Clinical Practice Guidelines in Japan25 CPGに対応する“new ” と“ update ”分(約40編)...
Transcript of Clinical Practice Guidelines in Japan25 CPGに対応する“new ” と“ update ”分(約40編)...
日本の診療ガイドラインの作成と活用の現状
Development and Implementation ofClinical Practice Guidelines
in Japan
(財)日本医療機能評価機構東京女子医科大学
山口 直人Naohito Yamaguchi
MHLW Initiative
Ministry of Health, Labor and Welfare (MHLW) took the initiative to implement the evidence-based medicine in Japan• Primarily aiming at quality assurance• But also, economical incentive
working
MHLW Initiative 2
MHLW started supporting the development of clinical practice guidelines (CPG) in 1999.• To implement EBM in Japan• 23 diseases were selected primarily
based on disease burden (but also with some political pressures)
Selected diseasesAcute myocardial infarctionHypertension Allergic rhinitisBronchial asthmaCataractDiabetes mellitusAlzheimer dementiaBrain infarctionBrain hemorrhageSubarachnoid hemorrhageGastric ulcerAcute pancreatitisAcute cholecystitis
Rheumatoid arthritisFracture of the femurLumbar disc herniaLow back painBenign prostate hypertrophyIncontinence Urinary stoneGastric cancerLiver cancerLung cancerBreast cancerProstate cancer
Implementation of CPG
Japan Council for Quality Health Care (JCQHC) launched in 2002 a medical information service to disseminate CPG in Japan.Financial support by MHLWInternet-based distribution of CPG and related information
MINDS takes into consideration:
Stands neutral, avoiding influence of government and providersBased on sound evidenceSupports both healthcare professionals and patientsProvides information useful for practiceProvides up-to-date informationAppreciates feedback from users
CPG on MINDS
Gastric ulcer ◎Acute myocardial infarction ◎Subarachnoid hemorrhage ◎Bronchial asthma ◎Cataract ◎Benign Prostate Hypertrophy ◎Incontinence ◎
Acute pancreatitis ○Diabetes mellitus ○Lung cancer ○Brain infarct ○Brain hemorrhage ○Alzheimer dementia ○Hypertension ○Fracture of the femur ○Lumbar disc hernia ○
◎ For healthcare professionals and for patients○ For health care professionals
MINDS ContentsFor healthcare professionals• CPG• MINDS PLUS (contents provided by MINDS)
• MINDS Abstract (of latest RCTs)• Cochrane CDSR Abstracts translated into Japanese• CPG reviews (of oversea CPGs)• Topics
For patients/public• CPG• MINDS PLUS
• What’s in CPG for healthcare professionals• Medical terminology glossaries
Improving Care by Improving Care by Implementing Implementing
GuidelinesGuidelinesThe New Zealand ExperienceThe New Zealand Experience
Catherine MarshallChief Executive, NZGG
Honorary Patron,Guidelines International Network
New Zealand and JapanNew Zealand and Japan
• Island nations bordering the Pacific Ocean
• Started developing evidence-based guidelines in 1990s
• MINDS and NZGG independent from Government
• Guidelines covering similar topics:– Cardiovascular diseases, stroke, low back pain,
prostate cancer, femur fracture, breast cancer
OutlineOutline
• Guideline development in New Zealand
– Development processes
– Implementation processes
– Designing tools to support the guidelines
– Redesigning systems and process
• Guidelines International Network
NZGG Promotes Culture NZGG Promotes Culture ChangeChange
Improving outcomes for consumers by:
• reducing the gap between optimum best practice based on evidence – and current practice
• using therapies known to be effective
• providing up-to-date information about options and outcomes for clinicians and consumers and
• identifying effective care!
Guideline Development PrinciplesGuideline Development Principles
1. Guidelines focus on consumer outcomes
2. Link best evidence and strength of recommendations
3. Synthesis of evidence strongest available
4. Team of multidisciplinary professionals and consumers
5. Guidelines flexible and adaptable for local conditions
Guideline Development PrinciplesGuideline Development Principles
6. Guidelines consider resource constraints
7. Guideline development includes dissemination and implementation plans
8. The usefulness & impact of guidelines should be evaluated
9. Guidelines should be revised regularly
Essential StepsEssential Steps• Identifying evidence - practice gaps
• Scoping and questions
• Literature searching, selection and critical appraisal
• Develop evidence tables
• Form clear action focused recommendations
• Consultation with stakeholders to get buy-in
Guideline Development TeamGuideline Development Team• Balanced and representative
• Nominees from:–professional colleges
–stakeholder organisations
–consumers
–Maori and Pacific peoples
• Geographic representation
Editorial IndependenceEditorial Independence
• No trade names used
• All funding sources for guidelines are made explicit
• NZGG retains copyright and promotes wide public access to the guideline information
Evidence Trumps Opinion
Guideline development process*Guideline development process*
Critical appraisalQuestions
Guideline structure
Literature search
Selection of literature
GDT sign-off draft
Supporting documents
Refine draft guideline
Evidence tables
Search strategy
Endorsement
Selection criteria
Consultation feedback
Audit indicators
Scoping
Recommendationsand draft guideline
Consultation
Editorial process Guideline sign-off
: Meetings
Practice Gaps
ImplementationImplementation
* Based on a CBO model
Is the Judgment Considered?Is the Judgment Considered?
