Accounting for planetary boundaries in health economic evaluation.

INTRODUCTION: Health economic evaluation (HEE) provides guidance for decision-making in the face of scarcity but ignores ecological scarcities as long as they involve external costs only. Following the imperative to account for planetary health, this study explores how this blind spot can be addressed. AREAS COVERED: The study is based on a critical review of relevant work, particularly in the fields of HEE and life cycle assessment (LCA). LCA can provide information on a technology's environmental impacts which can be accounted for on both the effect and cost sides of HEE. Cost-benefit analyses can incorporate environmental impacts in case vignettes used for eliciting consumers' willingness to pay. Existing LCA impact models can be used to estimate human health risks associated with environmental impacts and add them to the health benefits in cost-utility analyses. Many jurisdictions offer lists of shadow prices that can be used to incorporate environmental impacts on the cost side of HEE. Also, environmental impacts can be reported in a disaggregated manner. EXPERT OPINION: Accounting for planetary boundaries is likely to become a key field of methodological innovation in HEE. Decision relevance is likely to be highest for technologies with similar cost-effectiveness but different ecological impacts.

[Mental health problems among employees: service use and costs to the German healthcare system]. / Psychische Belastungen bei Erwerbstätigen: Leistungsinanspruchnahme und Kosten für das deutsche Gesundheitssystem.

BACKGROUND: Service use among employees with mental health problems and the associated costs for the health and social system have not yet been systematically analysed in studies or have only been recorded indirectly. The aim of this article is to report the service use in this target group, to estimate the costs for the health and social system and to identify possible influencing factors on the cost variance. METHODS: As part of a multicentre study, use and costs of health and social services were examined for a sample of 550 employees with mental health problems. Service use was recorded using the German version of the Client Sociodemographic Service Receipt Inventory (CSSRI). Costs were calculated for six months. A generalized linear regression model was used to examine influencing cost factors. RESULTS: At the start of the study, the average total costs for the past six months in the sample were €â€¯5227.12 per person (standard deviation €â€¯7704.21). The regression model indicates significant associations between increasing costs with increasing age and for people with depression, behavioural syndromes with physiological symptoms, and other diagnoses. DISCUSSION: The calculated costs were similar in comparison to clinical samples. It should be further examined in longitudinal studies whether this result changes through specific interventions.

Economic evaluation of second measles containing vaccine (MCV) dose: a systematic review of available evidence.

INTRODUCTION: The global measles incidence has decreased from 145 to 49 cases per 1 million population from 2000 to 2018, but evaluating the economic benefits of a second measles-containing vaccine (MCV2) is crucial. This study reviewed the evidence and quality of economic evaluation studies to guide MCV2 introduction. METHODS: The systematic review of model-based economic evaluation studies was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search yielded 2231 articles, with 876 duplicates removed and 1355 articles screened, with nine studies included for final analysis. RESULTS: Six studies reported a positive benefit-cost ratio with one resulting in net savings of $11.6 billion, and two studies estimated a 2-dose MMR vaccination program would save $119.24 to prevent one measles case, and a second dose could prevent 9,200 cases at 18 months, saving $548.19 per case. The most sensitive variables were the discount rate and vaccination administration cost. CONCLUSIONS: Two MCV doses or a second opportunity with an additional dose of MCV were highly cost-beneficial and resulted in substantial cost savings compared to a single routine vaccine. But further research using high-quality model-based health economic evaluation studies of MCV2 should be made available to decision-makers. PROSPERO REGISTRATION: CRD42020200669.

Health Economic Evaluation of Patients With Colorectal Liver Metastases Randomized to ALPPS or TSH: Analysis From the LIGRO Trial.

