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klinikuri kvlevebis dizaini

klinikuri kvlevebis dizaini. kikviZe marina Tbilisi, tfdec 2010. mizani. klinikuri kvlevebis dizainis ZiriTadi variantebis analizi kvlevebis sxvadasxva saxis gegmis susti da Zlieri mxareebis aRwera

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klinikuri kvlevebis dizaini

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  1. klinikuri kvlevebis dizaini kikviZe marina Tbilisi, tfdec 2010

  2. mizani • klinikuri kvlevebisdizainis ZiriTadi variantebis analizi • kvlevebis sxvadasxva saxis gegmis susti da Zlieri mxareebis aRwera kvlevis dagegmvis stadiaze gaweuli didi gulisxmeva da Sroma saSualebas mogvcems kvlevis Catarebisas Tavi avaridoT potenciur Secdomebs da TvalnaTvliv davinaxoT mimarTuleba Sedegebis srulyofili analizisaTvis.

  3. klinikuri kvlevebis dizaini klinikuri kvlevis dizainiwarmoadgens kvlevis Catarebis gegmas. konkretuli klinikuri kvlevis dizaini ganpirobebulia imaze, Tu ra mizani daisaxa mkvlevarma.

  4. kiTxvebi, romlebic gansazRraven kvlevis dizains • ra mizniT tardeba kvleva? • rogoria hipoTezis formulireba? • ra mniSvneloba aqvs hipoTezas? - problemas aqvs samecniero mniSvneloba? - problemas aqvs klinikuri mniSvneloba? • rogori formulireba unda mivceT kvlevis mizans, rom davamtkicoT an uarvyoT hipoTeza? • kvlevis romeli gegma ufro metad Seesatyviseba dasaxuli miznis miRwevas?

  5. klinikuri kvlevebi observaciuli eqsperimentuli aRwerilobiTi analitikuri • klinikuri cdebi /Clinical trials • meta-analizi • /Meta-analysis • SemTxvevebis aRwera/Case reports • SemTxvevaTa seriebis kvleva/Case series • erTmomentiani kvleva • gamokiTxvebi • «SemTxveva- kontroli»/Case-control study • kohortuli /Cohort study klinikuri kvlevebis klasifikacia

  6. «SemTxveva-kontroli» kvlevis sqema riskis faqtoris eqspozicia daavadeba + + sakvlevi jgufi - + _ sakontrolo jgufi - dro monacemTa Segroveba

  7. kvleva «SemTxveva-kontroli» *Subjects with disease (cases) –avadmyofebi(SemTxvevebi),Subjects without disease (controls) – janmrTelebi(kontroli), Exposed – ganicades zegavlena, Not Exposed – arganicades zegavlena.

  8. kohortuli kvlevis sqema daavadeba + eqsponirebuli riskis faqtorisadmi riskis populacia - dro + - ar eqsponirebuli riskis faqtorisadmi

  9. kohortuli kvleva *Population–populacia,Disease–daavadeba aria,Without disease – daavadeba ar aris, Exposed–ganicades zegavlena,Not exposed –ar ganicades zegavlena,

  10. «SemTxveva-kontroli» retrospeqtiuli kriteriumi: Sansebis Tanafardoba dabali Rirebuleba sakvlev pirTa naklebi raodenoba efeqti → mizezi kohortuli prospeqtiuli kriteriumi: SedarebiTi riski maRali Rirebuleba sakvlev pirTa meti raodenoba mizezi → efeqti «SemTxveva-kontrolisa» da kohortuli kvlevebis Sedareba

  11. Sansebis Tanafardoba

  12. SedarebiTi riski

  13. kvlevis dizaini damokidebulia Semdeg faqtorebze: • sakontrolo jgufi (Control group) • randomizacia (Randomization) • dabrmaveba (Blinding) • kvlevis struqtura (Trial format) • klinikuri fenotipis gansazRvra (Clinical Phenotyping) • sazRvrebi (Endpoints)

  14. kontrolis saxeebi placebo-kontroli • pacienTaerTi an ramdenime jgufis, romlebsac utardebaT mkurnaloba Sedareba pacienTa jgufTan, romlebic iReben placebos. aqtiuri mkurnaloba • pacienTaerTi an ramdenime jgufis Sedareba, romlebic iReben sxvadasxva preparatebs. istoriuli kontroli • mimdinare kvlevis Sedegebis Sedareba warsulSi Catarebuli msgavsi kvlevebis SedegebTan.

  15. kontrolis saxeebi kontroli mkurnalobis gareSe • pacienTaori jgufis Sedareba, romelTagan mxolod erTi jgufi iRebs mkurnalobas. gamoyenebuli dozebis Sedareba paralelur kontrolSi • pacienTajgufebis Sedareba, romlebic iReben erT preparats sxvadasxva dozebSi.

