ILCOR og utvikling av retningslinjer

Transkript

1 ILCOR og utvikling av retningslinjer Theresa M. Olasveengen Forsker NAKOS

2 Disposisjon Hvem lager retningslinjene? Hvordan har man gått frem?

3 Hvem lager retningslinjene?

4 ILCOR International Liaison Committee on Resuscitation ble dannet i 1992 Mål: skape et felles forum for alle organisasjonene som utvikler retningslinjer for HLR. Medlemmer; American Heart Association (AHA) European Resuscitation Council (ERC) Heart and Stroke Foundation of Canada (HSFC) Australian and New Zealand Committee on Resuscitation (ANZCOR) Resuscitation Councils of Southern Africa (RCSA) Inter American Heart Foundation (IAHF) Resuscitation Council of Asia (Japan, Korea, Singapore, Taiwan).

5 ILCOR Advanced Life Support Jas Soar (ERC) Clifton Callaway (AHA) Neonatal life support Jeffrey Perlman (AHA) Jonathan Wyllie (ERC) Basic Life Support Gavin Perkins (ERC) Andrew Travers (HSFC) Education, Implementation and Teams Judith Finn (ANZCOR) Farhan Bhanji (HSFC) Pediatrics Ian Maconochie (ERC) Allan de Caen (HSFC) First Aid David Zideman (ERC) Eunice Singletary (AHA) Acute Coronary Syndromes Nikolaos Nikolaou (ERC) Michelle Welsford (AHA)

6 «Desken» Co-chairs Definerer og prioriterer emner og spørsmål Task Force/ Writing group Oppsummerer og graderer vitenskapen Evidence reviewers

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8 ILCOR ERC NRR

9 Hvordan har man gått frem?

10 Utvikling av retningslinjene Utvikling av spørsmål Mulighet for publikum å komme med innspill Diskusjon om anbefalinger Prioritering/ utdeling av spørsmål Mulighet for publikum å komme med innspill Litteraturgjennomgang Kunnskapsoppsummering

11 PICO-spørsmål Målet er å stille et spørsmål som det er mulig å besvare; P patient/population I intervention C control O outcome

12 Mitt møte med PICO

13 Eksempel 1 Population: Adults and children with suspected opioid-associated cardio / respiratory arrest in the pre-hospital setting Intervention: Bystander naloxone administration (intramuscular or intranasal), in addition to standard CPR Comparison: Standard CPR only Outcomes: Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year. (9-critical) Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year. (8- critical)

14 ((((((("Narcotics"[Mesh] OR "Narcotics" [Pharmacological Action] OR Oxycodone[ TIAB] or hydrocodone[tiab] or heroin[tiab] or morphine[tiab] or methadone[tiab] or codeine[tiab] or fentanyl[tiab] or opiate[tiab] or opiates[tiab] or opioid[tiab] or opioids[tiab] OR Hydromorphone[TIAB] or vicodin[tiab] or Demerol[TIAB] or oxycontin[tiab] or Tramadol[TIAB] or Meperidine[TIAB] or opium[tiab] or narcotic [TIAB] OR narcotics[tiab] OR "Opioid-Related Disorders"[Mesh]) AND ("Drug O verdose"[mesh] or "poisoning" [Subheading] or "Poisoning"[Mesh:NoExp] or "toxicity" [Subheading] or overdose[tiab] OR overdosed[tiab] or overdosing[tiab] or toxicity[tiab] or poisoning[tiab])))) AND (("Heart Arrest"[Mesh] or "respiratory insufficiency"[mesh] or "cardiac arrest"[tiab] or "cardiovascular arrest"[tiab] or "heart arrest"[tiab] or "cardiopulmonary arrest"[tiab] or "cardio-pulmonary arrest«[tiab] or "respiratory arrest"[tiab] or "ventilatory depression"[tiab] or "respiratory depression"[tiab] or hypoventilation[tiab]))) AND (("Resuscitation"[Mesh] OR "cardiopulmonary resuscitation"[tiab] or "cardio-pulmonary resuscitation"[tiab] or CPR[TIAB] or "chest compression"[tiab] or "chest compressions"[tiab] OR "basic life support"[tiab] or BLS[TIAB] or "cardiac massage"[tiab] or "heart massage«[tiab] OR "Naloxone"[Mesh] OR "Narcotic Antagonists"[Mesh] or naloxone[tiab] or naloxon[tiab] or narcan[tiab] or "narcotic antagonist"[tiab] or "narcotic antagonists"[tiab] OR "opioid antagonist"[tiab] OR "opioid antagonists"[tiab])))) NOT ((animals[mh] NOT humans[mh]) NOT ("letter"[pt] OR "comment"[pt] OR "editorial"[pt] or Case Reports[ptyp])) 891 0

15 PICO Population: Adults and children at risk of suspected cardiac/respiratory arrest due to opioids in the prehospital setting Intervention: Opioid overdose response education with or without naloxone distribution Comparison: No overdose response education or overdose prevention education only Outcomes: Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year. (9-critical) Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year. (8- critical)

16 ((((((("Narcotics"[Mesh] OR "Narcotics" [Pharmacological Action] OR Oxycodone[ TIAB] or hydrocodone[tiab] or heroin[tiab] or morphine[tiab] or methadone[tiab] or codeine[tiab] or fentanyl[tiab] or opiate[tiab] or opiates[tiab] or opioid[tiab] or opioids[tiab] OR Hydromorphone[TIAB] or vicodin[tiab] or Demerol[TIAB] or oxycontin[tiab] or Tramadol[TIAB] or Meperidine[TIAB] or opium[tiab] or narcotic [TIAB] OR narcotics[tiab] OR "Opioid-Related Disorders"[Mesh]) AND ("Drug O verdose"[mesh] or "poisoning" [Subheading] or "Poisoning"[Mesh:NoExp] or "toxicity" [Subheading] or overdose[tiab] OR overdosed[tiab] or overdosing[tiab] or toxicity[tiab] or poisoning[tiab])))) AND (("Heart Arrest"[Mesh] or "respiratory insufficiency"[mesh] or "cardiac arrest"[tiab] or "cardiovascular arrest"[tiab] or "heart arrest"[tiab] or "cardiopulmonary arrest"[tiab] or "cardio-pulmonary arrest«[tiab] or "respiratory arrest"[tiab] or "ventilatory depression"[tiab] or "respiratory depression"[tiab] or hypoventilation[tiab]))) AND (("Resuscitation"[Mesh] OR "cardiopulmonary resuscitation"[tiab] or "cardio-pulmonary resuscitation"[tiab] or CPR[TIAB] or "chest compression"[tiab] or "chest compressions"[tiab] OR "basic life support"[tiab] or BLS[TIAB] or "cardiac massage"[tiab] or "heart massage«[tiab] OR "Naloxone"[Mesh] OR "Narcotic Antagonists"[Mesh] or naloxone[tiab] or naloxon[tiab] or narcan[tiab] or "narcotic antagonist"[tiab] or "narcotic antagonists"[tiab] OR "opioid antagonist"[tiab] OR "opioid antagonists"[tiab])))) NOT ((animals[mh] NOT humans[mh]) NOT ("letter"[pt] OR "comment"[pt] OR "editorial"[pt] or Case Reports[ptyp])) We suggest offering opioid overdose response education, with or without naloxone.

17 Så skal man GRADE

18 GRADE Ansees for å være det beste verktøyet for å oversette kunnskapsoppsummering til kliniske retningslinjer. Sterkt fokus på effektmålene - overlevelse Graderer systematisk kvalitet på forskningsresultatene og styrken på behandlingsanbefalingene

19 GRADE Inngangsbilletten til GRADE er at studiene inneholder alle elementene fra PICO spørsmålet. Nøyaktig.

20 Eksempel 2 Population: students who are taking BLS courses Intervention: any specific interval for update or retraining Comparison: standard practice (i.e. 12 or 24 monthly) Outcome: patient outcomes (9-Critical) skill performance in actual resuscitations (8-Critical) skill performance at 1 year (6-Important) skill performance at course conclusion (5-Important) cognitive knowledge (4-Important)

21 GRADE Hvordan var det da med re-trening for legfolk; Effekt av re-trening vs. når begynner man å glemme?

22 Eksempel 2

23 Så er det bare å legge sammen alle effektmålene. patient outcomes (9-Critical) skill performance in actual resuscitations (8-Critical) skill performance at 1 year (6-Important) skill performance at course conclusion (5-Important) cognitive knowledge (4-Important)

24 skill performance Kompresjonsdybde Hands-off tid Kompresjonsrate Egen komponert score D Egen komponert score B Ventilasjonsvolum Egen komponert score C Ventilasjonsfrekvens Egen komponert score E Hands-off ratio Antall kompresjoner per minutt Egen komponert score A There is insufficient evidence to recommend the optimum interval

