• Title/Summary/Keyword: statistical confidence

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Bioequivalence of Losazol Tablet to Pletaal Tablet (Cilostazol 50 mg) (프레탈 정(시로스타졸 50 mg)에 대한 로사졸 정의 생물학적 동등성)

  • Kim, Soo-Jin;Lim, Dong-Koo;Oh, In-Joon;Cho, Haeng-Nam;Suh, Soon-Pal;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.28 no.3
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    • pp.193-198
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    • 1998
  • Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co., Ltd.) and the $Losazol^{TM}$ (Kyoung Dong Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age $20{\sim}28$ years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 50 mg of cilostazol were orally administered, blood was taken at predetermined time intervals and the concentration of cilostazol in plasma was determined with an HPLC method using UV detector. The pharmacokinetic parameters $(C_{max},\;T_{max}\;and\;AUC_t)$ were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max},\;T_{max}\;and\;AUC_t$ between two tablets were 3.14%, 10.0% and 7.35%, respectively. The powers $(1-{\beta})$ for $C_{max},\;T_{max}\;and\;AUC_t$ were 89.67%, 80.97% and 83.87%, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than 20% except $T-{max}$, but confidence interval of $T_{max}$ was also less than 20% at the significance $level({\alpha})$ of 0.1. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Losazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM} tablet$.

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Recovery and Return to Work After a Pelvic Fracture

  • Papasotiriou, Antonios N.;Prevezas, Nikolaos;Krikonis, Konstantinos;Alexopoulos, Evangelos C.
    • Safety and Health at Work
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    • v.8 no.2
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    • pp.162-168
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    • 2017
  • Background: Pelvic ring fractures (PRFs) may influence the daily activities and quality of life of the injured. The aim of this retrospective study was to explore the functional outcomes and factors related to return to work (RTW) after PRF. Methods: During the years 2003-2012, 282 injured individuals aged 20-55 years on the date of the accident, were hospitalized and treated for PRFs in a large tertiary hospital in Athens, Greece. One hundred and three patients were traced and contacted; 77 who were on paid employment prior to the accident gave their informed consent to participate in the survey, which was conducted in early 2015 through telephone interviews. The questionnaire included variables related to injury, treatment and activities, and the Majeed pelvic score. Univariate and multiple regression analyses were used for statistical assessment. Results: Almost half of the injured (46.7%) fully RTW, and earning losses were reported to be 35% after PRF. The univariate analysis confirmed that RTW was significantly related to accident site (labor or not), the magnitude of the accident's force, concomitant injuries, duration of hospitalization, time to RTW, engagement to the same sport, Majeed score, and complications such as limp and pain as well as urologic and sexual complaints (p < 0.05 for all). On multiple logistic regression analysis, the accident sustained out of work (odds ratio: 6.472, 95% confidence interval: 1.626-25.769) and Majeed score (odds ratio: 3.749, 95% confidence interval: 2.092-6.720) were identified as independent predictive factors of full RTW. Conclusion: PRFs have severe socioeconomic consequences. Possible predictors of RTW should be taken into account for health management and policies.

Attitude of the TV Advertising and Purchasing Behavior of Housewives (主婦의 TV廣告에 대한 態度 및 그에 따른 購買行動)

