amakuru

Ibigeragezo byemewe (RCTS) nibipimo bya zahabu mugusuzuma umutekano nibikorwa byubuvuzi. Icyakora, rimwe na rimwe, RCT ntabwo ishoboka, bityo intiti zimwe zashyizeho uburyo bwo gutegura ubushakashatsi bwo kwitegereza hakurikijwe ihame rya RCT, ni ukuvuga, binyuze mu “kugerageza kwigana intego”, ubushakashatsi bwo kwitegereza bwigana muri RCT kugira ngo bugire agaciro.

Ibigeragezo byemewe byemewe (RCTS) nibipimo byo gusuzuma umutekano ugereranije nibikorwa byubuvuzi. Nubwo isesengura ryamakuru yaturutse mu bushakashatsi bw’ibyorezo n’ububiko bw’ubuvuzi (harimo n’ubuvuzi bwa elegitoroniki [EHR] hamwe n’ubuvuzi bw’ubuvuzi) bufite ibyiza by’ubunini bw'icyitegererezo, kubona amakuru ku gihe, ndetse n'ubushobozi bwo gusuzuma ingaruka “isi nyayo”, iri sesengura rikunda kubogama ryangiza imbaraga z'ibimenyetso batanga. Kuva kera, hasabwe gukora ubushakashatsi bwo kwitegereza ukurikije amahame ya RCT kugirango tunonosore ibyagaragaye. Hariho uburyo butandukanye bwuburyo bugerageza gukuramo imyanzuro yatanzwe namakuru yo kwitegereza, kandi umubare munini wabashakashatsi barimo kwigana igishushanyo mbonera cy’ubushakashatsi bwo kureba kuri hypothetical RCTS binyuze mu “kwigana intego.”

Intego yo kwigana igerageza isaba ko igishushanyo nisesengura ryubushakashatsi bwitegereza bihuza na hypothetical RCTS ikemura ikibazo kimwe cyubushakashatsi. Mugihe ubu buryo butanga uburyo bunoze bwo gushushanya, gusesengura, no gutanga raporo bifite ubushobozi bwo kuzamura ireme ry’ubushakashatsi bwo kureba, ubushakashatsi bwakozwe muri ubu buryo buracyafite aho bubogamiye buturuka ahantu henshi, harimo n’ingaruka ziteye urujijo zituruka kuri covariates. Ubushakashatsi nkubu busaba ibishushanyo mbonera, uburyo bwo gusesengura kugirango bikemure ibintu bitera urujijo, na raporo zisesengura.
Mu bushakashatsi bwifashishije uburyo bwo kwigana intego-yo kugerageza, abashakashatsi bashizeho hypothetical RCTS yakorwa neza kugirango bakemure ikibazo runaka cyubushakashatsi, hanyuma bashireho ibishushanyo mbonera byubushakashatsi bujyanye nibyo "test-test" RCTS. Ibishushanyo mbonera bikenewe birimo gushyiramo ibipimo byo guhezwa, guhitamo abitabiriye amahugurwa, ingamba zo kuvura, inshingano zo kuvura, gutangira no kurangiza kubikurikirana, ingamba zavuyemo, gusuzuma neza, na gahunda yo gusesengura imibare (SAP). Kurugero, Dickerman n'abandi. yakoresheje uburyo bwo kwigana-kugerageza no gukoresha amakuru ya EHR yo muri Minisiteri ishinzwe ibibazo by’abasirikare muri Amerika (VA) kugira ngo agereranye akamaro k’inkingo za BNT162b2 na mRNA-1273 mu gukumira indwara zanduza SARS-CoV-2, ibitaro, n’impfu.

Urufunguzo rwo kwigana ikigeragezo cyateganijwe ni ugushiraho “igihe zeru,” ingingo isuzumirwa abitabiriye amahugurwa basuzumwa, kuvurwa, no gukurikiranwa. Mu bushakashatsi bw’inkingo VA Covid-19, igihe zeru cyasobanuwe nkitariki ya dose yambere yinkingo. Guhuza igihe cyo kumenya ibyangombwa, kugenera ubuvuzi, no gutangira gukurikirana kugeza kuri zeru bigabanya inkomoko yingenzi yo kubogama, cyane cyane kubogama kubudapfa muguhitamo ingamba zo kuvura nyuma yo gutangira kubikurikirana, no guhitamo kubogama mugutangira gukurikirana nyuma yo gutanga ubuvuzi. Kuri VA
Mu bushakashatsi bw’inkingo ya Covid-19, niba abitabiriye amahugurwa bahawe itsinda ry’ubuvuzi kugira ngo basesengure hashingiwe ku gihe bakiriye ikinini cya kabiri cy’urukingo, kandi gukurikirana byatangijwe mu gihe cy’igipimo cya mbere cy’urukingo, habayeho kubogama igihe cyo gupfa; Niba itsinda rishinzwe kuvura ryashinzwe mugihe cyumuti wambere winkingo hanyuma gukurikirana bigatangira mugihe cyumuti wa kabiri winkingo, havuka kubogama kuberako abahawe inshuro ebyiri zinkingo bazaba barimo.

