POS0748 EASY-BILAG: A NEW TOOL FOR FASTER AND MORE ACCURATE RECORDING OF BILAG-2004 DISEASE ACTIVITY IN SLE
Authors: Carter L. M. , Gordon C. , Yee C. S. , Bruce I. N. , Isenberg D. , Skeoch S. , Vital E. 
Published: May 2021

Background:

BILAG-2004 index is an important disease activity instrument for SLE which is widely used in clinical trials and in treatment commissioning. It is more comprehensive and responsive than SLEDAI. However, BILAG-2004 may be difficult or time-consuming to complete during routine clinic visits. To derive the eventual scores from A (highly active) to E (no current or prior disease involvement) for each of the 9 organ domains, the current BILAG-2004 relies on a separate index form, glossary and scoring algorithm.

Objectives:

The Easy-BILAG project aimed to develop and validate a simplified tool for scoring the original BILAG-2004 index more rapidly and accurately in routine clinical care.

Methods:

Data from the UK BILAG-Biologics Registry (BILAG-BR) were used to measure the frequency with which the 97 BILAG-2004 clinical items occurred in a population with active SLE. These data and a series of prototypes were used to draft a new tool for simplified scoring of the BILAG-2004 index - the “Easy-BILAG”. After preliminary testing, a validation study was conducted to test accuracy, speed and usability of Easy-BILAG compared to the standard BILAG-2004 template. Rheumatologists and specialty trainees from centres around the UK were invited to score BILAG-2004 disease activity in a timed workbook of 10 exemplar case vignettes, using either Easy-BILAG or standard BILAG-2004 reference documents. The case vignettes tested clinicians in scoring both frequent and uncommon SLE manifestations as well as longitudinal scoring of items in flare and remission. All workbooks contained an overview and detailed instructions on BILAG-2004.

Results:

Among 2395 submissions to BILAG-BR the 6 most frequently scored clinical 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%). Twenty-five items were active in less than 1% of assessments. Easy-BILAG was therefore designed to enhance the visibility of the most frequently scored items and capture all clinical items scoring >5% in a rapid single-page assessment. All remaining, less common items, are scored, only when necessary, on a second page. Easy-BILAG incorporates an abridged glossary definition immediately adjacent to clinical each item. A new colour-blindness compatible, colour-coding system directs clinicians instantly to the overall A-E score for each domain.

In the validation exercise, clinicians were asked to identify active disease and assign BILAG-2004 scores, from A-E, for all 9 organ domains in a workbook of 10 case vignettes. Twenty clinicians, with a range of prior experience, have so far participated. Among clinicians working with the standard BILAG-2004 reference documents (n = 11), scoring 10 case vignettes took 90 +/- 9 minutes (mean +/- SEM) to complete. Clinicians using Easy-BILAG (n = 9) completed the exercise significantly faster at 66 +/- 8 minutes (p = 0.05). Crucially, Easy-BILAG yielded significantly higher percentage accuracy (mean +/- SEM) at 95.3 +/- 0.8 % across all domains, as compared with 81.8 +/- 6.2 % achieved by clinicians using standard BILAG-2004 documentation (p = 0.05). The difference was most apparent when specifically comparing accuracy across domains where the case exercises registered active disease. Here, Easy-BILAG showed no decline in accuracy at 94.9 +/- 1.0 % compared 75.7 +/- 5.3% achieved with standard BILAG-2004 documents (p = 0.005). In a usability survey, all (9/9) clinicians testing the Easy-BILAG template rated it as intuitive and simple to navigate.

Conclusion:

Easy-BILAG facilitates more rapid and accurate scoring of BILAG-2004 and provides a format which is amenable to use in routine clinical practice. Following completion of validation, it will be made widely available to clinicians.

Figure 1.

Illustration of the Easy-BILAG template shows format, colour scheme and method of scoring highest prevalence items mucocutaneous and musculoskeletal domain.

Disclosure of Interests:

Lucy Marie Carter: None declared, Caroline Gordon: None declared, Chee-Seng Yee: None declared, Ian N. Bruce Speakers bureau: GlaxoSmithKline, UCB Pharma, Consultant of: AstraZeneca, Eli Lilly, GlaxoSmithKline, ILTOO Pharma, MedImmune, Merck Serono, Grant/research support from: Genzyme Sanofi, GlaxoSmithKline, David Isenberg: None declared, Sarah Skeoch: None declared, Edward Vital Consultant of: Roche, GSK and AstraZeneca, Grant/research support from: GSK and AstraZeneca