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A study protocol for an observational cohort investigating COGnitive outcomes and WELLness in survivors of critical illness: the COGWELL study.

ABSTRACT: INTRODUCTION:Up to 9 out of 10 intensive care unit (ICU) survivors will suffer some degree of cognitive impairment at hospital discharge and approximately half will have decrements that persist for years. The mechanisms for this newly acquired brain injury are poorly understood. The purpose of this study is to describe the prevalence of sleep abnormalities and their association with cognitive impairment, examine a well-known genetic risk factor for dementia (Apolipoprotein E ?4) that may allow for genetic risk stratification of ICU survivors at greatest risk of cognitive impairment and determine if electroencephalography (EEG) is an independent predictor of long-term cognitive impairment and possibly a candidate intermediate end point for future clinical trials. METHODS AND ANALYSIS:This is a multisite, prospective, observational cohort study. The setting for this trial will be medical and surgical ICUs of five large tertiary care referral centres. The participants will be adult patients admitted to a study ICU and invasively ventilated for ?3 days . Participants will undergo follow-up within 7 days of ICU discharge, 6?months and 1?year. At each time point, patients will have an EEG, blood work (biomarkers; gene studies), sleep study (actigraphy), complete a number of questionnaires as well as undergo neuropsychological testing. The primary outcome of this study will be long-term cognitive function at 12?months follow-up as measured by the Repeatable Battery for the Assessment of Neuropsychological Status and Trails Making Test B. ETHICS AND DISSEMINATION:The study has received the following approvals: University Health Network Research Ethics Committee (13-6425-BE), Sunnybrook Health Centre Research Ethics Committee (365-2013), Mount Sinai Research Ethics Committee (14-0194-E) and St. Michael's Hospital Research Ethics Committee (14-295). Results will be made available to critical care survivors, their caregivers, the funders, the critical care societies and other researchers. TRIAL REGISTRATION NUMBER:NCT02086877; Pre-results.

SUBMITTER: Wilcox ME

PROVIDER: S-EPMC5734403 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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A study protocol for an observational cohort investigating COGnitive outcomes and WELLness in survivors of critical illness: the COGWELL study.

Wilcox M Elizabeth ME Lim Andrew S AS McAndrews Mary P MP Wennberg Richard A RA Pinto Ruxandra L RL Black Sandra E SE Walczak Karolina D KD Friedrich Jan O JO Taglione Michael S MS Rubenfeld Gordon D GD

BMJ open 20170713 7

<h4>Introduction</h4>Up to 9 out of 10 intensive care unit (ICU) survivors will suffer some degree of cognitive impairment at hospital discharge and approximately half will have decrements that persist for years. The mechanisms for this newly acquired brain injury are poorly understood. The purpose of this study is to describe the prevalence of sleep abnormalities and their association with cognitive impairment, examine a well-known genetic risk factor for dementia (Apolipoprotein E ε4) that may ...[more]

PMID: 28710215

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Project description:IntroductionSocial networks play a role in slowing the development of dementia. However, there is a need for further investigation of the effects of improving social networks on health-related quality of life and cognitive performance. Targeted community aged care services are a central strategy for supporting older adults to initiate and maintain their social engagement with other individuals at all stages of later life. This protocol describes a prospective observational cohort study aimed at (1) characterising interpersonal relationships in older adults receiving community care services, (2) assessing the relationship social networks and health-related quality of life and cognition and (3) identifying the association between community care use, social networks and cognition. The findings will contribute to our understanding of how specific social network structures and social support services can maintain cognitive function in community-dwelling older adults.Methods and analysisThis is a prospective, observational cohort study of 201 older Australians residing in the community and receiving care services from one of three aged care organisations. Clients with a history of neurological injury will be excluded. Participants will undergo baseline measures of social networks, health-related quality of life and cognitive function, and a follow-up at 6 months. Service use and sociodemographic variables will also be collected. The primary outcome is cognitive function, and secondary outcomes include social networks and health-related quality of life. Multivariable linear regression will test the hypothesis that increased social networks are associated with an increase in cognitive function.Ethics and disseminationApproval of the study by Macquarie University Research Ethics Committee (reference number 5201831394062) has been obtained. This work will be disseminated by publication of peer-reviewed manuscripts, presentations in abstract form at scientific meetings and results will be made available to home and community-based care older adults and care staff of the involved organisations.Trial registration numberACTRN12618001723279; Pre-results.

