MULTIPLE SCLEROSIS. National clinical guideline for diagnosis and management in primary and secondary care
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1 The National Collaborating Centre for Chronic Condition Funded to produce guideline for the NHS by NICE MULTIPLE SCLEROSIS National clinical guideline for diagnoi and management in primary and econdary care With joint leaderhip from The Royal College of Phyician The Chartered Society of Phyiotherapy
2 Acknowledgement The NCC-CC and the development group would like to acknowledge the help and upport provided by Michael Pearon (joint executive lead at the Royal College of Phyician), Judy Mead (Joint Executive Lead, Chartered Society of Phyiotherapy), Aila Maye (Reviewer) and Rob Grant (Adminitrator NCC-CC). Alo, all thoe who commented on draft of thi guideline via the NICE takeholder conultation proce. ROYAL COLLEGE OF PHYSICIANS 11 St Andrew Place, London NW1 4LE Regitered charity No Copyright 2004 Royal College of Phyician of London ISBN Typeet by Dan-Set Graphic, Telford, Shrophire Printed in Great Britain by Sarum ColourView Group, Salibury, Wilthire
3 Memberhip of development group Conenu Reference Group (CRG) The name with an aterik (*) againt them were alo member of the Guideline Development Group (GDG). Jacqui Bradburn, repreenting the Royal College of Speech and Language Therapit Senior Speech and Language Therapit, North Britol NHS Trut, Frenchay Hopital, Britol Sarah Broughton, repreenting the College of Occupational Therapit* Senior Occupational Therapit, Royal Berkhire and Battle NHS Trut David Chadwick, CRG group leader/technical team Profeor of Neurology, Univerity of Liverpool Bernice Chiwell, repreenting the Britih Dietetic Aociation Senior Dietician, Bedford Hopital NHS Trut Angela Davie-Smith, repreenting the Chartered Society of Phyiotherapy* MS Firt Reearch Phyiotherapit, Britol General Hopital Louie Earll, Britih Pychological Society Head of Health Pychology, Glouceterhire Hopital NHS Trut Jane Hill, repreenting the Royal College of General Practitioner General Practitioner, Long Melford Practice, Long Melford, Suffolk Michael Johnon, repreenting the Aociation of Britih Neurologit* Conultant Neurologit, Leed Teaching Hopital NHS Trut Chritine Jone, repreenting the Multiple Scleroi Trut* Chief Executive, Multiple Scleroi Trut John Keen, repreenting the Royal College of General Practitioner* NHS GP, Bedford Park Surgery, Chiwick, London Glynn McDonald, repreenting the Multiple Scleroi Society* Policy and Campaign Manager, Multiple Scleroi Society Linday McLellan, repreenting the Society for Rehabilitation Reearch* Retired Conultant Phyician Bernie Porter, repreenting the Royal College of Nuring* Nure Conultant in Multiple Slceroi, National Hopital for Neurology and Neurourgery UCLH Trut David Pruce, GDG Group Leader* Director of Practice and Quality Improvement, Royal Pharmaceutical Society of Great Britain continued iii
4 Multiple cleroi: national clinical guideline for diagnoi and management Alan Thompon, repreenting the Intitute of Neurology Profeor of Clinical Neurology and Neurorehabilitation, National Hopital for Neurology and Neurourgery Nicki Ward, repreenting the Royal College of Nuring Lecturer Practitioner, Univerity of Central England Chri Ward, repreenting the Britih Society of Rehabilitation Medicine Head of Rehabilitation and Ageing at Southern Derbyhire Acute Hopital and Profeor of Rehabilitation Medicine and Neurology, Univerity of Nottingham Aim Wati, repreenting the Britih Society of Rehabilitation Medicine Conultant, Sheffield Teaching Hopital NHS Trut Chri Watt, repreenting the Faculty of Public Health Director of Public Health, Lewiham Primary Care Trut Technical team Jane Ingham Manager, NCC-CC Caroline Main, Sytematic Reviewer CRD, York Haina Shaikh, Information Scientit Information Scientit, NCC-CC Rob Riemma and Suan O Meara, Review Manager CRD, York Jennifer Robert, Health Economit Senior Lecturer, ScHARR, Univerity of Sheffield Derick Wade, Clinical Advior Profeor of Neurological Diability, Nuffield Orthopaedic Centre Penny Whiting, Sytematic Reviewer CRD, York The NHS Alliance and The Britih Aociation of Prothetit and Orthotit were invited, but were unable, to participate in the development. iv
5 Content Preface Executive ummary Gloary ix xi xv DEVELOPMENT OF THE GUIDELINE 1 Introduction Guideline aim Who i the guideline intended for? Clinical context The challenge Underlying guideline principle How to ue thi document The tructure of the document Guideline limitation Plan for guideline reviion 7 2 Methodology The developer The cope of the guideline Involvement of people with MS Searching for the evidence Syntheiing the evidence Health economic evidence Drafting the recommendation Agreeing the recommendation Writing the guideline 14 THE GUIDELINE 3 General principle of care Interaction between the profeional and peron with MS Communicating and giving information Giving emotional upport to people with MS Encouraging autonomy/elf-management Support to family and informal carer Team approache to rehabilitation Interaction between the team and the peron with MS: approache to rehabilitation Teamwork and goal etting Service organiation Specialit ervice Interface 32 v
6 Multiple cleroi: national clinical guideline for diagnoi and management Timing of action Involvement with ervice development Within-team communication Proviion of ervice over time (rehabilitation, maintenance, prevention and palliative care) 35 4 Dieae diagnoi and pecific treatment Making the diagnoi of MS Involving the peron with MS in the diagnotic proce Acute epiode: diagnoi General diagnoi Optic neuriti: diagnoi Tranvere myeliti: diagnoi Treatment of acute epiode General treatment Optic neuriti: treatment Acute epiode: rehabilitation Intervention affecting dieae progreion Other iue around altering the rik of relape Infection and immuniation Pregnancy Stre (variou type) 71 5 Rehabilitation and maintenance: functional activitie and ocial participation General introduction General rehabilitation Vocational activitie: employment and education Leiure and ocial interaction Mobility Activitie of daily living Equipment, adaptation and peronal upport 83 6 Diagnoi and treatment of pecific impairment Fatigue Bladder problem Bladder dyfunction Urinary tract dyfunction Bowel problem Weakne and cardiorepiratory fitne Spaticity, pam and contracture at joint Spaticity and pam Contracture at joint Ataxia and tremor Senory loe Viual problem Pain 111 vi
7 Content 6.10 Cognitive loe Emotionalim Depreion Anxiety Swallowing difficultie Speech difficultie Sexual dyfunction Preure ulcer Other treatment including complementary therapie Monitoring quality: audit and governance Reearch quetion Epidemiology of relape, impairment and activity limitation Diagnoing multiple cleroi Rehabilitation aement protocol Specialit neurological rehabilitation ervice Acute relape management: methylpredniolone and rehabilitation Dieae-modifying drug Relationhip between impairment and limitation in activitie 141 APPENDICES A: Expanded model of illne (WHO ICF plu) 145 B: Iue for people with MS and their carer 146 C: Literature earche 150 D: Searching for health economic evidence 153 E: Health economic of comparing different method of adminitration of 155 methylpredniolone in the treatment of acute relape in multiple cleroi F: Economic evidence for nuclear magnetic reonance imaging can in the 160 diagnoi of MS G: The McDonald Criteria 163 H: Aement and meaure 167 I: Evidence table 171 J: The cope of the clinical guideline 172 REFERENCES 175 vii
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9 Preface It i a pleaure to welcome you to thi guideline on the management of multiple cleroi (MS). It decribe bet practice for the health care management of a complex diorder that affect individual and their carer in many and varied way. Thi variability ha made it hard to plan a coheive or effective NHS ervice, and the challenge now i for all thoe involved in health care (thoe that commiion care, thoe that deliver care, and the patient and carer group) to enure that thee guideline are ued. We would particularly direct reader to the ix key meage et out in the Executive Summary at the front of the document and to the audit/implementation criteria (Section 7) for meauring the implementation proce. If thee are acted upon, then ervice proviion will be improved and thoe with MS will enjoy a better quality of life and le diability in the future. The guideline ha been developed by National Collaborating Centre for Chronic Condition (NCC-CC) with a commiion from the National Intitute for Clinical Excellence (NICE). The commiion tipulated that the guideline hould concentrate on the health (ie NHS) apect of multiple cleroi, and that while it would include the interface with other agencie including ocial ervice, it would not dicu their detailed proviion. An additional tipulation wa that topic already covered by an exiting NICE appraial report would be incorporated without further aement. For many area of MS there i little evidence upon which to bae recommendation, and the gap between the evidence have been filled with recommendation, baed on a formal conenu of the expert on our guideline group. In each ection of the document the level of upporting evidence i made clear on the undertanding that the tronger the evidence the greater likelihood that the recommendation baed on it are ound. However the reader hould not equate level of evidence with trength of recommendation ome of the mot important recommendation, with the greatet conequence for the health ervice or for people with MS, have been made by group conenu becaue there wa inadequate evidence. Thi i what the expert believe to be bet practice what they would recommend for their patient or relative. While the detail of local implementation of thi guideline may vary (according to local facilitie and geography), the main aim ought to be common acro England and Wale, and if adopted hould lead to better tandard of care and thu better outcome from thi often ditreing condition. There may be ome reader who will find particular recommendation, epecially thoe reached by conenu, hard to accept, and to them the challenge i to go out and produce and publih evidence to either confirm or refute what thi guideline et out. Thi additional reearch and thought applied to multiple cleroi could make future verion of thi guideline even tronger. Mike Pearon FRCP Director, National Collaborating Centre for Chronic Condition ix
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11 Executive ummary Multiple cleroi (MS) i diagnoed in 3.5 to 6.6 people per 100,000 of the population each year, equivalent to about 1,800 to 3,400 people each year in England and Wale. Prevalence i between 100 to 120 per 100,000 of the population, equivalent to about 52,000 to 62,000 people with MS in total in England and Wale. Some people with MS develop few ymptom, but for other the dieae and ociety interaction with them lead to problem affecting all apect of their live. The dieae often ha an impact upon the family. Many people with MS need to make extenive ue of primary and econdary health care, and ocial ervice. Thi guideline ugget how clinical ervice for people with MS can be improved both in term of delivery and in term of pecific intervention. The need of people with MS are imilar to thoe of many other patient with long-term condition, and thi guideline will have general leon which can be applied more widely than jut MS. The following recommendation have been identified a prioritie for implementation. Specialied ervice MS i a relatively rare condition often leading to complex problem that require expert ervice. We recommend that pecialit neurological and neurological rehabilitation ervice hould be available to every peron with MS when they need them, uually when they develop any new ymptom, ign, limitation on activitie or other problem, or when their circumtance change. We have made uggetion about what thi might mean for commiioner in the audit criteria ection of the guideline (Section 7). Rapid diagnoi Once a patient ha experienced ymptom uggetive of MS, a rapid diagnoi i needed. Thi enure that any required treatment are tarted, and reduce anxiety and uncertainty. We recommend that an individual who i upected of having MS hould be referred to a pecialit neurology ervice and een rapidly within an audited time. The individual hould be een again after all invetigation neceary to confirm or refute the diagnoi have been completed (alo rapidly within an audited time).* Seamle ervice People with MS often have complex problem requiring input from many different group both within and outide the NHS. Many find that bureaucracy and border dipute lead to tre and * The Guideline Development Group debated the meaning of the word rapidly. In thi context, it i taken to mean that the exact time will vary according to clinical need but hould, in the opinion of the development group, be no longer than ix week from referral to being een by a neurologit, and a further ix week until any neceary invetigation are completed. xi
