Study characteristics |
Patient sampling |
Type of study: unclear whether prospective or retrospective study
Consecutive or random sample: unclear sampling process |
Patient characteristics and setting |
Sample size: 33
Female: 16 (48.5%)
Age: 42 years
Presentation:
1. Patients undergoing upper gastrointestinal endoscopy
Setting: secondary care, Bulgaria |
Index tests |
Index test: serology
Further details:
Technical specifications: Rapid HP, US Meds
Performed by: not stated
Criteria for positive diagnosis: not stated |
Target condition and reference standard(s) |
Target condition: H pylori infection
Reference standard: endoscopic biopsy with Giemsa stain
Further details:
Technical specifications: not stated
Performed by: endoscopist and pathologist
Criteria for positive diagnosis: presence of H pylori in biopsy |
Flow and timing |
Number of indeterminates for whom the results of reference standard was available: not stated
Number of patients who were excluded from the analysis: not stated |
Comparative |
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Notes |
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Methodological quality |
Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
DOMAIN 1: Patient Selection |
Was a consecutive or random sample of patients enrolled? |
Unclear |
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Was a case‐control design avoided? |
Yes |
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Did the study avoid inappropriate exclusions? |
Unclear |
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Unclear |
Unclear |
DOMAIN 2: Index Test Serology |
Were the index test results interpreted without knowledge of the results of the reference standard? |
Unclear |
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If a threshold was used, was it pre‐specified? |
Unclear |
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Unclear |
High |
DOMAIN 3: Reference Standard |
Is the reference standards likely to correctly classify the target condition? |
Yes |
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Were the reference standard results interpreted without knowledge of the results of the index tests? |
Unclear |
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Unclear |
Low |
DOMAIN 4: Flow and Timing |
Was there an appropriate interval between index test and reference standard? |
Unclear |
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Did all patients receive the same reference standard? |
Yes |
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Were all patients included in the analysis? |
Unclear |
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Unclear |
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