Cost-effectiveness Evaluation Research Articles

The evolution of BRAF-targeted therapies in melanoma: overcoming hurdles and unleashing novel strategies

Melanoma, a highly aggressive form of skin cancer, poses a significant global health burden, with 331,647 new cases and 58,645 deaths reported in 2022. The development of melanoma is influenced by various factors, including sunlight exposure and BRAFV600 mutations that activate the MAPK/ERK pathway. The introduction of BRAF and MEK inhibitors has revolutionized the treatment landscape for melanoma patients. However, innate and acquired therapeutic resistance remains a significant challenge. This review provides a comprehensive overview of the current state of BRAF-targeted therapies in melanoma, highlighting the efficacy and limitations of FDA-approved combinations of BRAF and MEK inhibitors such as vemurafenib, dabrafenib, trametinib, and cobimetinib. The review also explores the off-target effects of BRAF inhibitors on endothelial cells, emphasizing the need for more selective therapies to minimize vascular complications and metastatic potential. The article also discusses potential druggable targets, including ERK5, CD73, ALDH1A1, PLA1A, and DMKN, which are promising in addressing diagnostic hurdles and guiding personalized therapeutic decisions. Recent studies on regorafenib, ERK5 signaling, and CD73 inhibition are highlighted as novel strategies to overcome resistance and improve treatment outcomes. The review also delves into the role of advanced therapeutic tools, such as mRNA vaccines and CRISPR-Cas9, in revolutionizing personalized oncology by targeting specific genetic mutations and enhancing immune responses against melanoma. The ongoing synergy between advancing research, targeted interventions, strategic treatment combinations, and cost-effectiveness evaluations offers a promising pathway to elevate patient outcomes in the persistent battle against melanoma significantly.

Effectiveness of a Bullying Intervention (Be-Prox) in Norwegian Early Childhood and Education Care Centers: Protocol for a Cluster Randomized Controlled Trial.

A new and growing body of research has studied bullying among children in early childhood education and care centers (ECECs). The Bernese Program (Be-Prox) is designed to systematically prevent and handle bullying between children in Swiss ECECs. However, the effectiveness of the Be-Prox intervention has not yet been explored in a Norwegian ECEC setting. This study aims to evaluate the effectiveness of Be-Prox in preventing and handling bullying among peers in Norwegian ECECs. ECECs from 2 Norwegian municipalities were invited to participate in a cluster randomized controlled trial (RCT) to evaluate the effectiveness of the Be-Prox intervention on peer bullying in Norwegian ECECs. After baseline measures were taken, project ECECs were randomized to either an intervention or a control arm. The Be-Prox intervention was introduced to ECECs in the intervention arm through 6 modules over a 9-month period immediately after the randomization. ECECs in the control arm participated in the data collection and were offered the Be-Prox intervention the following year. The primary outcome of the effect evaluation is the mean sum of negative behavior between peers after the Be-Prox training is completed in the intervention arm. Secondary outcomes include child bystander behavior, teacher self-efficacy, and ECEC's authoritative climate. An extensive implementation and process evaluation, as well as cost-effectiveness analyses, will be conducted alongside the RCT. Baseline data collection was conducted in September 2023, and the postintervention data collection started in May 2024. At baseline, we collected data on 708 children and 413 personnel from 38 project ECECs in the 2 Norwegian municipalities. The results from the study will be available in late 2024 at the earliest. The proposed project includes a comprehensive evaluation of the effectiveness of Be-Prox in Norwegian ECECs directly targeting the prevention and handling of bullying, including implementation and cost-effectiveness evaluations. The results from the project have the potential to fill in identified knowledge gaps in the understanding of negative behavior and bullying between peers in ECECs, and how these may be prevented. If proven efficient, our ambition is to offer Be-Prox to Norwegian ECECs as an evidence-based practice to prevent and handle bullying among preschool children. ClinicalTrials.gov NCT06040437; https://clinicaltrials.gov/study/NCT06040437. DERR1-10.2196/60626.

A methodological guide for implementing and interpreting results of probabilistic analysis.

