Department of Neurosurgery, Maastricht University Medical Centre+, Maastricht, The Netherlands
Department of Neurosurgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.
BMJ Open. 2023 Jul 5;13(7):e064263. doi: 10.1136/bmjopen-2022-064263.
Resective epilepsy surgery is often seen as a last resort when treating drug-resistant epilepsy. Positive results on quality of life (QoL) and economic benefits after surgery argue for a less restrictive attitude towards epilepsy surgery for drug-resistant epilepsy. QoL and economic benefits are country-dependent. The objective of the Resective Epilepsy Surgery, QUality of life and Economic evaluation (RESQUE) trial is to evaluate the change in QoL before and after epilepsy surgery in Dutch people with drug-resistant epilepsy. The results will form part of an economic evaluation of epilepsy surgery in people with epilepsy (PWE) in The Netherlands.
A longitudinal prospective multicentre cohort study involving 100 PWE undergoing epilepsy surgery between 2019 and 2025 is being performed in three Dutch academic hospitals. Excluded are PWE who have a lower level of intelligence (TIQ<70) or who do not master the Dutch language. Before surgery and 3, 6, 12 and 24 months after surgery, PWE receive validated online questionnaires (QOLIE-31, EQ-5D, iMCQ and iPCQ) on QoL, cost of care, expectations and satisfaction. Primary outcome is the change in QoL. Secondary outcomes are change in generic QoL, seizure reduction (International League Against Epilepsy Outcome Classification), medical consumption, productivity, the correlation between QoL and seizure reduction and expectation of and satisfaction with the surgery.
The study design has been approved by the Medical Ethics Review Committee (METC) of Maastricht UMC+ (2019-1134) and the Amsterdam UMC (vu). At the time of writing, UMC Utrecht is in the process of considering approval. The study will be conducted according to the Dutch Medical Research Involving Human Subjects Act and the Declaration of Helsinki. The results will be publicly disclosed and submitted for publication in international peer-reviewed scientific journals. There is no veto on publication by the involved parties.
NL8278; Pre-results.
对于耐药性癫痫的治疗，切除性癫痫手术通常被视为最后的手段。手术后生活质量（QoL）和经济效益的积极结果表明，对于耐药性癫痫患者，手术治疗应该采取不那么严格的态度。生活质量和经济效益因国家而异。Resective Epilepsy Surgery，QUality of life and Economic evaluation（RESQUE）试验的目的是评估荷兰耐药性癫痫患者在接受癫痫手术后 QoL 的变化。该结果将构成对荷兰癫痫患者（PWE）癫痫手术的经济评估的一部分。
正在荷兰的三家学术医院对 100 名接受癫痫手术的 PWE 进行一项前瞻性纵向多中心队列研究。排除智力水平较低（TIQ<70）或不精通荷兰语的 PWE。在手术前以及手术后 3、6、12 和 24 个月，PWE 将接受在线问卷（QOLIE-31、EQ-5D、iMCQ 和 iPCQ），以评估 QoL、护理成本、预期和满意度。主要结局是 QoL 的变化。次要结局包括一般 QoL 的变化、癫痫发作减少（国际抗癫痫联盟结局分类）、医疗消耗、生产力、QoL 与癫痫发作减少的相关性以及对手术的期望和满意度。
该研究设计已获得 Maastricht UMC+（2019-1134）和阿姆斯特丹 UMC（VU）的医学伦理审查委员会（METC）的批准。在撰写本文时，乌得勒支 UMC 正在考虑批准。该研究将按照荷兰涉及人体的医学研究法和赫尔辛基宣言进行。研究结果将公开披露，并提交国际同行评议的科学期刊发表。各参与方对发表没有否决权。
NL8278；预结果。
