Ar Soltanian, M Mirfakhraei , H Mahjub, A Moghimbeigi, Sh Akhondzadeh,
Volume 10, Issue 2 (Vol 10, No 2 2014)
Abstract
Background & Objectives: The standard methods for the comparison of two drugs in a randomized controlled clinical trial in the presence of non-compliance are intention-to-treat or per-protocol approaches. Both approaches have problems with estimation of drug effects, and researchers are not still certain to adopt which one. In this study, the bias of intention-to-treat and per-protocol approaches was calculated using Monte-Carlo simulation. We tried to choose the best approach (based on the AIC index) for comparing Risperidone plus Celecoxib and Risperidone plus Placebo.
Methods: This secondary study was conducted to compare the effect of Risperidone plus Celecoxib and Risperidone plus Placebo among 60 schizophrenic patients. To choose between the intention-to-treat and per-protocol approaches, Monte-Carlo simulation with Ackaike (AIC) and Baysian (BIC) indices was used.
Results: The results of Monte-Carlo simulation showed that when the sample size was small (n=30 or n=60) under fixed conditions of non-compliance equal to 5% and 10%, intention-to-treat had a better goodness of fit than per-protocol based on AIC and BIC. However, increasing the sample size in active and placebo groups (e.g., n=100) showed that per-protocol had a better goodness of fit than intention-to-treat.
Conclusion: When the sample size is large, the per-protocol approach may have a better goodness of fit than intention-to-treat to address the effects of non-compliance in randomized clinical trials.
A Naghi Pour, A Moghimbeigi, N Shirmohamadi, A Soltanian, S Khazaei, Sh Nick Ceiar,
Volume 17, Issue 4 (Vol.17, No.4, Winter 2022 2022)
Abstract
Background and Objectives: Breast cancer has the highest incidence in the Iranian women.
Methods: A cross-sectional study was conducted. All female with breast cancer during 2008-2015 were enrolled. Breast cancer registration is based on the pathology method in Iran. The information about female with breast cancer was collected from their files in the cancer registry department of Hamadan Health Center. The samples were divided into four groups according to age (<50 and> 50) and location (city, village). GeoBUGS was used to generate a map of high-risk areas in Hamedan Province based on the adjusted relative risk estimate (RR*) in OpenBUGS v 3.2.3 software.
Results: This study included 1316 females with breast cancer. The mean age of the patients was 50.38±12.98 years. The results of the study showed that high-risk areas of breast cancer for were Assadabad urban females aged over 50 years (RR*(i)=1.32, CI= 0.99,1.79) and Tuyserkan (RR*(i)=1.09, CI= 1.08,1.38) and Razan (RR*(i)=1.09, CI= 0.85,1.40) for females below 50 years. In addition, Razan for rural females over 50 years old (RR*(i)=1.18, CI=0.82,1.73) and Malayer for females below 50 years old (RR*(i)=1.08, CI= 0.81,1.45) were high risk areas for breast cancer in Hamadan Province.
Conclusion: The distribution of breast cancer is different at different ages and in the cities of Hamadan Province. Asadabad, Tuyserkan, Razan and Malayer were high risk areas for breast cancer in Hamadan Province.
