The Draft NICE Guidance is available for Feedback - Thyroid UK

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The Draft NICE Guidance is available for Feedback

NICE (National Institute for Health and Care Excellence) have now published their draft guidance on Thyroid disease: assessment and management.

The guidance includes supporting evidence although in many areas there was not enough evidence to come to a decision other than the experience of the committee.

Thyroid UK has long thought that there wasn’t enough evidence for NICE to create guidance and has said continuously that more research needs to be done to enable patients to access the medical care they need including a choice of medications.

Thyroid UK is a registered stakeholder and will be submitting a response before the consultation for feedback ends on 17th July.

We are very keen for thyroid patients to give feedback to this guidance, even though there is a lot of reading to do to understand the reasons given for the recommendations by the thyroid guidance committee.

To view the draft guideline (recommendations only) go to: nice.org.uk/guidance/GID-NG...

To see all of the evidence reviews for all of the areas within the guidance including supporting documentation go here:

nice.org.uk/guidance/indeve...

You can give feedback in two ways:

•Via the NICE guidance website -

NICE state that, "We can accept comments from individuals. These will be considered, but you won’t get a formal response and they won’t be posted on the NICE website. Wherever possible we encourage you to submit your comments through a registered stakeholder organisation.”

If you want to comment directly to NICE, you must use their comments form:

nice.org.uk/guidance/GID-NG...

•Via Thyroid UK -

You can send your comments to us at enquiries@thyroiduk.org and we will try to include them in our feedback. Please put "NICE feedback" into the subject line of the email.

Comments will need to be sent to us by 10th July.

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I've had a look at the guidance and it is very worrying. It seems to consolidate all that has been bad over the last 20 years or so. Up until now doctors like Dr Skinner were able to defend themselves by stating there were no guidelines. In future this defence will not be available and I fear doctors will be even more afraid of looking after their patients. I will send a response to NICE and send you a copy of my comments to the BTF. It's frustrating that NICE only allow a decent degree of patient involvement after they have written the guidance.

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A rehash of the current status quo. Blaming lack of evidence of benefit on the medication, not on lack of interest in research or trials and recording. Not to mention the systematic withdrawal of the medications over the last 4 years! Decision making on poor or no evidence, and limited committee experience as Lyn has mentioned. Poor rationale. Seemingly ignoring all patient experience supplied and, then saying based on current practice. Even though current practice does include some T3 and NDT issue. Then the contradictions throughout the SCH section.

Yep jimh111 very worrying indeed and if they get to implement this guidance just how long will be have to live and die by it? They are not going to rush to amend and update in the current £ climate? The word 'stitched' comes to mind. Back in Sept/Oct 2017, at the public NICE meeting Sir Andrew Dillon and Sir David Haslam assured us that patient voice was important and would be heard. I see nothing in this document to back that up or instil confidence. Lip service. I fear being asked to be stakeholders was a tick box exercise to fill their 'patient involvement' quota! Scary.

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It would be very interesting to see your comments. Any chance that you can post them on this site?

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Here it is. (Please note my comments on RAI and brain cells is pure speculation, a possible explanation of why a few people do so terribly after RAI. This should not be taken as fact, rather a potential explanation and a reason why RAI should be used cautiously with doses kept to a minimum. It it were me I would prefer surgery (if I am fit enough) and if I had thyroid cancer would prefer RAI after surgery. We have to balance real and potential risks, just like other fields of medicine.)

Comments on NICE Guideline

Thank-you for the opportunity to comment on this guideline.

Guidelines can unintentionally restrict diagnostic and therapeutic options. Whilst this is appropriate for some conditions, for example cancer treatment or surgical techniques, it is inappropriate for thyroid disease which has many aetiologies and presentations. This guideline should emphasise the need for a choice of treatment options that best suit individual patients.

We should take the opportunity to correct two cases of incorrect terminology: -

The term ‘reference range’ is misleading. Doctors wrongly interpret it as a diagnostic or therapeutic range. The correct term ‘reference interval’ should be used, this will assist doctors and patients in understanding blood test results.

The term ‘subclinical hypothyroidism’ is misleading and confusing. Some patients have severe signs and symptoms with a mildly elevated TSH whilst others are asymptomatic with a TSH > 10.0 mU/L. The absurdity of this term is demonstrated in the guideline’s ‘recommendation for research’ number 7 which refers to ‘symptomatic subclinical hypothyroidism’. My all-time favourite is this study: Mallipedhi, A., Vali, H., & Okosieme, O. (2011). Myxedema coma in a patient with subclinical hypothyroidism. Thyroid: Official Journal of the American Thyroid Association, 21(1), 87–89. LINK: ncbi.nlm.nih.gov/pubmed/210... . It has been proposed ‘subclinical hypothyroidism’ be replaced with ‘mild thyroid failure’. This is presumptuous, TSH can vary according to age and genetics. A better term is ‘elevated TSH’, easy to understand and makes no assumptions.

The guideline only considers primary hypothyroidism. This should be made clear, pointing out there are multiple causes of hypothyroidism e.g. primary, central, resistance to thyroid hormone, endocrine disruption, subnormal TSH secretion (down-regulated axis) etc. It should be stated the guidelines do not apply to any condition other than uncomplicated primary hypothyroidism. Avoid scope creep.

Throughout the document reference is made to ‘levothyroxine’ treatment. Whilst it is reasonable that levothyroxine is the recommended first treatment option the content should not be written in such a way that levothyroxine appears to be the only option. Doctors will not have time to study the whole document, they will use relevant bits. Replace ‘levothyroxine’ with ‘thyroid hormone supplements’. Increasing evidence of persistent signs and symptoms during levothyroxine monotherapy and the move towards personal medicine could obsolete levothyroxine monotherapy in the near future.

Testing for suspected thyroid dysfunction should include TSH, fT3 and fT4. TSH alone is insufficient. fT3 and fT4 assays cost 92p each. It is important to test all three hormones initially to confirm the hypothalamic pituitary thyroid axis is intact. Many patients are severely hypothyroid as a consequence of a down-regulated axis, see ibshypo.com/index.php/subno... . A record of TSH, fT3 and fT4 at initial diagnosis may prove invaluable, it would be tragic to miss this opportunity for the sake of a few pence. If the patient’s axis is functioning normally and TSH reflects their clinical response it is reasonable to use TSH for titration.

The recommendation that repeat testing should not be carried out within six weeks is sensible in most cases. However, worsening symptoms or erratically swings from hypo to hyper could be due to autoimmune flare ups. In such cases repeating tests sooner is needed for diagnosis and so consideration can be given to alternative options such as block and replace.

There are several references to using the TSH reference range (sic) as a diagnostic range or a therapeutic target. There is no evidence base for these statements. Many patients who have a TSH within the reference interval are hypothyroid. Some patients require a low TSH to resolve signs and symptoms of hypothyroidism. Some patients have a very narrow therapeutic range within the TSH reference interval. There is no evidence that biochemistry reflects clinical presentation in all cases. The guidance should assert the superiority of clinical response over biochemistry. Serum is the intermediate space; it does not consistently reflect intracellular hormone status. We need some good science.

Statement 1.3.5 regarding NDT is perverse. Whilst it shouldn’t be offered as a first line treatment (due to cost) there is a small number of patients who fail to respond to synthetic hormone. NDT has been prescribed continuously for over a century, long enough for physicians to decide whether it has long-term adverse effects. If there are concerns about T3 / T4 ratios combined NDT / levothyroxine therapy should be recommended.

The research into combined levothyroxine / liothyronine therapy is sloppy. Half the studies substitute L-T3 for L-T4 in a 1:4 or 1:5 ratio based on their relative serum potency. Of course, the ratio patients swallow is not reflected in the blood, due to different absorption rates and elimination half-lives. Researchers should have an elementary understanding of pharmacokinetics! All the studies fail to select appropriate cohorts – patients who fail to do well on levothyroxine. None of the studies attempted to determine the L-T3 dose patients required. The researchers decree that the patients must suffer from primary hypothyroidism (and no other form of hypothyroidism) and this must be corrected by small amounts of L-T3, contrary to clinical experience. Demanding patients respond according to unproven theory is bad science.

It is reasonable to offer Graves’ patients a choice between RAI and surgery. A minority of patients report life-changing consequences of RAI, they never recover a normal life. Recommending RAI as first line treatment conflicts with the recommendation for research number 4 ‘Long-term effectiveness and safety of radioactive iodine therapy’. NDT and RAI have a similar evidence base; NDT therapy can be stopped; RAI is definitive and has known cases of adverse outcome. A more balanced and rational approach to the two therapies is required.

