Background:Polypharmacy is a major challenge for patient safety and effective resource use. High-quality evidence supporting polypharmacy management is lacking. Aim:To develop, optimise and evaluate a primary care complex intervention for reducing medically defined potentially inappropriate prescribing among patients experiencing polypharmacy. Methods:Phase 1: Qualitative interviews and focus groups with patients and professionals explored views/experiences of existing National Health Service Scotland interventions, informing development of core intervention components. Phase 2: An external pilot-feasibility study was conducted in five general practitioner practices to optimise the Improving Medicines use in People with Polypharmacy in Primary care intervention. A formative mixed-methods process evaluation examined intervention implementation, alongside evaluating trial processes and collecting data to inform phase 3. Phase 3: A pragmatic, open-label two-arm parallel cluster-randomised trial was conducted in English general practice. The intervention (19 practices) comprised a structured, collaborative and patient-centred approach to medication review, supported by informatics, clinician training, performance feedback and financial incentivisation. The comparator was usual care (18 practices). Up to 50 adults receiving ≥ 5 regular medications, with ≥ 1 indicator of potentially inappropriate prescribing, were reviewed per practice over 6 months. Primary outcome was number of potentially inappropriate prescribing indicators at 26-week follow-up. Secondary outcomes included patient-reported measures and service use. Cost-effectiveness and cost-utility analyses were conducted (primary economic outcome quality-adjusted life-years). A mixed-methods process evaluation (patient surveys, patient/clinician interviews, audio-recorded observations) explored implementation. Results:Phase 1: Intervention component design was informed by findings related to elements of the medication review, informatics and clinician training. Phase 2: Core intervention elements were successfully implemented in the pilot, although clinical delivery was hampered by disruptions due to the coronavirus disease pandemic. Phase 3: Participants were recruited between January and June 2022 (intervention N = 891, usual care N = 836), median age 73 years, 49% female, with median four long-term conditions and eight medications. No improvement in the primary outcome was observed (mean difference potentially inappropriate prescribing count - 0.007; 95% confidence interval -0.21 to 0.199). Treatment burden was slightly improved, and subgroup analysis suggested potential improvements in less complex patients. The process evaluation found general practitioners and pharmacists valued and benefitted from the model of interprofessional collaboration, which strengthened working relationships and provided an opportunity for knowledge sharing and joint decision-making that supported management of clinical uncertainty. Most patients (73.2%) reported satisfaction with the review, with satisfaction strongly associated with perceptions of shared decision-making. There was no evidence of cost-effectiveness, although the economic evaluation did not quantify the aforementioned benefits or other broader factors of potential interest to decision-makers. Limitations:Key limitations include concurrent changes in usual care, potentially insensitive outcome measures and limited study-population generalisability. Interpretation:A complex medication optimisation intervention did not reduce potentially inappropriate prescribing in patients with polypharmacy. Findings strongly support revisiting current medication optimisation policy, with one-off structured reviews, even when enhanced with digital healthcare solutions and clinical pharmacy investment, not guaranteed to improve key clinical outcomes. Nevertheless, the positive patient and clinician findings are important: protected time for interprofessional collaborative working, plus effective integration of shared decision-making within patient-facing reviews, may facilitate improved patient care more broadly. Future work:Research should develop new patient-centred outcomes and identify higher-risk patients. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number 16/118/14.

Introduction Medical advancements have led to increased survival for critically ill children, many of whom require tracheostomy. Standardised protocols in paediatric tracheostomy have been associated with reduced hospital length of stay, lower readmission rates and reduced acute healthcare costs, without compromising safety. DECIDE-T (Digital hEalth pathway for ChIldren with meDical complExity requiring Tracheostomy) is a novel initiative that moves beyond single-site quality-improvement efforts to deliver a provincially coordinated, multicentre digital care pathway integrated into the electronic health record system. The initiative spans the full care continuum—from decision-making and acute care to home transition and decannulation—with the goal of improving clinical outcomes, efficiency and caregiver experience. Methods and analysis DECIDE-T is a multicentre single-arm pre–post implementation study that applies multiple theory-based frameworks for implementation and evaluation. It incorporates both quantitative and qualitative research methods to assess the implementation and impact of the intervention. Guided by the Quality Implementation Framework and the Interactive Systems Framework, the study includes four phases: (1) Site assessments to identify implementation barriers and facilitators using the Consolidated Framework for Implementation Research (CFIR); (2) Developing a comprehensive plan and implementation strategies using the CFIR-Expert Recommendations for Implementing Change Matching Tool; (3) Pathway roll-out and evaluation of clinical, process and economic outcomes guided by the RE-AIM framework (reach, effectiveness, adoption, implementation and maintenance); and (4) Dissemination of lessons learnt from the implementation experience. Data collection will involve surveys, interviews, focus groups, care pathway audits, patients’ clinical and administrative data, analysed using thematic content analysis and interrupted time series analysis. The economic evaluation will be conducted from the perspective of the public healthcare system through a net-monetary benefit analysis. Ethics and dissemination The study was reviewed and approved by the University of Alberta Health Research Ethics Board. The results will be disseminated to DECIDE-T care pathway end users, partners and collaborators. Dissemination will occur through public engagement forums, webinars, peer-reviewed publications and presentations at national and international scientific conferences. Trial registration number NCT06375369

