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Background & Aims: Guidelines recommend a positive strategy based on symptom criteria to diagnose patients with irritable bowel syndrome (IBS). We conducted a randomized noninferiority trial to determine whether a positive diagnostic strategy is noninferior to a strategy of exclusion, with regard to patients' health-related quality of life (HRQOL). Methods: We studied 302 patients (18–50 years old) from primary care who were suspected of having IBS and referred by general practitioners. Patients who fulfilled the Rome III criteria for IBS with no alarm signals were randomly assigned to groups assessed by a strategy of exclusion (analyses of blood, stool samples for intestinal parasites, and sigmoidoscopies with biopsies) or a positive strategy (analyses of blood cell count and C-reactive protein). Patients were followed for 1 year. The primary end point was difference in change of HRQOL from baseline to 1 year between groups (on the basis of the Short Form 36 health survey, physical component summary, and noninferiority margin of 3 points). Secondary outcomes were change in gastrointestinal symptoms, satisfaction with management, and use of resources. Findings of diagnostic misclassification were registered. Results: A positive strategy was noninferior to a strategy of exclusion (difference, 0.64; 95% confidence interval, −2.74 to 1.45). The positive diagnostic strategy had lower direct costs. Each approach had similar effects on symptoms, satisfaction, and subsequent use of health resources. No cases of inflammatory bowel disease, colorectal cancer, or celiac disease were found. Conclusions: In diagnosing IBS in primary care, use of a positive diagnostic strategy is noninferior to using a strategy of exclusion with regard to the patients' HRQOL. Our findings support the current guideline recommendations. ClinicalTrials.gov, Number NCT00659763 and NCT01153295. [Copyright &y& Elsevier]

Abstract: Objective: Otitis media (OM) is a common childhood disease and a frequent reason for seeking medical care in general practice. Only few studies have focused on what happens after diagnosis and initial treatment of OM. In particular, there is a lack of research on how different patient- and disease-related factors influence the course of OM. The aim of this study was to analyze to what extent symptoms at the time of initial diagnosis are associated with the short-term course of otitis media. Methods: Cohort study in general practice comprising 747 children between 0 and 7 years with a new ear symptom. At the first consultation the GPs registered symptoms, results of otoscopy and tympanometry, together with diagnosis and treatment. The children were followed up four weeks later. Results: Sleep problems at inclusion are statistically significant associated with having one or more symptom after four weeks in children between 0 and 2 years (OR: 2.02 (95% confidence interval (CI): 1.24–3.31)). If the result of tympanometry is a flat curve, the OR for being referred is 3.24 (CI: 1.61–6.55) in children between 0 and 2 years compared to children without a flat curve. The OR for being referred in children between 2 and 7 years with a flat curve is 8.94 (CI: 4.18–19.11) when compared to children without a flat curve. Conclusion: Sleep problems at inclusion were the only symptom statistically significant associated with having one or more symptoms after four weeks in children between 0 and 2 years. [Copyright &y& Elsevier]