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Aim: To translate and culturally adapt the FRAIL scale into Spanish and perform a preliminary test of diagnostic accuracy in patients admitted to intensive care units. Design: Cross‐sectional diagnostic study. Methods: Five intensive care units (ICU) in Spain were participated. Stage 1: Three native Spanish‐speaking bilingual translators familiar with the field of critical care translated the scale from English into Spanish. Stage 2: Three native English‐speaking bilingual translators familiar with critical care medicine. Stage 3: Authors of the original scale compared the English original and back‐translated versions of the scale. Stage 4: Five nurses with more than 5 years of ICU experience and five critical care physicians assessed the comprehension and relevance of each of the items of the Spanish version in 30 patients of 3 different age ranges (<50, 50–65 and >65 years). Results: The FRAIL scale was translated and adapted cross‐culturally for patients admitted to intensive care units in Spain. The process consisted of four stages: translation, back translation, comparison and pilot test. There was good correspondence between the original scale and the Spanish version in 100% of the items. The participating patients assessed the relevance (content validity) and comprehensibility (face validity) of each of the items of the first Spanish version. The relevance of some of the items scored low when the scale was used in patients younger than 65 years. Conclusions: We have cross‐culturally adapted the FRAIL scale, originally in English, to Spanish for its use in the critical care medical setting in Spanish‐speaking countries. Implications for Professionals: Physicians and nurses can apply the new scale to all patients admitted to the intensive care units. Nursing care can be adapted according to frailty, trying to reduce the side effects of admission to these units for the most fragile patients. Reporting Method: The manuscript's authors have adhered to the EQUATOR guidelines, using the COSMIN reporting guideline for studies on the measurement properties of patient‐reported outcome measures. Patient or Public Contribution: In a pilot clinical study, we applied the first version of the FRAIL‐Spain scale to intensive care unit (ICU) patients. Five nurses with more than 5 years of ICU experience and five critical care physicians assessed the relevance (content validity) and comprehensibility (face validity) of the five items of the first Spanish version. Relevance was assessed using a 4‐point Likert scale ranging from 1 (no relevance) to 4 (high relevance), and comprehensibility was assessed as poor, acceptable or good. Each health professional applied the scale to three patients (total number of patients = 30) of three different age ranges (<50, 50–65 and >65 years) and recorded the time of application of the scale to each patient. Although the frailty scales were initially created by geriatricians to be applied to the elders, there is little experience with their application in critically ill patients of any age. Therefore, more information is needed to determine the relevance of using this scale in critical care patients. In this pilot study, we considered that nurses and critical care physicians should evaluate frailty using this adapted scale in adult patients admitted to the Intensive Care Units. [ABSTRACT FROM AUTHOR]

Background: Men with prostate cancer who undergo radical prostatectomy experience a decrease in quality of life, often related to sexual disfunction and urinary incontinence. Knowing and measuring the impact of radical prostatectomy on the individual's social, emotional, and family quality of life could help to plan and develop an appropriate, patient-centred therapeutic approach. Aim: In this study, we aimed to evaluate changes in quality of life of patients with prostate cancer before and after radical prostatectomy. Methods: A longitudinal, observational study of 114 participants was conducted using the method of test–retest. Quality of life before and after radical prostatectomy was measured through the following self-administered questionnaires: (1) The EORTC QLQ-C30 in its Spanish version was used to assess the generic quality of life the participants; (2) the EORTC QLQ-PR25 in its Spanish version was used to assess the specific, health-related quality of life of prostate cancer patients. Results: A total of 114 men took part in this study. The results from the QLQ-C30 questionnaire indicated an improvement in the dimensions of emotional role and cognitive function, as well as in the symptoms of fatigue, pain, nausea and vomiting, insomnia, and loss of appetite, after surgery. Patients scored lower in the dimensions of role functioning, social function, and economic impact after radical prostatectomy. According to the results from the QLQ-PR25 questionnaire, 61.40% of the participants experienced sexual impotence and 26.31% suffered urinary incontinence after surgery. There were significant differences in some postsurgical outcomes between patients who had neurovascular bundles preserved and those who had not. Conclusions: In-depth knowledge of, and measurement of changes in, quality of life after radical prostatectomy should allow for comprehensive, multidisciplinary, patient-centred care planning. Psychosocial assessment, both before and after surgery, is crucial in patients with prostate cancer. This study was prospectively registered with the CEIC-A on 2012-06-27, with registration number C.P.-C.I. PI12/0088 [ABSTRACT FROM AUTHOR]

