NICE correspondence


CONTENTS OF BUNDLE A

NICE materials

Head injury guideline
The head injury guideline CG56 and its appendices are both very lengthy documents, available on this link http://guidance.nice.org.uk/CG56/Guidance . I have attached only the sections that are relevant to my complaint. These are:
Document 1: Chapter 1 – Background and Scope
Document 2: Chapter 8 – Discharge and follow up
Document 3: Chapter 9 – Admission and observation
Document 4: Appendix A – Remit and Scope
Document 5: Appendix E – Suggested written discharge advice card for patients aged over 12 years who have sustained a head injury
Document 6: Appendix F – Suggested written discharge advice card for carers of children who have sustained a head injury
Document 7: Appendix G – Suggested written discharge advice card for carers of adults
Other relevant documents

Document 8: NICE Audit support, head injury (December 2007)
Document 9: NICE Guidelines Manual, Chapter 14, Updating clinical guidelines and correcting errors
Document 10: NICE Social Value Judgements, Chapter 3 Fundamental operating principles, 3.2 Procedural principles.
Document 11: ‘Changes I would like to see to CG56’
Document 12: letter from Professor Chris Thompson to Mrs Joanna Lane dated 17 July 2009
Studies

[1] Hypothalamopituitary dysfunction following traumatic brain injury and aneurismal subarachnoid hemorrhage: a systematic review, Schneider HJ et al, JAMA 2007
http://www.ncbi.nlm.nih.gov/pubmed/17895459

[2] Hypopituitarism and brain injury: recent advances in screening and management, Pickel J et al, F1000 Medicine Reports 2009, http://webcache.googleusercontent.com/search?q=cache:1LOB5-_Ni-0J:f1000medicine.com/reports/10.34

[3] Prevalence of anterior pituitary dysfunction in patients following traumatic brain injury in a German multi-centre screening program, Berg C, Experimental and Clinical Endocrinology and Diabetes Feb 2010. http://christie.openrepository.com/christie/handle/10541/109060

[4] Should anterior pituitary function be tested during follow-up of all patients presenting at the emergency department because of traumatic brain injury? Van der Eerden K et al, European Journal of Endocrinology, 2010 http://www.eje-online.org/cgi/content/abstract/162/1/19

[5] Hypopituitarism following traumatic brain injury: the prevalence is affected by the use of different dynamic tests and different normal values, Kokshoorn N et al, European Journal of Endocrinology, 2010 http://www.eje-online.org/cgi/content/short/EJE-09-0601v1


CONTENTS OF BUNDLE B
Correspondence between NICE and Ms Joanna Lane numbered 1-34

Date Document Page No

26.11.08 1: JL to Natalie Whelan 2
26.11.08 2: Natalie Whelan to JL 4
28.11.08 3: Natalie Whelan to JL 5
18.12.08 4: JL to Natalie Whelan 7
29.12.08 5: Natalie Whelan to JL 8
20.02.09 6: JL to Natalie Whelan 9
26.02.09 7: JL to Andrew Dillon 10
27.02.09 8: Natalie Whelan to JL 12
06.03.09 9. JL to Natalie Whelan 14
24.03.09 10: Teresa Birch to JL 15
24.03.09 11: JL to Teresa Birch 16
26.03.09 12a: JL to Teresa Birch 17
26.03.09 12b: JL to Teresa Birch 18
27.03.09 13: JL to Teresa Birch 19
15.04.09 14: Andrew Dillon to JL Ap 1
24.04.09 15: JL to Andrew Dillon 21
27.05.09 16: JL to Andrew Dillon 22
11.06.09 17: Fergus Macbeth to JL Ap 2
29.06.09 17a: Teresa Birch to JL 24
01.07.09 18: JL to Teresa Birch 25
19.07.09 19A: JL to Natalie Whelan 26
19.07.09 19b: JL summary FOI request 27
19.07.09 19c JL ‘omission causes harm to patients’ 29
17.07.09 20: Chris Thompson to JL Ap 3
30.07.09 21: JL to Fergus Macbeth 32
17.08.09 22a: Alana Christopher to JL 41
17.08.09 22b :FOI Docs 1,2,3,7,8,9,10,11,12,13,20,21,22,25 Aps 4-17
10.09.09 23: JL to Alana Christopher 48
09.10.09 24: Alana Christopher to JL 54
23.10.09 25: JL to Alana Christopher 56
30.10.09 26: JL to Andrew Dillon 58
30.11.09 27: Andrew Dillon to JL 60
07.01.10 28: JL to Andrew Dillon 62
11.01.10 29: Andrew Dillon to JL 63
19.08.10 30: Moya Alcock to JL 64
01.07.10 31: JL to Jane Cowl 65
19.08.10 32: Teresa Birch to JL 67
22.07.10 33: JL to Teresa Birch 68
19.08.10 34: Moya Alcock to JL 69

DOCUMENT 1

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 26 November 2008 13:59
To: Natalie Whelan
Subject: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

Thank you for listening to me just now!

I have patched in below an example of the recent research on hypopituitarism as a consequence of brain injury.You will see that 28% to 69% of brain injury survivors have pituitary damage.

As I was explaining to you, we think it's likely that our son's impotence (discovered by us after his death) was related to a severe head injury he had when he was seven. He would not consult a doctor about his ED, according to his ex-girlfriend, but he did seek help for his depression, and saw two GPs, a psychiatrist and two counsellors. None of them was aware of the research, so his history of TBI rang no bells. But if it had, they would have assessed his pituitary function and we understand he could have been treated successfully with testosterone patches.

We think it's vital to update your Guideline on Head Injury (CG56) to reflect this. In particular Appendices E, F and G, which give sample discharge advice cards, should include a warning that pituitary problems may become apparent years after the injury, in adolescence. And if it's impotence, the patient won't necessarily seek help.

I also think advice relating to depression and erectile dysfunction should point out that head injury can be a cause.

If you would like me to send you more research on the topic I'll be very glad to.

With best wishes

Joanna Lane

The effects of head trauma on hypothalamic-pituitary function in children and adolescents.
Endocrinology and metabolism
Current Opinion in Pediatrics. 19(4):465-470, August 2007.
Einaudi, Silvia; Bondone, Claudia
Abstract:
Purpose of review: Endocrine dysfunctions have been increasingly recognized following traumatic brain injury. Ever more numerous studies on acute head-injured adults have also raised concern about this risk in children and adolescents who have experienced head injury. The current review of the pediatric literature summarizes recent findings on acute-phase dysfunction and traumatic brain injury-associated hypopituitarism.
Recent findings: The pathophysiologic mechanisms underlying acute-phase hyponatremic and hypernatremic disorders have been elucidated. Prospective studies on traumatic brain injury-associated hypopituitarism in pediatric patients are ongoing and preliminary data are available.
Summary: Traumatic brain injury, a 'silent epidemic' (my emboldening) that carries a considerable burden of disabilities, leads to a variety of endocrine dysfunctions in 28-69% of adult acute head-injured patients. In the acute posttraumatic phase, adrenal insufficiency and electrolyte disorders are critical conditions. Neurosurgical patients, particularly those prone to neurological damage, require prompt diagnosis. Hypopituitarism may be diagnosed months or years after a traumatic brain injury event. Since growth hormone and gonadotropin secretion are most frequently compromised, careful follow-up of growth and pubertal development is mandatory in children hospitalized for traumatic brain injury.
(C) 2007 Lippincott Williams & Wilkins, Inc.

 

DOCUMENT 2

----- Original Message -----
From: Natalie Whelan
To: Joanna Lane
Sent: Wednesday, November 26, 2008 2:30 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

I just wanted to let you know that I have received your email – I will respond as soon as possible.

Regards,
Natalie

Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785

DOCUMENT 3

From: Natalie Whelan
To: Joanna Lane
Sent: Friday, November 28, 2008 3:26 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

Thank you for your comments and suggestions regarding the NICE Guideline on Head Injury (CG56) and damage pituitary function. I can appreciate that this is a very important issue for you, so I hope the following information can help provide you with an understanding of how NICE guidelines are amended after publication.

Following the publication of a clinical guideline, NICE and the NCC will not normally actively seek new evidence on an ongoing basis. However, the National Collaborating Centre (NCC) involved in producing the original guideline can ask NICE to review guidance earlier.

The guidance on the ‘Triage, assessment, investigation and early management of head injury in infants, children and adults’ was published in September 2007. There is no review date currently set for this guidance, although, usually, the NCC will undertake searches for new evidence and will make its recommendations about the need for and extent of an update, two years after the publication date. At this point, the quality of the new evidence will be considered, and it will be decided whether the guideline requires a complete, partial or no update. Four years after publication, the review process will be repeated.

In exceptional circumstances, significant new evidence may emerge that may necessitate an unscheduled partial update of a guideline. This might be one single piece of evidence, an accumulation of relevant pieces of evidence, or other published NICE guidance sufficient to make it likely that one or more recommendations in the guideline need changing in an important way. Examples of such evidence include randomised trial data, new diagnostic tests, changes in licensing or warnings issued by licensing agencies, or major changes in costs.

I have made your email available to the National Collaborating Centre for Acute Care, the NCC involved in producing the Head Injury guideline.

Please note that NICE have not yet been asked by the Department of Health to produce guidance on Erectile Dysfunction. However, the guidance on Depression is due to be reviewed in December 2008. Further details about this review (when available) will be listed via the following page: http://www.nice.org.uk/CG23

When a guideline is being reviewed, during the consultation period you will be able to submit your comments on the scope/recommendations, or you could do so via one of it’s registered stakeholder organisations (such as a patient/carer organisation – the names of stakeholder organisations will be listed on the particular guidance webpage).

I hope this information is helpful for you. Thank you for getting in touch with NICE.

Kind regards,
Natalie


Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785

DOCUMENT 4

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 18 December 2008 11:11
To: Natalie Whelan
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

Thank you so much for being so helpful on the phone back in November, and for passing on my email to the NCC involved in producing the Head Injury guideline.

Would it be possible for you now to find out if they do intend, as a result of my email, to do an unscheduled partial update? As you can see from the attached research, suicidal depression is far higher among TBI-survivors than the general population.

It seems so important to update the sample discharge letter, which makes no mention of the at least 25% risk of hypopituitarism. This would only be a matter of inserting the same few words into each of the Appendices E, F and G. If our son's letter of discharge had contained such a warning, it would have saved his life.

I hope you have a good Christmas.

Best wishes

Joanna



DOCUMENT 5

(From Natalie Whelan, Enquiry Handling, sent 29 December 2008 11.47)

Dear Joanna

I’ve looked into this for you and have been informed by the NCC that there are no plans to conduct an unscheduled review. However, this study will be kept on file and will be considered for inclusion when the guideline is next reviewed.

Kind regards,
Natalie


Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785

DOCUMENT 6

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 20 February 2009 16:03
To: Natalie Whelan
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

I hope you're well.

I thought you might be interested in reading an article by me published in today's Guardian.
http://www.guardian.co.uk/lifeandstyle/2009/feb/20/1

I have been thinking more about the need to update CG56 on head injury. In your email you explained that NICE updates fully every six years - 2 yrs after the guideline has come out NICE reviews the need to update, and then spends 4 years on the update itself. And you then said that as CG56 had been updated in 2007, nothing would happen for several years.

However when I recently revisited CG56 I noticed that the 2007 update is a partial update, which changes the picture completely. The last full update was in 2003 so CG56 is well due for revision.

What I would be very grateful if you would do for me, is find out exactly who it is who makes the decision on whether an update is necessary or not. I've rung the NCC who say NICE decides, and I've rung NICE and they say the NCC decides, and I now have emailed the Dept of Health who have said 'they aim to reply within 20 working days.'

But I feel you are sympathetic, and maybe with a few well-placed questions you could tell me who to approach, which is half the battle!

Thanks for helping me last time, and I hope you find the article interesting.

With all good wishes

Joanna



DOCUMENT 7

28 Southwood Avenue
Coulsdon, Surrey
CR5 2DT

Mr Andrew Dillon CBE, Chief Executive Officer
NICE
Mid City Place
71 High Holborn
London WC1V 6NA

26 February 2009

Dear Mr Dillon

Updating CG56 Head Injury Guideline

I am writing to ask if CG56 can be updated to include recent research on ‘hypopituitarism after traumatic brain injury’. Googling this topic currently brings up 44,300 links to a large body of peer-reviewed papers in the main medical journals.

The update is urgently needed because this condition affects one in five (conservatively) of moderate to severe head injury survivors, of which there are 21,000 a year in the UK. It can cause loss of libido, erectile dysfunction, amenorrhea, infertility and severely diminished quality of life. Many studies stress how under-diagnosed it is and estimate that most cases are never diagnosed at all.

Our particular reason for writing is that our 31-year-old son committed suicide last year, and we discovered afterwards that he was impotent. It is likely that this, and his depression, were caused by a severe head injury he had when he was seven.

Whether or not this is so, 1000s of head-injured people have been discharged from hospital in past decades without being screened for an unpleasant, sometimes life-threatening condition which they have a 20% chance of suffering from. This is terrible. It is hard to believe that research which has been coming out in such quantities since the year 2000 is still not reflected in hospital procedure.

Your organisation has told me that CG56 was updated in 2007 so there are no plans to update again. However I see that the 2007 version was a partial update covering only a few areas. The last full version came out in 2003 – so it is overdue for revision.

Please will you give this matter priority? I have written articles for Pulse, Mental Health Today, Therapy Today and the Guardian, and have had one accepted by the Telegraph. If you wish to read my Guardian article (Friday 20 Feb) the link is
http://www.guardian.co.uk/lifeandstyle/2009/feb/20/1

Yours sincerely



Joanna Lane




DOCUMENT 8

----- Original Message -----
From: Natalie Whelan
To: Joanna Lane
Sent: Friday, February 27, 2009 3:37 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

I appreciate you sending me the link to the Guardian article, thank you.

In your email you refer to the NICE updating clinical guidelines fully every six years, however, this isn’t correct. The Clinical Guidelines manual was updated at the start of this year. So instead of considering a review at 2 and 4 years, the procedure is to now consider an update every 3 years (at which point it may be decided that a partial or full update is required, or no update etc). The Head Injury update was published in Sept 2007 so the next consideration of an update will be next year (Sept 2010). Apologies for any confusion caused by my earlier response.

I hope the following points help to clarify the procedure in relation to updating clinical guidelines:

 NICE and the NCC will not actively seek new evidence on an ongoing basis, beyond collating post-publication comments, unless it has been identified in the guideline that important new information is likely to emerge before the 3-year scheduled review. In such instances, the NCC is responsible for alerting NICE to the new evidence and advising on the need for an exceptional update or amendment
 The NCC advises the Centre for Clinical Practice (CCP) at NICE about the need for, and extent of, an update 3 years after publication of a clinical guideline.
You can read more about this in Chapter 14 of the new Guidelines Manual, available at the following link: http://www.niceorg.uk/aboutnice/howwework/developingniceclinicalguidelines/clinicalguidelinedevelopmen tmethods/GuidelinesManual2009.jsp?domedia=1&mid=631D9427-19B9-E0B5-D482D5F402778A25
I have spoken to my colleagues at the NCC, who have explained that the research you had previously provided us with has been passed to the chair of the Guideline Development Group, and we await his comment.
I’m sorry it’s not possible to provide you with further information at this stage, but I shall be in contact again when I have an update for you.
Kind regards,
Natalie


Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785





DOCUMENT 9

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 06 March 2009 15:53
To: Natalie Whelan
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

Thank you so much for all your trouble. The reference to Chapter 14 was helpful.

I do feel though that you've not quite answered my point that the 2007 update was only partial. Can a partial update have the status of a full one, and absolve NICE from doing a full update at the right interval of years from the last full update? This seems like saying that because you replaced your car tyres in August, you don't have to do anything when your annual service comes round in October!

With my best wishes, and thanks again for your help.

Joanna





DOCUMENT 10
----- Original Message -----
From: NICE Mail
To: joannalane@blueyonder.co.uk
Sent: Tuesday, March 24, 2009 4:09 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

Thank you for your further email and I’m sorry for the delay in responding. Natalie has asked me to respond to your enquiry to provide some further clarification about our process for updating guidelines.

A partial update is still regarded as full and final NICE guidance and has the same status within the NHS as the original guideline. A partial update of the guideline was conducted in 2007 as only evidence relating to specific areas was identified as being significant enough to change part of the recommendations.

If you think about this in relation to a car‘s annual service When you take a car in, they would still perform a check on the tyres (even though they were replaced recently) but make a decision that they were still good for the road and didn’t actually need replacing at that time.

I understand that you have also sent a letter directly to Andrew Dillon about updating the guideline. Andrew has asked me to let you know that he will be replying to your letter soon.

Kind regards

Teresa

TB
Communications Manager (Enquiry Handling)
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


DOCUMENT 11

From Joanna Lane to Teresa Birch, sent 24 March 2009 18:24

Dear Teresa

All updates are partial, in the sense that they contain part of the old material. If they didn't they wouldn't be updates, they would be completely new documents.

The 2007 update was called 'partial' because only evidence relating to specific areas was looked at. If the NCC had been aware of the substantial body of research showing that one in four head injuries results in consequences as serious as impotence, infertility and suicidal depression, I am quite sure they would have regarded it as 'significant enough to change part of the recommendations.' But they didn't see it, and they didn't put it in.

They called it 'partial' to cover themselves from this kind of accusation. But I don't think they can have it both ways - 'partial' to cover themselves if people notice something that's been left out, but 'full' when they want to excuse themselves from doing a proper update at the correct time.

I hope I'm not putting this too strongly. You may be aware that our son committed suicide after suffering impotence and depression following a long-ago brain injury, so I can't help feeling an acute urgency to get this guideline updated properly.

My approach now to this issue will be that I shall withdraw from the argument, but hopefully put it into the hands of people who have more clout than I have. I am pre-recording an interview with Woman's Hour tomorrow when, if all goes well I believe Professor Chris Thompson, an eminent endocrinologist who has won the Servier Award in 2007 for his research into pituitary dysfunction after brain injury, will give his opinion on the steps that should be taken. I'll let you know when the programme is scheduled to go on air.

I am pleased to hear that Andrew Dillon will be replying to my letter, and I'd like to thank you for taking the trouble to reply to my email to Natalie.

With all good wishes

Joanna


DOCUMENT 12A

Sent by Joanna Lane to Teresa Birch, 26 March 2009, 09:28


Dear Teresa

Further to my last email I thought I would let you know that the Woman's Hour feature on head injury and pituitary dysfunction is being broadcast this morning. Unfortunately Professor Thompson wasn't able to take part, but Dr Tara Kearney of Salford Royal Hospital gave what seemed to me a comprehensive and clear account of the condition, and you might want to listen to it (it will be available on podcast on the BBC website afterwards).

With my best regards

Joanna




DOCUMENT 12B


Sent by Joanna Lane to Teresa Birch 26 March 2009 09:36

Dear Teresa

I should have mentioned that the interview with me is under the pseudonym Caroline Churchill.

Joanna


DOCUMENT 13

----- Original Message -----
From: Joanna Lane
To: NICE Mail
Sent: Friday, March 27, 2009 4:49 PM
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Teresa

Further to my last email, before I finally withdraw from the debate as I said I would, it would be a great help to me if you would define exactly what is meant by a full update of a guideline, and what differentiates it from a partial one.

We're away all next week so there is no hurry.

Once again, thank you for your help!

Kind regards

Joanna


DOCUMENT 14

This letter from Mr Andrew Dillon dated 15 April 2009 is a pdf document and given as Appendix 1.


DOCUMENT 15

28 Southwood Avenue
Coulsdon
CR5 2DT
Mr Andrew Dillon
Chief Executive
NICE
MidCity Place
71 High Holborn
London WC1V 6NA
Friday 24 April 2009
Dear Andrew Dillon

Updating CG56 Head Injury Guidelines

Thank you for explaining that partial updates have the same status as full ones. I accept that I have to abandon that line of argument. However, may I now try a different approach?

You say of the 2007 update that “only evidence relating to specific areas was identified as being significant enough to change part of the recommendations.” This implies that all the evidence was looked at, and the endocrine evidence was considered not “significant enough.” But a condition that occurs in 25% of cases and can cause death (see first bullet point below), impotence, infertility and suicidal depression is certainly not insignificant. It would surely be more accurate to say that because the 2007 guideline development group did not contain an endocrinologist, the abundant endocrine evidence was missed. In other words, it was an error.

Your Guidelines Manual says (14.6) that the identification of errors which may result in harm to patients may trigger an exceptional update.

CG56’s omission of all reference to hypopituitarism is exactly this – an error which may result in harm to patients – for the following reasons.
 A deficiency of ACTH is life-threatening in the acute stage.
 Patients must be screened for hypopituitarism at 3 months and a year after the injury if this notoriously under-diagnosed condition is to be picked up.
 CG56’s sample discharge letter does not warn that pituitary dysfunction may occur, possibly many years after the injury. So patients – and their parents – will not know of the risk of impotence, infertility and depression. This in itself may cause death, as we believe it did with our son.

I hope you will agree there is a case for an exceptional update of CG56.

Yours sincerely




Joanna Lane

 

DOCUMENT 16
28 Southwood Avenue
Coulsdon
CR5 2DT
Mr Andrew Dillon
Chief Executive
NICE
MidCity Place
71 High Holborn
London WC1V 6NA

27 May 2009
Dear Andrew Dillon

Updating CG56 Head Injury Guidelines

You may remember I wrote to you on 24 April asking whether you would consider an exceptional update to CG56 on the grounds that the present omission of reference to hypopituitarism is an error which may result in harm to patients.

If you have decided not to take this any further I shall understand, but it would be helpful if you could let me know one way or the other.

With many thanks.

Yours sincerely




Joanna Lane


DOCUMENT 17

This letter from Dr Fergus Macbeth dated 11 June 2009 is a pdf document and is given as Appendix 2.


DOCUMENT 17a

From: “NICE” nice@org.uk
To: joannalane@blueyonder.co.uk
Sent: 29 June 2009 12:40
Subject: RE: CG56

Dear Joanna

Dr. Fergus Macbeth has asked me to respond to your email on his behalf.

Unfortunately we are not at liberty to release the name of the author of the as yet unpublished research that Dr. Macbeth refers to, nor are we able to comment on the precise incidence of the condition in the report. As Dr. Macbeth stated in his letter, he believes that this research will be submitted for publication in due course.

Our discussion so far with experts has shown that there seems to be a difference in opinion about this issue and limited but contradictory evidence, but we are not able to change recommendations unless they are clearly supported by good quality evidence.

Because of your personal situation and interest in this subject one of the ways we feel you could help take this important issue forward is by helping to influence high quality research in this area. For more information bout research within the NHS, you may find the following website useful:

http://www.nihr.ac.uk/Pages/default.aspx

Dr. Macbeth has thoroughly investigated the points you have raised and confirmed that an immediate update is not justified. As we’ve already stated, when the guideline is updated we will ensure that this issue is addressed.

Unfortunately at this stage we are unable to help you any further.

Kind regards

Teresa

Teresa Birch
Communications Manager (Enquiry Handling)
National Institute for Health and Clinical Excellence



DOCUMENT 18
28 Southwood Avenue
Coulsdon
CR5 2DT

Ms Teresa Birch
Communications Manager (Enquiry Handling)
NICE
Level 1A City Tower Piccadilly Plaza
Manchester M1 4BD

1 July 2008


Dear Teresa

I thought I should formalise my request, under the Freedom of Information Act, that NICE disclose everything they have regarding the process they have gone through on the issue of doing an exceptional update on CG56.

I appreciate that you have told me that the information on hypopituitarism will be included when the guideline is updated, and this is good news.

However, last time the interval between beginning the update process on CG56 and the final publication was two years and a month. On this reckoning it will be October 2012 before the next update is produced.

On the basis that 150,000 head injuries occur annually, and 10%* of them will suffer pituitary dysfunction, that means around 45,000 people will have been needlessly left at risk in the 3 years between December 2008 when I first alerted NICE to their omission and the date they eventually remedy it. Interestingly only about 2,000 cases of hypopituitarism from all causes were diagnosed last year.

I consider this decision needs to be justified by NICE with the transparency that is one of its fundamental principles.

