“Hare-hare a kaina, a zahiri, ana kai hari ne kimiyya.” Anthony Fauci, Yuni 9, 2021 (MSNBC).
Rashin hankali.
Abu ɗaya, Dr. Fauci bai bayar da rahoto daidai ba kan tambayoyin kimiyya a duk lokacin cutar ta Covid-19. Ga wani kuma, mahimman yaren kimiyya shine jayayya, tambaya, muhawara. Ba tare da muhawara ba, kimiyya ba komai bane illa farfaganda.
Duk da haka, mutum na iya yin tambaya, ta yaya zai yiwu a gabatar da kayan fasaha ga jama'ar Amirka, idan ba ga jama'a na duniya ba, kusan shekaru uku da kuma cimma cikakkiyar fahimtar cewa al'amuran "kimiyya ne," alhali kuwa ba haka ba ne? Na tabbatar da cewa abin da aka ciyar da waɗannan jama'a ta hanyar kafofin watsa labaru na gargajiya a tsawon lokacin bala'in ya kasance mai tasiri, amma ba kimiyya ba, kuma duka jama'ar Amurka da na duniya, da kuma yawancin likitoci, da masana kimiyya da kansu, ba za su iya bambanta ba. Duk da haka, bambancin yana da mahimmanci kuma mai zurfi.
Kimiyya ta fara da ka'idoji, hasashe, waɗanda ke da ƙwaƙƙwaran ƙima. Duk da haka, waɗannan ka'idodin ba kimiyya ba ne; su motsa kimiyya. Kimiyya na faruwa ne lokacin da mutane ke yin gwaji ko yin abubuwan lura waɗanda ke da alaƙa da fa'idodi ko fa'idodin ka'idodin. Wadancan binciken sun kasance suna tallafawa ko karyata ra'ayoyin, wanda sai a canza su ko sabunta su don daidaitawa da sababbin abubuwan da aka gani ko kuma watsi da su idan hujjoji masu karfi sun nuna cewa sun kasa kwatanta yanayi. Sannan ana maimaita zagayowar. Science shine yin aikin ƙwaƙƙwaran ko na lura don samun shaidar da ke tabbatarwa ko karyata ka'idoji.
Gabaɗaya, ra'ayoyin sun kasance suna zama maganganu masu ma'ana waɗanda ke bayyana wani takamaiman wani abu game da yadda yanayi ke aiki. Lalacewa tana cikin idon mai kallo, tunda abin da ya dace ga ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun masu ilimin fasaha na iya zama ba su dace ba. Alal misali-watakila an cika shi-heliocentrism bai dace ba kafin Nicolaus Copernicus ya buga ka'idarsa a 1543, kuma ba ta da kyau sosai daga baya na ɗan lokaci kaɗan, har sai Johannes Kepler ya fahimci cewa ma'aunin astronomical da Tycho Brahe ya yi ya ba da shawarar sake gyara tsarin kewayawar Copernican da ke kewaye da jirgin sama wanda ya dace da ma'auni. ellipses-duk da haka dalilai na waɗannan ƙa'idodin lissafin, ko da sun kasance kyakkyawan bayanin motsin rai, ba su kasance masu kyau ba har sai Isaac Newton a 1687 ya nuna wanzuwar ƙarfin nauyi na duniya tsakanin talakawa, tare da ma'auni-daidaitacce, doka ta nisa mai juzu'i-square da ke kula da girman girman girman girman girman girman girman girman girman girman da kuma daidaitawa da yawa.
A gare mu a yau, da wuya mu yi tunani game da yuwuwar zawarwar tsarin hasken rana na heliocentric, saboda bayanan lura da suka shafe shekaru 335 sun yi daidai da wannan ka'idar. Amma muna iya yin baƙar magana a tunanin cewa haske yana tafiya a lokaci ɗaya kamar ɓarna da raƙuman ruwa, da kuma yin ma'auni akan hasken, abin da muke yi a matsayin masu lura, yana ƙayyade ko muna ganin halayen barbashi ko halayen igiyar ruwa, kuma za mu iya zaɓar kiyaye ko dai barbashi ko raƙuman ruwa, amma ba duka biyu a lokaci ɗaya ba. Dabi'a ba lallai ba ne abin da ya dace.
Amma duk iri ɗaya, ƙa'idodi masu dacewa suna da sauƙin gaskatawa, kuma shine matsalar. Wannan shine abin da aka ciyar da mu kusan shekaru uku na cutar ta Covid-19. A zahiri ko da yake, an ciyar da mu amintacce maimakon kimiyya na dogon lokaci.
Cargo-Cult Science
Charlatans da ke zargin suna karkatar da cokali da hankalinsu, ko kuma da'awar yin nazarin da ba za a iya tabbatarwa ba, "hangen nesa" da ba za a iya misaltawa ba sun shahara sosai a shekarun 1960 da 1970. Imani masu ban mamaki a cikin abin da “kimiyya” zai iya kafawa sun kai irin wannan matakin da physics Nobel Laureate Richard Feynman ya ba da adireshin farawa na Caltech na 1974 (Feynman, 1974) yana baƙin ciki irin waɗannan imani marasa ma'ana. Kalaman nasa ba su yi niyya ga jama'a ba, amma don yaye ɗaliban Caltech, waɗanda da yawa daga cikinsu an ƙaddara su zama masana kimiyya.
A cikin jawabinsa, Feynman ya bayyana yadda 'yan tsibirin Kudancin Tekun Kudu, bayan yakin duniya na biyu, suka kwaikwayi sojojin Amurka da ke wurin a lokacin yakin, wadanda suka jagoranci saukar jiragen sama da kayayyaki. Mazauna tsibirin, ta yin amfani da kayan gida, sun sake haifar da tsari da halayen abin da suka shaida na GI na Amurka, amma babu kayan da ya zo.
A cikin mahallin mu, batun Feynman zai kasance cewa har sai wata ka'ida ta sami tabbataccen hujjar da ke tattare da ita, ta kasance ka'idar kawai ko ta yaya za ta yi kyau ga duk wanda ya nishadantar da shi. Mutanen Tsibirin sun rasa mahimmancin gaskiyar cewa ba su fahimci yadda tsarin samar da kayayyaki ke aiki ba, duk da yadda haifuwarsu ta kasance a gare su. Cewa Feynman ya ji tilas ya gargaɗi ɗaliban Caltech da suka kammala karatunsu game da bambanci tsakanin sanin yakamata da kimiyya, yana mai nuni da cewa wannan bambamcin ba a koyo sosai a cikin ilimantar da Cibiyar su. Ba a koyar da shi sarai ba lokacin da wannan marubucin ya kasance dalibi a can a waɗannan shekarun, amma ko ta yaya, an sa ran mu koyi shi "ta osmosis."
Magani akan Shaida
Wataƙila babu wani babban abin kunya a yau fiye da "maganin shaidaGordon Guyatt ne ya kirkiro wannan kalma a cikin 1990, bayan yunkurinsa na farko, "Magungunan Kimiyya," ya kasa samun karbuwa a shekarar da ta gabata. A matsayina na masanin ilimin cututtuka na jami'a a 1991, an zagi ni da hubris da jahilci a cikin amfani da wannan kalma, EBM, kamar dai shaidar likita ta ko ta yaya "shaidar da ba ta dace ba a cikin sabon horo." na EBM (Sackett et al., 1996), kodayake yawancin wannan amsa mara kyau da alama sun dogara ne akan asarar kulawar labari maimakon nazarin haƙiƙa na abin da binciken likita ya yi a zahiri ba tare da "EBM ba."
Ilimin likitancin Yammacin Turai ya sami karbuwa na dubban shekaru. A cikin Littafi Mai Tsarki na Ibrananci (Fitowa 21:19), “Sa’ad da ɓangarori biyu suka yi husuma, ɗayan kuma ya bugi ɗayan… wanda abin ya shafa za a warkar da shi sosai” [fassara na] wanda ke nuna cewa mutanen da ke da nau'ikan ilimin likitanci sun wanzu kuma suna da ɗan tasiri. Hippocrates, a cikin karni na biyar da huɗu KZ, ya ba da shawarar cewa ci gaban cututtuka bazai zama bazuwar ba amma yana da alaƙa da fallasa daga yanayi ko zuwa wasu halaye. A wannan zamanin, akwai abubuwa da yawa a yau za mu yi la'akari da misalan misalan aikin likita mai kyau. Duk da haka, farawa ne, yin tunani game da hujjoji masu ma'ana don ilimin likita.
James Lind (1716-1794) ya ba da shawarar kariya ga scurvy ta hanyar cin citrus. An san wannan magani ga magabata, kuma musamman tun da farko likitan soja na Ingila John Woodall (1570-1643) ya ba da shawarar - amma Woodall ya yi watsi da shi. Lind ya sami yabo saboda a cikin 1747 ya gudanar da ƙaramin amma nasara ba tare da izini ba, gwajin sarrafa lemu da lemu da sauran abubuwa a cikin marasa lafiya 12 scurvy.
A cikin shekarun 1800, Edward Jenner ya yi amfani da saniya a matsayin rigakafin ƙwayar cuta ta hanyar yin amfani da wasu dabbobi da kuma amfani da shi gabaɗaya wajen barkewar annoba, ta yadda a lokacin shari'ar Kotun Koli ta 1905. Jacobson da Massachusetts, Alkalin Alkalai na iya tabbatar da cewa hukumomin kiwon lafiya sun amince da allurar cutar sankarau don zama hanyar da aka saba yarda da ita. Mujallun likitanci sun fara bugawa na yau da kullun kuma a cikin 1800s. Misali, da Lancet ya fara bugawa a cikin 1824. An fara raba ilimin likitanci da kuma yin muhawara gabaɗaya kuma a ko'ina.
Saurin ci gaba zuwa 1900s. A cikin 1914-15, Joseph Goldberger (1915) ya gudanar da gwaji na sa baki na abinci wanda ba a yarda da shi ba wanda ya kammala cewa rashin niacin na abinci ya haifar da pellagra. A cikin 1920s, an samar da allurar rigakafin diphtheria, pertussis, tarin fuka da tetanus. An fitar da insulin. An samar da bitamin, ciki har da Vitamin D don hana rickets. A cikin 1930s, an fara ƙirƙirar maganin rigakafi da amfani da su yadda ya kamata. A cikin 1940s, an samar da acetaminophen, kamar yadda ake yin chemotherapies, kuma an fara amfani da isrogen da aka haɗa don magance zafi mai zafi na menopause. Sabbin magunguna masu inganci, alluran rigakafi da na'urorin likitanci sun karu da yawa a cikin 1950s da 1960s. Duk ba tare da EBM ba.
A cikin 1996, mayar da martani ga sukar EBM, David Sackett et al. (1996) yayi ƙoƙari ya bayyana ƙa'idodinsa gaba ɗaya. Sackett ya tabbatar da cewa EBM ya biyo baya daga "Kyakkyawan likitoci suna amfani da ƙwarewar asibiti guda ɗaya da kuma mafi kyawun shaidar waje." Wannan ma'anar plausibility ce ta anodyne, amma duka bangarorin biyu kuskure ne ko aƙalla yaudara. Ta hanyar yin la'akari da wannan ma'anar dangane da abin da ya kamata likitocin guda ɗaya su yi, Sackett yana nuna cewa ya kamata ma'aikatan su yi amfani da nasu abubuwan lura na asibiti da gogewa. Koyaya, babban wakilcin shaida na ƙwarewar asibiti ɗaya na iya zama mai rauni. Kamar dai sauran nau'o'in shaida, ana buƙatar tattara bayanan asibiti bisa tsari, bita, da kuma nazarin su, don samar da haɗin gwiwar tunani na asibiti, wanda zai samar da ɓangaren asibiti na shaidar likitancin kimiyya.
