Endpoints for the assessment of response to gastroesophageal reflux disease therapy--what are the appropriate measures of "success"?
Therapeutic efficacy for gastroesophageal reflux disease (GERD) has been justified by a variety of different endpoints. Across the surgical, endoscopic, and pharmacologic treatment interventions, an attempt has been made to justify the success of the effect by objective and subjective means. This has included objective measures of esophageal sphincter pressure, intraesophageal acid exposure, and endoscopic esophagitis. More subjective measures have included symptom response as determined by questionnaires, severity scales, physician assessment, and quality-of-life impact. Despite the innumerable studies reporting various treatment interventions for GERD, overall there is a general lack of a standardized methodology to allow comparison of the relative success achieved among various methodologies. Furthermore, there is a striking lack of use of validated instruments to accurately assess treatment effect in many of these studies. This review focuses on the questions that should be raised by clinicians in their evidence-based evaluation of the outcomes achieved in these GERD intervention trials.
Johnson
David A
DA
Division of Gastroenterology, Eastern Virginia Medical School, Norfolk, Virginia, USA.
D016099:Endoscopy, Gastrointestinal; D004947:Esophagus / Q000503:physiopathology; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D017063:Outcome Assessment, Health Care; D010528:Peristalsis; D011788:Quality of Life; D015203:Reproducibility of Results