• The Korean Journal of Applied Statistics
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• v.22 no.4
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• pp.793-804
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• 2009

The hypotheses of difference, ratio and odds ratio between two proportions are used for the non-inferiority trial. The approximate unconditional test suggested by Kang and Chen (2000) based on difference and ratio have the potential problem against the failure rate. When the sample size is small, the type I errors of the asymptotic test using the normal approximation suggested by Chen et al. (2000) tends to exceed the nominal level. Therefore, we propose the approximate unconditional test based on odds ratio and compare the test with the asymptotic test. And we compare the three hypotheses used in the approximate unconditional tests of two proportions with respect to the type I errors and power.

• The Korean journal of internal medicine
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• v.39 no.2
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• pp.238-247
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• 2024

Background/Aims: Small rectal neuroendocrine tumors (NETs) can be treated with modified endoscopic mucosal resection (EMR). However, an optimal EMR method remains to be established. We aimed to assess the non-inferiority of Tip-in EMR versus precut EMR (EMR-P) for treating rectal NETs. Methods: This prospective, multicenter, randomized controlled trial enrolled patients with rectal NETs of < 10 mm in diameter. The patients were randomly assigned to EMR-P and Tip-in EMR groups in a 1:1 ratio. Primary outcome was margin-negative (R0) resection rate between the two methods, with a noninferiority margin of 10%. Results: Seventy-five NETs in 73 patients, including 64 eligible lesions (32 lesions in each, EMR-P and Tip-in EMR groups), were evaluated. In a modified intention-to-treat analysis, R0 resection rates of the EMR-P and Tip-in EMR groups were 96.9% and 90.6%, respectively, which did not demonstrate non-inferiority (risk difference, -6.3 [95% confidence interval: -18.0 to 5.5]). Resection time in the EMR-P group was longer than that in the Tip-in EMR group (p < 0.001). One case of intraprocedural bleeding was reported in each group. Conclusions: We did not demonstrate the non-inferiority of Tip-in EMR compared to EMR-P for treating small rectal NETs. However, the R0 resection rates for both techniques were high enough for clinical application.

• Korean Circulation Journal
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• v.52 no.5
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• pp.354-364
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• 2022

Background and objectives: To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). Methods: This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. Results: We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. Conclusions: The Osstem Cardiotec Centum is non-inferior to the Xience Alpine^® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.

• Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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• v.33 no.3
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• pp.130-141
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• 2022

Voice and speech therapy can be performed in various ways depending on the situation, although it is generally performed in a face-to-face manner. Telepractice refers to the provision of specialized voice and speech therapy by speech-language pathologists for assessment, therapy, and counseling by applying telecommunication technology from a remote location. Recently, due to the pandemic situation and the active use of non-face-to-face platforms, interest in telepractice of voice and speech therapy has increased. Moreover, a growing body of literature has been advocating its clinical usefulness and non-inferiority to traditional face-to-face intervention. In this review, the existing discussions, guidelines, and preliminary studies on non-face-toface voice and speech therapy were summarized, and recommendations on the tools for telepractice were provided.

• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.145-156
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• 2014

Objectives : The aim of this study was to compare Tianwangbuxin-dan to Fluoxetine for antidepressive efficacy and safety in poststroke depression (PSD). Methods : A randomized, double blinded, non-inferiority trial was conducted. 113 PSD patients were recruited from a stroke center. Except for the 25 excluded patients, 88 PSD patients were randomly given either Tianwangbuxin-dan 1100 mg or Fluoxetine 20 mg per a day for 16 weeks. PSD was evaluated using Beck's depression inventory (BDI) and Hamilton depression rating scale (HDRS) and followed every fourth week. Repeated measure analysis of variance (ANOVA) was used to compare and contrast the depression scores of the two groups and to compare them among the evaluation times, at the beginning, $4^{th}$, $8^{th}$, $12^{th}$ and $16^{th}$ weeks. In addition, independent t-tests were used to find the difference between two groups at every evaluation time. Results : Finally, 88 PSD patients were included in the study, 63 PSD patients completed the procedure and 25 PSD patients were dropped out by the incompliance or withdrawal of consent. Tianwangbuxin-dan (or Fluoxetine) improved the depression of stroke patients and the efficacy of Tianwangbuxin-dan was not inferior to that of Fluoxetine. In addition, there was no significant side effect in two groups. Conclusions : This study showed that antidepressive efficacy and safety of Tianwangbuxin-dan in PSD patients.

• International Journal of Industrial Entomology and Biomaterials
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• v.38 no.1
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• pp.14-17
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• 2019

Oral gargling solution has been used for the control of halitosis. The purpose of this study was to compare the level of hydrogen sulphide concentration between silk oral gargling solution and commercially available oral gargling solution. Total 21 volunteers were included in this study. The relative level of hydrogen sulphide concentration was calculated to the baseline level. In terms of the primary endpoint of the trial, relative level of hydrogen sulphide concentration was $50.84{\pm}33.19%$ with silk group, versus $71.07{\pm}21.83%$ with Listerine group ($P_{non-inferiority}=0.003$). In conclusion, the results of oral gargling with a silk protein for healthy individual were non-inferior to oral gargling with Listerine for hydrogen sulphide concentration reduction.

• Journal of Preventive Medicine and Public Health
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• v.37 no.4
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• pp.381-389
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• 2004

Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

• Archives of Craniofacial Surgery
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• v.23 no.4
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• pp.152-162
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• 2022

Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

• 대한예방의학회:학술대회논문집
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• 2001.10a
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• pp.302-304
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• 2001

• Proceedings of the Korean Statistical Society Conference
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• 2003.10a
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• pp.319-324
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• 2003

본 논문에서는 matched-pair design에서의 두 처리간 동등성/ 비열등성 검정에 대해 고려하였다. 기존에 비율차이나 risk ratio관점에서 동등성/비열등성 검정을 시행한 것과는 달리, 본 논문에서는 odds ratio에 기초하여 두 가지 검정통계량을 유도하였다. (1) constrained maximum likelihood estimator(mle)를 이용한 fieller type 통계량 (2) 제약없이 구한 mle를 사용한 wald-type 통계량). 비율 차이나 risk ratio에 기초한 기존의 통계적 방법들(비율차이에 근거한 (3) score-type 통계량과 (4) wald-type 통계량, risk ratio에 기초한 (5) fieller-type 통계량과 (6) wald-type 통계량)과 본 논문에서 제시한 두가지 통계량의 성능을 비교하기 위해 모의실험을 시행하였다. 모의실험 결과, 본 논문에서 제안한 constrained mle를 사용한 fieller type 통계량은 empirical type I error 측면에서 매우 만족스러운 결과를 보이고 있으며, 특히 비대각 셀의 확률이 작아질 경우에도 안정적인 성능을 보여준다.