Abstract

Abstract Background/Aims BILAG-2004 index is required to prescribe and monitor biologics in SLE. It is more comprehensive and responsive than the SLEDAI and widely used in clinical trials. However, it may be time-consuming and does require training for accurate use. The original format requires a separate index form, glossary and scoring algorithm. Further, the eventual scores from A (highly active) to E (no disease involvement) which are required to make treatment decisions, can be difficult to calculate during in routine clinical practice.The Easy-BILAG project aimed to develop and validate a simplified tool to score the original BILAG-2004 index more rapidly and with fewer errors, for use in routine clinical care. Methods The BILAG group identified four areas to address: (i) many items must be scored, but most are rare; (ii) glossary definitions are not always followed; (iii) the final score is not easily calculated at the time of assessment; (iv) training is time-consuming. Data from the BILAG-Biologics Registry were used to measure the frequency of each of 97 BILAG-2004 items in an active SLE population. These data and a series of prototypes were used to design a new tool for simplified scoring of the BILAG-2004 index - the “Easy-BILAG”. This instrument content was tested using exemplar paper cases. A validation study was then designed to test the Easy-BILAG compared to the standard BILAG-2004 scoring method for completion time and accuracy. Results 2395 assessments from the BILAG-BR were analysed. There was marked variation in item frequency. The 7 most frequent items were each present in more than 20% of records: arthralgia (72%), mild skin eruption (47%), moderate arthritis (38%), mild mucosal ulceration (34%), mild alopecia (34%), pleurisy / pericarditis (22%). 16 more items were scored in 5-20% of assessments; 36 items in 1-5% of assessments, and 25 items in < 1% of assessments. The Easy-BILAG was designed to capture items scoring >5% in a rapid single-page assessment. Items are arranged in a logical sequence of clinical assessment. An abridged glossary definition is cited immediately adjacent to each item. A new colour-coding system directs clinicians instantly to the overall A-E score for each domain (colour-blindness compatible). This single page assessment covered 68% of all assessments of biologic-treated patients. The remaining items are scored on a back page only in cases where necessary, as indicated by screening questions on the main page. The overall accuracy and usability of the Easy-BILAG template is now undergoing a validation against test series of standardized case vignettes by a sample of consultants and specialty trainees with a range of experience across England and Wales. Conclusion Easy-BILAG allows rapid scoring of BILAG-2004 in routine clinical practice. Following completion of validation, it will be made widely available to clinicians. Disclosure L.M. Carter: None. C. Gordon: None. C. Yee: None. I. Bruce: None. D.A. Isenberg: None. S. Skeoch: None. E.M. Vital: None.

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