Development of a Canadian Guidance for Reporting Real-world Evidence for Regulatory and Health-Technology Assessment (HTA) Decision Making.

Real-world evidence (RWE) can complement and fill knowledge gaps from randomized controlled trials to assist in health-technology assessment (HTA) for regulatory decision-making. However, the generation of RWE is an intricate process with many sequential decision points, and different methods and approaches may impact the quality and reliability of evidence. Standardization and transparency in reporting these decisions is imperative to appraise RWE and incorporate it into HTA decision-making. A partnership between Canadian health system stakeholders, namely Health Canada and Canada's Drug Agency (formerly the Canadian Agency for Drugs and Technologies in Health (CADTH)), was established to develop a guidance for standardization of reporting of RWE for regulatory and HTA decision-making in Canada. In this article, we describe the methods to develop the Guidance for Reporting Real-World Evidence document and checklist for reporting RWE for regulatory and HTA decision-making in Canada. This guidance can be adapted for other jurisdictions and will have future extensions to incorporate emerging issues with RWE and HTA decision-making.

Improving Transparency of Decision Models Through the Application of Decision Analytic Models with Omitted Objects Displayed (DAMWOOD).

The coronavirus disease 2019 (COVID-19) pandemic has increased public awareness of the influence of epidemiological and economic decision models on public policy decisions. Alongside this is an increased scrutiny on the development, analysis, reporting and utilisation of decision models for public policy making. Therefore, it is important that model developers can clearly explain and justify to all stakeholders what is included and excluded from a model developed to support decision-making, to both improve transparency and trust in decision-making. Our aim is to provide tools for improving communication between modellers and decision-makers, leading to improved transparency in decision-making. To do so, we extend the recently described directed acyclic graphs with omitted objects displayed (DAGWOOD) approach from Haber et al. (Ann Epidemiol 68:64-71, 2022) to decision analytic models, giving the decision analytic models with omitted objects displayed (DAMWOOD) approach. DAMWOOD is a framework for the identification of objects omitted from a decision model, as well as for consideration of the effects of omissions on model outcomes. Objects omitted from a decision model are classed as either an exclusion (known and unknown confounders), misdirection (alternative model pathways) or structure (e.g. model type, methods for estimating relationships between objects). DAMWOOD requires model developers to use explicit statements and provide illustration of included and omitted objects, supporting communication with model users and stakeholders, allowing them to provide input and feedback to modellers about which objects to include or omit in a model. In developing DAMWOOD, we considered two challenges we encountered in modelling for pandemic policy response. First, the scope of the decision problem is not always made sufficiently explicit by decision-makers, requiring modellers to intuit which policy options should be considered, and/or which outcomes should be considered in their evaluation. Second, there is rarely sufficient transparency to ensure stakeholders can see what is included in models and why. This limits stakeholders' ability to advocate to decision-makers for the prioritisation of specific outcomes and challenge the model results. To illustrate the application of DAMWOOD, we apply it to a previously published COVID-19 vaccine allocation optimisation model. The DAMWOOD diagrams illustrate the ways in which it is possible to improve the communication of model assumptions. The diagrams make explicit which outcomes are omitted and provide information on the expected impact of the omissions on model results. We discuss the usefulness of DAMWOOD for framing the decision problem, communicating the model structure and results and engaging with those making and affected by the decisions the model is developed to inform.

eMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol.

BACKGROUND: Symptoms of depression and anxiety are prevalent among adults with chronic health conditions, contributing to reduced quality of life, morbidity, and mortality. Mind-body wellness interventions (i.e. psychology programming, mindful movement, breathwork, meditation) may impact mental health symptoms, with online delivery offering access and scalability. Whether online mind-body wellness interventions are effective in improving patient outcomes across a broad range of chronic conditions remains uncertain. METHODS: This three-armed, pragmatic, randomized controlled trial will use a nested mixed methods approach to assess the effectiveness of an online mind-body wellness intervention (eMPower), offered at two levels of personnel support, on symptoms of anxiety and depression in adults with chronic health conditions. Inclusion criteria require a self-reported chronic condition and access to an internet-connected device. Eligible participants will be randomized 1:1:1 to [1] waitlist control; [2] eMPower; [3] eMPower + weekly 1-to-1 check-in. The primary analysis will compare the Hospital and Anxiety Depression Scale (HADS) total score between eMPower + weekly 1-to-1 check-in versus controls, with secondary and exploratory outcomes including HADS subscales, health-related quality of life, fatigue, program engagement, and frailty. CONCLUSION: With online intervention delivery, a range of outcomes, mixed method evaluation, and automated intervention tracking, findings are anticipated to enhance our understanding of how individuals living with chronic health conditions engage with and are impacted by online mind-body wellness programming. Six hundred and fifty-six participants have been enrolled as of April 5, 2024, and 598 patients have completed 12-week follow-up.

