Elbourne Diana, Dezateux Carol, Arthur Rosemary, Clarke N M P, Gray Alastair, King Andy, Quinn Anne, Gardner Frances, Russell Glynn
Medical Statistics Unit, London School of Hygiene and Tropical Medicine, UK.
Lancet. 2002;360(9350):2009-17. doi: 10.1016/s0140-6736(02)12024-1.
Clinical screening aims to identify and treat neonatal hip instability associated with increased risk of hip displacement, but risks failures of diagnosis and treatment (abduction splinting), iatrogenic effects, and costs to parents and health services. Our objectives were to assess clinical effectiveness and net cost of ultrasonography compared with clinical assessment alone, to provide guidance for management of infants with clinical hip instability.
Infants with clinical hip instability were recruited from 33 centres in UK and Ireland and randomised to either ultrasonographic hip examination (n=314) or clinical assessment alone (n=315). The primary outcome was appearance on hip radiographs by 2 years. Secondary outcomes included surgical treatment, abduction splinting, level of mobility, resource use, and costs. Analysis was by intention to treat.
Protocol compliance was high, and radiographic information was available for 91% of children by 12-14 months and 85% by 2 years. By age 2 years, subluxation, dislocation, or acetabular dysplasia were identified by radiography on one or both hips of 21 children in each of the groups (relative risk 1.00; 95% CI 0.56-1.80). Fewer children in the ultrasonography group had abduction splinting in the first 2 years than did those in the no-ultrasonography group (0.78; 0.65-0.94; p=0.01). Surgical treatment was required by 21 infants in the ultrasonography group (6.7%) and 25 (7.9%) in the no-ultrasonography group (0.84; 0.48-1.47). One child from the ultrasonography group and four from the no-ultrasonography group were not walking by 2 years (0.25; 0.03-2.53; p=0.37). Infants in the ultrasonography group incurred significantly higher ultrasound costs over the first 2 years (pound 42 vs pound 23, mean difference pound 19, 95% CI 11-27); total hospital costs were lower for those infants, but the difference was not significant.
The use of ultrasonography in infants with screen-detected clinical hip instability allows abduction splinting rates to be reduced, and is not associated with an increase in abnormal hip development, higher rates of surgical treatment by 2 years of age, or significantly higher health-service costs.
临床筛查旨在识别并治疗与髋关节脱位风险增加相关的新生儿髋关节不稳定,但存在诊断和治疗(外展夹板固定)失败、医源性影响以及给家长和医疗服务带来成本的风险。我们的目标是评估超声检查与单纯临床评估相比的临床效果和净成本,为临床髋关节不稳定婴儿的管理提供指导。
从英国和爱尔兰的33个中心招募临床髋关节不稳定的婴儿,随机分为超声髋关节检查组(n = 314)或单纯临床评估组(n = 315)。主要结局是2岁时髋关节X线片的表现。次要结局包括手术治疗、外展夹板固定、活动水平、资源使用和成本。分析采用意向性分析。
方案依从性高,12 - 14个月时91%的儿童可获得X线片信息,2岁时为85%。到2岁时,两组中各有21名儿童的一侧或双侧髋关节通过X线片被诊断为半脱位、脱位或髋臼发育不良(相对风险1.00;95%置信区间0.56 - 1.80)。超声检查组在前两年接受外展夹板固定的儿童少于非超声检查组(0.78;0.65 - 0.94;p = 0.01)。超声检查组有21名婴儿(6.7%)需要手术治疗,非超声检查组有25名(7.9%)(0.84;0.48 - 1.47)。超声检查组有1名儿童、非超声检查组有4名儿童在2岁时仍不会走路(0.25;0.03 - 2.53;p = 0.37)。超声检查组的婴儿在头两年产生的超声检查成本显著更高(42英镑对23英镑,平均差值19英镑,95%置信区间11 - 27);这些婴儿的总住院成本较低,但差异不显著。
对筛查发现临床髋关节不稳定的婴儿使用超声检查可降低外展夹板固定率,且与髋关节异常发育增加、2岁时手术治疗率升高或医疗服务成本显著增加无关。