Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol
Introduction Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of systemic sclerosis. Despite this, lcSSc is not the major focus of clinical studies. The lack of interventional studies in lcSSc is due, in part, to a paucity of relevant outcome measures to effectively evaluate...
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doaj-d806a9fec068477f9eb78372285890442021-07-02T13:04:40ZengBMJ Publishing GroupBMJ Open2044-60552021-03-0111310.1136/bmjopen-2020-044765Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocolMaya H Buch0John D Pauling1Michael Hughes2Alain Lescoat3David Roofeh4Whitney Townsend5Robert D Sandler6François Zimmermann7Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UKDepartment of Rheumatology, Royal National Hospital For Rheumatic Diseases (at Royal United Hospitals), University of Bath, Bath, UKDepartment of Rheumatology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UKInternal Medicine & Clinical Immunology, CHU Rennes, Rennes, FranceScleroderma Program, University of Michigan, Ann Arbor, Michigan, USATaubman Health Sciences Library, University of Michigan, Ann Arbor, Michigan, USADepartment of Rheumatology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UKInternal Medicine & Clinical Immunology, CHU Rennes, Rennes, FranceIntroduction Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of systemic sclerosis. Despite this, lcSSc is not the major focus of clinical studies. The lack of interventional studies in lcSSc is due, in part, to a paucity of relevant outcome measures to effectively evaluate this subset. A combined response index dedicated to lcSSc would facilitate development of well-designed trials and approval of new drugs. The objective of this scoping review is to perform a broad and comprehensive identification of the outcome measures (core set items) within relevant domains, which have been used so far to assess lcSSc.Methods and analysis The planned scoping review will be based on the approach proposed by Arksey et al and further developed by Levac et al. Development and reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews checklist and guidelines. The development of the search strategy was guided by the concepts of domains and outcomes based on the Outcome Measures in Rheumatology approach and by the different names and definitions of SSc, with a specific emphasis on their occurrence in clinical trial studies. Two databases will be searched: MEDLINE and Embase. Studies in English, published from the year 1988 onwards, will be included, since 1988 corresponds to the publication of LeRoy’s first consensus definition of lcSSc. Data will be extracted and analysed using a standardised charting tool.Ethics and dissemination No ethical approval is required for this study. The results will be submitted to an international peer-reviewed journal and scientific conferences, informing the discussion on which items should be included in a combined response index dedicated to lcSSc (the CRISTAL project: Combined Response Index for Scleroderma Trial Assessing lcSSc).https://bmjopen.bmj.com/content/11/3/e044765.full |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Maya H Buch John D Pauling Michael Hughes Alain Lescoat David Roofeh Whitney Townsend Robert D Sandler François Zimmermann |
spellingShingle |
Maya H Buch John D Pauling Michael Hughes Alain Lescoat David Roofeh Whitney Townsend Robert D Sandler François Zimmermann Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol BMJ Open |
author_facet |
Maya H Buch John D Pauling Michael Hughes Alain Lescoat David Roofeh Whitney Townsend Robert D Sandler François Zimmermann |
author_sort |
Maya H Buch |
title |
Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol |
title_short |
Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol |
title_full |
Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol |
title_fullStr |
Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol |
title_full_unstemmed |
Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol |
title_sort |
domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol |
publisher |
BMJ Publishing Group |
series |
BMJ Open |
issn |
2044-6055 |
publishDate |
2021-03-01 |
description |
Introduction Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of systemic sclerosis. Despite this, lcSSc is not the major focus of clinical studies. The lack of interventional studies in lcSSc is due, in part, to a paucity of relevant outcome measures to effectively evaluate this subset. A combined response index dedicated to lcSSc would facilitate development of well-designed trials and approval of new drugs. The objective of this scoping review is to perform a broad and comprehensive identification of the outcome measures (core set items) within relevant domains, which have been used so far to assess lcSSc.Methods and analysis The planned scoping review will be based on the approach proposed by Arksey et al and further developed by Levac et al. Development and reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews checklist and guidelines. The development of the search strategy was guided by the concepts of domains and outcomes based on the Outcome Measures in Rheumatology approach and by the different names and definitions of SSc, with a specific emphasis on their occurrence in clinical trial studies. Two databases will be searched: MEDLINE and Embase. Studies in English, published from the year 1988 onwards, will be included, since 1988 corresponds to the publication of LeRoy’s first consensus definition of lcSSc. Data will be extracted and analysed using a standardised charting tool.Ethics and dissemination No ethical approval is required for this study. The results will be submitted to an international peer-reviewed journal and scientific conferences, informing the discussion on which items should be included in a combined response index dedicated to lcSSc (the CRISTAL project: Combined Response Index for Scleroderma Trial Assessing lcSSc). |
url |
https://bmjopen.bmj.com/content/11/3/e044765.full |
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