Objective: This is a preplanned, health economic evaluation from the LIGRO trial. One hundred patients with colorectal liver metastases (CRLM) and standardized future liver remnant <30% were randomized to associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) or two-staged hepatectomy (TSH). Summary Background Data: TSH, is an established method in advanced CRLM. ALPPS has emerged providing improved resection rate and survival. The health care costs and health outcomes, combining health-related quality of life (HRQoL) and survival into quality-adjusted life years (QALYs), of ALPPS and TSH have not previously been evaluated and compared. Methods: Costs and QALYs were compared from treatment start up to 2 years. Costs are estimated from resource use, including all surgical interventions, length of stay after interventions, diagnostic procedures and chemotherapy, and applying Swedish unit costs. QALYs were estimated by combining survival and HRQoL data, the latter being assessed with EQ-5D 3L. Estimated costs and QALYs for each treatment strategy were combined into an incremental cost-effectiveness ratio (ICER). Nonparametric bootstrapping was used to assess the joint distribution of incremental costs and QALYs. Results: The mean cost difference between ALPPS and TSH was 12,662€, [95% confidence interval (CI): -10,728-36,051; P = 0.283]. Corresponding mean difference in life years and QALYs was 0.1296 (95% CI: -0.12-0.38; P = 0.314) and 0.1285 (95% CI: -0.11-0.36; P = 0.28), respectively. The ICER was 93,186 and 92,414 for QALYs and life years as outcomes, respectively. Conclusions: Based on the 2-year data, the cost-effectiveness of ALPPS is uncertain. Further research, exploring cost and health outcomes beyond 2 years is needed.

Consolidated Health Economic Evaluation Reporting Standards for Interventions That Use Artificial Intelligence (CHEERS-AI).

OBJECTIVES: Economic evaluations (EEs) are commonly used by decision makers to understand the value of health interventions. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022) provide reporting guidelines for EEs. Healthcare systems will increasingly see new interventions that use artificial intelligence (AI) to perform their function. We developed Consolidated Health Economic Evaluation Reporting Standards for Interventions that use AI (CHEERS-AI) to ensure EEs of AI-based health interventions are reported in a transparent and reproducible manner. METHODS: Potential CHEERS-AI reporting items were informed by 2 published systematic literature reviews of EEs and a contemporary update. A Delphi study was conducted using 3 survey rounds to elicit multidisciplinary expert views on 26 potential items, through a 9-point Likert rating scale and qualitative comments. An online consensus meeting was held to finalize outstanding reporting items. A digital health patient group reviewed the final checklist from a patient perspective. RESULTS: A total of 58 participants responded to survey round 1, 42, and 31 of whom responded to rounds 2 and 3, respectively. Nine participants joined the consensus meeting. Ultimately, 38 reporting items were included in CHEERS-AI. They comprised the 28 original CHEERS 2022 items, plus 10 new AI-specific reporting items. Additionally, 8 of the original CHEERS 2022 items were elaborated on to ensure AI-specific nuance is reported. CONCLUSIONS: CHEERS-AI should be used when reporting an EE of an intervention that uses AI to perform its function. CHEERS-AI will help decision makers and reviewers to understand important AI-specific details of an intervention, and any implications for the EE methods used and cost-effectiveness conclusions.

Health economic evaluation of 2-dose and 3-dose rotavirus vaccines in children below 5 years of age in Morocco.

Following the introduction of rotavirus vaccination into the Moroccan National Immunization Program, the prevalence of the disease has decreased by nearly 50%. However, evidence on the economic value of rotavirus vaccinations in Morocco is limited. This health economic analysis evaluated, from both country payer and societal perspectives, the costs and the cost-effectiveness of three rotavirus vaccines using a static, deterministic, population model in children aged < 5 years in Morocco. Included vaccines were HRV (2-dose schedule), HBRV (3-dose schedule) and BRV-PV 1-dose vial (3-dose schedule). One-way and probabilistic sensitivity analyses were conducted to assess the impact of uncertainty in model inputs. The model predicted that vaccination with HRV was estimated to result in fewer rotavirus gastroenteritis events (-194 homecare events, -57 medical visits, -8 hospitalizations) versus the 3-dose vaccines, translating into 7 discounted quality-adjusted life years gained over the model time horizon. HRV was associated with lower costs versus HBRV from both the country payer (-$1.8 M) and societal (-$4.1 M) perspectives, and versus BRV-PV 1-dose vial from the societal perspective (-$187,000), dominating those options in the cost-effectiveness analysis. However, costs of BRV-PV 1-dose vial were lower than HRV from the payer perspective, resulting in an ICER of approximately $328,376 per QALY, above the assumed cost effectiveness threshold of $3,500. Vaccination with a 2-dose schedule of HRV may be a cost-saving option and could lead to better health outcomes for children in Morocco versus 3-dose schedule rotavirus vaccines.

The economic impact of anastomotic leakage after colorectal surgery: a systematic review.

