Approaches to Evaluating Digital Health Technologies: Scoping Review.

BACKGROUND: Profound scientific evaluation of novel digital health technologies (DHTs) is key to enhance successful development and implementation. As such, we previously developed the eHealth evaluation cycle. The eHealth evaluation cycle contains 5 consecutive study phases: conceptual, development, feasibility, effectiveness, and implementation. OBJECTIVE: The aim of this study is to develop a better understanding of the daily practice of the eHealth evaluation cycle. Therefore, the objectives are to conduct a structured analysis of literature data to analyze the practice of the evaluation study phases and to determine which evaluation approaches are used in which study phase of the eHealth evaluation cycle. METHODS: We conducted a systematic literature search in PubMed including the MeSH term "telemedicine" in combination with a wide variety of evaluation approaches. Original peer-reviewed studies published in the year 2019 (pre-COVID-19 cohort) were included. Nonpatient-focused studies were excluded. Data on the following variables were extracted and systematically analyzed: journal, country, publication date, medical specialty, primary user, functionality, evaluation study phases, and evaluation approach. RStudio software was used to summarize the descriptive data and to perform statistical analyses. RESULTS: We included 824 studies after 1583 titles and abstracts were screened. The majority of the evaluation studies focused on the effectiveness (impact; 304/824, 36.9%) study phase, whereas uptake (implementation; 70/824, 8.5%) received the least focus. Randomized controlled trials (RCTs; 170/899, 18.9%) were the most commonly used DHT evaluation method. Within the effectiveness (impact) study phase, RCTs were used in one-half of the studies. In the conceptual and planning phases, survey research (27/78, 35%) and interview studies (27/78, 35%) were most frequently used. The United States published the largest amount of DHT evaluation studies (304/824, 36.9%). Psychiatry and mental health (89/840, 10.6%) and cardiology (75/840, 8.9%) had the majority of studies published within the field. CONCLUSIONS: We composed the first comprehensive overview of the actual practice of implementing consecutive DHT evaluation study phases. We found that the study phases of the eHealth evaluation cycle are unequally studied and most attention is paid to the effectiveness study phase. In addition, the majority of the studies used an RCT design. However, in order to successfully develop and implement novel DHTs, stimulating equal evaluation of the sequential study phases of DHTs and selecting the right evaluation approach that fits the iterative nature of technology might be of the utmost importance.

Implementation and Scale-up of Telemonitoring in the Netherlands.

The healthcare system requires reforms for equitable and sustainable care. Telemonitoring offers a solution, yet its implementation lacks research. In the Netherlands, University Medical Centers (UMCs) lead healthcare transformation through the Citrien-2 network, scaling up three telemonitoring programs from 2020 to 2022. An uncontrolled before-after study design was used to evaluate upscaling. Primary outcomes focused on telemonitoring normalization using the Normalisation Process Theory (NoMAD). Secondary outcomes included patient uptake and qualitative analyses. Results show implementation across projects and UMCs, with overall increased patient uptake. Healthcare professionals perceive telemonitoring positively, but challenges persist in integrating it into workflows. Continuous assessment is crucial for addressing implementation complexities and maximizing telemonitoring's impact on healthcare delivery.

Embedding Ethics in the Implementation of a Vital Sign Monitoring Technology.

The implementation of wireless continuous vital sign monitoring (CVSM) technologies changes daily care practices of healthcare professionals, which gives rise to unknown new roles and responsibilities. In this paper we present a study on how we combine the disciplines of medical informatics and ethics in the implementation of the Philips Healthdot, a smart patch for remote CVSM. The aim of this study is to investigate experiences and perspectives on the support levels and roles and responsibilities associated with the integration of smart patches, by conducting interviews with nurses. This interdisciplinary study gives insights into the technological, organizational, and ethical concerns surrounding the implementation of CVSM in healthcare. The findings and analytical approach may provide valuable insights for researching the appropriate implementation of digital health technologies.

The National Coordinated Citrien eHealth Program to Scale Up Telemonitoring: Protocol for a Before-and-After Evaluation Study.

