ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis
Background and purpose Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is therefore a need for a reference tool compiling current data to aid professionals in treatment decisions. The objective was to develop an evidence‐based clinical practice...
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| Veröffentlicht in: | European journal of neurology Jg. 25; H. 2; S. 215 - 237 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
England
John Wiley & Sons, Inc
01.02.2018
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| Schlagworte: | |
| ISSN: | 1351-5101, 1468-1331, 1468-1331 |
| Online-Zugang: | Volltext |
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| Abstract | Background and purpose
Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is therefore a need for a reference tool compiling current data to aid professionals in treatment decisions. The objective was to develop an evidence‐based clinical practice guideline for the pharmacological treatment of people with MS.
Methods
This guideline has been developed using the GRADE methodology and following the updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. Literature searches up to December 2016 were performed and the evidence is presented narratively and, when possible, combined in a meta‐analysis. The quality of evidence was rated into four categories – very high, high, low and very low − according to the risk of bias. The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk−benefit balance. Consensus between the panelists was reached by use of the modified nominal group technique.
Results
A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease‐modifying drugs approved by the European Medicine Agency at the time of publication. A total of 21 recommendations were agreed by the guideline working group members after three rounds of consensus.
Conclusion
The present guideline, which includes descriptions of the evidence together with recommendations, will enable homogeneity of treatment decisions across Europe. |
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| AbstractList | Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process.BACKGROUND AND PURPOSEMultiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process.This guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique.METHODSThis guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique.A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus.RESULTSA total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus. Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process. This guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique. A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus. Background and purpose Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process. Methods This guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique. Results A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus. Click here for the corresponding questions to this CME article. Background and purpose Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is therefore a need for a reference tool compiling current data to aid professionals in treatment decisions. The objective was to develop an evidence‐based clinical practice guideline for the pharmacological treatment of people with MS. Methods This guideline has been developed using the GRADE methodology and following the updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. Literature searches up to December 2016 were performed and the evidence is presented narratively and, when possible, combined in a meta‐analysis. The quality of evidence was rated into four categories – very high, high, low and very low − according to the risk of bias. The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk−benefit balance. Consensus between the panelists was reached by use of the modified nominal group technique. Results A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease‐modifying drugs approved by the European Medicine Agency at the time of publication. A total of 21 recommendations were agreed by the guideline working group members after three rounds of consensus. Conclusion The present guideline, which includes descriptions of the evidence together with recommendations, will enable homogeneity of treatment decisions across Europe. |
| Author | Otero‐Romero, S. Chandraratna, D. Pilling, S. Fazekas, F. Hemmer, B. Havrdova, E. Wiendl, H. Sormani, M. P. Thompson, A. J. Liblau, R. Siva, A. Selmaj, K. Hartung, H. P. Lubetzki, C. Miller, D. H. Zipp, F. Olsson, T. Marcus, E. Sorensen, P. S. Derfuss, T. Thalheim, C. Amato, M. P. Montalban, X. Kappos, L. Gold, R. Clanet, M. Comi, G. |
