[Guidelines for economic evaluation of post-marketing Chinese patent medicine].

With the premise of drug safety and effectiveness, pharmacoeconomic evaluation can provide optimal solutions for diversified decision-making application scenarios from different research perspectives while maximizing the rational utilization of existing healthcare resources. Chinese patent medicine is an essential component of pharmaceutical utilization in China and a significant part of healthcare expenditure in China. However, the economic evaluation of post-marketing Chinese patent medicine is lacking. These evaluations often lack standardization, exhibit varying quality, and are unable to effectively support healthcare decisions, indicating a need for improvement in overall quality. Given this situation, this project has gathered leading experts from China and has strictly adhered to the requirements of the group standards set by the China Association of Traditional Chinese Medicine in developing Guidelines for economic evaluation of post-marketing Chinese patent medicine, aiming to provide methodological guidance for the post-market pharmacoeconomic evaluation of Chinese patent medicine, enhancing the standardization of pharmacoeconomic evaluations of Chinese patent medicine and the scientific validity of research results, and thereby elevating the overall quality of pharmacoeconomic evaluations for post-marketing Chinese patent medicine. The guidelines adhere to the framework provided by relevant laws and regulations in China and technical guidance documents. It is based on guidance from traditional Chinese medicine(TCM) theories, focusing on the unique characteristics of TCM. It covers various aspects of pharmacoeconomic evaluation, including fundamental principles, research topic selection, research question definition, study design type selection, cost identification and measurement, health outcomes, and evaluation methods. The guidelines offer methodological recommendations and decision guidance to address common issues and challenges in the pharmacoeconomic evaluation of post-marketing Chinese patent medicine.

Clinical effectiveness, cost-effectiveness and process evaluation of group schema therapy for eating disorders: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Eating disorders (EDs), such as (atypical) Anorexia (AN) and Bulimia Nervosa (BN), are difficult to treat, causing socioeconomic impediments. Although enhanced cognitive behavioral therapy (CBT-E) is widely considered clinically effective, it may not be the most beneficial treatment for (atypical) AN and BN patients who do not show a rapid response after the first 4 weeks (8 sessions) of a CBT-E treatment. Alternatively, group schema therapy (GST) may be a valuable treatment for this ED population. Even though GST for EDs has yielded promising preliminary findings, the current body of evidence requires expansion. On top of that, data on cost-effectiveness is lacking. In light of these gaps, we aim to describe a protocol to examine whether GST is more (1) clinically effective and (2) cost-effective than CBT-E for (atypical) AN and BN patients, who do not show a rapid response after the first 4 weeks of treatment. Additionally, we will conduct (3) process evaluations for both treatments. METHODS: Using a multicenter RCT design, 232 Dutch (atypical) AN and BN patients with a CBT-E referral will be recruited from five treatment centers. Clinical effectiveness and cost-effectiveness will be measured before treatment, directly after treatment, at 6 and at 12 months follow-up. In order to rate process evaluation, patient experiences and the degree to which treatments are implemented according to protocol will be measured. In order to assess the quality of life and the achievement of personalized goals, interviews will be conducted at the end of treatment. Data will be analyzed, using a regression-based approach to mixed modelling, multivariate sensitivity analyses and coding trees for qualitative data. We hypothesize GST to be superior to CBT-E in terms of clinical effectiveness and cost-effectiveness for patients who do not show a rapid response to the first 4 weeks of a CBT-E treatment. DISCUSSION: To our knowledge, this is the first study protocol describing a multicenter RCT to explore the three aforementioned objectives. Related risks in performing the study protocol have been outlined. The expected findings may serve as a guide for healthcare stakeholders to optimize ED care trajectories. TRIAL REGISTRATION: clinicaltrials.gov (NCT05812950).

Reducing the burden of travel and environmental impact through decentralization of cancer care.

Life expectancy, quality of life and satisfaction of oncologic patients highly depend on access to adequate specialized services, that consider their conditions in a holistic way. The present study aims to evaluate the introduction of oncology services in an outpatient setting in a mountain village in Northern Italy. The initiative is evaluated using the three pillars of sustainability (social, economic and environmental) as dimensions that are often overlooked by healthcare policy makers. Using micro data on 18,625 interventions, we estimate the number of kilometers saved by patients (reduction of "travel burden" as indicator of social sustainability), the additional travel costs for the NHS (indicator of economic sustainability) and the implied reduction of CO2 emissions (indicator of environmental sustainability). Over the period July 2016-2021, the decentralized health center delivered 2,292 interventions saving 218,566 km for a corresponding value of €131,140. The additional costs for the NHS was €26,152. The reduction of CO2 emissions was 32.37 Tons (€5,989). Overall, the socio-economic benefit of reducing travel of care for the patients residing in this remote valley was €110,976. This study adds original understanding of the benefits of decentralizing oncologic care and shows its operational feasibility conditions. Given the modest number of similar projects, it provides evidence to policy makers and, especially, managers who are faced with the challenge to implement the decentralization of specialized services.

