bluuebunny/crossref_metadata_2025 huggingface dataset:
Humans versus computers
Authors: Giddings Gary
Published: February 2008

Information overload is a very common problem in the business information industry. However, the root of this problem is not too much information; rather it is the fact that humans have limited attention spans to handle this information. Humans possess more processing power than computers but computers score over us in having almost unlimited attention spans. We must allocate our attention span in such a way as to maximize the information we obtain, given the constraint of our mental abilities. We have adopted a number of strategies to cope, like using intelligent search agents or spreading what attention we have thinly across as many information sources as possible (in other words skimming). The financial services industry, however, has adopted a radical approach: cut the human out of key parts of information acquisition and processing and use computers instead. This article argues that this approach could well spread to the wider business information market in the next few years. Far from being a threat, this could prove liberating for information professionals, allowing them to become more expert in specific industry sectors. The new breed of industry information portals, or community sites, will greatly aid in this transition and will build professional skills and efficiency.
From a business and science search firm
Authors: Lesky Cynthia
Published: February 2008

Discusses some principles of managing an information search firm and their similarities to managing corporate libraries. Compares information search firms to other professional service firms. Describes the evolution of one small business and science information search firm. Gives insights into managing customer service and client relationships, quality control and processes, risk taking and professional growth. Touches on David Maister's theory of the quality experience and Michael Gerber's idea of the role of the entrepreneur vs the technician in small start-up businesses.
Harnessing collective expertise
Authors: Blaxland Diane
Published: February 2008

Explains how a leading global law firm manages its market and client research. Outlines the firm's divisions, business activities and client base. Explains in detail how the firm uses business research, covering use of market intelligence on the business issues that an individual client faces, and the gathering of intelligence about the client, to disclose the nature and extent of the firm's ambitions to advise the organization concerned. Discusses the staffing of a law firm's business research capability, pointing out that not only staff expertise but also confidentiality concerns mean that it is not always efficient for lawyers to access internal and external information sources directly. Suggests that defining the minimum business research necessary improves the usefulness of the information delivered and saves the firm time — and that removing the uncertainty about what is required improves job satisfaction as well.
Professionalizing knowledge sharing and communications
Authors: Cullen John
Published: February 2008

Web 2.0 technologies are becoming increasingly ubiquitous among younger generations of IT users and this is creating a new set of expectations about accessing quality information for business, research and academic purposes. The article looks at how this situation has impacted on the expectations of users of library and information services. Although there are solid reasons for standing by professional standards, there is little doubt that the next generation has a greater expectation around being participants in, rather than recipients of, knowledge sharing. How will this impact the status of the professional librarian and information manager, and to what extent should they change with this paradigm shift looming?
Business Information Survey
Authors: Foster Allan
Published: February 2008

Survey of business information services in corporate information services, based on in-depth interviews with leading business information managers. Key findings are:

• Business information budgets have been stable, with at least inflationary increases built in

• Business conditions have been turbulent of late but this has had no real impact on the services to date

• With more information rolled out to the clients' desktops, the services are all working to add value through a variety of approaches, including training, evaluation and analysis, business and client development, and generally undertaking more complex work

• Some pressure on the staffing headcount in the services during the year

• Recruiting suitable information professionals is a difficult process

• Offshoring information and research work has not expanded significantly but more companies are considering this option

• `Techno-centric' knowledge management remains important in some companies, particularly law firms, but is fading as a practice in others

• There is great interest and envisaged potential in social technology and Web 2.0 tools and techniques — but not much serious deployment yet

• Even in mature corporate information environments, marketing business information services is still seen as crucial by 90 per cent of respondents

• Fifty-five percent of the services provide some kind of competitor information function, albeit not at a high level

• A significant majority (75 per cent) of services support compliance functions such as `Know your client' and anti-money laundering checks

• Existing copyright provisions are seen as a barrier to effective information dissemination within companies by 80 per cent of respondents

• LexisNexis takes over at the top of the expenditure league

• The demand for information on Asian business markets is growing

• Almost all services are committed to training users in the discovery and use of digital business information sources

• The organization, management, and sometimes realignment of services is the highest strategic priority.
On the Domestication of American Public Sociology: A Postcolonial Feminist Perspective
Authors: Lal Jayati
Published: February 2008

This article engages with the proposal and call for a renewed engagement with civil society by American academic sociology as put forth by Michael Burawoy's 2004 presidential theme for the American Sociological Association. An examination of the history of US academic interdisciplinary scholarship in area-studies programs suggests that the roots of such a knowledge enterprise in the American university are deeply embedded in state and market interests. It is argued that these imbrications of the university in civil society limit the goal of creating a public sociology that can vitalize civil society and foster counter-hegemonic publics. However, greater attention to this history, and to issues of culture, methodology and interdisciplinarity, may assist in the endeavor to foster a critical (counterhegemonic) public sociology.
Invisible or Pathologized? Racial Statistics and Violence Against Women of Color
Authors: Ferraro Kathleen J.
Published: February 2008

This article applies Tukufu Zuberi's (2001) analysis of racial statistics to the issue of violence against women of color. Data from several national surveys are discussed in terms of the potential for drawing needed attention and resources to women of color and the simultaneous danger of reinforcing stereotypes of pathological communities. I argue for the importance of history and social context as well as qualitative narratives, particularly with regard to rates of violence against African American and American Indian women. Brief narratives from two women are offered to demonstrate the complexities of women's lives that are invisible in statistical data.
The Relationship of Race and Criminal Behavior: Challenging Cultural Explanations for a Structural Problem
Authors: Case Patricia F.
Published: February 2008

Disproportional arrests and conviction rates between blacks and whites in the US criminal justice system is well documented in social research. Many studies have examined the various social explanations for the disproportional arrest rates by race, varying from structural explanations of institutionalized racism and differential poverty outcomes to micro-level analyses of culturally prescribed behaviors. Research that focuses on culturally motivated behaviors may increase the sense of otherness associated with blacks and may minimize the effects of discriminatory criminal justice practices and unequal opportunities. Studies that focus on describing disproportional distributions without also including individual behaviors may also mask successful strategies by blacks avoiding re-arrest as they manage to reintegrate into society. This study analyzes racial differences in recidivism patterns for a cohort of prisoners in the Ohio prison system. Recidivism was tracked for approximately 14 years (through 2006). These ex-prisoners were compared using survival analysis and Cox Regression analysis.
Capital Punishment and Homicide Rates: Sociological Realities and Econometric Distortions
Authors: Goertzel Ted , Goertzel Benjamin
Published: February 2008

Sociological methods have consistently succeeded while econometric methods have failed in research on capital punishment and homicide. But econometricians aggressively promote their findings in public policy venues, while sociologists are less assertive. This is due to cultural differences between the disciplines, and to a philosophy of science that values falsification of hypotheses over progress in answering research questions. This problem has occurred and is likely to reoccur in other policy areas where sociologists are insufficiently assertive in defending their accomplishments.
The War on Drugs and the Gender Gap in Arrests: A Critical Perspective
Authors: Merolla David
Published: February 2008

Many theories of offending have been advanced in an effort to explain the increasing number of women arrested in recent years. In this article, I move away from individual level explanations of offending and attempt to explain this trend with a structural approach. Specifically, I argue that the `war on drugs' has made females more vulnerable to arrest in recent years, regardless of offending behavior. I argue that two arms of the war on drugs, representing direct and ideological aspects of social control, work together to make women more likely to be arrested. This article contributes to the literature in two ways. First, it shows that scholars interested in the gender gap cannot ignore the war on drugs. Second, it shows the utility of a focus on the criminal justice system, and potentially other systems of social control, rather than individual level offending to explain trends in arrests.
Female-Female Non-Partner Assault: A Political-Economic Theory of Street Codes and Female-Gendered Culture in the Contemporary African-American Inner City
Authors: Wallace Don , Hirschinger-Blank Nancy , Grisso Jeane A.
Published: February 2008

In this article we present a theory of the prevalence of female-female non-partner violence in the African-American inner city. We employ `ghetto' (economic) and `internal colony' (political) models to illuminate dimensions of the African-American inner city which we view as proximal determinants of female-female interpersonal violence. These cultural and structural elements include conflict within the separate female-gendered cultural milieu centered in the female-headed household system, and the `rule of force' imposed by agencies of social control as the cultural model for dominance, oppression, and interpersonal violence. Verbatim accounts provided by respondents injured in female-female violent interactions are offered as illustrations of the theory.
Palestinian Children Crafting National Identity
Authors: Habashi Janette
Published: February 2008

This study examines the formulation of national identity in Palestinian children by exploring their understanding of its paradoxes. Twelve Palestinian children were interviewed from cities, villages and refugee camps in the West Bank. The children express the multiple dimensions of national identity in terms of self and other; however these expressions are fragmented in nature. Furthermore, the findings indicate that national identity highlights children as geopolitical agents, rather than separate entities defined by time.
For Their Own Good
Authors: Campbell Alan
Published: February 2008

