METHODS: A two-round online modified Delphi study was conducted with an inter-disciplinary panel of musculoskeletal researchers from Australia and Aotearoa New Zealand, representing various career stages and roles, including clinician researchers and consumers with lived experience of musculoskeletal conditions. Round 1 involved panellists nominating 3-10 topics about musculoskeletal trial design and conduct that they believe would be important to include in an e-learning course about musculoskeletal clinical trials. Topics were synthesised and refined. Round 2 asked panellists to rate the importance of all topics (very important, important, not important), as well as select and rank their top 10 most important topics. A rank score was calculated whereby higher scores reflect higher rankings by panellists.
RESULTS: Round 1 was completed by 121 panellists and generated 555 individual topics describing their musculoskeletal trial learning needs. These statements were grouped into 37 unique topics for Round 2, which was completed by 104 panellists. The topics ranked as most important were: (1) defining a meaningful research question (rank score 560, 74% of panellists rated topic as very important); (2) choosing the most appropriate trial design (rank score 410, 73% rated as very important); (3) involving consumers in trial design through to dissemination (rank score 302, 62% rated as very important); (4) bias in musculoskeletal trials and how to minimise it (rank score 299, 70% rated as very important); and (5) choosing the most appropriate control/comparator group (rank score 265, 65% rated as very important).
CONCLUSIONS: This modified Delphi study generated a ranked list of clinical trial learning needs of musculoskeletal researchers. Findings can inform training courses and professional development to improve researcher capabilities and enhance the quality and conduct of musculoskeletal clinical trials.
方法:与来自澳大利亚和新西兰奥特罗阿的肌肉骨骼研究人员组成的跨学科小组进行了两轮在线改良Delphi研究,代表不同的职业阶段和角色,包括临床医生研究人员和有肌肉骨骼疾病生活经验的消费者。第1轮涉及小组成员提名3-10个有关肌肉骨骼试验设计和行为的主题,他们认为将其纳入有关肌肉骨骼临床试验的电子学习课程中很重要。主题是综合和完善的。第2轮要求小组成员对所有主题的重要性进行评分(非常重要,重要的,不重要),以及选择和排名他们的前10个最重要的话题。计算等级分数,由此较高的分数反映小组成员的较高排名。
结果:第1轮由121名小组成员完成,产生555个主题,描述他们的肌肉骨骼试验学习需求。这些发言被分为第二轮的37个独特主题,由104名小组成员完成。被评为最重要的主题是:(1)定义一个有意义的研究问题(等级得分560,74%的小组成员将主题评为非常重要);(2)选择最合适的试验设计(等级得分410,73%被评为非常重要);(3)使消费者参与试验设计直到传播(等级得分302,62%被评为非常重要);(4)肌肉骨骼试验中的偏见以及如何将其评为最重要的对照组(65%
结论:这项改良的Delphi研究产生了肌肉骨骼研究人员的临床试验学习需求的排名列表。研究结果可以为培训课程和专业发展提供信息,以提高研究人员的能力并提高肌肉骨骼临床试验的质量和进行。