2010JICA Sapporo harada02 [互換モード]

1

2010JICAtraining course (2010.12.16) at SCIPH1

JICA: Support for the Establishment of a Neonatal Screening System forMiddle East Region, FY2010

(2010.12.16) Sapporo City Institute of Public Health

Neonatal Screening Program- Establishment, Evaluation, and Follow-up Survey -

Additional Slides

HARADA Shohei, M.D., Ph.D.

Head of the Division of Clinical Practice Policy,

Department of Health Policy,

National Research Institute for Child Health and Development

Neonatal Screening Research and Development Center of

Japan Public Health Association (JPHA)

2008JICAtraining course (2008.12.8) at SCIPH2 3

•Millennium Development Goals (MDGs)•Goal 1: Eradicate extreme poverty and hunger•Goal 2: Achieve universal primary education•Goal 3: Promote gender equality and empower women•Goal 4: Reduce child mortality rate

•Target 4A: Reduce by two-thirds, between 1990 and 2015,the under-five mortality rate

•Goal 5: Improve maternal health•Goal 6: Combat HIV/AIDS, malaria, and other diseases•Goal 7: Ensure environmental sustainability•Goal 8: Develop a global partnership for development

• MDG 1 - hunger and poverty• Malnutrition

• Child labor

• MDG 4 - reduce child mortality• MDG 5 - improve maternal health

• MDG 6 - combat disease• MDG 7 - environmental sustainability

• Deforestation

• Runoff fertilizer water pollution

Tobacco and MDGs

Meeting on a Training Network on Child and Adolescent Health and TobaccoControl in the Western Pacific9-10 December 2010

5 |

Overview on tobacco control:Overview on tobacco control:Implications for child and adolescent healthImplications for child and adolescent health

Overview on tobacco control:Overview on tobacco control:Implications for child and adolescent healthImplications for child and adolescent health

Dr Susan MercadoDr Susan MercadoTeam LeaderTeam Leader

Tobacco Free InitiativeTobacco Free InitiativeWorld Health OrganizationWorld Health Organization

Western Pacific Regional OfficeWestern Pacific Regional Office

6


7 |Meeting on a Training Network on Child and Adolescent Health and TobaccoControl in the Western Pacific9-10 December 2010

8 |

2 peopledie each minute from atobacco-related diseasein the Region.


9 |

Number of smokers in

the Western Pacific:

430 million

2


10 |

Tobacco use is a

paediatric disease.

80-90% of smokers initiate

use before the age of 18.


11 |

4,000 chemicals, 60 known carcinogens


12 |

13.8%youth 13-15 yearscurrently smokecigarettes in the

Region


13 |

64%youth 13-15 years

exposed to secondhand smoke inpublic places


14 |

50%youth 13-15 years

old are exposed tosecond hand

smoke at home.

Social

StrategiesScientific

Knowledge

Political

Will

Professor Seiji Yamaguchi, M.D., Ph.D.Department of Pediatrics, Shimane UniversityThe president of Japanese Society for Mass-Screening

NewbornScreening

ImmunizationInfant HealthCheck System

Child Health

Governmental Policies

The concept proposed by Professor Yamaguchi, who is the chair of the research project team

NewbornScreening

ImmunizationInfant HealthCheck System

Child Health

Governmental Policies

TobaccoControl

The concept modified by Dr. Harada

3


The closing ceremony of 7th APRM of ISNS at Bali, Indonesia, Oct. 201021

The closing ceremony of 7th APRM of ISNS at Bali, Indonesia, Oct. 2010

Dr. Fukushi

Dr. Hannon

Dr. Aman B. PulunganChairman of the Meeting

Dr. Pass

Dr. Therrell

Dr. Padilla

Dr. Torresani


Dr. Carmencita D. Padilla, Director, Newborn Screening Reference Center,National Institute of Health, University of the Philippines ManilaMembers of Newborn Screening Center of the Philippines

24

7th ASIA-PACIFIC REGIONAL MEETINGof the International Society of Neonatal Screening (ISNS)

