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JMIR Formative Research Jun 2024Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the...
BACKGROUND
Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale.
OBJECTIVE
The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success.
METHODS
This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis.
RESULTS
Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated.
CONCLUSIONS
This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.
PubMed: 38935967
DOI: 10.2196/58551 -
JMIR MHealth and UHealth Jun 2024Rising rates of psychological distress (symptoms of depression, anxiety, and stress) among adults in the United States necessitate effective mental wellness...
BACKGROUND
Rising rates of psychological distress (symptoms of depression, anxiety, and stress) among adults in the United States necessitate effective mental wellness interventions. Despite the prevalence of smartphone app-based programs, research on their efficacy is limited, with only 14% showing clinically validated evidence. Our study evaluates Noom Mood, a commercially available smartphone-based app that uses cognitive behavioral therapy and mindfulness-based programming. In this study, we address gaps in the existing literature by examining postintervention outcomes and the broader impact on mental wellness.
OBJECTIVE
Noom Mood is a smartphone-based mental wellness program designed to be used by the general population. This prospective study evaluates the efficacy and postintervention outcomes of Noom Mood. We aim to address the rising psychological distress among adults in the United States.
METHODS
A 1-arm study design was used, with participants having access to the Noom Mood program for 16 weeks (N=273). Surveys were conducted at baseline, week 4, week 8, week 12, week 16, and week 32 (16 weeks' postprogram follow-up). This study assessed a range of mental health outcomes, including anxiety symptoms, depressive symptoms, perceived stress, well-being, quality of life, coping, emotion regulation, sleep, and workplace productivity (absenteeism or presenteeism).
RESULTS
The mean age of participants was 40.5 (SD 11.7) years. Statistically significant improvements in anxiety symptoms, depressive symptoms, and perceived stress were observed by week 4 and maintained through the 16-week intervention and the 32-week follow-up. The largest changes were observed in the first 4 weeks (29% lower, 25% lower, and 15% lower for anxiety symptoms, depressive symptoms, and perceived stress, respectively), and only small improvements were observed afterward. Reductions in clinically relevant anxiety (7-item generalized anxiety disorder scale) and depression (8-item Patient Health Questionnaire depression scale) criteria were also maintained from program initiation through the 16-week intervention and the 32-week follow-up. Work productivity also showed statistically significant results, with participants gaining 2.57 productive work days from baseline at 16 weeks, and remaining relatively stable (2.23 productive work days gained) at follow-up (32 weeks). Additionally, effects across all coping, sleep disturbance (23% lower at 32 weeks), and emotion dysregulation variables exhibited positive and significant trends at all time points (15% higher, 23% lower, and 25% higher respectively at 32 weeks).
CONCLUSIONS
This study contributes insights into the promising positive impact of Noom Mood on mental health and well-being outcomes, extending beyond the intervention phase. Though more rigorous studies are necessary to understand the mechanism of action at play, this exploratory study addresses critical gaps in the literature, highlighting the potential of smartphone-based mental wellness programs to lessen barriers to mental health support and improve diverse dimensions of well-being. Future research should explore the scalability, feasibility, and long-term adherence of such interventions across diverse populations.
Topics: Humans; Prospective Studies; Male; Female; Adult; Middle Aged; Surveys and Questionnaires; Mobile Applications; Health Promotion; Cognitive Behavioral Therapy; Program Evaluation; United States; Mindfulness; Quality of Life
PubMed: 38935946
DOI: 10.2196/54634 -
PloS One 2024At some point in their career, many healthcare workers will experience psychological distress associated with being unable to take morally or ethically correct action,...
OBJECTIVE
At some point in their career, many healthcare workers will experience psychological distress associated with being unable to take morally or ethically correct action, as it aligns with their own values; a phenomenon known as moral distress. Similarly, there are increasing reports of healthcare workers experiencing long-term mental and psychological pain, alongside internal dissonance, known as moral injury. This review examined the triggers and factors associated with moral distress and injury in Health and Social Care Workers (HSCW) employed across a range of clinical settings with the aim of understanding how to mitigate the effects of moral distress and identify potential preventative interventions.