Nowadays pulmonary diseases are an increasingly important cause of morbidity and mortality. Diaphragmatic breathing is a controlled-breathing technique that aims to optimize thoracoabdominal movements. The aim of this study was to apply a respiratory and musculoskeletal physiotherapy program in institutionalized older adults and to assess the effects on their pulmonary function tests and oxygen saturation. A randomized double-blind clinical trial was conducted with thirty institutionalized older adults, randomly assigned to a control group (CG), who conducted musculoskeletal exercises; or an experimental group (EG) who, in addition, carried out diaphragmatic breathing, administered for eight weeks, three times/week. Outcomes were pulmonary function variables (forced vital capacity, FVC; forced expired volume at 1 s, FEV1; the FEV1/FVC ratio) and oxygen saturation (SpO2) before and after treatment. Normality of the distributions was tested with Saphiro-Wilk and the pre-post improvement was assessed with a two-sample Mann-Whitney test. Significance level was corrected for multiple comparisons using Benjamini-Hochberg correction (p < 0.04). There was a clinically significant improvement of FVC and FEV1 for the EG. Moreover, the EG showed a statistically significant increase of SpO2 (p = 0.028) after treatment when compared to CG. A physiotherapy program combining breathing and musculoskeletal exercises, improved respiratory parameters in institutionalized older adults. [ABSTRACT FROM AUTHOR]

Objective. The aim of the present work is to analyze certain psychological features in a group of patients diagnosed with Epicrania fugax (EF; that has been recently included in the appendix of the International Classification of Headache Disorders, third edition, beta version), as well as their association with diverse demographic and clinical characteristics of the sample. Design. Case-control. Method. Perceived Stress Scale (PSS), Stress Coping (COPE), Big Five Personality Traits (NEOFFI), Depression (BDI-II), and Trait Anxiety (STAI) were evaluated in 23 patients with EF and 23 matched healthy controls. Differences between EF patients and controls were analyzed using the Mann- Whitney U test. Differences in psychological features as a function of the demographic and clinical characteristics were examined using one-way Analysis of Variance (ANOVA), Mann-Whitney U test, or Pearson's correlations. Results. The two groups differed significantly from each other in Denial, Trait anxiety, and Depression. Low-frequency epicrania patients scored significantly higher than controls in Perceived stress, Neuroticism, Denial, Self-blame, Trait anxiety, and Depression and higher than high-frequency EF in Venting. Conclusions. The results initially suggest the absence of substantial differences between patients suffering of EF and healthy controls. On the contrary, low-frequency EF patients show a distinctive "negative (unhealthy) psychological profile," in opposition to high-frequency EF patients. This circumstance highlights the potential need to consider low- frequency EF patients as a target for psychological intervention in combination with the most common medical procedures. Longitudinal studies are necessary to correctly elucidate the influence of these psychological variables on the course of EF. [ABSTRACT FROM AUTHOR]

