Tõendusmaterjal ja selle hindamine. Tõenduspõhine meditsiin. Tõenduspõhised kliinilised otsused Esialgne mudel. Pärnus

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1 ja selle hindamine Pärnus Kaja-Triin Laisaar TÜ tervishoiu instituut Tõenduspõhine meditsiin Evidence-Based Medicine(EBM) is the integration of (1) best research evidence with (2) clinicalexpertiseand (3) patient values SackettDI et al, 2000 Tõenduspõhised kliinilised otsused Esialgne mudel Haynes RB et al,

2 Tõenduspõhised kliinilised otsused Uuendatud mudel Haynes RB et al, 2002 Tõenduspõhisuse püramiid ja uuringukavandid Uuringukavandid Q1: Milline on uurija eesmärk? Q2: Kas uurija sekkub või vaatleb? Q3: Kas uurimist alustatakse ekspositsioonist/sekkumisest või tulemist? Centre for Evidence-Based Medicine, University of Oxford 2

3 1 2 1 sekkumisuuring 2 vaatlusuuring Grimes DA et al, 2002 Valik uuringukavandeid randomized controlledtrial(rct) randomiseeritud kontrollitud uuring cohort study kohortuuring case-control study juhtkontrolluuring case series juhtuuring case report üksikjuhtuuring Rahvatervishoiu eesti-inglise seletav sõnastik, Tartu Ülikooli tervishoiu instituut Tõenduspõhisuse püramiid ja uuringukavandid 3

4 Meditsiiniline küsimus ja uuringukavandid Medical Center Library and Archives, Duke University i tasemed I. Originaalsed teadusuuringud II. Esimese astme tõendusmaterjali süntees kvalitatiivne = süstemaatiline ülevaade kvantitatiivne = metaanalüüs III. Ravijuhendid (ka käsitlusjuhendid) i kogumine, selle kvaliteedi hindamine (1) III. Olemasolevate ravijuhendite soovituste kasutamine ja nende tõendusmaterjali kontroll II. Süstemaatiliste ülevaadete ja metaanalüüside põhjal soovituste väljatöötamine (sh kogu protsessi kirjeldamine) Süstemaatiliste ülevaadete (ja metaanalüüside) tegemine (sh kogu protsessi kirjeldamine) 4

5 i kogumine, selle kvaliteedi hindamine (2) Eesti ravijuhendite koostamise käsiraamat joonis 6.1 lk 31 III. Olemasolevad ravijuhendid tõendusmaterjalina Ravijuhendid tõendusmaterjalina Ravijuhendite allikad (1) Ravijuhendi koostajatele teadaolevad juhendid - erialaühenduste kodulehed (2) Ravijuhendite otsing e-andmebaasidest - ravijuhend ja/või teaduspublikatsioon -keel - koostamise aeg NB! Kasulik link ravijuhendite otsimiseks: The AGREE Enterprise 5

6 Ravijuhendite hindamine ja valik (1) Töövahend ravijuhendi väljatöötamise metoodilise täpsuse ja läbipaistvuse hindamiseks, et lahendada ravijuhendite ebaühtlase kvaliteedi probleem AGREE II Appraisal of Guidelines for REsearch and Evaluation instrument -6 teemat (kokku 23 osa) + üldhinnang (2 osa) - iga osa kohta hinnanguskaala iga teema kohta eraldi punktisumma NB! Iga ravijuhendit peaks hindama 2(4) hindajat AGREE Research Trust Ravijuhendite hindamine ja valik (2) AGREE II on töövahend hindamaks mistahes haigus(t)e valdkonda puudutavaid ravijuhendeid, milles käsitletakse kõiki tervishoiuga seotud samme, sh terviseedendus, rahvatervis, sõeluuringud, diagnoosimine, ravi või (muud) sekkumised. mis hetkeseisuga ei ole mõeldud (1) tervishoiukorralduslikke küsimusi käsitlevate juhenddokumentide ega (2) tervishoiutehnoloogiate hindamiseks. Ravijuhendite hindamine ja valik (3) Tutvu AGREE II töövahendi kasutusjuhendiga -Kirjeldus Üldjoontes osa aluseks oleva käsitlusviisi kirjeldus ja näited - Kust otsida Millistes juhendi osades või peatükkides vastav teave tavaliselt asub - Kuidas hinnata Kriteeriumid Kaalutlused Tutvu hinnatava ravijuhendi nn. täisdokumendiga (sh lisadega) 6

