MEDBIZ Big Data Platform Based on Enterprise Support for Digital Healthcare Service using Internet of Medical Things (Preprint)

2021 ◽  
Author(s):  
Hee Young LEE ◽  
Kang Hyun LEE ◽  
Kyu Hee LEE ◽  
Urtnasan Erdenbayar ◽  
Sangwon HWANG ◽  
...  
Keyword(s):  
Big Data ◽  
Real World ◽  
Digital Health ◽  
Healthcare Services ◽  
Mobile App ◽  
Chronic Obstructive ◽  
Real World Data ◽  
Data Platform ◽  
Internet Of Medical Things ◽  
Digital Healthcare

UNSTRUCTURED The aim of this study is to introduce the implemented big data platform (MEDBIZ) based on the internet of medical things (IoMT) supporting digital healthcare services and to discuss about application cases of this platform. Implemented MEDBIZ platform based on the IoMT devices and big data to provide digital healthcare services to the enterprise and users. The big data platform is consisting of four main components: IoMT, Core, Analytics, and Services. IoMT component is used for lifelog data acquisition and collection from the IoMT devices. The core components are composed of the main functional operations including the metadata, resource brokers and computing elements, virtual file system, security, and system logs. Analytics component is covered data analyzing frameworks such as Hadoop, Spark, R, and TensorFlow. Finally, the service component can support the web-based or mobile app-based digital healthcare services through the Open API to the end-users. As a result, an implemented big data platform can provide various digital healthcare services using various IoMT devices. Among them, we are focusing on detailed empirical studies about chronic obstructive pulmonary disease (COPD), metabolic syndrome, vital sign, arrhythmia, and diabetes monitoring services. We demonstrated the implemented MEDBIZ platform based on IoMT supporting digital healthcare services by acquiring real-world data for getting the real-world evidence. And then through this platform, we are developing Software as a Medical Device (SaMD), digital therapeutics, and digital healthcare services, and contributing to the development of the digital health ecosystem.

scholarly journals Real-world longitudinal data collected from the SleepHealth mobile app study

2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Sean Deering ◽  
Abhishek Pratap ◽  
Christine Suver ◽  
A. Joseph Borelli ◽  
Adam Amdur ◽  
...  
Keyword(s):  
Real World ◽  
Large Scale ◽  
Digital Health ◽  
The United States ◽  
Mobile App ◽  
Environmental Data ◽  
Sleep Habits ◽  
Real World Data ◽  
Disease Manifestation ◽  
Novel Approach

AbstractConducting biomedical research using smartphones is a novel approach to studying health and disease that is only beginning to be meaningfully explored. Gathering large-scale, real-world data to track disease manifestation and long-term trajectory in this manner is quite practical and largely untapped. Researchers can assess large study cohorts using surveys and sensor-based activities that can be interspersed with participants’ daily routines. In addition, this approach offers a medium for researchers to collect contextual and environmental data via device-based sensors, data aggregator frameworks, and connected wearable devices. The main aim of the SleepHealth Mobile App Study (SHMAS) was to gain a better understanding of the relationship between sleep habits and daytime functioning utilizing a novel digital health approach. Secondary goals included assessing the feasibility of a fully-remote approach to obtaining clinical characteristics of participants, evaluating data validity, and examining user retention patterns and data-sharing preferences. Here, we provide a description of data collected from 7,250 participants living in the United States who chose to share their data broadly with the study team and qualified researchers worldwide.

scholarly journals Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?

2021 ◽  
pp. 026988112110085
Author(s):  
Robin L Carhart-Harris ◽  
Anne C Wagner ◽  
Manish Agrawal ◽  
Hannes Kettner ◽  
Jerold F Rosenbaum ◽  
...  
Keyword(s):  
Real World ◽  
Best Practice ◽  
Digital Health ◽  
Real World Data ◽  
Treatment Protocols ◽  
World Data ◽  
Cost Efficient ◽  
Personalised Treatment ◽  
New Research ◽  
Confirmatory Trials

Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.

scholarly journals Health and functional status of tiotropium/olodaterol-treated patients with COPD: results from the AERIAL® non-interventional study

2021 ◽  
pp. 00004-2021
Author(s):  
Adrian Gillissen ◽  
Andrea Marseille ◽  
Dirk Skowasch ◽  
John Ritz ◽  
Muriel Mattiucci-Guehlke ◽  
...  
Keyword(s):  
Functional Status ◽  
Primary Endpoint ◽  
Real World ◽  
Chronic Obstructive ◽  
Global Evaluation ◽  
Interventional Study ◽  
Real World Data ◽  
Obstructive Pulmonary Disease ◽  
Continue Treatment ◽  
Reduced Physical Activity

