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• W2003991421 abstract "The diagnosis and assessment of reflux disease has gone though a major evolution over the years. Initially, reflux disease was almost a radiological diagnosis, based on the finding of a hiatus hernia. The advent of endoscopy and the identification of reflux esophagitis focused attention on the endoscopic diagnosis for over 20 years and defined (and sometimes confined) treatment with acid suppressants in some countries, including Australia. The recognition that the majority of patients with reflux disease do not have endoscopically visible mucosal lesions has focused attention on the importance of symptoms as the primary basis for diagnosis.1 The cardinal symptoms of reflux disease, heartburn and regurgitation, have been recognized for many years and heartburn, when it is the predominant symptom, may be the sole basis for the diagnosis of reflux disease. However, heartburn and regurgitation, while relatively specific, are not sensitive for reflux disease. Many patients have a mixture of upper gastrointestinal symptoms, including those that may be attributable to functional dyspepsia and irritable bowel syndrome,2 and some patients may report predominantly atypical symptoms such as cough, chest pain or laryngeal symptoms. Furthermore, heartburn, as a term, is poorly identified by patients as the cause of their symptoms.3,4 Clinical trials of drugs to treat endoscopy-negative reflux disease fuelled the need for standardized criteria by which not only to recruit patients but also to assess the response to therapy. Questionnaires address some of these objectives.5 They minimise interobserver variability, facilitate quantitative assessment of subject responses and they are an efficient inexpensive method of symptom assessment. In addition, they are an effective method for the identification of patients for epidemiological studies. Self-assessment by the patient also has the advantage of using the patient and not the observer to assess symptoms. Physicians tend to underscore the severity of symptoms.6,7 Patient reporting of symptoms independently of the investigator's assessment is now generally required by regulatory authorities for acceptance of clinical trial data in reflux disease. Symptom measurements can be broadly grouped into three types: (i) discriminative—that focus on the diagnosis and discriminate between groups and classify, according to symptoms, severity and frequency, and that should be highly specific for the disease in question; (ii) predictive—that indicate the likelihood of a specific disease; and (iii) evaluative—that measure the magnitude of change in symptom severity over time. The early questionnaires3,4,8 were primarily discriminative and directed towards the diagnosis of reflux disease based on symptom patterns. A common feature of these was the use of a descriptive definition of heartburn rather than relying on the term itself, which was found to enhance recognition of the symptom by patients, as well as to predict the response to acid-suppressant therapy. More recent questionnaires have widened the spectrum of assessment by including a measure of the intensity and severity of symptoms,9,10 as a well as the symptom burden and the impact on the patient's quality of life.11 The demands of clinical trials has also lead to the development of evaluative questionnaires that are responsive to treatment of change such as the ReQuest11 and Gastroesophageal Reflux Disease Symptom Assessment Scale.9 The combination of an evaluative questionnaire (ReQuest) and endoscopy has lead to the concept of ‘complete remission’.12 To date, however, questionnaires have not reflected the severity of esophagitis. It is well recognized that the relationship between symptoms and the presence and severity of esophagitis is poor13 and that the symptom duration, frequency and severity in patients with non-erosive reflux disease do not differ significantly from those in erosive disease.14–16 The disparity is particularly so in older patients.17 The Frequency Scale for Symptoms of Gastroesophageal Reflux Disease (FSSG) is a Japanese-developed instrument based on 12 questions derived from a field of 50 questions related to the frequency of gastroesophageal reflux symptoms, ulcer-like symptoms and psychosomatic symptoms.18 Using a cut-off score of 8 points, these 12 questions showed a moderate sensitivity (62%) and sensitivity and specificity (59%) for endoscopy-positive reflux disease. After treatment with a proton pump inhibitor (PPI), a reduction in FSSG score was associated with a reduction in the severity of esophagitis both in patients with mild as well as severe reflux disease. A subsequent study reported that the FSSG also predicted the need for the addition of prokinetic therapy.19 In this issue of the Journal, Fujimoto and colleagues report the results of a multicenter study comparing the correlation of two reflux disease questionnaires, the FSSG and the Carlsson-Dent questionnaire, with endoscopic findings in undifferentiated patients with upper gastrointestinal symptoms associated with peptic ulcer disease, functional dyspepsia and endoscopy-positive reflux disease.20 As with the previous reports, both questionnaires showed moderate sensitivity of approximately 65% for endoscopy-positive reflux disease. However, whereas the Carlsson-Dent questionnaire scored significantly higher with reflux disease than with all other diseases, the FSSG could not differentiate clearly between reflux disease and gastric ulcer. Restricting the FSSG score to those questions related to reflux symptoms increased the separation between reflux disease and the other disorders. In contrast to the Carlsson-Dent questionnaire, the FSSG score was also related to the severity of esophagitis and was significantly higher in patients with severe LA grades C and D esophagitis than the lower grades, although it could not differentiate between the less severe grades of esophagitis. However, the actual difference between the groups appears to be relatively small and, although individual patient data are not provided, it seems unlikely that any given FSSG score could predict the endoscopic grade. It is important that questionnaires be valid for the population being studied as differences exist in the interpretation of terms for symptoms among ethnic groups. The FSSG provides another option for the assessment of reflux symptoms in a Japanese population. However, it does not appear to be measurably better than the Carlsson-Dent questionnaire. The reason for the finding of a relationship between the FSSG score and endoscopic grade of esophagitis in this current study, in contrast to the very poor correlation between endoscopic grade and both symptom severity and frequency in previous studies is unclear. The Japanese studies have included minimal changes in the classification of endoscopic esophagitis, and such patients formed a substantial (30%) proportion of the reflux patients. However, the FSSG score was significantly higher only for the most severe grades of esophagitis, LA grades C and D. Reflux disease questionnaires have been a valuable tool for clinical and pharmaceutical research where a patient's independent assessment of symptom severity and response to therapy are essential. They are also an efficient and cost-effective means of surveying populations for epidemiological studies. Their role in clinical practice, however, is unclear. Potentially, gastrointestinal symptom questionnaires could serve to characterize patients ahead of a clinical consultation. A short version of the ReQuest questionnaire has been developed.21 A recent evaluation, however, reported that the diagnostic performance of the Carlsson-Dent questionnaire in general practice was no better than clinical judgment.22 This may reflect the significant proportion of patients who do not experience heartburn or regurgitation as the predominant symptoms, as well as potential improvements in clinical diagnosis through understanding gained from use of questionnaires. Additionally, commercial interests related to the cost of development of these questionnaires renders access difficult for the general clinician. The development of reflux disease questionnaires has been an important advance in the objective standardized and reproducible assessment of reflux symptoms, their impact on the patient's quality of life and their response to treatment. Questionnaires are now indispensible to the conduct of clinical trials and are valuable for epidemiological research. Their value to routine clinical medicine, however, remains to be established." @default.
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• W2003991421 date "2009-08-01" @default.
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• W2003991421 title "Questionnaires in gastroesophageal reflux disease: What do the answers mean?" @default.
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