The COVID‐19 Pandemic and Families in Japan

This paper, which is authored by members of the Japanese Association of Family Therapy (JAFT), describes the COVID‐19 pandemic in Japan from a family systems perspective. The authors are active members of JAFT and include current and past presidents and officers. We describe the course of the pandemic and the ways in which government policies to mitigate the pandemic have affected Japanese families. Challenges that affect Japanese families include the inability to participate in family and social rituals, prescribed gender roles that specifically affect women, high suicide rates, and prejudice against those who are at risk of spreading the infection. The need to shelter in place has also forced family homes to function as a workplace for parents, classrooms for children, and day care services for frail elders, which has resulted in psychological distress among individuals and conflicts among families. We discuss ways that therapists have worked with Japanese families using online therapy.     

The plan of enrichment designs for dealing with high placebo response

To deal with high placebo response in clinical trials for psychiatric and other diseases, different enrichment designs, such as the sequential parallel design, two‐way enriched design, and sequential enriched design, have been proposed and implemented recently. Depending on the historical trial information and the trial sponsors' resources, detailed design elements are needed for determining which design to adopt. To assist in making more suitable decisions, we perform evaluations for selecting required design elements in terms of power optimization and sample size planning. We also discuss the implementation of the interim analysis related to its applicability.     

Global benefit-risk assessment in designing clinical trials and some statistical considerations of the method

When characterizing a therapy, the efficacy and the safety are two major aspects under consideration. In prescribing a therapy to a patient, a clinician puts the two aspects together and makes a decision based on a consolidated thought process. The global benefit-risk (GBR) measures proposed by Chuang-Stein et al. (Stat. Med. 1991; 10:1349-1359) are useful in facilitating the thinking, and creating the framework for making statistical comparisons based on benefit-risk point of view. This article describes how a GBR linear score was defined and used as the primary outcome measure in a clinical trial design. The robustness of the definitions of 'benefit' and 'risk' are evaluated using different criteria. The sensitivity of the pre-specified weights is also analyzed using alternative weights; one of those was determined by the relative to an identified distribution integral transformation approach (Biometrics 1958; 14:18-38). Statistical considerations are illustrated using pooled data from clinical trials studying antidepressant. The pros and cons for using GBR assessments in the setting of clinical trials are discussed.     

Prediction in Multilevel Logistic Regression

The purpose of this article is to present a new method to predict the response variable of an observation in a new cluster for a multilevel logistic regression. The central idea is based on the empirical best estimator for the random effect. Two estimation methods for multilevel model are compared: penalized quasi-likelihood and Gauss–Hermite quadrature. The performance measures for the prediction of the probability for a new cluster observation of the multilevel logistic model in comparison with the usual logistic model are examined through simulations and an application.     

Asylum Provision: A Review of Economic Theories

In recent years, economic theories have been used to examine asylum provision by non‐persecutor countries. Unfortunately, the nature of the analyses makes the results inaccessible to many who are interested in understanding the topic from multidisciplinary perspectives but are unfamiliar with mathematical methods in economics. We communicate the findings of those analyses in a non‐mathematical fashion, thereby contributing to a facilitation of interdisciplinary research on asylum policy.     

智慧财产法政策学初探

智慧财产法律制度的设计应当遵从市场指向型、功能性、自由统御型智慧财产法的思考方法,在通过分担市场、立法、行政、司法的作用,以实现有效率的制度的同时,也应当确保自由的追求、面向承虻墓瓜?这两者作为阐述智慧财产制度设计方法的智慧财产法政策学的纵坐标和横坐标,共同发挥作用.在政策形成过程中,易于组织化的大企业的利益容易被反映,不易组织化的私人的利益难以被反映,由于这种结构性不均衡的作用,智慧财产权往往被过度强化.因此,为了尽可能消除不均衡,一边探索统领政策形成过程的构造,同时为了确保自由,通过运用司法的作用,保障程序的正统性.从效率性的观点来看,尽可能释明所希望的制度(或者不希望的制度),同时将应该确保自由的领域明确化,在呈示这种归结主义的理论的基础上,应该减少灰色的领域,缩小由程序决定的裁量的范围.     

Relation Between Benchmark Dose and No-Observed-Adverse-Effect Level in Clinical Research: Effects of Daily Alcohol Intake on Blood Pressure in Japanese Salesmen

The benchmark dose (BMD) is defined as the dose that corresponds to a specific change in an adverse response compared to the response in unexposed subjects, and the lower 95% confidence limit is termed the benchmark dose level (BMDL). In this study, the threshold of daily ethanol intake affecting blood pressure was calculated by both the BMD approach and multiple logistic regression analysis to clarify the relation between the BMDL and no-observed-adverse-effect level (NOAEL). Systolic and diastolic blood pressures (SBP and DBP) and daily ethanol intake were explored in 1,100 Japanese salesmen. The SBP and DBP were positively related to daily ethanol intake (p < 0.001) when adjusting for possible confounders such as age, body mass index, and smoking status. The adjusted risk for hypertension (SBP >or= 140 mmHg or DBP >or= 90 mmHg) increased significantly when daily ethanol intake exceeded 60 g/day, and the categorical dose of interest was 60.1-90 g/day. The BMDL and BMD of ethanol intake for increased SBP and DBP were estimated to be approximately 60 and 75 g/day, respectively. These findings suggest that the BMDL and BMD correspond to the NOAEL and lowest-observed-adverse-effect level, respectively, if the sample number of clinical data is large enough to confirm the dose-response association.