  16. randomizacia • iZleva garantias, rom avadmyofTa ganawileba jgufebSi iqneba SemTxveviTi da masze ar imoqmedebs arc mkvlevaris subieqtivizmi da arc sistemuri Secdoma. • qmnis statistikuri analizis Catarebis safuZvels samkurnalo efeqtis monacemTa raodenobrivi SefasebisaTvis. • brma meTodTan erTobliobaSi saSualebas iZleva Tavi avaridoT avadmyofTa arCevisa da mkurnalobis daniSvnasTan dakavSirebul sistemur Secdomebs.

  17. randomizaciis meTodebi • martivi randomizacia • kvlevis Sesadarebel jgufebSi monawileTa SemTxveviTi ganawilebis wesi (mag., SemTxveviTi ricxvebis tabulis gamoyenebiT). • randomizacia blokebs SigniT • kvlevaSi CarTuli pacientebis saerTo raodenobidan yalibdeba blokebi TiToeulSi pacienTa luwi ricxviT. • TiToeuli blokis SigniT naxevar pacientebs eZlevaT mkurnaloba a, meore naxevars ki – b. • stratifikacia • pacientebis randomizaciadafuZnebulia faqtorze, romelic, rogorc varaudoben, zegavlenas axdens kvlevis Sedegebze (mag., bavSTa asaki).

  18. dabrmaveba • Ria kvleva _ mkvlevarmac da pacientmac ician, Tu ra mkurnaloba tardeba. • martivi brma meTodi _ mkvlevarma icis, xolo pacientma – ara, ra saxis mkurnaloba tardeba (Zalze iSviaTad - piriqiT). • ormagi brma meTodi _ arcmkvlevarma, arc pacientma ar ician, ra saxis Careva tardeba

  19. kvlevebis struqtura ganixileba klinikuri kvlevebis dizainis 3 ZiriTadi varianti : • klinikuri kvleva erT jgufSi (single group design) • klinikuri kvleva paralelur jgufebSi (parallel group design) -faqtoruli modeli - araerTgvarovani modeli • klinikuri kvleva “jvaredin” modelSi (crossover group design)

  20. klinikuri kvlevebi erT jgufSi klinikuri kvlevis Catarebisas erT jgufSi yvela pacienti iRebs erTi da igive eqsperimentul mkurnalobas. kvlevis es modeli gulisxmobs mkurnalobis Sedegebis Sedarebas sawyiss mdgomareobasTan. Sesabamisad, randomizacia am dros ar tardeba.

  21. klinikuri kvlevebi erT jgufSi klinikuri kvleva modeli erT jgufSi SeiZleba gamovsaxoT: skriningi _ CarTva _ sawyisi mdgomareoba _ mkurnaloba _ gamosavali

  22. klinikuri kvlevebi erT jgufSi uaryofiTi mxare: Sedarebis jgufis ar arseboba. Sesabamisad, ver xerxdeba aqsperimentuli mkurnalobis efeqtebis diferencireba sxva cvladebis efeqtebisagan.

  23. klinikuri kvlevebi paralelur jgufebSi klinikuri kvlevebis Catarebisas paralelur jgufebSi sxvadasxva jgufis pacientebs eniSnebaT gansxvavebuli mkurnaloba. statistikuri sarwmunoebis misaRwevad (sistematikuri Secdomebis gamosaricxavad), am modelis dros tardeba randomizacia.

  24. klinikuri kvlevebi paralelur jgufebSi randomizacia mkurnaloba a Sedegebis Sefaseba sakvlevi pirebi mkurnaloba b

  25. klinikuri kvlevebi paralelur jgufebSi *Population–populacia,Assessment–gamokvleva,Eligible and willing subjects – Sesatyvisi da monawileobaze Tanaxma pacientebi, Randomisation–randomizacia,Test–sacdeli mkurnaloba,Control – sakontrolo jgufi.

  26. klinikuri kvlevebi paralelur jgufebSi am modelis ilustracia: skriningi _ CarTva _mosamzadebeli periodi _ sawyisi mdgomareoba _ randomizacia _ mkurnaloba a _ gamosavali a mkurnaloba b _ gamosavali b sadac a, b – sxvadasxva mkurnalobaa an s/s doza an placebo.

  27. klinikuri kvlevebi paralelur jgufebSi uaryofiTi mxare: kvlevis es modeli ZviradRirebulia, xangrZlivi da saWiroebs mravalricxovan dasakvirvebel jgufs (rodesac sakvlevi movlenis ganviTaTrebis sixSire dabalia). dadebiTi mxare: _ metad obieqturia mkurnalobis efeqturobis gansazRvrisas da zusti daskvnebis formulirebisas. klinikur kvlevebs paralelur jgufebSi yvelaze xSirad iyebeben kvlevebis Catarebis dros. zogjer kvlevebis paralelur jgufebSi Catarebisas iyeneben an faqtorul an araerTgvarovan modelebs.

  28. faqtoruli modeli faqtoruli modeli–es aris dizaini dafuZnebuli or an met paralelur jgufze. mas iyeneben, rodesac Seiswavlian sxvadasxva preperatebis kombinacias (an preparatis sxvadasxva dozebs). mas xSirad iyeneben kombinirebuli preparatebis SefasebisaTvis. uaryofiTi mxare: mravalricxovan sakvlev jgufs da Sedegad, kvlevis Catarebisas danaxarjis gazrda.

