Correction to: Efficiency as a determinant of loyalty among users of a Community of Clinical Practice: a comparative study between the implementation and consolidation phases.

Following publication of the original article [1], in order to comply with the current regulations for the submission of Doctoral Thesis by compendium of articles, the Universitat Autónoma de Barcelona Doctoral School asks us to update the affiliation number 3, adding "Departament de Medicina" at the beginning, as follows.

Efficiency as a determinant of loyalty among users of a Community of Clinical Practice: a comparative study between the implementation and consolidation phases.

BACKGROUND: A community of clinical practice called the Online Communication Tool between Primary and Hospital Care (ECOPIH) was created to enable primary care and specialist care professionals to communicate with each other in order to resolve real clinical cases, thereby improving communication and coordination between care levels. The present work seeks to analyse whether ECOPIH makes it possible to reduce the number of referrals. To that end, the objectives are: (1) To find out the degree of loyalty among ECOPIH users, by comparing the medical professionals' profiles in the tool's implementation phase to those in its consolidation phase. (2) To evaluate the degree of fulfilment of users' expectations, by establishing the determining factors that had an influence on the physicians' intention to use ECOPIH in the implementation phase and observing whether its use had an effective, direct impact on the number of patient referrals that primary care physicians made to specialist care professionals. METHODS: Two studies were conducted. Based on a survey of all the physicians in a Primary Care area, Study 1 was a descriptive study in ECOPIH's implementation phase. Study 2 was a randomised intervention study of ECOPIH users in the tool's consolidation phase. The results from both studies were compared. Various bivariate and multivariate statistical techniques (exploratory factor analysis, cluster analysis, logistic regression analysis and ANOVA) were used in both studies, which were conducted on a sample of 111 and 178 physicians, respectively. RESULTS: We confirmed the existence of an ECOPIH user profile stable across both phases: under-50-year-old women. Regarding the second objective, there were two particular findings. First, the discriminant factors that had an influence on greater ECOPIH use were habitual Social media website and app use and Perceived usefulness for reducing costs. Second, PC professionals who were ECOPIH members made fewer referrals to SC professionals in Cardiology, Endocrinology and Gastroenterology than older PC professionals who were not ECOPIH members. CONCLUSIONS: The use of a community of clinical practice by primary care and specialist care professionals helps to reduce the number of referrals among medical professionals.

Effectiveness of a multidisciplinary BIOPSYCHOSOCIAL intervention for non-specific SUBACUTE low back pain in a working population: a cluster randomized clinical trial.

BACKGROUND: Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Current guidelines for the treatment of LBP recommend pharmacological and non-pharmacological strategies. The aim of this study was to compare usual clinical practice with the effectiveness of a biopsychosocial multidisciplinary intervention in reducing disability, severity of pain and improving quality of life in a working population of patients with subacute (2-12 weeks), non-specific LBP. METHODS: Longitudinal cluster randomized clinical trial conducted in 39 Primary Health Care Centres (PHCC) of Barcelona, with patients aged 18-65 years (n = 501; control group = 239; 26 PHCC, intervention group = 262; 13 PHCC). The control group received usual clinical care. The intervention group received usual clinical care plus a biopsychosocial multidisciplinary intervention, which consisted of physiotherapy, cognitive-behavioural therapy and medication. The main outcomes were changes in the Roland Morris Disability Questionnaire (RMDQ), and the minimal clinically important differences. Secondary outcomes were changes in the McGill Pain (MGPQ) and Quality of Life (SF-12) questionnaires. Assessment was conducted at baseline, 3 and 12 months. Analysis was by intention-to-treat and analyst-blinded. Multiple imputations were used. RESULTS: Of the 501 enrolled patients, 421 (84%) provided data at 3 months, and 387 (77.2%) at 12 months. Mean age was 46.8 years (SD: 11.5) and 64.7% were women. In the adjusted analysis of the RMDQ outcome, only the intervention group showed significant changes at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups. In the adjusted analysis of the RMDQ outcome, the intervention group improvement more than the control group at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027). The intervention group presented a significant difference. Both groups presented a minimal clinically important difference, but more difference in the intervention group. The intervention group presented significant differences in the MGPQ scales of current pain intensity and VAS scores at 3 months. No statistically significant differences were found in the physical and mental domains of the SF-12. CONCLUSIONS: A multidisciplinary biopsychosocial intervention in a working population with non-specific subacute LBP has a small positive impact on disability, and on the level of pain, mainly at short-term, but no difference on quality of life. TRIAL REGISTRATION: ISRCTN21392091 (17 oct 2018) (Prospectively registred).

Effect of comprehensive smoke-free legislation on asthma and coronary disease trends in Spanish primary care patients.

Background: To examine the impact of comprehensive smoke-free legislation (SFL) (Law 42/2010) on the incidence and prevalence of adult asthma and coronary disease in primary health care (PHC) patients from three Spanish regions, overall and stratified by sex. Methods: Longitudinal observational study conducted between 2007 and 2013 in the population over 15 years of age assigned to 66 PHC teams in Catalonia, Navarre and the Balearic Islands. Crude rates and age-standardized (truncated: asthma ≥ 16 years and coronary disease ≥ 35 years) incidence and prevalence rates using the direct method based on the European Standard Population were estimated based on data from PHC electronic health records. Joinpoint analysis was used to analyse the trends of age-standardized incidence and prevalence rates. Trends were expressed as annual percentage change and average annual percent change (AAPC). Results: The standardized asthma incidence rate showed a non-significant downward trend and the standardized prevalence rates rose significantly in the three regions. Standardized coronary disease incidence and prevalence rates were considerably higher for men than for women in all regions. The standardized coronary disease incidence rates in Catalonia (AAPC: -8.00%, 95% CI: -10.46; -5.47) and Navarre (AAPC: -3.66%, 95% CI: -4.95;-2.35) showed a significant downward trend from 2007 to 2013, overall and by sex. The standardized coronary disease prevalence trend rate increased significantly in the whole period in Catalonia and the Balearic Islands, although a non-significant downward trend was observed from 2010 in Catalonia. Conclusion: No changes in the trends of adult asthma and coronary disease in PHC Spanish patients were detected after the introduction of comprehensive SFL.

[Multimorbidity patterns in young adults in Catalonia: an analysis of clusters]. / Patrones de multimorbilidad en adultos jóvenes en Cataluña: un análisis de clústeres.

OBJECTIVE: The aim of this study was to identify multimorbidity patterns in patients from 19 to 44 years attended in primary care in Catalonia in 2010. DESIGN: Cross-sectional study. SETTING: 251 primary care centres. PARTICIPANTS: 530,798 people with multimorbidity, aged 19 to 44 years. MAIN OUTCOME MEASURES: Multimorbidity was defined as the coexistence of ≥2 more International Classification system (ICD-10) registered in the electronic health record. Multimorbidity patterns were identified using hierarchical cluster analysis and by sex and age group (19-24 and 25-44). RESULTS: Of the 882,708 people from initial population, 530,798 (60.1%) accomplished multimorbidity criterion. Mean age was 33.0 years (SD: 7.0) and 53.3% were women. Multimorbidity was higher in the 25-to 44-years-old group with respect the younger group (60.5 vs. 58.1%, p<0.001), being higher in women. Most prevalent cluster in all groups included, among others, by dental caries, smoking, dorsalgia, common cold and other anxiety disorders. For both sexes in the 25-to 44-years-old group appeared the cardiovascular-endocrine-metabolic pattern (obesity, lipid disorders and arterial hypertension). CONCLUSIONS: Multimorbidity affects more than half of persons between 19 to 44-years-old. The most prevalent cluster is formed by grouping common diseases (dental caries, common cold, smoking, anxiety disorders and dorsalgias). Another pattern to highlight is the cardiovascular-endocrine-metabolic pattern in the 25- to 44 years-old group. Knowledge of patterns of multimorbidity in young adults could be used to design individualized preventive strategies.

Influence of chronic illnesses and underlying risk conditions on the incidence of pneumococcal pneumonia in older adults.

OBJECTIVE: To investigate hospitalizations from pneumococcal pneumonia in older adults with specific underlying chronic conditions, evaluating the influence of these conditions in developing pneumonia. METHODS: Population-based cohort study involving 27,204 individuals ≥ 60 years old in Southern Catalonia, Spain. All cases of hospitalization from pneumococcal pneumonia (bacteremic and nonbacteremic) were collected since 01/12/2008 until 30/11/2011. Cox regression was used to calculate hazards ratio (HR) and estimate the association between baseline conditions and the risk of developing pneumococcal pneumonia. RESULTS: Maximum incidences (per 1000 person-years) appeared among patients with history of prior pneumonia (14.6), nursing home residents (12.8), persons with immunodeficiency/asplenia (7.7) and patients with chronic pulmonary disease (7.6). In multivariable analysis, age (HR: 1.05), nursing home residence (HR: 4.59), history of prior pneumonia (HR: 3.58), stroke (HR: 2.50), chronic heart disease (HR: 1.53), chronic pulmonary disease (HR: 4.09), diabetes mellitus (HR: 1.66), smoking (HR: 1.69) and immunosuppressive medication (HR: 1.87) appeared significantly associated with an increased risk of pneumococcal pneumonia. CONCLUSION: Our data support that nursing home residence, chronic pulmonary disease and immunocompromising conditions are the underlying conditions most strongly associated with an increasing risk of pneumococcal pneumonia in older adults. This data underline the need for better prevention strategies among these persons.

Variability in screening prevention activities in primary care in Spain: a multilevel analysis.

BACKGROUND: Despite evidence of the benefits of prevention activities, studies have reported only partial integration and great variability of screening in daily clinical practice. The study objectives were: 1) To describe Primary Health Care (PHC) screening for arterial hypertension, dyslipidaemia, obesity, tobacco use, and excessive alcohol consumption in 2008 in 2 regions of Spain, based on electronic health records, and 2) To assess and quantify variability in screening, and identify factors (of patient, general practitioners and PHC team) associated with being screened, that are common throughout the PHC population. METHODS: Multicentre, cross-sectional study of individuals aged ≥ 16 years (N = 468,940) who visited the 426 general practitioners (GPs) in 44 PHC teams in Catalonia and Navarre in 2008. OUTCOMES: screening for hypertension, dyslipidaemia, obesity, tobacco use, and excessive alcohol consumption. Other variables were considered at the individual (sociodemographics, visits, health problems), GP and PHC team (region among others). Individual and contextual factors associated with the odds of being screened and the variance attributable to each level were identified using the SAS PROC GLIMMIX macro. RESULTS: The most prevalent screenings were for dyslipidaemia (64.4%) and hypertension (50.8%); the least prevalent was tobacco use (36.6%). Overall, the odds of being screened were higher for women, older patients, those with more comorbidities, more cardiovascular risk factors, and more frequent office visits, and those assigned to a female GP, a GP with a lower patient load, or a PHC team with a lower percentage of patients older than 65 years. On average, individuals in Navarre were less likely to be screened than those in Catalonia. Hypertension and dyslipidaemia screenings had the least unexplained variability between PHC teams and GPs, respectively, after adjusting for individual and contextual factors. CONCLUSIONS: Of the studied screenings, those for obesity, tobacco, and alcohol use were the least prevalent. Attention to screening, especially for tobacco and alcohol, can be greatly improved in the PHC setting.

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

BACKGROUND: The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis. METHODS/DESIGN: Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. PARTICIPANTS: 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. CONTROL GROUP: will receive standard care. MAIN OUTCOME VARIABLE: quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1. DISCUSSION: If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care. TRIAL REGISTRATION: ISRCTN57405925. Registred 20 June 2014.

Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against community-acquired pneumonia in the general population aged ≥ 60 years: 3 years of follow-up in the CAPAMIS study.

