Using Cost and Health Impacts to Prioritize the Targeted Testing of Tuberculosis in the United States

Using Cost and Health Impacts to Prioritize the Targeted Testing of Tuberculosis in the United States

Using Cost and Health Impacts to Prioritize the Targeted Testing of Tuberculosis in the United States THADDEUS L. MILLER, MPH, PETER HILSENRATH, PHD, ...

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Using Cost and Health Impacts to Prioritize the Targeted Testing of Tuberculosis in the United States THADDEUS L. MILLER, MPH, PETER HILSENRATH, PHD, KRISTINE LYKENS, PHD, SCOTT J.N. MCNABB, PHD, PATRICK K. MOONAN, DRPH, AND STEPHEN E. WEIS, DO

PURPOSE: Evaluation improves efficiency and effectiveness. Current U.S. tuberculosis (TB) control policies emphasize the treatment of latent TB infection (LTBI). However, this policy, if not targeted, may be inefficient. We determined the efficiency of a state-law mandated TB screening program and a non statelaw mandated one in terms of cost, morbidity, treatment, and disease averted. METHODS: We evaluated two publicly funded metropolitan TB prevention and control programs through retrospective analyses and modeling. Main outcomes measured were TB incidence and prevalence, TB cases averted, and cost. RESULTS: A non state-law mandated TB program for homeless persons in Tarrant County screened 4.5 persons to identify one with LTBI and 82 persons to identify one with TB. A state-law mandated TB program for jail inmates screened 109 persons to identify one with LTBI and 3274 persons to identify one with TB. The number of patients with LTBI treated to prevent one TB case was 12.1 and 15.3 for the homeless and jail inmate TB programs, respectively. Treatment of LTBI by the homeless and jail inmate TB screening programs will avert 11.9 and 7.9 TB cases at a cost of $14,350 and $34,761 per TB case, respectively. CONCLUSIONS: Mandated TB screening programs should be risk-based, not population-based. Non mandated targeted testing for TB in congregate settings for the homeless was more efficient than statelaw mandated targeted testing for TB among jailed inmates. Ann Epidemiol 2006;16:305–312. Ó 2006 Elsevier Inc. All rights reserved. KEY WORDS:

Tuberculosis, Prevention, Public Health, Targeted Testing, Health Economics, Evaluation.

INTRODUCTION Health care in the United States is in crisis (1). Many agree that the current trajectory of health care costs threatens future access to affordable health care. Despite spending a greater proportion of its gross domestic product for health care than other industrialized countries, the US health care system underperforms when measured by important health impacts (e.g., decreased infant mortality or increased life expectancy). Improving the efficiency of health spending, especially ensuring that benefits justify costs, is a key to resolving this crisis. However, strategies to identify the best use of limited resources remain controversial (2). One strategy is to perform cost-effectiveness analysis (CEA) from a societal perspective (3). Systematic use of CEA to determine From the Department of Medicine, University of North Texas Health Science Center at Fort Worth, Fort Worth, TX (T.L.M., P.H., K.L., P.K.M., S.E.W); School of Public Health, Fort Worth, TX (T.L.M., P.H., K.L., P.K.M., S.E.W); Centers for Disease Control and Prevention, Atlanta, GA (S.J.N.M); and Tarrant County Health Department, Fort Worth, TX (S.E.W.). Address correspondence to: Stephen E. Weis, DO, Department of Medicine, University of North Texas Health Science Center at Fort Worth, 3500 Camp Bowie Blvd, Fort Worth, TX 76107. Tel.: (817) 321-4937; fax: (817) 321-4920. E-mail: [email protected]. Received April 3, 2005; accepted July 5, 2005. Ó 2006 Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010

insurance coverage decisions is an elusive goal (4). However, informed decision making does not always require a full CEA. Even in the context of disease elimination, such as tuberculosis (TB) prevention and control in the United States, public health programs should determine practical strategies to provide the most efficient prevention and control impacts. TB remains a public health problem in the United States despite historically low prevalence. In 2004, the United States had 14,511 new reported TB cases, an all-time low (5, 6). This trend caused the Centers for Disease Control and Prevention (CDC) to reevaluate the US TB elimination strategy and recommend targeted testing of specific high-risk populations (Table 1) (7, 8). Identifying and treating persons with latent TB infection (LTBI) is important to this strategy. Additionally, the Institute of Medicine recommended the development of more effective methods for identifying and treating persons with LTBI, but do not provide guidelines on how best to do so (14). Experts generally accept that homeless and jailed persons in the United States are at increased risk for infection with TB (15–25). Many recommendations identify these population groups for TB prevention and control efforts to decrease ongoing TB transmission (21–25). These recommendations target test those most likely to benefit from and comply with treatment recommendations (24, 25). However, mandated 1047-2797/06/$–see front matter doi:10.1016/j.annepidem.2005.07.053

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Selected Abbreviations and Acronyms CEA Z cost-effectiveness analysis TB Z tuberculosis LTBI Z latent tuberculosis infection CDC Z Centers for Disease Control and Prevention TST Z tuberculin skin test TCPHD Z Tarrant County Public Health Department RIF/PZA Z rifampin/pyranazimide

TB targeted testing in specific populations varies across jurisdictions and may not reflect efficient practices. When targeted-testing strategies must be prioritized, their relative cost efficiencies should be considered. In Texas, active TB case-finding is a state-law–mandated program for inmates in jails with population sizes greater than 100 (26). Although this law does not mandate screening for or treatment of LTBI, this intervention does further TB prevention and control goals and is performed routinely in Tarrant County jails (27, 28). However, there are fewer data to guide strategies for TB prevention and control programs in jails than prisons or congregate living facilities for the homeless (19, 21). Nevertheless, TB outbreaks in jails capture public attention and require clearly articulated data-driven strategies (27–36). We compared costs and health impacts between two TB programs in Tarrant County: the correctional health TB surveillance program and a homeless shelter outreach program. We focus on the health impacts of each program designed to identify and treat LTBI. One additional outcome of this study is an economic tool that can be used to evaluate various strategies for TB prevention and control.

METHODS We conducted a retrospective comparison of the cost and health impacts between the Tarrant County, TX, homeless TB screening program and the jail TB screening program. This evaluation was part of the Tuberculosis Epidemiologic Studies Consortium Project, New Model for Assessing

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Tuberculosis Surveillance and Action Performance and Cost, funded by the CDC. The unit of study was the public health program; no individual patient information was used. The study period for the jail program was 335 days from December 19, 2001, through December 18, 2002. Data used for analysis of the homeless program were collected for calendar year 2003. Comparisons are made based on patients with TB diagnosed in the study period and having known treatment duration. Treatment durations reflect all treatment, including that known to occur in other settings. Reports from all TB screening programs in county jail facilities in Tarrant County were included in this evaluation. In Tarrant County, jail inmates are administered a Mantoux tuberculin skin test (TST) with 5 tuberculin unit–strength purified protein derivative. Those with a clearly documented prior positive TST result are not retested. A TST reading of 10 mm or greater induration is defined as a positive result. If there is a history of TB exposure or human immunodeficiency virus infection, positive is defined at 5 mm or greater. All individuals with a newly positive TST result, a previous positive TST result, or symptoms of TB-related illness undergo additional evaluation by medical personnel at the facility. Treatment of LTBI is offered as clinically appropriate. Medically licensed staff directly observed all TB therapy. Jail program data were abstracted from monthly reports compiled by Tarrant County Public Health Department (TCPHD) personnel. These reports included number of evaluations, TST results, radiographs, cultures, diagnosis, and TB risk information (e.g., TST converter, human immunodeficiency virus status, regimen and amount of TB treatment, and final status). We gathered population information from the US Census Bureau (37). The homeless program is an outreach effort by the TCPHD in which homeless persons in a congregate setting are targeted for TB testing. The program includes on-site TB symptom check, chest radiograph, TST, and medical evaluation. TST was performed as described. Area residents had TB exposure, and a positive TST result was defined as 5 mm or greater. TCPHD personnel, who were available

TABLE 1. Comparison of populations at risk for tuberculosis, United States and Tarrant County, Texas, 2002 (6, 7, 9–13) United States Variable Total Homelessa Foreign-born Local jailb a