Utilization of early supported discharge and outpatient rehabilitation services following inpatient stroke rehabilitation.

BACKGROUND: Studies examining factors associated with patient referral to early supported discharge (ESD)/outpatient rehabilitation (OPR) programs and utilization of ESD/OPR services after discharge from inpatient stroke rehabilitation (IPR) are scarce. Accordingly, we examined utilization of ESD/OPR services following discharge from IPR and patient factors associated with service utilization. METHODS: Stroke patients discharged from IPR facilities in Alberta between April 2014 and March 2016 were included and followed for one year for ESD/OPR service utilization. Multivariable linear and negative binomial regressions were used to examine association of patients' factors with ESD/OPR use. RESULTS: We included 752 patients (34.4% of 2,187 patients discharged from IPR) who had 40,772 ESD/OPR visits during one year of follow-up in the analysis. Mean and median ESD/OPR visits were 54.2 and 36 visits, respectively. Unadjusted ESD/OPR visits were lower in females and patients aged ≥ 60 years but were similar between urban and rural areas. After adjustment for patient factors, patients in urban areas and discharged home after IPR were associated with 83.5% and 61.9%, respectively, increase in ESD/OPR visits, while having a right-body stroke was associated with 23.5% increase. Older patients used ESD/OPR less than their younger counterparts (1.4% decrease per one year of older age). Available factors explained 12.3% of variation in ESD/OPR use. CONCLUSION: ESD/OPR utilization after IPR in Alberta was low and varied across age and geographic locations. Factors associated with use of ESD/OPR were identified but they could not fully explain variation of ESD/OPR use.

Capturing Valuation Study Sampling Uncertainty in the Estimation of Health State Utility Values Using the EQ-5D-3L.

OBJECTIVES: Utility scores associated with preference-based health-related quality-of-life instruments such as the EQ-5D-3L are reported as point estimates. In this study, we develop methods for capturing the uncertainty associated with the valuation study of the UK EQ-5D-3L that arises from the variability inherent in the underlying data, which is tacitly ignored by point estimates. We derive a new tariff that properly accounts for this and assigns a specific closed-form distribution to the utility of each of the 243 health states of the EQ-5D-3L. METHODS: Using the UK EQ-5D-3L valuation study, we used a Bayesian approach to obtain the posterior distributions of the derived utility scores. We constructed a hierarchical model that accounts for model misspecification and the responses of the survey participants to obtain Markov chain Monte Carlo (MCMC) samples from the posteriors. The posterior distributions were approximated by mixtures of normal distributions under the Kullback-Leibler (KL) divergence as the criterion for the assessment of the approximation. We considered the Broyden-Fletcher-Goldfarb-Shanno (BFGS) algorithm to estimate the parameters of the mixture distributions. RESULTS: We derived an MCMC sample of total size 4,000 × 243. No evidence of nonconvergence was found. Our model was robust to changes in priors and starting values. The posterior utility distributions of the EQ-5D-3L states were summarized as 3-component mixtures of normal distributions, and the corresponding KL divergence values were low. CONCLUSIONS: Our method accounts for layers of uncertainty in valuation studies, which are otherwise ignored. Our techniques can be applied to other instruments and countries' populations. HIGHLIGHTS: Guidelines for health technology assessments typically require that uncertainty be accounted for in economic evaluations, but the parameter uncertainty of the regression model used in the valuation study of the health instrument is often tacitly ignored.We consider the UK valuation study of the EQ-5D-3L and construct a Bayesian model that accounts for layers of uncertainty that would otherwise be disregarded, and we derive closed-form utility distributions.The derived tariff can be used by researchers in economic evaluations, as it allows analysts to directly sample a utility value from its corresponding distribution, which reflects the associated uncertainty of the utility score.

Bone-anchored prostheses for transfemoral amputation: a systematic review of outcomes, complications, patient experiences, and cost-effectiveness.