BACKGROUND: Anastomotic leakage (AL) remains a burdensome complication following colorectal surgery, with increased morbidity, oncological compromise, and mortality. AL may impose a substantial financial burden on hospitals and society due to extensive resource utilization. Estimated costs associated with AL are important when exploring preventive measures and treatment strategies. The purpose of this study was to systematically review the existing literature on (socio)economic costs associated with AL after colorectal surgery, appraise their quality, compare reported outcomes, and identify knowledge gaps. METHODS: Health economic evaluations reporting costs related to AL after colorectal surgery were identified through searching multiple online databases until June 2023. Pairs of reviewers independently evaluated the quality using an adapted version of the Consensus on Health Economic Criteria list. Extracted costs were converted to 2022 euros (€) and also adjusted for purchasing power disparities among countries. RESULTS: From 1980 unique abstracts, 59 full-text publications were assessed for eligibility, and 17 studies were included in the review. The incremental costs of AL after correcting for purchasing power disparity ranged from €2250 (+39.9%, Romania) to €83,633 (+ 513.1%, Brazil). Incremental costs were mainly driven by hospital (re)admission, intensive care stay, and reinterventions. Only one study estimated the economic societal burden of AL between €1.9 and €6.1 million. CONCLUSIONS: AL imposes a significant financial burden on hospitals and social care systems. The magnitude of costs varies greatly across countries and data on the societal burden and non-medical costs are scarce. Adherence to international reporting standards is essential to understand international disparities and to externally validate reported cost estimates.

Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care - Protocol for a health economic evaluation alongside a randomized controlled trial.

BACKGROUND: Prehabilitation aims to improve patients' functional capacity before surgery to reduce perioperative complications, promote recovery and decrease probability of disability. The planned economic evaluation is performed alongside a large German multi-centre pragmatic, two-arm parallel-group, randomized controlled trial on prehabilitation for frail elderly patients before elective surgery compared to standard care (PRAEP-GO RCT). The aim is to determine the cost-effectiveness and cost-utility of prehabilitation for frail elderly before an elective surgery. METHODS: The planned health economic evaluation comprises cost-effectiveness, and cost-utility analyses. Analyses are conducted in the German context from different perspectives including the payer perspective, i.e. the statutory health insurance, the societal perspective and the health care provider perspective. Data on outcomes and costs, are collected alongside the ongoing PRAEP-GO RCT. The trial population includes frail or pre-frail patients aged ≥70 years with planned elective surgery. The intervention consists of frailty screening (Fried phenotype), a shared decision-making conference determining modality (physiotherapy and unsupervised physical exercises, nutrition counselling, etc.) and setting (inpatient, day care, outpatient etc.) of a 3-week individual multimodal prehabilitation prior to surgery. The control group receives standard preoperative care. Costs include the intervention costs, the costs of the index hospital stay for surgery, and health care resources consumed during a 12-month follow-up. Clinical effectiveness outcomes included in the economic evaluation are the level of care dependency, the degree of disability as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality-adjusted life years (QALY) derived from the EQ-5D-5L and the German utility set, and complications occurring during the index hospital stay. Each adopted perspective considers different types of costs and outcomes as outlined in the protocol. All analyses will feature Intention-To-Treat analysis. To explore methodological and parametric uncertainties, we will conduct probabilistic and deterministic sensitivity analyses. Subgroup analyses will be performed as secondary analyses. DISCUSSION: The health economic evaluation will provide insights into the cost-effectiveness of prehabilitation in older frail populations, informing decision-making processes and contributing to the evidence base in this field. Potential limitation includes a highly heterogeneous trial population. TRIAL REGISTRATION: PRAEP-GO RCT: NCT04418271; economic evaluation: OSF ( https://osf.io/ecm74 ).

Mapping of Family Reported Outcome Measure (FROM-16) scores to EQ-5D: algorithm to calculate utility values.

