The Australian ‘FORM’ approach to guideline development: The quest for the perfect system

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The Australian ‘FORM’ approach to guideline development: The quest for the perfect system
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Background: Clinical practice guidelines have been defined as systematically developed statements to assist practitioner and patient decision-making about appropriate health care for specific clinical circumstances. They play an important role in guiding evidence based clinical practice. The Australian National Health and Medical Research Council has developed and pilot-tested a new framework for guideline development, the FORM approach, the role of which has yet to be further defined. Methods: We critically review the elements of the FORM approach and compare it to other, more established methods for rating the quality of evidence and strength of recommendations. Results: FORM recognizes five factors that impact the strength of a recommendation which are the evidence base, consistency, clinical impact, generalizability and applicability. Consideration of these elements leads to a four-tiered rating system represented by the letters A ("body of evidence can be trusted to guide practice”) to D ("body of evidence is weak and recommendation must be applied with caution”). It builds on other existing guideline methodologies such as those developed by the Scottish Intercollegiate Guidelines Network (SIGN), the Strength of Recommendation Taxonomy (SORT) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) groups. FORM distinguishes itself from other systems by its strong emphasis on applicability, which is separated out as its own category and relates the relevance of the body of evidence to the Australian healthcare system. Conclusions: The FORM approach offers a methodologically rigorous alternative approach to guideline development that places particular emphasis on aspects of applicability. This feature is unique and may prompt future adoption by other guidelines systems
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Dahm and Djulbegovic BMC Medical Research Methodology 2011, 11:17 http://www.biomedcentral.com/1471-2288/11/17; Pages 1-3
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COMMENTARY OpenAccessTheAustralian FORM approachtoguideline development:ThequestfortheperfectsystemPhilippDahm1,BenjaminDjulbegovic2*AbstractBackground: Clinicalpracticeguidelineshavebeendefinedassystematicallydevelopedstatementstoassist practitionerandpatientdecision-makingaboutappropriatehealthcareforspecificclinicalcircumstances.Theyplay animportantroleinguidingevidencebasedclinicalpractice.TheAustralianNationalHealthandMedicalResearch Councilhasdevelopedandpilot-testedanewframeworkforguidelinedevelopment,theFORMapproach,therole ofwhichhasyettobefurtherdefined. Methods: WecriticallyreviewtheelementsoftheFORMapproachandcompareittoother,moreestablished methodsforratingthequalityofevidenceandstrengthofrecommendations. Results: FORMrecognizesfivefactorsthatimpactthestrengthofarecommendationwhicharetheevidencebase, consistency,clinicalimpact,generalizabilityandapplicability.Considerationoftheseelementsleadstoafour-tiered ratingsystemrepresentedbythelettersA("bodyofevidencecanbetrustedtoguidepractice )toD("bodyof evidenceisweakandrecommendationmustbeappliedwithcaution ).Itbuildsonotherexistingguideline methodologiessuchasthosedevelopedbytheScottishIntercollegiateGuidelinesNetwork(SIGN),theStrengthof RecommendationTaxonomy(SORT)andtheGradingofRecommendationsAssessment,Developmentand Evaluation(GRADE)groups.FORMdistinguishesitselffromothersystemsbyitsstrongemphasisonapplicability, whichisseparatedoutasitsowncategoryandrelatestherelevanceofthebodyofevidencetotheAustralian healthcaresystem. Conclusions: TheFORMapproachoffersamethodologicallyrigorousalternativeapproachtoguideline developmentthatplacesparticularemphasisonaspectsofapplicability.Thisfeatureisuniqueandmayprompt futureadoptionbyotherguidelinessystemsCommentaryClinicalpracticeguidelineshavebeendefinedassystematicallydevelopedstatementstoassistpractitionerand patientdecision-makinga boutappropriatehealthcare forspecificclinicalcircum stances[1].Alongsidewith effortstosystematicallydrawtogethertheentirebody ofevidenceforaspecificclinicalquestionaspromoted