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Objective To evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements “QRI actions” to address these as recruitment proceeds. Study Design and Setting A mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) qualitative case studies, including documentary analysis and interviews with RCT investigators. Results Five UK-based publicly funded RCTs were included in the evaluation. All recruited to target. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI actions in RCTs 1, 3, 4, and 5. Randomization rates significantly improved after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action. Conclusion There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.

Background & Aims The Bravo pH capsule is a catheter-free intraesophageal pH monitoring system that avoids the discomfort of an indwelling catheter. The objectives of this study were as follows: (1) to obtain normal values for the first and second 24-hour recording periods using a Bravo capsule placed transnasally 5 cm above the upper border of the lower esophageal sphincter determined by manometry and to assess concordance between the 2 periods, (2) to determine the optimal discriminating threshold for identifying patients with gastroesophageal reflux disease (GERD), and (3) to validate this threshold and to identify the recording period with the greatest accuracy. Methods Normal values for a manometrically positioned, transnasally inserted Bravo capsule were determined in 50 asymptomatic subjects. A test population of 50 subjects (25 asymptomatic, 25 with GERD) then was monitored to determine the best discriminating thresholds. The thresholds for the first, second, and combined (48-hour) recording periods then were validated in a separate group of 115 patients. Results In asymptomatic subjects, the values measured using a manometrically positioned Bravo pH capsule were similar between the first and second 24-hour periods of recording. The highest level of accuracy with Bravo was observed when an abnormal composite pH score was obtained in the first or second 24-hour period of monitoring. Conclusions Normal values for esophageal acid exposure were defined for a manometrically positioned, transnasally inserted, Bravo pH capsule. An abnormal composite pH score, obtained in either the first or second 24-hour recording period, was the most accurate method of identifying patients with GERD.

The incidence of gastroesophageal reflux disease (GERD) is increasing and if left untreated can lead to significant patient morbidity and even death. The disease results from the abnormal reflux of gastric contents into the distal esophagus causing symptoms in most and subsequent mucosal damage in some. Several investigations can be used to confirm the diagnosis, but most are dependent on the presence of sequelae and complications of the disease. The physiologic test of ambulatory 24-hour esophageal pH monitoring has proved to be the most sensitive and specific diagnostic investigation. It measures increased esophageal exposure to gastric juice by detecting the concentration of hydrogen ions (pH

Background Quality of life, poor in patients with reflux disease, improves significantly after an antireflux operation. The aim of this study was to determine the relative importance of the operative approach used for a fundoplication, as well as the successful elimination of reflux symptoms on long-term quality of life in patients with gastroesophageal reflux disease. Methods A questionnaire, including the medical outcome study short-form health survey (SF-36), was completed by 105 patients who had undergone either a laparoscopic Nissen fundoplication (n = 72) or a transthoracic Nissen fundoplication (n = 33); median follow-up was 25 and 31 months, respectively. Patients were classified as completely or incompletely relieved of reflux symptoms based on the frequency of reflux symptoms and the use of acid-suppression medication. Results Patients selected for transthoracic Nissen fundoplication had significantly worse preoperative gastroesophageal reflux disease based on the presence of a large hiatal hernia, Barrett's esophagus, or stricture. Long-term quality of life was similar for the two approaches, but was significantly decreased in patients with recurrent reflux symptoms. Compared with laparoscopic Nissen fundoplication patients, transthoracic Nissen fundoplication patients were less likely to use acid-suppression medication and tended to be more satisfied with their operation. Conclusions Long-term quality of life was independent of the invasiveness of the procedure, but significantly dependent on successful elimination of reflux symptoms and the necessity for acid suppression medication. Patients who underwent a transthoracic Nissen fundoplication, despite having more advanced disease preoperatively, tended to have less reflux symptoms and less long-term acid-suppression medication usage after their procedure. These findings support the continued use of a transthoracic antireflux procedure in patients with advanced gastroesophageal reflux disease.