Effects of Gut Microbiome Modulation on Reducing Adverse Health Outcomes among Elderly and Diabetes Patients during the COVID-19 Pandemic: A Randomised, Double-Blind, Placebo-Controlled Trial (IMPACT Study).

Gut microbiota is believed to be a major determinant of health outcomes. We hypothesised that a novel oral microbiome formula (SIM01) can reduce the risk of adverse health outcomes in at-risk subjects during the coronavirus disease 2019 (COVID-19) pandemic. In this single-centre, double-blind, randomised, placebo-controlled trial, we recruited subjects aged ≥65 years or with type two diabetes mellitus. Eligible subjects were randomised in a 1:1 ratio to receive three months of SIM01 or placebo (vitamin C) within one week of the first COVID-19 vaccine dose. Both the researchers and participants were blinded to the groups allocated. The rate of adverse health outcomes was significantly lower in the SIM01 group than the placebo at one month (6 [2.9%] vs. 25 [12.6], p < 0.001) and three months (0 vs. 5 [3.1%], p = 0.025). At three months, more subjects who received SIM01 than the placebo reported better sleep quality (53 [41.4%] vs. 22 [19.3%], p < 0.001), improved skin condition (18 [14.1%] vs. 8 [7.0%], p = 0.043), and better mood (27 [21.2%] vs. 13 [11.4%], p = 0.043). Subjects who received SIM01 showed a significant increase in beneficial Bifidobacteria and butyrate-producing bacteria in faecal samples and strengthened the microbial ecology network. SIM01 reduced adverse health outcomes and restored gut dysbiosis in elderly and diabetes patients during the COVID-19 pandemic.

End user evaluation of a Kneeling Wheelchair with "on the fly" adjustable seating functions.

A "kneeling" ultralight wheelchair prototype has been developed that allows users to adjust seat position "on the fly" for different activities throughout the day. The wheelchair includes independent adjustment functions for rear seat height, front seat height ("kneeling") and backrest angle.  Aim: This work aimed to gather feedback about the wheelchair's functionality and performance through end user evaluation trials.  Methods: Eight manual wheelchair users evaluated the prototype Kneeling Wheelchair for a range of activities. User perspectives on parameters such as usability, comfort, stability and effectiveness were obtained through both open-ended and Likert-scale rating questions.  Results: Results indicate several potential benefits of the adjustment functions of the Kneeling Wheelchair. Rear seat height adjustment may facilitate a number of activities of daily living, as well as provide benefits for comfort and social interactions. Back rest adjustment may increase comfort and stability on slopes. Front seat height adjustment may be beneficial for transfers and conducting sustained low-to-the-ground activities. While benefits of this adjustment function were described by many participants, some struggled with usability of the kneeling mechanism and rated this function less favourably than the other two.  Conclusion: The findings of this study will inform future iterations of the Kneeling Wheelchair design and may spur future developments in wheeled mobility. In the long-term, it is anticipated that novel wheelchair solutions, such as the one described in this paper, may support improved health, quality of life and community participation for people with mobility impairments. Implications for rehabilitation Wheelchairs that allow users to easily adjust seat and backrest position "on the fly" to better suit different tasks throughout the day may provide benefits such as facilitating activities of daily living. A front seat height adjustment feature on a new wheelchair prototype may be beneficial for transfers and conducting sustained low-to-the ground activities. End user evaluations can provide valuable insight to direct future design modifications and innovation.

Maternal and child patterns of Medicaid retention: a prospective cohort study.

BACKGROUND: We sought to determine whether maternal Medicaid retention influences child Medicaid retention because caregivers play a critical role in assuring children's health access. METHODS: We conducted a longitudinal prospective cohort study of a convenience sample of 604 Medicaid-eligible mother-child dyads followed from the infant's birth through 24 months of age with parent surveys. Individual enrollment status was abstracted from administrative Medicaid eligibility files. Generalized estimating equations quantified the effect of maternal Medicaid enrollment status on child Medicaid retention, adjusting for relevant covariates. Because varying lengths of gaps may have different effects on child health outcomes, Medicaid enrollment status was further categorized by length of gap: any gap, > 14-days, and > 60-days. RESULTS: This cohort consists primarily of African-American (94%), unmarried mothers (88%), with a mean age of 23.2 years. In multivariable analysis, children whose mothers experienced any gaps in coverage had 12.6 times greater odds of experiencing gaps when compared to children whose mothers were continuously enrolled. Use of varying thresholds to define coverage gaps resulted in similar odds ratios (> 14-day gap = 11.8, > 60-day gap = 16.8). Cash assistance receipt and maternal knowledge of differences between Temporary Assistance to Needy Families and Medicaid eligibility criteria demonstrated strong protective effects against child Medicaid disenrollment. CONCLUSIONS: Medicaid disenrollment remains a significant policy problem and maternal Medicaid retention patterns show strong effects on child Medicaid retention. Policymakers need to invest in effective outreach strategies, including family-friendly application processes, to reduce enrollment barriers so that all eligible families can take advantage of these coverage opportunities.

Do changes in socio-demographic characteristics impact up-to-date immunization status between 3 and 24 months of age? A prospective study among an inner-city birth cohort in the United States.

INTRODUCTION: Low-income child populations remain under-vaccinated. Our objective was to determine differences in the relative importance of maternal health literacy and socio-demographic characteristics that often change during early childhood on up-to-date (UTD) immunization status among a low-income population. METHODS: We performed secondary data analysis of a longitudinal prospective cohort study of 744 Medicaid-eligible mother-infant dyads recruited at the time of the infant's birth from an inner-city hospital in the United States and surveyed every 6 months for 24 months. Our primary outcome was infant UTD status at 24 months abstracted from a citywide registry. We assessed maternal health literacy with the Test of Functional Health Literacy in Adults (short version). We collected socio-demographic information via surveys at birth and every 6 months. We compared predictors of UTD status at 3, 7, and 24 months. RESULTS: The cohort consisted of primarily African-American (81.5%) mothers with adequate health literacy (73.9%). Immunizations were UTD among 56.7% of infants at 24 months of age. Maternal health literacy was not a significant predictor of UTD immunization status. Instead, adjusted results showed that significant predictors of not-UTD status at 24 months were lack of a consistent health care location or "medical home" (OR 0.17, 95%CI 0.18-0.37), inadequate prenatal care (OR 0.48, 95%CI 0.25-0.95), and prior not-UTD status (OR 0.31, 95%CI 0.20-0.47). Notably, all upper confidence limits are less than 1.0 for these variables. Health care location type (e.g., hospital-affiliate, community-based, none) was a significant predictor of vaccine status at age 3 months, 7 months, and 24 months. CONCLUSIONS: Investing in efforts to support early establishment of a medical home to obtain comprehensive coordinated preventive care, including providing recommended vaccines on schedule, is a prudent strategy to improve vaccination status at the population level.

User perceptions of existing home access solutions and a novel home access device.

PURPOSE: This study aimed to evaluate end user perspectives of four existing home access solutions (HAS) and a newly designed experimental device (the ARISE). METHOD: A cross-sectional design was used to evaluate the ARISE prototype against other HAS. Specifically, participants trialed stairs, a ramp, a platform lift (PL), a stair glide and the ARISE, after which they completed questionnaires aimed at soliciting their perspectives of these solutions. The time taken by participants to use each HAS was also collected. RESULTS: Five HAS design features were deemed as important by 90% of participants: ease of use, ability to use independently, reliability, safety and security. Time taken to use each HAS from fastest to slowest was: stairs, the ARISE, ramp, PL and stair glide. The ARISE prototype was rated as the first or second most preferred device by the most number of participants, followed by the PL, then the ramp. CONCLUSIONS: Results from this study provide greater understanding of user perspectives of HAS. End user feedback on a novel prototype device has provided valuable insight into its usability and function, which should not only guide future development of this device, but also provide direction for other innovations around home access. Implications for Rehabilitation It is anticipated that gaining a better understanding of strengths and weaknesses of home access solutions will: assist clinicians and end users in finding solutions that meet the individuals' needs. lead to the development of new or improved solutions that more closely address user needs. encourage further innovation in the area.

An enriched medical home intervention using community health workers improves adherence to immunization schedules.