OBJECTIVE: Although decision scientists and health economists encourage inclusion of family member/informal carer utility in health economic evaluation, there is a lack of suitable utility measures comparable to patient utility measures such those based on the EQ-5D. This study aims to predict EQ-5D-3L utility values from Family Reported Outcome Measure (FROM-16) scores, to allow the use of FROM-16 data in health economic evaluation when EQ-5D data is not available. METHODS: Data from 4228 family members/partners of patients recruited to an online cross-sectional study through 58 UK-based patient support groups, three research support platforms and Welsh social services departments were randomly divided five times into two groups, to derive and test a mapping model. Split-half cross-validation was employed, resulting in a total of ten multinomial logistic regression models. The Monte Carlo simulation procedure was used to generate predicted EQ-5D-3L responses, and utility scores were calculated and compared against observed values. Mean error and mean absolute error were calculated for all ten validation models. The final model algorithm was derived using the entire sample. RESULTS: The model was highly predictive, and its repeated fitting using multinomial logistic regression demonstrated a stable model. The mean differences between predicted and observed health utility estimates ranged from 0.005 to 0.029 across the ten modelling exercises, with an average overall difference of 0.015 (a 2.2% overestimate, not of clinical importance). CONCLUSIONS: The algorithm developed will enable researchers and decision scientists to calculate EQ-5D health utility estimates from FROM-16 scores, thus allowing the inclusion of the family impact of disease in health economic evaluation of medical interventions when EQ-5D data is not available.

Economic evaluation of management strategies for complex regional pain syndrome (CRPS).

Background: The economic impact of Complex Regional Pain Syndrome (CRPS) on both patients and the global healthcare system continues to escalate. However, the economic implications associated with management interventions for CRPS have received limited attention. Therefore, our objective is to perform a thorough examination of published economic assessments of the various management strategies utilized for CRPS. Methods: A thorough search spanning four general medical databases and three health economic databases to identify full economic evaluations on CRPS management strategies from January 1994 to June 2023 were conducted. The quality of these studies were evaluated by employing the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. To enable cross-study comparisons conducted in different countries, we adjusted the costs reported in the selected studies for inflation and converted them into 2023 US dollars. Results: A total of nine economic evaluations, consisting of eight high-quality and one medium-quality, were identified across five nations during a span of 29 years. The findings suggest that the most economically efficient intervention for CRPS are interventional approaches of Spinal Cord Stimulation (SCS) in comparison to conventional management for long periods of time. Furthermore, in situations where there is a limited time period of less than 1 year, rehabilitation therapies, particularly physical therapy, have been demonstrated to be more effective in terms of both cost and clinical outcomes. Conclusion: The interventional management strategies, particularly for severe and persistent CRPS over long periods, may offer the greatest cost efficiency. In conditions with limited timelines, rehabilitation measures, such as rehabilitation therapies, can be cost-effective. However, insufficient data for other common interventions prevents the formation of a definitive conclusion. Similarly, it is crucial to recognize that the results of these interventions might be affected by the selection of comparator and the threshold for willingness to pay.

The Checklist for Standard Methodological Requirements and Reporting of Economic Evaluation of Medicines in Slovakia.

OBJECTIVES: We have developed a scientifically well-grounded, methodological, and reporting checklist for economic evaluation (EE) of medicines in the Slovak health technology assessment process, which serves as a supplement to the Slovak pharmacoeconomic guidelines. METHODS: The checklist was developed using an iterative process in which items were generated and gradually added to the baseline checklist based on shortcomings identified in an analysis of Slovak EEs, using relevant published checklists, and Slovak, as well as international, methodological guidance that was identified in the systematic literature review. The selection of checklist recommendations, their clarity, and relevance to the Slovak setting were validated in the online survey. RESULTS: From the sample of 151 price and reimbursement submissions published between January 2018 and July 2021, almost half of them (n = 73) received at least 1 request from the Ministry of Healthcare to justify or modify the methodology used in the EE; and in 18 proceedings, a negative opinion was issued because of shortcomings identified in the EE. The 25-items preliminary checklist, resulting from an iterative working process, has been validated in an online survey conducted among members of ISPOR Chapter Slovakia. After incorporating relevant comments, the final proposal for the Slovak checklist consists of 55 recommendations. CONCLUSIONS: The research represented the first attempt to create a Slovak EE checklist, which serves as a part of ISPOR Slovakia pharmacoeconomic guidelines. Implementation of the checklist allows checking whether EE meets legislative and methodological requirements and thus helps in improving the appropriateness and standardization of EEs in Slovakia.

Long-term outcomes and cost-effectiveness evaluation of robot-assisted stereotactic hematoma drainage for spontaneous intracerebral hemorrhage.

