Cost-effectiveness of medication therapy management among Medicare population and across racial/ethnic groups.

BACKGROUND: Inappropriate medication utilization among older adults is a pressing concern in the United States, owing to its high prevalence and the consequential detrimental impact it engenders. The adverse effects stemming from the inappropriate use of medication may be unequally borne by racial/ethnic minority populations, calling for greater efforts towards promoting equity in healthcare. The study objective was to assess the cost-effectiveness of Medication Therapy Management (MTM) services among Medicare beneficiaries and across racial/ethnic groups. METHODS: Medicare administrative data from 2016 to 2017 linked to Area Health Resources Files were used to analyze Medicare fee-for-service patients aged 65 or above with continuous Parts A/B/D coverage. The intervention group included new MTM enrollees in 2017; the control group referred to patients who met the general MTM eligible criteria but did not enroll in 2016 or 2017. The 2 groups were matched using a propensity score method. Effectiveness was evaluated as the proportion of appropriate medication utilization based on performance measures developed by the Pharmacy Quality Alliance. Costs were computed as total healthcare costs from Medicare perspective. A multivariable net benefit regressions with a classic linear model and Bayesian analysis were utilized. Net benefit was calculated based on willingness-to-pay thresholds at various multiples of the gross domestic product in 2017. Three-way interaction terms among dummy variables for MTM enrollment, 2017, and racial/ethnic minority groups were incorporated in a difference-in-differences study design. RESULTS: After adjusting for patient characteristics, the findings indicate that MTM receipt was associated with incremental net benefit among each race and ethnicity. For instance, the net benefit of MTM among the non-Hispanic White patients was $2498 (95% confidence interval = $1609, $3386) at a willingness-to-pay value of $59,908. The study found no significant difference in net benefits for MTM services between minority and White patients. CONCLUSION: The study provides evidence that MTM is a cost-effective tool for managing medication utilization among the Medicare population. However, MTM may not be cost-effective in reducing racial/ethnic disparities in medication utilization in the short term. Further research is needed to understand the long-term cost-effectiveness of MTM on racial/ethnic disparities.

Public health and economic benefits of seasonal influenza vaccination in risk groups in France, Italy, Spain and the UK: state of play and perspectives.

BACKGROUND: Seasonal influenza epidemics have a substantial public health and economic burden, which can be alleviated through vaccination. The World Health Organization (WHO) recommends a 75% vaccination coverage rate (VCR) in: older adults (aged ≥ 65 years), individuals with chronic conditions, pregnant women, children aged 6-24 months and healthcare workers. However, no European country achieves this target in all risk groups. In this study, potential public health and economic benefits achieved by reaching 75% influenza VCR was estimated in risk groups across four European countries: France, Italy, Spain, and the UK. METHODS: A static epidemiological model was used to estimate the averted public health and economic burden of increasing the 2021/2022 season VCR to 75%, using the efficacy data of standard-dose quadrivalent influenza vaccine. For each country and risk group, the most recent data on population size, VCR, pre-pandemic influenza epidemiology, direct medical costs and absenteeism were identified through a systematic literature review, supplemented by manual searching. Outcomes were: averted influenza cases, general practitioner (GP) visits, hospitalisations, case fatalities, number of days of work lost, direct medical costs and absenteeism-related costs. RESULTS: As of the 2021/2022 season, the UK achieved the highest weighted VCR across risk groups (65%), followed by Spain (47%), France (44%) and Italy (44%). Based on modelling, the 2021/2022 VCR prevented an estimated 1.9 million influenza cases, avoiding 375,200 GP visits, 73,200 hospitalisations and 38,400 deaths. To achieve the WHO 75% VCR target, an additional 24 million at-risk individuals would need to be vaccinated, most of which being older adults and patients with chronic conditions. It was estimated that this could avoid a further 918,200 influenza cases, 332,000 GP visits, 16,300 hospitalisations and 6,300 deaths across the four countries, with older adults accounting for 52% of hospitalisations and 80% of deaths. An additional €84 million in direct medical costs and €79 million in absenteeism costs would be saved in total, with most economic benefits delivered in France. CONCLUSIONS: Older adults represent most vaccine-preventable influenza cases and deaths, followed by individuals with chronic conditions. Health authorities should prioritise vaccinating these populations for maximum public health and economic benefits.

Cost-effectiveness of restorative treatments for permanent molars with severe molar incisor hypomineralization: perspectives for the Brazilian public health system.

OBJECTIVES: To undertake a cost-effectiveness analysis of restorative treatments for a first permanent molar with severe molar incisor hypomineralization from the perspective of the Brazilian public system. MATERIALS AND METHODS: Two models were constructed: a one-year decision tree and a ten-year Markov model, each based on a hypothetical cohort of one thousand individuals through Monte Carlo simulation. Eight restorative strategies were evaluated: high viscosity glass ionomer cement (HVGIC); encapsulated GIC; etch and rinse adhesive + composite; self-etch adhesive + composite; preformed stainless steel crown; HVGIC + etch and rinse adhesive + composite; HVGIC + self-etch adhesive + composite, and encapsulated GIC + etch and rinse adhesive + composite. Effectiveness data were sourced from the literature. Micro-costing was applied using 2022 USD market averages with a 5% variation. Incremental cost-effectiveness ratio (ICER), net monetary benefit (%NMB), and the budgetary impact were obtained. RESULTS: Cost-effective treatments included HVGIC (%NMB = 0%/ 0%), encapsulated GIC (%NMB = 19.4%/ 19.7%), and encapsulated GIC + etch and rinse adhesive + composite (%NMB = 23.4%/ 24.5%) at 1 year and 10 years, respectively. The benefit gain of encapsulated GIC + etch and rinse adhesive + composite in relation to encapsulated GIC was small when compared to the cost increase at 1 year (gain of 3.28% and increase of USD 24.26) and 10 years (gain of 4% and increase of USD 15.54). CONCLUSION: Within the horizon and perspective analyzed, the most cost-effective treatment was encapsulated GIC restoration. CLINICAL RELEVANCE: This study can provide information for decision-making.

Cost-effectiveness of additional serplulimab to chemotherapy in metastatic squamous non-small cell lung cancer patients.

Objective: To estimate the cost-effectiveness of adding serplulimab to chemotherapy for metastatic squamous non-small cell lung cancer (NSCLC) patients in a first-line setting from a Chinese perspective. Methods: A three-health state partitioned survival model was constructed to simulate disease development. The clinical data used in the model were derived from the ASTRUM-004 clinical trial. Only direct medical costs were included, and the utilities were derived from published literature. The quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were employed to evaluate health outcomes. Additionally, a sensitivity analysis was performed to verify the robustness of the results. Results: Compared with chemotherapy alone, the addition of serplulimab resulted in an increase of 0.63 QALYs with an incremental cost of $5,372.73, leading to an ICER of $8,528.14 per QALY. This ICER was significantly lower than 3 times China's per capita GDP. The one-way sensitivity analysis suggested that the utility of PFS was the most sensitive factor on ICERs, followed by the price of serplulimab. Conclusion: The combination of serplulimab and chemotherapy has been shown to be a cost-effective initial treatment option for patients with metastatic squamous NSCLC with the commonly accepted willingness-to-pay threshold of 3 times the GDP per capita per QALY in China.

Cost-effectiveness analysis of adult pneumococcal conjugate vaccines for pneumococcal disease in Japan.

BACKGROUND: The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is used in the Japanese National Immunization Program for older adults and adults with increased risk for pneumococcal disease, however, disease incidence and associated burden remain high. We evaluated the cost-effectiveness of pneumococcal conjugate vaccines (PCVs) for adults aged 65 years and high-risk adults aged 60-64 years in Japan. RESEARCH DESIGN AND METHODS: Using a Markov model, we evaluated lifetime costs using societal and healthcare payer perspectives and estimated quality-adjusted life-years (QALYs), and number of prevented cases and deaths caused by invasive pneumococcal disease (IPD) and non-IPD. The base case analysis used a societal perspective. RESULTS: In comparison with PPSV23, the 20-valent PCV (PCV20) prevented 127 IPD cases 10,813 non-IPD cases (inpatients: 2,461, outpatients: 8,352) and 226 deaths, and gained more QALYs (+0.0015 per person) with less cost (-JPY22,513 per person). All sensitivity and scenario analyses including a payer perspective analysis indicated that the incremental cost-effectiveness ratios (ICERs) were below the cost-effectiveness threshold value in Japan (JPY5 million/QALY). CONCLUSIONS: PCV20 is both cost saving and more effective than PPSV23 for adults aged 65 years and high-risk adults aged 60-64 years in Japan.

