Screening people with Multiple Sclerosis for cognitive problems does not make depression, anxiety and self-efficacy worse: Results from a multi-centre, longitudinal observational study

Abstract

Introduction: There have been calls for better screening and monitoring of cognitive problems in people with MS (pwMS), but some clinicians have raised concerns that cognitive screening could have a negative impact on people's mood. The NEuRoMS programme (www.neuroms.org) developed a free, online screening tool that pwMS can complete on their electronic devices at home before their routine clinical appointments. Objectives/Aims: This study aimed to examine the potential impact of the NEuRoMS screening on pwMS' mood and self-efficacy. Method(s): This was a multi-centre, longitudinal observational study design across seven sites with MS outpatient clinics, of which three implemented the routine cognitive screening prior to clinic attendance. We compared two groups: screened (s) vs nonscreened (ns) pwMS at three time points (baseline, 2-week and 4-week follow-ups). All participants completed the Patient Health Questionnaire-8 (PHQ-8), Generalised Anxiety Disorder-7 (GAD- 7), and Multiple Sclerosis Self-Efficacy Scale (MSSE) at baseline (before screening at three screened sites) and at 2-week and 4-week follow-ups. Linear mixed models were applied for each outcome measure to assess change over time. Covariates were age and duration of MS; factors were gender, education, MS type and ethnicity; site as a random effect; time, group and time*group interaction. Result(s): There were 452 (241 s, 211 ns) pwMS who completed the outcome measures at all time points. For the PHQ-8, the mean score at baseline was 8.4 (SD=6.0) and the scores did not change significantly over time in either group. For the GAD-7, the mean score at baseline was 6.0 (SD=5.4) and the scores did not change significantly over time in either group. For MSSE, the mean score at baseline was 49.0 (SD 13.6) and the scores did not change significantly over time in either group. Conclusion(s): Our results suggest that screening pwMS for cognitive problems using the NEuRoMS screening technology does not make depression, anxiety and self-efficacy worse. The analysis did not detect a difference of a magnitude that would be considered clinically significant across time or groups. The three screened sites have screened and triaged >3000 pwMS with no adverse events reported in relation to the NEuRoMS cognitive screening. Therefore, our online cognitive screening appears safe to be used within routine clinical practice. Introduction: Cognitive problems affect 40-60% of people with Multiple Sclerosis (pwMS), but are not routinely screened for in MS clinics in the UK due to limited resources (including personnel to deliver cognitive tests) and finances (including payment for such tests). Consequently, those with cognitive problems are not identified early and triaged to receive the appropriate level of support. To address this gap, the NEuRoMS programme (www.neuroms. org) developed a neuropsychological pathway to routinely assess all pwMS attending MS clinics for cognitive problems. The pathway has been implemented in three UK MS clinics and has screened >3000 pwMS. Objectives/Aims: This work presents the iterative design and development process of the Word Colour Task (WCT), a free, online self-administered measure of selective attention and information processing. This has been included in the NEuRoMS cognitive screening pathway to screen pwMS for cognitive problems. Method(s): We followed an iterative development process and conducted multiple rounds of user testing. Beginning with a prototype based on literature and previous research, we held three stakeholder meetings with Patient and Public Involvement members, researchers and clinicians working with pwMS (n=18) to make design decisions. Following stakeholder feedback, we developed product specifications for a technical team to develop the online WCT. We then tested usability and acceptability through cognitive interviews with eight pwMS and made revisions. A further round of user-testing was undertaken before deployment into the NEuRoMS screening pathway. Result(s): User testing and cognitive interviews suggested that the WCT was acceptable, but some usability issues were identified (e.g., clarity of instructions, practice mode, repetition of stimuli) and suggestions were made to improve user experiences. Conclusion(s): Using an iterative design approach with significant and diverse stakeholder input, we were able to develop a robust and usable online cognitive screening assessment tool. The WCT has now been deployed in three MS clinics for feasibility testing having screened 370 pwMS. Validation and norming studies are currently underway to provide further evidence of its psychometric properties and collect UK-based norms. Introduction: Due to the revised 2017 McDonald diagnostic criteria, many more people undergo lumbar punctures as part of their Multiple Sclerosis (MS) diagnostic journey. This results in discomfort and additional costs. Patients often report they find the lumbar puncture painful, and it can cause unintended complications requiring hospitalisations or time off work to recover. Brain lesions with a central vein, detected with T2* MRI are thought to be characteristic of MS. The Central Vein Sign (CVS) supports the diagnosis of MS when over 40% of eligible MRI lesions have a visible central vein. The authors will present the final results from DECISIve - DiagnosE using the Central veIn SIgn (Clinical Trials reference: NCT04024969) at ECTRIMS 2023. Objectives/Aims: To investigate whether T2* MRI is a more sensitive diagnostic test than lumbar puncture with oligoclonal band examination, in people at first clinical presentation with possible MS. Method(s): A multicentre prospective single group superiority diagnostic accuracy study. Participants presenting with typical clinically isolated syndrome requiring a lumbar puncture to meet the 2017 McDonald diagnostic criteria for MS were enrolled. Trial participants had an eight-minute T2* MRI scan sequence in addition to their lumbar puncture. The final clinical diagnosis is established after at least 18 months of follow up. Result(s): Of 113 participants recruited, we were able to include 49 in a preliminary analysis. The sensitivity of the CVS to confirm a diagnosis of MS is 94% and lumbar puncture with oligoclonal band examination is 84% (McNemar test; p=0.453). Conclusion(s): The DECISIve interim analysis has shown that the sensitivity of the CVS is higher than testing for oligoclonal bands by lumbar puncture for the diagnosis of multiple sclerosis. We expect that the full DECISIve dataset will have sufficient power to confirm whether there is a clinically meaningful difference or not. There is only a single discordant result between CVS with a threshold of 40% and the 'rule of six', suggesting this could be rapidly implemented in clinical practice. Further analysis will include comparing the accuracy, speed, costs, and acceptability of the different tests and aim to establish if most lumbar punctures can be replaced by a slightly longer MRI scan.