Modeling the impact of decreasing waiting period length for Medicaid sterilization: A multi-site cohort study.

OBJECTIVE: To evaluate the impact of length of the Medicaid sterilization waiting period and postpartum permanent contraception fulfillment. STUDY DESIGN: Simulations from a retrospective cohort study estimating the potential increase in permanent contraception within 365 days of delivery. RESULTS: In our sample of 2076 patients, 61% achieved permanent contraception with the current waiting period of 30 days. With the waiting period hypothetically reduced to 15, 3, 1, and 0 days, 62.9%, 63.7%, 64.5%, and 75% patients, respectively, would have achieved permanent contraception. CONCLUSIONS: As potential Medicaid sterilization policy revisions are considered, understanding the impact on fulfillment rates is critical.

A person-centered approach to characterizing longitudinal ambulatory impairment in Parkinson's disease.

Loss of ambulation is common and highly variable in Parkinson's disease (PD), and poorly understood from the perspectives of those with PD. Gaining insights to the anticipated perceived trajectories and their drivers, will facilitate patient-centered care. Latent class growth analysis, a person-centered mixture modelling approach, was applied to 16,863 people with PD stratified by early (N = 8612; < 3 years), mid (N = 6181; 3-10 years) and later (N = 2070; > 10 years) disease to discern clusters with similar longitudinal patterns of self-reported walking difficulty, measured by EuroQoL 5D-5L that is validated for use in PD. There were four clusters in early and mid-disease strata, with a fifth identified in later disease. Trajectories ranged from none to moderate walking difficulty, with small clusters with severe problems. The percentage of subjects with moderate (early = 17.5%, mid = 26.4%, later = 32.5%) and severe (early = 3.8%, mid = 7.4%, later = 15.4%) walking difficulty at baseline increased across disease duration groups. The trajectories tended to be stable with variability in moderate and severe groups. Across strata, clusters with moderate to severe problems were associated with more severe impairment, depression, anxiety, arthritis, higher BMI, lower income, and lower education, but no consistent race or gender differences. The findings reveal distinct longitudinal patterns in perceived difficulties in walking in PD.

Neighbourhood socioeconomic position, prenatal care and fulfilment of postpartum permanent contraception: Findings from a multisite cohort study.

Introduction: Research suggests neighbourhood socioeconomic vulnerability is negatively associated with women's likelihood of receiving adequate prenatal care and achieving desired postpartum permanent contraception. Receiving adequate prenatal care is linked to a greater likelihood of achieving desired permanent contraception, and access to such care may be critical for women with Medicaid insurance given that the federally mandated Medicaid sterilization consent form must be signed at least 30 days before the procedure. We examined whether adequacy of prenatal care mediates the relationship between neighbourhood socioeconomic position and postpartum permanent contraception fulfilment, and examined moderation of relationships by insurance type. Methods: This secondary analysis of a retrospective cohort study examined 3012 Medicaid or privately insured individuals whose contraceptive plan at postpartum discharge was permanent contraception. Path analysis estimated relationships between neighbourhood socioeconomic position (economic hardship and inequality, financial strength and educational attainment) and permanent contraception fulfilment by hospital discharge, directly and indirectly through adequacy of prenatal care. Multigroup testing examined moderation by insurance type. Results: After adjusting for age, parity, weeks of gestation at delivery, mode of delivery, race, ethnicity, marital status and body mass index, having adequate prenatal care predicted achieving desired sterilization at discharge (ß = 0.065, 95% confidence interval [CI]: 0.011, 0.117). Living in neighbourhoods with less economic hardship (indirect effect -0.007, 95% CI: -0.015, -0.001), less financial strength (indirect effect -0.016, 95% CI: -0.030, -0.002) and greater educational attainment (indirect effect 0.012, 95% CI: 0.002, 0.023) predicted adequate prenatal care, in turn predicting achievement of permanent contraception by discharge. Insurance status conditioned some of these relationships. Conclusion: Contact with the healthcare system via prenatal care may be a mechanism by which neighbourhood socioeconomic disadvantage affects permanent contraception fulfilment, particularly for patients with Medicaid. To promote reproductive autonomy and healthcare equity, future inquiry and policy might closely examine how neighbourhood social and economic characteristics interact with Medicaid mandates.

