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.     

What shapes plant and animal diversity on urban golf courses?

Recent concern over increasing loss of biodiversity has prompted considerable interest in the role of urban green spaces as reservoirs of local biodiversity. This study assessed the diversity of three indicator taxa - plants, ants and birds - on golf courses spanning a wide range of environmental variation in terms of climate, elevation, course age, size and connectivity to native woodland. Species richness and community composition was further compared between contrasting on-course habitat types that reflect different management intensities. We identified a set of taxon-specific environmental correlates indicating an intricate interplay of landscape- and local-scale variables that affect local species diversity. Our results show that floristic diversity is positively associated with the amount of rainfall, whereas ant and bird diversity are related to local-scale factors, particularly the number of trees and the size of water features on a site. The amount of on-course native habitat was a strong predictor of plant and ant diversity and was also associated with the number of unique species at the site level; this reinforces the value of remnant habitat patches as local biodiversity reservoirs that represent mini hot-spots in an otherwise species-poor urban landscape. Community composition for all three taxa differed markedly between non-playing and playing areas, with boundary and remnant habitats generally having more diverse, species-rich communities. Our results suggest that local floral and faunal biodiversity on urban golf courses can be enhanced by creating woody non-playing areas and, especially, by preserving, restoring or expanding remnant habitats.     

Teaching Note—Social Work Serial: Using Video-Recorded Simulated Client Sessions to Teach Social Work Practice

Simulation, the use of trained actors as simulated clients, has gained empirical support as an effective teaching and assessment method in social work education. The associated costs involving the use of live simulation, however, often pose a barrier and prevent less resourced schools from implementing this pedagogical approach in the classroom. Social Work Serial is a pedagogical project that used video-recorded simulated client sessions as an alternative to live simulation. In this teaching note, we will describe step-by-step production and implementation processes involving the project and discuss the implications of video-based simulation for social work education.     

Effects of Maternal Responsiveness on Infant Responsiveness and Behavior in the Still‐Face Task

The effects of maternal responsiveness on infant responsiveness and behavior in the Still‐Face Task were longitudinally examined through infants' first 3 months. Maternal vocal responsiveness and infant vocal and smiling responsiveness significantly increased when infants were 2 months of age. Mothers showed continuity of individual differences in vocal responsiveness from the infants' newborn period. Maternal responsiveness predicted infant responsiveness within and across sessions. Compared with infants with low‐responsive mothers, infants with high‐responsive mothers were more attentive and affectively engaged during the Still‐Face Task from 1 month of age. Infants with high‐responsive mothers discriminated between the task phases with their smiling at 1 month, a month before infants with low‐responsive mothers did so. Infants in both groups discriminated between the phases with their attention and nondistress vocalizations throughout their first 3 months. Results suggest that maternal responsiveness influences infant responsiveness and facilitates infants' engagement and expectations for social interaction.     

AN EMPIRICAL ASSESSMENT OF COMPUTER-ASSISTED DECISION ANALYSIS*

Decision analysis tools often are used in semistructured and ill-structured situations. While some researchers have argued that computerized decision analysis programs may improve decision quality in such situations, research support for this assertion is weak. In this laboratory study, business students used a computerized decision-analysis program with short strategic-management cases to prepare decision reports. Independent raters' perceptions of aided and unaided decision performance were contrasted, attitudes of students toward the program were assessed, individual differences were correlated with attitudes, and the program's impact on students' perceptions of their decision processes and performance was examined. Student attitudes toward the computerized aid were favorable, and individual differences in reactions generally were as predicted. However, the program did not improve the independent ratings of students' decision reports and recommendations. These findings suggest that computerized decision aids should be adopted cautiously. If such aids result in positive user affect and heightened decision confidence without corresponding improvements in decision quality, they may be dysfunctional. Rigorous research methodologies which incorporate independent evaluations of analyses and decisions are recommended for use in future research on computerized decision-analysis programs.     

‘I shouldn’t be living there because I am a sponger’: negotiating everyday geographies by people with learning disabilities

Learning disability policy has for some time been framed by the goal of inclusion which purports to enable people with learning disabilities to lead a ‘life like any other’ person. This article examines the extent to which this is the case in England, by tracing the lived experiences of people with learning disabilities within their communities. The article draws on two interlinked qualitative studies involving interviews that examined their local place-based experiences of inclusion and exclusion. The findings reveal ‘moments of inclusion’ and opportunities for social encounter from peer support, but these were situated amidst wider experiences of exclusion and harassment.     

Self,Career and Nationhood: The contrasting aspirations of British and French elite graduates

There is increasing interest in the emergence of a ‘global middle class’ in which high achieving young graduates increasingly look to develop careers that transcend national boundaries. This paper explores this issue through comparing and contrasting the aspirations and orientations of two ‘elite’ cohorts of graduates. Interviews with students at the University of Oxford, England, and Sciences‐Po, France, reveal very different ambitions and allegiances. Our Oxford respondents portray their futures as projects of self‐fulfilment as they build portfolio careers by moving from job to job and from country to country with limited social allegiances – epitomizing the nomadic worker of the transnational elite. Our Parisian respondents, on the other hand, display strong allegiances to the nation, state and civic duty. Their projects of the self involve reconciling their personal aspirations with strong allegiances to France. The paper concludes by discussing the significance of these differences. It argues that the enduring role of education in the formation of national identities should not be overlooked and that more detailed research is needed on the contextual specifity of transnationalism and the (re)production of elites.     

Risk of Disclosure, Perceptions of Risk, and Concerns about Privacy and Confidentiality as Factors in Survey Participation

This article reports on a web-based vignette experiment investigating how likely subjects would be to participate in surveys varying in topic sensitivity and risk of disclosure. A total of 3,672 participants each responded to a series of eight vignettes, along with a variety of background questions, concerns about confidentiality, trust in various institutions, and the like.Vignettes were randomly assigned to respondents, such that each respondent was exposed to four levels of disclosure risk for each level of topic sensitivity (high versus low). Half the sample was assigned to receive a confidentiality statement for all eight vignettes, while the other half received no mention of confidentiality in the vignettes. The order of presentation of vignettes was randomized for each respondent.Respondents were also asked for their subjective perceptions of risk, harm, and social as well as personal benefits for one of the eight vignettes. Adding these questions permits us to examine how objective risk information presented by the researcher relates to the subjective perception of risk by the participant, and to assess the importance of both for their willingness to participate in the surveys described.Under conditions resembling those of real surveys, objective risk information does not affect willingness to participate. On the other hand, topic sensitivity does have such effects, as do general attitudes toward privacy and survey organizations as well as subjective perceptions of risk, harm, and benefits. We discuss the limitations and implications of these findings.     

基于BP人工神经网络的磨料水射流切割深度模型

在已知的磨料水射流切割混凝土实验数据的基础上,应用BP人工神经网络理论,并且借助MATLAB神经网络工具箱,建立磨料水射流切割深度模型.模型中包括的射流参数有射流压力、靶距、磨料粒径、磨料流量、磨料喷嘴直径、磨料喷嘴长度及横移速度.通过模型预测结果与实验结果的比较,表明模型具有一定的精度.