title: Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients.
abstract: Registry-based clinical research in nephrolithiasis is critical to advancing quality in urinary stone disease management and ultimately reducing stone recurrence. A need exists to develop Health Insurance Portability and Accountability Act (HIPAA)-compliant registries that comprise integrated electronic health record (EHR) data using prospectively defined variables. An EHR-based standardized patient database-the Registry for Stones of the Kidney and Ureter (ReSKU™)-was developed, and herein we describe our implementation outcomes.
  
  
  
  Interviews with academic and community endourologists in the United States, Canada, China, and Japan identified demographic, intraoperative, and perioperative variables to populate our registry. Variables were incorporated into a HIPAA-compliant Research Electronic Data Capture database linked to text prompts and registration data within the Epic EHR platform. Specific data collection instruments supporting New patient, Surgery, Postoperative, and Follow-up clinical encounters were created within Epic to facilitate automated data extraction into ReSKU.
  
  
  
  The number of variables within each instrument includes the following: New patient-60, Surgery-80, Postoperative-64, and Follow-up-64. With manual data entry, the mean times to complete each of the clinic-based instruments were (minutes) as follows: New patient-12.06 ± 2.30, Postoperative-7.18 ± 1.02, and Follow-up-8.10 ± 0.58. These times were significantly reduced with the use of ReSKU structured clinic note templates to the following: New patient-4.09 ± 1.73, Postoperative-1.41 ± 0.41, and Follow-up-0.79 ± 0.38. With automated data extraction from Epic, manual entry is obviated.
  
  
  
  ReSKU is a longitudinal prospective nephrolithiasis registry that integrates EHR data, lowering the barriers to performing high quality clinical research and quality outcome assessments in urinary stone disease.
authors.affiliation: 1 Department of Urology, University of California San Francisco , San Francisco, California.
authors.forename: Helena C
authors.initials: HC
authors.lastname: Chang
authors.affiliation: 1 Department of Urology, University of California San Francisco , San Francisco, California.
authors.forename: David T
authors.initials: DT
authors.lastname: Tzou
authors.affiliation: 1 Department of Urology, University of California San Francisco , San Francisco, California.|2 Division of Urology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital , Bangkok, Thailand .
authors.forename: Manint
authors.initials: M
authors.lastname: Usawachintachit
authors.affiliation: 3 Department of Urology, Oregon Health and Science University , Portland, Oregon.
authors.forename: Brian D
authors.initials: BD
authors.lastname: Duty
authors.affiliation: 1 Department of Urology, University of California San Francisco , San Francisco, California.
authors.forename: Ryan S
authors.initials: RS
authors.lastname: Hsi
authors.affiliation: 4 Department of Urology, University of Washington , Seattle, Washington.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Harper
authors.affiliation: 4 Department of Urology, University of Washington , Seattle, Washington.
authors.forename: Mathew D
authors.initials: MD
authors.lastname: Sorensen
authors.affiliation: 1 Department of Urology, University of California San Francisco , San Francisco, California.
authors.forename: Marshall L
authors.initials: ML
authors.lastname: Stoller
authors.affiliation: 5 Department of Urology, University of California San Diego , La Jolla, California.
authors.forename: Roger L
authors.initials: RL
authors.lastname: Sur
authors.affiliation: 1 Department of Urology, University of California San Francisco , San Francisco, California.
authors.forename: Thomas
authors.initials: T
authors.lastname: Chi
mesh_terms: D001331:Automation; D035843:Biomedical Research; D002170:Canada; D002681:China; D003625:Data Collection; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007391:International Cooperation; D007564:Japan; D007668:Kidney; D007669:Kidney Calculi / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012042:Registries; D014481:United States; D014513:Ureter; D014514:Ureteral Calculi / Q000453:epidemiology*; D053039:Ureterolithiasis; D052878:Urolithiasis
keywords: prospective studies; registries; urolithiasis