Ukoumunne Obioha C, Hyde Chris, Ozolins Mara, Zhelev Zhivko, Errington Sam, Taylor Rod S, Benton Claire, Moody Joanne, Cocking Laura, Watson Julian, Fortnum Heather
NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, South Cloisters, St Luke's Campus, Exeter, UK.
Institute of Health Research, University of Exeter Medical School Luke's Campus, Exeter, UK.
BMJ Open. 2017 Jul 11;7(7):e017258. doi: 10.1136/bmjopen-2017-017258.
This study directly compared the accuracy of two audiometry-based tests for screening school children for hearing impairment: the currently used test, pure tone screen and a device newly applied to children, HearCheck Screener.
Two-gate case-control diagnostic test accuracy study.
Hearing impaired children ('intended cases') aged 4-6 years were recruited between February 2013 and August 2014 from collaborating audiology services. Children with no previously identified impairment ('intended controls') were recruited from Foundation and Year 1 of schools between February 2013 and June 2014 in central England. The reference standard was pure tone audiometry. Tests were administered at Nottingham Hearing Biomedical Research Unit or, for some intended cases only, in the participant's home.
Sensitivity and specificity of the pure tone screen and HearCheck tests based on pure tone audiometry result as reference standard.
315 children (630 ears) were recruited; 75 from audiology services and 240 from schools. Full test and reference standard data were obtained for 600 ears; 155 ears were classified as truly impaired and 445 as truly hearing based on the pure tone audiometry assessment. Sensitivity was estimated to be 94.2% (95% CI 89.0% to 97.0%) for pure tone screen and 89.0% (95% CI 82.9% to 93.1%) for HearCheck (difference=5.2% favouring pure tone screen; 95% CI 0.2% to 10.1%; p=0.02). Estimates for specificity were 82.2% (95% CI 77.7% to 86.0%) for pure tone screen and 86.5% (95% CI 82.5% to 89.8%) for HearCheck (difference=4.3% favouring HearCheck; 95% CI0.4% to 8.2%; p=0.02).
Pure tone screen was better than HearCheck with respect to sensitivity but inferior with respect to specificity. As avoiding missed cases is arguably of greater importance for school entry screening, pure tone screen is probably preferable in this context.
Current controlled trials: ISRCTN61668996.
本研究直接比较了两种基于听力测试的方法在筛查学童听力障碍方面的准确性：目前使用的纯音筛查测试，以及一种新应用于儿童的设备——听力检查筛查仪（HearCheck Screener）。
双门病例对照诊断测试准确性研究。
2013年2月至2014年8月期间，从合作的听力学服务机构招募了4至6岁的听力受损儿童（“预期病例”）。2013年2月至2014年6月期间，在英格兰中部地区从小学一年级和基础班招募了此前未发现有听力障碍的儿童（“预期对照”）。参考标准为纯音听力测定。测试在诺丁汉听力生物医学研究单位进行，或仅对部分预期病例在参与者家中进行。
以纯音听力测定结果为参考标准，评估纯音筛查和听力检查测试的敏感性和特异性。
共招募了315名儿童（630只耳朵）；其中75名来自听力学服务机构，240名来自学校。获得了600只耳朵的完整测试和参考标准数据；根据纯音听力测定评估，155只耳朵被归类为真正受损，445只耳朵为真正听力正常。纯音筛查的敏感性估计为94.2%（95%置信区间89.0%至97.0%），听力检查筛查仪的敏感性为89.0%（95%置信区间82.9%至93.1%）（差异=5.2%，纯音筛查更具优势；95%置信区间0.2%至10.1%；p=0.02）。纯音筛查的特异性估计为82.2%（95%置信区间77.7%至86.0%），听力检查筛查仪的特异性为86.5%（95%置信区间82.5%至89.8%）（差异=4.3%，听力检查筛查仪更具优势；95%置信区间0.4%至8.2%；p=0.02）。
在敏感性方面，纯音筛查优于听力检查筛查仪，但在特异性方面则较差。由于在入学筛查中避免漏诊病例可能更为重要，因此在这种情况下，纯音筛查可能更可取。
当前对照试验：ISRCTN61668996。
