Uptake of health economic evaluations alongside clinical trials in Australia: an observational study.

BACKGROUND: Australia's clinical trials sector is highly productive with continued sector investment needed to enhance research impact. Generating economic evidence alongside trials has the potential to facilitate the implementation of trial results into practice. Ascertaining the use of health economic evaluations alongside clinical trials can assist in determining whether clinical trials fully realize and operationalize their potential to change policy and practice. The aims of this study were to ascertain the uptake of health economic evaluations alongside Australian-led clinical trials and explore associations between uptake and trial characteristics. METHODS: This observational study comprised a descriptive analysis of clinical trials registries, a cross-sectional survey of Australian Clinical Trials Alliance (ACTA) networks, and a subgroup analysis of completed acute care trials. Descriptive analyses of trial registrations were conducted, with logistic regressions used to identify predictors of proposing and subsequently publishing a health economic evaluation alongside acute care trials. RESULTS: Few randomized Australian-led clinical trials (11% of 9251) and ACTA network trials (43% of 227) proposed a health economic evaluation. In the subgroup analysis, 22% of the 324 acute care trials and 53% of the 38 ACTA network acute care trials proposed a health economic evaluation. Acute care trials funded by government bodies were significantly more likely to propose and publish a health economic evaluation than those funded by hospitals, universities, and other funders, after adjusting for phase, registration year, primary sponsor type, and comparator. CONCLUSIONS: Current uptake of health economic evaluations alongside Australian-led clinical trials is low, with uptake higher among the subset of ACTA network trials. This is despite economic evidence playing an increasingly prominent role in health system management, as well as rising health expenditure, limited budgets, and competing demands. There is significant opportunity to embed health economic evaluations alongside clinical trials, particularly phase 3 trials, to increase research outputs and optimize research translation. Investing in clinical trial networks that support funding for a health economist or a health economic evaluation may be an effective strategy to increase the uptake of health economic evaluations alongside trials.

Costs of Australian intensive care: A systematic review.

Objective: Intensive care unit (ICU) cost estimates are critical to achieving healthcare system efficiency and sustainability. We aimed to review the published literature describing ICU costs in Australia. Design: A systematic review was conducted to identify studies that estimated the cost of ICU care in Australia. Studies conducted in specific patient cohorts or on specific treatments were excluded. Data sources: Relevant studies were sourced from a previously published review (1970-2016), a systematic search of MEDLINE and EMBASE (2016-5 May 2023), and reference checking. Review methods: A tool was developed to assess study quality and risk of bias (maximum score 57/57). Total and component costs were tabulated and indexed to 2022 Australian Dollars. Costing methodologies and study quality assessments were summarised. Results: Six costing studies met the inclusion criteria. Study quality scores were low (15/41 to 35/47). Most studies were conducted only in tertiary metropolitan public ICUs; sample sizes ranged from 100 to 10,204 patients. One study used data collected within the past 10 years. Mean daily ICU costs ranged from $966 to $5381 and mean total ICU admission costs $4888 to $14,606. Three studies used a top-down costing approach, deriving cost estimates from budget reports. The other three studies used both bottom-up and top-down costing approaches. Bottom-up approaches collected individual patient resource use. Conclusions: Available ICU cost estimates are largely outdated and lack granular data. Future research is needed to estimate ICU costs that better reflect current practice and patient complexity and to determine the best methods for generating these estimates.

Operationalizing the Consolidated Framework for Implementation Research to build and support the lived experience workforce in direct health service provision.

