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Primena Statistike U Kliničkim Istraţivanjima Sa Osvrtom Na Korišćenje Računarskih Programa

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Primena Statistike U Kliničkim Istraţivanjima Sa Osvrtom Na Korišćenje Računarskih Programa UNIVERZITET U BEOGRADU MATEMATIČKI FAKULTET Dušica V. Gavrilović Primena statistike u kliničkim istraţivanjima sa osvrtom na korišćenje računarskih programa - Master rad - Mentor: prof. dr Vesna Jevremović Beograd, 2013. godine Zahvalnica Ovaj rad bi bilo veoma teško napisati da nisam imala stručnu podršku, kvalitetne sugestije i reviziju, pomoć prijatelja, razumevanje kolega i beskrajnu podršku porodice. To su razlozi zbog kojih želim da se zahvalim: . Mom mentoru, prof. dr Vesni Jevremović sa Matematičkog fakulteta Univerziteta u Beogradu, koja je bila ne samo idejni tvorac ovog rada već i dugogodišnja podrška u njegovoj realizaciji. Njena neverovatna upornost, razne sugestije, neiscrpni optimizam, profesionalizam i razumevanje, predstavljali su moj stalni izvor snage na ovom master-putu. Članu komisije, doc. dr Zorici Stanimirović sa Matematičkog fakulteta Univerziteta u Beogradu, na izuzetnoj ekspeditivnosti, stručnoj recenziji, razumevanju, strpljenju i brojnim korisnim savetima. Članu komisije, mr Marku Obradoviću sa Matematičkog fakulteta Univerziteta u Beogradu, na stručnoj i prijateljskoj podršci kao i spremnosti na saradnju. Dipl. mat. Radojki Pavlović, šefu studentske službe Matematičkog fakulteta Univerziteta u Beogradu, na upornosti, snalažljivosti i kreativnosti u pronalaženju raznih ideja, predloga i rešenja na putu realizacije ovog master rada. Dugogodišnje prijateljstvo sa njom oduvek beskrajno cenim i oduvek mi mnogo znači. Dipl. mat. Zorani Bizetić, načelniku Data Centra Instituta za onkologiju i radiologiju Srbije, na upornosti, idejama, detaljnoj reviziji, korisnim sugestijama i svakojakoj podršci. Čak i kada je neverovatno ili dosadno ili pametno uporna, mnogo je i dugo volim – skoro ceo moj život. Mast. biol. Jelici Novaković na strpljenju, reviziji, bezbrojnim korekcijama i tehničkoj podršci svake vrste. Hvala na osmehu, budnom oku u sitne sate, izvrsnoj hrani koja me je vraćala u život, nes-kafi sa penom i transfuziji energije kada sam bila na rezervi. Hvala joj što je tu i što je moja. Dipl. inž. građ. Draganu Gavriloviću, mom suprugu Gaši, na pomoći, sugestijama, strpljenju, smehu, podršci. On je uvek bio, jeste i biće moj životni oslonac i inspiracija, moje vrelo smeha i šale, moj najbolji prijatelj, moja snaga i moje drugo ja. Hvala mu što postoji i što je baš – moj. Dipl. mat. Milici Novaković, profesoru matematike u šidskoj gimnaziji “Sava Šumanović”, na stručnoj reviziji, strpljenju, beskrajnoj energiji i izdržljivosti. Njena jednostavnost, požrtvovanost, brižnost i toplina ali i dar za božanstvene kiflice i slatkiše, predstavljaju ono zbog čega se oseća srećno baš svako ko je poznaje. Hvala joj što je jednom davno postala moja. Mojim sinovima Nikiti i Borisu Gavrilović na upornom i dugotrajnom traženju grešaka u tekstu, na strpljenju i miru koji su imali dok sam pisala ovaj rad. Oni su moj život, sunce, srce i bogatstvo i taman kada pomislim da ih ne mogu voleti više, oni mi pruže novi razlog za još. Dragi dečaci, zahvaljujući vama, pojam “beskrajno” se neprestano uvećava i raste. Ivi Kežić, magistru biostatistike, na rečima i porukama punim podrške, energije i snage koje mi je slala iz daleka. Svojim ličnim primerom, bogatstvom i lepotom sopstvene duše, učinila je i mene jačom, boljom i kompletnijom. Hvala joj što je vrhunski biostatističar, što je humanista i borac, što postoji i što je moj najbolji ženski prijatelj koji me stalno menja i čini boljom. Ireni Ćosić, Dušku Stojanovskom i Dušanki Rapajić, mojim kolegama iz Data Centra Instituta za onkologiju i radiologiju Srbije koji su me u pisanju ovog rada podržavali osmehom, strpljenjem i razumevanjem, čak i kada je za sve to bilo prilično teško pronaći pristojan razlog. I na kraju Milici Petrović – Seki, mojoj mami, koja bi bila srećna i ponosna da je mogla da dočeka bar moje zvanje dipl. mat. Danas, uz ovu moju porodicu i ovo zvanje, znam da bi bila presrećna i preponosna. Ta moja tako malena a tako velika mama, imala je snage da svojom čistotom i ljubavlju izveze srećan početak jednog sićušnog ali časnog i srećnog mesta pod suncem - samo za mene. Večna joj slava i hvala za to, za ljubav i pažnju, za to što je bila baš - moja mama. Zahvaljujući ovim dragim ljudima, njihovoj podršci, pažnji, ljubavi i strpljenju, jedna ideja i jedna želja sada su postali stvarnost. Hvala vam. Dušica Gavrilović Apstrakt BIOSTATISTIKA I KLINIČKA ISTRAŢIVANJA – ČESTE GREŠKE Od ciljeva istraživanja, obima uzorka i kvaliteta podataka zavisi izbor statističkih metoda i njihova primena, što se kroz rezultate direktno odražava na ukupan kvalitet istraživanja. Zbog grešaka u bilo kojoj od ovih faza, veliki broj radova nikada ne bude objavljen. Cilj ovoga rada je bio da se ukaže na neke