SARS-CoV-2 virusu kolay ve h\u0131zla yay\u0131lma g\u00fcc\u00fc ile bir anda k\u00fcresel bir halk sa\u011fl\u0131\u011f\u0131 sorununa d\u00f6n\u00fc\u015fm\u00fc\u015f, sosyal ve ekonomik ya\u015fam\u0131 da olumsuz etkilemi\u015ftir. \u00dc\u00e7\u00fcnc\u00fc y\u0131l\u0131n\u0131 tamamlamaya yakla\u015ft\u0131\u011f\u0131m\u0131z COVID-19 pandemisi halen en \u00f6nemli morbidite ve mortalite nedenlerinin ba\u015f\u0131nda gelmektedir. Di\u011fer yanda bilimsel ara\u015ft\u0131rma ve yay\u0131n say\u0131s\u0131ndaki art\u0131\u015f pandeminin sa\u011fl\u0131k alan\u0131nda yaratt\u0131\u011f\u0131 \u00f6nemli ve olumlu bir etki olarak ortaya \u00e7\u0131km\u0131\u015ft\u0131r. Ekonomik destekler sayesinde ba\u015fta a\u015f\u0131 olmak \u00fczere pek \u00e7ok bulu\u015f yap\u0131lm\u0131\u015f, hasta takibinin yan\u0131 s\u0131ra temel ve klinik bilimlerde \u00f6nemli geli\u015fmeler hayata ge\u00e7mi\u015ftir. Pandemi d\u00f6neminde yay\u0131nlara eri\u015fimin h\u0131zl\u0131 olmas\u0131 ve bulgular\u0131n erken d\u00f6nemde yayg\u0131n olarak bilim camias\u0131na iletilmesi klinisyenler ve politika yap\u0131c\u0131lar i\u00e7in temel veri girdisini olu\u015fturmu\u015ftur. T\u0131p ve sa\u011fl\u0131k bilimleri alan\u0131nda \u00e7\u0131kan bilimsel dergilerin \u00f6nemli bir k\u0131sm\u0131 da erken yay\u0131n, \u00e7evrim i\u00e7i yay\u0131nc\u0131l\u0131k ve a\u00e7\u0131k eri\u015fim y\u00f6ntemlerinin yan\u0131 s\u0131ra h\u0131zland\u0131r\u0131lan de\u011ferlendirme basamaklar\u0131 ile ara\u015ft\u0131rma sonu\u00e7lar\u0131n\u0131 haftalar-aylar i\u00e7inde okuyucuya ula\u015fabilir hale getirmi\u015ftir. Hatta, hakem de\u011ferlendirmesi yap\u0131lmam\u0131\u015f \u00e7al\u0131\u015fmalar dahi erken d\u00f6nemde okunabilir hale gelmi\u015ftir. Bilim d\u00fcnyas\u0131 ve pandemi s\u00fcrecini y\u00f6neten karar vericiler \u015f\u00fcphesiz bu h\u0131zl\u0131 ve eri\u015filebilir s\u00fcre\u00e7ten \u00e7ok yararlanm\u0131\u015ft\u0131r. Ancak, ya\u015fanan bu s\u00fcre\u00e7te yay\u0131ndan \u00e7ekilen, yay\u0131n sonras\u0131 d\u00fczeltme yap\u0131lan ve\/veya edit\u00f6re mektup ile k\u0131s\u0131tl\u0131l\u0131klar\u0131na dikkat \u00e7ekilen makale say\u0131s\u0131 da az\u0131msanamayacak say\u0131dad\u0131r. Y\u00fcksek etki fakt\u00f6rl\u00fc dergiler ba\u015fta olmak \u00fczere \u00e7ok say\u0131da dergi yazarlardan \u00e7al\u0131\u015fmalar\u0131n\u0131 yay\u0131mlanma kriterlerine uygun olarak haz\u0131rlamas\u0131n\u0131 istemi\u015f olmakla birlikte i\u00e7sel ge\u00e7erlilik (kapsam ve g\u00fcvenirlik) yap\u0131s\u0131ndaki olas\u0131 eksiklikler bu h\u0131zl\u0131 yay\u0131m s\u00fcrecinde her zaman d\u00fczeltilebilmi\u015f de\u011fildir.<\/p>\n
Bilimsel yay\u0131nlar\u0131n y\u00f6ntemsel olarak de\u011ferlendirilmesi amac\u0131yla haz\u0131rlanan bu derlemede; COVID-19 pandemisi boyunca ulusal ve uluslararas\u0131 hakemli dergilerde yay\u0131mlanan, \u00e7ok say\u0131da okuyucunun ilgisini \u00e7eken, ulusal eylem planlar\u0131na yol g\u00f6steren, kitlesel uygulamalar i\u00e7in kaynak olarak kullan\u0131lan makalelere ba\u011fl\u0131 kalarak yayg\u0131n g\u00f6zlenen, d\u00fczeltilmesi durumunda \u00e7al\u0131\u015fman\u0131n veri kalitesini y\u00fckseltebilecek konulara ve ortak eksikliklere dikkat \u00e7ekmek hedeflenmi\u015ftir. Bu yakla\u015f\u0131mla, ileride yap\u0131lacak ve sonu\u00e7lar\u0131n\u0131n kullan\u0131lmas\u0131 olas\u0131 COVID-19 ili\u015fkili yay\u0131nlar\u0131n epidemiyolojik veri kalitesini iyile\u015ftirmeye yard\u0131mc\u0131 olman\u0131n yan\u0131 s\u0131ra \u00e7al\u0131\u015fma bulgular\u0131n\u0131n ge\u00e7erli ve g\u00fcvenilir olmamas\u0131 durumunda sa\u011fl\u0131k politika ve uygulamalar\u0131n\u0131n ve\/veya infekte ki\u015filerin bak\u0131m\u0131n\u0131n olumsuz etkilenmesini \u00f6nlemek m\u00fcmk\u00fcn olabilecektir. T\u0131p ve sa\u011fl\u0131k bilimleri alan\u0131nda yap\u0131lan \u00e7al\u0131\u015fmalar\u0131n yay\u0131n haline getirilmesi s\u00fcre\u00e7lerinde ele\u015ftirel okuma yakla\u015f\u0131m\u0131n\u0131n kritik \u00f6neme sahip oldu\u011fu bilinmekle birlikte h\u0131zl\u0131 yay\u0131n yapma motivasyonunun metodolojik hatalara ve eksikliklere neden olmas\u0131n\u0131n \u00f6n\u00fcne ge\u00e7ebilmek i\u00e7in neler yap\u0131labilece\u011fini tart\u0131\u015fmak bilimsel yay\u0131nlara \u015f\u00fcphesiz katk\u0131 sa\u011flayacakt\u0131r.<\/p>\n
\u0130kincil veri analizlerinde ve elektronik kay\u0131t sistemi \u00fczerinden yap\u0131lan \u00e7al\u0131\u015fmalarda daha belirgin olmak \u00fczere, tan\u0131mlay\u0131c\u0131 \u00f6zelli\u011fi a\u011f\u0131rl\u0131kl\u0131 \u00e7al\u0131\u015fmalarda kay\u0131ta ba\u011fl\u0131 eksiklik ve heterojenite, \u00f6rneklem b\u00fcy\u00fckl\u00fc\u011f\u00fcn\u00fcn yetersiz olmas\u0131, istatistiksel analizlerde hasta gruplar\u0131n\u0131n olas\u0131 kar\u0131\u015ft\u0131r\u0131c\u0131 fakt\u00f6rler a\u00e7\u0131s\u0131ndan yeterince incelenmemesi gibi sorunlar t\u0131p ve sa\u011fl\u0131k bilimlerindeki ara\u015ft\u0131rmalar\u0131n her d\u00f6nemde \u00f6nemli k\u0131s\u0131tl\u0131l\u0131klar\u0131 olmu\u015ftur.\u00a0<\/span><\/p>\n Bunlara ek olarak, COVID-19 pandemisi s\u00fcrecinde; infeksiyonun s\u00fcrekli de\u011fi\u015fen ve\/veya zaman i\u00e7inde yeni tespit edilen \u00f6zelliklerinin olmas\u0131, tan\u0131 ve tedavi s\u00fcrecindeki heterojenite, hastal\u0131k ve\/veya a\u015f\u0131lama sonras\u0131 ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131n\u0131n tam ve do\u011fru bir \u015fekilde de\u011ferlendirilememesi, ba\u011f\u0131\u015f\u0131kl\u0131ktaki zamana ba\u011f\u0131ml\u0131 azalma, heterolog a\u015f\u0131 uygulamalar\u0131, \u00fclkelerin nonfarmas\u00f6tik korunma y\u00f6ntemlerine uyumdaki\u00a0 <\/span>farkl\u0131l\u0131klar gibi durumlar ortaya \u00e7\u0131km\u0131\u015ft\u0131r. Bu nedenle zaman zaman \u00e7al\u0131\u015fmalar\u0131n planlanmas\u0131 ve analizinde yeterli ve standart bir y\u00f6ntem geli\u015ftirilemedi\u011fi i\u00e7in benzer \u00e7al\u0131\u015fmalar\u0131n bulgular\u0131nda bile farkl\u0131l\u0131k ya\u015fanm\u0131\u015f; \u00e7o\u011fu zaman, ara\u015ft\u0131rma y\u00f6ntemlerinden kaynakl\u0131 sorunlar, bu sorunlar\u0131n nedenleri ve nas\u0131l d\u00fczeltilebilece\u011fi yeterince tart\u0131\u015f\u0131l(a)mam\u0131\u015ft\u0131r.