Michaelis Rosa, Tang Venus, Nevitt Sarah J, Wagner Janelle L, Modi Avani C, LaFrance William Curt, Goldstein Laura H, Gandy Milena, Bresnahan Rebecca, Valente Kette, Donald Kirsten A, Reuber Markus
Department of Neurology Gemeinschaftskrankenhaus Herdecke, University of Witten/Herdecke, Herdecke, Germany.
Division of Neurosurgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Hospital Authority, Hong Kong.
Cochrane Database Syst Rev. 2020 Sep 7;8(8):CD012081. doi: 10.1002/14651858.CD012081.pub3.
Given the significant impact epilepsy may have on the health-related quality of life (HRQOL) of individuals with epilepsy and their families, there is increasing clinical interest in evidence-based psychological treatments, aimed at enhancing psychological and seizure-related outcomes for this group. This is an updated version of the original Cochrane Review published in Issue 10, 2017.
To assess the impact of psychological treatments for people with epilepsy on HRQOL outcomes.
For this update, we searched the following databases on 12 August 2019, without language restrictions: Cochrane Register of Studies (CRS Web), which includes randomized or quasi-randomized controlled trials from the Specialized Registers of Cochrane Review Groups including Epilepsy, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid, 1946 to 09 August 2019), and PsycINFO (EBSCOhost, 1887 onwards), and from PubMed, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (ICTRP). We screened the references from included studies and relevant reviews, and contacted researchers in the field for unpublished studies.
We considered randomized controlled trials (RCTs) and quasi-RCTs for this review. HRQOL was the main outcome. For the operational definition of 'psychological treatments', we included a broad range of skills-based psychological treatments and education-only interventions designed to improve HRQOL, seizure frequency and severity, as well as psychiatric and behavioral health comorbidities for adults and children with epilepsy. These psychological treatments were compared to treatment as usual (TAU), an active control group (such as social support group), or antidepressant pharmacotherapy.
We used standard methodological procedures expected by Cochrane.
We included 36 completed RCTs, with a total of 3526 participants. Of these studies, 27 investigated skills-based psychological interventions. The remaining nine studies were education-only interventions. Six studies investigated interventions for children and adolescents, three studies investigated interventions for adolescents and adults, and the remaining studies investigated interventions for adults. Based on satisfactory clinical and methodological homogeneity, we pooled data from 11 studies (643 participants) that used the Quality of Life in Epilepsy-31 (QOLIE-31) or other QOLIE inventories (such as QOLIE-89 or QOLIE-31-P) convertible to QOLIE-31. We found significant mean changes for the QOLIE-31 total score and six subscales (emotional well-being, energy and fatigue, overall QoL, seizure worry, medication effects, and cognitive functioning). The mean changes in the QOLIE-31 total score (mean improvement of 5.23 points, 95% CI 3.02 to 7.44; P < 0.001), and the overall QoL score (mean improvement of 5.95 points, 95% CI 3.05 to 8.85; P < 0.001) exceeded the threshold of minimally important change (MIC: total score: 4.73 points; QoL score: 5.22 points), indicating a clinically meaningful postintervention improvement in HRQOL. We downgraded the certainty of the evidence provided by the meta-analysis due to serious risks of bias in some of the included studies. Consequently, these results provided moderate-certainty evidence that psychological treatments for adults with epilepsy may enhance overall HRQOL.
AUTHORS' CONCLUSIONS: Implications for practice: Skills-based psychological interventions improve HRQOL in adults and adolescents with epilepsy. Adjunctive use of skills-based psychological treatments for adults and adolescents with epilepsy may provide additional benefits in HRQOL when these are incorporated into patient-centered management. We judge the evidence to be of moderate certainty.
Investigators should strictly adhere to the CONSORT guidelines to improve the quality of reporting on their interventions. A thorough description of intervention protocols is necessary to ensure reproducibility. When examining the effectiveness of psychological treatments for people with epilepsy, the use of standardized HRQOL inventories, such as the Quality of Life in Epilepsy Inventories (QOLIE-31, QOLIE-31-P, and QOLIE-89) would increase comparability. Unfortunately, there is a critical gap in pediatric RCTs and RCTs including people with epilepsy and intellectual disabilities. Finally, in order to increase the overall quality of RCT study designs, adequate randomization with allocation concealment and blinded outcome assessment should be pursued. As attrition is often high in research that requires active participation, an intention-to-treat analysis should be carried out. Treatment fidelity and treatment competence should also be assessed. These important dimensions, which are related to 'Risk of bias' assessment, should always be reported.