This article arose from the author's experiences as a researcher exploring children's reactions to their parents' separation. Between 1999 and 2004, the author undertook to find out what a sample of Australian children thought of their abilities to participate in decisions that directly affected them following family breakdown. Before beginning the project, the author was required to obtain ethical approval from the university to which he was attached at that time. He also talked with a number of service providers in Adelaide, where he was based, to request that he receive referrals from them once the research was under way. This article describes the difficulties the author experienced in obtaining ethical approval and subsequently in recruiting children for the research. The article reflects on these difficulties and presents a rationale for considering the participation of children in research about them.
Is Participation Prevention?
Authors: Evans Ruth , Spicer Neil
Published: February 2008

This article explores the relationships between two key concepts that have defined recent social policy initiatives for children in the UK: participation and prevention from social exclusion. Drawing on the Children's Fund initiative as an example, the article traces the diverse and sometimes contradictory discourses of childhood and social inclusion/exclusion in stakeholders' differing rationales for supporting children's participation and prevention. The authors argue that the blurring of the rationales for participation and prevention has implications for the strategies and practices that agencies adopt and raises questions about which groups benefit and whose agendas are served by participation and prevention activities.
`Children Need Their Parents More Than a Pizza in the Fridge!'
Authors: Böök Marja Leena , Perälä-Littunen Satu
Published: February 2008

The aim of this study is to find constructions of parental responsibility by analysing letters sent by readers to a newspaper on the topic of parenting and parental responsibility. The study takes a methodological approach, focusing on the meanings of responsibility and looking at different portrayals of parenthood. Three dimensions of responsibility (beginning responsibility, diminished sense of responsibility and obligating responsibility) emerged from the analysis. These dimensions relate to different meanings attributed to parental responsibility, for instance, `responsibility for making choices'. Parenthood is variously portrayed along the three dimensions. Parental responsibility creates norms for evaluating parents' behaviour. Moreover, responsibility produces and maintains boundaries between adults and children.
Researching Pupil Well-Being in UK Secondary Schools
Authors: Duckett Paul , Sixsmith Judith , Kagan Carolyn
Published: February 2008

This study explores the relationships between a school, its staff and its pupils and the impact of these relationships on school pupils' well-being. The authors adopted a community psychological perspective and applied critical, social constructionist epistemologies and participatory, multi-method research tools. The article discusses the importance of focusing on the complex, multilayered context of people's lives (both participants and researchers) that are impacted by social, economic, cultural and political contexts. Finally, it reflects on the contrast between the messiness of real-world social science research and the often sanitized nature of its reporting.
Household Poverty and Deprivation Among Children
Authors: Grødem Anne Skevik
Published: February 2008

This article focuses on the links between family income, deprivation as reported by parents and deprivation as experienced by children. Data are drawn from a survey of Norwegian families, in which low-income families are oversampled. Three areas of deprivation are explored: housing, consumption and subjective experiences. In each area, indicators of childhood deprivation are developed. It is found that there are clear links, if no absolute overlap, between `adult' and `child' deprivation in each area. When looking at which children experience deprivation, we find that non-western immigrants, children with many siblings and children with non-employed parents are most at risk.
Bullying During the Intermediate School Phase
Authors: Greeff P. , Grobler A.A.
Published: February 2008

Bullying in the intermediate school phase was studied, using the Revised Olweus Bully/Victim Questionnaire (R-OBVQ). The total sample comprised 360 grade 4 to 6 pupils from English-medium, single-sex schools in Bloemfontein, South Africa. To ensure a more homogeneous sample, the grade (grades 4 to 6) and race (black and white) of the participants were controlled. The results yielded a much higher rate of bullying (56.4 percent) than those cited in previous South African as well as international research. In the light of this, more research is necessary to find ways to lessen the deleterious effects of bullying.
Honor as a Moral Category
Authors: Barrett Frank J. , Sarbin Theodore R.
Published: February 2008

In this article we trace the historical transformations of the word `honor' in Western cultures as initially an extrinsic conception equivalent to reputation and social status and later as a moral category independent of external reference. The virtue of `honor' is a window into the dynamics of identity maintenance. By tracing the transformations of `honor' in different cultures through history, we can see how moral categories and notions of self-identity are related and how they evolve. We illustrate modern notions of identity by citing from a study of identity narratives of US Naval officers; we also draw upon the Dreyfus Affair as an illustration of the shift of honor from extrinsic to intrinsic moral marker.
Contemporary Epistemological Research in Education
Authors: Niessen Theo , Abma Tineke , Widdershoven Guy , van der Vleuten Cees , Akkerman Sanne
Published: February 2008