Background: To investigate the long-term follow-up and economic estimation outcomes of hematoma drainage for spontaneous intracerebral hemorrhage (SICH) with the assistance of neurosurgical navigation and positioning planning system (referred to as robot). Methods: Data were retrospectively obtained from consecutive patients with SICH who were admitted to our single-center between March 2019 and March 2022. Different minimally invasive surgery (MIS) procedures were performed according to the inclusion/exclusion criteria. The different groups were sampled and matched using the propensity score method, with age, sex, history of stroke, hypertension, bleeding volume and site of bleeding as matching variables, and matched with inverse probability weighting using R statistical analysis software. From the time of discharge up until 1 year after the surgery, records were gathered on clinical results and medical expenditures. An analysis was conducted to compare the costs and health outcomes of both robot-assisted stereotactic hematoma drainage and neuro-endoscopic surgery, considering both short-term and long-term effects. Health outputs were measured using modified Rankin scale (mRS) and quality adjusted life years (QALYs). Results: Of the 142 patients, there were 77 patients in the robotic surgery group and 65 patients in the neuro-endoscopic surgery group. Propensity score sampling was matched, resulting in a balanced and comparable group of 37 patients in each, with the robotic surgery group [mean age (57.29 ± 12.74) years, 27 males (72.97%), hematoma volume (44.54 ± 10.49 ml), 22 deep location (59.46%)] and the neuro-endoscopic surgery group [mean age (57.27 ± 11.12) years, 27 males (72.97%), hematoma volume (44.70 ± 10.86 ml), 23 deep location (62.16%)]. At both three-month and one-year postoperative follow-up, the proportion of mRS scores ≤3 was higher in the robotic surgery group (45.95%,70.27%) than in the neuro-endoscopic surgery group (35.14%, 62.16%), but there was no statistically significant difference (P = 0.344, 0.461). One year after surgery, the robotic group demonstrated cost savings of ¥36,862.14 per individual and a gain of 0.062 QALYs compared to the neuro-endoscopic group. Conclusion: Our calculations based on a model for SICH suggest that robotic-assisted stereotactic drainage offers health economic benefits due to its lower cost and higher effectiveness. However, to confirm these findings, more data from multicenter, prospective randomized controlled trials with larger sample sizes are needed.

The cost-utility of an intervention for children and adolescents with a parent having a mental illness in the framework of the German health and social care system: a health economic evaluation of a randomized controlled trial.

BACKGROUND: Children of families with a parent with a mental illness have an increased risk of developing social and mental health problems resulting in decreased quality of life. Therefore, children and adolescents living in families with a parent with mental illness are regarded as a target group for preventive interventions. To date, only a few economic evaluation studies for interventions directed at preventing the intergenerational transmission of mental health problems exist. In this investigation we estimated the cost utility of an intervention for the support of children and adolescents with a parent having a mental illness from the perspective of the German health and social care system. METHODS: We randomly assigned a total of 214 families with 337 children and adolescents to the intervention (INT) group (108/170) or the control (TAU) group (106/167). Families in the intervention group received on average eight intervention sessions (50-90 min) over 6 months. We estimated total cost of illness by means of the Children and Adolescent Mental Health Service Receipt Inventory (CAMHSRI) over 24 months. For the estimation of Quality-Adjusted Live Years (QALYs) we applied the KIDSCREEN-10. For estimating the incremental cost-utility of the intervention compared to treatment as usual we used the net-benefit approach. RESULTS: We estimated the annual cost of illness amounting to € 3784.59 (SD € 8581.11) in the TAU group and € 3264.44 (SD € 9431.89) in the INT group. The annual cost difference between INT and TAU was € - 516.14 (SE 1124.95) which was not significant (p ≤ 0.05). We estimated the average QALY to be 0.759 (SD 0.073) in the TAU group and 0.763 (SD 0.072). The QALY difference between INT and TAU was 0.0037 (SE 0.0092) which was not significant (p ≤ 0.05). The incremental cost utility ratio (ICUR) indicated that the gain of one additional year in full health by means of the intervention was associated with the saving of € 139.49. However, the stochastic insecurity of the ICUR did not allow a unique decision about the cost-utility of the intervention. CONCLUSIONS: More information on the economic value of the intervention for families with a parent with mental illness in comparison to treatment as usual in Germany is needed. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT02308462; German Clinical Trials Register: DRKS00006806.

Impact of Long COVID on productivity and informal caregiving.

