Strategy management in collaborative clinical research partnerships.

PURPOSE: Today's clinical trial partnerships frequently join multi-disciplinary investigators and stakeholders, from different countries and cultures, to conduct research with a broad array of goals. This diversity, while a strength, can also foster divergent views about priorities and what constitutes success, thereby posing challenges for management, operations, and evaluation. As a sponsor and partner in such collaborations, we seek to assist and support their development and implementation of sound research strategies, to optimize their efficiency, sustainability, and public health impact. This report describes our efforts using an adaptation of the well-established Kaplan-Norton strategy management paradigm, in our clinical trials setting. We share findings from our first test of the utility and acceptance of this approach for evaluating and managing research strategies in a collaborative clinical research partnership. RESULTS: Findings from pilot studies and our first implementation in an ongoing clinical research partnership in Liberia, provide initial support for our hypothesis that an adapted version of the Kaplan-Norton strategy management model can have use in this setting. With leadership from within the partnership, analysis artifacts were gathered, and assessments made using standardized tools. Practical feasibility, resonance of the findings with partners, and convergence with other empirical assessments lend initial support for the view that this approach holds promise for obtaining meaningful, useable results for assessing and improving clinical research management. CONCLUSIONS AND IMPLICATIONS: Engaged leadership, thoughtful timing to align with partnership planning cycles, support for the process, and an eye towards the collaboration's long-term goals appear important for developing model understanding and practice. Skepticism about evaluations, and unease at exposing weaknesses, may hinder the effort. Acceptance of findings and associated opportunities for improvement by group leadership, support a growing sense of validity. Next steps aim to test the approach in other partnerships, streamline the methodology for greater ease of use, and seek possible correlations of strategy management assessments with performance evaluation. There is hardly a better example than the COVID-19 pandemic, to spotlight the need for efficient and effective clinical research partnerships to address global health challenges. While heartened by the collaborative spirit driving the effort so far, we cannot let our enthusiasm lull us into thinking that nobility of purpose or an abundance of good will is sufficient. Careful monitoring and adjustment of clinical research strategy in response to changes (e.g., demographics, pathogen evolution, research acceptance, political and cultural environments) are vital to making the needed adjustments that can guide these programs toward successful outcomes. We hope that our work can raise awareness about the importance, relevance, and feasibility of sound strategy management in clinical research partnerships, especially during this time when there is so much at stake.

Resource Loss and Stress Outcomes in a Setting of Chronic Conflict: The Conservation of Resources Theory in the Eastern Congo.

The purpose of this cross-sectional study was to examine conservation of resources (COR) theory in the context of armed conflict in Africa. Specifically, within the setting of ongoing chronic conflict in the eastern Democratic Republic of the Congo (DRC), we tested the COR theory prediction that resource loss contributes to various stress outcomes. A randomly selected sample of 312 adults (125 men, 187 women) from villages in North Kivu, DRC completed orally administered measures of resource loss, daily stressors, and four stress outcomes: depression symptoms, anxiety symptoms, posttraumatic distress, and general distress. Consistent with COR theory, resource loss predicted all four stress outcomes above and beyond the contribution of demographics, relocation experiences, and daily stressors; however, this effect was small, ΔR2 = .02-.06. The most consistent and strongest predictors of stress outcomes were daily stressors, ßs = .42-.62; number of relocation experiences, ßs = .33-.43; and psychosocial resource loss (e.g., loss of hope, meaning or purpose in life, intimacy with friends and family, physical health of family), ßs = .17-.26. Additionally, male sex predicted depression, anxiety, and trauma symptoms, and lower educational status predicted anxiety symptoms and general distress. Our exploratory mediation analysis showed that daily stressors partially mediated all four pairs of associations between psychosocial resource loss and mental health outcomes. We discuss the findings with consideration of research on disasters generally and armed conflicts specifically. We also discuss implications for humanitarian interventions with conflict-affected populations in Africa and beyond.

Cultural Humility and Hospital Safety Culture.

