Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK
Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
BMJ Open. 2022 May 9;12(5):e057384. doi: 10.1136/bmjopen-2021-057384.
Meningioma is the most common primary intracranial tumour in adults. The majority are non-malignant, but a proportion behave more aggressively. Incidental/minimally symptomatic meningioma are often managed by serial imaging. Symptomatic meningioma, those that threaten neurovascular structures, or demonstrate radiological growth, are usually resected as first-line management strategy. For patients in poor clinical condition, or with inoperable, residual or recurrent disease, radiotherapy is often used as primary or adjuvant treatment. Effective pharmacotherapy treatments do not currently exist. There is heterogeneity in the outcomes measured and reported in meningioma clinical studies. Two 'Core Outcome Sets' (COS) will be developed: (COSMIC: Intervention) for use in meningioma clinical effectiveness trials and (COSMIC: Observation) for use in clinical studies of incidental/untreated meningioma.
Two systematic literature reviews and trial registry searches will identify outcomes measured and reported in published and ongoing (1) meningioma clinical effectiveness trials, and (2) clinical studies of incidental/untreated meningioma. Outcomes include those that are clinician reported, patient reported, caregiver reported and based on objective tests (eg, neurocognitive tests), as well as measures of progression and survival. Outcomes will be deduplicated and categorised to generate two long lists. The two long lists will be prioritised through two, two-round, international, modified eDelphi surveys including patients with meningioma, healthcare professionals, researchers and those in caring/supporting roles. The two final COS will be ratified through two 1-day online consensus meetings, with representation from all stakeholder groups.
Institutional review board (University of Liverpool) approval was obtained for the conduct of this study. Participant eConsent will be obtained prior to participation in the eDelphi surveys and consensus meetings. The two systematic literature reviews and two final COS will be published and freely available.
COMET study ID 1508.
脑膜瘤是成年人中最常见的原发性颅内肿瘤。大多数为良性，但有一部分表现出侵袭性。偶然发现/症状轻微的脑膜瘤通常通过连续影像学检查进行管理。有症状的脑膜瘤，即那些威胁到神经血管结构或影像学上有生长的脑膜瘤，通常作为一线治疗策略进行切除。对于临床状况较差的患者，或无法手术、残留或复发的患者，通常使用放射治疗作为一线或辅助治疗。目前尚无有效的药物治疗方法。脑膜瘤临床研究中测量和报告的结果存在异质性。将制定两个“核心结局集”（COS）：（COSMIC：干预）用于脑膜瘤临床疗效试验，（COSMIC：观察）用于偶然发现/未治疗的脑膜瘤的临床研究。
两项系统文献回顾和试验登记搜索将确定已发表和正在进行的（1）脑膜瘤临床疗效试验，以及（2）偶然发现/未治疗脑膜瘤的临床研究中测量和报告的结局。结局包括临床医生报告的、患者报告的、照顾者报告的和基于客观测试（如神经认知测试）的结局，以及进展和生存的测量。结局将进行去重和分类，以生成两个长列表。通过两项两轮国际修改后的 eDelphi 调查，对两个长列表进行优先级排序，调查对象包括脑膜瘤患者、医疗保健专业人员、研究人员以及照顾/支持角色的人员。通过两次为期一天的在线共识会议，对两个最终的 COS 进行批准，所有利益相关者群体都有代表参加。
本研究的进行已获得（英国）利物浦大学伦理委员会的批准。参与者将在参加 eDelphi 调查和共识会议之前获得电子同意书。两项系统文献回顾和两项最终的 COS 将发表并免费提供。
COMET 研究 ID 1508。
