national clinical effectiveness committee …...development of all clinical guidance is underpinned...
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NATIONALCLINICALEFFECTI ENESSCOMMITTEE
National Clinical Effectiveness Committee Standards for Clinical Practice Guidance
November 2015
Table of Contents
Glossary of Terms 2
1. Purpose 4
2. Scope 5
3. Monitoring and Implementation 6
4. Expert advisory group 7
5. National Clinical Effectiveness Committee 8
6. Standards for Clinical Practice Guidance – rationale 11
7. Development of Clinical Practice Guidance 12
References 17
Appendix ASystematic literature review 19
Appendix BInternational resources 21
Appendix CBuilding a Culture of Patient Safety 22
Appendix DDefinitions/nomenclature 23
@NCECIreland
www.health.gov.ie/patient-safety/ncec
2 | Standards for Clinical Practice Guidance | National Clinical Effectiveness Committee
Clinical Practice Guidance
ClinicalPracticeGuidanceisdefinedassystematicallydevelopedstatementsor processes to assist clinician and patient decisions about appropriate health careforspecificclinicalcircumstances,withthetypeofclinicalpracticeguidancedeterminedbyevidence-basedcriteriaandclinicalrequirements.Suchclinicalguidanceincludesclinicalpolicies,procedures,protocolsandguidelines.
Clinical Guideline ClinicalGuidelinesaresystematicallydevelopedstatements,basedonathoroughevaluationoftheevidence,toassistpractitionerandpatientdecisionsaboutappropriatehealthcareforspecificclinicalcircumstances,across the entire clinical spectrum.
NCEC National Clinical Guideline
NCEC National Clinical Guidelines are a suite of guidelines that meet specificprioritisationandqualityassurancecriteriaandthathavebeenrecommended by the National Clinical Effectiveness Committee (NCEC).
Once a National Clinical Guideline is endorsed it supersedes any other guidelines on that topic.
Clinical Audit Clinical Audit is a cyclical process that aims to improve patient care and outcomesbysystematic,structuredreviewandevaluationofclinicalcareagainst explicit clinical standards.1
NCEC National Clinical Audit
NCEC National Clinical Audits are national audits which have been prioritised andqualityassuredbytheNationalClinicalEffectivenessCommittee(NCEC).
Clinical Policy A Clinical Policy is a written operational statement of intent which helps staff tomakeappropriatedecisionsandtakeactions,consistentwiththeaimsofthe service provider and in the best interests of service users.
Clinical Procedure A Procedure is a written set of instructions that describes the approved and recommendedstepsforaparticularactorsequenceofevents.
Clinical Protocol AClinicalProtocolisanagreedstatementaboutaspecificclinicalissue,withaprecisesequenceofactivitiestobeadheredto,withlittlescopeforvariation.ClinicalProtocolsareusuallybasedonguidelinesand/ororganisational consensus.
Clinical Decision Support
Clinical Decision Support refers to the provision of clinical knowledge and patientspecificinformationtohelpcliniciansandpatientsmakedecisionsthat enhance patient care.
Care Bundle A Care Bundle is a structured way of improving the processes of care and patientoutcomes:asmall,straightforwardsetofevidence-basedpractices—generallythreetofive—that,whenperformedcollectivelyandreliably,havebeen proven to improve patient outcomes.
Care Pathway A Care Pathway is a multidisciplinary care plan that outlines the main clinical interventions that are carried out by different healthcare practitioners for serviceuserswithaspecificconditionorsetofsymptoms.Theyareusuallylocallyagreed,evidence-basedplansthatcanincorporatelocalandnational guidelines into everyday practice.
Flowchart AFlowchartisadiagramofthesequenceofmovementsoractionsofpeopleor things involved in a complex system or activity.
Glossary of Terms
1 ThisdefinitionwillbealignedtotheforthcomingHealthInformationandPatientSafetyBill.
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Algorithm Algorithmsprovideevidence-basedstep-by-stepvisualinterpretationofthedecisionmakingand/orassociatedactionsrelatingtoaparticularguidancearea.Notablythestepswithinanalgorithmaremorenarrowlydefinedthanina guideline.
Checklist A Checklist is a tool that condenses a large volume of information and allows forsystematicverificationofstepsorpractices.
Model of care AModelofCareisamultifacetedconcept,whichbroadlydefinesthewayhealth services are delivered. A model of care outlines best practice patient care delivery through the application of a set of service principles across identifiedclinicalstreamsandpatientflowcontinuums.
The broad objective of developing a model of care is ensuring people get therightcare,attherighttime,bytherightteamandintherightplace.
Clinician A Clinician is a health professional involved in clinical practice.
Standard AStandardisadefinablemeasureagainstwhichexistingstructures,processesor outcomes can be compared.
Acronyms
CEU Clinical Effectiveness Unit.
CHO CommunityHealthOffice.
CMO ChiefMedicalOfficer.
CPG Clinical Practice Guidance.
DoH DepartmentofHealth.
DoHC DepartmentofHealthandChildren.
HIQA HealthInformationandQualityAuthority.
HR HumanResources.
HSE HealthServiceExecutive.
HTA HealthTechnologyAssessment.
IT Information Technology.
MHC MentalHealthCommission.
NCEC National Clinical Effectiveness Committee.
PPPG Policies,Procedures,ProtocolsandGuidelines.
SeeAppendixDforasummaryofdefinitions/nomenclaturecurrentlyinuse.
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Thepurposeofthisdocumentistoprovidestandardsforhealthcarestaffdevelopingevidence-based clinical practice guidance for health care.
What is Clinical Practice Guidance?
Clinical practice guidance is defined as systematically developed statements or processesto assist clinician and patient decisions about appropriate health care for specific clinicalcircumstances, with the type of clinical practice guidance determined by evidence-basedcriteriaandclinicalrequirements.Suchclinicalguidanceincludesclinicalpolicies,procedures,protocolsandguidelines.Carepathways,clinicaldecisionaids/tools,carebundles,flowcharts,checklistsandalgorithmscanformcomponentsofpolicies,procedures,protocolsorguidelines.
Does Clinical Practice Guidance improve patient care?
Clinicaleffectivenessisakeycomponentofpatientsafetyandquality.Theintegrationofbestevidenceinserviceprovision,throughclinicaleffectivenessprocessessuchasclinicalpracticeguidance,promoteshealthcarethatisuptodate,effectiveandconsistent.
The vision of the Standards for Clinical Practice Guidance is quality improvement for patientsafety.Theaddedvalueof standards forclinicalpracticeguidanceforpolicy,healthsystem,public and patients can include:
• Improving and optimising patient outcomes• Evidence-basedpractice• Standardisation of approach to avoid duplication• Facilitation of audit: provides parameters for audit• Reduction of variation in clinical practice• Consistency of nomenclature • Improvement of methodological rigour.
Why do we need Standards for Clinical Practice Guidance?
Inclinicalpractice,therearedifferenttypesofguidancethatvaryincomplexityandscope.Forexample,guidancecanbeacomprehensiveoverarchingNationalClinicalGuidelineoramorespecificclinicalprotocol.Regardlessofthevariationinscopeandfocus,itisimportantthatthedevelopment of all clinical guidance is underpinned by core standards using an evidence-based approach, to assist clinician and patient decisions about appropriate healthcare forspecificclinicalcircumstances.