Longitudinal experience of food insecurity & cigarette use in the early COVID-19 Pandemic, United States.

Food insecurity is associated with cigarette smoking, yet little is known about how variability in the experience of food insecurity may relate to patterns of cigarette use. We sought to examine patterns of food insecurity and cigarette use during the COVID-19 pandemic (April 2020-March 2021). We analyzed longitudinal survey data from a nationally representative panel of adults in the United States (N = 7,880) from the Understanding Coronavirus in America Study. The primary independent variable was ten trajectories of food insecurity. Our dependent variable was past 7-day cigarette use (count of days used cigarettes). Poisson regression using generalized estimating equations was run controlling for key covariates. The prevalence of cigarette use on at least one day in the past week was lowest (17.5 %) for those who Remained Food Secure, and highest (57.9 %) among those who Became Fully Food Insecure, a group characterized by having high probability of becoming food insecure during the study period. Among those who reported at least one day of cigarette use in the past week, fewer than half (40.1 %) reported sustained use across all waves of the study. Those who Became Fully Food Insecure had an incidence rate ratio (IRR) of 1.73 (95 % CI: 1.18, 2.54) compared to those who Remained Food Secure with respect to number of smoking days. While different patterns of food insecurity are related to cigarette smoking at the population level, these results highlight that food insecurity, a key social need, may represent a novel strategy for informing reduction of tobacco use disparities.

Common Social and Health Disparities Contribute to Racial Differences in Ambulatory Impairment in Multiple Sclerosis.

BACKGROUND: We previously reported more rapid accrual of ambulatory impairments in Black compared to White individuals with relapsing remitting multiple sclerosis (RRMS) and higher body mass index (BMI). Hypertension and lower neighborhood socioeconomic status (SES) were associated with greater impairment, irrespective of race. We hypothesize that these common social and health inequities may explain a substantial portion of the racial differences in ambulation in American individuals with RRMS. METHODS: Causal mediation analyses investigated baseline and change-over-time mediators of ambulatory impairment differences between 1795 Black and White individuals with RRMS using a retrospective cohort study comprised of electronic health record data from 8491 clinical encounters between 2008 and 2015 where Timed 25-Foot Walk (T25FW) speeds without assistive devices were recorded. The hypothesis was that BMI, neighborhood SES, and hypertension were possible mediators. RESULTS: At baseline, Black individuals with RRMS (n = 175) had significantly slower T25FW speeds (5.78 vs 5.27 ft/s), higher BMI, a higher prevalence of hypertension, and they were more likely to live in lower-income neighborhoods than White individuals (n = 1,620). At baseline, a significant proportion (33.7%; 95% CI, 18.9%-59.4%) of the T25FW difference between Black and White individuals was indirectly due to a higher BMI (12.5%), hypertension burden (9.5%), and living in lower-income neighborhoods (11.2%). Once baseline mediation relationships were accounted for, there were no significant longitudinal mediation relationships. CONCLUSIONS: The findings implicate social and health disparities as prominent drivers of ambulatory differences between Black and White individuals with RRMS, suggesting that wellness and health promotion are essential components of MS care, particularly for Black individuals.

Contralaterally controlled functional electrical stimulation video game therapy for hand rehabilitation after stroke: a randomized controlled trial.

PURPOSE: To estimate the effect of integrating custom-designed hand therapy video games (HTVG) with contralaterally controlled functional electrical stimulation (CCFES) therapy. METHODS: Fifty-two stroke survivors with chronic (>6 months) upper limb hemiplegia were randomized to 12 weeks of CCFES or CCFES + HTVG. Treatment involved self-administration of technology-mediated therapy at home plus therapist-administered CCFES-assisted task practice in the lab. Pre- and post-treatment assessments were made of hand dexterity, upper limb impairment and activity limitation, and cognitive function. RESULTS: No significant between-group differences were found on any outcome measure, and the average magnitudes of improvement within both groups were small. The incidence of technical problems with study devices at home was greater for the CCFES + HTVG group. This negatively affected adherence and may partially explain the absence of effect of HTVG. At end-of-treatment, large majorities of both treatment groups had positive perceptions of treatment efficacy and expressed enthusiasm for the treatments. CONCLUSION: This study makes an important contribution to the research literature on the importance of environmental factors, concomitant impairments, and technology simplification when designing technology-based therapies intended to be self-administered at home. This study failed to show any added benefit of HTVG to CCFES therapy.Clinicaltrials.gov (NCT03058796).

Contralaterally controlled functional electrical stimulation (CCFES) is an emerging therapy for upper limb rehabilitation after stroke that is designed, in part, to be self-administered at home.While movement-soliciting video games have shown promise in rehabilitation, this study failed to show a significant added benefit of integrating CCFES with hand therapy video games.For technology-based therapies intended to be self-administered at home, this study brings to light the importance of making every component of rehabilitation technology as user friendly and trouble-free as possible.For technology-based therapies intended to be self-administered at home, this study brings to light the importance of assuring that the home environment is conducive to home-based therapy.

Study design and protocol for Nourishing Beginnings, an integrated service delivery model addressing food insecurity and social needs of low-income pregnant individuals.

BACKGROUND: Nourishing Beginnings is an integrated referral and service delivery model supporting Medicaid-eligible pregnant individuals by providing increased nutritional food access throughout pregnancy up to three months postpartum, through community health workers (CHW), who simultaneously address and provide support for social service needs of the client. METHODS: To study the impact of possible interventions on food security, the program includes two distinct interventions each paired with traditional CHW services, nutrition educational materials, and provision of basic essential cooking tools. Interventions consist of either bi-weekly home food delivery from the local food bank or bi-weekly financial assistance with healthy food access navigation. The study population consists of 160 pregnant individuals (18 or older,<22 weeks pregnant; 80 per intervention arm) who were referred to a countywide Pathways Community HUB (HUB), a community-based care coordination network that uses an evidence-based model to connect at-risk individuals to resources that address medical, social, economic, and behavioral health needs. Key data collection occurs at baseline, eight weeks after intervention begins, near delivery (36-38 weeks gestation), and three months postpartum. Intervention groups are compared to each other as well as against HUB historical controls and a concurrent matched sample from local Medicaid data. CONCLUSION: The goal of Nourishing Beginnings is to improve long-term health outcomes (i.e., maternal and infant) both directly and mediated through a set of proximal outcomes, including prenatal care, food security, diet and nutrition, reported race discrimination and psychosocial factors including depression, stress, healthy eating self-efficacy, and social support. Clinical Trials #: NCT05341960.

Long-term trajectories of ambulatory impairment in multiple sclerosis.

BACKGROUND: Ambulatory impairment is a common and complex manifestation of multiple sclerosis (MS), and longitudinal patterns are not well understood. OBJECTIVE: To characterize longitudinal walking speed trajectories in a general MS patient population and in those with early disease (⩽ 5 years from onset), identify subgroups with similar patterns, and examine associations with individual attributes. METHODS: Using a retrospective cohort study design, latent class growth analysis was applied to longitudinal timed 25-foot walk (T25-FW) data from 7683 MS patients, to determine T25-FW trajectories. Associations were evaluated between trajectory assignment and individual attributes. Analyses were repeated for 2591 patients with early disease. RESULTS: In the general patient population, six trajectories were discerned, ranging from very minimal to very high impairment at baseline, with variability in impairment accrual. The clusters with moderate to very high walking impairment were associated with being female, older and Black American, longer symptom duration, progressive course, and depressive symptoms. In the early disease subset, eight trajectories were discerned that included two subgroups that rapidly accrued impairment. CONCLUSION: We identified novel subgroups of MS patients will distinct long-term T25-FW trajectories. These results underscore that socially disadvantaged and economically marginalized MS patients are the most vulnerable for severe ambulatory impairment.

A new method for classifying prognostic risk factors in lung transplant candidates.