Analysis of the costs of teleconsultation for the treatment of diabetes mellitus in the SUS.

OBJECTIVE: To present the results of a cost analysis of remote consultations (teleconsultations) compared to in-person consultations for patients with type 2 diabetes, in the Brazilian public healthcare system (SUS) in the city of Joinville, Santa Catarina (SC). In addition to the costs from the local manager's perspective, the article also presents estimates from the patient's perspective, based on the transportation costs associated with each type of consultation. METHOD: Data were collected from 246 consultations, both remote and in-person, between 2021 and 2023, in the context of a randomized clinical trial on the impact of teleconsultation carried out in the city of Joinville, SC. Teleconsultations were carried out at Primary Health Units (PHU) and in-person consultations at the Specialized Health Center. The consultation costs were calculate by the method time and activity-based costing (TDABC), and for the estimate of transportation costs data was collected directly from the research participants . The mean costs and time required to carry out each type of consultation in different scenarios and perspectives were analyzed and compared descriptively. RESULTS: Considering only the local SUS manager's perspective, the costs for carrying out a teleconsultation were 4.5% higher than for an in-person consultation. However, when considering the transportation costs associated with each patient, the estimated value of the in-person consultation becomes 7.7% higher and, in the case of consultations in other municipalities, 15% higher than the teleconsultation. CONCLUSION: The results demonstrate that the incorporation of teleconsultation within the SUS can bring economic advantages depending on the perspective and scenario considered, in addition to being a strategy with the potential to increase access to specialized care in the public network.

Cost-effectiveness and cost-utility analyses of three different gargles in the treatment of chronic periodontitis.

OBJECTIVE: This study aimed to investigate the economics of three different gargles in the treatment of chronic periodontitis. METHODS: A total of 108 patients with periodontitis received one of the following three gargles: xipayi, compound chlorhexidine, or Kangfuxin gargle. The basic information of the patients, the costs of the gargles, the periodontal indexes before and after treatment, and the scores of the 3-level version of the EuroQol Five Dimensions Questionnaire were collected. The cost-effectiveness and cost-utility of the various gargles were determined. RESULTS: The cost-effectiveness ratios (CER) of the three groups after treatment were 1828.75, 1573.34, and 1876.92 RMB, respectively. The utility values before treatment were 0.92, 0.90, and 0.91, respectively, and the utility values after treatment were 0.98, 0.98, and 0.97, respectively. The cost-utility ratios (CURs) were 213.43, 195.61, and 301.53 RMB, respectively. CONCLUSIONS: For each increase in effective rate and quality-adjusted life years, the treatment cost of periodontitis patients was lower than the gross domestic product per capita of Jiangsu Province, indicating that the treatment cost is completely worth it. The CER and CUR results were the same, and the compound chlorhexidine group was the lowest, demonstrating that when the same therapeutic effect was achieved, it cost the least.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.

INTRODUCTION: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. METHODS AND ANALYSIS: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. TRIAL REGISTRATION NUMBER: ISRCTN16830506. PROTOCOL VERSION: 5.0, 10 Oct 2023.

Is implementation of robotic-assisted procedures in acute care general surgery cost-effective?

Over the past 2 decades, the use and importance of robotic surgery in minimally invasive surgery has increased. Across various surgical specialties, robotic technology has gained popularity through its use of 3D visualization, optimal ergonomic positioning, and precise instrument manipulation. This growing interest has also been seen in acute care surgery, where laparoscopic procedures are used more frequently. Despite the growing popularity of robotic surgery in the acute care surgical realm, there is very little research on the utility of robotics regarding its effects on health outcomes and cost-effectiveness. The current literature indicates some value in utilizing robotic technology in specific urgent procedures, such as cholecystectomies and incarcerated hernia repairs; however, the high cost of robotic surgery was found to be a potential barrier to its widespread use in acute care surgery. This narrative literature review aims to determine the cost-effectiveness of robotic-assisted surgery (RAS) in surgical procedures that are often done in urgent settings: cholecystectomies, inguinal hernia repair, ventral hernia repair, and appendectomies.

Posterior crossbite corrections in the early mixed dentition with quad helix or rapid maxillary expander: a cost-effectiveness analysis of a randomized controlled trial.

BACKGROUND: Unilateral posterior crossbite is a common malocclusion, and early treatment is recommended to enable normal growth. There are several possibilities regarding choice of appliances used for correcting this malocclusion; however, when treatment is financed by public funds the decision needs to be based not only on the effects but also on the effect in relation to the costs. OBJECTIVES: The aim was to perform a cost-effectiveness analysis comparing quad helix (QH) and rapid maxillary expanders (RME; hyrax-type) in children in the early mixed dentition. MATERIAL AND METHODS: Seventy-two patients were randomized to treatment with either QH or RME, at two different centres. Data were collected from the patient's medical records regarding success rate, number of visits, total treatment time, emergency visits, and so forth, together with answers from patient questionnaires concerning absence from school and use of analgesics. A cost-effectiveness analysis with both an intention-to-treat (ITT) and a per-protocol approach was performed, as well as a deterministic sensitivity analysis. RESULTS: The success rate, one year after the completion of the expansion, was equal between groups according to the ITT approach. From a healthcare perspective, the mean cost difference between RME and QH was €32.05 in favour of QH (P = 0.583; NS). From a societal perspective, the mean cost difference was €32.61 in favour of QH (P = 0.742; NS). The total appliance cost alone was higher in the RME group €202.67 resp. €155.58 in the QH group (P = 0.001). The probability of RME having a higher cost was 71% from a healthcare perspective and 62.7% from a societal perspective. The total treatment time was 97 days longer in the QH group. In the deterministic sensitivity analysis, when using a higher valuation of the children's educational loss, the QH becomes €58 more costly than the RME. There was a statistically significant difference in chair time and visits between centres (P < 0.001). CONCLUSION: The difference in costs between RME and QH is not statistically significant, however, there is a slightly higher probability that RME is more expensive than QH with a mean cost of an additional €32 per patient from a healthcare perspective. Different work procedures at different centres indicate that logistics around the patient's treatment is a more important aspect than appliance used to decrease the number of visits and save chair time and thereby also costs.

Cost-effectiveness analysis of tislelizumab vs. camrelizumab for the treatment of second-line locally advanced or metastatic esophageal squamous cell carcinoma.

BACKGROUND: Esophageal carcinoma is a type of cancer that occurs in the esophagus. For patients with locally advanced or metastatic esophageal squamous cell carcinoma who have either experienced disease progression following first-line standard chemotherapy or are intolerant to it, the prognosis is typically poor. Additionally, these patients often bear a substantial economic burden during the course of their treatment. Tislelizumab is a selective PD-1 inhibitor with efficacy proven in locally advanced or metastatic esophageal squamous cell carcinoma. The study aims to evaluate the cost-effectiveness of tislelizumab versus camrelizumab as the second-line treatment in locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) patients in China. METHODS: From the perspective of China's healthcare system, the partitioned survival model with three health states was established in a 3-week cycle and a lifetime horizon. Anchored matching adjusted indirect comparison was used for survival analyses based on individual patient data from RATIONALE 302 trial and the published ESCORT study due to the lack of head-to-head clinical trials. Only direct medical costs were included. Costs and utility values were derived from local charges, the published literature, and related databases. Sensitivity analyses and a scenario analysis were also performed to verify the robustness of the model results. RESULTS: Compared with camrelizumab monotherapy, tislelizumab monotherapy incurred a lower lifetime cost ($8,346 vs. $8,851) and yielded higher quality-adjusted life-years (QALYs) (0.87 vs. 0.63), which resulted in an incremental cost-effectiveness ratio (ICER) of -$2,051/QALY. Tislelizumab monotherapy is a dominant option over camrelizumab monotherapy in China. The three primary parameters upon which this result was most sensitive were the unit cost of camrelizumab, the unit cost of tislelizumab, and the duration of reactive cutaneous capillary endothelial proliferation (RCCEP). According to the probabilistic sensitivity analysis (PSA), tislelizumab monotherapy was 100% cost-effective when the WTP was 1-3 times GDP per capita in China($11,207/QALY∼$33,621/QALY). Scenario analysis showed that the result was consistent. CONCLUSION: Tislelizumab monotherapy is a dominant option compared with camrelizumab monotherapy as the second-line treatment for locally advanced or metastatic ESCC in China.

