RESUMEN
Background: Access to essential cancer medicines is a key determinant of childhood cancer survival. WHO published the Model List of Essential Medicine for Children (EMLc) and updated it every two years since 2007 to promote better access to medicines for children. This study aimed to assess whether the inclusion of essential anticancer medicines for respective indications for children was based on evidence of significant clinical benefit between 2011 and 2021. Methods: We identified all anticancer medicine indications added to the WHO EMLc Section 8 since 2011 and extracted evidence of benefit documented in the corresponding technical reports. Evidence in children was defined as evidence that included participants under 12, and graded into five levels, according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. We analyzed whether each anticancer medicine indication was listed with documented OS benefit or improvements in surrogate measures based on the highest level of documented evidence in children. Findings: A total of 115 anticancer medicine indications were added to the EMLc from 2011 to 2021, of which 101 (87.8%) had some clinical evidence in children and 4 (3.5%) were added without any clinical evidence. Among the 101 medicine indications, none were added with level-1 evidence in children, and 43 (42.6%), 11 (10.9%), 41 (40.6%), and 6 (5.9%) were listed with level-2, level-3, level-4, and level-5 evidence in children, respectively. Only eight (7.9%) medicine indications were reported to have OS benefit, another 12 (11.9%) were reported to have improvements on surrogate measures, and 81 (80.2%) were listed in the EMLc without documented improvements in either OS or surrogate measures. Interpretation: Most anticancer medicine indications of the WHO EMLc were added based on limited evidence of statistically significant clinical benefit in children. Our results suggest that WHO should refine requirements for clinical benefit criteria and permissible forms, quality, and reporting of evidence of essential anticancer medicines for children, specify whether anticancer medicine indications have required evidence of clinical benefit in children, and provide further details in its technical reports that summarise the available evidence. Funding: Not applicable.
RESUMEN
Despite impairments in social communication in children with autism spectrum disorder (ASD), existing studies only examine the effects of either MT or DMT interventions. In the family setting, few studies have investigated interventions for social communication impairments in children with ASD. This study designed and tested a mixed intervention program of both MT and DMT through a 3-month intervention and training for children with ASD in the family setting including parent and child. A pre-test and post-test were conducted in the experimental and control groups, and the childhood autism rating scale (CARS) and autism treatment evaluation checklist (ATEC) scales were used to assess the severity of ASD symptoms and the effects of intervention. A t-test and analysis of variance were performed based on the experimental results. The results indicated that the experimental and control groups did not differ significantly on the CARS pre-test (t = 1.218, p > 0.05) and that there was no significant difference in the ATEC pre-test (t = 0.546, p > 0.05; F = 0.074, p > 0.05, partial η2 = 0.003). There was no significant difference between the pre- and post-test scores for the CARS in the control group (t = 0.635, p > 0.05), and there was no significant difference between the pre- and post-test scores for the ATEC in the control group (t = 0.027, p > 0.05; F = 5.251, p > 0.05, partial η2 = 0.313). There was a significant difference between the pre- and post-test scores on the CARS in the experimental group (t = 4.327, p > 0.05) and the pre- and post-test scores on the ATEC in the experimental group (t = 5.763, p > 0.01; F = 32.615, p > 0.01, partial η2 = 0.759), with the post-test scores being lower than the pre-test scores. This demonstrates that the mixed intervention of MT and DMT in the family parent-child setting can reduce autism and improve social communication impairment in children with ASD.
