PMID- 29685482 OWN - NLM STAT- MEDLINE DCOM- 20190423 LR - 20190423 IS - 1532-866X (Electronic) IS - 0049-0172 (Linking) VI - 48 IP - 4 DP - 2019 Feb TI - 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. PG - 694-700 LID - S0049-0172(18)30063-5 [pii] LID - 10.1016/j.semarthrit.2018.03.013 [doi] AB - BACKGROUND: To estimate patient acceptable symptom state (PASS) and minimal clinically important difference (MCID) for patient-reported outcomes in systemic sclerosis (SSc). METHODS: We 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. RESULTS: PASS (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. CONCLUSIONS: We provide, for the first time, the PASS and MCID estimates for pain and activity limitation in SSc. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00318188. First Posted: April 26, 2006. CI - Copyright (c) 2018 Elsevier Inc. All rights reserved. FAU - Daste, Camille AU - Daste C AD - AP-HP, Service de Reeducation et de Readaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hopitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France; INSERM UMR 1153, Centre de Recherche Epidemiologie et Statistique Paris Sorbonne Cite, ECaMO Team, Paris, France. FAU - Rannou, Francois AU - Rannou F AD - AP-HP, Service de Reeducation et de Readaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hopitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France; Sorbonne Paris Cite, Universite Paris Descartes, Faculte de Medecine, Paris, France; INSERM UMR 1124, Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, Faculte des Sciences Fondamentales et Biomedicales, Centre Universitaire des Saints-Peres, Paris, France. FAU - Mouthon, Luc AU - Mouthon L AD - Sorbonne Paris Cite, Universite Paris Descartes, Faculte de Medecine, Paris, France; AP-HP, Service de Medecine Interne, Centre de Reference des Maladies Rares, Hopitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France. FAU - Sanchez, Katherine AU - Sanchez K AD - AP-HP, Service de Reeducation et de Readaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hopitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France. FAU - Roren, Alexandra AU - Roren A AD - AP-HP, Service de Reeducation et de Readaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hopitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France; INSERM UMR 1153, Centre de Recherche Epidemiologie et Statistique Paris Sorbonne Cite, ECaMO Team, Paris, France. FAU - Tiffreau, Vincent AU - Tiffreau V AD - Universite Lille 2, Lille, France; Service de Medecine Physique et de Readaptation, CHU de Lille, Lille, France. FAU - Hachulla, Eric AU - Hachulla E AD - Universite Lille 2, Lille, France; Service de Medecine Interne, Centre de Reference des Maladies Auto-immunes et Systemiques Rares, CHU de Lille, Lille, France. FAU - Thoumie, Philippe AU - Thoumie P AD - Sorbonne Paris Cite, Universite Paris Pierre et Marie Curie, Faculte de Medecine, Paris, France; AP-HP, Service de Medecine Physique et de Readaptation, Hopital Rothschild, Paris, France. FAU - Cabane, Jean AU - Cabane J AD - AP-HP, Service de Medecine Interne, Hopital Saint-Antoine, Paris, France. FAU - Chatelus, Emmanuel AU - Chatelus E AD - Hopitaux Universitaires de Strasbourg, Service de Rhumatologie, Hopital Hautepierre, Federation de Medecine Translationnelle de Strasbourg, Strasbourg, France; INSERM UMR 1109, Universite de Strasbourg, Strasbourg, France. FAU - Sibilia, Jean AU - Sibilia J AD - Hopitaux Universitaires de Strasbourg, Service de Rhumatologie, Hopital Hautepierre, Federation de Medecine Translationnelle de Strasbourg, Strasbourg, France; INSERM UMR 1109, Universite de Strasbourg, Strasbourg, France. FAU - Poiraudeau, Serge AU - Poiraudeau S AD - AP-HP, Service de Reeducation et de Readaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hopitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France; INSERM UMR 1153, Centre de Recherche Epidemiologie et Statistique Paris Sorbonne Cite, ECaMO Team, Paris, France; Sorbonne Paris Cite, Universite Paris Descartes, Faculte de Medecine, Paris, France; Institut Federatif de Recherche sur le Handicap, Paris, France. FAU - Nguyen, Christelle AU - Nguyen C AD - AP-HP, Service de Reeducation et de Readaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hopitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France; Sorbonne Paris Cite, Universite Paris Descartes, Faculte de Medecine, Paris, France; INSERM UMR 1124, Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, Faculte des Sciences Fondamentales et Biomedicales, Centre Universitaire des Saints-Peres, Paris, France. Electronic address: christelle.nguyen2@aphp.fr. LA - eng SI - ClinicalTrials.gov/NCT00318188 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180327 PL - United States TA - Semin Arthritis Rheum JT - Seminars in arthritis and rheumatism JID - 1306053 SB - IM MH - Adult MH - Aged MH - Female MH - Humans MH - Male MH - Middle Aged MH - Minimal Clinically Important Difference MH - Patient Reported Outcome Measures MH - Patient Satisfaction MH - *Physical Therapy Modalities MH - Scleroderma, Systemic/drug therapy/*therapy OTO - NOTNLM OT - Minimal clinically important difference OT - Patient acceptable symptom state OT - Patient-reported outcomes OT - Systemic sclerosis EDAT- 2018/04/25 06:00 MHDA- 2019/04/24 06:00 CRDT- 2018/04/25 06:00 PHST- 2018/02/03 00:00 [received] PHST- 2018/03/10 00:00 [revised] PHST- 2018/03/23 00:00 [accepted] PHST- 2018/04/25 06:00 [pubmed] PHST- 2019/04/24 06:00 [medline] PHST- 2018/04/25 06:00 [entrez] AID - S0049-0172(18)30063-5 [pii] AID - 10.1016/j.semarthrit.2018.03.013 [doi] PST - ppublish SO - Semin Arthritis Rheum. 2019 Feb;48(4):694-700. doi: 10.1016/j.semarthrit.2018.03.013. Epub 2018 Mar 27.