bytheCochraneCollaboration[2]andtheevidencebasedmedicinemovementwithitsemphasisoncritical appraisal[3],theguidelinemovementhasbeenoneof thedrivingforcestowardsamoreevidence-basedpracticeofmedicine.Clinicalpracticeguidelinesalsoholda prominentpositioninthehierarchyofevidence-based resources,astheylinkevidencewithdecision-making foragivenclinicalconditionatthepointofcare[4]. Sincetheirhumblebeginningsintheearlynineties,the definingcharacteristicsofclinicalpracticeguidelinesthat canrightfullyconsiderthemselves evidence-based have increasinglybeendeveloped[5].Theseincludeaformal ratingofthequalityoftheevidencethatgoesbeyond studydesignaloneandconsi derstowhatextentmethodologicalsafeguardsagainstbias(suchasallocationconcealment,blinding,drop-outratesetc)areputinplaceto minimizetheriskofbias.Earlyon,therewaslittleconsensusonhowtoratethequalityofevidence,andby 2002therewere106competingevidentiarysystemsavailable[6].However,basingevidentiaryrulesonstudy designaloneyieldedunsatisfactoryresultswhenitcame toguidingtheactionforclinicaldecision-makers,thereby *Correspondence:bdjulbeg@health.usf.edu2DivisionandCenterforEvidence-BasedMedicineandHealthOutcomes Research,UniversityofSouthFlorida&H.LeeMoffittCancerCenter& ResearchInstitute,Tampa,FL,USA FulllistofauthorinformationisavailableattheendofthearticleDahmandDjulbegovic BMCMedicalResearchMethodology 2011, 11 :17 http://www.biomedcentral.com/1471-2288/11/17 2011DahmandDjulbegovic;licenseeBioMedCentralLtd.ThisisanOpenAccessarticledistributedunderthetermsoftheCreative CommonsAttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,and reproductioninanymedium,providedtheoriginalworkisproperlycited.

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promotingthedevelopmento fanewgenerationofsystemstodevelopclinicalpracticeguidelines[7].Thisgenerationofmethodologicalframeworksisrepresentedby thosecurrentlyusedbytheU.S.PreventiveServices TaskForce(USPSTF),theNationalInstituteforHealth andClinicalExcellence(NICE),theScottishIntercollegiateGuidelinesNetwork(SIGN),theStrengthofRecommendationTaxonomy(SORT)andtheGradingof RecommendationsAssessment,DevelopmentandEvaluation(GRADE)groups.Amajorcontributionofthese systemshasbeentherecognitionthatfactorsotherthan thequalityofevidencealoneimpactclinicalrecommendations,therebypromptingaclearseparationofthequalityofevidencefromthestrengthofarecommendation. TheFORMframeworkrepresentsanewarrivalofanevidence-basedmethodologytodevelopclinicalpractice guidelines[8].ItclearlyacknowledgesitsrootsintheSIGN andSORTsystems,whichwereadaptedtomeettheperceivedneedsofstakeholderorganizationrepresentativesin theAustralianhealthcaresystem.Inbrief,itrecognizesfive factorsthatimpactthestrengthofarecommendation whicharetheevidencebase,consistency,clinicalimpact, generalizabilityandapplicability.Considerationofthese elementsthenleadstoafour-tieredratingsystemrepresentedbythelettersA("bodyofevidencecanbetrustedto guidepractice )toD("bodyofevidenceisweakand recommendationmustbeappliedwithcaution ). Althoughthissystemisnove l,itshouldberecognized thatitdifferslittlefromtheexistingguidelinessystems. Forexample,whencomparingFORMwithGRADE, whichisusedbymorethan55organizationsin23countries, clinicalimpact referstothelikelybenefitthat applicationoftheguidelinecanrealizewhilealsotaking intoaccounttherelevanceoftheeffecttopatients(clinicalimportance),precision andeffectsize[9].GRADE considersalloftheseelementsinoperationallydifferent ways-itstartswiththeclinicalimportanceoftheoutcomes,takesintoaccountthemagnitudeoftheeffect anditsprecisionaspartoftheevaluationofqualityof evidenceandassessestheratioofbenefittoharm(which GRADEconsidersoneofthreeotherdimensionsdistinct fromthequalityofevidence)informulationoftheguidelinerecommendations[10].However,whatdistinguishes FORMfromothersystemsisitsstrongemphasison applicability,whichissepa ratedoutasitsowncategory andrelatestherelevanceofthebodyofevidencetothe Australianhealthcaresystem.Thisfeatureisuniqueand maypromptfutureadoptionbyotherguidelinessystems. Inanidealworld,guidelinesdeveloperswouldemploy aunifiedsystemtoratethequalityofevidenceand strengthsofrecommendations[11].Doingsowoulddispelthe Babylonianconfusion amonguserstryingto makesenseofthevaryingterminologyanddefinitions usedbyvariousguidelinesdevelopers,ultimatelyhelping toenhanceguidelinesimplementation[12].Todate,no