Clinical validation of the "7 × 7" questionnaire for patients with functional gastrointestinal disorders.

BACKGROUND AND AIM: Physicians use different scales and questionnaires to assess the severity of clinical symptoms in patients with functional gastrointestinal disorders. The current study aimed to validate the "7 × 7" questionnaire for assessment of severity of the symptoms as a tool for the efficacy of treatment of functional gastrointestinal disorders, using the Clinical Global Impressions scale as the reference standard.

METHODS: Fifty inpatients aged from 18 to 64 with a confirmed diagnosis of irritable bowel syndrome (26 patients, 52%), functional dyspepsia (15 patients, 30%), or both (9 patients, 18%) were prospectively enrolled in the study. We used both the 7 × 7 questionnaire and the Clinical Global Impressions scale before and after 28 days of stable treatment.

RESULTS: Our study revealed a significant correlation between the 7 × 7 questionnaire and the Clinical Global Impressions scale results in assessment of severity of the clinical symptoms and their dynamics during treatment. The 7 × 7 questionnaire showed sensitivity of 74.5% and specificity of 54.1% for evaluating patients with mild to severe disease and 66.6% and 76%, respectively, for evaluating patients with moderate to severe disease. The Cronbach's alpha coefficient was 0.719. The intraclass correlation coefficient among participants in whom the condition remained the same was 0.973 (12 participants [24.5%]).

CONCLUSIONS: The 7 × 7 questionnaire is a convenient, sensitive, and reliable tool for assessing the severity of symptoms and treatment efficacy in people with functional gastrointestinal disorders.