{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T13:56:14Z","timestamp":1790517374393,"version":"4.1.0"},"reference-count":44,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2014,7,29]],"date-time":"2014-07-29T00:00:00Z","timestamp":1406592000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Leuven University","award":["Methusalem Grant"],"award-info":[{"award-number":["Methusalem Grant"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      To date, no patient reported outcomes (\n                      <jats:styled-content style=\"fixed-case\">PRO<\/jats:styled-content>\n                      ) instrument is available for evaluation of treatment efficacy in functional dyspepsia (\n                      <jats:styled-content style=\"fixed-case\">FD<\/jats:styled-content>\n                      )\/postprandial distress syndrome (\n                      <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content>\n                      ). The\n                      <jats:italic>aim<\/jats:italic>\n                      of our study was to perform focus group interviews for the development of a new questionnaire for assessing symptom pattern and severity in\n                      <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Random ambulatory patients diagnosed with\n                      <jats:styled-content style=\"fixed-case\">FD<\/jats:styled-content>\n                      \/\n                      <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content>\n                      based on\n                      <jats:styled-content style=\"fixed-case\">R<\/jats:styled-content>\n                      ome III criteria and no predominant gastro\u2010esophageal reflux disease (\n                      <jats:styled-content style=\"fixed-case\">GERD<\/jats:styled-content>\n                      ) symptoms were invited to participate. Focus group sessions were organized where patients reported and discussed their symptoms, facilitated by an experienced physician. After reaching saturation of identified symptom items, questions for a pilot\n                      <jats:styled-content style=\"fixed-case\">PRO<\/jats:styled-content>\n                      instrument were drafted and evaluated in cognitive interviews for relevance, clarity, and consistency.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Key Results<\/jats:title>\n                    <jats:p>\n                      Of 225 screened patients, 26 patients were diagnosed with\n                      <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content>\n                      without overlapping\n                      <jats:styled-content style=\"fixed-case\">GERD<\/jats:styled-content>\n                      as single final diagnosis. Fifteen of these (87% female, 48\u00a0\u00b1\u00a03.2\u00a0years) participated in one of three focus groups. All (100%) confirmed experiencing symptoms that were triggered or aggravated by ingestion of a meal, corresponding to early satiation (100%), and postprandial fullness (100%). In addition reported gastroduodenal symptoms were nausea (40%, postprandial in all, interprandial in 20%), upper abdominal bloating (33%), excessive belching (27%), and vomiting (13%). Epigastric pain and burning were present in respectively 20% and 13%. Non\u2010gastroduodenal symptoms that patients reported included heartburn (33%, but mostly sporadic), weight loss (93%, on average 5.0\u00a0\u00b1\u00a01.7\u00a0kg), and fatigue (67%). Questions evaluating these symptoms were validated in 15 cognitive interviews.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions &amp; Inferences<\/jats:title>\n                    <jats:p>\n                      This focus group study confirms symptoms corresponding to postprandial fullness and early satiation as the key items for developing a\n                      <jats:styled-content style=\"fixed-case\">PRO<\/jats:styled-content>\n                      for\n                      <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/nmo.12381","type":"journal-article","created":{"date-parts":[[2014,7,29]],"date-time":"2014-07-29T22:45:49Z","timestamp":1406673949000},"page":"1266-1274","source":"Crossref","is-referenced-by-count":26,"title":["Functional dyspepsia: outcome of focus groups for the development of a questionnaire for symptom assessment in patients suffering from postprandial distress syndrome (PDS)"],"prefix":"10.1111","volume":"26","author":[{"given":"F.","family":"Carbone","sequence":"first","affiliation":[{"name":"KU Leuven TARGID Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Holvoet","sequence":"additional","affiliation":[{"name":"University of Leuven Translational Research Center for Gastrointestinal Disorders (TARGID) Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Vandenberghe","sequence":"additional","affiliation":[{"name":"MRC Chaumont\u2010Gistoux Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Tack","sequence":"additional","affiliation":[{"name":"University of Leuven Translational Research Center for Gastrointestinal Disorders (TARGID) Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,7,29]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.059"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.05.030"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.66"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-301454"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2982.2009.01261.x"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa052639"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2003.01575.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.coph.2008.09.009"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2007.132449"},{"key":"e_1_2_8_11_1","first-page":"1906","article-title":"Tegaserod treatment for dysmotility\u2010like functional dyspepsia: results of two randomized, controlled trials","volume":"103","author":"Vakil N","year":"2008","journal-title":"Am J Gastroenterol"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2010.04566.x"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-4-79"},{"key":"e_1_2_8_14_1","unstructured":"U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research;U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research;U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health.Guidance for industry: patient\u2010reported outcome measures: use in medical product development to support labeling claims.2009. 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