Through consistency in approachand reduction in duplication, variation in practice can bereduced. Sharing of best practice will optimise use of health service resources and expertise.
NCEC approach to development of standards
ThestandardsweredevelopedbytheNCEC,informedbyasystematicliteraturereview,advicefrom an Expert Advisory Group and feedback from a public consultation process.
Aim: to publish standards for clinical practice guidance for healthcare providers.Objectives:
• Publish standards which will provide a standardised nomenclature and methodology for the developmentofevidence-basedclinicalpracticeguidancenationally.
• Ensure consistency of approach and minimise duplication in clinical practice guidance.
Purpose of this ‘Standards for Clinical Practice Guidance’ document1
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The Scope of the Standards for Clinical Practice Guidance includes Clinical Practice Guidance inhealthcare, spanning the fullmultidisciplinary team.This includesallhealthcareproviders inthe Republic of Ireland. The standards are applicable to healthcare in all settings e.g. acute care,socialcare,mentalhealth,careoftheelderly,primarycare,disabilities.
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Scope of the Standards for Clinical Practice Guidance
• Clinical policies
• Clinical procedures
• Clinical protocols
• Clinical guidelines
Thefollowingcanformcomponentsofpolicies/procedures/protocols/guidelines:• Carepathways,clinicaldecisionaids/tools,carebundles,flowcharts
(Organisation of care; to support systems of care)• Checklists,algorithms(Implementation)
The Standards for Clinical Practice Guidance include clinical policies, procedures, protocolsandguidelines.Carebundles,carepathwaysandclinicaldecisionaidscan formpartof theapproach to organisation of care for clinical guidance. Checklists and algorithms can form partof theguidance implementationtoolbox.Theseare includedascomponentsofpolicies,procedures, protocols and guidelines rather than stand-alone clinical practice guidance.Modelsofcare,asdescribedbytheHSEClinicalStrategyandProgrammesDivision(AppendixD),willalsobeinformedbythestandards.
There are existing regulatory frameworks which encompass requirements in relation to thedevelopment, implementation andmonitoring stages of clinical practice guidance, such asthe National Standards for Safer Better Healthcare (HIQA,2012)andtheQuality Framework for Mental Health Services(MHC,2007).TheStandards for Clinical Practice Guidance are intended to support and complement these existing processes.
ItisexpectedthattheHSEandallorganisationswilldevelopallnewandupdatedguidanceinlinewiththesestandards.Whereclinicalpracticeguidanceisalreadyinplace,aplantoreviewthis guidance should be made, with key patient safety areas prioritised. Review of existingguidanceisrecommendedevery3years,orsoonerifrequiredbylawornewevidence,auditorinformationindicatesrequiredchange.
Outside scopeThe Standards for Clinical Practice Guidance are applicable to healthcare processes which assist clinician and patient decisions about appropriate healthcare for specific clinicalcircumstances.Thesestandardsarenotintendedtocoveroperationalornon-clinicalprocessese.g.specimentransport,clinicalwastemanagement,HRpoliciesetc.
In exceptional circumstances, where interim clinical guidance is required on an emergencybasis (e.g.publichealthemergencies,hazardsandemerging infectious threatssuchasEbolavirus), thisguidanceshouldbedevelopedbyexperts,basedonthebestavailableevidence.If sustainedasguidance following the initialemergency, this interimguidancecanbe furtherdeveloped using the standards.
Scope2
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Organisations should put processes in place to implement and monitor these standards.
Formalgovernancearrangementsforclinicalpracticeguidanceatlocal,regionalandnationallevel should be established and documented by healthcare providers. This governance processshouldclearlyoutlinequalityassurancemechanisms,specificrolesandresponsibilities,accountability and authority. Clear processes for developing, approving, disseminating,implementing, monitoring, auditing and updating clinical practice guidance within the organisation needs to be clearly outlined and available for staff.
The Health Service Executive has established a National PPPG Steering Group for policies,procedures,protocolsandguidelines(PPPG)todevelopaframeworkthatwillclearlydefinetheprocess for the use and implementation of the NCEC Standards for Clinical Practice Guidance. Agovernanceprocess,standardtemplate,stafftrainingandnationalrepositoryforHSECPGsisalsoplannedbytheHSE.
The Standards for Clinical Practice Guidance provide a framework for assessment and audit. It is expected that the health system regulators will assess the corporate assurance arrangements in place to ensure effective implementation of these standards.
Monitoring and Implementation3
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An expert advisory group was established to provide advice and information to the NCEC in the development of the standards. The members of this group are listed below.
Organisation / Division (nominated by) Nominee
ClinicalEffectivenessUnit,DepartmentofHealth
Dr Niamh O’Rourke (Chair)
HSEQualityImprovementDivision(Dr Philip Crowley)
Ms Brid Boyce
HSEMentalHealthDivision(Ms Anne O’Connor)
Ms Margaret Brennan
HSEQualityAssuranceVerification(QAV)Division(Mr Patrick Lynch)
Dr Edwina Dunne
IndependentHospitalAssociationofIreland(Ms Catherine Whelan)
Dr Stephen Frohlich
HSESocialCareDivision(MrPatHealy)
Dr Siobhan Kennelly
HSEClinicalStrategyandProgrammesDivision(Dr Áine Carroll)
Ms Aveen Murray
HSEAcuteHospitalsDivision(Mr Liam Woods)
Ms Deirdre O’Keeffe
HSEPrimaryCareDivision(MrJohnHennessy)
MsVirginiaPye
Expert advisory group4
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The National Clinical Effectiveness Committee (NCEC) is a Ministerial committee established by theDepartment of Health as part of the Patient Safety First Initiative toprovideoversight forthenationalclinicaleffectivenessagendawhichincludesNationalClinicalGuidelines,NationalClinical Audit and Clinical Practice Guidance.
Membership of the committee is multidisciplinary and includes representatives from: the Health Information and Quality Authority, Mental Health Commission, Health and SocialCare Regulatory Forum, Health Products Regulatory Authority, State Claims Agency, Forumof Postgraduate Training Bodies, Nursing and Midwifery Education Bodies, Forum of HospitalGroupCEOs,HSEClinicalProgrammes,HSEQualityImprovementDivision,HSEOfficeofNursingand Midwifery Services, National Office for Clinical Audit, Independent Hospital Associationof Ireland,DepartmentofHealth, Health InsuranceCouncil, Health Research Boardand twopatient representatives.
The NCEC Terms of Reference are to:1. Provide strategic leadership for the national clinical effectiveness agenda.2. Contributetonationalpatientsafetyandqualityimprovementagendas.3. Publish Standards for Clinical Practice Guidance. 4. Publish guidance for National Clinical Guidelines and National Clinical Audit.5. Prioritiseandquality-assureNationalClinicalGuidelinesandNationalClinicalAudit.6. Commission National Clinical Guidelines and National Clinical Audit. 7. Align National Clinical Guidelines and National Clinical Audit with implementation levers.8. Report periodically on the implementation and impact of National Clinical Guidelines
and the performance of National Clinical Audit. 9. Establishsub-committeesforNCECwork-streams.10. PublishanAnnualReport.
