Novel imaging techniques for tumor margin detection in basal cell carcinoma: a systematic scoping review of FDA and EMA-approved imaging modalities.

Mohs micrographic surgery (MMS) is the gold standard for removing basal cell carcinomas (BCCs) due to its ability to guarantee 100% margin evaluation through frozen section histopathology, offering the highest cure rate among current treatments. However, noninvasive imaging technologies have emerged as promising alternatives to clinical assessment for defining presurgical margins. This systematic scoping review examines the efficacy of these imaging modalities, focusing on those approved for clinical use by the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). A systematic search of EMBASE, Scopus, PubMed, and the Cochrane Public Library databases identified 11 relevant studies out of 2123 records, encompassing 644 lesions across five imaging techniques. The findings suggest that dermoscopy, high-frequency ultrasound (HFUS), optical coherence tomography (OCT), line-field optical coherence tomography (LC-OCT), and reflectance confocal microscopy (RCM) show potential in detecting BCC margins, which could enhance MMS by providing better preoperative planning, informing patients of expected defect size, aiding in reconstruction decisions, and reducing overall procedure costs. This review discusses the benefits and limitations of each technique, offering insights into how these innovations could influence the future of BCC management. Emerging imaging techniques could enhance MMS by improving BCC margin assessment and reducing costs. Their adoption will depend on price and ease of use.

Pancreatitis Associated With Teduglutide: A Disproportionality Analysis via the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.

Introduction Teduglutide is a glucagon-like peptide-2 analog that is indicated for the treatment of short bowel syndrome (SBS) by reducing patient dependence on parenteral support. Due to the rarity of SBS as well as the recent timeline of the adoption of teduglutide, the safety of teduglutide is relatively poorly understood. Several recent clinical case reports have highlighted elevated pancreatic enzymes and pancreatitis as a concerning complication of teduglutide. This prompts a systematic study of the association between pancreatitis and teduglutide. Methods This study conducts a case-control design disproportionality analysis by using data from the US Food and Drug Administration Adverse Event Reporting System (FAERS). Reports from the first quarter of 2020 through the first quarter of 2024 were retrieved from this database, and a disproportionality analysis was conducted. The analysis consisted of traditional methods of analyzing adverse drug events such as the reporting odds ratio (ROR) and proportional reporting ratio (PRR), as well as Bayesian methods such as the empirical Bayes geometric mean (EBGM) and information component (IC). A confidence interval for ROR and PRR that excludes a ratio of 1 or a confidence interval for IC that excludes a score of 0 was used as the criterion for a statistically significant association between pancreatitis risk and teduglutide use. Results Out of 11,696 reports of teduglutide adverse effects in over four years of adverse effects data drawn from the FAERS database, 79 cases of pancreatitis were identified. The disproportionality analysis revealed an ROR of 3.73 (95% CI (2.99, 4.66)), a PRR of 3.71 (95% CI (2.97, 4.63)), an EBGM of 3.70, and an IC of 1.84 (95% CI (1.51, 2.16)). All of these statistics indicate a statistically significant association between pancreatitis risk and teduglutide use. Conclusion The results reveal a statistically significant association between pancreatitis risk and teduglutide use. Our findings highlight the necessity for the careful monitoring of pancreatitis in patients undergoing teduglutide therapy going forward.

Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act.

