Guidelines for the development, performance evaluation and validation of new sleep technologies (DEVSleepTech guidelines) - a protocol for a Delphi consensus study.

New sleep technologies are being developed, refined and delivered at a fast pace. However, there are serious concerns about the validation and accuracy of new sleep-related technologies being made available, as many of them, especially consumer-sleep technologies, have not been tested in comparison with gold-standard methods or have been approved by health regulatory agencies. The importance of proper validation and performance evaluation of new sleep technologies has already been discussed in previous studies and some recommendations have already been published, but most of them do not employ standardized methodology and are not able to cover all aspects of new sleep technologies. The current protocol describes the methods of a Delphi consensus study to create guidelines for the development, performance evaluation and validation of new sleep devices and technologies. The resulting recommendations are not intended to be used as a quality assessment tool to evaluate individual articles, but rather to evaluate the overall procedures, studies and experiments performed to develop, evaluate performance and validate new technologies. We hope these guidelines can be helpful for researchers who work with new sleep technologies on the appraisal of their reliability and validation, for companies who are working on the development and refinement of new sleep technologies, and by regulatory agencies to evaluate new technologies that are looking for registration, approval or inclusion on health systems.

A comprehensive survey of artificial intelligence adoption in European laboratory medicine: current utilization and prospects.

BACKGROUND: As the healthcare sector evolves, Artificial Intelligence's (AI's) potential to enhance laboratory medicine is increasingly recognized. However, the adoption rates and attitudes towards AI across European laboratories have not been comprehensively analyzed. This study aims to fill this gap by surveying European laboratory professionals to assess their current use of AI, the digital infrastructure available, and their attitudes towards future implementations. METHODS: We conducted a methodical survey during October 2023, distributed via EFLM mailing lists. The survey explored six key areas: general characteristics, digital equipment, access to health data, data management, AI advancements, and personal perspectives. We analyzed responses to quantify AI integration and identify barriers to its adoption. RESULTS: From 426 initial responses, 195 were considered after excluding incomplete and non-European entries. The findings revealed limited AI engagement, with significant gaps in necessary digital infrastructure and training. Only 25.6 % of laboratories reported ongoing AI projects. Major barriers included inadequate digital tools, restricted access to comprehensive data, and a lack of AI-related skills among personnel. Notably, a substantial interest in AI training was expressed, indicating a demand for educational initiatives. CONCLUSIONS: Despite the recognized potential of AI to revolutionize laboratory medicine by enhancing diagnostic accuracy and efficiency, European laboratories face substantial challenges. This survey highlights a critical need for strategic investments in educational programs and infrastructure improvements to support AI integration in laboratory medicine across Europe. Future efforts should focus on enhancing data accessibility, upgrading technological tools, and expanding AI training and literacy among professionals. In response, our working group plans to develop and make available online training materials to meet this growing educational demand.

Attitudes Toward and Use of eHealth Technologies Among German Dermatologists: Repeated Cross-Sectional Survey in 2019 and 2021.

