Qualityof Life Assessment As an Outcome of Anti Reflux Therapy

Health-related quality-of-life (HRQOL) assessment is defined as the functional effect of the illness as perceived by the patient. Health-related quality-of-life assessment has been utilized in recent trials assessing GERD outcomes.76-78 There are several generic as well as disease-specific instruments that have been utilized in these studies, including the SF-36, psychological general-well-being index (PGWBI), quality of life in reflux and dyspepsia (QOLRAD), and gastrointestinal quality-of-life index (GIQLI), among others. These HRQOL endpoints, however, are subject to the individual thresholds of the patient. If these assessments are used as primary outcomes to assess GERD therapy, they are subject to the variances in the patient expectations for disease management. This may be an issue especially if there is not a control arm in the scientific design of the study. It is clear that disease severity correlates with HRQOL and does contribute to a negative effect on both work productivity and absenteeism. There are, however, cultural and situational variances in patient willingness to go to work when they do not feel well. Absenteeism thereby may not be an accurate outcome measure, in particular in the United States. Work productivity assessment may be a more reasonable measure, provided validated instruments are used to assess this accurately.

In contrast to both the surgical and endo-scopic anti-reflux trials, the recent medical trials (primarily involving the use of PPIs) have consistently utilized a GERD HRQOL instrument. Proton pump inhibitor use as a rule has consistently improved the HRQOL, although it is clear that QOL is not normalized until heartburn resolution is achieved.71,79 This correlation of QOL and symptoms is an important advance in the effort to draw corollaries between the different GERD outcomes.

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