目的 从伦理审查的视角调查医院临床研究中知情同意书质量,分析申办者和研究者发起的临床研究中知情同意书存在的主要问题,对其要点进行评价归纳并提出建议.方法 收集整理上海市某三级甲等医院伦理委员会2013年1月—2020年12月接受伦理审查的临床研究项目知情同意书共计678项,根据《药物临床试验质量管理规范》要求对知情同意书的内容和语言等要素进行统计分析.结果 完全符合规范的知情同意书311份(占45.9％),存在要素和/或语言问题的知情同意书367份(占54.1％),问题主要体现在研究过程(占23.7％)、可能的风险(占15.5％)、受损害后的赔偿补偿(占15.0％)和研究相关费用的告知(占14.2％)等方面;申办者发起的临床研究的知情同意书合格率高于研究者发起的临床研究.结论 合格的知情同意书文本应保证内容完整和语言规范,以达到信息完整、理解无误、自愿同意的效果,确保受试者做出符合其真实意愿的选择.对于知情同意书质量的保障,需要包括申办者、研究者和伦理委员会在内的临床研究各相关方的共同努力.

目的 探讨显微镜下睾丸取精术(m-TESE)在非梗阻性无精子症(NOA)治疗中的应用,并分析影响手术结局的因素和预测指标.方法 回顾性收集2017年6月-2020年1月在上海交通大学附属第一人民医院就诊的677例NOA患者资料,统计患者手术结局,分析患者无精子症相关病因分类、年龄、性激素[卵泡刺激素(FSH)、黄体生成素(LH)、睾酮(T)、雌二醇(E2)、泌乳素(PRL)、抗苗勒管激素(AMH)和抑制素B]水平与手术结局的关系.结果 纳入患者的FSH和LH分别为(27.5±15.7)和(14.3±9.1) U/L,均显著高于正常值上限.NOA患者病因分类依次为,特发性NOA 454例(67.1％),克氏综合征73例(10.8％),精索静脉曲张63例(9.3％),隐睾或有隐睾手术史45例(6.7％),Y染色体AZFc缺失19例(2.8％),睾丸炎16例(2.4％),辐射或放射治疗、化学治疗史7例(1.0％).成功获取179例(26.4％)患者的精子;其中,睾丸炎患者取精成功率最高,为13/16;辐射或化学治疗、放射治疗史患者最低,为1/7.根据手术结局,将特发性NOA患者分为成功组和失败组.成功组患者的FSH和LH水平均显著高于失败组,而AMH水平显著低于失败组(P值均＜0.05).logistic回归分析结果表明,AMH、FSH和LH均对手术结局有一定的预测价值,其中AMH的拟合优度最佳(x2=31.477,P=0.0001).绘制ROC曲线,AMH的AUC为0.713,FSH和LH分别为0.576和0.552.1例(0.1％)患者术后出现切口感染.结论 m-TESE是治疗NOA的有效方法,患者病因是影响手术结局的重要因素.对于特发性NOA患者,AMH对手术结局的预测能力最高.

目的:目前研究者发起的临床研究质量管理体系尚不完善,通过探讨研究者发起的临床研究开展过程质量管理实施办法,以促进研究质量提升,保护受试者安全.方法:本文总结了研究实施阶段开展过程质量管理的内容、程序和保障因素,探讨了针对研究者发起的临床研究进行过程质量管理的一些做法和经验.结果:研究进行初期及进行中,侧重研究方案修改管理、伦理跟踪审查、授权分工、研究进度与随访、执行的规范性、经费管理等,并关注数据的完整性和可溯源性.开展质量控制的时间可从首例开始,便于尽早发现问题并及时处理.结论:研究者发起的临床研究过程质量管理是保障研究质量的关键,应加大投入,切实落实.

Background: Multidrug-resistant organisms (MDROs) have become a global threat to public health. MDROs normally are transmitted from patient to patient via the hands of healthcare workers (HCWs). The key management of MDROs is control of dissemination as soon as possible. Method: We established a bedside prediction tool based simply on experiences. According to the result of this predictive rule, we took a series of precautions in a general intensive care unit (ICU) from January 1, 2018, to December 31, 2019, in only one ward experimentally. We retrospectively analyzed medical records of patients between two wards to assess the efficiency of the routine care practice by performing different comparisons. Results: A total of 636 patients were admitted in the ICU setting. After comparing two wards in hospital expenses and length of ICU stay, there were no significant differences. Precautions contributed to the association between room number and status of MDRO infection/colonization ( p =0.033), and the infection/colonization rate of MDROs was significantly different between the two wards ( p =0.006). The median of the length of clinical culture testing is 3.4 days. Conclusion: Clinical culture testing is time-consuming. Advanced routine care practice controlled the cross-transmission of MDROs to some extent. This study highlights that a predicting model of MDROs is badly needed. Future researchers can engage in updating the predictive model focusing from machine learning-based risk algorithms, refer to experts’ experiences and adopt more efficient precautions for strengthening the transmission efficiency.

研究者发起的临床研究数量迅速增长,是促进临床创新和提升诊疗技术的重要支撑.多数研究者发起的临床研究过程缺乏规范管理,其中对受试者的隐私保护不足是较为突出的问题.从临床研究数据的应用环境、采集、存取、审查、保护和销毁等多个角度,对当前临床研究中研究者隐私保护意识不足、安全审查与保护措施较少、伦理审查不充分等问题进行分析和讨论,并针对存在的问题提出建立或完善临床研究数据管理体系、加强对受试者隐私保护的伦理审查能力、提高研究人员对隐私保护的认识和开展临床研究数据隐私保护的相关研究等建议.以期在充分保障受试者个人隐私权益的基础上推动规范开展临床研究,促进医学研究事业的健康发展.

Objective:To explore the application of information management platform for Investigator Initiated clinical trials (IIT).Methods:Elaborate the design and application of Clinical Information Management Platform (CIMP). Discuss the obstacles in platform development.Results:Compared with regions where clinical research is more developed, there is still a lack of standardized and efficient information management methods in China. Through the construction of the IIT information management platform, the scientific management of the IIT and the SWOT analysis of the use of the platform have been conducted. Further exploration and improvement are needed in terms of the collaboration of the information platform, data standardization, and information sharing security.Conclusions:The management efficiency can be improved by applying CIMP, which will also promote the smooth implementation of IITs.

Objective: To study the efficacy and safety of low-intensity pulsed ultrasound (LIPUS) at different intervals by mechanical force in treating erectile dysfunction (ED). Method: Forty patients with mild to moderate ED were randomized in a 1∶1 ratio to receive 16-treatment sessions of LIPUS in group A and group B, applied 3 times per week and 2 times per week, respectively. End-point assessments were made at 8th week after treatment. Efficacy were evaluated using International Index of Erectile Function-Erectile Function domain score (IIEF-EF), Erectile Hardness Score (EHS), Self-Esteem and Relationship Questionnaire (SEAR), Sexual Encounter Profile (SEP), Global Assessment Question (GAQ), and pain were assessed by Visual Analogue Score (VAS).Treatment response was confirmed by a minimal clinically importance difference (MCID) at 8th week. Results: Compared with baseline, IIEF-EF score [(17.1±5.48 vs 23.4±3.75, P<0.05) and (18.9±4.34 vs 24.1±4.32, P<0.05)], proportion of EHS 4 [(0 vs 40%, P<0.05) and (16.7% vs 55.6%, P<0.05)], and Overall Relationship score [(50.6 vs 67.5, P<0.05) and (44.4 vs 70.1, P<0.05)] were significantly improved at 8th week in two groups, respectively. Compared with baseline, the positive responses to SEP-3 increased significantly at 8th week in two groups (50.0% vs 80.0%,P<0.05) and (44.4% vs 88.9%, P<0.05), respectively. The positive responses to GAQ-2 were 90.0% and 88.9% at 8th week in two groups, respectively. There were no significant differences in IIEF-EF, EHS, SEAR, SEP and GAQ at 8th week between two groups. There was no significant difference in treatment response using MCID between two groups at end-point (80.5% vs 77.5%). The treatment duration for full sessions were 2.5 weeks less in group A than group B. No adverse effects were reported in all cases. Conclusion: LIPUS at two different intervals is effective and safe for mild to moderate ED, and the regimen at 3 times per week can achieve quite good effect in relatively short duration,while the long-term effects is still be clarified in further study.

