Digital health technologies have been enhancing the capacity of healthcare providers and, thereby, the delivery of targeted health services. The Southeast Asia Region (SEAR) has invested in strengthening digital public health. Many digital health interventions have been implemented in public health settings but are rarely assessed using the holistic health technology assessment (HTA) approach.

A systematic literature review was performed to provide an overview of evaluations of digital public health interventions in the World Health Organization (WHO) SEAR. Searches were conducted on four electronic databases. Screening title abstracts and full texts was independently conducted by two reviewers, followed by data extraction. Dimensions of HTA were analyzed against the EUnetHTA Core Model 3.0. Quality assessment of included articles was conducted using the JBI Checklist for Economic Evaluation and Consolidated Health Economic Evaluation Reporting Standards 2022 checklist to assess the reporting quality. The findings are presented using systematic evidence tables and bar charts.

Of the forty-three studies screened at the full-text stage, thirteen studies conducted across six countries were included in the analysis. Telemedicine and m-health interventions were assessed in ten studies. Nine studies conducted cost-effectiveness analysis, and five assessments were conducted from a societal perspective. Four studies utilized more than one perspective for the assessment. Health problem definition and current use of technology, description and technical characteristics of the technology, clinical effectiveness, costs, economic evaluation, and organizational aspects were assessed by all the studies, whereas legal aspects were least assessed.

The lack of HTAs on digital public health interventions in the region highlights the need for capacity-building efforts.

Dialectical behavior therapy (DBT) is a specialized treatment that has a growing evidence base for binge-spectrum eating disorders. However, cost and workforce capacity limit wide-scale uptake of DBT since it involves over 20 in-person sessions with a trained professional (and six sessions for guided self-help format). Interventions translated for delivery through modern technology offer a solution to increase the accessibility of evidence-based treatments. We developed the first DBT-specific skills training smartphone application (Resilience: eDBT) for binge-spectrum eating disorders and evaluated its efficacy in a randomized clinical trial.

Participants reporting recurrent binge eating were randomized to Resilience (n = 287) or a waitlist (n = 289). Primary outcomes were objective binge eating episodes and global levels of eating disorder psychopathology. Secondary outcomes were behavioral and cognitive symptoms, psychological distress, and the hypothesized processes of change (mindfulness, emotion regulation, and distress tolerance).

Intention-to-treat analyses showed that the intervention group reported greater reductions in objective binge eating episodes (incidence rate ratio = 0.69) and eating disorder psychopathology (d = −0.68) than the waitlist at 6 weeks. Significant group differences favoring the intervention group were also observed on secondary outcomes, except for subjective binge eating, psychological distress, and distress tolerance. Primary symptoms showed further improvements from 6 to 12 weeks. However, dropout rate was high (48%) among the intervention group, and engagement decreased over the study period.

A novel, low-intensity DBT skills training app can effectively reduce symptoms of eating disorders. Scalable apps like these may increase the accessibility of evidence-based treatments.

The aim of this study is to understand the path for establishing digital health technologies-health technology assessment (DHT-HTA) in India.

A rapid review of HTA and DHT frameworks on PubMed (MEDLINE) and Google Scholar was conducted to identify DHT-HTA guidelines, and HTA processes in India. MS-Excel template was created with key domains for assessing DHT in resource-constrained settings based on studies and reports identified. Responses received from seventeen experts with varying expertise in DHT, HTA, clinical, and research were contacted using an online form. Following the principles of qualitative research rooted on grounded theory approach, themes and domains were derived for a framework which was again circulated through participants. Weightage for each theme was assigned based on the frequency of responses and qualifiers were used to interpret results. Inductively derived themes from these responses were clubbed together to identify macro-level systems requirements, and finally pre-requisites for setting up DHT-HTA framework was synthesized.

HT are commonly perceived by experts (64.7 percent participants) as a technology strictly connected to health information. Real-world data (i.e., electronic health data) are recognized as a relevant tool in support of decision-making for clinical and managerial levels. Experts identified some pre-requisites for the establishment of DHT-HTA in the country in terms of infrastructure, contextual factors, training, finance, data security, and scale-up.

Our research not only identified the pre-requisites for the adoption of a DHT-HTA framework for India, but confirmed the need to address DHT-HTA’s acceptability among. Hospitals and health insurance providers.

In recent years, the importance of telemedicine has increased significantly. Especially in the field of echocardiography, virtual reality glasses offer the possibility of real-time data transmission without restrictions in the examination process. In particular, the care of critically ill newborns with suspected CHD might be improved by allowing a specialized paediatric cardiologist to remotely guide an echocardiographic examination. The current study aims to prove whether novices, under Google Glass guidance by a paediatric cardiologist, can perform an appropriate neonatal echocardiography.

The current study is a prospective monocentric single-blinded pilot study. Participants were supposed to perform two test runs: The first test run was “unguided” and the second test run was instructed via Google Glass. A validated training simulator for neonatal echocardiography “EchocomNeo, Echocom GmbH” was used. The study took place at the Leipzig Heart Center, Department of Pediatric Cardiology from April 2022 to November 2022.