Project description:BackgroundLittle is known about risk factors associated with out-of-hospital outcomes in survivors of critical illness. We hypothesized that the presence of nucleated red blood cells in patients who survived critical care would be associated with adverse outcomes following hospital discharge.MethodsWe performed a two-center observational cohort study of patients treated in medical and surgical intensive care units in Boston, Massachusetts. All data were obtained from the Research Patient Data Registry at Partners HealthCare. We studied 2878 patients, age???18 years, who received critical care between 2011 and 2015 and survived hospitalization. The exposure of interest was nucleated red blood cells occurring from 2 days prior to 7 days after critical care initiation. The primary outcome was mortality in the 90 days following hospital discharge. Secondary outcome was unplanned 30-day hospital readmission. Adjusted odds ratios were estimated by multivariable logistic regression models with inclusion of covariate terms thought to plausibly interact with both nucleated red blood cells and outcome. Adjustment included age, race (white versus nonwhite), gender, Deyo-Charlson Index, patient type (medical versus surgical), sepsis and acute organ failure.ResultsIn patients who received critical care and survived hospitalization, the absolute risk of 90-day postdischarge mortality was 5.9%, 11.7%, 15.8% and 21.9% in patients with 0/?l, 1-100/?l, 101-200/?l and more than 200/?l nucleated red blood cells respectively. Nucleated red blood cells were a robust predictor of postdischarge mortality and remained so following multivariable adjustment. The fully adjusted odds of 90-day postdischarge mortality in patients with 1-100/?l, 101-200/?l and more than 200/?l nucleated red blood cells were 1.77 (95% CI, 1.23-2.54), 2.51 (95% CI, 1.36-4.62) and 3.72 (95% CI, 2.16-6.39) respectively, relative to patients without nucleated red blood cells. Further, the presence of nucleated red blood cells is a significant predictor of the odds of unplanned 30-day hospital readmission.ConclusionIn critically ill patients who survive hospitalization, the presence of nucleated red blood cells is a robust predictor of postdischarge mortality and unplanned hospital readmission.

Project description:INTRODUCTION:When adolescents experience complex psychiatric and social problems, numerous healthcare services usually become involved. In these cases, fragmentation of care services is a risk that often results in both ineffective care and in patients disengaging from care services. To address these issues, Youth Flexible Assertive Community Treatment (Youth Flexible ACT) was developed in the Netherlands. This client-centred service delivery model aims to tackle the fragmented care system by providing psychiatric treatment and support in a flexible and integrated manner. While Youth Flexible ACT is gaining in popularity, the effectiveness of the care model remains largely unexamined. METHODS AND ANALYSIS:Here, we present an observational prospective cohort (2017-2021) in which a broad range of treatment outcomes will be monitored. The primary aim of the study is to examine change in treatment outcomes over the course of the Flexible ACT care. The secondary aim is to examine the association between (elements of) Youth Flexible ACT model fidelity and treatment outcomes. An estimated total number of 200 adolescents who receive care from one of the 16 participating Youth Flexible ACT teams will be included in the study. Participants will be asked to complete assessments at four time points in 6-month intervals, resulting in a study duration of 18 months. Latent growth curve analysis will be conducted to examine change in psychosocial functioning over time and its relation to model fidelity. ETHICS AND DISSEMINATION:This study received ethical approval from Trimbos Ethics Committee (201607_75-FACT2). This approval applies for all participating institutions. The results of the study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. Results will be disseminated via peer-reviewed academic journals and presentations at conferences. In addition, results will be made available for participating sites, funders and researchers.

Project description:BackgroundSepsis, trauma, and burn injury acutely depress systolic and diastolic cardiac function; data on long-term cardiac sequelae of pediatric critical illness are sparse. This study evaluated long-term systolic and diastolic function, myocardial fibrosis, and exercise tolerance in survivors of severe pediatric burn injury.MethodsSubjects at least 5 years after severe burn (post-burn:PB) and age-matched healthy controls (HC) underwent echocardiography to quantify systolic function (ejection fraction[EF%]), diastolic function (E/e'), and myocardial fibrosis (calibrated integrated backscatter) of the left ventricle. Exercise tolerance was quantified by oxygen consumption (VO2) and heart rate at rest and peak exercise. Demographic information, clinical data, and biomarker expression were used to predict long-term cardiac dysfunction and fibrosis.FindingsSixty-five subjects (PB:40;HC:25) were evaluated. At study date, PB subjects were 19±5 years, were at 12±4 years postburn, and had burns over 59±19% of total body surface area, sustained at 8±5 years of age. The PB group had lower EF% (PB:52±9%;HC:61±6%; p=0.004), E/e' (PB:9.8±2.9;HC: 5.4±0.9;p<0.0001), VO2peak (PB:37.9±12;HC: 46±8.32 ml/min/kg; p=0.029), and peak heart rate (PB:161±26;HC:182±13bpm;p=0.007). The PB group had moderate (28%) or severe (15%) systolic dysfunction, moderate (50%) or severe diastolic dysfunction (21%), and myocardial fibrosis (18%). Biomarkers and clinical parameters predicted myocardial fibrosis, systolic dysfunction, and diastolic dysfunction.InterpretationSevere pediatric burn injury may have lasting impact on cardiac function into young adulthood and is associated with myocardial fibrosis and reduced exercise tolerance. Given the strong predictive value of systolic and diastolic dysfunction, these patients might be at increased risk for early heart failure, associated morbidity, and mortality.FundingConflicts of Interest and Sources of Funding: The authors do not have any conflicts of interest to declare. This work was supported by NIH (P50 GM060338, R01 GM056687, R01 HD049471, R01 GM112936, R01-GM56687 and T32 GM008256), NIDILRR (H133A120091, 90DP00430100), Shriners Hospitals for Children (84080, 79141, 79135, 71009, 80100, 71008, 87300 and 71000), FAER (MRTG CON14876), and the Department of Defense (W81XWH-14-2-0162 and W81XWH1420162). It was also made possible with the support of UTMB's Institute for Translational Sciences, supported in part by a Clinical and Translational Science Award (UL1TR000071) from the National Center for Advancing Translational Sciences (NIH).

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A study protocol for an observational cohort investigating COGnitive outcomes and WELLness in survivors of critical illness: the COGWELL study.

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A study protocol for an observational cohort investigating COGnitive outcomes and WELLness in survivors of critical illness: the COGWELL study.

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