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Abstract Background Audit and Feedback (A&F) interventions based on quality indicators have been shown to lead to significant improvements in compliance with evidence-based care including de-adoption of low-value practices (LVPs). Our primary aim was to evaluate the cost-effectiveness of adding a hypothetical A&F module targeting LVPs for trauma admissions to an existing quality assurance intervention targeting high-value care and risk-adjusted outcomes. A secondary aim was to assess how certain A&F characteristics might influence its cost-effectiveness. Methods We conducted a cost-effectiveness analysis using a probabilistic static decision analytic model in the Québec trauma care continuum. We considered the Québec Ministry of Health perspective. Our economic evaluation compared a hypothetical scenario in which the A&F module targeting LVPs is implemented in a Canadian provincial trauma quality assurance program to a status quo scenario in which the A&F module is not implemented. In scenarios analyses we assessed the impact of A&F characteristics on its cost-effectiveness. Results are presented in terms of incremental costs per LVP avoided. Results Results suggest that the implementation of A&F module (Cost = $1,480,850; Number of LVPs = 6,005) is associated with higher costs and higher effectiveness compared to status quo (Cost = $1,124,661; Number of LVPs = 8,228). The A&F module would cost $160 per LVP avoided compared to status quo. The A&F module becomes more cost-effective with the addition of facilitation visits; more frequent evaluation; and when only high-volume trauma centers are considered. Conclusion A&F module targeting LVPs is associated with higher costs and higher effectiveness than status quo and has the potential to be cost-effective if the decision-makers’ willingness-to-pay is at least $160 per LVP avoided. This likely represents an underestimate of true ICER due to underestimated costs or missed opportunity costs. Results suggest that virtual facilitation visits, frequent evaluation, and implementing the module in high-volume centers can improve cost-effectiveness.

Abstract Background The current standard of care in the treatment of children with physical trauma presenting to non-designated pediatric trauma centers is consultation with a pediatric trauma center by telephone. This includes contacting a pediatric trauma specialist and transferring any child with a potentially serious injury to a regionalized level I pediatric trauma center. This approach to care frequently results in medically unnecessary transfers and may place undue burdens on families. A newer model of care, the “Virtual Pediatric Trauma Center” (VPTC), uses telemedicine to make the expertise of a level I pediatric trauma center virtually available to any hospital. While the use of the VPTC model of care is increasing, there have been no studies comparing the VPTC to standard care of injured children at non-designated trauma centers with respect to patient- and family-centered outcomes. The goal of this study is to compare the current standard of care to the VPTC with respect to family-centered outcomes developed by parents and community advisory boards. Methods We will use a stepped-wedge trial design to enroll children with physical trauma presenting to ten hospitals, including level II, level III, and non-designated trauma centers. The primary outcome measures are parent/family experience of care and distress 3 days following injury. Secondary aims include 30-day healthcare utilization, parent/family out-of-pocket costs at 3 days and 30 days after injury, transfer rates, and parent/family distress 30 days following injury. We expect at least 380 parents/families of children will be eligible for the study following an emergency department physician’s request for a level I pediatric trauma center consultation. We will evaluate parent/family experience of care and distress using previously validated instruments, healthcare utilization by family recollection and medical record abstraction, and out-of-pocket costs using standard economic analyses. Discussion We expect that the findings from this study will inform other level I pediatric trauma centers and non-pediatric trauma centers on how to improve their systems of care for injured children. The results will help to optimize communication, confidence, and shared decision-making between parents/families and clinical staff from both the transferring and receiving hospitals. Trial registration ClinicalTrials.gov Identifier: NCT04469036. Registered July 13, 2020 before start of inclusion.

Abstract Background Parenting programs can be economically attractive interventions for improving the mental health of both parents and their children. Few attempts have been made to analyse the value of children’s and parent’s outcomes simultaneously, to provide a qualified support for decision making. Methods A within trial cost-effectiveness evaluation was conducted, comparing Ladnaan, a culturally tailored parenting program for Somali-born parents, with a waitlist control. Quality-adjusted life years (QALY) for parents were estimated by mapping the General Health Questionnaire-12 to Euroqol’s EQ-5D-3L to retrieve utilities. Behavioural problems in children were measured using the Child Behaviour Checklist (CBCL). Intervention costs were estimated for the trial. A net benefit regression framework was employed to study the cost-effectiveness of the intervention, dealing with multiple effects in the same analysis to estimate different combinations of willingness-to pay (WTP) thresholds. Results For a WTP of roughly €300 for a one point improvement in total problems on the CBCL scale (children), Ladnaan is cost-effective. In contrast, the WTP would have to be roughly €580,000 per QALY (parents) for it to be cost-effective. Various combinations of WTP values for the two outcomes (i.e., CBCL and QALY) may be used to describe other scenarios where Ladnaan is cost-effective. Conclusions Decision-makers interested in multiple effects must take into account combinations of effects in relation to budget, in order to obtain cost-effective results. A culturally adapted parenting program may be cost-effective, depending on the primary outcome, or multiple outcomes of interest. Trial registration clinicaltrials.gov, NCT02114593. Registered 15 April 2014—prospectively registered, https://www.clinicaltrials.gov/ct2/results?recrs=&cond=&term=NCT02114593&cntry=&state=&city=&dist=

Abstract Background Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants’ care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. Methods In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. Results We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, − 4.44 to − 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups. Conclusions Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. Trial registration ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.

Abstract Background Economic evaluations commonly accompany trials of new treatments or interventions; however, regression methods and their corresponding advantages for the analysis of cost-effectiveness data are not widely appreciated. Methods To illustrate regression-based economic evaluation, we review a cost-effectiveness analysis conducted by the Canadian Cancer Trials Group’s Committee on Economic Analysis and implement net benefit regression. Results Net benefit regression offers a simple option for cost-effectiveness analyses of person-level data. By placing economic evaluation in a regression framework, regression-based techniques can facilitate the analysis and provide simple solutions to commonly encountered challenges (e.g., the need to adjust for potential confounders, identify key patient subgroups, and/or summarize “challenging” findings, like when a more effective regimen has the potential to be cost-saving). Conclusions Economic evaluations of patient-level data (e.g., from a clinical trial) can use net benefit regression to facilitate analysis and enhance results.

Abstract Background High orphan drug prices have gained the attention of payers and policy makers. These prices may reflect the need to recoup the cost of drug development from a small patient pool. However, estimates of the cost of orphan drug development are sparse. Methods Using publicly available data, we estimated the differences in trial characteristics and clinical development costs with 100 orphan and 100 non-orphan drugs. Results We found that the out-of-pocket clinical costs per approved orphan drug to be $166 million and $291 million (2013 USD) per non-orphan drug. The capitalized clinical costs per approved orphan drug and non-orphan drug were estimated to be $291 million and $412 million respectively. When focusing on new molecular entities only, we found that the capitalized clinical cost per approved orphan drug was half that of a non-orphan drug. Conclusions More discussion is needed to better align on which cost components should be included in research and development costs for pharmaceuticals.

Abstract Background Although Dialectical Behaviour Therapy (DBT) is an evidence-based psychosocial treatment for borderline personality disorder (BPD), the demand for it exceeds available resources. The commonly researched 12-month version of DBT is lengthy; this can pose a barrier to its adoption in many health care settings. Further, there are no data on the optimal length of psychotherapy for BPD. The aim of this study is to examine the clinical and cost-effectiveness of 6 versus 12 months of DBT for chronically suicidal individuals with BPD. A second aim of this study is to determine which patients are as likely to benefit from shorter treatment as from longer treatment. Methods/Design Powered for non-inferiority testing, this two-site single-blind trial involves the random assignment of 240 patients diagnosed with BPD to 6 or 12 months of standard DBT. The primary outcome is the frequency of suicidal or non-suicidal self-injurious episodes. Secondary outcomes include healthcare utilization, psychiatric and emotional symptoms, general and social functioning, and health status. Cost-effectiveness outcomes will include the cost of providing each treatment as well as health care and societal costs (e.g., missed work days and lost productivity). Assessments are scheduled at pretreatment and at 3-month intervals until 24 months. Discussion This is the first study to directly examine the dose-effect of psychotherapy for chronically suicidal individuals diagnosed with BPD. Examining both clinical and cost effectiveness in 6 versus 12 months of DBT will produce answers to the question of how much treatment is good enough. Information from this study will help to guide decisions about the allocation of scarce treatment resources and recommendations about the benefits of briefer treatment. Trial registration NCT02387736. Registered February 20, 2015.

Abstract Background Falls among older adults can cause serious morbidity and pose economic burdens on society. Older age is a known risk factor for falls and age has been shown to influence the effectiveness of fall prevention programs. To our knowledge, no studies have explicitly investigated whether cost-effectiveness of a multifactorial fall prevention intervention (the intervention) is influenced by age. This economic evaluation explores: 1) the cost-effectiveness of a multifactorial fall prevention intervention compared to usual care for community-dwelling adults ≥ 75 years at risk of falling in Canada; and 2) the influence of age on the cost-effectiveness of the intervention. Methods Net benefit regression was used to examine the cost-effectiveness of the intervention with willingness-to-pay values ranging from $0–$50,000. Effects were measured as change in the number of falls, from baseline to 6-month follow-up. Costs were measured using a societal perspective. The cost-effectiveness analysis was conducted for both the total sample and by age subgroups (75–84 and 85+ years). Results For the total sample, the intervention was not economically attractive. However, the intervention was cost-effective at higher willingness-to-pay (WTP) (≥ $25,000) for adults 75–84 years and at lower WTP (< $5,000) for adults 85+ years. Conclusions The cost-effectiveness of the intervention depends on age and decision makers' WTP to prevent falls. Understanding the influence of age on the cost-effectiveness of an intervention may help to target resources to those who benefit most. Trial registration Retrospectively registered. Clinicaltrials.gov identifier: NCT00463658 (18 April 2007).

Abstract Background Widespread increases in caesarean section (CS) rates have sparked concerns about risks to mothers and infants and rising healthcare costs. A multicentre, two-arm, cluster-randomized trial in Quebec, Canada assessed whether an audit and feedback intervention targeting health professionals would reduce CS rates for pregnant women compared to usual care, and concluded that it reduced CS rates without adverse effects on maternal or neonatal health. The effect was statistically significant but clinically small. We assessed cost-effectiveness to inform scale-up decisions. Methods A prospective economic evaluation was undertaken using individual patient data from the Quality of Care, Obstetrics Risk Management, and Mode of Delivery (QUARISMA) trial (April 2008 to October 2011). Analyses took a healthcare payer perspective. The time horizon captured hospital-based costs and clinical events for mothers and neonates from labour onset to 3 months postpartum. Resource use was identified and measured from patient charts and valued using standardized government sources. We estimated the changes in CS rates and costs for the intervention group (versus controls) between the baseline and post-intervention periods. We examined heterogeneity between clinical subgroups of high-risk versus low-risk pregnancies and estimated the joint uncertainty in cost-effectiveness over 20,000 trial simulations. We decomposed costs to identify drivers of change. Results The intervention group experienced per-patient reductions of 0.005 CS (95% confidence interval (CI): −0.015 to 0.004, P = 0.09) and $180 (95% CI: −$277 to − $83, P