Yours sincerely




Joanna Lane

*My estimate is based on the most recent published research. I am open to persuasion that it is wrong, but would need to see the evidence.


DOCUMENT 19A

28 Southwood Avenue
Coulsdon
CR5 2DT

Ms Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza
MANCHESTER M1 4BD

19 July 2009

Dear Natalie

As I said in my email to you of 19 July, I am enclosing two documents:

1) A summary of my Freedom of Information request 22123
2) A document arguing that NICE have a duty under their own rules to do an immediate update of CG56.

I look forward to hearing from you.

With many thanks

Yours sincerely





Joanna Lane


DOCUMENT 19B

SUMMARY OF FREEDOM OF INFORMATION REQUEST 22123

On 11 June Dr Fergus Macbeth wrote to me declining to do an immediate update on CG56 on the grounds that recent unpublished research had shown that there was a very much lower incidence of TBI-induced hypopituitarism than previously seen. He said “It’s important for us to target our resources in a way that gives the most benefit to the largest number of people.” I interpret this to mean that he had calculated the cost of an immediate update of CG56, and of the consequent diagnosis and treatment of patients with PTHP, and decided that this amount of money could benefit a larger number of people if spent in a different way.

In your publication SOCIAL VALUE JUDGEMENTS the following paragraph occurs under the heading Regulation:

It is particularly important for NICE to be ‘accountable for its reasonableness’ because it provides advice to the NHS. The NHS is funded from general taxation, and it is right that UK citizens have the opportunity to be involved in the decisions about how the NHS’s limited resources should be allocated.

I would like to see Dr Ferguson’s cost-benefit analysis
I am emboldened by the words quoted above to ask, as a tax-paying UK citizen, to see the cost-benefit analysis whereby Dr Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism so that it would not be published until (as we estimate) October 2012. During the delay I estimate that between 30,000 and 45,000 head injury patients will remain undiagnosed of a condition that seriously affects their quality of life. Many may suffer broken marriages and relationships as a result. Some may commit suicide.

Incidentally I understand that in general interventions with an ICER of less than £20,000 per QALY gained are considered to be cost-effective and I would imagine this would apply here.

I would like to see all documents generated by my April letter to Mr Dillon
I would like to see all the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June. This would include any notes resulting from his telephone conversation with the unnamed endocrinologist.

A question about your procedural principles
I understand from the section on ‘Procedural principles’ in Social Value Judgements that NICE would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. I would like to know what these exceptional circumstances are. I would also ask under what FOI exemption you are withholding this unpublished research from me.

On what grounds can NICE justify not warning patients of the risks they face?
Furthermore (with reference to the principle of ‘respect for autonomy’ described in the same document) I would like to know on what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time. If individuals have a right ‘to make informed choices about healthcare . . .and health protection’ it is crucial that they are given information about the risks they face.

I understand that I can expect to wait for 20 working days before I receive an answer to this FOI request.

Thank you very much for your help on this matter.
19 July 2009
Joanna Lane


DOCUMENT 19C

The omission to mention hypopituitarism in CG56 was an error which may result in harm to patients

May I first draw attention to the title of CG56, Triage, assessment, investigation and early management of head injury in infants, children and adults noting in particular the words ‘assessment’ and ‘investigation.’ I would then like to review the process whereby the guideline was developed.

1. The scope clearly envisaged complications such as hypopituitarism
The original Scope document for CG56 (unchanged apparently since 2001) has a paragraph on ‘Clinical Need and Practice’ which contains the statement:

Most [head injury] patients recover without specific or specialist intervention but in others, persistent disability or even death results from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment. Much of the controversy and uncertainty in the early care of head injured patients is focused upon how these patients are best managed.

I need not labour the point that pituitary dysfunction is a complication that can result in persistent disability or even death. Dr Macbeth’s own words in his letter to me were “I am not denying the seriousness of this condition and the scope for a disastrous outcome if not recognised.”

2. The scope intended that the guideline should ensure such complications were detected
The scope document says ‘The guideline will not address the rehabilitation or longterm care of patients with head injury but the guideline will provide criteria for the early identification of patients who would benefit from rehabilitation. It continues that the guideline will include

information for patients and carers, and advice to primary care on the management of patients who re-present with suspicious symptoms, and guidance for appropriate handover arrangements.

One of the three published versions of the guideline will be “designed to help patients and carers to make informed choices about their care.” (my italics)

3. The published research about hypopituitarism should have been found during the Scoping Search
During the Scoping Search phase, the Information Specialist of the Guideline Development Group had the responsibility of identifying the key clinical issues for inclusion. Medline is specifically given as a suggested source (see Guidelines Manual) and the most cursory search of Medline under ‘traumatic brain injury’ would have brought up many studies, ranging from an overview from as long ago as 1991 (Neuroendocrine Abnormalities in Patients with Traumatic Brain Injury, Yuan Wade) to the important 2005 paper Hypopituitarism following Traumatic Brain Injury – Call for Attention, by Popovic, Aimaretti, Casanueva, Ghigo.

Sadly, the Information Specialist failed to carry out this minimal search. Clearly his performance in this case severely compromised NICE’s quality assurance procedures.

4. The omission of hypopituitarism from CG56 satisfies two of the criteria of an ‘error’
To be considered an error, only one of the three criteria listed in 14.6.1 in your guidelines manual needs to be satisfied. Here they are:

Corrections or changes to a published clinical guideline will be made if an error
 May result in harm to patients
 Undermines the conclusions on which the recommendations have been based
 Indicates the NICE’s quality-assurance procedures have been seriously compromised

I consider that the first and third criteria are satisfied. (As regards patient safety, clearly, failing to diagnose a patient with hypopituitarism results in harm to him/her.)

I also consider the failure to include a warning in the sample discharge letter breaches NICE’s fundamental principle of respect for autonomy – the right of the patient to make ‘an informed choice’ about healthcare, which is mentioned in the Scope document. If he suffers depression or sexual dysfunction he will hardly refer himself to an endocrinologist unless he is warned that PTHP can cause these symptoms.

5. If an error is identified NICE has only two options – to deny or to correct
As I understand section 14.6.1, if an error is reported, Dr Macbeth and the NCC have to consider the suspected error. It seems there are then two options. Either Dr Macbeth decides there is no error and writes to me explaining the rationale for his decision. Or there is an error, in which case the error is corrected. There is no middle way.

6. Dr Macbeth has not informed me that there is no error
Dr Macbeth has not told me there is no error. On the contrary, as I have said, he does not ‘deny the scope for a disastrous outcome’ if hypopituitarism is not diagnosed. He promises that the matter will be addressed in the revised guideline when it comes out (I believe in autumn 2012). He clearly accepts that the guideline should contain this vital information.

7. If there is an error, NICE has an immediate obligation to correct it
The NICE Guidelines Manual gives no provision for postponing a correction for three years. If even only one patient might suffer harm as a result of their error there would be an obligation to put it right straight away. In fact, of course, in those three years it is likely that 30,000-45,000 patients will remain undiagnosed with PTHP. It is hard to see how anything can justify this.

In short, I believe NICE should correct CG56 without any further discussion.

Joanna Lane 19 July 2009



DOCUMENT 20

This letter from Professor Chris Thompson of Beaumont Hospital in Dublin dated 17 July 2009 is a pdf document and given in the Appendix.


DOCUMENT 21

28 Southwood Avenue
Coulsdon
CR5 2DT

Dr Fergus Macbeth
NICE
MidCity Place
71 High Holborn
LONDON
WC1V 6NA

30 July 2009

Dear Dr Macbeth

Updating CG56 Head Injury Guidelines

Thank you for your letter of 11 June informing me that in the light of unpublished research that shows ‘a very much lower incidence than previously seen,’ NICE does not feel an immediate update is justified. I have some points to make in reply which I will arrange under headings for clarity:-

The incidence is not diminished by this new research
I confess I could not see how one unpublished paper could negate the vast body of published research over the past ten years indicating that 25% of survivors of moderate/severe TBI have pituitary damage. I now find my disbelief was justified. An endocrinologist who is too eminent in the PTHP field to be mistaken, has written to me that ‘the vast majority of the published papers suggest figures of 20% to 30%’ and that a lower figure is ‘incorrect.’ I can only suppose that your new figure applies to all head injuries including mild, and there has been a misunderstanding. Clearly 10% of all head injury cases (of which there are 150,000 annually) comes to a larger number of people than 20-30% of mod/severe cases (of which there are only 21,000 annually).

Therefore I do not accept your rationale for not updating immediately. However I think you will see from my next point that the incidence figure is not the main issue, since NICE has a duty to correct the guideline regardless of the number of people affected.

There is a duty to correct immediately an error which may cause harm to patients and which severely compromises NICE’s Quality Assurance Procedures
I do not understand how the Information Specialist who conducted the Scoping Search for the 2007 update (and indeed the original 2003 version) managed to miss the mass of literature relating to PTHP but clearly the NICE’s quality assurance procedures have been severely compromised, while the harm that may be caused to patients by the omission hardly needs spelling out. I argue this point more fully in Attachment A which I have already emailed to Teresa Birch. When there is an error, your own rules allow only two options – NICE must deny the error exists and justify that denial, or to correct it immediately.

FOI request
I should say here that I have asked to see the cost-benefit calculation which justifies leaving around 45,000 head injury survivors needlessly undiagnosed with PTHP for the three years until the new guideline is published (Attachment B). We are talking about a condition which as you know can wreck relationships and lead to suicide. I understand that £20,000 per QALY is generally considered cost-effective and would be very surprised if the expense of updating the guideline, screening head injury patients and treating them, came to more than this, bearing in mind that someone like our son could have had 60 years of good quality life if diagnosed when symptoms began.

An MP is willing to ask a question in Parliament
Last month I was lucky enough to meet an MP whose particular concern is mental health, and when I described the PTHP problem she kindly expressed herself willing to ask a question in the House. At the time I believed that NICE’s own procedures would ensure the right outcome and her intervention would be unnecessary, and I still hope that this will be the case. However, if I do not receive confirmation of this by the 26 August (the anniversary of our dear son’s death, so an appropriate date) I believe my best option will be to approach her again.

Yours sincerely




Joanna Lane

Attached:
1. Attachment A: ‘The omission to mention hypopituitarism in CG56 was an error which may result in harm to patients’
2. Attachment B – summary of FOI request
3. Attachment C - List of PTHP literature

Copies to:
Mr Andrew Dillon, Chief Executive Officer, NICE
NICE, MidCity Place, 71 High Holborn, London WC1V 6NA

Ms Teresa Birch, Communications Officer, NICE
Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BD


Attachment A
The omission to mention hypopituitarism in CG56 was an error which may result in harm to patients

May I first draw attention to the title of CG56, Triage, assessment, investigation and early management of head injury in infants, children and adults noting in particular the words ‘assessment’ and ‘investigation.’ I would then like to review the process whereby the guideline was developed.

1. The scope clearly envisaged complications such as hypopituitarism
The original Scope document for CG56 (unchanged apparently since 2001) has a paragraph on ‘Clinical Need and Practice’ which contains the statement:

Most [head injury] patients recover without specific or specialist intervention but in others, persistent disability or even death results from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment. Much of the controversy and uncertainty in the early care of head injured patients is focused upon how these patients are best managed.

I need not labour the point that pituitary dysfunction is a complication that can result in persistent disability or even death. Dr Macbeth’s own words in his letter to me were “I am not denying the seriousness of this condition and the scope for a disastrous outcome if not recognised.”

2. The scope intended that the guideline should ensure such complications were detected
The scope document says ‘The guideline will not address the rehabilitation or longterm care of patients with head injury but the guideline will provide criteria for the early identification of patients who would benefit from rehabilitation. It continues that the guideline will include

information for patients and carers, and advice to primary care on the management of patients who re-present with suspicious symptoms, and guidance for appropriate handover arrangements.

One of the three published versions of the guideline will be “designed to help patients and carers to make informed choices about their care.” (my italics)

3. The published research about hypopituitarism should have been found during the Scoping Search
During the Scoping Search phase, the Information Specialist of the Guideline Development Group had the responsibility of identifying the key clinical issues for inclusion. Medline is specifically given as a suggested source (see Guidelines Manual) and the most cursory search of Medline under ‘traumatic brain injury’ would have brought up many studies, ranging from an overview from as long ago as 1991 (Neuroendocrine Abnormalities in Patients with Traumatic Brain Injury, Yuan Wade) to the important 2005 paper Hypopituitarism following Traumatic Brain Injury – Call for Attention, by Popovic, Aimaretti, Casanueva, Ghigo.

Sadly, the Information Specialist failed to carry out this minimal search. Clearly his performance in this case severely compromised NICE’s quality assurance procedures.

4. The omission of hypopituitarism from CG56 satisfies two of the criteria of an ‘error’
To be considered an error, only one of the three criteria listed in 14.6.1 in your guidelines manual needs to be satisfied. Here they are:

Corrections or changes to a published clinical guideline will be made if an error
 May result in harm to patients
 Undermines the conclusions on which the recommendations have been based
 Indicates the NICE’s quality-assurance procedures have been seriously compromised

I consider that the first and third criteria are satisfied. (As regards patient safety, clearly, failing to diagnose a patient with hypopituitarism results in harm to him/her.)

I also consider the failure to include a warning in the sample discharge letter breaches NICE’s fundamental principle of respect for autonomy – the right of the patient to make ‘an informed choice’ about healthcare, which is mentioned in the Scope document. If he suffers depression or sexual dysfunction he will hardly refer himself to an endocrinologist unless he is warned that PTHP can cause these symptoms.

5. If an error is identified NICE has only two options – to deny or to correct
As I understand section 14.6.1, if an error is reported, Dr Macbeth and the NCC have to consider the suspected error. It seems there are then two options. Either Dr Macbeth decides there is no error and writes to me explaining the rationale for his decision. Or there is an error, in which case the error is corrected. There is no middle way.

6. Dr Macbeth has not informed me that there is no error
Dr Macbeth has not told me there is no error. On the contrary, as I have said, he does not ‘deny the scope for a disastrous outcome’ if hypopituitarism is not diagnosed. He promises that the matter will be addressed in the revised guideline when it comes out (I believe in autumn 2012). He clearly accepts that the guideline should contain this vital information.

7. If there is an error, NICE has an immediate obligation to correct it
The NICE Guidelines Manual gives no provision for postponing a correction for three years. If even only one patient might suffer harm as a result of their error there would be an obligation to put it right straight away. In fact, of course, in those three years it is likely that 30,000-45,000 patients will remain undiagnosed with PTHP. It is hard to see how anything can justify this.

In short, I believe NICE should correct CG56 without any further discussion.

Joanna Lane 19 July 2009

Attachment B
SUMMARY OF FREEDOM OF INFORMATION REQUEST 22123

On 11 June Dr Fergus Macbeth wrote to me declining to do an immediate update on CG56 on the grounds that recent unpublished research had shown that there was a very much lower incidence of TBI-induced hypopituitarism than previously seen. He said “It’s important for us to target our resources in a way that gives the most benefit to the largest number of people.” I interpret this to mean that he had calculated the cost of an immediate update of CG56, and of the consequent diagnosis and treatment of patients with PTHP, and decided that this amount of money could benefit a larger number of people if spent in a different way.

In your publication SOCIAL VALUE JUDGEMENTS the following paragraph occurs under the heading Regulation:

It is particularly important for NICE to be ‘accountable for its reasonableness’ because it provides advice to the NHS. The NHS is funded from general taxation, and it is right that UK citizens have the opportunity to be involved in the decisions about how the NHS’s limited resources should be allocated.

I would like to see Dr Ferguson’s cost-benefit analysis
I am emboldened by the words quoted above to ask, as a tax-paying UK citizen, to see the cost-benefit analysis whereby Dr Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism so that it would not be published until (as we estimate) October 2012. During the delay I estimate that between 30,000 and 45,000 head injury patients will remain undiagnosed of a condition that seriously affects their quality of life. Many may suffer broken marriages and relationships as a result. Some may commit suicide.

Incidentally I understand that in general interventions with an ICER of less than £20,000 per QALY gained are considered to be cost-effective and I would imagine this would apply here.

I would like to see all documents generated by my April letter to Mr Dillon
I would like to see all the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June. This would include any notes resulting from his telephone conversation with the unnamed endocrinologist.

A question about your procedural principles
I understand from the section on ‘Procedural principles’ in Social Value Judgements that NICE would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. I would like to know what these exceptional circumstances are. I would also ask under what FOI exemption you are withholding this unpublished research from me.

On what grounds can NICE justify not warning patients of the risks they face?
Furthermore (with reference to the principle of ‘respect for autonomy’ described in the same document) I would like to know on what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time. If individuals have a right ‘to make informed choices about healthcare . . .and health protection’ it is crucial that they are given information about the risks they face.

I understand that I can expect to wait for 20 working days before I receive an answer to this FOI request.

Thank you very much for your help on this matter.
19 July 2009
Joanna Lane

Attachment C
Research relating to hypopituitarism after traumatic brain injury

Introductory note:
This does not pretend to be a comprehensive list of all the available literature, but is merely a record of the papers I have read in abstract. The vast majority of these papers suggest an incidence of 20-30% of hypopituitarism after traumatic brain injury. The studies are listed in reverse chronological order by publication year.

Pituitary and hypothalamic dysfunction after traumatic brain injury, Max Planck Institute of Psychiatry, 2009

Neuroendocrine disorders after traumatic brain injury, LA Behan, J Phillips, C J Thompson, A Agha, J. Neurol. Neurosurg. Psychiatry 2008; 79; 753-759.

Neuroendocrine consequences of traumatic brain injury, Acerini, Tasker, Pediatr Endocrinol Metab, 2008

Head-injury-induced pituitary dysfunction. An old curiosity rediscovered, Acerini C, Archives of Disease in Childhood 2008

Pituitary function in paediatric survivors of severe traumatic brain injury, P Poomthavorn, W Maixner, M Zacharin, Archives of Disease in Childhood 2008; 93;133-137.

Pathophysiology of hypopituitarism in the setting of brain injury, Dusick, Wang, Cohan, Swerdioff, Kelly, Pituitary 2008

Assessment of traumatic brain injury and anterior pituitary dysfunction in adolescents, De Sanctis, Sprocati, Govoni, Raiola, Georgian Med News 2008

Chronic hypopituitarism after traumatic brain injury: risk assessment and relationship to outcome, Bavisetty et al, Neurosurgery, 2008

Does the type and severity of brain injury predict hypothalamo-pituitary dysfunction? Does post-traumatic hypopituitarism predict worse outcome? Klose, Feldt-Rasmussen, Pituitary 2008

Is hypopituitarism predictable after traumatic brain injury? Liew, Thompson, Nature Clinical Practice Endocrinology & Metabolism 2008

The effects of head trauma on hypothalamic-pituitary function in children and adolescents. S Einaudi, C Bondone, Current Opinion in Pediatrics. 19(4):465-470, August 2007.

Hypopituitarism following traumatic brain injury, Agha, Phillips, Thompson, British Journal of Neurosurgery, 2007

Acute and long-term pituitary insufficiency in traumatic brain injury: a prospective single-centre study, Klose, Juul et al, Clin Endocrinol (Oxf) 2007
(study includes mild TBI)

A prospective longitudinal study of anterior pituitary dysfunction following traumatic brain injury, Kleindienst et al, Endocrine Abstracts 2007

The Neuroendocrine Effects of Traumatic Brain Injury, Rothman et al, J Neuropsychiatry Clin Neurosci, 2007

Evolving hypopituitarism as a consequence of traumatic brain injury (TBI) in childhood – call for attention, 2007, M -Medic-Stojanoska, S Pekic, N Curic, D Djilas-Ivanovic and V Popovic, Endocrine.

The effects of head trauma on hypothalamic-pituitary function in children and adolescents, Einaudi, Bondone Curr Opin Pediatr 2007

Managing patients with hypopituitarism after traumatic brain injury, Corneli, Ghigo, Aimaretti, Curr Opin Endocrinol Diabetes Obes, 2007

Hypothalamopituitary dysfunction following traumatic brain injury and aneurismal subarachnoid hemorrhage: a systematic review, Schneider, Kreitschmann-Andermahr, Ghigo, Stalla, Agha, JAMA 2007

Abnormalities of Pituitary Function after Traumatic Brain Injury in Children, Niederland etc al, Horm. Res. 2007

Traumatic Brain Injury-Induced Hypopituitarism in adolescence, R Baldelli, S Bellone, G Corneli, S Savastio, A Petri and G Bona Official Journal of the Pituitary Society, 2006

Traumatic Brain Injury Induced Hypopituitarism: The Need and Hope of Rehabilitation, Brent E Masel, Pituitary, 2006

Screening for Hypopituitarism Following Traumatic Brain Injury, Aimaretti et al, 2006, Minimally Invasive Neurosurgery and Multidisciplinary Neurotraumatology (book)

Hypopituitarism in childhood and adolescence following traumatic brain injury: the case for prospective endocrine investigation. Eur J Endocrinol. 2006;155;663-9.

Anterior pituitary hormone dysfunction after traumatic brain injury: less common than previously thought? Karavitaki et al Endocrine Abstracts 2006
(‘provides findings which are at odds with all of the other published literature’ according to eminent endocrinologist)

Prevalence of anterior pituitary insufficiency 2 and 12 months after traumatic brain injury, Schneider H J et al, European Journal of endocrinology/European Fed of Endocrine Societies, 2006

High Risk of Hypopituitarism after Traumatic Brain Injury: A prospective investigation of anterior pituitary function in the acute phase and 12 months after trauma, Tanriverdi et al, Journal of clinical Endocrinology & Metabolism, 2005

Consensus guidelines on screening for hypopituitarism following traumatic brain injury, Ghigo, Masel et al, Brain Inj. 2005

Epidemiology of Traumatic Brain Injury and Subarachnoid Hemorrhage, Leon-Carrion et al, Pituitary 2005

Variations of pituitary function over time after brain injuries: the lesson from a prospective study, Giordano, Aimaretti, Ghigo, Pituitary 2005

Anterior Pituitary Hormone Abnormalities following Traumatic Brain Injury, Schneider et al, Journal of Neurotrauma 2005

Anterior hypopituitarism following traumatic brain injury, Urban, Harris, Masel, Brain Injury Vol 19 2005

Brain Injury and Pituitary Dysfunction, 2005, Lisa B Nachtigall, Massachusetts General Hospital Neuroendocrine Clinical Center Bulletin

Hypopituitarism after traumatic brain injury, 2005, Bondanelli et al, European Journal of Endocrinology

Delay in diagnosis of Hypopituitarism after Traumatic Brain Injury, Aug 2005, Neuro Endocrinology Lett

High risk of hypogonadism after traumatic brain injury: clinical implications, Agha, Thompson, Pituitary, 2005

Traumatic brain injury and hypopituitarism, Aimaretti et al, TheScientificWorldJournal, 2005

Anterior Pituitary Dysfunction in Survivors of Traumatic Brain Injury, Agha et al, Journal of Clinical Endocrinology & Metabolism 2004

Neuroendocrine abnormalities in patients with traumatic brain injury, Yuan, Wade, Front. Neuroendocrinol. 1991

Hypopituitarism Secondary to Head Trauma, 1985, Benvenga et al, Journal of Clinical Endocrinology and Metabolism.


 

DOCUMENT 22a

From Teresa Birch to Joanna Lane sent 17 August 2009 15:48.

Dear Ms Lane,

FREEDOM OF INFORMATION ACT 2000: REFERENCE 22123

Thank you for your request for information, received at this office on 20 July 2009, in which you requested details of the following:

a) a) The cost-benefit analysis whereby Dr Fergus Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism.

b) b) All the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June.

c) c) In the Social Value Judgements document, NICE states it would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. What are these exceptional circumstances? Which FOI exemption is NICE relying on to withhold the senior endocrinologist’s unpublished research

d) d) On what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time.

I have set out the Institute’s response to your FOI request, and accompanying letter, below.

The cost-benefit analysis whereby Dr Fergus Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism.

NICE do not produce a cost-benefit analysis as part of our standard process for updating guidelines. Therefore, under the Freedom of Information Act 2000, we are unable to provide this for you as we do not hold this information.

When deciding whether to carry out a scheduled or unscheduled update of a guideline many factors are taken into account, but the direct cost of updating the guideline is not a criterion for decision.

It is incorrect to attribute the reference of ‘targeting our resources in a way that gives the most benefit to the largest number of people’ to the direct cost of producing an immediate update of the Head Injury guideline. This statement was intended to reflect the wider issues we face in our role as a guideline producer.
All the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June.

We have identified 26 documents for the period 29 April 2009 to 11 June 2009 which fall within the scope of this request.

The 14 documents we are disclosing are named: Doc 1, 2, 3, 7, 8, 9, 10, 11, 12, 13, 20, 21, 22 & 25. They are enclosed with this letter.

Personal data has been redacted in all documents where its disclosure is exempt under Section 40(2) of the Freedom of Information Act as it would contravene the Data Protection Act 1998. The details of all NICE staff below Senior Management Team level have been redacted.

In addition, data has been redacted in Doc 9 because it is exempt under Section 22, as the information is intended for future publication.

Documents 4, 5, 6, 14, 15, 16, 17, 18, 19, 23, 24 & 26 have not been disclosed as they contain information exempt from disclosure under Section 21 of the Act, as the information is reasonably accessible to the applicant by other means. For example, because the information has been provided by, or already sent to, the correspondent, or the information is repeated within the above disclosed documents.

In the Social Value Judgements document, NICE states it would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. What are these exceptional circumstances? Which FOI exemption is NICE relying on to withhold the senior endocrinologist’s unpublished research

Under the Freedom of Information Act, NICE is only obliged to release information to you if we hold the information.

The research referred to in Dr Fergus Macbeth’s letter of 11 June relates to a study which will be published at a later date. We hold no other information about this unpublished research.
As this research study is unpublished, the details discussed in Doc 9 are exempt from disclosure under s.22 of the Freedom of Information Act, as it is information that is intended for publication at a future date.

The Social Value Judgements document that you refer to describes the principles that NICE should follow in designing the processes it uses to develop its guidance, and in developing individual pieces of guidance.
The statement you have referred to from the document is taken out of context as it reads in full, ‘Only in exceptional circumstances does NICE accept unpublished evidence that must remain ‘confidential’ to protect the commercial or academic interests of a company or organisation.’

The statement above does not mean that NICE only accepts unpublished evidence in exceptional circumstances. It refers to a stage in our standard guideline development process which is explained in more detail below.

When we identify the evidence during guideline development, the Guideline Development Group (GDG) and National Collaborating Centre (NCC) staff may have good reason to believe that information exists that has not been found using standard searches. In these situations, the NCC may call for evidence from all registered stakeholders.

Stakeholders may submit relevant unpublished data or studies in response to a call for evidence, in addition to published studies. When the NCC sends out a call for evidence, it asks stakeholders that respond to complete a checklist that lists and identifies the location of all confidential information contained in their submission.

You can read more about the process we follow for identifying evidence in Chapter 5 of our guidelines manual.

We do not have set criteria for deciding in what circumstances we would accept unpublished evidence that must remain confidential because, due to the broad nature of evidence, this decision would need to be made on a case-by-case basis.

On what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time.

The suggested written discharge advice was produced in line with the scope which specifically addresses ‘the management at home of patients who are discharged within 48 hours of admission’.

Its purpose is to provide suggested advice to the NHS about what advice they should provide for patients and carers when discharging patients who have sustained a head injury within 48 hours.

Advice is given on long-term problems in the suggested written discharge letter. It states that

‘Most people recover quickly from their accident and experience no long-term problems. However, some people only develop problems after a few weeks or months. If you start to feel that things are not quite right (for example, memory problems, not feeling yourself), then please contact your doctor as soon as possible so that he or she can check to make sure you are recovering properly.’

It is not appropriate for us to update this document to warn about the possible danger of hypopituitarism as this does not reflect the original guideline scope, or the evidence that was considered during the development of the guideline.
The response time for your FOI request on this occasion was 20 working days.
If you are unhappy with the response to your Freedom of Information request and wish to make a formal complaint it must be made in writing by letter, fax or email within 20 working days of the Institute’s response to you and sent to:

Alana Christopher
Associate Director, Corporate Office
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London WC1V 6NA
Email: Alana.christopher@nice.org.uk

Once we have received your complaint, you will be sent an acknowledgement within two working days. The Associate Director, Corporate Office, will review your complaint and a full reply will be sent to you within 20 working days.

If you are not content with the outcome your complaint, you may apply directly to the Information Commissioner for a decision who can be contacted at: The Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.


When you originally approached NICE in November 2008, the Enquiry Handling Team referred your enquiry onto the National Collaborating Centre for them to consider whether the issues you raised warranted an exceptional update of the guideline. As you are aware Dr Fergus Macbeth also sought an independent opinion in addition to our usual process.

In investigating the issues you raised, we have moved away from focusing on the intended scope of the guideline which was ‘to provide recommendations on the early management of head injury.’

It is unfortunate that we did not explore the intended scope of the guideline with you in our earlier conversations but I hope the answers below help to explain and address the additional points in your accompanying letter.

1. The scope clearly envisaged complications such as hypopituitarism
2. The scope intended that the guideline should ensure such complications were detected

The referral received by the Department of Health and National Assembly for Wales asked NICE to provide guidance to A & E departments about:

 which patients can go home without admission to hospital,
 which patients with a relatively minor injury require admission to a hospital for a short period, i.e. not more than 48 hours,
 which patients require transfer to a neurosurgical unit and may require neurosurgery,
 after discussion with neurosurgeons, which severely head-injured patients do not require neurosurgical intervention but do require admission to a neuroscience unit,
 which accompanying injuries require the involvement of other specialities.

The intended focus of the guideline was to provide recommendations on the early management of head injury. Addressing the long-term management of head injured patients was outside of the scope of this particular guideline.

3. The published research about hypopituitarism should have been found during the scoping search

The scoping search is carried out after review questions have been developed and is designed to address all areas covered by the scope. Review questions are refined and agreed by all GDG members through discussions at GDG meetings. The different perspectives among GDG members ensures that the right review questions are identified, thus enabling the literature search to be planned efficiently.

The key clinical questions developed for this update were:

1 In deciding on the most appropriate destination for a patient with severe head injury, what are the benefits of direct transport to a specialist neurosciences centre compared to transport to the nearest district general hospital?
2 For patients who have suffered a clinically important brain injury that does not require surgical intervention and who have been transported to a non specialist centre, what are the benefits of the patient continuing on receiving treatment at that district general hospital versus being transferred to a neurosciences centre?
3 What is the best initial diagnostic technique to determine which patients have sustained damage to the head and require further assessment of the head?
4 What is the best clinical prediction rule for selecting patients with head injury for the imaging technique selected in question 3?
5 What is the best diagnostic technique to determine which patients have sustained damage to the cervical spine and require further assessment of cervical spine?
6 What are the best clinical prediction rule(s) for selecting patients that have sustained damage to the cervical spine for the imaging technique selected in question 5?
7 What is the harm associated with radiation to the head and/or spine?
8 Which is the best tool for identifying the patients who should be referred to rehabilitation services following the initial management of a head injury?

The scoping search did not focus on identifying studies relating to hypopituitarism as this did not address the review questions above.

The search strategies used in the development of this guideline are included with this letter.

4. The omission of hypopituitarism from CG56 satisfies two of the criteria of an ‘error’
5. If an error is identified NICE has only two options – to deny or to correct
6. Dr Macbeth has not informed me that there is no error
7. If there is an error, NICE has an immediate obligation to correct it

We do not consider that the omission of hypopituitarism from the Head Injury guideline is an error as our remit was to produce a guideline that focused on the triage, assessment, investigation and early management in infants, children and adults.

As you are already aware NICE and the NCC will not actively seek new evidence on an ongoing basis, beyond collating post-publication comments, unless it has been identified in the guideline that important new information is likely to emerge before the 3-year scheduled review. In such instances, the NCC is responsible for alerting NICE to the new evidence and advising on the need for an exceptional update or amendment.
Both the NCC and Dr Macbeth have considered the points you have raised since November 2008. Both have advised that the omission of hypopituitarism does not warrant an unscheduled update of the guideline.

NICE has not yet been asked to produce national guidance on the long term conditions following a head injury or on hypopituitarism. If you think that this is a topic that we should look at, you can formally suggest it to us. Anyone can suggest a topic for the NICE work programme via the “get involved” section of the NICE website at www.nice.org.uk. Details about the criteria and selection process can also be found in this section.

We appreciate that you remain unhappy with our decision not to update the guideline but we feel we have now reached a point where it is not helpful to continue to debate this issue any further. We have addressed your FOI request and a number of further issues but we are unable to enter into further discussion with you about this guideline.

If you wish to formally complain about the way in we have handled your non-FOI enquiries, please write to the Institute, stating your concerns clearly, to:

Alana Christopher
Associate Director, Corporate Office
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London WC1V 6NA
Email: Alana.christopher@nice.org.uk

If you are unhappy with the initial response from the Associate Director- Corporate Office, you can ask for it to be reviewed by the Chief Executive, who may ask another director to undertake the review. If you remain dissatisfied, the complaint will be reviewed by a panel of two non-executive directors. If, following a non-executive director review, you are still unhappy with the decision of the Institute, you should be referred to the Parliamentary and Health Service Ombudsman.

A copy of this response is also being sent to you in the post.

Yours sincerely,


Teresa Birch
Communications Manager (Enquiry Handling)


DOCUMENT 22b (attached to Document 22a)


This consists of 14 pdf documents which are given in Appendices 4-17.



DOCUMENT 23
28 Southwood Avenue
Coulsdon
CR5 2DT

Ms Alana Christopher
Associate Director, Corporate Office
NICE
MidCity Place
71 High Holborn
London WC1V 6NA

10 September 2009


Dear Ms Christopher

I have been in correspondence with Ms Teresa Birch and Dr Fergus Macbeth since last November putting the case that NICE should do an exceptional update on their Head Injury guideline CG56, to include the high risk of pituitary dysfunction following moderate/severe traumatic brain injury, and to modify the sample discharge letter to warn that hypopituitarism may occur after a long interval, even after mild injury, but can be treated. On 17 August I heard their decision, that NICE will include the information in their next update in 2012, but not do an exceptional update.

I would like to lodge an appeal against this decision on the grounds that NICE:

 did not take into account the relevant research and were under a misapprehension about the number of people at risk
 misinterpreted the scope of CG56
 failed to demonstrate the truth of their statement that an exceptional update would not be targeting resources “in a way that gives the most benefit to the largest number of people” with a cost-benefit calculation

My brother-in-law Sir David Lane, FRS, FRSE, FRCPath, FRCS (Edin) F Acad Med Sci, FUCL, of whose discovery of the P53 gene Dr Macbeth is no doubt aware in his capacity as cancer specialist, has advised me that the first step in my appeal should be to ask you to examine the research on which I have based my estimate of how many people are affected. I quoted an annual incidence figure of 10,000-15,000 to Dr Macbeth. I have attached a document describing the research, and all I would ask from you at this stage is to decide whether you yourself agree with this figure, and if not, to provide your own estimate giving your reasons.

I will wait for your response.

Yours sincerely



Joanna Lane BA (Hons) Oxon

DOCUMENT 23 Attachment 1:

THE SCOPE OF CG56 AND THE NEED TO AMEND THE SAMPLE DISCHARGE LETTER

The scope of CG56 does include the diagnosis of complications which may lead to longterm disability
Dr Macbeth and his team claim that hypopituitarism falls outside the scope of CG56. However the original Scope document dated 2003 given in Appendix A of the full guideline says: “Most patients recover . . but in others, persistent disability or even death result from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment. Much of the controversy and uncertainty in the early care of head injured patients is focused upon how these patients are best managed.”

The scope document goes on to say that the guideline, while not addressing rehabilitation or long term care, ‘will provide criteria for the early identification of patients who would benefit from rehabilitation.’

This gives an unequivocal mandate for screening for a longterm complication such as neuroendocrine dysfunction.

Dr Macbeth’s team argue that this is the scope for the 2003 version, and that the 8 questions they were required to address for the 2007 update only related to getting head injured cases to expert care in a timely fashion, and that therefore they fulfilled their remit. However 1.17 of the full guideline published 2007 clearly states “Only 8 clinical questions . . are covered within this partial update; all other criteria set in the scope (Appendix A) were adhered to in this update.” The Scope in Appendix A is of course the 2003 Scope.

It is obvious that this must be so. Otherwise it would be illogical for a partial update to share the same status as a full update, as it does, and be valid for the same number of years. It would be like saying “We changed the windscreen wipers so we’re excused from doing an MOT.”

Dr Macbeth has therefore misunderstood the scope of CG56 and is incorrect in his objection that hypopituitarism falls outside it. In any case, by agreeing to include the information in the 2012 update he is tacitly admitting that it belongs there.

The discharge letter
The other very strong reason for amending the guideline is this. Bearing in mind that the onset of PTHP can come long after the injury [1, 2, 3] – even mild injury – it is essential to warn patients at the time of discharge. Otherwise who is going to check on them ten years later? How are they going to connect their misery and sexual failure with a head injury years ago, perhaps in childhood, and how will they know that they can be successfully treated?

Dr Macbeth’s team rests argues that the present sample discharge letter says ‘Most people recover quickly . . however some people only develop problems after a few weeks or months. If you start to feel that things are not quite right (for example, memory problems, not feeling yourself) then please contact your doctor as soon as possible . .’ However, I hardly need to point out that some vague words about ‘not feeling yourself’ in a few months’ time form no sort of adequate warning for a dreadful condition that may begin ten years into the future,.

References
[1] Hypopituitarism Secondary to Head Trauma, Benvenga S, Campenni A, Ruggeri R, Trimarchi F, J. Clin. Endocrin. & Metab. 2000.
http://jcem.endojournals.org/cgi/content/full/85/4/1353
A table of 15 survivors shows three males who had head injuries aged 11, 10 and 10 who were not diagnosed until ages 52, 45 and 40. Obviously these 3 boys must have grown normally during adolescence for their diagnosis to be so delayed.

[2] Brain Injury and Pituitary Dysfunction, Nachtigall L B, Massachusetts General Hospital Neuroendocrine Clinical Centre Bulletin, 2005.
http://www.massgeneral.org/endocrine/assets/pdfs/neuroendocrine/clinicalcenterbulletin/2005_v11_i2_brain_injur y_and_pituitary_dysfunction.pdf
“Longitudinal follow-up is necessary, as . . . some [patients] develop hypopituitarism as a late manifestation many years after the initial event.”

[3] Hypopituitarism after traumatic brain injury, Bondanelli et al, European Journal of Endocrinology, 2005
http://www.eje-online.org/cgi/content/abstract/152/5/679
“Diminished pituitary hormone secretion, caused by damage to the pituitary and/or hypothalamus, may occur at any time after traumatic brain injury.”


DOCUMENT 23 Attachment 2

POST-TRAUMATIC HYPOPITUITARISM – SYMPTOMS AND INCIDENCE

Symptoms
The pituitary gland controls the production of growth hormone, adrenocorticotrophic hormone which governs response to stress, and the glands that produce sex hormones. Damage to the pituitary can produce varying symptoms including loss of libido, erectile dysfunction in men, amenorrhea in women, infertility and depression.

The incidence of post-traumatic hypopituitarism after moderate to severe traumatic brain injury is well established at 25%
Since last August I have built up a collection of papers on PTHP which fills two lever-arch files. All these studies, starting with Daniel Kelly's 2000 paper and carrying through until now, and published by the Journal of Neurosurgery, Journal of Neurotrauma, Journal of Neurology, Neurosurgery and Psychiatry, JAMA, Pituitary etc, written by authors from many different countries, give incidences ranging from 20% to 50% for mod/severe injuries, but generally around the 25% mark. The only exception I can find is a paper by Karavitaki and Wass in 2006. I also have a letter from Professor Chris Thompson from Dublin, who has been responsible for much of the research himself, assuring me that the accepted figure of 20-30% after mod/severe injury still applies. I have his permission to quote him on this. Furthermore, Mr Antonio Belli at Southampton General has written to me that he is screening severe TBI patients and finding that one in four needs hormone replacement.

I believe the figure of 25% following moderate to severe TBI is as unassailable as 30 years of research and a series of large-scale studies and data reviews [1,2,3] culminating in a systematic review covering 19 studies including 1137 patients can make it. [4].

There are about 150,000 traumatic brain injuries a year in the UK [CG56 Appendix A]. Of these 15% are moderate to severe, i.e. around 22,500 [“Effects of Brain Injury” Headway leaflet]. A quarter of this comes to 5,600 cases. For the purposes of comparison, it may be helpful to observe that 7,237 patients were diagnosed with leukaemia and 7,600 with pancreatic cancer in the year 2006 [CRUK website].

The incidence of PTHP after all traumatic brain injury including mild is less well established
In the case of the 137,500 mild TBI cases the picture is less clear. PTHP is well documented to occur after mild injury, sometimes so mild that the patient does not remember it himself and has to be prompted by family members. [5, 6]. However the incidence after all head injury including mild is much less consistently recorded, and here I believe the figure ranges from 50% [7] from a study using 71 consecutive patients, to 16% [8] (a study involving 104 patients) and to 7-10% (I quote from an email from Dr Tara Kearney to Mr Stephen Greep at Hull Royal Infirmary which she copied me in on, basing her figure on unnamed research). To be conservative I took Dr Kearney’s incidence, which gives 10,000-15,000, and this was the figure I gave to NICE. In other words, even the most conservative current research suggests there as many people with PTHP as there are people diagnosed with pancreatic cancer and leukaemia put together.


References
[1] Anterior pituitary dysfunction in survivors of traumatic brain injury Agha A, Rogers B, Sherlock M et al, J Clin Endocrinol Metab 2004
http://www.ncbi.nlm.nih.gov/pubmed/15472187?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum&log$=freejr
Tested 102 consecutive mod/severe TBI survivors, found hypopituitarism in 28.4%

[2] Anterior Pituitary Hormone Abnormalities following Traumatic Brain Injury, Schneider M, Schneider HJ, Stall GK, J. Neurotrauma 2005 http://www.ncbi.nlm.nih.gov/pubmed/16156709
Reviews 5 studies including 364 patients, ‘partial anterior hypopituitarism after TBI is a common finding with a prevalence of at least 30%.’

[3] Neuroendocrine disorders after traumatic brain injury, Behan LA, Phillips J, Thompson CJ, Agha A, J Neurol Neurosurg Psychiatry 2008
http://jnnp.bmj.com/cgi/content/full/79/7/753
Summarizes data from 12 studies covering 961 TBI patients giving prevalence of anterior hypopituitarism as approximately 25%.

[4] Hypothalamopituitary Dysfunction Following Traumatic Brain Injury and Aneurysmal Subarachnoid Hemorrhage: A Systematic Review, Schneider HJ, Kreitshmann-Andermahr I, Ghigo E et al, JAMA 2007
http://jama.ama-assn.org/cgi/content/full/298/12/1429
Reviews 19 studies including 1137 patients. Pooled prevalences of hypopituitarism in chronic phase after TBI and SAH were 27.5% and 47% respectively.

[5] Hypopituitarism Secondary to Head Trauma, Benvenga S, Campenni A, Ruggeri R, Trimarchi F, J. Clin. Endocrin. & Metab. 2000.
http://jcem.endojournals.org/cgi/content/full/85/4/1353
“We learned that head trauma can be minor and had occurred several years earlier, so that the patient may lose recollection of it” Re late onset, a table of 15 survivors shows three males who had head injuries aged 11, 10 and 10 who were not diagnosed until ages 52, 45 and 40. Obviously these 3 boys must have grown normally during adolescence for their diagnosis to be so delayed.

[6] Should every patient with traumatic brain injury be referred to an endocrinologist? Aimaretti G, Ghigo E, Nature Clinical Practice Endocrinology & Metabolism, 2007
http://www.nature.com/nrendo/journal/v3/n4/full/ncpendmet0460.html
“It has been reported the severe hypopituitarism could occur in patients who have suffered mild head trauma(GCS 13-15), which suggests the need for endocrine evaluation in this patient group. Unfortunately, however, this type of trauma is often so minor that patients have no recollection of its occurrence, even after direct questioning, and only family members are able to remember the event.”

[7] A prospective longitudinal study of anterior pituitary dysfunction following traumatic brain injury, Kleindienst A et al, Endocrine Abstracts 2007.
http://www.endocrine-abstracts.org/ea/0013/ea0013p231.htm
71 consecutive survivors of mild, moderate and severe TBI prospectively studied at acute stage and after 2-3 years. 50% showed hypopituitarism at 2-3 years.

[8] Prevalence of predictive factors of post-traumatic hypopituitarism, Klose M et al, Clin Endocrinol (Oxf) 2008
http://www.ncbi.nlm.nih.gov/pubmed/17524035
A study of 104 survivors of mild, moderate and severe traumatic brain injury. 16% had pituitary dysfunction.


DOCUMENT 24

From: “Alana Christopher” Alana.Christopher@nice.org.uk
To: “Joanna Lane” joannalane@blueyonder.co.uk
Sent: 09 October 2009 19:42
Subject: RE: updating CG56

Dear Ms Lane,

I am writing further to your email of 11th September 2009, regarding your request for an exceptional update of Head Injury guideline (CG56). I have now reviewed the matters you raised in accordance with the Institute’s complaints procedure.
I am sorry that you were not satisfied with the response to your Freedom of Information request.
You have appealed against this decision on the grounds that NICE:

 did not take into account the relevant research and were under a misapprehension about the number of people at risk
 misinterpreted the scope of CG56
 failed to demonstrate the truth of their statement that an exceptional update would not be targeting resources “in a way that gives the most benefit to the largest number of people” with a cost-benefit calculation

In preparing my response, I have taken advice from those at NICE who have knowledge of the guideline.

The key issue is whether or not the topic of hypopituitarism following head injury was or was not within the scope of the original and updated guideline. Although you quite correctly quote the scope document as saying that ‘Most patients recover ... but in others, persistent disability or even death result from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment’ this comes from the introductory background section entitled ‘Clinical need and practice’. The scope itself is defined in the following three sections (Population, Healthcare setting and Interventions and treatment). In these it is clear that the clinical guideline was only to cover the early management of patients with head injury. The scope was consulted on and agreed at that time. In our view it does not include the identification and management of the late complications of head injury such as pituitary failure.

We therefore do not believe that the scope was misinterpreted when being considered for update and the question of whether or not the relevant evidence on the incidence of pituitary failure was taken into account is not relevant. If the guideline had included follow up and long term management of complications had been within the scope the situation would of course be very different.

In your email, you stated that NICE has not demonstrated the cost benefit analysis on which NICE decided not to update the clinical guideline on head injury. The decision whether or not to update a clinical guideline is not informed by a health economic analysis and there is no methodology for doing that. That decision is made only on the extent to which the evidence base has changed and any decision to update the guidance is then prioritised on the basis of our available capacity.

Your email also stated that the sample discharge letter should warn that hypopituitarism may occur after a long interval. As you know the guideline did include a recommendation which said: ‘All patients and their carers should be made aware of the possibility of long-term symptoms and disabilities following head injury and should be made aware of the existence of services that they could contact should they experience long-term problems. Details of support services should be included on patient discharge advice cards. This did not prescribe what should exactly be included in that information and could not do, because long term consequences had not been formally reviewed for the guideline.

As an acknowledgment of the possible importance of this topic, we think it may be helpful to propose the development of a clinical guideline on the identification of pituitary failure following head injury. We will need to discuss the proposal with the Department of Health, which commissions NICE to prepare guidance for the NHS. Given that there are already a number of clinical guideline topics waiting to be considered for development, I am not able to guarantee that we will be able to take this one forward.
.
Neither I nor Dr Macbeth can comment on the accuracy of your estimate of the incidence of the condition but this will be carefully considered when a proposal for a clinical guideline on the topic is prepared. In addition to the evidence which you have helpfully cited, we are also aware of the very recently published paper from Germany (Exp Clin Endocrinol Diabetes 2009 Aug 18) reporting that 20% of 246 patients had biochemically identifiable pituitary dysfunction following traumatic brain injury.
I hope this information is helpful. If, however, you are unhappy with this decision you can request a review by the Chief Executive of NICE in accordance with the Institute’s complaints procedure that you have been sent.