| Author_xml | – sequence: 1 givenname: X. surname: Montalban fullname: Montalban, X. email: xavier.montalban@cem-cat.org organization: Vall d'Hebron University Hospital – sequence: 2 givenname: R. surname: Gold fullname: Gold, R. email: ralf.gold@rub.de organization: Ruhr University, St Josef‐Hospital – sequence: 3 givenname: A. J. surname: Thompson fullname: Thompson, A. J. organization: University College London Institute of Neurology – sequence: 4 givenname: S. orcidid: 0000-0002-1451-6927 surname: Otero‐Romero fullname: Otero‐Romero, S. organization: Vall d'Hebron University Hospital – sequence: 5 givenname: M. P. surname: Amato fullname: Amato, M. P. organization: University of Florence – sequence: 6 givenname: D. surname: Chandraratna fullname: Chandraratna, D. organization: Multiple Sclerosis International Federation – sequence: 7 givenname: M. surname: Clanet fullname: Clanet, M. organization: Toulouse University Hospital – sequence: 8 givenname: G. surname: Comi fullname: Comi, G. organization: University Vita‐Salute San Raffaele – sequence: 9 givenname: T. surname: Derfuss fullname: Derfuss, T. organization: University Hospital Basel – sequence: 10 givenname: F. surname: Fazekas fullname: Fazekas, F. organization: Medical University of Graz – sequence: 11 givenname: H. P. surname: Hartung fullname: Hartung, H. P. organization: Heinrich‐Heine‐University – sequence: 12 givenname: E. surname: Havrdova fullname: Havrdova, E. organization: Charles University – sequence: 13 givenname: B. surname: Hemmer fullname: Hemmer, B. organization: Munich Cluster for Systems Neurology (SyNergy) – sequence: 14 givenname: L. surname: Kappos fullname: Kappos, L. organization: University Hospital Basel – sequence: 15 givenname: R. surname: Liblau fullname: Liblau, R. organization: Université de Toulouse, UPS – sequence: 16 givenname: C. surname: Lubetzki fullname: Lubetzki, C. organization: Sorbonne Universités UPMC Univ Paris 06, UMR_S 1127 – sequence: 17 givenname: E. surname: Marcus fullname: Marcus, E. organization: University College London – sequence: 18 givenname: D. H. surname: Miller fullname: Miller, D. H. organization: University College London (UCL) Institute of Neurology – sequence: 19 givenname: T. surname: Olsson fullname: Olsson, T. organization: Karolinska University Hospital (Solna) – sequence: 20 givenname: S. surname: Pilling fullname: Pilling, S. organization: University College London – sequence: 21 givenname: K. surname: Selmaj fullname: Selmaj, K. organization: Medical University of Lodz – sequence: 22 givenname: A. surname: Siva fullname: Siva, A. organization: Istanbul University – sequence: 23 givenname: P. S. surname: Sorensen fullname: Sorensen, P. S. organization: Copenhagen University Hospital Rigshospitalet – sequence: 24 givenname: M. P. surname: Sormani fullname: Sormani, M. P. organization: University of Genoa – sequence: 25 givenname: C. surname: Thalheim fullname: Thalheim, C. organization: European Multiple Sclerosis Platform (EMSP) – sequence: 26 givenname: H. surname: Wiendl fullname: Wiendl, H. organization: University of Münster – sequence: 27 givenname: F. surname: Zipp fullname: Zipp, F. organization: University Medical Centre of the Johannes Gutenberg University Mainz |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29352526$$D View this record in MEDLINE/PubMed http://kipublications.ki.se/Default.aspx?queryparsed=id:137462451$$DView record from Swedish Publication Index (Karolinska Institutet) |
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| Notes | Multiple Sclerosis Journal European Journal of Neurology and [Correction added on 13 February 2018, after online and print publication: (a) The abstract has been updated and a conclusion section in now included; (b) Recommendation 4 and 7 has been amended, and an additional recommendation has been added after the latter]. https://www.ean.org/CME.2714.0.html Certificates for correctly answered questions will be issued by EAN directly, you simply have to be logged‐in. With positive results, EAN recommends accreditation of 1 hour of CME, which may be claimed with the national body in charge of CME accreditation. This paper is being simultaneously published in This is a Continuing Medical Education article, and can be found with corresponding questions on the EAN website, LEARN section . ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
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Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is therefore a need for a... Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must... Background and purpose Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis... |
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| SubjectTerms | Central nervous system Clinical medicine Decision making demyelinating diseases disease‐modifying treatment Drug therapy Drugs Europe Experimental allergic neuritis GRADE methodology guideline Health care Humans Medical personnel Multiple sclerosis Multiple Sclerosis - drug therapy neurological disorders Neurology Neurology - standards Pharmacology Practice Guidelines as Topic - standards Pregnancy Quality research methods Safety Societies, Medical - standards |
| Title | ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis |
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