Effectiveness of the Complete Health Improvement Program in a Geriatric Population.

The Complete Health Improvement Program (CHIP) is an intensive therapeutic lifestyle modification program (ITLMP) with well-documented success in decreasing risk factors for cardiovascular disease (CVD). Plant-based diets and physical activity are components of the program that contribute to these improvements. Yet, there are few studies on how ITLMPs affect risk factors specifically for the geriatric population. The goal of this study was to examine results of CHIP participants with a focus on the older (greater than 65 years) population in Athens, Ohio. Retrospective data from 2011 to 2017 were analyzed for 26 CHIP classes. Recorded variables included body mass index (BMI), blood pressure (BP), total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), blood glucose (BG), and exercise level. Among geriatric participants, significant changes were found in BMI, BP, TC, LDL, HDL, BG, and exercise level (P < .001). As compared to the younger population, changes in variables were equivalent in the geriatric population in all variables (P > .05). These improvements in CVD risk factors among the elderly support the hypothesis that CHIP should be considered for CVD prevention and treatment in the geriatric population.

Comparison of the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children: an open-label, randomised, multicentre, non-inferiority, parallel-group, phase 3 trial.

Background: Considering the cholera menace in India and to seek licensure of the oral cholera vaccine (OCV), Euvichol-Plus, we conducted a clinical trial to compare the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children. Methods: This phase 3, open-label, multicentre, randomised, non-inferiority, parallel-group, comparative study was conducted at seven sites across India involving 416 healthy adults (aged ≥18-60 years) and children (aged ≥1 to <18 years). Healthy individuals who agreed to participate through a voluntary written informed consent form along with oral or written assent (for children aged 7-18 years) were included. No assent was required for those <7 years, as consent was given by the legally acceptable representatives (LAR). Participants were randomised 1:1 to receive two doses of either Euvichol-Plus or Shanchol orally, 14 days apart. The first dose (1.5 ml) was administered on visit 1, and the second dose at 2 weeks after the first dose during visit 2. Participants were followed up telephonically for 3 consecutive days after each visit and returned for final assessment at 2 weeks after the second dose (visit 3). Blood samples were collected for immunogenicity assessment, and safety analyses were done during all the visits. The primary immunogenicity endpoint was the percentage of participants with ≥4-fold increase in anti-Vibrio cholerae (V. cholerae) O1 Ogawa and O1 Inaba (vibriocidal) antibody titres at 2 weeks after the second dose as compared to baseline titres prior to dosing. The secondary immunogenicity endpoints included the percentage of participants with ≥4-fold increase in anti-V. cholerae O139 antibody titres at 2 weeks after the second dose as compared to baseline titres, and geometric mean titres (GMT) and geometric mean ratios (GMR) as measured by anti-V. cholerae O1 Ogawa, O1 Inaba, and O139 antibody titres at 2 weeks after the second dose as compared to baseline titres. The safety endpoints included assessment of solicited, unsolicited adverse events (AEs), and serious adverse events (SAEs). The clinical trial was registered with the Clinical Trials Registry of India (CTRI/2021/08/035344). Findings: The study was performed in two age cohorts: cohort 1 (aged ≥18-60 years, 208 participants [104 in Euvichol-Plus group and 104 in Shanchol group]), and cohort 2 (aged ≥1 to <18 years, 208 participants [104 in Euvichol-Plus group and 104 in Shanchol group]). A total of 414 participants (Euvichol-Plus: 206 and Shanchol: 208) who completed the study (intention-to-treat and per-protocol set) were analysed to compare the vibriocidal titre as an index for immunogenicity. At 2 weeks after the second dose, the percentage of participants in the Euvichol-Plus group who reported a ≥4-fold increase in anti-V. cholerae antibody titres were 68.93% (O1 Ogawa) [95% CI 62.13%-75.18%], 66.02% (O1 Inaba) [95% CI 59.11%-72.46%], and 59.71% (O139) [95% CI 52.67%-66.47%] as compared to 63.94% (O1 Ogawa) [95% CI 57.01%-70.47%], 65.87% (O1 Inaba) [95% CI 58.99%-72.28%], and 56.25% (O139) [95% CI 49.22%-63.10%] in the Shanchol group. The lower limit of 95% CI for treatment difference for all the antibody titres was ≥10% (non-inferiority margin), demonstrating that Euvichol-Plus was non-inferior to Shanchol. The post-vaccination GMT (Day 14 and 28) were more than the pre-vaccination GMT for all three serotypes in both groups. The GMR obtained for Euvichol-Plus over Shanchol for O1 Ogawa, O1 Inaba, and O139 serotypes was >1, indicating non-inferiority of Euvichol-Plus to Shanchol. The safety cohort included 416 participants. Headache was the most common solicited AE, whereas cold and cough were the most common unsolicited AEs in both groups. Interpretation: Euvichol-Plus appears to be non-inferior to Shanchol in terms of immunogenicity and safety in healthy Indian adults and children. Funding: Techinvention Lifecare Private Limited, Mumbai, India.

Beyond antibiotics: phage-encoded lysins against Gram-negative pathogens.

Antibiotics remain the frontline agents for treating deadly bacterial pathogens. However, the indiscriminate use of these valuable agents has led to an alarming rise in AMR. The antibiotic pipeline is insufficient to tackle the AMR threat, especially with respect to the WHO critical category of priority Gram-negative pathogens, which have become a serious problem as nosocomial and community infections and pose a threat globally. The AMR pandemic requires solutions that provide novel antibacterial agents that are not only effective but against which bacteria are less likely to gain resistance. In this regard, natural or engineered phage-encoded lysins (enzybiotics) armed with numerous features represent an attractive alternative to the currently available antibiotics. Several lysins have exhibited promising efficacy and safety against Gram-positive pathogens, with some in late stages of clinical development and some commercially available. However, in the case of Gram-negative bacteria, the outer membrane acts as a formidable barrier; hence, lysins are often used in combination with OMPs or engineered to overcome the outer membrane barrier. In this review, we have briefly explained AMR and the initiatives taken by different organizations globally to tackle the AMR threat at different levels. We bring forth the promising potential and challenges of lysins, focusing on the WHO critical category of priority Gram-negative bacteria and lysins under investigation for these pathogens, along with the challenges associated with developing them as therapeutics within the existing regulatory framework.

The association between COVID-19 preventive behaviors and mental health conditions.

BACKGROUND: An unintended consequence of COVID-19 quarantine preventive measures, is the increased prevalence of anxiety and depression. The purpose of this study was to examine the association between COVID-19 preventive behaviors and mental health conditions. METHODS: A cross-sectional study was conducted using secondary data collected weekly from US adults aged 18 and older nationwide as part of the COVID-19 Household Impact Survey (CIS) from the University of Chicago. Logistic regression examined associations between COVID-19 preventive behaviors (wearing a face mask, washing or sanitizing hands, and keeping six-feet distance from those outside their household), mental health conditions (self-reporting feeling nervous, anxious, or on edge, feeling lonely, and feeling hopeless about the future and a history of a mental health condition) and demographic factors. RESULTS: Majority of study participants were under 60 years (62.2%), female (55.8%), and non-Hispanic White (72.2%). Overall, participants more likely to have followed all three COVID-19 measures were those who reported high psychological distress compared to those with low distress for feeling anxious (adj. OR 1.16, 95% CI: 1.06-1.28, p = 0.002), lonely (adj. OR 1.12, 95% CI: 1.02-1.23, p = 0.019) or hopeless (adj. OR 1.10, 95% CI: 1.00-1.21, p = 0.043) for more than a day during the past 7 days. CONCLUSION: Our findings highlight that individuals with mental health conditions reported more psychological distress. Specifically, feeling depressed, anxious, lonely, and hopeless were triggered and exacerbated as a result of the pandemic and may have long-term effects on general well-being and productivity. Therefore, our findings have important implications on the need to include mental health promotion as part of pandemic response efforts. This includes developing policies and allocating funding so as to ensure sustainable mental health interventions and support, public and provider education on the importance of screening for mental health issues.

Factors Influencing COVID-19 Prevention Behaviors.

