A Before-and-After Study of the Effectiveness of an Antimicrobial Stewardship Program in Critical Care.

We evaluated the use of antimicrobials expressed as defined daily doses (DDDs) per 1,000 patient days and days of therapy (DOT) per 100 occupied bed-days in a intensive care unit (ICU) of a general hospital in Barcelona, Spain, before and after implementation of an antimicrobial stewardship (AMS) program (2007 to 2010 versus 2011 to 2015). The quarterly costs of antimicrobials used in the ICU and its weight in the overall hospital costs of antimicrobials were calculated. The effect of the applied AMS program on DDDs and DOT time series data was analyzed by means of intervention time series analysis. A total of 5,002 patients were included (1,971 for the first [before] period and 3,031 for the second [after] period). The percentage of patients treated with one or more antimicrobials decreased from 88.6 to 77.2% (P < 0.001). DDDs decreased from 246.8 to 192.3 (mean difference, -54.5; P = 0.001) and DOT from 66.7 to 54.6 (mean difference, -12.1; P = 0.066). The mean cost per trimester decreased from €115,543 to €73,477 (mean difference, -42,065.4 euros; P < 0.001), and the percentage of ICU antimicrobials cost with respect to the total cost of hospital antimicrobials decreased from 28.5 to 22.8% (mean difference, -5.59; P = 0.023). Implementation of an AMS program in the ICU was associated with a marked reduction in the use of antimicrobials, with cost savings close to one million euros since its implementation. An AMS program can have a significant impact on optimizing antimicrobial use in critical care practice.

Prevention of Ventilator-Associated Pneumonia: The Multimodal Approach of the Spanish ICU "Pneumonia Zero" Program.

OBJECTIVES: The "Pneumonia Zero" project is a nationwide multimodal intervention based on the simultaneous implementation of a comprehensive evidence-based bundle measures to prevent ventilator-associated pneumonia in critically ill patients admitted to the ICU. DESIGN: Prospective, interventional, and multicenter study. SETTING: A total of 181 ICUs throughout Spain. PATIENTS: All patients admitted for more than 24 hours to the participating ICUs between April 1, 2011, and December 31, 2012. INTERVENTION: Ten ventilator-associated pneumonia prevention measures were implemented (seven were mandatory and three highly recommended). The database of the National ICU-Acquired Infections Surveillance Study (Estudio Nacional de Vigilancia de Infecciones Nosocomiales [ENVIN]) was used for data collection. Ventilator-associated pneumonia rate was expressed as incidence density per 1,000 ventilator days. Ventilator-associated pneumonia rates from the incorporation of the ICUs to the project, every 3 months, were compared with data of the ENVIN registry (April-June 2010) as the baseline period. Ventilator-associated pneumonia rates were adjusted by characteristics of the hospital, including size, type (public or private), and teaching (postgraduate) or university-affiliated (undergraduate) status. MEASUREMENTS AND MAIN RESULTS: The 181 participating ICUs accounted for 75% of all ICUs in Spain. In a total of 171,237 ICU admissions, an artificial airway was present on 505,802 days (50.0% of days of stay in the ICU). A total of 3,474 ventilator-associated pneumonia episodes were diagnosed in 3,186 patients. The adjusted ventilator-associated pneumonia incidence density rate decreased from 9.83 (95% CI, 8.42-11.48) per 1,000 ventilator days in the baseline period to 4.34 (95% CI, 3.22-5.84) after 19-21 months of participation. CONCLUSIONS: Implementation of the bundle measures included in the "Pneumonia Zero" project resulted in a significant reduction of more than 50% of the incidence of ventilator-associated pneumonia in Spanish ICUs. This reduction was sustained 21 months after implementation.

Vitamin D deficiency is associated with poorer satisfaction with diabetes-related treatment and quality of life in patients with type 2 diabetes: a cross-sectional study.

BACKGROUND: In this cross-sectional study, we assessed the possible association of vitamin D deficiency with self-reported treatment satisfaction and health-related quality of life in patients with type 2 diabetes. METHODS: We performed a sub-analysis of a previous study and included a total of 292 type 2 diabetic patients. We evaluated treatment satisfaction and health-related quality of life through specific tools: the Diabetes Treatment Satisfaction Questionnaire and the Audit of Diabetes-Dependent Quality of Life. Vitamin D deficiency was defined as 25 (OH) D serum levels < 15 ng/mL. RESULTS: Multivariable linear regression models were used to estimate the relationship of vitamin D deficiency with both outcomes once adjusted for self-reported patient characteristics. Vitamin D deficiency was significantly associated with the final score of the Diabetes Treatment Satisfaction Questionnaire and the single "diabetes-specific quality of life" dimension of the Audit of Diabetes-Dependent Quality of Life (p = 0.0198 and p = 0.0070, respectively). However, lower concentrations of 25-OH vitamin D were not associated with the overall quality of life score or the perceived frequency of hyperglycaemia and hypoglycaemia. CONCLUSIONS: Our study shows the association between vitamin D deficiency and both the self-reported diabetes treatment satisfaction and the diabetes-specific quality of life in patients with type 2 diabetes.

Blood pressure response to CPAP treatment in subjects with obstructive sleep apnoea: the predictive value of 24-h ambulatory blood pressure monitoring.

The reduction in blood pressure (BP) with continuous positive airway pressure (CPAP) is modest and highly variable. In this study, we identified the variables that predict BP response to CPAP.24-h ambulatory BP monitoring (ABPM), C-reactive protein (CRP), leptin, adiponectin and 24-h urinary catecholamine were measured before and after 6 months of CPAP in obstructive sleep apnoea (OSA) patients.Overall, 88 middle-aged, obese male patients with severe OSA (median apnoea-hypopnoea index 42 events·h-1) were included; 28.4% had hypertension. 62 patients finished the study, and 60 were analysed. The daytime diastolic BP (-2 mmHg) and norepinephrine (-109.5 nmol·day-1) were reduced after CPAP, but no changes in the 24-h BP, night-time BP, dopamine, epinephrine, CRP, leptin or adiponectin were detected. The nocturnal normotension was associated with an increased night-time-BP (+4 mmHg) after CPAP, whereas nocturnal hypertension was associated with a reduction of 24-h BP (-3 mmHg). A multivariate linear regression model showed differential night-time BP changes after CPAP. Specifically, low night-time heart rate (<68 bpm) and BP dipper profile were associated with increased night-time BP and new diagnosis of nocturnal hypertension.Our results suggest that nocturnal hypertension, circadian BP pattern and night-time heart rate could be clinical predictors of BP response to CPAP and support the usefulness of 24-h ABPM for OSA patients before treatment initiation. These results need to be confirmed in further studies.

High Levels of Hemoglobin Promote Carotid Adventitial Vasa Vasorum Neoangiogenesis in Chronic Kidney Disease.

Chronic kidney disease (CKD) patients, characterized by traditional and nontraditional risk factors, are prone to develop atheromatosis and thus cardiovascular events and mortality. The angiogenesis of the adventitial vasa vasorum (aVV) surrounding the carotid has been described as the atheromatosis initiator. Therefore, the aim of the study was to (1) evaluate if the carotid aVV in CKD patients increases in comparison to its physiological value of healthy patients; (2) explore which traditional or nontraditional risk factor including inflammation, bone and mineral metabolism, and anemia could be related to the aVV angiogenesis. CKD patients without previous cardiovascular events (44, stages 3-4; 37, stage 5D) and 65 healthy subjects were compared. The carotid aVV and the intima-media thickness (cIMT) were evaluated by ultrasound. CKD patients at stages 3-4 showed higher aVV of the right carotid artery even after adjusting for age. Importantly, a multiple linear regression model showed hemoglobin levels > 12.5 g/dL as the factor for an estimated higher aVV of the right carotid artery. In conclusion, the association of hemoglobin with higher aVV could suggest the role of high hemoglobin in the higher incidence of adverse cardiovascular outcomes in CKD patients.

Relationship of the adherence to the Mediterranean diet with health-related quality of life and treatment satisfaction in patients with type 2 diabetes mellitus: a post-hoc analysis of a cross-sectional study.

