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  • ISSN: 2378-9328
    Volume 2, Issue 2
    Short Communication
    Li Cheng1* and Xiaohong Li2
    Abstract: Non-compliance or non-adherence is one of potential threats to the internal validity of randomized controlled trials. The purpose of this study is to illustrate strategies to improve study validity threatened by non-adherence, which may shed light on methodology design and statistical analysis.
    Marlon de Freitas Fonseca1*, Felipe Ventura Sessa1, Lilian de Carvalho Aragao1, Jose Anacleto Dutra de Resende Junior2 and Claudio Peixoto Crispi3
    Abstract: Deep infiltrating endometriosis (DIE) is a particular form of endometriosis that extends more than 5 mm under the peritoneal surface. The radical surgical exeresis of the lesions may be necessary to improve symptoms, the mainstay of its treatment.In this sectional pre-planned observational study (Canadian Task Force Classification II-2), we evaluatedthe association between the two main endometriosis-associated painful symptoms in 77 women, in which the diagnosis of deep infiltrating endometriosis (DIE) was based on medical history, physical examination and magnetic resonance imaging (MRI).The statistical approach included non-parametric bivariate correlation and hierarchical agglomerative clustering method as exploratory multivariate analysis.This study was previously approved by the Research Ethics Committee (CEP IFF-FIOCRUZ: 0035.0.008.000-11).The median values were 5.0 (CI95%: 3.0 - 6.5; IQR: 1.75 − 8.00) and 8.5 (CI95%: 6.4 − 9.1; IQR: 3.15 − 9.93) for dyspareunia and dysmenorrhea intensities, respectively.There was no significant correlation between dyspareunia and dysmenorrhea (P=.86).Regarding the multivariate cluster analysis, women's age presented much more similarity with dysmenorrhea than with dyspareuniaintensity. In fact, the similarity between dyspareunia and dysmenorrhea was very poor. Concerning women affected by deep infiltrating endometriosis, we concluded that dyspareunia and dysmenorrhea occur in an independent way, which denotes a quite heterogeneous condition.
    Shihua Wen*, Greg Ball and Jyotirmoy Dey
    Abstract: Monitoring of patient safety is an indispensable part of clinical trial planning and conduct. Proactive safety signal monitoring using blinded data in on-going clinical trials enables pharmaceutical sponsors to monitor patient safety closely while maintaining the study blind. Bayesian methods, by their nature of updating knowledge based on accumulating data and synthesis of prior knowledge, provide an excellent framework for carrying out such monitoring of safety. This short communication summarizes a straightforward Bayesian framework which can be applied to safety monitoring for one or more adverse events of special interest in real clinical trial settings. This framework is general enough to allow adaptation to a number of different Bayesian models appropriate for application to different clinical settings and types of data (such as rare events, exposure-dependent events or continuous laboratory parameters). An instructive case study is presented to demonstrate the utility of the proposed method.
    Mahmoud Hajipour, Shahab Rezaeian, Malihe Abdollahi, Ali Semati, Mohsen Shafiee, Mehdi Sharafi, Maryam Soltani and Mohamad Javad Fatemi
    Abstract:
    Background: There recently are multiple different iron-chelation regimens among thalassemia patients in Iran. The aim of our study was evaluated the efficacy of combined chelation therapy on survival time of the beta-thalassemia major patients.
    Methods: A retrospective cohort study was performed on 667 beta-thalassemia major patients in Shiraz, Iran. Using a predetermined checklist data were collected from their medical records. For analysis, patients were divided into two groups (exposure variable); one drug (single-agent therapy) and two or more drugs (combination therapy). Dependent variable is survival time following combination therapy. We used Kaplan-Meier curves and Cox proportional hazards model to identify the effect of combined therapy against mortality of the patients.
    Results: Both crude (HR=0.30, 95%CI: 0.19, 0.43) and adjusted (HR=0.52, 95% CI: 0.31, 0.86) hazard ratios showed that combination therapy was significantly associated with decreased risk of mortality. The 10-year, 20-year and 40-year survival rates for patients with combination therapy were 99%, 93% and 78%, respectively. However, the 10-year, 20-year and 40-year survival rates for patients receiving single agent therapy were 98%, 74% and 47%, respectively.
    Conclusion: The findings of this study showed that the combination therapy is associated with lower risk of mortality. Future prospective studies are needed in future to examine this association to achieve the maximum accuracy of the results.
    Research Article
    Jamal Ahmadzadeh1, Shahab Rezaeian2*, Abbas Esmahili-Sani3, Bafrin Lava3, Kazhal Mobaraki3, Saide Amini3 and Sepideh Amini3
    Abstract: Dental caries is the most prevalent chronic disease affecting a large portion of children in Iran. The aim of present study was to investigate factors associated with dental caries among children. This cross-sectional study was conducted in Sardasht City, the northwest of Iran, enrolling 448 children aged 6-12 years old based on census method. Clinical examination was conducted and the World Health Organization (WHO) criteria were for caries diagnosis. Odds Ratio (OR) estimates for factors associated with dental caries using STATA software. The prevalence of dental caries was 49.3% and the mean DMFT score was 1.4 [95% CI: 1.2, 1.6]. Odds ratio indicated that older ages, time of tooth brushing and sugar consumption were associated with having dental caries after controlling for other variables. The effects of fathers' education, gender, accompanied disease and dry mouth were not significant on dental caries. In conclusion, dental caries in children aged 6-12 years old was prevalent in the studied district and found to be a public health problem. Sugar consumption, time spent tooth brushing, and older ages were important factors associated with dental caries. Comprehensive and effective strategies will be needed to reduce the sugar consumption among children.
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