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HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial.

van Wijk RM, Boere-Boonekamp MM, Groothuis-Oudshoorn CG, van Vlimmeren LA, IJzerman MJ - Trials (2012)

Bottom Line: 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.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?ISRCTN18473161.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Health Technology and Services Research, Institute for Governance Studies, University of Twente, Enschede, The Netherlands. r.m.vanwijk@utwente.nl

ABSTRACT

Background: In 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/design: Pragmatic 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.

Discussion: HEADS 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 registration: ISRCTN18473161.

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Flow chart of participants in HEADS. Provisional data.
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Figure 1: Flow chart of participants in HEADS. Provisional data.

Mentions: The HEADS study is a two-armed pragmatic RCT nested in a cohort study (Figure‚ÄČ1). The intervention is redression helmet therapy; the control condition is no helmet therapy (allowing natural recovery). The study starts as a cohort study for children aged two to four months with a positional preference and/or skull deformation (T0). At five months of age (T5), follow-up assessments are performed and parents of children with a moderate to severe skull deformation are invited to participate in the RCT. Eligible children whose parents do not wish to enrol in the RCT are invited to join the non-randomised controlled trial (nRCT) that runs parallel to the RCT. In both studies, follow-up assessments are performed at eight (T8), twelve (T12) and twenty-four months (T24) of age.


HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial.

van Wijk RM, Boere-Boonekamp MM, Groothuis-Oudshoorn CG, van Vlimmeren LA, IJzerman MJ - Trials (2012)

Flow chart of participants in HEADS. Provisional data.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3475065&req=5

Figure 1: Flow chart of participants in HEADS. Provisional data.
Mentions: The HEADS study is a two-armed pragmatic RCT nested in a cohort study (Figure‚ÄČ1). The intervention is redression helmet therapy; the control condition is no helmet therapy (allowing natural recovery). The study starts as a cohort study for children aged two to four months with a positional preference and/or skull deformation (T0). At five months of age (T5), follow-up assessments are performed and parents of children with a moderate to severe skull deformation are invited to participate in the RCT. Eligible children whose parents do not wish to enrol in the RCT are invited to join the non-randomised controlled trial (nRCT) that runs parallel to the RCT. In both studies, follow-up assessments are performed at eight (T8), twelve (T12) and twenty-four months (T24) of age.

Bottom Line: 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.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?ISRCTN18473161.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Health Technology and Services Research, Institute for Governance Studies, University of Twente, Enschede, The Netherlands. r.m.vanwijk@utwente.nl

ABSTRACT

Background: In 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/design: Pragmatic 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.

Discussion: HEADS 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 registration: ISRCTN18473161.

Show MeSH
Related in: MedlinePlus