The lead investigator noted that “the study results are a promising step toward having a scientifically-validated tool for clinical use that can facilitate physician-patient conversations and ultimately help to get ahead of MS progression.”
Tjalf Ziemssen, MD
The results of a recent validation study of an innovative, algorithm-based, digital solution tool developed by Novartis, dubbed MSProDiscuss, have shown that the tool has potential to aid in the evaluation and discussion surrounding early signs suggestive of progression in clinical practice of multiple sclerosis (MS).1
According to Novartis, MSProDiscuss tool was developed in cooperation with Adelphi Values, with the aim of supporting and facilitating a conversation between patients with MS and their providers who are in the midst of transitioning or have transitioned, to secondary progressive MS (SPMS) from relapsing-remitting MS (RRMS). The goal of this is to help improve the diagnosis of secondary disease—a challenge in itself—and thus prevent the further permanent damage from the condition.
Ultimately, in an assessment which included 20 neurologists and 198 patients with a diagnosis of RRMS, SPMS, or in a suspected transition period to SPMS, mean scores on the tool for patients with SPMS, patients suspected to be progressing SPMS, and patients with RRMS were 69.6, 55.2, and 38.1, respectively (P <.001).2
"One of the greatest challenges in MS is diagnosing the transition from RRMS to SPMS as the course of the disease is unique for every MS patient," said Tjalf Ziemssen, MD, professor of Clinical Neuroscience, head, Multiple Sclerosis Center and Neuroimmunological Laboratory, and director, Division of Neurometabolism, University Clinic Carl-Gustav Carus, and study investigator, in a statement. "The study results are a promising step toward having a scientifically-validated tool for clinical use that can facilitate physician-patient conversations and ultimately help to get ahead of MS progression."
Physicians progressed through a series of weighted questions in tandem with their patients, based on their clinical experiences in the prior 6 months. These questions sought to gather data on the patient’s disease’s symptomatic impact on their daily life and activities, which the algorithm—developed with a mixed methods approach involving qualitative research with patients and clinicians, and regression on data from a large real-world observational study (n = 2791)—which provided a visual output represented by a traffic light for the physician’s use in simplifying the patient-provider discussion.
Specifically, the tool asks for information such as patient age, Expanded Disability Status Scale (EDSS) score, presence of relapses in the prior 6 months, and whether or not MRI has been performed in that time frame. From there, the symptoms it inquiries about included visual, motor, ambulatory, coordination/balance, pain, sensory, bladder/bowel, speech, cognition, and fatigue.
All told, a threshold of ≥58.85 identified patients with SPMS with 82% sensitivity and 84% specificity (area under the ROC curve [AUC], 0.904; 95% CI, 0.86 to 0.95). Patients with RRMS were identified with a threshold of ≤51.80, with 83% sensitivity and 82% specificity, while a threshold of ≤53.85 had 89% sensitivity and 76% specificity when using the sum of squares and Youden’s J index, respectively (AUC, 0.908; 95% CI, 0.87 to 0.95).
Novartis noted that the MSProDiscuss tool is in its final development stage and is undergoing pilot-testing in several US centers. Its worldwide rollout is anticipated to be in early 2020. The tool is housed on neuro-compass, the independent educational MS site, and can be accessed here: MSProDiscuss.
"With this innovative digital tool, we aim to reimagine clinical practice for neurologists and MS patients,” said Danny Bar-Zohar, Global Head of Neuroscience Development, Novartis Pharmaceuticals. “Through harnessing high-quality data and analytics, MSProDiscussTM was developed in collaboration with renowned MS researchers, physicians and patients and is a testament to the Novartis commitment to improving the lives of MS patients beyond the development of drugs."
Ziemssen and colleagues noted that the results of the study “demonstrate that the SPMS screening tool was able to differentiate between RRMS and SPMS patients with high sensitivity and specificity and thus also identify patients in transition.”
The literature suggests that up to 80% of patients with RRMS transition to SPMS, at which point the disease’s impact can lead to issues such as continuous functional decline (which is often undiagnosed or diagnosed only retrospectively). As a result, the investigators wrote that these data support both the validity and potential clinical utility of the tool to help recognize early signs suggestive of progressive MS.
The study’s findings were presented at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania.
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1. Novartis presents first-of-its-kind algorithm-based tool to help MS patients and physicians evaluate and discuss early signs of progression to secondary progressive MS [press release]. Basel, Switzerland: Novartis; Published May 7, 2019. novartis.com/news/media-releases/novartis-presents-first-its-kind-algorithm-based-tool-help-ms-patients-and-physicians-evaluate-and-discuss-early-signs-progression-secondary-progressive-ms. Accessed May 14, 2019.
2. Ziemssen T, Meier DP, Bennett B, et al. Validation of the Scoring Algorithm for a Novel Integrative Secondary Progressive Multiple Sclerosis (SPMS) Screening Tool. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, PA.