Kamolratanakul 1999 THA.
Methods | Generation of allocation sequence: central block random allocation scheme prepared for each of 15 trial sites; random‐number table used. Allocation concealment: none. Blinding: no blinding of assessors. Completeness of follow‐up: 100% (no losses). |
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Participants | Number: 837 randomized; 73% male. Included: new smear positive adults (aged 15+). |
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Interventions |
All participants received the same drug regimen: isoniazid‐rifampicin‐pyrazinamide‐ethambutol for 2 months and isoniazid‐rifampicin for 4 months. |
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Outcomes |
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Notes | Location: Thailand. Date: 1996 to 1997. Duration of DOT not stated. Informed consent not obtained as participants were not told that they were participating in a study. Choice of supervisor for DOT participants: 352 chose a family member; 34 chose a community member; and 24 chose health centre staff. One participant in daily supervision arm excluded due to protocol violation so not strictly intention‐to‐treat. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Generated using random number tables. |
Allocation concealment (selection bias) | Unclear risk | Inadequate information. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Investigators not blinded though the patients were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no exclusions. |
Selective reporting (reporting bias) | Unclear risk | All outcomes stated in the methodology are reported. |
Other bias | Unclear risk | Not applicable. |