Background Radiation pneumonitis is a dose-limiting toxicity for patients undergoing concurrent chemoradiation therapy (CCRT) for non-small cell lung cancer (NSCLC). We performed an individual patient data meta-analysis to determine factors predictive of clinically significant pneumonitis. Methods After a systematic review of the literature, data was obtained on 836 patients who underwent CCRT in Europe, North America and Asia. Patients were randomly divided into training and validation sets (2/3 vs. 1/3 of patients). Factors predictive of symptomatic pneumonitis (grade ≥ 2 by one of several scoring systems) or fatal pneumonitis were evaluated using logistic regression. Recursive partitioning analysis (RPA) was used to define risk groups. Results The median radiotherapy dose was 60 Gy, and median follow-up was 2.3 years. Most patients received concurrent cisplatin/etoposide (38%) or carboplatin/paclitaxel (26%). The overall rate of symptomatic pneumonitis was 29.8% (n=249), with fatal pneumonitis in 1.9% (n=16). In the training set, factors predictive of symptomatic pneumonitis were lung volume receiving ≥20 Gy (V20) [OR:1.03 per 1% increase, p=0.008], and carboplatin/paclitaxel chemotherapy [OR:3.33, p<0.001], with a trend for age [OR: 1.24 per decade, p=0.09]; the model remained predictive in the validation set with good discrimination in both datasets (c-statistic>0.65). On RPA, the highest risk of pneumonitis (>50%) was in patients >65 years of age receiving carboplatin/paclitaxel. Predictors of fatal pneumonitis were daily dose >2 Gy, V20, and lower-lobe tumor location. Conclusions Several treatment-related risk factors predict the development of symptomatic pneumonitis, and elderly patients who undergo CCRT with carboplatin-paclitaxel chemotherapy are at highest risk. Fatal pneumonitis, although uncommon, is related to dosimetric factors and tumor location.
To determine whether an interactive curriculum that integrates dating violence prevention with lessons on healthy relationships, sexual health, and substance use reduces physical dating violence (PDV).Design: Cluster randomized trial with 2.5-year followup; prespecified subgroup analyses by sex.Setting: Grade 9 health classes.Participants: A total of 1722 students aged 14-15 from 20 public schools (52.8% girls).Intervention: A 21-lesson curriculum delivered during 28 hours by teachers with additional training in the dynamics of dating violence and healthy relationships. Dating violence prevention was integrated with core lessons about healthy relationships, sexual health, and substance use prevention using interactive exercises. Relationship skills to promote safer decision making with peers and dating partners were emphasized. Control schools targeted similar objectives without training or materials. Main Outcome Measures:The primary outcome at 2.5 years was self-reported PDV during the previous year. Secondary outcomes were physical peer violence, sub-stance use, and condom use. Analysis was by intentionto-treat. Results:The PDV was greater in control vs intervention students (9.8% vs 7.4%; adjusted odds ratio, 2.42; 95% confidence interval, 1.00-6.02; P = .05). A significant group ϫ sex interaction effect indicated that the intervention effect was greater in boys (PDV: 7.1% in controls vs 2.7% in intervention students) than in girls (12.1% vs 11.9%). Main effects for secondary outcomes were not statistically significant; however, sex ϫ group analyses showed a significant difference in condom use in sexually active boys who received the intervention (114 of 168; 67.9%) vs controls (65 of 111 [58.6%]) (PϽ.01). The cost of training and materials averaged CA$16 per student. Conclusion:The teaching of youths about healthy relationships as part of their required health curriculum reduced PDV and increased condom use 2.5 years later at a low per-student cost.
A new instrument was designed to provide a practical clinical measure for assessing children's pain intensity and pain affect. The pocket size measure includes a Coloured Analogue Scale (CAS) to assess intensity and a facial affective scale to assess the aversive component of pain. Both scales have numerical ratings on the back, so that the person administering it can quickly note the numbers that represent a child's pain. This study was conducted to determine the validity of the new instrument by evaluating the psychophysical properties of the intensity scale and by evaluating the discriminant validity of the intensity and affective scales. Since visual analogue scales (VAS) are valid and reliable measures for assessing children's pain, children's ability to use the new analog scale was compared with their performance on a VAS. Children's ability to rate pain affect using an affective scale, in which the 9 faces on a Facial Affective Scale (FAS) are presented in an ordered sequence from least to most distressed, was compared to their performance on the original FAS, in which the same faces were presented in a random order. Using a parallel groups design, 104 children (5-16 years; 60 female, 44 male; 51 healthy and 53 with recurrent headaches) were randomized into two groups: CAS or VAS. Children used the assigned scale to complete a calibration task, in which they rated the sizes of 7 circles varying in area (491, 804, 1385, 2923, 3848, 5675 and 7854 mm2). The psychophysical function relating perceived circle size to actual physical size was determined for the CAS and VAS. Children's CAS and VAS responses on the calibration task yielded similar mathematical relationships: psi cas = 0.035I0.87, psi vas = 0.027I0.89, where psi = perceived magnitude and I = stimulus intensity. The R2 values were 0.921 and 0.922 for the CAS and VAS groups, respectively. Analyses of covariance revealed no significant differences in the characteristics of these relationships, i.e., R2, slope, or y intercept, by scale type. Children used the same scale to complete the Children's Pain Inventory (CPI), in which they rated the intensity and affect of 16 painful events (varying in nature and extent of tissue damage). Children's CAS and VAS responses on the CPI were similar. Analyses of covariance indicated that there were no differences in either intensity or affective ratings by scale type. However, the mean number of painful events experienced by children increased significantly with age (P = 0.0001). Intensity ratings decreased significantly with age (P = 0.002), but affective ratings did not vary with age. The new instrument has equivalent psychometric properties to a 165 mm VAS. However, the CAS was rated as easier to administer and score than the VAS, so it may be more practical for routine clinical use. Since the CAS has fulfilled the first two criteria for a pain measure (psychophysical properties and discriminant validity), it is ethical to proceed with the formal definitive test for construct validity, in which children from vari...
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