Skip to main content
. Author manuscript; available in PMC: 2022 Sep 6.
Published in final edited form as: Clin Trials. 2019 Nov 6;17(1):39–51. doi: 10.1177/1740774519885380

Table 2.

Characteristics of patients screened: not enrolled by site choice or patient choice.

Total Total Enrolled lneligible Not enrolled




By site choice By patient choice


No. (Col %) 7452 No. (Row %) 3868 (51.9) No. (Row %) 1469 (19.7) No. (Row %) (Col %) 358 (4.8) OR (95% Cl) − (−) No. (Row %) (Col %) 1757 (23.6) OR (95% Cl) − (−)

Sex
 Male 4046 (54.3) 2119 (52.4) 791 (19.6) 225 (5.6) (62.8) 1.0 (−) 911 (22.5) (51.8) 1.0 (−)
 Female 3406 (45.7) 1749 (51.4) 678 (19.9) 133 (3.9) (37.2) 0.72 (0.57–0.90)b 846 (24.8) (48.2) 1.13 ( 1.01–1.26)b
Age group (years)a
 2–17 757 (10.2) 480 (63.4) 101 (13.3) 29 (3.8) (8.1) 1.0 (−) 147 (19.4) (8.4) 1.0 (−)
 18–35 2878 (38.6) 1567 (54.4) 492 (17.1) 140 (4.9) (39.1) 1.48 (0.98–2.23) 679 (23.6) (38.6) 1.42(1.15–1.74)b
 ≥36 3816 (51.2) 1821 (47.7) 876 (23.0) 189 (5.0) (52.8) 1.72 (I.l5–2.57)b 930 (24.4) (52.9) 1.67 ( 1.36–2.04)b
 Unknown 1 (0) − (−) − (−) − (−) (−) − (−) 1 (100) (0.1) − (−)
Birthplacec
 Canada and United States 2368 (31.8) 1391 (58.7) 383 (16.2) 125 (5.3) (34.9) 1.0 (−) 469 (19.8) (26.7) 1.0 (−)
 Africa 261 (3.5) 104 (39.8) 50 (19.2) 10 (3.8) (2.8) 1.07 (0.55–2.10) 97 (37.2) (5.5) 2.77 (2.06–3.72)b
 Americas—other 2824 (37.9) 1758 (62.3) 358 (12.7) 120 (4.2) (33.5) 0.76 (0.59–0.99)b 588 (20.8) (33.5) 0.99 (0.86–1.14)
 Eastern Mediterranean 153 (2.1) 66 (43.1) 27 (17.6) 29 (19.0) (8.1) 4.89 (3.05–7.85)b 31 (20.3) (1.8) 1.39 (0.9–2.16)
 Europe 282 (3.8) 151 (53.5) 56 (19.9) 8 (2.8) (2.2) 0.59 (0.28–1.23) 67 (23.8) (3.8) 1.32 (0.97–1.79)
 South-East Asia 207 (2.8) 92 (44.4) 41 (19.8) 7 (3.4) (2.0) 0.85 (0.38–1.87) 67 (32.4) (3.8) 2.16 (1.55–3.01)b
 Western Pacific 1008 (13.5) 303 (30.1) 418 (41.5) 34 (3.4) (9.5) 1.25 (0.84–1.86) 253 (25.1) (14.4) 2.48 (2.03–3.02)b
 Non-WHO region 3 (0) 2 (66.7) − (−) − (−) (−) − (−) 1 (33.3) (0.1) − (−)
 Unknown 346 (4.6) 1 (0.3) 136 (39.3) 25 (7.2) (7.0) − (−) 184 (53.2) (10.5) − (−)
Screening countryd
 United States 621 1 (83.3) 3164 (50.9) 1324 (21.3) 304 (4.9) (84.9) 1.0 (−) 1419 (22.8) (80.8) 1.0 (−)
 Brazil 546 (7.3) 403 (73.8) 24 (4.4) 8 (1.5) (2.2) 0.21 (0.1–0.42)b 111 (20.3) (6.3) 0.61 (0.49–0.77)b
 Canada 420 (5.6) 119 (28.3) 87 (20.7) 15 (3.6) (4.2) 1.31 (0.76–2.27) 199 (47.4) (11.3) 3.73 (2.95–4.72)b
 Spain 275 (3.7) 182 (66.2) 34 (12.4) 31 (11.3) (8.7) 1.77 ( 1.19–2.64)b 28 (10.2) (1.6) 0.34 (0.23–0.51)b
Racee
 White 3938 (52.8) 2418 (61.4) 545 (13.8) 177 (4.5) (49.4) 1.0 (−) 798 (20.3) (45.4) 1.0 (−)
 American Indian/Alaska Native 33 (0.4) 14 (42.4) 6 (18.2) 6 (18.2) (1.7) 5.86 (2.22– 15.43)b 7 (21.2) (0.4) 1.52 (0.61–3.77)
 Asian/Pacific Islander 1357 (18.2) 443 (32.6) 503 (37.1) 55 (4.1) ( 15.4) 1.70 ( 1.23–2.33)b 356 (26.2) (20.3) 2.44 (2.07–2.86)b
 Black 1660 (22.3) 878 (52.9) 280 (16.9) 87 (5.2) (24.3) 1.35 ( 1.04– 1.77)b 415 (25.0) (23.6) 1.43 (1.24–1,65)b
 Other 124 (1.7) 98 (79.0) 14 (11.3) 3 (2–4) (0.8) –(−) 9 (7.3) (0.5) –(−)
 Unknown 340 (4.6) 17 (5.0) 121 (35.6) 30 (8.8) (8.4) –(−) 172 (50.6) (9.8) –(−)
Ethnicityf
 Hispanic 2732 (36.7) 1648 (60.3) 368 (13.5) 130 (4.8) (36.3) 1.0 (−) 586 (21.4) (33.4) 1.o(−)
 Non-Hispanic 3602 (48.3) 1635 (45.4) 930 (25.8) 173 (4.8) (48.3) 1.34 (1.06–l.70)b 864 (24.0) (49.2) 1.49 (1.31–1.68)b
 Non-US/Canadian 821 (11.0) 585 (71.3) 58 (7.1) 39 (4.8) (10.9) –(−) 139 (16.9) (7.9) –(−)
 Unknown 297 (4.0) –(−) 113 (38.0) 16 (5.4) (4.5) –(−) 168 (56.6) (9.6) –(−)
Indications for LTBI treatmentg
 Contact 4717 (63.3) 2602 (55.2) 710 (15.1) 195 (4.1) (54.5) 1.0 (−) 1210 (25.7) (68.9) 1.0 (−)
 Contact and TST converter 342 (4.6) 239 (69.9) 29 (8.5) 18 (5.3) (5.0) 1.01 (0.61–1.66) 56 (16.4) (3.2) 0.50 (0.37–0.68)
 TST converter 1861 (25.0) 855 (45.9) 458 (24.6) 122 (6.6) (34.1) 1.90 ( 1.5–2.42)b 426 (22.9) (24.2) 1.07 (0.94–1.23)
 Fibrosis 333 (4.5) 74 (22.2) 206 (61.9) 10 (3.0) (2.8) 1.80 (0.92–3.55) 43 (12.9) (2.4) 1.25 (0.85–1.83)
 HIV-positive 150 (2.0) 80 (53.3) 42 (28.0) 12 (8.0) (3.4) 2.00 ( 1.07–3.74)b 16 (10.7) (0.9) 0.43 (0.25–0.74)

