ORIGINAL ARTICLE   Free access

European Journal of Physical and Rehabilitation Medicine 2021 February;57(1):92-100

DOI: 10.23736/S1973-9087.20.06189-4

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Development of a new patient-reported outcome measure assessing activities and participation in people with lumbar spinal stenosis: The Cochin Spinal Stenosis 19-item questionnaire

Chiara MASI ^{1, 2}, Gaelle COURAUD ^{1, 3}, Camille DASTE ^{1, 3, 4}, Jennifer JOUFFRIAULT ¹, Serge POIRAUDEAU ^{1, 3, 4, 5}, Marie-Martine LEFÈVRE-COLAU ^{1, 3, 4, 5}, Francois RANNOU ^{1, 4, 6}, Christelle NGUYEN ^{1, 4, 6} ✉

¹ Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Assistance Publique-Hôpitaux de Paris (AP-HP), Cochin Hospital, Paris, France; ² Unit of Physical Medicine and Rehabilitation, Rizzoli Orthopedic Institute, Bologna, Italy; ³ Department of Medicine, Faculty of Health, University of Paris, Paris, France; ⁴ INSERM UMR-S 1153, Center for Epidemiology and Statistics Research, University of Paris, Paris, France; ⁵ Federal Institute for Disability Research, Paris, France; ⁶ INSERM UMR-S 1124, Environmental Toxicity Laboratory, Therapeutic Targets, Cell Signaling and Biomarkers (T3S), Campus Saint-Germain-des Prés, Paris, France

BACKGROUND: Lumbar spinal stenosis (LSS) is the leading cause of spinal surgery in people over 65-years old. In people with LSS, generic self-administered questionnaires are the most commonly used PROs to assess health-related quality of life, global activity limitation, and low back pain-located activity limitation.
AIM: The aim was to develop a new patient-reported outcome measure assessing activities and participation in people with LSS.
DESIGN: Observation, prospective and qualitative study.
SETTING: For the qualitative study, were enrolled in- and outpatients with LSS from 2 French tertiary care centers (Department of PRM of Cochin Hospital and Department of Rheumatology of Limoges Hospital). For the Internet E-survey, screened the electronic medical records of the Department of PRM of Cochin Hospital.
POPULATION: From February to April 2018 were enrolled patients older than 50-years and symptomatic LSS.
METHODS: We used a 2-step approach. In a first step, we conducted a qualitative study using in-depth semi-structured interviews in 20 patients with LSS to collect meaningful concepts and to develop a provisional questionnaire. In a second step, using the provisional questionnaire, we conducted an Internet E-survey in an independent sample of 200 patients with LSS.
RESULTS: Concepts collected from patients generated a 48-item provisional questionnaire. Overall, 63/200 (31.5%) patients completed the provisional questionnaire. Item reduction resulted in a 19-item questionnaire, the Cochin Spinal Stenosis 19-item (CSS-19) questionnaire. Principal component analysis extracted 3 factors. In confirmatory analysis, factor 1 influenced all items. We found convergent validity with low back pain, LSS-specific disability and divergent validity with mental health-related quality of life. Cronbach α coefficient (95% CI) was 0.96 (0.94; 0.97). ICC was 0.90 (0.70; 0.97). Bland and Altman analysis found no systematic trend for test-retest.
CONCLUSIONS: CSS-19 is a new patient-reported outcome measure assessing activities and participation in people with LSS. Its construction prioritized patients’ perspectives at all stages. Its content and construct validities are good.
CLINICAL REHABILITATION IMPACT: Instruments able to capture specific needs of people with LSS in terms of activities and participation are lacking.

KEY WORDS: Lumbar stenosis, familial; Spinal stenosis; Disability evaluation