OBJECTIVE: The main aim of this study was to assess the association between adherence to the traditional Mediterranean diet (MedDiet) and health-related quality of life (HRQoL) and treatment satisfaction in patients with type 2 diabetes mellitus (T2DM). METHODS: This cross-sectional study included 294 patients with T2DM (146 with diabetic retinopathy and 148 without retinopathy). HRQoL and treatment satisfaction were assessed with the Audit Diabetes-Dependent Quality of Life and Diabetes Treatment Satisfaction Questionnaires, respectively. Adherence to the MedDiet was evaluated with the relative Mediterranean Diet Score (rMED). The rMED was added to multivariate linear regression models to assess its relative contribution as a quantitative as well as a qualitative variable after recoding to maximize each of the model's coefficients of determination to explain quality of life as well as treatment satisfaction dimensions. RESULTS: The adherence to the Mediterranean diet showed no significant association with the overall quality of life score. However, rMED was associated with some HRQoL dimensions: travels, self-confidence and freedom to eat and drink (p = 0.020, p = 0.015, p = 0.037 and p = 0.015, respectively). Concerning treatment satisfaction, rMED was positively associated with its overall score (p = 0.046), and especially with the understanding of diabetes (p = 0.0004) and treatment recommendation (p = 0.036), as well as with the perceived frequency of hyperglycaemias (p = 0.039). CONCLUSION: Adherence to the Mediterranean diet was associated with greater treatment satisfaction in patients with T2DM. Although we found no association with overall HRQoL, adherence to this dietary pattern was associated with some quality of life dimensions.

Vitamin D deficiency and its association with fatigue and quality of life in advanced cancer patients under palliative care: A cross-sectional study.

BACKGROUND: A normal vitamin D status is required for bones and muscles to maintain their function and structure, but it also contributes to the functional integrity of other multiple physiologic systems in the body. AIM: To assess the relationship of Vitamin D deficiency with health-related quality-of-life issues, fatigue, and physical functioning in advanced cancer patients. DESIGN: This is a cross-sectional study. PATIENTS/SETTINGS: Adults under palliative care, having a locally advanced or metastatic or inoperable solid cancer. RESULTS: Among 30 patients in palliative care with advanced solid cancer, 90% were vitamin D deficient. Serum Vitamin D concentration was positively correlated with patient-reported absence of fatigue (s = 0.49), and physical and functional well-being (s = 0.44 and s = 0.41, respectively, p < 0.01). Fatigue was the symptom with the highest median impact on their lives and was the only one associated with serum vitamin D (p = 0.031), with lower fatigue in patients with vitamin D concentrations in the third tertile. There was no evidence of a direct association between health-related quality of life and vitamin D status. CONCLUSION: The 90% frequency of advanced cancer patients with vitamin D deficiency, together with the positive correlation of vitamin D status with the absence of fatigue and improved physical and functional well-being, points to vitamin D supplementation as a potential therapy to enhance the patient's quality of life.

Prevalence of subclinical atheromatosis and associated risk factors in chronic kidney disease: the NEFRONA study.

BACKGROUND: The causes of the high cardiovascular mortality observed in chronic kidney disease (CKD) are unknown. Here, we report data on prevalence of subclinical atherosclerosis in the NEFRONA population and a stratified multivariate logistic analysis of factors associated with the presence of plaque. METHODS: We analysed 2445 patients with an estimated glomerular filtration rate (eGFR) <60 mL/min (CKD 3: 937; CKD 4-5: 820; CKD 5D: 688) and 559 non-CKD subjects (eGFR >60 mL/min), 18-75 years old, without previous cardiovascular events. An itinerant team of professionals performed carotid and femoral arterial ultrasound. RESULTS: The already high prevalence of plaques in CKD 3 is even higher in more severe CKD. Multivariate logistic analysis showed that, at any CKD stage, age and being male are independently associated with the presence of plaques. In CKD 3, there was a significant interaction of the smoking status and triglycerides levels which were independently associated with the presence of plaque. Furthermore, being diabetic was also associated with the presence of subclinical atherosclerosis. In stage 4-5 there was a significant association with smoking, high phosphate and hsCRP levels. In dialysis patients, being diabetic, having low levels of 25(OH)-vitamin D3 and smoking status also showed a significant association with the presence of plaque. Furthermore, the association of phosphate levels with the presence of subclinical atheromatosis showed a U-shaped curve. CONCLUSIONS: This analysis demonstrates the magnitude of subclinical atheromatous disease in a large CKD population. The patient characteristics associated with the presence of plaque differ in every CKD stage.

A prospective cross-sectional study on quality of life and treatment satisfaction in type 2 diabetic patients with retinopathy without other major late diabetic complications.

BACKGROUND: To assess quality of life and treatment satisfaction in patients with type 2 diabetes mellitus with diabetic retinopathy (DR) using validated instruments, with comparison to patients without DR. METHODS: A prospective cross-sectional study was designed to assess the influence of retinopathy on quality of life and treatment satisfaction in patients with type 2 diabetes mellitus who do not have any other advanced late complications that could interfere with these outcomes. We included 148 patients with DR and 149 without DR, all without other advanced diabetic complications. Quality of life was assessed using the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire, and treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Clinical and treatment variables related to diabetes were also collected. The degree of DR was classified according to the International Clinical Classification System. Multivariate linear regression models were used to model the ADDQoL and DTSQ scores according to sociodemographical and clinical characteristics, and to model the adjusted relationship of DTSQ with ADDQoL. In DR patients, a subanalysis assessed the relationship of these scores with the degree of retinopathy, severity of macular edema, and previous photocoagulation treatment. RESULTS: DR was associated with significantly lower quality of life (p < 0.001), when examining the two general quality of life items and most of the specific domains. Concerning DTSQ, no difference was found in the total score, and only two domains that assess the perception of glycemic control (hyper- and hypoglycemia) showed a worse score in DR (p < 0.001 and p = 0.008, respectively). Quality of life was significantly affected by the severity of DR, and treatment satisfaction was significantly affected by the severity of macular edema. In the multivariate analysis, a significant effect of the interaction between diabetes duration, insulin therapy, and the presence of DR was found for both, ADDQoL and DTSQ. CONCLUSION: In the absence of other major complications, DR has a negative impact on quality of life in patients with type 2 diabetes. Further, treatment satisfaction was not affected by the presence of DR.

Observational multicenter study to evaluate the prevalence and prognosis of subclinical atheromatosis in a Spanish chronic kidney disease cohort: baseline data from the NEFRONA study.

BACKGROUND: Cardiovascular events (CVE) are more prevalent in chronic kidney disease (CKD) than in general population, being the main cause of morbimortality. Specific risk factors related to CKD have been suggested, because traditional factors do not fully explain this increase in cardiovascular disease rates. However, the role of atheromatosis, its pathogenesis and evolution are still unclear. The potential use of diagnostic tests to detect subclinical atheromatosis has to be determined. METHODS: NEFRONA is a prospective multicenter cohort study. 2445 CKD subjects were enrolled from 81 Spanish hospitals and dialysis clinics, from 2010 to 2012. Eligibility criteria included: 18 to 74 years old, CKD stage 3 or higher, and no previous CVE. 559 non-CKD controls were also recruited. Demographical, clinical and analytical data were collected. Carotid and femoral ultrasounds were performed by a single trained team to measure carotid intima-media thickness (cIMT) and detect atheromatous plaques. Ankle-brachial index (ABI) was measured. RESULTS: Differences in age, sex and prevalence and control of cardiovascular risk factors were found between controls and CKD patients. These differences are similar to those described in epidemiological studies.No difference was found regarding cIMT between controls and CKD (when subjects with plaques in common carotid arteries were omitted); earlier CKD stages had higher values. CKD patients had a higher rate of atheromatous plaques, with no difference between stages in the unadjusted analysis. A group of patients had plaques in femoral arteries but were plaque-free in carotid arteries, and would have gone underdiagnosed without the femoral study. The percentage of pathologic ABI was higher in CKD, with higher prevalence in more advanced stages, and a higher rate of ABI >1.4 than <0.9, suggesting more vascular calcification. CONCLUSIONS: NEFRONA is the first large study describing the actual prevalence of subclinical atheromatosis across different CKD stages. There is a very high rate of atheromatous plaques and pathologic ABI in CKD. Prospective data will add important information to the pathogenesis and evolution of atheromatosis in CKD, compared to non-CKD subjects.

