Agreement between medical record and parent report for evaluation of childhood febrile seizures

Background

The monitoring of vaccine safety is critical to maintaining the public acceptance of vaccines required to ensure their continued success. Methods used to assess adverse events following immunization (AEFI) must accurately reflect their occurrence. Assessment of AEFI is often done via medical record review (MR) or via patient report (PR). However, these sources of data have not previously been compared for the analysis of AEFI. The objective of this study was to evaluate the concordance between MR and PR for young children identified as having had a febrile seizure (FS), an important AEFI, in an integrated health care system. The variables chosen for analysis were those recommended by the Brighton Collaboration Seizure Working Group for the evaluation of generalized seizure as an AEFI [1].

Methods

Parent report from phone interviews and mailed questionnaires was compared to abstracted medical records of 110 children with FS between ages 3 and 60 months. Concordance between PR and MR for characteristics and predisposing factors of FS was assessed by percent total agreement and kappa statistic.

Results

Percent total agreement between PR and MR was between 43.6 and 100% for variables studied, with 62.5% of items having >70% agreement. However, kappa was poor to fair for all measures (−0.04 to 0.33). While some variables, such as history of seizures in a sibling or parent and several seizure characteristics, were reported more often by PR, other items, such as maximum fever and several concurrent conditions, were reported more often by MR.

Conclusion

These findings demonstrate the limitations of using MR or PR alone to assess febrile seizures in children. This analysis supports the practice of collecting data from both MR and PR to most accurately portray the spectrum of predisposing factors and seizure characteristics when evaluating FS in children whenever feasible.     

2010年成都市麻疹减毒活疫苗强化免疫异常反应分析

目的分析成都市2010年麻疹减毒活疫苗(Measles Attenuated Live Vaccine,MV)强化免疫活动的预防接种异常反应发生特征,探讨MV强化免疫活动的安全性及减少预防接种异常反应的措施。方法对成都市2010年麻疹减毒活疫苗强化免疫活动的预防接种异常反应的资料进行分析。结果成都市2010年MV强化免疫活动共报告57例预防接种异常反应,发生率为128.9/100万剂次;男性多于女性,0岁组异常反应发生率最高,随年龄增大异常反应发生率逐渐降低;接种后<2 d出现反应的占71.93%;临床损害以过敏性皮疹为主,绝大多数病例预后良好。结论 MV强化免疫活动的预防接种异常反应发生率低,各年龄组儿童在接种MV后<2 d是监测的重点。应加强监测,提高预防接种异常反应的预防和处理水平。     

麻疹疫苗强化免疫疑似预防接种异常反应监测

目的:对麻疹强化免疫中发生的疑似预防接种异常反应(AEFI)的原因进行分析和探讨,不断总结经验,正确认识AEFI问题,采取正确处理措施.方法:采用描述性流行病学方法对监测数据进行分析.结果:麻疹疫苗强化免疫共接种113622人,报告AEFI31例,总体报告发生率27.28/10万,其中一般反应11例(占35.48%),...     

江苏省海安县2008-2009年疑似预防接种反应监测分析

目的对预防接种过程中使用的一、二类疫苗发生疑似预防接种异常反应（AEFI）发生率进行监测,评价疫苗的安全性和预防接种服务质量。方法利用儿童预防接种信息管理系统AEFI管理模块,收集一、二类疫苗疑似预防接种异常反应信息进行分析。采用SPSS 10.0统计软件,率的比较用χ2检验,P〈0.05为差异有统计学意义。结果 2008-2009年共接种疫苗53.4万剂次,报告AEFI 184例,报告发生率34.44/10万。AEFI发生率位于前三位的是无细胞百白破、23价肺炎、B型流感嗜血杆菌结合疫苗（Hib）,该3种疫苗AEFI报告发生数占总报告数的51.09%。反应分类集中在一般反应,占86.96%。预防接种副反应以常规免疫接种儿童为主,主要集中在3~9月份,89.47%发生在接种24 h内,经对接种第一针次发生一般反应与异常等反应进行统计学分析,χ2=2.3232,P〉0.05,差异无统计学意义。结论本调查表明,发生AEFI因素多种多样,要改进疫苗制备工艺,提高业务人员的综合素质,严格掌握疫苗禁忌症,规范接种流程能减少AEFI的发生。     

2012 - 2015年张家港市疑似预防接种异常反应监测分析

目的 分析2012 - 2015年张家港市疑似预防接种异常反应（AEFI）的发生情况和特征,评价系统运行情况,以科学指导今后开展AEFI监测工作。方法 通过AEFI信息管理系统收集2012 - 2015年报告的个案数据,采用描述性流行病学研究方法进行分析。结果 2012 - 2015年张家港市报告AEFI病例1 146例,报告发生率64.55 /10万;其中一般反应占94.07%,异常反应占5.58%。男女性别比为1.45∶1,90.40%的AEFI都发生在24 h内;报告数位居前三位的疫苗分别是百白破、白破和麻风疫苗;临床诊断以发热/红肿/硬结为主,占84.64%。结论 AEFI监测系统运行情况正常,可探索开展主动监测,进一步提高全市AEFI监测的质量。     

