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科罗拉多州新生儿听力筛查项目,1992 - 1999年:迈向基于人群的有效普遍新生儿听力筛查的开端

The Colorado newborn hearing screening project, 1992-1999: on the threshold of effective population-based universal newborn hearing screening.

作者信息

Mehl Albert L, Thomson Vickie

机构信息

Colorado Infant Hearing Advisory Committee, Clinical Faculty, University of Colorado Health Sciences Center, Denver, Colorado, USA.

出版信息

Pediatrics. 2002 Jan;109(1):E7. doi: 10.1542/peds.109.1.e7.

Abstract

OBJECTIVE

Although previous studies have documented the feasibility and benefits of universal newborn hearing screening in selected hospitals, none have reviewed the effectiveness of regionally mandated participation of large numbers of hospitals with variable levels of motivation to succeed. The purpose of this study was to measure hospital participation and overall screening success in a statewide program for universal newborn hearing screening and to track improvements in program establishment and outpatient follow-up over time.

METHODS

Four Colorado hospitals began voluntarily performing hearing screening before hospital discharge on all newborns in 1992. By 1996, 26 Colorado hospitals were participating in universal newborn hearing screening. The publication of screening results from these early years served as a catalyst for legislation requiring increased hospital participation in establishing universal screening programs. Data systems were subsequently developed to improve statistical tracking and follow-up. Eight years' worth of cumulative study data as well as the results from calendar year 1999 (the year of greatest hospital participation) were reviewed for collective measures of successful screening and follow-up. Three hospitals did not initiate newborn hearing screening programs until after the study period ended in 1999. Of the 57 hospitals that were screening newborns in 1999, the chosen method of screening at 52 hospitals was automated auditory brainstem response testing; 3 hospitals used otoacoustic emission testing, and the remaining 2 hospitals used 2-stage screening. Hearing loss was defined as a threshold of 35 decibels or greater in 1 or both ears at the time of confirmatory testing.

RESULTS

During the full 8-year study period, 1992 to 1999, 148 240 newborns were screened. A total of 291 infants who were born during the study period received a diagnosis of congenital hearing loss. In this cohort of 291 children, the cumulative frequency of bilateral hearing loss was 71% (range: 48%-94% by calendar year), the frequency of sensorineural hearing loss was 82% (range: 67%-88%), and the frequency of 1 or more risk factors was 47% (range: 37%-61%). During calendar year 1999, a total of 63 590 births were recorded at 60 birthing hospitals in Colorado. The families of 263 (0.4%) of these newborns refused newborn hearing screening. Of the remaining 63 327 newborns, 87% (55 324 infants) were screened for hearing acuity before hospital discharge, a far greater percentage than the 19% of all newborns screened during the first 5 years of voluntary hospital participation, and approaching the American Academy of Pediatrics's recommendation of 95% of newborns completing hospital-based testing in a successful screening program. As a result of this statewide hearing screening program, congenital hearing loss was diagnosed in 86 Colorado newborns during 1999, representing an occurrence rate of approximately 1 affected child in every 650 newborns. In this group of 86 infants, 59 had bilateral sensorineural hearing loss, 17 had unilateral sensorineural hearing loss, 4 had bilateral conductive hearing loss, and 6 had unilateral conductive hearing loss. Mild hearing loss was present in 6 infants, moderate hearing loss was present in 42 infants, severe hearing loss was present in 33 infants, and profound hearing loss was present in the remaining 5 infants. Only 32 of the 86 affected newborns in 1999 had 1 or more risk factors for hearing loss subsequently identified. After failing an initial hospital-based screening at 1 of the 57 participating hospitals in 1999, 2.3% of infants screened (1283 newborns) were referred for follow-up testing, easily exceeding the standard of <4% recommended by the American Academy of Pediatrics. Similarly, the false-positive rate of 2.2% during 1999 exceeded the recommended standard of <3%. Of the infants who failed their initial screening, 76% (978 infants) had documented follow-up testing to confirm or exclude congenital hearing loss, a percentage significantly improved from a follow-up rate of 48% during the first 5 years of screening, although not yet achieving the standard of 95% recommended by the American Academy of Pediatrics. Nine participating hospitals, however, were able to document appropriate follow-up for 95% or more of the infants who failed their initial screening tests. The median age of diagnosis of congenital hearing loss during 1999 was 2.1 months; 71% of affected infants were identified by 3 months of age (the recommended standard for age of diagnosis), and 92% of affected newborns were identified by 5 months of age. Measures of screening success were compared for large, mid-sized, and small hospitals. Increasing hospital size, as measured by the number of births per year, was associated with an increasing percentage of newborns who were successfully screened. It was notable that smaller hospital size was associated with increased referral rates for follow-up testing, whereas larger hospital size was associated with the highest recapture rate for follow-up testing.

