Diabetic foot disease carries an intrinsic high risk of mortality and other severe outcomes in type 2 diabetes: a propensity score-matched retrospective population-based study.

BACKGROUND: To evaluate the association between diabetic foot disease (DFD) and the incidence of fatal and non-fatal events in individuals with type 2 diabetes (T2DM) from primary-care settings. METHODS: We built a cohort of people with a first DFD episode during 2010-2015, followed up until 2018. These subjects were 1 to 1 propensity score matched to subjects with T2DM without DFD. The incidence of all-cause mortality, the occurrence of new DFD, amputations, cardiovascular diseases, or composite outcome, including all-cause mortality and/or cardiovascular events during the follow-up period, were calculated. A Cox proportional hazard analysis was conducted to evaluate the hazard ratios (HR) for different events. RESULTS: Overall, 11,117 subjects with T2DM with a first episode of DFD were compared with subjects without DFD. We observed higher incidence rates (IRs) for composite outcome (33.9 vs. 14.5 IR per 100 person-years) and a new DFD episode event (22.2 vs. 1.1 IR per 100 person-years) in the DFD group. Compared to those without DFD, those with a first episode of DFD had a higher HR for all events, with excess rates particularly for amputation and new DFD occurrence (HR: 19.4, 95% CI: 16.7-22.6, HR: 15.1, 95% CI: 13.8-16.5, respectively) was found. CONCLUSIONS: Although DFD often coexists with other risk factors, it carries an intrinsic high risk of morbidity and mortality in individuals with T2DM. DFD should be regarded as a severe complication already at its onset, as it carries a poor clinical prognosis.

Epidemiology of the first-ever cardiovascular event in people with type 1 diabetes: a retrospective cohort population-based study in Catalonia.

BACKGROUND: Knowledge of the characteristics of first-ever cardiovascular events in type 1 diabetes may impact primary prevention strategies. This study describes the first-ever manifestation of cardiovascular disease (CVD) in patients with type 1 diabetes (T1D) in Catalonia (Spain) and evaluates differences according to age and sex. METHODS: Retrospective cohort study of patients with T1D > 30 years without CVD before 2010 registered in the SIDIAP database. The occurrence of a first cardiovascular event up to the end of 2016, the type of CV event and associations with baseline characteristics were analysed. RESULTS: Of 8412 patients, 884 suffered a first CV event (incidence rate 1.62 per 100 persons-years). Overall, peripheral vascular disease (39.5%) was the most frequent event. We observed a higher proportion of heart failure in women (21.7%) than in men (10.1%). In women, heart failure was the most frequent event in those > 65 years (40.5%). Decreased glomerular filtration rate (hazard ratio [HR] 5.42 [95% CI 4.32;6.80]), elevated albumin/creatinine ratio (HR 3.39 [95% CI [2.47;4.66], microvascular complications (HR 3.27 [95% CI 2.85;3.75]), and hypertension (HR 3.21 [95% CI [2.80;3.67]) were most strongly associated with a first CV event. HbA1c > 7.0% was associated with incident CVD only in patients aged < 55/60 years. CONCLUSIONS: Peripheral artery disease in the whole cohort, and heart failure in elder subjects are the most frequent first-ever CVD events in T1D in our region. These findings deserve to be taken into account when considering primary prevention measures and when estimating CV risk in people with T1D.

Impact of a multicomponent healthcare intervention on glycaemic control in subjects with poorly controlled type 2 diabetes: The INTEGRA study.

