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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.

Health technologies to monitor glucose values are an important part of daily diabetes self-care. Based on 12 months of fieldwork in Denmark with 14 people with type 2 diabetes, I explore people\'s experience of living with Continuous Glucose Monitoring. This new technology automatically measures glucose levels throughout the day but is not yet common in type 2 diabetes treatment in Denmark. In this article, I capture the social shaping of Continuous Glucose Monitoring, employing the concept of time. I show how adoption of the technology is embedded in a form of biographical time. This refers to people\'s use of the technology linked to their stories about themselves. Drawing on a notion of habitus, people\'s embodied past experiences and future prospects come to shape its use, I propose. My main claim is that while people with diabetes implement the technology into their lives in unique ways, adapting it to their circumstances and social conditions, practice of Continuous Glucose Monitoring reproduce social structures. This is evinced, I argue, in people\'s tinkering with the technology and the frames of reference used to inform it. I introduce the term \"tinkering in time\", highlighting the introduction of new health technology within the frame of lived human time.

BACKGROUND: The use of artificial intelligence (AI) for pain assessment has the potential to address historical challenges in infant pain assessment. There is a dearth of information on the perceived benefits and barriers to the implementation of AI for neonatal pain monitoring in the neonatal intensive care unit (NICU) from the perspective of health care professionals (HCPs) and parents. This qualitative analysis provides novel data obtained from 2 large tertiary care hospitals in Canada and the United Kingdom.
OBJECTIVE: The aim of the study is to explore the perspectives of HCPs and parents regarding the use of AI for pain assessment in the NICU.
METHODS: In total, 20 HCPs and 20 parents of preterm infants were recruited and consented to participate from February 2020 to October 2022 in interviews asking about AI use for pain assessment in the NICU, potential benefits of the technology, and potential barriers to use.
RESULTS: The 40 participants included 20 HCPs (17 women and 3 men) with an average of 19.4 (SD 10.69) years of experience in the NICU and 20 parents (mean age 34.4, SD 5.42 years) of preterm infants who were on average 43 (SD 30.34) days old. Six themes from the perspective of HCPs were identified: regular use of technology in the NICU, concerns with regard to AI integration, the potential to improve patient care, requirements for implementation, AI as a tool for pain assessment, and ethical considerations. Seven parent themes included the potential for improved care, increased parental distress, support for parents regarding AI, the impact on parent engagement, the importance of human care, requirements for integration, and the desire for choice in its use. A consistent theme was the importance of AI as a tool to inform clinical decision-making and not replace it.
CONCLUSIONS: HCPs and parents expressed generally positive sentiments about the potential use of AI for pain assessment in the NICU, with HCPs highlighting important ethical considerations. This study identifies critical methodological and ethical perspectives from key stakeholders that should be noted by any team considering the creation and implementation of AI for pain monitoring in the NICU.

BACKGROUND: Electronic health record-based clinical decision support (CDS) tools can facilitate the adoption of evidence into practice. Yet, the impact of CDS beyond single-site implementation is often limited by dissemination and implementation barriers related to site- and user-specific variation in workflows and behaviors. The translation of evidence-based CDS from initial development to implementation in heterogeneous environments requires a framework that assures careful balancing of fidelity to core functional elements with adaptations to ensure compatibility with new contexts.
OBJECTIVE: This study aims to develop and apply a framework to guide tailoring and implementing CDS across diverse clinical settings.
METHODS: In preparation for a multisite trial implementing CDS for pediatric overweight or obesity in primary care, we developed the User-Centered Framework for Implementation of Technology (UFIT), a framework that integrates principles from user-centered design (UCD), human factors/ergonomics theories, and implementation science to guide both CDS adaptation and tailoring of related implementation strategies. Our transdisciplinary study team conducted semistructured interviews with pediatric primary care clinicians and a diverse group of stakeholders from 3 health systems in the northeastern, midwestern, and southeastern United States to inform and apply the framework for our formative evaluation.
RESULTS: We conducted 41 qualitative interviews with primary care clinicians (n=21) and other stakeholders (n=20). Our workflow analysis found 3 primary ways in which clinicians interact with the electronic health record during primary care well-child visits identifying opportunities for decision support. Additionally, we identified differences in practice patterns across contexts necessitating a multiprong design approach to support a variety of workflows, user needs, preferences, and implementation strategies.
CONCLUSIONS: UFIT integrates theories and guidance from UCD, human factors/ergonomics, and implementation science to promote fit with local contexts for optimal outcomes. The components of UFIT were used to guide the development of Improving Pediatric Obesity Practice Using Prompts, an integrated package comprising CDS for obesity or overweight treatment with tailored implementation strategies.
BACKGROUND: ClinicalTrials.gov NCT05627011; https://clinicaltrials.gov/study/NCT05627011.