CONCLUSIONS

Universal screening for congenital hearing loss is demonstrated to be feasible in a large regional effort of legislatively mandated participation. The success of such an endeavor is dependent on educational efforts for community professionals, commitment on the part of program planners, and data systems that more accurately track and recall infants who fail initial hospital-based screening.

摘要

目的

尽管先前的研究已证明在部分医院开展新生儿听力普遍筛查的可行性和益处,但尚无研究评估在大量医院中推行区域强制参与且各医院积极性参差不齐的情况下该筛查的有效性。本研究旨在衡量全州范围内新生儿听力普遍筛查项目中的医院参与情况和总体筛查成功率,并追踪项目建立及门诊随访随时间的改善情况。

方法

1992年,科罗拉多州的四家医院开始自愿在所有新生儿出院前进行听力筛查。到1996年,科罗拉多州有26家医院参与了新生儿听力普遍筛查。这些早期筛查结果的公布成为推动立法要求更多医院参与建立普遍筛查项目的催化剂。随后开发了数据系统以改善统计追踪和随访。回顾了八年的累积研究数据以及1999年(医院参与度最高的年份)的结果,以获取成功筛查和随访的综合指标。有三家医院直到1999年研究期结束后才启动新生儿听力筛查项目。在1999年进行新生儿听力筛查的57家医院中,52家医院选择的筛查方法是自动听性脑干反应测试;3家医院使用耳声发射测试,其余2家医院使用两阶段筛查。听力损失定义为确诊测试时单耳或双耳阈值达到或超过35分贝。

结果

在1992年至1999年的整个八年研究期间,共筛查了148240名新生儿。共有291名在研究期间出生的婴儿被诊断为先天性听力损失。在这291名儿童中,双侧听力损失的累积发生率为71%(按日历年范围为48% - 94%),感音神经性听力损失的发生率为82%(范围为67% - 88%),有1个或更多风险因素的发生率为47%(范围为37% - 61%)。1999年,科罗拉多州60家分娩医院共记录了63590例出生。这些新生儿中,有263名(0.4%)的家庭拒绝进行新生儿听力筛查。在其余63327名新生儿中,87%(55324名婴儿)在出院前接受了听力敏锐度筛查,这一比例远高于医院自愿参与的前五年中所有新生儿筛查比例的19%,并接近美国儿科学会建议的成功筛查项目中95%的新生儿完成基于医院测试的比例。由于该全州范围的听力筛查项目,1999年科罗拉多州有86名新生儿被诊断为先天性听力损失,发生率约为每650名新生儿中有1名受影响儿童。在这86名婴儿中,59名患有双侧感音神经性听力损失,17名患有单侧感音神经性听力损失,4名患有双侧传导性听力损失,6名患有单侧传导性听力损失。6名婴儿为轻度听力损失,42名婴儿为中度听力损失,33名婴儿为重度听力损失,其余5名婴儿为极重度听力损失。1999年86名受影响的新生儿中,只有32名随后被确定有1个或更多听力损失风险因素。1999年,在57家参与筛查的医院中,有1家医院的新生儿初次筛查未通过后,2.3%(1283名新生儿)的筛查婴儿被转诊进行后续测试,轻松超过了美国儿科学会建议的<4%的标准。同样,1999年2.2%的假阳性率超过了建议的<3%的标准。在初次筛查未通过的婴儿中,76%(978名婴儿)有记录显示进行了后续测试以确认或排除先天性听力损失,这一比例较筛查前五年48%的随访率有显著提高,尽管尚未达到美国儿科学会建议的95%的标准。然而,有9家参与筛查的医院能够为95%或更多初次筛查未通过的婴儿提供适当的随访记录。1999年先天性听力损失的诊断中位年龄为2.1个月;71%的受影响婴儿在3个月大时被确诊(诊断年龄的建议标准),92%的受影响新生儿在5个月大时被确诊。比较了大型、中型和小型医院的筛查成功指标。以每年出生人数衡量,医院规模越大,成功筛查的新生儿比例越高。值得注意的是,医院规模越小,后续测试的转诊率越高,而医院规模越大,后续测试的重新召回率越高。

结论

先天性听力损失的普遍筛查在立法强制参与的大型区域努力中被证明是可行的。这样一项努力的成功取决于对社区专业人员的教育工作、项目规划者的承诺以及能更准确追踪和召回初次基于医院筛查未通过婴儿的数据系统。

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