title: Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis.
abstract: Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce.
  
  
  
  To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers.
  
  
  
  Adults with severe MS-carer dyads were assigned (2:1 ratio) to either HPA or usual care (UC). At each center, a multi-professional team delivered the 6-month intervention. A blind examiner assessed dyads at baseline, 3 months, and 6 months. Primary outcome measures were Palliative care Outcome Scale-Symptoms-MS (POS-S-MS) and Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW, not assessed in severely cognitively compromised patients).
  
  
  
  Of 78 dyads randomized, 76 (50 HPA, 26 UC) were analyzed. Symptom burden (POS-S-MS) significantly reduced in HPA group compared to UC ( p = 0.047). Effect size was 0.20 at 3 months and 0.32 at 6 months, and statistical significance was borderline in per-protocol analysis ( p = 0.062). Changes in SEIQoL-DW index did not differ in the two groups, as changes in secondary patient and carer outcomes.
  
  
  
  HPA slightly reduced symptoms burden. We found no evidence of HPA efficacy on patient quality of life and on secondary outcomes.
authors.affiliation: Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Solari
authors.affiliation: Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Giordano
authors.affiliation: MS Centre, Neurology Clinic, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
authors.affiliation: Multiple Sclerosis Unit, IRCCS S. Lucia Foundation, Rome, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Grasso
authors.affiliation: Department of Neuroimmunology and Neuromuscular Diseases, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Confalonieri
authors.affiliation: National Center for Drug Evaluation and Research, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Palmisano
authors.affiliation: Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genoa, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Ponzio
authors.affiliation: Unit of Clinical Psychology, Foundation IRCCS Istituto Nazionale per la Cura dei Tumori, Milan, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Borreani
authors.affiliation: Department of Psychology, University of Turin, Turin, Italy.
authors.forename: Rosalba
authors.initials: R
authors.lastname: Rosato
authors.affiliation: FARO Charitable Foundation, Turin, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Veronese
authors.affiliation: Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genoa, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Zaratin
authors.affiliation: Department of Life Sciences, University of Siena, Siena, Italy.
authors.forename: Mario Alberto
authors.initials: MA
authors.lastname: Battaglia
mesh_terms: D000203:Activities of Daily Living; D000359:Aftercare; D000368:Aged; D017028:Caregivers; D018450:Disease Progression; D005260:Female; D006699:Home Care Services; D018577:Homebound Persons; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D015999:Multivariate Analysis; D010166:Palliative Care / Q000379:methods*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: Multiple sclerosis; caregivers; palliative care; quality of life; randomized controlled trial; symptom burden