International Changes in COVID-19 Clinical Trajectories Across 315 Hospitals and 6 Countries: Retrospective Cohort Study.

BACKGROUND: Many countries have experienced 2 predominant waves of COVID-19-related hospitalizations. Comparing the clinical trajectories of patients hospitalized in separate waves of the pandemic enables further understanding of the evolving epidemiology, pathophysiology, and health care dynamics of the COVID-19 pandemic. OBJECTIVE: In this retrospective cohort study, we analyzed electronic health record (EHR) data from patients with SARS-CoV-2 infections hospitalized in participating health care systems representing 315 hospitals across 6 countries. We compared hospitalization rates, severe COVID-19 risk, and mean laboratory values between patients hospitalized during the first and second waves of the pandemic. METHODS: Using a federated approach, each participating health care system extracted patient-level clinical data on their first and second wave cohorts and submitted aggregated data to the central site. Data quality control steps were adopted at the central site to correct for implausible values and harmonize units. Statistical analyses were performed by computing individual health care system effect sizes and synthesizing these using random effect meta-analyses to account for heterogeneity. We focused the laboratory analysis on C-reactive protein (CRP), ferritin, fibrinogen, procalcitonin, D-dimer, and creatinine based on their reported associations with severe COVID-19. RESULTS: Data were available for 79,613 patients, of which 32,467 were hospitalized in the first wave and 47,146 in the second wave. The prevalence of male patients and patients aged 50 to 69 years decreased significantly between the first and second waves. Patients hospitalized in the second wave had a 9.9% reduction in the risk of severe COVID-19 compared to patients hospitalized in the first wave (95% CI 8.5%-11.3%). Demographic subgroup analyses indicated that patients aged 26 to 49 years and 50 to 69 years; male and female patients; and black patients had significantly lower risk for severe disease in the second wave than in the first wave. At admission, the mean values of CRP were significantly lower in the second wave than in the first wave. On the seventh hospital day, the mean values of CRP, ferritin, fibrinogen, and procalcitonin were significantly lower in the second wave than in the first wave. In general, countries exhibited variable changes in laboratory testing rates from the first to the second wave. At admission, there was a significantly higher testing rate for D-dimer in France, Germany, and Spain. CONCLUSIONS: Patients hospitalized in the second wave were at significantly lower risk for severe COVID-19. This corresponded to mean laboratory values in the second wave that were more likely to be in typical physiological ranges on the seventh hospital day compared to the first wave. Our federated approach demonstrated the feasibility and power of harmonizing heterogeneous EHR data from multiple international health care systems to rapidly conduct large-scale studies to characterize how COVID-19 clinical trajectories evolve.

Authorship Correction: International Changes in COVID-19 Clinical Trajectories Across 315 Hospitals and 6 Countries: Retrospective Cohort Study.

[This corrects the article DOI: 10.2196/31400.].

Blueprint for harmonising unstandardised disease registries to allow federated data analysis: prepare for the future.

Real-world evidence from multinational disease registries is becoming increasingly important not only for confirming the results of randomised controlled trials, but also for identifying phenotypes, monitoring disease progression, predicting response to new drugs and early detection of rare side-effects. With new open-access technologies, it has become feasible to harmonise patient data from different disease registries and use it for data analysis without compromising privacy rules. Here, we provide a blueprint for how a clinical research collaboration can successfully use real-world data from existing disease registries to perform federated analyses. We describe how the European severe asthma clinical research collaboration SHARP (Severe Heterogeneous Asthma Research collaboration, Patient-centred) fulfilled the harmonisation process from nonstandardised clinical registry data to the Observational Medical Outcomes Partnership Common Data Model and built a strong network of collaborators from multiple disciplines and countries. The blueprint covers organisational, financial, conceptual, technical, analytical and research aspects, and discusses both the challenges and the lessons learned. All in all, setting up a federated data network is a complex process that requires thorough preparation, but above all, it is a worthwhile investment for all clinical research collaborations, especially in view of the emerging applications of artificial intelligence and federated learning.

Bringing spatiotemporal gait analysis into clinical practice: Instrument validation and pilot study of a commercial sensorized carpet.

BACKGROUND AND OBJECTIVE: We illustrate a low-cost platform easing the estimation of spatio-temporal parameters (GA-STP) ready for large-scale deployment in fall prevention. METHODS: We used a commercial sensorized carpet with a limited cost and a very coarse resolution. An instrument validation test was accomplished: the Wilcoxon test for paired samples and the correlation test with Spearman method were used to compare the values computed by the platform with reference ones. Hierarchical clustering using Ward's method and ROC curves have been used to assess the performance in a pilot study enrolling patients. RESULTS: Validation shows no significant difference between computed and reference values of gait speed (ρ-value:0.99; p-value:2.2E-16), step number (ρ-value:0.91; p-value:5.8E-16) and stride-length (ρ-value:0.92; p-value:7.5E-9). The clinical pilot study confirms that the platform may also be used to track the improvements occurring during a rehabilitation program. CONCLUSIONS: We believe that the use of a commercial carpet makes the solution proposed ready to be deployed on a large scale for effectively bringing GA into the clinical practice.

HomeCoRe: Bringing Cognitive Rehabilitation at Home.

CoRe is a system for cognitive rehabilitation that has been successfully used for several years in hospital settings. Leveraging on the positive survey results from the potential final users (patients and their home caregivers), we developed HomeCoRe. This new version of the system will allow discharged patients to continue the rehabilitation treatment at home.

A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease.