A low fractional excretion of Phosphate/Fgf23 ratio is associated with severe abdominal Aortic calcification in stage 3 and 4 kidney disease patients.

BACKGROUND: Vascular calcification (VC) contributes to high mortality rates in chronic kidney disease (CKD). High serum phosphate and FGF23 levels and impaired phosphaturic response to FGF23 may affect VC. Therefore, their relative contribution to abdominal aortic calcification (AAC) was examined in patients CKD stages 3-4. METHODS: Potential risk factors for AAC, measured by the Kauppila Index (KI), were studied in 178 patients. RESULTS: In multivariate linear analysis, AAC associated positively with age, male gender, CKD-stage, presence of carotid plaques (CP) and also with FGF23, but negatively with fractional excretion of phosphate (FEP). Intriguingly, FEP increased with similar slopes with elevations in PTH, with reductions in GFR, and also with elevations in FGF23 but the latter only in patients with none (KI = 0) or mild (KI = 1-5) AAC. Lack of a FEP-FGF23 correlation in patients with severe AAC (KI > 5) suggested a role for an impaired phosphaturic response to FGF23 but not to PTH in AAC. Logistic and zero-inflated analysis confirmed the independent association of age, CKD stage, male gender and CP with AAC, and also identified a threshold FEP/FGF23 ratio of 1/3.9, below which the chances for a patient of presenting severe AAC increased by 3-fold. Accordingly, KI remained unchanged as FEP/FGF23 ratios decreased from 1/1 to 1/3.9 but markedly increased in parallel with further reductions in FEP/FGF23 < 1/3.9. CONCLUSIONS: In CKD 3-4, an impaired phosphaturic response to FGF23 with FEP/FGF23 < 1/3.9 associates with severe AAC independently of age, gender or CP.

Clinical complications after a traumatic brain injury and its relation with brain biomarkers.

We aimed to find out which are the most frequent complications for patients who suffer a traumatic brain injury (TBI) and its relation with brain biomarker levels. We conducted a hospital cohort study with patients who attended the Hospital Emergency Department between 1 June 2018 and 31 December 2020. Different variables were collected such as biomarkers levels after 6 h and 12 h of TBI (S100, NSE, UCHL1 and GFAP), clinical and sociodemographic variables, complementary tests, and complications 48 h and 7 days after TBI. Qualitative variables were analysed with Pearson's chi-square test, and quantitative variables with the Mann-Whitney U test. A multivariate logistic regression model for the existence of complications one week after discharge was performed to assess the discriminatory capacity of the clinical variables. A total of 51 controls and 540 patients were included in this study. In the TBI group, the mean age was 83 years, and 53.9% of the patients were male. Complications at seven days were associated with the severity of TBI (p < 0.05) and the number of platelets (p = 0.016). All biomarkers except GFAP showed significant differences in their distribution of values according to gender, with significantly higher values of the three biomarkers for women with respect to men. Patients with complications presented significantly higher S100 values (p < 0.05). The patient's baseline status, the severity of the TBI and the S100 levels can be very important elements in determining whether a patient may develop complications in the few hours after TBI.

Platelet levels and age are determinants of survival after mild-moderate TBI: A prospective study in Spain.

Introduction: Traumatic brain injury (TBI) is a very important reason for consultation in emergency departments. Methods: A hospital cohort study with patients who attended a hospital emergency department between June 1, 2018 and December 31, 2020 due to TBI was studied. Clinical and sociodemographic variables were recorded. The levels of biomarkers and management variables were used. Qualitative variables were analyzed using Pearson's chi-square test, and quantitative variables using the Mann-Whitney U-test. Survival analyses were performed by fitting a multivariable Cox regression model for patient survival during the follow-up of the study in relation to the patient's characteristics upon admission to the emergency department. Results: A total of 540 patients were included. The mean age was 83 years, and 53.9% of the patients were men. Overall, 112 patients (20.7%) died during the study follow-up. The mortality rate per 100 person-years was 14.33 (11.8-17.24), the most frequent mechanism being falls in the home, with none caused on public roads. The multivariable Cox proportional hazards model showed that survival after TBI was significantly associated with age, S100 levels, Charlson index, patient's institutionalized status, the place where the TBI occurred, and hemoglobin and platelet levels. Discussion: The most common profile for a patient with a TBI was male and aged between 80 and 90 years. The combination of the variables age, Charlson index, place of TBI occurrence, and hemoglobin and platelet levels could offer early prediction of survival in our population independently of TBI severity. With the data obtained, a therapeutic algorithm could be established for patients suffering from mild TBI, allowing the patient to be supervised at home, avoiding futile referrals to emergency services.