Babban gazawar hujjar hujja ita ce bayanin Sackett na cewa yakamata mutum yayi amfani da “mafi kyawun shaidar waje” maimakon dukan ingantacciyar shaida ta waje. Hukunce-hukunce game da abin da ya ƙunshi “mafi kyawun shaida” suna da ƙima sosai kuma ba lallai ba ne su ba da sakamako gabaɗaya waɗanda suka fi daidai kuma daidai (Hartling et al., 2013; Bae, 2016). A cikin samar da "al'amuran" na yanzu na canonical na dalilai masu ma'ana, Sir Austin Bradford Hill (1965) bai haɗa da wani bangare na abin da zai zama shaida "mafi kyau" ba, kuma bai nuna cewa ya kamata a auna ko rarraba nazarin don "ingancin binciken" ko ma cewa wasu nau'ikan ƙirar ƙira na iya zama mafi kyau fiye da sauran ba. A cikin Littafin Magana akan Shaidar Kimiyya, Margaret Berger (2011) ta bayyana a sarari, "... da yawa daga cikin mafi kyawun girmamawa da kuma manyan masana kimiyya (irin su Hukumar Bincike kan Ciwon daji ta Duniya (IARC), Cibiyar Nazarin Magunguna, Majalisar Bincike ta Kasa, da Cibiyar Nazarin Kiwon Lafiyar Muhalli ta Kasa) suna la'akari da duk hujjojin kimiyya da suka dace, wanda aka ɗauka gaba ɗaya, don sanin wane ƙarshe ko hasashe shine mafi kyawun da'awar jiki. " Wannan shi ne ainihin hanyar Hill; An yi amfani da abubuwan da ya sa na dalilin dalili fiye da shekaru 50 don yin tunani daga kallo zuwa dalili, a kimiyya da shari'a. Wannan EBM an tsara shi ne akan zaɓen “mafi kyaun” shaida ta zahiri hanya ce mai yuwuwa amma ba ta kimiyya ba.
A tsawon lokaci, tsarin EBM don zaɓin la'akari da "mafi kyawun shaida" da alama an "ƙasasshe," da farko ta hanyar sanya gwaje-gwajen da bazuwar (RCTs) a saman dala na duk ƙirar binciken kamar yadda ake tsammani "daidaitaccen ma'aunin zinare", kuma daga baya, a matsayin nau'in binciken kawai wanda za'a iya amincewa da shi don samun ƙididdiga marasa son kai. Duk sauran nau'o'in shaida na ƙwaƙƙwara suna "mai yuwuwar son zuciya" don haka ba abin dogaro ba ne. Wannan kyakkyawan ra'ayi ne kamar yadda zan nuna a ƙasa.
Amma yana da kyau sosai cewa ana koyar da shi akai-akai a ilimin likitancin zamani, don haka yawancin likitoci suna la'akari da shaidar RCT kawai kuma suna watsi da duk wasu nau'o'in shaida. Yana da ma'ana sosai cewa wannan marubucin ya yi faɗa a kan iska tare da wani mai sharhi a talabijin mara ilimin likitanci wanda ya ba da wata shaida face ƙwarewa (Whelan, 2020): Shin ba "a bayyane yake ba" cewa idan kun ba da izinin batutuwa, kowane bambance-bambancen dole ne ya haifar da maganin, kuma babu wasu nau'ikan karatu da za a iya amincewa da su? A bayyane, i; gaskiya, a'a.
Wanene ya amfana daga tafin kafa, mai da hankali kan sha'awar RCT? RCTs suna da tsada sosai don gudanar da su idan za su kasance masu inganci ta hanyar annoba da isassun ƙididdiga. Za su iya kashe miliyoyin ko dubun-dubatar daloli, wanda ke iyakance roƙon su ga kamfanoni da ke haɓaka samfuran likitanci da wataƙila za su iya kawo ribar da ta fi wannan tsadar. A tarihi, kula da kantin magani da yin amfani da shaidar RCT a cikin tsarin tsari ya ba da babban haɓakawa a cikin ikon tura samfuran ta hanyar amincewar ka'ida a cikin kasuwa, kuma dalilin yin hakan har yanzu yana ci gaba a yau.
Majalisar ta amince da wannan matsala, wacce ta zartar da Dokar Zamantakewar Abinci da Magunguna ta 1997 (FDAMA) wacce aka kafa a cikin 2000 ClinicalTrials.gov gidan yanar gizo don yin rajista na duk gwajin asibiti da aka yi a ƙarƙashin bincike sabbin aikace-aikacen magunguna don bincika tasirin magungunan gwaji ga marasa lafiya masu tsanani ko yanayin barazanar rai (Labarun Magunguna na Ƙasa, 2021). Don dalilai masu alaƙa da suka haɗa da rikice-rikice na sha'awa a cikin gwaje-gwajen asibiti, gidan yanar gizon ProPublica "Dollars for Docs" (Tigas et al., 2019) wanda ke rufe biyan kuɗin kamfanin na pharma ga likitoci a cikin shekarun 2009-2018 da gidan yanar gizon OpenPayments (Cibiyoyin Medicare & Medicaid Services, 2022 daga 2013) an yi su da biyan 2021. abin nema. An ƙirƙiri waɗannan tsarin bayanan ne saboda “lalacewar” wanda bazuwar bazuwar ta atomatik ke sa sakamakon binciken daidai kuma an gane rashin son zuciya a matsayin rashin isa don tinkarar binciken chicanery da dalilan rikice-rikicen sha'awa mai binciken da bai dace ba.
Duk da yake waɗannan yunƙurin gyarawa ko iyakance cin hanci da rashawa na binciken likita sun taimaka, ɓarna na shaida a ƙarƙashin sunan EBM ya ci gaba. Ɗaya daga cikin mafi munin misalai shine takarda da aka buga a cikin New England Journal of Medicine Fabrairu 13, 2020, a farkon cutar ta Covid-19, mai taken, "The Magic of Randomization with the Myth of Real-World Evidence," ta sanannun masana kididdigar likitocin Burtaniya guda huɗu waɗanda ke da alaƙa mai mahimmanci ga kamfanonin harhada magunguna (Collins et al., 2020). Wataƙila an rubuta shi a cikin Janairu 2020, kafin yawancin mutane su san cewa cutar na zuwa. Wannan takarda ta yi iƙirarin cewa bazuwar tana haifar da ƙwaƙƙwaran karatu ta atomatik, kuma duk binciken da ba a yarda da shi ba ƙaƙƙarfan shara ne. A lokacin karanta shi, na ji ya zama abin ƙyama ga dukan horo na, annoba. Nan da nan na yi fushi da shi, amma daga baya na fahimci mummunar rikice-rikice na sha'awar marubuta. Wakilin cewa kawai shaidar RCT da ba za ta iya araha ba ta dace don amincewar tsari yana ba da kayan aiki ga kamfanonin harhada magunguna don kare tsadarsu, samfuran haƙƙin mallaka masu fa'ida sosai a kan gasa ta hanyar ingantattun magungunan kashe-kashe masu tsada waɗanda masana'antun ba za su iya ba da damar manyan RCTs ba.
