Smith 2001.
Methods | This was an open‐label RCT. | |
Participants | The treatment setting was multicentre. There were 27 participants in the initial sample. The total evaluable sample was 17 participants (group 1 = 10 participants; group 2 = 7 participants). Exclusion criteria of the trial
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Interventions |
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Outcomes |
Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Pharmaceutical involvement of the co‐authors was declared; however, funding was not addressed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: The method of randomisation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Comment: The authors did not report how allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "...open label." Comment: Participants were not blinded; they were aware of which treatment arm they were allocated. |
Blinding (performance bias and detection bias) All outcomes | High risk | Comment: There was no report regarding who allocated treatment/provided medication. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "...open label." Comment: The outcome assessors were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "27 HIV‐positive participants were enrolled in the study... ten participants subsequently were excluded because of negative initial culture results (n = 9) or loss to follow up (n = 1)." Comment: Those lost to follow up or excluded were accounted for. The attrition rate was 37%. An intention‐to‐treat analysis was done. |
Selective reporting (reporting bias) | Low risk | Comment: The study protocol was not available. However, the outcomes stated in the methods of the report were all described in the results and discussion. |
Other bias | High risk | Quote: "There were no differences in baseline demographics or disease characteristics except for the duration of target infection. The mean duration was less than half as long for the 2‐week group compared to the 4‐week group (151 weeks versus 376 weeks)." Comment: The duration of infection at baseline was substantially different for the 2 groups. |