Abstract Background and aims The EPITOME study (NCT06055725) evaluates how many stroke survivors with paresis develop post-stroke spasticity (PSS) that may benefit from medication within one-year. The study uses the 13-item Post-Stroke Spasticity Monitoring Questionnaire (PSMQ) for remote monitoring. This prespecified interim analysis measured predictiveness of PSMQ for spasticity detection. Methods Participants (18-85y) were recruited ≤4 weeks after first-ever stroke with paresis ≤2 weeks and completed the PSMQ at defined intervals. Participants whose PSMQ indicates possible spasticity (score ≥2) undergo a confirmatory assessment but continue monitoring if PSS is not clinically confirmed. For this analysis of the first 151 participants to reach month 3, all attended a clinic visit regardless of PSMQ score. Receiver operating characteristic (ROC) curve analyses evaluated which PSMQ items were most predictive of spasticity. Results PSMQ total scores remained low median 0-1 throughout the first three months of follow-up. Overall 65.6% (99/151) had a PSMQ score of ≥2, and 45.7% (69/151) had confirmed PSS. The sensitivity of the PSMQ was 81% but specificity was 48%. ROCAUCanalysis revealed item predictiveness: Q1(stiffness/tightness) and Q2(difficulty bending/flexing limb): 0.66; Q6(symptoms 1 month): 0.61. Other items had an ROCAUC of ≤0.60. Simplifying the PMSQ to Q1 and Q2 retained tool predictiveness (ROCAUC of 0.69 with items 1+2 vs 0.66 with PSMQ-total score) while reducing the burden of questionnaire completion. Conclusions 45.7% of stroke survivors with paresis developed PSS within 3 months. A simplified tool using PMSQ Q1+Q2 will be used in the study to improve monitoring while reducing patient burden. Conflict of interest Richard D. Zorowitz, Laura Serrano Barrenechea, Simon Butet, David Hernández Herrero, Rama Prasad, and Alessandro Picelli are investigators for the EPITOME study, sponsored by Ipsen. Pascal Lecomte and Sophie Vandenbremt act as patient and caregiver advisors for Ipsen. Mathieu Beneteau, Pascal Maisonobe, and Simon Page are employed by Ipsen. Figure 1 - belongs to Results
Zorowitz et al. (Fri,) studied this question.