BACKGROUND: Sustainable implementation of telemonitoring in health care is challenging, especially if one aims to scale up telemonitoring initiatives nationwide. The National collaborative eHealth program in the Netherlands is supporting the nationwide upscaling of telemonitoring in 3 clinical domains by implementing telemonitoring in all Dutch university medical centers (UMCs). The chosen telemonitoring concepts are (1) telemonitoring solutions in the domain of cardiology, (2) telemonitoring solutions providing care from a distance in obstetrics, and (3) telemonitoring solutions monitoring vital functions in hospital wards. OBJECTIVE: The aim of this study is to evaluate the upscaling of telemonitoring in Dutch university hospitals in order to gain a better knowledge of the process, methods, and outcomes of nationwide upscaling strategies. Our hypothesis is that by the completion of the Citrien program's scale-up, telemonitoring will be operational in all UMCs but not normalized in routine care. METHODS: A before-and-after study will be conducted to assess upscaling. The theoretical frameworks used are the framework for nonadoption, abandonment, scale-up, spread, and sustainability; the Normalization Process Theory; and a project management tool Project Canvas. The primary outcome of the study is the degree of normalization to which health care providers at UMCs consider telemonitoring a part of their routine practice, measured using the Normalization MeAsurement Development tool (NoMAD). Our secondary outcome is the uptake of telemonitoring at the Dutch UMCs, using management data from UMCs' business intelligence systems query. RESULTS: Data will be collected between May 2020 and December 2022. Results were retrieved in June 2023. UMCs' business intelligence systems are queried for data for the secondary outcome measures. There is a risk that the UMCs will not be able to provide this management information. The laws and regulations governing telemonitoring in the Netherlands are changing, with the Electronic Data Exchange in Health Care Act (Wet elektronische gegevensuitwisseling in de zorg) and the European Health Data Space Act expected to positively influence implementation and upscaling. CONCLUSIONS: The Citrien program is a nationally coordinated change management program that is scaling up telemonitoring across contexts and settings. This study will produce original data on the uptake and upscaling of telemonitoring at Dutch UMCs. Future initiatives to implement eHealth in the health care sector may be guided by the wide range of success factors, obstacles, and experiences collected through this program. The network itself may be of great value impacting future acceleration of eHealth initiatives. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45201.

Enablers and barriers in upscaling telemonitoring across geographic boundaries: a scoping review.

INTRODUCTION AND OBJECTIVE: Telemonitoring is a method to monitor a person's vital functions via their physiological data at distance, using technology. While pilot studies on the proposed benefits of telemonitoring show promising results, it appears challenging to implement telemonitoring on a larger scale. The aim of this scoping review is to identify the enablers and barriers for upscaling of telemonitoring across different settings and geographical boundaries in healthcare. METHODS: PubMed, Embase, Cinahl, Web of Science, ProQuest and IEEE databases were searched. Resulting outcomes were assessed by two independent reviewers. Studies were considered eligible if they focused on remote monitoring of patients' vital functions and data was transmitted digitally. Using scoping review methodology, selected studies were systematically assessed on their factors of influence on upscaling of telemonitoring. RESULTS: A total of 2298 titles and abstracts were screened, and 19 articles were included for final analysis. This analysis revealed 89 relevant factors of influence: 26 were reported as enabler, 18 were reported as barrier and 45 factors were reported being both. The actual utilisation of telemonitoring varied widely across studies. The most frequently mentioned factors of influence are: resources such as costs or reimbursement, access or interface with electronic medical record and knowledge of frontline staff. CONCLUSION: Successful upscaling of telemonitoring requires insight into its critical success factors, especially at an overarching national level. To future-proof and facilitate upscaling of telemonitoring, it is recommended to use this type of technology in usual care and to find means for reimbursement early on. A wide programme on change management, nationally or regionally coordinated, is key. Clear regulatory conditions and professional guidelines may further facilitate widespread adoption and use of telemonitoring. Future research should focus on converting the 'enablers and barriers' as identified by this review into a guideline supporting further nationwide upscaling of telemonitoring.

Production Time and User Satisfaction of 3-Dimensional Printed Orthoses For Chronic Hand Conditions Compared With Conventional Orthoses: A Prospective Case Series.