Probabilistic analysis, also referred to as probabilistic sensitivity analysis (PSA), is used extensively in cost-effectiveness evaluations of health technologies. We present methodological guidance for implementing probabilistic analysis and interpreting its results for policy and decision-making. We review the methodological issues related to common practices in probabilistic analysis, explore aspects that are currently not widely addressed in the health economics literature, and provide an overview of recent methodological developments. We use examples to highlight the advantages and disadvantages of common tools used for presenting probabilistic analysis results, including the cost-effectiveness acceptability curve (CEAC), cost-effectiveness acceptability frontier (CEAF), and value of information (VOI) analysis. We raise and address issues related to using Monte Carlo standard error to determine the number of iterations required, the implications of large uncertainty, and the credibility and meaningfulness of small differences in quality-adjusted life-years (QALYs). We then discuss evolving methods in probabilistic analysis, cautious uses of probabilistic analysis, and factors impacting parameter uncertainty. A deeper understanding of probabilistic analysis methods enables health economists and decision-makers to more effectively address and interpret parameter uncertainty in health economic evaluations, which is essential for making informed policy decisions.

Economic Burden of Community-Acquired Antibiotic-Resistant Urinary Tract Infections: Systematic Review and Meta-Analysis.

Antibiotic resistance (ABR) poses a major burden to global health and economic systems. ABR in community-acquired urinary tract infections (CA-UTIs) has become increasingly prevalent. Accurate estimates of ABR's clinical and economic burden are needed to support medical resource prioritization and cost-effectiveness evaluations of urinary tract infection (UTI) interventions. This study aims to systematically synthesize the evidence on the economic costs associated with ABR in CA-UTIs, using published studies comparing the costs of antibiotic-susceptible and antibiotic-resistant cases. We searched the PubMed, Ovid MEDLINE and Embase, Cochrane Review Library, and Scopus databases. Studies published in English from January 1, 2008, to January 31, 2023, reporting the economic costs of ABR in CA-UTI of any microbe were included. Independent screening of titles/abstracts and full texts was performed based on prespecified criteria. A quality assessment was performed using the Integrated Quality Criteria for Review of Multiple Study Designs (ICROMS) tool. Data in UTI diagnosis criteria, patient characteristics, perspectives, resource costs, and patient and health economic outcomes, including mortality, hospital length of stay (LOS), and costs, were extracted and analyzed. Monetary costs were converted into 2023 US dollars. This review included 15 studies with a total of 57,251 CA-UTI cases. All studies were from high- or upper-middle-income countries. A total of 14 (93%) studies took a health system perspective, 13 (87%) focused on hospitalized patients, and 14 (93%) reported UTI pathogens. Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa are the most prevalent organisms. A total of 12 (80%) studies reported mortality, of which, 7 reported increased mortality in the ABR group. Random effects meta-analyses estimated an odds ratio of 1.50 (95% CI 1.29-1.74) in the ABR CA-UTI cases. All 13 hospital-based studies reported LOS, of which, 11 reported significantly higher LOS in the ABR group. The meta-analysis of the reported median LOS estimated a pooled excess LOS ranging from 1.50 days (95% CI 0.71-4.00) to 2.00 days (95% CI 0.85-3.15). The meta-analysis of the reported mean LOS estimated a pooled excess LOS of 2.45 days (95% CI 0.51-4.39). A total of 8 (53%) studies reported costs in monetary terms-none discounted the costs. All 8 studies reported higher medical costs spent treating patients with ABR CA-UTI in hospitals. The highest excess cost was observed in UTIs caused by carbapenem-resistant Enterobacterales. No meta-analysis was performed for monetary costs due to heterogeneity. ABR was attributed to increased mortality, hospital LOS, and economic costs among patients with CA-UTI. The findings of this review highlighted the scarcity of research in this area, particularly in patient morbidity and chronic sequelae and costs incurred in community health care. Future research calls for a cost-of-illness analysis of infections, standardizing therapy-pathogen combination comparators, medical resources, productivity loss, intangible costs to be captured, and data from community sectors and low-resource settings and countries.

Effectiveness of Resmetirom in Reducing Cholesterol Levels in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis.

