An overview of the perspectives used in health economic evaluations.

The term 'perspective' in the context of economic evaluations and costing studies in healthcare refers to the viewpoint that an analyst has adopted to define the types of costs and outcomes to consider in their studies. However, there are currently notable variations in terms of methodological recommendations, definitions, and applications of different perspectives, depending on the objective or intended user of the study. This can make it a complex area for stakeholders when interpreting these studies. Consequently, there is a need for a comprehensive overview regarding the different types of perspectives employed in such analyses, along with the corresponding implications of their use. This is particularly important, in the context of low-and-middle-income countries (LMICs), where practical guidelines may be less well-established and infrastructure for conducting economic evaluations may be more limited. This article addresses this gap by summarising the main types of perspectives commonly found in the literature to a broad audience (namely the patient, payer, health care providers, healthcare sector, health system, and societal perspectives), providing their most established definitions and outlining the corresponding implications of their uses in health economic studies, with examples particularly from LMIC settings. We then discuss important considerations when selecting the perspective and present key arguments to consider when deciding whether the societal perspective should be used. We conclude that there is no one-size-fits-all answer to what perspective should be used and the perspective chosen will be influenced by the context, policymakers'/stakeholders' viewpoints, resource/data availability, and intended use of the analysis. Moving forward, considering the ongoing issues regarding the variation in terminology and practice in this area, we urge that more standardised definitions of the different perspectives and the boundaries between them are further developed to support future studies and guidelines, as well as to improve the interpretation and comparison of health economic evidence.

Gender disparities in lost productivity resulting from non-communicable diseases in Mexico, 2005-2021.

Background: Non-communicable diseases (NCDs) cause long-term impacts on health and can substantially affect people's ability to work. Little is known about how such impacts vary by gender, particularly in low- and middle-income countries (LMICs), where productivity losses may affect economic development. This study assessed the long-term productivity loss caused by major NCDs among adult women and men (20-76 years) in Mexico because of premature death and hospitalisations, between 2005 and 2021. Methods: We conducted an economic valuation based on the Human Capital Approach. We obtained population-based data from the National Employment Survey from 2005 to 2021 to estimate the expected productivity according to age and gender using a two-part model. We utilised expected productivity based on wage rates to calculate the productivity loss, employing Mexican official mortality registries and hospital discharge microdata for the same period. To assess the variability in our estimations, we performed sensitivity analyses under two different scenarios. Results: Premature mortality by cancers, diabetes, chronic cardiovascular diseases (CVD), chronic respiratory diseases (CRD) and chronic kidney disease (CKD) caused a productivity loss of 102.6 billion international US dollars (Intl. USD) from 2.8 million premature deaths. Seventy-three percent of this productivity loss was observed among men. Cancers caused 38.3% of the productivity loss (mainly among women), diabetes 38.1, CVD 15.1, CRD 3.2, and CKD 5.3%. Regarding hospitalisations, the estimated productivity loss was 729.7 million Intl. USD from 54.2 million days of hospitalisation. Men faced 65.4 and women 34.6% of these costs. Cancers caused 41.3% of the productivity loss mainly by women, followed by diabetes (22.1%), CKD (20.4%), CVD (13.6%) and CRD (2.6%). Conclusions: Major NCDs impose substantial costs from lost productivity in Mexico and these tend to be higher amongst men, while for some diseases the economic burden is higher for women. This should be considered to inform policymakers to design effective gender-sensitive health and social protection interventions to tackle the burden of NCDs.

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP®/Haemocomplettan® P).

Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP®/Haemocomplettan® P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986-June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding.

Overcoming silos in health care systems through meso-level organisations - a case study of health reforms in New South Wales, Australia.

Fragmented care delivery is a barrier to improving health system performance worldwide. Investment in meso-level organisations is a potential strategy to improve health system integration, however, its effectiveness remains unclear. In this paper, we provide an overview of key international and Australian integrated care policies. We then describe Collaborative Commissioning - a novel health reform policy to integrate primary and hospital care sectors in New South Wales (NSW), Australia and provide a case study of a model focussed on older person's care. The policy is theorised to achieve greater integration through improved governance (local stakeholders identifying as part of one health system), service delivery (communities perceive new services as preferable to status quo) and incentives (efficiency gains are reinvested locally with progressively higher value care achieved). If effectively implemented at scale, Collaborative Commissioning has potential to improve health system performance in Australia and will be of relevance to similar reform initiatives in other countries.

The role of funded partnerships in working towards decreasing COVID-19 vaccination disparities, United States, March 2021-December 2022.

During the COVID-19 vaccination rollout from March 2021- December 2022, the Centers for Disease Control and Prevention funded 110 primary and 1051 subrecipient partners at the national, state, local, and community-based level to improve COVID-19 vaccination access, confidence, demand, delivery, and equity in the United States. The partners implemented evidence-based strategies among racial and ethnic minority populations, rural populations, older adults, people with disabilities, people with chronic illness, people experiencing homelessness, and other groups disproportionately impacted by COVID-19. CDC also expanded existing partnerships with healthcare professional societies and other core public health partners, as well as developed innovative partnerships with organizations new to vaccination, including museums and libraries. Partners brought COVID-19 vaccine education into farm fields, local fairs, churches, community centers, barber and beauty shops, and, when possible, partnered with local healthcare providers to administer COVID-19 vaccines. Inclusive, hyper-localized outreach through partnerships with community-based organizations, faith-based organizations, vaccination providers, and local health departments was critical to increasing COVID-19 vaccine access and building a broad network of trusted messengers that promoted vaccine confidence. Data from monthly and quarterly REDCap reports and monthly partner calls showed that through these partnerships, more than 295,000 community-level spokespersons were trained as trusted messengers and more than 2.1 million COVID-19 vaccinations were administered at new or existing vaccination sites. More than 535,035 healthcare personnel were reached through outreach strategies. Quality improvement interventions were implemented in healthcare systems, long-term care settings, and community health centers resulting in changes to the clinical workflow to incorporate COVID-19 vaccine assessments, recommendations, and administration or referrals into routine office visits. Funded partners' activities improved COVID-19 vaccine access and addressed community concerns among racial and ethnic minority groups, as well as among people with barriers to vaccination due to chronic illness or disability, older age, lower income, or other factors.

A European regulatory pathway for Tidepool loop following clearance in the United States?

The recent clearance by the United States Food and Drug Administration of Tidepool Loop sets an important precedent within the medical device landscape. For the first time, an automated insulin delivery mobile application-based on an algorithm initially designed and developed by users -has been recognised as safe and effective by a regulatory body. The aim of this paper is twofold: firstly, we map out the regulatory pathways and processes that were navigated by Tidepool, the non-profit behind Tidepool Loop, in order to make this landmark moment possible. Secondly, we set out potential approvals processes in the European Union and United Kingdom with a view to examining the challenges to obtaining regulatory clearance for Tidepool Loop in these jurisdictions. In so doing, we highlight the significant differences, not only between the United States and European systems but also between the European Union and Great Britain systems. We conclude by arguing that the complexity encountered when seeking to introduce an innovative solution in different regulatory systems has the potential to act as a disincentive to open source developers from seeking regulatory approvals for such technologies in the future.

Burden of non-communicable diseases and behavioural risk factors in Mexico: Trends and gender observational analysis.

