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Changes in the Use of Comprehensive Geriatric Assessment in Clinical Trials for Older Patients with Cancer over Time.
Le Saux, O, Falandry, C, Gan, HK, You, B, Freyer, G, Péron, J
The oncologist. 2019;(8):1089-1094
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Abstract
BACKGROUND The objective of this study was to describe the implementation of comprehensive geriatric assessment (CGA) in clinical trials dedicated to older patients before and after the creation of the International Society of Geriatric Oncology in the early 2000s. SUBJECTS, MATERIALS, AND METHODS All phase I, II, and III trials dedicated to the treatment of cancer among older patients published between 2001 and 2004 and between 2011 and 2014 were reviewed. We considered that a CGA was performed when the authors indicated an intention to do so in the Methods section of the article. We collected each geriatric domain assessed using a validated tool even in the absence of a clear CGA, including nutritional, functional, cognitive, and psychological status, comorbidity, comedication, overmedication, social status and support, and geriatric syndromes. RESULTS A total of 260 clinical trials dedicated to older patients were identified over the two time periods: 27 phase I, 193 phase II, and 40 phase III trials. CGA was used in 9% and 8% of phase II and III trials, respectively; it was never used in phase I trials. Performance status was reported in 67%, 79%, and 75% of phase I, II, and III trials, respectively. Functional assessment was reported in 4%, 11%, and 13% of phase I, II, and III trials, respectively. Between the two time periods, use of CGA increased from 1% to 11% (p = .0051) and assessment of functional status increased from 3% to 14% (p = .0094). CONCLUSION The use of CGA in trials dedicated to older patients increased significantly but remained insufficient. IMPLICATIONS FOR PRACTICE This article identifies the areas in which research efforts should be focused in order to offer physicians well-addressed clinical trials with results that can be extrapolated to daily practice.
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Adherence of older emergency department patients to community-based specialized geriatric services.
MacDonald, Z, Stiell, IG, Genovezos, I, Eagles, D
CJEM. 2019;(5):659-666
Abstract
OBJECTIVES Our objective was to determine emergency department (ED) patient adherence to outpatient specialized geriatric services (SGS) following ED evaluation by the geriatric emergency management (GEM) nurse, and identify barriers and facilitators to attendance. METHODS We conducted a prospective cohort study at two academic EDs between July and December 2016, enrolling a convenience sample of patients ≥ 65 years, seen by a GEM nurse, referred to outpatient SGS, and consented to study participation. We completed a chart review and a structured telephone follow-up at 6 weeks. Descriptive statistics were used. RESULTS We enrolled 103/285 eligible patients (86 eligible but not enrolled, 86 declined specialized geriatric referrals, and 10 declined study participation). Patients were mean age of 83.1 years, 59.2% female, and 73.2% cognitively impaired. Reasons for referral included mobility (86.4%), cognition (56.3%), pain (38.8%), mood (35.0%), medications (33.0%), and nutrition (31.1%). Referrals were to Geriatric Day Hospital (GDH) programs (50.5%), geriatric outreach (26.2%), falls clinic (12.6%), and geriatric psychiatry (8.7%). Adherence with follow-up was 59.2%. Barriers to attendance included patient did not feel SGS were needed (52.1%), inability to recall GEM consultation (53.4%), and dependence on family for transportation (72.6%). Home-based assessments had the highest adherence (81.5%). CONCLUSION Adherence of older ED patients referred by the GEM team to SGS is suboptimal, and a large proportion of patients decline these referrals in the ED. Future work should examine the efficacy of home-based assessments in a larger confirmatory setting and focus on interventions to increase referral acceptance and address barriers to attendance.
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The performance of three oncogeriatric screening tools - G8, optimised G8 and CARG - in predicting chemotherapy-related toxicity in older patients with cancer. A prospective clinical study.
