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→Theron Feasibility accuracy clinical effect XpertTB primary care Africa RCT Lancet 2014
4. What is the target population and how was it selected? How representative is the population?
*Target population is not clearly mentioned, but it is TB patients possibly in sub-Saharan Africa according to "Introduction" section.
*Sample is selected out of 4 countries in southern Africa, i.e., S Africa, Zimbabwe, Zambia and Tanzania.
*If researchers' target population is sub-Sahara, southern African patients do not necessarily represent the population but might be said as closer.
*Inclusion criteria of each patient/participant is defined clear and plausible as untreated symptomatic TB status.
5. How are exposure variables and outcomes defined?
*Exposure
**All participants spontaneously expectorate two sputum specimens with each of them more than 1mL.
**One of the specimens were randomly assigned to POC GeneXpert or POC microscopy, the other was sent to lab for TB culture.
**The first and the last samples allocated to POC GeneXpert were also sent to lab to validate POC nurse techniques compared to trained technicians.
*Outcome
**as mentioned in question no.3
6. Was there potential for misclassification of the outcome?
*I don't think there was apparent misclassification of the outcome.
7. Was there potential for misclassification of the exposure?
*I don't think there was apparent misclassification of the exposure.
8. What outcome measure is used and is this appropriate for this type of study?
*I'm not sure what TBscore or KPS are nor appropriateness of using them for this outcome as well.
9. What other sources of bias are likely?
*It was impossible to blind against POC nurse and patients were impossible. It might introduce some bias for initiation of Tx and follow-up, like, POC nurse might have told participants as "You are lucky because you are quickly diagnosed by such a brand-new high-grade testing machine!"
10. Discuss the statistic
👉 did the analysis match the stated objectives?
*I think each of statistical analyses are matched to the objectives.
👉 was a sample size calculation reported?al analysis strategy.
*Sample size calculation is described in detail.
11. Discuss the tables (and figures if relevant). What is presented in each? Are the results presented clearly?
👉 Are there any data not presented that you think should have been?
*I couldn't have enough time to search possible missing data on the article, but possibly perfect (I want to believe)
12. Is their discussion of the results appropriate, and do they draw appropriate conclusions which can be justified based on the results presented?
*They discussed study results very much in detail and sincerely accepted the negative primary outcomes.
👉 do they discuss the strengths and limitations and potential sources of bias of the study? – do you agree with the authors?
*They discussed strengths and limitation of their study in detail, but I couldn't have enough time to verify their discussions.
