Tbilisis saxelmwifo samedicino universitetis
alergologiisa da klinikuri imunologiis mimarTuleba
daviT Telias
klinikuri leqciebis cikli
klinikuri
kvlevebi
(nawili I)
Tbilisi
2009 w.
Tbilisis saxelmwifo samedicino universitetis
alergologiisa da klinikuri imunologiis mimarTuleba
daviT Telias klinikuri leqciebis cikli
klinikuri kvlevebi
naSromi gankuTvnilia
umaRlesi samedicino saswavleblebis
studentebisTvis, alergologebisTvis,
TerapevtebisTvis, pediatrebisTvis, ojaxisa da
zogadi praqtikis mqone eqimebisTvis.
naSromze yvela saavtoro ufleba ekuTvnis daviT Telias.
avtoris nebarTvis gareSe naSromis sruli an
nawilobrivi kopireba da gavrceleba akrZalulia.
Tbilisi, 2009 w.
2
daviT Telias klinikuri leqciebis cikli
klinikuri kvlevebi
klinikuri kvlevebi
nawili I
I. klinikur kvlevaTa zogadi
mimoxilva
bs!tf!cpct!lwmf!wjt!hbo!tywb!wf!cv!mj!qsp!up!lp!.
mf!cj-! psj!fo!uj!sf!cv!mj! lwmf!wjt! tywb!ebt!ywb! fmf!.
nfo!u{f-!lfs![pe;!
2*!tbl!wmfw!{f!npr!nf!ef!cfc!{f<!
3*!tbl!wmfw!{f!npr!nf!ef!cb!Ub!hb!ob!xj!mf!cb!{f<!
4*!tbl!wmfw!tv!cj!fr!uUb!sb!p!ef!op!cb!{f<!
5*!nlwmf!wbs!Ub!eb!tv!cj!fr!uUb!jo!gps!nj!sf!cv!mp!cb!.
{f<!
6*!lwmf!wb!Tj!bsb!sbo!ep!nj!{f!cvm!qjs!Ub!Dbs!Uwb!{f/
adamianis organizmze Catarebul biosamedicino kvlevas, romlis mizani medicinis aqtualuri sakiTxis Seswavlaa, lmj!oj!lv!sj!lwmf!wb ewodeba. kvalificirebulad Catarebuli klinikuri
kvleva maqsimalurad swrafi, usafrTxo da sarwmunoa. igi praqtikul medicinaSi inovaciebis
danergvis Tanamedrove meTodia. klinikuri kvlevebis saSualebiT SesaZlebelia pasuxi gaeces
mraval kiTxvas, maT Soris _ ramdenad mizanSeworandomizebuli kontrolirebadi
kvlevis (rkk) tipebi
nilia konkretuli samkurnalo an prevenciuli
saSualebis gamoyeneba ama Tu im daavadebis dros, 2*!tbl!wmfw!{f!npr!nf!ef!cfc!{f!psj!fo!uj!sf!cv!mj!sll
ramdenad efeqturia esa Tu es sadiagnostiko me- axsniTi, pragmatuli kvlevebi
efeqturobisa da efeqtianobis Semswavleli
Todi da sxva [3].
kvlevebi
sbo!ep!nj!{f!cvm! lpo!usp!mj!sf!cbe! lwmf!wfct
)sll* klinikur kvlevaTa Soris yvelaze maRali I, II da III fazis kvlevebi
sarwmunooba axasiaTebs da, Sesabamisad, gansakuT3*! tbl!wmfw! {f!npr!nf!ef!cb!Ub! hb!ob!xj!mf!cb!{f! psj!fo!.
rebul yuradRebas imsaxurebs. am tipis kvlevis
uj!sf!cv!mj!sll
arsi is aris, rom kvlevis protokolSi gaTva paraleluri kvlevebi
liswinebulia subieqtivizmis, tendenciebisa da jvaredin-gadafarviTi kvlevebi
Secdomebis maqsimaluri kontroli.
faqtoruli analiziT mimdinare kvlevebi
daviT Telias klinikuri leqciebis cikli
3
klinikuri kvlevebi
4*! tbl!wmfw! tv!cj!fr!uUb! sb!p!ef!op!cb!{f! psj!fo!uj!sf!.
cv!mj!lwmf!wf!cj
erTsubieqtiani da mravalsubieqtiani, megakvlevebi
fiqsirebuli raodenobis subieqtebze orientirebuli kvlevebi
subieqtebis Tanmimdevrul CarTvaze orientirebuli kvlevebi
5*I! ll-! psj!fo!uj!sf!cv!mj! {f!npr!nf!ef!cjt! Tf!tb!yfc
nlwmf!wb!sj!tb!eb!tbl!wmf!wj!tv!cj!fr!ujt!jo!gps!nj!.
sf!cv!mp!cb!{f
Ria kvleva
erTmagi brma kvleva
ormagi brma kvleva
sammagi da oTxmagi brma kvlevebi
5) kk ararandomizebuli individebisa da sakvlevi subieqtebis survilis gaTvaliswinebiT
Zelen-is (zelenis) protokoli
kohortuli kvleva
Wennberg-is (venbergis) protokoli
I. 1. sakvlev zemoqmedebaze
orientirebuli kvlevebi
maT ricxvs ekuTvnis axsniTi anu pragmatuli kvlevebi; efeqtis (anu efeqturobis), efeqtianobisa da ekvivalenturi kvlevebi; I, II, da III
fazis kvlevebi.
by!toj!Uj! bov! qsbh!nb!uv!mj! lwmf!wf!cjt! mizania,
dadgindes, ~muSaobs~ Tu ara zemoqmedeba. wesisamebr, aseTi kvlevebi imgvarad igegmeba, rom maTi
Sedegis mixedviT SesaZlebeli gaxdes e.w. sufTa
informaciis miReba zemoqmedebis Sesaxeb. am
dros sakvlevi jgufebis maqsimaluri Tvisebrivi (asaki, sqesi da a.S.) da raodenobrivi homogenizaciis mizniT metad mniSvnelovania adekvaturi saseleqcio kriteriumebis gamoyeneba [2].
axsniTi, pragmatuli kvlevebi igegmeba ara
mxolod imisTvis, rom gairkves, efeqturia Tu
ara zemoqmedeba, aramed imisTvisac, rom klinikasTan maqsimalurad miaxloebul pirobebSi aRiweros zemoqmedebiT ganpirobebuli yvela Sedegi _
kargic da cudic. amis misaRwevad ki saWiroa
sakvlevi subieqtebis SerCeva naklebad mkacri
saseleqcio kriteriumebiT. miuxedavad imisa, rom
4
axsniTi, pragmatuli kvlevebi TiTqmis komplementuri meTodebia, zogjer maTi elementebis Sexameba metad mniSvnelovania.