Introduction: Bone-anchored prostheses (BAP) are an advanced reconstructive surgical approach for individuals who had transfemoral amputation and are unable to use the conventional socket-suspension systems for their prostheses. Access to this technology has been limited in part due to the lag between the start of a new procedure and the availability of evidence that is required before making decisions about widespread provision. This systematic review presents as a single resource up-to-date information on aspects most relevant to decision makers, i.e., clinical efficacy, safety parameters, patient experiences, and health economic outcomes of this technology. Methods: A systematic search of the literature was conducted by an information specialist in PubMed, MEDLINE, Embase, CINAHL, Cochrane Library, the Core Collection of Web of Science, CADTH's Grey Matters, and Google Scholar up until May 31, 2023. Peer-reviewed original research articles on the outcomes of clinical effectiveness (health-related quality of life, mobility, and prosthesis usage), complications and adverse events, patient experiences, and health economic outcomes were included. The quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence and ROBINS-I, as appropriate. Results: Fifty studies met the inclusion criteria, of which 12 were excluded. Thirty-eight studies were finally included in this review, of which 21 reported on clinical outcomes and complications, 9 case series and 1 cohort study focused specifically on complications and adverse events, and 2 and 5 qualitative studies reported on patient experience and health economic assessments, respectively. The most common study design is a single-arm trial (pre-/post-intervention design) with varying lengths of follow-up. Discussion: The clinical efficacy of this technology is evident in selected populations. Overall, patients reported increased health-related quality of life, mobility, and prosthesis usage post-intervention. The most common complication is a superficial or soft-tissue infection, and more serious complications are rare. Patient-reported experiences have generally been positive. Evidence indicates that bone-anchored implants for prosthesis fixation are cost-effective for those individuals who face significant challenges in using socket-suspension systems, although they may offer no additional advantage to those who are functioning well with their socket-suspended prostheses.

Clinical and Socioeconomic Associations With Hospital Days and Emergency Department Visits Among Medically Complex Children: A Retrospective Cohort Study.

OBJECTIVES: To estimate associations between clinical and socioeconomic variables and hospital days and emergency department (ED) visits for children with medical complexity (CMCs) for 5 years after index admission. METHODS: Retrospective, longitudinal, population-based cohort study of CMCs in Alberta (n = 12 621) diagnosed between 2010 and 2013 using administrative data linked to socioeconomic data. The primary outcomes were annual cumulative numbers of hospital days and ED visits for 5 years after index admission. Data were analyzed using mixed-effect hurdle regression. RESULTS: Among CMCs utilizing resources, those with more chronic medications had more hospital days (relative difference [RD] 3.331 for ≥5 vs 0 medications in year 1, SE 0.347, P value < .001) and ED visits (RD 1.836 for 0 vs ≥5 medications in year 1, SE 0.133, P value < .001). Among these CMCs, initial length of stay had significant, positive associations with hospital days (RD 1.960-5.097, SE 0.161-0.610, P value < .001 outside of the gastrointestinal and hematology and immunodeficiency groups). Those residing in rural or remote areas had more ED visits than those in urban or metropolitan locations (RD 1.727 for rural versus urban, SE 0.075, P < .001). Material and social deprivation had significant, positive associations with number of ED visits. CONCLUSIONS: Clinical factors are more strongly associated with hospitalizations and socioeconomic factors with ED visits. Policy administrators and researchers aiming to optimize resource use and improve outcomes for CMCs should consider interventions that include both clinical care and socioeconomic support.

Logical Inconsistencies in the Health Years in Total and Equal Value of Life-Years Gained.

OBJECTIVES: This study aimed to assess whether recently proposed alternatives to the quality-adjusted life-year (QALY), intended to address concerns about discrimination, are suitable for informing resource allocation decisions. METHODS: We consider 2 alternatives to the QALY: the health years in total (HYT), recently proposed by Basu et al, and the equal value of life-years gained (evLYG), currently used by the Institute for Clinical and Economic Review. For completeness we also consider unweighted life-years (LYs). Using a hypothetical example comparing 3 mutually exclusive treatment options, we consider how calculations are performed under each approach and whether the resulting rankings are logically consistent. We also explore some further challenges that arise from the unique properties of the HYT approach. RESULTS: The HYT and evLYG approaches can result in logical inconsistencies that do not arise under the QALY or LY approaches. HYT can violate the independence of irrelevant alternatives axiom, whereas the evLYG can produce an unstable ranking of treatment options. HYT have additional issues, including an implausible assumption that the utilities associated with health-related quality of life and LYs are "separable," and a consideration of "counterfactual" health-related quality of life for patients who are dead. CONCLUSIONS: The HYT and evLYG approaches can result in logically inconsistent decisions. We recommend that decision makers avoid these approaches and that the logical consistency of any approaches proposed in future be thoroughly explored before considering their use in practice.

