中国循证医学杂志最新文献

英文中文

The application and promotion of electronic informed consent 电子知情同意的应用及推广

Q4 Medicine

中国循证医学杂志

Pub Date : 2021-01-01 DOI: 10.7507/1672-2531.202102042

Y. Dong, L. Qin, W. Wu, C. Tang, W. Long, Z. Yang, L. Ling, L. Lu

Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China. © 2021 West China University of Medical Science. All rights reserved.

在COVID-19全球大流行的背景下，电子知情同意(eConsent)利用技术为临床试验提供了新的方法和思路。它具有方便快捷的优点，大大提高了临床试验的效率。目前国内还没有提出这一概念，而国外已经明确了这一概念，一些国家已经开展了各种试点，制定了各种法规，进一步规范eConsent。本研究基于eConsent在中国的现状，分析了eConsent的设计与实施，总结了国内外相关法律法规，提出了电子知情同意技术在中国实施的机遇与挑战以及相关准备工作。©2021华西医科大学。版权所有。

引用次数: 1

Safety of COVID-19 vaccine: A meta-analysis COVID-19疫苗的安全性:一项meta分析

Q4 Medicine

中国循证医学杂志

Pub Date : 2021-01-01 DOI: 10.7507/1672-2531.202102056

C. Liu, Yaolong Chen, S. Zhao, S. Dong, Y. Zhang, Y. Zhao, Q. Zhu, H. Jin

Objective To systematically review the safety of different types of COVID-19 vaccines in the population. Methods Web of Science, PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) which reported safety of COVID-19 vaccines in population. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using RevMan 5.4 software. Results A total of 5 RCTs involving 2 431 subjects were included. The results of the meta-analysis showed that COVID-19 vaccines developed more fever symptoms than placebo (RR=2.21, 95%CI 1.38 to 3.54, P=0.000 9). However, there was no significant difference in the incidence of adverse reactions (RR=1.28, 95%CI 0.96 to 1.70, P=0.10), injection site adverse reactions (RR=1.47, 95%CI 0.65 to 3.36, P=0.36) and systemic adverse reactions (RR=0.96, 95%CI 0.78 to 1.17, P=0.66) between two groups. Conclusions Current evidence shows that COVID-19 vaccines are sufficiently safe. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions. © 2021 West China University of Medical Science. All rights reserved.

目的系统评价不同类型新型冠状病毒疫苗在人群中的安全性。方法电子检索Web of Science、PubMed、EMbase、Cochrane Library、中国知网(CNKI)、万方数据(WanFang Data)和CBM数据库，收集报道COVID-19疫苗在人群中安全性的随机对照试验(RCTs)。两名审稿人独立筛选文献、提取数据并评估纳入研究的偏倚风险。采用RevMan 5.4软件进行meta分析。结果共纳入5项随机对照试验，共纳入受试者2 431人。meta分析结果显示，新冠肺炎疫苗比安慰剂出现更多发热症状(RR=2.21, 95%CI 1.38 ~ 3.54, P= 0.0009)，但两组不良反应发生率(RR=1.28, 95%CI 0.96 ~ 1.70, P=0.10)、注射部位不良反应发生率(RR=1.47, 95%CI 0.65 ~ 3.36, P=0.36)和全身不良反应发生率(RR=0.96, 95%CI 0.78 ~ 1.17, P=0.66)差异无统计学意义。目前的证据表明，COVID-19疫苗足够安全。由于纳入研究的质量和数量有限，需要更多高质量的研究来验证上述结论。©2021华西医科大学。版权所有。

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引用次数: 0

The application of extracorporeal membrane oxygenation in patients with COVID-19: A systematic review and meta-analyses of cohort studies 体外膜氧合在COVID-19患者中的应用:队列研究的系统回顾和荟萃分析

