Mario Alberto Battaglia

Costs and quality of life of multiple sclerosis in Germany

This cost-of-illness analysis based on information from 921 patients in Italy is part of a Europe-wide cost-of-illness study in multiple sclerosis (MS). The objective was to analyze the costs and quality of life (QOL) related to the level of disease severity and progression. Patients registered with the Italian MS patient organization were asked to participate in a mail survey, and 31% responded. The questionnaire asked for details on the disease (type of disease, relapses, level of functional disability), information on all medical and non-medical resource consumption, and informal care and work capacity (sick leave and early retirement). In addition, patients were asked about their current QOL (in the form of utility) and the level of fatigue. The mean age of respondents was 46 years, and 8.5% were 65 years or older. As many as 20% of patients had severe disease (Expanded Disability Status Scale [EDSS] score of ≥7), 47% had moderate disease (EDSS score of 4–6.5) and only 31% had mild disease (EDSS score of 0–3). Thus, the mean EDSS score in the sample was 4.6 (median 5.0), with a utility of 0.53 (range: 0 = death to 1 = full health) and a fatigue level of 6.4 (range: 1 = not tired to 10 = extremely tired). Costs and utility are highly correlated with disease severity. Workforce participation decreases from approximately 80% in early disease to less than 10% in the very late stages. Total costs increase fivefold between an EDSS score of 0–1 and a score of 7. Health-care costs, however, show a limited increase with worsening disease – hospitalization increases from € 800 per patient to € 3200, and ambulatory care increases from € 900 to € 1500. Productivity losses, on the other hand, increase by a factor of 12, while informal care increases from € 500 at an EDSS score of 0–1 to nearly € 25 000 at an EDSS score of 7, and € 39 000 at an EDSS score of 8–9. Hence, total mean costs per patient are determined essentially by the distribution of the severity levels in the sample, increasing from € 12 000 at an EDSS score of 0–1 to € 57 000 at an EDSS score of 7, and € 71 000 at an EDSS score of 8–9. The same is true for utility, which decreases from 0.80 to 0.06 as the disease becomes severe. However, the utility loss compared to the age- and gender-matched general population is high at all levels of the disease, leading to an estimated annual loss of 0.3 quality-adjusted life year (QALY) per patient. Relapses for patients with an EDSS score of <5 are associated with a cost of approximately € 4000 and a utility loss of 0.18 during the quarter in which they occur.

An interdisciplinary approach to evaluating the need for assistive technology reduces equipment abandonment

Assistive technology makes up a substantial portion of the direct cost of multiple sclerosis (MS). Equipment abandonment results in the needs of the disabled individual being unmet and places stress on the resources available for the funding of such equipment. The aim of the study was to demonstrate whether an interdisciplinary approach to evaluating and prescribing assistive technology reduces equipment abandonment in persons with MS. Data concerning assistive devices acquired by patients being followed at a rehabilitation centre in northern Italy from January 1997 to December 2002, were included in the study. Through December 1999, a physician in physical medicine and rehabilitation prescribed equipment based on a recommendation from the physical therapist. From 2000 to 2002, patients were evaluated following a standardized protocol implemented by an interdisciplinary team comprised of a physical therapist, occupational therapist, physician in physical medicine and rehabilitation and psychologist. Assistive technology obtained during the study period was divided into two datasets based on the year that the aid was obtained: pre-intervention (January 1997 to December 1999) and intervention (January 2000 to December 2002). The analysis included a comparison of the two datasets on number and types of equipment abandoned, timing of abandonment and reasons why devices were abandoned. Fifty-four subjects obtained 151 assistive devices during the study period, 67 devices during pre-intervention and 84 with the intervention. The majority of devices were abandoned immediately or within the first year following obtainment in both groups. A comparison of the number of devices obtained during pre-intervention with those obtained during the intervention showed that the rate of equipment abandonment decreased significantly from 37.3 to 9.5%. An interdisciplinary approach to evaluating assistive technology needs does decrease the risk of equipment abandonment, although it does not completely solve the problem.