  • Kang, Mi-Ock;Lee, Seung-Sin
    • Journal of Families and Better Life
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    • v.9 no.1 s.17
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    • pp.187-202
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    • 1991
  • The purpose of this study is to analyze what attitude housewives hove to the TV advertisement and how their purchasing behavior is proceeding by information acquisition. Questionaire survey method was used in this research. The sample was taken from 437 housewives living is Seoul, form 4th of Feb. to 13th of Feb, in 1991. Used statistical methods were Frequency, Percentage, Crosstabs, One-way Anova, Duncan-test, and Regression Analysis. The major findings are summarized as follows : 1) The attitude to the TV advertisement according to the socio-demographic variables : TV advertisement seeing and hearing, the necessity of TV advertisement, and the attitude to the new advertisement are all found significant difference by age and education. The feeling to the false of TV advertisement is found significant difference by age, education, and income. 2) The purchasing behavior with TV advertisement information is most influenced by utilization of TV advertisement for all four goods(home medicine, milk product, detergent, durable goods). 3) The interest to the TV advertisement according to the TV advertisement information acquired: The degree to the utilization of TV advertisement and the necessity of TV advertisement when they buy goods were most influenced by conversation about the TV advertisement. 4) The purchasing behavior to the TV advertisement information acquired : The degree of influence was more affected by conversation about the TV advertisement for four goods, The degree of confidence was influenced by conversation about the TV advertisement for four goods. The degree of confidence was influenced by conversation about the TV advertisement for house medicine and detergent. The degree of satisfaction was not significant for all four goods, and the comparative appraisement was influenced by conversation about the TV advertisement for detergent and durable goods.

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Chuna Manual Therapy for Stroke: A Systematic Review and Meta-analysis (뇌졸중의 추나요법에 대한 체계적 문헌 고찰)

  • Kim, Mi-Kyung;Han, Chang-Ho
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.14 no.2
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    • pp.15-28
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    • 2019
  • Objectives : This study aimed to systematically and comprehensively review controlled clinical trials on the effectiveness and safety of Chuna Manual Therapy for stroke. Methods : By October 7, 2019, three core databases and three domestic databases were searched. Seven major academic journals on the related field were also hand-searched. Methodological quality of the included studies was evaluated using the Cochrane risk of bias tool. Meta-analysis was conducted and the quality of its evidence was assessed using the GRADE methodology. Results : Five articles met the eligibility criteria. The results of most of included studies were in favor of Chuna Manual Therapy. No study described any adverse events during or after the clinical trials. Meta-analysis of three eligible studies showed that the pre- and post-treatment scores on the Modified Barthel Index (mean difference 8.00, 95% confidence interval 0.26 to 15.74) and Berg Balance Scale (mean difference 3.57, 95% confidence interval 0.64 to 6.51) of the Chuna-treated group were significantly different, but only marginally higher than those of the non-treatment group. Thus, the level of evidence gathered from these studies was assessed to be low. Conclusions : Based on current available evidence, any confirmative conclusions cannot be made on the effectiveness and safety of Chuna Manual Therapy for stroke because of the small sample size, low methodological quality, presence of statistical heterogeneity, and missing safety information. More rigorously designed large-scale multi-center studies are needed to establish more specific and credible evidence to support or oppose the use of Chuna Manual Therapy for stroke.

Sample size for serological surveillance of Aujeszky's disease in Korea (국내 돼지오제스키병의 혈청학적 감시활동(surveillance)을 위한 표본크기)

  • Kim, Eu-Tteum;Pak, Son-Il;Park, Choi-Kyu;Kweon, Chang-Hee
    • Korean Journal of Veterinary Research
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    • v.47 no.4
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    • pp.417-423
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    • 2007
  • Serological surveillance programs in animal populations are becoming increasingly important to estimate prevalence of a specific disease and subsequently to document disease-free status in a region or a country. For these purposes, the programs need to be based on both theoretical and economical aspects from the designing phase. From Aujeszky's disease (AD)-eradication program point of view, group of animals (aggregates, herds) not individual animal is the more important sampling unit of concern. In this study the authors therefore attempted to compute an appropriate sample size tailored to a current surveillance program against AD, assuming that the goal of this program is either herd-level prevalence estimation or documentation of AD-freedom. For prevalence estimation, assuming a finite population with imperfect sensitivity (Se) and specificity (Sp) of ELISA kit for AD diagnosis, the number of herds present, expected herd prevalence, and desired accuracy for a certain level of confidence, sample size was estimated at herd-level in the first stage and individual animal-level in the second stage. A two-stage sampling design was used to calculate a sample size to indicate AD-freedom. In this instance, the computation was based on the possible detection of a predetermined prevalence at a certain herd-level Se and Sp. This study indicated that the sample size varied with predetermined confidence, tolerance, Se and Sp at herd- and animal-level, and within- and among-herd prevalence. In general, smaller sample size was required to estimate AD prevalence than to document of AD-freedom. Compared to individual-based samples, two-stage sampling strategy requires a larger sample size to show disease-freedom. Statistical considerations including herd-level test characteristics when designing surveillance program also are further discussed.