Bacitracin agar vs. oleandomycin disk supplemented chocolate agar for the recovery of Haemophilus influenzae in diagnostic samples: A prospective comparison.

Haemophilus influenzae is an important pathogen able to cause various forms of respiratory and invasive disease. To provide high sensitivity for detection, culture media must inhibit growth of residential flora from the respiratory tract. This study aimed to identify and compare the diagnostic and economic advantages of using bacitracin containing selective agar (SEL) or oleandomycin disk supplemented chocolate agar (CHOC). Growth and semi-quantitative abundance of H. influenzae and growth suppression of residential flora was prospectively assessed in a 28-week period. H. influenzae was identified in 164 (5 %) of all included samples: CHOC and SEL, CHOC only, and SEL only were positive in 95, 24, and 45 cases. Diagnostic superiority of SEL was primarily attributable to the results of throat swabs. However, on average, € 200 had to be spent for the detection of each additional isolate that was recovered only because of additional incubation on SEL.

Technoeconomic and carbon footprint analysis of simulated industrial scale biodiesel production process from mixed macroalgal and non-edible seed oil using sulphonated zinc doped recyclable biochar catalyst.

The present research explored the sustainable production of biodiesel from mixed oils of marine macroalgae and non-edible seeds using a sulphonated Zinc doped recyclable biochar catalyst derived from coconut husk. The maximum biodiesel conversion of 94.8 % was yielded with optimized conditions of 10:1 methanol to oil molar ratio, 4.8 % biochar catalyst concentration, 54.5 ℃ temperature and 87.4 min reaction time. A techno-economic assessment provided a favourable return on investment (ROI) of 21.59 % and 4.63 years of reimbursement period, with a calculated minimum selling price of 0.81 $/kg of produced biodiesel. The carbon footprint analysis results estimated an annual emission of 752.07 t CO2 which corresponds to 0.088 kg CO2 emission per kg of biodiesel produced from the simulated process. The study on economic viability and environmental consciousness of biodiesel production not only paves the way for a greener and sustainable future while also contributing to low carbon footprint.

Overview and quality assessment of health economic evaluations for homeopathic therapy: an updated systematic review.

INTRODUCTION: Likewise other medical interventions, economic evaluations of homeopathy contribute to the evidence base of therapeutic concepts and are needed for socioeconomic decision-making. A 2013 review was updated and extended to gain a current overview. METHODS: A systematic literature search of the terms 'cost' and 'homeopathy' from January 2012 to July 2022 was performed in electronic databases. Two independent reviewers checked records, extracted data, and assessed study quality using the Consensus on Health Economic Criteria (CHEC) list. RESULTS: Six studies were added to 15 from the previous review. Synthesizing both health outcomes and costs showed homeopathic treatment being at least equally effective for less or similar costs than control in 14 of 21 studies. Three found improved outcomes at higher costs, two of which showed cost-effectiveness for homeopathy by incremental analysis. One found similar results and three similar outcomes at higher costs for homeopathy. CHEC values ranged between two and 16, with studies before 2009 having lower values (Mean ± SD: 6.7 ± 3.4) than newer studies (9.4 ± 4.3). CONCLUSION: Although results of the CHEC assessment show a positive chronological development, the favorable cost-effectiveness of homeopathic treatments seen in a small number of high-quality studies is undercut by too many examples of methodologically poor research.

To help make decisions about homeopathy in healthcare, it is important, as with other medical treatments, to look at whether this treatment is effective in relation to its costs; in other words, to see if it is cost-effective. The aim of the current work was to update the picture of scientific studies available on this topic until 2012. To this purpose, two different researchers screened electronic literature databases for studies between January 2012 and July 2022 which assessed both the costs and the effects of a homeopathic treatment. They did this according to strict rules to make sure that no important study was missed. They reviewed the search results, gathered information from the studies, and assessed the quality of the studies using a set of criteria. They detected six additional new studies to the 15 already known from the previous work. Overall, they found that in 14 out of 21 studies, homeopathic treatment was at least equally effective for less or similar costs. For the remaining seven studies, costs were equal or higher for homeopathy. Of these seven, two were shown to be advantageous for homeopathy: indeed, specific economic analyses demonstrated that the benefit of the homeopathic treatment compensated for the higher costs. For the remaining five studies, the higher or equal costs of homeopathic treatment were not compensated by a better effect. The quality of the studies varied, with older studies generally being of lower quality compared to newer ones. The authors concluded that although the quality of research on homeopathy's cost-effectiveness has improved over time, and some high-quality studies show that it can be a cost-effective option, there are still many poorly conducted studies which make it difficult to offer a definitive statement. In other words, while there is some evidence that homeopathy can be effective in relation to its costs, there are still many studies that are not very reliable, which means that interested parties need to be cautious about drawing conclusions.

Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial.

BACKGROUND: Urinary incontinence (UI) is prevalent in more than half of residents of nursing and residential care homes and can have a detrimental impact on dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. We examined the costs and consequences of delivering TTNS to care home residents in comparison to sham (inactive) electrical stimulation. METHODS: A cost consequence analysis approach was used to assemble and present the resource use and outcome data for the ELECTRIC trial which randomised 406 residents with UI from 37 care homes in the United Kingdom to receive 12 sessions of 30 min of either TTNS or sham (inactive) TTNS. TTNS was administered by care home staff over 6 weeks. Health state utility was measured using DEMQOL-U and DEMQOL-PROXY-U at baseline, 6 weeks and 18 weeks follow-up. Staff completed a resource use questionnaire at baseline, 6 weeks and 18 weeks follow-up, which also assessed use of absorbent pads. RESULTS: HRQoL did not change significantly in either randomised group. Delivery of TTNS was estimated to cost £81.20 per participant, plus training and support costs of £121.03 per staff member. 85% of participants needed toilet assistance as routine, on average requiring one or two staff members to be involved 4 or 5 times in each 24 h. Daily use of mobility aids and other assistive devices to use the toilet were reported. The value of staff time to assist residents to use the toilet (assuming an average of 5 min per resident per visit) was estimated as £19.17 (SD 13.22) for TTNS and £17.30 (SD 13.33) for sham (per resident in a 24-hour period). CONCLUSIONS: Use of TTNS to treat UI in care home residents did not lead to changes in resource use, particularly any reduction in the use of absorbent pads and no cost benefits for TTNS were shown. Managing continence in care homes is labour intensive, requiring both high levels of staff time and use of equipment aids. TRIAL REGISTRATION: ISRCTN98415244, registered 25/04/2018. NCT03248362 (Clinical trial.gov number), registered 14/08//2017.

Cost-effectiveness of alternative first- and second-line treatments for benign prostatic hyperplasia in Singapore.

BACKGROUND: Minimally invasive surgical therapies, such as water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL), are typically second-line options for patients in whom medical management (MM) failed but who are unwilling or unsuitable to undergo invasive transurethral resection of the prostate (TURP). However, the incremental cost-effectiveness of WVTT or PUL as first- or second-line therapy is unknown. We evaluated the incremental cost-effectiveness of alternative first- and second-line treatments for patients with moderate-to-severe benign prostatic hyperplasia (BPH) in Singapore to help policymakers make subsidy decisions based on value for money. METHODS: We considered six stepped-up treatment strategies, beginning with MM, WVTT, PUL or TURP. In each strategy, patients requiring retreatment advance to a more invasive treatment until TURP, which may be undergone twice. A Markov cohort model was used to simulate transitions between BPH severity states and retreatment, accruing costs and quality-adjusted life-years (QALYs) over a lifetime horizon. RESULTS: In moderate patients, strategies beginning with MM had similar cost and effectiveness, and first-line WVTT was incrementally cost-effective to first-line MM (33,307 SGD/QALY). First-line TURP was not incrementally cost-effective to first-line WVTT (159,361 SGD/QALY). For severe patients, WVTT was incrementally cost-effective to MM as a first-line treatment (30,133 SGD/QALY) and to TURP as a second-line treatment following MM (6877 SGD/QALY). TURP was incrementally cost-effective to WVTT as a first-line treatment (48,209 SGD/QALY) in severe patients only. All pathways involving PUL were dominated (higher costs and lower QALYs). CONCLUSION: Based on the common willingness-to-pay threshold of SGD 50,000/QALY, this study demonstrates the cost-effectiveness of WVTT over MM as first-line treatment for patients with moderate or severe BPH, suggesting it represents good value for money and should be considered for subsidy. PUL is not cost-effective as a first- nor second-line treatment. For patients with severe BPH, TURP as first-line is also cost-effective.

Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate, common among older men. Its symptoms include difficulties with starting and completing urination, incontinence, frequent and urgent need to urinate. Minimally invasive procedures, such as water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL), are typically offered as second-line options to patients for whom medication has failed but who are unwilling or unsuitable to undergo invasive surgery (transurethral resection of the prostate, TURP). However, whether offering these procedures as first-line options represents good value for money (i.e. cost-effectiveness) is an open question. To address this question and inform subsidy decisions in Singapore, we investigated six stepped-up treatment strategies which differ in first- and second-line treatments. For each strategy, we simulated healthcare costs and quality of life for a cohort of moderate and severe BPH patients over their lifetime, considering the possibility of treatment-related adverse effects and multiple rounds of retreatment. The incremental cost of a unit improvement in quality of life for a strategy relative to the next most expensive one was compared against a willingness-to-pay threshold to determine cost-effectiveness. We found that WVTT was cost-effective relative to medication as a first-line treatment for patients with moderate or severe BPH, suggesting it represents good value for money and should be considered for subsidy. PUL was not cost-effective as first- nor second-line treatment. TURP is cost-effective as first-line for severe BPH patients only.

Economic evaluation of acupuncture as an adjunctive treatment with usual care for mild-to-moderate knee osteoarthritis: A Markov model-based analysis.

Background: Collaborative care (CC), in which acupuncture is combined with usual care (UC), improves clinical outcomes and increases costs in knee osteoarthritis (KOA). We evaluated the economic feasibility of CC for Korean female patients with mild-to-moderate KOA by using a cost-effectiveness approach. Methods: Two alternatives for KOA (1. UC as a comparator; and 2. CC as an intervention) were defined based on clinical guidelines, official Korean statistics, and expert validation. Each alternative was simulated in a Markov model every 6 months for 10 years. Estimates of costs, utilities, and transition probabilities were obtained from official statistics and previous studies. The effectiveness of CC was synthesized from randomized controlled trials. A base-case analysis of a limited societal perspective, univariate sensitivity analysis, and probability sensitivity analysis were performed. An annual discount rate of 4.5% and threshold of 20,000 United States dollar per Quality-adjusted life year (USD/QALY) were applied. Results: Every incremental cost-effectiveness ratio (ICER) of CC calculated from the analyses was sub-threshold. In the base-case analysis, with a limited societal perspective, the ICER was 11,085 USD/QALY. The ICERs from the univariate sensitivity analyses were -2,577-16,748 USD/QALY. The average ICER in the probability sensitivity analysis was 12,412 USD/QALY. When the threshold surpassed 8,000 USD/QALY, the cost-effectiveness of CC exceeded 50%. The probability was 70.27% when the threshold was 20,000 USD/QALY. Conclusions: CC for Korean female patients with mild-to-moderate KOA was generally cost-effective. Considering the limitations of the evidence, we propose a re-evaluation using further clinical studies in the future.

Study protocol of an economic evaluation embedded in the Midwives and Obstetricians Helping Mothers to Quit Smoking (MOHMQuit) trial.

BACKGROUND: Tobacco smoking during pregnancy is the most important preventable risk factor for pregnancy complications and adverse birth outcomes and can have lifelong consequences for infants. Smoking during pregnancy is associated with higher healthcare costs related to birth complications and during childhood. Psychosocial interventions to support pregnant women to quit are effective, yet provision of smoking cessation support has been inconsistent. The Midwives and Obstetricians Helping Mothers to Quit Smoking (MOHMQuit) intervention provides systems change, and leadership and clinician elements, to support clinicians to help women stop smoking in pregnancy. There have been few long-term analyses conducted of the cost-effectiveness of smoking cessation interventions for pregnant women that target healthcare providers. This protocol describes the economic evaluation of the MOHMQuit trial, a pragmatic stepped-wedge cluster-randomised controlled implementation trial in nine public maternity services in New South Wales (NSW), Australia, to ascertain whether MOHMQuit is cost-effective in supporting clinicians to help women quit smoking in pregnancy compared to usual care. METHODS: Two primary analyses will be carried out comparing MOHMQuit with usual care from an Australian health care system perspective: i) a within-trial cost-effectiveness analysis with results presented as the incremental cost per additional quitter; and ii) a lifetime cost-utility analysis using a published probabilistic decision analytic Markov model with results presented as incremental cost per quality-adjusted life-year (QALY) gained for mother and child. Patient-level data on resource use and outcomes will be used in the within-trial analysis and extrapolated and supplemented with national population statistics and published data from the literature for the lifetime analysis. DISCUSSION: There is increasing demand for information on the cost-effectiveness of implementing healthcare interventions to provide policy makers with critical information for the best value for money within finite budgets. Economic evaluation of the MOHMQuit trial will provide essential, policy-relevant information for decision makers on the value of evidence-based implementation of support for healthcare providers delivering services for pregnant women. TRIAL REGISTRATIONS: ACTRN12622000167763, registered 2 February 2022.

