Issues in applying recent CPMP ‘Points to Consider’ and FDA guidance documents with biostatistical implications

The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd.     

Implementing a college mental health program – an overview of the first twelve months

Objective: To evaluate the demographics and clinical utilization patterns among college students during the initial 12 months of a novel, multi-disciplinary, collaborative, college mental health program (CMHP). Participants: Undergraduate and graduate students receiving treatment at the CMHP from Jan-Dec 2015. Methods: De-identified data was obtained via electronic health records for all students receiving care through the CMHP. Results: 1.2 FTE clinical providers treated 278 undergraduate and graduate students during the year (65.1% < age 26, 53.6% female, 49.6% caucasian). There were 1822 CMHP outpatient visits, 318 other medical visits and 103 total emergency room (ER)/inpatient visits. Ten students were identified as high utilizers of ER/inpatient services, while charges to the CMHP totaled $470,157 and total charges to the Health System were $2,378,315. Conclusions: Students with complex psychiatric/medical co-morbidities received cost effective, convenient and integrative treatment. Over time, we hope to intervene earlier and decrease ER/inpatient visits.     

Gerontological Social Work Student-Delivered Respite: A Community-University Partnership Pilot Program

ABSTRACT

This study describes a community-university partnership to support a gerontological social work student-delivered respite program, the Houseguest Program (Houseguest). Houseguest was designed using a community-engaged scholarship model of integrating research, teaching, and service. Houseguest was piloted with a small group of community-dwelling, coresiding dementia caregivers and care recipients. We examined caregivers’ experiences with student-delivered respite using qualitative data analysis. Thematic analysis produced 8 themes: (a) respite from full time caregiving role, (b) information on caregiving strategies, (c) no-cost supportive services, (d) opportunity for care recipients to socialize, (e) tailored activities for care recipients, (f) rapport-building between students and family dyad, (g) reciprocity between students and family dyad, and (h) program continuation. We conclude with a proposed community-engaged scholarship model for dementia caregiving. Through a community-university partnership, Houseguest reduced the impact of caregiver burden and created an opportunity for students to serve families affected by dementia through respite and tailored activities.     

Speaking Out: Youth Led Research as a Methodology Used with Homeless Youth

Participatory action research is well documented with marginalized groups, but less is known about participatory action research with homeless youth. The use of youth led research as a methodology was examined among a population of homeless youth. Peer researchers (n = 10) reported on their experience utilizing youth led research methodology. Results indicate that youth led research is a promising methodology for use among homeless youth. Participants reported that the approach positively impacted the quality and quantity of data that could be collected from participants. Further, peer researchers reported individual benefits of feeling that participating in the project mattered, that people listened to them and that they had a voice.     

Global Governance in the Making: Prospects for a New World Order in Tackling Economic Injustice

One of the proposed solutions to economic justice is the concept of global governance, a world order wherein nations, formerly self-seeking and sovereign, would unselfishly cooperate towards solving problems with worldwide repercussions. Is this a utopian ideal or is this an immediate reality? To what extent is this possible, much less achievable?     

Identifying meaning and perceived level of satisfaction within the context of work

OBJECTIVE: The primary objectives of this study were to identify sources of meaning for individuals within the context of a work environment, and to compare varied sources of meaning for individuals with high and low work satisfaction levels. METHOD: Participants were chosen based on satisfaction levels in employment, full-time employment status within an organization for at least one year, and diversity in the work setting. Data were gathered through a series of interviews and observations of the participants' workplaces. A comparative analysis of transcribed interviews was conducted by the researchers and with an expert occupational therapy faculty panel. From these analyses, the researchers developed work narratives for a mechanical engineer, a high school teacher, an employee of mechanical services, and a career service counselor. RESULTS: Emerging themes from the work narratives indicated that the various meanings employees found in work had an effect on their perceived levels of job satisfaction. Participants conveyed that organization identification, financial benefits, independent decision-making, reciprocal respect, opportunities for creativity, and maintaining significant relationships outside of work enhanced meaning and satisfaction. CONCLUSIONS: The worker role is a significant source of an individual's identity, meaning, and satisfaction in life. Professionals in various fields can work with employers to develop meaningful work environments for increased job satisfaction, greater motivation for work, increased productivity, and decreased employee turnover.     

Being Judged,Being Assessed: Young People’s Perspective of Assessment in Youth Justice and Education

Research from the Economic and Social Research Council programme on Pathways Into and Out of Crime prioritised young people’s ‘voices’ in exploring experiences of crime and a range of intervention services. Drawing on data from interviews with 110 young people, this paper explores their perspectives of professional assessment. Embedded within neo‐liberal youth welfare policies are a number of contradictions. Policies encourage ‘individualisation’, ‘responsiblisation’ and ‘self‐realisation’ while also needing to maintain control and regulation of ‘risky’ populations. This paper explores the implication of these contradictions through examining the experiences of young people being assessed in youth justice and education. The impact on their identities as neo‐liberal citizens is discussed in the conclusion.     

当代中国的音乐及社会差序——京剧票友会与摇滚乐队“派对”比较研究

本文主要探讨当代中国的两种音乐活动形式——京剧票友会以及摇滚乐队派对。这两种音乐形式虽然在风格上截然不同,但是两种社团在结构上却存在着一定的相似性。这两种活动形式基本上都具有我们所称之为＂为位＂（positioning）的行为,参与者由此在音乐活动中找到他们各自的位置。而且,两种活动形式都涉及到＂外来者的融入＂（outsider integration）,即允许陌生人的参与并在活动中找到他们的位置。     

The problem of social generations: a critique of the new emerging orthodoxy in youth studies

Over the previous seven years the application of a social generation paradigm or ‘theory’ has gained increasing currency as a method in analysing young people's relationship with the life course. Whilst not a new concept or approach its resurgence and reconfiguration to ‘new’ times has seen some writers positioning it as a ‘new orthodoxy’ or ‘consensus’ within youth studies. In this it is seen as providing a conceptual framework that better helps us understand the complexity of circumstances and conditions that shape youth identities in late modern society. In this paper we examine and explore the underlying assumptions and claims that are made by those advocating the social generational paradigm, raising questions and seeking further clarification on a number of key themes. We accept youth studies needs to move beyond ‘old models’ that define and understand social context as a simply a tension between ‘structure or/and agency’ or as a ‘flavour’ to social action. To conclude therefore we propose the need to have an approach that is ecological and both accepts ‘social change’ and ‘continuity’ as critical parts of the life course, one that recognises the nature and influence of power and social reproduction, especially for different social classes, in shaping the experience of being young.