High-dose methylprednisolone for acute traumatic spinal cord injury: A meta-analysis.

OBJECTIVE: Due to the continuing debates on the utility of high-dose methylprednisolone (MP) early after acute spinal cord injury (ASCI), we aimed to evaluate the therapeutic and adverse effects of high-dose MP according to the second National Acute Spinal Cord Injury Study (NASCIS-2) dosing protocol in comparison to no steroids in patients with ASCI by performing a meta-analysis on the basis of the current available clinical trials. METHODS: We searched PubMed and Cochrane Library (to May 22, 2018) for studies comparing neurologic recoveries, adverse events, and in-hospital costs between ASCI patients who underwent high-dose MP treatment or not. Data were synthesized with corresponding statistical models according to the degree of heterogeneity. RESULTS: We enrolled 16 studies (1,863 participants) including 3 randomized controlled trials (RCTs) and 13 observational studies. Pooled results indicated that MP was not associated with an increase in motor score improvement (RCTs: p = 0.84; observational studies: p = 0.44) and incidence of recovery by at least one grade on the American Spinal Injury Association Impairment Scale or Frankel (p = 0.53). Meanwhile, MP did not lead to better sensory recovery (p = 0.07). However, MP was associated with a significantly higher incidence of gastrointestinal hemorrhage (p = 0.04) and respiratory tract infection (p = 0.01). The difference in the overall in-hospital costs between MP and control groups was not statistically significant (p = 0.78). CONCLUSIONS: Based on the current evidence, high-dose MP treatment, in comparison to controls, does not contribute to better neurologic recoveries but may increase the risk of adverse events in patients with ASCI. Therefore, we recommend against routine use of high-dose MP early after ASCI.

Incorporating Clinical Practice Guidelines and Quality Measures Into High-Quality Cost-Effective Care for Patients With Multiple Sclerosis.

This article presents a hypothetical case of a patient with multiple sclerosis (MS), reviewing the use of clinical practice guidelines and incorporation of quality measures into practice. Appropriate diagnosis of MS is important to avoid the cost and consequences of a misdiagnosis. Ensuring that treatment discussion occurs when a patient with MS is receptive is good clinical practice and a guideline recommendation from the American Academy of Neurology. Continuing dialogue about disease-modifying therapy and ongoing monitoring are important for patient care and improved outcomes. Ultimately, cost-effective care in MS relates to using appropriate medicines in patients with active MS, ensuring adherence, and careful monitoring.

Outcomes and cost-effectiveness of ultrasound-guided injection of the trochanteric bursa.

We hypothesized that ultrasound (US) guidance improves outcomes of corticosteroid injection of trochanteric bursitis. 40 patients with greater trochanteric pain syndrome defined by pain to palpation over the trochanteric bursa were randomized to injection with 5 ml of 1% lidocaine and 80 mg of methylprednisolone using (1) conventional anatomic landmark palpation guidance or (2) US guidance. Procedural pain (Visual Analogue Pain Scale), pain at outcome (2 weeks and 6 months), therapeutic duration, time-to-next intervention, and costs were determined. There were no complications in either group. Ultrasonography demonstrated that at least a 2-in (50.8 mm) needle was required to consistently reach the trochanteric bursa. Pain scores were similar at 2 weeks: US: 1.3 ± 1.9 cm; landmark: 2.2 ± 2.5 cm, 95% CI of difference: - 0.7 < 0.9 < 2.5, p = 0.14. At 6 months, US was superior: US: 3.9 ± 2.0 cm; landmark: 5.5 ± 2.6 cm, 95% CI of difference: 0.8 < 1.6 < 2.4, p = 0.036. However, therapeutic duration (US 4.7 ± 1.4 months; landmark 4.1 ± 2.9 months, 95% CI of difference - 2.2 < - 0.6 < 1.0, p = 0.48), and time-to-next intervention (US 8.7 ± 2.9 months; landmark 8.3 ± 3.8 months, 95% CI of difference - 2.8 < - 0.4 < 2.0, p = 0.62) were similar. Costs/patient/year was 43% greater with US (US $297 ± 99, landmark $207 ± 95; p = 0.017). US-guided and anatomic landmark injection of the trochanteric bursa have similar 2-week and 6-month outcomes; however, US guidance is considerably more expensive and less cost-effective. Anatomic landmark-guided injection remains the method of choice, but should be routinely performed using a sufficiently long needle [at least a 2 in (50.8 mm)]. US guidance should be reserved for extreme obesity or injection failure.