Kotzerke, D, Moritz, F, Mantovani, L, Hambsch, P, Hering, K, Kuhnt, T, Yahiaoui-Doktor, M, Forstmeyer, D, Lordick, F, Knödler, M
Journal of geriatric oncology. 2019;(6):937-943
Abstract
BACKGROUND Older patients are vulnerable to chemotherapy-related toxicity (CRT). Therefore we evaluated screening tools in their power to predict CRT. METHODS Patients with cancer aged ≥65 years completed three screening questionnaires (G8, optimised G8 and Cancer and Ageing Research Group (CARG). Additionally, Comprehensive geriatric assessment (CGA) for verification of supportive care needs was undertaken on patients with impaired G8 scores. During chemotherapy treatment patients were assessed, capturing grade 0-5 CRT as defined by NCI CTCAE 4. RESULTS 104 patients with non-haematological cancers were included at three study sites. Median age was 73 years (range 65-85). Onco-geriatric screening detected 74% as impaired using G8 and optimised G8 questionnaires and 86% using CARG screening. Grade 3-5 toxicity affected 64.4% of all patients. G8 (OR 0.3 95% CI [0.1;1.0]) and optimised G8 (OR 0.4 95% CI [0.1; 1.5]) did not reliably predict CRT, whereas screening with CARG demonstrated a strong prediction of severe CRT: OR 4.2, 95% CI [1.1, 15.9]. CGA was undertaken on 66 patients, revealing deficiencies in nutritional (83%) and functional-status (54%) and occurrence of relevant comorbidity (53%). CONCLUSION The CARG tool could be useful for predicting CRT. CGA showed clinically relevant supportive care needs in patients with a positive G8 screening.
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Higher Fit-fOR-The-Aged (FORTA) Scores Comprising Medication Errors are Associated with Impaired Cognitive and Physical Function Tests in the VALFORTA Trial.
Pazan, F, Burkhardt, H, Frohnhofen, H, Weiss, C, Throm, C, Kuhn-Thiel, A, Wehling, M
Drugs & aging. 2019;(3):269-277
Abstract
BACKGROUND The Fit fOR The Aged (FORTA) list, a drug classification combining positive and negative labelling of drugs, has been clinically (VALFORTA-trial) validated to improve medication quality and clinical endpoints. OBJECTIVE The objective of this study was to determine the association of medication quality with functional abilities tested in cognitive and physical function tests. PATIENTS AND METHODS Data from the prospective, randomized controlled VALFORTA trial on 409 geriatric (mean age 81.53 years) in-hospital patients were tested for associations between the FORTA score (sum of over- and under-treatment errors) on admission and cognitive and physical function tests. Univariate and multivariate linear correlations corrected for age, sex, number of medications, number of chronic conditions, and body mass index as well as comparisons between high and low FORTA-score (cut-off 3) patients were performed. RESULTS The FORTA score was significantly correlated with Instrumental Activities of Daily Living (p < 0.0001), the Tinetti test (p < 0.002), Essen Questionnaire on Age and Sleepiness (p < 0.0001), Mini-Mental State Examination (p < 0.0001), and handgrip strength (p < 0.04) in the univariate analysis, and with Instrumental Activities of Daily Living (p < 0.003), the Tinetti test (p < 0.003), and the Essen Questionnaire on Age and Sleepiness (p < 0.0001) in the multivariate analysis. Effect size was weak for Instrumental Activities of Daily Living (R-squared = 0.12) and the Tinetti test (R-squared = 0.03) and medium for the Essen Questionnaire on Age and Sleepiness (R-squared = 0.22). Significant differences between patients with high and low FORTA scores were found for Instrumental Activities of Daily Living, the Tinetti test, mini-nutritional assessments, Mini-Mental State Examination, Essen Questionnaire on Age and Sleepiness, and the Geriatric Depression Scale. All significant tests revealed that higher FORTA scores (lower medication quality) were associated with less favorable test outcomes. CONCLUSIONS The FORTA score is associated with relevant aspects of comprehensive geriatric assessment, underlining the importance of medication quality for the functional and cognitive well-being of older patients. TRIAL REGISTRATION NUMBER DRKS00000531.
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Geriatric Nutritional Risk Index Predicts Adverse Outcomes in Human Malignancy: A Meta-Analysis.
Lv, GY, An, L, Sun, DW
Disease markers. 2019;:4796598
Abstract
BACKGROUND Geriatric Nutritional Risk Index (GNRI) has been widely used to assess the nutritional status in a variety of human pathological conditions, but the prognostic value of the GNRI in malignancies has not been evinced. METHODS Relevant studies updated on Jul 27, 2019, were retrieved in available databases, including PubMed, Web of Science, Cochrane library, Chinese CNKI, and Chinese Wan-fang. Hazard ratios (HRs) and 95% confidence intervals (CIs) were extracted and pooled by using STATA 14. RESULTS A total of 15 studies involving 8,046 subjects were included in this meta-analysis. Meta-analysis results evinced that low GNRI was associated with poor OS (HR = 1.95, 95% CI: 1.49-2.56, p ≤ 0.001), poor CSS (HR = 1.81, 95% CI: 1.49-2.19, p ≤ 0.001), poor DFS (HR = 1.67, 95% CI: 1.28-2.17, p ≤ 0.001), and poor PFS (HR = 1.68, 95% CI: 1.28-2.21, p ≤ 0.001), and the correlation of GNRI with OS was not changed when stratified by possible confounding factors, suggesting that malignancy patients with low GNRI would suffer from reduced survival rate and increased recurrence rate. Moreover, low GNRI was also associated with postoperative complications in malignancies. CONCLUSIONS In summary, GNRI is associated poor prognosis in human malignancies, and GNRI should be used as a predictive indicator of adverse outcomes during malignancy treatment.
