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BACKGROUND: The treatment landscape for neuromyelitis optica spectrum disorder (NMOSD) has changed in recent years with the approval of therapies with different efficacy, safety and administration profiles. OBJECTIVE: The aim of this study was to assess neurologists' preferences for different NMOSD treatment attributes using conjoint analysis (CA). METHODS: We conducted an online, non-interventional, cross-sectional study in collaboration with the Spanish Society of Neurology. Our CA assessed five drugs' attributes: prevention of relapse, prevention of disability accumulation, safety risk, management during pregnancy, and route and frequency of administration. Participants were presented with eight hypothetical treatment scenarios to rank based on their preferences from the most preferred to the least. An ordinary least squares method was selected to estimate weighted preferences. RESULTS: A total of 104 neurologists were included. Mean age (standard deviation-SD) was 37.7 (10.3) years, 52.9 % were male, and median time (interquartile range) of experience managing NMOSD was 5.0 (2.9, 10.8) years. Neurologists placed the greatest importance on efficacy attributes, time to relapse (44.1 %) being the most important, followed by preventing disability accumulation (36.8 %). In contrast, route and frequency of administration (4.6 %) was the least important characteristic. Participants who prioritised efficacy attributes felt more comfortable in decision-making, had fewer past experiences of care-related regret and a lower attitude to risk taking than their counterparts. CONCLUSION: Neurologists' treatment preferences in NMOSD were mainly driven by efficacy attributes. These results may be useful to design policy decisions and treatment guidelines for this condition.
Subject(s)
Neurologists , Neuromyelitis Optica , Humans , Neuromyelitis Optica/therapy , Neuromyelitis Optica/drug therapy , Female , Adult , Spain , Cross-Sectional Studies , Male , Middle Aged , Attitude of Health Personnel , Practice Patterns, Physicians'/statistics & numerical dataABSTRACT
Purpose: Shared decision-making is critical in multiple sclerosis (MS) due to the uncertainty of the disease trajectory over time and the large number of treatment options with differing efficacy, safety and administration characteristics. The aim of this study was to assess patients' decisional conflict regarding the choice of a disease-modifying therapy and its associated factors in patients with mid-stage relapsing-remitting multiple sclerosis (RRMS). Methods: A multicenter, non-interventional study was conducted. Adult patients with a diagnosis of RRMS (2017 revised McDonald criteria) and disease duration of 3 to 8 years were included. The level of uncertainty experienced by a patient when faced with making a treatment choice was assessed using the 4-item Decisional Conflict Scale. A battery of patient-reported and clinician-rated measures was administered to obtain information on symptom severity, illness perception, illness-related uncertainty, regret, MS knowledge, risk taking behavior, preferred role in the decision-making process, cognition, and self-management. Patients were recruited during routine follow-up visits and completed all questionnaires online using electronic tablets at the hospital. A multivariate logistic regression analysis was conducted. Results: A total of 201 patients were studied. Mean age (Standard deviation) was 38.7 (8.4) years and 74.1% were female. Median disease duration (Interquartile range) was 6.0 (4.0-7.0) years. Median EDSS score was 1.0 (0-2.0). Sixty-seven (33.3%) patients reported a decisional conflict. These patients had lower MS knowledge and more illness uncertainty, anxiety, depressive symptoms, fatigue, subjective symptom severity, a threatening illness perception, and poorer quality of life than their counterparts. Lack of decisional conflict was associated with MS knowledge (Odds ratio [OR]=1.195, 95% CI 1.045, 1.383, p=0.013), self-management (OR=1.049, 95% CI 1.013, 1.093, p=0.018), and regret after a healthcare decision (OR=0.860, 95% CI 0.756, 0.973, p=0.018) in the multivariate analysis. Conclusion: Decisional conflict regarding the selection of a disease-modifying therapy was a common phenomenon in patients with mid-stage RRMS. Identifying factors associated with decisional conflict may be useful to implement preventive strategies that help patients better understand their condition and strengthen their self-management resources.
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A multicenter study involving 204 adults with relapsing-remitting multiple sclerosis (RRMS) assessed the dimensionality and item characteristics of the Mishel-Uncertainty of Illness Scale (MUIS), a generic self-assessment tool. Mokken analysis identified two dimensions in the MUIS with an appropriate item and overall scale scalability after excluding nonclassifiable items. A refined 12-item MUIS, employing a grade response model, effectively discriminated uncertainty levels among RRMS patients (likelihood ratio test p-value = .03). These findings suggest the potential value of the 12-item MUIS as a reliable measure for assessing uncertainty associated with the course of illness in RRMS.
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Introduction and objective: Limited information is available on how neurologists make therapeutic decisions in neuromyelitis optica spectrum disorder (NMOSD), especially when new treatments with different mechanisms of action, administration, and safety profile are being approved. Decision-making can be complex under this uncertainty and may lead to therapeutic inertia (TI), which refers to lack of treatment initiation or intensification when therapeutic goals are not met. The study aim was to assess neurologists' TI in NMOSD. Methods: An online, cross-sectional study was conducted in collaboration with the Spanish Society of Neurology. Neurologists answered a survey composed of demographic characteristics, professional background, and behavioral traits. TI was defined as the lack of initiation or intensification with high-efficacy treatments when there is evidence of disease activity and was assessed through five NMOSD aquaporin-4 positive (AQP4+) simulated case scenarios. A multivariate logistic regression analysis was used to determine the association between neurologists' characteristics and TI. Results: A total of 78 neurologists were included (median interquartile range [IQR] age: 36.0 [29.0-46.0] years, 55.1% male, median [IQR] experience managing demyelinating conditions was 5.2 [3.0-11.1] years). The majority of participants were general neurologists (59.0%) attending a median (IQR) of 5.0 NMOSD patients (3.0-12.0) annually. Thirty participants (38.5%) were classified as having TI. Working in a low complexity hospital and giving high importance to patient's tolerability/safety when choosing a treatment were predictors of TI. Conclusion: TI is a common phenomenon among neurologists managing NMOSD AQP4+. Identifying TI and implementing specific intervention strategies may be critical to improving therapeutic decisions and patient care.
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INTRODUCTION: Natalizumab (NTZ) is an effective drug for the treatment of relapsing-remitting multiple sclerosis. In some patients discontinuation is mandatory due to the risk of progressive multifocal leukoencephalopathy. However, severe clinical and radiological worsening has been described after drug cessation. Our aim was to describe the clinical and radiological features of the rebound phenomenon. MATERIAL AND METHODS: Patients switched from NTZ to Fingolimod (FTY) who had presented a rebound after discontinuation were selected. Clinical and magnetic resonance imaging (MRI) data were collected. RESULTS: Four JC virus positive patients were included. The mean disease duration was 9.5 years (SD: 4.12) with a mean time of 3.1 years on NTZ. All patients started FTY within 3-4 months. Neurological deterioration started in a mean time of 3.5 months (SD: 2.08) with multifocal involvement: 75% motor disturbances, 50% cognitive impairment, 25% seizures. The average worsening in Expanded Disability Status Scale [EDSS] was of 3.25 points (SD: 2.33). The MRI showed a very large increase in T2 and gadolinium-enhanced lesions (mean: 23.67, SD: 18.58). All patients received 5 days of IV methylprednisolone, one patient required plasma exchange. All the patients presented neurological deterioration with an EDSS worsening of 1.13 points (SD: 0.48). After the rebound three patients continued treatment with FTY, only one patient restarted NTZ. CONCLUSION: Discontinuation of NTZ treatment may trigger a severe rebound with marked clinical and radiological worsening. A very careful evaluation of benefit-risk should be considered before NTZ withdrawal, and a close monitoring and a short washout period is recommended after drug withdrawal.
Subject(s)
Drug Substitution/adverse effects , Immunologic Factors/adverse effects , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/physiopathology , Natalizumab/adverse effects , Adult , Brain/diagnostic imaging , Cohort Studies , Disability Evaluation , Female , Fingolimod Hydrochloride/therapeutic use , Humans , Immunologic Factors/therapeutic use , Magnetic Resonance Imaging , Male , Multiple Sclerosis, Relapsing-Remitting/diagnostic imaging , Natalizumab/therapeutic use , Treatment FailureABSTRACT
Background Greater occipital nerve (GON) blocks are widely used for the treatment of headaches, but quality evidence regarding their efficacy is scarce. Objective The objective of this article is to assess the short-term clinical efficacy of GON anaesthetic blocks in chronic migraine (CM) and to analyse their effect on pressure pain thresholds (PPTs) in different territories. Participants and methods The study was designed as a double-blind, randomised, placebo-controlled clinical trial. Thirty-six women with CM were treated either with bilateral GON block with bupivacaine 0.5% ( n = 18) or a sham procedure with normal saline ( n = 18). Headache frequency was recorded a week after and before the procedure. PPT was measured in cephalic points (supraorbital, infraorbital and mental nerves) and extracephalic points (hand, leg) just before the injection (T0), one hour later (T1) and one week later (T2). Results Anaesthetic block was superior to placebo in reducing the number of days per week with moderate-or-severe headache (MANOVA; p = 0.027), or any headache ( p = 0.04). Overall, PPTs increased after anaesthetic block and decreased after placebo; after the intervention, PPT differences between baseline and T1/T2 among groups were statistically significant for the supraorbital (T0-T1, p = 0.022; T0-T2, p = 0.031) and infraorbital sites (T0-T1, p = 0.013; T0-T2, p = 0.005). Conclusions GON anaesthetic blocks appear to be effective in the short term in CM, as measured by a reduction in the number of days with moderate-to-severe headache or any headache during the week following injection. GON block is followed by an increase in PPTs in the trigeminal area, suggesting an effect on central sensitisation at the trigeminal nucleus caudalis. This trial is registered at ClinicalTrials.gov (NCT02188394).
Subject(s)
Anesthetics, Local/therapeutic use , Bupivacaine/therapeutic use , Migraine Disorders/drug therapy , Nerve Block/methods , Adult , Double-Blind Method , Female , Humans , Middle Aged , Young AdultABSTRACT
Background Presently, there is no evidence to guide the acute treatment of migraine aura. We aimed to describe the effect of greater occipital nerve (GON) anaesthetic block as a symptomatic treatment for long-lasting (prolonged or persistent) migraine aura. Methods Patients who presented with migraine aura lasting > 2 hours were consecutively recruited during one year at the Headache Unit and the Emergency Department of a tertiary hospital. All patients underwent a bilateral GON block with bupivacaine 0.5%. Patients were followed up for 24 hours. Results A total of 22 auras were treated in 18 patients. Auras consisted of visual ( n = 13), visual and sensory ( n = 4) or sensory symptoms alone ( n = 5). Eleven episodes met diagnostic criteria for persistent aura (>1 week) without infarction. The response was complete without early recurrence in 11 cases (50%), complete with recurrence in < 24 hours in two cases (9.1%), and partial with ≥ 50% improvement in six cases (27.3%). Complete responses without recurrence were more common in cases with prolonged auras lasting < 1 week than in those with persistent auras (72.7% vs. 27.3%; p = 0.033). Conclusions GON block could be an effective symptomatic treatment for prolonged or persistent migraine aura. Randomised controlled trials are still required to confirm these results.
Subject(s)
Anesthetics, Local/therapeutic use , Bupivacaine/therapeutic use , Migraine with Aura/drug therapy , Nerve Block/methods , Adult , Female , Humans , Male , Middle Aged , Pilot Projects , Treatment OutcomeABSTRACT
OBJECTIVE: Our aim was to report three new cases of lacrimal neuralgia and their response to superficial nerve blocks. BACKGROUND: Lacrimal neuralgia has been recently described as a pain in the territory supplied by the lacrimal nerve, at the lateral upper eyelid and/or the adjacent area of the temple. The pain is typically accompanied by tenderness on palpation of the lacrimal nerve at the superoexternal angle of the orbit. METHODS: Between January 2015 and June 2016, we prospective identified three cases of lacrimal neuralgia among the patients attending the Headache Unit in a tertiary hospital. Anesthetic blocks were performed in all cases by inserting a 30-G needle on the emergence of the nerve and injecting 0.5 cc of bupivacaine 0.5% subcutaneously. RESULTS: Three women aged 44, 49, and 51 presented with pain in the territory supplied by the lacrimal nerve. Two of them localized their pain in a small area of the right temple, while the remaining patient had pain in the right upper lateral eyelid and a small area of the lower lateral eyelid. The pain was continuous in two patients and episodic with attacks lasting 48 hours in one patient. All patients had tenderness on palpation of the lacrimal nerve. Anesthetic blocks confirmed the diagnosis of lacrimal neuralgia and provided the patients with long-lasting pain relief. CONCLUSIONS: Lacrimal neuralgia should be considered among the neuralgic causes of orbital and periorbital pain. Superficial nerve blocks may assist clinicians in the diagnosis and may also be a therapeutic option.