Interventions to support risk and benefit understanding of disease-modifying drugs in Multiple Sclerosis patients:A systematic review

Objective: The present review evaluates interventions that have been designed to improve understanding of the complex risk-benefit profiles of disease-modifying drugs (DMDs) in patients with Multiple Sclerosis (MS). Methods: A systematic search conducted using PubMed, Embase, Google Scholar and PsycINFO identified 15 studies. Interventions which provided treatment information were present across a range of study designs. A narrative synthesis was conducted due to heterogeneity of research findings. Results: Interventions providing treatment information ranged from comprehensive education programmes to booklets of a few pages. MS patients favoured the interventions they received. Understanding of overall treatment information and treatment risks specifically, generally improved following interventions. Yet overestimation of treatment benefits persisted. There was no conclusive effect on DMD decisions. No superior intervention was identified. Conclusion: Interventions designed to improve understanding of DMD risk and benefit information are moderately successful. Practice implications: Additional support provided to MS patients beyond routine healthcare can generally improve understanding of the complex risk-benefit profiles of DMDs. Future interventions need to ensure that patients with symptoms that may confound understanding can also benefit from this additional information.</p

Best Methods of Communicating Clinical Trial Data to Improve Understanding of Treatments for Patients with Multiple Sclerosis

Background Patients’ understanding of treatment risks and benefits is a prerequisite for shared decision making. Yet, patients with multiple sclerosis (MS) do not accurately understand treatment information provided in regular clinical consultations. Objectives To identify the best methods of communicating clinical trial data to improve the understanding of treatments among patients with MS and to also examine the relationship between patients’ understanding with decisional conflict, individual traits, and MS symptoms. Methods A repeated-measures study was used. A sample of relapsing-remitting patients with MS was recruited from National Health Service sites in the United Kingdom. Patients were presented with hypothetical treatment risks and benefits from faux clinical trials. Treatments were communicated using absolute terms, relative terms, and numbers needed to treat/harm. The presence of baseline information with each method was also manipulated. Patients’ understanding and conflict in treatment decisions were assessed. Individual traits and MS symptoms were also recorded. Results Understanding was better when treatments were communicated in absolute terms (mean 3.99 ± 0.93) compared with relative terms (mean 2.93 ± 0.91; P < 0.001) and numbers needed to treat/harm (mean 2.89 ± 0.88; P < 0.001). Adding baseline information to all methods significantly improved understanding (mean 5.04 ± 0.96) compared with no baseline information (mean 1.50 ± 0.74; P < 0.001). Understanding was not related to conflict in treatment decisions (r = −0.131; P = 0.391). Numeracy, IQ, and cognitive impairments were significantly related to patients’ understanding of treatments. Conclusions Treatment risks and benefits should ideally be communicated using absolute terms, alongside baseline information. Patients with MS with low numeracy, low IQ, and reduced cognitive skills should be supported during treatment education

Multiple sclerosis patients' understanding and preferences for risks and benefits of disease-modifying drugs:A systematic review

Background: Multiple sclerosis (MS) patients are faced with complex risk-benefit profiles of disease-modifying drugs (DMDs) when making treatment decisions. For effective shared decision-making, MS patients should understand the risks and benefits of DMDs and make treatment decisions based on personal preferences. Methods: This is an inclusive systematic review to primarily assess current understanding of MS patients for information about DMDs provided during the standard healthcare system.The secondary aim assesses MS patients'preferences for specific risks and benefits of treatments. A systematic search was conducted using PubMed,Embase and Google Scholar. A total of 22 studies were reviewed across both aims. Relevant quantitative and qualitative data was extracted by two authors. A narrative synthesis was conducted due to heterogeneity of research findings. Results: There was a trend for DMD risks to be generally underestimated and DMD benefits to be generally overestimated by MS patients. Treatments that could potentially offer substantial symptom improvement, delay in disease progression, or reduction in relapses were preferred even at the expense of higher risks. Conclusions: Many patients' experience of information during the standard healthcare system does not provide satisfactory understanding of the risks and benefits of DMDs. Effective ways to communicate risk and benefit DMD information when making shared treatment decisions needs to be identified. Patient preferences of DMD risks and benefits should also be taken into accoun

