Nutzenbewertung digitaler Gesundheitsanwendungen – Herausforderungen und Möglichkeiten

Hemkens, Lars G.

doi:10.1007/s00103-021-03413-x

Cited by 9 publications

(8 citation statements)

References 44 publications

(84 reference statements)

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“…A comparison group could be a waiting group approach, a guideline-conform face-to-face treatment or a regular treatment approach, which represents the most promising approach as the other two approaches are ethically less justifiable or represent a clear difference to the DiHA [ 47 ]. It would be conceivable to evaluate continuously changing variants of the same DiHA that are constantly compared with each other in a randomised way [ 48 ]. However, also the results of the experimental arm could be biased because the authors did not provide information on concomitant treatment.…”

Section: Discussionmentioning

confidence: 99%

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Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results

Lantzsch

Eckhardt

Campione

et al. 2022

BMC Health Serv Res

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Objectives Evidence-based decision-making is the sine qua non for safe and effective patient care and the long-term functioning of health systems. Since 2020 Digital Health Applications (DiHA) in Germany have been undergoing a systematic pathway to be reimbursed by statutory health insurance (SHI) which is attracting attention in other European countries. We therefore investigate coverage decisions on DiHA and the underlying evidence on health care effects, which legally include both medical outcomes and patient-centred structural and procedural outcomes. Methods Based on publicly available data of the Institute for Medicines and Medical Devices searched between 08/2021 and 02/2022, all DiHA listed in the corresponding registry and thus reimbursable by the SHI were systematically investigated and presented descriptively on the basis of predefined criteria, such as clinical condition, and costs. The clinical trials on DiHA permanently included in the registry were reviewed with regard to their study design, endpoints investigated, the survey instruments used, and whether an intention-to-treat analysis was performed. Risk of bias was assessed using the ROB II tool. Results By February 2022, 30 DiHA had been included in the DiHA registry, one third of them permanently and two thirds conditionally. Most DiHA were therapeutic applications for mental illness based on cognitive behavioural therapy. For all permanently included DiHA, randomised controlled trials were conducted to demonstrate the impact on health care effects. While medical outcomes were investigated for all of these DiHA, patient-centred structural and procedural outcomes were rarely investigated. The majority of clinical trials showed a high risk of bias, mainly due to insufficient reporting quality. Overall, the prices for DiHA covered by SHI are on average around € 150 per month (min. € 40; max. € 248). Conclusions Evidence-based decision-making on coverage of DiHA leaves room for improvements both in terms of reporting-quality and the use of patient-centred structural and procedural outcomes in addition to medical outcomes. With appropriate evidence, DiHA can offer an opportunity as an adjunct to existing therapy while currently the high risk of bias of the trials raises doubts about the justification of its high costs.

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Section: Discussionmentioning

confidence: 99%

“…There is a need for appropriate study characteristics to support the generation of evidence [ 19 ]. Advantages in pragmatic randomized trials can be seen because this study design is feasible and suitable for the characteristics of DiHA [ 48 , 53 ].…”

Section: Discussionmentioning

confidence: 99%

Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results

Lantzsch

Eckhardt

Campione

et al. 2022

BMC Health Serv Res

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“…The DiGA and its individual components are usually continuously adapted and further developed by the manufacturers, so that new versions are often already available before the evaluation of the original version is completed. One success factor here can be a continuous, learning evaluation of the continuously changing DiGA process [ 14 ]. Stern et al (2022) cite actual or perceived risks of regulatory uncertainty, as possible reasons for deciding against non-RCT studies.…”

Section: Methodsmentioning

confidence: 99%

“…Geier et al (2021) described different perspectives of the German Digital Health Association on DiGA, arguing the need for accompanying research to address the specific challenges of study design and methods in generating evidence for DiGA [ 13 ]. Hemkens et al (2021) also emphasized the relevance of a robust evidence-based benefit assessment in DiGA approvals, stating that sustainable and efficient DiGA benefit assessment requires continuously adjusted evaluation in everyday care; central to this are randomized study designs that are integrated into standard care [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis

Mäder

Timpel²,

Schönfelder³

et al. 2023

BMC Health Serv Res

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Background With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. Objective The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. Methods A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. Results All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. Discussion It is striking that— although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes — all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. Conclusion The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.

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“…Furthermore, with no valid causal models capturing complex interrelationship between interventions and regional settings, environments, population, cultural, social and economic factors nor high-quality, high-granular data reflecting these factors and allowing for statistical adjustments, there is a substantial risk of confounding bias, even for comparisons with parallel controls 12–14. Only a randomised trial may provide high quality evidence on comparative effects of interventions without the need to understand complex mechanisms and measure complex data 14–16…”

Section: Introductionmentioning

confidence: 99%

Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review

Hirt

Janiaud

Hemkens

2022

BMJ EBM

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ObjectiveWe aimed at providing a systematic overview of randomised trials assessing non-pharmaceutical interventions (NPIs) to prevent COVID-19.DesignScoping review.MethodsWe included all randomised trials assessing NPIs to prevent COVID-19 in any country and setting registered in ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform using the COVID-evidence platform (until 17 August 2021). We searched for corresponding publications in MEDLINE/PubMed, Google Scholar, the Living Overview of Evidence platform, and the Cochrane COVID-19 registry as well as for results posted in registries (until 14 November 2021). Descriptive statistics using numbers and percentages were used in the narrative synthesis of the results.ResultsWe identified 41 randomised trials. Of them, 12 were completed (29.3%) including 9 with published results. The 41 trials planned to recruit a median of 1700 participants (IQR 588–9500, range 30–35 256 399) with a median planned duration of 8 months (IQR 3–14, range 1–24). Most came from the USA (n=11, 26.8%). The trials mostly assessed protective equipment (n=11, 26.8%), COVID-19-related information and education programmes (n=9, 22.0%), access to mass events under specific safety measures (n=5, 12.2%), testing and screening strategies (n=5, 12.2%) and hygiene management (n=5, 12.2%).ConclusionsWorldwide, 41 randomised trials assessing NPIs have been initiated with published results available to inform policy decisions for only 9 of them. A long-term research agenda including behavioural, environmental, social and systems level interventions is urgently needed to guide policies and practices in the current and future public health emergencies.

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Nutzenbewertung digitaler Gesundheitsanwendungen – Herausforderungen und Möglichkeiten

Cited by 9 publications

References 44 publications

Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results

Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis

Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review

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