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Article ; Online: Tracing Digital Therapeutics Research Across Medical Specialties: Evidence from ClinicalTrails.gov.

Masanneck, Lars / Stern, Ariel D

2024

Abstract: Digital therapeutics (DTx), evidence-based software interventions for preventing, managing, or treating medical disorders, have rapidly evolved with healthcare's shift toward online, patient-centric solutions. This study scrutinizes DTx clinical trials ... ...

Abstract	Digital therapeutics (DTx), evidence-based software interventions for preventing, managing, or treating medical disorders, have rapidly evolved with healthcare's shift toward online, patient-centric solutions. This study scrutinizes DTx clinical trials from 2005 to 2022, analyzing their growth, funding, underlying medical specialties, and other R&D characteristics, using ClinicalTrials.gov data. Our analysis includes trials categorized via the ICD-11 system, covering active, recruiting, or completed studies and considering trials listing multiple conditions. In analyzing 5,889 registered DTx trials, we document a more than five-fold increase in such trials since 2011, and a compound annual growth rate of 22.82% since 2005. While most trials were single-center, the median number of study subjects increased in recent years, driven by larger interventional trials. The key disciplines driving this growth were psychiatry, neurology, oncology, and endocrinology. Mental health dominated DTx trials in recent years, led by neurocognitive disorders, substance abuse disorders, and mood disorders. Industry funding varied across disciplines and was particularly high in visual system diseases and dermatology. DTx trials have surged since 2005, accelerated by recent growth in mental health trials. These trends mirror developments toward remote healthcare delivery, amplified by digital health investments during the COVID-19 pandemic. Growing numbers of participants in DTx trials point to increased demand for more robust trials. However, because most trials are single-center and country-specific, more international cooperation and harmonized evaluation standards will be essential for DTx trials to become more efficient and provide validation across countries, health systems, and groups of individuals.
Language	English
Publishing date	2024-04-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.3260
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Digitale Medizin in der neurologischen Forschung – zwischen Hype und Evidenz.

Masanneck, Lars / Pawlitzki, Marc G / Meuth, Sven G

Der Nervenarzt

2023 Volume 95, Issue 3, Page(s) 230–235

Abstract: Background: The rapid advancement of digital medicine and health technologies in neurology offers both significant potential and challenges. This article outlines fundamental aspects of digital medicine related to neurological research and highlights ... ...

Title translation	Digital medicine in neurological research-Between hype and evidence.
Abstract	Background: The rapid advancement of digital medicine and health technologies in neurology offers both significant potential and challenges. This article outlines fundamental aspects of digital medicine related to neurological research and highlights application examples of digital technologies in neurological research. Aim: To provide a comprehensive overview of current digital developments in neurology and their impact on neurological research. Material and methods: In this narrative review articles from various sources and references related to digital medicine and health technologies in neurology were compiled and analyzed. Results and discussion: The data presented indicate that digital health technologies and digital therapeutics have the potential to decisively shape neurological care and research; however, it is emphasized that a critical evaluation and evidence-based approach to these technologies are essential to determine their actual value in neurology.
MeSH term(s)	Humans ; Telemedicine
Language	German
Publishing date	2023-12-14
Publishing country	Germany
Document type	English Abstract ; Journal Article ; Review
ZDB-ID	123291-5
ISSN	1433-0407 ; 0028-2804
ISSN (online)	1433-0407
ISSN	0028-2804
DOI	10.1007/s00115-023-01581-6
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Article: The PNS Nurse Program: A Health Care Support Concept for Patients With Immune-Mediated Peripheral Nervous System Diseases.

Pawlitzki, Marc / Gasis, Marcia / Masanneck, Lars / Meuth, Sven G / Ruck, Tobias

Neurology. Clinical practice

2024 Volume 14, Issue 3, Page(s) e200295

Abstract: Background: Immune-mediated peripheral nervous system (PNS) disorders pose diagnostic and therapeutic challenges, necessitating collaborative, patient-centered care. Limited access to specialized centers leads to delayed diagnosis and care, as seen ... ...

