Effectiveness of an educational intervention to improve the safety culture in primary care: a randomized trial.

BACKGROUND: Fostering a culture of safety is an essential step in ensuring patient safety and quality in primary care. We aimed to evaluate the effectiveness of an educational intervention to improve the safety culture in the family and community medicine teaching units in an Atlantic European Region. METHODS: Randomized study conducted in family and community medicine teaching units in Galicia (Spain). Participants were all fourth-year residents and their tutors (N = 138). Those who agreed to participate were randomized into one of two groups (27 tutors/26 residents in the intervention group, 23 tutors/ 23 residents in the control one).All were sent the Survey on Patient Safety Culture. After that, the intervention group received specific training in safety; they also recorded incidents over 15 days, documented them following a structured approach, and had feedback on their performance. The control group did not receive any action. All participants completed the same survey four months later. Outcome measures were the changes in safety culture as quantified by the results variables of the Survey: Patient Safety Grade and Number of events reported. We conducted bivariate and adjusted analyses for the outcome measures. To explore the influence of participants' demographic characteristics and their evaluation of the 12 dimensions of the safety culture, we fitted a multivariate model for each outcome. RESULTS: Trial followed published protocol. There were 19 drop outs. The groups were comparable in outcome and independent variables at start. The experiment did not have any effect on Patient safety grade (- 0.040) in bivariate analysis. The odds of reporting one to two events increased by 1.14 (0.39-3.35), and by 13.75 (2.41-354.37) the odds of reporting 3 or more events. Different dimensions had significant independent effects on each outcome variable. CONCLUSION: A educational intervention in family and community medicine teaching units may improve the incidents reported. The associations observed among organizational dimensions and outcomes evidence the complexity of patient safety culture measurement and, also, show the paths for improvement. In the future, it would be worthwhile to replicate this study in teaching units from different settings and with different health professionals engaged. TRIAL REGISTRATION: It was retrospectively registered with ( ISRCTN41911128 , 31/12/2010).

Nomogram and Validity of a Model for Predicting Malnutrition in Patients on Liver Transplant Lists.

BACKGROUND: Malnutrition is associated with increased morbimortality in liver transplant patients, and it is important to identify factors related to nutritional status in these patients. AIMS: Determine variables associated with malnutrition and create a nomogram in liver transplant candidates. METHODS: Cross-sectional study (n = 110). VARIABLES: demographic variables, imbalances due to the disease, transplant aetiology and analytical parameters. Physical examination was performed and degree of hepatic dysfunction calculated. Nutritional status was assessed: Controlling Nutritional Status, Spanish Society of Parenteral and Enteral Nutrition criteria, Nutritional Risk Index, Prognostic Nutritional Index or Onodera Index and The Subjective Global Assessment. Logistic regression analysis was performed. A predictive nomogram (discrimination and calibration analysis) was generated. RESULTS: Malnourishment was defined according to at least 4 or more of the methods studied. Patients with ascites, encephalopathy and portal hypertension presented malnourishment more frequently. Malnutrition was associated with greater liver dysfunction and lower grip strength. Variables independently associated with malnourishment were encephalopathy and lower albumin values. A nomogram was created to predict malnourishment, with good discriminatory power and calibration. CONCLUSIONS: A score was developed for evaluating malnutrition risk. This would provide a tool that makes it possible to quickly and easily identify the risk of malnutrition in liver transplant candidates.

Predictive factors of satisfaction and quality of life after immediate breast reconstruction using the BREAST-Q©.

AIMS AND OBJECTIVES: To analyse quality of life and satisfaction after immediate breast reconstruction due to cancer and its determining factors. BACKGROUND: Studying breast reconstruction is important because of its frequency and variability. In addition to the surgical results, it is necessary to analyse the quality of life and patient satisfaction using a specific tool. DESIGN METHODS: An ambispective design was used (n = 101; α = 0.05; precision = 10%), studying anthropometric, sociocultural data, Fagerström test and the BREAST-Q© questionnaire. A logistic regression analysis was performed to identify variables associated with quality of life and satisfaction. RESULTS: Mean age of the patients on diagnosis was 44.87 ± 8.5 years. Forty-one of the patients were carried out a skin-sparing mastectomy (42.7%). Immediate reconstruction was performed with implant in 73 (74.5%). The domains on the BREAST-Q© for quality of life with the lowest scores were physical well-being chest (74) and sexual well-being (61.5). The satisfaction domain with the lowest score was with the breast (59). The variables associated with the worst quality of life in the physical well-being chest domain were the skin-sparing mastectomy (OR, 4.2; 95% confidence interval (CI), 1.2-14.1) and lymphedema (OR, 12.9; 95% CI, 1.0-159.9). Antibody treatment was associated with a worse score on the psychosocial well-being domain (OR, 4.25; 95% CI, 1.0-18.0) and sexual well-being domain (OR, 7.34; 95% CI, 0.9-54.6). Satisfaction was associated with nicotine dependence on the breast and outcome scale. The higher the dependence on nicotine, the greater the dissatisfaction with the breasts (OR, 2.41; 95% CI, 1.1-5.3) and with the result (OR, 2.45; 95% CI, 1.0-5.9). CONCLUSIONS: The type of treatment and lymphedema modify the patients' quality of life. Nicotine dependence is associated with lower satisfaction with the breast and with the outcome. RELEVANCE TO CLINICAL PRACTICE: This study suggests the need for multidisciplinary attention during the first year of adjuvant treatment despite the benefits of immediate reconstruction. It shows the need for preoperative assessment of the level of nicotine dependence, anxiety and depression of smoking patients before preoperative counselling.

