Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders.
OBJECTIVE
The Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) has been developed and validated to assess quality of life in gastroesophageal reflux disease, dyspepsia, and gastroparesis. The aim of this work was to assess responsiveness of the PAGI-QOL to clinical changes and provide guidance for the interpretation of score changes.


METHODS
The analysis was based on 2 observational multicenter, longitudinal, 8-week observation studies, one in the United States and one in 5 European countries. The Overall Treatment Effect scale completed by patients and clinicians at 8 weeks was used to define groups of improved, worsened, and stable patients. Responsiveness was assessed by describing the change in PAGI-QOL scores for each of these groups, comparing these changes over time, and calculating effect sizes and standardized response means. These data were used to define the minimal clinically important difference.


RESULTS
A total of 1736 patients with upper gastrointestinal disorders were analyzed. High sensitivity to change over time was demonstrated, with effect sizes and standardized response means in improved patients for the PAGI-QOL total score ranging from 0.79-1.41. A change of 0.4 for the PAGI-QOL total score might be considered as the minimal clinically important difference when comparing pretreatment and post-treatment PAGI-QOL total scores.


CONCLUSIONS
The PAGI-QOL questionnaire is a responsive and clinically relevant instrument for assessing quality of life in patients with upper gastrointestinal disorders.
De La Loge
Christine
C
Mapi Values, Lyon, France.
Trudeau
Elyse
E
Marquis
Patrick
P
Revicki
Dennis A
DA
Rentz
Anne M
AM
Stanghellini
Vincenzo
V
Talley
Nicholas J
NJ
Kahrilas
Peter
P
Tack
Jan
J
Dubois
Dominique
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005247:Feeding Behavior; D005260:Female; D005764:Gastroesophageal Reflux / Q000523:psychology* / Q000628:therapy; D018589:Gastroparesis / Q000523:psychology* / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D011795:Surveys and Questionnaires