suchunifiedsystemexistsandweareconfrontedwitha fairlylargenumberofcompetingsystemsthatfailto readilytranslateoneintoanother[13]. Howshouldwearriveatthe best system?Todoso, onewouldultimatelyliketoshowthata)thesystem resultsinmakingrecommendationsthatwillleadtobetteroutcomesthanrecommendationsbyothersystems andb)thesystemismorereproduciblethanothers.The firstpointwillbedifficulttoproveempiricallyandmay thereforeremainforeverunresolved.Thesecondpoint relatestotheissueofwhetherasystemsuchasFORM canbeoperationalizedintermsofpractical,reproducible policyandprocedures.Toillu stratethechallenge,considerthenumberofcombinationsthatcanarisefromthe FORMsystemthat(asshownintable1inthemanuscript)distinguishesbetweenfivefactorsthatcanbe ratedinfourdifferentwaystherebyresultingin45= 1024combinations.Thesemustbeconsideredinconjunctionwithrecommendationsthataremadeusinga four-tieredscalefororagainstanintervention(42=16 combinations).Thisresultsinamind-boggling16,384 (102416)waysinwhichabodyofevidencecantheoreticallybecategorizedtosupportclinicalrecommendations.Itis,however,highlylikelythatsomecombinations aremoreprevalentthanothersmakingdevelopmentof theguidelinessystemmorefeasiblethanthesetheoretical calculationsappeartoindicate.Nevertheless,itisalso likelythatthiscomplexity,hithertoonlyimplicitly acknowledgedbythepeopleinthefield,drivestheefforts todevelopnewsystemsforguidelinesdevelopment.Itis alsoclearthataswestrivetodevelopaunifiedguidelines system,wemustfindawaytorateabodyofevidence andstrengthofrecommendationsinareproducibleand reliablemanner.Webelievethatthemostimportant nextstepintheEBMfieldrelatestotheneedtoperform empiricalmethodologicalresearchtoevaluatewhichof theexistingguidelinessystemsismostreproducibleand performsbestinthehandsoftheindividualstheyare meanttoserve.Withoutundertakingthisresearch,the entireevidence-basedmedicineedificemayloseitssolid ground,builtsocarefullyoverthelast20years.Authordetails1DepartmentofUrologyandProstateDiseaseCenter,UniversityofFlorida, CollegeofMedicine,Gainesville,FL,USA.2DivisionandCenterforEvidenceBasedMedicineandHealthOutcomesResearch,UniversityofSouthFlorida &H.LeeMoffittCancerCenter&ResearchInstitute,Tampa,FL,USA. Received:14December2010Accepted:15February2011 Published:15February2011 References1.ShaneyfeltTM,Mayo-SmithMF,RothwanglJ: Areguidelinesfollowing guidelines?Themethodologicalqualityofclinicalpracticeguidelinesin thepeer-reviewedmedicalliterature. JAMA 1999, 281(20) :1900-1905.DahmandDjulbegovic BMCMedicalResearchMethodology 2011, 11 :17 http://www.biomedcentral.com/1471-2288/11/17 Page2of3

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2.StarrM,ChalmersI,ClarkeM,OxmanAD: Theorigins,evolution,and futureofTheCochraneDatabaseofSystematicReviews. IntJTechnol AssessHealthCare 2009, 25(Suppl1):182-195. 3.SackettDL,RosenbergWM,GrayJA,HaynesRB,RichardsonWS: Evidence basedmedicine:whatitisandwhatitisn t. BMJ 1996, 312(7023) :71-72. 4.HaynesRB: Ofstudies,syntheses,synopses,summaries,andsystems:the 5S evolutionofinformationservicesforevidence-basedhealthcare decisions. ACPJClub 2006, 145(3) :A8. 5.SibbaldB,BrouwersMC,KhoME,BrowmanGP,BurgersJS,CluzeauF, FederG,FerversB,GrahamID,GrimshawJ,HannaSE,LittlejohnsP, MakarskiJ,ZitzelsbergerL: AGREEII:Advancingguidelinedevelopment, reportingandevaluationinhealthcare. JClinEpidemiol 6.WestS,KingV,CareyTS,LohrKN,McKoyN,SuttonSF,LuxL: Systemsto ratethestrengthofscientificevidence. EvidRepTechnolAssess(Summ) 2002,, 47: 1-11. 7.AtkinsD,EcclesM,FlottorpS,GuyattGH,HenryD,HillS,LiberatiA, O ConnellD,OxmanAD,PhillipsB,SchunemannH,EdejerTT,VistGE, WilliamsJWJr,TheGRADEWorkingGroup: Systemsforgradingthe qualityofevidenceandthestrengthofrecommendationsI:critical appraisalofexistingapproachesTheGRADEWorkingGroup. BMCHealth ServRes 2004, 4(1) :38. 8.HillierS,Grimmer-SomersK,MerlinT,MiddletonP,SalisburyJ,TooherR, WestonA: FORM:AnAustralianmethodforformulatingandgrading recommendationsinevidence-basedclinicalguidelines. BMCMedRes Methodol 9.GuyattGH,OxmanAD,KunzR,VistGE,Falck-YtterY,SchunemannHJ,for theGRADEWorkingGroup: Whatis qualityofevidence andwhyisit importanttoclinicians? BMJ 2008, 336(7651) :995-998. 10.GuyattGH,OxmanAD,KunzR,Falck-YtterY,VistGE,LiberatiA, SchunemannHJ,fortheGRADEWorkingGroup: Goingfromevidenceto recommendations. BMJ 2008, 336(7652) :1049-1051. 11.GuyattG,VistG,Falck-YtterY,KunzR,MagriniN,SchunemannH: An emergingconsensusongradingrecommendations? ACPJClub 2006, 144(1) :A8-A9. 12.GugiuPC,GugiuMR: Acriticalappraisalofstandardguidelinesfor gradinglevelsofevidence. EvalHealthProf 2010, 33(3) :233-255. 13.EddyDM: Evidence-basedmedicine:aunifiedapproach. HealthAff (Millwood) 2005, 24(1) :9-17.Pre-publicationhistory Thepre-publicationhistoryforthispapercanbeaccessedhere: http://www.biomedcentral.com/1471-2288/11/17/prepubdoi:10.1186/1471-2288-11-17 Citethisarticleas: DahmandDjulbegovic: TheAustralian FORM approachtoguidelinedevelopment:Thequestfortheperfectsystem. BMCMedicalResearchMethodology 2011 11 :17. Submit your next manuscript to BioMed Central and take full advantage of: Convenient online submission Thorough peer review No space constraints or color gure charges Immediate publication on acceptance Inclusion in PubMed, CAS, Scopus and Google Scholar Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit DahmandDjulbegovic BMCMedicalResearchMethodology 2011, 11 :17 http://www.biomedcentral.com/1471-2288/11/17 Page3of3


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ca yes A2 DjulbegovicBenjaminI2 bdjulbeg@health.usf.edu
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ins Department of Urology and Prostate Disease Center, University of Florida, College of Medicine, Gainesville, FL, USA
Division and Center for Evidence-Based Medicine and Health Outcomes Research, University of South Florida & H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA
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cpyrt 2011collab Dahm and Djulbegovic; licensee BioMed Central Ltd.note This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Abstract
Background
Clinical practice guidelines have been defined as systematically developed statements to assist practitioner and patient decision-making about appropriate health care for specific clinical circumstances. They play an important role in guiding evidence based clinical practice. The Australian National Health and Medical Research Council has developed and pilot-tested a new framework for guideline development, the FORM approach, the role of which has yet to be further defined.
Methods
We critically review the elements of the FORM approach and compare it to other, more established methods for rating the quality of evidence and strength of recommendations.
Results
FORM recognizes five factors that impact the strength of a recommendation which are the evidence base, consistency, clinical impact, generalizability and applicability. Consideration of these elements leads to a four-tiered rating system represented by the letters A ("body of evidence can be trusted to guide practice") to D ("body of evidence is weak and recommendation must be applied with caution"). It builds on other existing guideline methodologies such as those developed by the Scottish Intercollegiate Guidelines Network (SIGN), the Strength of Recommendation Taxonomy (SORT) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) groups. FORM distinguishes itself from other systems by its strong emphasis on applicability, which is separated out as its own category and relates the relevance of the body of evidence to the Australian healthcare system.
Conclusions
The FORM approach offers a methodologically rigorous alternative approach to guideline development that places particular emphasis on aspects of applicability. This feature is unique and may prompt future adoption by other guidelines systems
bdy
Commentary
Clinical practice guidelines have been defined as systematically developed statements to assist practitioner and patient decision-making about appropriate health care for specific clinical circumstancesabbrgrp
abbr bid B1 1
. Alongside with efforts to systematically draw together the entire body of evidence for a specific clinical question as promoted by the Cochrane Collaboration
B2 2
and the evidence-based medicine movement with its emphasis on critical appraisal
B3 3
, the guideline movement has been one of the driving forces towards a more evidence-based practice of medicine. Clinical practice guidelines also hold a prominent position in the hierarchy of evidence-based resources, as they link evidence with decision-making for a given clinical condition at the point of care
B4 4
.
