Randomize Kontrollü Çalışma Yapmak
Özet
Klinik araştırmalarda, katılımcıların tedavi veya kontrol kollarına rastgele atanmasıyla karakterize Randomize Kontrollü Çalışma (RKÇ) tasarımı, bir müdahalenin etkisini değerlendirmede altın standart olarak kabul edilmektedir. Çalışma protokolü oluştururken üç ana unsur; çalışma yapılacak grup yani katılımcıların özellikleri, uygulanacak müdahaleler ve bu müdahalelerin etkisinin nasıl değerlendirileceğidir. Çalışmanın hipotezine uygun çalışma tasarımı ve çalışma popülasyonu belirlemek önemlidir. Bir RKÇ protokolü oluşturmadan önce randomizasyon, atama gizliliği, körleme, yanlılık çeşitleri gibi bilinmesi gereken temel kavramlar vardır. Aynı zamanda son durum değerlendirme ölçütlerinin nasıl seçileceği, istatistiksel analizde nelere bakılması gerektiği ve sonuçların nasıl raporlanacağı da çalışma planlama aşamasında belirlenmelidir. Bu kitap bölümü, bu unsurlara ilişkin genel bakış sağlamak ve klinik araştırmaların yürütülmesi ve yorumlanmasına ilişkin önemli yönleri vurgulamak amacıyla yazılmıştır.
In clinical research, the Randomized Controlled Trial (RCT) design, characterized by the random assignment of participants to treatment or control arms, is considered the gold standard for evaluating the effect of an intervention. When developing a study protocol, three main elements should be defined: the study group, that is, the characteristics of the participants; the interventions to be applied; and how the effects of these interventions will be evaluated. It is important to determine a study design and study population that are appropriate for the study hypothesis. Before developing an RCT protocol, there are fundamental concepts that need to be understood, such as randomization, allocation concealment, blinding, and types of bias. In addition, the selection of outcome measures, considerations for statistical analysis, and how the results will be reported should also be determined during the study planning phase. This book chapter was written to provide an overview of these elements and to highlight important aspects related to the conduct and interpretation of clinical research.
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