OBJECTIVES:Economic evaluations increasingly inform adoption and reimbursement decisions for medical devices; yet, existing quality assessment tools were largely developed for pharmaceuticals and may not adequately capture device-specific methodological challenges. The objective of the medical Device Economic Evaluation Methodological Quality assessment study was to develop a consensus-based instrument for assessing the methodological quality of economic evaluations of medical devices. METHODS:Candidate items were identified through a systematic review of existing methodological quality assessment tools and economic evaluation guidelines, including those from Canada's Drug Agency. A 2-round modified e-Delphi study was conducted with 40 health economists experienced in Canadian medical device evaluation (response rates: 100% and 90% for rounds 1 and 2, respectively). Using a 9-point importance scale, items were retained if ≥70% of participants rated them as critical (scores 7-9) and ≤15% rated them as not important (scores 1-3). The resulting checklist underwent pilot testing for clarity, applicability, and consistency. RESULTS:The initial 49 items were refined to 39, covering general economic evaluation domains (decision problem, comparators, perspective, time horizon, modeling, analysis, and uncertainty) and device-specific considerations (evidence gaps, learning curve, organizational impacts, incremental innovation, and diversity). Pilot testing confirmed clarity and consistent application. CONCLUSIONS:The Device Economic Evaluation Methodological Quality assessment represents the first consensus-based checklist for assessing the methodological quality of medical device economic evaluations. It provides a practical tool for researchers, reviewers, and decision makers. A companion explanation and elaboration document has been developed to support consistent interpretation and application across decision contexts.

The novel Coronavirus Disease 2019 (COVID-19) can have lasting physical and psychological outcomes, though little is known about the long-term impact of COVID-19 on the health-related quality of life (HRQoL) of Canadians. The aim of this study is to estimate the impacts of testing positive for COVID-19 using the EQ-5D-5 L instrument. Our study is a secondary analysis of data collected in the Alberta POST-COVID-19 Follow-up Study, linking survey responses to administrative health data. The data included 11,705 individuals tested for COVID-19 in Alberta from October 2021 to September 2023. Survey data included test results, age, sex, and EQ-5D-5 L response. Linked administrative data included socioeconomic status, comorbidities, hospital, and intensive care unit admissions. We used linear regression to estimate differences in HRQoL pre- and post-COVID-19 testing and ordinal logistic regression to estimate the odds of worsening HRQoL in each of the EQ-5D domains. COVID-19-positive individuals were younger (mean 48.5 vs. 53.4 years), more often female (64.4

OBJECTIVES:Health economic evaluations are important for healthcare resource allocation. Reviews of health economic evaluations for medical devices have highlighted concerns about the quality of these studies. The complexity of medical devices, including learning curve effects, organizational impact, dynamic pricing, low evidence, and incremental innovation presents unique challenges compared with pharmaceuticals. To support developing a methodological quality assessment instrument for medical device economic evaluations, we conducted a systematic review to identify and evaluate existing economic evaluation quality assessment instruments for suitability in medical device evaluations. METHODS:A comprehensive search of databases (MEDLINE, EMBASE, EconLit, CINAHL, and Web of Science) and grey literature was conducted. Two reviewers screened titles and abstracts. Full-text, peer-reviewed primary studies introducing original instruments were included. Only methodological quality assessment instruments were considered for data extraction. Each item was assessed for its suitability in evaluating medical device economic evaluations and inclusion of medical device-specific features. RESULTS:The search identified 4203 citations and 77 grey literature sources. Fifteen results underwent full-text assessment, with five relevant instruments identified. A previous systematic review identified 10 additional instruments, which we also considered. Of these 25 articles, 13 were included in the review. These instruments lack specificity for medical devices, particularly in addressing features like learning curve effects, organizational impact, and incremental innovation. Instruments should include items specific to these unique characteristics. CONCLUSIONS:Existing instruments contain general items related to health economic evaluation studies, highlighting the need for an instrument specifically tailored to evaluate the methodological quality of medical device economic evaluation studies.