Objective. To investigate widespread pressure hyperalgesia in the trigemino-cervical and extra-trigeminal (distant pain-free) regions in women with episodic and chronic migraine. Methods. Fifty-one women with episodic migraine, 52 women with chronic migraine, and 52 healthy women without headache history were recruited. Pressure pain thresholds (PPT) were bilaterally assessed over the trigeminal area (i.e., temporalis muscle), cervical area (i.e., C5/C6 zygapophyseal joint), and two extra-trigeminal areas (i.e., second metacarpal, tibialis anterior muscle) in a blinded design. Clinical features of migraine and anxiety/depression (Hospital Anxiety and Depression Scale, HADS) were also assessed. Results. The multivariate analysis of covariance (ANCOVA) revealed that PPTs were significantly decreased bilaterally over trigeminal and extra-trigeminal points in migraine patients compared to healthy women (all sites, P< 0.001). No differences between episodic and chronic migraine were observed (all, P> 0.919). The presence of neck pain (all, P> 0.282), anxiety (P> 0.425) or depression (all, P> 0.316) did not influence the results. The intensity of migraine pain was negatively associated with widespread pressure pain sensitivity: The greater the intensity of migraine attacks, the lower the widespread PPT levels, i.e., the greater the widespread sensitization. Conclusions. This study found similar widespread pressure hypersensitivity in women with episodic or chronic migraine suggesting that central manifestations are involved both in episodic and chronic migraine. [ABSTRACT FROM AUTHOR]

Background: We aimed to determine the prevalence of consumption of oral contraceptives (OCs) among adolescents and young women living in Spain and to identify the factors associated with this consumption. Methods: We performed a cross-sectional study on the consumption of OCs by women aged 15-30 years residing in Spain. We used secondary individualized data from the 2006 (n = 2513) and 2012 (n = 1530) Spanish National Health Surveys. The dependent variable was the use of OCs in the previous 2 weeks. Independent variables included sociodemographic characteristics, comorbidity, lifestyle, and healthcare resource utilization. The prevalence of OC consumption was analysed by investigating the changes observed between 2006 and 2012. We used multivariate logistic regression to identify the independent factors associated with OC use in each year. Results: In 2006, 14.42 % of women reported using OCs; this percentage dropped to 10.21 % in 2012 (p <0 . 05). Multivariate analysis revealed an association between OC use and visits to the gynaecologist (AOR, 5.60 [95 % CI, 2.93-10.73] in 2006; and AOR, 3.55 [95 % CI, 1.30-9.73] in 2012), Pap smear tests (AOR, 1.8 [95 % CI, 1.23-2.87] in 2006; and AOR, 2.42 [95 % CI, 1.30-4.51] in 2012), and smoking in 2006 (AOR, 1.42 [95 % CI, 1.04-1.93]). Conclusions: There was a significant decrease in OC use from 2006 to 2012 among adolescents and young women living in Spain. In the present study, consumers of OCs were women who visited a gynaecologist more often and complied more with preventive measures such as Pap smear testing. Also, women who reported having used OCs were more likely to smoke than the rest of the study population, although the smoking habit is a risk factor for thrombotic events in women who take OCs. [ABSTRACT FROM AUTHOR]

Background: Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-type diet (MedDiet) in the PREvención con DIeta MEDiterránea (PREDIMED) randomized trial. Methods: Analyses included men and women living in Spain aged 55-80 at high risk for cardiovascular disease. Participants were randomized to the MedDiet supplemented with either complementary extra-virgin olive oil (EVOO) or tree nuts. The control group and participants with insufficient information on adherence were excluded. PREDIMED began in 2003 and ended in 2010. Investigators assessed covariates at baseline and dietary information was updated yearly throughout follow-up. Adherence was measured with a validated 14-point Mediterranean-type diet adherence score. Logistic regression was used to examine associations between baseline characteristics and adherence at one and four years of follow-up. Results: Participants were randomized to the MedDiet supplemented with EVOO (n = 2,543; 1,962 after exclusions) n or tree nuts (n = 2,454; 2,236 after exclusions). A higher number of cardiovascular risk factors, larger waist n circumference, lower physical activity levels, lower total energy intake, poorer baseline adherence to the 14-point adherence score, and allocation to MedDiet + EVOO each independently predicted poorer adherence. Participants from PREDIMED recruiting centers with a higher total workload (measured as total number of persons-years of follow-up) achieved better adherence. No adverse events or side effects were reported. Conclusions: To maximize dietary adherence in dietary interventions, additional efforts to promote adherence should be used for participants with lower baseline adherence to the intended diet and poorer health status. The design of multicenter nutrition trials should prioritize few large centers with more participants in each, rather than many small centers. Trial registration: This study was registered at controlled-trials.com (http://www.controlled-trials. com/ISRCTN35739639). International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005. Trial design: parallel randomized trial. [ABSTRACT FROM AUTHOR]

