Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

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.     

MRI图像融合技术在肛瘘评估中的初步应用

目的采用图像融合技术获得T2WI与T2WI-FS的融合图像，评估其在肛瘘及肛周结构显示中的优势。 方法2016年6月至2018年6月，前瞻性选择中山大学附属第一医院29例肛瘘患者进行肛管磁共振（MR）检查，采用图像融合技术获取T2WI与T2WI-FS的融合图像T2WI-Fusion，利用Fisher score算法计算瘘管及肛门括约肌的组织间分辨力Fisher值、脂肪与肛门括约肌间的Fisher值，评估融合图像中瘘管及肛周结构的显示情况。采用改进的双刺激连续质量量表（DSCQS）对T2WI-FS、T2WI、增强3D-VIBE和T2WI-Fusion序列图像进行主观图像质量评价。 结果29例患者均成功获得T2WI与T2WI-FS的融合图像T2WI-Fusion。T2WI-Fusion、T2WI瘘管与括约肌间Fisher均值分别为6.46、3.31，T2WI-Fusion图像对瘘管的显示优于T2WI序列图像（P<0.001）。T2WI-Fusion、T2WI-FS脂肪与括约肌间Fisher均值分别为10.61、2.45，T2WI-Fusion图像对括约肌的显示优于T2WI-FS序列图像（P<0.001）。T2WI-Fusion对瘘管与括约肌的图像质量评价总评分均高于T2WI-FS、T2WI、增强3D-VIBE序列（P<0.001）。 结论MRI图像融合技术同时具备T2WI及T2WI-FS的优势，无需增加扫描序列及扫描时间，且操作简单，花费时间短，显著提高病变及肛周解剖结构的对比度和图像质量。     

Ethics as ritual: smoothing over moments of dislocation in biomedicine

Applications of biomedical R&D currently imply substantial societal concerns. This paper explores, based on semi‐structured interviews with scientists in Norway, how biomedical researchers experience and tackle such concerns in their daily work. It shows how ritualised routine responses to dislocatory moments help maintain order in the daily work of the interviewed scientists; they do not address directly but instead smooth over concerns by a ritualised way of using ethics. This may foreclose substantive reflection and function as a stabiliser for ‘business as usual’. Overall, the current way of responding to concerns as described by the interviewees may contribute to a depoliticisation of important issues. The paper contributes to sociological work on ethics by linking it to recent discussions on Responsible Research and Innovation (RRI) and by the empirical research presented. The insights can also help improve science policies such as RRI.     

Brief Educational Sessions to Promote Health App Use

The increase in smartphone ownership by underserved populations provides a unique opportunity to use technology to improve health. Health apps are often free and have programs to empower individuals to engage in health promotion and self-management of chronic illnesses. To promote the use of health apps in an underserved community, investigators provided brief educational sessions to teach individuals to how access and use health apps. Educational sessions increased health app knowledge, comfort in using health apps, and likelihood of using health apps.     

Using telepresence for social connection: views of older people with dementia,families, and health professionals from a mixed methods pilot study

Abstract

Objectives: To explore the acceptability of telepresence robots in dementia care from the perspectives of people with dementia, family carers, and health professionals/trainees, and investigate the utility of a social presence assessment tool, the Modified-Temple Presence Inventory (Modified-TPI), for people with dementia.

Method: A mixed-methods pilot study conducted in a social robotics laboratory. Three participant groups (n?=?22) – dyads of people with dementia and their carers (n?=?5 respectively), and health professionals/trainees (n?=?12) – participated in individual one-off intervention sessions with the telepresence robot, Giraff, with follow-up interviews. Sessions covered how to use Giraff, followed by interactive practice in making a video-call involving conversation and manoeuvring of Giraff. Participants with dementia experienced receiving a call made by their carer; healthcare professionals/trainees experienced making and receiving a call. Outcomes of interest were sense of presence [Modified-TPI], affective response (International Positive and Negative Affect Schedule [I-PANAS-S]; Observable Displays of Affect Scale [ODAS]), and attitudes and reactions to Giraff (semi-structured interviews).

Results: Participants reported a sense of authenticity and social connection through the experience. They indicated positive social presence through Giraff, and significantly higher positive (mean score 18.77; ±4.00) than negative affect (mean score 8.05; ±1.76) on the I-PANAS-SF, and on the facial display subscale of the ODAS (positive – mean score 15.50; ±3.51 versus negative – mean score 4.00; ±0.00).

Conclusion: Telepresence has potential use in situations where people with dementia require social connection. Studies with larger sample sizes, varied characteristics, and cost-effectiveness analysis are needed to inform the application of telepresence in healthcare practice.     

舌象分割技术的文献计量学分析

[目的]了解舌象分割技术的研究现况及发展趋势,为舌象客观化提供参考。[方法]基于中国知网、维普、万方及Pubmed数据库检索建库至2018年公开发表的舌象分割技术文献,利用Note Express 3.20、Excel 2016、SATI3.2、UCINET 6.0软件进行文献计量学及关键词共现网络分析。[结果]舌象分割技术文献研究整体呈上升趋势,北京工业大学居首位。主要基金资助为国家自然科学基金。根据普赖斯定律的要求,基本形成"核心作者群"。舌象分割以Snake模型和基于阈值的分割技术为主。关键词集中分布在"舌诊""图像分割""舌诊客观化"等方面。[结论]舌象分割技术研究仍需受到重视,国家政府应加大资助力度,加强研究机构间合作,尚存在一些舌象分割评价标准问题,需待改进。     

视神经炎的临床特征分析及早期视盘和黄斑的改变

目的　研究视神经炎患者的临床特征及早期视盘和黄斑的改变。方法　回顾性分析山西省眼科医院视神经炎患者67例85眼。分析患者基本情况、眼科检查结果及OCT检查结果。结果　67例85眼中，男24例，女43例；28例（41.8%）发生于冬季；49眼（57.6%）入院时最佳矫正视力小于1.7 logMAR。视神经脊髓炎抗体阳性者出院和入院时的最佳矫正视力均较髓鞘少突胶质糖蛋白抗体阳性者差。患眼较健眼视盘周围神经纤维层增厚，杯盘面积比、杯盘垂直比、杯盘水平比、杯容积减小，盘沿面积、视盘面积增大（均为P=0.000）；与健眼相比，患眼早期上方、下方和平均黄斑区神经节细胞层厚度及黄斑区神经节细胞复合体的局部丢失体积、整体丢失体积均未发生明显改变（均为P＞0.05）。视盘水肿与患眼平均视盘周围神经纤维层厚度存在正相关（r=0.728，P=0.000）。结论　视神经炎多发生于女性，早期视力损害严重，视神经脊髓炎抗体阳性者视力预后差。早期由于视盘水肿，视盘周围神经纤维层增厚，盘沿面积、视盘面积增大；杯容积、杯盘比减小，早期病变未累及黄斑区。     

碳纤维复合材料人工颅骨板急性期生物相容性的研究

目的 评价碳纤维复合材料人工颅骨板在急性期的生物相容性。方法 制作碳纤维复合材料、含重组人骨形态发生蛋白-2（rhBMP-2）的碳纤维复合材料、钛网、MEM培养基、含有0.64%苯酚的MEM培养基的浸出液，用于测试。采用L929小鼠成纤维细胞进行细胞毒性试验，采用健康ICR小鼠进行急性毒性试验，采用新西兰大白兔耳静脉血进行急性溶血试验，采用白化豚鼠进行皮肤致敏试验。结果 碳纤维复合材料、含rhBMP-2的碳纤维复合材料、钛网浸提液对L929细胞的相对增殖率均在75%以上，细胞毒性1级，无明显细胞毒性；小鼠腹腔注射相应材料的浸提液后，均活动良好，均无不良反应，均无明显急性毒性；碳纤维复合材料、含rhBMP-2的碳纤维复合材料、钛网浸提液溶血率均小于5%，均不引起溶血反应；碳纤维复合材料、含rhBMP-2的碳纤维复合材料、钛网浸提液不引起致敏性。结论 碳纤维复合人工颅骨板急性期生物相容性良好。