efeqti (efeqturoba) da
efeqtianoba
es ori cneba damwyeb mkvlevarebs zogjer
erTmaneTSi erevaT. fgfr!uj!)fgfr!uv!sp!cb* asaxavs,
ramdenad moqmedebs zemoqmedeba (erTgvari tavtologia am konteqstSi garduvalia) im subieqtebze, romelTac am tipis Careva daeniSnaT. igi
axsniTi xasiaTis kategoriaa. misgan gansxvavebiT,
fgfr!uj!b!op!cb niSnavs, ramdenad asruleben pacientebi mkvlevaris an eqimis daniSnulebas. maRali
komplaensi miiRweva, rodesac zemoqmedebas akontrolebs mkvlevari an damxmare personali, xolo Tu kontrols Tavad sakvlevi subieqti
axorcielebs, misi miRweva TiTqmis SeuZlebelia.
fgfr!uj!b!op!cjt kvleva fgfr!uv!sp!cjt kvlevasTan
SedarebiT martivia, Tundac imitom, rom efeqtianobis kvlevisas seleqciis kriteriumebis SerCeva nakleb simkacres moiTxovs. efeqtianobis
Seswavla, wesisamebr, efeqturobis Seswavlis Semdeg xorcieldeba [5].
zogjer kvlevebi imgvarad igegmeba, rom ar iTvaliswinebs ori an ramdenime zemoqmedebis efeqtianobasa da efeqturobas Soris gansxvavebis dadgenas. am
tipis kvlevebs fl!wj!wb!mfo!uvs!lwmf!wfct uwodeben.
I, II
da III fazis kvlevebi
axali preparatis moqmedebis Seswavlis
mizniT tardeba I, II da III fazis kvlevebi. I da
II fazis kvlevebi, wesisamebr, ar aris randomizebuli [8].
I fazis kvleva pirveli safexuris kvlevaa,
romelic tardeba adamianebze axali preparatis
moqmedebis Seswavlis mizniT. is xorcieldeba
mxolod mas Semdeg, rac cxovelebze daadgenen
preparatis usafrTxoebasa da efeqturobas. im
SemTxvevaSi, Tu mkvlevarma praqtikulad araferi
icis axali preparatis adamianis organizmze zemoqmedebis Sesaxeb, kvleva usafrTxoebaze unda
daviT Telias klinikuri leqciebis cikli
klinikuri kvlevebi
iyos orientirebuli. am dros ganisazRvreba axali preparatis dozirebac, raTa gamoiricxos seriozuli gverdiTi moqmedeba. agreTve maxvildeba yuradReba mis metabolizmze adamianis organizmSi.
I fazis kvlevebi, wesisamebr, mcire raodenobis janmrTel moxalise pirebze xorcieldeba. kvlevaSi xSirad monawileoben Tavad mkvlevarebi, farmacevtuli kompaniis warmomadgenlebi
da sxv., aseve _ inkurabeluri seniT (magaliTad,
kiboTi an SidsiT) daavadebulni [10].
amrigad, kvlevis xsenebul etapze dgindeba
wamlis tolerantoba, maqsimaluri tolerantuli doza, preparatis toqsikuroba, gverdiTi
efeqtebi, garda amisa Seiswavleba farmakokinetika (wamalze organizmis zemoqmedeba _ absorbcia,
distribucia, metabolizmi, eliminacia) da farmakodinamika (wamlis moqmedeba organizmze) [1].
preparatis usafrTxoebis dadgenis Semdeg
mkvlevari II fazis kvlevas iwyebs. am kvlevebis
dros gamosacdeli preparati eZleva konkretuli daavadebis mqone pacientTa mcire jgufs (magaliTad, 20 kacs), romelic aucileblad homogenur populacias unda warmoadgendes. II fazis
kvlevis mizania, dadgindes preparatis sxvadasxva
dozis efeqturoba da miRebis sixSire. garda
amisa, kvlevaSi kvlavac moiZieba damatebiTi informacia preparatis usafrTxoebis Sesaxeb da
SeiZleba, ufro Rrmad iqnes Seswavlili misi
farmakokinetika da farmakodinamika [11].
III fazis kvleva igegmeba, rodesac II fazis
kvlevaSi dasturdeba preparatis efeqti (efeqturoba), usafrTxoeba da SeirCeva optimaluri
doza. es kvleva, rogorc wesi, aris SerCeuli
dozis efeqturobis kvleva, vinaidan am dros axali preparatis moqmedebas ukve kargad cnobili
da aprobirebuli preparatebis efeqtebs adareben. III fazis kvleva, rogorc wesi, rkk-a da mraval subieqtze tardeba.
arsebobs, agreTve, damatebiTi _ IV fazis
kvlevebi. maTi mizani axali preparatis gverdiTi efeqtebis monitoringia, xorcieldeba mravalricxovan populaciaze da, cxadia, mas Semdeg,
rac preparats warmoebasa da marketingSi CauSveben. am tipis kvlevebs postmarketul kvlevebsac uwodeben [2].
I. 2. sakvlev zemoqmedebaTa ganawilebaze orientirebuli kvlevebi
maT ricxvs miakuTvneben paralelur, jvredin-gadafarviT da faqtorul kvlevebs.
paraleluri kvlevebi
rkk-is umravlesoba paraleluria. am tipis
kvlevebis dros sakvlev subieqtTa TiToeuli
jgufi ganicdis mxolod erT zemoqmedebas. magaliTad, axali saanesTezio saSualebis paraleluri meTodiT gamokvlevisTvis subieqtTa erT
jgufs aqtiur gamosakvlev preparats aZleven,
xolo meores _ placebos. monacemTa Sedareba
xdeba sakvlev jgufebs Soris (jgufTa Soris
kvleva).
jvaredin-gadafarviTi meTodi
rkk jvaredini-gadafarviTi tipisaa, rodesac kvlevaSi monawile yoveli subieqti Tanmimdevrulad ganicdis yvela sakvlev zemoqmedebas.
zemoqmedebaTa Tanmimdevroba randomulad _ SemTxveviT ganisazRvreba. am tipis protokoli iTvaliswinebs TviT sakvlev jgufSi subieqtebis
Sedarebas da, amdenad, TiToeuli subieqti Tavad
warmoadgens kontorols. aqedan gamomdinare, jvaredin-gadafarviTi meTodi, statistikuri da
klinikuri sarwmunoobis TvalsazrisiT, SedarebiT mcire raodenobis sakvlev subieqts moiTxovs, vidre paraleluri kvlevis dros.
