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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

klinikuri kvlevebis dizaini

kikviZe marina

Tbilisi, tfdec

2010


Mizani
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.


Klinikuri kvlevebis dizaini1
klinikuri kvlevebis dizaini

klinikuri kvlevis dizainiwarmoadgens kvlevis Catarebis gegmas.

konkretuli klinikuri kvlevis dizaini ganpirobebulia imaze, Tu ra mizani daisaxa mkvlevarma.


Kitxvebi romlebic gansazrraven kvlevis dizains
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?


Klinikuri kvlevebis klasifikacia

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


Klinikuri kvlevebis dizaini

«SemTxveva-kontroli» kvlevis sqema

riskis faqtoris eqspozicia

daavadeba

+

+ sakvlevi jgufi

-

+

_ sakontrolo jgufi

-

dro

monacemTa Segroveba


Kvleva semtxveva kontroli
kvleva «SemTxveva-kontroli»

*Subjects with disease (cases) –avadmyofebi(SemTxvevebi),Subjects without disease (controls) – janmrTelebi(kontroli), Exposed – ganicades zegavlena, Not Exposed – arganicades zegavlena.


Klinikuri kvlevebis dizaini

kohortuli kvlevis sqema

daavadeba

+

eqsponirebuli riskis faqtorisadmi

riskis

populacia

-

dro

+

-

ar eqsponirebuli riskis faqtorisadmi


Kohortuli kvleva
kohortuli kvleva

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


Semtxveva kontrolisa da kohortuli kvlevebis sedareba

«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




Kvlevis dizaini damokidebulia semdeg faqtorebze
kvlevis dizaini damokidebulia Semdeg faqtorebze:

  • sakontrolo jgufi (Control group)

  • randomizacia (Randomization)

  • dabrmaveba (Blinding)

  • kvlevis struqtura (Trial format)

  • klinikuri fenotipis gansazRvra (Clinical Phenotyping)

  • sazRvrebi (Endpoints)


K ontrolis saxeebi
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.


K ontrolis saxeebi1
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.


Randomizacia
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.


Randomizaciis metodebi
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).


Dabrmaveba
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


Kvlevebis struqtura
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)


Klinikuri kvlevebi ert jgufsi
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.


Klinikuri kvlevebi ert jgufsi1
klinikuri kvlevebi erT jgufSi

klinikuri kvleva modeli erT jgufSi SeiZleba gamovsaxoT:

skriningi _ CarTva _ sawyisi mdgomareoba _ mkurnaloba _ gamosavali


Klinikuri kvlevebi ert jgufsi2
klinikuri kvlevebi erT jgufSi

uaryofiTi mxare:

Sedarebis jgufis ar arseboba. Sesabamisad, ver xerxdeba aqsperimentuli mkurnalobis efeqtebis diferencireba sxva cvladebis efeqtebisagan.


Klinikuri kvlevebi paralelur jgufebsi
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.


Klinikuri kvlevebi paralelur jgufebsi1
klinikuri kvlevebi paralelur jgufebSi

randomizacia

mkurnaloba a

Sedegebis Sefaseba

sakvlevi pirebi

mkurnaloba b


Klinikuri kvlevebi paralelur jgufebsi2
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.


Klinikuri kvlevebi paralelur jgufebsi3
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.


Klinikuri kvlevebi paralelur jgufebsi4
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.


Faqtoruli modeli
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.


Faqtoruli modeli1
faqtoruli modeli

mkurnaloba a

mkurnalobab

sakvlevi pirebi

Sefaseba

mkurnaloba a+b

placebo


Araertgvarovani modeli terapiis sewyveta withdrawal discontinuation design
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.


Araertgvarovani modeli
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).


Klinikuri kvlevebi jvaredin modelsi
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.


Klinikuri kvlevebi jvaredin modelsi1
klinikuri kvlevebi “jvaredin” modelSi

randomizacia

gamorecxvis periodit

gamorecxvis periodi

Rx A

Rx A

monacemTa analizi

sakvlevi pirebi

Rx B

Rx B

gamosavali

gamosavali


Klinikuri kvlevebi jvaredin modelsi2
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.


Klinikuri kvleva jvaredin modelsi
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.


Klinikuri fenotipis gansazrvra
klinikuri fenotipis gansazRvra

  • CarTva/gamoricxvis kriteriumebi gansazRvraven sakvlev klinikur fenotips.

  • CarTva/gamoricxvis kriteriumebi dakavSirebulia efeqturobisa da usafrTxoebis sakiTxvebTan.


Kvlevis sazrvrebi
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).


Ra ganapirobebs kvlevis warmatebit catarebas
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.



Sample size
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