OBJECTIVE: Hand orthoses are often prescribed for persons with chronic hand and wrist impairments. This study assessed the feasibility, in terms of production time and user satisfaction, of 3-dimensional printed hand orthoses compared with conventional hand orthoses for this population. METHODS: In this prospective case series, both a conventional hand orthosis and a 3-dimensional printed hand orthosis were manufactured for 10 participants. Production time (in minutes) of each orthosis was recorded. Each orthosis was worn for one week, after which participants completed a self-designed questionnaire on satisfaction, scored on a 5-point Likert scale. Functionality and orthosis preference were also assessed. RESULTS: The mean (standard deviation (SD)) production time for the 3-dimensional printed orthoses, of 112 (11.0) min, was significantly shorter compared with 239 (29.2) min for the conventional orthoses (95% confidence interval (95% CI) 71-182 min, p = 0.001). Satisfaction scores were similar for both orthoses, except for comfort item "fitting method", which was rated significantly higher for scanning compared with casting (median [IQR] score: 5 [0.0]; 4 [2.0], p = 0.034). Functionality and orthosis preference were rated similar for both orthoses. CONCLUSION: As the production time was halved, user satisfaction similar, and scanning experienced as slightly more comfortable than casting, 3-dimensional printed hand orthoses seem feasible and potentially beneficial for use in people with chronic hand and wrist impairments.

Awake Proning as an Adjunctive Therapy for Refractory Hypoxemia in Non-Intubated Patients with COVID-19 Acute Respiratory Failure: Guidance from an International Group of Healthcare Workers.

Non-intubated patients with acute respiratory failure due to COVID-19 could benefit from awake proning. Awake proning is an attractive intervention in settings with limited resources, as it comes with no additional costs. However, awake proning remains poorly used probably because of unfamiliarity and uncertainties regarding potential benefits and practical application. To summarize evidence for benefit and to develop a set of pragmatic recommendations for awake proning in patients with COVID-19 pneumonia, focusing on settings where resources are limited, international healthcare professionals from high and low- and middle-income countries (LMICs) with known expertise in awake proning were invited to contribute expert advice. A growing number of observational studies describe the effects of awake proning in patients with COVID-19 pneumonia in whom hypoxemia is refractory to simple measures of supplementary oxygen. Awake proning improves oxygenation in most patients, usually within minutes, and reduces dyspnea and work of breathing. The effects are maintained for up to 1 hour after turning back to supine, and mostly disappear after 6-12 hours. In available studies, awake proning was not associated with a reduction in the rate of intubation for invasive ventilation. Awake proning comes with little complications if properly implemented and monitored. Pragmatic recommendations including indications and contraindications were formulated and adjusted for resource-limited settings. Awake proning, an adjunctive treatment for hypoxemia refractory to supplemental oxygen, seems safe in non-intubated patients with COVID-19 acute respiratory failure. We provide pragmatic recommendations including indications and contraindications for the use of awake proning in LMICs.

The ClaudicatioNet concept: design of a national integrated care network providing active and healthy aging for patients with intermittent claudication.

INTRODUCTION: Intermittent claudication (IC) is a manifestation of peripheral arterial occlusive disease (PAOD). Besides cardiovascular risk management, supervised exercise therapy (SET) should be offered to all patients with IC. Outdated guidelines, an insufficient number of specialized physiotherapists (PTs), lack of awareness of the importance of SET by referring physicians, and misguided financial incentives all seriously impede the availability of a structured SET program in The Netherlands. DESCRIPTION OF CARE PRACTICE: By initiating regional care networks, ClaudicatioNet aims to improve the quality of care for patients with IC. Based on the chronic care model as a conceptual framework, these networks should enhance the access, continuity, and (cost) efficiency of the health care system. With the aid of a national database, health care professionals will be able to benchmark patient results while ClaudicatioNet will be able to monitor quality of care by way of functional and patient reported outcome measures. DISCUSSION: The success of ClaudicatioNet is dependent on several factors. Vascular surgeons, general practitioners and coordinating central caregivers will need to team up and work in close collaboration with specialized PTs. A substantial task in the upcoming years will be to monitor the quality, volume, and distribution of ClaudicatioNet PTs. Finally, misguided financial incentives within the Dutch health care system need to be tackled. CONCLUSION: With ClaudicatioNet, integrated care pathways are likely to improve in the upcoming years. This should result in the achievement of optimal quality of care for all patients with IC.