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Abstract Background and aims Uncertainty persists over the effects of blood pressure (BP) lowering in acute stroke. The INTEnsive ambulance-delivered blood pressure Reduction in hyper-Acute stroke Trial (INTERACT4) aims to determine efficacy and safety of hyperacute intensive BP lowering in patients with suspected acute stroke. Given concerns over the safety of this treatment in the pre-hospital setting, particularly in relation to patients with intracerebral hemorrhage, we provide an update on progress of the study and profile of participants to date. Methods INTERACT4 is an ongoing multicentre, ambulance-delivered, randomized, open-label, blinded endpoint trial of pre-hospital BP lowering in patients with suspected acute stroke and elevated BP in China. Patients are randomized via a mobile phone digital system to intensive (target systolic BP [SBP]

Introduction: The World Health Organisation (WHO) accepted the Integrated People-centred Health Services (IPCHS) framework in 2016 as an essential component for achieving universal health coverage in fragmented health systems. We aimed to examine the empirical applications of the WHO IPCHS framework to guide its use in strengthening health-service research. Methods: Academic databases and the IPCHS website were searched for relevant articles published between 2016 and July 2023. Two reviewers independently screened and extracted data on the study design, setting, IPCHS framework components, and facilitators and barriers to implementing the IPCHS strategies. Descriptive and content analyses were conducted. Results: Six studies were identified using the IPCHS framework. Studies have examined a combination of the five IPCHS strategies. All studies reported building strong primary care-based systems and coordinating care for individuals. Continued relationships and trust, co-production of health programmes, diversity of health care team, and technology were major facilitators, while low health literacy, lack of primary setting capacity and healthcare workforce were principal barriers to IPCHS implementation. Conclusion: This scoping review offers an overview of IPCHS strategies employed in healthcare research. Generally, the IPCHS framework remains underutilised in primary research. These results offer guidance for future research to support effective healthcare delivery.

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).

Objective: To assess whether inter-professional, bidirectional collaboration between general practitioners (GPs) and pharmacists has an impact on improving cardiovascular risk outcomes among patients in the primary care setting. It also aimed to understand the different types of collaborative care models used. Study design: Systematic review and Hartung-Knapp-Sidik-Jonkman random effects meta-analyses of randomised control trials (RCTs) in inter-professional bidirectional collaboration between GP and pharmacists assessing a change of patient cardiovascular risk in the primary care setting. Data sources: MEDLINE, EMBASE, Cochrane, CINAHL and International Pharmaceutical Abstracts, scanned reference lists of relevant studies, hand searched key journals and key papers until August 2021. Data synthesis: Twenty-eight RCTs were identified. Collaboration was associated with significant reductions in systolic and diastolic blood pressure (23 studies, 5,620 participants) of –6.42 mmHg (95% confidence interval (95%CI) –7.99 to –4.84) and –2.33 mmHg (95%CI –3.76 to –0.91), respectively. Changes in other cardiovascular risk factors included total cholesterol (6 studies, 1,917 participants) –0.26 mmol/L (95%CI –0.49 to –0.03); low-density lipoprotein (8 studies, 1,817 participants) –0.16 mmol/L (95%CI –0.63 to 0.32); high-density lipoprotein (7 studies, 1,525 participants) 0.02 mmol/L (95%CI –0.02 to 0.07). Reduction in haemoglobin A1c (HbA1C) (10 studies, 2,025 participants), body mass index (8 studies, 1,708 participants) and smoking cessation (1 study, 132 participants) was observed with GP-pharmacist collaboration. Meta-analysis was not conducted for these changes. Various models of collaborative care included verbal communication (via phone calls or face to face), and written communication (emails, letters). We found that co-location was associated with positive changes in cardiovascular risk factors. Conclusion: Although it is clear that collaborative care is ideal compared to usual care, greater details in the description of the collaborative model of care in studies is required for a core comprehensive evaluation of the different models of collaboration.

Uncertainties about the efficacy of influenza vaccination for populations with heart failure (HF) in preventing cardiovascular outcomes, as well as lack of effective vaccination strategies, may contribute to low vaccine coverage rate (VCR) in China and globally. We assessed the feasibility of a strategy to promote influenza vaccines in patients hospitalized with acute HF in China and to inform the design of a hybrid effectiveness-implementation cluster randomized trial to evaluate this strategy on mortality and hospital re-admission. We conducted a cluster randomized pilot trial involving 11 hospitals in Henan Province in China, with mixed-methods evaluation between December 2020 and April 2021. A process evaluation involved interviews with 51 key informants (patients, health professionals, policy makers). The intervention included education about influenza vaccination and availability of free vaccines administered prior to hospital discharge for HF patients, while usual care included attending community-based points of vaccination (PoV) for screening and vaccination. Implementation outcomes focused on reach, fidelity, adoption, and acceptability. Recruitment rates were assessed for trial feasibility. Effectiveness outcomes were influenza VCR, HF-specific rehospitalizations and mortality at 90 days. A total of 518 HF patients were recruited from 7 intervention and 4 usual care hospitals (mean of 45 participants per hospital per month). VCR was 89.9% (311/346, 86.1-92.8%) in the intervention group and 0.6% (1/172, 0.0-3.7%) in the control group. The process evaluation demonstrated reach to patients with lower socioeconomic and education status. There was good fidelity of the intervention components, with education and PoV set up processes being adapted to local hospital workflow and workforce capacity. Intervention was acceptable and adopted by patients and health professionals. However, outside of a trial setting, concerns were raised around vaccination reimbursement costs, workforce accountability and capacity. The intervention strategy appears feasible and acceptable for improving VCR in HF patients at county-level hospitals in China. Trial registration: This pilot trial is registered with the acronym PANDA II Pilot (Population Assessment of Influenza and Disease Activity) at ChiCTR.org.cn (ChiCTR2000039081).

