Schneider Patricia, Evaniew Nathan, Rendon Juan Sebastian, McKay Paula, Randall R Lor, Turcotte Robert, Vélez Roberto, Bhandari Mohit, Ghert Michelle
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2016 May 24;6(5):e011780. doi: 10.1136/bmjopen-2016-011780.
Orthopaedic oncology researchers face several obstacles in the design and execution of randomised controlled trials, including finite fiscal resources to support the rising costs of clinical research and insufficient patient volume at individual sites. As a result, high-quality research to guide clinical practice has lagged behind other surgical subspecialties. A focused approach is imperative to design a research programme that is economical, streamlined and addresses clinically relevant endpoints. The primary objective of this study will be to use a consensus-based approach to identify research priorities for international clinical trials in orthopaedic oncology.
We will conduct a 3-phase modified Delphi method consisting of 2 sequential rounds of anonymous web-based questionnaires (phases I and II), and an in-person consensus meeting (phase III). Participants will suggest research questions that they believe are of particular importance to the field (phase I), and individually rate each proposed question on 5 criteria (phase II). Research questions that meet predetermined consensus thresholds will be brought forward to the consensus meeting (phase III) for discussion by an expert panel. Following these discussions, the expert panel will be asked to assign scores for each research question, and research questions meeting predetermined criteria will be brought forward for final ranking. The expert panel will then be asked to rank the top 3 research questions, and these 3 research questions will be distributed to the initial group of participants for validation.
An ethics application is currently under review with the Hamilton Integrated Research Ethics Board in Hamilton, Ontario, Canada. The results of this initiative will be disseminated through peer-reviewed publications and conference presentations.
骨科肿瘤学研究人员在设计和开展随机对照试验时面临若干障碍,包括用于支持临床研究成本不断上升的财政资源有限,以及各个研究地点的患者数量不足。因此,指导临床实践的高质量研究落后于其他外科亚专业。必须采取一种有针对性的方法来设计一个经济、精简且能解决临床相关终点问题的研究项目。本研究的主要目标是采用基于共识的方法来确定骨科肿瘤学国际临床试验的研究重点。
我们将开展一个分三个阶段的改良德尔菲法,包括两轮连续的基于网络的匿名问卷调查(第一阶段和第二阶段),以及一次面对面的共识会议(第三阶段)。参与者将提出他们认为对该领域特别重要的研究问题(第一阶段),并根据五个标准对每个提出的问题进行单独评分(第二阶段)。符合预定共识阈值的研究问题将被提交到共识会议(第三阶段),由专家小组进行讨论。在这些讨论之后,将要求专家小组为每个研究问题打分,符合预定标准的研究问题将被提交进行最终排名。然后将要求专家小组对排名前三的研究问题进行排序,并将这三个研究问题分发给最初的参与者群体进行验证。
目前,一份伦理申请正在加拿大安大略省汉密尔顿的汉密尔顿综合研究伦理委员会审核。该项目的结果将通过同行评审出版物和会议报告进行传播。