drois im monakveTs, romlis ganmavlobaSic
xorcieldeba zemoqmedebani da Seiswavleba maTi
efeqtebi, qf!sj!p!ej ewodeba. jvaredin-gadafarviTi
meTodi or periods moicavs. pirvelSi jer aqtiuri preparati iniSneba, Semdeg ki placebo, an
piriqiT _ jer placebo, xolo Semdeg _ aqtiuri preparati. kvlevis es meTodi yovelTvis ar
aris misaRebi da gamarTlebuli.
faqtoruli kvlevis meTodi
rkk-s faqtoruli ewodeba, rodesac ori an
meti zemoqmedeba Seiswavleba ara mxolod calcalke, aramed kombinaciaSi da kontrolTan mimarTebiT. magaliTad, kiboTi daavadebul pacien-
daviT Telias klinikuri leqciebis cikli
5
klinikuri kvlevebi
tebSi opioiduri tipis da anTebis sawinaaRmdego arasteroiduli preparatis (naproqseni) moqmedebis faqtoruli kvlevis meTodiT Seswavla
niSnavs, rom pacientebi randomulad Semdeggvarad
unda ganawildnen: nawili miiRebs opioidur preparats, nawili _ naproqsens, nawili _ maT kombinacias, nawili ki placebos. amdenad, es protokoli iZleva SesaZleblobas, sakvlevi preparatebi Seedaros rogorc kontrols, ise erTmaneTs
da, amasTanave, Sefasdes maTi Tanamoqmedebis efeqti [2].
I. 4. mkvlevarisa da sakvlevi subieqtis informirebulobaze orientirebuli kvleva
kvlevaTa warmoebisa da maTi Sedegebis analizis dros Secdomebis Tavidan acilebisTvis,
garda randomizebisa, arsebobs sxva meTodologiuri strategiac. am strategias csnb! nje!hp!nb
)nbt!lj!sf!cjt!nf!Up!ej* ewodeba. misi mTavari mizania, mkvlevarma kvlevaSi CarTul pirs (pirebs)
ar miawodos informacia zemoqmedebaTa ganxorcielebisa da maTi arsis Sesaxeb. nbt!lj!sf!cb amcirebs subieqtur, dakvirvebebTan an SefasebebTan
I. 3. sakvlev subieqtTa
raodenobaze orientirebuli kvleva
rkk-Si SeiZleba monawileoba miiiRos erTma an ramdenime aTasma sakvlevma subieqtma. maTi ricxovnoba SeiZleba iyos fiqsirebulic da
cvladic. kvlevaSi SeiZleba CaerTos erTi an
ramdenime centri (klinika) (multicentruli
kvleva). kvleva SeiZleba erT subieqtsac Cautardes. am SemTxvevaSi mas individualuri, e.w.
n=1 lwmf!wb ewodeba.
fiqsirebuli moculobis
kvlevebi
aseTi kvlevebis dros mkvlevari statistikuri meTodebiT winaswar gansazRvravs gamosakvlev pirTa raodenobas (subieqtTa reprezentatiuli amonakrebi _ sample size). am tipis
kvlevisas sagrZnoblad izrdeba kvlevis sizuste.
dakavSirebul SecdomaTa risks.
rkk-Si maskireba sxvadasxva doneze xorcieldeba: kvlevaSi monawileebis, mkvlevarebis, zemoqmedebaTa uSualod ganmxorcielebeli klinicistebis, pacientebis momvleli personalis,
mkvlevarebisa, romlebic afaseben Sedegobriv
cvladebs, pirebisa, romlebic aanalizeben monacemebs, kvlevis Sedegebis redaqtorebis da a.S.,
Tumca xSirad isini erTi da igive adamianebi
arian. maskireba SeiZleba iyos fs!Unb!hj!csnb-!ps!.
nb!hj!csnb-!tbn!nb!hj!csnb!eb!pUy!nb!hj!csnb. Tu maskireba ar gamoiyeneba, maSin kvlevas Sjb!fxp!ef!.
cb/ Ria rkk aris kvleva, romlis dros kvlevaSi
CarTuli yvela piri informirebulia gamoyenebul zemoqmedebaTa da adresatTa Sesaxeb. am saxis kvlevebi upiratesad qirurgiaSi gamoiyeneba.
I. 5. ararandomizebul
subieqtebsa da sakvlevi
pirebis survilze
orientirebuli kvlevebi
Tanmimdevruli kvlevebi
zogjer rkk-s ganxorcieleba rTuldeba, vinaidan
sakvlevi pirebi uars amboben kvlevaSi moTanmimdevruli
kvlevebi
paraleluri
kvlevebia, romlebSic sakvlevi subieqtebis rao- nawilebaze an ar surT maTTvis SerCeuli zemoqdenoba winaswar ar aris gansazRvruli. mkvleva- medebisa Tu placebos miReba. zogjer pacients
surs icodes, romel zemoqmedebas iRebs an motiri kvlevaSi TanmimdevrobiT rTavs sakvlev suvirebulia konkretuli zemoqmedebis miRebisadmi.
bieqtebs, vidre ar dafiqsirdeba romelime sakam SemTxvevaSi sakvlev pirebSi Sedegobrivi
vlevi zemoqmedebis efeqturoba an ar dadginde- cvladebi sxvagvarad Sefasdeba. sakvlev pirTa
ba zemoqmedebis uefeqtoba.
survilis gaTvaliswinebiT Catarebul rkk-s
Tanmimdevruli kvleva resursebis xarjvis qsf!gf!sfo!dj!v!mj!lwmf!wf!cj ewodeba. isini sami tioptimizebis saSualebas iZleva, Tumca, amave dros, pisaa: {f!mf!ojt-!wfo!cfs!hjt!eb!lp!ips!uv!mj!lwmf.
sagrZnoblad rTuldeba Sedegobrivi cvladebis
wb/
gazomva da sizustec SedarebiT naklebia.
6
daviT Telias klinikuri leqciebis cikli
klinikuri kvlevebi
zelenis kvleva
zelenis protokolis upiratesoba is
am protokolis gamoyenebisas kvlevaSi Ca- aris, rom kvlevaSi TiTqmis yvela SesarCevi pisarTavi individebis randomizeba manamde xdeba, ri monawileobs, kvleva ki iZleva pacientebisvidre isini standartuli an eqsperimentuli ze- Tvis SeTavazebuli eqsperimentuli zemoqmedebis
moqmedebis miRebaze daTanxmdebian. amis Semdeg sa- realuri efeqtis gamokvlevis saSualebas. meTokontrolo jgufSi moxveedrili pirebi miiReben dis mTavar naklad ki miiCneva, rom kvleva Ria
standartul preparats, magram maT ar acnobeben, tipisaa da Tu sakvlev subieqtTa didma umravrom isini kvlevaSi monawileoben, eqsperimentul lesobam standartuli zemoqmedeba airCia, misi
jgufSi moxvedril pirebs ki sTavazoben sakvle- sarwmunooba sagrZnoblad mcirdeba.
