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NeurologySectionProceduresforEvidence-BasedDocumentDevelopment

I. DefinitionsofEvidenceBasedDocumentsClinicalPracticeGuideline(CPG)Clinicalpracticeguidelinesaregradedrecommendationsonbestpracticeforaspecificconditionbasedonthesystematicreviewandevaluationofthequalityofthescientificliterature.Thesedocumentsaredefinedbyastringentmethodologyandformalprocessfordevelopment.Clinicalpracticeguidelinesarerequiredtobridgethegapbetweenevidenceandrecommendationandaremadeupofbothevidence-basedandexpert-basedinformationtoguideclinicalpracticedecision-making.Althoughvariationcanexist,allmustmeetstandardcriteria.

ClinicalPracticeAppraisals(CPA)/ClinicalGuidanceStatements(CGS)ClinicalpracticeappraisalsorguidancestatementssummarizebestpracticeforanareaofclinicalpracticebasedupontheintegrationofavailableliteraturefromCPGsandexpertopinion.Thesedocumentsaredefinedbyastrongmethodologyincludingananalysisoftheavailableresearchandstructuredprocessfordevelopment.Variationmayexistbutallmustmeetstandardcriteria.

SystematicReview(SR)Asystematicreviewisabalancedsynthesisofevidencerelatedtoadefinedclinicalquestion.Thesystematicreviewappliesanexplicit,reproduciblemethodologyandsystematicsearchoftheliterature.Systematicreviewssearch,appraise,summarize,andidentifygapsinknowledge.UndernocircumstancedoesanSRprovidearecommendationforpractice.Clinicalpracticeguidelinesarerequiredtobridgethegapbetweenevidenceandrecommendation.

ClinicalsummaryClinicalpracticesummariesarereferencedbasedandpeerreviewedsummariesoftheevidence.Thesedocumentsdescribewhatisknownsofarandfocusonclinicalapplicationfollowingastandardformatwhichincludesoverview,classification,screening,examination,diagnosis,prognosis,intervention,medicalmanagement,andcaseexamples.ThesearepublishedonPTNow.

ProceduralsummaryAproceduralsummaryisavariationofaclinicalsummaryfornon-clinicalpopulationcontentsuchassafepatienthandling,electricalstimulation,etc.APTAhasnotformalizedadefinitionforproceduralsummarybeyondthis.TheTaskforceinterpretsthisEBDasastep-by-stepdescription.

Positionstatement/WhitepaperPositionstatementsareintendedtosetforthapositionbasedonclinicalcontentrelatedtothephysicaltherapistsscopeofpractice.Thesedocumentsarereferencedandpeerreviewed.Theyareintendedforaconsumeraudience.

PocketguidePocketguidesareshortsummarystatementsinaportabletool.Apocketguidecouldbederivedfromanyoftheabovedocuments.Whenpocketguidesaredevelopedindependentofanotherdocument,theyareintendedtobebasedonbestavailableevidenceandexpertconsensusandarereferencedandpeerreviewed.

ConsumerdocumentsTheAPTAispresentlytalkingaboutthistypeofdocumentasacompaniontoCPGsorCGSs.

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II. StructureandPeopleNeededtoDevelopEvidenceBasedDocuments(EBDs)

TheNeurologySectioncompletesthedevelopmentofEBDswiththefollowingstructure:

1. TheDirectorofPracticealongwiththe3-5memberAdvisoryCommitteewilloverseetheprocess.TheFigurebelowillustratestherelationshipoftheDirectorofPracticeandAdvisoryCommitteetotheEBDworkgroups.TheSectionleadershipalongwiththeDirectorofPracticeandAdvisoryCommitteewilldeterminehowmanyworkgroupswillbeinprocessatanyonetime.

Director of Practice/EBP Coordinator

and Advisory Committee

VesUbularHypofuncUonCPGChair

OutcomeMeasuresCPGChair

Workgroup#3Chair(e.g.,LocomoUonin

Stroke)

Workgroup#4Chair

Workgroup#5Chair

Workgroup#6Chair

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2.ThefigurebelowillustratesthecompositionofeachEBDWorkGroup.Thoseroleswithsolidlinesarerequiredmembersofthegroupandthoseconnectedwithdashed-linesserveconsultativeroles.ThescopeoftheprojectandEBDtype(CPG,CGS,SR)willdeterminehowmanyclinicalcontentandresearchcontentmemberswillbeneeded.EBDWorkGroups(topic-specificandmultiplegroupscanbeworkingsimultaneously)

*scopeofprojectandEBDtype(CPG,CGS,SR)determineshowmanymembersofaworkgroupwillbeneeded

III. RolesandResponsibilitiesNeurologySectionBoardofDirectors

DeterminesthenumberofSection-sponsoredclinicalpracticeguidelines(CPGs)andotherevidence-baseddocuments(EBDs)tobedevelopedatanyonetimebasedontheavailablefinancialsupportfortheprocessandavailableexpertise.

• SectionsupportforthedevelopmentofanEBDshouldbedependentupontheavailabilityandapplicabilityofexistingEBDsonaparticulartopicandavailabilityofqualifiedandwillingEBDdevelopmentleaderandworkinggroup.

• NeedforaEBD(topicidentification)shouldbeabi-directionalprocessfromthebottomup(memberfeedback)andtopdown(deliberationattheAdvisoryCommitteelevel).

• Selectsmembersofadvisorycommittee.

DirectorofPractice/Evidence-basedDocument(EBP)Coordinator

• Possessesbackground(orhasaccesstotraining)inevidencebasedpracticeandEBDdevelopmentmethodology;demonstratedskillinscientificwritingandcriticalappraisalprocess;knowledgeinthecontinuumofcareandneurologicalphysicaltherapy.

TopicFocusedEBDChair(methods,administrator)

MedicalLibrarianEBDMethodologists(2)(e.g.,includeAdvisoryCommi`eeMember)

StakeholderReviewCommi`ee

(e.g.,MD,RN,SW,OT,SLP,Policy/payors,Consumer/Family)

ResearchContentExperts(2-3)*

ClinicalContentExperts(NCS)(2-3)*

StaUsUcian

ProjectManager/Admin

Support

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• OverseesandmanagesWorkingGroups(WorkingGroupsareheadedbyatopic-focusedEBPChair)andAdvisoryCommitteeactivities.

• ProvidesexpertiseandresourcesonmethodologytoWorkingGroupChairandmembers.• AlongwiththeAdvisoryCommittee,developsaplanfortheupdateofallpublishedEBDsasneeded

(butatleastreviewedevery5years).• AlongwithAdvisorycommittee,maintainsandmanagesallmattersofconflictofinterest.

AdvisoryCommittee

• Consistsof3-5members.DirectorofPractice/EBPCoordinatorandexpertsinknowledgetranslationandEBDdocumentdevelopmentmethodologyandscientificwriting/editing.

• WiththeassistanceofBoardofDirectorsandNeurologySectionMembership,identifies,prioritizes,andrefinestopicstobedeveloped.

• Assistsinperiodically(aswarrantedbychangesinneurologicalphysicaltherapypracticeand/orpoliciesandasstandardsforthedevelopmentofEBDsevolve)conductingneedsassessmentfortopicsidentification.

• OrganizesandplacescalltoSectionmembers,NCS,and/orSIGmembersforvolunteers.WorkswithSIGtoidentifycontentexpertsaspotentialmembersofEBDworkgroups.ScreensCV/resumestodeterminequalificationsasclinicalorresearchexpert.

• RecommendstotheDirectorofPracticeandtheSectionBoDtheappointmentofworkgroupleaders,andworkinggroupmembers.PlacesacalltoSectionmembers,NCS,and/orSIGmembersasappropriate;andscreenCV/resumetodeterminequalificationasclinicalorresearchexperts.

• Assistsworkgroupswithidentifyinganddelineatingthecontentareasoftheirevidencebaseddocuments.

• Assistsworkgroupswithsecuringadditionalexternalreviewers.• AssistsWorkingGrouponscopeofEBDs.• Reviews,editsandapprovesallEBDs(bothoriginalandsubsequentrevisions)submittedbythe

WorkingGroupsattherequestoftheDirectorofPractice/EBPCoordinator.Withrespecttoediting:EditstheCPGsubmissionfromtheworkgroupsothatguidelineshaveaconsistentlabelingsystemthatfollowsbothICFandICDtaxonomiesandareformattedforpublicationineitherJNPTorPTJ.

• WithdirectorofPractice,maintainsandmanagesallmattersofconflictofinterest.• MaintainsalistofpotentialReviewerswithexpertiseinvariouscontentareas.• SubmitsanypublishedCPGtoNationalGuidelinesClearinghouse.

TopicFocusedEBDChairandWorkGroup:

ChairisappointedbyAdvisoryCommittee.

• Mustdeclareconflictofinterestbeforeapprovalofappointment.• Primaryroleismanagerofgroupprocess,aswellas“tiebreaker”duringreviewofabstracts,

researchpapersorotherevidencebaseddocuments.Guidedevelopmentprocess;Facilitatecommunication;Managetasks;Delegateanddirectteamontasks;Conductfirsteditorialreview

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priortoExternalReviewGroup;Alongwithworkinggroupmembers,identifymembersofexternalreviewgroupanddevelopstimeline.

• Skillsneededincludeefficient,motivated,organized,demonstratedleadershipability,scientificwriting,fluentinuseofInternet,e-mail,andstorageservices(eg,Skydrive,GoogleDocs).PriorexperiencewithEBDsorCPGdevelopmentwouldbebeneficial.

• Familiarwithliteratureandmanagementoftheclinicalconditionorprocedure.• Decides,alongwithworkgroup,onthenatureoftheEBD(eg,CPG,CGS,SR,ClinicalSummary).• CommunicateregularlywithAdvisoryCommittee

WorkGroup(seechart:Recommendapproximately6full-timemembers)

• PotentialmemberscanbeidentifiedbytheChair,AdvisoryCommittee,and/orSectionleadership.• Considerationsasaclinicalexpertincludesexperienceinasetting,yearsofpractice,degreeand

certification,CIexperience,publicationofcasereportsandsimilardocumentsonthetopics,presentationandteachingexperience.Recommend2membershaveclinicalexpertiseintheworkgroup.

• Considerationsasaresearchexpertincludesexperienceinresearchdesignandmethodology,facilityincriticalappraisal,scientificwritinginthecontentarea.Recommend2membershaveresearchexpertiseintheworkgroup.

• Asearchspecialist(medicallibrarian)andstatisticianmayberequiredanditisrecommendedthattheseareadhocandcontractualpositions(budgetedthroughtheAPTAEBDproposalprocessorfundedthroughNeurologySection).

• UnderstandingofEBPandEBDdevelopmentiscriticalforsuccess.• ResponsibilitiesoftheWorkGroupinclude:discloseconflictofinterest,participateinallconference

calls,attendallmeetingswithacommitmenttoteamworkandclearcommunication,readingallrelevantmaterialanddoingallnecessarybackgroundworktofullyparticipate,respondingtoe-mailcommunicationsinatimelyfashion,completingallpersonalassignmentstomeetdeadlines,maintainingconfidentiality.

ThenextpageincludestheConflictofInterestformthateachEBDworkgroupmembershouldcompleteandsubmittotheAdvisoryCommitteefortheirreviewandapproval.

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CONFLICT OF INTEREST DISCLOSURE FORM

Name: ______________________________________ (Every panelist must complete a separate form)

Guideline name and chapter (if known): __________________________________________________

____________________________________________________________Date: ___________________ The Neurology Section (NS) of the American Physical Therapy Association, and the Evidence-based Documents (EBD) Advisory Committee (AC) of the Practice Committee (PC) strive to produce high-quality, unbiased EBDs. As such the policy requires full disclosure by all guideline authors, editors, and reviewers of all potential conflicts of interest (COI) related to NS activities, real or perceived, including those that are unrelated to the guideline topic. The AC and Director of Practice reviews the disclosures and either recommends approval, approval with management, or disapproval to the NS Board of Directors. It is the AC responsibility to issue the final vote on each candidate. Examples of COIs that clearly disqualify a nominee include employment by a pharmaceutical or device manufacturer, particularly if the drugs or devices manufactured are related to a specific EBD topic. Nominees who serve as consultants or participate on advisory boards should provide as much information as possible in order for the AC and Director of Practice to evaluate the potential COI accordingly. It is not the goal of the AC to preclude all individuals with COIs. Rather, the goal is to ensure full transparency while protecting the integrity of the EBDs, the EBD panelists, and the NS. It is not the role of the AC to serve as a policing body for its EBD panels. However, if the committee or its members discover through other means that non-disclosed COIs exist, then the nomination in question can be revoked.

Annual updates must be submitted to the AC until the date of the final proof of the manuscript. COI forms are stored and archived with the NS Board. DEFINITION: For purposes of the NS and this disclosure form, a COI or competing interest is a financial relationship or other set of circumstances that might affect, or might reasonably be thought by others to affect, an author's judgment, conduct or other work. A COI exists based on the contributor’s circumstances. The contributor’s behavior, subjective beliefs, and outcomes are irrelevant. In other words, the contributor must disclose a COI, even if the circumstances do not actually influence the contributor’s actions or manuscript, and even if the contributor believes that the circumstances cannot or will not affect the contributor’s actions. In parentheses below are some, but not all, examples.

Within the last 3 years and presently (for you and your parents, siblings, spouses, life companion or children):

COI Topic NO Yes (if yes, explain and where applicable provide $ amount Do you have, or are named in, any grants (clinical, educational, research) on EBD topic from any funding body (non-profit, private, corporate)?

Receive royalties or in-kind benefits (travel; accommodations; per diem; meals) from a commercial or professional entity?

Own shares (stock option holder) of a device/equipment or company with ties to EBD topic?

Act as an employee, officer, or director of a device/ equipment or pharmaceutical company? Specify interaction with FDA, financial analysts

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Serve as a consultant to a device or pharmaceutical company or perform advocacy work related to the EBD topic?

Act as an employee, officer or director of an institution or employer that has a financial relationship with a commercial entity having an interest related to the EBD topic of interest?

Provide money for patient enrollment or other aspect of research related to the EBD topic?

Hold patent rights or pending patent application on EBD topic of interest?

Participate in speaking activities, advisory committee, or other activities related to industry sources, with or without receiving honoraria or in kind benefits (sponsored by a nonprofit university, annual meeting, inservice, symposia; sponsored by a for- profit health company)? Include any participation in CE or related speaking on this EBD topic. If you sit on advisory committees on this EBD topic, include it here.

Make/Made public statements on this EBD?

Provide legal assistance (or expert testimony) on litigation related to EBD topic?

Clinical practice related COI: Do you perform clinical procedures in your clinical practice related to EBD topic of interest? Estimate the percentage of time you treat patients related to EBD topic

Anything else that could be perceived by others to affect your objectivity? Include any published papers (research, educational, perspective, reviews, etc)

ATTESTATION: I attest that my answers are true, that I have disclosed all conflicts of interest in accordance with the conflicts of interest policy and that the disclosed conflicts of interest (if any) will not bias, or in any way impact the integrity of, my work. If I choose to submit this form electronically, I agree that keying in my name and corresponding date at the top of this form indicates my assent to its terms and is equivalent to my signature. SIGNATURE:

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IV. TOPICIDENTIFICATION• Board,AdvisoryCommittee,and/ormembershipcanproposeatopicforthedevelopmentofan

EBD.

• BoardandAdvisoryCommitteeprioritizetopicstobetransitionedintoanEBD.

• Topicshouldbebasedonclinicianinterest,consumerdemand,prevalenceofthediagnosisinphysicaltherapy,levelsofvariabilityinpractice,abundanceofliteratureorconflictingresultswithintheliterature,theeffectoftheguidelineintermsofcostofrecommendedcare,oritsimportanceforreimbursementandpolicydevelopment(ref:PedsManual-PediatrPhysTher2013;25:257–270).

• Reasonsforsettingtopicpriorities(basedonOxman,Schünemann,andFretheim.Improvingtheuseofresearchevidenceinguidelinedevelopment:2.PrioritysettingHealthResPolicySyst.2006;4:14)

i. Problemsassociatedwithahighburdenofdisability.ii. Noexistingrecommendationsofgoodquality.iii. Astronglikelihoodthatthedevelopedrecommendationswillimprovehealthoutcomes,

reduceinequities,orreduceunnecessarycostsiftheyareimplemented.iv. Implementationisfeasible.

• Considerations(usingICFandPatient/ClientManagementasfoundation)whendiscussingtopicchoicesinclude:usingICFlanguage,followingpatient/clientmanagementprocessordescribingasingularaspect(screening,examination,classification,interventionbyoneormoreactivitiese.g.,walking,secondaryprevention),forasinglesettingoracrossthecontinuumofcare.(seeScope).

V. SCOPE

ThescopeoftheEBDisdependentupontwothings:ThebreadthanddepthoftheEBDandthetypeofEBD.Dependingonthedegreeofdevelopmentofthetopicandquestion(s)thesestepsarecomplementary.

AccordingtoRosenfeldetal.,

“Awell-craftedguidelinehasaclearlydefinedscope.Definingscopewilloccupymostofthefirstconferencecallandmayrequireasecondforcompletion.Inexperiencedguidelinedevelopersattempttocoverallaspectsofacondition,resultinginabroadscopethatwillstalldevelopmentefforts.Thekeytoprogressisarazor-sharpfocusfromthestart,recognizingthatsomeissuesimportanttosomestakeholderswillinevitablybeleftout.Cliniciansmayhavetrouble

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embracingtheconceptofafocusedguidelinewithrestrictedscopeandalimitednumberofrecommendations.Instead,thedesirewillbetoincludeabroadrangeoftopics,similartowhatappearsinatraditionalreviewarticleorbookchapter.Topicsdeemedimportantbythegroup,butnotaccommodatedintheguidelineactionstatements,maystillbediscussedinthesupportingtextorinanappendix,provideditisclearlyidentifiedasbasedonconsensusorexpertopinion.”(p.S16)

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Thefollowingfigure(Figure3)providestheprocessfordeterminingtypeofEBD.

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BreadthandDepthofEBDTodeterminethescopeoftheEBDrequiresthatquestions“WhatexactlyistheEBDintendingtoaccomplish?Whatisitsfocus?”beansweredprecisely.

Thefollowingrecommendationsandconsiderationswillfacilitatedecision-makingintheprocessofdeterminingthescopeoftheEBD:

1. Definetheintendedaudience,targetpatientsorclinicalpresentation,andthetargetconditionorprocedure(itmayincludeassessmentortreatmentorboth)andbeabletopreciselydefinetheconditionorprocedure.

a. TowhomistheEBDdirected?PTs?Allphysicaltherapyprofessionals?Allmedicalprofessionals?Etc.

b. Thetargetpatientorclinicalpresentationcanbedefinedusingdemographics,signs/symptoms,history,diagnostictests.TheWorkingGroupshouldbecleartoidentifywhatpatientsorclinicalpresentationswouldnotbeincludedintheEBD.

c. Theremaybeasingleconditionoralistofmultipleconditions.UsetheICFterminologyandmodelasabasisforthedescriptionofthetarget/healthconditions.

d. Identifythepatients’orconditions’levelwithinthecontinuumofcaretowhichtheEBDisdirected.Thecontinuumincludespracticesettingsfromacutehospitalizationtocommunity–basedprograms.Insomeinstances,therecommendationsaremoreheavilybasedinonesettingandanexplanationrelatedtothebestpracticeareatoimplementtheEBDshouldbeincluded.Furthermore,acuity(hyper-acute,acute,sub-acute,chronic)shouldalsobeaddressedwhenitispertinenttothetopicandassistsindefiningscope.

2. UsethePTmanagementmodelfromtheGuidetoPhysicalTherapistPractice(Exam,Eval,Diagnosis,Prognosis,Intervention)anddelineatehowmuchofthePTmanagementprocesswillbecoveredintheEBD.

3. Prospectivelyidentifyoutcomestoconsider.Outcomescategoriestoconsiderincludehealthstatus,functional,qualityoflife,aswellascost,qualityandutilizationoutcomes.Agreeuponstandardizedoutcomesusingbodystructure/function,activity,and/orparticipationdomainsandprovideMDCandMCIDwhereavailable.Relateinformationonthebenefit/outcometosocietyforimplementingtheEBD.(i.e.costorcost-effectivenessdata,qualityoflifeimprovements)tothestakeholders(boththetargetpatientsandthetargetaudience).

DeterminingtheTypeofEBD

TherearedifferenttypesofEBDs.ThefollowingareEBDsthathavebeendefinedbytheAPTA:

ClinicalPracticeGuideline(CPG)Clinicalpracticeguidelinesaregradedrecommendationsonbestpracticeforaspecificconditionbasedonthesystematicreviewandevaluationofthequalityofthescientificliterature.Thesedocumentsaredefinedbyastringentmethodologyandformalprocessfor

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development.Clinicalpracticeguidelinesaremadeupofbothevidence-basedandexpert-basedinformationandassuchareintendedtofacilitateinterpretationofresearchevidencetoguideclinicalpracticedecision-making(Fetters&Tilson).Althoughvariationcanexist,allmustmeetstandardcriteria.

ClinicalPracticeAppraisals(CPA)/ClinicalGuidanceStatements(CGS)ClinicalpracticeappraisalsorguidancestatementssummarizebestpracticeforanareaofclinicalpracticebasedupontheintegrationofavailableliteraturefromCPGsandexpertopinion.Thesedocumentsaredefinedbyastrongmethodologyincludingananalysisoftheavailableresearchandstructuredprocessfordevelopment.Variationmayexistbutallmustmeetstandardcriteria.

• DevelopmentofaCGSmaybeprudentwhenmultipleCPGsexistonaparticulartopic.FortheCGS,itsscopeistoappraisetheexistingCPGsandsynthesizetheCPGs’recommendationsintoacoherentsummary.TheappraisalandsynthesismayaddressmuchofthetopicandscopewithouttheneedforanewCPGandalsoprovideanopportunityforagapanalysis.Thus,whereapplicable,PT-specificactionstatementsshouldbedevelopedbasedonasynthesisoflevelsofevidenceandgradesofrecommendationsfromtheexistingCPGs.However,thegapanalysismayalsoprovidedirectivesforarefinementoftheclinicalquestionandscopeforafuturePT-specificCPG.

SystematicReview(SR)Asystematicreviewisabalancedsynthesisofevidencerelatedtoadefinedclinicalquestion.Thesystematicreviewappliesanexplicit,reproduciblemethodologyandsystematicsearchoftheliterature.Systematicreviewssearch,appraise,summarize,andidentifygapsinknowledge.UndernocircumstancedoesanSRprovidearecommendationforpractice.Clinicalpracticeguidelinesarerequiredtobridgethegapbetweenevidenceandrecommendation.

ClinicalsummaryClinicalpracticesummariesarereferencedbasedandpeerreviewedsummariesoftheevidence.Thesedocumentsdescribewhatisknownsofarandfocusonclinicalapplicationfollowingastandardformatwhichincludesoverview,classification,screening,examination,diagnosis,prognosis,intervention,medicalmanagement,andcaseexamples.ThesearepublishedonPTNow.

ProceduralsummaryAproceduralsummaryisavariationofaclinicalsummaryfornon-clinicalpopulationcontentsuchassafepatienthandling,electricalstimulation,etc.APTAhasnotformalizedadefinitionforproceduralsummarybeyondthis.TheTaskforceinterpretsthisEBDasastep-by-stepdescription.

Positionstatement/WhitepaperPositionstatementsareintendedtosetforthapositionbasedonclinicalcontentrelatedtothephysicaltherapistsscopeofpractice.Thesedocumentsarereferencedandpeerreviewed.Theyareintendedforaconsumeraudience.

PocketguidePocketguidesareshortsummarystatementsinaportabletool.Apocketguidecouldbederivedfromanyoftheabovedocuments.Whenpocketguidesaredevelopedindependentofanotherdocument,theyareintendedtobebasedonbestavailableevidenceandexpertconsensusandarereferencedandpeerreviewed.

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ConsumerdocumentsTheAPTAispresentlytalkingaboutthistypeofdocumentasacompaniontoCPGsorCGSs.

BeforethescopeoftheEBDcanbeformallydefined,thechoiceofEBDmustbeestablished.ThechoiceofEBDisdeterminedbyafirstliteraturesearchtodetermineifCPGsand/orSRsalreadyexistonthetopic.Asearchspecialist(medicallibrarian)maybeneededtoassistwiththesearchprocess.Ataminimum,NationalGuidelinesClearinghouse,GuidelinesInternationalNetwork,andstandardelectronicdatabases(using“guideline”)shouldbesearched.

• CPGrepositoriesinclude:

o http://guidelines.gov/-NationalGuidelinesClearinghouseo http://www.sign.ac.uk/-ScottishCollegiateo http://www.nice.org.uk/-Nat’lInstforHealthandClinicalExcellenceo http://www.pedro.org.au/-PhysiotherapyEvidenceDatabaseo http://www.g-i-n.net/-GuidelinesInternationalNetworko Anydiscipline-specificguidelines(looktoprofessionalorganizationwebsites)

• SystematicReviewsorothersynthesizedevidence?

o http://www.thecochranelibrary.com/view/0/index.htmlo http://srdr.ahrq.gov/-AHRQSystematicReviewDataRepository(New)o http://www.pedro.org.au/-PhysiotherapyEvidenceDatabase(PEDro)o PrimaryReferenceDatabases-(PubMed,CINAHL,etc)

OncetheinitialsearchiscompletedandthetypeofEBDhasbeenestablished,theWorkingGroup,inconsultationwiththeAdvisoryCommittee,definesandagreesuponaspecificscopefortheEBD.

ScopeReferences/Resources

FettersL&TilsonJ.Evidence-basedPhysicalTherapy.FADavis.2012.Kaplanetal.ClinicalPracticeGuideline:PhysicalTherapyManagementofCongenitalMuscularTorticollis:AnEvidence-BasedClinicalPracticeGuidelinefromtheAmericanPhysicalTherapyAssociationSectiononPediatrics.UnderreviewRosenfeldRM,ShiffmanRN,andRobertsonP.Clinicalpracticeguidelinedevelopmentmanual,thirdedition:Aquality-drivenapproachfortranslatingevidenceintoaction.OtolaryngologyHeadNeckSurgery2013148:S1.WoolfS,SchünemannHJ,EcclesMP,GrimshawJMandShekelleP,Developingclinicalpracticeguidelines:typesofevidenceandoutcomes;valuesandeconomics,synthesis,grading,andpresentationandderivingrecommendations.ImplementationScience2012,7:61

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VI. StatementofIntent

AllCPGsshouldhaveastatementofintentfollowingthescope.BoththeOrthopedicandPediatricSectionshaveusedsimilarphraseologyintheirCPGs.Asarepresentativeexample,thefollowingistakendirectlyfromtheforthcomingPediatricCPGonCongenitalMuscularTorticollis.APTAhasgenerallanguageforstatementofintentwithinCPGsaswell.

“Thisguidelineisintendedforclinicians,familymembers,educators,researchers,policymakersandpayers.Itisnotintendedtobeconstruedortoserveasalegalstandardofcare.Asrehabilitationknowledgeexpands,clinicalguidelinesarepromotedassynthesesofcurrentresearchandprovisionalproposalsofrecommendedactionsunderspecificconditions.Standardsofcarearedeterminedonthebasisofallclinicaldataavailableforanindividualpatient/clientandaresubjecttochangeasknowledgeandtechnologyadvance,patternsofcareevolve,andpatient/familyvaluesareintegrated.ThisCPGisasummaryofpracticerecommendationsthataresupportedwithcurrentpublishedliteraturethathasbeenreviewedbyexpertpractitionersandotherstakeholders.Theseparametersofpracticeshouldbeconsideredguidelinesonly,notmandates.Adherencetothemwillnotensureasuccessfuloutcomeineverypatient,norshouldtheybeconstruedasincludingallpropermethodsofcareorexcludingotheracceptablemethodsofcareaimedatthesameresults.Theultimatedecisionregardingaparticularclinicalprocedureortreatmentplanmustbemadeusingtheclinicaldatapresentedbythepatient/client/family,thediagnosticandtreatmentoptionsavailable,thepatient’svalues,expectationsandpreferences,andtheclinician’sscopeofpracticeandexpertise.TheGDGsuggeststhatsignificantdeparturesfromacceptedguidelinesshouldbedocumentedinpatientrecordsatthetimetherelevantclinicaldecisionsaremade.”

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VII. CRITICALAPPRAISALOFTHEEVIDENCEandLEVELSOFEVIDENCE

CriticalappraisalrequirestheSECONDLITERATURESEARCHandisusedforthedevelopmentofCPGs,CGSs,andSRs.Oncethescope(s)usingPICOformathasbeenestablished,theWorkgroupperformsasecondliteraturesearch.Theobtaineddocumentswillthenbeappraisedfortheirquality.

Assumptions:

1. the“PICO”questionthatthegroupwantstoaddresshasbeenclearlydefined2. keyconceptualdefinitionsrelevanttotheproposedEBDhavebeenclearlydefined

Steps:

1. Preparation:Cleardelineationofinclusionandexclusioncriteriaforpotentialstudies

Examples:

• agerange,gender,andethnicityofsubjects• samplesize• medicalconditionsallowed• leveloffunction(ICFWHO)oracuitylevelofsubjects• studysetting(community,acutecare,rehabilitation,subacutecare,longtermcareetc)• studyintent(diagnostic,prognostic,efficacyofintervention,epidemiological,instrument

development/clinometric,etc)• studydesign(crosssectional,longitudinal,descriptive,quasi-experimental,experimental)• typeofstatisticalanalysis(relationship,difference,descriptive,predictiveetc.)• language(Englishonly,unlessmedicaltranslatorsareavailabletotheteam)• daterangeforstudies

2. Search:Decisionsaboutwhichdata-basestouseanddevelopmentofkeysearchterms.GuidanceofaMedicalLibrarianisveryhelpfulatthisstep.

• MeshheadingsforPubmed(mostuptodatewithepubs)orMedline• CINAHLtendstocapturemoreofrehabliterature• PEDroforPToutcomestudies/RCTs• Booleanoperators:useofquotations,parentheses,roots*,AND,OR,NOT

(note:goalatthispointistobeasinclusive/broadaspossible)

3. Search:Conductthesearch

• Setupexceldatabasetokeeptrackofeachabstractthatmightpotentiallybeincluded(headings:primaryauthor,co-authors,title,journal,year,citation,othersasdeterminedbyintentofsearch)

• WorkGroupChairisthekeeperofthisfile.Notenumberofduplicatesifmultiplesearchesareundertaken

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• Recordeverypotentialabstractinthedatabase(decisionsaboutinclusionarethenextstep)• Retrieveandsaveabstractsintolimitedaccesse-storage(GeriEDGEcutandpasted

abstracts,savingfilesbyprimaryauthorlastname,year,andjournalabbreviation;andstoredtheminadropboxfolderaccessibleonlytomembersoftheteam

4. AppraiseAbstracts:Evaluatetheabstractsbasedoninclusionexclusioncriteria

• Definejudgmentcategories:ex:retrieve,exclude,“datamine”(ifarticlereferencesmightyieldadditionalabstracts)

• Establishreliabilityofthereviewprocessbyhavingallreviewteammembersreviewthesamesmallsetofabstractsindependently,thendiscusstheprocessforclarificationandconsensus

• Assignasetnumberofabstracts(alphabetically)toeachteamof(2)reviewers.Eachreviewerevaluatesabstractsindependently.

o Developaformbasedoninclusion/exclusioncriteriathatreviewerscouldusetorecordwhytheymadetheirrecommendationsforeacharticle.

o ProvideExcelfilecutandpastedfromthemasterwiththecitationseachpairwasassignedtouse.Pairscometoconsensusoneachassignedabstract.Ifthisisnotpossible,theWorkGroupChairresolves.

• WorkGroupChairrecordsteamdecisionsonthemasterfile• Retrievearticlesthatmetinclusioncriteria.Savepdfsina“ArticlestobeReviewed”file

(savethembyprimaryauthor,year,journalabbreviation)• Retrievearticlesthatfellinto“datamine”category;reviewreferencestitles,andretrieve

abstractsthatappeartobeinformative;putthesethroughtheabstractreviewprocess

Note:Whenthesecondliteraturesearchresultsinalargenumberofdocuments,theWorkGroupmaywanttoincludeadditionalvolunteersforthecriticalappraisalprocess.TheWorkGroupshouldprovideanorientationandtrainingsession(s)regardingbackgroundtotheprojectandthespecificcriticalappraisalprocess.ReliabilityshouldbeestablishedforeachcriticalappraisaltoolusedwithinthedevelopmentoftheEBD.TheWorkGroupwillneedtoestablishanacceptablelevelofreliability.Werecommenda90%agreementamongappraisers.Consensuscanbeestablishedthroughdiscussion.TheWorkgroupwillberesponsibleforresolvinganyscoringdiscrepancies.

5. Evaluatethearticlesbasedontheappropriatecriticalappraisaltool

• Establishreliabilitybyhavingentirereviewteamindependentlyreviewandrateseveralarticles.Usediscussionofprocessandcometoconsensusonoutcome.Thisshouldbeaccomplishedinoneconferencecall.

• Assignasetofretrievedarticlestoateamof2reviewers.Eachreviewerevaluatesarticlesindependentlythenmustcometoconsensuswithteam.

• Criticalappraisalwhentheevidence-baseddocumentofchoiceiseitherasystematicrevieworaclinicalpracticeguideline.