  29. faqtoruli modeli mkurnaloba a mkurnalobab sakvlevi pirebi Sefaseba mkurnaloba a+b placebo

  30. araerTgvarovani modeli (“Terapiis Sewyveta”)Withdrawal (Discontinuation) Design • kvlevis am modelis dros dasawyisSi yvela pacienti iRebs eqsperimentuli mkurnalobas Semdeg ki, eqsperimentuli mkurnalobis gasagrZeleblad xdeba Sesabamisi reaqciebis mqone pacientebis randomizacia brma meTodis an placebos gamoyenebiT. • araerTgvarovani modeli Cveulebriv gamoiyeneba eqsperimentuli mkurnalobis efeqturobis Sesafaseblad preparatis miRebis Sewyvetisa da recidivis an remisiis registraciis gziT mkurnalobaze reaqciis gaCenisTanave.. • kvlevis es dizaini gansakuTrebiT efeqturia im preparatebis Sesafaseblad, romlebic Zneladgansakurnebeli daavadebebis TerapiaSi gamoiyeneba. aseTi kvlevebis Catarebisas pacientTa mxolod mcere procenti pasuxobs mkurnalobaze. • am dizains iyeneben, agreTve recidivebis Seswavlis drosac.

  31. araerTgvarovani modeli araerTgvarovani modelis sqema: skriningi _ CarTva _ eqsperimentuli mkurnaloba _ reaqcia mkurnalobaze _ mkurnalobaze mopasuxe pacientTa randomizacia _ mkurnaloba. uaryofiTi mxareebi: • mravalricxovani sakvlevi jgufi, • xangrZlivi kvleva, • eTikis sakiTxebi (SesaZlebelia saWiro gaxdes im preparatis moxsna, romelic pacientis mdgomareobis gaunjobesebas iwvevda).

  32. klinikuri kvlevebi “jvaredin” modelSi • pacientebs randomizaciis gziT yofen jgufebad, Semdeg maT utardebad erTnairi mkurnalobis kursebi, magram sxvadasxva TanmimdevrobiT. rogorc wesi, mkurnalobis kursebs Soris aris e.w. “gamorecxvis” periodi, rom wina mkurnalobis kursma zegavlena ar moaxdinos mis Semdgomze. • kvlevis es dizaini ufro iafia, vinaidan sakvlev pacientTa did jgufs ar saWiroebs.

  33. klinikuri kvlevebi “jvaredin” modelSi randomizacia gamorecxvis periodit gamorecxvis periodi Rx A Rx A monacemTa analizi sakvlevi pirebi Rx B Rx B gamosavali gamosavali

  34. klinikuri kvlevebi “jvaredin” modelSi Двухпериодное клиническое испытание с перекрестным дизайном. *Population–populacia,Assessment–gamokvleva,Eligible and willing subjects – Sesatyvisi da monawileobaze Tanaxma pacientebi, Randomisation–randomizacia,Test–sacdeli mkurnaloba,Control – sakontrolo jgufi.

  35. klinikuri kvleva “jvaredin” modelSi am modelis sqema: skriningi _ mosamzadebeli periodi _ mdgomareobis kontroli _ randomizacia _ mkurnaloba a 1 jgufSi da mkurnaloba b 2 jgufSi _ gamorecxvis periodi _ mkurnaloba b1 jgufSi da mkurnaloba a2 jgufSi.

  36. klinikuri fenotipis gansazRvra • CarTva/gamoricxvis kriteriumebi gansazRvraven sakvlev klinikur fenotips. • CarTva/gamoricxvis kriteriumebi dakavSirebulia efeqturobisa da usafrTxoebis sakiTxvebTan.

  37. kvlevis sazRvrebi • gamosavlis zusti gansazRvra maRalxarisxiani kvlevis Catarebis saSualebas iZleva. • xisti (mag., sikvdili) an rbili (mag., sicocxlis xarisxi (QOL) - Sesabamisi kiTxvaris gamoyenebiT miRebuli monacemebis safuZvelze). • pirveladi (mag., arteriuli wneva antihipertenziuli Terapiisas) an meoradi (mag., insulti miokardiumis infarqtis dros).

  38. ra ganapirobebs kvlevis warmatebiT Catarebas: • klinikuri problemis aqtualuroba. • klinikuri fenotipis swori gansazRvra. • ramdenad kargad asaxavs sakvlev avadmyofTa jgufi mTeli populaciis Tvisebebs. • ramdenad Seesabameba kvlevis mizani dizains. • adeqvaturi statistikuri analizis Catareba.

  39. gmadlobT yuradRebisaTvis

  40. Sample size Размер выборки зависит от • величины различия в частоте исходов между группами (величина эффекта) • альфа-ошибки (вывода об эффективности лечения, которого на самом деле нет,0,05=1/20) • бета-ошибки (0,20т.е.20%) • природы данных

  41. Таблица случайных чисел

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