BACKGROUND: The involvement of people with lived experience (LEX) workers in the development, design, and delivery of integrated health services seeks to improve service user engagement and health outcomes and reduce healthcare gaps. Yet, LEX workers report feeling undervalued and having limited influence on service delivery. There is a need for systematic improvements in how LEX workforces are engaged and supported to ensure the LEX workforce can fully contribute to integrated systems of care. OBJECTIVE: This study aimed to operationalize the Consolidated Framework for Implementation Research (CFIR) using a rigorous scoping review methodology and co-creation process, so it could be used by health services seeking to build and strengthen their LEX workforce. SEARCH STRATEGY: A systematic literature search of four databases was undertaken to identify peer-reviewed studies published between 2016 and 2022 providing evidence of the inclusion of LEX workers in direct health service provision. DATA EXTRACTION AND SYNTHESIS: A descriptive-analytical method was used to map current evidence of LEX workers onto the CFIR. Then, co-creation sessions with LEX workers (n = 4) and their counterparts-nonpeer workers (n = 2)-further clarified the structural policies and strategies that allow people with LEX to actively participate in the provision and enhancement of integrated health service delivery. MAIN RESULTS: Essential components underpinning the successful integration of LEX roles included: the capacity to engage in a co-creation process with individuals with LEX before the implementation of the role or intervention; and enhanced representation of LEX across organizational structures. DISCUSSION AND CONCLUSION: The adapted CFIR for LEX workers (CFIR-LEX) that was developed as a result of this work clarifies contextual components that support the successful integration of LEX roles into the development, design, and delivery of integrated health services. Further work must be done to operationalize the framework in a local context and to better understand the ongoing application of the framework in a health setting. PATIENT OR PUBLIC CONTRIBUTION: People with LEX were involved in the operationalization of the CFIR, including contributing their expertise to the domain adaptations that were relevant to the LEX workforce.

Economic evaluations performed alongside randomized implementation trials in clinical settings: a systematic review.

BACKGROUND: Economic evaluations alongside implementation trials compare the outcomes and costs of competing implementation strategies to identify the most efficient strategies. The aims of this systematic review were to investigate how economic evaluations are performed in randomized implementation trials in clinical settings and to assess the quality of these evaluations. METHODS: A systematic literature review was conducted on 23 March 2023 to identify studies that reported on economic evaluations embedded in randomized implementation trials in clinical settings. A systematic search was applied across seven databases, and references of relevant reviews were screened for additional studies. The Drummond Checklist was used to assess the quality and risk of bias of included economic evaluations. Study characteristics and quality assessments were tabulated and described. RESULTS: Of the 6,550 studies screened for eligibility, 10 met the inclusion criteria. Included studies were published between 1990 and 2022 and from North America, the United Kingdom, Europe, and Africa. Most studies were conducted in the primary and out-patient care setting. Implementation costs included materials, staffing, and training, and the most common approach to collecting implementation costs was obtaining expense and budget reports. Included studies scored medium to high in terms of economic methodological quality. CONCLUSIONS: Economic evidence is particularly useful for healthcare funders and service providers to inform the prioritization of implementation efforts in the context of limited resources and competing demands. The relatively small number of studies identified may be due to lack of guidance on how to conduct economic evaluations alongside implementation trials and the lack of standardized terminology used to describe implementation strategies in clinical research. We discuss these methodological gaps and present recommendations for embedding economic evaluations in implementation trials. First, reporting implementation strategies used in clinical trials and aligning these strategies with implementation outcomes and costs are an important advancement in clinical research. Second, economic evaluations of implementation trials should follow guidelines for standard clinical trial economic evaluations and adopt an appropriate costing and data collection approach. Third, hybrid trial designs are recommended to generate evidence for effective and cost-effective implementation strategies alongside clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION: The review was prospectively registered with PROSPERO (CRD42023410186).

Midwife-led birthing centres in Bangladesh, Pakistan and Uganda: an economic evaluation of case study sites.

INTRODUCTION: Achieving the Sustainable Development Goals to reduce maternal and neonatal mortality rates will require the expansion and strengthening of quality maternal health services. Midwife-led birth centres (MLBCs) are an alternative to hospital-based care for low-risk pregnancies where the lead professional at the time of birth is a trained midwife. These have been used in many countries to improve birth outcomes. METHODS: The cost analysis used primary data collection from four MLBCs in Bangladesh, Pakistan and Uganda (n=12 MLBC sites). Modelled cost-effectiveness analysis was conducted to compare the incremental cost-effectiveness ratio (ICER), measured as incremental cost per disability-adjusted life-year (DALY) averted, of MLBCs to standard care in each country. Results were presented in 2022 US dollars. RESULTS: Cost per birth in MLBCs varied greatly within and between countries, from US$21 per birth at site 3, Bangladesh to US$2374 at site 2, Uganda. Midwife salary and facility operation costs were the primary drivers of costs in most MLBCs. Six of the 12 MLBCs produced better health outcomes at a lower cost (dominated) compared with standard care; and three produced better health outcomes at a higher cost compared with standard care, with ICERs ranging from US$571/DALY averted to US$55 942/DALY averted. CONCLUSION: MLBCs appear to be able to produce better health outcomes at lower cost or be highly cost-effective compared with standard care. Costs do vary across sites and settings, and so further exploration of costs and cost-effectiveness as a part of implementation and establishment activities should be a priority.

How environmental impact is considered in economic evaluations of critical care: a scoping review.

PURPOSE: Health care is a major contributor to climate change, and critical care is one of the sector's highest carbon emitters. Health economic evaluations form an important component of critical care and may be useful in identifying economically efficient and environmentally sustainable strategies. The purpose of this scoping review was to synthesise available literature on whether and how environmental impact is considered in health economic evaluations of critical care. METHODS: A robust scoping review methodology was used to identify studies reporting on environmental impact in health economic evaluations of critical care. We searched six academic databases to locate health economic evaluations, costing studies and life cycle assessments of critical care from 1993 to present. RESULTS: Four studies met the review's inclusion criteria. Of the 278 health economic evaluations of critical care identified, none incorporated environmental impact into their assessments. Most included studies (n = 3/4) were life cycle assessments, and the remaining study was a prospective observational study. Life cycle assessments used a combination of process-based data collection and modelling to incorporate environmental impact into their economic assessments. CONCLUSIONS: Health economic evaluations of critical care have not yet incorporated environmental impact into their assessments, and few life cycle assessments exist that are specific to critical care therapies and treatments. Guidelines and standardisation regarding environmental data collection and reporting in health care are needed to support further research in the field. In the meantime, those planning health economic evaluations should include a process-based life cycle assessment to establish key environmental impacts specific to critical care.

Patterns in the provision of government-subsidised hormonal postpartum contraception in Queensland, Australia between 2012 and 2018: a population-based cohort study.

BACKGROUND: Short birth intervals and unintended pregnancy are associated with poorer maternal and infant outcomes. There is a risk of pregnancy during the immediate postpartum period unless contraception is initiated. This retrospective cohort study aimed to capture the current patterns of hormonal contraceptive provision within 12 months postpartum in a high-income country. METHODS: We used a linked administrative dataset comprising all women who gave birth in Queensland, Australia between 1 July 2012 and 30 June 2018 (n=339 265 pregnancies). We described our cohort by whether they were provided with government-subsidised hormonal contraception within 12 months postpartum. The associations between hormonal postpartum contraceptive provision and demographic and clinical characteristics were examined using univariate and multivariate logistic regression and presented in terms of crude and adjusted odds ratios with 95% confidence intervals. RESULTS: A majority of women (60.2%) were not provided with government-subsidised hormonal postpartum contraception within 12 months postpartum. Women who were younger (<25 years), were overweight or obese, smoked, were born in Australia, were non-Indigenous, gave birth in a public hospital, or were in the lowest socioeconomic status group were more likely to be provided with postpartum contraception after adjusting for other covariates, compared with their counterparts. CONCLUSIONS: Strategies to increase the provision and uptake of contraception in the immediate postpartum period are needed to prevent short birth intervals and unintended pregnancy and ensure women's fertility intentions are enacted. Ongoing research is needed to examine the factors influencing women's access to contraceptive services and, further, the types of contraception provided.

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review.

