Disparities in Telehealth Care in Multiple Sclerosis.

Background and Objectives: The COVID-19 pandemic has dramatically increased telehealth use. We assessed access to and use of telehealth care, including videoconferencing and usability of videoconferencing, among persons with multiple sclerosis (MS). Methods: In Fall 2020, we surveyed participants in the North American Research Committee on Multiple Sclerosis Registry. Participants reported availability and receipt of MS care or education through telehealth. Participants who completed ≥1 live videoconferencing visit completed the Telehealth Usability Questionnaire (TUQ). We tested factors associated with access to and receipt of telehealth care using logistic regression. We tested factors associated with TUQ scores using quantile regression. Results: Of the 8,434 participants to whom the survey was distributed, 6,043 responded (71.6%); 5,403 were eligible for analysis. Of the respondents, 4,337 (80.6%) were women, and they had a mean (SD) age of 63.2 (10.0) years. Overall, 2,889 (53.5%) reported access to MS care via telehealth, and 2,110 (39.1%) reported receipt of MS care via telehealth including 1,523 (28%) via videoconference. Among participants who reported telehealth was available, older age was associated with decreased odds of having a telehealth video visit; higher income and being physically active were associated with increased odds. Older age and moderate to very severe visual symptoms were associated with lower perceived usability of telehealth. Discussion: Older age, lower socioeconomic status, and disease-related impairments are associated with less access to and use of telehealth services in people with MS. Barriers to telehealth should be addressed to avoid aggravating health care disparities when using digital medicine.

A mixed methods protocol to evaluate the effectiveness and acceptability of COVID-19 Community Assessment Hubs.

Background: Ireland's health system has been under significant strain due to staff shortages and inadequate capacity. Critical care bed capacity per capita in Ireland is among the lowest in Europe, thus, the coronavirus disease 2019 (COVID-19) pandemic has put additional strain on an over-stretched system. COVID-19 Community Assessment Hubs (CAHs) were established to mitigate unnecessary admission to acute hospitals, and reduce infection spread by supporting COVID-19 positive or suspected positive patients to isolate at home, or in isolation facilities. There is some evidence that similar assessment centres may be a successful triage strategy to reduce burden on hospital and acute care. Aim : The aim of this study is to evaluate the impact of COVID-19 Community Assessment Hubs on service delivery in one region in Ireland. Methods: A mixed-methods approach will be used, incorporating co-design to engage stakeholders and ensure informed data capture and analysis. Online surveys will assess CAH patients' experiences of access to and quality of care. Clinical patient data from CAHs will be collected and analysed using multinomial logistic regression to check for association with patient demographics and COVID-19 symptoms, and CAH early warning scores and outcomes (Transfer to Emergency Department, Transfer to isolation unit, Sent home with care plan). Semi-structured interviews will be conducted with: patients to elicit an in-depth understanding of experiences and acceptability of attending CAHs; and staff to understand challenges, benefits, and effectiveness of CAHs. Interview data will be analysed using a thematic analysis approach. Discussion: This study will provide valuable insights from both patient and staff perspectives on the operation of CAHs. We will evaluate the effectiveness and acceptability of CAHs and propose areas for improvement of the service. This will contribute to international literature on the use of community assessment centres during infectious disease pandemics.

A longitudinal assessment of depression and anxiety in the Republic of Ireland before and during the COVID-19 pandemic.

Few studies have examined changes in mental health before and after the outbreak of COVID-19. We examined changes in the prevalence of major depression and generalized anxiety disorder (GAD) between February 2019 and March-April 2020; if there were changes in major depression and GAD during six weeks of nationwide lockdown; and we identified factors that predicted major depression and GAD across the six-week lockdown period. Nationally representative samples of Irish adults were gathered using identical methods in February 2019 (N = 1020) and March-April 2020 (N = 1041). The latter was reassessed six weeks later. Significantly more people screened positive for depression in February 2019 (29.8% 95% CI = 27.0, 32.6) than in March-April 2020 (22.8% 95% CI = 20.2, 25.3), and there was no change in GAD. There were no significant changes in depression and GAD during the lockdown. Major depression was predicted by younger age, non-city dwelling, lower resilience, higher loneliness, and higher somatic problems. GAD was predicted by a broader set of variables including several COVID-19 specific variables. These findings indicate that the prevalence of major depression and GAD did not increase as a result of, or during the early phase of the COVID-19 pandemic in Ireland.

Importance of incorporating quantitative imaging biomarker technical performance characteristics when estimating treatment effects.

BACKGROUND/AIMS: Quantitative imaging biomarkers have the potential to detect change in disease early and noninvasively, providing information about the diagnosis and prognosis of a patient, aiding in monitoring disease, and informing when therapy is effective. In clinical trials testing new therapies, there has been a tendency to ignore the variability and bias in quantitative imaging biomarker measurements. Unfortunately, this can lead to underpowered studies and incorrect estimates of the treatment effect. We illustrate the problem when non-constant measurement bias is ignored and show how treatment effect estimates can be corrected. METHODS: Monte Carlo simulation was used to assess the coverage of 95% confidence intervals for the treatment effect when non-constant bias is ignored versus when the bias is corrected for. Three examples are presented to illustrate the methods: doubling times of lung nodules, rates of change in brain atrophy in progressive multiple sclerosis clinical trials, and changes in proton-density fat fraction in trials for patients with nonalcoholic fatty liver disease. RESULTS: Incorrectly assuming that the measurement bias is constant leads to 95% confidence intervals for the treatment effect with reduced coverage (<95%); the coverage is especially reduced when the quantitative imaging biomarker measurements have good precision and/or there is a large treatment effect. Estimates of the measurement bias from technical performance validation studies can be used to correct the confidence intervals for the treatment effect. CONCLUSION: Technical performance validation studies of quantitative imaging biomarkers are needed to supplement clinical trial data to provide unbiased estimates of the treatment effect.

The association of fatigue and social participation in multiple sclerosis as assessed using two different instruments.

INTRODUCTION: Fatigue is an important aspect of health-related quality of life and a commonly reported symptom by many persons with multiple sclerosis (MS). There are multiple validated instruments available to assess fatigue in MS with differing benefits for each instrument. OBJECTIVE: We aimed to assess the relationship between the PROMIS Fatigue instrument and the Fatigue Performance Scale (FPS) in the NARCOMS registry. Additionally, we aimed to examine the association of fatigue with social participation. METHODS: The NARCOMS registry is a voluntary, self-report registry, which has enrolled participants with MS who provide semi-annual updates regarding their MS. The Fall 2016 semi-annual survey included the PROMIS Fatigue and Ability to Participate in Social Roles and Activities questionnaires, in addition to demographic and clinical information. We examined the association between instruments using Spearman correlations. Linear and ordinal regression models were used to evaluate associations with fatigue using the PROMIS Fatigue and the FPS. RESULTS: Of the 7,006 Fall 2016 respondents, 6,883 (98.2%) completed the PROMIS instruments. Respondents were mostly female (79.5%) and Caucasian (87.4%), had a mean (SD) age of 59.9 (10.2) years and moderate disability level (median Patient Determined Disease Steps [PDDS] 4 [early cane]). The mean (SD) PROMIS Fatigue T-score was 56.8 (11.0) and median (25th, 75th) FPS was 3 [moderate] (1 [minimal], 4 [severe]). Fatigue measures were strongly correlated (r = 0.83, 95% CI: [0.827, 0.842]). Factors consistently associated with fatigue were PDDS level, depression and pain functionality scales, and symptoms worsening. The ability to participate in social roles and activities was strongly associated with fatigue and had an independent effect on fatigue after adjusting for PDDS, depression and pain levels. CONCLUSION: A high proportion of respondents experience some level of fatigue and it is independently associated with reduced social participation.

Assessment of Trauma Symptoms in Toddlers and Preschoolers Living in Poverty.

A first-line screening instrument, the Preschool Inventory of Trauma Symptoms (PITS), was developed to assess trauma symptoms with a diverse sample of 150 toddlers and preschoolers (M = 2.49 years; SD = 1.12). Items reflected the current trauma literature, assessment measures, and diagnostic criteria for very young children. A principal component analysis produced a 34-item, four-factor model: Arousal and Hyper-Reactivity, Fearful Attachment, Intrusion and Re-Experiencing, and Avoidance and Negative Cognition and Mood. One validity scale, Response Style, was also developed. All scales significantly correlated (r = .45 to .81; p < .01) with preestablished trauma measures and demonstrated adequate internal consistency (α = .68 - .87). A receiver operating characteristics curve analysis identified a cut-score with good discrimination ability (.88), sensitivity (.81), and specificity (.81). In a preliminary pilot study, PITS also was found to be sensitive to trauma symptom change following participation in an evidence-based trauma informed treatment program. A copy of the PITS is included in the Appendix for free use by qualified professionals.

Landscape of MS patient cohorts and registries: Recommendations for maximizing impact.

BACKGROUND: There is a growing number of cohorts and registries collecting phenotypic and genotypic data from groups of multiple sclerosis patients. Improved awareness and better coordination of these efforts is needed. OBJECTIVE: The purpose of this report is to provide a global landscape of the major longitudinal MS patient data collection efforts and share recommendations for increasing their impact. METHODS: A workshop that included over 50 MS research and clinical experts from both academia and industry was convened to evaluate how current and future MS cohorts could be better used to provide answers to urgent questions about progressive MS. RESULTS: The landscape analysis revealed a significant number of largely uncoordinated parallel studies. Strategic oversight and direction is needed to streamline and leverage existing and future efforts. A number of recommendations for enhancing these efforts were developed. CONCLUSIONS: Better coordination, increased leverage of evolving technology, cohort designs that focus on the most important unanswered questions, improved access, and more sustained funding will be needed to close the gaps in our understanding of progressive MS and accelerate the development of effective therapies.

Health insurance affects the use of disease-modifying therapy in multiple sclerosis.

OBJECTIVE: To evaluate the association between health insurance coverage and disease-modifying therapy (DMT) use for multiple sclerosis (MS). METHODS: In 2014, we surveyed participants in the North American Research Committee on MS registry regarding health insurance coverage. We investigated associations between negative insurance change and (1) the type of insurance, (2) DMT use, (3) use of free/discounted drug programs, and (4) insurance challenges using multivariable logistic regressions. RESULTS: Of 6,662 respondents included in the analysis, 6,562 (98.5%) had health insurance, but 1,472 (22.1%) reported negative insurance change compared with 12 months earlier. Respondents with private insurance were more likely to report negative insurance change than any other insurance. Among respondents not taking DMTs, 6.1% cited insurance/financial concerns as the sole reason. Of respondents taking DMTs, 24.7% partially or completely relied on support from free/discounted drug programs. Of respondents obtaining DMTs through insurance, 3.3% experienced initial insurance denial of DMT use, 2.3% encountered insurance denial of DMT switches, and 1.6% skipped or split doses because of increased copay. For respondents with relapsing-remitting MS, negative insurance change increased their odds of not taking DMTs (odds ratio [OR] 1.50; 1.16-1.93), using free/discounted drug programs for DMTs (OR 1.89; 1.40-2.57), and encountering insurance challenges (OR 2.48; 1.64-3.76). CONCLUSIONS: Insurance coverage affects DMT use for persons with MS, and use of free/discounted drug programs is substantial and makes economic analysis that ignores these supplements potentially inaccurate. The rising costs of drugs and changing insurance coverage adversely affect access to treatment for persons with MS.

Chronic cerebrospinal venous insufficiency: pitfalls and perils of sonographic assessment.

OBJECTIVES: Duplex sonography has been proposed as a diagnostic modality for detection of chronic cerebrovascular venous insufficiency, a recently proposed hypothesis of multiple sclerosis (MS) pathogenesis. We reviewed potential challenges of duplex sonography for diagnosis of chronic cerebrovascular venous insufficiency and used interim pooled data from a study aimed to apply cerebrovascular venous insufficiency criteria to a group of patients with MS and control patients without MS. METHODS: Duplex sonography for chronic cerebrovascular venous insufficiency was performed in patients with MS and controls. Extracranial and deep cerebral veins were studied by using a published chronic cerebrovascular venous insufficiency protocol and criteria. Comparative imaging was performed to explore how physiologic factors and imaging techniques could affect key parameters. The effects of varying definitions on fulfilling chronic cerebrovascular venous insufficiency diagnostic criteria were also explored. RESULTS: Forty-two patients were enrolled. Twenty-five (60%) had a reduction in internal jugular vein cross-sectional area by 50% or more, cross-sectional area of 0.3 cm(2) or less, and/or a B-mode abnormality. No patients had reflux longer than 0.88 seconds in both sitting and supine positions, the presence of duplex sonographic reflux on transcranial Doppler imaging, or a larger internal jugular vein cross-sectional area in the sitting versus supine position. Fourteen patients (33.3%) had either a flap or septum, and 1 had a web. Collateral veins to the vertebral veins were identified in 14 of 42 patients (33.3%). The use of transcranial Doppler imaging versus quality Doppler profiles resulted in fewer patients meeting criteria for chronic cerebrovascular venous insufficiency. CONCLUSIONS: There are several important variables, including physiologic, technical, and criterion definitions, in the application of sonographic assessment of chronic cerebrovascular venous insufficiency that may affect diagnostic accuracy.

