About Evren

Evren was born in July 2010. Shortly after his birth we noticed that he would only turn his head to the right. He had difficulty looking in the other direction. At his first check up we brought up our concerns and the GP noted that he had a stiff neck muscle. We were told it would improve on its own.

His neck muscle did improve. But after many weeks of trying to get him to reposition his head we were still having difficulty and began to notice his head shape changing. At around 4 months we went back to the doctor with our concerns. This was the first time we heard the term Plagiocephaly. We were told that he had developed Plagiocephaly but that it would not affect his development in any way and as he grew his hair would cover the flatness.

We were appauled at this. It was more than just a flat spot on his head we were concerned about. His ears where severely out of alignent. He had noticable facial assymetry. His hair would not cover this. We just didn't think it was good enough.

That's when I started my internet search to find out everything I could about Plagiocephaly and to decide what we could do for Evren. In the end we took him to the London Orthotic Consultancy in Kingston. They where great. They fitted Evren with his helmet just before he turned 6 months old. His intial measurements where 21mm Asymetry (Plagiocephaly) and Cephalic Ratio 97% (Brachycephaly). He adjusted quickly to wearing the helmet. I think it's harder on the parents than it is on the babies really. He wore his helmet for 5 months. His finishing measurements where 5mm Asymetry and Cephalic Ratio 90%. Not perfect, but then who is?

My beautiful baby boy today.

Before and After Scans

How can you help?

Unfortunately despite all the evidence that Plagiocephaly does not always correct itself and is not alway purely a cosmetic problem the NHS are not likely to routinely fund Cranial Bands. I only know of a couple of children that have managed to get NHS funding. With the average cost of private treatment being around £2000 there are many children out there whose parents can simply not afford the cranial bands. Headstart 4 Babies is a great charity that helps families who could not otherwise pay for treatment. Have a look at there section of the Just Giving website and you can read about children who are currently needing treatment and fundraising to help pay for it.

http://www.justgiving.com/h4b

Head Start 4 Babies

Another great website for information and support for parents of Children with Plagiocephaly. Headstart 4 Babies is a registered charity and do offer financial support for families struggling to pay for treatment.

Loki's Plagiocephaly Awareness Facebook Page

This is a great page for support and information created by a mother from Nottingham whose son was treated for Plagiocephaly in 2010.

https://www.facebook.com/pages/Plagiocephaly-flat-head-syndrome-Awareness/166653450037639

Advise from the American Medical Association

The AMA has also issued AMA Policy H-185.967, which declares “that treatment of a minor child's congenital or developmental deformity or disorder due to trauma or malignant disease should be covered by all insurers” and “shall include treatment which, in the opinion of the treating physician, is medically necessary to return the patient to a more normal appearance․” See “Coverage of Children's Deformities, Disfigurement and Congenital Defects,” American Medical Association, AMA Policy H-185.967 .

An artical from the Journal of Cranialfacial Surgery

Babies with Position-Related Head Flattening May Have Higher Rate of Ear Infections

The recommendation to lay babies on their backs to sleep has reduced sudden infant death syndrome (SIDS), but has led to an increased number of infants with a skull deformity called deformational (or positional) plagiocephaly. Now new research suggests that infants with more severe plagiocephaly may have a higher rate of middle ear abnormalities associated with ear infections (otitis media), reports the September issue of The Journal of Craniofacial Surgery. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

Given the potential impact on hearing and other aspects of child development, more research will be needed to clarify the risk of otitis media in infants with deformational plagiocephaly, according to researcher Adam Purzycki, BS, and colleagues of Wake Forest University Medical Center, Winston-Salem, NC.

Results Suggest Possible Increase in Otitis Media with Severe Plagiocephaly

Children with deformational plagiocephaly have flattening of the back of the head, ranging from mild to severe. In recent years, the number of infants with this form of plagiocephaly has increased exponentially as a result of the "Back to Sleep" campaign to prevent SIDS. The growing skull becomes deformed as a result of pressure from lying in the same position. For most affected infants, treatment consists of a helmet or band to gently mold the growing skull into a more normal shape.

The researchers asked the parents of 1,259 children with deformational plagiocephaly about their child's history of ear infections. Almost exactly half of the children had at least one ear infection before one year old-similar to the rate in the normal population. The rate was slightly higher for children with more severe plagiocephaly: 54 percent, compared to 49 percent in those with milder deformity.