Randomization
Don haka, menene aibi na bazuwar abin da na yi ishara da shi, wanda ke buƙatar zurfafa bincike don fahimtar ingancin karatun RCT da sauran ƙirar binciken? Matsalar ta ta'allaka ne a cikin fahimtar rikitawa. Ruɗewa wani yanayi ne na annoba inda dangantaka tsakanin fallasa da sakamako ba saboda fallasa ba, amma zuwa abu na uku (mai rikicewa), aƙalla a wani ɓangare. Mai rikicewa yana da alaƙa ko ta yaya tare da fallasa amma ba sakamakon bayyanar ba.
A irin waɗannan lokuta, dangantakar da ke bayyana-sakamako ta kasance da gaske saboda alaƙar da ke da alaƙa. Alal misali, nazarin shan barasa da haɗarin ciwon daji na iya zama mai ruɗar da tarihin shan taba wanda ya dace da amfani da barasa (kuma ba a haifar da amfani da barasa ba) amma yana haifar da haɓakar ciwon daji. Bincike mai sauƙi na barasa da ciwon daji, yin watsi da shan taba, zai nuna dangantaka. Koyaya, da zarar an sarrafa tasirin shan taba ko daidaitawa, alaƙar barasa tare da haɗarin kansa zai ragu ko ɓacewa.
Manufar bazuwar, na daidaita duk abin da ke tsakanin magunguna da ƙungiyoyi masu sarrafawa, shine don cire yiwuwar rikicewa. Shin akwai wata hanyar da za a cire yiwuwar ruɗani? Ee: auna abubuwan da ake tambaya kuma daidaita su ko sarrafa su a cikin ƙididdigar ƙididdiga. Don haka a bayyane yake cewa bazuwar yana da fa'ida ɗaya mai yuwuwa wacce ba ta samuwa ga karatun da ba na bazuwar ba: sarrafa unauna confounders. Idan ba a fahimci alaƙar ilimin halitta, likitanci, ko cututtukan cututtukan ba game da sakamakon sha'awa, to ba za a iya auna duk abubuwan da suka dace ba, kuma wasu daga cikin waɗannan abubuwan da ba a auna su ba na iya rikitar da ƙungiyar sha'awa.
Saboda haka, randomization. a cikin ka'idar, yana kawar da yiwuwar rikicewa ta hanyar abubuwan da ba a auna su ba a matsayin bayani ga ƙungiyar da aka lura. Wannan ita ce hujjar hujja. Tambayar ko da yake ta shafi yadda bazuwar ke aiki a gaskiya, kuma wanene daidai yake buƙatar daidaitawa ta hanyar bazuwar. Gwaje-gwaje na asibiti suna amfani da bazuwar ga duk batutuwa masu shiga don ƙayyade ayyukan ƙungiyar jiyya. Idan a cikin taron sakamakon binciken mutane sun ƙunshi juzu'in jimillar binciken, to waɗannan sakamakon mutane suna buƙatar daidaitawa cikin abubuwan da suka iya haifar da rikice-rikice su ma. Misali, idan duk wadanda suka mutu a cikin rukunin jiyya maza ne kuma duk a cikin rukunin placebo mata ne, to jinsi yana iya ruɗar tasirin jiyya.
Matsalar ita ce, binciken RCT da gaske bai taɓa nuna cikakkiyar bazuwar batutuwan sakamakon su ba, kuma abin da suke ɗauka don nuna bazuwar ƙungiyoyin jiyya na su kusan koyaushe ba su da mahimmanci a kimiyyance. Wataƙila wannan matsala ta taso saboda daidaikun mutanen da ke gudanar da nazarin RCT, da masu bita da editocin mujallu waɗanda suka yi la'akari da takaddunsu, ba su da isasshen fahimtar ƙa'idodin cututtukan cututtuka.
A yawancin wallafe-wallafen RCT, masu binciken suna ba da cikakken bayanin tebur na farko na jiyya da ƙungiyoyin placebo (a matsayin ginshiƙai), vs ma'auni daban-daban (a matsayin layuka). Wato, kashi na rarraba jiyya da batutuwan placebo ta jinsi, rukuni na shekaru, kabilanci / kabilanci da dai sauransu. Shafi na uku a cikin waɗannan tebur yawanci shine p-darajar ƙididdiga don bambancin mita tsakanin jiyya da abubuwan placebo akan kowane ma'auni. A hankali magana, wannan ƙididdiga ta ƙididdige yuwuwar cewa bambancin mita tsakanin jiyya da abubuwan placebo wannan babban zai iya faruwa kwatsam. Ganin cewa an sanya batutuwan ƙungiyoyin kula da su gaba ɗaya kwatsam, ƙididdigar ƙididdiga na tsarin damar bazuwar tautological ne kuma ba shi da mahimmanci. Wannan a cikin wasu RCTs, wasu dalilai na iya bayyana sun fi matsananci fiye da damar da za su ba da izini a ƙarƙashin bazuwar kawai saboda an bincika abubuwa da yawa ƙasa da layuka don bambance-bambancen rarraba kuma a cikin irin wannan yanayi, dole ne a yi amfani da ikon ƙididdiga na kwatancen da yawa.