INTRODUCTION: Recent research has raised questions about potential unintended consequences of the Inflation Reduction Act's Drug Price Negotiation Program (DPNP), suggesting that the timelines introduced by the law may reduce manufacturer incentives to invest in post-approval research towards additional indications. Given the role of multiple indications in expanding treatment options in patients with cancer, IRA-related changes to development incentives are especially relevant in oncology. This study aimed to describe heterogeneous drug-level trajectories and timelines of subsequent indications in a cohort of recently approved, multi-indication oncology drugs, including overall, across subgroups of drugs characterized by the timing and pace of additional indications, and by drug type (i.e., small molecule vs. biologic). METHODS: This cross-sectional study evaluated oncology drugs first approved by the FDA from 2008 to 2018 and later approved for one or more additional indications. Numbers, types, and approval timelines of subsequent indications were recorded at the drug level, with drugs grouped by quartile based on the pacing of post-approval development (i.e., "rapid pace" to "measured pace"). RESULTS: Multi-indication oncology drugs (N = 56/86, 65.1%) had one or more subsequent indication approved in a new: cancer type (60.7%), line of treatment (50.0%), combination (41.1%), mutation (32.1%), or stage (28.6%). The median time between FDA approvals for indications increased from 0.6 years (IQR: 0.48, 0.74) in the "rapid pace" group to 1.6 years (IQR: 1.32, 1.66), 2.4 years (IQR: 2.29, 2.61), and 4.9 years (IQR: 3.43, 6.23) in the "moderate," "measured-moderate," and "measured" pace groups, respectively. Drugs in the "rapid pace" group often received their first subsequent indication approval within 9 months of initial approval (median: 0.7 years; IQR: 0.54, 1.59), whereas the "measured pace" group took a median of 5.7 years (IQR: 3.43, 6.98). Across all multi-indication drugs, the median time to the most recent approval for a subsequent indication was 5.5 years (IQR: 3.18, 7.95). One quarter (25%) of drugs were approved for their most recent subsequent indication after the time at which they would be DPNP-eligible. CONCLUSION: Approval histories of new oncology drugs demonstrate the role of post-approval indications in expanding treatment options towards new cancer types, stages, lines, combinations, and mutations. Heterogeneous clinical development pathways provide insights into potential unintended consequences of IRA-related changes surrounding post-approval research and development.

Cost-effectiveness of mass drug administration for control of scabies in Ethiopia: a decision-analytic model.

Background: The strategies to control scabies in highly endemic populations include individual case/household management and mass drug administration (MDA). We used a decision-analytic model to compare ivermectin-based MDA and individual case/household management (referred to as "usual care") for control of scabies in Ethiopia at different prevalence thresholds for commencing MDA. Methods: A decision-analytic model was based on a repeated population survey conducted in Northern Ethiopia in 2018-2020, which aimed to evaluate the secondary impact of single-dose ivermectin MDA for the control of onchocerciasis on scabies prevalence. The model estimates the number of scabies cases and costs of two treatment strategies (MDA and usual care) based on their effectiveness, population size, scabies prevalence, compliance with MDA, medication cost, and other parameters. Results: In the base-case analysis with a population of 100,000 and scabies prevalence of 15%, the MDA strategy was both more effective and less costly than usual care. The probability of MDA being cost-effective at the current cost-effectiveness threshold (equivalent to the cost of usual care) was 85%. One-way sensitivity analyses showed that the MDA strategy remained dominant (less costly and more effective) in 22 out of 26 scenarios. MDA was not cost-effective at scabies prevalence <10%, MDA effectiveness <85% and population size <5,000. An increase in the cost of ivermectin from 0 (donated) to 0.54 US$/dose resulted in a decrease in the probability of MDA being cost-effective from 85% to 17%. At 0.25 US$/dose, the MDA strategy was no longer cost-effective. Conclusions: The model provides robust estimates of the costs and outcomes of MDA and usual care and can be used by decision-makers for planning and implementing scabies control programmes. Results of our analysis suggest that single-dose ivermectin MDA is cost-effective in scabies control and can be initiated at a scabies prevalence >10%.

Coverage of community-wide mass drug administration platforms for soil-transmitted helminths in Benin, India, and Malawi: findings from the DeWorm3 project.

BACKGROUND: Soil-transmitted helminths (STH) affect approximately 1.5 billion people globally. The current STH control strategy is annual or twice-annual preventive chemotherapy, typically school-based deworming targeting children and women of reproductive age. Mathematical modeling suggests that it may be possible to interrupt STH transmission through high-coverage community-wide mass drug administration (cMDA). DeWorm3 is a cluster randomized trial testing cMDA for prevalence reduction and transmission interruption. The purpose of this study is to describe coverage of cMDA in study clusters over time and correlates of coverage at individual and cluster levels. METHODS: From 2018-2020, DeWorm3 delivered six rounds of cMDA with 400 mg albendazole at sites in Benin, India, and Malawi. We report coverage, treatment uptake, and directly observed therapy across all rounds. Factors associated with coverage at the cluster level were identified using binomial generalized estimating equations, while factors associated with non-treatment at the individual level were identified using binomial mixed-effects models. RESULTS: Coverage was high across all clusters and rounds, exceeding the WHO target of 75% in all sites and across all rounds (78% to 95%); cluster-level coverage tended to increase over time. Younger, unmarried, and migratory adults were more likely to be untreated at all sites; adult males were more likely to be untreated in Benin and Malawi. Among children, girls were more likely to be untreated, as were non-school-attending and migratory children. Higher adult education was associated with greater odds of non-treatment among adults, but lower odds among children in the household. Belonging to a less wealthy or minority language-speaking household was associated with non-treatment among both adults and children. CONCLUSIONS: It is possible to deliver community-wide MDA with high coverage. Unique individual and community-level factors influence treatment across settings, and these may be addressed through targeted programming. TRIAL REGISTRATION: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH), NCT03014167.

