Izilingo ezilawulwa ngokungahleliwe (RCTS) ziyizinga eligolide lokuhlola ukuphepha nokusebenza kokwelashwa. Kodwa-ke, kwezinye izimo, i-RCT ayinakwenzeka, ngakho-ke ezinye izazi zibeka phambili indlela yokuklama izifundo zokubheka ngokuvumelana nesimiso se-RCT, okungukuthi, ngokusebenzisa "i-target experiment simulation", izifundo zokubheka zifaniswe ku-RCT ukuze kuthuthukiswe ukufaneleka kwayo.
Izivivinyo ezilawulwa ngokungahleliwe (RCTS) ziyimibandela yokuhlola ukuphepha okuhlobene nokusebenza kokungenelela kwezokwelapha. Nakuba ukuhlaziya idatha yokuqaphela evela ezifundweni ze-epidemiological kanye nemininingwane yolwazi lwezokwelapha (okuhlanganisa irekhodi lezokwelapha lika-elekthronikhi [EHR] kanye nedatha yezicelo zezokwelapha) kunezinzuzo zamasayizi amakhulu amasampula, ukufinyelela okufika ngesikhathi kudatha, kanye nekhono lokuhlola imiphumela “yomhlaba wangempela”, lokhu kuhlaziya kuthambekele ekuchemameni okubukela phansi amandla obufakazi ezibukhiqizayo. Sekuyisikhathi eside, kuphakanyiswe ukuklama izifundo zokubheka ngokuvumelana nezimiso ze-RCT ukuze kuthuthukiswe ukufaneleka kokutholwe. Kunezindlela ezimbalwa ze-methodological ezizama ukudweba okucatshangelwayo okuyimbangela kudatha yokuqaphela, futhi inani elikhulayo labacwaningi lilingisa idizayini yezifundo zokuqaphela ku-RCTS yokucabanga “ngokulinganisa isilingo esiqondiwe.”
Uhlaka oluqondisiwe lokulingisa isilingo ludinga ukuthi ukuklama nokuhlaziywa kwezifundo zokubheka kuhambisane ne-RCTS yokucabanga ebhekana nombuzo ofanayo wocwaningo. Nakuba le ndlela inikeza indlela ehlelekile yokuklama, ukuhlaziya, kanye nokubika okunamandla okuthuthukisa ikhwalithi yezifundo zokubheka, izifundo eziqhutshwa ngale ndlela zisathambekele ekukhetheni okuvela emithonjeni eminingi, kuhlanganise nemiphumela edidayo evela kuma-covariate angabonakali. Ucwaningo olunjalo ludinga izakhi zedizayini ezinemininingwane, izindlela zokuhlaziya ukubhekana nezinto ezididayo, nemibiko yokuhlaziya ukuzwela.
Ocwaningweni olusebenzisa indlela yokulingisa yokuhlola okuqondisiwe, abacwaningi bamisa i-RCTS yokucabanga engenziwa kahle ukuxazulula inkinga ethile yocwaningo, bese basetha izici zedizayini zokuhlola ezihambisana naleyo RCTS "yokuhlola okuqondisiwe". Izakhi ezidingekayo zokuklama zihlanganisa ukufakwa kwemibandela yokukhishwa, ukukhethwa kwabahlanganyeli, isu lokwelashwa, isabelo sokwelashwa, ukuqala nokuphela kokulandela, izinyathelo zomphumela, ukuhlolwa kokusebenza kahle, kanye nohlelo lokuhlaziya izibalo (SAP). Ngokwesibonelo, u-Dickerman et al. isebenzise uhlaka lokulingisa okuhlosiwe futhi yasebenzisa idatha ye-EHR evela eMnyangweni Wezindaba Zomakadebona wase-US (VA) ukuze iqhathanise ukuphumelela kwemithi yokugomela i-BNT162b2 kanye ne-mRNA-1273 ekuvimbeleni izifo ze-SARS-CoV-2, ukulaliswa esibhedlela, nokufa.