\u00a0<\/span><\/p>\n Bu derlemede, pandemi d\u00f6neminde yap\u0131lan yay\u0131nlardaki hatalardan yola \u00e7\u0131karak yeni yap\u0131lacak \u00e7al\u0131\u015fmalar i\u00e7in yararl\u0131 olaca\u011f\u0131 d\u00fc\u015f\u00fcn\u00fclen ara\u015ft\u0131rma y\u00f6ntemlerine ili\u015fkin konular ba\u015fl\u0131klar halinde verilmi\u015ftir. \u00c7ok merkezli \u00e7al\u0131\u015fmalar\u0131n yan\u0131 s\u0131ra pek \u00e7ok bilimsel alandan gelen uzman\u0131n i\u015fbirli\u011fi ile yay\u0131ma haz\u0131rlanan makalelerin; CARE, STROBE, CONSORT, PRISMA vb. rehberlerin kriterlerine uygun olarak haz\u0131rlanmas\u0131 standardize etmek a\u00e7\u0131s\u0131ndan yararl\u0131 olmakla birlikte tek ba\u015f\u0131na yeterli de\u011fildir (1). Bilimsel \u00e7al\u0131\u015fmalar\u0131n; planlama, veri toplama ve analiz a\u015famalar\u0131nda uygun ara\u015ft\u0131rma y\u00f6ntemlerinin kullan\u0131lmas\u0131 kritik \u00f6neme sahiptir. Ge\u00e7erlili\u011fi ve genellenebilirli\u011fi d\u00fc\u015f\u00fck bir \u00e7al\u0131\u015fma standart kurallara uygun olarak yaz\u0131lsa dahi ara\u015ft\u0131rma y\u00f6ntemlerine hakim bir okuyucu hatalar\u0131 ve eksiklikleri g\u00f6rebilir; ancak \u00f6zellikle politika yap\u0131c\u0131lar\u0131n i\u00e7erik ve ara\u015ft\u0131rma y\u00f6ntemlerine uygunluktan ziyade \u00e7\u0131kan\u00a0 <\/span>\u201csonu\u00e7\u201d \u00fczerinden karar vermeleri s\u0131kl\u0131kla kar\u015f\u0131la\u015f\u0131lan bir durumdur.<\/p>\n Derlemede bahsi ge\u00e7en ara\u015ft\u0131rma y\u00f6ntemi hatalar\u0131na yay\u0131mlanm\u0131\u015f \u00e7al\u0131\u015fmalar \u00fczerinden \u00f6rnek verilmesi etik olarak uygun olmad\u0131\u011f\u0131 i\u00e7in okuyucular\u0131n a\u015fa\u011f\u0131da ba\u015fl\u0131klar halinde sunulan tart\u0131\u015fmalardan yararlanmas\u0131 beklenmektedir. Ara\u015ft\u0131rmac\u0131lar\u0131n, derlemede yer verilen veya verilemeyen hatalarla kar\u015f\u0131la\u015ft\u0131k\u00e7a, bunlar\u0131 kaydetmeleri ve \u00e7e\u015fitli bilimsel faaliyet ortamlar\u0131nda tart\u0131\u015fmalar\u0131 mesleki geli\u015fimimiz ve bilime katk\u0131 a\u00e7\u0131s\u0131ndan \u015f\u00fcphesiz yararl\u0131 olacakt\u0131r.<\/p>\n NIH (\u201cNational Institutes of Health\u201d) alt\u0131nda faaliyet g\u00f6steren NLM (\u201cNational Library of Medicine\u201d)\u2019nin giri\u015fimi olan <\/i>LitCovid, COVID-19 hakk\u0131nda g\u00fcncel bilimsel bilgilere ve literat\u00fcre h\u0131zl\u0131 bir \u015fekilde eri\u015fimin sa\u011fland\u0131\u011f\u0131 elektronik ortamda haz\u0131rlanm\u0131\u015f bir alanyaz\u0131n a\u011f\u0131d\u0131r (2). S\u00f6z konusu a\u011fda, 22 Eyl\u00fcl 2022 tarihi itibariyle mekanizma, bula\u015fma, tan\u0131, tedavi, \u00f6nleme, uzam\u0131\u015f COVID-19, olgu sunumu ve tahmin olarak tan\u0131mlanm\u0131\u015f sekiz ana ba\u015fl\u0131kta COVID-19 ili\u015fkili 290 334 adet yay\u0131nlanm\u0131\u015f makale eri\u015filebilir durumda olup \u00f6zet b\u00f6l\u00fcmde T\u00fcrkiye ad\u0131 ge\u00e7en toplam 1538 makale mevcuttur. En \u00e7ok yay\u0131n yapan ilk be\u015f \u00fclke d\u00f6n\u00fc\u015f\u00fcml\u00fc olarak; ABD, \u0130ngiltere, \u00c7in, \u0130talya, Japonya, Hindistan ve Brezilya\u2019d\u0131r (2). Yay\u0131mlanm\u0131\u015f makalelerin \u00f6nemli bir k\u0131sm\u0131, \u00f6zellikle ilk 6 ay i\u00e7inde, tan\u0131mlay\u0131c\u0131 \u00f6zellikte olup prospektif, retrospektif, kesitsel, olgu-kontrol ve kohort ba\u015fl\u0131klar\u0131 ile sunulmu\u015ftur.\u00a0<\/span><\/p>\n Baz\u0131 durumlarda bir makalede kullan\u0131lan y\u00f6ntemle tan\u0131mlanm\u0131\u015f \u00e7al\u0131\u015fma tasar\u0131m\u0131n\u0131n \u00f6rt\u00fc\u015fmedi\u011fi g\u00f6r\u00fclebilir. \u00d6rne\u011fin, kar\u015f\u0131la\u015ft\u0131rma grubu olan tan\u0131mlay\u0131c\u0131 \u00e7al\u0131\u015fmalar\u0131n s\u0131kl\u0131kla olgu-kontrol tasar\u0131m\u0131 olarak ve prospektif ya da retrospektif gibi veri toplama a\u015famalar\u0131n\u0131n \u00e7al\u0131\u015fma tasar\u0131m\u0131 \u015feklinde sunulmas\u0131 s\u0131kl\u0131kla kar\u015f\u0131la\u015f\u0131lan hatalard\u0131r.\u00a0 <\/span>Di\u011fer yanda hasta gruplar\u0131na ait daha \u00f6nceden kay\u0131t alt\u0131na al\u0131nm\u0131\u015f verilerle yap\u0131lan \u00e7al\u0131\u015fmalar\u0131n; sonu\u00e7 olu\u015fmadan incelemeye al\u0131nm\u0131\u015f ortak \u00f6zellikteki ki\u015fileri kapsayan, tam muayene\/tetkik sonras\u0131 etkenle kar\u015f\u0131la\u015fma durumlar\u0131n\u0131n standartlara uygun olarak \u00f6l\u00e7\u00fcld\u00fc\u011f\u00fc, \u00f6nceden belirlenmi\u015f izlem ve periyodik s\u00fcre\u00e7lerle de\u011ferlendirmelerin yap\u0131ld\u0131\u011f\u0131, ba\u011f\u0131ml\u0131 de\u011fi\u015fkenin benzer \u015fekilde tayin edildi\u011fi kohort \u00e7al\u0131\u015fmalar gibi tan\u0131t\u0131lmas\u0131 da s\u0131kl\u0131kla g\u00f6r\u00fclmektedir.\u00a0<\/span><\/span><\/p>\n Prospektif \u00e7al\u0131\u015fma y\u00f6ntemi, ileriye d\u00f6n\u00fck olarak ve ki\u015filerin sonu\u00e7 geli\u015fme a\u00e7\u0131s\u0131ndan takibe al\u0131nmas\u0131n\u0131 ifade etmesine ra\u011fmen ki\u015filerin verilerinin toplamas\u0131yla s\u0131n\u0131rl\u0131 olacak \u015fekilde kullan\u0131labilmektedir. S\u00f6z konusu \u00e7al\u0131\u015fmalarda, prospektif \u00e7al\u0131\u015fma y\u00f6nteminin temel getirisi olan k\u00fcm\u00fclatif insidans, insidans h\u0131z\u0131 vb. \u00f6l\u00e7\u00fctlerin hesaplanmas\u0131 ve\/veya ki\u015filerin erken \u00f6l\u00fcmleri\/\u00e7al\u0131\u015fma gruplar\u0131ndan \u00e7\u0131kmalar\u0131 (sans\u00fcrlenmi\u015f g\u00f6zlem), s\u00fcre\u00e7 i\u00e7indeki COVID-19 infeksiyonu, korunma y\u00f6ntemleri, medikal uygulamalar vb. ba\u011f\u0131ml\u0131 de\u011fi\u015fken \u00fczerinden takibin olas\u0131 olmad\u0131\u011f\u0131 durumlar\u0131 dikkate almam\u0131\u015flard\u0131r (3).<\/p>\n T\u0131p ve sa\u011fl\u0131k bilimleri alan\u0131nda yaz\u0131lm\u0131\u015f makalelerde; ba\u015fl\u0131k, \u00f6zet ve y\u00f6ntem b\u00f6l\u00fcmlerinde \u00e7al\u0131\u015fma tasar\u0131m\u0131n\u0131n belirtilmesi uygun olur. Ayr\u0131ca, \u00e7al\u0131\u015fmadan hangi epidemiyolojik \u00f6l\u00e7\u00fctlerin hesaplanabilece\u011finin yan\u0131 s\u0131ra bulgular\u0131n i\u00e7 ve d\u0131\u015f ge\u00e7erlili\u011fi \u00e7al\u0131\u015fma tasar\u0131m\u0131 ile do\u011frudan ili\u015fkili oldu\u011fu i\u00e7in \u00f6rneklem hacmi, kontrol se\u00e7imi, sonu\u00e7 belirlenmesi, izlemde kay\u0131plar\u0131n kontrol\u00fc vb. unsurlar\u0131n verildi\u011fi ara\u015ft\u0131rma tasar\u0131m\u0131 detaylar\u0131n\u0131n belirtilmesi \u00f6nemlidir. \u00d6zetle, \u00e7al\u0131\u015fma tasar\u0131m\u0131, bulgular\u0131n nas\u0131l de\u011ferlendirilebilece\u011fi ve veri kalitesi a\u00e7\u0131s\u0131ndan son derece \u00f6nemli oldu\u011fu i\u00e7in makalelerde mutlaka belirtilmeli; ger\u00e7ekle\u015ftirilen uygulama i\u00e7eri\u011fi de belirtilen tasar\u0131m gereksinimlerini kar\u015f\u0131lar nitelikte olmal\u0131d\u0131r <\/i>(1, 3).