Evaluating the accuracy of functional biomarkers for detecting histological changes in chronic allograft nephropathy

Transplant International

Volumn 20, Issue 7, 2007, Pages 608-615

  Yilmaz, Serdar ^a,b   Isik, Ipek ^b   Afrouzian, Marjan ^b   Monroy, Mauricio ^b   Sar, Aylin ^b   Benediktsson, Hallgrimur ^b   McLaughlin, Kevin ^b  

^a FOOTHILLS HOSPITAL   (Canada)

^b UNIVERSITY OF CALGARY   (Canada)

Author keywords

Chronic allograft damage index; Chronic allograft nephropathy; Estimated glomerular filtration rate; Protocol biopsy; Receiver operator characteristic curve analysis; Serum creatinine; Surrogate marker

Indexed keywords

BIOLOGICAL MARKER; CREATININE;

ADULT; ARTICLE; CHRONIC ALLOGRAFT NEPHROPATHY; CONFIDENCE INTERVAL; CONTROLLED STUDY; CORRELATION ANALYSIS; CREATININE BLOOD LEVEL; FEMALE; GLOMERULUS FILTRATION RATE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; KIDNEY BIOPSY; MAJOR CLINICAL STUDY; MALE; PREDICTION; PRIORITY JOURNAL; RECEIVER OPERATING CHARACTERISTIC;

ADULT; BIOLOGICAL MARKERS; CHRONIC DISEASE; CREATININE; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; KIDNEY; KIDNEY DISEASES; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; ROC CURVE; TRANSPLANTATION, HOMOLOGOUS;

EID: 34249911208     PISSN: 09340874     EISSN: 14322277     Source Type: Journal    
DOI: 10.1111/j.1432-2277.2007.00494.x     Document Type: Article

References (45)

1. Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med 2000 342 : 605.
2. Joosten SA, van Kooten C, Paul LC. Pathogenesis of chronic allograft rejection. Transpl Int 2003 16 : 137.
3. Fleming TR. Surrogate endpoints and FDA's accelerated approval process. Health Aff (Millwood) 2005 24 : 67.
4. Lachenbruch PA, Rosenberg AS, Bonvini E, Cavaille-Coll MW, Colvin RB. Biomarkers and surrogate endpoints in renal transplantation: present status and considerations for clinical trial design. Am J Transplant 2004 4 : 451.
5. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989 8 : 431.
6. Dimeny E, Wahlberg J, Larsson E, Fellstrom B. Can histopathological findings in early renal allograft biopsies identify patients at risk for chronic vascular rejection Clin Transplant 1995 9 : 79.
7. Fujisawa M, Ono H, Isotani S, et al. Significance of chronic transplant nephropathy on early protocol biopsies for graft outcome in pediatric renal transplantation. Transplant Proc 1999 31 : 1687.
8. Isoniemi HM, Krogerus L, von Willebrand E, Taskinen E, Ahonen J, Hayry P. Histopathological findings in well-functioning, long-term renal allografts. Kidney Int 1992 41 : 155.
9. Kasiske BL, Kalil RS, Lee HS, Rao KV. Histopathologic findings associated with a chronic, progressive decline in renal allograft function. Kidney Int 1991 40 : 514.
10. Nicholson ML, Bailey E, Williams S, Harris KP, Furness PN. Computerized histomorphometric assessment of protocol renal transplant biopsy specimens for surrogate markers of chronic rejection. Transplantation 1999 68 : 236.
11. Nicholson ML, McCulloch TA, Harper SJ, et al. Early measurement of interstitial fibrosis predicts long-term renal function and graft survival in renal transplantation. Br J Surg 1996 83 : 1082.
12. Nickerson P, Jeffery J, Gough J, et al. Identification of clinical and histopathologic risk factors for diminished renal function 2 years posttransplant. J Am Soc Nephrol 1998 9 : 482.
13. Seron D, Moreso F, Bover J, et al. Early protocol renal allograft biopsies and graft outcome. Kidney Int 1997 51 : 310.
14. Mota A, Arias M, Taskinen EI, et al. Sirolimus-based therapy following early cyclosporine withdrawal provides significantly improved renal histology and function at 3 years. Am J Transplant 2004 4 : 953.
15. Yilmaz S, Tomlanovich S, Mathew T, et al. Protocol core needle biopsy and histologic Chronic Allograft Damage Index (CADI) as surrogate end point for long-term graft survival in multicenter studies. J Am Soc Nephrol 2003 14 : 773.
16. Goldberg BB, Pollack HM, Kellerman E. Ultrasonic localization for renal biopsy. Radiology 1975 115 : 167.
17. Wiseman DA, Hawkins R, Numerow LM, Taub KJ. Percutaneous renal biopsy utilizing real time, ultrasonic guidance and a semiautomated biopsy device. Kidney Int 1990 38 : 347.
18. Furness PN, Philpott CM, Chorbadjian MT, et al. Protocol biopsy of the stable renal transplant: a multicenter study of methods and complication rates. Transplantation 2003 76 : 969.
19. Hergesell O, Felten H, Andrassy K, Kuhn K, Ritz E. Safety of ultrasound-guided percutaneous renal biopsy-retrospective analysis of 1090 consecutive cases. Nephrol Dial Transplant 1998 13 : 975.
20. Schwarz A, Gwinner W, Hiss M, Radermacher J, Mengel M, Haller H. Safety and adequacy of renal transplant protocol biopsies. Am J Transplant 2005 5 : 1992.
21. Hariharan S, McBride MA, Cherikh WS, Tolleris CB, Bresnahan BA, Johnson CP. Post-transplant renal function in the first year predicts long-term kidney transplant survival. Kidney Int 2002 62 : 311.
22. Salvadori M, Rosati A, Bock A, et al. One-year posttransplant renal function is a strong predictor of long-term kidney function: results from the Neoral-MOST Observational Study. Transplant Proc 2003 35 : 2863.
23. Siddiqi N, McBride MA, Hariharan S. Similar risk profiles for post-transplant renal dysfunction and long-term graft failure: UNOS/OPTN database analysis. Kidney Int 2004 65 : 1906.
24. Salvadori M, Rosati A, Bock A, et al. Estimated one-year glomerular filtration rate is the best predictor of long-term graft function following renal transplant. Transplantation 2006 81 : 202.
25. Katz MH. Common uses of multivariable models. In : Katz MH, ed. Multivariable Analysis. A Practical Guide for Clinicians. Cambridge, UK : Cambridge University Press, 1999 : 17 26.
26. Sharples LD. Statistical approaches to rational biomarker selection. In : Trull AK, Demers LM, Holt DW, Johnston A, Tredger JM, Price CP, eds. Biomarkers of Disease: An Evidence-Based Approach. Cambridge, UK : Cambridge University Press, 2002 : 24 31.
27. Lang TA, Secic M. Determining the presence or absence of disease. In : Lang TA, Secic M, eds. How to Report Statistics in Medicine Annotated Guidlines for Authors, Editors and Reviewers. Philadelphia, PA : American College of Physicians, 1997 : 147 169.
28. Begg CB. Advances in statistical methodology for diagnostic medicine in the 1980's. Stat Med 1991 10 : 1887.
29. Zweig MH, Campbell G. Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine. Clin Chem 1993 39 : 561.
30. Racusen LC, Solez K, Colvin RB, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999 55 : 713.
31. Isoniemi H, Taskinen E, Hayry P. Histological chronic allograft damage index accurately predicts chronic renal allograft rejection. Transplantation 1994 58 : 1195.
32. Yilmaz S, Yilmaz A, Hayry P. Chronic renal allograft rejection can be predicted by area under the serum creatinine versus time curve (AUCCr). Kidney Int 1995 48 : 251.
33. Cohen JA. A coefficient of agreement for nominal scales. Educ Psychol Meas 1960 20 : 37.
34. Bohmig GA, Regele H, Horl WH. Protocol biopsies after kidney transplantation. Transpl Int 2005 18 : 131.
35. Tesi RJ, Bailly JE, Schnitzler MA, Irish WD. Development of a surrogate marker of long-term kidney allograft outcome based on serum creatinine (sCr) and calculated creatinine clearance at 6 months post-transplant [abstract]. Am J Transplant 2002 2(Suppl.3) : 149.
36. McClish DK. Analyzing a portion of the ROC curve. Med Decis Making 1989 9 : 190.
37. Kaplan B, Schold J, Meier-Kriesche HU. Poor predictive value of serum creatinine for renal allograft loss. Am J Transplant 2003 3 : 1560.
38. Schuck O, Viklicky O, Voska L, et al. Predicting of histopathological grade of chronic allograft nephropathy from renal function and proteinuria. Ann Transplant 2003 8 : 5.
39. Cosio FG, Grande JP, Wadei H, Larson TS, Griffin MD, Stegall MD. Predicting subsequent decline in kidney allograft function from early surveillance biopsies. Am J Transplant 2005 5 : 2464.
40. Pilmore HL, Painter DM, Bishop GA, McCaughan GW, Eris JM. Early up-regulation of macrophages and myofibroblasts: a new marker for development of chronic renal allograft rejection. Transplantation 2000 69 : 2658.
41. Srinivas TR, Kubilis PS, Croker BP. Macrophage index predicts short-term renal allograft function and graft survival. Transpl Int 2004 17 : 195.
42. Jaeschke R, Guyatt GH, Sackett DL. Users' guides to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? The Evidence-Based Medicine Working Group. JAMA 1994 271 : 703.
43. Dinnes J, Deeks J, Kirby J, Roderick P. A methodological review of how heterogeneity has been examined in systematic reviews of diagnostic test accuracy. Health Technol Assess 2005 9 : 1.
44. Nierenberg AA, Feinstein AR. How to evaluate a diagnostic marker test. Lessons from the rise and fall of dexamethasone suppression test. JAMA 1988 259 : 1699.
45. Valenstein PN. Evaluating diagnostic tests with imperfect standards. Am J Clin Pathol 1990 93 : 252.