vi preparatis miRebas da kvlevaSi CarTvas. Tu
zelenis dizainis eTikuri xarvezebis (pasubieqti uars ityvis kvlevaSi monawileobaze cientma ar icis, rom iRebs standartul prepa(eqsperimentuli preparatis miRebaze), maSin igi rats) Tavidan acileba SeiZleba meTodis modimiiRebs standartul preparats, magram Sedegebis ficirebiT, magaliTad, SerCeul pacientebs erTi
analizis dros es monacemebi ganixileba, rogorc sakvlevi jgufidan meoreSi gadasvlas SesTavazeeqsperimentuli preparatis miRebis Sedegi.
ben (sur. 1).
sur.#1
zelins kvlevis sqematuri gamosaxuleba
daviT Telias klinikuri leqciebis cikli
7
klinikuri kvlevebi
kohortuli kvleva
farTo kohortuli kvlevis dros sakvlev
subieqtebs akvirdebian gansazRvruli xnis ganmavlobaSi, ganurCevlad maTi randomizebis statusisa. am tipis kvlevis dros Tu piri Tanaxmaa kvlevaSi monawileobaze, xdeba misi randomizeba erT-erT sakvlev jgufSi. Tu piri ar eqvemdebareba randomizebas (vinaidan ganwyobilia
romelime konkretuli sakvlevi preparatis miRebisadmi), maSin igi iRebs sasurvel zemoqmedebas da amrigad kohortul kvlevaSi erTveba. amis
Semdgom sakvlev jgufebSi analizdeba Sedegobrivi cvladebi. am tipis kvleva misaRebia maSin,
rodesac SesarCev subieqtebSi aris ganwyoba konkretuli zemoqmedebis miRebisadmi, ris gamoc
isini randomizebas ar eqvemdebarebian. masSi monawileoben SedarebiT mcire raodenobis subieqtebi. am kvlevis mTavari nakli is aris, rom Sedegobriv cvladebs Soris sxvaoba SeiZleba aixsnas subieqtebis randomul kvlevaSi CarTva-arCarTvis surviliT (sur. 2).
venbergis kvleva
am tipis kvlevis dros SesarCevi subieqtebi randomulad nawildebian or jgufSi. pirvel
jgufSi moxvedrili pacientebi TviTon irCeven
preparats (standartuls an sacdels), xolo meore jgufSi moxvedrilebi kidev erTxel gaivlian randomizacias, ris Sedegadac SemTxveviT ganawildebian sakvlev da sakontrolo jgufebSi.
kvlevis dasasruls erTmaneTs Seedareba orive
jgufis Sedegobrivi cvladebi. amdenad, SesaZloa,
Sefasdes individis mier gakeTebuli arCevanis
(zemoqmedebis) gavlena Sedegobriv cvladze (sur. 3).
preferenciuli kvlevebi naklebaqtiurad
da konkretuli daniSnulebisamebr gamoiyeneba.
amgvarad, zogadad mimovixileT klinikuri
kvlevis tipebi, rasac arsebiTi mniSvneloba aqvs
am kvlevaTa warmoebis codnis sistematizebisTvis, samecniero miznis adekvaturi klinikuri
kvlevis tipis SerCevis, misi dagegmvis, efeqturi
ganxorcielebisa da Sedegebis interpretirebisTvis. swored am sakiTxebis detalur ganxilvas
eZRvneba momdevno Tavebi.
sur.#2
kohortuli kvlevis sqematuri gamosaxuleba
8
daviT Telias klinikuri leqciebis cikli
klinikuri kvlevebi
sur.#3
venbergis kvlevis sqematuri gamosaxuleba
II. rogor daviwyoT kvleva
II. 1. kvlevis dagegmva
Tanamedrove samedicino mecnieruli kvlevis meTodebi uzrunvelyofs am kvlevebis maqsimalurad obieqtur Catarebas da, aqedan gamomdinare, maT sarwmuno Sedegs. isini, upirveles yovlisa, miznad isaxavs SemTxveviTi Secdomebis, subieqturi Sefasebebisa da tendenciebis Tavidan
acilebas, sadac es SesaZlebelia, xolo sadac ara
_ met-naklebad zustad gansazRvravs mosalodnel SecdomaTa albaTobas da, maSasadame, Sedegebis sarwmunoobas.
yvela samecniero kvlevas, rogorc observaciuls, ise eqsperimentuls, kvlevis gegmaprotokoli udevs safuZvlad. rac ufro daxvewilia es protokoli, miT ufro didia maRali
xarisxis kvlevis Catarebis perspeqtiva [12].
mecnieruli kvlevis dagegmvis dros mniSvnelovania ori sakiTxi:
rogori struqturis unda iyos kvleva (ra
aris gasakeTebeli);
rogor unda warimarTos (Sesruldes) igi.
lwmf!wjt! tusvr!uv!sb aisaxeba mis gegmaprotokolSi, romelic moicavs ramdenime elements. esenia:
kvlevis ZiriTadi sakiTxi;
protokolis tipi;
sakvlevi subieqti;
cvladebi da parametrebi;
sakvlevi masalis reprezentatiuloba Tvisebrivi da raodenobrivi TvalsazrisiT da sxva.
tusvr!uv!sv!mj!fmf!nfo!uf!cj!jtf!vo!eb!hb!oj!.
tb{S!wspt-!spn!qsp!fr!uj!hbo!yps!dj!fm!eft!nbr!tj!nb!.
mv!sbe!txsb!gbe-!be!wj!mbe!eb!jb!gbe/
daviT Telias klinikuri leqciebis cikli
9
klinikuri kvlevebi
lwmf!wjt! xbs!nbs!Uwb (mimdinareoba) kvleva
fasdeba saboloo SedegiT, kvlevis calkeuli
etapebiT da am etapebze miRebuli daskvnebiT.
kvlevis mecnieruli Rirebuleba miT ufro maRalia, rac ufro metad Seesabameba kvleviT dadgenili kanonzomierebebi realurad arsebuls.
kvleviT
dadgenili kanonzomiereba ori
saxisaa:
Sida kanonzomiereba (romelic vlindeba konkretuli sakvlevi masalis Seswavlisas);
gare kanonzomiereba (Sida kanonzomierebis
ganzogadebis SesaZlebloba mTel populaciaze).
magaliTad: sportis romelime saxeobis mimdevar 200 sportsmenSi arteriuli wnevis Taviseburebis gamovlena Tj!eb!lb!opo!{p!nj!f!sf!cb!b-!am saxeobis mimdevar yvela sportsmenze aRniSnuli
kanonzomierebis ganzogadebis SesaZleblobas ki
hb!sf!lb!opo!{p!nj!fs
! f!cbt uwodeben.
