BMJ Baby Helmet Study "Misleading," Experts at Technology in Motion Claim
Critique of the recently published study on plagiocephaly treatment in the British Medical Journal. The Dutch report is said by experts to be fundamentally flawed.
Leeds, United Kingdom, May 12, 2014 --(PR.com)-- Leading clinicians and healthcare professionals all over the world are hitting out against a report published in the British Medical Journal last week.
The Dutch study (1) investigated the success rate of plagiocephaly treatment. Also known as flat head syndrome, plagiocephaly is a head shape deformity often seen in babies, treated in severe cases using a special kind of corrective helmet.
The report concludes that helmets make no meaningful difference to the head shape, and can cause unpleasant side effects including sweating and skin irritation. However, experts have identified several flaws in the research procedure that completely undermine these conclusions.
In particular they condemned the uncomfortable, poor-fitting helmets that were used in the study. These rubbed and rotated, causing inflammation and dramatically reducing the treatment’s efficacy. Comparisons were drawn with helmets from legitimate clinics, which are generally custom fitted.
It may come as little surprise that the study had an drop-out rate of around 70%. The report states that 66% of infants ended treatment early, with only 27% expressing satisfaction with the results (2). Amazingly, those subjects who abandoned treatment early continued to be reported as part of the treated group and were regarded as having received fully successful treatments.
To compound matters further, the group failed to take into account the statistical range of head shape deformity in the population. Most clinics only treat those babies whose heads are within the ‘moderate’ to ‘severe’ range – a tiny percentage of the population. Many of those in the untreated group would have had ‘mild’ plagiocephaly, which is already known to correct itself in most cases.
Steve Mottram, Managing Director and Consultant Orthotist at Technology in Motion, one of the UK’s top plagiocephaly clinics, said:
"The way that the data has been presented mixes all head shape deformities and therefore minimises the specific effect for each type. It’s like reporting on 10 children who had broken arms and 10 who had broken legs. Combining the data ‘proves’ that only 50% of children with fractures recovered from a broken arm. The way that the data has been presented makes it meaningless and in this case, huge and misleading assumptions have been drawn from the results."
Plagiocephaly helmets are currently unavailable on the NHS on the grounds that the condition is cosmetic and usually sorts itself out (3). However, a significant number of parents continue to pay the £2,000 fee for treatment at a private practice – and are generally very pleased with the results.
Many physicians now agree that some babies can only be treated using a helmet. However, a considerable lack of research has prevented a definitive standard of care from being established in the UK (4).
To assess the true success rate of helmets, a reliable randomised controlled clinical trial or comparative study is needed. Until then, this area of research remains somewhat grey.
Technology in Motion has successfully treated thousands of babies over their ten years in practice, with excellent correction rates seen in over 95% of patients. Visit their website or call 0113 218 8030 to enquire further or for more information on their products and services.
References
1. Helmet therapy in infants with positional skull deformation: randomised controlled trial - BMJ 2014;348:g2741
2. Helmet therapy in infants with positional skull deformation: randomised controlled trial - BMJ 2014;348:g2741
3. Plagiocephaly (Flat Head Syndrome) Purely a Cosmetic Concern? - Whiz News Hub, 3 July 2013
4. Head Deformity Ignites Debate Among Baby Experts - LiveScience, 18 March 2011
The Dutch study (1) investigated the success rate of plagiocephaly treatment. Also known as flat head syndrome, plagiocephaly is a head shape deformity often seen in babies, treated in severe cases using a special kind of corrective helmet.
The report concludes that helmets make no meaningful difference to the head shape, and can cause unpleasant side effects including sweating and skin irritation. However, experts have identified several flaws in the research procedure that completely undermine these conclusions.
In particular they condemned the uncomfortable, poor-fitting helmets that were used in the study. These rubbed and rotated, causing inflammation and dramatically reducing the treatment’s efficacy. Comparisons were drawn with helmets from legitimate clinics, which are generally custom fitted.
It may come as little surprise that the study had an drop-out rate of around 70%. The report states that 66% of infants ended treatment early, with only 27% expressing satisfaction with the results (2). Amazingly, those subjects who abandoned treatment early continued to be reported as part of the treated group and were regarded as having received fully successful treatments.
To compound matters further, the group failed to take into account the statistical range of head shape deformity in the population. Most clinics only treat those babies whose heads are within the ‘moderate’ to ‘severe’ range – a tiny percentage of the population. Many of those in the untreated group would have had ‘mild’ plagiocephaly, which is already known to correct itself in most cases.
Steve Mottram, Managing Director and Consultant Orthotist at Technology in Motion, one of the UK’s top plagiocephaly clinics, said:
"The way that the data has been presented mixes all head shape deformities and therefore minimises the specific effect for each type. It’s like reporting on 10 children who had broken arms and 10 who had broken legs. Combining the data ‘proves’ that only 50% of children with fractures recovered from a broken arm. The way that the data has been presented makes it meaningless and in this case, huge and misleading assumptions have been drawn from the results."
Plagiocephaly helmets are currently unavailable on the NHS on the grounds that the condition is cosmetic and usually sorts itself out (3). However, a significant number of parents continue to pay the £2,000 fee for treatment at a private practice – and are generally very pleased with the results.
Many physicians now agree that some babies can only be treated using a helmet. However, a considerable lack of research has prevented a definitive standard of care from being established in the UK (4).
To assess the true success rate of helmets, a reliable randomised controlled clinical trial or comparative study is needed. Until then, this area of research remains somewhat grey.
Technology in Motion has successfully treated thousands of babies over their ten years in practice, with excellent correction rates seen in over 95% of patients. Visit their website or call 0113 218 8030 to enquire further or for more information on their products and services.
References
1. Helmet therapy in infants with positional skull deformation: randomised controlled trial - BMJ 2014;348:g2741
2. Helmet therapy in infants with positional skull deformation: randomised controlled trial - BMJ 2014;348:g2741
3. Plagiocephaly (Flat Head Syndrome) Purely a Cosmetic Concern? - Whiz News Hub, 3 July 2013
4. Head Deformity Ignites Debate Among Baby Experts - LiveScience, 18 March 2011
Contact
Technology in Motion
Steve Mottram
0113 218 8030
www.technologyinmotion.com
Steve Mottram
0113 218 8030
www.technologyinmotion.com
Contact
Categories