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VI kursi
hendauti studentebisaTvis
Experimental
Studies: CAN be RCT
the gold standard Highest
internal
Observational validity at
studies: top
More prone to
bias and
confounding
MODELLI DI SPERIMENTAZIONE
r at o m r and o mi z i r ebu l i kvl evebi ?
STUDIO CLINICO CONTROLLATO RANDOMIZZATO
• kl i ni ku r i kvl evebi s aT vi s f aqt ebi s
mt ki c ebu l ebi s yvel az e maRal i
d o ne e.w.”
e.w.”o qr o s s t and ar t i ”
• s au keT es o t es t i a i nt er venc i i s
xar i s xi s Ses af as ebl ad
• pac i ent ebi d ayo f i l i a
eqs per i ment al u r d a s ako nt r o l o
j gu f ebad , r ac j gu f ebs xd i s
ko mpar abel u r s
G. Gori
• r and o mi z ac i a
• d abr maveba
• mku r nal o bi s d ani Snu l meT o d z e
d amo ki d ebu l i anal i z i
• Losses to follow-up
xar i s xo br i vad
r ao d eno br i vad (met a- a-anal i z i )
• z r d i s s t at i s t i ku r s i mZl avr es
• gamo avl ens kvl evaT a So r i s po t enc i u r Mmet a-
a-anal i z i
mo vl eni s xar i s xi
• mo vl eni s xar i s xi ( ER-RISK)pac i ent T a
pr o po r c i a i m j gu f Si r o mel Si c mo vl ena
aRi ni Sneba. as e magal i T ad , T u 100 pac i ent i d an
mo vl ena 27 aReni Sneba, maSi n mo vl eni s xar i s xi
0,27. s ako nt r o l o mo vl eni s xar i s xi (CER) d a
eqs per i ment u l i mo vl eni s xar i s xi (EER)
gamo i yeneba eqs per i ment u l d a s ako nt r o l o
j gu f ebSi am maCvenebl i s as axs nel ad
• EER = A/(A+B)%
• CER = C/(C+D)%
• Sans ebi (odds) d a al baT o bebi (risks) ar i s 20 on 100 20/100 = 0,20 20/80 = 0,25
al t er nat i u l i , magr am gans xvavebu l i meT o d ebi ,
r o ml ebi c gamo xat avs ko nkr et u l i mo vl eni s 50 on 100 50/100 = 0,50 50/50 = 1
ganvi T ar ebi s an ar ganvi T ar ebi s Ses aZl ebl o bas
• Sans T a T anaf ar d o ba (OR=A/B:C/D)-er T j gu f Si 80 on 100 80/100 = 0,80 80/20 = 4
mo vl eni s ganvi T ar ebi s Sans i s f ar d o ba meo r e
j gu f Si mi s i ganvi T ar ebi s Sans T an •Tu per i nat al u r i s i kvd i l o ba ganu vi Tar d a 100-d an 20 axal So bi l s , maSi n
per i nat al u r i s i kvd i l o bi s r i s ki i qneba = 0.20 = 20%.
• f ar d o bi T i r i s ki (RR=A/(A+B):C/(C+D)) an •per i nat al u r i s i kvd i l o bi s Sans i ar i s mkvd ar i axal So bi l ebi s Sef ar d eba
r i s kT a T anaf ar d o ba ar i s avad o bi s c o c xl ad d ar Ceni l axal So bi l Ta r i c xvTan (100-20 = 80) d a per i nat al u r i
T anaf ar d o ba pi r ebSi ,r o ml ebi c gani c d i an an ar s i kvd i l o bi s Sans i am SemTxvevaSi i qneba 20/80 = 0.25
gani c d i an r i s k-f aqt o r i s z emo qmed ebas .
slaidebi ##33-55
or konkretul sakiTxze moyvanilia epidemiologiuri gaTvlis magaliTebi, romlebis gvaZleven
kvlevis rezultatebis interpretirebis saSualebas. pirveli magaliTi exeba asimptomuri baqteriis
mkurnalobis efeqturobis dadgenas, xolo meore magaliTis sasualebiT davadgenT, Tu ramdenad
efeqturia oraluri kontraceptivebis gamoyeneba orsulobis Tavidan acilebis mizniT. meore agaliTi
ganxilvamde
s t at i s t i ki s mi mo xi l va
RR = EER/CER
d aavad eba
+ -
+ A B
mkur nal o ba
- C D
rogor ganvsazRvroT riski, namdvilad aris igi momatebuli? populacia, romelic iyo sakontrolo da
mkurnalobis mizniT iRebda raime gamosakvlev preparats aris jgufi (A+B), xolo meore jgufi, anu
sakontrolo aris (C+D) populacia, romelic ar Rebulobda mkurnalobas. droTa ganmavlobaSi
daavadeba pacientebs uviTardebaT orive jgufSi, eqsperimentul jgufSi es arian pacientebi (A),
xolo sakontrolo jgufSi – pacientebi(C).
