AHRQ seeks information on studies of telemedicine in routine prenatal care

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information on clinical studies that have examined the use of telemedicine for routine prenatal care. The AHRQ's Evidence-based Practice Centers (EPC) Program is currently reviewing the Schedule of Visits and Use of Telemedicine for Routine Antenatal Care. The EPC Program usually conducts manual and electronic database searches of literature, and in this case has decided to supplement its review by requesting information from the public. The EPC Program is seeking to answer key questions about the benefits and risks of different prenatal care schedules, including those which incorporate telemedicine into routine prenatal care. It seeks information from organizations which have completed or ongoing studies in this area. Information is to be submitted by September 23, 2021.

Study of wearable device users finds prolonged COVID symptoms

A study published on July 7, 2021 in JAMA Network Open examined the duration and variation of recovery from acute respiratory illness of participants enrolled in the DETECT (Digital Engagement and Tracking for Early Control and Treatment) study between March 2020 and January 2021. The study found that COVID-19 positive participants took longer to return to baseline for resting heart rate (RHR), sleep and step count, with the greatest effect seen for RHR. All individuals studied reported symptoms of an acute respiratory illness and were tested for COVID-19. Of the 875 participants, 27% tested positive for COVID-19 and 73% tested negative. COVID-19 positive participants did not return to their baseline RHR until an average of 79 days after symptom onset. A small subset of COVID-19 positive individuals (13.7%) did not return to their normal RHR for more than 133 days. Step count and sleep quantity returned to baseline sooner for positive individuals at 32 and 24 days respectively.

FDA publishes new list of clinical outcome assessment tools

The Food and Drug Administration (FDA) has published a new Clinical Outcome Assessment (COA) Compendium, intended to serve as a starting point when considering a COA for use in clinical trials. A COA is an assessment of a clinical outcome that can be made via a report by a clinician, a patient, a non-clinician observer or through a performance-based assessment. The COA Compendium is a communication tool and does not represent FDA guidance.

FDA to issue leapfrog guidance on brain-computer interface devices

The Food and Drug Administration (FDA) will issue a guidance document on May 20, 2021, regarding non-clinical testing and clinical considerations regarding brain-computer interface (BCI) devices. Implanted BCI devices are neuroprostheses that interface with the patient's nervous system to restore lost motor and/or sensory capabilities for patients with paralysis or amputation. The guidance document is a leapfrog guidance, intended to share initial thoughts regarding emerging technologies early in product development, and is nonbinding.


The guidance document describes information that should be included in submission for an investigational device exemption (IDE). Along with detailed technical specifications, the FDA recommends that the applicant submit risk analysis detailing potential hazards of the device from the perspective of the user; description of the software and hardware supporting operation of the device, including information on cybersecurity aspects; and potential use-related hazards that could result from the user interface design.

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AHRQ announces funding opportunity for AI, digital health and clinical decision support

The Agency for Healthcare Research and Quality (AHRQ) announced a funding opportunity for research projects that test digital healthcare interventions aimed at improving quality at the point of care. The digital healthcare solutions tested should use advanced analytics; patient-centered clinician and patient facing digital technologies; or clinical decision-making tools. Applications are due June 16, 2021. For the first two-year phase, the project budget may not exceed $275,000. Projects continued into the second three-year phase may have a total project budget not exceeding $750,000.


For the research area of interest involving advanced analytics, the AHRQ suggested examples such as projects integrating AI during the provision of healthcare services and assessing AI's impact on practice workflow and quality of care, or projects applying machine learning against large health data sets to improve quality at the point of care. Research involving patient-centered digital healthcare technologies could include projects testing innovative technologies that facilitate information sharing between patients and providers, or the use of novel digital solutions for patients with multiple chronic conditions. Examples of projects focused on clinical decision-making support would be projects evaluating a digital point of care solution combining natural language processing with a decision support tool, or projects testing decision-making tools that incorporate the use of patient-generated data and patient-reported outcomes at the point of care.

Stanford research study: Apple Watch useful in assessing frailty in CV patients

A recent Stanford University study compared the effectiveness of the Apple Watch in assessing frailty in cardiovascular patients, in comparison with an in-clinic six-minute walk test (6MWT). The study enrolled 110 patients who were scheduled for vascular or cardiac procedures at a Veterans Administration facility, supplied them with an iPhone and Apple Watch running the VascTrack research application, and followed them for six months. Periodic in-clinic 6MWT results were compared with in-home 6MWT performed using the app, and passive step information collected by the Apple Watch. The tests assessed frailty, defined as walking fewer than 300 meters on an in-clinic 6MWT. The Apple Watch was nearly as effective in assessing frailty via the 6MWT in the home setting as in the clinic setting (83% sensitive and 60% specific in assessing frailty in the home setting, versus 90% sensitive and 85% sensitivity in the clinic setting). Passive data collected at home was nearly as accurate as the 6MWT in-home assessment.

Cleveland Clinic study finds smartphone ECG can be useful for monitoring AF

While availability of direct-to-consumer devices that enable the user to record heart rhythms continues to grow, use of the devices in clinical practice remains low. One reason for limited clinical use is that most devices allow the user to share an electrocardiogram (ECG) recording with their healthcare provider as an email attachment. It is impractical for busy clinicians to incorporate this raw data into normal workflows.

A small Cleveland Clinic study evaluated the use of the Kardia Mobile smartphone monitor coupled with the Kardia Pro (KP) platform for follow-up of patients following successful atrial fibrillation (AF) ablation. The KP platform utilizes artificial intelligence to triage preliminary interpretation of ECG tracings and route suspected abnormal recordings to the electrophysiologist’s in-basket. The study randomized 100 patients who presented three to four months after successful AF ablation into a self-monitoring group using the Kardia Mobile monitor, and a control group following normal standard of care. Healthcare utilization and anxiety were similar for the two groups, but more patients in the control group required additional ECGs or cardiac monitors compared to the self-monitoring group.

The study authors concluded that the KP platform can be effectively incorporated into the care of patients to assist in detection of AF recurrences. They noted:

The synergistic relationship between instantaneous interpretation via the automated algorithm, digital platform, patient, and healthcare provider is key for successful adoption of digital technology into busy clinical practices and will turn the technology into an asset rather than a burden and transform the relationship between the AF patient and the physician into a partnership rather than a unidirectional process.

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