scholarly journals Developing the accuracy of vital signs measurements by the LifelightTM software application in comparison to standard of care methods: an observational study protocol (Preprint)

2019 ◽  
Author(s):  
Thomas L Jones ◽  
Emily Heiden ◽  
Felicity Mitchell ◽  
Carole Fogg ◽  
Sharon McCready ◽  
...  
Keyword(s):  
Vital Sign ◽  
Large Scale ◽  
Clinical Decision Making ◽  
Digital Health ◽  
Clinical Care ◽  
Population Sample ◽  
Standard Of Care ◽  
Health Technology ◽  
Software Application ◽  
Health And Social Care

BACKGROUND Vital sign measurements are an integral component of clinical care, but current challenges with the accuracy and timeliness of patient observations can impact appropriate clinical decision making. Advanced technologies using techniques such as photoplethysmography have the potential to automate non-contact physiological monitoring and recording, improving the quality and accessibility of this essential clinical information. OBJECTIVE To develop the algorithm used in the LifelightTM software application and improve the accuracy of its estimated heart rate, respiratory rate, oxygen saturation and blood pressure measurements METHODS This preliminary study will compare measurements predicted by the LifelightTM software with standard of care measurements for an estimated population sample of 2000 inpatients, outpatients and healthy people attending a large acute hospital. Both training datasets and validation datasets will be analysed to assess the degree of correspondence between the vital sign measurements predicted by the LifelightTM software and the direct physiological measurements taken using standard of care methods. Sub group analyses will explore how the performance of the algorithm varies with particular patient characteristics, including age, sex, health condition and medication. RESULTS Recruitment of participants to this study began in July 2018 and data collection will continue for a planned study period of 12 months. CONCLUSIONS Digital health technology is a rapidly evolving area for health and social care. Following this initial exploratory study to develop and refine the LifelightTM software application, subsequent work will evaluate its performance across a range of health characteristics and extended validation trials will support its pathway to registration as a medical device. Innovations in health technology such as this may provide valuable opportunities for increasing the efficiency and accessibility of vital sign measurements and improve healthcare services on a large scale across multiple health and care settings. CLINICALTRIAL

scholarly journals Creating boundaries to empower digital health technology

BJPsych Open ◽  
2018 ◽  
Vol 4 (4) ◽  
pp. 235-237 ◽  
Author(s):  
Honor Hsin ◽  
John Torous
Keyword(s):  
Best Practices ◽  
Digital Health ◽  
Clinical Care ◽  
Life Sciences ◽  
Standard Of Care ◽  
Health Technology ◽  
Clinical Diagnostics ◽  
Direct To Consumer ◽  
The Right

SummaryThe potential of digital health tools such as smartphones and sensors to increase access to and enhance delivery of healthcare is well known. However, a lack of regulation and delineation between those technologies seeking to offer direct clinical diagnostics and treatments and those involving clinical care enhancements or direct-to-consumer resources has led to patient and clinician confusion about the appropriate use and role of digital health. Here, we propose that creating boundaries and better defining the scope of digital health technology will advance the field through matching the right use cases with the right tools. We further propose that ethical clinicians, as stewards of standard of care, are well suited to uphold these boundaries and to safeguard best practices in digital health.Declaration of interestH.H. is an employee of Verily Life Sciences and owns equity in this company. The views expressed here are those of the authors and are not official views of Verily Life Sciences.

scholarly journals Realities of conducting digital health research: Challenges to consider

2019 ◽  
Vol 5 ◽  
pp. 205520761986946
Author(s):  
Emily de Redon ◽  
Amanda Centi
Keyword(s):  
Large Scale ◽  
Digital Health ◽  
Clinical Care ◽  
Health Sector ◽  
Healthcare Systems ◽  
Research Challenges ◽  
Technological Advances ◽  
Barriers To Implementation ◽  
Smart Health ◽  
Health Applications

The health sector has been slow to adopt and integrate new technological advances into antiquated workflows and processes. The onset of smart health applications and devices has initiated a push for healthcare systems as well as physicians to incorporate and utilize such technology and the big data it collects. However, without considering the challenges experienced in large-scale trials, physicians and their clinics will run into similar barriers to implementation and uptake. Thoughtful implementation and preparation will make the use of such technological advances possible, palatable and effective in improving clinical care.

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 The Rationale for Potential Pharmacotherapy of COVID-19

2020 ◽  
Vol 13 (5) ◽  
pp. 96 ◽  
Author(s):  
Maha Saber-Ayad ◽  
Mohamed A. Saleh ◽  
Eman Abu-Gharbieh
Keyword(s):  
Clinical Trials ◽  
Health Care Professionals ◽  
Large Scale ◽  
Clinical Care ◽  
Management Strategies ◽  
Standard Of Care ◽  
World Health ◽  
High Morbidity ◽  
Human Coronavirus ◽  
The World

On 11 March 2020, the coronavirus disease (COVID-19) was defined by the World Health Organization as a pandemic. Severe acute respiratory syndrome-2 (SARS-CoV-2) is the newly evolving human coronavirus infection that causes COVID-19, and it first appeared in Wuhan, China in December 2019 and spread rapidly all over the world. COVID-19 is being increasingly investigated through virology, epidemiology, and clinical management strategies. There is currently no established consensus on the standard of care in the pharmacological treatment of COVID-19 patients. However, certain medications suggested for other diseases have been shown to be potentially effective for treating this infection, though there has yet to be clear evidence. Therapies include new agents that are currently tested in several clinical trials, in addition to other medications that have been repurposed as antiviral and immune-modulating therapies. Previous high-morbidity human coronavirus epidemics such as the 2003 SARS-CoV and the 2012 Middle East respiratory syndrome coronavirus (MERS-CoV) prompted the identification of compounds that could theoretically be active against the emerging coronavirus SARS-CoV-2. Moreover, advances in molecular biology techniques and computational analysis have allowed for the better recognition of the virus structure and the quicker screening of chemical libraries to suggest potential therapies. This review aims to summarize rationalized pharmacotherapy considerations in COVID-19 patients in order to serve as a tool for health care professionals at the forefront of clinical care during this pandemic. All the reviewed therapies require either additional drug development or randomized large-scale clinical trials to be justified for clinical use.

A roadmap for remote digital health technology for Motor Neuron Disease (Preprint)

2021 ◽  
Author(s):  
Ruben P.A. van Eijk ◽  
Anita Beelen ◽  
Esther T. Kruitwagen ◽  
Deirdre Murray ◽  
Ratko Radakovic ◽  
...  
Keyword(s):  
Motor Neuron ◽  
Motor Neuron Disease ◽  
Real World ◽  
Clinical Decision Making ◽  
Digital Health ◽  
Health Technology ◽  
Innovative Technology ◽  
Progression Rate ◽  
Healthcare Technology ◽  
Digital Healthcare

UNSTRUCTURED Despite recent and compelling technological advances, the real-world implementation of remote digital health technology in care and monitoring of patients with motor neuron disease (MND) has not yet been realized. Digital health technology may increase the accessibility to and personalization of care, whereas remote biosensors could optimize the collection of vital clinical parameters, irrespective of the patients’ ability to visit the clinic. To facilitate wide-scale adoption of digital healthcare technology, and to align current initiatives, we outline a roadmap that (1) will identify clinically relevant digital parameters, (2) mediate the development of benefit-to-burden criteria for innovative technology and (3) direct the validation, harmonization and adoption of digital healthcare technology in real-world settings. We define two key end-products of the roadmap: (1) a set of reliable digital parameters to capture data, collected under free-living conditions, that reflect patient-centric measures and facilitate clinical decision-making, and (2) an integrated, open-source system that provides personalized feedback to patients, healthcare providers, clinical researchers and caregivers, linked to a flexible and adaptable ICT platform that integrates patient data in real time. Given the ever-changing care needs of patients and the relentless progression rate of MND, the adoption of digital healthcare technology will significantly benefit the delivery of care and accelerate the development of effective treatments.

Digital Connectivity: The Sixth Vital Sign

2021 ◽  
pp. 193229682110152
Author(s):  
David C. Klonoff ◽  
Trisha Shang ◽  
Jennifer Y. Zhang ◽  
Eda Cengiz ◽  
Chhavi Mehta ◽  
...  
Keyword(s):  
Vital Sign ◽  
Pressure Pulse ◽  
Digital Health ◽  
Clinical Care ◽  
Vital Signs ◽  
Personal Data ◽  
Skills Training ◽  
Digital Data ◽  
Digital Monitoring ◽  
Continuous Glucose Monitors

Digital health and telehealth connectivity have become important aspects of clinical care. Connected devices, including continuous glucose monitors and automated insulin delivery systems for diabetes, are being used increasingly to support personalized clinical decisions based on automatically collected data. Furthermore, the development, demand, and coverage for telehealth have all recently expanded, as a result of the COVID-19 pandemic. Medical care, and especially diabetes care, are therefore becoming more digital through the use of both connected digital health devices and telehealth communication. It has therefore become necessary to integrate digital data into the electronic health record and maintain personal data confidentiality, integrity, and availability. Connected digital monitoring combined with telehealth communication is known as virtual health. For this virtual care paradigm to be successful, patients must have proper skills, training, and equipment. We propose that along with the five current vital signs of blood pressure, pulse, respiratory rate, temperature, and pain, at this time, digital connectivity should be considered as the sixth vital sign. In this article, we present a scale to assess digital connectivity.

scholarly journals Clinical Impact of Prospective Whole Genome Sequencing in Sarcoma Patients

Cancers ◽  
2022 ◽  
Vol 14 (2) ◽  
pp. 436
Author(s):  
Luuk J. Schipper ◽  
Kim Monkhorst ◽  
Kris G. Samsom ◽  
Linda J.W. Bosch ◽  
Petur Snaebjornsson ◽  
...  
Keyword(s):  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Large Scale ◽  
Clinical Decision Making ◽  
Therapeutic Potential ◽  
Treatment Plan ◽  
Clinical Care ◽  
Unmet Need ◽  
Whole Genome ◽  
Tertiary Referral Center

With more than 70 different histological sarcoma subtypes, accurate classification can be challenging. Although characteristic genetic events can largely facilitate pathological assessment, large-scale molecular profiling generally is not part of regular diagnostic workflows for sarcoma patients. We hypothesized that whole genome sequencing (WGS) optimizes clinical care of sarcoma patients by detection of diagnostic and actionable genomic characteristics, and of underlying hereditary conditions. WGS of tumor and germline DNA was incorporated in the diagnostic work-up of 83 patients with a (presumed) sarcomas in a tertiary referral center. Clinical follow-up data were collected prospectively to assess impact of WGS on clinical decision making. In 12/83 patients (14%), the genomic profile led to revision of cancer diagnosis, with change of treatment plan in eight. All twelve patients had undergone multiple tissue retrieval procedures and immunohistopathological assessments by regional and expert pathologists prior to WGS analysis. Actionable biomarkers with therapeutic potential were identified for 30/83 patients. Pathogenic germline variants were present in seven patients. In conclusion, unbiased genomic characterization with WGS identifies genomic biomarkers with direct clinical implications for sarcoma patients. Given the diagnostic complexity and high unmet need for new treatment opportunities in sarcoma patients, WGS can be an important extension of the diagnostic arsenal of pathologists.

scholarly journals Clinical Integration of Genome Diagnostics for Congenital Anomalies of the Kidney and Urinary Tract

2020 ◽  
Vol 16 (1) ◽  
pp. 128-137 ◽  
Author(s):  
Rik Westland ◽  
Kirsten Y. Renkema ◽  
Nine V.A.M. Knoers
Keyword(s):  
Urinary Tract ◽  
Congenital Anomalies ◽  
Large Scale ◽  
Clinical Decision Making ◽  
Clinical Medicine ◽  
Clinical Care ◽  
Clinical Decision ◽  
Environment Interaction ◽  
Clinical Integration ◽  
Urinary Tract Malformations

Revolutions in genetics, epigenetics, and bioinformatics are currently changing the outline of diagnostics and clinical medicine. From a nephrologist’s perspective, individuals with congenital anomalies of the kidney and urinary tract (CAKUT) are an important patient category: not only is CAKUT the predominant cause of kidney failure in children and young adults, but the strong phenotypic and genotypic heterogeneity of kidney and urinary tract malformations has hampered standardization of clinical decision making until now. However, patients with CAKUT may benefit from precision medicine, including an integrated diagnostics trajectory, genetic counseling, and personalized management to improve clinical outcomes of developmental kidney and urinary tract defects. In this review, we discuss the present understanding of the molecular etiology of CAKUT and the currently available genome diagnostic modalities in the clinical care of patients with CAKUT. Finally, we discuss how clinical integration of findings from large-scale genetic, epigenetic, and gene-environment interaction studies may improve the prognosis of all individuals with CAKUT.

Whole-genome sequencing to improve sarcoma diagnosis and patient care.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11540-11540
Author(s):  
Luuk J. Schipper ◽  
Kim Monkhorst ◽  
Kris Samsom ◽  
Petur Snaebjornsson ◽  
Hester Van Boven ◽  
...  
Keyword(s):  
Decision Making ◽  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Large Scale ◽  
Clinical Decision Making ◽  
Therapeutic Potential ◽  
Clinical Care ◽  
Unmet Need ◽  
Clinical Decision ◽  
Whole Genome

11540 Background: With more than 70 different histological subtypes, accurate classification sarcomas is challenging. Although pathognomonic genetic events aid accurate classification, large-scale molecular profiling is generally not incorporated in regular diagnostic workflows for sarcoma patients. We hypothesized that whole genome sequencing (WGS) optimizes clinical care of sarcoma patients by detection of pathognomonic and actionable variants, and of underlying hereditary conditions. Methods: WGS of tumor and germline DNA was incorporated in the diagnostic work-up of 83 patients with a (presumed) sarcoma as part of the WIDE (Whole genome sequencing Implementation in standard Diagnostics for Every cancer patient) study in a tertiary referral center. WGS results were reported back to the pathologist and treating clinician. Clinical follow-up data were collected prospectively to assess impact of WGS on clinical decision making. Results: WGS analysis had impact on multiple levels. First, in 14% of cases (12/83 patients), the genomic profile led to a revision of the diagnosis (table). All patients had undergone multiple diagnostic procedures (mean number: 4) and pathologist assessments (mean: 6) before WGS analysis was performed. Secondly, actionable biomarkers with therapeutic potential were detected for 36/83 patients and finally, 8 pathogenic germline variants were present. Taken together, WGS had implications for clinical decision making in 52% of patients with (presumed) sarcomas. Conclusions: WGS is an important extension of the diagnostic arsenal of pathologists and has contributed to change of care in 52% of patients with sarcomas. Given the diagnostic complexity and high unmet need for new treatment opportunities in sarcomas we advocate the use of WGS for sarcoma patients early in the disease course. Clinical trial information: NL68609.031.18. [Table: see text]

1193-P: “TechQuity” in Diabetes: Does Digital Health Technology Improve Equity?

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 1193-P
Author(s):  
KELLY JEAN CRAIG ◽  
KYU B. RHEE
Keyword(s):  
Digital Health ◽  
Health Technology
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