BACKGROUND: There is no successful pharmacological treatment for cognitive impairment in Parkinson's Disease, therefore treatments capable of slowing down the progression of cognitive dysfunction are needed. OBJECTIVE: To evaluate the effectiveness of a cognitive training, supported by the CoRe computerized tool, in patients with Parkinson's Disease Mild Cognitive Impairment. METHODS: This is a prospective, open-unblinded, randomized, controlled study. After baseline cognitive assessment (T0), enrolled patients were randomized to receive motor rehabilitation plus cognitive intervention (G1) or motor rehabilitation only (G2). Follow-up assessments were scheduled 4 weeks (T1) and 6 months after (T2). Global cognitive functioning scores (MOCA and MMSE) were considered as primary outcome. Outcome measures at T0, T1 and T2 were compared within- and between-groups. A percentage change score between T0 and next assessments was calculated to identify patients who improved, remain stable or worsened. RESULTS: Differently from G2, G1 showed a medium/large effect size improvement in primary (MoCA) and secondary outcome, both between T0 and T1 and T0 and T2. Moreover, within G1, most patients improved their cognitive state compared to the baseline. CONCLUSIONS: Patients trained with CoRe showed a better evolution of cognitive decline, while untreated patients tended to get worse over time.

Evaluation of an ontology-based system for computerized cognitive rehabilitation.

OBJECTIVES: This paper describes the results of a randomized clinical trial about the effectiveness of a computerized rehabilitation treatment on a sample of 31 patients affected by Parkinson disease. METHODS: Computerized exercises were administered by the therapists to the intervention group (n = 17) through the CoRe tool, which automatically generates a big variety of exercises leveraging on a stimuli set (words, sounds and images) organized into a dedicated ontology. A battery of standard neuropsychological tests was performed for patients' assessment at baseline, after the treatment (that lasted 1 month), and after 6 months from the treatment stop. The control group underwent a sham intervention. RESULTS: Results show a statistically significant clinical benefit from computerized rehabilitation with respect to sham treatment. For the intervention group, response time and response accuracy were integrated into a weighted score that accounts also for the specific cognitive burden of each exercise. Differently from the control group, the majority of patients in the intervention group showed an improvement in that score, more marked in the first week of treatment, and which lasts for the entire treatment period, which could account both for a quick learning effect and for an improvement of cognitive conditions. Good usability of CoRe, already observed in previous studies, was confirmed by the present trial, where the percentage of protocol completion in the intervention group is very high (all but one patient are above 90%). CONCLUSIONS: The CoRe system showed to be effective to improve some cognitive abilities in patients with Parkinson disease. However, after the end of the training, the benefit is hardly maintained over time. These findings support the implementation of CoRe in the clinical routine and the continuation of the treatment after discharge through the use of a homecare version of the system.

Computerized Cognitive Rehabilitation: Comparing Different Human-Computer Interactions.

In this work we describe an experiment involving aphasic patients, where the same speech rehabilitation exercise was administered in three different modalities, two of which are computer-based. In particular, one modality exploits the "Makey Makey", an electronic board which allows interacting with the computer using physical objects.

Computer-based cognitive rehabilitation: the CoRe system.

PURPOSE: This work aims at providing a tool for supporting cognitive rehabilitation. This is a wide field, that includes a variety of diseases and related clinical pictures; for this reason the need arises to have a tool available that overcomes the difficulties entailed by what currently is the most common approach, that is, the so-called pen and paper rehabilitation. METHODS: We first organized a big number of stimuli in an ontology that represents concepts, attributes and a set of relationships among concepts. Stimuli may be words, sounds, 2D and 3D images. Then, we developed an engine that automatically generates exercises by exploiting that ontology. The design of exercises has been carried on in synergy with neuropsychologists and speech therapists. Solutions have been devised aimed at personalizing the exercises according to both patients' preferences and performance. RESULTS: Exercises addressed to rehabilitation of executive functions and aphasia-related diseases have been implemented. The system has been tested on both healthy volunteers (n = 38) and patients (n = 9), obtaining a favourable rating and suggestions for improvements. CONCLUSIONS: We created a tool able to automate the execution of cognitive rehabilitation tasks. We hope the variety and personalization of exercises will allow to increase compliance, particularly from elderly people, usually neither familiar with technology nor particularly willing to rely on it. The next step involves the creation of a telerehabilitation tool, to allow therapy sessions to be undergone from home, thus guaranteeing continuity of care and advantages in terms of time and costs for the patients and the National Healthcare System (NHS). Implications for rehabilitation Cognitive impairments can greatly impact an individual's existence, appreciably reducing his abilities and autonomy, as well as sensibly lowering his quality of life. Cognitive rehabilitation can be used to restore lost brain function or slow down degenerative diseases. Computerization of rehabilitation entails many advantages, but patients - especially elderly people - might be less prone to the use of technology and consequently reluctant towards this innovative therapeutic approach. Our software system, CoRe, supports a therapist during the administration of rehabilitation sessions: exercises can be generated dynamically, thus reducing repetitivity, and patients' performance trends automatically analysed to facilitate the assessment of their progress. Tests performed on both healthy subjects and patients provided useful information that allowed us to define an implementation strategy able to reduce patients' resistance to computerized rehabilitation as much as possible.

A collaborative environment for shared classification of neuroimages: The experience of the Colibri project.

The Colibri project is introduced, whose aim is setting up a shared database of Magnetic Resonance images concerning pediatric patients affected by neurological rare disorders. The project involves 19 Italian centers of excellence in pediatric neuro-radiology and is supported by the nationwide coordinating center for the Information and Communication Technology research infrastructure. After the first year devoted to the design and the implementation, in November 2014 the system finally went into service at the centers involved in the project. This paper illustrates the initial assessment of the user perception and provides some preliminary statistics about its use.