Volume 10, Issue 2 (Vol 10, No 2 2014)                   irje 2014, 10(2): 15-23 | Back to browse issues page

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Soltanian A, Mirfakhraei M, Mahjub H, Moghimbeigi A, Akhondzadeh S. Comparison of the Validity of Intention-To-Treat and Per-Protocol Approaches Using Monte-Carlo Simulation: Secondary Analysis of a Clinical Trial in the Treatment of Schizophrenic Patients in the Presence of Non-Compliance. irje. 2014; 10 (2) :15-23
URL: http://irje.tums.ac.ir/article-1-5235-en.html
1- , a_sultanian@yahoo.com
Abstract:   (10255 Views)

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.

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Type of Study: Research | Subject: General
Received: 2014/11/22 | Accepted: 2014/11/22 | Published: 2014/11/22

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