Congress of Neurological Surgeons Releases Evidence-based Guidelines for the Treatment of Pediatric Positional Plagio...
April 2018 Issue
The Congress of Neurological Surgeons (CNS) describes itself as "the leader in education and innovation, dedicated to advancing neurosurgery." Its mission statement goes on to explain, "We practice this by inspiring and facilitating scientific discovery and its translation to clinical practice for our members. The CNS provides its members with the educational and career development opportunities they need to become leaders and innovators in the field."1
In fulfillment of its mandate to translate scientific discovery into clinical practice, the CNS recently sponsored the development of a set of Open-Access Evidence-Based Guidelines for the Treatment of Pediatric Positional Plagiocephaly.2 The guidelines are substantial, with separate sections on the roles of imaging, repositioning, physical therapy, and cranial remolding orthosis (helmet) therapy.2
While the statements that comprise the guidelines are hardly novel, their strength is not so much what is said, but the evidence that supports those statements and the bodies that have elected to endorse them. In the case of the CNS guidelines, they have been endorsed by the Joint Guidelines Committee of the American Association of Neurological Surgeons (AANS) and the American Academy of Pediatrics (AAP).
This article highlights those guidelines specific to cranial remolding orthoses (CROs), addresses additional guidelines not related to CROs, and seeks to increase the profession's awareness of these important guidelines.
As with the other subsections of the guidelines, the recommendations on CROs begin with a thorough systematic review of the published literature and a grading of this evidence. In this case, this process yielded 15 publications including a single prospective randomized controlled trial (the now infamous Dutch trial), five prospective comparative studies, and nine retrospective comparative studies. These papers were synthesized into the following recommendations, each of which were assigned with Level II certainty.3
1. Helmet therapy is recommended for infants with persistent moderate to severe plagiocephaly after a course of conservative treatment (repositioning and/or physical therapy).
2. Helmet therapy is recommended for infants with moderate to severe plagiocephaly presenting at an advanced age.
These recommendations are later summarized and clarified in the authors' conclusion:
There is a fairly substantive body of non-randomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet as compared to conservative therapy, especially if the deformity is severe, and provided that helmet therapy is applied during the appropriate period of infancy.3
These statements of some certainty are balanced by the identification of those areas where the literature is thus far inconclusive:
Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly remain elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shapes.3
Helmet Therapy Is Recommended
The aberrant findings of the Dutch prospective randomized trial, treated in an earlier article ("The Rest of the Story." The O&P EDGE, March 2017), are addressed in part by the CNS authors' statements specific to the trial: "The conclusion of this trial stands in stark contrast to the remainder of the evidence uncovered during the course of this systematic review," and "The study does have some notable criticisms." In short, the Dutch findings are essentially dismissed from further consideration in the guideline.
Rather, the guideline recommendation is based on 12 Class II retrospective and prospective comparative studies that "provide evidence in support of the notion that helmet therapy results in better outcomes than conservative therapy in infants with positional plagiocephaly."3
Those familiar with earlier systematic reviews on the efficacy of CROs will recognize the authors' identification of a selection bias and contamination bias, both of which consistently work against CROs. The selection bias is pervasive in non-randomized studies where infants assigned to CROs tend to be older infants with more severe cranial deformities. The contamination bias occurs throughout the literature in cases where infants who were initially in the conservative therapy group experience subsatisfactory results and then enter the helmet group. However, despite these common biases, both of which would appear to work against CRO outcomes, the larger improvements continue to occur more quickly with CROs.
The recommendation that "helmet therapy is recommended for infants with moderate to severe plagiocephaly presenting at an advanced age" must be read within the context of the full guidelines. The authors explain:
Although the data were not robust enough to definitively determine the optimal time window in infancy for treatment of positional plagiocephaly with helmet therapy, it does appear that the earlier an infant is placed in a helmet, the better the treatment outcome. That being said, it must be remembered that young infants with positional plagiocephaly may see an improvement in cranial symmetry with conservative therapy or simply observation.
So, while the guidelines do not clearly define when helmet treatment should begin, the statement "presenting at an advanced age," is relative to the ages of the infants in the identified literature. Within this recommendation, the authors cite two studies in which the efficacy of helmet therapy begins to decline at six and nine months respectively.3
While considerations such as imaging and physical therapy are outside the immediate purview of the clinical orthotist, it is certainly valuable to understand any recommendations for other members of a rehabilitation team.
With respect to imaging, the guidelines assert, "Clinical examination is recommended for the diagnosis of plagiocephaly and imaging is rarely necessary, except in cases in which clinical diagnosis is equivocal."2
They go on to state that x-rays or ultrasound are recommended when clinical examination is uncertain. Surface imaging and stereophotogrammetry are also recommended in such cases, though with reduced clinical certainty. When x-rays or ultrasound are inconclusive, CT scans are recommended for definitive diagnosis.
With respect to repositioning, a single recommendation states:
Repositioning is an effective treatment for deformational plagiocephaly. However, there is Class I evidence from a single study and Class II evidence from several studies that repositioning is inferior to physical therapy and to use of a helmet, respectively.2
These statements relative to physical therapy and helmet use are supported by high and moderate clinical certainty respectively.
With respect to physical therapy, two recommendations are made:
• Physical therapy is recommended over repositioning education alone for reducing prevalence of infantile positional plagiocephaly in infants seven weeks of age.
• Physical therapy is as effective for the treatment of positional plagiocephaly and recommended over the use of a positioning pillow to ensure a safe sleeping environment and comply with American Academy of Pediatrics recommendations.2
The current healthcare environment is increasingly directed by evidence-based practice guidelines. As such, healthcare providers must know and understand these guidelines as they are released. This working knowledge provides defensible statements during the education of third-party payers, referral sources, and the family members of prospective patients. Within this mindset, the CNS guidelines become a valuable resource for those practicing cranial orthotic care.
Phil Stevens, MEd, CPO, FAAOP, is in clinical practice with Hanger Clinic, Salt Lake City. He can be contacted at firstname.lastname@example.org.
1. www.cns.org/about-us. Accessed on 1/20/2018.
2. www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly. Accessed on 1/20/2018.
3. www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5. Accessed on 1/20/2018.