In 124 children, the researchers performed a test called a tympanogram, done to measure pressures within the middle ear. Certain patterns of tympanogram results suggest the presence of otitis media.

The results showed "a marked trend" toward a relationship between otitis media-related abnormalities and the severity of plagiocephaly. "The more severe cases (types IV-V) of plagiocephaly had a higher percentage of otitis media than the less severe cases (types I-III)," the researchers write.

Hearing Loss Could Contribute to Developmental Problems

In more severe plagiocephaly, the skull deformity may cause the ear to move forward. Resulting abnormalities of the eustachian tube may cause problems with fluid drainage from the middle ear, promoting infections and otitis media. "The significantly high percentage of tympanogram readings that pointed to otitis media...suggests an overall malfunction of the middle ear drainage function of the eustachian tube in these children," according to Purzycki and colleagues.

There is growing attention to the possibility of long-term complications related to plagiocephaly, with some studies reporting developmental problems such as language disorders and learning disabilities. The new findings raise the possibility that at least some of these problems could be related to hearing loss-a known complication of persistent otitis media in children.

If so, then recognition and appropriate management of otitis media in children with deformational plagiocephaly might help to reduce these long-term developmental concerns. However, the researchers emphasize the need for more research to clarify the link between plagiocephaly and otitis media-including the clinical significance of the abnormal tympanograms.

About The Journal of Craniofacial Surgery

The Journal of Craniofacial Surgery serves as a forum of communication for all those involved in craniofacial and maxillofacial surgery. Coverage ranges from practical aspects of craniofacial surgery to the basic science that underlies surgical practice. Affiliates include 14 major specialty societies around the world, including the American Association of Pediatric Plastic Surgeons, the American Academy of Pediatrics Section of Pediatric Plastic Surgery, the American Society of Craniofacial Surgeons, the American Society of Maxillofacial Surgeons, the Argentine Society of Plastic Surgery Section of Pediatric Plastic Surgery, the Asian Pacific Craniofacial Association, the Association of Military Plastic Surgeons of the U.S., the Brazilian Society of Craniofacial Surgeons, the European Society of Craniofacial Surgery, the International Society of Craniofacial Surgery, the Japanese Society of Craniofacial Surgery, the Korean Society of Craniofacial Surgery, the Thai Cleft and Craniofacial Association, and the World Craniofacial Foundation.

Source: Lippincott Williams & Wilkins

Frenchay Hosptial

You may have heard by now that their is somewhere in the UK where children do receive free treatment on the NHS for Plagiocephaly. Frenchay Hosptial in Bristol. I contacted the Hosptial to verify this information and to ask what criteria they have established for determining if a child should receive NHS treatment. Below are the email responses from the Consultant.

From: Kristian Aquilina

Date: 10 January 2011 17:40:55 GMT

Subject: Treatment for plagiocephaly

Dear Ms Okanay,

Thank you very much for your email. Nitin Patel passed your message on to me as I am one of the paediatric consultants in the department.

I can confirm that we do see children with plagiocephaly on the NHS and we offer them free NHS treatment. The hospital tariff cost for the helmet, which includes a brief anaesthetic to mould the helmet, is £660.

Hope this helps. Please let me know if I there is anything else I can do.

Yours sincerely,

Kristian Aquilina FRCS(SN)

Consultant paediatric neurosurgeon

Department of Neurosurgery

Frenchay Hospital

Bristol.

North Bristol NHS Trust - www.nbt.nhs.uk

Dear Mr Aquilina,

Thank you so much for your reply. I do have one more question if I may, can you let me know what criteria you use to determine if a child should be treated with the helmet / band? I.e. do you use the same system as the private clinics? They told us with regards to asymmetry that it is generally accepted that 0 - 6 mm asymmetry is normal, 6 - 12mm is considered a moderate deformity and anything above 12mm is considered severe. With regards to Cephalic ratio 78% is normal with a standard deviation of 5.5% being normal. Anything over 89% or 2 standard deviations was considered severe. Just wondering if this is in line with your policy for treating babies with plagiocephaly?

From: Kristian Aquilina

Date: 18 January 2011 15:05:42 GMT

Subject: RE: Treatment for plagiocephaly

Dear Ms Okanay,

Apologies for the delay getting back to you.

We do not use any craniometric criteria. We decide whether to offer the helmet or not on the basis of a full discussion with the parents; we discuss their level of concern on their child's cosmetic appearance, their expectations,and the possible complications and results we have had from our helmet. Of course we do get plain skull x-rays and sometimes even a CT scan to make sure that we are not missing a 'real' craniosynostosis.