BACKGROUND: Digital health technologies offer the potential to improve the daily lives of older adults, maintain their health efficiently, and allow aging in place. Despite increasing evidence of benefits and advantages, readiness for adopting digital interventions among older people remains underexplored.
OBJECTIVE: This study aims to explore the relationships between sociodemographic-, health-, and lifestyle-related factors and technology use in everyday life and community-dwelling older adults\' readiness to adopt telemedicine, smartphones with texting apps, wearables, and robotics.
METHODS: This was a cross-sectional, population-based survey study with a stratified probabilistic sample of adults aged 75 years or older living in South Tyrol (autonomous province of Bolzano/Bozen, Italy). A random sample of 3600 community-dwelling older adults living at home was invited to complete a questionnaire including single items (older adults\' readiness to use health technology) and scales (PRISMA-7; Program of Research on Integration of Services for the Maintenance of Autonomy). Descriptive and logistic regression analyses were performed to analyze the data.
RESULTS: In total, 1695 community-dwelling older adults completed the survey (for a response rate of 47%). In terms of potential digital health technology adoption, wearable devices were favored by 33.7% (n=571), telemedicine by 30.1% (n=510), smartphones and texting apps by 24.5% (n=416), and assistant robots by 13.7% (n=232). Sociodemographic-, health- and lifestyle-related factors, as well as the use of technology in everyday life, played a significant role in explaining readiness to adopt digital health technologies. For telemedicine, age ≥85 years (odds ratio [OR] 0.74, 95% CI 0.56-0.96), financial constraints (OR 0.68, 95% CI 0.49-0.95), and less than 2 hours of physical activity per week (OR 0.75, 95% CI 0.58-0.98) were associated with nonreadiness, while Italian-speaking participants (OR 1.54, 95% CI 1.16-2.05) and those regularly using computers (OR 1.74, 95% CI 1.16-2.60), smartphones (OR 1.69, 95% CI 1.22-2.35), and the internet (OR 2.26, 95% CI 1.47-3.49) reported readiness for adoption.
CONCLUSIONS: Community-dwelling older adults display varied readiness toward the adoption of digital health technologies, influenced by age, mother tongue, living situation, financial resources, physical activity, and current use of technology. The findings underscore the need for tailored interventions and educational programs to boost digital health technology adoption among community-dwelling older adults.

UNASSIGNED: The development of prototypes capable of intervening in the area of rehabilitation in physical therapy clinical practice activities that were previously carried out in a traditional way, that is, manually, demonstrates how technology is having an impact on professional careers such as physiotherapy.
UNASSIGNED: The purpose of this study is to present a comprehensive examination of various technologies employed in the facilitation of patient rehabilitation, with a focus on their potential integration within the clinical practice of physical therapists.
UNASSIGNED: We conducted a systematic search in four electronic databases (CINAHL, Embase, PEDro, and PubMed) for research on rehabilitation technologies. The eligible studies should demonstrate a clear utilization of technology in various aspects of the clinical approach to the rehabilitation process and have been published between 2000 and 2021 in either Portuguese or English.
UNASSIGNED: A total of 18 articles that satisfied the selection criteria were included in the study. The studies were classified into four distinct categories of rehabilitation technologies, which were determined by the specific characteristics of the technology employed and its integration with the therapeutic approach to rehabilitation. These categories include digital technologies, artificial intelligence and/or robotics, virtual technologies, and hybrid technologies.
UNASSIGNED: Rehabilitation technologies possess the capacity to effectively facilitate clinical activities performed by physical therapy professionals, including injury prevention, movement monitoring, and coordination of rehabilitation programs, with minimal or negligible intervention from the physical therapist. Further research is required to ascertain the precise capabilities of various technologies in collaborating with physiotherapists to deliver comprehensive care for patients\' physical well-being, encompassing both therapeutic and preventive approaches.
UNASSIGNED: PROSPERO registration number CRD42020222288.

