Appendix F Non-comparative technical efficacy data Table Technical efficacy of catheter-free (wireless) oesophageal pH monitoring in adults Study Study design N Technical/operative/equipment/recording failure Lacy et al. (2011) Case series 358 patients 6/358 procedures: (1.7%) Level: IV 6 early detachments or loss of signal Quality: Q1 CX P2 Nusrat, Roy & Retrospective case 356 patients 6/356 procedures: (1.7%) Bielefeldt (2012) series 6 early detachments Level: IV Quality: Q1 CX P2 Park et al. 2013 Case series 230 patients 32/230 procedures: (13.9%) (2013) Level: IV 17 early detachments Quality: Q1 10 attachment failures or misplacements CX 5 recording failures P2 Tseng et al. Retrospective case 209 patients (and 213 23/213 procedures (10.8%): (2005) series procedures) 18 incomplete data captures (<18 hours on at least Level: IV 1 day) Quality: Q1 5 early detachment CX P2 Crowell et al. Case series 180 patients 15/180 procedures (8.3%) (2009) Level: IV 15 early detachments Quality: Q1 CX P2 Doma et al. Post-test case series 161 patients 56/161 procedures: (38.0%) (2010) Level: IV 56 errors in placement (inaccurate placement of the capsule) Quality: Q1 CX P2 Iqbal et al. (2007) Retrospective case 100 patients 11/100 procedures (11.0%) series 11 early detachments Level: IV Quality: Q1 CX P2 Ahlawat et al. Retrospective case 90 patients 9/90 procedures: (10.0%) (2006) series 3 failure to transmit data to receiver Level: IV 1 capsule failed to deploy from catheter Quality: Q1 4 incomplete data captures CX 1 failure of attachment to the oesophageal mucosa P2
Appendix F Non-comparative technical efficacy data Table Technical efficacy of catheter-free (wireless) oesophageal pH monitoring in adults Study Study design N Technical/operative/equipment/recording failure Lacy et al. (2011) Case series Level: IV Quality: Q1 CX P2 358 patients 6/358 procedures: (1.7%) 6 early detachments or loss of signal Nusrat, Roy & Bielefeldt (2012) Retrospective case series Level: IV Quality: Q1 CX P2 356 patients 6/356 procedures: (1.7%) 6 early detachments Park et al. 2013 (2013) Case series Level: IV Quality: Q1 CX P2 230 patients 32/230 procedures: (13.9%) 17 early detachments 10 attachment failures or misplacements 5 recording failures Tseng et al. (2005) Retrospective case series Level: IV Quality: Q1 CX P2 209 patients (and 213 procedures) 23/213 procedures (10.8%): 18 incomplete data captures (<18 hours on at least 1 day) 5 early detachment Crowell et al. (2009) Case series Level: IV Quality: Q1 CX P2 180 patients 15/180 procedures (8.3%) 15 early detachments Doma et al. (2010) Post-test case series Level: IV Quality: Q1 CX P2 161 patients 56/161 procedures: (38.0%) 56 errors in placement (inaccurate placement of the capsule) Iqbal et al. (2007) Retrospective case series Level: IV Quality: Q1 CX P2 100 patients 11/100 procedures (11.0%) 11 early detachments Ahlawat et al. (2006) Retrospective case series Level: IV Quality: Q1 CX P2 90 patients 9/90 procedures: (10.0%) 3 failure to transmit data to receiver 1 capsule failed to deploy from catheter 4 incomplete data captures 1 failure of attachment to the oesophageal mucosa
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx