 to N3) from the absence oflymph node metastasis (N0) was not sig-nificantly different with the McNemar testbetween MDCT and surgical assessment.Specificity was also equivalent betweenMDCT and surgical findings.

Next, the ability of MDCT to discriminateperitumoural lymph nodes (N0–N1 category)(Fig. 2A) from locoregional lymph nodes(N2–N3 category) (Fig. 2B) was evaluatedwith the following findings: overall 75%(95% CI: 66% to 83%); sensitivity 73%(95% CI: 60% to 84%); specificity 77%(95% CI: 64% to 87%); PPV 76% (95% CI:62% to 87%); NPV 74% (95% CI: 61% to85%). Similarly, the ability of surgical find-ings, including frozen section examination,to discriminate peritumoural lymph nodesfrom locoregional lymph nodes was evalu-


Fig. 2 Typical findings of lymph node metastasis

B: Lymph node metastasis of locoregional lymph nodes(N2–N3 category). MDCT image shows 12mm hyper-attenuating lymph node (white arrow) located along theleft gastric artery. The lymph node belongs to station No7and was identical to the metastasis-positive node in theresected specimen. Black arrow shows lymph nodealong lesser curvature; station No3.

A: Lymph node metastasis of peritumoural lymph nodes(N1 category). MDCT image shows 8mm hyperattenu-ating round lymph node along lesser curvature; StationNo3 (black arrow) that is easily distinguished from thestrongly enhanced left gastric artery (white arrow). Theresected specimen shows a 10mm metastasis-positivenode in this location.


180

ated with the following findings: overall 86%(95% CI: 80% to 93%); sensitivity 86%(95% CI: 74% to 94%); specificity 89%(95% CI: 78% to 96%); PPV 86% (95% CI:74% to 94%); NPV 86% (95% CI: 75% to94%). The sensitivity to discriminate peri-tumoural lymph nodes (N0–N1 category)from locoregional lymph nodes (N2–N3 cate-gory) was not significantly different with the


Fig. 3 Typical findings of distant metastasis

McNemar test between MDCT and surgicalassessment. Specificity was also equivalentbetween MDCT and surgical findings.

Accuracy of MDCT in discriminatingpresence of distant metastasisDistant metastases were macroscopicallyfound in 21 patients, including 6 patients withliver metastasis (Fig. 3A) and 15 patientswith peritoneal space metastasis (Fig. 3B). Inaddition, histologic findings showed cancercells in samples from the peritoneal spacein 9 patients. MDCT detected 6 of 6 livermetastases and 6 of 15 peritoneal metastases.

Discussion

The study confirmed sufficient diagnosticvalue of MDCT as a preoperative diagnostictool, since its accuracy was equivalent toassessment during surgery. Particularly,MDCT was effective in detecting invasion toadjacent organs, presence of lymph nodemetastasis and liver metastasis. Moreover,peritumoural lymph nodes (N0–N1 category)could be distinguished from locoregionallymph nodes (N2–N3 category). On the otherhand, MDCT had limitations in detecting

A: Liver metastasis. MDCT image shows a hepatic lesion;Segment 8 (black arrow). Partial hepatectomy was per-formed and was identical to the metastatic lesion.

B: Peritoneal metastasis. A 59-year-old woman with ad-vanced gastric cancer. MDCT image show the nodularthickening of the peritoneum and hydronephrosis at theright kidney. Palliative resection was performed due tothe presence of peritoneal dissemination.

Table 3 Staging of distant metastases:MDCT vs. histological M category

Metastasis to liver

H0 H1 H2 H3 Total

MDCT H0 106 0 0 0 106

H1 0 1 0 0 1

H2 0 0 2 0 2

H3 0 1 0 2 3

Operative H0 106 0 0 0 106

H1 0 2 0 0 2

H2 0 0 2 0 2

H3 0 0 0 2 2

Total 106 2 2 2 112


181JMAJ, April 2005 — Vol. 48, No. 4

peritoneal metastasis. The overall accuracywas considered as excellent compared withprevious literature.3,4,12–17

Previous studies have reported that thesensitivity for a diagnosis of invasion toadjacent organs varied, ranging from 0%to 69%.14–17 Some authors suggested thatlaparotomy has been considered the goldstandard in staging T4 category. However,surgical assessment for T4 category is not100% accurate in others’ studies, as well asours.14,18 There is a high incidence of false-positive findings due to the difficulties indistinguishing between inflammatory adhe-sions, edema, and true tumour invasion, evenduring surgery. In our study, overall accuracyof detecting invasion to adjacent organs withMDCT and with surgical findings, includingfrozen section examination, displayed goodscores: 96% and 80%, respectively. The fasteracquisition time and smaller scan collima-tion of MDCT, which allows less respiratorymiss-registration and decreased partial vol-ume effects, may have contributed to theaccuracy of the results.

Detection of involved lymph nodes repre-sents one of the most powerful predictorsof survival following curative resection forAGC.19–21 Overall accuracy to discriminatethe presence of lymph node metastases was83% for MDCT and 88% for surgical find-ings using frozen section examination. More-over, the accuracy to discriminate loco-regional lymph nodes metastases from peri-tumoural lymph nodes was 75% for MDCTand 86% for surgical findings. MDCT is thusclinically worth performing for preoperativeN category, given the importance of selectingan appropriate surgical strategy. Accordingto the Japanese gastric cancer treatmentguidelines,22 D2 dissection and sometimesmore radical D3 dissection are the preferredoptions for AGC. Extensive lymphadenec-

tomy is expected to improve survival time inpatients with resectable AGC.20 Conversely,even with radical lymphadenectomy, someof patients with locally advanced disease (ie,N2 and N3 category) cannot achieve totalresection of tumours.21 Recently, preopera-tive neoadjuvant chemotherapy in such caseshas received increasing attention.23,24 Thepreoperative demonstration of locoregionallymph nodes with MDCT may help clini-cians decide on the need for preoperativeneoadjuvant chemotherapy in patients withlocally advanced disease.

For radical resection, the most importantinformation required is whether distant meta-stases are present, as these imply that poten-tially curative resection is not feasible, orthat patients should be treated with pre-operative chemotherapy to reduce tumoursize and clear distant metastasis. Resectionshould be particularly avoided for patientswith two or more metastatic sites, as nosignificant survival advantage is conferred.25

MDCT could predict the presence or absenceof liver metastases with high sensitivity andspecificity. On the other hand, nine patientswere diagnosed with malignant ascites with-out peritoneal metastases, which was hard toassess using MDCT. Even with thinner-slicedMDCT, it was difficult to accurately detectperitoneal metastases before surgery.

In conclusion, MDCT with 2.5-mm slicethickness may raise the accuracy of pre-operative TNM classification, enabling selec-tion of more efficient and safer treatmentstrategies for patients with AGC beforesurgery.

Acknowledgements

The authors thank the Chairman and Professor, YojiYamazaki, MD, Department of Surgery, The JikeiUniversity School of Medicine, for proofreading thismanuscript.


182 JMAJ, April 2005 — Vol. 48, No. 4

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1. Ikeguchi M, Oka S, Gomyo Y, Tsujitani S, Maeta M, Kaibara N.Postoperative morbidity and mortality after gastrectomy for gas-tric carcinoma. Hepatogastroenterology. 2001;48:1517–1520.

2. Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ. Ex-tended lymph-node dissection for gastric cancer. Dutch GastricCancer Group. N Engl J Med. 1999;340:908–914.

3. Kelly S, Harris KM, Berry E, et al. A systematic review ofthe staging performance of endoscopic ultrasound in gastro-oesophageal carcinoma. Gut. 2001;49:534–539.

4. Meining A, Dittler HJ, Wolf A, et al. You get what you expect? Acritical appraisal of imaging methodology in endosonographiccancer staging. Gut. 2002;50:599–603.

5. Fukuya T, Honda H, Kaneko K, et al. Efficacy of helical CT inT-staging of gastric cancer. J Comput Assist Tomogr. 1997;21:73–81.

6. Prokop M. General principles of MDCT. Eur J Radiol. 2003; 45:S4–10.

7. Japanese Gastric Cancer Association. Japanese classificationof gastric carcinoma — 2nd English edition. Gastric Cancer.1998;1:10–24.

8. Fukuya T, Honda H, Hayashi T, Kaneko K, Tateshi Y, Ro T.Lymph-node metastases: efficacy for detection with helical CT inpatients with gastric cancer. Radiology. 1995 Dec;197(3):705–711.

9. Cho JS, Kim JK, Rho SM, Lee HY, Jeong HY, Lee CS. Pre-operative assessment of gastric carcinoma: value of two-phasedynamic CT with mechanical injection of contrast material. AJR.1994;163:69–75.

10. Lee DH, Seo TS, Ko YT. Spiral CT of the gastric carcinoma:staging and enhancement pattern. Clin Imaging. 2001;25(1):32–37.

11. Lauren P. The two histological main types of gastric carcinoma:diffuse and so-called intestinal type carcinoma: an attempt athistoclinical classification. Acta Pathol Microbiol Scand. 1965;64:31–49.

12. Moss AA, Schnyder P, Marks W, Margulis AR. Gastric adeno-carcinoma: a comparison of the accuracy and economics ofstaging by computed tomography and surgery. Gastroenterol-ogy. 1981;71:413–417.

13. Dehn TC, Reznek RH, Nockler IB, White FE. The pre-operativeassessment of advanced gastric cancer by computed tomog-

raphy. Br J Surg. 1984;71:413–417.14. Botet JF, Lightdale CJ, Zauber AG, et al. Preoperative staging of

gastric cancer: comparison of endoscopic US and dynamic CT.Radiology. 1991;181:426–432.

15. Sussman SK, Halvorsen RA Jr, Illescas FF, et al. Gastric adeno-carcinoma: CT versus surgical staging. Radiology. 1988;167:335–340.

16. Minami M, Kawauchi N, Itai Y, Niki T, Sasaki Y. Gastric tumors:Radiologic-pathologic correlation and accuracy of T staging withdynamic CT. Radiology. 1992;185:173–178.

17. Davies J, Chalmers AG, Sue-Ling HM, et al. Spiral computedtomography and operative staging of gastric carcinoma: a com-parison with histopathological staging. Gut. 1997;41:314–319.

18. Paramo JC, Gomez G. Dynamic CT in the preoperative evalua-tion of patients with gastric cancer: correlation with surgical find-ings and pathology. Ann Surg Oncol. 1999;6:379–384.

19. Klein Kranenbarg E, Hermans J, van Krieken JH, van de VeldeCJ. Evaluation of the 5th edition of the TNM classification forgastric cancer: improved prognostic value. Br J Cancer.2001;84:64–71.

20. Maehara Y, Kakeji Y, Oda S, Takahashi I, Akazawa K,Sugimachi K. Time trends of surgical treatment and the prog-nosis for Japanese patients with gastric cancer. Br J Cancer.2000;83(8):986–991.

21. Maruyama K, Gunven P, Okabayashi K, Sasako M, Kinoshita T.Lymph node metastases of gastric cancer. General pattern in1931 patients. Ann Surg. 1989;210:596–602.

22. Nakajima T. Gastric cancer treatment guidelines in Japan. Gas-tric Cancer. 2002;5:1–5.

23. Yamao T. Rationale for neoadjuvant chemotherapy for advancedgastric cancer. In: Nakajima T, Yamaguchi T, editors. Multi-modality therapy for gastric cancer. New York Heidelberg BerlinTokyo: Springer Verlog. 1999;9:115–121.

24. Fink U, Schuhmacher C, Stein HJ, Busch R, Feussner H, DittlerHJ. Preoperative chemotherapy for stage III-IV gastric carci-noma: feasibility, response and outcome after complete resec-tion. Br J Surg. 1995;82(9):1248–1252.

25. Hartgrink HH, Putter H, Klein Kranenbarg E, Bonenkamp JJ, vande Velde CJ. Value of palliative resection in gastric cancer. Br JSurg. 2002;89:1438–1443.


183

Review Article


Epidemiology of Kawasaki Disease in Japan

JMAJ 48(4): 183–193, 2005

Ritei Uehara,*1 Yosikazu Nakamura,*1 Hiroshi Yanagawa*2

AbstractKawasaki disease was first described by Dr. Tomisaku Kawasaki in 1967. This disease is an acute,febrile illness primarily affecting infants and children younger than 4 years old. Although this diseaseis characterized by systemic vasculitis, the etiology is still unknown. To clarify the epidemiologicfeatures of Kawasaki disease, nationwide surveys have been conducted since 1970. Approximately186,000 patients were identified in 17 surveys completed prior to 2002 based on similar diagnosticcriteria. From the results of these surveys, not only the disease distributions, such as annual or monthlychanges and geographical shift, but also the clinical characteristics of this disease were clarified.Epidemiologic studies of this disease in Japan provide useful results for physicians and researchersaround the world who are involved in treating Kawasaki disease.

Key words Kawasaki disease, Epidemiology, Nationwide survey, Diagnostic criteria, Distribution,Prognosis

Introduction

Dr. Tomisaku Kawasaki first encountereda 4-year-boy with the unique clinical char-acteristics of muco-cutaneous lymph nodesyndrome (MCLS) in 1961 and described afurther 50 cases that had similar character-istics to the first case in the journal Arerugiin 1967.1 Now more commonly known asKawasaki disease, MCLS is acute self-limitedvasculitis that occurs predominantly in infantsand children younger than 4 years old. Thisdisease is characterized by fever, bilateralnonexudative conjunctivitis, erythema of thelips and oral cavity, changes in the extrem-ities, polymorphous exanthema, and non-purulent cervical lymphadenopathy. Cardiacsequelae, such as coronary arterial dilatation

and aneurysms, are the most important issuesin this disease. The etiology is still unknown.

To clarify the characteristics of this dis-ease, epidemiologists have contributed tothe research since 1970. In this review, weintroduce the results from epidemiologicstudies conducted in Japan, predominantlyfrom nationwide surveys of Kawasaki disease.

The Diagnostic Guidelines andNationwide Epidemiologic Surveysof Kawasaki Disease

After publication of the case series onKawasaki disease by Dr. Kawasaki, a Min-istry of Health and Welfare medical re-search grant in fiscal year 1970 enabled for-mation of the Kawasaki Disease ResearchCommittee. The group’s first project was a

*1 Department of Public Health, Jichi Medical School, Tochigi, Japan*2 Saitama Prefectural University, Saitama, JapanCorrespondence to: Ritei Uehara MD, PhD, Department of Public Health, Jichi Medical School, 3311-1 Yakushiji, Minamikawachi,Tochigi 329-0498, Japan. Tel: 81-285-58-7338, Fax: 81-285-44-7217, E-mail: [email protected]

184 JMAJ, April 2005 — Vol. 48, No. 4

nationwide survey of the disease, utilizingthe “Diagnostic Guidelines of KawasakiDisease (first edition)” compiled prior to thesurvey so that uniform and clearly definedcriteria would be available to the manypediatricians cooperating in the case collec-tion effort. This principle of epidemiologicsurveys is one of the most important proce-dures to researchers in the field.

Kawasaki disease was not widely knownamong pediatricians at the time. For a start,

the survey aimed to ensure that reportedcases were identified on the basis of uniformcriteria. In addition, the objective was tomake the disease’s existence more widelyknown.

The diagnostic guidelines succinctly listKawasaki disease’s main symptoms togetherwith relevant information. For easy under-standing, color photographs on the back pageillustrate the disease’s main manifestations.Because the descriptions of the main symp-

Uehara R, Nakamura Y, Yanagawa H

Table 1 The fifth revised edition of the Diagnostic GuidelinesThis is a disease of unknown etiology affecting most frequently infants and young children under 5 years of age.The symptoms can be classified into two categories, principal symptoms and other significant symptoms or findings.

A. PRINCIPAL SYMPTOMS

1. Fever persisting 5 days or more (inclusive of those cases in which the fever has subsided before the 5th day inresponse to therapy)

2. Bilateral conjunctival congestion3. Changes to lips and oral cavity: Reddening of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosa4. Polymorphous exanthema5. Changes to peripheral extremities:

[Initial stage]: Reddening of palms and soles, indurative edema[Convalescent stage]: Membranous desquamation from fingertips

6. Acute nonpurulent cervical lymphadenopathyAt least five items of 1–6 should be satisfied for diagnosis of Kawasaki disease. However, patients with four items ofthe principal symptoms can be diagnosed as having Kawasaki disease when coronary aneurysm or dilatation isrecognized by two-dimensional echocardiography or coronary angiography.

B. OTHER SIGNIFICANT SYMPTOMS OR FINDINGS

The following symptoms and findings should be considered in the clinical evaluation of suspected patients.1. Cardiovascular: Auscultation (heart murmur, gallop rhythm, distant heart sounds), ECG changes (prolonged PR/QT

intervals, abnormal Q wave, low-voltage, ST-T changes, arrhythmias), chest X-ray findings (cardiomegaly), 2-D echofindings (pericardial effusion, coronary aneurysms), aneurysm of peripheral arteries other than coronary (axillary etc.),angina pectoris or myocardial infarction

2. GI tract: Diarrhea, vomiting, abdominal pain, hydrops of gall bladder, paralytic ileus, mild jaundice, slight increase ofserum transaminase

3. Blood: Leukocytosis with shift to the left, thrombocytosis, increased ESR, positive CRP, hypoalbuminemia, increased�2-globulin, slight decrease in erythrocyte and hemoglobin levels

4. Urine: Proteinuria, increase of leukocytes in urine sediment5. Skin: Redness and crust at the site of BCG inoculation, small pustules, transverse furrows of the finger nails6. Respiratory: Cough, rhinorrhea, abnormal shadow on chest X-ray7. Joint: Pain, swelling8. Neurological: CSF pleocytosis, convulsions, unconsciousness, facial palsy, paralysis of the extremities

REMARKS :

1. For item 5 under principal symptoms, the convalescent stage is considered important.2. Non-purulent cervical lymphadenopathy is less frequently encountered (approximately 65%) than other principal

symptoms during the acute phase.3. Male: Female ratio: 1.3–1.5 : 1, patients under 5 years of age: 80–85%, fatality rate: 0.1%4. Recurrence rate: 2–3%, proportion of siblings cases: 1–2%5. Approximately 10 percent of the total cases do not fulfill five of the six principal symptoms, in which other diseases can

be excluded and Kawasaki disease is suspected. In some of these patients coronary artery aneurysms (includingso-called coronary artery ectasia) have been confirmed.

185JMAJ, April 2005 — Vol. 48, No. 4

toms in the diagnostic guide follow thosegiven in the original edition, even over fourrevisions over the past 30 years, the gen-eral construct of patients’ characteristics col-lected in the surveys has varied little. Thefifth revised edition of the guidelines hasbeen available since February 2002 (Table 1).Approximately 186,000 patients reported in17 surveys over the past 30 years (1970–2002) were diagnosed using basically thesame criteria. Therefore, comparability ofthe epidemiologic features of the disease inthese data sets is well guaranteed.

The Results of the Past 17Nationwide Surveys onKawasaki Disease

Since the first nationwide survey of Kawasakidisease in 1970, 17 surveys have been con-ducted and data on approximately 186,000patients (covering a 32-year period endingon December 31, 2002) have been collected.In each survey, the targets were hospitalswith 100 or more beds and a pediatric depart-ment, which were selected from medicalfacilities located throughout the country.Starting from the 11th survey, those hospitals

specializing in pediatrics and having lessthan 100 beds were also included. For theselection of these hospitals, the latest editionof “Listing of Hospitals” (compiled by theMinistry of Health and Welfare and pub-lished by Igaku Shoin) that was available atthat time was used.

These nationwide surveys for Kawasakidisease have been conducted biannually forthe past 32 years since 1970 (Table 2).Throughout this period, patients’ data werecollected based on generally uniform diag-nostic criteria. Although the criteria wasupdated 5 times, the basic clinical findingsdescribed in them remained unchanged,enabling annual comparisons of the data.The surveys were conducted throughout thecountry, targeting all the facilities with pedi-atric departments among major hospitalsequipped with 100 or more beds. It is plau-sible to assume that this is the most reliabledata available exhibiting epidemiologic fea-tures of Kawasaki disease in Japan.

This section focuses on changes in theepidemiologic profile of Kawasaki diseasethat took place during these 32 years andwas noted in the 17 nationwide surveysdescribed above.2–28

EPIDEMIOLOGY OF KAWASAKI DISEASE IN JAPAN

Table 2 Survey years and number of hospitals in 17 nationwide epidemiologic surveys in Japan

Survey number Covered years Number of hospitals

1 –1969 1,4582 1970–72 1,4523 1973–74 (June) 1,6384 1974 (July)–76 1,6835 1977–78 1,6886 1979–80 1,6977 1981–82 (June) 1,9408 1982 (July)–84 2,3159 1985–86 2,379

10 1987–88 2,25011 1989–90 2,68612 1991–92 2,65213 1993–94 2,64014 1995–96 2,62715 1997–98 2,66316 1999–2000 2,61917 2001–02 2,413

186

(1) Annual changesAnnual changes in the number of patients bysex are shown in Fig. 1. The total number ofpatients was reported to be 186,069 (107,876males and 78,193 females).

Between 1965 and 1986, the number ofpatients mounted steadily: during this time,sudden outbreaks were noted 3 times, form-ing high peaks when compared with thestatistics of the year before or after (1979,6,867 patients with an incidence rate of 78.0,2.1 times the previous year; 1982, 15,519patients with an incidence rate of 196.1,2.5 times the year before; and 1986, 12,847,

with an incidence rate of 176.8, 1.7 timesthe preceding year). Between 1987 and 1998,the number of patients increased graduallywithin a range of 5,000 to 7,000. In 1999,it exceeded 7,000; and in 2000, 8,000. In thelast two years, this rising trend appears to becontinuing. The sex ratio has been 1.38,according to the surveys.

In examining the annual changes in inci-dence rate (Fig. 2), the continued drop in thepopulation between the ages of 0 to 4 yearsmust be considered, making the rising trendin incidence rate since 1987 appear moredrastic than suggested by the curve repre-senting the number of patients. Comparedwith a rate of 73.8 in 1987 (the year imme-diately after the third outbreak), those for1998, 2000, and 2002 were 111.5 (1.5 times),141.1 (1.9 times), and 151.2 (2.0 times),respectively.

Due to a lack of knowledge of Kawasakidisease among pediatricians, the rate ofresponses from the target facilities was lowuntil around 1978, when the number ofpatients involved in the annual fluctuationsperhaps reflected a change in attitude by thepediatricians towards the disease, com-pounding the actual increase in incidence.


Fig. 2 The incidence rates of Kawasaki disease by sex

per 100,000�5 years old250

200

150

100

50

0

1964

male

female

19661968

19701972

19741976

19781980

19821984

19861988

19901992

19941996

19982000

2002

calendar year

Fig. 1 The number of patients with Kawasaki disease by sex


19641966196819701972197419761978198019821984198619881990199219941996199820002002

0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000

No. of patients

male female

187

However, triggered by the nationwide epi-demic witnessed in 1979, interest in Kawasakidisease among pediatricians intensified. Sincethe 6th nationwide survey, the response ratehas always exceeded 60%; therefore it isbelieved that since this time, the survey datafaithfully reflected the true annual changesin the incidence of this disease. Since 1970, theresponse rate has been maintained between60 to 70%. However, compared with ordi-nary hospitals, the response rate of majorhospitals caring for a large number of patientsis higher; 29 and most of the patients whoinitially visited hospitals equipped with lessthan 100 beds (not targeted in the currentsurveys) are eventually referred to thosewith a bed capacity of more than 100.30 Inview of these facts, one can safely assumethat since 1979 the surveys encompass morethan 80% of the patients in this country.

(2) Monthly changesWhen incidence during the last 10 years isexamined in quarterly periods (January toMarch, April through June, July throughSeptember, and October through Decem-ber), the incidence is found to be lowerwithout exception in the fourth quarter forboth sexes.

(3) Geographical shift in epidemiologictrends

The 16th nationwide survey recorded morethan 7,000 patients in 1999. In 2000, thenumber exceeded 8,000, which surpassedthe 6,867 patients of 1979 (the year of thefirst epidemic). The geographic difference inincidence was examined for 1999 and 2000:in September and October of 1999, the inci-dence was slightly higher in Kyushu; inNovember and December, the area of highincidence spread and a high incidence wasnoted even on the Japan Sea side of theTohoku region. In January and February of2000, the high incidence, which originallyoccurred mainly in the western part of Japan,spread gradually throughout the country,continuing to spread in March–April, May–

June, and July–August. Areas of high inci-dence rate remained in part of Tohoku inSeptember and October and on the PacificOcean side of the country in November andDecember.

The initial increase in the number ofpatients occurred in specific areas but spreadthroughout the country within 3 to 6 months.Similar epidemiologic patterns have beenobserved overseas,31–33 supporting the hypo-thesis that a viral infection is involved in thecause of Kawasaki disease. No abnormalincidence rates that may qualify as an epi-demic were noted between 1987 and 2000. In1999 and 2000, the observed trend thenchanged: the incidence rate rose slightly (in2000, the incidence exceeded that of 1979).Like the pattern in past epidemics, the inci-dence during this period shifted from onegeographic area to another. However, unlikethe past pattern, the epidemic had not evi-dently ended at the time of the conclusion ofthis study.

(4) Age distributionWith hardly any exceptions since the 1stnationwide survey, the age-specific incidencerate was expressed by a single-peak curve(the peak representing 0 to 11-month-oldinfants): under one year, 27.8% (males,28.8%; females, 26.5%) and under 4, 81.7%(males, 82.3%; females, 81.0%). Fig. 3 showsthe sex and age specific incidence rates com-


Fig. 3 The incidence rates of Kawasaki disease bysex and age (average from 1991 through 1996)

per 100,000 per year

250

200

150

100

50

0

age (year)

male

female

0 1 2 3 4 5 6 7 8 9 10 11 12


188

puted from the means of each year from1991–1996.

The results of the nationwide surveysexhibit the following patterns: the incidencerate for Kawasaki disease is markedly lowfrom birth to 2 months of age, rises suddenlybetween 3 and 5 months, peaks between 6and 8 months and 9 and 11 months, andundergoes a sudden decline thereafter. Toexplain this pattern, the following scenario iscited: micro-organism(s) of unknown patho-genicity commonly exist in the living spaceof children; and the morbidity among themrises, corresponding to the time when thematernally derived immunity level declinesafter birth.

(5) Incidence among siblings andrecurrences

Questions on family history and recurrenceswere added in 1977.

The familial incidence has always beenaround 1%, which is more than 10 times thelevel expected from the general incidence.The possibility of a risk from common expo-sure, familial transmission, and common hostfactors should be considered.34 The propor-tion of Kawasaki disease patients whoseparents suffered from the same disease was0.2% in the 16th survey. When comparedwith parents in the general population, theprobability of a history of Kawasaki diseasewas significantly higher in those parentswhose children had the same disease. Thissuggests that a genetic predisposition toKawasaki disease may be implicated in itsoccurrence.35

Recurrences were observed in approxi-mately 3%, a rate that varied little overthe years. There were some patients whosuffered from the disease 3 or more times.The sex ratio for recurrence was 1.6 (the riskof a recurrence for patients who had ahistory of Kawasaki disease was 1.1; thusno difference was observed vis-à-vis sex).Fatalities were high among those suffering arecurrence [0.9%; 3 times higher than therate for all cases (0.3%)]. A positive correla-

tion was observed between the recurrencerate and morbidity for season and geo-graphic area. The incidence among siblingswas high in those who suffered a recur-rence — 3 times higher than the rate for allcases studied. The recurrence rate during anepidemic was 950 in every 100,000 patients,which is 6 times higher than the morbidityrate observed among 0–4 year olds duringthe same period (150 in every 100,000).36

(6) Cardiac sequelaeQuestions on cardiac sequelae were addedin 1983. Until 1996, the question on theincidence of cardiac sequelae was posed ina “yes” or “no” format, while the sequelaewere clearly defined in the survey form as“recognition of dilation of the coronaryartery (including aneurysms), coronary arterystenosis (including obstruction), and myo-cardial infarction or valvular lesions, alldeveloping at least one month after onset.”On the other hand, since 1997 when the 15thnationwide survey was conducted, the ques-tion on the sequelae was subdivided into twoparts, acute stage cardiac dysfunction (withinone month of onset) and cardiac sequelae(occurring at least one month after onset).One should note that some of the symptomscorresponding to acute stage cardiac dys-function defined above might have beenreported as sequelae in the surveys that wereconducted up to 1996.

The percentage for those with cardiacsequelae was 16.7% in 1983, which graduallydecreased since then to 12.1% (1996), 5.1%(1997), and 5.7% (2000), showing a clear-cutdrop between 1996 and 1997. One reasonfor this phenomenon may be the deviationcaused by having created a separate ques-tion for acute stage cardiac dysfunction; butit is also due to the tendency for reductionsin the development of this dysfunction.

According to the 17th survey, 16.2% ofreported patients (18.6% male, 13.0% female)had acute cardiac disorders, the rate beinghigh among infants less than 6 months oldand older infants. On the other hand, 5.0%



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(6.9% male, 3.8% female) of patients hadcardiac sequelae, which is a third of the pro-portion of acute cardiac disorders for bothmales and females. In terms of age, the pro-portions were higher in infants of less than 6months old and in older children, thus form-ing a gentle U-shaped curve dipping at the2 year-old mark. The proportion of patientswith acute cardiac dysfunctions included:12.97% for coronary artery dilatation, 1.96%for aneurysms, 1.58% for valvular lesions,0.27% for giant aneurysms, 0.05% for coro-nary stenosis, and 0.02% for myocardialinfarctions. The proportion of patients withcardiac sequelae were: 3.13% for coronaryartery dilatation, 1.36% for aneurysms, 0.29%for giant aneurysms, 0.31% for valvularlesions, 0.06% for stenosis, and 0.04% formyocardial infarctions.

For the factors contributing to the develop-ment of cardiac sequelae, the following havebeen cited: male sex; age under 6 months orover 7 years; a recurrence of Kawasaki dis-ease; and a low level of serum albumin.37–40

To clarify the etiological factors for thedevelopment of giant aneurysms, a case-control study was conducted, in which theclinical findings up to 20 days after onsetwere compared. Subsequently, the followingwere suspected to be risk factors for thedevelopment of a giant aneurysm: a lowserum potassium level at admission, lowminimum platelet count, a high maximumplatelet count, high level of maximum C-reactive protein, low minimum hematocritlevel, minimum hemoglobin level, maximumwhite blood cell count, and late developmentof minimum albumin level.41 The incidenceof cardiac sequelae was high among recur-rent cases, irrespective of the association ofcardiac sequelae with the first affliction.42

(7) MortalityUntil 1974, the case-fatality rate exceeded1%, which gradually decreased and remainedaround 0.1% in the 1990s. The mean for allthe surveys is 0.25%. A reduction in fatalityrate was evident, which is probably due to

the efficacy of gamma-globulin therapy anda relative drop in incidence due to the dis-semination of information on this diseaseamong pediatricians and the resultant inclu-sion of many milder cases in the reports.

Yashiro, et al. observed the 449 fatal casesreported by 1998 (which include the fatalcases plus 40 patients who were alive atthe time of the survey but whose death wasconfirmed later).43 The results showed a fatal-ity rate of 0.29% (and 0.63%, a particularlyhigh rate among children under one year ofage); the male/female ratio was 1.5; exten-sive use of gamma-globulin treatment servedto reduce the fatality rate markedly; and11.5% of the patients died one year after theinitial diagnosis. Nakamura, et al. conducteda follow-up study on 8,417 patients, eachdiagnosed in one of 52 hospitals during aperiod between July 1982 and December1992.44–46 They followed-up on these patientsuntil the end of 1999 and reported that thestandardized mortality ratio increased dur-ing the 2-month acute stage after the firstdiagnosis; no increase was observed afterthe acute stage; and the standardized mor-tality rate among those with cardiac sequelaewas high.

(8) Treatment in the acute stage ofKawasaki disease

The use of therapeutic agents—steroid prep-arations (1974–1990), antibiotics (1974–1990),aspirin (1974–1990), and gamma-globulin(1974–1990)—was investigated. Steroid prep-arations were used for 53% of cases in 1975but fell rapidly to 6.3% in 1983, then werealmost completely abandoned in the 1990s.Antibiotics were used for 92% of cases in1974 but their administration was graduallyreduced to a 70% level in the 1990s. Aspirinuse was around 90% throughout the entiresurvey period. Gamma-globulin was firstdispensed around 1983, exceeded the useof steroids that same year, and has beenprescribed for more than 80% of cases since1992. Its use is now maintained at around85%.



190

The dosage of gamma-globulin used fortreatment appears to have increased annu-ally. As shown in Fig. 4, the common dosagewas 1,000 mg/kg until around 1995 but adosage of 2,000 mg/kg suddenly becamedominant and was applied to more than 50%of the patients in 1998. For the gamma-globulin regimen applied to prevent cardiacsequelae, the following have been cited:initiation soon after onset and administra-tion of a sufficient dosage (2,000 mg/kg),which may be given in massive dosages overa short period, such as 2,000 mg/kg for 1 dayor 1,000 mg/kg for 2 days.47,48

Other Epidemiologic Studies onKawasaki Disease in Japan

(1) Descriptive epidemiology of the patients1) Geographic distributionThe municipalities neighboring those withhigh incidence rates also indicated highrates.49,50 The clustering pattern was foundin many regions and was also prevalent onthe prefectural level, indicating that the pre-fectures with high incidence rates tended tocluster. The clustering of regions with highincidence rate is probably related to publictransportation channels and the movementof people. Simultaneous occurrences on anisolated island and in housing complexeswere reported. With regard to the contact

between patients, there were instances ofspecific kindergartens where clustering wasevident and others where no such patternwas recognized.51–53 In the 1-year, 4-monthperiod between March 1979 and July 1980,13 individuals living in a new residential area(population aged 9 or under: 6,300) in thesuburbs of Yokohama City contracted thedisease. They resided within a 2 km radius ofeach other; however, Takahashi, et al. foundno evident contact among these patients.These patients became affected betweenNovember 1979 and July 1980, later than thetime when most patients developed the ill-ness during the nationwide outbreak (betweenMarch and May 1979).54

2) Occurrences among siblingsNanri, et al. examined the repeated occur-rence of the disease (amounting to 27 timesaltogether) in 12 recurrent cases.55 The out-lines of these cases are as follows: (1) inmonozygotic twins suffering the disease fourtimes, the first child occurred when he was 10months old and the second child when he was10 months old (with the interval betweenthe two being 9 days). For the second occur-rence, the second child was 1 year 10 monthsold and the first child was 1 year 9 monthsold (the interval being 18 days); (2) for recur-rences in dizygotic twins, the first incidenceoccurred when the first and second children(a boy and a girl) were 10 months old (thedisease developed on the same day), andthe second incidence occurred when the boywas 2-years 4 months old and his sisterdeveloped aphthous stomatitis 11 days later;and (3) in a brother-sister case, the brotheroccurred 3 times. A case of Kawasaki diseasedeveloping simultaneously in monozygotictwins living in a mountainous region ofKumamoto Prefecture was reported.56 Thearea offered little contact with people in thesurrounding areas. Prior to the developmentof the disease, 4 older siblings (starting withthe oldest) had exhibited cold-like symp-toms with a fever. In research conducted byKumamoto University, it was reported thatsymptoms occurred 8 times among 3 siblings.


Fig. 4 The proportion of patients with Kawasakidisease treated with gamma globulin bytotal dosage

%

60

50

40

30

20

10

0

calendar year

1991

2,000mg/kg

1,000mg/kg

1,100–1,900mg/kg

1992 1993 1994 1995 1996 1997 1998 1999 2000


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A survey conducted by Tsuchiura Kyodo Gen-eral Hospital introduced cases of Kawasakidisease occurring a total of 8 times among3 siblings. The symptoms were first noted inthe oldest brother who was going to kinder-garten, followed by two younger sisterswithin one week (with onsets one day apartamong the sisters). The number of absenteesfrom the kindergarten and the statistics onthe patients visiting local clinics around thesame time offered no information to supporta marked increase in absenteeism.3) Similarity to other major infectious

diseasesAmong the infectious diseases reported inthe Ministry of Health and Welfare Infec-tious Disease Surveillance System, 13 dis-eases that occur mainly in young childrenwere selected. The number of cases reportedper fixed point was compared against cases ofKawasaki disease as reported in the Nation-wide Surveys for the same period. Infectionssuch as rubella and exanthema subitumshowed a curve similar to that of Kawasakidisease. The peak for hemolytic strepto-coccal infection, which is the focus of atten-tion as a possible cause of Kawasaki disease,was seen to occur between the autumn andwinter.57

4) Cases occurring in hospitalsKato, et al. in Kurume University reportedthat 54 days after a patient with Kawasakidisease was admitted to the hospital, anotherpatient who had been admitted in the sameroom (with congenital laryngomalacia) devel-oped Kawasaki disease. Both patients hadcoronary artery aneurysms.58 Other casesinvolving inpatients are rare.

(2) Analysis of the etiological factorsTo clarify the possible etiological factors ofKawasaki disease, Kubota, et al. in 1975 con-ducted a case-control study on mothers ofpatients with Kawasaki disease, with thecooperation of 128 facilities in 43 munici-palities across the country.59 In 295 pairs ofpatients and the control (patients’ motherselected from her acquaintances controls


who had children of the same sex and similarage), 233 attributes were compared, includ-ing home environment, medical history, tend-ency to contract illness, family history, his-tory of inoculations, nutrition during infancy,type of everyday goods used, pregnancycomplications, and usage of certain medica-tions. The results can be summarized asfollows: a tendency for the patients’ parentsto contract tonsillitis, stomatitis, eczema, andconjunctivitis; higher incidences of stoma-titis, allergic rhinitis, and chapped lips amongthe patients and their siblings; no differencein the history of inoculations in comparisonwith the controls; a slightly higher frequencyin early disruption of breast feeding andswitching to bottle-feeding immediately orshortly after birth; and a slightly higher inci-dence of tonsillitis or a more frequent use ofantibiotics or anti-allergy drugs when themothers were pregnant. There was no differ-ence between the two groups when the hous-ing where they resided or other environ-mental conditions were compared (e.g., typeand age of the building, number of floors,type of air conditioning, and presence ofpests, animals, and pets). The mothers’ specu-lations on the cause of the disease included:bathing in the sea or a swimming pool, play-ing with water, traveling, going for a ride,and enrolling in kindergarten. Kishimoto,et al. conducted an interview with patientsadmitted to 3 city hospitals and the controlswho were matched to the patients in sex andage.60 The results showed that there was nodifference in the history of inoculations; thepatients’ families were more vulnerable tocolds; and there was a tendency among thepatients’ mothers not to give colostrum inearly infancy and to rely on bottle feeding.

Conclusions

Kawasaki disease was discovered in Japanand is now known around the world. A lot ofevidence about this disease, especially thatrelated to epidemiology, has been sent fromJapan to the world. Epidemiologic studies


192 JMAJ, April 2005 — Vol. 48, No. 4

of this disease not only provide clarifyingexplanations of distribution, but also basicdata that are useful for an understanding

of etiological and prognostic factors, and,thereby greatly contribute to furtheringfuture research.

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3. Shigematsu I, Yanagawa H. Kawasaki disease. Nippon KoshuEisei Zasshi. 1975;22:306–312. (in Japanese)

4. Yanagawa H. Kawasaki disease. Koshu Eisei Joho. 1975;5(12):22–29. (in Japanese)

5. Yanagawa H. Epidemiology of Kawasaki disease (muco-cutaneous lymph node syndrome). Nippon Rinsho. 1976;34:275–283. (in Japanese)

6. Japanese Kawasaki Disease Research Committee. MCLS(Kawasaki disease) in 1977 and 1978: a prompt report of resultsof the 5th nationwide survey. Shonika. 1979;20:755–757. (inJapanese)

7. Japanese Kawasaki Disease Research Committee. An outbreakof Kawasaki disease (MCLS) in 1979: preliminary report of thesixth nationwide survey. Shonika. 1981;22:53–58. (in Japanese)

8. Japanese Kawasaki Disease Research Committee. Recent trendof MCLS (Kawasaki disease) in Japan: provisional results of the7th nationwide survey. Shonika. 1983;24:53–58 (in Japanese).

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10. Japanese Kawasaki Disease Research Committee. Results ofthe 9th nationwide survey on Kawasaki disease (1985–1986).Shonika. 1987;28:1059–1066. (in Japanese)

11. Japanese Kawasaki Disease Research Committee. The 10thnationwide survey on Kawasaki disease in Japan. Shonika.1990;31:569–576. (in Japanese)

12. Japanese Kawasaki Disease Research Committee. Results ofthe 11th nationwide epidemiological survey of Kawasaki disease.Shonika. 1992;33:309–316. (in Japanese)



15. Japanese Kawasaki Disease Research Committee. Results ofthe 14th nationwide survey of Kawasaki disease in Japan.Shonika Shinryo. 1998;61:406–420. (in Japanese)

16. Japanese Kawasaki Disease Research Committee. Results ofthe 15th nationwide survey on Kawasaki disease. ShonikaShinryo. 2000;63:121–132. (in Japanese)

17. Yanagawa H, Nakamura Y, Yashiro M. Results of the 16th nation-wide survey of Kawasaki disease. Shonika Shinryo. 2002;65:332–342. (in Japanese)

18. Nakamura Y, Yashiro M, Uehara R, Yanagawa H. Results of the17th nationwide survey of Kawasaki disease. Shonika Shinryo.2004;67:313–323. (in Japanese)

19. Yanagawa H. The results of nationwide surveys. In ShigematsuI, Yanagawa H, Kawasaki T, ed. Kawasaki disease: epidemio-logical data book. Tokyo: Soft Science Publications; 1986:37–51. (in Japanese)

20. Yanagawa H, Yashiro M, Fujita Y. Nationwide surveys ofKawasaki disease. In Kawasaki T, Shigematsu I, Hamashima Y,Yanagawa H, Kato H ed. Kawasaki disease. Tokyo: Nankodo;1988:18–31. (in Japanese)

21. Kawasaki T, Kosaki F, Okawa S, et al. A new infantile acutefebrile mucocutaneous lymph node syndrome (MLNS) prevailingin Japan. Pediatrics. 1974;54:271–276.

22. Yanagawa H, Kawasaki T, Shigematsu I. Nationwide survey onKawasaki disease in Japan. Pediatrics. 1987;80:58–62.

23. Yanagawa H, Nakamura Y, Yashiro M, et al. A nationwide surveyof Kawasaki disease in 1985-1986 in Japan. J Infect Dis. 1988;158:1296–1301.

24. Yanagawa H, Yashiro M, Nakamura Y, et al. Epidemiologic pic-tures of Kawasaki disease in Japan: From the nationwide surveyin 1991 and 1992. Pediatrics. 1995;95:475–479.

25. Yanagawa H, Yashiro M, Nakamura Y, et al. Results of 12 nation-wide epidemiological incidence surveys of Kawasaki disease inJapan. Arch Pediatr Adolesc Med. 1995;149:779–783.

26. Yanagawa H, Nakamura Y, Yashiro M, et al. Update of theepidemiology of Kawasaki disease in Japan: from the results of1993–1994 nationwide survey. J Epidemiol. 1996;6:148–157.

27. Yanagawa H, Nakamura Y, Yashiro M, et al. Results of thenationwide epidemiologic survey of Kawasaki disease in 1995and 1996 in Japan. Pediatrics 102.URL:http://www.pediatrics.org/cgi/content/full/102/6/e65.

28. Yanagawa H, Nakamura Y, Yashiro M, et al. Incidence survey ofKawasaki disease in 1997 and 1998 in Japan. Pediatrics. 2001;107.URL:http://www.pediatrics.org/cgi/content/full/107/3/e33.

29. Yanagawa H, Yashiro M, Nakamura Y, et al. Results of 12 nation-wide epidemiological incidence surveys of Kawasaki disease inJapan. Acta Pediatr Adolosc Med. 1995;149:779–783.

30. Kubota S. Epidemiological studies on so-called Kawasaki dis-ease (acute febrile muco-cutaneous lymph node syndrome).Nippon Ika Daigaku Zasshi. 1978;45:321–337. (in Japanese)

31. Lee DB. Kawasaki disease in Korea. Excerpta Medica Fuji Con-ference on Kawasaki Syndrome, Fuji, Oct 1983.

32. Cremer HJ. Das Kawasaki-Syndrome in der Bundesrepublik.Paediat Prax. 1981;25:243–260.

33. Melish M. Hawaian epidemiology. Second InternationalKawasaki Disease Symposium, Hawaii, 1986.

34. Fujita Y, Nakamura Y, Sakata K, et al. Kawasaki disease infamilies. Pediatrics. 1989;84:666–669.

35. Uehara R, Yashiro M, Nakamura Y, Yanagawa H. Kawasakidisease in parents and children. Acta Paediatr. 2003;92:694–697.

36. Nakamura Y, Hirose K, Yanagawa H, et al. Incidence rate ofrecurrent Kawasaki disease in Japan. Acta Paediatr. 1994;83:1061–1064.

37. Yanagawa H, Yashiro M, Nakamura Y, et al. Cardiac sequelaeand relating factors among Kawasaki disease patients reportedin recent 6 years. Shonika Rinsho. 1997;50:2129–2133. (inJapanese)

38. Nakamura Y, Yanagawa H, Ojima T, et al. Cardiac sequelae ofKawasaki disease among recurrent cases. Arch Dis Child. 1998;78:163–165.

39. Yanagawa H, Tuohong Z, Oki I, et al. Effects of gamma-globulinon the cardiac sequelae of Kawasaki disease. Pediatr Cardiol.1999;20:248–251.

40. Hirata S, Nakamura Y, Yanagawa H. Incidence rate of recurrentKawasaki disease and related risk factors: from the results ofnationwide surveys of Kawasaki disease in Japan. Acta Paediatr.2001;90:40–44.

41. Nakamura Y, Koyanagi H, Yanagawa H, et al. Risk factors ofgiant coronary aneurysms due to Kawasaki disease: a com-parison between cases and Kawasaki disease patients without


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cardiac sequelae. Nippon Shonika Gakkai Zasshi. 1997;101:782–788. (in Japanese)

42. Nakamura Y, Oki I, Tanihara S, et al. Cardiac sequelae in recur-rent cases of Kawasaki disease: a comparison between the ini-tial episode of the disease and a recurrence in the same patients.Pediatrics. 1998;102:e66.

43. Yashiro M, Oki I, Nakamura Y, et al. Epidemiologic pictures offatal cases of patients with Kawasaki disease reported in 15nationwide surveys. Nippon Shonika Gakkai Zasshi. 2000;104:1179–1183. (in Japanese)

44. Nakamura Y, Yanagawa H, Kawasaki T. Mortality among chil-dren with Kawasaki disease in Japan. N Eng J Med. 1992;326:1246–1249.

45. Nakamura Y, Yanagawa H, Kato H, Kawasaki T. Mortality ratesfor patients with a history of Kawasaki disease in Japan. J Pediatr.1996;128:75–81.

46. Nakamuara Y, Yanagawa H, Kato H, et al. Mortality amongpatients with a history of Kawasaki disease: The third look. ActaPaediatr Jpn. 1998;40:409–423.

47. Yanagawa H, Nakamura Y, Sakata K, et al. Use of intravenous�-globulin for Kawasaki disease: effects on cardiac sequelae.Pediatr Cardiol. 1997;18:19–23.

48. Zhang T, Yanagawa H, Oki I, et al. Factors related to cardiacsequelae of Kawasaki disease. Eur J Pediatr. 1999;158:694–697.

49. Nakamura Y, Ogane H, Yanagawa H. Observation of the inci-dence of Kawasaki disease in small geographic units in 1979and 1982 epidemics in Japan. Acta Paediatr Jpn. 1984;31:539–547.

50. Nakamura Y. Geographical and temporal clustering of Kawasakidisease in Japan. Nippon Shonika Gakkai Zasshi. 1987;91:896–910. (in Japanese)

51. Takeuchi S, Yanagawa H, Kawasaki T, et al. An epidemic ofKawasaki disease in Miyako Island, Okinawa Prefecture. NipponShonika Gakkai Zasshi. 1982;86:1965–1972. (in Japanese)

52. Nakae K, Usami T, Morisawa Y, et al. An epidemiological studyon so-called Kawasaki disease (acute febrile muco-cutaneouslymphnode syndrome): a community study in M town, TochigiPrefecture. Shonika. 1983;24:339–343. (in Japanese)

53. Ohshima K, Tominaga M, Yanagawa H, et al. Area aggregationof MCLS in Yachiyo-shi, Chiba Prefecture. Shonika. 1977;18:65–71. (in Japanese)

54. Takahashi K, Takiguchi M, Mori T, et al. Epidemiological study ofMCLS: observation of time-space relationship. Shonika Rinsho.1983;36:1273–1277. (in Japanese)

55. Nanri T, Fukuda H. Kawasaki disease: clinical observations of12 recurrent cases and 4 pairs of siblings, containing 2 cases ofmultiple recurrence and near onset each of two times in twins.Shonika. 1983;24:357–362. (in Japanese)

56. Yanagawa H. Results of epidemiology. Report of JapaneseCommittee of Investigation of the Causes of Kawasaki Disease.Tokyo: Japanese Heart Association; 1985:13–23. (in Japanese)

57. Yanagawa H, Ogane H, Hashimoto T. Epidemiology of Kawasakidisease. Shoni Igaku. 1984;17:910–925. (in Japanese)

58. Yanagawa H. Results of epidemiology. Report of JapaneseCommittee of Investigation of the Causes of Kawasaki Disease.Tokyo: Japanese Heart Association; 1985:13–17. (in Japanese)

59. Kubota S. Epidemiological studies on so-called Kawasaki dis-ease (acute febrile muco-cutaneous lymph node syndrome).Nippon Ika Daigaku Zasshi. 1978;45:321–337. (in Japanese)

60. Kishimoto T, Kotake H, Kato S, et al. A case-control study ofKawasaki disease. [abstract]. Nippon Eiseigaku Zasshi. 1980;35:346. (in Japanese)


194

Review Article

Current Treatment Strategies forCoronary Disease in Japan

JMAJ 48(4): 194–200, 2005

Ryo Koyanagi,*1 Naomi Kawashiro,*1 Hiroshi Ogawa,*1 Yukio Tsurumi,*1

Hiroshi Kasanuki,*1 Katsumi Nakata*2

AbstractDespite the remarkable progress in diagnosis and treatment, acute coronary syndrome (ACS) remainsan important public health problem demanding much effort from cardiologists.

A comparison of the Japanese and the U.S. guidelines for ACS shows that they differ in theprovisions concerning institutional requirements and the skill of persons performing the procedure. Ifwe apply the U.S. guidelines to the situation in Japan, 46.9% of PCI cases are receiving PCI at centersfailing to meet the U.S. standards.

While the inclination toward the use of PCI in Japan is considered to expand further, care providersare expected to make self-imposed effort aiming at the establishment of more stringent institutionalrequirements and further skills accumulation. They should improve the ability to deduce well-balancedconclusions through the process of analyzing actual needs based on the combination of social, basic,and clinical medicine.

Key words Acute coronary syndrome, Acute myocardial infarction, Institutional requirements,Pre-hospital care system, Guidelines, Drug-eluting stent

In the recent analysis of MI patients fromthe Japanese Coronary Intervention Study,Nishigaki et al.3 of Gifu University reportedthat the occurrence of MI in Japan (about 52per 100,000 population) was 4 times lowerthan that in the U.S. (192 per 100,000 popu-lation). The majority of this difference maybe due to diet and other acquired factors, inaddition to hereditary factors.

Among the various types of heart disease,acute coronary syndrome (ACS) includingMI remains the main challenge for cardiolo-gists, although the diagnosis and treatmentof ACS have progressed remarkably in recentyears by the use of diagnostic imaging, reper-

Introduction

According to the Vital Statistics Reportpublished by the Ministry of Health, Labourand Welfare (MHLW), heart disease wasresponsible for 152,000 deaths in 2002 inJapan. It was the second most importantcause of death representing 15.5% of alldeaths.1 The 5th National Survey of Circula-tory Disorders indicated that a history ofmyocardial infarction (MI) was found in2.4% of males and 1.1% of females, while ahistory of angina pectoris was found in 3.6%of males and 2.9% of females.2

*1 Department of Cardiology, Heart Institute of Japan, Tokyo Women’s Medical University, Tokyo, Japan*2 Chief for Emergency Medical Service, Guidance of Medical Service Division, Health Policy Bureau, Ministry of Health,Labour and Welfare, JapanCorrespondence to: Ryo Koyanagi MD, Department of Cardiology, Heart Institute of Japan, Tokyo Women’s Medical University,8-1, Kawadacho, Shinjuku-ku, Tokyo 162-8666, Japan. Tel: 81-3-3353-8111, Fax: 81-3-3356-0441, E-mail: [email protected]


195

fusion therapy, and other techniques. Thedifficulty arises from the facts that ACSshows rapid progression in a very concen-trated time span; it requires approaches notonly in the area of cardiology but also fromemergency medicine, social medicine, andmedical economics; and that careful initialassessment and accurate treatment defi-nitely contribute to the survival prognosis ofpatients.

