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Iimvavanyo ezilawulwa ngokungahleliwe (RCTS) zisemgangathweni wegolide wokuvavanya ukhuseleko kunye nokusebenza kakuhle kwonyango. Nangona kunjalo, kwezinye iimeko, i-RCT ayinakwenzeka, ngoko ke abanye abaphengululi babeka phambili indlela yokuyila izifundo zokuqwalasela ngokomgaqo we-RCT, oko kukuthi, "ngokulinganisa okujoliswe kuko", izifundo zokuqwalasela zifaniswe kwi-RCT ukuphucula ukuqinisekiswa kwayo.

Izilingo ezilawulwa ngokungahleliwe (RCTS) ziinqobo zokuvavanya ukhuseleko olunxulumeneyo kunye nokusebenza kongenelelo lwezonyango. Nangona uhlalutyo lwedatha yokuqaphela evela kwizifundo ze-epidemiological kunye nogcino lweenkcukacha zonyango (kubandakanywa irekhodi yezonyango ye-elektroniki [EHR] kunye neenkcukacha zamabango ezonyango) zineenzuzo zobukhulu beesampulu ezinkulu, ukufikelela ngexesha elifanelekileyo kwidatha, kunye nokukwazi ukuhlola iziphumo "zehlabathi lokwenyani", olu hlalutyo luthambekele ekuthandeni okujongela phantsi amandla obungqina ababuvelisayo. Kwangexesha elide, kuye kwacetyiswa ukuba kuyilwe izifundo zokuqwalasela ngokwemigaqo ye-RCT yokuphucula ukuqinisekiswa kweziphumo. Kukho inani leendlela zemethodological ezizama ukuzoba inferences ye-causal evela kwidatha yoqwalaselo, kwaye inani elikhulayo labaphandi lilinganisa uyilo lwezifundo zoqwalaselo kwi-RCTS ye-hypothetical RCTS ngokuthi "ukulinganisa ulingo olujoliswe kuyo."

Inkqubo yokulinganisa yovavanyo olujoliswe kuyo ifuna ukuba uyilo kunye nohlalutyo lwezifundo zoqwalaselo zihambelane ne-RCTS yoqikelelo olujongana nombuzo wophando ofanayo. Nangona le ndlela ibonelela ngendlela ecwangcisiweyo yokuyila, ukuhlalutya, kunye nokunika ingxelo ekwaziyo ukuphucula umgangatho wezifundo zokuqwalasela, izifundo eziqhutywe ngolu hlobo zisaxhomekeke kwi-bias evela kwimithombo emininzi, kubandakanywa nemiphumo ephazamisayo evela kwi-covariates engabonakaliyo. Uphononongo olunjalo lufuna izinto zoyilo oluneenkcukacha, iindlela zokuhlalutya ukujongana nezinto ezididayo, kunye neengxelo zokuhlalutya ubuntununtunu.
Kuphononongo olusebenzisa indlela yokulinganisa ekujoliswe kuyo, abaphandi bamisela i-RCTS ecingelwayo eya kwenziwa ngokufanelekileyo ukusombulula ingxaki ethile yophando, kwaye emva koko ibeke izinto zoyilo lophononongo lokujonga ezihambelana ne-RCTS "yovavanyo ekujoliswe kuyo". Izinto eziyimfuneko zokuyila zibandakanya ukufakwa kweendlela zokukhutshwa, ukukhethwa komthathi-nxaxheba, isicwangciso sonyango, isabelo sonyango, ukuqala kunye nokuphela kokulandelelana, imilinganiselo yeziphumo, uvavanyo olusebenzayo, kunye nesicwangciso sokuhlalutya izibalo (SAP). Ngokomzekelo, uDickerman et al. wasebenzisa isakhelo sokulinganisa ekujoliswe kuso kwaye wasebenzisa idatha ye-EHR evela kwiSebe leMicimbi yamagqala e-US (VA) ukuthelekisa ukusebenza kogonyo lwe-BNT162b2 kunye ne-mRNA-1273 ekuthinteleni usulelo lwe-SARS-CoV-2, ukulaliswa esibhedlele, kunye nokufa.

Isihluthulelo sokulinganisa ulingo olujoliswe kuyo kukusetha "ixesha le-zero," inqaku ngexesha apho ukufaneleka komthathi-nxaxheba kuhlolwa khona, unyango lunikezelwe, kwaye ukulandelwa kuqaliswe. Kuphononongo lwesitofu sokugonya se-VA Covid-19, ixesha elinguziro lachazwa njengomhla wedosi yokuqala yesitofu sokugonya. Ukudibanisa ixesha lokumisela ukufaneleka, ukwabela unyango, kunye nokuqalisa ukulandelelana ukuya kwixesha le-zero kunciphisa imithombo ebalulekileyo yokuxhatshazwa, ngokukodwa ixesha lokungafiyo ekunqumeni izicwangciso zonyango emva kokuqala ukulandelwa, kunye nokukhethwa kokukhetha ekuqaliseni ukulandelwa emva kokunikezela unyango. KwiVA
Kuphononongo lwesitofu sokugonya se-Covid-19, ukuba abathathi-nxaxheba babelwa kwiqela lonyango ukuze bahlalutywe ngokusekelwe xa befumana idosi yesibini yesitofu sokugonya, kwaye ulandelelwano lwaqaliswa ngexesha ledosi yokuqala yesitofu sokugonya, bekukho ukuthambekela okungeyokufa kwexesha; Ukuba iqela lonyango linikezelwe ngexesha le-dose yokuqala yesitofu sokugonya kwaye ukulandelwa kuqala ngexesha lomthamo wesibini wokugonya, ukhetho olukhethiweyo luvela ngenxa yokuba kuphela abo bafumana iidosi ezimbini zokugonya baya kufakwa.

