Protocol	Review
Title
Impact of diagnostic test Xpert MTB/RIF® on health outcomes for tuberculosis	Impact of the diagnostic test Xpert MTB/RIF on patient outcomes for tuberculosis
Outcomes
Primary outcomes All‐cause mortality during trial follow‐up by time from first contact with health care Number of tuberculosis cases reported,and the number of drug sensitive and number of drug resistance tuberculosis reported. Proportion of participants treated Proportion of participants microbiologically confirmed and treated Proportion of participants not microbiologically confirmed but treated Secondary outcomes Time from first contact to initiation treatment Proportion of pre‐treatment lost to follow‐up Proportion of study participants who were diagnosed with or treated with MDR/TB Number of the visit prior to diagnosis Self‐reported satisfaction	During review, some primary outcomes were moved to secondary outcomes following the advice of the reviewers. We also used more specific wording for the outcomes. Primary outcomes All‐cause mortality during trial follow‐up from time from first contact with healthcare The proportion of participants treated for tuberculosis who had a successful treatment outcome (This outcome was included after a request from the WHO guideline development group for policy update on Xpert MTB/RIF) Secondary outcomes Proportion of participants treated for tuberculosis Proportion of participants treated for tuberculosis who were microbiologically confirmed Proportion of participants with microbiological confirmation who had pre‐treatment loss to follow‐up
Subgroup analysis
In the protocol we planned to conduct the following subgroup analysis: in participants with and without HIV and tuberculosis, in participants with pulmonary and extrapulmonary tuberculosis, in children and adults, in participants with drug‐resistant and non‐drug resistant tuberculosis	During the review, the only subgroup analysis we were able to perform was for mortality in participants by HIV status. Other planned analyses were not feasible due to lack of data availability. We introduced one subgroup analysis that we had not planned in the protocol: mortality assessed at six months. Mortality assessed at six month would provide relevant data to understand impact of Xpert MTB/RIF during treatment.
Selection and review of studies
In the protocol, we had indicated FH and RN to review studies	In the review, studies were reviewed by FH and MK.
In the protocol, the affiliation for Claudia Denkinger was FIND Geneva	In the review, the affiliation for Claudia Denkinger is both the Division of Tropical Medicine, Center of Infectious Diseases, University of Heidelberg, Germany and FIND, Geneva. Claudia Denkinger no longer works for FIND.