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针对成年癫痫患者的服务提供、行为及自我管理干预措施。

Service delivery, behavioural, and self-management interventions for adults with epilepsy.

作者信息

Huang Yun, Nevitt Sarah J, Mayer Josephine, Fleeman Nigel, Hill Ruaraidh A, Doherty Alison J, Wilson Neil, Boland Paul, Clegg Andrew J, Bilsborough Helena, Williams Elsie J, Maden Michelle, Shaw Elizabeth J, Tudur Smith Catrin, Kelly Rachael, Marson Anthony G

机构信息

Clinical Infection, Microbiology and Immunology, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.

The Walton Centre NHS Foundation Trust, Liverpool, UK.

出版信息

Cochrane Database Syst Rev. 2025 Sep 24;9(9):CD015284. doi: 10.1002/14651858.CD015284.pub2.

Abstract

BACKGROUND

Epilepsy is a common condition, affecting around 660 per 100,000 people worldwide. Despite treatment with anti-seizure medications, one-third of people do not achieve seizure control. There is a need to focus on models of service delivery and therapies that target cognitive, psychological, and behavioural aspects to improve seizure control and quality of life.

OBJECTIVES

To assess the effects of service delivery, behavioural, and self-management inventions on seizure control and health-related quality of life in adults with epilepsy.

SEARCH METHODS

We used the Cochrane Register of Studies, MEDLINE, and two other databases, together with reference checking and contact with study authors, to identify the studies included in the review. The latest search date was 21 August 2023.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) or quasi-RCTs of any design (double/single-blinded, unblinded; parallel, cross-over, or cluster) involving participants with a mean age of 16 or older. Eligible interventions included behavioural, self-management, or service-delivery approaches. Behavioural and self-management interventions had to report seizure control as an outcome.

DATA COLLECTION AND ANALYSIS

Our primary outcome was seizure frequency. Our secondary outcomes were: seizure severity, health-related quality of life (HRQoL), medication usage, knowledge, general health, social and psychological function, and adverse events. We classified outcomes as short-term (up to six months) or long-term (over six months). At least two review authors independently screened all papers, extracted data, assessed the risk of bias, and analysed data. We used GRADE to assess the certainty of the evidence.

