Observational studyPloS one2021
Mobile-phone-based e-diary derived patient reported outcomes: Association with clinical disease activity, psychological status and quality of life of patients with multiple sclerosis.
Observational study in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Use of mobile technology for reporting the pharmacovigilance of vaccines in Panama.Preventive medicine reports · 2025Article
- Measuring Disease Progression in Multiple Sclerosis Clinical Drug Trials and Impact on Future Patient Care.CNS drugs · 2025Review
- Remote Testing Apps for Multiple Sclerosis Patients: Scoping Review of Published Articles and Systematic Search and Review of Public Smartphone Apps.JMIR neurotechnology · 2023Review
- Electronic Health Diary Campaigns to Complement Longitudinal Assessments in Persons With Multiple Sclerosis: Nested Observational Study.JMIR mHealth and uHealth · 2022Observational
- MindKind: A mixed-methods protocol for the feasibility of global digital mental health studies in young people.Wellcome open research · 2021Article
- Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe applicability of mobile digital technology to promote clinical care of people with multiple sclerosis (pwMS) is gaining increased interest as part of the implementation of patient-centered approaches. We aimed at assessing adherence to a smartphone-based e-diary, which was designed to collect patient-reported outcomes (PROs). Secondary objectives were to evaluate the construct and predictive validity of e-diary derived PROs and to explore the various factors that were associated with changes in PROs over time. MATERIALS AND
methodsIn this observational cohort study patients downloaded an MS tailored e-diary into their personal smartphones. Report of PROs was enquired once monthly for a period of one year through a smartphone-based application, using previously validated tools. An e-diary derived bodily function summary score (eBF) was defined as the sum of scores depicting vision, limbs function, pain, bowl/ bladder dysfunction, pseudobulbar affect and spasticity. Multiple linear regression and analysis of covariance were used to determine the association between PROs, clinician-reported outcomes (ClinROs) of disease activity and quality of life (QoL). Regression coefficient analysis was used to compare the slope of change in eBF before and after a relapse.
results97 pwMS downloaded the e-diary [Female: 64 (66%), EDSS 3.4±2.1]. 76 patients (78%) completed the 12-month study period. 53 patients (55%) submitted ≥75% of requested surveys. Anxiety was negatively associated with adherence to periodic PROs assessments by the e-diary. E-diary derived PROs were significantly correlated with corresponding functional system scores (0.38< r <0.8, P<0.001). eBF score significantly predicted QoL (β = -0.36, P = 0.001) while EDSS did not. Change in eBF score over time was independently associated with the occurrence of an MS relapse (F = 4.4, P = 0.04), anxiety (F = 6.4, P = 0.01) and depression (F = 5.1, P = 0.03). Individual regression slopes of eBF scores were significantly higher pre-relapse than post-relapse (3.0±3.3 vs. -0.8±2.0, P = 0.007).
conclusionAdherence of pwMS to recording in an e-diary collecting PROs was high. Changes in e-diary derived PROs over time predict clinical MS relapses on the group level and thus carry the potential of usage in clinical research as well as for improved MS care in real world setting.
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