Population (%) 280,540,330 800,000–3,500,000 (0.3%–1.3%) 32,453,000 (11.6%) 652,082 (0.2%)

No. of cases reported

Tarrant County, Texas Incidence rate (/100,000 population)

Population (%)

No. of cases reported

Incidence rate (/100,000 population)

5.2 110.3–25.2 23.1 Unknown

1,446,219 4,375–8,631 (0.3%–0.6%) 206,061 (14.3%) 3119 (0.2%)

109 13 53 7

7.2 297.1–150.6 26 31c

15,075 883 7659 Unknown

Range is point estimate of the number of homeless at any time in 1 year. Average daily population in 2002. Tuberculosis incidence rate based on number screened.

b c

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for 5 evening hours Monday through Friday, observed treatment on site. Personnel observing TB therapy were experienced in working with homeless persons and successfully completed the CDC core TB training modules, but did not have medical licenses (38). Training included TB symptoms, side effects, directly observed preventive therapy, follow-up, tracking protocols, and safety strategies. In addition, personnel were supervised by public health nurses and physicians. Patients received an incentive for keeping medication appointments, including dietary supplements or fast-food coupons. Resumption of TB therapy for interruptions of less than 3 months did not require reevaluation. No costs accrued to the homeless shelter or patients (39). Costs and activities associated with the detection and treatment of TB in these two settings were estimated as previously described for patients with uncomplicated active TB and LTBI (40). They were adjusted to reflect current conditions and TB treatment recommendations (41–45). Treatment and professional costs were estimated at the midpoint of Medicare’s national average allowance and mean fee for non-Medicare charges, and average wholesale price for drugs was used (40). Costs were adjusted to 2003 US dollars (45). The sums of screening and treatment costs were used for comparison of programs. Costs of negative screening results were adjusted proportionally to the number of LTBI and TB diagnoses made. Estimated hospitalization rates and costs were adjusted to the region (46). We did not consider costs for contact investigations, patient expenses, facilities, administration, or other program costs. Treatment regimens for LTBI were described according to medications used, dosing, and proportion of a full course of treatment completed. We categorized treatment of LTBI as either isoniazid therapy (‘‘long course’’) or other drug combination (‘‘short course’’). Costs and disease risk

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reduction associated with LTBI treatment reflected the duration of treatment (47–57). Therapy was observed, so we assumed ‘‘completer-complier’’ efficacy and cumulative effect for multiple sessions or regimens of LTBI treatment (58). Dosing and duration information were converted to a standard metric reflecting the proportion of recommended treatment for each regimen. We modeled risk reduction from LTBI treatment as a cumulative reduction of disease risk for risk groups from the annual expected risk (47–57). Within the model, recent converters remained at increased risk for 1 year, then their risk decreased to that of remotely infected (47–57). Navigate to http://www.hsc.unt.edu/ intmed/Documents/risk%20reduction%20calculator.xls to access our disease reduction estimation tool. Differences in proportions, medians, and means were calculated. All statistical tests were two sided, with levels of 0.05 or less considered significant. Descriptive statistics were compiled and calculations were performed using Microsoft Excel 2002 (Microsoft Corp., Redmond, WA), SPSS, version 12 (SPSS Inc., Chicago, IL), and STATA 8.0 (StataCorp LP, College Station, TX).

RESULTS During 335 days in 2002, a total of 22,920 jailed inmates underwent state-law–mandated TB screening in the Tarrant County jail system (Table 2). The result of this targeted testing was identification of 14 TB suspects, TB subsequently was diagnosed in seven of these patients, and 211 patients were prescribed treatment for LTBI. A second non– state-law–mandated TB program screened homeless persons in Tarrant County. In this program, 822 homeless persons were screened and 34 TB suspects were identified, TB

TABLE 2. Comparison of the yield of TB infected and diseased patients, by screening program, Tarrant County, Texas, 2002 No. of patients (%)

Screened TST placed Previous positive result Positive TST resultb Treatment for LTBI prescribedc Treated for TB Lost unread No. screened/LTBI No. screened/TB case Screenings/treatmentd

