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- W2010808520 abstract "INTRODUCTION The assessment of treatment response in CC trials has historically focused on bowel symptoms; however, the FDA guidance on patient reported outcome (PRO) measures recommends that selection of appropriate endpoints for clinical trials be based upon direct patient input obtained through open-ended patient interviews or focus groups. AIMS and METHODS The study aimed to identify a comprehensive set of CC symptoms important to patients and optimal terminology to measure those symptoms. Twenty-eight in-depth qualitative interviews were conducted in two geographic locations in patients meeting modified Rome II criteria for CC. A semi-structured interview guide was used, beginning with a series of open-ended questions to ascertain all relevant symptoms. Participants were subsequently probed to identify their most bothersome CC symptoms as well as other symptoms not mentioned spontaneously. RESULTS Patients spontaneously reported bowel symptoms including infrequent stools (28/28), hard stools (22/28) straining (20/28), unsuccessful attempts to have a BM (18/28), stools too small or too large (18/28), and incomplete BMs (13/28). In addition, patients frequently reported abdominal symptoms including bloating (22/28), abdominal pain (22/28), abdominal discomfort (15/28), stomach pains/aches (14/28), abdominal cramping (13/28), and feeling of fullness/feeling stuffed (13/ 28). Other symptoms elicited were predominantly the consequence of severe bowel or abdominal symptoms. For example, patients reported rectal pain, hemorrhoids, and rectal bleeding secondary to straining and hard stools. The symptoms reported most frequently by patients as their most bothersome included bloating, rectal pain, infrequent BMs, and abdominal pain. CONCLUSIONS This study is the first published report of symptoms spontaneously identified by CC patients through open-ended interviews using the methods outlined in FDA's guidance on PROs. Although patients identified a wide variety of symptoms, symptom assessment in a clinical trial should be focused on the most relevant symptoms reported by patients. These interview results suggest that in addition to bowel symptoms, abdominal symptoms are important and bothersome to CC patients and should be considered for inclusion in the assessment of treatment response in CC clinical trials." @default.
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- W2010808520 date "2010-05-01" @default.
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- W2010808520 title "M1346 High Prevalence of Lower Gastrointestinal (GI) Symptoms in Functional Dyspepsia: A Factor and Cluster Analysis in the General Population" @default.
- W2010808520 doi "https://doi.org/10.1016/s0016-5085(10)61770-2" @default.
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