In this article the authors challenge contemporary epistemological research within educational settings. After a reconciliation of the current models which treat epistemological beliefs as static and mechanical, the authors present a teaching experience to illustrate their enactivist view that epistemological beliefs should be conceptualized as fluid and dynamic constructs, emerging in web-like configurations. Answers to epistemological questions unfold within the interstices and mutual interactions between people and their environment. Boundaries between student—teacher, individual—community, cognition—bodily experience are becoming blurred. From this enactivist perspective the researcher's role changes considerably. Instead of determining teachers' personal traits and epistemological make-up, the researcher should sensitize teachers to the subtle ways epistemological beliefs are enmeshed within their day-to-day professional lives, focusing on the complex fabric of the teaching practice.
From Speculation to Epistemological Violence in Psychology
Authors: Teo Thomas
Published: February 2008

Based on historical and theoretical reflections it is argued that speculation cannot be eradicated from psychology and that it is a necessary part of empirical research, specifically when it concerns the interpretation of data. The quality of those interpretative speculations of data is particularly relevant when they concern human groups and differences between them. The term epistemological violence (EV) is introduced in order to identify interpretations that construct the `Other' as problematic or inferior, with implicit or explicit negative consequences for the `Other,' even when empirical results allow for meaningful, equally compelling, alternative interpretations. These interpretations of data are presented as `knowledge' when, in fact, harm is inflicted through them. Examples of EV in the context of `race' are briefly discussed. The concept of EV also demonstrates that the traditional separation of `is' and `ought' is problematic. Reflections on epistemological-ethical issues are provided.
Why P Values Are Not a Useful Measure of Evidence in Statistical Significance Testing
Authors: Hubbard Raymond , Lindsay R. Murray
Published: February 2008

Reporting p values from statistical significance tests is common in psychology's empirical literature. Sir Ronald Fisher saw the p value as playing a useful role in knowledge development by acting as an `objective' measure of inductive evidence against the null hypothesis. We review several reasons why the p value is an unobjective and inadequate measure of evidence when statistically testing hypotheses. A common theme throughout many of these reasons is that p values exaggerate the evidence against H0. This, in turn, calls into question the validity of much published work based on comparatively small, including .05, p values. Indeed, if researchers were fully informed about the limitations of the p value as a measure of evidence, this inferential index could not possibly enjoy its ongoing ubiquity. Replication with extension research focusing on sample statistics, effect sizes, and their confidence intervals is a better vehicle for reliable knowledge development than using p values. Fisher would also have agreed with the need for replication research.
The Rasch Model from the Perspective of the Representational Theory of Measurement
Authors: Kyngdon Andrew
Published: February 2008

Representational measurement theory is the dominant theory of measurement within the philosophy of science; and the area in which the theory of conjoint measurement was developed. For many years it has been argued the Rasch model is conjoint measurement by several psychometricians. This paper critiques this argument from the perspective of representational measurement theory. It concludes that the Rasch model is not conjoint measurement as the model does not demonstrate the existence of a representation theorem between an empirical relational structure and a numerical relational structure. Psychologists seriously interested in investigating traits for quantitative structure should use the theory of conjoint measurement itself rather than the Rasch model. This is not to say, however, that empirical relationships between conjoint measurement and the Rasch model are precluded. The paper concludes by suggesting some relevant research avenues.
The Rasch Model and Conjoint Measurement Theory from the Perspective of Psychometrics
Authors: Borsboom Denny , Scholten Annemarie Zand
Published: February 2008

Kyngdon argues that psychometricians have erroneously claimed the Rasch model to be an instance of representational measurement, because the Rasch model does not map a bona fide empirical relational system (ERS) into a numerical relational system (NRS). While we agree that one does not automatically achieve a conjoint measurement representation upon fitting a Rasch model, we do not agree that the Rasch model could not in principle yield such a representation. In our view, whether this is possible depends on what one is prepared to accept as an empirical relational system. This is a philosophical question that extends beyond the scope of the formal structures advanced in representationalism and psychometrics; a question, moreover, that is not currently settled. We examine some of the ways in which one may react to this question, and conclude that Kyngdon's argument depends on a specific, and perhaps too strong, interpretation of representationalism and psychometric models.
Conjoint Measurement and the Rasch Paradox
Authors: Michell Joel
Published: February 2008

Unlike Andrew Kyngdon, I think the issue he has addressed is most informatively considered outside the confines of the representational theory of measurement. Then it becomes clear that while the theory of conjoint measurement is about situations like that treated by the Rasch model, the former isolates a different feature of those situations to the latter. But, if the relevant attributes are already presumed to be quantitative, the perceived differences are minimized and the Rasch model might seem to be a version of conjoint measurement. It is on this basis that Rasch modellers pursue their paradoxical quest for measurement. However, because the relevant attributes are not actually known to be quantitative, use of the Rasch model to measure psychological attributes remains logically dependent upon the outcome of research involving the theory of conjoint measurement or something very similar.
Conjoint Measurement, Error and the Rasch Model
Authors: Kyngdon Andrew
Published: February 2008