The NCEC framework is outlined in Figure 1 below. Further information on the NCEC framework andNCECdocumentation includingendorsementandqualityassurancecriteria forNationalClinical Guidelines and National Clinical Audit is available at: www.health.gov.ie/patient-safety/ncec
Figure 1: NCEC framework
National Clinical Effectiveness Committee5
National Clinical Effectiveness Committee (NCEC)Patient Safety First Initiative
Ministerial committee (Supported by the Clinical Effectiveness Unit)
Suite National Clinical
Guidelines
StandardsClinical Practice
Guidance
SuiteNational
Clinical Audit
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Clinical Effectiveness Processes
Clinicaleffectivenessisakeycomponentofpatientsafetyandquality.Theintegrationofbestevidence in service provision, through clinical effectiveness processes, promotes healthcarethatisuptodate,effectiveandconsistent.Clinicaleffectivenessprocessesincludeguidelines,audit and clinical practice guidance.
This work emanates from a request by the Minister for Health that NCEC would developstandards for clinical practice guidance following the Report of the CMO into Portlaoise PerinatalDeaths(2014)asoutlinedintheboxbelow.ThedevelopmentofStandards for Clinical Practice Guidance builds on existing frameworks such as Safer Better Healthcare(HIQA2012),Building a Culture of Patient Safety(DoHC2008)andtheQuality Framework for Mental Health Services(MHC2007).
Clinical Effectiveness
Recommendation Responsible body
R.19 The National Clinical Effectiveness Committee should develop standards for clinical practice guidance.
NCEC Standarddefinitionsandcriteriashouldbedeveloped in relation to the various forms of clinicalpracticeguidancesuchasguidelines,checklists,procedures,clinicalguidance,clinical protocols etc. This will ensure consistency of approach and utilisation of appropriate methodology to develop clinical practice guidance nationally.
National context
The Health Information and Quality Authority developedNational Standards for Safer Better Healthcarein2012todescribewhatahighquality,safeservicelookslike.Thesestandardsareanimportant driver for the implementation of clinical guidance as they set out the need for clinical decisions to be based on best available evidence and information; “to drive improvements in thequalityand safetyofhealthcare it is important thatdecisions, includingclinicaldecisions,are based on the best available evidence and information”.
The report of theCommissionon Patient SafetyandQualityAssurance,Building a Culture of Patient Safety(DoHC2008)andtheQuality Framework for Mental Health Services(MHC2007)alsorecommendthedevelopmentofevidence-basedstandards.
It is important that the NCEC Standards for Clinical Practice Guidance are aligned with other national standards, initiatives and levers for implementation. The HSE work on PPPGs willcomplement and support the implementation of the NCEC Standards for Clinical Practice Guidance through a shared vision for evidence-based practice that reduces variation andduplication in clinical practice.
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Theexisting regulatory andpolicy frameworks encompass thedevelopment, implementationand monitoring stages of clinical practice guidance and are summarised in the box below:
National Standards for Safer Better Healthcare (HIQA, 2012)
Standard2.1.Healthcarereflectsnationalandinternationalevidenceofwhatisknowntoachievebestoutcomes for service users.
2.1.1 Healthcarethatisdeliveredaccordingtopolicies,guidelines,protocolsandcarepathwaysthat are based on best available evidence.
2.1.2UseofNationalClinicalGuidelinesandnationallyagreedprotocols,carebundlesandcarepathways where available.
2.1.6Anevidence-basedprocessforthedevelopmentofpolicies,guidelines,protocolsandcarepathways.
2.1.7Supportforandfacilitationof,theworkforceinmakingdecisionsbasedonthebestavailableevidence.
2.1.8 Support for healthcare professionals in making clinical decisions based on evidence which will maximisebenefitstoserviceusersandminimiseunnecessarytreatmentandcare.
Standard2.6.Careisprovidedthroughamodelofservicedesignedtodeliverhighquality,safeandreliable healthcare.
2.6.2Deliveryofcareusinghighquality,safeandreliablemodelsofservicedeliverythathavetherequiredclinicalservices,meetlegislativerequirementsandtakeintoaccountbestavailableevidence,nationalpolicies,NationalClinicalGuidelinesifavailable,localpopulationhealthneeds and available resources.
Standard 7.2. Serviceprovidershavearrangementsinplacetoachievebestpossiblequalityandsafetyoutcomes for service users for the money and resources used.
Building a Culture of Patient Safety (DoHC, 2008) (See appendix C for full text of recommendation)
5.5: Organisationalperformanceindicatorsandtargetsintheareaofsafetyandquality.5.16: Mandatory standards and key performance indicators. 5.19:Strongemphasisonsafetyandqualityinthetrainingandeducationofhealthcare
professionals.6.6: Licencing should be linked to compliance with stated standards. 6.9: HIQAshouldprogressurgentlythedevelopmentofstandardsonsafetyandquality.6.11: The regulations that determine the criteria for obtaining a licence should include
implementationofevidence-basedpractice.7.1: Productionofevidence-basedinformationandguidanceforuseinpolicymaking,system
reform and individual patient and professional interactions. 7.2: Evidence based service frameworks covering the major health conditions. 7.4: Evidencebasednationalstandardsshouldbedeveloped,withmultidisciplinaryinput,inboth
primaryandsecondarycaresettings,andforthetransitionbetweencaresettings.
Quality Framework for Mental Health Services (MHC, 2007)
Standard8.1Thementalhealthserviceisdeliveredinaccordancewithevidence-basedcodesofpractice,policiesandprotocols.
8.1.3 The mental health service has uniform policies across service areas.
Standard 8.3 Corporate governance underpins the management and delivery of the mental health service.
8.3.2 The mental health service facilitates service user involvement at all stages of policy and servicedevelopment,deliveryandevaluation.
8.3.7 The mental health service implements a clinical governance system for improving clinical practice.
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Differenttypesofclinicalguidancewillvaryincomplexityandscope,withthechoiceofclinicalpractice guidancemodel determined by evidence-based criteria and clinical requirements.Not all guidance requires the same pathway of development as an NCECNational ClinicalGuideline. Further information is available at http://health.gov.ie/patient-safety/ncec/national-clinical-guidelines-2/
However,regardlessofthevariationinscopeandfocus,itisimportantthatthedevelopmentofall clinicalguidance is underpinnedbyanevidence-basedapproachandqualityassurancemeasures to assist clinician and patient decisions about appropriate healthcare for specificclinical circumstances.
In terms of clinical practice guidance, the health system as a whole is engaged with thedevelopmentofprocesses to supportclinicaldecisionmakingat local, regionalandnationallevel as part of the quality improvement process. These processes involve the developmentofpolicies,protocols,protocolsandguidelines. Themethodology todevelop theseprocessesis variable and the provision of NCEC Standards for Clinical Practice Guidance will promote consistency of approach and utilisation of appropriate methodology to develop evidence-based clinical practice guidance nationally.
TheNCECsoughttoestablishtheextentandqualityoftheevidenceinternationallyonclinicalpractice guidance in terms of effectiveness, rigour of development and quality assuranceprocesses. A systematic literature review to support a framework for the development of standards for clinical practice guidance was completed in March 2015.2 In summary, thepublished evidence on effectiveness of clinical practice guidance is limited. The evidence review however provides a useful backdrop for the development by NCEC of Standards for Clinical Practice Guidance.
