Validation of the Italian version of a patient-reported outcome measure for Hereditary Spastic Paraplegia

Author:

Diella EleonoraORCID,D’Angelo Maria Grazia,Stefan Cristina,Girardi Giulia,Morganti Roberta,Martinuzzi Andrea,Biffi Emilia

Abstract

Background and aim Patient-reported outcome measures (PROMs) are recognized as valuable measures in the clinical setting. In 2018 we developed the Italian version of the “Hereditary Spastic Paraplegia-Self Notion and Perception Questionnaire” (HSP-SNAP), a disease-specific questionnaire that collects personal perception on motor symptoms related to HSP such as stiffness, weakness, imbalance, reduced endurance, fatigue and pain. In this study our primary aim was to assess the questionnaire validity and reliability. Our secondary aim was to characterize the symptoms “perceived” by patients with HSP and compare them with those “perceived” by age-matched healthy subjects. Methods The 12-item HSP-SNAP questionnaire was submitted to 20 external judges for comprehensibility and to 15 external judges for content validity assessment. We recruited 40 subjects with HSP and asked them to fill the questionnaire twice for test-retest procedure. They also completed the Medical Outcome Survey Short Form (SF-36) and were evaluated by the Spastic Paraplegia Rating Scale and the Six-Minute Walk Test. We also recruited 44 healthy subjects who completed the HSP-SNAP once to test score variability. Results The HSP-SNAP content validity index was high (0.8±0.1) and the test-retest analysis showed high reliability (ICC = 0.94). The mean HSP-SNAP score (score range 0–48) of the HSP group was 22.2±7.8, which was significantly lower than healthy subjects (43.1±6.3). The most commonly perceived symptom was stiffness, followed by weakness and imbalance. Conclusion Although HSP-SNAP does not investigate non-motor symptoms and we validated only its Italian version, it showed good validity and reliability and it could be used in combination with other objective outcome measures for clinical purposes or as endpoints for future clinical rehabilitation studies. Trial registration Trial Registration: ClinicalTrial.gov, NCT04256681. Registered 3 February 2020.

Funder

Fondazione Cariplo

Regione Lombardia

Ministero della Salute

Publisher

Public Library of Science (PLoS)

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