We do not understand why a small group of patients do so badly after RAI treatment, but it is reasonable to keep all options open. From a physics point of view, it seems irrational to use a systemic therapy to treat a single diseased organ. Whilst most iodine accumulates in the thyroid radioactive T3 molecules attach to receptors and DNA response elements, a few atoms away from the DNA. Most cells can regenerate, except brain cells. We might expect cognitive impairment in patients receiving large doses of RAI. More caution should be exercised when recommending RAI treatment, until its consequences are understood, and safer RAI protocols are available. For these reasons I feel patients should be offered an informed choice between RAI or surgery.

Finally, the proposed guidelines are consolidating practices that have been discredited over the past two decades. They fail to address large-scale patient dissatisfaction with hypothyroidism therapy and restrict the options available to patient and physician.

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Thanks for that - much appreciated.

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Absolutely brilliant! Seems to cover all bases and presented in a concise and easy to read style. The only "Technical jargon" I had to look up was "scope creep"! :-)

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Jim, would it be OK to make a copy of this to show the doctor, or send to the endo (or someone in his department) who refused the referral from my surgery? Your full name and relevant experience and qualifications would also help - need to impress people like that. Perhaps pm me?

I would leave out the RAI section as it doesn't apply to me.

Thanks x

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It's in the public domain so you can use it. I don't have any medical qualifications.

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Yet more knowledge of the thyroid than many medics!

Just shows!

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Bravo jimh111 👏👏👏👏👏👏

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You've made a very good assessment of the proposed guidelines. It was bad enough before (Skinner and Peatfield et al).

Those who should know better actually know much less than those on this forum. They do not realise their guidelines are causing more monetary wastage to the NHS such as 'extras' to try to control disabling symptoms which the patient has by prescribing 'other than' thyroid hormones which don't work and are a waste of time.

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That's a point I want to raise when I reply directly to NICE. They specifically ask for comments on cost so we should make sure they are aware of the great expense of failing to diagnose and treat, they tend to just look at the cost of tablets.

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This makes depressing reading. We deserve better. Maybe I missed it, but I can’t see hashis mentioned anywhere - yet it is different to hypothyroidism and needs to be treated differently - this is a major concern of my endo.

The reference to T3 is depressingly familiar - no evidence, blah, blah...

Sigh. 🤸🏿‍♀️🥛

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I think all GPs and doctors have to 'actually' be taught - by being shown patients who are as yet, undiagnosed, complaining and they should also be reading and learning all about Clinical Symptoms and read this forum daily.

If they had the knowledge of Dr Skinner and Dr Peatfield, et al and especially the doctors who lost their Licence because they treated patients as Dr S and Dr P did we'd have no need for this forum at all.

I, for one, would not have had to undergo an op to 'remove a "web" from my throat" which I never had - (most probably an enlarged thyroid gland). Surgeon couldn't explain to me what he actually saw on a barium swallow - and you don't get the money you paid refunded. I also wouldn't have been told I had 'Acid Reflux' from another and given a prescription that made me feel worse. I told the GP some months later 'there's something seriously wrong with me and I will have to pay for a Full Body Scan". He persuaded me not to as I might be diagnosed with things Ididn't have!

'Nothing wrong at all' when he had a TSH result (amidst another 22 tests) of 95.4. and phoned to tell me 'all results are fine and you don't have any problems'. I could barely hold the phone by that time, so I cried. You know full well that there's something gone awry and you just haven't a clue what. Fortunately I had a blood test form and early a.m. had a test and another GP phoned and asked 'who gave you a blood test form? I said I ordered it myself. She said you have hypothyroidism - come and get a form. As if I could leave the house - thankfully I had someone to take me and TSH was 100.

You rely on the medical profession but it is some sort of guessing game it seems as regards to any 'thyroid'. Instead of symptoms being part of the diagnosis we are led along a path called 'TSH' without any consideration at all of disabling symptoms. We are apt to be given a prescription for the 'symptom' but not thyroid hormone replacements. Then afterwards when diagnosed when we feel even worse than before the diagnosis, we've to search the internet for assistance!!!!!

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One of the few occasions when it was important to take note of the TSH level and that doctor didn't even manage that!!!!

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"If they had the knowledge of Dr Skinner and Dr Peatfield, et al and especially the doctors who lost their Licence because they treated patients as Dr S and Dr P did we'd have no need for this forum at all."

Do you have or know where we can get details of what happened to those doctors and others, exactly why they were accused of malpractice or whatever it was, and what disciplinary action was taken, if any?

Might be useful if any other doctors etc try to argue that nobody was disciplined or lost their job or anything as a result of trying to treat patients according to their need instead of by the rules that are not supposed to be rules!

Maybe a new thread?

