Department of Orthopaedics, China Academy of Chinese Medical Sciences, Wangjing Hospital, No. 6 Zhonghuannanlu, Chaoyang District, Beijing, 100102, China.
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China.
J Orthop Surg Res. 2019 Oct 9;14(1):317. doi: 10.1186/s13018-019-1364-x.
This study aimed to develop a core outcome set (COS) for clinical trials of joint-preserving treatment for osteonecrosis of the femoral head (ONFH), that is, to define a minimal set of outcomes that should be reported in such trials.
A mixed research method was adopted in this study. First, clinical trials of hip preservation therapy were systematically researched and analyzed. Second, a three-round Delphi survey involving both doctors and patients was carried out to obtain the core outcome indicators. Round 1 was a modified Delphi questionnaire for doctors and patients to determine which outcomes are important to these stakeholders, round 2 determined what clinical evaluation core outcomes should be included for the joint-preserving treatment of ONFH, and round 3 determined how core outcomes should be measured. Finally, a consensus meeting was held to discuss and vote on the established COS.
The results of the systematic review showed that 42 outcome indicators were classified according to common signs and symptoms, quality of life, long-term outcomes, radiological evaluation, blood biochemistry, and indexes of safety. The three rounds of Delphi surveys completed the selection of indicators for the COS and the determination of the corresponding measurements. A total of 73 orthopedic doctors and 103 patients participated in round 1, and the top 10 indicators selected were basically the same. In round 2, 32 experts identified the following indicators: pain, range of motion (ROM) of hip flexion, walking distance, and stable rating of X-ray images. In round 3, 35 experts defined the measurement of each indicator. Finally, the consensus meeting identified the four indicators aforementioned that constituted the COS. The scores for pain, ROM of hip flexion, and walking distance are from 0 to 10; 0 represents the best scores, while 10 represents the most serious impairment. The stable rating of X-ray images is determined by the morphology of the femoral head and the change in the density of the necrotic area.
We established a COS for hip-preserving treatment of ONFH that includes four indicators: pain, ROM of hip flexion, walking distance, and stable rating of X-ray images.
本研究旨在为保髋治疗股骨头坏死（ONFH）的临床试验制定一个核心结局集（COS），即定义应在这些试验中报告的最小结局集。
本研究采用混合研究方法。首先，对保髋治疗的临床试验进行系统研究和分析。其次，进行了三轮涉及医生和患者的 Delphi 调查，以获得核心结局指标。第一轮是针对医生和患者的改良 Delphi 问卷，以确定哪些结局对这些利益相关者重要，第二轮确定保髋治疗 ONFH 的临床评估核心结局应包括哪些，第三轮确定应如何测量核心结局。最后，召开共识会议讨论和投票确定确立的 COS。
系统评价结果显示，42 个结局指标根据常见的体征和症状、生活质量、长期结局、影像学评估、血液生化和安全性指标进行分类。三轮 Delphi 调查完成了 COS 指标的选择和相应测量的确定。共有 73 名骨科医生和 103 名患者参加了第一轮，选出的前 10 项指标基本相同。在第二轮中，32 名专家确定了以下指标：疼痛、髋关节屈曲活动度（ROM）、步行距离和 X 线图像稳定评分。在第三轮中，35 名专家定义了每个指标的测量方法。最后，共识会议确定了构成 COS 的上述四个指标。疼痛、髋关节屈曲 ROM 和步行距离的评分范围为 0 至 10；0 代表最好的分数，而 10 代表最严重的损伤。X 线图像的稳定评分由股骨头形态和坏死区域密度变化决定。
我们为保髋治疗 ONFH 制定了一个 COS，包括四个指标：疼痛、髋关节屈曲 ROM、步行距离和 X 线图像稳定评分。
