Systematic review: health-related quality of life (HRQOL) questionnaires in gastro-oesophageal reflux disease.
BACKGROUND
Although gastro-oesophageal reflux disease (GERD) has a well-established pathophysiology, the impact of GERD symptoms on the patients' quality of life can be profound. Therefore, health-related quality of life (HRQOL) questionnaires have become standard instruments to evaluate the effect of treatment in clinical trials.


OBJECTIVE
To evaluate the reliability, validity and responsiveness of available GERD-specific HRQOL.


METHODS
A systematic literature search using the Medical Subject Headings terms: 'Gastro-oesophageal reflux', 'Heartburn' and 'Oesophagitis' with 'quality of life' and 'questionnaires' was preformed to identify the available HRQOL questionnaires. To analyse the psychometric properties of the respective tools, the actual guidelines for the use of patient-reported outcomes in clinical trials were applied.


RESULTS
We identified five GERD-specific HRQOL questionnaires but none of them fulfilled all quality criteria; either they did not meet the actual standards for psychometric properties (HBQOL, GERD-HRQL, Jasani et al.Aust Fam Physician 1999; 28: 515), or were impracticable to use in clinical trials. The generic and hybrid instruments lack specificity and sensitivity and were not designed for treatment evaluation in GERD patients.


CONCLUSIONS
There is need for a new evaluative tool in the assessment of HRQOL during GERD therapy.
Chassany
O
O
Département de Recherche Clinique et du développement, Assistance Publique - Hôpitaux de Paris, Hôpital Saint-Louis, Paris, France. olivier.chassany@sls.aphp.fr
Holtmann
G
G
Malagelada
J
J
Gebauer
U
U
Doerfler
H
H
Devault
K
K
D002986:Clinical Trials as Topic; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000523:psychology*; D006801:Humans; D011594:Psychometrics; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires / Q000592:standards*