Birthplace: Americas-other (Americas, not Canada or the United States); Cl: confidence interval; fibrosis: fibrosis on chest radiograph; HIV: human immunodeficiency virus; LTBI: latent tuberculosis infection; LTBI treatment indications—contact: contact with infectious tuberculosis case; contact and TST converter: contact with infectious tuberculosis case and TST converter; OR: odds ratio; TST: tuberculin skin test; WHO: World Health Organization.

a

Age group: “Unknown” (total, n = I; not enrolled, n = I): among those not enrolled and not included in univariate analysis.

b

logistic regression and Wald chi-square tests were used to generate ORs and 95% CIs, compared not enrolled categories with enrolled. All overall P-values (not shown) for variables were significant except for “Sex: Total”; significant variable categories are indicated with footnoteb.

c

Birthplace: “Non-WHO Region” (total, n = 3; not enrolled, n = I) and “Unknown” include not reported (total, n = 346; not enrolled, n = 345): not included in univariate analysis.

d

Screening country: one site only in Canada enrolled (n = 6) and did not provide information about patients who were screened but not enrolled.

e

Race: “Other” includes multiracial (total, n = 124, not enrolled, n = 26), and “Unknown” includes not reported (total, n = 340; not enrolled, n = 323): not included in univariate analysis.

f

Ethnicity: for the main PREVENT TB (Sterling et al.3), ethnicity was evaluated only among patients screened in the United States and Canada. “Unknown” includes not reported (total, n = 297; not enrolled, n = 297): not included in univariate analysis.

g

indications for LTBI treatment: participants who had other combinations of risk factors (n = 49); not shown because of limited numbers.