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ORIGINAL ARTICLE
Open Access

Diagnostic Utility and Impact on Clinical Decision Making of Focused Assessment With Sonography for HIV-Associated Tuberculosis in Malawi: A Prospective Cohort Study

Daniel Kahn, Kara-Lee Pool, Linna Phiri, Florence Chibwana, Kristin Schwab, Levison Longwe, Ben Allan Banda, Khumbo Gama, Mayamiko Chimombo, Chifundo Chipungu, Jonathan Grotts, Alan Schooley and Risa M. Hoffman
Global Health: Science and Practice March 2020, 8(1):28-37; https://doi.org/10.9745/GHSP-D-19-00251
Daniel Kahn
aDepartment of Internal Medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.
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  • For correspondence: DaKahn@mednet.ucla.edu
Kara-Lee Pool
bDepartment of Radiology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.
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Linna Phiri
cPartners in Hope, Lilongwe, Malawi.
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Florence Chibwana
cPartners in Hope, Lilongwe, Malawi.
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Kristin Schwab
dDepartment of Medicine, Division of Pulmonology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.
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Levison Longwe
cPartners in Hope, Lilongwe, Malawi.
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Ben Allan Banda
cPartners in Hope, Lilongwe, Malawi.
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Khumbo Gama
cPartners in Hope, Lilongwe, Malawi.
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Mayamiko Chimombo
cPartners in Hope, Lilongwe, Malawi.
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Chifundo Chipungu
cPartners in Hope, Lilongwe, Malawi.
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Jonathan Grotts
eDepartment of Medicine Statistics Core, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.
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Alan Schooley
cPartners in Hope, Lilongwe, Malawi.
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Risa M. Hoffman
fDepartment of Medicine, Division of Infectious Disease, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.
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    Images of Findings From Focused Assessment With Sonography of HIV-Associated Tuberculosis Protocol in Participants With Signs and Symptoms of Tuberculosis (a) Anechoic fluid surrounding the heart consistent with a moderate pericardial effusion. (b) Anechoic area superior (left) to the diaphragm and liver consistent with a large right pleural effusion. (c) Isoechoic nodules consistent with peri-portal and para-aortic lymphadenopathy. (d) Color Doppler further differentiates vasculature from lymph nodes.© 2016 Daniel Kahn/UCLA

  • FIGURE 1
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    FIGURE 1

    Participant Enrollment in a Prospective Cohort Study Assessing Diagnostic Utility of FASH at an Urban Medical Center, Lilongwe, Malawi, and Clinicians' Stepwise Diagnostic Evaluation and Decision Making

    Abbreviations: FASH, focused assessment with sonography for HIV-associated tuberculosis; LAM, lipoarabinomannan; MTB, Mycobacterium tuberculosis; RIF, rifampicin; TB, tuberculosis.

    aFinal categorization made by study investigators based on 6-month data and definitions above.

    bIncludes 2 deaths.

    cIncludes 12 deaths: 7 in Subgroup 2 and 5 in Subgroup 3.

  • FIGURE 2
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    FIGURE 2

    Comparison of Clinicians' Decision to Empirically Treat TB in Participants at 2 Time Points at an Urban Medical Center, Lilongwe, Malawi, by TB Categorya

    Abbreviations: FASH, focused assessment with sonography for HIV-associated tuberculosis; H, history; P, physical exam; TB, tuberculosis.

    aTB categories determined by study authors after 6-month follow-up.

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    TABLE 1.

    Baseline Demographic and Clinical Characteristics of Participants at an Urban Medical Center, Lilongwe, Malawi, Stratified by TB Category (N=181)

    Unlikely TB (n=125)Probable/Confirmed TB (n=56)P Value
    Age, years, median (IQR)a40.0 (34.0–45.0)39.0 (33.0–43.0).51
    Gender.42
    Male, No. (%)56.0 (44.8)29.0 (51.7)
    Female, No. (%)69.0 (55.2)27.0 (48.2)
    Baseline CD4 Count (cells/mm3), median (IQR)b256.0 (80.0–484.0)117.0 (29.0–176.0)<.001
    Viral Load (copies/ml)c.21
    <1,000, No. (%)80.0 (64.0)28.0 (50.0)
    1,000–50,000, No. (%)14.0 (11.2)11.0 (19.6)
    >50,000, No. (%)22.0 (17.6)9.0 (16.0)
    Baseline ART Regimend.001
    TDF/3TC/EFV, No. (%)70.0 (56.0)20.0 (35.7)
    Other NNRTI-based regimen, No. (%)17.0 (13.6)2.0 (3.6)
    Protease inhibitor-based regimen, No. (%)12.0 (9.6)3.0 (5.4)
    No ART, No. (%)25.0 (20.0)26.0 (46.4)
    Previous TB,e No. (%)32.0 (25.6)12.0 (21.4).58
    TB Sign/Symptomf
    Fever, No. (%)83.0 (66.4)42.0 (75.0).30
    Cough, No. (%)108.0 (86.4)51.0 (91.1).47
    Night sweats, No. (%)77.0 (61.6)37.0 (66.1).62
    Weight loss, No. (%)98.0 (78.4)50.0 (89.3).10
    BMI, median (IQR)19.2 (17.5–22.9)18.6 (16.7–19.8).01
    • Abbreviations: ART, antiretroviral therapy; BMI, body mass index; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitor; TB, tuberculosis; TDF/3TC/EFZ, tenofovir disoproxil fumarate/lamivudine/efavirenz.

    • ↵a Missing in 5 individuals.

    • ↵b Missing in 4 individuals.

    • ↵c Missing in 17 individuals.

    • ↵d Missing in 6 individuals.

    • ↵e Based on participant self report.

    • ↵f Participants could have 2 or more signs/symptoms based on screening questions at study entry.

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    TABLE 2.

    Baseline FASH Findings in Participants at an Urban Medical Center, Lilongwe, Malawi, Stratified by TB Category (N=181)

    Overall, No. (%) (N=181)Unlikely TB, No. (%) n=125Probable/Confirmed TB, No. (%) n=56P Value
    Pericardial effusiona36 (19.9)12 (9.6)24 (42.9)<.001
    Pleural effusion9 (5.0)1 (0.8)8 (14.3)<.001
    Ascites14 (7.7)5 (4.0)9 (16.1).01
    Abdominal lymphadenopathy15 (8.3)2 (1.6)13 (23.2)<.001
    Liver lesions4 (2.2)3 (2.4)1 (1.8)>.99
    Splenic lesions5 (2.8)2 (1.6)3 (5.4).17
    FASH positiveb70 (38.7)30 (24.0)c40 (71.4)<.001
    FASH negative111 (61.3)95 (76.0)16 (28.6)<.001
    • Abbreviations: FASH, focused assessment with sonography for HIV-associated tuberculosis; TB, tuberculosis.

    • ↵a Trace pericardial effusions were excluded from the analysis due to unclear clinical significance.

    • ↵b Any single finding of the protocol is positive.

    • ↵c Positive FASH for unlikely TB subgroups: (1) low clinical suspicion with improvement=19/111; (2) low clinical suspicion without improvement= 5/8; (3) High clinical suspicion, treated, without improvement=6/6.

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    TABLE 3.

    Associations of FASH Findings With Probable/Confirmed TB in Participants at an Urban Medical Center, Lilongwe, Malawi (N=56)

    VariableOR (95% CI)Sensitivity (95% CI)Specificity (95% CI)PPV (95% CI)NPV (95% CI)PLR (95% CI)NLR (95% CI)
    Pericardial effusiona7.06 (3.18, 15.66)0.43 (0.30, 0.57)0.90 (0.84, 0.95)0.67 (0.49, 0.81)0.78 (0.70, 0.84)4.30 (2.32, 7.97)0.63 (0.50, 0.80)
    Pleural effusion8.91 (2.35, 33.82)0.18 (0.09, 0.30)0.98 (0.93, 1.00)0.77 (0.46, 0.95)0.73 (0.65, 0.79)9.00 (2.58, 31.45)0.84 (0.74, 0.95)
    Ascites4.60 (1.47, 14.44)0.16 (0.08, 0.28)0.96 (0.91, 0.99)0.64 (0.35, 0.87)0.72 (0.64, 0.79)4.00 (1.40, 11.39)0.88 (0.78, 0.99)
    Abdominal lymphadenopathy13.35 (3.66, 48.71)0.25 (0.14, 0.38)0.98 (0.93, 1.00)0.82 (0.57, 0.96)0.74 (0.67, 0.81)12.50 (3.74, 41.80)0.77 (0.66, 0.90)
    Hepatic lesions0.74 (0.08, 7.27)0.02 (0.00, 0.10)0.98 (0.93, 1.00)0.25 (0.01, 0.81)0.69 (0.62, 0.76)1.00 (0.11,9.40)1.00 (0.96, 1.05)
    Splenic lesions3.48 (0.57, 21.43)0.05 (0.01, 0.15)0.98 (0.94, 1.00)0.60 (0.15, 0.95)0.70 (0.63, 0.77)2.50 (0.43, 14.55)0.97 (0.91, 1.04)
    FASH positive7.92 (3.89, 16.12)0.71 (0.58, 0.83)0.76 (0.68, 0.83)0.57 (0.45, 0.69)0.86 (0.78, 0.92)2.96 (2.08, 4.21)0.38 (0.25, 0.58)
    • Abbreviations: CI, confidence interval; FASH, focused assessment with sonography for HIV-associated tuberculosis; NLR, negative likelihood ratio; NPV, negative predictive value; OR, odds ratio; PLR, positive likelihood ratio; PPV, positive predictive value; TB, tuberculosis.

    • ↵a Trace pericardial effusions were excluded from the analysis due to unclear clinical significance.

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Global Health: Science and Practice: 8 (1)
Global Health: Science and Practice
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March 30, 2020
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Diagnostic Utility and Impact on Clinical Decision Making of Focused Assessment With Sonography for HIV-Associated Tuberculosis in Malawi: A Prospective Cohort Study
Daniel Kahn, Kara-Lee Pool, Linna Phiri, Florence Chibwana, Kristin Schwab, Levison Longwe, Ben Allan Banda, Khumbo Gama, Mayamiko Chimombo, Chifundo Chipungu, Jonathan Grotts, Alan Schooley, Risa M. Hoffman
Global Health: Science and Practice Mar 2020, 8 (1) 28-37; DOI: 10.9745/GHSP-D-19-00251

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Diagnostic Utility and Impact on Clinical Decision Making of Focused Assessment With Sonography for HIV-Associated Tuberculosis in Malawi: A Prospective Cohort Study
Daniel Kahn, Kara-Lee Pool, Linna Phiri, Florence Chibwana, Kristin Schwab, Levison Longwe, Ben Allan Banda, Khumbo Gama, Mayamiko Chimombo, Chifundo Chipungu, Jonathan Grotts, Alan Schooley, Risa M. Hoffman
Global Health: Science and Practice Mar 2020, 8 (1) 28-37; DOI: 10.9745/GHSP-D-19-00251
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