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Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study

ABSTRACT: Introduction This protocol describes an observational study which set out to assess whether frailty and/or multimorbidity correlates with short-term and medium-term outcomes in patients diagnosed with COVID-19 in a European, multicentre setting. Methods and analysis Over a 3-month period we aim to recruit a minimum of 500 patients across 10 hospital sites, collecting baseline data including: patient demographics; presence of comorbidities; relevant blood tests on admission; prescription of ACE inhibitors/angiotensin receptor blockers/non-steroidal anti-inflammatory drugs/immunosuppressants; smoking status; Clinical Frailty Score (CFS); length of hospital stay; mortality and readmission. All patients receiving inpatient hospital care >18 years who receive a diagnosis of COVID-19 are eligible for inclusion. Long-term follow-up at 6 and 12 months is planned. This will assess frailty, quality of life and medical complications. Our primary analysis will be short-term and long-term mortality by CFS, adjusted for age (18–64, 65–80 and >80) and gender. We will carry out a secondary analysis of the primary outcome by including additional clinical mediators which are determined statistically important using a likelihood ratio test. All analyses will be presented as crude and adjusted HR and OR with associated 95% CIs and p values. Ethics and dissemination This study has been registered, reviewed and approved by the following: Health Research Authority (20/HRA1898); Ethics Committee of Hospital Policlinico Modena, Italy (369/2020/OSS/AOUMO); Health and Care Research Permissions Service, Wales; and NHS Research Scotland Permissions Co-ordinating Centre, Scotland. All participating units obtained approval from their local Research and Development department consistent with the guidance from their relevant national organisation. Data will be reported as a whole cohort. This project will be submitted for presentation at a national or international surgical and geriatric conference. Manuscript(s) will be prepared following the close of the project.

SUBMITTER: Price A

PROVIDER: S-EPMC7526029 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:The COVID-19 pandemic has placed unprecedented strain on health-care systems. Frailty is being used in clinical decision making for patients with COVID-19, yet the prevalence and effect of frailty in people with COVID-19 is not known. In the COVID-19 in Older PEople (COPE) study we aimed to establish the prevalence of frailty in patients with COVID-19 who were admitted to hospital and investigate its association with mortality and duration of hospital stay. METHODS:This was an observational cohort study conducted at ten hospitals in the UK and one in Italy. All adults (?18 years) admitted to participating hospitals with COVID-19 were included. Patients with incomplete hospital records were excluded. The study analysed routinely generated hospital data for patients with COVID-19. Frailty was assessed by specialist COVID-19 teams using the clinical frailty scale (CFS) and patients were grouped according to their score (1-2=fit; 3-4=vulnerable, but not frail; 5-6=initial signs of frailty but with some degree of independence; and 7-9=severe or very severe frailty). The primary outcome was in-hospital mortality (time from hospital admission to mortality and day-7 mortality). FINDINGS:Between Feb 27, and April 28, 2020, we enrolled 1564 patients with COVID-19. The median age was 74 years (IQR 61-83); 903 (57·7%) were men and 661 (42·3%) were women; 425 (27·2%) had died at data cutoff (April 28, 2020). 772 (49·4%) were classed as frail (CFS 5-8) and 27 (1·7%) were classed as terminally ill (CFS 9). Compared with CFS 1-2, the adjusted hazard ratios for time from hospital admission to death were 1·55 (95% CI 1·00-2·41) for CFS 3-4, 1·83 (1·15-2·91) for CFS 5-6, and 2·39 (1·50-3·81) for CFS 7-9, and adjusted odds ratios for day-7 mortality were 1·22 (95% CI 0·63-2·38) for CFS 3-4, 1·62 (0·81-3·26) for CFS 5-6, and 3·12 (1·56-6·24) for CFS 7-9. INTERPRETATION:In a large population of patients admitted to hospital with COVID-19, disease outcomes were better predicted by frailty than either age or comorbidity. Our results support the use of CFS to inform decision making about medical care in adult patients admitted to hospital with COVID-19. FUNDING:None.