BACKGROUND: Prenatal exposure to air pollutants has been suggested as a possible etiologic factor for the occurrence of autism spectrum disorder. OBJECTIVES: We aimed to assess whether prenatal air pollution exposure is associated with childhood autistic traits in the general population. METHODS: Ours was a collaborative study of four European population-based birth/child cohorts-- CATSS (Sweden), Generation R (the Netherlands), GASPII (Italy), and INMA (Spain). Nitrogen oxides (NO2, NOx) and particulate matter (PM) with diameters of ≤ 2.5 μm (PM2.5), ≤ 10 μm (PM10), and between 2.5 and 10 μm (PMcoarse), and PM2.5 absorbance were estimated for birth addresses by land-use regression models based on monitoring campaigns performed between 2008 and 2011. Levels were extrapolated back in time to exact pregnancy periods. We quantitatively assessed autistic traits when the child was between 4 and 10 years of age. Children were classified with autistic traits within the borderline/clinical range and within the clinical range using validated cut-offs. Adjusted cohort-specific effect estimates were combined using random-effects meta-analysis. RESULTS: A total of 8,079 children were included. Prenatal air pollution exposure was not associated with autistic traits within the borderline/clinical range (odds ratio = 0.94; 95% CI: 0.81, 1.10 per each 10-μg/m³ increase in NO2 pregnancy levels). Similar results were observed in the different cohorts, for the other pollutants, and in assessments of children with autistic traits within the clinical range or children with autistic traits as a quantitative score. CONCLUSIONS: Prenatal exposure to NO2 and PM was not associated with autistic traits in children from 4 to 10 years of age in four European population-based birth/child cohort studies. [ABSTRACT FROM AUTHOR]

Background: The consumption of prebiotics (fermentable and non-digestible carbohydrates) has been proposed as a potentially protective factor against overweight and obesity. However, to our knowledge, no previous prospective studies have assessed the association between the consumption of prebiotics and the incidence of overweight or obesity. Objective: We evaluated the association between prebiotic consumption [fructans and galacto-oligosaccharides (GOSs)] and the incidence of overweight [body mass index (BMI; in kg/m²) ≥25] in the SUN (Seguimiento Universidad de Navarra) Project, which is a prospective cohort of Spanish, middle-aged university graduates with initial BMI <25. Design: The SUN Project is a dynamic, prospective, multipurpose cohort of Spanish university graduates with an overall retention rate of 90%. The study population encompassed 8569 Spanish university graduates (mean age: 37 y) who were initially free of overweight or obesity. Self-reported weight (previously validated) was collected at baseline and updated every 2 y during the follow-up period. Fructan consumption and GOS consumption were assessed with the use of a validated semiquantitative 136-item food-frequency questionnaire and were updated after 10 y. Time-dependent Cox proportional hazards models were used to estimate HRs and 95% CIs for incident overweight and to adjust for potential confounding factors. Results: During follow-up (median: 9 y), 1964 incident cases of overweight were identified. After potential confounders were adjusted for, risk of overweight was 15% lower in participants in the highest quartile of fructan consumption (≥2.3 g/d) (95% CI: 0.74, 0.97; P-trend = 0.019). Subjects in the highest quartile of GOS consumption (≥0.45 g/d) had 17% lower risk of overweight (95% CI: 0.74, 0.94; P-trend = 0.001). Conclusions: Higher prebiotic consumption was associated with lower risk of overweight in a cohort of initially normal-weight, middle-aged adults. This potential protection has been previously scarcely assessed; therefore, additional longitudinal studies are needed to confirm our results. [ABSTRACT FROM AUTHOR]

Background: Metabolic syndrome (MetS) is an important and priority public health problem globally. Long working hours have been proposed as a modifiable risk factor for MetS, despite sparse epidemiological evidence. Thus, the aim of this study was to prospectively evaluate the associations between working hours and incidence of MetS and each of its components. Methods: We assessed 6845 participants of a Spanish dynamic prospective cohort of university graduates (the SUN project), initially free of any specific criteria of MetS, and followed-up for a median of 8.3 years. Weekly working hours were collected at baseline and grouped into four categories: >0-24, 25-39, 40-49 and ≥50 h. MetS was defined according to the updated harmonizing criteria. We estimated multivariable adjusted Relative Risks (RR) of MetS and their 95% Confidence Intervals (95% CI), using Poisson regression models. Results: The cumulative incidence of MetS was 6.0%. Working hours were not independently related to MetS (25-39 h/week = RR: 1.42, 95% CI 0.90-2.25; 40-49 h/week = RR: 1.45, 95% CI 0.91-2.30; ≥50 h/week = RR: 1.49, 95% CI 0.91-2.42, P for trend = 0.235) nor to any of its individual definition criteria. Conclusion: Our findings do not suggest that long working hours increase the risk of MetS development or each of its components. Further longitudinal studies in general population should be conducted to confirm these results. [ABSTRACT FROM AUTHOR]

Background: Few observational studies have examined the effect of dietary fiber intake and fruit and vegetable consumption on total mortality and have reported inconsistent results. All of the studies have been conducted in general population and typically used only a single assessment of diet. Objective: We investigated the association of fiber intake and whole-grain, fruit, and vegetable consumption with all-cause mortality in a Mediterranean cohort of elderly adults at high cardiovascular disease (CVD) risk by using repeated measurements of dietary information and taking into account the effect of a dietary intervention. Design: We followed up 7216 men (55-75 y old) and women (60-75 y old) at high CVD risk in the Prevención con Dieta Mediterránea (PREDIMED) trial for a mean of 5.9 y. Data were analyzed as an observational cohort. Participants were initially free of CVD. A 137-item validated food-frequency questionnaire administered by dietitians was repeated annually to assess dietary exposures (fiber, fruit, vegetable, and whole-grain intakes). Deaths were identified through the continuing medical care of participants and the National Death Index. An independent, blinded Event Adjudication Committee adjudicated causes of death. Cox regression models were used to estimate HRs of death during follow-up according to baseline dietary exposures and their yearly updated changes. Results: In up to 8.7 y of follow-up, 425 participants died. Baseline fiber intake and fruit consumption were significantly associated with lower risk of death [HRs for the fifth compared with first fifth: 0.63 (95% CI: 0.46, 0.86; P = 0.015) and 0.59 (95% CI: 0.42, 0.82; P = 0.004), respectively]. When the updated dietary information was considered, participants with fruit consumption >210 g/d had 41% lower risk of all-cause mortality (HR: 0.59; 95% CI: 0.44, 0.78). Associations were strongest for CVD mortality than other causes of death. Conclusion: Fiber and fruit intakes are associated with a reduction in total mortality. PREDIMED was registered at controlled-trials.com as ISRCTN35739639. [ABSTRACT FROM AUTHOR]