Economic Evaluation of Glucosamine in Knee Osteoarthritis Treatments in Vietnam.

Osteoarthritis (OA) is the degeneration of cartilage in joints that results in bones rubbing against each other; it causes uncomfortable symptoms such as pain, swelling, and stiffness and can lead to disability. It usually occurs in the elderly and causes a large medical burden. The aim of this study is to evaluate the cost-effectiveness between the standard treatment for osteoarthritis and standard treatment with added crystalline glucosamine sulfate at various stages. Markov analysis modeling was applied to evaluate the effect of both adding glucosamine compared to standard treatment from a societal perspective during whole patients' lifetimes. Data input was collected from reviews in previous studies. The outcome was measured in quality-adjusted life years (QALYs), and the Incremental Cost-Effectiveness Ratio (ICER) from a societal perspective was applied with 3% and discounted for all costs and outcomes. One-way analysis via the Tornado diagram was performed to investigate the change in factors in the model. In general, adding glucosamine into the standard treatment proved to be more cost-effective compared to the standard treatment. Particularly, the early-stage addition of glucosamine in the treatment was cost-effective compared to the post-stage addition of glucosamine. The addition of supplementing crystalline glucosamine sulfate to the whole regimen at any stage was cost-effective at the willingness-to-pay (WTP) threshold.

Cost-effectiveness of pemigatinib as a second-line treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 fusions in Taiwan: from the evidence of the phase II trial and the perspective of Taiwan's National Health Insurance Administration.

BACKGROUND: In December 2022, the Taiwan National Health Insurance Administration (NHIA) announced the reimbursement of three dosages of pemigatinib 4.5 mg, 9 mg, and 13.5 mg for treating advanced intrahepatic cholangiocarcinoma (ICC) with fibroblast growth factor receptor 2 (FGFR2) fusions/rearrangements and set the reimbursement price for pemigatinib 4.5 mg at NT$6600. This study aims to analyze the cost-effectiveness of pemigatinib 13.5 mg as a second-line treatment compared to mFOLFOX and 5-FU chemotherapy for advanced ICC patients with FGFR2 fusions/rearrangements from the perspective of Taiwan's NHIA. METHODS: This study used a 3-state partitioned survival model to analyze the 5 year cost-effectiveness of pemigatinib as a second-line treatment for advanced ICC patients in whom first-line gemcitabine-based chemotherapy failed and to compare the results with those for the mFOLFOX and 5-FU chemotherapy regimens. Overall survival and progression-free survival were estimated from the FIGHT-202 trial (pemigatinib), ABC-06 trial (mFOLFOX), and NIFTY trial (5-FU). The price of pemigatinib 13.5 mg was set at the potentially highest listing price (NT$17,820). Other parameters of utility, disutility, and costs related to advanced ICC were obtained from the published literature. The willingness-to-pay threshold was three times the forecasted gross domestic product per capita in 2022 (NT$2,928,570). A 3% discount rate was applied to quality-adjusted life-years (QALYs) and costs. Several scenario analyses were performed, including a gradual price reduction for pemigatinib. Deterministic sensitivity analysis, probabilistic sensitivity analysis (PSA), and value of information were performed to assess uncertainty. RESULTS: Pemigatinib was not cost-effective compared to mFOLFOX or 5-FU in the base-case analysis. When the price of pemigatinib was reduced by 50% or more, pemigatinib gained a positive net monetary benefit (mFOLFOX: NT$55,374; 5-FU: NT$92,437) and a 72% (mFOLFOX) and 77.1% (5-FU) probability of being cost-effective. Most of the uncertainty came from the medication cost of pemigatinib, health state utility, and the overall survival associated with pemigatinib. CONCLUSIONS: According to the NCCN guidelines, the daily use of pemigatinib 13.5 mg at the hypothesized NHIA price of NT$17,820/13.5 mg was not cost-effective compared to mFOLFOX or 5-FU. The price reduction scenario suggested a 50% price reduction, NT$8910 per 13.5 mg, for advanced ICC patients with FGFR2 fusions/rearrangements.

