| Study characteristics |
| Patient sampling |
Type of study: unclear whether prospective or retrospective study
Consecutive or random sample: consecutive patients |
| Patient characteristics and setting |
Sample size: 256
Female: not stated
Age: not stated
Presentation:
1. Patients with dyspepsia
Exlusion:
1. Gastric surgery
2. Recent treatment for ulcer or H pylori
3. Pulmonary failure
Setting: secondary care, Italy |
| Index tests |
Index test: urea breath test‐13C
Further details:
Technical specifications: AB Analitica
Performed by: not stated
Criteria for positive diagnosis: delta over baseline > 4.0% (30 minutes) |
| Target condition and reference standard(s) |
Target condition: H pylori infection
Reference standard: endoscopic biopsy (staining not reported, probably H & E)
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: 0 (0%) |
| Comparative |
|
| Notes |
|
| Methodological quality |
| Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
| DOMAIN 1: Patient Selection |
| Was a consecutive or random sample of patients enrolled? |
Yes |
|
|
| Was a case‐control design avoided? |
Yes |
|
|
| Did the study avoid inappropriate exclusions? |
Yes |
|
|
| |
|
Low |
Low |
| DOMAIN 2: Index Test Urea breath test‐13C |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
Unclear |
|
|
| If a threshold was used, was it pre‐specified? |
Yes |
|
|
| |
|
Unclear |
Low |
| DOMAIN 3: Reference Standard |
| Is the reference standards likely to correctly classify the target condition? |
No |
|
|
| Were the reference standard results interpreted without knowledge of the results of the index tests? |
Unclear |
|
|
| |
|
High |
Low |
| DOMAIN 4: Flow and Timing |
| Was there an appropriate interval between index test and reference standard? |
Unclear |
|
|
| Did all patients receive the same reference standard? |
Yes |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| |
|
Unclear |
|