BACKGROUND: Predicting risk of waitlist mortality and subsequent classification of lung transplant candidates has been difficult due to inter-relatedness of risk factors, differential risk across populations, and changes in relationships over time. We developed a clinically intuitive indexing system to simplify mortality risk assessment. METHODS: Scientific Registry of Transplant Recipients data from February 19, 2015, to May 26, 2020 (n = 13,726) were used to estimate 3 constructs. Airway and oxygen function indices were estimated using confirmatory factor analysis and hierarchical clustering was used to derive respiratory support clusters. Cox proportional hazards regression was used to characterize event-free waitlist survival by constructs (3), age, sex, and diagnosis group. Model performance was compared to the Lung Allocation Score/Composite Allocation Score (LAS/CAS). RESULTS: Airway and oxygen function indices were created with substantive factor loadings forced expiratory volume (0.86), forced vital capacity (0.64), partial pressure of carbon dioxide (0.56) and PO2/fraction of inspired oxygen (0.83), partial pressure of oxygen (0.59), and mean pulmonary artery pressure (0.30), respectively. Four respiratory support clusters (C1: as needed O2, C2: continuous O2, C3: continuous O2/positive pressure ventilation (PPV), C4: PPV + extracorporeal membrane oxygenation) were identified. Constructs were used to identify patient profiles. Model area under the receiver operating characteristic curve was 0.85 [0.84, 0.87] compared to the LAS 0.92 [0.91, 0.94] at 4 weeks. Risk predictions were relatively insensitive to airway and oxygen function indices in C1 and C4 but varied across C2 and C3. CONCLUSIONS: Reducing the dimensionality of waitlist mortality risk offers an opportunity to identify clinical phenotypes that are more nuanced and thus more interpretable than current risk assessment provided by the LAS/CAS models.

Medicaid and Fulfillment of Postpartum Permanent Contraception Requests.

OBJECTIVE: To evaluate the association between Medicaid insurance and fulfillment of postpartum permanent contraception requests. METHODS: We conducted a retrospective cohort study of 43,915 patients across four study sites in four states, of whom 3,013 (7.1%) had a documented contraceptive plan of permanent contraception at the time of postpartum discharge and either Medicaid insurance or private insurance. Our primary outcome was permanent contraception fulfillment before hospital discharge; we compared individuals with private insurance with individuals with Medicaid insurance. Secondary outcomes were permanent contraception fulfillment within 42 and 365 days of delivery, as well as the rate of subsequent pregnancy after nonfulfillment. Bivariable and multivariable logistic regression analyses were used. RESULTS: Patients with Medicaid insurance (1,096/2,076, 52.8%), compared with those with private insurance (663/937, 70.8%), were less likely to receive desired permanent contraception before hospital discharge (P≤.001). After adjustment for age, parity, weeks of gestation, mode of delivery, adequacy of prenatal care, race, ethnicity, marital status, and body mass index, private insurance status was associated with higher odds of fulfillment at discharge (adjusted odds ratio [aOR] 1.48, 95% CI 1.17-1.87) and 42 days (aOR 1.43, 95% CI 1.13-1.80) and 365 days (aOR 1.36, 95% CI 1.08-1.71) postpartum. Of the 980 patients with Medicaid insurance who did not receive postpartum permanent contraception, 42.2% had valid Medicaid sterilization consent forms at the time of delivery. CONCLUSION: Differences in fulfillment rates of postpartum permanent contraception are observable between patients with Medicaid insurance and patients with private insurance after adjustment for clinical and demographic factors. The disparities associated with the federally mandated Medicaid sterilization consent form and waiting period necessitate policy reassessment to promote reproductive autonomy and to ensure equity.

Racial, ethnic and neighborhood socioeconomic differences in incidence of dementia: A regional retrospective cohort study.

BACKGROUND: Evidence on the effects of neighborhood socioeconomic disadvantage on dementia risk in racially and ethically diverse populations is limited. Our objective was to evaluate the relative extent to which neighborhood disadvantage accounts for racial/ethnic variation in dementia incidence rates. Secondarily, we evaluated the spatial relationship between neighborhood disadvantage and dementia risk. METHODS: In this retrospective study using electronic health records (EHR) at two regional health systems in Northeast Ohio, participants included 253,421 patients aged >60 years who had an outpatient primary care visit between January 1, 2005 and December 31, 2015. The date of the first qualifying visit served as the study baseline. Cumulative incidence of composite dementia outcome, defined as EHR-documented dementia diagnosis or dementia-related death, stratified by neighborhood socioeconomic deprivation (as measured by Area Deprivation Index) was determined by competing-risk regression analysis, with non-dementia-related death as the competing risk. Fine-Gray sub-distribution hazard ratios were determined for neighborhood socioeconomic deprivation, race/ethnicity, and clinical risk factors. The degree to which neighborhood socioeconomic position accounted for racial/ethnic disparities in the incidence of composite dementia outcome was evaluated via mediation analysis with Poisson rate models. RESULTS: Increasing neighborhood disadvantage was associated with increased risk of EHR-documented dementia diagnosis or dementia-related death (most vs. least disadvantaged ADI quintile HR = 1.76, 95% confidence interval = 1.69-1.84) after adjusting for age and sex. The effect of neighborhood disadvantage on this composite dementia outcome remained after accounting for known medical risk factors of dementia. Mediation analysis indicated that neighborhood disadvantage accounted for 34% and 29% of the elevated risk for composite dementia outcome in Hispanic and Black patients compared to White patients, respectively. CONCLUSION: Neighborhood disadvantage is related to the risk of EHR-documented dementia diagnosis or dementia-related death and accounts for a portion of racial/ethnic differences in dementia burden, even after adjustment for clinically important confounders.

