Development of CARRA/PReS-endorsed consensus Core and Expanded Datasets in childhood-onset systemic lupus erythematosus for international registry-based research.
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Ошибки и ограничения
История · было → стало
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Sadun Rebecca E, Cooper Jennifer C, Belot Alexandre, Avcin Tadej, Aggarwal Amita, Ainsworth Jenny, Akinsete Alisha, Ardoin Stacy P, Beresford Michael W, Bortey Lynette, Brunner Hermine I, Chang Joyce C, Ciurtin Coziana, Daftary Ashley, Eberhard Barbara, Feldman Candace H, Hedrich Christian M, Hersh Aimee O, Hiraki Linda T, Isenberg David A, Kamphuis Sylvia, Knight Andrea M, Lambert Lou, Levy Deborah M, Marks Stephen D, Maxwell Naomi, Migowa Angela, Moore Katharine, Ozen Seza, Ramsey-Goldman Rosalind, Ravelli Angelo, Reeve Bryce B, Rubinstein Tamar B, Saad-Magalhaes Claudia, Sawhney Sujata, Schanberg Laura E, von Scheven Emily, Scott Christiaan, Son Mary Beth, Tony Gladys, Weitzman Elissa R, Wenderfer Scott E, Woodside Alisha, Lewandowski Laura B, Smith Eve Md, CARRA SLE Committee and PReS Lupus Working Party
Аннотация
METHODS: 21 international cSLE experts and 4 patients participated in a Delphi process (questionnaires, 2 topic-specific focus groups and 3 virtual consensus meetings) to create 2 standardised 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 centres able to consistently collect data to address broader research questions. Final data items for the Core and Expanded datasets were determined by 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 adds 26 additional items and includes patient-reported outcomes. Consensus was also achieved regarding the frequency and time points for data collection: baseline, quarterly follow-up visits, annually and flare visits.
CONCLUSION: Standardised Core and Expanded cSLE Datasets for registry-based international cSLE research were defined through the consensus of global experts and patient/caregiver representatives, endorsed by CARRA and PReS. These datasets incorporate disease-specific and patient-specific features, optimised for diverse settings to facilitate international collaborative research for children and adolescents with SLE worldwide.