Evaluación del impacto de un plan multisectorial de promoción de la salud y el bienestar social en Andalucía

ObjectiveTo evaluate the impact of the Plan for the promotion of personal autonomy and prevention of disability in Andalusia (2016-2020) in 13 public administrations during the first year of its implementation; and to analyse the usability and feasibility of the impact assessment ladder used.MethodThe Plan addresses the promotion of personal autonomy and the prevention of disabilities and dependencies through a multisectoral approach. It is structured in strands or lines of work, objectives and actions that have been assessed through the Adoption Impact Ladder (AIL). The analysis of the face validity, feasibility and inter-rater reliability of the impact assessment ladder was carried out in 30 actions of the Plan that were rated by 20 experts from the 13 ministries and public agencies involved in the Plan, and an external rater.Results176 actions and programmes were launched in 2017. Of these, 67.2% were implemented during the first year. Only one of the 16 objectives had no action initiated during the first year. Moreover, 7 out of 15 objectives implemented were fully multisectoral involving more than three Regional Ministries. The face validity, feasibility and inter-rater reliability of the AIL were good (κ: 0.72).ConclusionsThis Plan has provided a novel framework to coordinate a broad range of proposed policies and actions within the public administration of Andalusia. For the first time, a multisectoral impact analysis has been conducted providing an effective guide for monitoring, planning and setting public priorities in health, social services, ageing and disabilities.     

The Geriatrician: The Frontline Specialist in the Treatment of COVID-19 Patients

On February 20, 2020, a man living in the north of Italy was admitted to the emergency room with an atypical pneumonia that later proved to be COVID-19. This was the trigger of one of the most serious clusters of COVID-19 in the world, outside of China. Despite aggressive restraint and inhibition efforts, COVID-19 continues to increase, and the total number of infected patients in Italy is growing daily. After 6 weeks, the total number of patients reached 128,948 cases (April 5, 2020), with the higher case-fatality rate (15,887 deaths) dominated by old and very old patients.This sudden health emergency severely challenged the Italian Health System, in particular acute care hospitals and intensive care units. In 1 hospital, geriatric observation units were created, the experience of which can be extremely useful for European countries, the United States, and all countries that in the coming days will face a similar situation.     

Effects of Medications and Subthalamic Nucleus-Deep Brain Stimulation on the Cutaneous Silent Period in Patients With Parkinson's Disease

ObjectivesWe sought to evaluate whether the cutaneous silent period (CSP) could be an electrophysiological indicator reflective of the effects of therapy for Parkinson's disease (PD), including anti-PD medications or deep brain stimulation (DBS).Material and MethodsWe recorded the CSP in 43 patients with PD prior to and following the administration of medication during a pre-DBS evaluation (30 cases) and the “on” and “off” states of subthalamic nucleus DBS (13 cases). The CSP was elicited from the abductor pollicis brevis muscle by an electrical stimulation of the index finger that was 2, 4, and 15 times stronger than the sensory threshold (ST). We measured changes in latencies, including the onset, duration, and end of CSP, and waveform scores from 0 to 3. The correlation between the CSP score and unified PD rating score part III (UPDRS-III) also was assessed.ResultsThe onset latency and duration of CSP were significantly different between high- (15ST) and low-strength stimulations (2ST and 4ST). However, there were no significant latency changes (onset, duration, end of CSP) before and after receiving medication, or during the on and off state of the DBS. Anti-PD medications substantially increased the CSP waveform score only in the 4ST state. However, the waveform score significantly increased in all stimuli states during the DBS-on state. Both medication and the DBS-on state decreased the UPDRS-III. Nevertheless, there was no statistically significant correlation between the UPDRS-III and CSP waveform scores.ConclusionDifferent onset latencies and the duration of CSP between low- and high-strength stimuli support the hypotheses proposing two different reflex pathways. Despite being independent from the UPDRS-III, the CSP may be an electrophysiological indicator reflective of the changes in inhibitory activity to the spinal α-motoneuron in response to anti-PD medications and DBS.     