Spinal muscular atrophy (SMA) is a neuromuscular disorder caused by the loss of the SMN1 gene, with an estimated birth prevalence of about 1 in 10,000. Early intervention with disease-modifying therapies (DMTs) significantly improves outcomes. This study evaluates the economic implications and health benefits of newborn screening (NBS) for SMA in Canada from the societal perspective. A decision analytic model was developed, which combined a decision tree for the screening algorithm and a Markov model for long-term health outcomes. The Markov model included health states based on WHO motor milestones. The population cohort of 357,903 live newborns reflects the 2022–2023 births in Canada. Screening is performed on dried blood spot testing which evaluates for biallelic deletions in SMN1. Cost inputs encompassed treatment and health state costs, while utility values reflected quality of life in each health state. NBS for SMA is expected to identify 37.1 (95

OBJECTIVES:The aim of this study is to develop a patient-level model for type 2 diabetes mellitus (T2DM) progression that can estimate the cost-effectiveness of T2DM interventions from prevention to management. METHODS:We developed an individual-level microsimulation model, the Institute of Health Economics Diabetes Model (IHE-DM), that simulates: (i) T2DM progression from normal glucose tolerance (NGT) to T2DM, (ii) the occurrence and timing of eight comorbidities and death, and (iii) the correlated progression of risk factors over time. We report model validation and use a case study to investigate the cost-effectiveness of a hypothetical T2DM prevention program. RESULTS:The internal validation indicated excellent performance with mean absolute differences between the predicted and observed values for all endpoints of less than 1 percent. External validation results were mixed. The model under-predicted cumulative T2DM incidence in the first 8 years, predicted well from years eight through eleven, and over-predicted from years twelve through fifteen. Our case study estimated an incremental net monetary benefit of CAD 2,701 (USD 2,289) (95% Uncertainty Interval: CAD 1,316 to 4,000 [USD 1,115 to 3,390]) over the 15-year time horizon. CONCLUSIONS:Prominent T2DM models focus on patients with diagnosed T2DM whereas our model simulates progression from NGT to T2DM and incorporates important correlations in the progression of risk factors. These adaptations allow us to evaluate preventative interventions and better capture the long-term impacts, filling an important gap in the evidence base. Our model can be used to inform future funding decisions for T2DM interventions across the care continuum.

BACKGROUND:Polypharmacy is a major and growing challenge for patient safety and health outcomes, and associated with inefficient use of resources. Management requires balancing therapeutic benefits and risks, aligned with clinical and patient priorities. High-quality evidence supporting current guidance for the management of polypharmacy is scarce. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) study was to examine whether a complex intervention could reduce potentially inappropriate prescribing among patients experiencing polypharmacy in primary care. METHODS:A pragmatic, open-label, two-arm, parallel cluster-randomised trial was conducted in UK general practices providing National Health Service primary medical care. Practices were required to use the EMIS electronic health records system and have more than 4000 registered patients. For inclusion in the study, participants were required to be aged 18 years or older, prescribed at least five regular medications (ie, medicines recorded in the clinical system as repeat prescriptions, and thus available for recurrent ordering by patients without having to see a clinician) irrespective of when the drug was last issued, and with at least one indicator of potentially inappropriate prescribing identified by an informatics tool. Practices were randomly allocated to deliver the polypharmacy intervention or continue usual care. The complex intervention comprised a structured, collaborative, and patient-centred approach to medication review, supported by informatics, clinician training, performance feedback, and financial incentivisation. In each practice, adults receiving five or more regular medications, with at least one indicator of potentially inappropriate prescribing, were reviewed over a 6-month period. The primary outcome was number of indicators of potentially inappropriate prescribing at 26 weeks' follow-up, analysed on an intention-to-treat basis. The trial was registered with the ISRCTN registry (90146150) and is complete. FINDINGS:Between Jan 26, 2022, and June 20, 2022, 37 general practices were recruited. 33 745 patients were potentially eligible, and 11 022 of these were randomly sampled for study inclusion. 1471 were excluded after general practitioner screening, 9551 were invited to participate, and 1950 provided consent and were randomly assigned (944 patients from 18 practices assigned to usual care and 1006 patients from 19 practices assigned to the intervention). 1727 participants were enrolled in the trial (836 in the usual care group and 891 in the intervention group). Participants' median age was 73 years (IQR 66-79), 881 (51%) were male and 846 (49%) were female, and they had a median of four long-term conditions and a median of eight medications. There was no evidence of a difference in the primary outcome of number of potentially inappropriate prescribing indicators at the 26-week follow-up between the intervention and control groups after adjustment for pre-randomisation baseline (mean 2·3 in each group; difference in means -0·007 [95% CI -0·21 to 0·20]; p=0·95). There were 13 deaths and 99 people with one or more unplanned admissions in the intervention group, and 12 deaths and 91 people with one or more unplanned admissions in the control group. None of the admissions or deaths were deemed to be related to the intervention. INTERPRETATION:A complex medication optimisation intervention did not reduce potentially inappropriate prescribing in patients with polypharmacy. The findings are at odds with the current policy drive for digital health-care solutions, investment in clinical pharmacy staff, and promotion of structured medication reviews. Effective use of such strategies should be revisited accordingly. FUNDING:National Institute for Health and Care Research.

1. The prescribing of multiple medicines to one individual, or polypharmacy, is increasingly common. While the use of multiple medications by a patient is often appropriate, in some cases prescribed medicines may not have the intended benefit and may even cause harm, and it is important to understand the clinical and economic implications of polypharmacy and interventions to optimise prescribing. In the UK, most ongoing clinical management of polypharmacy takes place in primary care. We estimated the cost-effectiveness of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial from a UK NHS perspective. IMPPP was a pragmatic, open-label, two-arm cluster-randomised trial across 37 English general practices, including 1,715 patients. The intervention comprised a structured, enhanced process for delivering patient-centred polypharmacy reviews, and was compared to control arm practices delivering usual care. Costs were derived from routine electronic health records including primary and secondary care service utilisation data whilst QALYs were estimated via SF-12v2. Follow-up was assessed at 6 months compared to pre-randomisation baseline. Cost-effectiveness was assessed using multilevel modelling with bias-corrected and accelerated bootstrapping to calculate 95% confidence intervals. Additional one-way sensitivity analyses were conducted to explore uncertainty. Adjusted mean QALYs were slightly higher in the intervention group (0.629) versus control (0.624), with a non-significant difference of 0.006 (95% CI: -0.002 to 0.014). Mean adjusted costs were also higher in the intervention group (£4166 vs. £3655), with a non-significant cost difference of £511 (95% CI: -£73 to £949). The probability of cost-effectiveness at National Institute for the Health and Care Excellence’s £20,000/QALY and £30,000/QALY thresholds were 6% and 12% respectively. Complete case analysis showed a £138 NHS cost reduction (95% CI: -£652 to £376) and a QALY gain of 0.012 (95% CI: 0.004 to 0.021). Polypharmacy medication review as conducted in the IMPPP trial is not cost-effective. This probably reflects multiple factors, including clinical effectiveness outcomes and key cost outcomes being relatively insensitive to the intervention.

ObjectiveEvaluate the quality and cost-effectiveness of economic evaluations of newborn screening (NBS) for Spinal Muscular Atrophy (SMA).MethodsA systematic review was conducted following Cochrane Handbook guidelines and PRISMA-S checklist. From 146 identified papers, 22 were screened for full-text, and 5 were included. Studies were evaluated for quality of reporting and transparency using the CHEERs and QHES checklists. Data was extracted to inform the review.ResultsFour economic evaluations on NBS for SMA with high reporting quality were identified. Each study employed a cost-utility analysis with similar model structures, using a decision tree for screening and a Markov model for treatment outcomes. They each compared NBS with treatment vs clinical diagnosis (no screening) with treatment. Although treatment protocols of each study varied due to differences in the strategies considered and availability of treatment. All studies included a societal perspective in their analysis and considered a lifetime horizon ranging from 30 months to 100 years. Early NBS with treatment was found to be more cost-effective than late treatment in all studies with ICER values ranging from £-117,541 to $714,000 per QALY. The wide range of ICER values are due to assumptions of long-term outcomes which are still largely unknown.ConclusionNBS with treatment was found to be cost-effective by all studies when compared to no NBS and late treatment. Although there is uncertainty around long term outcomes. Future research should focus on collecting long-term efficacy and safety data and evaluating the cost-effectiveness of pre-symptomatic treatment.

BACKGROUND:During public health crises such as the COVID-19 pandemic, decision-makers relied on infectious disease models to evaluate policy options. Often, there is a high degree of uncertainty in the evidence base underpinning these models. When there is increased uncertainty, the risk of selecting a policy option that does not align with the intended policy objective also increases; we term this decision risk. Even when models adequately capture uncertainty, the tools used to communicate their outcomes, underlying uncertainty, and associated decision risk have often been insufficient. Our aim is to support infectious disease modellers and decision-makers in interpreting and communicating decision risk when evaluating multiple policy options. METHODS:We developed the Decision Uncertainty Toolkit by adapting methods from health economics and infectious disease modelling to improve the interpretation and communication of uncertainty. Specifically, we developed a quantitative measure of decision risk as well as a suite of risk visualizations. We refined the toolkit contents based on feedback from early dissemination through conferences and workshops. RESULTS:The Decision Uncertainty Toolkit: (i) adapts and extends existing health economics methods for characterization, estimation, and communication of uncertainty to infectious disease modelling, (ii) introduces a novel risk measure that quantitatively captures the downside risk of policy alternatives, (iii) provides visual outputs for dissemination and communication of uncertainty and decision risk, and (iv) includes instructions on how to use the toolkit, standard text descriptions and examples for each component. The use of the toolkit is demonstrated through a hypothetical example. CONCLUSION:The Decision Uncertainty Toolkit improves existing methods for communicating infectious disease model results by providing additional information regarding uncertainty and decision risk associated with policy alternatives. This empowers decision-makers to consider and evaluate decision risk more effectively when making policy decisions. Improved understanding of decision risk can improve outcomes in future public health crises.

Importance:Little is known about the long-term costs and outcomes related to strategies for timing of initiation of kidney replacement therapy (KRT) in critically ill patients with severe acute kidney injury (AKI). Objective:To estimate the cost-utility and cost-effectiveness of accelerated KRT initiation compared with standard KRT initiation in critically ill patients with AKI. Design, Setting, and Participants:In this economic evaluation, a state-transition model was developed using data from the Standard vs Accelerated Initiation of Renal Replacement Therapy in AKI (STARRT-AKI) trial, a multicenter, multinational randomized clinical trial of critically ill patients with severe AKI conducted between October 2015 and September 2019. Trial data were linked to administrative health databases in Alberta, Canada, to estimate costs and long-term clinical outcomes. The model included 4 health states: no chronic kidney disease, severe chronic kidney disease, KRT dependent, and dead. Costs are reported in 2024 Canadian dollars. Data were analyzed from February 2022 to November 2024. Exposure:Initiation of KRT. Main Outcomes and Measures:The primary outcome for the economic evaluation was cost per quality-adjusted life-year (QALY) gained. The QALY is a combined measure of patient quality of life and length of life. Expected costs, QALYs, incremental cost-effectiveness ratio (ICER), and incremental net monetary benefit (INMB) were estimated on the basis of 5000 Monte Carlo simulations. Results:A total of 146 patients from the STARRT-AKI trial were included in the analysis, with 73 patients (mean [SD] age, 59.67 [14.5] years; 52 men [71.3%]) randomized to receive accelerated initiation and 73 patients (mean [SD] age, 61.88 [12.9] years; 48 men [65.8%]) randomized to receive standard initiation. Standard initiation was more costly per patient than accelerated initiation (mean [SD], $251 370 [$155 801] vs $231 518 [$183 302]) but generated more QALYs (mean [SD] 7.49 [2.03] QALYs vs 6.64 [1.76] QALYs). The ICER of standard initiation compared with accelerated initiation was $23 208, with an INMB of $22 648 (95% credible interval, $15 980-$29 316) when assuming a willingness to pay per QALY of $50 000. Conclusions and Relevance:The findings of this economic evaluation suggest that standard KRT initiation may be cost-effective in a Canadian setting, but this finding was sensitive to postdischarge cost trajectories and regional variation in KRT dependence.

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 healthrelated 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.

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.

IntroductionBone-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.MethodsA 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.ResultsFifty 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.DiscussionThe 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.

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.

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 12week follow-up.