25 GRADE Kvalitet: Høy Studie: Randomisert/ kontrollert Middels Lav Observasjon Veldig lav

26 GRADE 5 faktorer som reduserer tilliten til studiene: 1) Studiekvalitet - risiko for systematiske feil/skeivheter 2) Konsistens - samsvarer studiene 3) Direkthet - er populasjonen og intervensjonene relevante? 4) Presisjon nok pasienter/hendelser? Konfidensintervall? 5) Rapporteringsskeivheter sannsynlig at viktig forskning ikke er publisert?

27 GRADE 3 faktorer som øker tilliten til studiene: 1) Sterk assosiasjon/stor effektstørrelse (> x2) 2) Dose-respons 3) Effekt tross forventet konfundering

28 Eksempel 3 Population: Organisations that provide care for patients in cardiac arrest in any setting Intervention: Implementation of resuscitation guidelines Comparison: No such use Outcomes: survival to 180 days with good neurological outcome (9-critical) survival to hospital discharge (8-critical) bystander CPR performance (6-important) return of spontaneous circulation (6-important)

29 5 faktorer som reduserer tilliten til studiene: 1) Studiekvalitet : Før/etter-studier, stor risiko for skeivheter; kortere responstid? flere utplasserte hjertestartere? bedre intensivbehandling? 2) Konsistens: Selvfølgelig samsvarer ikke studiene. 3) Direkthet: Noen ser bare på bevitnet VF andre hele populasjonen, mange hadde egen vri på retningslinjene/praksisendringene. 4) Presisjon ok! 5) Rapporteringsskeivheter: Mye mer sannsynlig å få publisert om man klarer å vise positive resultater.

30 Kvalitet: Høy Middels Studie: Randomisert/ kontrollert We recommend implementation of resuscitation guidelines. Lav Observasjon Veldig lav

31 Hva ligger bak anbefalingene? Nytte: Store positive effekter? Viktig nok problem? Noen som bryr seg? Sikker på resultatene? Kan det utjevne sosiale forskjeller? Kost: Lite negative/bi-effekter? Ressurskrevende? Lar det seg implementere? Akseptabelt for nøkkelpersoner?

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33 GRADE speak Consensus on science: En oppsummering av all vitenskapen man fant som besvarte PICO spørmålet etter tur og orden, sortert etter viktiste utfall til minst viktige utfall (med alle svakhetene satt i parentes) Treatment Recommendation Selve behandlingsanbefalingen We recommend = høy/middels kvalitet (sannsynligvis riktig) We suggest = lav/veldig lav kvalitet (vet ikke, men virker rimelig) Values and preferences and task force insights Redegjørelse for hvordan man har veid vitenskapen mot usikkerheten, kost/nytte etc.

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35 Key ingredients for improving survival Executive Summary ERC Guidelines 2015

36 Dispatcher instructions Consensus on science: For the critical outcome of survival, we identified very-low quality evidence from 3 RCTs The level of evidence was downgraded for risk of bias, indirectness, and imprecision. Metaanalysis of these trials found an absolute survival benefit of 2.4% (95% CI, 0.1% 4.9%) in favor of telephone-assisted continuous chest compressions over telephone-assisted traditional CPR (number needed to treat [NNT], 41; 95% CI, ; relative risk [RR], 1.22; 95% CI, ). 38

37 Dispatcher instructions Treatment recommendation: We recommend that dispatchers provide chest compression only CPR instructions to callers for adults with suspected OHCA (strong recommendation, low-quality evidence)

38 Dispatcher instructions Values, preferences, and task force insights: In making these recommendations, we placed a higher value on the initiation of bystander CPR and a lower value on the harms of performing CPR on patients who are not in cardiac arrest. We recognize that the evidence in support of these recommendations comes from randomized trials and observational data of variable quality. However, the available evidence consistently favors telephone CPR protocols that use a compression-only CPR instruction set, suggesting a dose effect that is, quick telephone instructions in chest compressions result in more compressions and faster administration of CPR to the patient.

39 Guidelines prosessen er en utrolig omfattende, grunndig og gjennomsiktig prosess som er verdt å ha tillit til. Kunnskapsgrunnlaget som ligger til grunn er tynt siste ord er ikke sagt!

40 Takk for meg!