Faculty of Health, University of Plymouth, Plymouth, Devon, UK.
UCL Developmental Neurosciences, UCL - NIHR BRC Great Ormond Street Institute of Child Health, London, UK.
Trials. 2022 Aug 17;23(1):675. doi: 10.1186/s13063-022-06629-7.
A core outcome set defines the minimum outcomes that should be included in clinical trials, audit or practice. The aim being to increase the quality and relevance of research by ensuring consistency in the measurement and reporting of outcomes. Core outcome sets have been developed for a variety of disease states and treatments. However, there is no established set of core outcomes for refractory childhood epilepsy treated with ketogenic diet therapy. This should be developed using a patient-centred approach to ensure the outcomes measured are relevant to patients and clinical practice.
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.
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.
核心结局集定义了应包含在临床试验、审核或实践中的最小结局。其目的是通过确保对结局的测量和报告保持一致性，来提高研究的质量和相关性。已经为各种疾病状态和治疗方法制定了核心结局集。然而，对于接受生酮饮食治疗的难治性儿童癫痫，尚无既定的核心结局集。这应该使用以患者为中心的方法来制定，以确保测量的结局与患者和临床实践相关。
这是一项混合方法研究，共分为四个阶段，旨在为接受生酮饮食治疗的难治性儿童癫痫制定核心结局集。在第 1 阶段，将对文献进行系统的范围综述，以确定在使用生酮饮食治疗难治性癫痫的试验中测量的结局。在第 2 阶段，将对家长和照顾者进行定性访谈，旨在确定这些利益相关者关注的结局。第 3 阶段将从前两个阶段中整理出一份全面的结局清单，根据结局分类学将其归入各个领域。第 4 阶段将邀请家长、医疗保健专业人员和研究人员参与两轮 Delphi 研究，对所呈现的结局的重要性进行评分。之后，将在面对面的共识会议上批准核心结局集。
通过审核和服务评估，本研究将指导未来接受生酮饮食治疗的儿童癫痫的研究和临床实践中的结局测量。
