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A 32-year-old woman with established systemic lupus erythematosus and recent biopsy findings consistent with lupus nephritis presents at a nephrology-rheumatology clinic to discuss potential enrollment in a comparative-effectiveness research study. What clinical and trial design factors are important when enrolling patients with kidney involvement due to autoimmune disease? How can studies ensure meaningful and broadly applicable results for everyday clinical care? VIDEO INFO Category: Lupus Nephritis Clinical Trials, Lupus Nephritis: Diagnosis and Management, Glomerulonephritis: Causes, Diagnosis, and Management, Nephrology: Kidney Disease Diagnosis and Management Difficulty: Moderate - Intermediate level - Requires solid foundational knowledge Question Type: Epidemiology Case Type: Routine Visit - Standard clinical encounter in outpatient setting Explore more ways to learn on this and other topics by going to https://endlessmedical.academy/auth?h... QUESTION A 32-year-old woman with biopsy-proven systemic lupus erythematosus (malar rash, arthritis, anti-double-stranded DNA positive) attends a routine nephrology-rheumatology clinic visit to consider participation in a pragmatic lupus nephritis comparative-effectiveness study. Vitals: pulse 63 bpm, temperature 37.3 degreesC, respirations 11/min, blood pressure 129/81 mm Hg, oxygen saturation 90% (baseline at altitude after a recent upper-respiratory infection).... OPTIONS A. Consecutive biopsy-confirmed class III/IV/V across community and academic sites; central randomization; blinded 12-month composite (UPCR =0.5 g/g, stable eGFR); intention-to-treat with class/proteinuria stratification. B. Recruit only tertiary-center referrals with UPCR =2.0 g/g and recent hospitalizations to hasten events; rely on site-reported outcomes without central adjudication to cut costs and speed follow-up. C. Use an online registry opt-in sample and include self-reported dipstick protein at 6 months; accept biopsies up to 5 years old to widen eligibility and reduce screening workload. D. Limit to new class IV cases on a repeat biopsy within 30 days and exclude community sites; define success as 50% proteinuria reduction at 24 weeks without an eGFR requirement. CORRECT ANSWER A. Consecutive biopsy-confirmed class III/IV/V across community and academic sites; central randomization; blinded 12-month composite (UPCR =0.5 g/g, stable eGFR); intention-to-treat with class/proteinuria stratification. EXPLANATION The correct answer is "Consecutive biopsy-confirmed class III/IV/V across community and academic sites; central randomization; blinded 12-month composite (UPCR =0.5 g/g, stable eGFR); intention-to-treat with class/proteinuria stratification." Consecutive capture across diverse practice settings minimizes selection bias and improves external validity. Requiring recent biopsy-confirmed ISN/RPS class III/IV/V standardizes diagnosis, while centralized randomization and blinded endpoint adjudication limit performance and ascertainment biases. An ITT analysis preserves randomization benefits.... Further reading: Links to sources are provided for optional further reading only. The questions and explanations are independently authored and do not reproduce or adapt any specific third-party text or content. --------------------------------------------------- Our cases and questions come from the https://EndlessMedical.Academy quiz engine - multi-model platform. Each question and explanation is forged by consensus between multiple top AI models (i.e. Open AI GPT, Claude, Grok, etc.), with automated web searches for the latest research and verified references. Calculations (e.g. eGFR, dosages) are checked via code execution to eliminate errors, and all references are reviewed by several AIs to minimize hallucinations. Important note: This material is entirely AI-generated and has not been verified by human experts; despite stringent consensus checks, perfect accuracy cannot be guaranteed. Exercise caution - always corroborate the content with trusted references or qualified professionals, and never apply information from this content to patient care or clinical decisions without independent verification. Clinicians already rely on AI and online tools - myself included - so treat this content as an additional focused aid, not a replacement for proper medical education. Visit https://endlessmedical.academy for more AI-supported resources and cases. This material can not be treated as medical advice. May contain errors. ---------------------------------------------------