Food Insecurity Trajectories in the US During the First Year of the COVID-19 Pandemic.

INTRODUCTION: The objective of this study was to characterize population-level trajectories in the probability of food insecurity in the US during the first year of the COVID-19 pandemic and to examine sociodemographic correlates associated with identified trajectories. METHODS: We analyzed data from the Understanding America Study survey, a nationally representative panel (N = 7,944) that assessed food insecurity every 2 weeks from April 1, 2020, through March 16, 2021. We used latent class growth analysis to determine patterns (or classes) of pandemic-related food insecurity during a 1-year period. RESULTS: We found 10 classes of trajectories of food insecurity, including 1 class of consistent food security (64.7%), 1 class of consistent food insecurity (3.4%), 5 classes of decreasing food insecurity (15.8%), 2 classes of increasing food insecurity (4.6%), and 1 class of stable but elevated food insecurity (11.6%). Relative to the class that remained food secure, other classes were younger, had a greater proportion of women, and tended to identify with a racial or ethnic minority group. CONCLUSION: We found heterogeneous longitudinal patterns in the development, resolution, or persistence of food insecurity during the first year of the COVID-19 pandemic. Experiences of food insecurity were highly variable across the US population, with one-third experiencing some form of food insecurity risk. Findings have implications for identifying population groups who are at increased risk of food insecurity and related health disparities beyond the first year of the pandemic.

Characterizing fatigue phenotypes with other symptoms and clinically relevant outcomes among people with multiple sclerosis.

PURPOSE: Fatigue is a common symptom of multiple sclerosis (MS) and can adversely affect all aspect of quality of life. The etiology of fatigue remains unclear, and its treatments are suboptimal. Characterizing the phenotypes of fatigued persons with MS may help advance research on fatigue's etiology and identify ways to personalize fatigue interventions to improve quality of life. The purpose of this study was to identify fatigue phenotypes; examine phenotype stability overtime; and characterize phenotypes by health and function, social and environmental determinants, psychosocial factors, and engagement in healthy behaviors. METHODS: We conducted a longitudinal study over a 3-month period with 289 fatigued participants with MS. To identify fatigue phenotypes and determine transition probabilities, we used latent profile and transition analyses with valid self-report measures of mental and physical fatigue severity, the mental and physical impact of fatigue, depression, anxiety, and sleep quality. We used ANOVAs and effect sizes to characterize differences among phenotypes. RESULTS: The best fitting model included six subgroups of participants: Mild Phenotype, Mild-to-Moderate Phenotype, Moderate-to-Severe Phenotype, Severe Phenotype, Fatigue-dominant Phenotype, and Mental Health-dominant Phenotype. The transition analysis indicated that phenotypic membership was highly stable. Variables with a large eta squared effect size included environmental barriers, self-efficacy, and fatigue catastrophizing. CONCLUSION: These results indicate that the magnitude of fatigue experienced may be more important to consider than the type of fatigue when characterizing fatigue phenotypes. Future research should explore whether tailoring interventions to environmental barriers, self-efficacy, and fatigue catastrophizing reduce the likelihood of transitioning to a more severe phenotype.

Evaluating and Modeling Neighborhood Diversity and Health Using Electronic Health Records.