BACKGROUND: Around 2 million people in the UK suffer from Long COVID (LC). Of concern is the disease impact on productivity and informal care burden. This study aimed to quantify and value productivity losses and informal care receipt in a sample of LC patients in the UK. METHODS: The target population comprised LC patients referred to LC specialist clinics. The questionnaires included a health economics questionnaire (HEQ) measuring productivity impacts, informal care receipt and service utilisation, EQ-5D-5L, C19-YRS LC condition-specific measure, and sociodemographic and COVID-19 history variables. Outcomes were changes from the incident infection resulting in LC to the month preceding the survey in paid work status/h, work income, work performance and informal care receipt. The human capital approach valued productivity losses; the proxy goods method valued caregiving hours. The values were extrapolated nationally using published prevalence data. Multilevel regressions, nested by region, estimated associations between the outcomes and patient characteristics. RESULTS: 366 patients responded to HEQ (mean LC duration 449.9 days). 51.7% reduced paid work hours relative to the pre-infection period. Mean monthly work income declined by 24.5%. The average aggregate value of productivity loss since incident infection was £10,929 (95% bootstrap confidence interval £8,844-£13,014) and £5.7 billion (£3.8-£7.6 billion) extrapolated nationally. The corresponding values for informal caregiving were £8,726 (£6,247-£11,204) and £4.8 billion (£2.6-£7.0 billion). Multivariate analyses found significant associations between each outcome and health utility and C19-YRS subscale scores. CONCLUSION: LC significantly impacts productivity losses and provision of informal care, exacerbated by high national prevalence of LC.

Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation.

Background: Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online. Objective: To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders. Design: Single-blind, parallel-group, randomised controlled trial, with 3-month (primary end point) and 6-month post-randomisation follow-up. Participants were individually randomised (1 : 1), using on online system, with block randomisations, stratified by site. Naturalistic follow-up was conducted at 12 and 18 months post-randomisation when participants were free to access non-trial interventions. A subset of participants participated in a process evaluation. Setting: Two hospitals (London and Nottingham) in England also accepting referrals from patient identification centres and online self-referrals. Participants: Children aged 9-17 years (1) with Tourette syndrome or chronic tic disorder, (2) with a Yale Global Tic Severity Scale-total tic severity score of 15 or more (or > 10 with only motor or vocal tics) and (3) having not received behavioural therapy for tics in the past 12 months or started/stopped medication for tics within the past 2 months. Interventions: Either 10 weeks of online, remotely delivered, therapist-supported exposure and response prevention therapy (intervention group) or online psychoeducation (control). Outcome: Primary outcome: Yale Global Tic Severity Scale-total tic severity score 3 months post-randomisation; analysis done in all randomised patients for whom data were available. Secondary outcomes included low mood, anxiety, treatment satisfaction and health resource use. Quality-adjusted life-years are derived from parent-completed quality-of-life measures. All trial staff, statisticians and the chief investigator were masked to group allocation. Results: Two hundred and twenty-four participants were randomised to the intervention (n = 112) or control (n = 112) group. Participants were mostly male (n = 177; 79%), with a mean age of 12 years. At 3 months the estimated mean difference in Yale Global Tic Severity Scale-total tic severity score between the groups adjusted for baseline and site was -2.29 points (95% confidence interval -3.86 to -0.71) in favour of therapy (effect size -0.31, 95% confidence interval -0.52 to -0.10). This effect was sustained throughout to the final follow-up at 18 months (-2.01 points, 95% confidence interval -3.86 to -0.15; effect size -0.27, 95% confidence interval -0.52 to -0.02). At 18 months the mean incremental cost per participant of the intervention compared to the control was £662 (95% confidence interval -£59 to £1384), with a mean incremental quality-adjusted life-year of 0.040 (95% confidence interval -0.004 to 0.083) per participant. The mean incremental cost per quality-adjusted life-year gained was £16,708. The intervention was acceptable and delivered with high fidelity. Parental engagement predicted child engagement and more positive clinical outcomes. Harms: Two serious, unrelated adverse events occurred in the control group. Limitations: We cannot separate the effects of digital online delivery and the therapy itself. The sample was predominately white and British, limiting generalisability. The design did not compare to face-to-face services. Conclusion: Online, therapist-supported behavioural therapy for young people with tic disorders is clinically and cost-effective in reducing tics, with durable benefits extending up to 18 months. Future work: Future work should compare online to face-to-face therapy and explore how to embed the intervention in clinical practice. Trial registration: This trial is registered as ISRCTN70758207; ClinicalTrials.gov (NCT03483493). The trial is now complete. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Technology Assessment programme (project number 16/19/02) and will be published in full in Health and Technology Assessment; Vol. 27, No. 18. See the NIHR Journals Library website for further project information.

