Lee et al. (2005) Prospective case 40 patients 4/40 procedures (10%): series 3 attachment failures Level: IV 1 early detachment Quality: Q3 CX P2 a These studies are not case series but are still included as level IV safety evidence because they do not report a(n) (appropriate) comparison regarding technical efficacy. Table Technical efficacy of catheter-free (wireless) oesophageal pH monitoring in children Study Study design N Technical/operative/equipment/recording failure Cabrera et al. (2011) Prospective case 289 children 41/289 procedures (14.2%) series 3 capsules failed to calibrate Level: IV 8 failures of attachment to the oesophageal Quality: Q1 mucosa CX 4 capsules failed to deploy from catheter P2 1 recording failure 4 early detachments 21 incomplete data captures Gunnarsdottir, Case series 58 children 3/58 procedures (5.2%): Stenstrom & Level: IV 1 transmission failure Arnbjornsson (2007, Quality: Q1 2 attachment failures 2008) CX P2 Hochman & Retrospective case 50 children 5/50 procedures (10%): Favaloro-Sabatier series 1 failure of attachment to the oesophageal (2005) Level: IV mucosa Quality: Q2 4 shorter monitoring periods CX P2
Lee et al. (2005) Prospective case series Level: IV Quality: Q3 CX P2 40 patients 4/40 procedures (10%): 3 attachment failures 1 early detachment a These studies are not case series but are still included as level IV safety evidence because they do not report a(n) (appropriate) comparison regarding technical efficacy. Table Technical efficacy of catheter-free (wireless) oesophageal pH monitoring in children Study Study design N Technical/operative/equipment/recording failure Cabrera et al. (2011) Prospective case series Level: IV Quality: Q1 CX P2 289 children 41/289 procedures (14.2%) 3 capsules failed to calibrate 8 failures of attachment to the oesophageal mucosa 4 capsules failed to deploy from catheter 1 recording failure 4 early detachments 21 incomplete data captures Gunnarsdottir, Stenstrom & Arnbjornsson (2007, 2008) Case series Level: IV Quality: Q1 CX P2 58 children 3/58 procedures (5.2%): 1 transmission failure 2 attachment failures Hochman & Favaloro-Sabatier (2005) Retrospective case series Level: IV Quality: Q2 CX P2 50 children 5/50 procedures (10%): 1 failure of attachment to the oesophageal mucosa 4 shorter monitoring periods
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx