Barriers to improved dyslipidemia control: Delphi survey of a multidisciplinary panel.

OBJECTIVE: To assess the barriers that make it difficult for the health care professionals (physicians, nurses and health care managers) to achieve a better control for dyslipidemia in Spain. METHODS: The study has an observational design and was performed using the modified Delphi technique. One hundred and forty-nine panel members from medicine, nursing and health care management fields and from different Spanish regions were selected randomly and were invited to participate. Individual and anonymous opinions were asked by answering a 42-items questionnaire via e-mail (two rounds were done). Level of agreement was assessed using measures of central tendency and dispersion. We analysed commonalities/differences between the three groups (Kappa index and McNemar chi-square). RESULTS: Response rate: 81%. The agreement index was 33.3 (95% CI: 18.9-47.7). Regarding the non-compliance with therapy, it improves with patient education degree in dyslipidemia, patient motivation, the agreement on decisions with the patient and with the use of cardiovascular risk measure and it gets worse with lack of information on the objectives to achieve. Clinical inertia improves with professional's motivation, cardiovascular risk calculation, training on objectives and the use of indicators and it gets worse with lack of treatment goals. CONCLUSION: Different perceptions and attitudes between medicine, nursing and health care management were found. An agreement in interventions in non-compliance and clinical inertia to improve dyslipidemia control was reached.

Transforming experimental radiology: Design and implementation of an innovative ePACS image storage system for AI imaging research environments.

INTRODUCTION AND PURPOSE: We present the needs, design, development, implementation, and accessibility of a crafted experimental PACS (ePACS) system to securely store images, ensuring efficiency and ease of use for AI processing, specifically tailored for research scenarios, including phantoms, animal and human studies and quality assurance (QA) exams. The ePACS system plays a crucial role in any medical imaging departments that handle non-care profile studies, such as protocol adjustments and dummy runs. By effectively segregating non-care profile studies from the healthcare assistance, the ePACS usefully prevents errors both in clinical practice and storage security. METHODS AND RESULTS: The developed ePACS system considers the best practices for management, maintenance, access, long-term storage and backups, regulatory audits, and economic aspects. Moreover, key aspects of the ePACS system include the design of data flows with a focus on incorporating data security and privacy, access control and levels based on user profiles, internal data management policies, standardized architecture, infrastructure and application monitorization and traceability, and periodic backup policies. A new tool called DicomStudiesQA has been developed to standardize the analysis of DICOM studies. The tool automatically identifies, extracts, and renames series using a consistent nomenclature. It also detects corrupted images and merges separated dynamic series that were initially split, allowing for streamlined post-processing. DISCUSSION AND CONCLUSIONS: The developed ePACS system encompasses a successful implementation, both in hospital and research environments, showcasing its transformative nature and the challenging yet crucial transfer of knowledge to industry. This underscores the practicality and real-world applicability of our innovative approach, highlighting the significant impact it has on the field of experimental radiology.

Scaling up and implementing the digital Survivorship Passport tool in routine clinical care - The European multidisciplinary PanCareSurPass project.

BACKGROUND: Childhood cancer survivors (CCS), of whom there are about 500,000 living in Europe, are at an increased risk of developing health problems [1-6] and require lifelong Survivorship Care. There are information and knowledge gaps among CCS and healthcare providers (HCPs) about requirements for Survivorship Care [7-9] that can be addressed by the Survivorship Passport (SurPass), a digital tool providing CCS and HCPs with a comprehensive summary of past treatment and tailored recommendations for Survivorship Care. The potential of the SurPass to improve person-centred Survivorship Care has been demonstrated previously [10,11]. METHODS: The EU-funded PanCareSurPass project will develop an updated version (v2.0) of the SurPass allowing for semi-automated data entry and implement it in six European countries (Austria, Belgium, Germany, Italy, Lithuania and Spain), representative of three infrastructure healthcare scenarios typically found in Europe. The implementation study will investigate the impact on person-centred care, as well as costs and processes of scaling up the SurPass. Interoperability between electronic health record systems and SurPass v2.0 will be addressed using the Health Level Seven (HL7) International interoperability standards. RESULTS: PanCareSurPass will deliver an interoperable digital SurPass with comprehensive evidence on person-centred outcomes, technical feasibility and health economics impacts. An Implementation Toolkit will be developed and freely shared to promote and support the future implementation of SurPass across Europe. CONCLUSIONS: PanCareSurPass is a novel European collaboration that will improve person-centred Survivorship Care for CCS across Europe through a robust assessment of the implementation of SurPass v2.0 in different healthcare settings.

Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study.

BACKGROUND: Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs. METHODS: This was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist. RESULTS: Of 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe. CONCLUSION: Lanreotide Autogel provided effective tumour stabilisation and PFS >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18.

Factors Influencing Implementation of the Survivorship Passport: The IT Perspective.

Compared to the general population, childhood cancer survivors represent a vulnerable population as they are at increased risk of developing health problems, known as late effects, resulting in excess morbidity and mortality. The Survivorship Passport aims to capture key health data about the survivors and their treatment, as well as personalized recommendations and a care plan with the aim to support long-term survivorship care. The PanCareSurPass (PCSP) project building on the experience gained in an earlier implementation in Giannina Gaslini Institute, Italy, will implement and rigorously assess an integrated, HL7 FHIR based, implementation of the Survivorship Passport. The six implementation countries, namely Austria, Belgium, Germany, Italy, Lithuania, and Spain, are supported by different national or regional digital health infrastructures and Electronic Medical Record (EMR) systems. Semi structured interviews were carried out to explore potential factors affecting implementation, identify use cases, and coded data that can be semi-automatically transferred from the EMR to SurPass. This paper reflects on findings of these interviews and confirms the need for a multidisciplinary and multi-professional approach towards a sustainable and integrated large-scale implementation of the Survivorship Passport across Europe.

Lanthanum carbonate reduces FGF23 in chronic kidney disease Stage 3 patients.

BACKGROUND: In chronic kidney disease (CKD) patients, the ability to excrete a phosphate load is impaired. Compensatory increase in parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) promote phosphaturia. Serum FGF23 concentration is considered an early biomarker of excess phosphate load and high levels of FGF23 have been associated with increased mortality. In the present study, we have evaluated the changes in plasma FGF23 after treatment with the phosphate binder lanthanum carbonate in patients with CKD-3 and a normal serum phosphate concentration. METHODS: Eighteen Caucasian CKD Stage 3a/3b patients with serum phosphate <4.5 mg/dL were recruited in a prospective longitudinal open-label study. Patients received a 4-week period of standardized phosphorus-restricted diet containing 0.8 g/Kg/day protein. Thereafter, the same diet was maintained and patients received lanthanum carbonate (750 mg with the three main meals) for 4 weeks. RESULTS: No significant changes were observed in serum phosphate, however, lanthanum carbonate significantly decreased urinary excretion of phosphate and fractional excretion of phosphate (P < 0.004). This was accompanied by a significant decrease in carboxyterminal FGF23 (median percent change from baseline -21.8% (interquartile range -4.5, -30%), P = 0.025). No changes were observed in PTH. CONCLUSIONS: In conclusion, lanthanum carbonate reduced phosphate load, as assessed by urinary phosphate excretion, and also reduced plasma FGF23 in CKD-3 patients. This occurs in the presence of unchanged normal serum phosphate levels.

Altered urinary release of inositol phosphoglycan A-type in women with gestational diabetes mellitus.

BACKGROUND/AIMS: The mechanisms underlying overgrowth of adipose tissue in fetuses of women with gestational diabetes mellitus (GDM) are generally unknown. Inositol phosphoglycan A-type (A-IPG), a putative second messenger of insulin, was reported to regulate lipogenesis in adipose tissue. IPGs have recently been shown to increase during normal pregnancy, in maternal and fetal compartments. METHODS: 48 women with GDM and 23 healthy pregnant women were recruited for this cross-sectional study. Levels of A-IPG were assessed enzymatically in urinary specimens and correlated with clinical parameters. RESULTS: A-IPG urinary release was lower in GDM patients (p < 0.01) and correlated positively with BMI (p < 0.01) and negatively with glycaemic control in the diabetic group (postprandial glycaemia and glycated haemoglobin, p < 0.01) in addition to a nearly significant correlation with birth weight (p = 0.08). Furthermore, a lower A-IPG urinary release was found in diabetic subjects with normal fasting glycaemia compared with those with poor fasting glycaemic control (p < 0.05). CONCLUSIONS: An altered A-IPG urinary excretion occurs in GDM with a negative correlation with poor glycaemic control. Our data suggest an interesting potential role of this molecule in maternal metabolic control during pregnancy and, possibly, in fetal growth.

