NICE-and-Orthopaedics课件.ppt

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1、NICE and OrthopaedicsBruce CampbellChair,NICE Interventional Procedures and Medical Technologies Advisory CommitteesBritish Orthopaedic AssociationDublin 16th September 2011The Plan.Origins of NICE and types of guidanceQuality Standards and PathwaysInterventional Procedures(and registers)Medical Tec

2、hnologiesNHS EvidenceNICE and the Health BillOrigins of NICE(1999-2002)TAs and Clinical Guidelines“Postcode prescribing”Variations in practice contrary to evidenceNHS equal access,good standards,valueInterventional ProceduresBristol cardiac+other high proNo scrutiny or governance for proceduresShort

3、comings of SERNIPNICE GuidanceTechnology Appraisals-Clinical and cost effectivenessClinical Guidelines-Managing specific conditions -Link to Quality Standards Interventional Procedures-Safety and efficacy Not costPublic HealthMedical Technologies device/diagnostic adoptionDiagnostics Technology Appr

4、aisals relating to OrthopaedicsMetal on metal hip resurfacingProstheses for THRAutologous chondrocyte implantationDrugs for rheumatoid,psoriatic arthritis,ankylosing spondylitis,osteoporosisClinical GuidelinesSpecific Guideline Development Groups127 Clinical Guidelines to date(August 2011)52 in deve

5、lopmentCore management of diseases/conditionsDescribe care pathwayRecommendations are advisoryLink with Quality Standards.NICE Quality Standardsfor treatment and prevention of specific conditionsSet of concise statements about careRelationship to NICE Clinical Guidelines Aspirational but achievableD

6、escribe good service Should be measurable to enable auditWill inform Commissioning(QOF,CQUIN)Topic list and development during 2011-2#NOF.+NQB engagement exercise NICE PathwaysThe new online way to access NICE guidance,linking:All kinds of guidanceQuality StandardsAudit and other toolsEasy and quick

7、No more hard copiesInterventional Procedures Guidance406 guidances since 2002(55 reviews)100th Committee meeting last week.and for orthopaedics.Upper limb+Foot+etcArtificial MCP and IP joint replacement 110Artificial trapeziometacarpal joint replacement 111Total wrist replacement 271Shoulder resurfa

8、cing arthroplasty 354Radiation therapy for Dupuytrens 368MTP joint replacement of the hallux 140Sinus tarsi implant for mobile flatfoot 305Minimal access surgery for hallux valgus 332Direct skeletal fixation of limb/digit prostheses using intraosseous transcutaneous implants 270Spinal procedures ope

9、n surgeryProsthetic lumbar disc replacement 100+306 Prosthetic cervical disc replacement 143+341Direct C1 lat mass screw cervical stabilisation 146 Interspinous distraction for spinal stenosis 165+365Non-rigid stabilisation for low back pain 183+366Lateral interbody fusion -lumbar spine 321Miscellan

10、eous“non-operative”CT guided thermocoagulation osteoid osteoma 53Autologous blood injection for tendinopathy 279ESWT for refractory plantar fasciitis 311ESWT for refractory Achilles tendinopathy 312ESWT for refractory tennis elbow 313ESWT for refractory Greater trochanteric pain 313Low intensity ult

11、rasound for fracture healing 374Interventional Procedures Advisory Committee(IPAC)Orthopaedics-Roger Atkins25 Members-Specialists;GP;Nurse;Lay;statistician;ABHI;MHRA;patient safetyMonthly meetings 4“scopes”check details 4“new”procedures 4 post-consultationPublic may attend(max 20)406 guidances since

12、 2002(55 reviews)Continual learning and evolutionEvidence used by the Interventional Procedures Advisory Committee(IPAC)Published studiesSpecialist Medical Advisers(questionnaires)Patient Commentators(questionnaires)Committee Members knowledgePublic consultation Published evidencePeer reviewed artic

13、lesAbstracts only for unique safety dataMain detailed table(usually 6-8 papers):RCTs,SRs,largest and most useful studiesAppendix:All other studiesSpecialist Advisers(clinicians)Nominated by professional organisationsUsually three or moreMay have done/not done procedureEstablished/Variation/NovelSafe