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I believe it was because they didn't follow the 'new' rules because (I believe) they thought it was wrong to rely on numbers from a blood test whilst ignoring clinical symptoms and also not to prescribe NDT or T3 i.e. give us options if not recovering on levo. Making patients wait until their TSH reached 10. Denied by the professionals that they were hypo because their TSH had not reached 10.

Re Dr Peatfield, if you can get 'Tears Behind Closed Doors' you will realise what doctors used to know and what they don't know at present. It is a marvellous as well as enlightening read.

Dr Skinner's staff have been collating all of the scientific evidence since his death and are hoping it can be published. I don't know how far they've got in sourcing sufficient monies to publish it.

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Yet that actually goes against the guidelines that say "The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient"

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Why then was T3 withdrawn - immediately from patients and without warning, leaving desperate patients searching for it.

Why was T3 withdrawn without at least a warning of several months.

Why was cheaper T3 not sourced? I believe it was because they had a perfect excuse to stop prescribing it and forcing people to take a replacement hormone which makes them feel worse.

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Exactly!

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Yikes. I found 2 on Amazon (USA) by searching with the title in double quotes. The first match is $212

amazon.com/Tears-Behind-Clo...

On the UK Amazon site, a used one is available for only 4.20 pounds (No monetary pound symbol on my US keyboard.) amazon.co.uk/Tears-Behind-C...

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The book 'Tears Behind Closed Doors' by Diana Holmes is also available to buy directly from Thyroid UK here thyroiduk.org/tuk/tuk_shop/...

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Page 31, lines 5 & 6 - definitions:

Subclinical hypothyroidism

TSH levels above the reference range, with FT4 within the reference range.

That means, you could have a TSH of 100 or more and a symptom list as long as your arm and it still be classed subclinical. Doesn't even encourage looking for other reasons such as antibodies to T4 or biotin or any other test interference. Or a pituitary issue.

And they don't bother to define hypothyroidism at all.

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Or, like me and many others, you could have a TSH of 0.01 with T3 and T4 within range, and be told you were overmedicated and would have to reduce your medication

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And they consistently misuse the term "subclinical" which literally means this: relating to or denoting a disease which is not severe enough to present definite or readily observable symptoms.

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I haven’t even read the guidance and I can imagine - from these comments - what my response will be. Is there a way that several of us .. even several hundred of us .. can get together to make a combined response, that will have a greater impact?

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The underlying point of it being that you need to listen to people who have the condition in order to treat the condition ..

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Hi Everyone

I have read the draft guidelines and, filled in the questionnaire, it is just a re-hash of the current guidelines. I think NICE should be made aware of all the patients who are forced to buy their treatment over the internet, putting themselves at possible risk. It makes my blood boil that patients are forced into this, when they should be being treated by the NHS. I wonder if they are aware of the number of patients who actually do this, as most of their info would come from GP's and Endo's, when a lot of patients are self medicating and keep it to themselves.

When they say there is no evidence of efficacy of T3 or NDT, surely, it would be best to contact the patients who take these alternative hormones to gather this information.

Kind regards

Sidd0001

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I also think that for many of us there is no evidence of the efficacy of T4 only, but they won't accept that argument. Many Drs and Endos are only looking at TSH now and not bothering about the T4 level. They all assume that the pituitary works as it should. Things are going to be worse not better judging by these guidelines.

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The only people who can say there is efficacy when taking T3 or NDT are those patients who recover their health through taking it. Those doctors who deny T3 or NDT to others have no right to make statements when the recovered patients are back to normal health.

The Professionals really have no Idea what Thyroid Hormone Resistance is or if it exists at all. That's why 'new' diseases were named, i.e. ME, Fibro and CFS. These were 'named' about ten years after the introduction of levo and blood tests. Obviously there were lots of complaints back then too when NDT was removed.

Some people can take an Aspirin, yet others have bad reactions to it. Our bodies aren't identical and the very .

teacherspet

Jnetti

Geogeor

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So right....I saw an endo recently who refuses to believe thyroid hormone resistance exists outwith, perhaps, a very narrow parameter/genetic test result. Yet, he could not offer an explanation when I asked him why it is that I am now taking 93.75mcg T3 with no symptoms of overmedication and with improved well-being.

Stutter, splutter....

He was determined to adhere to TSH monitoring......I gave him the excellent paper by Midgley, Toft et al......funnily I didn't hear any more about the importance of TSH!

His decision....I think it may be best if you stick with the status quo ...but that wouldn't be what I would advise! I just looked at him!

In other words ...you seem to be doing the right thing but I'm not going to admit it!