Q4 Medicine

中国循证医学杂志

Pub Date : 2021-01-01 DOI: 10.7507/1672-2531.202101122

S. Yi, M. Mingyuan, G. Qianqian, G. Liheng

Objective To systematically review the application of extracorporeal membrane oxygenation (ECMO) in patients with coronavirus disease 2019 (COVID-19). Methods PubMed, The Cochrane Library, EMbase, CBM, WanFang Data and CNKI databases were searched for studies on ECMO for COVID-19 from December 1st, 2019 to December 31st, 2020. Two researchers independently screened literature, extracted data, and evaluated the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 24 studies were included, involving 1 576 acute respiratory distress syndrome (ARDS) patients with COVID-19. The overall mortality of patients was 27.3% (430/1 576). The rate of ECMO treatment was 4.68% (379/1 576), and the survival rate was 69.4% (263/379). The mean duration of mechanical ventilation prior to ECMO treatment for ARDS patients ranged from 2.07±0.40 to 15.89±13.0 days, compared with 1.64±0.78 days and 29.9±3.60 days for ECMO treatment. Of the 11 studies included in the meta-analysis, 84.0% (405/482) patients with ARDS received conventional treatment with COVID-19, and 16.0% (77/482) received ECMO treatment on the basis of conventional treatment with ARDS. Results of meta-analysis showed that there was statistically significant difference in the survival rate of ARDS patients with COVID-19 treated with conventional therapy combined with ECMO or with conventional therapy alone (RR=1.27, 95%CI 1.00 to 1.62, P=0.05). Conclusions This study suggests that the survival rate of COVID-19 patients after ECMO treatment has a tendency to improve. Due to the limitation of quantity and quality of included studies, the above conclusions are needed to be verified by more high-quality studies. © 2021 West China University of Medical Science. All rights reserved.

目的系统回顾体外膜氧合(ECMO)在2019冠状病毒病(COVID-19)患者中的应用。方法检索2019年12月1日至2020年12月31日PubMed、Cochrane Library、EMbase、CBM、万方数据和中国知网数据库中关于COVID-19 ECMO的相关研究。两位研究者独立筛选文献，提取数据，并评估纳入研究的偏倚风险。采用RevMan 5.3软件进行meta分析。结果共纳入24项研究，纳入1 576例新冠肺炎急性呼吸窘迫综合征(ARDS)患者。总死亡率为27.3%(430/1 576)。ECMO治愈率为4.68%(379/1 576)，生存率为69.4%(263/379)。ECMO治疗前机械通气的平均持续时间为2.07±0.40 ~ 15.89±13.0天，而ECMO治疗前机械通气的平均持续时间为1.64±0.78天和29.9±3.60天。meta分析纳入的11项研究中，84.0%(405/482)的ARDS患者接受了COVID-19的常规治疗，16.0%(77/482)的ARDS患者在常规治疗的基础上接受了ECMO治疗。meta分析结果显示，常规治疗联合ECMO与单独常规治疗合并COVID-19的ARDS患者生存率差异有统计学意义(RR=1.27, 95%CI 1.00 ~ 1.62, P=0.05)。结论新冠肺炎患者经ECMO治疗后生存率有提高的趋势。由于纳入研究数量和质量的限制，上述结论需要更多高质量的研究来验证。©2021华西医科大学。版权所有。

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引用次数: 0

Design of the master protocol platform trial and its application in related fields 主协议平台试验设计及其在相关领域的应用

Q4 Medicine

中国循证医学杂志

Pub Date : 2021-01-01 DOI: 10.7507/1672-2531.202104005

Z. Guan, Y. Liu, J. Zhang, Yaolong Chen, H. Dai, X. Zhang, M. Hu, H. Shang

The master protocol platform trial is a trial in which multiple treatments or different combinations of treatments are consistently evaluated in the context of a single disease, possibly within several sub-studies for different disease subtypes, allowing multiple treatments to enter or exit the trial platform based on a certain decision algorithm. Compared with the traditional clinical trial design, the master protocol platform trial as a scientific innovative model of clinical trial can accelerate drug evaluation to deal with the contradiction between the awaited evaluation of numerous drugs and lack of effective therapy for diseases. By using the large-scale randomized controlled clinical trial for COVID-19 inpatients (RECOVERY) led by the University of Oxford in the UK in 2020 as an illustration, this paper introduced the concept, design principle, and basic trial process of the master protocol platform trial to provide methodological references for clinical research of drugs. © 2021 West China University of Medical Science. All rights reserved.