BACKGROUND: Electronic health records (EHRs) provide researchers with abundant sample sizes, detailed clinical data, and other advantages for performing high-quality observational health research on diverse populations. We review and demonstrate strategies for the design and analysis of cohort studies on neighborhood diversity and health, including evaluation of the effects of race, ethnicity, and neighborhood socioeconomic position on disease prevalence and health outcomes, using localized EHR data. METHODS: Design strategies include integrating and harmonizing EHR data across multiple local health systems and defining the population(s) of interest and cohort extraction procedures for a given analysis based on the goal(s) of the study. Analysis strategies address inferential goals, including the mechanistic study of social risks, statistical adjustment for differences in distributions of social and neighborhood-level characteristics between available EHR data and the underlying local population, and inference on individual neighborhoods. We provide analyses of local variation in mortality rates within Cuyahoga County, Ohio. RESULTS: When the goal of the analysis is to adjust EHR samples to be more representative of local populations, sampling and weighting are effective. Causal mediation analysis can inform effects of racism (through racial residential segregation) on health outcomes. Spatial analysis is appealing for large-scale EHR data as a means for studying heterogeneity among neighborhoods even at a given level of overall neighborhood disadvantage. CONCLUSIONS: The methods described are a starting point for robust EHR-derived cohort analysis of diverse populations. The methods offer opportunities for researchers to pursue detailed analyses of current and historical underlying circumstances of social policy and inequality. Investigators can employ combinations of these methods to achieve greater robustness of results. HIGHLIGHTS: EHR data are an abundant resource for studying neighborhood diversity and health.When using EHR data for these studies, careful consideration of the goals of the study should be considered in determining cohort specifications and analytic approaches.Causal mediation analysis, stratification, and spatial analysis are effective methods for characterizing social mechanisms and heterogeneity across localized populations.

Heterogeneous pain trajectories in persons with Parkinson's disease.

INTRODUCTION: Pain is a common and complex symptom in Parkinson's disease. The underlying mechanisms and longitudinal patterns are not well understood, which impedes therapeutic decision making. The objectives of this study were to characterize longitudinal pain trajectories, identify clusters (subgroups) with similar patterns, and examine associations with sociodemographic and clinical characteristics. METHODS: Latent class growth analysis was applied to 16,863 people with Parkinson's disease stratified by early (N = 8612; <3 years), mid (N = 6181; 3-10 years) and later (N = 2070; >10 years) disease duration over ∼4.5 years (2017-2021) using the Fox Insight Data Exploration Network, to discern clusters of individuals with similar longitudinal patterns of self-reported pain. Associations were evaluated between cluster membership and sociodemographic and clinical factors. RESULTS: Across the disease duration strata, five clusters were identified. The clusters ranged from none to moderate pain, with a small cluster of subjects with severe pain. The percentage of subjects with moderate (early = 17.3%, mid = 24.2%, later = 34.4%) and severe (early = 2.3%, mid = 4.4%, later = 6.5%) pain at baseline increased across disease duration groups. The trajectories tended to be variable or slightly worsening in the early duration group, more stable in the mid duration group, and improving in the later duration group. Across strata, the clusters with moderate to severe pain were associated with more severe impairment, depression, anxiety and arthritis, higher body mass index, lower income, and lower education. CONCLUSION: This latent class growth analysis, applied to people with Parkinson's disease, provides a template for using self-reported outcomes to improve our understanding of pain trajectories.

Effects of waveform shape and electrode material on KiloHertz frequency alternating current block of mammalian peripheral nerve.

OBJECTIVES: KiloHertz frequency alternating current waveforms produce conduction block in peripheral nerves. It is not clearly known how the waveform shape affects block outcomes, and if waveform effects are frequency dependent. We determined the effects of waveform shape using two types of electrodes. MATERIALS AND METHODS: Acute in-vivo experiments were performed on 12 rats. Bipolar electrodes were used to electrically block motor nerve impulses in the sciatic nerve, as measured using force output from the gastrocnemius muscle. Three blocking waveforms were delivered (sinusoidal, square and triangular) at 6 frequencies (10-60 kHz). Bare platinum electrodes were compared with carbon black coated electrodes. We determined the minimum amplitude that could completely block motor nerve conduction (block threshold), and measured properties of the onset response, which is a transient period of nerve activation at the start of block. In-vivo results were compared with computational modeling conducted using the NEURON simulation environment using a nerve membrane model modified for stimulation in the kilohertz frequency range. RESULTS: For the majority of parameters, in-vivo testing and simulations showed similar results: Block thresholds increased linearly with frequency for all three waveforms. Block thresholds were significantly different between waveforms; lowest for the square waveform and highest for triangular waveform. When converted to charge per cycle, square waveforms required the maximum charge per phase, and triangular waveforms the least. Onset parameters were affected by blocking frequency but not by waveform shape. Electrode comparisons were performed only in-vivo. Electrodes with carbon black coatings gave significantly lower block thresholds and reduced onset responses across all blocking frequencies. For 10 and 20 kHz, carbon black coating significantly reduced the charge required for nerve block. CONCLUSIONS: We conclude that both sinusoidal and square waveforms at frequencies of 20 kHz or higher would be optimal. Future investigation of carbon black or other high charge capacity electrodes may be useful in achieving block with lower BTs and onsets. These findings will be of importance for designing clinical nerve block systems.

Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial.

BACKGROUND: Multi-site studies in stroke rehabilitation are important for determining whether a technology and/or treatment can be successfully administered by sites other than the originating site and with similar positive outcomes. This study is the first multi-site clinical trial of a novel intervention for post-stroke upper limb rehabilitation called contralaterally controlled functional electrical stimulation (CCFES). Previous pilot and single-site studies showed positive effects of CCFES on upper limb impairment and hand dexterity in stroke survivors. The main purpose of this study is to confirm and demonstrate the efficacy of CCFES in a larger group of most likely responders across multiple clinical sites. METHODS: Up to 129 stroke survivors with moderate to severe upper extremity hemiparesis at 4 clinical trial sites will be randomized to CCFES, cyclic neuromuscular electrical stimulation (cNMES), or task-oriented-training (TOT). Participants will receive 12 weeks of group-specific therapy. Blinded assessments of upper limb impairment and activity limitation, quality of life, and neurophysiology will be used to compare outcomes at baseline, after treatment, and up to 6 months post-treatment. The primary endpoint is change in dexterity from baseline to 6 months post-treatment. DISCUSSION: Loss of hand function following stroke is a major rehabilitation problem affecting millions of people per year globally. More effective rehabilitation therapies are needed to restore hand function in these individuals. This study will determine whether CCFES therapy produces greater improvements in upper extremity function than cNMES or TOT, and will begin to elucidate the different mechanisms underlying each of the three treatments. This multi-site study is a critical step in advancing a novel method of rehabilitation toward clinical translation and widespread dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT03574623 . Registered prior to first enrollment; July 2, 2018.

Disentangling self-reported fatigue, depression, and cognitive impairment in people with multiple sclerosis.

BACKGROUND: Fatigue is a common problem among people with multiple sclerosis (MS) and can have a negative effect on mental, physical, and social function. Self-reported measures of MS fatigue are often operationalized as a multi-dimensional symptom. However, questions remain about how best to account for the multi-dimensional aspects of self-reported fatigue and whether these aspects are distinct entities. Thus, the purpose of this study was to explore the overlap and distinctions between self-reported measures of the severity and impact of fatigue, between mental and physical fatigue, and between mental fatigue, depressive symptoms, and cognitive impairment. METHODS: An observational study was conducted with 289 participants with MS . The questionnaires were the Unidimensional Fatigue Impact Scale (UFIS), the Chalder Fatigue Scale (CFS), the Fatigue Scale for Motor and Cognitive Functions (FSMC), the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNSQ), and the Quality of Life in Neurological Disorders short form for depression (Neuro-QoL). Spearman's correlation coefficient was used to examine the bivariate correlations between composite and subscale scores. Exploratory structural equation modeling (ESEM) was used to determine the factor structure under a pre-specified number of factors to retain in the modeling of multiple items across questionnaires and examine model fit. Subsequently for poor fitting models in an iterative procedure to determine a better fitting multidimensional model, we posited a bifactor confirmatory factor analysis model. RESULTS: The bivariate correlation analysis revealed that subscales from the same questionnaire measuring different aspects of fatigue had the highest correlations (r = 0.61-0.68), subscales from different questionnaires measuring the same aspect of fatigue had the next highest correlations (r = 0.43-0.60), and subscales from different questionnaires measuring different aspects of fatigue had the lowest correlations (r = 0.34-0.40). Bifactor models with a general fatigue factor and subdomains pertaining to impact, severity, and mental and physical fatigue had relatively good model fits compared to models omitting the subdomains. However, an ESEM model using subscales from the CFS and FSMC fit poorly and did not adequately identify separate factors for mental and physical fatigue. An ESEM model with separate factors for self-reported mental fatigue, depressive symptoms, and cognitive impairment was a good fit. CONCLUSIONS: The working study hypothesis that fatigue constructs would be moderately correlated yet distinct entities was generally supported by the results of the study. However, we found that our hypothesized separation into a latent dimension existed only when the items or subscales came from the same questionnaire, in which case their level of specificity in terms of target, action, context, and time elements for measuring fatigue were consistent. The implications for the principle of compatibility in measuring self-reported MS fatigue are discussed.

