Multiple Sclerosis and the Risk of Infection: A Consensus Guideline

Multiple sclerosis (MS) is an inflammatory condition affecting the central nervous system. Infection is a major consideration in the MS population due to its relevance to several stages of the disease process: (i) it has been suggested that infective processes may be 'triggering' or aetiological factors for MS, (ii) concurrent infection is known to exacerbate symptoms in MS, (iii) people with MS are at higher risk of infection when compared to the general population, and this risk is exaggerated in those receiving disease modifying therapies (DMTs). This guidance document was developed by specialists in the field of MS, Immunology, Infectious Disease and Pharmacy. A modified Delphi approach was used to develop clinically relevant, evidence-based consensus guidelines to help physicians navigate the complex interaction between DMTs and infectious diseases. We focus on specific risks predisposing people with MS to infection and how to manage these risks. We also provide recommendations on how to screen for, prevent, and manage infection in this population, in particular tuberculosis, progressive multifocal leukoencephalopathy, hepatitis B, human papillomavirus, herpetic and other opportunistic infections. We also discuss vaccination and the COVID-19 pandemic in people on DMTs.

Best Quality of Care from a Distance (BQual-D): Maintaining high quality care for hormone receptor positive (HR+) metastatic breast cancer (MBC) during the COVID pandemic, patient participation and satisfaction with the program

Background During the COVID pandemic, we designed and implemented a program, called BQualD, to maintain high quality care for patients with HR+, HER2 negative MBC who were taking oral anti-cancer therapy and needed to shelter at home. This program augmented available clinical resources with (1) trained nurse coaches to manage side effects, improve adherence, monitor for cancer progression and screen for psychological distress via telehealth, and (2) a care coordinator to arrange blood testing at local labs to facilitate timely medication dose adjustments. BQual-D served patients from August 2020 through April 2021. Here, we describe survey results assessing patient (pt) satisfaction with BQual-D. Methods Pt's satisfaction surveys included questions rated on a Likert scale (1 "strongly disagree" to 5 "strongly agree") with questions regarding the following: satisfaction with the quality of the nurse coaching calls;perception that the nurse coach listened to what they were trying to convey;whether or not their needs were met by the nurse coaching calls;whether they felt that they received adequate explanation regarding the nurse coaching calls;whether they would recommend the nurse coaching calls to a friend;perception of whether or not the nurse coach was negative or critical towards them;whether or not they would do it over (i.e., if they would return to the nurse coaching calls);whether or not they felt that the nurse coach was friendly or warm toward them;they were able to more effectively deal with care and symptoms;they felt free to express themselves;they were able to focus on what was of real concern to them;the nurse seemed to understand what they were thinking and feeling. Patients were also asked how much the calls helped with their care and symptoms. Descriptive statistics are reported (i.e., frequencies and means). Results 84 pts were screened and contacted for the BQual-D program. Of the 64 pts who responded, 52 (81.3%) were interested and enrolled in BQual-D;12 (18.8%) declined. Among those who enrolled, 1 voluntarily withdrew, and 7 withdrew due to change in treatment. Participants had a mean age of 65 (range 36 - 88 yrs) and the following racial distribution -Caucasian/White (38, 73.1%), Black or African American (12, 23.1%), American Indian (1, 1.9%) and American Indian or Alaskan Native (1, 1.9%). Satisfaction surveys were received from 32 (50%) pts. Results of surveys regarding patient satisfaction with the nurse coach were generally positive. Pts agreed or strongly agreed that they were satisfied with the quality of the nurse coaching calls (94%), the nurse coach listened to what they were trying to convey (94%), their needs were met by the nurse coaching calls (91%), they understood the purpose of the call (90%), and they would recommend the nurse coaching calls to a friend (88%). The majority (74%) agreed or strongly agreed that they were able to more effectively deal with their care and symptoms after the nurse coach calls. When asked how much the calls helped their care and symptoms, 61% indicated that they made things a lot better, 19% indicated that they made things somewhat better, 16% indicated that they made no difference. One patient indicated that the calls made things somewhat worse. Conclusions During the COVID pandemic, when sheltering at home was encouraged, patient satisfaction with BQual-D, which provided additional health resources (nurse coaches, care coordinator) to support pts on oral therapy for HR+ MBC, was high. Resources needed to implement BQual-D should be explored as a way of providing additional support for pts to minimize the requirement for in-person visits. Funding(s): Supported by a grant from Pfizer.

Humoral and T- cell response to multiple COVID-19 booster vaccinations in people with MS

Introduction: People with multiple sclerosis (PwMS) treated with anti-CD20 therapies and fingolimod are less likely to successfully produce a humoral response to COVID-19 vaccines 1 and 2. Objective(s): To measure the humoral and/or cellular response to COVID-19 booster vaccinations in a cohort of PwMS who were previously seronegative after their initial COVID vaccine course. Aim(s): To determine whether there is a benefit of COVID-19 booster vaccinations for people with MS who are known to have had an attenuated response to initial vaccines. Method(s): We studied a cohort of PwMS all of whom were seronegative for anti-SARS-CoV-2 spike protein IgG after the 1st and 2nd COVID-19 vaccines, including PwMS treated with ocrelizumab (n=53), fingolimod (n=15), other DMTs (n=9) and no DMT (n=2). Dried blood spot +/- whole blood samples were obtained from participants at 2-8 weeks after their 3rd (n=79) and 4th (n=40) COVID-19 vaccines. Samples were used to measure anti-SARS-CoV-2 spike protein IgG (ELISA) and T-cell response (IFN-g release assay measured on whole blood). Result(s): Overall 27/79 (34%) who were seronegative after COVID vaccine 2 seroconverted after vaccine 3. Seroconversion rates were 17% for PwMS treated with ocrelizumab, 47% for fingolimod and 100% for other DMTs. A further 2/30 (7%) of those who remained seronegative after vaccine 3 seroconverted after vaccine 4. Anti-SARS-CoV-2 T-cell responses were measurable in 26/40 (65%) after vaccine 3 and 13/19 (68%) after vaccine 4 but were conspicuously absent in people treated with fingolimod. Overall, 75% of participants showed either humoral or cellular response after receiving 4 COVID vaccinations. PwMS with laboratory evidence of prior COVID-19 infection had higher measurable T-cell responses. Conclusion(s): Booster vaccinations for COVID-19 are associated with incremental benefits in measurable immunity in those with attenuated responses to the initial vaccine course. Overall, three quarters of those who were seronegative after COVID vaccines 1 & 2 had a measurable immune response after COVID vaccine 4. This data supports the use of booster vaccinations in pwMS at risk of attenuated vaccine response.

Generalized Weakness: Viral Infection or Myasthenic Crisis. A Case Report of MAB Intervention to Prevent Myasthenic Crisis

Background: Covid 19 has been shown to cause neurological manifestations due to direct infection by the virus or by the body's innate and adaptive immune response to infection.1,4 Patients with underlying neurological conditions can also be impacted by Covid 19 due to the use of immunosuppressant therapy. It can be challenging to determine in the emergency setting if symptoms are due to a viral infection versus the underlying neurologic condition. Sometimes therapies are withheld due to this uncertainty. Studies done during the ongoing Covid 19 pandemic, have shown an increased risk of hospitalization and death in Covid 19 patients with myasthenia gravis (MG) compared to those without. 2,3 Not much is known about the safety and efficacy of monoclonal antibody treatments for Covid 19 in myasthenic patients. Discussion(s): A 32-year-old woman with acetylcholine receptor positive MG presented to the Emergency Department (ED) with a 2 day history of fever, chills and bilateral upper and lower extremity weakness. She reported a fall and gait impairment for one day. Her last IVIG administration was in 2017. She was on azathioprine, prednisone and pyridostigmine, and was fully vaccinated for Covid 19 per CDC recommendations. Her blood pressure was 142/80, pulse rate 108, temperature 100.1 F and respiratory rate 18/minute. Significant neurological findings included power 3/5 in bilateral elbow and knee extensors, with the rest of the muscle groups at power 5/5. Covid PCR test was positive. Basic Laboratory investigations and a Chest X ray were unremarkable, and pulmonary mechanics, revealed a NIF of -50. The patient received a monoclonal antibody cocktail for Covid 19 infusion in the ED. She reported improvement and was discharged home after 48 hours. She was seen in clinic a month later and reported no residual symptoms. Conclusion(s): Monoclonal antibody treatment administered soon after the onset of symptoms is safe and may prevent myasthenic crisis. Treatment for Covid 19 and variants should not be withheld uniformly in patients with neuromuscular junction disorders.

