There are problems with the definition, assessment, and measurement of gastroesophageal reflux disease (GERD). The Reflux Disease Questionnaire and the GERD questionnaire are patient-reported outcome (PRO) measures for use in a primary care setting, which are easy to use and are validated. There is no widely accepted definition of a proton pump inhibitor test and performance of the test in the clinical setting is not standardized. The use of the PRO measures in primary care with predetermined cutoff values may help to reduce the cost of diagnosing GERD and increasing rates of response for evaluated patients to acid suppression.
Key points
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The symptoms of heartburn and regurgitation may be sensitive but are not adequately specific for diagnosing or excluding gastroesophageal reflux disease (GERD).
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Symptom assessment, particularly from a patient’s perspective, is important and tools for measuring these are validated.
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The poorly defined but popular proton pump inhibitor (PPI) test is neither sensitive nor specific enough for diagnosing/excluding GERD.
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The use of the GERD outcomes measures (Reflux Disease Questionnaire and GERD Questionnaire) may be helpful in identifying patients in primary care for whom a PPI test may be cost-effective.
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These measures may be best used as components of a clinical pathway/algorithm for GERD diagnosis/evaluation.
Heartburn and regurgitation are the most common symptoms of gastroesophageal reflux disease (GERD) and are widely accepted as the classic symptoms. Heartburn is most commonly defined as a burning, retrosternal, painful sensation of short duration associated with a meal and regurgitation is defined as the retrograde flow of presumed gastric contents or a sensation of bitter contents in the mouth without associated nausea or retching. In clinical practice, the meaning of heartburn is not standardized and well communicated. In a group of 129 patients from Boston, Spechler and colleagues reported that the term heartburn was understood by only 34.6%, 53.8%, and 13.2% of white people, black people, and East Asian people, respectively. In the same study, among patients who claimed that they had heartburn, 29.7% did not describe symptoms that a reasonable clinician would define as heartburn. In contrast, 22.8% of patients who denied having heartburn experienced symptoms that physicians might consider to be heartburn. Sharma and colleagues recommended that both language and cultural barriers be considered in the evaluation and treatment of patients with GERD.
Symptom assessment
The accurate assessment of symptoms in GERD is of prime importance. Symptom assessment is the means by which a primary care provider or a gastroenterologist makes the initial diagnosis, assesses the severity of disease, formulates a diagnostic work-up, starts treatment if appropriate, and later assesses the response to treatment.
Symptom assessment
The accurate assessment of symptoms in GERD is of prime importance. Symptom assessment is the means by which a primary care provider or a gastroenterologist makes the initial diagnosis, assesses the severity of disease, formulates a diagnostic work-up, starts treatment if appropriate, and later assesses the response to treatment.
Issues in GERD symptom assessment
A significant issue in dealing with GERD symptom assessment is the lack of correlation between the severity of heartburn and the degree of acid exposure or mucosal damage. GERD symptoms are the main causes of morbidity and negatively affect quality of life, with little additional impact of endoscopic findings such as erosions or Barrett esophagus. There are gender differences among patients with GERD symptoms. These symptom differences have been described and there is evidence to show that the symptom severity in women is significantly greater than in men ( Fig. 1 ). This finding may account for GERD-related complications being more common in men, possibly because of lesser sensitivity to gastroesophageal reflux. There is a disparity in the assessment of GERD symptoms from the patient and physician perspectives, particularly before treatment initiation and for more severe symptoms.
Evaluation of symptoms in GERD
Based on data collected during a workshop in 2002 centered on symptom evaluation in reflux disease, impairment in quality of life is significant for patients who have heartburn symptoms occurring on more than 1 day of the week and whose heartburn is of moderate or greater severity.
Patient-reported outcomes in GERD symptom assessment
In order to standardize the criteria for patient selection and evaluate response to therapy, several symptom-based GERD questionnaires (GERDQs) have been proposed, studied, and validated. There has been a shift toward patient-reported outcomes (PRO); these instruments assess disease severity from a patient’s perspective.