Objective With the fast development of Investigator-Initiated Trials (IIT),more and more resources from the national and local governments,universities and hospitals were invested.It is important to clarify the content and methodologies of quality evaluation of the IITs at the early approval stage to assure more complete and systematic quality assessment,improve resource allocation,enhance the research ability,as well as the protection of human subject.Methods This article summarized the content and related safeguarding measures of quality assessment during the early stage of project setup.Discussed relative practice and experiences of our center.Results The contents of quality evaluation include research topic,study protocol,research team and qualifications,quality assurance plan and risk management.The organizing work and attention of the research administrative department,qualified departments and experts,as well as information platform are the required safeguarding measures for effective assessment.Conclusions Quality evaluation of IITs at the early approval stage is critical segment of study quality assurance.More attention should be paid to make every effort counts.

目的 ·探讨经玻璃体切割术后不同的玻璃体填充物对孔源性视网膜脱离(rhegmatogenous retinal detachment,RRD)患者黄斑区血流的影响,以及黄斑区血流与最佳矫正视力的相关性.方法 ·回顾性分析2017年12月-2018年6月于上海交通大学附属第一人民医院眼科行玻璃体切割术的单眼初发RRD患者74例.根据玻璃体切割术后填充物的不同,将患者分为气体填充组(气体组)和硅油填充组(硅油组).利用光学相干断层扫描血管成像(optical coherence tomography angiography,OCTA)技术行黄斑区3 mm×3mm区域扫描.记录黄斑区中心凹及旁中心凹处浅层视网膜毛细血管丛(superficial capillary plexus,SCP)血流密度、深层视网膜毛细血管丛(deep capillary plexus,DCP)血流密度,黄斑区中心凹无血管区(foveal avascular zone,FAZ)面积、周长.分析2组患者黄斑区血流参数与最佳矫正视力的相关性.结果 ·与硅油组相比,气体组患者术后6个月的总3 mm×3mm区域SCP血流密度及DCP血流密度均较高(均P=0.000).偏相关分析显示,患者的最佳矫正视力变化与FAZ面积的变化呈负相关性(r=-0.216,P=0.015).结论 ·RRD患者行玻璃体切割术联合气体填充术后对其黄斑区血流的恢复更为有利.使用OCTA技术评估视网膜脱离患者玻璃体切割术后患眼的黄斑区血流密度变化,对于监测视网膜结构和功能的变化有重要意义.

学习型企业建设的基本内涵和要求 从实践的角度看,创建学习型企业,其实质就是要在企业确立一种理念、营造一种氛围、形成一种机制,即确立职工持续学习、终身学习的理念,营造工作学习化、学习工作化的氛围,形成有利于职工学习、团队学习的运行与保障机制;其关键就是要推进全员性、全面性、全程性的职工教育,即把职工教育作为组织管理的先进形式贯穿于企业改革、生产、经营、发展的各时期、各环节以及各方面;其根本要求一是使企业各级领导、各类职工逐步实现全员、全面、全程的学习培训;二是使企业及企业内部的各个层级、各类单位逐步成为学习培训、交流沟通、共享知识、密切协作的最佳组织形式;其主要成果最终应反映在企业经营管理的效益、综合竞争的实力与全面发展的后劲上.因此,从一定意义上讲,建设学习型企业,即是对传统型职工教育培训的质的飞跃、量的扩展、效的提升.