颞叶癫痫发作间期PET-CT与VEEG检查对致癫灶的诊断价值比较

目的 比较分析颞叶癫痫发作间期正电子发射计算机断层显像（PET-CT）和视频脑电图（VEEG）检查对致癫灶的诊断价值。方法 回顾性分析2016年3月至2018年3月手术治疗的80例单侧颞叶癫痫的临床资料。另选取同期健康体检者30例作为对照。术前进行PET-CT和VEEG监测定位致痫灶，以术中监测结果为定位致痫灶的金标准。利用受试者工作特征（ROC）曲线评价PET-CT放射性分布不对称指数（AI）对颞叶癫痫致癫灶的诊断价值。结果 PET-CT、VEEG确定致癫灶的灵敏度分别为88.73%、47.89%，特异度分别为88.89%、66.67%。颞叶癫痫发作间期病灶侧AI显著高于非病灶侧（P<0.05），同时也显著高于健康体检者颞叶内侧AI（P<0.05）及颞叶外侧AI（P<0.05）。ROC曲线分析结果显示，AI=0.153诊断颞叶癫痫致癫灶的曲线下面积为0.730，95%置信区间在0.544~0.916。结论 颞叶癫痫发作间期PET-CT脑显像定位准确率优于VEEG，对手术治疗准确定位有很高的应用价值，且AI为0.153时诊断癫痫灶的效果最好。     

多学科管理下鸟氨酸氨甲酰基转移酶缺乏症妇女连续三次妊娠分娩健康儿一例

本文报告1例鸟氨酸氨甲酰基转移酶缺乏症患者3次妊娠,最终在多学科管理下分娩一健康新生儿的诊疗经过。2013年患者首次妊娠,孕28周出现急性高氨血症收入上海交通大学医学院附属新华医院,诊断为鸟氨酸氨甲酰基转移酶缺乏症。给予低蛋白饮食及降血氨治疗,并在多学科管理下于孕32周剖宫产一男婴,但该男婴生后第3天死亡。基因分析提示患者及其新生儿鸟氨酸氨甲酰基转移酶基因均存在c.583G>A(G195R)突变。2015年患者再次自然妊娠,但产前诊断提示胎儿为男性,且鸟氨酸氨甲酰基转移酶基因存在同一位点纯合突变,于孕21周引产终止妊娠。2017年借助体外受精-胚胎移植及植入前基因诊断技术第3次妊娠,并在多学科管理下最终顺利分娩一名健康男婴。     

HPLC-ABTS-DAD-Q-TOF/MS在线检测大黄抗氧化活性成分

目的：建立大黄特征化学成分和抗氧化活性相关联的二维指纹图谱，研究大黄抗氧化活性物质。方法：利用高效液相多检测器联用的抗氧化活性成分在线检测体系，对大黄中化学成分进行检测，共鉴定出大黄中化学成分15种；其中8种具有抗氧化活性；然后采用清除效率为指标对各活性成分的抗氧化活性进行评价。结果：结果发现化合物葡萄糖紫丁香酸、腺嘌呤、没食子酸、儿茶素或表儿茶素、双花母草素、2-O-桂皮酰-没食子酰葡萄糖等具有较强的清除ABTS^·+的活性，而蒽醌类成分对ABTS^·+的清除作用较弱。结论：采用HPLC-ABTS-DAD-Q-TOF/MS对大黄中的抗氧化活性成分进行快速分析鉴定，初步阐明大黄在抗氧化环节起作用的效应物质。     

Incorporating a companion test into the noninferiority design of medical device trials

Noninferiority trials are commonly utilized to evaluate the safety and effectiveness of medical devices. It could happen that the noninferiority hypothesis is rejected while the performance of the active control is clinically not satisfactory. This may pose a great challenge when making a regulatory decision. To avoid such a difficult situation, we propose to conduct a companion test to assess the performance of the active control when testing the main noninferiority hypothesis and to incorporate such a test into the study design. Under our proposal, the noninferiority of the investigational device to the active control can only be claimed when both hypotheses are rejected. The operating characteristics of the proposed study design based on these two tests can be fully evaluated at the design stage. This proposed approach is aimed to facilitate regulatory decision making in a more transparent manner.     

Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen

We make the case for why continuous pharmaceutical manufacturing is essential, what the barriers are, and how to overcome them. To overcome them, government action is needed in terms of tax incentives or regulatory incentives that affect time.