Ukhiye ekulingiseni ukuhlola okuhlosiwe ukusetha "isikhathi esiyiziro," iphuzu ngesikhathi lapho kuhlolwa khona ukufaneleka komhlanganyeli, ukwelashwa kwabelwe, futhi ukulandelela kuqaliswa. Ocwaningweni lokugomela i-VA Covid-19, uziro wesikhathi wachazwa njengosuku lomthamo wokuqala womgomo. Ukuhlanganisa isikhathi sokunquma ukufaneleka, ukwabela ukwelashwa, nokuqala ukulandelwa kuze kufike ku-zero kunciphisa imithombo ebalulekile yokuchema, ikakhulukazi ubandlululo lwesikhathi esingenakufa ekunqumeni amasu okwelapha ngemva kokuqala ukulandelwa, kanye nokukhethwa kokukhetha ekuqaliseni ukulandelwa ngemva kokunikeza ukwelashwa. E-VA
Ocwaningweni lokugomela i-Covid-19, uma ababambiqhaza babelwa eqenjini lokwelapha ukuze bahlaziywe ngokusekelwe lapho bethola umthamo wesibili womgomo, futhi ukulandelela kwaqalwa ngesikhathi somthamo wokuqala womgomo, kwakukhona ukuchema okungesona isikhathi sokufa; Uma iqembu lokwelapha linikezwa ngesikhathi somthamo wokuqala wokugoma futhi ukulandelwa kuqala ngesikhathi somthamo wesibili wokugoma, ukukhethwa kokukhetha kuvela ngoba kuphela labo abathola imithamo emibili yokugoma bazofakwa.
Ukulingiswa kwesilingo esiqondisiwe futhi kusiza ukugwema izimo lapho imiphumela yokwelapha ingachazwanga kahle, ubunzima obuvamile ezifundweni zokuqaphela. Ocwaningweni lokugomela i-VA Covid-19, abacwaningi bafanise ababambiqhaza ngokusekelwe ezicini eziyisisekelo futhi bahlola ukusebenza kahle kokwelashwa ngokusekelwe umehluko wengozi yomphumela emavikini angama-24. Le ndlela ichaza ngokucacile izilinganiso zokuphumelela njengomehluko emiphumeleni ye-Covid-19 phakathi kwabantu abagonyiwe abanezici eziyisisekelo ezilinganiselwe, ezifana nezilinganiso zokuphumelela ze-RCT zenkinga efanayo. Njengoba ababhali bocwaningo beveza, ukuqhathanisa imiphumela yemithi yokugoma emibili efanayo kungase kuthonywe kancane izinto ezididayo kunokuqhathanisa imiphumela yabantu abagonyiwe nabangakagonywa.
Ngisho noma ama-elementi aqondaniswe ngempumelelo ne-RCTS, ukufaneleka kocwaningo kusetshenziswa uhlaka lokulingisa okuqondisiwe kuncike ekukhethweni kokuqagela, izindlela zokuklama nokuhlaziya, kanye nekhwalithi yedatha eyisisekelo. Nakuba ukufaneleka kwemiphumela ye-RCT nakho kuncike kukhwalithi yokuklama nokuhlaziywa, imiphumela yezifundo zokubuka iphinde isongelwa yizici ezididayo. Njengezifundo ezingahleliwe, izifundo zokuqaphela azigonyiwe ezicini ezididayo njenge-RCTS, futhi ababambiqhaza nabahlengikazi abazona izimpumputhe, ezingase zithinte ukuhlolwa kwemiphumela nemiphumela yocwaningo. Ocwaningweni lokugomela i-VA Covid-19, abacwaningi basebenzise indlela yokumatanisa ukulinganisa ukusatshalaliswa kwezimpawu eziyisisekelo zamaqembu amabili ababambiqhaza, okuhlanganisa iminyaka, ubulili, ubuzwe, kanye nezinga lokuya emadolobheni lapho behlala khona. Umehluko ekusabalaliseni ezinye izici, njengomsebenzi, ungase uhlotshaniswe nengozi yokutheleleka nge-Covid-19 futhi kuzoba yiziphazamisi ezisalela.
Ucwaningo oluningi olusebenzisa izindlela zokulingisa okuhlosiwe zisebenzisa “idatha yomhlaba wangempela” (RWD), njengedatha ye-EHR. Izinzuzo ze-RWD zihlanganisa ukufika ngesikhathi, ukukala, nokucabangela amaphethini okwelashwa ekunakekelweni okuvamile, kodwa kufanele kulinganiswe nezindaba zekhwalithi yedatha, okuhlanganisa idatha engekho, ukuhlonza okungalungile nokungahambisani kanye nencazelo yezimpawu nemiphumela yokubamba iqhaza, ukuphathwa okungahambisani nokwelashwa, imvamisa ehlukene yokuhlola okulandelwayo, kanye nokulahlekelwa kokufinyelela kwedatha ngenxa yokudluliselwa kwezinhlelo zezempilo ezihlukene phakathi kwabahlanganyeli. Ucwaningo lwe-VA lusebenzise idatha evela ku-EHR eyodwa, eyehlisa ukukhathazeka kwethu mayelana nokungahambisani kwedatha. Kodwa-ke, ukuqinisekiswa okungaphelele kanye nokubhalwa kwezinkomba, okuhlanganisa ukugula kanye nemiphumela, kuseyingozi.