Multiple sclerosis and COVID-19: Assessing risk perception, patient behaviors and access to disease-modifying therapies.

BACKGROUND: Following the outbreak of COVID-19, global healthcare systems have had to rapidly adapt. People with multiple sclerosis (pwMS) were required to make decisions about their individual risk and consequent work and social behaviors. This study aimed to evaluate risk perception and patterns of shielding behavior amongst pwMS at the onset of the COVID-19 pandemic and the subsequent impact on patients' employment and access to disease modifying therapies (DMTs). METHODS: Postal surveys were sent to 1690 people within a UK population-based MS cohort during the first wave of the COVID-19 pandemic. Patients were surveyed on: (i) perceived vulnerability to COVID-19; (ii) isolation behavior; (iii) interruption to DMT; (iv) employment status; (v) level of satisfaction with their current working arrangement. RESULTS: Responses were received from 1000 pwMS. Two thirds of patients reported isolating at home during the first wave of the pandemic. This behavior was associated with increased age (p<0.0001), higher disability (p<0.0001) and use of high-efficacy DMTs (p = 0.02). The majority of patients reported feeling vulnerable (82%) with perceived vulnerability associated with higher EDSS (p<0.0001) and receiving a high-efficacy DMT (p = 0.04). Clinician-defined risk was associated with shielding behavior, with those at high-risk more likely to self-isolate/shield (p<0.0001). Patients on high-efficacy DMTs were more likely to have an interruption to their treatment (50%) during the first wave of the pandemic. Most pwMS experienced a change to their working environment, and most were satisfied with the adjustments. CONCLUSION: This study highlights the risk perception, social behavioral practices and changes to treatment experienced by pwMS during the first wave of the COVID-19 pandemic in a large, well-described UK cohort. The results may help inform management of pwMS during future pandemic waves.

HOW DID THE COVID-19 PANDEMIC AFFECT UNMET NEED FOR CONDOMS AT A POPULATION LEVEL? (NATSAL-COVID)

Introduction Use of condoms to prevent STIs/HIV and unplanned pregnancy remains important during the COVID-19 pandemic. However, it is unknown whether the pandemic affected condom access and which population groups were most impacted. Methods 6658 participants (18-59y) completed a cross-sectional web survey one-year after the initial British lockdown from 23 March 2020. Quota-based sampling and weighting resulted in a sample that was quasi-representative of the British population. We report the prevalence of unmet need for condoms because of the pandemic among sexually-experienced participants aged 18-44 years (n=2869). Adjusted odds ratios (AOR) quantify associations with demographic and behavioural factors. Results Overall, 6.9% of women and 16.2% of men reported unmet need for condoms in the past year because of the pandemic. This was more likely to be reported by participants who: were aged 18-24 years vs. 35-44 (AOR: men 2.25 [95% CI:1.26-4.01], women 2.95[1.42-6.16]);were Black or Black British vs. White (men 2.86 [1.45-5.66], women 1.93 [1.03- 8.30]);reported same-sex sex vs. not (past five years;men 2.85 [1.68-4.86], women 5.00 [2.48-10.08]);or ≥1 new relationships vs. not (past year, men 5.85 [3.55-9.66], women 6.38 [3.24-12.59]). Men, but not women, reporting STIrelated service use (past year) were more likely to report unmet need for condoms compared to men that did not report service use (3.83 [2.18-6.71]). Discussion Unmet need for condoms because of the pandemic was more likely to be reported by populations at higher risk of adverse sexual health outcomes, including STI/HIV transmission. Improved access to free/low-cost condoms is crucial for all.

INEQUALITIES IN REPRODUCTIVE HEALTH OUTCOMES DURING COVID-19 IN BRITAIN: NATIONAL SURVEY (NATSAL COVID)

Introduction The COVID-19 pandemic presented challenges to delivery of reproductive health services. To explore effects, we examined patterns of contraceptive use, service access and pregnancy planning in the year following the first UK lockdown. Methods The Natsal-COVID Wave 2 survey was conducted in March-April 2021, one year after the first lockdown began in Britain. We analysed a subset of sexually-active participants aged 18-44 years and described as female at birth. We estimated differences in outcomes by age and markers of vulnerability. We examined changing contraception use, access to and unmet need for contraceptive services, and London Measure of Unplanned Pregnancy scores (LMUP;range 0-12). Results Of 1,488 eligible participants, 78.0% were considered at risk of unplanned pregnancies. Of 441 at-risk participants who tried to access contraceptive services, 16.4% faced barriers. Young participants (18-24 years) were most likely to report trying to access contraceptive services (38.4%;(32.2, 45.0);vs 28.4% overall) and to face barriers doing so (OR: 2.87 (1.36, 6.06)). Encountering barriers was more likely among participants reporting no educational qualifications and those reporting symptoms of anxiety or depression. 199 participants reported a pregnancy in the last year. Pregnancies to young participants were less likely to be 'planned' (difference in mean LMUP score: -2.95;(-3.91, -1.99)). Less 'planned' pregnancies were associated with lower social grades and becoming unemployed. Discussion Young and vulnerable participants were more likely to report difficulties accessing reproductive services and less planned pregnancies during the pandemic. In navigating pandemic recovery, sexual health services should consider the needs of these at-risk groups.

ETHNIC VARIATIONS IN SEXUAL RISK BEHAVIOUR, SEXUAL HEALTH SERVICE USE AND UNMET NEED DURING THE FIRST YEAR OF THE COVID-19 PANDEMIC: AN ANALYSIS OF POPULATION-BASED SURVEY AND SURVEILLANCE DATA

Introduction Prior to the COVID-19 pandemic, STIs disproportionately affected some Black communities. We examined ethnic inequalities in sexual health during the pandemic. Methods Analyses were restricted to England residents aged 18-59. We included 5,240 sexually-experienced participants from Natsal-COVID survey Wave 2 (quasi-representative web panel survey) reporting one-year outcomes from March 2020- April 2021. We estimated weighted proportions and adjusted odds ratios (AORs) between ethnicity and sexual risk behaviour (condomless sex with new partner on first occasion), sexual health service (SHS) use, and unmet need (trying but failing to access SHS). Using GUMCAD national surveillance data from before (March 2019-March 2020) and during (March 2020-March 2021) the pandemic, we compared proportional differences in rates of STI tests and diagnoses by ethnicity. Results Compared to Natsal-COVID participants of White ethnicity, sexual risk behaviour (8%) was higher among participants of Mixed/Other (22%, AOR:2.26 [95% CI 1.08-4.73]) and Asian (15%, 1.58 [1.07-2.35]);SHS use (5%) was higher in Black (20%, 3.04 [1.75-5.28]) and Mixed/Other (20%, 2.64 [1.35-5.14]);and unmet need (2%) was higher in Black (11%, 5.01 [2.26-11.09]) and Asian (5%, 2.33 [1.11-4.90]) ethnicity. In GUMCAD, among people attending SHS, we observed similar reductions of around 50% in testing and diagnoses during the pandemic across different ethnic groups, although the greatest reduction was in people of Asian ethnicity (56% and 52% respectively). Discussion Two independent national data sources showed sexual health inequalities persisted during the first year of the pandemic with evidence of more unmet need among minority ethnicities, but further work is needed to assess whether these worsened.

