title: Validating Early Post-Transplant Outcomes Reported for Recipients of Deceased Donor Kidney Transplants.
abstract: OBJECTIVE
  Data reported to the Organ Procurement and Transplantation Network (OPTN) are used in kidney transplant research, policy development, and assessment of center quality, but the accuracy of early post-transplant outcome measures is unknown.
  
  
  METHODS
  The Deceased Donor Study (DDS) is a prospective cohort study at five transplant centers. Research coordinators manually abstracted data from electronic records for 557 adults who underwent deceased donor kidney transplantation between April of 2010 and November of 2013. We compared the post-transplant outcomes of delayed graft function (DGF; defined as dialysis in the first post-transplant week), acute rejection, and post-transplant serum creatinine reported to the OPTN with data collected for the DDS.
  
  
  RESULTS
  Median kidney donor risk index was 1.22 (interquartile range [IQR], 0.97-1.53). Median recipient age was 55 (IQR, 46-63) years old, 63% were men, and 47% were black; 93% had received dialysis before transplant. Using DDS data as the gold standard, we found that pretransplant dialysis was not reported to the OPTN in only 11 (2%) instances. DGF in OPTN data had a sensitivity of 89% (95% confidence interval [95% CI], 84% to 93%) and specificity of 98% (95% CI, 96% to 99%). Surprisingly, the OPTN data accurately identified acute allograft rejection in only 20 of 47 instances (n=488; sensitivity of 43%; 95% CI, 17% to 73%). Across participating centers, sensitivity of acute rejection varied widely from 23% to 100%, whereas specificity was uniformly high (92%-100%). Six-month serum creatinine values in DDS and OPTN data had high concordance (n=490; Lin concordance correlation =0.90; 95% CI, 0.88 to 0.92).
  
  
  CONCLUSIONS
  OPTN outcomes for recipients of deceased donor kidney transplants have high validity for DGF and 6-month allograft function but lack sensitivity in detecting rejection. Future studies using OPTN data may consider focusing on allograft function at 6 months as a useful outcome.
authors.affiliation: Department of Internal Medicine, Lankenau Medical Center, Wynnewood, Pennsylvania;
authors.forename: Vishnu S
authors.initials: VS
authors.lastname: Potluri
authors.affiliation: Program of Applied Translational Research, Department of Medicine and Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut; Veterans Affairs Connecticut Healthcare System, New Haven, Connecticut; Chirag.Parikh@Yale.edu.
authors.forename: Chirag R
authors.initials: CR
authors.lastname: Parikh
authors.affiliation: Program of Applied Translational Research, Department of Medicine and Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut;
authors.forename: Isaac E
authors.initials: IE
authors.lastname: Hall
authors.affiliation: Program of Applied Translational Research, Department of Medicine and.
authors.forename: Joseph
authors.initials: J
authors.lastname: Ficek
authors.affiliation: Wayne State University, Detroit, Michigan;
authors.forename: Mona D
authors.initials: MD
authors.lastname: Doshi
authors.affiliation: Program of Applied Translational Research, Department of Medicine and.
authors.forename: Isabel
authors.initials: I
authors.lastname: Butrymowicz
authors.affiliation: Saint Barnabas Medical Center, Livingston, New Jersey;
authors.forename: Francis L
authors.initials: FL
authors.lastname: Weng
authors.affiliation: Section of Nephrology, University Hospital, Ulm, Germany;
authors.forename: Bernd
authors.initials: B
authors.lastname: Schröppel
authors.affiliation: Division of Nephrology, Department of Medicine, Western University, London, Ontario, Canada; and.
authors.forename: Heather
authors.initials: H
authors.lastname: Thiessen-Philbrook
authors.affiliation: Renal-Electrolyte and Hypertension Division, Leonard Davis Institute for Health Economics, and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Peter P
authors.initials: PP
authors.lastname: Reese
mesh_terms: D000208:Acute Disease; D000328:Adult; D015415:Biomarkers / Q000097:blood; D003404:Creatinine / Q000097:blood; D016208:Databases, Factual; D051799:Delayed Graft Function / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis / Q000209:etiology*; D006801:Humans; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000379:methods; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D017064:Process Assessment, Health Care; D011446:Prospective Studies; D006435:Renal Dialysis; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D009927:Tissue and Organ Procurement; D016896:Treatment Outcome; D014481:United States
chemical_list: D015415:Biomarkers; D003404:Creatinine
keywords: acute rejection; adult; allografts; deceased donors; delayed graft function; humans; kidney transplantation; tissue and organ procurement; tissue donors; validation studies