Social models in leg care: understanding Lindsay Leg Club volunteering

Background: This qualitative exploratory research was the first study to explore Leg Club volunteering through focusing specifically on volunteers' narratives. Aim(s): The aim was to understand volunteers' motivations and experiences and to outline the crucial steps for maintaining volunteers' positive trajectory towards providing social support. Method(s): A qualitative study based on semi-structured interviews with volunteers from UK Leg Clubs was undertaken. Interview transcripts were analysed using a constructivist reflexive thematic analysis. Result(s): I recruited 16 volunteers from three UK Leg Clubs. The study explained the motivations for volunteering (started as members or companions;retired individuals with a strong sense of purpose;emotional, social and mental health reasons), experiences of volunteering (satisfaction from helping;meaningful social connections;personal growth) and volunteers' objectives (desire to recruit more volunteers;concerns about long-term capacity to return to pre-pandemic activities). Conclusion(s): The study outlines the conditions necessary for Leg Club volunteers' continued success in the social dimension of leg care. Declaration of Interest: Dr Anna Galazka is a volunteer project consultant for the Lindsay Leg Club Foundation. The research was funded by Cardiff Business School Research and Scholarship Seedcorn Funding Scheme.Copyright © 2023, OmniaMed Communications Ltd. All rights reserved.

The Impact of Teachers’ Level of Awe, Resilience, and Self-Compassion on Their Performance During the COVID-19 Pandemic

Emergency following the COVID-19 pandemic has forced educational institutions in over 190 countries to close, and teachers worldwide worked hard to adapt their curriculum to an online format and face multiple related challenges. The purpose of this quantitative study was to investigate the impact that the COVID-19 pandemic had on teachers’ performance and verify whether this change may have been justified by individual resilience, self-compassion and awe levels. The respondents perceived a significant drop in performance following the outbreak of the COVID-19 pandemic across all investigated subscales. Preliminary data obtained in this study indicate that this drop may be explained by a link between performance and Awe, Resilience and Self-Compassion. © 2022, Adam Marszalek Publishing House. All rights reserved.

Post-approval safety of cladribine tablets with particular reference to COVID-19 outcomes: An update

Introduction: The safety profile of cladribine tablets 10 mg (CladT;3.5 mg/kg cumulative dose over 2 years) from the phase III clinical development programme for relapsing multiple sclerosis (MS) is well characterised (Cook et al. MSaRD 2019;29:157- 167). Additional real-life safety data have accrued since the approval of CladT in >80 countries worldwide. Objectives: To update on the post-approval safety profile of CladT in patients with relapsing MS, with particular reference to COVID-19. Methods: We previously reported on outcomes for 46 CladTtreated patients with relapsing MS and confirmed or suspected COVID-19 (Jack et al. MSaRD 2020;46:102469). Here, we update on these findings, to 15 March 2021, based on cases reported to the Merck KGaA Global Patient Safety Database. Cases meeting the criteria of hospitalized, medically significant, or fatal were designated as serious, and outcomes were classified as per usual pharmacovigilance practice. Serious and non-serious adverse events (AEs) from post-approval sources (including spontaneous individual case safety reports, non-interventional postmarketing studies, and reports from other solicited sources) are also presented. Results: As of 15 March 2021, the safety database included 367 reported cases of COVID-19 in CladT-treated patients (confirmed by test, n=219;serious cases, n=49);6 patients had symptoms compatible with COVID-19 but were not evaluated further since they were subsequently reported to have negative PCR tests. Of 361 evaluable patients, a total of 187 (52%) were recovered/ recovering at the time of reporting;there was 1 fatality in a patient with suspected COVID-19. To date, 3357 AEs have been reported for the first 18,463 patients who received CladT post-approval;435 (13%) of these events were serious. Crude incidences for AEs of special interest: severe lymphopenia, 0.21%;herpes zoster, 1.07%;tuberculosis, 0.05%;severe infections, 1.23%;progressive multifocal leukoencephalopathy, 0%;opportunistic infections, 0.04%;malignancies, 0.23%;and congenital anomalies, 0%. Conclusions: Regarding COVID-19, CladT-treated patients do not appear to be at greater risk of serious disease and/or a severe outcome vs the general and MS populations. Overall, the postapproval safety profile of CladT is consistent with previously published safety findings from the clinical development programme and ongoing phase IV studies.

Updated post-approval safety of cladribine tablets in the treatment of multiple sclerosis, with particular reference to respiratory viral Infections and COVID-19

Objective: To update on the post-approval safety profile of cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years [CT3.5]) in patients with relapsing multiple sclerosis (MS), including COVID-19 and other respiratory viral infections. Background: Several integrated analyses have reported on the safety of CT3.5 during clinical development for treatment of relapsing MS. Additional real-life safety data have accrued since the approval of CT3.5 in many countries worldwide. In recent months the COVID-19 pandemic has become a concern for MS patients and their healthcare providers in terms of the associated safety of their disease-modifying therapy Design/Methods: Serious and non-serious adverse events (AEs) from post-approval sources (including spontaneous individual case safety reports, non-interventional post-marketing studies, and reports from other solicited sources) are presented to July 2020. AE rates are shown as crude incidences. Results: 3357 AEs were spontaneously reported for the first 18,463 patients who received CT3.5 post-approval;435 (13%) of these events were serious. Crude incidences for AEs of special interest: Severe lymphopenia, 0.21%;herpes zoster, 1.07%;tuberculosis, 0.05%;severe infections, 1.23%;progressive multifocal leukoencephalopathy, 0%;opportunistic infections, 0.04%;malignancies, 0.23%;and congenital anomalies, 0%. The pattern of respiratory viral infections (typically non-serious) with post-approval use of CT3.5 was also consistent with that of the clinical development program;crude incidences: H1N1 influenza, 0.01%;influenza, 0.68%;viral infection, 0.27%;and viral upper respiratory tract infection, 0.04%. As of 7 September 2020, the Merck KGaA safety database included 85 cases of suspected COVID-19 in CT3.5-treated patients (confirmed by test, n=38). An update on latest findings on COVID-19 infections will be presented, including analysis of time of infection since treatment where available. Conclusions: The safety profile of CT3.5, including respiratory viral infections, is consistent with previously published integrated safety analyses of the clinical development data.

