BMC Research Notes | |
Implications of the impact of prevalence on test thresholds and outcomes: lessons from tuberculosis | |
Theodore G Ganiats3  Antonino Catanzaro2  Tanya GK Bentley1  | |
[1] Director, Health Economics and Outcomes Research, Partnership for Health Analytic Research, LLC, 280 S Beverly Drive #404, Beverly Hills, CA 90212-3904, USA;Professor, University of California San Diego, Department of Medicine, 9500 Gilman Drive #0643, La Jolla, CA 92093-0643, USA;Executive Director, University of California San Diego, Health Services Research Center, 9500 Gilman Drive #0622, La Jolla, CA 92093-0622, USA | |
关键词: Outcomes; Tuberculosis; Specificity; Sensitivity; Test thresholds; Screening; Testing; Disease prevalence; | |
Others : 1165478 DOI : 10.1186/1756-0500-5-563 |
|
received in 2012-04-25, accepted in 2012-09-18, 发布年份 2012 | |
【 摘 要 】
Background
With today’s rapid advances in technology and understanding of disease, more screening and diagnostic tests have become available in a variety of sociodemographic and clinical settings. This analysis quantifies the impact of varying prevalence rates on test performance for given sensitivity and specificity values.
Methods
Using a worked example of latent tuberculosis infection, we compared true-positive (TP) and false-positive (FP) results when varying prevalence and test sensitivity and specificity. We used estimates from published literature to estimate two tests’ sensitivity (81%, QuantiFERON®-TB Gold In-Tube; 88%, T-SPOT®.TB) and specificity (99%; 88%), and we used World Health Organization data to estimate disease prevalence in five countries.
Results
Varying sensitivity impacted outcomes most in high-prevalence settings; change in specificity had greater impact in low-prevalence settings. In switching from QuantiFERON-TB to T-SPOT.TB (higher sensitivity, lower specificity), trade-offs between increasing case identification (TPs) and decreasing unnecessary treatments (FPs) varied dramatically with prevalence. Lower-prevalence settings paid a greater “price” of more FPs for each TP gained, with 37.7 FPs per TP in the United States (5% prevalence) versus 2.5 in the Ivory Coast (55% prevalence).
Conclusions
Prevalence affects test performance for given sensitivity and specificity values. To optimize test performance, disease prevalence should be incorporated in testing decisions, and sensitivity and specificity should be set locally, not globally. In lower-prevalence settings, using highly specific assays may optimize outcomes.
【 授权许可】
2012 Bentley et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20150416031154616.pdf | 344KB | download | |
Figure 4. | 11KB | Image | download |
【 图 表 】
Figure 4.
【 参考文献 】
- [1]Hunink M, Glasziou P, Siegel J, Weeks J, Pliskin J, Elstein A, Weinstein MC: Decision Making in Health and Medicine: Integrating Evidence and Values. New York: Cambridge University Press; 2001.
- [2]Sox HC, Blatt MA, Higgins MC, Marton KI: Medical Decision Making. Philadelphia: ACP Press; 2007.
- [3]Corbett EL, Watt CJ, Walker N, Maher D, Williams BG, Raviglione MC, Dye C: The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med 2003, 163:1009-1021.
- [4]World Health Organization Stop TB Department: Global TB Database. http://www.who.int/tb/country/global_tb_database/en/index.html?language webcite
- [5]World Health Organization: Tuberculosis Facts. http://www.who.int/entity/tb/publications/2008/factsheet_april08.pdf webcite
- [6]Brosch R, Vincent V: Cutting-edge science and the future of tuberculosis control. Bull World Health Organ 2007, 85:410-412.
- [7]Lam P, LoBue P, Perry S, Catanzaro A: Diagnosis of pulmonary and extrapulmonary tuberculosis. In In Reichman and Hershfield's Tuberculosis: A Comprehensive International Approach. 3rd edition, Part A edition. Edited by Raviglione MC. New York: Informa Healthcare USA, Inc; 2006:155-182.
- [8]Centers for Disease Control and Prevention, Division of Tuberculosis Elimination: Tuberculin Skin Testing Fact Sheet. http://www.cdc.gov/TB/pubs/tbfactsheets/skintesting.htm webcite
- [9]World Health Organization: HIV TB, Guidelines for intensified case finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. http://www.aidsdatahub.org/en/whats-new/287-all-data-alerts/582-who-2010-guidelines-for-intensified-tuberculosis-case-finding-and-isoniazid-preventive-therapy-for-people-living-with-hiv-in-resource-constrained-settings webcite
- [10]Dheda K, Van Zyl Smit R, Badri M, Pai M: T-cell interferon-gamma release assays for the rapid immunodiagnosis of tuberculosis: clinical utility in high-burden vs. low-burden settings. Curr Opin Pulm Med 2009, 15:188-200.
- [11]Ransohoff DR, Feinstein AR: Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med 1978, 299:926-930.
- [12]Cellestis Ltd: QuantiFERON®-TB Gold In-Tube Method [package insert]. http://www.cellestis.com/IRM/Content/info.html webcite
- [13]Oxford Immunotec: International Search Results, T-SPOT®.TB. http://www.oxfordimmunotec.com/Default.aspx?DN=483,108,1,Documents&adxSearchText=package%20insert&start=10&l=English webcite
- [14]Sackett D, Haynes R, Guyatt G, Tugwell P: Clinical epidemiology: a basic science for clinical medicine. 2nd edition. Boston: Little, Brown; 1991.
- [15]Chu H, Nie L, Cole SR, Poole C: Meta-analysis of diagnostic accuracy studies accounting for disease prevalence: alternative parameterizations and model selection. Stat Med 2009, 28:2384-2399.
- [16]Leeflang MM, Bossuyt PM, Irwig L: Diagnostic test accuracy may vary with prevalence: implications for evidence-based diagnosis. J Clin Epidemiol 2009, 62:5-12.
- [17]Willis BH: Empirical evidence that disease prevalence may affect the performance of diagnostic tests with an implicit threshold: a cross-sectional study. BMJ Open 2012, 2:e000746.
- [18]Kemp JR, Mann G, Simwaka BN, Salaniponi FM, Squire SB: Can Malawi’s poor afford free tuberculosis services? Patient and household costs associated with a tuberculosis diagnosis in Lilongwe. Bull World Health Organ 2007, 85:580-585.
- [19]Diel R, Loddenkemper R, Nienhaus A: Evidence-based comparison of commercial interferon-gamma release assays for detecting active TB: a metaanalysis. Chest 2010, 137:952-968.
- [20]U.S. Department of Health & Human Services: U.S. Food and Drug Administration Summary of Safety and Effectiveness. http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070006b.pdf webcite