Hvordan en guideline bliver til. Oxford-modellen Hindsgavl fredag d 18. sep 2015 Jeppe Schroll og Helga Gimbel.

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1 Hvordan en guideline bliver til. Oxford-modellen Hindsgavl fredag d 18. sep 2015 Jeppe Schroll og Helga Gimbel

2 Oxford vs Grade Oxford følger også principperne for EBM med PICO og systematiske søgninger og evt critical appraisal Oxford er let at bruge, også for non-RCTs Oxford er fleksibelt, men med risiko for at systematikken overses

3 Evidensbaseret medicin trin 1 Behandling Kontrol O Rod Jackson 2011 Patient + beh - beh + outcome - outcome P I C O

4 Evidensbaseret medicin trin 2 Find evidens for at besvare spørgsmålet Hvor skal vi søge? Hvad skal vi se efter?

5 Evidensbaseret medicin trin 3 Vurdér evidensen -G-Gradering af litteraturen Her er den vigtige forskel

6 PICO Level Therapy/Prevention, Aetiology/Harm PrognosisDiagnosisDifferential diagnosis/symptom prevalence study Economic and decision analyses 1aSR (with homogeneity*) of RCTsSR (with homogeneity*) of inception cohort studies; CDR† validated in different populations SR (with homogeneity*) of Level 1 diagnostic studies; CDR† with 1b studies from different clinical centres SR (with homogeneity*) of prospective cohort studies SR (with homogeneity*) of Level 1 economic studies 1bIndividual RCT (with narrow Confidence Interval‡) Individual inception cohort study with > 80% follow-up; CDR† validated in a single population Validating** cohort study with good††† reference standards; or CDR† tested within one clinical centre Prospective cohort study with good follow-up**** Analysis based on clinically sensible costs or alternatives; systematic review(s) of the evidence; and including multi- way sensitivity analyses 1cAll or none§All or none case-seriesAbsolute SpPins and SnNouts††All or none case-seriesAbsolute better-value or worse- value analyses †††† 2aSR (with homogeneity*) of cohort studies SR (with homogeneity*) of either retrospective cohort studies or untreated control groups in RCTs SR (with homogeneity*) of Level >2 diagnostic studies SR (with homogeneity*) of 2b and better studies SR (with homogeneity*) of Level >2 economic studies 2bIndividual cohort study (including low quality RCT; e.g., <80% follow-up) Retrospective cohort study or follow-up of untreated control patients in an RCT; Derivation of CDR† or validated on split- sample§§§ only Exploratory** cohort study with good††† reference standards; CDR† after derivation, or validated only on split-sample§§§ or databases Retrospective cohort study, or poor follow-up Analysis based on clinically sensible costs or alternatives; limited review(s) of the evidence, or single studies; and including multi-way sensitivity analyses 2c"Outcomes" Research; Ecological studies "Outcomes" Research Ecological studiesAudit or outcomes research 3aSR (with homogeneity*) of case- control studies SR (with homogeneity*) of 3b and better studies 3bIndividual Case-Control Study Non-consecutive study; or without consistently applied reference standards Non-consecutive cohort study, or very limited population Analysis based on limited alternatives or costs, poor quality estimates of data, but including sensitivity analyses incorporating clinically sensible variations. 4Case-series (and poor quality cohort and case-control studies§§) Case-series (and poor quality prognostic cohort studies***) Case-control study, poor or non- independent reference standard Case-series or superseded reference standards Analysis with no sensitivity analysis 5Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" Expert opinion without explicit critical appraisal, or based on economic theory or "first principles" Gradering ifølge Oxford modellen.

7 Level Therapy/Prevention, Aetiology/Harm 1aSystematic Reviews (with homogeneity*) of RCTs 1bIndividual RCT (with narrow Confidence Interval‡) 1cAll or none§ 2aSystematic Reviews (with homogeneity*) of cohort studies 2bIndividual cohort study (including low quality RCT; e.g., <80% follow-up) 2c"Outcomes" Research; Ecological studies 3aSystematic Reviews (with homogeneity*) of case-control studies 3bIndividual Case-Control Study 4Case-series (and poor quality cohort and case-control studies§§) 5Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" Gradering ifølge Oxford modellen. Behandling

8 De 4 biases Rekrutterings-bias Allokerings-bias Behandling Kontrol O Måle bias Outcome bias Rod Jackson 2011 Patient +-+- +-+-

9 BEHANDLINGSSTUDIER: Er resultaterne af trial valide?(Intern Validitet) Hvilket spørgsmål stillede studiet? 1a. R- Var patienterne randomiserede til deres behandling? 1b. R- Var grupperne sammenlignelige ved start af trial? 2a. A – Bortset fra den behandling, som patienterne blev randomiserede til, blev grupperne så behandlet ens? 2b. A – Var alle patienterne, der indgik I undersøgelsen med I analysen? – og blev de analyseret i den gruppe, som de blev randomiseret til? 3. M – Var målemetoderne objektive / blev patienterne og lægerne blindede I forhold til den behandling, som blev modtaget? Hvad var resultatet? 4a. O – Hvor stor var behandlings-effekt? 4a. O – Hvor præcist var estimatet på behandlingeffekten?

10 Op- og nedgradering Notes Users can add a minus-sign "-" to denote the level of that fails to provide a conclusive answer because: EITHER a single result with a wide Confidence Interval OR a Systematic Review with troublesome heterogeneity. Such evidence is inconclusive, and therefore can only generate Grade D recommendations.

11 IKKE ALLE NYE BEHANDLINGER ER GODE BEHANDLINGER

12 Evidensbaseret medicin trin 4 Anvend evidensen –Integrer den valide evidens med relevant information og foretag en evidensbaseret rekommandation EN NATIONAL GUIDELINE

13 Vil resultaterne hjælpe i omsorgen for vores patienter? (EksternValiditet) Før vi beslutter os for at anbefale resultaterne:  Er vores patienter så forskellige fra de patienter, der blev inkluderet I studiet, at resultaterne ikke kan anvendes?  Er behandlingen mulig I Danmark?  Vil de mulige fordele opveje de mulige bivirkninger ved behandlingen hos vores patienter? X-faktor: en evidensbaseret rekommandation

14 Rekommandationer A Konsistente grad I studier B Konsistente grad 2 og 3 studier eller ekstrapolationer fra grad 1 studier C Grad 4 studier eller ekstrapolationer fra grad 2 eller 3 studier D Grad 5 evidens eller problematiske inkonsistente eller inkonklusive studier af alle grader

15 GRADE og non-RCTS

16 GRADE i Sundhedsstyrelsen 20 millioner årligt Kun 10 PICOs pr guideline Fagkonsulent frikøbt 6mdr Metodekonsulent Søgekonsulent Projektleder Sommetider formand fra Sundhedsstyrelsen

17 For Oxford Det er det, som vi er vandt til. Det kan det samme som GRADE Det har også en løsning for non-RCTs

18 Imod Oxford Sundhedsstyrelsen anvender GRADE