This study performed a cost-effectiveness analysis on the use of targeted therapy pemigatinib 13.5 mg daily in second-line treatment for Taiwanese patients with intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions/rearrangements. This regimen was approved by the U.S. Food and Drug Administration in 2020 and recommended by the National Comprehensive Cancer Network (NCCN). Taiwan's National Health Insurance Administration (NHIA) has announced the reimbursement of three pemigatinib dosages of 4.5 mg, 9 mg, and 13.5 mg to be listed in the NHI coverage in 2022. However, as of the middle of April 2023, only the listing price for pemigatinib 4.5 mg has been determined, while pricing for the other two dosages remains pending. Based on a hypothesized NHIA price of NT$17,820/13.5 mg, this study evaluated the cost-effectiveness of pemigatinib 13.5 mg as a second-line treatment for advanced ICC with FGFR2 fusions/rearrangements compared to mFOLFOX (a regimen recommended by NCCN) and 5-FU (a regimen fully covered by Taiwan NHIA) and recommended a listing price for NHIA as reference. Our study showed that the hypothesized price of NT$17,820/13.5 mg was not cost-effective compared to mFOLFOX or 5-FU. The price reduction scenario suggested a 50% reduction (NT$8910) in the hypothesized NHIA price for advanced ICC patients with FGFR2 fusions/rearrangements.

Effectiveness of group arts therapies (art therapy, dance movement therapy and music therapy) compared to group counselling for diagnostically heterogeneous psychiatric community patients: study protocol for a randomised controlled trial in mental health services (the ERA study).

BACKGROUND: Arts therapies are widely but inconsistently provided in community mental health. Whilst they are appealing to patients, evidence for their effectiveness is mixed. Trials to date have been limited to one art-form or diagnosis. Patients may hold strong preferences for or against an art-form whilst group therapies rely on heterogeneity to provide a range of learning experiences. This study will test whether manualised group arts therapies (art therapy, dance movement therapy and music therapy) are effective in reducing psychological distress for diagnostically heterogeneous patients in community mental health compared to active group counselling control. METHODS: A pragmatic multi-centre 2-arm randomised controlled superiority trial with health economic evaluation and nested process evaluation. Adults aged ≥ 18, living in the community with a primary diagnosis of psychosis, mood, or anxiety disorder will be invited to participate and provide written informed consent. Participants are eligible if they score ≥ 1.65 on the Global Severity Index of the Brief Symptom Inventory. Those eligible will view videos of arts therapies and be asked for their preference. Participants are randomised to either their preferred type of group arts therapy or counselling. Groups will run twice per week in a community venue for 20 weeks. Our primary outcome is symptom distress at the end of intervention. Secondary outcomes include observer-rated symptoms, social situation and quality of life. Data will be collected at baseline, post-intervention and 6 and 12 months post-intervention. Outcome assessors and trial statisticians will be blinded. Analysis will be intention-to-treat. Economic evaluation will assess the cost-effectiveness of group arts therapies. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of group process measures and qualitative interviews with participants and therapists. DISCUSSION: This will be the first trial to account for patient preferences and diagnostic heterogeneity in group arts therapies. As with all group therapies, there are a number of logistical challenges to which we have had to further adapt due to the COVID-19 pandemic. Overall, the study will provide evidence as to whether there is an additive benefit or not to the use of the arts in group therapy in community mental health care. TRIAL REGISTRATION: ISRCTN, ISRCTN88805048 . Registered on 12 September 2018.

Methodological choices for an economic evaluation of a combined psychosocial and nutrition treatment intervention for children with severe acute malnutrition: The FUSAM trial in Nepal.

As a public health burden, severe acute malnutrition (SAM) among children has been increasingly studied to determine the optimal combination of treatment approaches. Among the new approaches is the addition of early childhood development sessions to standard nutrition-based treatment for SAM which can enhance both nutrition and development outcomes among young children. However, few studies demonstrate the relationship between the costs of such combined programs and the benefits accrued to the children and their caregivers. This article describes our experience of designing and conducting an economic evaluation alongside a cluster randomized controlled trial assessing a combined nutrition and psychosocial intervention for the treatment of SAM in children aged 6-24 months in Nepal. We present key lessons learned regarding methodological choices, the challenges of field data collection, as well as study adjustment when data analysis did not unfold as anticipated. With the view to transparency, this manuscript provides some clarifications on the evaluation processes for funders and policy makers on what economic evaluations entail and what information they convey for the purpose of supporting policy decision-making around limited resource allocation.

Hypoparathyroidism-related health care utilization and expenditure during the first postoperative year after total thyroidectomy for cancer: a comprehensive national cohort study.

