The development and validation of a Nocturnal Gastro‐oesophageal Reflux Disease Symptom Severity and Impact Questionnaire for adults

• Published in: Alimentary pharmacology & therapeutics Vol. 32; no. 4; pp. 591 - 602
• Main Authors: Spiegel, B. M., Roberts, L., Mody, R., Harding, G., Kothari‐Talwar, S., Kahrilas, P. J., Camilleri, M. L., Dabbous, O., Revicki, D. A.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-08-2010; Blackwell
• Subjects: Adult; Aged; Biological and medical sciences; Circadian Rhythm; Digestive system; Esophagus; Factor Analysis, Statistical; Female; Focus Groups; Gastroenterology. Liver. Pancreas. Abdomen; Gastroesophageal Reflux - diagnosis; Gastroesophageal Reflux - psychology; Humans; Longitudinal Studies; Male; Medical sciences; Middle Aged; Other diseases. Semiology; Pharmacology. Drug treatments; Psychometrics; Quality of Life; Reproducibility of Results; Severity of Illness Index; Sleep Wake Disorders - diagnosis; Sleep Wake Disorders - etiology; Sleep Wake Disorders - psychology; Surveys and Questionnaires - standards; Human; Gastroesophageal reflux; Validation; Symptomatology; Questionnaire; Esophageal disease; Development; Phenotype variation; Digestive diseases; Adult
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2010.04385.x

Aliment Pharmacol Ther 2010; 32: 591–602
Summary
Background  Current questionnaires for assessing gastro‐oesophageal reflux disease (GERD) symptoms are limited in their ability to capture nocturnal symptoms.
Aim  To develop and validate an instrument, the Nocturnal Gastro‐oesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N‐GSSIQ), to assess severity and impact of nocturnal GERD symptoms.
Methods  Two focus groups and 16 cognitive debriefing interviews were conducted among GERD patients to identify key issues about nocturnal symptoms. A draft instrument was tested in 196 patients at 11 clinics in the US to evaluate psychometric properties. Exploratory factor and item response theory analyses were conducted to finalize items and subscales. Internal consistency reliability, reproducibility and construct validity were examined.
Results  Mean age was 45 (s.d. = 13.8) years; 76% were female and 68% were Caucasian. Patient‐rated severity was mild–moderate for 69% of participants; 48% reported symptoms on two to three nights the past week. The final questionnaire includes 20 items and three subscales: Nocturnal GERD Symptoms, Morning Impact of Nocturnal GERD and Concern about Nocturnal GERD. The subscales demonstrated internal consistency reliability (Cronbach’s alpha 0.84–0.94) and were significantly correlated with similar measures and disease severity (0.41–0.81; P < 0.0001).
Conclusion  The results support the reliability and validity of the N‐GSSIQ as a measure of severity, morning impact and concern about nocturnal GERD.