MAIN RESULTS

We included 36 studies with 5834 randomised participants. Twenty-six studies included participants with a diagnosis of epilepsy, six studies included participants with severe or drug-resistant epilepsy, and four studies included participants with epilepsy and another comorbidity, including depression, psychosocial problems, or learning disabilities. We rated 16 studies as having an overall low risk of bias, 11 studies as high risk, and nine studies with an unclear risk of bias. Twenty-one studies were conducted in high-income countries, seven in upper-middle-income countries, and eight in lower-middle-income countries. We categorised interventions into psycho-behavioural, mind-body, self-management, physical exercise, nurse-led service delivery, and other service delivery interventions. Seizure frequency Two studies showed that psycho-behavioural interventions likely reduce seizure frequency at three to six months (mean seizure frequency reduction 4.42 per month, 95% confidence interval (CI) 6.41 per month lower to 2.43 per month lower; 64 participants; moderate-certainty evidence). However, this intervention may not improve seizure frequency immediately post-intervention. Three studies showed that mind-body interventions may reduce seizure frequency slightly at six to eight weeks (mean seizure frequency reduction 3.28 per month, 95% CI 6.36 per month lower to 0.20 per month lower; 148 participants; low-certainty evidence). However, evidence from two studies suggests that such interventions have no effect on seizure control. Evidence from three studies suggests that self-management interventions may not reduce seizure frequency between 20 weeks and six months (mean seizure frequency was 1.61 per month higher, 95% CI 6.08 per month lower to 9.29 per month higher; 222 participants; low-certainty evidence). However, three studies showed these interventions are likely to increase seizure freedom. In the short term, the effect of physical exercise on seizure control is very uncertain. Evidence from one study suggests that a nurse-led service delivery intervention does not improve seizure frequency. No data were available for other service-based interventions. The long-term data (> six months) for psycho-behavioural, self-management, and service-based interventions are limited. There are no long-term data available for mind-body, physical exercise, or nurse-led service delivery interventions. Health-related quality of life One study reported that psycho-behavioural interventions likely result in no difference in Quality of Life in Epilepsy Inventory (QOLIE)-10 total score at six months (mean total score was 0.89 higher, 95% CI 1.06 lower to 2.84 higher; 120 participants; moderate-certainty evidence). Overall, there is very uncertain evidence of the short- and long-term effect of psycho-behavioural interventions on HRQoL outcomes. One study showed that mind-body interventions may result in no difference in QOLIE-31-P (31-item questionnaire with patient-weighted scoring system) total scores at six weeks (mean total score was 0.75 higher, 95% CI 5.49 lower to 6.99 higher; 60 participants; low-certainty evidence). Two studies showed that self-management interventions probably do not improve the mean QOLIE-31 or QOLIE-31-P total scores at six months (mean scores 2.42 higher, 95% CI 2.58 lower to 7.42 higher; 393 participants; moderate-certainty evidence). However, one study showed that these interventions are likely to result in a slight improvement in QOLIE-10 total scores. Four studies showed that this intervention probably does not improve HRQoL outcomes. We are very uncertain about the effect of this intervention on long-term outcomes. Three studies showed that physical exercise may result in no difference to HRQoL outcomes in the short term. Two studies showed that nurse-led service delivery interventions probably do not improve outcomes in the short or long term. One study showed that a service delivery-based intervention likely results in an improvement in HRQoL in the long term. Other outcomes Evidence for improvements in epilepsy knowledge, medication usage, general health, social and psychological function was very limited and showed no consistent differences between interventions and controls. There were no reported adverse events related to the interventions.

AUTHORS' CONCLUSIONS: There is no high-certainty evidence that service delivery, behavioural, and self-management interventions improve seizure control or quality of life outcomes for adults with epilepsy. There were wide variations in the size of the effect estimate, depending on how outcomes were measured. Furthermore, there was significant clinical heterogeneity amongst the populations studied, types of interventions delivered, study setting, and study design, which limit interpretation of the currently available evidence and its overall applicability. Further research is needed from well-designed studies using validated measures to assess long-term improvement in outcomes important to adults with epilepsy.

摘要

背景

癫痫是一种常见疾病,全球每10万人中约有660人受其影响。尽管使用抗癫痫药物进行治疗,但仍有三分之一的人无法实现癫痫发作控制。有必要关注针对认知、心理和行为方面的服务提供模式和治疗方法,以改善癫痫发作控制和生活质量。

目的

评估服务提供、行为和自我管理干预措施对成年癫痫患者癫痫发作控制及健康相关生活质量的影响。

检索方法

我们使用了Cochrane研究注册库、MEDLINE以及其他两个数据库,并通过参考文献核对和与研究作者联系,以识别纳入综述的研究。最新检索日期为2023年8月21日。

选择标准

我们纳入了任何设计的随机对照试验(RCT)或准RCT(双盲/单盲、非盲;平行、交叉或整群),参与者平均年龄为16岁或以上。符合条件的干预措施包括行为、自我管理或服务提供方法。行为和自我管理干预措施必须将癫痫发作控制作为一项结果进行报告。

数据收集与分析

我们的主要结果是癫痫发作频率。次要结果包括:癫痫发作严重程度、健康相关生活质量(HRQoL)、药物使用、知识、总体健康、社会和心理功能以及不良事件。我们将结果分为短期(长达六个月)或长期(超过六个月)。至少两名综述作者独立筛选所有论文、提取数据、评估偏倚风险并分析数据。我们使用GRADE评估证据的确定性。