Abstract	Background: Immune-mediated peripheral nervous system (PNS) disorders pose diagnostic and therapeutic challenges, necessitating collaborative, patient-centered care. Limited access to specialized centers leads to delayed diagnosis and care, as seen during the COVID-19 pandemic. To address these challenges, accessible specialized care is crucial. On-site support plays a vital role in advising and assisting patients and caregivers, enabling multidisciplinary care for PNS diseases. Recent findings: The PNS Nurse Education Program tackles these complexities, using specialized nurses experienced in multiple sclerosis and Parkinson disease. Focusing on peripheral neuroimmunologic disorders, PNS nurses monitor disease severity, optimize communication, and provide therapeutic support in the recently started era of available immunotherapies. Collaboration with other healthcare sectors and support groups further enhances patient care. Implications for practice: Ultimately, the PNS Nurse Education Program aims to bridge the gap between complex treatments and limited specialized care, improving patient outcomes and relieving burdens on patients, caregivers, and healthcare systems.
Language	English
Publishing date	2024-04-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	2645818-4
ISSN	2163-0933 ; 2163-0402
ISSN (online)	2163-0933
ISSN	2163-0402
DOI	10.1212/CPJ.0000000000200295
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Article ; Online: Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials.

Masanneck, Lars / Gieseler, Pauline / Gordon, William J / Meuth, Sven G / Stern, Ariel D

NPJ digital medicine

2023 Volume 6, Issue 1, Page(s) 23

Abstract: Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered ... ...

Abstract	Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on ClinicalTrials.gov for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer's, and Parkinson's disease. We document growth in the collection of both more established digital measures (e.g., motor function) and more novel digital measures (e.g., speech) over recent years, highlighting contexts of use and key trends.
Language	English
Publishing date	2023-02-10
Publishing country	England
Document type	Journal Article
ISSN	2398-6352
ISSN (online)	2398-6352
DOI	10.1038/s41746-023-00767-1
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: A Study of the Geographic Accessibility of Outpatient Memory Clinics in Germany.

Masanneck, Lars / Butryn, Michaela / Nelke, Christopher / Repple, Jonathan / Meier, Uwe / Düzel, Emrah / Meuth, Sven G / Pawlitzki, Marc

Deutsches Arzteblatt international

2023 Volume 120, Issue 35-36, Page(s) 597–598

Language	English
Publishing date	2023-09-15
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2406159-1
ISSN	1866-0452 ; 1866-0452
ISSN (online)	1866-0452
ISSN	1866-0452
DOI	10.3238/arztebl.m2023.0149
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Article ; Online: Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials

Lars Masanneck / Pauline Gieseler / William J. Gordon / Sven G. Meuth / Ariel D. Stern

npj Digital Medicine, Vol 6, Iss 1, Pp 1-

2023 Volume 5

Abstract: Abstract Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials ... ...

Abstract	Abstract Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on ClinicalTrials.gov for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer’s, and Parkinson’s disease. We document growth in the collection of both more established digital measures (e.g., motor function) and more novel digital measures (e.g., speech) over recent years, highlighting contexts of use and key trends.
Keywords	Computer applications to medicine. Medical informatics ; R858-859.7
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Driving time-based identification of gaps in specialised care coverage: An example of neuroinflammatory diseases in Germany.

Masanneck, Lars / Räuber, Saskia / Schroeter, Christina B / Lehnerer, Sophie / Ziemssen, Tjalf / Ruck, Tobias / Meuth, Sven G / Pawlitzki, Marc

Digital health

2023 Volume 9, Page(s) 20552076231152989

Abstract: Objective: Due to the growing complexity in monitoring and treatment of many disorders, disease-specific care and research networks offer patients certified healthcare. However, the networks' ability to provide health services close to patients' homes ... ...