nfd!oj!f!sjt!vn!Ubw!sf!tj!nj!{b!ojb!Tj!eb!eb!hb!sf
lb!opo!{p!nj!f!sf!cb!Ub!ebe!hf!ob!eb!bn!espt!hb!npw!mf!.
ojm! Tfd!ep!nb!Ub! bm!cb!Up!cjt! nj!oj!nv!nbn!ef! ebz!wb!ob
bo-!Uv!Tf!tb[!mpb-!Ub!wj!ebo!bdj!mf!cb/
aRniSnuli Secdomebi SesaZloa ori saxis
iyos:
SemTxveviTi;
sistematikuri.
psj!wf!nbU!hb!oj!vTv!b!mpe!npr!nf!efct!nj!Sf!cv!.
mj!Tf!ef!hf!cjt!tbs!xnv!op!p!cb!{f/
kvlevis struqtura da misi elementebi
unda aisaxebodes kvlevis gegmaSi (protokolSi).
gegmis Seqmna aucilebelia, raTa mkvlevarma logikurad da efeqturad warmoaCinos kvlevis yvela met-naklebad mniSvnelovani elementi.
kvlevis standartuli gegma (protokoli)
warmodgenilia #1 cxrilSi.
mokled ganvixiloT cxrilSi warmodgenili elementebi:
lwmf!wjt!nj!{b!oj/ kvlevis mizani unda iyos
miRwevadi da warmoadgendes medicinis ama Tu im
aqtualuri, gadauWreli an nawilobriv gadauWreli problemis gadawyvetis mcdelobas. kvlevis sakiTxis anu miznis formulireba xSirad
zogadi xasiaTisaa da misi dakonkreteba Semdgom
xdeba. magaliTad, SesaZloa, kvlevis mizani iyos
imis dadgena, uwyoben Tu ara xels narkomanebi
mosaxleobaSi virusuli hepatitis gavrcelebas.
10
rogorc vxedavT, kiTxva zogadi xasiaTisaa. mas
mosdevs sakiTxTa dakonkreteba, rac ramdenime
specifikur kiTxvaSi aisaxeba. magaliTad, mosaxleobis ra nawilia inficirebuli hepatitiT, romeli riskfaqtorebia mniSvnelovani hepatitis
gavrcelebis TvalsazrisiT da a.S.
tb!ljUy!jt!nojT!wof!mp!cb/ kvlevis es elementi
unda asaxavdes, ra aris cnobili mocemuli sakiTxis Sesaxeb, riTia is mniSvnelovani, rogori
Sedegebia mosalodneli, rogoria sxva avtorebis
mier miRebuli Sedegebi da maTi interpretaci,
rogori Teoriuli da praqtikuli mniSvneloba
eqneba kvlevas.
lwmf!wjt!hfh!nb/ kvlevis gegma, rogorc wesi,
kompleqsuria da SesaZloa, sxvadasxva tipis an
xasiaTisa iyos. kvlevis dagegmvis dros umTavres amocanas warmoadgens kvlevis xasiaTis swori gansazRvra. mag.: kvleva SesaZloa iyos pc!tfs!.
wb!dj!vm
! j (rodesac mxolod akvirdebian da faqtebs afiqsireben) an fr!tqf!sj!nfo!uv!mj (rodesac
mkvlevari zemoqmedebas axdens kvlevis subieqtze da swavlobs aRniSnuli zemoqmedebis Sedegebs).
kvlevis observaciuli meTodi, Tavis mxriv,
SesaZloa iyos lspt!.tfr!dj!v!sj (cross-sectional),
rodesac dakvirveba xdeba mxolod erTjeradad,
an hs[fm!wb!ej!b!oj (longitudinal), rodesac dakvirveba garkveuli xnis ganmavlobaSi mimdinareobs.
kvlevis dagegmvis momdevno elementia misi
Catarebis esp!j!Uj! nb!yb!tj!b!Ufc!mf!cj/ Tu kvlevis
dros Seiswavlian awmyosa da warsulSi momxdar
movlenebs, maSin kvleva SinaarsiT retrospeqciulia, xolo im movlenebis kvlevas, romlebic
momavalSia mosalodneli, prospeqciuli ewodeba.
lwmf!wjt! nf!Up!ejt! Tfs!Df!wb unda moxdes
kvlevis miznis Sesabamisad. amasTanave, unda gvaxsovdes, rom arc erT xsenebul meTods ar gaaCnia mudmivi upiratesoba sxvasTan SedarebiT. es
upiratesoba mxolod konkretul situaciaSi unda gamovlindes. magaliTad, randomizebuli kvlevis meTodi klinikuri kvlevis ~oqros standartad~ iTvleba. magram arsebobs situaciebi, rodesac observaciuli kvleva ufro misaRebia, vidre randomizebuli.
daviT Telias klinikuri leqciebis cikli
sfu!spt!qfr!dj!vm!.Tf!eb!sf!cj!Uj! )tbd!efm!.tb!.
klinikuri kvlevebi
cxrili #1
gripis sawinaaRmdego vaqcinacia
kvlevis elementi
elementis Sinaarsi
I. kvlevis mizani
ra sakiTxs eZRvneba kvleva?
II. sakiTxis mniSvneloba
ratom aris sakiTxi mniSvnelovani?
III. kvlevis proeqti (kvlevis gegma)
1. ganxorcielebis dro
2. protokolis tipi
rodis da rogor ganxorcieldeba kvleva?
IV. kvlevis subieqti
1. SerGevis meTodebi (randomizacia da
misi saxeebi)
2. SerGevis kriteriumebi
3. gamoricxvis kriteriumebi
vin iqneba kvlevis sagani da rogor moxdeba maTi
seleqcia?
V. cvladebi
1. mizezobrivi
2. Sedegobrivi
ra saxis gazomvebi Gatardeba
VI. statistikuri damuSa-veba
1. hipoTezis formireba
2. amonakrebi sididis gansazRvra.
3. aRwerilobiTi statistika
4. analitikuri statistika
ra moculobis masalas moicavs kvleva (aris Tu ara
is reprezentatuli) da rogor moxdeba monacemebis
damuSaveba.
lpo!usp!mp* kvlevebi dabali Rirebulebis gamo
gansakuTrebiT popularulia, Tumca mxolod am
parametriT kvlevis tipis SerCeva, rasakvirvelia,
ar aris gamarTlebuli. mniSvneloba aqvs agreTve sxvadasxva tipis kvlevis Tanmimdevrul gamoyenebas. sawyis etapze ukeTesia SerCeul iqnes
SedarebiT martivi kvleva. magaliTad, Ria tipis
observaciuli kvleva, romelsac xSirad bS!xf!sj!.
mp!cj!Uj ewodeba. aseTi kvlevis magaliTs warmoadgens romelime daavadebis gavrcelebis an misi
maxasiaTeblebis Seswavla populaciaSi (magaliTad, rogoria Sidsis virusis antisxeulebis
koncentracia narkomanebSi).
aRwerilobiT kvlevebs xSirad mosdevs an
paralelurad mihyveba bob!mj!{v!sj! lwmf!wf!cj! `
lwmf!wf!cj-! sp!nfm!Ub! tb!Tv!b!mf!cj!Ubd! hb!b!ob!mj{!ef!cb
btp!dj!bd
! j!fc! jt! bs!tf!cp!cb! bo! bsbs!tf!cp!cb! dwmb!efct
Tp!sjt!eb!xbs!npD!oef!cb!nj!{f!{j!tb!eb!Tf!ef!hjt!vs!.