Mechanisms of socioeconomic differences in COVID-19 screening and hospitalizations.

BACKGROUND: Social and ecological differences in early SARS-CoV-2 pandemic screening and outcomes have been documented, but the means by which these differences have arisen are not well understood. OBJECTIVE: To characterize socioeconomic and chronic disease-related mechanisms underlying these differences. DESIGN: Observational cohort study. SETTING: Outpatient and emergency care. PATIENTS: 12900 Cleveland Clinic Health System patients referred for SARS-CoV-2 testing between March 17 and April 15, 2020. INTERVENTIONS: Nasopharyngeal PCR test for SARS-CoV-2 infection. MEASUREMENTS: Test location (emergency department, ED, vs. outpatient care), COVID-19 symptoms, test positivity and hospitalization among positive cases. RESULTS: We identified six classes of symptoms, ranging in test positivity from 3.4% to 23%. Non-Hispanic Black race/ethnicity was disproportionately represented in the group with highest positivity rates. Non-Hispanic Black patients ranged from 1.81 [95% confidence interval: 0.91-3.59] times (at age 20) to 2.37 [1.54-3.65] times (at age 80) more likely to test positive for the SARS-CoV-2 virus than non-Hispanic White patients, while test positivity was not significantly different across the neighborhood income spectrum. Testing in the emergency department (OR: 5.4 [3.9, 7.5]) and cardiovascular disease (OR: 2.5 [1.7, 3.8]) were related to increased risk of hospitalization among the 1247 patients who tested positive. LIMITATIONS: Constraints on availability of test kits forced providers to selectively test for SARS-Cov-2. CONCLUSION: Non-Hispanic Black patients and patients from low-income neighborhoods tended toward more severe and prolonged symptom profiles and increased comorbidity burden. These factors were associated with higher rates of testing in the ED. Non-Hispanic Black patients also had higher test positivity rates.

Integrating patient-reported outcomes and quantitative timed tasks to identify relapsing remitting multiple sclerosis patient subgroups: a latent profile analysis.

BACKGROUND: Multiple sclerosis (MS) patients experience wide-ranging symptoms with varied severity, and approaches that integrate patient-reported outcomes and objective quantitative measures will present opportunities for advancing clinical profiling. The primary objective of the current study was to conduct exploratory data analysis using latent variable modeling to empirically identify clusters of relapsing remitting (RR) MS patients with shared impairment patterns across three patient-reported outcomes and two timed task measures. METHODS: Latent profile analyses and impairment data for 2,012 RRMS patients identified distinct patient clusters using timed task measures of upper and lower limb performance, and patient-reported outcomes measuring quality of life, depression symptom severity, and perceived global disability. Multinomial logistic regression models were used to characterize associations between socio-demographic attributes and assignment to the patient clusters. RESULTS: There were 6 distinct clusters of RRMS patients that differed by symptom patterns, and by their socio-demographic attributes. Most notable were were no differences in age, sex, or disease duration between the least and most impaired classes, representing 14% and 4% of patients, respectively. Patients in the most impaired class were much more likely to be Black American, have a history of smoking, have a higher body mass index, and be of lower socioeconomic status than the least impaired class. There were positive relationships between age and classification to clusters of increasing moderately severe impairment but not the most severe clusters. CONCLUSION: We present a framework for discerning phenotypic impairment clusters in RRMS. The results demonstrate opportunities for advancing clinical profiling, which is necessary for optimizing personalized MS care models and clinical research.