Impact of the "Zero Resistance" program on acquisition of multidrug-resistant bacteria in patients admitted to Intensive Care Units in Spain. A prospective, intervention, multimodal, multicenter study.

OBJECTIVE: To assess the impact of a multimodal interventional project ("Zero Resistance") on the acquisition of multidrug-resistant bacteria (MDR-B) during the patient's ICU stay. DESIGN: Prospective, open-label, interventional, multicenter study. SETTING: 103 ICUs. PATIENTS: Critically ill patients admitted to the ICUs over a 27-month period. INTERVENTIONS: Implementation of a bundle of 10 recommendations to prevent emergence and spread of MDR-B in the ICU. MAIN VARIABLE OF INTEREST: Rate of patients acquiring MDR-B during their ICU stay, with differentiation between colonization and infection. RESULTS: A total of 139,505 patients were included. In 5409 (3.9%) patients, 6020 MDR-B on ICU admission were identified, and in 3648 (2.6%) patients, 4269 new MDR-B during ICU stay were isolated. The rate of patients with MDR-B detected on admission increased significantly (IRR 1.43, 95% CI 1.31-1.56) (p<0.001) during the study period, with an increase of 32.2% between the initial and final monthly rates. On the contrary, the rate of patients with MDR-B during ICU stay decreased non-significantly (IRR 0.93, 95% CI 0.83-1.03) (p=0.174), with a 24.9% decrease between initial and final monthly rates. According to the classification into colonization or infection, there was a highly significant increase of MDR-B colonizations detected on admission (IRR 1.69, 95% CI 1.52-1.83; p<0.0001) and a very significant decrease of MDR-B-infections during ICU stay (IRR 0.67, 95% CI 0.57-0.80, p<0.0001). CONCLUSIONS: The implementation of ZR project-recommendations was associated with a significantly reduction an infection produced by MDR-B acquired during the patient's ICU stay.

Perioperative glycaemic control for diabetic patients undergoing surgery.

