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. 2021 May 6;2021(5):CD012972. doi: 10.1002/14651858.CD012972.pub2

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
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.
Outcomes Time to treatment initiation
Notes Target condition: tuberculosis
Case definition; bacteriological confirmation using smear microscopy, Xpert MTB/RIF, or culture
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