Search

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.

The safety net, a collection of public hospitals, federally qualified health centers (FQHCs), and publicly funded community-based healthcare entities, provides essential care to middle-aged and older adults with geriatric conditions. The role of the safety net for these adults will intensify over the next two decades with the growing numbers of middle-aged and older adults with adverse social determinants of health and premature geriatric conditions. The foundation for addressing their needs is to detect geriatric conditions and then focus care plans on the impact of these factors on function, which predicts mortality and quality of life more than chronic conditions alone. To detect geriatric conditions in safety net populations, the Age-Friendly Health System (AFHS) framework offers an evidence-based focus on the 4Ms: Mentation, Mobility, Medications, and what Matters. Further incorporating geriatric care models that target the 4Ms and are adapted to safety net populations will enable age-friendly care that optimizes health and addresses what matters to older people.

BackgroundOlder adults often take multiple medications, leading to a myriad of medication-related problems. Addressing these problems requires thoughtful approaches that align with patients' perspectives and experiences.ObjectiveTo (1) identify and categorize medication-related problems from the patient perspective and (2) understand patient and clinician attitudes toward these problems and experiences with addressing these problems.DesignQualitative, semi-structured interviews with patients and focus groups with physicians and pharmacists.ParticipantsTwenty older adults recruited from an academic medical center and from a community senior center; 14 primary care physicians and 6 pharmacists affiliated with an academic medical center.ApproachHybrid deductive-inductive thematic analysis.Key resultsOlder adults identified a variety of medication-related problems that could be classified into four broad categories: (1) obtaining medications (e.g., problems with cost and insurance coverage); (2) taking medications (e.g., organization and remembering to take pills); (3) medication effects, including side effects and concerns over lack of effectiveness; and (4) communication and care coordination, including information related to medications. Many of the problems described by older adults were framed within the person's socioemotional context, including the impact of medications on interpersonal relationships, emotional wellbeing, and activities that add meaning and quality to life. In contrast, clinicians almost exclusively focused on discrete medication issues without reference to this larger context and expressed relatively little interest in learning more about their patients' perspectives.ConclusionsOlder adults experience medication-related problems as inseparable from their broader life context. Incorporating the social and emotional context of medications and related communication into a problem-focused framework can guide clinicians in specific actions and interventions to address medication-related problems from the patient perspective.

BackgroundKnowledge about expected recovery after hip fracture is essential to help patients and families set realistic expectations and plan for the future.ObjectivesTo determine rates of functional recovery in older adults who sustained a hip fracture based on one's previous function.DesignObservational study.ParticipantsWe identified subjects who sustained a hip fracture while enrolled in the nationally representative Health and Retirement Study (HRS) using linked Medicare claims. HRS interviews subjects every 2 years. Using information from interviews collected during the interview preceding the fracture and the first interview 6 or more months after the fracture, we determined the proportion of subjects who returned to pre-fracture function.Main measuresFunctional outcomes of interest were: (1) ADL dependency, (2) mobility, and (3) stair-climbing ability. We examined baseline characteristics associated with a return to: (1) ADL independence, (2) walking one block, and (3) climbing a flight of stairs.Key resultsA total of 733 HRS subjects ≥65 years of age sustained a hip fracture (mean age 84 ± 7 years, 77 % female). Thirty-one percent returned to pre-fracture ADL function, 34 % to pre-fracture mobility function, and 41 % to pre-fracture climbing function. Among those who were ADL independent prior to fracture, 36 % returned to independence, 27 % survived but needed ADL assistance, and 37 % died. Return to ADL independence was less likely for those ≥85 years old (26 % vs. 44 %), with dementia (8 % vs. 39 %), and with a Charlson comorbidity score >2 (23 % vs. 44 %). Results were similar for those able to walk a block and for those able to climb a flight of stairs prior to fracture.ConclusionsRecovery rates are low, even among those with higher levels of pre-fracture functional status, and are worse for patients who are older, cognitively impaired, and who have multiple comorbidities.