Uj!fs!Ueb!np!lj!ef!cv!mf!cb!)nb!hb!mj!Ube-!nj!p!lbs!ej!v!njt
jo!gbs!rujt!sjt!lgbr!up!sf!cjt!hb!npw!mf!ob*/
saboloo da, maSasadame, ufro rTul kvlevebs miekuTvneba eqsperimentuli kvlevebi, romlebic saSualebas iZleva, dadgindes an Seswavlil iqnes mkvlevris mier ganxorcielebuli zemoqmedebiT ganpirobebuli Sedegi. magaliTad,
daviT Telias klinikuri leqciebis cikli
11
klinikuri kvlevebi
ramdenad moqmedebs mosaxleobaSi infeqciur sneulebaTa gavrcelebaze specialuri saganmanaTleblo programebis gamoyeneba. cxadia, eqsperimentuli kvlevebi ufro Zviria da maTi ganxorcieleba SedarebiT Znelia. samagierod, kvlevis
mizani am dros ufro konkretulia.
zogierTi kvleva ver Tavsdeba verc erTi
tipis CarCoebSi da romelime maTganisTvis maTi
erTmniSvnelovnad mikuTvneba sakmaod ZneTlia.
miuxedavad amisa, mizanSewonilia, miaxloebiT mainc ganisazRvros kvlevis tipi da es moxdes
rac SeiZleba martivad, magaliTad, erTi winadadebiT. moviyvanoT konkretuli magaliTi: vTqvaT,
kvleva jvaredin-seqciuri xasiaTisaa da mis mizans warmoadgens Sidsis virusis antisxeulebis
gamovlenis sixSiris Seswavla qalaqis infeqciur sneulebaTa klinikaSi. kvleva SesaZloa gagrZeldes prospeqtuli kohortuli meTodiT,
Sidsis antisxeulebis gamovlenis mizniT klinikaSi moTavsebul im pirebSi, romelTac antisxeulebi pirvel etapze ar aRmoaCndaT.
kvlevis subieqti
subieqtis arCevis dros saWiroa:
hb!oj!tb{S!wspt! tv!cj!fr!ujt! Tfs!Df!wjt! lsj!uf!.
sj!v!nf!cj- e.i. romeli avadmyofebi unda SeirCes
da rogor, raTa isini maqsimalurad pasuxobdnen
kvlevis mizans. aseTi SerCevis procesi sakmaod
rTulia da gulisxmobs winaswar gansazRvruli
kriteriumebis safuZvelze avadmyofTa qvejgufebidan Sesaferisi subieqtebis SerCevas (kvlevis
am elementis Sesaxeb dawvrilebiTi informacia
warmodgenili iqneba momdevno TavebSi) [7].
Tfs!Df!vm!jr!oft!tbl!wmf!wj!tv!cj!fr!ujt!nb!yb!tj!.
b!Ufc!mf!cj- rac kvlevis aranakleb mniSvnelovani
elementia. aRwerilobiTi kvlevis dros xdeba
romelime SerCeuli maxasiaTeblis erTjeradi
Seswavla, analizuri kvlevis dros ki saWiroa
gaanalizdes urTierTdamokidebuleba or an ramdenime maxasiaTebels Soris da amrigad gakeTdes
saTanado daskvna mizez-Sedegobrivi asociaciis
arsebobis an ararsebobis Sesaxeb.
12
cvladebi
tv!cj!fr!ujt!ps!nb!yb!tj!b!Uf!cfmt!Tp!sjt!btp!dj!.
b!dj!jt!bs!tf!cp!cjt!Tfn!Uywf!wb!Tj!fsU!nbU!hbot-!sp!nf!.
mjd!vt!xsfct!nf!p!sft-!nj!{f!{pc!sj!wj!)qsf!ejr!uv!mj*
nb!yb!tj!b!Uf!cf!mj!bo!dwmb!ej!fxp!ef!cb-!yp!mp!nf!p!sft
.!Tf!ef!hpc!sj!wj/
observaciul kvlevaTa umravlesobas mravali mizezobrivi maxasiaTeblis (magaliTad, sxvadasxva diagnostikuri an prognozuli Rirebulebis maxasiaTeblebis) arseboba axasiaTebs. Sidsis SemTxvevaSi mizezobriv maxasiaTebels (prediqtors) warmoadgens socialur-ekonomikuri
statusi, asaki, sqesi, sqesobrivi orientacia da
sxva, Sedegobrivs ki _ Sidsis simptomatika da
antivirusuli antisxeulebis maRali titri.
eqsperimentuli kvlevebis dros mizezobrivi maxasiaTebelia mkvlevris mier avadmyofze
ganxorcielebuli zemoqmedeba (magaliTad, saganmanaTleblo programis zemoqmedeba narkomanze).
am kvlevis dros eqsperimentatori swavlobs aRniSnuli mizezobrivi maxasiaTeblis zegavlenas
Sedegobriv maxasiaTebelze (magaliTad, Sidsis
antisxeulebis gamovlenis sixSireze), Tumca amave dros unda iTvaliswinebdes sxva mizezobrivi
maxasiaTeblebis (kofaqtorebis) SesaZlo zegavlenas (magaliTad, socialur-ekonomikuri statusi SesaZloa gavlenas axdendes Sedegobriv maxasiaTebelze).
statistikuri damuSaveba
kvlevis momdevno etapia monacemebis statistikuri analizi. bob!mj!{v!sj! eb! fr!tqf!sj!nfo!.
uv!mj! lwmf!wf!cjt! espt! np!ob!df!nf!cj! ov!mp!wbo!.bm!.
ufs!ob!uj!vm
! j!ij!qp!Uf!{jt!uft!uj!sf!cjt!tb!Tv!b!mf!cjU
nv!Tbw!ef!cb/!am dros mkvlevari winaswar gansazRvravs erT mTavar hipoTezas, magaliTad, nulovans
(nulovani hipoTeza gulisxmobs, rom mizezobriv
da Sedegobriv maxasiaTeblebs Soris asociacia
ar aris, alternatiuli ki sapirispiros varaudobs). ij!qp!Uf!{b-!Ub!wjt!nysjw-!xbs!np!be!hfot!lwmf!.
