• Title/Summary/Keyword: Non-inferiority

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A study on Noninferiority of Proportions (모비율의 NONINFERIORITY에 대한 연구)

  • 강승호
    • The Korean Journal of Applied Statistics
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    • v.16 no.1
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    • pp.117-128
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    • 2003
  • The goal of non-inferiority experiments is to show that the new treatment is not inferior to the standard experiment. In this paper we compare the three methods of variance estimation used in the unconditional exact tests of two proportions. The size and power of the tests with each variance estimation method are compared using complete enumeration.

A qualitative research on emotional labor and stress in dental hygienists (치과위생사의 감정노동 및 스트레스에 관한 질적 연구)

  • Han, Ok-Seong
    • Journal of Korean society of Dental Hygiene
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    • v.20 no.6
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    • pp.797-807
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    • 2020
  • Objectives: This qualitative research was conducted to understand the experiences of dental hygienists with respect to emotional labor and stress through in-depth interviews, and analyze experiences that are difficult to grasp in quantitative studies. Methods: From October 7 to October 14 2020, a total of seven study participants were selected and underwent in-depth interviews. A phenomenological research methodology was applied for intensive analysis. Results: The results of the interviews were grouped into five central-categories: relationships in the workplace (trouble with the staff, discrimination against staff, relationship between subordinates and superiors), relationships with non-major (trouble with laboratory staff, inferiority complex and behavior of non-specialists), emotional labor for the patient (patient-centered, patient selfishness, exquisite guardian), conduction of business (passing the work, deterioration in health due to emotional labor), organizing emotions (patience and a sense of collapse, conversation with a coworker). Conclusions: Based on this study, we need to develop tools to measure dental hygienists' emotional labor and stress as well as conduct follow-up research on ways to improve them.

Safety and Efficacy of the Mandibular Advancement Device 'Bioguard' for the Treatment of Obstructive Sleep Apnea : A Prospective, Multi-Center, Single Group, and Non-Inferiority Trial (폐쇄성 수면무호흡증의 치료에 사용되는 하악전방이동장치-'바이오가드'의 안전성과 유효성 검증을 위한 전향적, 다기관, 단일군 및 비열등성 연구)

  • Kim, Hyoung Wook;Hwang, Chungpoong;Eun, Hun Jeong
    • Sleep Medicine and Psychophysiology
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    • v.23 no.2
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    • pp.84-92
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    • 2016
  • Objectives: The purpose of this study was to estimate the safety and efficacy of a mandibular advancement device (MAD), 'Bioguard,' for the treatment of obstructive sleep apnea (OSA). Methods: In this 5-week prospective, multi-center, single group, and non-inferiority trial, patients who chose 'Bioguard' as their treatment option were evaluated using both questionnaires (Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale (ESS)) and polysomonography (PSG) (apnea hypopnea index (AHI), oxygen saturation). All patient data, including clinical records, PSG studies (both pre- and post-treatment), and adverse events (AEs), were reviewed and analyzed. Results: Results were obtained for 59 of 62 patients (95.16%). No significant difference in success rate was found between the MAD treatment and surgical treatment (95% CI). AHI, PSQI, ESS and oxygen saturation demonstrated significant improvement (p < 0.001) after MAD treatment, and 39 of 62 patients (62.9%) reported 85 AEs. 79 of the 85 AEs (91.8%) were mild cases, and there were no severe AEs related to the MAD treatment. Conclusion: The MAD 'Bioguard' should be considered as an alternative treatment option for OSA patients.

Analysis of the Higher Education Evaluation Accreditation System in Taiwan (대만 고등교육평가체제의 분석)

  • Choi, young-pyo
    • Korean Journal of Comparative Education
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    • v.18 no.4
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    • pp.163-186
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    • 2008
  • This study intends to understand deeply the higher education evaluation accreditation system in Taiwan. Taiwan established newly the Higher Education Evaluation & Accreditation Council in 2005, an independent organization with the exclusive responsibility to execute evaluation. Three kinds of evaluation have been accomplished, including University Program Evaluation which assesses whole university management, Academic Fields Evaluation and Performance Evaluation which compare the superiority and inferiority among universities. The Accreditation system is applied only to Academic Fields Evaluation. For evaluation, each university presents a self-evaluation report, undergoes an visiting evaluation, makes out an evaluation report and lastly is notified of the result. The evaluation is divided into three results : pass, waiting observation and non-pass. According to an announcement in June 2008, the rate of non-pass universities reached the 15.7%. The non-pass universities are supposed to receive the disadvantaged in the admission number limit and take the following evaluation in the following year. Debates still exists concerning the eliminatory nature of the system and the announcement of achievement rankings through evaluation results. Other problems include the improvement of quality of evaluation committee members and the irrational evaluation standards. These problems will be meaningful for the development of the korean higher evaluation system.