Cost-effectiveness of drug consumption rooms in France: a modelling study.

BACKGROUND: People who inject drugs (PWID) experience many health problems which result in a heavy economic and public health burden. To tackle this issue, France opened two drug consumption rooms (DCRs) in Paris and Strasbourg in 2016. This study assessed their long-term health benefits, costs and cost-effectiveness. METHODS: We developed a model to simulate two fictive cohorts for each city (n=2,997 in Paris and n=2,971 in Strasbourg) i) PWID attending a DCR over the period 2016-2026, ii) PWID attending no DCR. The model accounted for HIV and HCV infections, skin abscesses and related infective endocarditis, drug overdoses and emergency department visits. We estimated the number of health events and associated costs over 2016-2026, the lifetime number of quality-adjusted life-years (QALYs) and costs, and the incremental cost-effectiveness ratio (ICER). RESULTS: The numbers of abscesses and associated infective endocarditis, drug overdoses, and emergency department visits decreased significantly in PWID attending DCRs (-77%, -69%, and -65%, respectively) but the impact on HIV and HCV infections was modest (-11% and -6%, respectively). This resulted in savings of €6.6 (Paris) and €5.8 (Strasbourg) millions of medical costs. The ICER of DRCs was €30,600/QALY (Paris) and €9,200/QALY (Strasbourg). In scenario analysis where drug consumption spaces are implemented inside existing harm reduction structures, these ICERs decreased to €21,400/QALY and €2,500/QALY, respectively. CONCLUSIONS: Our findings show that DCRs are highly effective and efficient to prevent harms in PWID in France, and advocate extending this intervention to other cities by adding drug consumption spaces inside existing harm reduction centers.

Reducing overdose deaths among persons with opioid use disorder in connecticut.

BACKGROUND: People in Connecticut are now more likely to die of a drug-related overdose than a traffic accident. While Connecticut has had some success in slowing the rise in overdose death rates, substantial additional progress is necessary. METHODS: We developed, verified, and calibrated a mechanistic simulation of alternative overdose prevention policy options, including scaling up naloxone (NLX) distribution in the community and medications for opioid use disorder (OUD) among people who are incarcerated (MOUD-INC) and in the community (MOUD-COM) in a simulated cohort of people with OUD in Connecticut. We estimated how maximally scaling up each option individually and in combinations would impact 5-year overdose deaths, life-years, and quality-adjusted life-years. All costs were assessed in 2021 USD, employing a health sector perspective in base-case analyses and a societal perspective in sensitivity analyses, using a 3% discount rate and 5-year and lifetime time horizons. RESULTS: Maximally scaling NLX alone reduces overdose deaths 20% in the next 5 years at a favorable incremental cost-effectiveness ratio (ICER); if injectable rather than intranasal NLX was distributed, 240 additional overdose deaths could be prevented. Maximally scaling MOUD-COM and MOUD-INC alone reduce overdose deaths by 14% and 6% respectively at favorable ICERS. Considering all permutations of scaling up policies, scaling NLX and MOUD-COM together is the cost-effective choice, reducing overdose deaths 32% at ICER $19,000/QALY. In sensitivity analyses using a societal perspective, all policy options were cost saving and overdose deaths reduced 33% over 5 years while saving society $338,000 per capita over the simulated cohort lifetime. CONCLUSIONS: Maximally scaling access to naloxone and MOUD in the community can reduce 5-year overdose deaths by 32% among people with OUD in Connecticut under realistic budget scenarios. If societal cost savings due to increased productivity and reduced crime costs are considered, one-third of overdose deaths can be reduced by maximally scaling all three policy options, while saving money.

Cost-effectiveness analysis of once-weekly semaglutide vs. once-daily liraglutide administered subcutaneously in patients with overweight and obesity: a decision analysis.

