Disease, Ersta Level: III-3 30 females and 15 males Volunteers: history of GORD or any Duration: 48 hours LR– Hospital, in volunteer group other pathology of the upper GI Quality: Comparator: Stockholm, Sweden tract, taking acid-suppressing 27 females and 20 males Patient selection: ? System: Slimline, Medtronic, Skovlunde, agents or medication known to in patient group Denmark Index test: affect GI motility Mean age: Insertion: transnasally Reference Volunteers: 47 years standard: ? Placement: 5 cm proximal to the upper border (range 21–68) of the LOS Flow and timing: Patients: 50 years (range Duration: 24 hours C1 23–69) P2 Indication: Patients had symptoms including mainly heartburn, acid regurgitation, and chest or epigastric pain Pandolfino et al. () Sensitivity Diagnostic 44 controls (13 males, 31 Inclusion: Index test: Specificity Northwestern study females, aged Not stated System: Bravo™ wireless capsule system PPV University Feinberg years) Exclusion: Insertion: transorally NPV School of Medicine, 41 patients Level: III-3 Controls: abdominal symptoms, use Placement: 6 cm above the SCJ LR+ Chicago, Illinois, (26 males, 15 females, Quality: of antacids or antisecretory Comparator: NA LR– USA aged 32–72 years) medication, abnormal endoscopy Patient selection: Reference standard (diagnosis of patients in Patients: history of surgical Index test: ? study population): manipulation of the upper GI tract, Reference 25 patients had erosive oesophagitis, 6 had an history of bleeding diathesis or standard: ? abnormal 24-hour pH study, 10 were diagnosed coagulopathy, stroke or transient clinically with typical GORD symptoms that Flow and timing: ischemic attack in the past resolved with PPI therapy Q1 6 months, significant medical CX (clinical illness, oesophageal varices diagnosis) P3 Wenner, Johnsson Sensitivity Randomised 35 patients (31 patients Inclusion: Index test: et al. () Specificity crossover trial had enough data to be Patients referred for oesophageal System: Bravo™ wireless capsule system PPV Department of included) pH monitoring Insertion: transorally NPV Surgery, Lund
Disease, Ersta Hospital, Stockholm, Sweden Level: III-3 Quality: Patient selection: ? Index test: Reference standard: ? Flow and timing: C1 P2 30 females and 15 males in volunteer group 27 females and 20 males in patient group Mean age: Volunteers: 47 years (range 21–68) Patients: 50 years (range 23–69) Indication: Patients had symptoms including mainly heartburn, acid regurgitation, and chest or epigastric pain Volunteers: history of GORD or any other pathology of the upper GI tract, taking acid-suppressing agents or medication known to affect GI motility Duration: 48 hours Comparator: System: Slimline, Medtronic, Skovlunde, Denmark Insertion: transnasally Placement: 5 cm proximal to the upper border of the LOS Duration: 24 hours LR– Pandolfino et al. () Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA Diagnostic study Level: III-3 Quality: Patient selection: Index test: ? Reference standard: ? Flow and timing: Q1 CX (clinical diagnosis) P3 44 controls (13 males, 31 females, aged years) 41 patients (26 males, 15 females, aged 32–72 years) Inclusion: Not stated Exclusion: Controls: abdominal symptoms, use of antacids or antisecretory medication, abnormal endoscopy Patients: history of surgical manipulation of the upper GI tract, history of bleeding diathesis or coagulopathy, stroke or transient ischemic attack in the past 6 months, significant medical illness, oesophageal varices Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm above the SCJ Comparator: NA Reference standard (diagnosis of patients in study population): 25 patients had erosive oesophagitis, 6 had an abnormal 24-hour pH study, 10 were diagnosed clinically with typical GORD symptoms that resolved with PPI therapy Sensitivity Specificity PPV NPV LR+ LR– Wenner, Johnsson et al. () Department of Surgery, Lund Randomised crossover trial 35 patients (31 patients had enough data to be included) Inclusion: Patients referred for oesophageal pH monitoring Index test: System: Bravo™ wireless capsule system Insertion: transorally Sensitivity Specificity PPV NPV
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx