Methodological quality(risk of bias) assessment tools for primary and secondary medical studies: What are they and which is better?

Methodological quality(risk of bias)assessment is an important step before study initiation usage.Therefore,accurately judging study type is the first priority,and the choosing proper tool is also important.In this review,we introduced methodological quality assessment tools for randomized controlled trial(including individual and cluster),animal study,non-randomized interventional studies(including follow-up study,controlled before-and-after study,before-after/pre-post study,uncontrolled longitudinal study,interrupted time series study),cohort study,case-control study,cross-sectional study(including analytical and descriptive),observational case series and case reports,comparative effectiveness research,diagnostic study,health economic evaluation,prediction study(including predictor finding study,prediction model impact study,prognostic prediction model study),qualitative study,outcome measurement instruments(including patient-reported outcome measure development,content validity,structural validity,internal consistency,cross-cultural validity/measurement invariance,reliability,measurement error,criterion validity,hypotheses testing for construct validity,and responsiveness),systematic review and meta-analysis,and clinical practice guideline.The readers of our review can distinguish the types of medical studies and choose appropriate tools.In one word,comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.

Perceived infection transmission routes, infection control practices, psychosocial changes, and management of COVID-19 infected healthcare workers in a tertiary acute care hospital in Wuhan: a cross-sectional survey

Background:Many healthcare workers were infected by coronavirus disease 2019(COVID-19)early in the epidemic posing a big challenge for epidemic control.Hence,this study aims to explore perceived infection routes,influencing factors,psychosocial changes,and management procedures for COVID-19 infected healthcare workers.Methods:This is a cross-sectional,single hospital-based study.We recruited all 105 confirmed COVID-19 healthcare workers in the Zhongnan Hospital of Wuhan University from February 15 to 29,2020.All participants completed a validated questionnaire.Electronic consent was obtained from all participants.Perceived causes of infection,infection prevention,control knowledge and behaviour,psychological changes,symptoms and treatment were measured.Results:Finally,103 professional staff with COVID-19 finished the questionnaire and was included(response rate:98.1%).Of them,87 cases(84.5%)thought they were infected in working environment in hospital,one(1.0%)thought their infection was due to the laboratory environment,and 5(4.9%)thought they were infected in daily life or community environment.Swab of throat collection and physical examination were the procedures perceived as most likely causing their infection by nurses and doctors respectively.Forty-three(41.8%)thought their infection was related to protective equipment,utilization of common equipment(masks and gloves).The top three first symptoms displayed before diagnosis were fever(41.8%),lethargy(33.0%)and muscle aches(30.1%).After diagnosis,88.3%staff experienced psychological stress or emotional changes during their isolation period,only 11.7%had almost no emotional changes.Arbidol(Umifenovir;an anti-influza drug;69.2%)was the drug most commonly used to target infection in mild and moderate symptoms.Conclusion:The main perceived mode of transmission was not maintaining protection when working at a close distance and having intimate contact with infected cases.Positive psychological intervention is necessary.

Chemoprophylaxis, diagnosis, treatments, and discharge management of COVID-19: An evidence-based clinical practice guideline(updated version)

The novel severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)is the cause of a rapidly spreading illness,coronavirus disease 2019(COVID-19),affecting more than seventeen million people around the world.Diagnosis and treatment guidelines for clinicians caring for patients are needed.In the early stage,we have issued"A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus(2019-nCoV)infected pneumonia(standard version)";now there are many direct evidences emerged and may change some of previous recommendations and it is ripe for develop an evidence-based guideline.We formed a working group of clinical experts and methodologists.The steering group members proposed 29 questions that are relevant to the management of COVID-19 covering the following areas:chemoprophylaxis,diagnosis,treatments,and discharge management.We searched the literature for direct evidence on the management of COVID-19,and assessed its certainty generated recommendations using the Grading of Recommendations,Assessment,Development and Evaluation(GRADE)approach.Recommendations were either strong or weak,or in the form of ungraded consensus-based statement.Finally,we issued 34 statements.Among them,6 were strong recommendations for,14 were weak recommendations for,3 were weak recommendations against and 11 were ungraded consensus-based statement.They covered topics of chemoprophylaxis(including agents and Traditional Chinese Medicine(TCM)agents),diagnosis(including clinical manifestations,reverse transcription-polymerase chain reaction(RT-PCR),respiratory tract specimens,IgM and IgG antibody tests,chest computed tomography,chest X-ray,and CT features of asymptomatic infections),treatments(including lopinavirritonavir,umifenovir,favipiravir,interferon,remdesivir,combination of antiviral drugs,hydroxychloroquine/chloroquine,interleukin-6 inhibitors,interleukin-1 inhibitors,glucocorticoid,qingfei paidu decoction,lianhua qingwen granules/capsules,convalescent plasma,lung transplantation,invasive or noninvasive ventilation,and extracorporeal membrane oxygenation(ECMO)),and discharge management(including discharge criteria and management plan in patients whose RT-PCR retesting shows SARS-CoV-2 positive after discharge).We also created two figures of these recommendations for the implementation purpose.We hope these recommendations can help support healthcare workers caring for COVID-19 patients.

