Mee Harry, Castaño-Leon Ana M, Timofeev Ivan, Adeleye Amos, Devi Bhagavatula Indira, Marklund Niklas, Muehlschlegel Susanne, Bond Katie, Clement Clare, Grieve Kirsty, Owen Nicola, Whiting Gemma, Turner Carole, Rubiano Escobar Andres Mariano, Shukla Dhaval, Paul Maria, Allanson Judith, Pomeroy Valerie, Viaroli Edoardo, Warburton Elizabeth, Wells Adam, Hawryluk Gregory, Helmy Adel, Anwar Fahim, Honeybul Stephen, Hutchinson Peter, Kolias Angelos
Division of Rehabilitation Medicine and Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.
Division of Rehabilitation Medicine, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.
JMIR Res Protoc. 2023 Apr 17;12:e37442. doi: 10.2196/37442.
Core outcome sets (COSs) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury (TBI) or stroke is becoming increasingly common, leading to an ever-growing clinical and research interest, especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to limited meta-analysis ability and an ongoing risk of outcome reporting bias. This study aims to define a standardized COS for reporting in all future TBI and stroke cranioplasty studies.
This study has four aims: (1) undertake a systematic review to collate the most current outcome measures used within the cranioplasty literature; (2) undertake a qualitative study to understand better the views of clinicians, patients' relatives, and allied health professionals regarding clinical outcomes following cranioplasty; (3) undertake a Delphi survey as part of the process of gaining consensus for the COS; and (4) finalize consensus through a consensus meeting resulting in the COS.
An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. Phase 1 is data collection through a systematic review and qualitative study. Phase 2 is the COS development through a Delphi survey and consensus meetings with consensus definitions decided and agreed upon before the Delphi survey begins to avoid bias.
Phase 1 started at the end of 2019, following ethical approval in December 2019, and the project completion date is planned for the end of 2022 or beginning of 2023.
This study should result in a consensus on a COS for cranioplasty, following TBI or stroke, to help standardize outcome reporting for future studies, which can be applied to future research and clinical services, help align future studies, build an increased understanding of cranioplasty and its impact on a patient's function and recovery, and help standardize the evidence base.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37442.
核心结局集（COSs）很重要且必要，因为它们有助于规范研究报告。创伤性脑损伤（TBI）或中风后的颅骨修补术越来越普遍，引发了越来越多的临床和研究兴趣，特别是关于颅骨修补术的最佳材料、成本效益以及与神经功能恢复和并发症相关的手术时机。因此，这些不同研究结果的异质性报告导致荟萃分析能力有限，且存在结果报告偏倚的持续风险。本研究旨在定义一个标准化的核心结局集，用于未来所有TBI和中风颅骨修补术研究的报告。
本研究有四个目标：（1）进行系统评价，以整理颅骨修补术文献中使用的最新结局指标；（2）进行定性研究，以更好地了解临床医生、患者亲属和专职医疗人员对颅骨修补术后临床结局的看法；（3）作为核心结局集达成共识过程的一部分，进行德尔菲调查；（4）通过共识会议最终确定共识，形成核心结局集。
已成立一个国际指导委员会来指导核心结局集的制定。此外，还遵循了其他临床倡议（如COMET（核心结局与有效性试验）和OMERACT（风湿病学结局指标））的建议。第1阶段是通过系统评价和定性研究收集数据。第2阶段是通过德尔菲调查和共识会议来制定核心结局集，在德尔菲调查开始前确定并商定共识定义以避免偏倚。
第1阶段于2019年底开始，2019年12月获得伦理批准，项目计划于2022年底或2023年初完成。
本研究应就TBI或中风后颅骨修补术的核心结局集达成共识，以帮助规范未来研究的结局报告，可应用于未来的研究和临床服务，有助于统一未来研究，增进对颅骨修补术及其对患者功能和恢复影响的理解，并有助于规范证据基础。
国际注册报告识别码（IRRID）：DERR1-10.2196/37442