Does this help?

Thanks and best wishes,

Kristian.

Nice Guidance (or lack of I should say)

This one put a smile on my face. It happened to me several times in my journey to get the NHS to help my son. I was told that NICE did not recommend cranial band treatment and the NHS would not fund it unless it was recommended by NICE. So if a doctor ever says this to you put them straight as this is not true. NICE do not recommend Cranial Band treatment, but they also do not not recommend it. It is simply "out of their remit." Below is the response from NICE.

NICE is an independent organisation responsible for providing national guidance for the NHS in the UK on promoting good health and preventing and treating ill health. Our role is to produce guidance (advice) for the NHS on how to treat health conditions.

We were notified of the topic ‘Moulding helmets / cranial banding for plagiocephaly’ (http://guidance.nice.org.uk/IP/313) for consideration under our interventional procedure programme in February 2055 and following consideration of the topic we decided that it did not fall within the remit of this programme.

It may be useful to provide some background information about our Interventional procedures (IP) programme. IP guidance protects patients' safety and support people in the NHS in the process of introducing new procedures. Many of the procedures that NICE investigates are new, but we also look at more established procedures if there is uncertainty about their safety or how well they work. By providing guidance on how safe procedures are and how well they work, NICE makes it possible for new treatments and tests to be introduced into the NHS in a responsible way.

Whilst our interventional procedures guidance makes recommendations on the safety of a procedure and how well it works, it does not cover whether or not the NHS should fund a procedure. Decisions about funding are taken by local NHS bodies (primary care trusts and hospital trusts) after considering how well the procedure works and whether it represents value for money for the NHS.

As you are aware, in accordance with our published methods guides this particular procedure is not within remit because it is not interventional. To fall within the Programme’s remit, a notified procedure must involve an incision or a puncture or entry into a body cavity, or the use of ionising, electromagnetic or acoustic energy.

It is important to note that just because a treatment or procedure has not been assessed by NICE, does not mean that it should not be made available on the NHS. A lack of guidance from NICE is NOT the same as a recommendation against the use of a treatment. There are many treatments available on the NHS which NICE has not appraised. In the absence of NICE guidance PCT’s are expected to make their own decisions about whether or not to provide this procedure, based on their own assessment of its effectiveness.

The Department of Health has issued good practice guidance for Trusts on managing the introduction of new healthcare interventions, and have stated that “It is not acceptable to cite a lack of NICE guidance as a reason for not providing a treatment”. You can download this good practice guidance document via the following page of the DH website: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_064983 . (This quoted text comes from page 4 of the document).

For further information and advice about your own situation, it would be advisable for you to contact Patient Advice and Liaison Service (PALS). As well as providing information about the NHS and dealing with health related enquiries and concerns, your local PALS office can also advise about the NHS complaints procedure and/or appealing a PCT decision (http://www.pals.nhs.uk ).

I hope this information is helpful. Please do not hesitate to contact me again if you have any further questions.

Kind regards

Janet

Janet Fahie

Communications Executive

National Institute for Health and Clinical Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)845 003 7781 | Fax: 44 (0)845 003 7785

Web: http://nice.org.uk

What the people regulating Doctor and Orthotist in the UK have to say

Well they don't have anything to say specifically about Plagiocephaly. But that's not their job. What they are responsible for is making sure that the Doctors and Orthotist providing these treatment are up to date the information and treatments they are providing and do not provide misleading information. And I think this is significant because if Cranial Banding where a scam to pry on the fears of new parents by making unfounded statements that their babies could be faced with a permanent deformity if they are not treated then the GMC and HPC would have acted to stop it.

If you feel like having a read below are the responses from the GMC and HPC regarding their role in regulating Doctor's and Orthotists.

From the GMC

The General Medical Council is the independent regulator for doctors in the UK. Our statutory purpose is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.

The law gives us four main functions under the Medical Act 1983:

· keeping up-to-date registers of qualified doctors

· fostering good medical practice

· promoting high standards of medical education and training

· dealing firmly and fairly with doctors whose fitness to practise is in doubt.

Doctors who wish to practice medicine in the UK must be registered with the GMC and, in most cases, hold a licence to practise. We give guidance to doctors on the principles of good practice and the standards we expect them to meet. Serious or persistent failure to follow the guidance will put a doctor_s registration at risk.