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• Appraisingindividualstudies:Therearenumerousevidenceappraisaltools.Center

forEvidencebasedmedicine(CEBM)andScottishIntercollegiateGuidelinesNetwork(SIGN)providetoolsforSRs,RCTs,Cohort,Casecontrol,andDiagnosticstudies.FromCEBM

! http://ktclearinghouse.ca/cebm/teaching/worksheets

FromSIGN! http://www.sign.ac.uk/methodology/checklists.html

CaseSeriesStudies:TheInstituteofHealthEconomicsinAlberta,Canadahasdoneextensiveworkoncriticalappraisalofcaseseriesstudies.Theydevelopedan18-pointappraisaltoolandusea70%cutoffscoreforratinghighqualitystudies.

http://www.ihe.ca/publications/library/2012-publications/development-of-a-quality-appraisal-tool-for-case-series-studies-using-a-modified-delphi-technique/(accessed1/2014)

http://colloquium.cochrane.org/fr/abstracts/development-quality-appraisal-tool-case-series-studies(accessed1/2014)

InterventionStudies:TheAPTAhasdevelopedacriticalappraisaltoolforexperimentalinterventionstudiesandAPTAisencouragingitsuseinallevidence-baseddocumentinitiatives.

MeasurementStudies:Consensus-basedstandardsfortheselectionofhealthmeasurementinstruments(COSMIN)providesatoolspecifictohealthmeasurements.However,thisisaverydensetoolandmayposechallengesfortrainingvolunteerreviewers.

FettersandTilson(2012)withintheirtext,discussandprovideappraisaltoolsacrossthedifferenttypesofstudies:(http://www.fadavis.com/product/physical-therapy-practical-guide-evidence-based-practice-fetters-tilson)

TOOLRECOMMENDATION:TheTaskForcerecommendsthattheAPTACriticalAppraisalToolforExperimentalInterventionStudiesbeusedforallrandomizedcontrolledtrials.WorkgroupsshouldassistAPTAwithvalidationoftheAPTA’sCriticalAppraisalTool.AsSectionsandworkgroupsadoptthistool,thereisalsothepotentialforthedevelopmentofacentralrepositoryofcritically–appraisedinterventionstudies.Atthistime,appraisaltoolsdevelopedbyFetters&Tilson(2012)shouldbeusedforallotherstudies.TheTaskForceevaluatedtheInstituteforHealthEconomics’criticalappraisaltoolforcaseseriesstudiesandfeltitsusewouldbevaluableinsituationswhereatopic/PICOquestion(orsub-question)was

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answerableonlybyamajorityofcaseseriesevidence.However,appraisalofthistypeofstudywouldresultinaLevelIVlevelofevidence(seeLevelsofEvidencebelow)irrespectiveoftheoutcomeofthecriticalappraisal.

• Appraisingsystematicreviews:Appraisingsystematicreviewswillberequiredwhentheevidence-baseddocumentofchoiceisaclinicalpracticeguideline.

TOOLRECOMMENDATION:TheTaskForcerecommendsusingAMSTARforthecriticalappraisalofsystematicreviews.

http://www.nccmt.ca/registry/view/eng/97.html

• Criticalappraisalwhentheevidence-baseddocumentofchoiceisaclinicalguidancestatement.

• Appraisingclinicalpracticeguidelines:ThebesttoolforappraisingCPGsatthistime

istheAGREEIIdocument.AllCPGsshouldbeappraisedusingAGREEII.Atleast3(preferablyall)membersoftheWorkgroupshouldrevieweachCPGusingAGREEII.TrainingforAGREEIIisavailablehere:

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

http://www.agreetrust.org/resource-centre/agree-ii-training-tools/

Iftimeandresourcesarelimited,thenanew,shortversionoftheAGREEII(AGREEII–GRS)documentmaybeconsidered.EachWorkGroupincommunicationwiththeAdvisoryCommitteeshoulddecidewhichversionoftheAGREEIIdocumentshouldbeused.

http://www.agreetrust.org/resource-centre/agree-ii-grs-instrument/

• Inter-raterreliabilityshouldbeestablishedonasampleCPG.ConsensusshouldbeestablishedbyphonecallonallCPGscores.

• Scorecriteriaforeachpaper.Thiswillbeusedtodeterminelevelofevidence(e.g.,LevelIversusLevelII)

6.ScoresfromthecriticalappraisalarelinkedtoLevelsofEvidence.

• TheTaskForcerecommendstheuseoftheCEBMnomenclatureforLevelsofEvidence.TheCEBMnomenclaturehasbeenadaptedbytheOrthopedicsandPediatricsSectionsandispresentlybeingusedbytheVestibularCPGGroup.ThefollowingindicateshowthePediatricCPGonCongenitalMuscularTorticollisintegratedcriticalappraisalscoresintoLevelsof

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Evidenceusinga>or<50%score.OrthopedicsSectiondidnotprovidecriticalappraisalscoreinformation.

I Evidenceobtainedfromhigh-qualitydiagnosticstudies,prognosticorprospectivestudies,cohortstudiesorrandomizedcontrolledtrials,metaanalysesorsystematicreviews(criticalappraisalscore>50%ofcriteria).

II Evidenceobtainedfromlesser-qualitydiagnosticstudies,prognosticorprospectivestudies,cohortstudiesorrandomizedcontrolledtrials,metaanalysesorsystematicreviews(eg,weakerdiagnosticcriteriaandreferencestandards,improperrandomization,noblinding,<80%follow-up)(criticalappraisalscore<50%ofcriteria).

III Case-controlledstudiesorretrospectivestudiesIV CasestudiesandcaseseriesV Expertopinion

• THRESHOLDRECOMMENDATION:TheTaskForcerecommendsadoptingthe50%thresholdforappraisalsofindividualstudiesonly.o Backgroundonmakingthisrecommendation:

o Presently,therearenumerousandvariableapproachestocriticalappraisalwhichisalsodependentuponthetypeofindividualstudy.Thereisnoestablishedstandardfororconsensusonchoosing50,60,or70%cutofffordelineationofhigherversuslowerlevelofevidence.However,onegroup,theInstituteofHealthEconomicsinAlberta,Canadahasdoneextensiveworkoncriticalappraisalofcaseseriesstudies.Theydevelopedan18-pointappraisaltoolandusea70%cutoffscoreforratinghighqualitycaseseriesstudies.

o TheTaskForcedebatedthisissuequiteextensivelyandcametotheconclusionthat50%wasaprudentthresholdatthistime.Withsomuchvariability,ourintentionistoerroronthesideofinclusionwiththe50%recommendation.However,asthescienceofcriticalappraisalevolves,theAdvisoryCommitteeshouldperiodicallyre-visitthisissue.

• TheTaskForcedoesnotrecommendusingathresholdforappraisalsofCPGs(whentheEBDofchoiceisaCGS)

o AGREEIIprovidesforascaleddomainscore.However,theAGREEIIConsortiumstates“Althoughthedomainscoresareusefulforcomparingguidelinesandwillinformwhetheraguidelineshouldberecommendedforuse,theConsortiumhasnotsetminimumdomainscoresorpatternsofscoresacrossdomainstodifferentiatebetweenhighqualityandpoorqualityguidelines.ThesedecisionsshouldbemadebytheuserandguidedbythecontextinwhichAGREEIIisbeingused.”(p.13ofBrouwersetal).Assuch,theTaskForcedoesnotrecommendaformalthresholdbeestablishedwhenevaluatingCPGsfortheirinclusioninaCGS.MoreappropriatelybasedonthepurposeoftheCPG,aWorkGroupshoulddecidetoincludeonlyhighqualityCPGsandthisshouldbeaccomplishedbyconsensusdiscussionfollowingappraisalusingAGREEII.

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7. Extractinformationfromthearticlesthatmeetqualitycriteriatoinformthedevelopingevidence-baseddocument.EnterintoanEvidenceTable.ThisstepisdiscussedinthenextsectiononWritingRecommendations.

8.Synthesizeevidenceacrossretrieved/appraisedstudiestocometoconsensusaboutrecommendationforclinicaluse.

• Useofateamdiscussion/consensusbuildingisrecommended• Make“strengthofevidence”determinationforrecommendationforclinicalusebasedon

thecriteria/formatgrouphaspreviouslyagreedupon.

References/Resources

BrouwersM,KhoME,BrowmanGP,CluzeauF,federG,FerversB,HannaS,MakarskiJonbehalfoftheAGREENextStepsConsortium.AGREEII:Advancingguidelinedevelopment,reportingandevaluationinhealthcare.CanMedAssocJ.Dec2010,182:E839-842;doi:10.1503/cmaj.090449FettersL&TilsonJ.EvidenceBasedPhysicalTherapy.FADavisCompany.2012.KaplanSL,CoulterC,FettersL.ClinicalPrracticeGuideline:physicaltherapymanagementofcongenitalmusculartorticollis:anevidence-basedclinicalpracticeguidelinefromtheAmericanPhysicalTherapyAssociationSectiononPediatrics.UnderReview.

MogaC,GuoB,SchopflocherD,HarstallC.DevelopmentofaQualityAppraisalToolforCaseSeriesStudiesUsingaModifiedDelphiTechnique.EdmontonAB:InstituteofHealthEconomics.2012.

SheaBJ,GrimshawJM,WellsGA,BoersM,AnderssonN,HamelC,PorterAC,TugwellP,MoherDandBouterLM.DevelopmentofAMSTAR:ameasurementtooltoassessthemethodologicalqualityofsystematicreviews.BMCMedicalResearchMethodology2007,7:10

SheaBJ,HamelC,WellsGA,BouterLM,KristjanssonE,GrimshawJ,HenryDA,BoersM.AMSTARisareliableandvalidmeasurementtooltoassessthemethodologicalqualityofsystematicreviews.JClinEpidemiol.2009Oct;62(10):1013-20.

WoolfS,SchünemannHJ,EcclesMP,GrimshawJMandShekelleP,Developingclinicalpracticeguidelines:typesofevidenceandoutcomes;valuesandeconomics,synthesis,grading,andpresentationandderivingrecommendations.ImplementationScience2012,7:61.

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VIII. STRATEGIESFORDATASTORAGE,DATAEXTRACTIONANDSYNTHESISOFFINDINGS

Foranytypeofevidence-baseddocumentbeingdevelopedbyaworkgroup,thenextstep(afterarticleshavebeenretrievedandcriticalappraisaliscompleted)istoextractrelevantinformationfromeacharticle,andbegintheprocessofsynthesis.

DATASTORAGEAmechanismforliteratureanddocumentstorageshouldbeestablished.Workgroupmemberswillbeperformingsearches,appraisals,andsoonbegindraftingtheEBDanditsassociatedsections.Aclear,easilyaccessibledocumentstoragespacewillassurethateachworkgroupmemberhasthetoolsnecessaryforthesetasks.Recommendations/considerationsinclude:

• Establishhowabstracts,articles,andotherdocumentswillbeorganized.Someprogramstoconsiderare:

o Googledocso Mendeleyo Endnoteo Zoteroo DropBoxo Hardcopy

• Considerdifferentcapabilitiesoftheprogram/software:

o Accessibleandconvenienttotheuserso Organizationcapabilities,includingaddinginformationovertimeo Easeofinformationretrievalo Efficientmeansofpreventingduplicateentries;onemainrepositoryo Flexibilityofthesystem,ie.abilitytoattacha.pdfdocumento Costmaybeaconsideration

• Somefeedbackfromprevioususersinclude:

o Googledocs:! Differentversionsofamanuscriptweresaved,anditwaschallengingtokeep

trackofthemostrecent;web-basedo Mendeley:MendeleyReferenceManagerforarticles

! Freeversionhaslowstoragecapacity;$5-10/moextrafor>3peopleandformorethan~150articles

! Haspotentialformultipleprojectswithvariouscollectionsofarticlesforeacho Endnote:

! Costtoastudent=$180! HasInternetcapability-cansynctodesktoporworkcomputer! Softwareexpiresaftersometimeduetonewversions! SomeversionscannotholdPDFs,andsomereportedtroublewithupdatingthe

mostrecentversiono DropBox

! Providedlimitedaccesstothegroup(whenthisisneeded)

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• Regardlessoforganization/storagesystem,keeptrackofthesearchhistoriestocompileforthe

Methodssectionorafuturerevisionworkgroup

• Namefileswithconsistentformat.Forexample,useof“author’slastname_year_keyword”canmakearticleseasiertofind

• Establishamethodtoprovideworkgroupmemberaccesstofull-textpublications,asappropriate.Allgroupmembersshouldhaveaccesstothedatabaseofallabstracts.Copyrightlawsmaypreventsharingthefullcollectionofarticlestoall.