Matching-adjusted Indirect Comparison (MAIC) of Tralokinumab Versus Dupilumab for the Treatment of Moderate to Severe Adult Atopic Dermatitis (트랄로키누맙과 두필루맙의 매칭 조정 간접 비교)

  • Taekyung Kim;Keun Soo Shin;Hyojin Kim;Eugene Kim;Leejung Choi;Dong Hun Lee
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.3
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    • pp.178-185
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    • 2023
  • Objective: Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disease. Both tralokinumab and dupilumab have been recommended in the European Guideline for the treatment of adult patients with severe AD. In Korea, dupilumab has been approved for patients with moderate to severe AD, and reimbursed for those with severe AD. Since there is no clinical trial directly comparing tralokinumab and dupilumab, we conducted indirect comparison to assess the clinical usefulness in patients with AD. Methods: We selected clinical trials for indirect comparison through a systematic literature review. Individual patient data were available for the tralokinumab clinical trial, and aggregated data were available for the dupilumab clinical trial. Therefore, we employed the Matching-Adjusted Indirect Comparison (MAIC) method. The treatment efficacy was assessed based on whether patients achieved a 75% reduction on the Eczema Area and Severity Index (EASI 75) after drug administration. Results: The difference in the proportion of patients achieving EASI 75 between tralokinumab and dupilumab was 4.7% (95% CI: -7.9 to 17.3). Considering the non-inferiority margin for the EASI 75 achievement rate is -10%, tralokinumab is deemed non-inferior to dupilumab as the lower bound of the CI for the difference in the EASI 75 achievement rate between tralokinumab and dupilumab was within -10%. Conclusion: We conducted a MAIC analysis comparing tralokinumab and dupilumab based on EASI 75 achievement. The findings of this study show that tralokinumab is non-inferior to dupilumab and can be implemented in Korean clinical settings with a therapeutic position comparable to dupilumab.

A randomized, double-dummy, multicenter non-inferiority clinical trials to evaluate the efficacy and the safety of SKI 306X compared to diclofenac in patients with osteoarthritis of the knee (양측 눈가림, 무작위배정, 다기관공동 제 3상 임상시험 결과 - 퇴행성 관절염에 대한 SKI 306X정과 Diclofenac과의 비열등성 임상시험)

  • Jung Y.B.;Seong S.C.;Lee M.C.;Shin Y.U.;Kim D.H.;Kim J.M.;Jung Y.K.;Ahn J.H.;Seo J.G.;Park Y.S.;Lee C.S.;Roh K.J.;Han C.K.
    • 대한임상약리학회:학술대회논문집
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    • 2001.12a
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    • pp.24-25
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    • 2001
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Evaluation on the efficacy and safety of calcium metaphosphate coated fixture

  • Cho, In-Ho;Lee, Jae-Hoon;Song, Young-Gyun;Kim, Young-Mi;Jeon, So-Young
    • The Journal of Advanced Prosthodontics
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    • v.5 no.2
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    • pp.172-178
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    • 2013
  • PURPOSE. The purpose of this study was to assess the difference in efficacy between calcium metaphosphate (CMP)-coated implant fixtures and conventional resorbable blasted media (RBM) processed implant fixtures. MATERIALS AND METHODS. This study targeted 50 implants from 44 patients who visited Dankook University Dental Hospital. Implantations were done separately for RBM treated and CMP-coated implants, although their design was the same. Calcium metaphosphate has a quicker biodegradation process through hydrolysis compared to other phosphate calcium groups. For the first year of the implantation, the resorption volume of marginal bone analyzed via radiography and perio-test value were measured, under the check plan. Their analyses were composed of a non-inferiority trials test. A 95% level of reliability was used. RESULTS. In the comparative analysis of the resorption volume of marginal bone and the perio-test value, no statistically significant difference was found between the CMP-coated implants and RBM implants. CONCLUSION. One year after the implant placement, CMP-coated implants were found not to be inferior to the conventional RBM implants.

CAE Analysis on the Radius Curvature of Ununiformed wall-thickness Jar (불균일 측벽두께 Jar의 곡률반경에 따른 CAE 해석)

  • Shin, Nam-Ho;Choi, Seok-Jong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.7 no.6
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    • pp.1040-1046
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    • 2006
  • This paper is aimed to investigate the deformation caused by ununiform contraction of injection molding with highly big differences of thickness by the continuity of various curvature radius. By CAE analysis, the uniform cooling structure and optimum molding conditions are found for Jars made of SAN and PMMA materials and applied to the design of chill. In order toevaluate the molding pressure, resin temperature, molding temperature, cooling conditions, Moldflow program is applied. As results of experiments, the deformation and inferiority phenomena in Jars are analyzed for each factor and proposed the injection molding conditions to minimize the cooling structure and reduce the cycle time.

