Global Peginterferon Beta-1a Tolerability Management Best Practices: A Nurse-Focused Delphi Approach.

INTRODUCTION: Injection site reactions (ISRs) and flu-like symptoms (FLS) are common in patients with relapsing forms of multiple sclerosis (MS) treated with peginterferon beta-1a. The purpose of this Delphi analysis was to explore peginterferon beta-1a discontinuation rates across MS treatment centers, to obtain consensus on effective mitigation and management strategies for ISRs and FLS, and to identify areas where additional training and education for nurses and patients could improve treatment outcomes. METHODS: In this modified Delphi process, an international steering committee of eight MS-certified nurses developed two rounds of surveys, which were completed by 262 and 188 MS nurses, respectively, representing nine countries. RESULTS: On average, nurses reported that 25% and 30% of patients treated with peginterferon beta-1a experienced ISRs and FLS, respectively. Discontinuation due to severe ISRs or FLS was most common in the first 6 months of treatment, yet follow-up visits typically took place 6 months after peginterferon beta-1a initiation. Preferred management strategies for ISRs included nonsteroidal anti-inflammatory drugs and rotation of the injection site, whereas preferred management strategies for FLS included acetaminophen/paracetamol and hydration/nutrition. Most nurses (77%) agreed that additional education and training on ISR and FLS management would bolster their confidence in treating patients with these symptoms. CONCLUSION: Delphi respondents reached consensus on ISR and FLS management strategies, which can help to inform treatment decisions. The results of this global Delphi analysis indicate that management of ISRs and FLS could be improved with more frequent follow-up visits and individualized training and education.

Recommendations for cognitive screening and management in multiple sclerosis care.

PURPOSE: To promote understanding of cognitive impairment in multiple sclerosis (MS), recommend optimal screening, monitoring, and treatment strategies, and address barriers to optimal management. METHODS: The National MS Society ("Society") convened experts in cognitive dysfunction (clinicians, researchers, and lay people with MS) to review the published literature, reach consensus on optimal strategies for screening, monitoring, and treating cognitive changes, and propose strategies to address barriers to optimal care. RECOMMENDATIONS: Based on current evidence, the Society makes the following recommendations, endorsed by the Consortium of Multiple Sclerosis Centers and the International Multiple Sclerosis Cognition Society: Increased professional and patient awareness/education about the prevalence, impact, and appropriate management of cognitive symptoms. For adults and children (8+ years of age) with clinical or magnetic resonance imaging (MRI) evidence of neurologic damage consistent with MS: As a minimum, early baseline screening with the Symbol Digit Modalities Test (SDMT) or similarly validated test, when the patient is clinically stable; Annual re-assessment with the same instrument, or more often as needed to (1) detect acute disease activity; (2) assess for treatment effects (e.g. starting/changing a disease-modifying therapy) or for relapse recovery; (3) evaluate progression of cognitive impairment; and/or (4) screen for new-onset cognitive problems. For adults (18+ years): more comprehensive assessment for anyone who tests positive on initial cognitive screening or demonstrates significant cognitive decline, especially if there are concerns about comorbidities or the individual is applying for disability due to cognitive impairment. For children (<18 years): neuropsychological evaluation for any unexplained change in school functioning (academic or behavioral). Remedial interventions/accommodations for adults and children to improve functioning at home, work, or school.

Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.

Disease modifying therapies (DMTs) reduce the frequency of relapses and accumulation of disability in multiple sclerosis (MS). Long-term persistence with treatment is important to optimize treatment benefit. This long-term, cohort study was conducted at the Calgary MS Clinic. All consenting adults with relapsing-remitting MS who started either glatiramer acetate (GA) or interferon-ß 1a/1b (IFN-ß) between January 1st, 1996 and July 1st, 2011 were included. Follow-up continued to February 1st, 2014. Time-to-discontinuation of the initial and subsequently-prescribed DMTs (switches) was analysed using Kaplan-Meier survival analyses. Group differences were compared using log-rank tests and multivariable Cox regression models. Analysis included 1471 participants; 906 were initially prescribed GA and 565 were initially prescribed IFN-ß. Follow-up information was available for 87%; 29 (2%) were lost to follow-up and 160 (11%) moved from Southern Alberta while still using DMT. Median time-to-discontinuation of all injectable DMTs was 11.1 years. Participants with greater disability at treatment initiation, those who started treatment before age 30, and those who started between 2006 and 2011 were more likely to discontinue use of all injectable DMTs. Median time-to-discontinuation of the initial DMT was 8.6 years. Those initially prescribed GA remained on treatment longer. Of 610 participants who discontinued injectable DMT, 331 (54%) started an oral DMT, or a second-line DMT, or resumed injectable DMT after 90 days. Persistence with injectable DMTs was high in this long-term population-based study. Most participants who discontinued injectable DMT did not remain untreated. Further research is required to understand treatment outcomes and outcomes after stopping DMT.

Multiple sclerosis, relapses, and the mechanism of action of adrenocorticotropic hormone.

Relapses in multiple sclerosis (MS) are disruptive and frequently disabling for patients, and their treatment is often a challenge to clinicians. Despite progress in the understanding of the pathophysiology of MS and development of new treatments for long-term management of MS, options for treating relapses have not changed substantially over the past few decades. Corticosteroids, a component of the hypothalamic-pituitary-adrenal axis that modulate immune responses and reduce inflammation, are currently the mainstay of relapse treatment. Adrenocorticotropic hormone (ACTH) gel is another treatment option. Although it has long been assumed that the efficacy of ACTH in treating relapses depends on the peptide's ability to increase endogenous corticosteroid production, evidence from research on the melanocortin system suggests that steroidogenesis may only partly account for ACTH influences. Indeed, the melanocortin peptides [ACTH and α-, ß-, γ-melanocyte-stimulating hormones (MSH)] and their receptors (Melanocortin receptors, MCRs) exert multiple actions, including modulation of inflammatory and immune mediator production. MCRs are widely distributed within the central nervous system and in peripheral tissues including immune cells (e.g., macrophages). This suggests that the mechanism of action of ACTH includes not only steroid-mediated indirect effects, but also direct anti-inflammatory and immune-modulating actions via the melanocortin system. An increased understanding of the role of the melanocortin system, particularly ACTH, in the immune and inflammatory processes underlying relapses may help to improve relapse management.

Use of Magnetic Resonance Imaging as Well as Clinical Disease Activity in the Clinical Classification of Multiple Sclerosis and Assessment of Its Course: A Report from an International CMSC Consensus Conference, March 5-7, 2010.

It has recently been suggested that the Lublin-Reingold clinical classification of multiple sclerosis (MS) be modified to include the use of magnetic resonance imaging (MRI). An international consensus conference sponsored by the Consortium of Multiple Sclerosis Centers (CMSC) was held from March 5 to 7, 2010, to review the available evidence on the need for such modification of the Lublin-Reingold criteria and whether the addition of MRI or other biomarkers might lead to a better understanding of MS pathophysiology and disease course over time. The conference participants concluded that evidence of new MRI gadolinium-enhancing (Gd+) T1-weighted lesions and unequivocally new or enlarging T2-weighted lesions (subclinical activity, subclinical relapses) should be added to the clinical classification of MS in distinguishing relapsing inflammatory from progressive forms of the disease. The consensus was that these changes to the classification system would provide more rigorous definitions and categorization of MS course, leading to better insights as to the evolution and treatment of MS.

Assessing relapses and response to relapse treatment in patients with multiple sclerosis: a nursing perspective.

There are currently no assessment tools that focus on evaluating patients with multiple sclerosis (MS) who are experiencing a relapse or that evaluate patients' response to acute relapse treatment. In practice, assessments are often subjective, potentially resulting in overlooked symptoms, unaddressed patient concerns, unnoticed or underrecognized side effects of therapies (both disease modifying and symptomatic), and suboptimal therapeutic response. Systematic evaluation of specific symptoms and potential side effects can minimize the likelihood of overlooking important information. However, given the number of potential symptoms and adverse events that patients may experience, an exhaustive evaluation can be time-consuming. Clinicians are thus challenged to balance thoroughness with brevity. A need exists for a brief but comprehensive objective assessment tool that can be used in practice to 1) help clinicians assess patients when they present with symptoms of a relapse, and 2) evaluate outcomes of acute management. A working group of expert nurses convened to discuss recognition and management of relapses. In this article, we review data related to recognition and management of relapses, discuss practical challenges, and describe the development of an assessment questionnaire that evaluates relapse symptoms, the impact of symptoms on the patient, and the effectiveness and tolerability of acute treatment. The questionnaire is designed to be appropriate for use in MS specialty clinics, general neurology practices, or other practice settings and can be administered by nurses, physicians, other clinicians, or patients (self-evaluation). The relapse assessment questionnaire is currently being piloted in a number of practice settings.