BACKGROUND: In recent years, legal and infrastructural conditions have been set to improve the adoption of digital applications in health care in Germany. The impact of these actions was amplified by the COVID-19 pandemic. So far, no studies have confirmed this progress in dermatology. OBJECTIVE: The aim of this study was to measure changes in knowledge, interest, expectation, and use of digital applications in health care among dermatologists in Germany in 2019 and 2021. METHODS: We administered a repeated cross-sectional survey among dermatologists in medical practices and clinics in Germany at 2 time points: t1 (2019; before the COVID-19 pandemic) and t2 (2021; during the COVID-19 pandemic). We used a standardized questionnaire, including items on respondents' knowledge, interest, expectation, and use of digital applications, as well as their demographics. The survey was distributed by post and email. The data were analyzed descriptively as well as with multiple logistic regressions. RESULTS: At t1, 585 (272/571, 47.6% female; mean age 52.4, SD 8.9 years) dermatologists and at t2, 792 (360/736, 48.9% female; mean age 54.3, SD 8.6 years) dermatologists participated in this survey. Interest in digital medicine was higher at t1 than at t2 (381/585, 65.1% vs 458/792, 57.8%; P≤.001). Nevertheless, 38.6% (306/792) had used digital applications more often since the beginning of the pandemic. For example, real-time telemedicine with patients (12/585, 2.1% vs 160/792, 7.6%; P≤.001) and other specialists did increase (33/385, 5.7% vs 181/792, 22.8%; P≤.001). Almost one-third expressed great concerns about digitalization (272/792, 34.3% vs 294/792, 37.1%; P=.21). Spatial analysis revealed higher interest in, more positive expectations toward, and higher use of digital applications in urban areas in comparison to rural areas. For instance, dermatologists from urban areas assessed future applications as having less risk (adjusted odds ratio [aOR] 0.51, 95% CI 0.35-0.76) than did dermatologists from rural areas. The situation was similar with the age groups, as, for example, dermatologists aged <50 years also expected lower risks (aOR 0.51, 95% CI 0.34-0.77) than those aged ≥50 years. There were no differences between sexes in use, but there were differences in knowledge and expectation; for example, male participants assessed their confidence in using digital applications as higher (aOR 1.44, 95% CI 1.01-2.04) than did female participants. CONCLUSIONS: During the pandemic, the use of digital applications in dermatology increased but still remained at a moderate level. The regional and age-related disparities identified indicate the need for further action to ensure equal access to digital care.

Public and Research Interest in Telemedicine From 2017 to 2022: Infodemiology Study of Google Trends Data and Bibliometric Analysis of Scientific Literature.

BACKGROUND: Telemedicine offers a multitude of potential advantages, such as enhanced health care accessibility, cost reduction, and improved patient outcomes. The significance of telemedicine has been underscored by the COVID-19 pandemic, as it plays a crucial role in maintaining uninterrupted care while minimizing the risk of viral exposure. However, the adoption and implementation of telemedicine have been relatively sluggish in certain areas. Assessing the level of interest in telemedicine can provide valuable insights into areas that require enhancement. OBJECTIVE: The aim of this study is to provide a comprehensive analysis of the level of public and research interest in telemedicine from 2017 to 2022 and also consider any potential impact of the COVID-19 pandemic. METHODS: Google Trends data were retrieved using the search topics "telemedicine" or "e-health" to assess public interest, geographic distribution, and trends through a joinpoint regression analysis. Bibliographic data from Scopus were used to chart publications referencing the terms "telemedicine" or "eHealth" (in the title, abstract, and keywords) in terms of scientific production, key countries, and prominent keywords, as well as collaboration and co-occurrence networks. RESULTS: Worldwide, telemedicine generated higher mean public interest (relative search volume=26.3%) compared to eHealth (relative search volume=17.6%). Interest in telemedicine remained stable until January 2020, experienced a sudden surge (monthly percent change=95.7%) peaking in April 2020, followed by a decline (monthly percent change=-22.7%) until August 2020, and then returned to stability. A similar trend was noted in the public interest regarding eHealth. Chile, Australia, Canada, and the United States had the greatest public interest in telemedicine. In these countries, moderate to strong correlations were evident between Google Trends and COVID-19 data (ie, new cases, new deaths, and hospitalized patients). Examining 19,539 original medical articles in the Scopus database unveiled a substantial rise in telemedicine-related publications, showing a total increase of 201.5% from 2017 to 2022 and an average annual growth rate of 24.7%. The most significant surge occurred between 2019 and 2020. Notably, the majority of the publications originated from a single country, with 20.8% involving international coauthorships. As the most productive country, the United States led a cluster that included Canada and Australia as well. European, Asian, and Latin American countries made up the remaining 3 clusters. The co-occurrence network categorized prevalent keywords into 2 clusters, the first cluster primarily focused on applying eHealth, mobile health (mHealth), or digital health to noncommunicable or chronic diseases; the second cluster was centered around the application of telemedicine and telehealth within the context of the COVID-19 pandemic. CONCLUSIONS: Our analysis of search and bibliographic data over time and across regions allows us to gauge the interest in this topic, offer evidence regarding potential applications, and pinpoint areas for additional research and awareness-raising initiatives.

