Daniel Sumpton1,2,3, Adrien Bigot4, Benedicte Sautenet5, Jonathan C Craig6, Geraldine Hassett7, Vivek Thakkar7,8, Peter Tugwell9, Allison Tong1,2. 1. Sydney School of Public Health, The University of Sydney, Sydney, Australia. 2. Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia. 3. Department of Rheumatology, Concord Hospital, Sydney, Australia. 4. Service de Médecine Interne, Hôpital Bretonneau, CHRU Tours, Tours, France. 5. Service de Néphrologie, Hôpital Bretonneau, CHRU Tours, Université de Tours et Nantes, SPHERE- INSERM 1246, Tours, France. 6. College of Medicine and Public Health, Flinders University, Adelaide, Australia. 7. Department of Rheumatology, Liverpool Hospital, Sydney, Australia. 8. Department of Clinical Medicine, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia. 9. Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute.
Abstract
OBJECTIVE: The core outcome set for trials in systemic sclerosis (SSc) was developed in 2008 and comprises eleven domains and thirty-one measures, leading to the development of a composite index (CRISS). We aimed to assess the scope, and consistency of outcomes reported in trials of SSc, and the uptake of this core set and CRISS. METHODS: MEDLINE, Cochrane CENTRAL, Embase and clinicaltrials gov were searched to identify randomized trials published from 2000 to 29 April 2018 in adults with limited or diffuse SSc. Outcomes and measures were recorded for each trial, classified into domains and the frequency of outcomes before after publication of the publication of the core set calculated. RESULTS: From 152 trials, 4193 outcomes were classified into 84 domains. The three most common domains were health-related quality of life and function (59%, 130 measures), skin (47%, 59 measures) and pulmonary (45%, 168 measures). After the publication of the core outcome set, no trial reported the complete core set with adherence to each of the eleven domains ranging from 6.1% to 54.4% and adherence to each of the thirty-one measures ranging from 0 to 48.1%. The five measures required for CRISS were reported completely in 11% of trials. CONCLUSION: Despite recognition that uniform acquisition and reporting of outcomes would enable a better evaluation of proposed SSc therapeutics, the outcome domains and measures reported in randomized trials in systemic sclerosis remain very inconsistent, with little impact of the core outcome set. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
OBJECTIVE: The core outcome set for trials in systemic sclerosis (SSc) was developed in 2008 and comprises eleven domains and thirty-one measures, leading to the development of a composite index (CRISS). We aimed to assess the scope, and consistency of outcomes reported in trials of SSc, and the uptake of this core set and CRISS. METHODS: MEDLINE, Cochrane CENTRAL, Embase and clinicaltrials gov were searched to identify randomized trials published from 2000 to 29 April 2018 in adults with limited or diffuse SSc. Outcomes and measures were recorded for each trial, classified into domains and the frequency of outcomes before after publication of the publication of the core set calculated. RESULTS: From 152 trials, 4193 outcomes were classified into 84 domains. The three most common domains were health-related quality of life and function (59%, 130 measures), skin (47%, 59 measures) and pulmonary (45%, 168 measures). After the publication of the core outcome set, no trial reported the complete core set with adherence to each of the eleven domains ranging from 6.1% to 54.4% and adherence to each of the thirty-one measures ranging from 0 to 48.1%. The five measures required for CRISS were reported completely in 11% of trials. CONCLUSION: Despite recognition that uniform acquisition and reporting of outcomes would enable a better evaluation of proposed SSc therapeutics, the outcome domains and measures reported in randomized trials in systemic sclerosis remain very inconsistent, with little impact of the core outcome set. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
Authors: Alain Lescoat; Susan L Murphy; Yen T Chen; Nadia Vann; Francesco Del Galdo; David Cella; Maya H Buch; Dinesh Khanna Journal: Semin Arthritis Rheum Date: 2021-11-07 Impact factor: 5.431
Authors: Alain Lescoat; Susan L Murphy; David Roofeh; John D Pauling; Michael Hughes; Robert Sandler; François Zimmermann; Rachel Wessel; Whitney Townsend; Lorinda Chung; Christopher P Denton; Peter A Merkel; Virginia Steen; Yannick Allanore; Francesco Del Galdo; Dominique Godard; David Cella; Sue Farrington; Maya H Buch; Dinesh Khanna Journal: J Scleroderma Relat Disord Date: 2020-10-05