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A 32-year-old woman with lupus nephritis at an altitude clinic, stable kidney function, and ongoing immunosuppression, recently recovered from a respiratory infection, is considered for a comparative-effectiveness research study. What key aspects of her clinical presentation and background should inform your approach to trial recruitment and endpoint selection? How can study design be optimized to ensure findings remain widely applicable to diverse patient populations? 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 systemic lupus erythematosus and a biopsy 6 months ago showing ISN/RPS class IV-G (active/chronic) attends a routine nephrology-rheumatology visit to discuss participation in a pragmatic comparative-effectiveness study. She lives at altitude and recently recovered from an upper-respiratory infection. She is not pregnant. Current medicines: hydroxychloroquine 200 mg twice daily, mycophenolate mofetil 1,000 mg twice daily, prednisone 10 mg daily, and calcium/vitamin D.... OPTIONS A. Consecutive adults at community and academic sites; recent biopsy-confirmed III/IV/V; central randomization; blinded 12-month endpoint (UPCR =0.5 g/g, stable eGFR) with adjudication; ITT with class/proteinuria stratification. B. Recruit tertiary-center referrals with UPCR =2.0 g/g and recent hospitalizations only; rely on unadjudicated site-reported outcomes to minimize costs, accelerate timelines, and accept heterogeneous adherence patterns explicitly. C. Use an online opt-in registry with self-reported dipstick protein at 6 months and accept kidney biopsies up to 5 years old to broaden eligibility, reduce screening, and waive remote record verification. D. Restrict 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 eGFR requirements or safety lab thresholds. CORRECT ANSWER A. Consecutive adults at community and academic sites; recent biopsy-confirmed III/IV/V; central randomization; blinded 12-month endpoint (UPCR =0.5 g/g, stable eGFR) with adjudication; ITT with class/proteinuria stratification. EXPLANATION A pragmatic LN trial should enhance external validity by enrolling consecutive adults across community and academic sites with recent biopsy-confirmed class III/IV/V disease, while preserving core trial quality through centralized randomization, blinded adjudication of a clinically meaningful endpoint (e.g., UPCR =0.5 g/g with stable eGFR at 12 months), and intention-to-treat analysis with prespecified stratification by class and proteinuria.... 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. ---------------------------------------------------