Ukulinganisa ulingo olujoliswe kuyo kwakhona kunceda ukuphepha iimeko apho iziphumo zonyango zingachazwanga ngokucacileyo, ubunzima obuqhelekileyo kwizifundo zokuqwalasela. Kuphononongo lwesitofu sokugonya se-VA Covid-19, abaphandi badibanisa abathathi-nxaxheba ngokusekwe kwiimpawu ezisisiseko kunye novavanyo olusebenzayo lonyango olusekwe kumahluko kumngcipheko weziphumo kwiiveki ezingama-24. Le ndlela ichaza ngokucacileyo uqikelelo olusebenzayo njengomahluko kwiziphumo ze-Covid-19 phakathi kwabantu abagonyiweyo abaneempawu ezisisiseko ezilinganayo, ezifana noqikelelo lwe-RCT olusebenzayo kwingxaki efanayo. Njengoko ababhali bophononongo bechaza, ukuthelekisa iziphumo zezitofu zokugonya ezimbini ezifanayo kunokuphenjelelwa kancinci ngezinto ezibhidayo kunokuthelekisa iziphumo zabantu abagonyiweyo kunye nabangagonywanga.

Nokuba izinto zilungelelaniswe ngempumelelo ne-RCTS, ukuqinisekiswa kophononongo kusetyenziswa isakhelo sokulinganisa ekujoliswe kuso sixhomekeke ekukhethweni kweengqikelelo, ukuyila kunye neendlela zokuhlalutya, kunye nomgangatho wedatha esisiseko. Nangona ukuqinisekiswa kweziphumo ze-RCT kuxhomekeke kumgangatho woyilo kunye nohlalutyo, iziphumo zezifundo zokuqwalasela nazo zisongelwa yizinto eziphazamisayo. Njengezifundo ezingezizo ezothutho, izifundo zokujonga azikhuselekanga kwizinto eziphazamisayo ezifana ne-RCTS, kwaye abathathi-nxaxheba kunye neekliniki abangaboniyo, ezinokuchaphazela uvavanyo lweziphumo kunye neziphumo zokufunda. Kuphononongo lwesitofu sokugonya se-VA Covid-19, abaphandi basebenzise indlela yokudibanisa ukulungelelanisa ukuhanjiswa kweempawu ezisisiseko zamaqela amabini abathathi-nxaxheba, kubandakanya iminyaka, isini, ubuhlanga, kunye nenqanaba lokufudukela ezidolophini apho bahlala khona. Umahluko ekusasazweni kwezinye iimpawu, ezifana nomsebenzi, unokunxulunyaniswa nomngcipheko wokosuleleka yi-Covid-19 kwaye iya kuba yintsalela ebhidayo.

Izifundo ezininzi zisebenzisa iindlela zokulinganisa ekujoliswe kuzo zisebenzisa "idatha yehlabathi lokwenyani" (RWD), njengedatha ye-EHR. Izibonelelo ze-RWD zibandakanya ukufika ngexesha, ukuhla, kunye nokubonakalisa iipatheni zonyango kukhathalelo oluqhelekileyo, kodwa kufuneka zilinganiswe kwimiba yomgangatho wedatha, kubandakanywa idatha elahlekileyo, ukuchongwa okungachanekanga nokungahambelani kunye nenkcazo yeempawu zabathathi-nxaxheba kunye neziphumo, ulawulo olungaguqukiyo lonyango, ukuphindaphinda okuhlukeneyo kovavanyo olulandelwayo, kunye nokulahlekelwa kokufikelela kwiinkqubo ezahlukeneyo zezempilo ngenxa yokudluliselwa kweenkqubo zempilo ezithatha inxaxheba. Uphononongo lwe-VA lusebenzise idatha evela kwi-EHR enye, eyanciphisa iinkxalabo zethu malunga nokungahambelani kwedatha. Nangona kunjalo, ukuqinisekiswa okungaphelelanga kunye namaxwebhu ezibonakaliso, kubandakanywa ne-comorbidities kunye neziphumo, kuhlala kuyingozi.
Ukukhethwa kwabathathi-nxaxheba kwiisampuli zokuhlalutya kudla ngokusekwe kwidatha ye-retrospective, enokukhokelela ekukhetheni ukhetho ngokungabandakanyi abantu abanolwazi olusisiseko olulahlekileyo. Ngelixa ezi ngxaki zingazodwa kwizifundo zoqwalaselo, ziyimithombo yotyekelo olushiyekileyo ekujoliswe kulo ukulinganisa kolingo olungenako ukujongana ngqo. Ukongeza, amaphononongo oqwalaselo ahlala engabhaliswanga kwangaphambili, nto leyo eyenza mandundu imiba efana nobuntununtunu boyilo kunye nokuthambekela kokupapasha. Ngenxa yokuba imithombo eyahlukeneyo yedatha, uyilo, kunye neendlela zokuhlalutya zinokuvelisa iziphumo ezahlukeneyo kakhulu, uyilo lokufunda, indlela yokuhlalutya, kunye nesiseko sokukhethwa komthombo wedatha kufuneka kumiselwe kwangaphambili.