Cost and budget impact of mass drug administration compared to expanded school-based targeted preventive chemotherapy for soil-transmitted helminth control in Zamboanga Peninsula, the Philippines.

Background: School-based targeted preventive chemotherapy (PC), the primary strategy for soil-transmitted helminth (STH) control, typically focusing on primary schoolchildren, was expanded to secondary school students in the Philippines in 2016. This program still excludes adults, who may also suffer from considerable morbidity and can be a significant reservoir of infection. Mass drug administration (MDA), where the entire population is treated, would bring additional health benefits but will also increase implementation costs. The incremental cost of implementing MDA for STH control compared to expanded school-based targeted PC, however, is unknown. Methods: A cost survey was conducted in Zamboanga Peninsula region in 2021 to estimate the economic and financial cost of implementing MDA compared to the expanded school-based targeted PC from a government payer perspective. A budget impact analysis was conducted to estimate the financial cost to the government of implementing MDA over a five-year timeframe. Monte Carlo simulation accounted for uncertainty in cost estimates. Costs were reported in 2021 United States Dollars ($). Findings: The economic cost of MDA was $809,000 per year (95% CI: $679,000-$950,000) or $0.22 per person targeted (95% CI: $0.19-$0.26), while the expanded school-based targeted PC would cost $625,000 (95% CI: $549,000-$706,000) or $0.57 per person targeted (95% CI: $0.50-$0.64). Over five years, the financial cost to the government for MDA would be $3,113,000 (95% CI: $2,475,000-$3,810,000); $740,000 (95% CI: $486,000-$1,019,000) higher than expanded school-based targeted PC. Interpretation: Implementing MDA in the region will increase the economic and financial costs by 29% and 31%, respectively, when compared to expanded school-based targeted PC. Implementing MDA would require the Department of Health to increase their total expenditure for STH control by 0.2% and could be key in addressing the ongoing STH burden. Funding: The project was funded by the Australian Centre for the Control and Elimination of Neglected Tropical Diseases (NHMRC GA19028), and JPCDT was supported by a UNSW Scientia PhD Scholarship. SVN is funded by an NHMRC Investigator Grant (APP 2018220).

Real-World Prescription Data for Intrathecal Drug Delivery: A Retrospective Analysis in 32,784 Patients.

OBJECTIVES: Currently, there are three monotherapy drugs approved by the United States Food and Drug Administration (FDA) for use in intrathecal drug delivery systems (IDDS): morphine, ziconotide, and baclofen. In practice, use includes alternate drugs, drug combinations, and drug concentrations. There is a paucity of real-world data examining prescription patterns for IDDS. Our analysis explores a one-year sample of prescription intrathecal (IT) medications from a large pharmaceutical data base to characterize medication usage in IDDS. MATERIALS AND METHODS: Data were provided by an accredited pharmacy as a deidentified data base of IT drug prescriptions. Statistical analyses included rates of monotherapy vs combination therapies, frequencies of various IT prescriptions, use of on- vs off-label medications, and opioid vs nonopioid formulations. RESULTS: Data were extracted from February 1, 2021 to February 14, 2022. No patients were excluded. The initial sample comprised 49,917 individual IT prescriptions for 32,784 patients. Monotherapies constituted 55.0% of all prescriptions (27,475/49,917). Of these, 23,257 prescriptions (84.6%) were opioid based, with the most common medications being morphine (46.5%), hydromorphone (39.4%), and fentanyl (13.5%). Although 29.3% of all prescriptions were for one of the FDA-approved medications, only 7.9% used FDA-approved concentrations; 9865 patients underwent ≥one prescription change in the study period-16.7% of whom were initially prescribed medications that met the approved, on-label indications for the pump before being switched to off-label concentrations or combinations to address clinical needs. CONCLUSIONS: Despite the prevalence of IDDS for managing chronic, intractable pain, minimal data exist on real-world prescription practices. Our study found that FDA-approved IT formulations accounted for the minority of prescriptions, indicating significant practice variation, with off-label prescriptions being common.