Ukukhethwa kombambiqhaza kumasampuli okuhlaziya kuvame ukusekelwe kudatha yokubuka emuva, okungaholela ekukhetheni ukukhetha ngokungabandakanyi abantu abanolwazi oluyisisekelo olungekho. Nakuba lezi zinkinga zingagcini nje ezifundweni zokuqaphela, ziyimithombo yokuchema okuyinsalela okuqondiswe ekufanisweni kwesilingo okungakwazi ukubhekana ngqo. Ukwengeza, izifundo zokuqaphela ngokuvamile azibhaliswa ngaphambili, okwandisa izinkinga ezifana nokuzwela kwedizayini nokuchema kokushicilela. Ngenxa yokuthi imithombo yedatha ehlukene, imiklamo, nezindlela zokuhlaziya zingaveza imiphumela ehluke kakhulu, idizayini yocwaningo, indlela yokuhlaziya, nesisekelo sokukhetha umthombo wedatha kufanele kunqunywe kusengaphambili.
Kunemihlahlandlela yokuqhuba kanye nokubika izifundo kusetshenziswa uhlaka lokulingisa okuhlosiwe oluqondisa ikhwalithi yocwaningo futhi luqinisekise ukuthi umbiko unemininingwane eyanele ukuze umfundi awuhlole ngokujulile. Okokuqala, izivumelwano zocwaningo kanye ne-SAP kufanele zilungiswe kusengaphambili ngaphambi kokuhlaziywa kwedatha. I-SAP kufanele ifake izindlela zezibalo ezinemininingwane zokubhekana nokuchema ngenxa yeziphambano, kanye nokuhlaziywa kokuzwela ukuze kuhlolwe ukuqina kwemiphumela ngokumelene nemithombo emikhulu yokuchema efana neziphambano kanye nedatha engekho.
Isihloko, i-abstract, nezigaba zezindlela kufanele zikwenze kucace ukuthi idizayini yocwaningo iwucwaningo lokubheka ukuze kugwenywe ukudideka nge-RCTS, futhi kufanele kuhlukanise phakathi kwezifundo zokuqaphela ezenziwe kanye nokuhlola okucatshangwayo okuzama ukulingisa. Umcwaningi kufanele acacise izilinganiso zekhwalithi njengomthombo wedatha, ukwethembeka nokuba semthethweni kwezakhi zedatha, futhi, uma kungenzeka, abhale ezinye izifundo ezishicilelwe kusetshenziswa umthombo wedatha. Umphenyi kufanele futhi anikeze ithebula elichaza izici zedizayini zohlolo oluqondiwe kanye nokulingisa kwayo kokubuka, kanye nenkomba ecacile yokuthi kunini lapho kunqunywa khona ukufaneleka, ukuqalisa ukulandelela, nokwabela ukwelashwa.
Ocwaningweni olusebenzisa ukulingisa kwesilingo esiqondisiwe, lapho isu lokwelapha lingakwazi ukunqunywa ekuqaleni (njengezifundo zesikhathi sokwelashwa noma ukusetshenziswa kwenhlanganisela yokwelapha), isinqumo sokuchema okungekona okokufa kufanele kuchazwe. Abacwaningi kufanele babike ukuhlaziya okuzwakalayo kokuzwela ukuze bahlole ukuqina kwemiphumela yocwaningo emithonjeni ebalulekile yokuchema, okuhlanganisa ukulinganisa umthelela ongaba khona weziphambanisi ezingabonakali kanye nokuhlola izinguquko emiphumeleni lapho izici zomklamo eziyinhloko zisethwa ngenye indlela. Ukusetshenziswa kwemiphumela yokulawula engemihle (imiphumela engahlobene kakhulu nokuchayeka kokukhathazeka) nakho kungasiza ukulinganisa ukuchema okuyinsalela.
Nakuba izifundo zokuqaphela zingahlaziya izinkinga okungenzeka zingenzeki i-RCTS futhi zingasebenzisa i-RWD, izifundo zokubheka nazo zinemithombo eminingi engaba khona yokuchema. Uhlaka oluhlosiwe lokulingisa isilingo luzama ukubhekana nokunye kwalokhu kuchema, kodwa kufanele lufaniswe futhi lubikwe ngokucophelela. Ngenxa yokuthi ama-confounders angaholela ekuchemani, ukuhlaziya ukuzwela kufanele kwenziwe ukuze kuhlolwe ukuqina kwemiphumela ngokumelene nama-confounders angabonakali, futhi imiphumela kufanele ihunyushwe ukuze kucatshangelwe izinguquko emiphumeleni lapho okunye ukucatshangelwa kwenziwa mayelana nabaphambanisi. Uhlaka oluhlosiwe lokulingisa isilingo, uma lusetshenziswa ngokuqinile, lungaba indlela ewusizo yokubeka ngokuhlelekile imiklamo yocwaningo lokuqaphela, kodwa alulona ikhambi.
Isikhathi sokuthumela: Nov-30-2024