A total of 21 medical students were enrolled. In total 252 views (126 views in each test run) were recorded. The overall performance was significantly higher in the Google Glass guided test run compared to “unguided” (structure score: 77.6% vs. 63.2%. p < 0.001 and quality score: 58.7% vs. 47.2%, p < 0.001). Also, the time was significantly lower in the Google Glass guided test run than in the unguided test run, p = 0.014.

Google Glass guidance by a paediatric cardiologist could optimize the performance of novices in echocardiography using a standardized neonatal echo-simulator with structural normal cardiac anatomy.

School refusal is a heterogenous problem which typically emerges in adolescence and co-occurs with internalising disorders. A substantial proportion of adolescents do not respond to existing treatment modalities; thus, novel, effective intervention options are needed. Partners in Parenting Plus (PiP+) is a coach-assisted, web-based intervention designed to empower parents to respond to adolescent internalising disorders.

To conduct a process evaluation of PiP+ and identify programme adaptations required to meet the needs of parents of adolescents who refuse school.

Semi-structured interviews were conducted with 14 Australian mothers who had: (a) received the PiP+ programme (not tailored for school refusal) during a prior research trial; and (b) reported that their adolescent was refusing school during their participation in PiP+. Inductive thematic analysis was used to analyse interview transcripts.

Participants were 41–53 years old (M = 47.8) and parenting adolescent children aged 14–17 years (M = 14.9). Three themes illustrated how PiP+ features met or could better meet the needs of parents of adolescents who were refusing school: (a) feeling heard, supported and respected; (b) relevance to me and my context; and (c) seeing positive changes. Participants had favourable views of PiP+, especially coached components. Participants requested programme enhancements to better meet the needs of parents of neurodiverse adolescents and discussed the impact of cumulative help-seeking ‘failures’ on self-efficacy and locus of control.

PiP+ was highly acceptable to the majority of parents navigating the issue of school refusal. This has implications for the enhancement of coach-assisted parenting interventions and the context-specific adaptation of PiP+ for school refusal.

Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia.

Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches.

Our results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety.

Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.

Germany’s 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for “prescribable” health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany’s Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA.

We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis.

When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs.

Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

During the COVID-19 pandemic, research organizations accelerated adoption of technologies that enable remote participation. Now, there’s a pressing need to evaluate current decentralization practices and develop appropriate research, education, and operations infrastructure. The purpose of this study was to examine current adoption of decentralization technologies in a sample of clinical research studies conducted by academic research organizations (AROs).

The setting was three data coordinating centers in the U.S. These centers initiated coordination of 44 clinical research studies during or after 2020, with national recruitment and enrollment, and entailing coordination between one and one hundred sites. We determined the decentralization technologies used in these studies.

We obtained data for 44/44 (100%) trials coordinated by the three centers. Three technologies have been adopted across nearly all studies (98–100%): eIRB, eSource, and Clinical Trial Management Systems. Commonly used technologies included e-Signature (32/44, 73%), Online Payments Portals (26/44, 59%), ePROs (23/44, 53%), Interactive Response Technology (22/44, 50%), Telemedicine (19/44, 43%), and eConsent (18/44, 41%). Wearables (7/44,16%) and Online Recruitment Portals (5/44,11%) were less common. Rarely utilized technologies included Direct-to-Patient Portals (1/44, 2%) and Home Health Nurse Portals (1/44, 2%).

All studies incorporated some type of decentralization technology, with more extensive adoption than found in previous research. However, adoption may be strongly influenced by institution-specific IT and informatics infrastructure and support. There are inherent needs, responsibilities, and challenges when incorporating decentralization technology into a research study, and AROs must ensure that infrastructure and informatics staff are adequate.

Although psychoeducation is generally recommended for the treatment of adult attention-deficit hyperactivity disorder (ADHD), participation in clinical psychoeducation groups is impeded by waiting times and the constrained number of patients who can simultaneously attend a group. Digital psychoeducation attempts are promising, but the rapidly expanding number of apps lack evidence and are mostly limited to only a few implemented interactive elements.

To determine the potential of digital, self-guided psychoeducation for adult ADHD, a newly developed interactive chatbot was compared with a previously validated, conventional psychoeducation app.

Forty adults with ADHD were randomised, of whom 17 participants in each group completed self-guided psychoeducation based on either a chatbot or conventional psychoeducation app between October 2020 and July 2021. ADHD core symptoms were assessed before and after the 3-week interventions, using both the blinded observer-rated Integrated Diagnosis of ADHD in Adulthood interview and the self-rated ADHD Self-Assessment Scale (ADHS-SB).

Observer- and patient-rated ADHD symptoms were significantly reduced from pre- to post-intervention (observer-rated: mean difference −6.18, 95% CI −8.06 to −4.29; patient-rated: mean difference −2.82, 95% CI −4.98 to −0.67). However, there were no group × intervention interaction effects that would indicate a stronger therapeutic benefit of one of the interventions. Likewise, administered psychoeducational knowledge quizzes did not show differences between the groups. No adverse events were reported.

Self-guided psychoeducation based on a chatbot or a conventional app appears similarly effective and safe for improving ADHD core symptoms. Future research should compare additional control interventions and examine patient-related outcomes and usability preferences in detail.