Abstract
BackgroundTreatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes. These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient-reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression, and sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS and their health-related quality of life. However, the assessment of PROs consumes resources, including time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed.ObjectiveWe aim to provide a rationale and pilot study protocol for a mobile health (mHealth) solution named “haMSter” that allows for remote monitoring of PROs in people with MS.MethodsThe core function of haMSter is to provide three scientifically validated PRO questionnaires relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit.ResultsThe pilot study is currently ongoing and will evaluate adherence to this mHealth solution in 50 patients over a period of 6 months. Results from the haMSter pilot study are expected in 2021.ConclusionshaMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and ultimately saves time.Trial RegistrationClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863International Registered Report Identifier (IRRID)DERR1-10.2196/25011
Highlights
Multiple Sclerosis and Patient-Reported OutcomesMultiple sclerosis (MS) is a chronic neurological disease associated with inflammation and neurodegeneration
We aim to provide a rationale and pilot study protocol for a mobile health solution named “haMSter” that allows for remote monitoring of patient-reported outcomes (PROs) in people with multiple sclerosis (MS)
Baseline and Sociodemographic Characteristics To provide an overview of the patients participating in this pilot study, we will report typical baseline and sociodemographic characteristics documented at baseline and follow-up
Summary
Multiple Sclerosis and Patient-Reported OutcomesMultiple sclerosis (MS) is a chronic neurological disease associated with inflammation and neurodegeneration. Disease monitoring in people with MS encompasses continuous evaluation of the following three major components: clinical disease activity, radiological disease activity, and, albeit mostly for research purposes, biomarkers [4,5] These outcomes can be summarized as clinician-reported outcomes. Treatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Conclusions: haMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and saves time. Trial Registration: ClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863 International Registered Report Identifier (IRRID): DERR1-10.2196/25011
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