Does the evidence apply to NZ conditions?
• Volume of evidence
• Consistency of message
• Applicable to NZ (cost, availability, cultural suitability)
• Clinical impact (will it lead to improvements?)
ImplementationImplementation
1. Awareness campaign
2. Education programme
3. Dissemination programme
4. Implementation programme
5. Evaluation programme
SWOT AnalysisSWOT Analysis
• Barriers to implementation
• Workforce requirements
• Cost implications
• Consider views of each audiences
• Identify incentives that could encourage uptake of the guideline
NZGGNZGG’’s Implementation Plans Implementation Plan• Identify key themes to promote
• Identify the range of audiences – and find out how they want to learn about the messages– Primary care practitioners - Specialists
– Allied health practitioners - Consumers and the media
– Policy makers and funders - Software vendors
– Other businesses eg gymnasiums,
– Pharmaceutical companies, publishing houses
Quality dimensions for the New Zealand Quality dimensions for the New Zealand health and disability systemhealth and disability system
•
Improving Quality, Ministry of Health, NZ, 2003
Individual NeedsIndividual Needs
• Trusted reliable, evidence-based information
• Understandable information on risks, benefits and options
• Formats that are clear and concise
Team ChangesTeam ChangesSelf Harm and Suicide Prevention Project
• Improve consumer experience when using emergency department, Maori and mental health services
• Improve service co-ordination and collaboration
• Give clinicians skills that they can transfer to other quality improvement initiatives
• Create and sustain a community of leaders who can implement evidence based change in clinical practice.
Making It RelevantMaking It Relevant
• National targets derived from the guidelines
• Local objectives to meet national targets
• Map consumer experiences to identify system blocks
• Plan-Do-Study-Act Cycle
• Maori Advisory Group will provide cultural oversight
Draft National TargetsDraft National TargetsAccess
• 100% of people attending EDs with self harm or suicidality should be seen within 1 hour by a clinician skilled in conducting mental health and risk assessments.
Assessment
• 100% of people presenting (to any of the services) will have a documented assessment that incorporates and assessment of psychosocial stressors, a cultural assessment, a screen for mental illness and subsequent risk assessment
Discharge
• Whenever a person is discharged from any of the services, they and their whanau/ significant others should be provided with a written copy of their discharge plan. A copy will be sent to all others involved in their care.
NZGG Support for HospitalsNZGG Support for Hospitals
• Mentoring/ project supervision/evidence dissemination/ relationships
• Two day workshop for participants
• Monthly teleconferences
• Website for collecting stats, sharing information
• Visits by project staff to hospitals
NZ Health StructureNZ Health StructureMinistry of Health
District Health Board DHB DHB (21)
Primary Health PHO Hospitals
Medical
Centres
Maori Health Services
Hospitals
System ChangesSystem Changes
• Ministry of Health contracts with District Health Boards (DHBs) to implement guidelines
• District Health Boards set payments for Primary Health Care Organisations (PHOs) to adopt guideline recommendations
Policy and Funding IssuesPolicy and Funding Issues
• Get policy agencies involved early
• Provide policy makers with opportunities to comment:
- actively discuss the implications of the recommendations
– assess the costs and implications of the recommendations (eg screening issues, recommendations for new drugs)
NZGGNZGG’’ss Work AheadWork Ahead• Traumatic brain injury (and other accident related g/ls)
• Management of burns in primary care
• Cancer control guidelines including:– Management of abnormal cervical smears
– Melanoma
– Providing supportive care for people with cancer
• Complementary therapies
• Birth/ antenatal care
• Updates of CVD and asthma guidelines
International IssuesInternational Issues• Adaptation of existing guidelines
• International standards for:– evidence tables, updating processes
– guideline structure
– guidelines designed for electronic decision support
• Greater consumers involvement
• Increasing emphasis on herbal and traditional medicine
To Change Practice TomorrowTo Change Practice Tomorrow……• Prepare well and know the evidence
• Involve the relevant people – locally and internationally
• Study the main difficulties – and develop strategies linked to those difficulties (within budget)
• Define indicators for measuring success and monitor progress
• Enjoy making patients’ care more effective, efficient, safe and friendly!*
*R Grol, Grimshaw J, Lancet 2003; 362
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Mindsの3つの部会1. 診療ガイドライン選定委員会
部会長:福井次矢 (聖路加国際病院)2003.6 -
2. 医学文献評価選定委員会
部会長:森實敏夫 (神奈川歯科大学)2003.6 -
3. 医療技術評価部会
部会長:津谷喜一郎 (東京大学大学院)2005.4 -
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Minds 医療技術評価部会
目的
国内外の診療ガイドライン等の各種医療情報の収集、評価、提供に関する必要事項について審議し、担当理事に諮問すること。
現在の活動
(1) The Cochrane Review (CR)のabstractの日本語訳とMinds webへの収載
(2) 複数の診療ガイドラインのレビュー
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Minds 医療技術評価部会
メンバー
伊藤澄信(独立行政法人国立病院機構)
上原鳴夫(東北大学)
北澤京子(日経BP社)
津谷喜一郎(東京大学大学院)- 部会長
長谷川友紀(東邦大学)
古川壽亮(名古屋市立大学)
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Minds 医療技術評価部会
会議
第1回.2005. 5.13 第2回.2005. 6.17第3回.2005. 7.20第4回.2005. 9. 5第5回.2005.11. 2第6回. 2006. 1.28
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Abstract of the Cochrane Reviewの日本語訳
特徴・The Cochrane Library (CL)は年4回改訂され,New(約90編)とUpdate (約50編)、合計約140編が改訂ごとにでる。
・time lagへの対応
・作業量への対応 (全てか or 25 (23+2) CPG対応か?)