Abin da ake buƙata a cikin ginshiƙi na uku na teburin bayanin RCT ba p-darajar ba ne, amma ma'auni na girman girman ruɗani na musamman jere factor. Ba a auna ruɗani da yadda ya faru, amma da yadda muninsa yake. A cikin gwaninta na a matsayin mai ilimin cututtuka na sana'a, mafi kyawun ma'auni guda ɗaya na ruɗani shine canjin kashi cikin girman alaƙar sakamakon jiyya tare da mu ba tare da daidaitawa ga mai rikicewa ba. Don haka alal misali, idan tare da daidaitawa ga jinsi, jiyya yana yanke mace-mace da 25% (haɗarin dangi = 0.75), amma ba tare da daidaitawa ya yanke shi da 50% ba, to girman rikicewa ta jinsi zai zama (0.75 - 0.50) / 0.75 = 33%. Masana cututtukan cututtukan gabaɗaya suna la'akari da fiye da 10% canji tare da irin wannan daidaitawa don nuna cewa ruɗani yana nan kuma yana buƙatar sarrafawa.
Kamar yadda na lura, yawancin wallafe-wallafen RCT ba sa samar da girman ƙididdiga masu ruɗarwa ga ƙungiyoyin jiyya na gabaɗaya, kuma ba don batutuwan sakamakon su ba. Don haka ba zai yiwu a faɗi cewa batutuwan da aka samu sun yi daidai da bazuwar ga dukkan abubuwan da aka bayar a cikin jadawalin bayanin takarda. Amma yuwuwar mummunar lahani na karatun RCT, abin da zai iya sa su zama mafi kyau fiye da karatun da ba a sani ba kuma a wasu lokuta mafi muni, shi ne cewa bazuwar yana aiki ne kawai lokacin da yawancin batutuwa suka kasance bazuwar (Deaton da Cartwright, 2018), kuma wannan ya shafi musamman ga batutuwan sakamako, ba kawai ga duka binciken ba.
Yi la'akari da jujjuya tsabar kudi sau goma. Zai iya zuwa aƙalla kai bakwai da wutsiya uku, ko akasin haka, cikin sauƙi kwatsam (34%). Koyaya, girman wannan bambancin, 7/3 = 2.33, yana da yuwuwar girma sosai dangane da yiwuwar ruɗani. A gefe guda, faruwar girman girman 2.33 daga kawuna 70 ko sama da haka cikin ɓangarorin 100 zai yi wuya, p=.000078. Domin bazuwar yin aiki, akwai buƙatar samun lambobi masu yawa na abubuwan sakamako a cikin duka jiyya da ƙungiyoyin placebo, in ji 50 ko fiye a kowace ƙungiya. Wannan shi ne babban kuskuren da ba a bayyana ba na nazarin RCT wanda ya sa hujjar hujjar su ba ta da amfani, saboda nazarin RCT gabaɗaya an tsara su don samun isasshen ikon ƙididdiga don gano mahimmancin ƙididdiga na sakamakon su na farko idan jiyya ta yi aiki kamar yadda aka annabta, amma ba a tsara su don samun cikakkun batutuwan sakamako ba don rage yiwuwar rikicewa zuwa kasa da 10% ce.
Ana iya ganin muhimmin misali na wannan batun a cikin ingantaccen sakamakon RCT da aka buga na farko don rigakafin Pfizer BNT162b2 mRNA Covid-19 (Polack et al., 2020). An yi la'akari da wannan binciken babban isa (43,548 mahalarta bazuwar) kuma yana da mahimmanci (Covid-19) wanda saboda tunaninsa na RCT ya sami damar bugawa a cikin "mafi daraja" New England Journal of Medicine. Sakamakon farko na binciken shine faruwar Covid-19 tare da farawa aƙalla kwanaki bakwai bayan kashi na biyu na rigakafin ko allurar placebo. Duk da haka, yayin da ya lura da lokuta 162 a cikin batutuwan placebo, wanda ya isa don bazuwar bazuwar, ya sami lokuta takwas kawai a cikin batutuwan rigakafin, babu inda kusan isa ga bazuwar don yin wani abu don sarrafa rikice-rikice.
Daga kwarewar cututtukan cututtukan gabaɗaya, ƙwaƙƙwaran dangi haɗarin wannan babban (kimanin 162/8 = 20) ba zai yuwu ba gaba ɗaya ya kasance saboda ruɗani, amma daidaiton haɗarin dangi ko tasirinsa ((20 – 1)/20 = 95%) yana cikin shakka. An lura cewa wannan maganin da ake amfani da shi ba zai zama tasiri ba wajen rage haɗarin kamuwa da cuta ba abin mamaki ba ne idan aka ba da raunin sakamakon binciken saboda rashin isasshen samfurin don tabbatar da cewa bazuwar ya yi aiki ga batutuwan sakamako a cikin duka jiyya da ƙungiyoyin placebo.
Wannan "nutsewa cikin ciyawa" na cututtukan cututtuka ya haskaka dalilin da yasa binciken RCT tare da ƙasa da, ka ce, batutuwan sakamako na 50 a cikin kowane ɗayan jiyya na gwaji ba shi da wani da'awar don guje wa yiwuwar rikicewa ta hanyar abubuwan da ba a auna ba. Amma kuma yana bayyana dalilin da ya sa irin wannan gwaji na iya zama mafi muni Fiye da gwajin sarrafawa mara izini na bayyanar da sakamako iri ɗaya. A cikin gwaje-gwajen da ba a ba da izini ba, masu bincike sun san cewa abubuwa da yawa na iya, kamar yadda zai yiwu masu rikicewa, suna rinjayar abin da ya faru na sakamakon, don haka suna auna duk abin da suke tunanin ya dace, don daidaitawa da sarrafa waɗannan abubuwan a cikin ƙididdigar ƙididdiga.
Koyaya, a cikin RCTs, masu bincike akai-akai suna tunanin cewa bazuwar ya yi nasara kuma don haka aiwatar da ƙididdigar ƙididdiga marasa daidaituwa, yana ba da sakamako mai ruɗani. Lokacin da kuka ga RCTs da aka nuna a matsayin nazarin "manyan" saboda dubban dubban mahalarta, duba abin da ya wuce, zuwa adadin abubuwan da suka faru na farko a cikin maganin makamai na gwaji. Gwaji tare da ƙananan lambobi na abubuwan da suka faru na farko ba su da amfani kuma bai kamata a buga su ba, balle a dogara da lafiyar jama'a ko la'akari da manufofi.