鉴于癫痫可能对癫痫患者及其家人的健康相关生活质量（HRQOL）产生重大影响，临床上越来越关注基于证据的心理治疗，旨在改善该群体的心理及与癫痫发作相关的结局。这是2017年第10期发表的原始Cochrane系统评价的更新版本。
评估针对癫痫患者的心理治疗对HRQOL结局的影响。
本次更新中，我们于2019年8月12日检索了以下数据库，无语言限制：Cochrane研究注册库（CRS网络版），其中包括来自Cochrane系统评价组专业注册库（包括癫痫）的随机或半随机对照试验、Cochrane对照试验中心注册库（CENTRAL）、MEDLINE（Ovid，1946年至2019年8月9日）、PsycINFO（EBSCOhost，1887年起），以及来自PubMed、Embase、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台（ICTRP）。我们筛选了纳入研究和相关综述的参考文献，并联系该领域的研究人员获取未发表的研究。
本综述纳入随机对照试验（RCT）和半随机对照试验。HRQOL是主要结局。对于“心理治疗”的操作定义，我们纳入了广泛的基于技能的心理治疗以及仅提供教育的干预措施，旨在改善癫痫成人和儿童的HRQOL、癫痫发作频率和严重程度，以及精神和行为健康合并症。这些心理治疗与常规治疗（TAU）、积极对照组（如社会支持组）或抗抑郁药物治疗进行比较。
我们采用Cochrane预期的标准方法程序。
我们纳入了36项完成的RCT，共3526名参与者。在这些研究中，27项研究调查了基于技能的心理干预。其余9项研究是仅提供教育的干预措施。6项研究调查了针对儿童和青少年的干预措施，3项研究调查了针对青少年和成人的干预措施，其余研究调查了针对成人的干预措施。基于满意的临床和方法学同质性，我们汇总了11项研究（643名参与者）的数据，这些研究使用了癫痫生活质量量表-31（QOLIE-31）或其他可转换为QOLIE-31的QOLIE量表（如QOLIE-89或QOLIE-31-P）。我们发现QOLIE-31总分及六个子量表（情绪幸福感、精力和疲劳、总体生活质量、癫痫发作担忧、药物影响和认知功能）有显著的平均变化。QOLIE-31总分的平均变化（平均改善5.23分，95%CI 3.02至7.44；P<0.001）和总体生活质量得分的平均变化（平均改善5.95分，95%CI 3.05至8.85；P<0.001）超过了最小重要变化阈值（MIC：总分：4.73分；生活质量得分：5.22分），表明干预后HRQOL有临床意义的改善。由于部分纳入研究存在严重的偏倚风险，我们降低了荟萃分析提供的证据的确定性。因此，这些结果提供了中等确定性的证据，表明针对癫痫成人的心理治疗可能会提高总体HRQOL。
对实践的启示：基于技能的心理干预可改善癫痫成人和青少年的HRQOL。将基于技能的心理治疗辅助用于癫痫成人和青少年，并将其纳入以患者为中心的管理中，可能会在HRQOL方面带来额外益处。我们认为证据具有中等确定性。
研究人员应严格遵循CONSORT指南，以提高其干预措施报告的质量。对干预方案进行全面描述对于确保可重复性是必要的。在研究癫痫患者心理治疗的有效性时，使用标准化的HRQOL量表，如癫痫生活质量量表（QOLIE-31、QOLIE-31-P和QOLIE-89）将提高可比性。遗憾的是，儿科RCT以及包括癫痫患者和智力残疾患者的RCT存在重大缺口。最后，为了提高RCT研究设计的整体质量，应采用充分的随机化、分配隐藏和盲法结局评估。由于在需要积极参与的研究中失访率往往较高，应进行意向性分析。还应评估治疗依从性和治疗能力。这些与“偏倚风险”评估相关的重要方面应始终予以报告。
