Dear curriculum creators and top docs,
As a medic with published research on Restless Legs Syndrome (RLS), I raise a number of concerns and some possible solutions , which have largely been endorsed by ******* Education Policy, GMC, who recommends that I contact you with these concerns to enable change and improvement in the diagnosis and management of RLS. These concerns plus some solutions are :
1.Improve Education of Medical Personnel about RLS.
2.Concise Training Material for RLS
3.(i)Intravenous Iron should be the First Line Treatment for most patients with Moderate and Severe RLS.
3(ii) The need to establish an evidence-based limit value for serum ferritin in the use of intravenous iron for Restless Legs Syndrome
4.To really pay attention to the thoughts and aims of ******* GMC Education Policy,
5.The Case Report on Repeat Treatment of RLS with Intravenous Infusion of Iron
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It seems likely to me , that YOU will encounter opposition about:
a) the use of I-v iron for safety reasons. (Though anaphylaxis is very uncommon with the new stable formulations such as ferric carboxymaltose , (~ 0.3-2.5 per 10,000) and b) reduction of , or stopping prescription of Dopamine agonists as first line treatment in the U.K. with its likelihood of causing augmentation sooner or later.
Please check out the science and not be too swayed by out of date views when the good quality latest research is done largely in the U.S.A.
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CONCERNS and some SOLUTIONS
1.Improve Education of Medical Personnel about RLS.This disorder affecting some 10% of the population has inappropriately been ignored in the curriculum for medical training. It is proposed that this omission be addressed. There is an urgent need for improved education of medical personnel, patients and carers regarding Restless Legs Syndrome
The European Federation of Neurological Associations (EFNA) launched a vital survey—--see
urldefense.com/v3/__https:/...
OR--see/google EFNA ‘Assessing diagnosis and care pathways of people living with neurological disorders in Europe‘ in February 2022.
This survey has been developed with the aim of identifying, reporting and beginning to address the varied challenges facing all affected by neurological conditions, either as patients or caregivers, from diagnosis to care pathway.
2.Concise Training Material for RLS ******also wrote ‘Your idea to develop concise training material will help to bring consistency in essential knowledge on this topic.
“The BARE BONES of Restless Legs Syndrome’ or similar 1-10 points…… = CONCISE TRAINING MATERIAL.My feeling is that it is necessary for those who write the neurology educational curriculum, to adapt this document called something like…. ’The BARE BONES of RESTLESS LEGS SYNDROME handout’ see BB Document below, should be given at the 1st consultation with a doctor, usually the GP. However, ****** informed me that the specific content of each postgraduate specialty curriculum is determined by the relevant medical royal college or faculty. This, TO ME, does seem a bit of a waste of man power, time and money ——, that every university , possibly for reasons of competition rather than for what is absolutely the best medicine plans the curriculum, when a committee made up from one neurologist (with an interest in education) from each University would be a better solution to produce a national curriculum which can allow for some flexibility/nuances of management as is the ’Art of Medicine’ over Millennia.
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Bare Bones RLS Document
1. Doctor should listen well, give empathy and a compassionate attitude and very focussed history taking, leading to:
2. Consideration of differential diagnostic red flags, separate from or possibly associated with RLS—see-n.neurology.org/content/neu...
3. Assess the degree of severity - mild, moderate or severe
4. Moderate/severe subjects, arrange for a blood test, general parameters, fbc, CRP, blood glucose, TFTs) plus an ‘iron’ panel. Fasting iron, TIBC or transferrin, ferritin and TSAT as a percentage
5. Suggest patients fill out/keep a record of the IRLSSG Rating scale, at least all moderate/severe subjects for 4-6 weeks —
see—
biolincc.nhlbi.nih.gov/medi...
6. Give all mild/moderate/severe subjects this (or similar) ‘Bare Bones RLS’ handout improved on/written by the ‘Curriculum Creators’ which will include signposting to :(i)The excellent recent webinar by Professor Chris Earley —see-
(ii)The Best document for overall management of RLS…..
The Management of Restless Legs Syndrome : An Updated Algorithm
urldefense.com/v3/__https:/...
