Abstract：
Ketogenic diet therapy (KDT) can result in benefits (seizure-related and non-seizure-related) for children with drug-resistant epilepsy. However, clinical trials report a wide range of outcomes, making synthesis of evidence difficult, and do not adequately reflect parent views on important outcomes for their child. To address this, we established the first international parent, health professional, and researcher consensus to develop a core outcome set, guided by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative (COMET registration #1116).
Ethical approval was granted (London-Surrey REC19/LO/1680). A scoping review and interviews with parents identified a comprehensive list of potentially important outcomes, followed by a two-round online Delphi survey of parents and health professionals to prioritize outcomes of importance for inclusion in a core outcome set. This informed a stakeholder consensus meeting and consultation process to finalize the core outcome set.
In total, 97 outcomes were identified; 90 from the scoping review and seven from parent interviews. These were rationalized to 77 by the study advisory group, then rated in the first Delphi round by 49 parents and 96 health professionals, who suggested 12 new outcomes for rating in Round 2. Sixty-six percent of participants (30 parents and 66 professionals) completed Round 2, where 22 outcomes met criteria for inclusion. In the consensus meeting (nine parents and 13 professionals), 27 undecided outcomes were discussed and scored; one further outcome reached consensus for inclusion. After consultation and ratification, 14 outcomes across five domains were included in the core outcome set.
A core outcome set for childhood epilepsy treated with KDT has been developed, incorporating the views of international parents and professionals. Implementation in research and clinical settings will standardize outcome selection and reporting, facilitate data synthesis, and ultimately enhance the relevance of outcomes to parents, researchers, and health professionals.
Ethical approval was granted (London-Surrey REC19/LO/1680). A scoping review and interviews with parents identified a comprehensive list of potentially important outcomes, followed by a two-round online Delphi survey of parents and health professionals to prioritize outcomes of importance for inclusion in a core outcome set. This informed a stakeholder consensus meeting and consultation process to finalize the core outcome set.
In total, 97 outcomes were identified; 90 from the scoping review and seven from parent interviews. These were rationalized to 77 by the study advisory group, then rated in the first Delphi round by 49 parents and 96 health professionals, who suggested 12 new outcomes for rating in Round 2. Sixty-six percent of participants (30 parents and 66 professionals) completed Round 2, where 22 outcomes met criteria for inclusion. In the consensus meeting (nine parents and 13 professionals), 27 undecided outcomes were discussed and scored; one further outcome reached consensus for inclusion. After consultation and ratification, 14 outcomes across five domains were included in the core outcome set.
A core outcome set for childhood epilepsy treated with KDT has been developed, incorporating the views of international parents and professionals. Implementation in research and clinical settings will standardize outcome selection and reporting, facilitate data synthesis, and ultimately enhance the relevance of outcomes to parents, researchers, and health professionals.
摘要：
目的：生酮饮食疗法（KDT）可以为耐药癫痫儿童带来益处（与癫痫发作无关）。然而,临床试验报告了广泛的结果，使综合证据变得困难，并且不能充分反映父母对孩子重要结果的看法。为了解决这个问题，我们成立了第一个国际母公司，卫生专业人员和研究人员达成共识，以制定核心结果集，在有效性试验(COMET)倡议(COMET注册#1116)的指导下。
方法：获得伦理批准（London-SurreyREC19/LO/1680）。范围审查和与父母的访谈确定了潜在重要结果的综合列表，随后是对父母和卫生专业人员进行的两轮在线Delphi调查，以优先考虑将重要结果纳入核心结果集。这为利益相关者共识会议和协商过程提供了信息，以最终确定核心成果集。
结果：总计，确定了97个结果；90个来自范围审查，7个来自家长访谈。研究咨询小组将这些合理化为77，然后在第一轮Delphi中由49名父母和96名卫生专业人员进行评级，他们在第二轮中提出了12个新的评级结果。66％的参与者（30名父母和66名专业人员）完成了第二轮比赛，其中22项结果符合纳入标准。在共识会议上(9名家长和13名专业人士)，对27项尚未决定的结果进行了讨论和评分；另一项结果达成了纳入共识。经过协商和批准，核心结果集中包括五个领域的14个结果。
结论：已经开发出了KDT治疗儿童癫痫的核心结果集，吸收国际家长和专业人士的意见。在研究和临床环境中的实施将标准化结果选择和报告，促进数据综合，并最终增强结果与父母的相关性，研究人员和卫生专业人员。
方法：获得伦理批准（London-SurreyREC19/LO/1680）。范围审查和与父母的访谈确定了潜在重要结果的综合列表，随后是对父母和卫生专业人员进行的两轮在线Delphi调查，以优先考虑将重要结果纳入核心结果集。这为利益相关者共识会议和协商过程提供了信息，以最终确定核心成果集。
结果：总计，确定了97个结果；90个来自范围审查，7个来自家长访谈。研究咨询小组将这些合理化为77，然后在第一轮Delphi中由49名父母和96名卫生专业人员进行评级，他们在第二轮中提出了12个新的评级结果。66％的参与者（30名父母和66名专业人员）完成了第二轮比赛，其中22项结果符合纳入标准。在共识会议上(9名家长和13名专业人士)，对27项尚未决定的结果进行了讨论和评分；另一项结果达成了纳入共识。经过协商和批准，核心结果集中包括五个领域的14个结果。
结论：已经开发出了KDT治疗儿童癫痫的核心结果集，吸收国际家长和专业人士的意见。在研究和临床环境中的实施将标准化结果选择和报告，促进数据综合，并最终增强结果与父母的相关性，研究人员和卫生专业人员。
