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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.

Hypothesis Obesity impairs the antireflux function of a structurally intact barrier. Design Retrospective analysis of body mass index in patients with normal esophageal manometric findings but with symptomatic and objectively confirmed gastroesophageal reflux. Setting Specialist esophageal center. Patients Patients symptomatic and diagnostic for gastroesophageal reflux, referred between October 1, 1998, and June 30, 2000. Exclusion criteria were a defective barrier, motility disorders, or previous surgery. Main Outcome Measures Reflux was defined and quantified using the DeMeester score, and body mass index was calculated. Results There was a strong correlation between body mass index and severity of gastroesophageal reflux. Patients who were overweight had significantly higher distal esophageal acid exposure. No significant difference in manometric findings was demonstrated between patients with normal weight and those who were overweight. Conclusion The barrier to gastroesophageal reflux is rendered insufficient in patients who are overweight.

Recent studies have shown that many patients use acid suppression medications after antireflux surgery. The aim of this study was to determine the frequency of gastroesophageal reflux disease in a cohort of surgically treated patients with postoperative symptoms and a high prevalence of acid suppression medication use. The study group consisted of 86 patients who had symptoms following Nissen fundoplication that were sufficient to merit evaluation with 24-hour distal esophageal pH monitoring. All completed a detailed symptom questionnaire. The mean postoperative follow-up period was 28 months (median 18 months). Thirty-seven patients (43%) were taking acid suppression medications after fundoplication. Only 23% (20 of 86) of all the patients and only 24% (9 of 37) of those taking acid suppression medications had abnormal esophageal acid exposure on the 24-hour pH study. Heartburn and regurgitation were the only symptoms that were significantly associated with an abnormal pH study. Endoscopic assessment of the fundoplication was the most significant factor associated with an abnormal pH study. Multivariable logistic regression analysis showed that patients with a disrupted, abnormally positioned fundoplication had a 52.6 times increased risk of abnormal esophageal acid exposure. Most patients who use acid suppression medications after antireflux surgery do not have abnormal esophageal acid exposure, and the use of these medications is thus often inappropriate. Because of the limited predictive power of symptoms, objective evidence of reflux disease should be obtained before prescribing acid suppression medication for patients who have undergone antireflux surgery.