Trial-based Economic Evaluation Research Articles

Cost-effectiveness of scar management post-burn: a trial-based economic evaluation of three intervention models

Optimal burn scar management has the potential to markedly improve the lives of children, but can require substantial healthcare resources. The study aimed to examine the cost-effectiveness of three scar management interventions: pressure garment; topical silicone gel; combined pressure garment and topical silicone gel therapy, alongside a randomised controlled trial of these interventions. Participants were children (n = 153) referred for burn scar management following grafting, spontaneous healing after acute burn injury, or reconstructive surgery. Healthcare resource use was costed from a health service perspective (6-months post-burn time-horizon). The mean total scar management cost was lowest in the topical silicone gel group ($382.87 (95% CI $337.72, $443.29)) compared to the pressure garment ($1327.02 (95% CI $1081.46, $1659.95)) and combined intervention $1605.97 ($1077.65, $2694.23)) groups. There were no significant between-group differences in Quality Adjusted Life Year estimates. There was a 70% probability that topical silicone gel dominated pressure garment therapy (was cheaper and more effective), a 29% probability that pressure garment therapy dominated combined therapy, and a 63% probability that topical silicone gel dominated combined therapy. In conclusion, topical silicone gel was the cheaper intervention, and may be favoured in the absence of clear clinical effect favouring pressure garment therapy or a combination of these management approaches.Trial registration: ACTRN12616001100482 (prospectively registered).

The handling of missing data in trial-based economic evaluations: should data be multiply imputed prior to longitudinal linear mixed-model analyses?

IntroductionFor the analysis of clinical effects, multiple imputation (MI) of missing data were shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to trial-based economic evaluations. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost and effect data.MethodsTwo-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10, 25, and 50% missing data in follow-up costs and effects, assuming a Missing At Random (MAR) mechanism. Six different strategies were compared using empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). These strategies were: LLM alone (LLM) and MI with LLM (MI-LLM), and, as reference strategies, mean imputation with LLM (M-LLM), seemingly unrelated regression alone (SUR-CCA), MI with SUR (MI-SUR), and mean imputation with SUR (M-SUR).ResultsFor costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, SUR-CCA, and M-SUR, with smaller EBs and RMSEs as well as CRs closers to nominal levels. However, even though LLM, MI-LLM and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 and 25% missing data. At 50% missing data, all strategies resulted in relatively high EBs and RMSEs for costs.ConclusionLLM should be combined with MI when analyzing trial-based economic evaluation data. MI-SUR is more efficient and can also be used, but then an average intervention effect over time cannot be estimated.

Economic evaluation of a multi-strategy intervention that improves school-based physical activity policy implementation

BackgroundInternationally, government policies mandating schools to provide students with opportunities to participate in physical activity are poorly implemented. The multi-component Physically Active Children in Education (PACE) intervention effectively assists schools to implement one such policy. We evaluated the value of investment by health service providers tasked with intervention delivery, and explored where adaptations might be targeted to reduce program costs for scale-up.MethodsA prospective trial-based economic evaluation of an implementation intervention in 61 primary schools in New South Wales (NSW), Australia. Schools were randomised to the PACE intervention or a wait-list control. PACE strategies included centralised technical assistance, ongoing consultation, principal's mandated change, identifying and preparing in-school champions, educational outreach visits, and provision of educational materials and equipment. Effectiveness was measured as the mean weekly minutes of physical activity implemented by classroom teachers, recorded in a daily log book at baseline and 12-month follow-up. Delivery costs (reported in $AUD, 2018) were evaluated from a public finance perspective. Cost data were used to calculate: total intervention cost, cost per strategy and incremental cost (overall across all schools and as an average per school). Incremental cost-effectiveness ratios (ICERs) were calculated as the incremental cost of delivering PACE divided by the estimated intervention effect.ResultsPACE cost the health service provider a total of $35,692 (95% uncertainty interval [UI] $32,411, $38,331) to deliver; an average cost per school of $1151 (95%UI $1046, $1236). Training in-school champions was the largest contributor: $19,437 total; $627 ($0 to $648) average per school. Educational outreach was the second largest contributor: $4992 total; $161 ($0 to $528) average per school. The ICER was $29 (95%UI $17, $64) for every additional minute of weekly physical activity implemented per school.ConclusionPACE is a potentially cost-effective intervention for increasing schools implementation of a policy mandate. The investment required by the health service provider makes use of existing funding and infrastructure; the additional cost to assist schools to implement the policy is likely not that much. PACE strategies may be adapted to substantially improve delivery costs.Trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12617001265369; Prospectively registered 1st September 2017 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373520

Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up

IntroductionPatients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a...

Cost and Cost Effectiveness of a Pilot m-Health Intervention Targeting Parents of School-Aged Children to Improve the Nutritional Quality of Foods Packed in the Lunchbox.

The SWAP IT program aims to improve the nutritional quality of school lunchboxes via a multicomponent m-health intervention, involving: weekly support messages to parents; physical resources; school nutrition guidelines and lunchbox lessons. SWAP IT has been reported to be effective. This study aims to determine the cost and cost effectiveness of the SWAP IT m-health intervention. The retrospective trial-based economic evaluation was conducted in 12 Catholic primary schools in New South Wales, Australia. Schools were randomised to intervention or usual care. The costs (AUD, 2019) were evaluated from societal perspectives. The direct cost to uptake the intervention and the incremental cost-effectiveness ratios (ICER) were calculated. ICERS were calculated for two outcomes: reduction in total kJ and reduction in discretionary kJ from the lunchbox. The total cost was calculated to be AUD 55, 467. The mean incremental cost per student to receive the intervention was calculated to be AUD 31/student. The cost per reduction in total lunchbox energy was AUD 0.54. The ICER for the reduction in energy from discretionary foods in the lunchbox was AUD 0.24. These findings suggest that this m-health intervention has potential to be cost effective in reducing the kilojoules from discretionary foods packed in school lunchboxes.

The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation

BackgroundDifferent approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants—CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon.MethodsA trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/NCT03520309), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children’s restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children’s oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon.DiscussionThe main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions.Trial registrationNCT03520309. Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

Exercise-based cardiac rehabilitation for coronary heart disease.

Exercise-based cardiac rehabilitation for coronary heart disease.

A trial-based economic evaluation of peppermint oil for the treatment of irritable bowel syndrome.

BackgroundIrritable Bowel Syndrome (IBS) is a prevalent, chronic gastrointestinal disorder that imposes a substantial socioeconomic burden. Peppermint oil is a frequently used treatment for IBS, but evidence about cost‐effectiveness is lacking.ObjectiveWe aimed to assess cost‐effectiveness of small‐intestinal release peppermint oil versus placebo in IBS patients.MethodsIn a multicenter randomized placebo‐controlled trial, cost‐effectiveness was evaluated from a societal perspective. The incremental cost‐effectiveness ratios (ICERs) were expressed as (1) incremental costs per Quality Adjusted Life Years (QALY), and (2) incremental costs per successfully treated patient, that is per abdominal pain responder (according to FDA definitions), both after an eight‐week treatment period with placebo versus peppermint oil. Cost‐utility and uncertainty were estimated using non‐parametric bootstrapping. Sensitivity analyses were performed.ResultsThe analysis comprised 126 patients (N = 64 placebo, N = 62 small‐intestinal release peppermint oil). Peppermint oil was a dominant treatment compared to placebo in 46% of bootstrap replications. Peppermint oil was also more effective but at higher cost in 31% of replications. The net‐benefit acceptability curve showed that peppermint oil has a 56% probability of being cost‐effective at a conservative willingness‐to‐pay threshold of €10.000/QALY. Peppermint oil was also a dominant treatment per additional successfully treated patient according to FDA definitions, that is in 51% of replications. In this case, the acceptability curve showed an 89% probability of being cost‐effective.ConclusionsIn patients with IBS, small‐intestinal release peppermint oil appears to be a cost‐effective treatment although there is uncertainty surrounding the ICER. When using abdominal pain responder as outcome measure for the ICER, peppermint oil has a high probability of being cost‐effective. The use of peppermint oil, which is a low‐cost treatment, can be justified by the modest QALY gains and slightly higher proportion of abdominal pain responders. More research and long‐term data are necessary to confirm the cost‐effectiveness of peppermint oil. NCT02716285.

Cost-Effectiveness of a School-and Family-Based Childhood Obesity Prevention Programme in China: The "CHIRPY DRAGON" Cluster-Randomised Controlled Trial.

Objectives: Rapid socioeconomic and nutrition transitions in Chinese populations have contributed to the growth in childhood obesity. This study presents a cost-effectiveness analysis of a school- and family-based childhood obesity prevention programme in China.Methods: A trial-based economic evaluation assessed cost-effectiveness at 12 months. Forty schools with 1,641 children were randomised to either receive the multi-component (diet and physical activity) intervention or to continue with usual activities. Both public sector and societal perspectives were adopted. Costs and benefits in the form of quality-adjusted life years (QALYs) were compared and uncertainty was assessed using established UK and US thresholds.Results: The intervention cost was 35.53 Yuan (£7.04/US$10.01) per child from a public sector perspective and 536.95 Yuan (£106/US$151) from a societal perspective. The incremental cost-effectiveness ratio (ICER) was 272.7 Yuan (£54/US$77)/BMI z-score change. The ICER was 8,888 Yuan (£1,760/US$2,502) and 73,831 Yuan (£14,620/US$20,796) per QALY from a public sector and societal perspective, respectively and was cost-effective using UK (£20,000) and US (US$50,000) per QALY thresholds.Conclusion: A multi-component school-based prevention programme is a cost-effective means of preventing childhood obesity in China.

Cost‐effectiveness of a mobile phone text messaging program (KIDNEYTEXT) targeting dietary behaviours in people receiving haemodialysis

There is little information available to inform the cost-effectiveness of eHealth interventions in improving patient health outcomes. A trial-based economic evaluation was undertaken aiming to inform the feasibility of conducting a mobile phone text messaging programme targeting dietary behaviours in people receiving haemodialysis. A trial-based economic evaluation from a health system perspective of a 6-month pilot randomised controlled trial was undertaken. One hundred and thirty patients receiving haemodialysis from six dialysis units across Sydney, Australia, were enrolled into the KIDNEYTEXT study. Usual care (inperson dietary counselling) was compared with usual care plus three semi-personalised dietary mobile phone text messages per week over a 6-month period. The outcomes of this economic evaluation included: cost of intervention, cost-effectiveness and marginal effects on total costs. The cost of developing and maintaining the KIDNEYTEXT intervention was US $110 per participant. Total costs were US $1418 higher in the usual care arm compared to the intervention arm. The incremental benefits for quality-adjusted life adjusted years were 0.01 [95% confidence interval (CI)=-0.03 to 0.06] and dietary adherence (i.e., adherent to three or more dietary guidelines at 6 months) being 0.04 (95% CI=-0.15 to 0.24). The largest component of total costs was related to unplanned admissions to hospital. Mobile phone text messages targeting dietary behaviours may be cost saving, at the same time as maintaining similar or improved dietary behaviours. A larger trial with a longer follow-up time is warranted.

A guide to caesarean wound healing

A guide to caesarean wound healing

Cost-Effectiveness of Peer-Educator-Delivered Lifestyle Modification for Type 2 Diabetes Prevention in a Young Healthy Population in Sri Lanka: A Trial-Based Economic Evaluation and Economic Model.

BackgroundThis study evaluated the cost effectiveness of an intensive lifestyle modification (LSM) intervention delivered by peer educators for the prevention of type 2 diabetes mellitus in a young at-risk population in a low healthcare resource setting.ObjectiveThe aim of this study was to evaluate the short-term and long-term cost effectiveness of an intensive lifestyle modification intervention for type 2 diabetes prevention in a young urban at-risk population in Sri Lanka.MethodsThis was an economic evaluation using cost and outcome data from a randomized controlled trial. We randomized 3539 healthy individuals aged 5–40 years with risk factors for type 2 diabetes to either 3-monthly (P-LSM n = 1727) or 12-monthly (C-LSM n = 1812) peer-educator advice aimed at reducing weight, improving diet, reducing psychological stress and increasing physical activity. A cost-effectiveness analysis was conducted from a health system perspective with outcomes expressed as disability-adjusted life-years (DALYs). Intervention costs and outcomes were collected during a median clinical trial period of 3 years and extrapolated to a lifetime horizon using economic modelling. Uncertainty in the lifetime model was explored by structural and probabilistic sensitivity analyses.ResultsThe costs of the more intensive peer support programme were partially offset by reduced costs of type 2 diabetes complications recorded over the trial period and completely offset by lifetime cost savings of 6000 LKR. The more intensive P-LSM also averted more DALYs, estimated at 0.456 DALYs over the lifetime of participants.ConclusionsIn a young at-risk Sri Lanka population, an intensive LSM programme was cost effective, averting more DALYs at an acceptable additional cost than a much less intensive LSM programme. Early intervention in young at-risk people represents good value for money from the Sri Lankan health care payer perspective.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-021-00284-5.

Joint Longitudinal Models for Dealing With Missing at Random Data in Trial-Based Economic Evaluations

ObjectivesIn trial-based economic evaluation, some individuals are typically associated with missing data at some time point, so that their corresponding aggregated outcomes (eg, quality-adjusted life-years) cannot be evaluated. Restricting the analysis to the complete cases is inefficient and can result in biased estimates, while imputation methods are often implemented under a missing at random (MAR) assumption. We propose the use of joint longitudinal models to extend standard approaches by taking into account the longitudinal structure to improve the estimation of the targeted quantities under MAR. MethodsWe compare the results from methods that handle missingness at an aggregated (case deletion, baseline imputation, and joint aggregated models) and disaggregated (joint longitudinal models) level under MAR. The methods are compared using a simulation study and applied to data from 2 real case studies. ResultsSimulations show that, according to which data affect the missingness process, aggregated methods may lead to biased results, while joint longitudinal models lead to valid inferences under MAR. The analysis of the 2 case studies support these results as both parameter estimates and cost-effectiveness results vary based on the amount of data incorporated into the model. ConclusionsOur analyses suggest that methods implemented at the aggregated level are potentially biased under MAR as they ignore the information from the partially observed follow-up data. This limitation can be overcome by extending the analysis to a longitudinal framework using joint models, which can incorporate all the available evidence.

Economic evaluation of a web-based menu planning intervention to improve childcare service adherence with dietary guidelines

BackgroundDespite the known benefits of healthy eating in childhood, few Australian childcare services provide food that is consistent with dietary guidelines. The effectiveness of a web-based menu planning intervention to increase childcare service provision of healthy foods and decrease provision of discretionary foods in long day-care services in Australia was assessed in a randomised controlled trial. Here we consider the costs, consequences, cost-effectiveness and budget impact of the intervention using data collected within the trial.MethodsThe prospective trial-based economic evaluation involved 54 childcare services across New South Wales (NSW), Australia. Services were randomised to a 12-month intervention or usual care. The intervention involved access to a web-based menu planning and decision support tool and online resources. Effectiveness measures included mean number of food groups, overall menu and individual food group compliance with dietary guidelines, and mean servings of food groups at 12 months. Costs (reported in $AUD, 2017/18) were evaluated from both health sector and societal perspectives. The direct cost to support uptake of the intervention was calculated, as were costs to each childcare service. The incremental cost of the intervention was calculated as the net difference in the cost to undertake menu planning and review plus the direct cost of the intervention. Incremental cost-effectiveness ratios (ICERs) including uncertainty intervals were estimated for differences in costs and effects between intervention and control groups. A relative value index was calculated to determine overall value for money.ResultsOver the 12 months of the trial, we calculated a difference in cost between usual practice and intervention groups of − $482 (95% UI − $859, − $56). While the measured increase in menu and food group compliance within the trial did not reach statistical significance, there were significant improvements in mean servings of fruit and discretionary food, represented in the cost-consequence analysis. The calculated relative value index of 1.1 suggests that the intervention returns acceptable value for money for the outcomes generated.ConclusionCompared to usual practice, web-based programmes may offer an efficient and sustainable alternative for childcare services to improve the provision of healthy foods to children in their care.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000974404

Protocol for an economic evaluation and budget impact assessment of a randomised, stepped-wedge controlled trial for practice change support to increase routine provision of antenatal care for maternal alcohol consumption

BackgroundAntenatal clinical practice guidelines recommend routine assessment of women’s alcohol consumption during pregnancy. The delivery of advice and referral when necessary are also recommended. However, evidence suggests there are barriers to the uptake of best-care guidelines. Effective, cost-effective and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised through addressing identified barriers. This paper describes the protocol for evaluating the efficiency and affordability of a practice change intervention compared to the usual practice in an implementation trial.MethodsThe effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting. An economic evaluation will be conducted alongside the trial to assess intervention efficiency. A budget impact assessment will be conducted to assess affordability. The prospective trial-based economic evaluation will identify, measure and value key resource and outcome impacts arising from the multi-strategy practice change intervention compared with usual practice. The evaluation will comprise (i) cost-consequence analyses, where a scorecard approach will be used to show the costs and benefits given the multiple primary outcomes included in the trial, and (ii) cost-effectiveness analyses, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for maternal alcohol consumption consistent with the guideline recommendations. Intervention affordability will be evaluated using budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fundholders. Results will be extrapolated to estimate the cost and cost-effectiveness of rolling out the model of care.DiscussionUptake of clinical guidelines requires practice change support. It is hypothesized that the implementation strategy, if found to be effective, will also be cost-effective, affordable and scalable. This protocol describes the economic evaluation that will address these hypotheses.Trial registrationAustralian and New Zealand Clinical Trials Registry, ACTRN12617000882325. Registered on 16 June 2017

An economic evaluation of tranexamic acid to prevent postpartum haemorrhage in women with vaginal delivery: the randomised controlled TRAAP trial.

To estimate the cost-effectiveness of tranexamic acid (TXA) use to prevent postpartum haemorrhage. A trial-based economic evaluation. Fifteen French university maternity hospitals. Women enrolled in the TRAAP randomised controlled trial comparing TXA versus placebo in women with vaginal delivery. TRAAP failed to show a reduction in postpartum haemorrhage of at least 500ml in the intervention arm but evidenced significant lower rates of secondary outcomes related to blood loss. We estimated direct medical costs from within-trial hospital resources collected prospectively from the study report form. All resources were costed at their value to the hospital. We estimated incremental cost per incremental haemorrhage averted. Among the 4079 women in the TRAAP trial, data necessary to calculate costs were available for 3836 (94.0%). The average total costs in the TXA and control groups were €2278±388 and €2288±409 per woman, respectively (P=0.79). In women with postpartum haemorrhage of at least 500ml (trial primary endpoint), costs were €2359±354 and €2409±525 (P=0.14); for provider-assessed clinically significant postpartum haemorrhage and postpartum haemorrhage of at least 1000ml, costs were respectively €2316±347 versus €2381±521 (P=0.22) and €2321±318 versus €2411±590 (P=0.35) in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% probability of saving costs and improving outcome. Our findings support the use of TXA, as both bleeding events and cost may be reduced three out of four times. Tranexamic acid at vaginal delivery reduces both costs and bleeding events 3 times out of 4.

Economic Evaluation of Factorial Trials: Cost-Utility Analysis of the Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes 2 × 2 × 2 Factorial Trial of Atorvastatin, Omega-3 Fish Oil, and Action Planning

ObjectivesWe applied principles for conducting economic evaluations of factorial trials to a trial-based economic evaluation of a cluster-randomized 2 × 2 × 2 factorial trial. We assessed the cost-effectiveness of atorvastatin, omega-3 fish oil, and an action-planning leaflet, alone and in combination, from a UK National Health Service perspective.MethodsThe Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes (AFORRD) Trial randomized 800 patients with type 2 diabetes to atorvastatin, omega-3, or their respective placebos and randomized general practices to receive a leaflet-based action-planning intervention designed to improve compliance or standard care. The trial was conducted at 59 UK general practices. Sixteen-week outcomes for each trial participant were extrapolated for 70 years using the United Kingdom Prospective Diabetes Study Outcomes Model v2.01. We analyzed the trial as a 2 × 2 factorial trial (ignoring interactions between action-planning leaflet and medication), as a 2 × 2 × 2 factorial trial (considering all interactions), and ignoring all interactions.ResultsWe observed several qualitative interactions for costs and quality-adjusted life-years (QALYs) that changed treatment rankings. However, different approaches to analyzing the factorial design did not change the conclusions. There was a ≥99% chance that atorvastatin is cost-effective and omega-3 is not, at a £20 000/QALY threshold.ConclusionsAtorvastatin monotherapy was the most cost-effective combination of the 3 trial interventions at a £20 000/QALY threshold. Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning. Recently-developed methods for analyzing factorial trials and combining parameter and sampling uncertainty were extended to estimate cost-effectiveness acceptability curves within a 2x2x2 factorial design with model-based extrapolation.

Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease

IntroductionIt is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with...

Towards community-based and recovery-oriented care for severe mental disorders in Southern and Eastern Europe: aims and design of a multi-country implementation and evaluation study (RECOVER-E)

BackgroundSubstantial strides have been made around the world in reforming mental health systems by shifting away from institutional care towards community-based services. Despite an extensive evidence base on what constitutes effective care for people with severe mental ill-health, many people in Europe do not have access to optimal mental health care. In an effort to consolidate previous efforts to improve community mental health care and support the complex transition from hospital-based to community-based care delivery, the RECOVER-E (LaRge-scalE implementation of COmmunity based mental health care for people with seVere and Enduring mental ill health in EuRopE) project aims to implement and evaluate multidisciplinary community mental health teams in five countries in Central and Eastern Europe. This paper provides a brief overview of the RECOVER-E project and its methods.MethodsFive implementation sites were selected (Sofia, Bulgaria; Zagreb, Croatia; Skopje, North Macedonia; Kotor, Montenegro; Siret-Suceava, Romania) where hospital-based mental health services are available (care as usual, CAU) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia). The intervention consists of the introduction of a new service delivery model in each site, consisting of community-based recovery-oriented care delivered by trained multidisciplinary community mental health teams (including a peer worker with lived experience of a severe mental disorder). The implementation outcomes of the teams and the effect of the team’s approach on patient and service utilisation outcomes will be evaluated using a mix of research methods. The study includes five planned hybrid implementation-effectiveness trials (1 per site) with patient-level randomization (n = 180, with patients randomised to either care as usual or intervention condition). Effectiveness is evaluated using a pragmatic non-blinded design with patients randomised into two parallel groups: receiving new community-based care or receiving usual care in the form of institutional, hospital-based mental health care. Trial-based health economic evaluation will be conducted; implementation outcomes will be evaluated, with data aligned with dimensions from the RE-AIM framework. Pathways to sustaining project results will be developed through policy dialogue sessions, which will be carried out in each country and through ongoing policy engagement activities at the European level.DiscussionThe RECOVER-E project has been developed and conducted to demonstrate the impact of implementing an evidence-based service delivery model for people with severe mental illness in different contexts in middle-income countries in Central and Eastern Europe. It is expected that the results will contribute to the growing evidence-base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition.Trial registration Each trial was registered before participant enrolment in the clinicaltrials.gov database: Site—Croatia, Zagreb (Trial Reg. No. NCT03862209); Montenegro, Kotor (Trial Reg. No. NCT03837340); Romania, Suceava (Trial Reg. No. NCT03884933); Macedonia, Skopje (Trial Reg. No. NCT03892473); Bulgaria, Sofia (Trial Reg. No. NCT03922425)

A trial-based economic evaluation of the Restore4Stroke self-management intervention compared to an education-based intervention for stroke patients and their partners

BackgroundSince stroke survivors are increasingly responsible for managing stroke-related changes in their own health and lifestyle, self-management skills are required. In a recent randomised controlled trial a self-management intervention based on proactive coping action planning (SMI) in comparison with an education-based intervention (EDU) in stroke patients was investigated. However, no relevant treatment effects on the Utrecht Proactive Coping Competence scale (UPCC) and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-Participation) were found. The current study is a trial-based economic evaluation from a societal perspective comparing the same interventions (SMI versus EDU).MethodsUPCC, USER-Participation and EuroQol (EQ-5D-3 L) and costs were measured at baseline, three, six and twelve months after treatment. For the cost-effectiveness analyses, incremental cost effectiveness ratios (ICERs) were calculated for UPCC and USER-Participation. For the cost-utility analyses the incremental cost utility ratio (ICUR) was expressed in cost per Quality Adjusted Life Years (QALYs). Outcomes were tested by means of AN(C)OVA analyses and costs differences by means of bootstrapping. Bootstrapping, sensitivity analyses and a subgroup analysis were performed to test the robustness of the findings.ResultsOne hundred thirteen stroke patients were included in this study. The mean differences in USER-Participation scores (95%CI:-13.08,-1.61, p-value = .013) were significant different between the two groups, this does not account for UPCC scores (95%CI:-.267, .113, p-value = not significant) and QALYs (p-value = not significant) at 12 months. The average total societal costs were not significantly different (95%CI:€-3380,€7099) for SMI (€17,333) in comparison with EDU (€15,520). Cost-effectiveness analyses showed a mean ICER of 26,514 for the UPCC and 346 for the USER-Participation. Cost-utility analysis resulted in an ICUR of €44,688 per QALY. Assuming a willingness to pay (WTP) threshold of €50,000 per QALY, the probability that SMI will be cost-effective is 52%. Sensitivity analyses and subgroup analysis showed the robustness of the results.ConclusionsSMI is probably not a cost-effective alternative in comparison with EDU. Based on the current results, the value of implementing SMI for a stroke population is debatable. We recommend further exploration of the potential cost-effectiveness of stroke-specific self-management interventions focusing on different underlying mechanisms and using different control treatments.