Ultrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures
Peter J. Snelling, Philip Jones, David Bade, et al
N Engl J Med 2023; 388:2049-2057
DOI: 10.1056/NEJMoa2213883
Abstract
BACKGROUND
Data on whether ultrasonography for the initial diagnostic imaging of forearm fractures in children and adolescents is noninferior to radiography for subsequent physical function of the arm are limited.
背景
作为儿童和青少年前臂骨折的初始影像学诊断方法，有关超声检查在后续手臂功能方面是否不劣于X线检查的研究数据有限。
METHODS
In this open-label, multicenter, noninferiority, randomized trial in Australia, we recruited participants 5 to 15 years of age who presented to the emergency department with an isolated distal forearm injury, without a clinically visible deformity, in whom further evaluation with imaging was indicated. Participants were randomly assigned to initially undergo point-of-care ultrasonography or radiography, and were then followed for 8 weeks. The primary outcome was physical function of the affected arm at 4 weeks as assessed with the use of the validated Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) score (range, 8 to 40, with higher scores indicating better function); the noninferiority margin was 5 points.
方法在澳大利亚开展的这项开放标签、多中心、非劣效性、随机试验中，我们纳入了因孤立性前臂远端损伤到急诊科就诊，无临床可见变形，且需要进一步影像学评估的5~15岁参与者。参与者被随机分组，最初接受床旁超声检查或X线检查，然后接受8周随访。主要结局是第4周时，使用经过验证的儿童上肢简易（Pediatric Upper Extremity Short）患者报告结局测量信息系统（Patient-Reported Outcomes Measurement Information System，PROMIS）评分（范围，8~40，评分较高表示功能较好）评估患肢生理功能；非劣效性界值为5分。
RESULTS
A total of 270 participants were enrolled, with outcomes for 262 participants (97%) available at 4 weeks (with a window of ±3 days) as prespecified. PROMIS scores at 4 weeks in the ultrasonography group were noninferior to those in the radiography group (mean, 36.4 and 36.3 points, respectively; mean difference, 0.1 point; 95% confidence interval [CI], −1.3 to 1.4). Intention-to-treat analyses (in 266 participants with primary outcome data recorded at any time) produced similar results (mean difference, 0.1 point; 95% CI, −1.3 to 1.4). No clinically important fractures were missed, and there were no between-group differences in the occurrence of adverse events.
结果
本试验共计纳入270例参与者，并在第4周（±3日时间窗）时获得了其中262例（97%）的预设结局。超声检查组第4周时的PROMIS评分不劣于X线检查组（均值，分别为36.4分和36.3分；平均差异，0.1分；95%置信区间[CI]，－1.3~1.4）。意向性治疗分析（在任一时间记录了主要结局数据的266例参与者中）产生了相似结果（平均差异，0.1分；95% CI，－1.3~1.4）。未发生临床重要骨折被漏诊的情况，不良事件发生率无组间差异。
CONCLUSIONS
In children and adolescents with a distal forearm injury, the use of ultrasonography as the initial diagnostic imaging method was noninferior to radiography with regard to the outcome of physical function of the arm at 4 weeks. (Funded by the Emergency Medicine Foundation and others; BUCKLED Australian New Zealand Clinical Trials Registry number, ACTRN12620000637943. opens in new tab).
结论
在前臂远端损伤的儿童和青少年中，在第4周时的手臂生理功能结局方面，作为初始影像学诊断方法，超声检查不劣于X线检查。（由急诊医学基金会[Emergency Medicine Foundation]等资助；BUCKLED澳大利亚新西兰临床试验注册号为ACTRN12620000637943）。