AIM: To evaluate whether a specially designed multicomponent healthcare intervention improves glycaemic control in subjects with poorly controlled type 2 diabetes. MATERIALS AND METHODS: A cluster, non-randomized, controlled, pragmatic trial in subjects from 11 primary care centres with type 2 diabetes and HbA1c of more than 9% (> 75 mmol/mol) was conducted. The intervention (N = 225 subjects) was professional and patient-centred, including a dedicated monographic visit that encouraged therapeutic intensification by physicians. The sham control (N = 181) was identical to that of the intervention group except that the dedicated visit was omitted. The primary outcome was to compare the reductions in HbA1c values between the groups at 12 months of follow-up. RESULTS: The mean age at baseline was 59.5 years, mean diabetes duration was 10.7 years and mean HbA1c was 10.3% (89.0 mmol/mol). Patients in the intervention arm achieved significantly greater HbA1c reduction than those in the sham control group at 12 months (mean difference -0.62%, 95% CI = -0.2%, -1.04%; P = .002). A larger percentage of intervention participants achieved an HbA1c of less than 8% (44.8% vs. 25.5%; P = .003) and were more frequently treated with more than three antidiabetic therapies (14.4% vs. 3.5%; P = .0008). Intervention was the only variable associated with higher odds of HbA1c less than 8% (odds ratio = 2.52; 95% CI = 1.54-4.12; P < .001). CONCLUSIONS: A multicomponent intervention including a dedicated visit oriented at reducing therapeutic inertia by primary care physicians can improve glycaemic control in poorly controlled patients with type 2 diabetes.

Association of α-klotho with subclinical carotid atherosclerosis in subjects with type 1 diabetes mellitus.

BACKGROUND: Compelling evidence suggests that the fibroblast growth factor 23 (FGF23) / α-klotho axis is impaired in subjects with diabetes mellitus. We examined the relationship between parameters related to calcium/phosphate homeostasis, including FGF23 and α-klotho, and subclinical carotid atherosclerosis burden in type 1 diabetes mellitus (T1D) subjects. METHODS: This cross-sectional study involved 226 subjects with T1D and 147 age-, sex- and plaque-matched, non-diabetic (non-T1D) subjects, both with normal renal function. Carotid ultrasound was performed to determine the presence and burden of atheromatous plaques. Concentrations of the intact form of FGF23 and α-klotho were assessed by ELISA. Calcium, phosphate, parathyroid hormone, and vitamin D levels were also determined. Negative binomial regression models were used to examine relationship between parameters studied and subclinical carotid atherosclerosis. RESULTS: Only FGF23 was increased in T1D compared with non-diabetic subjects (> 2-fold; p < 0.05). α-klotho was higher in subjects with subclinical carotid atherosclerosis (1.4-fold, p < 0.05). Regression analysis revealed that the log α-klotho concentration was positively associated with the presence of subclinical carotid atherosclerosis both in T1D subjects (incidence rate ratio [IRR]: 1.41; 95% confidence interval [CI], 1.06-1.89; p < 0.05) and in non-T1D subjects (IRR: 1.65; 95% CI, 1.02-2.75; p < 0.05). The models also showed that age, smoking and albuminuria-to-creatinine ratio were positively associated with subclinical carotid atherosclerosis in T1D subjects. Interestingly, sex-related protection against plaque was also revealed in T1D women. CONCLUSION: Higher α-klotho was associated with subclinical carotid atherosclerotic in the absence of kidney dysfunction. This finding also points to a new pathophysiological pathway involved in the development and progression of this complication.

Burden of heart failure in primary healthcare.

OBJECTIVES: To determine the epidemiology of heart failure registered in primary healthcare clinical records in Catalunya, Spain, between 2010 and 2014, focusing on incidence, mortality, and resource utilization. DESIGN: Retrospective observational cohort study. SETTING: Study was carried out in primary care setting. PARTICIPANTS AND INTERVENTIONS: Patients registered as presenting a new heart failure diagnosis. The inclusion period ran from 1st January 2010 to 31st December 2013, but patients were followed until 31st December 2013 in order to analyze mortality. MAIN MEASURES: Information came from electronic medical records. RESULTS: A total of 64441 patients were registered with a new diagnosis of heart failure (2.76 new cases per 1000 persons-year). Among them, 85.8% were ≥65 years. The number of cases/1000 persons-year was higher in men in all age groups. Incidence ranged from 0.04 in women <45 years to 27.61 in the oldest group, and from 0.08 in men <45 years to 28.52 in the oldest group. Mortality occurred in 16305 (25.3%) patients. Primary healthcare resource utilization increased after the occurrence of heart failure, especially the number of visits made by nurses to the patients' homes. CONCLUSION: Heart failure incidence increases with age, is greater in men, and remains stable. Mortality continues to be high in newly diagnosed patients in spite of the current improvements in treatment. Home visits represent the greatest cost for the management of this disease in primary care setting.

