Statistical considerations in clinical trial design with event-free survival as the primary efficacy endpoint

In late-phase confirmatory clinical trials in the oncology field, time-to-event (TTE) endpoints are commonly used as primary endpoints for establishing the efficacy of investigational therapies. Among these TTE endpoints, overall survival (OS) is always considered as the gold standard. However, OS data can take years to mature, and its use for measurement of efficacy can be confounded by the use of post-treatment rescue therapies or supportive care. Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits. For evaluating novel treatments for acute myeloid leukemia, EFS has been gradually recognized as a direct measure of clinical benefits. However, the application of an EFS endpoint is still controversial mainly due to the debate surrounding definition of treatment failure (TF) events. In this article, we investigate the EFS endpoint with the most conservative definition for the timing of TF, which is Day 1 since randomization. Specifically, the corresponding non-proportional hazard pattern of the EFS endpoint is investigated with both analytical and numerical approaches.     

Enabling everything: scale,disability and the film The Theory of Everything

This article looks at the representation of scale in the 2014 film The Theory of Everything, identifying moments that relate to three concerns: firstly, how disabled people experience scale issues at an all too practical level in daily life; secondly, how Hawking’s experience of scale at the level of both body and mind is (a)typical of the way it is experienced by disabled people generally; and, thirdly, how a focus on the film can prompt some rethinking of perspectives both within disability studies and within the conceptualisation of scale more broadly.     

Naturalistic social cognition: Intersubjectivity in same-sex dyads

The research paradigm that Ickes and his colleagues (Ickes, Robertson, Tooke, & Teng, 1986; Ickes & Tooke, 1988) have developed for the study of naturalistic social cognition was used to explore the phenomenon ofintersubjectivity as it naturally occurs in the initial, unstructured interactions of same-sex (male-male and female-female) dyads. The results of two studies revealed evidence of greater similarity (i.e., convergence) in the thought-feeling content of the male dyad members than in that of the female dyad members on measures pertaining to the quality of their reported feelings. These findings were consistent with the assumption that, due to a normatively narrower range of affective involvement in the male-male dyads, the male dyad members were more likely than the female dyad members to monitor closely the emotional tone of their interaction. In direct support of this assumption, there was significantly less nonverbal involvement (i.e., gesturing, smiling, gazing, mutual gaze) in the male-male dyads in both studies, along with corresponding differences in the variability of these behaviors. In addition, the results of both studies revealed serendipitous evidence of greater similarity in the thought-feeling content of the female, than of the male, dyad members on measures pertaining to the degree of metaperspective taking and to thoughts and feelings about other people. The discussion emphasized the need for theorists and researchers in cognitive social psychology to address those genuinelysocial-cognitive (i.e., intersubjective) phenomena that have traditionally been ignored.The authors would like to express their appreciation to Kristine Arnold, Ray Bristow, Robin Klemick, Laurie Luce, Julie Williams, and Mari Wilson for their assistance in coding the data for the studies reported here.     

NISO Webinar: The Future of Integrated Library Systems: Part 1: RDA & Cataloging

Abstract

This column's offerings cover late spring through summer to fall of 2011: NISO Webinar: The Future of Integrated Library Systems: Part 1: RDA & Cataloging (May 11); American Library Association Annual Conference (June 23–28); Association of College and Research Libraries New England Serials and Electronic Resources Interest Group Summer Program: Current Trends in E-Journals (August 18); Kentucky Library Association/Kentucky School Media Association Joint Conference (September 28–October 1); American Society for Information Science and Technology Annual Meeting (October 9–12); Great Lakes E-Summit Conference (October 10–11); and Potomac Technical Processing Librarians Annual Meeting (October 21).     

NISO Webinar: The Future of Integrated Library Systems: Part 1: RDA & Cataloging

This column's offerings cover late spring through summer to fall of 2011: NISO Webinar: The Future of Integrated Library Systems: Part 1: RDA & Cataloging (May 11); American Library Association Annual Conference (June 23–28); Association of College and Research Libraries New England Serials and Electronic Resources Interest Group Summer Program: Current Trends in E-Journals (August 18); Kentucky Library Association/Kentucky School Media Association Joint Conference (September 28–October 1); American Society for Information Science and Technology Annual Meeting (October 9–12); Great Lakes E-Summit Conference (October 10–11); and Potomac Technical Processing Librarians Annual Meeting (October 21).     

After the Interview

This article is concerned with after the interview, a strip of time (Goffman 1974, p. 10) between the end of the formal interview and the culmination of leave-taking rituals. Although there is a considerable and growing literature on qualitative interviewing (Arksey and Knight 1999; Kvale 1996; Rubin and Rubin 1995; Weiss 1994), and some corridor talk about the meaning of off the record post-interview comments, this topic has received little attention in the published literature (but see DeSantis 1980 and Wenger 2001). And we think it is an important one, since it illuminates the interviewee's interpretation of the interviewer and interview process, and highlights aspects of the meaning of the topic, and of the interviewer, to the respondent (which is, after all, the endpoint of the qualitative interviewing method). Further, the question of what constitutes after the interview throws into relief the question of what is an interview.     

Effectiveness of a screening tool to detect injuries during Army Health Care Specialist training

The purpose of this project was to evaluate the effectiveness of an initial screening and referral process in reducing the impact of musculosketetal injuries among soldiers attending Health Care Specialist training. Musculoskeletal injury among Army Health Care Specialist students have been reported to be approximately 24% for men and 24-30% for women. The highest student visit rate to the troop medical clinic for musculoskeletal injuries, for men and women, occurs during the first week of training. Anecdotal reports indicate that many students arrive for training with existing injuries or symptoms. This project was designed to assess whether formalized early screening, referral, and intervention could 1) identify arriving students who need musculoskeletal injury-related medical attention, 2) reduce the number of students receiving limited duty status during their 10-week training, 3) decrease the total number of limited duty days for students, and 4) decrease the number of students who cannot graduate due to musculoskeletal injury. Students (N=291) from one company were divided into three groups of 97 students. Three methods were used to screen and refer students for medical intervention: 1) traditional (T), 2) by health care providers (HCP), or 3) by Drill Sergeants (DS). Screening by HCP and DSs involved using a new screening tool to identify and consequently refer students with symptoms to a troop medical clinic (TMC) for early evaluation and intervention. Using the screening tool, HCPs identified 92% of students with injuries, while DSs accurately identified 80%. The screening did not reduce the number of students receiving limited duty status, total limited duty days, or the number of students that could not graduate due to musculoskeletal injury ("holdovers") (p>0.05). The screening tool demonstrated good sensitivity and specificity whether conducted by HCPs or DSs. It failed to demonstrate efficacy in reducing the impact of musculoskeletal injuries among Combat Medic soldiers, as measured by limited duty days and holdovers.     

Suicide and suicide risk in lesbian, gay, bisexual, and transgender populations: review and recommendations

Despite strong indications of elevated risk of suicidal behavior in lesbian, gay, bisexual, and transgender people, limited attention has been given to research, interventions or suicide prevention programs targeting these populations. This article is a culmination of a three-year effort by an expert panel to address the need for better understanding of suicidal behavior and suicide risk in sexual minority populations, and stimulate the development of needed prevention strategies, interventions and policy changes. This article summarizes existing research findings, and makes recommendations for addressing knowledge gaps and applying current knowledge to relevant areas of suicide prevention practice.