12 Multiple cleroi: national clinical guideline for diagnoi and management delay in even the implet of action. Current policie hould leen thi, but till we recommend that every health commiioning organiation hould enure that all organiation in a local health area agree and publih protocol for haring and tranferring reponibility for and information about people with MS, o a to make the ervice eamle from the individual perpective. We recommend that thee protocol are publicly available and that the timecale involved are audited to enure that unneceary delay do not occur. A reponive ervice People with MS can experience one or more of a wide variety of ymptom and difficultie. Each peron need are unique, and a flexible repone i required from the NHS. We recommend that all ervice and ervice peronnel within the health care ector hould recognie and repond to the varying and unique need and expectation of each peron with MS. The peron with MS hould be involved actively in all deciion and action. In other word, ervice hould be patient centred. A patient-led ytem of audit can help addre ome of the difficultie in monitoring thi. Senitive but thorough problem aement The great variety of poible problem that people with MS may have can make it difficult for health care profeional to detect all relevant change. We have recommended that health ervice profeional in regular contact with people with MS, hould conider in a ytematic way whether the peron with MS ha a hidden problem contributing to their clinical ituation, uch a fatigue, depreion, cognitive impairment, impaired exual function or reduced bladder control. The main text of the guideline detail the variou problem that a peron with MS may have and appropriate way of treating thee problem. Self-referral after dicharge There i no predictable pattern or progre of the condition in any individual with MS, but problem may arie quickly at any time. Some people therefore have routine appointment to keep in touch, which i wateful and perpetuate a dependent approach, while many other fall out of the ytem until a crii occur. We have trongly recommended that every peron with MS who ha been een by a pecialit neurological or neurological rehabilitation ervice hould be informed about how to make contact with the ervice when he or he i no longer under regular treatment or review. The individual hould be given guidance on when uch contact i appropriate. Thi recommendation hould mean that each pecialit ervice (neurology, and neurological rehabilitation) ha in place a mechanim for accepting and reponding to direct contact by omeone with MS, even when they are no longer under regular treatment or review by that ervice. Concluion The full document give pecific advice to clinical taff on a huge range of iue uch a the management of bladder problem, the treatment of paticity, therapy for reduced walking ability and the identification and management of difficultie in wallowing. One trong meage xii
13 Executive ummary i that clinical taff need to be ytematic in their approach to each peron with MS o that all remediable problem are identified and managed effectively. Thi depend upon a well-trained body of taff working in a team with appropriate upport from information ytem. Finally, the document emphaie the importance of prevention of ill health, which i a vital function of the NHS. Prevention i epecially important in people with long-term condition becaue they are often at rik of many pecific econdary condition. For example people with MS may experience infection, contracture, and fall. However, the occurrence of a preure ulcer i perhap the mot eriou and the bet marker of ervice quality. We have uggeted that the occurrence of a preure ulcer in omeone with MS hould be conidered an advere event worthy of formal invetigation. If the NHS can deliver a good ervice to people with MS then it will alo be delivering a good ervice not imply to other people with neurological diability but to all people with long-term condition. Thi guideline hould help et the NHS on coure for thi. xiii
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15 Gloary Activitie of daily living (ADL) Thi phrae refer to activitie or tak undertaken a part of day-to-day life uch a getting dreed, cooking or hopping. They can be ubdivided into peronal ADL, dometic (houehold) ADL, and community ADL. Advere event Sometime known a ide effect. Advere event are any event that i not to the benefit of the peron. Some are predictable, and ome are only rare and unexpected. Advere event from drug might include, for example, rahe, feeling fatigued and being depreed. Advere event can alo follow rehabilitation treatment and might include falling while learning to walk and pain from tretching a joint. Allied health profeional Health care profeional, other than doctor and nure, directly involved in the proviion of health care. Include everal group uch a phyiotherapit, occupational therapit, dietician, etc. (Alo known a profeion allied to medicine or PAM.) Alternative therapie A term that i difficult to define becaue the claification of therapie i not fixed. Thi uually refer to treatment of any type which are not precribed or recommended by doctor, or are not given by health care profeional practicing within the NHS. Applicability The extent to which the reult of a tudy or review can be applied to the target population for a clinical guideline. Appraial of evidence Formal aement of the quality of reearch evidence and it relevance to the clinical quetion or guideline under conideration, according to predetermined criteria. Area under curve (AUC) See receiver operating curve (ROC). Aociation of Britih Neurologit (ABN) The profeional body to which all neurological pecialit phyician belong. ATG Anti-thymu globulin. Bia Sytematic error in the deign and execution of a tudy which may lead to an over- or underetimation of the true effect of a treatment or intervention. Blinding The practice of keeping the invetigator or ubject of a tudy ignorant