Determination of ReQuest-based symptom thresholds to define symptom relief in GERD clinical studies.
OBJECTIVE
The growing importance of symptom assessment is evident from the numerous clinical studies on gastroesophageal reflux disease (GERD) assessing treatment-induced symptom relief. However, to date, the a priori selection of criteria defining symptom relief has been arbitrary. The present study was designed to prospectively identify GERD symptom thresholds for the broad spectrum of GERD-related symptoms assessed by the validated reflux questionnaire (ReQuest) and its subscales, ReQuest-GI (gastrointestinal symptoms) and ReQuest-WSO (general well-being, sleep disturbances, other complaints), in individuals without evidence of GERD.


METHODS
In this 4-day evaluation in Germany, 385 individuals without evidence of GERD were included. On the first day, participants completed the ReQuest, the Gastrointestinal Symptom Rating Scale, and the Psychological General Well-Being scale. On the other days, participants filled in the ReQuest only. GERD symptom thresholds were calculated for ReQuest and its subscales, based on the respective 90th percentiles.


RESULTS
GERD symptom thresholds were 3.37 for ReQuest, 0.95 for ReQuest-GI, and 2.46 for ReQuest-WSO.


CONCLUSIONS
Even individuals without evidence of GERD may experience some mild symptoms that are commonly ascribed to GERD. GERD symptom thresholds derived in this study can be used to define the global symptom relief in patients with GERD.
Stanghellini
Vincenzo
V
S. Orsola-Malpighi University Hospital, Bologna, Italy. v.stanghellini@unibo.it
Armstrong
David
D
Mönnikes
Hubert
H
Berghöfer
Peter
P
Gatz
Gudrun
G
Bardhan
Karna Dev
KD
D000328:Adult; D000367:Age Factors; D002986:Clinical Trials as Topic; D016001:Confidence Intervals; D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis*; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D017288:Pain Threshold; D011788:Quality of Life; D012016:Reference Values; D015203:Reproducibility of Results; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D011795:Surveys and Questionnaires / Q000592:standards*