The costs of multiple sclerosis: a cross-sectional, multicenter cost-of-illness study in Italy

Objectives To estimate the socio-economic impact of multiple sclerosis (MS) in Italy. Methods Outpatients with MS were enrolled at 44 centres across Italy. Socio-demographic, clinical and resource utilization data were collected using a validated questionnaire. Each patient completed a weekly diary of expenses due to MS over a three-month period. Direct health care costs and indirect costs (lack of productivity for the patient and for caregivers) were assessed for the whole population and were compared among five groups, categorised by disease severity (EDSS score). An analysis of variance was carried out on socio-demographic variables. Results For the total population of 566 patients, the mean direct cost over three months was ITL 2,134,000, the mean indirect cost was ITL 7,775,000. Costs were significantly higher for male patients (p < 0.05) and showed a significant increase with increasing age (p < 0.0005), disease duration (p < 0.0005) and disease severity (p < 0.0005). Costs for patients in a progressive phase were significantly higher (p < 0.0005). There were no significant geographical differences among the regions of Italy. Conclusions This study confirms that MS represents a high economic burden, with indirect costs greatly exceeding direct costs. Unpaid caregivers remain the culturally accepted mode of care for MS patients in Italy and this study illustrates the impact of their loss of earnings. As costs increase with disease progression, these findings suggest that treatment efforts should focus on patients in the early stages of MS, in order to slow down disease progression.

Home based management in multiple sclerosis: results of a randomised controlled trial

Background: Home based medical care is a popular alternative to standard hospital care but there is uncertainty about its cost-effectiveness. Objectives: To compare the effectiveness and the costs of multidisciplinary home based care in multiple sclerosis with hospital care in a prospective randomised controlled trial with a one year follow up. Methods: 201 patients with clinically definite multiple sclerosis were studied. They were randomised in a ratio 2:1 to an intervention group (133) or a control group (68). They were assessed at baseline and one year after randomisation with validated measures of physical and psychological impairment and quality of life (SF-36 health survey). The costs to the National Health Service over the one year follow up were calculated by a cost minimisation analysis. Results: There were no differences in functional status between the home based care group and the hospital group. There was a significant difference between the two groups favouring home based management in four SF-36 health dimensions—general health, bodily pain, role-emotional, and social functioning (all p ≤ 0.001). The cost of home based care was slightly less (822 euros/patient/year) than hospital care, mainly as a result of a reduction in hospital admissions. Conclusions: Comprehensive planning of home based intervention implemented by an interdisciplinary team and designed specifically for people with multiple sclerosis may provide a cost-effective approach to management and improve the quality of life.

Caregiver quality of life in multiple sclerosis: a multicentre Italian study:

The purpose of this study was to evaluate the quality of life (QoL) of multiple sclerosis (MS) caregivers, and to determine relationships that may exist between caregiver and patient QoL. Patients with definite MS (n=445) and their caregivers (n=445) were required to complete the generic, 36-item short-form (SF-36) Health Survey. Median SF-36 dimension scores ranged from 55 to 100 for caregivers and from 46 to 78 for patients. Although the QoL of MS carers was not as severely affected as that of patients, caregiving was associated with lower mental health, vitality and general health scores, compared to healthy subjects. Multivariate analyses revealed significant differences between the predictors of patient QoL and caregiver QoL. The main predictors of patient QoL were Expanded Disability Status Scale (EDSS) score, MS course, fatigue and depression. Female gender and advanced age were the main predictors of lower QoL in caregivers. In addition, patient BDI score was found to be a significant predictor of almost all caregiver SF-36 dimension scores, while EDSS score, disease duration and course, and patient therapeutic characteristics were found to be predictors of some caregiver SF-36 dimension scores. Therefore, caregiver QoL was significantly influenced by patient characteristics, and supportive strategies for MS caregivers are warranted. Multiple Sclerosis 2007; 13: 412-419. http://msj.sagepub.com

The effect of Nintendo® Wii® on balance in people with multiple sclerosis: a pilot randomized control study

Improvement of sensory strategies is a relevant part of balance rehabilitation in multiple sclerosis (MS). This study aimed to Assess the effectiveness of visual-feedback exercises in improving balance in MS. We divided 36 patients into Wii and control-treated groups that underwent balance rehabilitation. Outcomes were obtained for Berg Balance Scale (BBS), Modified Fatigue Impact Scale, and sway area under conditions of opened and closed eyes. BBS showed a statistically significant improvement (from 49.6 to 54.6 points, p < 0.05) in the Wii group. Interactive visual-feedback exercises such as Wii could be more effective than the current standard protocol in improving balance disorders in MS.