BackgroundTo reduce excess dietary sodium consumption, Nigeria's 2019 National Multi-sectoral Action Plan (NMSAP) for the Prevention and Control of Non-communicable Diseases includes policies based on the World Health Organization SHAKE package. Priority actions and strategies include mandatory sodium limits in processed foods, advertising restrictions, mass-media campaigns, school-based interventions, and improved front-of-package labeling. We conducted a formative qualitative evaluation of stakeholders' knowledge, and potential barriers as well as effective strategies to implement these NMSAP priority actions.MethodsFrom January 2021 to February 2021, key informant interviews (n = 23) and focus group discussions (n = 5) were conducted with regulators, food producers, consumers, food retailers and restaurant managers, academia, and healthcare workers in Nigeria. Building on RE-AIM and the Consolidated Framework for Implementation Research, we conducted directed content qualitative analysis to identify anticipated implementation outcomes, barriers, and facilitators to implementation of the NMSAP sodium reduction priority actions.ResultsMost stakeholders reported high appropriateness of the NMSAP because excess dietary sodium consumption is common in Nigeria and associated with high hypertension prevalence. Participants identified multiple barriers to adoption and acceptability of implementing the priority actions (e.g., poor population knowledge on the impact of excess salt intake on health, potential profit loss, resistance to change in taste) as well as facilitators to implementation (e.g., learning from favorable existing smoking reduction and advertising strategies). Key strategies to strengthen NMSAP implementation included consumer education, mandatory and improved front-of-package labeling, legislative initiatives to establish maximum sodium content limits in foods and ingredients, strengthening regulation and enforcement of food advertising restrictions, and integrating nutrition education into school curriculum.ConclusionWe found that implementation and scale-up of the Nigeria NMSAP priority actions are feasible and will require several implementation strategies ranging from community-focused education to strengthening current and planned regulation and enforcement, and improvement of front-of-package labeling quality, consistency, and use.

Abstract Background Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of

Introduction: The Healthy Homes and Neighbourhoods (HHAN) integrated care initiative was designed to break intergenerational cycles of social and health inequalities and enhance access to and engagement with health and social services for vulnerable families in the Sydney Local Health District. We sought to unearth the initial programme theory of the HHAN initiative to inform rollout to other relevant areas. Methods: We conducted a critical realist evaluation using steps. (1) Exploring the events around the HHAN initiative development. (2) Explore consumer experiences. (3) Identifying the entities and associations characterising the HHAN initiative and related outcomes. (4) Searching for different theoretical perspectives and explanations (abduction). (5) Hypothesising the mechanisms and [context] conditions that might have activated the generation of the HHAN outcomes (retroduction). Results: We identified three central mechanisms; trust, buy-in and motivation, and understanding family dynamics operating across consumer, provider and systems levels of the HHAN initiative. Discussion: These programme theories reveal that to achieve the goals of HHAN, interpersonal dynamics, fostering buy-in and ensuring motivation of both the consumers and care workers should be sought and sustained at all levels. Conclusion: The programme theories unveil that integrated care initiatives should foster positive relationships at all levels to ensure favourable consumer outcomes.

Abstract Background The use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and practice. A recent systematic review by Liu et al. on process evaluations of complex interventions addressing non-communicable diseases found few studies in low- and middle- income countries (LMIC) because it was restricted to randomized controlled trials, primary healthcare level and non-communicable diseases. Yet, LMICs face different barriers to implement interventions in comparison to high-income countries such as limited human resources, access to health care and skills of health workers to treat chronic conditions especially at primary health care level. Therefore, understanding the challenges of interventions for non-communicable diseases and neglected tropical diseases (diseases that affect poor populations and have chronic sequelae) will be important to improve how process evaluation is designed, conducted and used in research projects in LMICs. For these reasons, in comparison to the study of Liu et al., the current study will expand the search strategy to include different study designs, languages and settings. Objective Map research using process evaluation in the areas of non-communicable diseases and neglected tropical diseases to inform the gaps in the design and conduct of this type of research in LMICs. Methods Scoping review of process evaluation studies of randomized controlled trials (RCTs) and non-RCTs of complex interventions implemented in LMICs including participants with non-communicable diseases or neglected tropical diseases and their health care providers (physicians, nurses, technicians and others) related to achieve better health for all through reforms in universal coverage, public policy, service delivery and leadership. The aspects that will be evaluated are as follows: (i) available evidence of process evaluation in the areas of non-communicable diseases and neglected tropical diseases such as frameworks and theories, (ii) methods applied to conduct process evaluations and (iii) gaps between the design of the intervention and its implementation that were identified through the process evaluation. Studies published from January 2008. Exclusion criteria are as follows: not peer reviewed articles, not a report based on empirical research, not reported in English or Spanish or Portuguese or French, reviews and non-human research. Discussion This scoping review will map the evidence of process evaluations conducted in LMICs. It will also identify the methods they used to collect and interpret data, how different theories and frameworks were used and lessons from the implementation of complex interventions. This information will allow researchers to conduct better process evaluations considering special characteristics from countries with limited human resources, scarce data available and limited access to health care.

Introduction: Sydney Local Health District (SLHD) is a local health district in the state of New South Wales in Australia responsible for providing health services to the centre and inner west of the Sydney metropolitan area. SLHD adopted, during the COVID-19 pandemic, an integrated virtual and community care approach to manage quarantine and protect the health and wellbeing of the population. Description: The case study describes the roles of the different agencies and teams in the first six months of the pandemic across four key functions of 1) rapid screening and testing; 2) reaching the community; 3) effective quarantine and ongoing care; and 4) infrastructure, pathology and staff education. Discussion: The “whole of system” approach proved to be an effective method of delivering care that reduced community anxiety, improved and created relationships between existing and new internal and external stakeholders, and changed the community and health sector’s perspective on the importance of virtual care. Conclusion: This case study describes the importance of well-integrated, decentralised and funded public health system in response to the COVID-19 pandemic.

Introduction The objective of the Comprehensive Intervention of Oral Disease for Children (CIODC) in China is to prevent dental decay for school-aged children and provide free prevention services in pilot areas beginning in 2008. It is a potentially affordable, acceptable and effective prevention strategy to use for more school-aged children in the future. There is a shortage of robust evidence regarding the cost-effectiveness, feasibility and scalability of prevention strategies for dental decay for school-aged children in China. This study aims to provide a comprehensive evaluation, including an economic evaluation and process evaluation, to better understand how and why the public health programme may be effective and economical.Methods and analysis Mixed methods will be used in this study. Cost-effectiveness analysis (CEA) will be conducted from a societal perspective, based on a modelling study over 6 years (from age 7 to 12) in terms of the incremental cost-effectiveness ratios per dental decay averted. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework informed the process evaluation. An estimated 48–80 semistructured interviews with service providers, patient parents/caregivers and decision-makers under the logic model will be used in the progress evaluation to describe the feasibility and sustainability of CIODC.Ethics and dissemination The study has all necessary ethical approvals from the Ethics Committee of Anhui Medical University (number 2021H030). All participants will provide informed consent prior to participation. Findings will be disseminated through conference presentations and scientific publications in peer-reviewed journals.

Objectives The aim of this review is to map out the use of process evaluation (PE) in complex interventions that address non-communicable diseases (NCDs) and neglected tropical diseases (NTDs) to identify gaps in the design and conduct, as well as strengths, limitations and implications, of this type of research in low- and middle-income countries (LMICs).Design Scoping review of PE studies of complex interventions implemented in LMICs. Six databases were searched focused on studies published since 2008.Data sources Embase, PubMed, EbscoHost, Web of Science (WOS), Virtual Health Library (VHL) Regional Portal and Global Index Medicus: Regional Indexes AIM (AFRO), LILACS (AMRO/PAHO), IMEMR (EMRO), IMSEAR (SEARO), WPRIM (WPRO) Global Index Regional Indexes, MEDLINE, SciELO.Eligibility criteria Studies conducted in LMICs on PEs of randomised controlled trials (RCTs) and non-RCTs published between January 2008 and January 2020. Other criteria were studies of interventions for people at risk or having physical and mental NCDs, and/or NTDs, and/or their healthcare providers and/or others related to achieve better health for these two disease groups. Studies were excluded if they were not reported in English or Spanish or Portuguese or French, not peer-reviewed articles, not empirical research and not human research.Data extraction and synthesis Data extracted to be evaluated were: available evidence in the utilisation of PE in the areas of NCDs and NTDs, including frameworks and theories used; methods applied to conduct PEs; and in a subsample, the barriers and facilitators to implement complex interventions identified through the PE. Variables were extracted and categorised. The information was synthesised through quantitative analysis by reporting frequencies and percentages. Qualitative analysis was also performed to understand facilitators and barriers presented in these studies. The implications for PEs, and how the information from the PE was used by researchers or other stakeholders were also assessed in this approach.Results 303 studies were identified, 79% were for NCDs, 12% used the label ‘PE’, 27% described a theory or framework for the PE, and 42% used mixed methods to analyse their findings. Acceptability, barriers and facilitators to implement the interventions, experiences and perceptions, and feasibility were the outcomes most frequently evaluated as part of the PEs. Barriers and facilitators themes identified were contextual factors, health system factors, human resources, attitudes and policy factors.Conclusions PEs in NCDs and NTDs are used in LMICs with a wide variety of methods. This review identified many PEs that were not labelled by the authors as such, as well as a limited application of PE-related theories and frameworks, and heterogeneous reporting of this type of study.

Introduction Community-integrated care initiatives are increasingly being used for social and health service delivery and show promising outcomes. Nevertheless, it is unclear what structures and underlining causal agents (generative mechanisms) are responsible for explaining how and why they work or not.Methods and analysis Critical realist synthesis, a theory-driven approach to reviewing and synthesising literature based on the critical realist philosophy of science, underpinned the study. Two lenses guided our evidence synthesis, the community health system and the patient-focused perspective of integrated care. The realist synthesis was conducted through the following steps: (1) concept mining and framework formulation, (2) searching for and scrutinising the evidence, (3) extracting and synthesising the evidence (4) developing the narratives from causal explanatory theories, and (5) disseminate, implement and evaluate.Results Three programme theories, each aligning with three groups of stakeholders, were unearthed. At the systems level, three bundles of mechanisms were identified, that is, (1) commitment and motivation, (2) willingness to address integrated health concerns and (3) shared vision and goals. At the provider level, five bundles of mechanisms critical to the successful implementation of integrated care initiatives were abstracted, that is, (1) shared vision and buy-in, (2) shared learning and empowerment, (3) perceived usefulness, (4) trust and perceived support and (5) perceived role recognition and appreciation. At the user level, five bundles of mechanisms were identified, that is, (1) motivation, (2) perceived interpersonal trust, (3) user-empowerment, (4) perceived accessibility to required services and (5) self-efficacy and self-determination.Conclusion We systematically captured mechanism-based explanatory models to inform practice communities on how and why community-integrated models work and under what health systems conditions.PROSPERO registration number CRD42020210442.

Introduction The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. The trial is currently being conducted across Sydney government hospitals in Australia. This process evaluation will run alongside the REFORM trial. It combines qualitative and quantitative data to help explain the trial results and determine the feasibility of rolling out supported home exercise programmes in settings similar to the REFORM trial.Methods and analysis Two theoretical frameworks underpin our process evaluation methodology: the Realist framework (context, mechanism, outcomes) considers the causal assumptions as to why a supported home exercise programme may be as good or better than face-to-face physiotherapy in terms of the context, mechanisms and outcomes of the trial. The RE-AIM framework describes the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention. These two frameworks will be broadly used to guide this process evaluation using a mixed-methods approach. For example, qualitative data will be derived from interviews with patients, healthcare professionals and stakeholders, and quantitative data will be collected to determine the cost and feasibility of providing supported home exercise programmes. These data will be analysed iteratively before the analysis of the trial results and will be triangulated with the results of the primary and secondary outcomes.Ethics and dissemination This trial will be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2018) and the Note for Good Clinical Practice (CPMP/ICH-135/95). Ethical approval was obtained on 17 March 2017 from the Northern Sydney Local Health District Human Research Ethics Committee (trial number: HREC/16HAWKE/431-RESP/16/287) with an amendment for the process evaluation approved on 4 February 2020. The results of the process evaluation will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.Trial registration number ACTRN12619000065190.

Objective. A narrative overview of regional academic research collaborations to address the increasing burden and gaps in care for patients at risk of, and who suffer from, stroke in Latin America (LA). Materials and methods. A summary of experiences and knowledge of the local situation is presented. No systematic literature review was performed. Results. The rapidly increasing burden of stroke poses immense challenges in LA, where prevention and manage­ment strategies are highly uneven and inadequate. Clinical research is increasing through various academic consortia and networks formed to overcome structural, funding and skill barriers. However, strengthening the ability to generate, analyze and interpret randomized evidence is central to further develop effective therapies and healthcare systems in LA. Conclusions. Regional networks foster the conduct of multicenter studies –particularly randomized controlled trials–, even in resource-poor regions. They also contribute to the external validity of international studies and strengthen systems of care, clinical skills, critical thinking, and international knowledge exchange.

Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associ­ated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interven­tions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.

BackgroundThe third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3) is an ongoing, international, multicenter, stepped-wedge cluster, prospective, randomized, open, blinded endpoint assessed trial evaluating the effectiveness of a quality improvement “care bundle” for the management of patients with acute spontaneous intracerebral hemorrhage (ICH) in low- and middle-income countries (LMICs). An embedded process evaluation aims to explore the uptake and implementation of the intervention, and understand the context and stakeholder perspectives, for interpreting the trial outcomes.MethodologyThe design was informed by Normalization Process Theory and the UK Medical Research Council process evaluation guidance. Mixed methods are used to evaluate the implementation outcomes of fidelity, reach, dose, acceptability, appropriateness, adoption, sustainability, and relevant contextual factors and mechanisms affecting delivery of the care bundle. Semi-structured interviews and non-participant observations are conducted with the primary implementers (physicians and nurses) and patients/carers to explore how the care bundle was integrated into routine care. Focus group discussions are conducted with investigators and project operational staff to understand challenges and possible solutions in the organization of the trial. Data from observational records, surveys, routine monitoring data, field notes and case report forms, inform contextual factors, and adoption of the intervention. Purposive sampling of sites according to pre-specified criteria is used to achieve sample representativeness.DiscussionImplementation outcomes, and relevant barriers and facilitators to integrating the care bundle into routine practice, will be reported after completion of the process evaluation. The embedded process evaluation will aid understanding of the causal mechanisms between care bundle elements and clinical outcomes within complex health systems across diverse LMIC settings.Trial RegistrationThe INTERACT3 study is registered at ClinicalTrials.gov (NCT03209258).

Introduction Integrated community healthcare Hubs may offer a ‘one stop shop’ for service users with complex health and social needs, and more efficiently use service resources. Various policy imperatives exist to implement Hub models of care, however, there is a dearth of research specifically evaluating Hubs targeted at families experiencing adversity. To contribute to building this evidence, we propose to co-design, test and evaluate integrated Hub models of care in two Australian community health services in low socioeconomic areas that serve families experiencing adversity: Wyndham Vale in Victoria and Marrickville in New South Wales.Methods and analysis This multisite convergent mixed-methods study will run over three phases to (1) develop the initial Hub programme theory through formative research; (2) test and, then, (3) refine the Hub theory using empirical data. Phase 1 involves co-design of each Hub with caregivers, community members and practitioners. Phase 2 uses caregiver and Hub practitioner surveys at baseline, and 6 and 12 months after Hub implementation, and in-depth interviews at 12 months. Two stakeholder groups will be recruited: caregivers (n=100–200 per site) and Hub practitioners (n=20–30 per site). The intervention is a co-located Hub providing health, social, legal and community services with no comparator. The primary outcomes are caregiver-reported: (i) identification of, (ii) interventions received and/or (iii) referrals received for adversity from Hub practitioners. The study also assesses child, caregiver, practitioner and system outcomes including mental health, parenting, quality of life, care experience and service linkages. Primary and secondary outcomes will be assessed by examining change in proportions/means from baseline to 6 months, from 6 to 12 months and from baseline to 12 months. Service linkages will be analysed using social network analysis. Costs of Hub implementation and a health economics analysis of unmet need will be conducted. Thematic analysis will be employed to analyse qualitative data.Ethics and dissemination Royal Children’s Hospital and Sydney Local Health District ethics committees have approved the study (HREC/62866/RCHM-2020). Participants and stakeholders will receive results through meetings, presentations and publications.Trial registration number ISRCTN55495932.