Hujja Tabbaci
Bayan karanta duk abubuwan da suka gabata, za ku iya tunanin cewa waɗannan gardama game da bazuwar da gwaje-gwajen da ba a ba da izini ba suna da ma'ana sosai, amma menene game da hujjojin da za su goyi bayansu? Don haka, an gudanar da cikakken bincike ta Cochrane Library Database of Reviews System (Anglemyer et al., 2014). Wannan binciken ya bincika cikakkun bayanai na littattafan lantarki guda bakwai na tsawon lokaci daga Janairu 1990 zuwa Disamba 2013, don gano duk takaddun bita na yau da kullun waɗanda aka kwatanta da "ƙididdigar girman tasirin ƙididdiga masu ƙididdige inganci ko tasirin ayyukan da aka gwada a cikin gwaje-gwajen [bazuwar] tare da waɗanda aka gwada a cikin binciken binciken." A cikin tasirin meta-bincike na meta-bincike, binciken ya haɗa da dubban kwatancen binciken mutum ɗaya kamar yadda aka taƙaita cikin takaddun bita guda 14.
Layin ƙasa: matsakaicin kawai 8% bambanci (95% iyakokin amincewa, -4% zuwa 22%, ba ƙididdiga ba) tsakanin RCTs da daidaitattun sakamakon gwajin da ba a yarda da su ba. A taƙaice, wannan rukunin ilimin - ƙwararru da kuma wanda ya dogara da ka'idodin annoba - ya nuna cewa, sabanin abin da ake kira "lalacewa," gwaje-gwajen da bazuwar ba su da matsayi na atomatik a matsayin ma'auni na zinariya na shaidar likita ko a matsayin kawai nau'i na shaidar likita, da kuma cewa kowane binciken yana buƙatar a yi nazari sosai kuma a haƙiƙa don bincikar ƙarfinsa da raunin ƙarfi da ƙarfi ga nasa ƙarfi da ƙarancin ƙarfi.
Sauran Abubuwan Halaye
A yayin bala'in cutar ta Covid-19, an yi amfani da wasu ikirari da yawa na shaidar kimiyya don tabbatar da manufofin kiwon lafiyar jama'a, gami da ayyana cutar ta gaggawa da kanta. Ƙarƙashin da yawa daga cikin waɗannan sun kasance tabbatacce amma ƙa'ida ce mai fa'ida cewa makasudin kula da cutar ta hanyar kiwon lafiyar jama'a shine rage adadin mutanen da suka kamu da kwayar cutar ta SARS-CoV-2.
Wannan manufar na iya zama kamar a bayyane, amma ba daidai ba ne a matsayin manufar bargo. Abin da ya kamata a rage shi shine illar cutar. Idan kamuwa da cuta ya haifar da alamu marasa daɗi ko masu ban haushi ga yawancin mutane amma babu wani matsala mai tsanani ko na dogon lokaci - kamar yadda yake faruwa ga SARS-CoV-2, musamman a zamanin Omicron - to ba za a sami fa'ida ta zahiri ba na gabaɗayan ayyukan kiwon lafiyar jama'a da iyakokin da ke keta haƙƙin halitta ko tattalin arziƙin irin waɗannan mutane da haifar da lahani a kansu.
Al'ummomin Yammacin Turai, gami da Amurka, suna ɗaukar raƙuman kamuwa da cututtukan numfashi na shekara-shekara a cikin tafiya ba tare da ayyana bala'in bala'in cutar ba, duk da cewa suna haifar da miliyoyin masu kamuwa da cuta a kowace shekara, saboda ana ɗaukar sakamakon kamuwa da cuta gabaɗaya a cikin likitanci, har ma da ba da izini ga dubun-dubatar mutuwa kowace shekara.
An kafa shi a cikin 'yan watannin farko na cutar ta Covid-19 cewa haɗarin mace-macen kamuwa da cuta ya bambanta da fiye da ninki 1,000 a tsawon shekaru, kuma mutanen da ba su da yanayin kiwon lafiya na yau da kullun kamar su ciwon sukari, kiba, cututtukan zuciya, cututtukan koda, tarihin kansa da sauransu, suna cikin haɗarin mutuwa da ƙarancin haɗarin asibiti. A wannan lokacin, ya kasance mai sauƙi don ayyana nau'ikan mutane masu haɗari waɗanda a matsakaici za su ci gajiyar ayyukan kula da lafiyar jama'a, da waɗanda ba su da haɗari waɗanda za su sami nasarar shawo kan kamuwa da cuta ba tare da lamurra masu fa'ida ko dogon lokaci ba. Don haka, tsarin kula da cutar mai cike da raɗaɗi, mai girman-daya-daidai-duk wanda bai bambanta nau'ikan haɗari ba ya da ma'ana kuma mai zalunci tun daga farko.
Saboda haka, matakan da aka inganta ta hanyar yin la'akari don rage yaduwar kamuwa da cuta, ko da sun kasance masu tasiri don wannan dalili, ba su yi aiki mai kyau na magance cutar ba. Waɗannan matakan duk da haka ba su taɓa samun barata ta hanyar shaidar kimiyya ba tun farko. Dokokin Nisantar Jama'a ta Kafa Shida wani tsari ne na sabani na CDC (Dangor, 2021). Da'awar fa'ida don sanya abin rufe fuska ba da wuya ya bambanta fa'ida ga mai sawa ba - wanda irin wannan suturar zai zama zaɓi na mutum ko don karɓar ƙarin haɗarin ka'idar - vs fa'ida ga masu kallo, abin da ake kira "ikon tushe," inda za a iya amfani da la'akari da lafiyar jama'a da kyau. Nazarin tushen tushen abin rufe fuska don ƙwayoyin cuta na numfashi, inda binciken ba shi da lahani mai mutuwa, bai nuna wani fa'ida mai fa'ida ba wajen rage watsa kamuwa da cuta (Alexander, 2021; Alexander, 2022; Burns, 2022).
Ba a taɓa yin amfani da kulle-kullen jama'a gabaɗaya a cikin ƙasashen Yamma ba kuma ba su da wata shaida ta tasiri don yin wani abu banda jinkirta abin da ba makawa (Meunier, 2020), kamar yadda bayanan yawan jama'ar Ostiraliya suka bayyana (Worldometer, 2022). A cikin tabbatacciyar tattaunawa game da matakan kiwon lafiyar jama'a don shawo kan cutar mura (Inglesby et al., 2006), marubutan sun ce, "Babu wani bincike na tarihi ko binciken kimiyya wanda ke tallafawa tsarewa ta hanyar keɓe ƙungiyoyin masu kamuwa da cuta na tsawon lokaci don rage yaduwar mura. Ƙungiyar Rubuce ta Hukumar Lafiya ta Duniya (WHO), bayan nazarin wallafe-wallafen da kuma yin la'akari da kwarewar duniya ta zamani, ta kammala da cewa' tilasta warewa da keɓewa. Mummunan sakamakon keɓe masu girma dabam yana da matuƙar girma (tilasta tilasta wa marasa lafiya rijiya; cikakken taƙaita zirga-zirgar jama'a; wahalar samun kayayyaki masu mahimmanci, magunguna, da abinci ga mutanen da ke cikin yankin keɓe) don haka ya kamata a kawar da wannan matakin daga cikin la'akari sosai."
A kan ƙuntatawa tafiye-tafiye, Inglesby et al. (2006) lura, "Hanyoyin tafiye-tafiye, irin su rufe filayen jirgin sama da duba matafiya a kan iyakoki, a tarihi ba su da tasiri. Kungiyar Rubuce ta Hukumar Lafiya ta Duniya ta kammala da cewa 'bincike da keɓe masu shiga matafiya a kan iyakokin ƙasa da ƙasa ba su jinkirta gabatarwar cutar ba a cikin cututtukan da suka gabata ... Wani bincike daga Isra'ila ya ba da rahoton raguwar cututtukan mura bayan yajin aikin makonni 2006, amma raguwar ta bayyana ne kawai na kwana ɗaya, lokacin da makarantu suka rufe don hutun hunturu a lokacin bala'in 2 a Chicago, 'mafi yawan kamuwa da mura ya tashi a tsakanin ɗalibai.
Wannan tattaunawar ta bayyana a sarari cewa waɗannan ayyukan da ake zaton suna yin katsalandan ga watsa kwayar cutar bisa la'akari da dalilai masu tasiri don tasirin su duka biyun sun ɓace don sarrafa cutar, kuma ba a tabbatar da su ta hanyar shaidar kimiyya na tasiri wajen rage yaɗuwar ba. Babban haɓakarsu ya nuna gazawar manufofin kiwon lafiyar jama'a a zamanin Covid-19.
Plausibility vs Bad Science
Ana iya yin jayayya cewa manufofin kiwon lafiyar jama'a daban-daban da kuma bayanan da aka bayar ga jama'a ba su sami goyan bayan fahimi ba amma a maimakon haka ta hanyar kimiyya mara kyau ko aibi, suna nunawa a matsayin kimiyya na gaske. Misali, a cikin gidanta, mujallar da ba ta yi nazari ba, Rahotanni na Mako-mako na Ciwo da Mutuwa, CDC ta wallafa adadin nazarin tasirin maganin alurar riga kafi. Waɗannan rahotannin sun bayyana nazarin ɓoyayyiyar ɓangarori amma sun yi nazarin su kamar dai sun kasance nazarce-nazarce, ta hanyar yin amfani da ƙididdigan ma'auni na ƙima maimakon haɗarin dangi don ƙididdige tasirin rigakafin. Lokacin da sakamakon binciken ba safai ba, a ce ƙasa da 10% na batutuwan karatu, to, ƙimar rashin daidaituwa na iya kusantar haɗarin dangi, amma in ba haka ba, ƙimar rashin daidaituwa yakan zama ƙima. Koyaya, a cikin karatun sashe na giciye, ana iya ƙididdige haɗarin dangi kai tsaye kuma ana iya daidaita su don yuwuwar rikice-rikice ta hanyar haɓakar haɗarin dangi (Wacholder, 1986), kama da yin amfani da juzu'i na logistic a cikin binciken sarrafa shari'a.
Misalin wakilci shine nazarin tasirin maganin Covid-19 kashi na uku (Tenforde et al., 2022). A cikin wannan binciken, "... Cibiyar sadarwa ta IVY ta yi rajistar manya 4,094 masu shekaru ≥18," kuma bayan abubuwan da suka dace, "An haɗa majinyatan asibiti 2,952 (marasa lafiya 1,385 da 1,567 marasa COVID-19 sarrafawa)." Nazarin sassan-ta hanyar ƙira-bayyana jimlar batutuwan batutuwa, yayin da lambobin shari'o'i da sarrafawa, da fallasa kuma ba a bayyana ba, suna faruwa a waje da sa hannun mai bincike, watau, ta kowace irin tsarin yanayin da ke ƙarƙashin tsarin likitanci, ilimin halitta da cututtukan cututtukan da ke ƙarƙashin jarrabawa. Ta zaɓar jimillar batutuwa, Tenforde et al. nazarin shine ta ma'anar ƙirar giciye. Wannan binciken ya ba da rahoton tasirin maganin rigakafi na 82% tsakanin marasa lafiya ba tare da yanayin rigakafi ba. Wannan ƙididdigewa yana nuna daidaitaccen rabon rashin daidaituwa na 1 - 0.82 = 0.18. Koyaya, kashi 31 cikin 70 na marasa lafiya a cikin waɗanda aka yi wa alurar riga kafi, kuma daga cikin waɗanda ba a yi musu allurar ba akwai kashi 3 cikin ɗari, babu wanda ba ya isa ya isa ya ba da izinin yin amfani da ƙimar ƙimar ƙima don ƙididdige tasirin maganin. Ta lambobi a cikin rahoton binciken Tebura 0.45, Ina ƙididdige haɗarin dangin da ba a daidaita ba na 0.43 da kusan haɗarin dangi da aka daidaita na 1, yana ba da tasirin rigakafin gaske na 0.43 - 57 = 82% wanda ya bambanta sosai kuma ya fi muni fiye da XNUMX% da aka gabatar a cikin takarda.
A cikin wani mahallin daban, bayan na buga wani taƙaitaccen labarin bita kan amfani da hydroxychloroquine (HCQ) don farkon jiyya na Covid-19 (Risch, 2020), an buga wasu takaddun gwaji na asibiti a ƙoƙarin nuna cewa HCQ ba ta da tasiri. Na farko daga cikin waɗannan abubuwan da ake kira "karkatawa" an gudanar da su a cikin marasa lafiya na asibiti, wanda cutar ta kusan bambanta a cikin ilimin cututtuka da magani fiye da rashin lafiya na farko (Park et al., 2020). Mahimman sakamakon da na yi magana a cikin bita na, haɗarin asibiti da mace-mace, sun shagala a cikin waɗannan ayyukan ta hanyar mayar da hankali kan sakamako na ainihi da ƙananan kamar tsawon lokacin gwajin ƙwayar cuta, ko tsawon zaman asibiti.
Daga baya, an fara buga RCTs na amfani da HCQ na waje. Wani abin al'ada shi ne na Caleb Skipper et al. (2020). Babban mahimmin ƙarshen wannan gwaji shine sauyi a cikin gabaɗayan cutar da aka ba da rahoton kai a cikin kwanaki 14. Wannan maƙasudin ƙarshen ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙa'idodin ba su da mahimmancin cutar, musamman idan aka ba da batutuwan da ke cikin binciken wannan rukunin bincike sun sami matsakaicin iya faɗi ko suna cikin HCQ ko placebo makamai na gwaji (Rajasingham et al., 2021) kuma don haka sakamakon da aka ba da rahoton kai ba duk abin da ya makantar da makamai ba. Daga nazarin kididdigar su, marubutan sun kammala daidai da cewa "Hydroxychloroquine bai rage tsananin cutar ba a cikin marasa lafiya da wuri, mai sauƙi na COVID-19." Koyaya, manyan kafofin watsa labarai sun ba da rahoton wannan binciken a matsayin nuna cewa "hydroxychloroquine baya aiki." Misali, Jen Christensen (2020) in CNN Lafiya Ya bayyana game da wannan binciken, "Magungunan maganin zazzabin cizon sauro hydroxychloroquine bai amfana da marasa lafiya marasa lafiya da ke da alamun Covid-19 masu sauƙi waɗanda aka yi musu magani da wuri a lokacin kamuwa da su, a cewar wani binciken da aka buga ranar Alhamis a cikin mujallar kiwon lafiya. Annals na Internal Medicine. "
Amma a gaskiya ma, binciken Skipper ya ba da rahoto game da sakamakon biyu na mahimmanci, haɗarin asibiti da mace-mace: tare da placebo, asibiti 10 da mutuwar 1; tare da HCQ, asibiti 4 da mutuwa 1. Waɗannan lambobin suna nuna raguwar 60% na haɗarin asibiti wanda, kodayake ba a ƙididdigewa ba (p=0.11), gabaɗaya ya dace da duk sauran nazarin haɗarin asibiti don amfani da HCQ a cikin marasa lafiya (Risch, 2021). Duk da haka, waɗannan ƙananan lambobi na abubuwan da suka faru ba su kusan isa don bazuwar don daidaita kowane abu ba, kuma binciken ba shi da amfani a kan wannan. Amma har yanzu an yi kuskuren fassara shi a cikin wallafe-wallafen da ke nuna cewa HCQ ba ta da fa'ida a amfani da marasa lafiya.
karshe
Yawancin sauran lamura na ƙwaƙƙwaran kimiyya ko mugun kimiyya sun faru yayin bala'in Covid-19. Kamar yadda aka gani tare da takaddun Surgisphere da aka janye, mujallolin likitanci na yau da kullun kuma suna buga wannan shirme ba tare da soki ba idan dai ƙarshe ya yi daidai da manufofin gwamnati. Hukumar NSC, FDA, CDC, NIH, WHO, Wellcome Trust, AMA, hukumomin kiwon lafiya na jihohi da na gida, kamfanonin harhada magunguna na kasa da kasa da sauran kungiyoyi a duniya da suka keta hakkinsu ga jama'a ko kuma da gangan suka zaɓi rashin fahimtar kimiyyar karya.
Majalisar dattijan Amurka kwanan nan ta kada kuri'a, a karo na uku, don kawo karshen dokar ta-baci ta Covid-19, duk da haka Shugaba Biden ya ce zai yi watsi da matakin saboda "tsoron" na maimaituwa. lambobi. Ni da abokan aikina mun yi gardama kusan shekara guda da ta gabata cewa bala'in bala'in ya ƙare (Risch et al., 2022), amma duk da haka dogaro mai ƙima kan shari'ar da ake ƙirga don tabbatar da murkushe haƙƙin ɗan adam a ƙarƙashin murfin "gaggawa" yana ci gaba da ƙarewa.
Tsanani mai yawa daga kafofin watsa labaru na gargajiya da kuma yawancin kafofin watsa labarun ya toshe mafi yawan maganganun jama'a game da wannan mummunar kimiyya da karya. Cece-kuce kayan aiki ne na wanda ba za a iya karewa ba, tunda ingantaccen kimiyya yana kare kansa. Har sai jama'a sun fara fahimtar bambanci tsakanin fahimta da kimiyya da kuma yadda aka yi ƙoƙari sosai don samar da "samfurin" kimiyya da yawa wanda yayi kama da kimiyya amma ba haka ba, tsarin zai ci gaba kuma shugabannin da ke neman ikon mulki za su ci gaba da dogara da shi don hujjar karya.
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Harvey Risch, Babban Masanin Kimiyya a Cibiyar Brownstone, likita ne kuma Farfesa Emeritus na Epidemiology a Makarantar Yale na Kiwon Lafiyar Jama'a da Makarantar Magungunan Yale. Babban sha'awar bincikensa shine ilimin ilimin ciwon daji, rigakafi da ganewar asali, da kuma hanyoyin cututtukan cututtuka.
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