Background: There is scarce gender-disaggregated evidence on the burden of disease (BD) worldwide and this is particularly prominent in low- and middle-income countries. The objective of this study is to compare the BD caused by non-communicable diseases (NCDs) and related risk factors by gender in Mexican adults. Methods: We retrieved disability-adjusted life years (DALYs) estimates for diabetes, cancers and neoplasms, chronic cardiovascular diseases (CVDs), chronic respiratory diseases (CRDs), and chronic kidney disease (CKD) from the Global Burden of Disease (GBD) Study from 1990-2019. Age-standardized death rates were calculated using official mortality microdata from 2000 to 2020. Then, we analysed national health surveys to depict tobacco and alcohol use and physical inactivity from 2000-2018. Women-to-men DALYs and mortality rates and prevalence ratios (WMR) were calculated as a measure of gender gap. Findings: Regarding DALYs, WMR was >1 for diabetes, cancers, and CKD in 1990, indicating a higher burden in women. WMR decreased over time in all NCDs, except for CRDs, which increased to 0.78. However, WMR was <1 for all in 2019. The mortality-WMR was >1 for diabetes and cardiovascular diseases in 2000 and <1 for the rest of the conditions. The WMR decreased in all cases, except for CRDs, which was <1 in 2020. The WMR for tobacco and alcohol use remained under 1. For physical inactivity, it was >1 and increasing. Conclusions: The gender gap has changed for selected NCDs in favour of women, except for CRDs. Women face a lower BD and are less affected by tobacco and alcohol use but face a higher risk of physical inactivity. Policymakers should consider a gendered approach for designing effective policies to reduce the burden of NCDs and health inequities.

What are economic costs and when should they be used in health economic studies?

Economic analyses of healthcare interventions are an important consideration in evidence-based policymaking. A key component of such analyses is the costs of interventions, for which most are familiar with using budgets and expenditures. However, economic theory states that the true value of a good/service is the value of the next best alternative forgone as a result of using the resource and therefore observed prices or charges do not necessarily reflect the true economic value of resources. To address this, economic costs are a fundamental concept within (health) economics. Crucially, they are intended to reflect the resources' opportunity costs (the forgone opportunity to use those resources for another purpose) and they are based on the value of the resource's next-best alternative use that has been forgone. This is a broader conceptualization of a resource's value than its financial cost and recognizes that resources can have a value that may not be fully captured by their market price and that by using a resource it makes it unavailable for productive use elsewhere. Importantly, economic costs are preferred over financial costs for any health economic analyses aimed at informing decisions regarding the optimum allocation of the limited/competing resources available for healthcare (such as health economic evaluations), and they are also important when considering the replicability and sustainability of healthcare interventions. However, despite this, economic costs and the reasons why they are used is an area that can be misunderstood by professionals without an economic background. In this paper, we outline to a broader audience the principles behind economic costs and when and why they should be used within health economic analyses. We highlight that the difference between financial and economic costs and what adjustments are needed within cost calculations will be influenced by the context of the study, the perspective, and the objective.

Error traps in Pediatric Patient Blood Management in the Perioperative Period.

Patient blood management is a patient-centered evidence-based approach to improve patient outcomes by harnessing the patient's own hematopoietic system to optimize blood health while promoting patient safety and empowerment. Perioperative patient blood management is a standard of care in adult medicine, yet it is not commonly accepted in pediatrics. Raising awareness may be the first step in improving perioperative care for the anemic and/or bleeding child. This article highlights five preventable perioperative blood conservation error traps for children. The goal is to provide practical clinical guidance to improve preoperative diagnosis and treatment of anemia, facilitate recognition and treatment of massive hemorrhage, reduce unnecessary allogeneic blood transfusions, and decrease associated complications of anemia and blood component transfusions utilizing a patient/family-centered informed consent and shared decision-making approach.

A Gender-Based and Quasi-Experimental Study of the Catastrophic and Impoverishing Health-Care Expenditures in Mexican Households with Elderly Members, 2000-2020.

Latin America has experienced a rise in noncommunicable diseases (NCDs) which is having repercussions on the structuring of healthcare delivery and social protection for vulnerable populations. We examined catastrophic (CHE) and excessive (EHE, impoverishing and/or catastrophic) health care expenditures in Mexican households with and without elderly members (≥65 years), by gender of head of the households, during 2000-2020. We analyzed pooled cross-sectional data for 380,509 households from eleven rounds of the National Household Income and Expenditure Survey. Male- and female-headed households (MHHs and FHHs) were matched using propensity scores to control for gender bias in systematic differences regarding care-seeking (demand for healthcare) preferences. Adjusted probabilities of positive health expenditures, CHE and EHE were estimated using probit and two-stage probit models, respectively. Quintiles of EHE by state among FHHs with elderly members were also mapped. CHE and EHE were greater among FHHs than among MHHs (4.7% vs 3.9% and 5.5% vs 4.6%), and greater in FHHs with elderly members (5.8% vs 4.9% and 6.9% vs 5.8%). EHE in FHHs with elderly members varied geographically from 3.9% to 9.1%, being greater in less developed eastern, north-central and southeastern states. Compared with MHHs, FHHs face greater risks of CHE and EHE. This vulnerability is exacerbated in FHHs with elderly members, because of gender intersectional vulnerability. The present context, marked by a growing burden of NCDs and inequities amplified by COVID-19, makes key interlinkages across multiple Sustainable Development Goals (SDGs) apparent, and calls for urgent measures that strengthen social protection in health.

Influence of Fibrinogen Concentrate on Neonatal Clot Structure When Administered Ex Vivo After Cardiopulmonary Bypass.

BACKGROUND: Bleeding is a serious complication of cardiopulmonary bypass (CPB) in neonates. Blood product transfusions are often needed to adequately restore hemostasis, but are associated with significant risks. Thus, neonates would benefit from other effective, and safe, hemostatic therapies. The use of fibrinogen concentrate (FC; RiaSTAP, CSL Behring, Marburg, Germany) is growing in popularity, but has not been adequately studied in neonates. Here, we characterize structural and degradation effects on the neonatal fibrin network when FC is added ex vivo to plasma obtained after CPB. METHODS: After approval by the institutional review board and parental consent, blood samples were collected from neonates undergoing cardiac surgery and centrifuged to yield platelet poor plasma. Clots were formed ex vivo from plasma obtained at several time points: (1) baseline, (2) immediately post-CPB, and (3) post-transfusion of cryoprecipitate. In addition, we utilized post-CPB plasma to construct the following conditions: (4) post-CPB +0.5 mg/mL FC, and (5) post-CPB +0.9 mg/mL FC. The resultant fibrin networks were imaged using confocal microscopy to analyze overall structure, fiber density, and alignment. Clots were also analyzed using a microfluidic degradation assay. Fibrinogen content was quantified for all plasma samples. RESULTS: The addition of 0.5 or 0.9 mg/mL FC to post-CPB samples significantly enhanced the median fiber density when compared to untreated post-CPB samples (post-CPB = 0.44 [interquartile range {IQR}: 0.36-0.52], post-CPB +0.5 mg/mL FC = 0.69 [0.56-0.77], post-CPB +0.9 mg/mL FC = 0.87 [0.59-0.96]; P = .01 and P = .006, respectively). The addition of 0.9 mg/mL FC to post-CPB samples resulted in a greater fiber density than that observed after the in vivo transfusion of cryoprecipitate (post-transfusion = 0.54 [0.45-0.77], post-CPB +0.9 mg/mL FC = 0.87 [0.59-0.96]; P = .002). Median fiber alignment did not differ significantly between post-CPB samples and samples treated with FC. Degradation rates were not statistically significant from baseline values with either 0.5 or 0.9 mg/mL FC. In addition, we found a significant correlation between the difference in the baseline and post-CPB fibrinogen concentration with patient age ( P = .033) after controlling for weight. CONCLUSIONS: Our results show that clots formed ex vivo with clinically relevant doses of FC (0.9 mg/mL) display similar structural and degradation characteristics compared to the in vivo transfusion of cryoprecipitate. These findings suggest that FC is effective in restoring structural fibrin clot properties after CPB. Future studies after the administration of FC in vivo are needed to validate this hypothesis.

Medical education for African American communities in the rural South: A focus group approach to identify fundamental considerations.