<\/p>\n Baz\u0131 durumlarda, bir \u00e7al\u0131\u015fma tasar\u0131m\u0131\u00a0 <\/span>ifade edilenden farkl\u0131d\u0131r. \u00d6rne\u011fin, hasta grubu ile d\u0131\u015fsal kar\u015f\u0131la\u015ft\u0131rma grubunun al\u0131nd\u0131\u011f\u0131 bir \u00e7al\u0131\u015fma olgu-kontrol \u015feklinde analiz edilmi\u015ftir. Oysa bu iki grup ger\u00e7ekte, iki farkl\u0131 olgu serisi olup kar\u015f\u0131la\u015ft\u0131rmal\u0131 bir tan\u0131mlay\u0131c\u0131 (\u201cdescriptive\u201d) \u00e7al\u0131\u015fma niteli\u011findedir. Her ne kadar hipotez geli\u015ftirebilmek i\u00e7in \u201codds ratio\u201d (OR) hesaplamalar\u0131 yap\u0131labilse de kontrol grubunun olgulara benzer \u00f6zellikte se\u00e7ilmemi\u015f olmas\u0131 nedeniyle ba\u011f\u0131ml\u0131 ve ba\u011f\u0131ms\u0131z de\u011fi\u015fkenler aras\u0131ndaki ili\u015fki (asosyasyon) de\u011ferlerinin ge\u00e7erlili\u011fi d\u00fc\u015f\u00fckt\u00fcr. \u00d6rneklem say\u0131s\u0131, kontrollerin say\u0131 ve se\u00e7imi, etkenle kar\u015f\u0131la\u015fma \u00f6zelliklerinin olgular ile ayn\u0131 \u015fekilde ve sonu\u00e7 de\u011fi\u015fkeni a\u00e7\u0131s\u0131ndan [\u00f6rne\u011fin, \u201cpolymerase chain reaction\u201d (PCR) testi vb. ki\u015fi beyan\u0131] ve zaman ekseninde kar\u015f\u0131la\u015ft\u0131r\u0131labilir \u015fekilde belirlenmesi olgu-kontrol ara\u015ft\u0131rmalar\u0131nda belirleyici \u00f6zelliklerdir (3). Olgu-kontrol ara\u015ft\u0131rmalar<\/i>\u0131 ile kar\u015f\u0131la\u015ft\u0131rma grubu olan tan\u0131mlay\u0131c\u0131 ara\u015ft\u0131rmalar kar\u0131\u015ft\u0131r\u0131lmamal\u0131d\u0131r. <\/i>Olgu-kontrol ara\u015ft\u0131rmalar\u0131nda e\u011fer bir e\u015fle\u015ftirme varsa analizlerin uygun \u015fekilde e\u015fle\u015ftirilmi\u015f \u00f6rnekler i\u00e7in yap\u0131lmas\u0131 sa\u011flanmal\u0131, OR (ya da uygun tasar\u0131mlarla elde edilen r\u00f6latif risk) de\u011feri kar\u015f\u0131l\u0131klar\u0131 nedensellik tart\u0131\u015fmas\u0131 a\u00e7\u0131s\u0131ndan dikkatle irdelenmelidir (1, 3).<\/span><\/p>\n Kohort ara\u015ft\u0131rmalar\u0131nda; izlem s\u00fcresinin yeterli olmamas\u0131<\/i>, s\u00fcre\u00e7 i\u00e7inde etkenle kar\u015f\u0131la\u015fma durumuna g\u00f6re [iki farkl\u0131 a\u015f\u0131, hat\u0131rlatma dozu (\u201cbooster dose\u201d), primer a\u015f\u0131 serisi ile a\u015f\u0131lama uygulamalar\u0131 vb.] elde edilen sonucun ayn\u0131 olmamas\u0131, test eri\u015fimleri, fark\u0131ndal\u0131k, vb. farkl\u0131l\u0131klar veri analizini k\u0131s\u0131tlamakta ve \u00e7eli\u015fkili sonu\u00e7lara neden olabilmektedir. \u00d6l\u00e7\u00fcme ba\u011fl\u0131 olan bu farkl\u0131l\u0131klar (\u201cinformation bias\u201d) sonu\u00e7lar\u0131n kar\u015f\u0131la\u015ft\u0131r\u0131labilirli\u011fini engellemektedir (3, 4). \u00d6zellikle a\u015f\u0131 etkisi incelemelerinde, a\u015f\u0131lar\u0131n etkili olmas\u0131 beklenen a\u015famadan itibaren yap\u0131lan kar\u015f\u0131la\u015ft\u0131rmalarda, kar\u015f\u0131la\u015ft\u0131r\u0131lan a\u015f\u0131n\u0131n piyasaya \u00e7\u0131kma zaman\u0131 ayn\u0131 de\u011filse takip s\u00fcreleri kar\u015f\u0131la\u015ft\u0131r\u0131labilir k\u0131l\u0131nmal\u0131d\u0131r. Hat\u0131rlatma dozu uygulamalar\u0131n\u0131n etkilerinin de\u011ferlendirildi\u011fi bir \u00e7al\u0131\u015fmada; iki doz CoronaVac a\u015f\u0131s\u0131 olmu\u015f ki\u015filer ikinci dozdan 14 g\u00fcn sonra,\u00a0 <\/span>\u00fc\u00e7 doz a\u015f\u0131 uygulananlar ise \u00fc\u00e7\u00fcnc\u00fc dozdan 14 g\u00fcn sonra izleme al\u0131nm\u0131\u015f ve bu iki grup kar\u015f\u0131la\u015ft\u0131r\u0131lm\u0131\u015ft\u0131r. Bu yakla\u015f\u0131m, analizlerin hat\u0131rlatma dozunun etkisini vermesi a\u00e7\u0131s\u0131ndan uygun de\u011fildir. Hat\u0131rlatma dozu takvimde ka\u00e7\u0131nc\u0131 ayda \u00f6neriliyorsa (\u00f6rne\u011fin, 4. veya 6. ay) iki doz a\u015f\u0131l\u0131lar ile kar\u015f\u0131la\u015ft\u0131rma bu a\u015famadan itibaren ba\u015flat\u0131lmal\u0131d\u0131r; aksi halde hat\u0131rlatma dozu etkisi (\u00fc\u00e7\u00fcnc\u00fc doz a\u015f\u0131 t\u00fcr\u00fcnden ba\u011f\u0131ms\u0131z), oldu\u011fundan d\u00fc\u015f\u00fck g\u00f6sterilecektir (3, 5, 6).\u00a0<\/span><\/p>\n SARS-CoV-2 infeksiyonu sonras\u0131ndaki test pozitifli\u011fi, hastanede yat\u0131\u015f s\u00fcresi-hastal\u0131k \u015fiddeti\/\u00f6l\u00fcm ili\u015fkisi, hastal\u0131k\/a\u015f\u0131 sonras\u0131 ba\u011f\u0131\u015f\u0131kl\u0131k de\u011ferleri gibi bir\u00e7ok fakt\u00f6r\/ili\u015fki \u00e7al\u0131\u015fmalar\u0131nda sonu\u00e7lar\u0131n, \u00f6l\u00e7\u00fcm\u00fcn yap\u0131ld\u0131\u011f\u0131 s\u00fcre ve hastan\u0131n izleminden etkilenmesi nedeniyle farkl\u0131 \u00e7al\u0131\u015fmalara ait bulgular kar\u015f\u0131la\u015ft\u0131r\u0131lamamaktad\u0131r. Bu nedenle COVID-19 \u00e7al\u0131\u015fmalar\u0131nda, r\u00f6latif risk hesaplamalar\u0131 i\u00e7in m\u00fcmk\u00fcnse k\u00fcm\u00fclatif insidans yerine insidans (\u201chazard\u201d) h\u0131z\u0131 hesaplamalar\u0131n\u0131n tercih edilmesi yararl\u0131 olacakt\u0131r. \u0130nsidans h\u0131z\u0131 hesaplamalar\u0131nda, baz\u0131 \u00e7al\u0131\u015fmalarda ki\u015fi\/g\u00fcn, baz\u0131 \u00e7al\u0131\u015fmalarda ise ki\u015fi\/y\u0131l olarak de\u011fer verildi\u011fini g\u00f6zlemliyoruz. Bu durum uygun olmakla birlikte ki\u015fi\/g\u00fcn de\u011ferlerini ki\u015fi\/y\u0131la \u00e7evirmede hesaplama hatalar\u0131 yap\u0131lmas\u0131 maalesef nadir de\u011fildir. Ki\u015fi\/zaman hesaplamas\u0131n\u0131n amac\u0131; g\u00fcn cinsiden yap\u0131lan hesaplamadan yola \u00e7\u0131karak y\u0131ll\u0131k takipte ka\u00e7 ki\u015finin hasta olaca\u011f\u0131n\u0131 de\u011fil, farkl\u0131 ara\u015ft\u0131rmalar\u0131n \u201cger\u00e7ek<\/i>\u201d izlem s\u00fcreleri ve kat\u0131l\u0131mc\u0131 say\u0131lar\u0131n\u0131 esas alarak, paydalar\u0131n kar\u015f\u0131la\u015ft\u0131r\u0131labilir k\u0131l\u0131nmas\u0131d\u0131r. Bu yolla, benzer payda esas al\u0131nd\u0131\u011f\u0131nda ne kadarl\u0131k bir pay ile kar\u015f\u0131la\u015f\u0131laca\u011f\u0131 ortaya konarak, \u201caz\/\u00e7ok\u201d hesab\u0131 yap\u0131labilmesi hedeflenmektedir. \u00c7al\u0131\u015fmalarda kat\u0131l\u0131mc\u0131 say\u0131s\u0131 ve izlem s\u00fcresi bilgilerinin ayr\u0131ca detayland\u0131r\u0131lmas\u0131 \u00f6nemlidir; \u00f6rne\u011fin 1000 ki\u015fi\/g\u00fcn ifadesi 1000 ki\u015finin bir g\u00fcnl\u00fck izlemi veya 10 ki\u015finin 100\u2019er g\u00fcn i\u00e7in izlemine kar\u015f\u0131l\u0131k gelebilir (3).<\/p>\n \u201cPlasebo-kontroll\u00fc \u00e7al\u0131\u015fma yap\u0131lamamas\u0131 nedeniyle g\u00f6zlemsel ve a\u015f\u0131s\u0131z kontrol grubu olmayan \u00e7al\u0131\u015fmalar yap\u0131lam\u0131yor\u201d<\/span> yakla\u015f\u0131m\u0131 bilimsel a\u00e7\u0131dan uygun de\u011fildir. Ulusal kay\u0131t sisteminden; halen a\u015f\u0131s\u0131z ki\u015filer saptanabilir, takip edilebilir ve kar\u015f\u0131la\u015ft\u0131rmalarda kullan\u0131labilir. Bu nedenle, ulusal sa\u011fl\u0131k\/a\u015f\u0131 verilerinin pandemi i\u00e7inde uygun kontroller a\u00e7\u0131s\u0131ndan kullan\u0131labilmesi bir\u00e7ok \u00e7al\u0131\u015fman\u0131n gereksiz yere yap\u0131lmas\u0131n\u0131 \u00f6nleyecek ve\/veya sonu\u00e7lar\u0131n ger\u00e7ek\u00e7i de\u011ferlendirebilmesine olanak sa\u011flayacakt\u0131r (3, 7).<\/p>\n Pek \u00e7ok \u00e7al\u0131\u015fmada pop\u00fclasyon, \u00f6zel bir alandan\/kurumdan veya sadece ula\u015f\u0131labilen gruplardan (tek bir hastane, bak\u0131m evi, yo\u011fun bak\u0131m \u00fcnitesi, vb.) se\u00e7ilerek veriler elde edilmi\u015ftir. Hali haz\u0131rda toplanm\u0131\u015f verilerin kullan\u0131lmas\u0131 nedeniyle her verinin t\u00fcm kat\u0131l\u0131mc\u0131lar i\u00e7in kar\u015f\u0131l\u0131\u011f\u0131 olmamaktad\u0131r; ya\u015f, test de\u011feri, tetkikin \u00f6zelli\u011fi, vb. hususlar her kat\u0131l\u0131mc\u0131 i\u00e7in mevcut olmay\u0131p ayn\u0131 \u015fekilde \u00f6l\u00e7\u00fclmemi\u015f de olabilir. Bu nedenle s\u00f6z konusu \u00e7al\u0131\u015fmalarda, se\u00e7ime ba\u011fl\u0131 bir yan tutma<\/i> s\u00f6z konusu olup \u00e7al\u0131\u015fmaya kat\u0131lanlardan elde edilen verilerin topluma yans\u0131t\u0131lmas\u0131nda (d\u0131\u015f ge\u00e7erlilik ve genellenebilirlik) k\u0131s\u0131tl\u0131l\u0131k s\u00f6z konusudur (2, 8). Bir yandan pandemiyi y\u00f6netmek bir yandan da bilimsel ara\u015ft\u0131rmalar y\u00fcr\u00fctmek \u015f\u00fcphesiz \u00e7ok zordur. Bu anlamda, \u00c7in ba\u015fta olmak \u00fczere salg\u0131n\u0131n en yo\u011fun ya\u015fand\u0131\u011f\u0131 d\u00f6nemde klinisyenlerin hastalar\u0131 \u00fczerinden elde edilen bilgileri k\u0131sa s\u00fcrede analiz edip yay\u0131mlam\u0131\u015f olmalar\u0131, salg\u0131n\u0131 daha sonra deneyimleyen, T\u00fcrkiye gibi \u00fclkelerin klinisyenleri ve politika yap\u0131c\u0131lar\u0131 i\u00e7in \u00e7ok yararl\u0131 olmu\u015ftur. \u00d6te yandan, k\u00fc\u00e7\u00fck \u00e7apl\u0131, standart \u00f6l\u00e7\u00fcm ve uygulamaya dayal\u0131 olmayan ve\/veya genellenebilirli\u011fi d\u00fc\u015f\u00fck \u00e7al\u0131\u015fma bulgular\u0131 kullan\u0131l\u0131rken \u00e7ok dikkatli olmak gerekmektedir.<\/p>\n Pandemi s\u00fcrecinde bireysel ya\u015fam ko\u015fullar\u0131n\u0131n a\u011f\u0131rl\u0131\u011f\u0131 d\u0131\u015f\u0131nda, yo\u011fun hasta y\u00fck\u00fc ve uygun olmayan \u00e7al\u0131\u015fma ko\u015fullar\u0131 hasta kay\u0131tlar\u0131n\u0131n tam, d\u00fczenli ve standartlara uygun olarak toplanmas\u0131n\u0131 engellemi\u015f olabilir. Verilerin retrospektif olarak mevcut kay\u0131tlar \u00fczerinden topland\u0131\u011f\u0131 durumlarda, hasta bilgilerinin kapsay\u0131c\u0131l\u0131\u011f\u0131 ve g\u00fcvenilirli\u011fine ait k\u0131s\u0131tl\u0131l\u0131klar kadar, hastalar\u0131n ve klinisyenlerin izleme ve tedavi s\u00fcre\u00e7lerini b\u00fct\u00fcn\u00fcyle hat\u0131rlamalar\u0131n\u0131n (\u201crecall bias\u201d) zorluklar\u0131 da ak\u0131lda tutulmal\u0131d\u0131r.\u00a0<\/span><\/p>\n Mevcut verilerin analizi s\u00f6z konusu oldu\u011funda;<\/i> verilerin tek elden toplanmam\u0131\u015f olmas\u0131, ki\u015filerin sisteme eri\u015febilirli\u011fi\/kullanabilirli\u011fi ve\/veya bireysel tercihleri nedeni ile kat\u0131l\u0131mc\u0131 fakt\u00f6rleri \u00f6zelinde baz\u0131 kar\u0131\u015ft\u0131r\u0131c\u0131 (\u201cconfounding\u201d) fakt\u00f6rlere ili\u015fkin bilgiler toplanmam\u0131\u015f olaca\u011f\u0131 i\u00e7in, istatistiksel analizlerde olas\u0131 kar\u0131\u015ft\u0131r\u0131c\u0131 fakt\u00f6rler kontrol edilse dahi, resid\u00fcel kar\u0131\u015ft\u0131r\u0131c\u0131 etkiler nedeni ile \u00e7al\u0131\u015fman\u0131n i\u00e7 ge\u00e7erlili\u011fi (internal validitesi) ciddi \u015fekilde k\u0131s\u0131tl\u0131 olabilmektedir <\/i>(3, 8, 9).<\/p>\n A\u015f\u0131 uygulamalar\u0131 eri\u015fim kolayl\u0131\u011f\u0131 nedeniyle daha kapsay\u0131c\u0131 bir \u015fekilde sa\u011fl\u0131k personeline (\u201cconvenience sample\u201d) yap\u0131lmaktad\u0131r. Sa\u011fl\u0131k personelinin COVID-19 riskinin genel pop\u00fclasyona oranla s\u00fcrekli daha y\u00fcksek olmas\u0131 bu grupta a\u015f\u0131 \u00e7al\u0131\u015fmalar\u0131n\u0131n ba\u015far\u0131s\u0131n\u0131 oldu\u011fundan az g\u00f6sterebilir. \u00d6te yandan, bu grubun s\u00fcrekli infeksiyona maruz kalmas\u0131 a\u015f\u0131 etkisi d\u0131\u015f\u0131nda kalan antikor \u00e7al\u0131\u015fmalar\u0131nda a\u015f\u0131-kaynakl\u0131 antikor yan\u0131tlar\u0131n\u0131n oldu\u011fundan \u00e7ok g\u00f6zlenmesine neden olabilir. Maske\/mesafe\/hijyen konusundaki duyarl\u0131l\u0131k ise bu grupta a\u015f\u0131-infeksiyondan korunma ili\u015fkisini oldu\u011fundan g\u00fc\u00e7l\u00fc g\u00f6sterebilir. Di\u011fer yandan, a\u015f\u0131l\u0131 olan ve korundu\u011funa g\u00fcvenen ki\u015filer maske\/mesafe\/hijyen konusunda daha dikkatsiz davranabilirler (\u201crisk compensation\u201d); bu durumda a\u015f\u0131l\u0131 grupta koruyuculuk de\u011ferleri oldu\u011fundan d\u00fc\u015f\u00fck bulunabilir (4, 8, 9).<\/p>\n Kontrol grubunun ayn\u0131 gruptan se\u00e7ilmesi durumunda korunma fakt\u00f6r\u00fc gruplar aras\u0131nda ayr\u0131msal olmayan bir taraf tutmaya neden olaca\u011f\u0131 i\u00e7in a\u015f\u0131-korunma ili\u015fkisini oldu\u011fundan az g\u00f6sterme taraf\u0131na bir yanl\u0131l\u0131k nedeni olabilir (\u201cnon-differential bias towards the null\u201d<\/i>). A\u015f\u0131 etkililik (\u201ceffectiveness\u201d) \u00e7al\u0131\u015fmalar\u0131nda sa\u011fl\u0131k personeli ve toplumun genelinin verilerinin karma olarak de\u011ferlendirilmesi analizlerde yanl\u0131\u015f yorumlamalara neden olabilir. Bu gruplar\u0131n farkl\u0131 \u00f6zellikleri nedeniyle gruba \u00f6zel analizler ve etki b\u00fcy\u00fckl\u00fc\u011f\u00fc hesaplamalar\u0131 yap\u0131lmas\u0131 \u00f6nemlidir (4, 10).<\/p>\n Ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131n\u0131n, a\u015f\u0131dan ba\u011f\u0131ms\u0131z olarak, ya\u015f artt\u0131k\u00e7a azald\u0131\u011f\u0131 bilinmektedir. Bu durumda, 59 ya\u015f ve alt\u0131 ba\u011f\u0131\u015f\u0131kl\u0131k korumas\u0131 de\u011ferlerinin 60 ya\u015f ve \u00fczerinde ayn\u0131 olmayaca\u011f\u0131 a\u00e7\u0131kt\u0131r. A\u015f\u0131 t\u00fcrlerine g\u00f6re daha ya\u015fl\u0131 grupta sa\u011flanacak primer yan\u0131t ve azalma s\u00fcresine g\u00f6re hat\u0131rlatma dozunun t\u00fcr ve zamanlamas\u0131na mevcut \u00e7al\u0131\u015fma sonu\u00e7lar\u0131 de\u011ferlendirilirken dikkat edilmelidir (5, 6).<\/p>\n A\u015f\u0131 \u00e7al\u0131\u015fmalar\u0131n\u0131n tart\u0131\u015fma b\u00f6l\u00fcm\u00fcn\u00fcn, se\u00e7ilen \u00f6rnekleme ba\u011fl\u0131 olas\u0131 taraf tutma e\u011filiminin yan\u0131 s\u0131ra ili\u015fkili fakt\u00f6rlerin boyut, y\u00f6n, uluslararas\u0131 benzer \u00e7al\u0131\u015fma bulgular\u0131 ile kar\u015f\u0131la\u015ft\u0131rma potansiyeli ve olas\u0131 \u00e7\u00f6z\u00fcm \u00f6nerileri a\u00e7\u0131s\u0131ndan detayl\u0131 olarak irdelenmesi gerekir.<\/i><\/p>\n A\u015f\u0131 \u00f6zelinde yap\u0131lan \u00e7al\u0131\u015fmalarda; a\u015f\u0131n\u0131n t\u00fcr\u00fc, say\u0131s\u0131 ve hat\u0131rlatma dozlar\u0131n\u0131n belirlenmesi ko\u015fullar\u0131 toplumsal a\u015f\u0131lama sonu\u00e7lar\u0131nda \u00f6nemli farkl\u0131klar g\u00f6sterebilir.