Tag: pubmed

J Glaucoma. 2024 Jul 17. doi: 10.1097/IJG.0000000000002466. Online ahead of print.

ABSTRACT

PRCIS: Selective laser trabeculoplasty (SLT) and medical therapy groups displayed comparable intraocular pressure (IOP) at most follow-ups. SLT was associated with significantly decreased rates of glaucoma surgeries, antiglaucomatous medications, and ocular adverse effects.

PURPOSE: To evaluate the efficacy and safety of selective laser trabeculoplasty (SLT) compared to medical therapy in the treatment of open-angle glaucoma (OAG) or ocular hypertension (OHT).

METHODS: A systematic search was performed in PubMed, Embase, Cochrane Library and Web of Science databases. Randomized controlled trials (RCTs) comparing SLT with medical therapy were included. We computed mean differences (MDs) or standardized mean differences (STDs) for continuous endpoints and risk ratios (RRs) for binary endpoints, with 95% confidence intervals (CIs). Heterogeneity was assessed with I2 statistics. Software R, version 4.2.1, was used for statistical analyses. Subgroup analyses were performed on treatment-naive patients and on the class of drugs in the medical therapy group.

RESULTS: Fourteen RCTs comprising 1,706 patients were included, of whom 936 were submitted to SLT. Medical therapy was associated with a significantly improved IOP at 1 month and a higher proportion of patients achieving ≥20% IOP reduction. There were no significant differences between groups in IOP at 2, 3, 6, and 12 months, IOP fluctuation, rate of eyes at target IOP, visual field, and quality of life. The SLT group exhibited significantly decreased rates of glaucoma surgeries, antiglaucoma medications, and ocular adverse effects.

CONCLUSION: SLT demonstrated comparable efficacy to medical therapy in IOP control at most follow-ups, along with favorable impacts on critical treatment-related factors. Our findings support SLT as a safe and effective treatment for OAG or OHT.

PMID:39018052 | DOI:10.1097/IJG.0000000000002466

JAMA Dermatol. 2024 Jul 17. doi: 10.1001/jamadermatol.2024.2131. Online ahead of print.

ABSTRACT

IMPORTANCE: Cendakimab selectively targets interleukin (IL)-13, a type 2 cytokine implicated in atopic dermatitis (AD) pathogenesis, by inhibiting binding to its receptors (IL13R-α1 and IL13R-α2). Proof-of-concept work in AD supports using cendakimab for type 2 inflammatory diseases.

OBJECTIVE: To evaluate the efficacy and safety of cendakimab compared with placebo in patients with moderate to severe AD.

DESIGN, SETTING, AND PARTICIPANTS: This phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging clinical trial was conducted from May 2021 to November 2022. Adult patients with moderate to severe AD and inadequate response to topical medications were enrolled at 69 sites in 5 countries (US [n = 26], Japan [n = 17], Canada [n = 9], Poland [n = 9], and Czech Republic [n = 8]). Data were analyzed between April 25, 2023, and October 16, 2023.

INTERVENTIONS: Patients were randomized (1:1:1:1) to receive subcutaneous cendakimab, 360 mg, every 2 weeks; 720 mg, every 2 weeks; 720 mg, once weekly; or placebo.

MAIN OUTCOME AND MEASURE: Mean percentage change in Eczema Area and Severity Index scores from baseline to week 16. Hierarchical testing with multiplicity adjustment was performed for 720 mg, once weekly vs placebo, then 720 mg, every 2 weeks vs placebo, and then 360 mg, every 2 weeks vs placebo.

RESULTS: Overall, 221 patients were randomized, and 220 received study drug (95 women [43%]; mean [SD] age, 37.7 [13.9] years; 720 mg, once weekly [54 (24%)]; 720 mg, every 2 weeks [55 (25%)]; 360 mg, every 2 weeks [55 (25%)]; placebo [56 (26%)]). The primary efficacy end point was met for cendakimab, 720 mg, once weekly vs placebo (-84.4 vs -62.7; P = .003) but missed statistical significance for 720 mg, every 2 weeks (-76.0 vs -62.7; P = .06). The treatment effect for 360 mg, every 2 weeks (-16.3; nominal P = .03 vs placebo) was comparable with 720 mg, once weekly (-21.8); however, significance was not claimed because the hierarchical testing sequence was interrupted. Of patients with treatment-emergent adverse events leading to discontinuation, 4 (7.4%) received 720 mg, once weekly; 2 (3.6%) 720 mg, every 2 weeks; 1 (1.8%) 360 mg, every 2 weeks; and 2 (3.6%) placebo.

