Validation of a Set of Clinical Criteria for the Diagnosis of Secondary Progressive Multiple Sclerosis

Abstract

Background/Objectives: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by progressive impairment of neuronal transmission due to focal demyelination. The most common form is RRMS (relapsing-remitting multiple sclerosis), which, under the influence of certain factors, can progress to SPMS (secondary progressive multiple sclerosis). Our study aimed to validate the criteria proposed by a working group of the Romanian Society of Neurology versus the criteria proposed by a group of experts from Spain, Karolinska, and Croatia concerning the progression from RRMS to SPMS. Methods: This was done by gathering epidemiological data (age, gender) and by applying clinical tests such as the 9HPT (9-hole peg test), 25FWT (25-foot walk test), and EDSS (expanded disability status scale) tests and the SDMT test (symbol digit modalities test). The present research is a cohort study that included a number of 120 patients diagnosed with MS according to the McDonald Diagnostic Criteria 2017. The study was carried out between January 2023 and April 2024, including patients hospitalized in the Neurology Clinic of the Clinical Rehabilitation Hospital from Iasi, Romania. The data were collected at baseline (T0) and at a 12-month interval (T1). Results: The statistical analysis was conducted using Kaiser-Meyer-Olkin analysis, which indicated a value of 0.683, thus validating the clinical tests used. The correlation matrix and the linear regression for all the tests showed highly significant statistical results. Furthermore, the ROC curve analysis of the criteria suggested by the working group of the Romanian Society of Neurology demonstrated that the EDSS, 9HPT, and 25FWT are highly sensitive in diagnosing SPMS, an opinion that is shared with the Spanish experts, but not with the Karolinska expert panel. Using the criteria given by the Croatian expert group in the ROC curve analysis showed that only the EDSS was strongly significant for the progression to the SPMS phase. Conclusions: In conclusion, all clinical methods used demonstrated that they are valid and can contribute to identifying patients with an increased risk of progression. The model proposed by the Romanian Society of Neurology working group is similar to other countries' expert opinions and can be used to detect the risk of disease progression and establish a more tailored therapeutic management of SPMS.

Keywords: disease progression; expert consensus; multiple sclerosis; validation criteria.

Figure 1

Regression line regarding the correlation between the EDSS score at T0 and T1.

Figure 2

Regression line regarding the correlation at T0 and T1 for 9HPT, 25 FWT, and SDMT.

Figure 2

Regression line regarding the correlation at T0 and T1 for 9HPT, 25 FWT, and SDMT.

Figure 3

ROC curve in relation to the types of ”events” that define the form of SPMS according to the criteria of the working group of the Romanian Society of Neurology.

Figure 4

The ROC curve in relation to the types of “events” that define the type of the SPMS according to the criteria of the Spanish “expert” group.

Figure 5

The ROC curve in relation to the types of ”event” that define the type of SPMS according to the Karolinka expert group criteria.

Figure 6

The ROC curve in relation to the types of “events” that define the shape of the SPMS according to the criteria of the Croatian expert group.