<\/i> \u00d6rne\u011fin \u00fclkemizde, uygulanan a\u015f\u0131 t\u00fcr\u00fcn\u00fcn se\u00e7imi her ne kadar ki\u015filerin tercihine b\u0131rak\u0131lm\u0131\u015f olsa da, ilk iki CoronaVac a\u015f\u0131 dozunun \u00f6ncelikle ya\u015fl\u0131 bireylere ve sa\u011fl\u0131k personeline uygulanm\u0131\u015f olmas\u0131, sonras\u0131nda BionTech a\u015f\u0131s\u0131n\u0131n devreye girmesi ile gen\u00e7 grupta bu a\u015f\u0131n\u0131n ya\u015fl\u0131lara k\u0131yasla primer ba\u011f\u0131\u015f\u0131klamada daha yayg\u0131n olarak kullan\u0131lmas\u0131, hat\u0131rlatma dozlar\u0131 se\u00e7ilirken ilk a\u015f\u0131lamaya uygun doz se\u00e7ilmesi veya ya\u015fl\u0131 bireylerde CoronaVac ile devam edilmesinin daha fazla \u00f6nerilmesi gibi\u00a0 <\/span>d\u0131\u015fsal kriterler ve etkiler, verilerin analizinde sadece yap\u0131lan a\u015f\u0131 \u00fczerinden de\u011ferlendirilme yap\u0131lmas\u0131n\u0131n yan\u0131 s\u0131ra se\u00e7ime ba\u011fl\u0131 olas\u0131 taraf tutma e\u011filimi nedeniyle a\u015f\u0131 koruyuculuk y\u00fczdelerinin kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131nda hataya neden olabilmektedir.\u00a0<\/span><\/p>\n Benzer \u015fekilde, zaman i\u00e7inde dola\u015f\u0131mdaki bask\u0131n olan virus varyantlar\u0131n\u0131n de\u011fi\u015fmesi ve kullan\u0131mdaki a\u015f\u0131lar\u0131n bu varyantlara olan etkisi, a\u015f\u0131lama sonras\u0131 d\u00f6nemde toplumdaki a\u015f\u0131lama y\u00fczdelerine g\u00f6re toplumun ne kadar\u0131n\u0131n korundu\u011funa ait de\u011ferin \u201czamana ba\u011fl\u0131 bir de\u011fi\u015fiklik g\u00f6stermesi\u201dne neden olacakt\u0131r. Yani a\u015f\u0131 t\u00fcr\u00fc<\/i>, ki\u015filerin hangi a\u015f\u0131lar\u0131 neden tercih etti\u011fi<\/i> ve zaman<\/i> bir b\u00fct\u00fcn olarak dikkate al\u0131nmal\u0131d\u0131r. Bu nedenle, marjinal yap\u0131sal modellemelerdekine benzer \u015fekilde; a\u015f\u0131lanma olas\u0131l\u0131klar\u0131n\u0131n tersi ile a\u011f\u0131rl\u0131kland\u0131rma (\u201cinverse probability of treatment weighting\u201d<\/i>), a\u015f\u0131 t\u00fcr\u00fc \u00fczerine kondisyonel (\u201cconditional\u201d) olmayan, a\u015f\u0131 se\u00e7imine ili\u015fkin de\u011fi\u015fkenler ve a\u015f\u0131 say\u0131lar\u0131 \u00fczerinden de\u011ferlendirmeleri de i\u00e7erecek analiz y\u00f6ntemleri kullan\u0131lmas\u0131 uygun olacakt\u0131r (11-13).<\/p>\n \u00c7al\u0131\u015fmalarda analize bir kar\u0131\u015ft\u0131r\u0131c\u0131 de\u011fi\u015fken (\u201cconfounding\u201d<\/i>) eklenecek ise bunun \u00e7al\u0131\u015f\u0131lan etkenden (\u00f6rne\u011fin a\u015f\u0131 t\u00fcr\u00fc) ba\u011f\u0131ms\u0131z olarak sonu\u00e7 de\u011fi\u015fkeni ile (\u00f6rne\u011fin, semptomatik COVID-19 infeksiyonu) ili\u015fkili olmas\u0131, sonu\u00e7tan ba\u011f\u0131ms\u0131z olarak da etken ile ili\u015fkili olmas\u0131 (\u00f6rne\u011fin hangi a\u015f\u0131n\u0131n se\u00e7ilmesi ile) ve etkenin sonuca neden oldu\u011fu yolakta (bu \u00f6rnekte ba\u011f\u0131\u015f\u0131kl\u0131k cevab\u0131, g\u00fcc\u00fc, s\u00fcresi, vb.) olmamas\u0131 gerekir. Bu nedenle, ya\u015f-a\u015f\u0131 koruyuculuk \u00e7al\u0131\u015fmalar\u0131nda ele al\u0131nan ortak bir kar\u0131\u015ft\u0131r\u0131c\u0131 de\u011fi\u015fken olup ya\u015fa g\u00f6re kontrol edilmi\u015f \u201chazard ratio\u201d (HR) veya \u201crisk ratio\u201d (RR) de\u011ferleri \u00fczerinden analizler yap\u0131lmaktad\u0131r. Bu durum, istatistiksel analiz y\u00f6ntemleri a\u00e7\u0131s\u0131ndan yanl\u0131\u015f olmamakla birlikte ya\u015f de\u011fi\u015fkeninin ki\u015filerin ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131n\u0131 do\u011frudan negatif olarak etkilemesi (\u201cimmunosenescence\u201d) ve ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131 benzer olsa dahi ya\u015f ile COVID-19 infeksiyonlar\u0131n\u0131n semptomatik seyretme s\u0131kl\u0131\u011f\u0131n\u0131n y\u00fcksek olmas\u0131 nedeniyle ya\u015f, a\u015f\u0131 koruyuculuk \u00e7al\u0131\u015fmalar\u0131nda ger\u00e7ek bir etki de\u011fi\u015ftirici unsurdur. Epidemiyolojide ayn\u0131 de\u011fi\u015fken hem etki de\u011fi\u015ftirici hem de kar\u0131\u015ft\u0131r\u0131c\u0131 rol oynayabilir. Bu durumda do\u011fru bir analitik y\u00f6ntemle, ilgili de\u011fi\u015fkeni etki de\u011fi\u015ftirici<\/i> olarak tan\u0131mlamak<\/i> ve tabakal\u0131 analizler ya da modellemede ilgili y\u00f6ntemlerle ya\u015fa \u00f6zel h\u0131zlar vermek esas al\u0131nmal\u0131d\u0131r. Bu analizler ayn\u0131 zamanda kar\u0131\u015ft\u0131r\u0131c\u0131 de\u011fi\u015fken kontrol\u00fc i\u00e7in de uygun olup ek bir analize gerek duyulmayacakt\u0131r. \u00d6te yandan, ya\u015f de\u011fi\u015fkenini kontrol etmek i\u00e7in kullan\u0131lan y\u00f6ntemlerde (Mantel-Haenzsel OR, \u201cage-adjusted\u201d <\/i>HR vb.) tek bir koruyuculuk oran\u0131 ortaya koyulabilir ve bu ya\u015f\u0131n ger\u00e7ek etkisinin de\u011ferlendirilmesini olanaks\u0131z k\u0131lar. \u00d6zetle, a\u015f\u0131 etkililik \u00e7al\u0131\u015fmalar\u0131nda ya\u015fa \u00f6zel de\u011ferlendirmeler yap\u0131lmal\u0131, farkl\u0131 koruyuculuk de\u011ferleri (%95<\/i> g\u00fcven aral\u0131klar\u0131 ile) ayr\u0131 ayr\u0131 sunulmal\u0131d\u0131r. S\u00f6z konusu analizlerde, di\u011fer olas\u0131 kar\u0131\u015ft\u0131c\u0131 de\u011fi\u015fkenler<\/i> i\u00e7in de kontrol mutlaka yap\u0131lmal\u0131d\u0131r.<\/i><\/p>\n Hat\u0131rlatma dozu etkisi de\u011ferlendirilirken, kimi \u00e7al\u0131\u015fmalarda izlem s\u00fcreleri \u00fc\u00e7 doz sonras\u0131 ile iki doz sonras\u0131 mutlak s\u00fcrelerin kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131 \u015feklinde olmaktad\u0131r. \u0130kinci a\u015f\u0131 sonras\u0131 hat\u0131rlatma dozu hemen yap\u0131lamayaca\u011f\u0131 i\u00e7in iki doz a\u015f\u0131s\u0131 bulunanlar ile hat\u0131rlatma dozu yap\u0131lanlar\u0131n kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131 daha uygun olacakt\u0131r. Bu ikinci grup sa\u011flanam\u0131yor ise en az\u0131ndan hat\u0131rlatma dozu yap\u0131labilme zaman\u0131ndan itibaren kar\u015f\u0131la\u015ft\u0131rma esas al\u0131nmal\u0131d\u0131r. Bu durumda iki doz a\u015f\u0131l\u0131larda hat\u0131rlatma dozu alanlar\u0131n almayanlara g\u00f6re etkisi<\/i> \u00e7al\u0131\u015f\u0131labilir. Dolay\u0131s\u0131yla, hat\u0131rlatma dozunun yap\u0131l\u0131p yap\u0131lmamas\u0131 gere\u011fi irdelenir. E\u011fer mutlaka iki doz a\u015f\u0131 ile \u00fc\u00e7 doz a\u015f\u0131 kar\u015f\u0131la\u015ft\u0131r\u0131lacak ise iki doz a\u015f\u0131 sonras\u0131 ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131ndaki azalma dikkate al\u0131nmal\u0131d\u0131r (5, 6).