wb!Tj!ebt!nv!mj!ljUy!wjt!qb!tv!yjt!fs!U.fsU!Tf!tb[!mp
wfs!tj!bt- romlis marTebuloba sxvadasxva statistikuri meTodiT dgindeba. magaliTad, mkvlevari empiriulad uSvebs, rom im narkomanebs, romlebic inieqciis win nemss spirtiani tamponiT
daviT Telias klinikuri leqciebis cikli
klinikuri kvlevebi
amuSaveben, ufro iSviaTad uvlindebaT Sidsis antisxeulebi, vidre maT, vinc spirtiT daumuSavebel nemss iyenebs [8].
aRwerilobiTi kvlevebi ar moiTxovs hipoTezis wamoyenebas da mis testirebas, vinaidan am
kvlevebis mizania, aRiweros ama Tu im maxasiaTeblis ganawileba da ara asociaciebis gamovlena
maT Soris.
yvela kvlevis aucilebel komponents warmoadgens Tvisebrivad da raodenobrivad Sesatyvisi reprezentatiuli gamosakvlevi masalis
(subieqtebis) gansazRvra. Tu kvlevis dros saqme exeba hipoTezis testirebas, maSin Sesadarebel
jgufebSi sakvlev subieqtTa raodenoba (amonakrebi) unda ganisazRvros winaswar, jgufebs Soris empiriulad daSvebuli mosalodneli gansxvavebis gaTvaliswinebiT, rasakvirvelia, sakvlevi subieqtis romelime maxasiaTeblis mixedviT.
aRwerilobiTi kvlevebis dros ki amonakrebi sididis gansazRvra moiTxovs subieqtTa im raodenobas, romelic aucilebelia sarwmuno aRwerilobiTi statistikis Casatareblad (saSualo,
proporciebi da sxva).
II. 2. rogor SevafasoT
kvlevis gegma
kvlevis saboloo Sedegis ganxilva saSualebas iZleva, Sefasdes kvlevis proeqti (gegmaprotokoli). am dros yuradReba unda mieqces
kvlevaSi warmoCenil or ZiriTad Sedegs:
Tfs!Df!vm! tbl!wmfw! nb!tb!mb!{f! hb!npw!mf!ojm! lb!.
opo!{p!nj!f!sf!cbt-!bov!Tj!eb!lb!opo!{p!nj!fs
! f!cbt<
hb!npw!mf!oj!mj! lb!opo!{p!nj!f!sf!cjt! tb!fs!Up! qp!qv!.
mb!dj!b!{f!hbo!{p!hb!ef!cjt!nbs!Uf!cv!mp!cbt/
kvlevis mimdinareobis procesSi mkvlevari
gamudmebiT unda fiqrobdes am or aucilebel
daskvnaze da cdilobdes, isini maqsimalurad sarwmuno gaxados. aqve unda iTqvas, rom kvlevis
warmarTvis procesis logikuri Tanmimdevrobis
dacva zogjer saWiro ar aris. magaliTad, kvlevis pirvel etapze SeiZleba Segrovdes monacemebi, Semdeg ganisazRvros Sida sarwmunooba anu
gakeTdes Sida daskvna, ganzogaddes es daskvna gare sarwmunoobis gansazRvris saSualebiT da bo-
los gamotanil iqnes saerTo daskvna. amas marjvnidan marcxniv ganxorcielebuli kvleva ewodeba, logikuri mimarTulebiT, anu marcxnidan
marjvniv ganxorcieleba ki gulisxmobs kvlevis
proeqtirebas, kvlevis sakiTxis formirebas, dagegmvas da bolos _ mis praqtikul ganxorcielebas.
kvlevis ZiriTadi sakiTxi anu mizani aris
kiTxva, romelsac unda gaeces pasuxi. magaliTad,
hepatitis virusiT inficirebuli ramdeni narkomania TbilisSi. am SekiTxvaze amomwuravi pasuxis gacema ar SeiZleba, vinaidan, jer erTi, praqtikulad SeuZlebelia Tbilisis yvela narkomanis Seswavla virusis matareblobaze, meore _ inficirebis sadiagnostiko saSualebani ar iZleva
asprocentian Sedegs. aqedan gamomdinare, mkvlevari svams SedarebiT realur kiTxvas: narkologiur centrSi aRricxvaze myof narkomanTa ra nawilia inficirebuli hepatitis virusiT. amis
Semdeg xdeba dasmuli kiTxvis transformireba
kvlevis gegmaSi [3].
kvlevis CatarebisTvis saWiroa iseTi sakvlevi subieqtebis SerCeva, romlebic reprezentatiulni iqnebian da mogvcemen miRebuli Sedegebis ganzogadebis saSualebas. am SemTxvevaSi gamosavalia kvlevis Catareba narkologiuri centris kontingentze, Tumca araswori Sedegebis
miReba mainc aris mosalodneli, vinaidan centrSi
aRricxvaze, rasakvirvelia, yvela narkomani ar imyofeba.
meore mniSvnelovan komponents warmoadgens iseTi cvladebis SerCeva, romlebic reprezentatiuli iqneba CvenTvis saintereso fenomenis Sesaswavlad. magaliTad, hepatitis dros antisxeulebis gamokvleva kargi arCevania, Tumca
mainc ar SeiZleba, es meTodi idealurad CaiTvalos.
kvlevis gegmis realizaciis dros mniSvnelovania, ramdenad Seesabameba realurad Catarebuli gamokvlevebi gegmiT gaTvaliswinebuls.
sruli Sesabamisobis miRweva Znelia, rac kvlevis sarwmunoobas amcirebs. aseve mcirdeba sarwmunooba SemTxveviTi Sedegebis
(Secdomebis)
gamovlenis gamo (magaliTad, SemTxveviTi asociaciis dadgena romelime or cvlads Soris).
daviT Telias klinikuri leqciebis cikli
13
klinikuri kvlevebi
kvlevis ganxorcieleba
kvlevis ganxorcielebis dros metad mniSvnelovania, ramdenad Seesabameba realurad ganxorcielebuli kvleva (kvleva marjvnidan marcxniv) gegmiT gaTvaliswinebuls (marcxnidan
marjvniv) anu ramdenad SeiZleba vivaraudoT, rom
kvlevaSi wamoWril kiTxvaze pasuxi umarTebuloa imis gamo, rom kvleva ar Catarda gaTvaliswinebuli gegmiT. aseT SemTxvevaSi Secdomis albaToba gansakuTrebiT didia.