Black and brown women fostering authentic activism in counseling programs amid social unrest

The COVID-19 pandemic, racial injustice, and civil unrest of 2020 disproportionately impacted Black and Brown communities jolting "progressive" academic systems and exposing inherent inequities. Such inequality warrants authentic activism to promote social awareness and facilitate a culture of collaboration, respect, and inclusivity. This chapter centers on three early-career Black and Brown women leaders associated with counseling programs who voice their positionality statements, experiences, and views to align with relevant theoretical concepts. Black feminism, postcolonial feminism, and critical race theory pedagogies serve as the authors' foundation, highlighting race, culture, gender, and intersectionality to unmask cultural oppression in higher education. Committed to their lives' work as academics, researchers, and mental health practitioners, the authors assume substantial professional responsibilities and engage in emotional labor adopting a sense of family and mothering to support students. Finally, the authors provide suggestions to undo injustices during turbulent times. © 2021, IGI Global.

Best quality care from a distance (BQua D): Maintaining high quality care for hormone receptor positive (HR+) metastatic breast cancer (MBC) during the COVID pandemic, description of the program and provider satisfaction

Background: During the COVID pandemic, we designed and implemented a program, called BQual-D, to maintain high quality care for patients with HR+, HER2 negative MBC who were taking oral anti-cancer therapy and needed to shelter at home. This program augmented available clinical resources with (1) trained nurse coaches to manage side effects, improve adherence, monitor for cancer progression and screen for psychological distress via telehealth, and (2) a care coordinator to arrange blood testing at local labs to facilitate timely medication dose adjustments. BQual-D served patients from August, 2020 through April of 2021. Here, we describe survey results assessing provider satisfaction with BQual-D. Methods: Surveys assessing provider satisfaction were distributed in December, 2020 (Survey#1) and in April, 2021 (Survey#2). Provider demographics were collected with Survey#1. Eight questions assessed satisfaction with different aspects of the BQual-D program, including content of the nurse coach notes, communication with the program, timeliness of communication, frequency of notes, ease of reading the notes, ease of Sreferring patients, and turnaround time for labs, which were rated on a Likert scale of 1 (strongly dissatisfied) to 10 (strongly satisfied), with an additional response choice of 0 (unable to assess). Providers were also asked if BQual-D led to changes in patient management (yes/no), the degree to which BQual-D supported the medical management of the patient (from 1=not at all to 7=significantly), the influence of BQual-D on patient wellbeing (positive effects, no change, negative effects), and the overall quality of care delivered by the program (from 1=excellent to 4=poor). Finally, we asked providers if they would continue to recommend their patients to BQual-D (yes, in the same way as the program has been deployed;yes but with improvements;or no). Results are described by frequencies and means. Results: Nineteen providers responded to Survey#1. Providers were physicians (31.6%), advanced practice providers (31.6%), nurses (31.6%) and a clinical pharmacist (5.3%). Respondents were 89.5% female, 94.7% White, and had a mean age of 44 years and mean 11 years in practice. Providers rated the quality of care provided by the BQual-D program as excellent (44%) or good (57%), all providers surveyed indicated that they would continue to recommend the program to patients, and 95% of providers indicated that the program had a positive effect on patients' well-being. Half of the respondents indicated that BQual-D resulted in changes in or addition to patient management and 90% indicated that BQual-D significantly supported medical management. Providers were strongly satisfied (scores of 8-10 on the Likert scale) with overall communication with the BQual-D team (74%) and timeliness of communications (79%). Providers were also strongly satisfied with the content (68.4%), frequency (74%), and ease of reading (68%) program notes. Seven providers completed Survey#2, in which providers rated the overall quality of the program as excellent (57%) or good (43%);86% indicated that they would continue to recommend the program to patients, and 86% indicated that the program had a positive effect on patients' well-being. Conclusions: During the COVID pandemic, when sheltering at home was encouraged, provider satisfaction with BQual-D, which provided additional health resources (nurse coaches, care coordinator) to support patients on oral therapy for HR+ MBC, was high. Resources needed to implement BQual-D should be explored as a way of providing additional support for patients and providers in order to minimize the requirement for in-person visits.