<\/p>\n \u00d6zellikle hat\u0131rlatma dozu uygulamalar\u0131nda, kar\u015f\u0131la\u015ft\u0131rma zaman\u0131 hat\u0131rlatma dozunun yap\u0131ld\u0131\u011f\u0131 tarih itibar\u0131 ile d\u00fczenlenmelidir. A\u015f\u0131 \u00e7al\u0131\u015fmalar\u0131nda, a\u015f\u0131n\u0131n koruyucu etkisi genel olarak risk oran\u0131 \u00fczerinden hesaplanm\u0131\u015f\/sunulmu\u015ftur. A\u015f\u0131n\u0131n ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131n\u0131n zaman i\u00e7inde maksimize olup ge\u00e7en s\u00fcrede azalmas\u0131 (\u201cwaning immunity\u201d<\/i>) nedeniyle ki\u015filerin izlemde kald\u0131klar\u0131 s\u00fcreler dikkate al\u0131nmal\u0131, insidans h\u0131z\u0131 oran\u0131 (\u201crate ratio\u201d)\u00a0 <\/span>m\u00fcmk\u00fcnse uyarlanm\u0131\u015f HR de\u011ferleri esas al\u0131narak de\u011ferlendirme yap\u0131lmal\u0131d\u0131r (8, 9).<\/p>\n A\u015f\u0131lama \u00e7al\u0131\u015fmalar\u0131nda sadece a\u015f\u0131 t\u00fcr\u00fc ve say\u0131s\u0131n\u0131n bilinmesi\u00a0 <\/span>korunabilirlik de\u011ferlendirmesi yapmak i\u00e7in yeterli de\u011fildir. Toplum genelinde a\u015f\u0131 sonras\u0131 bireylerin korundu\u011funu hissederek kapal\u0131 yerlere girme, maske kullanmay\u0131 azaltma <\/i>vb.<\/i> davran\u0131\u015flar (\u201crisk compensation\u201d) g\u00f6sterdi\u011fi bilinmektedir; bu durum \u00e7al\u0131\u015fmalarda a\u015f\u0131n\u0131n etkisini oldu\u011fundan az g\u00f6sterme y\u00f6n\u00fcnde hataya neden olabilir. Ayr\u0131ca toplumda baz\u0131 a\u015f\u0131lar di\u011ferlerine g\u00f6re daha koruyucu olarak alg\u0131lan\u0131yorsa, bu t\u00fcr bir hatal\u0131 yakla\u015f\u0131m nedeniyle koruyuculu\u011fu y\u00fcksek kabul edilen a\u015f\u0131 aleyhine bir etki de\u011feri sonucuna neden olacakt\u0131r (9).<\/p>\n A\u015f\u0131lar\u0131n bireyler \u00f6zelindeki koruyuculu\u011fu ve a\u015f\u0131 say\u0131lar\u0131 do\u011frudan toplumdaki durumu kestirmek i\u00e7in yeterli de\u011fildir. Topluma atfedilen risk ve koruyuculu\u011fun de\u011ferlendirilebilmesi i\u00e7in; a\u015f\u0131l\u0131 bireylere uygulanan a\u015f\u0131lar\u0131n t\u00fcr\u00fc, say\u0131s\u0131, hat\u0131rlatma dozu yap\u0131lma durumu, yap\u0131lan a\u015f\u0131lar\u0131n aras\u0131ndaki s\u00fcre, COVID-19 ge\u00e7irme durumu gibi bir\u00e7ok de\u011fi\u015fkenin e\u015f zamanl\u0131 olarak kontrol edilmesi gereklidir. Bu nedenle T.C. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131\u2019n\u0131n a\u015f\u0131 verilerinin kapsaml\u0131 bir \u015fekilde de\u011ferlendirilmesi toplumdaki a\u015f\u0131 ihtiyac\u0131n\u0131n belirlenmesi i\u00e7in kritik \u00f6neme sahiptir. Hi\u00e7bir tekil \u00e7al\u0131\u015fma ile \u00fclkedeki a\u015f\u0131 ihtiyac\u0131 belirlenemez. T.C. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131, verileri ulusal \u00e7apta, tam, d\u00fczenli ve s\u00fcrekli toplayan bir kurulu\u015f olarak, s\u00f6z konusu verilerin zaman\u0131nda, yeterli ve detayl\u0131 olarak analizlerinin yap\u0131lmas\u0131n\u0131 ve payla\u015f\u0131lmas\u0131n\u0131 da sa\u011flamal\u0131d\u0131r. Bunu kendi imkanlar\u0131 veya g\u00f6revlendirdi\u011fi \/ i\u015fbirli\u011fi yapt\u0131\u011f\u0131 bilim insanlar\u0131yla ger\u00e7ekle\u015ftirebilir ya da \u00fcniversiteler ve ara\u015ft\u0131rma kurumlar\u0131 arac\u0131l\u0131\u011f\u0131yla yapt\u0131rabilir. LitCovid\u2019de bulunan \u00e7ok say\u0131da \u00e7al\u0131\u015fma b\u00f6ylesi i\u015fbirlikleri ile yap\u0131lm\u0131\u015f olmakla birlikte ulusal \u00e7apta bir sonuca ula\u015f\u0131lamam\u0131\u015f olmas\u0131 \u00fcz\u00fcc\u00fcd\u00fcr. Ulusal \u00e7apta, tekrar edilebilir, g\u00fcncel literat\u00fcr ile niteliksel olarak kar\u015f\u0131la\u015ft\u0131r\u0131labilir, bilime katk\u0131n\u0131n yan\u0131 s\u0131ra yenilik getirecek \u00e7al\u0131\u015fmalara ihtiya\u00e7 duyulmaktad\u0131r. Bu ba\u011flamda, \u00f6zellikle yayg\u0131n olarak uygulanan yerli a\u015f\u0131 TurkoVac\u2019\u0131n faz 3 ve etkililik \u00e7al\u0131\u015fma sonu\u00e7lar\u0131n\u0131n analiz edildi\u011fi yay\u0131nlar\u0131n artmas\u0131 \u00e7ok de\u011ferli olacakt\u0131r (2, 14).\u00a0<\/span><\/p>\n Pandemi s\u00fcrecinin ilk a\u015famas\u0131ndan bu yana \u00fclkemizde b\u00fcy\u00fck emek, insan g\u00fcc\u00fc, maliyet ve zaman gerektiren \u00e7al\u0131\u015fmalarla ortaya \u00e7\u0131kan filyasyon verileri maalesef yay\u0131nlara yeterince yans\u0131mam\u0131\u015ft\u0131r. S\u00fcrecin nas\u0131l y\u00f6netildi\u011fi ve ger\u00e7ekle\u015fti\u011fi bilgilerinin yan\u0131 s\u0131ra \u00e7\u0131kt\u0131lar\u0131 da \u00e7ok \u00f6nemlidir. \u00dclkemizde yap\u0131ld\u0131\u011f\u0131 \u015fekliyle ileriye d\u00f6n\u00fck olarak, semptomatik hastal\u0131k ge\u00e7irenlerden bula\u015fma say\u0131s\u0131n\u0131n belirlenmesi \u00f6nemli olmakla birlikte burada elde edilecek etkili \u00fcreme say\u0131s\u0131 (\u201ceffective reproduction number\u201d) olan Re<\/sub> ve zamana ba\u011fl\u0131 etkili \u00fcreme say\u0131s\u0131 olan Rt <\/sub><\/span>de\u011ferleri, herkese de\u011fil sadece temasl\u0131lara PCR testi yap\u0131larak hesapland\u0131\u011f\u0131 takdirde ger\u00e7ek de\u011ferin alt\u0131nda kalacakt\u0131r. Bilindi\u011fi \u00fczere, s\u00fcper bula\u015ft\u0131r\u0131c\u0131lar\u0131n say\u0131s\u0131 az oldu\u011fu i\u00e7in bu t\u00fcr yeni olgu tespitlerinde bula\u015fma say\u0131s\u0131 d\u00fc\u015f\u00fck \u00e7\u0131kaca\u011f\u0131 gibi, kayna\u011f\u0131 bulmak i\u00e7in yap\u0131lan geriye d\u00f6n\u00fck filyasyon verileri hem daha \u201cge\u00e7erli\u201d Re <\/sub>ve Rt <\/sub>de\u011ferleri sa\u011flayacak, hem de bula\u015f ortamlar\u0131n\u0131 ve modelleri (\u201cpatterns\u201d) belirlemeye y\u00f6nelik bulgular ile yerel anlamda koruyuculuk giri\u015fimlerini g\u00fc\u00e7lendirebilecektir.\u00a0<\/span><\/p>\n D\u00fcnyada ilk kez g\u00f6zlenen bir etken olarak SARS-CoV-2\u2019nin ilk tan\u0131mland\u0131\u011f\u0131 g\u00fcnden sonra farkl\u0131 topluluklarda virusun temel bula\u015f\u0131c\u0131l\u0131k ve \u00fcreme katsay\u0131s\u0131 olan Ro<\/sub> de\u011feri kapsam\u0131nda \u00e7ok say\u0131da \u00e7al\u0131\u015fma yap\u0131lm\u0131\u015f, ileriye y\u00f6nelik tahminler i\u00e7in modellemelerde kullan\u0131lm\u0131\u015ft\u0131r. Virusun ortaya \u00e7\u0131kan yeni varyantlar\u0131, toplumsal korunma \u00f6nlemlerine uyumun azalmas\u0131, kitlesel a\u015f\u0131lama gibi de\u011fi\u015fen ko\u015fullar i\u00e7in virusun \u00fcreme say\u0131s\u0131n\u0131n di\u011fer bir deyi\u015fle infekte bireyin ka\u00e7 ki\u015fiyi infekte edece\u011finin ve s\u00fcrece \u00f6zel Re<\/sub> ve Rt <\/sub>de\u011ferlerinin hesaplanmas\u0131n\u0131n \u00f6nemi artm\u0131\u015ft\u0131r. Bula\u015fma yayg\u0131nl\u0131\u011f\u0131, bula\u015fma yollar\u0131, \u00e7evresel etkiler ve koruyucu \u00f6nlemlerin rol\u00fc \u00fczerinde k\u00fc\u00e7\u00fck \u00f6l\u00e7ekli \u00e7al\u0131\u015fmalar yap\u0131lm\u0131\u015f olmakla birlikte toplumun genelinde salg\u0131n\u0131n takibi, varyantlar\u0131n salg\u0131n y\u00fck\u00fcne yans\u0131malar\u0131 ve\/veya yerel varyantlar\u0131n say\u0131 ve boyutuna y\u00f6nelik epidemiyolojik veriler \u00e7o\u011fu geli\u015fmekte olan toplumda halen kar\u015f\u0131lanamam\u0131\u015f bir gereksinimdir (14).