3-5 October 2010 Discovery Kartika Plaza, Kuta Bali, Indonesia

Country ReportFrom Japan

Shohei HARADA, MD, PhDDepartment of Health Policy,

National Center for Child Health and Development,Tokyo JAPAN

Neonatal Screening Research and DevelopmentCenter, Japan Public Health Association

Name of country: JapanSize of country: 377,914 km²Population: 127,288,419Annual number of newborns:1,081,383 (2008)

Research Institute Medical Center

National Center for Child Healthand Development, Tokyo JAPAN

4

S. Harada (2009.7.10) 検査技術者研修会

1980 1990 2000 2010

Sapporo

JAPAN

Hokkaido

City Town MHLWPTCity ？

Hokkaido

PediatricianScreeningLaboratory Pediatrician LTFU

QA

Today’s Take Home Message

Metabolic

(End

ocrine)A

bnormality

TypicalClassical Atypical

PartialTransient Non

disease

How to define a condition ?

Cut off 1 Cut off 2 Cut off 3

False positive rate

(Modified Dr. Loboer’s PLENARY 6)30

Structure (Standard ) of Screening in Japan

Notificationof results

Prefectural and city governments/

government designated cities

Implementation guideline for testsof congenital metabolism

abnormality, etc.

Laboratory for screening

Pregnant women,families

Medical institutionfor detailed tests

Enlightening and publicizing of thenecessity of receiving tests throughmaternal and child healthhandbook and mothers’ classes

Requestfor tests

Liaison council forscreening

Consultantphysician

Filter paperblood

Medical institutionfor blood sampling

Request fordetailed tests

Informationsupply

Publicizing thescreening system

S.Harada (2008.11.12)富山県民会館

Neonatal screening in Japan

Disease Analytes Treatment IncidencePhenylketonuria

（ＰＫＵ）

Phenylalanine Low-Phe Diet １：93,345

Maple Syrup Urine

Disease （ＭＳＵＤ）

Leucine Diet １：670,702

Homocystinuria Methionine VitB6, Diet １：796,161

Galactosemia Enzyme activity

Galactose

Diet Type 1

１：934,192

Congenital

Hypothyroidism

TSH (all labs)

free T4 (few labs)

Thyroid hormone

replacement

１：3,000～3,500

Congenital adrenal

Hyperplasia (CAH)

17-hydroxy-pro-gesterone（17-OHP)

Cortisol

florinef

１：15,800

S.Harada (2008.10.25)MS基礎研修会

Wilson JMG, Jungner G. Principles and Practice ofScreening for Disease. WHO Chronicle 1968;22(11):473.

１．The condition sought should be an important health problem.

２．There must be an accepted and effective treatment for patients with thedisease, that must be more effective at preventing morbidity when initiated inthe early, asymptomatic stage than when begun in the later, symptomatic stages.

３．Facilities for diagnosis and treatment should be available.

４．There must be an appropriate, acceptable, and reasonably accuratescreening test.

５．The natural history of the condition, including development from latent tomanifest disease, should be adequately understood.

６．The cost of case-finding (including diagnosis and treatment of patientsdiagnosed) should be economically balanced in relation to possible expenditureon medical care as a whole.


Recent results of neonatal screeningfor IEMs in Japan

Year Annual birth Annual test % ReportedCases

1977-2002

34,862,172 33,313,090 95.6 4,221

(His 2,200)

2003 1,124,755 1,183,571 105.2 70

2004 1,099,477 1,161,382 105.6 71

2005 1,064,003 1,118,428 105.1 126

2006 1,091,323 1,150,337 105.4 92

2007 1,092,319 1,166,739 106.8 101

2008 1,081,383 1,163,190 107.6 125

Total 41,415,432 40,256,737 97.2 4,806


Recent results of neonatal screeningfor congenital hypothyroidism in Japan


1979-2002

34,862,172 29,985,830 95.4 7,869

2003 1,124,755 1,183,584 105.2 465

2004 1,099,477 1,157,350 105.3 590

2005 1,064,003 1,115,572 104.8 568

2006 1,091,323 1,151,470 105.5 577

2007 1,092,319 1,157,382 106.0 580

2008 1,081,383 1,154,185 106.7 606

Total 41,415,432 40,256,737 97.2 11,255S. Harada (2009.7.10) 検査技術者研修会

Incidence of CH in Japan(Statistics from the Ministry of Health, Labour, and Welfare)

0

1000

2000

3000

4000

5000

6000

7000

8000

1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

Incidence

1 in 5,700 in the early 1980s.

1 in 3,900 in 1989 and in 1990


0 5000 10000 15000 20000 25000 30000 35000

1

4

7

10

13

16

19

22

25

28

31

34

37

40

43

46

49

52

55

58

61

Reported incidence of CH by each local governments (2007)（Statistics by the Ministry of Health, Labour and Welfareof Japan）

5


Recent results of neonatal screeningfor congenital adrenal hyperplasia in Japan


1988-2002

18,084,188 17,317,113 96.8 1,098

2003 1,124,755 1,183,571 105.2 57

2004 1,099,477 1,161,382 105.6 51

2005 1,064,003 1,118,428 105.1 64

2006 1,091,323 1,150,337 105.4 58

2007 1,092,319 1,166,739 106.8 76

2008 1,081,383 1,163,190 107.6 49

Total 41,415,432 40,256,737 97.2 1,453S. Harada (2009.7.10) 検査技術者研修会

Results of neonatal screening for congenitalhypothyroidism in Japan.

Presented at Hardelot, France in Sep.1993

Period No.ofscreened

No.ofCH

Incidence Methods

1979-1984 7,429,073 932 1:7,971 1984.8:RIA(87%),

EIA(13%)

1985-1987 4,128,218 675 1:6,116 1986.4:RIA(66.7%),

EIA(33.3%)

1988-1991 5,015,020 1,185 1:4,232 1988.10:RIA(44.5%),EIA(22.2%),

ELISA(33.3%)

1991.4:RIA(5.7%),ELISA(94.3%)

Total 16,572,311 2,792 1:5,936

0

10

20

30

40

50

60

1988 1992 1996 2000

Co-operation for LTFU by localgovernments（black：refusal）


Recent results of neonatal screeningfor congenital hypothyroidism (CH) in Japan

Year Annual birth Missing

LTFU data

CH Incidence

1994 1,233,072 17.5% 505 1 in 2,442

1995 1,187,067 17.5% 514 1 in 2,309

1996 1,206,551 24.1% 416 1 in 2,903

1997 1,194,510 26.7% 544 1 in 2,197

1998 1,199,183 29.3% 782 1 in 1,534

1999 1,184,302 38.5% 536 1 in 2,208

Total 7,204,685 25.9% 3,266 1 in 2,206

Development of theneonatal screening forcongenital hypothyroidismin Japan

Jun 1978 to Oct 1979

to Apr 1980

to Oct 1980

Type of NBS:National screening programs,but operated by each localgovernments (47 prefecturesand 18 big cities)


Annual numbers of low birth weightinfants (by Professor Kusuda)

0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

20001990 (year）0

2

4

6

8

10

12

14

16

LB

WI

(10,0

00_

rate

%)

Total birth

LBWI

Birth rate of LBWI

To

tal

bit

rth

(millio

n)


Barriers to screening andcurrent approaches to overcoming


002 2 35 10

21 15 11 17 7

5 4 20 6 12 6

6 6 26 4 8 3

0% 20% 40% 60% 80% 100%

2006

1994

1991

1981

Standardization of cutoff level of TSH in firstdried blood specimen on neonatal screening

for congenital hypothyroidism in Japan

None 80 50 40 30 30>

6

0% 20% 40% 60% 80% 100%

Female50_59

Female40_49

Female30_39

Female20_29

Male50_59

Male40_49

Male30_39

Male20_29

Have you ever known about implemenation ofnewborn screening in Japan?