Nanorepair medicine for treatment of organ injury.

Organ injuries, such as acute kidney injury, ischemic stroke, and spinal cord injury, often result in complications that can be life-threatening or even fatal. Recently, many nanomaterials have emerged as promising agents for repairing various organ injuries. In this review, we present the important developments in the field of nanomaterial-based repair medicine, herein referred to as 'nanorepair medicine'. We first introduce the disease characteristics associated with different types of organ injuries and highlight key examples of relevant nanorepair medicine. We then provide a summary of existing strategies in nanorepair medicine, including organ-targeting methodologies and potential countermeasures against exogenous and endogenous pathologic risk factors. Finally, we offer our perspectives on current challenges and future expectations for the advancement of nanomedicine designed for organ injury repair.

Xenotransplantation Literature Update December 2023-June 2024.

This updated report highlights significant developments in the field of xenotransplantation since December 2023. Over the past 6 months, there has been a notable increase in discussions regarding the feasibility of clinical trials, with particular emphasis on their progression and associated ethical considerations. This review presents the most pertinent findings from December 2023 to June 2024.

MEIBO (perfluorohexyloctane): a novel approach to treating dry eye disease.

Dry eye disease (DED) or keratoconjunctivitis sicca (KCS) is a multifactorial disease that classically develops due to the hyperosmolarity of the tear film. Categorically divided into two types, based on decreased production and increased evaporation of the tear film, DED begins with a spectrum of nonspecific symptoms like pruritus, redness, burning and discomfort, progressively leading to stringy mucus eye discharge, photophobia, twitching, visual fluctuations, and punctate epithelial lesions. This disease has numerous treatment options, including medications, artificial tear inducers, and surgical manoeuvres that prevent water loss from the tear film. However, each of these treatment options has its limitations. The Food and Drug Administration (FDA) has approved another intervention, Meibo (perfluorohexyloctane), as a choice of management for dry eye disease. With its shielding action on the ocular surface, Meibo (perfluorohexyloctane) reduces desiccation stress-induced ocular damage, making it highly specific for treating DED. Available in an eye drop formulation of perfluorohexyloctane (PFHO), these drops can reduce saline evaporation by up to 80%. The methods we used for this analysis are literature searches from PubMed, Medline and Google Scholar. This study aims to scour varying differentials of DED, its aetiology, general interventions, the latest refinements, and clinical efficacy, safety, and trials associated with Meibo (perfluorohexyloctane) in the management of DED.

Disability in childhood and the equity of health services: a cross-sectional comparison of mass drug administration strategies for soil-transmitted helminths in southern Malawi.

BACKGROUND: School-based approaches are an efficient mechanism for the delivery of basic health services, but may result in the exclusion of children with disabilities if they are less likely to participate in schooling. Community-based 'door to door' approaches may provide a more equitable strategy to ensure that children with disabilities are reached, but disability is rarely assessed rigorously in the evaluation of health interventions. OBJECTIVES: To describe the prevalence and factors associated with disability among children aged 5-17 years and to assess the relative effectiveness of routine school-based deworming (SBD) compared with a novel intervention of community-based deworming (CBD) in treating children with disabilities for soil-transmitted helminths. SETTING: DeWorm3 Malawi Site (DMS), Mangochi district, Malawi. PARTICIPANTS: All 44 574 children aged 5-17 years residing within the DMS. PRIMARY AND SECONDARY OUTCOME MEASURES: Disability was defined as a functional limitation in one or more domains of the Washington Group/UNICEF Child Functioning Module administered as part of a community-based census. Treatment of all children during SBD and CBD was independently observed and recorded. For both intervention types, we performed bivariate analyses (z-score) of the absolute proportion of children with and without disabilities treated (absolute differences (ADs) in receipt of treatment), and logistic regression to examine whether disability status was associated with the likelihood of treatment (relative differences in receipt of treatment). RESULTS: The overall prevalence of disability was 3.3% (n=1467), and the most common domains of disability were hearing, remembering and communication. Boys were consistently more likely to have a disability compared with girls at all age groups, and disability was strongly associated with lower school attendance and worse levels of education. There was no significant difference in the proportion of children with disabilities treated during SBD when assessed by direct observation (-1% AD, p=0.41) or likelihood of treatment (adjusted risk ratio (aRR)=1.07, 95% CI 0.89 to 1.28). Treatment of all children during CBD was substantially higher than SBD, but again showed no significant difference in the proportions treated (-0.5% AD, p=0.59) or likelihood of treatment (aRR=1.04, 95% CI 0.99 to 1.10). CONCLUSION: SBD does not appear to exclude children with disabilities, but the effect of consistently lower levels of educational participation of children with disabilities should be actively considered in the design and monitoring of school health interventions. TRIAL REGISTRATION NUMBER: NCT03014167.