of the group to which a ubject ha been aigned or of the population from which the ubject ha come. For example, a clinical trial in which the participating patient or their doctor are unaware of whether they are taking the experimental drug or a placebo (dummy treatment). The purpoe of blinding i to protect againt bia. Britih National Formulary (BNF) The BNF i the recognied authoritative ource of up-to-date information on drug and pharmaceutical product for health care profeional. The emphai i on thoe that are precribed in the UK, rather than over-thecounter medicine. It i a joint publication of the Britih Medical Aociation (BMA) and the Royal Pharmaceutical Society of Great Britain (RPSGB). CAM Complementary and alternative medicine, eg acupuncture, homeopathy. Cardiorepiratory fitne The extent to which the heart and lung are able to repond to demand. Fitne depend upon a) mucle, primarily in the leg and b) the heart and lung. Cae-control tudy A tudy that tart with the identification of a group of individual haring the ame characteritic (eg people with a particular dieae) and a uitable comparion (control) group (eg people without the dieae). All ubject are then aeed with repect to other factor, uch a thing that happened to them in the pat, eg thing that might be related to getting the dieae under invetigation. Ceiling effect See floor and ceiling effect. Cerebro-pinal fluid (CSF) Fluid produced in hollow tructure within the brain that circulate around the outide of the brain and alo down the pinal canal. CSF i removed when a lumbar puncture i undertaken. Clinical audit A ytematic proce for etting and monitoring tandard of clinical care. Patient note and other clinical record are examined a part of the xv
16 Multiple cleroi: national clinical guideline for diagnoi and management audit proce. Clinical audit hould cover the practice of all relevant health care profeional group, a oppoed to medical audit which only look at the doctor role in patient care. Wherea reearch define what the bet clinical practice hould be, audit invetigate whether bet practice i being carried out. Clinical effectivene How well a drug, treatment or package of care work to produce good outcome for patient. Clinical importance The importance of a particular guideline recommendation compared with other apect of clinical management that may be under conideration. Clinical trial Reearch tudy conducted with patient, uually to evaluate a new treatment or drug. Each trial i deigned to anwer cientific quetion and to find better way to treat individual with a pecific dieae. See alo randomied controlled trial. Clinician A health care profeional providing patient care, eg a doctor, nure or phyiotherapit. Cochrane Library The Cochrane Library conit of a regularly updated collection of evidence-baed medicine databae including the Cochrane Databae of Sytematic Review (review of randomied controlled trial prepared by the Cochrane Collaboration). The Cochrane Library i available on CD-ROM and on the Internet. Cognitive tatu Cognition refer to the procee involved in thinking, concentrating, planning, olving problem, learning, analying enation and remembering. A peron cognitive tatu i the extent to which they can ue their brain to undertake thee procee. Cohort tudy A cohort tudy take a group of patient and follow them forward in time and meaure their outcome (eg dieae or mortality rate). Patient ubgroup are then identified from information collected about patient and thee group are compared with repect to outcome, eg comparing mortality between one group that received a pecific treatment and one group which did not (or between two group that received different level of treatment). Cohort can be aembled in the preent and followed into the future (a concurrent cohort tudy ) or identified from pat record and followed forward from that time up to the preent (a hitorical cohort tudy ). Becaue patient are not randomly allocated to the two group, the group may be quite different in their characteritic and ome adjutment mut be made when analying the reult to enure that the comparion between group i a fair a poible. Competence In legal term, thi refer to the ability of omeone to make an informed judgement and it depend upon being able to undertand written or poken material ufficiently, hold the information in the memory and ue the material to make a conidered judgement. Complementary therapie See alternative therapie. Computeried tomography (CT) A technique whereby X-ray are ued to map the inide of the body, epecially the brain. Confidence interval Thi help u ae the likely effect of a clinical intervention by decribing a range of poible effect that are conitent with the reult of a tudy (or of a combination of tudie). A wide confidence interval indicate a lack of certainty or preciion about the true ize of the clinical effect and i een in tudie with too few patient. Where confidence interval are narrow they indicate more precie etimate of effect and a larger ample of patient tudied. We uually interpret a 95% confidence interval a the range of effect within which we are 95% confident that the true effect lie. Confounding factor Something that introduce uncertainty and bia into an oberved outcome, complicating interpretation. Conenu method A variety of technique that aim to reach an agreement on a particular iue. Formal conenu method include Delphi and nominal group technique, and conenu development conference. In the development of clinical guideline, conenu method may be ued where there i a lack of trong reearch evidence on a particular topic. Conitency The extent to which the concluion of a collection of tudie ued to upport a guideline recommendation are in agreement with each other. See alo homogeneity. Control group A group of patient recruited into a tudy that receive no treatment, a treatment of known effect, or a placebo (dummy treatment) in order to provide a comparion for a group xvi