IKnowAboutNBS Idon'tKnowAboutNBS

0% 20% 40% 60% 80% 100%

Female50_59

Female40_49

Female30_39

Female20_29

Delivery NoDelivery

Female>>>Male

Question：Do you know the nationwide neonatal screening in Japan?

Most of themDon’t Know

Mothers>>>>Non-pregnant women

A. ‘Personal data’ B. ‘Availability of consent’

C. ‘Progress in medicine’

Fig. 1 Fujii C. et al.

0 50 100 (%)

48.0

40.0

42.1

54.9

52.0

47.1

65.9

JSOG member

JSMmember

JPS member

NCCHD personnel

KUH medical staff

JPA member

Members of the public

28.6

20.0

14.9

17.6

49.0

50.3

14.7

0 50 100 (%)

JSOG member

JSMmember

JPS member

NCCHD personnel

KUH medical staff

JPA member


0 50 100 (%)

59.2

57.5

68.4

35.2

48.0

7.8

23.0

JSOG member

JSMmember

JPS member

NCCHD personnel

KUH medical staff

JPA member


S.Harada (2008.11.11)富山県医師会

Population statistics for current 100 years in Japanhttp://www1.mhlw.go.jp/toukei/kjd100_8/index.html#data

Cambodia 88 male 54.2

China 31 male 70.7

Infant mortality rates

Live birth rates

Daeth rates

S.Harada (2008.10.25)MS基礎研修会ＳＡＧＥ http://www.tokyo-eiken.go.jp/SAGE/yosoku-j/Japan/all_m.html

Spanish flue

Decrease of DeathsIncrease of Life expectancy

AgingLife-style disease

CancerEmerging diseaseAccident, Suicide

Total death numbers from 1900 to 2000 in Japan

MaleFemale


Agenda and future goals ofNeonatal screening in Japan

・Increasing numbers of LBWI・Iodine-containing disinfectants・Inappropriate long-term follow-up・storage and usage of residual dried blood spots・Introduction of MS/MS screening


Long-term follow-up system forscreened positives in Japan

Localgovernment

ScreeningLaboratory

Obestetrician（Blood collection）

RefferedMedical center

Research Institute forChild Health and Development

１．money

4. report

２．collection

３．result

５．Request forMedical examination

６．result

７．refferal

・Initial data from SLs・Positives from LGs ・Secondary data from SLs

・Data from medical centers

Reporting・MHLW・Academic society・Task force・Web site

7

S.Harada (2009.12.01)国立環境研 S.Harada (2009.12.01)国立環境研

Dr. Bradford L. Therrell, who is the Director of the National Newborn Screening andGenetics Resource Center (USA).

Dr. W. Harry Hannon, who is the Emeritus Chief of Newborn Screening Branch at CDC.Dr. Kenneth Pass, who is the President of the ISNS.

Newborn Screening System- Six Parts-

Education Screening

Evaluation Follow-up

DiagnosisTreatment

Management

“ not just a laboratory screening test “ by Dr. H. Hannon

Continuous Quality Improvement(CQI)

• Periodic audits – Week link analysis

• “Missed cases” – Gaps in the system

• False positive rate – Refining cutoffs

By Dr. H Hannon (CDC, USA)

S.Harada (2009.12.01)国立環境研

8

Dr. Dianne Webster, who is the director of New ZealandNewborn Screening


Barriers to screening

Pediatrician

Perception

Cost

Health benefits

KnowledgeAwareness

Acceptability

Test factors

Parental


Ms Vernonica Wiley, Secretary-Treasurer of the ISNSNSW Newborn Screening Programme, Australia

The importance of registry in Newborn Screening(by Dr. Veronica Wiley)

• Survey the literature - determine assay

• Assay samples with proven disorder

• Assay samples in a pilot program

• Analyse results from pilot andretrospective samples

• Determine percentile for cut-offdepending on overlap of patient groups

Establish Cut-off Values

9


S.Harada (2009.12.01)国立環境研 S.Harada (2009.12.01)国立環境研

Thank you for your attention!

Smoke-Free World for Children

Documents

2010JICA Sapporo harada02 [互換モード]