Insights From a Clinically Orientated Workshop on Health Care Cybersecurity and Medical Technology: Observational Study and Thematic Analysis.

BACKGROUND: Health care professionals receive little training on the digital technologies that their patients rely on. Consequently, practitioners may face significant barriers when providing care to patients experiencing digitally mediated harms (eg, medical device failures and cybersecurity exploits). Here, we explore the impact of technological failures in clinical terms. OBJECTIVE: Our study explored the key challenges faced by frontline health care workers during digital events, identified gaps in clinical training and guidance, and proposes a set of recommendations for improving digital clinical practice. METHODS: A qualitative study involving a 1-day workshop of 52 participants, internationally attended, with multistakeholder participation. Participants engaged in table-top exercises and group discussions focused on medical scenarios complicated by technology (eg, malfunctioning ventilators and malicious hacks on health care apps). Extensive notes from 5 scribes were retrospectively analyzed and a thematic analysis was performed to extract and synthesize data. RESULTS: Clinicians reported novel forms of harm related to technology (eg, geofencing in domestic violence and errors related to interconnected fetal monitoring systems) and barriers impeding adverse event reporting (eg, time constraints and postmortem device disposal). Challenges to providing effective patient care included a lack of clinical suspicion of device failures, unfamiliarity with equipment, and an absence of digitally tailored clinical protocols. Participants agreed that cyberattacks should be classified as major incidents, with the repurposing of existing crisis resources. Treatment of patients was determined by the role technology played in clinical management, such that those reliant on potentially compromised laboratory or radiological facilities were prioritized. CONCLUSIONS: Here, we have framed digital events through a clinical lens, described in terms of their end-point impact on the patient. In doing so, we have developed a series of recommendations for ensuring responses to digital events are tailored to clinical needs and center patient care.

A Perspective on Crowdsourcing and Human-in-the-Loop Workflows in Precision Health.

Modern machine learning approaches have led to performant diagnostic models for a variety of health conditions. Several machine learning approaches, such as decision trees and deep neural networks, can, in principle, approximate any function. However, this power can be considered to be both a gift and a curse, as the propensity toward overfitting is magnified when the input data are heterogeneous and high dimensional and the output class is highly nonlinear. This issue can especially plague diagnostic systems that predict behavioral and psychiatric conditions that are diagnosed with subjective criteria. An emerging solution to this issue is crowdsourcing, where crowd workers are paid to annotate complex behavioral features in return for monetary compensation or a gamified experience. These labels can then be used to derive a diagnosis, either directly or by using the labels as inputs to a diagnostic machine learning model. This viewpoint describes existing work in this emerging field and discusses ongoing challenges and opportunities with crowd-powered diagnostic systems, a nascent field of study. With the correct considerations, the addition of crowdsourcing to human-in-the-loop machine learning workflows for the prediction of complex and nuanced health conditions can accelerate screening, diagnostics, and ultimately access to care.

[Development of competencies in the Medical Informatics Initiative (MII)-educational offers for a competent and secure handling of medical data]. / Kompetenzentwicklung in der Medizininformatik-Initiative (MII) ­ Lehrangebote für einen souveränen und sicheren Umgang mit medizinischen Daten.

In order to achieve the goals of the Medical Informatics Initiative (MII), staff with skills in the field of medical informatics and data science are required. Each consortium has established training activities. Further, cross-consortium activities have emerged. This article describes the concepts, implemented programs, and experiences in the consortia. Fifty-one new professorships have been established and 10 new study programs have been created: 1 bachelor's degree and 6 consecutive and 3 part-time master's degree programs. Further, learning and training opportunities can be used by all MII partners. Certification and recognition opportunities have been created.The educational offers are aimed at target groups with a background in computer science, medicine, nursing, bioinformatics, biology, natural science, and data science. Additional qualifications for physicians in computer science and computer scientists in medicine seem to be particularly important. They can lead to higher quality in software development and better support for treatment processes by application systems.Digital learning methods were important in all consortia. They offer flexibility for cross-location and interprofessional training. This enables learning at an individual pace and an exchange between professional groups.The success of the MII depends largely on society's acceptance of the multiple use of medical data in both healthcare and research. The information required for this is provided by the MII's public relations work. There is also an enormous need in society for medical and digital literacy.