17 Gloary receiving an experimental treatment, uch a a new drug. Controlled clinical trial (CCT) A tudy that include ome form of control that i not randomied. Correlation A meaure of the trength of aociation between two or more variable. For example in children height, weight and age are all correlated becaue older children tend to be taller and heavier. A poitive correlation indicate that one variable ha been oberved to increae a the other increae, a negative correlation indicate that one decreae a the other increae. Cot-benefit analyi A type of economic evaluation where both cot and benefit of health care treatment are meaured in the ame monetary unit. If benefit exceed cot, the evaluation would recommend providing the treatment. Cot-effectivene How expenive treatment and care are compared to how much benefit they offer to patient. In cot-effectivene analyi, the outcome of different intervention are converted into health gain for which a cot can be aociated, for example, cot per additional heart attack prevented. Croover tudy deign The adminitration of two or more experimental treatment one after the other in a pecified or random order to the ame group of patient. Deciion analytic model A method, in health economic, of etablihing the bet coure of action when evidence, both clinical and cot, i uncertain. Department of Health A generic term for four UK government department reponible for the health and wellbeing of people in England, Wale, Scotland and Northern Ireland, and having pecific reponibility for the National Health Service (NHS) and Social Service Inpectorate (SSI). DGH Ditrict general hopital (non-teaching hopital). Diagnotic odd ratio (DOR) DOR i ued a a ummary meaure of the accuracy of a diagnotic tet. It i calculated a the odd of a correct poitive reult, divided by the odd of a fale poitive reult. When a tet provide no diagnotic evidence then the DOR i 1.0, but a valuable diagnotic tet will tend to have a high DOR. Diagnotic tudy Any reearch tudy aimed at evaluating the utility of a diagnotic procedure. The method employed are generally different to thoe in a clinical trial aimed at evaluating an intervention. Diagnotic work-up The proce of making a diagnoi through tet, clinical hitory and clinical judgement. Dieae modifying therapie (DMT) Any treatment that low down, top or revere the procee that damage the nervou ytem in MS. Dieae progreion Thi pecifically refer to increaing damage to the nervou ytem. There i only a weak relationhip between damage to the nervou ytem and increaing ymptom or ign. And ome epiode of worening are imply due to another illne (eg bladder infection) and not progreion of the damage to the nervou ytem. Dominant An economic term for an intervention which i cheaper and clinically more effective than the alternative(). Dyarthria Difficulty of articulating word caued by dieae of the central nervou ytem, typically characteried by lurred peech, imprecie articulation and diorder of intonation. Economic evaluation Comparative analyi of alternative coure of action in term of both their cot and conequence. Effectivene The extent to which a pecific treatment or intervention, when ued under uual or everyday condition, doe what it i intended to do, eg control or cure an illne. (Clinical trial that ae effectivene are ometime called management trial.) Efficacy The ability of a drug or other treatment to control or cure an illne. In reearch term, efficacy refer to the extent to which a pecific intervention produce the intended (beneficial) reult under ideally controlled condition, eg in a laboratory. Epiode of care A technical, Department of Health term that refer to the whole of a treatment epiode from hopital admiion to dicharge or from tarting to topping a coure of treatment. xvii
18 Multiple cleroi: national clinical guideline for diagnoi and management Evidence-baed The proce of ytematically finding, appraiing, and uing reearch finding a the bai for clinical deciion. Evidence table A table ummariing the reult of a collection of tudie which, taken together, repreent the evidence upporting a particular recommendation or erie of recommendation in a guideline. Evoked potential Electrical change in the brain that follow timulation of the nervou ytem. The commonet example i to flah light in the eye, when an electrical change will occur over the occiput (back of the head) about 1/10th of a econd later. They can only be detected uing computer and many repeated timulation becaue the potential are o mall. Experimental tudy A reearch tudy deigned to tet if a treatment or intervention ha an effect on the coure or outcome of a condition or dieae. Extrapolation The application of reearch evidence baed on tudie of a pecific population to another population with imilar characteritic. Floor and ceiling effect Problem encountered in ome outcome meaure where there are limit to how low or high a numerical value they can aume, eg it i impoible to meaure more than 100%. Thee can make it difficult to ae the true effect of an intervention. Focu group Method of group interview or dicuion of between 6 and 12 people focued around a particular iue or topic. The method explicitly include and ue the group interaction to generate data. Functional tatu An individual ability to continue normal ocial and phyical activitie. Grade of recommendation A code (eg A, B, C) linked to a guideline recommendation, indicating the trength of the evidence upporting that recommendation. Guideline A ytematically developed tool which decribe apect of a patient condition and the care to be given. A good guideline make recommendation about treatment and care, baed on the bet reearch available, rather than opinion. It i ued to ait clinician and patient deciion making about appropriate health care for pecific clinical condition. Guideline recommendation Coure of action advied by the guideline development group on the bai of their aement of the upporting evidence. Health technology Health technologie include medicine, medical device uch a artificial hip joint, diagnotic technique, urgical procedure, health promotion (eg the role of diet v medicine in dieae management) and other therapeutic intervention. Health technology appraial (HTA) A health technology appraial, a undertaken by NICE, i the proce of determining the clinical and cot-effectivene of a health technology. NICE health technology appraial are deigned to provide patient, health profeional and manager with an authoritative ource of advice on new and exiting health technologie. Heterogeneity Or lack of homogeneity. The term i ued in meta-analye and ytematic review when the reult or etimate of effect from eparate tudie eem to have different magnitude or even different ign or direction. Difference in the patient population, outcome meaure, definition of variable and duration