ABSTRACT
BACKGROUND: The 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 METHODS: In 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. RESULTS: 97 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 (ß = -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). CONCLUSION: Adherence 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.
Subject(s)
Cell Phone , Multiple Sclerosis/psychology , Patient Reported Outcome Measures , Quality of Life , Adult , Cohort Studies , Female , Humans , Male , Middle AgedABSTRACT
BACKGROUND: Adherence to multiple sclerosis (MS) disease-modifying drugs (DMDs) is essential for realization of their optimal effectiveness and benefits. OBJECTIVE: To evaluate the usefulness and validity of a smartphone-based e-diary as a tool for adherence assessment as well as its effectiveness as a promoter of adherence to DMDs. METHODS: An MS tailored e-diary (MyMS&Me) reminded patients to take their DMDs on time. DMD intake was self-recorded in the e-diary by the participants. Three methods of adherence evaluation were compared: e-diary derived, retrospective self-reported, and the medication possession rate (MPR). The proportion of patients with poor adherence to DMDs (defined as MPR <80%) among e-diary users was compared with a control group without intervention. RESULTS: Sixty-two patients downloaded the e-diary (Female: 41 (66%), Expanded Disability Status Scale 3.2 ± 2.2) and 55 controls were enrolled. The median difference between e-diary-derived adherence and the MPR was -3% (95% limits of agreement: -53% to 12%). The median difference between retrospective self-reported adherence and the MPR was 0.3% (95% limits of agreement: -20% to 42%). The proportion of participants with poor adherence to DMDs was similar in the e-diary and control groups (10% vs. 13%, p = 0.6). CONCLUSIONS: Substantial and clinically important disagreement between methods of medication adherence evaluation was noted. Smartphone reminders did not significantly improve the MPR of DMDs.