The incidence of the metabolic syndrome (MetS) is increasing and lifestyle behaviours may play a role. The aim of the present study was to prospectively assess the association between changes in the consumption of sugar-sweetened beverages (SSB) and the incidence of the MetS and its components in a Spanish cohort of university graduates. We included 8157 participants initially free of the MetS and followed up during at least 6 years. SSB consumption was collected by a FFQ previously validated in Spain. The change in SSB consumption was calculated as the difference between SSB consumption at a 6-year follow-up and baseline consumption. The MetS was defined according to the International Diabetes Federation and the American Heart Association/National Heart, Lung, and Blood Institute’s new definition of the MetS that had harmonised previous definitions. The associations between changes in SSB intake and the MetS were examined using multiple logistic regression. We observed 361 incident cases of the MetS. Participants who increased their consumption of SSB (upper v. lower quintile) had a significantly higher risk of developing the MetS (adjusted OR 2·2, 95% CI 1·4, 3·5; P for trend=0·003). Similarly, they presented a significantly higher risk of developing high blood pressure (adjusted OR 1·6, 95% CI 1·3, 2·1), central obesity (adjusted OR 2·3, 95% CI 1·9, 2·7), hypertriacylglycerolaemia (adjusted OR 1·7, 95% CI 1·1, 2·6) or impaired fasting glucose (adjusted OR 1·6, 95% CI 1·1, 2·2). In conclusion, an increase in SSB consumption was associated with a higher risk of developing the MetS and other metabolic disorders after 6 years of follow-up in a Mediterranean cohort of university graduates. [ABSTRACT FROM AUTHOR]

The aims of this study were to measure the effects of a cardiac rehabilitation program based on a modification of a sport (tennis) on quality of life, on various laboratory test parameters and on an exercise stress test, and to determine if the results of this novel activity are equivalent to those of traditional programs (i.e., the use of the bicycle ergometer). The sample consisted of 79 patients with a low-risk acute coronary syndrome. They were divided into three groups: two experimental groups and one control group. One of the experimental groups used the bicycle ergometer as its main physical activity, whereas the other received training in a modified form of tennis lesson. By the end of the 3-month program, triglycerides, cholesterol LDL, cholesterol HDL, (-25 mg∙dl-1 and 32.3 mg∙dl-1 final, and 15.7 mg∙dl-1 and 23.3 mg∙dl-1 LDL final, respectively) and exercise capacity improved significantly (by 1.1 metabolic equivalents (METs) and 1.2 METs, respectively), in both experimental groups. We conclude that the application of a comprehensive cardiac rehabilitation program in patients with low-risk acute coronary syndrome based on a program of modified tennis improves exercise tolerance and metabolic parameters, as well as certain physical characteristics that reduce cardiovascular risk. [ABSTRACT FROM AUTHOR]

Objective: XXXto assess the effect on cognition of a controlled intervention testing Mediterranean diets (MedDiet). Design: XXXrandomized trial after 6.5 years of nutritional intervention. Setting: Eight primary care centers affiliated to the University of Navarra. Participants: A random subsample of 285 participants (95 randomly allocated to each of 3 groups) of the PREDIMED-NAVARRA trial. All of them were at high vascular risk (44.8% men, 74.1± 5.7 years at cognitive evaluation). Interventions: Nutritional intervention comparing two MedDiets (supplemented with extra-virgin olive oil [EVOO] or mixed nuts) versus a low-fat control diet. Participants received intensive education to increase adherence to the intended intervention. Participants allocated to the MedDiet groups received EVOO (1 l/week) or 30 g/day of mixed nuts. Dietary habits were evaluated using a validated 137-item food frequency questionnaire (FFQ). Additionally, adherence to MedDiet was appraised using a 14-item questionnaire both at baseline and yearly thereafter. Measurements: XXXcognitive performance as a main outcome and cognitive status (normal, mild cognitive impairment [MCI] or dementia) as a secondary outcome were evaluated by two neurologists blinded to group assignment after 6.5 years of nutritional intervention. Results: Better post-trial cognitive performance versus control in all cognitive domains and significantly better performance across fluency and memory tasks were observed for participants allocated to the MedDiet+EVOO group. After adjustment for sex, age, education, apolipoprotein E genotype, family history of cognitive impairment/dementia, smoking, physical activity, body mass index, hypertension, dyslipidaemia, diabetes, alcohol and total energy intake, this group also showed lower MCI (OR=0.34 95% CI: 0.12-0.97) compared with control group. Participants assigned to MedDiet+Nuts group did not differ from controls. Conclusion: A long-term intervention with an EVOO-rich MedDiet resulted in a better cognitive function in comparison with a control diet. However, non-significant differences were found for most cognitive domains. Participants allocated to an EVOO-rich MedDiet had less MCI than controls. [ABSTRACT FROM AUTHOR]

