Browsing by Subject "Serious illness"

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    Improving the Approach to Defining, Classifying, Reporting and Monitoring Adverse Events in Seriously Ill Older Adults: Recommendations from a Multi-stakeholder Convening
    (Springer, 2023) Baim-Lance, Abigail; Ferreira, Katelyn B.; Cohen, Harvey Jay; Ellenberg, Susan S.; Kuchel, George A.; Ritchie, Christine; Sachs, Greg A.; Kitzman, Dalane; Morrison, R. Sean; Siu, Albert; Medicine, School of Medicine
    Background: Clinical trials are needed to study topics relevant to older adults with serious illness. Investigators conducting clinical trials with this population are challenged by how to appropriately define, classify, report, and monitor serious and non-serious adverse events (SAEs/AEs), given that some traditionally reported AEs (pressure ulcers, delirium) and SAEs (death, hospitalization) are common in persons with serious illness, and may be consistent with their goals of care. Objectives: A multi-stakeholder group convened to establish greater clarity on and new approaches to address this critical issue. Participants: Thirty-two study investigators, members of regulatory and sponsor agencies, and patient stakeholders took part. Approach: The group met virtually four times and, using a collaborative approach, conducted a survey, select interviews, and reviewed regulatory guidance to collectively define the problem and identify a new approach. Results: SAE/AE challenges fell into two areas: (1) definitions and classifications, including (a) implausible relationships, (b) misalignment with patient-centered care goals, and (c) well-known associations, and (2) reporting and monitoring, including (a) limited guidance, (b) inconsistent standards across regulators, and (c) Data Safety Monitoring Board (DSMB) member knowledge gaps. Problems largely reflected practice norms rather than regulatory requirements that already support context-specific and aggregate reporting. Approaches can be improved by adopting principles that better align strategies for addressing adverse events with the type of intervention being tested, favoring routine and aggregate over expedited reporting, and prioritizing how SAE/AEs relate to patient-centered care goals. Reporting plans and decisions should follow an algorithm underpinned by these principles. Conclusions: Adoption of the proposed approach-and supporting it with education and better alignment with regulatory guidance and procedures-could improve the quality and efficiency of clinical trials' safety involving older adults with serious illness and other vulnerable populations.
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    Time to Develop Guidelines for Spiritual Care in Serious Illness
    (Mary Ann Liebert, 2024-09-06) Varner-Perez, Shelley E.; Comer, Amber R.; Fitchett, George; Medicine, School of Medicine
    In 2022, a JAMA systematic review of 342 high quality studies called for spiritual care to be a routine part of care for patients with serious illness. The review's multidisciplinary panel made several recommendations for addressing patients' and families' spiritual concerns. Despite these evidence-based recommendations, there are no clinical guidelines that inform when and how such spiritual care should be provided. We propose convening a multi-disciplinary workgroup to generate specific and actionable guidelines for incorporating spiritual care in serious illness care. We suggest three workgroup priorities: (1) determining best approaches to identifying patient and family members' spiritual care needs; (2) developing ways to integrate chaplains into routine clinical care; and (3) determining best approaches to communicate availability of spiritual care. Developing these guidelines is an imperative next step to deliver high quality, person and family-centered care.
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    Top Ten Tips Palliative Care Clinicians Should Know About Delivering Antiracist Care to Black Americans
    (Mary Ann Liebert, 2022) Jones, Katie Fitzgerald; Laury, Esther; Sanders, Justin J.; Starr, Lauren T.; Rosa, William E.; Booker, Staja Q.; Wachterman, Melissa; Jones, Christopher A.; Hickman, Susan; Merlin, Jessica S.; Meghani, Salimah H.; School of Nursing
    Racial disparities, including decreased hospice utilization, lower quality symptom management, and poor-quality end-of-life care have been well documented in Black Americans. Improving health equity and access to high-quality serious illness care is a national palliative care (PC) priority. Accomplishing these goals requires clinician reflection, engagement, and large-scale change in clinical practice and health-related policies. In this article, we provide an overview of key concepts that underpin racism in health care, discuss common serious illness disparities in Black Americans, and propose steps to promote the delivery of antiracist PC.