OBJECTIVE: Obesity presents an enduring and multifaceted dilemma that impacts individuals, society, economies, and healthcare systems alike. Glucagon-like peptide-1 (GLP-1) receptor agonists, including liraglutide and semaglutide, have received FDA approval for obesity treatment. This study aims to present a cost-effectiveness analysis to compare the cost and clinical outcomes of semaglutide vs. liraglutide on weight loss in people with overweight and obesity. MATERIALS AND METHODS: A cost-effectiveness analysis was conducted to compare the cost and the clinical outcomes of adding weekly 2.4 mg SC semaglutide vs. daily 3.0 mg SC liraglutide or placebo to physical activity and diet control in overweight and obese patients. A clinical outcome of achieving ≥15% weight loss was chosen. A simple decision analysis model from a third-payer perspective was applied. Drug costs were based on the retail price of the USA market. One-way sensitivity analyses were performed. RESULTS: Results showed that 2.4 mg weekly semaglutide, when added to physical activity and diet control, was the most cost-effective choice in terms of ≥15% weight loss (ICER: $ 7,056/patient/68 weeks). The model was robust against the 50% increase in the unit cost of semaglutide and the 50% decrease in the unit cost of liraglutide, as well as the changes in probabilities by the corresponding 95% confidence intervals across the model. CONCLUSIONS: This cost-effectiveness analysis suggests that employing once-weekly 2.4 mg semaglutide emerges as a remarkably cost-effective option when contrasted with once-daily 3.0 mg liraglutide in patients with overweight and obesity when added to physical activity and diet control.

[Economic and clinical aspects of postoperative bandages selection: in search of the best solution]. / Ekonomicheskie i klinicheskie aspekty vybora posleoperatsionnykh povyazok: v poiskakh optimal'nogo resheniya.

OBJECTIVE: Investigation of the clinical and economic advisability of using self-adhesive wound bandages of plaster type (on the example of Cosmopor E steril) compared to gauze bandages in the conditions of medical organization. METHODS: Study design - a retrospective analysis of literature data. Methods of pharmacoeconomic analysis - cost minimization analysis, «impact on budget¼ analysis. The Unified Information System in Procurement was the information source of the self-adhesive bandages cost. The charges of gauze bandages production were calculated on the basis of data provided by structural subdivisions of SamSMU Clinics. RESULTS: It was determined that the use of self-adhesive bandages of plaster type is economically feasible as a result of the analysis of cost minimization and impact on the budget. Saving during 1 year can be from 259 466 to 532 603 rubles (in total for three departments - 1.1 million rubles). Sensitivity analysis showed the stability of the obtained results to the variation of entry conditions (costs for gauze bandages and bandages of plaster type) in a wide range of values. CONCLUSION: The data obtained from the study showed that the use of bandages of plaster type for different types of surgical treatment is more justified in terms of cost saving.

Effect of fluoridated water on invasive NHS dental treatments for adults: the LOTUS retrospective cohort study and economic evaluation.