BACKGROUND: The benefits of using the 23-valent pneumococcal polysaccharide vaccine (PPV23) are controversial. This study assessed clinical effectiveness of PPV23 in preventing community-acquired pneumonia (CAP) among the general population aged ≥ 60 years. METHODS: This was a population-based cohort study involving 27 204 individuals aged ≥ 60 years in Tarragona, Spain, who were prospectively followed from 1 December 2008 until 30 November 2011. Primary outcomes were hospitalization for pneumococcal CAP (bacteremic and nonbacteremic cases) and all-cause CAP. All CAP cases were radiographically confirmed and validated by checking clinical records. Cox regression was used to evaluate the association between pneumococcal vaccination and the risk of each outcome. RESULTS: Cohort members were followed for a total of 76 033 person-years (29 065 person-years for vaccinated subjects). Incidence rates (per 1000 person-years) were 0.21 for bacteremic pneumococcal CAP (0.14 vs 0.26 among vaccinated and unvaccinated subjects, respectively), 1.45 for nonbacteremic pneumococcal CAP (1.46 vs 1.44), and 7.51 for all-cause CAP (7.19 vs 7.71). In primary analyses including all cohort members, PPV23 did not appear to be effective against any analyzed outcome. However, a beneficial effect emerged in sensitive and stratified analyses. After multivariable adjustments, as compared with those never vaccinated, recent vaccination with PPV23 (<5 years ago) was associated with reduced risks of bacteremic pneumococcal CAP (hazard ratio [HR], 0.38; 95% confidence interval [CI], .09-1.68), nonbacteremic pneumococcal CAP (HR, 0.52; 95% CI, .29-.92), overall pneumococcal CAP (HR, 0.49; 95% CI, .29-.84), and all-cause CAP (HR, 0.75; 95% CI, .58-.98). CONCLUSIONS: Our data support a protective effect of recent PPV23 vaccination (within previous 5 years) against both pneumococcal and all-cause CAP.

Burden of multimorbidity, socioeconomic status and use of health services across stages of life in urban areas: a cross-sectional study.

BACKGROUND: The burden of chronic conditions and multimorbidity is a growing health problem in developed countries. The study aimed to determine the estimated prevalence and patterns of multimorbidity in urban areas of Catalonia, stratified by sex and adult age groups, and to assess whether socioeconomic status and use of primary health care services were associated with multimorbidity. METHODS: A cross-sectional study was conducted in Catalonia. Participants were adults (19+ years) living in urban areas, assigned to 251 primary care teams. MAIN OUTCOME: multimorbidity (≥2 chronic conditions). Other variables: sex (male/female), age (19-24; 25-44; 45-64; 65-79; 80+ years), socioeconomic status (quintiles), number of health care visits during the study. RESULTS: We included 1,356,761 patients; mean age, 47.4 years (SD: 17.8), 51.0% women. Multimorbidity was present in 47.6% (95% CI 47.5-47.7) of the sample, increasing with age in both sexes but significantly higher in women (53.3%) than in men (41.7%). Prevalence of multimorbidity in each quintile of the deprivation index was higher in women than in men (except oldest group). In women, multimorbidity prevalence increased with quintile of the deprivation index. Overall, the median (interquartile range) number of primary care visits was 8 (4-14) in multimorbidity vs 1 (0-4) in non-multimorbidity patients. The most prevalent multimorbidity pattern beyond 45 years of age was uncomplicated hypertension and lipid disorder. Compared with the least deprived group, women in other quintiles of the deprivation index were more likely to have multimorbidity than men until 65 years of age. The odds of multimorbidity increased with number of visits in all strata. CONCLUSIONS: When all chronic conditions were included in the analysis, almost 50% of the adult urban population had multimorbidity. The prevalence of multimorbidity differed by sex, age group and socioeconomic status. Multimorbidity patterns varied by life-stage and sex; however, circulatory-endocrine-metabolic patterns were the most prevalent multimorbidity pattern after 45 years of age. Women younger than 80 years had greater prevalence of multimorbidity than men, and women's multimorbidity prevalence increased as socioeconomic status declined in all age groups. Identifying multimorbidity patterns associated with specific age-related life-stages allows health systems to prioritize and to adapt clinical management efforts by age group.

Impact of multimorbidity: acute morbidity, area of residency and use of health services across the life span in a region of south Europe.

