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Randomized Controlled Trial
. 2018 Apr;24(5):663-674.
doi: 10.1177/1352458517704078. Epub 2017 Apr 6.

Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis

Alessandra Solari  1 , Andrea Giordano  1 , Francesco Patti  2 , Maria Grazia Grasso  3 , Paolo Confalonieri  4 , Lucia Palmisano  5 , Michela Ponzio  6 , Claudia Borreani  7 , Rosalba Rosato  8 , Simone Veronese  9 , Paola Zaratin  6 , Mario Alberto Battaglia  10 ; PeNSAMI Project
Affiliations
Randomized Controlled Trial

Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis

Alessandra Solari et al. Mult Scler. 2018 Apr.

Abstract

Background: Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce.

Objective: To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers.

Methods: 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).

Results: 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.

Conclusion: HPA slightly reduced symptoms burden. We found no evidence of HPA efficacy on patient quality of life and on secondary outcomes.

Keywords: Multiple sclerosis; caregivers; palliative care; quality of life; randomized controlled trial; symptom burden.

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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: A.S. has been a board member of Biogen Idec, Merck Serono and Novartis and has received speaker honoraria from Genzyme, Merck Serono, and Excemed. F.P. received honoraria for speaking activities from Bayer Schering, Biogen Idec, Merck Serono, Novartis, and Sanofi Aventis. He has served as advisory board member of the following companies: Bayer Schering, Biogen Idec, Merck Serono, and Novartis. M.G.G. has received research funding from Merck Serono and consulting and speaking fees from Biogen Idec. P.C. has been a board member of Biogen Idec, received travel grants from Sanofi Aventis, Biogen Dompe, and Merck Serono. P.Z. and M.A.B. are board members of the Fondazione Italiana Sclerosi Multipla (charitable organization). All other authors declare that they have no competing interests.

Figures

Figure 1.
Figure 1.
CONSORT 2010 Flow diagram of the trial. HPA: home-based palliative approach; UC: usual care.
Figure 2.
Figure 2.
The care needs addressed (dark gray, overall n = 338) and fulfilled (light gray, n = 276) as reported by the home-based palliative approach (HPA) teams. Care needs are grouped into 11 pre-set categories and 3 domains.
Figure 3.
Figure 3.
Change in the two primary outcome measures Palliative care Outcome Scale-Symptoms-Multiple Sclerosis (POS-S-MS) and Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW) by intervention group (intention-to-treat data). Point estimates and confidence intervals (CIs) are from the raw data. HPA: home-based palliative approach; UC: usual care.
See this image and copyright information in PMC

References

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