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Predictive Effect of Malnutrition on Long-Term Clinical Outcomes among Older Men: A Prospectively Observational Cohort Study.
Hsu, YH, Chou, MY, Chu, CS, Liao, MC, Wang, YC, Lin, YT, Chen, LK, Liang, CK
The journal of nutrition, health & aging. 2019;(9):876-882
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Abstract
OBJECTIVES To determine whether nutritional status can predict 3-year cognitive and functional decline, as well as 4-year all-cause mortality in older adults. DESIGN Prospectively longitudinal cohort study. SETTING AND PARTICIPANTS The study recruited 354 men aged 65 years and older in the veteran's retirement community. MEASURES Baseline nutritional status was evaluated using the Mini-Nutritional Assessment-Short Form (MNA-SF). Cognitive function and Activities of Daily Living (ADL) function were determined by the Mini-Mental State Examination (MMSE) and the Barthel Index, respectively. Three-year cognitive and functional decline were respectively defined as a >3 point decrease in the MMSE scores and lower ADL scores than at baseline. Univariate and multivariable logistic regression analyses were conducted to identify nutritional status as a risk factor in poor outcome. The Kaplan-Meier method and Cox proportional regression models were used to estimate the effect of malnutrition risk on the mortality. RESULTS According to MNS-SF, the prevalence of risk of malnutrition was 53.1% (188/354). Multivariate logistic regression found risk of malnutrition significantly associated with 3-year cognitive decline (Adjusted odds ratio [OR] 2.07, 95% Confidence Interval [CI] 1.05-4.08, P =0.036) and functional decline (Adjusted OR 1.83, 95% CI 1.01-3.34, P =0.047) compared with normal nutritional status. The hazard ratio (HR) for all-cause mortality was 1.8 times higher in residents at risk of malnutrition (Adjusted HR 1.82, 95% CI 1.19-2.79, P =0.006). CONCLUSIONS Our results provide strong evidence that risk of malnutrition can predict not only cognitive and functional decline but also risk of all-cause mortality in older men living in a veteran retirement's community. Further longitudinal studies are needed to explore the causal relationship among nutrition, clinical outcomes, and the effect of an intervention for malnutrition.
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Impact of 3-week citrulline supplementation on postprandial protein metabolism in malnourished older patients: The Ciproage randomized controlled trial.
Bouillanne, O, Melchior, JC, Faure, C, Paul, M, Canouï-Poitrine, F, Boirie, Y, Chevenne, D, Forasassi, C, Guery, E, Herbaud, S, et al
Clinical nutrition (Edinburgh, Scotland). 2019;(2):564-574
Abstract
BACKGROUND Citrulline (CIT), is not extracted by the splanchnic area, can stimulate muscle protein synthesis and could potentially find clinical applications in conditions involving low amino acid (AA) intake, such as in malnourished older subjects. OBJECTIVE Our purpose was to research the effects of CIT supplementation on protein metabolism in particular on non-oxidative leucine disposal (NOLD, primary endpoint), and splanchnic extraction of amino acids in malnourished older patients. DESIGN This prospective randomized multicenter study determined whole-body and liver protein synthesis, splanchnic protein metabolism and appendicular skeletal muscle mass (ASMM) in 24 malnourished older patients [80-92 years; 18 women and 6 men] in inpatient rehabilitation units. All received an oral dose of 10 g of CIT or an equimolar mixture of six non-essential amino acids (NEAAs), as isonitrogenous placebo, for 3 weeks. RESULTS NOLD and albumin fractional synthesis rates were not different between the NEAA and CIT groups. Splanchnic extraction of dietary amino acid tended to decrease (p = 0.09) in the CIT group (45.2%) compared with the NEAA group (60.3%). Total differences in AA and NEAA area under the curves between fed-state and postabsorptive-state were significantly higher in the CIT than in the NEAA group. There were no significant differences for body mass index, fat mass (FM), lean mass (LM) or ASMM in the whole population except for a tendential decrease in FM for the citrulline group (p = 0.089). Compared with Day 1, lean mass and ASMM significantly increased (respectively p = 0.016 and p = 0.018) at Day 20 in CIT-treated women (mean respective increase of 1.7 kg and 1.1 kg), and fat mass significantly decreased (p = 0.001) at Day 20 in CIT-group women (mean decrease of 1.3 kg). CONCLUSIONS Our results demonstrate that CIT supplementation has no effect on whole-body protein synthesis or liver protein synthesis in malnourished older subjects. However, CIT supplementation was associated with a higher systemic AA availability. In the subgroup of women, CIT supplementation increased LM and ASMM, and decreased FM.
