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一项关于在全科诊所候诊室推广流感疫苗接种的随机对照试验的重新分析:一项泽伦设计。

Reanalysis of a Randomized Controlled Trial on Promoting Influenza Vaccination in General Practice Waiting Rooms: A Zelen Design.

作者信息

Berkhout Christophe, De Man Jeroen, Collins Claire, Willefert-Bouche Amy, Zgorska-Maynard Moussa Suzanna, Badelon Margot, Peremans Lieve, Van Royen Paul

机构信息

UFR3S, Department of General Practice/Family Medicine, Lille University, 59045 Lille, France.

Department of Family Medicine and Population Health, University of Antwerp, 2610 Antwerp, Belgium.

出版信息

Vaccines (Basel). 2022 May 23;10(5):826. doi: 10.3390/vaccines10050826.

DOI:10.3390/vaccines10050826
PMID:35632583
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9143687/
Abstract

In 2014-2015, we conducted a randomized controlled trial (RCT) assessing the effect of an advertising campaign for influenza vaccination using posters and pamphlets in general practitioner (GP) waiting rooms. No effect of the intervention could be demonstrated, but the immunization uptake increased in both arms of the study. In 2019, we deepened the investigations explaining the increased uptake conducting a registry-based 4/2/1 cluster RCT designed by Zelen with two extra years of follow-up of the study cohort. The study population included 23,024 patients eligible to be vaccinated who were registered with 175 GPs. The main outcome remained the number of vaccination units delivered per study group. Data were extracted from the SNIIRAM warehouse claim database for the Lille-Douai district (northern France). No difference in vaccination uptake was found in the Zelen versus the control group of the initial RCT. Overall, the proportion of vaccinated patients increased in the cohort from 51.4% to 70.4% over the three years. Being vaccinated the previous year was a strong predictor of being vaccinated in a subsequent year. The increase in vaccination uptake, especially among people older than 65, can be explained by a cohort effect. Health promotion and the promotion of primary health care may play an important role in this increase.

摘要

2014年至2015年,我们进行了一项随机对照试验(RCT),评估在全科医生(GP)候诊室使用海报和宣传册开展流感疫苗接种广告活动的效果。未证明干预措施有效果,但研究的两个组中疫苗接种率均有所提高。2019年,我们深入调查了接种率提高的原因,开展了一项基于登记的4/2/1整群随机对照试验,该试验由泽伦设计,对研究队列进行了另外两年的随访。研究人群包括23,024名有资格接种疫苗且在175名全科医生处登记的患者。主要结局仍然是每个研究组接种疫苗的单位数量。数据从法国北部里尔-杜埃地区的SNIIRAM仓库索赔数据库中提取。在最初随机对照试验的泽伦组与对照组中,未发现疫苗接种率有差异。总体而言,在三年时间里,该队列中接种疫苗患者的比例从51.4%增至70.4%。前一年接种疫苗是次年接种疫苗的有力预测因素。疫苗接种率的提高,尤其是65岁以上人群接种率的提高,可以用队列效应来解释。健康促进和初级卫生保健的推广可能在这一增长中发挥了重要作用。

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本文引用的文献

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CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration.CONSORT 扩展报告用于使用队列和常规收集数据进行的随机对照试验 (CONSORT-ROUTINE):清单和解释。
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PLoS One. 2018 Feb 9;13(2):e0192155. doi: 10.1371/journal.pone.0192155. eCollection 2018.
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