Nonalcoholic steatohepatitis (NASH) is a progressive form of nonalcoholic fatty liver disease (NAFLD) associated with metabolic syndrome and increased cardiovascular risk. Resmetirom, a novel liver-directed selective thyroid hormone receptor-β (THR-β) agonist, has shown promise in addressing both hepatic and systemic lipid metabolism. This systematic review and meta-analysis aimed to evaluate the efficacy of resmetirom in improving cholesterol levels in NASH patients. A systematic literature search was conducted across multiple databases including PubMed, Embase, Cochrane Library, andClinicalTrials.gov, identifying three randomized controlled trials for inclusion. The meta-analysis revealed that resmetirom significantly reduced low-density lipoprotein cholesterol (LDL-C) levels compared to placebo (MD: -23.62; 95% CI: -37.32 to -9.93; p < 0.001). Similarly, triglyceride (TG) levels showed a significant reduction in the resmetirom group (MD: -33.86; 95% CI: -47.79 to -19.92; p < 0.001). Importantly, there was no significant difference in the risk of serious adverse events between resmetirom and placebo groups (RR: 1.09; 95% CI: 0.73 to 1.63; p = 0.67). These findings suggest that resmetirom effectively improves lipid profiles in NASH patients without compromising safety. However, the analysis was limited by the small number of studies, all from the same research group, and high heterogeneity in results. Future research should include more diverse studies, longer follow-up periods, and cost-effectiveness evaluations. Despite these limitations, resmetirom shows promise as a potential treatment for managing dyslipidemia and cardiovascular risk in NASH patients, potentially influencing future treatment guidelines for both liver and cardiovascular health in this population.

Feasibility of a theory-based intervention towards benzodiazepine deprescribing in Belgian nursing homes: protocol of the END-IT NH cluster-randomised controlled trial

IntroductionDespite several calls to deprescribe benzodiazepine receptor agonists (BZRA) in older adults, their use among nursing home residents (NHRs) remains high. Therefore, we developed an intervention targeting general practitioners’ and...

Evaluation of long-term benefits and cost-effectiveness of nation-wide colorectal cancer screening strategies in China in 2020–2060: a modelling analysis

Evidence on the long-term benefits and cost-effectiveness of colorectal cancer (CRC) screening strategies in China remains limited. This modelling study aims to address this issue for various CRC screening strategies in China between 2020 and2060. Using a previously developed microsimulation model (MIMIC-CRC) with Chinese epidemiological data, we evaluated four CRC screening strategies targeting population aged 45-74 years: no screening, colonoscopy every 10years, biennial faecal immunochemical testing (FIT), and a roll-out FIT screening strategy. Screening coverage (invitation) rates from 5% to 100% were analysed. Single-cohort analysis of 100,000 individuals was conducted to estimate the relative cost-effectiveness of each strategy. A multiple-cohort analysis of 100,000 people aged 40+ over 2020-2060 was conducted to project nation-wide long-term benefits and cost-effectiveness. In single-cohort analysis, all strategies yielded reductions in CRC incidence and mortality compared to no screening, with colonoscopy outperforming FIT-based strategies at the same invitation rates. In multiple-cohort analysis, among people over 40 years of age in China over 2020-2060, compared to no screening, at invitation rate of 5%, screening by colonoscopy, biennial FIT and roll-out FIT-based approach were estimated to avert 1.2, 0.4, and 0.3 million incident CRCs and 0.2, 0.1, and 0.1 million CRC-related deaths, respectively, compared to no screening (25.4 million incident CRCs and 4.4 million CRC-related deaths), and this preventive effect enlarged as the screening coverage rate increased. At full coverage, colonoscopy achieved the largest reductions (38.2% lower incidence and 43.2% lower mortality) but required the most resources. Biennial FIT and roll-out FIT-based approach screening was slightly less effective but had significant reduced colonoscopy needs (reduction of 83.8% and 85.2%, respectively) and overall cost (reduction of 23.4% and 37.8%, respectively) compared to colonoscopy screening. Nation-wide implementation of screening would be effective in reducing the burden of CRC in China. Biennial FIT and roll-out FIT-based screening strategies could prevent incident CRC cases and CRC-related deaths with considerably fewer resources than colonoscopy screening. Efforts should be made to increase the screening coverage in China. Chinese Academy of Medical Science Innovation Fund for Medical Science (2022-I2M-1-0031); National Natural Science Foundation of China (82173606; 82273726); Beijing Nova Program of Science and Technology (20230484397).