The theory of conjoint measurement was a genuine scientific revolution in measurement theory. For many years psychometricians and applied practitioners alike have contended that the Rasch model is a probabilistic version of this revolutionary theory. I disputed this claim from the perspective of representationalism. Michell's realist appraisal of the issue underscored the conclusions in my paper whilst Borsboom and Zand Scholten maintained that the Rasch model conceptually instantiates the theory of conjoint measurement. Nothing in either response refuted my conclusion. Nevertheless, relationships between the Rasch model and the theory of conjoint measurement remain an open research issue.
`Things That Stay'
Authors: Coleman Rebecca
Published: February 2008

Taking up Grosz's proposal for the `complexities of time and becoming' to be considered seriously, this article explores the status of time and the future within feminist theory through empirical research in which teenage girls describe things `staying'. Focusing on these `things that stay' and drawing on Bergson's concepts of duration and the virtual, the article argues that time is dynamic and heterogeneous; things endure through divergence and transformation. It argues that if the relations of temporality are understood as both continuous and discontinuous, enduring and changing, feminist theory orients to the future in `novel' ways.
Time Perspective and Correlates of Wellbeing
Authors: Drake Lisa , Duncan Elaine , Sutherland Fi , Abernethy Clare , Henry Colette
Published: February 2008

This study investigated correlates of five time perspectives (TPs) and the Balanced Time Perspective (BTP) construct proposed by Zimbardo and colleagues. Two hundred and sixty Scottish participants completed the Zimbardo Time Perspective Inventory (ZTPI: Zimbardo and Boyd, 1999), Subjective Happiness Scale (Lyubomirsky and Lepper, 1999) and Mindful Attention Awareness Scale (Brown and Ryan, 2003). The most prevalent TP profile was moderate to high scores on all five TPs of the ZTPI. BTP participants were significantly happier and more mindful. Happiness and mindfulness were positively correlated but a future TP did not correlate with subjective happiness.
Issues of Social Memory and their Challenges in the Global Age
Authors: Hałas Elżbieta
Published: February 2008

The social experience of time is investigated in connection with the transformation of global power relations expressed symbolically. Collective memory in postmodernity is featured as a temporal distinctiveness of the global age. Consequently, problems of the politics of memory, followed by conflicts of memory come to the fore. Symptomatic for postmodernity in the context of globalization is the phenomenon of reshaping problems of memory into social problems. The global politics of memory and globalizing symbolic conflicts over memory are a new phenomenon. They are exemplified by the problems of memory in post-communist countries, with the focus on the case of Poland.
How Breakfast Happens in the Café
Authors: Laurier Eric
Published: February 2008

In this article I present an ethnographic study of `breakfast in the café', to begin to document the orderly properties of an emergent timespace. In so doing, the aim is to provide a description of the local production of timespace and a consideration of a change to the daily rhythm of city life. Harold Garfinkel and David Sudnow's study of a chemistry lecture is drawn upon as an exemplary study of the collective creation of an event. Attention is drawn to the centrality of sequentiality as part of the orderly properties of occasioned places. As part of examining the sequences I chart the ongoing emergence of features of breakfast time in the café such as `the first customer', `crowded' and `quiet'. In closing the article, I consider how changes in the rhythm of the city are made apprehensible to its residents.
Busyness, Status Distinction and Consumption Strategies of the Income Rich, Time Poor
Authors: Sullivan Oriel
Published: February 2008

This article addresses the dilemma of consumption for those in income-rich, time-poor households in the contemporary affluent economies of the West. Following Linder, two `temporal strategies of consumption' are proposed, reflected in the consumption profiles of high status groups. The first is `voracious' consumption, denoting a fast `pace' and variety of leisure participation. The second is inconspicuous consumption — the purchasing of expensive consumer goods without the time to use them or the primary intent to display them. From a political economic perspective a solution is provided as to how to increase consumer spending among those with high disposable incomes and little leisure time.
Understanding Business Travel Time and Its Place in the Working Day
Authors: Holley David , Jain Juliet , Lyons Glenn
Published: February 2008