The use of wearables for the diagnosis and treatment of Parkinson's disease.

Parkinson's disease (PD) is the second most common neurodegenerative disorder, with increasing numbers of affected patients. Many patients lack adequate care due to insufficient specialist neurologists/geriatricians, and older patients experience difficulties traveling far distances to reach their treating physicians. A new option for these obstacles would be telemedicine and wearables. During the last decade, the development of wearable sensors has allowed for the continuous monitoring of bradykinesia and dyskinesia. Meanwhile, other systems can also detect tremors, freezing of gait, and gait problems. The most recently developed systems cover both sides of the body and include smartphone apps where the patients have to register their medication intake and well-being. In turn, the physicians receive advice on changing the patient's medication and recommendations for additional supportive therapies such as physiotherapy. The use of smartphone apps may also be adapted to detect PD symptoms such as bradykinesia, tremor, voice abnormalities, or changes in facial expression. Such tools can be used for the general population to detect PD early or for known PD patients to detect deterioration. It is noteworthy that most PD patients can use these digital tools. In modern times, wearable sensors and telemedicine open a new window of opportunity for patients with PD that are easy to use and accessible to most of the population.

Consumer sleep technology for the screening of obstructive sleep apnea and snoring: current status and a protocol for a systematic review and meta-analysis of diagnostic test accuracy.

There are concerns about the validation and accuracy of currently available consumer sleep technology for sleep-disordered breathing. The present report provides a background review of existing consumer sleep technologies and discloses the methods and procedures for a systematic review and meta-analysis of diagnostic test accuracy of these devices and apps for the detection of obstructive sleep apnea and snoring in comparison with polysomnography. The search will be performed in four databases (PubMed, Scopus, Web of Science, and the Cochrane Library). Studies will be selected in two steps, first by an analysis of abstracts followed by full-text analysis, and two independent reviewers will perform both phases. Primary outcomes include apnea-hypopnea index, respiratory disturbance index, respiratory event index, oxygen desaturation index, and snoring duration for both index and reference tests, as well as the number of true positives, false positives, true negatives, and false negatives for each threshold, as well as for epoch-by-epoch and event-by-event results, which will be considered for the calculation of surrogate measures (including sensitivity, specificity, and accuracy). Diagnostic test accuracy meta-analyses will be performed using the Chu and Cole bivariate binomial model. Mean difference meta-analysis will be performed for continuous outcomes using the DerSimonian and Laird random-effects model. Analyses will be performed independently for each outcome. Subgroup and sensitivity analyses will evaluate the effects of the types (wearables, nearables, bed sensors, smartphone applications), technologies (e.g., oximeter, microphone, arterial tonometry, accelerometer), the role of manufacturers, and the representativeness of the samples.

Remote decentralized clinical trials: a new opportunity for laboratory medicine.

The traditional venue of clinical trials has been hospitals or specialized research units, usually requiring participants to come on-site. Although their contribution to biomedical progress is beyond dispute, they are characterised by two crucial logistical and ultimately scientifical limitations: poor retention and poor generalizability of results, as patients often have problems in concluding the investigation on-site. Remote Decentralised Clinical Trials (RDCTs) take advantage of digital technologies to design trial activities closer to the home of participants, with the aims of minimizing travel to health facilities and the risk of infections, improving the quality of life of participants and caregivers, reducing work absenteeism, including broader cohorts of patients and possibly reducing costs. RDCTs represent a minority of current global research, but the Covid-19 pandemic brought them to the fore. The authors of this paper promote the spread of RDCTs, building on early recommendations from international institutions, and provide some examples of their use and potential benefits in laboratory medicine.

The platform development, adherence and efficacy to a digital Brief therapy for insomnia (dBTI) during the COVID-19 pandemic.