Private healthcare providers must also be registered with the Care Quality Commission (www.cqc.org.uk), the independent regulator of health and social care in the UK.

We are not in a position to advise doctors about the suitability or otherwise of particular treatments as our remit does not extend to collecting, analysing or disseminating clinical information. We do not therefore, produce clinical guidance.

However, we expect doctors to follow the advice in Good Medical Practice, our core guidance for doctors, which makes clear that when providing care, doctors must prescribe drugs or treatment only when they have adequate knowledge of the patient_s health, and are satisfied that the drugs or treatment serve the patient_s needs and provide effective treatments based on the best available evidence (paragraph 3(b) and (c)).

We also advise doctors that they must keep their knowledge and skills up to date throughout their working lives and that they should be familiar with relevant guidelines and developments that affect their work. This would include keeping up to date with evidence about the effectiveness of relevant medical treatments. Information about the effectiveness of medical treatments, and the risks and benefits attaching to them, is available from a wide range of sources including government health departments and regulatory agencies, the medical royal colleges, independent organisations such as the National Institute for Health and Clinical Excellence (NICE), medical research journals and other publications.

Doctors must also obtain patient_s consent (or in the case of young children, usually the consent of a parent or parents) before providing any medical treatment. When seeking consent, doctors must give patients the information they want or need so that they can make an informed decision about whether to consent. In our guidance booklet, Consent: patients and doctors making decisions together we set out the information that patients are likely to want or need to know. This includes information about:

· The purpose of any proposed investigation or treatment and what it will involve

· The potential benefits, risks and burdens, and the likelihood of success, for each option

· Whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit

· Their right to seek a second opinion.

There are times when there may be uncertainty about the effectiveness of particular treatments or whether a particular treatment is better than another. In the absence of any definite research or audit evidence, doctors must use their clinical judgement, and the best available evidence, to make decisions about whether the treatment is appropriate for a particular patient.

While we do not require doctors to only provide evidence based treatments to patients, they must be satisfied that any treatment that they provide is in the patient_s best interests. This will generally mean that any known risks of the treatment are outweighed by the potential benefits to the patient. Doctors must always be prepared to explain and justify their actions or decisions including their decisions about treatment for patients.

In addition, Good Medical Practice also makes clear that doctors must not make unjustifiable claims about the quality or outcomes of their services in any information they provide to treatments and it must not offer guarantees of cures, nor exploit patient_s vulnerability or lack of medical knowledge. They must not put pressure on patients to use a service, for example by arousing ill-founded fears for their future health (paragraph 60-62). Nor must they put pressure on patients to accept private treatment (paragraph 72(e)).

I hope that this is helpful in explaining our role and the guidance we expect doctors to follow.

Kind Regards

Suzanne

Suzanne Wood 
Policy Adviser
Standards & Ethics Section

The HPC regulates orthotists within the UK. Only

someone who is registered with us can practice as an orthotist or use the

protected title 'orthotist'. We set standards which our registrants have to

meet, including the standards of conduct, performance and ethics (SCPE).

One of the standards within the SCPE says:

"Any advertising you do in relation to your professional activities must be

accurate. Advertisements must not be misleading, false, unfair or

exaggerated. In particular, you should not claim your personal skills,

equipment or facilities are better than anyone else’s, unless you can prove

this is true.

If you are involved in advertising or promoting any product or service, you

must make sure that you use your knowledge, skills and experience in an

accurate and responsible way. You must not make or support unjustifiable

statements relating to particular products. Any potential financial reward

should not play a part in the advice or recommendations of products and

services you give."

The standards of conduct, performance, and ethics can be found here on our

website:

http://www.hpc-uk.org/aboutregistration/standards/standardsofconductperformanceandethics/

.

Anyone registered as an orthotist would have to meet this standard and we

could take action against them if they were not meeting the standard. So,

if an orthotist was advertising a particular treatment they should make

sure that their advertising was not misleading, false, unfair or

exaggerated. Although there is no specific statement about advertising

which went against established guidance, such as that from the Department

of Health, the general principles within the standard could still be

applied to this situation. The orthotist advertising the treatment would

need to demonstrate that the treatment was appropriate for the conditions

it was being advertised for. In addition, they would also need to

demonstrate that the treatment was appropriate for any particular patient

that they offered it to. If you have concerns that the orthotist is making

false advertising claims, you can raise those concerns with our fitness to

practise department: http://www.hpc-uk.org/complaints/.

