Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic

BackgroundThe COVID-19 pandemic caused an abrupt drop in in-person health care (inpatient, Emergency Department, outpatient) and an increase in telehealth care, which poses challenges in vaccine safety studies that identify outcomes from in-person encounters. We examined the changes in incidence rates of selected encounter-based outcomes during the COVID-19 pandemic.MethodsWe assembled a cohort of members from 8 Vaccine Safety Datalink sites from January 1, 2017 through December 31, 2020. Using ICD-10 diagnosis codes or laboratory criteria, we identified 21 incident outcomes in traditional in-person settings and all settings. We defined 4 periods in 2020: January-February (pre-pandemic), April-June (early pandemic), July-September (middle pandemic), and October-December (late pandemic). We defined four corresponding periods in each year during 2017–2019. We calculated incidence rates, conducted difference in difference (DiD) analyses, and reported ratios of incidence rate ratios (RRR) to examine changes in rates from pre-pandemic to early, middle, and late pandemic in 2020, after adjusting for changes across similar periods in 2017–2019.ResultsAmong > 10 million members, regardless of setting and after adjusting for changes during 2017–2019, we found that incidence rates of acute disseminated encephalomyelitis, encephalitis/myelitis/encephalomyelitis/meningoencephalitis, and thrombotic thrombocytopenic purpura did not significantly change from the pre-pandemic to early, middle or late pandemic periods (p-values ≥ 0.05). Incidence rates decreased from the pre-pandemic to early pandemic period during 2020 for acute myocardial infarction, anaphylaxis, appendicitis, Bell’s palsy, convulsions/seizures, Guillain-Barré syndrome, immune thrombocytopenia (ITP), narcolepsy/cataplexy, hemorrhagic stroke, ischemic stroke, and venous thromboembolism (p-values < 0.05). Incidence rates of Bell’s palsy, ITP, and narcolepsy/cataplexy were higher in all settings than in traditional in-person settings during the three pandemic periods (p-values < 0.05).ConclusionRates of some clinical outcomes during the pandemic changed and should not be used as historical background rates in vaccine safety studies. Inclusion of telehealth visits should be considered for vaccine studies involving Bell’s palsy, ITP, and narcolepsy/cataplexy.     

ECFS standards of care on CFTR-related disorders: Updated diagnostic criteria

This paper is the first in a series providing updated guidance on the definition, evaluation and management of people with a Cystic Fibrosis Transmembrane conductance Regulator (CFTR)-Related Disorder (CFTR-RD). The need for this update relates to more precise characterisation of CFTR gene variants and improved assessment of CFTR protein dysfunction. The exercise is co-ordinated by the European CF Society Standards of Care Committee and Diagnostic Network Working Group and involves stakeholder engagement. This first paper was produced by a core group using an extensive literature review and papers graded for their quality. Subsequent wider stakeholder agreement was achieved.The definition of a CFTR-RD remains “a clinical condition with evidence of CFTR protein dysfunction that does not fulfil the diagnostic criteria for CF”. Clearer guidance on CFTR dysfunction and relevant CFTR variants will be provided. Thresholds for clinical presentations are presented and the paradigm that pathobiological processes may be evident in more than one organ is agreed. In this paper we reflect on the early patient journey, highlighting that CF specialists as well as other relevant specialists should be involved in the care of people with a CFTR-RD.     

Prospective assessment of reproducibility of three-dimensional ultrasound for fetal biometry

PurposeTo compare fetal ultrasound measurements performed by two observers with different levels of experience and evaluate the potential contribution of the use of three-dimensional (3D) ultrasound on repeatability, reproducibility and agreement of two-dimensional (2D) and 3D-derived measurements.Materials and methodsTwo observers (one senior and one junior) measured head circumference (HC), abdominal circumference (AC) and femur length (FL) in 33 fetuses (20 to 40 weeks of gestation). Each observer performed two series of 2D measurements and two series of 3D measurements (i.e., measurements derived from triplane volume processing). Measurements were converted into Z-scores according to gestational age. Variability between the different series of measurements was studied using Bland–Altmann plots and intra-class correlation coefficients (ICC).ResultsAgreement with the 2D measurements of the senior observer was higher in 3D than in 2D for the junior observer (systematic differences of −0.4, −0.2 and −0.8 Z-score vs. −0.1, −0.1 and −0.6 for HC, AC and FL on 2D and 3D datasets, respectively). The use of 3D ultrasound improved junior observer repeatability (ICC = 0.94, 0.88, 0.90 vs. 0.94, 0.94 and 0.96 for HC, AC and FL in 2D and 3D, respectively). The reproducibility was greater using the junior observer 3D datasets (ICC = 0.75, 0.60 and 0.45 vs. 0.79, 0.89 and 0.63 for HC, AC and FL, respectively).ConclusionThe use of 3D ultrasound improves the consistency of the measurements performed by a junior observer and increases the overall repeatability and reproducibility of measurements performed by observers with different levels of experience.     

A multiple reader scoring system for Nasal Potential Difference parameters

Background

Nasal Potential Difference (NPD) is a biomarker of CFTR activity used to diagnose CF and monitor experimental therapies. Limited studies have been performed to assess agreement between expert readers of NPD interpretation using a scoring algorithm.

脑梗死正常、病变区ADC差值对出血性转化风险的评估价值

目的研究脑梗死正常、病变区表观弥散系数差值对出血性转化风险的评估价值。方法选取我院2014年7月-2016年6月神经内科收治的50例早期脑梗死患者,入院后给予螺旋CT和MRI常规颅脑平扫,所有患者均行DWI、ADC扫描,在患者MR ADC图上分别测量并计算脑梗死正常区、病变区的ADC差值;发病2周后随访行MR复查,观察HT发生情况,并进一步分析HT和ADC差值的相关性。结果通过随访复查,50例CI患者中共有5例出现HT,未发生HT(NHT)为45例,HT发病率为10.0%,低于未发生HT(NHT)比重90.0%;早期ADC差值测量显示5例明显205.5×10-6mm2/s,且与随访复查出现HT的5例患者完全吻合,ADC差值预测体现较好的准确度和特异性;HT患者ADC差值(221.4±10.2)×10-6mm2/s高于NHT(145.3±11.4)×10-6mm2/s,差异显著(P0.05)。结论早期脑梗死正常、病变区ADC差值测量能较好的反映梗死灶出血状况,本次研究认为当ADC差值205.5×10-6mm2/s即提示HT发生的高风险可能,对临床预测评估HT和指导治疗具有较高的参考价值。     

儿童支气管哮喘急性发作临床特征及其年龄差异分析

目的 探讨儿童支气管哮喘急性发作及不同年龄发作的特点,以预防及控制其发作。方法 收集2013年1月~2015年12月笔者医院哮喘急性发作住院患儿395例,分成<5岁组和≥5岁组两组,对患儿的一般资料、流行病学、诱发因素、呼吸道感染及病原谱、过敏原、并发症进行比较分析。结果 入组病例平均年龄4.25±2.51岁,男女性别比例为2.06：1,住院高峰季节为秋季,合并呼吸道感染367例（92.91%）,入院前已确诊哮喘113例（28.61%）,长期规范治疗随访31例（7.85%）。与≥岁组比较,<5岁组易合并呼吸道感染（χ²=9.856,P=0.007）,且更易合并肺炎（χ²=9.846,P=0.002）。<5岁组呼吸道合胞病毒检出率明显增高（χ²=10.870,P=0.001）,但支原体感染检出率两组之间比较,差异无统计学意义（χ²=3.090,P=0.079）。并且<5岁组住院前诊断哮喘率（χ²=16.742,P=0.000）、长期规范治疗随访率（χ²=12.948,P=0.000）均明显低于≥5岁组。结论 呼吸道感染、未早期规范诊治是儿童支气管哮喘急性发作主要诱因。<5岁幼儿哮喘急性发作更易并发呼吸道感染,易合并肺炎及呼吸合胞病毒感染,并且住院前诊断率及长期规范治疗依从性均较低。     

模糊状态风险分析的广义Logistic 回归理论与应用(1)

论述了“微弱相关影响因素”概念及其在预防医学中的重要意义,并研究了适宜处理此类资料的统计方法。借助模糊状态概念、交叉积差和统计量和信息量寻优标准,发展了暴露水平聚类优化、状态变量选择通用算法,可明显提高检测、识别微弱相关影响因素的效能与统计分析水准     

人参不同药用部位皂苷类成分差异性分析

目的:探讨人参不同药用部位（人参、人参叶、人参花）中皂苷类成分的差异性,为其质量评定提供参考。方法:采用超高效液相色谱-串联四级杆飞行时间高分辨质谱（UFLC-Triple-TOF-MS/MS）分析人参、人参叶、人参花中皂苷类成分含量,采用SynergiTM Hydro-RP 100 A柱,0.1%甲酸水溶液（A）-乙...     

社区残疾人药学服务需求现状及差异性研究

背景 残疾人群是多种疾病的高发人群,目前对于其医疗服务需求的研究多集中在定期体检、上门服务、康复指导等方面,而针对其药学服务需求的研究相对较少。目的 了解社区残疾人的药学服务需求,基于基本人口学特征、社会经济地位、残疾类别和残疾等级探讨其药学服务差异。方法 于2017年11—12月,采用单纯随机抽样法在上海市某街道的在册残疾人中抽取230例进行问卷调查。主要内容包括：残疾人的基本人口学特征（性别、年龄、婚姻状况）、社会经济地位（文化程度、工作状态、家庭人均月收入）、残疾类别与残疾等级、药学服务需求（需求内容、需求来源、需求程度）。结果 共回收有效问卷226份（98.3%）。残疾人的药学服务需求内容排在前2位的为“用法用量及疗程”（73.0%,165/226）、“适应证和禁忌证”（51.3%,116/226）;需求来源主要为医生（85.4%,193/226）;需求程度为非常/比较需要者占48.2%（109/226）。在需求内容上,不同工作状态者对“药品说明书解读”服务的需求率比较,差异有统计学意义（P<0.05）;不同家庭人均月收入者对“用法用量及疗程”服务的需求率比较,差异有统计学意义（P<0.05）。在需求来源上,不同年龄、工作状态、残疾等级者对由医生提供药学服务的需求率比较,差异有统计学意义（P<0.05）;不同年龄者对通过媒体获得药学服务的需求率比较,差异有统计学意义（P<0.05）。在需求程度上,不同文化程度、工作状态、残疾类别、残疾等级者对药学服务的需求程度比较,差异有统计学意义（P<0.05）。结论 不同情况残疾人的药学服务需求内容差异性不大,但需求来源、需求程度差异性较大,尤其是需求程度。社区药师应采用多种形式对残疾人开展用药宣教和个性化药学服务。