METHODS: This is a mixed methods study of four phases to develop a core outcome set for refractory childhood epilepsy treated with ketogenic diet therapy. In phase 1, a systematic scoping review of the literature will establish which outcomes are measured in trials of refractory epilepsy treated with ketogenic diet therapy. In phase 2, qualitative interviews with parents and carers will aim to identify the outcomes of importance to these stakeholders. Phase 3 will see a comprehensive list of outcomes collated from the first two phases, grouped into domains according to an outcome taxonomy. Phase 4 will invite parents, health care professionals and researchers to participate in a two-round Delphi study to rate the importance of the presented outcomes. Following which, the core outcome set will be ratified at a face to face consensus meeting.
CONCLUSIONS: This study will guide outcome measurement in future studies of childhood epilepsy treated with ketogenic diet therapy and clinical practice through audit and service evaluation.
方法:这是一项四个阶段的混合方法研究,旨在开发经生酮饮食治疗的难治性儿童癫痫的核心结果集。在第1阶段,对文献进行系统的范围审查将确定在经生酮饮食治疗的难治性癫痫试验中测量哪些结果。在第2阶段,与父母和照顾者的定性访谈将旨在确定对这些利益相关者重要的结果。第三阶段将看到前两个阶段整理的全面成果清单,根据结果分类法分组到域中。第四阶段将邀请家长,卫生保健专业人员和研究人员参加两轮Delphi研究,以评估所提出的结果的重要性。之后,核心成果集将在面对面的共识会议上获得批准。
结论:本研究将通过审核和服务评估,指导未来用生酮饮食疗法治疗儿童癫痫的研究和临床实践的结果测量。