Generic Health Utility Measures in Exercise Oncology: A Scoping Review and Future Directions.

Despite the evidence that exercise is effective at mitigating common side effects in adults with cancer, it is rarely part of usual cancer care. One reason for this is the lack of economic evidence supporting the benefit of exercise. Economic evaluations often rely on the use of generic utility measures to assess cost effectiveness. This review identifies and synthesizes the literature on the use of generic utility measures used to evaluate exercise interventions for adults with cancer. A systematic search of the literature from January 2000 to February 2023 was conducted using four databases (Medline, EMBASE, CINAHL, Academic Search Complete). Exercise studies involving adults with any type of cancer that used a generic utility measure were eligible for inclusion. Of the 2780 citations retrieved, 10 articles were included in this review. Seven articles included economic evaluations, with varying results. Four studies reported on cost-effectiveness; however, detailed effectiveness data derived from the generic utility measure were often not reported. Generic utility measures help to compare baseline values of and changes in health utility weights across studies and to general population norms; however, to date, they are underutilized in exercise oncology studies. Consideration should be given to the identified research evidence, population, and methodological gaps.

A systematic review of the accessibility, acceptability, safety, efficiency, clinical effectiveness, and cost-effectiveness of private cataract and orthopedic surgery clinics.

OBJECTIVES: Many publicly funded health systems use a mix of privately and publicly operated providers of care to deliver elective surgical services. The aim of this systematic review was to assess the role of privately operated but publicly funded provision of surgical services for adult patients who had cataract or orthopedic surgery within publicly funded health systems in high-income countries. METHODS: Electronic databases (Ovid MEDLINE, OVID Embase, and EBSCO EconLit) were searched on 26 March 2021, and gray literature sources were searched on 6 April 2021. Two reviewers independently applied inclusion and exclusion criteria to identify studies, and extracted data. The outcomes evaluated include accessibility, acceptability, safety, clinical effectiveness, efficiency, and cost/cost-effectiveness. RESULTS: Twenty-nine primary studies met the inclusion criteria and were synthesized narratively. We found mixed results across each of our reported outcomes. Wait times were shorter for patients treated in private facilities. There was evidence that some private facilities cherry-pick or cream-skim by selecting less complex patients, which increases the postoperative length of stay and costs for public facilities, restricts access to private facilities for certain groups of patients, and increases inequality within the health system. Seven studies found improved safety outcomes in private facilities, noting that private patients had a lower preoperative risk of complications. Only two studies reported cost and cost-effectiveness outcomes. One costing study concluded that private facilities' costs were lower than those of public facilities, and a cost-utility study showed that private contracting to reduce public waiting times for joint replacement was cost-effective. CONCLUSIONS: Limited evidence exists that private-sector contracts address existing healthcare delivery problems. Value for money also remains to be evaluated properly.

Cost Analysis of a Transition Care Bundle Compared with Usual Care for COPD Patients Being Discharged from Hospital: Evaluation of a Randomized Controlled Trial.

BACKGROUND: Appropriate management of chronic obstructive pulmonary disease (COPD) patients following acute exacerbations can reduce the risk of future exacerbations, improve health status, and lower care costs. While a transition care bundle (TCB) was associated with lower readmissions to hospitals than usual care (UC), it remains unclear whether the TCB was associated with cost savings. OBJECTIVE: The aim of this study was to evaluate how this TCB was associated with future Emergency Department (ED)/outpatient visits, hospital readmissions, and costs in Alberta, Canada. METHODS: Patients who were aged 35 years or older, who were admitted to hospital for a COPD exacerbation, and had not been treated with a care bundle received either TCB or UC. Those who received the TCB were then randomized to either TCB alone or TCB enhanced with a care coordinator. Data collected were ED/outpatient visits, hospital admissions and associated resources used for index admissions, and 7-, 30- and 90-day post-index discharge. A decision model with a 90-day time horizon was developed to estimate the cost. A generalized linear regression was conducted to adjust for imbalance in patient characteristics and comorbidities, and a sensitivity analysis was conducted on the proportion of patients' combined ED/outpatient visits and inpatient admissions as well as the use of a care coordinator. RESULTS: Differences in length of stay (LOS) and costs between groups were statistically significant, although with some exceptions. Inpatient LOS and costs were 7.1 days (95% confidence interval [CI] 6.9-7.3) and Canadian dollars (CAN$) 13,131 (95% CI CAN$12,969-CAN$13,294) in UC, 6.1 days (95% CI 5.8-6.5) and CAN$7634 (95% CI CAN$7546-CAN$7722) in TCB with a coordinator, and 5.9 days (95% CI 5.6-6.2) and CAN$8080 (95% CI CAN$7975-CAN$8184) in TCB without a coordinator. Decision modelling indicated TCB was less costly than UC, with a mean (standard deviation [SD]) of CAN$10,172 (40) versus CAN$15,588 (85), and TCB with a coordinator was slightly less costly than without a coordinator (CAN$10,109 [49] versus CAN$10,244 [57]). CONCLUSION: This study suggests that the use of the TCB, with or without a care coordinator, appears to be an economically attractive intervention compared with UC.

Length of Stay and Home Discharge for Patients with Inpatient Stroke Rehabilitation.

OBJECTIVE: To examine temporal trends and geographic variations and predict inpatient rehabilitation (IPR) length of stay (LOS) and home discharge for stroke patients. METHODS: Patients aged ≥18 years who were admitted to an IPR facility in Alberta, Canada, between 04/2014 and 03/2018 (years 2014-2017) were included. Predictors of LOS and home discharge were examined using 2014-2016 data and validated using 2017 data. Multivariable linear regression (MLR), multivariable negative binomial (MNB), and multivariable quantile regressions (MQR) were used to examine LOS, and logistic regression was used for home discharge. RESULTS: We included 2686 rehabilitation admissions between 2014 and 2017. The mean LOS decreased (2014: 71 days; 2017: 62.1 days; p = 0.003) during the study period and was shortest in Edmonton (59.1 days) compared to Calgary (66 days) or other localities (70.8 days; p < 0.001). Three-quarters of patients were discharged home and this proportion remained unchanged between 2014 and 2017. Calgary patients were more likely to be discharged home than those in Edmonton (OR = 0.62; p = 0.019) or other localities (OR = 0.39; p = 0.011). The MLR and MNB models provided accurate prediction for the mean LOS (predicted = 59.9 and 60.8 days, respectively, vs. actual = 62.1 days; both p > 0.5), while the MQR model did so for the median LOS (predicted = 44.3 days vs. actual = 44 days; p = 0.09). The logistic regression resulted in 82.4% of correct prediction, a sensitivity of 91.6%, and a specificity of 50.7% for home discharge. CONCLUSIONS: Rehabilitation LOS decreased while the proportion of home discharge remained unchanged during the study period. Both varied across health zones. Identifiable statistical models provided accurate prediction with a separate patient cohort.

Optimal Planning of Health Services through Genetic Algorithm and Discrete Event Simulation: A Proposed Model and Its Application to Stroke Rehabilitation Care.

