Observational designs in clinical multiple sclerosis research: Particulars, practices and potentialities

Jongen, Peter Joseph

doi:10.1016/j.msard.2019.07.006

Cited by 2 publications

(2 citation statements)

References 95 publications

(133 reference statements)

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“…National registries from European countries, including Sweden, France and Italy have significantly improved our understanding of MS disease trajectories and the influence of treatment on these. 2 MSBase is a collaborative, international disease registry, which captures a range of MS-related data from a large number of countries. 3 More recently, processes for formal data sharing have started to enable the pooling of data from five large registries (Sweden, France, Italy, Denmark, MSBase).…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis

et al. 2021

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IntroductionThe power of ‘real world’ data to improve our understanding of the clinical aspects of multiple sclerosis (MS) is starting to be realised. Disease modifying therapy (DMT) use across the UK is driven by national prescribing guidelines. As such, the UK provides an ideal country in which to gather MS outcomes data. A rigorously conducted observational study with a focus on pharmacovigilance has the potential to provide important data to inform clinicians and patients while testing the reliability of estimates from pivotal trials when applied to patients in the UK.Methods and analysisThe primary aim of this study is to characterise the incidence and compare the risk of serious adverse events in people with MS treated with DMTs. The OPTIMISE:MS database enables electronic data capture and secure data transfer. Selected clinical data, clinical histories and patient-reported outcomes are collected in a harmonised fashion across sites at the time of routine clinical visits. The first patient was recruited to the study on 24 May 2019. As of January 2021, 1615 individuals have baseline data recorded; follow-up data are being captured and will be reported in due course.Ethics and disseminationThis study has ethical permission (London City and East; Ref 19/LO/0064). Potential concerns around data storage and sharing are mitigated by the separation of identifiable data from all other clinical data, and limiting access to any identifiable data. The results of this study will be disseminated via publication. Participants provide consent for anonymised data to be shared for further research use, further enhancing the value of the study.

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Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis

et al. 2021

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“…Moreover, the external validity of trial results is not self-evident, given that patient preferences may differ between regions or countries and preferences may change over time and the ongoing development of the tools. Therefore, prospective observational studies in real-world settings and retrospective studies using large databases are increasingly being considered as alternatives for obtaining actionable data [56,57].…”

Section: Comparison With Prior Workmentioning

confidence: 99%

The Interactive Web-Based Program MSmonitor for Self-Management and Multidisciplinary Care in Persons With Multiple Sclerosis: Quasi-Experimental Study of Short-Term Effects on Patient Empowerment

Jongen¹,

Veen²,

Lemmens³

et al. 2020

J Med Internet Res

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Background Empowerment helps persons with a chronic disease to self-manage their condition and increase their autonomy and participation. MSmonitor (Curavista bv) is an interactive Web-based program for self-management and multidisciplinary care in multiple sclerosis (MS). It includes, among others, short questionnaires on fatigue (Modified Fatigue Impact Scale-5 [MFIS-5]) and health-related quality of life (HRQoL, Leeds Multiple Sclerosis Quality of Life [LMSQoL]); long questionnaires on disabilities, perception of disabilities (Multiple Sclerosis Impact Profile), and HRQoL (Multiple Sclerosis Quality of Life-54); a Medication and Adherence Inventory and an Activity Diary. The combination MFIS-5, LMSQoL, and Medication and Adherence Inventory constitutes the Quick Scan. Objective This study aimed to investigate the short-term effects of MSmonitor on empowerment in patients with MS. Methods We conducted a quasi-experimental study in a general hospital. Of the 180 patients with MS, 125 were eligible, 30 used MSmonitor, and 21 participated in the study (mean age 45.4 years, SD 10.2 years). A total of 24 eligible patients who did not use MSmonitor constituted the control group (mean age 49.3 years, SD 11.4 years). At baseline and at 4 months, we assessed self-efficacy (Multiple Sclerosis Self-Efficacy Scale [MSSES]), participation and autonomy (Impact on Participation and Autonomy [IPA] questionnaire), and self-management (Partners In Health [PIH] questionnaire). Differences between time points and groups were tested with paired t tests and χ² tests. Results In the MSmonitor group, follow-up values remained unchanged for MSSES control (P=.19), MSSES function (P=.62), IPA limitations (P=.26), IPA problems (P=.40), PIH recognition and management of symptoms (P=.52), PIH adherence to treatment (P=.80), and PIH coping (P=.73), whereas the PIH knowledge score had improved (mean 27.8, SD 1.7 vs mean 28.7, SD 2.0; P=.02). The overall utilization rate of the program components was 83% and that of the Quick Scan was 95%. In the control group, all outcomes had remained unchanged. Conclusions The results suggest that for first-time users of the MSmonitor program and their health care providers, it may not be justified to expect a short-term improvement in empowerment in terms of self-efficacy, self-management, autonomy, or participation. Furthermore, a lack of effect on empowerment is not because of nonusage of the program components.

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Observational designs in clinical multiple sclerosis research: Particulars, practices and potentialities

Cited by 2 publications

References 95 publications

OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis

OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis

The Interactive Web-Based Program MSmonitor for Self-Management and Multidisciplinary Care in Persons With Multiple Sclerosis: Quasi-Experimental Study of Short-Term Effects on Patient Empowerment

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