Since their humble beginnings in the early nineties, the defining characteristics of clinical practice guidelines that can rightfully consider themselves "evidence-based" have increasingly been developed
B5 5
. These include a formal rating of the quality of the evidence that goes beyond study design alone and considers to what extent methodological safeguards against bias (such as allocation concealment, blinding, drop-out rates etc) are put in place to minimize the risk of bias. Early on, there was little consensus on how to rate the quality of evidence, and by 2002 there were 106 competing evidentiary systems available
B6 6
. However, basing evidentiary rules on study design alone yielded unsatisfactory results when it came to guiding the action for clinical decision-makers, thereby promoting the development of a new generation of systems to develop clinical practice guidelines
B7 7
. This generation of methodological frameworks is represented by those currently used by the U. S. Preventive Services Task Force (USPSTF), the National Institute for Health and Clinical Excellence (NICE), the Scottish Intercollegiate Guidelines Network (SIGN), the Strength of Recommendation Taxonomy (SORT) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) groups. A major contribution of these systems has been the recognition that factors other than the quality of evidence alone impact clinical recommendations, thereby prompting a clear separation of the quality of evidence from the strength of a recommendation.
The FORM framework represents a new arrival of an evidence-based methodology to develop clinical practice guidelines
B8 8
. It clearly acknowledges its roots in the SIGN and SORT systems, which were adapted to meet the perceived needs of stakeholder organization representatives in the Australian healthcare system. In brief, it recognizes five factors that impact the strength of a recommendation which are the evidence base, consistency, clinical impact, generalizability and applicability. Consideration of these elements then leads to a four-tiered rating system represented by the letters A ("body of evidence can be trusted to guide practice") to D ("body of evidence is weak and recommendation must be applied with caution").
Although this system is novel, it should be recognized that it differs little from the existing guidelines systems. For example, when comparing FORM with GRADE, which is used by more than 55 organizations in 23 countries, "clinical impact" refers to the likely benefit that application of the guideline can realize while also taking into account the relevance of the effect to patients (clinical importance), precision and effect size
B9 9
. GRADE considers all of these elements in operationally different ways- it starts with the clinical importance of the outcomes, takes into account the magnitude of the effect and its precision as part of the evaluation of quality of evidence and assesses the ratio of benefit to harm (which GRADE considers one of three other dimensions distinct from the quality of evidence) in formulation of the guideline recommendations
B10 10
. However, what distinguishes FORM from other systems is its strong emphasis on applicability, which is separated out as its own category and relates the relevance of the body of evidence to the Australian healthcare system. This feature is unique and may prompt future adoption by other guidelines systems.
In an ideal world, guidelines developers would employ a unified system to rate the quality of evidence and strengths of recommendations
B11 11
. Doing so would dispel the "Babylonian confusion" among users trying to make sense of the varying terminology and definitions used by various guidelines developers, ultimately helping to enhance guidelines implementation
B12 12
. To date, no such unified system exists and we are confronted with a fairly large number of competing systems that fail to readily translate one into another
B13 13
.
How should we arrive at the "best" system? To do so, one would ultimately like to show that a) the system results in making recommendations that will lead to better outcomes than recommendations by other systems and b) the system is more reproducible than others. The first point will be difficult to prove empirically and may therefore remain forever unresolved. The second point relates to the issue of whether a system such as FORM can be operationalized in terms of practical, reproducible policy and procedures. To illustrate the challenge, consider the number of combinations that can arise from the FORM system that (as shown in table 1 in the manuscript) distinguishes between five factors that can be rated in four different ways thereby resulting in 4sup 5 = 1024 combinations. These must be considered in conjunction with recommendations that are made using a four-tiered scale for or against an intervention (42 = 16 combinations). This results in a mind-boggling 16,384 (1024 × 16) ways in which a body of evidence can theoretically be categorized to support clinical recommendations. It is, however, highly likely that some combinations are more prevalent than others making development of the guidelines system more feasible than these theoretical calculations appear to indicate. Nevertheless, it is also likely that this complexity, hitherto only implicitly acknowledged by the people in the field, drives the efforts to develop new systems for guidelines development. It is also clear that as we strive to develop a unified guidelines system, we must find a way to rate a body of evidence and strength of recommendations in a reproducible and reliable manner. We believe that the most important next step in the EBM field relates to the need to perform empirical methodological research to evaluate which of the existing guidelines systems is most reproducible and performs best in the hands of the individuals they are meant to serve. Without undertaking this research, the entire evidence-based medicine edifice may lose its solid ground, built so carefully over the last 20 years.
