Agbenorku 2011.
Methods | Prospective observational study | |
Participants | Inclusion criteria: clinically + laboratory‐confirmed BU (exclusion: none stated) Laboratory confirmation: any 2 positives of ZN test for AFB, PCR, and histopathology Enrolled: 189 participants Participant characteristics: 113 males, 60%; age N/A Lesion types: ulcer 145 (76.7%), nodule 38 (20.1%), plaque 6 (3.2%) WHO category I: 44 (22.3%), categories II + III: 145 (76.7%) |
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Interventions | Rifampicin (10 mg/kg/d) + streptomycin (15 mg/kg/d), 8 weeks, with surgery Surgery: all cases Follow‐up: 2 years after discharge from hospital |
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Outcomes |
Standardized outcome: cure |
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Notes | Trial location: Ghana Enrolment dates: January 2005 to December 2005 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (Trials) | High risk | — |
Allocation concealment (Trials) | High risk | — |
Blinding of participants and personnel (Trials) | High risk | — |
Blinding of outcome assessment (Trials) | High risk | — |
Selection of participants into the study (Prospective observational studies) | Low risk | Selection not related to intervention or outcome. |
Measurement of outcomes (Prospective observational studies) | Low risk | Objective outcome measure (healing) |
Incomplete outcome data / missing data (All studies) | Low risk | 3 participants (3.2%) were lost to follow‐up but for different outcomes. |
Selective reporting (All studies) | Low risk | Reported all expected outcomes |
Other bias | Low risk | No other bias identified. |