The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol.

BACKGROUND: Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints. Secondary objectives are to determine specified comparative clinical outcomes and cost effectiveness of corticosteroid injection over 6 and 24 months. METHOD/DESIGN: A multicentre, randomised, parallel group, clinical pragmatic trial will recruit 240 adults aged ≥18 years with mild to moderate CTS from GP Practices and Primary-Secondary Care Musculoskeletal Interface Clinics. Diagnosis will be by standardised clinical assessment. Participants will be randomised on an equal basis to receive either one injection of 20 mg Depo-Medrone or a night splint to be worn for 6 weeks. The primary outcome is the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. Secondary outcomes are the BCTQ symptom severity and function status subscales, symptom intensity, interrupted sleep, adherence to splinting, perceived benefit and satisfaction with treatment, work absence and reduction in work performance, EQ-5D-5L, referral to surgery and health utilisation costs. Participants will be assessed at baseline and followed up at 6 weeks, 6, 12 and 24 months. The primary analysis will use an intention to treat (ITT) approach and multiple imputation for missing data. The sample size was calculated to detect a 15 % greater improvement in the BTCQ overall score in the injection group compared to night-splinting at approximately 90 % power, 5 % two-tailed significance and allows for 15 % loss to follow-up. DISCUSSION: The trial makes an important contribution to the evidence base available to support effective conservative management of CTS in primary care. No previous trials have directly compared these treatments for CTS in primary care populations, reported on clinical effectiveness at more than 6 months nor compared cost effectiveness of the interventions. TRIAL REGISTRATION: Trial registration: EudraCT 2013-001435-48 (registered 05/06/2013), ClinicalTrials.gov NCT02038452 (registered 16/1/2014), and Current Controlled Trials ISRCTN09392969 (retrospectively registered 01/05/2014).

Healthcare Costs and Resource Utilization in Patients with Multiple Sclerosis Relapses Treated with H.P. Acthar Gel(®).

INTRODUCTION: Multiple sclerosis (MS) is an autoimmune disorder with large annual costs. This study evaluated utilization and costs for the management of MS relapses with H.P. Acthar(®) Gel (repository corticotropin injection; Acthar; Mallinckrodt) compared to receipt of plasmapheresis (PMP) or intravenous immunoglobulin (IVIG) among patients with MS who experienced multiple relapses. METHODS: We identified patients with MS diagnoses who had relapses treated with intravenous methylprednisolone (IVMP), the first-line treatment for MS relapse. Patients who were treated for the subsequent relapses were eligible for the study. We analyzed 12- and 24-month healthcare utilization and costs among patients who received Acthar prescriptions compared to patients who were treated with PMP/IVIG using generalized linear and logistic regression models to calculate unadjusted and adjusted means and 95% confidence intervals. RESULTS: For the 12-month analysis, a total of 213 patients received Acthar prescriptions and 226 were treated with PMP or IVIG. Patients who received Acthar prescriptions were similar to those who received other treatments in terms of most demographic variables. Acthar recipients had fewer hospitalizations (0.2 vs. 0.4; P = 0.01) and received fewer outpatient services (29 vs. 43; P < 0.0001) but received more prescription medications (36 vs. 30; P < 0.0001) compared to recipients of PMP/IVIG. Patients who received Acthar prescriptions had lower inpatient and outpatient costs ($15,000 lower; P = 0.001; and $54,000 lower; P < 0.0001, respectively) but similar total costs. Similar results were seen in the cohort with 24 months of outcome data. CONCLUSION: Acthar may be a useful treatment option compared to PMP/IVIG for patients with MS experiencing multiple relapses. FUNDING: This study was funded by a grant to the University of Washington from Mallinckrodt Pharmaceuticals.

Subacromial impingement syndrome and pain: protocol for a randomised controlled trial of exercise and corticosteroid injection (the SUPPORT trial).