BACKGROUND: Concurrent diseases, multiple pathologies and multimorbidity patterns are topics of increased interest as the world's population ages. To explore the impact of multimorbidity on affected patients and the consequences for health services, we designed a study to describe multimorbidity by sex and life-stage in a large population sample and to assess the association with acute morbidity, area of residency and use of health services. METHODS: A cross-sectional study was conducted in Catalonia (Spain). Participants were 1,749,710 patients aged 19+ years (251 primary care teams). PRIMARY OUTCOME: Multimorbidity (≥2 chronic diseases). Secondary outcome: Number of new events of each acute disease. Other variables: number of acute diseases per patient, sex, age group (19-24, 25-44, 45-64, 65-79, and 80+ years), urban/rural residence, and number of visits during 2010. RESULTS: Multimorbidity was present in 46.8% (95% CI, 46.7%-46.8%) of the sample, and increased as age increased, being higher in women and in rural areas. The most prevalent pair of chronic diseases was hypertension and lipid disorders in patients older than 45 years. Infections (mainly upper respiratory infection) were the most common acute diagnoses. In women, the highest significant RR of multimorbidity vs. non-multimorbidity was found for teeth/gum disease (aged 19-24) and acute upper respiratory infection. In men, this RR was only positive and significant for teeth/gum disease (aged 65-79). The adjusted analysis showed a strongly positive association with multimorbidity for the oldest women (80+ years) with acute diseases and women aged 65-79 with 3 or more acute diseases, compared to patients with no acute diseases (OR ranged from 1.16 to 1.99, p < 0.001). Living in a rural area was significantly associated with lower probability of having multimorbidity. The odds of multimorbidity increased sharply as the number of visits increased, reaching the highest probability in those aged 65-79 years. CONCLUSIONS: Multimorbidity is related to greater use of health care services and higher incidence of acute diseases, increasing the burden on primary care services. The differences related to sex and life-stage observed for multimorbidity and acute diseases suggest that further research on multimorbidity should be stratified according to these factors.

Evaluating clinical effectiveness of pneumococcal vaccination in preventing stroke: the CAPAMIS Study, 3-year follow-up.

BACKGROUND: Cerebrovascular benefits using the 23-valent pneumococcal polysaccharide vaccine (PPV23) are controversial. This study assessed clinical effectiveness of PPV23 in preventing ischemic stroke in people older than 60 years. METHODS: We conducted a population-based cohort study involving 27,204 individuals of 60 years or older in Tarragona, Spain, who were prospectively followed from December 01, 2008, until November 30, 2011. Outcomes were neuroimaging-confirmed ischemic stroke, 30-day mortality from stroke, and all-cause death. Pneumococcal vaccination effectiveness was evaluated by Cox regression analyses, estimating hazard ratios (HRs) adjusted for age, sex, comorbidities, and influenza vaccine status. RESULTS: Cohort members were followed for a total of 76,033 person-years, of which 29,065 were for vaccinated subjects. Overall, 343 cases of stroke, 45 deaths from stroke, and 2465 all-cause deaths were observed. Pneumococcal vaccination did not alter the risk of stroke (multivariable HR: 1.04; 95% confidence interval [CI]: .83-1.30; P=.752), death from stroke (HR: 1.14; 95% CI: .61-2.13; P=.686), and all-cause death (HR: .97; 95% CI: .89-1.05; P=.448). In analyses focused on people with and without a history of cerebrovascular disease, the PPV23 did not emerge effective in preventing any analyzed event, but influenza vaccine emerged independently associated with a reduced risk of death from stroke (HR: .51; 95% CI: .28-.93; P=.029) and all-cause death (HR: .73; 95% CI: .67-.81; P<.001). CONCLUSIONS: Our data support that the PPV23 does not provide benefit against ischemic stroke, but it also supports a beneficial effect of influenza vaccine in reducing specific- and all-cause mortality risk in the general population older than 60 years.

Effect of health professional education on outcomes of chronic obstructive pulmonary disease in primary care: a non-randomized clinical trial.

