BMJ 2014;349:g5701 doi: 10.1136/bmj.g5701 (Published 8 October 2014) Page 1 of 6 Practice PRACTICE GUIDELINES Multiple sclerosis: summary of NICE guidance 1 1 Mark Perry senior research fellow , Sharon Swain senior research fellow , Sophia Kemmis-Betty 1 health economist , Paul Cooper chair of guideline development group, consultant neurologist, 23 honorary senior lecturer , on behalf of the Guideline Development Group National Clinical Guideline Centre, Royal College of Physicians, London NW1 4LE, UK; 2Neurology Department, Salford Royal Foundation Trust, Salford, UK; 3Department of Medicine, University of Manchester, Manchester, UK 1 This is one of a series of BMJ summaries of new guidelines based on the best available evidence; they highlight important recommendations for clinical practice, especially where uncertainty or controversy exists. Multiple sclerosis (MS) is the most common cause of serious physical disability in working age adults and affects over 100 000 people in the United Kingdom.1 It causes a range of symptoms and disability and requires a broad multidisciplinary approach. A 2008 report, however, suggested delays and limited access to specialist services for affected people.2 This article summarises the most recent recommendations from the National Institute for Health and Care Excellence (NICE).3 The guideline scope does not include disease modifying drugs as these have been covered in other NICE guidance. Recommendations NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the guideline development group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italics in square brackets. Diagnosing multiple sclerosis • MS should be diagnosed only after careful assessment by a consultant neurologist, using the McDonald4 criteria (table⇓). The criteria include the need to rule out alternative diagnoses, and clinical judgment is often required to consider these and decide on what is, or is not, an attack. • The diagnosis should not be made on the basis of the results of magnetic resonance imaging alone. Be aware that common clinical presentations include: -Loss or reduction of vision in one eye with painful eye movements -Double vision -Ascending sensory disturbance or weakness, or both -Problems with balance, unsteadiness, or clumsiness -Altered sensation travelling down the back and sometimes into the limbs when the patient bends the neck forwards (Lhermitte’s symptom). • As well as these symptoms, people with MS: -Are often aged under 50 and -Might have a history of previous neurological symptoms and -Often have symptoms that have evolved over more than 24 hours, which persist over several days or weeks and then improve. • [Based on the experience and opinion of the guideline development group (GDG)] • Do not consider MS if the main symptoms are fatigue, depression, or dizziness, unless there is a clear history or evidence of focal neurological symptoms or signs. Before a person is referred to a neurologist the following tests are recommended to exclude other diagnoses: -Full blood count -Inflammatory markers -Renal and liver function -Serum calcium concentrations -Blood glucose concentrations -Thyroid function -Serum vitamin B12 concentrations -HIV serology. • [Based on the experience and opinion of the GDG] • Refer people suspected of having MS to a consultant neurologist. Speak to the consultant neurologist if you think Correspondence to: M Perry [email protected] For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe BMJ 2014;349:g5701 doi: 10.1136/bmj.g5701 (Published 8 October 2014) Page 2 of 6 PRACTICE a person needs to be seen urgently. [Based on the experience and opinion of the GDG] • If a person is suspected of having MS but does not fulfil the diagnostic criteria, plan a review. Discuss the timing of the review with the person and ensure they know who to contact for advice if they develop further neurological symptoms or if current symptoms worsen. [Based on the experience and opinion of the GDG] (table⇓) • The consultant neurologist should ensure that the person with MS and (if they agree) their family members or carers are offered oral and written information at the time of diagnosis. This should include, but not be limited to, information about: -What MS is -Treatments, including those to modify the disease -Symptom management -How support groups, local services, social services, and national charities are organised and how to get in touch with them -Legal requirements such as notifying the DVLA (Driver and Vehicle Licensing Agency) and legal rights including social care, employment rights, and benefits. • [Based on moderate to high quality qualitative evidence] • Discuss with the person with MS and their family members or carers whether they have social care needs and if so refer them to social services for assessment. Ensure the needs of children of people with MS are dealt with. [Based on moderate to high quality qualitative evidence] Coordination of care • Care for people with MS by using a coordinated multidisciplinary approach. Involve professionals who have experience in managing MS and its symptoms and complications including: -Consultant neurologists -MS nurses -Physiotherapists and occupational therapists -Speech and language therapists, psychologists, dieticians, social care and continence specialists -General practitioners (GPs). • [Based on low quality observational studies and qualitative studies] • Offer the person with MS an appropriate single point of contact to coordinate care and help them to access services. [Based on low quality quantitative and qualitative evidence] Comprehensive review • Undertake a comprehensive review of all aspects of each person’s care at least once a year. Review should be carried out by healthcare professionals with expertise in MS and its complications. Different healthcare professionals with expertise in specific issues of the review should be involved as needed. [Based on the experience and opinion of the GDG] • Tailor the comprehensive review to the person’s needs, assessing: -MS symptoms: -Mobility, balance, and falls For personal use only: See rights and reprints http://www.bmj.com/permissions -Use of upper limbs -Muscle spasms, stiffness, and tremor -Need for mobility aids including wheelchair assessment -Bladder, bowel, and sexual function -Sensory symptoms and pain -Speech and swallowing -Vision -Cognitive symptoms -Fatigue, depression, anxiety, and sleep patterns -Respiratory function—for example, clinical findings of raised respiratory rate or complaints of shortness of breath -The MS disease course: -Relapses in the last year -General health: -Weight -Smoking, alcohol, and recreational drugs -Exercise -Access to routine health screening and contraception -Care of other chronic conditions -Social activity and participation: -Family and social circumstances -Driving and access to transport -Employment -Access to daily activities and leisure -Care and carers: -Personal care needs -Social care needs -Access to adaptations and equipment at home • [Based on the experience and opinion of the GDG] The timing of these reviews needs to be sensitive to individual needs: • Review drugs, bone health,5 and risk of contractures regularly, and review areas at risk of pressure ulcers at every contact.6 [Based on the experience and opinion of the GDG] • Refer any identified issues to appropriate healthcare professionals for management. [Based on the experience and opinion of the GDG] • When appropriate, refer to palliative care services for symptom control and for end of life care. [Based on the experience and opinion of the GDG] Relapses and exacerbations • People with MS can experience relapses, which are the onset of new symptoms. The term exacerbation is also used to describe a relapse involving the considerable worsening of existing symptoms (box). Both are treated in the same way. Relapses are typified by occurring: -For a duration of more than 24 hours -In the absence of infection or any other cause -After symptoms have been stable for at least one month. • [Based on the experience and opinion of the GDG] Subscribe: http://www.bmj.com/subscribe BMJ 2014;349:g5701 doi: 10.1136/bmj.g5701 (Published 8 October 2014) Page 3 of 6 PRACTICE Definitions of terms relating to symptoms of multiple sclerosis • Relapse—New signs and symptoms caused by a new focal demyelinating lesion in the central nervous system that usually resolves, partially or completely, within days to weeks • Exacerbation—A worsening of existing signs and symptoms because of a focal demyelinating lesion in the central nervous system that usually resolves, partially or completely, within days to weeks • Fluctuations—Transient changes in symptoms that do not represent a relapse or progression of disease. A common cause of fluctuations is increased heat, such as that encountered in a hot bath • Disease progression—An accumulation of disability, which can be continuously progressive or stepwise (after acute deteriorations which do not fully recover) • Local guidance and care pathways are needed for the timely treatment of relapses, and it is important to ensure that the pathway includes appropriate follow-up. Not all relapses need treatment with steroids, so a non-specialist should discuss whether to offer steroids with healthcare professionals with experience in MS. [Based on the experience and opinion of the GDG] • Before a relapse can be diagnosed, infection should be ruled out—particularly urinary tract and respiratory infections—and discrimination made between relapse and fluctuations in disease or progression (see box for definitions). [Based on the experience and opinion