Abstract: TH-PO171

Enabling Large Observational Comparative Effectiveness Studies in Glomerular Disorders

Session Information

Category: Glomerular

  • 1005 Clinical Glomerular Disorders

Authors

  • Bhargava, Rhea, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
  • Agrawal, Nikhil, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
  • Stillman, Isaac Ely, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
  • Cabeza Rivera, Franco H., University of Mississippi Medical Center, Ridgeland, Mississippi, United States
  • Poyan-Mehr, Ali, None, Watertown, Massachusetts, United States
  • Brant, Elizabeth J., Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
  • Castaneda, Jorge Luis, None, Watertown, Massachusetts, United States
  • Friedman, David J., None, Watertown, Massachusetts, United States
  • Garg, Neetika, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
  • Germain, Michael J., Renal and Transplant Assoc of New England, Hampden, Massachusetts, United States
  • Pollak, Martin R., Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, United States
  • Schlondorff, Johannes S., Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
  • Singh, Tripti, None, Watertown, Massachusetts, United States
Background

The heterogeneous presentation of glomerulopathies contributes to ambiguity in diagnosis and management making large comparative studies difficult

Methods

We created a network of nephrologists and nephropathologists in private practice and academic institutions, leveraging collective power to enroll patients to conduct comparative effectiveness studies(The Glomerular Disease Study and Trial Consortium)

Results

Major requirements identified for registry
A Consensus on treatment standards & disease monitoring while preserving freedom of treatment selection
B Standardized follow up laboratory studies and evaluations at predefined intervals
C Review of tissue diagnosis by experienced nephropathologists, pathological work up and classification systems
D Cloud-based clinical data repository

A web-based, HIPAA secure system has been created for provider referral or patient self-referral for enrollment. Clinical data will be collected and updated quarterly. De-identified data will be available for research to collaborators.

Other opportunities:
Quality improvement measure development(e.g.TB surveillance, pregnancy counselling, diabetes, cancer screening)
Active surveillance for therapy-related adverse outcomes (e.g. quality of life, osteoporosis, infection, malignancy)

Conclusion

Developing a synchronized approach for treatment of glomerular disorders will permit large scale comparative effectiveness studies on observational data. We refer to this as “Open Source Clinical Trial” initiative, where each nephrologist may treat patients per individual decision making while following similar protocols,enabling comparative studies of different treatment strategies. www.glomcon.org