BACKGROUND AND OBJECTIVE: The best strategy to achieve optimal integrated management to patients with chronic obstructive pulmonary disease (COPD) in primary care (PC) is not clear. We aimed to evaluate the effectiveness of an intervention in PC based on an integrated programme, which combines diverse strategies directed at health professionals to improve quality of life and clinical outcomes of their patients with COPD. We compared the outcome with results from standard practice. METHODS: A prospective, multicentre, quasi-experimental study and a 12-month follow up was performed. Intervention consisted of an integrated education programme in PC. The main outcome variable was the change in total score of the St. George's Respiratory Questionnaire (SGRQ) at the end of follow up between the control and intervention group. RESULTS: A total of 801 patients participated in the study with a mean age of 70.2 years and a mean FEV1 (% predicted) of 55%. At 1-year follow up, the SGRQ score did not significantly differ. Although the intervention group showed an improvement in dietary, exercise and smoking habits, there was an increase in reported exacerbations and hospital admissions (P < 0.001). CONCLUSIONS: Implementation of an integrated education programme in a PC setting, which combines diverse strategies directed at health professionals, did not achieve the expected changes in quality of life measured by SGRQ at 1-year follow up. Nonetheless, this study observed an improvement in patients' lifestyle choices, even though this did not result in a significant change in the clinical evolution or heath status over 12 months.

[Ability of the modified CRB75 severity scale in assessing elderly patients with community acquired pneumonia]. / Utilidad de la escala de severidad modificada CRB75 en el manejo del paciente anciano con neumonía adquirida en la comunidad.

OBJECTIVE: To compare the ability of the classic CRB65 (confusion, respiratory rate, blood pressure and age ≥65 years) vs the modified CRB-75 for the severity assessment of patients 65 years or older with community acquired pneumonia (CAP). DESIGN: Prospective cohort study. SETTING: Tarragona Health Region. PARTICIPANTS: A total of 350 patients ≥65 years with a radiographically confirmed CAP (hospitalized or outpatient) during 2008-2010. MAIN OUTCOME MEASURES: The CRB-65 score (confusion; respiratory rate ≥30; systolic blood pressure <90 mmHg or diastolic ≤ 60 mmHg; age ≥65 years) and the modified CRB-75 (similar criteria but age ≥75 years) were calculated at the time of diagnosis, and 30-day mortality was considered as the main dependent variable. RESULTS: The overall 30-day mortality rate was 13.1% (4% in outpatient CAP and 15% in hospitalized CAP). According to CRB-65, mortality was 7,7% with a score of 1, 22.5% with a score of 2, and 50% with a score of 3 (no cases with a score of 4). Mortality also directly increased according to CRB-75, being 3,2% with a score of 0, 9,7% with a score of 1, 30.0% with a score of 2, and 45.5% with a score of 3. The discriminative value of both CRB65 and CRB75 rules to classify risk of short-term mortality among our study population was acceptable, with a better area under receive operating characteristic curve (ROC) for CRB75 than for CRB-65 (0,735 vs 0,681; P<.01). CONCLUSION: Both CRB-65 and CRB-75 scales are an acceptable tool to classify mortality risk among elderly patients with CAP. However, CRB-75 can be more useful for evaluating patients over 65 years with CAP.

Clinical effectiveness of pneumococcal vaccination against acute myocardial infarction and stroke in people over 60 years: the CAPAMIS study, one-year follow-up.

BACKGROUND: Conflicting results have been recently reported evaluating the relationship between pneumococcal vaccination and the risk of thrombotic vascular events. This study assessed the clinical effectiveness of the 23-valent polysaccharide pneumococcal vaccine (PPV23) against acute myocardial infarction and ischaemic stroke in older adults. METHODS: Population-based prospective cohort study conducted from December 1, 2008 until November 30, 2009, including all individuals ≥ 60 years-old assigned to nine Primary Care Centres in Tarragona, Spain (N = 27,204 individuals). Primary outcomes were hospitalisation for acute myocardial infarction and/or ischaemic stroke. All cases were validated by checking clinical records. The association between pneumococcal vaccination and the risk of each outcome was evaluated by Multivariable Cox proportional-hazard models (adjusted by age, sex, influenza vaccine status, presence of comorbidities and cardiovascular risk factors). RESULTS: Cohort members were followed for a total of 26,444 person-years, of which 34% were for vaccinated subjects. Overall incidence rates (per 1000 person-years) were 4.9 for myocardial infarction and 4.6 for ischaemic stroke. In the multivariable analysis, vaccination was associated with a marginally significant 35% lower risk of stroke (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.42-0.99; p = 0.046). We found no evidence for an association between pneumococcal vaccination and reduced risk of myocardial infarction (HR: 0.83; 95% CI: 0.56-1.22; p = 0.347). CONCLUSIONS: Our data supports a benefit of PPV23 against ischaemic stroke among the general population over 60 years, suggesting a possible protective role of pneumococcal vaccination against some acute thrombotic events.

