Patients with multiple sclerosis choose a collaborative role in making treatment decision: results from the Italian multicenter SWITCH study.

BACKGROUND: Clinicians are increasingly recognizing the importance of shared decision-making in complex treatment choices, highlighting the importance of the patient's rationale and motivation for switching therapies. This study aimed to evaluate the association between different modalities of changing multiple sclerosis (MS) treatments, cognitive profile and attitude and preferences of patients concerning treatment choice. METHODS: This multicenter cross-sectional study was conducted at 28 Italian MS centers in the period between June 2016 and June 2017. We screened all MS patients treated with any DMT, with a treatment compliance of at least 80% of therapy administered during the 3 last months who needed to modify MS therapy because of efficacy, safety or other reasons during a follow-up visit. At the time of switching the symbol digit modalities test (SDMT) and the Control Preference Scale (CPS) were evaluated. According to the CPS, patients were classified as "active" (i.e. who prefer making the medical decision themselves), "collaborative" (i.e. who prefer decisions be made jointly with the physician), or "passive" (i.e. who prefer the physician make the decision). RESULTS: Out of 13,657 patients recorded in the log, 409 (3%) changed therapy. Of these, 336 (2.5%) patients, 69.6% were female and with mean age 40.6 ± 10.5 years, were enrolled. According to the CPS score evaluation, a significant high percentage of patients (51.1%) were considered collaborative, 74 patients (22.5%) were passive, and 60 (18.2%) patients were active. Stratifying according to CPS results, we found a higher SDMT score among collaborative patients compared to active and passive ones (45.8 ± 12.3 versus 41.0 ± 13.2 versus 41.7 ± 12.8, p < 0.05). CONCLUSION: In this study, the CPS evaluation showed that more than 50% of patients who needed to change therapy chose a "collaborative" role in making treatment decision. Cognitive profile with SDMT seems to correlate with patients' preference on treatment decision, showing better scores in collaborative patients.

Antimuscarinics for neurogenic overactive bladder in multiple sclerosis: real-life data.

Background: Antimuscarinics (AMs) represent the mainstay of treatment for storage lower urinary tract symptoms (LUTS) but few data are available on their impact in multiple sclerosis (MS) patients. Objective: To assess effectiveness and tolerability of AMs in MS patients with neurogenic detrusor overactivity (NDO). Methods: Sixty consecutive outpatients, who started treatment with AMs at one centre, were recruited. The primary endpoint was change in Patient's Perception of Intensity of Urgency Scale (PPIUS) at 6 months; secondary endpoints were post-void residual urine (PVR) and pads used daily. Incidence and severity of adverse events (AEs) were recorded. Results: Significant reduction (p < 0.001) of mean PPIUS and pads use were detected, as well as a significant increase (p < 0.001) of PVR (143 ±â€„42 ml).AEs, recorded in 53% of patients, were frequently multiple and caused suspension of AM in 10% of cases, mainly for xerostomia, which has been the commonest AE (26.6%). Neurological AEs appeared in 11.7% of subjects, mostly with oxybutynin. Worsening/onset of voiding LUTS, reported by 8.3% of MS, resulted to be the unique AE correlated to AM dosage. Conclusion: This study suggests that AMs are effective in MS patients, but their use should be tailored on every patient as even low dosages can be poorly tolerated. AEs, including neurological ones, are common.

A survey of clinical practice concerning long-term follow-up of neurogenic lower urinary tract dysfunction due to spinal cord injury in Italy.