For these reasons, this review focuses onACS among other types of coronary disease.

Definition

ACS is defined as a clinical syndrome char-acterized by acute myocardial ischemiaresulting from coronary plaque ruptureand thrombosis. It encompasses a wide rangeof conditions from acute MI and unstableangina to sudden cardiac death.

Coronary Disease Practice in Japan

The geography and health care systems ofJapan are important factors in consideringACS in Japan. Japan has a very high popula-tion density: 90% of the 127 million peopleinhabit coastal areas occupying a small pro-portion of the 378,000-km2 national landarea.4

With this densely distributed popula-tion, effective emergency care systems havebeen established under the lead of thegovernment.

In particular, the MHLW and the Fire andDisaster Management Agency, Ministry ofInternal Affairs and Communications havebeen developing a system for providing pre-hospital care. The scope of medical treat-ment that emergency medical technicians(EMTs) are allowed to perform has beenexpanded gradually. For example, they havebeen allowed to perform electrical cardio-version under the general direction of aphysician (without specific instruction) sinceApril 2003. Endotracheal intubation hasbeen permitted for EMTs completing

schooling and hospital training under thespecific instruction of a physician since July2004. As for drug use, a study on the minimaluse of epinephrine and other drugs wasconducted to evaluate the efficacy and safetyin the use by EMTs, and the government hasdecided to permit the use of epinephrine byEMTs from April 2006.

The MHLW has been leading the devel-opment of primary, secondary, and tertiaryemergency care systems organized accord-ing to new function-based role sharing. As ofMarch 2005, 176 emergency care centershave been established to provide medicalservices as tertiary emergency care facilities.5

Under this system, all Japanese citizensare given unrestricted access to any medicalinstitution under the national health insur-ance system. A person developing ACS inJapan can visit any appropriate medicalinstitution. At some medical centers, the unitprices of health care cost (drugs and medicalsupplies) are standardized uniformly accord-ing to the Diagnosis Process Combination(DPC) system. This factor is exerting a deci-sive effect on the behavior of patients.

Treatment Strategies for CoronaryDisease

Several sets of guidelines are provided for themanagement of ACS in Japan. The guidelinesfor the management of acute MI have beendeveloped by the MHLW study group led byKanmatsuse. Those for non-ST-segmentelevation ACS have been formulated by thejoint study group of the Japanese CirculationSociety, the Japanese College of Cardiology,the Japan Society for Intervention, the Japa-nese Coronary Association, the JapaneseAssociation for Thoracic Surgery, the Japa-nese Society for Cardiovascular Surgery,and the Japanese Society of Intensive CareMedicine.

In the U.S., the American Heart Associa-tion (AHA) has established ACC/AHAGuidelines for the Management of Patientswith Acute Myocardial Infarction, as well as

CURRENT TREATMENT STRATEGIES FOR CORONARY DISEASE IN JAPAN


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ACC/AHA Guidelines for the Manage-ment of Patients with Unstable Anginaand Non-ST-Segment Elevation MyocardialInfarction for other types of ACS.6–10

Comparison with Other Countries

The treatment strategies for ACS are dividedinto early invasive treatment and early con-servative treatment according to the timingof coronary angiography (CAG) and revas-cularization. In the early invasive strategy,elective CAG is performed early in all hospi-talized cases unless there is a contraindica-tion, and revascularization is performed ifindicated. In the early conservative strategy,CAG is selected only in cases that are con-sidered clinically high risk and those experi-encing repeated myocardial ischemic attacksdespite adequate drug therapy. Thus, thetiming of CAG is a major difference betweenthese strategies. No conclusion has beenreached as to which of these strategies isbetter.

As shown in Table 1, there is little differ-ence in primary PTCA in acute MI betweenthe Japanese and American guidelines.

In both countries, the recommendationsfor Class I conditions specify the following:“In patients with acute MI and ST-segmentelevation or new or presumed new left bundlebranch block (LBBB) who can undergoangioplasty of the infarct-related arterywithin 12 hours of onset of symptoms orbeyond 12 hours if ischemic symptomspersist, if performed . . . by persons skilledin the procedure and . . . in an appropriatelaboratory environment.” They also state,“In patients who are within 36 hours of anacute ST-elevation/Q-wave or new LBBBMI who develop cardiogenic shock, are �75years old, and in whom revascularization canbe performed within 18 hours of onset ofshock.”

The difference lies in the definitionsregarding the institutional requirements andthe skill of the persons performing the pro-cedure. According to the health insurance

Table 1 Comparison of Japanese and U.S. guidelines concerning primary PTCA and institutional requirements

PrimaryPTCA

ACC/AHA guidelines for the management ofpatients with acute myocardial infarction

As an alternative to thrombolytic therapy in patientswith AMI and ST-segment elevation or new orpresumed new left bundle branch block who canundergo angioplasty of the infarct-related arterywithin 12 hours of onset of symptoms or beyond12 hours if ischemic symptoms persist, if performedin a timely fashion by persons skilled in theprocedure*2 and supported by experiencedpersonnel in an appropriate laboratoryenvironment*1.

*1: At least 200 cases of PTCA per year.

*2: At least 75 cases of PTCA per year.

Guidelines for the diagnosis and treatment ofacute myocardial infarction

In patients with AMI and ST-segment elevation ornew or presumed new left bundle branch block whocan undergo angioplasty of the infarct-related arterywithin 12 hours of onset of symptoms or beyond12 hours if ischemic symptoms persist, if performedby persons skilled in PTCA in an appropriateinstitutional environment (meeting theinstitutional requirements specified by MHLW).

Institutional requirements specified by MHLW:1. A medical institution practicing in cardiovascular

medicine.2. At least 1 full-time physician with 10 or more

years of experience in the procedure.3. At least 1 full-time cardiovascular surgeon with

5 or more years of experience or a partnershipwith a medical institution employing a physicianwith such experience.

4. At least 1 full-time clinical engineer.5. At least 100 cases in the institution per year.

Koyanagi R, Ogawa H, Tsurumi Y, et al.


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reimbursement standards of Japan, a centerperforming PTCA must have at least 1 full-time physician with 10 or more years experi-ence and there must be at least 100 casesoperated on at the center per year. There areno requirements concerning the skill of phy-sicians and the number of cases operated onby each physician. On the other hand, theguidelines in the U.S. provides for specificnumerical requirements that each physicianmust have experienced 75 or more cases ofPTCA and each center must be performing200 or more cases of PTCA per year.

Another difference between the Japaneseguidelines and the AHA guidelines relatesto arrhythmia. The Japanese guidelines donot indicate amiodarone for ventricular

tachycardia and ventricular fibrillation(Table 2) because intravenous amiodarone isnot provided for under the national healthinsurance. Nifekalant, a K ion channel blockerof Japanese origin, is already covered by thenational health insurance, and this drug mayappear in the Japanese guidelines ahead ofWestern countries after further accumula-tion of evidence.

In addition, the Japanese guidelines donot contain clopidogrel as an antiplateletdrug (Table 2). Like amiodarone, this drug isnot provided for under the national healthinsurance. Since clopidogrel acts morequickly than ticlopidine and has a bettersafety profile, it is the first-choice drugamong thienopyridine derivatives in the U.S.

Table 2 Comparison of medical therapies in Japanese and U.S. guidelines

Treatment forventricular

tachycardia/ventricularfibrillation

Antiplateletand

anticoagulationtherapy

ACC/AHA guidelines for the management ofpatients with acute myocardial infarction

Class ISustained monomorphic VT not associated withangina, pulmonary edema, or hypotension (bloodpressure less than 90mmHg) should be treatedwith one of the following regimens:a. Lidocaine.b. Procainamide.c. Amiodarone.d. Synchronized electrical cardioversion starting at

50 J (brief anesthesia is necessary).

ACC/AHA guidelines for the management ofpatients with unstable angina and non-ST-segmentelevation myocardial infarction

● Clopidogrel should be administered to hospitalizedpatients who are unable to take ASA becauseof hypersensitivity or major gastrointestinalintolerance. (Level of evidence: A)

● In hospitalized patients in whom an earlynoninterventional approach is planned,clopidogrel should be added to ASA as soon aspossible on admission and administered for atleast 1 month (Level of evidence: A), and for upto 9 months. (Level of evidence: B)

● In patients for whom a PCI is planned and whoare not at high risk for bleeding, clopidogrelshould be started and continued for at least1 month (Level of evidence: A), and for up to9 months. (Level of evidence: B)

Guidelines for the diagnosis and treatmentof acute myocardial infarction

Class I4. Intravenous lidocaine or procainamide for

sustained monomorphic VT not associated withangina, pulmonary congestion, or hypotension(systolic blood pressure less than 90mmHg).

5. Synchronized electrical cardioversion forsustained monomorphic VT not associated withangina, pulmonary congestion, or hypotension(systolic blood pressure less than 90mmHg)(brief anesthesia is necessary).

Guidelines for the management of acutecoronary syndrome

● Chewable aspirin 162 to 325mg should beadministered as soon as possible, followed bylong-term administration of 50 to 100mg.

● Ticlopidine should be administered to patientswho are unable to take aspirin.



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Because ticlopidine causes granulocytope-nia as a serious adverse effect, clopidogrelshould be covered by the Japanese nationalhealth insurance as soon as possible.

PTCA or CABG

In the above-mentioned guidelines, recom-mendations concerning emergency or urgentbypass graft for Class I conditions differ littlebetween Japan and the U.S. These are:“Failed angioplasty with persistent pain orhemodynamic instability,” “AMI with per-sistent or recurrent ischemia refractoryto medical therapy in patients . . . who arenot candidates for catheter intervention,”and “Postinfarction ventricular aneurysmassociated with intractable ventriculartachyarrhythmias and/or pump failure.” Anotable difference is found in the recom-mendations for Class III (conditions forwhich there is evidence and/or generalagreement that a procedure/treatment isnot useful/effective and in some cases maybe harmful). While the AHA guidelines onlystate, “When the expected surgical mortalityrate equals or exceeds the mortality rateassociated with appropriate medical therapy,”the Japanese guidelines contain the follow-ing: “When PTCA has failed but reperfusionis impossible because of a no-flow condi-tion,” “In the case of reperfusion beyond 12hours of an ST-segment elevation (Q-wave)infarction without ongoing ischemia,” and“When the expected surgical mortality rateequals or exceeds the mortality rate associ-

ated with appropriate medical therapy.”It is often pointed out that percutaneous

coronary intervention (PCI) is performedmuch more frequently than coronary arterybypass graft (CABG) in Japan, while thedifference is smaller in Western countries.According to the above-mentioned nation-wide survey on coronary intervention per-formed in 2000, reported by Nishigaki et al.11

in 2003, there were 543,046 cases of CAG(428 per 100,000 population), 146,992 casesof PCI (116 per 100,000 population), and23,584 cases of CABG (19 per 100,000 popu-lation) performed in Japan. The correspond-ing figures in the U.S. were 1,318,000 cases ofCAG (468 per 100,000 population), 561,000cases of PCI (199 per 100,000 population),and 519,000 cases of CABG (184 per 100,000population) (Table 3). Because the preva-lence of coronary artery disease (CAD) per100,000 population was 4,584 in the U.S.versus 3,199 in Japan (data for 2000), thefraction of CAD cases receiving CAG was1.4 times higher in Japan than in the U.S.

In Japan, 59.8% of the medical centersperforming PCI were each performing lessthan 100 cases of PCI per year, and 20.9% ofall PCI cases in Japan received PCI at suchcenters. Furthermore, 46.9% of PCI casesreceived this procedure at centers perform-ing less than 200 cases of PCI per year.

Only 20.7% received PCI at the centersperforming 400 or more cases of PCI peryear.

With respect to the number of centersperforming these procedures, the data from

Table 3 Number of coronary intervention cases in Japan and the U.S. in 2000

Japan United States

CasesPer 100,000

CasesPer 100,000

population population

CAG 543,046 428 1,318,000 468

PCI 146,992 116 561,000 199

CABG 23,584 19 519,000 184



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this survey and those from a similar ques-tionnaire survey conducted by Takeshitaet al.12 in 1997 indicate that the number ofcenters performing PCI increased from1,023 to 1,240, and those performing CABGincreased from 486 to 581.

While CABG was performed in over20,000 patients in the year, 91.7% of thecenters performing CABG were each per-forming less than 100 cases of CABG peryear, and as many as 71.2% of all CABGcases in Japan received CABG at such cen-ters. The centers performing less than 50cases of CABG per year represented 70.9%of the centers performing CABG and 37.2%of the patients receiving this procedure.

The ratio of PCI to CABG was as high as6.23 in overall average. It was “0 to 3” in 30%of centers, “3 to 5” in 20%, “5 to 8” in 23%,and “8 or more” in 27%. Larger numbersindicate a stronger bias toward the use ofPCI relative to CABG. About 60% of cen-ters were performing more CABG than PCI.

These data indicate that about half ofpatients with acute coronary disease inJapan are receiving PCI at centers that areperforming less than 200 cases per year,which do not meet the standards of AHAguidelines. They also suggest that the treat-ment of coronary disease is biased towardthe use of PCI.