Objectives: Hypoparathyroidism is the most common complication of total thyroidectomy for cancer, and requires calcium and/or vitamin D supplementation for an unpredictable period of time. The additional cost associated with this complication has not hitherto been assessed. The aim of this study was to assess the economic burden of postoperative hypoparathyroidism after total thyroidectomy for cancer in France. Methods: Based on the French national cancer cohort, which extracts data from the French National Health Data System (SNDS), all adult patients who underwent a total thyroidectomy for cancer in France between 2011 and 2015 were identified, and their healthcare resource use during the first postoperative year was compared according to whether they were treated postoperatively with calcium and/or vitamin D or not. Univariate and multivariate cost analyses were performed with the non-parametric Wilcoxon test and generalized linear model (gamma distribution and log link), respectively. Results: Among the 31,175 patients analyzed (75% female, median age: 52y), 13,247 (42%) started calcium and/or vitamin D supplementation within the first postoperative month, and 2,855 patients (9.1%) were still treated at 1 year. Over the first postoperative year, mean overall and specific health expenditures were significantly higher for treated patients than for untreated patients: €7,233 vs €6,934 per patient (p<0.0001) and €478.6 vs €332.7 per patient (p<0.0001), respectively. After adjusting for age, gender, Charlson Comorbidity index, ecological deprivation index, types of thyroid resection, lymph node dissection and complications, year and region, the incremental cost of overall health care utilization was €142 (p<0.004). Conclusion: Our study found a significant additional cost in respect of health expenditures for patients who had hypoparathyroidism after thyroidectomy for cancer, over the first postoperative year. Five-year follow-up is planned to assess the impact of more severe long-term complications on costs.

[Utilization of routine data from different statutory health insurance funds: a practical report of experience from the TIM-HF2 study about data acquisition, validation, and processing]. / Nutzung von Routinedaten unterschiedlicher gesetzlicher Krankenkassen: Ein Erfahrungsbericht aus der TIM-HF2-Studie zur Datenerschließung, -validierung und -aufbereitung.

BACKGROUND: The randomized controlled clinical trial "TIM-HF2" investigated the benefit of telemonitoring in chronic heart failure. The health economic evaluation of this intervention was based on routine data from statutory health insurance (SHI) funds. Since participants were recruited independently of their SHI affiliation, there was a large number of potential data-providing SHI funds. This resulted in both organizational and methodological challenges, from participation of the data providers to data preparation. METHOD: The procedures are described from study planning and data acquisition to data review and processing in the TIM-HF2 trial. Based on the identification of potential problems for data completeness and data quality, possible solutions have been derived. RESULTS: In total, participants were insured with 49 different SHI funds, which provided routine data for a total of 1450 participants. About half of all initial data deliveries were correct. The most common problems in data preparation occurred in the machine readability of the data. Success factors for a high level of data completeness were close communication with the SHI funds and a high level of time and personnel commitment to intensive data checking and preparation. DISCUSSION: Based on the experience of the TIM-HF2 trial, a high heterogeneity has been detected in data management and transmission of routine data. Universally applicable data descriptions are desired to improve data access, quality, and usability for research purposes.

Multiple micronutrient supplementation cost-benefit tool for informing maternal nutrition policy and investment decisions.

Antenatal multiple micronutrient supplementation (MMS) is an intervention that can help reach three of the six global nutrition targets, either directly or indirectly: a reduction in low birth weight, stunting, and anaemia in women of reproductive age. To support global guideline development and national decision-making on investments into maternal nutrition, Nutrition International developed a modelling tool called the MMS cost-benefit tool to help users understand whether antenatal MMS is better value for money than iron and folic acid supplementation (IFAS) during pregnancy. The MMS cost-benefit tool can generate estimates on the potential health impact, budget impact, economic value, cost-effectiveness and benefit-cost ratio of investing in MMS compared to IFAS in LMICs. In the 33 countries with data included in the tool, the MMS cost-benefit tool shows that transitioning is expected to generate substantial health benefits in terms of morbidity and mortality averted and can be very cost-effective in multiple scenarios for these countries. The cost per DALY averted averages at US$ 23.61 and benefit-cost ratio ranges from US$ 41-US$ 1304: $1.0, which suggest MMS is good value for money compared with IFAS. With its user-friendly design, open access availability, and online data-driven analytics, the MMS cost-benefit tool can be a powerful resource for governments and nutrition partners seeking timely and evidence-based analyses to inform policy-decision and investments towards the scale-up of MMS for pregnant women globally.

Cost-effectiveness analysis of sarcopenia management interventions in Iran.

