Van den Handel 2015.
| Study characteristics | ||
| Methods | A before‐and‐after implementation study | |
| Participants | All age groups Individuals were screened for signs and symptoms of tuberculosis (cough for 2 weeks, weight loss, night sweats) Female: 46% smear microscopy period, 46% Xpert MTB/RIF decentralized period HIV: 32% smear microscopy period, 27% Xpert MTB/RIF decentralized period Settings: National Health Laboratory services (NHLS) laboratories and peripheral hospitals (district, sub‐district, and primary healthcare facilities) in a district municipality Sample size: 584 smear microscopy period, and 375 Xpert MTB/RIF decentralized period |
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| Interventions | Tuberculosis diagnosis and treatment initiation were evaluated at six of the nine towns/communities in the Karoo, during three distinct periods. We extracted estimates from the smear microscopy and decentralized Xpert periods. Between April and October 2011 (the smear microscopy period), all sputum samples were sent for smear microscopy to the assigned NHLS laboratory. In October 2011, a single one‐module Xpert instrument was placed in a safe, secure space at hospitals located in Laingsburg, Murraysburg, and Prince Albert (the decentralized Xpert period), and the three nurses in charge of tuberculosis care were trained in performing the assay. |
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| Outcomes | Time to treatment initiation | |
| Notes | Target condition: tuberculosis Case definition; bacteriological confirmation using smear microscopy, Xpert MTB/RIF, or culture |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Pre‐ and post‐study allocation was determined by calendar dates |
| Allocation concealment (selection bias) | High risk | Allocation was not concealed |
| Baseline characteristics similar (selection bias) | Low risk | Baseline characteristics were similar |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding due to study design |
| Protection against contamination (performance bias) | Low risk | Xpert MTB/RIF allocated after smear microscopy period, and in areas which were geographically apart, minimal risk of contamination |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding was done, but outcomes were objective |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up was reported during smear period, no clear reports on number of participants who were lost to follow‐up during Xpert MTB/RIF |
| 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 |