Introduction There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions.Methods and analysis We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks.Ethics and dissemination The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.

Abstract The September 2019 United Nations’ High-Level Meeting renewed political commitments to invest in universal health coverage by strengthening health systems, programmes and policies to achieve ‘health for all’. This Political Declaration is relevant to addressing the increasing global burden of non-communicable diseases, but how can evidence-based programmes and policies be meaningfully implemented and integrated into local contexts? In this Commentary, we describe how the process of contextualisation and associated tools, such as ecological frameworks, implementation research frameworks, health system indicators, effective system strengthening strategies and evidence mapping databases with priority-setting, can enhance the implementation and integration of non-communicable disease prevention and control policies and programmes. Examples across health platforms include (1) population approaches to reducing excess sodium intake, (2) fixed-dose combination therapy for cardiovascular disease prevention and control, and (3) health systems strengthening for improving the quality and safety of cardiovascular care. Contextualisation is needed to transfer evidence into locally relevant and impactful policies and programmes. The systematic and comprehensive use of contextualisation tools leverages key implementation research principles to achieve ‘health for all’.

BackgroundSalt reduction is a cost-effective, and rather challenging public health strategy for controlling chronic diseases. The AppSalt program is a school-based multi-component mobile health (mhealth) salt reduction program designed to tackle the high salt intake in China. This mixed-methods process evaluation was conducted to investigate the implementation of this program across sites, identify factors associated with the implementation, and collect evidence to optimize the intervention design for future scale-up.MethodsMixed methods were used sequentially to collect data regarding five process evaluation dimensions: fidelity, dose delivered, dose received, reach, and context. Quantitative data were collected during the intervention process. Participation rate of intervention activities was calculated and compared across cities. The quantitative data was used for the selection of representative intervention participants for the qualitative interviews. Qualitative data were collected in face-to-face semi-structured interviews with purposively selected students (n = 33), adult family members (n = 33), teachers (n = 9), heads of schools (n = 9), key informants from local health, and education departments (n = 8). Thematic analysis technique was applied to analyze the interview transcripts using NVivo. The qualitative data were triangulated with the quantitative data during the interpretation phase.ResultsThe total number of families recruited for the intervention was 1,124. The overall retention rate of the AppSalt program was 97%. The intervention was implemented to a high level of fidelity against the protocol. About 80% of intervention participants completed all the app-based salt reduction courses, with a significant difference across the three cities (Shijiazhuang: 95%; Luzhou: 73%; Yueyang: 64%). The smartphone app in this program was perceived as a feasible and engaging health education tool by most intervention participants and key stakeholders. Through the interviews with participants and key stakeholders, we identified some barriers to implementing this program at primary schools, including the left-behind children who usually live with their grandparents and have limited access of smartphones; perceived adverse effects of smartphones on children (e.g., eyesight damage); and overlooked health education curriculum at Chinese primary schools.ConclusionThis process evaluation demonstrated the feasibility and acceptability of using smartphone applications delivered through the education system to engage families in China to reduce excessive salt intake.Clinical Trial RegistrationThe AppSalt study was registered at www.chictr.org.cn, identifier: ChiCTR1800017553. The date of registration is August 3, 2018.

Introduction Influenza virus infection is known to increase the risk of cardiovascular events, especially in populations with pre-existing cardiovascular disease (CVD). Considering that influenza is vaccine preventable, international guidelines recommend high-risk populations with CVD receive an influenza vaccine every year. However, there are various classifications of recommendations and levels of evidence. Previous systematic reviews concluded uncertain evidence on influenza vaccine efficacy for preventing cardiovascular events in the general population or in populations with pre-existing CVD. Limited safety data of influenza vaccines were reported for populations with pre-existing CVD. Randomised controlled trials with larger sample sizes relative to previous studies are emerging, the findings of these trials are likely to be highly influential on summary efficacy estimates.Methods and analysis We aim to perform a living systematic review and a prospective meta-analysis to evaluate the efficacy and safety of influenza vaccines compared with no vaccines or placebo for preventing mortality or CVD events in the general population and in populations with pre-existing CVD. Any types of randomised controlled trial and observational study meeting the Population, Intervention, Comparator, Outcome and Study design criteria for the research question will be selected for inclusion. The living systematic review status will be maintained for 3 years with an update for every 6 months. Mainstream medical literature databases will be independently searched by two authors with predefined strategies. Two authors will perform the risk of bias assessment with consensus. Narrative synthesis and meta-analyses will be performed to summarise the results.Ethics and dissemination Formal ethical review is not required as this study does not involve primary data collection. We will publish results of the living systematic review and prospective meta-analysis in a peer-reviewed journal. Findings will also be presented at relevant meetings.PROSPERO registration number CRD42021222519.

