Adherence to a priori dietary indexes and baseline prevalence of cardiovascular risk factors in the PREDIMED-Plus randomised trial.

PURPOSE: Cardiovascular disease remains the global leading cause of death. We evaluated at baseline the association between the adherence to eight a priori high-quality dietary scores and the prevalence of individual and clustered cardiovascular risk factors (CVRF) in the PREDIMED-Plus cohort. METHODS: All PREDIMED-Plus participants (6874 men and women aged 55-75 years, with overweight/obesity and metabolic syndrome) were assessed. The prevalence of 4 CVRF (hypertension, obesity, diabetes, and dyslipidaemia), using standard diagnoses criteria, were considered as outcomes. The adherence to eight a priori-defined dietary indexes was calculated. Multivariable models were fitted to estimate differences in mean values of factors and prevalence ratios for individual and clustered CVRF. RESULTS: Highest conformity to any dietary pattern did not show inverse associations with hypertension. The modified Mediterranean Diet Score (PR = 0.95; 95% CI 0.90-0.99), Mediterranean Diet Adherence Score (MEDAS) (PR = 0.94; 95% CI 0.89-0.98), the pro-vegetarian dietary pattern (PR = 0.95; 95% CI 0.90-0.99) and the Alternate Healthy Eating Index 2010 (PR = 0.92; 95% CI 0.87-0.96) were inversely associated with prevalence of obesity. We identified significant inverse trend among participants who better adhered to the MEDAS and the Prime Diet Quality Score (PDQS) in the mean number of CVRF across categories of adherence. Better adherence to several high-quality dietary indexes was associated with better blood lipid profiles and anthropometric measures. CONCLUSIONS: Highest adherence to dietary quality indexes, especially Mediterranean-style and PDQS scores, showed marginal associations with lower prevalence of individual and clustered CVRF among elderly adults with metabolic syndrome at high risk of cardiovascular disease.

[The PROPRESE trial: results of a new health care organizational model in primary care for patients with chronic coronary heart disease based on a multifactorial intervention]. / El estudio PROPRESE: resultados de un nuevo modelo organizativo en atención primaria para pacientes con cardiopatía isquémica crónica basado en una intervención multifactorial.

OBJECTIVE: Comparison 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. METHODS: In 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. RESULTS: The 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. CONCLUSIONS: An 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.

Physician patient communication failure facilitates medication errors in older polymedicated patients with multiple comorbidities.

OBJECTIVE: To analyse the frequency of mistakes in communication between the physician and the patient and their incidence in errors in self-administered drugs. METHODS: We undertook a descriptive, cross-sectional study based on interviews with a random sample of patients older than 65 years who were polymedicated (five or more drugs) and had multiple comorbidities. Data were analysed about the patients' reports of what the physician said, medication mistakes by the patients and their consequences. RESULTS: Responses were provided by 382 patients. A medication error in the last year was reported by 287 patients (75%), and 16 patients (4%) reported four or more errors. Most cases concerned the dosage, a similar appearance of the medication or a lack of understanding of the physician's instructions. Very severe consequences occurred in 19 cases (5%). Multiple comorbidities (P = 0.006) and a greater number of treatments (P = 0.002) were associated with making mistakes. Frequent changes in prescription (P = 0.02), not considering the prescriptions of other physicians (P = 0.01), inconsistency in the messages (P = 0.01), being treated by various different physicians at the same time (P = 0.03), a feeling of not being listened to (P < 0.001) or loss of trust in the physician (P < 0.001) were associated with making medication mistakes. CONCLUSIONS: Mistakes by polymedicated patients with multiple comorbidities represent a real risk that should be addressed by the professionals. A review should be made of the routine control questions that the physician asks the patient to identify what other drugs the patient may be taking that have been indicated by another physician.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial.

BACKGROUND: To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. METHODS/DESIGN: Experimental study. Randomized clinical trial. Follow-up period: one year. STUDY SETTING: primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. DISCUSSION: This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. TRIAL REGISTRATION: NCT01826929.

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.

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.

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.

Clinical inertia in diagnosis and treatment of hypertension in primary care: quantification and associated factors.