Incidence of cardiovascular events and associated risk factors in kidney transplant patients: a competing risks survival analysis.

BACKGROUND: The high prevalence of cardiovascular risk factors among the renal transplant population accounts for increased mortality. The aim of this study is to determine the incidence of cardiovascular events and factors associated with cardiovascular events in these patients. METHODS: An observational ambispective follow-up study of renal transplant recipients (n = 2029) in the health district of A Coruña (Spain) during the period 1981-2011 was completed. Competing risk survival analysis methods were applied to estimate the cumulative incidence of developing cardiovascular events over time and to identify which characteristics were associated with the risk of these events. Post-transplant cardiovascular events are defined as the presence of myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances, peripheral vascular disease and cardiovascular disease and death. The cause of death was identified through the medical history and death certificate using ICD9 (390-459, except: 427.5, 435, 446, 459.0). RESULTS: The mean age of patients at the time of transplantation was 47.0 ± 14.2 years; 62% were male. 16.5% had suffered some cardiovascular disease prior to transplantation and 9.7% had suffered a cardiovascular event. The mean follow-up period for the patients with cardiovascular event was 3.5 ± 4.3 years. Applying competing risk methodology, it was observed that the accumulated incidence of the event was 5.0% one year after transplantation, 8.1% after five years, and 11.9% after ten years. After applying multivariate models, the variables with an independent effect for predicting cardiovascular events are: male sex, age of recipient, previous cardiovascular disorders, pre-transplant smoking and post-transplant diabetes. CONCLUSIONS: This study makes it possible to determine in kidney transplant patients, taking into account competitive events, the incidence of post-transplant cardiovascular events and the risk factors of these events. Modifiable risk factors are identified, owing to which, changes in said factors would have a bearing of the incidence of events.

Concordance among methods of nutritional assessment in patients included on the waiting list for liver transplantation.

BACKGROUND: The aim of the present study was to determine the extent of malnutrition in patients waiting for a liver transplant. The agreement among the methods of nutritional assessment and their diagnostic validity were evaluated. METHODS: Patients on the waiting list for liver transplantation (n = 110) were studied. The variables were: body mass index, analytical parameters, liver disease etiology, and complications. Liver dysfunction was evaluated using the Child-Pugh Scale. Nutritional state was studied using the Controlling Nutritional Status (CONUT), the Spanish Society of Parenteral and Enteral Nutrition (SENPE) criteria, the Nutritional Risk Index (NRI), the Prognostic Nutritional Index (PNI-O), and the Subjective Global Assessment (SGA). Agreement was determined using the Kappa index. Area under receiver operator characteristic curves (AUCs), the Youden index (J), and likelihood ratios were computed. RESULTS: Malnutrition varied depending on the method of evaluation. The highest value was detected using the CONUT (90.9%) and the lowest using the SGA (50.9%). The pairwise agreement among the methods ranged from K = 0.041 to K = 0.826, with an overall agreement of each criteria with the remaining methods between K = 0.093 and K = 0.364. PNI-O was the method with the highest overall agreement. Taking this level of agreement into account, we chose the PNI-O as a benchmark method of comparison. The highest positive likelihood ratio for the diagnosis of malnutrition was obtained from the Nutritional Risk Index (13.56). CONCLUSIONS: Malnutrition prevalence is high and prevalence estimates vary according the method used, with low concordance among methods. PNI-O and NRI are the most consistent methods to identify malnutrition in these patients.

Hallux valgus in a random population in Spain and its impact on quality of life and functionality.

The aim of this study was to determine the prevalence of Hallux valgus (HV) and the association between the presence thereof and quality of life, dependence for basic and instrumental activities of daily living and foot function. Prevalence study was carried out in a random population sample (n = 1837) (α = 0.05; Precision = ±2.2%). Informed consent and ethical review board were obtained (code 2008/264). We studied anthropometric variables, Charlson Comorbidity Index, function and state of foot [Foot Function index (FFI), Foot Health Status Questionnaire (FHSQ)], quality of life (SF-36), and dependence for activities of daily living (Barthel and Lawton index). Degree of HV was determined using Manchester scale. Descriptive and multivariate logistic regression analyses were performed. Hence, the prevalence of HV is 39%. Patients with HV are significantly older (64.6 ± 11.7 vs 60.1 ± 12.6 years old). HV prevalence is greater in females (48.1 vs. 28.3%), subjects with flat foot (48.1 vs. 36.1%) or hammer toes (48.2 vs. 30.9%). Moreover, with regard to the presence or not of HV, statistically significant differences were neither noted in the SF-36 questionnaire nor in the Barthel and Lawton Index. For FHSQ and FFI questionnaires, significant differences were observed between patients who presented HV and those who did not. HV is associated with age, gender, flat foot and hammer toes. The SF-36 and Barthel and Lawton questionnaires remained unaltered by the presence of HV. The presence of Hallux valgus was associated with reduced quality of life and increases foot pain, disability and functional limitation.

Effect of diagnostic delay on survival in patients with colorectal cancer: a retrospective cohort study.

BACKGROUND: Disparate and contradictory results make studies necessary to investigate in more depth the relationship between diagnostic delay and survival in colorectal cancer (CRC) patients. The aim of this study is to analyse the relationship between the interval from first symptom to diagnosis (SDI) and survival in CRC. METHODS: Retrospective study of n = 942 CRC patients. SDI was calculated as the time from the diagnosis of cancer and the first symptoms of CRC. Cox regression was used to estimate five-year mortality hazard ratios as a function of SDI, adjusting for age and gender. SDI was modelled according to SDI quartiles and as a continuous variable using penalized splines. RESULTS: Median SDI was 3.4 months. SDI was not associated with stage at diagnosis (Stage I = 3.6 months, Stage II-III = 3.4, Stage IV = 3.2; p = 0.728). Shorter SDIs corresponded to patients with abdominal pain (2.8 months), and longer SDIs to patients with muchorrhage (5.2 months) and rectal tenesmus (4.4 months). Adjusting for age and gender, in rectum cancers, patients within the first SDI quartile had lower survival (p = 0.003), while in colon cancer no significant differences were found (p = 0.282). These results do not change after adjusting for TNM stage. The splines regression analysis revealed that, for rectum cancer, 5-year mortality progressively increases for SDIs lower than the median (3.7 months) and decreases as the delay increases until approximately 8 months. In colon cancer, no significant relationship was found between SDI and survival. CONCLUSIONS: Short diagnostic intervals are significantly associated with higher mortality in rectal but not in colon cancers, even though a borderline significant effect is also observed in colon cancer. Longer diagnostic intervals seemed not to be associated with poorer survival. Other factors than diagnostic delay should be taken into account to explain this "waiting-time paradox".

Assessment of nutritional status and health-related quality of life before and after liver transplantation.

BACKGROUND: Patients with chronic liver disease frequently suffer from malnutrition, together with a decline in their health-related quality of life. This study was carried out with the aim of evaluating the nutritional status, complications of medical and surgical care, anxiety, health-related quality of life and dependence level on basic and instrumental activities of daily living in pre- and post-liver transplant patients. METHODS/DESIGN: A prospective observational study with follow-up of patients on the waiting list for liver transplants who subsequently received a transplant at the University Hospital Complex in A Coruña during the period 2012-2014 (n = 110). All the patients will be followed-up for a maximum of 6 months. For survivors, assessments will be re-evaluated at one, three and six months post- transplant. Informed consent of the patient and ethical review board approval was obtained (Code: 2010/081 and 2010/082). The following variables will be studied: socio-demographic data, reason for the transplant, comorbidity (Charlson Score), analytical parameters, time on transplant waiting list and post-transplant complications. A trained nurse will evaluate the following for each patient: nutritional indices, anthropometric variables and handgrip strength. Validated questionnaires will be used to determine the patients' nutritional status (Subjective Global Assessment), anxiety (STAI questionnaire), Health-Related Quality of Life (LDQoL 1.0 questionnaire), dependence (Barthel Index and Lawton-Brody Scale), nursing diagnoses (NANDA) and post-transplant quality indicators. Multiple linear/logistic regression models will be used to identify variables associated with the events of interest. Changes in nutritional status, quality of life and dependence over time will be analysed with linear mixed-effects regression models. Actuarial survival analysis using Kaplan-Meier curves, Cox regression and competitive risk will be performed Concordance between the different scores that assess nutritional status and interobserver agreement regarding nursing diagnoses will be studied using the statistical Kappa index and Bland Altman method. DISCUSSION: The risk of malnutrition can be considered as a possible prognostic factor in transplant outcomes, associated with anxiety, health-related quality of life and dependence. For this reason we consider interesting to perform a prospective follow-up study of patients who require a transplant to survive, studying their nutritional status and health-related quality of life.