14、ty/Efficacy Views/ConcernsTraining and other issuesControversies.Case selectionPatient Commentators(since 2006)Questions include:How well procedure workedEffect on different specified areas of lifePain before/during/after procedureSide effectsConcerns about safety(before and after)Would you have aga

15、in if in same situation?Would you recommend to a friend?Examples of findingsQuality and Safety in Healthcare 2010;19:1-6 Campbell BMost“useful”:How well it worked;Effects on different areas of life;Would have again?Least useful:About pain;About information and consent(these questions now abandoned)M

16、ost frequent category:“Supports other evidence but no new insights”Only 0-3%(7%*):“New and original evidence”What to recommend when evidence for a procedure is inadequate?Possible recommendations:Do not use-very rareOnly in research-many problemsInterpreting IP recommendations“Special arrangements”O

17、pen to misinterpretationApplied to wide range of proceduresMore text in“Other comments”e.g.The Committee recognised the distress and disability caused by.If further evidence supports efficacy then potential to improve quality of life for many patientsOther recommendationsPatient selection-specialist

18、 teamsFacilities requiredTraining and expertiseOutcomes from further researchSubmission to registers.Registers for new proceduresour aspirationProcedures with inadequate evidenceSmall relevant datasetTo address explicit uncertaintiesTime-limited to answer questions(exceptions)Data on all patients tr

19、eated(link to funding)Timely analysis and review of dataCommon template decreasing difficulty and costWhy pursue the agenda for registers?Routinely collected NHS data inadequateNo codes for many new procedures/technologiesSafety and efficacy data negligibleControlled research trials problematicNeed

20、for data may not be adequate questionObstacles and delay in arranging“Only in research”may stop useHow helpful are data from registers?Would we not be better doing RCTs?Not a substitute for good researchProvide in“in use”/“real world”informationData need to be relevant and completeCan support or cha

21、llenge published dataSafety data uncommon adverse eventsValuable pilot data for planning researchBUTProblems with funding,design,submissionRegisters for new proceduresWe continue to:Recommend existing registers when suitableLiaise with national registers and specialist groups to adapt registersSeek

22、ways of creating simple new registers Improve coding of new proceduresPress the agenda for national data collectionPursue international agendaOrthopaedics and data collection The NJR.and moreIP evaluation of minimally invasive THR(2010)NJR data19,041 minimally invasive(from 344,953)Safety Outcomes(m

23、inimally invasive vs others)Calcar crack0.5%vs 0.4%Pelvic penetration 0.1%vs 0.2%Shaft fracture 0.1%vs 0.1%Shaft penetration 0.1%vs evaluation adoption Devices&diagnostics notified by manufacturers Selection by MTAC-advantages compared with“current management”:measurable improvements patient outcome

24、 or experienceuse of resources facilities,staff,testscostsustainabilityWe are looking for technologies which offer a“step change”Medical Technologies Advisory Committee(MTAC)Routing of“selected”productsTo other NICE ProgrammesTechnology Appraisals,Interventional Procedures,Diagnostics MTAC Med Tech

25、GuidanceAdvice on adoption(+clinical and cost data)and/or Research(+fostering research collaborations:use with data collection)MTAC Guidancelong term aimsBoost to novel and useful technologiesImprove research into devices and diagnosticsDemand for decent evidence in selection and for supportive guid

26、anceAdvise when evidence is inadequateFoster research on promising productsSelected products observational dataImpact of MTAC guidance.second item on BBC national news(after Libya)on 29 March 2011 Orthopaedics andnovel Med Tech productsNone notified yetThere must be lots in developmentScope very bro

27、adPlease consider with manufacturers NHS Evidence Latest evidence in health and social care Breadth of information Adjust to your needs Sources accreditedHealth and Social Care Bill:impact on NICERange and status of NICE guidance unaffectedNHS still to take account of NICE recommendationsKey partner

28、ship with NHS Commissioning BoardNICE Quality Standards for commissioning guidanceNew role in social careQuality Standards for social care on topics at the health and social care interface(eg dementia,medicines management)Move from SHA to Non-departmental Public BodyEnables move into social careUnderlines political independence