(iii)The above Mayo Updated Algorithm, but hopefully slightly altered following discussion of ‘The need to establish an evidence-based limit value for serum ferritin in the use of intravenous iron in the treatment of RLS’ letter (see Letter* at end of email)
(iv)The research projects in the USA. particularly Professor Chris Earley at Johns Hopkins, Baltimore, Maryland, USA, Also maybe Dr. Mark Buchfuhrer MD FRCP© FCCP Medical Director of the Southern California Support Group , RLS-UK —-
see- rls-uk.org/
(vi) Health Unlocked forum —
see- healthunlocked.comHealthUnl...
(vii) serious consideration of safe use of methadone and buprenorphine.
(viii) regular, prompt updating of the results of U.K. research projects Patients can take it home, stick it on their fridge door and read and study it over the coming weeks, probably when they are stamping around at 2am, unable to sleep!
7. Give follow up appointment for 4-6 weeks for moderate/severe subjects to check their rating scale results, discuss their blood test results and discuss their treatment options (and BB handout describing all potential aggravating factors and drugs ,prescribed or OTC).
8. For moderate/severe RLS sufferers, most should have intravenous iron as first line treatment. *see discussion below.
9. For those with mild disease should still receive the handout and be told to make another appointment if the condition worsens (+ blood test etc. if possibly anaemic or other diagnoses).
10. For moderate or severely affected patients— FULLY discuss treatment options - intravenous iron, alpha 2 delta ligands, opioids, methadone and only if absolutely necessary……………… and after logical, careful treatments by doctors, and failure of these treatments, and probable subsequent referral to secondary care or incredibly careful monitoring of the possibility of development of augmentation. Only then, and way down the order, prescribe Dopamine agonists!
—This ‘handout’ or similar, should form the basic ‘Bare Bones’ of RLS education and used in all medical schools, in GP training, for trainee neurologists, consultant neurologists and obviously for patients and caregivers and interested relatives and general public.
EVERYONE SHOULD KNOW WHAT IS EXPECTED FROM THE FIRST CONSULTATION WITH MEDICAL PERSONNEL.
It will not complete the whole personal plan but (i) they will feel listened to and (ii) they can see that they are at least on the way to caring and compassionate help with their Restless Legs Syndrome.
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3.(i) Intravenous Iron should be the First Line Treatment for most patients with Moderate and Severe RLS, pretty much as per the
‘The Management of Restless Legs Syndrome : An Updated Algorithm’ :—see—mayoclinicproceedings.org/a...
But please reconsider the sentence — Ferric carboxymaltose (1000 mg) is effective for treating moderate to severe RLS in those with serum ferritin <300 μg/l.
(ii) Dispel the fallacious fear of ferritin, but not the sensible consideration of ferritin levels, TSATs etc.The need to establish an evidence-based limit value for serum ferritin in the use of intravenous iron for Restless Legs Syndrome. (see attachment of letter in press... Letter to Editor Sleep Journal)
4. The Case Report on Repeat Treatment of RLS with Intravenous Infusion of Iron
—see
Medical Case Report on Repeat Treatment of Restless Legs Syndrome with Intravenous Infusion of Irondoi.org
Comment by ****** : I appreciate the extra detail you have included that reinforces the case for doctors to be trained in intravenous iron therapy as a crucial intervention for moderate and severe RLS.
5.To really pay attention to the thoughts and aims of ****** at GMC Education Policy, (some direct quotes )
-I encourage you to continue your efforts to promote the evidence with others who are better placed to influence the detail of curricula at different stages of education
– the contacts i.e. the Medical Schools Council,(MSC), the relevant royal colleges, and the four statutory education bodies of the UK. Key organisations to influence training are the Royal College of Physicians and the Association of British Neurologists who, with expert clinical knowledge and research, have a key role in promoting neurological education throughout all levels of medical training.
-Health Education England run the—see-e-Learning for Healthcare platform which showcases online training, and they are sometimes able to fund the development of new training materials. HEE can advise on whether they would contribute to a comprehensive resource on the recognition and management of RLS that could be targeted at different levels of practice.