of follow-up of the tudie included in the analyi create problem of non-compatibility. See alo homogeneity. Hierarchy of evidence An etablihed hierarchy of tudy type, baed on the degree of certainty that can be attributed to the concluion of a well-conducted tudy. Well-conducted randomied controlled trial (RCT) are at the top of thi hierarchy. (Several large tatitically ignificant RCT which are in agreement repreent tronger evidence than, ay, one mall RCT.) Well-conducted tudie of patient view and experience would appear at a lower level in the hierarchy of evidence. See alo randomied controlled trial. Hitory, clinical The information collected and conidered by a health care profeional regarding an individual previou health-related experience. Homogeneity Thi mean that the reult of tudie included in a ytematic review are imilar and there i no evidence of heterogeneity. Reult are uually regarded a homogeneou when difference between tudie could reaonably be expected to occur by chance. See alo conitency, heterogeneity and ytematic review. HTA See health technology appraial. xviii
19 Gloary Iatrogenic Caued by a health care treatment. Incidence The rate of new occurrence of a condition or dieae, often given a people per year or epiode per year. Incluion criteria See election criteria. Intention to treat analyi An analyi of a clinical trial where patient are analyed according to the group to which they were initially randomly allocated, regardle of whether or not they had dropped out, fully complied with the treatment, or croed over and received the alternative treatment. Intervention Health care action intended to benefit the patient, eg precribing drug, urgical procedure, pychological therapy, etc. Intervention group In a clinical trial, group to which participant are allocated. Typically, thee group will receive different intervention or a placebo. Level of evidence A code (eg 1a, 1b) linked to an individual tudy, indicating where it fit into the hierarchy of evidence and how well it ha adhered to recognied reearch principle. See alo hierarchy of evidence. Literature review A proce of collecting, reading and aeing the quality of publihed (and unpublihed) article on a given topic. Local protocol See protocol. Low viion ervice Any local health ervice provided to cater for people experiencing viual problem. Magnetic reonance imaging (MRI) An imaging technique which ue powerful magnetic field rather than radiation to obtain accurate image of oft tiue inide the body. Some people cannot afely be canned with MRI, for example thoe with pacemaker. Meta-analyi Reult from a collection of independent tudie are pooled, uing tatitical technique to yntheie their finding into a ingle etimate of a treatment effect. A ytematic review may or may not include a meta-analyi. It i alway appropriate and deirable to ytematically review a erie of reult but it may ometime be inappropriate, or even mileading, to tatitically pool reult from eparate tudie. See alo ytematic review and heterogeneity. Methodological quality The extent to which a tudy ha conformed to recognied good practice in the deign and execution of it reearch method. Methodological weakne Any problem in the way in which a tudy ha been conducted, which throw doubt on the concluion. See methodological quality. Methodology The overall approach of a reearch project, eg the tudy will be a randomied controlled trial, of 200 people, over one year. See alo randomied controlled trial. Multimodal intervention An intervention compried of more than one apect which can affect outcome for the patient. Muculo-keletal pain Pain ariing from the mucular and keletal ytem, a ditinct from neurogenic pain. National Intitute for Clinical Excellence (NICE) NICE i a pecial health authority reponible for providing patient, health profeional and the public with authoritative, robut and reliable guidance on current bet practice. NICE commiioned and funded the development of thi guideline. Neurogenic Ariing from the nervou ytem. Neuropathic Pertaining to diorder of the nervou ytem. Non-experimental tudy A tudy baed on ubject elected on the bai of their availability, with no attempt having been made to avoid problem of bia. Objective meaure A meaurement that follow a tandardied procedure which i le open to ubjective interpretation by potentially biaed oberver and tudy participant. Odd ratio Odd are a way of repreenting probability, epecially familiar for betting. In recent year odd ratio have become widely ued in medical report. They provide an etimate (uually with confidence interval) for the effect of an intervention. Odd are ued to convey the idea of rik and an odd ratio of 1 between two treatment group would imply that the rik of an advere outcome were the ame in each group. For rare event the odd ratio and the relative rik (which ue actual rik xix
20 Multiple cleroi: national clinical guideline for diagnoi and management and not odd) will be very imilar. See alo control group, relative rik. Oligoclonal banding A phenomenon which can be detected by teting cerebro-pinal fluid. It can help to diagnoe MS. Optic neuriti Inflammation of the optic nerve, which carrie viual information from the eye to the brain. Orthodox therapie See alo alternative therapie. Any medical or phyical therapy which i uually ued or recommended by health care profeional working within the NHS Outcome The end reult of care and treatment and/or rehabilitation. In other word, the change in health, functional ability, ymptom or ituation of a peron, which can be ued to meaure the effectivene of care/treatment/rehabilitation. Reearcher decide what outcome to meaure before a tudy begin. Outcome are then aeed at the end of the tudy. Palliative care Care aimed at alleviating ymptom, pain and ditre, and hence improving quality of life, rather than at curing or lowing progreion of a dieae or condition. It i often aociated with, but i actually not limited to, the end of life. PCT See primary care trut. Pilot tudy A mall cale tet of the reearch intrument. For example, teting (piloting) a new quetionnaire with people who are imilar to the population of the tudy, in order to highlight any problem or area of concern, which can then be addreed before the full-cale tudy begin. Placebo A pill, medicine, or other treatment that ha no phyiological effect and i ued a a dummy treatment. A placebo may be ued a a comparion (control) in tet on new drug etc. Placebo effect A beneficial (or advere) effect produced by a placebo and not due to any property of the placebo itelf. See placebo. Pooled etimate An etimate of the effect of a treatment, arrived at through a meta-analyi. Potpartum After childbirth. Pre-pot tudy A tudy deign which meaure outcome in one group of people, firt before, and then after, an intervention i given or initiated. Prevalence The proportion of a population of people who are experiencing a condition or dieae at a given time. Primary care Health care delivered to patient outide hopital. Primary care cover a range of ervice provided by GP, nure and other health care profeional, dentit, pharmacit and optician. Primary care trut A primary care trut i an NHS organiation reponible for improving the health of local people, developing ervice provided by local GP and their team (called primary care) and making ure that other appropriate health ervice are in place to meet local people need. Prior probability In a diagnotic tudy, the proportion of the population which ha the condition in quetion, regardle of what the tet reult ubequently i. Probability How likely an event i to occur, eg how likely a treatment or intervention will alleviate a ymptom. Prognotic factor Patient or dieae characteritic which influence the coure of a particular condition. In a randomied trial to compare two treatment, chance imbalance in variable (prognotic factor) that influence patient outcome are poible, epecially if the ize of the tudy i fairly mall. In term of analyi thee prognotic factor become confounding factor. See confounding factor. Propective tudy A tudy in which people are entered into the reearch and then followed up over a period of time with future event recorded a they happen. Propective tudie may be of everal type, including cohort or randomied controlled trial. See cohort tudy and randomied controlled trial. Protocol A policy or trategy which define appropriate action. A reearch protocol et out, in advance of carrying out the tudy, what quetion i to be anwered and how information will be collected and analyed. Guideline implementation protocol et out how guideline recommendation will be ued in practice by the NHS, at both national and local level. xx
21 Gloary P-value If a tudy i done to compare two treatment then the P-value i the probability of obtaining the reult, or omething more extreme, if there really wa no difference between treatment. Suppoe P = What thi mean i that if there really wa no difference between treatment then there would only be a 3% chance of getting the kind of reult obtained. Since thi chance eem quite low we hould quetion the validity of the aumption that there really i no difference between treatment. We would conclude that there probably i a difference between treatment. By convention, where the value of P i below 0.05 (ie le than 5% ) the reult i een a tatitically ignificant. Where the value of P i or le, the reult i een a highly ignificant. P value jut tell u whether an effect can be regarded a tatitically ignificant or not. In no way do they relate to how big the effect might be, for which we need the confidence interval. Qualitative method Reearch technique ued to decribe life experience and give them meaning, uing a ytematic, ubjective approach. Thi type of reearch i conducted in order to decribe and promote undertanding of people experience, feeling, motivation and behaviour. Example of qualitative method include focu group, indepth interview and participant obervation. Thee technique generate non-numerical data, eg a patient decription of their pain rather than a meaure of pain. Quality-adjuted life year (QALY) A meaure of health outcome. QALY are calculated by etimating the total life-year gained from a treatment and weighting each year with a quality of life core. Quantitative method Reearch technique that generate numerical data or data that can be converted into number. For example, cenu quetion uch a the number of people living in a houehold. Quai-experimental tudy Thi i a tudy in which the treatment comparion group are not aigned by randomiation. Randomied controlled trial A trial in which people are randomly aigned to two (or more) group: one (the experimental group) receiving the treatment that i being teted, and the other (the comparion or control group) receiving an alternative treatment, a placebo (dummy treatment) or no treatment. The two group are followed up to compare difference in outcome to ee how effective the experimental treatment wa. Receiver operating curve (ROC) A mathematical method of comparing diagnotic procedure involving their pecificity and enitivity. The cloer the area under the curve (AUC) i to 1, the better the tet. Reference tandard In diagnotic tudie, the tet being evaluated i often compared to the bet known diagnotic procedure, which i known a the reference tandard or gold tandard. Rehabilitation Rehabilitation i a proce that focue on ability and aim to optimie ocial participation and to minimie ditre and tre for both the peron with MS and any carer involved, mainly through a problem-olving approach that will involve multi-focal intervention from a pecialit team over time. Relative rik A ummary meaure which repreent the ratio of the rik of a given event in group of ubject compared to another group. When the rik of the event of interet i the ame in the two group the relative rik i 1. Relative rik i ometime ued a a ynonym for rik ratio. In a treatment comparion tudy a relative rik of 2 would indicate that patient receiving one of the treatment had twice the rik of an undeirable outcome than thoe receiving the other treatment. Relative rik-benefit ratio A method of comparing two intervention, balancing the rik and benefit of each to a defined population. Reliability Reliability refer to a method of meaurement that conitently give the ame reult. For example, omeone who ha a high core on one occaion tend to have a high core if meaured on another occaion very oon afterward. With phyical aement it i poible for different clinician to make independent aement in quick ucceion and if their aement tend to agree then the method of aement i aid to be reliable. Review Summary of the main point and trend in the reearch literature on a pecified topic. A review i conidered non-ytematic unle an extenive literature earch ha been carried out to enure that all apect of the topic are covered and an objective appraial made of the quality of the tudie. xxi
