The Management of Acute Relapses of Multiple Sclerosis in Malta

Multiple Sclerosis (MS) is a complex, progressive and lifelong neurological disorder defined by demyelinating lesions within the brain and spinal cord, these lesions are characteristically disseminated in time and place. Formation of such lesions may coincide with a clinically apparent "acute relapse", in essence, a sudden deterioration in neurological function.

Prevalence of clinically probable Multiple Sclerosis (MS) in Malta has grown from 4.2/100,000 in 1978 to 16.7/100,00 in 1999. It is currently estimated that approximately 320 people suffer from MS in Malta.^1-2

The purpose of this audit was to assess whether acute relapses of MS are being treated in accordance to the recommended NICE October 2014 guidelines, with the ultimate aim being improvement of the quality of care experienced by MS patients in Malta. Furthermore, the lack of a Multiple Sclerosis specialist nurse within the multidisciplinary team has raised questions on the current clinical care is prompt and adequate for acute relapses of Multiple Sclerosis

Materials and Methods

Data collection was carried out prospectively over a period of 9 months in 2016. Patients were recruited from the Multiple Sclerosis Clinic and the Medical Therapy Unit at Mater Dei Hospital.  Patients who were recruited to the study attended a one-on-one interview with a single assigned medical doctor equipped with a standardized questionnaire.

The Questionnaire used was based on the “NICE Guidelines: Management of Multiple sclerosis in primary and secondary care” issued in 2014 as best practice. The area of the NICE guidelines we focused on in our audit was section 1.7 (Relapse and Exacerbation). We used this section to produce a questionnaire that was used as framework for the interview. This questionnaire and quoted section from guidelines are demonstrated below the references in the boxes below.  

Patients were also given the freedom to add their personal comments and feedback during the interview. Patients included in the study were recruited opportunistically provided that they met the inclusion criteria below.

Information letter for patients in both English and Maltese language were distributed, in addition, Consent was obtained from each patient. Ethical Approval was sought from the local Ethics committee.

Inclusion criteria

We included patients meeting the McDonald criteria for the diagnosis of MS. ³ Only patients who were diagnosed with MS after 2004 were included, and only those who had presented with an acute relapse from 2008 to 2016. Patients below 18 years of age were excluded. In order to minimize recall bias, data collection was carried out for the single latest relapse, Figure (1) illustrates the date of relapses selected. Data analysis was carried out using SPSS. 

Results

A total of 35 Patients met the inclusion criteria. The mean age of patients recruited was 39. The male to female ratio was 2:3, and the majority of patients (29) had a Relapsing Remitting MS Course, while the remainder (6) had a Clinically Isolated Syndrome (CIS).

Recognition of Relapse

A true acute relapse is defined as neurological deficit lasting for >24 hours in the absence of infection, as stipulated in the 2010 McDonald Criteria. ³

Of all the patients interviewed, 86% of them met the appropriate diagnostic criteria of an acute MS relapse. Most relapses assessed occurred in 2016 as shown in Figure 1.

Table 1 summarizes the results of the relapse awareness from our questionnaire. Clinically isolated syndrome refers to patients diagnosed with MS after a single episode of acute MS relapse.

Over 34% of patients showed a delay of more than 14 days in the time to treatment from the initial onset of symptoms as illustrated by Figure 2.

Figure 2

Time from onset of symptoms to treatment

For the patients who received IV steroids, Figure 3 shows the total duration of treatment given. The most common duration was 5 days, a maximum of 7 days and a minimum of one day. only 2 patients did not receive methylprednisolone.

Figure 3

Total duration of IV methylprednisolone given during relapses

Treating a Relapse

89% (31) of patients received IV Methylprednisolone as treatment for their relapse. Treatments given, including doses and duration are shown in Table 2. The remaining 11% (4) of patients did not receive any treatment for their relapse.

Almost one third of patients required inpatient treatment, the breakdown of length of stay and reason for admission is shown in Table 3. Patient are usually admitted in view of a severe disabling relapse, monitoring of a medical or psychiatric condition, or due to poor social support.

Information about treating a relapse

We aimed to appraise the basic knowledge of patients on steroid treatment. 47% of patients reported lack of awareness of potential drug adverse effects. 50% claimed that they did not receive any formal discussion with a health care professional regarding risks and benefits treatment. 74% did not receive any formal patient information (e.g. leaflets, website sign-posting) regarding the recognition of relapse.

