A reliable, accurate, noninvasive method for identifying patients with GERD in the primary care setting is needed. A population-screening instrument may assist managed care organizations and clinicians to identify candidates for disease management, or quality improvement programs. OBJECTIVE: To develop and validate a GERD screening instrument. METHODS: A screening instrument containing 10 questions was developed based on literature review and expert opinion. Categorical and continuous scoring methods with and without medication use were identified a priori. Using telephone interview in a medical group, we identified and enrolled 100 subjects with a history of GERD-like symptoms and 100 controls. Each subject completed the screening instrument, a validated gastrointestinal symptom questionnaire (DHSI), and was evaluated independently by 2 gastroenterologists using a structured format. The gold standard was defined as patients who required an intervention and who had physician agreement that their symptoms were consistent with GERD. RESULTS: 70 subjects were classified as GERD using the gold standard (kappa = 0.79). Using a continuous measure of GERD symptoms, including frequency, severity, and type of medication use as the scoring method (total score range 0-29), an area under the receiver operator characteristic curve (ROC) of 0.89 (95% CI 0.84-0.94) was observed. Using a cutoff of > 9 points, this measure is 83% sensitive and 82% specific. Using a cutoff of > 12 points, this measure is 65% sensitive and 92% specific. Compared to the gold standard, the DHSI GERD subscale has an ROC of 0.89 (95% CI 0.84-0.94). The screening instrument was highly correlated with the DHSI GERD subscale, r = 0.74 (95% CI 0.67-0.80; p<0.0001). CONCLUSIONS: The screening instrument appears to have construct, convergent and predictive validity. It is shorter than existing validated instruments, practical and easily administered. This may serve as a valuable case-finding instrument in primary care and managed care organizations.