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

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...

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Vydáno v:	Nephrology, dialysis, transplantation Ročník 29; číslo 11; s. 2054
Hlavní autoři:	Hoste, Eric A J, McCullough, Peter A, Kashani, Kianoush, Chawla, Lakhmir S, Joannidis, Michael, Shaw, Andrew D, Feldkamp, Thorsten, Uettwiller-Geiger, Denise L, McCarthy, Paul, Shi, Jing, Walker, Michael G, Kellum, John A
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England 01.11.2014
Témata:	Acute Kidney Injury - pathology Acute Kidney Injury - urine Aged Biomarkers - urine Cell Cycle Checkpoints - physiology Female Follow-Up Studies Humans Insulin-Like Growth Factor Binding Proteins - urine Male Middle Aged Predictive Value of Tests ROC Curve Tissue Inhibitor of Metalloproteinase-2 - urine insulin-like growth factor binding protein (IGFBP)7 and tissue inhibitor of metalloproteinases (TIMP)-2 acute kidney injury acute renal failure sensitivity and specificity (MeSH) biomarkers
ISSN:	1460-2385, 1460-2385
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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 ≤0.3 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 ≤0.3 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]•[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. Clintrials.gov # NCT01209169 (Sapphire) and NCT01846884 (Opal).
AbstractList	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.BACKGROUNDAcute 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.METHODSWe 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 ≤0.3 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 ≤0.3 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%.RESULTSOne 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 ≤0.3 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 ≤0.3 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]•[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.CONCLUSIONSUrinary [TIMP-2]•[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.Clintrials.gov # NCT01209169 (Sapphire) and NCT01846884 (Opal).CLINICAL TRIALS REGISTRATIONClintrials.gov # NCT01209169 (Sapphire) and NCT01846884 (Opal). 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 ≤0.3 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 ≤0.3 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]•[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. Clintrials.gov # NCT01209169 (Sapphire) and NCT01846884 (Opal).
Author	Joannidis, Michael Walker, Michael G Shaw, Andrew D Shi, Jing Feldkamp, Thorsten McCullough, Peter A Kellum, John A Hoste, Eric A J McCarthy, Paul Kashani, Kianoush Uettwiller-Geiger, Denise L Chawla, Lakhmir S
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PublicationTitleAlternate	Nephrol Dial Transplant
PublicationYear	2014
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References_xml	– reference: 23727171 - Lancet. 2013 Jul 13;382(9887):170-9 – reference: 19384211 - Crit Care Med. 2009 Jun;37(6):2079-90 – reference: 10354291 - Kidney Int. 1999 Jun;55(6):2423-32 – reference: 12124404 - N Engl J Med. 2002 Jul 18;347(3):161-7 – reference: 12507953 - Clin Chem. 2003 Jan;49(1):1-6 – reference: 19398670 - Circulation. 2009 May 12;119(18):2444-53 – reference: 21414208 - BMC Bioinformatics. 2011;12:77 – reference: 20194879 - Circulation. 2010 Mar 16;121(10):1227-34 – reference: 20042998 - Kidney Int. 2010 Mar;77(6):536-42 – reference: 22442182 - Clin J Am Soc Nephrol. 2012 May;7(5):844-50 – reference: 21431839 - Eur J Epidemiol. 2011 Apr;26(4):261-4 – reference: 17569110 - Stat Med. 2008 Jan 30;27(2):157-72; discussion 207-12 – reference: 21195518 - Am J Kidney Dis. 2011 Feb;57(2):228-34 – reference: 24856027 - Lancet. 2014 May 24;383(9931):1814-23 – reference: 22738085 - N Engl J Med. 2012 Jul 12;367(2):124-34 – reference: 22203537 - JAMA. 2011 Dec 28;306(24):2684-93 – reference: 19547955 - Intensive Care Med. 2009 Oct;35(10):1692-702 – reference: 23940245 - Pediatrics. 2013 Sep;132(3):e756-67 – reference: 19387314 - Ann Surg. 2009 May;249(5):851-8 – reference: 22067631 - Crit Care Med. 2012 Apr;40(4):1164-70 – reference: 24559465 - Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9 – reference: 22617274 - Lancet. 2012 Aug 25;380(9843):756-66 – reference: 3203132 - Biometrics. 1988 Sep;44(3):837-45 – reference: 16696865 - Crit Care. 2006;10(3):R73 – reference: 23689655 - Contrib Nephrol. 2013;182:45-64 – reference: 23388612 - Crit Care. 2013;17(1):R25 – reference: 20032961 - Kidney Int. 2010 Mar;77(6):527-35
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Snippet	Acute kidney injury (AKI) remains a deadly condition. Tissue inhibitor of metalloproteinases (TIMP)-2 and insulin-like growth factor binding protein (IGFBP)7...
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SubjectTerms	Acute Kidney Injury - pathology Acute Kidney Injury - urine Aged Biomarkers - urine Cell Cycle Checkpoints - physiology Female Follow-Up Studies Humans Insulin-Like Growth Factor Binding Proteins - urine Male Middle Aged Predictive Value of Tests ROC Curve Tissue Inhibitor of Metalloproteinase-2 - urine
Title	Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers
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