Study profiles of included studies on linked evidence Diagnostic accuracy Study setting Study design / Study population Inclusion criteria / Exclusion Diagnostic tests Diagnostic accuracy Quality appraisal criteria outcome assessed Sensitivity Ayazi et al. () Diagnostic 25 asymptomatic subjects Inclusion: Index test: Specificity study and 25 patients Department of Not stated System: Bravo™ wireless capsule system, Accuracy Surgery, Keck Indications: Medtronic Inc. Minneapolis Minnesota Exclusion: School of Medicine, Level: III-3 Patients had heartburn Insertion: transnasally Not stated University of and were responsive to Quality: Placement: 5 cm above the LOS Southern California, PPI therapy. All had hiatal Patient selection: ? Duration: 48 hours Los Angeles, hernia Index test: ? Comparator: NA California, USA Reference Reference standard: standard: Clinical diagnosis (heartburn, responsive to PPI Flow and timing: ? therapy and evidence of a hiatal hernia) CX P3 Sensitivity Ayazi et al. ()11 Diagnostic 115 symptomatic patients Inclusion: Index test: Specificity study who were tested for Department of Not stated System: Bravo™ wireless capsule system, PPV GORD (28 patients with Surgery, Keck Medtronic Inc. Minneapolis Minnesota Exclusion: NPV strong clinical evidence, School of Medicine, Level: III-3 Insertion: transnasally Not stated Accuracy 77 with intermediate University of Quality: Placement: 5 cm above the LOS evidence, and 10 with Southern California, Patient selection: Duration: 48 hours minimal evidence, of Los Angeles, Index test: ? Comparator: GORD California, USA Reference NA standard: Reference standard: Flow and timing: Clinical diagnosis (primary symptoms of CX heartburn and/or regurgitation, response to PPI therapy >50%, hiatal hernia >2 cm, P3 oesophageal mucosal injury)
Study profiles of included studies on linked evidence Diagnostic accuracy Study setting Study design / Quality appraisal Study population Inclusion criteria / Exclusion criteria Diagnostic tests Diagnostic accuracy outcome assessed Ayazi et al. () Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA Diagnostic study Level: III-3 Quality: Patient selection: ? Index test: ? Reference standard: Flow and timing: ? CX P3 25 asymptomatic subjects and 25 patients Indications: Patients had heartburn and were responsive to PPI therapy. All had hiatal hernia Inclusion: Not stated Exclusion: Not stated Index test: System: Bravo™ wireless capsule system, Medtronic Inc. Minneapolis Minnesota Insertion: transnasally Placement: 5 cm above the LOS Duration: 48 hours Comparator: NA Reference standard: Clinical diagnosis (heartburn, responsive to PPI therapy and evidence of a hiatal hernia) Sensitivity Specificity Accuracy Ayazi et al. ()11 Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA Diagnostic study Level: III-3 Quality: Patient selection: Index test: ? Reference standard: Flow and timing: CX P3 115 symptomatic patients who were tested for GORD (28 patients with strong clinical evidence, 77 with intermediate evidence, and 10 with minimal evidence, of GORD Inclusion: Not stated Exclusion: Not stated Index test: System: Bravo™ wireless capsule system, Medtronic Inc. Minneapolis Minnesota Insertion: transnasally Placement: 5 cm above the LOS Duration: 48 hours Comparator: NA Reference standard: Clinical diagnosis (primary symptoms of heartburn and/or regurgitation, response to PPI therapy >50%, hiatal hernia >2 cm, oesophageal mucosal injury) Sensitivity Specificity PPV NPV Accuracy
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx