Table 1.
Meeting | Date | # Attended | Topics | Organizations represented |
---|---|---|---|---|
Meeting 1: convening process and participant review | 10/23/2020 | 22 |
• Introduction and background on issue • Aims of project • Draft outline of process and planned meetings • Feedback on proposed process and participants • Discussion on topics including the importance of defining the nature of the problem |
• American Geriatrics Society (AGS) • Ariadne Labs* • Brigham and Women’s Hospital* • Duke University School of Medicine • Harvard Medical School • Icahn School of Medicine at Mount Sinai • Indiana University • Marcus Institute for Aging Research* • Massachusetts General Hospital • National Institute on Aging (NIA) • National Palliative Care Research Center (NPCRC) • National Patient Advocate Foundation (NPAF)* • Office for Human Research Protections (OHRP) • Palliative Care Research Cooperative Group (PCRC) • Patient-Centered Outcomes Research Institute (PCORI)* • U.S. Department of Veteran Affairs - Veterans Health Administration - Geriatric Research Education and Clinical Centers (GRECCs) • U.S. Food and Drug Administration • University of Connecticut Center on Aging • University of Pennsylvania Perelman School of Medicine* • Wake Forest School of Medicine *Organization included after meeting 1. |
Meeting 2: problem identification | 1/20/2021 | 24 |
• Current SAE reporting process • Challenges of current SAE definitions and process for studies on older adults with serious illness: investigator perspectives • Federal agency perspectives and reactions (National Institute on Aging and Office for Human Research Protections) |
|
Meeting 3: Potential alternative approaches identification | 2/22/2021 | 28 |
• Summary/debrief of last meeting and process changes • U.S. Food and Drug Administration perspectives • Group discussion and brainstorm regarding possible alternatives to current approaches |
|
Meeting 4: Strategies to advance alternative approaches | 8/25/2021 | 19 |
• Review of feedback on problem definitions • Discussion of proposed new approaches • Building roadmap for advancing new approach • Active dissemination strategies |