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Se presentan los resultados de la aplicación del Cuestionario GIQLI sobre Calidad de Vida Gastrointestinal a tres colectivos de sujetos sanos: uno consumidor de yogur pasteurizado, otro de yogur sin pasteurizar, en comparación con un tercer grupo control de no consumidores. Las cifras de los tres colectivos son congruentes con otros estudios de validación del Cuestionario sin encontrar diferencias valorables entre los tres grupos.We present the outcomes of GIQLI Questionnaire (Gastrointestinal Quality of Life) application to three groups of healthy individuals: the first one, consumers of pasteurized yogurt; the second one, consumers of non-pasteurized yogurt; and the third one, a comparison control group of non-consumers. The results from the three groups are in agreement with other validation studies of the Questionnaire, not finding significant differences between groups.

Se presentan los resultados de la aplicación del Cuestionario GIQLI sobre Calidad de Vida Gastrointestinal a tres colectivos de sujetos sanos: uno consumidor de yogur pasteurizado, otro de yogur sin pasteurizar, en comparación con un tercer grupo control de no consumidores. Las cifras de los tres colectivos son congruentes con otros estudios de validación del Cuestionario sin encontrar diferencias valorables entre los tres grupos.

Abstract: The therapeutic approach is crucial to prostate cancer prognosis. We describe treatments and outcomes for a Spanish cohort of patients with prostate cancer during the first 12 months after diagnosis and identify the factors that influenced the treatment they received.This multicenter prospective cohort study included patients with prostate cancer followed up for 12 months after diagnosis. Treatment was stratified by factors such as hospital, age group (<70 and ≥70 years), and D'Amico cancer risk classification. The outcomes were Eastern Cooperative Oncology Group (ECOG) performance status, adverse events (AEs), and mortality. The patient characteristics associated with the different treatment modalities were analyzed using multivariate logistic regression.We included 470 men from 7 Spanish tertiary hospitals (mean (standard deviation) age 67.8 (7.6) years), 373 (79.4%) of which received treatment (alone or in combination) as follows: surgery (n = 163; 34.7%); radiotherapy (RT) (n = 149; 31.7%); and hormone therapy (HT) (n = 142; 30.2%). The remaining patients (n = 97) were allocated to no treatment, that is, watchful waiting (14.0%) or active surveillance (5.7%). HT was the most frequently administered treatment during follow-up and RT plus HT was the most common therapeutic combination. Surgery was more frequent in patients aged <70, with lower histologic tumor grades, Gleason scores <7, and lower prostate-specific antigen levels; while RT was more frequent in patients aged ≥70 with histologic tumor grade 4, and higher ECOG scores. HT was more frequent in patients aged ≥70, with histologic tumor grades 3 to 4, Gleason score ≥8, ECOG ≥1, and higher prostate-specific antigen levels. The number of fully active patients (ECOG score 0) decreased significantly during follow-up, from 75.3% at diagnosis to 65.1% at 12 months (P < .001); 230 (48.9%) patients had at least 1 AE, and 12 (2.6%) patients died.Surgery or RT were the main curative options. A fifth of the patients received no treatment. Palliative HT was more frequently administered to older patients with higher tumor grades and higher Gleason scores. Close to half of the patients experienced an AE related to their treatment., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Neuro-reflexotherapy (NRT) is a proven effective, invasive treatment for neck and back pain. To assess physician-related variability in results, data from post-implementation surveillance of 9023 patients treated within the Spanish National Health Service by 12 physicians were analyzed. Separate multi-level logistic regression models were developed for spinal pain (SP), referred pain (RP), and disability. The models included all patient-related variables predicting response to NRT and physician-related variables. The Intraclass Correlation Coefficient (ICC) and the Median Odds Ratio (MOR) were calculated. Adjusted MOR (95% CI) was 1.70 (1.47; 2.09) for SP, 1.60 (1.38; 1.99) for RP, and 1.65 (1.42; 2.03) for disability. Adjusted ICC (95%CI) values were 0.08 (0.05; 0.15) for SP, 0.07 (0.03; 0.14) for RP, and 0.08 (0.04; 0.14) for disability. In the sensitivity analysis, in which the 6920 patients treated during the physicians' training period were excluded, adjusted MOR was 1.38 (1.17; 1.98) for SP, 1.37 (1.12; 2.31) for RP, and 1.25 (1.09; 1.79) for disability, while ICCs were 0.03 (0.01; 0.14) for SP, 0.03 (0.00; 0.19) for RP, and 0.02 (0.00; 0.10) for disability. In conclusion, the variability in results obtained by different NRT-certified specialists is reasonable. This suggests that current training standards are appropriate.

Competing Interests: All authors declare nothing to disclose.

