Ann Intern Med:电子推动增加流感疫苗接种的临床结果:一项全国性、实用、基于注册的随机实施试验的预先指定分析
本文由小咖机器人翻译整理
期刊来源:Ann Intern Med
原文链接:https://doi.org/10.7326/M23-2638
摘要内容如下:
背景
在Nudge-Flu(在全国范围内利用丹麦政府电子信件系统增加流感疫苗接种)试验中,包含心血管(CV)增益框架和重复信息的电子信件使流感疫苗接种增加了约1个百分点。
客观
评估成功的“轻推”干预对下游临床结果的影响。
设计
预先指定的全国随机实施试验的探索性分析。(ClinicalTrials.gov:NCT05542004)
设置
2022年至2023年流感季节。
参与者
964870名65岁或以上的丹麦公民。
干预
通常的护理或9种不同的电子传递的行为轻推信件。
测量
从介入治疗(2022年9月16日)至2023年5月31日随访期间的心血管、呼吸和其他临床终点。
结果
分析集包括691820名参与者。常规护理组的346327名参与者中有3354人(1.0%)因肺炎或流感住院,CV增益框架组的38586名参与者中有396人(1.0%)因肺炎或流感住院(风险比[HR],1.06[95%CI,0.95至1.18];与常规护理相比),重复字母组38231例中有403例(1.1%)(HR,1.09[CI,0.98至1.21];相对于常规护理)。在常规护理组中,有44682名(12.9%)参与者因任何原因住院,而在CV增益框架组中有5002名(13.0%)参与者因任何原因住院(HR,1.00[CI,0.97至1.03];与常规护理相比)和4965(13.0%)(HR,1.01[CI,0.98至1.04];相对于常规护理)。常规护理组共有6341名(1.8%)参与者死亡,而CV增益框架组有721名(1.9%)参与者死亡(HR,1.02[CI,0.94至1.10];与常规护理相比)和646(1.7%)在重复字母组(HR,0.92[CI,0.85至1.00];相对于常规护理)。
局限性
预先指定但探索性的分析,常规收集的登记数据中事件的潜在错误分类,以及结果可能无法推广到其他卫生系统或具有其他种族构成和/或文化或社会规范的国家。
结论
在一项预先指定的探索性分析中,通过电子轻推观察到的流感疫苗接种率的适度增加并没有转化为临床结果的显著改善。仍应强烈建议接种季节性流感疫苗。
主要资金来源
赛诺菲。
英文原文如下:
Abstracts
BACKGROUND In the NUDGE-FLU (Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake) trial, electronic letters incorporating cardiovascular (CV) gain-framing and repeated messaging increased influenza vaccination by approximately 1 percentage point.
OBJECTIVE To evaluate the effects of the successful nudging interventions on downstream clinical outcomes.
DESIGN Prespecified exploratory analysis of a nationwide randomized implementation trial. (ClinicalTrials.gov: NCT05542004).
SETTING The 2022 to 2023 influenza season.
PARTICIPANTS 964 870 Danish citizens aged 65 years or older.
INTERVENTION Usual care or 9 different electronically delivered behavioral nudging letters.
MEASUREMENTS Cardiovascular, respiratory, and other clinical end points during follow-up from intervention delivery (16 September 2022) through 31 May 2023.
RESULTS The analysis set included 691 820 participants. Hospitalization for pneumonia or influenza occurred in 3354 of 346 327 (1.0%) participants in the usual care group, 396 of 38 586 (1.0%) in the CV gain-framing group (hazard ratio [HR], 1.06 [95% CI, 0.95 to 1.18]; versus usual care), and 403 of 38 231 (1.1%) in the repeated letter group (HR, 1.09 [CI, 0.98 to 1.21]; versus usual care). In the usual care group, 44 682 (12.9%) participants were hospitalized for any cause, compared with 5002 (13.0%) in the CV gain-framing group (HR, 1.00 [CI, 0.97 to 1.03]; versus usual care) and 4965 (13.0%) in the repeated letter group (HR, 1.01 [CI, 0.98 to 1.04]; versus usual care). A total of 6341 (1.8%) participants died in the usual care group, compared with 721 (1.9%) in the CV gain-framing group (HR, 1.02 [CI, 0.94 to 1.10]; versus usual care) and 646 (1.7%) in the repeated letter group (HR, 0.92 [CI, 0.85 to 1.00]; versus usual care).
LIMITATION Prespecified but exploratory analysis, potential misclassification of events in routinely collected registry data, and results may not be generalizable to other health systems or countries with other racial compositions and/or cultural or societal norms.
CONCLUSION In a prespecified exploratory analysis, modest increases in influenza vaccination rates seen with electronic nudges did not translate into observable improvements in clinical outcomes. Seasonal influenza vaccination should remain strongly recommended.
PRIMARY FUNDING SOURCE Sanofi.
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