bm
refgrp Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literatureShaneyfeltTMMayo-SmithMFRothwanglJJAMA1999281201900lpage 190510.1001/jama.281.20.1900link fulltext 10349893The origins, evolution, and future of The Cochrane Database of Systematic ReviewsStarrMChalmersIClarkeMOxmanADInt J Technol Assess Health Care200925Suppl 118219510.1017/S026646230909062X19534840Evidence based medicine: what it is and what it isn'tSackettDLRosenbergWMGrayJAHaynesRBRichardsonWSBMJ199631270237172pmcid 23497788555924Of studies, syntheses, synopses, summaries, and systems: the "5S" evolution of information services for evidence-based health care decisionsHaynesRBACP J Club20061453A817080967AGREE II: Advancing guideline development, reporting and evaluation in health careSibbaldBBrouwersMCKhoMEBrowmanGPBurgersJSCluzeauFFederGFerversBGrahamIDGrimshawJHannaSELittlejohnsPMakarskiJZitzelsbergerLJ Clin Epidemiolinpress Systems to rate the strength of scientific evidenceWestSKingVCareyTSLohrKNMcKoyNSuttonSFLuxLEvid Rep Technol Assess (Summ)20024711111979732Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working GroupAtkinsDEcclesMFlottorpSGuyattGHHenryDHillSLiberatiAO'ConnellDOxmanADPhillipsBSchunemannHEdejerTTVistGEWilliamsJWsuf Jrcnm The GRADE Working GroupBMC Health Serv Res2004413810.1186/1472-6963-4-3854564715615589FORM: An Australian method for formulating and grading recommendations in evidence-based clinical guidelinesHillierSGrimmer-SomersKMerlinTMiddletonPSalisburyJTooherRWestonABMC Med Res MethodolWhat is "quality of evidence" and why is it important to clinicians?GuyattGHOxmanADKunzRVistGEFalck-YtterYSchunemannHJfor the GRADE Working GroupBMJ2008336765199599810.1136/bmj.39490.551019.BE18456631Going from evidence to recommendationsGuyattGHOxmanADKunzRFalck-YtterYVistGELiberatiASchunemannHJfor the GRADE Working GroupBMJ200833676521049105110.1136/bmj.39493.646875.AE18467413An emerging consensus on grading recommendations?GuyattGVistGFalck-YtterYKunzRMagriniNSchunemannHACP J Club20061441A8A916388549A critical appraisal of standard guidelines for grading levels of evidenceGugiuPCGugiuMREval Health Prof201033323325510.1177/016327871037398020801972Evidence-based medicine: a unified approachEddyDMHealth Aff (Millwood)200524191710.1377/hlthaff.24.1.915647211
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Abstract
Background
Clinical practice guidelines have been defined as systematically developed statements to assist practitioner and patient decision-making about appropriate health care for specific clinical circumstances. They play an important role in guiding evidence based clinical practice. The Australian National Health and Medical Research Council has developed and pilot-tested a new framework for guideline development, the FORM approach, the role of which has yet to be further defined.
Methods
We critically review the elements of the FORM approach and compare it to other, more established methods for rating the quality of evidence and strength of recommendations.
Results
FORM recognizes five factors that impact the strength of a recommendation which are the evidence base, consistency, clinical impact, generalizability and applicability. Consideration of these elements leads to a four-tiered rating system represented by the letters A ("body of evidence can be trusted to guide practice") to D ("body of evidence is weak and recommendation must be applied with caution"). It builds on other existing guideline methodologies such as those developed by the Scottish Intercollegiate Guidelines Network (SIGN), the Strength of Recommendation Taxonomy (SORT) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) groups. FORM distinguishes itself from other systems by its strong emphasis on applicability, which is separated out as its own category and relates the relevance of the body of evidence to the Australian healthcare system.
Conclusions
The FORM approach offers a methodologically rigorous alternative approach to guideline development that places particular emphasis on aspects of applicability. This feature is unique and may prompt future adoption by other guidelines systems
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1471-2288-11-17.pdf
structMap sword-mets-struct-1 structure LOGICAL
div sword-mets-div-1 DMDID Object
sword-mets-div-2 File
fptr FILEID
sword-mets-div-3