University Hospital, Level: II 15 males, 16 females Exclusion: Placement: 6 cm above the SCJ LR+ Lund, Sweden LR– Quality: Median age: 52 years Patients with coagulopathy, severe Duration: 48 hours oesophagitis/stricture, portal Patient selection: Median BMI: 27 (range Comparator: hypertension, a pacemaker, age 24–28) Index test: System: Slimline (Medtronic) <20 or >70 years, previous Indications: Reference Insertion: transnasally surgery, severe standard: ? Typical reflux symptoms Placement: 5 cm above the upper border of the cardiopulmonary disease, (55%) and atypical reflux Flow and timing: LOS symptoms suggestive of symptoms (45%) C1 Duration: 24 hours oesophageal motor disorders P2 Sensitivity Wenner et al. (); Diagnostic 70 patients, but 64 had Inclusion: Index test: Specificity Wenner, study enough data to be Patients: presence of typical reflux System: Bravo™ wireless capsule system LR+ Johansson et al. () included (39 males, 25 symptoms such as heartburn and Insertion: transorally LR– females) Department of regurgitation. Symptoms had to Level: III-3 Placement: 6 cm above the SCJ Surgery, Lund 55 controls (27 males occur more than twice weekly. Quality: Reference standard (for sensitivity and University Hospital, and 28 females) Treatment with medical acid Patient selection: specificity): Lund, Sweden suppression had to result in Not all patients are Clinical diagnosis: symptoms suggestive of Index test: ? complete symptom relief or a more included in the distal GORD and responding to acid suppression Reference than 50% reduction of the capsule outcomes standard: symptoms Indications: Flow and timing: ? Exclusion: Patients with typical reflux CX Coagulopathy, severe symptoms oesophagitis/stricture, portal P3 hypertension, pacemaker, <20 or >70 years of age, history of surgery, severe cardiopulmonary disease, symptoms suggestive of oesophageal motor disorders
University Hospital, Lund, Sweden Level: II Quality: Patient selection: Index test: Reference standard: ? Flow and timing: C1 P2 15 males, 16 females Median age: 52 years Median BMI: 27 (range 24–28) Indications: Typical reflux symptoms (55%) and atypical reflux symptoms (45%) Exclusion: Patients with coagulopathy, severe oesophagitis/stricture, portal hypertension, a pacemaker, age <20 or >70 years, previous surgery, severe cardiopulmonary disease, symptoms suggestive of oesophageal motor disorders Placement: 6 cm above the SCJ Duration: 48 hours Comparator: System: Slimline (Medtronic) Insertion: transnasally Placement: 5 cm above the upper border of the LOS Duration: 24 hours LR+ LR– Wenner et al. (); Wenner, Johansson et al. () Department of Surgery, Lund University Hospital, Lund, Sweden Diagnostic study Level: III-3 Quality: Patient selection: Index test: ? Reference standard: Flow and timing: ? CX P3 70 patients, but 64 had enough data to be included (39 males, 25 females) 55 controls (27 males and 28 females) Not all patients are included in the distal capsule outcomes Indications: Patients with typical reflux symptoms Inclusion: Patients: presence of typical reflux symptoms such as heartburn and regurgitation. Symptoms had to occur more than twice weekly. Treatment with medical acid suppression had to result in complete symptom relief or a more than 50% reduction of the symptoms Exclusion: Coagulopathy, severe oesophagitis/stricture, portal hypertension, pacemaker, <20 or >70 years of age, history of surgery, severe cardiopulmonary disease, symptoms suggestive of oesophageal motor disorders Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm above the SCJ Reference standard (for sensitivity and specificity): Clinical diagnosis: symptoms suggestive of GORD and responding to acid suppression Sensitivity Specificity LR+ LR–