Three physicians, all women, each perceived serious unmet needs in their fields, and envisioned imaginative approaches to meeting those needs. Each encountered resistance, discouragement, and obstruction from the traditional, male-dominated departments in which they worked. These powerful pioneers, undeterred, created programs that earned the highest levels of national distinction and acclaim. Their work and their names are now legendary—in geriatric medicine, in the treatment of breast cancer, and in diabetes research and treatment. Their stories differ, but the commonalities help us understand why constructive change is often so hard-won, and what it takes in commitment, courage, and tenacity to triumph in the end. Sharon Brangman, Patricia Numann, and Ruth Weinstock are inspiring heroes, from whom we can all learn essential lessons.
Importance There are limited efficacious treatments for Alzheimer disease. Objective To assess efficacy and adverse events of donanemab, an antibody designed to clear brain amyloid plaque. Design, Setting, and Participants Multicenter (277 medical research centers/hospitals in 8 countries), randomized, double-blind, placebo-controlled, 18-month phase 3 trial that enrolled 1736 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology based on positron emission tomography imaging from June 2020 to November 2021 (last patient visit for primary outcome in April 2023). Interventions Participants were randomized in a 1:1 ratio to receive donanemab (n = 860) or placebo (n = 876) intravenously every 4 weeks for 72 weeks. Participants in the donanemab group were switched to receive placebo in a blinded manner if dose completion criteria were met. Main Outcomes and Measures The primary outcome was change in integrated Alzheimer Disease Rating Scale (iADRS) score from baseline to 76 weeks (range, 0-144; lower scores indicate greater impairment). There were 24 gated outcomes (primary, secondary, and exploratory), including the secondary outcome of change in the sum of boxes of the Clinical Dementia Rating Scale (CDR-SB) score (range, 0-18; higher scores indicate greater impairment). Statistical testing allocated α of .04 to testing low/medium tau population outcomes, with the remainder (.01) for combined population outcomes. Results Among 1736 randomized participants (mean age, 73.0 years; 996 [57.4%] women; 1182 [68.1%] with low/medium tau pathology and 552 [31.8%] with high tau pathology), 1320 (76%) completed the trial. Of the 24 gated outcomes, 23 were statistically significant. The least-squares mean (LSM) change in iADRS score at 76 weeks was −6.02 (95% CI, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25 [95% CI, 1.88-4.62]; P < .001) in the low/medium tau population and −10.2 (95% CI, −11.22 to −9.16) with donanemab and −13.1 (95% CI, −14.10 to −12.13) with placebo (difference, 2.92 [95% CI, 1.51-4.33]; P < .001) in the combined population. LSM change in CDR-SB score at 76 weeks was 1.20 (95% CI, 1.00-1.41) with donanemab and 1.88 (95% CI, 1.68-2.08) with placebo (difference, −0.67 [95% CI, −0.95 to −0.40]; P < .001) in the low/medium tau population and 1.72 (95% CI, 1.53-1.91) with donanemab and 2.42 (95% CI, 2.24-2.60) with placebo (difference, −0.7 [95% CI, −0.95 to −0.45]; P < .001) in the combined population. Amyloid-related imaging abnormalities of edema or effusion occurred in 205 participants (24.0%; 52 symptomatic) in the donanemab group and 18 (2.1%; 0 symptomatic during study) in the placebo group and infusion-related reactions occurred in 74 participants (8.7%) with donanemab and 4 (0.5%) with placebo. Three deaths in the donanemab group and 1 in the placebo group were considered treatment related. Conclusions and Relevance Among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab significantly slowed clinical progression at 76 weeks in those with low/medium tau and in the combined low/medium and high tau pathology population. Trial Registration ClinicalTrials.gov Identifier: NCT04437511
Abstract Background Racial and ethnic underrepresentation in aging research and need for effective recruitment strategies is well documented. A Community Research Liaison (CRL) role created under a NIA award is demonstrating the value of embedding staff from underrepresented communities in the research infrastructure. Methods The role and qualifications for a CRL were developed with individuals from an African American community. The CRL hired from this community is engaging in outreach to understand barriers to and discuss the value of research with community members. Through the CRL, community input is being translated into changes in recruitment methods that reflect the concerns, interests and needs of potential African American participants. This case study reports on recruitment outcomes for a study on markers of