of the GDG] • Assess and offer treatment for relapses of MS that affect normal function as early as possible, and certainly within 14 days of symptom onset. If the new symptoms have been present for more than three months, this is unlikely to represent an acute relapse and probably reflects disease progression, so do not treat with steroids. [Based on the experience and opinion of the GDG] Treating a relapse • Offer treatment for relapse of MS with oral methylprednisolone 0.5 g daily for five days. [Based on very low to low quality evidence from randomised controlled trial] • Consider intravenous methylprednisolone 1 g daily for three to five days as an alternative for people with MS: -In whom treatment with oral steroids has failed or not been tolerated, or -Who need admitting to hospital for a severe relapse or monitoring of medical or psychological conditions such as diabetes or depression. • [Based on very low to low quality evidence from randomised controlled trial] • Do not prescribe steroids at lower doses than methylprednisolone 0.5 g daily for five days to treat an acute relapse. [Based on the experience and opinion of the GDG] • Do not give people with MS a supply of steroids to self administer at home for future relapses. [Based on the experience and opinion of the GDG] Pharmacological management of symptoms Mobility • Do not use fampridine to treat lack of mobility as it is not cost effective. [Based on very low to low quality evidence from randomised controlled trials and cost effectiveness analysis] This recommendation does not apply to people who have already started treatment with fampridine, who For personal use only: See rights and reprints http://www.bmj.com/permissions should be able to continue treatment until they and their clinicians think it appropriate to stop. Fatigue • Assess and offer treatment for contributing causes to fatigue, such as anxiety, depression, difficulty in sleeping, and any coexisting medical problems such as anaemia or thyroid disease. [Based on the experience and opinion of the GDG] • Offer amantadine to treat fatigue [Based on moderate quality evidence from randomised controlled trials] but do not use vitamin B12 injections as there is no evidence for their benefit in the treatment of MS. Spasticity • Assess and offer treatment for factors that could aggravate spasticity, such as constipation, infections, inappropriately fitted mobility aids, pressure ulcers, posture, and pain. [Based on the experience and opinion of the GDG] • Encourage people to manage their own spasticity symptoms by explaining how doses of drugs can be adjusted within agreed limits. [Based on the experience and opinion of the GDG] • Ensure that the person: -Has tried the drug at an optimal dose, or the maximum dose they can tolerate -Stops a drug if there is no benefit at the maximum tolerated dose -Has their drug treatment reviewed at least annually. • [Based on the experience and opinion of the GDG] • Consider baclofen or gabapentin as a first line drug to treat spasticity, depending on contraindications and the person’s comorbidities and preferences. [Based on very low to low quality evidence from randomised controlled trials] Consider combining these drugs if they provide inadequate relief alone, or side effects from individual drugs prevent the dose being increased. [Based on the experience and opinion of the GDG] • Consider tizanidine or dantrolene as a second line option, and benzodiazepines as a third line option. [Based on very low to high quality evidence from randomised controlled trials] • Do not offer Sativex (a synthetic cannabis extract) to treat spasticity in people with MS as it is not cost effective. [Based on low to high quality evidence from randomised controlled trials and cost effectiveness analysis] This recommendation does not apply to people who have already started treatment with Sativex, who should be able to continue treatment until they and their clinician think it appropriate to stop. Subscribe: http://www.bmj.com/subscribe BMJ 2014;349:g5701 doi: 10.1136/bmj.g5701 (Published 8 October 2014) Page 4 of 6 PRACTICE • If treatments are unsuccessful, refer the person to specialist spasticity services. [Based on the experience and opinion of the GDG] -The risk of the child developing MS -Use of vitamin D before conception and during pregnancy -Drug use in pregnancy -Pain relief during delivery (including epidurals) Treatment programmes for symptoms • Ensure people have access to a comprehensive assessment to establish individual goals and discuss ways to achieve them. This would usually involve rehabilitation specialists and physiotherapists with expertise in MS. [Based on very low to low quality evidence from randomised controlled trials] • For mobility problems and fatigue related to MS, consider supervised exercise