BACKGROUND: Patients with diabetes mellitus are at increased risk of postoperative complications. Data from randomised clinical trials and meta-analyses point to a potential benefit of intensive glycaemic control, targeting near-normal blood glucose, in patients with hyperglycaemia (with and without diabetes mellitus) being submitted to surgical procedures. However, there is limited evidence concerning this question in patients with diabetes mellitus undergoing surgery. OBJECTIVES: To assess the effects of perioperative glycaemic control for diabetic patients undergoing surgery. SEARCH METHODS: Trials were obtained from searches of The Cochrane Library, MEDLINE, EMBASE, LILACS, CINAHL and ISIS (all up to February 2012). SELECTION CRITERIA: We included randomised controlled clinical trials that prespecified different targets of perioperative glycaemic control (intensive versus conventional or standard care) DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed risk of bias. We summarised studies using meta-analysis or descriptive methods. MAIN RESULTS: Twelve trials randomised 694 diabetic participants to intensive control and 709 diabetic participants to conventional glycaemic control. The duration of the intervention ranged from just the duration of the surgical procedure up to 90 days. The number of participants ranged from 13 to 421, and the mean age was 64 years. Comparison of intensive with conventional glycaemic control demonstrated the following results for our predefined primary outcomes: analysis restricted to studies with low or unclear detection or attrition bias for infectious complications showed a risk ratio (RR) of 0.46 (95% confidence interval (CI) 0.18 to 1.18), P = 0.11, 627 participants, eight trials, moderate quality of the evidence (grading of recommendations assessment, development and evaluation - (GRADE)). Evaluation of death from any cause revealed a RR of 1.19 (95% CI 0.89 to 1.59), P = 0.24, 1365 participants, 11 trials, high quality of the evidence (GRADE).On the basis of a posthoc analysis, there is the hypothesis that intensive glycaemic control may increase the risk of hypoglycaemic episodes if longer-term outcome measures are analysed (RR 6.92, 95% CI 2.04 to 23.41), P = 0.002, 724 patients, three trials, low quality of the evidence (GRADE). Analysis of our predefined secondary outcomes revealed the following findings: cardiovascular events had a RR of 1.03 (95% CI 0.21 to 5.13), P = 0.97, 682 participants, six trials, moderate quality of the evidence (GRADE) when comparing the two treatment modalities; and renal failure also did not show significant differences between intensive and regular glucose control (RR 0.61, 95% CI 0.34 to 1.08), P = 0.09, 434 participants, two trials, moderate quality of the evidence (GRADE). We did not meta-analyse length of hospital stay and intensive care unit (ICU) stay due to substantial unexplained heterogeneity. Mean differences between intensive and regular glucose control groups ranged from -1.7 days to 2.1 days for ICU stay and between -8 days to 3.7 days for hospital stay (moderate quality of the evidence (GRADE)). One trial assessed health-related quality of life in 12/37 (32.4%) of participants in the intervention group and 13/44 (29.5%) of participants in the control group, and did not show an important difference (low quality of the evidence (GRADE)) in the measured physical health composite score of the short-form 12-item health survey (SF-12). None of the trials examined the effects of the interventions in terms of costs. AUTHORS' CONCLUSIONS: The included trials did not demonstrate significant differences for most of the outcomes when targeting intensive perioperative glycaemic control compared with conventional glycaemic control in patients with diabetes mellitus. However, posthoc analysis indicated that intensive glycaemic control was associated with an increased number of patients experiencing hypoglycaemic episodes. Intensive glycaemic control protocols with near-normal blood glucose targets for patients with diabetes mellitus undergoing surgical procedures are currently not supported by an adequate scientific basis. We suggest that insulin treatment regimens, patient- and health-system relevant outcomes, and time points for outcome measures should be defined in a thorough and uniform way in future studies.

Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial.

CONTEXT: Continuous positive airway pressure (CPAP) is the first-line treatment for patients with symptomatic obstructive sleep apnea (OSA). However, its indication for all patients with sleep-disordered breathing, regardless of daytime symptoms, is unclear. OBJECTIVE: To evaluate the effect of CPAP treatment on the incidence of hypertension or cardiovascular events in a cohort of nonsleepy patients with OSA. DESIGN, SETTING, AND PATIENTS: Multicenter, parallel-group, randomized controlled trial in 14 teaching hospitals in Spain. Between May 2004 and May 2006, 725 consecutive patients were enrolled who had an apnea-hypopnea index of 20 h(-1) or greater and an Epworth Sleepiness Scale score of 10 or less (scores range from 0-24, with values <10 suggesting no daytime sleepiness). Exclusion criteria were previous cardiovascular event, physical or psychological incapacity, chronic disease, or drug or alcohol addiction. Follow-up ended in May 2009. INTERVENTION: Patients were allocated to receive CPAP treatment or no active intervention. All participants received dietary counseling and sleep hygiene advice. MAIN OUTCOME MEASURES: Incidence of either systemic hypertension (taking antihypertensive medication or blood pressure greater than 140/90 mm Hg) or cardiovascular event (nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, hospitalization for unstable angina or arrhythmia, heart failure, or cardiovascular death). RESULTS: Seven hundred twenty-three patients underwent follow-up for a median of 4 (interquartile range, 2.7-4.4) years (1 patient from each group did not receive allocated treatment); 357 in the CPAP group and 366 in the control group were included in the analysis. In the CPAP group there were 68 patients with new hypertension and 28 cardiovascular events (17 unstable angina or arrhythmia, 3 nonfatal stroke, 3 heart failure, 2 nonfatal myocardial infarction, 2 transient ischemic attack, 1 cardiovascular death). In the control group there were 79 patients with new hypertension and 31 cardiovascular events (11 unstable angina or arrhythmia, 8 nonfatal myocardial infarction, 5 transient ischemic attack, 5 heart failure, 2 nonfatal stroke). The hypertension or cardiovascular event incidence density rate was 9.20 per 100 person-years (95% CI, 7.36-11.04) in the CPAP group and 11.02 per 100 person-years (95% CI, 8.96-13.08) in the control group. The incidence density ratio was 0.83 (95% CI, 0.63-1.1; P = .20). CONCLUSIONS: In patients with OSA without daytime sleepiness, the prescription of CPAP compared with usual care did not result in a statistically significant reduction in the incidence of hypertension or cardiovascular events. However, the study may have had limited power to detect a significant difference. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00127348.

