International consensus on quality standards for brain health-focused care in multiple sclerosis

Jeremy Hobart, Amy Bowen, George Pepper, Harriet Crofts, Lucy Eberhard, Thomas Berger, Alexey Boyko, Cavit Boz, Helmut Butzkueven, Elisabeth Gulowsen Celius, Jelena Drulovic, José Flores, Dana Horáková, Christine Lebrun-Frénay, Ruth Ann Marrie, James Overell, Fredrik Piehl, Peter Vestergaard Rasmussen, Maria José Sá, Carmen-Adella Sîrbu, Eli Skromne, Øivind Torkildsen, Vincent van Pesch, Timothy Vollmer, Magd Zakaria, Tjalf Ziemssen, Gavin Giovannoni, Jeremy Hobart, Amy Bowen, George Pepper, Harriet Crofts, Lucy Eberhard, Thomas Berger, Alexey Boyko, Cavit Boz, Helmut Butzkueven, Elisabeth Gulowsen Celius, Jelena Drulovic, José Flores, Dana Horáková, Christine Lebrun-Frénay, Ruth Ann Marrie, James Overell, Fredrik Piehl, Peter Vestergaard Rasmussen, Maria José Sá, Carmen-Adella Sîrbu, Eli Skromne, Øivind Torkildsen, Vincent van Pesch, Timothy Vollmer, Magd Zakaria, Tjalf Ziemssen, Gavin Giovannoni

Abstract

Background: Time matters in multiple sclerosis (MS). Irreversible neural damage and cell loss occur from disease onset. The MS community has endorsed a management strategy of prompt diagnosis, timely intervention and regular proactive monitoring of treatment effectiveness and disease activity to improve outcomes in people with MS.

Objectives: We sought to develop internationally applicable quality standards for timely, brain health-focused MS care.

Methods: A panel of MS specialist neurologists participated in an iterative, online, modified Delphi process to define 'core', 'achievable' and 'aspirational' time frames reflecting minimum, good and high care standards, respectively. A multidisciplinary Reviewing Group (MS nurses, people with MS, allied healthcare professionals) provided insights ensuring recommendations reflected perspectives from multiple stakeholders.

Results: Twenty-one MS neurologists from 19 countries reached consensus on most core (25/27), achievable (25/27) and aspirational (22/27) time frames at the end of five rounds. Agreed standards cover six aspects of the care pathway: symptom onset, referral and diagnosis, treatment decisions, lifestyle, disease monitoring and managing new symptoms.

Conclusion: These quality standards for core, achievable and aspirational care provide MS teams with a three-level framework for service evaluation, benchmarking and improvement. They have the potential to produce a profound change in the care of people with MS.

