Japanese journal of biometrics最新文献_第10页

共通オッズ比を用いる Hardy-Weinberg平衡の検証使用共同率比验证Hardy-Weinberg平衡

Japanese journal of biometrics Pub Date : 2006-12-01 DOI: 10.5691/JJB.27.97

哲司大山, 公雄吉村, 堯柳川

引用次数: 0

Sensitivity Analysis of Publication Bias in Meta-analysis : A Bayesian Approach meta分析中发表偏倚的敏感性分析:贝叶斯方法

Japanese journal of biometrics Pub Date : 2006-12-01 DOI: 10.5691/JJB.27.109

Kimihiko Sakamoto, Y. Matsuyama, Y. Ohashi

{"title":"Sensitivity Analysis of Publication Bias in Meta-analysis : A Bayesian Approach","authors":"Kimihiko Sakamoto, Y. Matsuyama, Y. Ohashi","doi":"10.5691/JJB.27.109","DOIUrl":"https://doi.org/10.5691/JJB.27.109","url":null,"abstract":"Due to the selection process in academic publication, all meta-analysis of published literature is more or less affected by the so-called publication bias and tends to overestimate the effect of interest. Statistically, publication bias in meta-analysis is a selection bias which results from a non-random sampling from the population of unpublished studies. Several authors proposed methods of modelling publication bias using a selection model approach, which considers a joint modelling of the weight function representing the publication probability of each study and a regression of the outcome of interest. Copas (1999) showed that in this approach some of the model parameters are not estimable and a sensitivity analysis should be conducted. In implementing the Copas’s sensitivity analysis of publication bias, a practical difficulty arises in determining the range of sensitivity parameters appropriately. We propose in this article a Bayesian hierarchical model which extends Copas’s selectivity model and incorporates the experts’ opinions as a prior distribution of sensitivity parameters. We illustrate this approach with an example of the passive smoking and lung cancer meta-analysis.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133990653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Utility of Generalized Hazards Model Incorporating Cubic B-spline Function into the Baseline Hazard Function 将三次b样条函数纳入基线危害函数的广义危害模型的应用

Japanese journal of biometrics Pub Date : 2006-12-01 DOI: 10.5691/JJB.27.121

Hisao Takeuchi, I. Yoshimura, C. Hamada

{"title":"Utility of Generalized Hazards Model Incorporating Cubic B-spline Function into the Baseline Hazard Function","authors":"Hisao Takeuchi, I. Yoshimura, C. Hamada","doi":"10.5691/JJB.27.121","DOIUrl":"https://doi.org/10.5691/JJB.27.121","url":null,"abstract":"A generalized hazards model incorporating a cubic B-spline function into the baseline hazard function (GHMBS) was proposed as a model for estimating covariate effects in survival data analysis. The GHMBS integrated the three types of hazard models: the proportional hazards model (PHM), accelerated failure time model (AFTM), and accelerated hazards model (AHM), which enabled the likelihood principle for estimation and hypothesis testing to be applied irrespective of submodels (i.e., PHM, AFTM, and AHM). A procedure for adaptively choosing suitable knots from a set of candidate knots was proposed in order to actualize an appropriate baseline hazard function in GHMBS. The characteristic of the proposal was evaluated with bias and mean squared error of the estimation of covariate effects through a Monte-Carlo simulation experiment. A method for identifying a submodel appropriate for the data to be analyzed was also proposed based on GHMBS. The performance of the proposed model selection method was evaluated with the probability of selecting the true model through a Monte-Carlo simulation experiment based on PHM and AFTM. As a result, the proposed method achieved fairly high probabilities of identifying the true model. An application of the proposed method to actual data in a clinical trial provided a reasonable conclusion.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127782643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Power and Sample Size Calculations in Clinical Trials with Multiple Primary Variables 多主要变量临床试验的功效和样本量计算

Japanese journal of biometrics Pub Date : 2006-12-01 DOI: 10.5691/JJB.27.83

T. Sozu, Takeshi Kanou, C. Hamada, I. Yoshimura

引用次数: 23

Comments on “Points to Consider on Adjustment for Baseline Covariates” 对“基线协变量调整应考虑的问题”的意见

Japanese journal of biometrics Pub Date : 2006-09-30 DOI: 10.5691/JJB.27.S8

Atsushi Hagino

{"title":"Comments on “Points to Consider on Adjustment for Baseline Covariates”","authors":"Atsushi Hagino","doi":"10.5691/JJB.27.S8","DOIUrl":"https://doi.org/10.5691/JJB.27.S8","url":null,"abstract":"1. はじめに 2003年 5月に,欧州医薬品庁 EMEAの医薬品委員会 CPMPから “POINTS TO CONSIDER ON ADJUSTMENT FOR BASELINE COVARIATES”(以下,本ガイダンスという)が公表された.これまで既に数種類の Points to Considerが公表されているが,それらは ICH-E9ガイドラインの中で紹介はされているものの十分に議論されていない事項について,留意すべき点を取り上げ議論し,手引きとしたものである.本ガイダンスは,その Points to Considerの 1つであり,ベースライン共変量の調整に焦点をあてたものである. ベースライン共変量には様々な種類がある.年齢や体重のような人口統計学的変数,罹病期間や重症度のような疾患の状況,各疾患領域で広く受け入れられる予後因子,施設や医師といった因子,そして主要変数のベースライン値などがこれにあたり,本稿では統一的に共変量という用語を使用する. 以下,第 2節では本ガイダンスで述べられている内容を紹介し,第 3節では本ガイダンスの記載内容に関する論点の提示並びに意見を示す.最後の第 4節で本稿のまとめを行う.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131807144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 21