Although PCI is used actively for leftmain trunk (LMT) disease in Japan, a surveyby Nishida13 showed that the mortalityrate associated with elective PCI for LMTdisease is significantly higher than that asso-ciated with CABG. Unfortunately, therehas been no move to correct this perturbingsituation.

Nishida et al.14 remarked, “While sur-geons work with CABG and cardiologistswork with PCI toward improvement of tech-niques and outcomes, they lack sufficientinformation exchange concerning the selec-tion of treatment methods both at the levelof individual hospitals and at the level ofacademic societies.” We need to promotecloser communication among cardiologists

and surgeons in order to realize betterdemarcation based on objective data.

Toward Further Skill Accumulation

While PCI and CABG are performed atmany centers in Japan, 46.9% of PCI casesare performed at centers treating less than200 cases, failing to meet the AHA stan-dards, and 91.7% of CABG cases are per-formed at centers treating less than 100cases. This fact suggests the direction thatshould be pursued in future cardiovascularpractice.

In the present system, a patient develop-ing coronary disease anywhere in Japan issent to the nearest secondary care center ona free (uncontrolled) access basis. After theemergency room physician makes diagnosisof coronary disease, PCI, CABG, or othertreatment is given, if the center is capableof performing the needed procedure. Ifnot, arrangements are made for transportingthe patient to a center with the necessaryfacilities.

The free access system may seem ideal,but it could end in loss of life, if the patient issent to a center with little experience andinsufficient technical skill. In fact, about halfof the medical centers in Japan are deficientin skill according to the AHA guidelines.

Ideal emergency cardiovascular careshould begin with effective pre-hospital care.In our opinion, emergency personnel in theambulance should be able to conduct initialtriage, judge the presence of coronary dis-ease, and transport the patient to a centertreating a sufficient number of PCI orCABG cases with highly experienced,skilled physicians.

To this end, we need to build on the cur-rent efforts to develop the medical controlsystem, to improve the abilities of EMTssuch as advanced cardiovascular life support(ACLS), and to reinforce pre-hospital caresystems in communities. On the side of healthcare providers, we need to continue furtherdevelopment of the guidelines both for PCI



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and CABG, incorporating more stringentinstitutional requirements and establishingthe potential for skill accumulation.

Final Remarks and RemainingProblems

As discussed above, the treatment selectionfor ACS in Japan is too biased toward theuse of PCI. A new type of stent called drug-eluting stent (DES)12 came into clinical userecently, and was popularized quickly to beemployed in over 70% of cases nationwidewithin months of introduction. We do notdiscuss the merits and demerits of this treat-ment here, but this device has the potentialto intensify the excessive use of PCI. In addi-tion, the antiplatelet agent used in Japan isticlopidine hydrochloride, because clopidogrelhas not been approved. Almost nothing isknown about the short- and long-term out-come of ticlopidine hydrochloride adminis-tration in patients receiving DES, and theresults of data analysis from DES patientregistration in Japan (e.g., J-cypher) are

awaited. This drug causes granulocytopeniaas a serious adverse effect, which poses animportant problem for clinicians in terms ofpatient’s safety.

On the other hand, the widespread use ofDES and the further development of diag-nostic imaging are expected to decrease theneed for invasive CAG for follow-up pur-poses. This should be good news for patients.

Finally, patients with ACS in Japan aremore frequently complicated with diabetesthan those in Western countries, as a result ofthe genetic predisposition of the Japanesepeople. This fact is extremely important fromthe standpoint of prophylaxis.

Cardiologists and cardiac surgeons inJapan should not simply depend on theadvancement of treatment methods anduncritically adopt the newest therapies.Rather, they should develop the ability todeduce well-balanced conclusions throughthe process of analyzing the actual needsbased on the combination of social medicine,basic medicine, and clinical medicine.

References

1. Ministry of Health, Labour and Welfare. 2002 Vital StatisticsReport, Yearly Summation of Monthly Reports (ApproximateData).

2. Ministry of Health, Labour and Welfare. The 5th National Surveyof Circulatory Disorders.

3. Assessment of Acute Myocardial Infarction in Japan by the Japa-nese Coronary Intervention Study (JCIS) Group. CirculationJournal. 2004;68(6):515–519.

4. Ministry of Internal Affairs and Communications. “National Cen-sus” 2000.

5. Ministry of Health, Labour and Welfare. “Trends in NationalHygiene” 2004.

6. Ministry of Health, Labour and Welfare. Guidelines for theDiagnosis and Treatment of Acute Myocardial Infarction(Kanmatsuse [Nihon University] and colleagues, MHLW Grant-in-Aid Research Group).

7. ACC/AHA Guidelines for the Management of Patients withAcute Myocardial Infarction. J Am Coll Cardiol. 1996;28(5):1328–1428.

8. 1999 update: ACC/AHA Guidelines for the Management ofPatients with Acute Myocardial Infarction. Executive Summaryand Recommendations Circulation. 1999;100(9):1016–1030.

9. Guidelines for the Management of Acute Coronary Syndrome(JCS, 2002).

10. ACC/AHA Guidelines for the Management of Patients withUnstable Angina and Non-ST-Segment Elevation MyocardialInfarction. Circulation. 2002;106(14):1893–1900.

11. Assessment of Coronary Intervention in Japan from the Japa-nese Coronary Intervention Study (JCIS) Group. CirculationJournal. 2004;68(3):181–185.

12. “Survey on Coronary Intervention in Japan and Development ofGuidelines,” Study Report of Health Science General ResearchProject by FY 1998–2000 MHLW Grant-in-Aid. (in Japanese)

13. Nishida H. Kandomyaku baipasu jutsu. In: Yamaguchi T, Hori S,ed. Junkanki Shikkan Saishin no Chiryo 2004–2005. Tokyo:Nankodo; 2004:120–125. (in Japanese)

14. Nishida H. Surgery for ischemic heart disease in Japan: Historyand results of two annual national surveys conducted by Japa-nese Association for Thoracic Surgery and Japanese Associa-tion for Coronary Artery Surgery. The Journal of the JapaneseCoronary Association. 2003;9(3):173–178. (in Japanese)

15. Sirolimus for the prevention of in-stent restenosis in a coronaryartery. N Engl J Med. 349:14.



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*1 President, Japan Medical Association, Tokyo, JapanCorrespondence to: Haruo Uematsu MD, PhD, Japan Medical Association, 2-28-16, Honkomagome, Bunkyo-ku, Tokyo 113-8621, Japan.Tel: 81-3-3946-2121, Fax: 81-3-3946-6295, E-mail: [email protected] address was provided at the 112th General Assembly of the JMA House of Delegates held in Tokyo on March 27, 2005.

Policy Address

JMAJ 48(4): 201–203, 2005

Haruo Uematsu*1

We saw the occurrence of many naturaldisasters in Japan last year, beginning withthe typhoons and flooding in Fukui Prefec-ture and other regions, the Chuetsu earth-quake in Niigata Prefecture, and the offshoreearthquake in Fukuoka Prefecture. I wouldlike to express my condolences to each pre-fectural medical association in these affectedregions, and hope for a quick recovery.

In addition, thanks to your cooperation,the JMA was able to raise 117 million yen(about US$ 1.1million) in donations for therelief activities in the regions hit by the off-shore Sumatra earthquake and tsunami inthe Indian Ocean. The total amount was dulydonated to the Japanese Red Cross Societythrough the services of the Japan Broad-casting Corporation (NHK) on March 25.Thank you very much for your support.

Contributing to Health Policy withthe Japanese Public

Like the vast majority of JMA members, Iam also seriously concerned about the regu-latory reforms that are being pursued basedon market economy principles advocated bythe Council on Fiscal and Economic Policy,the Ministry of Finance, and others, and Irecognize how important it is for us to takeaction that communicates our concerns. Ourbasic stance, which we have consistentlyadvocated, is to adhere to social security

principles and to firmly maintain the univer-sal health insurance.

We have been galvanized into resolutelyopposing the removal of the ban against anattempt to mix public and private insurance(mixed public/private insurance) as statedin Prime Minister Koizumi’s policy speechon October 12, 2004 because we believe thatthis will lead to the destruction of the uni-versal national health insurance system andstratification between the rich and poor interms of equal access to health care services.

But, an opposition movement comprisedof health related associations headed by theJMA will only serve to dismiss our effortsas being self-serving. Therefore, we carriedout our activities to safeguard the universalhealth insurance in conjunction with thesupport and cooperation of the Japanesepeople.

In line with this strategy, the JMA estab-lished the Committee on National HealthPromotion, which is composed of 37 organi-zations and aims at organizing a publicmovement to safeguard the universal healthinsurance and to oppose the removal ofthe ban on mixed public/private insurance.An opposition petition drive was started tocollect the signatures of each local medicalassociation. Over 6,600,000 signatures werecollected, and on November 30, we petitionedthe presidents of both the Upper and LowerHouses and won the approval of about 80

202

Uematsu H


percent of the ruling party members. Subse-quently, it was adopted on December 3, 2004.This is the first time in constitutional politicswhere a petition opposing the administrativepolicy of a prime minister was successfullyadopted.

I would like to express my deep gratitudeto you in conjunction with the great joy thatI feel at successfully achieving our initialgoals with the support and participation ofthe Japanese people. During this criticaltime, the JMA was able to set up health pro-motion councils in different regions nation-wide. We will continue to expand our tieswith medical associations, other health orga-nizations, and with the public through oursuggestions and proposals on a variety ofhealth care issues and thereby contribute toJapan’s health policies.

Through these activities, Mr. HidehisaOtsuji, the Minister of Health, Labour andWelfare and Mr. Seiichiro Murakami, theMinister of State for Regulatory Reform havereexamined the Special Healthcare Expend-iture scheme and an understanding wasreached on such issues as the introductionof insurance coverage for new medical tech-nology, patient choice or the number oftreatments under insurance coverage, andunapproved drugs in Japan. However, thespecific content of each of these issues mustbe further reviewed and deliberated. There-fore, we will actively continue our lobbyingactivities.

With regard to the reexamination of theCentral Social Insurance Medical Council(Chuikyo), our efforts have achieved somesuccess and progress when it was decidedthat the body responsible for reviewing themembers of Chuikyo, would be established inthe Ministry of Health, Labour and Welfareas we had advocated, despite the fact thatthe initial plan was to assign it within theCabinet Office.

Expanding Financial Resources toMeet Healthcare Costs

After obtaining information that the intro-duction of a medical license renewal systemhad been included in the initial report onregulatory reforms, we took immediate polit-ical action to oppose it and we were able tosuccessfully eliminate it the following day. Adetailed examination of their deliberationsshowed that they were tenacious in advo-cating their viewpoints even after they hadbeen officially defeated. Therefore, we mustremain vigilant and must not miss timelyopportunities to voice our opposition and toadvocate our views.

This coming year is extremely importantto JMA in terms of the draft revision forthe Long-Term Care Insurance Law that hasbeen submitted to the Diet as well as therevision of medical fee schedule to be en-forced in April, 2006. Although issues such ascontrolling health costs and reviewing therange of public insurance coverage are underdebate by government and business leaderswho feel that health costs should not beincreased, what is presently demanded bythe public is patient safety, improved qualityin health care, and expanding the SpecialHealthcare Expenditure. Thus, curbing healthcosts is a difficult task.

In order for its view to be publicly acknowl-edged, the JMA must promote its effortsamong the Japanese people. It is importantfor the public to be aware of our activities topromote CME, to achieve self-improvement,to address ideas about medical license renew-als, and to carry out preventive measuresthat protect national health, in order tocontrol increasing health costs in future.

Although the JMA has been continuouslyactive in the antismoking movement, we havenow created a new conference to promotecountermeasures against diabetes in coop-eration with the Japan Diabetes Society etc.Through these activities, we will promoteour view that health care should not be

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POLICY ADDRESS


tailored to meet economic needs, but rather,the economy should be tailored to meethealth care needs. Based on this view, we willcontinue to demand that financial resourcesbe increased to meet health costs.

Establish a Health Care System thatthe Public Truly Needs

Presently, the fifth revision of Medical Ser-vice Law is underway, and we will continueour efforts to create a safe and qualityhealthcare system demanded by the Japa-nese people.

As of April 1, 2005, the Act for Protectionof Computer Processed Personal Data heldby Administrative Organs was enforced, andthe JMA is giving guidance to local medicalassociations and its members on how tocomply with it. I would like to ask thatcooperation be given without any errors, butsince we, physicians, have always placedimportance on protecting individual data, I,personally, believe that we need not be

excessively concerned.Many have vociferously pointed out the

shortage of physicians that has accompaniedcompulsory clinical training for new physi-cians, but it is unclear as to whether there isan absolute shortage or whether regionalfactors or uneven distribution according topreference in selecting specialties by youngphysicians is the cause of this shortage. Toaccurately assess the situation, JMA hasbegun a survey study.

In addition, informal discussion meetingsfor JMA’s women members were startedand active discussions have taken place. Agender equality forum will be held in Julyaimed at exploring new perspectives anddifferent viewpoints. It is anticipated thatthis forum will also contribute ideas on theissue of physician shortages.

In conclusion, I hope that I have ade-quately discussed JMA’s current activitiesand policies. Thank you very much for yourkind attention.

204

*1 Executive Board Member, Japan Medical Association, Tokyo, JapanCorrespondence to: Nobuya Hashimoto MD, PhD, Japan Medical Association, 2-28-16, Honkomagome, Bunkyo-ku, Tokyo 113-8621, Japan.Tel: 81-3-3946-2121, Fax: 81-3-3946-6295, E-mail: [email protected]


Introduction

In 1984, the Japan Medical Association(JMA) focused attention on the importanceof continuing medical education (CME) forphysicians by organizing a committee for thepromotion of this topic.

