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.

Adult Aged Female Humans Male Middle Aged Minimal Clinically Important Difference Patient Reported Outcome Measures Patient Satisfaction Physical Therapy Modalities Scleroderma, Systemic / drug therapy
Minimal clinically important difference Patient acceptable symptom state Patient-reported outcomes Systemic sclerosis

Journal

Seminars in arthritis and rheumatism
ISSN: 1532-866X
Titre abrégé: Semin Arthritis Rheum
Pays: United States
ID NLM: 1306053

Informations de publication

Date de publication:
02 2019
Historique:
received: 03 02 2018
revised: 10 03 2018
accepted: 23 03 2018
pubmed: 25 4 2018
medline: 24 4 2019
entrez: 25 4 2018
Statut: ppublish

Résumé

To estimate patient acceptable symptom state (PASS) and minimal clinically important difference (MCID) for patient-reported outcomes in systemic sclerosis (SSc). 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. 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. We provide, for the first time, the PASS and MCID estimates for pain and activity limitation in SSc. ClinicalTrials.gov Identifier: NCT00318188. First Posted: April 26, 2006.

Sections du résumé

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.

Identifiants

DOI: 10.1016/j.semarthrit.2018.03.013 PMID: 29685482
pubmed: 29685482
pii: S0049-0172(18)30063-5
doi: 10.1016/j.semarthrit.2018.03.013
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT00318188']

Types de publication

Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

694-700

Informations de copyright

Copyright © 2018 Elsevier Inc. All rights reserved.

Auteurs

Camille Daste (C)

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; INSERM UMR 1153, Centre de Recherche Épidémiologie et Statistique Paris Sorbonne Cité, ECaMO Team, Paris, France.

François Rannou (F)

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; Sorbonne Paris Cité, Université Paris Descartes, Faculté de Médecine, Paris, France; INSERM UMR 1124, Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, Faculté des Sciences Fondamentales et Biomédicales, Centre Universitaire des Saints-Pères, Paris, France.

Luc Mouthon (L)

Sorbonne Paris Cité, Université Paris Descartes, Faculté de Médecine, Paris, France; AP-HP, Service de Médecine Interne, Centre de Référence des Maladies Rares, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France.

Katherine Sanchez (K)

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.

Alexandra Roren (A)

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; INSERM UMR 1153, Centre de Recherche Épidémiologie et Statistique Paris Sorbonne Cité, ECaMO Team, Paris, France.

Vincent Tiffreau (V)

Université Lille 2, Lille, France; Service de Médecine Physique et de Réadaptation, CHU de Lille, Lille, France.

Éric Hachulla (É)

Université Lille 2, Lille, France; Service de Médecine Interne, Centre de Référence des Maladies Auto-immunes et Systémiques Rares, CHU de Lille, Lille, France.

Philippe Thoumie (P)

Sorbonne Paris Cité, Université Paris Pierre et Marie Curie, Faculté de Médecine, Paris, France; AP-HP, Service de Médecine Physique et de Réadaptation, Hôpital Rothschild, Paris, France.

Jean Cabane (J)

AP-HP, Service de Médecine Interne, Hôpital Saint-Antoine, Paris, France.

Emmanuel Chatelus (E)

Hôpitaux Universitaires de Strasbourg, Service de Rhumatologie, Hôpital Hautepierre, Fédération de Médecine Translationnelle de Strasbourg, Strasbourg, France; INSERM UMR 1109, Université de Strasbourg, Strasbourg, France.

Jean Sibilia (J)

Hôpitaux Universitaires de Strasbourg, Service de Rhumatologie, Hôpital Hautepierre, Fédération de Médecine Translationnelle de Strasbourg, Strasbourg, France; INSERM UMR 1109, Université de Strasbourg, Strasbourg, France.

Serge Poiraudeau (S)

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; INSERM UMR 1153, Centre de Recherche Épidémiologie et Statistique Paris Sorbonne Cité, ECaMO Team, Paris, France; Sorbonne Paris Cité, Université Paris Descartes, Faculté de Médecine, Paris, France; Institut Fédératif de Recherche sur le Handicap, Paris, France.

Christelle Nguyen (C)

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; Sorbonne Paris Cité, Université Paris Descartes, Faculté de Médecine, Paris, France; INSERM UMR 1124, Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, Faculté des Sciences Fondamentales et Biomédicales, Centre Universitaire des Saints-Pères, Paris, France. Electronic address: christelle.nguyen2@aphp.fr.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Évaluation des résultats des patients › Pertinence clinique › Différence minimale cliniquement importante › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes sur les soins de santé › Mesures des résultats rapportés par les patients › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Satisfaction des patients › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Thérapeutique › Techniques de physiothérapie › Patient acceptable symptom state and minimal...
questionsmedicales.fr › Maladies de la peau et du tissu conjonctif › Maladies de la peau › Sclérodermie systémique › Patient acceptable symptom state and minimal...