Patients with chronic obstructive pulmonary disease (COPD) often have reduced physical activity, which can impair health status. Real-world data can provide valuable information on the health and functional status of patients with COPD treated with tiotropium/olodaterol.AERIAL® (NCT03165045) was a German, non-interventional study of patients with COPD receiving treatment with tiotropium/olodaterol under real-world conditions for approximately 6 weeks. The primary endpoint was the proportion of patients achieving a decrease of ≥0.4 points in Clinical COPD Questionnaire (CCQ) score. The CCQ-4 subdomain was used to assess functional status, and the Physician's Global Evaluation (PGE) scale to assess the patients’ general condition. Safety was also assessed, as well as patient satisfaction and willingness to continue treatment.Of 1351 screened patients, 1322 were treated and 1140 comprised the full analysis set. The primary endpoint was met: 66.3% of patients achieved a ≥0.4-point decrease in overall CCQ score (mean decrease±standard deviation [sd] 0.78±0.95). Mean decrease ±sd in CCQ symptoms and functional state subdomains were 0.84±1.06 and 0.75±1.05 points, respectively. PGE scores improved. One fatality (not treatment-related) and 23 drug-related adverse events were recorded, most commonly nausea and vertigo. Over 85% of patients were satisfied/very satisfied with tiotropium/olodaterol overall and with the Respimat device, both in terms of inhalation and handling. Most patients (95.2%) expressed willingness to continue treatment.Patients with COPD treated with tiotropium/olodaterol via Respimat in routine clinical practice had clinically relevant improvements in health and functional status compared with baseline.

scholarly journals Heart Snapshot: a broadly validated smartphone measure of VO2max for collection of real world data

2020 ◽  
Author(s):  
Dan E. Webster ◽  
Meghasyam Tummalacherla ◽  
Michael Higgins ◽  
David Wing ◽  
Euan Ashley ◽  
...  
Keyword(s):  
Real World ◽  
Gold Standard ◽  
Large Scale ◽  
Digital Health ◽  
Clinical Care ◽  
Skin Pigmentation ◽  
Epidemiologic Studies ◽  
Step Test ◽  
Real World Data ◽  
Laboratory Equipment

AbstractExpanding access to precision medicine will increasingly require that patient biometrics can be measured in remote care settings. VO2max, the maximum volume of oxygen usable during intense exercise, is one of the most predictive biometric risk factors for cardiovascular disease, frailty, and overall mortality.1,2 However, VO2max measurements are rarely performed in clinical care or large-scale epidemiologic studies due to the high cost, participant burden, and need for specialized laboratory equipment and staff.3,4 To overcome these barriers, we developed two smartphone sensor-based protocols for estimating VO2max: a generalization of a 12-minute run test (12-MRT) and a submaximal 3-minute step test (3-MST). In laboratory settings, Lins concordance for these two tests relative to gold standard VO2max testing was pc=0.66 for 12-MRT and pc=0.61 for 3-MST. Relative to “silver standards”5 (Cooper/Tecumseh protocols), concordance was pc=0.96 and pc=0.94, respectively. However, in remote settings, 12-MRT was significantly less concordant with gold standard (pc=0.25) compared to 3-MST (pc=0.61), though both had high test-retest reliability (ICC=0.88 and 0.86, respectively). These results demonstrate the importance of real-world evidence for validation of digital health measurements. In order to validate 3-MST in a broadly representative population in accordance with the All of Us Research Program6 for which this measurement was developed, the camera-based heart rate measurement was investigated for potential bias. No systematic measurement error was observed that corresponded to skin pigmentation level, operating system, or cost of the phone used. The smartphone-based 3-MST protocol, here termed Heart Snapshot, maintained fidelity across demographic variation in age and sex, across diverse skin pigmentation, and between iOS and Android implementations of various smartphone models. The source code for these smartphone measurements, along with the data used to validate them,6 are openly available to the research community.

scholarly journals Real world evidence in cardiovascular medicine: ensuring data validity in electronic health record-based studies

2019 ◽  
Vol 26 (11) ◽  
pp. 1189-1194 ◽  
Author(s):  
Tina Hernandez-Boussard ◽  
Keri L Monda ◽  
Blai Coll Crespo ◽  
Dan Riskin
Keyword(s):  
Real World ◽  
Digital Health ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Cardiovascular Medicine ◽  
Real World Data ◽  
Chi Square ◽  
Regulatory Decision ◽  
Real World Evidence ◽  
Electronic Health

Abstract Objective With growing availability of digital health data and technology, health-related studies are increasingly augmented or implemented using real world data (RWD). Recent federal initiatives promote the use of RWD to make clinical assertions that influence regulatory decision-making. Our objective was to determine whether traditional real world evidence (RWE) techniques in cardiovascular medicine achieve accuracy sufficient for credible clinical assertions, also known as “regulatory-grade” RWE. Design Retrospective observational study using electronic health records (EHR), 2010–2016. Methods A predefined set of clinical concepts was extracted from EHR structured (EHR-S) and unstructured (EHR-U) data using traditional query techniques and artificial intelligence (AI) technologies, respectively. Performance was evaluated against manually annotated cohorts using standard metrics. Accuracy was compared to pre-defined criteria for regulatory-grade. Differences in accuracy were compared using Chi-square test. Results The dataset included 10 840 clinical notes. Individual concept occurrence ranged from 194 for coronary artery bypass graft to 4502 for diabetes mellitus. In EHR-S, average recall and precision were 51.7% and 98.3%, respectively and 95.5% and 95.3% in EHR-U, respectively. For each clinical concept, EHR-S accuracy was below regulatory-grade, while EHR-U met or exceeded criteria, with the exception of medications. Conclusions Identifying an appropriate RWE approach is dependent on cohorts studied and accuracy required. In this study, recall varied greatly between EHR-S and EHR-U. Overall, EHR-S did not meet regulatory grade criteria, while EHR-U did. These results suggest that recall should be routinely measured in EHR-based studes intended for regulatory use. Furthermore, advanced data and technologies may be required to achieve regulatory grade results.

THE ROLE OF BIG DATA AND REAL WORLD DATA

The Breast ◽  
2019 ◽  
Vol 48 ◽  
pp. S22
Author(s):  
George W. Sledge
Keyword(s):  
Big Data ◽  
Real World ◽  
Real World Data ◽  
World Data

Pharmacological Management of Chronic Obstructive Lung Disease (COPD). Evidence from a Real-World Perspective - Part 2

2019 ◽  
Vol 26 (10) ◽  
pp. 1734-1745 ◽  
Author(s):  
Aliaksei Kisialiou ◽  
Giulia Prinzi ◽  
Palma Lamonaca ◽  
Vittorio Cardaci ◽  
Carlo Tomino ◽  
...  
Keyword(s):  
Real World ◽  
Chronic Obstructive Lung Disease ◽  
Chronic Obstructive ◽  
World Population ◽  
Real World Data ◽  
Comprehensive Overview ◽  
Adherence To Guidelines ◽  
Pharmacological Management ◽  
Copd Patients ◽  
Training Research

Background: We report a comprehensive overview of current COPD therapies from a real-world experience. Objective: Critically review the opportunities and the challenges occurring in the real-world treatment of COPD. Methods: This is a review that also report results from COPD patients treated with standardized therapy including pulmonary rehabilitation (Real World Data – RWD). Conclusion: Comprehensive assessment of COPD management requires strategies able to evaluate efficacy and usefulness in a real-world population, that take into account the interaction between experience and academic training, research, adherence to guidelines and judgments in order to plan the appropriate and optimum use of available strategies.

Treatment patterns and characteristics of acute promyelocytic leukemia (APL) patients receiving arsenic trioxide (ATO) therapy in a real-world setting.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18522-e18522
Author(s):  
Boxiong Tang ◽  
Susan Gabriel ◽  
Jifang Zhou ◽  
Ashutosh K. Pathak ◽  
Debra Irwin ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Claims Data ◽  
Treatment Patterns ◽  
Chronic Obstructive ◽  
Administrative Claims ◽  
First Line ◽  
Real World Data ◽  
World Data

e18522 Background: Clinical trials have shown that low-risk APL patients had significantly better outcomes when receiving first-line all-trans retinoic acid (ATRA) + ATO compared with standard ATRA + chemotherapy. Few published studies have used real-world data to describe patients using ATO and their current treatment patterns. This study used United States (US) administrative claims data to describe treatment patterns and characteristics of patients receiving first-line ATO. Methods: This retrospective, observational cohort study used claims data from the MarketScan databases. As there is no ICD-9-CM diagnosis code for APL, ATO treatment was used as a surrogate for the diagnosis of APL since ATO is typically used only in APL patients. Patients were selected if they had ≥1 claims for ATO between January 1, 2000, and June 30, 2015. Date of first use was designated the index date. To identify first-line ATO initiation, patients with ATRA or other APL-indicated chemotherapy claims any time before the index date were excluded. Variable baseline and follow-up periods consisting of ≥3 months of pre-index and ≥30 days of post-index continuous enrollment in medical and pharmacy benefit were used. Results: In total, 331 patients were identified with a subset (n = 265) having ≥2 claims for ATO. The analysis focused on these 265 patients, 54% of whom were male. Mean age was 60.6 years; 45% were covered by Medicare. The most common comorbid conditions measured were diabetes (6%), chronic obstructive pulmonary disease (5%), and congestive heart failure (4%). The most commonly selected APL treatments administered during follow-up were ATRA (17%) and daunorubicin (9%) with the use of idarubicin, cytarabine, and mitoxantrone at less than 3%. Maintenance therapy with methotrexate or 6-mercaptopurine was observed in 7% and 6% of patients, respectively. Conclusions: This is one of the first studies to examine patient characteristics and treatment patterns for first-line ATO using real-world data. Further research is needed to evaluate outcomes for patients receiving ATO as first-line therapy and to re-evaluate treatment guidelines in light of these outcomes.

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