d i agno s t i ku r i t es t i
l abo r at o r i u l i t es t ebi
• d i agno s t i ku r i t es t i -kl i ni ku r i d aavad eba d aavad eba
t es t i , r o mel i c t ar d eba d aavad ebi s (+) (-)
gamo vl eni s mi z ni T t es t i + a b a+b
• mi Rebu l i r ez u l t at ebi u nd a
i Zl eo d es kl i ni ku r ad s as ar gebl o WeSmar i t ad cr u
i nf o r mac i as d a gvexmar ebo d es d ad ebi T i d ad ebi T i
kl i ni ku r i gad awyvet i l ebi s mi RebaSi t es t i - c d c+d
• s kr i ni ngu l i t es t i - t ar d eba r i s k- cr u WeSmar i t ad
f aqt o r i s gamo vl eni s d a ar a
u ar yo f i T i u ar yo f i T i
d i agno s t i ki s mi z ni T
d i agno s t i ku r i t es t ebi
• c r u u ar yo f i T i maCvenebel i -t es t i s
r ez u l t at ebi u ar yo f i T i a, T u mc a
pac i ent i r eal u r ad d aavad ebu l i a
• c r u d ad ebi T i maCvenebel i – t es t i s
r ez u l t at ebi d ad ebi T i a, T u mc a
pac i ent i r eal u r ad d aavad ebu l i ar
ar i s
d ad ebi T i a b a+b
t es t i WeSmar i t i c r u d ad ebi T i yvel a vi s ac
d ad ebi T i d ad ebi T i
t es t i aqvs
u ar yo f i T i c d c+d
t es t i cr u WeSmar i t i yvel a vi s ac
u ar yo f i T i u ar yo f i T i u ar yo f i T i
t es t i aqvs WES
sul a+c b+d
yvel a yvel a
d aavad ebi s d aavad ebi s ar
mqo ne mqo ne
d ad ebi T i a b a+b
t es t i WESmar i t i - c r u -d ad ebi T i yvel a vi s ac
mgr Zno bel o bi s gaT vl i s magal i T i d ad ebi T i d ad ebi T i
t es t i aqvs
u ar yo f i T i c d c+d
d aavad eba d aavad eba t es t i cr u - WeSmar i t i - yvel a vi s ac
(+) (-) u ar yo f i T I u ar yo f i T i u ar yo f i T i
t es t i 27 14 t es t i aqvs
(+) sul a+c b+d
t es t i 3 56 yvel a yvel a
d aavad ebi s d aavad ebi s ar
(-)
mqo ne mqo ne
100
s pec i f i u r o ba = d/(b+d)
mgr Zno bel o ba = a/(a+c) WeSmar i t ad u ar yo f i T i t es t i -yvel as ar a aqvs d aavad eba.
mgr Zno bel o ba = 27/30 u ar yo f i T i t es t i s al baT o ba pac i ent T an, r o mel s ac
= 90% d aavad eba ar aqvs
s pec i f i u r o ba = d/(b+d)
s pec i f i u r o ba = 56/(56+14)= 56/70
= 80%
xSirad eqimebs ar gaaCniaT informacia imis Sesaxeb, Tu maT mier praqtikulad gamoyenebuli
diagnostikuri testebi ramdenad Seesabameba absoluturad sarwmuno standarts. xSirad testis
sarwmunoebis dasadgenad xdeba misi Sedegebis Sedareba sxva testTan, romelic ar aris
srulyofili, magram iTvleba ukeTesad, e.i. xdeba ori saeWvo testis Sedareba, romelTagan erTerTi
iTvleba standartad, rasac xSirad paradoqsTan mivyavarT, aRmoCndeba, rom Sesadarebeli testi
ufro zustia. diagnostikuri testebis rezultatebisa da daavadebis realurad arsebobas an
ararsebobibas Soris urTierTkavSiris dasdgenad bevrad ufro mniSvnelovania testis
mgrZnobelobis da specifiurobis codna. mgrZnobeloba, es aris daavadebis mqone populaciaSi im
pirTa wili, romelTac gaaCniaT diagnostikuri testis dadebiTi rezultati, mgrZnobiare tetsti
iSviaTad tovebs pacientebs, romelTac gaaCniaT daavadeba. specifiuroba es aris daavadebis ar
mqone populaciaSi im pirTa wili, romelTac aReniSnaT testis uaryofiTi rezultati. specifiuri testi,
rogorc wesi ar miakuTvnebs janmrTel pacients daavadebulebis jgufs. diagnostikuri testis
arCevisas eqimma yuradReba unda miaqcios mis mgrZnobelobasa da specifiurobas.
mgrZnobiare testi gamoyenebul unda iqnas, roca arsebobs saSiSi, magram gankurnebadi
daavadebis gaparvis riski, an diagnostikuri Ziebis adreul stadiebze Ziebis CarCoebis daviwroebis
mizniT. amgvarad, eqimebisaTvis mgrZnobiare testi gansakuTrebiT informatiulia, roca is iZleva
uaryofiT Sedegs. specifiuri testebis gamoyeneba saWiroa diagnozis dadasturebis mizniT.
maRalspecifiuri testi iSviaTad iZleva dadebiT rezultats daavadebis ararsebobis SemTxvevaSi,
e.i. iSviTad aris cru dadebiTi. maRalspecifiuri testis gamoyeneba gansakuTrebiT
mniSvnelovania, roca cru dadebiTma pasuxma SesaZlebelia paciants miayenos finansuri,
fizikuri an emocionaluri zarali. amgvarad, specifiuri testi diagnostikurad gansakuTrebiT
efeqturia, roca is iZleva dadebiT rezultats. sasurvelia, rom diagnostikuri testi erTdroulad iyos
maRalmgrZnobiarec da maRalspecifiuric, rac samwuxarod Znelad misaRwevia. kargi
skrininguli testic unda iyos maRalmgrZnobiare da maRalspecifiuri da skrininguli testis
mgrZnobeloba da specifiuroba iseve isazRvreba, rogorc diagnostikuri testis SemTxvevaSi.