Yours sincerely


Alana Christopher
Associate Director - Corporate Office


DOCUMENT 25

From: Joanna Lane
To: Alana Christopher
Sent: Friday, October 23, 2009 8:27 AM
Subject: I wish to appeal against your decision on CG56

Dear Ms Christopher

Thank you for your response to my appeal, and for going through my points so carefully. Thank you also for the suggestion that you might develop a clinical guideline on the identification of pituitary failure following head injury. This is a good suggestion and I agree, though it will take a few years and not solve the immediate crisis.

As you say, much hinges on the scope, and also I think on the number of people who will be affected. The discharge letter also merits discussion. I will take these points in turn.

The scope
I believe any impartial reader of the "Background and Scope" section (pp 30-40 of the full guideline) would summarise it as follows. "The guideline is intended to guide professionals in managing the acute stage of head injury in such a way as to minimize later complications." To claim that the guideline covers "early management", full stop, is seriously to truncate and misrepresent the scope.
I conclude this not only because of the comments I referred to before, in Appendix A, 3.5, about complications causing 'persistent disability or even death' which can be 'minimised with early detection and treatment', but also because of the following specific and unambiguous sentences in 4.11 and 6.18.3.
 The guideline will provide criteria for the early identification of patients who would benefit from rehabilitation
 The guideline will include . . secondary care with the aim of early detection of intracranial complications . . the aim is . . to arrange for appropriate diagnostic procedures and treatment.
I am puzzled by your silence about these parts of the scope. I cannot think you wish to imply that the pituitary is not situated in the cranium and that damage to it is not a 'complication', or that hormone replacement does not form a part of the patient's rehabilitation, the process whereby he/she is helped to live a normal life again.

I will cite here also the statement from 6.18.3, that the guideline will advise of tne appropriate use of imaging procedures such as CT scans. Pituitary damage can potentially (though not invariably) be picked up by scans. It would seem an obvious step to examine the pituitary in the acute stage at the same time as checking for intracranial haemorrhage etc, on the grounds that:
 ACTH deficiency is life-threatening in the acute stage
 the probability of the fragile pituitary being damaged is so high (20-30%) in injuries below 13 on the Glasgow Coma Scale
 doing a separate scan later for pituitary damage would double the expense
For your interest I attach an article with an image of a damaged pituitary gland (Fig 3). The patient, with whom I have corresponded, had a serious head injury aged 20. She was not diagnosed with pituitary trouble for 10 years, during which time she had five miscarriages and a still-birth. A scan of her pituitary at the time of her accident might have saved her much heartache.

The number of people affected
I was interested in the new research you mentioned where 20% of the 246 mod/severe patients had pituitary damage. This fits with Professor Chris Thompson's letter to me putting the incidence at 20-30%. When this research is 'put into the pot' with Schneider's systematic review covering 1137 patients and giving 27.5% incidence, it brings the incidence down to about 26%.
I was disappointed that you and Dr Macbeth did not share with me the conclusions you must have come to between yourselves about how many people are affected each year. I am inclined to infer from this that you do not seriously challenge my figure of between 10,000 and 15,000 people annually - an estimate which was very conservatively arrived at.
Although you say that cost is not a factor in deciding whether to do an exceptional update, I think it does have some influence. Dr Macbeth not only mentioned it to me ("it's important for us to target our resources in a way that gives most benefit to the largest number of people") but also in his email of 5 June to an unnamed endocrinologist "Her view is that this is a 'serious error' that would justify .. further guidance being issued. This would of course entail considerable resource to do, and we could not do it unless there was sufficient justification.") To me, the risk of 30,000 to 45,000 pituitary patients remaining undiagnosed over the next 3 years is sufficient justification, and I feel that now you have examined the research in more detail you must agree with me.

Discharge letter
I agree that NICE does not dictate to hospitals what the discharge letter should say.
However the reality is that hospitals copy the NICE sample discharge letter verbatim. If the discharge letter isn't reliable or complete there should be a disclaimer, to protect the hospital (and indeed NICE) from legal action later. But how much better than a disclaimer would be a few words inserted now, at very little cost, which would keep the patient safe!

In summary then, I wish to appeal against your decision for three reasons:

 You have misunderstood the scope of CG56
 Too many patients will suffer harm over the next 3 years to leave the guideline unchanged
 The sample discharge letter is unreliable and incomplete

Yours sincerely

Joanna Lane BA (Hons) Oxon


DOCUMENT 26

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 30 October 2009 21:58
To: Andrew Dillon
Subject: Fw: I wish to appeal against your decision on CG56

Dear Mr Dillon

I believe I should have sent this to you rather than Ms Christopher.

Yours sincerely

Joanna Lane

----- Original Message -----
From: Joanna Lane
To: Alana Christopher
Sent: Friday, October 23, 2009 8:27 AM
Subject: I wish to appeal against your decision on CG56

Dear Ms Christopher

Thank you for your response to my appeal, and for going through my points so carefully. Thank you also for the suggestion that you might develop a clinical guideline on the identification of pituitary failure following head injury. This is a good suggestion and I agree, though it will take a few years and not solve the immediate crisis.

As you say, much hinges on the scope, and also I think on the number of people who will be affected. The discharge letter also merits discussion. I will take these points in turn.

The scope
I believe any impartial reader of the "Background and Scope" section (pp 30-40 of the full guideline) would summarise it as follows. "The guideline is intended to guide professionals in managing the acute stage of head injury in such a way as to minimize later complications." To claim that the guideline covers "early management", full stop, is seriously to truncate and misrepresent the scope.
I conclude this not only because of the comments I referred to before, in Appendix A, 3.5, about complications causing 'persistent disability or even death' which can be 'minimised with early detection and treatment', but also because of the following specific and unambiguous sentences in 4.11 and 6.18.3.
 The guideline will provide criteria for the early identification of patients who would benefit from rehabilitation
 The guideline will include . . secondary care with the aim of early detection of intracranial complications . . the aim is . . to arrange for appropriate diagnostic procedures and treatment.
I am puzzled by your silence about these parts of the scope. I cannot think you wish to imply that the pituitary is not situated in the cranium and that damage to it is not a 'complication', or that hormone replacement does not form a part of the patient's rehabilitation, the process whereby he/she is helped to live a normal life again.

I will cite here also the statement from 6.18.3, that the guideline will advise of tne appropriate use of imaging procedures such as CT scans. Pituitary damage can potentially (though not invariably) be picked up by scans. It would seem an obvious step to examine the pituitary in the acute stage at the same time as checking for intracranial haemorrhage etc, on the grounds that:
 ACTH deficiency is life-threatening in the acute stage
 the probability of the fragile pituitary being damaged is so high (20-30%) in injuries below 13 on the Glasgow Coma Scale
 doing a separate scan later for pituitary damage would double the expense
For your interest I attach an article with an image of a damaged pituitary gland (Fig 3). The patient, with whom I have corresponded, had a serious head injury aged 20. She was not diagnosed with pituitary trouble for 10 years, during which time she had five miscarriages and a still-birth. A scan of her pituitary at the time of her accident might have saved her much heartache.

The number of people affected
I was interested in the new research you mentioned where 20% of the 246 mod/severe patients had pituitary damage. This fits with Professor Chris Thompson's letter to me putting the incidence at 20-30%. When this research is 'put into the pot' with Schneider's systematic review covering 1137 patients and giving 27.5% incidence, it brings the incidence down to about 26%.
I was disappointed that you and Dr Macbeth did not share with me the conclusions you must have come to between yourselves about how many people are affected each year. I am inclined to infer from this that you do not seriously challenge my figure of between 10,000 and 15,000 people annually - an estimate which was very conservatively arrived at.
Although you say that cost is not a factor in deciding whether to do an exceptional update, I think it does have some influence. Dr Macbeth not only mentioned it to me ("it's important for us to target our resources in a way that gives most benefit to the largest number of people") but also in his email of 5 June to an unnamed endocrinologist "Her view is that this is a 'serious error' that would justify .. further guidance being issued. This would of course entail considerable resource to do, and we could not do it unless there was sufficient justification.") To me, the risk of 30,000 to 45,000 pituitary patients remaining undiagnosed over the next 3 years is sufficient justification, and I feel that now you have examined the research in more detail you must agree with me.

Discharge letter
I agree that NICE does not dictate to hospitals what the discharge letter should say.
However the reality is that hospitals copy the NICE sample discharge letter verbatim. If the discharge letter isn't reliable or complete there should be a disclaimer, to protect the hospital (and indeed NICE) from legal action later. But how much better than a disclaimer would be a few words inserted now, at very little cost, which would keep the patient safe!

In summary then, I wish to appeal against your decision for three reasons:

 You have misunderstood the scope of CG56
 Too many patients will suffer harm over the next 3 years to leave the guideline unchanged
 The sample discharge letter is unreliable and incomplete

Yours sincerely

Joanna Lane BA (Hons) Oxon



DOCUMENT 27

----- Original Message -----
From: Andrew Dillon
To: 'Joanna Lane'
Cc: Alana Christopher ; Fergus Macbeth
Sent: Monday, November 30, 2009 11:42 AM
Subject: RE: I wish to appeal against your decision on CG56

Dear Ms Lane,

Thanks you for your email. I am sorry for the delay in responding to it. I have spoken to both Alana Christopher and Dr Fergus Macbeth about the responses they have sent to your earlier correspondence.

Although it has no effect on my response to your most recent email, I just wanted to let you know how we have been dealing with your enquiries.

You originally approached us using the Freedom of Information Act and we responded accordingly. All the information we hold, which we are able to give you and which relates to your enquiries, has been released. Although we were happy to respond under our Freedom of Information Act procedure, it was quickly obvious that your real aim has been to persuade us to review our clinical guideline on the triage, assessment, investigation and early management of head injury in infants, children and adults. Our recent correspondence has therefore been outside of the Freedom of Information Act and we have continued it because we understand the matter is important to you and because we do our best to engage with members of the public when they approach us with concerns about our work. I mention all this partly because I want you know that we have taken your enquiries seriously and because, although you refer to your recent email as an ‘appeal’ we are not treating it as such, since we are not engaged in a process which has an appeal stage to it.

In reviewing our earlier correspondence, my concern has been to make sure that we have balanced your arguments for a different interpretation of the scope. However broadly the scope, as set out in the full guideline, could be interpreted, it was not intended to identify and cover all the potential complications of head injury. It was reasonable for the Institute and the guideline developers to identify the limits of what they considered to be ‘early management’. This leads me to take the view that the interpretation of the scope was a reasonable one and that to exclude the identification and management of late complications was consistent with the Department of Health’s intention in commissioning the guideline from us.

In saying this. I do understand that a proportion of patients with a head injury will develop biochemically identifiable pituitary abnormalities. However, I do not consider that this constitutes a sufficient risk of serious harm to justify incorporation into this guideline as an immediate update. Nor have we been made aware from independent sources, in the NHS, that there is a 'crisis' with this condition that needs immediate remedy. The decision to refer the topic into the selection process for clinical guidelines is both appropriate and proportionate, given the importance of the issue and the need for us to balance our guideline development capacity across all the demands made on clinical services provided by the NHS.

I am not really able to add to the points that have already been made in our earlier corresoondence about the discharge letter. I understand that you feel that it is unsatisfactory and unsafe because it does not make specific reference to the possibility of pituitary problems. However, it does draw attention to the risk of long term problems, (of which, of course, pituitary failure is just one) and advises that some people only develop problems after a few weeks or months. It also recommends that patients should contact their doctor as soon as possible if they feel that things are not quite right, for example, if they are experiencing memory problems, or otherwise not feeling well. This approach seems balanced and proportionate to the likelihood of complications. It could be argued that it would be inappropriate and potentially alarming to enumerate all the possible late effects and their clinical symptoms in a document which is intended to help make patients aware of the possibility of complications and the need to seek advice when that might be the case. .

I appreciate that this is not the response you will have been hoping for, nor, I suspect, will you agree with it. However, we have to make judgements about how best to apply our resources and I believe that the position we have taken is reasonable in the circumstances, even though I accept that an alternative view can be argued.

We will be happy to keep you up to date with progress in considering the matter as a separate clinical guideline, if you wish.

Yours sincerely,

Andrew Dillon
Chief Executive
National Institute for Health and Clinical Excellence


DOCUMENT 28

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 07 January 2010 16:50
To: Andrew Dillon
Cc: Alana Christopher; Fergus Macbeth
Subject: Re: I wish to appeal against your decision on CG56

Dear Mr Dillon

I hope you had a good Christmas.

Thank you for explaining your reasons for not doing an exceptional update on CG56.

However, your refusal is predicated on the assumption that post-traumatic hypopituitarism is a 'late complication.'

It is not a late complication. It is an early one. If you refer to Schneider's systematic review (link sent to NICE on 11/9/09 http://jama.ama-assn.org/cgi/content/full/298/12/1429 ) you will see that the highest incidence comes at the acute stage, where percentages of up to 80% have been recorded. At this stage deficiency of thyroid-stimulating hormone, adrenocorticotrophic hormone and anti-diuretic hormone have all been associated with high mortality.

To sum up then: both your 2003 and 2007 guidelines omitted to mention a common, life-threatening complication included in the narrowest definition of the scope. This is an error which puts patients at risk and by your own rules you are obliged to correct it immediately. You do not have the latitude to 'balance your guideline development capacity' across the demands. It is like a parking fine. However inconvenient, you have to grit your teeth and pay.

With best regards

Joanna Lane



DOCUMENT 29

Sent by Mr Andrew Dillon to Joanna Lane on 11 January 2010 12:03


Dear Ms lane,

Thank you for your email.

I agree that the systematic review which you cite refers to evidence that the incidence of biochemically identified hypopituitarism is higher in the acute phase. The figure of 80%, which you refer to, is for LH/FSH (gonadotrophins) only, and only in one of the two studies. The rate of ACTH deficiency, which if severe would be the only life threatening complication, is cited as 12%. The clinical significance of these biochemical findings is not clear. The review itself states that: ‘Early posttraumatic pituitary dysfunction can be transient in many cases and conversely, hypopituitarism can evolve over several weeks or months after injury.’

In addition, the abstracts of two papers listed at the end as citing this paper include the following two statements:

‘By applying strict diagnostic criteria to an emergency-department-based cohort of TBI patients, it was shown that anterior pituitary dysfunction is rare (<1%). Routine pituitary screening in unselected patients after TBI is unlikely to be cost-effective.’ van der Eerden et al (2010)

‘The reported variations in the prevalence rates of hypopituitarism after TBI are in part caused by differences in definitions, endocrine assessments of hypopituitarism, and confounding factors. These methodological issues prohibit simple generalizations of results of original studies on TBI-associated hypopituitarism in the perspective of meta-analyses or reviews.’ Kokshoorn et al (2010).

We do have to take informed decisions the best way to allocate our limited resources and I remain of the view that the best approach to this topic is a clinical guideline which addresses the question as to whether routine screening of patients following traumatic brain injury for pituitary dysfunction is clinically and cost effective.

Yours sincerely,

Andrew Dillon
Chief Executive


DOCUMENT 30
From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 23 June 2010 17:49
To: Fergus Macbeth
Cc: Alana Christopher; ottawayr@parliament.uk
Subject: CG56 update
Dear Dr Macbeth
When I enquired recently about the proposed new guideline about post-traumatic hypopituitarism, my attention was drawn to the minutes of the 15 March meeting of the Topic Selection Consideration Panel, Acute and Chronic Conditions.
The relevant passage reads:

6.8 Identification of late pituitary failure following head injury (3392)
This topic was introduced by Dr Colm Leonard. A significant percentage of patients develop pituitary abnormalities following traumatic brain injury. Pituitary abnormalities may arise quite some time after the injury. Specific endocrine testing is necessary to diagnose the problem. There is no known statistical racial predisposition in relation to traumatic brain injury (TBI). Children are particularly at risk due to growth hormone deficiency. This problem is under recognised and under diagnosed.
The Panel queried why this is not covered in Head injury (CG56). It was noted that the scope of the head injury guideline focuses on early management so this topic would not be included in any future update.
I was surprised to read this as you assured me in your letter of 11 June last year that "when the guideline is updated we will ensure that this issue is addressed". Ms Teresa Birch repeated this promise in her letter of 29 June with the words "As we've already stated, when the guideline is updated we will ensure that this issue is addressed." The scope of guideline CG56, which of course was defined many years ago, has in no way altered since this promise was made.
I would welcome your assurance that NICE is going to honour its promise to me. I have copied in Mr Richard Ottaway my MP into this correspondence as he is kindly taking an interest in this important health problem.
With kind regards
Joanna Lane
__________________________

DOCUMENT 31
From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 01 July 2010 20:27
To: Jane Cowl
Subject: updating of CG56 head injury

Dear Jane Cowl

I am writing to you in the hope that you canadvise me on what steps I can take to ensure that important and potentially life-saving information is included in the forthcoming update of the head injury guideline CG56. I understand an update is scheduled for this September.

I have been in correspondence with NICE for more than a year, since our son's suicide, urging that an exceptional update should be done, to include information on the high risk of hypopituitarism after traumatic brain injury. This information was omitted in both the 2003 and 2007 versions, even though research on this topic has been coming out since the 1980s and has increased dramatically since 2000.

Dr Macbeth refused to do an exceptional update but promised me that the matter would be addressed in the scheduled update, i.e. in September 2010. However I am now surprised and concerned to hear that the information will not be included even now. NICE is going through consultation on producing a separate guideline on the identification of hypopituitarism and claims that a separate guideline would make it unnecessary to include the information in the main guideline. They say that the scope of the main guideline covers only the acute stage.

I am very unhappy about this decision for the following reasons:
 pituitary dysfunction is important to recognize even in the acute stage. A deficiency of the hormone ACTH can be life-threatening in the acute stage and occurs in 12% of cases (Mr Dillon himself conceded this in an email to me)
 the scope of CG56 specifically states that "the guideline will provide criteria for the early identification of patients who would benefit from rehabilitation" (4.11 full guideline) and "the guideline will include ... secondary care with the aim of early detection of intracranial complications . . the aim is . . to arrange for appropriate diagnostic procedures and treatment." (6.18.3). Pituitary failure is an intracranial complication which requires diagnosis and treatment.
 The sample letter of discharge included in the guideline gives no warning, and is used verbatim by most hospitals. It is the patient's right to receive full information about the risks of his condition.
We are talking about a condition that can destroy a person's sexuality and fertility, causing impotence in men, loss of periods in women, depression, uncontrollable weight gain, failure to grow in children - and it is treatable.

An article last August highlighted the large numbers involved:
Given the large number of individuals who fall victim to TBI and SAH each year, post-traumatic hypopituitarism becomes an entity of major public health significance. Based on the incidence of patients hospitalized for TBI and SAH reported in the literature and the frequencies of hypopituitarism in these patients, the incidence of hypopituitarism caused by these disorders is estimated to be more than 30 per 100,000 per year. [1]
It is possibly the very size of the problem which is causing NICE's reluctance to open it up, given the current economic climate. But it is unethical to attempt to ease the NHS's financial problems by leaving a huge tranche of patients in the dark about their condition - which is what will happen if the discharge advice is left in its current state - and with no chance of fighting for their share of the available resources. And as I said before, it is a human right to be informed about one's condition, its risks and the treatment available.

Here is a link to a 2007 systematic review which covers more than 1000 patients and finds an incidence of 27.5% after traumatic brain injury and 47% after subarachnoid haemorrhage. www.ncbi.nlm.nih.gov/pubmed/17895459

I do hope you can help me in this very important matter.

With best wishes

Joanna Lane BA (Hons) Oxon



[1] Hypopituitarism and brain injury: recent advances in screening and management, Pickel J et al, F1000 Medicine Reports 2009, http://webcache.googleusercontent.com/search?q=cache:1LOB5-_Ni-0J:f1000medicine.com/reports/10.34





DOCUMENT 32

----- Original Message -----
From: NICE Mail
To: Joanna Lane
Sent: Wednesday, July 07, 2010 5:16 PM
Subject: RE: FW: CG56 update

Dear Ms Lane

Thank you for your email sent to Dr Macbeth on 23 June 2010 and your email sent to Jane Cowl on 1 July 2010.

Dr Macbeth has considered these emails and asked me to respond on behalf of NICE.

In your email to Dr Macbeth you refer to statements made in our letters to you dated 11 June and 29 June 2009. At the time of writing, we believed that the issues you raised would be covered when the head injury guideline (CG56) was considered for possible update. However, on further investigation, and as explained in our subsequent letters to you of 17 August, 9 October and 30 November 2009, we realised that the broader issue of post head injury hypopituitarism may not in fact be covered in a possible future update of the guideline because the existing scope of the head injury guideline (CG56) was to provide recommendations on the early management of head injury.

In acknowledgement of the fact that identification and management of pituitary failure following head injury may not fit within the scope of CG56 when we consider a review of the guideline and, in recognition of the possible importance of developing stand alone guidance on this topic, a suggestion to propose a new clinical guideline topic was made.

As you are aware from the topic selection minutes of 15 March 2010, the Acute and Chronic Conditions Consideration Panel suggested that a short clinical guideline on the identification of late pituitary failure following head injury, for both adults and children, providing advice on when to refer, what tests should be used and how often the tests should be performed, would be useful. Our Programme Manager for Topic Selection has explained the next step in the topic selection process and made you aware that there is no capacity within the short clinical guideline work programme to begin work on new topics at this present time. This does not mean that NICE will not produce guidance on this issue in the future. There is a possibility that the topic will be considered by the Referral Oversight Group (ROG) in September when capacity becomes available within the short clinical guideline programme.

As Andrew Dillon replied in his email to you in November, we are happy to keep you up to date with the progress of the proposed topic suggestion and I would ask you to contact me directly in respect of this.

In response to the additional points you raise in your email to Jane Cowl, as we have already explained previously, we are unable to continue to debate issues around updating the existing guideline or the intended scope.

Regards

Teresa

Teresa Birch
Communications Manager (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3134 | Fax: 44 (0)845 003 7785
Web: http://nice.org.uk

DOCUMENT 33

From: Joanna Lane
Received: 7/22/2010 10:29 AM
To: NICE Mail
Subject: Re: FW: CG56 update
Dear Teresa

Thank you for this response.

I now see that I did not read your letters last autumn carefully enough and I apologise. I thought that NICE's arguments about the scope were aimed at denying there was an error in CG56, and that the separate guideline was a substitute for the exception update I was asking for. I did not realise that the routine update would be completely silent about hypopituitarism.

Now that you have explained, however, I strongly feel that I cannot leave the matter as it is, for reasons that I explained in my email to Jane Cowl.

I know that NICE feels it has reached the point where it believes further communication on this topic is not fruitful. I too feel this and would now like to appeal directly to the Health Service Ombudsman.

However in his final reply to me, Mr Andrew Dillon made a point of saying that he was not treating my correspondence as a complaint, and this makes me wonder whether I should go through the motions of putting in a formal complaint and whether you should similarly go through the motions of turning it down before I approach the ombudsman, as I see that this is a requirement.

I would be grateful if you would clarify this for me.

With best wishes

Joanna


DOCUMENT 34
----- Original Message -----
From: Moya Alcock
To: 'Joannalane@blueyonder.co.uk'
Cc: NICE Mail
Sent: Thursday, August 19, 2010 3:16 PM
Subject: Re: FW: CG56 update

Dear Joanna,

Thank you for your email dated 22/7/10 sent to Teresa Birch in my team. Teresa is out of the office this week so I am responding on her behalf.

I appreciate that you remain unhappy and would like to take the issue further. With regards to your question about whether you need to submit a ‘formal’ complaint before taking your concerns to the Parliamentary and Health Services Ombudsman, I have discussed this with our Corporate Office who oversee our complaints process and we think that if you wish to take this further it would be appropriate for you now to go directly to the Parliamentary and Health Services Ombudsman as our complaints procedure does not cover complaints against our guidance.

My understanding is that the basis for your complaint is your unhappiness with our decision not to update CG56 in order to include guidance relating to the risk of hypopituitarism following brain injury. We have investigated and responded fully to your request and the concerns and questions you have raised with us about CG56 (responses sent to you on 28/11/08, 29/12/08, 27/02/09, 24/03/09, 15/04/09, 11/06/09, 29/06/09, 17/08/09). In addition, in response to the complaint you made on 11/09/09, our correspondence with you was reviewed by Alana Christopher, Associate Director - Corporate Office, (response sent to you on 9/10/09) and subsequently by Andrew Dillon, Chief Executive, (response sent to you on 30/11/09).