-Another piece of work that may be of interest is that we have commissioned the Academy of Medical Royal Colleges (AoMRC) to identify and develop areas where key learning can be shared in postgraduate training across specialties. -
-AoRMC are working with colleges to create a suite of shared learning content on areas that cut across different areas of medicine, and that specialties can tailor to their own needs. As RLS cuts across different specialties, it may be a good candidate for shared learning – once a process has been established. The process to identify and develop shared learning across specialties will consider post-qualification development as part of a programme of lifelong learning across a doctor’s career, with the aim of improving the skills of doctors who are out of training and already practising. We can keep an eye on this and work with AoMRC to determine if RLS could be a shared learning topic-
-The Medical Schools Council (MSC) have oversight of all medical schools. They run an advisory group which brings together education leads from all schools and clinical experts to share information and best practice around undergraduate training and curricula. They may be able to help in enhancing education on RLS in undergraduate curricula and bringing consistency across schools.
. -Apart from this we’ll ensure we include RLS in the next proposal to update the MLA content map and put forward your evidence around this when communicating with our stakeholders.-------------------------------------------------------- -Your idea to develop concise training material will help to bring consistency in essential knowledge on this topic.--------------------------------------------------------------The GMC set standards which describe how doctors should behave, but we don’t set the content of medical curricula for undergraduate or postgraduate training. Our powers in medical education, as set out in the Medical Act 1983, are two-fold: to set the outcomes for graduates of UK medical schools leading to entry on to the medical register, and to approve the curricula for postgraduate training of doctors.-------------------------------------------- -We quality assure both aspects of medical training against our standards for the management and delivery of medical education and training. ---------------------------------------------- Our Outcomes for graduates describe the broad skills and knowledge that are required of medical students in order to graduate, but not the detail of the curriculum. -We have no powers to direct the specific content of medical school curricula, which is a matter for the individual medical schools across the UK, as part of the independent universities sector.-However, schools must demonstrate to us that they meet both the high-level outcomes and our standards.-We make periodic visits to medical schools as part of our quality assurance process to ensure that our statutory requirements are met. ---------------------------------------------------RLS isn’t explicitly included in Outcomes for graduates, ----------------------------------Assessment-The GMC are introducing a new way of assessing final year students: the Medical Licensing Assessment (MLA). The MLA will be introduced in the academic year 2024-25 and for all students from 2024. -All medical students will need to pass the MLA before joining the medical register.---------------------------------------------The GMC have published a content map which sets out areas of medicine that could be tested during the assessment. --------------------------------------------During the GMC’s engagement and consultation with stakeholders while developing the content map, RLS wasn’t proposed as a specific patientPresentation-----------------------------------------------The GMC expect schools to develop and deliver a curriculum which prepares students for the MLA and to handle the demands of practice as newly registered doctors. The GMC would be glad to include links to any resources published to support medical schools in teaching RLS.---------------------------------------------------The GMC will also take RLS for consideration to include explicitly in the next iteration of the content map. ----------------------------------------------------However, the specific content of each postgraduate specialty curriculum is determined by the relevant medical royal college or faculty.--------------------------------------------------The GMC prospectively review and approve these curricula against our standards.---------------------------------------------------Doctors in training must demonstrate capabilities in: history taking, diagnosis and medical management; dealing with complexity and uncertainty; keeping knowledge up to date; demonstrating empathy and compassion----------------------------------------------Included in the core medical curriculum, which all specialty trainees must complete, are disorders of the nervous system, involuntary movements, abnormal sensation, and neuropathic pain. All doctors must know how to recognise and manage these. ------------------------------------------------- RLS is not explicitly mentioned in the Neurology curriculum
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See Letter* THE NEED TO ESTABLISH AN EVIDENCE-BASED LIMIT VALUE FOR SERUM FERRITIN IN THE USE OF INTRAVENOUS IRON IN THE TREATMENT OF RLS
Dear Editor,
I am writing to highlight to the community involved in the research and management of Restless Legs Syndrome (RLS), the need for some clarity and an evidence-based rationale for the selection of a “cut off” value of serum ferritin concentrations in the decision regarding the useof intravenous (IV) iron infusion in the treatment of RLS.
In the excellent recent article by Allen et. al. [1], much useful information on clinical practice guidelines for RLS was provided. This included the need to ensure that transferrin saturation remained below 45% as a requirement for recommending iron infusion therapy, with which I fully concur.
