Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Department of Physical Therapy, College of Applied Medical Science, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Dev Med Child Neurol. 2023 Feb;65(2):254-263. doi: 10.1111/dmcn.15351. Epub 2022 Jul 22.
To develop a core set of outcome domains to be measured in clinical studies on lower limb orthopaedic surgery for ambulant children with cerebral palsy (CP) that represents the priorities of an international multi-stakeholder group (children, parent/carers, and health professionals).
Potential outcome domains were identified through literature review and qualitative interviews with key stakeholders. These were scored in an international two-round Delphi survey, using a 9-point Likert scale. A final consensus meeting with key stakeholders agreed on the most important outcome domains and refined the core outcome set (COS).
One hundred and sixty-one health professionals and 36 individuals with CP and their parents/carers rated 21 of 41 outcomes as important in the Delphi survey. The final consensus group agreed 19 outcomes within eight domains to be included in the final COS: pain and fatigue, lower limb structure, motor function, mobility (daily life activities), gait-related outcomes, physical activity, independence, and quality of life.
A COS for lower limb orthopaedic surgery for children with CP was developed. Incorporating this in the design of future clinical studies will provide a more holistic assessment of the impact of treatment while allowing meaningful comparisons and future synthesis of results from primary studies.
Eight core outcome domains were identified as important to measure in future clinical research. Key stakeholders perceived pain, balance and fall, and independence as very important outcomes. Six contextual factors were identified as essential in surgical decision-making.
为有步行能力的脑瘫儿童下肢矫形外科的临床研究开发一套核心结局测量指标，这些指标能反映国际多利益相关者群体（儿童、家长/照顾者和卫生专业人员）的重点。
通过文献回顾和对主要利益相关者的定性访谈，确定潜在的结局领域。这些领域在国际两轮德尔菲调查中使用 9 分李克特量表进行评分。最后，由主要利益相关者参加的共识会议商定了最重要的结局领域，并对核心结局集（COS）进行了精炼。
在德尔菲调查中，161 名卫生专业人员和 36 名脑瘫患者及其家长/照顾者对 41 个结局中的 21 个进行了重要性评分。最终的共识小组同意将八个领域内的 19 个结局纳入最终的 COS：疼痛和疲劳、下肢结构、运动功能、移动性（日常生活活动）、步态相关结局、体力活动、独立性和生活质量。
为脑瘫儿童下肢矫形外科制定了一个 COS。在未来的临床研究设计中纳入这一指标将提供更全面的治疗效果评估，同时允许对主要研究结果进行有意义的比较和未来综合分析。
确定了未来临床研究中需要测量的 8 个核心结局领域。主要利益相关者认为疼痛、平衡和跌倒以及独立性是非常重要的结局。确定了 6 个手术决策中必不可少的情境因素。