As you have already received a final response from us, and you still remain unhappy, it is appropriate to now take your concerns to the Parliamentary and Health Services Ombudsman at the address below.
The Parliamentary and Health Service Ombudsman
Millbank Tower
Millbank
London
SW1P 4QP
Tel: 0345 015 4033
Email: phso.enquiries@ombudsman.org.uk

Kind regards,

Moya Alcock
Associate Director (Enquiry Handling and Internal Communications)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3131 Fax: 44 (0)845 003 7785
Web: http://nice.org.uk


BUNDLE B – CORRESPONDENCE WITH NICE RE CG56


CONTENTS

Date        Document                   Page No

26.11.08 1: JL to Natalie Whelan 2
26.11.08 2: Natalie Whelan to JL 4
28.11.08 3: Natalie Whelan to JL 5
18.12.08 4: JL to Natalie Whelan 7
29.12.08 5: Natalie Whelan to JL 8
20.02.09 6: JL to Natalie Whelan 9
26.02.09 7: JL to Andrew Dillon 10
27.02.09 8: Natalie Whelan to JL 12
06.03.09 9. JL to Natalie Whelan 14
24.03.09 10: Teresa Birch to JL 15
24.03.09 11: JL to Teresa Birch 16
26.03.09 12a: JL to Teresa Birch 17
26.03.09 12b: JL to Teresa Birch 18
27.03.09 13: JL to Teresa Birch 19
15.04.09 14: Andrew Dillon to JL Ap 1
24.04.09 15: JL to Andrew Dillon 21
27.05.09 16: JL to Andrew Dillon 22
11.06.09 17: Fergus Macbeth to JL Ap 2
29.06.09 17a: Teresa Birch to JL 24
01.07.09 18: JL to Teresa Birch 25
19.07.09 19A: JL to Natalie Whelan 26
19.07.09 19b: JL summary FOI request 27
19.07.09 19c JL ‘omission causes harm to patients’ 29
17.07.09 20: Chris Thompson to JL Ap 3
30.07.09 21: JL to Fergus Macbeth 32
17.08.09 22a: Alana Christopher to JL 41
17.08.09 22b :FOI Docs 1,2,3,7,8,9,10,11,12,13,20,21,22,25 Aps 4-17
10.09.09 23: JL to Alana Christopher 48
09.10.09 24: Alana Christopher to JL 54
23.10.09 25: JL to Alana Christopher 56
30.10.09 26: JL to Andrew Dillon 58
30.11.09 27: Andrew Dillon to JL 60
07.01.10 28: JL to Andrew Dillon 62
11.01.10 29: Andrew Dillon to JL 63
19.08.10 30: Moya Alcock to JL 64
01.07.10 31: JL to Jane Cowl 65
19.08.10 32: Teresa Birch to JL 67
22.07.10 33: JL to Teresa Birch 68
19.08.10 34: Moya Alcock to JL 69
 

DOCUMENT 1

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 26 November 2008 13:59
To: Natalie Whelan
Subject: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

Thank you for listening to me just now!

I have patched in below an example of the recent research on hypopituitarism as a consequence of brain injury.You will see that 28% to 69% of brain injury survivors have pituitary damage.

As I was explaining to you, we think it's likely that our son's impotence (discovered by us after his death) was related to a severe head injury he had when he was seven. He would not consult a doctor about his ED, according to his ex-girlfriend, but he did seek help for his depression, and saw two GPs, a psychiatrist and two counsellors. None of them was aware of the research, so his history of TBI rang no bells. But if it had, they would have assessed his pituitary function and we understand he could have been treated successfully with testosterone patches.

We think it's vital to update your Guideline on Head Injury (CG56) to reflect this. In particular Appendices E, F and G, which give sample discharge advice cards, should include a warning that pituitary problems may become apparent years after the injury, in adolescence. And if it's impotence, the patient won't necessarily seek help.

I also think advice relating to depression and erectile dysfunction should point out that head injury can be a cause.

If you would like me to send you more research on the topic I'll be very glad to.

With best wishes

Joanna Lane

The effects of head trauma on hypothalamic-pituitary function in children and adolescents.
Endocrinology and metabolism
Current Opinion in Pediatrics. 19(4):465-470, August 2007.
Einaudi, Silvia; Bondone, Claudia
Abstract:
Purpose of review: Endocrine dysfunctions have been increasingly recognized following traumatic brain injury. Ever more numerous studies on acute head-injured adults have also raised concern about this risk in children and adolescents who have experienced head injury. The current review of the pediatric literature summarizes recent findings on acute-phase dysfunction and traumatic brain injury-associated hypopituitarism.
Recent findings: The pathophysiologic mechanisms underlying acute-phase hyponatremic and hypernatremic disorders have been elucidated. Prospective studies on traumatic brain injury-associated hypopituitarism in pediatric patients are ongoing and preliminary data are available.
Summary: Traumatic brain injury, a 'silent epidemic' (my emboldening) that carries a considerable burden of disabilities, leads to a variety of endocrine dysfunctions in 28-69% of adult acute head-injured patients. In the acute posttraumatic phase, adrenal insufficiency and electrolyte disorders are critical conditions. Neurosurgical patients, particularly those prone to neurological damage, require prompt diagnosis. Hypopituitarism may be diagnosed months or years after a traumatic brain injury event. Since growth hormone and gonadotropin secretion are most frequently compromised, careful follow-up of growth and pubertal development is mandatory in children hospitalized for traumatic brain injury.
(C) 2007 Lippincott Williams & Wilkins, Inc.



DOCUMENT 2

----- Original Message -----
From: Natalie Whelan
To: Joanna Lane
Sent: Wednesday, November 26, 2008 2:30 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

I just wanted to let you know that I have received your email – I will respond as soon as possible.

Regards,
Natalie

Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785

DOCUMENT 3

From: Natalie Whelan
To: Joanna Lane
Sent: Friday, November 28, 2008 3:26 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

Thank you for your comments and suggestions regarding the NICE Guideline on Head Injury (CG56) and damage pituitary function. I can appreciate that this is a very important issue for you, so I hope the following information can help provide you with an understanding of how NICE guidelines are amended after publication.

Following the publication of a clinical guideline, NICE and the NCC will not normally actively seek new evidence on an ongoing basis. However, the National Collaborating Centre (NCC) involved in producing the original guideline can ask NICE to review guidance earlier.

The guidance on the ‘Triage, assessment, investigation and early management of head injury in infants, children and adults’ was published in September 2007. There is no review date currently set for this guidance, although, usually, the NCC will undertake searches for new evidence and will make its recommendations about the need for and extent of an update, two years after the publication date. At this point, the quality of the new evidence will be considered, and it will be decided whether the guideline requires a complete, partial or no update. Four years after publication, the review process will be repeated.

In exceptional circumstances, significant new evidence may emerge that may necessitate an unscheduled partial update of a guideline. This might be one single piece of evidence, an accumulation of relevant pieces of evidence, or other published NICE guidance sufficient to make it likely that one or more recommendations in the guideline need changing in an important way. Examples of such evidence include randomised trial data, new diagnostic tests, changes in licensing or warnings issued by licensing agencies, or major changes in costs.

I have made your email available to the National Collaborating Centre for Acute Care, the NCC involved in producing the Head Injury guideline.

Please note that NICE have not yet been asked by the Department of Health to produce guidance on Erectile Dysfunction. However, the guidance on Depression is due to be reviewed in December 2008. Further details about this review (when available) will be listed via the following page: http://www.nice.org.uk/CG23

When a guideline is being reviewed, during the consultation period you will be able to submit your comments on the scope/recommendations, or you could do so via one of it’s registered stakeholder organisations (such as a patient/carer organisation – the names of stakeholder organisations will be listed on the particular guidance webpage).

I hope this information is helpful for you. Thank you for getting in touch with NICE.

Kind regards,
Natalie


Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785

DOCUMENT 4

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 18 December 2008 11:11
To: Natalie Whelan
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

Thank you so much for being so helpful on the phone back in November, and for passing on my email to the NCC involved in producing the Head Injury guideline.

Would it be possible for you now to find out if they do intend, as a result of my email, to do an unscheduled partial update? As you can see from the attached research, suicidal depression is far higher among TBI-survivors than the general population.

It seems so important to update the sample discharge letter, which makes no mention of the at least 25% risk of hypopituitarism. This would only be a matter of inserting the same few words into each of the Appendices E, F and G. If our son's letter of discharge had contained such a warning, it would have saved his life.

I hope you have a good Christmas.

Best wishes

Joanna



DOCUMENT 5

(From Natalie Whelan, Enquiry Handling, sent 29 December 2008 11.47)

Dear Joanna

I’ve looked into this for you and have been informed by the NCC that there are no plans to conduct an unscheduled review. However, this study will be kept on file and will be considered for inclusion when the guideline is next reviewed.

Kind regards,
Natalie


Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785

DOCUMENT 6

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 20 February 2009 16:03
To: Natalie Whelan
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

I hope you're well.

I thought you might be interested in reading an article by me published in today's Guardian.
http://www.guardian.co.uk/lifeandstyle/2009/feb/20/1

I have been thinking more about the need to update CG56 on head injury. In your email you explained that NICE updates fully every six years - 2 yrs after the guideline has come out NICE reviews the need to update, and then spends 4 years on the update itself. And you then said that as CG56 had been updated in 2007, nothing would happen for several years.

However when I recently revisited CG56 I noticed that the 2007 update is a partial update, which changes the picture completely. The last full update was in 2003 so CG56 is well due for revision.

What I would be very grateful if you would do for me, is find out exactly who it is who makes the decision on whether an update is necessary or not. I've rung the NCC who say NICE decides, and I've rung NICE and they say the NCC decides, and I now have emailed the Dept of Health who have said 'they aim to reply within 20 working days.'

But I feel you are sympathetic, and maybe with a few well-placed questions you could tell me who to approach, which is half the battle!

Thanks for helping me last time, and I hope you find the article interesting.

With all good wishes

Joanna



DOCUMENT 7

28 Southwood Avenue
Coulsdon, Surrey
CR5 2DT

Mr Andrew Dillon CBE, Chief Executive Officer
NICE
Mid City Place
71 High Holborn
London WC1V 6NA

26 February 2009

Dear Mr Dillon

Updating CG56 Head Injury Guideline

I am writing to ask if CG56 can be updated to include recent research on ‘hypopituitarism after traumatic brain injury’. Googling this topic currently brings up 44,300 links to a large body of peer-reviewed papers in the main medical journals.

The update is urgently needed because this condition affects one in five (conservatively) of moderate to severe head injury survivors, of which there are 21,000 a year in the UK. It can cause loss of libido, erectile dysfunction, amenorrhea, infertility and severely diminished quality of life. Many studies stress how under-diagnosed it is and estimate that most cases are never diagnosed at all.

Our particular reason for writing is that our 31-year-old son committed suicide last year, and we discovered afterwards that he was impotent. It is likely that this, and his depression, were caused by a severe head injury he had when he was seven.

Whether or not this is so, 1000s of head-injured people have been discharged from hospital in past decades without being screened for an unpleasant, sometimes life-threatening condition which they have a 20% chance of suffering from. This is terrible. It is hard to believe that research which has been coming out in such quantities since the year 2000 is still not reflected in hospital procedure.

Your organisation has told me that CG56 was updated in 2007 so there are no plans to update again. However I see that the 2007 version was a partial update covering only a few areas. The last full version came out in 2003 – so it is overdue for revision.

Please will you give this matter priority? I have written articles for Pulse, Mental Health Today, Therapy Today and the Guardian, and have had one accepted by the Telegraph. If you wish to read my Guardian article (Friday 20 Feb) the link is
http://www.guardian.co.uk/lifeandstyle/2009/feb/20/1

Yours sincerely



Joanna Lane




DOCUMENT 8

----- Original Message -----
From: Natalie Whelan
To: Joanna Lane
Sent: Friday, February 27, 2009 3:37 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

I appreciate you sending me the link to the Guardian article, thank you.

In your email you refer to the NICE updating clinical guidelines fully every six years, however, this isn’t correct. The Clinical Guidelines manual was updated at the start of this year. So instead of considering a review at 2 and 4 years, the procedure is to now consider an update every 3 years (at which point it may be decided that a partial or full update is required, or no update etc). The Head Injury update was published in Sept 2007 so the next consideration of an update will be next year (Sept 2010). Apologies for any confusion caused by my earlier response.

I hope the following points help to clarify the procedure in relation to updating clinical guidelines:

 NICE and the NCC will not actively seek new evidence on an ongoing basis, beyond collating post-publication comments, unless it has been identified in the guideline that important new information is likely to emerge before the 3-year scheduled review. In such instances, the NCC is responsible for alerting NICE to the new evidence and advising on the need for an exceptional update or amendment
 The NCC advises the Centre for Clinical Practice (CCP) at NICE about the need for, and extent of, an update 3 years after publication of a clinical guideline.
You can read more about this in Chapter 14 of the new Guidelines Manual, available at the following link: http://www.niceorg.uk/aboutnice/howwework/developingniceclinicalguidelines/clinicalguidelinedevelopmen tmethods/GuidelinesManual2009.jsp?domedia=1&mid=631D9427-19B9-E0B5-D482D5F402778A25
I have spoken to my colleagues at the NCC, who have explained that the research you had previously provided us with has been passed to the chair of the Guideline Development Group, and we await his comment.
I’m sorry it’s not possible to provide you with further information at this stage, but I shall be in contact again when I have an update for you.
Kind regards,
Natalie


Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3137 | Fax: 44 (0)845 003 7785





DOCUMENT 9

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 06 March 2009 15:53
To: Natalie Whelan
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Natalie

Thank you so much for all your trouble. The reference to Chapter 14 was helpful.

I do feel though that you've not quite answered my point that the 2007 update was only partial. Can a partial update have the status of a full one, and absolve NICE from doing a full update at the right interval of years from the last full update? This seems like saying that because you replaced your car tyres in August, you don't have to do anything when your annual service comes round in October!

With my best wishes, and thanks again for your help.

Joanna





DOCUMENT 10
----- Original Message -----
From: NICE Mail
To: joannalane@blueyonder.co.uk
Sent: Tuesday, March 24, 2009 4:09 PM
Subject: RE: Updating CG56 on head injury (hypopituitarism)

Dear Joanna

Thank you for your further email and I’m sorry for the delay in responding. Natalie has asked me to respond to your enquiry to provide some further clarification about our process for updating guidelines.

A partial update is still regarded as full and final NICE guidance and has the same status within the NHS as the original guideline. A partial update of the guideline was conducted in 2007 as only evidence relating to specific areas was identified as being significant enough to change part of the recommendations.

If you think about this in relation to a car‘s annual service When you take a car in, they would still perform a check on the tyres (even though they were replaced recently) but make a decision that they were still good for the road and didn’t actually need replacing at that time.

I understand that you have also sent a letter directly to Andrew Dillon about updating the guideline. Andrew has asked me to let you know that he will be replying to your letter soon.

Kind regards

Teresa

TB
Communications Manager (Enquiry Handling)
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


DOCUMENT 11

From Joanna Lane to Teresa Birch, sent 24 March 2009 18:24

Dear Teresa

All updates are partial, in the sense that they contain part of the old material. If they didn't they wouldn't be updates, they would be completely new documents.

The 2007 update was called 'partial' because only evidence relating to specific areas was looked at. If the NCC had been aware of the substantial body of research showing that one in four head injuries results in consequences as serious as impotence, infertility and suicidal depression, I am quite sure they would have regarded it as 'significant enough to change part of the recommendations.' But they didn't see it, and they didn't put it in.

They called it 'partial' to cover themselves from this kind of accusation. But I don't think they can have it both ways - 'partial' to cover themselves if people notice something that's been left out, but 'full' when they want to excuse themselves from doing a proper update at the correct time.

I hope I'm not putting this too strongly. You may be aware that our son committed suicide after suffering impotence and depression following a long-ago brain injury, so I can't help feeling an acute urgency to get this guideline updated properly.

My approach now to this issue will be that I shall withdraw from the argument, but hopefully put it into the hands of people who have more clout than I have. I am pre-recording an interview with Woman's Hour tomorrow when, if all goes well I believe Professor Chris Thompson, an eminent endocrinologist who has won the Servier Award in 2007 for his research into pituitary dysfunction after brain injury, will give his opinion on the steps that should be taken. I'll let you know when the programme is scheduled to go on air.

I am pleased to hear that Andrew Dillon will be replying to my letter, and I'd like to thank you for taking the trouble to reply to my email to Natalie.

With all good wishes

Joanna


DOCUMENT 12A

Sent by Joanna Lane to Teresa Birch, 26 March 2009, 09:28


Dear Teresa

Further to my last email I thought I would let you know that the Woman's Hour feature on head injury and pituitary dysfunction is being broadcast this morning. Unfortunately Professor Thompson wasn't able to take part, but Dr Tara Kearney of Salford Royal Hospital gave what seemed to me a comprehensive and clear account of the condition, and you might want to listen to it (it will be available on podcast on the BBC website afterwards).

With my best regards

Joanna




DOCUMENT 12B


Sent by Joanna Lane to Teresa Birch 26 March 2009 09:36

Dear Teresa

I should have mentioned that the interview with me is under the pseudonym Caroline Churchill.

Joanna


DOCUMENT 13

----- Original Message -----
From: Joanna Lane
To: NICE Mail
Sent: Friday, March 27, 2009 4:49 PM
Subject: Re: Updating CG56 on head injury (hypopituitarism)

Dear Teresa

Further to my last email, before I finally withdraw from the debate as I said I would, it would be a great help to me if you would define exactly what is meant by a full update of a guideline, and what differentiates it from a partial one.

We're away all next week so there is no hurry.

Once again, thank you for your help!

Kind regards

Joanna


DOCUMENT 14

This letter from Mr Andrew Dillon dated 15 April 2009 is a pdf document and given as Appendix 1.


DOCUMENT 15

28 Southwood Avenue
Coulsdon
CR5 2DT
Mr Andrew Dillon
Chief Executive
NICE
MidCity Place
71 High Holborn
London WC1V 6NA
Friday 24 April 2009
Dear Andrew Dillon

Updating CG56 Head Injury Guidelines

Thank you for explaining that partial updates have the same status as full ones. I accept that I have to abandon that line of argument. However, may I now try a different approach?

You say of the 2007 update that “only evidence relating to specific areas was identified as being significant enough to change part of the recommendations.” This implies that all the evidence was looked at, and the endocrine evidence was considered not “significant enough.” But a condition that occurs in 25% of cases and can cause death (see first bullet point below), impotence, infertility and suicidal depression is certainly not insignificant. It would surely be more accurate to say that because the 2007 guideline development group did not contain an endocrinologist, the abundant endocrine evidence was missed. In other words, it was an error.

Your Guidelines Manual says (14.6) that the identification of errors which may result in harm to patients may trigger an exceptional update.

CG56’s omission of all reference to hypopituitarism is exactly this – an error which may result in harm to patients – for the following reasons.
 A deficiency of ACTH is life-threatening in the acute stage.
 Patients must be screened for hypopituitarism at 3 months and a year after the injury if this notoriously under-diagnosed condition is to be picked up.
 CG56’s sample discharge letter does not warn that pituitary dysfunction may occur, possibly many years after the injury. So patients – and their parents – will not know of the risk of impotence, infertility and depression. This in itself may cause death, as we believe it did with our son.

I hope you will agree there is a case for an exceptional update of CG56.

Yours sincerely




Joanna Lane


DOCUMENT 16
28 Southwood Avenue
Coulsdon
CR5 2DT
Mr Andrew Dillon
Chief Executive
NICE
MidCity Place
71 High Holborn
London WC1V 6NA

27 May 2009
Dear Andrew Dillon

Updating CG56 Head Injury Guidelines

You may remember I wrote to you on 24 April asking whether you would consider an exceptional update to CG56 on the grounds that the present omission of reference to hypopituitarism is an error which may result in harm to patients.

If you have decided not to take this any further I shall understand, but it would be helpful if you could let me know one way or the other.

With many thanks.

Yours sincerely




Joanna Lane


DOCUMENT 17

This letter from Dr Fergus Macbeth dated 11 June 2009 is a pdf document and is given as Appendix 2.


DOCUMENT 17a

From: “NICE” nice@org.uk
To: joannalane@blueyonder.co.uk
Sent: 29 June 2009 12:40
Subject: RE: CG56

Dear Joanna

Dr. Fergus Macbeth has asked me to respond to your email on his behalf.

Unfortunately we are not at liberty to release the name of the author of the as yet unpublished research that Dr. Macbeth refers to, nor are we able to comment on the precise incidence of the condition in the report. As Dr. Macbeth stated in his letter, he believes that this research will be submitted for publication in due course.

Our discussion so far with experts has shown that there seems to be a difference in opinion about this issue and limited but contradictory evidence, but we are not able to change recommendations unless they are clearly supported by good quality evidence.

Because of your personal situation and interest in this subject one of the ways we feel you could help take this important issue forward is by helping to influence high quality research in this area. For more information bout research within the NHS, you may find the following website useful:

http://www.nihr.ac.uk/Pages/default.aspx

Dr. Macbeth has thoroughly investigated the points you have raised and confirmed that an immediate update is not justified. As we’ve already stated, when the guideline is updated we will ensure that this issue is addressed.

Unfortunately at this stage we are unable to help you any further.

Kind regards

Teresa

Teresa Birch
Communications Manager (Enquiry Handling)
National Institute for Health and Clinical Excellence



DOCUMENT 18
28 Southwood Avenue
Coulsdon
CR5 2DT

Ms Teresa Birch
Communications Manager (Enquiry Handling)
NICE
Level 1A City Tower Piccadilly Plaza
Manchester M1 4BD

1 July 2008


Dear Teresa

I thought I should formalise my request, under the Freedom of Information Act, that NICE disclose everything they have regarding the process they have gone through on the issue of doing an exceptional update on CG56.

I appreciate that you have told me that the information on hypopituitarism will be included when the guideline is updated, and this is good news.

However, last time the interval between beginning the update process on CG56 and the final publication was two years and a month. On this reckoning it will be October 2012 before the next update is produced.

On the basis that 150,000 head injuries occur annually, and 10%* of them will suffer pituitary dysfunction, that means around 45,000 people will have been needlessly left at risk in the 3 years between December 2008 when I first alerted NICE to their omission and the date they eventually remedy it. Interestingly only about 2,000 cases of hypopituitarism from all causes were diagnosed last year.

I consider this decision needs to be justified by NICE with the transparency that is one of its fundamental principles.

Yours sincerely




Joanna Lane

*My estimate is based on the most recent published research. I am open to persuasion that it is wrong, but would need to see the evidence.


DOCUMENT 19A

28 Southwood Avenue
Coulsdon
CR5 2DT

Ms Natalie Whelan
Communications Executive (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza
MANCHESTER M1 4BD

19 July 2009

Dear Natalie

As I said in my email to you of 19 July, I am enclosing two documents:

1) A summary of my Freedom of Information request 22123
2) A document arguing that NICE have a duty under their own rules to do an immediate update of CG56.

I look forward to hearing from you.

With many thanks

Yours sincerely





Joanna Lane


DOCUMENT 19B

SUMMARY OF FREEDOM OF INFORMATION REQUEST 22123

On 11 June Dr Fergus Macbeth wrote to me declining to do an immediate update on CG56 on the grounds that recent unpublished research had shown that there was a very much lower incidence of TBI-induced hypopituitarism than previously seen. He said “It’s important for us to target our resources in a way that gives the most benefit to the largest number of people.” I interpret this to mean that he had calculated the cost of an immediate update of CG56, and of the consequent diagnosis and treatment of patients with PTHP, and decided that this amount of money could benefit a larger number of people if spent in a different way.

In your publication SOCIAL VALUE JUDGEMENTS the following paragraph occurs under the heading Regulation:

It is particularly important for NICE to be ‘accountable for its reasonableness’ because it provides advice to the NHS. The NHS is funded from general taxation, and it is right that UK citizens have the opportunity to be involved in the decisions about how the NHS’s limited resources should be allocated.

