新疫苗纳入国家免疫规划的评价维度及指标分析

目的 对新疫苗纳入国家免疫规划涉及的决策要素相关的文献进行系统梳理。方法 通过8个中英文文献数据库检索国内外相关文献,归纳各国进行免疫决策时的评价维度及核心指标等。结果 纳入41篇文献,内容以案例研究为主,实证研究较少。各文献基本遵循疾病、疫苗、卫生系统的评价框架,但有不同程度的延伸。疾病死亡率、疫苗安全性及有效性、成本效果评价等为高频评价指标。本研究梳理出基于“疾病-疫苗-能力-效益评价”的4维度13个要素43个指标的评价体系。结论 国内外关于疫苗决策的研究处于发展阶段,我国应增强疫苗纳入免疫规划的评价框架的可操作性及广度,注重本土的流行病学、卫生经济学数据收集,进一步发挥国家免疫规划技术工作组在疫苗循证决策中的作用。     

Meta分析在疫苗评价中的应用

通过Meta分析在疫苗评价中应用的意义、范围、基本步骤和方法等方面的介绍,指导对疫苗的有效性、安全性和经济学等方面的科学评价,为制定疫苗应用策略提供最佳和最新的科学证据,获得更好的疫苗预防和控制传染病的效果,并促进循证疫苗学的发展。     

预防用疫苗临床试验安全性分析和报告的考虑

预防用疫苗(疫苗)的安全性是临床试验重点关注和评价的内容之一。本文结合近年来疫苗注册试验的审评实践,汇总了安全性分析和报告中的常见问题并相应提出系列思考和建议,包括探讨了安全性分析中统计学的作用,提出了安全性分析和报告的框架,涉及分析内容、分析指标和分析维度,其中关注了严重程度的分析;强调安全性风险信号应主动分析,鼓励基于循证的要求开展安全性评价;同时就说明书中收载安全性研究信息的基本原则、以及各期试验及不同受试者安全性数据综合考虑的问题进行了探讨,供疫苗注册申请人参考和借鉴,以促进我国疫苗临床研发和评价。     

新型冠状病毒疫苗对新型冠状病毒德尔塔变异株预防效果的Meta分析

目的 运用循证医学Meta分析方法,探究和评价新型冠状病毒疫苗对新型冠状病毒德尔塔变异株的预防效果,为新冠肺炎的防控提供循证支持。方法 以新型冠状病毒德尔塔毒株、疫苗及其同义词、近义词作为检索词,系统检索中国知网、万方数据库、维普数据库、中国生物医学文献服务系统、PubMed、考科蓝图书馆、Web of Science、BioRxiv、MedRxiv和Europe PMC关于新型冠状病毒疫苗保护效果(Vaccine Effectiveness,VE)的文献,使用纽卡斯尔-渥太华风险评分量表对纳入的队列研究和病例对照研究文献进行质量评价,对纳入的随机对照试验则使用Jadad评分进行质量评价,运用Stata 12.0进行异质性检验、总效应值和发表性偏倚估计。结果 共纳入文献14篇,其中病例对照研究文献5篇,队列研究文献8篇,随机对照实验1篇。Meta分析显示,接种一剂新冠疫苗的合并VE(95%CI)为34.57%(95%CI:21.70%～47.44%),接种两剂新型冠状病毒疫苗的合并VE(95%CI)为70.56%(95%CI: 64.29%～76.82%)。漏斗图分析表明存在发表偏倚风险。结论 接种新型冠状病毒疫苗对预防新型冠状病毒德尔塔变异株有保护作用,且2剂疫苗保护作用明显比1剂疫苗强。后续仍需要收集更多的疫苗保护率研究,提供发表性偏倚风险小的证据。     

口服轮状病毒活疫苗罗特威保护效果及安全性Meta分析

目的评价口服轮状病毒活疫苗罗特威的流行病学保护效果及其安全性,为罗特威的使用提供循证医学依据。方法检索2001-2014年公开发表的符合入选标准的有关罗特威的中文文献,使用Re Man 5.0软件进行统计分析。结果共纳入18篇文献,其中保护效果研究13篇,轮状病毒胃肠炎（rotavirus gastroenteritis,RVGE）、严重轮状病毒胃肠炎（severe RVGE,SRVGE）、RVGE住院率（admission rate,AR）的保护率分别为68%（95%CI:58%75%）、69%（95%CI:52%80%）、61%（95%CI:47%72%）（P<0.001）,平均患病时间减少1.31 d（95%CI:-1.84-0.78）（P<0.001）;7篇文献报道了疫苗安全性,总体不良反应率在1.12%12.77%,合计不良反应率为3.66%。结论罗特威具有良好的流行病学保护效果和安全性,并对发病者具有减轻病情作用。     

