1123-临床指南的应用与意义课件1.ppt

1、“The conscientious，explicit,and judicious use of the best evidence in making decisions about the care of individual patients”D.L.Sackett,BMJ.1996“Putting EBM into context in the current practice of medicine:the science and art of medicine”Dan Mayer,EBM.2004 A medical guideline,clinical guidelineA me

2、dical guideline,clinical guideline,clinical protocolclinical protocol or clinical practice clinical practice guidelineguidelineHaynes RB,Sackett DL,Gray JM,Cook DJ,Guyatt GH.Transferring evidence Transferring evidence from research into practice:1.The role of clinical care research evidence from res

3、earch into practice:1.The role of clinical care research evidence in clinical decisions.in clinical decisions.ACP J Club 1996;125(3):A14-6.Foreground questionBackground question Year of clinical experience%建立在专家意见基础上有推荐意见，缺乏证据基础指南制定过程简单快速可靠性不能保证就某一问题给专家组提供相关证据文献专家组就文献进行评价经讨论得出共识指南制定者特别说明某种干预措施的获益、危害

4、、花费，尽可能用科学证据和公式分析方法，明晰估计各种结局的概率分析方法复杂，难以操作确定指南拟解决问题的重要性及制定指南的必要性和适用范围成立专门小组，确立制定指南的规范程序全面收集资料系统分析，对证据分级依据对证据的客观评价结果，提出推荐意见和推荐强度组织小组意外的专家对指南评审修改发布指南定期更新 资深专家组制定评估/标准/使用范围/医疗资源与费用/可操作性/地域及文化背景Brouwers M,Kho ME,Browman GP,Burgers J,Cluzeau F,Feder G,Fevers B,Graham ID,Hanna SE,Makarski J,on behalf of t

5、he AGREE Next Steps Consortium.Performance,usefulness and areas for improvement:Development steps toward the AGREE II Can Med Assoc J.2010,182:1045-528;E472-78http:/www.agreetrust.org/agree-ii/DOMAIN 1.SCOPE AND PURPOSE DOMAIN 1.SCOPE AND PURPOSE 范围与目标范围与目标1.具体描述指南的总体目标和准则2.具体描述指南涵盖的健康问题3.专门描述应用指南所适

6、合的人群(患者、公众等)DOMAIN 2.STAKEHOLDER INVOLVEMENT DOMAIN 2.STAKEHOLDER INVOLVEMENT 涉及利益相关者涉及利益相关者4.指南制定团队包括所有相关专业团体和个人5.涵盖了目标人群(患者、公众等)的意见和偏好6.明确定义指南的目标用户 DOMAIN 3.RIGOUR OF DEVELOPMENT DOMAIN 3.RIGOUR OF DEVELOPMENT 制定严谨制定严谨 7.用系统性方法寻找证据 8.清楚地描述选择证据的标准 9.清晰描述证据的优势和局限性 10.明确描述形成推荐意见的方法 11.制定指南时考虑到对健康的益处、

7、副作用和风险 12.指南推荐与证据支持之间有一个明确的相关性 13.指南在出版之前有外部专家的评审 14.提供指南更新的步骤 DOMAIN 4.CLARITY OF PRESENTATION DOMAIN 4.CLARITY OF PRESENTATION 清晰描述清晰描述 15.这些指南的建议和推荐是具体的、明确的 16.清晰呈现在处理不同条件下或健康问题的不同意见 17.指南的推荐意见清晰可见 DOMAIN 5.APPLICABILITY DOMAIN 5.APPLICABILITY 适用性适用性 18.指南具体描述了促进或阻碍应用的各种因素 19.指南提供了如何付诸实践的建议和/或工具

8、20.考虑到指南应用时潜在的资源利用 21.指南提出了监督和/或调整的标准 DOMAIN 6.EDITORIAL INDEPENDENCE DOMAIN 6.EDITORIAL INDEPENDENCE 制定的独立性制定的独立性 22.资助机构的意见对指南内容没有影响 23.记录并提及指南制定小组成员之间相互的利益冲突 OVERALL GUIDELINE ASSESSMENT OVERALL GUIDELINE ASSESSMENT 总的评价总的评价G Grading of rading of R Recommendations ecommendations A Assessment,sses

9、sment,D Development&evelopment&E Evaluation valuation between desirable and undesirable effects The larger the difference between the desirable and undesirable effects,the more likely a strong recommendation is warranted.The narrower the gradient,the more likely a weak recommendation is warranted Th

10、e higher the quality of evidence,the more likely a strong recommendation is warranted The more variability in values and preferences,or more uncertainty in values and preferences,the more likely a weak recommendation is warranted The higher the costs of an intervention,the less likely a strong recom