This article argues that there is a need to understand business travel time in the context of the wider organization of work time. It considers why travel time use is potentially changing with the use of mobile technologies by the increasing number of individuals engaged in `knowledge work', and examines existing evidence that indicates that travel time use is part of a wider work-related `taskscape'. However, it not only considers material productive output, but suggests that travel time as `time out' from work-related activities also plays a vital role for employees. It also suggests that business travel time use that is not of benefit to the employer may not be at the employer's expense. This is contrasted with the assumptions used in UK transport appraisal. Data gathered from the autumn 2004 wave of the National Rail Passenger Survey (GB) is used to illustrate some key issues concerning productivity and `anti-activity'. A case study of an individual business traveller then points towards the need for a new approach to exploring the role played by travel time in the organization of work practices to be considered.
A Note on Antonio Negri's Break with the Ontology of Time
Authors: Boca Irina
Published: February 2008

The article demonstrates that Antonio Negri's view of time intersects with other post-modern approaches, departing from them in that it reverses space-time, while also keeping it in place. His ontological break with tradition reflects itself in the phenomenology of time, while the phenomenological event turns into the ontological `to-come'. The double bindings of temporality and spatiality submerge to and emerge from the engagements of both tradition and the future, in an intricate exodus from and return to space-time.
The Coming of the 24-hour Economy?
Authors: Glorieux Ignace , Mestdag Inge , Minnen Joeri
Published: February 2008

This study mapped the changes in the timing of working hours in Belgium as reported in workers' daily work schedules, obtained from the Belgian Time-Use Surveys of 1966 and 1999. A typology of working schedules was drawn up by means of a sequence analysis. This approach showed that work performed beyond the standard times, that is, in the evening, at night, or on weekends, did not grow in importance in the intervening years. In 1999, standard working hours clearly accounted for a larger share of the work schedules of the active population. Although the analyses did certainly not corroborate the often alleged trend towards a 24-hour society in Belgium, it could be shown that certain categories of the working population are more susceptible to flexible working hours than others.
Recursive Derivation of One-Dimensional Models from Three-Dimensional Nonlinear Elasticity
Authors: Meunier Nicolas
Published: February 2008

In this paper, we consider a formal asymptotic study of homogeneous slender cylinders made of a Saint-Venant Kirchhoff material submitted to dead loads. Depending on the order of magnitude of the applied loads, we obtain a hierarchy of four one-dimensional models starting from the nonlinear theory of extensible strings to the nonlinear theory of flexible bars. Our approach is based on the resolution of a sequence of recursive minimization problems.
Internet-based monitoring of asthma symptoms, peak flow meter readings, and absence data in a school-based clinical trial
Authors: McClure Leslie A , Harrington Kathy F , Graham Holli , Gerald Lynn B
Published: February 2008

Background Asthma is the most common chronic childhood disease and has significant impact on morbidity and mortality in children. Proper adherence to asthma medication has been shown to reduce morbidity among those with asthma; however, adherence to medications is known to be low, especially among low-income urban populations. We conducted a randomized clinical trial to examine the effectiveness of an intervention designed to increase adherence to asthma medication among children with asthma that required daily collection of data.

Purpose and Methods A specifically designed web-based data collection system, the Asthma Agents System, was used to collect daily data from participant children at school. These data were utilized to examine the intervention's effectiveness in reducing the frequency of asthma exacerbations. This study examines the Asthma Agents System's effect on the frequency of missing data. Data collection methods are discussed in detail, as well as the processes for retrieving missing data.

Results For the 290 children randomized, 97% of the daily data expected were available. Of the outcome data retrieved via the Asthma Agents System, 5% of those expected were missing during the period examined.

Limitations Challenges encountered in this study include issues regarding the use of technology in urban school settings, transfer of data between study sites, and availability of data during school breaks.

Conclusions Use of the Asthma Agents System resulted in lower rates of missing data than rates reported elsewhere in the literature. Clinical Trials 2008; 5: 31—37. http://ctj.sagepub.com
Interim futility analysis with intermediate endpoints
Authors: Goldman Bryan , LeBlanc Michael , Crowley John
Published: February 2008

Background Interim analysis of Phase III trials typically includes testing for both efficacy and futility. Futility testing is commonly performed on the primary outcome at very low levels (e.g., one-sided α=0.0025) at one or two times before final analysis. When overall survival is the primary outcome and events accrue slowly, and if a suitable intermediate endpoint is available, then using this endpoint for interim futility testing may yield a higher probability of stopping early for futility in the absence of any treatment effect.

Purpose The purpose of this study is to explore the possibility of incorporating an intermediate endpoint into interim futility testing of Phase III trials.

Methods Using a simple two-stage exponential survival model based on recent Southwest Oncology Group Phase III studies in several disease settings, we perform a series of simulation studies. Survival data are simulated under both the null and alternative hypotheses, and analyzed using overall survival, progression-free survival, and a composite endpoint for futility testing.

