Leite Andreia, Andrews Nick J, Thomas Sara L
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Statistics, Modelling and Economics Department, Public Health England, London, UK.
Pharmacoepidemiol Drug Saf. 2017 Apr;26(4):437-445. doi: 10.1002/pds.4173. Epub 2017 Feb 3.
PURPOSE: Near real-time vaccine safety surveillance (NRTVSS) is an option for post-licensure vaccine safety assessment. NRTVSS requires timely recording of outcomes in the database used. Our main objective was to examine recording delays in the Clinical Practice Research Datalink (CPRD) for outcomes of interest for vaccine safety to inform the feasibility of NRTVSS using these data. We also evaluated completeness of recording and further assessed reporting delays for hospitalized events in CPRD. METHODS: We selected Guillain-Barré syndrome (GBS), Bell's palsy (BP), optic neuritis (ON) and febrile seizures (FS), from January 2005 to June 2014. We assessed recording delays (e.g. due to feedback from specialist referral) in stand-alone CPRD by comparing the event and system dates and excluding delays >1 year. We used linked CPRD-hospitalization data to further evaluate delays and completeness of recording in CPRD. RESULTS: Among 51 220 patients for the stand-alone CPRD analysis (GBS: n = 830; BP: n = 12 602; ON: n = 1720; and FS: n = 36 236), most had a record entered within 1 month of the event date (GBS: 73.6%; BP: 93.4%; ON: 76.2%; and FS: 85.6%). A total of 13 482 patients, with a first record in hospital, were included for the analysis of linked data (GBS: n = 678; BP: n = 4060; ON: n = 485; and FS: n = 8321). Of these, <50% had a record in CPRD after 1 year (GBS: 41.3%; BP: 22.1%; ON: 22.4%; and FS: 41.8%). CONCLUSION: This work shows that most diagnoses in CPRD for the conditions examined were recorded with delays of ≤30 days, making NRTVSS possible. The pattern of delays was condition-specific and could be used to adjust for delays in the NRTVSS analysis. Despite low sensitivity of recording, implementing NRTVSS in CPRD is worthwhile and could be carried out, at least on a trial basis, for events of interest. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.
目的:近实时疫苗安全性监测(NRTVSS)是上市后疫苗安全性评估的一种选择。NRTVSS要求在所使用的数据库中及时记录结果。我们的主要目标是检查临床实践研究数据链(CPRD)中与疫苗安全性相关的感兴趣结果的记录延迟情况,以了解使用这些数据进行NRTVSS的可行性。我们还评估了记录的完整性,并进一步评估了CPRD中住院事件的报告延迟情况。 方法:我们选取了2005年1月至2014年6月期间的吉兰 - 巴雷综合征(GBS)、贝尔麻痹(BP)、视神经炎(ON)和热性惊厥(FS)。我们通过比较事件日期和系统日期,并排除超过1年的延迟,评估独立CPRD中的记录延迟(例如由于专科转诊的反馈)。我们使用CPRD与住院数据的关联来进一步评估CPRD中的延迟和记录完整性。 结果:在用于独立CPRD分析的51220例患者中(GBS:n = 830;BP:n = 12602;ON:n = 1720;FS:n = 36236),大多数患者在事件日期后的1个月内有记录录入(GBS:73.6%;BP:93.4%;ON:76.2%;FS:85.6%)。共有13482例首次在医院有记录的患者被纳入关联数据的分析(GBS:n = 678;BP:n = 4060;ON:n = 485;FS:n = 8321)。其中,1年后CPRD中有记录的患者不到50%(GBS:41.3%;BP:22.1%;ON:22.4%;FS:41.8%)。 结论:这项工作表明,CPRD中所检查病症的大多数诊断记录延迟≤30天,这使得NRTVSS成为可能。延迟模式因病症而异,可用于在NRTVSS分析中调整延迟。尽管记录的敏感性较低,但在CPRD中实施NRTVSS是值得的,并且至少可以在试验基础上针对感兴趣的事件进行。© 2017作者。药物流行病学与药物安全。由John Wiley & Sons Ltd出版。
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