A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus(2019-nCoV) infected pneumonia(standard version)

In December 2019, a new type viral pneumonia cases occurred in Wuhan, Hubei Province;and then named "2019 novel coronavirus(2019-nCoV)" by the World Health Organization(WHO) on 12 January 2020. For it is a never been experienced respiratory disease before and with infection ability widely and quickly, it attracted the world’s attention but without treatment and control manual. For the request from frontline clinicians and public health professionals of 2019-nCoV infected pneumonia management, an evidence-based guideline urgently needs to be developed. Therefore, we drafted this guideline according to the rapid advice guidelines methodology and general rules of WHO guideline development;we also added the first-hand management data of Zhongnan Hospital of Wuhan University. This guideline includes the guideline methodology, epidemiological characteristics, disease screening and population prevention, diagnosis, treatment and control(including traditional Chinese Medicine), nosocomial infection prevention and control, and disease nursing of the 2019-nCoV. Moreover, we also provide a whole process of a successful treatment case of the severe 2019-nCoV infected pneumonia and experience and lessons of hospital rescue for 2019-nCoV infections. This rapid advice guideline is suitable for the first frontline doctors and nurses, managers of hospitals and healthcare sections, community residents, public health persons, relevant researchers, and all person who are interested in the 2019-nCoV.

新型冠状病毒(2019-nCoV)感染的肺炎诊疗快速建议指南(完整版)

2019新型冠状病毒(2019 novel coronavirus,2019-nCoV)感染的肺炎,因2019年12月发生在武汉的不明原因病毒性肺炎病例而被发现,并于2020年1月12日被世界卫生组织(World Health Organization,WHO)命名。在之后的一个月时间内,2019-nCoV在湖北省内外甚至其他国家传播造成了数以千计的病例出现,同时也引起了民众一定程度的恐慌。本指南的制订希望能够从疾病流行病学、病因学、诊断、治疗、护理、医院感染控制等方面给临床医生、社区居民等提供医疗护理及居家照护相关指导。

新型冠状病毒肺炎药物预防、诊断、治疗与出院管理临床指南计划书

本计划书为《新型冠状病毒(2019-nCoV)感染的肺炎诊疗快速建议指南(标准版)》更新版的研究方案。计划书涵盖指南制定方法学、指南的目标用户、指南的目标人群、利益冲突调查与声明、临床问题和结局指标的遴选与确定、证据的检索、合成与评价、证据与推荐意见分级标准、推荐意见的形成、指南的更新,并附录指南临床问题清单、文献检索策略及利益冲突调查表。

新型冠状病毒院内感染调研与分析工具的开发与验证

目的制定2019-nCoV院内感染调研与分析工具,并行初步验证。方法研究小组基于前期循证制定的"新型冠状病毒医护感染过程及防控调研问卷",主要通过细化问卷调研目的、建立问卷条目池、评估问卷的效度三个步骤进行改编。结果形成了新型冠状病毒院内感染调研与分析工具,包括行政后勤感染组、医护对照组、行政后勤对照组3个问卷。问卷内容与研究目标具有较高的一致性。行政后勤感染组问卷包括"确诊前"、"确诊后"2个领域的调查,其中,"确诊前"涉及感染原因分析、确诊前防控方案、确诊前防控知识、确诊前心理上对疫情的应对状态4个部分,共计16个条目;"确诊后"包括确诊后症状、确诊后治疗、感染后对周围环境和人造成的影响、确诊后心理、感染后防护认识5个方面,共计21个条目。医护对照组问卷涉及与是否感染有关的工作或生活行为、防控相关行为、防控相关知识、心理上对疫情的应对状态4个方面,共计29个条目。行政后勤对照组问卷涉及的领域与医护对照组问卷相同,共计20个条目。结论本研究完成了2019-nCoV院内感染调研与分析工具的制定,共涉及2019-nCoV感染医院非医护工作人员感染过程及防控调研——行政、后勤人员专用,2019-nCoV感染医护感染对照组调研问卷——医护对照组,2019-nCoV感染医护感染对照组调研问卷——行政后勤对照组3个问卷,问卷的信度和效度均可靠、可行性良好。