Cost, 2003 (US $)a

per 100,000

Homeless

Jail

p

Homeless

Jail

Homeless

Jail

822 778 (94.7) 63 (7.7) 127 (15.5) 181 (22) 10 (1.2) 245 (29.8) 4.5 82.2 5.7

22,920 21,778 (95) 1142 (5) 303 (2) 211 (0.9) 7 (0.03) 6760 (31.1) 108.7 3274 140

0.179 0.001 !0.001 !0.001 !0.001 0.356 d d d

d d 7664 15,456 22,019 1217 29,817 22,222 1217 d

d d 4983 1322 951 31 29,568 920 31 d

$54,334 d d d $809 $7835 d $300 $5433 $377

$245,244 d d d $774 $7835 d $1163 $35,035 $1498

LTBI, latent tuberculosis infection; TB, tuberculosis; TST, tuberculin skin test. a Cost reflects average cost per treatment, per patient; cost per number screened reflects screening costs required to yield one LTBI or TB diagnosis. Treatment criteria include exposure, symptoms, or other factors not limited to positive screening. b Proportion of tests that were read. c Diagnosis of LTBI may be caused by factors other than positive TST (e.g., exposure, previous positive TST result with inadequate treatment). Number of LTBIs includes 24 homeless program suspects and 7 jail program suspects in whom TB was ruled out. d Number and cost of screenings required to initiate one treatment.

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subsequently was diagnosed in 10 of these patients, and 181 patients were prescribed treatment for LTBI. TB suspects not confirmed as having TB were treated for LTBI. An estimate of the resources required to avert one TB case through screening and treatment of LTBI is a function of the number necessary to screen to detect and treat patients with LTBI and duration of treatment (Table 3). In the homeless program, 69 screenings were required to avert one TB case, 5.7 screenings were needed to initiate one LTBI treatment, and 12.1 treatments were required to avert one case. The jail program found fewer TB cases and required more treatments per TB case averted, resulting in 2142 screenings to avert one TB case. The homeless person TB program cost $14,350 per TB case prevented, and the jail inmate TB program cost $34,761 per TB case prevented. The larger estimated risk reduction achieved by treatment of LTBI in the homeless person TB program will result in 150% more TB averted than will the jail inmate TB program (11.9 versus 7.9 TB cases averted, respectively). LTBI treatments given within the homeless program yielded greater overall levels of completion than the jail program (median homeless program treatment completed Z 0.72 treatment course [midspread Z 0.31 to 1] versus median jail program treatment completed Z 0.26 treatment course [midspread Z 0.06 to 0.89]). Every 12.1 treatments of LTBI initiated in the homeless program and 15.3 treatments

TABLE 3. Outcomes of treatment for LTBI in the homeless and jail screening programs, Tarrant County, Texas, 2002 to 2003 Homeless

Jaila

No. of patients (%)

No. of patients (%)

Treatment for LTBI prescribed 181 Total treated 143 Refused or lost 38 (26.6) Short course 77 (42.5) Long course 66 (36.5) 0.72 (0.31–1) Median treatment completed (midspread)b TB cases preventedc 11.9 Average cost for LTBI treatment 809 (2003 US $)d No. of LTBI treatments 12.1 to prevent 1 TB case Screenings to prevent 1 TB case 69 Screening cost per case preventede ($) 4561 Cost per case preventede ($) 14,350

211 121 47 (22.3) 39 (32.2) 82 (67.8) 0.26 (0.06–0.89) 7.9 774 15.3 2,142 22,919 34,761

TB, tuberculosis; LTBI, latent tuberculosis infection. a Excludes those with unknown treatment durations (w20%). b Median of recommended therapy, short and long course combined in full course equivalents. c From risk reduction during 20 years. d Cost for average proportion completed adjusted to reflect treatment regimen. e Total cost to detect and treat sufficient LTBI to prevent one case and excludes 43 cases with duration unknown in jail cohort.

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initiated in the jail program resulted in a sufficient risk reduction to prevent one patient from developing TB. Estimated individual screening and treatment costs were slightly greater in the homeless population, largely because of the use of a chest radiograph added to the TST for every patient at the initial screening. The cost per patient diagnosed was much greater in the jail program than the homeless program (TB Z $35,035 versus $5433 and LTBI Z $1163 versus $300, respectively). There were no differences in outcomes or estimated treatment costs for patients with TB in the jail and homeless programs. In both, standard treatment regimens were prescribed, and all completed therapy. We predict that LTBI treatment in the homeless population achieved 74% of the current maximum possible disease reduction, considering its risk groups (Table 4). The jail inmate population achieved 52% of the maximum possible disease reduction. When LTBI incidence is decreased by 50% and 75% in sensitivity analyses, we estimate minimum costs per active case averted range from $21,082 to $71,514 if all treatment is completed and $28,943 to $137,306 with treatment completed as found. Within the jail, 6760 persons did not have their TST read because of release. Our findings suggest that had a test been available to more rapidly diagnose TB, and additional two TB cases and 62 latent or suspected TB infections would have been discovered. A similar proportion of TSTs were not read among homeless persons. We predict that another three TB cases and 56 latent or suspected TB infections would have been discovered if all TSTs were read.

DISCUSSION Using data routinely accessible by local health agencies, we found that a homeless TB screening program was more than 21 times more effective in identifying LTBI and almost 40 times more effective in detecting TB than a state-law–mandated jail TB screening program. The homeless program averted more cases of TB at less cost. These results show that mandated TB screening should be justified on population risk. Determining population risk does not require extensive research, but often can be done by using sampling or preexisting data. Risk-based TB screening programs that include congregate living facilities for homeless persons should be highly effective in averting TB disease. Both targeted screening programs detected much greater morbidity than if unrestricted broad-population screening were used. In addition, our data provide validation to guidelines recommending targeted testing for TB.

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TABLE 4. Sensitivity analysis showing benefits and cost per TB case averted when the diagnosis of LTBI is made, Tarrant County, Texas, 2002 to 2003 LTBI diagnosis made Homeless, n Z 143 Jail, n Z 121 Homeless, n Z 72 Jail, n Z 61 Homeless, n Z 36 Jail, n Z 30

Maximum benefita

Actual benefitb

When LTBI is as found 16.2 11.9 15.2 7.9 When LTBI is decreased 50% 8.1 5.9 7.6 4 When LTBI is decreased 75% 3.9 3 3.8 2

LTBI incidence (/100,000 population)

Cost per TB case avertedc (2003 US $)

2202 92

With maximum benefit 10,541 18,067

Actual 14,350 34,761

1101 46

21,082 36,133

28,943 68,653

551 23

43,786 71,514

56,922 137,306

Total actual cost (2003 US $)d 170,765 274,613

LTBI, latent tuberculosis infection; TB, tuberculosis. a In cases averted over time where risk factors remain constant, maximum benefit implies 100% compliance with recommended treatment. b Actual benefit implies benefit with treatment completion rates as found. Screened persons: 828 homeless screened, 22,920 jail screened. c Cost to detect and treat sufficient LTBI to avert one case. Costs represent screening and treatment for LTBI and TB suspects only. d Excludes cost for 43 inmates with treatment duration unknown.

The growth in the cost of US health care is not sustainable. There is growing recognition that greater efficiency in the health sector will involve tough decisions about priorities, with resource allocation going to the most efficient activities (1–4). These decisions are difficult to make for diseases for which the goal is elimination (14). Decreasing TB infection in the general population makes traditional case-finding increasingly expensive at the margin, requiring new approaches (8, 17, 19–24). Modeling has been used to attempt to identify the best TB control practices (52, 56, 57). We combined these techniques with program data to compare for the first time the relative effectiveness of two TB programs. Homelessness predisposes people with LTBI to progress to TB, and TB in this population has been identified as a major source of morbidity in metropolitan areas across the United States (59–64). Studies of TB isolates from homeless persons detected unsuspected TB transmission across jurisdictional borders and between homeless and nonhomeless persons and found transmission of multidrug-resistant TB (62, 65). Estimates of the national homeless population in the late 1990s varied from 800,000 to 3,500,000 persons (66). Assuming TB morbidity similar to that found in the Tarrant County homeless program, the national homeless population may represent a reservoir of 22,019 patients with LTBI per 100,000 screened. Per 100,000 similar screenings and LTBI treatments, we estimate an investment of $20,806,148 in detection and treatment would identify 1217 persons with TB in the screening year and avert 1449 cases. Likewise, 100,000 jail inmates screened would result in identification of 31 TB cases and avert 47 cases at a cost of $1,633,767. The ultimate cost or savings from such efforts will require study of the full cost of TB, but our findings indicate that achieving the goal of national TB elimination will require innovative programs in homeless and other high-risk populations.

An insight from a study of strategies for TB risk reduction was that access to care is more important to reducing TB and deaths in the homeless than improving effectiveness of therapy (19). The TCPHD homeless program is designed to be maximally accessible. This may contribute to the high acceptance and completion of treatment for LTBI in that program. Seventy-nine percent of homeless patients started LTBI therapy, and the median proportion of LTBI therapy completed was 72%. In a study of 4 years of LTBI treatment in homeless persons in Denver, only 21% with LTBI were started on therapy and only 28% of those completed therapy (69). In an LTBI treatment adherence study, homeless persons randomly assigned to usual care in San Francisco received a median of 2 months of isoniazid therapy, with similar results found in other studies (67–70). An unexpected finding in our study is that the Tarrant County homeless population was more stable in terms of successful therapy than the jail population. Using monitoring and evaluation to measure cost and performance in TB control programs has been described previously (71). That analysis identified wasted resources and missed opportunities for TB control within a county jail system (71). Our study describes how monitoring and evaluation can suggest more efficient use of resources among many choices for public health action. At midyear 2003, there were 691,301 jailed inmates held nationally, and that number is increasing (72). Turnover is high, with jail inmates usually confined a year or less (72). Although there are few data on results of TB screening in jails, there is evidence of TB transmission within jails and from jails into the community (15, 16, 27–35, 72–74). It was suggested that TB testing of jail inmates has a major role in reducing TB in the community (30). In the Tarrant County jail program, we found a TB prevalence of 31 cases per 100,000 and an LTBI prevalence of 921 cases per

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100,000. This emphasizes the importance of the jail as a reservoir of TB and a location where targeted testing and treatment of TB can occur, but inmate turnover and treatment follow-up challenges remain. We recognize that we do not include all costs associated with TB, including those generated by contact investigations, secondary transmission, and patient costs (50, 51, 58, 75). All such costs are assumed to be similar in this study. We therefore underestimated the complete cost of a TB case by failing to consider these additional costs and hence underestimated the full savings from averting a case of TB (50, 75). Some differences exist between the jail inmate and homeless person cohorts that may affect comparability. Existing programmatic data were collected, allowing only gross demographic comparisons of the groups. The study periods were not concurrent. During the time the jail program was analyzed, rifampin/pyranazimide (RIF/PZA) therapy was not known to carry undue risk and was recommended as appropriate for short-duration LTBI therapy (76). During the period the homeless program was analyzed, RIF/PZA therapy rarely was used because of potential side effects. However, these differences do not affect our conclusions because the RIF/PZA combination therapy has been shown to increase treatment completion compared with isoniazid therapy. Lack of complete information on dosing resulted in approximately 20% of jail LTBI treatments being excluded from analysis; however, these missing data were random, with no indication that this information would change our findings. TB screening is recommended in many situations by guidelines and mandated in some by legal statute (15–26). Decisions about populations required to undergo TB screenings are made at a political level for many reasons. The protection of public health and protection of prisoners from exposure to potentially fatal preventable illnesses often must be considered before questions of efficiency. Wide variations in TB risks and public health infrastructures make it difficult to generalize the experience in Tarrant County to the United States, and both inmate and homeless populations offer challenges for TB control that have been well described (8, 9, 14–21, 24, 27–36). Finding relative efficiency in the homeless program in Tarrant County does not require that jail programs be abandoned for homeless programs. Rather, our findings suggest that strategies for TB elimination should ensure efficient use of resources within communities through an evaluation component. We illustrate how monitoring and evaluation can help set priorities to maximize return on spending for TB interventions. By directing prevention and control programs toward reservoirs of latent disease and populations for which risk makes them effective and efficient screening targets, we can improve our progress toward achieving TB elimination in the United States.

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The authors gratefully acknowledge the contributions to this work made by Karen Kardaras, Maureen Wilce, and Bridget Young.

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