OBJECTIVES: Identification the optimal management intervention of sarcopenia is a concern of health systems. We aimed to analyze the cost-effectiveness of sarcopenia management strategies in Iran. METHODS: We constructed a lifetime Markov model based on natural history. The strategies comparedincluded exercise training, nutritional supplements, whole body vibration (WBV), and various exercise interventions and nutritional supplement combinations. A total of 7 strategies was evaluated in addition to the non-intervention strategy. Parameter values were extracted from primary data and the literature, and the costs and Quality-adjusted life years (QALYs) were calculated for each strategy. Deterministic and probabilistic sensitivity analysis, including the expected value of perfect information (EVPI), was also performed to determine the robustness of the model. Analyses were performed using the 2020 version of TreeAge Pro software. RESULTS: All seven strategies increased lifetime effectiveness (QALYs). The protein and Vitamin D3 (P + D) strategy had the highest effectiveness values among all strategies. After removing the dominated strategies, the estimated ICER for the P + D compared to Vitamin D3 alone (D) strategy was calculated as $131,229. Considering the cost-effectiveness threshold ($25,249), base-case results indicated that the D strategy was the most cost-effective strategy in this evaluation. Sensitivity analysis of model parameters also demonstrated the robustness of results. Also, EVPI was estimated at $273. CONCLUSIONS: Study results, as the first economic evaluation of sarcopenia management interventions, showed that despite the higher effectiveness of D + P, the D strategy was the most cost-effective. Completing clinical evidence of various intervention options can lead to more accurate results in the future.

Health economic evaluation of preventive digital public health interventions using decision-analytic modelling: a systematized review.

BACKGROUND: Digital public health (DiPH) provides novel approaches for prevention, potentially leading to long-term health benefits in resource-limited health systems. However, cost-effectiveness of DiPH interventions is unclear. This systematized review investigates the use of decision-analytic modelling in health economic evaluations of DiPH primary prevention and health promotion interventions, focusing on intervention's design, methods used, results, and reporting quality. METHODS: PubMed, CINAHL, and Web of Science were searched for studies of decision-analytic economic evaluations of digital interventions in primary prevention or health promotion, published up to June 2022. Intervention characteristics and selected items were extracted based on the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). Incremental cost-effectiveness ratios (ICERs) were then extracted and price-adjusted to compare the economic evaluation results. Finally, the included studies' reporting quality was assessed by building a score using CHEERS. RESULTS: The database search (including search update) produced 2,273 hits. After removing duplicates, 1,434 titles and abstracts were screened. Of the 89 studies meeting the full-text search criteria, 14 were ultimately reviewed. The most common targets were physical activity (five studies) and weight loss (four). Digital applications include text messages, web-based inventions, app-based interventions, e-learning devices, and the promotion of smartphone apps. The mean ICER of the 12 studies using quality-adjusted life years (QALYs) is €20,955 per QALY (min. - €3,949; max. €114,211). The mean of reported CHEERS items per study is 81% (min. 59%; max. 91%). CONCLUSIONS: This review only includes primary prevention and health promotion, and thus excludes other DiPH fields (e.g. secondary prevention). It also focuses on decision-analytic models, excluding study-based economic evaluations. Standard methods of economic evaluation could be adapted more to the specifics of DiPH by measuring the effectiveness of more current technologies through alternative methods, incorporating a societal perspective, and more clearly defining comparators. Nevertheless, the review demonstrates using common thresholds that the new field of DiPH shows potential for cost-effective preventive interventions.

Vitamin D Fortification of Eggs Alone and in Combination with Milk in Women Aged 44-65 Years: Fortification Model and Economic Evaluation.

Introduction: For almost nine decades, the fortification of foods with vitamin D has been proven effective in preventing rickets. This study aims to build and economically evaluate a fortification model based on egg biofortification and milk (including yoghurt) fortification. Methods: A cross-sectional study was carried out between 1. March and 31. May 2021. Three hundred and nineteen healthy women from the Central Slovenian region aged between 44 and 65 were recruited for the study, with 176 participants included in the final analysis. For the fortification model calculations, the vitamin D contents of unenriched milk (including yoghurt) and eggs were replaced by enriched foods containing vitamin D. The economic evaluation was done using available drug and food supplement prices. Fortification costs were calculated using vitamin D prices provided by suppliers. Results: Mean vitamin D intake from food was 2.19±1.34 µg/d. With fortification Model 1 (enriched eggs), it would be: 6.49±4.45 µg/d, and with Model 2 (enriched eggs and milk): 10.53±6.49 µg/d. Without fortification, none of the participants would reach a daily vitamin D intake >10 µg. With fortification Model 1 (egg fortification), 15.3% would reach >10 µg and with Model 2 (egg and milk fortification) 46.2% would reach >10 µg. The economic comparison of the annual cost of 10 µg vitamin D/d/person was EUR 6.17 for prescription drugs, EUR 6.37 for food supplements, EUR 0.09 for direct milk fortification and EUR 0.12 for egg biofortification with vitamin D. Conclusions: Egg and milk (including yoghurt) fortification could cost-effectively increase vitamin D intake in the Slovenian population of women between 44 and 65 by almost five-fold, and could significantly lower the prevalence of vitamin D deficiency. Additional research and changes to legislation are needed before this can be introduced.