Background. Increasing demand for provision of care to stroke survivors creates challenges for health care planners. A key concern is the optimal alignment of health care resources between provision of acute care, rehabilitation, and among different segments of rehabilitation, including inpatient rehabilitation, early supported discharge (ESD), and outpatient rehabilitation (OPR). We propose a novel application of discrete event simulation (DES) combined with a genetic algorithm (GA) to identify the optimal configuration of rehabilitation that maximizes patient benefits subject to finite health care resources. Design. Our stroke rehabilitation optimal model (sROM) combines DES and GA to identify an optimal solution that minimizes wait time for each segment of rehabilitation by changing care capacity across different segments. sROM is initiated by generating parameters for DES. GA is used to evaluate wait time from DES. If wait time meets specified stopping criteria, the search process stops at a point at which optimal capacity is reached. If not, capacity estimates are updated, and an additional iteration of the DES is run. To parameterize the model, we standardized real-world data from medical records by fitting them into probability distributions. A meta-analysis was conducted to determine the likelihood of stroke survivors flowing across rehabilitation segments. Results. We predict that rehabilitation planners in Alberta, Canada, have the potential to improve services by increasing capacity from 75 to 113 patients per day for ESD and from 101 to 143 patients per day for OPR. Compared with the status quo, optimal capacity would provide ESD to 138 (s = 29.5) more survivors and OPR to 262 (s = 45.5) more annually while having an estimated net annual cost savings of $25.45 (s = 15.02) million. Conclusions. The combination of DES and GA can be used to estimate optimal service capacity. Highlights: We created a hybrid model combining a genetic algorithm and discrete event simulation to search for the optimal configuration of health care service capacity that maximizes patient outcomes subject to finite health system resources.We applied a probability distribution fitting process to standardize real-world data to probability distributions. The process consists of choosing the distribution type and estimating the parameters of that distribution that best reflects the data. Standardizing real-word data to a best-fitted distribution can increase model generalizability.In an illustrative study of stroke rehabilitation care, resource allocation to stroke rehabilitation services under an optimal configuration allows provision of care to more stroke survivors who need services while reducing wait time.Resources needed to expand rehabilitation services could be reallocated from the savings due to reduced wait time in acute care units. In general, the predicted optimal configuration of stroke rehabilitation services is associated with a net cost savings to the health care system.

A Conceptual Framework for Life-Cycle Health Technology Assessment.

OBJECTIVES: Health technology assessment (HTA) uses evidence appraisal and synthesis with economic evaluation to inform adoption decisions. Standard HTA processes sometimes struggle to (1) support decisions that involve significant uncertainty and (2) encourage continued generation of and adaptation to new evidence. We propose the life-cycle (LC)-HTA framework, addressing these challenges by providing additional tools to decision makers and improving outcomes for all stakeholders. METHODS: Under the LC-HTA framework, HTA processes align to LC management. LC-HTA introduces changes in HTA methods to minimize analytic time while optimizing decision certainty. Where decision uncertainty exists, we recommend risk-based pricing and research-oriented managed access (ROMA). Contractual procurement agreements define the terms of reassessment and provide additional decision options to HTA agencies. LC-HTA extends value-of-information methods to inform ROMA agreements, leveraging routine, administrative data, and registries to reduce uncertainty. RESULTS: LC-HTA enables the adoption of high-value high-risk innovations while improving health system sustainability through risk-sharing and reducing uncertainty. Responsiveness to evolving evidence is improved through contractually embedded decision rules to simplify reassessment. ROMA allows conditional adoption to obtain additional information, with confidence that the net value of that adoption decision is positive. CONCLUSIONS: The LC-HTA framework improves outcomes for patients, sponsors, and payers. Patients benefit through earlier access to new technologies. Payers increase the value of the technologies they invest in and gain mechanisms to review investments. Sponsors benefit through greater certainty in outcomes related to their investment, swifter access to markets, and greater opportunities to demonstrate value.

An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial.

Over the past decade, visits to American and Canadian emergency departments (EDs) for child and youth mental health care have increased substantially.1,2 Acute mental health crises can occur as a result of a variety of concerns, including those that are life threatening (eg, suicide attempts), pose safety concerns (eg, suicidal intentions, aggressive behaviors, alcohol and other drug use), and are physically distressing to the child or youth (eg, panic attacks). ED health care providers play a vital role in assessing the safety and well-being of the child or youth and referring them to services for ongoing care.3,4 During the ED visit, assessment and care should pinpoint risks, inform treatment, and consider family needs and preferences as part of a patient-centered approach. Yet, this approach to care is not widely adopted in EDs. Most EDs do not require the use of pediatric-specific mental health tools to guide assessments or have patient-centered procedures in place to guide the care of patients with mental health emergencies.5-7 Our team believes these limitations have led to the provision of acute mental health care that can lack sufficient quality and efficiency. This study protocol describes a trial designed to evaluate if a novel mental health care bundle that was co-designed with parents and youth results in greater improvements in the well-being of children and youth 30 days after seeking ED care for mental health and/or substance misuse concerns compared with existing care protocols. We hypothesize that the bundle will positively impact child and youth well-being, while also providing cost-effective health care system benefits.

Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease.