主方案平台试验是在单一疾病背景下，对多种治疗或不同治疗组合进行一致评估的试验，可能在不同疾病亚型的几个子研究中，允许多种治疗根据一定的决策算法进入或退出试验平台。与传统的临床试验设计相比，主方案平台试验作为一种科学的临床试验创新模式，可以加速药物的评价，解决众多药物等待评价与疾病缺乏有效治疗之间的矛盾。本文以2020年英国牛津大学牵头开展的新冠肺炎住院患者(恢复期)大规模随机对照临床试验为例，介绍主方案平台试验的概念、设计原则和基本试验流程，为药物临床研究提供方法学参考。©2021华西医科大学。版权所有。

引用次数: 0

Public anticipation of clinician graduates in the new era of healthy China: A questionnaire-based cross-sectional study 健康中国新时代公众对临床医师毕业生的期望:一项基于问卷的横断面研究

Q4 Medicine

中国循证医学杂志

Pub Date : 2021-01-01 DOI: 10.7507/1672-2531.202006087

X. Zheng, Xinran Sun, Q. Zhang, Q. Liu, Y. Yuan

Objective The purpose of this study was to offer new suggestions for current clinician training under the guidance of the Healthy China 2030 policy by investigating the patients' needs. Methods This study surveyed adult outpatients from West China Hospital of Sichuan University between March and July, 2019 and February and May, 2020 by self-constructed questionnaires to investigate the expectation and requirements of outpatients towards medical professionals. Results A total of 430 questionnaires were distributed, and 402 of them (93.5%) were collected and included in this study. All questionnaire respondents expected that medical graduates should have outstanding expertise and ethical standard. The majority valued qualities such as physical and mental health (90.05%), a bachelor's degree or higher (73.88%), knowledge on disease control and prevention (61.69%), knowledge on health care (91.29%), ability to continuously update current knowledge (70.65%), and excellent communication (71.14%) and teamwork (62.44%) skills. In addition, most patients expected that new health care providers to possess humanitarianism and professional dedication relevant traits, and could improve diagnoses and treatments via research activities. Patients' demand for abilities such as disease control and prevention, health care, and integrative cooperation between traditional Chinese medicine and modern medicine significantly increased after the COVID-19 pandemic (P<0.05). Conclusions Nowadays, to provide health care services which meet the needs of the public, clinicians are expected to have qualities such as outstanding expertise, humanity, research and knowledge-updating skills, disease control and prevention, health care management, and capability to take the advantages of traditional Chinese medicine and modern medicine. © 2021 West China University of Medical Science. All rights reserved.

目的通过对患者需求的调查，为健康中国2030政策指导下的临床医师培训提供新的建议。方法采用自编问卷对2019年3月至7月和2020年2月至5月在四川大学华西医院就诊的成年门诊患者进行调查，了解门诊患者对医疗专业人员的期望和要求。结果共发放问卷430份，回收402份(93.5%)纳入本研究。所有被调查者都期望医学毕业生具有杰出的专业知识和道德标准。大多数人看重的素质包括身心健康(90.05%)、本科及以上学历(73.88%)、疾病预防控制知识(61.69%)、卫生保健知识(91.29%)、不断更新现有知识的能力(70.65%)、优秀的沟通能力(71.14%)和团队合作能力(62.44%)。此外，大多数患者期望新的医疗服务提供者具有人道主义和专业奉献的相关特征，并能通过研究活动改善诊断和治疗。新冠肺炎疫情后，患者对疾病预防控制、卫生保健、中西医结合配合等能力的需求显著增加(P<0.05)。结论当前，要提供满足公众需求的卫生保健服务，临床医生需要具备优秀的专业技能、人文素质、研究和知识更新能力、疾病预防控制能力、卫生保健管理能力以及中西医结合的能力。©2021华西医科大学。版权所有。

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引用次数: 0

Prevalence of depression and anxiety among health care workers in designated hospitals during the COVID-19 epidemic: A meta-analysis 2019冠状病毒病流行期间指定医院医护人员抑郁和焦虑患病率:一项荟萃分析

Q4 Medicine

中国循证医学杂志

Pub Date : 2021-01-01 DOI: 10.7507/1672-2531.202105079

X. Liu, G. Wang, J. Zhang, S. Wang

Objective To systematically review the prevalence of depression and anxiety among health care workers in designated hospitals during the COVID-19 pandemic. Methods The Cochrane Library, PubMed, EMbase, Web of Science, CNKI, WanFang Data, VIP, and CBM databases were electronically searched to collect cross-sectional studies on the prevalence of depression and anxiety among health care workers from December 2019 to April 2021. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using Stata 14.0 software. Results A total of 21 cross-sectional studies were included, involving 38 372 participants. Meta-analysis results showed that during the COVID-19 epidemic, the prevalence of depression and anxiety among health care workers in designated hospitals were 31.00% (95%CI 0.25 to 0.37) and 44.00% (95%CI 0.34 to 0.53). The results of subgroup analysis showed that individuals of female, married, bachelor degree or above, nurses, junior professional titles, and non-first-line medical staff had higher prevalence of depression and anxiety. Conclusions During the COVID-19 pandemic, the incidence of depression and anxiety among health care workers in designated hospitals remain high. Therefore, more attention should be paid to the mental health of health care workers in designated hospitals. Due to the limited quantity and quality of included studies, more high-quality studies are needed to verify the above conclusions. © 2021 West China University of Medical Science. All rights reserved.

