Shanghai Baoshan Luodian Hospital, Shanghai, China.
Department of Orthopedic, Longhua Hospital, Shanghai University of Traditional Chinese Medicinev, Shanghai, China.
BMJ Open. 2024 Sep 10;14(9):e083315. doi: 10.1136/bmjopen-2023-083315.
In recent years, the incidence of spinal metastasis (SM) has been increasing steadily. In response to this serious public health problem, researchers have made progress by using the integration of traditional Chinese and Western medicine. However, considerable heterogeneity in the definition and measurement of outcomes across clinical research studies, along with the lack of uniform measurement standards for study data, makes it difficult for researchers to compare different treatments. Therefore, it is crucial to accurately evaluate clinical research on the integration of traditional Chinese and Western medicine for SM.
This study protocol outlines a comprehensive research programme based on the Core Outcome Set Standards Protocol Items. The study consists of four phases: a literature review, semistructured interviews, a two-round modified Delphi survey, a consensus meeting. Phase 1 involves a comprehensive literature review to extract outcomes used in current clinical studies of integrated traditional Chinese and Western medicine or Western medicine for the treatment of SM. A semistructured interview format will be used to survey patients and caregivers in phase 2 to collect suggestions from the patient perspective. Phase 3 involves a two-round modified Delphi survey to complete a prioritisation evaluation of outcomes to generate a candidate list for core outcome set (COS). Finally, phase 4 involves a face-to-face consensus meeting to review and establish the COS.
Conducted in response to the current dilemma of SM, the study was endorsed by the Spine Oncology Group of the Orthopaedic Surgeons Branch of the Chinese Physicians' Association. It will be developed and reported through a rigorous process, with the results of the study to be published in a peer-reviewed journal. COMET Registry: COMET 2938; https://www.comet-initiative.org/Studies/Details/2938.
近年来，脊柱转移瘤（SM）的发病率呈稳步上升趋势。针对这一严重的公共卫生问题，研究人员通过中西医结合取得了进展。然而，由于临床研究中对结局的定义和测量存在相当大的异质性，以及缺乏对研究数据的统一测量标准，研究人员难以比较不同的治疗方法。因此，准确评估 SM 的中西医结合临床研究至关重要。
本研究方案基于核心结局集标准协议项目概述了一项全面的研究计划。该研究包括四个阶段：文献综述、半结构化访谈、两轮改良 Delphi 调查、共识会议。第 1 阶段涉及全面的文献综述，以提取当前中西医结合治疗 SM 的临床研究或西医治疗中使用的结局。第 2 阶段将采用半结构化访谈形式调查患者和护理人员，从患者角度收集建议。第 3 阶段涉及两轮改良 Delphi 调查，以完成对结局的优先评估，生成核心结局集（COS）候选清单。最后，第 4 阶段涉及面对面的共识会议，以审查和建立 COS。
本研究是为了应对 SM 的当前困境而进行的，得到了中华医师协会骨科医师分会脊柱肿瘤学组的认可。它将通过严格的流程进行开发和报告，研究结果将发表在同行评议的期刊上。COMET 注册表：COMET 2938；https://www.comet-initiative.org/Studies/Details/2938。
