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.
Highlights
The advent of mobile electronic platforms opened up the possibility for interactive diaries that remind patients to enter data, prospectively collect information about patients’ symptoms while at their natural environment and present a comprehensive reflection of disease status from the patients’ perspective as part of the implementation of patient centric approach and participatory medicine [1,2,3,4]
Multiple linear regression and analysis of covariance were used to determine the association between patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs) of disease activity and quality of life (QoL)
Anxiety was negatively associated with adherence to periodic PROs assessments by the e-diary
Summary
The advent of mobile electronic platforms opened up the possibility for interactive diaries that remind patients to enter data, prospectively collect information about patients’ symptoms while at their natural environment and present a comprehensive reflection of disease status from the patients’ perspective as part of the implementation of patient centric approach and participatory medicine [1,2,3,4]. PROs have many potential uses, such as promoting communication between patients and physicians, assessing change in disease status, screening for unidentified symptoms as well as monitoring safety and efficacy of medications [7, 8]. Traditional physician derived endpoints, like the neurological examination and the expanded disability status scale (EDSS), do not capture the gamut of MS symptoms, such as pain, fatigue, depression and sleep disturbance. These are better depicted by PROs, which despite being subjective, have been shown to correlate with objective assessments [9,10,11], predict objective disease worsening [12] and have an important association with quality of life (QoL) [13]. 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
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