Dataset Information

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

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.

SUBMITTER: Solari A

PROVIDER: S-EPMC5946675 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Publications

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

Solari Alessandra A Giordano Andrea A Patti Francesco F Grasso Maria Grazia MG Confalonieri Paolo P Palmisano Lucia L Ponzio Michela M Borreani Claudia C Rosato Rosalba R Veronese Simone S Zaratin Paola P Battaglia Mario Alberto MA

Multiple sclerosis (Houndmills, Basingstoke, England) 20170406 5

<h4>Background</h4>Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce.<h4>Objective</h4>To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers.<h4>Methods</h4>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 month ...[more]

PMID: 28381133

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Project description:BackgroundWe performed a qualitative study to investigate the experiences of participants in a multicentre randomized controlled trial on a home-based palliative approach (HPA) for adults with severe multiple sclerosis (MS) and their caregivers. Our aim was to explore the strengths and challenges of the intervention, and circumstances that may have influenced its efficacy.MethodsParticipants to the qualitative study were the patients, their caregivers, patient referring physicians, and the teams who delivered the HPA intervention. We performed semi-structured one-on-one interviews with 12 patients and 15 informal caregivers chosen using a maximum variation strategy, two focus group meetings with patient referring physicians (4 participants each), and one with the HPA teams (9 participants).ResultsFrom data analysis (framework method) 38 sub-categories emerged, which were grouped into 10 categories and 3 themes: 'expectations,' 'met and unmet needs', and 'barriers'. Intervention benefits were improved control of symptoms and reduced sense of isolation of the patient-caregiver dyads. Limitations were: factors related to experimental design (difficulty of dyads in identifying examiner and team roles, additional burden for caregivers); team issues (insufficient team building /supervision, competing priorities); limitations of the intervention itself (insufficient length, lack of rehabilitation input); and external factors (resource limitations, under-responsive services/professionals). The referring physician focus groups provided little experiential data.ConclusionsThe HPA reduced patient symptoms and sense of isolation in patients and caregivers. The indirect role of the HPA teams, and insufficient length of the intervention were key limitations. The experimental design imposed additional burdens on the dyads. Key barriers were the paucity of available services, the demanding administrative procedures, and lack of networking facilities. These findings suggest that two major requirements are necessary for home palliative care to be effective in this patient population: HPA teams well-connected with MS rehabilitation services, and care delivered over the long-term, with variable intensity.Trial registrationCurrent Controlled Trials ISRCTN73082124 (Registered 19/06/2014).

Project description:BACKGROUND: Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom. METHODS: We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11 days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients' perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue. RESULTS: Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabis resulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial. INTERPRETATION: Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact.

Dataset Information

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

Background

Objective

Methods

Results

Conclusion

Publications

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

Similar Datasets

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