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Non-inferiority study of the efficacy of two hyaluronic acid products in post-extraction sockets of impacted third molars

  • Yang, Hyunwoo;Kim, Junghun;Kim, Jihong;Kim, Dongwook;Kim, Hyung Jun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.42
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    • pp.40.1-40.5
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    • 2020
  • Background: Hyaluronic acid (HA) is well known to exert an anti-inflammatory effect during oral wound healing and is commonly applied after tooth extraction. However, no double-blind randomized controlled study comparing two hyaluronate mouthwash products has been conducted so far. The aim of this study was to comparatively analyze the efficacy of Mucobarrier® and Aloclair® in terms of clinical symptoms. Results: A total of 112 patients were randomly assigned to assess the degree of discomfort, pain reduction, redness, burning sensation, and swelling between two groups on the day of surgery and 7 days later in a double blind test, with a total 56 Aloclair patients and 56 Mucobarrier patients. There was no statistically significant difference in the overall discomfort, degree of pain reduction, redness, burning sensation, and swelling between the Mucobarrier and Aloclair groups. Conclusion: The local application of hyaluronic acid mouth wash after wisdom tooth extraction is beneficial in reducing overall discomfort and pain reduction, and the clinical utility of Mucobarrier® is no different from Aloclair®. Trial registration: Institutional Review Board of Yonsei University College of Dentistry, 2-2018-0036. Registered 10 September 2018-prospectively registered, https://eirb.yuhs.ac/

A Study on Relationship Between Fear During Pregnancy and Person and Environmental Variables in Pregnant Women (임부의 공포와 개인 및 환경변인의 상오관계에 관한 연구)

  • 정송자
    • Journal of Korean Academy of Nursing
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    • v.4 no.2
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    • pp.131-143
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    • 1974
  • Antenatal care is zoomed toward3 assisting the Individual to achieve safe and wholesome state of health during pregnancy. Nature of fear is assumed to be rooted to complex interaction between past experiences, human relationship and present state of health, however. specific relationship between fear and the variables have not yet been ascertained. This study is designed to investigate the nature of fear of pregnancy, and the correlation between fear and the personal and environmental variables such as personal characteristics past experiences. and psycho-social factors. During the period from October 23 to November 5, 215 pregnant and 104 non-pregnant women of similar chronological are group residing in Seoul were interviewed according to check-list by random General anxiety test, general personality test and test for fear of pregnancy, family according to specific variables such as past experiences of Pregnancy and childbirth, structure of family, family relationship and month of pregnancy was done to the group of pregnant women. To non-pregnant group, general anxiety test was performed to compare with pregnant group. Results of the study are as follows; 1. Hypothesis 1; Degree of general anxiety will be higher e pregnant women compared to that of non-pregnant women. There is no significant difference between the general anxiety of pregnant women and that of non-pregnant women. Therefore, hypothesis I is rejected. 2. Hypothesis 2: Fear of pregnancy and general anxiety will be correlated with personality factors. Through test for fear of pregnancy and general anxiety, a meager contra-correlation between fear and only two personal factors (R and E factor) is revealed but there is no significant correlation between fear and other personal factors (A.S. and T factor). Degree of fear of pregnancy tends to b: higher in the group with low personality factors; responsibility and emotional stability expect the correlation between ascendancy, sociability, and confidence-inferiority. non-significant. Through general anxiety test, level of general anxiety tends to be higher in the group. with low personality factors; responsibility. emotional stability, and confidence except ascendency and sociability, non-significant. Hypothesis 2 is partially supported. 3. Hypothesis 3; General anxiety and fear of pregnancy will be correlated with the past experience-ol pregnancy, and child-birth experience. Though general anxiety test and test for fear of pregnancy, non-significant difference is revealed by P〉.05 level Hypothesis 3 is rejected. 4. Hypothesis 4: General anxiety and fear of pregnancy will be correlated with the month at pregnancy will be correlated with the month of pregnancy. Through tests of general anxiety and fear, significant correlation is revealed degree of fear by-P〈.05 level (CR=1.98) and level of general anxiety by P〈.005 level (CR=3. 11) is higher in the earlier stage of pregnancy. Hypothesis 4 is supported. 5. Hypothesis 5, 6, 7; General anxiety and fear of pregnancy will be correlated with socio-economic status, family structure, and family relationship. Through general anxiety test and tear of pregnancy test, non-significant is revealed by P〉.05 level. Hypothesis 3.6.7 are rejected. Conclusion and recommendation Level of general: anxiety and degree of fear of pregnancy is shown not to be correlated with variables of past experiencers of pregnancy and child-birth. and family factors except the month of - pregnancy. Personal characteristics are shown to be partially contra-correlated meagerly with genera anxiety and fear of pregnancy. This study revealed contrasted results, in regard to presence of correlation between general anxiety and fear of pregnancy to other thesis. In this context. further studies under controlled environment is recommended.

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