<\/p>\n Geli\u015fmekte olan pek \u00e7ok \u00fclkede, kullan\u0131lan tan\u0131 y\u00f6ntemlerinin ge\u00e7erlilik ve g\u00fcvenilirli\u011fine dair \u00e7al\u0131\u015fmalar yap\u0131lm\u0131\u015f olmakla birlikte ulusal olgu say\u0131lar\u0131n\u0131n tespitini sa\u011flayacak \u00e7al\u0131\u015fmalar yap\u0131l(a)mam\u0131\u015ft\u0131r. Yalanc\u0131 pozitiflik ve negatiflik oranlar\u0131yla kullan\u0131lan test \u00f6zelinde ve infeksiyonun evresine g\u00f6re bir \u00fclkede o testin ka\u00e7 adet kullan\u0131ld\u0131\u011f\u0131ndan yola \u00e7\u0131karak olgu say\u0131lar\u0131nda baz\u0131 d\u00fczeltmeler yap\u0131labilir.<\/p>\n K<\/span>\u00fcresel boyutta, COVID-19 nedenli \u00f6l\u00fcmlerin tam olarak tespit edilemedi\u011fi genel kabul g\u00f6ren bir durumdur. \u00d6te yandan, ge\u00e7 tan\u0131 koyulan, erken d\u00f6nemde tedavi edilemeyen hastal\u0131klar, COVID-19 nedeni ile s\u0131n\u0131rlanan poliklinik ve yatak say\u0131lar\u0131n\u0131n yan\u0131 s\u0131ra yasaklar, toplu ta\u015f\u0131ma kullan\u0131m\u0131nda k\u0131s\u0131tlamalar, bireysel \u201ckayg\u0131\/korku\/\u00e7ekinme\u201d kaynakl\u0131 sa\u011fl\u0131k eri\u015fim sorunlar\u0131ndan kaynaklanan morbidite ve mortaliteye y\u00f6nelik \u00e7al\u0131\u015fmalar ile uzam\u0131\u015f COVID-19 \u00e7al\u0131\u015fmalar\u0131 k\u00fc\u00e7\u00fck \u00e7apl\u0131, se\u00e7ime ba\u011fl\u0131 genellenebilirli\u011fi d\u00fc\u015f\u00fck ve ulusal yans\u0131mas\u0131 yap\u0131lamayacak niteliktedir. Bu \u00e7al\u0131\u015fmalar\u0131n ulusal \u00e7apta yap\u0131labilmesi i\u00e7in niyet, motivasyon ve finans deste\u011fi de\u011ferli olacakt\u0131r. Pandemi d\u00f6neminde COVID-19 kaynakl\u0131 \u00f6l\u00fcmler kadar, tan\u0131 ve tedavideki gecikmelerden kaynakl\u0131 COVID-19 d\u0131\u015f\u0131 nedenlerin sebep oldu\u011fu \u00f6l\u00fcmlerin de artaca\u011f\u0131\/artt\u0131\u011f\u0131 a\u00e7\u0131kt\u0131r. Toplumsal boyutta ge\u00e7erli sonu\u00e7lar elde edebilmek i\u00e7in gerek hastanede gerekse hastaneye ula\u015famadan ger\u00e7ekle\u015fen \u00f6l\u00fcmlere ait kay\u0131tlar\u0131n\u00a0 <\/span>standartlara uygun ve detayl\u0131 bir \u015fekilde tutulmas\u0131 \u00f6nemlidir. COVID-19 pandemisi s\u00fcrecinde genel kabul g\u00f6ren tedaviler ve\/veya bunlar d\u0131\u015f\u0131ndaki ila\u00e7lar\u0131n, hasta tedavisi\/korunmada etkili oldu\u011fu gerek\u00e7esi ile farkl\u0131 topluluklarda kullan\u0131labildi\u011fini biliyoruz. Bunlar\u0131n nedenleri incelendi\u011finde; yap\u0131lan klinik \u00e7al\u0131\u015fmalar\u0131n bir k\u0131sm\u0131nda se\u00e7ilen hasta gruplar\u0131n\u0131n kar\u015f\u0131la\u015ft\u0131rmalar i\u00e7in ba\u015flang\u0131\u00e7 a\u015famas\u0131nda uygun olmad\u0131\u011f\u0131 (ya\u015f, cinsiyet, komorbidite, hastal\u0131k \u015fiddeti, e\u015flik eden ila\u00e7 kullan\u0131m\u0131 vb. nedenlerle), herhangi bir hastal\u0131\u011f\u0131 olanlar\u0131n olmayanlar ile COVID-19 hastane yat\u0131\u015f\u0131 ve\/veya fatalitesi a\u00e7\u0131s\u0131ndan kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131nda altta yatan hastal\u0131\u011f\u0131n do\u011frudan veya dolayl\u0131 olarak \u00f6l\u00fcme etkilerinin yeterince incelenmedi\u011fi, \u00f6l\u00e7\u00fcm y\u00f6ntemlerinin kar\u015f\u0131la\u015ft\u0131rma gruplar\u0131nda benzer olmad\u0131\u011f\u0131, kullan\u0131lan baz\u0131 ila\u00e7lar\u0131n ilac\u0131n hastan\u0131n \u00f6zel durumundan kaynaklanan gerek\u00e7elerle ba\u015flanmas\u0131 nedeniyle\u00a0 <\/span>(\u201cconfounding by indication\u201d) sonuca etkileri a\u00e7\u0131s\u0131ndan kar\u015f\u0131la\u015ft\u0131r\u0131labilir olmad\u0131\u011f\u0131, kimi zaman \u00f6rneklem say\u0131s\u0131n\u0131n yeterli olmamas\u0131na ba\u011fl\u0131 olarak ili\u015fkinin tip 2 hata nedeniyle g\u00f6sterilememi\u015f olmas\u0131n\u0131n ekarte edilememesi, e\u015fle\u015ftirilmi\u015f bir \u00e7al\u0131\u015fma grubu se\u00e7ilmesine ra\u011fmen analizlerde bu \u00f6zelli\u011fin dikkate al\u0131nmam\u0131\u015f olmas\u0131 s\u0131k rastlanan y\u00f6ntemsel sorunlar olarak g\u00f6zlenmi\u015ftir.\u00a0 <\/span>\u00d6zellikle hastal\u0131k s\u00fcreci ve tedavi sonras\u0131 izlem s\u00fcrelerinin benzer olmamas\u0131 ve hastalar\u0131n hastane yat\u0131\u015f\u0131 sonras\u0131 durumlar\u0131n\u0131n takip edilememesi gibi nedenlerle y\u00fczde\/k\u00fcm\u00fclatif insidans \u00fczerinden hesaplamalar yap\u0131lmas\u0131 uygun olmayacakt\u0131r. \u00dcst\u00fcnl\u00fck \u00e7al\u0131\u015fmas\u0131 (\u201csuperiority trial\u201d) \u015feklinde planlanm\u0131\u015f bir \u00e7al\u0131\u015fmada, pre-set p<\/i> de\u011ferleri \u00fczerinden ger\u00e7ekle\u015ftirilen analizlerin en az onun kadar etkili<\/i> (\u201cnon-inferior\u201d) \u015feklinde yorumlanmas\u0131 uygun olmayacakt\u0131r. \u00dcst\u00fcnl\u00fck \u00e7al\u0131\u015fmalar\u0131ndaki \u00f6rneklem se\u00e7im ve say\u0131s\u0131, p<\/i> de\u011ferlerinin yorumlanmas\u0131 \u201cnon-inferiority trial\u201d<\/i> i\u00e7in farkl\u0131 olup \u201cnon-inferiority margin\u201d<\/i> ismi verilen kabul edilebilen alt e\u015fitlik\/denklik s\u0131n\u0131r\u0131n\u0131n \u00e7al\u0131\u015fmada analiz \u00f6ncesinde belirlenmi\u015f olmas\u0131 gerekmektedir. \u00d6nceki deneyim, hastal\u0131klar\u0131n benzer \u00f6zellikleri, ilac\u0131n daha \u00f6nce bir hasta grubunda COVID-19 i\u00e7in sorunsuz kullan\u0131lm\u0131\u015f olmas\u0131 sebebiyle \u00e7ok say\u0131da ila\u00e7, etkisinin denenmesi i\u00e7in hasta \u00f6zelinde bak\u0131m veren doktor taraf\u0131ndan kullan\u0131labilir. \u00d6te yandan, endikasyon d\u0131\u015f\u0131 kullan\u0131lacak ila\u00e7lar\u0131n mutlaka hastalardan ayd\u0131nlat\u0131lm\u0131\u015f onam al\u0131narak deneysel \u00e7al\u0131\u015fma stat\u00fcs\u00fcnde kullan\u0131lmas\u0131 gereklidir. Bu durum \u00fclkemizde de yasal olarak zorunludur.\u00a0<\/span><\/p>\n Denenmemi\u015f ila\u00e7lar\u0131n g\u00f6zlemsel ara\u015ft\u0131rmalarda kar\u0131\u015ft\u0131r\u0131c\u0131 de\u011fi\u015fkenler dikkate al\u0131nmadan \u201cetkili bulunmas\u0131<\/i>\u201d durumunda, \u00e7al\u0131\u015fman\u0131n yay\u0131ma haz\u0131rlanan dok\u00fcman\u0131nda \u201cila\u00e7 COVID-19 i\u00e7in etkili bulunmu\u015ftur; geni\u015f, randomize kontroll\u00fc \u00e7al\u0131\u015fmalar ile teyidi uygun olacakt\u0131r<\/i>\u201d c\u00fcmlesi y\u00f6ntemsel a\u00e7\u0131dan uygun de\u011fildir. G\u00f6zlemsel \u00e7al\u0131\u015fmalar\u0131n; sadece ili\u015fki (asosyasyon)<\/i> a\u00e7\u0131s\u0131ndan bilgi verebilece\u011fi, yanl\u0131l\u0131k (\u201cbias\u201d) ve kar\u0131\u015ft\u0131r\u0131c\u0131 de\u011fi\u015fkenler \u00e7ok iyi kontrol edildi\u011finde ve tekrarlayan \u00e7al\u0131\u015fmalarda benzer sonu\u00e7lar \u00e7\u0131kmas\u0131 durumunda bu ili\u015fkinin g\u00fc\u00e7l\u00fc olarak kabul edilebilece\u011fi, klinik \u00e7al\u0131\u015fman\u0131n bu bulgulara ba\u011fl\u0131 olarak planlanarak, nedensellik a\u00e7\u0131s\u0131ndan ileri incelemeye ge\u00e7ilmesi gerekti\u011fi unutulmamal\u0131d\u0131r.