A Simple Scoring System to Differentiate Bacterial from Viral Infections in Acute Exacerbations of COPD Requiring Hospitalization.

Objective: Both bacteria and viruses may cause acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The objective of this study was to identify readily available clinical parameters to discriminate between them. Methods: During a winter period all consecutive patients with an AECOP who were hospitalized in a non-ICU general ward were prospectively enrolled. In addition to blood tests, cultures of spontaneous or induced sputum samples, and genome detection of respiratory viruses in nasopharyngeal swab samples using multiplex RT-PCR assays were obtained. Only patients with positive microbiological results (bacteria, virus, or both) were eventually included. Mixed infections (bacteria plus viruses) were categorized into the bacterial group due to therapeutic implications (ie, need for antibiotics). Demographic and routine clinical and analytical information was collected. Results: A total of 127 AECOPD patients out of 213 initially evaluated met inclusion criteria and were classified as having bacterial (70, 55.1%) or viral (57, 44.9%) infection. Although no single variable was useful to identify bacteria, the combination of serum C-reactive protein >70 mg/L (2 points), >1 day of symptoms (1.5 points), and a blood neutrophil count >9,500 x109/L (1 point) into a scoring system reached an AUC of 0.80 (95% CI=0.73-0.88) for bacterial etiologies. With this model, scoring 0 or 1 point significantly reduced the probability of a bacterial infection (likelihood ratio negative of 0.2), whereas summing up 2.5 points or more increased it sufficiently to be clinically meaningful (likelihood ratio positive >3.7). Viral infections resulted in fewer hospitalization days (78.9% of patients spent ≥3 days in hospital vs 95.7% of those with bacterial infections; P=0.008). Conclusion: A simple and easy to obtain score system can help clinicians in the decision of prescribing antibiotics in AECOPD patients.

Correction: Martinez-Gonzalez et al. Adaptation and Validation of the Diabetic Foot Ulcer Scale-Short Form in Spanish Subjects. J. Clin. Med. 2020, 9, 2497.

In the original publication [...].

Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO Study): A Single-Arm Proof-of-Concept Trial.

The aim of this study was to assess the acceptability and feasibility of offering risk-based breast cancer screening and its integration into regular clinical practice. A single-arm proof-of-concept trial was conducted with a sample of 387 women aged 40-50 years residing in the city of Lleida (Spain). The study intervention consisted of breast cancer risk estimation, risk communication and screening recommendations, and a follow-up. A polygenic risk score with 83 single nucleotide polymorphisms was used to update the Breast Cancer Surveillance Consortium risk model and estimate the 5-year absolute risk of breast cancer. The women expressed a positive attitude towards varying the frequency of breast screening according to individual risk and, especially, more frequently inviting women at higher-than-average risk. A lower intensity screening for women at lower risk was not as welcome, although half of the participants would accept it. Knowledge of the benefits and harms of breast screening was low, especially with regard to false positives and overdiagnosis. The women expressed a high understanding of individual risk and screening recommendations. The participants' intention to participate in risk-based screening and satisfaction at 1-year were very high.

[Informed choice in breast cancer screening: the role of education]. / Elección informada en el cribado del cáncer de mama: el papel del nivel educativo.

OBJECTIVE: To evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. METHOD: Secondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary outcome was informed choice defined as adequate knowledge and consistency between attitudes and intentions. RESULTS: The intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups. CONCLUSIONS: A decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened.