EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration.

The EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist was developed by a multidisciplinary group of content experts convened by the Digital Medicine Society, representing the clinical sciences, data management, technology development, and biostatistics. The aim of EVIDENCE is to promote high quality reporting in studies where the primary objective is an evaluation of a digital measurement product or its constituent parts. Here we use the terms digital measurement product and connected sensor technology interchangeably to refer to tools that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function.

Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health.

Background: With the rise of connected sensor technologies, there are seemingly endless possibilities for new ways to measure health. These technologies offer researchers and clinicians opportunities to go beyond brief snapshots of data captured by traditional in-clinic assessments, to redefine health and disease. Given the myriad opportunities for measurement, how do research or clinical teams know what they be measuring? Patient engagement, early and often, is paramount to thoughtfully selecting what is most important.

An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19.

The novel coronavirus disease 2019 (COVID-19) global pandemic has shifted how many patients receive outpatient care. Telehealth and remote monitoring have become more prevalent, and measurements taken in a patient's home using biometric monitoring technologies (BioMeTs) offer convenient opportunities to collect vital sign data. Healthcare providers may lack prior experience using BioMeTs in remote patient care, and, therefore, may be unfamiliar with the many versions of BioMeTs, novel data collection protocols, and context of the values collected.

Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept.

Erratum: Publisher Correction: Modernizing and designing evaluation frameworks for connected sensor technologies in medicine.

[This corrects the article DOI: 10.1038/s41746-020-0237-3.].

Modernizing and designing evaluation frameworks for connected sensor technologies in medicine.

This manuscript is focused on the use of connected sensor technologies, including wearables and other biosensors, for a wide range of health services, such as collecting digital endpoints in clinical trials and remotely monitoring patients in clinical care. The adoption of these technologies poses five risks that currently exceed our abilities to evaluate and secure these products: (1) validation, (2) security practices, (3) data rights and governance, (4) utility and usability; and (5) economic feasibility. In this manuscript we conduct a landscape analysis of emerging evaluation frameworks developed to better manage these risks, broadly in digital health.

A systematic review of feasibility studies promoting the use of mobile technologies in clinical research.

Mobile technologies, such as smart phone applications, wearables, ingestibles, and implantables, are increasingly used in clinical research to capture study endpoints. On behalf of the Clinical Trials Transformation Initiative, we aimed to conduct a systematic scoping review and compile a database summarizing pilot studies addressing mobile technology sensor performance, algorithm development, software performance, and/or operational feasibility, in order to provide a resource for guiding decisions about which technology is most suitable for a particular trial. Our systematic search identified 275 publications meeting inclusion criteria.

Electronic Cigarette Use Among Counseled Tobacco Users Hospitalized in 2015.

Objectives: Few studies have examined the prevalence of electronic cigarette use among the inpatient population regardless of the patients' cessation goals. The objectives of this study were to examine the prevalence of electronic cigarette use among counseled tobacco users admitted to 2 academic hospitals.

Methods: Cross-sectional data of hospitalized adult tobacco users who were admitted between January 1, 2015 and December 31, 2015 and who received bedside tobacco cessation counseling from a tobacco treatment service counselor were examined.

From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making.

Objective: This study aimed to gather qualitative feedback on patient perceptions of informed consent forms and elicit recommendations to improve readability and utility for enhanced patient safety and engagement in shared decision making.

Methods: Sixty interviews in personal interviews were conducted consisting of a literacy and numeracy assessment, a comprehension quiz to assess retention of key information, and open-ended questions to determine reactions, clarity of information, and suggestions for improvement.

Results: Although 68% of the participants had education beyond high school, many still missed comprehension questions and found the forms difficult to read.

Embedding a trauma hospitalist in the trauma service reduces mortality and 30-day trauma-related readmissions.

Background: Recognizing the increasing age and comorbid conditions of patients admitted to our trauma service, we embedded a hospitalist on the trauma service at our Level I trauma center.This program was initiated in January 2013. This study was designed to investigate differences in outcomes between trauma patients who received care from the trauma hospitalist (THOSP) program and similarly medically complex trauma patients who did not receive THOSP care.

Increasing the efficiency of a targeted methicillin-resistant Staphylococcus aureus screening program.

An interdisciplinary team implemented a screening program targeting patients with a history of methicillin-resistant Staphylococcus aureus (MRSA), to reduce unnecessary contact isolation. After converting from a 2-step culture-based protocol to single polymerase chain reaction (PCR) testing, we increased the efficiency of the screening program from 77% to 100%. Despite the higher cost of PCR-based testing, this program remained cost-saving.

Using a Lean Six Sigma Approach to Yield Sustained Pressure Ulcer Prevention for Complex Critical Care Patients.

Background: Under value-based purchasing, Medicare withholds reimbursements for hospital-acquired pressure ulcer occurrence and rewards hospitals that meet performance standards. With little evidence of a validated prevention process, nurse managers are challenged to find evidence-based interventions.

Objective: The aim of this study was to reduce the unit-acquired pressure ulcer (UAPU) rate on targeted intensive care and step-down units by 15% using Lean Six Sigma (LSS) methodology.