El estudio PROPRESE: resultados de un nuevo modelo organizativo en atención primaria para pacientes con cardiopatía isquémica crónica basado en una intervención multifactorial

ResumenObjetivoComparando los resultados obtenidos en los estudios EUROASPIRE I y EUROASPIRE III en pacientes con cardiopatía isquémica se muestra que el grado de control de los factores de riesgo mayores es mejorable. El objetivo de este estudio es evaluar la eficacia de una intervención multifactorial orientada a la mejora del grado de control en estos pacientes en el ámbito de la atención primaria.MétodosEn este estudio de intervención aleatorizado, con 1 año de seguimiento, se reclutó a pacientes con diagnóstico de cardiopatía isquémica (145 en el grupo de intervención y 1.461 en el grupo control). Se aplicó una intervención organizativa mixta basada en la mejora de la relación profesional sanitario-paciente (de acuerdo a los modelos del Chronic Care, el Stanford Expert Patient Programme y el Kaiser Permanente) y en la formación profesional continuada. Los principales resultados fueron el efecto sobre el tabaquismo, el colesterol unido a lipoproteínas de baja densidad (cLDL), la presión arterial sistólica (PAS) y la presión arterial diastólica (PAD) a través de un análisis multivariable.ResultadosLas características de los pacientes fueron: edad (68,4±11,8 años), varones (71,6%), diabetes mellitus (51,3%), dislipemia (68,5%), hipertensión arterial (76,7%), no fumadores (76,1%); cLDL < 100mg/dl (46,9%); PAS < 140mmHg (64,5%); PAD < 90 (91,2%). El análisis multivariable mostró que el riesgo para el buen control en el grupo de intervención fue tabaquismo, riesgo relativo ajustado (RRa): 15,7 (intervalo de confianza del 95% [IC95%], 4,2–58,7); p < 0,001; cLDL, RRa: 2,98 (IC95%, 1,48–6,02); p < 0,002; PAS, RRa: 1.97 (IC95%, 1,21–3,23); p < 0,007, y PAD; RRa: 1,51 (IC95%, 0,65–3,50); p < 0,342.ConclusionesUna intervención multifactorial basada en el modelo de paciente crónico centrada en atención primaria y que facilite la toma de decisiones compartidas con los pacientes y la formación de los profesionales mejora el grado de control de los factores de riesgo cardiovascular (tabaquismo, cLDL y PAS). Las estrategias de mejora en la atención de la cronicidad pueden ser una herramienta eficaz para conseguir mejores resultados.AbstractObjectiveComparison of the results from the EUROASPIRE I to the EUROASPIRE III, in patients with coronary heart disease, shows that the prevalence of uncontrolled risk factors remains high. The aim of the study was to evaluate the effectiveness of a new multifactorial intervention in order to improve health care for chronic coronary heart disease patients in primary care.MethodsIn this randomized clinical trial with a 1-year follow-up period, we recruited patients with a diagnosis of coronary heart disease (145 for the intervention group and 1461 for the control group). An organizational intervention on the patient-professional relationship (centered on the Chronic Care Model, the Stanford Expert Patient Programme and the Kaiser Permanente model) and formative strategy for professionals were carried out. The main outcomes were smoking control, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP) and diastolic blood pressure (DBP). A multivariate analysis was performed.ResultsThe characteristics of patients were: age (68.4±11.8 years), male (71.6%), having diabetes mellitus (51.3%), dyslipidemia (68.5%), arterial hypertension (76.7%), non-smokers (76.1%); LDL-C < 100mg/dL (46.9%); SBP < 140mmHg (64.5%); DBP < 90 (91.2%). The multivariable analysis showed the risk of good control for intervention group to be: smoking, adjusted relative risk (aRR): 15.70 (95% confidence interval [95%CI], 4.2–58.7); P < .001; LDL-C, aRR: 2.98 (95%CI, 1.48–6.02); P < .002; SPB, aRR: 1.97 (95%CI, 1.21–3.23); P < .007, and DBP: aRR: 1.51 (95%CI, 0.65–3.50); P < .342.ConclusionsAn intervention based on models for chronic patients focused in primary care and involving patients in medical decision making improves cardiovascular risk factors control (smoking, LDL-C and SBP). Chronic care strategies may be an efficacy tool to help clinicians to involve the patients with a diagnosis of CHD to reach better outcomes