The key messages from the literature included: • There isa lackof standardisationof terminology,methodologyandqualityassuranceof
clinicalpracticeguidancedevelopment,implementationandevaluationinternationally.• There is a lack of evidence relating to cost effectiveness and clinical effectiveness of clinical
practice guidance internationally. • Clinicalpracticeguidancemustbeevidence-based.• Multi-stakeholder involvement is a key requirement for the effective development of
guidance. • Theliteraturerevealedbarriersandfacilitatorsatthepatient,healthcareprofessional,team,
organisational and health system level.• Improvements to clinical guidance can be secured if barriers are tracked and a systems
approachistakentothedevelopment,implementationandevaluationofguidance.
The research team made recommendations pertaining to the development, management,implementation and evaluation of clinical guidance, including IT systems. A summary of theliterature search strategy and results are outlined in Appendix A.
Standards for Clinical Practice Guidance – rationale6
2 CompletedbyaresearchteambasedinUCC.Literaturereviewisavailableat:http://health.gov.ie/patient-safety/ncec/
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These standards aim to promote consistency of clinical practice guidance across the country and avoid duplication. Synergies should be maximised across departments/organisations tooptimise value for money and use of staff time and expertise. It is not in the interests of patient safety for individualorganisations/units todevelopor implementdifferentguidance for similarclinical circumstances. Where feasible and appropriate organisations should promote and utilisenationalclinicalpracticeguidancedevelopedinlinewiththesestandards,toavoidanyunnecessaryduplication,encompassinganylocalimplementationrequirementsasrequired.
Prior tocommencingthedevelopmentofclinicalpracticeguidance, thefollowingshouldbeestablished:
Existing CPGs Isevidence-basedclinicalpracticeguidancealreadyavailableforthistopic/clinicalquestion?(local,nationalorinternational).
IstheexistingCPGup-to-date,peerreviewedwithrigorousmethodology,generalisabletotargetpopulationandapplicabletoIreland?
Adapt/adopt Is this CPG being developed de novo orbeingadapted/adoptedfromexistingguidancenationally/internationally?
Coverage/geography
IsthisCPGbeingdevelopedasnational,regional(e.g.hospitalgroup/communityhealthoffice)orlocalguidance?
Will the proposed CPG be relevant for use in a wider geographical area or wider clinicalarea?Ifso,widercollaborationneedstobeconsidered. Ingeneral,clinicalpracticeguidanceshouldnotvarybylocation,althoughthemechanism for local implementation may differ.
Multidisciplinary Does the CPG group membership include all relevant stakeholders and professionalgroupings,toensureintegratedcarefortheserviceuser?
Governance Hasagovernancemodelbeenestablishedforthedevelopment,approval,dissemination,implementation,monitoring,audit,updatingandrepositoryofClinicalPracticeGuidanceinyourorganisation?
Model Whattypeofguidanceisrequiredforthistopic/clinicalquestion?(E.g.policy,procedure,protocol,guideline),basedontheclinicalrequirements.
Evidence base Haveyouestablishedaccesstoalibraryorclinicallibrarian?Haveyouestablishedlinkswithanacademicpartner/thirdlevelinstitution?
The description of core components in this document provides a useful checklist for monitoring and audit.
Development of Clinical Practice Guidance7
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Core components
Anumberofcorecomponentsformthebasisforhighqualityevidence-basedclinicalpracticeguidance, which can be grouped into the four categories of governance, methodology,planning and implementation and communications.
Each of these components is described below, with a checklist of criteria to assist in thedevelopment of clinical practice guidance. All clinical practice guidance should meet these standards,whilesomewillbedevelopedtoahigherstandardas required(denotedcomplexCPGs below).
Core components – Standards for evidence-based Clinical Practice Guidance
Governance Governance model
Audit,monitoring,review&evaluationprocess
Service user and stakeholder involvement
Knowledge management
Methodology Clarity of scope and purpose
Evidence-based
Planning & Implementation
Resource implications
Planning&Implementation
Communications Communications
ThesestandardswillbereviewedandupdatedbytheNCECasrequired.
Thecurrentversionisavailableonwww.health.gov.ie/patient-safety/ncec
Level of complexity
Clinicalpracticeguidancemayrequiredifferentlevelsofcomplexity,proportionatetothetypeofguidance.Forexample,aNationalClinicalGuidelinewillrequireafullbudgetimpactanalysisand possibly a Health Technology Assessment (HTA), whereas a protocol may only requireconsiderationoftheresourcesrequiredtodevelopandimplementtheprotocol.Itisexpectedthat all clinical practice guidancewill meet all minimum standards, whereasmore complexguidancemay requireadditional rigour. Thestandardsbelowdifferentiatebetweenminimumstandardsandmorerigorousrequirementsforcomplexguidance.
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Figure 2: Core Components – Standards for Clinical Practice Guidance
Governance model
Serviceuser/stakeholder involvement
Knowledge management
Resource implications
Evidence based
Clarity of scope and
purpose
Standards forClinical Practice
Guidance
Communications
Planning&Implementation
Audit,monitoring,review and evaluation
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Standards for Clinical Practice Guidance
1. Clarity of scope and purpose
Thedecisionmakingapproachrelatingtotypeofguidancerequired(policy,procedure,protocol,guideline),coverageoftheguidance(national,regional,local)andapplicablesettings are described.
r
Theoverallobjective(s)oftheclinicalguidancearespecificallydescribed. r
Theclinicalquestion(s)coveredbytheguidancearespecificallydescribed. r
Thetargetusersandthepopulation/patientgrouptowhomtheguidanceismeanttoapplyarespecificallydescribed. r
Thepotentialforimprovedhealthisdescribed(e.g.clinicaleffectiveness,patientsafety,qualityimprovement,healthoutcomes,qualityoflife,qualityofcare). r
ThescopeoftheCPGisclearlydescribed,specifyingwhatisincludedandwhatliesoutsidethe scope of the CPG. r
2. Governance model
Formalgovernancearrangementsforclinicalpracticeguidanceatlocal,regionalandnational level are established and documented. r
Conflictofintereststatementsfromallmembersoftheguidancedevelopmentgrouparedocumented,withadescriptionofmitigatingactionsifrelevant. r
The guidance has been reviewed by independent experts prior to publication. (asrequired,complexCPGs).
3. Communications
A communication plan is developed to ensure effective communication and collaboration with all stakeholders throughout all stages. r
Plan and procedure for dissemination of the CPG is described. r
4. Service user and stakeholder involvement
Stakeholderidentificationandinvolvement:Theguidancedevelopmentgroupincludesindividualsfromallrelevantstakeholders,staffandprofessionalgroups. r
Guidanceisinformedbytheidentifiedneedsandprioritiesofserviceusersandstakeholders. r
The views and preferences of the target population have been sought and taken into consideration(asrequired).
Thereisserviceuser/layrepresentationonguidancedevelopmentteam(asrequired).