IMPORTANCE: Disparities in childhood vaccination rates persist. OBJECTIVE: To evaluate the impact of an enriched medical home intervention using community health workers on improving immunization adherence among young children. DESIGN: The intervention group received home visits from trained community health workers to support families in adhering to recommended care while the comparison group received usual care (i.e. no home visits/reminders). Immunization history and socio-demographic data were collected using medical records and a validated questionnaire. The doubly robust estimation of risk difference, which combines weighting via propensity score and outcome regression model, was used to compare immunization adherence rates between two groups. SETTING: Primary care practices affiliated with a suburban tertiary care academic medical center serving a socioeconomically diverse population. PARTICIPANTS: The study sample included children ≤ 2 years of age at enrollment who crossed at least one age time point of 3, 7, 15, or 24 months during their 6 months post-enrollment period. MAIN OUTCOMES AND MEASURES: The primary outcome was age-specific immunization up-to-date status defined by CDC guidelines. The primary predictor was participation in the intervention. RESULTS: The analysis included 201 children in the usual care group and 110 children in the intervention group. The usual care and intervention groups were divided into subgroups of newborn and infant/toddler to account for prior immunization history. After adjusting for differences in group characteristics, we found a significant absolute increase in the up-to-date immunization likelihood for both newborns (20.9%, p=0.01) and infants/toddlers (16.8%, p=0.01) receiving the intervention when compared to their peers receiving usual clinical care. CONCLUSIONS AND RELEVANCE: Our findings demonstrate the positive impact of an enriched medical home intervention using community health worker home visitation on early childhood immunization up-to-date status. With further study, this model may provide a cost-effective approach to improving childhood vaccination rates, especially for vulnerable groups.

Healthcare utilization by obese and overweight children.

OBJECTIVE: To examine the relationship between childhood obesity and health care use in a large, nationally representative group of children with measured anthropometrics. STUDY DESIGN: Analysis of 5 combined National Health and Nutrition Survey datasets from 2001 to 2010. Unadjusted and adjusted logistic regression models assessed the relationship between health care use variables and weight status (overweight: body mass index 85th to <95th percentile for age and sex; obese: body mass index ≥95th percentile for age and sex) for children 2-18 years of age. RESULTS: Overweight and obese children are more likely to receive their routine medical care in an emergency department than a primary care setting (overweight OR 1.95; 95% CI 1.22-3.14 and obese OR 1.88; 95% CI 1.24-2.86) than their normal-weight peers. After we adjusted for relevant covariates, this finding persisted among overweight, but not obese, children. Other health care use variables were not significantly associated with weight status. CONCLUSION: Overweight children may be more likely to use the emergency department than primary care settings for routine medical care. Interventions to establish primary care medical homes for overweight children merit consideration.

Medicaid and CHIP retention among children in 12 states.

OBJECTIVE: Though stable insurance is important to support optimal child health, the reproducibility of metrics to assess child health insurance retention at the state and county level has not been examined. We sought to determine reproducibility of public insurance retention rates for children using 3 different metrics at the state and county level. METHODS: Public health insurance retention for children was assessed using 3 different metrics calculated from 2006-2009 Medicaid Analytic Extract data from 12 selected states. The metrics were: 1) Duration: a prospective metric that quantifies the number of newly enrolled children continuously enrolled in public insurance 6, 12, and 18 months after initial enrollment during a selected period; (2) Infant Duration: assesses Duration only among infants born during a selected period; (3) Coverage: a prospective metric that quantifies the average percentage of time a selected population is enrolled over an 18-month interval. Reproducibility of the metrics was assessed using a range of sample sizes with resampling and determining changes in relative rankings of states/counties by retention rate. RESULTS: All 3 metrics demonstrated reproducible estimates at the state level with sample sizes of 2000, 5000, and 10,000. Reproducibility of relative rankings for child health insurance retention of counties within states were sensitive to county child population size and the amount of variability in retention rates within the county and at the state level. CONCLUSIONS: As health care reform unfolds, the complete set of these 3 reproducible metrics can be used to evaluate multipronged and multilevel strategies to retain eligible children in public health insurance.

Biomechanical characteristics, patient preference and activity level with different prosthetic feet: a randomized double blind trial with laboratory and community testing.