Validity of footprint analysis to determine flatfoot using clinical diagnosis as the gold standard in a random sample aged 40 years and older.

BACKGROUND: Research is needed to determine the prevalence and variables associated with the diagnosis of flatfoot, and to evaluate the validity of three footprint analysis methods for diagnosing flatfoot, using clinical diagnosis as a benchmark. METHODS: We conducted a cross-sectional study of a population-based random sample ≥ 40 years old (n = 1002) in A Coruña, Spain. Anthropometric variables, Charlson's comorbidity score, and podiatric examination (including measurement of Clarke's angle, the Chippaux-Smirak index, and the Staheli index) were used for comparison with a clinical diagnosis method using a podoscope. Multivariate regression was performed. Informed patient consent and ethical review approval were obtained. RESULTS: Prevalence of flatfoot in the left and right footprint, measured using the podoscope, was 19.0% and 18.9%, respectively. Variables independently associated with flatfoot diagnosis were age (OR 1.07), female gender (OR 3.55) and BMI (OR 1.39). The area under the receiver operating characteristic curve (AUC) showed that Clarke's angle is highly accurate in predicting flatfoot (AUC 0.94), followed by the Chippaux-Smirak (AUC 0.83) and Staheli (AUC 0.80) indices. Sensitivity values were 89.8% for Clarke's angle, 94.2% for the Chippaux-Smirak index, and 81.8% for the Staheli index, with respective positive likelihood ratios or 9.7, 2.1, and 2.0. CONCLUSIONS: Age, gender, and BMI were associated with a flatfoot diagnosis. The indices studied are suitable for diagnosing flatfoot in adults, especially Clarke's angle, which is highly accurate for flatfoot diagnosis in this population.

Clinical-pathological characteristics and prognosis of a cohort of oesophageal cancer patients: a competing risks survival analysis.

BACKGROUND: To determine the clinical course, follow-up strategies, and survival of oesophageal cancer patients using a competing risks survival analysis. METHODS: We conducted a retrospective and prospective follow-up study. The study included 180 patients with a pathological diagnosis of oesophageal cancer in A Coruña, Spain, between 2003 and 2008. The Kaplan-Meier methodology and competing risks survival analysis were used to calculate the specific survival rate. The study was approved by the Ethics Review Board (code 2011/372, CEIC Galicia). RESULTS: The specific survival rate at the first, third, and fifth years was 40.2%, 18.1%, and 12.4%, respectively. Using the Kaplan-Meier methodology, the survival rate was slightly higher after the third year of follow-up. In the multivariate analysis, poor prognosis factors were female sex (hazard ratio [HR] 1.94; 95% confidence interval [CI], 1.24-3.03), Charlson's comorbidity index (HR 1.17; 95% CI, 1.02-1.33), and stage IV tumours (HR 1.70; 95% CI, 1.11-2.59). The probability of dying decreased with surgical and oncological treatment (chemotherapy and/or radiotherapy) (HR 0.23; 95% CI, 0.12-0.45). The number of hospital consultations per year during the follow-up period, from diagnosis to the appearance of a new event (local recurrences, newly appeared metastasis, and newly appeared neoplasias) did not affect the probability of survival (HR 1.03; 95% CI, 0.92-1.15). CONCLUSIONS: The Kaplan-Meier methodology overestimates the survival rate in comparison to competing risks analysis. The variables associated with a poor prognosis are female sex, Charlson's comorbidity score and extensive tumour invasion. Type of follow-up strategy employed after diagnosis does not affect the prognosis of the disease.

Clinical predictors of major adverse cardiovascular events during long-term follow-up after carotid endarterectomy.