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5. Evidence-based Systematic methods used to search for evidence are documented (for CPGs which are adapted/adoptedfrominternationalguidance,theirmethodologyisappraisedanddocumented).
r
Criticalappraisal/analysisofevidenceusingvalidatedtoolsisdocumented(thestrengths,limitationsandmethodologicalqualityofthebodyofevidenceareclearlydescribed). r
Thehealthbenefits,sideeffectsandriskshavebeenconsideredanddocumentedinformulating the guidance. r
There is an explicit link between the clinical guidance and the supporting evidence. rTheguidance/recommendationsarespecificandunambiguous. rAsystematicliteraturereviewandHealthTechnologyAssessment(HTA)hasbeenundertaken(asrequired,complexCPGs).
6. Knowledge management (Accessibility/sharing of best practice)
The clinical guidance is easily accessible by all users e.g. CPG repository. r
Documented process for version control is provided. r
Copyright and permissions are sought and documented. r
7. Resource implicationsThe potential resource implications of developing and implementing the guidance are identifiede.g.equipment,education&training,stafftimeandresearch. r
Synergiesaremaximisedacrossdepartments/organisationstoavoidduplicationandtooptimise value for money and use of staff time and expertise. r
Budgetimpactanalysisisdocumented(asrequired,complexCPGs).
Literaturereviewofcosteffectivenessisdocumented(asrequired,complexCPGs).
8. Planning and Implementation Writtenimplementationplanisprovidedwithtimelines,identificationofresponsiblepersons/units and integration into service planning process. r
Barriersandfacilitatorsforimplementationareidentified,andalignedwithimplementationlevers. r
Informationandsupportisavailableforstaffonthedevelopmentofevidence-basedclinicalpractice guidance. r
There is collaboration across all stakeholders in the planning and implementation phases to optimisepatientflowandintegratedpatientcare. r
Education and training is provided for staff on the development and implementation of evidence-basedclinicalpracticeguidance(asrequired,complexCPGs).
9. Audit, monitoring, review & evaluation process
Process for monitoring and continuous improvement is documented. r
Processforevaluationofimplementationandclinicaleffectivenessisspecified. r
Auditcriteriaandauditprocess/planarespecified. r
Documentedprocessforrevisions/updatingandreview,includingtimeframeisprovided. r
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References
DepartmentofHealth(2014)HSE Midland Regional Hospital, Portlaoise Perinatal Deaths (2006-date). Report to theMinister for Health, Dr James Reilly TD from Dr Tony Holohan, the ChiefMedicalOfficer.Dublin,DoH.
DepartmentofHealthandChildren (2008)Building a Culture of Patient Safety. Report of the CommissiononPatientSafetyandQualityAssurance.Dublin,StationaryOffice.
Health InformationandQualityAuthority(2011)National Quality Assurance Criteria for Clinical Guidelines. Dublin,HIQA.
HealthInformationandQualityAuthority(2012)National Standards for Safer Better Healthcare. Dublin,HIQA.
HealthInformationandQualityAuthority(2013)Guiding Principles for National Health and Social Care Data Collections.Dublin,HIQA.
Hegarty,J.,SavageE.,Cornally,N.,ByrneS.,HennP,FlynnM,McLoughlinK,FitzgeraldS,(2015).A systematic literature review to support a framework for the development of standards for clinical practice guidance. Department of Health; Dublin. Available at: http://health.gov.ie/patient-safety/ncec/clinical-practice-guidance/
MentalHealthCommission(2007) Quality Framework. Mental Health Services in Ireland. Dublin,MHC.
NationalClinicalEffectivenessCommittee(2013)Guideline Developers Manual.Dublin,DoH.
National Clinical Effectiveness Committee (2015) Preliminary Prioritisation Process National Clinical Guidelines.Dublin,DoH.
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Sources for core components: AustralianCommissiononSafetyandQualityinHealthCare(2015)Guide to the National Safety and Quality Health Service standards for health service organisational boards.Sydney,NSQHS.
HealthInformationandQualityAuthority(2012)National Standards for Safer Better Healthcare. Dublin,HIQA.
National Clinical Effectiveness Committee & Health Information and Quality Authority (2015) National Quality Assurance Criteria for Clinical Guidelines. Version 2. To provide quality assuarance of National Clinical Guidelines in Ireland.Dublin,NCEC/HIQA.
TheAGREENextStepsConsortium(2009)Appraisal of Guidelines for Research & Evaluation II. AGREE II instrument. The Agree Research Trust www.agreecollaboration.org
Sources of definitions/nomenclature:AgencyforHealthcareResearchandQuality(2010)Challenges and Barriers to Clinical Decision Support (CDS) Design and Implementation www.ahrq.gov
Health Information and Quality Authority (2014) Report of the review of the governance arrangements as reflected in the safety, quality and standards of services at UL Hospitals.Dublin,HIQA.
HealthInformationandQualityAuthority(2008)National Hygiene Services Quality Review 2008: Standards and Criteria.Dublin,HIQA.
Health Service Executive (2012) HSE procedure for developing Policies, Procedures, Protocols and Guidelines. HSE http://www.hse.ie/eng/about/Who/qualityandpatientsafety/resourcesintelligence/Quality_and_Patient_Safety_Documents/PPPG_Document_Development_and_Inventory/
Hegarty,J.,SavageE.,Cornally,N.,ByrneS.,HennP,FlynnM,McLoughlinK,FitzgeraldS,(2015).A systematic literature review to support a framework for the development of standards for clinical practice guidance. Department of Health; Dublin. Available at: http://health.gov.ie/patient-safety/ncec/clinical-practice-guidance/
LangleyG,MoenR,NolanK,Nolan T,NormanC,Provost L (1987) The improvement guide. A practical approach to enhancing organizational performance. 2nd edition. San Francisco,Jossey-Bass.
National Clinical Effectiveness Committee & Health Information and Quality Authority (2015) National Quality Assurance Criteria for Clinical Guidelines. Version 2. To provide quality assuarance of National Clinical Guidelines in Ireland.Dublin,NCEC/HIQA.
WAHealthNetworks(2007)Model of Care: overview and guidelines. Ensuring people get the right care, at the right time, by the right team and in the right place.WesternAustralia,DepartmentofHealth.http://www.healthnetworks.health.wa.gov.au/publications/docs/070626_WA_Health_Model_of_Care-overview_and_guidelines.pdf
19| National Clinical Effectiveness Committee | Standards for Clinical Practice Guidance
Appendix A: Systematic literature review
Key databases and grey literature sources were searched for evidence which evaluated guidance(guidance,pathway,policy,protocol,bundle,standard,algorithm,checklist,decisionaid, model of care), development, implementation and evaluation processes. A total of 49papers were included in this systematic review (Table 1). Owing to the lack of level one evidence (i.e.RCTs,meta-analysis,systematicreviewsofRCTs)andheterogeneityofmethodologiesandoutcomes, definitive conclusions could not be made as to the effectiveness of the variousguidancetypesreviewed.However,theanalysisofpaperswithinthesystematicreviewsurmisedthat the implementation of guidance had a positive effect on patient outcomes and on the processes of care.
Table 1: Systematicreview-Categoryofpapersforeachtypeofguidance
Alg
orit
hms
Bund
les
Che
ckl
ists
Path
wa
ys
Polic
y
Pro
toc
ols
Sta
nda
rds
of C
are
TOTA
L
1 SRofSRs,MAs&primarystudies 1 1
2 Meta –analysis (MAs) 2 2 4
3 SRs&MA 1 1 2 4
4 SRs of SRs 1 1
5 SR of primary studies 6 1 3 8 8 7 1 34
6 SR&expertopinion 1 1
7 Papers on developing guidance inc. SRs 1 1 1 1 4
Total 9 4 4 13* 9 8 2 49
SR=systematicreview;MA=meta-analysis*Note: 15 papers reviewed on pathways but three papers related to the same body of evidence (Rotter etal.,2009;2010;2012)
Source: Hegarty, J., Savage E., Cornally, N., Byrne S., Henn P, Flynn M, McLoughlin K, Fitzgerald S, (2015). A systematic literature review to support a framework for the development of standards for clinical practice guidance. Department of Health; Dublin. Available at: http://health.gov.ie/patient-safety/ncec/clinical-practice-guidance/
Atanationallevel,evidence-basedguidancecanbeprovidedthrough:statementswhichassistclinicaldecisionmaking(clinicalguidelines);statementsof intent(policy),andthearticulationof national standards against which practice can be benchmarked. The implementation of guidance in clinical practice can be supported through the use of implementation tools: protocols,algorithmsandchecklists. In termsofnationalapproaches to theorganisationandprovisionofevidence-basedcare,thesecanincludeclinicalcarepathwaysandcarebundles.
Specific review questionswere included in the research objectives for the systematic reviewincluding; definitions of clinical practice guidance, core elements, decision criteria, qualitycriteria, impact, resources, updating processes, expertise required, format, strengths andweaknesses,barriersandfacilitators.Table2summarisesthepapersreviewedforeachoftheseareas.
20 | Standards for Clinical Practice Guidance | National Clinical Effectiveness Committee
Table 2:Numberofpapersprovidingdataoneachquestionaddressedinthesystematicliteraturereview
Alg
orit
hms
(n=9
)
Bund
les
(n=4
)
Che
ckl
ists
(n=4
)
Path
wa
ys(n
=15)
*
Polic
y(n
=9)
Pro
toc
ols
(n=7
)
Sta
nda
rds
of c
are
(n=2
)
TOTA
L
Q 1 Definitions 2 3 2 10 2 5 0 24
Q 2 Core elements 2 2 0 11 4 1 2 22
Q 3 Decision criteria 7 0 4 2 3 5 2 23
Q 4 Methodological processes** 8 1 1 6 6 6*** 1 29
Q 5 Qualitycriteria****(for 4 above)
7 0 0 3 1 2 0 13
&/orassessmentofqualityofstudies in review paper
1 2 1 10 3 4 0 21
Q 6 (i) Impact i.e. outcomes 4 4 2 12 1 5 1 29
(ii) Method of impact validation
0 0 0 0 0 1 0 1
(iii) Implementation audit incl. outcome of implementation
1 1 0 0 0 4 0 6
Q 7 Resourceimplications(time/cost)
3 0 3 5 1 3 1 16
Q 8 Updating processes 1 0 0 1 1 1 0 4
Q 9 Expertise needed 5 0 3 8 6 3 1 26
Q 10 Layout/format 4 0 3 4 4 5 0 20
Q 11 (i) Strengths 4 0 4 11 1 0 1 21
(ii) Weaknesses 6 0 3 3 0 1 0 13
Q 12 Barriers 3 2 3 6 4 1 2 21
Q 13 Facilitators 5 0 3 7 7 6 3 31
*Pathways:Threeofthesepapersrelatetoonebodyofevidence(Rotter2009,2010,2011),presentedasone paper in table.**Methodologicalprocesses:Mostpapersaddresseddevelopmentprocesses,someofwhichalsoreportedonimplementation&evaluation.***Protocols: One paper on protocols reported only on implementation process.****Qualitycriteria:Thisincludesuseofagradingsystemtoassessthequalityofevidencerelevanttothedevelopment of guidance type.
Source: Hegarty, J., Savage E., Cornally, N., Byrne S., Henn P, Flynn M, McLoughlin K, Fitzgerald S, (2015). A systematic literature review to support a framework for the development of standards for clinical practice guidance. Department of Health; Dublin. Available at: http://health.gov.ie/patient-safety/ncec/clinical-practice-guidance/
21| National Clinical Effectiveness Committee | Standards for Clinical Practice Guidance
Appendix B: Examples of International resources
Health Improvement Scotland: Methodology toolkit http://www.healthcareimprovementscotland.org/about_us/what_we_do/knowledge_management/knowledge_management_resources/methodology_toolkit.aspx
Health Improvement Scotland: Evidence for healthcare improvement: evidence, advice, guidance and standards http://www.healthcareimprovementscotland.org/evidence.aspx
Australian Commission on Safety and Quality in Health Care: Clinical care standards http://www.safetyandquality.gov.au/our-work/clinical-care-standards/
National Institute for Health and Care Excellence (NICE), UK; • NICE pathways: http://pathways.nice.org.uk/ • NICE guidance https://www.nice.org.uk/guidance• NICE standards and indicators https://www.nice.org.uk/standards-and-indicators• NICEguidelines: themanual(2014)https://www.nice.org.uk/article/pmg20/chapter/1%20
Introduction%20and%20overview• NICE Evidence Services https://www.evidence.nhs.uk/
AGREE - international tool to assess the quality and reporting of practice guidelineshttp://www.agreetrust.org/agree-ii/
22 | Standards for Clinical Practice Guidance | National Clinical Effectiveness Committee
Appendix C: Building a Culture of Patient Safety
The report of theCommissionon Patient SafetyandQualityAssurance,Building a Culture of Patient Safety (DoHC2008)recommendsthedevelopmentofevidence-basedstandards:
Leadership and accountability
R5.1 Key leadership roles must be assigned to designated professionals and agencies at national level for the purpose of providing strong clinical leadership to the system in the area of patient safetyandquality.Suchleadershiprolesmustincludeadvocacyforsafetyandquality,thedevelopment and dissemination of patient safety knowledge and learning and the promotion of good practice.
R5.5 Organisational codes of governance must be implemented which clearly identify safety and qualityasacoreobjectiveandwhichspecifytheprocessesbywhichtheseobjectiveswillbeachieved.Organisationalperformanceintheseareasshouldbemonitored,through,forexample,thesettingofspecificorganisationalperformanceindicatorsandtargetsintheareaofsafetyandqualityandtherequirementforregularreportsviainternalandexternalaccountability mechanisms on delivery against those targets. Patients should be provided with an accessible opportunity to contribute to such accountability mechanisms.
R5.16 TheBoardmustreview,onaregularbasis,thesystemsofgovernance,includingriskmanagementandaudit,relatingtohealthcaresafety,qualityandperformance.Thisshouldinclude: mandatory standards and key performance indicators.
R5.19 Thereshouldbeastrongemphasisonsafetyandqualityinthetrainingandeducationofhealthcare professionals. All bodies responsible for the training and continuing development of healthcareprofessionalsshouldreviewtheircurriculatoensurethatpatientsafetyandquality,includingtechnicalandhumanfactors,isincorporatedintothemodules.
Organisational and Professional Regulatory Framework
R6.6 Licencingshouldbelinkedtocompliancewithstatedstandards,enforceablethroughinspectionandimpositionofsanctionsifnecessary.Thesanctionsshouldrangefromwarnings,withtimelimitsforcompliance,uptowithdrawaloflicenceeitherforaspecificservicewithinthehospitalorthehospitalitselfifrequired.