PROSHADE Protocol: Designing and Evaluating a Decision Aid for Promoting Shared Decision Making in Opportunistic Screening for Prostate Cancer: A Mix-Method Study

Background: Opportunistic prostate-specific antigen (PSA) screening may reduce prostate cancer mortality risk but is associated with false positive results, biopsy complications and overdiagnosis. Although different organisations have emphasised the importance of shared decision making (SDM) to assist men in deciding whether to undergo prostate cancer screening, recent evaluations show that the available decision aids fail to facilitate SDM, mainly because they do not consider the patients’ perspective in their design. We aim to systematically develop and test a patient decision aid to promote SDM in prostate cancer screening, following the Knowledge to Action framework. Methods: (1) Feasibility study: a quantitative survey evaluating the population and clinician (urologists and general practitioners) knowledge of the benefits and risks derived from PSA determination and the awareness of the available recommendations. Focus groups to explore the challenges patients and clinicians face when discussing prostate cancer screening, the relevance of a decision aid and how best to integrate it into practice. (2) Patient decision aid development: Based on this data, an evidence-based multicomponent SDM patient decision aid will be developed. (3) User-testing: an assessment of the prototype of the initial patient decision aid through a user-testing design based on mix-methods (questionnaire and semi-structured review). The decision aid will be refined through several iterative cycles of feedback and redesign. (4) Validation: an evaluation of the patient decision aid through a cluster-randomised controlled trial. Discussion: The designed patient decision aid will provide balanced information on screening benefits and risks and should help patients to consider their personal preferences and to take a more active role in decision making. Conclusions: The well-designed patient decision aid (PDA) will provide balanced information on screening benefits and risks and help patients consider their personal preferences.Article funded by the Instituto de Salud Carlos III, Ministry of Science and Innovation of the Government of Spain (Group 26 of the Centro de Investigación Biomédica en Red Epidemiología y Salud Pública, CIBERESP). Research funded by the research project of the Instituto de Salud Carlos III, code PI20/01334, Principal Investigator Dr. Blanca Lumbreras Lacarra, co-financed with FEDER funds from the European Union “A way of doing Europe”

Clinical inertia in poorly controlled elderly hypertensive patients: a cross-sectional study in Spanish physicians to ascertain reasons for not intensifying treatment

Background Clinical inertia, the failure of physicians to initiate or intensify therapy when indicated, is a major problem in the management of hypertension and may be more prevalent in elderly patients. Overcoming clinical inertia requires understanding its causes and evaluating certain factors, particularly those related to physicians. Objective The objective of our study was to determine the rate of clinical inertia and the physician-reported rea- sons for it. Conclusion Physicians provided reasons for not intensi- fying treatment in poorly controlled patients in only 30 % of instances. Main reasons for not intensifying treatment were borderline BP values, co-morbidity, suspected white coat effect, or perceived difficulty achieving target. nJCI was associated with high borderline BP values and car- diovascular diseas

Morbid liver manifestations are intrinsically bound to metabolic syndrome and nutrient intake based on a machine-learning cluster analysis

Metabolic syndrome (MetS) is one of the most important medical problems around the world. Identification of patient ' s singular characteristic could help to reduce the clinical impact and facilitate individualized management. This study aimed to categorize MetS patients using phenotypical and clinical variables habitually collected during health check-ups of individuals considered to have high cardiovascular risk. The selected markers to categorize MetS participants included anthropometric variables as well as clinical data, biochemical parameters and prescribed pharmacological treatment. An exploratory factor analysis was carried out with a subsequent hierarchical cluster analysis using the z-scores from factor analysis. The first step identified three different factors. The first was determined by hypercholesterolemia and associated treatments, the second factor exhibited glycemic disorders and accompanying treatments and the third factor was characterized by hepatic enzymes. Subsequently four clusters of patients were identified, where cluster 1 was characterized by glucose disorders and treatments, cluster 2 presented mild MetS, cluster 3 presented exacerbated levels of hepatic enzymes and cluster 4 highlighted cholesterol and its associated treatments Interestingly, the liver status related cluster was characterized by higher protein consumption and cluster 4 with low polyunsaturated fatty acid intake. This research emphasized the potential clinical relevance of hepatic impairments in addition to MetS traditional characterization for precision and personalized management of MetS patients