Background: Most water fluoridation studies were conducted on children before the widespread introduction of fluoride toothpastes. There is a lack of evidence that can be applied to contemporary populations, particularly adolescents and adults. Objective: To pragmatically assess the clinical and cost effectiveness of water fluoridation for preventing dental treatment and improving oral health in a contemporary population of adults, using a natural experiment design. Design: Retrospective cohort study using routinely collected National Health Service dental claims (FP17) data. Setting: National Health Service primary dental care: general dental practices, prisons, community dental services, domiciliary settings, urgent/out-of-hours and specialised referral-only services. Participants: Dental patients aged 12 years and over living in England (n = 6,370,280). Intervention and comparison: Individuals exposed to drinking water with a fluoride concentration ≥ 0.7 mg F/l between 2010 and 2020 were matched to non-exposed individuals on key characteristics using propensity scores. Outcome measures: Primary: number of National Health Service invasive dental treatments (restorations/'fillings' and extractions) received per person between 2010 and 2020. Secondary: decayed, missing and filled teeth, missing teeth, inequalities, cost effectiveness and return on investment. Data sources: National Health Service Business Services Authority dental claims data. Water quality monitoring data. Primary outcome: Predicted mean number of invasive dental treatments was 3% lower in the optimally fluoridated group than in the sub/non-optimally fluoridated group (incidence rate ratio 0.969, 95% CI 0.967 to 0.971), a difference of -0.173 invasive dental treatments (95% CI -0.185 to -0.161). This magnitude of effect is smaller than what most stakeholders we engaged with (n = 50/54) considered meaningful. Secondary outcomes: Mean decayed, missing and filled teeth were 2% lower in the optimally fluoridated group, with a difference of -0.212 decayed, missing and filled teeth (95% CI -0.229 to -0.194). There was no statistically significant difference in the mean number of missing teeth per person (0.006, 95% CI -0.008 to 0.021). There was no compelling evidence that water fluoridation reduced social inequalities in treatments received or missing teeth; however, decayed, missing and filled teeth data did not demonstrate a typical inequalities gradient. Optimal water fluoridation in England in 2010-20 was estimated to cost £10.30 per person (excluding original setup costs). Mean National Health Service treatment costs for fluoridated patients 2010-20 were 5.5% lower per person, by £22.26 (95% CI -£23.09 to -£21.43), and patients paid £7.64 less in National Health Service dental charges per person (2020 prices). Limitations: Pragmatic, observational study with potential for non-differential errors of misclassification in fluoridation assignment and outcome measurement and residual and/or unmeasured confounding. Decayed, missing and filled teeth data have not been validated. Water fluoridation cost estimates are based on existing programmes between 2010 and 2020, and therefore do not include the potentially significant capital investment required for new programmes. Conclusions: Receipt of optimal water fluoridation between 2010 and 2020 resulted in very small health effects, which may not be meaningful for individuals, and we could find no evidence of a reduction in social inequalities. Existing water fluoridation programmes in England produced a positive return on investment between 2010 and 2020 due to slightly lower National Health Service treatment costs. These relatively small savings should be evaluated against the projected costs and lifespan of any proposed capital investment in water fluoridation, including new programmes. Future work: National Health Service dental data are a valuable resource for research. Further validation and measures to improve quality and completeness are warranted. Trial registrations: This trial is registered as ISRCTN96479279, CAG: 20/CAG/0072, IRAS: 20/NE/0144. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: NIHR128533) and is published in full in Public Health Research; Vol. 12, No. 5. See the NIHR Funding and Awards website for further award information.

Fluoride is a natural mineral that prevents tooth decay. It is added to some drinking water and toothpastes to improve dental health. Water with fluoride added is known as 'optimally fluoridated'. Most research on water fluoridation was carried out before fluoride was added to toothpastes in the 1970s and only included children. We wanted to know if water fluoridation still produced large reductions in tooth decay, now that decay levels are much lower because of fluoride in toothpaste. We also wanted to look at its effect on adults and teenagers. Dental patients we spoke to told us they worried about needing treatment with the 'drill', or 'injection', losing their teeth and paying for their dental care. To see if water fluoridation helped with these concerns, we compared the National Health Service dental records of 6.4 million adults and teenagers who received optimally fluoridated or non-optimally fluoridated water in England between 2010 and 2020. We found water fluoridation made a very small difference to each person. Between 2010 and 2020, the number of NHS fillings and extractions was 3% lower per person for those who received optimally fluoridated water. We found no difference in the number of teeth lost per person and no strong sign that fluoridation reduced differences in dental health between rich and poor areas. Between 2010 and 2020, the cost of optimal water fluoridation was £10.30 per person (not including setup costs). National Health Service dental patients who received optimally fluoridated water cost the National Health Service £22.26 (5.5%) less and paid £7.64 (2%) less per person in National Health Service dental charges over the 10 years. The benefits we found are much smaller than in the past, when toothpastes did not contain fluoride. The cost to set up a new water fluoridation programme can be high. Communities may need to consider if these smaller benefits would still outweigh the costs.

Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain.

INTRODUCTION: Gestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes. METHODS AND ANALYSIS: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed. ETHICS AND DISSEMINATION: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project. TRIAL REGISTRATION NUMBER: ACTRN12620001240932.

Plasma-derived extracellular matrix for xenofree and cost-effective organoid modeling for hepatocellular carcinoma.