Using data and quality monitoring to enhance maternity outcomes: a qualitative study of risk managers' perspectives.

INTRODUCTION: Risk management is a core part of healthcare practice, especially within maternity services, where litigation and societal costs are high. There has been little investigation into the experiences and opinions of those staff directly involved in risk management: lead obstetricians and specialist risk midwives, who are ideally placed to identify how current implementation of risk management strategies can be improved. METHODS: A qualitative study of consultant-led maternity units in an English region. Semistructured interviews were conducted with the obstetric and midwifery risk management leads for each unit. We explored their approach to risk management, particularly their opinions regarding quality monitoring and related barriers/issues. Interviews were recorded, transcribed and thematically analysed. RESULTS: Twenty-seven staff from 12/15 maternity units participated. Key issues identified included: concern for the accuracy and validity of their local data, potential difficulties related to data collation, the negative impact of external interference by national regulatory bodies on local clinical priorities, the influence of the local culture of the maternity unit on levels of engagement in the risk management process, and scepticism about the value of benchmarking of maternity units without adjustment for population characteristics. CONCLUSIONS: Local maternity risk managers may provide valuable, clinically relevant insights into current issues in clinical data monitoring. Improvements should focus on the accuracy and ease of data collation with a need for an agreed maternity indicators set, populated from validated databases, and not reliant on data collection systems that distract clinicians from patient activity and quality improvement. It is clear that working relationships between risk managers, their own clinical teams and external national bodies require improvement and alignment. Further discussion regarding benchmarking between maternity units is required prior to implementation. These findings are likely to be relevant to other clinical specialties.

Pragmatic language assessment in Williams syndrome: a comparison of the Test of Pragmatic Language-2 and the Children's Communication Checklist-2.

PURPOSE: Individuals with Williams syndrome (WS) are recognized as having a strong desire for social relationships, yet many of them have difficulty forming and maintaining peer relationships. One cause may be impairments in pragmatic language. The current study compared the assessment of pragmatic language skills in individuals with WS using the Test of Pragmatic Language-Second Edition (TOPL-2; Phelps-Terasaki & Phelps-Gunn, 2007) and the Children's Communication Checklist-Second Edition (CCC-2; Bishop, 2003). METHOD: Twenty children and adolescents diagnosed with WS were given the TOPL-2, and their parents completed the CCC-2. RESULTS: The TOPL-2 identified 8 of the 14 older children (ages 8-16 years) as having pragmatic language impairment and all of the 6 younger children (ages 6-7 years) as having such. In comparison, the CCC-2 identified 6 of the 14 older children and 2 of the 6 younger children as having pragmatic language impairment. The older group also had a higher composite score than the younger group on the CCC-2. CONCLUSION: The TOPL-2 identified significantly more participants as having pragmatic language impairment than did the CCC-2. The TOPL-2 may be more useful in assessing pragmatic language in older children than younger children. The results offer important preliminary clinical implications of language measures that may be beneficial in the assessment of individuals with WS.

Evaluation of a university-community partnership to provide home-based, mental health services for children from families living in poverty.

A university-community partnership is described that resulted in the development of community-based mental health services for young children from families living in poverty. The purpose of this pilot project was to implement an evidence-based treatment program in the homes of an at-risk population of children with significant emotional and behavior problems that were further complicated by developmental delays. Outcomes for 237 children who participated in the clinic's treatment program over a 2 year period are presented. Comparisons are included between treatment completers and non-completers and the issues of subject attrition, potential subject selection bias, and the generalizability of the results are addressed. The need for more professionals who are trained to address mental health issues in very young children who live in very challenging conditions are discussed.

Financial implications and maternal impact of national recommendations for thromboprophylaxis: a retrospective cross-sectional analysis.

