Abstract
BackgroundIn The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls) aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation.Methods/designPragmatic randomised controlled trial (RCT) nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment). At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT); they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined.DiscussionHEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies.Besides these health outcomes, we will be able to address several methodological questions, e.g. do participants in an RCT represent the eligible target population and do outcomes of the RCT differ from outcomes found in the nRCT?Trial registrationISRCTN18473161.
Highlights
In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation
We will be able to address several methodological questions, e.g. do participants in an randomised controlled trial (RCT) represent the eligible target population and do outcomes of the RCT differ from outcomes found in the non-randomisedrandomised controlled trial (nRCT)?
When a child turns its head toward one side most of the time, this is defined as positional preference [1]
Summary
The HEADS trial is the first study to present an RCT on the long-term effects of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. As the decision for helmet therapy in the nRCT group was made by parents themselves, this will allow us to investigate the relationship between real-world decisions and treatment outcomes. This provides more information on the usefulness of data from nonrandomised compared to randomised studies, which is relevant in comparative effectiveness research.
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