11、mendation is warranted 叙叙述述性性研研究究(Descriptive study)回回顾顾性性研研究究设设计计 病病例例-对对照照研研究究(Case-control study)科科研研设设计计方方案案 (Restrospective study)横横断断面面调调查查设设计计 (cross-sectional study)随随机机同同期期对对照照试试验验(RCT)队队列列研研究究(Cohort study)前前瞻瞻性性研研究究设设计计 (Perspective study)前前-后后对对照照研研究究(Before-after study)交交叉叉对对照照试试验验(Cros

12、s-over study)表表1.临临床床科科研研设设计计 方方案案的的分分类类：人群/癫痫类型、综合征/病因/严重程度/干预/排除因素：客观/准确/真实/可行 Terminal remission:a period of 2 or 5 years of seizure freedom off AEDs(Hauser&Kurland,1975).：足够长？无发作/复发/保留率：n1=n2=2(t+t2)s/2 power1,:0.05,0.10,0.2：20%,结果真实性?30%不能用：主观感觉作为观察指标时Type of Study Type of Study Meta-Analysis S

13、ystematic Review Randomized Controlled Trial Cohort studies Case Control studies Case Series/Case Reports Animal researchLevels of EvidenceH.Balshem et al./Journal of Clinical Epidemiology 64(2011)401e406G.H.Guyatt et al./Journal of Clinical Epidemiology 64(2011)1277e1282NOYES produced at national o

14、r international levels by medical associations or governmental bodies,such as the US Agency for Healthcare Research and Quality Local healthcare providers may produce their own set of guidelines or adapt them from existing top-level guidelines.medical guideline clearinghouses US：National Guideline C

15、learinghouse maintains a catalog of high-quality guidelines published by various organizations(mostly professional physician organizations)United Kingdom：National Institute for Health and Clinical Excellence(NICE).Netherlands：two bodies(CBO and NHG)publish specialist and primary care guidelines,resp

16、ectively Germany：the German Agency for Quality in Medicine(ZQ)coordinates a national program for disease management guidelines.All these organisations are now members of the Guidelines International Network(G-I-N),an international network of organisations and individuals involved in clinical practic

17、e guidelines.G-I-N is owner of the International Guideline Library the largest web based data base of medical guidelines worldwide-and pursue a set of activities aiming at promoting best practice and reducing duplication.British Columbia Medical Guidelines-In Canada,British Columbias guidelines and

18、protocols are developed under the direction of the Guidelines and Protocols Advisory Committee(GPAC),jointly sponsored by the B.C.Medical Association and the B.C.Ministry of Health Services.The Cochrane Collaboration-The Cochrane Collaboration is an international,independent,not-for-profit organisat

19、ion of over 27,000 contributors from more than 100 countries,dedicated to making up-to-date,accurate information about the effects of health care readily available worldwide.GuiaSalud.Clinical Practice Guidelines for the National Health System(Spain)-Contains clinical practice guidelines developed i

20、n Spain translated into English.Guideline Elements Model-The Guideline Elements Model(GEM)is an ASTM standard for the representation of practice guidelines in XML format.Guideline Interchange Format-The Guideline Interchange Format(GLIF)is a specification for structured representation of guidelines.

21、Guidelines International Network.Contains the largest online guideline library.Hospital Quality Alliance-A project of the Hospital Quality Initiative(HQI)of the Centers for Medicare and Medicaid Services.National Guideline Clearinghouse(NGC),a public resource for evidence-based clinical practice gui

22、delines.NGC is an initiative of the Agency for Healthcare Research and Quality(AHRQ),U.S.Department of Health and Human ServicesScottish Intercollegiate Guidelines Network(SIGN).Contains 113 evidence-based clinical guidelines published,in development,or under review.National Institute for Health and

23、 Clinical Excellence(NICE).AAN Practice GuidelinesThe American Academy of Neurology AGREE Collaboration This international collaboration of researchers and policy makers from a core of European countries as well as Canada,New Zealand,and the United States American Psychiatric Association Practice Gu

24、idelinesAccess practice guidelines and quick reference guides for various psychiatric and neuropsychiatric disorders,including delirium,Alzheimer disease,HIV,and substance abuse,developed by the American Psychiatric Association.The Brain Attack Coalition Stroke GuidelinesThe 15 guidelines provided o

25、n this site offer a comprehensive diagnostic tool to help both determine stroke severity and appropriate treatment.German Guidelines ClearinghouseThe German Guidelines Clearinghouse was commissioned by various German medical associationsGuidelines International Network(G-I-N)An international initiat

