Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure.

BACKGROUND: Digital health tools may improve quality of life (QoL) in patients with heart failure (HF) by promoting self-care, knowledge, and engagement. OBJECTIVES: This study evaluates the effect of 3 digital technologies on QoL in patients with HF. METHODS: A total of 182 patients were randomized to usual care or one of the technologies promoting self-care: Bodyport (cardiac scale), Conversa (conversational platform), or Noom (smartphone application). The primary outcome was 90-day change in QoL, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (OSS). RESULTS: A total of 151 participants (83%) completed their 90-day surveys. The median age of enrolled participants was 61 years (IQR: 53-69 years), and 37.9% were women. No group had any significant change in KCCQ OSS or improvement relative to usual care. However, symptoms and physical function at 90 days, as assessed by the Total Symptom Score (TSS) and Clinical Summary Score (CSS), were significantly improved in the Noom group relative to usual care: TSS median change of +4.2 points (IQR -1 to +16.7) vs -1 points (IQR: -13.5 to +7.8; P = 0.006); CSS median change of +2.8 points (IQR: -1 to +14.6) vs -3.1 points (IQR: -10.2 to +3; P = 0.002). CONCLUSIONS: Three digital interventions showed no independent effect on QoL as assessed by the KCCQ OSS. However, participants randomized to the Noom technology demonstrated improved KCCQ TSS and CSS relative to usual care. Although digital tools may be an important component of longitudinal care for patients with HF, larger studies are needed to better understand their effectiveness and optimal deployment. (Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure; NCT04394754).

Medical Marijuana for Pain Management in Hospice Care as a Complementary Approach to Scheduled Opioids: A Single Arm Study.

Background: Opioid therapy is critical for pain relief for most hospice patients but may be limited by adverse side effects. Combining medical cannabis with opioids may help mitigate adverse effects while maintaining effective pain relief. Aim: This single-arm study investigated the impact of combined medical cannabis/opioid therapy on pain relief, opioid dose, appetite, respiratory function, well-being, nausea, and adverse events in hospice inpatients. Design: Adult hospice inpatients using scheduled oral, parenteral, or transdermal opioids for pain were administered standardized oral medical cannabis, 40 mg CBD/1.5 mg THC or 80 mg CBD/3 mg THC. Descriptive statistics detailed demographic and clinical baseline characteristics, the Mann-Whitney test compared outcomes, and the longitudinal mixed effects regression model analyzed longitudinal effects of combined therapy. Setting/Participants: Sixty-six inpatients at The Connecticut Hospital, Inc. were assessed over 996 treatment days; average age was 68.2 ± 12.9 years, 90.9% were white. Cancer was the most common diagnosis. Results: The medical cannabis/opioid combination showed a significant longitudinal reduction in pain intensity (P = .0029) and a non-significant trend toward lower opioid doses. Well-being, appetite, nausea, and respiratory function showed non-statistically significant changes. Three patients (4.5%) experienced minor, reversible adverse events potentially related to medical cannabis. No serious or life-threatening adverse events were seen. Conclusion: Combination medical cannabis/opioid therapy showed statistically significant pain relief and may have the potential for reducing opioid dose and mitigating opioid toxicity, offering a safe pain management alternative to opioids alone for patients in end-of-life care settings, and warrants further investigation in larger controlled trials.

Machine learning identifies T cell receptor repertoire signatures associated with COVID-19 severity.

T cell receptor (TCR) repertoires are critical for antiviral immunity. Determining the TCR repertoire composition, diversity, and dynamics and how they change during viral infection can inform the molecular specificity of host responses to viruses such as SARS-CoV-2. To determine signatures associated with COVID-19 disease severity, here we perform a large-scale analysis of over 4.7 billion sequences across 2130 TCR repertoires from COVID-19 patients and healthy donors. TCR repertoire analyses from these data identify and characterize convergent COVID-19-associated CDR3 gene usages, specificity groups, and sequence patterns. Here we show that T cell clonal expansion is associated with the upregulation of T cell effector function, TCR signaling, NF-kB signaling, and interferon-gamma signaling pathways. We also demonstrate that machine learning approaches accurately predict COVID-19 infection based on TCR sequence features, with certain high-power models reaching near-perfect AUROC scores. These analyses provide a systems immunology view of T cell adaptive immune responses to COVID-19.

Genome Engineering for Next-Generation Cellular Immunotherapies.

