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Randomized controlled trials (RCTS) ndiyo chiyero chegoridhe chekuongorora kuchengetedzeka uye kushanda kwekurapa. Zvisinei, mune dzimwe nguva, RCT haigoneki, saka dzimwe nyanzvi dzinoisa mberi nzira yekugadzira zvidzidzo zvekucherechedza maererano nenheyo yeRCT, kureva, kuburikidza ne "target experiment simulation", zvidzidzo zvekucherechedza zvinofananidzwa muRCT kuti ivandudze kushanda kwayo.

Randomized controlled trials (RCTS) ndiyo nzira yekuongorora kuchengetedzwa kwehukama uye kushanda kwehutano hwehutano. Kunyangwe ongororo ye data yekucherechedza kubva kuzvidzidzo zve epidemiological uye dhatabhesi rezvokurapa (kusanganisira rekodhi rekodhi rekodhi [EHR] uye data yezvichemo zvekurapa) zvine zvakanakira saizi hombe dzemuenzaniso, kuwana panguva yakakodzera kune data, uye kugona kuongorora "chaiyo nyika" mhedzisiro, ongororo iyi inotaridza kurerekera kunokanganisa simba rehumbowo hwavanoburitsa. Kwenguva yakareba, yakakurudzirwa kugadzira zvidzidzo zvekucherechedza maererano nemitemo yeRCT yekuvandudza kutendeseka kwezviwanikwa. Kune akati wandei nzira dzemaitiro dzinoedza kutora causal inferences kubva pakuona data, uye nhamba iri kukura yevatsvaguri vari kutevedzera magadzirirwo ezvidzidzo zvekuongorora kune hypothetical RCTS kuburikidza ne "chinangwa chekuyedza simulation."

Icho chinangwa chekuyedza kuenzanisa chimiro chinoda kuti dhizaini uye ongororo yezvidzidzo zvekutarisa zvienderane nekufungidzira RCTS inotarisana nemubvunzo wakafanana wekutsvaga. Kunyange zvazvo nzira iyi inopa nzira yakarongeka yekugadzira, kuongorora, uye kushuma kune mukana wekuvandudza hutano hwezvidzidzo zvekucherechedza, zvidzidzo zvakaitwa nenzira iyi zvichiri kutarisana nekusarura kubva kune dzakawanda zvinyorwa, kusanganisira kuvhiringidza migumisiro kubva kune vasina kucherechedzwa covariates. Zvidzidzo zvakadaro zvinoda zvakadzama dhizaini zvinhu, nzira dzekuongorora dzekugadzirisa zvinovhiringidza zvinhu, uye mishumo yekuongorora yekunzwa.
Muzvidzidzo vachishandisa nzira yekufananidza-yekuedza, vatsvakurudzi vakaisa yekufungidzira RCTS iyo yaizogona kuitwa kugadzirisa rimwe dambudziko rekutsvagisa, uye vozoisa maitiro ekuongorora ekuongorora anoenderana neiyo "chinangwa-bvunzo" RCTS. Zvinodiwa zvekugadzira zvinhu zvinosanganisira kubatanidzwa kwemaitiro ekuregererwa, kusarudzwa kwevatori vechikamu, nzira yekurapa, kugoverwa kwekurapa, kutanga uye kupera kwekutevera, matanho emigumisiro, kuongorora kushanda, uye hurongwa hwekuongorora nhamba (SAP). Somuenzaniso, Dickerman et al. akashandisa tarisiro-yeyedzo yekutevedzera chimiro uye yakashandisa EHR data kubva kuUS Dhipatimendi reVeterans Affairs (VA) kuenzanisa kushanda kweBNT162b2 uye mRNA-1273 yekudzivirira mukudzivirira hutachiona hweSARS-CoV-2, kuchipatara, uye kufa.

Chinokosha chekuenzanisa kwechinangwa chekuedza ndechekuisa "nguva zero," iyo nguva iyo kukodzera kwevatori vechikamu kunoongororwa, kurapwa kunopiwa, uye kutevera kunotanga. Muchidzidzo chekudzivirira cheVA Covid-19, nguva zero yakatsanangurwa sezuva rekutanga dosi rekudzivirira. Kubatanidza nguva yekuona kukodzera, kugovera kurapwa, uye kutanga kutevera kusvika kunguva zero kunoderedza zvinyorwa zvakakosha zvekusarura, kunyanya kusingafi nguva yekusarura pakugadzirisa mazano ekurapa mushure mekutanga kutevera, uye kusarudzwa kwekusarudza mukutanga kutevera mushure mekupa kurapwa. KuVA
Muchidzidzo chekudzivirira cheCovid-19, kana vatori vechikamu vakapihwa kuboka rekurapa kuti vaongororwe zvichibva pakuti pavakagamuchira mushonga wechipiri wejekiseni, uye kutevera kwakatangwa panguva yedasi rekutanga rejekiseni, pakanga paine kurerekera kusiri kwerufu; Kana boka rekurapa rakagoverwa panguva yekutanga yekudzivirira uye kutevera kunotanga panguva yepiritsi yekudzivirira, kusarudzwa kwekusarudza kunomuka nokuti avo chete vakagamuchira miviri miviri yekudzivirira ichabatanidzwa.

Target test simulations inobatsirawo kudzivirira mamiriro ezvinhu apo mhedzisiro yekurapa haina kutsanangurwa zvakajeka, dambudziko rinowanzoitika muongororo yekuongorora. Muchidzidzo chevaccine cheVA Covid-19, vaongorori vakafananidza vatori vechikamu zvichienderana nehunhu hwekutanga uye vakaongororwa kushanda kwekurapa zvichibva pamusiyano wenjodzi yemhedzisiro pamavhiki makumi maviri nemana. Iyi nzira inotsanangura zvakajeka fungidziro semisiyano mumhedzisiro yeCCIDID-19 pakati pehuwandu hwakabaiwa nehupamhi hwekutanga maficha, akafanana neRCT efficacy fungidziro yedambudziko rimwe chete. Sezvakataurwa nevanyori veongororo, kuenzanisa mibairo yemishonga miviri yakafanana kunogona kusakanganiswa nezvinhu zvinovhiringa pane kuenzanisa zvinobuda zvevanhu vakabayiwa uye vasina kubayiwa.

Kunyange kana zvinhu zvichinyatsoenderana neRCTS, kutendeseka kwechidzidzo uchishandisa chinangwa-chiedzo chekufananidza chimiro chinoenderana nekusarudzwa kwemafungiro, magadzirirwo uye nzira dzekuongorora, uye hutano hwemashoko ari pasi. Kunyange zvazvo chokwadi chemigumisiro yeRCT inobvawo pahutano hwekugadzira uye kuongorora, migumisiro yezvidzidzo zvekuongorora inotyisidzirwawo nezvinhu zvinovhiringidza. Sezvidzidzo zvisiri zverandomized, zvidzidzo zvekucherechedza hazvidzivirirwe kune zvinovhiringidza zvinhu zvakadai seRCTS, uye vatori vechikamu nevarapi havasi mapofu, izvo zvingakanganisa kuongororwa kwemigumisiro uye zvidzidzo zvekudzidza. Muchidzidzo chevaccine cheVA Covid-19, vaongorori vakashandisa nzira yekubatanidza kuenzanisa kugovaniswa kwehunhu hwemapoka maviri evatori vechikamu, kusanganisira zera, bonde, dzinza, uye dhigirii rekugara mumadhorobha. Misiyano mukugovaniswa kwehumwe hunhu, hwakadai sekugara, inogona zvakare kuve yakabatana nenjodzi yekutapukirwa neCovid-19 uye ichave inosarira confounders.

Zvidzidzo zvakawanda zvinoshandisa nzira dzekuyedza-yekutevedzera zvinoshandisa “data renyika chaiyo” (RWD), senge data reEHR. Zvikomborero zveRWD zvinosanganisira kuva panguva yakakodzera, scalable, uye kufungisisa kwemaitiro ekurapa mukutarisira kwakajairika, asi kunofanira kuyerwa maererano nenyaya dzehutano hwe data, kusanganisira kushayikwa kwemashoko, kusaziva uye kusinganzwisisiki kwekuzivikanwa uye tsanangudzo yevatori vechikamu maitiro nemigumisiro, kusapindirana kwekutonga kwekurapa, maitiro akasiyana-siyana ekuongororwa kwekutevera, uye kurasikirwa kwekuwana ruzivo rwakasiyana-siyana nekuda kwekuendeswa kwehutano hwehutano hwakasiyana-siyana. Chidzidzo cheVA chakashandisa data kubva kune imwe EHR, iyo yakaderedza kushushikana kwedu pamusoro pekusawirirana kwedata. Zvisinei, kusimbiswa kusina kukwana uye zvinyorwa zvezviratidzo, kusanganisira comorbidities nemigumisiro, inoramba iri ngozi.
Kusarudzwa kwevatori vechikamu mumasampuli ekuongorora kunowanzobva pane data retrospective, izvo zvinogona kutungamirira kusarudzo yekusarura nekusabatanidza vanhu vasina ruzivo rwekutanga. Nepo matambudziko aya asiri ega kuzvidzidzo zvekutarisa, ndiwo masosi ekusarira akasarudzika ayo anonangana nemiedzo haigone kugadzirisa zvakananga. Mukuwedzera, zvidzidzo zvekucherechedza kazhinji hazvisati zvanyoreswa, izvo zvinowedzera nyaya dzakadai sekunzwa kwekugadzira uye kusarura kwekubudisa. Nekuti kwakasiyana dhata masosi, magadzirirwo, uye nzira dzekuongorora dzinogona kuburitsa mhedzisiro dzakasiyana, dhizaini yekudzidza, nzira yekuongorora, uye data sosi yekusarudza hwaro inofanira kufanotemerwa.