乙型肝炎疫苗预防接种安全性综述

通过分析国内外文献中的乙型肝炎疫苗预防接种不良反应,尤其是多发性硬化症、白血病、自身免疫缺陷疾病、死亡等严重不良反应,评价乙型肝炎疫苗的安全性。     

临床教学医院循证医学教育理论应用评价

目的:对临床教学医院临床医生循证医学教育的教学效果进行评价。方式:通过40名临床医生的问卷调查来进行评价。评价指标包括对循证医学有清晰的了解,对循证医学有正确态度,熟悉专业知识更新的方法和途径,具备循证医学应用能力。结果与结论:循证医学教育在临床教学医院取得了良好的教学效果。     

新生儿疾病筛查的安全性和有效性评价

目的　评价影响新生儿疾病筛查安全性与有效性的因素 ,为构建新生儿疾病筛查管理机制提供依据。方法　运用循证医学的理念 ,采用文献归纳方法对新生儿疾病筛查的安全性和有效性进行评价。结果　新生儿疾病筛查技术具有很高的安全性 ,但影响有效性的环节和因素很多 ,文献中报道的采血时间、检测方法、切值水平、效果评价指标等方面均存在一定差异 ,有效性令人忧虑。结论　重视对筛查技术安全性的认识和评价 ;加强对筛查技术有效性的系统研究     

我国疫苗上市后规范化评价的现状与对策

疫苗在上市前,通过临床试验,疫苗安全性和有效性得到规范评估。但由于上市前临床试验存在观察时间短、观察对象少等因素限制,罕见的严重预防接种异常反应、流行病学保护效果、免疫持久性和卫生经济学等方面,都难以做出确切评价。另外,大规模生产的疫苗上市后,其质量稳定性也待进一步验证。因此,开展疫苗上市后的规范化评价,对于完善和调整疫苗的免疫策略是非常重要的。现就我国疫苗上市后评价文献中存在的有关伦理、试验设计、实验方法、疾病诊断、安全性监测、统计学等方面问题进行剖析,并提出相应对策。     

本期专栏导语

正以证据为中心的循证疫苗免疫策略制定(evidence-based strategy making)这一概念,正受到疫苗策略制定研究者和公共卫生决策者的关注。本期专栏围绕循证疫苗免疫策略这一主题,从循证路径与方法、策略实施保障、策略运行后评价等方面为广大读者提供了科学和丰富的研究内容,特别是对中国未     

Methodological changes implemented over time to support accurate and timely COVID-19 vaccine coverage estimates: Ontario,Canada

AbstractThe COVID-19 vaccination program implementation in Ontario, Canada has spanned multiple years and is ongoing. To meet the challenges of the program, Ontario developed and implemented a new electronic COVID-19 immunization registry, COVaxON, which captures individual-level data on all doses administered in the province enabling comprehensive coverage assessment. However, the need for ongoing COVID-19 vaccine coverage assessments over a multi-year vaccination program posed challenges necessitating methodological changes. This paper describes Ontario’s COVID-19 immunization registry, the methods implemented over time to allow for the ongoing assessment of vaccine coverage by age, and the impact of those methodological changes.Throughout the course of the vaccination program, four different methodological approaches were used to calculate age-specific coverage estimates using vaccination data (numerator) obtained from COVaxON. Age-specific numerators were initially calculated using age at time of first dose (method A), but were updated to the age at coverage assessment (method B). Database enhancements allowed for the exclusion of deceased individuals from the numerator (method C). Population data (denominator) was updated to 2022 projections from the 2021 national census following their availability (method D). The impact was most evident in older age groups where vaccine uptake was high. For example, coverage estimates for individuals aged 70–79 years of age for at least one dose decreased from 104.9 % (method B) to 95.0 % (method D). Thus, methodological changes improved estimates such that none exceeded 100 %.Ontario’s COVID-19 immunization registry has been transformational for vaccine program surveillance. The implementation of a single registry for COVID-19 vaccines was essential for comprehensive near real-time coverage assessment, and enabled new uses of the data to support additional components of vaccine program surveillance. The province is well positioned to build on what has been achieved as a result of the COVID-19 pandemic and expand the registry to other routine vaccination programs.     