Intego yo kugerageza igereranya nayo ifasha kwirinda ibihe aho ingaruka zo kuvura zidasobanuwe neza, ingorane zisanzwe mubushakashatsi bwo kureba. Mu bushakashatsi bw’urukingo rwa VA Covid-19, abashakashatsi bahuje abitabiriye amahugurwa bashingiye ku miterere y’ibanze kandi basuzuma uburyo bwo kuvura bushingiye ku itandukaniro ry’ingaruka ziterwa n’ibyumweru 24. Ubu buryo busobanura neza igereranya ryimikorere nkibinyuranyo mubisubizo bya Covid-19 hagati yabaturage bakingiwe bafite ibipimo fatizo byuzuye, bisa nibigereranyo bya RCT kubibazo bimwe. Nkuko abanditsi b’ubushakashatsi babigaragaje, kugereranya ibyavuye mu nkingo ebyiri zisa bishobora kutagerwaho n’impamvu ziteye urujijo kuruta kugereranya ibyavuye mu nkingo n’inkingo.

Nubwo ibintu byahujwe neza na RCTS, agaciro k'ubushakashatsi ukoresheje intego-yo kugerageza kwigana biterwa no guhitamo ibitekerezo, gushushanya no gusesengura, hamwe n'ubwiza bw'amakuru ashingiye. Nubwo agaciro k'ibisubizo bya RCT nako gashingiye ku bwiza bw'igishushanyo n'isesengura, ibisubizo by'ubushakashatsi bwo kureba nabyo byugarijwe n'impamvu zitesha umutwe. Nkubushakashatsi butabigenewe, ubushakashatsi bwo kwitegereza ntibukingiwe ibintu bitera urujijo nka RCTS, kandi abitabiriye amahugurwa n’abaganga ntabwo ari impumyi, ibyo bikaba bishobora kugira ingaruka ku isuzuma ry’ibisubizo ndetse n’ibisubizo by’ubushakashatsi. Mu bushakashatsi bw’urukingo rwa VA Covid-19, abashakashatsi bifashishije uburyo bwo guhuza igabana ry’imiterere y’ibanze by’amatsinda yombi yitabiriye amahugurwa, harimo imyaka, igitsina, ubwoko, ndetse n’urwego rw’imijyi batuyemo. Itandukaniro mugukwirakwiza ibindi biranga, nkakazi, birashobora kandi kuba bifitanye isano ningaruka zo kwandura Covid-19 kandi bizaba ibisigisigi.

Ubushakashatsi bwinshi ukoresheje uburyo-bwo kugerageza kwigana bukoresha "amakuru yisi yose" (RWD), nka data ya EHR. Inyungu za RWD zirimo kuba igihe, kugipimo, no kwerekana uburyo bwo kuvura mubuvuzi busanzwe, ariko bigomba gupimwa kubibazo byubuziranenge bwamakuru, harimo kubura amakuru, kutamenya neza no guhuza ibimenyetso biranga abitabiriye amahugurwa n’ibisubizo, imiyoborere idahwitse y’ubuvuzi, inshuro zitandukanye z’isuzumabumenyi, ndetse no kubura uburyo bwo kwimura abitabiriye gahunda zitandukanye z’ubuzima. Ubushakashatsi bwa VA bwakoresheje amakuru yo muri EHR imwe, yagabanije impungenge zacu kubijyanye no guhuza amakuru. Nyamara, kwemeza kutuzuye hamwe ninyandiko zerekana ibipimo, harimo ingaruka nibisubizo, bikomeje kuba akaga.
Guhitamo abitabiriye icyitegererezo cyisesengura akenshi bishingiye kumibare isubira inyuma, ishobora kuganisha ku guhitamo kubogamye ukuyemo abantu babuze amakuru yibanze. Nubwo ibyo bibazo bidasanzwe gusa mubushakashatsi bwo kwitegereza, ni isoko yo kubogama gusigara kugereranywa nikigereranyo ntigishobora gukemurwa. Byongeye kandi, ubushakashatsi bwo kwitegereza akenshi ntabwo bwanditswe mbere, bwongera ibibazo nkibishushanyo mbonera no kubogama. Kuberako amakuru atandukanye, ibishushanyo, nuburyo bwo gusesengura bishobora gutanga ibisubizo bitandukanye cyane, igishushanyo mbonera, uburyo bwo gusesengura, hamwe namakuru yatoranijwe agomba kugenwa mbere.