Background App-based strategies are a promising solution to deliver nutrition and exercise interventions during social distancing. With limited RCT data in individuals with chronic disease, further information is required both to determine impact, and to guide delivery. The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease. As compared to controls receiving educational material, the aim of this study is to assess the acceptability, effectiveness, and cost of Heal-Me app programming delivered alongside two levels of dietitian and exercise-specialist support. Methods Heal-Me PiONEer is a 12-week, 3-arm RCT with randomization to one of three study groups (n=72 per group, 216 total). Group 1 (control: educational material), Group 2 (Heal-Me app + virtual group dietitian/exercise-specialist sessions), Group 3 (Heal-Me app + virtual group and 1-to-1 dietitian/exercise-specialist sessions). Inclusion criteria: adults with cancer, chronic lung disease or status post-transplantation from liver or lung transplant; previous completion of an exercise rehabilitation program; access to an internet-connected device. Study outcomes measured at study weeks 0 and 12 include: Primary - Lower Extremity Functional Scale; Secondary - virtual physical function tests, loneliness, resilience, anxiety, well-being and health-related quality of life; Exploratory outcomes - protein intake, behavioral beliefs around exercise and nutrition, adherence, adverse events, acceptability, and cost-utility. Conclusions The Heal-Me PiONEer RCT holds promise to provide a comprehensive understanding of the delivery and impact of app-based nutrition and exercise programming in a diverse group of participants with chronic disease.

The diagonal approach: A theoretic framework for the economic evaluation of vertical and horizontal interventions in healthcare.

The diagonal approach is a health system funding concept wherein vertical approaches targeting specific diseases are combined with horizontal approaches intended to strengthen health systems broadly. This taxonomy can also be used to classify health system interventions as either vertical or horizontal. Previous studies have used mathematical programming to evaluate horizontal interventions, but these models have not allowed concurrent evaluation of different types of horizontal interventions or captured spillovers and intertemporal effects. This paper aims to develop a theoretic framework for the diagonal approach. The framework is articulated through integer programming, maximizing health benefits given constraints by identifying the optimal set of both vertical and horizontal interventions to fund. The theoretic framework for the diagonal approach is developed by synthesizing and expanding three prior works. The decision problem is synthesised to allow concurrent evaluation of three different types of horizontal interventions, those: (i) improving health system efficiency, (ii) improving capacity, and (iii) investing in new platforms. Linear programs are converted to integer form, relaxing previous assumptions related to constant returns to scale and divisibility of interventions. The framework is expanded to evaluate multiple budget constraints and options for new platforms. A new form for the value function is used to estimate the benefits of intervention combinations, capturing spillovers between vertical and horizontal interventions and dynamic returns to scale. The decision problem is specified inferotemporally, explicitly capturing the impact of the time horizon on the optimal choice set. Dynamic examples are provided to demonstrate the advantages of the diagonal approach over prior frameworks. This framework extends existing works, enabling simultaneous comparison of various combinations of both vertical and horizontal interventions, capturing spillovers and intertemporal effects. The diagonal approach framework defines decision problems flexibly and realistically, forming the basis for future applied work. Implementation would improve resource allocation and patient health outcomes.

An observational cohort study of health outcomes and costs associated with early pregnancy assessment units in the UK.

BACKGROUND: The objective of this study was to assess the impact of consultant presence, volume of patients seen and weekend opening on the health and cost-related outcomes associated with different Early Pregnancy Assessment Unit (EPAU) configurations. METHODS: This was an observational study with a prospective cohort design. Six thousand six hundred six pregnant women (16 years of age and over) attending EPAUs because of suspected early pregnancy complications were recruited from 44 EPAUs across the UK. The main outcome measures were quality of life, costs, and anxiety. RESULTS: Costs, quality of life and anxiety scores were similar across configurations with little evidence to suggest an impact of consultant presence, weekend opening or volume of patients seen. Mean overall costs varied from £92 (95% CI £85 - £98) for a diagnosis of normally developing pregnancy to £1793 (95% CI £1346 - £2240) for a molar pregnancy. EQ-5D-5L score increased from 0.85 (95% CI 0.84-0.86) at baseline to 0.91 (95% CI 0.90-0.92) at 4 weeks for the 573 women who completed questionnaires at both time points, largely due to improvements in the pain/discomfort and anxiety/depression dimensions. 78% of women reported a decrease in their anxiety score immediately following their EPAU appointment. CONCLUSIONS: EPAU configuration, as specified in this study, had limited impact on any of the outcomes examined. However, it is clear that care provided in the EPAU has a positive overall effect on women's health and emotional wellbeing, with significant improvements in EQ-5D and anxiety shown following an EPAU visit.