R6.9 Inadvanceoftheintroductionoflegislationprovidingforlicensing,HIQAshouldprogressurgentlythedevelopmentofstandardsonsafetyandqualitytobeappliedtohospitalsandallfuturelicensedhealthcarefacilities.HIQAshouldalsobeaskedtocommenceworkimmediatelyonstandardsinrespectofanyareawhereahighandintermediaterisktothehealthand/orwelfareofpatientsorthepublicisidentified.Subjecttocurrentlegalprovisions,arrangementsshould be put in place by which private healthcare providers would voluntarily adhere to such standards,agreetobemonitoredandtheresultingreportspublished.PrivatehealthinsurersshouldrequireallprivatehealthcarefacilitiestoadheretothestandardssetbyHIQAwheresuchstandards exist.
R6.11 The regulations that determine the criteria for obtaining a licence should include; implementationofevidence-basedpractice.
Quality Improvement and Learning Systems
R7.1 Aleadershiproleinrelationtotheanalysisofinternationalevidenceandresearch,andtotheproductionofevidence-basedinformationandguidanceforuseinpolicymaking,systemreform and individual patient and professional interactions should be developed.
R7.2 ArollingprogrammeshouldbedevelopedbytheDepartmentofHealth,HIQAandtheHSEtodeliverevidence-basedserviceframeworkscoveringthemajorhealthconditionswithinthepublichealthcaresystem,similartotheNationalServiceFrameworksmodelintheUK.Suchframeworks should be reviewed periodically to encompass new evidence on effectiveness and performance.
R7.4 Evidence-basednationalstandardsshouldbedeveloped,withmultidisciplinaryinput,inbothprimaryandsecondarycaresettings,andforthetransitionbetweencaresettings.
23| National Clinical Effectiveness Committee | Standards for Clinical Practice GuidanceA
pp
end
ix D
: De
finiti
ons
/no
me
ncla
ture
– e
xam
ple
s c
urre
ntly
in u
se
NC
EC/
HIQ
A 2
015
UC
C s
yste
ma
tic re
vie
w 2
015
(pp
58-
61)
HSE
PPP
G 2
012
Clin
ica
l Po
licy
Clin
ica
l po
licy:
A w
ritte
n o
pe
ratio
na
l st
ate
me
nt
of i
nte
nt
wh
ich
he
lps
sta
ff t
o
ma
ke a
pp
rop
riate
de
cisi
on
s a
nd
ta
ke
actions,consistentwiththeaimsofthe
serv
ice
pro
vid
er a
nd
in t
he
be
st in
tere
sts
of s
erv
ice
use
rs.
Polic
y:NationalHealthSystems
leve
l po
licy
ca
n b
e c
on
side
red
conceptuallyasanoverarching,
hig
he
r le
vel s
et
of s
tate
me
nts
wh
ich
canre
latetogovernance,financial
an
d d
eliv
ery
arr
an
ge
me
nts
with
in
wh
ich
clin
ica
l (a
nd
pu
blic
he
alth
) p
rog
ram
me
s a
nd
se
rvic
es
are
p
rovi
de
d (
Lavi
s e
t a
l.,2010).
Polic
y: A
po
licy
is a
writ
ten
st
ate
me
nt
tha
t c
lea
rly in
dic
ate
s th
e p
osit
ion
an
d v
alu
es
of t
he
o
rga
nisa
tion
on
a g
ive
n s
ub
jec
t (HIQA,2008).
Clin
ica
l Pro
ce
dur
ePr
oc
ed
ure
: A p
roc
ed
ure
is a
w
ritte
n s
et
of i
nst
ruc
tion
s th
at
de
scrib
e t
he
ap
pro
ved
an
d
rec
om
me
nd
ed
ste
ps
for a
particulara
ctorsequenceof
events(HIQA,2008).
Clin
ica
l Pro
toc
ol
Clin
ica
l pro
toc
ol:
An
ag
ree
d s
tate
me
nt
aboutaspecificclinicalissue,w
ith
aprecise
sequenceofa
ctivities
tobeadheredto,w
ithlittlescope
for v
aria
tion
. Clin
ica
l pro
toc
ols
are
usuallybasedonguidelinesand/or
org
an
isatio
na
l co
nse
nsu
s.
Pro
toc
ol:Specificandprecise
step
by
ste
p a
pp
roa
ch
oft
en
use
d t
o
sup
po
rt t
he
imp
lem
en
tatio
n o
f c
linic
al g
uid
elin
es
wh
ich
are
aim
ed
at
red
uc
ing
va
riatio
ns
in c
linic
al p
rac
tice
a
nd
ou
tco
me
s (Il
ott
et
al.,2010;Ebben
et
al.,2013).
Pro
toc
ol: Aprotocolisdefined
asawrittenplanthatspecifies
pro
ce
du
res
to b
e fo
llow
ed
in
definedsituations;aprotocol
rep
rese
nts
a s
tan
da
rd o
f ca
re
tha
t d
esc
ribe
s a
n in
terv
en
tion
o
r se
t o
f in
terv
en
tion
s. P
roto
co
ls arem
oreexplicitandspecificin
theirdetailthanguidelines,they
specifywhodoeswhat,when
andhow(AnBordAltranais2000).
Pro
toc
ols
are
mo
st t
ypic
ally
use
d
wh
en
de
velo
pin
g in
stru
ctio
ns
for
drugprescription,d
ispensingand
administration,i.e.d
rugprotocols.
24 | Standards for Clinical Practice Guidance | National Clinical Effectiveness CommitteeN
CEC
/ H
IQA
201
5U
CC
sys
tem
atic
revi
ew
201
5(p
p 5
8-61
)H
SE P
PPG
201
2
Clin
ica
l Gui
de
line
Clin
ica
l gui
de
line
: Sys
tem
atic
ally
developedstatements,b
asedona
thorougheva
luationoftheevidence,to
ass
ist p
rac
titio
ne
r an
d p
atie
nt
de
cisi
on
s a
bo
ut
ap
pro
pria
te h
ea
lthc
are
for
specificclinicalcircumstances,across
the
en
tire
clin
ica
l sp
ec
tru
m.
Gui
de
line
:Aguidelineisdefined
as
a p
rinc
iple
or c
rite
rion
th
at
gu
ide
s o
r dire
cts
ac
tion
(C
on
cise
O
xfo
rd D
ictio
na
ry 1
995)
. Gu
ide
line
developmentemphasizesusing
cle
ar e
vid
en
ce
fro
m t
he
exi
stin
g
literature,ratherthanexpert
opinionalone,a
sthebasisfo
radvisorm
aterials(W
HO2009).
Na
tiona
l Clin
ica
l Gui
de
line
NC
EC N
atio
nal C
linic
al G
uid
elin
es:
A
suiteofg
uidelinesthatmeetspecific
qualityassuranceandprioritisa
tion
crit
eria
an
d t
ha
t h
ave
be
en
re
co
mm
en
de
d b
y th
e N
atio
na
l Clin
ica
l Ef
fec
tive
ne
ss C
om
mitt
ee
.
Che
ckl
ist
Che
ckl
ist:
Too
ls th
at
co
nd
en
se a
larg
e
volu
me
of i
nfo
rma
tion
an
d a
llow
for
systematicverificationofstepsor
practices(Hewsonetal.,2006;Hales
et
al.,2008;W
HO2008).