DATAEXTRACTION

Mostresourcesonevidence-baseddocumentsrecommendthattheteamleader/reviewcoordinator,inconsultationwiththeworkgroup’smethodologistorstatistician,clearlydefinethenecessarypiecesofinformation(datapoints)tobeextractedfromeacharticleinordertoanswertheguidingPICOquestionthatisthefoundationfortheevidence-baseddocument.

Dataextractionformsforevaluationofinterventioneffectiveness,forexample,mightincludeatleastthefollowingpiecesofinformation:

• StudyIDnumber(assignedbyreviewcoordinatorforeacharticle)• Dataextractorinitials• Datedataextractioncompleted• CompleteReferenceasfollows

o PrimaryAuthoro SecondaryAuthorso FullTitleo Journalo Yearo Volume(Issue):pagerange

• Objective—thestudyobjectiveasstatedbytheauthors• Articletype/studydesign:e.g.,metaanalysesorsystematicreviews,diagnosticstudies,prognostic

orprospectivestudies,cohortstudiesorrandomizedcontrolledtrials,case-controlledstudies,retrospectivestudies,casestudiesandcaseseries,orexpertopinion.Note:Thiswillinformdecisionsaboutoflevelsofevidence.

• LevelofEvidence(describedearlier)• CriticalAppraisalToolSummaryScore.• Population—demographicsoftheparticipantsinthestudy• Intervention—descriptionoftheintervention• Control—descriptionofthecontrolgrouporalternativeintervention• Outcomemeasuresused• Typesofanalysesperformed• Resultsoftheintervention• Studylimitations

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Itisimportanttonotethatthereisnosingletemplatefordataextraction:thecontenttobeextracteddependsonthePICOquestion/sunderlyingtheEBDdevelopmentgroup’sgoalsandpurpose.Oncekey“datapoints”aredefined,theteamleaderandmethodologistmustdecidehowandwhentheinformationtobeextractedwillbedocumentedandstored.Atimelineforcompletionshouldbedeveloped.

DataExtractionOptions

Thereareanumberofoptionstoconsiderincollectingandmanagingthe“data”extractionprocess,eachwithitsownprosandcons:

• “Paperandpencil”orstandardizedformsavailableasWorddocumentsorfunctionalPDFforms.AnexampleofthistypeofdataextractiontoolistheformdevelopedbytheSectiononResearchEDGEgroupandusedbythevariousNeuroEDGEsubgroups;itwasdesignedtogatherinformationonvalidity,reliability,andmeasurementcharacteristicsoffunctionalmeasuresusedtodocumentoutcomesinphysicaltherapycare(http://www.ptresearch.org/article/84/resources/researchers/edge-task-force-evaluation-database-to-guide-effectiveness/edge-rating-forms).

Eachreviewercompletesoneformforeveryarticleonhisorherassignmentlist.Mostresourcesondevelopmentofevidence-baseddocumentsrecommendthattworeviewersindependentlygatherrelevantinformationfromeacharticle,compareresults,andcometoconsensus/agreementthatallkeyinformationhasbeenextracted.Thisstrategyhelpstoreducepotentialbias,aswellasimprovereliabilityduringdatacollection.Followingconsensus,thedocumentcanbeemailedtothereviewcoordinator,whothenperformsordelegatesdataentryintoanexcelfileorotherdatabaseforfurtheranalysis.

• Spreadsheets/DataTables:ToolssuchasMicrosoft’sExcelprogramorGoogleDocsopenaccessonlineprogramscanbedevelopedtomeetthespecificneedsoftheworkgroup.Thedecisionmustbemadeaprioriaboutwhetherreviewersenterdatadirectly,oruse“pencilandpaper”togatherinformationthatasingleassignedperson(e.g.,teamleaderorreviewcoordinator)entersextracteddataintothespreadsheet.Ifthenumberofreviewersisrelativelysmall,enteringdatadirectlymaybemanageable.Ifthenumberofreviewersislarge,theriskofdataentryerrorsincreasessubstantially.Additionally,spreadsheetswithmanycolumnsandrowsofinformationtocompletecanbecumbersomeandconfusing;thiscontributestoriskofdata-entryerrors.

• Databasesoftware:ToolssuchasMicrosoftAccessprogramcanalsobedevelopedtomeetthespecificneedsoftheworkgroup.Bysettingupaseriesofscreensbycontentinformation(e.g.,citationinfo,samplecharacteristics,studydesignandstatisticalanalysis,methodologicalquality,measuresused,interventiondetails,conceptual&operationaldefinitions/outcomemeasuresused,results,etc.asappropriateforthePICOquestion),riskofdataentryerrorsisgreatlyreduced.Thistypeofdatabasealsoallowsmultiplepersonstohaveaccess,andcanbemodifiedasnecessarytomakedatagatheringmoreefficient.ThereisasignificantlearningcurvefornewAccessusershowever;thisoptionwouldworkbestifsomeoneinthegroupwasalreadyfamiliarandfacilewith

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thesoftwareprogram,oriftherewasfundingtohireanexperttodevelopthemulti-layerinterfaceandtraingroupmembersinitsuse.

• Web-basedSurveys:SurveyMonkeyhttps://www.surveymonkey.comisaweb-basedtoolthatcouldbeusedtodesignadataextractionform.Theteamleader/reviewcoordinatorwouldneedtodesignasurveythatreviewerteamscanrespondtoforeachoftheirassignedarticles.Answerformatcouldbedesignatedasacombinationoffreetextorforcedchoiceoptions.Managementofdatacanbecumbersomeifmanyarticlesaretobeminedforinformation.Surveyresultscanbedownloadedbytheteamleader/reviewcoordinatorintoadatabase,suchasExcel.Thisworksefficientlyonlyifresponseoptionsarewellunderstoodandconsistentacrossthereviewteam.Notethatthereislikelytobeacostforadvancedsurveytools.

• FreeOnlineDatabasesandSoftware:TheCochraneCollaborationhasdatamanagementandanalysissoftware,RevMan(ReviewManager5.3)availablefordownloadforresearchersinvolvedindevelopingsystematicreviews.Itmayalsobeusefulforothertypesofevidence-baseddocumentsaswell.http://tech.cochrane.org/revman.CochranealsohasGRADEprosoftwarethathelpstocreatethesummaryoffindingtablesnecessaryforthesynthesisprocess.http://tech.cochrane.org/revman/gradepro.UsersareabletotailortheirdataformsbasedonthetypeofquestiontheirEBDistryingtoanswer:effectivenessofintervention,diagnostictestaccuracy,methodologyreview,overview,orflexible(prognosis,qualitative,orprototype)review.Oncethetypeofreviewisidentified,thesoftwarehasadefinedsetofinformationtogather.Tables,figuresandappendicescanbedownloadedintoRevMan.TheAPTAisintheprocessofevaluatingacriticalappraisal/datacollectionformforstudiesofphysicaltherapyintervention/outcomestudies.

• FeeforServiceWeb-BasedDatabasesandSoftware:Whentherearemanyarticlesfromwhichdataneedstobeextracted,orwhentherearemultiplepersonsinvolvedinthearticlereviewanddataextractionprocesses,thereareonlineservicesthataredesignedtoassistdatamanagementforcomplexreviews.DistillerSR(http://distillercer.com/products/distillersr-systematic-review-software)isanexampleofonesuchservice

Nomatterwhichstrategyisselectedfordataextraction,theinitialdraftofthe“form”needstobeevaluatedandrevisedsothatitisefficientandeffective.Manydataextractionformsundergoseveraliterationspriortoimplementationinafinalversion.Evaluationoftheformisachievedbyhavingseveralknowledgeablereviewersuseiton“practice”articles,focusingattentiononclarityofinstructions,easeofuse,andidentificationofredundantandmissinginformation.Theiterativefeedbackprovidedbyactualuseisinvaluable,insuringthatthedataneededtosupportsynthesisisavailableinaconsistent,interpretable,andhighqualityformat.

TrainingforDataExtraction

Oncethedataextractionstrategyand“form”arefinalized,theindividualswhowillbeextractingdataneedtobetrainedsothatthereisasconsistency(andthereforelessriskoferror)acrossthereviewteam.Becausethereisgreatvariabilityinhowauthorspresentinformationanddescribemethodsandresultsacrossjournals,effectivedataextractioncanbeverychallengingandtimeintensive.Havingdataextractors“practice”onthesamearticleorsmallsetofarticlesfollowedbydiscussiontoreachconsensusmaybeasolidstrategytodevelopinter-raterreliability.Itisveryhelpfultohavea

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manual/dictionarythatindividualscanrefertoastheymovefromnovicetoexperienceddataextractors.

Aftertheteamleader/reviewcoordinatorissatisfiedthatthereisconsistencyinprocessandcontentacrossreviewers,pairsofreviewers(ideally)areassignedasetofarticlesfordataextraction.Eachindependentlycompletesdataextractionthencomparesresultswiththeirteammate.Onceconsensusisreached,thefinaldatasetforthatarticleisrecordedinthedataextraction/datamanagementtoolthathasbeenchosen/developedfortheproject.Iftherearemanyarticlesfromwhichdatamustbeextracted(andifdataextractorsareexperienced),analternativeisto“spotcheck”,havingsingledataextractor,withaplanneddualconsensusevaluationonevery15thor20tharticle.

ManagingtheDatabase

Errorsindataentryinacomplexdatabasearelikely,nomatterhowcarefulorexperiencedtheindividual/senteringdataare.ItisimportanttothinkabouttheEBDdatabaseinthesamewayonewouldaresearchdatabase.Dataextractionforms,the“raw”datausedfordevelopmentofEBD,shouldbesavedinane-folderaccessibletotheindividualontheteamdesignatedasthedatabasemanager.Thispersonshouldperiodicallyusesortoptionstoscanforoutofrangeorunusualvaluesinanygivencolumn,referringbacktothe“raw”datatomakecorrections.Oncethedatabasemanagerissatisfiedthatinformationinthedatabaseisaccurate,theteamisreadytomoveintotheprocessofsynthesis.

SortingInformationintheDatabase

Inorderforthegrouptobeabletosynthesizeevidencecontainedinthedatabaseofextracteddata,itisnecessarythatasortingprocessoftheinformationispossible.Inthisway,informationrelevanttospecificcomponentsofthePICOquestioncanbegrouped.Itmaybenecessarytoaddcolumnswithinthedatabasesothatcodingwillallowanefficientsortingprocess.Sortingofthedataprovidesthefoundationfordevelopmentofdata/evidencetablesasthesynthesisprocessbegins.