cognitive decline in older adults requiring 2 hours in an MRI, 5 for testing, and 3 for travel. Recruitment data are compared 6 months before and 3 months after the CRL was engaged. Result In the 6 months prior to the CRL’s involvement, 309 individuals passed an initial screening and 156 were found potentially eligible after a second screening. Five (3.2%) of the 156 were African American. Of these, one was found ineligible, one was lost to follow‐up and the 3 participated in the study. In the first 3 months after the CRL was engaged, 35 were referred to the study after recruitment by the CRL. All were African American, 15 (43%) were eligible and enrolled, 9 (26%) were ineligible, and 9 (26%) are still in the screening process. Conclusion The case study demonstrates the promise of a CRL who is a member of an African American community in increasing African American participation in research. The CRL dramatically increased the number of older African Americans recruited despite potential participation barriers. The increase was due in large part to the CRL’s understanding of and recognition as a trusted member of the community and to changes she recommended to promotional materials and logistics based on community feedback. Data on recruitment effectiveness are continuing to be evaluated across a range of aging research studies and clinical trials in which the CRL is engaged.
Strategies to reduce the documented disparities in health and health care for the rapidly growing numbers of older patients from diverse ethnic populations include increased cultural competence of providers. To assist geriatric faculty in medical and other health professional schools develop cultural competence training for their ethnogeriatric programs, the University of California Academic Geriatric Resource Program partnered with the Ethnogeriatric Committee of the American Geriatrics Society to develop a curricular framework. The framework includes core competencies based on the format of the Core Competencies for the Care of Older Patients developed by the Education Committee of the American Geriatrics Society. Competencies in attitudes, knowledge, and skills for medical providers caring for elders from diverse populations are specified. Also included are recommended teaching strategies and resources for faculty to pursue the development of full curricula.
While we currently cannot cure Alzheimer’s disease or change the course of the disease, there are advantages to early detection. Routine, evidence based, brief cognitive screens offer destigmatized opportunities for diagnosis and improve the possibility of early identification of cognitive impairment. This community-based participatory research project evaluated the use of the Mini-Cog™ instrument to detect cognitive impairment in vulnerable community-dwelling older adults when administered by trained social services providers. Over 9 months, a case manager screened 69 clients ages 65 to 94 (mean 74.67) who met inclusion criteria for the pilot; 84.1% were female, 53.6% were Black, 26% were living with undetected cognitive impairment. Although participants agreed to Mini-Cog™ screening, two-thirds with Mini-Cog™ scores indicating cognitive impairment refused referrals for further evaluation. Future interventions should reduce stigma by educating the public about dementia and engaging members of racial and cultural communities in outreach.
Polypharmacy increases risk of adverse drug effects.
Objective:
To retrospectively determine whether a pragmatic deprescribing protocol reduced 8 common classes of medications in two skilled nursing facilities (SNFs) in a single system.
Study Design and Analysis:
Retrospective, longitudinal pre/post evaluation. A preliminary analysis was published using data from 2017-first half of 2021. This follow up examines whether initial improvements were maintained over a longer evaluation interval, comparing the pre (2017-2019) with post-intervention years (2020-2021).
Setting or Dataset:
Long-term resident data reported through annual comprehensive minimum data set (MDS) reviews conducted at two skilled nursing facilities in a single system.
Population Studied:
Long-term residents at two skilled nursing facilities.
Intervention/Instrument:
Interdisciplinary deprescribing effort to reduce medication in SNF residents including clinician education, guideline development, and chart reviews.
Outcome Measures:
Odds of being administered each of 8 classes of medication (Diuretic, Opioid, Antipsychotic, Anticoagulant, Antianxiety, Antibiotic, Hypnotic, Antidepressant, and average total classes of medications (0-8) per record. Odds Ratios for each class of medication, and mean number of medication classes, were compared between the first and updated analyses. Each analysis controlled for race, female gender, and age.
