Evaluation of Kilifi epilepsy education programme: a randomized controlled trial.

Evaluation of Kilifi epilepsy education programme: a randomized controlled trial.
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DOI:
10.1111/epi.12498
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发表时间:
2014-02
期刊:
影响因子:
5.6
通讯作者:
Newton CR
Newton CR
中科院分区:
医学1区
文献类型:
--
作者:
Ibinda F;Mbuba CK;Kariuki SM;Chengo E;Ngugi AK;Odhiambo R;Lowe B;Fegan G;Carter JA;Newton CR

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在资源贫乏的国家,癫痫治疗缺口最大。我们评估了肯尼亚农村地区为期一天的健康教育项目的效果。主要结果是通过血液中的药物水平来衡量抗癫痫药物(AED)的依从性,次要结果是癫痫发作频率和Kilifi癫痫信念和态度评分(KEBAS)。738名癫痫患者和他们指定的支持者被随机分为干预组(教育)和非干预组。干预组在教育干预前和干预后1年收集数据。在两个时间点都有581名患者接受了PWE评估。在研究结束时,来自干预组的105名PWE和来自非干预组的86名PWE提供了血液样本,并对最常用的抗癫痫药物(苯巴比妥、苯妥英和卡马西平)进行了检测。使用标准的血液分析方法确定可检测到AED水平的PWE的比例。进行化验的实验室技术人员对随机化视而不见。通过由训练有素的外地工作人员发放的问卷对次要结果进行评估。采用改进的Poisson回归方法研究与改善依从性(从基线时血液中非最佳AED水平转变到随访时最佳水平)、减少癫痫发作和改善KEBAS的相关因素,这是一项事后分析。该试验在ISRCTN注册表中注册,编号为ISRCTN35680481。根据可检测的药物水平(优势比[OR]1.46,95%可信区间[95%CI]0.74-2.90,p=0.28)或自我报告(OR 1.00,95%CI 0.71-1.40,p=1.00),干预组和非干预组对AEDs的依从性没有显著差异。与非干预组相比,干预组对癫痫的传统病因、文化治疗和负面刻板印象的信念明显减少。两组癫痫发作频率无差异。基线和随访数据的比较显示,使用可检测的血液水平,坚持干预组(36-81%[p<0.001])和非干预组(38-74%[p<0.001])显著增加。较少发作(最近3个月≤3发作)的患者在干预组(62-80%,p=0.002)和非干预组(67-75%,p=0.04)中增加。改善的治疗依从性(在两组中都观察到)与癫痫风险信念的积极变化(相对风险[RR]2.00,95%可信区间1.03~3.95)和具有非传统宗教信仰(相对危险度2.01,95%可信区间1.01~3.99)呈正相关。癫痫发作频率的减少与依从性的改善相关(RR 1.72,95%CI 1.19~2.47)。与没有接受过高等教育相比,KEBAS的积极变化与接受过高等教育有关(RR 1.09,95%CI 1.05-1.14)。健康教育提高了对癫痫的认识,但只接触一次并不能提高依从性。然而,持续的教育可能会提高未来研究的坚持性。
The epilepsy treatment gap is largest in resource-poor countries. We evaluated the efficacy of a 1-day health education program in a rural area of Kenya. The primary outcome was adherence to antiepileptic drugs (AEDs) as measured by drug levels in the blood, and the secondary outcomes were seizure frequency and Kilifi Epilepsy Beliefs and Attitudes Scores (KEBAS). Seven hundred thirty-eight people with epilepsy (PWE) and their designated supporter were randomized to either the intervention (education) or nonintervention group. Data were collected at baseline and 1 year after the education intervention was administered to the intervention group. There were 581 PWE assessed at both time points. At the end of the study, 105 PWE from the intervention group and 86 from the nonintervention group gave blood samples, which were assayed for the most commonly used AEDs (phenobarbital, phenytoin, and carbamazepine). The proportions of PWE with detectable AED levels were determined using a standard blood assay method. The laboratory technicians conducting the assays were blinded to the randomization. Secondary outcomes were evaluated using questionnaires administered by trained field staff. Modified Poisson regression was used to investigate the factors associated with improved adherence (transition from nonoptimal AED level in blood at baseline to optimal levels at follow-up), reduced seizures, and improved KEBAS, which was done as a post hoc analysis. This trial is registered in ISRCTN register under ISRCTN35680481. There was no significant difference in adherence to AEDs based on detectable drug levels (odds ratio [OR] 1.46, 95% confidence interval [95% CI] 0.74–2.90, p = 0.28) or by self-reports (OR 1.00, 95% CI 0.71–1.40, p = 1.00) between the intervention and nonintervention group. The intervention group had significantly fewer beliefs about traditional causes of epilepsy, cultural treatment, and negative stereotypes than the nonintervention group. There was no difference in seizure frequency. A comparison of the baseline and follow-up data showed a significant increase in adherence—intervention group (36–81% [p < 0.001]) and nonintervention group (38–74% [p < 0.001])—using detectable blood levels. The number of patients with less frequent seizures (≤3 seizures in the last 3 months) increased in the intervention group (62–80% [p = 0.002]) and in the nonintervention group (67–75% [p = 0.04]). Improved therapeutic adherence (observed in both groups combined) was positively associated with positive change in beliefs about risks of epilepsy (relative risk [RR] 2.00, 95% CI 1.03–3.95) and having nontraditional religious beliefs (RR 2.01, 95% CI 1.01–3.99). Reduced seizure frequency was associated with improved adherence (RR 1.72, 95% CI 1.19–2.47). Positive changes in KEBAS were associated with having tertiary education as compared to none (RR 1.09, 95% CI 1.05–1.14). Health education improves knowledge about epilepsy, but once only contact does not improve adherence. However, sustained education may improve adherence in future studies.
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发表时间: 2005-03-22
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