Elsevier

The Lancet Neurology

Volume 5, Issue 7, July 2006, Pages 565-571
The Lancet Neurology

Fast track — Articles
Home versus outpatient administration of intravenous steroids for multiple-sclerosis relapses: a randomised controlled trial

https://doi.org/10.1016/S1474-4422(06)70450-1Get rights and content

Summary

Background

Intravenous steroids are routinely used to treat disabling relapses in multiple sclerosis, and can be administered in an outpatient or home setting. We developed a rating scale that allowed us to compare the two strategies formally in a trial setting.

Methods

Patients who had a clinically significant multiple-sclerosis relapse within 4 weeks of onset were randomly assigned administration of a 3-day regimen of intravenous methylprednisolone either in an outpatient clinic (n=69) or at home (n=69). The MS relapse management scale (MSRMS) was developed to measure patients' experiences of relapse management as the primary outcome. Efficacy of the two treatment modalities was compared in terms of traditional measures and economic cost. A cost-minimisation analysis was also done. Analysis was by intention to treat.

Findings

Of 149 eligible patients, 138 consented to participate in the trial and were randomly assigned to a treatment group. Coordination of care was significantly better in the home-treatment group (median score 4·5 [IQR 3·0–11·4]) than in the hospital-treatment group (12·1 [3·0–18·6]; p=0·024). The other dimensions of the MSRMS did not differ between groups (p>0·10). Administration of steroids was equally safe and effective in either location, and cost was either the same or cheaper when delivered at home than when delivered in hospital.

Interpretation

Treatment of relapses in multiple sclerosis with intravenous steroids can be effectively and safely administered at home, from both patient and economic perspectives. Moreover, the trial indicates the importance of explicit and valid outcome measures of all aspects of service delivery when making decisions about health policy. This finding has implications for complex service delivery care models for long-term diseases.

Introduction

There is clear evidence that the streamlined management of chronic diseases can reduce crises and deterioration and improve quality of life of those affected.1 Essential components of good chronic-disease management include: involving people in their own care; coordination of care; multidisciplinary teamwork; integration of specialist and generalist expertise, including cross-boundary working, with the ultimate aim of reducing unnecessary visits and admissions; and provision of care in the least intensive setting.2 Disease-specific guidance from the National Institute for Clinical Excellence3 coupled with the National Service Framework for long term conditions4 underpin this approach in the UK.

Multiple sclerosis affects more than 80 000 people in the UK. For 85% of patients, the disease is characterised initially by symptomatic relapses and remissions. For 40%, this course is followed by a more progressive phase,5 which can include superimposed relapses. About 8000–10 000 relapses are estimated to occur in the UK per annum,6 of which 40% of patients make an incomplete recovery.7 These relapses are unpredictable in onset and duration and have a clear effect on quality of life, family and work activity, health resources, and economic loss. Corticosteroids are the mainstay of treatment for disabling multiple sclerosis, and for every 1000 patients treated with steroids 247 more patients improve compared with those treated with placebo (95% CI 144–349).8, 9 In accord with this analysis, a survey of practice in the UK10 showed that intravenous steroids are commonly prescribed (>50%) for relapses, with the most popular regimen (75% of respondents) being 1g per day of methylprednisolone for 3 days. Although methylprednisolone can be administered orally (avoiding the need for hospital-based care), the side-effect profile of intravenous methylprednisolone is better, with less gastrointestinal and psychiatric disorders than the oral formulation.8 Trials that have directly compared routes of administration have been too small to yield definitive conclusions.6, 8, 11, 12

In the UK, intravenous methylprednisolone is rarely given at home. By contrast, this practice is accepted for other intravenous therapies, such as chemotherapy, with clear benefits in compliance, satisfaction, and cost. In one study, for example, people receiving chemotherapy for colonic cancer were randomised to either outpatient or home-care delivery. Treatment toxicity was the same in both groups, but withdrawal symptoms were less common and patient satisfaction was greater in the home-care group than in the outpatient group.13 The case for exploring the location of delivery of intravenous steroids in the treatment of disabling relapses of multiple sclerosis is therefore clear, especially when considered within the context of a UK health service, which is reforming to improve chronic-disease management. The service, however, should be assessed from a patient perspective with a valid measure of the aspects of relapse management that are important to people with multiple sclerosis. We aimed to develop an appropriate rating scale to formally compare delivery of intravenous steroids in a home and an outpatient setting.

Section snippets

Patients

All patients were seen in the relapse clinic at the National Hospital for Neurology and Neurosurgery, London, UK. Patients were eligible for inclusion in the trial if they were older than 18 years, had clinically definite multiple sclerosis,14, 15 and had sustained a definite relapse of more than 24 h but less than 4 weeks in duration. Patients were excluded if: their relapse was minor, such that the clinician would not prescribe steroids; their relapse was severe enough to need

Results

Of the 285 patients seen in the relapse clinic between September, 2003, and April, 2005, 138 were randomised in the trial (figure). Table 2 shows patients' characteristics in each study group. Baseline data did not differ between the groups and were representative of a typical sample of patients with multiple sclerosis.

Coordination of care was significantly better in the home-treatment group than in the hospital-treatment group. However, there was no difference for the other three dimensions of

Discussion

This study set out to examine, from the patient's perspective, whether the acute treatment of multiple sclerosis relapses with intravenous steroids should take place in secondary care or at home. Overall, our findings lend support to the home administration of a treatment that has traditionally been administered in a hospital setting. Home administration is cheaper than outpatient administration from the NHS perspective, although these savings are sensitive to assumptions about unit costs and,

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