Quality assurance in a phase III, multicenter, randomized trial of POstmastectomy radioThErapy in Node posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a planning benchmark case.

PURPOSE: To report the planning benchmark case results of the POTENTIAL trial-a multicenter, randomized, phase 3 trial-to evaluate the value of internal mammary nodal (IMN) irradiation for patients with high-risk breast cancer. METHODS: All participating institutions were provided the outlines of one benchmark case, and they generated radiation therapy plans per protocol. The plans were evaluated by a quality assurance team, after which the institutions resubmitted their revised plans. The information on beams arrangement, skin flash, inhomogeneity corrections, and protocol compliance was assessed in the first and final submission. RESULTS: The plans from 26 institutions were analyzed. Some major deviations were found in the first submission. The protocol compliance rates of dose coverage for the planning target volume of chest wall, supraclavicular fossa plus axilla, and IMN region (PTVim) were all significantly improved in the final submission, which were 96.2% vs. 69.2%, 100% vs. 76.9%, and 88.4% vs. 53.8%, respectively. For OARs, the compliance rates of heart Dmean, left anterior descending coronary artery V40Gy, ipsilateral lung V5Gy, and stomach V5Gy were significantly improved. In the first and final submission, the mean values of PTVim V100% were 79.9% vs. 92.7%; the mean values of heart Dmean were 11.5 Gy vs. 9.7 Gy for hypofractionated radiation therapy and 11.5 Gy vs. 11.0 Gy for conventional fractionated radiation therapy, respectively. CONCLUSION: The major deviations were corrected and protocol compliance was significantly improved after revision, which highlighted the importance of planning benchmark case to guarantee the planning quality for multicenter trials.

Variability of Target Volumes and Organs at Risk Delineation in Breast Cancer Radiation Therapy: Quality Assurance Results of the Pretrial Benchmark Case for the POTENTIAL Trial.

PURPOSE: To estimate the variations in clinical target volumes (CTVs) and organs at risk delineation within the quality assurance (QA) program of the POTENTIAL trial, which is a multicenter, randomized phase 3 trial evaluating postmastectomy radiation therapy (RT), with or without internal mammary nodal irradiation, for patients with high-risk breast cancer. METHODS AND MATERIALS: The simulating computed tomography scan data set of a benchmark case was sent to the participating centers, and the delineation of CTVs and organs at risk was required to be completed by the investigators following protocol guidelines. All submitted contours were reviewed and compared with the reference contours created by the QA team, using quantitative geometric analysis regarding volume and the Jaccard Index (JCI), Dice similarity coefficient, Geographic Miss Index, Discordance Index, and mean distance to agreement. In addition to the whole-volume analysis of all structures, the combination contour of the supraclavicular fossa and level III and II axilla (CTVsc + axIII + axII) was further analyzed on a slice-by-slice basis. RESULTS: The contours from 26 centers were reviewed and variations were observed between submission and reference. The variations of the CTV of the chest wall, contralateral breast, and heart were small, for which the mean JCI values were 0.62, 0.68, and 0.87, respectively. However, the mean JCI values of the CTV of the internal mammary nodal region, ipsilateral brachial plexus, left anterior descending coronary artery, and right coronary artery were 0.38, 0.21, 0.29, and 0.18, respectively, suggesting marked variations. In addition, marked under- and overoutlining variations were identified on 4 slices of CTVsc + axIII + axII on slice-by-slice analysis. CONCLUSIONS: There were residual contouring variations despite a detailed protocol being provided, confirming the importance of pretrial QA in RT and highlighting the need for education and consideration of a real-time central review of the target delineation before the trial participants begin RT.

An Unmanned Aerial Vehicle-Mounted Cold Mist Spray of Permethrin and Tetramethylfluthrin Targeting Aedes albopictus in China.

Aedes albopictus is the primary vector of dengue fever and dengue hemorrhagic fever in China. Although there are previous studies on the application of adulticides to control this species, the application methods have either been back-pack or vehicle-mounted systems. However, many sites are too large to be effectively treated with back-pack sprayers, and the lack of roads restricts the use of vehicle-mounted sprayers. This paper provides the first study of using unmanned aerial vehicles to conduct cold mist sprays on Ae. albopictus habitats. A spray containing 4% permethrin and 1% tetramethylfluthrin was applied at an effective application rate of 9.0 mg/m(2). This method reduced Ae. albopictus populations by more than 90%. The results indicate this novel spray system is a powerful method to achieve a rapid decline of mosquito population in Ae. albopictus habitats in China.

Diagnostic efficiency of hemoglobin A1c for newly diagnosed diabetes and prediabetes in community-based Chinese adults aged 40 years or older.

BACKGROUND: Europeans and Americans are gradually accepting the hemoglobin A1c (HbA1c) threshold of 6.5% for diagnosing diabetes proposed by the American Diabetes Association, but the cutoff of HbA1c for the Chinese population is unclear. We evaluated the diagnostic efficiency of HbA1c for diagnosing newly diagnosed diabetes and prediabetes in community-based Chinese adults 40 years of age or older. SUBJECTS AND METHODS: In this study 8,239 subjects (5,496 women) 40-90 years of age underwent HbA1c and oral glucose tolerance test measurement after an overnight fast. Diabetes and prediabetes were defined by the World Health Organization criteria. The area under the receiver operating characteristic curve (AUC) was used to evaluate the diagnostic efficiency of HbA1c, and the optimal cutoff was defined as the point on the receiver operating characteristic curve with the largest Youden index. Spearman correlation was used for correlation analysis. RESULTS: The prevalence of newly diagnosed diabetes and prediabetes was 10.7% (880/8,239) and 19.0% (1,564/8,239), respectively. Fasting plasma glucose and postprandial plasma glucose were positively correlated with HbA1c level (r=0.725 and r=0.673, both P<0.001, respectively). For diagnosing diabetes, the AUC was 0.857 (95% confidence interval, 0.841-0.873), and the optimal cutoff for HbA1c was 6.3%, with the largest Youden index being 0.581. For diagnosing prediabetes, the AUC was 0.681 (95% confidence interval, 0.666-0.697), and the optimal cutoff for HbA1c was 5.9%, with the largest Youden index being 0.280. CONCLUSIONS: An HbA1c threshold of 6.3% was highly valuable for diagnosing newly diagnosed diabetes, and a value of 5.9% was weakly valuable for diagnosing prediabetes in community-based Chinese adults 40 years of age or older.

Optimal waist circumference cut-off values for identifying metabolic risk factors in middle-aged and elderly subjects in Shandong Province of China.

OBJECTIVE: To study the optimal waist circumference (WC) cut-off values for identifying metabolic risk factors in middle-aged and elderly subjects in Shandong Province of China. METHODS: A total of 2,873 men and 5,559 women were included in this cross-sectional study. Metabolic syndrome (MetS) was diagnosed according to the definition of Chinese Diabetes Society in 2004. The relation between WC and MetS was analyzed by multivariate logistic regression analysis. The optimal WC cut-off values were identified using the area under the ROC curve and the different diagnostic criteria for central obesity were compared. RESULTS: The WC was the risk factor for MetS independent of BMI, blood glucose, blood lipid, and blood pressure. The optimal WC cut-off value was 83.8 cm and 91.1 cm for identifying MetS in women and men, respectively. Compared with 80 cm and 85 cm for women and men, 85 cm and 90 cm had a higher Youden index for identifying all metabolic risk factors and MetS in women and men. CONCLUSION: The appropriate WC cut-off value is 85 cm and 90 cm for identifying central obesity and MetS in women and men in Shandong Province of China.