Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care |
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| Authors: | Camille Daste François Rannou Luc Mouthon Katherine Sanchez Alexandra Roren Vincent Tiffreau Éric Hachulla Philippe Thoumie Jean Cabane Emmanuel Chatelus Jean Sibilia Serge Poiraudeau Christelle Nguyen |
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| Institution: | 1. AP-HP, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France;2. INSERM UMR 1153, Centre de Recherche Épidémiologie et Statistique Paris Sorbonne Cité, ECaMO Team, Paris, France;3. Sorbonne Paris Cité, Université Paris Descartes, Faculté de Médecine, Paris, France;4. INSERM UMR 1124, Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, Faculté des Sciences Fondamentales et Biomédicales, Centre Universitaire des Saints-Pères, Paris, France;5. AP-HP, Service de Médecine Interne, Centre de Référence des Maladies Rares, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France;6. Université Lille 2, Lille, France;7. Service de Médecine Physique et de Réadaptation, CHU de Lille, Lille, France;8. Service de Médecine Interne, Centre de Référence des Maladies Auto-immunes et Systémiques Rares, CHU de Lille, Lille, France;9. Sorbonne Paris Cité, Université Paris Pierre et Marie Curie, Faculté de Médecine, Paris, France;10. AP-HP, Service de Médecine Physique et de Réadaptation, Hôpital Rothschild, Paris, France;11. AP-HP, Service de Médecine Interne, Hôpital Saint-Antoine, Paris, France;12. Hôpitaux Universitaires de Strasbourg, Service de Rhumatologie, Hôpital Hautepierre, Fédération de Médecine Translationnelle de Strasbourg, Strasbourg, France;13. INSERM UMR 1109, Université de Strasbourg, Strasbourg, France;14. Institut Fédératif de Recherche sur le Handicap, Paris, France |
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| Abstract: | BackgroundTo estimate patient acceptable symptom state (PASS) and minimal clinically important difference (MCID) for patient-reported outcomes in systemic sclerosis (SSc).MethodsWe conducted a secondary analysis of the SCLEREDUC trial, a 12-month randomized controlled trial comparing the efficacy of physical therapy to usual care in 220 SSc patients followed-up from September 2005 to October 2010. Self-rated state and change in patient health at 12 months were assessed by using 2 external anchors extracted from the Medical Outcomes Study 36-Item Short-Form. Patients who self-rated their health as “excellent”, “very good” or “good” were the PASS group and those who self-rated their health change as “somewhat better” were the MCID group. Main outcomes were the estimates of PASS by using the 75th percentile method and of MCID by using the mean change in scores method for pain and activity limitation.ResultsPASS (95% confidence interval) and mean (SD) MCID estimates at 12 months were 53.75 (34.00 to 68.00) and ?6.74 (32.02) for the joint-pain visual analog scale (range 0–100), 1.41 (1.13 to 1.63) and ?0.21 (0.48) for the Health Assessment Questionnaire (HAQ, range 0–3), 1.27 (1.07 to 1.62) and ?0.13 (0.45) for the scleroderma HAQ (range 0–3), 26.00 (17.00 to 37.00) and -3.38 (9.87) for the Cochin Hand Function Scale (range 0–90), and 19.40 (17.20 to 21.90) and ?5.69 (6.79) for the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (range 0–30), respectively.ConclusionsWe provide, for the first time, the PASS and MCID estimates for pain and activity limitation in SSc.Trial registrationClinicalTrials.gov Identifier: NCT00318188. First Posted: April 26, 2006. |
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| Keywords: | HAQ health assessment questionnaire sHAQ scleroderma health assessment questionnaire MACTAR McMaster-Toronto Arthritis Patient Preference Disability Questionnaire MCID minimal clinically important difference PASS patient acceptable symptom state SD standard deviation SF-36 Medical Outcomes Study 36-Item Short Form Systemic sclerosis Patient-reported outcomes Patient acceptable symptom state Minimal clinically important difference |
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