BACKGROUND: Those patients who undergo a carotid endarterectomy (CEA) will present a higher cardiovascular risk during follow-up than the general population. The objective of this study was to determine the prognostic factors and validate the accuracy of 3 cardiovascular risk scores as predictors of major adverse cardiovascular events (MACEs) during long-term follow-up after CEA. METHODS: Observational retrospective follow-up study with 416 CEAs conducted consecutively in 385 patients from 1994 to 2011. The primary end point was MACE, single event including myocardial infarction, stroke, and cardiovascular death. Preoperative risk factors and medical treatment at discharge were collected. A general cardiovascular risk score, the Revised Cardiac Risk Index (RCRI), was used, and 2 scores specific for CEA (Halm and Tu). Descriptive analysis and Cox regression were conducted. Informed consent from patients was obtained and approval by the ethics committee. RESULTS: The median follow-up was 4.94 years. MACEs appeared in 22.1% (95% confidence interval [CI], 18.0-26.2%) of the series during follow-up. The MACEs rate at 1 year, 3 years, and 5 years, was 3.1%, 9.3%, and 15.8%, respectively. In the Cox regression model, the MACE predictor variables were: the presence of peripheral artery disease (hazard ratio [HR], 1.69; 95% CI, 1.06-2.70) and RCRI (HR,1.61; 95% CI, 1.04-2.50). The RCRI area under the curve for predicting events, with a 2.5 cutoff point, was 0.59 with 85.9% sensitivity and a positive predictive value of 25.2%. CONCLUSIONS: Peripheral artery disease and high RCRI have an independent effect on predicting MACEs. The 3 different scores have a low ability for predicting MACEs during long-term follow-up.

Validity of clinic blood pressure compared to ambulatory monitoring in hypertensive patients in a primary care setting.

AIMS: To determine the validity of the blood pressure (BP) measurement in a primary care setting in comparison with the measurement obtained from 24-h ambulatory blood pressure monitoring (ABPM). METHODS: Patients with hypertension (n = 137) were studied in primary care. Immediately after a nurse took two measurements of each patient's BP, the ABPM device was attached. Agreement was determined using the Bland-Altman method and the Kappa index. The sensitivity, specificity, predictive values and likelihood ratios were calculated for the manual BP measurement in comparison with ABPM for the purpose of diagnosing uncontrolled BP. RESULTS: The BP values from ABPM were lower than those obtained in the examination room. The difference between the clinic measurement and the ABPM was 18.07 ± 14.6 mmHg (systolic blood pressure, SBP) and 6.3 ± 9.2 mmHg (diastolic blood pressure, DBP). The agreement between the clinic measurement and 24h-ABPM for the purpose of classifying control or uncontrolled BP was 64.2% (Kappa = 0.311). In the case of ABPM, the sensitivity of the measurement in the examination room for diagnosing uncontrolled BP was 80.36%, specificity was 53.09%, positive predictive value 54.22% and negative predictive value 70.63%. CONCLUSIONS: Clinic measurements do not have sufficient sensitivity/specificity to be recommended as a single method of BP control in primary care.

Characteristics and pattern of recurrence after curative surgery in oesophageal cancer.

BACKGROUND AND AIM: Recurrence in oesophageal cancer continues to remain high after curative surgery. The aim of this study was to determine the presence of recurrence after curative surgery during follow-up, and the associated variables. METHODS: A retrospective and prospective follow-up study in patients with an anatomical-pathological diagnosis of oesophageal cancer who underwent curative surgery (n = 57) in the health district of A Coruña (Spain) during the period 2003-2008. The calculation of recurrence-free survival was made using a competing risks survival analysis. RESULTS: Out of the 57 patients included in the study, 87.7% were men with a mean age of 61.4 ± 10.3 years. The median follow-up period was 18.5 months, during which 28 recurrences were detected (50.9%). Patients with dysphagia on diagnosis of the disease, as well as patients in stages III-IV, have a higher probability of recurrence during the follow-up period. The median disease-free interval was 8.5 months. After one year of follow up, 57.1% of the recurrences were diagnosed and 82.1% after 2 years of followup. The median post-recurrence survival rate was 4.7 months. After adjusting for a multivariate regression model, the variable with an independent effect for predicting recurrence is the TNM classification (HR = 8.49). CONCLUSIONS: The majority of the recurrences will be developed during the 2 years after surgery, with a very poor prognosis. The predictor variable for recurrence is the TMN classification.

[Prognostic factors in adult patients hospitalized for pneumonia caused by Legionella pneumophila]. / Factores pronósticos en adultos hospitalizados por neumonía causada por Legionella pneumophila.