Brief therapy for insomnia (BTI) is a short-term cognitive behavioral therapy for insomnia. At present, there is no study combining BTI with digital technology. However, in the context of the outbreak of coronavirus disease 2019 (COVID-19), patients with acute insomnia may need an online treatment which can quickly improve insomnia symptoms. Our team built a digital BTI (dBTI) platform based on the WeChat mini program. This research provides a framework design and a course design of dBTI, and evaluates the system via recruiting participants suffering from acute insomnia in pandemic. What's more, it explores patients' adherence, the efficiency of the system and their relationship. As the result demonstrates, 68% of participants have completed more than half of the course with medium to high adherence. Gender, pre-sleep arousal scale (PSAS) somatic score and insomnia severity index (ISI) score have affected participants' adherence, and higher adherence has led to better improvement in the severity of insomnia and somatic pre-sleep arousal. It is proved that the platform we built is effective, which not only offers an entry point for the study of how to set up a dBTI platform, but also provides theoretical basis for its clinical application.

Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review.

BACKGROUND: Digital therapeutics are patient-facing digital health interventions that can significantly alter the health care landscape. Despite digital therapeutics being used to successfully treat a range of conditions, their uptake in health systems remains limited. Understanding the full spectrum of uptake factors is essential to identify ways in which policy makers and providers can facilitate the adoption of effective digital therapeutics within a health system, as well as the steps developers can take to assist in the deployment of products. OBJECTIVE: In this review, we aimed to map the most frequently discussed factors that determine the integration of digital therapeutics into health systems and practical use of digital therapeutics by patients and professionals. METHODS: A scoping review was conducted in MEDLINE, Web of Science, Cochrane Database of Systematic Reviews, and Google Scholar. Relevant data were extracted and synthesized using a thematic analysis. RESULTS: We identified 35,541 academic and 221 gray literature reports, with 244 (0.69%) included in the review, covering 35 countries. Overall, 85 factors that can impact the uptake of digital therapeutics were extracted and pooled into 5 categories: policy and system, patient characteristics, properties of digital therapeutics, characteristics of health professionals, and outcomes. The need for a regulatory framework for digital therapeutics was the most stated factor at the policy level. Demographic characteristics formed the most iterated patient-related factor, whereas digital literacy was considered the most important factor for health professionals. Among the properties of digital therapeutics, their interoperability across the broader health system was most emphasized. Finally, the ability to expand access to health care was the most frequently stated outcome measure. CONCLUSIONS: The map of factors developed in this review offers a multistakeholder approach to recognizing the uptake factors of digital therapeutics in the health care pathway and provides an analytical tool for policy makers to assess their health system's readiness for digital therapeutics.

Examining Diversity in Digital Therapeutics Clinical Trials: Descriptive Analysis.

BACKGROUND: Digital therapeutics (DTx) are an emerging class of software-based medical therapies helping to improve care access and delivery. As we leverage these digital health therapies broadly in clinical care, it is important to consider sociodemographic representation underlying clinical trials data to ensure broad application to all groups. OBJECTIVE: We review current sociodemographic representation in DTx clinical trials using data from the Digital Therapeutics Alliance Product Library database. METHODS: We conducted a descriptive analysis of DTx products. We analyzed 15 manuscripts associated with 13 DTx products. Sociodemographic information was retrieved and compared with the US population's demographic distribution. RESULTS: The median study size and age of participants were 252 and 43.3 years, respectively. Of the 15 studies applicable to this study, 10 (67%) reported that females made up 65% or greater of the study cohort. A total of 14 studies reported race data with Black or African American and Asian American individuals underrepresented in 9 and 11 studies, respectively. In 7 studies that reported ethnicity, Hispanics were underrepresented in all 7 studies. Furthermore, 8 studies reported education levels, with 5 studies reporting populations in which 70% or greater had at least some college education. Only 3 studies reported health insurance information, each reporting a study cohort in which 100% of members were privately insured. CONCLUSIONS: Our findings indicate opportunities for improved sociodemographic representation in DTx clinical trials, especially for underserved populations typically underrepresented in clinical trials. This review is a step in examining sociodemographic representation in DTx clinical trials to help inform the path forward for DTx development and testing.

Conversational Agent Interventions for Mental Health Problems: Systematic Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND: Mental health problems are a crucial global public health concern. Owing to their cost-effectiveness and accessibility, conversational agent interventions (CAIs) are promising in the field of mental health care. OBJECTIVE: This study aims to present a thorough summary of the traits of CAIs available for a range of mental health problems, find evidence of efficacy, and analyze the statistically significant moderators of efficacy via a meta-analysis of randomized controlled trial. METHODS: Web-based databases (Embase, MEDLINE, PsycINFO, CINAHL, Web of Science, and Cochrane) were systematically searched dated from the establishment of the database to October 30, 2021, and updated to May 1, 2022. Randomized controlled trials comparing CAIs with any other type of control condition in improving depressive symptoms, generalized anxiety symptoms, specific anxiety symptoms, quality of life or well-being, general distress, stress, mental disorder symptoms, psychosomatic disease symptoms, and positive and negative affect were considered eligible. This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Data were extracted by 2 independent reviewers, checked by a third reviewer, and pooled using both random effect models and fixed effects models. Hedges g was chosen as the effect size. RESULTS: Of the 6900 identified records, a total of 32 studies were included, involving 6089 participants. CAIs showed statistically significant short-term effects compared with control conditions in improving depressive symptoms (g=0.29, 95% CI 0.20-0.38), generalized anxiety symptoms (g=0.29, 95% CI 0.21-0.36), specific anxiety symptoms (g=0.47, 95% CI 0.07-0.86), quality of life or well-being (g=0.27, 95% CI 0.16-0.39), general distress (g=0.33, 95% CI 0.20-0.45), stress (g=0.24, 95% CI 0.08-0.41), mental disorder symptoms (g=0.36, 95% CI 0.17-0.54), psychosomatic disease symptoms (g=0.62, 95% CI 0.14-1.11), and negative affect (g=0.28, 95% CI 0.05-0.51). However, the long-term effects of CAIs for the most mental health outcomes were not statistically significant (g=-0.04 to 0.39). Personalization and empathic response were 2 critical facilitators of efficacy. The longer duration of interaction with conversational agents was associated with the larger pooled effect sizes. CONCLUSIONS: The findings show that CAIs are research-proven interventions that ought to be implemented more widely in mental health care. CAIs are effective and easily acceptable for those with mental health problems. The clinical application of this novel digital technology will conserve human health resources and optimize the allocation of mental health services. TRIAL REGISTRATION: PROSPERO CRD42022350130; https://tinyurl.com/mvhk6w9p.

[Management solutions using digital technologies in the Healthy Moscow pavilions].

The digital transformation of healthcare is an integral part of the priorities in modern healthcare. A striking example of the practical implementation of compliance with the basic principles of digital healthcare is the Healthy Moscow project, which has been implemented since 2021, which has become a real breakthrough in Russia in ensuring accessibility and convenience in providing medical care to the population. The aim of the project is the early prevention of chronic non-communicable diseases, the formation of a healthy lifestyle and the improvement of the well-being of Moscow residents, as well as the development of a conscious attitude to taking care of their health. Pavilions in the park areas of Moscow are an integral part of the modern medical infrastructure, providing convenient conditions for obtaining medical advice and information. The article provides information on the types of digital technologies and basic equipment that the pavilions (large and small) are equipped with as part of the Healthy Moscow project, it is shown that the introduction of digital healthcare technologies is one of the key tasks of the national strategy of Russia, which contributes significantly contribution to the successful implementation of the Healthy Moscow project.

Reimbursement practices for use of digital devices in atrial fibrillation and other arrhythmias: a European Heart Rhythm Association survey.

Since digital devices are increasingly used in cardiology for assessing cardiac rhythm and detecting arrhythmias, especially atrial fibrillation (AF), our aim was to evaluate the expectations and opinions of healthcare professionals in Europe on reimbursement policies for the use of digital devices (including wearables) in AF and other arrhythmias. An anonymous survey was proposed through announcements on the European Heart Rhythm Association website, social media channels, and mail newsletter. Two hundred and seventeen healthcare professionals participated in the survey: 32.7%, reported regular use of digital devices, 45.2% reported that they sometimes use these tools, 18.6% that they do not use but would like to. Only a minority (3.5%) reported a lack of trust in digital devices. The survey highlighted a general propensity to provide medical consultation for suspected AF or other arrhythmias detected by a consumer-initiated use of digital devices, even if time constraints and reimbursement availability emerged as important elements. More than 85% of respondents agreed that reimbursement should be applied for clinical use of digital devices, also in different settings such as post-stroke, post-cardioversion, post-ablation, and in patients with palpitations or syncope. Finally, 73.6% of respondents confirmed a lack of reimbursement fees in their country for physicians' consultations (tracings interpretation) related to digital devices. Digital devices, including wearables, are increasingly and widely used for assessing cardiac rhythm and detecting AF, but a definition of reimbursement policies for physicians' consultations is needed.

The value of adherence information during clinical pharmaceutical trials.

BACKGROUND/AIMS: The quality of the evidence used to evaluate a drug's safety and efficacy depends, in part, on how well participants adhere to the prescribed drug-taking regime. There are multiple approaches to measure adherence in clinical trials, varying in their cost and accuracy. We demonstrate a method for evaluating the cost-effectiveness of common adherence monitoring methods, considering the costs and data quality for drugs that differ in how forgiving they are of nonadherence. METHODS: We propose a simulation approach to estimate the value of evidence about adherence, considering both costs of collection and potential errors in interpreting clinical trial results. We demonstrate the approach with a simulated clinical trial of nitrendipine, a common calcium channel blocker. We consider two trial designs, one using pretrial adherence to "enrich" the trial sample and one without an enrichment strategy. We use scenarios combining high and low values of two key properties of a clinical trial: participant adherence and drug forgiveness. RESULTS: Under the conditions of these simulations, the most cost-effective adherence monitoring approach depends on both trial participant adherence and drug forgiveness. For example, the enrichment strategy is not cost-effective for the base scenario (high forgiveness and high adherence), but is for other scenarios. We also estimate the effects of evaluable patient analysis, a controversial procedure that excludes nonadherent participants from the analyses, after a trial is completed. CONCLUSIONS: Our proposed approach can guide drug regulators and developers in designing efficient clinical trials and assessing the impact of nonadherence on trial results. It can identify cost-effective adherence-monitoring methods, given available knowledge about the methods, drug, and patients' expected adherence.

Evolution of Web-Based Training Videos Provided by the German Respiratory League for the Correct Inhalation Technique.

BACKGROUND/OBJECTIVE: To assess whether and how the use of scientifically established Web-based training videos for teaching correct inhalation technique in patients with chronic airway diseases has become accepted among the wider population. METHODS: The viewing trends of 141 freely available YouTube videos (full playing time, 01:31-04:37 min:s) provided by the German Respiratory League, covering a broad range of internationally prescribed devices, were analyzed over a 10-year period. Specific emphasis was placed both on German and international videos. RESULTS: The total number of views was 3,350,678. Non-German videos (English, Russian, Turkish, Greek, Arabic, Farsi, and Slovakian) accounted for 23.2% of the views. The number of views steadily increased between 2011 and 2020 with a mean annual increase of 54.0% (range 24.5/119.9%) compared to the respective previous year. By 2020, the incidence of views per 100,000 German inhabitants was 725 for German videos only and 1,030 for all videos. In terms of the annual trend, there were two peak viewing periods, namely in spring and late fall, while the lowest amount of views occurred in summer. CONCLUSION: This study highlights the rising impact of Web-based training videos used for teaching the correct use of inhalation devices, with a steady increase in the number of annual views and a clear seasonal peaking of views in spring and late fall.

Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review.

BACKGROUND: Suboptimal adherence to data collection procedures or a study intervention is often the cause of a failed clinical trial. Data from connected sensors, including wearables, referred to here as biometric monitoring technologies (BioMeTs), are capable of capturing adherence to both digital therapeutics and digital data collection procedures, thereby providing the opportunity to identify the determinants of adherence and thereafter, methods to maximize adherence. OBJECTIVE: We aim to describe the methods and definitions by which adherence has been captured and reported using BioMeTs in recent years. Identifying key gaps allowed us to make recommendations regarding minimum reporting requirements and consistency of definitions for BioMeT-based adherence data. METHODS: We conducted a systematic review of studies published between 2014 and 2019, which deployed a BioMeT outside the clinical or laboratory setting for which a quantitative, nonsurrogate, sensor-based measurement of adherence was reported. After systematically screening the manuscripts for eligibility, we extracted details regarding study design, participants, the BioMeT or BioMeTs used, and the definition and units of adherence. The primary definitions of adherence were categorized as a continuous variable based on duration (highest resolution), a continuous variable based on the number of measurements completed, or a categorical variable (lowest resolution). RESULTS: Our PubMed search terms identified 940 manuscripts; 100 (10.6%) met our eligibility criteria and contained descriptions of 110 BioMeTs. During literature screening, we found that 30% (53/177) of the studies that used a BioMeT outside of the clinical or laboratory setting failed to report a sensor-based, nonsurrogate, quantitative measurement of adherence. We identified 37 unique definitions of adherence reported for the 110 BioMeTs and observed that uniformity of adherence definitions was associated with the resolution of the data reported. When adherence was reported as a continuous time-based variable, the same definition of adherence was adopted for 92% (46/50) of the tools. However, when adherence data were simplified to a categorical variable, we observed 25 unique definitions of adherence reported for 37 tools. CONCLUSIONS: We recommend that quantitative, nonsurrogate, sensor-based adherence data be reported for all BioMeTs when feasible; a clear description of the sensor or sensors used to capture adherence data, the algorithm or algorithms that convert sample-level measurements to a metric of adherence, and the analytic validation data demonstrating that BioMeT-generated adherence is an accurate and reliable measurement of actual use be provided when available; and primary adherence data be reported as a continuous variable followed by categorical definitions if needed, and that the categories adopted are supported by clinical validation data and/or consistent with previous reports.

Characteristics of Mobile Health Platforms for Depression and Anxiety: Content Analysis Through a Systematic Review of the Literature and Systematic Search of Two App Stores.

BACKGROUND: Mobile health (mHealth) platforms show promise in the management of mental health conditions such as anxiety and depression. This has resulted in an abundance of mHealth platforms available for research or commercial use. OBJECTIVE: The objective of this review is to characterize the current state of mHealth platforms designed for anxiety or depression that are available for research, commercial use, or both. METHODS: A systematic review was conducted using a two-pronged approach: searching relevant literature with prespecified search terms to identify platforms in published research and simultaneously searching 2 major app stores-Google Play Store and Apple App Store-to identify commercially available platforms. Key characteristics of the mHealth platforms were synthesized, such as platform name, targeted condition, targeted group, purpose, technology type, intervention type, commercial availability, and regulatory information. RESULTS: The literature and app store searches yielded 169 and 179 mHealth platforms, respectively. Most platforms developed for research purposes were designed for depression (116/169, 68.6%), whereas the app store search reported a higher number of platforms developed for anxiety (Android: 58/179, 32.4%; iOS: 27/179, 15.1%). The most common purpose of platforms in both searches was treatment (literature search: 122/169, 72.2%; app store search: 129/179, 72.1%). With regard to the types of intervention, cognitive behavioral therapy and referral to care or counseling emerged as the most popular options offered by the platforms identified in the literature and app store searches, respectively. Most platforms from both searches did not have a specific target age group. In addition, most platforms found in app stores lacked clinical and real-world evidence, and a small number of platforms found in the published research were available commercially. CONCLUSIONS: A considerable number of mHealth platforms designed for anxiety or depression are available for research, commercial use, or both. The characteristics of these mHealth platforms greatly vary. Future efforts should focus on assessing the quality-utility, safety, and effectiveness-of the existing platforms and providing developers, from both commercial and research sectors, a reporting guideline for their platform description and a regulatory framework to facilitate the development, validation, and deployment of effective mHealth platforms.