Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials

When a candidate predictive marker is available, but evidence on its predictive ability is not sufficiently reliable, all‐comers trials with marker stratification are frequently conducted. We propose a framework for planning and evaluating prospective testing strategies in confirmatory, phase III marker‐stratified clinical trials based on a natural assumption on heterogeneity of treatment effects across marker‐defined subpopulations, where weak rather than strong control is permitted for multiple population tests. For phase III marker‐stratified trials, it is expected that treatment efficacy is established in a particular patient population, possibly in a marker‐defined subpopulation, and that the marker accuracy is assessed when the marker is used to restrict the indication or labelling of the treatment to a marker‐based subpopulation, ie, assessment of the clinical validity of the marker. In this paper, we develop statistical testing strategies based on criteria that are explicitly designated to the marker assessment, including those examining treatment effects in marker‐negative patients. As existing and developed statistical testing strategies can assert treatment efficacy for either the overall patient population or the marker‐positive subpopulation, we also develop criteria for evaluating the operating characteristics of the statistical testing strategies based on the probabilities of asserting treatment efficacy across marker subpopulations. Numerical evaluations to compare the statistical testing strategies based on the developed criteria are provided.     

Professional blinders? The novel as an eye-opener in organizational analysis

ABSTRACT

Scholarly textbooks often follow a logic where suitable empirical cases are selected to illustrate the theoretical and analytical points that we as scholars want to make. But what would happen if we would do the opposite: build a textbook on a novel written by a novelist for such purpose and let the theories explain the actions and emotions of fictional characters? In this article, we share and reflect upon our experiences of co-authoring a textbook in organization theory together with a professional novelist. We argue that the novel can function as an eye-opener in organizational analysis, forcing us to look beyond more static and rationalistic perspectives on organizations as well as the stereotypes of such. We build and relate our experiences to the growing literature about using fiction in scholarly work and discuss the potential of such genre-bending work when we bring in flesh and blood into the analyses.     

Maternal and paternal reactions to child sadness predict children's psychosocial outcomes: A family‐centered approach

Parents' reactions to children's emotions shape their psychosocial outcomes. Extant research on emotion socialization primarily uses variable‐centered approaches. This study explores family patterns of maternal and paternal responses to children's sadness in relation to psychosocial outcomes in middle childhood. Fifty‐one families with 8‐ to 12‐year‐old children participated. Mothers and fathers reported their reactions to children's sadness and children's social competence and psychological adjustment. Cluster analyses revealed three family patterns: Supportive (high supportive and low non‐supportive reactions from both parents), Not Supportive (low supportive reactions from both parents), and Father Dominant (high paternal supportive and non‐supportive reactions, low maternal supportive and non‐supportive reactions). Supportive families had children with higher social competence and more internalizing symptoms whereas Father Dominant families had children with lower social competence and fewer internalizing symptoms. Not Supportive families had children with average social competence and fewer internalizing symptoms. Findings are discussed in relation to the “divergence model” which proposes that a diverse range of parental responses to children's sadness, rather than a uniformly supportive approach, may facilitate children's psychosocial adjustment.     

Childbearing and Marriage: Investigating the Importance of Context for Meaning-Making of First-Time Marriage

Previous research reveals that the temporal ordering of childbearing and marriage can have an impact on the meaning of first-time marriage. This article aims to obtain a deeper understanding of meaning-making of first-time marriage in relation to childbearing. Narrative interviews with 16 brides and grooms in 8 couples in Sweden were conducted. The material was analyzed in relation to the temporal ordering of childbearing and marriage. The study reveals that the construction of meaning of marriage does not only relate to the temporal context. Social factors such as social class or family formation might also be relevant for how meaning is constructed. This article contributes to a deeper understanding of meaning-making as a relational process constructed within particular contexts.     

Contextual identity experiencing facilitates resilience in Native American academics

This article discusses the socio-cultural dynamics that interact with ethno-racial identity experiencing in a previously under-researched group. A qualitative interdisciplinary study with 40 Native American academics from 28 mainstream universities across the U.S. served as a case example with findings that contrasted with historically influential theoretical frameworks postulating identity confusion and conflicts at the intersection of one’s mainstream education and profession versus one’s ethno-racial community grounding. Instead of feeling pressure to identify with only one worldview, the contextual, dynamic identities associated with the inclusive and flexible self-concept of tribal participants allowed them to in turn take advantage of two divergent cultural meaning systems pertaining to their distinct socio-cultural contexts. These shifts were experienced as not endogenous but rather exogenous variables, which did not cause the historically theorized issues. Participants felt their tribal identities instead facilitated meaningful integration of the existing incongruences, which resulted in unexpectedly resilient subjective experiencing.     

Stigma, HIV/AIDS and prevention of mother-to-child transmission in Zambia

This report evaluates the extent of perceived and enacted HIV/AIDS-related stigma in a rural setting in Zambia. Stigmatisation is abundant, ranging from subtle actions to the most extreme degradation, rejection and abandonment. Women with HIV and pregnant women assumed to be HIV positive are repeatedly subjected to extensive forms of stigma, particularly once they become sick or if their child dies. Despite increasing access to prevention of mother to child transmission initiatives, including anti-retroviral drugs, the perceived disincentives of HIV testing, particularly for women, largely outweigh the potential gains from available treatments. HIV/AIDS related stigma drives the epidemic underground and is one of the main reasons that people do not wish to know their HIV status. Unless efforts to reduce stigma are, as one peer educator put it, “written in large letters in any HIV/AIDS campaign rather than small”, stigma will remain a major barrier to curbing the HIV/AIDS pandemic.     

上证30指数股市盈率实证分析

通过对2000年上证30指数股市盈率水平及其影响因素进行实证分析,可以发现,其中股息支付率、每股收益增长率、行业平均市盈率对股票P/E值起主要的解释作用,而股本规模因素,解释力却有限,除每股收益增长率外,各变量的相关性与理论分析基本一致.     

The African Evaluation Guidelines: 2002. A checklist to assist in planning evaluations, negotiating clear contracts, reviewing progress and ensuring adequate completion of an evaluation

A review of the US ‘program evaluation standards’ (PES), undertaken in a series of workshops and meetings of networks of evaluators in Africa, resulted in modifications to those standards. The result was presented to a plenary session of the Inaugural Conference of the African Evaluation Association in September 1999, attended by over 300 evaluators from 35 countries. The AfrEA Conference decided that a systematic effort should be made to produce a list of African evaluation guidelines, similar to the PES, and that this checklist should be reviewed by national evaluation associations and networks in Africa and field tested in several countries. Ten national and regional networks and associations suggested modifications to the text and endorsed the final version of the guidelines.     

外向/内向型性格对外语学习的影响

外向/内向型性格与外语学习有相关关系,通过实验证明外向型性格能对外语学习产生积极影响。