The impact of a multi-faceted intervention on non-prescription dispensing of antibiotics by urban community pharmacies in Indonesia: a mixed methods evaluation.

INTRODUCTION: Non-prescription antibiotic dispensing is prevalent among community pharmacies in several low- and middle-income countries. We evaluated the impact of a multi-faceted intervention to address this challenge in urban community pharmacies in Indonesia. METHODS: A pre-post quasi-experimental study was carried out in Semarang city from January to August 2022 to evaluate a 7-month long intervention comprising: (1) online educational sessions for pharmacists; (2) awareness campaign targeting customers; (3) peer visits; and (4) pharmacy branding and pharmacist certification. All community pharmacies were invited to take part with consenting pharmacies assigned to the participating group and all remaining pharmacies to the non-participating group. The primary outcome (rate of non-prescription antibiotic dispensing) was measured by standardised patients displaying symptoms of upper respiratory tract infection, urinary tract infection (UTI) and seeking care for diarrhoea in a child. χ2 tests and multivariate random-effects logistic regression models were conducted. Thirty in-depth interviews were conducted with pharmacists, staff and owners as well as other relevant stakeholders to understand any persistent barriers to prescription-based dispensing of antibiotics. FINDINGS: Eighty pharmacies participated in the study. Postintervention, non-prescription antibiotics were dispensed in 133/240 (55.4%) consultations in the participating group compared with 469/570 (82.3%) in the non-participating group (p value <0.001). The pre-post difference in the non-prescription antibiotic dispensing rate in the participating group was 20.9% (76.3%-55.4%) compared with 2.3% (84.6%-82.3%) in the non-participating group (p value <0.001).Non-prescription antibiotics were less likely to be dispensed in the participating group (OR=0.19 (95% CI 0.09 to 0.43)) and more likely to be dispensed for the UTI scenario (OR=3.29 (95% CI 1.56 to 6.94)). Barriers to prescription-based antibiotic dispensing included fear of losing customers, customer demand, and no supervising pharmacist present. INTERPRETATION: Multifaceted interventions targeting community pharmacies can substantially reduce non-prescription antibiotic dispensing. Future studies to evaluate the implementation and sustainability of this intervention on a larger scale are needed.

Socioeconomic determinants of very frequent presentations to emergency departments in New South Wales, Australia: A state wide data linkage study.

Objectives: To describe the clinical and longitudinal patterns of presentation, and to understand the underlying socioeconomic characteristics of different modes of presentation. Design: Retrospective state-wide data linkage analysis of emergency department (ED) presentations. Patients were included if they were 18 years of age or over and presented to the ED over twenty times within any consecutive 365-day period between January 2015 and December 2020. This analysis used routinely collected data from the Emergency Department Data Collection and Admitted Patient Data Collection. The quintile of Socioeconomic Indexes for Area (SEIFA) defined by Australian Bureau of Statistics was used for equity considerations. Main outcome measures: The main outcomes of interest included patients' clinical presentation, demographic information and SEIFA score as represented by Index of Relative Socioeconomic Advantage and Disadvantage (IRSAD) quintiles. Results: There were 417,154 presentations and 5,244 patients who met the inclusion criteria. The majority of the presentations were from SEIFA groups 1 (28.2 %) and 2 (35.6 %). The most common presentations were for drug and alcohol (17.5 %), followed by abdominal pathology (11.8 %) and mental health (11.5 %). In the lowest SEIFA group, the main presenting complaints were for drug and alcohol and administrative presentations. While in the highest SEIFA group, the main presentations were for mental health then abdominal pain, followed by drug and alcohol presentations. Conclusion: Patients in the lower SEIFA groups tended to be older with lower acuity presentations and were more likely to present to the same facility, more regularly. Patients in the lower SEIFA group were also more likely to present with drug and alcohol and administrative presentations while those in the higher SEIFA groups were more likely to present with mental health presentations. System wide interventions are needed to address the needs of both groups, particularly those from lower socioeconomic backgrounds, who would benefit from improved access to primary care either through access to General Practice or Urgent Care Centres.

The gender gap in outpatient care for non-communicable diseases in Mexico between 2006 and 2022.

BACKGROUND: Equitable health service utilization is key to health systems' optimal performance and universal health coverage. The evidence shows that men and women use health services differently. However, current analyses have failed to explore these differences in depth and investigate how such gender disparities vary by service type. This study examined the gender gap in the use of outpatient health services by Mexican adults with non-communicable diseases (NCDs) from 2006 to 2022. METHODS: A cross-sectional population-based analysis of data drawn from National Health and Nutrition Surveys of 2006, 2011-12, 2020, 2021, and 2022 was performed. Information was gathered from 300,878 Mexican adults aged 20 years and older who either had some form of public health insurance or were uninsured. We assessed the use of outpatient health services provided by qualified personnel for adults who reported having experienced an NCD and seeking outpatient care in the 2 weeks before the survey. Outpatient service utilization was disaggregated into four categories: non-use, use of public health services from providers not corresponding to the user's health insurance, use of public health services from providers not corresponding to the user's health insurance, and use of private services. This study reported the mean percentages (with 95% confidence intervals [95% CIs]) for each sociodemographic covariate associated with service utilization, disaggregated by gender. The percentages were reported for each survey year, the entire study period, the types of service use, and the reasons for non-use, according to the type of health problem. The gender gap in health service utilization was calculated using predictive margins by gender, type of disease, and survey year, and adjusted through a multinomial logistic regression model. RESULTS: Overall, we found that women were less likely to fall within the "non-use" category than men during the entire study period (21.8% vs. 27.8%, P < 0.001). However, when taking into account the estimated gender gap measured by incremental probability and comparing health needs caused by NCDs against other conditions, compared with women, men had a 7.4% lower incremental likelihood of falling within the non-use category (P < 0.001), were 10.8% more likely to use services from providers corresponding to their health insurance (P < 0.001), and showed a 12% lower incremental probability of using private services (P < 0.001). Except for the gap in private service utilization, which tended to shrink, the others remained stable throughout the period analyzed. CONCLUSION: Over 16 years of outpatient service utilization by Mexican adults requiring care for NCDs has been characterized by the existence of gender inequalities. Women are more likely either not to receive care or resort to using private outpatient services, often resulting in catastrophic out-of-pocket expenses for them and their families. Such inequalities are exacerbated by the segmented structure of the Mexican health system, which provides health insurance conditional on formal employment participation. These findings should be considered as a key factor in reorienting NCD health policies and programs from a gender perspective.

A Qualitative Study of Aboriginal Peoples' Health Care Experiences With Chronic Obstructive Pulmonary Disease.

Aboriginal Australians experience a high prevalence of chronic obstructive pulmonary disease (COPD), with high rates of potentially preventable hospitalisations. However, little is known about Aboriginal peoples' experiences of living with COPD and how they navigate health care systems. This study used thematic analysis and Aboriginal methodology to explore Aboriginal peoples' lived experiences of COPD, their health care journey from receiving a diagnosis of COPD to the clinical management, and the impact of COPD on their daily lives. We conducted in-depth semi-structured interviews over a 6-month period with 18 Aboriginal adults diagnosed with COPD from four Aboriginal Community Controlled Health Services (ACCHS) in New South Wales, Australia. Reflexive thematic analysis was employed to ensure rigour. The findings revealed deeply personal and reflective stories shaped by historical, social, and cultural realities of Aboriginal peoples living with COPD. Four themes were identified characterising their experiences. Based on the findings, the following guidance is provided on future COPD care for Aboriginal peoples: Better alignment of existing COPD management with Aboriginal peoples' cultural contexts and perspectives to improve access to culturally safe care; Increased funding for ACCHS to enhance COPD management, such as early detection through case finding and access to ACCHS-led pulmonary rehabilitation; Engaging family members in COPD management and providing culturally centred COPD education that facilitates discussions and builds health literacy and self-management skills; Implementing health promotion initiatives to increase awareness and counteract fear and shame to improve early COPD detection.

The costs, health and economic impact of air pollution control strategies: a systematic review.

BACKGROUND: Air pollution poses a significant threat to global public health. While broad mitigation policies exist, an understanding of the economic consequences, both in terms of health benefits and mitigation costs, remains lacking. This study systematically reviewed the existing economic implications of air pollution control strategies worldwide. METHODS: A predefined search strategy, without limitations on region or study design, was employed to search the PubMed, Scopus, Cochrane Library, Embase, Web of Science, and CEA registry databases for studies from their inception to November 2023 using keywords such as "cost-benefit analyses", "air pollution", and "particulate matter". Focus was placed on studies that specifically considered the health benefits of air pollution control strategies. The evidence was summarized by pollution control strategy and reported using principle economic evaluation measurements such as net benefits and benefit-cost ratios. RESULTS: The search yielded 104 studies that met the inclusion criteria. A total of 75, 21, and 8 studies assessed the costs and benefits of outdoor, indoor, and mixed control strategies, respectively, of which 54, 15, and 3 reported that the benefits of the control strategy exceeded the mitigation costs. Source reduction (n = 42) and end-of-pipe treatments (n = 15) were the most commonly employed pollution control methodologies. The association between particulate matter (PM) and mortality was the most widely assessed exposure-effect relationship and had the largest health gains (n = 42). A total of 32 studies employed a broader benefits framework, examining the impacts of air pollution control strategies on the environment, ecology, and society. Of these, 31 studies reported partially or entirely positive economic evidence. However, despite overwhelming evidence in support of these strategies, the studies also highlighted some policy flaws concerning equity, optimization, and uncertainty characterization. CONCLUSIONS: Nearly 70% of the reviewed studies reported that the economic benefits of implementing air pollution control strategies outweighed the relative costs. This was primarily due to the improved mortality and morbidity rates associated with lowering PM levels. In addition to health benefits, air pollution control strategies were also associated with other environmental and social benefits, strengthening the economic case for implementation. However, future air pollution control strategy designs will need to address some of the existing policy limitations.

The cost-effectiveness of a co-managed care model for elderly hip fracture patients in China: a modelling study.

Background: The clinical effectiveness of multidisciplinary co-managed care for hip fracture patients in China has been demonstrated in a multicenter non-randomized controlled study. This study aims to estimate the cost-effectiveness of the co-managed care. Methods: The study is based on a multicenter clinical trial (n = 2071) in China. We developed a state transition microsimulation model to estimate the cost-effectiveness of the co-managed care compared with usual care for hip fracture patients from healthcare system perspective. The costs incorporated into the model included hospitalization costs, post-discharge expenses, and secondary fracture therapy costs. Effectiveness was measured using quality-adjusted life years (QALYs). Costs and effects were discounted at 5% annually. A simulation cycle length of 1-year and a lifetime horizon were employed. The cost-effectiveness threshold was established at USD 37,118. To address uncertainties, one-way deterministic sensitivity analysis and probabilistic sensitivity analysis were conducted. Findings: In the base case analysis, the co-managed care group had a lifetime cost of USD 31,571 and achieved an effectiveness of 3.22 QALYs, whereas the usual care group incurred a cost of USD 27,878 and gained 2.85 QALYs. The incremental cost-effectiveness ratio was USD 9981 per QALY gained; thus the co-managed care model was cost-effective. The cost-effectiveness was sensitive to the age of having hip fractures and hospitalization costs in the intervention group. Interpretation: The co-managed care in hip fracture patients represents value for money, and should be scaled up and prioritized for funding in China. Funding: The study is supported by Capital's Funds for Health Improvement and Research (2022-1-2071, 2018-1-2071).

Improving the management of type 2 diabetes in China using a multifaceted digital health intervention in primary health care: the SMARTDiabetes cluster randomised controlled trial.

Background: There is limited evidence, mainly from high-income countries, that digital health interventions improve type 2 diabetes (T2DM) care. Large-scale implementation studies are lacking. Methods: A multifaceted digital health intervention comprising: (1) a self-management application ('app') for patients and lay 'family health promotors' (FHPs); and (2) clinical decision support for primary care doctors was evaluated in an open-label, parallel, cluster randomized controlled trial in 80 communities (serviced by a primary care facility for >1000 residents) in Hebei Province, China. People >40 years with T2DM and a glycated haemoglobin (HbA1c) ≥7% were recruited (∼25/community). After baseline assessment, community clusters were randomly assigned to intervention or control groups (1:1) via a web-based system, stratified by locality (rural/urban). Control arm clusters received usual care without access to the digital health application or family health promoters. The primary outcome was at the participant level defined as the proportion with ≥2 "ABC" risk factor targets achieved (HbA1c < 7.0%, blood pressure < 140/80 mmHg and LDL-cholesterol < 2.6 mmol/L) at 24 months. Findings: A total of 2072 people were recruited from the 80 community clusters (40 urban and 40 rural), with 1872 (90.3%) assessed at 24 months. In the intervention arm, patients used FHPs for support more in rural than urban communities (252 (48.6%) rural vs 92 (21.5%) urban, p < 0.0001). The mean monthly proportion of active app users was 46.4% (SD 7.8%) with no significant difference between urban and rural usage rates. The intervention was associated with improved ABC control rates (339 [35.9%] intervention vs 276 [29.9%] usual care; RR 1.20, 95% CI 1.02-1.40; p = 0.025), with significant heterogeneity by geography (rural 220 [42.6%] vs 158 [31.0%]; urban 119 [27.9%] vs 118 [28.6%]; p = 0.022 for interaction). Risk factor reductions were mainly driven by improved glycaemic control (mean HbA1C difference -0.33%, 95% CI -0.48 to -0.17; p = 0.00025 and mean fasting plasma glucose difference -0.58 mmol, 95% CI -0.89 to -0.27; p = 0.00013). There were no changes in blood pressure and LDL-cholesterol levels. Interpretation: A multifaceted digital health intervention improved T2DM risk factor control rates, particularly in rural communities where there may be stronger relationships between patients and doctors and greater family member support. Funding: National Health and Medical Research CouncilGlobal Alliance for Chronic Diseases (ID 1094712).

Process evaluation of a data-driven quality improvement program within a cluster randomised controlled trial to improve coronary heart disease management in Australian primary care.

BACKGROUND: This study evaluates primary care practices' engagement with various features of a quality improvement (QI) intervention for patients with coronary heart disease (CHD) in four Australian states. METHODS: Twenty-seven practices participated in the QI intervention from November 2019 -November 2020. A combination of surveys, semi-structured interviews and other materials within the QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease (QUEL) study were used in the process evaluation. Data were summarised using descriptive statistical and thematic analyses for 26 practices. RESULTS: Sixty-four practice team members and Primary Health Networks staff provided feedback, and nine of the 63 participants participated in the interviews. Seventy-eight percent (40/54) were either general practitioners or practice managers. Although 69% of the practices self-reported improvement in their management of heart disease, engagement with the intervention varied. Forty-two percent (11/26) of the practices attended five or more learning workshops, 69% (18/26) used Plan-Do-Study-Act cycles, and the median (Interquartile intervals) visits per practice to the online SharePoint site were 170 (146-252) visits. Qualitative data identified learning workshops and monthly feedback reports as the key features of the intervention. CONCLUSION: Practice engagement in a multi-featured data-driven QI intervention was common, with learning workshops and monthly feedback reports identified as the most useful features. A better understanding of these features will help influence future implementation of similar interventions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134.

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.

Implementation of low-intensity thrombolysis monitoring care in routine practice: process evaluation of the Optimal Post rtPA-IV Monitoring in Acute Ischemic Stroke (OPTIMISTmain) study in the United States.

INTRODUCTION: The ongoing OPTIMISTmain study, an international, multicenter, stepped-wedge cluster randomized trial, aims to determine effectiveness and safety of low-intensity versus standard monitoring in thrombolysis-treated patients with mild-to-moderate acute ischemic stroke (AIS). An embedded process evaluation explored integration and impact of the intervention on care processes at participating US sites. METHODS: A mixed-methods approach with quantitative and qualitative data were collected between September 2021 and November 2022. Implementer surveys were undertaken at pre- and post-intervention phases to understand the perceptions of low-intensity monitoring strategy. A sample of stroke care nurses were invited to participate in semi-structured interviews at an early stage of post-intervention. Qualitative data were analyzed deductively using the normalization process theory; quantitative data were tabulated. RESULTS: Interviews with 21 nurses at 8 hospitals have shown low-intensity monitoring was well accepted, as there were less time constraints and reduced workload for each patient. There were initial safety concerns over missing deteriorating patients and difficulties in changing established routines. Proper training, education, and communication, and changing the habits and culture of care, were key elements to successfully adopting the new monitoring care into routine practice. Similar results were found in the post-intervention survey (42 nurses from 13 hospitals). Nurses reported time being freed up to provide patient education (56%), daily living care (50%), early mobilization (26%), mood/cognition assessment (44%), and other aspects (i.e. communication, family support). CONCLUSIONS: Low-intensity monitoring for patients with mild-to-moderate acute ischemic stroke, facilitated by appropriate education and organizational support, appears feasible and acceptable at US hospitals.

Utilisation of Chronic Disease and Mental Health Management Services and Cardioprotective Medication Prescriptions in Primary Care for Patients With Cardiovascular Diseases and Cancer: A Cross-Sectional Study.

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality among cancer survivors. Mental health is considered an important risk factor affecting the treatment of cardiovascular disease. However, little is known about the use of secondary prevention strategies for CVD in patients with both cancer and CVD. This study aimed to compare the utilisation of primary care chronic disease management plans, mental health care and guideline-indicated cardioprotective medications among CVD patients with and without cancer. METHODS: Retrospective cross-sectional study utilising clinical data of patients with CVD from 50 Australian primary care practices. Outcomes included the use of chronic disease management plans, mental health care, guideline-indicated cardioprotective medications and influenza vaccination. Logistic regression, accounting for demographic and clinical covariates and clustering effects by practices, was used to compare the two groups. RESULTS: Of the 15,040 patients with CVD, 1,486 patients (9.9%) concurrently had cancer. Patients with cancer, compared to those without, were older (77.6 vs 71.8 years, p<0.001), more likely to drink alcohol (62.6% vs 55.7%, p<0.001), have lower systolic (130.3±17.8 vs 132.5±21.1 mmHg, p<0.001) and diastolic (72.2±11 vs 75.3±34 mmHg, p<0.001) blood pressure. Although suboptimal for both groups, patients with cancer were significantly more likely to have general practice management plans (GPMPs) (51.4% vs 43.2%, p<0.001), coordination of team care arrangements (TCAs) (46.2% vs 37.0%, p<0.001), have a review of either GPMP or TCA (42.8% vs 34.7%, p<0.001), have a mental health treatment consultation (15.4% vs 10.5%, p=0.004) and be prescribed blood pressure-lowering medications (70.1% vs 66.0%, p=0.002). However, there were no statistical differences in the prescription of lipid-lowering or antiplatelet medications. After adjustments for covariates and multiple testing, patients with cancer did not show a difference in GPMPs, TCAs, and a review of either, but were more likely to receive mental health treatment consultations than those without cancer (odds ratio 1.76; 95% confidence interval 1.42-2.19). CONCLUSIONS: Less than half of patients with CVD had a GPMP, TCA or review of either. Although those patients with cancer were more likely to receive these interventions, still around half the patients did not. Medicare-funded GPMPs, TCAs and a review of either GPMP or TCA were underutilised, and future studies should seek to identify ways of improving access to these services.

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.

Legal and regulatory instruments for NCD prevention: a scoping review and descriptive analysis of evaluations in OECD countries.

CONTEXT: Public health law is an important tool in non-communicable disease (NCD) prevention. There are different approaches available for achieving policy objectives, including government, co-, quasi- and self-regulation. However, it is often unclear what legal design features drive successes or failures in particular contexts. This scoping review undertakes a descriptive analysis, exploring the design characteristics of legal instruments that have been used for NCD prevention and implemented and evaluated in OECD countries. METHODS: A scoping review was conducted across four health and legal databases (Scopus, EMBASE, MEDLINE, HeinOnline), identifying study characteristics, legal characteristics and regulatory approaches, and reported outcomes. Included studies focused on regulation of tobacco, alcohol, unhealthy foods and beverages, and environmental pollutants. FINDINGS: We identified 111 relevant studies evaluating 126 legal instruments. Evaluation measures most commonly assessed implementation, compliance and changes to the built and lived environment. Few studies evaluated health or economic outcomes. When examining the design and governance mechanisms of the included legal instruments, government regulation was most commonly evaluated (n = 90) and most likely to be reported effective (64%). Self-regulation (n = 27) and quasi-regulation (n = 5) were almost always reported to be ineffective (93% and 100% respectively). There were few co-regulated instruments evaluated (n = 4) with mixed effectiveness. When examining public health risks, food and beverages including alcohol were more likely to be self- or quasi-regulated and reported as ineffective more often. In comparison, tobacco and environmental pollutants were more likely to have government mandated regulation. Many evaluations lacked critical information on regulatory design. Monitoring and enforcement of regulations was inconsistently reported, making it difficult to draw linkages to outcomes and reported effectiveness. CONCLUSIONS: Food and alcohol regulation has tended to be less successful in part due to the strong reliance on self- and quasi-regulation. More work should be done in understanding how government regulation can be extended to these areas. Public health law evaluations are important for supporting government decision-making but must provide more detail of the design and implementation features of the instruments being evaluated - critical information for policy-makers.

POLICY POINTS: Government regulation is reported as more effective than co-regulation, quasi-regulation or self-regulation. Voluntary approaches, including voluntary government regulation, are reported less effective due to low uptake and limited accountability. In public health law mandated government regulation should be strived for.Food and alcohol sectors are more likely to adopt self- or quasi-regulation and are frequently reported as ineffective. More work should be done to support government regulation in these areas.Many public health law evaluations are lacking critical design information for policy makers. This may make it difficult to learn from successes or failures and replicate interventions in other jurisdictions.

Cost-Effectiveness of Salt Substitute and Salt Supply Restriction in Eldercare Facilities: The DECIDE-Salt Cluster Randomized Clinical Trial.

Importance: Salt substitution has been reported to be a cost-saving sodium reduction strategy that has not yet been replicated in different contexts. Objective: To estimate the cost-effectiveness of sodium reduction strategies within the DECIDE-Salt trial. Design, Setting, and Participants: The DECIDE-Salt trial cluster randomized in a 1:1:1:1 ratio 48 eldercare facilities in China into 4 groups for evaluation of 2 sodium reduction strategies for 2 years: 1 with both strategies, 2 with either strategy, and 1 with neither strategy. The trial was conducted from September 25, 2017, through October 24, 2020. Interventions: The 2 intervention strategies were replacing regular salt with salt substitute and progressively restricting salt supply to kitchens. Main Outcomes and Measures: The main outcomes included per-participant costs of intervention implementation and medical treatments for hypertension and major adverse cardiovascular events (MACEs) against mean reductions in systolic blood pressure, hypertension prevalence, MACE incidence, and mortality. The incremental cost-utility ratio was then assessed as the additional mean cost per quality-adjusted life-year gained. Analyses were conducted separately for each strategy, comparing groups assigned and not assigned the test strategy. Disease outcomes followed the intention-to-treat principle and adopted different models as appropriate. One-way and probabilistic sensitivity analyses were conducted to explore uncertainty, and data analyses were performed between August 13, 2022, and April 5, 2023. Results: A total of 1612 participants (1230 males [76.3%]) with a mean (SD) age of 71.0 (9.5) years were enrolled. Replacing regular salt with salt substitute reduced mean systolic blood pressure by 7.14 (95% CI, 3.79-10.48) mm Hg, hypertension prevalence by 5.09 (95% CI, 0.37-9.80) percentage points, and cumulative MACEs by 2.27 (95% CI, 0.09-4.45) percentage points. At the end of the 2-year intervention, the mean cost was $25.95 less for the salt substitute group than the regular salt group due to substantial savings in health care costs for MACEs (mean [SD], $72.88 [$9.11] vs $111.18 [$13.90], respectively). Sensitivity analysis showed robust cost savings. By contrast, the salt restriction strategy did not show significant results. If the salt substitution strategy were rolled out to all eldercare facilities in China, 48 101 MACEs and 107 857 hypertension cases were estimated to be averted and $54 982 278 saved in the first 2 years. Conclusions and Relevance: The findings of this cluster randomized clinical trial indicate that salt substitution may be a cost-saving strategy for hypertension control and cardiovascular disease prevention for residents of eldercare facilities in China. The substantial health benefit savings in preventing MACEs and moderate operating costs offer strong evidence to support the Chinese government and other countries in planning or implementing sodium intake reduction and salt substitute campaigns. Trial Registration: ClinicalTrials.gov Identifier: NCT03290716.