In the pharmaceutical sector, evergreening is considered a range of practices applied to extend monopoly protection on existing products. Filing several patent applications related to the same active pharmaceutical ingredient (API) is one of the most common manifestations of evergreening. During the COVID-19 pandemic, several health technologies were developed. This study aimed to analyze the extension of evergreening for selected health technologies for SARS-CoV-2 through patent filing strategies. Starting with the selection of three antivirals, one biological and two vaccines, a patent landscape was built based on public and private databases. Regarding these selected technologies, we analyzed some of the evergreening strategies used by different applicants, academic institutions or pharmaceutical companies and found a total of 29 applications (10 after the pandemic) for antivirals, 3 applications for a biological drug (1 after the pandemic), and 41 applications for vaccines (23 after the pandemic). Despite differences among the technologies, a common aspect found in all analyzed cases is the intense patent filing after the pandemic, aligned to the fact that those technologies were moving through the R&D process up to regulatory approval. The evergreening approach pursued has already been found in other diseases, with the risk of monopoly extension and also bringing legal uncertainty due to the lack of transparency of newer patent applications covering specific medical indications. Therefore, efforts to address evergreening should be pursued by countries, including the adoption of a public health approach to the patent examination of those technologies to prevent the granting of undeserved patents.

We developed an algorithm to explore unexpected growth in the usage and costs of health technologies. We exploit data from the expenditures on technologies funded by the Colombian government under the compulsory insurance system, where all prescriptions for technologies not included in an explicit list must be registered in a centralized information system, covering the period from 2017 to 2022. The algorithm consists of two steps: an outlier detection method based on the density of the expenditures for selecting a first set of technologies to consider (39 technologies out of 106,957), and two anomaly detection models for time series to determine which insurance companies, health providers, and regions have the most notorious increases. We have found that most medicines associated with atypical behavior and significant monetary growth could be linked to the use of recently introduced drugs in the market. These drugs have valid patents and very specific clinical indications, often involving high-cost pharmacological treatments. The most relevant case is the Burosumab, approved in 2018 to treat a rare genetic disorder affecting skeletal growth. Secondly, there is clear evidence of anomalous increasing trend evolutions in the identified enteral nutritional support supplements or Food for Special Medical Purposes. The health system did not purchase these products before July 2021, but in 2022 they represented more than 500,000 USD per month.

Rare diseases affect a small number of people compared to prevalent diseases. The vast majority of these diseases are of genetic origin, have no cure, are chronic and can lead to death. Although the right to access medicines is included in the constitutionally guaranteed right to health in Brazil, problems in the supply of medicines for rare diseases are reported in the country. This study aimed to describe and analyse the initiatives to promote access to medicines for treating rare diseases in the Unified Health System, Brazil, after the publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases. Based on the model published by the WHO Regional Office for Europe, which described access to medicines in prelaunch, perilaunch and postlaunch policies, the initiatives referring to each category were summarized based on documentary research searched in online databases from January 2014 to December 2020.
Different actions and policy interventions were identified, which went through the expansion of resources for research and development, health regulations, incorporation of new drugs, review and publication of clinical guidelines, and expansion of the network of care facilities by the Ministry of Health. On the other hand, aspects related to care policies, pricing methods, technological development, and development of pharmaceutical service processes were not implemented.
Although it is impossible to determine the explicit motivation of such actions concerning the Policy, its publication certainly was a landmark in Brazilian society, allowing greater recognition of the needs of rare disease patients and the specificities of treatment\'. However, this study suggests that the steps that make up the life cycle of medicines are not linked, lacking articulation and integration of the care network, and consequently, there is no evidence that rare disease policy publication has generated a broad impact on the promotion of access to medicines to treat rare diseases in Brazil.