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BackgroundTreatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis.Methods and findingsIn a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of

Objective: Lupus disease measures such as the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group (BILAG) index are challenging to interpret. The Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) is intended to provide an efficient application of anchored visual analog scores, each representing the individual severity of active symptoms, with the sum of individual scores deriving an overall disease activity assessment. Our objective was to compare the performance of LFA-REAL to systemic lupus erythematosus disease activity assessments and compare scores between trained lupus clinical investigators and clinicians.Methods: Investigators scored the SLEDAI, BILAG, physician's global assessment (PGA), and LFA-REAL, while the clinicians scored the LFA-REAL. The level of agreement between physicians and instruments was determined.Results: The study included 99 patients (93% women, 31% white, mean ± SD ages 43.4 ± 13.2 years). At the first visit, the mean ± SD SLEDAI score was 5.5 ± 4.5, BILAG score 6.7 ± 7.8, and PGA score 33.6 ± 24.5. The mean ± SD investigator LFA-REAL score was 46.2 ± 42.9, and clinician LFA-REAL score 56.1 ± 53.6. At the second visit, the mean ± SD investigator LFA-REAL score was 41.3 ± 36.7, and clinician LFA-REAL score 48.3 ± 42.6. Total LFA-REAL scores correlated positively with PGA, SLEDAI, and BILAG (ρ = 0.58-0.88, P < 0.001). LFA-REAL scores produced correlation coefficients of ρ > 0.7 for musculoskeletal, mucocutaneous, and renal BILAG domains. The intraclass correlation coefficient between the LFA-REAL scores of investigators and clinicians was 0.79 for visit 1 (P < 0.001) and 0.86 for visit 2 (P < 0.001).Conclusion: The LFA-REAL provides a reliable surrogate for more complicated disease activity measures when used by lupus clinical investigators or clinicians. [ABSTRACT FROM AUTHOR]

The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus effort to identify, prioritise and address top barriers in lupus impacting diagnosis, care, treatment and research. To conduct this process, the ALPHA Project convened a multistakeholder Global Advisory Committee (GAC) of lupus experts and collected input from global audiences, including patients. In phase I, the ALPHA Project used expert interviews and a global survey of lupus experts to identify and categorise barriers into three overarching pillars: drug development, clinical care and access to care. In phase II, reported here, the GAC developed recommended actionable solutions to address these previously identified barriers through an in-person stakeholder meeting, followed by a two-round scoring process. Recommendations were assessed for feasibility, impact and timeline for implementation (FIT), where potential FIT component values were between 1 and 3 and total scores were between 3 and 9. Higher scores represented higher achievability based on the composite of the three criteria. Simplifying and standardising outcomes measures, including steroid sparing as an outcome (drug development) and defining the lupus spectrum (clinical care) ranked as the highest two priority solutions during the GAC meeting and received high FIT scores (7.67 and 7.44, respectively). Leveraging social media (access to care) received the highest FIT score across all pillars (7.86). Cross-cutting themes of many solutions include leveraging digital technology and applying specific considerations for special populations, including paediatrics. Implementing the recommendations to address key barriers to drug development, clinical care and access to care is essential to improving the quality of life of adults and children with lupus. Multistakeholder collaboration and guidance across existing efforts globally is warranted., Competing Interests: Competing interests: SCR is an employee of the Lupus Foundation of America (LFA). SS, LB, TF and DZ are consultants of Faegre Drinker Consulting, a division of Faegre Drinker Biddle & Reath, a law and consulting firm that represents patient advocacy organisations and sponsors developing drugs. INB receives grant/research support from Genzyme Sanofi, GSK and UCB; is a consultant of Eli Lilly, AstraZeneca, UCB, Iltoo and Merck Serono; and affiliated with speakers bureaus for UCB and AstraZeneca. EC-S is an employee of Mallinckrodt (former). KHC receives grant/research support from Merck and is a consultant of AstraZeneca. BD is an employee of Aurinia (former). TD receives grant/research support from Janssen, Novartis, Roche and UCB; is a consultant of Abbvie, Celgene, Eli Lilly, Roche, Janssen and EMD; and affiliated with speakers bureaus for Eli Lilly, Roche, Samsung and Janssen. KK receives grant/research support from UCB, Novartis and Resolve; and is a consultant of AstraZeneca, Viela Bio, Genentech/Roche, Biogen, Iltoo, GSK, BMS, Janssen, Abbvie, Amgen, Eli Lilly, Kyowa Kirin, Equillium Bio and Celgene. AHK is an employee of EMD Serono. EFM receives grant/research support from AstraZeneca, BMS, Eli Lilly, GSK, Janssen and Merck-Serono; is a consultant of AbbVie, Amgen, AstraZeneca, Biogen, BMS, Eli Lilly, GSK, Janssen, Neovacs and Sandoz; and is affiliated with speaker bureaus for AstraZeneca and Novartis. BHR is a consultant for GSK, Aurinia, AstraZeneca, Novartis, Alexion and BMS. LES receives grant/research support from Sobi, BMS, CARRA Inc.; is a consultant of Aurinia, UCB (DSMB), Sanofi (DSMB) and Sobi. VPW receives grant/research support from Biogen, Celgene, Gilead, Janssen and Viela; and is a consultant of Biogen, Gilead, Janssen, Abbvie, GSK, Resolve, AstraZeneca, Amgen, Eli Lilly, EMD Serono, BMS, Viela and Kyowa Kirin. JMVF is a shareholder and employee of GSK (former). KT and LMH are employees of the LFA (former). SE and AWD are LFA patient ambassadors., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)