Improvements in care and reduced self-management barriers among rural patients with diabetes.

CONTEXT: Improved preventive care and clinical outcomes among patients with diabetes can reduce complications and costs; however, diabetes care continues to be suboptimal. Few studies have described effective strategies for improving care among rural populations with diabetes. PURPOSE: In 2000, the Park County Diabetes Project and the Montana Diabetes Control Program collaboratively implemented a countywide effort, which included health systems interventions and coordinated diabetes education, to improve the quality of diabetes care. METHODS: Clinical data from the diabetes registries in 2 primary care practices, in addition to baseline and follow-up telephone surveys, were used to evaluate improvements in care, outcomes, education, and barriers to self-management. FINDINGS: In the cohort of patients, the proportion receiving the following services increased significantly from 2000 to 2003: annual foot examination (43% to 58%), influenza (30% to 53%), and pneumoccocal immunizations (39% to 70%). The median hemoglobin A1c values decreased significantly from baseline to follow-up (7.2% to 6.8%). Mean systolic and diastolic blood pressure decreased significantly over the 2 time periods (139 mmHg to 135 mmHg, and 78 mmHg to 75 mmHg, respectively). Significant decreases were also observed in barriers to self-management, including lack of knowledge (decrease from 12% to 5%), difficulties making lifestyle changes (36% to 27%), cost of monitors and test strips (25% to 16%), cost of medications (37% to 24%), and diabetes education (22% to 4%). CONCLUSIONS: Findings suggest that system changes in primary care practices and the implementation of accessible diabetes education can improve care and reduce barriers for rural patients with diabetes.

Long-term treatment optimization in individuals with multiple sclerosis using disease-modifying therapies: a nursing approach.

The introduction of disease-modifying therapies (DMTs) for multiple sclerosis (MS) over the last 7 years has had a significant effect on the management of those living with this disease. Initially, the focus of improving treatment outcomes was on ensuring adherence to therapy by managing drug-related adverse events. However, treatment adherence is only one facet of ensuring optimal health outcomes for patients using DMTs. Therefore, a group of 80 nurses from Canada and the United States (The North American MS Nurses' Treatment Optimization Group) developed an evidence-based nursing approach to address the various factors involved in obtaining optimal patient outcomes. The goal of this nursing approach is to ensure the best possible clinical, subclinical, psychosocial, and quality-of-life outcomes for patients with MS using DMTs.

Differential diagnosis and management of fatigue in multiple sclerosis: considerations for the nurse.

Fatigue is one of the most disabling aspects of multiple sclerosis (MS), affecting an estimated 70%-90% of patients. Yet, despite its prevalence, it is also one of the most difficult MS symptoms to accurately diagnose and effectively treat. This is because of numerous factors, including the subjective and nonspecific nature of fatigue; its variable manifestations; its similarity to psychological, motor, cognitive, respiratory, and non-MS-related disturbances and conditions; and a lack of understanding of its precise etiology. In contrast to fatigue experienced by people without MS, MS fatigue is characterized by its persistence and sensitivity to core and ambient temperatures. Differential diagnosis of MS fatigue is largely dependent on delineating chronic versus acute onset and determining whether fatigue is a symptom in and of itself (primary MS fatigue) or an aspect of an MS-related or non-MS-related etiology (secondary MS fatigue). Once the presence of fatigue is established, a through medical history, physical examination, and fatigue assessments can guide effective management, which includes education, self-care strategies, and pharmacological treatment. As patient advocates and gatekeepers, MS nurses are in an optimal position to establish and evaluate fatigue as a symptom in and of itself and effectively guide this process.