Kukho izikhokelo zokuqhuba kunye nokunika ingxelo ngezifundo kusetyenziswa isakhelo sokulinganisa solingo ekujoliswe kuso esiphucula umgangatho wophononongo kwaye siqinisekise ukuba ingxelo ineenkcukacha ngokwaneleyo ukuze umfundi ayiphonononge ngokunzulu. Okokuqala, iiprothokholi zophando kunye ne-SAP kufuneka zilungiswe kwangaphambili ngaphambi kokuhlalutya idatha. I-SAP kufuneka ibandakanye iindlela zeenkcukacha-manani ezicacileyo zokujongana ne-bias ngenxa ye-confounders, kunye nokuhlalutya uvakalelo lokuvavanya ukuqina kweziphumo ngokuchasene nemithombo emikhulu ye-bias efana ne-confounders kunye nedatha engekhoyo.

Amacandelo esihloko, abstract, kunye neendlela kufuneka ayenze icace into yokuba uyilo lophononongo luphononongo lokuqwalasela ukuphepha ukubhideka kunye ne-RCTS, kwaye kufuneka yahlule phakathi kwezifundo zoqwalaselo eziye zaqhutywa kunye nezilingo ezicingelwayo ezizanywayo ukuxelisa. Umphandi kufuneka achaze imilinganiselo yomgangatho njengomthombo wedatha, ukuthembeka kunye nokunyaniseka kwezinto zedatha, kwaye, ukuba kunokwenzeka, dwelisa ezinye izifundo ezipapashiweyo usebenzisa umthombo wedatha. Umphandi kufuneka kwakhona anikeze itheyibhile echaza izinto zoyilo lovavanyo olujoliswe kuyo kunye nokulinganisa kwayo okuqwalaselwayo, kunye nenkcazo ecacileyo yexesha lokugqiba ukufaneleka, ukuqalisa ukulandelwa, kunye nokwabela unyango.
Kwizifundo ezisebenzisa ukulinganisa kovavanyo olujoliswe kuyo, apho isicwangciso sonyango asinakumiselwa kwisiseko (njengezifundo ngexesha lonyango okanye ukusetyenziswa konyango oludibeneyo), isisombululo sokungakhethi ixesha lokufa kufuneka sichazwe. Abaphandi bafanele bachaze uhlalutyo olunentsingiselo yovakalelo lokuvavanya ukomelela kweziphumo zophando kwimithombo ephambili ye-bias, kubandakanywa ukulinganisa impembelelo enokubakho ye-confounders engabonakaliyo kunye nokuhlola utshintsho kwiziphumo xa izinto eziphambili zoyilo zisetwa ngenye indlela. Ukusetyenziswa kweziphumo zolawulo olubi (iziphumo ezingahambelani kakhulu nokuvezwa kwenkxalabo) nazo zinokunceda ukulinganisa i-bias eseleyo.

Nangona uphononongo loqwalaselo lunokuhlalutya imiba enokuthi ingenzeki ukuba iqhube i-RCTS kwaye inokuthatha inzuzo ye-RWD, izifundo zophononongo nazo zinemithombo emininzi enokubakho yokuthamba. Inkqubo yokulinganisa yolingo ekujoliswe kuyo izama ukulungisa ezinye zezi zinto zicalu-calucalulo, kodwa kufuneka ifaniswe kwaye inikwe ingxelo ngononophelo. Ngenxa yokuba i-confounders ingakhokelela kwi-bias, uhlalutyo lovakalelo kufuneka lwenziwe ukuvavanya ukuqina kweziphumo ngokuchasene nabadibanisi abangabonakaliyo, kwaye iziphumo kufuneka zitolikwe ukuba zithathele ingqalelo utshintsho kwiziphumo xa ezinye iingqikelelo zenziwe malunga nabadibanisi. Inkqubo yokulinganisa yolingo ekujoliswe kuyo, ukuba iphunyezwe ngokungqongqo, inokuba yindlela eluncedo yokuseta ngokucwangcisiweyo uyilo lophononongo loqwalaselo, kodwa ayilonyango.