BackgroundPatients hospitalized with acute coronary syndrome (ACS) or heart failure (HF) are frequently readmitted. This is the first randomized controlled trial of a mobile health intervention that combines telemonitoring and education for inpatients with ACS or HF to prevent readmission. ObjectiveThis study aims to investigate the feasibility, efficacy, and cost-effectiveness of a smartphone app–based model of care (TeleClinical Care [TCC]) in patients discharged after ACS or HF admission. MethodsIn this pilot, 2-center randomized controlled trial, TCC was applied at discharge along with usual care to intervention arm participants. Control arm participants received usual care alone. Inclusion criteria were current admission with ACS or HF, ownership of a compatible smartphone, age ≥18 years, and provision of informed consent. The primary end point was the incidence of unplanned 30-day readmissions. Secondary end points included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness, and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure, and physical activity daily plus usual care. The devices automatically transmitted recordings to the patients’ smartphones and a central server. Thresholds for blood pressure, heart rate, and weight were determined by the treating cardiologists. Readings outside these thresholds were flagged to a monitoring team, who discussed salient abnormalities with the patients’ usual care providers (cardiologists, general practitioners, or HF outreach nurses), who were responsible for further management. The app also provided educational push notifications. Participants were followed up after 6 months. ResultsOverall, 164 inpatients were randomized (TCC: 81/164, 49.4%; control: 83/164, 50.6%; mean age 61.5, SD 12.3 years; 130/164, 79.3% men; 128/164, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P=.97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 in TCC vs 41 in the control arm; P=.02), including cardiac readmissions (11 in TCC vs 25 in the control arm; P=.03), and higher rates of cardiac rehabilitation completion (20/51, 39% vs 9/49, 18%; P=.03) and medication adherence (57/76, 75% vs 37/74, 50%; P=.002). The average usability rating for the app was 4.5/5. The intervention cost Aus $6028 (US $4342.26) per cardiac readmission saved. When modeled in a mainstream clinical setting, enrollment of 237 patients was projected to have the same expenditure compared with usual care, and enrollment of 500 patients was projected to save approximately Aus $100,000 (approximately US $70,000) annually. ConclusionsTCC was feasible and safe for inpatients with either ACS or HF. The incidence of 30-day readmissions was similar; however, long-term benefits were demonstrated, including fewer readmissions over 6 months, improved medication adherence, and improved cardiac rehabilitation completion. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12618001547235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375945

BackgroundA novel smartphone app-based model of care (TeleClinical Care – TCC) for patients with acute coronary syndrome (ACS) and heart failure (HF) was evaluated in a two-site, pilot randomised control trial of 164 participants in Sydney, Australia. The program included a telemonitoring system whereby abnormal blood pressure, weight and heart rate readings were monitored by a central clinical team, who subsequently referred clinically significant alerts to the patients' usual general practitioner (GP, also known as primary care physician in the United States), HF nurse or cardiologist. While the primary endpoint, 30-day readmissions, was neutral, intervention arm participants demonstrated improvements in readmission rates over 6 months, cardiac rehabilitation (CR) completion and medication compliance. A process evaluation was designed to identify contextual factors and mechanisms that influenced the results, as well as strategies of improving site and participant recruitment and the delivery of the intervention, for a planned larger effectiveness trial of over 1,000 patients across the state of New South Wales, Australia (TCC-Cardiac).MethodsMultiple data sources were used in this mixed-methods process evaluation, including interviews with four TCC team members, three GPs and three cardiologists. CR completion rates, HF outreach service (HFOS) referrals and cardiologist follow-up appointments were audited. A patient questionnaire was also analysed for evidence of improved self-care as a hypothesised mechanism of the TCC app. An implementation research logic model was used to synthesise our findings.ResultsRates of HFOS referral (83 vs. 72%) and cardiologist follow-up (96 vs. 93%) were similarly high in the intervention and control arms, respectively. Team members were largely positive towards their orientation and training, but highlighted several implementation strategies that could be optimised for TCC-Cardiac: streamlining of the enrolment process, improving the reach of the trial by screening patients in non-cardiac wards, and ensuring team members had adequate time to recruit (>15 h per week). GPs and cardiologists viewed the intervention acceptably regarding potential benefit of closely monitoring, and responding to abnormalities for their patients, though there were concerns of the potential additional workload generated by alerts that did not merit clinical intervention. Clear delineation of which clinician (GP or cardiologist) was primarily responsible for alert management was also recommended, as well as a preference to receive regular summary data. Several patients commented on the mechanisms of improved self-management because of TCC, which could have led to the outcome of improved medication compliance.DiscussionUse of TCC was associated with several benefits, including higher patient engagement and completion rates with CR. The conduct and delivery of TCC-Cardiac will be improved by the findings of this process evaluation to optimise recruitment, and establishing the roles of GPs and cardiologists as part of the model.

Introduction: Australia has been comparatively effective in preventing the transmission of COVID-19. The Sydney Local Health District [SLHD] used a “whole of health” integrated approach to respond to the pandemic. The aim of this study was to understand for whom, how and why this response worked, to inform a sustainable system transformation. Methods: A critical realist qualitative study was conducted with 20 purposively selected key informants. Data were collected through in-depth interviews and analysed using thematic analysis guided by abduction and retroduction. The five strategies of the WHO integrated people-centred health services framework was used to guide the overall study. Results: An enabling environment of a strong governance, emergency preparedness, a committed and adaptable workforce, and a strong core infrastructure underpinned SLHD’s effective response. With a culture of embracing innovation, the district adapted virtual care to effectively quarantine people through their special health accommodation, and coordinate care across tertiary and community services. The established interagency relationships prior to the pandemic, enabled service directors to quickly integrate their services, which empowered and engaged the community [and staff], working across relevant sectors to provide care “where the people are”; reaching marginalised populations, and reducing community transmission. Discussion and Conclusion: The SLHD’s progress towards a ‘whole of health’ approach, empowered and enabled the district to effectively work within and across sectors to address the pandemic in a people-centred manner. Sustaining the contextual conditions and mechanisms, that facilitated effective integration, will be beneficial beyond the pandemic.

BackgroundRegular salt is about 100% sodium chloride. Low-sodium salts have reduced sodium chloride content, most commonly through substitution with potassium chloride. Low-sodium salts have a potential role in reducing the population's sodium intake levels and blood pressure, but their availability in the global market is unknown. ObjectiveThe aim of this study is to assess the availability, formulation, labeling, and price of low-sodium salts currently available to consumers worldwide. MethodsLow-sodium salts were identified through a systematic literature review, Google search, online shopping site searches, and inquiry of key informants. The keywords “salt substitute,” “low-sodium salt,” “potassium salt,” “mineral salt,” and “sodium reduced salt” in six official languages of the United Nations were used for the search. Information about the brand, formula, labeling, and price was extracted and analyzed. ResultsA total of 87 low-sodium salts were available in 47 out of 195 (24%) countries worldwide, including 28 high-income countries, 13 upper-middle-income countries, and 6 lower-middle-income countries. The proportion of sodium chloride varied from 0% (sodium-free) to 88% (as percent of weight; regular salt is 100% sodium chloride). Potassium chloride was the most frequent component with levels ranging from 0% to 100% (potassium chloride salt). A total of 43 (49%) low-sodium salts had labels with the potential health risks, and 33 (38%) had labels with the potential health benefits. The median price of low-sodium salts in high-income, upper-middle-income, and lower-middle-income countries was US $15.00/kg (IQR 6.4-22.5), US $2.70/kg (IQR 1.7-5.5), and US $2.90/kg (IQR 0.50-22.2), respectively. The price of low-sodium salts was between 1.1 and 14.6 times that of regular salts. ConclusionsLow-sodium salts are not widely available and are commonly more expensive than regular salts. Policies that promote the availability, affordability, and labeling of low-sodium salts should increase uptake, helping populations reduce blood pressure and prevent cardiovascular diseases. International Registered Report Identifier (IRRID)RR2-10.1111/jch.14054

Aim: To describe and reflect on an Aboriginal researcher’s experience of vicarious trauma arising from a qualitative study of Aboriginal and Torres Strait Islander women with chronic disease. Methods: In-depth semistructured interviews with thematic analysis were undertaken to explore the psychosocial factors experienced by Aboriginal and Torres Strait Islander women as they managed their chronic disease. An ‘Indigenous women’s standpoint theory’ approach was adopted to frame discussion. This approach gives strength and power to the voice of Aboriginal and Torres Strait Islander women and their diverse cultural lived experiences. The raw and often brutal realities this approach exposed had a triggering impact on the Aboriginal team member for whom these realities were familiar. Interviews were conducted with participants from four Aboriginal Medical Services from urban, rural and remote Australia. Analysis of the interviews, and reflection regarding the researcher’s experiences, occurred within the context of a multidisciplinary team. Participant selection for the interview study was purposive. Seventy-two participants were selected for this study. The duration of the study was 2 years, and it was undertaken between March and December 2014, and finalised in December 2016. Results: In exploring how Aboriginal and Torres Strait Islander women managed their own health and wellbeing, compelling stories of trauma, domestic violence and generational incarceration were shared with the researcher. Hearing and re-living some of these overwhelming experiences left her feeling isolated and distressed. These compelling stories contributed to her experience of vicarious trauma. Conclusion: When Aboriginal and Torres Strait Islander researchers conduct research in Indigenous communities, we should monitor, prepare for and provide appropriate care and support to researchers to address the potential for vicarious trauma. These considerations are paramount if we are to build the capacity of Indigenous and non-Indigenous researchers to conduct Indigenous health research.

Abstract Objective: In the context of growing financial pressures on health budgets, cost‐effective prevention strategies are needed to address the burden from non‐communicable disease in Australia. We explored how decision makers use economic evidence to inform such investment and how such evidence generated can more effectively meet the needs of end users. Methods: Thematic analysis of in‐depth interviews with 15 high level stakeholders (Treasury, state health departments and the insurance industry), supplemented by documentary analysis. Results: Types of prevention approaches and economic evidence relevant to decision makers differed by organisational perspective. Capacity building in understanding economic evaluations and research evidence that addresses the differing criteria for investment used by different organisations is needed. The task of determining investment priorities in disease prevention comes with significant challenges including ideological barriers, delayed outcome measures, and implementation uncertainties. Conclusions and Implications for public health: Promoting the greater use of economic evidence in prevention requires more work on two fronts: tailoring the methods used by economists to better match the organisational imperatives of end users; and promoting greater consideration of broader societal and health sector perspectives among end users. This will require significant infrastructure development, monitoring and evaluation, stronger national leadership and a greater emphasis on evidence coproduction.

Introduction Cardiovascular disease (CVD) remains a major cause of morbidity and premature mortality globally. Despite the availability of low-cost evidence based medicines, there is a significant treatment gap in those with established or at high risk of CVD in the primary care setting. Pharmacist-based interventions have shown to improve patient outcomes for many chronic diseases including CVD. However, there is little synthesised evidence that has examined the effects of collaborative care between general practitioners (GPs) and pharmacists on patients’ cardiovascular risk outcomes. This protocol aims to outline the methods employed in a systematic review of current literature to assess whether interprofessional collaboration between GPs and pharmacists has an impact on improving cardiovascular risk outcomes among patients in the primary care setting.Methods and analysis Randomised controlled trials (RCTs) will be identified through database searches, scanning reference lists of relevant studies, hand searching of key journals and citation searching of key papers. Two independent reviewers will screen studies against eligibility criteria and extract data using standardised forms. Databases including MEDLINE, EMBASE, Cochrane, CINAHL and International Pharmaceutical Abstracts, will be searched from the beginning of each database until October 2018. Primary outcome includes improvement in cardiovascular risk factors, such as hypertension, due to GP and pharmacist cooperation. Secondary outcome is to describe the different types of GP and pharmacist collaborative models of care. A narrative synthesis of findings will be presented. A meta-analysis will be performed if the data are homogenous.Ethics and dissemination This study does not require ethics approval. The results of the systematic review described within this protocol will be disseminated through presentations at relevant conferences and publication in a peer-reviewed journal. The methods will be used to inform future reviews.PROSPERO registration number CRD42017055259.

