The new one-page tool can be completed about 20 minutes faster than the older form, but it is also more accurate, investigators said.
Investigators said they have developed an easier, more accurate way to track the progression of lupus in patients, simplifying the British Isles Lupus Assessment Group’s 2004 index (BILAG-2004) index down to a single-page assessment. The new tool was unveiled in a paper published in the journal Rheumatology.
Systemic lupus erythematosus (SLE) affects 1.5 million people in the United States, and is characterized by complex multisystem manifestations, noted the study’s corresponding author Edward M. Vital, PhD, of the Chapel Allerton Hospital in the United Kingdom, and colleagues.
As treatment of SLE has increasingly moved toward a treat-to-target approach, and as national guidelines for biologics have come to rely on disease response criteria, the ability to accurately track disease progression has become more and more important.
Multiple disease-activity tools have been developed, including the BILAG-2004. Yet, while existing tools have been repeatedly validated, they are also cumbersome and time-consuming.
Vital and colleagues wrote that the BILAG-2004 assessment relies on a complex network of scores, and that complexity introduces a significant risk of mistakes and errors.
“The current BILAG-2004 documentation relies on an index case report form, a detailed glossary of clinical items and a separate scoring algorithm for each of the 9 organ domains such that the overall A-E domain scores, notably renal and hematological, are frequently not available at the point of completing the case report form,” Vital and colleagues wrote.
The investigators therefore sought to create a new version of the tool that could accurately monitor disease progression without the time-consuming complexity of the current BILAG-2004.
They began by reviewing the frequency of items listed in the BILAG biologics registry. From there, they developed a series of prototypes for an easier form. Those were evaluated by 33 experts from 14 British medical centers for accuracy and usability and then validated against the BILAG-2004 assessment using 10 case vignettes.
The resulting tool was a one-page “Easy-BILAG.” It incorporates items that were present in at least 5% of cases in the registry, along with full constitutional and renal domains from the longer assessment. Color-coding and a glossary are available to help guide physicians, and a second page with rarer manifestation was developed for use in patients that require it.
The investigators said their new tool out-performed the accuracy of the BILAG-2004 tool, with a median scoring accuracy of 96.7% for the simpler tool, versus 87.8% for the longer form (P=.001).
General hospital rheumatologists were able to track progression accurately in 91.3% of cases with the newer version, versus 75% with the old form (P=.02). Inter-rater agreement was also higher.
The Easy-BILAG also saved time; on average, it took just under an hour to complete, compared with 80 minutes for the longer form.
In a press release, Vital said the tool should help streamline the important task of monitoring patient response to treatment.
“The standard-format BILAG is useful for assessing individual patients,” he said, “but its downside was always the time and training needed to complete it. Being able to measure the progress of lupus quickly and easily has transformed my practice so I’m excited that we can now make it easy for anyone to do the same.”
Carter LM, Gordon C, Yee C, et al. Easy-BILAG: a new tool for simplified recording of SLE disease activity using BILAG-2004 index. Rheumatology (Oxford). Published online January 25, 2022. doi:10.1093/rheumatology/keab883