2015 - 2018年简阳市疑似预防接种异常反应监测分析

目的 分析简阳市2015 - 2018年疑似预防接种异常反应（Adverse Events Following Immunization,AEFI）特征,评价监测系统运转情况及AEFI监测工作质量。方法 通过中国免疫规划信息管理系统收集简阳市2015 - 2018年AEFI数据,采用描述流行病学的方法对监测数据进行统计分析。结果 简阳市2015 - 2018年共报告AEFI个案320例,乡镇覆盖率100%。其中一般反应282例,异常反应33例,偶合症5例。报告发生率为25.95/10万剂,其中一般反应发生率为22.87例/10万剂,异常反应发生率为1.76例/10万剂,无心因性反应、接种事故和疫苗质量事故发生。AEFI病例主要分布在1岁及以下儿童,占41.88%。 接种后1 d内发生的AEFI有281例,占87.81%。 48 h内报告率为99.06%,48 h内调查率100%,个案调查表在调查后3 d内报告率为86.84%,AEFI分类率100%。结论 简阳市2015 - 2018年AEFI报告例数逐年增加,但监测敏感性在成都市所有区县中仍处于较低水平,存在迟报、漏报现象,可通过加强设施设备投入,加强督导考核、培训宣传等方法,进一步提高AEFI监测工作质量。     

Use of a new global indicator for vaccine safety surveillance and trends in adverse events following immunization reporting 2000–2015

Reporting of adverse events following immunization (AEFI) is a key component for functional vaccine safety monitoring system. The aim of our study is to document trends in the AEFI reporting ratio globally and across the six World Health Organization (WHO) regions. We describe the number of AEFI reports communicated each year through the World Health Organization/United Nations Children's Fund Joint Reporting Form on Immunization from 2000 to 2015. The AEFI reporting ratios (annual AEFI reports per 100,000 surviving infants) were calculated to identify WHO countries (n = 191 in 2000 and n = 194 by 2015) that met a minimal reporting ratio of 10, a target set by the Global Vaccine Action Plan for vaccine safety monitoring as a proxy measure for a functional AEFI reporting system. The number of countries reporting any AEFI fluctuated over time but with progress from 32 (17%) in 2000 to 124 (64%) in 2015. In 2015, the global average AEFI reporting ratio was 549 AEFI reports per 100,000 surviving infants. The number of countries with AEFI reporting ratios greater than 10 increased from 8 (4%) in 2000 to 81 (42%) in 2015. In 2015, 60% of countries in the WHO Region of the Americas reported at least 10 AEFI per 100,000 surviving infants, followed by 55% in European Region, 43% in Eastern Mediterranean Region, 33% in Western Pacific Region, 27% in South-East Asia Region and 21% in African Region. Overall, AEFI reporting has increased over the past sixteen years worldwide, but requires strengthening in a majority of low- and middle- income countries. The AEFI reporting ratio is useful for benchmarking and following trends over time; but does not provide information on the quality of the reporting system and does not guarantee capacity to detect and manage a vaccine safety problem at a national level. Additional efforts are required to ensure and improve data quality, AEFI reporting and surveillance of immunization safety in every country.     

Vasculitis as an adverse event following immunization – Systematic literature review

BackgroundSeveral types of vasculitis have been observed and reported in temporal association with the administration of various vaccines. A systematic review of current evidence is lacking.ObjectiveThis systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI).MethodsWe reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population.ResultsThe initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis.ConclusionsExisting literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization.     

2016—2020年简阳市疑似预防接种异常反应监测分析

目的分析简阳市2016—2020年疑似预防接种异常反应(adverse event following immuni-zation,AEFI)发生特征,评价预防接种异常反应监测系统运转情况,为AEFI监测工作提供参考依据。方法通过全国AEFI信息管理系统收集简阳市2016—2020年AEFI个案数据,采用描述流行病学的方法进行统计分析。结果2016—2020年简阳市共报告AEFI 622例,报告发生率为46.65/10万剂,简阳市21个乡镇均有AEFI报告,48 h内报告报告率为99.84%,48 h内调查率为98.51%。AEFI报告发生例数≤1岁组占74.60%,接种后0~1 d发生占91.00%,集中发生在5~8月。AEFI分类中一般反应555例,发生率41.63/10万剂;异常反应54例,发生率4.05/10万剂;偶合症13例,发生率0.96/10万剂。AEFI报告发生率居前5位的疫苗分别为DTap-Hib四联疫苗(25.68‰)、23价肺炎球菌疫苗(13.67‰)、百白破(无细胞)疫苗(12.93‰)、含麻疫苗(麻腮风疫苗+麻腮疫苗)(5.46‰)和乙脑减毒活疫苗(3.67‰)。结论2016—2020年简阳市AEFI监测系统运转良好、监测敏感性逐年提高、各类疫苗安全可靠、预防接种服务质量较好,但是AEFI监测报告发生率与实际存在一定偏差,监测数据的敏感性、准确性及监测质量有待进一步提高。