CONCLUSIONS AND RELEVANCE: The results of this randomized clinical trial indicated that cendakimab was effective, generally safe, and well-tolerated in patients with moderate to severe AD. The primary end point was met with a significant reduction in Eczema Area and Severity Index scores with 720 mg, once weekly at week 16. Cendakimab demonstrated progressive AD improvement at all doses during 16 weeks of treatment.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04800315.

PMID:39018038 | DOI:10.1001/jamadermatol.2024.2131

J Glaucoma. 2024 Jul 17. doi: 10.1097/IJG.0000000000002459. Online ahead of print.

ABSTRACT

PRCIS: Preserflo® surgery is a safe procedure, effective in reducing intraocular pressure into the “low teens”, surgical survival is greatest in cases of high baseline intraocular pressure (above 21 mmHg) and when performed as a standalone procedure.

PURPOSE: To evaluate midterm surgical survival and safety profile of Preserflo® filtering surgery.

METHODS: Retrospective, cohort study. Consecutive patients who underwent standardized Preserflo® implantation with mitomycin C from December 2019 to April 2021 were included. Clinical data was retrieved from patient charts. Primary outcome was surgical survival at twenty-four months in accordance with World Glaucoma Association guidelines. Survival was evaluated using Kaplan-Meier statistics. Analysis was performed at eye-level and as intention-to-treat.

RESULTS: Ninety-five eyes were included in this study (18 cases combined with cataract surgery). Over half of cases (n=51) were primary open angle glaucoma, with over a fifth having a prior filtering glaucoma procedure. Intraocular pressure at twenty-four months was significantly decreased from baseline (22.4±6.28 mmHg vs 12.0±3.43 mmHg), as well as the need for IOP-lowering medication (2.88 (±0.92) vs 0.79 (±1.3), P<0.001 all comparisons. Standalone Preserflo® achieved a qualified survival (irrespective of medication) of 71% (CI 95% 62%-83%) and 44% (CI 95% 27%-75%) in the combined procedure subgroup (P<0.05 when considering absolute survival). Eyes with baseline intraocular pressure ≥21 mmHg showed a greater qualified survival when compared to eyes with baseline ≤18 mmHg (80% (CI 95% 65%-100%) vs (50% (CI 95% 32%-76%; P<0.05). Intra and early operative complications were few, self-limited, and did not require surgical management. The reoperation rate was low (18%).

CONCLUSION: Preserflo ® filtering surgery is effective in reducing intraocular pressure into the “low teens” and presents an adequate surgical survival and safety profile. Surgical survival appears greatest when performed as standalone and when pre-operative intraocular pressure is high (≥21 mmHg).

PMID:39018034 | DOI:10.1097/IJG.0000000000002459

Int J Qual Health Care. 2024 Jul 17:mzae060. doi: 10.1093/intqhc/mzae060. Online ahead of print.