Establishing cost-effectiveness threshold in China: a community survey of willingness to pay for a healthylife year.

INTRODUCTION: The willingness to pay per quality-adjusted life year gained (WTP/Q) is commonly used to determine whether an intervention is cost-effective in health technology assessment. This study aimed to evaluate the WTP/Q for different disease scenarios in a Chinese population. METHODS: The study employed a quadruple-bounded dichotomous choice contingent valuation method to estimate the WTP/Q in the general public. The estimation was conducted across chronic, terminal and rare disease scenarios. Face-to-face interviews were conducted in a Chinese general population recruited from Jiangsu province using a convenience sampling method. Interval regression analysis was performed to determine the relationship between respondents' demographic and socioeconomic conditions and WTP/Q. Sensitivity analyses of removing protest responses and open question analyses were conducted. RESULTS: A total of 896 individuals participated in the study. The WTP/Q thresholds were 128 000 Chinese renminbi (RMB) ($36 364) for chronic diseases, 149 500 RMB ($42 472) for rare diseases and 140 800 RMB ($40 000) for terminal diseases, equivalent to 1.76, 2.06 and 1.94 times the gross domestic product per capita in China, respectively. The starting bid value had a positive influence on participants' WTP/Q. Additionally, residing in an urban area (p<0.01), and higher household expenditure (p<0.01), educational attainment (p<0.02) and quality of life (p<0.02) were significantly associated with higher WTP/Q. Sensitivity analyses demonstrated the robustness of the results. CONCLUSION: This study implies that tailored or varied rather than a single cost-effectiveness threshold could better reflect community preferences for the value of a healthy year. Our estimates hold significance in informing reimbursement decision-making in health technology assessment in China.

Uptake of mandated pregnancy warnings in the Australian alcoholic ready-to-drink beverage market.

INTRODUCTION: A mandatory pregnancy warning was introduced in Australia 2020 to advise the public of the potential harms of prenatal alcohol exposure. Due to industry pressure, a 3-year implementation period was granted. The aim of this study was to analyse the extent to which the mandatory warning had been applied to ready-to-drink (RTD) alcohol product labels almost 2 years into the implementation period. METHODS: The sample included 491 RTD products sold in three alcohol stores in Sydney, Australia in March-May 2022. Identified warnings were categorised as a mandated warning, a DrinkWise warning (an industry-developed option) or 'Other' warning. Analyses were conducted overall and by RTD type. RESULTS: Almost all (94%) of the sampled RTD products had some form of pregnancy warning, but only 36% displayed the mandatory version. Of the non-mandatory warnings, 74% were DrinkWise warnings (42% of total sample) and 27% were 'Other' warnings (15% of total sample). There was no apparent relationship between alcohol content and likelihood of displaying a mandatory warning. DISCUSSION AND CONCLUSIONS: Two years into the three-year implementation period for the mandatory pregnancy warning, only around one-third of the assessed RTD products exhibited compliance. Uptake of the mandatory pregnancy warning appears to be slow. Continued monitoring will be required to determine whether the alcohol industry meets its obligations within and beyond the implementation period.

Factors influencing the time to ethics and governance approvals for clinical trials: a retrospective cross-sectional survey.

BACKGROUND: The findings from multi-centre trials are central to the practice of evidence-based medicine, enabling the development and implementation of new treatments. The time it takes to commence clinical trials at sites can be long, and ethics and governance approvals are key steps on the pathway to site activation. The goal of this study was to explore factors influencing the times to ethics approval, governance approval and site activation for multi-centre clinical trials. METHODS: This paper assessed the associations of trial characteristics (disease area and trial phase), site characteristics (government or private ownership, country) and characteristics of the ethics and governance processes (scope guidelines, mutual acceptance requirements and triage of projects by risk) with times to approvals and activation. Median times were compared between site initiations that were and were not exposed to each characteristic using non-parametric tests in univariable and multivariable regressions. RESULTS: There were data from 150 site activations done across 91 sites, 16 trials and 5 countries from November 2013 to November 2021. The overall median time to activation was 234 days (range 74 to 657), with ethics approval taking a median of 48 days (0 to 369) and governance approval a median of 34 days (0 to 489). Both the univariable and multivariable analyses identified associations of disease area, particularly oncology (p univariable = 0.012, p multivariable = 0.044), use of scope guidelines (p < 0.001, p = 0.020) and use of a triage process (p < 0.001, 0.043) with shorter median times for governance approval. These characteristics (all p < 0.001) plus early trial phase (p = 0.028) were also predictive of shorter median times for ethics approval in univariable analyses, but none remained predictive in multivariable models (all p > 0.054). The only factors associated with reduced overall time to site activation in both univariable and multivariable analyses were the early trial phase (p < 0.001, p = 0.013) and mutual acceptance of ethics approvals (p = 0.031, p = 0.030). INTERPRETATION: Times to ethics and governance approvals were only one third of total trial start-up time. Factors influencing times to approval and activation were somewhat inconsistent across analyses, but it seems likely that the introduction of selected governance and ethics processes can reduce approval times.

The main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): protocol for a pragmatic, stepped wedge, cluster randomized controlled trial.

Introduction Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low-risk of symptomatic intracerebral hemorrhage (sICH) and other complications. \ Methods OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically-stable adult patients with mild AIS (defined by a NIHSS <10) who do not require intensive care within 2 hours post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, US and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 minutes for 2 hours, 2 hourly (versus every 30 minutes) for 8 hours, and 4 hourly (versus every 1 hour) until 24 hours, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH and serious adverse events. Conclusion OPTIMISTmain will provide Level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS.

Incidence of catastrophic health spending in Indonesia: insights from a Household Panel Study 2018-2019.

BACKGROUND: Indonesia implemented one of the world's largest single-payer national health insurance schemes (the Jaminan Kesehatan Nasional or JKN) in 2014. This study aims to assess the incidence of catastrophic health spending (CHS) and its determinants and trends between 2018 and 2019 by which time JKN enrolment coverage exceeded 80%. METHODS: This study analysed data collected from a two-round cross-sectional household survey conducted in ten provinces of Indonesia in February-April 2018 and August-October 2019. The incidence of CHS was defined as the proportion of households with out-of-pocket (OOP) health spending exceeding 10% of household consumption expenditure. Chi-squared tests were used to compare the incidences of CHS across subgroups for each household characteristic. Logistic regression models were used to investigate factors associated with incurring CHS and the trend over time. Sensitivity analyses assessing the incidence of CHS based on a higher threshold of 25% of total household expenditure were conducted. RESULTS: The overall incidence of CHS at the 10% threshold fell from 7.9% to 2018 to 4.4% in 2019. The logistic regression models showed that households with JKN membership experienced significantly lower incidence of CHS compared to households without insurance coverage in both years. The poorest households were more likely to incur CHS compared to households in other wealth quintiles. Other predictors of incurring CHS included living in rural areas and visiting private health facilities. CONCLUSIONS: This study demonstrated that the overall incidence of CHS decreased in Indonesia between 2018 and 2019. OOP payments for health care and the risk of CHS still loom high among JKN members and among the lowest income households. More needs to be done to further contain OOP payments and further research is needed to investigate whether CHS pushes households below the poverty line.