INTRODUCTION: Legionellosis is a multisystem bacterial disease, which causes pneumonia with high mortality in patients with comorbidity and admitted in intensive care units (ICU). OBJECTIVE: Determine predictors of mortality or ICU admission. METHODS: Retrospective follow-up of patients diagnosed with Legionella pneumophila pneumonia in Complexo Hospitalario Universitario de A Coruña. Period 2000-2013 (n=240). Analysis of multivariate logistic regression was performed. RESULTS: Mean age was 57.2±15.4 years old, 88.3% were male. Average score of comorbidity (Charlson score) was 2.3±2.3. There was a clear seasonal variation. Predominant symptoms were fever (92.5%), dry cough (38.1%) and dyspnea (33.9%). Creatinine clearance was lower than 60 mL/min/1.73 m² in 29.7% and sodium<135 mEq/l in 58.3%. Admission to ICU rate was 16.3% and 10.8% needs mechanical ventilation. Inhospital mortality rate was 4.6%, rising to 23.1% in patients admitted to ICU. Variables associated to predict ICU admission were age (OR=0.96), liver disease (OR=7.13), dyspnea (OR=4.33), delirium (OR=5.86) and high levels of lactatedehydrogenase (OR=1.002). Variables associated with inhospital mortality were Charlson index (OR=1.70), mechanical ventilation (OR=31.44) and high levels of lactatedehydrogenase (OR=1.002). DISCUSSION: Younger patients with liver disease, dyspnea and confusion are more likely to be admitted to ICU. Comorbidity, mechanical ventilation and elevated LDH levels are associated with higher mortality rate.

Factors related with symptom duration until diagnosis and treatment of symptomatic colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) survival depends mostly on stage at the time of diagnosis. However, symptom duration at diagnosis or treatment have also been considered as predictors of stage and survival. This study was designed to: 1) establish the distinct time-symptom duration intervals; 2) identify factors associated with symptom duration until diagnosis and treatment. METHODS: This is a cross-sectional study of all incident cases of symptomatic CRC during 2006-2009 (795 incident cases) in 5 Spanish regions. Data were obtained from patients' interviews and reviews of primary care and hospital clinical records. MEASUREMENTS: CRC symptoms, symptom perception, trust in the general practitioner (GP), primary care and hospital examinations/visits before diagnosis, type of referral and tumor characteristics at diagnosis. Symptom Diagnosis Interval (SDI) was calculated as time from first CRC symptoms to date of diagnosis. Symptom Treatment Interval (STI) was defined as time from first CRC symptoms until start of treatment. Nonparametric tests were used to compare SDI and STI according to different variables. RESULTS: Symptom to diagnosis interval for CRC was 128 days and symptom treatment interval was 155. No statistically significant differences were observed between colon and rectum cancers. Women experienced longer intervals than men. Symptom presentation such as vomiting or abdominal pain and the presence of obstruction led to shorter diagnostic or treatment intervals. Time elapsed was also shorter in those patients that perceived their first symptom/s as serious, disclosed it to their acquaintances, contacted emergencies services or had trust in their GPs. Primary care and hospital doctor examinations and investigations appeared to be related to time elapsed to diagnosis or treatment. CONCLUSIONS: Results show that gender, symptom perception and help-seeking behaviour are the main patient factors related to interval duration. Health service performance also has a very important role in symptom to diagnosis and treatment interval. If time to diagnosis is to be reduced, interventions and guidelines must be developed to ensure appropriate examination and diagnosis during both primary and hospital care.

Utility of brief questionnaires of health-related quality of life (Airways Questionnaire 20 and Clinical COPD Questionnaire) to predict exacerbations in patients with asthma and COPD.

BACKGROUND: There is some evidence that quality of life measured by long disease-specific questionnaires may predict exacerbations in asthma and COPD, however brief quality of life tools, such as the Airways Questionnaire 20 (AQ20) or the Clinical COPD Questionnaire (CCQ), have not yet been evaluated as predictors of hospital exacerbations. OBJECTIVES: To determine the ability of brief specific health-related quality of life (HRQoL) questionnaires (AQ20 and CCQ) to predict emergency department visits (ED) and hospitalizations in patients with asthma and COPD, and to compare them to longer disease-specific questionnaires, such as the St George´s Respiratory Questionnaire (SGRQ), the Chronic Respiratory Disease Questionnaire (CRQ) and the Asthma Quality of Life Questionnaire (AQLQ). METHODS: We conducted a two-year prospective cohort study of 208 adult patients (108 asthma, 100 COPD). Baseline sociodemographic, clinical, functional and psychological variables were assessed. All patients completed the AQ20 and the SGRQ. COPD patients also completed the CCQ and the CRQ, while asthmatic patients completed the AQLQ. We registered all exacerbations that required ED or hospitalizations in the follow-up period. Differences between groups (zero ED visits or hospitalizations versus ≥ 1 ED visits or hospitalizations) were tested with Pearson´s X(2) or Fisher´s exact test for categorical variables, ANOVA for normally distributed continuous variables, and Mann-Whitney U test for non-normally distributed variables. Logistic regression analyses were performed to estimate the predictive ability of each HRQoL questionnaire. RESULTS: In the first year of follow-up, the AQ20 scores predicted both ED visits (OR: 1.19; p = .004; AUC 0.723) and hospitalizations (OR: 1.21; p = .04; AUC 0.759) for asthma patients, and the CCQ emerged as independent predictor of ED visits in COPD patients (OR: 1.06; p = .036; AUC 0.651), after adjusting for sociodemographic, clinical, and psychological variables. Among the longer disease-specific questionnaires, only the AQLQ emerged as predictor of ED visits in asthma patients (OR: 0.9; p = .002; AUC 0.727). In the second year of follow-up, none of HRQoL questionnaires predicted exacerbations. CONCLUSIONS: AQ20 predicts exacerbations in asthma and CCQ predicts ED visits in COPD in the first year of follow-up. Their predictive ability is similar to or even higher than that of longer disease-specific questionnaires.

