PMID- 34900327
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220429
IS  - 2055-2173 (Print)
IS  - 2055-2173 (Electronic)
IS  - 2055-2173 (Linking)
VI  - 7
IP  - 4
DP  - 2021 Oct
TI  - Multiple Sclerosis International Federation guideline methodology for off-label 
      treatments for multiple sclerosis.
PG  - 20552173211051855
LID - 10.1177/20552173211051855 [doi]
LID - 20552173211051855
AB  - BACKGROUND: A total of 2.8 million people are living with multiple sclerosis and 
      due to disparities in access to medicines, the ability to treat this condition 
      varies widely. Off-label disease-modifying therapies are sometimes more available 
      or affordable in different health systems. Appropriate methodology is integral in 
      creating high-quality and trustworthy guidelines. In this article, we outline 
      Multiple Sclerosis International Federation's (MSIF) approach to creating 
      guidelines for off-label treatments for multiple sclerosis. METHODS: We use the 
      Guidelines International Network (GIN)-McMaster Guideline Development Checklist 
      and the Grading of Recommendations, Assessment, Development and Evaluations 
      (GRADE) Evidence-to-Decision (EtD) framework. We developed detailed health 
      descriptors for health outcomes and the panel drafted PICO (Population, 
      Intervention, Comparator, Outcome) questions and prioritised outcomes. We 
      collaborate with independent organisations, which systematically review and 
      collate the information. We are actively engaging stakeholders and consulting 
      with relevant organisations, boards, working groups and individuals. RESULTS: The 
      draft guideline recommendations will be published for open comment and 
      stakeholders will be encouraged to endorse and disseminate the guidelines. Our 
      methodology ensures integrity and transparency in the criteria, evidence and 
      judgement used to make recommendations. CONCLUSIONS: This approach will 
      facilitate transparent creation of high-quality and trustworthy guidelines, and 
      allow the global guidelines to be adopted or adapted into national settings.
CI  - (c) The Author(s), 2021.
FAU - Piggott, Thomas
AU  - Piggott T
AUID- ORCID: 0000-0003-1643-5386
AD  - Department of Health Research Methods, Evidence, and Impact, McMaster University, 
      Hamilton, ON, Canada. RINGGOLD: 152642
FAU - Nonino, Francesco
AU  - Nonino F
AD  - Cochrane Multiple Sclerosis and Rare Diseases of the CNS Review Group, IRCCS 
      Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy. RINGGOLD: 419170
FAU - Baldin, Elisa
AU  - Baldin E
AD  - Cochrane Multiple Sclerosis and Rare Diseases of the CNS Review Group, IRCCS 
      Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy. RINGGOLD: 419170
FAU - Filippini, Graziella
AU  - Filippini G
AD  - Cochrane Multiple Sclerosis and Rare Diseases of the CNS Review Group, Scientific 
      Director's Office, Carlo Besta Foundation and Neurological Institute, Milan, 
      Italy.
FAU - Rijke, Nick
AU  - Rijke N
AD  - Multiple Sclerosis International Federation, London, UK. RINGGOLD: 502845
FAU - Schunemann, Holger
AU  - Schunemann H
AD  - Department of Health Research Methods, Evidence, and Impact, McMaster University, 
      Hamilton, ON, Canada. RINGGOLD: 502845
FAU - Laurson-Doube, Joanna
AU  - Laurson-Doube J
AUID- ORCID: 0000-0001-9619-9170
AD  - Multiple Sclerosis International Federation, London, UK. RINGGOLD: 502845
LA  - eng
PT  - Journal Article
DEP - 20211207
PL  - United States
TA  - Mult Scler J Exp Transl Clin
JT  - Multiple sclerosis journal - experimental, translational and clinical
JID - 101668877
PMC - PMC8655455
OTO - NOTNLM
OT  - Grading of Recommendations, Assessment, Development and Evaluations (GRADE)
OT  - Multiple sclerosis
OT  - disease-modifying therapies
OT  - guideline methodology
OT  - off-label treatment
OT  - recommendations
COIS- Declaration of conflicting interests: Multiple Sclerosis International Federation 
      (MSIF) is an alliance of national multiple sclerosis (MS) organizations. MSIF 
      receives income from a wide range of sources, including healthcare and other 
      companies, individuals, member organizations, campaigns, foundations, and trusts. 
      Over the last five years, MSIF received funding from the following companies: 
      Biogen, Bristol Myers Squibb (formerly Celgene), MedDay, Merck, Mylan, Novartis, 
      Roche, Sanofi Genzyme, and Teva. Our independence and all our donations from the 
      healthcare industry are governed by our policy: 
      http://www.msif.org/wp-content/uploads/2017/09/Policyand-Practices-in-Relationships-with-the-Healthcare-Industry-2017.pdf. 
      Thomas Piggott, Nick Rijke, Francesco Nonino, Elisa Baldin, Graziella Filippini 
      and Joanna Laurson-Doube have no relevant individual conflicts of interest. 
      Holger Schunemann is co-chair of the GRADE Working Group.
EDAT- 2021/12/14 06:00
MHDA- 2021/12/14 06:01
PMCR- 2021/12/07
CRDT- 2021/12/13 18:02
PHST- 2021/05/24 00:00 [received]
PHST- 2021/09/21 00:00 [revised]
PHST- 2021/09/21 00:00 [accepted]
PHST- 2021/12/13 18:02 [entrez]
PHST- 2021/12/14 06:00 [pubmed]
PHST- 2021/12/14 06:01 [medline]
PHST- 2021/12/07 00:00 [pmc-release]
AID - 10.1177_20552173211051855 [pii]
AID - 10.1177/20552173211051855 [doi]
PST - epublish
SO  - Mult Scler J Exp Transl Clin. 2021 Dec 7;7(4):20552173211051855. doi: 
      10.1177/20552173211051855. eCollection 2021 Oct.