目的系统了解2019冠状病毒病大流行期间定点医院医护人员抑郁和焦虑的流行情况。方法电子检索Cochrane Library、PubMed、EMbase、Web of Science、CNKI、万方数据、VIP和CBM数据库，收集2019年12月至2021年4月期间医护人员抑郁和焦虑患病率的横断面研究。两位审稿人独立筛选文献，提取数据，并评估纳入研究的偏倚风险。采用Stata 14.0软件进行meta分析。结果共纳入21项横断面研究，涉及38372名受试者。meta分析结果显示，2019冠状病毒病流行期间，定点医院医护人员抑郁和焦虑患病率分别为31.00% (95%CI 0.25 ~ 0.37)和44.00% (95%CI 0.34 ~ 0.53)。亚组分析结果显示，女性、已婚、本科及以上学历、护士、初级职称和非一线医务人员的抑郁和焦虑患病率较高。结论2019冠状病毒病大流行期间，定点医院医护人员抑郁和焦虑发生率居高不下。因此，应更加重视定点医院医护人员的心理健康。由于纳入的研究数量和质量有限，需要更多高质量的研究来验证上述结论。©2021华西医科大学。版权所有。

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引用次数: 5

Nosocomial infection prevention and control: Another main battlefield for new coronavirus pneumonia 医院感染防控:新冠肺炎又一主战场

Q4 Medicine

中国循证医学杂志

Pub Date : 2020-10-01 DOI: 10.7507/1672-2531.202002029

Qi Wu

The prevention and control of COVID-19 has entered a critical moment "Disease control of 2019 novel coronavirus infection in hospital: West China urgent recommendation" based on the best available evidence and expert experience, provided emergency recommendations for key clinical issues in hospital prevention and control during the COVID-19 epidemic This recommendation with strong reference value and timeliness is worth learning for hospital managers, sensory control personnel and medical staff at all levels All medical institutions should establish an emergency response mechanism to accelerate the formation of medical teams and strengthen the protection of medical staff and hospital infection control We should enhance the implementation of policy and reinforce risk assessment It is essential to strengthen the implementation of various prevention and control measures as well as risk assessment so as to eventually win the battle of coronavirus infection as soon as possible © 2020 West China University of Medical Science All rights reserved

引用次数: 0

Emergency rescue of novel coronavirus pneumonia: Exploration from China 新型冠状病毒肺炎应急救援：来自中国的探索

Q4 Medicine

中国循证医学杂志

Pub Date : 2020-07-01 DOI: 10.7507/1672-2531.202002010

Jie Jiang, Yongqing Yuan, Ting Cheng, J. Guo, Jiajie Yu, Youping Li

To systematically and retrospectively analyze Chinese exploration of novel coronavirus pneumonia, including emergency command, medical treatment, health and disease prevention, resource scheduling and other aspects, in order to provide references for the prevention and treatment of global infectious diseases.

系统回顾性分析新型冠状病毒肺炎的中国探索，包括应急指挥、医疗、卫生防疫、资源调度等方面，为全球传染病防治提供参考。

引用次数: 0

Development of rapid advice guidelines in public health emergency 制定突发公共卫生事件快速咨询准则

Q4 Medicine

中国循证医学杂志

Pub Date : 2020-05-01 DOI: 10.7507/1672-2531.202003097

Yaolong Chen, Xianzhuo Zhang, Ling Wang, Qi Wang, Xufei Luo, Yanfang Ma, E. Liu, Z. Luo, Qiu Li, Z. Fu, Weiguo Li

引用次数: 0

超声刀对比传统手术在腮腺浅叶切除术中安全性的 Meta 分析超声刀对比传统手术在腮腺浅叶切除术中安全性的 Meta 分析

Q4 Medicine

中国循证医学杂志

Pub Date : 2019-01-01 DOI: 10.7507/1672-2531.201903077

Jinzhu Zhao, Xiangqian Zheng, Ming Gao, Jiadong Chi, Xin-wei Yun

引用次数: 0

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中国循证医学杂志

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