Exploring and validating surrogate endpoints in colorectal cancer

Sargent et al (J Clin Oncol 23: 8664–8670, 2005) concluded that 3-year disease-free survival (DFS) can be considered a valid surrogate (replacement) endpoint for 5-year overall survival (OS) in clinical trials of adjuvant chemotherapy for colorectal cancer. We address the question whether the conclusion holds for trials involving other classes of treatments than those considered by Sargent et al. Additionally, we assess if the 3-year cutpoint is an optimal one. To this aim, we investigate whether the results reported by Sargent et al. could have been used to predict treatment effects in three centrally randomized adjuvant colorectal cancer trials performed by the Japanese Foundation for Multidisciplinary Treatment for Cancer (JFMTC) (Sakamoto et al. J Clin Oncol 22:484–492, 2004). Our analysis supports the conclusion of Sargent et al. and shows that using DFS at 2 or 3 years would be the best option for the prediction of OS at 5 years.     

The issue of consent in research that administers drugs of addiction to addicted persons

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.     

On the Addition and Comparison of Graphs Labeled with Stochastic Variables: Learnable Anatomical Catalogs

We provide an operator for the addition of a pair of graphs, labeled with continuous variables which are subject to stochastic variation. We also provide an operator for measuring dissimilarity between a pair of such graphs. We use such a representation and operators to model a collection of vascular anatomy which accounts for inter-individual variations in both branching structure and in vessel shape. The model may be incrementally acquired, and is thus a catalog of anatomy whose content may be learned. The model may be used in applications such as the reconstruction of vasculature in three-dimensions from x-ray images, which we briefly outline.     

The social inclusion policy agenda in Australia: a case of old wine,new bottles?

The election of an Australian Labor Government in Australia in 2007 saw ‘social inclusion’ emerge as the official and overarching social policy agenda. Being ‘included’ was subsequently defined by the ALP Government as being able to ‘have the resources, opportunities and capabilities needed to learn, work, engage and have a voice‘. Various researchers in Australia demonstrated an interest in social inclusion, as it enabled them to construct a multi‐dimensional framework for measuring disadvantage. This research program resulted in various forms of statistical modelling based on some agreement about what it means to be included in society. The multi‐dimensional approach taken by academic researchers, however, did not necessarily translate to a new model of social policy development or implementation. We argue that, similar to the experience of the UK, Australia's social inclusion policy agenda was for the most part narrowly and individually defined by politicians and policy makers, particularly in terms of equating being employed with being included. We conclude with discussion about the need to strengthen the social inclusion framework by adopting an understanding of social inequality and social justice that is more relational and less categorical.     

Qualitative exploration of the nature of grief-related beliefs and expectations

Societal expectations of grief impact the experience of bereavement. The congruence of societal expectations with current scientific understanding of grief is unknown. Therefore two qualitative studies explored community perceptions of grief. In study one, three small focus groups (N = 9) examined grief-related expectations associated with hypothetical scenarios of bereavement. In study two, the impact of grief-related perceptions on the lived experience of bereavement for 11 individuals was explored through semi-structured interviews. Across both studies, elements of a traditional stage model view of grief were evident, with participants viewing emotional expression of grief as important. An avoidant coping style in the bereaved was considered problematic. Findings of study two suggested that grief-related beliefs may impact the bereavement experience via appraisal of the grief response and willingness to support bereaved individuals. The studies suggested that stage model assumptions in the beliefs of the general population persist, although there was a recognition of diversity in the grief response.     

Who to Serve? The Ethical Dilemma of Employment Consultants in Nonprofit Disability Employment Network Organisations

The Welfare‐to‐work policy, implemented in July 2006 by the Federal Government, imposed a new work and activity obligation on people applying for the Disability Support Pension. This requirement not only created a new obligation for people with disability but also for employment consultants working in nonprofit Disability Employment Network organisations to monitor the conduct of this new cohort on behalf of Centrelink. For many employment consultants traditionally drawn to the nonprofit disability sector for altruistic reasons, this has created an ethical dilemma between their duty to their employer, and acting in the best interests of their clients. Drawing on aspects of ethical theory we find that, although most employment consultants justify their actions in terms of duty to the organisation, some find themselves in an ethical dilemma of ‘who to serve’ when the interests of the organisation and the welfare of the client are mismatched.     

Iowa Case Management for Rural Drug Abuse

OBJECTIVE: The purpose of this research was to evaluate the effectiveness of a comprehensive, strengths-based model of case management for clients in drug abuse treatment. METHOD: 503 volunteers from residential or intensive outpatient treatment were randomly assigned to one of three conditions of Iowa Case Management (ICM) plus treatment as usual (TAU), or to a fourth condition of TAU only. All were assessed at intake and followed at 3, 6, and 12 months. RESULTS: Clients in all four conditions significantly decreased substance use by 3 months after intake and maintained most gains over time. However, the addition of ICM to TAU did not improve substance use outcomes. CONCLUSION: Overall, the addition of case management did not significantly improve drug treatment as hypothesized by both researchers and clinicians. Some results were mixed, possibly due to the heterogeneous sample, wide range of case management activities, or difficulty retaining participants over time.     

Connecting child care quality to child outcomes: drawing policy lessons from nonexperimental data

Effective early childhood intervention and child care policies should be based on an understanding of the effects of child care quality and type on child well-being. This article describes methods for securing unbiased estimates of these effects from nonexperimental data. It focuses on longitudinal studies like the one developed by the National Institute of Child Health and Human Development's Early Child Care Research Network. This article first describes bias problems that arise in analyses of nonexperimental data and then explains strategies for controlling for biases arising from parental selection of child care. Next, it comments on attrition in longitudinal studies and outlines some strategies for addressing possible attrition bias. Finally, it discusses the need to translate "effect sizes" derived from these studies into the kinds of cost and benefit information needed by policy makers.     

Aftermath of tragic events: the development and use of community support meetings on a university campus

Colleges and universities need to be prepared to address the psychological impact of tragedies on their campuses. In this article, the author describes the development and successful implementation of campus postvention services in the aftermath of college student deaths by suicide as well as by natural and accidental causes. The program has been well received and has gone a long way toward helping the campus community come together and heal after these types of tragedies. College officials adapted the program to address issues related to troubling national and international events as well local incidents, such as suicide attempts and students' loss of housing through fires. The author provides specific instructions so that readers can replicate the program on their own campuses, and additional materials are available upon request.