Pane nhungamiro yekuitisa uye kushuma zvidzidzo uchishandisa iyo yakanangwa yeedzero framework iyo inovandudza kunaka kwechidzidzo uye kuona kuti mushumo wacho wakadzama zvakakwana kuti muverengi anyatsouongorora. Kutanga, mapurogiramu ekutsvakurudza uye SAP inofanira kugadzirirwa mberi pamberi pekuongorora data. SAP inofanira kusanganisira nzira dzakadzama dzehuwandu hwekugadzirisa kusarura nekuda kwevanovhiringidza, pamwe nekuongorora kwekunzwa kuongorora kusimba kwemigumisiro inopesana nemasimba makuru ekusarura akadai sevanovhiringidza uye data inoshaya.

Musoro, zvisinganzwisisiki, uye nzira zvikamu zvinofanira kujekesa kuti chidzidzo chekudzidza chidzidzo chekucherechedza kudzivirira kuvhiringidzika neRCTS, uye inofanira kusiyanisa pakati pezvidzidzo zvekucherechedza zvakaitwa uye miedzo yekufungidzira iyo iri kuedza kutevedzera. Mutsvaguri anofanirwa kudoma nhanho dzemhando senge kunobva data, kuvimbika uye kutendeseka kwezvinhu zve data, uye, kana zvichibvira, nyora zvimwe zvakaburitswa zvidzidzo uchishandisa iyo data sosi. Muongorori anofanirawo kupa tafura inotsanangura zvinhu zvekugadzira zvechinangwa chekuedza uye kuenzanisa kwayo kwekucherechedza, pamwe chete nechiratidzo chakajeka chenguva yekuziva kukodzera, kutanga kutevera, uye kugovera kurapwa.
Mune zvidzidzo zvinoshandisa kuenzanisa kwekuedzwa kwechinangwa, apo chirongwa chekurapa chisingagoni kutsanangurwa pakutanga (zvakadai sezvidzidzo pamusoro penguva yekurapa kana kushandiswa kwemishonga yakasanganiswa), kugadziriswa kwekusarura kusiri kwekufa nguva kunofanira kutsanangurwa. Vatsvaguri vanofanirwa kuzivisa zvine musoro ongororo yekuongorora kuti vaone kusimba kwemhedzisiro yezvidzidzo kune akakosha masosi erusaruro, kusanganisira kuverengera mhedzisiro inogona kuitika yeanobtrusive confounders uye kuongorora shanduko mumhedzisiro kana zvakakosha magadzirirwo aiswa neimwe nzira. Kushandiswa kwemigumisiro yakaipa yekutonga (migumisiro yakasimba isingaenderani nekuratidzwa kwekunetseka) inogonawo kubatsira kuverenga zvakasara.

Kunyange zvazvo zvidzidzo zvekucherechedza zvinogona kuongorora nyaya dzingave dzisingagoneki kuitisa RCTS uye dzinogona kutora mukana weRWD, zvidzidzo zvekucherechedza zvinewo zvakawanda zvinogona kukonzera kusarura. Iyo inonangwa yekuyedza simulation framework inoedza kugadzirisa zvimwe zvekusarura uku, asi inofanirwa kutevedzerwa uye kutaurwa nemazvo. Nemhaka yokuti zvinokanganisa zvinogona kutungamirira kune rusaruro, kuongorora kwekunzwa kunofanira kuitwa kuongorora kusimba kwemigumisiro pamusoro pevanovhiringidza vasingaonekwi, uye migumisiro inofanira kududzirwa kuti ifunge nezvekuchinja kwemigumisiro kana mamwe mafungiro akaitwa pamusoro pevavhiringidzi. Chiyedzo chekuyedza dhizaini, kana chikaitwa zvine hungwaru, chinogona kuva nzira inobatsira yekumisikidza madhizaini ekuongorora, asi haisi mushonga.