Randomised study of tegafur and oral leucovorin versus intravenous 5-fluorouracil and leucovorin in patients with advanced colorectal cancer.

This randomised, open-label trial compared oral tegafur (FT)/leucovorin (LV) with the intravenous bolus 5-fluorouracil (5-FU)/LV as first-line chemotherapy for advanced colorectal cancer (CRC). Patients were randomised to receive oral FT 750 mg/m2/day for 21 days and LV 15 mg/m2 every 8 h in cycles repeated every 28 days (n=114), or intravenous LV 20 mg/m2 followed by 5-FU 425 mg/m2 daily for 5 days every 4 weeks for 2 cycles, and later every 5 weeks (n=123). Response rate was significantly higher in the FT/LV arm (27%, 95% CI 19-35) than in the 5-FU/LV arm (13%, 95% CI 7-19) (p<0.004). The median time to progression was 5.9 months (95% CI, 5.3-6.5; FT/LV arm) and 6.2 months (95% CI, 5.4-6.9; 5-FU/LV arm). Median overall survival was 12.4 months (95% CI, 10.3-14.5 months; FT/LV arm) and 12.2 months (95% CI, 8.9-15.7 months; 5-FU/LV arm) (p=n.s.; hazard ratio FT/LV:5-FU/LV=1.02). 5-FU/LV showed a higher incidence of grade 3/4 neutropenia (4.1 vs. 0%). Non-hematological toxicities showed similar incidences in the two treatment arms. Oral FT/LV was more active than IV 5-FU/LV in terms of objective response rate with similar overall survival, and with a favorable toxicity profile. This makes FT/LV a valid alternative to the IV 5-FU schedule in CRC patients.

Cost effectiveness of lanthanum carbonate in chronic kidney disease patients in Spain before and during dialysis.

AIMS: In Spain, the first line treatment of hyperphosphatemia in Chronic Kidney Disease (CKD) consists of calcium-based phosphate binders (CB). However, their use is associated with vascular calcification and an increased mortality risk. The aim of this study was to assess the incremental cost-effectiveness of second-line Lanthanum Carbonate (LC) treatment in patients not responding to CB (calcium carbonate and calcium acetate). MATERIAL AND METHODS: A lifetime Markov model was developed considering three health states (predialysis, dialysis and death). Transitions between states and efficacy data were obtained from randomized clinical trials and the European Dialysis and Transplant Association Annual report. Mortality rate was adjusted with the relative risk related to serum phosphorus levels. According to the Spanish healthcare system perspective, only medical direct costs were considered. Dialysis costs (2013 prices in Euros) were obtained from diagnosis-related groups. Drug costs were derived from ex-factory prices, adjusted with 7.5% mandatory rebate. Quality of life estimates were based on a published systematic review. Costs and benefits were discounted at 3%. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. RESULTS: At the end of simulation, costs per patient with LC therapy were 1,169 and 5,044 with CB alone. 4.653 Quality Adjusted Life Years (QALYs) were gained per patient treated with LC, and 4.579 QALYs with CB. CB therapy is dominated by the LC strategy (i.e. lower costs, higher QALYs). Assuming a 30,000/QALY threshold, LC was dominant in 100% of PSA simulations. CONCLUSIONS: LC is a cost-effective second line treatment of hyperphosphatemia in CKD patients irrespective of dialysis status in Spain.

[Spanish Interdisciplinary Committee for Cardiovascular Disease Prevention and the Spanish Society of Cardiology position statement on dyslipidemia management. Differences between the European and American guidelines]. / Posicionamiento del comité español interdisciplinario de prevención cardiovascular y la sociedad española de cardiología en el tratamiento de las dislipemias. divergencia entre las guías europea y estadounidense.

