• Communications for Statistical Applications and Methods
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• 제22권4호
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• pp.389-399
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• 2015

It is important not to overcalculate sample sizes for clinical trials due to economic, ethical, and scientific reasons. Kang and Kim (2014) investigated the accuracy of a well-known sample size calculation formula based on the approximate power for continuous endpoints in equivalence trials, which has been widely used for Development of Biosimilar Products. They concluded that this formula is overly conservative and that sample size should be calculated based on an exact power. This paper extends these results to binary endpoints for three popular metrics: the risk difference, the log of the relative risk, and the log of the odds ratio. We conclude that the sample size formulae based on the approximate power for binary endpoints in equivalence trials are overly conservative. In many cases, sample sizes to achieve 80% power based on approximate powers have 90% exact power. We propose that sample size should be computed numerically based on the exact power.

• Communications for Statistical Applications and Methods
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• 제22권6호
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• pp.605-613
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• 2015

A three-arm parallel design has been proposed to assess the biosimilarity between a biological product and a reference product using relative distance (Kang and Chow, 2013). The three-arm parallel design consists of two arms for the reference product and one arm for the biosimilar product. This paper extended the three-arm parallel design to a (k + 1)-arm parallel design composed of k (${\geq}3$) arms for the reference product and one arm for the biosimilar product. A new relative distance was defined based on Euclidean distance; consequently, a corresponding test procedure was developed based on asymptotic distribution. Type I error rates and powers were investigated both theoretically and empirically.

• Communications for Statistical Applications and Methods
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• 제27권1호
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• pp.1-14
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• 2020

Investigations of biosimilarity between reference drugs and test drugs required statistical tests; in addition, statistical tests to evaluate biosimilarity have been recently proposed. Ordinal outcome data has been observed in research; however, appropriate statistical tests to deal with ordinal endpoints for biosimilar have not yet been proposed. This paper extends existing design for ordinal endpoints. Using measure of nominal-ordinal association and relative distances between drugs are defined so that testing procedures are developed. Through simulation studies, we investigate type I error rate and power to show the performance of our suggested method. Furthermore, a comparison between the statistical tests and other designs is proviede to show significance of ordinal endpoints.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제24권4호
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• pp.357-365
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• 2021

Purpose: A change in diagnosis from ulcerative colitis (UC) to Crohn's disease (CD) has been reported in pediatric inflammatory bowel disease; however, only a few clinical characteristics and predictors of this diagnostic change have been reported. We aimed to describe the clinical characteristics of patients with UC who underwent a change in diagnosis to CD and identify variables associated with the change. Methods: The medical records of pediatric patients with UC who were followed up at the National Center for Child Health and Development between 2006 and 2019 were retrospectively reviewed. Clinical data on disease phenotype, laboratory parameters, endoscopic findings, and treatment of patients whose diagnosis changed to CD (cCD) were compared to those of patients whose diagnosis remained UC (rUC). Results: Among the 111 patients initially diagnosed with UC, 11 (9.9%) patients were subsequently diagnosed with CD during follow-up. There was no significant difference between the cCD and rUC groups in terms of sex, age at initial diagnosis, and the extent and severity of disease at initial diagnosis. Albumin and hemoglobin levels were significantly lower in the cCD group than in the rUC group. The proportion of patients who required biologics was significantly higher in the cCD group than in the rUC group (p<0.05). Conclusion: Approximately 10% children initially diagnosed with UC were subsequently diagnosed with CD. Hypoalbuminemia and anemia at initial diagnosis and use of biologics could be predictors of this diagnostic change.

• Journal of Korean Neurosurgical Society
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• 제64권4호
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• pp.495-504
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• 2021

Three-dimensional printing (3DP) applications possess substantial versatility within surgical applications, such as complex reconstructive surgeries and for the use of surgical resection guides. The capability of constructing an implant from a series of radiographic images to provide personalized anatomical fit is what makes 3D printed implants most appealing to surgeons. Our objective is to describe the process of integration of 3DP implants into the operating room for spinal surgery, summarize the outcomes of using 3DP implants in spinal surgery, and discuss the limitations and safety concerns during pre-operative consideration. 3DP allows for customized, light weight, and geometrically complex functional implants in spinal surgery in cases of decompression, tumor, and fusion. However, there are limitations such as the cost of the technology which is prohibitive to many hospitals. The novelty of this approach implies that the quantity of longitudinal studies is limited and our understanding of how the human body responds long term to these implants is still unclear. Although it has given surgeons the ability to improve outcomes, surgical strategies, and patient recovery, there is a need for prospective studies to follow the safety and efficacy of the usage of 3D printed implants in spine surgery.