• Title/Summary/Keyword: clinical sample

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Sample Size Calculations for the Development of Biosimilar Products Based on Binary Endpoints

  • Kang, Seung-Ho;Jung, Ji-Yong;Baik, Seon-Hye
    • Communications for Statistical Applications and Methods
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    • v.22 no.4
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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.

Order Communication System for Clinical Laboratory Tests (임상병리검사 처방전달 시스템)

  • 차은종;이태수
    • Journal of Biomedical Engineering Research
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    • v.14 no.4
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    • pp.355-364
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    • 1993
  • Clinical laboratory order communication system was developed to run fast and effective laboratory tests at the Chungbuk National University Hospital. The present system incorporated with the main Hospital Management Information System accepts :aboratory orders, classifies them based on the predefined logical system, and outputs various practical informations for the user. These assist sample taking, sample management, and work plan organization. A special care was taken to the sample management by introducing the bar code system. The system was written in the INFOS hierarchical database and COBOL, and is currently in the practical use for both in - and out-ward patients. The present system enabled fast and effective data communication as well as reducing the time and man power indispensable when the manual slips are used for order communication.

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An Improved Method for Constructing Confidence Interval of Median : Small Sample Case

  • Park, Sang-Gue;Choi, Ji-Yun
    • Journal of the Korean Data and Information Science Society
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    • v.15 no.4
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    • pp.973-980
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    • 2004
  • Phase I clinical trials are often pharmacologically oriented and usually attempt to find the best dose of drug to employ. However, other purposes like determination of sizes and types of side effects and toxicity and organ system involved are equally important. Estimation of treatment effects or side effects is usually ignored since it is usually based on too small sample, even though Phase II clinical trials would be designed based on the Phase I studies. Statistical methods for constructing the approximate confidence interval for population median in case of small sample are considered and an improved method is proposed. The proposed estimator is compared with current methods through simulation studies.

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The influence of the Clinical Learning Environment and Learning Transition on Satisfaction with a Gerontological Nursing Clinical Practicum in Nursing Students

  • Lee, Insook;KNAG, Yun
    • International Journal of Advanced Culture Technology
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    • v.10 no.2
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    • pp.43-52
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    • 2022
  • This study used a descriptive survey design to examine the impact of the clinical learning environments and learning transition nursing students experienced the gerontological nursing clinical on the satisfaction with clinical practice. A convenient sample of 211 4th year nursing students who had the gerontological nursing clinical practicum from one College of Nursing at Private University in South Korea was recruited and completed the surveys from October to December 2019. This study showed that the satisfaction with a gerontological nursing clinical practicum was significantly correlated with clinical learning environments and learning transition. The results of this study highlights the need to create a safe and positive clinical learning environment for quality gerontological nursing clinical practicum, so hospitals and nursing schools need to make efforts to promote clinical sites as an educational learning environment in collaborative relationships.

Sample Size Calculation in Medical Research (의학연구에서 표본크기 계산)

  • Pak, Son-Il;Oh, Tae-Ho
    • Journal of Veterinary Clinics
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    • v.29 no.1
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    • pp.68-77
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    • 2012
  • Whenever planning a study design or preparing a research proposal it is highly recommended that investigators decide the optimum sample size that is required to yield an outcome of interest with a predetermined level of precision. This is because that, all else being equal, if a study with less than the optimum sample size would not detect the significance of differences in reality, and similarly, if a study with more than the optimum sample size will be costly. For these reasons, the majority of peer reviewed biomedical journals assess the adequacy of sample size requirements. The calculated sample size is used as a target number of samples to be collected to provide an estimate of the parameter with the desired and predetermined level of accuracy, and the sample size is a major determinant of the probability of detecting diseased animals from the population. There is no single method of calculating sample size for any given study design. In this context, the purpose of this article is to provide a collection of formulas and examples for some typical situations likely to be encountered in veterinary clinical practice and to highlight the importance of performing prospective sample size calculations when planning a research. Specifically, this paper is concerned with the basic principle of sample size calculation, and considerations for methodological applications were illustrated for a given data set. Also included in this paper is factors influencing sample size calculations using a statistically valid techniques. Appropriate methods to consider these factors are presented.

The effect of Sojadodamgangkitang on the pulmonary injury caused by $SO_2$ in rats (소자도담강기탕(蘇子導痰降氣湯)이 $SO_2$에 의한 흰쥐의 호흡기손상(呼吸器損傷)에 미치는 영향(影響))

  • Park, Dong-Il;Kim, Bong-Jae
    • The Journal of Korean Medicine
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    • v.18 no.1
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    • pp.344-356
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    • 1997
  • This experiment was performed in order to study the clinical effect of Sojadodamgangkitang on the pulmonary injury caused by $SO_2$. Healthy adult male rats weighing about 250g were divided into 4 groups-the Normal group, the Control group, the group of Sojadodamgangkitang administration for 5 days after $SO_2$ gas exposure(Sample I), and the group of Sojadodamgangkitang administration for 10 days before and for 5days after $SO_2$ gas exposure(Sample II). The results were obtained as. follows; 1. In comparison with Control group, Sample I and Sample II were revealed significant effect on the total number of leucocyte. 2. In comparison with Control group, Sample I and Sample II were revealed significant effect on. the erythrocyte sedimentation rate. 3. In the effect on the lung weight, Sample I and Sample II were revealed significantly. 4. In the effect on the lung TBA level, only Sample II was revealed significantly. 5. In the effect on the tracheal glycoprotein level, Sample I and Sample II were revealed significantly. According to above results, Sojadodamgangkitang had significant effect on the pulmonary injury caused by $SO_2$ in rats.

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The Comparison of the Accuracy in Preparing Small Vancomycin Dosage : Single vs. Double Dilution Method (소용량 Vancomycin 주사액 조제방법의 차이에 의한 정확성 비교: 단일희석방법과 이중희석방법)

  • Shin, Hea Young;Suh, Ok Kyung;Lee, Suk Hyang;Shin, Hyun Taek
    • Korean Journal of Clinical Pharmacy
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    • v.7 no.2
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    • pp.86-90
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    • 1997
  • This study was to find a more accurate method fur measuring small vancomycin dosages which are commonly used in neonates by comparing single and double dilution method. For single dilution method, 500 mg of vancomycin powder was accurately measured and reconstituted with 5 ml of distilled water to make a concentration of 100 mg/ml. Volumes of 0.05, 0.1, 0.15, 0.2, 0.3, 0.4, and 0.5 ml, which equal the target dosages of 5, 10, 15, 20, 30, 40, and 50 mg, were measured using syringes made by Shina and each sample was further diluted with 2 ml of $5\%$ dextrose. The solution of 100 mg/ml concentration was further diluted with $5\%$ dextrose to make a concentration of 20 mg/ml. Volumes of 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, and 2.5 ml, which correspond to 5, 10, 15, 20, 30, 40, and 50 mg, were sampled by the same Shina's syringe as in single dilution method and then each sample was further diluted to make a total volume of 10 ml. Each sample was analyzed by HPLC. The measured dosages of each sample in both single and double dilution methods were lower than the target dosages; however, e values in double dilution method were higher than those in single dilution method for seven target dosages. Percent target dosages in single dilution method were 65 to $90\%$, while in double dilution method 91 to $94\%$. Statistically significant difference between two groups was shown in 5, 10, 15, 20, and 40 mg dosages (p<0.05). In conclusion, when preparing small vancomycin dosages lower an 20 mg $(volume{\leq}0.2\;ml)$, using Shina's syringes, the double dilution method has a closer value to the target dosage than single dilution method.

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Study for the sampling method using simulation in clinical data (시뮬레이션을 이용한 임상자료의 샘플링 방법 연구)

  • Sohn, Ki-Cheul;Kim, Dal-Ho
    • Journal of the Korean Data and Information Science Society
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    • v.23 no.4
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    • pp.677-682
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    • 2012
  • There are lots of sampling design which is determined for sample survey in various fields. Especially, it is important problem for clinical data because basic characteristic variables by group which consist of experiment group and control group in population should be reflect to sample. Therefore, frequencies, center scales and dispersion scales of variables by group in population should be similar in sample. But usual sampling design is very complicate so it is difficult to use in practice for researcher. In this paper, we consider the sampling method using simulation. We applied the proposed method to colon cancer data from a hospital. We compare basic characteristic variables between population and sample with mean, frequency and statistic hypothesis test.

Clinical Nurse's Organizational Commitment and Influencing Factors (부산시내 일개 대학병원 간호사의 조직몰입에 영향을 미치는 요인)

  • Jung, Kwuy-Im;Oh, Chang-Seok
    • The Korean Journal of Health Service Management
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    • v.5 no.1
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    • pp.101-110
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    • 2011
  • This study was designed to identify organizational commitment and influencing factors in clinical nurses. A cross-sectional design was conducted with a sample of 322 clinical nurses randomly selected from university hospital in Korea. The tools used for this study were scales measuring organizational commitment(15 items), job satisfaction(41 items). The data were analyzed using SPSS 12.0 employing pearson correlation coefficients and multiple regression analysis. The mean score for organizational commitment in clinical nurses was 3.77 points. Factors influencing organizational commitment in clinical nurses were identified as job satisfaction(${\beta}$=.388), belief presence level(${\beta}$=.206). These factors explained 13.4% of organizational commitment reported by clinical nurses. The results indicate which factors are major factors influencing organizational commitment in clinical nurses. Therefore, these factors may serve as predictors of organizational commitment in clinical nurses.