Although we regulate individual orthotists, we do not regulate the

provision of services, in this case, the companies themselves. If you have

concerns about false or misleading advertising being undertaken by the

companies, you can contact the Advertising Standards Authority:

http://www.asa.org.uk/.

I hope that this answers your question but if you need anything further

please get in touch.

Best wishes,

Charlotte Urwin

Policy Manager

Policy & Standards department

Health Professions Council

Court Cases in the US in which the Courts ruled that the treatment for Plagiocephaly was not a cosmetic only treatment

I'm American. For those unfamiliar the USA Healthcare system is mostly private. I found these court case interesting because in order for the insurance company to be ordered to pay for the treatment the Plaintiff's and thier doctors had to prove the treatment was medically necessary and not strictly a cosmetic procedure.

It was one of the issues I was most concerned about. I know alot of people frown at parents putting helmets on their babies thinking we are being vain or petty about how our child looks. I won't lie and say that his appreance didn't concern me. But I was also very worried about the possible side affects. Many people where discussing possible links to chronic ear infections, headaches and development delays. This concerned me way beyond the possible affects of bullying should his head shape not recover on its own.

Reading these documents helped me in reaching my decision to go ahead with the cranial band treatment.

SUZANNE BYNUM, Plaintiff-Appellee,

v.

CIGNA HEALTHCARE OF NORTH CAROLINA, INCORPORATED,

Defendant-Appellant.

http://www.harp.org/bynum.htm

JAMES 14 v. STATE OF SOUTH CAROLINA EMPLOYEE INSURANCE PROGRAM

http://caselaw.findlaw.com/sc-court-of-appeals/1211506.html

Link to Plagiocephaly Advice from Great Ormond Street

Great Ormond Street Hospital publish the below link for advice for parents of children with Plagiocephaly.

I find it interesting that they state if helmet treatment is to be effective it "would seem sensible to start using them when the head is still ‘plastic’ enough to have the natural correction process encouraged by restricting growth in the ‘bulgy’ parts of the head while encouraging growth in the flatter areas by leaving them free - preferably before six months".

And also note that in this advise sheet, though they try to down play it, they do state that in severe cases a degree of flattening usually remains.

My son was referred to GOSH by his paediatrician for severe plagiocephaly in 2010. GOSH sent a letter refusing to offer him an appointment.

http://www.gosh.nhs.uk/medical-conditions/search-for-medical-conditions/plagiocephaly/plagiocephaly-information/

Response from NHS Bristol regarding funding for Plagiocephaly Treatment

FOI 1011 367

Summary Issue – Plagiocephaly

Question

I am aware that Bristol PCT is providing treatment for children with

Plagiocephaly. I know that the helmets are provided by Frenchay

Hospital. As I am sure you are aware most PCT's in the UK do not

provide treatment on the NHS for plagiocephaly. I am wondering if you

could advise why Bristol have decided the treatment should be offered

to babies in your area?

Response

This is not a Bristol only service

It is a regional service commissioned by the South West

Specialised Commissioning Group for the South West

and provided by North Bristol NHS Trust at Frenchay

Hospital. The cost of the helmet is included in the total

procedure cost and there is no additional cost to the

commissioner.

The moulding cap treatment at Frenchay was set up

originally for post-operative treatment for babies having

cranial remodelling procedures for delayed diagnosis -

synostosis, but has been used for many years to treat

babies with severe plagiocephaly that has not

responded to standard postural measures. North Bristol

NHS Trust believe sufficient evidence exists to support

the technique in reducing the risk of long term cranial

deformity and avoiding a few of them having big

craniofacial remodelling operations

The information provided in this response is accurate as of 28 March 2011

Kat Tucker
Complaints & FOI Manager
NHS Bristol
0117 900 2494

Link to information about Artificial Cranial Deformation

This is one practice that I found particulary interesting while I was doing research on Plagiocephaly. I found it interesting that with this practice which has been followed by some cultures for 1000's of years after 6 months of moulding the resulting deformation was permanent. How can it be said that Plagiocephaly will spontaneously correct as the child grows when the deformations are clearly permanent in other individuals? I think that it is more likely that a the deformation is less noticable for a child with Plagiocephaly as they grow and "the hair covers it" especially if the child only had mild to moderate Plagiocephaly to begin with. I do not believe it simply corrects itself. And in the case of children with a severe deformity I feel it is negligent to promise parents that it will improve.

http://en.wikipedia.org/wiki/Artificial_cranial_deformation