CONTEXT/OBJECTIVE: This study aimed to assess the clinical practice for long-term follow-up (FU) of neurogenic lower urinary tract dysfunction (NLUTD) due to spinal cord injury (SCI) in Italy and compare this practice with the clinical practice in other countries and with the international guidelines. DESIGN: Data concerning the long-term urological FU of individuals with SCI were collected using a questionnaire and analyzed by means of descriptive and inferential statistics. SETTING: Twenty-one Italian centers following SCI patients. PARTICIPANTS: One physician at each center (either a permanent staff member or chief). OUTCOME MEASURES: Questions addressed the treatment of urinary tract infections (UTI), frequency of visits, urinary tract imaging examinations and urodynamic tests (UD), distinguishing between suprasacral and sacral SCI. RESULTS: Nineteen out of 21 centers completed the survey. In most centers, patients were recommended to undergo a visit and an ultrasound examination of urinary tract (UT) at least once a year. While the median interval between FU visits was identical (12 months) for individuals with suprasacral and sacral SCI, the two interval distributions were significantly different (suprasacral SCI: min-max 4-18, IQR = 6; sacral SCI: min-max 6-24; IQR = 8.5; P = 0.02), showing people with suprasacral SCI are followed up more often. Approximately 80% of the surveyed centers performed scheduled UD, with a yearly median frequency of 12 months (range 6-36) for patients with suprasacral SCI, as compared to a median frequency of 18 months for sacral SCI (range 0-36, P = 0.04). VideoUD and antibiotic prophylaxis for recurrent UTIs are carried out only by urologists in 63% and 47.4% of the centers, respectively. Overall, Italian centers share common strategies that compare to standards, including yearly visits, yearly UT examinations and stricter follow-up of people with suprasacral SCI, but may not have standard protocols for antibiotic prophylaxis of UTI, and in few cases control visits and UD are carried out too often. CONCLUSIONS: Even though most Italian centers follow up patients with NLUTD secondary to SCI according to international guidelines, heterogeneity in frequency of FU examinations still exists. A tailored approach to the SCI patient that minimizes unnecessary examinations and groups different tests in a single access could improve patients' compliance with FU and reduce costs for the Health system.

Plant Foods Rich in Antioxidants and Human Cognition: A Systematic Review.

Oxidative stress can compromise central nervous system integrity, thereby affecting cognitive ability. Consumption of plant foods rich in antioxidants could thereby protect cognition. We systematically reviewed the literature exploring the effects of antioxidant-rich plant foods on cognition. Thirty-one studies were included: 21 intervention, 4 cross-sectional (one with a cohort in prospective observation as well), and 6 prospective studies. Subjects belonged to various age classes (young, adult, and elderly). Some subjects examined were healthy, some had mild cognitive impairment (MCI), and some others were demented. Despite the different plant foods and the cognitive assessments used, the results can be summarized as follows: 7 studies reported a significant improvement in all cognitive domains examined; 19 found significant improvements only in some cognitive areas, or only for some food subsets; and 5 showed no significant improvement or no effectiveness. The impact of dietary plant antioxidants on cognition appears promising: most of the examined studies showed associations with significant beneficial effects on cognitive functions-in some cases global or only in some specific domains. There was typically an acute, preventive, or therapeutic effect in young, adult, and elderly people, whether they were healthy, demented, or affected by MCI. Their effects, however, are not attributable only to anti-oxidation.

Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study.

OBJECTIVE: To identify baseline factors associated with disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) under teriflunomide treatment. METHODS: This was an independent, multi-centre, retrospective post-marketing study. We analysed data of 1,507 patients who started teriflunomide since October 2014 and were regularly followed in 28 Centres in Italy. We reported the proportions of patients who discontinued treatment (after excluding 32 lost to follow-up) and who experienced clinical disease activity, i.e., relapse(s) and/or confirmed disability worsening, as assessed by the Expanded Disability Status Scale (EDSS). Decision tree-based analysis was performed to identify baseline factors associated with clinical disease activity during teriflunomide treatment. RESULTS: At database lock (September 2020), approximately 29% of patients (430 out of 1,475) discontinued teriflunomide because of disease activity (~ 46%), adverse events (~ 37%), poor tolerability (~ 15%), pregnancy planning (~ 2%). Approximately 28% of patients experienced disease activity over a median follow-up of 2.75 years: ~ 9% had relapses but not disability worsening; ~ 13% had isolated disability worsening; ~ 6% had both relapses and disability worsening. The most important baseline factor associated with disease activity (especially disability worsening) was an EDSS > 4.0 (p < 0.001). In patients with moderate disability level (EDSS 2.0-4.0), disease activity occurred more frequently in case of ≥ 1 pre-treatment relapses (p = 0.025). In patients with milder disability level (EDSS < 2.0), disease activity occurred more frequently after previous exposure to ≥ 2 disease-modifying treatments (p = 0.007). CONCLUSIONS: Our study suggests a place-in-therapy for teriflunomide in naïve patients with mild disability level or in those who switched their initial treatment for poor tolerability. Adverse events related with teriflunomide were consistent with literature data, without any new safety concern.

Clinical and patient determinants of changing therapy in relapsing-remitting multiple sclerosis (SWITCH study).

BACKGROUND: clinical factors and frequency of disease-modifying therapy (DMT) changes/interruptions in relapsing-remitting multiple sclerosis (RRMS) patients have not been well defined. The aim of this study was to describe reasons of MS treatment modifications in a large cohort of Italian MS patients. METHODS: this multicenter, cross-sectional non interventional study (SWITCH) conducted at 28 Italian MS centers, screened, by visit/telephone contact between June 2016 and June 2017, all RRMS patients receiving stable DMT treatment and enrolled patients with change in DMT treatment. RESULTS: out of 13,657 recorded in the log, 409 (3%) changed therapy. Of these, 336 (2.5%), met the study criteria and were considered eligible. Among 303 (90.2% of 336) patients switching, the most common reason was "lack of efficacy" (58.4% of 303). Among 30 (8.9%) patients who interrupted treatment temporarily, the most common reason was pregnancy (40.0% of 30). Out of 3 (0.9%) patients who discontinued treatment permanently, 2 (66.7%) had as first reason as "patient decision". Multivariate analysis showed that EDSS was the only variable with statistically significant effect on changing treatments (r = 8.33; p-value of Type III Sum of Squares = 0.016). CONCLUSION: in our study, 303 (90.2% of eligible patients) switched treatment, 30 (8.9%) interrupted treatment temporarily, and 3 (0.9%) discontinued treatment permanently. Efficacy remains the main driving force behind switching behavior, as the primary aim of treatment is to be disease free or reduce disease activity.

Usefulness of sacral nerve modulation in a series of multiple sclerosis patients with bladder dysfunction.

OBJECTIVE: Bladder dysfunctions are common in multiple sclerosis (MS) often causing the most distressing symptoms. The aim of this paper was to evaluate the effectiveness of sacral nerve modulation (SNM) in this disease. METHODS: We conducted an observational retrospective survey in 17 patients treated with SNM in the north-east of Italy, all complaining of bladder symptoms (storage in 41%, voiding in 24%, mixed in 35%) unresponsive to conventional therapies, with a mean follow-up of 52 ± 26 months and mean Expanded Disability Status Scale score of 5.8 ± 1.8. RESULTS: 75% of patients reported significant and lasting improvement in bladder symptoms and in quality of life. We observed a statistically significant improvement in frequency, urgency, number of pads, residual volumes, number of catheterizations and in the voided volumes. In 5 out of 6 cases with mixed symptoms the stimulation was discontinued (device totally explanted or turned off) after a mean time of 66 months (range 10-84 months) after the implant, for disease progression or loss of efficacy. CONCLUSION: SNM could be an option in very selected cases of storage and voiding symptoms refractory to conservative treatments caused by a stable or slowly progressive MS considering its minimal invasiveness and reversibility. The poor results observed suggest avoiding this therapy in mixed symptoms and in cases of advanced disability.

Multicenter case-control study on restless legs syndrome in multiple sclerosis: the REMS study.

STUDY OBJECTIVES: To verify the existence of a symptomatic form of restless legs syndrome (RLS) secondary to multiple sclerosis (MS) and to identify possible associated risk factors. DESIGN: Prospective, multicenter, case-control epidemiologic survey. SETTINGS: Twenty sleep centers certified by the Italian Association of Sleep Medicine. PATIENTS: Eight hundred and sixty-one patients affected by MS and 649 control subjects. INTERVENTIONS: N/A. MEASURES AND RESULTS: Data regarding demographic and clinical factors, presence and severity of RLS, the results of hematologic tests, and visual analysis of cerebrospinal magnetic resonance imaging studies were collected. The prevalence of RLS was 19% in MS and 4.2% in control subjects, with a risk to be affected by RLS of 5.4 (95%confidence interval: 3.56-8.26) times greater for patients with MS than for control subjects. In patients with MS, the following risk factors for RLS were significant: older age; longer MS duration; the primary progressive MS form; higher global, pyramidal, and sensory disability; and the presence of leg jerks before sleep onset. Patients with MS and RLS more often had sleep complaints and a higher intake of hypnotic medications than patients with MS without RLS. RLS associated with MS was more severe than that of control subjects. CONCLUSIONS: RLS is significantly associated with MS, especially in patients with severe pyramidal and sensory disability. These results strengthen the idea that the inflammatory damage correlated with MS may induce a secondary form of RLS. As it does in idiopathic cases, RLS has a significant impact on sleep quality in patients with MS; therefore, it should be always searched for, particularly in the presence of insomnia unresponsive to treatment with common hypnotic drugs.