National Clinical Effectiveness Committee Standards for...

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.

3| National Clinical Effectiveness Committee | Standards for Clinical Practice Guidance

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.


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


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


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


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


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

http://www.health.gov.ie/patient-safety/ncec

http://www.health.gov.ie/patient-safety/ncec


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.


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.


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/

http://health.gov.ie/patient-safety/ncec/national-clinical-guidelines-2/

http://health.gov.ie/patient-safety/ncec/national-clinical-guidelines-2/


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


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.


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


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).


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


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.

http://health.gov.ie/patient-safety/ncec/clinical-practice-guidance/



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

http://www.agreecollaboration.org

http://www.ahrq.gov

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/resourcesintelligence/Quality_and_Patient_Safety_Documents/PPPG_Document_Development_and_Inventory/





http://www.healthnetworks.health.wa.gov.au/publications/docs/070626_WA_Health_Model_of_Care-overview_and_guidelines.pdf

http://www.healthnetworks.health.wa.gov.au/publications/docs/070626_WA_Health_Model_of_Care-overview_and_guidelines.pdf


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.




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/




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/

http://www.healthcareimprovementscotland.org/about_us/what_we_do/knowledge_management/knowledge_management_resources/methodology_toolkit.aspx

http://www.healthcareimprovementscotland.org/about_us/what_we_do/knowledge_management/knowledge_management_resources/methodology_toolkit.aspx

http://www.healthcareimprovementscotland.org/evidence.aspx

http://www.safetyandquality.gov.au/our-work/clinical-care-standards/

http://pathways.nice.org.uk/

https://www.nice.org.uk/guidance

https://www.nice.org.uk/standards-and-indicators

https://www.nice.org.uk/article/pmg20/chapter/1%20Introduction%20and%20overview

https://www.nice.org.uk/article/pmg20/chapter/1%20Introduction%20and%20overview

https://www.evidence.nhs.uk/

http://www.agreetrust.org/agree-ii/


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

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Department of Health, Hawkins House, Hawkins Street, Dublin, D02 VW90, IrelandTel: +353 1 6354000 • Fax: +353 1 6354001 • www.health.gov.ie

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