programmes involving moderate progressive resistance training and aerobic exercise. [Based on very low to low quality evidence from randomised controlled trials] • Consider mindfulness based training, cognitive behavioural therapy, or fatigue management for treating fatigue related to MS. [Based on very low to low quality evidence from randomised controlled trials] • Consider referring people with persisting memory or cognitive problems to both an occupational therapist and a neuropsychologist to assess and manage these symptoms. [Based on the experience and opinion of the GDG] Other issues • Do not offer vitamin D and omega 3 or omega 6 fatty acid compounds solely to treat MS because there is lack of evidence of effectiveness. [Based on very low to high quality evidence from randomised controlled trials] Vaccinations • Be aware that live vaccinations might be contraindicated in people with MS who are receiving disease modifying treatments. [Based on the experience and opinion of the GDG] • Discuss with the person with MS: -The possible benefits of flu vaccination and -The possible risk of relapse after flu vaccination if they have relapsing-remitting MS. [Very low quality evidence from randomised controlled trial] • Offer flu vaccinations to people with MS in accordance with national guidelines, which recommend an individualised approach according to the person’s needs. [Based on the experience and opinion of the GDG] Pregnancy • Explain to women of childbearing age with MS that: -Relapse rates might reduce during pregnancy and can increase three to six months after childbirth before returning to pre-pregnancy rates [Based on low to moderate quality evidence from cohort study] -Pregnancy does not increase the risk of progression of disease. [Based on low to moderate quality evidence from cohort study] • If a woman with MS is thinking about pregnancy, give them the opportunity to talk with a healthcare professional with knowledge of MS about: -Fertility For personal use only: See rights and reprints http://www.bmj.com/permissions -Care of the child -Breast feeding. • [Based on the experience and opinion of the GDG] Overcoming barriers Ensuring that all members of the multidisciplinary team have adequate expertise in MS could lead to the need for further training, which has cost implications. Furthermore, the recommendation that the person with MS is given a single point of contact with the multidisciplinary team might prompt adaptation of roles where such a service does not already exist. For example, the single point of contact will need to provide information and advice and have efficient channels of communication with other members of the team and external services. The recommendation for regular comprehensive reviews might also necessitate expansion of services as such reviews are likely to highlight more needs of patients and carers than would previously have been identified, as well as the need for more coordinated working of the multidisciplinary team. The recommended local guidance and pathways for timely treatment and follow-up of relapses might not be common practice in some areas, but development of these should improve contact and communication between different healthcare professionals. Finally, the recommendation to refer to palliative care services for symptom control and for end of life care might require new links with these services, as well as further training in recognising the need for referral. The members of the guideline development group were: Lola Adedokun, Noreen Barker, Pamela Bostock, Peter Brex, Jeremy Chataway, Krishna Chinthapalli, Paul Cooper (chair), Elisabetta Fenu, Sarah Gillanders, Aleks de Gromoboy, Lina Gulhane, Wendy Hendrie, Ann Hodgson, Susan Hourihan, Amy Kelsey, Sophia Kemmis-Betty, David Kernick, Kate Lovibond, Paul Riordan-Eva, Emma Rowe, Sharon Swain, Norma O’Flynn, Mark Perry, and Richard Warner. Contributors: All four authors (MP, SC, SKB, PC) made substantial contributions to the conception or design of the work or the acquisition, analysis, or interpretation of data for the work; drafted the work or revised it critically for important intellectual content; approved the final version to be published; and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. MP is guarantor. Competing interests: We have read and understood the BMJ policy on declaration of interests and declare the following interests: PC has stocks in pharmacological companies but these are managed by a third party and PC does not believe any of the companies are associated with drugs mentioned in this guideline. The authors’ full statements can be viewed at www.bmj.com/content/bmj/349/bmj.g5701/related# datasupp. Provenance and peer review: Commissioned; not externally peer reviewed. 