Diagnostic and treatment delay, quality of life and satisfaction with care in colorectal cancer patients: a study protocol.

BACKGROUND: Due to recent improvements in colorectal cancer survival, patient-reported outcomes, including health-related quality of life and satisfaction with care, have become well-established endpoints to determine the impact of the disease on the lives of patients.The aim of this study is to determine prospectively, in a cohort of colorectal cancer incident cases: a) health-related quality of life, b) satisfaction with hospital-based care, and c) functional status. A secondary objective is to determine whether diagnostic/therapeutic delay influence quality of life or patients' satisfaction levels. METHODS/DESIGN: Single-centre prospective follow-up study of colorectal cancer patients diagnosed during the period 2011-2012 (n = 375).This project was approved by the corresponding ethics review board, and informed consent is obtained from each patient. After diagnosis, patients are interviewed by a trained nurse, obtaining information on sociodemographic characteristics, family history of cancer, first symptoms, symptom perception and reaction to early symptoms. Quality of life is assessed with the EORTC QLQ-C30 and QLQ-CR29 questionnaires, and patients' satisfaction with care is determined using the EORTC IN-PATSAT32. Functional status is measured with the Karnofsky Performance Status Scale.Clinical records are also reviewed to collect information on comorbidity, tumour characteristics, treatment, hospital consultations and exploratory procedures.Symptoms-to-diagnosis interval is defined as the time from the date of first symptoms until the cytohistological confirmation of cancer. Treatment delay is defined as the time between diagnosis and surgical treatment.All the patients will be followed-up for a maximum of 2 years. For survivors, assessments will be re-evaluated at one and two years after the diagnosis.Multiple linear/logistic regression models will be used to identify variables associated with the patients' functional status, quality of life and satisfaction with care score. Changes in quality of life over time will be analysed with linear mixed-effects regression models. DISCUSSION: The results will provide a deeper understanding of the impact of colorectal cancer from a more patient-centred approach, allowing us to identify groups of patients in need of additional attention, as well as areas for improvement. Special attention will be given to the relationship between diagnostic/therapeutic delay and patients' quality of life and satisfaction with the care received.

Impact of physical and psychosocial factors on disability caused by lumbar pain amongst fishing sector workers.

Functional disability due to lumbar pain should be considered from the biopsychosocial model. There is inconclusive evidence as to whether the key determining factors in this form of disability are psychosocial or physical. Our aim is to identify variables that cause functional disability due to lumbar pain amongst shellfish gatherers in Galicia by means of a cross-sectional survey. Participants (N = 929) completed a self-administered, paper-based questionnaire including sociodemographic and lifestyle issues, as well as the nature of the lumbar pain, the presence of musculoskeletal pain in other regions of the body, the Roland-Morris Disability Questionnaire (RMDQ) and SF-36. Univariate examination, ROC curve and logistic regression analyses were performed. Most of these workers are women (98.7 %), with a mean age of 50.6 years. The point-prevalence of lumbar pain stands at 65.5 %. The RMDQ mean was 4.9 (SD = 4.7). In the logistic regression analysis, the variables associated with disability (RMDQ > median) were age (OR = 1.04), physical exercise (OR = 0.57), pain intensity (OR = 1.16), the number of regions of musculoskeletal pain (OR = 1.24) and mental health (SF-36) (OR = -0.95). Functional disability is determined by the physical nature of the pain and mental health attributes, although the former has a greater impact. In decreasing order of importance, functional disability is attributable to the presence of lower back pain, the number of regions of musculoskeletal pain, the intensity of that pain and age. Regular physical exercise and better mental health have a protective effect on disability.