Over the past decade, cellular immunotherapies such as CAR-T, TCR-T, and NK cell therapies have achieved tremendous success in cancer treatment. However, various challenges and obstacles remain, including antigen escape, immunosuppression in the tumor microenvironment, toxicities, and on-target off-tumor effects. Recent strategies for overcoming these roadblocks have included the use of genome engineering. Multiplexed CRISPR-Cas and synthetic biology approaches facilitate the development of cell therapies with higher potency and sophisticated modular control; they also offer a toolkit for allogeneic therapy development. Engineering approaches have targeted genetic modifications to enhance long-term persistence through cytokine modulation, knockout of genes mediating immunosuppressive signals, and genes such as the endogenous TCR and MHC-I that elicit adverse host-graft interactions in an allogeneic context. Genome engineering approaches for other immune cell types are also being explored, such as CAR macrophages and CAR-NK cells. Future therapeutic development of cellular immunotherapies may also be guided by novel target discovery through unbiased CRISPR genetic screening approaches.

Pragmatic randomized trial assessing the impact of digital health technology on quality of life in patients with heart failure: Design, rationale and implementation.

BACKGROUND: Self-care and patient engagement are important elements of heart failure (HF) care, endorsed in the guidelines. Digital health tools may improve quality of life (QOL) in HF patients by promoting care, knowledge, and engagement. This manuscript describes the rationale and challenges of the design and implementation of a pragmatic randomized controlled trial to evaluate the efficacy of three digital health technologies in improving QOL for patients with HF. HYPOTHESIS: We hypothesize that digital health interventions will improve QOL of HF patients through the early detection of warning signs of disease exacerbation, the opportunity of self-tracking symptoms, and the education provided, which enhances patient empowerment. METHODS: Using a fully electronic enrollment and consent platform, the trial will randomize 200 patients across HF clinics in the Yale New Haven Health system to receive either usual care or one of three digital technologies designed to promote self-management and provide critical data to clinicians. The primary outcome is the change in QOL as assessed by the Kansas City Cardiomyopathy Questionnaire at 3 months. RESULTS: First enrollment occurred in September 2021. Recruitment was anticipated to last 6-8 months and participants were followed for 6 months after randomization. Our recruitment efforts have highlighted the large digital divide in our population of interest. CONCLUSION: Assessing clinical outcomes, patient usability, and ease of clinical integration of digital technologies will be beneficial in determining the feasibility of the integration of such technologies into the healthcare system.

The Humanoid Robot Sil-Bot in a Cognitive Training Program for Community-Dwelling Elderly People with Mild Cognitive Impairment during the COVID-19 Pandemic: A Randomized Controlled Trial.

BACKGROUND: Mild cognitive impairment (MCI) is a stage preceding dementia, and early intervention is critical. This study investigated whether multi-domain cognitive training programs, especially robot-assisted training, conducted 12 times, twice a week for 6 weeks can improve cognitive function and depression decline in community-dwelling older adults with mild cognitive impairment (MCI). METHODS: A randomized controlled trial was conducted with 135 volunteers without cognitive impairment aged 60 years old or older. Participants were first randomized into two groups. One group consisted of 90 participants who would receive cognitive training and 45 who would not receive any training (NI). The cognitive training group was randomly divided into two groups, 45 who received traditional cognitive training (TCT) and 45 who received robot-assisted cognitive training (RACT). The training for both groups consisted of a daily 60 min session, twice a week for six weeks. RESULTS: RACT participants had significantly greater post-intervention improvement in cognitive function (t = 4.707, p < 0.001), memory (t = -2.282, p = 0.007), executive function (t = 4.610, p < 0.001), and depression (t = -3.307, p = 0.004). TCT participants had greater post-intervention improvement in memory (t = -6.671, p < 0.001) and executive function (t = 5.393, p < 0.001). CONCLUSIONS: A 6-week robot-assisted, multi-domain cognitive training program can improve the efficiency of global cognitive function and depression during cognitive tasks in older adults with MCI, which is associated with improvements in memory and executive function.

Korean Work Environment Scales for Clinical Nurses.

AIM: The aim of this study was to develop an assessment tool for the hospital nursing work environment in Korea. METHODS: The participants were 564 clinical nurses who worked in 13 hospitals in seven provinces in regions throughout South Korea; they worked in medical-surgical nursing, pediatric and maternal nursing, intensive care unit, and other areas. The data analysis relied on descriptive analysis and exploratory factor analysis, including varimax rotation, and reliability was determined using SPSS software. RESULTS: The final assessment tool, the Korean Work Environment Scales for Clinical Nurses (KWES-CN) was composed of 39 items divided into nine factors: (i) manager leadership; (ii) supporting environment for nursing work; (iii) patient care environment and professional activities; (iv) violence within ward; (v) sufficient inventory and supply; (vi) hospital's support for working environment; (vii) recognition and respect; (viii) satisfaction with work schedule; and (ix) computer problems. The total variance for validity described by the nine factors was 58.7% and the reliability of the tool was a Cronbach's alpha of 0.87. CONCLUSION: This final assessment tool will be used to improve nursing work. Further research must be conducted to verify the reliability and validity of this tool, and evaluations of nursing quality and patient results related to the nursing environment.

Aggressive angiomyxoma of the vulva: A case report.

Aggressive angiomyxoma (AA) is an unusual mesenchymal tumor. AA occurs most commonly in women of reproductive age and is located in the perineal or pelvic region. This is a distinct soft tissue tumor that has a prominent myxoid matrix and numerous thin-walled blood vessels and may have an aggressive local recurrence. The tumors have the characteristics of large size (usually greater than 10 cm) and slow growth, and are not painful. The standard treatment for AA is total excision and close follow-up. We announce a case of a 35 year-old female presenting with a pedunculated AA on the right labium majora that has not relapsed for seven years.

Angiomyofibroblastoma of the vulva.

Angiomyofibroblastoma (AMFB) is an uncommon benign mesenchymal tumor. AMFB occurs almost in the vulvo-vaginal area of women. The gross features of AMFB are well-circumscribed so it clinically is often thought as Bartholin gland cyst or aggressive angiomyxoma. Usually, most tumors grow slowly, and patients do not feel pain. It also has low tendency for local recurrence. The histologic findings of the tumors are abundant thin-walled blood vessels with hypocellular and hypercellular areas. Almost all tumor cells have immunoreactivity for both desmin and vimentin. It also has estrogen and/or progesterone receptors, but staining for cytokeratin is negative. Here is a case of AMFB of the vulva occurring in a 40-year-old woman, involving the right labia majora. The patient described that her vulva mass grew in about few months. The maximum dimension of the tumor was measured as 2 cm, and we resected the tumor one month after as her second visit.

[Structural equation modeling on nursing productivity of nurses in Korea].

PURPOSE: The purpose of this study was to propose and test a predictive model that could explain and predict nursing productivity. METHODS: A survey using a structured questionnaire was conducted with 360 nurses in Korea. The data were analyzed using SPSS Windows 18.0 and AMOS 19.0 program. RESULTS: Based on the constructed model, burnout and organizational commitment were found to have direct effects on nurses' turnover intention and nursing productivity. While nursing work environment was found to have indirect effects on nurses' turnover intention and nursing productivity. CONCLUSION: This structural equational model is a comprehensive theoretical model that explains the related factors and their relationship with nursing productivity. Comprehensive organizational interventions to improve nursing productivity should focus on improving the nursing work environment. Findings from this study can be used to design appropriate strategies to decrease nurse turnover in Korea. Further studies are needed to prospectively verify these causal relationships with larger samples.

Vaginal cancer with multiple liver and pulmonary metastases that achieved long-term survival.

Primary vaginal cancer represents only 1% to 2% of malignant neoplasm of the female genital tract. Here, we report a 68-year-old woman who showed a vaginal tumor extending to urethra and clitoris, a 10 cm-sized mass in left adnexa and multiple metastases in lung and liver. Vaginal biopsy showed squamous cell carcinoma of vagina and she was diagnosed as International Federation of Gynecology and Obstetrics stage IVB vaginal cancer. Palliative surgery including left salpingectomy, tumorectomy, and clitoris mass excision was performed. Concurrent chemoradiation therapy (CCRT) with six cycles of 5-fluorouracil and cisplatin was administered. The patient had a complete remission of 20 months after treatment. At a 40-month follow-up, there was no evidence of local recurrence or distant metastasis. We can suggest that CCRT is very effective in treating primary squamous cell carcinoma of the vagina, not only in locally advanced but also systemically involved vaginal cancer in selected cases.

Analysis of changes in the viability and gene expression profiles of human mesenchymal stromal cells over time.

BACKGROUND AIMS: Because of their ability to differentiate and widespread availability, human mesenchymal stromal cells (hMSC) are often used as a clinical therapeutic tool. However, the factors that determine the quality and viability of hMSC are not well understood. METHODS: We evaluated the viability of hMSC over time using flow cytometry analysis (FACS) and transmission electron microscopy (TEM) to determine if morphologic changes occurred in hMSC. In addition, we conducted gene expression prof ling using an Affymetrix Human Genome U133 Plus 2.0 Array. RESULTS: FACS analysis revealed that 83% and 76% of the cells were viable in sterilized phosphate-buffered saline (PBS) after 6 h and 12 h, respectively. TEM data revealed that the total number of cells with healthy chromatins or a few cytosolic vacuoles was significantly reduced over time. We then conducted gene expression profiling using a microarray, which revealed changes in the expression of 2949 functional genes. Specifically, among the total of 50,000 gene probes evaluated, the expression levels of apoptosis and stress-related genes were significantly increased over time. CONCLUSIONS: The results of this study suggest that the viability of hMSC decreases after disassociation from the culture dish and time is an essential factor when considering hMSC as a potential source for stem cell-based direct transplantation.