Secdomebi da maTi saxeebi
wfsd!fs!Uj!lwmf!wb!wfs!Db!ubs!ef!cb!vTfd!ep!.
npe-!bnj!upn!bsd!fs!Uj!Tf!ef!hj!bs!Tf!j[!mf!cb!jzpt
bc!tp!mv!uv!sbe!XfT!nb!sj!uj/ kvlevis dros maqsimalurad aris saWiro Sida kanonzomierebis maRal
sarwmunoobaze zrunva, raTa SesaZlebeli gaxdes
misi ganzogadeba (gare sarwmunooba). sabednierod, ndeb!sj! ebt!lwof!cjt! lpo!usp!mj! eb! Ub!wj!ebo
bdj!mf!cb! nfu!.obl!mf!cbe! Tf!tb[!mf!cf!mjb! lwmf!wjt
tywb!ebt!ywb!fubq!{f;!bob!mj!{jt-!!eb!hfh!nwj!tb!eb!hbo!.
yps!dj!f!mf!cjt!gb!{fc!Tj/
cxrili #2
kvlevis gegma
kvlevis elementi
saTauri
magaliTi
virusuli hepatitis gavrceleba narkomanebSi
mizani
1. Seswavlil iqnes hepatitis gavrceleba Tbilisis narkomanebs Soris
2. imave populaciaSi hepatitis riskfaqtorebis gamovlena da dadgena, aris Tu
ara am faqtorTa Soris rasobrivi Tavisebureba
mniSvneloba (mimoxilva)
1. hepatitis epidemia warmoadgens medicinis aqtualur problemas.
2. q. TbilisSi narkomanebi hepatitis wyaros warmoadgenen.
3. am populaciaSi hepatitis gavrcelebis codna xels Seuwyobs profilaqtikuri
RonisZiebebis dagegmvasa da ganxorcielebas.
4. infeqciis riskfaqtorebis codna iqneba mniSvnelovani informacia am infeqciis
kanonzomierebaTa dasadgenad, rac SesaZlebels gaxdis maRali riskjgufebis gamovlenas, riskenac unda iyos upiratesad mimarTuli profilaqtikuri RonisZiebani.
gegmis tipi
jvaredin-seqciuri kvleva deskrifciuli da analitikuri komponentebiT
kvlevis subieqti
narkomanebi, romlebic aRricxvaze arian q. Tbilisis narkologiur centrSi
amorGevis kriteriumebi
wonis kleba, nemsis sterilizacia
SerGevis meTodi
randomizacia
cvladebi:
prediqtorebi
asaki, sqesi, eTnosi
Sedegobrivi cvladebi antisxeulebi
statistikuri uzrunvelyofa, hipoTezebi da analizi
1) prevalentobis gansazRvra (ar moiTxovs hipoTezas). fiqsirdeba im subieqtebis
raodenoba, romlebsac aRmoaGndaT antisxeulebi.
2) analizuri uzrunvelyofa (moiTxovs hipoTezas, mag.: antisxeulebis gamovlenis
sixSire mamakacebSi ufro metia)
.amosakrebi populaciis raodenobis gansazRvra da sarwmunoobis Sefaseba
14
daviT Telias klinikuri leqciebis cikli
klinikuri kvlevebi
kvlevis dros SeiZleba gamovlindes ori
tipis Secdoma:
· Tfn!Uywf!wj!Uj<!
· tjt!uf!nb!uj!lv!sj/!
maT Soris gansxvavebis gaazreba metad
mniSvnelovania, vinaidan arsebobs maTi Tavidan
acilebis sxvadasxva xerxi. Tfn!Uywf!wj!Uj!Tfd!ep!.
nb!bsjt!ndeb!sj!Tf!ef!hj-!sp!nf!mjd!nj!Sf!cv!mjb!Tfn!.
Uywf!wjU!eb!nbt!tb!gv[!wmbe!vefwt!np!ob!dfn!Ub!dwb!.
mf!cb!ep!cjt! )wb!sj!bc! f!mv!sp!cjt*! vd!op!cj! nj!{f!{f!cj/
sakvlevi masalis raodenobis gazrdis Sedegad
SemTxveviTi Secdomebi sagrZnoblad mcirdeba.
JW!fmf!nfo!uj _ warmoadgens kvlevis praqtikuli ganxorcielebis dawvrilebiT instruqtaJs da moicavs specialur procedurul instruqciebs, kvlevis kiTxvarebs da sxva masalebs kvlevis standartuli da unificirebuli
warmarTvis uzrunvelyofis mizniT.
mogvyavs kvlevis gegmis konkretuli magaliTi cxrili #2-is saxiT.
tjt!uf!nb!uj!lv!sj!Tfd!ep!nb!bsjt!XfT!nb!sj!uf!cj!.
ebo! nyp!mpe! fs!Uj! nj!nbs!Uv!mf!cjU! hb!eby!sj!mj
ndeb!sj!Tf!ef!hj/ sistematikuri Secdomis magaliTia subieqtivizmi da tendencia kvlevis dros.
sakvlevi masalis raodenobis gazrda sistematikur Secdomas Tavidan ver agvacilebs. es SesaZlebelia mxolod sxvadasxva tipis kontrolirebadi (magaliTad, randomizebuli, ormag-jvaredini) kvlevis Catarebis gziT.
kvlevis gegma
kvlevis gegma moicavs oTx Tanamimdevruli
elements. maTi rekomendebuli formati aseTia:
J!fmf!nfo!uj _ kvlevis sakiTxi. gamoiTqmis
erTi winadadebiT da asaxavs ZiriTad kiTxvas,
romelsac unda gaeces pasuxi.
JJ!!fmf!nfo!uj _ warmodgenil unda iqnes 12 gverdze da dawvrilebiT moicavs kvlevis yvela elements. misi warmarTva rekomendebulia
cxrili 1-is mixedviT. aseTi midgoma saSualebas
iZleva, kvleva warimarTos mkacrad Camoyalibebuli standartuli elementebis gamoyenebiT da maTi qronologiurobis dacviT.
JJJ!fmf!nfo!uj!_ warmoadgens kvlevis protokols, romelic meore elementis sruli, gavrcobili variantia. igi SeiZleba moicavdes 5-100
gverds. sruli protokoli aris ZiriTadi dokumenti, romelic gamoiyeneba grantebis dagegmvisa da ganxorcielebisTvis.
daviT Telias klinikuri leqciebis cikli
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klinikuri kvlevebi
literatura
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likelihood ratios. BMJ 329: 168-169
2. Altman, D G, Bland, J M (1994). Statistics Notes:
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9. Jadad AR, Rennie D. The randomized controlled trial
gets a middle-aged checkup. JAMA 1998;279:319-20.
10. Altman DG. Practical statistics for medical research.
London: Chapman & Hall, 1991.
11. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical
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daviT Telias klinikuri leqciebis cikli