METHODS
A systematic review was conducted and reported according to recommendations from Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Searches were conducted and updated regularly until January 2024 on 2 main databases (CENTRAL, PubMed) and three specialist databases (Scopus, CINAHL, PsycArticles), alongside hand searches of study registration databases and other systematic reviews reference lists. Eligible studies included a HSCW sample, explored moral distress/injury as a main aim, and were written in English or Italian. Verbatim quotes were extracted, and article quality was assessed via the CASP toolkit. Thematic analysis was conducted to identify patterns and arrange codes into themes. Specific factors like culture and diversity were explored, and the effects of exceptional circumstances like the pandemic.
RESULTS
Fifty-one reports of 49 studies were included in the review. Causes and triggers were categorised under three domains: individual, social, and organisational. At the individual level, patients' care options, professionals' beliefs, locus of control, task planning, and the ability to make decisions based on experience, were indicated as elements that can cause or trigger moral distress. In addition, and relevant to the CoVID-19 pandemic, was use/access to personal protection resources. The social or relational factors were linked to the responsibility for advocating for and communication with patients and families, and professionals own support network. At organisational levels, hierarchy, regulations, support, workload, culture, and resources (staff and equipment) were identified as elements that can affect professionals' moral comfort. Patients' care, morals/beliefs/standards, advocacy role and culture of context were the most referenced elements. Data on cultural differences and diversity were not sufficient to make assumptions. Lack of resources and rapid policy changes have emerged as key triggers related to the pandemic. This suggests that those responsible for policy decisions should be mindful of the potential impact on staff of sudden and top-down change.
CONCLUSION
This review indicates that causes and triggers of moral injury are multifactorial and largely influenced by the context and constraints within which professionals work. Moral distress is linked to the duty and responsibility of care, and professionals' disposition to prioritise the wellbeing of patients. If the organisational values and regulations are in contrast with individuals' beliefs, repercussions on professionals' wellbeing and retention are to be expected. Organisational strategies to mitigate against moral distress, or the longer-term sequalae of moral injury, should address the individual, social, and organisational elements identified in this review.
Topics: Humans; Health Personnel; Morals; Social Workers; Qualitative Research; COVID-19; Psychological Distress; Stress, Psychological
PubMed: 38935754
DOI: 10.1371/journal.pone.0303013 -
PloS One 2024To investigate the therapeutic effect and mechanism of sivelestat sodium on acute lung injury (AIL).
OBJECTIVE
To investigate the therapeutic effect and mechanism of sivelestat sodium on acute lung injury (AIL).
METHODS
A rat model for ALI/acute respiratory distress syndrome (ALI/ARDS) was established. Pathological examination of lung tissue was conducted to assess lung injury. Blood gas in the arteries was measured using a blood analyzer. Changes in PaO2, PaO2/FiO2, and lung wet/dry (W/D) weight ratio were carefully compared. ELISA assay was conducted to estimate cell adhesion and inflammation response. Finally, real-time reverse transcription polymerase chain reaction and western blotting assay was used to determine the activation of PI3K/AKT/mTOR pathway.
RESULTS
ARDS in vivo model was successfully constructed by LPS injection. Compared with the sham group, PaO2 and PaO2/FiO2 were significantly lower in the vehicle group, while the lung W/D ratio, the lung injury score, NE, VCAM-1, IL-8 andTNF-αwere significantly increased. After treatment with different doses of sivelestat sodium, we found PaO2, PaO2/FiO2 were prominently increased, while the lung W/D ratio, the lung injury score, NE, VCAM-1, IL-8, TNF-α levels were decreased in the dose-dependent manner. Meanwhile, compared with the vehicle group, the expression levels of Bax, PI3K, Akt and mTOR were significantly lower, and the expression of Bcl-2 was significantly higher after injection with sivelestat sodium.
CONCLUSION
Sivelestat sodium has an interventional effect on ALI in sepsis by inhibiting the PI3K/AKT/mTOR signalling pathway.
Topics: Animals; TOR Serine-Threonine Kinases; Acute Lung Injury; Signal Transduction; Proto-Oncogene Proteins c-akt; Phosphatidylinositol 3-Kinases; Rats; Male; Glycine; Sulfonamides; Rats, Sprague-Dawley; Lung; Disease Models, Animal
PubMed: 38935660
DOI: 10.1371/journal.pone.0302721 -
Critical Care Explorations Jul 2024To identify triggering receptor expressed in myeloid cells-like transcript-1 positive (TLT-1+) microparticles (MPs) and evaluate if their presence is associated with...
High Levels of Triggering Receptor Expressed in Myeloid Cells-Like Transcript-1 Positive, but Not Glycoprotein 1b+, Microparticles Are Associated With Poor Outcomes in Acute Respiratory Distress Syndrome.
OBJECTIVES
To identify triggering receptor expressed in myeloid cells-like transcript-1 positive (TLT-1+) microparticles (MPs) and evaluate if their presence is associated with clinical outcomes and/or disease severity in acute respiratory distress syndrome (ARDS).
DESIGN
Retrospective cohort study.
SETTING
ARDS Network clinical trials.
PATIENTS
A total of 564 patients were diagnosed with ARDS.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
Using flow cytometry, we demonstrated the presence of TLT-1+ platelet-derived microparticles (PMP) that bind fibrinogen in plasma samples from fresh donors. We retrospectively quantified TLT-1, glycoprotein (Gp) 1b, or αIIbβIIIa immunopositive microparticles in plasma samples from patients with ARDS enrolled in the ARMA, KARMA, and LARMA (Studies 01 and 03 lower versus higher tidal volume, ketoconazole treatment, and lisofylline treatment Clincial Trials) ARDS Network clinical trials and evaluated the relationship between these measures and clinical outcomes. No associations were found between Gp1b+ MPs and clinical outcomes for any of the cohorts. When stratified by quartile, associations were found for survival, ventilation-free breathing, and thrombocytopenia with αIIbβIIIa+ and TLT-1+ MPs (χ2p < 0.001). Notably, 63 of 64 patients in this study who failed to achieve unassisted breathing had TLT+ PMP in the 75th percentile. In all three cohorts, patients whose TLT+ MP counts were higher than the median had higher Acute Physiology and Chronic Health Evaluation III scores, were more likely to present with thrombocytopenia and were 3.7 times (p < 0.001) more likely to die than patients with lower TLT+ PMP after adjusting for other risk factors.
CONCLUSIONS
Although both αIIbβIIIa+ and TLT+ microparticles (αIIbβIIIa, TLT-1) were associated with mortality, TLT-1+ MPs demonstrated stronger correlations with Acute Physiology and Chronic Health Evaluation III scores, unassisted breathing, and multiple system organ failure. These findings warrant further exploration of the mechanistic role of TLT-1+ PMP in ARDS or acute lung injury progression.
Topics: Humans; Respiratory Distress Syndrome; Male; Female; Retrospective Studies; Middle Aged; Cell-Derived Microparticles; Adult; Membrane Glycoproteins; Aged; Cohort Studies; Platelet Glycoprotein GPIb-IX Complex; Flow Cytometry; Receptors, Immunologic
PubMed: 38935146
DOI: 10.1097/CCE.0000000000001108 -
Journal of Comparative Effectiveness... Jun 2024This is a summary of findings from two research studies (known as clinical trials). The studies looked at how well a medicine called relugolix combination therapy worked... (Review)
Review
WHAT IS THIS SUMMARY ABOUT?
This is a summary of findings from two research studies (known as clinical trials). The studies looked at how well a medicine called relugolix combination therapy worked in women with heavy menstrual bleeding (heavy bleeding during a period) with uterine fibroids (noncancerous or benign growths in the uterus). In this analysis of the studies, researchers looked at how patients self-reported their uterine fibroid symptoms before and after taking relugolix combination therapy. Researchers also looked at how patients self-reported the impact of uterine fibroids on their health-related quality of life before and after taking relugolix combination therapy.
WHAT WERE THE RESULTS?
Women took either relugolix combination therapy or placebo (a pill that contains no medicine) by mouth once daily for 24 weeks. Women completed the Uterine Fibroid Symptom and Quality of Life questionnaire (where "quality of life" refers to the women's health-related quality of life related to uterine fibroids) before, during, and after treatment. The questionnaire let researchers see if the women felt that relugolix combination therapy decreased the burden of uterine fibroid symptoms and improved the women's health-related quality of life related to uterine fibroids. More women said that they felt less distress due to their uterine fibroid symptoms and that their health-related quality of life related to uterine fibroids was better after taking relugolix combination therapy compared with women who took placebo.
WHAT DO THE RESULTS MEAN?
Relugolix combination therapy may lessen distress associated with uterine fibroid symptoms and improve health-related quality of life related to uterine fibroids.
PubMed: 38934918
DOI: 10.57264/cer-2023-0194 -
Indian Journal of Public Health Oct 2023Yuva Spandana (YS) is a unique community-based youth mental health promotion program implemented across Karnataka.
BACKGROUND
Yuva Spandana (YS) is a unique community-based youth mental health promotion program implemented across Karnataka.
OBJECTIVE
We assessed factors affecting PD among the population served by YS between January 1, 2017, and December 31, 2021.
MATERIALS AND METHODS
A retrospective cross-sectional analysis was done utilizing the visit forms of 10,340 YS's care recipients. A conceptual framework was developed, and all hypothesized variables within this framework were considered exposures. All exposure variables significant at P < 0.10 in univariate analysis were included in multivariable analysis. Multivariable logistic regression analysis was performed by including each of the significant potential exposure variables from univariate analysis using a forward-stepping process.
RESULTS
Care recipients with health and lifestyle issues were at almost two times increased risk for PD (adjusted odds ratio [AOR] =1.74 and 95% confidence interval [CI] - 1.52-2.00), and those with self-development issues were almost 2.5 times more likely to have PD (AOR = 2.44 and 95% CI - 2.12-2.79). Those who reported emotional statuses of feeling worried, lost, incapable, lonely, and distrusting were at 21.4, 3.5, 26.3, 37.9, and 4.7 times higher odds of having PD, respectively.
CONCLUSIONS
Isolating the risk factors associated with PD will help tailor the mental health promotion provided by YS to at-risk groups.
Topics: Humans; India; Cross-Sectional Studies; Male; Female; Adolescent; Retrospective Studies; Psychological Distress; Health Promotion; Child; Risk Factors; Socioeconomic Factors
PubMed: 38934826
DOI: 10.4103/ijph.ijph_1010_22 -
Indian Journal of Dental Research :... Jan 2024Internet Addiction and phubbing are prevalent disruptive behaviours among students. The aim of this study was to assess the relationship between phubbing, smartphone...
BACKGROUND
Internet Addiction and phubbing are prevalent disruptive behaviours among students. The aim of this study was to assess the relationship between phubbing, smartphone addiction and some of the related psychological effects among dental undergraduates.
MATERIALS AND METHODS
A multi-centric cross-sectional pre-validated questionnaire-based study was conducted among undergraduate students of five different dental colleges across India. The questionnaire included the Phubbing Scale, Barratt Impulsiveness Scale (BIS), Smartphone Application-based Addiction Scale (SABAS), and Rosenberg Self-Esteem Scale (RSES). The data were analysed with IBM SPSS version 21, followed by a t-test, analysis of variance (ANOVA), and Spearmen's co-relation to find the association between different psychological variables among study subjects.
RESULTS
The total sample comprise of 1226 with mean age of 22.35. The SABAS showed a higher mean ± standard deviation (SD) score (3.17 ± 0.93). The Phubbing Scale showed a positive correlation with the SABAS (0.658), the results were found to be highly statistically significant (P = 0.01).
CONCLUSION
The present study found a higher prevalence of phubbing and smartphone addiction among dental students. Our results showed that impulsiveness leads to internet addiction and thus phubbing is becoming a way to find solace during communication to escape anxiety and distress.
Topics: Humans; Students, Dental; Smartphone; Female; Cross-Sectional Studies; Male; Young Adult; Behavior, Addictive; India; Surveys and Questionnaires; Internet Addiction Disorder; Adult; Self Concept; Prevalence; Adolescent
PubMed: 38934742
DOI: 10.4103/ijdr.ijdr_565_23 -
Therapeutics and Clinical Risk... 2024Incorporating unfamiliar therapies into practice requires effective longitudinal learning and the optimal way to achieve this is debated. Though not a novel therapy,...
BACKGROUND
Incorporating unfamiliar therapies into practice requires effective longitudinal learning and the optimal way to achieve this is debated. Though not a novel therapy, ketamine in critical care has a paucity of data and variable acceptance, with limited research describing intensivist perceptions and utilization. The Coronavirus-19 pandemic presented a particular crisis where providers rapidly adapted analgosedation strategies to achieve prolonged, deep sedation due to a surge of severe acute respiratory distress syndrome (ARDS).
QUESTION
How does clinical experience with ketamine impact the perception and attitude of clinicians toward this therapy?
METHODS
We conducted a mixed-methods study using quantitative ketamine prescription data and qualitative focus group data. We analyzed prescription patterns of ketamine in a tertiary academic ICU during two different time points: pre-COVID-19 (March 1-June 30, 2019) and during the COVID-19 surge (March 1-June 30, 2020). Two focus groups (FG) of critical care attendings were held, and data were analyzed using the Framework Method for content analysis.
RESULTS
Four-hundred forty-six medical ICU patients were mechanically ventilated (195 pre-COVID-19 and 251 during COVID-19). The COVID-19 population was more likely to receive ketamine (81[32.3%] vs 4 [2.1%], p < 0.001). Thirteen respondents participated across two FG sessions (Pre-COVID = 8, Post-COVID=5). The most prevalent attitude among our respondents was discomfort, with three key themes identified as follows: 1) lack of evidence regarding ketamine, 2) lack of personal experience, and 3) desire for more education and protocols.
CONCLUSION
Despite a substantial increase in ketamine prescription during COVID-19, intensivists continued to feel discomfort with utilization. Factors contributing to this discomfort include a lack of evidence, a lack of experience, and a desire for more education and protocols. Increase in experience with ketamine alone was not sufficient to minimize provider discomfort. These findings should inform future curricula and call for process improvement to optimize continuing education.
PubMed: 38934016
DOI: 10.2147/TCRM.S462760 -
Vaccine: X Aug 2024Comirnaty, Pfizer-BioNTech's polyethylene-glycol (PEG)-containing Covid-19 vaccine, can cause hypersensitivity reactions (HSRs), or rarely, life-threatening anaphylaxis...
BACKGROUND
Comirnaty, Pfizer-BioNTech's polyethylene-glycol (PEG)-containing Covid-19 vaccine, can cause hypersensitivity reactions (HSRs), or rarely, life-threatening anaphylaxis in a small fraction of immunized people. A causal role of anti-PEG antibodies (Abs) has been proposed, but causality has not yet proven in an animal model. The aim of this study was to provide such evidence using pigs immunized against PEG, which displayed very high levels of anti-PEG antibodies (Abs). We also aimed to find evidence for a role of complement activation and thromboxane A2 release in blood to explore the mechanism of anaphylaxis.
METHODS
Pigs (n = 6) were immunized with 0.1 mg/kg PEGylated liposome (Doxebo) i.v., and the rise of anti-PEG IgG and IgM were measured in serial blood samples with ELISA. After ∼2-3 weeks the animals were injected i.v. with 1/3 human dose of the PEGylated mRNA vaccine, Comirnaty, and the hemodynamic (PAP, SAP) cardiopulmonary (HR, EtCO2,), hematological (WBC, granulocyte, lymphocyte and platelet counts) parameters and blood immune mediators (anti-PEG IgM and IgG antibodies, thromboxane B2, C3a) were measured as endpoints of HSRs (anaphylaxis).
RESULTS
The level of anti-PEG IgM and IgG rose 5-10-thousand-fold in all of 6 pigs immunized with Doxebo by day 6, after which time all animals developed anaphylactic shock to i.v. injection of 1/3 human dose of Comirnaty. The reaction, starting within 1 min involved maximal pulmonary hypertension and decreased systemic pulse pressure amplitude, tachycardia, granulo- and thrombocytopenia, and skin reactions (flushing or rash). These physiological changes or their absence were paralleled by C3a and TXB2 rises in blood.
CONCLUSIONS
Consistent with previous studies, these data show a causal role of anti-PEG Abs in the anaphylaxis to Comirnaty, which involves complement activation, and, hence, it represents C activation-related pseudo-anaphylaxis. The setup provides the first large-animal model for mRNA-vaccine-induced anaphylaxis in humans.
PubMed: 38933697
DOI: 10.1016/j.jvacx.2024.100497