疾病预防控制中心关于脊髓脊膜膨出新生儿和幼儿泌尿科及肾脏协议的设计和方法学考虑。
Design and Methodological Considerations of the Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida.
机构信息
Division of Urology, Duke University Medical Center, Durham, North Carolina.
Division of Urology, Lurie Children's Hospital of Chicago, Chicago, Illinois.
出版信息
J Urol. 2016 Dec;196(6):1728-1734. doi: 10.1016/j.juro.2016.07.081. Epub 2016 Jul 27.
PURPOSE
Care of children with spina bifida has significantly advanced in the last half century, resulting in gains in longevity and quality of life for affected children and caregivers. Bladder dysfunction is the norm in patients with spina bifida and may result in infection, renal scarring and chronic kidney disease. However, the optimal urological management for spina bifida related bladder dysfunction is unknown.
MATERIALS AND METHODS
In 2012 the Centers for Disease Control and Prevention convened a working group composed of pediatric urologists, nephrologists, epidemiologists, methodologists, community advocates and Centers for Disease Control and Prevention personnel to develop a protocol to optimize urological care of children with spina bifida from the newborn period through age 5 years.
RESULTS
An iterative quality improvement protocol was selected. In this model participating institutions agree to prospectively treat all newborns with spina bifida using a single consensus based protocol. During the 5-year study period outcomes will be routinely assessed and the protocol adjusted as needed to optimize patient and process outcomes. Primary study outcomes include urinary tract infections, renal scarring, renal function and bladder characteristics. The protocol specifies the timing and use of testing (eg ultrasonography, urodynamics) and interventions (eg intermittent catheterization, prophylactic antibiotics, antimuscarinic medications). Starting in 2014 the Centers for Disease Control and Prevention began funding 9 study sites to implement and evaluate the protocol.
CONCLUSIONS
The Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida began accruing patients in 2015. Assessment in the first 5 years will focus on urinary tract infections, renal function, renal scarring and clinical process improvements.
目的
在过去的半个世纪中，对脊柱裂儿童的护理有了显著的进步，这使得受影响的儿童和照顾者的寿命和生活质量都得到了提高。膀胱功能障碍是脊柱裂患者的常见症状，可能导致感染、肾脏瘢痕和慢性肾脏疾病。然而，脊柱裂相关膀胱功能障碍的最佳泌尿科治疗方法尚不清楚。
材料和方法
2012 年，疾病控制与预防中心召集了一个由儿科泌尿科医生、肾脏病学家、流行病学家、方法学家、社区倡导者和疾病控制与预防中心人员组成的工作组，制定了一项方案，以优化脊柱裂儿童从新生儿期到 5 岁的泌尿科护理。
结果
选择了一个迭代质量改进方案。在这种模式下，参与机构同意前瞻性地使用单一基于共识的方案治疗所有患有脊柱裂的新生儿。在 5 年的研究期间，将定期评估结果，并根据需要调整方案，以优化患者和流程结果。主要研究结果包括尿路感染、肾脏瘢痕、肾功能和膀胱特征。该方案规定了测试（例如超声检查、尿动力学）和干预（例如间歇性导尿、预防性抗生素、抗毒蕈碱药物）的时间和使用。从 2014 年开始，疾病控制与预防中心开始资助 9 个研究地点，以实施和评估该方案。
结论
疾病控制与预防中心的新生儿和幼儿脊柱裂泌尿科和肾脏方案于 2015 年开始入组患者。前 5 年的评估将集中在尿路感染、肾功能、肾脏瘢痕和临床流程改进上。
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