ABSTRACT

Background Control charts, used in healthcare operations to monitor process stability and quality, are essential for ensuring patient safety and improving clinical outcomes. This comprehensive research study aims to provide a thorough understanding of the role of control charts in healthcare quality monitoring and future perspectives by utilizing a dual methodology approach involving a systematic review and a pioneering bibliometric analysis. Materials and Methods A systematic review of 73 out of 223 articles was conducted, synthesizing existing literature (1995-2023) and revealing insights into key trends, methodological approaches, and emerging themes of control charts in healthcare. In parallel, a bibliometric analysis (1990-2023) on 184 articles gathered from Web of Science and Scopus was performed, quantitatively assessing the scholarly landscape encompassing control charts in healthcare. Results Among 25 countries the United States is the foremost user of control charts, accounting for 33% of all applications, whereas among 14 health departments, epidemiology leads with 28% of applications. The practice of control charts in health monitoring increased by more than one-third during the last three years. Globally, Exponentially Weighted Moving Average (EWMA) charts are the most popular, but interestingly the USA remained the top user of Shewhart charts. The study also uncovers a dynamic landscape in healthcare quality monitoring, with key contributors, research networks, research hotspot tendencies, and leading countries. Influential authors, such as J.C. Benneyan, W.H. Woodall, and M.A. Mohammed played a leading role in this field. In-countries networking, USA-UK leads the largest cluster, while other clusters include Denmark-Norway-Sweden, China-Singapore, and Canada-South Africa. From 1990 to 2023, healthcare monitoring evolved from studying efficiency to focusing on conditional monitoring and flowcharting, with human health, patient safety, and health surveys dominating 2011-2020, and recent years emphasizing epidemic control, COVID-19 SPC, hospitals, and human health monitoring using control charts. It identifies a transition from conventional to artificial intelligence (AI) approaches, with increasing contributions from machine learning (ML) and deep learning (DL) in the context of Industry 4.0. New researchers and journals are emerging, reshaping the academic context of control charts in healthcare. Discussion and Conclusion Our research reveals the evolving landscape of healthcare quality monitoring, surpassing traditional reviews. We uncover emerging trends, research gaps, and a transition in leadership from established contributors to newcomers amidst technological advancements. This study deepens the importance of control charts, offering insights for healthcare professionals, researchers, and policymakers to enhance healthcare quality. Future challenges and research directions are also provided.

PMID:39018022 | DOI:10.1093/intqhc/mzae060

Infection. 2024 Jul 17. doi: 10.1007/s15010-024-02347-1. Online ahead of print.

ABSTRACT

BACKGROUND: WHO postulates the application of adaptive design features in the global clinical trial ecosystem. However, the adaptive platform trial (APT) methodology has not been widely adopted in clinical research on vaccines.

METHODS: The VACCELERATE Consortium organized a two-day workshop to discuss the applicability of APT methodology in vaccine trials under non-pandemic as well as pandemic conditions. Core aspects of the discussions are summarized in this article.

RESULTS: An “ever-warm” APT appears ideally suited to improve efficiency and speed of vaccine research. Continuous learning based on accumulating APT trial data allows for pre-planned adaptations during its course. Given the relative design complexity, alignment of all stakeholders at all stages of an APT is central. Vaccine trial modelling is crucial, both before and in a pandemic emergency. Various inferential paradigms are possible (frequentist, likelihood, or Bayesian). The focus in the interpandemic interval may be on research gaps left by industry trials. For activation in emergency, template Disease X protocols of syndromal design for pathogens yet unknown need to be stockpiled and updated regularly. Governance of a vaccine APT should be fully integrated into supranational pandemic response mechanisms.

DISCUSSION: A broad range of adaptive features can be applied in platform trials on vaccines. Faster knowledge generation comes with increased complexity of trial design. Design complexity should not preclude simple execution at trial sites. Continuously generated evidence represents a return on investment that will garner societal support for sustainable funding. Adaptive design features will naturally find their way into platform trials on vaccines.

PMID:39017997 | DOI:10.1007/s15010-024-02347-1

Appl Health Econ Health Policy. 2024 Jul 17. doi: 10.1007/s40258-024-00902-3. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Globally, emergency medical services (EMSs) report that their demand is dominated by non-emergency (such as urgent and primary care) requests. Appropriately managing these is a major challenge for EMSs, with one mechanism employed being specialist community paramedics. This review guides policy by evaluating the economic impact of specialist community paramedic models from a healthcare system perspective.

METHODS: A multidisciplinary team (health economics, emergency care, paramedicine, nursing) was formed, and a protocol registered on PROSPERO (CRD42023397840) and published open access. Eligible studies included experimental and analytical observational study designs of economic evaluation outcomes of patients requesting EMSs via an emergency telephone line (‘000’, ‘111’, ‘999’, ‘911’ or equivalent) responded to by specialist community paramedics, compared to patients attended by usual care (i.e. standard paramedics). A three-stage systematic search was performed, including Peer Review of Electronic Search Strategies (PRESS) and Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). Two independent reviewers extracted and verified 51 unique characteristics from 11 studies, costs were inflated and converted, and outcomes were synthesised with comparisons by model, population, education and reliability of findings.

