Trial reportTrials2015
Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- EAN Guideline on Palliative Care of People with Severe, Progressive Multiple Sclerosis.Journal of palliative medicine · 2020Guideline
- The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers.The Cochrane database of systematic reviews · 2020Pooled it
- Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2018Trial
- Participant perspectives of a home-based palliative approach for people with severe multiple sclerosis: A qualitative study.PloS one · 2018Trial
- A systematic review of mortality and long-term functional outcomes after decompressive craniectomy for acquired brain injury: The missing rehabilitation reporting.AIMS neuroscience · 2026Review
- Palliative care interventions for people with multiple sclerosis.The Cochrane database of systematic reviews · 2019Review
- Domains of quality of life freely expressed by cancer patients and their caregivers: contribution of the SEIQoL.Health and quality of life outcomes · 2017Article
- Article
- Individualized quality of life of severely affected multiple sclerosis patients: practicability and value in comparison with standard inventories.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2016Article
- Need for palliative care for neurological diseases.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2016Review
- Article
- Article
- Defining the Role of Physiotherapy in Palliative Care in Multiple Sclerosis.Indian journal of palliative careArticle
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPreliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers. METHODS/
designThis is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient's caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner's visits and telephone interviews, but not the team visits. Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths. The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients' caring physicians). DISCUSSION: The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention.
trial registrationThe trial was registered with Current Controlled Trials (identifier: ISRCTN73082124) on 19 June 2014.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.