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In Reply: We appreciate the concern of Dr Kieling and colleagues regarding the small number of participants in ERSET. Our original plan was to make HRQOL the primary outcome measure, but we changed this to seizure freedom at the request of the National Institutes of Health review panel prior to approval for funding. Nevertheless, we believe our data support a benefit of surgery on HRQOL. Although the effect at 24 months did not reach statistical significance based on the primary intention-to-treat analysis (P=.08), significant differences were found at all earlier time points (P< .009) and at 24 months when postsurgery data from participants in the medical group who received surgery were excluded. The observed effects on secondary outcomes such as driving and socialization further justify a conclusion that early surgery results in psychosocial benefits relative to continued medical management.
机译:在答复中:我们感谢基林博士和同事对ERSET参与者人数少的关注。我们最初的计划是使HRQOL成为主要结局指标,但在批准资助之前,应美国国立卫生研究院审查小组的要求,我们将其更改为夺取自由。尽管如此,我们相信我们的数据支持HRQOL手术的益处。尽管根据主要的意向治疗分析,在24个月时的效果未达到统计学显着性(P = .08),但在所有较早的时间点(P <.009)和术后数据的24个月时均发现了显着差异。从接受手术的医学组参与者中排除。观察到的对诸如开车和社交等次要结果的影响进一步证明了以下结论:相对于持续的医疗管理,早期手术会带来社会心理效益。

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