Sadun, Rebecca;
Cooper, Jennifer;
Belot, Alessandre;
Ciurtin, Coziana;
Lewandowski, Laura;
Smith, Eve;
(2024)
Development of CARRA/PReS-Endorsed Consensus Core and Expanded Datasets in Childhood-Onset Systemic Lupus Erythematosus for International Registry-Based Research.
Annals of the Rheumatic Diseases
(In press).
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Abstract
Objectives: Childhood-onset systemic lupus erythematosus (cSLE), representing 15-20% of individuals with SLE, has been difficult to study globally due to differences between registries. This initiative, supported by Childhood Arthritis Rheumatology Research Alliance (CARRA) and Paediatric Rheumatology European Society (PReS), aims to create Core and Expanded cSLE Datasets to standardize and enhance research worldwide.// Methods: Twenty-one international cSLE experts and four patients engaged in a Delphi process (questionnaires, two topic-specific focus groups, and three virtual consensus meetings) to create two standardized cSLE datasets. The Core cSLE Dataset was designed to include data essential to meaningful clinical research across many settings. The Expanded cSLE Dataset was designed for centers able to consistently collect data to address broader research questions. Final data items for the Core and Expanded datasets were determined (consensus defined as >80% agreement) using an adapted nominal group technique and voting.// Results: The resulting Core cSLE Dataset contains 46 items, including demographics, clinical features, laboratory results, medications, and significant adverse events. The Expanded cSLE Dataset contains 26 additional items and is inclusive of patient-reported outcomes (PROs). Consensus was also achieved regarding the frequency and time points for data collection: baseline, quarterly follow-up visits, annually, and at flare visits.// Conclusion: Standardized Core and Expanded cSLE Datasets for registry-based international cSLE research were defined through consensus of global experts and patient/caregiver representatives, endorsed by CARRA and PReS. These datasets incorporate disease- and patient-specific features, optimized for diverse settings to facilitate international collaborative research for children and adolescents with SLE worldwide.
| Type: | Article |
|---|---|
| Title: | Development of CARRA/PReS-Endorsed Consensus Core and Expanded Datasets in Childhood-Onset Systemic Lupus Erythematosus for International Registry-Based Research |
| Open access status: | An open access version is available from UCL Discovery |
| Publisher version: | https://ard.bmj.com/ |
| Language: | English |
| Additional information: | This version is the author-accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10198271 |
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