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.

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.

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.

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.

A codesigned integrated kidney and diabetes model of care improves patient activation among patients from culturally and linguistically diverse backgrounds.

BACKGROUND: Little is known about the relationship between patients' cultural and linguistic backgrounds and patient activation, especially in people with diabetes and chronic kidney disease (CKD). We examined the association between culturally and linguistically diverse (CALD) background and patient activation and evaluated the impact of a codesigned integrated kidney and diabetes model of care on patient activation by CALD status in people with diabetes and CKD. METHODS: This longitudinal study recruited adults with diabetes and CKD (Stage 3a or worse) who attended a new diabetes and kidney disease service at a tertiary hospital. All completed the patient activation measure at baseline and after 12 months and had demographic and clinical data collected. Patients from CALD backgrounds included individuals who spoke a language other than English at home, while those from non-CALD backgrounds spoke English only as their primary language. Paired t-tests compared baseline and 12-month patient activation scores by CALD status. RESULTS: Patients from CALD backgrounds had lower activation scores (52.1 ± 17.6) compared to those from non-CALD backgrounds (58.5 ± 14.6) at baseline. Within-group comparisons showed that patient activation scores for patients from CALD backgrounds significantly improved by 7 points from baseline to 12 months follow-up (52.1 ± 17.6-59.4 ± 14.7), and no significant change was observed for those from non-CALD backgrounds (58.5 ± 14.6-58.8 ± 13.6). CONCLUSIONS: Among patients with diabetes and CKD, those from CALD backgrounds report worse activation scores. Interventions that support people from CALD backgrounds with comorbid diabetes and CKD, such as the integrated kidney and diabetes model of care, may address racial and ethnic disparities that exist in patient activation and thus improve clinical outcomes. PATIENT OR PUBLIC CONTRIBUTION: Patients, caregivers and national consumer advocacy organisations (Diabetes Australia and Kidney Health Australia) codesigned a new model of care in partnership with healthcare professionals and researchers. The development of the model of care was informed by focus groups of patients and healthcare professionals and semi-structured interviews of caregivers and healthcare professionals. Patients and caregivers also provided a rigorous evaluation of the new model of care, highlighting its strengths and weaknesses.

Early and Intensive Motor Training for people with spinal cord injuries (the SCI-MT Trial): protocol of the process evaluation.

INTRODUCTION: People with spinal cord injury receive physical rehabilitation to promote neurological recovery. Physical rehabilitation commences as soon as possible when a person is medically stable. One key component of physical rehabilitation is motor training. There is initial evidence to suggest that motor training can enhance neurological recovery if it is provided soon after injury and in a high dosage. The Early and Intensive Motor Training Trial is a pragmatic randomised controlled trial to determine whether 10 weeks of intensive motor training enhances neurological recovery for people with spinal cord injury. This pragmatic randomised controlled trial will recruit 220 participants from 15 spinal injury units in Australia, Scotland, Italy, Norway, England, Belgium and the Netherlands. This protocol paper describes the process evaluation that will run alongside the Early and Intensive Motor Training Trial. This process evaluation will help to explain the trial results and explore the potential facilitators and barriers to the possible future rollout of the trial intervention. METHODS AND ANALYSIS: The UK Medical Research Council process evaluation framework and the Implementation Research Logic Model will be used to explain the trial outcomes and inform future implementation. Key components of the context, implementation and mechanism of impact, as well as the essential elements of the intervention and outcomes, will be identified and analysed. Qualitative and quantitative data will be collected and triangulated with the results of the Early and Intensive Motor Training Trial to strengthen the findings of this process evaluation. ETHICS AND DISSEMINATION: Ethical approval for the Early and Intensive Motor Training Trial and process evaluation has been obtained from the Human Research Ethics Committee at the Northern Sydney Local Health District (New South Wales) in Australia (project identifier: 2020/ETH02540). All participants are required to provide written consent after being informed about the trial and the process evaluation. The results of this process evaluation will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trial Registry (ACTRN12621000091808); Universal Trial Number (U1111-1264-1689).

Priority setting for non-communicable disease prevention - Co-producing a regulatory agenda informing novel codes of practice in Australia.

There are a range of priority setting methods for non-communicable disease (NCDs) prevention. However, existing methods are often designed without detailed consideration of local context and political economy- critical success factors for implementation. In Australia, codes of practice under state government Public Health Acts could be used for NCD prevention. To inform the potential development of codes of practice under Public Health Acts, this study aimed to co-create a priority setting framework that accounts for local context and the prevailing regulatory agenda. A priority setting framework was co-produced by a multidisciplinary technical advisory group consisting of government representatives, public health lawyers and academic experts. It incorporated general prioritisation criteria (evidence, cost-effectiveness, equity, burden of disease) and local contextual criteria (legal compatibility, unmet-needs, political acceptability, structural and technical feasibility, community support). The framework was then applied in practice through surveys and policy dialogue workshops to discuss political economy factors. Policies were limited to nutrition, alcohol and physical activity risk factors. Through the prioritisation process, the most impactful, feasible and acceptable policies for NCD prevention via state government codes of practice were: restrictions on in-store placement of unhealthy products, enhancing data systems and capabilities for health surveillance and implementation monitoring, removal of unhealthy foods and drinks sold and supplied in public institutions, prohibition of marketing of unhealthy foods and drinks on assets controlled by government, and implementation of subsidies or grants to increase fruit and vegetable intake. The process illustrated that explicit consideration of local context, legal compatibility and the political economy had a substantial influence on the prioritised list of actions. The proposed priority setting framework is designed to be flexible and adaptable to varying contexts, can be embedded in government processes or utilised by researchers and practitioners to co-produce a regulatory agenda that is locally relevant.

Early and intensive motor training to enhance neurological recovery in people with spinal cord injury: trial protocol.

STUDY DESIGN: Protocol for a multi-centre randomised controlled trial (the SCI-MT trial). OBJECTIVES: To determine whether 10 weeks of intensive motor training enhances neurological recovery in people with recent spinal cord injury (SCI). SETTING: Fifteen spinal injury units in Australia, Scotland, England, Italy, Netherlands, Norway, and Belgium. METHODS: A pragmatic randomised controlled trial will be undertaken. Two hundred and twenty people with recent SCI (onset in the preceding 10 weeks, American Spinal Injuries Association Impairment Scale (AIS) A lesion with motor function more than three levels below the motor level on one or both sides, or an AIS C or D lesion) will be randomised to receive either usual care plus intensive motor training (12 h of motor training per week for 10 weeks) or usual care alone. The primary outcome is neurological recovery at 10 weeks, measured with the Total Motor Score from the International Standards for Neurological Classification of SCI. Secondary outcomes include global measures of motor function, ability to walk, quality of life, participants' perceptions about ability to perform self-selected goals, length of hospital stay and participants' impressions of therapeutic benefit at 10 weeks and 6 months. A cost-effectiveness study and process evaluation will be run alongside the trial. The first participant was randomised in June 2021 and the trial is due for completion in 2025. CONCLUSIONS: The findings of the SCI-MT Trial will guide recommendations about the type and dose of inpatient therapy that optimises neurological recovery in people with SCI. TRIAL REGISTRATION: ACTRN12621000091808 (1.2.2021).

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.

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

INTRODUCTION: Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19. METHODS AND ANALYSIS: We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes. ETHICS AND DISSEMINATION: The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies. TRIAL REGISTRATION: The trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037.

Do Food and Nutrition Policies in Ethiopia Support the Prevention of Non-Communicable Diseases through Population-Level Salt Reduction Measures? A Policy Content Analysis.

INTRODUCTION: Despite the importance of salt reduction to health outcomes, relevant policy adoption in Ethiopia has been slow, and dietary consumption of sodium remains relatively high. AIM: This analysis aims to understand the content and context of existing food-related policy, strategy, and guideline documents to identify gaps and potential opportunities for salt reduction in Ethiopia in the wider context of global evidence-informed best practice nutrition policy. METHODS: Policy documents relevant to food and noncommunicable diseases (NCDs), published between 2010 and December 2021, were identified through searches of government websites supplemented with experts' advice. Documentary analysis was conducted drawing on the 'policy cube' which incorporates three dimensions: (i) comprehensiveness of policy measures, which for this study included the extent to which the policy addressed the food-related WHO "Best Buys" for the prevention of NCDs; (ii) policy salience and implementation potential; and (iii) equity (including gender) and human rights orientation. RESULTS: Thirty-two policy documents were retrieved from government ministries, of which 18 were deemed eligible for inclusion. A quarter of these documents address diet-related "Best Buys" through the promotion of healthy nutrition and decreasing consumption of excess sodium, sugar, saturated fat, and trans-fats. The remainder focuses on maternal and child health and micronutrient deficiencies. All documents lack detail relating to budget, monitoring and evaluation, equity, and rights. CONCLUSIONS: This review demonstrates that the Government of Ethiopia has established policy frameworks highlighting its intention to address NCDs, but that there is an opportunity to strengthen these frameworks to improve the implementation of salt reduction programs. This includes a more holistic approach, enhanced clarification of implementation responsibilities, stipulation of budgetary allocations, and promoting a greater focus on inequities in exposure to nutrition interventions across population groups. While the analysis has identified gaps in the policy frameworks, further qualitative research is needed to understand why these gaps exist and to identify ways to fill these gaps.

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.