Background Childhood-onset systemic lupus erythematosus (cSLE) occurs in approximately 20% of all SLE cases. cSLE is has a worse prognosis than adult-onset SLE, and often requires more aggressive therapy. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) coordinates a collaborative cSLE registry for patients in the US and Canada, while other active cSLE registries do so in the United Kingdom (UK JSLE Cohort) and throughout Europe (JIR PediaLup Registry). To date, differences in data fields and collection methodology have been a barrier to collaborative international research. Through collaborative efforts between CARRA and the Paediatric Rheumatology European Society (PReS), key ‘core’ and ‘expanded’ datasets have been developed through consensus with a focus on feasibility to conduct SLE research. Although consensus was reached on clinical and laboratory variables after the initial consensus meeting, uncertainty remained over how to best capture patient reported outcome measures (PROMs) including experiences of discrimination and disease- related symptoms.

Methods Following two expert taskforce meetings, a virtual consensus meeting was held in May 2023 to discuss (using adapted Nominal Group Technique) and vote (80% consensus required for agreement) on taskforce recommendations for PROM data elements to be included in the ‘expanded’ cSLE dataset. The voting panel consisted of 21 cSLE experts and three patient/parent partners, all of whom were provided the results of an extensive literature review and the input of taskforce participants.

Results The taskforce meetings established a goal of all PROMs being completable within 5–7 min. The PROM domains of fatigue, physical functioning, anxiety, depression, and experienced discrimination were selected as the most important by both patients and cSLE experts in the working groups. For the first five domains, the PROMIS short forms were selected due to extensive validation in different age groups and languages. Patients (teens and young adults diagnosed in childhood) provided key input that physical and mental fatigue should be measured separately as they may experience one without the other. Patients also expressed completing PROMs could induce a negative reaction, because questions remind them of limitations or missed experiences because of their disease. The Everyday Discrimination Scale (EDS) was selected to measure patient experiences of discrimination, given that this tool is the current research standard, has been validated in adolescents, and is available in many languages (table 1).

Conclusions Following an international cSLE expert voting panel, the consensus-based expanded dataset proposed for cSLE registries will include PROMs capturing critical aspects of the cSLE patient experience, including fatigue, physical functioning, anxiety, depression, and everyday discrimination. Inclusion of these PROMs in global cSLE registries will facilitate patient-oriented research for children and adolescents with SLE worldwide.