Here Is the PICO Question I Was Thinking: for a 4 M Old Boy with Mild Plagiocephaly, Is

Critically Appraised Topic in Pediatrics

Lauren Clemson, Josh Hardy, Liz Weiss

DPT 781H; September 29, 2010

Nonsurgical treatment of deformational plagiocephaly: A systematic review

This is a systematic review of level 3b evidence. The authors concluded that molding/helmet therapy is more effective than repositioning to decrease head asymmetry in infants with deformational plagiocephaly. The evidence is inconclusive and of very poor quality with multiple biases potentially confounding the results. There needs to be more studies of higher methodological quality to assess the effectiveness of helmet therapy compared to repositioning therapy.

Citation: Xia J, Kennedy K, Teichgraeber J, et al. Nonsurgical treatment of deformational plagiocephaly: A systematic review. Arch Pediatr Adolesc Med. 2008;162(8):719-727

Lead Author’s name and fax: James J. Xia, MD, PhD, MS

PICO question: For a 4 month old male infant with mild plagiocephaly secondary to congenital muscular torticollis, is repositioning more effective than helmet therapy in decreasing head/facial asymmetry?

Search Terms: We searched the term “plagiocephaly” in the Cochrane database; our search resulted in zero Cochrane reviews but 3 other systematic reviews and 1 RCT. We then searched PubMed, CINAHL, and MEDLINE with the term “plagiocephaly.” No other systematic reviews, RCT’s, or cohort studies of high methodological quality were found.

This article was chosen over the 2 other systematic reviews because it was the most current and the infant fit within the population evaluated. The RCT was not chosen because having congenital muscular torticollis was one of the exclusion criteria and thus excluded the infant from the population researched.

The Review: The studies included in this review were 7 cohort studies. The studies were not analyzed for homogeneity of subjects or treatments.

Data Source: Cochrane Library

Study Selection: A total of 3793 references were retrieved from Cochrane, MEDLINE, ISI Web of Science, ScienceDirect, and Journal@Ovid. The authors also included a manual search of conference proceedings for nonsurgical treatment of plagiocephaly. No RCT’s were found; therefore, only cohort studies (level III evidence) were included. Other inclusion criteria were: the studies had to include infants who had deformational plagiocephaly with or without torticollis, infants who were healthy and did not have any underlying conditions that may affect the course of their plagiocephaly (i.e. craniosynostosis, congenital craniofacial deformities, and genetic disorders), infants who had received no previous treatment of their plagiocephaly, and the studies must have been designed to compare the effectiveness of molding (helmet) therapy versus another nonsurgical treatment for plagiocephaly. Eleven cohort studies met the inclusion criteria. Upon further investigation, 4 studies were excluded due to a lack of information on the cohort, articles sourced in more that one journal, and conference abstracts that were published at a later date. Therefore, a total of 7 studies were included in the critical review.

Data Extraction: In this systematic review, two reviewers independently appraised the methodological quality of the potential studies using a Critical Appraisal Skills Program critical review form for cohort studies. Three main questions were asked about the studies: Are the results of the studies valid? What are the results? Will the results help me locally? Furthermore, these 3 main questions were subdivided into 12 different questions. Finally, the magnitude of the effect in the individual studies was reported by a point estimate and a 95% confidence interval. The recruitment strategies, the exposure of the participants and families, the use of proper outcomes, the identification of possible confounding variables, and the follow-up period were evaluated to determine the robustness and the potential biases of each study.

The Evidence: Out of the 7 studies included in this review, only 5 studies used an objective outcome measure. These 5 studies found molding/helmet therapy to be more effective than repositioning therapy as determined by anthropometric measurements. A large selection bias was found in these studies that resulted in the more severe cases of plagiocephaly being placed in the molding therapy group. Furthermore, in the same 5 studies, masking of outcome assessment was not mentioned leaving room for measurement bias to occur. Two studies found repositioning therapy and remolding therapy to be equally effective in reducing asymmetries, but the treatment times for the repositioning therapy groups were significantly longer than treatment times for the molding therapy groups.

When determining the magnitude of the effects, 3 studies were excluded because the authors did not adequately report the number of subjects that had ‘normal’ head sizes post treatment. Another study was found to have significant measurement bias because the anthropometric measurements found in the molding group were significantly different than historical data of previously treated patients; therefore, it was not included in the measurement of the effect. One study was excluded from the analysis because the review authors could not determine whether the repositioning group received an intervention or if they were simply observed. Finally, in one study, infants in the repositioning group were crossed over to the molding group after failure of the original treatment. After these studies were excluded from the analysis of the effects, only one article remained to be included in the calculation of the treatment effects. The relative risk of molding therapy was 1.3 with a 95% confidence interval of 1.2-1.4. The absolute risk reduction for the infants that improved with molding therapy was 0.21 with a 95% confidence interval of 0.15-0.27. The number needed to treat was 5.0 (95% CI, 4-7).

Comments: The systematic review aimed to assess the current research on the effects of repositioning versus helmet, or molding, therapy in infants with plagiocephaly. There are no randomized control trails available on this topic, so the researchers limited their search to cohort studies. These types of studies are considered level 3b evidence and their results can not claim cause and effect. Seven studies were identified to meet the inclusion criteria of this review. Five of these studies concluded that helmet therapy was more effective than repositioning, while it was not possible to draw conclusions from the remaining 2 studies due to design flaws. Based on the results of 1 study (Graham et al), the authors concluded that 21% more patients would improve with helmet therapy than with repositioning.

This review concluded that, according to the expert opinion presented in many of the included studies, the treatment of choice for infants under 4 months of age, or with moderate or less plagiocephaly, is repositioning therapy. This therapy encourages the infant to spend time on the non-flattened side of their skull and in prone, as well as to continue any therapy for congenital muscular torticollis if appropriate. For infants between 4 and 6 months, the recommendations are controversial as to the preferred treatment; while for infants older than 6 months or with severe deformity, helmet therapy is preferred. However, it should be noted that none of the included studies in this review specifically evaluated treatment success based on infants’ age or severity of deformity. Additionally, there are many different methods of classifying skull deformity; this leads to difficulties comparing various study results, and many of the studies cited in this review failed to report their definition of mild, moderate, or severe deformity.

Clinical Application: The infant addressed in our PICO question is 4 months old and considered to have a mild skull deformity. Based on the literature presented in this systematic review, it can be concluded that this infant would potentially benefit from helmet therapy. However, expert opinion suggests that molding therapy should not be initiated until he is 6 months old if the deformity still exists. It should also be noted that all current recommendations are based on low-level evidence and many potential biases may exist. In this review, no risks were presented with the use of molding therapy. However, since helmet therapy is an expensive process that many insurance companies do not readily cover, at this time we can not recommend this treatment for the infant. Repositioning therapy is our recommended treatment, but it should be monitored to ensure effectiveness. This includes repeating skull deformity measures in a standardized way periodically and documenting changes in typical positioning and daily activity that are potentially encouraged by decreased deformity.

The current protocol for practice appears to match the recommendations presented in this systematic review. Currently, repositioning therapy seems to be the treatment of choice for most infants with plagiocephaly although this review found that helmet therapy might be a more effective treatment approach to increase skull symmetry. With the lack of high quality evidence supporting helmet therapy, it is currently not recommended except for older infants or in the case of severe deformity despite its potential benefits.

Clemson, Hardy, Weiss