22 Multiple cleroi: national clinical guideline for diagnoi and management Sample A part of the tudy target population from which the ubject of the tudy will be recruited. If ubject are drawn in an unbiaed way from a particular population, the reult can be generalied from the ample to the population a a whole. Sampling Refer to the way participant are elected for incluion in a tudy. Secondary Condition and ymptom which are brought about by an exiting dieae or condition are decribed a econdary. For example, econdary pain can reult from retriction in mobility becaue of MS. The pain in thi cae i econdary to the MS. Secondary care Care provided in hopital. Selection criteria Explicit criteria ued by guideline development group to decide which tudie hould be included and excluded from conideration a potential ource of evidence. Self-report meaure An outcome meaure which ue the view and experience of the peron with MS rather than clinical meaurement. Senitivity The enitivity of a diagnotic tet i the proportion of people with MS who, when teted, have a true poitive reult. Senitivity analyi A mathematical proce, often employed in good quality health economic tudie, which aee the enitivity of the concluion to inaccuracy in the etimate regarding cot, clinical effectivene of the treatment, and the tructure of the health ervice. Sequelae A condition occurring a a conequence of a dieae. Significance, tatitical Alo ignificant difference or ignificant effect. Specialit Health care profeional with relevant qualification, neceary knowledge and kill. Specificity The pecificity of a diagnotic tet i the proportion of people without MS who, when teted, have a true negative reult. Stakeholder Any national organiation, including patient and carer group, health care profeional and commercial companie with an interet in the guideline under development. Standard deviation A meaure of the pread, catter or variability of a et of meaurement. Uually ued with the mean to decribe numerical data. Survey A tudy in which information i ytematically collected from people (uually from a random ample within a defined population). Sytematic Methodical, according to plan; not random. Sytematic review A review in which evidence from cientific tudie ha been identified, appraied, and yntheied in a methodical way according to predetermined criteria. May or may not include a meta-analyi. Sytemic Involving the whole body. Tertiary centre A major medical centre providing complex treatment, which receive referral from both primary and econdary care. Sometime called a tertiary referral centre. See alo primary care and econdary care. Tranvere myeliti Inflammation with neurological ymptom, caued by leion on the pinal cord. Trial of treatment A planned period during which a peron with MS receive a treatment to find out if it will be of benefit to them a individual. Trut A trut i an NHS organiation reponible for providing a group of health care ervice. An acute trut provide hopital ervice. A mental health trut provide mot mental health ervice. A primary care trut buy hopital care on behalf of the local population, a well a being reponible for the proviion of community health ervice. Validity Aement of how well a tool or intrument meaure what it i intended to meaure. See alo external validity, internal validity. Well-being A concept combining an individual health, their quality of life, and their atifaction. There i no univerally agreed definition that i ueful in the context of health care. xxii
23 DEVELOPMENT OF THE GUIDELINE
24 1 Introduction 1.1 Guideline aim Multiple cleroi (MS) i a condition of the central nervou ytem (brain and pinal cord) that uually tart in early adult life. Once preent the dieae never goe; there i no cure and the peron live with the condition for life but a ignificant proportion of people have few or no problem. The impact of MS on the individual i variable but one contant feature i uncertainty. The condition alo ha an impact on family member Many people with MS may need to make extenive ue of health ervice and ocial ervice. Conequently, the aim of thi guideline i to enure that people with MS benefit from a coherent and conitent repone from ervice, to minimie their problem a far a can be achieved. 1.2 Who i the guideline intended for? A guideline ha been defined a a ytematically developed tatement that ait clinician and patient in making deciion about appropriate treatment for a pecific condition. 1 Thee guideline are aimed at helping health care profeional provide optimal ervice for thoe with MS by: providing individual clinician with a et of explicit tatement on the bet way to manage mot common clinical problem to maximie the effectivene of the ervice providing commiioning organiation and provider ervice with pecific guidance on the bet way to organie complex ervice, to maximie efficiency and equity. Other, including the general public, may find the guideline of ue in undertanding the clinical approach to MS. Separate hort-form document for a) the public and b) clinical taff are available which ummarie the recommendation without full detail of the upporting evidence. 1.3 Clinical context MS i diagnoed in 3.5 to 6.6 people per 100,000 of the population each year, equivalent to about 1,820 to 3,380 new people being diagnoed each year in England and Wale (population 52 million). Life expectancy in the majority i more or le normal. The prevalence (frequency in the population) i between 100 to 120 per 100,000, equivalent to two people for each general practitioner or 52,000 to 62,400 people in total in England and Wale. 2 4 In comparion, the incidence of troke i 240 per 100,000 each year, equivalent to about 124,800 new cae each year in England and Wale. The prevalence i about 700 per 100,000, equivalent to about 14 per GP or 364,000 people in England and Wale in total. Multiple cleroi i uually diagnoed between the age of 20 and 50 year. Once diagnoed, people often recognie that they have had the condition for many year. It affect two women for each man affected. The caue i unknown, but it i thought to have everal different caue becaue the evidence ugget that there are both genetic (inherited) and environmental factor at play. 3
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