It strikes me that medics are afraid of a threatening "body" looking over their shoulders. I'm not surprised there is a shortage of GPs they are reined in so tightly that professional integrity has been all but lost. Having said that I'm not so sure some of them are capable of joining up all the dots anyway.

I've seen enough examples of poor medical care in my own family to cause me to be very wary!

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Looking at the disclaimer in the guidelines, it says this:

"...When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users . The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient..."

Due to the faults in the guideline how is it possible to take it "fully into account, alongside the individual needs, preferences and values of their patients"?

And another "Gem":

"Mortality and quality of life were agreed by the Committee to be the critical outcomes for this review. Important outcomes included cardiovascular morbidity, heart disease, arrhythmias, osteoporosis, impaired cognitive function, depression, experience of care, healthcare contacts, symptom scores, growth and TSH suppression."

I think they said somewhere that nobody died during the process of making the guidelines. They wouldn't dare die, that would put their results out of kilter!!!! :-/

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Lyn - Im a little confused - not difficult these days!!

Is what you are asking us to do the same as what the ITT campaign survey is? Ive already filled out and sent back that, as they too were saying they needed it as stake holders.

Do I need to do anything else?

Are the guidelines that they were pointing to the same ones as your link above or have they been updated again?

Sorry if Im being thick!! 🤦🏼‍♀️

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the link to that BTW is here:

docs.google.com/forms/d/e/1...

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I think it's something else, not quite sure myself, but we have till 10th July instead of tomorrow for the ITT one

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Both ITT and Thyroid UK are independently registered as stakeholders in the development of these guidelines.

NICE appear to prefer comments to be received via stakeholders. Both ITT and Thyroid UK are preparing their responses.

So the same but different!

Jnetti

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Lyn, I will reply directly to NICE. What concerns me is that there were no representatives from independent patient groups on the committee. The only hypothyroid patient representative (as far as I know) was Mary Newton (Cambridge BTF) and of course the BTF are aligned to the BTA. Was ThyroidUK asked to join the committee?

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Another item in my response:

Simplistically applying a dose of 1.6 microgram per kilogram, and taking into account available doses, could give an actual range of dosing from 1.25 to 2.0 microgram per kilogram. This comes from combining available tablet dosages and decisions over rounding. (The 12.5 microgram tablet available from Teva has been ignored for two reasons – it is only available from that one company and it is significantly more expensive. These calculations are intended to illustrate the issue rather be a definitive statement.)

Table of actual dosing based on 1.6 microgram per kilogram dosing – rounded down to nearest tablet.

Weight Calculated Dose Actual dose

dose (rounded down) per kg

40 64 50 1.25

50 80 75 1.5

60 96 75 1.25

70 112 100 1.42

80 128 125 1.56

90 144 125 1.38

100 160 150 1.5

110 176 175 1.59

Table of actual dosing based on 1.6 microgram per kilogram dosing – rounded up to nearest tablet.

Weight Calculated Dose Actual dose

dose (rounded up) per kg

40 64 75 1.87

50 80 100 2

60 96 100 1.66

70 112 125 1.78

80 128 150 1.87

90 144 150 1.66

100 160 175 1.75

110 176 200 1.81

Availability and costs from: bnf.nice.org.uk/medicinal-f...

That is, whilst recommending what appears a very precise dosing the interpretation of that into actual prescribing behaviour gives a very different picture.

In fact, the 1.6 microgram per kilogram recommendation is unachievable and is a pretence of precision dosing.

[ Alignment of columns above fails when pasted and posted onto HU, I am sorry to say. ]

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OK folks - 50 points later and I have run out of steam.

Please feel free to read or ignore the linked document. I would prefer you not to copy words exactly as written just so that NICE do not have the excuse of suggesting we got together and copied each other directly. Add you own comments, references. Say what YOU want to say.

dropbox.com/s/9nuw8x0g3vht1...

jimh111

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Hi Lyn, I sent and filled in their comments form but am still trying to edit my comment for sending to you (Hashimoto's slow brain!) It keeps getting longer and today is the deadline! What is the latest I can send, and do you want an attachment or put it in the body of the email?

Thanks x

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Hi Jnetti, I'm afraid I won't be able to add all comments in. I will be taking the important points from everyone's comments though. I need them by 5pm tomorrow. Putting into the body of the email is fine. thanks!

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Sent yesterday evening. Expect you have many comments to sort over :-O

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Also, is it best to be almost completely factual or talk about one's own experience of thyroid issues as relevant to the guidelines?

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Both, really....

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