Appendix Studies included in the review Study profiles of included studies on safety Study setting Study design / Study population Inclusion criteria / Exclusion criteria Diagnostic tests Safety outcomes Quality appraisal assessed Mild epigastric pain Agrawal, Case report 1 patient Inclusion: Index test: Severe retrosternal Akerman & Rich 45 year old female NA System: Bravo™ wireless capsule system chest discomfort () Level: NA Indication: Exclusion: Insertion: not stated Rhode Island Persistent heartburn despite maximal NA Placement: 6 cm above the SCJ Hospital, Warren acid-suppressive therapy Alpert Medical Duration: not stated School of Brown University, Providence, Rhode Island, USA Chest pain Ahlawat et al. () Retrospective 90 patients Inclusion: Index test: Foreign-body case series Division of 48 males and 42 females Not stated System: Bravo™ wireless capsule system sensation Gastroenterology, Age range: 18–80 years Exclusion: Insertion: transorally Department of Level: IV Indications: Patients with bleeding diathesis, Placement: 6 cm proximal to the SCJ Medicine, Quality: Q1 strictures, severe oesophagitis, varices, Georgetown Being to the conventional Duration: 48 hours obstructions, pacemakers, implantable University CX (no naso-oesophageal pH catheter Comparator: NA cardiac defibrillators, and surgical Hospital, comparator) placement or had normal 24-hour manipulations of the upper GI tract Washington, DC, oesophageal pH monitoring despite P2 USA symptoms Manometry Andrews et al. () Dual centre, 86 patients Inclusion: Index test: discomfort (nasal, randomised, Division of (40 in Calgary and 46 in Edmonton) Patients aged 18–75 years referred for System: activated and calibrated Bravo™ throat, chest, blinded trial Gastroenterology, ambulatory pH monitoring between wireless capsule system, Medtronic Inc., overall) 61 females, 25 males University of August 2008 and August 2009 Minneapolis, MN pH placement Age range 18–75 years Calgary, Canada Level: II Exclusion: Insertion: transorally discomfort (nasal,
Appendix Studies included in the review Study profiles of included studies on safety Study setting Study design / Quality appraisal Study population Inclusion criteria / Exclusion criteria Diagnostic tests Safety outcomes assessed Agrawal, Akerman & Rich () Rhode Island Hospital, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA Case report Level: NA 1 patient 45 year old female Indication: Persistent heartburn despite maximal acid-suppressive therapy Inclusion: NA Exclusion: NA Index test: System: Bravo™ wireless capsule system Insertion: not stated Placement: 6 cm above the SCJ Duration: not stated Mild epigastric pain Severe retrosternal chest discomfort Ahlawat et al. () Division of Gastroenterology, Department of Medicine, Georgetown University Hospital, Washington, DC, USA Retrospective case series Level: IV Quality: Q1 CX (no comparator) P2 90 patients 48 males and 42 females Age range: 18–80 years Indications: Being to the conventional naso-oesophageal pH catheter placement or had normal 24-hour oesophageal pH monitoring despite symptoms Inclusion: Not stated Exclusion: Patients with bleeding diathesis, strictures, severe oesophagitis, varices, obstructions, pacemakers, implantable cardiac defibrillators, and surgical manipulations of the upper GI tract Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm proximal to the SCJ Duration: 48 hours Comparator: NA Chest pain Foreign-body sensation Andrews et al. () Division of Gastroenterology, University of Calgary, Canada Dual centre, randomised, trial Level: II 86 patients (40 in Calgary and 46 in Edmonton) 61 females, 25 males Age range 18–75 years Inclusion: Patients aged 18–75 years referred for ambulatory pH monitoring between August 2008 and August 2009 Exclusion: Index test: System: activated and calibrated Bravo™ wireless capsule system, Medtronic Inc., Minneapolis, MN Insertion: transorally Manometry discomfort (nasal, throat, chest, overall) pH placement discomfort (nasal, blinded
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx