POS1139 LUPUS DAMAGE INDEX REVISION – ITEM GENERATION AND REDUCTION PHASE
Authors: B. Kundakci, M. Barber, A. E. Clarke, S. R. Johnson, I. N. Bruce
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> The Systemic Lupus International Collaborating Clinics (SLICC), the American College of Rheumatology (ACR) and the Lupus Foundation of America (LFA) collaboratively embarked on a project to develop a revised Systemic Lupus Erythematosus (SLE) Damage Index (SDI), employing a structured methodology including five key phases: updating the construct of damage (I), item generation (II), item reduction (III), item weighting and threshold determination (IV), and the assessment of validation and reliability (V). This initiative aims to address limitations of the current SDI, [1] notably incomplete items, restricted applicability in paediatric patients, and outdated item definitions, through a data- and expert/patient-driven approach. <h3>Objectives:</h3> To report the item generation and reduction phase results of a five-phase process for developing a revised SDI. <h3>Methods:</h3> Item generation included a literature review and a first Delphi round. Item reduction involved a two further Delphi rounds. In the third Delphi round, items with a median score of ≤ 4 out of 9 were excluded. Items remaining at this stage were assessed by a 14-member steering committee and items were removed if they were assessed by a clear majority (&gt;70%) to a) not reflect the damage construct [2] and/or b) an excessively rare events and/or c) not widely feasible to formally assess. Remaining items were then reviewed by expert organ domain groups for further refinement including whether certain items could be clustered into a single item and to identify if any grading/severity could be included for relevant items. <h3>Results:</h3> A cohort of 146 individuals from 35 countries, broadly reflecting the lupus research and patient community, was established. Our literature review identified 4 (1.8%) unique items, while 103 (46.8%) were unique to the Delphi process, and 113 (51.4%) items overlapped both processes. After the second Delphi round, Delphi participants suggested an additional 6 unique items. As a result, we had 226 items for review by our third Delphi round where 36 items scoring ≤ 4 out of 9 were removed. Our expert steering committee removed 126 items due to redundancy, limited feasibility for assessment, overlap, inadequate reflection of damage construct, or association with lupus disease activity, and rarity. This included all items in a proposed 'reproduction and pregnancy' domain reducing the number of organ domains to 13. Subsequently, the expert organ domain groups reviewed the candidate items, leading to a final total of 45 items (Figure 1). Eleven items from the previous SDI, including chronic peritonitis, muscle atrophy or weakness, and osteomyelitis, were removed. Additionally, several new items were proposed, such as growth failure/reduced final height and adrenal insufficiency. Moreover, several items had proposed gradings of severity, including cardiomyopathy and chronic kidney disease. <h3>Conclusion:</h3> Using a combined data-driven and expert/patient-based approach, items and domains that comprise damage in SLE have been expanded. The item generation and reduction phase resulted in 45 candidate items to be taken forward to the next stages. Further steps are now underway to make final refinements to the proposed items, agree item definitions, including severity grading (where appropriate) and duration of item presence, based on the best current evidence and internationally accepted norms. <h3>REFERENCES:</h3> [1] Gladman D. et al. (1996). The development and initial validation of the SLICC/ACR damage index for SLE. <i>Arthritis Rheumatol.</i> [2] Johnson, S. R et al. (2021). Evaluating the construct of damage in SLE. <i>Arthritis Care Res.</i> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> Burak Kundakci: None declared, Megan Barber AbbVie, AstraZeneca, GSK, Janssen, Sanofi-Genzyme, Ann E. Clarke AstraZeneca, GSK, BMS, GSK, Sindhu R. Johnson: None declared, Ian N. Bruce UCB, Astra Zeneca, Janssen and GSK, Astra Zeneca, UCB, Aurinia, Takeda, GSK, Lilly, Horizon Therapeutics, Dragonfly Therapeutics, Astra Zeneca, GSK, Janssen, Novartis, and on behalf of the Revised Systemic Lupus Erythematosus Organ Damage Index Collaborators: None declared.