Variability and concordance of Cornell and Sokolow-Lyon electrocardiographic criteria in hypertensive patients.

AIM: To assess the variability and concordance of left ventricular hypertrophy electrocardiographic (LVH-ECG) criteria. METHODS AND RESULTS: Convenience sampling of hypertensive subjects without coronary disease or bundle branch blocks. Two electrocardiograms (ECGs) were performed on each patient. Two investigators carried out two blind-readings of each ECG (Cornell and Sokolow-Lyon criteria). The between-rater and within-rater reliability were assessed (intraclass correlation coefficient, ICC). Poor concordance was defined: mean voltage difference between both ECGs >2 mm; 824 ECG readings were performed in 103 subjects (58.3% females), aged 66.8±8.8 years, mean blood pressure 141±15.10/78±9.0 mmHg. The between-rater ICCs of the baseline ECG were 0.97(95% CI 0.96-0.98) and 0.98 (95% CI 0.97-0.99) for Cornell and Sokolow-Lyon criteria, respectively. Poor concordance was found in 39.8% and in 41.7% of the cases for Cornell and Sokolow-Lyon criteria, respectively. Systolic blood pressure was found to be significant and positively associated with both criteria. Elderly hypertensive subjects, with higher ECG voltages and lower pulse pressure presented poor concordance of Cornell criteria. CONCLUSIONS: The between-rater and within-rater reliability of Cornell and Sokolow-Lyon criteria is minimal. Approximately 40% of hypertensive subjects presented poor concordance in a second ECG. Older patients with lower pulse pressure and higher baseline voltages presented poorer reproducibility of LVH-ECG criteria.

The role of gender in a smoking cessation intervention: a cluster randomized clinical trial.

BACKGROUND: The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. METHODS: This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. RESULTS: At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). CONCLUSIONS: Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. CLINICALTRIALS.GOV IDENTIFIER: NCT00125905.

Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.

BACKGROUND: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. METHODS/DESIGN: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term).Assessment of outcomes will be blinded and will follow the intention-to-treat principle. DISCUSSION: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN: ISRCTN58719694.

Effectiveness of the 23-valent polysaccharide pneumococcal vaccine against invasive pneumococcal disease in people 60 years or older.

BACKGROUND: The 23-valent polysaccharide pneumococcal vaccine (PPV) is currently recommended in elderly and high-risk adults. However, its efficacy in preventing pneumococcal infections remains controversial. This study assessed the clinical effectiveness of vaccination against invasive pneumococcal disease (IPD) among people over 60 years. METHODS: Population-based case-control study that included 88 case patients over 60 years-old with a laboratory-confirmed IPD (bacteraemic pneumonia, meningitis or sepsis) and 176 outpatient control subjects who were matched by primary care centre, age, sex and risk stratum. Adjusted odds ratios (ORs) for vaccination were calculated using conditional logistic regression, controlling for underlying conditions. Vaccine effectiveness was estimated as (1 - OR) x100. RESULTS: Pneumococcal vaccination rate was significantly lower in cases than in control subjects (38.6% vs 59.1%; p = 0.002). The adjusted vaccine effectiveness was 72% (OR: 0.28; 95% CI: 0.15-0.54) against all IPD and 77% (OR: 0.23; 95% CI: 0.08-0.60) against vaccine-type IPD. Vaccination was significantly effective against all IPD in both age groups: 60-79 years-old (OR 0.32; 95% CI: 0.14-0.74) and people 80 years or older (OR: 0.29; 95% CI: 0.09-0.91). Vaccination appears significantly effective as for high-risk immunocompetent subjects (OR: 0.29; 95% CI: 0.11-0.79) as well as for immunocompromised subjects (OR: 0.12; 95% CI: 0.03-0.53). CONCLUSION: These findings confirm the effectiveness of the 23-valent PPV against IPD, and they also support the benefit of vaccination in preventing invasive infections among high-risk and older people.

Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.

BACKGROUND: Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. METHODS/DESIGN: A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. DISCUSSION: We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain, and to reduce the duration of non-specific low back pain episodes. If the intervention is effective, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN21392091.