Project description:BackgroundFrailty is a dynamic condition that is clinically expected to change in older individuals during and around admission to an intermediate care (IC) facility. We aimed to characterize transitions between degrees of frailty before, during, and after admission to IC and assess the impact of these transitions on health outcomes.MethodsMulticentre observational prospective study in IC facilities in Catalonia (North-east Spain). The analysis included all individuals aged ≥ 75 years (or younger with chronic complex or advanced diseases) admitted to an IC facility. The primary outcome was frailty, measured by the Frail-VIG index and categorized into four degrees: no frailty, and mild, moderate, and advanced frailty. The Frail-VIG index was measured at baseline (i.e., 30 days before IC admission) (Frail-VIG0), on IC admission (Frail-VIG1), at discharge (Frail-VIG2), and 30 days post-discharge (Frail-VIG3).ResultsThe study included 483 patients with a mean (SD) age of 81.3 (10.2) years. At the time of admission, 27 (5.6%) had no frailty, and 116 (24%), 161 (33.3%), and 179 (37.1%) mild, moderate, and severe frailty, respectively. Most frailty transitions occurred within the 30 days following admission to IC, particularly among patients with moderate frailty on admission. Most patients maintained their frailty status after discharge. Overall, 135 (28%) patients died during IC stay. Frailty, measured either at baseline or admission, was significantly associated with mortality, although it showed a stronger contribution when measured on admission (HR 1.16; 95%CI 1.10-1.22; p < 0.001) compared to baseline (HR 1.10; 1.05-1.15; p < 0.001). When including frailty measurements at the two time points (i.e., baseline and IC admission) in a multivariate model, frailty measured on IC admission but not at baseline significantly contributed to explaining mortality during IC stay.ConclusionsFrailty status varied before and during admission to IC. Of the serial frailty measures we collected, frailty on IC admission was the strongest predictor of mortality. Results from this observational study suggest that routine frailty measurement on IC admission could aid clinical management decisions.

Project description:ObjectivesTo assess the degree of frailty in older people with different advanced diseases and its relationship with end-of-life illness trajectories and survival.MethodsProspective, observational study, including all patients admitted to the Acute Geriatric Unit of the University Hospital of Vic (Spain) during 12 consecutive months (2014-2015), followed for up to 2 years. Participants were identified as end-of-life people (EOLp) using the NECPAL (NECesidades PALiativas, palliative care needs) tool and were classified according to their dominant illness trajectory. The Frail-VIG index (Valoración Integral Geriátrica, Comprehensive Geriatric Assessment) was used to quantify frailty degree, to calculate the relationship between frailty and mortality (Receiver Operating Characteristic (ROC) curves), and to assess the combined effect of frailty degree and illness trajectories on survival (Cox proportional hazards model). Survival curves were plotted using the Kaplan-Meier estimator with participants classified into four groups (ie, no frailty, mild frailty, moderate frailty and advanced frailty) and were compared using the log-rank test.ResultsOf the 590 persons with a mean (SD) age of 86.4 (5.6) years recruited, 260 (44.1%) were identified as EOLp, distributed into cancer (n=31, 11.9%), organ failure (n=79, 30.4%), dementia (n=86, 33.1%) and multimorbidity (n=64, 24.6%) trajectories. All 260 EOLp had some degree of frailty, mostly advanced frailty (n=184, 70.8%), regardless of the illness trajectory, and 220 (84.6%) died within 2 years. The area under the ROC curve (95% CI) after 2 years of follow-up for EOLp was 0.87 (0.84 to 0.92) with different patterns of survival decline in the different end-of-life trajectories (p<0.0001). Cox regression analyses showed that each additional deficit of the Frail-VIG index increased the risk of death by 61.5%, 30.1%, 29.6% and 12.9% in people with dementia, organ failure, multimorbidity and cancer, respectively (p<0.01 for all the coefficients).ConclusionsAll older people towards the end-of-life in this study were frail, mostly with advanced frailty. The degree of frailty is related to survival across the different illness trajectories despite the differing survival patterns among trajectories. Frailty indexes may be useful to assess end-of-life older people, regardless of their trajectory.

Project description:BackgroundPopulations are ageing globally and Low- and Middle-Income Countries (LMICs) are experiencing the fastest rates of demographic change. Few studies have explored the burden of frailty amongst older people in hospital in LMICs, where healthcare services are having to rapidly adapt to align with the needs of older people. This study aimed to measure the prevalence of frailty amongst older people admitted to hospital in Tanzania and to explore their demographic and clinical characteristics.MethodsThis study had a prospective observational design. Over a six-month period, all adults ≥ 60 years old admitted to medical wards in four hospitals in northern Tanzania were invited to participate. They were screened for frailty using the Clinical Frailty Scale (CFS) and the Frailty Phenotype (FP). Demographic and clinical characteristics of interest were recorded in a structured questionnaire. These included the Barthel Index, the Identification of Elderly Africans Instrumental Activities of Daily Living (IADEA-IADL) and Cognitive (IDEA-Cog) screens, the EURO-D depression scale and Confusion Assessment Method.Results540 adults aged ≥ 60 were admitted, and 308 completed assessment. Frailty was present in 66.6% using the CFS and participants with frailty were significantly older, with lower levels of education and literacy, greater disability, greater comorbidity, poorer cognition and higher levels of delirium. Using the FP, 57.0% of participants were classed as frail though a majority of participants (n = 159, 51.6%) could not be classified due to a high proportion of missing data.ConclusionsThis study indicates that the prevalence of frailty on medical wards in northern Tanzania is high according to the CFS. However, the challenges in operationalising the FP in this setting highlight the need for future work to adapt frailty screening tools for an African context. Future investigations should also seek to correlate frailty status with long-term clinical outcomes after admission in this setting.

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Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study

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