Systemic reviews and meta-analysis of the use of midodrine in hepatorenal syndrome

Aims. This study analyzes the effectiveness of midodrine in reducing or managing Hepatorenal Syndrome (HRS). Design. A systematic review and meta-analysis were conducted to gather and assess relevant literature. The review included evaluating study aims, methodologies, outcomes, and implications, with data presented in a tabular format for clarity. The protocol specified the search strategy, selection criteria, and data extraction methods for transparency. Data sources. Articles were sourced from Google Scholar and PubMed using inclusion and exclusion criteria. Quality assessment data were extracted, synthesized, analyzed, and reported. Review methods. The systematic review focused on peer-reviewed journals, considering factors such as time, language, and full-length article availability. Studies were excluded if they were duplicates, abstracts only, or non-English. Results. Midodrine was found to improve arterial pressure and renal function in HRS patients, suggesting a link between circulatory and renal functions. Sample sizes varied across studies, with some involving small patient groups. Terlipressin appeared more effective than midodrine and octreotide in improving renal function due to its impact on mean arterial pressure (MAP). Specific findings included significant increases in arterial pressure and renal function improvement in both treatment and control groups. Conclusion. Midodrine shows potential in managing HRS, decreasing nitrite and nitrate levels in ascites patients, and improving renal function. However, significant, well-designed clinical trials are needed to determine optimal dosage, duration, and pharmacological side effects. The meta-analysis highlights opportunities for further research on midodrine in combination treatments and cost-effectiveness evaluations. Impact. This study opens avenues for future research on midodrine's role in HRS treatment, particularly in combination therapies and cost-effectiveness studies.

A Machine Learning Approach for Efficiently Predicting Polymer Aging from UV-Vis Spectra.

This research has introduced an innovative approach that proficiently forecasts the alterations in ultraviolet-visible spectroscopy (UV-Vis) of polymer solutions during the aging effect. This method combines readily accessible feature descriptors with classical machine learning (ML) algorithms. Traditional spectral measurements, while precise in analyzing physical properties, are limited by their cost and efficiency. Therefore, this paper introduces a method that utilizes wavelength and the blue (B), green (G), and red (R) color values of the solutions as input features. We employed seven different ML models to train on these features with 10-fold cross-validation to ensure the reliability and generalizability of our results. After comparative analysis, all of the models performed excellently. Among them, the ExtraTree model demonstrated particularly high precision and excellent predictive ability on the testing set, with a Pearson correlation coefficient (r) of 0.9859 and a mean absolute error (MAE) of 0.0457. This study offers a practical solution for the rapid and cost-effective evaluation of polymer solutions' aging effect.

Radiograph accelerated detection and identification of cancer in the lung (RADICAL): a mixed methods study to assess the clinical effectiveness and acceptability of Qure.ai artificial intelligence software to prioritise chest X-ray (CXR) interpretation

IntroductionDiagnosing and treating lung cancer in early stages is essential for survival outcomes. The chest X-ray (CXR) remains the primary screening tool to identify lung cancers in the UK; however,...

The Use of Nudge Strategies in Improving Physicians' Prescribing Behavior: A Systematic Review and Meta-analysis.

Nudges have been proposed as a method of influencing prescribing decisions. The purpose of this article is to 1) investigate associations between nudges' characteristics and effectiveness, 2) assess the quality of the literature, 3) assess cost-effectiveness, and 4) create a synthesis with policy recommendations. We searched health and social science databases. We included studies that targeted prescribing decisions, included a nudge, and used prescribing behavior as the outcome. We recorded study characteristics, effect size of the primary outcomes, and information on cost-effectiveness. We performed a meta-analysis on the standardized mean difference of the studies' primary outcomes, tested for associations between effect size and key intervention characteristics, and created a funnel plot evaluating publication bias. We identified 21 studies containing 25 nudges. In total, 62 of 85 (73%) outcomes showed a statistically significant effect. The average effect size was -0.22 standardized mean difference. No studies included heterogeneity analyses. We found no associations between effects and selected study characteristics. Study quality varied and correlated with study design. A total of 7 of 21 (33%) studies included an evaluation of costs. These studies suggested that the interventions were cost-effective but considered only direct effects. We found evidence of publication bias. Heterogeneity and few studies limit the possibilities of statistical inference about effectiveness. Nudges may be effective at directing prescribing decisions, but effects are small and health effects and cost-effectiveness are unclear. Future nudge studies should contain a rationale for the chosen nudge, prioritize the use of high-quality study designs, and include evaluations of heterogeneity, cost-effectiveness, and health outcomes to inform decision makers. Moreover, preregistration of the protocol is warranted to limit publication bias. Nudging as a method to improve prescribing decisions has gained popularity during the past decade.We find that nudging can improve prescribing decisions, but effect sizes are mostly small, and the size of derived health outcomes is unclear.Most studies use feedback and error-stopping nudges to target excessive opioid or antibiotic prescribing, making heterogeneity analyses across nudge types difficult.Further research on the cost-effectiveness of nudges and generalizability is needed to guide decision makers considering nudging as a tool to guide prescribing decisions.

