[The exclusion of older patients from clinical trials regarding heart failure. Causes and consequences]. / L'esclusione degli anziani dai trial clinici sullo scompenso cardiaco: cause e conseguenze.

Older subjects are commonly excluded from clinical trials, that are the gold standard to assess the efficacy and safety of new drugs and non pharmacological therapies. The consequence is the lack of evidence about the optimal drug therapy in this population, who makes the highest consumption of drugs, with increased risk of adverse reactions and undertreatment. A clear example is heart failure: data obtained in the context of the European Project PREDICT confirm a widespread exclusion of older individuals from ongoing clinical trials in heart failure, despite the recommendations of regulatory agencies.

Predictors of Functional Decline in Nursing Home Residents: The Shelter Project.

BACKGROUND: The aim of our study was to identify independent predictors of functional decline in older nursing home (NH) residents, taking into account both resident and facility characteristics. METHODS: Longitudinal observational study involving 1,760 older (≥65 y) residents of NH participating in the SHELTER* study (57 NH in eight countries). All residents underwent a comprehensive geriatric assessment using the interRAI LTCF. Functional decline was defined as an increase of at least one point in the MDS Long Form ADL scale during a 1 year follow-up. Facility and country effects were taken into account. RESULTS: During the study period 891 (50.6%), NH residents experienced ADL decline. Residents experiencing ADL decline were older, had lower disability at baseline, were more frequently affected by severe dementia and by urinary incontinence, and used more antipsychotics. In the mixed-effect logistic regression model, factors independently associated with a higher risk of functional decline were dementia and urinary incontinence, whereas the presence of a geriatrician was a protective factor. CONCLUSIONS: Both resident and facility characteristics are associated with the risk of functional decline in NH residents. Increasing the quality of healthcare by involving a geriatrician in residents' care might be an important strategy to improve the outcome of this vulnerable population.

Effects of Weekly Supplementation of Cholecalciferol and Calcifediol Among the Oldest-Old People: Findings From a Randomized Pragmatic Clinical Trial.

Vitamin D inadequacy is pervasive in the oldest-old. Many vitamin D metabolites are available for supplementation, their effects on the recovery of adequate serum levels remain unknown. We investigate the effects of supplementation with cholecalciferol (D3) and calcifediol (25D3) on serum levels of 25(OH)D, 1-25(OH)D, bone and inflammatory markers, ultimately identifying clinical predictors of successful treatment. Sixty-seven oldest-old individuals were randomized to weekly administration of 150 mcg of 25D3 or D3, from hospital admission to 7 months after discharge. Supplementation of 25D3 and D3 were associated with increasing serum levels of 25(OH)D (p < 0.001) and 1-25(OH)D (p = 0.01). Participants on 25D3 experienced a steeper rise than those on D3 (group*time interaction p = 0.01), after adjustment for intact parathyroid hormone (iPTH) levels the differences disappeared (intervention*iPTH interaction p = 0.04). Vitamin D supplementation was associated with a decreasing trend of iPTH and C-reactive protein (CRP) (p < 0.001). Polypharmacy and low handgrip strength were predictors of failure of intervention, independent of vitamin D metabolites. In conclusion, D3 and 25D3 supplementation significantly increase vitamin D serum levels in the oldest-old individuals, with a tendency of 25D3 to show a faster recovery of acceptable iPTH levels than D3. Polypharmacy and low muscle strength weaken the recovery of adequate vitamin D serum levels.

Prognosis and Interplay of Cognitive Impairment and Sarcopenia in Older Adults Discharged from Acute Care Hospitals.