I would like to see Dr Ferguson’s cost-benefit analysis
I am emboldened by the words quoted above to ask, as a tax-paying UK citizen, to see the cost-benefit analysis whereby Dr Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism so that it would not be published until (as we estimate) October 2012. During the delay I estimate that between 30,000 and 45,000 head injury patients will remain undiagnosed of a condition that seriously affects their quality of life. Many may suffer broken marriages and relationships as a result. Some may commit suicide.

Incidentally I understand that in general interventions with an ICER of less than £20,000 per QALY gained are considered to be cost-effective and I would imagine this would apply here.

I would like to see all documents generated by my April letter to Mr Dillon
I would like to see all the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June. This would include any notes resulting from his telephone conversation with the unnamed endocrinologist.

A question about your procedural principles
I understand from the section on ‘Procedural principles’ in Social Value Judgements that NICE would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. I would like to know what these exceptional circumstances are. I would also ask under what FOI exemption you are withholding this unpublished research from me.

On what grounds can NICE justify not warning patients of the risks they face?
Furthermore (with reference to the principle of ‘respect for autonomy’ described in the same document) I would like to know on what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time. If individuals have a right ‘to make informed choices about healthcare . . .and health protection’ it is crucial that they are given information about the risks they face.

I understand that I can expect to wait for 20 working days before I receive an answer to this FOI request.

Thank you very much for your help on this matter.
19 July 2009
Joanna Lane


DOCUMENT 19C

The omission to mention hypopituitarism in CG56 was an error which may result in harm to patients

May I first draw attention to the title of CG56, Triage, assessment, investigation and early management of head injury in infants, children and adults noting in particular the words ‘assessment’ and ‘investigation.’ I would then like to review the process whereby the guideline was developed.

1. The scope clearly envisaged complications such as hypopituitarism
The original Scope document for CG56 (unchanged apparently since 2001) has a paragraph on ‘Clinical Need and Practice’ which contains the statement:

Most [head injury] patients recover without specific or specialist intervention but in others, persistent disability or even death results from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment. Much of the controversy and uncertainty in the early care of head injured patients is focused upon how these patients are best managed.

I need not labour the point that pituitary dysfunction is a complication that can result in persistent disability or even death. Dr Macbeth’s own words in his letter to me were “I am not denying the seriousness of this condition and the scope for a disastrous outcome if not recognised.”

2. The scope intended that the guideline should ensure such complications were detected
The scope document says ‘The guideline will not address the rehabilitation or longterm care of patients with head injury but the guideline will provide criteria for the early identification of patients who would benefit from rehabilitation. It continues that the guideline will include

information for patients and carers, and advice to primary care on the management of patients who re-present with suspicious symptoms, and guidance for appropriate handover arrangements.

One of the three published versions of the guideline will be “designed to help patients and carers to make informed choices about their care.” (my italics)

3. The published research about hypopituitarism should have been found during the Scoping Search
During the Scoping Search phase, the Information Specialist of the Guideline Development Group had the responsibility of identifying the key clinical issues for inclusion. Medline is specifically given as a suggested source (see Guidelines Manual) and the most cursory search of Medline under ‘traumatic brain injury’ would have brought up many studies, ranging from an overview from as long ago as 1991 (Neuroendocrine Abnormalities in Patients with Traumatic Brain Injury, Yuan Wade) to the important 2005 paper Hypopituitarism following Traumatic Brain Injury – Call for Attention, by Popovic, Aimaretti, Casanueva, Ghigo.

Sadly, the Information Specialist failed to carry out this minimal search. Clearly his performance in this case severely compromised NICE’s quality assurance procedures.

4. The omission of hypopituitarism from CG56 satisfies two of the criteria of an ‘error’
To be considered an error, only one of the three criteria listed in 14.6.1 in your guidelines manual needs to be satisfied. Here they are:

Corrections or changes to a published clinical guideline will be made if an error
 May result in harm to patients
 Undermines the conclusions on which the recommendations have been based
 Indicates the NICE’s quality-assurance procedures have been seriously compromised

I consider that the first and third criteria are satisfied. (As regards patient safety, clearly, failing to diagnose a patient with hypopituitarism results in harm to him/her.)

I also consider the failure to include a warning in the sample discharge letter breaches NICE’s fundamental principle of respect for autonomy – the right of the patient to make ‘an informed choice’ about healthcare, which is mentioned in the Scope document. If he suffers depression or sexual dysfunction he will hardly refer himself to an endocrinologist unless he is warned that PTHP can cause these symptoms.

5. If an error is identified NICE has only two options – to deny or to correct
As I understand section 14.6.1, if an error is reported, Dr Macbeth and the NCC have to consider the suspected error. It seems there are then two options. Either Dr Macbeth decides there is no error and writes to me explaining the rationale for his decision. Or there is an error, in which case the error is corrected. There is no middle way.

6. Dr Macbeth has not informed me that there is no error
Dr Macbeth has not told me there is no error. On the contrary, as I have said, he does not ‘deny the scope for a disastrous outcome’ if hypopituitarism is not diagnosed. He promises that the matter will be addressed in the revised guideline when it comes out (I believe in autumn 2012). He clearly accepts that the guideline should contain this vital information.

7. If there is an error, NICE has an immediate obligation to correct it
The NICE Guidelines Manual gives no provision for postponing a correction for three years. If even only one patient might suffer harm as a result of their error there would be an obligation to put it right straight away. In fact, of course, in those three years it is likely that 30,000-45,000 patients will remain undiagnosed with PTHP. It is hard to see how anything can justify this.

In short, I believe NICE should correct CG56 without any further discussion.

Joanna Lane 19 July 2009



DOCUMENT 20

This letter from Professor Chris Thompson of Beaumont Hospital in Dublin dated 17 July 2009 is a pdf document and given in the Appendix.


DOCUMENT 21

28 Southwood Avenue
Coulsdon
CR5 2DT

Dr Fergus Macbeth
NICE
MidCity Place
71 High Holborn
LONDON
WC1V 6NA

30 July 2009

Dear Dr Macbeth

Updating CG56 Head Injury Guidelines

Thank you for your letter of 11 June informing me that in the light of unpublished research that shows ‘a very much lower incidence than previously seen,’ NICE does not feel an immediate update is justified. I have some points to make in reply which I will arrange under headings for clarity:-

The incidence is not diminished by this new research
I confess I could not see how one unpublished paper could negate the vast body of published research over the past ten years indicating that 25% of survivors of moderate/severe TBI have pituitary damage. I now find my disbelief was justified. An endocrinologist who is too eminent in the PTHP field to be mistaken, has written to me that ‘the vast majority of the published papers suggest figures of 20% to 30%’ and that a lower figure is ‘incorrect.’ I can only suppose that your new figure applies to all head injuries including mild, and there has been a misunderstanding. Clearly 10% of all head injury cases (of which there are 150,000 annually) comes to a larger number of people than 20-30% of mod/severe cases (of which there are only 21,000 annually).

Therefore I do not accept your rationale for not updating immediately. However I think you will see from my next point that the incidence figure is not the main issue, since NICE has a duty to correct the guideline regardless of the number of people affected.

There is a duty to correct immediately an error which may cause harm to patients and which severely compromises NICE’s Quality Assurance Procedures
I do not understand how the Information Specialist who conducted the Scoping Search for the 2007 update (and indeed the original 2003 version) managed to miss the mass of literature relating to PTHP but clearly the NICE’s quality assurance procedures have been severely compromised, while the harm that may be caused to patients by the omission hardly needs spelling out. I argue this point more fully in Attachment A which I have already emailed to Teresa Birch. When there is an error, your own rules allow only two options – NICE must deny the error exists and justify that denial, or to correct it immediately.

FOI request
I should say here that I have asked to see the cost-benefit calculation which justifies leaving around 45,000 head injury survivors needlessly undiagnosed with PTHP for the three years until the new guideline is published (Attachment B). We are talking about a condition which as you know can wreck relationships and lead to suicide. I understand that £20,000 per QALY is generally considered cost-effective and would be very surprised if the expense of updating the guideline, screening head injury patients and treating them, came to more than this, bearing in mind that someone like our son could have had 60 years of good quality life if diagnosed when symptoms began.

An MP is willing to ask a question in Parliament
Last month I was lucky enough to meet an MP whose particular concern is mental health, and when I described the PTHP problem she kindly expressed herself willing to ask a question in the House. At the time I believed that NICE’s own procedures would ensure the right outcome and her intervention would be unnecessary, and I still hope that this will be the case. However, if I do not receive confirmation of this by the 26 August (the anniversary of our dear son’s death, so an appropriate date) I believe my best option will be to approach her again.

Yours sincerely




Joanna Lane

Attached:
1. Attachment A: ‘The omission to mention hypopituitarism in CG56 was an error which may result in harm to patients’
2. Attachment B – summary of FOI request
3. Attachment C - List of PTHP literature

Copies to:
Mr Andrew Dillon, Chief Executive Officer, NICE
NICE, MidCity Place, 71 High Holborn, London WC1V 6NA

Ms Teresa Birch, Communications Officer, NICE
Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BD


Attachment A
The omission to mention hypopituitarism in CG56 was an error which may result in harm to patients

May I first draw attention to the title of CG56, Triage, assessment, investigation and early management of head injury in infants, children and adults noting in particular the words ‘assessment’ and ‘investigation.’ I would then like to review the process whereby the guideline was developed.

1. The scope clearly envisaged complications such as hypopituitarism
The original Scope document for CG56 (unchanged apparently since 2001) has a paragraph on ‘Clinical Need and Practice’ which contains the statement:

Most [head injury] patients recover without specific or specialist intervention but in others, persistent disability or even death results from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment. Much of the controversy and uncertainty in the early care of head injured patients is focused upon how these patients are best managed.

I need not labour the point that pituitary dysfunction is a complication that can result in persistent disability or even death. Dr Macbeth’s own words in his letter to me were “I am not denying the seriousness of this condition and the scope for a disastrous outcome if not recognised.”

2. The scope intended that the guideline should ensure such complications were detected
The scope document says ‘The guideline will not address the rehabilitation or longterm care of patients with head injury but the guideline will provide criteria for the early identification of patients who would benefit from rehabilitation. It continues that the guideline will include

information for patients and carers, and advice to primary care on the management of patients who re-present with suspicious symptoms, and guidance for appropriate handover arrangements.

One of the three published versions of the guideline will be “designed to help patients and carers to make informed choices about their care.” (my italics)

3. The published research about hypopituitarism should have been found during the Scoping Search
During the Scoping Search phase, the Information Specialist of the Guideline Development Group had the responsibility of identifying the key clinical issues for inclusion. Medline is specifically given as a suggested source (see Guidelines Manual) and the most cursory search of Medline under ‘traumatic brain injury’ would have brought up many studies, ranging from an overview from as long ago as 1991 (Neuroendocrine Abnormalities in Patients with Traumatic Brain Injury, Yuan Wade) to the important 2005 paper Hypopituitarism following Traumatic Brain Injury – Call for Attention, by Popovic, Aimaretti, Casanueva, Ghigo.

Sadly, the Information Specialist failed to carry out this minimal search. Clearly his performance in this case severely compromised NICE’s quality assurance procedures.

4. The omission of hypopituitarism from CG56 satisfies two of the criteria of an ‘error’
To be considered an error, only one of the three criteria listed in 14.6.1 in your guidelines manual needs to be satisfied. Here they are:

Corrections or changes to a published clinical guideline will be made if an error
 May result in harm to patients
 Undermines the conclusions on which the recommendations have been based
 Indicates the NICE’s quality-assurance procedures have been seriously compromised

I consider that the first and third criteria are satisfied. (As regards patient safety, clearly, failing to diagnose a patient with hypopituitarism results in harm to him/her.)

I also consider the failure to include a warning in the sample discharge letter breaches NICE’s fundamental principle of respect for autonomy – the right of the patient to make ‘an informed choice’ about healthcare, which is mentioned in the Scope document. If he suffers depression or sexual dysfunction he will hardly refer himself to an endocrinologist unless he is warned that PTHP can cause these symptoms.

5. If an error is identified NICE has only two options – to deny or to correct
As I understand section 14.6.1, if an error is reported, Dr Macbeth and the NCC have to consider the suspected error. It seems there are then two options. Either Dr Macbeth decides there is no error and writes to me explaining the rationale for his decision. Or there is an error, in which case the error is corrected. There is no middle way.

6. Dr Macbeth has not informed me that there is no error
Dr Macbeth has not told me there is no error. On the contrary, as I have said, he does not ‘deny the scope for a disastrous outcome’ if hypopituitarism is not diagnosed. He promises that the matter will be addressed in the revised guideline when it comes out (I believe in autumn 2012). He clearly accepts that the guideline should contain this vital information.

7. If there is an error, NICE has an immediate obligation to correct it
The NICE Guidelines Manual gives no provision for postponing a correction for three years. If even only one patient might suffer harm as a result of their error there would be an obligation to put it right straight away. In fact, of course, in those three years it is likely that 30,000-45,000 patients will remain undiagnosed with PTHP. It is hard to see how anything can justify this.

In short, I believe NICE should correct CG56 without any further discussion.

Joanna Lane 19 July 2009

Attachment B
SUMMARY OF FREEDOM OF INFORMATION REQUEST 22123

On 11 June Dr Fergus Macbeth wrote to me declining to do an immediate update on CG56 on the grounds that recent unpublished research had shown that there was a very much lower incidence of TBI-induced hypopituitarism than previously seen. He said “It’s important for us to target our resources in a way that gives the most benefit to the largest number of people.” I interpret this to mean that he had calculated the cost of an immediate update of CG56, and of the consequent diagnosis and treatment of patients with PTHP, and decided that this amount of money could benefit a larger number of people if spent in a different way.

In your publication SOCIAL VALUE JUDGEMENTS the following paragraph occurs under the heading Regulation:

It is particularly important for NICE to be ‘accountable for its reasonableness’ because it provides advice to the NHS. The NHS is funded from general taxation, and it is right that UK citizens have the opportunity to be involved in the decisions about how the NHS’s limited resources should be allocated.

I would like to see Dr Ferguson’s cost-benefit analysis
I am emboldened by the words quoted above to ask, as a tax-paying UK citizen, to see the cost-benefit analysis whereby Dr Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism so that it would not be published until (as we estimate) October 2012. During the delay I estimate that between 30,000 and 45,000 head injury patients will remain undiagnosed of a condition that seriously affects their quality of life. Many may suffer broken marriages and relationships as a result. Some may commit suicide.

Incidentally I understand that in general interventions with an ICER of less than £20,000 per QALY gained are considered to be cost-effective and I would imagine this would apply here.

I would like to see all documents generated by my April letter to Mr Dillon
I would like to see all the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June. This would include any notes resulting from his telephone conversation with the unnamed endocrinologist.

A question about your procedural principles
I understand from the section on ‘Procedural principles’ in Social Value Judgements that NICE would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. I would like to know what these exceptional circumstances are. I would also ask under what FOI exemption you are withholding this unpublished research from me.

On what grounds can NICE justify not warning patients of the risks they face?
Furthermore (with reference to the principle of ‘respect for autonomy’ described in the same document) I would like to know on what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time. If individuals have a right ‘to make informed choices about healthcare . . .and health protection’ it is crucial that they are given information about the risks they face.

I understand that I can expect to wait for 20 working days before I receive an answer to this FOI request.

Thank you very much for your help on this matter.
19 July 2009
Joanna Lane

Attachment C
Research relating to hypopituitarism after traumatic brain injury

Introductory note:
This does not pretend to be a comprehensive list of all the available literature, but is merely a record of the papers I have read in abstract. The vast majority of these papers suggest an incidence of 20-30% of hypopituitarism after traumatic brain injury. The studies are listed in reverse chronological order by publication year.

Pituitary and hypothalamic dysfunction after traumatic brain injury, Max Planck Institute of Psychiatry, 2009

Neuroendocrine disorders after traumatic brain injury, LA Behan, J Phillips, C J Thompson, A Agha, J. Neurol. Neurosurg. Psychiatry 2008; 79; 753-759.

Neuroendocrine consequences of traumatic brain injury, Acerini, Tasker, Pediatr Endocrinol Metab, 2008

Head-injury-induced pituitary dysfunction. An old curiosity rediscovered, Acerini C, Archives of Disease in Childhood 2008

Pituitary function in paediatric survivors of severe traumatic brain injury, P Poomthavorn, W Maixner, M Zacharin, Archives of Disease in Childhood 2008; 93;133-137.

Pathophysiology of hypopituitarism in the setting of brain injury, Dusick, Wang, Cohan, Swerdioff, Kelly, Pituitary 2008

Assessment of traumatic brain injury and anterior pituitary dysfunction in adolescents, De Sanctis, Sprocati, Govoni, Raiola, Georgian Med News 2008

Chronic hypopituitarism after traumatic brain injury: risk assessment and relationship to outcome, Bavisetty et al, Neurosurgery, 2008

Does the type and severity of brain injury predict hypothalamo-pituitary dysfunction? Does post-traumatic hypopituitarism predict worse outcome? Klose, Feldt-Rasmussen, Pituitary 2008

Is hypopituitarism predictable after traumatic brain injury? Liew, Thompson, Nature Clinical Practice Endocrinology & Metabolism 2008

The effects of head trauma on hypothalamic-pituitary function in children and adolescents. S Einaudi, C Bondone, Current Opinion in Pediatrics. 19(4):465-470, August 2007.

Hypopituitarism following traumatic brain injury, Agha, Phillips, Thompson, British Journal of Neurosurgery, 2007

Acute and long-term pituitary insufficiency in traumatic brain injury: a prospective single-centre study, Klose, Juul et al, Clin Endocrinol (Oxf) 2007
(study includes mild TBI)

A prospective longitudinal study of anterior pituitary dysfunction following traumatic brain injury, Kleindienst et al, Endocrine Abstracts 2007

The Neuroendocrine Effects of Traumatic Brain Injury, Rothman et al, J Neuropsychiatry Clin Neurosci, 2007

Evolving hypopituitarism as a consequence of traumatic brain injury (TBI) in childhood – call for attention, 2007, M -Medic-Stojanoska, S Pekic, N Curic, D Djilas-Ivanovic and V Popovic, Endocrine.

The effects of head trauma on hypothalamic-pituitary function in children and adolescents, Einaudi, Bondone Curr Opin Pediatr 2007

Managing patients with hypopituitarism after traumatic brain injury, Corneli, Ghigo, Aimaretti, Curr Opin Endocrinol Diabetes Obes, 2007

Hypothalamopituitary dysfunction following traumatic brain injury and aneurismal subarachnoid hemorrhage: a systematic review, Schneider, Kreitschmann-Andermahr, Ghigo, Stalla, Agha, JAMA 2007

Abnormalities of Pituitary Function after Traumatic Brain Injury in Children, Niederland etc al, Horm. Res. 2007

Traumatic Brain Injury-Induced Hypopituitarism in adolescence, R Baldelli, S Bellone, G Corneli, S Savastio, A Petri and G Bona Official Journal of the Pituitary Society, 2006

Traumatic Brain Injury Induced Hypopituitarism: The Need and Hope of Rehabilitation, Brent E Masel, Pituitary, 2006

Screening for Hypopituitarism Following Traumatic Brain Injury, Aimaretti et al, 2006, Minimally Invasive Neurosurgery and Multidisciplinary Neurotraumatology (book)

Hypopituitarism in childhood and adolescence following traumatic brain injury: the case for prospective endocrine investigation. Eur J Endocrinol. 2006;155;663-9.

Anterior pituitary hormone dysfunction after traumatic brain injury: less common than previously thought? Karavitaki et al Endocrine Abstracts 2006
(‘provides findings which are at odds with all of the other published literature’ according to eminent endocrinologist)

Prevalence of anterior pituitary insufficiency 2 and 12 months after traumatic brain injury, Schneider H J et al, European Journal of endocrinology/European Fed of Endocrine Societies, 2006

High Risk of Hypopituitarism after Traumatic Brain Injury: A prospective investigation of anterior pituitary function in the acute phase and 12 months after trauma, Tanriverdi et al, Journal of clinical Endocrinology & Metabolism, 2005

Consensus guidelines on screening for hypopituitarism following traumatic brain injury, Ghigo, Masel et al, Brain Inj. 2005

Epidemiology of Traumatic Brain Injury and Subarachnoid Hemorrhage, Leon-Carrion et al, Pituitary 2005

Variations of pituitary function over time after brain injuries: the lesson from a prospective study, Giordano, Aimaretti, Ghigo, Pituitary 2005

Anterior Pituitary Hormone Abnormalities following Traumatic Brain Injury, Schneider et al, Journal of Neurotrauma 2005

Anterior hypopituitarism following traumatic brain injury, Urban, Harris, Masel, Brain Injury Vol 19 2005

Brain Injury and Pituitary Dysfunction, 2005, Lisa B Nachtigall, Massachusetts General Hospital Neuroendocrine Clinical Center Bulletin

Hypopituitarism after traumatic brain injury, 2005, Bondanelli et al, European Journal of Endocrinology

Delay in diagnosis of Hypopituitarism after Traumatic Brain Injury, Aug 2005, Neuro Endocrinology Lett

High risk of hypogonadism after traumatic brain injury: clinical implications, Agha, Thompson, Pituitary, 2005

Traumatic brain injury and hypopituitarism, Aimaretti et al, TheScientificWorldJournal, 2005

Anterior Pituitary Dysfunction in Survivors of Traumatic Brain Injury, Agha et al, Journal of Clinical Endocrinology & Metabolism 2004

Neuroendocrine abnormalities in patients with traumatic brain injury, Yuan, Wade, Front. Neuroendocrinol. 1991

Hypopituitarism Secondary to Head Trauma, 1985, Benvenga et al, Journal of Clinical Endocrinology and Metabolism.

 

DOCUMENT 22a

From Teresa Birch to Joanna Lane sent 17 August 2009 15:48.

Dear Ms Lane,

FREEDOM OF INFORMATION ACT 2000: REFERENCE 22123

Thank you for your request for information, received at this office on 20 July 2009, in which you requested details of the following:

a) a) The cost-benefit analysis whereby Dr Fergus Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism.

b) b) All the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June.

c) c) In the Social Value Judgements document, NICE states it would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. What are these exceptional circumstances? Which FOI exemption is NICE relying on to withhold the senior endocrinologist’s unpublished research

d) d) On what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time.

I have set out the Institute’s response to your FOI request, and accompanying letter, below.

The cost-benefit analysis whereby Dr Fergus Macbeth reached his decision to postpone the inclusion of the information about the risk of hypopituitarism.

NICE do not produce a cost-benefit analysis as part of our standard process for updating guidelines. Therefore, under the Freedom of Information Act 2000, we are unable to provide this for you as we do not hold this information.

When deciding whether to carry out a scheduled or unscheduled update of a guideline many factors are taken into account, but the direct cost of updating the guideline is not a criterion for decision.

It is incorrect to attribute the reference of ‘targeting our resources in a way that gives the most benefit to the largest number of people’ to the direct cost of producing an immediate update of the Head Injury guideline. This statement was intended to reflect the wider issues we face in our role as a guideline producer.
All the documents internal and external to NICE generated by my letter to Mr Andrew Dillon in April when I made the point that there was an error in CG56 which would result in harm to patients, up until Dr Macbeth’s letter of 11 June.

We have identified 26 documents for the period 29 April 2009 to 11 June 2009 which fall within the scope of this request.

The 14 documents we are disclosing are named: Doc 1, 2, 3, 7, 8, 9, 10, 11, 12, 13, 20, 21, 22 & 25. They are enclosed with this letter.

Personal data has been redacted in all documents where its disclosure is exempt under Section 40(2) of the Freedom of Information Act as it would contravene the Data Protection Act 1998. The details of all NICE staff below Senior Management Team level have been redacted.

In addition, data has been redacted in Doc 9 because it is exempt under Section 22, as the information is intended for future publication.

Documents 4, 5, 6, 14, 15, 16, 17, 18, 19, 23, 24 & 26 have not been disclosed as they contain information exempt from disclosure under Section 21 of the Act, as the information is reasonably accessible to the applicant by other means. For example, because the information has been provided by, or already sent to, the correspondent, or the information is repeated within the above disclosed documents.