Personalized nutrition: aligning science, regulation, and marketing.

Interest in personalized nutrition among researchers and industry has grown rapidly in recent years and shows no signs of abating. In this paper, we discuss the growth of the personalized nutrition market, the evidence for the approach, and the regulatory landscape for personalized nutrition products. We found that regulatory gaps have led to market growth of products with unknown efficacy that are making bold, and possibly unsubstantiated, claims. As personalized nutrition products and related treatments continue to enter the market without regulation, unreliable products may cause consumers financial, psychological, and physical harm. Stronger regulation will help engender trust in these products among consumers and ensure their safety and effectiveness.

Tobacco and Nicotine Products Adverse Health Events: Findings From the FDA Safety Reporting Portal.

Introduction: The FDA oversees regulatory aspects of all U.S. tobacco products. Understanding the impact of emerging health trends and incidents associated with various tobacco and nicotine products is vital for public health. This study utilizes the FDA's Tobacco Product Problem Reports (TPPRs) to characterize and track adverse health events (AHEs) associated with tobacco and nicotine products over time, considering the impact of EVALI and the COVID-19 pandemic. Methods: FDA TPPRs from 2017-2022 provided information on AHEs related to various tobacco products. After data cleaning, 839 reports were categorized by two independent coders based on affected health category, frequency of AHEs reports, and proportion of AHEs per each health category. Additionally, variations in AHEs over time were assessed, considering major health events like EVALI and the COVID-19 pandemic. Results: Among the 839 reports, electronic cigarettes (e-cigarettes) were the primary product of concern, comprising 90.6% (n = 760) of all reports, surpassing traditional cigarettes (5.1%; n = 43) and other products. Notably, 45.6% of reports (n = 383) identified the neurological system as the most frequently mentioned health category, each reporting at least one AHE. This was followed by the respiratory (39.1%; n = 328) and digestive (10.7%; n = 90) systems. Among all reported AHEs, respiratory system issues were most frequent (25.9%; n = 512), closely followed by neurological (25.2%; n = 499) and digestive (6.6%; n = 131) concerns. Most reports occurred in 2019 (65.7%; n = 551), coinciding with the EVALI outbreak, with a subsequent decline post-Q3 2019, highlighting the potential impact of specific health crises on reporting trends. Conclusion: E-cigarettes dominated adverse health reports, particularly affecting the neurological and respiratory systems, with a peak in 2019. Our findings provide insights to regulatory entities and future research, enhancing understanding of AHEs in lesser-explored bodily systems, such as the neurological and digestive systems. This study emphasizes the need for ongoing and improved surveillance of emerging tobacco products to protect public health.

Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study.

Objective: This study aimed to validate the newly developed composite acceptability endpoint to investigate acceptability of oral pediatric drug formulations that integrates swallowability and palatability assessments. Methods: In this open-label study acceptability of oral formulations was tested in three age groups (1-<6 months, 6-<12 years, and 12-<18 years) with a 2-way cross-over design in children aged 1-<6 months (syrup and mini-tablets), and with an incomplete block design of four sequences with three out of four formulations (syrup, mini-tablets, oblong tablet, and round tablet) each in children aged 6-<18 years. The primary endpoint was acceptability derived from the composite acceptability endpoint. Secondary endpoints were palatability and acceptability derived from swallowability. Results: A total of 320 children were stratified into three age groups (80 children aged 1-<6 months, 120 children aged 6-<12 years, and 120 children aged 12-<18 years). All participants completed the study. Age-specific differences were observed in acceptability derived from the composite acceptability endpoint. Mini-tablets had the highest acceptability in participants aged 1-<6 months and 6-<12 years while the oblong tablet was leading in adolescent participants (12-<18 years). Conclusion: This study demonstrated that the composite acceptability endpoint method integrating both swallowability and palatability assessments is a sensitive method to assess acceptability of drug formulations in children of different age. Clinical Trial Registration: https://drks.de/search/de, identifier DRKS00027948.