26、ive involving organizations from around the world,G-I-N seeks to improve the quality of healthcare by promoting systematic development of clinical practice guidelines and their application into practice.ICSI-Institute for Clinical Systems ImprovementThis independent,non-profit organization NGC-Natio

27、nal Guideline Clearinghousefor evidence-based clinical practice guidelines.NGC is sponsored by the Agency for Healthcare Research Quality in partnership with the American Medical Association and the American Association of Health Plans.NICE GuidelinesThe National Institute for Health and Clinical Ex

28、cellence(NICE)produces guidance related to Technology appraisals;Clinical practice;and Interventional procedures(for management of diseases within the National Health Service in England and Wales).AAN Systematic Review and Guideline Development ProcessAAN Systematic Review and Guideline Development

29、Process1840 1860 1880 1900 1920 1940 1960 1980 2000 Antiepileptic Antiepileptic DrugDrug201510 5BromidePhenobarbitalPhenytoinPrimidoneEthosuximideBenzodiazepinesCarbamazepineSodium ValproateVigabatrinZonisamideLamotrigineFalbamateGabapentinTopiramateFosphenytoin TiagabineOxcarbazepineLevetiracetamRe

30、nzo Guerrini,Lancet Lancet 2006;367:2006;367:499524499524Partial/MixedCAEPartial&1ary generalizedCAEJAEJMEGTCSCAEBECTSJMEMonotherapy2ary generalizedAdultsChildrenElderlyAdultsChildrenCBZA1st1stACCCCECECZP2ndDEEEEEEDDZPEEEEEEEEESM1stEEEEEEEEFBMEEEEEEEEGBPANoCEADEFDELEVNoNo2nd2nd2nd2ndEEEEEEEDLTGAB1st

31、1st1stc1stc1stc1stcCDACECEDLZPEEEEEEEEOXCANo1stCAECD-EEPBACCECCEEEPGBEEEEEEEEPHTAACDCCEEEPRMDEEEEEEETGBNoNoEEEEE-EETPMANo2nd2nd2nd1stcCCDCCEEDVGBCDEDE-EEVPAA1st1st1st1st1st1stBCDCCCCDZNSNoNoEEEEEEEDa Review of Guideline expected to start October 2008(Review Proposal-November 2007)b A=AED established

32、 efficaceous or effective as initial monotherapy;B=probably;C=possibly;D=potentially;E=No RCT data available;F=ineffective or significant risk of seizure aggravation;-=may precipitate or aggravate absence seizuresc Should be used as 1st choice under circumstances as outlined in NICE Technology Appra

33、isal of newer AEDs Partial onsetGTCSAANbSIGNNICEaILAEbFrench JA et al.Neurology 2004;62:12521260 AAN;SIGN,2005;NICE,2004;Glauser T et al.Epilepsia 2006;47:10941120 ILAEJ.Ruiz-Gimenez et al./Seizure 19(2010)375382Expert Rev.Clin.Pharmacol.1(5),661681(2008)R139GR43QK289MQ351XA322D GABRA1-:JME1/2/3/5:G

34、ABRG2:FS-evolving CAE,FS or FS plus,SMEI drug resistantstiripentolVPA,GABA+TPMExpert Rev.Clin.P 672 672 harmacol.1(5),harmacol.1(5),(2008)(2008)ABCB1 C3435T polymorphism and the risk of resistance to antiepileptic drugs in epilepsy:A systematic review and meta-analysisB.S.Haerian et al./Seizure 19(2

35、010)339346European journal of paediatric neurology 14(2010)116124复发的危险因素：symptomatic etiologyvarious seizure typesprior neonatal seizuresprior febrile seizuresBROWSE BY TOPICSBROWSE BY TOPICSAnaesthesia&pain control(217)Blood disorders(130)Cancer(438)Child health(1545)Child health Child health list

36、1545 review(s)list 1545 review(s)Mental Health(33)Neonatal care(300)Neurology(106)Neurology Neurology list 106 review(s)list 106 review(s)Cancer(3)Chronic Muscle Disease(1)Epilepsy:complementary&alternative therapy(5)Epilepsy:diet(1)Epilepsy:drugs for broad populations(27)Epilepsy:drugs for specific

37、 seizure types(1)Epilepsy:drugs for specific syndromes(2)Epilepsy:psychosocial interventions(3)Epilepsy:seizures associated with stroke(1)Epilepsy:service provision(1)Epilepsy:surgery(1)Epilepsy:treatment for acute symptomatic seizures(1)Epilepsy:treatment for status epilepticus(3)Epilepsy:withdrawi

