Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps

Tarricone, Rosanna; Petracca, Francesco; Cucciniello, Maria; Ciani, Oriana

doi:10.1002/hec.4505

Cited by 19 publications

(19 citation statements)

References 71 publications

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“…However, the evidence base for coverage decisions is a frequently and highly discussed topic. Increasingly, models are being developed to evaluate DiHA [16][17][18] also due to methodological gaps and difficulties in assessing the value of DiHA, including the question for an adequate control group to be included in clinical trials and the level of evidence to be used [19].…”

Section: Introductionmentioning

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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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: Introductionmentioning

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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“…More common and less urgent situations can be covered even with the vignette study. Finally, although the production of research data was slowed down by the COVID-19 pandemic [54,55], the number of individual users of mobile medical apps and Omaolo.fi grew exponentially during the pandemic [56][57][58].…”

Section: Strengths and Weaknessesmentioning

confidence: 99%

User-Initiated Symptom Assessment With an Electronic Symptom Checker: Protocol for a Mixed Methods Validation Study

Liu¹,

Kaila²,

Koskela³

2023

JMIR Res Protoc

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Background The national Omaolo digital social welfare and health care service of Finland provides a symptom checker, Omaolo, which is a medical device (based on Duodecim Clinical Decision Support EBMEDS software) with a CE marking (risk class IIa), manufactured by the government-owned DigiFinland Oy. Users of this service can perform their triage by using the questions in the symptom checker. By completing the symptom checker, the user receives a recommendation for action and a service assessment with appropriate guidance regarding their health problems on the basis of a selected specific symptom in the symptom checker. This allows users to be provided with appropriate health care services, regardless of time and place. Objective This study describes the protocol for the mixed methods validation process of the symptom checker available in Omaolo digital services. Methods This is a mixed methods study using quantitative and qualitative methods, which will be part of the clinical validation process that takes place in primary health care centers in Finland. Each organization provides a space where the study and the nurse triage can be done in order to include an unscreened target population of users. The primary health care units provide walk-in model services, where no prior phone call or contact is required. For the validation of the Omaolo symptom checker, case vignettes will be incorporated to supplement the triage accuracy of rare and acute cases that cannot be tested extensively in real-life settings. Vignettes are produced from a variety of clinical sources, and they test the symptom checker in different triage levels by using 1 standardized patient case example. Results This study plan underwent an ethics review by the regional permission, which was requested from each organization participating in the research, and an ethics committee statement was requested and granted from Pirkanmaa hospital district’s ethics committee, which is in accordance with the University of Tampere’s regulations. Of 964 clinical user–filled symptom checker assessments, 877 cases were fully completed with a triage result, and therefore, they met the requirements for clinical validation studies. The goal for sufficient data has been reached for most of the chief symptoms. Data collection was completed in September 2019, and the first feasibility and patient experience results were published by the end of 2020. Case vignettes have been identified and are to be completed before further testing the symptom checker. The analysis and reporting are estimated to be finalized in 2024. Conclusions The primary goals of this multimethod electronic symptom checker study are to assess safety and to provide crucial information regarding the accuracy and usability of the Omaolo electronic symptom checker. To our knowledge, this will be the first study to include real-life clinical cases along with case vignettes. International Registered Report Identifier (IRRID) DERR1-10.2196/41423

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“…In this supplement, Tarricone et al. analyzed current assessment frameworks for digital technologies and concluded that none is sufficiently complete as to encompass all relevant domains for regulatory, policymaking, HTA and coverage purposes (Tarricone et al., 2022). The authors identified 10 principles that would need to inspire assessment frameworks based on a life‐cycle evidence generation approach for mHealth apps.…”

Section: Research Aim 1: Improving the Evaluation Of Medical Devicesmentioning

confidence: 99%

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project

Torbica

Tarricone

Schreyögg³

et al. 2022

Health Economics

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Health technologies defined broadly embrace a range of applications of organized knowledge and skills in the form of pharmaceuticals, medical devices, vaccines, medical and surgical procedures, and systems developed to improve health. Within this broad definition, medical devices include a wide-ranging and heterogeneous group of health technologies that are used to diagnose illness, to monitor treatments, to treat acute and chronic illnesses, and to assist disabled people. The European Union (EU) market has over 500,000 types of medical devices. With an estimated market size of roughly €100 billion, medical devices account for about 7.5% of healthcare expenditure in most publicly funded healthcare systems. These technologies are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to policy makers. The challenge is to adopt policies to allow access to safe and effective technologies while providing adequate incentives to the industry to invest in research and development of new products.In the effort to properly address these challenges and overcome the gaps of the past, policy makers in Europe have for years discussed new rules for licensing and market access of medical devices in the EU market. These long discussions resulted in

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Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps

Cited by 19 publications

References 71 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

User-Initiated Symptom Assessment With an Electronic Symptom Checker: Protocol for a Mixed Methods Validation Study

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project

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