The publication of the 2013 American College of Cardiology/American Heart Association guidelines on the treatment of high blood cholesterol has had a strong impact due to the paradigm shift in its recommendations. The Spanish Interdisciplinary Committee for Cardiovascular Disease Prevention and the Spanish Society of Cardiology reviewed this guideline and compared it with current European guidelines on cardiovascular prevention and dyslipidemia management. The most striking aspect of the American guideline is the elimination of the low-density lipoprotein cholesterol treat-to-target strategy and the adoption of a risk reduction strategy in 4 major statin benefit groups. In patients with established cardiovascular disease, both guidelines recommend a similar therapeutic strategy (high-dose potent statins). However, in primary prevention, the application of the American guidelines would substantially increase the number of persons, particularly older people, receiving statin therapy. The elimination of the cholesterol treat-to-target strategy, so strongly rooted in the scientific community, could have a negative impact on clinical practice, create a certain amount of confusion and uncertainty among professionals, and decrease follow-up and patient adherence. Thus, this article reaffirms the recommendations of the European guidelines. Although both guidelines have positive aspects, doubt remains regarding the concerns outlined above. In addition to using risk charts based on the native population, the messages of the European guideline are more appropriate to the Spanish setting and avoid the possible risk of overtreatment with statins in primary prevention. Full English text available from:www.revespcardiol.org/en.

[Spanish interdisciplinary committee for cardiovascular disease prevention and the spanish society of cardiology position statement on dyslipidemia management. Differences between the European and american guidelines]. / Posicionamiento del Comité Español Interdisciplinario de Prevención Cardiovascular y la Sociedad Española de Cardiología en el tratamiento de las dislipemias. Divergencia entre las guías europea y estadounidense.

The publication of the 2013 American College of Cardiology/American Heart Association guidelines on the treatment of high blood cholesterol has had a strong impact due to the paradigm shift in its recommendations. The Spanish Interdisciplinary Committee for Cardiovascular Disease Prevention and the Spanish Society of Cardiology reviewed this guideline and compared it with current European guidelines on cardiovascular prevention and dyslipidemia management. The most striking aspect of the American guideline is the elimination of the low-density lipoprotein cholesterol treat-to-target strategy and the adoption of a risk reduction strategy in 4 major statin benefit groups. In patients with established cardiovascular disease, both guidelines recommend a similar therapeutic strategy (high-dose potent statins). However, in primary prevention, the application of the American guidelines would substantially increase the number of persons, particularly older people, receiving statin therapy. The elimination of the cholesterol treat-to-target strategy, so strongly rooted in the scientific community, could have a negative impact on clinical practice, create a certain amount of confusion and uncertainty among professionals, and decrease follow-up and patient adherence. Thus, this article reaffirms the recommendations of the European guidelines. Although both guidelines have positive aspects, doubt remains regarding the concerns outlined above. In addition to using risk charts based on the native population, the messages of the European guideline are more appropriate to the Spanish setting and avoid the possible risk of overtreatment with statins in primary prevention.

[Spanish Interdisciplinary Committee for Cardiovascular Disease Prevention and the Spanish Society of Cardiology Position Statement on Dyslipidemia Management. Differences Between the European and American Guidelines]. / Posicionamiento del Comité Español Interdisciplinario de Prevención Cardiovascular y la Sociedad Española de Cardiología en el tratamiento de las dislipemias. Divergencia entre las guías europea y estadounidense.

The publication of the 2013 American College of Cardiology/American Heart Association guidelines on the treatment of high blood cholesterol has had a strong impact due to the paradigm shift in its recommendations. The Spanish Interdisciplinary Committee for Cardiovascular Disease Prevention and the Spanish Society of Cardiology reviewed this guideline and compared it with current European guidelines on cardiovascular prevention and dyslipidemia management. The most striking aspect of the American guideline is the elimination of the low-density lipoprotein cholesterol treat-to-target strategy and the adoption of a risk reduction strategy in 4 major statin benefit groups. In patients with established cardiovascular disease, both guidelines recommend a similar therapeutic strategy (high-dose potent statins). However, in primary prevention, the application of the American guidelines would substantially increase the number of persons, particularly older people, receiving statin therapy. The elimination of the cholesterol treat-to-target strategy, so strongly rooted in the scientific community, could have a negative impact on clinical practice, create a certain amount of confusion and uncertainty among professionals, and decrease follow-up and patient adherence. Thus, this article reaffirms the recommendations of the European guidelines. Although both guidelines have positive aspects, doubt remains regarding the concerns outlined above. In addition to using risk charts based on the native population, the messages of the European guideline are more appropriate to the Spanish setting and avoid the possible risk of overtreatment with statins in primary prevention.

Spanish Interdisciplinary Committee for Cardiovascular Disease Prevention and the Spanish Society of Cardiology Position Statement on Dyslipidemia Management: differences between the European and American Guidelines.

The publication of the 2013 American College of Cardiology/American Heart Association guidelines on the treatment of high blood cholesterol has had a strong impact due to the paradigm shift in its recommendations. The Spanish Interdisciplinary Committee for Cardiovascular Disease Prevention and the Spanish Society of Cardiology reviewed this guideline and compared it with current European guidelines on cardiovascular prevention and dyslipidemia management. The most striking aspect of the American guideline is the elimination of the low-density lipoprotein cholesterol treat-to-target strategy and the adoption of a risk reduction strategy in 4 major statin benefit groups. In patients with established cardiovascular disease, both guidelines recommend a similar therapeutic strategy (high-dose potent statins). However, in primary prevention, the application of the American guidelines would substantially increase the number of persons, particularly older people, receiving statin therapy. The elimination of the cholesterol treat-to-target strategy, so strongly rooted in the scientific community, could have a negative impact on clinical practice, create a certain amount of confusion and uncertainty among professionals, and decrease follow-up and patient adherence. Thus, this article reaffirms the recommendations of the European guidelines. Although both guidelines have positive aspects, doubt remains regarding the concerns outlined above. In addition to using risk charts based on the native population, the messages of the European guideline are more appropriate to the Spanish setting and avoid the possible risk of overtreatment with statins in primary prevention.

Factors Associated with the Selection of First-line Bevacizumab plus Chemotherapy and Clinical Response in HER2-negative Metastatic Breast Cancer: ONCOSUR AVALOX Study.

AIM: To evaluate factors associated with the selection of first-line bevacizumab plus chemotherapy and clinical response in HER2-negative metastatic breast cancer (MBC) in clinical practice in Spain. PATIENTS AND METHODS: All consecutive adult female patients with HER2-negative MBC who had received first-line bevacizumab plus chemotherapy for at least 3 months were enrolled in the present study. RESULTS: A total of 292 evaluable patients were included; 25% had triple-negative breast cancer (TNBC) and 75% had hormone receptor-positive breast cancer (HRPBC). Nearly 40% of patients had ≥3 metastatic sites, mainly located in the bone (48%) and liver (40%). Bevacizumab was mostly combined with paclitaxel (67.1%). ER-positive tumors were only identified as an independent factor associated with the choice of treatment (odds ratio (OR): 0.538; p=0.02). The overall response rate (ORR) was 63.7% (TNBC: 57.5%; HRPBC: 65.9%). Patients aged 36-50 years (OR: 3.03; p=0.028) and those with metastases at sites other than the bone (OR: 0.38; p=0.001) and ≥3 metastatic sites (OR: 1.41; p=0.018) were more likely to achieve objective responses. CONCLUSION: First-line bevacizumab plus chemotherapy, mainly paclitaxel, is an effective and well-tolerated treatment option for HER2-negative MBC, particularly in more aggressive disease.

Docetaxel plus epirubicin is a highly active, well-tolerated, first-line chemotherapy for metastatic breast cancer: results of a large, multicentre phase II study.

PURPOSE: In this multicentre phase II study, the efficacy and safety profile of the combination of docetaxel and epirubicin as first-line chemotherapy for metastatic breast cancer (MBC) were evaluated. METHODS: Epirubicin (75 mg/m(2)) and docetaxel (75 mg/m(2)) were given intravenously once every 3 weeks for six cycles to 133 patients with MBC. RESULTS: The overall clinical response rate was 67% (complete and partial responses were 23% and 44%, respectively). The median time to progression was 10.8 months (95% CI 9.7-12.6) and the median overall survival was 19.5 months. Granulocyte colony-stimulating factor support was administered to 32% of patients and in 22% of cycles. Grade 3/4 neutropenia occurred in 35% of patients and febrile neutropenia in 19%. The most frequent grade 3/4 non-haematological toxicities (as percent of patients) were asthenia (6%), vomiting (5%) and nausea (5%). No patients developed congestive heart failure. CONCLUSIONS: The combination of docetaxel and epirubicin was highly active as first-line treatment for MBC and showed a manageable toxicity profile.