National plans and awareness campaigns as priorities for achieving global brain health.

Neurological conditions are the leading cause of death and disability combined. This public health crisis has become a global priority with the introduction of WHO's Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders 2022-2031 (IGAP). 18 months after this plan was adopted, global neurology stakeholders, including representatives of the OneNeurology Partnership (a consortium uniting global neurology organisations), take stock and advocate for urgent acceleration of IGAP implementation. Drawing on lessons from relevant global health contexts, this Health Policy identifies two priority IGAP targets to expedite national delivery of the entire 10-year plan: namely, to update national policies and plans, and to create awareness campaigns and advocacy programmes for neurological conditions and brain health. To ensure rapid attainment of the identified priority targets, six strategic drivers are proposed: universal community awareness, integrated neurology approaches, intersectoral governance, regionally coordinated IGAP domestication, lived experience-informed policy making, and neurological mainstreaming (advocating to embed brain health into broader policy agendas). Contextualised with globally emerging IGAP-directed efforts and key considerations for intersectoral policy design, this novel framework provides actionable recommendations for policy makers and IGAP implementation partners. Timely, synergistic pursuit of the six drivers might aid WHO member states in cultivating public awareness and policy structures required for successful intersectoral roll-out of IGAP by 2031, paving the way towards brain health for all.

Understanding public procurement within the health sector: a priority in a post-COVID-19 world.

Every year, over 250,000 public authorities in the European Union (EU) spend about 14% of GDP on the purchase of services, works and supplies. Many are in the health sector, a sector in which public authorities are the main buyers in many countries. When these purchases exceed threshold values, EU public procurement rules apply. Public procurement is increasingly being promoted as a tool for improving efficiency and contributing to better health outcomes, and as a policy lever for achieving other government goals, such as innovation, the development of small and medium-sized enterprises, sustainable green growth and social objectives like public health and greater inclusiveness. In this paper, we describe the challenges that arise within health care systems with public procurement and identify potential solutions to them. We examined the tendering of pharmaceuticals, health technology, and e-health. In each case we identify a series of challenges relating to the complexity of the procurement process, imbalances in power on either side of transactions and the role of procurement in promoting broader public policy objectives. Finally, we recommend several actions that could stimulate better procurement, and suggest a few areas where further EU cooperation can be pursued.

Improving the quality of care for people with chronic diseases: translating recommendations to practice.

INTRODUCTION: Aim of this paper is to present a guide for translating to practice an evidence-based set of Quality Criteria and Recommendations (QCR) to promote the implementation of policies and practices in the field of health promotion, disease prevention and care for people with chronic diseases. METHODS: The guide is based on real-world experiences of eight European pilot actions using QCR as a framework for practice design, development, implementation, monitoring and evaluation. All partners implemented their respective practices by following the same agreed process. RESULTS: The implementation method was summarized in seven steps where each of one outline a particular phase of the process. The guide provides a step-by-step tutorial for the implementation of QCR. CONCLUSIONS: Practical experiences from the pilot actions show the potential value of using the QCR in designing and implementing practices to improve the quality of care for people with chronic diseases.

Resilience Testing of Health Systems: How Can It Be Done?

The resilience of health systems has received considerable attention as of late, yet little is known about what a resilience test might look like. We develop a resilience test concept and methodology. We describe key components of a toolkit and a 5-phased approach to implementation of resilience testing that can be adapted to individual health systems. We develop a methodology for a test that is balanced in terms of standardization and system-specific characteristics/needs. We specify how to work with diverse stakeholders from the health ecosystem via participatory processes to assess and identify recommendations for health system strengthening. The proposed resilience test toolkit consists of "what if" adverse scenarios, a menu of health system performance elements and indicators based on an input-output-outcomes framework, a discussion guide for each adverse scenario, and a traffic light scorecard template. The five phases of implementation include Phase 0, a preparatory phase to adapt the toolkit materials; Phase 1: facilitated discussion groups with stakeholders regarding the adverse scenarios; Phase 2: supplemental data collection of relevant quantitative indicators; Phase 3: summarization of results; Phase 4: action planning and health system transformation. The toolkit and 5-phased approach can support countries to test resilience of health systems, and provides a concrete roadmap to its implementation.

Redesigning diabetes care delivery in Serbia, using JA CHRODIS Recommendations and criteria.

INTRODUCTION: Managing non-communicable diseases (NCDs) requires redesigning health care delivery to achieve better coordination of services at all levels of health care. The aim of this study was improving prevention and strengthening high quality of care for NCDs by using type 2 diabetes as a model disease. METHODS: The mix method approach served to analyse the impact of the intervention processes. Source of information were routine health statistics, interviews and observation. Key Performance Indicators in defined Improvement Areas assisted in the quality of diabetes care assessment. RESULTS AND DISCUSSION: During the study the National Diabetes Centre (NDC) was established. The NDC experts organized numerous educational events, 316 physicians and nurses have participated. New electronic data base was implemented in 20 pilot Primary Health Care Centres (PHCCs) with 38,833 electronic diabetes records. CONCLUSIONS: The intervention led to establishment of the NDC, strengthening competences of health care professionals and to the renewal of the Diabetes Care Units in PHCCs included in the study.

Fostering the Quality of Care for People with Chronic Diseases, from Theory to Practice: The Development of Good Practices in Disease Prevention and Care in JA CHRODIS PLUS Using JA CHRODIS Recommendations and Quality Criteria.

In the frame of joint action in chronic diseases (JA CHRODIS), an extensive process at the European Union level was carried out to identify a core set of quality criteria and to formulate recommendations that improved prevention, early detection, and quality of care for people with chronic diseases. Diabetes was used as a model disease. The core set of quality criteria may be applied to develop and improve practices, programs, strategies, and policies in various domains (e.g., prevention, care, health promotion, education, and training). The quality criteria are general enough to be applied in countries with different political, administrative, social, and health care organizations. Moreover, they can be applied to a number of other chronic diseases. JA CHRODIS recommendations and quality criteria are being tested in a series of pilot actions within the JA CHRODIS PLUS. A total of 15 partners representing nine European countries worked together to implement pilot actions and generate practical lessons that could contribute to the further uptake and use of JA CHRODIS recommendations. Special emphasis is given to meaningful patient involvement in co-designing the pilot actions and to the sustainability and scalability of the pilot actions. These insights were found to be at the core of the learning from pilot actions to foster high quality care for people with chronic diseases.

Multimorbidity care model: Recommendations from the consensus meeting of the Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS).

Patients with multimorbidity have complex health needs but, due to the current traditional disease-oriented approach, they face a highly fragmented form of care that leads to inefficient, ineffective, and possibly harmful clinical interventions. There is limited evidence on available integrated and multidimensional care pathways for multimorbid patients. An expert consensus meeting was held to develop a framework for care of multimorbid patients that can be applied across Europe, within a project funded by the European Union; the Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). The experts included a diverse group representing care providers and patients, and included general practitioners, family medicine physicians, neurologists, geriatricians, internists, cardiologists, endocrinologists, diabetologists, epidemiologists, psychologists, and representatives from patient organizations. Sixteen components across five domains were identified (Delivery of Care; Decision Support; Self Management Support; Information Systems and Technology; and Social and Community Resources). The description and aim of each component are described in these guidelines, along with a summary of key characteristics and relevance to multimorbid patients. Due to the lack of evidence-based recommendations specific to multimorbid patients, this care model needs to be assessed and validated in different European settings to examine specifically how multimorbid patients will benefit from this care model, and whether certain components have more importance than others.

Cost of severe hypoglycaemia in nine European countries.

OBJECTIVE: Complications contribute largely to the economic gravity of diabetes mellitus (DM). How they arise and are treated differs substantially between countries. This paper assesses the total annual, direct, and indirect cost of severe hypoglycemia events (SHEs) in nine European countries: Bulgaria, Croatia, the Czech Republic, Greece, Hungary, Macedonia/the former Yugoslav Republic of Macedonia (MK), Poland, Slovenia, and Spain. METHODS: Data was collected on epidemiology, treatment structure, SHE-driven resource consumption, and unit costs. Two systematic reviews-on the SHE rates and the resources used for treatment-and data on the days-of-work lost due to SHE along with salaries and employment rates were used. The total SHE cost in each country was calculated and how the differences are driven by individual parameters was analysed. RESULTS: The annual costs of SHEs varied in absolute terms from €379,951.25 in MK up to €58,429,684.40 in Spain, or-when expressed per one drug-treated DM patient-from €5.47 in Bulgaria up to €17.74 in Spain. Indirect cost constituted between 6.01% (MK) and 26.49% (Hungary) of the total cost. The differences between countries are driven mostly by the cost of treating a single event, and this is related to general differences in prices. LIMITATIONS: The main limitation is the lack of good quality data in some parts, and the necessity to use mean-value imputations, experts' opinions, etc. Additionally, we only considered DM treatment as the SHE driver, while other elements, e.g. style of living, may contribute substantially. CONCLUSIONS: A common framework can be applied to estimate the economic burden of SHE in various countries, allowing one to identify the drivers of differences in cost. Treating DM is complex, and so no resolute conclusions ought to be drawn as to whether SHE management is better in one country than another.

Health promotion interventions in type 2 diabetes.

AIM: To present the most common quality criteria in health promotion interventions in type 2 diabetes mellitus (T2DM). METHODS: A systematic literature search was conducted to identify review articles, health technology assessments and policy reports of evaluated health promotion interventions in T2DM. A descriptive analysis of study characteristics and evaluation criteria are presented. RESULTS: Seven studies met the inclusion criteria. The findings indicate that the most common health promotion interventions used in T2DM are initiatives targeting health care professionals. The main ambition of the programs was to increase the collaboration between health care professionals and patients, and between health care centres, program managers and community stakeholders. CONCLUSIONS: This investigation extends our knowledge of the most common health promotion interventions in T2DM and which structure, process and outcome measurements that are reported in such interventions. Future research could usefully explore how the effectiveness of multicomponent and complex interventions may be evaluated and extend the association of these factors into other settings and in relation to other lifestyle related chronic diseases.

Quality indicators for diabetes prevention programs in health care targeted at people at high risk.

OBJECTIVE: Type 2 diabetes can be efficiently prevented by lifestyle intervention provided for people at high diabetes risk. The aim of this paper was to conduct a literature search on existing quality indicators for type 2 diabetes prevention and to collate and present a set of indicators that could be applied in European countries with different health care systems and cultures. METHODS: Scientific and grey literature was searched for relevant studies using electronic databases. We also hand searched previous systematic reviews and reference lists of relevant articles. RESULTS: The only publication identified was the report presenting the results from the IMAGE project. The IMAGE indicators were used as the basis for the proposed indicators. CONCLUSIONS: Publications on quality indicators of diabetes prevention programmes are scarce. The quality indicators presented here are a first step toward the definition of a core set of European indicators to monitor and improve the quality of diabetes prevention.

Education and health professionals training programs for people with type 2 diabetes: a review of quality criteria.

OBJECTIVE: To contribute to the development of a set of quality criteria for patient education and health professionals training that could be applied in European countries. METHODS: Literature review quality criteria, pre-selection based on a comparison of the criteria, peer group and expert based selection of the criteria. RESULTS: 14 quality criteria were selected: goals, rationale, target group, setting, scheduling of the education/training sessions, environmental requirements, qualification of the trainers/educators, core components of the educator/trainer's role, curriculum, education methods, education didactics, monitoring of the effectiveness and quality of the program, implementation level and source of funding. DISCUSSION: A set of preliminary quality criteria for patient education and health professionals training was developed, which could be applied in European countries.

National Diabetes Plans: can they support changes in health care systems to strengthen diabetes prevention and care?

Healthcare systems do not fit well with the "modern" patient, who has a right to autonomy and self-determination. The services that are designed and delivered in policy contexts are not prone to encourage innovation. National Diabetes Plans, defined as "any formal strategy for improving diabetes policy, services and outcomes that encompass structured and integrated or linked activities which are planned and co-ordinated nationally and conducted at the national, regional, and local level", may hold a great potential not only to improve prevention and care for type 2 diabetes, but also for transforming healthcare delivery. Today, changes to adapt healthcare delivery tend to be implemented within existing provider structures, with limited understanding of specific context, structures, processes and potential for change. National Diabetes Plan can be a diagnostic tool for barriers, can be a driver for planning the change, and can help develop capacities and competences that are needed to strengthen healthcare systems to better address health promotion and chronic diseases.

Pancreatic exocrine insufficiency, diabetes mellitus and serum nutritional markers after acute pancreatitis.

AIM: To investigate impairment and clinical significance of exocrine and endocrine pancreatic function in patients after acute pancreatitis (AP). METHODS: Patients with AP were invited to participate in the study. Severity of AP was determined by the Atlanta classification and definitions revised in 2012. Pancreatic exocrine insufficiency (PEI) was diagnosed by the concentration of fecal elastase-1. An additional work-up, including laboratory testing of serum nutritional markers for determination of malnutrition, was offered to all patients with low levels of fecal elastase-1 FE. Hemoglobin A1c or oral glucose tolerance tests were also performed in patients without prior diabetes mellitus, and type 3c diabetes mellitus (T3cDM) was diagnosed according to American Diabetes Association criteria. RESULTS: One hundred patients were included in the study: 75% (75/100) of patients had one attack of AP and 25% (25/100) had two or more attacks. The most common etiology was alcohol. Mild, moderately severe and severe AP were present in 67, 15 and 18% of patients, respectively. The mean time from attack of AP to inclusion in the study was 2.7 years. PEI was diagnosed in 21% (21/100) of patients and T3cDM in 14% (14/100) of patients. In all patients with PEI, at least one serologic nutritional marker was below the lower limit of normal. T3cDM was more frequently present in patients with severe AP (P = 0.031), but was also present in some patients with mild and moderately severe AP. PEI was present in all degrees of severity of AP. There were no statistically significantly differences according to gender, etiology and number of AP attacks. CONCLUSION: As exocrine and endocrine pancreatic insufficiency can develop after AP, routine follow-up of patients is necessary, for which serum nutritional panel measurements can be useful.

Low prevalence of exocrine pancreatic insufficiency in patients with diabetes mellitus.

INTRODUCTION: Exocrine pancreatic insufficiency (EPI) can occur in patients with diabetes mellitus (DM). Incidence of EPI and its clinical significance remain poorly defined. The aim of our study was to determine whether exocrine pancreatic function is impaired in patients with DM. PATIENTS AND METHODS: One hundred and fifty consecutive patients, mean age 59.0 (± 12.0 years), with DM lasting at least 5 years were included in the study. We included 50 patients with type 1 DM (DM1), 50 insulin-treated patients DM type 2 (DM2-insulin) and 50 non-insulin treated patients with DM type 2 (DM2 no-insulin). Diagnosis of DM was established from health records, lasting 15.0 ± 9.9 years on average. EPI was diagnosed with a fecal elastase-1 concentration (FE1) of less than 200 µg/g (ELISA). RESULTS: FE1 was reduced in 8 (5.4%) patients: mildly reduced (100-200 µg/g) in 4 patients (2.7%) and markedly reduced (<100 µg/g) in 4 patients (2.7%). Frequency of EPI was 3 in DM1, 5 in DM2(insulin) and none in DM2 (no-insulin) groups. CONCLUSIONS: EPI in DM occurred less frequently than in previous studies, probably due to our strict exclusion criteria (age, alcohol intake).

The GFR and GFR decline cannot be accurately estimated in type 2 diabetics.

There are no adequate studies that have formally tested the performance of different estimating formulas in patients with type 2 diabetes both with and without overt nephropathy. Here we evaluated the agreement between baseline GFRs, GFR changes at month 6, and long-term GFR decline measured by iohexol plasma clearance or estimated by 15 creatinine-based formulas in 600 type 2 diabetics followed for a median of 4.0 years. Ninety patients were hyperfiltering. The number of those identified by estimation formulas ranged from 0 to 24:58 were not identified by any formula. Baseline GFR was significantly underestimated and a 6-month GFR reduction was missed in hyperfiltering patients. Long-term GFR decline was also underestimated by all formulas in the whole study group and in hyper-, normo-, and hypofiltering patients considered separately. Five formulas generated positive slopes in hyperfiltering patients. Baseline concordance correlation coefficients and total deviation indexes ranged from 32.1% to 92.6% and from 0.21 to 0.53, respectively. Concordance correlation coefficients between estimated and measured long-term GFR decline ranged from -0.21 to 0.35. The agreement between estimated and measured values was also poor within each subgroup considered separately. Thus, our study questions the use of any estimation formula to identify hyperfiltering patients and monitor renal disease progression and response to treatment in type 2 diabetics without overt nephropathy.

Glomerular hyperfiltration and renal disease progression in type 2 diabetes.

OBJECTIVE: To describe the prevalence and determinants of hyperfiltration (glomerular filtration rate [GFR] ≥120 mL/min/1.73 m(2)), GFR decline, and nephropathy onset or progression in type 2 diabetic patients with normo- or microalbuminuria. RESEARCH DESIGN AND METHODS: We longitudinally studied 600 hypertensive type 2 diabetic patients with albuminuria <200 µg/min and who were retrieved from two randomized trials testing the renal effect of trandolapril and delapril. Target blood pressure (BP) was <120/80 mmHg, and HbA(1c) was <7%. GFR, albuminuria, and glucose disposal rate (GDR) were centrally measured by iohexol plasma clearance, nephelometry in three consecutive overnight urine collections, and hyperinsulinemic euglycemic clamp, respectively. RESULTS: Over a median (range) follow-up of 4.0 (1.7-8.1) years, GFR declined by 3.37 (5.71-1.31) mL/min/1.73 m(2) per year. GFR change was bimodal over time: a larger reduction at 6 months significantly predicted slower subsequent decline (coefficient: -0.0054; SE: 0.0009), particularly among hyperfiltering patients. A total of 90 subjects (15%) were hyperfiltering at inclusion, and 11 of 47 (23.4%) patients with persistent hyperfiltration progressed to micro- or macroalbuminuria versus 53 (10.6%) of the 502 who had their hyperfiltration ameliorated at 6 months or were nonhyperfiltering since inclusion (hazard ratio 2.16 [95% CI 1.13-4.14]). Amelioration of hyperfiltration was independent of baseline characteristics or ACE inhibition. It was significantly associated with improved BP and metabolic control, amelioration of GDR, and slower long-term GFR decline on follow-up. CONCLUSIONS: Despite intensified treatment, patients with type 2 diabetes have a fast GFR decline. Hyperfiltration affects a subgroup of patients and may contribute to renal function loss and nephropathy onset or progression. Whether amelioration of hyperfiltration is renoprotective is worth investigating.

Effects of manidipine and delapril in hypertensive patients with type 2 diabetes mellitus: the delapril and manidipine for nephroprotection in diabetes (DEMAND) randomized clinical trial.

To assess whether angiotensin-converting enzyme inhibitors and third-generation dihydropyridine calcium channel blockers ameliorate diabetic complications, we compared glomerular filtration rate (GFR; primary outcome), cardiovascular events, retinopathy, and neuropathy in 380 hypertensive type 2 diabetics with albuminuria <200 mg/min included in a multicenter, double-blind, placebo-controlled trial (DEMAND [Delapril and Manidipine for Nephroprotection in Diabetes]) and randomized to 3-year treatment with manidipine/delapril combination (10/30 mg/d; n=126), delapril (30 mg/d; n=127), or placebo (n=127). GFR was centrally measured by iohexol plasma clearance. Median monthly GFR decline (interquartile range [IQR]) was 0.32 mL/min per 1.73 m(2) (IQR: 0.16-0.50 mL/min per 1.73 m(2)) on combined therapy, 0.36 mL/min per 1.73 m(2) (IQR: 0.18-0.53 mL/min per 1.73 m(2)) on delapril, and 0.30 mL/min per 1.73 m(2) (IQR: 0.12-0.50 mL/min per 1.73 m(2)) on placebo (P=0.87 and P=0.53 versus combined therapy or delapril, respectively). Similar findings were observed when baseline GFR values were not considered for slope analyses. Albuminuria was stable in the 3 treatment groups. The hazard ratio (95% CI) for major cardiovascular events between combined therapy and placebo was 0.17 (0.04-0.78; P=0.023). Among 192 subjects without retinopathy at inclusion, the hazard ratio for developing retinopathy between combined therapy and placebo was 0.27 (0.07-0.99; P=0.048). Among 200 subjects with centralized neurological evaluation, the odds ratios for peripheral neuropathy at 3 years between combined therapy or delapril and placebo were 0.45 (0.24-0.87; P=0.017) and 0.52 (0.27-0.99; P=0.048), respectively. Glucose disposal rate decreased from 5.8±2.4 to 5.3±1.9 mg/kg per min on placebo (P=0.03) but did not change on combined or delapril therapy. Treatment was well tolerated. In hypertensive type 2 diabetic patients, combined manidipine and delapril therapy failed to slow GFR decline but safely ameliorated cardiovascular disease, retinopathy, and neuropathy and stabilized insulin sensitivity.

Association between adiponectin and low-grade albuminuria is BMI-dependent in type 2 diabetes.

AIM: Low-grade albuminuria is a marker of increased risk for both cardiovascular and renal disease. Adiponectin, with its insulin-sensitizing, anti-inflammatory and antiatherogenic properties, is associated with cardiovascular as well as renal disease. Limited and conflicting data exist on the association of adiponectin with low-grade albuminuria. Our aim was to explore the association of plasma adiponectin and low-grade albuminuria in patients with type 2 diabetes. Furthermore, we were interested whether this association is dependent upon insulin sensitivity. METHODS: In this cross-sectional study, plasma adiponectin and urinary albumin excretion rate (UAER) were determined in 71 patients by radioimmunoassay. Insulin sensitivity was measured by hyperinsulinemic euglycemic clamp and expressed as the M value. The relationship between variables was described using univariate and multiple linear regression. RESULTS: Adiponectin and UAER were negatively associated (R = -0.285, p < 0.05) only in patients with BMI >25. The association was independent of the clamp-derived M value, gender, BMI, arterial pressure or cholesterol. CONCLUSION: In obese patients with type 2 diabetes, there is an inverse association between adiponectin and low-grade albuminuria, the association being independent of insulin resistance. The consequences of such a relationship in terms of renal disease progression and cardiovascular survival remain to be evaluated.