Results In all disease settings examined here, when survival data were simulated under the null hypothesis, the probability of stopping a trial early for futility was substantially increased by incorporating PFS into interim futility analyses. When testing for futility with the composite endpoint, average patient accrual was reduced by 6—11% in a wide variety of disease settings. In the study scenario with the longest survival, the savings in study duration was more dramatic than in patient resources. When data were simulated under the alternative hypothesis, this procedure resulted in a negligible loss of power.

Limitations The properties of this procedure outside of the context of cancer clinical trials and/or using a different intermediate endpoint are not examined. These results also do not address its performance in the context of less conservative stopping rules.

Conclusions Interim futility monitoring of Phase III trials using a suitable intermediate endpoint may substantially increase the probability of stopping early for futility when there is no treatment effect. These simulation studies suggest that this would lead to meaningful reductions in study duration and patient resources in many disease settings, with no substantial loss of power for the primary test of efficacy. Future work is needed to explore in detail whether modifications to the stopping rules used in this procedure may yield greater savings without compromising power. Clinical Trials 2008; 5: 14—22. http://ctj.sagepub.com
Sensible approaches for reducing clinical trial costs
Authors: Eisenstein Eric L , Collins Rory , Cracknell Beena S , Podesta Oscar , Reid Elizabeth D , Sandercock Peter , Shakhov Yuriy , Terrin Michael L , Sellers Mary Ann , Califf Robert M , Granger Christopher B , Diaz Rafael
Published: February 2008

Background Over the past decade, annual funding for biomedical research has more than doubled while new molecular entity approvals have declined by one third.

Objective To assess the value of practices commonly employed in the conduct of large-scale clinical trials, and to identify areas where costs could be reduced without compromising scientific validity.

Methods In the qualitative phase of the study, an expert panel recommended potential modifications of mega-trial designs and operations in order to maximize their value (cost versus scientific benefit tradeoff). In the quantitative phase, a mega-trial economic model was used to assess the financial implications of these recommendations. Our initial chronic disease trial design included 20,000 patients randomized at 1000 sites. Each site was assigned 24 monitoring visits and a $10,000 per patient site payment. The case report form (CRF) was 60 pages long, and trial duration was assumed to be 48 months.

Results The total costs of the initial trial design were $421 million ($US 2007). Following the expert panel's recommendations, we varied study duration, CRF length, number of sites, electronic data capture (EDC), and site management components to determine their individual and combined effects upon total trial costs. The use of EDC and modified site management practices were associated with significant reductions in total trial costs. When reductions in all five trial components were combined in a streamlined pharmaceutical industry design, a 59% reduction in total trial costs resulted. When we assumed an even more streamlined trial design than has typically been considered for regulatory submissions in the past, there was a 90% reduction in total trial costs.

Conclusion Our results suggest that it is possible to reduce substantially the cost of large-scale clinical trials without compromising the scientific validity of their results. If implemented, our recommendations could free billions of dollars annually for additional clinical studies. Research in the setting of clinical trials should be conducted to refine these findings. Clinical Trials 2008; 5: 75—84. http:// ctj.sagepub.com
Randomized Trials in Vulnerable Populations
Authors: Cook Deborah , Moore-Cox Anne , Xavier Denis , Lauzier François , Roberts Ian
Published: February 2008

Many persons enrolled in clinical trials can be considered vulnerable, and such trials often raise concerns because of the diminished ability of vulnerable persons to consider and protect their own interests. However, this research is necessary to answer important questions, such as which interventions are effective, which have no impact, and which do more harm than good. In this article, we identified six specific challenges associated with randomized clinical trials in vulnerable populations and have suggested several potential solutions to overcome these challenges. First addressed were macro issues, such as the scope of the problem, and research capacity in terms of funding and investigators. Next, we have addressed research ethics review, informed consent, regulatory hurdles, and serious adverse event reporting. As clinical trials are expanding globally, all stakeholders (investigators, granting agencies, REBs, DSMBs, regulatory bodies, universities, hospitals, clinicians, patients, and family members) should be aware of the challenges we have outlined, and work collaboratively toward effective solutions that improve the quality, quantity, safety, and relevance of clinical trials for vulnerable persons around the world. Clinical Trials 2008; 5: 61—69. http://ctj.sagepub.com
Ensuring trial validity by data quality assurance and diversification of monitoring methods
Authors: Baigent Colin , Harrell Frank E , Buyse Marc , Emberson Jonathan R , Altman Douglas G
Published: February 2008