RESULTS: Eleven studies (n = 7136 intervention group) met the criteria. These included one cost-utility analysis (measuring both costs and consequences), four costing studies (measuring cost only) and six cohort studies (measuring consequences only). Quality was measured using Joanna Briggs Institute tools, and was moderate for ten studies, and low for one. Models included autonomous paramedics (six studies, n = 4132 intervention), physician oversight (three studies, n = 932 intervention) and/or special populations (five studies, n = 3004 intervention). Twenty-one outcomes were reported. Models unanimously reduced emergency department (ED) transportation by 14-78% (higher quality studies reduced emergency department transportation by 50-54%, n = 2639 intervention, p < 0.001), and costs were reduced by AU$338-1227 per attendance in four studies (n = 2962). One study performed an economic evaluation (n = 1549), finding both that the costs were reduced by AU$454 per attendance (although not statistically significant), and consequently that the intervention dominated with a > 95% chance of the model being cost effective at the UK incremental cost-effectiveness ratio threshold.

CONCLUSIONS: Community paramedic roles within EMSs reduced ED transportation by approximately half. However, the rate was highly variable owing to structural (such as local policies) and stochastic (such as the patient’s medical condition) factors. As models unanimously reduced ED transportation-a major contributor to costs-they in turn lead to net healthcare system savings, provided there is sufficient demand to outweigh model costs and generate net savings. However, all models shift costs from EDs to EMSs, and therefore appropriate redistribution of benefits may be necessary to incentivise EMS investment. Policymakers for EMSs could consider negotiating with their health department, local ED or insurers to introduce a rebate for successful community paramedic non-ED-transportations. Following this, geographical areas with suitable non-emergency demand could be identified, and community paramedic models introduced and tested with a prospective economic evaluation or, where this is not feasible, with sufficient data collection to enable a post hoc analysis.

PMID:39017994 | DOI:10.1007/s40258-024-00902-3

Inflammopharmacology. 2024 Jul 17. doi: 10.1007/s10787-024-01522-y. Online ahead of print.

ABSTRACT

The aim of this study was to develop and evaluate bilosomes loaded with Celecoxib (CXB) for the efficient treatment of Alzheimer. The thin-film hydration approach was utilized in the formulation of CXB bilosomes (CXB-BLs). The study used a 2³-factorial design to investigate the impact of several formulation variables. Three separate parameters were investigated: bile salt type (X₁), medication amount (X₂), and lipid-bile salt ratio (X₃). The dependent responses included entrapment efficiency (Y₁: EE %), particle size (Y₂: PS), and zeta potential (_Y3: ZP). The formulation factors were statistically optimized using the Design-Expert^® program. The vesicles demonstrated remarkable CXB encapsulation efficiency, ranging from 94.16 ± 1.91 to 98.38 ± 0.85%. The vesicle sizes ranged from 241.8 ± 6.74 to 352 ± 2.34 nm. The produced formulations have high negative zeta potential values, indicating strong stability. Transmission electron microscopy (TEM) revealed that the optimized vesicles had a spherical form. CXB release from BLs was biphasic, with the release pattern following Higuchi’s model. In vivo studies confirmed the efficiency of CXB-BLs in management of lipopolysaccharide-induced Alzheimer as CXB-BLs ameliorated cognitive dysfunction, decreased acetylcholinesterase (AChE), and inhibited neuro-inflammation and neuro-degeneration through reducing Toll-like receptor (TLR4), and Interleukin-1β (IL-1β) levels. The findings suggested that the created CXB-BLs could be a potential drug delivery strategy for Alzheimer’s treatment.

PMID:39017993 | DOI:10.1007/s10787-024-01522-y

Parasitol Res. 2024 Jul 17;123(7):273. doi: 10.1007/s00436-024-08288-w.