It has also been noted that this therapy may be beneficial for people with RLS without low iron (as long as there is no iron overload) [2]
However, there appears to be considerable uncertainty and potentially confusion as to what should be considered a reasonable and safe level of serum ferritin below which iron infusion therapy can be recommended.
Allen and colleagues [1] conclude: “Nonetheless, given the lack of significant experience with higher serum ferritin levels the expert-based recommendations are to limit the initial IV iron treatment to patients with serum ferritin levels ≤ 100 µg/l”.
On the basis of this publication, this cut off value has been taken up in the recommendations and algorithm published in the Mayo Clinic Proceedings [3]:
“According to a consensus of RLS experts, the base requirement for any use of intravenous iron therapy in RLS is that the serum ferritin concentration should be less than 100 μg/L”
It is not clear, however, what factors have led to this cut-off value of ≤ 100 µg/l and whether it might be considered too conservative.
Allen et. al., [1] recognise the following:“Ferric carboxymaltose 1000mg is considered effective for the treatment of moderate to severe RLS in patients with a serum ferritin 300 µg/l or transferrin saturation >45%”Serum ferritin from 300-1000 µg/l is generally used as an alert because this can be indicative of underlying disease.
In the case of deliberate IV iron, the elevation of ferritin is intentional. The risk of hepatic iron overloadhas been reported as being low with serum ferritin concentrations below 1000 µg/l [4,5,6]. There is a risk of fibrosis and cirrhosis above this threshold of 1000 µg/l [7]. All haemachromatosis subjects with either hepatic fibrosis or cirrhosis had ferritin concentrations greater than 700micrograms/L” [8].
A recommended serum ferritin cut-off value for initial and subsequent iron infusions should be evidence-based and reconsidered taking the above considerations into account with enhanced collaboration between neurologists and haematologists.
References [1] Allen PA, Picchietti DL, Auerbach M, Cho YW, Connor JR, Earley CJ, Garcia-Borreguero D, Kotagal S, Manconi M, Ondo W, Ulfberg J and Winkelman JW.International Restless Legs Syndrome Study Group(IRLSSG) (2018) Evidence-based and consensus clinical practice guidelines for the iron treatment of restless legs syndrome/Willis-Ekbom disease in adults and children: an IRLSSG. Sleep Medicine 41, 27-44.
[2] Gossard TR, Trotti LM, Videnovic A. St Louis EK.(2021) Restless legs Syndrome: Contemporary Diagnosis and Treatment. Neurotherapeutics 18 (1) 140-155
[3] Silber MH, Buchfuhrer MJ, Earley CJ, Koo BB, Manconi M, Winkelman JW (2021) Scientific and Medical Advisory Board of the Restless Legs Syndrome Foundation. The Management of Restless Legs Syndrome: An Updated Algorithm. Mayo Clin Proc.96(7):1921-1937
[4] Allen KJ, Bertalli NA, Osborne NJ, Constantine CC, Delatycki MB, Nisselle AE, et al. (2010) HFE Cys282Tyr homozygotes with serum ferritin concentrations below 1000 microg/L are at low risk of hemochromatosis. Hepatology.52:925–33 [5] Olynyk JK, Gan E, Tan T.(2009) Predicting iron overload in hyperferritinemia. Clin Gastroenterol Hepatol. 7:359–62
[6] Chin J, Powell LW, Ramm LE, Ayonrinde OT, Ramm GA, Olynyk JK. (2019) Utility of hepatic or total body iron burden in the assessment of advanced hepatic fibrosis in HFE hemochromatosis. Sci Rep. :20234
[7] Goot K, Hazeldine S, Bentley P, Olynyk J, Crawford D.(2012) Elevated serum ferritin ‒ what should GPs know? Aust Fam Physician. 41:945–9
[8] Bassett ML, Halliday JW, Ferris RA, Powell LW.(1984) Diagnosis of hemochromatosis in young subjects: predictive accuracy of biochemical screening tests. Gastroenterology. 87(3):628-633
Reference to the updated "Algorithm" for RLS treatment
New take on RLS from a physical theapist point of view..
Ferratin Level BS!