7 Ravijuhendite hindamine ja valik (4) Ravijuhendi hindamise teemad ja osad: I. Käsitlusala ja eesmärk Ravijuhendi üldine eesmärk; konkreetsed terviseküsimused; sihtrühm/ rahvastik (osad 1 3) II. Huvirühmade kaasatus Asjakohaste huvirühmade kaasatus; kavandatud kasutajate seisukohtade esindatus (osad 4 6) III. Koostamise täpsus Tõendite kogumise ja analüüsi protsess; soovituste sõnastamine ja nende uuendamise meetodid (osad 7 14) Ravijuhendite hindamine ja valik (5) Ravijuhendi hindamise teemad ja osad: IV. Esitamise selgus Ravijuhendi keel, ülesehitus ja vorm (osad 15 17) V. Kasutatavus Võimalikud takistused ja hõlbustajad juhendi rakendamisel; selle kasutuselevõtu-strateegiate parandamine, kasutamise võimalikud mõjud ressurssidele (osad 18 21) VI. Koostajate sõltumatus Soovituste sõnastus, nende võimalikud nihked huvide konflikti tõttu (osad 22 23) Üldhinnang Ravijuhendi üldine kvaliteet; kas seda juhendit soovitatakse kasutada Ravijuhendite hindamine ja valik (6) Ravijuhendi hindamise töövahendi AGREE II kasutamise käsiraamat 7

8 II. Süstemaatilised ülevaated tõendusmaterjalina Süstemaatiliste ülevaadete allikad (1) Ravijuhendi koostajatele teadaolevad süstemaatilised ülevaated (2) Eelnevalt väljavalitud ravijuhendite viidete nimekiri References (3) Süstemaatiliste ülevaadete otsing e-andmebaasidest -süstemaatiline ülevaade või -keel - koostamise aeg Süstemaatiliste ülevaadete hindamine ja valik (1) Süstemaatilise ülevaate kvaliteedi hindamiseks: A Measurement Tool to Assess Systematic Reviews (AMSTAR) AMSTAR-tööriist käsiraamatu tabel 6.2 lk

9 Süstemaatiliste ülevaadete hindamine ja valik (2) AMSTAR-tööriist: 11 küsimust 1. Kas oli koostatud eelnev uuringukavand? 2. Kas uuringute otsimine ja andmete väljavõtmine oli dubleeritud? 3. Kas oli teostatud laialdane kirjanduse otsing? 4. Kas oli kasutatud väljaande liiki (sh avaldamata uuringuid) kui ühte kaasamise kriteeriumit? Süstemaatiliste ülevaadete hindamine ja valik (3) AMSTAR-tööriist: 11 küsimust 5. Kas (kaasatud ja välja jäetud) uuringute loetelu on esitatud? 6. Kas kaasatud uuringute tunnused on esitatud? 7. Kas kaasatud uuringute teaduslikku kvaliteeti on hinnatud ja dokumenteeritud? 8. Kas järelduste sõnastamisel on kaasatud uuringute teaduslikku kvaliteeti sobival viisil kasutatud? Süstemaatiliste ülevaadete hindamine ja valik (4) AMSTAR-tööriist: 11 küsimust 9. Kas uuringutulemuste kombineerimise meetodid olid kohased? 10. Kas on hinnatud nn. publitseerimisvigade tõenäosust? 11. Kas on avaldatud huvide konflikti? Kui mitu süstemaatilist ülevaadet lähtu uusimast Kui ülevaade üle 2 aasta vana kaalu selle täiendamist Ei saa anda JAH-vastust küsimustele 1 ja 11 jäta ülevaade kõrvale 9

10 I. Randomiseeritud kontrollitud uuringud tõendusmaterjalina Randomiseeritud kontrollitud uuringute allikad (1) Ravijuhendi koostajatele teadaolevad randomiseeritud kontrollitud uuringud (2) Randomiseeritud kontrollitud uuringute otsing e- andmebaasidest - uuringutüüp (kuidas nimetada) -keel - koostamise aeg Randomiseeritud kontrollitud uuringute hindamine ja valik Mida ühe randomiseeritud kontrollitud uuringu juures metoodiliselt karta? Vaata: (1) CONSORT Statement Checklist (2) Cochrane isüstemaatilistes ülevaadetes kaasatud uuringute nihkevõimaluste kokkuvõtteid ingl. k. Risk ofbiassummary näide: Cochrane SR lk 11(13 ja 21(23) 10

11 I. Muud uuringud* tõendusmaterjalina *Uuringud v.a randomiseeritudkontrollitud uuringud Muude uuringute hindamine ja valik Hinda oma võimalusi eelkõige tööjõudu ja aega Transparent Reporting of Evaluations with Nonrandomized Designs TREND Statement Checklist 11

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