Based on the recommendations of theCME promotion committee, the JMA orga-nized a second committee to study CMEprograms in 1985. After considerable dis-cussion and a 6-month trial period, a CMEprogram officially started for all JMA mem-bers in April, 1987.

Since then, 17 years have passed. Thanksto input from many fields as well as theactive participation and cooperation of JMAmembers, the CME program has successfullydeveloped.

This paper reports the current situation ofthe CME program of the JMA, and touchesupon the future issues.

Transition of CME Filing Ratio

Since the start of the CME program, theJMA has required its members to voluntar-ily file the number of units representing theirannual performance related to CME such asattendance at lectures and participation inacademic conferences. To streamline the

filing system, however, a new “collectivefiling” system was introduced in 1996 whereeach local medical association collectivelymanages a computerized database of itsmembers.

The filing ratio was good, 64.2% on anaverage, just after the CME program startedin 1988. Regretfully, however, it continueddecreasing, and finally dropped below 40%,39.8% exactly, in 1994, seven years after theintroduction of the program. The filing ratiofor physicians at clinics was 51.3, while thatfor hospital physicians was 24.0 (See Fig. 1).It was assumed that hospital physicians actu-ally received continuing medical educationthrough daily clinical activities includingclinical and academic conferences, and vari-ous academic activities, but did not reportthese activities as required by the JMA.

Assuming the filing ratio is the only datathat represents CME performance statusfor physicians, however, a filing ratio of40% cannot be ignored. This low figure cre-ated a sense of crisis among CME committeemembers.

At that same time, there was a movementtoward accreditation of specialists withineach medical society. Associated with thismovement, announcement of a medicalspecialty and public advertisement issuesbecame a focus of attention. As a result, anincreasing number of general practitioners

Current and Future Issues inContinuing Medical Educationby the Japan Medical Association

JMAJ 48(4): 204–208, 2005

Nobuya Hashimoto*1


205

re-joined the medical society they once quitto obtain a “qualification certificate” issuedby the medical society.

As a result, the JMA was often asked byits members, “What are the merits to us ofthe system of CME designed by the JMA?”

Through detailed analysis of the situationand repeated discussion about its “carrot-and-stick strategy in continuing education,”the CME committee of the JMA concludedthat the CME program should be based onwhat is called intrinsic motivation in the edu-cational field. That is, physicians as profes-sionals should receive continuing educationvoluntarily for the sake of their patients, butit should not be obligatory, just like whenchildren are told to study by their parents.

After that, thanks to the efforts of manypeople involved, the filing ratio increased. Itwas back to 60% in 1999, almost the samelevel as that at the start of the CME system,and it reached as high as 70% (69.6%) onan average in 2002. This increase means animprovement in awareness of CME amongJMA members, and can be highly evaluated.From now on, I hope the filing ratio will fur-ther increase, without lowering again.

CME Curriculum

When the result of the CME program is

assessed from a quantitative viewpoint, afiling ratio of 100% will be most desirable.This could be achieved by making the CMEsystem obligatory.

However, what is important is the qualityof continuing medical education, that is, thecontents of the CME curriculum.

The JMA developed the CME curriculumin 1991, and has periodically revised it.

The CME curriculum should be practicaland helpful for each physician from theviewpoints of “improvement of quality inmedical treatment” and “assurance of patientsafety.”

The CME curriculum developed by theJMA addresses issues of two main Parts, PartI and Part II. Part I is related to clinicalscience which includes knowledge of bothhigh-frequency and serious diseases that willassist primary physicians to provide medicalcare.

Part II, on the other hand, includes “mind,attitude, and behavior as a doctor”, whichare important for clinical physicians. In otherwords, these issues cover a wide range fromhumanics, medical ethics, philosophy, law,economics, society, and welfare to assess-ment of medical quality. Thus it is Part II thatthe JMA regards as an important feature ofits CME.

To meet demands from a changing society,

90.0

80.0

70.0

60.0

50.0

40.0

30.0

20.0

10.0

0.0

73.0

64.260.6

58.054.8

50.5

47.644.0

40.737.0

33.2

30.6 28.624.0 25.6

33.1

70.5 68.8 66.562.2

59.852.8 52.851.3

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

53.3 57.059.9

45.140.5

47.1

57.561.6

70.7 74.4 75.4 76.4

64.7

41.1

39.8

47.743.1

60.7

69.668.666.863.2

56.252.4

Filing ratio (%)

(year)

TotalClinicsHospitals and others

Fig. 1 Transition of filing ratio

CURRENT AND FUTURE ISSUES IN CONTINUING MEDICAL EDUCATION BY THE JMA


206

the JMA has revised the Parts of the curricu-lum several times. Similarly, various learningstrategies and educational media have beendeveloped.

Promotion of Recurrent Education

Education for physicians should include theacquisition of skills and learning of effectiveattitudes in addition to medical knowledge.Conventional continuing education was oftenbased on attendance at lectures or academicconferences.

To acquire new medical or clinical skills,recurrent education with practical training isrequired. Here recurrent education meansparticipation-type work-study courses includ-ing skill practice performed intensively overa short period.

For example, permission for tracheal intu-bation has been recently granted to emer-gency life guards. In response to this, asample program for maintaining open air-ways was prepared so that a JMA membercan knowledgeably instruct an emergencylife guard to perform tracheal intubation in aprimary emergency situation.

Of course, this is just one example, andother examples of recurrent education withpractical training include ACLS, AED,cardiac echo, and abdominal echo. Suchskills cannot be acquired through lecturesonly, and practical training in a small groupis required.

Some local medical associations havealready conducted such continuing medicaleducation. I hope to see further diffusion.

Educational Workshops forSupervisory Doctors (Preceptors)

Another new strategy introduced for theCME system is educational workshops forsupervisory doctors (preceptors).

The medical education system in Japanhas been drastically changed over the pastfew years. Now many medical universities,colleges, and faculties entrust clinical train-

ing for medical students to local clinics.Moreover, clinical training became manda-tory in April 2004. The new clinical trainingsystem places emphasis on primary care, andrequires residents to receive local medicaltraining.

For this reason, even JMA membersengaged in community health care arerequired to help educate medical studentsand residents in any way possible. One caneasily imagine that educating medical stu-dents and residents will impose an additionalburden on JMA members who are busypracticing daily medical care.

However, every physician has a responsi-bility to foster young promising physiciansfor the future of the medical field. Asexpressed in the saying, “Teaching is learn-ing”, to teach someone, we also learn forourselves, which is the essence of continuingeducation.

At the same time, a closer relationship ispromoted between JMA members engagedin community health care and local hospitals,joined by the common objective of “medicaleducation.” An ideal hospital-clinic partner-ship can be established on this basis.

The first educational workshop for super-visory doctors was held by the JMA in July2003, and subsequently many workshopswere held by local medical associationsnationwide. There will be an additional num-ber of workshops planned in the future. Thisreflects the great interest of local medicalassociations in this issue.

Participation of JMA in Preparationof the National Examination forMedical Licensure

Another factor affecting the CME systemfor the development and improvement ofmedical education in Japan is to ask themedical colleges nationwide to submit draftsof questions for the national examination formedical licensure.

Recently, our national examinations formedical practitioners have been consider-

Hashimoto N


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ably improved and modified in many wayssuch as an increased number of questions, areview of the contents of questions, the set-ting of a pass/failure standard, the introduc-tion of a pooling system for exam questions,the collection of examination sheets, and thenotification of examination results. Publicsubmission of questions for the nationalexamination for medical licensure is one ofsuch improvements.

Though many medical colleges are askedto develop questions because tens of thou-sands of questions are required each year,there is still a demand for an even greaternumber of questions. Thus the JMA is con-sidering meeting this request as part of itscontinuing education program.

Progress of Educational Media

As various CME strategies evolve, educa-tional media used for the CME system havealso been developed.

Print media such as journals, books, andtexts as well as radio and television aregradually being pushed into the background,while the internet plays a vital and growingrole in the CME program.

Of course, conventional media includinglectures, seminars, academic journals, videos,and CD-ROMs still play a certain role.However, online CME courses which haveincreased in number partly supported bysponsorship from many companies havebeen taking a leading position.

Evaluation of CME

The JMA has often revised the curriculum,aims, and strategies of the CME program toimprove its quality.

The most important and difficult point ishow to evaluate the CME activities.

Evaluation is classified into two categories,based on purpose: formative and summativeevaluation. The purpose of formative evalu-ation is to assist a learner in his/her studyprocess by providing feedback.

In contrast, the summative evaluationaims to judge whether a learner reaches anacceptable level or not at the final stage ofstudy.

Since physicians are established profes-sionals, the widely held idea was that forma-tive evaluation which requires frequentfeedback was more suitable for CME thansummative evaluation which judged the finallevel of achievement.

In fact, the report issued by the CMEcommittee of the JMA in 1998 containedsuch a description.

However, drastic changes in society inrecent years have greatly affected socialdemands on medical care in many ways.Mass media such as newspapers and televi-sion often reports the occurrence of medicalaccidents and errors, cases questioning theethics of physicians, and hospital directorsbowing in apology.

There is not a physician in Japan who isnot concerned about the effects of suchreports. There is a tendency seen in parts ofsociety and mass media to join in criticism ofphysicians, and this arouses mistrust towardsmedical care.

The way to cope with these circumstancesmay be considered from the viewpoint ofcontinuing education.

The causes of recent medical errorsinclude, but are not limited to, a lack ofmedical knowledge on the part of physicians,low medical skill levels, and inappropriateattitudes toward patients.

Thus most medical errors are associatedwith knowledge, skill, or attitude, all of whichare covered by the CME curriculum. There-fore, promoting the CME system can be oneof the most appropriate actions to controlmedical accidents.

The principles of CME are “to providequality medical service for patients” and “toimprove medical services.”

I believe most JMA members are engagedin their CME activities with these principlesin mind. However, even if we conduct CMEbased on these principles and make further

CURRENT AND FUTURE ISSUES IN CONTINUING MEDICAL EDUCATION BY THE JMA


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efforts to develop effective programs throughthe feedback we receive from participants,society will never remain blind to frequentmedical accidents.

All these situations may have led the gov-ernment to its recent proposal for renewal ofmedical licenses. To resolve this situation, weneed to establish objective criteria for evalu-ation of CME within our organization, andpublicly advocate them.

In other words, society requires us in theCME system to employ summative evalua-tion rather than formative evaluation, whichcannot stand in the face of criticism fromsociety.

The problem is how to establish the crite-ria for summative evaluation.

Basically, evaluation means to measurewhether things are good or bad, and judgethem. Thus evaluation consists of two steps:measurement and judgment.

As a first step, CME results can bemeasured by totaling the number of unitsearned. For example, units can be earnedfrom attendance at lectures in one case, andfrom participation in recurrent education inanother.

However, the next step judgement of theresults may be a difficult task. How and bywhat criteria can we judge a physician whohas earned several dozens of units in the pastseveral years?

The lowest criterion may be CME accredi-tation by the JMA, and the highest, renewalof medical licenses. We cannot discuss medi-cal licensure lightly now, because it is anational qualification.

There are still many other issues to besolved. One of them is the handling of penal-ties imposed on those who are not interestedin joining the CME program, who repeatmedical errors, who show a bad attitudetoward patients, or who repeat such actions.This is expected to need further discussion inthe future.

The CME promotion committee for thisterm will study these problems in accor-

dance with the inquiry by Dr. HaruoUematsu, JMA President.

In particular, a mandatory CME programand the introduction of a renewal system formedical licenses are urgent matters we can-not avoid. The committee will also discussthe relationship between the JMA CME sys-tem and accredited specialty boards. I willreport the results at a later date.

Conclusion

The current and future issues for the CMEprogram of the JMA were discussed above.

A physician is a professional, which meanssomeone engaged in an occupation thatrequires highly specialized training andtalent. Those who are engaged in a profes-sion generally organize a group, establishtheir own constitutions and comply withthem, and educate each member of thegroup to improve their knowledge and skills.The organization thus established is auto-nomic in that it is voluntarily managed andcontrolled. It is this autonomy that is theessence of professionalism.

In this sense, we physicians should holdour autonomy as professionals in the highestesteem.

Professional autonomy means self-drivendecision making to assume the responsibili-ties of his or her selected profession.

In other words, the essential principles ofprofessional autonomy require that he orshe should display self-discipline and con-tinuously keep up-to-date with medicalknowledge and skills to fulfill the responsi-bilities of the profession selected.

The term, autonomy, can be traced toKant. He advocated, “reason, good con-science, and good will”. This is the very spiritthat is required in a physician.

Physicians as professionals should disciplethemselves based on good will, practicemedical care with a patient-centered atti-tude, and continue learning throughout theirlives.

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209JMAJ, April 2005 — Vol. 48, No. 4

*1 Honorary Director, Japanese Red Cross Medical Center, and Advisor, Japan Medical Association, Tokyo, Japan*2 Secretary, Study Group of Gene-Related Issues, Tokyo, JapanCorrespondence to: Yasuhiko Morioka MD, Japan Medical Association, 2-28-16, Honkomagome, Bunkyo-ku, Tokyo 113-8621, Japan.Tel: 81-3-3946-2121, Fax: 81-3-3946-6295, E-mail: [email protected] article is an updated and revised version of a paper published in the Journal of the Japan Medical Association, Vol.132, No.1, 2004, pages87–90.