Results:
There were 15,117 resident data points available for analysis. The mean total medications per resident slightly decreased in the post-intervention period (mean=1.85 classes of medication per resident at both facilities from 2020-2021 vs 1.88 from 2017-2019). Significant decreases in ORs were maintained for Diuretic (.846, p<.001 vs .82 p<.001), Opioid (.740, p<.001 vs .79 p<.001), and Antipsychotic (.848, p<.001 vs .80 p=.006) administration; a decrease in odds of being administered an antibiotic became significant (.888, p<.004 vs .98 p= .711). A nonsignificant decrease in the odds of Antianxiety drug administration was also maintained (.932, p=.187 vs .89 p=.138).
Conclusions:
Reductions were maintained for medication classes with serious side effects). These results are convergently supported by a separate cost-effectiveness analysis.
Polypharmacy, referring to multiple medications or the use of more drugs than are medically necessary, may lead to undesirable consequences, increasing the risk of adverse drug effects and leading to increases in falls and hospitalizations among older persons. Our objective was to retrospectively determine whether a pragmatic deprescribing protocol reduced 8 common classes of medications in two skilled nursing facilities (SNFs) in a single system.
Objective:
To determine whether a deprescribing effort reduced several key classes of medications, and the overall number of medication classes per patient, among long-term residents of SNFs.
Study Design and Analysis:
Retrospective, longitudinal pre/post evaluation. Data from before and during the implementation of the deprescribing effort (2018-2019) were compared with post-intervention years (2020-2021).
Setting and Populations Studied:
Long-term resident data reported through annual comprehensive minimum data set (MDS) reviews conducted at two SNFs located in central New York State between 2018 and 2021 (N=11,862).
Intervention/Instrument:
Multi-faceted, pragmatic interdisciplinary deprescribing effort to reduce medications in SNF residence including clinician education, guideline development, and individual chart reviews began in 2019.
Outcome Measures:
Overall percentage of patients on each of eight classes of medications, compare between pre- and post- intervention periods via cross-tabulation with chi-square. Mean total medication classes for each patient compared pre/post via one-way Analysis of Variance (ANOVA).
Results:
Mean number of medications were lower, post-intervention, at both facilities (mean=1.88 pre vs. 1.85 post, NS). Significant drops were observed in 4 of 8 categories, including Diuretics (-3.7%, p=.001), Opioids (-4.9%, p=.001), Antipsychotics (-2.0%, p=.002), Antibiotics (-1.6%, p=.045). Antianxiety medications were non-significantly reduced by 0.5%. Antidepressant usage increased (4.6%, p<.001), as did Anticoagulants (4.4%, p<.001). Hypnotic usage went up slightly, but was rare in both periods (0.9% pre vs. 1.4% post, p=.004), and represents a real difference of 3 patients in total.
Conclusions:
A combined, comprehensive approach to deprescribing was associated with a reduction in overall number of medication classes per resident and in several key classes of medications. Antidepressant usage likely increased as a safer offset to reductions in higher risk medications.
Las minorias de ancianos en los Estados Unidos tendran un crecimiento acelerado en las proximas decadas. Incluyen ancianos de grupos etnicos heterogeneos como negros, hispanos, asiaticos e indigenas americanos. El Comite de Etnogeriatria de la Sociedad Americana de Geriatria, SAG, trabaja en aspectos relacionados con la salud y el bienestar de tales minorias. Se informa la Declaracion de Posicion en Etnogeriatria de la SAG. La SAG promueve la sensibilidad multicultural, la educacion y la investigacion interdisciplinaria sobre los factores etnicos que afectan el envejecimiento, la salud y la aparicion de enfermedades en las personas mayores. Las minorias de ancianos tienen una alta prevalencia de cuadros clinicos patologicos en edades tempranas que afectan la funcionalidad y calidad de vida de estas personas. Tambien hay barreras linguisticas o culturales, pobreza, y bajo nivel educativo que disminuyen el acceso al cuidado de la salud. La SAG apoya conocer y superar esos factores que influyen sobre la salud de las minorias de ancianos en America.