Effective Use and Cost-Evaluation of Erythrocyte Suspension in Surgical Branches of Tertiary Hospital

Blood has been accepted as the basic symbol of life from the past to the present. Transfusion is the transfer of blood and blood components to a patient due to various health problems. The present study aimed to evaluate the effective use and cost of erythrocyte suspension in surgical branches in a tertiary hospital. In this study, the use and cost-effective evaluation of erythrocyte suspension, a blood component, after surgical intervention in brain and nerve diseases surgery, orthopedics and traumatology, general surgery, gynecology and obstetrics, and organ transplantation clinics between 01/01/2023 and 12/31/2023 were retrospectively evaluated. Because blood products are provided as voluntary donations, their appropriate use will help reduce hospital and patient costs. We believe that strict compliance with national and international standards and guidelines, quality management, and good clinical practices, as well as ensuring continuity of training on these issues, will enable more efficient product acquisition and decrease blood component disposal in all blood services units.

Building performance modelling approaches for a detached vertical green trellis: A case study in a tropical climate

Passive strategies involving greenery significantly increase energy performance in buildings and comfortable microclimate conditions. However, few studies model and simulate their effect on buildings’ energy performance. Thus, this work assesses modelling approaches for conducting building performance simulations where detached vertical green trellises (DVGT) are included. The DVGT characteristics are modelled by: (i) large solid component blocks and (ii) small opaque solid component blocks to form a grid. A building with glazed façades is evaluated through dynamic simulation under the tropical climate of Panama City, using DesignBuilder. Parametric analysis is performed to study the impact of the trellis configuration on the performance in reducing the annual cooling, lighting, and total electricity consumption. A cost-effective evaluation is also conducted based on the net present value for each trellis configuration. Results showed strong agreement with previous studies reporting significant cooling needs reduction while increasing lighting needs and promising return periods. This concludes that the correct optical and radiative properties of the vegetation layer that are wanted to be modelled in a detached vertical trellis are crucial.

Early experience using vacuum-assisted closure for managing soft tissue injuries in open type IIIB tibial fractures, a non-randomised controlled trial from a North African level one trauma centre

Purpose: The primary objective was to investigate our early results of using vacuum-assisted closure (VAC) for wound management in patients with open IIIB tibial fractures and compare the results with a group subjected to conventional daily dressing. Methods: A prospective non-randomised clinical trial (NRCT) with a parallel design and allocation ratio of 1:1 was conducted after obtaining ethical committee approval. Forty skeletally mature patients with unilateral type IIIB open tibia fractures were included over two years, starting from April 2019. In group A, patients were treated with VAC, which was changed every four days if needed, and in group B, patients had daily conventional dressings. Results: Both groups had no differences in the basic demographic, comorbidities, injury mechanism, and associated injuries. The need for secondary debridement surgeries was significantly lower in Group A than in Group B, 1 ± 0.50 versus 2.50 ± 0.85, respectively ( P &lt; 0.001). The time till definitive coverage was significantly lower in Group A than in Group B, 12.22 ± 2.90 versus 23.56 ± 8.68 (days); P &lt; 0.001. All coverage procedures succeeded in Group A, while four (20%) failed in Group B, P = 0.04. Infection was higher in Group B, with six (30%) patients compared to one (5%) in Group A, P = 0.01. Conclusion: Reports on VAC's role in managing severe open fracture wounds are rare in our area, and the initial results we obtained are encouraging, with lower infection rates and less cumbersome reconstruction procedures; however, further evaluation of the procedure's cost-effectiveness is mandatory.