1 2 Mackenzie IS, Morant SV, Bloomfield GA, MacDonald TM, O’Riordan J. Incidence and prevalence of multiple sclerosis in the UK 1990-2010: a descriptive study in the General Practice Research Database. J Neurol Neurosurg Psychiatry 2013;85:76-84. National Audit of Services for People with Multiple Sclerosis 2008: full report. Royal College of Physicians, 2008. www.rcplondon.ac.uk/sites/default/files/ms-audit-2008-full-report_1. pdf. Subscribe: http://www.bmj.com/subscribe BMJ 2014;349:g5701 doi: 10.1136/bmj.g5701 (Published 8 October 2014) Page 5 of 6 PRACTICE Further information on the guidance In 2008 the Royal College of Physicians and MS Trust2 conducted an audit into MS services throughout England and Wales. This report suggested that services for people with MS were not optimal. Among other findings, the report indicated that half of all people with MS had to wait at least 20 weeks from GP referral to diagnosis, 40% of patients with a new diagnosis were not seen by a neurologist within six weeks, and only a third of people with MS thought that they had access to specialised neurological rehabilitation services. The current NICE guidelines were set up to deal with these concerns, and the guideline development group have made several new recommendations that could help to improve services. These include the need for services to be coordinated through an expert multidisciplinary team, one of whom should be a single point of contact for the person with MS. In addition, it has been recommended that structured comprehensive reviews should occur at a minimum frequency of one year, local guidance and pathways should be set up for relapse management, and referral to palliative care services should be possible. The guideline was developed according to NICE guideline methods (www.nice.org.uk/article/PMG6/chapter/1%20Introduction#/#nice-clinicalguidelines). This involved stakeholder consultation to define the scope of the guideline, followed by GDG developmental work involving systematic searching, critical appraisal, and synthesis of the clinical and cost effectiveness evidence within the scope. New cost effectiveness analyses were also undertaken (fampridine for mobility, and supervised or home based resistance and balance training for mobility and fatigue). The GDG consisted of clinical, technical, and lay members, including patient representatives, MS nurses, neurologists, physiotherapists, occupational therapists, systematic reviewers, health economists and information scientists. NICE has produced four different versions of the guideline: a full version; a pathway; a version known as the “NICE guideline” that summarises the recommendations; and a version for patients and the public (www.nice.org.uk/Guidance/CGXXX/InformationForPublic). All these versions are available from the NICE website. Updates of the guideline will be published according to the NICE guideline development programme. The guideline’s research recommendations consider remaining uncertainties, particularly regarding: • The most effective type of cognitive rehabilitation • The best pharmacological management of relapses • The potential of vitamin D for reducing frequency of relapse or progression • The non-pharmacological management of restricted mobility and spasticity. These have been covered by research recommendations in the NICE guideline. 3 4 5 National Institute for Health and Care Excellence. Management of multiple sclerosis in primary and secondary care. (Clinical Guideline 186.) 2014. www.nice.org.uk/Guidance/ CG186. McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin FD, et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol 2001;50:121-7. National Institute for Health and Care Excellence. Osteoporosis: assessing the risk of fragility fracture. (Clinical Guideline 146.) 2012. www.nice.org.uk/Guidance/CG146. For personal use only: See rights and reprints http://www.bmj.com/permissions 6 National Institute for Health and Care Excellence. Pressure ulcers: prevention and management of pressure ulcers. (Clinical Guideline 179.) 2014. www.nice.org.uk/Guidance/ CG179. Cite this as: BMJ 2014;349:g5701 © BMJ Publishing Group Ltd 2014 Subscribe: http://www.bmj.com/subscribe BMJ 2014;349:g5701 doi: 10.1136/bmj.g5701 (Published 8 October 2014) Page 6 of 6 PRACTICE Table Table 1| McDonald criteria for diagnosis of multiple sclerosis 4 Clinical attacks Lesions observed on MRI Additional criteria for diagnosis ≥2 ≥2 None required ≥2 1 Dissemination in space on MRI 1 2 Dissemination in time on MRI 1 1 Dissemination in both space and time 0 — One year of disease progression and at least 2 of: dissemination in space in brain; dissemination in space in spinal cord; positive result on CSF test MRI=magnetic resonance imaging; CSF=cerebrospinal fluid. For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
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