Assessment of Gait as a Diagnostic Tool for Patients with Dementia (치매 진단도구로서 치매노인의 보행능력 평가에 대한 연구)

  • Lee, Han-Suk;Park, Sun-Wook
    • Journal of the Korean Society of Physical Medicine
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    • v.12 no.2
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    • pp.129-136
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    • 2017
  • PURPOSE: The purpose of this study was to compare the gait of elderly patients with and without dementia to investigate the possibility of an ambulation assessment test as a diagnostic tool for dementia. METHODS: A total of 96 subjects were included with 60 participants without dementia (control group) and 36 patients with dementia (dementia group). To compare the walking ability of the two groups, a 4-m walking test (4MWT) and Groningen Meander Walking Test (GMWT) were conducted. The GMWT is graded by amount of time in seconds and by number of oversteps outside the track. Mann-Whitney U test was used to compare the gait between the groups and the area under the curve (AUC) with Received Operating Characteristic (ROC) curve was analyzed. Statistical significance was considered at a p<.05, with a 95% confidence interval. RESULTS: There were statistically significant differences (p<.05) between the dementia group and the control group for the 4MWT, GMWTSEC, and GMWTSTEP scores. The AUC was .95 for 4MWT, .92 for GMWTSEC, and .96 for GMWTSTEP with the 95% confidence interval. The cut-off values of the ROC curve were 1.03m/s for 4MWT, 10.8 second for GMWTSEC, and 3.75 steps for GMSTEP. CONCLUSION: In our study, we investigated the utility of ambulatory assessment tools to predict dementia. The results of this study suggest that the 4MWT and the GMWT used in this study are appropriate assessment tools for dementia prediction.

Bioequivalence Evaluation of Two Brands of Cefixime 100 mg Capsule (Suprax and Alpha-Cefixime) in Korean Healthy Volunteers

  • Choi, Dong-Hyun;Burm, Jin-Pil
    • Biomolecules & Therapeutics
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    • v.15 no.3
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    • pp.182-186
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    • 2007
  • Cefixime is an orally absorbed cephalosporin with a broad spectrum of activity against Gram-negative bacteria and is highly resistant to beta-lactamase degradation. The purpose of the present study was to evaluate the bioequivalence of two cefixime capsules, Suprax capsule (Dong-A Pharmaceutical Co., reference drug) and Alpha-Cefixime capsule (Alpha Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal subjects, $23.5{\pm}3.72$ years in age and $68.3{\pm}8.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. There was one week washout period between the doses. After one capsule containing 100 mg of cefixime was orally administered, plasma was taken at predetermined time intervals and the concentrations of cefixime in plasma were determined using HPLC with UV detector. The pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_{t}$, $C_{max}$ and $T_{max}$ between two products were -3.91%, -2.23% and -3.18%, respectively, when calculated against the reference drug. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of $log0.8{\leq}{\delta}{\leq}log1.25$ (e.g., $log0.8786{\leq}{\delta}{\leq}log1.0523$ and $log0.8889{\leq}{\delta}{\leq}log1.0512$ for $AUC_{t}$ and $C_{max}$, respectively). The 90% confidence intervals using untransformed data was within ${\pm}20%$(e.g., $-10.37%{\leq}{\delta}{\leq}6.73%$ for $T_{max}$). All parameters met the criteria of KFDA for bioequivalence, indicating that Alpha-Cefixime capsule (Alpha Pharmaceutical Co.) is bioequivalent to Suprax capsule (Dong-A Pharmaceutical Co.).