Cost, Cost-effectiveness and Survival Impact Assessment for A Better Management of Colorectal Cancer Patients: A Single Centre Comprehensive Analysis.

The world healthcare systems are currently challenged by the accumulating burden of colorectal cancer (CRC), and cancer registries represent an important segment for prevention and developing management plans, being useful in providing data regarding incidence, mortality, survival, exposure to carcinogens, lifestyle. Retrospective data from CRC patients in Romania was used to assess survival impact, costs, and cost-effectiveness considering three crucial aspects: pharmacology, chemo-/radio-therapy, and hospitalization for care and management of these patients. 423 CRC patients from the Institutional Cancer Registry of the Prof. Dr. Ion Chiricuta Institute of Oncology in Cluj-Napoca, Romania were included in the cost analysis. For the assessment of cost efficiency of the primary treatment strategy, we collected data regarding direct medical costs associated with surgery, radiotherapy and medication, as well as the afferent day or continuous hospitalization, for each patient. For the cost-effectiveness analysis we used the method of estimation of incremental cost-effectiveness ratio. No compelling differences regarding survival time were observed in different therapeutic options per CRC stage. Substantial differences in cost effectiveness among therapeutic options in the same stage of several thousand Euros in stages I-III, while for stage IV, the ICER was more than 100,000 Euros per life saved. Systematic evaluation of costs, cost-effectiveness, and survival impact, helps healthcare systems can make informed decisions to improve the management of colorectal cancer patients, optimizing outcomes while minimizing financial burden.

Trends in drug treatment of benign prostatic hyperplasia in Japan based on the National Database Open Data.

This study examined prescription trends for benign prostatic hyperplasia (BPH) drug therapy in Japan over the past decade, focusing on drugs rated as grade A according to Japanese clinical guidelines. Using the National Database Open Data, this study analyzed prescription data from the fiscal years of 2014 to 2021, tracking α1-blockers, 5α-reductase inhibitors, and phosphodiesterase type 5 inhibitors. We adjusted for demographics and calculated medication costs to determine prescribing patterns and changes in drug utilization. Prescriptions for α1-blockers increased from 9898 per 1000 males in 2014 to 12 613 in 2021. Prescriptions for 5α-reductase inhibitors rose from 1441 per 1000 males in 2014 to 2310 in 2021. Tadalafil prescriptions saw a significant increase, from 900 in 2015 to 2520 in 2021. Despite these increases, the overall market size for BPH drugs decreased from 664 million dollars in 2014 to 279 million dollars in 2021, indicating a shift toward generic medications driven by healthcare policies. Although BPH medication prescriptions are increasing, driven by Japan's aging population and clinical guidelines, market dynamics are shifting owing to generic and government price adjustments. This analysis underscores the changing BPH treatment landscape in Japan, highlighting the importance of continuous evaluation of treatment efficacy and cost-effectiveness in evolving healthcare policies and demographics.

516. HELLER MYOTOMY FOR SYMPTOMATIC ACHALASIA: TRADITIONAL LAPAROSCOPY OR ROBOTICS? A SYSTEMATIC REVIEW WITH META-ANALYSIS