38、ng antiepileptic drugs(2)Head injury(6)Headache&migraine(5)Motor neurone disorders(2)Movement disorders(6)Multiple sclerosis(4)Muscle disease(12)Neuromuscular junction disorders(7)Peripheral neuropathy(10)Sleep disorders(4)Spinal cord injury(3)Pediatric Neurology 46(2012)63-692000 Marson et al.Carba

39、mazepine vs valproate monotherapy for epilepsy Yes Pharmacologic 12652008 Michael and Marson Clobazam as add-on in the management of refractory epilepsy Yes Pharmacologic 1961999 Marson et al.Gabapentin as add-on for drug-resistant partial epilepsy YesPharmacologic 9972000 Ramaratnam et al.Lamotrigi

40、ne as add-on for drug-resistant partial epilepsy Yes Pharmacologic 15242000 Castillo et al.Oxcarbazepine as add-on for drug-resistant partial epilepsy Yes Pharmacologic 9612001 Taylor et al.Phenobarbitone vs phenytoin monotherapy for partial onsetYes Pharmacologic 599seizures and generalized onset t

41、onic-clonic seizures2008 Lozsadi et al.Pregabalin as add-on for drug-resistant partial epilepsy Yes Pharmacologic 13972002 Pereira et al.Tiagabine as add-on for drug-resistant partial epilepsy Yes Pharmacologic 9061999 Jette et al.Topiramate as add-on for drug-resistant partial epilepsy Yes Pharmaco

42、logic 13122008 Hemming et al.Vigabatrin for refractory partial epilepsy Yes Pharmacologic 7472000 Chadwick and Marson Zonisamide as add-on for drug-resistant partial epilepsy Yes Pharmacologic 8502007 Beavis et al.Pharmacologic interventions for epilepsy in patients withYes Pharmacologic 872intellec

43、tual disabilities2002 Privitera et al.Vagus nerve stimulation for partial seizures Yes Pharmacologic 5402005 Prasad et al.Anticonvulsant therapy for status epilepticus Yes Pharmacologic 20172002 Appleton et al.Drug management for acute tonic-clonic convulsions,Yes Pharmacologic 383including convulsi

44、ve status epilepticus in children2001 Sirven et al.Early vs late antiepileptic drug withdrawal for patients withYes Pharmacologic 924epilepsy in remission2004 Adab et al.Common antiepileptic drugs during pregnancy for women with Cond.AdvisedPharmacologic 4000epilepsy2006 Gamble et al.Lamotrigine vs

45、carbamazepine monotherapy for epilepsy Cond.AdvisedPharmacologic 13842003 Hancock and Cross Treatment of Lennox-Gastaut syndrome Cond.advised Pharmacologic 704 2010 Yalin et al.High-dose chemotherapy and autologous hematopoieticYes Pharmacologic 739stem-cell rescue for children with high-risk neurob

46、lastoma1999 Thompson et al.Helmets for preventing head and facial injuries in bicyclists YesPrevention 94622004 Liu et al.Helmets for preventing injury in motorcycle riders Yes Prevention 757512007 Soo and Tate Psychologic treatment for anxiety in people with traumaticYes Psychologic 44brain injury2

47、004 Brnfort et al.Noninvasive physical treatments for chronic/recurrent headache Yes Physically 26282004 Hoare et al.Botulinum toxin A as an adjunct to treatment in the managementYes Pharmacologic 397of the upper limbs in children with spastic cerebral palsy2007 Hoare et al.Constraint-induced moveme

48、nt therapy in the treatment of the Yes Pharmacologic 94upper limbs in children with hemiplegic cerebral palsy2005 Costa et al.Botulinum toxin type A therapy for cervical dystonia Yes Pharmacologic 6802009 Pringsheim al.Pimozide for tics in Tourette syndrome Yes Pharmacologic 1622004 Manzur et al.Glu

49、cocorticoid corticosteroids for Duchenne muscular dystrophy Yes Pharmacologic 3032007 Kley et al.Creatine for treating muscle disorders YesPharmacologic 3642000 Annane et al.Nocturnal mechanical ventilation for chronic hypoventilation inYes Ventilation 144patients with neuromuscular and chest wall d

50、isorders2002 Salinas et al.Corticosteroids for Bell palsy(idiopathic facial paralysis)Yes Pharmacologic 15692004 Mehndiratta et al.Plasma exchange for chronic inflammatory demyelinatingYes Plasmapheresis 44polyradiculoneuropathy2002 Raphal et al.Plasma exchange for Guillain-Barr syndrome YesPlasmaph