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→Theron Feasibility accuracy clinical effect XpertTB primary care Africa RCT Lancet 2014
==Theron Feasibility accuracy clinical effect XpertTB primary care Africa RCT Lancet 2014==
1. What is the rationale for the study? Is it clear and sensible?
*Researchers tried to establish the value of implementing GeneXpert MTB/RIF in primary care facilities in southern Africa.
*Their rationale is clear and sensible.
2. What are the aim and objectives of the study? Are they clear and unambiguous?
*Their aim and objective are to assess feasibility and diagnostic accuracy as well as clinical outcome of TB treatment.
*They are clear and unambiguous.
👉 Was there a clearly identified primary outcome
*Primary outcomes are clearly defined as TB-related morbidity measured by TBscore and Karnofsky performance score in culture-positive patients at 2 and 6 months after randomization.
3. What is the study design, exposure of interest and outcome of interest?
*Design: randomized controlled trial
*Exposure: diagnosis of TB by GeneXpert at POC versus smear microscopy at POC
*Primary outcomes:
**TB-related morbidity, mean of TBscore and KPS, in culture-positive patients who had begun TB-Tx; measured at 2 and 6 months after randomization
*Secondary outcomes:
**feasibility of POC GeneXpert test
***accuracy
***failure rates
***operator protocol adherence
***user appraisals
**time to diagnosis
***oveall/day1/2/3/14/28/56
**time to TB-Tx initiation
***overall/day1/2/3/14/28/56
**proportion of culture-positive pts not started on TB-Tx (= dropout)
**lost to follow-up
4. What is the target population and how was it selected? How representative is the population?
5. How are exposure variables and outcomes defined?
6. Was there potential for misclassification of the outcome?
7. Was there potential for misclassification of the exposure?
8. What outcome measure is used and is this appropriate for this type of study?
9. What other sources of bias are likely?
10. Discuss the statistic
👉 did the analysis match the stated objectives?
👉 was a sample size calculation reported?al analysis strategy.
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?
12. Is their discussion of the results appropriate, and do they draw appropriate conclusions which can be justified based on the results presented?
👉 do they discuss the strengths and limitations and potential sources of bias of the study? – do you agree with the authors?