PURPOSE: We sought to understand concerns fundamental to planning medical education specific to rural southern African Americans who are virtually nonexistent in American medical schools. METHODS: A diverse multidisciplinary research team conducted this qualitative study with 3 focus groups, including 17 rural medical educators recruited nationwide, 10 African American alumni of a rural medical education pipeline in Alabama, and 5 community and institutional associates of this pipeline. Analysis of recorded transcripts generated themes fitting an ecological model suggesting concerns and intervention foci at individual, community, and institutional levels. FINDINGS: Three major themes operating at all ecological levels were: (1) How "rural minority student" is defined, with "rural" often supplanting race to indicate minority status; (2) Multiple factors relate to rural racial minority student recruitment and success, including personal relationships with peers, mentors, and role models and supportive institutional policies and culturally competent faculty; and (3) Challenges to recruitment and retention of rural minority students, especially financial concerns and preparation for medical education. CONCLUSIONS: Our findings suggest that individuals, communities, and institutions provide intervention points for planning medical education specific to southern rural African Americans. These spheres of influence project a need for partnership among communities and rural medical educators to affect broad programmatic and policy changes that address the dire shortage of rural African American health professionals to help ameliorate health inequities experienced in their home communities. It is likely that linear thinking and programming will be replaced by integrated, intertwined conceptualizations to reach this goal.

Corrigendum re "Impact of Body Mass Index on Survival Outcomes for Patients with Metastatic Renal Cell Carcinoma in the Immuno-oncology Era: A Systematic Review and Meta-analysis" [Eur Urol Open Sci 2022;39:62-71].

[This corrects the article DOI: 10.1016/j.euros.2022.03.002.].

Impact of conditional cash transfer programmes on antenatal care service uptake in low and middle-income countries: a systematic review.

OBJECTIVE: Antenatal care (ANC) is crucial to protecting the health of pregnant women and their unborn children; however, the uptake of ANC among pregnant women in low and middle-income countries (LMICs) is suboptimal. One popular strategy to increase the uptake of health services, including ANC visits, are conditional cash transfer (CCT) programmes. CCT programmes require beneficiaries to comply with certain conditionalities in order to receive a financial sum. A systematic review was carried out to determine whether CCT programmes have a positive impact on ANC uptake in LMIC populations. METHODS: Electronic databases CENTRAL, MEDLINE, Embase, Maternity and Infant Care and Global Health were searched from database inception to 21 January 2022. Reference checking and grey literature searches were also applied. Eligible study designs were randomised controlled trials, controlled before-after studies and interrupted time series analysis. Risk of bias assessments were undertaken for each study by applying the Risk of Bias 2 tool and the Risk of Bias in Non-randomised Studies of Interventions tool. RESULTS: Out of 1534 screened articles, 18 publications were included for analysis. Eight studies reported statistically non-significant results on all reported outcomes. Seven studies demonstrated statistically significant positive effects ranging from 5.5% to 45% increase in ANC service uptake. A further three studies reported small but statistically significant impact of CCT on the use of ANC services in both positive (2.5% increase) and negative (3.7% decrease) directions. Subanalysis of results disaggregated by socioeconomic status (SES) indicated that ANC attendance may be more markedly improved by CCT programmes in low SES populations; however, results were inconclusive. CONCLUSION: Our evidence synthesis presented here demonstrated a highly heterogeneous evidence base pertaining to the impact of CCTs on ANC attendance. More high-powered studies are required to elucidate the true impact of CCT programmes on ANC uptake, with particular focus on the barriers and enablers of such programmes in achieving intended outcomes.

Increasing Uptake of Prescription Drug Take-Back Boxes: Eliciting Preferences and Applying the Theory of Planned Behavior to Predict Use.

This study assesses adults' perceptions of and predictors of intention to use prescription drug take-back boxes. This mixed methods study utilized focus groups and an online survey to examine factors related to intention to use a prescription drug take-back box. This study was conducted in [State] during the spring and summer of 2018. Themes identified in focus group data included the importance of take-back box location, benefits of take-back box use (such as reducing opportunities for medication misuse), and barriers to take-back box use (such as lack of awareness, stigma associated with law enforcement). Survey results indicate that pharmacies are the most preferred take-back box location and that attitudes, subjective norms, and perceived behavioral control are statistically significant predictors of intention to use a take-back box. Results suggest that individuals are open to using take-back boxes in secure, convenient locations, but many are unaware of take-back boxes as an option for safe disposal. These findings have implications for health communication and policy efforts designed to increase the use of take-back boxes for prescription drug disposal.

An analysis of government-sponsored health insurance enrolment and claims data from Meghalaya: Insights into the provision of health care in North East India.

INTRODUCTION: The Megha Health Insurance Scheme (MHIS) was launched in 2013 in the North-East Indian state of Meghalaya to reduce household out-of-pocket expenditure on health and provide access to high-quality essential healthcare. Despite substantial expansion of the MHIS since the scheme's inception, there is a lack of comprehensive documentation and evaluation of the scheme's performance against its Universal Health Care (UHC) objectives. METHODS: We analysed six years of enrolment and claims data (2013-2018) covering three phases of the scheme to understand the pattern of enrolment, utilisation and care provision under the MHIS during this period. De-identified data files included information on age, sex, district of residence, the district of provider hospital, type of hospital, date of admission, status at discharge, claimed category of care, package codes, and amount claimed. Descriptive statistics were generated to investigate key trends in enrolment, service utilisation, and Government health spending under the MHIS. RESULTS: Approximately 55% of the eligible population are currently enrolled in MHIS. Enrolment increased consistently from phase I through III and remained broadly stable across districts, gender, age group and occupation categories, with a small decline in males 19-60 years. Claims were disproportionately skewed towards private provision; 57% of all claims accrued to the 18 empanelled private hospitals and 39% to the 159 public sector facilities. The package 'General Ward Unspecified' was responsible for the highest volume of claims and highest financial dispensation across all three phases of the scheme. This likely indicates substantial administrative error and is potentially masking both true burden of disease and accurate financial provision for care under the MHIS. Anti-rabies injections for dog/cat bite contributed to 11% of total claims under MHIS III, and 1.6% of all claims under MHIS II. This warrants investigation to better understand the burden of animal bites on the Meghalayan population and inform the implementation of cost-effective strategies to reduce this burden. CONCLUSIONS: This paper describes the first analysis of health insurance enrolment and claims data in the state of Meghalaya. The analysis has generated an important evidence base to inform future MHIS enrolment and care provision policies as the scheme expands to provide Universal Health Coverage to the state's entire population.

The impact of COVID-19 on essential health service provision for noncommunicable diseases in the South-East Asia region: A systematic review.

Background: COVID-19 has had a profound impact on the health systems of the 11 countries of the WHO South East Asia Region. We conducted a systematic review of studies that used quantitative and comparative approaches to assess the impact of the pandemic on the service provision of four noncommunicable diseases (NCDs) (cancer, cardiovascular disease, chronic respiratory diseases, and diabetes) in the region. Methods: A systematic search was conducted in PubMed, Embase, MedRxiv, and WHO COVID-19 databases in December 2021. The quality of studies was evaluated using the Joanna Briggs Institute Critical Appraisal Checklist and the ROBINS-I risk of bias tool. A narrative synthesis was conducted following the 'synthesis without meta-analysis' reporting guidelines. Findings: Two review authors independently screened 5,397 records with 31 studies included, 26 which were cross-sectional studies. Most studies (n=24, 77%) were conducted in India and 19 (61%) were single-site studies. Compared to a pre-pandemic period, 10/17 cancer studies found a >40% reduction in outpatient services, 9/14 cardiovascular disease found a reduction of 30% or greater in inpatient admissions and 2 studies found diagnoses and interventions for respiratory diseases reduced up to 78.9% and 83.0%, respectively. No eligible studies on the impact of COVID-19 on diabetes services were found. Interpretation: COVID-19 has substantially disrupted the provision of essential health services for NCDs in the WHO South East Asia Region, particularly cancer and cardiovascular disease. This is likely to have serious and potentially long-term downstream impacts on health and mortality of those living with or at risk of NCDs in the region. Funding: This work was supported by the WHO Sri Lanka Country Office.