OBJECTIVES: The objective of the present study was to quantify both diagnostic and therapeutic inertia in hypertension and to identify patient-associated variables. PATIENTS AND METHODS: Cross-sectional, multicenter study of 35 424 subjects carried out in 428 health centers and/or primary care clinics in the Valencian Community, Spain, in a preventive activity conducted during 2003 and 2004. Diagnostic inertia was identified when a patient without known hypertension had high blood pressure (BP) but was labeled "normal" by the medical staff, and therapeutic inertia when treatment was not modified for a hypertensive patient on the presence of high BP values. Bivariate and multivariate statistical analyses were performed to identify patient's characteristics associated with inertia. RESULTS: Diagnostic inertia was present in 32.5% (95% CI 31.4-33.6) and therapeutic inertia in 37.0% (95% CI 35.6-38.5) of the cases. Both were more frequent in cases of isolated systolic or diastolic high BP. In the multivariate models, the factors associated with diagnostic inertia were type-2 diabetes (p=0.041), non-smoking (p=0.004), previous coronary heart disease (p=0.001), BP values (p<0.001) and body mass index (p=0.031), whereas for therapeutic inertia they were type-2 diabetes (p=0.003), previous coronary heart disease (p=0.016) or stroke (p<0.001) and BP values (p<0.001). CONCLUSIONS: Clinical inertia, either diagnostic or therapeutic, was present in one of every three cases of high BP. The most frequent factors associated with clinical inertia were the presence of associated conditions, which requires lower BP goals and the BP values.

Clinical applicability and cost-effectiveness of DIABSCORE in screening for type 2 diabetes in primary care.

AIMS: To evaluate the applicability and cost-effectiveness of a clinical risk score (DIABSCORE) to screen for type 2 diabetes in primary care patients. METHODS: Multicenter cross-sectional study of 10,508 adult no previously diagnosed with diabetes, in 2 Spanish regions (Canary Islands and Valencian Community). The variables comprising DIABSCORE were age, waist to height ratio, family history of diabetes and gestational diabetes. ROC curves were obtained; the diabetes prevalences odds ratios (HbA1c ≥6.5%) between patients exposed and not exposed to DIABSCORE ≥100, and to fasting blood glucose ≥126mg/dL were calculated. The opinions of both the professionals and the patients concerning DIABSCORE were collected, and a cost-effectiveness analysis was performed. RESULTS: In both regions, the valid cut-off point for diabetes (DIABSCORE=100), showed an area under the curve >0.80. The prevalences odds ratio of diabetes for DIABSCORE ≥100 was 9.5 (3.7-31.5) in Canarian and 18.3 (8.0-51.1) in Valencian; and for glucose ≥126mg/dL it was, respectively, 123.0 (58.8-259.2) and 303.1 (162.5-583.8). However, glucose ≥126mg/dL showed a low sensitivity (below 48% in both communities) as opposed to DIABSCORE ≥100 (above 90% in both regions). Professionals (100%) and patients (75%) satisfaction was greater when using DIABSCORE rather than glucose measurement for diabetes screening. The cost of each case of diabetes identified was lower with DIABSCORE ≥100 (7.6 € in Canarian and 8.3 € in Valencian) than glucose ≥126mg/dL (10.8 € and 10.5 €, respectively). CONCLUSIONS: DIABSCORE is an applicable and cost-effective screening method for type 2 diabetes in primary care.

Non-compliance and inertia in hypertensive Spaniards at high cardiovascular risk: CUMPLE study.

OBJECTIVE: To assess non-compliance (NC) and therapeutic inertia (TI) after 6 months of follow-up in hypertensive patients with poorly controlled blood pressure and high cardiovascular risk. RESEARCH DESIGN AND METHODS: Longitudinal, multicentre study; 3900 uncontrolled hypertensive patients were recruited from 585 primary healthcare centres. Tablets were counted during visits at baseline, 1, 3 and 6 months. A tablet count between 80-100% was considered as compliant. Multivariate logistic regression was performed to determine variables associated with NC and TI. RESULTS: A total of 3636 patients completed, mean age was 64.8 (SD 10.8) years, 53.7% being male. After one month, 61.8% (60.2-63.4) had uncontrolled blood pressure, 39.5% (37.9-41.1) were NC and 52.3% (50.2-54.4) had TI. At the end of follow-up, uncontrolled blood pressure was 34.6% (33.1-36.1) (p < 0.05), NC was 46.8% (45.2-48.4) (p < 0.05) and TI was 34.2% (31.6-36.8) (p < 0.05). The variable associated with NC was greatest number of antihypertensive treatments (OR 1.09, 95% CI 1.05-1.13, p < 0.001), and variables associated with TI were least number of antihypertensive drugs (OR 0.88, 95% CI 0.84-0.98, p < 0.001) and least number of diseases suffered (OR 0.95, 95% CI 0.92-0.98, p = 0.002). LIMITATIONS: Due to the complexity of measuring compliance, we have to assume measurement bias. CONCLUSIONS: Among uncontrolled hypertensive patients, after completing 6 months follow-up, approximately one out of two patients were NC and one out of three physicians committed TI.

