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Page 1 of 9 Expression of Gastrointestinal Symptoms and Their Impact: Similarities and Differences Across Countries
Donald L. Patrick1, Catherine Acquadro2, Katrin Conway2 | | |
Keywords: irritable bowel byndrome (IBS), patient-reported outcomes (PROs), patient-reported outcomes measures (PROMs), translation, cultural adaptation
This article is based on a presentation given at: IBS - The Global Perspective, an international symposium organized jointly by the Rome Foundation and World Gastroenterology Organization in Milwaukee, Wisconsin, USA in April 2011 Introduction and objectives
Patient-reported outcomes (PROs) of gastrointestinal symptoms are important because there are no biomarkers readily
available for conditions such as irritable bowel syndrome (IBS); clinician-reports and global assessments of signs and
symptoms, if used, need augmentation with the patient perspective without clinician interpretation. The Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) have published guidance in which they advise the use of
PROs in IBS.1, 2 In addition, a variety of socio-cultural, environmental and behavioral factors are important to consider in assessing outcomes of treatment. Heterogeneity of clinical trial populations may make detection of a treatment's benefit more problematic, requiring large sample sizes to address variability. The patient perspective has been used extensively within gastroenterology in inflammatory bowel disease and functional bowel disorders3-7 and these measures are used widely in global clinical trials.8
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