Comparative Effectiveness of Bacillus Calmette-Guérin and Sequential Intravesical Gemcitabine and Docetaxel for Treatment-naïve Intermediate-risk Non-muscle-invasive Bladder Cancer.

BACKGROUND AND OBJECTIVE: Sequential intravesical gemcitabine/docetaxel (Gem/Doce) has emerged as a potential alternative to bacillus Calmette-Guérin (BCG) for the treatment of non-muscle-invasive bladder cancer (NMIBC). Our aim was to determine the comparative effectiveness of BCG and Gem/Doce for patients with intermediate-risk (IR) NMIBC, composed mainly of high-grade (HG) Ta disease. METHODS: Patients with IR-NMIBC who received either BCG or Gem/Doce during 2013-2023 were included. Maintenance BCG (as per the Southwest Oncology Group protocol) and monthly Gem/Doce maintenance for 1 yr were offered to patients with no evidence of recurrence after induction. Routine surveillance with cystoscopy was performed according to the American Urological Association guidelines. The Kaplan-Meier method was used to assess high-grade and any-grade recurrence-free survival (RFS). Cox regression analysis was performed to find predictors of recurrence. KEY FINDINGS AND LIMITATIONS: Of 483 patients, 127 had IR-NMIBC; 66 patients received BCG and 61 received Gem/Doce. Median age was 69 yr (interquartile range [IQR] 61-76) for the BCG group and 72 yr (IQR 62-76) for the Gem/Doce group. Median follow-up was 53.1 mo (IQR 25.3-71.2) for the BCG group and 20.2 mo (IQR 8.28-33.1) for the Gem/Doce group. The 2-yr high-grade RFS rates for primary high-grade tumors for BCG versus Gem/Doce groups were 81% versus 61%, with corresponding any-grade RFS rates of 60% versus 41%. Induction with Gem/Doce predicted any-grade recurrence (hazard ratio [HR] 1.87, 95% confidence interval [CI] 1.1-3.2) and high-grade recurrence for primary high-grade tumors (HR 3.4 95% CI 1.27-9.13), while receipt of maintenance therapy decreased the risk of any-grade recurrence (HR 0.4, 95% CI 0.22-0.72). This study is limited by its retrospective design. CONCLUSIONS AND CLINICAL IMPLICATIONS: For patients with IR-NMIBC, BCG was associated with superior any-grade RFS and high-grade RFS for primary high-grade tumors. Maintenance therapy was associated with better RFS when receiving Gem/Doce. Standardization and longer maintenance therapy protocols should be considered for Gem/Doce treatment. PATIENT SUMMARY: We compared outcomes for patients who received two different in-bladder treatments for intermediate-risk bladder cancer. Bacillus Calmette-Guérin (BCG) led to better outcomes than gemcitabine + docetaxel (Gem/Doce). Monthly maintenance therapy improved recurrence-free survival for patients who received Gem/Doce. We conclude that maintenance therapy is essential for patients receiving Gem/Doce to avoid bladder cancer recurrence after treatment.

The effect of education provided with the escape room game on nursing students' learning of parenteral drug administration.

AIM: The present study was conducted to determine the effect of education provided to first-year nursing students with the escape room game on their learning of parenteral drug administration. BACKGROUND: The use of escape room games in education supports formal education in providing students with professional knowledge and skills. DESIGN: A randomized controlled study design was used in this study. METHOD: The current study was conducted with 72 first-year nursing students. Data were collected with the Descriptive Characteristics Questionnaire (DCQ), Parenteral Drug Administration Information Test (PDAIT), Parenteral Drug Administration Sub-Checklists (PDASC) and Game Evaluation Form (GEF) between May and June 2022. The initial knowledge and skills of all students participating in the study were measured after completing the parenteral drug administration theoretical course and laboratory skills course. Students were assigned to the intervention (n=36) and control (n=36) groups by the stratified block randomization method according to their initial knowledge and skill measurements. Unlike the control group, the intervention group played the escape room game once in groups of four. The control group was allowed to work freely in the laboratory during this period. The final knowledge and skills of the intervention and control groups were measured immediately after the intervention. Students' skills were measured with an objective structured clinical examination. RESULTS: It was determined that the post-test knowledge level of the students in the intervention group and their post-test skill mean scores for drug withdrawal from an ampoule, subcutaneous injection administration, intradermal injection administration and intravenous push drug administration were higher than those of the students in the control group (p<0.05). Additionally, Intervention group students evaluated the escape room game positively. CONCLUSION: This study concluded that the escape room game supported formal education and could be used in teaching parenteral drug administration.

