Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study.
Digital biomarkers
Mobile health
Multiple sclerosis
Smartphone
Smartwatch
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Jan 2023
Jan 2023
Historique:
received:
26
05
2022
accepted:
21
07
2022
revised:
21
07
2022
pubmed:
31
8
2022
medline:
7
1
2023
entrez:
30
8
2022
Statut:
ppublish
Résumé
There is an unmet need for reliable and sensitive measures for better monitoring people with multiple sclerosis (PwMS) to detect disease progression early and adapt therapeutic measures accordingly. To assess reliability of extracted features and meaningfulness of 11 tests applied through a smartphone application ("dreaMS"). PwMS (age 18-70 and EDSS ≤ 6.5) and matched healthy volunteers (HV) were asked to perform tests installed on their smartphone once or twice weekly for 5 weeks. Primary outcomes were test-retest reliability of test features (target: intraclass correlation [ICC] ≥ 0.6 or median coefficient of variation [mCV] < 0.2) and reported meaningfulness of the tests by PwMS. Meaningfulness was self-assessed for each test on a 5-point Likert scale (target: mean score of > 3) and by a structured interview. gov Identifier: NCT04413032. We included 31 PwMS (21 [68%] female, mean age 43.4 ± 12.0 years, median EDSS 3.0 [range 1.0-6.0]) and 31 age- and sex-matched healthy volunteers. Out of 133 features extracted from 11 tests, 89 met the preset reliability criteria. All 11 tests were perceived as highly meaningful to PwMS. The dreaMS app reliably assessed features reflecting key functional domains meaningful to PwMS. More studies with longer follow-up are needed to prove validity of these measures as digital biomarkers in PwMS.
Sections du résumé
BACKGROUND
BACKGROUND
There is an unmet need for reliable and sensitive measures for better monitoring people with multiple sclerosis (PwMS) to detect disease progression early and adapt therapeutic measures accordingly.
OBJECTIVE
OBJECTIVE
To assess reliability of extracted features and meaningfulness of 11 tests applied through a smartphone application ("dreaMS").
METHODS
METHODS
PwMS (age 18-70 and EDSS ≤ 6.5) and matched healthy volunteers (HV) were asked to perform tests installed on their smartphone once or twice weekly for 5 weeks. Primary outcomes were test-retest reliability of test features (target: intraclass correlation [ICC] ≥ 0.6 or median coefficient of variation [mCV] < 0.2) and reported meaningfulness of the tests by PwMS. Meaningfulness was self-assessed for each test on a 5-point Likert scale (target: mean score of > 3) and by a structured interview.
CLINICALTRIALS
RESULTS
gov Identifier: NCT04413032.
RESULTS
RESULTS
We included 31 PwMS (21 [68%] female, mean age 43.4 ± 12.0 years, median EDSS 3.0 [range 1.0-6.0]) and 31 age- and sex-matched healthy volunteers. Out of 133 features extracted from 11 tests, 89 met the preset reliability criteria. All 11 tests were perceived as highly meaningful to PwMS.
CONCLUSION
CONCLUSIONS
The dreaMS app reliably assessed features reflecting key functional domains meaningful to PwMS. More studies with longer follow-up are needed to prove validity of these measures as digital biomarkers in PwMS.
Identifiants
pubmed: 36042020
doi: 10.1007/s00415-022-11306-5
pii: 10.1007/s00415-022-11306-5
pmc: PMC9427170
doi:
Banques de données
ClinicalTrials.gov
['NCT04413032']
Types de publication
Clinical Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
262-271Informations de copyright
© 2022. The Author(s).
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