In the Social Value Judgements document, NICE states it would normally rely on a systematic review of the relevant published literature and that ‘only in exceptional circumstances does NICE accept unpublished evidence’. What are these exceptional circumstances? Which FOI exemption is NICE relying on to withhold the senior endocrinologist’s unpublished research

Under the Freedom of Information Act, NICE is only obliged to release information to you if we hold the information.

The research referred to in Dr Fergus Macbeth’s letter of 11 June relates to a study which will be published at a later date. We hold no other information about this unpublished research.
As this research study is unpublished, the details discussed in Doc 9 are exempt from disclosure under s.22 of the Freedom of Information Act, as it is information that is intended for publication at a future date.

The Social Value Judgements document that you refer to describes the principles that NICE should follow in designing the processes it uses to develop its guidance, and in developing individual pieces of guidance.
The statement you have referred to from the document is taken out of context as it reads in full, ‘Only in exceptional circumstances does NICE accept unpublished evidence that must remain ‘confidential’ to protect the commercial or academic interests of a company or organisation.’

The statement above does not mean that NICE only accepts unpublished evidence in exceptional circumstances. It refers to a stage in our standard guideline development process which is explained in more detail below.

When we identify the evidence during guideline development, the Guideline Development Group (GDG) and National Collaborating Centre (NCC) staff may have good reason to believe that information exists that has not been found using standard searches. In these situations, the NCC may call for evidence from all registered stakeholders.

Stakeholders may submit relevant unpublished data or studies in response to a call for evidence, in addition to published studies. When the NCC sends out a call for evidence, it asks stakeholders that respond to complete a checklist that lists and identifies the location of all confidential information contained in their submission.

You can read more about the process we follow for identifying evidence in Chapter 5 of our guidelines manual.

We do not have set criteria for deciding in what circumstances we would accept unpublished evidence that must remain confidential because, due to the broad nature of evidence, this decision would need to be made on a case-by-case basis.

On what grounds NICE can justify not updating immediately the sample letter of discharge in CG56 so that it warns patients of the danger that hypopituitarism may affect them after an interval of time.

The suggested written discharge advice was produced in line with the scope which specifically addresses ‘the management at home of patients who are discharged within 48 hours of admission’.

Its purpose is to provide suggested advice to the NHS about what advice they should provide for patients and carers when discharging patients who have sustained a head injury within 48 hours.

Advice is given on long-term problems in the suggested written discharge letter. It states that

‘Most people recover quickly from their accident and experience no long-term problems. However, some people only develop problems after a few weeks or months. If you start to feel that things are not quite right (for example, memory problems, not feeling yourself), then please contact your doctor as soon as possible so that he or she can check to make sure you are recovering properly.’

It is not appropriate for us to update this document to warn about the possible danger of hypopituitarism as this does not reflect the original guideline scope, or the evidence that was considered during the development of the guideline.
The response time for your FOI request on this occasion was 20 working days.
If you are unhappy with the response to your Freedom of Information request and wish to make a formal complaint it must be made in writing by letter, fax or email within 20 working days of the Institute’s response to you and sent to:

Alana Christopher
Associate Director, Corporate Office
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London WC1V 6NA
Email: Alana.christopher@nice.org.uk

Once we have received your complaint, you will be sent an acknowledgement within two working days. The Associate Director, Corporate Office, will review your complaint and a full reply will be sent to you within 20 working days.

If you are not content with the outcome your complaint, you may apply directly to the Information Commissioner for a decision who can be contacted at: The Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.


When you originally approached NICE in November 2008, the Enquiry Handling Team referred your enquiry onto the National Collaborating Centre for them to consider whether the issues you raised warranted an exceptional update of the guideline. As you are aware Dr Fergus Macbeth also sought an independent opinion in addition to our usual process.

In investigating the issues you raised, we have moved away from focusing on the intended scope of the guideline which was ‘to provide recommendations on the early management of head injury.’

It is unfortunate that we did not explore the intended scope of the guideline with you in our earlier conversations but I hope the answers below help to explain and address the additional points in your accompanying letter.

1. The scope clearly envisaged complications such as hypopituitarism
2. The scope intended that the guideline should ensure such complications were detected

The referral received by the Department of Health and National Assembly for Wales asked NICE to provide guidance to A & E departments about:

 which patients can go home without admission to hospital,
 which patients with a relatively minor injury require admission to a hospital for a short period, i.e. not more than 48 hours,
 which patients require transfer to a neurosurgical unit and may require neurosurgery,
 after discussion with neurosurgeons, which severely head-injured patients do not require neurosurgical intervention but do require admission to a neuroscience unit,
 which accompanying injuries require the involvement of other specialities.

The intended focus of the guideline was to provide recommendations on the early management of head injury. Addressing the long-term management of head injured patients was outside of the scope of this particular guideline.

3. The published research about hypopituitarism should have been found during the scoping search

The scoping search is carried out after review questions have been developed and is designed to address all areas covered by the scope. Review questions are refined and agreed by all GDG members through discussions at GDG meetings. The different perspectives among GDG members ensures that the right review questions are identified, thus enabling the literature search to be planned efficiently.

The key clinical questions developed for this update were:

1 In deciding on the most appropriate destination for a patient with severe head injury, what are the benefits of direct transport to a specialist neurosciences centre compared to transport to the nearest district general hospital?
2 For patients who have suffered a clinically important brain injury that does not require surgical intervention and who have been transported to a non specialist centre, what are the benefits of the patient continuing on receiving treatment at that district general hospital versus being transferred to a neurosciences centre?
3 What is the best initial diagnostic technique to determine which patients have sustained damage to the head and require further assessment of the head?
4 What is the best clinical prediction rule for selecting patients with head injury for the imaging technique selected in question 3?
5 What is the best diagnostic technique to determine which patients have sustained damage to the cervical spine and require further assessment of cervical spine?
6 What are the best clinical prediction rule(s) for selecting patients that have sustained damage to the cervical spine for the imaging technique selected in question 5?
7 What is the harm associated with radiation to the head and/or spine?
8 Which is the best tool for identifying the patients who should be referred to rehabilitation services following the initial management of a head injury?

The scoping search did not focus on identifying studies relating to hypopituitarism as this did not address the review questions above.

The search strategies used in the development of this guideline are included with this letter.

4. The omission of hypopituitarism from CG56 satisfies two of the criteria of an ‘error’
5. If an error is identified NICE has only two options – to deny or to correct
6. Dr Macbeth has not informed me that there is no error
7. If there is an error, NICE has an immediate obligation to correct it

We do not consider that the omission of hypopituitarism from the Head Injury guideline is an error as our remit was to produce a guideline that focused on the triage, assessment, investigation and early management in infants, children and adults.

As you are already aware NICE and the NCC will not actively seek new evidence on an ongoing basis, beyond collating post-publication comments, unless it has been identified in the guideline that important new information is likely to emerge before the 3-year scheduled review. In such instances, the NCC is responsible for alerting NICE to the new evidence and advising on the need for an exceptional update or amendment.
Both the NCC and Dr Macbeth have considered the points you have raised since November 2008. Both have advised that the omission of hypopituitarism does not warrant an unscheduled update of the guideline.

NICE has not yet been asked to produce national guidance on the long term conditions following a head injury or on hypopituitarism. If you think that this is a topic that we should look at, you can formally suggest it to us. Anyone can suggest a topic for the NICE work programme via the “get involved” section of the NICE website at www.nice.org.uk. Details about the criteria and selection process can also be found in this section.

We appreciate that you remain unhappy with our decision not to update the guideline but we feel we have now reached a point where it is not helpful to continue to debate this issue any further. We have addressed your FOI request and a number of further issues but we are unable to enter into further discussion with you about this guideline.

If you wish to formally complain about the way in we have handled your non-FOI enquiries, please write to the Institute, stating your concerns clearly, to:

Alana Christopher
Associate Director, Corporate Office
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London WC1V 6NA
Email: Alana.christopher@nice.org.uk

If you are unhappy with the initial response from the Associate Director- Corporate Office, you can ask for it to be reviewed by the Chief Executive, who may ask another director to undertake the review. If you remain dissatisfied, the complaint will be reviewed by a panel of two non-executive directors. If, following a non-executive director review, you are still unhappy with the decision of the Institute, you should be referred to the Parliamentary and Health Service Ombudsman.

A copy of this response is also being sent to you in the post.

Yours sincerely,


Teresa Birch
Communications Manager (Enquiry Handling)


DOCUMENT 22b (attached to Document 22a)


This consists of 14 pdf documents which are given in Appendices 4-17.



DOCUMENT 23
28 Southwood Avenue
Coulsdon
CR5 2DT

Ms Alana Christopher
Associate Director, Corporate Office
NICE
MidCity Place
71 High Holborn
London WC1V 6NA

10 September 2009


Dear Ms Christopher

I have been in correspondence with Ms Teresa Birch and Dr Fergus Macbeth since last November putting the case that NICE should do an exceptional update on their Head Injury guideline CG56, to include the high risk of pituitary dysfunction following moderate/severe traumatic brain injury, and to modify the sample discharge letter to warn that hypopituitarism may occur after a long interval, even after mild injury, but can be treated. On 17 August I heard their decision, that NICE will include the information in their next update in 2012, but not do an exceptional update.

I would like to lodge an appeal against this decision on the grounds that NICE:

 did not take into account the relevant research and were under a misapprehension about the number of people at risk
 misinterpreted the scope of CG56
 failed to demonstrate the truth of their statement that an exceptional update would not be targeting resources “in a way that gives the most benefit to the largest number of people” with a cost-benefit calculation

My brother-in-law Sir David Lane, FRS, FRSE, FRCPath, FRCS (Edin) F Acad Med Sci, FUCL, of whose discovery of the P53 gene Dr Macbeth is no doubt aware in his capacity as cancer specialist, has advised me that the first step in my appeal should be to ask you to examine the research on which I have based my estimate of how many people are affected. I quoted an annual incidence figure of 10,000-15,000 to Dr Macbeth. I have attached a document describing the research, and all I would ask from you at this stage is to decide whether you yourself agree with this figure, and if not, to provide your own estimate giving your reasons.

I will wait for your response.

Yours sincerely



Joanna Lane BA (Hons) Oxon

DOCUMENT 23 Attachment 1:

THE SCOPE OF CG56 AND THE NEED TO AMEND THE SAMPLE DISCHARGE LETTER

The scope of CG56 does include the diagnosis of complications which may lead to longterm disability
Dr Macbeth and his team claim that hypopituitarism falls outside the scope of CG56. However the original Scope document dated 2003 given in Appendix A of the full guideline says: “Most patients recover . . but in others, persistent disability or even death result from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment. Much of the controversy and uncertainty in the early care of head injured patients is focused upon how these patients are best managed.”

The scope document goes on to say that the guideline, while not addressing rehabilitation or long term care, ‘will provide criteria for the early identification of patients who would benefit from rehabilitation.’

This gives an unequivocal mandate for screening for a longterm complication such as neuroendocrine dysfunction.

Dr Macbeth’s team argue that this is the scope for the 2003 version, and that the 8 questions they were required to address for the 2007 update only related to getting head injured cases to expert care in a timely fashion, and that therefore they fulfilled their remit. However 1.17 of the full guideline published 2007 clearly states “Only 8 clinical questions . . are covered within this partial update; all other criteria set in the scope (Appendix A) were adhered to in this update.” The Scope in Appendix A is of course the 2003 Scope.

It is obvious that this must be so. Otherwise it would be illogical for a partial update to share the same status as a full update, as it does, and be valid for the same number of years. It would be like saying “We changed the windscreen wipers so we’re excused from doing an MOT.”

Dr Macbeth has therefore misunderstood the scope of CG56 and is incorrect in his objection that hypopituitarism falls outside it. In any case, by agreeing to include the information in the 2012 update he is tacitly admitting that it belongs there.

The discharge letter
The other very strong reason for amending the guideline is this. Bearing in mind that the onset of PTHP can come long after the injury [1, 2, 3] – even mild injury – it is essential to warn patients at the time of discharge. Otherwise who is going to check on them ten years later? How are they going to connect their misery and sexual failure with a head injury years ago, perhaps in childhood, and how will they know that they can be successfully treated?

Dr Macbeth’s team rests argues that the present sample discharge letter says ‘Most people recover quickly . . however some people only develop problems after a few weeks or months. If you start to feel that things are not quite right (for example, memory problems, not feeling yourself) then please contact your doctor as soon as possible . .’ However, I hardly need to point out that some vague words about ‘not feeling yourself’ in a few months’ time form no sort of adequate warning for a dreadful condition that may begin ten years into the future,.

References
[1] Hypopituitarism Secondary to Head Trauma, Benvenga S, Campenni A, Ruggeri R, Trimarchi F, J. Clin. Endocrin. & Metab. 2000.
http://jcem.endojournals.org/cgi/content/full/85/4/1353
A table of 15 survivors shows three males who had head injuries aged 11, 10 and 10 who were not diagnosed until ages 52, 45 and 40. Obviously these 3 boys must have grown normally during adolescence for their diagnosis to be so delayed.

[2] Brain Injury and Pituitary Dysfunction, Nachtigall L B, Massachusetts General Hospital Neuroendocrine Clinical Centre Bulletin, 2005.
http://www.massgeneral.org/endocrine/assets/pdfs/neuroendocrine/clinicalcenterbulletin/2005_v11_i2_brain_injur y_and_pituitary_dysfunction.pdf
“Longitudinal follow-up is necessary, as . . . some [patients] develop hypopituitarism as a late manifestation many years after the initial event.”

[3] Hypopituitarism after traumatic brain injury, Bondanelli et al, European Journal of Endocrinology, 2005
http://www.eje-online.org/cgi/content/abstract/152/5/679
“Diminished pituitary hormone secretion, caused by damage to the pituitary and/or hypothalamus, may occur at any time after traumatic brain injury.”


DOCUMENT 23 Attachment 2

POST-TRAUMATIC HYPOPITUITARISM – SYMPTOMS AND INCIDENCE

Symptoms
The pituitary gland controls the production of growth hormone, adrenocorticotrophic hormone which governs response to stress, and the glands that produce sex hormones. Damage to the pituitary can produce varying symptoms including loss of libido, erectile dysfunction in men, amenorrhea in women, infertility and depression.

The incidence of post-traumatic hypopituitarism after moderate to severe traumatic brain injury is well established at 25%
Since last August I have built up a collection of papers on PTHP which fills two lever-arch files. All these studies, starting with Daniel Kelly's 2000 paper and carrying through until now, and published by the Journal of Neurosurgery, Journal of Neurotrauma, Journal of Neurology, Neurosurgery and Psychiatry, JAMA, Pituitary etc, written by authors from many different countries, give incidences ranging from 20% to 50% for mod/severe injuries, but generally around the 25% mark. The only exception I can find is a paper by Karavitaki and Wass in 2006. I also have a letter from Professor Chris Thompson from Dublin, who has been responsible for much of the research himself, assuring me that the accepted figure of 20-30% after mod/severe injury still applies. I have his permission to quote him on this. Furthermore, Mr Antonio Belli at Southampton General has written to me that he is screening severe TBI patients and finding that one in four needs hormone replacement.

I believe the figure of 25% following moderate to severe TBI is as unassailable as 30 years of research and a series of large-scale studies and data reviews [1,2,3] culminating in a systematic review covering 19 studies including 1137 patients can make it. [4].

There are about 150,000 traumatic brain injuries a year in the UK [CG56 Appendix A]. Of these 15% are moderate to severe, i.e. around 22,500 [“Effects of Brain Injury” Headway leaflet]. A quarter of this comes to 5,600 cases. For the purposes of comparison, it may be helpful to observe that 7,237 patients were diagnosed with leukaemia and 7,600 with pancreatic cancer in the year 2006 [CRUK website].

The incidence of PTHP after all traumatic brain injury including mild is less well established
In the case of the 137,500 mild TBI cases the picture is less clear. PTHP is well documented to occur after mild injury, sometimes so mild that the patient does not remember it himself and has to be prompted by family members. [5, 6]. However the incidence after all head injury including mild is much less consistently recorded, and here I believe the figure ranges from 50% [7] from a study using 71 consecutive patients, to 16% [8] (a study involving 104 patients) and to 7-10% (I quote from an email from Dr Tara Kearney to Mr Stephen Greep at Hull Royal Infirmary which she copied me in on, basing her figure on unnamed research). To be conservative I took Dr Kearney’s incidence, which gives 10,000-15,000, and this was the figure I gave to NICE. In other words, even the most conservative current research suggests there as many people with PTHP as there are people diagnosed with pancreatic cancer and leukaemia put together.


References
[1] Anterior pituitary dysfunction in survivors of traumatic brain injury Agha A, Rogers B, Sherlock M et al, J Clin Endocrinol Metab 2004
http://www.ncbi.nlm.nih.gov/pubmed/15472187?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum&log$=freejr
Tested 102 consecutive mod/severe TBI survivors, found hypopituitarism in 28.4%

[2] Anterior Pituitary Hormone Abnormalities following Traumatic Brain Injury, Schneider M, Schneider HJ, Stall GK, J. Neurotrauma 2005 http://www.ncbi.nlm.nih.gov/pubmed/16156709
Reviews 5 studies including 364 patients, ‘partial anterior hypopituitarism after TBI is a common finding with a prevalence of at least 30%.’

[3] Neuroendocrine disorders after traumatic brain injury, Behan LA, Phillips J, Thompson CJ, Agha A, J Neurol Neurosurg Psychiatry 2008
http://jnnp.bmj.com/cgi/content/full/79/7/753
Summarizes data from 12 studies covering 961 TBI patients giving prevalence of anterior hypopituitarism as approximately 25%.

[4] Hypothalamopituitary Dysfunction Following Traumatic Brain Injury and Aneurysmal Subarachnoid Hemorrhage: A Systematic Review, Schneider HJ, Kreitshmann-Andermahr I, Ghigo E et al, JAMA 2007
http://jama.ama-assn.org/cgi/content/full/298/12/1429
Reviews 19 studies including 1137 patients. Pooled prevalences of hypopituitarism in chronic phase after TBI and SAH were 27.5% and 47% respectively.

[5] Hypopituitarism Secondary to Head Trauma, Benvenga S, Campenni A, Ruggeri R, Trimarchi F, J. Clin. Endocrin. & Metab. 2000.
http://jcem.endojournals.org/cgi/content/full/85/4/1353
“We learned that head trauma can be minor and had occurred several years earlier, so that the patient may lose recollection of it” Re late onset, a table of 15 survivors shows three males who had head injuries aged 11, 10 and 10 who were not diagnosed until ages 52, 45 and 40. Obviously these 3 boys must have grown normally during adolescence for their diagnosis to be so delayed.

[6] Should every patient with traumatic brain injury be referred to an endocrinologist? Aimaretti G, Ghigo E, Nature Clinical Practice Endocrinology & Metabolism, 2007
http://www.nature.com/nrendo/journal/v3/n4/full/ncpendmet0460.html
“It has been reported the severe hypopituitarism could occur in patients who have suffered mild head trauma(GCS 13-15), which suggests the need for endocrine evaluation in this patient group. Unfortunately, however, this type of trauma is often so minor that patients have no recollection of its occurrence, even after direct questioning, and only family members are able to remember the event.”

[7] A prospective longitudinal study of anterior pituitary dysfunction following traumatic brain injury, Kleindienst A et al, Endocrine Abstracts 2007.
http://www.endocrine-abstracts.org/ea/0013/ea0013p231.htm
71 consecutive survivors of mild, moderate and severe TBI prospectively studied at acute stage and after 2-3 years. 50% showed hypopituitarism at 2-3 years.

[8] Prevalence of predictive factors of post-traumatic hypopituitarism, Klose M et al, Clin Endocrinol (Oxf) 2008
http://www.ncbi.nlm.nih.gov/pubmed/17524035
A study of 104 survivors of mild, moderate and severe traumatic brain injury. 16% had pituitary dysfunction.


DOCUMENT 24

From: “Alana Christopher” Alana.Christopher@nice.org.uk
To: “Joanna Lane” joannalane@blueyonder.co.uk
Sent: 09 October 2009 19:42
Subject: RE: updating CG56

Dear Ms Lane,

I am writing further to your email of 11th September 2009, regarding your request for an exceptional update of Head Injury guideline (CG56). I have now reviewed the matters you raised in accordance with the Institute’s complaints procedure.
I am sorry that you were not satisfied with the response to your Freedom of Information request.
You have appealed against this decision on the grounds that NICE:

 did not take into account the relevant research and were under a misapprehension about the number of people at risk
 misinterpreted the scope of CG56
 failed to demonstrate the truth of their statement that an exceptional update would not be targeting resources “in a way that gives the most benefit to the largest number of people” with a cost-benefit calculation

In preparing my response, I have taken advice from those at NICE who have knowledge of the guideline.

The key issue is whether or not the topic of hypopituitarism following head injury was or was not within the scope of the original and updated guideline. Although you quite correctly quote the scope document as saying that ‘Most patients recover ... but in others, persistent disability or even death result from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment’ this comes from the introductory background section entitled ‘Clinical need and practice’. The scope itself is defined in the following three sections (Population, Healthcare setting and Interventions and treatment). In these it is clear that the clinical guideline was only to cover the early management of patients with head injury. The scope was consulted on and agreed at that time. In our view it does not include the identification and management of the late complications of head injury such as pituitary failure.

We therefore do not believe that the scope was misinterpreted when being considered for update and the question of whether or not the relevant evidence on the incidence of pituitary failure was taken into account is not relevant. If the guideline had included follow up and long term management of complications had been within the scope the situation would of course be very different.

In your email, you stated that NICE has not demonstrated the cost benefit analysis on which NICE decided not to update the clinical guideline on head injury. The decision whether or not to update a clinical guideline is not informed by a health economic analysis and there is no methodology for doing that. That decision is made only on the extent to which the evidence base has changed and any decision to update the guidance is then prioritised on the basis of our available capacity.

Your email also stated that the sample discharge letter should warn that hypopituitarism may occur after a long interval. As you know the guideline did include a recommendation which said: ‘All patients and their carers should be made aware of the possibility of long-term symptoms and disabilities following head injury and should be made aware of the existence of services that they could contact should they experience long-term problems. Details of support services should be included on patient discharge advice cards. This did not prescribe what should exactly be included in that information and could not do, because long term consequences had not been formally reviewed for the guideline.

As an acknowledgment of the possible importance of this topic, we think it may be helpful to propose the development of a clinical guideline on the identification of pituitary failure following head injury. We will need to discuss the proposal with the Department of Health, which commissions NICE to prepare guidance for the NHS. Given that there are already a number of clinical guideline topics waiting to be considered for development, I am not able to guarantee that we will be able to take this one forward.
.
Neither I nor Dr Macbeth can comment on the accuracy of your estimate of the incidence of the condition but this will be carefully considered when a proposal for a clinical guideline on the topic is prepared. In addition to the evidence which you have helpfully cited, we are also aware of the very recently published paper from Germany (Exp Clin Endocrinol Diabetes 2009 Aug 18) reporting that 20% of 246 patients had biochemically identifiable pituitary dysfunction following traumatic brain injury.
I hope this information is helpful. If, however, you are unhappy with this decision you can request a review by the Chief Executive of NICE in accordance with the Institute’s complaints procedure that you have been sent.

Yours sincerely


Alana Christopher
Associate Director - Corporate Office


DOCUMENT 25

From: Joanna Lane
To: Alana Christopher
Sent: Friday, October 23, 2009 8:27 AM
Subject: I wish to appeal against your decision on CG56

Dear Ms Christopher

Thank you for your response to my appeal, and for going through my points so carefully. Thank you also for the suggestion that you might develop a clinical guideline on the identification of pituitary failure following head injury. This is a good suggestion and I agree, though it will take a few years and not solve the immediate crisis.

As you say, much hinges on the scope, and also I think on the number of people who will be affected. The discharge letter also merits discussion. I will take these points in turn.

