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Introduction: Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer's disease, and what gaps remain. Methods: Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse–Alzheimer's Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach. Results: Four main themes emerged after analysis: data management, participant's wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites. Discussion: The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study. [ABSTRACT FROM AUTHOR]

Background: Stroke survivors are at an increased risk of developing post-stroke cognitive impairment and post-stroke dementia; those at risk could be identified by brain imaging routinely performed at stroke onset. Aim: This systematic review aimed to identify features which are associated with post-stroke cognitive impairment (including dementia) on magnetic resonance imaging (MRI) performed at stroke diagnosis. Summary of review: We searched the literature from inception to January 2022 and identified 10,284 records. We included studies that performed MRI at the time of stroke (0–30 days after a stroke) and assessed cognitive outcome at least 3 months after stroke. We synthesized findings from 26 papers, comprising 27 stroke-populations (N = 13,114, average age range = 40–80 years, 19–62% female). When data were available, we pooled unadjusted (ORu) and adjusted (ORa) odds ratios. We found associations between cognitive outcomes and presence of cerebral atrophy (three studies, N = 453, ORu = 2.48, 95% CI = 1.15–4.62), presence of microbleeds (two studies, N = 9151, ORa = 1.36, 95% CI = 1.08–1.70), and increasing severity of white matter hyperintensities (three studies, N = 704, ORa = 1.26, 95% CI = 1.06–1.49). Increasing cerebral small vessel disease score was associated with cognitive outcome following unadjusted analysis only (two studies, N = 499, ORu = 1.34, 95%CI = 1.12–1.61; three studies, N = 950, ORa = 1.23, 95% CI = 0.96–1.57). Associations remained after controlling for pre-stroke cognitive impairment. We did not find associations between other stroke features and cognitive outcome, or there were insufficient data. Conclusion: Acute stroke MRI features may enable healthcare professionals to identify patients at risk of post-stroke cognitive problems. However, there is still substantial uncertainty about the prognostic utility of acute MRI for this. [ABSTRACT FROM AUTHOR]

Introduction: Frailty, a measure of biological aging, has been linked to worse COVID-19 outcomes. However, as the mortality differs across the COVID-19 waves, it is less clear whether a medical record-based electronic frailty index (eFI) that we have previously developed for older adults could be used for risk stratification in hospitalized COVID-19 patients. Objectives: The aim of the study was to examine the association of frailty with mortality, readmission, and length of stay in older COVID-19 patients and to compare the predictive accuracy of the eFI to other frailty and comorbidity measures. Methods: This was a retrospective cohort study using electronic health records (EHRs) from nine geriatric clinics in Stockholm, Sweden, comprising 3,980 COVID-19 patients (mean age 81.6 years) admitted between March 2020 and March 2022. Frailty was assessed using a 48-item eFI developed for Swedish geriatric patients, the Clinical Frailty Scale, and the Hospital Frailty Risk Score. Comorbidity was measured using the Charlson Comorbidity Index. We analyzed in-hospital mortality and 30-day readmission using logistic regression, 30-day and 6-month mortality using Cox regression, and the length of stay using linear regression. Predictive accuracy of the logistic regression and Cox models was evaluated by area under the receiver operating characteristic curve (AUC) and Harrell's C-statistic, respectively. Results: Across the study period, the in-hospital mortality rate decreased from 13.9% in the first wave to 3.6% in the latest (Omicron) wave. Controlling for age and sex, a 10% increment in the eFI was significantly associated with higher risks of in-hospital mortality (odds ratio = 2.95; 95% confidence interval = 2.42–3.62), 30-day mortality (hazard ratio [HR] = 2.39; 2.08–2.74), 6-month mortality (HR = 2.29; 2.04–2.56), and a longer length of stay (β-coefficient = 2.00; 1.65–2.34) but not with 30-day readmission. The association between the eFI and in-hospital mortality remained robust across the waves, even after the vaccination rollout. Among all measures, the eFI had the best discrimination for in-hospital (AUC = 0.780), 30-day (Harrell's C = 0.733), and 6-month mortality (Harrell's C = 0.719). Conclusion: An eFI based on routinely collected EHRs can be applied in identifying high-risk older COVID-19 patients during the continuing pandemic. [ABSTRACT FROM AUTHOR]

Background: Frail older adults experience higher rates of adverse health outcomes. Therefore, assessing pre-hospital frailty early in the course of care is essential to identify the most vulnerable patients and determine their risk of deterioration. The Clinical Frailty Scale (CFS) is a frailty assessment tool that evaluates pre-hospital mobility, energy, physical activity, and function to generate a score that ranges from very fit to terminally ill. Purpose: To synthesize the evidence of the association between the CFS degree and all-cause mortality, all-cause readmission, length of hospital stay, adverse discharge destination, and functional decline in patients > 65 years in acute clinical settings. Design: Systematic review with narrative synthesis. Methods: Electronic databases (PubMed, EMBASE, CINAHL, Scopus) were searched for prospective or retrospective studies reporting a relationship between pre-hospital frailty according to the CFS and the outcomes of interest from database inception to April 2020. Results: Our search yielded 756 articles, of which 29 studies were included in this review (15 were at moderate risk and 14 at low risk of bias). The included studies represented 26 cohorts from 25 countries (N = 44166) published between 2011 and 2020. All included studies showed that pre-hospital frailty according to the CFS is an independent predictor of all adverse health outcomes included in the review. Conclusion: A primary purpose of the CFS is to grade clinically increased risk (i.e. risk stratification). Our results report the accumulated knowledge on the risk-predictive performance of the CFS and highlight the importance of routinely including frailty assessments, such as the CFS, to estimate biological age, improve risk assessments, and assist clinical decision-making in older adults in acute care. Further research into the potential of the CFS and whether implementing the CFS in routine practice will improve care and patients' quality of life is warranted. [ABSTRACT FROM AUTHOR]