Cardiovascular and mortality benefits of sodium-glucose co-transporter-2 inhibitors in patients with type 2 diabetes mellitus: CVD-Real Catalonia.

BACKGROUND: Evidence from prospective cardiovascular (CV) outcome trials in type 2 diabetes (T2DM) patients supports the use of sodium-glucose co-transporter-2 inhibitors (SGLT2i) to reduce the risk of CV events. In this study, we compared the risk of several CV outcomes between new users of SGLT2i and other glucose-lowering drugs (oGLDs) in Catalonia, Spain. METHODS: CVD-REAL Catalonia was a retrospective cohort study using real-world data routinely collected between 2013 and 2016. The cohorts of new users of SGLT2i and oGLDs were matched by propensity score on a 1:1 ratio. We compared the incidence rates and hazard ratio (HR) for all-cause death, hospitalization for heart failure, chronic kidney disease, and modified major adverse CV event (MACE; all-cause mortality, myocardial infarction, or stroke). RESULTS: After propensity score matching, 12,917 new users were included in each group. About 27% of users had a previous history of CV disease. In the SGLT2i group, the exposure time was 60% for dapagliflozin, 26% for empagliflozin and 14% for canagliflozin. The use of SGLT2i was associated with a lower risk of heart failure (HR: 0.59; 95% confidence interval [CI] 0.47-0.74; p < 0.001), all-cause death (HR = 0.41; 95% CI 0.31-0.54; p < 0.001), all-cause death or heart failure (HR = 0.55; 95% CI 0.47-0.63; p < 0.001), modified MACE (HR = 0.62; 95% CI 0.52-0.74; p < 0.001), and chronic kidney disease (HR = 0.66; 95% CI 0.54-0.80; p < 0.001). CONCLUSIONS: In this large, retrospective observational study of patients with T2DM from a Catalonia, initiation of SGLT-2i was associated with lower risk of mortality, as well as heart failure and CKD.

Glycaemic control after treatment intensification in patients with type 2 diabetes uncontrolled on two or more non-insulin antidiabetic drugs in a real-world setting.

AIM: To assess glycaemic control after treatment intensification in patients with type 2 diabetes uncontrolled on ≥2 non-insulin antidiabetic drugs (NIADS). METHODS: A retrospective cohort study, using electronic health records from the SIDIAP database (2010-2014), was conducted. Intensification was defined as the prescription of any new antidiabetic drug in patients treated with ≥2 NIADS and HbA1c >7%. The primary outcome was the absolute change in HbA1c 6-12 months after any intensification. Secondary analyses included the percentage of patients reaching HbA1c <7%, HbA1c <8%, and a reduction of HbA1c >1% after the first intensification. RESULTS: There were 21 241 intensifications in 15 205 patients with a mean (SD) HbA1c of 9.02% (±1.35). Insulin and dipeptidyl peptidase-4 inhibitors (DPP4i) were the most frequently added therapies. The mean baseline-adjusted HbA1c reduction was 0.78% (95% CI, -0.80 to -0.76), varying from -0.69% with DPP4i to -0.85% with glucagon-like peptide-1 receptor agonists while the addition of insulin was associated with a reduction >1%. After the first intensification, 48.9% of patients achieved HbA1c <8%, 16.2% HbA1c <7%, and 43.1% a reduction >1%. High previous HbA1c was positively associated with the reduction of HbA1c >1% [odds ratio (OR) 2.13 (95% CI: 2.05-2.21)], but inversely associated with the attainment of HbA1c <7% [OR 0.64 (0.61-0.67)] or < 8% [OR 0.63 (0.60-0.65)]. Older age, male gender, higher Charlson index, and short diabetes duration were associated with achievement of HbA1c <7%. CONCLUSIONS: Despite intensification, most patients failed the glycaemic goal of HbA1c <7%. The reduction depended mainly on preintensification HbA1c values, with small differences between drugs.

Improved adherence to Mediterranean Diet in adults with type 1 diabetes mellitus.

PURPOSE: We aimed to assess food intake and adherence to the Mediterranean Diet in patients with T1D compared with nondiabetic individuals. METHODS: This was an observational, multicenter study in 262 T1D subjects and 254 age- and sex-matched nondiabetic subjects. A validated food-frequency questionnaire was administered. The alternate Mediterranean Diet Score (aMED) and alternate Healthy Eating Index (aHEI) were assessed. The clinical variables were also collected. The analysis of data included comparisons between groups and multivariate models. RESULTS: Compared to the controls, the patients with T1D had a higher intake of dairy products (p < 0.001), processed meat (p = 0.001), fatty fish (p = 0.009), fruits and vegetables (p < 0.001), nuts (p = 0.011), legumes (p < 0.001), potatoes (p = 0.045), and bread (p = 0.045), and a lower intake of seafood (p = 0.011), sweets (p < 0.001), and alcohol drinks (p = 0.025). This intake pattern resulted in a higher consumption of complex carbohydrates (p = 0.049), fiber (p < 0.001), protein (p < 0.001), polyunsaturated fatty acids (PUFA) (p = 0.007), antioxidants (p < 0.001), vitamins (p < 0.001), and minerals (p < 0.001). The frequency of patients with T1D and low aMED score (23.2%) was lower than that of the controls (35.4%; p = 0.019). The overall multivariate analysis showed that, among other factors, being a T1D subject was associated with improved aMED and aHEI scores (p = 0.006 and p < 0.001). In patients with T1D, residing in a nonurban area was associated with improved aMED and aHEI scores (p = 0.001 and p < 0.001). CONCLUSIONS: Adult patients with T1D showed healthier dietary habits and a higher adherence to the Mediterranean Diet than nondiabetic subjects. Residing in a nonurban area is associated with an improved dietary pattern.

Therapeutic inertia in patients treated with two or more antidiabetics in primary care: Factors predicting intensification of treatment.

AIMS: To determine the patterns and predictors of treatment intensification in patients with type 2 diabetes on ≥2 non-insulin antidiabetic drugs (NIADs) and inadequate glycaemic control in primary care in Catalonia, Spain. MATERIAL AND METHODS: This was a retrospective analysis using electronic medical records from patients with HbA1c ≥ 7% and a first prescription for a new NIAD or insulin recorded from January 2010 to December 2014. Therapeutic inertia was defined as no intensification if HbA1c was ≥8% at baseline or during follow-up. Time to first intensification was evaluated by time-to-event analysis, and factors predicting intensification through a competing-risk regression model. RESULTS: Among 23 678 patients with HbA1c ≥ 7%, 26.2% were censored without treatment intensification after a median follow up of 4.2 years. Among the 12 730 patients in the subgroup with HbA1c ≥ 8% at baseline or during follow-up, therapeutic inertia was present in 18.1% of cases. In the overall cohort, mean HbA1c at initiation of insulin and NIAD were 9.4% ± 1.5% and 8.7% ± 1.3%, respectively. Median time to first intensification was 17.1 months in patients with HbA1c 8.0% to 9.9%, and 10.1 months in those with HbA1c > 10%. Variables strongly associated with intensification were HbA1c values 8.0% to 9.9% (subhazard ratio [SHR], 1.7; 95% CI, 1.65-1.78) and >10% (SHR, 2.5; 95% CI, 2.37-2.68); diabetes duration ≥20 years (SHR, 1.25; 95% CI, 1.11-1.41) and, to a lesser extent, female gender, presence of comorbidities, chronic kidney disease and microvascular complications. CONCLUSIONS: Intensification was not undertaken in 1 in 5 patients. Both HbA1c thresholds and time until therapy intensification exceeded current recommendations.

Safety of cilostazol in peripheral artery disease: a cohort from a primary healthcare electronic database.

BACKGROUND: Cilostazol has been associated with spontaneous reports of cardiovascular adverse events and serious bleeding. The objective of this study is to determine the relative risk of cardiovascular adverse events or haemorrhages in patients with peripheral artery disease treated with cilostazol in comparison to pentoxifylline users. METHODS: Population-based cohort study including all individuals older than 40 who initiated cilostazol or pentoxifylline during 2009-2011 in SIDIAP database. The two treatment groups were matched through propensity score (PS). RESULTS: Nine thousand one hundred twenty-nine patients met inclusion criteria and after PS matching, there were 2905 patients in each group. 76% of patients were men, with similar mean ages in both groups (68.8 for cilostazol and 69.4 for pentoxifylline). There were no differences in bleeding, cerebrovascular and cardiovascular events between both groups. CONCLUSIONS: Patients treated with cilostazol were different from those treated with pentoxifylline at baseline, so they were matched through PS. We did not find differences between treatment groups in the incidence of bleeding or cardiovascular and cerebrovascular events. Cilostazol should be used with precaution in elderly polymedicated patients.

Efficacy and safety of topical application of 15% and 10% potassium hydroxide for the treatment of Molluscum contagiosum.

BACKGROUND/OBJECTIVES: Molluscum contagiosum is the most common skin infection in children. One topical treatment used for Molluscum contagiosum is potassium hydroxide. The objective of this study was to compare the efficacy of potassium hydroxide topical treatment at different concentrations with that of placebo in terms of complete clearing of Molluscum contagiosum lesions and to assess the safety and tolerance of potassium hydroxide topical treatment. METHODS: This was a double-blind randomized clinical trial of three treatments (potassium hydroxide 10%, potassium hydroxide 15%, placebo) applied once daily up to complete clearing of lesions (maximum duration 60 days) in 53 children aged 2-6 years in primary health care pediatric offices in Catalonia, Spain. RESULTS: In the intention-to-treat analysis, potassium hydroxide 10% (58.8%, P = .03) and potassium hydroxide 15% (64.3%, P = .02) had efficacy superior to that of placebo (18.8%). The number of Molluscum contagiosum lesions was significantly reduced with potassium hydroxide 10% and 15%. The main efficacy outcome was achieved in 58.8% of children in the potassium hydroxide 10% group (P = .03 vs placebo) and in 64.3% of children in the potassium hydroxide 15% group (P = .02 vs placebo). Potassium hydroxide 10% and 15% were not significantly different in efficacy from each other. Potassium hydroxide 10% and placebo were better tolerated than potassium hydroxide 15%. No adverse events were reported during the study period. CONCLUSIONS: Potassium hydroxide 10% and 15% demonstrated high rates of efficacy in clearing Molluscum contagiosum lesions, with potassium hydroxide 10% being better tolerated.

Preclinical carotid atherosclerosis in patients with latent autoimmune diabetes in adults (LADA), type 2 diabetes and classical type 1 diabetes.

BACKGROUND: LADA is probably the most prevalent form of autoimmune diabetes. Nevertheless, there are few data about cardiovascular disease in this group of patients. The aim of this study was to investigate the frequency of carotid atherosclerotic plaques in patients with LADA as compared with patients with classic type 1 diabetes and type 2 diabetes. METHODS: Patients with LADA were matched for age and gender in different proportions to patients with type 2 diabetes, and classic type 1 diabetes. None of the patients had clinical cardiovascular disease. All subjects underwent B-mode carotid ultrasound to detect atheroma plaques. Demographics were obtained from all subjects. RESULTS: We included 71 patients with LADA, 191 patients with type 2 diabetes and 116 patients with type 1 diabetes. Carotid atherosclerosis was more frequent in patients with LADA compared with type 2 diabetes (73.2% vs. 56.9%, P = 0.0018) and classic type 1 diabetes (57.1%, P = 0.026); these changes occurred despite healthier macrovascular risk profiles in the former. Age (P < 0.001), smoking (P = 0.003) and hypertension (P = 0.019) were independently associated with carotid atherosclerosis. Multiple plaques were also more frequent in patients with LADA as compared with classic type 1 diabetes and type 2 diabetes (45.1% and 33.6% vs. 27.2%, respectively, P = 0.022). The frequency of carotid plaques increased with increasing diabetes duration in LADA patients compared with type 2 diabetes (85.7% vs. 58.8%, inverse OR 5.72 [1.5-21.8]; P = 0.009). CONCLUSIONS: LADA patients do not present with less carotid atherosclerosis than patients with type 1 and type 2 diabetes. Their macrovascular risk occurs despite a healthier macrovascular risk profile than those patients with type 2 diabetes.

Heart failure labelled patients with missing ejection fraction in primary care: prognosis and determinants.

BACKGROUND: It is common to find a high variability in the accuracy of heart failure (HF) diagnosis in electronic primary care medical records (EMR). Our aims were to ascertain (i) whether the prognosis of HF labelled patients whose ejection fraction (EF) was missing in their EMR differed from those that had it registered, and (ii) the causes contributing to the differences in the availability of EF in EMR. METHODS: Retrospective cohort analyses based on clinical records of HF and attended at 52 primary healthcare centres of Barcelona (Spain). Information of 8376 HF patients aged > 40 years followed during five years was analyzed. RESULTS: EF was available only in 8.5% of primary care medical records. Cumulate incidence for mortality and hospitalization from 1st January 2009 to 31th December 2012 was 37.6%. The highest rate was found in patients with missing EF (HR 1.84, 95% CI 1.68 -1.95) compared to those with preserved EF. Patients hospitalized the previous year and those requiring home healthcare (HR 1.81, 95% Confidence Interval 1.68-1.95 and HR 1.58, 95% CI 1.46-1.71, respectively) presented a higher risk of having an adverse outcome. Older patients, those more socio-economically disadvantaged, obese, requiring home healthcare, and taking loop diuretics were less likely to have an EF registered. CONCLUSIONS: EF is poorly recorded in primary care. HF patients with EF missing at medical records had the worst prognosis. They tended to be older, socio-economically disadvantaged, and more fragile.

[Health literacy in patients with heart failure treated in primary care]. / Alfabetización en salud en pacientes con insuficiencia cardiaca atendidos en atención primaria.

OBJECTIVES: The level of health literacy is examined, as well as its conditioning factors in patients with heart failure who are seen routinely in a Primary Health Care Area. DESIGN: A multicentre cross-sectional study. SETTING: 10 Primary care centres from the metropolitan area of Barcelona. PARTICIPANTS: Patients diagnosed with heart failure. INCLUSION CRITERIA: to have visited the Primary Health Care centre in the last year, being able to arrive at the primary care setting independently, and voluntarily participation. MAIN MEASUREMENTS: Health Literacy Survey-European Union - Questionnaire (HLS-EU-Q) and Spanish version of the European Heart Failure Self-care Behaviour Scale. An analysis was made of the relationships between health literacy, self-care practices, sociodemographic, and clinical variables using ANOVA test and a multiple linear regression model. RESULTS: The study included 318 patients (51.2% women) with a mean age of 77.9±8.7 years. The index of health literacy of 79.6% (n=253) of the participants indicated problems in understanding healthcare information. Health literacy level was explained by academic level (P<.001), the extent of heart failure (P=.032), self-care, and age (P<.04).The academic level explained 61.6% of the health of literacy (95% bootstrap: 44.58%; 46.75%). CONCLUSIONS: In patients with stable heart failure, it is important to consider all factors that help patients to understand the healthcare information. Health literacy explains patient self-care attitude in heart failure.

Monitoring patients on chronic treatment with antidepressants between 2003 and 2011: analysis of factors associated with compliance.

BACKGROUND: Clinical practice guidelines consider the use of antidepressants as one of the standard treatments for anxiety disorders, due to the significant improvements obtained in quality of life and functional disability. In addition, in patients who have not achieved a favorable response after 3 months of psychotherapy, antidepressants are recommended as part of a combined treatment approach. This combination with psychotropic drugs and psychotherapy appears to be indicated from baseline in patients with moderate, severe or recurrent depression. In the last decade, antidepressant prescription rates in general practice have increased between 4 and 10 times. Depression presents high rates of relapse and recurrence. Treatment is often interrupted prematurely, leading to increases in both relapse rates and health care costs. Few studies have analysed the chronic use of antidepressant drugs and long-term adherence. OBJECTIVE: To evaluate compliance with antidepressant treatment between 2003 and 2011 and to explore the associated factors. METHODS: Retrospective cohort study of antidepressant dispensing. SETTING: Health Region of Lleida between 2003 and 2011. PARTICIPANTS: Patients with chronic prescription of antidepressants (ATC code NO6A) during 2003 were followed up until December 2011. The sample comprised 3684 subjects. MAIN MEASURES: The compliance rate was calculated on the basis of the number of units withdrawn from the pharmacy and the theoretical number of units required according to the scheduled duration of treatment: compliance was defined in cases with scores greater than or equal to 80%. RESULTS: 12.5% of patients received chronic antidepressant treatment for at least 4 years. Mean age was 54 years, and 73.2% of patients were female. Almost a third (32.4%) presented anxiety disorders and 26.5% mood disorders. The overall compliance rate was 22% (28% in patients with depression, and 21% in patients with anxiety). According to gender, compliance rates were 21.4% for males and 22.4% for females. Compliance was more likely in patients with polypharmacy. CONCLUSIONS: One in 4 patients complied with treatment. Factors associated with better compliance were polypharmacy and diagnosis of depressive or mixed anxiety-depressive disorder.

