• Title/Summary/Keyword: Randomized response

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Optimized Image-Based Surrogate Endpoints in Targeted Therapies for Glioblastoma: A Systematic Review and Meta-Analysis of Phase III Randomized Controlled Trials

  • Chong Hyun Suh;Ho Sung Kim;Seung Chai Jung;Choong Gon Choi;Sang Joon Kim;Kyung Won Kim
    • Korean Journal of Radiology
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    • v.21 no.4
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    • pp.471-482
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    • 2020
  • Objective: We aimed to determine the optimized image-based surrogate endpoints (IBSEs) in targeted therapies for glioblastoma through a systematic review and meta-analysis of phase III randomized controlled trials (RCTs). Materials and Methods: A systematic search of OVID-MEDLINE and EMBASE for phase III RCTs on glioblastoma was performed in December 2017. Data on overall survival (OS) and IBSEs, including progression-free survival (PFS), 6-month PFS (6moPFS), 12-month PFS (12moPFS), median PFS, and objective response rate (ORR) were extracted. Weighted linear regression analysis for the hazard ratio for OS and the hazard ratios or odds ratios for IBSEs was performed. The associations between IBSEs and OS were evaluated. Subgroup analyses according to disease stage (newly diagnosed glioblastoma versus recurrent glioblastoma), types of test treatment, and types of response assessment criteria were performed. Results: Twenty-three phase III RCTs published between 2000 and 2017, including 8387 patients, met the inclusion criteria. OS showed strong correlations with PFS (standardized β coefficient [R] = 0.719), 6moPFS (R = 0.647), and 12moPFS (R = 0.638). OS showed no correlations with median PFS and ORR. In subgroup analysis according to types of therapies, PFS showed the highest correlations with OS in targeted therapies for cell cycle pathways (R = 0.913) and growth factor receptors and their downstream pathways (R = 0.962). 12moPFS showed the highest correlation with OS in antiangiogenic therapy (R = 0.821). The response assessment in neuro-oncology criteria provided higher correlation coefficients between OS and IBSEs than the Macdonald criteria. Conclusion: Overall, PFS is an optimized IBSE in targeted therapies for glioblastoma; however, 12moPFS is optimal in antiangiogenic therapy.

MVP Chemotherapy and Hyperfractionated Radiotherapy for Stage III Unresectable Non-Small Cell Lung Cancer - Randomized for Maintenance Chemotherapy vs. Observation; Preliminary Report (제 3 기의 진행성 비소세포 폐암에서의 MVP 복합 항암 용법과 다분할 방사선 치료 -추가 항암 요법에 대한 임의 선택-)

  • Choi, Euk-Kyung;Chang, Hye-Sook;Suh, Cheol-Won;Lee, Kyoo-Hyung;Lee, Jung-Shin;Kim, Sang-Hee;Choi, Chul-Joon;Koh, Youn-Suck;Kim, Woo-Sung;Kim, Won-Dong;Kim, Sam-Hyun;Sohn, Kwgng-Hyun
    • Radiation Oncology Journal
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    • v.9 no.2
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    • pp.215-219
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    • 1991
  • To evaluate the effect of MVP chemotherapy and hyperfractionated radiotherapy in Stage III unresectable non small cell lung cancer (NSCLC), authors have conducted a prospective randomized study since January 1991, Stage IIIa or IIIb unresectable NSCLC patients were treated with hyperfractionated radiotherapy (120 cGy/fx BID) up to 6500 cGy following 3 cycles of induction MVP (Mitomycin C 6 mg/$m^2$, Vinblastine 6 mg/$m^2$, Cisplatin 60 mg/$m^2$) and randomized for either observation or 3 cycles of maintenance MVP chemotherapy. Until August 1991, 18 patients were registered to this study. 4 cases were stage IIIa and 14 were stage IIIb. Among 18 cases 2 were lost after 2 cycles of chemotherapy, and 46 were analyzed for this preliminary report. The response rate of induction chemotherapy was $62.5\%$ : partial response, $50\%$ and minimal response, $12.5\%$. Residual tumor of the one partial responder was completely disappeared after radiotherapy. Among 6 cases who were progressed during induction chemotherapy, 4 of them were also progressed after radiotherapy. All patients were tolerated BID radiotherapy without definite increase of acute complications, compared with conventional radiotherapy group. But at the time of this report, one patient expired in two month after the completion of the radiotherapy because of treatment related complication. Although the longer follow up is needed, authors are encouraged with higher response rate and acceptable toxicity of this treatment. Authors believe that this study is worthwhile to continue.

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Study to the randomized response model (확률응답모형에 관한 연구)

  • 이영진
    • The Korean Journal of Applied Statistics
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    • v.4 no.2
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    • pp.179-193
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    • 1991
  • In this paper, we introduce various methods of PR techniques initiated by S. Warner in 1960's and examine the maximum likelihood estimator for them. One of the main subjects of this paper is to represent Warner model, Unrelated Question Model, and Multi-Proportion Model in linear model. The other subject is to study the inference of PR model by using the Bayesian Approach.