Objective: Pregnant women are increasingly turning to apps targeting knowledge and behaviour change for supporting healthy lifestyles and managing medical conditions. Yet, there is growing concern over the credibility and safety of content within mobile health (mHealth) apps. This scoping review aimed to systematically and thematically consolidate safety considerations described in reviews evaluating pregnancy-specific apps. Methods: PubMed, Ovid MEDLINE® and EPub, CINAHL, Web of Science, Cochrane Libraries, and SCOPUS were systematically searched to identify reviews that assessed apps targeting pregnant women. Data related to safety were extracted and thematically analysed to establish a set of relevant safety considerations. Results: Sixteen reviews met the inclusion criteria. The included reviews assessed an average of 27 apps each and targeted pregnancy topics, such as nutrition and physical activity. Five major and 20 minor themes were identified, including information, transparency, credibility, privacy and security, and app tailoring. Information, transparency, and credibility relate to the evidence base of information within the app, privacy and security of apps relate to the protection of personal information and data, and app tailoring relates to the consideration of contextual factors, such as local guidelines and digital health literacy. Conclusions: Results present possible safety considerations when evaluating pregnancy-specific apps and emphasise a clear need for consumer guidance on how to make informed decisions around engagement and use of mHealth apps during pregnancy.

Development, woman-centricity and psychometric properties of maternity patient-reported experience measures: a systematic review.

OBJECTIVE: Valid and reliable maternity patient-reported experience measures are critical to understanding women's experiences of care. They can support clinical practice, health service and system performance measurement, and research. The aim of this review is to identify and critically appraise the risk of bias, woman-centricity (content validity), and psychometric properties of maternity patient-reported experience measures published in the scientific literature. DATA SOURCES: MEDLINE, CINAHL Plus, PsycINFO, and Embase were systematically searched for relevant records between January 1, 2010 and July 10, 2021. STUDY ELIGIBILITY CRITERIA: We searched for articles describing the instrument development of maternity patient-reported experience measures and measurement properties associated with instrument validity and reliability testing. Articles that described patient-reported experience measures developed outside of the maternity context and articles that did not contribute to the instruments' development, content validation, and/or psychometric evaluation were excluded. METHODS: Included articles underwent risk of bias, content validity, and psychometric properties assessments in line with the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) guidance. Patient-reported experience measure results were summarized according to language subgroups. An overall recommendation for use was determined for each patient-reported experience measure language subgroup. RESULTS: A total of 54 studies reported on the development and psychometric evaluation of 25 maternity patient-reported experience measures, grouped into 45 language subgroups. The quality of evidence underpinning the instruments' development was generally poor. Only 2 (4.4%) patient-reported experience measures reported sufficient content validity, and only 1 (2.2%) received a level "A" recommendation, required for real-world use. CONCLUSION: Maternity patient-reported experience measures demonstrated poor-quality evidence for their measurement properties and insufficient detail about content validity. Future maternity patient-reported experience measure development needs to prioritize women's involvement in deciding what is relevant, comprehensive, and comprehensible to measure. Improving the content validity of maternity patient-reported experience measures will improve overall validity and reliability and facilitate real-world practice improvements. Standardized patient-reported experience measure implementation also needs to be prioritized to support advancements in clinical practice for women.

Systematic review on the cost and cost-effectiveness of mHealth interventions supporting women during pregnancy.

OBJECTIVES: The increased integration of digital health into maternity care-alongside growing use of, and access to, personal digital technology among pregnant women-warrants an investigation of the cost-effectiveness of mHealth interventions used by women during pregnancy and the methodological quality of the cost-effectiveness studies. METHODS: A systematic search was conducted to identify peer-reviewed studies published in the last ten years (2011-2021) reporting on the costs or cost-effectiveness of mHealth interventions used by women during pregnancy. Available data related to program costs, total incremental costs and incremental cost-effectiveness ratios (ICERs) were reported in 2020 United States Dollars. The quality of cost-effectiveness studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). FINDINGS: Nine articles reporting on eight studies met the inclusion criteria. Direct intervention costs ranged from $7.04 to $86 per woman, total program costs ranged from $241,341 to $331,136 and total incremental costs ranged from -$21.16 to $1.12 million per woman. The following ICERs were reported: $2168 per DALY averted, $203.44 per woman ceasing smoking, and $3475 per QALY gained. The full economic evaluation studies (n = 4) were moderate to high in quality and all reported the mHealth intervention as cost-effective. Other studies (n = 4) were low to moderate in quality and reported low costs or cost savings associated with the implementation of the mHealth intervention. CONCLUSIONS FOR PRACTICE: Preliminary evidence suggests mHealth interventions may be cost-effective and "low-cost" but more evidence is needed to ascertain the cost-effectiveness of mHealth interventions regarding positive maternal and child health outcomes and longer-term health service utilisation.

Key issues, challenges, and preferred supports for those bereaved by suicide: Insights from postvention experts.

For many, suicide bereavement is challenging. Postvention responses are few and evidence to inform them is lacking. Eighteen postvention experts completed an online survey regarding the key issues, challenges, and supports available to people bereaved by suicide. Participants were asked to identify the issues, then rank them in terms of importance at key times during the first 2 years after death, with navigating grief, managing relationships, and dealing with practical challenges identified. Access to information, practical assistance and non-judgmental support were most important early in the bereavement period. These findings provide a foundation for recommendations for postvention interventions.

Assessing the Content and Quality of Digital Tools for Managing Gestational Weight Gain: Systematic Search and Evaluation.

BACKGROUND: Digital health resources have the potential to assist women in optimizing gestational weight gain (GWG) during pregnancy to improve maternal health outcomes. OBJECTIVE: In this study, we aimed to evaluate the quality and behavior change potential of publicly available digital tools (websites and apps) that facilitate GWG tracking. METHODS: Digital tools were identified using key search terms across website search engines and app stores and evaluated using the Mobile App Rating Scale, the App Behavior Change Scale, as well as criteria to evaluate the rigor and safety of GWG information. RESULTS: Overall, 1085 tools were screened for inclusion (162 websites and 923 apps), and 19 were deemed eligible. The mean Mobile App Rating Scale quality score was 3.31 (SD 0.53) out of 5, ranging from 2.26 to 4.39, and the mean App Behavior Change Scale score was 6 (SD 3.4) out of 21, ranging from 19 to 0. Of the 19 items used to evaluate rigor of GWG advice, most tools (n=11, 57.9%) contained ≤3 items. CONCLUSIONS: This review emphasizes the substantial limitations in current digital resources promoting the monitoring and optimization of GWG. Most tools were of low quality, had minimal behavior change potential, and were potentially unsafe, with minimal linkage to evidence-based information or partnership with health care.

Health Economics and Equity in Preconception Health Care: A Systematic Review.

Poor pregnancy outcomes affect a child's lifelong health and disadvantaged populations are at higher risk of poor pregnancy outcomes. Preconception care aims to improve pregnancy outcomes by managing conditions and risks prior to conception. Given known inequities in pregnancy outcomes, the adoption of preconception care may benefit disadvantaged populations. Health economics plays an important role in the implementation of interventions, as economic evaluations seek to identify the most efficient and equitable care options. This review aimed to identify the cost-effectiveness of preconception care and how equity has been considered in these evaluations. A systematic review of literature published between 2012-2022 was undertaken to identify studies that evaluate the economic outcomes of preconception care. Studies that met the inclusion criteria were manually searched for consideration of equity in the economic evaluation analysis. Costs were presented and a narrative synthesis of studies reporting on outcomes of equity was conducted. Eight studies met the inclusion criteria, and only two reported on aspects of equity, specifically ethnicity. Considering the significant disparities in pregnancy outcomes among disadvantaged populations, aspects of equity are important to consider when implementing and evaluating preconception interventions. Therefore, it is recommended that future research focuses on the cost-effectiveness of preconception care and that these evaluations incorporate aspects of equity.