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DATASYNTHESIS(MAKINGRECOMMENDATIONS)

Thequalityofanevidence-baseddocumentisdeterminedbythetransparencyandeffectivenessofthesynthesisprocess.JustasintheearlierstagesofEBDdevelopment,riskofbiascanbereducedbyuseofaconsensusbuildingstrategy.Therearenohardandfastrulesaboutthesynthesisprocess.AfterreviewingstrategiesusedbyEBDworkgroupsfromAPTASectionsofOrthopedicsandPediatrics,aswellasmethodologyfromEBDworkgroupsfromotherdisciplines,werecommendthat2-4individuals(dependingonscopeofdocument)beassignedtodraftasynthesisoutline,presenttheiroutlinetothegroup,andthenuseaconsensusorDelphi-typeprocedureforratificationbylargergrouptoensurethatpossibilityofbiasisminimal.AdescriptionoftheDelphimethodcanbefoundat(http://www.healthknowledge.org.uk/public-health-textbook/research-methods/1c-health-care-evaluation-health-care-assessment/use-delphi-methods

Inclinicalpracticeguidelines,inparticular,andotherevidencebaseddocuments,synthesizedinformationleadstoaclinicalrecommendationor“grading”.Oneexampleofaprocesstodeveloprecommendationsisthe“GRADE”process(GradingofRecommendationsAssessment,Development,andEvaluation)(seeGuyattG,etal.JClinicalEpidemiology,2011,64:383-394),developedbyaninternationalcollaborationasatransparentandstructuredmethodforpresentationofsummariesofevidenceanddevelopingrecommendations.GRADEmethodologywasdevelopedtoanswerquestionsconcerningalternativemanagementstrategies,interventions,orhealthpolicies.

StepsintheSynthesisProcess

ThesynthesisprocesshasmultiplestepsthatmustbecarriedoutforeachPICOquestionthathasinformedthesearchforevidence:

• ForallEBDs:o Carefullydetermining/gradingthestrengthoftheevidenceofeachofthearticlestobe

includedintheevidence/datatable.Thiscanbeaccomplishedusingaconsensusprocess,orbyasinglegroupmemberwithexpertiseinresearchmethodology.

o Generationofa“bestestimate”ofeffectsaswellasanindexofuncertainty(e.g.Confidenceintervalsassociatedwiththeestimate).

o ReviewofthedocumentbytheAdvisoryCommitteeandExternalReviewerso Incorporationofrecommendationsforreviewgroupsintothedocument

• ForCPGs:

o Developmentofevidence/datatables(evidenceprofiles)usinginformationinthemasterdatabase(includingqualityratingforeachstudy).SeenextsectiononEvidenceTables.

o Reviewofinformationinthedata/evidencetabletoidentifypotentialrecommendations.

o Decidingaboutthedirection(pro/con)andstrength(strong/weak)oftherecommendation.SeeEvaluating/GradingEvidencebelow.

o Reachingconsensusoneachrecommendationwithintheentireworkgroup.SeeBRIDGEWizsectionbelow.

o Synthesizingrecommendationsintoasingledocument.

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• ForSRs:

o Developingsummaryoffinding(SOF)table.SOFtablesareashorterdistillationofthelargerevidencetables,focusedonfindingsthatmakekeyinformationmoreaccessibletoreaders.SOFtablesareincludedintheSRdocument,providingasummaryofkeyinformationonwhichasynthesisdecisionorclinicalrecommendationismade.

o Reviewofinformationinthedata/evidencetabletopreparesummaryoffindings.o NorecommendationsaremadeinaSR.

EvidenceTables(DataTables,EvidenceProfiles,SummaryofFindingTables)

EvidencetablesaredevelopedtobeabletoanswerthespecificPICOquestionsposedaswellasscopeofthedocumentbeingdevelopedbytheEBDdevelopmentworkgroup.Theinformationincludedinanevidencetableisselectedfromthecompleteddatabasefollowingdataentry.AworkgroupdevelopingasystematicrevieworCPGaimedatidentifyingwhichoutcomemeasureorcombinationofmeasuresprovidesthebestinformationaboutchangeinfunctionallocomotionforpersonswithstrokemightdesignadatatablethatcouldbeusedforeachoutcomemeasureidentifiedinthesearchandreviewprocess.Aworkgrouplookingspecificallyatbest-practiceinterventionsfordevelopingposturalcontrolnecessaryforindependentsittinginpersonswithquadriplegicandhighparaplegicspinalcordinjurymightchoosetogroupinterventionswithinasingleevidencetable.Agrouplookingatphysicaltherapyforaspecificdiagnosisormovementdysfunctionfromtheviewpointofanepisodeofcare(fromreferraltodischarge)mightorganizetheirdatabythecategoriesoftheAPTA’spatient-clientmanagementmodel

Evidencetablescanbedevelopedeitherinexcelworksheetformat(whichallowssorting)orasaworddocument.Someofthedatacanbecutandpastedfromthemasterdatafile,oncedataextractioniscomplete.Thefirstrowinanevidencetablecontainstheheadingsofinteresttothegroup.Inastudyfocusingoninterventioneffectiveness,forexample,headingsmightinclude:

• PrimaryAuthorName,• Yearofpublication• Class/Levelofevidence• StudyPopulation(n,gender,meanage,dxasappropriate)• Intervention• Outcomemeasures• Strengthofresults.

Eachstudythathasbeenretrieved,criticallyappraisedand“datamined”wouldhaveitsownrowinthetable.Thesummarystatementconsidersthe“evidence”presenteddownthecolumnsoftheevidencetable.UsefulreferencesaboutbuildingevidencetablesincludeAppendix5intheAmericanAcademyofNeurology2011ClinicalPracticeGuidelineProcessManual(St.Paul,MN)p.41,:TheAmericanAcademy

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ofNeurology;Mlika-Cabanneetal,Sharinghardlabour:developingastandardtemplatefordatasummariesinguidelinedevelopment.BMJQualSaf2011;20:141-145.)

EvaluatingandGradingtheQualityoftheEvidence

TheworkgroupischargedtodeterminethestrengthofeachPICOquestionrecommendation(andtheirrelatedactionstatements)basedonthelevelofevidenceavailableintheliterature.ThegradeassignedtotherecommendationinformsthelanguageofactionstatementsrelatedtoPICOquestion.NotethatrecommendationsofB,C,D,orE(aimedatclinicians),mayalsobeaccompaniedwithanRgrade(aimedatclinicalresearchers).Thekeytodraftingarecommendationstatementisthatitisactionableratherthansimplyastatementoffact.Thefollowingisintendedtoprovidesomeguidanceontheactionverbusagewithrespecttothegradesofrecommendations.

• A-Strongimpliesa“must”or“should”recommendationthatrepresentsbest/optimalclinicalpractice(i.e.,stateoftheart/topofthechart!).Thisrecommendationisclearlyaimedattranslatingtop-notchevidenceintoclinicalpracticetoimprovepatientcare.Thestrengthoftheevidencemightsuggestthatmoreresearchinthisareamaynotaddadditionalunderstandingtowhatisalreadyknown.

Thedecisiontouse“must”vs“should”isbasedonthediscussionandconsensuswithintheGDG.Ausefulreferenceonthisissueis:Lomatanetal.,How“Should”WeWriteGuidelineRecommendations?InterpretationofDeonticTerminologyinClinicalPracticeGuidelines:SurveyoftheHealthServicesCommunity.QualSafHealthCare.2010December;19(6):509–513.doi:10.1136/qshc.2009.032565.

FromLomatanetal:““Must”clearlydefinesthehighestlevelofobligation,butweanticipateonlyrareusageoftheterm…Useof“must”or“mustnot”maybelimitedtosituationswherethereisaclearlegalstandardorwherequalityevidenceindicatesthepotentialforimminentpatientharmifacourseofactionisnotfollowed.“May”isanappropriatechoiceforthelowestlevelofobligation.Wesuggestavoidinganyexpressionusing“consider”…

“Should”isthecommonestdeonticverbfound…andisanappropriatechoicetoconveyanintermediatelevelofobligation.Alternatively,theintermediatelevelcouldbestratifiedinto“should”and“isappropriate.”Overlappingrangesofobligationmaybeacceptableaslongasguidelinedevelopersmakeexplicittheconnectionbetweendeontictermschosenandtheirintendedlevelofobligation.Onestrategywouldbetolinkdeontictermstogradesofrecommendationstrength.Inthisapproach,thenumberofdeontictermsusedwoulddependontheparticulargradingsystemappliedbytheguidelinedevelopers.”p.513

• B-Moderateimpliesa“should”or“isappropriate”recommendationthatsupportsbutmightnotquitefullyrepresentbest/optimalpractice(i.e.,thereissomeroomforimprovement).This

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recommendationisaimedatchangingclinicalpractice,butalsoidentifieswhere“holes”inexistingevidencemayexistthatneedtobeaddressedbyclinicalresearcherstomovethefieldtowardbest/optimalclinicalpractice.

• C-Weakimpliesan“isappropriate”or“may”recommendationthatrepresentsbetter(butnotquitebest;thereisdefinitelyroomforimprovement)clinicalpractice(i.e.,thereisaclearneedforfurtherresearch).Whileitaimstoimprovepractice,italsochallengesclinicalresearcherstoprovidebetterevidencesuchthatbetterevidencecanbedevelopedsothatthegrademayimproveinfuturerevisionsoftheguideline.

Theuseof“may”whenassociatedwithgradesC,D,andEandIII,IV,andVlevelsofevidencesuggeststhattheGDGbeverycarefultodiscussbenefits/harmsandvaluesintheactionstatementprofile.Higherlevelsofevidenceandstrongergradesofrecommendationsimplyaclearbenefit-harmimpactwhilelowerlevelsofevidenceandlowergradesimplythatthebalancebetweenbenefitsandharmsplaysagreaterroleindecisionmaking.Towardthatend,theclinicianmustespeciallybeabletoweighthebenefits/harmsandpatientvaluesinthesecircumstances.

• D-Theoretical/Foundationalimpliesan“isappropriate”or“may”recommendationthatrepresentsgood(notquitebetter)clinicalpractice(i.e.,thereisgreatneedforfurtherresearch).Itisastrongsignaltoclinicalresearchersthatmoreworkneedstobedoneinevaluatinghowwelltheoreticalmodelsetc.translateintotheclinicalrealm.

• E–ExpertOpinionimpliesan“isappropriate”or“may”recommendationthatrepresentsgood(notquitebetter)clinicalpractice.Thismightbebasedprimarilyonreviewpapers,whitepapers,consensusdocumentsdevelopedbyvariousmethodology(e.g.,Delphi,RAND)andopinionoftheEBDworkgroup.Itcreatesanimperativeforclinicalresearcherstofillthemany“holes”thatwereidentifiedduringtheEBDdevelopment

• R-ResearchcanbeusedindividuallywhenthereisreallynoevidenceavailabletoguidepracticeorincombinationwithB-Egrades(whentheexistingevidenceneedsbolstering).Itgenerateseithera“mustdo”orshoulddo”aimedatclinicalresearchers,ratherthanclinicians.

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Grade Recommendations QualityofEvidence

A Strong ApreponderanceoflevelIstudies,butleast1levelIstudydirectlyonthetopicsupporttherecommendation.

B Moderate ApreponderanceoflevelIIstudiesbutatleast1levelIIstudydirectlyontopicsupporttherecommendation.

C Weak AsinglelevelIIstudyatlessthan25%criticalappraisalscoreorapreponderanceoflevelIIIandIVstudies,includingstatementsofconsensusbycontentexpertssupporttherecommendation.

D Theoretical/foundational

Apreponderanceofevidencefromanimalorcadaverstudies,fromconceptual/theoreticalmodels/principles,orfrombasicscience/benchresearchsupportsthisconclusion.

E

ExpertOpinion Bestpracticebasedonexpertopinion(reviewpapers,whitepapers,consensusdocumentsdevelopedbyvariousmethodology(e.g.,Delphi,RAND)andtheclinicalexperienceoftheguidelinedevelopmentgroup.

R Research Anabsenceofresearchonthetopic,orconclusionsfromexistingstudiesonthetopicareindisagreement.

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UseofBridge-WIZforWritingRecommendations

BRIDGE-Wizshouldbeusedforconstructingtherecommendationsandaccompanyingtextandshouldbeagroupactivity(in-personmeetingrecommended)toreducebias.IfWorkingGroupsdecidenottouseBridge-WIZ,theyshouldstillfollowtheformattinglistedbelow:

• Beginwithastatement(ActionStatement1).ActionstatementswillbelocatedonasummarypageatthebeginningoftheEBDandinthebodyofthetext.

• Followactionstatementwithelaboration–whoshoulddowhat,whenandwhere?• Followelaborationsentencewithlevelofevidenceandstrengthofrecommendation.• ExpandedrecommendationsarelocatedintheBodyoftheCPG

Repeattheactionstatementverbatimfromthesummarypage.

Elaborateusingthefollowingactionstatementprofile:

Aggregateevidencequality:Thisisonetotwosentencesofspecificevidencedetail(oddsratios,CIs)orsimplyanindicationoftheoveralllevelofevidencebasedonthedatafromtheevidencetables.

Benefits:Severalsentencesorbulletedremarksdescribingwhatisaccomplishedbyfollowingtheactionstatementand/orwhattheactionstatementoffersthepatient,family,therapistetc.

Risk,Harm,andCost:Listanyrisks,harms,orcostsassociatedwithfollowingtheactionstatement.

Benefit-HarmAssessment:Eachgroupshouldevaluatethisrelationshipandmakeastatement(inmanycases“Preponderanceofbenefit”).Userisk–benefitevidencewhereavailable.

ValueJudgments*:Identifyherewhentheworkinggroupincludesvaluestatements(usingGuidetoPTPractice,CodeofEthics,othervalue-relateddocuments)withinarecommendation.Identifyherewhentheworkinggroupadds,modifies,orotherwisechangesarecommendationbasedonvalueswhentheevidenceisunclearorisaclosecall.Forexample,thissectionmayexplainwhyalessreliablemeasuremaybeadvocatedoveranoverlyexpensive,time-consumingandcostlymeasurewithgreaterreliability.

Intentionalvagueness*:Elaborateonanactionstatementthatiswrittenwithintentionalvagueness.Forexample,examinationofabodystructure’simpairmentmaybestronglyrecommended.However,nospecificmeasurementtoolislisted.Thisisanexampleofknowingunambiguouslywhattodobuttheintentionalvaguenessexistsonhowtodoit.

Roleofpatient/caregiverpreferences*:Identifyif,when,orwherepreferencesand/orroleofcaregiverimpactsdecision-making.

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Exclusions*:Identifysituationsorcircumstanceswheretheactionstatementshouldnotbeapplied.Clearexceptionswillbeimportantwhenguidelinesareadaptedtomeasureclinicalperformance.

*WrittenafterBRIDGE-Wizgeneratesanactionstatement.

• ThisactionstatementprofileisthenfollowedbyaSupportingEvidenceandClinicalInterpretationsection.Thisincludes1-3paragraphssummarizingtheliteratureandprovidingnecessaryinformationoninterpretationofresults,elementsofarecommendedprocess,redflags,andresearchrecommendations/needs.ThissectionshouldbewrittenbyWorkingGroupmemberswithexpertiseinthetopicarea.

StepsFollowingWritingofRecommendations

Presentdraftrecommendationtorestofthegroupforconsensus

CompletedraftCPGandsubmittoAdvisoryCommitteeforreview.IncorporateACfeedback.

AssessCPGimplementability(seeImplementationSection).

SenddraftCPGtomultidisciplinaryexpertreviewgroup.Actonexternalreviewgroupfeedbackasappropriate.Keepatable/spreadsheetofexternalreviewgroupcommentsandhowtheGDGactedonthesecomments.

SubmittoNeurologySectionthroughtheAdvisoryCommitteetoinitiateacallforpublicreviewbyPTs,MDs,otherhealthprofessionals,patientadvocacygroups,patients/familyasappropriate(esp.ifCPG,orCGS,maynotbenecessaryforothertypesofEBD).

Juryandincorporatepubliccommentsintodocumentasappropriate

Submitdocumenttojournal/publisherforfurtherpeerreview,andrespondstocomments

SubmittoappropriatedatabasesforCPG(egNationalGuidelineClearinghouse).

PublicizepublicationofEBDthroughNeurologySection.

Planforrevisionprocess–seeRevisionPolicy.

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IX. RevisionofEvidence-BasedDocuments

Therevisionprocessisintegraltomaintainclear,updatedrecommendationsorguidelinesbasedonthemostcurrentevidence.TheDirectorofPractice(DoP)andtheAdvisoryCommittee(AC)shouldmaintainapolicyandprocedureformonitoring,reviewing,andupdatinganyEBD.EachEBDshouldbereviewed/revisedatleasteveryfiveyears(ie.someCPGportalspulltheCPGafterthe5yearpublicationdate).

IneachpublishedEBD,threedatesshouldbeclear:

• EBD/CPGpublicationdate• Dateofpertinentsystematicevidencereview• Proposeddateforreview/revisionofthedocumentand/orwhenthedocumentshouldbe

consideredinactiveifanupdateisnotperformed.Forexample,“Thisguidelinewillbeconsideredforreviewin(insertbasedonpresentpublicationdateplus5years),orsoonerifnewevidencebecomesavailable.AnyupdatestotheguidelineintheinterimperiodwillbenotedontheNeurologySectionoftheAPTAwebsite:http://www.neuropt.org/“

Therevisionprocessshouldbeginthreeyearsafterpublicationtoassurecompletionbythefiveyeardeadline.ThefollowingrecommendationswillsupportaseamlesstransitionofworkflowfromtheoriginalEBDworkgrouptotherevisionworkgroup:

• TheinitialEBDworkgroupisresponsibleforregularmonitoringoftheliteratureinordertoassessifnewandsignificantevidenceisavailable,andifupdatingtheEBDshouldoccurpriortoaformalfiveyearreview.Considerationsforrevisingthedocumentpriortothefiveyeartimeframeinclude:

o Newevidenceshowsthatarecommendedinterventioncausespreviouslyunknownsubstantialharm

o Anewexaminationorinterventionisfoundtobesignificantlysuperiortoapreviouslyrecommendedintervention

o Arecommendationcanbeappliedtonewpopulations• TheinitialEBDworkgroupisresponsibleformonitoringtheliteraturefornewandrelevant

publications(uptothreeyearspost-publicationoftheoriginalEBD).Thisincludescompletionofonefinalliteraturesearchtoupdatetheevidenceandcreateabibliographyfortherevisionsgroup.

• Tosupportcontinuity,theinitialEBDworkgroupshouldkeepcleardocumentationandnotes.Forexample,clearrecordsmayincludesearchtermsandstrategies,organizedevidencetables,etc.

• Bythethirdyear,theDoP,ACandLeaderoftheinitialEBDworkgroupidentifyany/allpersonsfromthatgroupthatwillcontinuetoworkontherevisionworkgroup.TheDoPandACconfirmleadershipfortherevisiongroup,andthisgroupmaybegintherevisionprocess.

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• Therevisionworkgroupshouldworkforafiveyearterm,ormaydefineamoreappropriatetimeframegiventheextentofnewevidencefound.

AsadditionalEBDworkgroupsareformed,orifthevolumeofEBDswarrantsthis,theDoPandACcanopttoaddanadditionalACmemberasRevisionsCoordinator.Thisshouldbeexaminedatleastannuallytomatchresourcesandneedsofnewly-developingorto-be-revisedEBDs.Alternatively,theDoPmayopttoassigntheRevisionsCoordinatorroletoanexistingACmember.Therolesandresponsibilitiesofthispersonwouldbeto:

• KeeptrackofallCPGs/EBDsandwhenrevisionsaredue.

• Contact,onbehalfoftheAC,theoriginalgrouptoidentifypotentialrevisionmembersandreporttotheAC.

• Facilitatehand-offbetweentheoriginalandrevisionCPG/EBDgroups.

TheACwillcontinuetoreviewandeditallsubmittedCPGsirrespectiveoftheirstatus(ie,original;revision).

X. ImplementationofEvidence-BasedRecommendations

OneofthefinalresponsibilitiesoftheEBDWorkgroupistoidentifythepotentialfacilitatorsandbarrierstoimplementingrecommendations.“Implementationreferstothatpartoftheguidelinelifecycleinwhichsystemsareintroducedtoinfluenceclinicians'behaviortowardguidelineadherence”.(GLIA,GuidelineImplementabilityAppraisalv2.0)

ThissectionfocusesspecificallyonCPGs,asonetypeofEBD,astheseinherentlyprovideasetofactionstatements.ForothertypesofEBDs,thatincluderecommendationsoractionstatements(iepositionstatement/whitepaper),itissuggestedthattheEBDworkgroup,atminimum,identifypotentialbarrierstoimplementationandconsiderpotentialstrategiestoenhanceimplementation.

Guidelinedevelopersshouldreflectonthefollowingareaswhenofferingrecommendationsforsupportingguidelineuptake:(modifiedTable3inShekelleetal,originallytakenfromGagliardietal)

• Useofmultipleformatsandchannelsforguidelinedisseminationbasedonpreferencesofthetargetgroupofhealthcarepractitioners.

• Developmentofeducationalresourcesadaptedincontent,andvehicletomeettheneedsofeachtargetgroupofhealthcarepractitioners(andotherstakeholders,asindicated).

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• Identificationoftheresourceimplicationsofrecommendations,ensuringtheiravailabilitybeforestarting.

• Useofdatacollectiontools(forexample,simpleaudittemplates).

ExamplesofstrategiesthatmaysupportimplementationofaCPGbytheindividual,clinicalprogram,department,orhealthsysteminclude:(KaplanSL,CoulterC,FettersL.Physicaltherapymanagementofcongenitalmusculartorticollis:anevidence-basedclinicalpracticeguideline.PediatricPhysicalTherapy.2013:348-394.)

• KeepacopyoftheCPGinalocationthatiseasytoreference.

• Compareitemsintherecommendedexamination/interventionlisttodeterminewhatshouldbeaddedtoanexaminationorplanofcaretoincreaseadherence.

• Adaptexaminationformstoincludeaplacetodocumenteachoftherecommendedmeasures.

• Adaptformatofdailynotestoincludeaplacetodocumentrecommendedinterventionsintheplanofcare.

• Seektrainingintheuseoftherecommendedstandardizedmeasuresand/orinterventionapproaches.

• BuildrelationshipswithotherhealthprovidersorreferralsourcestoencourageuseofCPG.

• Measureserviceoutcomesofcare(eg,patienteffectacrosstheICFdomains,costs,andcaregiversatisfaction).

Thesestrategiesshouldbeincludedwithinthe“implementation”sectionoftheCPGasawayofguidingindividuals,clinicalprograms,departmentsorhealthsystemsintoimplementingCPG.

AssessingtheImplementabilityofaCPG

TheimplementabilityofaCPGisdefinedas“theeaseandaccuracyoftranslationofguidelineadviceintosystemsthatinfluencecare”.(fromShiffmanRN,DixonJ,BrandtC,EssaihiA,HsiaoA,MichelG,O’ConnellR.TheGuideLineImplementability(GLIA):developmentofaninstrumenttoidentifyobstaclestoguidelineimplementation.BMCMedicalInformaticsandDecisionMaking.2005;5(23)).TheCPGdevelopmentworkgroupcanfacilitateimplementabilityoftheCPGthrough“pre-emptiveidentificationofpotentialbarriersofrecommendationsandwherepossiblesuggestpotentialsolutionstoaddress

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thembytheguidelineworkgroup.(fromGagliardietal.Howcanweimproveguidelineuse?Aconceptualframeworkofimplementability.ImplementationScience2011,6:26.)

Toaccomplishthis,thegroupshould:

1. Identifybarriersofcurrentpracticeattheprovider,payer,andpatientlevelsthatmayaffectimplementationofaguideline(education/training,requireddosage,paymentlimitations,technologicalresourceneeds)andprovidesuggestionsforimplementation.

a. Examples:structural(significantserviceredesignie.Redesignbusinessmodel),organization(lackoffacility,equipmentorstafforskillmix),individual(lackofknowledge,attitudeandskill)(WhohandbookonGuidelineDevelopment2010)

2. Elucidatenecessarycoordinationofcarewithotherpractitionersandalternativechoicesthatcouldbemadeandwouldrequirereferraltoanotherpractitioner(surgery,medication,etc)

OnetooltoassistinappraisingtheimplementabilityoftheCPGistheGLIA:theGuideLineImplementabilityAppraisalv.2.0.ThistoolshouldbeusedpriortoopeningtheCPGtoexpertpanelreview,publiccommentandpublication.Inthisstep,typically,anexternalpanelcomprisedofpeopleunfamiliarwiththeCPG’scontentanddevelopment,areinvitedtocompletetheGLIA.Eachactionstatementisappraisedacross8dimensionsofguidelineimplementability:

1. Executability(exactlywhattodo)

2. Decidability(preciselyunderwhatconditions(e.g.,age,gender,clinicalfindings,laboratory

results)todosomething)

3. Validity(thedegreetowhichtherecommendationreflectstheintentofthedeveloperandthe

strengthofevidence)

4. Flexibility(thedegreetowhicharecommendationpermitsinterpretationandallowsfor

alternativesinitsexecution)

5. Effectonprocessofcare(thedegreetowhichtherecommendationimpactsupontheusual

workflowinatypicalcaresetting)

6. Measurability(thedegreetowhichtheguidelineidentifiesmarkersorendpointstotrackthe

effectsofimplementationofthisrecommendation)

7. Novelty/innovation(thedegreetowhichtherecommendationproposesbehaviorsconsidered

unconventionalbycliniciansorpatients)

8. Computability(theeasewithwhicharecommendationcanbeoperationalizedinanelectronic

informationsystem)isonlyapplicablewhenanelectronicimplementationisplanned

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BasedontheGLIAresults,authorsofaCPGmaymodifyitscontentinorderimprovetheeaseinwhichrecommendationsmaybeappliedpriortopublicationorassistadministratorsinidentifyingpotentialproblemsinimplantingaCPGwithintheirorganizations.

AssessingwhetherapublishedCPGhasimpactonphysicaltherapypractice

Ultimately,adoptionandimplementationofCPGrecommendationsoccursthroughtheprocessofknowledgetranslation(Hudonetal).ItisbeyondthescopeoftheCPGworkgrouptoactuallyfacilitateandtomonitorthesuccessoftheknowledgetranslationprocess.BecausetheSectionisencouragingdevelopmentoftheCPGtoenhancephysicaltherapypractice,itmayfalltotheSectiontoundertakeassessmentofbarrierstoimplementationattheleveloftheSection,andtodevelopandimplementstrategiestofacilitateadoptionoftheCPGithassponsored.DevelopmentofaCPGrequiresarigorousinquiryandsynthesisprocessthatresultsin“creation”ofnewknowledge.TheSectiondisseminatesthisnewknowledgeviapublicationinitsjournal,makingitavailableonitswebsite,andpresentationsatCombinedSectionsMeetings.DisseminationalonedoesnotguaranteethattheCPGwillbeadoptedatthehealthcareadministrativeandclinicalpracticelevel.IftheSectionintendsnewlydevelopedCPGstochangeandimprovethepracticeofneurologicalphysicaltherapy,thenitshoulddevelopstrategiestofacilitatetheknowledgetranslationprocess,andtomonitortheimpactofCPGsindailyclinicalpractice.Figure1presentsapotentialmodel,attheleveloftheSection,tofacilitatetheknowledgetranslationprocess,suchthatCPGssupportedanddisseminatedbytheSectionare“living”andeffectivedocuments.(Friedmanetal).

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Figure1:ConceptualModelfortheknowledgetoactionprocessforimplementationofCPGsinNeurologicalPhysicalTherapyPractice(adaptedfromGrahamID,LoganJ,HarrisonMBetal.Lostinknowledgetranslation:timeforamap?JContinEducHealthProf,2006:26:13-24.)

NewKnowledge:

CPG

(FollowingDissemination)

ID&SELECTPROBLEM

PrioritizebarrierstoCPGimplementationforSoNto

address ADAPTKNOWLEDGE

DetermineSoNMemberneedsforCPGadoption

ADDRESSBARRIERS

Develop“interventions”tofacilitateCPGadoptionthatmeetmemberneeds

IMPLEMENT

DeliverinterventionsdesignedtofacilitateCPG

adoption

MONITOREFFECT

Develop&implementstrategiestosupport

membereffortsforKTpostintervention

EVALUATEOUTCOME

Develop&implementstrategiestodetermineif/howwellCPGhasbeen

adopted

SUSTAINKNOWLEDGEUSE

Recognize/celebratesuccessfuladoption(asmodelforother

settings)

MONITORADOPTION

Develop&implementstrategiestoassesslevelofCPGadoptionbymembersandtheirinstitutions

ONGOINGEVALUATION

Identifynewbarriersand/oradditional

memberneedsreCPG

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AlthoughtheadoptionofaCPGasa“living”documentcanbeconsideredcyclicalinnature,theSoNcanentertheprocessbyidentifyingwhichofthebarrierstoCPGimplementationidentifiedinthenewCPGcanbebestaddressedattheleveloftheSection.Suchbarriersmightincludealackofknowledgeabout“howto”read/interpretthedocumentamongSoNmembers,lackofunderstandingonthepartofrehabilitationmanagersaboutincorporatingrecommendationsintodailyoperations,ordifficultyinchangingdocumentationsystemstoeffectivelycomplywithrecommendations. Oncesuchbarriersandmemberneedshavebeenidentifiedandprioritized,theSoNwouldbegintoconsiderhowbesttoaddresstheproblem/s.TheSoNmightchoosetoassembleagroupofindividualswithexpertiseinknowledgetranslationormembersoftheEBDAdvisoryBoardtodevelopaseriesof“interventions”toassistmembersintheprocessofadoptingtheCPGintoclinicalpractice.Thismightinclude(asexamples)a)a“howtoread/interpret/applyCPGsasapresentationatmultipleCSMs;b)regionalworkshopsaimedatclinicalmanagersonassessmentofwheretheirpracticesetting“sits”withregardtotheexaminations/evaluations,interventions,andoutcomemeasurementstrategiesrecommendedintheCPG,withanemphasisonhelpingmanagersidentifybarriers/challengesandpotentialsolutionsattheirspecificinstitution;orc)consultationserviceswhereexpertSoNmembers“visit“anorganizationinterestedinadoptingtheCPG.Therearelikelymanyadditionalcreative“interventions”thatcouldbedevelopedtomeetmemberneeds(Friedmanetal).

InordertomonitortheeffectandevaluatetheoutcomesofadoptionofanewCPG,itmaybehelpfulfortheSoNtocreateanetworkofindividuals/agenciesworkingtoimplementtheCPGattheirownsetting.KeepingintouchwithpersonswhohaveattendedSectionsponsored“interventions”wouldprovidepeersupportandnetworkingopportunities,aswellasawaytocollectinformationaboutfacilitators/barrierstochangeacrosssettings(Dulko).SuchpooledinformationwouldassistfutureCPGdevelopmentgroupstobetterunderstandtheprocessofknowledgetranslationandbuildstrategiesforchangeintotheirdocuments,aswellasassisttheCPGrevisionworkgroupbetterunderstandwhatmightneedtobeupdated/changedastheyapproachtherevisionprocess.

TokeepaCPG“alive”overthe5-year-to-revisionpublicationlifetime(i.e.,sustainit’suseintheclinic)theSoNmightchoosetorecognize/celebratesuccessfuladoption(includingbutnotlimitedtothesteps/strategiesusedtoincorporatetheCPGintopractice,changesindocumentation,consequencesintermsofefficiencyandefficacyofcare,andoutcomesintermsofreimbursement)byhighlightingpractices/agenciesthathavemadethetransition.Thismighttaketheformofarticlesinthee-newsletter,presentationsatCSM,orascholarlyarticleinJNPT.SucheffortswouldpotentiallyprovideincentiveaswellasasuccessfulmodelforotherpracticesettingsconsideringadoptionofthenewCPG.OneofthemajorchallengesfacedbygroupswhodevelopanddisseminateCPGsistoreallyunderstandiftheirworkhaseffectivelyimprovedpractice(Countsetal;Brusamentoetal).Bysettingupthe“infrastructure”describedabove,theSoNcreatesforitselfanopportunityto“study”theclinicalimpactofaCPG.Forexample,ayearlysurveysenttothosewhoparticipatedinSoNsponsoredinterventionsaswellastoarandomsampleofmembers(sortedbysettingtowhichtheCPGapplies)wouldprovidedescriptivedataabouttheimpactoftheCPGonpractice.Suchaneffortwouldalsoserveasavehicleforongoingevaluationofmemberneedswithrespecttounderstanding,embracing,andimplementingtheCPG.

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AdditionalReferences

BrusamentoS,Legido-QuigleyH,PanteliD,etal.AssessingtheeffectivenessofstrategiestoimplementclinicalguidelinesforthemanagementofchronicdiseasesatprimarycarelevelinEUMemberStates:asystematicreview.HealthPolicy.2012Oct;107(2-3):168-183.

CountsJM,AstlesJR,LipmanHB.Assessingphysicianutilizationoflaboratorypracticeguidelines:barriersandopportunitiesforimprovement.ClinBiochem.2013;46(15):1554-60.

DulkoD.Auditandfeedbackasaclinicalpracticeguidelineimplementationstrategy:amodelforacutecarenursepractitioners.WorldviewsEvidBasedNurs.2007;4(4):200-209.

FriedmanL,EngelkingC,WickhamR,HarveyC,ReadM,WhitlockKB.TheEDUCATEStudy:acontinuingeducationexemplarforClinicalPracticeGuidelineImplementation.ClinJOncolNurs.2009;13(2):219-230.doi:10.1188/09.CJON.219-230.

HudonA.GervaisMJ,HuntM.Thecontributionofconceptualframeworkstoknowledgetranslationinphysicaltherapy.PhysTher.2014epubaheadofprinthttp://ptjournal.apta.org/content/early/2014/07/23/ptj.20130483

ShiffmanNR,DixonJ,BrandtC,etal.TheGuideLineImplementabilityAppraisal(GLIA):developmentofaninstrumenttoidentifyobstaclestoguidelineimplementation.BMCMedicalInformatics&DecisionMaking.2005;5(1):23-28.