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Trials Jul 2024Cardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation...
Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA).
BACKGROUND
Cardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication.
METHODS
The intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4-5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done.
DISCUSSION
The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment.
TRIAL REGISTRATION
The trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.
Topics: Humans; Medication Adherence; India; Community Health Workers; Cardiovascular Diseases; Randomized Controlled Trials as Topic; Cost-Benefit Analysis; Reminder Systems; Telemedicine; House Calls; Implementation Science; Treatment Outcome; Cardiovascular Agents; Multicenter Studies as Topic
PubMed: 38956612
DOI: 10.1186/s13063-024-08244-0 -
BMC Cancer Jul 2024Developing cancer in young adulthood is a non-normative life event and associated with adverse physical, social and psychological consequences. High psychological... (Randomized Controlled Trial)
Randomized Controlled Trial
Peer2Me - evaluation of a peer supported program for adolescent and young adult (AYA) cancer patients: study protocol of a randomised trial using a comprehensive cohort design.
BACKGROUND
Developing cancer in young adulthood is a non-normative life event and associated with adverse physical, social and psychological consequences. High psychological distress is common in AYA cancer patients including anxiety, depression or fear of recurrence. At the same time, it is well known that AYA often report unmet needs for support, particularly in terms of informational exchange and emotional support from peers in order to benefit from shared experiences and enhance self-efficacy. Especially in the AYA group, interactions with other same-aged cancer patients may represent an essential resource in terms of coping with the disease, as family members and friends are often overwhelmed and struggling with helplessness. Currently, there is a lack of professional support services using peer support (e.g. psycho-oncological support, aftercare consultations, social legal counselling) or evaluated peer support interventions in Germany. Our aim is to assess the effectiveness of the Peer2Me intervention for AYAs, in which acute patients (mentees) are accompanied by an AYA survivor (mentor) over a period of three months.
METHODS
A prospective Comprehensive Cohort Design with repeated measures will be used to evaluate the effectiveness of Peer2Me for AYA. A sample of 180 patients in active cancer treatment aged 18 to 39 years will be enrolled and randomized to the intervention or control condition (a single AYA-specific consultation). Following mentor training, mentees and mentors are matched by diagnosis, age, and gender. The primary outcome is self-efficacy; secondary outcomes include measures of anxiety, depression, health literacy, life satisfaction and social support life. Outcomes will be measured at baseline before the intervention (t1), immediately after completion of the three-month intervention (t2) and three months after completion the intervention (t3). For the final analyses, we will use an intention-to-treat approach (ITT) and compare patients in the assigned treatment groups.
DISCUSSION
Peer2Me might be an important addition to existing professional psychosocial support services for young cancer patients. At the end of the study, a psycho-oncological intervention for young cancer patients undergoing acute treatment should be available, from which both mentors and mentees could benefit. The long-term continuity of Peer2Me should be ensured through collaboration with different partners.
TRIAL REGISTRATION
The study was retrospectively registered on February 4, 2022 at clinicaltrials.gov (NCT05336318).
Topics: Humans; Peer Group; Adolescent; Young Adult; Neoplasms; Adult; Female; Social Support; Male; Prospective Studies; Adaptation, Psychological; Cancer Survivors; Quality of Life; Germany; Randomized Controlled Trials as Topic
PubMed: 38956510
DOI: 10.1186/s12885-024-12547-5 -
Signal Transduction and Targeted Therapy Jul 2024More than 90% of hepatocellular carcinoma (HCC) cases develop in the presence of fibrosis or cirrhosis, making the tumor microenvironment (TME) of HCC distinctive due to...