ABSTRACT

Blastocystis is an intestinal protist frequently identified in humans and other animals, though its clinical significance remains controversial. This study aimed to determine the prevalence and genetic diversity of Blastocystis in faecal samples from symptomatic (n = 55) and asymptomatic (n = 50) individuals seeking medical care in Meknes, Morocco. Detection of the protist was accomplished through coproparasitological examination and culture in Jones medium. Culture-positive samples were subjected to molecular analyses (PCR and Sanger sequencing) based on sequences of the small subunit ribosomal RNA gene. Epidemiological questionnaires on demographics and potential risk factors were collected from participating patients. The overall Blastocystis infection rate was 51.4% (54/105), with no differences between symptomatic (52.7%, 29/55) and asymptomatic (50.0%, 25/50) individuals. Sequence analyses identified three Blastocystis subtypes, with ST3 being the most prevalent (42.0%), followed by ST1 (34.0%), and ST2 (12.0%). Regarding intra-subtype diversity, allele 4 was found within ST1; alleles 11/12 and alleles 34/36 (alone or in combination) were identified within ST2 and ST3 respectively. Allele 34 in ST3 (40.8%) and allele 4 in ST1 (34.7%) were the most common genetic variants circulating in the surveyed clinical population. A statistically significant association between ST2 and the presence of flatulence was observed. This is the first study assessing the epidemiology and genetic diversity of Blastocystis sp. in the Meknes region, Morocco.

PMID:39017986 | DOI:10.1007/s00436-024-08288-w

Environ Geochem Health. 2024 Jul 17;46(9):330. doi: 10.1007/s10653-024-02036-w.

ABSTRACT

This study aims to assess the amount of organic carbon stored in soils, as it is an intention of knowing the sustainable soil management, by using two common methods for determining soil organic matter (SOM), namely oxidation with acidified wet dichromate (Walkley-Black method-WB) and loss on ignition (LOI). The study was carried with soil samples collected from a depth of 0 to 30 cm in the Saharan arid region of Ghardaïa (Algeria), with different land uses: agricultural, forest and pastoral. The results obtained from the LOI and WB methods were subjected to statistical analysis, and the relations between both methods were tested to investigate their relationship. The mean percentage of SOM values were 1.86, 2.42, 1.54 by using LOI, but, lower values of 0.34, 0.33, 0.36 were determined by using WB method, for agricultural, forest and pastoral soils respectively. A weak linear relationship between the two analytical procedures was obtained (R² of 0.19 and 0.13 for agricultural and forest soils), while a medium relationship (R² = 0.65) was found for pastoral soils when using linear adjustment. However, the opposite behaviour was found when we use the logarithmic adjustment. The study outcomes indicated discrepancies in the measurements of SOM values between the two methods, been higher those estimated with LOI. Finally, in order to identify the best methodology to measure soil organic matter in arid soils, more research is required in these extreme arid regions as they are a gap in world soil organic matter maps.

PMID:39017950 | DOI:10.1007/s10653-024-02036-w

Environ Geochem Health. 2024 Jul 17;46(9):331. doi: 10.1007/s10653-024-02112-1.

ABSTRACT

The research aims to evaluate the source, dispersion, and human health risk assessment of PAH-contaminated Talinum Triangulare grown along the polluted Ikpoba River. The freeze-dried vegetables were sonicated with dichloromethane for an hour and then concentrated using a rotary evaporator. The extract was purified using a glass column with anhydrous Na₂SO₄ and silica gel and analyzed using gas chromatography-mass spectrometry (GC-MS). The distribution of the contaminants showed that Pyrene < Benzo(a)anthracene ≤ Fluorene < Phenathrene ≤ Naphthalene ≤ Acenaphthene < Anthracene ≤ Acenaphthylene, while Pyrene < Benzo(a)anthracene < Fluorene < Phenathrene < Acenaphthalene ≤ Naphthalene < Anthracene < Acenaphthylene in wet and dry periods, respectively. The average ∑₈ PAHs was 0.85 mg/kg and 0.75 mg/kg in wet and dry periods, respectively, and showed a decrease of 17.64% from wet to dry periods. The daily average dose revealed that the infant male and the adult female consumed the least and highest doses of T. Triangulare (TT), respectively. Furthermore, the hazard quotient and hazard index were < 1 for all the target groups, with adult females having higher values in both seasons. However, the incremental life cancer risk of the target group was between potential and high-potential cancer risk, with adolescent males and adult females more prone to low and high cancer risk, respectively. The isomer ratio and multivariate statistics revealed the sources of the PAH-contaminated TT to be more from pyrolysis.

PMID:39017947 | DOI:10.1007/s10653-024-02112-1