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Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers

(2014) NEPHROLOGY DIALYSIS TRANSPLANTATION. 29(11). p.2054-2061
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Abstract
Acute kidney injury (AKI) remains a deadly condition. Tissue inhibitor of metalloproteinases (TIMP)-2 and insulin-like growth factor binding protein (IGFBP)7 are two recently discovered urinary biomarkers for AKI. We now report on the development, and diagnostic accuracy of two clinical cutoffs for a test using these markers. We derived cutoffs based on sensitivity and specificity for prediction of Kidney Disease: Improving Global Outcomes Stages 2-3 AKI within 12 h using data from a previously published multicenter cohort (Sapphire). Next, we verified these cutoffs in a new study (Opal) enrolling 154 critically ill adults from six sites in the USA. One hundred subjects (14%) in Sapphire and 27 (18%) in Opal met the primary end point. The results of the Opal study replicated those of Sapphire. Relative risk (95% CI) in both studies for subjects testing at a parts per thousand currency sign0.3 versus > 0.3-2 were 4.7 (1.5-16) and 4.4 (2.5-8.7), or 12 (4.2-40) and 18 (10-37) for a parts per thousand currency sign0.3 versus > 2. For the 0.3 cutoff, sensitivity was 89% in both studies, and specificity 50 and 53%. For 2.0, sensitivity was 42 and 44%, and specificity 95 and 90%. Urinary [TIMP-2]aEuro cent[IGFBP7] values of 0.3 or greater identify patients at high risk and those > 2 at highest risk for AKI and provide new information to support clinical decision-making.
Keywords
acute renal failure, acute kidney injury, biomarkers, insulin-like growth factor binding protein (IGFBP)7 and tissue inhibitor of metalloproteinases (TIMP)-2, sensitivity and specificity (MeSH), ACUTE KIDNEY INJURY, RENAL-FUNCTION, MORTALITY, TRIAL, PROGNOSIS, DIAGNOSIS, FAILURE, SURGERY, CURVES

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Citation

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MLA
Hoste, Eric, Peter A McCullough, Kianoush Kashani, et al. “Derivation and Validation of Cutoffs for Clinical Use of Cell Cycle Arrest Biomarkers.” NEPHROLOGY DIALYSIS TRANSPLANTATION 29.11 (2014): 2054–2061. Print.
APA
Hoste, Eric, McCullough, P. A., Kashani, K., Chawla, L. S., Joannidis, M., Shaw, A. D., Feldkamp, T., et al. (2014). Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. NEPHROLOGY DIALYSIS TRANSPLANTATION, 29(11), 2054–2061.
Chicago author-date
Hoste, Eric, Peter A McCullough, Kianoush Kashani, Lakhmir S Chawla, Michael Joannidis, Andrew D Shaw, Thorsten Feldkamp, et al. 2014. “Derivation and Validation of Cutoffs for Clinical Use of Cell Cycle Arrest Biomarkers.” Nephrology Dialysis Transplantation 29 (11): 2054–2061.
Chicago author-date (all authors)
Hoste, Eric, Peter A McCullough, Kianoush Kashani, Lakhmir S Chawla, Michael Joannidis, Andrew D Shaw, Thorsten Feldkamp, Denise L Uettwiller-Geiger, Paul McCarthy, Jing Shi, Michael G Walker, and John A Kellum. 2014. “Derivation and Validation of Cutoffs for Clinical Use of Cell Cycle Arrest Biomarkers.” Nephrology Dialysis Transplantation 29 (11): 2054–2061.
Vancouver
1.
Hoste E, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, et al. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. NEPHROLOGY DIALYSIS TRANSPLANTATION. 2014;29(11):2054–61.
IEEE
[1]
E. Hoste et al., “Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers,” NEPHROLOGY DIALYSIS TRANSPLANTATION, vol. 29, no. 11, pp. 2054–2061, 2014.
@article{5815154,
  abstract     = {Acute kidney injury (AKI) remains a deadly condition. Tissue inhibitor of metalloproteinases (TIMP)-2 and insulin-like growth factor binding protein (IGFBP)7 are two recently discovered urinary biomarkers for AKI. We now report on the development, and diagnostic accuracy of two clinical cutoffs for a test using these markers. 
We derived cutoffs based on sensitivity and specificity for prediction of Kidney Disease: Improving Global Outcomes Stages 2-3 AKI within 12 h using data from a previously published multicenter cohort (Sapphire). Next, we verified these cutoffs in a new study (Opal) enrolling 154 critically ill adults from six sites in the USA. 
One hundred subjects (14%) in Sapphire and 27 (18%) in Opal met the primary end point. The results of the Opal study replicated those of Sapphire. Relative risk (95% CI) in both studies for subjects testing at a parts per thousand currency sign0.3 versus > 0.3-2 were 4.7 (1.5-16) and 4.4 (2.5-8.7), or 12 (4.2-40) and 18 (10-37) for a parts per thousand currency sign0.3 versus > 2. For the 0.3 cutoff, sensitivity was 89% in both studies, and specificity 50 and 53%. For 2.0, sensitivity was 42 and 44%, and specificity 95 and 90%. 
Urinary [TIMP-2]aEuro cent[IGFBP7] values of 0.3 or greater identify patients at high risk and those > 2 at highest risk for AKI and provide new information to support clinical decision-making.},
  author       = {Hoste, Eric and McCullough, Peter A and Kashani, Kianoush and Chawla, Lakhmir S and Joannidis, Michael and Shaw, Andrew D and Feldkamp, Thorsten and Uettwiller-Geiger, Denise L and McCarthy, Paul and Shi, Jing and Walker, Michael G and Kellum, John A},
  issn         = {0931-0509},
  journal      = {NEPHROLOGY DIALYSIS TRANSPLANTATION},
  keywords     = {acute renal failure,acute kidney injury,biomarkers,insulin-like growth factor binding protein (IGFBP)7 and tissue inhibitor of metalloproteinases (TIMP)-2,sensitivity and specificity (MeSH),ACUTE KIDNEY INJURY,RENAL-FUNCTION,MORTALITY,TRIAL,PROGNOSIS,DIAGNOSIS,FAILURE,SURGERY,CURVES},
  language     = {eng},
  number       = {11},
  pages        = {2054--2061},
  title        = {Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers},
  url          = {http://dx.doi.org/10.1093/ndt/gfu292},
  volume       = {29},
  year         = {2014},
}

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