Keywords: Delphi technique; Multiple sclerosis; benchmarking; consensus; quality improvement; standards.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J.H. has received consulting fees, honoraria, support to attend meetings or research support from Acorda, Asubio, Bayer Schering, Biogen Idec, F. Hoffmann-La Roche, Genzyme, Merck Serono, Novartis, Oxford Health Policy Forum, Oxford PharmaGenesis and Teva. G.P. has received consulting fees from Biogen, Novartis, Oxford Health Policy Forum, Oxford PharmaGenesis and Teva. H.C. and L.E. are employees of Oxford PharmaGenesis Ltd., and work on this study was carried out as part of their role at the company. A.Boyko. has received honoraria as a member of working groups and advisory boards and participated in clinical trials for Biogen, Schering, Merck, Teva, Novartis, Sanofi Genzyme, Actelion, Biocad and Generium. H.B. has received personal fees from Biogen, Merck, Novartis, Oxford Health Policy Forum, Oxford PharmaGenesis and Teva, and research support from Biogen and Novartis. E.G.C. has received personal fees from Almirall, Biogen, Merck, Roche and Teva, and grants and personal fees from Novartis and Sanofi. J.D. has received fees for serving on scientific advisory boards for Bayer Schering Pharma, Merck Serono, Teva, Genzyme, a Sanofi Company, Roche; has received speaker honoraria from Merck Serono, Teva, Bayer Schering, Genzyme, a Sanofi Company, Medis and Roche; and has received research grant support from the Ministry of Education and Science, Republic of Serbia (project no. 175031). D.H. has received grants from Czech Ministry of Education project Progres Q27/LF1, and speaker honoraria, travel expenses and consultancy fees from Biogen, Novartis, Merck, Roche, Sanofi Genzyme and Teva. J.O. has received grants, personal fees and non-financial support from Biogen, Novartis, Roche and Genzyme, and personal fees and non-financial support from Allergan, Merck and Teva. F.P. has received research grants from Biogen, Novartis and Genzyme, and fees for serving as Chair of DMC in clinical trials with Parexel. P.V.R. has received grant support from Novartis; has received fees for acting as a consultant or advisory board member for Allergan, Biogen, Merck, Novartis, Roche, Sanofi-Aventis and Teva; and has received speaker fees from Teva. M.J.S. has received speaker and/or consulting fees from Bayer, Biogen, CSL Behring, Merck, Novartis, Roche, Sanofi Genzyme and Teva. C.-A.S. has received conference expenses from Bayer, Medison Pharma, Merck, Novartis and Teva. Ø.T. has received speaker honoraria and fees for serving on scientific advisory boards from Biogen, Merck and Sanofi-Aventis, and has received speaker honoraria from Novartis. V.v.P. has received travel grants from Biogen, Genzyme, Merck, Teva, Roche and Novartis Pharma. His institution receives honoraria for consultancy and lectures from Biogen, Genzyme, Merck, Roche, Teva and Novartis Pharma as well as research grants from Sanofi, Novartis Pharma and Roche. T.V. has received compensation for acting as a consultant, speaker or advisory board member for Academic CME, Alcimed, Anthem Blue Cross, Genentech/Roche, Biogen IDEC, Novartis, CellGene, Epigene, Rocky Mountain MS Center, GLG Consulting, Ohio Health, Oxford Health Policy Forum, Oxford PharmaGenesis, TG Therapeutics, Topaz Therapeutics, Dleara Lawyers and Teva Neuroscience, and has received research support from Teva Neuroscience, NIH/NINDS, Rocky Mountain MS Center, Actelion, Biogen, Novartis, Roche/Genentech and TG Therapeutics, Inc. T.Z. has received grants and personal fees from Biogen, Novartis, Sanofi and Teva, and personal fees from Almirall, Bayer, Merck, Oxford Health Policy Forum and Roche. G.G. has received consulting fees from AbbVie, Atara Biotherapeutics, Almirall, Biogen, Celgene, GlaxoSmithKline, MedDay Pharmaceuticals, Merck and Company (USA), Merck Group (Europe), Novartis, Oxford Health Policy Forum, Oxford PharmaGenesis, Roche, Sanofi Genzyme, Synthon, Takeda, Teva Pharmaceutical Industries Ltd. and UCB, and has received research support from Biogen, Sanofi Genzyme and Takeda. A.Bowen., C.B., T.B., J.F., C.L.-F., R.A.M., E.S. and M.Z. declare no competing interests.

Figures

Figure 1.
Figure 1.
Study flow for the MS Brain Health Delphi process. MS: multiple sclerosis.
Figure 2.
Figure 2.
Consensus standards for timely, brain health-focused MS care agreed by at least 75% of the Delphi Consensus Panel related to (a) referral and diagnosis, (b) priorities following diagnosis, (c) routine monitoring and support, (d) treatment decisions, (e) new symptoms and (f) additional statements that were not time limited. DMT: disease-modifying therapy; MRI: magnetic resonance imaging; MS: multiple sclerosis. *Time frame of 3 months was agreed by the Delphi Panel after completion of the Delphi process.
Figure 3.
Figure 3.
Achievable consensus standards for the timing of key events in a brain health-focused MS care pathway related to (a) referral and diagnosis, (b) priorities following diagnosis, (c) routine monitoring and support, (d) treatment decisions and (e) new symptoms. DMT: disease-modifying therapy; MRI: magnetic resonance imaging; MS: multiple sclerosis.

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Source: PubMed

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