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Tailoring Assessments and Prescription in Cardiac Rehabilitation for Older Adults: The Relevance of Geriatric Domains.
Fiatarone Singh, MA
Clinics in geriatric medicine. 2019;(4):423-443
Abstract
Older adults have distinctive health challenges that are relevant to the prevention and treatment of cardiovascular diseases and are potentially modifiable by cardiac rehabilitation. Cardiac rehabilitation in older adults provides opportunity to assess sarcopenia, obesity, osteoporosis, frailty, falls risk, arthritis, cognition, special senses, self-efficacy, depression, social support, polypharmacy, and nutritional adequacy. Therefore, broadening standard assessments to include these domains can help detect modifiable vulnerabilities and inform therapeutic priorities.
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Brain volumes and cortical thickness on MRI in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER).
Stephen, R, Liu, Y, Ngandu, T, Antikainen, R, Hulkkonen, J, Koikkalainen, J, Kemppainen, N, Lötjönen, J, Levälahti, E, Parkkola, R, et al
Alzheimer's research & therapy. 2019;(1):53
Abstract
BACKGROUND The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a multicenter randomized controlled trial that reported beneficial effects on cognition for a 2-year multimodal intervention (diet, exercise, cognitive training, vascular risk monitoring) versus control (general health advice). This study reports exploratory analyses of brain MRI measures. METHODS FINGER targeted 1260 older individuals from the general Finnish population. Participants were 60-77 years old, at increased risk for dementia but without dementia/substantial cognitive impairment. Brain MRI scans were available for 132 participants (68 intervention, 64 control) at baseline and 112 participants (59 intervention, 53 control) at 2 years. MRI measures included regional brain volumes, cortical thickness, and white matter lesion (WML) volume. Cognition was assessed at baseline and 1- and 2-year visits using a comprehensive neuropsychological test battery. We investigated the (1) differences between the intervention and control groups in change in MRI outcomes (FreeSurfer 5.3) and (2) post hoc sub-group analyses of intervention effects on cognition in participants with more versus less pronounced structural brain changes at baseline (mixed-effects regression models, Stata 12). RESULTS No significant differences between the intervention and control groups were found on the changes in MRI measures. Beneficial intervention effects on processing speed were more pronounced in individuals with higher baseline cortical thickness in Alzheimer's disease signature areas (composite measure of entorhinal, inferior and middle temporal, and fusiform regions). The randomization group × time × cortical thickness interaction coefficient was 0.198 (p = 0.021). A similar trend was observed for higher hippocampal volume (group × time × hippocampus volume interaction coefficient 0.1149, p = 0.085). CONCLUSIONS The FINGER MRI exploratory sub-study did not show significant differences between the intervention and control groups on changes in regional brain volumes, regional cortical thicknesses, or WML volume after 2 years in at-risk elderly without substantial impairment. The cognitive benefits on processing speed of the FINGER intervention may be more pronounced in individuals with fewer structural brain changes on MRI at baseline. This suggests that preventive strategies may be more effective if started early, before the occurrence of more pronounced structural brain changes. TRIAL REGISTRATION ClinicalTrials.gov, NCT01041989 . Registered January 5, 2010.
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Peri-operative optimisation of elderly and frail patients: a narrative review.
Chan, SP, Ip, KY, Irwin, MG
Anaesthesia. 2019;:80-89
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Abstract
With increasing life expectancy and technological advancement, provision of anaesthesia for elderly patients has become a significant part of the overall case-load. These patients are unique, not only because they are older with more propensity for comorbidity but a decline in physiological reserve and cognitive function invariably accompanies ageing; this can substantially impact peri-operative outcome and quality of recovery. Furthermore, it is not only morbidity and mortality that matters; quality of life is also especially relevant in this vulnerable population. Comprehensive geriatric assessment is a patient-centred and multidisciplinary approach to peri-operative care. The assessment of frailty has a central role in the pre-operative evaluation of the elderly. Other essential domains include optimisation of nutritional status, assessment of baseline cognitive function and proper approach to patient counselling and the decision-making process. Anaesthetists should be proactive in multidisciplinary care to achieve better outcomes; they are integral to the process.