Abstract Background Laparoscopic Heller myotomy (LH) has been established as the gold standard for symptomatic achalasia; robotic-assisted laparoscopic myotomy (RH) has shown promising outcomes regarding safety and effectiveness. We aim to meta-analyse data comparing LH and RH surgical outcomes and complications. Methods A systematic search was conducted in February 2024 without restrictions according to PRISMA guidelines in PubMed, Web of Science, Scopus, and Cochrane Register. Studies comparing laparoscopic and robotic approach for Heller myotomy in adults with symptomatic achalasia were included for systematic review. Meta-analysis was performed trough generalized linear mixed model in R 4.3.2. Results 16 observational studies, out of 273, were included; reporting on 15076 patients. No statistically differences in preop characteristics were noted. RH had significantly fewer intraoperative esophageal perforations (OR=7.29, p&amp;lt; 0.0001, 95%), fewer subsequent myotomies and endoscopic treatments for recurrence (OR= 3.64, p=0.01 and OR= 3.38, p=0.03) and better symptom score improvement (OR=0.507, p=0.04). Although not clinically significant, RH had shorter hospital stays (MD=0.45 days, p= 0.005,) and reduced intraoperative blood loss (MD=10.46 ml, p=0.0002). Although not statistically significant, RH had fewer bleeding episodes, lower conversion, reintervention and mortality rates, comparable morbidity and postoperative GERD and higher operative time. Conclusion This updated meta-analysis suggests that RH is associated with lower regarding perforations, recurrence rates and symptom improvement compared to LH, with negligible lengthening of operative times. RH for symptomatic achalasia represents a feasible treatment for symptomatic achalasia, with a satisfying safety and effectiveness profile. RCTs on the topic and about cost-effectiveness evaluations are necessary to support the reported data.

Development of Sensitive In Vitro Protocols for the Biocompatibility Testing of Medical Devices and Pharmaceuticals Intended for Contact with the Eyes: Acute Irritation and Phototoxicity Assessment.

This study introduces a novel in vitro methodology that employs the 3-D reconstructed tissue model, EpiOcular, to assess the irritation and phototoxicity potential of medical devices and drugs in contact with the eye. Our study evaluated diverse test materials, including medical devices, ophthalmological solutions and an experimental drug (cemtirestat), for their potential to cause eye irritation and phototoxicity. The protocols used in this study with the EpiOcular tissue model were akin to those used in the ultra-mildness testing of cosmetic formulations, which is challenging to predict with standard in vivo rabbit tests. To design these protocols, we leveraged experience gained from the validation project on the EpiDerm skin irritation test for medical devices (ISO 10993-23:2021) and the OECD TG 498 method for photo-irritation testing. The predictions were based on the tissue viability and inflammatory response, as determined by IL-1α release. By developing and evaluating these protocols for medical devices, we aimed to expand the applicability domain of the tests referred to in ISO 10993-23. This will contribute to the standardisation and cost-effective safety evaluation of ophthalmic products, while reducing reliance on animal testing in this field. The findings obtained from the EpiOcular model in the photo-irritation test could support its implementation in the testing strategies outlined in OECD TG 498.

Reporting standards to support cost-effectiveness evaluations of AI-driven health care

Reporting standards to support cost-effectiveness evaluations of AI-driven health care

Evaluation of Cost-Effectiveness of a Virtual Multidisciplinary Stroke Care Clinic for Community-Dwelling Survivors of Stroke.

A technologically integrated, multidisciplinary approach to stroke rehabilitation service was delivered and embedded into conventional health care practice. This article reports an evaluation of cost-effectiveness analysis of a new Virtual Multidisciplinary Stroke Care Clinic (VMSCC) service for community-dwelling survivors of stroke. A randomized controlled trial was conducted. Adults with a first/recurrent ischemic/hemorrhagic stroke were recruited from 10 hospitals. Eligible participants were randomly assigned to receive the VMSCC service (individual virtual consultations with a registered nurse, home blood pressure telemonitoring, and unlimited access to an online resource platform) plus usual care or usual care alone. Cost-effectiveness analyses were performed based on incremental cost-effectiveness ratios expressed as incremental cost per emergency admission reduced, and day of hospitalization reduced over the study period. A total of 256 participants (intervention group n=141 versus control group n=115) with complete cost and health care use data were included in the cost-effectiveness analyses. The VMSCC service, on average, resulted in a greater reduction in the number of emergency admission (-0.06 [95% bootstrapped CI, -0.14 to 0.01]) and fewer days of hospitalization (-0.08, [95% bootstrapped CI -0.40 to 0.24]) but incurred a higher total cost of HK$375 (95% bootstrapped CI, -2103 to 2743) compared with the usual care. The incremental cost-effectiveness ratios of the VMSCC service compared with the usual care were HK$6070 and HK$4826 per an emergency admission and a day of hospital stay reduced respectively. The study provides preliminary but not confirmative evidence that the VMSCC service could be more effective but more costly than usual care in reducing health service use. URL: https://www.chictr.org.cn. Unique identifier: ChiCTR1800016101.