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New Unrelated Question Randomized Response Model (새로운 무관확률화응답모형)

  • 이기성;홍기학
    • The Korean Journal of Applied Statistics
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    • v.12 no.1
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    • pp.143-152
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    • 1999
  • 본 논문에서는 응답자가 민감한 속성을 가지고 있지 않으면 직접 "예"라고 응답하고, 민감한 속성을 가지고 있으면 Greenberg et al.(1969)의 무관질문모형의 확률장치를 이용하여 선택된 질문에 응답을 하는 새로운 무관확률화응답모형을 제안하였다. 그리고, 제안한 모형이 Mangat(1994)의 관련질문모형보다 효율적인 되는 조건을 제시하였고, 수치적으로 효율성을 비교하였다. 또한, Leysieffer와 Warner(1976)의 위험함수와 Flinger et al.(1977)의 사생활 보호 측도를 이용하여 제안한 모형이 Mangat의 관련질문모형에 비하여 개인의 사생활을 보호해 주는 측면에서 더 효율적임을 보였다.효율적임을 보였다.

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Effects of Relaxing Music on Stress Response of Patients with Acute Myocardial Infarction (이완음악이 급성 심근경색증 환자의 스트레스 반응에 미치는 효과)

  • 이혜란
    • Journal of Korean Academy of Nursing
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    • v.33 no.6
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    • pp.693-704
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    • 2003
  • Purpose: The purpose of this study was to determine whether a relaxing music was effective in reducing stress response of patients admitted to a coronary care unit with the diagnosis of acute myocardial infarction. Method: The research design was the chosen convenience sample of a randomized control group pre-posttest quasi-experimental design. Forty patients, 20 for an experimental group and another 20 for control group. The study was to provide the patients three different kinds of relaxing music. The experimental group listened to relaxing music for a 20-minute one time a day for 3days. The control group was just provided with a 20-minute period of rest. Test for hypothesis was done by repeated measured ANOV A. Result: The experimental group which received relaxing music showed a significantly lower level of electrodermal response, myocardial oxygen consumption and respiration rate, and a higher level of peripheral skin temperature than the control group. The experimental group which received relaxing music showed a significant reduction in state anxiety than the control group. Conclusion: The results showed that relaxing music is an effective nursing intervention for reducing physiologic and psychologic stress response of the patients with acute myocardial infarction in a critical intensive care unit.

Ifosfamide-containing Regimens for Treating Patients with Osteosarcomas

  • Li, Yan-Yan;Jiang, Xiao-Ming;Dong, Yi-Guo;Xu, Gang;Ma, Yu-Bo
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.22
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    • pp.9763-9766
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    • 2014
  • Background: This systemic analysis was conducted to evaluate the efficacy and safety of an ifosfamide-containing regimen in treating patients with osteosarcoma. Methods: Clinical studies evaluating the efficacy and safety of Ifosfamide-containing regimen on response and safety for patients with osteosarcoma were identified by using a predefined search strategy. Pooled response rate (RR) of treatment were calculated. Results: When ifosfamide-containing regimens were evaluated, 4 clinical studies which including 134 patients with osteosarcoma were considered eligible for inclusion. Systemic analysis suggested that, in all patients, pooled RR was 44.8% (60/134) in ifosfamide-containing regimens. Major adverse effects were neutropenia, leukopenia, and fatigue inIfosfamide-containing regimens; No treatment related death occurred in cantharidin combined regimens. Conclusion: This systemic analysis suggests that ifosfamide-containing regimens are associated with good response rate and acceptable toxicity in treating patients with osteosarcoma, but this result should be confirmed by randomized clinical trials.

Cantharidin Combined with Chemotherapy for Chinese Patients with Metastatic Colorectal Cancer

  • Han, Li;Sun, Yi-Jie;Pan, Yong-Fu;Ding, Hao;Chen, Xi;Zhang, Xu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.24
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    • pp.10977-10979
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    • 2015
  • Background: This systematic analysis was conducted to evaluate the efficacy and safety of cantharidin combined with chemotherapy in treating Chinese patients with metastatic colorectal cancer. Methods: Clinical studies evaluating the efficacy and safety of cantharidin combined with chemotherapy on response and safety for Chinese patients with colorectal cancer were identified using a predefined search strategy. Pooled response rate (RR) of treatment were calculated.Results: When cantharidin combined with chemotherapy, 4 clinical studies which included 155 patients with advanced colorectal cancer were considered eligible for inclusion. The systematic analysis suggested that, in all patients, pooled RR was 46.5% (72/155) in cantharidin combined regimens. Major adverse effects were neutropenia, leukopenia, fatigue, and anemia with cantharidin combined treatment; no treatment related deaths occurred. Conclusion: This systematic analysis suggests that cantharidin combined regimens are associated with high response rate and accepted toxicity in treating Chinese patients with metastatic colorectal cancer suggesting that randomized clinical trials are now warranted.