Sarcopenia and cognitive impairment are associated with an increased risk of negative outcomes, but their prognostic interplay has not been investigated so far. We aimed to investigate the prognostic interaction of sarcopenia and cognitive impairment concerning 12-month mortality among older patients discharged from acute care wards in Italy. Our series consisted of 624 patients (age = 80.1 ± 7.0 years, 56.1% women) enrolled in a prospective observational study. Sarcopenia was defined following the European Working Group on Sarcopenia in Older People (EWGSOP) criteria. Cognitive impairment was defined as age- and education-adjusted Mini-Mental State Examination (MMSE) score < 24 or recorded diagnosis of dementia. The study outcome was all-cause mortality during 12-month follow-up. The combination of sarcopenia and cognitive ability was tested against participants with intact cognitive ability and without sarcopenia. Overall, 159 patients (25.5%) were identified as having sarcopenia, and 323 (51.8%) were cognitively impaired. During the follow-up, 79 patients (12.7%) died. After adjusting for potential confounders, the combination of sarcopenia and cognitive impairment has been found associated with increased mortality (HR = 2.12, 95% CI = 1.05-4.13). Such association was also confirmed after excluding patients with dementia (HR = 2.13, 95% CI = 1.06-4.17), underweight (HR = 2.18, 95% CI = 1.03-3.91), high comorbidity burden (HR = 2.63, 95% CI = 1.09-6.32), and severe disability (HR = 2.88, 95% CI = 1.10-5.73). The co-occurrence of sarcopenia and cognitive impairment may predict 1-year mortality in older patients discharged from acute care hospitals.

Lack of Energy and Negative Health-Related Outcomes in Nursing Home Residents: Results From the INCUR Study.

OBJECTIVE: "Lack of energy" or anergia is a common complaint associated with adverse outcomes in older people. There is a lack of knowledge on this symptom in the nursing home (NH) setting. The aim of this study was to investigate whether lack of energy was associated with hospitalization and mortality in NH residents. DESIGN: Longitudinal observational cohort study. SETTING AND PARTICIPANTS: A total of 575 NH residents (72% women) in 13 French NHs from the Incidence of pNeumonia and related ConseqUences in nursing home Residents (INCUR) study cohort. MEASUREMENTS: Lack of energy was measured at the baseline visit as part of the 10-item Geriatric Depression Scale. Unadjusted and adjusted Cox proportional hazard regression models were performed to test the association of lack of energy with hospitalization events and mortality over 12 months of follow-up. RESULTS: The mean age of the study sample was 86.3 (SD = 7.5) years. At the baseline, 250 (43.5%) residents complained about lack of energy. Overall, 192 (33.4%) individuals experienced at least 1 hospitalization event and 98 (17.0%) died during the 12-month follow-up. Lack of energy was significantly associated with a higher risk of hospitalization (HR 1.35; 95% CI 1.02-1.80; P = .03), even after adjustment for potential confounders (HR 1.41; 95% CI 1.04-1.91; P = .02). No statistically significant association was found between lack of energy and 12-month mortality. CONCLUSION: Lack of energy is a predictor of hospitalization in older people living in NHs. It may be considered a relevant clinical feature for identifying individuals at risk of adverse health outcomes, thus potentially serving as a screening tool for subsequently conducting a comprehensive geriatric assessment in this highly vulnerable and complex population.

Fatigue: Relevance and implications in the aging population.

Frailty has been identified as a promising condition for distinguishing different degrees of vulnerability among older persons. Several operational definitions have proposed fatigue as one of the features characterizing the frailty syndrome. However, such a subjective symptom is still not yet sufficiently explored and understood. Fatigue is a common and distressing self-reported symptom perceived by the person while performing usual mental and physical activities, highly prevalent in older people, and strongly associated with negative health-related events. The understanding of fatigue is hampered by several issues, including the difficulty at objectively operationalizing, the controversial estimates of its prevalence, and the complex pathophysiological mechanisms underlying its manifestation. Despite such barriers, the study of fatigue is important and might be encouraged. Fatigue may be the marker of the depletion of the body's homeostatic reserves to a threshold leading to its psycho-physical functional impairment, mirroring the concept of frailty. Its subjective and symptomatic nature resembles that of other conditions (e.g., pain, depression), which equally affect the individual's quality of life, expose to negative outcomes, and severely burden healthcare expenditures. In the present paper, we present an overview of the current knowledge on fatigue in older persons in order to increase awareness about its clinical and research relevance. Future research on this topic should be encouraged and developed because it could potentially lead to novel interventions against this symptom as well as against frailty and age-related conditions.

Fracture prevention service to bridge the osteoporosis care gap.