2005年計量生物セミナー「臨床評価における統計学上の論点」に参加して 2005年，我参加了计量生物研讨会“临床评估的统计学论点”

Japanese journal of biometrics Pub Date : 2006-09-30 DOI: 10.5691/JJB.27.S3

和彦森

引用次数: 0

Review of "Points to Consider on Multiplicity Issues in Clinical Trials" and Issues to be Discussed 回顾“临床试验中多重性问题的考虑要点”和需要讨论的问题

Japanese journal of biometrics Pub Date : 2006-09-30 DOI: 10.5691/JJB.27.S64

S. Fujikoshi

引用次数: 0

An Allocation Method for Balancing Prognostic Variables Including Continuous Ones among Treatment Groups Using the Kullback-Leibler Information 一种利用Kullback-Leibler信息平衡治疗组间包括连续预后变量的分配方法

Japanese journal of biometrics Pub Date : 2006-06-30 DOI: 10.5691/JJB.27.1

Akira Endo, C. Hamada, I. Yoshimura

{"title":"An Allocation Method for Balancing Prognostic Variables Including Continuous Ones among Treatment Groups Using the Kullback-Leibler Information","authors":"Akira Endo, C. Hamada, I. Yoshimura","doi":"10.5691/JJB.27.1","DOIUrl":"https://doi.org/10.5691/JJB.27.1","url":null,"abstract":"We propose an allocation method for balancing prognostic variables among treatment groups in clinical trials under the condition that some prognostic variables are continuous and others are categorical. In principle, the proposed method utilizes the sum Sr, with respect to groups, of the Kullback-Leibler information (KLI) from the group-pooled distribution of prognostic variables to the group-specific distribution as the criterion for overall balancing, assuming normal and multinomial distributions, respectively. In the realized procedure, the proposed method allocates sequentially enrolled new subjects to a group with probability Pa so as to achieve the minimum of Sr under the condition that the maximum difference of the number of subjects among groups is in the prespecified allowable range DN . Monte-Carlo simulation studies were conducted in order to compare the performance of the proposed method with the Pocock-Simon method which was the most popular method. The homogeneity test of mean and variance among groups for evaluating the achieved balance showed greater P values in the proposed method than those in the Pocock-Simon method. The parameter estimates of treatment effect adjusted for prognostic variables were also likely to be more stable in the proposed method than in the Pocock-Simon method.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116057799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of Quality of Life Data with Death and Drop-out in Advanced Non-Small-Cell Lung Cancer Patients 晚期非小细胞肺癌患者死亡和退出的生活质量数据分析

Japanese journal of biometrics Pub Date : 2006-06-30 DOI: 10.5691/JJB.27.17

Kazutaka Doi, Y. Matsuyama, Y. Ohashi

{"title":"Analysis of Quality of Life Data with Death and Drop-out in Advanced Non-Small-Cell Lung Cancer Patients","authors":"Kazutaka Doi, Y. Matsuyama, Y. Ohashi","doi":"10.5691/JJB.27.17","DOIUrl":"https://doi.org/10.5691/JJB.27.17","url":null,"abstract":"In measuring quality of life (QOL), outcome-dependent missing values are inevitable because of longitudinal nature of the study. In particular, in clinical trials of advanced-stage disease, it is desirable to distinguish differences between reasons for missing, death and drop-out, because QOL scores for death cases are not really missing data, but are nonexistent and are simply undefined. We focus on estimating the local average treatment effect among survivors. Standard randomized treatment comparisons cannot be performed because the QOL scores are only defined in the non-randomly selected subgroup of survivors. We propose a new estimation method of the survivor average causal effect (SACE) in the presence of both death and dropout. The proposed estimator is a weighted average of the standard estimators for survivors where the weight is the probability that the patient would have survived had he/she received the other treatment. For drop-out cases, the multiple imputation method is applied. Two analysis methods (proposed method and analysis based on only observed survivors) were compared by simulation studies. The proposed estimator had smaller biases with smaller MSEs compared with those of the standard estimator. The proposed method was applied to data from a randomized phase III clinical trial for advanced non-small-cell lung cancer patients.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131409400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

稀な事象の生起確率に関する統計的推測 —Rule of Threeとその周辺— 对罕见事件发生概率的统计推测——Rule of Three及其周边

Japanese journal of biometrics Pub Date : 2005-12-31 DOI: 10.5691/JJB.26.53

学岩崎, 清隆吉田

{"title":"稀な事象の生起確率に関する統計的推測 —Rule of Threeとその周辺—","authors":"学岩崎, 清隆吉田","doi":"10.5691/JJB.26.53","DOIUrl":"https://doi.org/10.5691/JJB.26.53","url":null,"abstract":"For the occurrence of a rare event A such as a severe adverse drug reaction, there exists the “Rule of Three” to remind practitioners that “absence of evidence is not evidence of absence.” The Rule of Three actually says that even if the event A was not observed among n patients it would be quite possible to observe three events among other n patients. The present paper examines this useful rule in detail and also extends it to a testing problem for occurrence probability of A.First, the Rule of Three is extended to the case that the number of the event observed among the first n patients is more than zero. We give rules that when k (> 0) events were observed among n patients, nk events would be possibly observed among other n patients. Next, a testing procedure is introduced to examine whether the occurrence probabilities of A for two populations are the same under the condition that k events were observed among n patients for one population. It will be shown that the relevant probability distribution is a negative binomial, and then critical regions for small k's are given. For a possible application of the procedure, we mention the signal detection for spontaneous reporting system of adverse drug reaction.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2005-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132495543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 4