Providing appropriate prosthetic feet to those with limb loss is a complex and subjective process influenced by professional judgment and payer guidelines. This study used a small load cell (Europa™) at the base of the socket to measure the sagittal moments during walking with three objective categories of prosthetic feet in eleven individuals with transtibial limb loss with MFCL K2, K3 and K4 functional levels. Forefoot stiffness and hysteresis characteristics defined the three foot categories: Stiff, Intermediate, and Compliant. Prosthetic feet were randomly assigned and blinded from participants and investigators. After laboratory testing, participants completed one week community wear tests followed by a modified prosthetics evaluation questionnaire to determine if a specific category of prosthetic feet was preferred. The Compliant category of prosthetic feet was preferred by the participants (P=0.025) over the Stiff and Intermediate prosthetic feet, and the Compliant and Intermediate feet had 15% lower maximum sagittal moments during walking in the laboratory (P=0.0011) compared to the Stiff feet. The activity level of the participants did not change significantly with any of the wear tests in the community, suggesting that each foot was evaluated over a similar number of steps, but did not inherently increase activity. This is the first randomized double blind study in which prosthetic users have expressed a preference for a specific biomechanical characteristic of prosthetic feet: those with lower peak sagittal moments were preferred, and specifically preferred on slopes, stairs, uneven terrain, and during turns and maneuvering during real world use.

The influence of maternal health literacy and child's age on participation in social welfare programs.

The objective of this study is to determine the influence of maternal health literacy and child's age on participation in social welfare programs benefiting children. In a longitudinal prospective cohort study of 560 Medicaid-eligible mother-infant dyads recruited in Philadelphia, maternal health literacy was assessed using the test of functional health literacy in adults (short version). Participation in social welfare programs [Temporary Assistance to Needy Families (TANF), Supplemental Nutrition Assistance Program (SNAP), Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), child care subsidy, and public housing] was self-reported at child's birth, and at the 6, 12, 18, 24 month follow-up interviews. Generalized estimating equations quantified the strength of maternal health literacy as an estimator of program participation. The mothers were primarily African-Americans (83%), single (87%), with multiple children (62%). Nearly 24% of the mothers had inadequate or marginal health literacy. Children whose mothers had inadequate health literacy were less likely to receive child care subsidy (adjusted OR = 0.54, 95% CI 0.34-0.85) than children whose mothers had adequate health literacy. Health literacy was not a significant predictor for TANF, SNAP, WIC or housing assistance. The predicted probability for participation in all programs decreased from birth to 24 months. Most notably, predicted WIC participation declined rapidly after age one. During the first 24 months, mothers with inadequate health literacy could benefit from simplified or facilitated child care subsidy application processes. Targeted outreach and enrollment efforts conducted by social welfare programs need to take into account the changing needs of families as children age.

Continuity of public insurance coverage: a systematic review of the literature.

Publicly financed insurance programs are tasked with maintaining coverage for eligible children, but published measures to assess coverage have not been evaluated. Therefore, we sought to identify and categorize measures of health insurance continuity for children and adolescents. We conducted a systematic review of Medline and HealthStar databases, review of reference lists of eligible articles, and contact with experts. We categorized measures into 8 domains based on a conceptual framework. We identified 147 measures from 84 eligible articles. Most measures evaluated the following domains: always insured (41%), repeatedly uninsured (36%), and transition out of coverage (29%), while fewer assessed single gap in coverage, always uninsured, transition into coverage, change in coverage, and eligibility. Only 18% of measures assessed associations between continuity of coverage and child and adolescent health outcomes. These results suggest that a number of measures of continuity of coverage exist, but few measures have assessed impact on outcomes.

Reading level of Medicaid renewal applications.

OBJECTIVE: To examine compliance of Medicaid-renewal applications to established state guidelines for reading level of Medicaid-related materials. METHODS: We assessed the reading level of the 2008 Medicaid renewal applications by using 3 readability tests: Flesch-Kincaid Grade Level Index, New Fog Count, and FORCAST. RESULTS: In 2008, 45 states and the District of Columbia had reading level guidelines for Medicaid-related materials. Of these, 24 (52.2%) states' Medicaid renewal applications failed to meet their guidelines on all 3 readability tests; in particular, 41 states (89.1%) failed the Flesch-Kincaid Grade Level Index. Only one state's application had a Flesch-Kincaid score below a 5th-grade reading level. CONCLUSIONS: As health care reform unfolds, complying with established reading level guidelines for Medicaid-related materials is one simplification strategy that should be implemented to improve access for Medicaid-eligible families and prevent eligible children from losing coverage unnecessarily.