The New England journal of medicine · 2023
Ultrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures.
Equivalence TrialСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Snelling Peter J, Jones Philip, Bade David, Bindra Randy, Byrnes Joshua, Davison Michelle, George Shane, Moore Mark, Keijzers Gerben, Ware Robert S, BUCKLED Trial Group
Аннотация
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.
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.
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.
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).
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.
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.
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).