Hospital safety culture is an integral part of providing high quality care for patients, as well as promoting a safe and healthy environment for healthcare workers. In this article, we explore the extent to which cultural humility, which involves openness to cultural diverse individuals and groups, is related to hospital safety culture. A sample of 2011 hospital employees from four hospitals completed measures of organizational cultural humility and hospital safety culture. Higher perceptions of organizational cultural humility were associated with higher levels of general perceptions of hospital safety, as well as more positive ratings on non-punitive response to error (i.e., mistakes of staff are not held against them), handoffs and transitions, and organizational learning. The cultural humility of one's organization may be an important factor to help improve hospital safety culture. We conclude by discussing potential directions for future research.

Trauma in sub-Saharan Africa: review of cost, estimation methods, and interventions.

Trauma is a widely acknowledged problem facing individuals and communities in developing countries. In sub-Saharan Africa-a region that is home to some of the world's worst human rights violations, ethnic and civil conflicts, disease epidemics, and conditions of poverty-trauma is an all-too-common experience in citizens' daily lives. In order to address these conditions effectively, the impact of trauma must be understood. The authors reviewed recent literature on the cost and consequences of psychological trauma in sub-Saharan Africa to provide a substantive perspective on how trauma affects individuals, communities, and organizations and to inform the effort to determine a method for measuring the impact of trauma in sub-Saharan Africa and the efficacy of trauma interventions in the region. Several recommendations are offered to help broaden and deepen the current approaches to conceptualizing trauma, evaluating its cost, and intervening on behalf of those impacted by trauma in sub-Saharan Africa.

Church attendee help seeking priorities after Hurricane Katrina in Mississippi and Louisiana: a brief report.

After a disaster, survivors find themselves seeking many types of help from others in their communities. The purpose of this exploratory study was to assist in mental health service planning by determining the type and priority of support services sought by church attendees after Hurricane Katrina. Surveys were given to church attendees from two Mississippi coast and four New Orleans area churches that were directly affected by Hurricane Katrina participants were asked to review a list of 12 potential sources of help and were asked to rank the items chronologically from whom they had sought help first after Hurricane Katrina. Overall, participants sought out assistance from informal social networks such as family and friends first, followed by governmental and clergy support. This study also showed there may be differences in help-seeking behaviors between church attendees in more urban areas versus church attendees in more rural areas. Moreover, findings highlighted that very few church attendees seek out mental health services during the initial impact phase of a disaster. Since timely engagement with mental health services is important for resolving trauma, strategies that link professional mental health services with clergy and government resources following a disaster could improve the engagement with mental health professionals and improve mental health outcomes. Disaster mental health clinical implications and recommendations are offered for psychologists based on these findings.

Changing culture in the home health setting: strategies for success.

Organizational culture is generally defined as the internal attributes of the staff, such as their values, beliefs, and attitudes. Although technically accurate as a definition, personal attributes defy direct intervention, leading some to question whether it is possible to change culture. It is proposed that it is possible to change the personal internal attributes that define organizational culture by changing the characteristic structures and behaviors of the organization that shape those attributes. This model, called the Quality Capability Model, creates an approach to culture change that accommodates the unique features of home health.

Developing standards of care: a tale of two panels.

OBJECTIVE: How will a group of experts convened to develop standards of care communicate in meaningfully different ways when interacting online in contrast to traditional face-to-face meetings. Furthermore, does online interaction facilitate discussion among participants from diverse cultural backgrounds and at what cost? DESIGN: A project to develop standards of care for deaf and hard of hearing adults used two panels of experts operating in two different formats: online and face-to-face. One panel interacted via an online system while the other met in a day-long face-to-face conference. As one component of the project, we tracked the interactions of these two groups in order to describe and contrast their group processes. STUDY PARTICIPANTS: The subjects were volunteer experts in hearing impairment and health care, from organizations across the United States. They were a geographically diverse group with widely varying communication needs. We applied two different systems for facilitating communication among culturally diverse participants, and assessed interaction and satisfaction. MAIN OUTCOME MEASURES: Data were collected on the two groups on the pattern of interactions, satisfaction with the process, and satisfaction with outcomes. RESULTS: The results showed a high level of user satisfaction with both process and outcomes, and provide data for a description of the source of user satisfaction and the management of the groups. CONCLUSION: Online interaction offers unique advantages but poses unique management requirements for success.