Prospective external validation of IOTA three-step strategy for characterizing and classifying adnexal masses and retrospective assessment of alternative two-step strategy using simple-rules risk.

OBJECTIVES: To perform an external validation of the diagnostic performance of the three-step strategy proposed by the International Ovarian Tumor Analysis (IOTA) group for classifying adnexal masses as benign or malignant, when ultrasound is performed by non-expert sonographers in the first two steps. The second objective was to assess the diagnostic performance of an alternative strategy using simple-rules risk (SRR), instead of simple rules (SR), in the second step. METHODS: This was a prospective observational study conducted at two university hospitals, from September 2015 to August 2017, of consecutive patients diagnosed with an adnexal mass. All women were evaluated by ultrasound using the IOTA three-step strategy. Non-expert sonographers performed the first step (use of simple descriptors to classify the masses) and the second step (use of SR if the mass could not be classified in the first step); masses that could not be classified in the first two steps were categorized by an expert sonographer based on their subjective assessment (third step). The reference standard was histological diagnosis in patients who underwent surgery or at least 12 months of follow-up in cases managed expectantly. The sensitivity, specificity, positive (LR+) and negative (LR-) likelihood ratios and overall accuracy of the IOTA three-step strategy were estimated. Furthermore, we evaluated retrospectively an alternative two-step strategy using SRR in the second step to categorize the masses not classifiable with simple descriptors, classifying the lesions as being of low, intermediate or high risk for malignancy. The diagnostic performance of this strategy was estimated by calculating its sensitivity and specificity, assuming surgical intervention for intermediate- or high-risk lesions. RESULTS: The study included 283 patients (median age, 48 (range, 18-90) years), of whom 165 (58.3%) were premenopausal and 118 (41.7%) postmenopausal. Two hundred and sixteen (76.3%) women underwent surgery (154 benign and 62 malignant masses) and 67 (23.7%) were managed expectantly with serial ultrasound follow-up for at least 12 months. All expectantly managed masses were considered benign because no sonographic changes suggestive of malignancy were observed during follow-up. Simple descriptors could be applied in 126 (44.5%) masses. Of the remaining 157 lesions, 112 (39.6%) could be characterized using SR. Therefore, 238 (84.1%) masses could be classified by non-expert sonographers in the first two steps. Of the remaining 45 (15.9%) masses, all could be classified by an expert sonographer. Overall sensitivity, specificity, LR+ and LR- of the IOTA three-step strategy were 95.2%, 97.7%, 42.1 and 0.05, respectively. The diagnostic accuracy was 97.2%. Following the two-step strategy using SRR in the second step, of the 157 lesions not classified with simple descriptors, 42, 38 and 77 presented low, intermediate or high risk for malignancy, respectively. Based on this method, 210 women would have undergone surgical treatment. The sensitivity and specificity of this two-step strategy were 98.4% and 63.8%, respectively. CONCLUSIONS: The IOTA three-step strategy shows high accuracy for discriminating between benign and malignant adnexal lesions when used by non-expert sonographers. An alternative strategy using the SRR calculator in the second step might improve on this diagnostic performance by decreasing the number of surgical interventions and increasing sensitivity. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

[Risk factors for increased cost of exacerbations of chronic bronchitis and chronic obstructive pulmonary disease]. / Factores de riesgo de elevado coste de las agudizaciones de la bronquitis crónica y la EPOC.

OBJECTIVE: To identify what variables characterizing the patients, exacerbations, and treatment of chronic bronchitis and chronic obstructive pulmonary disease (COPD) are associated with a higher direct health cost. METHOD: Observational pharmacoeconomic study of exacerbations of chronic bronchitis and COPD (of probable bacterial etiology, defined as Anthonisen types I or II). Direct health costs were assessed during 30 days of follow-up. Logistic regression was employed for statistical analysis, with calculation of the adjusted odds ratios (OR). An exacerbation cost greater than 150 euros was defined as the dependent variable. RESULTS: Data on 1164 patients were collected by 252 physicians. Pharmacoeconomic data were complete in 947 patients (82.6%). In the first 30 days, 206 sought medical attention because of unsatisfactory response to treatment (21.8%), 69 (7.3%) attended the emergency room, and 22 (2.3%) were admitted to hospital. Overall, 101 exacerbations (10.7%) were classified as high cost (> 150 euros). Continuous oxygen therapy (OR = 7.58) and previous hospitalization (OR = 2.6) were associated with high-cost exacerbations, whereas diagnosis of chronic bronchitis (OR = 0.41) and treatment of the exacerbation with moxifloxacin or amoxicillin-clavulanic acid as opposed to clarithromycin (OR = 0.38) were associated with low-cost exacerbations. CONCLUSION: Treatment failure was reported for 21.8% of the patients with exacerbations of chronic bronchitis and COPD. Repeated medical visits and requests for complementary tests were the main factors responsible for increased cost. Variables associated with high-cost exacerbations were continuous oxygen therapy, previous hospitalization, and treatment with clarithromycin as opposed to moxifloxacin or amoxicillin-clavulanic acid.