Medical News from Japan

Introduction

With the recent progress of medical scienceand medical care, problems related to medi-cal ethics have become important issues ofpublic concern. This situation necessitates

that all professionals involved in medicineand medical care straighten themselvesout and promptly endeavor to improve theethical quality of their practice.

Medical ethics includes a wide range ofissues from bioethics to clinical ethics andvocational ethics. One of the issues requiring

“Medical Ethics”—Efforts of JAMS Specialty Societies in Japan—

JMAJ 48(4): 209–213, 2005

Yasuhiko Morioka,*1 Takeshi Motegi*2

AbstractThe principal purpose of medical specialty societies is the advancement and dissemination of scien-tific study, and thus they have been highly regarded as places for presenting research reports. Inaddition, specialty societies are now addressing social problems and the issues of physician’s ethicsin clinical practice with strong awareness of their social responsibility as professional associations,reflecting the increasing interest in research ethics and as a result of the fact that they are entrustedwith the responsibility for certifying specialist physicians.

Mainly based on the results of a questionnaire survey on the 97 specialty societies (as of March31, 2003) affiliated with the Japanese Association of Medical Sciences (JAMS), the present state andproblems of the actions of these societies addressing medical ethics issues were examined.

Of the 97 specialty societies, 32 had an ethics committee inside their organization. These societiesclarified their positions regarding ethics in research execution and presentation, as well as the ethicalproblems relating to organ transplantation, genetic testing, reproductive medicine, etc., to help improvethe ethical quality of members. Among others, the Japan Society of Obstetrics and Gynecology haslong endeavored to develop ethics guidelines in the field of reproductive medicine and ensure thatmembers comply with these guidelines.

The JAMS specialty societies are associations with voluntary membership, and their legal capabilitiesare limited. However, they have social responsibilities as professional associations, and they must strivefor improvement of the ethical quality of members. Since it may be difficult in some cases to reach aconsensus regarding ethical issues within a society, it is important to seek external cooperation.

Key words JAMS specialty societies, Ethics committee, ELSI,Japan Society of Obstetrics and Gynecology, Reproductive medicine

210 JMAJ, April 2005 — Vol. 48, No. 4

Morioka Y, Motegi T

particular emphasis is the roles played byassociations of professionals in various fieldsof medical science and medical care, i.e.,the Japan Medical Association (JMA)and the Japanese Association of MedicalSciences (JAMS) specialty societies (herein-after referred to as “societies”) in establish-ing and ensuring compliance with ethicalcodes of conduct.

While ethics is essentially an internal,private and non-mandatory matter, the actsand behavior of persons in medical care andresearch as part of their profession need tobe controlled under widely-accepted ethicalrules observed by every professional. Ethicalissues of particular importance are regulatedby national laws and administrative guid-ance, but such legal and administrative regu-lation has inherent limitations. Basically,professional associations should establishrules and enforce self-imposed control overethical issues.

In this situation, JMA and specialtysocieties have recently been clarifying theirpositions concerning ethical problems forthe public and endeavoring to improve theethical quality of members. This articleexamines how medical societies in Japan areaddressing ethical issues and discusses prob-lems in their endeavors.

Actions Concerning Ethical IssuesTaken by JAMS Specialty Societies

Main medical societies in Japan are affiliatedwith JAMS, which is an organization underJMA. As of March 31, 2003, there were 97affiliated societies (99 at the present count).Based mainly on the results of a question-naire survey conducted by the JMA secre-tariat, the actions of these societies address-ing ethical issues were examined.

1. Ethical principles and ethicalcommittees of societies

Of the 97 societies, 8 had announced codes ofethics. These societies and those having ethi-cal provisions in the articles of association

amounted to 22 societies.On the other hand, 32 societies had ethical

committees or equivalent, many of whichhad been established in recent years (Fig. 1).

Many societies are intended to serve asplaces for research presentation and aca-demic information exchange for the princi-pal purpose of promoting advancement anddevelopment of academic study. Hence, theytraditionally did not pay much attention to theissues of ethics in medical care and research.However, this situation has begun to change.The ethical, legal, and social issues (ELSI)related to medical research have become thesubject of intense argument. Societies relatedto clinical fields are urged to train certifiedphysicians and specialist physicians. Theamendment of legal regulation has enabledhospitals and clinics to announce practice inspecific specialties. Each medical societynow bears an important responsibility toguarantee the quality of physicians as spe-cialists for the public. Societies are nowdirecting much attention to the member’sacquisition of specialist knowledge andskills, as well as ethical issues.

2. Subjects covered by ethicalcommittees of societies

The subjects covered by ethical committeesvary from society to society. In an overview,these include (1) animal experiments, inparticular the welfare and protection of

7

6

5

4

3

2

1

0

Num

ber

esta

blis

hed

1970

19831984198519861987198819891990199119921993199419951996199719981999200020012002

…

Fig. 1 Number of ethical committees (or equivalent)in 97 JAMS specialty societies established ineach year

211JMAJ, April 2005 — Vol. 48, No. 4

MEDICAL ETHICS

laboratory animals; (2) use of autopsy organsand pathological specimens in research andeducation; (3) cerebral death and organtransplantation; (4) corpses in abnormalconditions; (5) psychiatric medicine andlaws, gender identity disorders, psychiatricresearch and human rights; (6) genetic test-ing, analysis of human genome and genes;(7) research in the field of congenital anoma-lies; (8) blood transfusion to Jehovah’s Wit-nesses; (9) reproductive medicine and assistedreproductive technology; (10) presentationof research reports; (11) sanctions againstmember’s tort; (12) recommending expertwitnesses; etc. Though not directly relatedto ethical issues, actions in response to theincreasing media reports of medical acci-dents have also been taken, including thesystem for accident reporting from members,establishment of safety measures commit-tees, and enhanced training for physiciansrepeating medical accidents.

As seen in the above, various societies arenow strongly interested in ethical issues,ensuring the member’s compliance withethical codes and making social statements.The most typical example of specialty soci-eties that have been faced with a demandingneed to address medical ethics issues may bethe Japan Society of Obstetrics and Gyne-cology. The following section will examineand review the activities of this society, anddiscuss the problems which it faces.

Activities of the Ethical Committeeof the Japan Society of Obstetricsand Gynecology

The Japan Society of Obstetrics and Gyne-cology (JSOG) has long had an ethicalcommittee within the Board of Directorsto discuss issues of reproductive medicine.Since it was reorganized as a separatecommittee in 1984, the Ethical Committeehas been issuing many opinions and guide-lines, and requesting members to complywith them (Table 1). These guidelines haveundoubtedly had a major influence on the

practice of many physicians, both membersand non-members.

One of the most notable disputes occurredin 1973, when Dr. K, a physician in MiyagiPrefecture, was found to have been mediat-ing the adoption of babies against the relatedlaws. He advised pregnant women, who didnot wish to have children for some reason,to avoid abortion, and issued false birthcertificates stating that the babies were bornto other women who wanted to foster thebabies. These babies were registered as thebiological children of these women and theirhusbands. This “true child” mediation caseattracted much publicity in the media.

In 1975, JSOG and its regional branchdismissed Dr. K from membership. Con-sequently, the Miyagi Prefectural Medical

Table 1 Notifications of Japan Society of Obstetricsand Gynecology (as of March 31, 2004)

• Opinions concerning “in vitro fertilization and embryotransplantation” (October 1983)

• Opinions concerning the research using human sperm,eggs, and preembryo (March 1985, revised January2002)

• On the “registration and reporting system” concerningthe “clinical implementation of in vitro fertilization andembryo transplantation” (March 1986)

• Opinions concerning whether and to what extent theorgans from dead fetuses and dead newborns may beused in research (January 1987)

• Opinions on fetal diagnosis of congenital anomalies, inparticular chorionic villus sampling in early pregnancy(January 1988)

• Opinions concerning the frozen storage of humanpreembryos and eggs and the preembryo transplanta-tion (April 1988)

• Opinions concerning the clinical implementation ofmicroscopic insemination (January 1992)

• Opinions concerning the safety of Percoll in X-Y spermseparation (August 1994)

• Opinions concerning “multi-fetal pregnancy” (February1996)

• Opinions concerning “artificial insemination by donorand sperm donation” (May 1997)

• Opinions concerning “the scope of clinical application ofhuman in vitro fertilization and preembryo transplanta-tion” and “pre-implantation diagnosis” (revised July 5,1999)

• Opinions concerning surrogate motherhood (April 2003)

212

Association revoked the designation underthe former Eugenic Protection Act (theresponsibility for designating physiciansunder the former Eugenic Protection Actand the present Maternal Protection Lawresides in prefectural medical associations;Article 14 of the Maternal Protection Law).Dr. K was prosecuted, and was fined for vio-lating the Medical Practitioners Law and formaking and using counterfeit authenticdeeds in 1978. Based on this criminal convic-tion, his physician’s license was suspended in1979. Dr. K appealed for the withdrawal ofthis administrative disposition, but the HighCourt and the Supreme Court dismissed hisappeal. However, Dr. K received much sym-pathy, as his actions were conducted fromthe standpoint of social justice to save thelives of fetuses (and newborn babies). Thisprompted the movement toward the cre-ation of the special adoption system, and thelegislature for special adoption (e.g., Articles817-2 to 817-11 of the Civil Code) wasenforced in 1988.

There was another old dispute on thelong-standing issue of artificial inseminationby donor (AID). The first case of the birth ofa child by means of AID in Japan took placeas early as 1949, and a limited number offacilities subsequently continued the prac-tice of AID. From the beginning, there werearguments both for and against it. WhileJSOG was considering this issue, it did notexpress its position for many years. AID hadbeen performed by connivance until JSOGfinally made an announcement to permit it in1997.

In 1986, a controversy was raised bythe media coverage that Dr. N in NaganoPrefecture performed multi-fetal pregnancyreduction. The problem of multi-fetal preg-nancy arose with the widespread use of invitro fertilization. At the time, the Associa-tion of the Japan Maternity Protection Doc-tors objected to fetal reduction, but JSOGdid not express its opinion. Although JSOGstated later in 1997 that the number ofembryo transplants in extracorporeal insemi-

nation should be limited to 3 or less to avoidmulti-fetal pregnancy, it withheld judgmentas to whether fetal reduction is acceptable ornot, and this issue remains unresolved today.

In 1998, the aforementioned Dr. N wasreported to have performed in vitro fertili-zation using donor eggs. JSOG consideredit a breach of the Society’s guidelines pub-lished in 1983, and immediately revokedthe membership of Dr. N. The President ofJMA supported this decision, but NaganoMedical Association did not revoke thedesignation under the Maternity ProtectionLaw. Recently, Dr. N promised to observethe Society’s guidelines, and his membershipwas restored.

Among the most recent incidents, Dr. O inHyogo Prefecture was dismissed from mem-bership of JSOG for conducting sex selec-tion using preimplantation diagnosis whichis against the JSOG guideline.

As the above examples indicate, therehave been many occasions in which newtechniques were used before the Societyexpressed its position and procedures wereperformed against the Society’s guidelines.JSOG has had major difficulties coping withsuch problems. While issues related to repro-duction pose delicate problems for physi-cians conducting diagnosis and treatment,even physicians and medical scientists spe-cializing in this field often find it difficult toreach a consensus on these issues. Becausethe member’s affiliation to the Society isvoluntary, there are limitations on the abilityof the Society to enforce its guidelines. Thepast experience of JSOG provides manyinsights that may help improve the capabilityof other professional associations in resolv-ing ethical issues.

Conclusion

As associations of medical specialists, spe-cialty societies have been playing the role ofproviding places for research presentationprincipally for the sake of the advancementof academic study. However, the situation

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213

has changed as a result of the facts that theimportance of research ethics has becomeemphasized and medical societies in clinicalfields are now engaged in the system for cer-tified physicians and specialist physicians.Medical Societies achieving a certain level ofquality are now entrusted with the responsi-bility for certifying the qualification of physi-cians that can announce practice specificspecialties. As these societies must guaranteethe quality of specialist physicians for thepublic, they are suddenly being faced withthe significant need for ensuring the mem-ber’s performance in the acquisition ofmedical knowledge and skills, as well as com-pliance with ethics.1

On the other hand, there still remainmany problems and issues with regard to thedevelopment of the specialist physician sys-tem in Japan.2 And as exemplified by theissues in reproductive medicine, ethical

MEDICAL ETHICS

problems often pose difficulties in a consen-sus being reached among members. Ques-tions are also raised over the effectiveness ofthe professional association’s self-imposedregulation in ensuring the compliance withethical codes. To deal with these problems,various schemes may need to be devised andutilized, such as seeking assistance fromthird-party specialists outside the medicalsociety. Each society should strive to makeitself a transparent organization trusted bythe public.

The abstract of this article was presentedas the report of “Bioethics and Law in thePromotion of Life Science and Technology”(representative researcher: Saku Machino,Prof. of Sophia Law School), a study sup-ported by Special Coordination Funds forPromoting Science and Technology (fiscal2003–2004) of the Ministry of Education,Culture, Sports, Science and Technology.

References

1. Oshima S. What should be done by medical societies as special-ist professional associations. Nippon Iji Shinpo. 2004;4165:73–76. (in Japanese)

2. Ikegami N. The role of specialist physicians in the medicalcare system of Japan. Sogo Rinsho. 2003;52:3125–3130. (inJapanese)


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