BACKGROUND: Subacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults. Management commonly includes exercise and corticosteroid injection. However, the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small, of poor quality, and focus only on short-term results. Exercise packages tend to be standardised rather than individualised and progressed. There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections. However, there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome. This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise (standardised advice and information leaflet versus physiotherapist-led exercise) and from subacromial corticosteroid injection (blind versus ultrasound-guided), and provide long-term follow-up data on clinical and cost-effectiveness. METHODS/DESIGN: The study design is a 2x2 factorial randomised controlled trial. 252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire, UK. Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups: (1) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme, (2) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet, (3) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme, or (4) blind subacromial corticosteroid injection and an advice and exercise leaflet. The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index (SPADI) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions. Although independence of treatment effects is assumed, the magnitude of any interaction effect will be examined (but is not intended for the main analyses). Secondary outcomes will include comparison of long-term outcomes (12 months) and cost-effectiveness. A secondary per protocol analysis will also be performed. DISCUSSION: This protocol paper presents detail of the rationale, design, methods and operational aspects of the SUPPORT trial. TRIAL REGISTRATION: Current controlled trials ISRCTN42399123.

Outcomes in treatment of infantile spasms with pulse methylprednisolone.

The authors report their experience with intravenous methylprednisolone for the treatment of infantile spasms. A pulse dose of 20 mg/kg intravenous methylprednisolone on each of 3 successive days, followed by a 2-month oral prednisolone taper, led to the rapid remission (range, 2-6 days) of infantile spasms in 5 of 10 (50%) infants. In the subgroup of infants treated within 1 month of onset, 5 of 6 (83%) experienced remission within 6 days. The authors estimate the medication cost of intravenous methylprednisolone with prednisolone taper to be less than $200. In comparison, the cost of a typical course of adrenocorticotropic hormone in the United States can exceed $70,000. Initial treatment with intravenous methylprednisolone and/or oral corticosteroids is a reasonable cost-effective approach to infantile spasms. The lack of serious side effects, low cost, availability, ease of administration, and comparable efficacy suggests that intravenous methylprednisolone merits consideration for study in randomized prospective trials.

Home administration of intravenous methylprednisolone for multiple sclerosis relapses: the experience of French multiple sclerosis networks.

BACKGROUND: One single center study has provided support for a home-based approach to the therapeutic management of multiple sclerosis (MS) relapse. OBJECTIVE: To report a multicenter series of patients with MS who were treated at home for a relapse with a 3-day course of intravenous methylprednisolone. METHODS: The home administration of intravenous methylprednisolone was coordinated by four MS networks in France; patients with MS with a relapse were referred by their neurologists, and treatment was administered by a local nurse. We analyzed the safety and efficiency of this approach and estimated the related cost savings. Patients completed a patient satisfaction questionnaire. RESULTS: Eight hundred and seven patients received intravenous methylprednisolone at home. The mean disease duration was 10.3 +/- 7.9 years. Treatment was often prescribed by community-based neurologists. The delay between prescription and treatment was 2.8 +/- 0.5 days if treatment was initiated at home and 1.9 +/- 3.0 days if treatment was initiated in hospital (the subsequent two injections were always administered at home). Home treatment was well tolerated; three serious side effects requiring hospital transfer were observed (anxiety, thoracic oppression, and arrhythmia), which were fully reversible. Overall, 93.8% of patients were satisfied with the treatment approach, and 98% wished to receive future treatment courses at home. The overall cost savings of home-based treatment versus hospital-based treatment were evaluated at EUR1,091,482. CONCLUSION: Safety data, patient satisfaction, and economic considerations support home-based treatment of MS relapses with intravenous methylprednisolone, provided strict patient selection criteria are observed and the process is coordinated and closely monitored by an MS network.

Intermediate dose gemcitabine-cisplatin combination chemotherapy without treatment delay for cytopenia followed by autografting--a new standard of care in relapsed or refractory Hodgkin lymphoma?

Ten percent to 20% of patients with Hodgkin Lymphoma (HL) are refractory to first-line therapy or relapse. Existing salvage regimens have response rates of 60-85%, considerable toxicity and frequent treatment delay or dose reduction. We report a gemcitabine, cisplatin, and dexamethasone regimen (GemCis) with intensive growth factor and platelet support and no treatment delay. Seventeen patients with relapsed or refractory biopsy proven HL were treated. Toxicity, transfusion requirement, stem cell harvesting and engraftment data were collected. Response assessment was by computed tomography and positron emission tomography. Overall and complete response rates were high (94% and 65%, respectively). There were no episodes of febrile neutropenia, treatment delays or hospital admissions. All 15 patients intended for autograft were successfully harvested. All engrafted successfully with a median time for the entire group to neutrophil engraftment of 14 days. With a median follow-up of 22 months, the median survival has not yet been reached, and the estimated 2-year survival is 88%. GemCis is a well-tolerated outpatient regimen for relapsed/ refractory Hodgkin lymphoma which does not inhibit stem cell mobilisation, gives excellent response rates and compares favourably with previously published salvage regimens using these or other chemotherapy agents.