BACKGROUND: Hepatocellular carcinoma (HCC) causes significant cancer mortality worldwide. Cancer organoids can serve as useful disease models by high costs, complexity, and contamination risks from animal-derived products and extracellular matrix (ECM) that limit its applications. On the other hand, synthetic ECM alternatives also have limitations in mimicking native biocomplexity. This study explores the development of a physiologically relevant HCC organoid model using plasma-derived extracellular matrix as a scaffold and nutritive biomatrix with different cellularity components to better mimic the heterogenous HCC microenvironment. Plasma-rich platelet is recognized for its elevated levels of growth factors, which can promote cell proliferation. By employing it as a biomatrix for organoid culture there is a potential to enhance the quality and functionality of organoid models for diverse applications in biomedical research and regenerative medicine and to better replicate the heterogeneous microenvironment of HCC. METHOD: To generate the liver cancer organoids, HUH-7 hepatoma cells were cultured alone (homogenous model) or with human bone marrow-derived mesenchymal stromal cells and human umbilical vein endothelial cells (heterogeneous model) in plasma-rich platelet extracellular matrix (ECM). The organoids were grown for 14 days and analyzed for cancer properties including cell viability, invasion, stemness, and drug resistance. RESULTS: HCC organoids were developed comprising HUH-7 hepatoma cells with or without human mesenchymal stromal and endothelial cells in plasma ECM scaffolds. Both homogeneous (HUH-7 only) and heterogeneous (mixed cellularity) organoids displayed viability, cancer hallmarks, and chemoresistance. The heterogeneous organoids showed enhanced invasion potential, cancer stem cell populations, and late-stage HCC genetic signatures versus homogeneous counterparts. CONCLUSION: The engineered HCC organoids system offers a clinically relevant and cost-effective model to study liver cancer pathogenesis, stromal interactions, and drug resistance. The plasma ECM-based culture technique could enable standardized and reproducible HCC modeling. It could also provide a promising option for organoid culture and scaling up.

High-precision stereotactic irradiation for focal drug-resistant epilepsy versus standard treatment: a randomized waitlist-controlled trial (the PRECISION trial).

INTRODUCTION: The standard treatment for patients with focal drug-resistant epilepsy (DRE) who are not eligible for open brain surgery is the continuation of anti-seizure medication (ASM) and neuromodulation. This treatment does not cure epilepsy but only decreases severity. The PRECISION trial offers a non-invasive, possibly curative intervention for these patients, which consist of a single stereotactic radiotherapy (SRT) treatment. Previous studies have shown promising results of SRT in this patient population. Nevertheless, this intervention is not yet available and reimbursed in the Netherlands. We hypothesize that: SRT is a superior treatment option compared to palliative standard of care, for patients with focal DRE, not eligible for open surgery, resulting in a higher reduction of seizure frequency (with 50% of the patients reaching a 75% seizure frequency reduction at 2 years follow-up). METHODS: In this waitlist-controlled phase 3 clinical trial, participants are randomly assigned in a 1:1 ratio to either receive SRT as the intervention, while the standard treatments consist of ASM continuation and neuromodulation. After 2-year follow-up, patients randomized for the standard treatment (waitlist-control group) are offered SRT. Patients aged ≥ 18 years with focal DRE and a pretreatment defined epileptogenic zone (EZ) not eligible for open surgery will be included. The intervention is a LINAC-based single fraction (24 Gy) SRT treatment. The target volume is defined as the epileptogenic zone (EZ) on all (non) invasive examinations. The seizure frequency will be monitored on a daily basis using an electronic diary and an automatic seizure detection system during the night. Potential side effects are evaluated using advanced MRI, cognitive evaluation, Common Toxicity Criteria, and patient-reported outcome questionnaires. In addition, the cost-effectiveness of the SRT treatment will be evaluated. DISCUSSION: This is the first randomized trial comparing SRT with standard of care in patients with DRE, non-eligible for open surgery. The primary objective is to determine whether SRT significantly reduces the seizure frequency 2 years after treatment. The results of this trial can influence the current clinical practice and medical cost reimbursement in the Netherlands for patients with focal DRE who are not eligible for open surgery, providing a non-invasive curative treatment option. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05182437. Registered on September 27, 2021.