To ensure the validity of such questionnaires, the US Food and Drug Administration (FDA) stipulated that these so-called PRO measures must have certain properties: content validity (evidence that the instrument measures what it is intended to measure), construct validity (evidence of a logical relationship between items, domains, and concepts), internal consistency (intercorrelation of items that contribute to a score), test-retest reliability (stability of scores over time when no change is expected in the concept of interest), and ability to detect change (evidence that the PRO can detect differences in scores over time when changes in the measured variable have occurred). In another systematic review for PROs measures in GERD, Vakil and colleagues reported that there are 5 instruments (GERD Symptom Assessment Scale, Nocturnal GERD Symptom Severity and Impact Questionnaire, Proton Pump Acid Suppression Symptom Test, Reflux Disease Questionnaire [RDQ], and Reflux Questionnaire) that include most steps recommended by the FDA and European Medicines Agency, and have been used as end point measures in clinical trials. In 2012 a systematic review by Chassany and colleagues reported on the considerable heterogeneity in the methodology used to develop PRO instruments for upper gastrointestinal disease. The investigators identified 10 studies (out of an initial 94 studies before exclusion criteria were applied) reporting a symptom scale PRO instrument for GERD or dyspepsia.
Among these self-administered PRO questionnaires, the RDQ is a practical and easily administered instrument targeted for use in a primary care setting. This questionnaire was used recently in the Diamond study to evaluate a cohort of patients presenting to primary care physicians in Europe and Canada. This study was based on 73 family practice clinics during which an RDQ was administered to patients after recruitment into the study during the first visit. The patients were placed on daily placebo before an endoscopy and 48-hour esophageal wireless pH probe study. The patients were then started on esomeprazole 40 mg daily for 14 ± 3 days ( Fig. 2 ). Of the 308 evaluable patients, 203 patients (65.9%) were diagnosed with GERD from reflux esophagitis by endoscopy and/or a positive 48-hour wireless esophageal pH study. The prevalence of heartburn and regurgitation as the most common symptom in patients with GERD is 49.3% versus 25.5% in patients without GERD. The prevalence of heartburn and regurgitation as the second most common symptoms in patients with GERD is 41.8% versus 21% in patients without GERD.
The RDQ includes 12 items in which 6 symptom descriptors covering 3 symptom domains, consisting of heartburn, regurgitation, and dyspepsia (upper abdominal pain and burning), are assessed separately for their frequency and severity in the previous 7 days, using a 6-point Liker scale As shown in Table 1 , a score of 0 is assigned to the first column, a score of 1 for the second column, and so forth. A maximum of 5 points is assigned for the most severe and frequent symptom designation. Based on receiver operating characteristic (ROC) curve for best-performing prespecified scoring method, the investigators of the Diamond study assigned negative value to responses on dyspepsia (“a burning feeling in the center of the upper stomach” and “a pain in the center of the upper stomach”). The RDQ scores range from 0 to a maximum of 30. A diagnosis of GERD based on a reflux esophagitis or a positive 48-hour wireless esophageal pH study are found in 77% of patients with an RDQ total of 15 to 19, and in 88% of patients with an RDQ total of 20 to 30 ( Fig. 3 ).
Another PRO questionnaire is the GERDQ, which is also designed for patients seen in the primary care setting and is the most recently developed and validated PRO measure. This instrument has 6 questions ( Table 2 ). The basis for this PRO is the data gathered from the Diamond study. The GERDQ questions are derived from the RDQ, the Gastrointestinal Symptom Rating Scale (GSRS), and the Gastroesophageal Reflux Disease Impact Scale (GIS).
| Symptoms in the Previous Week | Symptom Presence | ||||
|---|---|---|---|---|---|
| 0 d | 1 d | 2–3 d | 4–7 d | ||
| Question: | |||||
| 1 | How often did you have a burning feeling behind your breastbone (heartburn)? | 0 | 1 | 2 | 3 |
| 2 | How often did you have stomach contents (liquid or food) moving upwards to your throat or mouth (regurgitation)? | 0 | 1 | 2 | 3 |
| 3 | How often did you have a pain in the center of the upper stomach? | 3 | 2 | 1 | 0 |
| 4 | How often did you have nausea? | 3 | 2 | 1 | 0 |
| 5 | How often did you have difficulty getting a good night’s sleep because of your heartburn and/or regurgitation? | 0 | 1 | 2 | 3 |
| 6 | How often did you take additional medication for your heartburn and/or regurgitation other than what the physician told you to take (such as Maalox)? | 0 | 1 | 2 | 3 |
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