Cost analysis of therapy for patients with multiple sclerosis (MS) in Poland.

Multiple sclerosis (MS) is a neurological disease of the central nervous system in which dissipated demyelination lesions develop. The currently available pharmacotherapy and rehabilitation for this disease aims to preserve the patients' physical abilities and prevent disease progression and nervous system damage. The study evaluated the direct and indirect costs associated with two different treatment regimens for multiple sclerosis diagnosed patients by comparing two groups of 60 subjects (Group A--patients receiving continuous interferon therapy (Betaferon) and steroids during relapses, and Group B--patients receiving steroid-only (Solu-Medrol, Metypred) treatment). The study was conducted over two years (2004-2005). The pharmacotherapy costs for MS patients were: PLN 4,555,360.68 (1,171,043.88euro) total for Group A and PLN 75,922.68 (19,517.40euro) per patient, and PLN 72,582.00 (18,658.61euro) total for Group B and PLN 1,209.70 (310.98euro) per patient. Total direct and indirect costs for Group A and Group B amounted to PLN 5,595,968.58 (1,438,552.33euro) and PLN 1,655,658.30 (425,619.10euro), respectively.

Efficacy and safety of methylprednisolone aceponate ointment 0.1% compared to tacrolimus 0.03% in children and adolescents with an acute flare of severe atopic dermatitis.

BACKGROUND: Topical glucocorticosteroids are the gold standard in treatment of atopic dermatitis (AD). Recently, topical calcineurin inhibitors have been developed for treatment of this condition. This study compared efficacy and safety of 0.1% methylprednisolone aceponate (MPA) ointment with 0.03% tacrolimus ointment for 3 weeks, in children and adolescents with severe to very severe flare of AD. METHODS: The primary end point was treatment success, defined as a score of 'clear' or 'almost clear' in the static Investigator's Global Assessment (IGA) score. Secondary end points were the percentage change in the Eczema Area and Severity Index (EASI) and patients' assessment of itch and sleep, Children's Dermatology Life Quality Index, patient's assessment of global response, affected Body Surface Area and medication costs. RESULTS: 265 patients were randomized to either MPA (n = 129) or tacrolimus (n = 136) treatment, 257 patients completed the study. Methylprednisolone aceponate 0.1% ointment once daily provided rapid and relevant clinical benefit. Tacrolimus 0.03% ointment twice daily was equally effective with regard to success rate. Methylprednisolone aceponate was superior to tacrolimus for EASI, itch and sleep. Both treatments were well tolerated. Drug-related adverse events were only observed in the tacrolimus group. Medication costs were significantly lower for MPA. CONCLUSIONS: While both treatment groups showed similar efficacy results regarding treatment success (IGA), significant advantages were observed for EASI, itch and sleep with MPA 0.1%. These advantages and the significantly lower treatment costs highlight the benefits of MPA treatment, underlining its first-line role in treatment of children and adolescents with severe AD.

A cost-utility analysis of treatment for acute childhood idiopathic thrombocytopenic purpura (ITP).

BACKGROUND: The primary objective in the treatment of acute pediatric idiopathic thrombocytopenic purpura (ITP) is to rapidly increase the platelet count. METHODS: We built a decision analytic model to evaluate the cost-utility of four commonly used treatment strategies: intravenous immunoglobulin G (IVIG) 0.8 g/kg, anti-D 75 mcg/kg, methylprednisolone (30 mg/kg for 3 days), and prednisone (4 mg/kg/day for 4 days). In our baseline model, all children were hospitalized upon presentation, and discharged once the platelet count reached > or =20,000. We performed a literature search to estimate time to platelet count > or =20,000 for each strategy, as well as the probability of side effects. We obtained cost data and quality of life measures from institutional and published data sources. RESULTS: Total cost of one-time treatment for a 20 kg child was US dollars 786 with prednisone, US dollars 1,346 with methylprednisolone, US dollars 2,035 with anti-D, and US dollars 2,492 with IVIG. The strategies of IVIG and methylprednisolone were less effective and more expensive than anti-D and prednisone, respectively. Although anti-D caused the most rapid rise in platelet counts, the incremental cost-utility ratio (costs incurred by using anti-D instead of prednisone divided by health benefit of using anti-D instead of prednisone) was US dollars 7,616 per day of severe thrombocytopenia avoided, primarily due to the much higher medication cost of anti-D. Utilizing an outpatient model, the cost difference between anti-D and prednisone was even more striking. CONCLUSIONS: The clinical benefit of anti-D is offset by a substantial cost increase. Although often overlooked in favor of newer agents, a brief course of high-dose prednisone is an inexpensive and effective treatment for acute ITP.

