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101.
102.
《Value in health》2022,25(12):1958-1966
ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed. 相似文献
103.
Sandrine F. Chebekoue 《Journal of occupational and environmental hygiene》2019,16(4):308-319
This study aimed at deriving occupational thresholds of toxicological concern for inhalation exposure to systemically-acting organic chemicals using predicted internal doses. The latter were also used to evaluate the quantitative relationship between occupational exposure limit and internal dose. Three internal dose measures were identified for investigation: (i) the daily area under the venous blood concentration vs. time curve, (ii) the daily rate of the amount of parent chemical metabolized, and (iii) the maximum venous blood concentration at the end of an 8-hr work shift. A dataset of 276 organic chemicals with 8-hr threshold limit values-time-weighted average was compiled along with their molecular structure and Cramer classes (Class I: low toxicity, Class II: intermediate toxicity, Class III: suggestive of significant toxicity). Using a human physiologically-based pharmacokinetic model, the three identified dose metrics were predicted for an 8-hr occupational inhalation exposure to the threshold limit value for each chemical. Distributional analyses of the predicted dose metrics were performed to identify the percentile values corresponding to the occupational thresholds of toxicological concern. Also, simple linear regression analyses were performed to evaluate the relationship between the 8-hr threshold limit value and each of the predicted dose metrics, respectively. No threshold of toxicological concern could be derived for class II due to few chemicals. Based on the daily rate of the amount of parent chemical metabolized, the proposed internal dose-based occupational thresholds of toxicological concern were 5.61?×?10?2 and 9?×?10?4 mmol/d at the 10th percentile level for classes I and III, respectively, while they were 4.55?×?10?1 and 8.5?×?10?3 mmol/d at the 25th percentile level. Even though high and significant correlations were observed between the 8-hr threshold limit values and the predicted dose metrics, the one with the rate of the amount of chemical metabolized was remarkable regardless of the Cramer class (r2 = 0.81; n = 276). The proposed internal dose-based occupational thresholds of toxicological concern are potentially useful for screening-level assessments as well as prioritization within an integrated occupational risk assessment framework. 相似文献
104.
《Research in social & administrative pharmacy》2022,18(9):3699-3703
As one of the overreaching goals of Healthy People 2030, addressing the social determinants of health (SDOH) to reduce health disparities is a nationwide concern, with objectives informed by interdisciplinary teams of experts. However, there remains much discussion regarding the roles of healthcare providers in addressing SDOH. While current guidance suggests that all members of the healthcare team must be empowered to address SDOH, current guidance explicitly references physicians, nurses, social workers and staff, and do not specifically include pharmacists. While pharmacists are taught about the impact of SDOH in pharmacy curricula, actionable strategies for pharmacists to address SDOH in practice have not been clearly outlined. Pharmacists have multifaceted interactions with patients and may be influential in meeting individual patient needs, identifying social risk factors, and addressing upstream causes of health disparities. This paper proposes a framework for the role of pharmacists in addressing the SDOH through strategies at the patient, practice, and community levels. The concepts presented in this paper are meant to serve as a launch point for discussion and to promote the inclusion of pharmacists in the conversations around sustainable efforts to achieve health equity. This framework is not intended to limit the scope of pharmacists in addressing SDOH – on the contrary, it is our hope that this outline may be used to expand the education of future healthcare professionals regarding their role in addressing the social determinants of health. 相似文献
105.
“课程思政”是当前高等教学中加强大学生思想政治教育的主要途径之一。本文通过探索中医院校“预防医学”课程思政的建设,从教学内容、教学方法、教学团队建设、考核方式四个方面论述了专业知识传授和思政教育育人的有机融合,在教学中实施“知识传授”与“价值引领”同向同行,培养德术兼备的“卓越医生”。 相似文献
106.
Thomas W. McDade Alexander V. Georgiev Christopher W. Kuzawa 《Evolution, Medicine, and Public Health》2016,2016(1):1-16
Immune defenses provide resistance against infectious disease that is critical to survival. But immune defenses are costly, and limited resources allocated to immunity are not available for other physiological or developmental processes. We propose a framework for explaining variation in patterns of investment in two important subsystems of anti-pathogen defense: innate (non-specific) and acquired (specific) immunity. The developmental costs of acquired immunity are high, but the costs of maintenance and activation are relatively low. Innate immunity imposes lower upfront developmental costs, but higher operating costs. Innate defenses are mobilized quickly and are effective against novel pathogens. Acquired responses are less effective against novel exposures, but more effective against secondary exposures due to immunological memory. Based on their distinct profiles of costs and effectiveness, we propose that the balance of investment in innate versus acquired immunity is variable, and that this balance is optimized in response to local ecological conditions early in development. Nutritional abundance, high pathogen exposure and low signals of extrinsic mortality risk during sensitive periods of immune development should all favor relatively higher levels of investment in acquired immunity. Undernutrition, low pathogen exposure, and high mortality risk should favor innate immune defenses. The hypothesis provides a framework for organizing prior empirical research on the impact of developmental environments on innate and acquired immunity, and suggests promising directions for future research in human ecological immunology. 相似文献
107.
Anna Grace Tribble Phillip Summers Haiying Chen Sara A. Quandt 《Archives of environmental & occupational health》2016,71(6):309-316
The jobs of Latino manual laborers place their mental and physical health at risk. This study evaluates the associations among musculoskeletal pain, mental health, and work organization in Latino manual laborers. Farmworkers and nonfarmworkers (n = 189) in North Carolina were interviewed for self-reported musculoskeletal pain, depressive symptoms, stress, work safety climate, and precarious job status. More nonfarmworkers than farmworkers had neck and shoulder pain, but they did not differ in other areas of musculoskeletal pain. Depressive symptoms had a significant association with neck and shoulder pain (p < .05). Precariousness had a significant association with back pain (p < .05). Farmworker participants had H-2A visas and were afforded some protection compared to nonfarmworker manual workers. Research is needed to improve policy that relieves pain and improves mental health for all Latino manual workers. 相似文献
108.
在现代传媒背景下,媒介素养水平高低直接影响着医药专业人才的培养质量和未来我国医药卫生事业发展。本文探讨国内外媒介素养教育开展情况,分析医药院校大学生媒介素养教育的必要性,提出了在医药院校加强媒介素养教育的新思路。 相似文献
109.
110.
Joseane Balan Da Silva Gleison Daion Piovezana Bossolani Camila Piva Greicy Brisa Malaquias Dias Jancarlo Gomes Ferreira Diogo Francisco Rossoni 《International journal of environmental health research》2016,26(5-6):578-588
The spatial distribution of enteroparasitosis in an indigenous village from Paraná was evaluated to identify areas of risk for these infections. A cross-sectional study (from November 2010 to June 2011) was performed using Three Faecal Test® and Kato &; Katz method and a questionnaire on housing and hygiene conditions was administered. Local geostatistical analyses were performed to determine the spatial distribution of intestinal parasitic infections. The overall prevalence of enteroparasites was 67.2?% (457/680), and the most prevalent taxa were Ascaris lumbricoides (48.8?%) and Trichuris trichiura (44.7?%). The prevalence of heavy infection by soil-transmitted helminths was 3.6?% and the families lived in houses with an average of 5.1 residents and < 2 bedrooms per household. The average number of species per individual present spatial heterogeneity with the highest values (≥0.8) in areas with high clustering of residences. The visualization of the spatial distribution of intestinal parasites in this indigenous village is an important contribution to determining health risk areas and planning decisions and services. 相似文献