The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux questionnaire.
BACKGROUND
This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS.


METHODS
Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD. The final measure consisted of 31 items covering 7 categories (Heartburn; Acid reflux; Wind; Eating and swallowing; Bowel movements; Sleep; Work, physical and social activities). The measure produced two outputs: a quality of life score (RQLS) and five Reflux symptom scores. Reliability (internal consistency), criterion validity with the SF-36 and, sensitivity to change in terms of relationship with reported change in prescribed medication were assessed amongst a sample of 794 patients recruited into the trial.


RESULTS
The measure was shown to be internally consistent, to show criterion validity with the SF-36 and sensitive to changes in patients use of prescribed medication at baseline and 3 month follow-up.


CONCLUSIONS
The Reflux questionnaire is a new self-administered questionnaire for use amongst patients with GORD. Initial findings suggest that the new measure is valid, reliable, acceptable to respondents and simple to administer in both a clinical and research context.
Macran
Susan
S
Outcomes Research Group, Centre for Health Economics, University of York, Heslington, York, YO10 5DD, United Kingdom. sm37@york.ac.uk
Wileman
Samantha
S
Barton
Garry
G
Russell
Ian
I
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D005764:Gastroesophageal Reflux / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012649:Self Concept; D011795:Surveys and Questionnaires; D006113:United Kingdom