BACKGROUND: A care gap exists between the health care needs of older persons with fragility fractures and the therapeutic answers they receive. The Fracture Prevention Service (FPS), a tailored in-hospital model of care, may effectively bridge the osteoporosis care gap for hip-fractured older persons. The purpose of this study was to evaluate the efficacy of the FPS in targeting persons at high risk of future fracture and to improve their adherence to treatment. METHODS: This was a prospective observational study conducted in a teaching hospital with traumatology and geriatric units, and had a pre-intervention and post-intervention phase. The records of 172 participants were evaluated in the pre-intervention phase, while data from 210 participants were gathered in the post-intervention phase. All participants underwent telephone follow-up at 12 months after hospital discharge. The participants were patients aged ≥65 years admitted to the orthopedic acute ward who underwent surgical repair of a proximal femoral fracture. A multidisciplinary integrated model of care was established. Dedicated pathways were implemented in clinical practice to optimize the identification of high-risk persons, improve their evaluation through bone mineral density testing and blood examinations, and initiate an appropriate treatment for secondary prevention of falls and fragility fractures. RESULTS: Compared with the pre-intervention phase, more hip-fractured persons received bone mineral density testing (47.62% versus 14.53%, P<0.0001), specific pharmacological treatments (48.51% versus 17.16%, P<0.0001), and an appointment for evaluation at a fall and fracture clinic (52.48% versus 2.37%, P<0.0001) in the post-intervention phase. Independent of some confounders, implementation of the FPS was positively associated with recommendations for secondary fracture prevention at discharge (P<0.0001) and with 1-year adherence to pharmacological treatment (P<0.0001). CONCLUSION: The FPS is an effective multidisciplinary integrated model of care to optimize identification of older persons at highest risk for fragility fracture, to improve their clinical management, and to increase adherence to prescriptions.

Underrecognition and undertreatment of dementia in Italian nursing homes.

OBJECTIVE: To determine the prevalence of dementia diagnoses and the use of antidementia drugs in a cohort of Italian older nursing home (NH) residents. DESIGN: Cross-sectional study. SETTING: The NH residents participating in 2 studies: the U.L.I.S.S.E. study and the Umbria Region survey. PARTICIPANTS: A total of 2215 nursing home residents. MEASUREMENT: Each resident underwent a comprehensive geriatric assessment at baseline by means of the RAI MDS 2.0. Dementia diagnosis was based on ICD-9 codes. RESULTS: The prevalence of dementia diagnosis according to ICD-9 codes was 50.7% (n = 1123), whereas 312 subjects had cognitive impairment with a cognitive performance scale score ≥3 without a diagnosis of dementia. Only 56 NH residents were treated (5% of the sample) and the main drugs used were cholinesterase inhibitor, whereas only 1 subject was treated with memantine. Limiting our analysis to patients with mild to moderate Alzheimer's disease, who are those reimbursed by the public health care system for receiving antidementia drugs, the percentage rose to 11.3%. CONCLUSION: These findings demonstrate a high rate of underdiagnosis and undertreatment of dementia in Italian NH residents. Potential explanations include the lack of systematic assessment of cognitive functions, the limitations to antidementia drug reimbursement, the complexity of the reimbursement procedure itself, and the high prevalence of patients with severe dementia. Older NH residents still lack proper access to state-of-the-art diagnosis and treatment for a devastating condition such as dementia.

The prevention of adverse drug reactions in older subjects.

Adverse drug reactions (ADRs) are a public health problem in older subjects, being responsible for a significant morbidity, disability and mortality. Older subjects are more susceptible to develop ADRs mainly due to polypharmacy, multimorbidity and inappropriate prescribing. The prevention of these drug related negative events represents an important aim for physicians treating older patients. Several strategies could potentially be employed, including state of the art education of medical students and physicians concerning principles of geriatric medicine and appropriate prescription in older subjects, reduction of inappropriate drug use by means of computerized decision support systems, pharmacist involvement and comprehensive geriatric assessment, and finally the identification of at risk older patients. However, there is currently a lack of scientific evidence demonstrating that these strategies can achieve a reduction in ADRs and therefore future intervention studies should be performed to evaluate the best intervention to decrease the burden of drug related problems in the older population.