Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach

In May 2013, GlaxoSmithKline (980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) established a new online system to enable scientific researchers to request access to anonymised patient level clinical trial data. Providing access to individual patient data collected in clinical trials enables conduct of further research that may help advance medical science or improve patient care. In turn, this helps ensure that the data provided by research participants are used to maximum effect in the creation of new knowledge and understanding. However, when providing access to individual patient data, maintaining the privacy and confidentiality of research participants is critical. This article describes the approach we have taken to prepare data for sharing with other researchers in a way that minimises risk with respect to the privacy and confidentiality of research participants, ensures compliance with current data privacy legal requirements and yet retains utility of the anonymised datasets for research purposes. We recognise that there are different possible approaches and that broad consensus is needed. Copyright © 2014 John Wiley & Sons, Ltd.     

The Quality of Male Fertility Data in Major U.S. Surveys

Researchers continue to question fathers’ willingness to report their biological children in surveys and the ability of surveys to adequately represent fathers. To address these concerns, this study evaluates the quality of men’s fertility data in the 1979 and 1997 cohorts of the National Longitudinal Survey of Youth (NLSY79 and NLSY97) and in the 2002 National Survey of Family Growth (NSFG). Comparing fertility rates in each survey with population rates based on data from Vital Statistics and the U.S. Census Bureau, we document how the incomplete reporting of births in different surveys varies according to men’s characteristics, including their age, race, marital status, and birth cohort. In addition, we use Monte Carlo simulations based on the NSFG data to demonstrate how birth underreporting biases associations between early parenthood and its antecedents. We find that in the NSFG, roughly four out of five early births were reported; but in the NLSY79 and NLSY97, almost nine-tenths of early births were reported. In all three surveys, incomplete reporting was especially pronounced for nonmarital births. Our results suggest that the quality of male fertility data is strongly linked to survey design and that it has implications for models of early male fertility.     

Outpatient Dialectical Behavior Therapy for Adolescents Engaged in Deliberate Self-Harm: Conceptual and Methodological Considerations

The current review examines conceptual and methodological issues related to the use of dialectical behavior therapy for adolescents (DBT-A) in treating youth who engage in deliberate self-harm. A comprehensive review of the literature identified six studies appropriate for the review. Results indicated several inconsistencies and limitations across studies including the mixing of various forms of self-harm; variations in diagnostic inclusion/exclusion criteria, insufficient use of standardized self-harm outcome measures, variable lengths and intensity of provided treatment, and inadequate attention paid to DBT adherence. Each of these areas is reviewed along with a discussion of ways to improve the quality of future research.     

A Cross-Sectional Examination of the Association Between Dyspnea and Distress as Experienced by Palliative Home Care Clients and Their Informal Caregivers

This study examined the association between dyspnea and distress as experienced by both palliative home care clients and their informal caregivers as a unit of care. Cross-sectional analysis was conducted using the interRAI Palliative Care Assessment database. Responses from 6,655 individual palliative home care clients across six regional jurisdictions in Ontario, Canada were included. This study found that clients experiencing dyspnea were more likely to show overall signs of distress; report one or more signs of self-reported distress; and be at risk for depression when compared to clients who do not experience dyspnea. Caregivers of clients experiencing dyspnea were more likely to exhibit distress than caregivers of clients not reporting dyspnea. When indicators of caregiver distress and client distress were combined, 53% of the caregiver-client units exhibited distress. Social work practitioners should include a focus on distress within the care unit as a priority when care planning to meet the needs of persons nearing the end of life. Members of the care team should consider available treatment and management options tailored to meet both the client and their informal caregiver’s needs.     

Of the Soul and Suffering: Mindfulness-Based Interventions and Bereavement

There has been increased interest in, and evidence for, mindfulness-based interventions (MBIs) as integrative approaches for a wide variety of psychosocial issues. However, there is very little research on the use of MBIs in bereavement care and only one proposed model existing in the literature. This article presents an overview of the mindfulness-based literature and uses a case study of a bereaved parent to illustrate a mindfulness-based model of bereavement care that is consistent with social work values. Such a model may provide a future direction for care of the bereaved as well as interesting opportunities for further development and research.     

Centrality in social networks: ii. experimental results

Three competing hypotheses about structural centrality are explored by means of a replication of the early MIT experiments on communication structure and group problem-solving. It is shown that although two of the three kinds of measures of centrality have a demonstrable effect on individual responses and group processes, the classic measure of centrality based on distance is unrelated to any experimental variable. A suggestion is made that the positive results provided by distance-based centrality in earlier experiments is an artifact of the particular structures chosen for experimentation.