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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:在回复中:我们感谢Kieling博士和同事们对少数人参与者的关切。 我们的原始计划是使HRQOL是主要的结果措施,但我们在批准资金之前将此改变为扣押自由,以便在国家卫生审查小组的要求下扣押自由。 尽管如此,我们认为我们的数据支持在HRQOL上进行手术的好处。 虽然24个月的效果没有基于主要的意图分析(p = .08)达到统计学意义(p = .08),但在所有早期的时间点(p <.009)和后24个月时发现了显着的差异 来自接受手术的医疗组的参与者被排除在外。 观察到的二次结果效果,如驾驶和社会化进一步证明了一个结论,即早期手术导致相对于持续的医疗管理的心理社会效益。

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