Study profiles of included studies on direct Direct evidence Study setting Study design / Study population Inclusion criteria / Exclusion Diagnostic tests Health outcomes assessed Quality appraisal criteria Grigolon et al. () Matched-pairs 102 patients Inclusion: Index test: Outcome of the principal retrospective cohort symptom Department of Catheter group: 51 All consecutive patients who System: Bravo™ wireless capsule system study Gastroenterology, patients, 20 males, mean underwent wireless 96-hour pH Insertion: NA Universita Degli age 48 years (range monitoring between January and Placement: 6 cm above the SCJ Studi and December 2007 off PPI therapy, Level: III-2 Duration: 48–96 hours Fondazione IRCCS and patients undergoing traditional Bravo group: 51 patients, Quality: 16.5/26 Comparator: Ca Granada, 24-hour pH monitoring in the same 22 males, mean age CX System: Slimline mod 901P3001, Ospedale Maggiore period, after matching for the most 48 years (range 23–82) P2 Medtronic, Denmark Policlinico, Milan, troublesome symptom potentially Italy to GORD, sex and age Insertion: transnasally Exclusion: Placement: 6 cm above the point of sudden change in pH from acid to neutral as Not stated detected by means of continuous rapid withdrawal from the stomach or 5 cm above the upper margin of the LOS Duration: 24 hours Sweis et al. () Case series 38 patients Inclusion: Index test: Improvement in symptoms / poor outcome (with 24-, 48-, Guy’s and St 13 males, 25 females Not stated System: Bravo™ wireless capsule system Bravo as a comparator) Thomas Hospitals, Level: IV Median age: 41.6 years Exclusion: Insertion: transorally London, UK (range 17–75) Quality: Q2 Not stated Placement: 6 cm proximal to the SCJ Indication: CX Duration: 96 hours Reflux symptoms and no P2 Comparator: diagnosis of GORD on (24-, 48-, 72-hour Bravo pH monitoring) catheter-based pH monitoring
Study profiles of included studies on direct Direct evidence Study setting Study design / Quality appraisal Study population Inclusion criteria / Exclusion criteria Diagnostic tests Health outcomes assessed Grigolon et al. () Department of Gastroenterology, Universita Degli Studi and Fondazione IRCCS Ca Granada, Ospedale Maggiore Policlinico, Milan, Italy Matched-pairs retrospective cohort study Level: III-2 Quality: 16.5/26 CX P2 102 patients Catheter group: 51 patients, 20 males, mean age 48 years (range Bravo group: 51 patients, 22 males, mean age 48 years (range 23–82) Inclusion: All consecutive patients who underwent wireless 96-hour pH monitoring between January and December 2007 off PPI therapy, and patients undergoing traditional 24-hour pH monitoring in the same period, after matching for the most troublesome symptom potentially to GORD, sex and age Exclusion: Not stated Index test: System: Bravo™ wireless capsule system Insertion: NA Placement: 6 cm above the SCJ Duration: 48–96 hours Comparator: System: Slimline mod 901P3001, Medtronic, Denmark Insertion: transnasally Placement: 6 cm above the point of sudden change in pH from acid to neutral as detected by means of continuous rapid withdrawal from the stomach or 5 cm above the upper margin of the LOS Duration: 24 hours Outcome of the principal symptom Sweis et al. () Guy’s and St Thomas Hospitals, London, UK Case series Level: IV Quality: Q2 CX P2 38 patients 13 males, 25 females Median age: 41.6 years (range 17–75) Indication: Reflux symptoms and no diagnosis of GORD on catheter-based pH monitoring Inclusion: Not stated Exclusion: Not stated Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm proximal to the SCJ Duration: 96 hours Comparator: (24-, 48-, 72-hour Bravo pH monitoring) Improvement in symptoms / poor outcome (with 24-, 48-, Bravo as a comparator)
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx