Learning from the CO-CREATE project: A protocol for systems thinking across research (STAR).

The CO-CREATE project aimed to work with young people to create, inform, and disseminate obesity-preventive evidence-based policies using a complex systems perspective. This paper draws lessons from this experience and proposes a protocol for embedding systems thinking within a research project. We first draw on existing systems thinking frameworks to analyze how systems thinking was translated across CO-CREATE, including the flow and relationship between the work packages and in the methods used. We then take the lessons from CO-CREATE and the principles of existing systems thinking frameworks-which focus on various points of intervention planning and delivery but not on research projects as a whole-to formulate a protocol for embedding systems thinking across a research project. Key lessons for future planning and delivery of systems-oriented research projects include incorporating "boundary critique" by capturing key stakeholder (adolescent) values and concerns; working to avoid social exclusion; ensuring methodological pluralism to allow for reflection and responsiveness (with methods ranging from group model building, Photovoice, and small group engagement); getting policy recipients to shape key questions by understanding their views on the critical drivers of obesity early on in the project; and providing opportunity for intraproject reflection along the way.

The development of the NOURISHING and MOVING benchmarking tools to monitor and evaluate national governments' nutrition and physical activity policies to address obesity in the European region.

Despite assurances of government action, the burden of non-communicable diseases (NCDs) and overweight and obesity is continuing to grow at an alarming rate both globally and in Europe. The NOURISHING and MOVING policy frameworks outline a comprehensive set of policy actions across 6 domains and 16 policy areas in which national governments should take action to promote healthy diets and physical activity. Monitoring and benchmarking these policies is important for assessing progress on obesity and NCD prevention. This paper describes the participatory process for developing benchmarking tools structured around the policy areas of the NOURISHING and MOVING policy frameworks. They consist of a set of indicators and policy attributes that assess government support in promoting healthy nutrition and physical activity. They are adolescent relevant as they capture policy actions that target or impact adolescents. The benchmarking tools are designed to monitor progress on national government action on nutrition and physical activity based on aspirational standards. They will be applied in 27 European countries initially and are aimed at policymakers, researchers, and civil society, to track progress, develop the research infrastructure on effectiveness of NCD prevention policies at population level, and support advocacy efforts.

Pilot test of the NOURISHING policy index-Assessing governmental nutrition policies in five European countries.

The NOURISHING database is a repository of more than 1000 verified nutrition and diet-related governmental policy actions currently in effect globally. The database is a unique and rich data source on governmental policy actions with a potential for developing tools that capture the overall policy efforts in a country, identify policy gaps, and enable cross-national comparisons. Policy actions from a sample of five European countries have been benchmarked against aspirational standards using the NOURISHING benchmarking tool. This paper presents the results of the pilot testing from the benchmarking process for the construction of the NOURISHING policy index. The development of the index was guided by existing tools for developing composite indicators. The findings from the pilot test indicate that the NOURISHING policy index can identify both policy gaps and cross-national policy differences. These results demonstrate that the policy index merits testing on a larger sample to identify potential refinements.

Scan of physical activity policy actions in Europe: Lessons learned from populating the MOVING database.

Adequate levels of physical activity are important for population health. Policy databases can track, monitor, and compare the development and implementation of physical activity policy actions and are populated by different methods. The new MOVING database, developed through the Confronting Obesity: Co-creating Policy with Youth (CO-CREATE) project, collates governmental policy actions designed to increase physical activity and is populated by an in-depth scan of implemented national policy actions. This paper presents lessons learned from conducting the policy scan across 27 European countries. Policy actions were identified using a structured search protocol from preselected sources, assessed against pre-specified inclusion criteria and verified by an in-country expert. 625 eligible national implemented policy actions were identified. Challenges included policy actions falling out of scope, a lack of available information on policy actions, difficulty in identifying policy actions using specific search terms, and increased resource requirements for translation of policy actions into English. The scan indicated improvements, which informed protocol modifications. Identifying the challenges and opportunities around conducting a policy scan is necessary to understand and assess the reliability, validity, and utility of a policy database. The policy scan will help to deliver a comprehensive picture of physical activity policy actions across Europe.

Heavy Metal Content in PolyfloralHoney and Potential Health Risk. A Case Study of Copșa Mica, Romania.

Honey is both a complex food and medicine as well as a healthy alternative to refined sugar. Besides a complex mixture of carbohydrates, honey contains other minor substances which may threaten human health in excess concentrations. Several environmental conditions can affect the quality of honey. This research paper aims to measure the degree of heavy metals (Lead (Pb), Cadmium (Cd), Zinc (Zn), and Copper (Cu)) in some polyfloral honey from an industrial area of Romania, considered to be one of the most polluted regions in Eastern Europe. The samples were collected from six stationary apiaries and analysed using the atomic absorption spectrometry method. The content of Pb was higher in the sampling areas exposed directly to the polluted air masses. Cd concentration decreases exponentially while Cu concentration increases as the distance from the source of pollution increases. The checking of the quality of polyfloral honey from local producers is imperative because this product is intended to be consumed by the beekeeper's family or the local community without being sold to an authorised processor. The results of the study can help to set a threshold for the concentration of Pb and Cd in honey marketed in the European Union.

REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH): study protocol for a pilot randomised controlled trial.

BACKGROUND: Guidelines recommend an initial intravenous (IV) fluid bolus of 30 ml/kg isotonic crystalloid for patients with sepsis and hypotension. However, there is a lack of evidence from clinical trials to support this. Accumulating observational data suggest harm associated with the injudicious use of fluids in sepsis. There is currently equipoise regarding liberal or restricted fluid-volume resuscitation as first-line treatment for sepsis-related hypotension. A randomised trial comparing these two approaches is, therefore, justified. METHODS/DESIGN: The REstricted Fluid REsuscitation in Sepsis-associated Hypotension trial (REFRESH) is a multicentre, open-label, randomised, phase II clinical feasibility trial. Participants will be patients presenting to the emergency departments of Australian metropolitan hospitals with suspected sepsis and a systolic blood pressure of < 100 mmHg, persisting after a 1000-ml fluid bolus with isotonic crystalloid. Participants will be randomised to either a second 1000-ml fluid bolus (standard care) or maintenance rate fluid only, with the early commencement of a vasopressor infusion to maintain a mean arterial pressure of > 65 mmHg, if required (restricted fluid). All will receive further protocolised fluid boluses (500 ml or 250 ml, respectively), if required during the 6-h study period. The primary outcome measure is total volume administered in the first 6 h. Secondary outcomes include fluid volume at 24 h, organ support 'free days' to day 28, 90-day mortality, and a range of feasibility and process-of-care measures. Participants will also undergo serial measurement, over the first 24 h, of biomarkers of inflammation, endothelial cell activation and glycocalyx degradation for comparison between the groups. DISCUSSION: This is the first randomised trial examining fluid volume for initial resuscitation in septic shock in an industrialised country. A pragmatic, open-label design will establish the feasibility of undertaking a large, international, multicentre trial with sufficient power to assess clinical outcomes. The embedded biomarker study aims to provide mechanistic plausibility for a larger trial by defining the effects of fluid volume on markers of systemic inflammation and the vascular endothelium. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry, ID: ACTRN12616000006448. Registered on 12 January 2016.

Improving quality for maternal care - a case study from Kerala, India.

BACKGROUND: The implementation of maternal health guidelines remains unsatisfactory, even for simple, well established interventions. In settings where most births occur in health facilities, as is the case in Kerala, India, preventing maternal mortality is linked to quality of care improvements. CONTEXT: Evidence-informed quality standards (QS), including quality statements and measurable structure and process indicators, are one innovative way of tackling the guideline implementation gap. Having adopted a zero tolerance policy to maternal deaths, the Government of Kerala worked in partnership with the Kerala Federation of Obstetricians & Gynaecologists (KFOG) and NICE International to select the clinical topic, develop and initiate implementation of the first clinical QS for reducing maternal mortality in the state. Description of practice: The NICE QS development framework was adapted to the Kerala context, with local ownership being a key principle. Locally generated evidence identified post-partum haemorrhage as the leading cause of maternal death, and as the key priority for the QS. A multidisciplinary group (including policy-makers, gynaecologists and obstetricians, nurses and administrators) was established. Multi-stakeholder workshops convened by the group ensured that the statements, derived from global and local guidelines, and their corresponding indicators were relevant and acceptable to clinicians and policy-makers in Kerala. Furthermore, it helped identify practical methods for implementing the standards and monitoring outcomes. LESSONS LEARNED: An independent evaluation of the project highlighted the equal importance of a strong evidence-base and an inclusive development process. There is no one-size-fits-all process for QS development; a principle-based approach might be a better guide for countries to adapt global evidence to their local context.

Dabigatran deliberate overdose: two cases and suggestions for laboratory monitoring.

CONTEXT: Dabigatran etexilate (dabigatran) is a direct thrombin inhibitor anticoagulant agent. There is limited information about the changes in coagulation profile and outcomes in overdose. A monoclonal antibody has been developed to neutralize the anticoagulant effect of dabigatran. Case reports describe enhanced clearance of dabigatran by haemodialysis as an intervention to prevent haemorrhagic complications - however, the threshold for initiating haemodialysis is not well defined in an asymptomatic patient with normal renal function. CASE DETAILS: Two patients presented following deliberate dabigatran overdoses. A 55-year-old woman ingested 10 × 150 mg dabigatran. A 21-year-old woman with a history of systemic lupus erythematosus and pulmonary embolus ingested 100 × 110 mg dabigatran. Both were admitted to the intensive care unit and managed expectantly. Serial coagulation tests normalized over 60 h. The half-life of dabigatran was not prolonged following overdose, being calculated between 7 and 11 h in each case. There was positive correlation between international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (aPTT) with plasma dabigatran levels. CONCLUSION: There is limited experience with dabigatran overdoses. Normal aPTT, PT and INR assays 12 h following deliberate ingestion indicate that the drug concentration is not high. Individual risk assessment of bleeding risk needs to be formulated for each patient and expectant management is reasonable in the presence of normal renal function and absent risk factors for bleeding.

Mapping Priority Setting in Health in 17 Countries Across Asia, Latin America, and sub-Saharan Africa.

Abstract-As more low- and middle-income countries (LMICs) commit to universal health coverage (UHC), there is a growing need for rational priority setting using health technology assessment (HTA) and other policy tools. We describe an approach for rapidly mapping LMICs' capacity and needs for rational priority setting, aimed at identifying candidate countries where technical assistance would be most viable, and present our findings from applying this approach to three continents. Drawing on the multiple streams theory and a conceptual model of HTA in health systems, we developed qualitative and quantitative indicators for political commitment, current position along UHC journey, institutional and technical capacity, health system financing characteristics, and potential economies of scale in rational priority setting and associated data collection tools. We additionally defined criteria for shortlisting countries, emphasizing feasibility of technical assistance. We purposively sampled 17 countries and gathered data up to May 2014 from various sources and applied the shortlisting criteria to these countries. The four shortlisted countries (Indonesia, Myanmar, South Africa, Ghana) had varying capacities for rational priority setting and shared clear demand for rational priority setting as a means of achieving UHC. Indonesia was the strongest candidate for technical assistance, given the potential scale of impact on its large population and potential lessons for LMICs transitioning from aid. We conducted additional in-country scoping, and technical assistance to support HTA development in Indonesia is now underway. Our approach is of potential value to development funders and initiatives seeking to maximize the impact of their aid investments in support of UHC.

The need to look at antibiotic resistance from a health systems perspective.

Current use, misuse, and overuse of antibiotics raise dangers and ethical dilemmas that cannot be solved in isolation, exclusively within a health system building block or even within the health sector only. There is a need to tackle antibiotic resistance emergence and containment on levels ranging from individuals, households, and the communities, to health care facilities, the entire health sector, and finally to national and global levels. We analyse emergence of antibiotic resistance based on interdependencies between health systems resources. We further go beyond the health system building blocks, to look at determinants of antibiotic resistance referring to wider global dynamics. Multi-level governance is the key for successful action in containment strategies. This will involve, in a comprehensive way, patients, health facilities where they receive care, health systems to which these facilities pertain, and the wider national context as well as the global community that influences the functioning of these health systems. In order to be effective and sustainable in both high and low-resource settings, implementation of containment interventions at all these levels needs to be managed based on existing theories and models of change. Although ministries of health and the global community must provide vision and support, it is important to keep in mind that containment interventions for antibiotic resistance will target individuals, consumers as well as providers.

Patient perceptions of the potential lethality associated with deliberate self-poisoning.

INTRODUCTION: Little is known about patient perceptions of the lethality of their overdose. Our aim was to compare patient perceptions with the risk assessment of clinical toxicologists. METHODS: A prospective observational study of overdose patients presenting to a tertiary hospital. Eligible patients were surveyed once they were medically fit for psychiatric evaluation. Descriptive data were collected, including the Pierce Suicide Intent Scale (SIS). In response to 'how dangerous did you think this overdose was when you took the tablets?' patients marked a 10 cm VAS, with 0 = would be harmless, 10 = certain to cause death. A panel of clinical toxicologists independently made a risk assessment on a 10 cm VAS, with 0 = non-toxic ingestion and 10 = uniform lethality even with full medical intervention. RESULTS: Of 202 patients enrolled, 118 (58.4%, 95% CI 51-65) were female; median age 33 years (interquartile range [IQR] 24-42). One hundred and three (51%, 95% CI 44-58) stated it was their intention to kill themselves and 44 (21.8%, 95% CI 16-28) wrote a suicide note. They most commonly used their own prescription medications (141, 69.8%, 95% CI 63-76). The median patient visual analog scale (VAS) was 5.8 (IQR 2.3-8.3) and median toxicology VAS was 1.4 (IQR 0.6-2.8); this difference was statistically significant (P < 0.0001). The correlation between the patient visual analog scale (VAS) and Pierce SIS (median 8.5/25 [IQR 4-12]) was strong (r= 0.73, P < 0.0001). CONCLUSIONS: Patient perceptions of the lethality of their overdose are correlated with their suicidal intent as measured on the Pierce SIS, with a significant mismatch between patient perceptions and the toxicological risk assessment.