Extracting the Risk Factor of Ground Excavation Construction and Confidence Analysis using Statistical Test Procedure (지반굴착공사 위험요소 도출 및 통계적 검정 방법을 통한 신뢰성 분석)

  • Kim, Dong-Min;Kim, Woo-Seok;Baek, Yong
    • Journal of Korean Society of Disaster and Security
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    • v.10 no.1
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    • pp.11-17
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    • 2017
  • The case study on ground subsidence was conducted and the cause of ground subsidence was evaluated, main cause were insufficient site exploration, inaccurate strength parameters, defective temporary wall, insufficient reaction for boiling and heaving, excessive excavation and so on. Risk factors during excavation were identified from the cause of ground subsidence and risk factors were site exploration, selecting excavation method, structure analysis, measurement plan, excavation method construction, underground water level change, natural disaster and construction management. The survey of the experts on risk factors identified was conducted to evaluate the importance of risk factors, and confidence analysis was performed to evaluate the significance level between survey result and survey respondent using Chi-square Test.

Development and Evaluation of a Hospice and Palliative Care Music Therapy Education Program

  • Kim, Eun Jung;Lee, Eun Jeong;Lee, Chung-Woo;Choi, Youn Seon
    • Journal of Hospice and Palliative Care
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    • v.23 no.1
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    • pp.17-26
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    • 2020
  • Purpose: This study was conducted to develop a hospice music therapist training program and to evaluate its effects. Methods: The educational program consisted of training on the theory of hospice and the theory and practice of hospice music therapy. The course lasted for 4 weeks, with 8 hours of training per week, and 33 music therapists completed the course. In order to assess the effectiveness of the course, participants' knowledge and confidence regarding hospice music therapy and readiness for hospice music therapy before and after education were measured. The statistical analysis was done using SPSS version 18.0 and the paired t-test was used to assess the effectiveness of the program. Results: The trainees showed significant improvements in knowledge (P<0.001) and confidence (P<0.001) in all areas of this course, as well as in readiness for hospice music therapy (P<0.001). Participants' satisfaction with the lectures was assessed using a 5-point Likert scale. The average score for all lecture areas exceeded 4 (yes), and the satisfaction level was mostly high. Students were most satisfied with the lectures on music therapy theory, followed in order by those on music therapy practice and hospice theory. Conclusion: This hospice music therapist training program is considered to be suitable because of its positive educational effects and the high satisfaction of participants with the lectures. In order to provide high-quality music therapy services to patients and their families, this training course should be regularly offered to cultivate competent music therapists, and the content of the education should be standardized and applied in various clinical settings.

Bioequivalence of Dybis Tablet (Metformin Hydrochloride 500 mg) (다이비스 정 (염산메트폴민 500 mg)의 생물학적 동등성)

  • 최준식;박영진;박상묵;범진필
    • YAKHAK HOEJI
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    • v.47 no.4
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    • pp.239-243
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    • 2003
  • Metformin is an oral antihyperglycemic agent used in the therapy of noninsulin-dependent diabetes mellitus and does not cause hypoglycemia at the therapeutic dose. The purpose of the present study was to evaluate the bioequivalence of two metformin hydrochloride tablets, Glucophage tablet (DaeWoong Pharmaceutical Co., reference drug) and Dybis tablet (Shinpoong Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration(KFDA). Twenty-four normal volunteers, 26.6$\pm$4.01 years in age and 60.6$\pm$9.80 kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 500 mg of metformin hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of metformin hydrochloride in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUCt, Cmax and Tmax between two products were -1.05%, -6.76% and -4.51%, respectively, when calculated against the reference drug. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8$\leq$$\delta$$\leq$log1.25 (e.g., log0.9082$\leq$$\delta$$\leq$log1.0906 and log0.8188$\leq$$\delta$$\leq$log1.0392 for $AUC_{t}$ and $C_{max}$, respectively). The 90% confidence intervals using untransformed data was within $\pm$20% (e.g., -17.66%$\leq$$\delta$$\leq$8.63% for $T_{max}$). All parameters met the criteria of KFDA for bioequivalence, indicating that Dybis tablets (Shinpoong Pharmaceutical Co.) is bioequivalent to Glucophage tablets (DaeWoong Pharmaceutical Co.).