Energy expenditure in low active overweight and obese children at varying treadmill grades.

UNLABELLED: This study aimed to evaluate differences between low active overweight and obese children in terms of energy expenditure (EE), ventilation (VE), and cardiac response during graded submaximal treadmill testing at constant speed. METHODS: We categorized 20 children into two weight groups according to the International Obesity Task Force criteria: overweight (n = 10; age = 9.7 ±1.34 years) and obese (n = 10; age = 10.4 ± 1.4 years). Children performed treadmill testing at a constant speed (1.53 m·s-1) and increasing grade (0%, 4%, and 8%). every 3 min. RESULTS: The EE across all grades was significantly higher (p < .001) in obese than in overweight children. Differences at each grade disappeared when EE was adjusted by body mass; however, several differences remained when the EE was adjusted by fat-free mass or body surface area. The increase in EE with increasing grade was greater in obese children (effect size between 0% and 8% for EE was 1.17). BMI z-score and fat mass (kg) were the main predictors of EE (Kcal·min-1) and contributed to explaining 66%, 70%, and 83.4% of the variance in EE at 0%, 4% and 8% gradients respectively. CONCLUSION: We suggest that when assessing EE response to exercise, the degree of obesity should be taken into consideration.

Trends in the prevalence of gestational diabetes in Catalonia from 2010 to 2019.

INTRODUCTION: Gestational diabetes mellitus (GDM) is globally increasing due to changes in risk factors such as gestational age, obesity, and socioeconomic status (SES). This study examined trends of GDM prevalence over ten years using a real-world Primary Health Care database from Catalonia (Spain). METHODS: A retrospective analysis of pregnant women screened for GDM was conducted, using clinical and SES data from the SIDIAP database. RESULTS: Among 221,806 women studied from 2010 to 2019,17,587 had GDM, equating to a 7.9% prevalence (95% CI 7.8-8.04). GDM subjects were older (33.5 ± 5.1 vs. 31.2 ± 5.6 years; p < 0.001) and had higher BMI (29.2 ± 5.1 vs .27.8 ± 4.8 kg/m²; p < 0.001) than non-GDM individuals. Overall GDM prevalence remained unchanged throughout the study, although an increase was observed in younger women (below 20 years: 1.28% [95% CI 0.59-2.42] in 2010 to 2.22% [95% CI 0.96-4.33] in 2019, p = 0.02; ages 20-25.9 years: 3.62% [95% CI 3.12-4.17] in 2010 to 4.63% [95% CI 3.88-5.48)] in 2019, p = 0.02). Age, BMI ≥ 25 kg/m2, deprived SES, and previous hypertension and dyslipidaemia were positively associated with GDM. CONCLUSIONS: This study offers insights into GDM prevalence in Catalonia (Spain),showing overall stability except for a rising trend among younger women.

Sex and age significantly modulate cardiovascular disease presentation in type 2 diabetes: a large population-based cohort study.

