Table Diagnostic accuracy of catheter-free monitoring compared to clinical diagnosis for diagnosing GORD in adults Study Evidence level Population Index test & Reference Sensitivity Specificity PPV % NPV % LR+ LR– Accuracy and quality cut-off point standard & % [95%CI] % [95%CI] [95%CI] [95%CI] [95%CI] cut-off point Wenner, Level: III-3 119 Bravo pH Clinical 1.9: 88% 1.9: 75% - - 1.9: 3.52 1.9: 0.16 - Johansson subjects (64 monitoring diagnosis Quality: 2.2: 86% 2.2: 80% 2.2: 4.30 2.2: 0.18 et al. (2007), patients and Patient selection: 2.3: 83% 2.3: 80% 2.3: 4.15 2.3: 0.21 Wenner et 55 controls) Time under pH Index test: ? 3.2: 68% 3.2: 85% 3.2: 4.53 3.2: 0.38 al. (2008) 4 >1.9, 2.2, 2.3, Reference 3.6: 64% 3.6: 91% 3.6: 7.11 3.6: 0.40 3.2, 3.6 and 4.4 standard: 4.4: 59% 4.4: 96% 4.4: 14.75 4.4: 0.43 Diagnostic Flow and timing: ? case-control CX study P3 Bansal et al. Level: III-3 56 subjects Bravo pH Clinical Proximal: Proximal: - - - - - (2009) (40 patients monitoring diagnosis (no 67% 66% Quality: and 16 Time symptoms of Distal: 60% Distal: 88% Patient selection: controls) under pH 4 reflux in control Diagnostic Index test: ? >4.4% for the population) case-control Reference proximal study standard: location (6 cm above GOJ), Flow and timing:? and time under CX pH 4 >10.6% P2 for the distal location (1 cm above GOJ)
Table Diagnostic accuracy of catheter-free monitoring compared to clinical diagnosis for diagnosing GORD in adults Study Evidence level and quality Population Index test & cut-off point Reference standard & cut-off point Sensitivity % [95%CI] Specificity % [95%CI] PPV % [95%CI] NPV % [95%CI] LR+ LR– Accuracy [95%CI] Wenner, Johansson et al. (2007), Wenner et al. (2008) Diagnostic case-control study Level: III-3 Quality: Patient selection: Index test: ? Reference standard: Flow and timing: ? CX P3 119 subjects (64 patients and 55 controls) Bravo pH monitoring Time under pH 4 >1.9, 2.2, 2.3, 3.2, 3.6 and 4.4 Clinical diagnosis 1.9: 88% 2.2: 86% 2.3: 83% 3.2: 68% 3.6: 64% 4.4: 59% 1.9: 75% 2.2: 80% 2.3: 80% 3.2: 85% 3.6: 91% 4.4: 96% - - 1.9: 3.52 2.2: 4.30 2.3: 4.15 3.2: 4.53 3.6: 7.11 4.4: 14.75 1.9: 0.16 2.2: 0.18 2.3: 0.21 3.2: 0.38 3.6: 0.40 4.4: 0.43 - Bansal et al. (2009) Diagnostic case-control study Level: III-3 Quality: Patient selection: Index test: ? Reference standard: Flow and timing:? CX P2 56 subjects (40 patients and 16 controls) Bravo pH monitoring Time under pH 4 >4.4% for the proximal location (6 cm above GOJ), and time under pH 4 >10.6% for the distal location (1 cm above GOJ) Clinical diagnosis (no symptoms of reflux in control population) Proximal: 67% Distal: 60% Proximal: 66% Distal: 88% - - - - -
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