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. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

Quality Improvement on the Long-term Care Ventilator Unit: Interventions to Increase Patient Safety and Prevent Patient Harm

BACKGROUND: Tracheostomy patients are susceptible to life-threatening emergencies when their airways are compromised. Epidemiologic data suggests that 3.2% to 30% of tracheostomy patents have a complication. The long-term care ventilator unit (LTCVU) is a 25-bed unit in a nursing home. It has noted that 40% of patients have a complication. A group of hospitals demonstrated a 90% reduction in complications through five interventions. METHODS: The Johns Hopkins Nursing Evidence-Based Practice model was utilized to take the Global Tracheostomy Collaborative interventions and apply them to the LTCVU with the aim of reducing the number of airway complications on the unit by 50%. INTERVENTIONS: Five interventions were implemented for this quality improvement project: Bedside multidisciplinary team rounds, nursing in-services, continued protocolization of care, tracking complication rates and active prevention measures. Pre- and post-education surveys were distributed to nurses. Pre-education surveys averaged a 49% score, while the post-education average was 98%. RESULTS: Complications per patient per day were tracked pre- and post-intervention and a control chart compared pre- and post-intervention rates. Pre-implementation there were 0.00655 complications per patient per day over 22-weeks. Post-implementation there were 0.01012 complications per patient per day over 6-weeks. CONCLUSIONS: While complication rates seem to have increased following implementation, there are many reasons that an increase may have been noted. During implementation, census increased while staffing did not. Additionally, the project was implemented during the winter season, when dry air often causes increased mucous plugging. Finally, the post-implementation period has only covered six weeks. Perhaps with extended monitoring, rates would decrease

Improving the clinical value and utility of CGM systems: issues and recommendations : a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM data to make therapeutic decisions. This scientific statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

Improving the clinical value and utility of CGM systems: issues and recommendations: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

Development and Performance Evaluation of a Connected Vehicle Application Development Platform (CVDeP)

Connected vehicle (CV) application developers need a development platform to build, test and debug real-world CV applications, such as safety, mobility, and environmental applications, in edge-centric cyber-physical systems. Our study objective is to develop and evaluate a scalable and secure CV application development platform (CVDeP) that enables application developers to build, test and debug CV applications in realtime. CVDeP ensures that the functional requirements of the CV applications meet the corresponding requirements imposed by the specific applications. We evaluated the efficacy of CVDeP using two CV applications (one safety and one mobility application) and validated them through a field experiment at the Clemson University Connected Vehicle Testbed (CU-CVT). Analyses prove the efficacy of CVDeP, which satisfies the functional requirements (i.e., latency and throughput) of a CV application while maintaining scalability and security of the platform and applications

Best practice in undertaking and reporting health technology assessments : Working Group 4 report

[Executive Summary] The aim of Working Group 4 has been to develop and disseminate best practice in undertaking and reporting assessments, and to identify needs for methodologic development. Health technology assessment (HTA) is a multidisciplinary activity that systematically examines the technical performance, safety, clinical efficacy, and effectiveness, cost, costeffectiveness, organizational implications, social consequences, legal, and ethical considerations of the application of a health technology (18). HTA activity has been continuously increasing over the last few years. Numerous HTA agencies and other institutions (termed in this report “HTA doers”) across Europe are producing an important and growing amount of HTA information. The objectives of HTA vary considerably between HTA agencies and other actors, from a strictly political decision making–oriented approach regarding advice on market licensure, coverage in benefits catalogue, or investment planning to information directed to providers or to the public. Although there seems to be broad agreement on the general elements that belong to the HTA process, and although HTA doers in Europe use similar principles (41), this is often difficult to see because of differences in language and terminology. In addition, the reporting of the findings from the assessments differs considerably. This reduces comparability and makes it difficult for those undertaking HTA assessments to integrate previous findings from other HTA doers in a subsequent evaluation of the same technology. Transparent and clear reporting is an important step toward disseminating the findings of a HTA; thus, standards that ensure high quality reporting may contribute to a wider dissemination of results. The EUR-ASSESS methodologic subgroup already proposed a framework for conducting and reporting HTA (18), which served as the basis for the current working group. New developments in the last 5 years necessitate revisiting that framework and providing a solid structure for future updates. Giving due attention to these methodologic developments, this report describes the current “best practice” in both undertaking and reporting HTA and identifies the needs for methodologic development. It concludes with specific recommendations and tools for implementing them, e.g., by providing the structure for English-language scientific summary reports and a checklist to assess the methodologic and reporting quality of HTA reports