Hariho umurongo ngenderwaho wo kuyobora no gutanga raporo ukoresheje uburyo bwo kugerageza kwigana intego yo kuzamura ireme ryubushakashatsi no kwemeza ko raporo irambuye bihagije kugirango abasomyi bayisuzume neza. Ubwa mbere, protocole yubushakashatsi na SAP bigomba gutegurwa hakiri kare mbere yisesengura ryamakuru. SAP igomba gushyiramo uburyo burambuye bwibarurishamibare kugirango ikemure kubogama bitewe nurujijo, hamwe nisesengura ryibyiyumvo byo gusuzuma imbaraga z ibisubizo bivuye kumasoko akomeye yo kubogama nko kwitiranya amakuru no kubura amakuru.

Umutwe, ibisobanuro, nuburyo bukwiye bigomba kumvikanisha neza ko igishushanyo mbonera cy’ubushakashatsi ari ubushakashatsi bwo kureba kugira ngo wirinde kwitiranya RCTS, kandi bugomba gutandukanya ubushakashatsi bwo kwitegereza bwakozwe n’ibigereranyo bya hypothettike bigerageza kwigana. Umushakashatsi agomba kwerekana ingamba zujuje ubuziranenge nkisoko yamakuru, kwizerwa no kwemeza ibintu byamakuru, kandi, niba bishoboka, andika ubundi bushakashatsi bwatangajwe ukoresheje isoko yamakuru. Umushakashatsi agomba kandi gutanga imbonerahamwe yerekana ibishushanyo mbonera by’urubanza rwateganijwe hamwe n’ikigereranyo cyarwo, ndetse no kwerekana neza igihe cyo kumenya ibyangombwa, gutangiza gukurikirana, no gutanga ubuvuzi.
Mu bushakashatsi ukoresheje ibigereranyo bigerageza, aho ingamba zo kuvura zidashobora kugenwa ku murongo fatizo (nk'ubushakashatsi ku gihe cyo kwivuza cyangwa gukoresha imiti ivura), hagomba gusobanurwa icyemezo cyo kubogama igihe kitari urupfu. Abashakashatsi bagomba kwerekana isesengura rifite ireme kugira ngo basuzume imbaraga z’ibisubizo by’ubushakashatsi ku masoko y'ingenzi yo kubogama, harimo no kugereranya ingaruka zishobora guterwa no kwitiranya ibintu no gushakisha impinduka mu bisubizo igihe ibintu by'ingenzi byashizweho ubundi. Gukoresha ibisubizo bibi byo kugenzura (ibisubizo bitajyanye cyane no guhura nimpungenge) birashobora kandi gufasha kubara kubogama gusigaye.

Nubwo ubushakashatsi bwo kureba bushobora gusesengura ibibazo bidashoboka gukora RCTS kandi bishobora kwifashisha RWD, ubushakashatsi bwo kureba nabwo bufite amasoko menshi yo kubogama. Intego yo kugerageza kwigana igerageza gukemura bimwe muribi, ariko bigomba kwigana no gutanga raporo neza. Kuberako abitiranya ibintu bishobora kuganisha ku kubogama, isesengura ryibyiyumvo bigomba gukorwa kugirango hamenyekane imbaraga z ibisubizo kubirwanya bitarebwa, kandi ibisubizo bigomba gusobanurwa hitawe kubihinduka mubisubizo mugihe ibindi bitekerezo byatanzwe kubyerekeye urujijo. Intego yo kugerageza kwigana, niba ishyizwe mubikorwa, irashobora kuba uburyo bwingirakamaro mugushiraho gahunda yo kwiga ibyitegererezo, ariko ntabwo ari ikibazo.