Medical, therapy and social care needs at time of relapse or exacerbation

33% of patients were referred to a rehabilitation facility (Physiotherapy, Occupational therapy, Speech Language Pathology).

Discussion

At the outset of this audit, we wanted to assess whether the current practice in Malta meets the quality standards set out by NICE guidelines for the management of MS in 2016. ⁶

Results show that the overwhelming majority of patients are referred for first line treatment once they are recognized as having an acute relapse. However, it has been identified that service provision can be optimized in, but not limited to, the following areas:

1. It is clear that among some patients there is a delay in access to treatment, thus more timely recognition of those patients in an acute relapse is required. This study demonstrates that of all patients receiving first line treatment, 34% of them received treatment outside the recommended 14-day window suggested by the guidelines. Therefore, identification of the barriers to access in a manner medical attention is an area for further study.
2. MS relapses maybe overlooked by patients and can be confused with symptom fluctuation, as our study showed that 11% of patients did not receive any treatment for their clinically significant relapse symptoms. this highlights the importance of patient education especially with regards to MS relapses. This aspect of MS care is not well documented in the research literature, however, a nursing qualitative study Ross AP et al.⁴ recognizes this overlooked issue.
3. This study further elucidated that 47% of patients reported no recollection of a discussion about the potential advantages and disadvantages of commencing steroid treatment and hence constitutes the second area identified for optimization. It is of paramount importance for patient safety that patients are made aware of the most relevant risks and benefits of steroid treatment. However, it is sometimes impractical to have lengthy discussions regarding risk benefit. Patients who receive timely steroid treatment do not necessarily improve, in fact, almost one third perceive the outcomes to be worse on account of the treatment, according to a large-scale observational study carried out by Nickerson et al. ⁵

The limitations of this audit included a small sample size and retrospective data collection. A larger sample size and prospective data collection will provide us with stronger evidence to further support the findings. Furthermore, data collected depended on the recollection of relapses by patients, prospective collection and review of clinical notes may provide a more accurate information and minimize recall bias.

Recommendations

As a result of the qualitative findings, we are proposing 3 recommendations to improve patient care in accordance with best practice as set out by NICE guidelines ⁶ in the management of MS:

1. To improve patient knowledge in recognizing relapse and to expedite access to treatment. Patients could be provided with a 'MS Passport' listing most common symptoms, well as including contact details of a named individual, e.g., MS nurse specialist, to contact if such symptoms occur.
2. To provide adequate and comprehensive information on the risks and benefits of steroid treatment and that these should be made available to patients in an accessible format at the earliest point of contact, ideally prior to acute flares. This could be in the form of patient information leaflets.
3. To introduce a MS Specialist nurse to the Multi-disciplinary team in order provide vital support to patients with MS in Malta.

Summary

What is already known:

1. MS is associated with high levels of morbidity
2. Acute Relapses require prompt assessment and may be mimicked by infection, or chronic symptom fluctuations

What are the new findings?

1. A third of acute MS relapses may go unrecognized or present late
2. Patient education and access to specialist nurse is recommended in Malta

References

1. Dean G, Elian M, de Bono AG, et al. Multiple sclerosis in Malta in 1999: an update.  J. Neurol Neurosurg Psychiatry 2002;73(3):256-260. doi:10.1136/jnnp.73.3.256. https://sci-hub.tw/10.1136/jnnp.73.3.256
2. Article: Vassallo L, Elian M, Dean G. Multiple sclerosis in southern Europe. II: Prevalence in Malta in 1978 J Epidemiol Community Health. 1979 Jun;33(2):111-3.
3. Article: Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Annals of Neurology 2011;69(2):292-302. doi:10.1002/ana.22366. https://sci-hub.tw/10.1002/ana.22366
4. Ross AP, Halper J, Harris CJ. Assessing Relapses and Response to Relapse Treatment in Patients with Multiple Sclerosis: A Nursing Perspective. International Journal of MS Care. 2012;14(3):148-159. doi:10.7224/1537-2073-14.3.148. https://ijmsc.org/doi/full/10.7224/1537-2073-14.3.148
5. Nickerson M, Marrie RA. The multiple sclerosis relapse experience: patient-reported outcomes from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. BMC Neurol. 2013;13:119. doi:10.1186/1471-2377-13-119 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848753/
6. Multiple sclerosis in adults: management. NICE Clinical guideline Published: 8 October 2014 www.nice.org.uk/guidance/cg186

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