More than 90% of hepatocellular carcinoma (HCC) cases develop in the presence of fibrosis or cirrhosis, making the tumor microenvironment (TME) of HCC distinctive due to the intricate interplay between cancer-associated fibroblasts (CAFs) and cancer stem cells (CSCs), which collectively regulate HCC progression. However, the mechanisms through which CSCs orchestrate the dynamics of the tumor stroma during HCC development remain elusive. Our study unveils a significant upregulation of Sema3C in fibrotic liver, HCC tissues, peripheral blood of HCC patients, as well as sorafenib-resistant tissues and cells, with its overexpression correlating with the acquisition of stemness properties in HCC. We further identify NRP1 and ITGB1 as pivotal functional receptors of Sema3C, activating downstream AKT/Gli1/c-Myc signaling pathways to bolster HCC self-renewal and tumor initiation. Additionally, HCC cells-derived Sema3C facilitated extracellular matrix (ECM) contraction and collagen deposition in vivo, while also promoting the proliferation and activation of hepatic stellate cells (HSCs). Mechanistically, Sema3C interacted with NRP1 and ITGB1 in HSCs, activating downstream NF-kB signaling, thereby stimulating the release of IL-6 and upregulating HMGCR expression, consequently enhancing cholesterol synthesis in HSCs. Furthermore, CAF-secreted TGF-β1 activates AP1 signaling to augment Sema3C expression in HCC cells, establishing a positive feedback loop that accelerates HCC progression. Notably, blockade of Sema3C effectively inhibits tumor growth and sensitizes HCC cells to sorafenib in vivo. In sum, our findings spotlight Sema3C as a novel biomarker facilitating the crosstalk between CSCs and stroma during hepatocarcinogenesis, thereby offering a promising avenue for enhancing treatment efficacy and overcoming drug resistance in HCC.
Topics: Liver Neoplasms; Humans; Carcinoma, Hepatocellular; Tumor Microenvironment; Semaphorins; Integrin beta1; Mice; Signal Transduction; Hepatic Stellate Cells; Neuropilin-1; Cell Line, Tumor; Neoplastic Stem Cells; Animals; Gene Expression Regulation, Neoplastic; Sorafenib; Cancer-Associated Fibroblasts; Disease Progression
PubMed: 38956074
DOI: 10.1038/s41392-024-01887-0 -
The AAPS Journal Jul 2024The paper highlights the necessity for a robust regulatory framework for assessing nanomedicines and their off-patent counterparts, termed as nanosimilar, which could be... (Review)
Review
The paper highlights the necessity for a robust regulatory framework for assessing nanomedicines and their off-patent counterparts, termed as nanosimilar, which could be considered as 'similar' to the prototype nanomedicine,based on essential criteria describing the 'similarity'. The term 'similarity' should be focused on criteria that describe nanocarriers, encompassing their physicochemical, thermodynamic, morphological, and biological properties, including surface interactions and pharmacokinetics. Nanocarriers can be regarded as advanced self-assembled excipients (ASAEs) due to their complexity and chaotic behavior and should be evaluated by using essential criteria in order for off-patent nanomedicines be termed as nanosimilars, from a regulatory perspective. Collaboration between the pharmaceutical industry, regulatory bodies, and artificial intelligence (AI) startups is pivotal for the precise characterization and approval processes for nanomedicines and nanosimilars and embracing innovative tools and terminology facilitates the development of a sustainable regulatory framework, ensuring safety and efficacy. This crucial shift toward precision R&D practices addresses the complexity inherent in nanocarriers, paving the way for therapeutic advancements with economic benefits.
Topics: Nanomedicine; Humans; Biosimilar Pharmaceuticals; Artificial Intelligence; Nanoparticles; Drug Industry; Drug Approval; Drug Carriers
PubMed: 38955936
DOI: 10.1208/s12248-024-00942-6 -
Journal of the American Chemical Society Jul 2024The messenger RNA (mRNA) vaccines hold great significance in contagion prevention and cancer immunotherapy. However, safely and effectively harnessing innate immunity to...
The messenger RNA (mRNA) vaccines hold great significance in contagion prevention and cancer immunotherapy. However, safely and effectively harnessing innate immunity to stimulate robust and durable adaptive immune protection is crucial, yet challenging. In this study, we synthesized a library of stimuli-responsive bivalent ionizable lipids (srBiv iLPs) with smart molecular blocks responsive to esterase, HO, cytochrome P450, alkaline phosphatase, nitroreductase, or glutathione (GSH), aiming to leverage physiological cues to trigger fast lipid degradation, promote mRNA translation, and induce robust antitumor immunity via reactive oxygen species (ROS)-mediated boosting. After subcutaneous immunization, esterase-responsive vaccine (eBiv-mVac) was rapidly internalized and transported into the draining lymph nodes. It then underwent fast decaging and self-immolative degradation in esterase-rich antigen-presenting cells, releasing sufficient mRNA for antigen translation and massive reactive quinone methides to elevate ROS levels. This resulted in broad activation of innate immunity to boost T cell response, prompting a large number of primed antigen-specific CD8 T cells to circulate and infiltrate into tumors (>1000-fold versus unvaccinated control), thereby orchestrating innate and adaptive immunity to control tumor growth. Moreover, by further combining our vaccination strategy with immune checkpoint blockade, we demonstrated a synergism that significantly amplified the magnitude and function of antigen-specific CD8 T cells. This, in turn, caused potent systemic antitumor efficacy and prolonged survival with high complete response rate in xenograft and metastasis models. Overall, our generalized stimuli-responsive mRNA delivery platform promises a paradigm shift in the design of potent vaccines for cancer immunotherapy, as well as effective and precise carriers for gene editing, protein replacement, and cell engineering.
PubMed: 38955767
DOI: 10.1021/jacs.4c04331 -
Australasian Emergency Care Jul 2024The nursing field is the fourth most stressful occupation in the health sector. Emergency department nurses often face crises and unpredictable situations that can...
BACKGROUND
The nursing field is the fourth most stressful occupation in the health sector. Emergency department nurses often face crises and unpredictable situations that can negatively affect their quality of life and the quality of care. This study aimed to investigate the determinants of work stress among ED nurses in Sleman, Yogyakarta, Indonesia.
METHODS
A descriptive cross-sectional study was conducted. Participants (n = 122) were emergency nurses recruited through convenience sampling from four EDs in Sleman District, Yogyakarta, Indonesia. Data were gathered using an online self-administered survey consisting of the workload, self-efficacy, and work stress questionnaires. Hierarchical linear regression analysis with the entry method was used to examine the main determinants of work stress.
RESULTS
The average work stress (38.29 ± 8), workload (30.83 ± 9.21), and self-efficacy (32.47 ± 3.61) scores were at a moderate level. Hierarchical linear regression showed that workplace, being a head nurse, and workload were the main determinants that contributed to 25.4 % of work stress among ED nurses.
CONCLUSIONS
The study results confirm that having a high workload, working in a private hospital, and being a head nurse are the main determinants of work stress among ED nurses in Sleman, Indonesia.
PubMed: 38955609
DOI: 10.1016/j.auec.2024.06.002 -
Virology Jun 2024There is an urgent need for influenza vaccines that offer broad cross-protection. The highly conserved ectodomain of the influenza matrix protein 2 (M2e) is a promising...
There is an urgent need for influenza vaccines that offer broad cross-protection. The highly conserved ectodomain of the influenza matrix protein 2 (M2e) is a promising candidate; however, its low immunogenicity can be addressed. In this study, we developed influenza vaccines using the Lumazine synthase (LS) platform. The primary objective of this study was to determine the protective potential of M2e proteins expressed on Lumazine synthase (LS) nanoparticles. M2e-LS proteins, produced through the E. coli system, spontaneously assemble into nanoparticles. The study investigated the efficacy of the M2e-LS nanoparticle vaccine in mice. Mice immunized with M2e-LS nanoparticles exhibited significantly higher levels of intracellular cytokines than those receiving soluble M2e proteins. The M2e-LS protein exhibited robust immunogenicity and provided 100% protection against cross-clade influenza.
PubMed: 38955082
DOI: 10.1016/j.virol.2024.110162 -
Geriatric Nursing (New York, N.Y.) Jul 2024This study aimed to investigate factors affecting physical activity (PA) among elderly stroke survivors living in the community and assess the mediating role of exercise...
AIM
This study aimed to investigate factors affecting physical activity (PA) among elderly stroke survivors living in the community and assess the mediating role of exercise planning in the relationship between exercise self-efficacy and PA.
METHODS
300 participants were surveyed using questionnaires and scales, with data analyzed using SPSS 26.0.
RESULTS
Univariate analysis identified sociological, disease-related factors, exercise self-efficacy, and exercise planning as influencing PA. Ordered logistic regression showed significant associations between PA, exercise self-efficacy (OR 1.093, 95 % CI 1.055-1.133, P < 0.001), and exercise planning (OR 1.296, 95 % CI 1.202-1.398, P < 0.001). Exercise planning partially mediated the relationship between exercise self-efficacy and PA, accounting for 64.86 % of the total effect.
CONCLUSIONS
Multiple factors, including sociological and disease-related ones, as well as exercise self-efficacy and planning, influence PA in elderly stroke survivors. Exercise planning partially mediates the relationship between exercise self-efficacy and PA.
PubMed: 38955038
DOI: 10.1016/j.gerinurse.2024.06.017 -
European Journal of Oncology Nursing :... Jun 2024Physical activity (PA) is beneficial but difficult to maintain during chemotherapy. This pilot RCT explored the feasibility of the MI-Walk intervention-an 8-week...
PURPOSE
Physical activity (PA) is beneficial but difficult to maintain during chemotherapy. This pilot RCT explored the feasibility of the MI-Walk intervention-an 8-week motivational enhancement therapy- and home-based brisk walking intervention-among gastrointestinal (GI) cancer survivors receiving chemotherapy.
METHODS
Sixty stage II-IV GI cancer survivors were recruited from 5 sites at their second infusion visit. Participants were randomized to receive PA education alone or the MI-Walk intervention: motivational enhancement therapy consisting of 3 motivational interviewing and self-efficacy-enhancing counseling sessions, a Fitbit Charge 2, exercise diaries, telephone follow-up, scripted motivational email messages, and optional weekly walking groups.
RESULTS
The enrollment and completion rates were 62% and 90%, respectively. The MI-Walk participants (n = 29; mean age = 56.79, SD = 11.72; 97% white; 79% male) reported a baseline moderate-vigorous PA duration of 250.93 (SD = 636.52) min/wk. The mean MI-Walk Intervention acceptability score was 50.32 (SD = 12.02) on a scale of 14-70. Mean Fitbit and counseling helpfulness scores on a 5-point scale were 3.67 (SD = 1.43) and 3.44 (SD = 1.36), respectively. Participants' Fitbit moderate-vigorous PA 8-week averages ranged from 0 to 716.88 min/wk; 64% of participants adhered to ≥127 min/wk. Several characteristics (e.g., age, comorbidity, PA level, employment status, BMI, education level, gender, symptoms) were associated with enrollment, attrition, and intervention acceptability and adherence (p < 0.05).
CONCLUSION
Enrollment and retention were adequate. The Fitbit and counseling were the most helpful. Acceptability and adherence varied based on participant characteristics; therefore, intervention tailoring and further research among cancer survivors less physically active at baseline and most in need of complex exercise intervention are needed.
CLINICALTRIALS
gov NCT03515356.
PubMed: 38954929
DOI: 10.1016/j.ejon.2024.102649 -
ACS Applied Bio Materials Jul 2024In the realm of clinical applications, the concern surrounding biomedical device-related infections (BDI) is paramount. To mitigate the risk associated with BDI,...
In the realm of clinical applications, the concern surrounding biomedical device-related infections (BDI) is paramount. To mitigate the risk associated with BDI, enhancing surface characteristics such as lubrication and antibacterial efficacy is considered as a strategic approach. This study delineated the synthesis of a multifunctional copolymer, embodying self-adhesive, lubricating, and antibacterial properties, achieved through free radical polymerization and a carbodiimide coupling reaction. The copolymer was adeptly modified on the surface of stainless steel 316L (SS316L) substrates by employing a facile dip-coating technique. Comprehensive characterizations were performed by using an array of analytical techniques including Fourier transform infrared spectroscopy, X-ray photoelectron spectroscopy, optical interferometry, scanning electron microscopy, and atomic force microscopy. Nanoscale tribological assessments revealed a notable reduction in the value of the friction coefficient of the copolymer-coated SS316L substrates compared to bare SS316L samples. The coating demonstrated exceptional resistance to protein adsorption, as evidenced in protein contamination models employing bovine serum albumin and fibrinogen. The bactericidal efficacy of the copolymer-modified surfaces was significantly improved against pathogenic strains such as and . Additionally, evaluations of blood compatibility and cellular compatibility underscored the remarkable anticoagulant performance and biocompatibility. Collectively, these findings indicated that the developed copolymer coating represented a promising candidate, with its facile modification approach, for augmenting lubrication and antifouling properties in the field of biomedical implant applications.
PubMed: 38954747
DOI: 10.1021/acsabm.4c00144