Aims: We aimed to describe and compare the incidence of the first cardiovascular event and its major subtypes, coronary heart disease (CHD), cerebrovascular disease, heart failure (HF), or peripheral artery disease (PAD), according to age and sex in a population-based cohort of individuals with type 2 diabetes (T2D) from a Mediterranean region. Material and methods: We used linked primary care electronic medical reports, pharmacy-invoicing data, and hospital admission disease registry records from the SIDIAP database, which contains linked data for 74% of the Catalonian population. We selected individuals with T2D aged 30 to 89 years free of cardiovascular disease (CVD). The primary outcome was the first presentation of CVD. Results: The study cohort included 247,751 individuals (48.6% women, 66.8 ± 11.9 years). During a 6.99-year follow-up, the cumulative incidence of the first cardiovascular event was 23.4%. Men were at higher risk for CVD (hazard ratio [HR]: 1.47 95%CI: 1.45-1.50), CHD (HR: 1.52 95%CI: 1.47-1.57), cerebrovascular disease (HR:1.07 95%CI: 1.03-1.10) and PAD (HR: 2.30 95%CI: 2.21-2.39) than women but at a lower risk for HF (HR:0.70 95%CI: 0.68-0.73). CHD and PAD were the most frequent CVD presentations among men (28.1% and 27.5%) and HF (40.1%) in women. CHD predominated among young participants of both sexes, while HF predominated among women older than 65 and men older than 75. Conclusions: In individuals with T2D, the overall risk and the type of first CVD manifestation largely varied by sex and age. This epidemiological evidence should be considered in clinical practice.

Clinical characteristics and degree of cardiovascular risk factor control in patients with newly-diagnosed type 2 diabetes in Catalonia.

Introduction: Women with type 2 diabetes mellitus (T2DM) face a greater risk of cardiovascular disease (CVD) and encounter challenges in managing cardiovascular risk factors (CVRF); however, limited data are available in individuals with newlydiagnosed T2DM. Methods: This study aimed to examine differences between women and men at the onset of T2DM in terms of clinical characteristics, glycaemic status, and CVRF management. This was a retrospective cohort study including subjects with newly-diagnosed T2DM from the System for the Development of Research in Primary Care (SIDIAP) database in Catalonia (Spain). Sex differences (Dif) were assessed at baseline and 1-year post-diagnosis, by calculating the absolute difference of means or proportions. Results: A total of 13,629 subjects with newly-diagnosed T2DM were analyzed. Women were older and had a higher BMI than men. At baseline, women had higher total cholesterol [Dif (95%CI) 10 mg/dL (9.1/10.8)] and low-density lipoprotein cholesterol (LDL-c) [Dif (95%CI) 7 mg/dL (6.3/7.7)], while men had higher rates of smoking and alcohol intake. Lipid target achievement was lower in women, in both primary prevention (LDL-c < 100 mg/dL) [Dif (95%CI) -7.3 mg/dL (-10.5/-4.1)] and secondary prevention (LDL-c < 70 mg/dL) [Dif (95%CI) -8.3 mg/dL (-17.3/0.7)], along with lower statin and antiplatelet prescriptions, especially one year after diagnosis. Changes in clinical and laboratory data one year post-diagnosis revealed that, in the primary prevention group, men experienced greater improvements in total cholesterol, LDL-c and triglycerides, while women had less success in achieving CVRF control targets compared to men. Additionally, cardiovascular events, such as coronary artery disease and peripheral artery disease increased more in men than in women within the first year of diagnosis, especially in primary prevention subjects. Conclusion: Differences between men and women CVRF are already apparent at the onset of T2DM, particularly in primary prevention, with notable differences in lipid profile and target level attainment.

Clinical Validation of Digital Healthcare Solutions: State of the Art, Challenges and Opportunities.

Digital health technologies (DHTs) at the intersection of health, medical informatics, and business aim to enhance patient care through personalised digital approaches. Ensuring the efficacy and reliability of these innovations demands rigorous clinical validation. A PubMed literature review (January 2006 to July 2023) identified 1250 papers, highlighting growing academic interest. A focused narrative review (January 2018 to July 2023) delved into challenges, highlighting issues such as diverse regulatory landscapes, adoption issues in complex healthcare systems, and a plethora of evaluation frameworks lacking pragmatic guidance. Existing frameworks often omit crucial criteria, neglect empirical evidence, and clinical effectiveness is rarely included as a criterion for DHT quality. The paper underscores the urgency of addressing challenges in accreditation, adoption, business models, and integration to safeguard the quality, efficacy, and safety of DHTs. A pivotal illustration of collaborative efforts to address these challenges is exemplified by the Digital Health Validation Center, dedicated to generating clinical evidence of innovative healthcare technologies and facilitating seamless technology transfer. In conclusion, it is necessary to harmonise evaluation approaches and frameworks, improve regulatory clarity, and commit to collaboration to integrate rigorous clinical validation and empirical evidence throughout the DHT life cycle.