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Informing MS patients on treatment options: a consensus on the process of consent taking

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Abstract

In the last years, change in multiple sclerosis (MS) therapeutic scenario has highlighted the need for an improved doctor-patient communication in advance of treatment initiation in order to allow patient’s empowerment in the decision-making process.

Aims

The aims of our project were to review the strategies used by Italian MS specialists to inform patients about treatment options and to design a multicentre shared document that homogenizes the information about disease-modifying treatment (DMTs) and the procedure of taking informed consent in clinical practice.

Results

The new resource, obtained by consensus among 31 neurologists from 27 MS Centres in Italy with the supervision of a medico-legal advisor, received the aegis of Italian Neurological Society (SIN) and constitutes a step toward a standardized decision process around DMTs in MS.

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Author information

Authors and Affiliations

  1. Department of Neurosciences, San Camillo Forlanini Hospital, Rome, Italy

    C. Tortorella, L. Prosperini & C. Gasperini

  2. Department of Rehabilitation, Mons L Novarese Hospital, Moncrivello, Italy

    C. Solaro

  3. Multiple Sclerosis Center, ASST Valle Olona, PO di Gallarate, (VA), Italy

    P. Annovazzi

  4. Department of Neurosciences, MS Center, Tor Vergata University, Rome, Italy

    L. Boffa

  5. Department of Neurosciences, Mental Health and Sensory Organs Sapienza University Rome, Rome, Italy

    M. C. Buscarinu

  6. I.R.C.C.S. Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy

    F. Buttari & R. Fantozzi

  7. Neurology B, Department of Neurosciences Biomedicine and Movements, University of Verona, Verona, Italy

    M. Calabrese

  8. MS Center (P.C.), City of Health & Science University Hospital, Turin, Italy

    P. Cavalla

  9. Department Medical Science and Public Health, University of Cagliari, Cagliari, Italy

    E. Cocco

  10. Multiple Sclerosis Center, ospedale di Montichiari, Spedali Civili di Brescia, Montichiari, Italy

    C. Cordioli

  11. Neurology Clinic, Multiple Sclerosis Center SS. Annunziata Hospital, Chieti, Italy

    G. De Luca

  12. Clinica Neurologica, Dipartimento di Medicina, Università di Perugia, Perugia, Italy

    M. Di Filippo

  13. Department of Biomedical, Metabolic and Neurosciences, University of Modena and Reggio Emilia, Modena, Italy

    D. Ferraro

  14. Department of Neuroscience, Biomedicine and Movement Sciences, University of Verona, Verona, Italy

    A. Gajofatto

  15. Department of Medical, Surgical, Neurological, Metabolic and Aging Science, University of Campania, Naples, Italy

    A. Gallo

  16. Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University, Naples, Italy

    R. Lanzillo & M. Moccia

  17. Department of Neuroscience, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genova, Genoa, Italy

    A. Laroni

  18. IRCCS Ospedale Policlinico San Martino, Genoa, Italy

    A. Laroni

  19. Clinica Neurologica A.O.U. Policlinico-Vittorio Emanuele Catania, Catania, Italy

    S. Lo Fermo

  20. Neurologia 2-CRESM, AOU San Luigi Gonzaga, Orbassano, Italy

    S. Malucchi

  21. Department of Neurology and Stroke Unit, “A. Cardarelli Hospital”, Naples, Italy

    G. T. Maniscalco

  22. Queen Square MS Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK

    M. Moccia

  23. Istituto di Neurologia, Fondazione Policlinico Universitario ‘A Gemelli’ IRCCS, Rome, Italy

    V. Nociti

  24. Department of Basic Medical Sciences, Neurosciences, and Sense Organs, University of Bari, Bari, Italy

    D. Paolicelli

  25. Ospedale di Vaio, Centro SM, Fidenza, Parma, Italy

    I. Pesci

  26. Department of Biomedicine, Neurosciences and Advanced Diagnostic, Dipartimento di Biomedicina, Neuroscienze e Diagnostica Avanzata, Palermo, Italy

    P. Ragonese

  27. Department of Neurosciences, Imaging and Clinical Sciences, School of Medicine, Institute for Advanced Biomedical Technologies (ITAB), University of Chieti-Pescara “G. d’Annunzio, Chieti, Italy

    V. Tomassini

  28. Division of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, University Hospital of Wales, Cardiff, UK

    V. Tomassini

  29. Neuro-immunology and Neuromuscolar Diseases Unit, IRCCS Foundation Carlo Besta Neurological Institute, Milan, Italy

    V. L. A. Torri Clerici

  30. Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy

    M. Rodegher

  31. SC Medicina Legale AUSL Valle D’Aosta, Aosta, Italy

    M. Gherardi

Authors
  1. C. Tortorella
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  2. C. Solaro
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  3. P. Annovazzi
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  4. L. Boffa
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  5. M. C. Buscarinu
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  6. F. Buttari
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  7. M. Calabrese
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  8. P. Cavalla
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  9. E. Cocco
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  10. C. Cordioli
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  11. G. De Luca
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  12. M. Di Filippo
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  13. R. Fantozzi
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  14. D. Ferraro
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  15. A. Gajofatto
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  16. A. Gallo
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  17. R. Lanzillo
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  18. A. Laroni
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  19. S. Lo Fermo
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  20. S. Malucchi
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  21. G. T. Maniscalco
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  22. M. Moccia
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  23. V. Nociti
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  24. D. Paolicelli
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  25. I. Pesci
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  26. L. Prosperini
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  27. P. Ragonese
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  28. V. Tomassini
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  29. V. L. A. Torri Clerici
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  30. M. Rodegher
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  31. M. Gherardi
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  32. C. Gasperini
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Consortia

on behalf of the RIReMS Group

Corresponding author

Correspondence to C. Tortorella.

