Yoon 2012.
| Study characteristics | ||
| Methods | A multicentre implementation study of Xpert MTB/RIF with two phases: baseline and implementation phases, using a cohort of patients at the Mulago national referral hospital | |
| Participants | 18 years old and older History of cough for more than two weeks, but less than six months 48% female HIV infection: 76% setting: Mulago national referral hospital Country: Uganda Sample size: 477 |
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| Interventions | In the baseline phase (August 2009 to March 2010), Xpert MTB/RIF results were not reported to clinicians, or used for patient management. This phase allowed for the collection of baseline data on study outcomes, and was necessary for local validation of Xpert MTB/RIF performance compared with conventional laboratory methods. In the subsequent implementation phase (March 2010 to August 2010), Xpert MTB/RIF results were provided to clinicians, and were used to inform tuberculosis treatment decisions. Each sample underwent smear microscopy, Xpert MTB/RIF, and culture. | |
| Outcomes | Primary outcome: two‐month mortality Secondary outcome: time to tuberculosis detection and treatment |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | A pre and post study design without randomization |
| Allocation concealment (selection bias) | High risk | Allocation of intervention was determined by calender dates |
| Baseline characteristics similar (selection bias) | Low risk | Baseline characteristics were reported; were not significantly different |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Protection against contamination (performance bias) | Low risk | No Xpert MTB/RIF data were used for clinical management during the baseline period |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment was not possible, and it is unclear whether blinding could have affected the assessment of mortality |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up was significantly different between the before and after intervention periods |
| Selective reporting (reporting bias) | Low risk | All outcomes in the methods were reported |
| Other bias | High risk | Risk of confounding due to pre‐post design |
DST (PPV): drug sensitive test TB: tuberculosis hr: hour IPT: isoniazid preventive therapy MDR‐TB: multi‐drug resistant tuberculosis