Step-wise作業step 1. 最新分: CL 2005 issue 4 (2,524編)
25 CPGに対応する“ new ” と“ update ”分 (約40編)step 2. 同
25 CPGに対応する既存分(約100編)step 3. 「過去」分
CL 2004 issue 4 の素訳 (2,204編)step 4. 残り: CL 2005 issue 4 の25 CPGに対応していないもの
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例:Airways GroupでのCR数の動き
ICD-10大分類 New Update 喘息ガイドライン関連のレビュー
X 呼吸器系の疾患 2 Airways 10 8 New 5, Update 4
Collaborative Review Group (CRG)No.Complete Review
2005 issue 4
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翻訳の品質管理システム
1.下訳業者の選定・ 公募要綱の作成・ 選定クライテリアの作成・ 翻訳質評価チェック表の作成
レビュー・アブストラクト10篇について試験翻訳の質評価
2.訳語の標準化3.Minds-HTA側の訳のチェック
・ チェッカー13人
4.最初のlotは2006年3月末に公開予定
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用語標準化に用いたreferences
1.クリニカル・エビデンス Issue 9 日本語版.日経BP社, 2004 - の用語解説 (glossary)
2.日本医学会医学用語管理委員会(編).日本医学会医学用語辞典:英和, 第2版, 南山堂, 2001
3.共同通信社(編著). 記者ハンドブック:新聞用字用語集, 第10版, 共同通信社, 2005
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過去分:CL 2004 issue 4 の素訳 (2,204編)
• ある業者に翻訳委託
• 納品物の翻訳の質評価・ランダムに10篇を選択
・Minds-HTAの2人が独立に評価
• 翻訳のやり直しを指示
• 再納品
• 公開に向けての対応・Disclaimerをつける(試験翻訳)
・原文といっしょに公開
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JANCOCでの翻訳の取り組み
1.1997年JANCOC参加者を中心にworking group2. ボランティアによる翻訳・データ管理・事務作業を
行った。
3.1998年 issue 4まで翻訳版作成、公開• 国立医薬品食品衛生研究所のwebで公開
• 2001年4月より国立公衆衛生院に移行http://www.niph.go.jp/toshokan/cochrane/JP/REVABSTR/JP/abidx.htm
4. 1999年 issue 1より翻訳作業中断• 英語版での追加、更新は年間100件程度
• 1999年issue 2より抄録記載方法の全面改訂あり
• ボランティアによる翻訳とworking groupでの編集作業は不可能
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The Cochrane Reviewの
各国語翻訳版
1.中国語版・ 一時期存在した。
・ 現在、Wiley社と翻訳権の再交渉中
2. スペイン語版・El Centro Cochrane Iberoamericanoのwebに
・ a Biblioteca Cochrane Plus
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• Disclaimer文案:
ここにご紹介する日本語訳は、コクラン・ライブラリ2004年issue 4に収載された、コクラン・システマティック・レビュー・アブストラクトの翻訳版です。
あくまでも試験的翻訳を行った素訳版として公開するものであり、翻訳の正確性や質が保証されたものではありません。そこで原語の英文も見れるようにしてあります。
上記の点ご理解のうえ、ご利用くださいますようお願い申し上げます。
過去分の日本語訳公開案
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画面表示案
過去分の日本語訳公開案
ここにご紹介する日本語訳は、コクラン・ライブラリ2004年issue 4に収載された、コクラン・システマティック・レビュー・アブストラクトの翻訳版
です。あくまでも試験的翻訳を行った素訳版として公開するものであり、翻訳の正確性や質が保証されたものではありません。この点ご理解のうえ、ご利用くださいますようお願い申し上げます。
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Step 1: 25CPG対応のnew and updateStep 3: 「過去分」
Step 3 2004 issue 4 (2,304 編)
Step 1 2005 issue 4 25 CPG 対応(約40編)
1998 issue 4 by JANCOC