Association between ultra-processed food consumption and gut microbiota in senior subjects with overweight/obesity and metabolic syndrome

The production and consumption of ultra-processed foods (UPF) has increased considerably during the last years worldwide. Collective evidence shows the association between UPF consumption and adverse health outcomes, including inflammatory gastro-intestinal disorders and obesity. The gut microbiota has been suggested as potential mediator of the effects of UPF consumption on metabolism and health. However, few studies have been conducted in order to elucidate these aspects. Therefore, the aim of the present study was to assess the cross-sectional associations between UPF consumption and gut microbiota in a population of senior subjects (n = 645) within the frame of the PREDIMED-Plus trial. Eligible participants were men and women (aged 55-75 years), without documented history of cardiovascular disease at enrollment, with overweight/obesity (body mass index ≤ 27 and <40 kg/m2) and metabolic syndrome. Using the information of food frequency questionnaires, the consumption of UPF, expressed as a percentage of total dietary energy intake in kcal/day, was calculated considering those food items classified in group 4 of NOVA system. Population was categorized according to tertiles of UPF consumption. Taxonomic fecal microbiota information, along with blood biochemical parameters, anthropometric measurements and clinical data were obtained. Bioinformatics analysis was performed to study the association between fecal microbiota composition and UPF consumption. We observed that subjects allocated in the highest tertile of UPF consumption (21.4 ± 5.0 % kcal/day) presented lower adherence to MedDiet (p < 0.001) and higher total energy intake (p < 0.001). The taxonomic analysis of the fecal microbiota revealed a significant (Benjamini-Hochberg adjusted p < 0.2) positive association between specific taxa and tertiles (T) of UPF consumption: Alloprevotella (p = 0.041 vs. T2; p = 0.065 vs. T3), Negativibacillus (p = 0.096 vs. T3), Prevotella (p = 0.116 vs. T3), and Sutterella (p = 0.116 vs. T2). UPF consumption was positively associated with lower adherence to MedDiet and higher total energy intake in senior subjects with overweight obesity and metabolic syndrome. In addition, positive association with specific fecal microbiota taxa related to inflammatory gastro-intestinal diseases and low consumption of fruits and vegetables, was observed.This work was supported by the official Spanish Institutions for funding scientific biomedical research, CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN) and Instituto de Salud Carlos III (ISCIII), through the Fondo de Investigación para la Salud (FIS), which is co-funded by the European Regional Development Fund (three coordinated FIS projects leaded by JS-S, including the following projects: PI13/00462, PI16/00501 and PI19/00576); The Generalitat Valenciana PROMETEO 17/2017, PROMETEO 21/2021 and APOSTD/2020/164 (to AÁ-S). This research was also partially funded by EU-H2020 Grant Eat2beNICE/H2020-SFS-2016-2 and by NIH grant R01DK127601. None of the funding sources took part in the design, collection, analysis, interpretation of the data, or writing the report, or in the decision to submit the manuscript for publication. Food companies Hojiblanca (Lucena, Spain) and Patrimonio Comunal Olivarero (Madrid, Spain) donated extra virgin olive oil; and the Almond Board of California (Modesto, CA), American Pistachio Growers (Fresno, CA), and Paramount Farms (Wonderful Company, LLC, Los Angeles, CA) donated nuts for the PREDIMED-Pilot study. AA was supported by the European Union's Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 713679 and from the Universitat Rovira i Virgili (URV). MM was supported by Sara Borrell -CD21/00045- Instituto de Salud Carlos III (ISCIII). IM-I was supported by a Miguel Servet II contract -CPII21-00013- Instituto de Salud Carlos III (ISCIII)