Abstract	Objective: Due to the growing complexity in monitoring and treatment of many disorders, disease-specific care and research networks offer patients certified healthcare. However, the networks' ability to provide health services close to patients' homes usually remains vague. Digital Health Technologies (DHTs) help to provide better care, especially if implemented in a targeted manner in regions undersupplied by specialised networks. Therefore, we used a car travel time-based isochrone approach to identify care gaps using the example of the neuroinflammation-focused German healthcare and research networks for multiple sclerosis (MS), myasthenia gravis (MG), myositis and immune-mediated neuropathy. Methods: Excellence centres were mapped, and isochrones for 30, 60, 90 and 120 minutes were calculated. The resulting geometric figures were aggregated and used to mask the global human settlement population grid 2019 to estimate German inhabitants that can reach centres within the given periods. Results: While 96.48% of Germans can drive to an MS-focused centre within one hour, coverage is lower for the rare disease networks for MG (48.3%), myositis (43.1%) and immune-mediated neuropathy (56.7%). Within 120 minutes, more than 80% of Germans can reach a centre of any network. Besides the generally worse covered rural regions such as North-Eastern Germany, the rare disease networks also show network-specific regional underrepresentation. Conclusion: An isochrone-based approach helps identify regions where specialised care is hard to reach, which might be especially troublesome in the case of an often disabled patient collective. Patient care could be improved by focusing deployments of disease-specific DHTs on these areas.
Language	English
Publishing date	2023-01-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	2819396-9
ISSN	2055-2076
ISSN	2055-2076
DOI	10.1177/20552076231152989
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Introducing electronic monitoring of disease activity in patients with chronic inflammatory demyelinating polyneuropathy (EMDA CIDP): trial protocol of a proof of concept study.

Masanneck, Lars / Voth, Jan / Huntemann, Niklas / Öztürk, Menekse / Schroeter, Christina B / Ruck, Tobias / Meuth, Sven G / Pawlitzki, Marc

Neurological research and practice

2023 Volume 5, Issue 1, Page(s) 39

Abstract: Introduction: Chronic inflammatory demyelinating polyneuropathy (CIDP) is one of the most common immune neuropathies leading to severe impairments in daily life. Current treatment options include intravenous immunoglobulins (IVIG), which are ... ...

Abstract	Introduction: Chronic inflammatory demyelinating polyneuropathy (CIDP) is one of the most common immune neuropathies leading to severe impairments in daily life. Current treatment options include intravenous immunoglobulins (IVIG), which are administered at intervals of 4-12 weeks. Determination of individual treatment intervals is challenging since existing clinical scores lack sensitivity to objectify small, partially fluctuating deficits in patients. End-of-dose phenomena described by patients, manifested by increased fatigue and worsening of (motor) symptoms, are currently difficult to detect. From a medical and socio-economic point of view, it is necessary to identify and validate new, more sensitive outcome measures for accurate mapping of disease progression and, thus, for interval finding. Digital health technologies such as wearables may be particularly useful for this purpose, as they record real-life data and consequently, in contrast to classic clinical 'snapshots', can continuously depict the disease course. Methods: In this prospective, observational, non-interventional, single-center, investigator-initiated study, CIDP patients treated with IVIG will be continuously monitored over a period of 6 months. Clinical scores and blood analyses will be assessed and collected during three visits (V1, V2, V3). Additionally, activity, sleep, and cardiac parameters will be recorded over the entire period using a wearable device. Further, patients' subjective disease development and quality of life will be recorded at various visits (read-outs). The usability of the smartwatch will be assessed at the end of the study. Perspective: The study aims to evaluate different digital measurements obtained with the smartwatch and blood-based analyses for monitoring disease activity and progress in CIDP patients. In conjunction, both means of monitoring might offer detailed insights into behavioral and biological patterns associated with treatment-related fluctuations such as end-of-dose phenomena. Trial registration: The study protocol was registered at ClinicalTrials.gov. Identifier: NCT05723848. Initially, the protocol was submitted prospectively on January 10, 2023. The trial was publicly released after formal improvements on February 13, 2023, after first patients were included according to the original protocol.
Language	English
Publishing date	2023-08-24
Publishing country	England
Document type	Journal Article
ISSN	2524-3489
ISSN (online)	2524-3489
DOI	10.1186/s42466-023-00267-3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Driving time-based identification of gaps in specialised care coverage

Lars Masanneck / Saskia Räuber / Christina B Schroeter / Sophie Lehnerer / Tjalf Ziemssen / Tobias Ruck / Sven G. Meuth / Marc Pawlitzki

Digital Health, Vol

An example of neuroinflammatory diseases in Germany

2023 Volume 9

Abstract: Objective Due to the growing complexity in monitoring and treatment of many disorders, disease-specific care and research networks offer patients certified healthcare. However, the networks’ ability to provide health services close to patients’ homes ... ...