25| National Clinical Effectiveness Committee | Standards for Clinical Practice GuidanceN
CEC
/ H
IQA
201
5U
CC
sys
tem
atic
revi
ew
201
5(p
p 5
8-61
)H
SE P
PPG
201
2
Path
wa
y In
teg
rate
d c
are
pa
thw
ay
(clin
ica
l ca
re
pa
thw
ay)
: a m
ulti
disc
iplin
ary
ca
re
pla
n t
ha
t o
utli
ne
s th
e m
ain
clin
ica
l in
terv
en
tion
s th
at
are
ca
rrie
d o
ut
by
diff
ere
nt
he
alth
ca
re p
rac
titio
ne
rs fo
r patientswithaspecificconditionorset
of s
ymp
tom
s. T
he
y a
re u
sua
lly lo
ca
lly
agreed,evidenced-basedplansthat
ca
n in
co
rpo
rate
loc
al a
nd
na
tion
al
gu
ide
line
s in
to e
very
da
y p
rac
tice
.
Path
wa
y:EPA
definition:“Acomplex
inte
rve
ntio
n fo
r th
e m
utu
al d
ec
isio
n
ma
kin
g a
nd
org
an
isatio
n o
f ca
re
processesfora
well-definedgroupof
patientsduringawell-definedperiod”
(Ba
rbie
ri e
t a
l.,2009).
A c
linic
al p
ath
wa
y:
• I
nc
lud
es
a s
tru
ctu
red
mu
ltid
iscip
lina
ry
pla
n o
f ca
re (
ma
nd
ato
ry)
• I
s u
sed
to
tra
nsla
te g
uid
elin
es
or
evi
de
nc
e in
to lo
ca
l str
uc
ture
s•
De
tails
th
e s
tep
s in
a c
ou
rse
of
treatm
entorc
areinaplan,
pathway,algorithm,g
uideline,
pro
toc
ol o
r oth
er '
inve
nto
ry o
f a
ctio
ns'
•Hastim
eframesorc
riteria-based
pro
gre
ssio
n
• I
s a
ime
d t
o s
tan
da
rdise
ca
re fo
r a
specificclinicalproblem,p
rocedure
or e
piso
de
of h
ea
lthc
are
in a
specificpopulation.
An
inte
rve
ntio
n is
ca
lled
a c
linic
al
pathwayifitmeetsthefirstcriteria
plu
s th
ree
ou
t o
f th
e o
the
r fo
ur c
rite
ria
(Kin
sma
n e
t a
l.,2012).
Ca
re b
und
leA
ca
re b
und
le is
a s
tru
ctu
red
wa
y o
f im
pro
vin
g t
he
pro
ce
sse
s o
f ca
re
andpatientoutcomes:asmall,
straightforwardsetofe
vidence-based
practices—generallythreetofive—
that,whenperform
edcollectivelyand
reliably,havebeenproventoim
prove
patientoutcomes.(HIQA,2014)
Bund
le: A
se
lec
ted
se
t o
f in
terv
en
tion
s o
r pro
ce
sse
s o
f ca
re d
istill
ed
fro
m
evi
de
nc
e b
ase
d p
rac
tice
co
mp
on
en
ts
that,whenim
plementedasagroup,
pre
sen
ts a
mo
re ro
bu
st p
ictu
re o
f th
e
qualitycareprovided,b
enchmarks
pe
rfo
rma
nc
e a
nd
imp
rove
s p
atie
nt
outcomes.(Be
rwick,2006)
26 | Standards for Clinical Practice Guidance | National Clinical Effectiveness CommitteeN
CEC
/ H
IQA
201
5U
CC
sys
tem
atic
revi
ew
201
5(p
p 5
8-61
)H
SE P
PPG
201
2
Alg
orit
hmA
lgo
rithm
: Alg
orit
hm
s p
rovi
de
evidencebasedstep-by-stepvisual
inte
rpre
tatio
n o
f th
e d
ec
isio
n m
aki
ng
and/ora
ssociatedactionsrelatingto
a p
art
icu
lar g
uid
an
ce
are
a. N
ota
bly
th
e s
tep
s w
ithin
an
alg
orit
hm
are
mo
re
narrowlydefinedthaninaguideline
(Beitzetal.,2012).
Sta
nda
rdSt
and
ard:A
definablem
easureagainst
whichexistingstructures,processesor
ou
tco
me
s c
an
be
co
mp
are
d.
Sta
nda
rd: A
“st
an
da
rd”
he
lps
to c
rea
te
a c
om
mo
n u
nd
ers
tan
din
g o
f th
e
sta
nd
ard
of c
are
se
rvic
e u
sers
ca
n
exp
ec
t to
rec
eiv
e. A
na
tion
al s
tan
da
rd
pro
vid
es
a s
tra
teg
ic a
pp
roa
ch
an
d
a c
lea
r be
nc
hm
ark
with
th
e a
im o
f improvingsafety,q
ualityandre
liability
withinthehealthservices(HIQA,2012).
27| National Clinical Effectiveness Committee | Standards for Clinical Practice GuidanceFl
ow
cha
rtAdiagramofthesequenceofm
ovementsora
ctionsof
pe
op
le o
r th
ing
s in
volv
ed
in a
co
mp
lex
syst
em
or a
ctiv
ity.
(Oxf
ord
dic
tion
ary
)
Aflowchartorflowdiagramisagraphicre
presentationof
aseriesofa
ctivitiesthatdefineaprocess.
(Theim
provementguide,Langley1987)
Clin
ica
l de
cis
ion
aid
/to
ol
Clin
ica
l de
cisi
on
su
pp
ort
refe
rs t
o t
he
pro
visio
n o
f clin
ica
l knowledgeandpatientspecificinform
ationtohelp
clin
icia
ns
an
d p
atie
nts
ma
ke d
ec
isio
ns
tha
t e
nh
an
ce
p
atie
nt
ca
re.
OsheroffJA,PiferEA,TeichJM2005
(AHRQ,2010)
Mo
de
l of c
are
A‘modelofc
are’isam
ultifacetedconcept,which
broadlydefinesthewayhealthservicesaredelivered
(Queensla
ndHealth2000).A
modelofc
areoutlinesbest
pra
ctic
e p
atie
nt
ca
re d
eliv
ery
th
rou
gh
th
e a
pp
lica
tion
of
asetofserviceprinciplesacrossidentifiedclinicalstreams
andpatientflowcontinuums.(WaikatoHealthBoard
2004).
[HSEClinicalStrategyandProgrammesDivision]
Modelofc
areoverviewandguidelines(2007)
DepartmentofH
ealth,W
Australia
The
bro
ad
ob
jec
tive
of d
eve
lop
ing
a m
od
el o
f ca
re is
ensuringpeoplegettherightcare,a
ttherighttim
e,b
yth
e ri
gh
t te
am
an
d in
th
e ri
gh
t p
lac
e.
Modelofc
areoverviewandguidelines(2007)
DepartmentofH
ealth,W
Australia
28 | Standards for Clinical Practice Guidance | National Clinical Effectiveness Committee
29| National Clinical Effectiveness Committee | Standards for Clinical Practice Guidance
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