Cognitive impairment among patients with multiple sclerosis:associations with employment and quality of life

OBJECTIVES To explore the relationship between cognitive impairment and conventional measures of disability in multiple sclerosis (MS), quality of life (QOL) and employment status using the brief international cognitive assessment for multiple sclerosis (BICAMS) in the routine outpatient clinic. METHODS 62 patients with MS were assessed on the BICAMS test battery for cognitive impairment. Data were obtained on employment status and a number of questionnaires completed including fatigue severity score, multiple sclerosis neuropsychological questionnaire, hospital anxiety and depression scale, the functional assessment of multiple sclerosis (FAMS) as well as on the EuroQOL five dimension questionnaire (EQ-5D). Other assessments include the patient activation measure and unidimensional self-efficacy scale for multiple sclerosis. RESULTS Cognitive assessment revealed 44 subjects (65%) had evidence of cognitive impairment on formal testing. In comparison with patients without evidence of cognitive impairment, cognitively impaired patients exhibited significantly higher rates of unemployment (p=0.009). The symbol digits modalities test was the most significant predictor of unemployment. Cognitive impairment was associated with lower QOL scores on the FAMS (p=0.001) and EQ-5D (p<0.001). CONCLUSIONS BICAMS provides a sensitive and easy to administer screening test for cognitive impairment within the outpatient setting. Cognitive impairment is common in our cohort of patients with MS attending outpatients and appears to be associated with increased rates of unemployment and lower measures of QOL

Health and social care workers experiences of coping while working in the frontline during the COVID-19 pandemic: One year on

BACKGROUND: The unprecedented pressure of working on the frontline during the Covid-19 pandemic had a demonstrable impact on the mental health and wellbeing of health and social care workers in the early stages of the pandemic, however, less research has focused on workers' experiences over the longer course of the pandemic. AIMS: We set out to develop an explanatory model of the processes that helped and hindered the coping of HSCWs working over the course of the Covid-19 pandemic. METHOD: Twenty HSCWs based in the UK took part in the study. They completed semi-structured interviews 12-18 months after the peak of the first wave in the UK. Interviews were transcribed and analysed using grounded theory methodology. RESULTS: The analysis identified eleven theoretical codes: personal context, organisational resources, organisational response, management, colleagues, decision-making and responsibilities, internal impacts, external impactors, safety, barriers to accessing support and temporal factors. The findings suggest that factors related to the individual themselves, their personal context, the organisation they work in, their managers, the support structures around them and their sense of safety impacted on HSCWs; ability to cope. Some factors changed over time throughout the first year of the pandemic, such as workload and staff illness, which further impacted HSCWs' coping. There were many barriers to accessing support that also impacted coping, including availability, awareness and time. The relationship between the factors that impacted coping are represented in an explanatory model. CONCLUSIONS: The findings extend previous studies on the mental health impact on frontline HSCWs working during Covid-19, providing novel insight by developing an explanatory model illustrating the underlying factors that impacted their coping experiences over the course of the pandemic in the UK. The findings from this study may assist in the development of improved and more effective support for HSCWs going forwards

Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study

Cladribine tablets; Multiple sclerosis; Quality of lifePastilles de cladribina; Esclerosi múltiple; Qualitat de vidaPastillas de cladribina; Esclerosis múltiple; Calidad de vidaBackground: Multiple sclerosis (MS) negatively affects health-related quality of life (HRQoL). Objective: To evaluate HRQoL in people with highly active relapsing MS treated with cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years) in CLARIFY-MS. Methods: Changes in the MS quality of life (MSQoL)-54 scores were analysed using a repeated mixed-effects linear model. Subgroup analyses were performed for participants who were pretreatment-naïve and those pretreated with disease-modifying therapies (DMTs) before initiating CladT. Safety and tolerability of CladT were also assessed. Results: MSQoL-54 physical (mean change = 4.86; 95% confidence interval (CI) = 3.18, 6.53) and mental health (4.80; 95% CI = 3.13, 6.46) composite scores (primary endpoints) showed significant improvement at Month 24 versus Baseline (p < 0.0001). Changes in the MSQoL-54 scores were consistent across the pretreatment-naïve and DMT-pretreated subgroups. No new severe or opportunistic infections occurred. Most post-baseline lymphopenia events were Grade 1–2 in severity. Transient Grade-3 lymphopenia was observed in 19.7% (95/482) of participants. Grade-4 lymphopenia was not observed. Conclusions: CladT treatment significantly improved the mean MSQoL-54 physical and mental health composite scores over 2 years. CladT efficacy in HRQoL, relapse rates and Expanded Disability Status Scale scores demonstrates its multidimensional effects in MS treatment.This work was supported by Merck (CrossRef Funder ID: 10.13039/100009945)

Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis: CLARIFY-MS study 6-month interim analysis

Cladribine tablets; Relapsing multiple sclerosis; Treatment satisfactionComprimidos de cladribina; Esclerosis múltiple recurrente; Satisfacción con el tratamientoComprimits de cladribina; Esclerosi múltiple recurrent; Satisfacció amb el tractamentBackground Multiple sclerosis (MS) is a chronic disabling disease that is associated with negative effects on health-related quality of life (HRQoL) due to reduced physical and psychosocial functioning. Cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years) have been approved for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS). The ongoing CLARIFY-MS study (NCT03369665; EudraCT number: 2017-002632-17) aims to assess the effect of cladribine tablets 3.5 mg/kg on HRQoL of patients with highly active RMS. Objective To report on the design of the CLARIFY-MS study, baseline patient characteristics, and results of a pre-planned interim analysis focusing on treatment satisfaction, safety, and tolerability that includes all data reported till 6 months after start of treatment. Methods The CLARIFY-MS study is a 2-year, open-label, single-arm, prospective, multicenter, phase IV study. Eligible patients with highly active RMS were assigned to receive cladribine tablets 3.5 mg/kg over 2 years. Treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM, v1.4; scale range from 0 to 100, higher values indicating higher satisfaction). Safety assessments, including occurrence of treatment-emergent adverse events (TEAEs; any adverse event reported after drug administration), serious adverse events (SAEs), and lymphocyte counts, were summarized descriptively. Results A total of 482 patients from 85 sites in Europe were treated with cladribine tablets. Mean patient age was 37.4 years, 338 (70.1%) were women, median EDSS was 2.5, and 345 (71.6%) were prior users of disease-modifying therapy (DMT). During the first 6 months after the start of treatment, and before reaching the full dose of cladribine tablets, mean TSQM global satisfaction score for the overall population was 70.4 (standard deviation, ± 18.48). The side effects score was 91.9 (± 17.68), convenience scored 86.6 (± 13.57), and effectiveness was 65.8 (± 21.14). A total of 275 patients (57.1%) reported at least one TEAE and 9 patients (1.9%) had a SAE. The majority of observed lymphopenia cases were of grade 1 or 2; 33 (6.8%) of the total study cohort had grade 3 lymphopenia, and no grade 4 lymphopenia was reported. Conclusion Patients reported high treatment satisfaction (TSQM) with cladribine tablets in this pre-planned interim analysis at 6 months. Few serious, and no unexpected, adverse events were reported, and there were no instances of grade 4 lymphopenia over the first 6 months. These preliminary data indicate good tolerability and convenience of administration of cladribine tablets in patients with highly active RMS.This study was sponsored by Merck Healthcare KGaA, Darmstadt, German