od uobičajenih grešaka, da bi se one izbegle ili minimizirale. Najčešće i najteže greške u kliničkim istraživanjima se prave u fazi njihovog planiranja (pogrešan dizajn studije; neprecizni/neadekvatni ciljevi; problem jedinke istraživanja; problem uzorka; problem predviđene statističke metodologije). U fazi prikupljanja podataka, najčešće greške su vezane za neprecizne merne skale, neusaglašenost jedinica mere i veliki broj nedostajućih podataka. Zbog neiskustva statističara, ali i zbog dostupnosti i jednostavnosti statističkih paketa koji daju slobodu nestatističarima za samostalnu statističku analizu bez dovoljnog predznanja, u fazi statističke obrade podataka najčešće greške nastaju usled pogrešnog izbora statističke metodologije, njenog nerazumevanja ili zbog neproveravanja ispunjenosti uslova za njenu primenu (mešanje zavisnih/nezavisnih podataka i/ili parametarskih/neparametarskih klasa testova). U fazi tumačenja rezultata statističke analize, greške nastaju najčešće usled nedovoljnog poznavanja statističke metodologije ili neadekvatne statističke analize (nehomogenost komparativnih grupa; pristrasnost; zbunjujući faktor; preterana stratifikacija i inflacija greške I vrste). Ovim nisu iscrpljene sve greške u kliničkim istraživanjima. Neke od njih nastaju usled nedovoljnog razumevanja suštine pojmova u statistici (p-value; 95% CI; Relative Ratio; ODDS Ratio; Hazard Ratio), dela njene metodologije (Survival analyses: DFI vs. DFS vs. TTP; censored data) ili karakteristika i ciljeva različitih tipova kliničkih studija (end-points-a). Pored edukacije statističara za poslove biostatističara i popularizovanja uloge biostatističara u kliničkim istraživanjima počev od faze njegovog planiranja, treba podizati i nivo znanja, svesti i odgovornosti istraživača, a posebno nestatističara koji samostalno obavljaju statistički analizu. Ovakav stav predstavlja dobru osnovu za izbegavanje ili minimiziranje grešaka a samimi tim i podizanje ukupnog kvaliteta istraživanja. Ključne reči: statistika i medicinska istraživanja; česte greške u statističkoj analizi Abstract BIOSTATISTICS & CLINICAL RESEARCH - COMMON MISCONCEPTIONS The quality of scientific research largely depends on formulating feasible study objectives, sample size, quality of collected data and the choice of the analysis methods. Errors in any of those largely compromise the quality of the research in such a way that many of the scientific papers never get published. The objective of this paper is to highlight some of the most common errors and misconceptions so that they can be avoided or their impact can be minimized. The most common mistakes in clinical research are made in the planning stage (unsuitable design, objectives of the research not carefully and clearly stated, research population choice, non-optimal sample size, non-adequate choice of statistical methods). During the data collection errors such as using measurement scales that are not precise enough, collecting data from various non-reliable sources and not preventing the loss of information which leads to missing data can have hudge consequences on the quality of the research. Due to wide availability of user-friendly statstical software, non-statisticians, but also non-experienced statisticians often use non-suitable statistical methods to analyze the data. This usually arises from either non-understanding the statistical science behind the methods and using them without checking the conditions under which they can be used (confusing paired and non-paired data parametric and non parametric tests). Poor understanding of statistical methods along with neglecting important statistical aspects (homogeneity of treatment groups, different kind of biases, confounding factors, non-correcting for multiplicity testing) lead into erroneous interpreatation of the researchy findings. These are not the only pitfalls into which reasearches can fall while performing the statistical analysis. Some of them can arise due to misunderstanding of basic staistical concepts such as p-value, 95%CI, risk ratio, odds ratio, hazard ratio, but also due to non-careful definitions of primary research variables (DFI, DFS, TTP etc.) The importance of the role of a biostatistician in all the phases of clinical research, specially in the planning phase, must be clear to the research scientists. Research scientist should be aware of all the consequences if research is not carefully planned or executed in accordance with the statistical aspects of providing reliable results. Professional statisticians should be educated also in the field of biostatistics, while non-statisticians working on the statistical analysis need guidance from biostatisticians with knowledge or experience. Key words: statistics and medical research; common errors in statistical analysis Sadrţaj: 1 UVOD ...........................................................................................................................
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