Computerized reminders reduce the use of medications during shortages.

Medication shortages pose serious problems in health care. This study examines the impact of a computer-based reminder in addressing a national methylprednisolone shortage. An alert was designed and implemented in a computerized order entry platform at a children's hospital. The alert informed physicians of the shortage and provided an alternative prescribing pathway. Data regarding the number and type of parenteral corticosteroid prescriptions were collected for a one-month period before and after the alert was implemented. The alert resulted in a 55% relative reduction in methylprednisolone use and an average reduction of more than three orders each day. Dexamethasone and hydrocortisone, the recommended alternative medications, increased in use by 12% and 49%, respectively. The alert resulted in a $36,552 annualized cost reduction to the institution. Similar alert applications have great potential for effectively altering physician prescribing behavior.

Cost of managing an episode of relapse in multiple sclerosis in the United States.

BACKGROUND: The purpose of this study was to determine the direct medical US cost of managing multiple sclerosis relapses. METHODS: Direct data analysis and cost modeling were employed to derive typical resource use profiles and costs in 2002 US dollars, from the perspective of a third-party payer responsible for comprehensive health-care. The location and scope of health care services provided over a 90-day period were used to define three levels of relapse management. Hospitalization and resulting subsequent care was defined as high intensity management. A medium level of intervention was defined as either use of the emergency room, an observational unit, or administration of acute treatments, such as intravenous methylprednisolone in an outpatient or home setting. The lowest intensity of care comprised physician office visits and symptom-related medications. Data were obtained from many sources including all payer inpatient, ambulatory and emergency room databases from several states, fee schedules, government reports, and literature. All charges were adjusted using cost-to-charge ratios. RESULTS: Average cost per person for high management level was 12,870 dollars, based on analysis of 4,634 hospital cases (mean age 48 years, 73% female). Hospital care comprised 71% of that cost. At discharge, 36% required inpatient sub-acute care, rehabilitation or home care. The typical cost per moderate episode was 1,847 dollars and mild episode 243 dollars. CONCLUSIONS: Management strategies leading to a reduction in the frequency and severity of a relapse, less reliance on inpatient care, or increased access to steroid infusions in the home, would have a substantial impact on the economic consequences of managing relapses.

Corticosteroid prescription filling for children covered by Medicaid following an emergency department visit or a hospitalization for asthma.

OBJECTIVE: To identify predictors of corticosteroid prescription filling following an emergency department (ED) visit or a hospitalization for asthma. DESIGN: A retrospective cohort study. PATIENTS: Tennessee children (defined as those aged 2-17 years in this study) covered by Medicaid were included in the cohort if they had an ED visit or a hospitalization for asthma between July 1, 1995, and December 31, 1997. MAIN OUTCOME MEASURES: Prescriptions filled in the child's name for an oral corticosteroid within 7 days of the latest ED visit or hospitalization for asthma. RESULTS: Of 6035 Tennessee children covered by Medicaid with an ED visit for asthma and of 2102 covered by Medicaid with a hospitalization for asthma during the study period, less than half (44.8% following an ED visit and 55.5% following a hospitalization) had prescriptions filled for oral corticosteroids within 7 days. Factors independently predicting a child's not having an oral corticosteroid prescription filled included older age, black race, and residence in rural regions of the state. Conversely, children with oral corticosteroid prescriptions in the previous 6 months were more likely to have oral corticosteroid prescriptions filled following an ED visit for asthma, and children with more than 3 beta-agonist prescriptions in the previous 6 months were more likely to have oral corticosteroid prescriptions filled following a hospitalization for asthma. CONCLUSIONS: Overall, fewer than half of Tennessee children covered by Medicaid had an oral corticosteroid prescription filled following an ED visit or a hospitalization for asthma. Age, race, and county of residence predicted failure to have a prescription filled. Further study is needed to determine whether variations in corticosteroid prescription filling relate to physician practice, family behavior, or both.

Periradicular infiltration for sciatica: a randomized controlled trial.