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 reasons for it. METHODS: An observational, cross-sectional, multi-center study was carried out in a primary care setting. We included 512 physicians, with a consecutive sampling of 1,499 hypertensive patients with clinical inertia. MAIN OUTCOME MEASURE: Clinical inertia was defined when physicians did not modify treatment despite knowing that the therapeutic target had not been reached. Clinical inertia was considered to be justified (JCI) when physicians provided an explanation for not intensifying treatment and as not justified (nJCI) when no reasons were given. RESULTS: JCI was observed in 30.1 % (95 % CI 27.8-32.4) of patients (n = 451) and nJCI in 69.9 % (95 % CI 67.6-72.2) (n = 1,058). JCI was associated with higher blood pressure (BP) values (both systolic and diastolic) and diabetes (p = 0.012) than nJCI. nJCI was associated with patients having an isolated increase of systolic or diastolic or high borderline BP values or cardiovascular disease. CONCLUSION: Physicians provided reasons for not intensifying 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 cardiovascular disease.

Is there a predictive profile for clinical inertia in hypertensive patients? An observational, cross-sectional, multicentre study.

BACKGROUND: Some studies have described a large number of hypertensive patients who are followed by a primary care physician without achieving adequate blood pressure (BP) control but whose treatment nevertheless is not intensified. It is not known whether physicians are aware of this clinical inertia and what factors are associated with this problem. OBJECTIVE: The aim of this study was to describe the factors associated with clinical inertia in hypertensive patients. METHODS: This was an observational, cross-sectional, multicentre study conducted in a network of primary care centres and hospital hypertension units in Spain. Using a consecutive sampling approach, 512 physicians selected 5077 hypertensive patients in whom they suspected poor BP control after chart review. The main variables documented were BP control and cardiovascular risk according to European Society of Hypertension guidelines, changes in treatment after visit, type of treatment, and healthcare setting. A binomial logistic regression multivariate analysis, adjusted for physician, was performed. RESULTS: Of the selected patients, 70.9% had poor BP control according to measurements taken in the physician's office, and in 1499 (42.1%) of those poorly controlled patients, treatment was not intensified (clinical inertia). Factors associated with clinical inertia were as follows: being seen at a primary care centre (p < 0.001), not having left ventricular hypertrophy (p < 0.001) or microalbuminuria (p < 0.001), taking fixed-dose (p = 0.049) or free-dose (p = 0.001) combination therapy, BP measured in other settings (nurse's office, patient's home) than the physician's office (p = 0.034) or the pharmacy (p = 0.019), older age (p = 0.032), and lower systolic (p < 0.001) and diastolic (p < 0.001) BP. Of the hypertensive patients with clinical inertia, 90.2% (95% CI 88.7, 91.7) had high cardiovascular risk. CONCLUSIONS: Clinical inertia was associated with a profile that included older age, lack of co-morbid conditions and being seen at a primary care centre.

Determinant factors of osteoporosis patients' reported therapeutic adherence to calcium and/or vitamin D supplements: a cross-sectional, observational study of postmenopausal women.

BACKGROUND: Among the various treatments for osteoporosis, calcium and/or vitamin D supplements are frequently included. OBJECTIVE: The objective of the study was to analyse adherence to calcium and/or vitamin D treatment and to identify related predictors of non-adherence in a sample of postmenopausal women treated for osteoporosis in primary care. METHODS: A cross-sectional, observational study was conducted in a sample of postmenopausal women receiving pharmaceutical treatment for osteoporosis with vitamin D and/or calcium. Sociodemographic, general and osteoporosis-related data were collected. Patient's perceptions of the adverse effects of treatment, their knowledge of osteoporosis (Batalla test), their attitude towards treatment (Morisky-Green test) and their self-reported therapeutic adherence (Haynes-Sackett test) were assessed. RESULTS: Of 630 women (mean age +/- SD 64.1 +/- 8.7 years) evaluated, 36.2% (95% CI 32.4, 39.9) had problems with treatment tolerability, 63.5% (95% CI 59.7, 67.3) had good knowledge of osteoporosis, 20.5% (95% CI 17.3, 23.6) had a good attitude to treatment and 50.0% (95% CI 46.1, 53.9) had good self-reported adherence to treatment. Patients in the poor adherence group had higher mean body mass index (p = 0.014), more concurrent pathologies (p = 0.003), more tolerability problems (p < 0.001) and worse attitude to treatment (p < 0.001). The multivariate model showed a positive relationship between therapeutic adherence and good attitude to treatment (odds ratio [OR] = 11.7; p < 0.001), not having tolerability problems (OR = 3.3; p < 0.001) and no polymedication (OR = 0.80; p = 0.017). CONCLUSIONS: Only one in two postmenopausal women with osteoporosis who take calcium and/or vitamin D have good self-reported therapeutic adherence to this treatment. Determinant factors of adherence to calcium and/or vitamin D treatment were patient's attitude to the treatment, tolerability problems with the treatment and number of concurrent treatments.