主要结果

我们纳入了36项研究,共5834名随机参与者。26项研究的参与者被诊断患有癫痫,6项研究的参与者患有严重或耐药性癫痫,4项研究的参与者患有癫痫并伴有其他合并症,包括抑郁症、心理社会问题或学习障碍。我们将16项研究评为总体偏倚风险低,11项研究为高风险,9项研究的偏倚风险不明确。21项研究在高收入国家进行,7项在中高收入国家进行,8项在中低收入国家进行。我们将干预措施分为心理行为、身心、自我管理、体育锻炼、护士主导的服务提供以及其他服务提供干预措施。癫痫发作频率:两项研究表明,心理行为干预措施可能在三至六个月时降低癫痫发作频率(平均每月癫痫发作频率降低4.42次,95%置信区间(CI)为每月降低6.41次至每月降低2.43次;64名参与者;中等确定性证据)。然而,这种干预措施在干预后即刻可能不会改善癫痫发作频率。三项研究表明,身心干预措施可能在六至八周时略微降低癫痫发作频率(平均每月癫痫发作频率降低3.28次,95%CI为每月降低6.36次至每月降低0.20次;148名参与者;低确定性证据)。然而,两项研究的证据表明此类干预措施对癫痫发作控制没有效果。三项研究的证据表明,自我管理干预措施在20周和六个月之间可能不会降低癫痫发作频率(平均每月癫痫发作频率高1.61次,95%CI为每月降低6.08次至每月高9.29次;222名参与者;低确定性证据)。然而,三项研究表明这些干预措施可能会增加无癫痫发作率。短期内,体育锻炼对癫痫发作控制的影响非常不确定。一项研究的证据表明,护士主导的服务提供干预措施不会改善癫痫发作频率。其他基于服务的干预措施没有可用数据。心理行为、自我管理和基于服务的干预措施的长期数据(>六个月)有限。身心、体育锻炼或护士主导的服务提供干预措施没有长期数据。健康相关生活质量:一项研究报告称,心理行为干预措施可能在六个月时对癫痫生活质量量表(QOLIE)-10总分没有差异(平均总分高0.89分,95%CI为低1.06分至高2.84分;120名参与者;中等确定性证据)。总体而言,心理行为干预措施对HRQoL结果的短期和长期影响证据非常不确定。一项研究表明,身心干预措施可能在六周时对QOLIE-31-P(31项问卷,采用患者加权评分系统)总分没有差异(平均总分高0.75分,95%CI为低5.49分至高6.99分;60名参与者;低确定性证据)。两项研究表明,自我管理干预措施可能在六个月时不会改善平均QOLIE-31或QOLIE-31-P总分(平均得分高2.42分,95%CI为低2.58分至高7.42分;393名参与者;中等确定性证据)。然而,一项研究表明这些干预措施可能会使QOLIE-10总分略有改善。四项研究表明,这种干预措施可能不会改善HRQoL结果。我们对这种干预措施对长期结果的影响非常不确定。三项研究表明,体育锻炼在短期内可能对HRQoL结果没有差异。两项研究表明,护士主导的服务提供干预措施在短期或长期内可能不会改善结果。一项研究表明,基于服务提供的干预措施可能会在长期内改善HRQoL。其他结果:关于癫痫知识、药物使用、总体健康、社会和心理功能改善的证据非常有限,且干预措施与对照组之间没有一致的差异。没有报告与干预措施相关的不良事件。

作者结论

没有高确定性证据表明服务提供、行为和自我管理干预措施能改善成年癫痫患者的癫痫发作控制或生活质量结果。根据结果测量方式的不同,效应估计值的大小存在很大差异。此外,在所研究的人群、实施的干预措施类型、研究环境和研究设计方面存在显著的临床异质性,这限制了对现有证据的解释及其总体适用性。需要进行精心设计的研究,使用经过验证的测量方法来评估对成年癫痫患者重要的结果的长期改善情况。

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