Background: Smoking is the main preventable cause of morbidity and mortality in our region, it being the main causative agent of chronic obstructive pulmonary disease. There still is no consensus on the use of spirometry as a strategy for smoking cessation, given that there is insufficient scientific evidence from high quality studies to recommend the use of this technique. Methods/design: This is to be a randomized, multicentre, open-label clinical trial. A total of 444 smokers over 40 years of age will be recruited by 39 general practitioners from 22 health centers.Primary objective of this study is to assess the effectiveness of spirometry together with information regarding the test for smoking cessation after 1 year in smokers over 40 years of age with a more than 10 pack-year history and no previous diagnosis of chronic obstructive pulmonary disease.Groups of 45 patients who smoke will be randomly selected from the lists of the participating doctors. The names will be sent to the corresponding doctors who will contact candidate patients and assess whether they meet the selection criteria. Patients who meet these criteria will be randomly allocated to an intervention or control group.For patients in both groups, a nurse will conduct an interview and perform a spirometry test to measure forced vital capacity. Then, all patients will be referred for an appointment with their doctor for brief anti-smoking intervention, patients from the intervention group additionally being informed about the result of the spirometry test.After 1 year, smoking status will be assessed and, in those who report that they have quit smoking, abstinence will be confirmed by cooximetry. Data will be analyzed on an intention-to-treat basis using the chi-squared test for outcomes and binary logistic regression if it is considered to be necessary to adjust for confounding variables. Discussion: Performing a spirometry test and providing information on pulmonary function may increase awareness of the effect of smoking among smokers who are asymptomatic or have few symptoms and make them decide to quit. Specifically, in patients with chronic obstructive pulmonary disease it might increase levels of motivation to quit smoking in early stages of the disease. If this strategy were to be effective, it could be included in the health promotion activities offered in primary care. Trial registration: ClinicalTrials.gov Identifier: NCT01821885. [ABSTRACT FROM AUTHOR]

Objective: To assess the effectiveness of health and nutrition program (NutriAlz) versus usual care on functional level in elderly people with dementia living at home, as well as on clinical practice related to nutrition and on the caregiver's burden. Design: Cluster randomized multi-centre study with one-year follow-up. Setting: 11 Alzheimer outpatients and day care centres (Barcelona, Spain). Participants: Nine hundred and forty six home-living Alzheimer patients with identified caregiver were consecutively recruited (intervention group: 6 centres, 448 patients vs control group: 5 centres, 498 patients). Intervention: The intervention was a teaching and training intervention on health and nutrition program, NutriAlz, directed both to physician and main caregiver, as well as persons affected by Alzheimer's disease or other dementias, including a standardised protocol for feeding and nutrition. Main Outcome Measures: The main outcome measure was the reduction in the loss of autonomy (Activities of daily living (ADL/IADL) scales) assessed at 6 and 12 months. Secondary outcomes measures were Improvement in nutritional status (Mini Nutritional Assessment (MNA), BMI, and weight changes), and caregiver burden (Zarit scale). Results: The one-year assessment was completed for 293 patients (65.4%) in the intervention group and 363 patients (72.9%) in the control group (usual care). The annual rate of ADL change was −0.83 vs −0.62 (p=0.984), and the caregiver's subjective burden 0.59 vs 2.36 (p=0.681) in intervention and control group, respectively. MNA, however, showed an improvement (+0.46 vs −0.66, p=0.028), suggesting an effective nutritional behaviour. Conclusion: The NutriAlz program had no effect on functional decline in Alzheimer disease patients living at home over one year, but reduced the risk for malnutrition, as recommendations concerning diet and exercise were provided. [ABSTRACT FROM AUTHOR]