Errors in the design, the conduct, the data collection process, and the analysis of a randomized trial have the potential to affect not only the safety of the patients in the trial, but also, through the introduction of bias, the safety of future patients. Trial monitoring, defined broadly to include methods of oversight which begin when the study is designed and continue until it is reported in a publication, has a role to play in eliminating such errors. On-site monitoring can be extremely inefficient for the identification of errors most likely to compromise patient safety or bias study results. However, a variety of other monitoring strategies offer alternatives to on-site monitoring. Each new trial should conduct a risk assessment to identify the optimal means of monitoring, taking into account the likely sources of error, their consequences for patients, the study's validity, and the available resources. Trial management committees should consider central statistical monitoring a key aspect of such monitoring. The systematic application of this approach would be likely to lead to tangible benefits, and resources that are currently wasted on inefficient on-site monitoring could be diverted to increasing trial sample sizes or conducting more trials. Clinical Trials 2008; 5: 49—55. http://ctj.sagepub.com
The impact of privacy and confidentiality laws on the conduct of clinical trials
Authors: Armitage Jane , Souhami Robert , Friedman Lawrence , Hilbrich Lutz , Holland Jack , Muhlbaier Lawrence H. , Shannon Jane , Van Nie Alison
Published: February 2008

Justifiable concerns about the use of personal data in many aspects of daily life have led to the recent introduction in many countries of laws intended to regulate data use. Although participation in randomized clinical trials is generally with informed consent, recruitment procedures, complete follow-up, and the efficient conduct of trials may be substantially affected by such national or local privacy legislation. The relevant laws often have exceptions that allow the use of patient information in the public interest — including the use of data collected to improve or monitor public health or as part of medical research. However, regulatory bodies often give conflicting interpretations of the law, and this affects the conduct of large-scale trials.

In particular, unnecessarily restrictive interpretation of the law may be a serious impediment to identification of potential participants for a trial, access to records to confirm events, continued follow-up of patients after the trial has been concluded, and secondary use of the trial data for purposes not directly related to the original purpose of the study. These obstacles could be overcome by better informing patients of the uses of records for medical research purposes, by using informed consent procedures that explain the nature of the research and the uses of the data, and by the use of identifiers, such as social security numbers that allow central follow-up.

The clinical trial research community needs to ensure that the substantial benefits of large-scale randomized trials are explained both to the public and to those responsible for introducing legislation. The negative impact of privacy legislation on the use of personal health information and on conducting large studies needs to be understood and minimized. Clinical Trials 2008; 5: 70—74. http://ctj.sagepub.com
Estimating effects from randomized trials with discontinuations: the need for intent-to-treat design and G-estimation
Authors: Greenland Sander , Lanes Stephan , Jara Michele
Published: February 2008

Background Randomized trials provide pivotal evidence for evaluation and approval of therapies. Nonetheless, such trials are often plagued by noncompliance, especially in the form of premature discontinuation of treatment. While intent-to-treat (ITT) analysis can provide valid tests of no-effect hypotheses, some trials may make ITT analysis impossible by ceasing follow-up when patients go off assigned treatment. Furthermore, estimates based on ITT, on-treatment, or per-protocol comparisons can seriously understate harm or benefit.

Purpose To show how g-estimation based on randomization status is a natural generalization of ITT null testing to estimating efficacy from trials with important discontinuation or noncompliance.

Methods We contrast with an analysis of the effect of a tiotropium inhaler on the occurrence of chronic obstructive pulmonary disease (COPD) events in a six-month double-blind placebo-controlled trial of 1829 patients with good but imperfect compliance.

Results The covariate-adjusted point estimates, 95% confidence limits (CL), and null P-values comparing expected COPD event times in placebo versus tiotropium patients were: ITT, 1.21, CL = 1.02, 1.43, P = 0.027; on-treatment, 1.27, CL = 1.06, 1.52, P = 0.009; per-protocol, 1.36, CL = 1.13, 1.63, P = 0.001; and g-estimation, 1.31, CL = 1.03,1.72, P = 0.027. Thus g-estimation preserved the ITT test of the null, but exhibited more uncertainty about the size of the tiotropium effect than the other methods. In particular, it allowed for a much larger potential effect than did ITT analysis, but produced a much larger null P than exhibited by per-protocol analysis. Limitations Like ITT analysis, g-estimation requires all patients be followed to the end of the trial protocol, regardless of whether they comply with the protocol. Like on-treatment and per-protocol analyses, it also requires accurate compliance information be recorded.

Conclusion G-estimation should become a standard procedure for the analysis of trials with noncompliance. Software to do so is available in major packages, and the procedure is easily coded for other packages. Clinical Trials 2008; 5: 5—13. http://ctj.sagepub.com