STUDY DESIGN: A randomized, double-blind trial was conducted. OBJECTIVES: To test the efficacy of periradicular corticosteroid injection for sciatica. SUMMARY OF BACKGROUND DATA: The efficacy of epidural corticosteroids for sciatica is controversial. Periradicular infiltration is a targeted technique, but there are no randomized controlled trials of its efficacy. METHODS: In this study 160 consecutive, eligible patients with sciatica who had unilateral symptoms of 1 to 6 months duration, and who never underwent surgery were randomized for double-blind injection with methylprednisolone bupivacaine combination or saline. Objective and self-reported outcome parameters and costs were recorded at baseline, at 2 and 4 weeks, at 3 and 6 months, and at 1 year. RESULTS: Recovery was better in the steroid group at 2 weeks for leg pain (P = 0.02), straight leg raising (P = 0.03), lumbar flexion (P = 0.05), and patient satisfaction (P = 0.03). Back pain was significantly lower in the saline group at 3 and 6 months (P = 0.03 and 0.002, respectively), and leg pain at 6 months (13.5, P = 0.02). Sick leaves and medical costs were similar for both treatments, except for cost of therapy visits and drugs at 4 weeks, which were in favor of the steroid injection (P = 0.05 and 0.005, respectively). By 1 year, 18 patients in the steroid group and 15 in the saline group underwent surgery. CONCLUSIONS: Improvement during the follow-up period was found in both the methylprednisolone and saline groups. The combination of methylprednisolone and bupivacaine seems to have a short-term effect, but at 3 and 6 months, the steroid group seems to experience a "rebound" phenomenon.

Cost analysis of methylprednisolone treatment of multiple sclerosis patients.

BACKGROUND: Intravenous methylprednisolone (IVMP) is the treatment of choice for multiple sclerosis (MS) patients undergoing acute exacerbation of disease symptoms and yet its cost has not been accurately determined. Determination of this cost in different settings is also pertinent to consideration of cost-saving alternatives to in-patient treatment. METHODS: Cost analysis from the point of view of the health care system of IVMP treatment of MS patients receiving treatment in association with a selected Toronto teaching hospital in fiscal year 1994/95 was carried out. Costs of any concurrent treatments were excluded. RESULTS: Total cost for 92 patients, based on a 4 dose regime, was estimated to be $78,527. The the cost per patient was $1,1181.84 for in-patients (IP), $714.64 for out-patients of the MS Clinic (OP) and $774.21 for patients whose treatment was initiated in the Clinic, but completed in the home (HC). Sensitivity analyses indicated: 1) IP treatment was in all cases more expensive than that of OP or HC; 2) the cost savings of OP vs. HC was sensitive to assumptions made regarding Clinic overhead, Clinic nursing costs and Home Care Program overhead. CONCLUSION: Alternatives to in-patient care must be considered carefully. In this study, both out-patient and in-home treatment were cost-saving alternatives to in-patient treatment, but large differences in the cost of hospital out-patient vs. in-home care could not be demonstrated.

Double-blind, randomized, placebo-controlled study of oral, high-dose methylprednisolone in attacks of MS.

OBJECTIVE: There is only limited evidence from adequately controlled clinical trials to support high-dose methylprednisolone therapy for attacks of multiple sclerosis (MS) and none supporting oral administration. We assessed the effect of oral high-dose methylprednisolone therapy in attacks of MS. METHODS: Twenty-five patients with an attack of MS lasting less than 4 weeks were randomized to placebo treatment. Twenty-six patients received oral methylprednisolone (500 mg once a day for 5 days with a 10-day tapering period). The patients received scores on the Scripps Neurological Rating Scale (NRS) and Kurtzke Expanded Disability Status Scale. The symptoms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks of treatment. Primary efficacy measures were NRS and VAS scores in the first 3 weeks and changes in NRS score and answers to an efficacy questionnaire administered after 8 weeks of treatment. RESULTS: Changes in NRS scores among methylprednisolone- and placebo-treated patients differed significantly in the first 3 weeks and after 8 weeks (p = 0.005 and p = 0.0007). VAS scores the first 3 weeks and treatment efficacy after 8 weeks also favored a beneficial effect of methylprednisolone treatment (p = 0.02 and p = 0.05). After 1, 3, and 8 weeks, 4%, 24%, and 32% in the placebo group and 31%, 54%, and 65% in the methylprednisolone group had improved one point on the Expanded Disability Status Scale score (all p < 0.05). No serious adverse events were seen. CONCLUSION: Oral high-dose methylprednisolone is recommended for managing attacks of MS.