The scope
I believe any impartial reader of the "Background and Scope" section (pp 30-40 of the full guideline) would summarise it as follows. "The guideline is intended to guide professionals in managing the acute stage of head injury in such a way as to minimize later complications." To claim that the guideline covers "early management", full stop, is seriously to truncate and misrepresent the scope.
I conclude this not only because of the comments I referred to before, in Appendix A, 3.5, about complications causing 'persistent disability or even death' which can be 'minimised with early detection and treatment', but also because of the following specific and unambiguous sentences in 4.11 and 6.18.3.
 The guideline will provide criteria for the early identification of patients who would benefit from rehabilitation
 The guideline will include . . secondary care with the aim of early detection of intracranial complications . . the aim is . . to arrange for appropriate diagnostic procedures and treatment.
I am puzzled by your silence about these parts of the scope. I cannot think you wish to imply that the pituitary is not situated in the cranium and that damage to it is not a 'complication', or that hormone replacement does not form a part of the patient's rehabilitation, the process whereby he/she is helped to live a normal life again.

I will cite here also the statement from 6.18.3, that the guideline will advise of tne appropriate use of imaging procedures such as CT scans. Pituitary damage can potentially (though not invariably) be picked up by scans. It would seem an obvious step to examine the pituitary in the acute stage at the same time as checking for intracranial haemorrhage etc, on the grounds that:
 ACTH deficiency is life-threatening in the acute stage
 the probability of the fragile pituitary being damaged is so high (20-30%) in injuries below 13 on the Glasgow Coma Scale
 doing a separate scan later for pituitary damage would double the expense
For your interest I attach an article with an image of a damaged pituitary gland (Fig 3). The patient, with whom I have corresponded, had a serious head injury aged 20. She was not diagnosed with pituitary trouble for 10 years, during which time she had five miscarriages and a still-birth. A scan of her pituitary at the time of her accident might have saved her much heartache.

The number of people affected
I was interested in the new research you mentioned where 20% of the 246 mod/severe patients had pituitary damage. This fits with Professor Chris Thompson's letter to me putting the incidence at 20-30%. When this research is 'put into the pot' with Schneider's systematic review covering 1137 patients and giving 27.5% incidence, it brings the incidence down to about 26%.
I was disappointed that you and Dr Macbeth did not share with me the conclusions you must have come to between yourselves about how many people are affected each year. I am inclined to infer from this that you do not seriously challenge my figure of between 10,000 and 15,000 people annually - an estimate which was very conservatively arrived at.
Although you say that cost is not a factor in deciding whether to do an exceptional update, I think it does have some influence. Dr Macbeth not only mentioned it to me ("it's important for us to target our resources in a way that gives most benefit to the largest number of people") but also in his email of 5 June to an unnamed endocrinologist "Her view is that this is a 'serious error' that would justify .. further guidance being issued. This would of course entail considerable resource to do, and we could not do it unless there was sufficient justification.") To me, the risk of 30,000 to 45,000 pituitary patients remaining undiagnosed over the next 3 years is sufficient justification, and I feel that now you have examined the research in more detail you must agree with me.

Discharge letter
I agree that NICE does not dictate to hospitals what the discharge letter should say.
However the reality is that hospitals copy the NICE sample discharge letter verbatim. If the discharge letter isn't reliable or complete there should be a disclaimer, to protect the hospital (and indeed NICE) from legal action later. But how much better than a disclaimer would be a few words inserted now, at very little cost, which would keep the patient safe!

In summary then, I wish to appeal against your decision for three reasons:

 You have misunderstood the scope of CG56
 Too many patients will suffer harm over the next 3 years to leave the guideline unchanged
 The sample discharge letter is unreliable and incomplete

Yours sincerely

Joanna Lane BA (Hons) Oxon


DOCUMENT 26

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 30 October 2009 21:58
To: Andrew Dillon
Subject: Fw: I wish to appeal against your decision on CG56

Dear Mr Dillon

I believe I should have sent this to you rather than Ms Christopher.

Yours sincerely

Joanna Lane

----- Original Message -----
From: Joanna Lane
To: Alana Christopher
Sent: Friday, October 23, 2009 8:27 AM
Subject: I wish to appeal against your decision on CG56

Dear Ms Christopher

Thank you for your response to my appeal, and for going through my points so carefully. Thank you also for the suggestion that you might develop a clinical guideline on the identification of pituitary failure following head injury. This is a good suggestion and I agree, though it will take a few years and not solve the immediate crisis.

As you say, much hinges on the scope, and also I think on the number of people who will be affected. The discharge letter also merits discussion. I will take these points in turn.

The scope
I believe any impartial reader of the "Background and Scope" section (pp 30-40 of the full guideline) would summarise it as follows. "The guideline is intended to guide professionals in managing the acute stage of head injury in such a way as to minimize later complications." To claim that the guideline covers "early management", full stop, is seriously to truncate and misrepresent the scope.
I conclude this not only because of the comments I referred to before, in Appendix A, 3.5, about complications causing 'persistent disability or even death' which can be 'minimised with early detection and treatment', but also because of the following specific and unambiguous sentences in 4.11 and 6.18.3.
 The guideline will provide criteria for the early identification of patients who would benefit from rehabilitation
 The guideline will include . . secondary care with the aim of early detection of intracranial complications . . the aim is . . to arrange for appropriate diagnostic procedures and treatment.
I am puzzled by your silence about these parts of the scope. I cannot think you wish to imply that the pituitary is not situated in the cranium and that damage to it is not a 'complication', or that hormone replacement does not form a part of the patient's rehabilitation, the process whereby he/she is helped to live a normal life again.

I will cite here also the statement from 6.18.3, that the guideline will advise of tne appropriate use of imaging procedures such as CT scans. Pituitary damage can potentially (though not invariably) be picked up by scans. It would seem an obvious step to examine the pituitary in the acute stage at the same time as checking for intracranial haemorrhage etc, on the grounds that:
 ACTH deficiency is life-threatening in the acute stage
 the probability of the fragile pituitary being damaged is so high (20-30%) in injuries below 13 on the Glasgow Coma Scale
 doing a separate scan later for pituitary damage would double the expense
For your interest I attach an article with an image of a damaged pituitary gland (Fig 3). The patient, with whom I have corresponded, had a serious head injury aged 20. She was not diagnosed with pituitary trouble for 10 years, during which time she had five miscarriages and a still-birth. A scan of her pituitary at the time of her accident might have saved her much heartache.

The number of people affected
I was interested in the new research you mentioned where 20% of the 246 mod/severe patients had pituitary damage. This fits with Professor Chris Thompson's letter to me putting the incidence at 20-30%. When this research is 'put into the pot' with Schneider's systematic review covering 1137 patients and giving 27.5% incidence, it brings the incidence down to about 26%.
I was disappointed that you and Dr Macbeth did not share with me the conclusions you must have come to between yourselves about how many people are affected each year. I am inclined to infer from this that you do not seriously challenge my figure of between 10,000 and 15,000 people annually - an estimate which was very conservatively arrived at.
Although you say that cost is not a factor in deciding whether to do an exceptional update, I think it does have some influence. Dr Macbeth not only mentioned it to me ("it's important for us to target our resources in a way that gives most benefit to the largest number of people") but also in his email of 5 June to an unnamed endocrinologist "Her view is that this is a 'serious error' that would justify .. further guidance being issued. This would of course entail considerable resource to do, and we could not do it unless there was sufficient justification.") To me, the risk of 30,000 to 45,000 pituitary patients remaining undiagnosed over the next 3 years is sufficient justification, and I feel that now you have examined the research in more detail you must agree with me.

Discharge letter
I agree that NICE does not dictate to hospitals what the discharge letter should say.
However the reality is that hospitals copy the NICE sample discharge letter verbatim. If the discharge letter isn't reliable or complete there should be a disclaimer, to protect the hospital (and indeed NICE) from legal action later. But how much better than a disclaimer would be a few words inserted now, at very little cost, which would keep the patient safe!

In summary then, I wish to appeal against your decision for three reasons:

 You have misunderstood the scope of CG56
 Too many patients will suffer harm over the next 3 years to leave the guideline unchanged
 The sample discharge letter is unreliable and incomplete

Yours sincerely

Joanna Lane BA (Hons) Oxon



DOCUMENT 27

----- Original Message -----
From: Andrew Dillon
To: 'Joanna Lane'
Cc: Alana Christopher ; Fergus Macbeth
Sent: Monday, November 30, 2009 11:42 AM
Subject: RE: I wish to appeal against your decision on CG56

Dear Ms Lane,

Thanks you for your email. I am sorry for the delay in responding to it. I have spoken to both Alana Christopher and Dr Fergus Macbeth about the responses they have sent to your earlier correspondence.

Although it has no effect on my response to your most recent email, I just wanted to let you know how we have been dealing with your enquiries.

You originally approached us using the Freedom of Information Act and we responded accordingly. All the information we hold, which we are able to give you and which relates to your enquiries, has been released. Although we were happy to respond under our Freedom of Information Act procedure, it was quickly obvious that your real aim has been to persuade us to review our clinical guideline on the triage, assessment, investigation and early management of head injury in infants, children and adults. Our recent correspondence has therefore been outside of the Freedom of Information Act and we have continued it because we understand the matter is important to you and because we do our best to engage with members of the public when they approach us with concerns about our work. I mention all this partly because I want you know that we have taken your enquiries seriously and because, although you refer to your recent email as an ‘appeal’ we are not treating it as such, since we are not engaged in a process which has an appeal stage to it.

In reviewing our earlier correspondence, my concern has been to make sure that we have balanced your arguments for a different interpretation of the scope. However broadly the scope, as set out in the full guideline, could be interpreted, it was not intended to identify and cover all the potential complications of head injury. It was reasonable for the Institute and the guideline developers to identify the limits of what they considered to be ‘early management’. This leads me to take the view that the interpretation of the scope was a reasonable one and that to exclude the identification and management of late complications was consistent with the Department of Health’s intention in commissioning the guideline from us.

In saying this. I do understand that a proportion of patients with a head injury will develop biochemically identifiable pituitary abnormalities. However, I do not consider that this constitutes a sufficient risk of serious harm to justify incorporation into this guideline as an immediate update. Nor have we been made aware from independent sources, in the NHS, that there is a 'crisis' with this condition that needs immediate remedy. The decision to refer the topic into the selection process for clinical guidelines is both appropriate and proportionate, given the importance of the issue and the need for us to balance our guideline development capacity across all the demands made on clinical services provided by the NHS.

I am not really able to add to the points that have already been made in our earlier corresoondence about the discharge letter. I understand that you feel that it is unsatisfactory and unsafe because it does not make specific reference to the possibility of pituitary problems. However, it does draw attention to the risk of long term problems, (of which, of course, pituitary failure is just one) and advises that some people only develop problems after a few weeks or months. It also recommends that patients should contact their doctor as soon as possible if they feel that things are not quite right, for example, if they are experiencing memory problems, or otherwise not feeling well. This approach seems balanced and proportionate to the likelihood of complications. It could be argued that it would be inappropriate and potentially alarming to enumerate all the possible late effects and their clinical symptoms in a document which is intended to help make patients aware of the possibility of complications and the need to seek advice when that might be the case. .

I appreciate that this is not the response you will have been hoping for, nor, I suspect, will you agree with it. However, we have to make judgements about how best to apply our resources and I believe that the position we have taken is reasonable in the circumstances, even though I accept that an alternative view can be argued.

We will be happy to keep you up to date with progress in considering the matter as a separate clinical guideline, if you wish.

Yours sincerely,

Andrew Dillon
Chief Executive
National Institute for Health and Clinical Excellence


DOCUMENT 28

From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 07 January 2010 16:50
To: Andrew Dillon
Cc: Alana Christopher; Fergus Macbeth
Subject: Re: I wish to appeal against your decision on CG56

Dear Mr Dillon

I hope you had a good Christmas.

Thank you for explaining your reasons for not doing an exceptional update on CG56.

However, your refusal is predicated on the assumption that post-traumatic hypopituitarism is a 'late complication.'

It is not a late complication. It is an early one. If you refer to Schneider's systematic review (link sent to NICE on 11/9/09 http://jama.ama-assn.org/cgi/content/full/298/12/1429 ) you will see that the highest incidence comes at the acute stage, where percentages of up to 80% have been recorded. At this stage deficiency of thyroid-stimulating hormone, adrenocorticotrophic hormone and anti-diuretic hormone have all been associated with high mortality.

To sum up then: both your 2003 and 2007 guidelines omitted to mention a common, life-threatening complication included in the narrowest definition of the scope. This is an error which puts patients at risk and by your own rules you are obliged to correct it immediately. You do not have the latitude to 'balance your guideline development capacity' across the demands. It is like a parking fine. However inconvenient, you have to grit your teeth and pay.

With best regards

Joanna Lane



DOCUMENT 29

Sent by Mr Andrew Dillon to Joanna Lane on 11 January 2010 12:03


Dear Ms lane,

Thank you for your email.

I agree that the systematic review which you cite refers to evidence that the incidence of biochemically identified hypopituitarism is higher in the acute phase. The figure of 80%, which you refer to, is for LH/FSH (gonadotrophins) only, and only in one of the two studies. The rate of ACTH deficiency, which if severe would be the only life threatening complication, is cited as 12%. The clinical significance of these biochemical findings is not clear. The review itself states that: ‘Early posttraumatic pituitary dysfunction can be transient in many cases and conversely, hypopituitarism can evolve over several weeks or months after injury.’

In addition, the abstracts of two papers listed at the end as citing this paper include the following two statements:

‘By applying strict diagnostic criteria to an emergency-department-based cohort of TBI patients, it was shown that anterior pituitary dysfunction is rare (<1%). Routine pituitary screening in unselected patients after TBI is unlikely to be cost-effective.’ van der Eerden et al (2010)

‘The reported variations in the prevalence rates of hypopituitarism after TBI are in part caused by differences in definitions, endocrine assessments of hypopituitarism, and confounding factors. These methodological issues prohibit simple generalizations of results of original studies on TBI-associated hypopituitarism in the perspective of meta-analyses or reviews.’ Kokshoorn et al (2010).

We do have to take informed decisions the best way to allocate our limited resources and I remain of the view that the best approach to this topic is a clinical guideline which addresses the question as to whether routine screening of patients following traumatic brain injury for pituitary dysfunction is clinically and cost effective.

Yours sincerely,

Andrew Dillon
Chief Executive


DOCUMENT 30
From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 23 June 2010 17:49
To: Fergus Macbeth
Cc: Alana Christopher; ottawayr@parliament.uk
Subject: CG56 update
Dear Dr Macbeth
When I enquired recently about the proposed new guideline about post-traumatic hypopituitarism, my attention was drawn to the minutes of the 15 March meeting of the Topic Selection Consideration Panel, Acute and Chronic Conditions.
The relevant passage reads:

6.8 Identification of late pituitary failure following head injury (3392)
This topic was introduced by Dr Colm Leonard. A significant percentage of patients develop pituitary abnormalities following traumatic brain injury. Pituitary abnormalities may arise quite some time after the injury. Specific endocrine testing is necessary to diagnose the problem. There is no known statistical racial predisposition in relation to traumatic brain injury (TBI). Children are particularly at risk due to growth hormone deficiency. This problem is under recognised and under diagnosed.
The Panel queried why this is not covered in Head injury (CG56). It was noted that the scope of the head injury guideline focuses on early management so this topic would not be included in any future update.
I was surprised to read this as you assured me in your letter of 11 June last year that "when the guideline is updated we will ensure that this issue is addressed". Ms Teresa Birch repeated this promise in her letter of 29 June with the words "As we've already stated, when the guideline is updated we will ensure that this issue is addressed." The scope of guideline CG56, which of course was defined many years ago, has in no way altered since this promise was made.
I would welcome your assurance that NICE is going to honour its promise to me. I have copied in Mr Richard Ottaway my MP into this correspondence as he is kindly taking an interest in this important health problem.
With kind regards
Joanna Lane
__________________________

DOCUMENT 31
From: Joanna Lane [mailto:joannalane@blueyonder.co.uk]
Sent: 01 July 2010 20:27
To: Jane Cowl
Subject: updating of CG56 head injury

Dear Jane Cowl

I am writing to you in the hope that you canadvise me on what steps I can take to ensure that important and potentially life-saving information is included in the forthcoming update of the head injury guideline CG56. I understand an update is scheduled for this September.

I have been in correspondence with NICE for more than a year, since our son's suicide, urging that an exceptional update should be done, to include information on the high risk of hypopituitarism after traumatic brain injury. This information was omitted in both the 2003 and 2007 versions, even though research on this topic has been coming out since the 1980s and has increased dramatically since 2000.

Dr Macbeth refused to do an exceptional update but promised me that the matter would be addressed in the scheduled update, i.e. in September 2010. However I am now surprised and concerned to hear that the information will not be included even now. NICE is going through consultation on producing a separate guideline on the identification of hypopituitarism and claims that a separate guideline would make it unnecessary to include the information in the main guideline. They say that the scope of the main guideline covers only the acute stage.

I am very unhappy about this decision for the following reasons:
 pituitary dysfunction is important to recognize even in the acute stage. A deficiency of the hormone ACTH can be life-threatening in the acute stage and occurs in 12% of cases (Mr Dillon himself conceded this in an email to me)
 the scope of CG56 specifically states that "the guideline will provide criteria for the early identification of patients who would benefit from rehabilitation" (4.11 full guideline) and "the guideline will include ... secondary care with the aim of early detection of intracranial complications . . the aim is . . to arrange for appropriate diagnostic procedures and treatment." (6.18.3). Pituitary failure is an intracranial complication which requires diagnosis and treatment.
 The sample letter of discharge included in the guideline gives no warning, and is used verbatim by most hospitals. It is the patient's right to receive full information about the risks of his condition.
We are talking about a condition that can destroy a person's sexuality and fertility, causing impotence in men, loss of periods in women, depression, uncontrollable weight gain, failure to grow in children - and it is treatable.

An article last August highlighted the large numbers involved:
Given the large number of individuals who fall victim to TBI and SAH each year, post-traumatic hypopituitarism becomes an entity of major public health significance. Based on the incidence of patients hospitalized for TBI and SAH reported in the literature and the frequencies of hypopituitarism in these patients, the incidence of hypopituitarism caused by these disorders is estimated to be more than 30 per 100,000 per year. [1]
It is possibly the very size of the problem which is causing NICE's reluctance to open it up, given the current economic climate. But it is unethical to attempt to ease the NHS's financial problems by leaving a huge tranche of patients in the dark about their condition - which is what will happen if the discharge advice is left in its current state - and with no chance of fighting for their share of the available resources. And as I said before, it is a human right to be informed about one's condition, its risks and the treatment available.

Here is a link to a 2007 systematic review which covers more than 1000 patients and finds an incidence of 27.5% after traumatic brain injury and 47% after subarachnoid haemorrhage. www.ncbi.nlm.nih.gov/pubmed/17895459

I do hope you can help me in this very important matter.

With best wishes

Joanna Lane BA (Hons) Oxon



[1] Hypopituitarism and brain injury: recent advances in screening and management, Pickel J et al, F1000 Medicine Reports 2009, http://webcache.googleusercontent.com/search?q=cache:1LOB5-_Ni-0J:f1000medicine.com/reports/10.34





DOCUMENT 32

----- Original Message -----
From: NICE Mail
To: Joanna Lane
Sent: Wednesday, July 07, 2010 5:16 PM
Subject: RE: FW: CG56 update

Dear Ms Lane

Thank you for your email sent to Dr Macbeth on 23 June 2010 and your email sent to Jane Cowl on 1 July 2010.

Dr Macbeth has considered these emails and asked me to respond on behalf of NICE.

In your email to Dr Macbeth you refer to statements made in our letters to you dated 11 June and 29 June 2009. At the time of writing, we believed that the issues you raised would be covered when the head injury guideline (CG56) was considered for possible update. However, on further investigation, and as explained in our subsequent letters to you of 17 August, 9 October and 30 November 2009, we realised that the broader issue of post head injury hypopituitarism may not in fact be covered in a possible future update of the guideline because the existing scope of the head injury guideline (CG56) was to provide recommendations on the early management of head injury.

In acknowledgement of the fact that identification and management of pituitary failure following head injury may not fit within the scope of CG56 when we consider a review of the guideline and, in recognition of the possible importance of developing stand alone guidance on this topic, a suggestion to propose a new clinical guideline topic was made.

As you are aware from the topic selection minutes of 15 March 2010, the Acute and Chronic Conditions Consideration Panel suggested that a short clinical guideline on the identification of late pituitary failure following head injury, for both adults and children, providing advice on when to refer, what tests should be used and how often the tests should be performed, would be useful. Our Programme Manager for Topic Selection has explained the next step in the topic selection process and made you aware that there is no capacity within the short clinical guideline work programme to begin work on new topics at this present time. This does not mean that NICE will not produce guidance on this issue in the future. There is a possibility that the topic will be considered by the Referral Oversight Group (ROG) in September when capacity becomes available within the short clinical guideline programme.

As Andrew Dillon replied in his email to you in November, we are happy to keep you up to date with the progress of the proposed topic suggestion and I would ask you to contact me directly in respect of this.

In response to the additional points you raise in your email to Jane Cowl, as we have already explained previously, we are unable to continue to debate issues around updating the existing guideline or the intended scope.

Regards

Teresa

Teresa Birch
Communications Manager (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3134 | Fax: 44 (0)845 003 7785
Web: http://nice.org.uk

DOCUMENT 33

From: Joanna Lane
Received: 7/22/2010 10:29 AM
To: NICE Mail
Subject: Re: FW: CG56 update
Dear Teresa

Thank you for this response.

I now see that I did not read your letters last autumn carefully enough and I apologise. I thought that NICE's arguments about the scope were aimed at denying there was an error in CG56, and that the separate guideline was a substitute for the exception update I was asking for. I did not realise that the routine update would be completely silent about hypopituitarism.

Now that you have explained, however, I strongly feel that I cannot leave the matter as it is, for reasons that I explained in my email to Jane Cowl.

I know that NICE feels it has reached the point where it believes further communication on this topic is not fruitful. I too feel this and would now like to appeal directly to the Health Service Ombudsman.

However in his final reply to me, Mr Andrew Dillon made a point of saying that he was not treating my correspondence as a complaint, and this makes me wonder whether I should go through the motions of putting in a formal complaint and whether you should similarly go through the motions of turning it down before I approach the ombudsman, as I see that this is a requirement.

I would be grateful if you would clarify this for me.

With best wishes

Joanna


DOCUMENT 34
----- Original Message -----
From: Moya Alcock
To: 'Joannalane@blueyonder.co.uk'
Cc: NICE Mail
Sent: Thursday, August 19, 2010 3:16 PM
Subject: Re: FW: CG56 update

Dear Joanna,

Thank you for your email dated 22/7/10 sent to Teresa Birch in my team. Teresa is out of the office this week so I am responding on her behalf.

I appreciate that you remain unhappy and would like to take the issue further. With regards to your question about whether you need to submit a ‘formal’ complaint before taking your concerns to the Parliamentary and Health Services Ombudsman, I have discussed this with our Corporate Office who oversee our complaints process and we think that if you wish to take this further it would be appropriate for you now to go directly to the Parliamentary and Health Services Ombudsman as our complaints procedure does not cover complaints against our guidance.

My understanding is that the basis for your complaint is your unhappiness with our decision not to update CG56 in order to include guidance relating to the risk of hypopituitarism following brain injury. We have investigated and responded fully to your request and the concerns and questions you have raised with us about CG56 (responses sent to you on 28/11/08, 29/12/08, 27/02/09, 24/03/09, 15/04/09, 11/06/09, 29/06/09, 17/08/09). In addition, in response to the complaint you made on 11/09/09, our correspondence with you was reviewed by Alana Christopher, Associate Director - Corporate Office, (response sent to you on 9/10/09) and subsequently by Andrew Dillon, Chief Executive, (response sent to you on 30/11/09).

As you have already received a final response from us, and you still remain unhappy, it is appropriate to now take your concerns to the Parliamentary and Health Services Ombudsman at the address below.
The Parliamentary and Health Service Ombudsman
Millbank Tower
Millbank
London
SW1P 4QP
Tel: 0345 015 4033
Email: phso.enquiries@ombudsman.org.uk

Kind regards,

Moya Alcock
Associate Director (Enquiry Handling and Internal Communications)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 44 (0)161 870 3131 Fax: 44 (0)845 003 7785
Web: http://nice.org.uk
 

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