Data and safety monitoring in social behavioral intervention trials: the REACH II experience

Background Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials. Purpose This paper summarizes how issues associated with safety monitoring and adverse event reporting were handled in the Resources for Enhancing Alzheimer\u27s Caregiver Health (REACH II) program, a multi-site randomized clinical trial, funded by the National Institutes on Aging (NIA) and the National Institutes of Nursing Research (NINR), that tested the efficacy of a multicomponent social/behavioral intervention for caregivers of persons with Alzheimer\u27s disease. Methods A task force was formed to define adverse events for the trial and protocols for reporting and resolving events that occurred. The task force conducted a review of existing polices and protocols for data and safety monitoring and adverse event reporting and identified potential risks particular to the study population. An informal survey regarding data and safety monitoring procedures with investigators on psychosocial intervention trials was also conducted. Results Two categories of events were defined for both caregivers and patients; adverse events and safety alerts. A distinction was also made between events detected at baseline assessment and those detected post-randomization. Standardized protocols were also developed for the reporting and resolution of events that occurred and training of study personnel. Results from the informal survey indicated wide variability in practices for data safety and monitoring across psychosocial intervention trials. Conclusions Overall, the REACH II experience demonstrates that existing guidelines regarding safety monitoring and adverse event reporting pose unique challenges for social/behavioral intervention trials. Challenges encountered in the REACH II program included defining and classifying adverse events, defining resolution of adverse events and attributing causes for events that occurred. These challenges are highlighted and recommendations for addressing them in future studies are discussed

Assessing Disease Activity in Psoriatic Arthritis: A Literature Review

Psoriatic arthritis (PsA) is a multifaceted disease, with a high impact on patients’ psychological and physical well-being. There is increasing recognition that assessment of both clinical aspects of disease and patient identified concerns, such as fatigue, work disability, and treatment satisfaction need to be addressed. Only then can we fully understand disease burden and make well-informed treatment decisions aimed at improving patients’ lives. In recent years, there has been much progress in the development of unidimensional and composite measures of disease activity, as well as questionnaires capturing the patient’s perspective in psoriatic disease. Despite these advances, there remains disagreement amongst clinicians as to which instruments should be used. As a consequence, they are yet to receive widespread implementation in routine clinical practice. This review aims to summarize currently available clinical and patient-derived assessment tools, which will provide clinicians with a practical and informative resource

A community of practice or a working psychological group? Group dynamics in core and peripheral community participation

The concept of communities of practice (CoP) has become increasingly influential in management literature. Yet, many scholars regard the term as too homogenous and lacking in empirical support. Our study explores the Silver Academy, a project involving over 100 unemployed and self-employed managers over the age of 50, who came together with the purpose of sharing knowledge and experience in starting up their own businesses. The study shows how the Academy matches the notion of CoP including mutual relationships, shared engagement and a common consensus of membership. However, applying Bion’s (1961) theory of groups, we challenge the homogenous and consensual notion of a community of practice, illustrating how, through unconscious group processes, some group members exhibit workgroup mentality and the capacity for realistic hard work (and leadership), while others are caught in a basic-assumption mentality, prone to feelings of anxiety, guilt and depression. This is particularly so for a group that has gone through the recent trauma of unemployment

Business not as usual: how multisectoral collaboration can promote transformative change for health and sustainable development.

• We present a model of enabling fac-tors for effective multisectoral collabo-ration for improvements in health and sustainable development. • Drive change: assess whether desired change is better off achieved by mul-tisectoral collaboration; drive forward collaboration by mobilising a critical mass of policy and public attention. • Define: frame the problem strategi-cally and holistically so that all sec-tors and stakeholders can see the benefits of collaboration and contri-bution to the public good• Design: create solutions relevant to context, building on existing mecha-nisms, and leverage the strengths of diverse sectors for collective impact. • Relate: ensure resources for multi-sectoral collaboration mechanisms, including for open communication and deliberation on evidence, norms, and innovation across all components of collaboration. • Realise: learn by doing, and adapt with regular feedback. Remain open to redefining and redesigning the collaboration to ensure relevance, effectiveness, and responsiveness to change. • Capture success: agree on success markers, using qualitative and quan-titative methods to monitor results regularly and comprehensively, and learn from both failures and successes to inform action and sustain gains