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How to Critically Appraise A Diagnostic Article

How to Critically Appraise A Diagnostic Article. Sandy De Groote. Clinical Situation.

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How to Critically Appraise A Diagnostic Article

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  1. How to Critically Appraise A Diagnostic Article Sandy De Groote

  2. Clinical Situation • A doctor comes to you. She has a 21 year old male patient she suspects has an ulcer and wants to do a test for H. pylori infection. She has heard of a new stool antigen test that she hopes will be less invasive and less expensive than other tests. The doctor wants to know more about this test.

  3. PICO • P: Young adult with possible H Pylori • I: How accurate is stool antigen test • C: In comparison with other tests • O: Diagnosis H. Pylori Infection

  4. Search • PubMed Clinical Queries (diagnosis, specificity) • Helicobacter pylori AND stool antigen AND non-invasive

  5. The Article Selected • Diagnosis of Helicobacter Pylori infection with a new non-invasive antigen-based assay Lancet 1999; 354:30-33

  6. Methods • Design: Prospective • Setting: Multicentre study (11) in Europe • Patients: 501 (276 male, 255 women); Age range 17-88 years; Undergoing gastroscopy at endoscopy • Description of diagnostic tests: Presence of H. Pylori was invasively confirmed if histology (antrum, corpus, or both) and urease test were positive, or if culture was positive. (Gold Standard – proven method) • Presence of H. Pylori was non-invasively confirmed if antigens were found in stool samples using the HpSA (Meridian Diagnostics) (new diagnostic test) • Patients classified as having H Pylori infection received an eradication regimen; 107 were reassessed 4 weeks after therapy

  7. Issues of Validity • Was there an independent, blind comparison with a reference (“gold”) standard of diagnosis? – Yes • Was the diagnostic test evaluated in an appropriate spectrum of patients? Yes • Was the reference standard applied regardless of the diagnostic test result? Yes

  8. Results • Look at results in paper • -examined urea breath test • Stool antigen test (what we will examine) • Table 1 (pg 31) • Use 2X2 Diagnostic Test Calculator found at ebm.peds.uic.edu • Crunch in the numbers – various approaches

  9. Applicability • Stool antigen tests could be used reliably to diagnosis H.pylori

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