BACKGROUND: To date, no patient reported outcomes (PRO) instrument is available for evaluation of treatment efficacy in functional dyspepsia (FD)/postprandial distress syndrome (PDS). The aim of our study was to perform focus group interviews for the development of a new questionnaire for assessing symptom pattern and severity in PDS. METHODS: Random ambulatory patients diagnosed with FD/PDS based on Rome III criteria and no predominant gastro-esophageal reflux disease (GERD) 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 PRO instrument were drafted and evaluated in cognitive interviews for relevance, clarity, and consistency. KEY RESULTS: Of 225 screened patients, 26 patients were diagnosed with PDS without overlapping GERD as single final diagnosis. Fifteen of these (87% female, 48 ± 3.2 years) 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-gastroduodenal symptoms that patients reported included heartburn (33%, but mostly sporadic), weight loss (93%, on average 5.0 ± 1.7 kg), and fatigue (67%). Questions evaluating these symptoms were validated in 15 cognitive interviews. CONCLUSIONS & INFERENCES: This focus group study confirms symptoms corresponding to postprandial fullness and early satiation as the key items for developing a PRO for PDS.
BACKGROUND: To date, no patient reported outcomes (PRO) instrument is available for evaluation of treatment efficacy in functional dyspepsia (FD)/postprandial distress syndrome (PDS). The aim of our study was to perform focus group interviews for the development of a new questionnaire for assessing symptom pattern and severity in PDS. METHODS: Random ambulatory patients diagnosed with FD/PDS based on Rome III criteria and no predominant gastro-esophageal reflux disease (GERD) 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 PRO instrument were drafted and evaluated in cognitive interviews for relevance, clarity, and consistency. KEY RESULTS: Of 225 screened patients, 26 patients were diagnosed with PDS without overlapping GERD as single final diagnosis. Fifteen of these (87% female, 48 ± 3.2 years) 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-gastroduodenal symptoms that patients reported included heartburn (33%, but mostly sporadic), weight loss (93%, on average 5.0 ± 1.7 kg), and fatigue (67%). Questions evaluating these symptoms were validated in 15 cognitive interviews. CONCLUSIONS & INFERENCES: This focus group study confirms symptoms corresponding to postprandial fullness and early satiation as the key items for developing a PRO for PDS.
Authors: Fiona Taylor; Sophie Higgins; Robyn T Carson; Sonya Eremenco; Catherine Foley; Brian E Lacy; Henry P Parkman; David S Reasner; Alan L Shields; Jan Tack; Nicholas J Talley Journal: Am J Gastroenterol Date: 2017-09-19 Impact factor: 10.864
Authors: Dorien Beeckmans; Danny Riethorst; Patrick Augustijns; Tim Vanuytsel; Ricard Farré; Jan Tack; Hanne Vanheel Journal: United European Gastroenterol J Date: 2018-09-04 Impact factor: 4.623
Authors: Robert C Heading; Edward C M Thomas; Phil Sandy; Gary Smith; Ronnie Fass; Pali S Hungin Journal: Eur J Gastroenterol Hepatol Date: 2016-04 Impact factor: 2.566
Authors: Nunzio Ranaldo; Giuseppe Losurdo; Andrea Iannone; Mariabeatrice Principi; Michele Barone; Massimo De Carne; Enzo Ierardi; Alfredo Di Leo Journal: Cell Death Dis Date: 2017-09-07 Impact factor: 8.469