BACKGROUND: Thromboembolism was a leading direct cause of maternal death in the UK in the last Saving Mothers' Lives report. National guidance proposes that all women should be risk assessed in pregnancy and after delivery. METHODS: An audit was designed to assess the financial implication for our service. One hundred consecutive live and stillbirths were identified using the maternity database; 97 case records were obtained. Risk factors were identified and individual scores were calculated, together with the proportion that would have extended measures (low-molecular-weight heparin [LMWH], antiembolic stockings). RESULTS: The series appeared to be representative of the UK pregnant population in terms of age, parity, body mass index, smoking and caesarean rate. Antenatally, 2.1% had a Royal College of Obstetricians and Gynaecologists (RCOG) risk score of three or more and would have been advised to have LMWH throughout pregnancy and the puerperium. Postnatally, 40.1% had an RCOG score of two or more and would have required enoxaparin for one to six weeks. The annual cost of stockings, LMWH and sharps bins approximate to GB£44,847 for every one thousand deliveries, GB£2.6 million for each life saved. About 10% of normal-weight postnatal women who achieved a vaginal birth had a risk score prompting thromboprophylaxis for at least seven days. CONCLUSIONS: These data suggest that the current guidance might represent overmedicalization of pregnancy and that the criteria for thromboprophylaxis should be refined further.

Attitudes toward safety and teamwork in a maternity unit with embedded team training.

The objective of this study was to identify any residual challenges in a unit with a track record of good clinical performance. A cross-sectional survey of frontline caregiver attitudes was conducted using a validated psychometric instrument. A total of 69% (91 of 132) of eligible participants completed questionnaires. The results indicated positive safety culture, teamwork climate, and job satisfaction. Perceptions of high workload and insufficient staffing levels were the most prominent negative observations but not to the detriment of job satisfaction or perception of work conditions. Male staff had consistently better safety attitudes in multivariate analyses. The authors identified 24-hour consultant (attending) presence and better support by management as prerequisites for further improvement. Teamwork and safety attitudes are positive in a unit with established interprofessional team training. Establishing better support by senior clinical and management leaders was identified as a necessary intervention to improve attitudes and safety.

A conceptual model of CME to address disparities in depression care.

The gap between best practices and actual practice in depression care--the difference between "what should be" and "what is"--is wider for ethnic and racial minorities than for the general population. Education alone is not reducing the gap or improving outcomes. Interventions such as the chronic care model have demonstrated improvements in physician performance and patient health status, both in the general population and among ethnic and racial minorities. Recent reviews of continuing medical education (CME) have shown that it is effective when the planned activities include (1) needs assessment and a focus on higher-level outcomes, (2) multiple ongoing activities that are sequenced for learning, (3) planning that considers the context in which the learned principles will be applied, (4) interactivity, and (5) active learning. The authors describe an approach to planning CME reflecting these five factors and suggest that CME planned in this way be combined with the chronic care model to enhance outcomes further.

Challenging behaviors in young children: the father's role.

In this study, the authors examined the parenting practices, developmental expectations, and stress levels of 136 fathers and the challenging and prosocial behaviors of their 1- to 5-year-old children. In addition, the authors systematically addressed fathers' qualitative concerns about their parenting. The authors divided the participants into 4 groups and controlled for family socioeconomic status (SES) and the focus child's gender. Results showed a significantly higher use of corporal and verbal punishment and parenting stress among lower income fathers. Secondary analyses demonstrated a significant effect of paternal disciplinary practices that emphasized the frequent use of corporal and verbal punishment on child behavior problems, regardless of SES level. On a positive note, fathers from both lower and higher SES groups had reasonable developmental expectations for their boys and girls, and they reported similar frequencies of their children's prosocial behavior. The authors discuss the need for early parent education programs that include fathers and that teach specific strategies to address child behavior problems.

Academic health sciences centres laid bare.

Academic Health Sciences Centres (AHSCs) are an enduring feature of health systems in all developed countries. In Canada, despite the lack of precise definition and standardized organizational arrangements, the educational services and programs in health sciences offered by AHSCs, and the caregiving organizations they embrace, are critical components of the national health system. Yet, the past decade has been a period of profound change in the Canadian health system. The pace of this change and the nature of the demands on the system are unlikely to abate in the near future. Given that many of these changes have directly impacted on AHSCs, or their component parts, it is timely to review these entities and to understand more fully how these organizations have been, or may be, affected in the future.