Table 7.
Clinical Outcome on Day 7 After Enrollment of Participants in a Randomized Controlled Trial That Introduced Point-of-Care Tests to Guide Management of Outpatients With Febrile Illness at 3 Clinical Sites in Uganda
| Aduku (Kwania District) | Nagongera (Tororo District) | Kihihi (Kanungu District) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Outcomea | Intervention, n/N (%) | Control, n/N (%) | RR [95% CI] |
Intervention, n/N (%) | Control, n/N (%) | RR [95% CI] |
Intervention, n/N (%) | Control, n/N (%) | RR [95% CI] |
| Total (all ages) | 30/401 (7.5%) | 42/399 (10.5%) | .71 [.45, 1.11] | 33/398 (8.3%) | 43/402 (10.7%) | .78 [.50, 1.19] | 8/390 (2.1%) | 13/410 (3.2%) | .65 [.27, 1.54] |
| Patient age categories | |||||||||
| <5 years | 10/116 (8.6%) | 4/67 (6.0%) | 1.44 [.47, 4.43] | 14/158 (8.9%) | 21/198 (10.6%) | .84 [.44, 1.59] | 0/90 (0.0%) | 5/112 (4.5%) | … |
| 5 to <10 years | 5/60 (8.3%) | 7/83 (8.4%) | .99 [.33, 2.96] | 7/69 (10.1%) | 7/66 (10.6%) | .96 [.36, 2.58] | 1/67 (1.5%) | 2/87 (2.3%) | .65 [.06, 7.01] |
| 10 to <15 years | 1/33 (3.0%) | 3/43 (7.0%) | .43 [.05, 3.99] | 2/23 (8.7%) | 1/21 (4.8%) | 1.83 [.18, 18.70] | 0/46 (0.0%) | 1/47 (2.1%) | … |
| ≥15 years | 14/192 (7.3%) | 28/206 (13.6%) | .54 [.29, .99] | 10/148 (6.8%) | 14/117 (12.0%) | .57 [.26, 1.23] | 7/187 (3.7%) | 5/164 (3.0%) | 1.23 [.40, 3.79] |
| Gender | |||||||||
| Female | 21/269 (7.8%) | 32/252 (12.7%) | .62 [.36, 1.04] | 14/226 (6.2%) | 23/243 (9.5%) | .65 [.35, 1.24] | 5/222 (2.3%) | 8/247 (3.2%) | .70 [.23, 2.09] |
| Male | 9/132 (6.8%) | 10/147 (6.8%) | 1.00 [.42, 2.39] | 19/172 (11.0%) | 20/159 (12.6%) | .88 [.49, 1.58] | 3/168 (1.8%) | 5/163 (3.1%) | .58 [.14, 2.40] |
| Enrollment period | |||||||||
| July–September 2020 | 0/7 (0.0%) | 1/7 (14.3%) | … | 0/12 (0.0%) | 2/14 (14.3%) | … | 0/0 | 0/0 | … |
| October–December 2020 | 3/88 (3.4%) | 8/84 (9.5%) | .36 [.10, 1.30] | 7/88 (8.0%) | 13/85 (15.3%) | .52 [.22, 1.24] | 0/82 (0.0%) | 2/87 (2.3%) | … |
| January–March 2021 | 8/114 (7.0%) | 11/120 (9.2%) | .77 [.32, 1.83] | 11/101 (10.9%) | 12/100 (12.0%) | .91 [.42, 1.96] | 4/111 (3.6%) | 4/120 (3.3%) | 1.08 [.28, 4.22] |
| April–June 2021 | 12/136 (8.8%) | 14/124 (11.3%) | .78 [.38, 1.62] | 8/131 (6.1%) | 13/132 (9.8%) | .62 [.27, 1.45] | 1/122 (0.8%) | 6/119 (5.0%) | .16 [.02, 1.33] |
| July–September 2021 | 7/56 (12.5%) | 8/64 (12.5%) | 1.00 [.39, 2.58] | 7/66 (10.6%) | 3/71 (4.2%) | 2.51 [.68, 9.31] | 3/75 (4.0%) | 1/84 (1.2%) | 3.36 [.36, 31.61] |
| Respiratory vs nonrespiratory syndromeb | |||||||||
| Respiratory | 16/206 (7.8%) | 19/179 (10.6%) | .73 [.39, 1.38] | 19/255 (7.5%) | 24/183 (13.1%) | .57 [.32, 1.00] | 3/187 (1.6%) | 2/59 (3.4%) | .47 [.01, 2.77] |
| Nonrespiratory | 14/195 (7.2%) | 23/220 (10.5%) | .69 [.36, 1.30] | 14/143 (9.8%) | 14/182 (7.7%) | 1.27 [.63, 2.58] | 5/203 (2.5%) | 11/351 (3.1%) | .79 [.28, 2.23] |
| mRDT result | |||||||||
| Positive | 11/217 (5.1%) | 16/189 (8.5%) | .60 [.29, 1.26] | 5/112 (4.5%) | 5/96 (5.2%) | .86 [.26, 2.87] | 3/171 (1.8%) | 5/188 (2.7%) | .66 [.16, 2.72] |
| Negative | 19/184 (10.3%) | 19/144 (13.2%) | .78 [.43, 1.42] | 28/286 (9.8%) | 19/163 (11.7%) | .84 [.49, 1.46] | 5/219 (2.3%) | 8/201 (4.0%) | .57 [.19, 1.73] |
Numerators (n) denote unfavorable outcomes.
Abbreviations: CI, confidence interval; mRDT, malaria rapid diagnostic test; RR, relative risk.
Unfavorable outcome was defined at day 7 as an elevated body temperature and/or reporting that day 0 symptoms had not improved.
As indicated by the managing clinician based on symptoms and signs, before performance of diagnostic tests.