Abstract	Objective Due to the growing complexity in monitoring and treatment of many disorders, disease-specific care and research networks offer patients certified healthcare. However, the networks’ ability to provide health services close to patients’ homes usually remains vague. Digital Health Technologies (DHTs) help to provide better care, especially if implemented in a targeted manner in regions undersupplied by specialised networks. Therefore, we used a car travel time-based isochrone approach to identify care gaps using the example of the neuroinflammation-focused German healthcare and research networks for multiple sclerosis (MS), myasthenia gravis (MG), myositis and immune-mediated neuropathy. Methods Excellence centres were mapped, and isochrones for 30, 60, 90 and 120 minutes were calculated. The resulting geometric figures were aggregated and used to mask the global human settlement population grid 2019 to estimate German inhabitants that can reach centres within the given periods. Results While 96.48% of Germans can drive to an MS-focused centre within one hour, coverage is lower for the rare disease networks for MG (48.3%), myositis (43.1%) and immune-mediated neuropathy (56.7%). Within 120 minutes, more than 80% of Germans can reach a centre of any network. Besides the generally worse covered rural regions such as North-Eastern Germany, the rare disease networks also show network-specific regional underrepresentation. Conclusion An isochrone-based approach helps identify regions where specialised care is hard to reach, which might be especially troublesome in the case of an often disabled patient collective. Patient care could be improved by focusing deployments of disease-specific DHTs on these areas.
Keywords	Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	006
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	SAGE Publishing
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Detecting ongoing disease activity in mildly affected multiple sclerosis patients under first-line therapies.

Masanneck, Lars / Rolfes, Leoni / Regner-Nelke, Liesa / Willison, Alice / Räuber, Saskia / Steffen, Falk / Bittner, Stefan / Zipp, Frauke / Albrecht, Philipp / Ruck, Tobias / Hartung, Hans-Peter / Meuth, Sven G / Pawlitzki, Marc

Multiple sclerosis and related disorders

2022 Volume 63, Page(s) 103927

Abstract: Background: The current range of disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis (RRMS) has placed more importance on the accurate monitoring of disease progression for timely and appropriate treatment decisions. With a ... ...

Abstract	Background: The current range of disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis (RRMS) has placed more importance on the accurate monitoring of disease progression for timely and appropriate treatment decisions. With a rising number of measurements for disease progression, it is currently unclear how well these measurements or combinations of them can monitor more mildly affected RRMS patients. Objectives: To investigate several composite measures for monitoring disease activity and their potential relation to the biomarker neurofilament light chain (NfL) in a clearly defined early RRMS patient cohort with a milder disease course. Methods: From a total of 301 RRMS patients, a subset of 46 patients being treated with a continuous first-line therapy was analyzed for loss of no evidence of disease activity (lo-NEDA-3) status, relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA), up to seven years after treatment initialization. Kaplan-Meier estimates were used for time-to-event analysis. Additionally, a Cox regression model was used to analyze the effect of NfL levels on outcome measures in this cohort. Results: In this mildly affected cohort, both lo-NEDA-3 and PIRA frequently occurred over a median observational period of 67.2 months and were observed in 39 (84.8%) and 23 (50.0%) patients, respectively. Additionally, 12 out of 26 PIRA manifestations (46.2%) were observed without a corresponding lo-NEDA-3 status. Jointly, either PIRA or lo-NEDA-3 showed disease activity in all patients followed-up for at least the median duration (67.2 months). NfL values demonstrated an association with the occurrence of relapses and RAW. Conclusion: The complementary use of different disease progression measures helps mirror ongoing disease activity in mildly affected early RRMS patients being treated with continuous first-line therapy.
MeSH term(s)	Cohort Studies ; Disease Progression ; Humans ; Multiple Sclerosis ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Recurrence
Language	English
Publishing date	2022-05-28
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2645330-7
ISSN	2211-0356 ; 2211-0348
ISSN (online)	2211-0356
ISSN	2211-0348
DOI	10.1016/j.msard.2022.103927
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