Development and validation of a disease-specific quality of life questionnaire for gastro-oesophageal reflux disease: the GERD-QOL questionnaire.
BACKGROUND
A simple and meaningful health-related quality of life (HRQoL) questionnaire for gastro-oesophageal reflux disease (GERD) patients is lacking.


OBJECTIVE
To develop and validate a disease-specific HRQoL instrument (GERD-QOL) for GERD patients.


METHODS
An 18-item questionnaire was generated to measure the impact of GERD on sleep, exercise, diet, need for medication, sex life, work, social activity and psychological well-being. GERD patients were invited to complete the GERD-QOL, a visual analogue scale (VAS) and a validated Chinese generic QoL (SF-36) questionnaire before and after esomeprazole treatment. Factor analysis was performed for item selection and psychometric properties were measured. An English version was developed by a forward-backward translation process.


RESULTS
A final 16-item GERD-QOL questionnaire was developed. The items were grouped into four subscales (Daily activity, Treatment effect, Diet, and Psychological well-being) after factor analysis. GERD-QOL had good item-internal consistency (Cronbach's alpha: 0.64-0.88), high test-retest reliability (intraclass correlation coefficient: 0.73-0.94, P < 0.001). Its subscale scores were correlated with SF-36 and VAS, which demonstrated high construct validity (P < 0.001). Discriminant validity was verified by correlating GERD-QOL scores with symptom severity (P < 0.001). Responsiveness after esomeprazole treatment was significant (paired-t-test P < 0.001). An English version of GERD-QOL was developed.


CONCLUSIONS
The instrument, GERD-QOL, is valid and reliable.
Chan
Y
Y
Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.
Ching
J Y L
JY
Cheung
C M Y
CM
Tsoi
K K F
KK
Polder-Verkiel
S
S
Pang
S H Y
SH
Quan
W L
WL
Kee
K M
KM
Chan
F K L
FK
Sung
J J Y
JJ
Wu
J C Y
JC
D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life / Q000523:psychology*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires / Q000592:standards*