Developing product label information to support evidence-informed use of vaccines in pregnancy

BackgroundProduct labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.PurposeTo develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.MethodsWe conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus.Principal resultsStakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada.ConclusionsThe revised statements for IIV and Tdap aligned with workshop participants’ goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.     

精神卫生领域患者安全中外研究对比分析

目的对比分析精神卫生领域患者安全中外研究主题,以期对我国该领域研究发展提供参考。 方法检索中国知网（CNKI）、万方和PubMed数据库,获取精神卫生领域患者安全中外文文献,采用VOSviewer软件并借助Excel 2016软件对纳入文献的发表年份、来源期刊、作者及合作网络、关键词等进行计量学分析。结果最终纳入810篇中文文献,1 427篇外文文献。中文文献包含老年、安全隐患及应对措施、住院安全及风险控制、精神分裂患者、不良事件管理5个主题;外文文献包含医务人员临床工作及沟通能力,老年,儿童、青少年及成人住院与出院患者自伤、自杀,住院患者安全4个主题。结论精神卫生领域中外文文献共同研究热点为老年及住院患者安全。外文文献主题涉及较宽泛,全方位探索了针对性干预方式;而中文文献研究内容较笼统,研究结果缺乏针对性,有较大发展空间。     

National decision-making for the introduction of new vaccines: A systematic review, 2010–2020

BackgroundCompeting priorities make using a transparent and evidence-based approach important when deciding to recommend new vaccines. We conducted a literature review to document the processes and frameworks for national decision-making on new vaccine introductions and explored which key features have evolved since 2010.MethodsWe searched literature published on policymaking related to vaccine introduction from March 2010 to August 2020 in six databases. We screened articles for eligibility with the following exclusion criteria: non-human or hypothetical vaccines, the sole focus on economic evaluation or decision to adopt rather than policy decision-making. We employed nine broad categories of criteria from the 2012 review for categorization and abstracted data on the country, income level, vaccine, and other relevant criteria.ResultsOf the 3808 unique references screened, 116 met eligibility criteria and were classified as: a) framework of vaccine adoption decision-making (27), b) studies that analyse empirical data on or examples of vaccine adoption decision-making (45), c) theoretical and empirical articles that provide insights into the vaccine policymaking process (44 + 17 already included in the previous categories). Commonly reported criteria for decision-making were the burden of disease; vaccine efficacy/effectiveness, safety; impact on health and non-health outcomes; economic evaluation and cost-effectiveness of alternative interventions. Programmatic and acceptability aspects were not as often considered. Most (50; 82%) of the 61 articles describing the process of vaccine introduction policymaking highlighted the role of country, regional, or global evidence-informed recommendations and a robust national governance as enabling factors for vaccine adoption.ConclusionsThe literature on vaccine adoption decision-making has expanded since 2010. We found that policymakers and expert advisory committee members (e.g., National Immunization Technical Advisory Group [NITAG]) increasingly value the interventions based on economic evaluations. The results of this review could guide discussions on evidence-informed immunization decision-making among country, sub-regional, and regional stakeholders.     

Yellow fever vaccine usage in the United States and risk of neurotropic and viscerotropic disease: A retrospective cohort study using three healthcare databases

BackgroundYellow fever (YF) vaccines are highly effective and have a well-established safety profile despite the risk of rare serious adverse events (SAEs), vaccine-associated neurotropic (YEL-AND) and viscerotropic disease (YEL-AVD). This study aimed to describe US civilian YF vaccine usage, the population characteristics and pre-existing immunosuppressive medical conditions among those vaccinated, and to provide updated risk estimates of neurotropic and viscerotropic disease post-vaccination.MethodsA retrospective cohort study was conducted using de-identified patient information from Optum Electronic Healthcare Record (EHR) (2007–2019), Optum Clinformatics Data Mart (CDM) (2004–2019) and IBM MarketScan (2007–2019) databases. YF vaccine recipients were identified using relevant vaccination and procedural codes. Demographic characteristics and pre-existing medical conditions were described. Incidence proportions with 95% confidence intervals (CI) of neurotropic and viscerotropic diseases occurring ≤ 30 days post-vaccination, after exclusion of unlikely cases based on current clinical guidelines of YEL-AND and YEL-AVD, were calculated.ResultsA total of 92,205, 46,539 and 125,235 YF vaccine recipients were retrieved from Optum EHR, Optum CDM and IBM MarketScan databases, respectively. The majority of vaccine recipients were aged < 60 years (highest proportion aged 18–29 years) with a higher proportion of females overall. Few vaccine recipients (<1%) had conditions predisposing them to immunosuppression. Four non-fatal cases of neurotropic disease and zero cases of viscerotropic disease were identified. The incidence proportion of post-vaccination neurotropic disease was 1.41 (95% CI: 0.15–6.61) and 3.04 (95% CI: 0.86–8.11) per 100,000 vaccine recipients in Optum EHR and IBM MarketScan, respectively, with no events identified in Optum CDM.ConclusionsThis study provides updated insights into current YF vaccine usage in US civilian recipients and supports the safety profile of YF vaccines in US practice. The low frequency of pre-existing immunosuppressive medical conditions among vaccine recipients suggests good adherence to vaccination guidelines by healthcare practitioners. The risk of developing neurotropic and viscerotropic disease post-vaccination remains rare.     

Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review

BackgroundRapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed.MethodsWe conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185).ResultsWe retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.     

Partial updating of clinical practice guidelines often makes more sense than full updating: a systematic review on methods and the development of an updating procedure

ObjectivesTo conduct a systematic review of the methods used to determine when and how to update clinical practice guidelines (CPGs) and develop a procedure for updating CPGs.Study Design and SettingWe searched MEDLINE, Embase, and the Cochrane Methodology Register for methodological publications on updating CPGs. Guideline development manuals were obtained from the Web sites of guideline-developing organizations. Using the information obtained from these records, a procedure for updating CPGs was developed.ResultsA total of 5,116 journal articles were screened, and seven articles met the criteria for inclusion. Forty-seven manuals were included; of these, eight included details about the methods used to update the guidelines. Most of the included publications focused on assessing whether the CPGs needed updating and not on how to update them. The developed procedure includes a systematic monitoring system and a scheduled process for updating the CPGs, which includes guidance on how to determine the type and scope of an update.ConclusionPartial updating often makes more sense than updating the whole CPG because topics and recommendations differ in terms of the need for updating. Guideline developers should implement a systematic updating procedure that includes an ongoing monitoring system that is appropriate for the nature of the guideline topics and the capabilities of the developers.     

红外耳温计测量老年人体温准确性的Meta分析

目的 系统评价红外耳温计测量老年人体温的准确性。方法 计算机检索PubMed、Cochrane图书馆、Embase、中国期刊全文数据库（CNKI）、维普中文科技期刊数据库以及万方数据库中1988-2019年关于红外耳温计测量老年人体温准确性的文献，正在进行的研究通过ClinicalTrials.gov进行搜索。严格按照纳入和排除标准筛选文献，提取资料，评价纳入研究的偏倚风险，使用Stata12.0软件进行统计分析。结果 最终纳入8篇文献，其中3篇有体温正常组和发热组患者体温均数和标准差，1篇有发热组耳温与腋温数据的比较，4篇仅有正常组耳温与腋温数据的比较；5篇文献比较了左耳与右耳耳温的数据。Meta分析结果显示，耳温与腋温比较，体温正常组、发热组差异均无统计学意义（均P>0.05）；左耳与右耳耳温比较，差异无统计学意义（P>0.05）。结论 红外耳温计准确性良好，可作为确定老年人初始温度的最佳筛选工具。     

COVID-19 vaccine safety inquiries to the Centers for Disease Control and Prevention Immunization Safety Office

BackgroundFollowing the authorization and recommendations for use of the U.S. COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC)’s Immunization Safety Office (ISO) responded to inquiries and questions from public health officials, healthcare providers, and the general public on COVID-19 vaccine safety.MethodsWe describe COVID-19 vaccine safety inquiries, by topic, received and addressed by ISO from December 1, 2020–August 31, 2022.ResultsOf the 1978 COVID-19 vaccine-related inquiries received, 1655 specifically involved vaccine safety topics. The most frequently asked-about topics included deaths following vaccination, myocarditis, pregnancy, and reproductive health outcomes, understanding or interpreting data from the Vaccine Adverse Event Reporting System (VAERS), and thrombosis with thrombocytopenia syndrome.ConclusionsInquiries about vaccine safety generally reflect issues that receive media attention. ISO will continue to monitor vaccine safety inquiries and provide accurate and timely information to healthcare providers, public health officials, and the general public.