Author(s)
Gale Harding, MA, Senior Project Manager1, Laurie Roberts, MPH, Project Manager1, Brennan MR. Spiegel, MD, MSHS, Director2, Reema R Mody, PhD, MBA, Manager3, Dennis Revicki, PhD, Director1, Peter J Kahrilas, MD, Professor, Division of Gastroenterology4, Michael L Camilleri, MD, Gastroenterology5, Kimberly Walter, RN, BSN, BA, Research Assistant11United BioSource Corporation, Bethesda, MD, USA; 2 VA Greater Los Angeles Healthcare System; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 3 TAP Pharmaceutical Products Inc, Lake Forest, IL, USA; 4 Northwestern University, Chicago, IL, USA; 5 Mayo Clinic, Rochester, MN, USA
Objective: Current GERD assessment questionnaires for adults are limited in their ability to capture nocturnal symptoms. The objective of this study was to develop and validate an instrument to assess severity and impact of nocturnal GERD symptoms. Methods: Two focus groups and 16 cognitive debriefing interviews were conducted among patients with GERD to identify key issues and concerns related to nocturnal GERD symptoms. The resulting 29-item draft instrument was included in a study of 196 patients diagnosed with GERD at 12 clinics in the United States to evaluate the psychometric properties. Assessments were conducted at baseline and at 4 weeks. Construct validity was evaluated using the Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM), Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL), number of nights with symptoms, disability days, and clinician and patient assessment of GERD severity. Exploratory factor analyses and item response theory analyses were conducted to finalize items and subscales. Results: Mean age of participants was 45 years; 76% were female and 68% were Caucasian. Patient-rated severity at baseline was mild or moderate for 69% of participants, with 48% reporting GERD-related symptoms 2-3 nights within the past week. The final questionnaire includes 20 items and consists of 3 subscales: nocturnal symptoms; morning impact; and concern regarding nocturnal GERD. The subscales demonstrated internal consistency reliability (Cronbach's alpha 0.92-0.95). The subscale scores were statistically significantly correlated with subscales of the PAGI-SYM and PAGI-QOL (0.41- 0.81; all p <0.0001), number of nights with GERD symptoms (0.45-0.54; all p <0.0001), disability days (0.19 – 0.43; all p <0.05), and clinician and patient-reported disease severity (0.46 - 0.72; all p<0.0001). Conclusion: Results support the reliability and validity of the newly developed questionnaire as a measure of severity of nocturnal GERD symptoms, morning impact, and concern related to nocturnal GERD.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PGI22
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Gastrointestinal Disorders