COVID-19 remains a public health emergency with prevention guidelines and mitigation strategies being constantly updated to curb the rapid spread of the disease. Despite proven successes of recommended preventive behaviors, there is low uptake of wearing a mask, washing of hands, and social distancing in the United States (US). The purpose of this study was to examine factors that influence COVID-19 preventive behaviors. We used data from the nationally representative COVID-19 Household Impact Survey (n = 19,815) conducted in the US from April to June 2020. Chi-square (χ2) test and bivariate analyses were performed to compare study participants who used all COVID-19 related preventive behaviors and those who did not, and multivariate logistic regressions to determine associations across demographic and social characteristics. Of the 19,815 participants, 79.2% of participants reported practicing the aforementioned COVID-19 preventive behaviors. Further, non-Hispanic white, Spanish speaking, living in urban areas, of older age (60+), being female, having an education above an undergraduate, those with income levels $100K or more, living in the urban northeast region that trust and communicate frequently with family and neighbors were more likely to use all three preventive behaviors. Findings suggest a need for continued provision of information on prevention and vaccination importance, but expand efforts to target adopters of these behaviors and encourage them to share their uptake and adherence efforts. This type of horizontal communication where information is shared within trusted social networks can shape social norms that influence the uptake of COVID-19 preventive behaviors and slowly curb communal spread.

The Impact of the Fascia Iliaca Block Beyond Perioperative Pain Control in Hip Fractures: A Retrospective Review.

Background: Geriatric hip fractures are common injuries that are associated with high morbidity and mortality. Adequate pain control remains a challenge as the altered physiology in elderly patients makes use of traditional analgesics challenging. The use of regional anesthetics, specifically the fascia iliaca compartment block (FICB), in the perioperative period has been shown to decrease opioid use in this population. This study aimed to investigate the effect the FICB had on pain control, length of stay, readmissions, and complications in a 30-day postoperative period. Methods: This was a retrospective cohort study comparing patients who sustained hip fractures; one cohort (110 patients) received a preoperative fascia iliaca block with continuous infusion (FICB), whereas the other cohort (110 patients) did not receive a block (NO-FICB). Both cohorts were from level II trauma centers. Data were collected between 2016 and 2019. Descriptive statistics was performed to describe and summarize the data. Bivariate analysis was performed using chi-square test, with 2 tailed P-values ≤ .05 were considered statistically significant. Results: The FICB group had a lower length of stay (3.9 days vs 4.8 days; P < .001), and lower pain scores on post-operative days 2 and 3 (P = .019). There was no difference in time from admission to surgery (P = .112) or narcotic use between cohorts (P = .304). However, the FICB group was more likely to discharge to a skilled nursing facility (P=.002), and more likely to be readmitted within 30 days (P = .047). There were no differences in medical complications or mortality between the 2 groups. Conclusions: The primary study endpoint, length of stay, was found to be significantly shorter in the patients who underwent the FICB vs the group who did not undergo the FICB. Pain scores on POD2 and POD3 were lower in patients who received a FICB. This study adds to the body of evidence that the FICB is an effective addition to a multimodal pain pathway. Level of Evidence: Level III Evidence - Retrospective Cohort Study.

Association between serum zinc levels and basic physical functioning: secondary data analysis of NHANES 2011-14.

BACKGROUND: Serum zinc (Zn) levels have been shown to be associated with functional status; however, it is not clear whether this association differs by other sociodemographic characteristics. We examined the association between serum Zn levels and physical functioning difficulty in a representative sample of older adults in the US. DESIGN AND METHODS: A cross-sectional study was conducted on participants 50 years and older from the 2011-12 and 2013-14 National Health and Nutrition Examination Surveys (n = 1136). Serum Zn levels were analyzed as tertiles. The main outcome of interest was physical functioning difficulty, defined as self-reported difficulty of basic physical functioning that included walking, transferring, dressing, and feeding. RESULTS: Mean Zn levels (SE) were 0.67(0.1), 0.81(0.1), and 0.98(0.1) µg/mL in the low, middle, and high Zn groups, respectively. Approximately 24.9% participants reported physical functioning difficulty. In the multivariable model, we found a significant multiplicative interaction between sex and serum Zn (P for interaction =0.028) and between education and serum Zn (P for interaction = 0.001) on basic physical functioning difficulty. The stratified analysis revealed that among men, compared to those with low serum Zn, the odds of having physical functioning difficulty were lower in men who had high serum Zn [aOR 0.43 (95% CI: 0.25-0.76)]. For women, compared to those with low serum Zn the odds of having physical functioning difficulty were higher in women who had middle serum Zn [aOR 2.67 (1.58-4.50)]. Among individuals with less than high school education, the odds of having physical functioning difficulty were lower in those who had middle serum Zn compared to those who had low serum Zn [aOR 0.48 (0.26-0.89)]. However, the odds of having physical functioning difficulty were higher in those who had middle serum Zn compared to those who had low serum Zn for individuals with high school [aOR 5.72 (1.92-17.00)] and beyond high school education [aOR 1.77 (1.05-2.97)], respectively. CONCLUSION: Sex and educational attainment interact with serum Zn levels to influence basic physical functioning difficulty in older adults.

Retrospective Evaluation of an Online Diabetes Health Coaching Program: A Pilot Study.

An estimated one third of American adults have prediabetes; over 30 million have type 2 diabetes mellitus. Health and wellness coaching is an emerging tool for preventing and treating chronic disease. Mastering Diabetes (MD) promotes a low-fat, plant-based, whole-food diet, utilizing online education, day-to-day accountability and support, and video conferencing. This pilot study provides a retrospective view of the effectiveness of MD to treat diabetes. Current and former clients of MD were invited to participate in a survey. On completion of the online consent, subjects were asked a series of questions in a REDCap-based survey: age, gender, enrollment date in MD, changes in weight, HbA1c, medication use, overall health, and current level of adherence to achieved changes. Overall, 253 (8.9%) participants responded to the survey; 80.6% were females, mean age was 56 years. Most of those responding (78.4%, P < .001) reported weight loss; 68.8% (P < .001) reported decreased HbA1c; 52.4% reported decreased medication use; 86.8% reported continued health improvement since having participated in MD; and 83.5% found the online program very helpful. This study demonstrated improvement in HbA1c and weight in participants in an online health and wellness coaching. Study limitations prevent drawing generalizable conclusions; further prospective evaluation is needed.

The benefit of negative pressure dressings in vascular surgery patients with infrainguinal incisions.

OBJECTIVE: Within the vascular patient population, there is an increased risk of developing wound complications especially in infrainguinal incisions. There has been increasing interest in using closed incisional negative pressure dressings to decrease the risk of wound complications. To assess the efficacy of these incisional wound dressings, we studied surgical site infections (SSI) and seroma rates of infrainguinal incisions in our vascular patient population. METHODS: This was a multi-institutional, retrospective study from July 2015 to June 2019. In 2017, our institution began using the Prevena incisional wound system. Wound complication rates were compared with the non-Prevena group before 2017. There were a total of 100 infrainguinal incisions (left and right combined) that received the Prevena wound system and 138 infrainguinal incisions that had not. The primary end point was to assess for wound complication rates, including SSIs and seroma formation. SSIs were graded based on the American College of Surgeons National Surgical Quality Improvement Plan SSI criteria. Seroma formation was diagnosed based on clinical diagnosis, imaging studies (ultrasound examination, computed tomography scan) or needle aspiration of fluid collection. RESULTS: This analysis showed a statistically significant decrease in the rate of SSIs in the Prevena group when compared with the non-Prevena group (P = .012). There was no statistical difference between the two groups in the rate of seroma formation (P = .155). Of the 100 incisions that received the Prevena wound system, 1.2% (1/82) had a femoral SSI and 22.0% (4/18) had a popliteal SSI. For seroma formation, 24.4% (20/82) had a femoral seroma and 11.1% (2/18) had a popliteal seroma. Of the 138 incisions that did not have the Prevena wound system, 9.6% (10/104) had a femoral SSI and 8.8% (3/34) had a popliteal SSI. For seroma formation, 24.0% (25/104) had a femoral seroma and 8.8% (3/34) had a popliteal seroma. Comorbid conditions were assessed in the two study groups and there was no statistical significance regarding rates of SSIs between the groups. CONCLUSIONS: The use of an incisional negative pressure dressing decreases the rate of SSIs in infrainguinal incisions. Regarding the use of these wound systems for seromas, our study did not show a statistically significant decrease in seroma rates.