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

Abstract

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.

The National Spina Bifida Patient Registry: A Decade's journey

“…Routh et al () described utilizing iterative quality improvement methods to develop a protocol to optimize urological care of children from the newborn period through age 5 years. In this model, starting in 2014, the participating nine study sites agreed to prospectively treat all newborns using the single consensus‐based protocol.…”

“…The primary study outcomes were urinary tract infections, renal scarring, renal function, and bladder characteristics. During the 5‐year study period, the participating institution will be assessed and the protocol will be adjusted as needed to optimize patient and process outcomes (Routh et al, ).…”

The National Spina Bifida Patient Registry: Past, present, and future

“…A description of the methods for developing and refining a urologic protocol for newborns and young children with spina bifida has also been published [6]. A paper titled, “Factors Associated with Pressure Ulcers in Individuals with Spina Bifida” [7] provides an example of how Registry data have been used to identify and promote improved care, and will be described in more detail below.…”

“…Analysis of Registry data by Kim and colleagues [6] quantified the incidence of skin breakdowns reported between 2009 and 2012 among Registry participants at 26%; on their most recent visit, 19% of patients > 2 years old had skin breakdown.…”

Nevrogene blæreforstyrrelser hos barn

“…Ved behov vil derfor bestemmelse av glomerulaer filtrasjonsrate (GFR) vaere gullstandard for å måle nyrefunksjon, saerlig hos barn som har pareser og redusert muskelmasse i underekstremiteter. Alternativt kan man måle cystatin C, som i mange studier har vist en god korrelasjon til glomerulaer filtrasjonsrate og er uavhengig av muskelmasse (13,14).…”