Browsing by Author "Morrison, R. Sean"

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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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    Quality "start up" measures and instruments
    (2006-11-03) Morrison, R. Sean
    Guidelines for conducting a statistical research project on palliative care.
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    A Research Agenda for Communication Between Health Care Professionals and Patients Living With Serious Illness
    (AMA, 2017-09) Tulsky, James A.; Beach, Mary Catherine; Butow, Phyllis N.; Hickman, Susan E.; Mack, Jennifer W.; Morrison, R. Sean; Street, Richard L., Jr.; Sudore, Rebecca L.; White, Douglas B.; Pollak, Kathryn I.; School of Nursing
    Importance Poor communication by health care professionals contributes to physical and psychological suffering in patients living with serious illness. Patients may not fully understand their illness, prognosis, and treatment options or may not receive medical care consistent with their goals. Despite considerable research exploring the role of communication in this setting, many questions remain, and a clear agenda for communication research is lacking. Observations Through a consensus conference and subsequent activities, we reviewed the state of the science, identified key evidence gaps in understanding the impact of communication on patient outcomes, and created an agenda for future research. We considered 7 broad topics: shared decision making, advance care planning, communication training, measuring communication, communication about prognosis, emotion and serious illness communication, and cultural issues. We identified 5 areas in which further research could substantially move the field forward and help enhance patient care: measurement and methodology, including how to determine communication quality; mechanisms of communication, such as identifying the specific clinician behaviors that patients experience as both honest and compassionate, or the role of bias in the clinical encounter; alternative approaches to advance care planning that focus on the quality of serious illness communication and not simply completion of forms; teaching and disseminating communication skills; and approaches, such as economic incentives and other clinician motivators, to change communication behavior. Conclusions Our findings highlight the urgent need to improve quality of communication between health care professionals and patients living with serious illness through a broad range of research that covers communication skills, tools, patient education, and models of care.