The role of educational coaching in enhancing teachers’ well-being during pandemic

The coronavirus pandemic has turned out to be the biggest challenge the modern educational systems across the world have ever faced. Many teachers observed as their well-being plummeted as they started to overwhelmingly worry about the health of their families, as they were facing confusing instructions, unclear expectations or technical difficulties. The purpose of this qualitative study is to diagnose the role of educational coaching in stimulating the well-being of teachers during the pandemic of COVID-19. The results indicate that educational coaching can help teachers improve their well-being during the pandemic when teachers need to change their role – from classroom to remote – and succeed under a new set of circumstances. © 2021, Adam Marszalek Publishing House. All rights reserved.

Outcomes of COVID-19 in people with multiple sclerosis treated with cladribine tablets: an update

Background: The COVID-19 pandemic is a concern for people with multiple sclerosis (pwMS), especially those receiving disease-modifying therapies. Methods: We previously summarized outcomes for 46 pwMS treated with cladribine tablets (CladT) and confirmed or suspected COVID-19, as reported to the Merck KGaA Global Patient Safety Database (Jack et al., 2020). Here, we report an update to January 15, 2021 for 272 reported cases of COVID-19 among CladT-treated pwMS. Case definitions: confirmed = COVID-19 diagnostic test reported as positive;suspected = no confirmatory test performed/reported. Cases fulfilling the criteria of hospitalized, medically significant or fatal were designated as serious, while outcomes were classified per usual pharmacovigilance practice. Results: Evaluable cohort: 261 pwMS, median age 41 (range: 18–73) years, 70% female. Confirmed COVID-19, n=160;suspected, n=101 (an additional 11 pwMS with compatible COVID-19 symptoms were not evaluated further given negative PCR tests). Median time to COVID-19 since last CladT treatment course was 162 (range: 0–643) days (n=139). Outcomes: recovered/recovering, n=133 (51%);not recovered/not resolved, n=19 (7%);died, n=1 (0.5%);not reported/missing/pending, n=108 (41%). Of the evaluable cohort, 40 (15%) experienced serious COVID-19;demographics and outcomes were comparable among all patients. A single fatal case was reported of a woman aged 60 years with suspected COVID-19 who initiated CladT treatment in July 2019. No COVID-19 test result was reported. The patient died in December 2020. Conclusion: CladT-treated pwMS do not appear to be at greater risk of serious disease and/or a severe outcome with COVID-19 versus the general and MS populations.

Leg clubs and coronavirus: keeping a community feel in times of physical distancing

This article reported how some Leg Clubs have helped to maintain a community spirit and enable their members to continue to interact. The impact of the coronavirus pandemic has challenged everyone's day-to-day lives. The social distancing measures imposed by the government back in March required people in certain risk categories, such as the over 70s, to self-isolate for weeks. This inevitably has had a huge effect on many, as social relationships are vital for their wellbeing and quality of life.

Updated post-approval safety of cladribine tablets in the treatment of multiple sclerosis, with particular reference to respiratory viral infections

Background: Several integrated analyses have reported on the safety of cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years [CT3.5]) during clinical development for the treatment of patients with relapsing multiple sclerosis (RMS). Additional real-life safety data have accrued since the approval of CT3.5 in many countries worldwide. In recent months the COVID-19 pandemic has become a concern for MS patients and their healthcare providers in terms of the associated safety of their disease-modifying therapy. Objectives: To update on the post-approval safety profile of CT3.5 in patients with RMS, including COVID-19 and other respiratory viral infections. Methods: Serious and non-serious adverse events (AEs) from post-approval sources (including spontaneous individual case safety reports, non-interventional post-marketing studies, and reports from other solicited sources) are presented to Jan 2020. AE rates are shown as crude incidences (events/number of patients). Up-to-date COVID-19 findings are summarized. Results: A total of 2570 AEs were reported for the first 14,813 patients who received CT3.5 post-approval;303 (12%) events were classified as serious and none represented a new safety signal. Crude incidences for AEs of special interest were as follows: severe lymphopenia, 0.002;herpes zoster, 0.008;tuberculosis, 0.0004;severe infections, 0.009;progressive multifocal leukoencephalopathy, 0;opportunistic infections, 0.001;malignancies, 0.0015;and teratogenicity, 0. The majority of opportunistic infections were superficial dermal and mucosal fungal infections that resolved on standard treatments. The pattern of respiratory viral infections (typically non-serious) with post-approval use of CT3.5 was also consistent with that from the clinical development program;crude incidences were as follows: influenza, 0.005;viral infection, 0.002;and viral upper respiratory tract infection, 0.0004. As of 29 Jun 2020, the Merck safety database included 18 cases of confirmed COVID-19 in CT3.5-treated patients. An update on latest findings on COVID-19 infections will be presented, including analysis of time of infection since treatment where available. Conclusions: No new safety signals were identified in the realworld post-approval data of CT3.5, cumulative to Jan 2020. The safety profile of CT3.5, including respiratory viral infections, is consistent with previously published integrated safety analyses of the clinical development data.