JCE 2004 brPage 4br Intervention Multiple components Care providers Centre Standardization Specific training Quality control procedures Fidelity Gap between the intended administered intervention An extension for nonpharmacologic treatments Why ID: 70824
Download Pdf The PPT/PDF document "EQUATOR Network seminar Isabelle Boutron..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1 EQUATORNetworkseminar IsabelleBoutron CenterofClinicalEpidemiology FrenchCochranecenter HôtelDieuHospital CONSORTextension CONSORTforNon-pharmacologic interventions Anextensionfornon-pharmacologictreatments Why? -surgery -technicaloperation (arthroscopy,…) -rehabilitation -education -orthopedicbraces ororthosis -lasertreatment Participative interventions Nonimplantabledevices Therapist-dependent interventions Non-pharmacologictreatments(NPT)concernalargevariety oftreatments 3 Anextensionfornon-pharmacologictreatments Why? •Placebo –Placeboofsurgery? –Placeboofpsychotherapy? •Blinding –Feasibilityofblinding –Successofblinding BoutronIetal.JCE2004 4 Intervention Multiplecomponents Careproviders Centre Standardization -Specific training -Quality control procedures Fidelity Gapbetweenthe -intended -administered intervention Anextensionfornon-pharmacologictreatments Why? -Procedure -Drug -Anesthesia -Education -Rehabilitation -etc. Halmetal,AnnInternMed2002 5 Copyright©2008BMJPublishingGroupLtd. GlasziouPetal.BMJ2008 Percentageofstudieswithsufficientdescriptionofinitialtreatment(basedonlyonthe publishedpaper)andaftersupplementaryinformationwasobtainedfromauthors. 6 Anextensionfornon-pharmacologictreatments Why? Studyofsurgicalpapers(n=158)publishedin2004 •Reportingofdetailsoftheintendedintervention –Surgicalprocedure87% –Pre-operativecare15% –Anesthesia35% –Post-operativecare49% •Surgeons –Selectioncriteriaforsurgeon40% –Numberofsurgeonsinvolved33% –Numberofinterventionsperformed bysurgeon11% JacquierI,BoutronI,RavaudP,Ann.Surgery,2006 7 Anextensionfornon-pharmacologictreatments. Theprocess. •30experts –Surgeons(n=7) –Cliniciansinvolvedinrehabilitation(n=1) –Cliniciansinvolvedineducation(n=1) –Cliniciansinvolvedinpsychotherapy(n=2) –Clinicalepidemiologists,biostatisticiens(n=14) –Editors(n=5) •Preliminarysurvey –Toidentifyitemstobediscussedbasedtheexperts’opinion •ConsensusmeetinginParis(2006) –Toachieveconsensusonamodifiedchecklist 8 Anextensionfornon-pharmacologictreatments. Thechecklist. • Complexityoftheintervention –Descriptionofthedifferentcomponentsofthe interventionsand,whenapplicable,descriptionofthe procedurefortailoringtheinterventions –Detailsofhowtheinterventionswerestandardised –Detailsofhowadherenceofcareproviderswiththe protocolwasassessedorenhanced. –Detailsoftheexperimentaltreatmentandcomparatoras theywereimplemented.(Newitem) • Blinding –thoseadministeringcointerventions –methodofblindinganddescriptionofthesimilarityof interventions 9 Anextensionfornon-pharmacologictreatments. Thechecklist. • Careprovidersandcenters –Eligibilitycriteriaforparticipantsand,whenapplicable, centresandthoseperformingtheinterventions.. –Whenapplicable,aqualitativedescriptionofcareproviders (casevolume,qualification,expertise,etc.)andcentres (volume)ineachgroup. • Clusteringeffect –Howsamplesizecalculation –Statisticalanalysis 10 Anextensionfornon-pharmacologictreatments. Theflowdiagram Randomized(n=….) Allocatedtointervention(n=…) Receivedallocatedintervention(n=…) Didnotreceiveallocatedintervention(give reasons)(n=…) Careproviders(n=),teams(n=), centres(n=)performingtheintervention Numberofpatientstreatedbyeachcare provider,teamandcentre(median=… [IQR,min,max]) Anextensionfornon-pharmacologictreatments. Thediffusion 11 BoutronI,etal.AnnInternMed2008 58and254timecited(Sept5th2011) Anextensionfornon-pharmacologictreatments. Thedissemination CONSORT NPT OtherCONSORT extension 2010CONSORTchecklist/ diagram JAMANONOYes,linktochecklist LancetNOYes,harmandclusterYeslinktoCONSORT website AnnInternMed Yes,linktothe publication Cluster,Herbaltherapy, Noninferiorityand equivalenceRCTs Yes,linktoCONSORT website BMJNONOYeslinktoCONSORT website PlosMedNONOYeslinktoCONSORT website NEJMNONONO AnnSurgNONOYeslinktoCONSORT website NeurorehabNeural Repair NONORefto2010publication AmJofPsychiatryNONOYeslinktoCONSORT website 12 Anextensionfornon-pharmacologic treatments.Impact •Nostudyassessingtheimpactofthisextension •Recentstudyonthereportingofflowdiagram (SallyHopewelletal.) –Crosssectionalreviewofallprimaryreportsof randomizedtrialswhichincludeaCONSORTflow diagramindexedinPubMedcoreclinicaljournalsfrom JulytoDecember2009. –236parallelgroupwithflowdiagram,120(51%) evaluatednonpharmacologictreatments –Noflowdiagramreportedaccordingtotheextension 13 Remainingchallenges •ToupdatetheextensionforCONSORTNPT –AccordingtotheCONSORT2010 –Newdevelopementsonthistopic 14 •Todevelopandevaluatedifferentmethodsof implementation –Instructiontoauthors –Useofchecklistcompletedbyauthors –Systematicassessmentofthecompliancetothe CONSORTstatementsbeforepeer-review 15 Remainingchallenges Conclusion •Thereisaneedtoimprovetransparencyof NPTtrials •Theimplementationofextensionofthe CONSORTNPTbyactivepolicyisneeded 16 17 Acknowledgments MohitBhandari,MarionCampbell,PhilipDevereaux, PeterC.Gøtzsche,TeodorP.Grantcharov,Jeremy Grimshaw,EthanA.Halm,ErikHendriks,Asbjørn Hróbjartsson,JohnIoannidis,AstridJames,Giselle Jones,RichardJLilford,RobinMcLeod,David Moher,AndrewJMolyneux,VictorM.Montori, CynthiaMulrow,AmyPlint,DrummondRennie,Peter MRothwell,PaulaP.Schnurr,KennethFSchulz, ChristophMSeiler,JudithStephenson,SimonG Thompson,GrahamThornicroft,DavidTorgerson, TomTreasure,PeterTugwell