It can be difficult for children and young people with tics to access therapy. This is because there are not enough trained tic therapists. Online remote behavioural intervention for tics was a clinical trial to see whether an online platform that delivered two different types of interventions could help tics. One intervention focused on techniques to control tics; this type of therapy is called exposure and response prevention. The other intervention was psychoeducation, where participants learned about the nature of tics but not how to control them. The online remote behavioural intervention for tics interventions also involved help from a therapist and support from a parent. Participants were aged 9­17 years with Tourette syndrome/chronic tic disorder and were recruited from 16 clinics, two study sites (Nottingham and London) or via online self-referral. All individuals who were eligible for the online remote behavioural intervention for tics trial were randomised in a 50/50 split by researchers who were unaware of which treatment was being given. Participants received either 10 weeks of online exposure and response prevention or 10 weeks of online psychoeducation. A total of 224 children and young people participated: 112 allocated to exposure and response prevention and 112 to psychoeducation. Tics decreased more in the exposure and response prevention group (16% reduction) than in the psychoeducation group (6% reduction) 3 months after treatment. This difference is considered a clinically important difference in tic reduction. The treatment continued to have a positive effect on tic symptoms at 6, 12 and 18 months, showing that the effects are durable. This was achieved with minimal therapist involvement. The cost of online exposure and response prevention to treat young people with tics within this study was less when compared to the cost of face-to-face therapy. The results show that exposure and response prevention is an effective behavioural therapy for tics in this specific patient group. Delivering exposure and response prevention online with minimal therapist contact can be a successful and cost-effective treatment to improve access to behavioural therapy.

The influence of COVID-19 epidemic on the number of orthopaedic surgeries in Japan.

BACKGROUND: There is limited data on the impact of COVID-19 epidemic on the number of orthopaedic surgeries in Japan. METHODS: We conducted a nationwide hospital survey asking for the monthly number of orthopaedic surgeries performed at each facility from January 2019 to June 2021. Those facilities that had performed at least 100 surgeries in 2019 were included for analyses. The facilities were further grouped by prefecture and by hospital characteristics. A brief health economic evaluation was also performed. Risk ratios were compared using univariate analyses with P < 0.05 considered statistically significant. RESULTS: Questionnaire was sent to 1988 hospitals with 1671 hospitals (84%) responding. The survey data indicated a total number of orthopaedic surgeries decreased in 2020 compared to 2019 (1,061,541 vs 1,119,955 P < 0.01), and also for the first six months of 2021 compared to the same period in 2019 (530,388 vs 550,378 P < 0.01). In 2020, over 50% of all facilities in nearly all of the prefectures saw a decline in surgical procedures. The risk of incurring more than a 25% decease in the number of surgeries was significantly higher in 2020 for class I designated medical institutions compared to those that were not designated for any types of infectious diseases among the institutions with a tertiary emergency medical center in 2020 (crude risk ratio 2.9: 95% CI 1.2-7.4, p = 0.02) and in 2021 (crude risk ratio 4.7: 95% CI 1 0.9-12.1, p < 0.01). The estimated total nationwide decrease of revenue were in the range of approximately ¥29.2 to ¥116.8 billion per year for orthopaedic surgeries alone. CONCLUSION: There was a statistically significant decrease in the number of orthopaedic surgeries in Japan. The magnitude of the decline varied by prefectures and hospital characteristics, with the greater impact imposed on medical institutions with higher classification functions. The estimated immediate health economic impact was sizable.

Economic evaluations of artificial intelligence-based healthcare interventions: a systematic literature review of best practices in their conduct and reporting.

Objectives: Health economic evaluations (HEEs) help healthcare decision makers understand the value of new technologies. Artificial intelligence (AI) is increasingly being used in healthcare interventions. We sought to review the conduct and reporting of published HEEs for AI-based health interventions. Methods: We conducted a systematic literature review with a 15-month search window (April 2021 to June 2022) on 17th June 2022 to identify HEEs of AI health interventions and update a previous review. Records were identified from 3 databases (Medline, Embase, and Cochrane Central). Two reviewers screened papers against predefined study selection criteria. Data were extracted from included studies using prespecified data extraction tables. Included studies were quality assessed using the National Institute for Health and Care Excellence (NICE) checklist. Results were synthesized narratively. Results: A total of 21 studies were included. The most common type of AI intervention was automated image analysis (9/21, 43%) mainly used for screening or diagnosis in general medicine and oncology. Nearly all were cost-utility (10/21, 48%) or cost-effectiveness analyses (8/21, 38%) that took a healthcare system or payer perspective. Decision-analytic models were used in 16/21 (76%) studies, mostly Markov models and decision trees. Three (3/16, 19%) used a short-term decision tree followed by a longer-term Markov component. Thirteen studies (13/21, 62%) reported the AI intervention to be cost effective or dominant. Limitations tended to result from the input data, authorship conflicts of interest, and a lack of transparent reporting, especially regarding the AI nature of the intervention. Conclusion: Published HEEs of AI-based health interventions are rapidly increasing in number. Despite the potentially innovative nature of AI, most have used traditional methods like Markov models or decision trees. Most attempted to assess the impact on quality of life to present the cost per QALY gained. However, studies have not been comprehensively reported. Specific reporting standards for the economic evaluation of AI interventions would help improve transparency and promote their usefulness for decision making. This is fundamental for reimbursement decisions, which in turn will generate the necessary data to develop flexible models better suited to capturing the potentially dynamic nature of AI interventions.

Health Economic Evaluation of Cognitive Control Training for Depression: Key Considerations.

Depression is a serious and burdensome psychiatric illness that contributes heavily to health expenditures. These costs are partly related to the observation that depression is often not limited to a single episode but can recur or follow a chronic pathway. In terms of risk factors, it is acknowledged that cognitive impairments play a crucial role in vulnerability to depression. Within this context, cognitive control training (CCT) has shown its effectiveness in reducing the risk for recurrence of depression. CCT is low cost intensive and can be provided as a web-based intervention, which makes it easy to disseminate. Despite increasing interest in the field, studies examining the cost-effectiveness of CCT in the context of depression are largely missing. Health economic evaluation (HEE) allows to inform decision makers with evidence-based insights about how to spend limited available (financial) resources in the most efficient way. HEE studies constitute a crucial step in the implementation of a new intervention in clinical practice. Approaching preventive measures for depression such as CCT from an HEE perspective is informative to health policy, fostering optimal use of health expenditures. The aim of this paper was to inform and guide researchers during the phase of designing HEE studies in the context of CCT for depression. A clear view of CCT's cost-effectiveness is paramount for its clinical implementation.

The value of correctly diagnosing axial spondyloarthritis for patients and society.

OBJECTIVE: To demonstrate the value of diagnosing axSpA, by comparing health and costs associated with available diagnostic algorithms and perfect diagnosis. METHODS: Using data from SPACE and other cohorts, a model was developed to estimate health (quality-adjusted life-years, QALYs) and costs (healthcare consumption and work productivity losses) of different diagnostic algorithms for axSpA amongst patients with low back pain referred to a rheumatologist, over a 60-year horizon. The model combined a decision-tree (diagnosis) with a state-transition model (treatment). The three algorithms (Berlin [BER, highest specificity], Modification 1 [M1; less strict inflammatory back pain (IBP) criterion] and Modification 2 [M2; IBP not mandatory as entry criterion, highest sensitivity]) were compared. Changes in sensitivity/specificity were explored and the value of perfect diagnosis was investigated. RESULTS: For each correctly diagnosed axSpA patient, up to 4.7 QALYs and €60,000 could be gained/saved, considering a societal perspective. Algorithm M2 resulted in more health and lower costs per patient (24.23 QALYs; €157,469), compared to BER (23.96 QALYs; €159,423) and M1 (24.15 QALYs; €158,417). Hypothetical improvements in M2 sensitivity resulted in slightly more value compared to improvements in specificity. Perfect diagnosis can cost €7,500 per patient and still provide enough value. CONCLUSION: Correct diagnosis of axSpA results in substantial health and cost benefits for patients and society. Not requiring IBP as mandatory for diagnosis of axSpA (algorithm M2) provides more value and would be preferable. A considerably more expensive diagnostic algorithm with better accuracy than M2 would still be considered good value for money.