中风准备活动对院前延误的影响：一项阶梯式楔形整群随机对照试验（SW-RCT）
Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial).
作者信息
Denti Licia, Caminiti Caterina, Scoditti Umberto, Zini Andrea, Malferrari Giovanni, Zedde Maria Luisa, Guidetti Donata, Baratti Mario, Vaghi Luca, Montanari Enrico, Marcomini Barbara, Riva Silvia, Iezzi Elisa, Castellini Paola, Olivato Silvia, Barbi Filippo, Perticaroli Eva, Monaco Daniela, Iafelice Ilaria, Bigliardi Guido, Vandelli Laura, Guareschi Angelica, Artoni Andrea, Zanferrari Carla, Schulz Peter J
机构信息
From the Geriatrics Ward-Stroke Care Section, (L.D., A.A.), Research and Innovation Unit (C.C., B.M., E.I.), and Stroke Care Program (U.S., P.C., C.Z.), University Hospital of Parma, Italy; Stroke Unit, Nuovo Ospedale Civile S Agostino Estense, University Hospital of Modena, Italy (A.Z., M.B., L. Vaghi, S.O., F.B., G.B., L. Vandelli); Stroke Unit, Neurology Unit, Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia, Italy (G.M., M.L.Z., E.P., D.M.); Department of Neurology, Guglielmo da Saliceto Hospital, Piacenza, Italy (D.G., I.I.); Neurology Unit, Vaio Fidenza Hospital, Italy (E.M., A.G.); Department of Oncology and Hemato-oncology, University of Milan, Italy (S.R.); and Institute of Communication and Health, University of Svizzera Italiana, Lugano, Switzerland (P.J.S.).
出版信息
Stroke. 2017 Dec;48(12):3316-3322. doi: 10.1161/STROKEAHA.117.018135. Epub 2017 Nov 3.
BACKGROUND AND PURPOSE
Public campaigns to increase stroke preparedness have been tested in different contexts, showing contradictory results. We evaluated the effectiveness of a stroke campaign, designed specifically for the Italian population in reducing prehospital delay.
METHODS
According to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial) design, the campaign was launched in 4 provinces in the northern part of the region Emilia Romagna at 3-month intervals in randomized sequence. The units of analysis were the patients admitted to hospital, with stroke and transient ischemic attack, over a time period of 15 months, beginning 3 months before the intervention was launched in the first province to allow for baseline data collection. The proportion of early arrivals (within 2 hours of symptom onset) was the primary outcome. Thrombolysis rate and some behavioral end points were the secondary outcomes. Data were analyzed using a fixed-effect model, adjusting for cluster and time trends.
RESULTS
We enrolled 1622 patients, 912 exposed and 710 nonexposed to the campaign. The proportion of early access was nonsignificantly lower in exposed patients (354 [38.8%] versus 315 [44.4%]; adjusted odds ratio, 0.81; 95% confidence interval, 0.60-1.08; =0.15). As for secondary end points, an increase was found for stroke recognition, which approximated but did not reach statistical significance (=0.07).
CONCLUSIONS
Our campaign was not effective in reducing prehospital delay. Even if some limitations of the intervention, mainly in terms of duration, are taken into account, our study demonstrates that new communication strategies should be tested before large-scale implementation.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01881152.
背景与目的
旨在提高中风应急准备能力的公共宣传活动已在不同环境中进行了测试，结果相互矛盾。我们评估了一项专门为意大利人群设计的中风宣传活动在减少院前延误方面的有效性。
方法
根据阶梯楔形整群随机对照试验（SW-RCT）设计，该宣传活动于3个月的间隔内在艾米利亚-罗马涅大区北部的4个省份以随机顺序启动。分析单位是在干预在第一个省份启动前3个月开始的15个月时间内入院的中风和短暂性脑缺血发作患者，以便收集基线数据。早期到达（症状发作后2小时内）的比例是主要结局。溶栓率和一些行为终点是次要结局。使用固定效应模型分析数据，并对整群和时间趋势进行调整。
结果
我们纳入了1622例患者，其中912例接触了该宣传活动，710例未接触。接触宣传活动的患者中早期就诊的比例略低，但无统计学意义（354例[38.8%]对315例[44.4%]；调整后的优势比为0.81；95%置信区间为0.60-1.08；P=0.15）。至于次要终点，中风识别率有所提高，接近但未达到统计学意义（P=0.07）。
结论
我们的宣传活动在减少院前延误方面无效。即使考虑到干预措施的一些局限性，主要是在持续时间方面，我们的研究表明，在大规模实施之前应测试新的沟通策略。
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