Objective Process evaluations (PEs) alongside randomised controlled trials of complex interventions are valuable because they address questions of for whom, how and why interventions had an impact. We synthesised the methods used in PEs of primary care interventions, and their main findings on implementation barriers and facilitators.Design Systematic review using the UK Medical Research Council guidance for PE as a guide.Data sources Academic databases (MEDLINE, SCOPUS, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, EMBASE and Global Health) were searched from 1998 until June 2018.Eligibility criteria We included PE alongside randomised controlled trials of primary care interventions which aimed to improve outcomes for patients with non-communicable diseases.Data extraction and synthesis Two independent reviewers screened and conducted the data extraction and synthesis, with a third reviewer checking a sample for quality assurance.Results 69 studies were included. There was an overall lack of consistency in how PEs were conducted and reported. The main weakness is that only 30 studies were underpinned by a clear intervention theory often facilitated by the use of existing theoretical frameworks. The main strengths were robust sampling strategies, and the triangulation of qualitative and quantitative data to understand an intervention’s mechanisms. Findings were synthesised into three key themes: (1) a fundamental mismatch between what the intervention was designed to achieve and local needs; (2) the required roles and responsibilities of key actors were often not clearly understood; and (3) the health system context—factors such as governance, financing structures and workforce—if unanticipated could adversely impact implementation.Conclusion Greater consistency is needed in the reporting and the methods of PEs, in particular greater use of theoretical frameworks to inform intervention theory. More emphasis on formative research in designing interventions is needed to align the intervention with the needs of local stakeholders, and to minimise unanticipated consequences due to context-specific barriers.PROSPERO registration number CRD42016035572.

Introduction: In March 2014, the New South Wales (NSW) Government (Australia) announced the NSW Integrated Care Strategy. The NSW Government’s Integrated Care Strategy funding enabled the establishment of an integrated care initiative called Healthy Homes and Neighbourhoods (HHAN). The Initiative was designed as a population-based, family-centered, care-coordination network that functioned across agencies to assist vulnerable families to navigate the health and social-care system, to keep themselves and their children safe, and in doing so, promote social cohesiveness. The evaluation framework is described. Methods: Since integrated care initiatives are an example of complex interventions in health and social care, we underpinned this programme of development, research and evaluation by the critical realist metatheory of science and the NSW Health Monitoring and Evaluation Framework, using the UK Medical Research Council (MRC) Framework for evaluating complex interventions.1 We adapted the iterative approach of development, feasibility/piloting, evaluation and implementation of the MRC framework to include critical realist, participatory, continuous and theory driven elements. Discussion: Both the 2008 UK Medical Research Council framework for evaluating complex interventions, and our previously reported critical realist methodology, provided the tools to enable an iterative approach to development, design, testing and continuous evaluation. The philosophical paradigms underpinning each approach are different. Both the NSW Health and MRC frameworks were developed from in the “logical positivist” inductive and deductive reasoning traditions with a strong focus on activities and outcomes but little emphasis on process. That weakness was been recognised and the MRC subsequently endorsed advice on process evaluation for complex interventions which accommodated the realist approach incorporated here. Conclusion: Integrated care initiatives are examples of complex interventions in health and social care. The interventions are multi-layered and operationalization is strongly influenced by both historical and current context. This aspect alone makes it imperative that the methodology used is post-positive and takes ontologically stratified context into account. The NSW Health Monitoring and Evaluation Framework did not make provision for assessment of context or mechanism of effect. We describe here a multilevel approach including a continuous improvement approach through constant comparison and triangulation of mixed method findings. Utilising the MRC framework for evaluating complex interventions within a critical realist methodology, enabled us to study both mechanisms of effect and context. Lessons learned: Evaluation of integrated care interventions will require a pluralist approach to methodology. It is possible to design evaluation approaches that allow study of context, mechanism, reach and efficacy in a complex layered design as used for integrated care initiatives. Limitations: The approach utilised was contrained by the requirements of the policy and funding organisation. We did not fully explore the application of Theory of Change and complexity science within the MRC framework. Suggestions for future research: We recommend that further theoretical and applied research be undertaken to advance the methods and tools available for evaluation of complex multi-layered integrated care initiatives. Reference: 1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655

Introduction: In March 2014, the New South Wales (NSW) Government (Australia) announced the NSW Integrated Care Strategy. In response, a family-centred, population-based, integrated care initiative for vulnerable families and their children in Sydney, Australia was developed. The initiative was called 'Healthy Homes and Neighbourhoods'. A realist translational social epidemiology programme of research and collaborative design is at the foundation of its evaluation. Theory and Method: The UK Medical Research Council (MRC) Framework for evaluating complex health interventions was adapted. This has four components, namely 1) development, 2) feasibility/piloting, 3) evaluation and 4) implementation. We adapted the Framework to include: critical realist, theory driven, and continuous improvement approaches. The modified Framework underpins this research and evaluation protocol for 'Healthy Homes and Neighbourhoods'. Discussion: The NSW Health Monitoring and Evaluation Framework did not make provisions for assessment of the programme layers of context, or the effect of programme mechanism at each level. We therefore developed a multilevel approach that uses mixed-method research to examine not only outcomes, but also 'what is working for whom and why'.