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Conflict of interests

CT has received honoraria for advisory board and speaking honoraria from Biogen, Merck, Teva, Serono, Roche, Novaritis and Sanofi-Genzyme. CS received advisory board membership of the following companies: Biogen and Merck Serono; speaking honoraria from Bayer Schering, Biogen, Merck Serono, Almirall, Teva, Genzyme; research grants and support from the Italian MS Society Research Foundation (Fondazione Italiana Sclerosi Multipla). PA honoraria for lecturing and participation in advisory boards and travel expenses for attending congresses and meetings from Merck Serono, Biogen, Teva, Sanofi-Aventis, Almirall, Roche and Novartis. LB has nothing to disclose. MCB received speaking honoraria and/or consultant fees from Biogen, Merck Serono, Sanofi-Genzyme, Teva, Novartis and Roche. FB has served on advisory boards for Teva and Roche and has received travel grants and/or speaker honoraria from Merck Serono, Teva, Biogen, Sanofi-Genzyme and Novartis. MC participated on advisory boards for and received speaker or writing honoraria and funding for travelling from Bayer, Biogen Idec, Genzyme, Merck, Novartis, Roche and Teva. PC has served on scientific advisory boards for Merck Serono, Sanofi-Genzyme and Roche; has received speaker honoraria from Genzyme, Teva, Biogen, Novartis and Merck Serono; has received travel funding from Almirall, Biogen, Sanofi-Genzyme, Novartis, Merck Serono and Teva; and has been a consultant for Teva, Sanofi-Genzyme and Merck Serono. EC served on scientific advisory boards and received honoraria for speaking from Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi-Genzyme and Teva. CC has nothing to disclose. MDF participated on advisory boards for and received speaker or writing honoraria and funding for travelling from Bayer, Biogen Idec, Genzyme, Merck, Novartis, Roche and Teva. RF has served on advisory boards for Roche, Biogen, Novartis, Merck Serono and has received travel grants and/or speaker honoraria from Teva and Sanofi-Genzyme. DF has served on scientific advisory boards for Biogen, Roche and Merck Serono and has received travel grants and/or speaking honoraria from TEVA, Merck, Biogen, Novartis and Sanofi-Genzyme. AG received research funding and advisory board compensation from Merck Serono. AG has nothing to disclose. RL received personal fees and financial support from Almirall, Novartis, Merck Serono, Biogen, Teva and Genzyme. LP received consulting fees from Biogen, Novartis and Roche; speaker honoraria from Biogen, Genzyme, Merck Serono, Novartis and Teva; travel grants from Biogen, Genzyme, Novartis and Teva; and research grants from the Italian MS Society (Associazione Italiana Sclerosi Multipla) and Genzyme. AL received lecturing honoraria from Biogen and Teva; consulting fees from Sanofi-Genzyme, Biogen, Merck and Roche; and funding for travel from Sanofi-Genzyme, Biogen, Merck and Teva. SLF received funding for travel and for advisory board from Genzyme, Biogen Idec, Teva, Merck and Serono. SM has nothing to disclose. GTM received personal compensation from Serono, Biogen and TEVA for public speaking and advisory boards. MM has received research grants from ECTRIMS-MAGNIMS and Merck and honoraria from Biogen, Merck and Sanofi-Genzyme. VN has served on scientific advisory boards for Novartis, Teva, Biogen Idec, Sanofi, Genzyme and Bayer Schering and has received funding for travel and speaker honoraria from Teva, Biogen Idec, Bayer Schering, Merck Serono, Almirall, Genzyme and Novartis. DP received honoraria for consultancy and/or speaking from Biogen Idec, Merck Serono, Bayer Schering, Sanofi-Aventis, Teva, Novartis and Genzyme. IP has nothing to disclose. LP received consulting fees from Biogen, Novartis and Roche; speaker honoraria from Biogen, Genzyme, Merck Serono, Novartis and Teva; travel grants from Biogen, Genzyme, Novartis and Teva; research grants from the Italian MS Society (Associazione Italiana Sclerosi Multipla) and Genzyme. PR received travel expenses or honoraria for consultancy from Merck Serono, Biogen Idec, Novartis, Sanofi-Genzyme and Teva. VT has received research support and honoraria from Biogen Idec and honoraria and travel grants from Biogen Idec and Novartis. VTC received personal compensation from Novartis, Almirall, Genzyme and Teva for public speaking, editorial work and advisory boards. MR has nothing to disclose. MG has nothing to disclose. CG has received compensation for consulting from Bayer HealthCare Pharmaceuticals and Biogen Idec and as a speaker for lectures from Biogen Idec, Bayer HealthCare Pharmaceuticals, Genzyme, Merck Serono, Novartis and Teva Pharmaceutical Industries. RIREMS meetings during the planning and the conduction of the project were supported by an unrestricted contribution by Merck Serono. The sponsor only contributed to the logistics of the meetings but had no role in the planning, the study design or the conduction of the project.

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Tortorella, C., Solaro, C., Annovazzi, P. et al. Informing MS patients on treatment options: a consensus on the process of consent taking. Neurol Sci 41, 2249–2253 (2020). https://doi.org/10.1007/s10072-020-04339-z

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  • DOI: https://doi.org/10.1007/s10072-020-04339-z

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