PMID- 27296150 OWN - NLM STAT- MEDLINE DCOM- 20170127 LR - 20220331 IS - 1471-2490 (Electronic) IS - 1471-2490 (Linking) VI - 16 IP - 1 DP - 2016 Jun 13 TI - The diagnostic accuracy of urine-based tests for bladder cancer varies greatly by patient. PG - 30 LID - 10.1186/s12894-016-0147-5 [doi] LID - 30 AB - BACKGROUND: Spectrum effects refer to the phenomenon that test performance varies across subgroups of a population. When spectrum effects occur during diagnostic testing for cancer, difficult patient misdiagnoses can occur. Our objective was to evaluate the effect of test indication, age, gender, race, and smoking status on the performance characteristics of two commonly used diagnostic tests for bladder cancer, urine cytology and fluorescence in situ hybridization (FISH). METHODS: We assessed all subjects who underwent cystoscopy, cytology, and FISH at our institution from 2003 to 2012. The standard diagnostic test performance metrics were calculated using marginal models to account for clustered/repeated measures within subjects. We calculated test performance for the overall cohort by test indication as well as by key patient variables: age, gender, race, and smoking status. RESULTS: A total of 4023 cystoscopy-cytology pairs and 1696 FISH-cystoscopy pairs were included in the analysis. In both FISH and cytology, increasing age, male gender, and history of smoking were associated with increased sensitivity and decreased specificity. FISH performance was most impacted by age, with an increase in sensitivity from 17 % at age 40 to 49 % at age 80. The same was true of cytology, with an increase in sensitivity from 50 % at age 40 to 67 % at age 80. Sensitivity of FISH was higher for a previous diagnosis of bladder cancer (46 %) than for hematuria (26 %). Test indication had no impact on the performance of cytology and race had no significant impact on the performance of either test. CONCLUSIONS: The diagnostic performance of urine cytology and FISH vary significantly according to the patient demographic in which they were tested. Hence, the reporting of spectrum effects in diagnostic tests should become part of standard practice. Patient-related factors must contextualize the clinicians' interpretation of test results and their decision-making. FAU - Gopalakrishna, Ajay AU - Gopalakrishna A AD - Division of Urology, Duke University Medical Center, Durham, NC, 27710, USA. FAU - Longo, Thomas A AU - Longo TA AD - Division of Urology, Duke University Medical Center, Durham, NC, 27710, USA. FAU - Fantony, Joseph J AU - Fantony JJ AD - Division of Urology, Duke University Medical Center, Durham, NC, 27710, USA. FAU - Owusu, Richmond AU - Owusu R AD - Department of Urology, University of California San Diego, San Diego, CA, USA. FAU - Foo, Wen-Chi AU - Foo WC AD - Department of Pathology, Duke University Medical Center, Durham, NC, USA. FAU - Dash, Rajesh AU - Dash R AD - Department of Pathology, Duke University Medical Center, Durham, NC, USA. FAU - Inman, Brant A AU - Inman BA AD - Division of Urology, Duke University Medical Center, Durham, NC, 27710, USA. brant.inman@duke.edu. LA - eng GR - TL1 TR001116/TR/NCATS NIH HHS/United States PT - Journal Article DEP - 20160613 PL - England TA - BMC Urol JT - BMC urology JID - 100968571 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Cohort Studies MH - Cystoscopy/trends MH - Female MH - Hematuria/diagnosis/urine MH - Humans MH - Longitudinal Studies MH - Male MH - Middle Aged MH - Retrospective Studies MH - Urinalysis/*standards MH - Urinary Bladder Neoplasms/*diagnosis/surgery/*urine PMC - PMC4906712 OTO - NOTNLM OT - Bladder cancer OT - Cytology OT - FISH OT - Sensitivity OT - Specificity OT - Spectrum effects EDAT- 2016/06/15 06:00 MHDA- 2017/01/28 06:00 PMCR- 2016/06/13 CRDT- 2016/06/15 06:00 PHST- 2015/12/07 00:00 [received] PHST- 2016/06/03 00:00 [accepted] PHST- 2016/06/15 06:00 [entrez] PHST- 2016/06/15 06:00 [pubmed] PHST- 2017/01/28 06:00 [medline] PHST- 2016/06/13 00:00 [pmc-release] AID - 10.1186/s12894-016-0147-5 [pii] AID - 147 [pii] AID - 10.1186/s12894-016-0147-5 [doi] PST - epublish SO - BMC Urol. 2016 Jun 13;16(1):30. doi: 10.1186/s12894-016-0147-5.