\u00a0<\/span><\/p>\n Kan\u0131ta dayal\u0131 t\u0131p uygulamalar\u0131nda farkl\u0131 sistem ve kurulu\u015flar\u0131n \u00f6neri kriterleri olsa da bunlar az \u00e7ok benzerlik g\u00f6stermektedir. \u00d6rne\u011fin, Amerikan Aile Hekimleri Akademisi (\u201cAmerican Academy of Family Physicians\u201d) SORT (\u201cStrength of Recommendation Taxonomy\u201d) s\u0131n\u0131flamas\u0131n\u0131 kullanmaktad\u0131r. \u00c7al\u0131\u015fman\u0131n istenen etken-sonu\u00e7 ili\u015fkisini de\u011ferlendirerek, belirli bir ilac\u0131n kullan\u0131lmas\u0131nda en y\u00fcksek \u00f6neri derecesi olan \u201cD\u00fczey 1\u201d i\u00e7in t\u00fcm ilgili randomize kontroll\u00fc \u00e7al\u0131\u015fmalardan yap\u0131lm\u0131\u015f sistematik derlemenin sonucu esas al\u0131n\u0131r. Tekil \u00e7al\u0131\u015fmalardan gelen kan\u0131t esas al\u0131nd\u0131\u011f\u0131nda, \u00e7al\u0131\u015fma iyi planlanm\u0131\u015f bir randomize kontroll\u00fc \u00e7al\u0131\u015fma olsa dahi \u00f6neri \u201cD\u00fczey 7\u201d olarak kabul edilmektedir. Randomize olmayan ve g\u00f6zlemsel (tekil) \u00e7al\u0131\u015fmalardan elde edilen sonu\u00e7lar i\u00e7in \u201cD\u00fczey 8\u201d olarak kabul edilen bir \u00f6neri s\u00f6z konusu olup bunun olmad\u0131\u011f\u0131 durumlarda \u201cD\u00fczey 9\u201d olarak uzman paneli raporlar\u0131 ve ilgili kurulu\u015flar\u0131n bilimsel g\u00f6r\u00fc\u015fleri esas al\u0131n\u0131r (15). Pandemi ko\u015fullar\u0131nda; y\u00fcksek morbidite, mortalite, hastanelerin y\u00fcksek doluluk oranlar\u0131 ve toplumsal panik riski nedeniyle, d\u00fc\u015f\u00fck kan\u0131t d\u00fczeyine dayal\u0131 \u00f6neriler kabul edilebilmi\u015f olmakla birlikte daha y\u00fcksek d\u00fczeyde bir kan\u0131t kalitesi olan \u00e7al\u0131\u015fma bulgular\u0131yla ters d\u00fc\u015fen bir tekil \u00e7al\u0131\u015fmada, \u00f6zellikle g\u00f6zlemsel \u00f6zellikte ise, \u00f6ncelikle elde edilen bulgular\u0131n epidemiyolojik veri kalitesi, \u00f6l\u00e7me ve analiz y\u00f6ntemleri dikkatle g\u00f6zden ge\u00e7irilmelidir. Klinikte hekim g\u00f6zetiminde ve alternatifi olmayan ko\u015fullarda, hasta\/yak\u0131n\u0131 bilgisi ve onam\u0131 ile ila\u00e7 kullan\u0131lmas\u0131 durumunun toplum genelinde ila\u00e7 kullan\u0131lmas\u0131na getirilen \u00f6nerilerin bilimsel kan\u0131t d\u00fczeyi, etik ve yasal yapt\u0131r\u0131mlar\u0131 \u015f\u00fcphesiz farkl\u0131 olmal\u0131d\u0131r. Epidemiyolojik veri kalitesi a\u00e7\u0131s\u0131ndan benzer nitelikteki iki \u00e7al\u0131\u015fmadan farkl\u0131 bulgular elde ediliyorsa \u00e7al\u0131\u015fmalar\u0131n \u00f6rneklemlerinin; genetik, \u00e7evresel ve davran\u0131\u015fsal farkl\u0131l\u0131klar\u0131n\u0131n irdelenmesi ve farkl\u0131l\u0131k nedenlerinin a\u00e7\u0131klanmas\u0131 gerekmektedir. Ara\u015ft\u0131rmalarda taraf tutman\u0131n istemli olmad\u0131\u011f\u0131 esas al\u0131nmakla birlikte ara\u015ft\u0131rma y\u00f6ntemlerinde yap\u0131lan hata ve eksikliklerin\u00a0 <\/span>\u201cfark\u0131na varmadan\u201d yan tutmaya neden olabilece\u011fi unutulmamal\u0131d\u0131r; bunun sonras\u0131ndaki uygulamalarda ortaya \u00e7\u0131kacak istenmeyen insan g\u00fcc\u00fc, finans ve sa\u011fl\u0131k maliyetinden ara\u015ft\u0131rmac\u0131lar\u0131n sorumlu tutulaca\u011f\u0131 dikkate al\u0131nmal\u0131d\u0131r (4).\u00a0<\/span><\/p>\n Bilimsel \u00e7al\u0131\u015fmalar\u0131n her zaman bulu\u015f hedefli olarak yap\u0131lmad\u0131\u011f\u0131 kabul edilmekle birlikte bilimsel ara\u015ft\u0131rma y\u00f6ntemi standartlar\u0131na uygun olarak, g\u00fcncel sorulara yan\u0131t vermeye y\u00f6nelik, objektif, tekrar edilebilir ve \u015feffaf olmas\u0131 \u00f6nemlidir. Bu yakla\u015f\u0131mla, yeter say\u0131da ki\u015fi ile multidisipliner \u00e7al\u0131\u015fmalar yap\u0131lmas\u0131 hem ba\u015far\u0131ya giden yolda h\u0131zl\u0131 yol almay\u0131 sa\u011flayacak hem de ekip \u00fcyeleri aras\u0131nda \u201cortak bir dil yaratma\u201d becerisiyle birlikte ileride yap\u0131lacak t\u0131p ve sa\u011fl\u0131k bilimleri alanlar\u0131nda ger\u00e7ekle\u015ftirilen ara\u015ft\u0131rmalarda ge\u00e7erli ve genellenebilir sonu\u00e7lar elde edilmesini sa\u011flayacakt\u0131r.<\/p>\n","protected":false},"excerpt":{"rendered":" G\u0130R\u0130\u015e SARS-CoV-2 virusu kolay ve h\u0131zla yay\u0131lma g\u00fcc\u00fc ile bir anda k\u00fcresel bir halk sa\u011fl\u0131\u011f\u0131 sorununa d\u00f6n\u00fc\u015fm\u00fc\u015f, sosyal ve ekonomik ya\u015fam\u0131 da olumsuz etkilemi\u015ftir. \u00dc\u00e7\u00fcnc\u00fc y\u0131l\u0131n\u0131 tamamlamaya yakla\u015ft\u0131\u011f\u0131m\u0131z COVID-19 pandemisi halen en \u00f6nemli morbidite ve mortalite nedenlerinin ba\u015f\u0131nda gelmektedir. Di\u011fer yanda bilimsel ara\u015ft\u0131rma ve yay\u0131n say\u0131s\u0131ndaki art\u0131\u015f pandeminin sa\u011fl\u0131k alan\u0131nda yaratt\u0131\u011f\u0131 \u00f6nemli ve olumlu bir […]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5127],"tags":[5174,5569,5570],"class_list":["post-25978","post","type-post","status-publish","format-standard","hentry","category-derleme","tag-covid-19","tag-yayinlar","tag-yontemsel-sorunlar"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/25978","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/comments?post=25978"}],"version-history":[{"count":4,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/25978\/revisions"}],"predecessor-version":[{"id":26294,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/25978\/revisions\/26294"}],"wp:attachment":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/media?parent=25978"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/categories?post=25978"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/tags?post=25978"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\u00c7al\u0131\u015fma Tasar\u0131mlar\u0131<\/h3>\n
\u00c7al\u0131\u015fma Tasar\u0131m\u0131n\u0131n Ko\u015fullar\u0131 ve \u00c7\u0131kt\u0131lar<\/h3>\n
\u0130\u00e7 ve D\u0131\u015f Ge\u00e7erlilik<\/h3>\n
Se\u00e7im \u00d6zellikleri<\/h3>\n
Kar\u0131\u015ft\u0131c\u0131 De\u011fi\u015fken Kontrol\u00fc ve Etki De\u011fi\u015fimi<\/h3>\n
\n<\/i><\/span>Rapel Uygulamalar\u0131nda Etki De\u011ferlendirme<\/h3>\n
\n<\/b><\/span>A\u015f\u0131laman\u0131n Etkilerinin Toplum Boyutunda \u0130ncelenmesi<\/h3>\nFilyasyon \u0130ncelemelerinin Getirisi<\/h3>\n
Tan\u0131 Y\u00f6ntemleri<\/h3>\n
\u00d6l\u00fcmlerin De\u011ferlendirilmesi<\/h3>\n
\n<\/b><\/p>\nTedavi De\u011ferlendirmeleri<\/span><\/h3>\n
SONU\u00c7<\/h2>\n