Factors that influence the employment status of people with multiple sclerosis: a multi-national study.

Paid employment is valuable for society and for the individual. A diagnosis of a chronic illness such as multiple sclerosis (MS) can influence a person’s employment status. Previous studies have reported that demographic and disease-related aspects can predict whether a person with MS will leave their job. The aim of the study was to assess the factors that people with MS believe to contribute to their employment status and to determine whether any of these differentiate people with MS who are employed from those who are not employed. A multi-national questionnaire assessed aspects related to employment that facilitate or hinder job maintenance. Data was collected in 18 European countries. A total of 1,141 questionnaires were completed. Of those responding, 694 (61%) subjects were employed and 477 (39%) were unemployed. The items that significantly differentiated the groups were related to MS symptoms, workplace environment and financial considerations. While MS influences employment status for many people who face difficult symptoms, aspects like a flexible work schedule and financial security are important and perhaps key to promoting job maintenance among people with MS.

Peer support groups in multiple sclerosis: current effectiveness and future directions

Peer support programs have become a common method of providing support for patients with chronic illness. Utilizing peers as resources has been proposed as an effective means for coping with a stressful life experience and for gaining support from others who share a common factor, although data are somewhat mixed on the efficacy of peer support. The aim of the present study was to evaluate the effectiveness of eight weeks of a standard form of peer support in improving quality of life and reducing depressive symptoms in 44 patients with multiple sclerosis (MS). O ne person from each of six groups participated in a training course in order to learn basic principles of peer support. Eight weekly sessions were held and patients completed self-administered questionnaires pre- and post- treatment assessing quality of life and depression. Results showed that support groups do not provide consistent improvement in quality of life or depression in patients with MS and suggest that patients who have better mental health functioning could be at risk for deterioration in support groups.

The FIM instrument in the United States and Italy: a comparative study.

Tesio L, Granger CV, Perucca L, Franchignoni FP, Battaglia MA, Russell CF: The FIM™ instrument in the United States and Italy: A comparative study. Am J Phys Med Rehabil 2002;81:168–176. ObjectiveTo compare FIM™ instrument ratings between Italy and the United States. DesignThis study utilized 169,835 United States and 4,536 Italian FIM instrument records for stroke with the left side of the body affected, stroke with the right side of the body affected, and orthopedic conditions. ResultsCase-mix, patient age, and admission and discharge FIM instrument scores were similar. The delays between onset of disability and admission to rehabilitation and lengths of stay in rehabilitation were 2–4 times longer in Italy. In Italy, some 88–95% of the subjects were discharged to the community vs. 74–88% in the United States. Hierarchies of FIM instrument ratings across the motor and cognitive items were similar, but there were interesting differences. The hierarchical patterns showed that dressing, bathing, perineal hygiene, and tub or shower transfer were relatively more difficult in Italy compared with the Unites States, whereas walking was easier in Italy compared to the United States. ConclusionThe Italian health care payment system offers less incentive for early discharges from acute care and rehabilitation. In Italy, nursing homes are less accessible, whereas family support is more available. Apparently less intensive treatment is applied in Italy, where a minimum time per day for rehabilitation services is not mandatory for payment. Occupational therapy is not used in Italy and the focus is more on physical therapy.

Antiepileptic medications in multiple sclerosis: adverse effects in a three-year follow-up study.

Neuropathic pain and paroxysmal symptoms are common in multiple sclerosis (MS) patients, although no double-blind clinical trial has been conducted to support antiepileptic medications (AED) use in MS. The aim of the study was to evaluate the frequency of AED utilisation and reported adverse events, in a cohort of MS patients. For a period of 3 years the rationale for prescribing AED, adverse effects, treatment duration and reasons for discontinuation were recorded in a database. Carbamazepine (CBZ) was prescribed in 36 patients, with adverse effects reported in 20 cases, of which 12 mimicked a relapse. Gabapentin (GBP) was prescribed in 94 patients, with adverse effects reported in 16 cases and in one case mimicked a relapse. Lamotrigine (LMT) was prescribed in 22 patients, with adverse effects reported in 4 cases, none mimicking a relapse. The present study found a significantly higher incidence of adverse effects in patients treated with CBZ, with a high rate of discontinuation at low dosages and episodes of evident worsening of neurological functioning compared to GBP or LMT.