Electrocardiographic abnormalities in centenarians: impact on survival.

BACKGROUND: The centenarian population is gradually increasing, so it is becoming more common to see centenarians in clinical practice. Electrocardiogram abnormalities in the elderly have been reported, but several methodological biases have been detected that limit the validity of their results. The aim of this study is to analyse the ECG abnormalities in a prospective study of the centenarian population and to assess their impact on survival. METHOD: We performed a domiciliary visit, where a medical history, an ECG and blood analysis were obtained. Barthel index (BI), cognitive mini-exam (CME) and Charlson index (ChI) were all determined. Patients were followed up by telephone up until their death. RESULTS: A total of 80 centenarians were studied, 26 men and 64 women, mean age 100.8 (SD 1.3). Of these, 81% had been admitted to the hospital at least once in the past, 81.3% were taking drugs (mean 3.3, rank 0-11). ChI was 1.21 (SD 1.19). Men had higher scores both for BI (70 -SD 34.4- vs. 50.4 -SD 36.6-, P = .005) and CME (16.5 -SD 9.1- vs. 9.1 -SD 11.6-, P = .008); 40.3% of the centenarians had anaemia, 67.5% renal failure, 13% hyperglycaemia, 22.1% hypoalbuminaemia and 10.7% dyslipidaemia, without statistically significant differences regarding sex. Only 7% had a normal ECG; 21 (26.3%) had atrial fibrillation (AF), 30 (37.5%) conduction defects and 31 (38.8%) abnormalities suggestive of ischemia, without sex-related differences. A history of heart disease was significantly associated with the presence of AF (P = .002, OR 5.2, CI 95% 1.8 to 15.2) and changes suggestive of ischemia (P = .019, OR 3.2, CI 95% 1.2-8.7). Mean survival was 628 days (SD 578.5), median 481 days. Mortality risk was independently associated with the presence of AF (RR 2.0, P = .011), hyperglycaemia (RR 2.2, P = .032), hypoalbuminaemia (RR 3.5, P < .001) and functional dependence assessed by BI (RR 1.8, P = .024). CONCLUSION: Although ECG abnormalities are common in centenarians, they are not related to sex, functional capacity or cognitive impairment. The only abnormality that has an impact on survival is AF.

Incidence of cardiovascular events after kidney transplantation and cardiovascular risk scores: study protocol.

BACKGROUND: Cardiovascular disease (CVD) is the major cause of death after renal transplantation. Not only conventional CVD risk factors, but also transplant-specific risk factors can influence the development of CVD in kidney transplant recipients. The main objective of this study will be to determine the incidence of post-transplant CVD after renal transplantation and related factors. A secondary objective will be to examine the ability of standard cardiovascular risk scores (Framingham, REGICOR, SCORE, and DORICA) to predict post-transplantation cardiovascular events in renal transplant recipients, and to develop a new score for predicting the risk of CVD after kidney transplantation. METHODS/DESIGN: Observational prospective cohort study of all kidney transplant recipients in the A Coruna Hospital (Spain) in the period 1981-2008 (2059 transplants corresponding to 1794 patients). The variables included will be: donor and recipient characteristics, chronic kidney disease-related risk factors, pre-transplant and post-transplant cardiovascular risk factors, routine biochemistry, and immunosuppressive, antihypertensive and lipid-lowering treatment. The events studied in the follow-up will be: patient and graft survival, acute rejection episodes and cardiovascular events (myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances and peripheral vascular disease). Four cardiovascular risk scores were calculated at the time of transplantation: the Framingham score, the European Systematic Coronary Risk Evaluation (SCORE) equation, and the REGICOR (Registre Gironi del COR (Gerona Heart Registry)), and DORICA (Dyslipidemia, Obesity, and Cardiovascular Risk) functions. The cumulative incidence of cardiovascular events will be analyzed by competing risk survival methods. The clinical relevance of different variables will be calculated using the ARR (Absolute Risk Reduction), RRR (Relative Risk Reduction) and NNT (Number Needed to Treat). The ability of different cardiovascular risk scores to predict cardiovascular events will be analyzed by using the c index and the area under ROC curves. Based on the competing risks analysis, a nomogram to predict the probability of cardiovascular events after kidney transplantation will be developed. DISCUSSION: This study will make it possible to determine the post-transplant incidence of cardiovascular events in a large cohort of renal transplant recipients in Spain, to confirm the relationship between traditional and transplant-specific cardiovascular risk factors and CVD, and to develop a score to predict the risk of CVD in these patients.