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 |