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. 2017 May 25;2017(5):CD008892. doi: 10.1002/14651858.CD008892.pub2
Quality indicator Notes
1. Patient selection
Was a consecutive or random sample of patients enrolled? Yes: if the study recruited a consecutive or random sample of eligible patients
No: if the study selected patients by convenience
Unclear: if the study did not report the method of patient selection, or this was not clearly reported
Was a case control design avoided? Yes: if the study recruited unselected febrile patients
No: if the study recruited confirmed or suspected cases of enteric fever, or both as a case group
Unclear: for all other scenarios or if this was not clearly reported
Did the study avoid inappropriate exclusions? Yes: if there were no participants excluded from the analysis, or if exclusions were adequately described.
No: if there were unexplained exclusion of participants
Unclear: if insufficient information was given to assess whether any participants were excluded from the analysis
Could the selection of patients introduced bias? Low risk: inclusion and exclusion criteria clearly described, for example, patients with fever, patients suspected to have enteric fever, or both
High risk: inclusion and exclusion criteria not included
Unclear risk: If selection criteria were partially reported
Are there concerns that the included patients and setting do not match the review question? Low concern: patients with fever and recruited from an area of high or medium endemicity for enteric fever as defined by Crump 2004
High concern: patients without fever or recruited from an area of low endemicity for enteric fever (Crump 2004)
Unclear concern: if the location or clinical characteristics of participants were not adequately described
2. Index test
Were the index test results interpreted without knowledge of the results of the reference standard? Yes: person undertaking the index test did not know the results of the reference tests, or if the tests were carried out in different places
No: if the same person performed both tests, or the results of the reference tests were known to the person undertaking the index tests
Unclear: if insufficient information provided
If a threshold was used, was it pre‐specified? Yes: if the threshold's pre‐specified by the respective manufacturers were described and followed
No: if the manufacturer's thresholds were described but not followed
Unclear: if this is not clearly described or there were no thresholds for the evaluated RDT
Could the conduct or interpretation of the index test have introduced bias? Low risk: if the index test was utilized according to manufacturers' instructions
High risk: if the use of index tests(s) deviated from manufacturers' instructions
Unclear risk: if insufficient information provided
Are there concerns that the index test, its conduct, or interpretation differ from the review question? Low concern: if the index test was used to diagnose enteric fever in symptomatic patients from areas of high or medium enteric fever endemicity (Crump 2004)
High concern: if the index test was used to diagnose enteric fever in patients from areas of low endemicity for enteric fever (Crump 2004), or those who are asymptomatic
Unclear concern: if the location or clinical characteristics of participants were not described
3. Reference standard
Is the reference standard likely to correctly identify the target condition? Yes: if bone marrow and blood culture (Grade 1 Reference standard) are performed at an externally accredited laboratory and adequate blood/marrow volumes were taken (Wain 1998; Wain 2001)
No: If inadequate blood/marrow volumes were taken (Wain 1998; Wain 2001)
Unclear: if blood culture alone (Grade 2 Reference standard) is performed, or if external quality assurance accreditation of the relevant laboratory or blood/marrow volumes were not described
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes: person undertaking the reference test did not know the results of the index tests, or if the tests were carried out in different places
No: if the same person performed both tests, or the results of the index tests were known to the person undertaking the reference tests
Unclear: if insufficient information provided
Could the reference standard, its conduct, or its interpretation have introduced bias? Low risk: if the reference standard results and index tests were analysed separately
High risk: if the reference standard results and index tests results were analysed together
Unclear risk: if insufficient information was provided
Are there concerns that the target condition as defined by the reference standard does not match the question? We will judge this to be 'low risk' for all studies that use isolation of Salmonella Typhi, or Paratyphi A, or both from blood,bone marrow, or both.
4. Flow and timing
Was there an appropriate interval between index test and reference standard? Yes: if the index test and reference standard(s) were collected on the same patients at the same time or within 24 hours of each other
No: if the time period between index test and reference standard(s) collection was > 24 hours
Unclear: if the time period between index test and reference standard collection was not described
Did all patients receive the same reference standard? Yes: if the same reference test(s) was/were used in all participants
No: if different reference test(s) was/were used depending on index test results
Unclear: if insufficient information was provided
Were all patients included in the analysis? Yes: if the number of participants in the two‐by‐two table matched the number of participants recruited into the study or if sufficient explanation was provided for any discrepancy.
No: number of participants in the two‐by‐two table did not match the number of participants recruited into the study and insufficient explanation was provided for any discrepancy
Unclear: if insufficient information was given to permit judgement