Investigation of P. vivax elimination via mass drug administration: A simulation study.

Plasmodium vivax is the most geographically widespread malaria parasite. P. vivax has the ability to remain dormant (as a hypnozoite) in the human liver and subsequently reactivate, which makes control efforts more difficult. Given the majority of P. vivax infections are due to hypnozoite reactivation, targeting the hypnozoite reservoir with a radical cure is crucial for achieving P. vivax elimination. Stochastic effects can strongly influence dynamics when disease prevalence is low or when the population size is small. Hence, it is important to account for this when modelling malaria elimination. We use a stochastic multiscale model of P. vivax transmission to study the impacts of multiple rounds of mass drug administration (MDA) with a radical cure, accounting for superinfection and hypnozoite dynamics. Our results indicate multiple rounds of MDA with a high-efficacy drug are needed to achieve a substantial probability of elimination. This work has the potential to help guide P. vivax elimination strategies by quantifying elimination probabilities for an MDA approach.

Prospective acceptability of mass drug administration for malaria in Kedougou region in Senegal: a mixed method study.

BACKGROUND: In Senegalese high-burden regions, the existing package of interventions is insufficient to reach the malaria elimination goal. Asymptomatic carriers of Plasmodium contribute significantly to malaria persistence and are not targeted by current interventions. The systematic treatment of all individuals in a community (mass drug administration, MDA) is a relevant intervention to tackle asymptomatic infections. The intervention can only be effective with a high participation of the population and, therefore, depends largely on its acceptability. This study aims to investigate the prospective acceptability of MDA in the Kedougou region to inform its potential use in a future strategy. METHODS: Following a 7-construct theoretical framework, prospective acceptability of MDA implemented in the rainy season was studied. In four villages, a sequential mixed design, from qualitative to quantitative, was used. In November 2021, interviews with healthcare professionals and focus groups with villagers were conducted. Findings from thematic analysis informed the development of a questionnaire administered to individuals aged ≥ 15 years in March 2022. Based on the questionnaire, an acceptability score was constructed and associations with socio-demographic factors were investigated using a linear mixed model. RESULTS: The 7 interviews, the 12 focus groups, and the questionnaire administered to 289 individuals demonstrated a good acceptability of MDA. Two potential barriers were identified: the contradiction of taking a medication without feeling sick and the occurrence of side effects; and four facilitators: the perception of malaria as a burden, a good understanding of MDA, a good perceived effectiveness, and the resulting economic benefits. The average acceptability score was 3.5 (range from -7 to + 7). Young adults aged 15 to 21 had a lower acceptability score compared to the other age groups, indicating an additional barrier to acceptability (ß = -0.78 [-1.67;0.1]). CONCLUSION: MDA is a priori acceptable to communities of Kedougou region in Senegal. Sensitization campaigns co-constructed with the communities, especially targeting young adults, are essential to ensure good acceptability.

A Retrospective Analysis of Intravenous Push versus Extended Infusion Meropenem in Critically Ill Patients.

Meropenem is a broad-spectrum antibiotic used for the treatment of multi-drug-resistant infections. Due to its pharmacokinetic profile, meropenem's activity is optimized by maintaining a specific time the serum concentration remains above the minimum inhibitory concentration (MIC) via extended infusion (EI), continuous infusion, or intermittent infusion dosing strategies. The available literature varies regarding the superiority of these dosing strategies. This study's primary objective was to determine the difference in time to clinical stabilization between intravenous push (IVP) and EI administration. We performed a retrospective pilot cohort study of 100 critically ill patients who received meropenem by IVP (n = 50) or EI (n = 50) during their intensive care unit (ICU) admission. There was no statistically significant difference in the overall achievement of clinical stabilization between IVP and EI (48% vs. 44%, p = 0.17). However, the median time to clinical stability was shorter for the EI group (20.4 vs. 66.2 h, p = 0.01). EI administration was associated with shorter hospital (13 vs. 17 days; p = 0.05) and ICU (6 vs. 9 days; p = 0.02) lengths of stay. Although we did not find a statistically significant difference in the overall time to clinical stabilization, the results of this pilot study suggest that EI administration may produce quicker clinical resolutions than IVP.