A Stratified Randomized Response Technique (층화 확률화 응답 기법)

  • Ki Hak Hong;Jun Keun Yum;Hwa Young Lee
    • The Korean Journal of Applied Statistics
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    • v.7 no.1
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    • pp.141-147
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    • 1994
  • In the present paper an attempt has been made to develop a stratified ramdomized response technique when the respondents are selected using simple random sampling without replacement (SRSWOR) as well as simple random sampling with replacement (SRSWR). The conditions under which the proposed technique will be more efficient than the corresponding Warner's technique have been obtained.

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Dietary Zinc Effects on Growth Performance and Immune Response of Endotoxemic Growing Pigs

  • Roberts, E.S.;van Heugten, E.;Lloyd, K.;Almond, G.W.;Spears, J.W.
    • Asian-Australasian Journal of Animal Sciences
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    • v.15 no.10
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    • pp.1496-1501
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    • 2002
  • A $2{\times}3$ factorial arrangement of treatments was used in a completely randomized design to determine the effects of dietary Zn on performance and immune response of acutely endotoxemic growing pigs (n=96, mean BW=24.9 kg). Factors included 1) intramuscular injection of $10{\mu}g/kg$ BW of Escherichia coli lipopolysaccharide (LPS) or control and 2) supplemental Zn at 10, 50, or 150 ppm. Diets were fed beginning after weaning (initial body weight=7.6 kg) in the nursery and continued for 16 d into the grower phase. The basal corn-soybean meal grower diet contained 1% lysine and 34.3 ppm Zn. Pigs were acclimated for 12 d in the growerfinishing facility before LPS treatment on d 13. Gain, feed intake, and feed efficiency were unaffected by dietary Zn. Feed intake decreased (p<0.10) and gain/feed was greater (p<0.10) from d 13 to d 16 for pigs injected with LPS. Serum Zn and alkaline phosphatase activity increased (p<0.05) with increasing Zn levels. The febrile response to LPS peaked at 6 h post exposure and pigs were afebrile within 12 h. Rectal temperature was greater (p<0.05) in pigs receiving 50 and 150 ppm Zn than in pigs supplemented with 10 ppm Zn. In vivo cellular immune response, measured on d 13 by skin thickness response to phytohemagglutinin (PHA), was greater after 6 h (p<0.05) in pigs fed 10 ppm Zn and exposed to LPS compared to all other treatments, but was not affected at 12, 24 or 48 h. Zinc did not affect mitogen induced lymphocyte proliferation. Zinc supplemented at 50 or 150 ppm resulted in an enhanced febrile response in pigs subjected to iatrogenic endotoxemia, but did not affect pig performance or immune response measurements.

Factors Associated with Indacaterol Response in Tuberculosis-Destroyed Lung with Airflow Limitation

  • Kim, Tae Hoon;Rhee, Chin Kook;Oh, Yeon-Mok
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.1
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    • pp.35-41
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    • 2019
  • Background: Pulmonary tuberculosis can result in anatomical sequelae, and cause airflow limitation. However, there are no treatment guidelines for patients with a tuberculosis-destroyed lung. Recently, indacaterol effectiveness in chronic obstructive pulmonary disease (COPD) patients with Tuberculosis history (INFINITY) study revealed indacaterol provided bronchodilation and symptom improvement in COPD patients with a tuberculosis-destroyed lung. Methods: We conducted a post-hoc subgroup analysis of the randomized controlled trial, the INFINITY study, to determine factors associated with indacaterol response in a tuberculosis-destroyed lung with airflow limitation. Data from 68 patients treated with inhaled indacaterol, were extracted and analyzed. Factors associated with the response of forced expiratory volume in one second ($FEV_1$) to indacaterol treatment, were determined using linear regression analysis. Results: Of 62 patients included, 68% were male, and 52% had history of cigarette smoking. Patients revealed mean $FEV_1$ of 50.5% of predicted value with mean improvement of 81.3 mL in $FEV_1$ after indacaterol treatment for 8 weeks. Linear regression analysis revealed factors associated with response of $FEV_1$ to indacaterol included a short duration of smoking history, and high short-acting bronchodilator response. When patients with history of smoking were excluded, factors associated with response of $FEV_1$ to indacaterol included high short-acting bronchodilator response, and poor health-related quality of life score as measured by St. George's Respiratory Questionnaire for COPD. Conclusion: In a tuberculosis-destroyed lung with airflow limitation, short-acting bronchodilator response and smoking history can play a critical role in predicting outcomes of indacaterol treatment.