Purpose: Variations in clinical characteristics and management and in the mortality of mechanically ventilated patients have not been sufficiently evaluated. We hypothesized that mortality shows a variability associated with country after adjustment for clinical characteristics and management., Methods: Analysis of four studies carried out at 6-year intervals over an 18-year period. The studies included 26,024 patients (5183 in 1998, 4968 in 2004, 8108 in 2010, and 7765 in 2016) admitted to 1253 units from 38 countries. The primary outcome was 28-day mortality. We performed analyses using multilevel logistic modeling with mixed-random effects, including country as a random variable. To evaluate the effect of management strategies on mortality, a mediation analysis was performed., Results: Adjusted 28-day mortality decreased significantly over time (first study as reference): 2004: odds ratio 0.82 (95% confidence interval [CI] 0.72-0.93); 2010: 0.63 (95% CI 0.53-0.75); 2016: 0.49 (95% CI 0.39-0.61). A protective ventilatory strategy and the use of continuous sedation mediated a moderate fraction of the effect of time on mortality in patients with moderate hypoxemia and without hypoxemia, respectively. Logistic multilevel modeling showed a significant effect of country on mortality: median odds ratio (MOR) in 1998: 2.02 (95% CI 1.57-2.48); in 2004: 1.76 (95% CI 1.47-2.06); in 2010: 1.55 (95% CI 1.37-1.74), and in 2016: 1.39 (95% CI 1.25-1.54)., Conclusions: These findings suggest that country could contribute, independently of confounder variables, to outcome. The magnitude of the effect of country decreased over time. Clinical trials registered with http://www.clinicaltrials.gov (NCT02731898).

The Grupo Español de Linfomas y Trasplantes de Médula Ósea International Prognostic Index (GELTAMO-IPI) stratifies four risk groups in diffuse large B cell lymphoma (DLBCL) patients treated with immunochaemotherapy: low (LR), low-intermediate (LIR), high-intermediate (HIR), and high (HR). The present study explores the effect of GELTAMO-IPI in the DLBCL subtypes defined by the immunohistochaemistry-based Hans algorithm, Germinal Centre B (GCB) and non-GCB. A multivariate Cox regression model including GELTAMO-IPI risk groups, cell of origin (COO) subtypes and their product was developed to evaluate interaction between the two variables. The COO subtype was available in 839 patients (380 GCB; 459 non-GCB) and both the GELTAMO-IPI and the COO subtype in 780 (353 GCB; 427 non-GCB). There were no differences in 5-year overall survival (OS) between the two subtypes. The Cox model revealed interaction between the GELTAMO-IPI risk groups and the COO subtypes (P = 0·005), indicating that GELTAMO-IPI has a different effect in the two subtypes. Three risk groups were stratified in both COO subtypes: in the GCB subtype, LR, LIR and the combined HIR+HR had 5-year OS of 100%, 75% and 52%, respectively. In the non-GCB subtype, LR, the combined LIR+HIR and HR had a 5-year OS of, 97%, 82% and 35% respectively. GELTAMO-IPI identifies a genuine poor outcome group of patients in the DLBCL non-GCB subtype., (© 2018 British Society for Haematology and John Wiley & Sons Ltd.)

Objectives: To assess the impact of a history of liver metastases on survival in patients undergoing surgery for lung metastases from colorectal carcinoma., Methods: We reviewed recent studies identified by searching MEDLINE and EMBASE using the Ovid interface, with the following search terms: lung metastasectomy, pulmonary metastasectomy, lung metastases and lung metastasis, supplemented by manual searching. Inclusion criteria were that the research concerned patients with lung metastases from colorectal cancer undergoing surgery with curative intent, and had been published between 2007 and 2014. Exclusion criteria were that the paper was a review, concerned surgical techniques themselves (without follow-up), and included patients treated non-surgically. Using Stata 14, we performed aggregate data and individual data meta-analysis using random-effect and Cox multilevel models respectively., Results: We collected data on 3501 patients from 17 studies. The overall median survival was 43 months. In aggregate data meta-analysis, the hazard ratio for patients with previous liver metastases was 1.19 (95% CI 0.90-1.47), with low heterogeneity (I 2 4.3%). In individual data meta-analysis, the hazard ratio for these patients was 1.37 (95% CI 1.14-1.64; p < 0.001). Multivariate analysis identified the following factors significantly affecting survival: tumour-infiltrated pulmonary lymph nodes (p < 0.001), type of resection (p = 0.005), margins (p < 0.001), carcinoembryonic antigen levels (p < 0.001), and number and size of lung metastases (both p < 0.001)., Conclusions: A history of liver metastases is a negative prognostic factor for survival in patients with lung metastases from colorectal cancer. We registered the meta-analysis protocol in PROSPERO (CRD42015017838)., (Copyright © 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Background: The objective of this study was to estimate the association between sleep quality (SQ) and improvements in low back pain (LBP) and disability, among patients treated for LBP in routine practice., Methods: This prospective cohort study included 461 subacute and chronic LBP patients treated in 11 specialized centres, 14 primary care centres and eight physical therapy practices across 12 Spanish regions. LBP, leg pain, disability, catastrophizing, depression and SQ were assessed through validated questionnaires upon recruitment and 3 months later. Logistic regression models were developed to assess: (1) the association between the baseline score for SQ and improvements in LBP and disability at 3 months, and (2) the association between improvement in SQ and improvements in LBP and disability during the follow-up period., Results: Seventy-three per cent of patients were subacute. Median scores at baseline were four points for both pain and disability, as assessed with a visual analog scale and the Roland-Morris Questionnaire, respectively. Regression models showed (OR [95% CI]) that baseline SQ was not associated with improvements in LBP (0.99 [0.94; 1.06]) or in disability (0.99 [0.93; 1.05]), although associations existed between 'improvement in SQ' and 'improvement in LBP' (4.34 [2.21; 8.51]), and 'improvement in SQ' and 'improvement in disability' (4.60 [2.29; 9.27])., Conclusions: Improvement in SQ is associated with improvements in LBP and in disability at 3-month follow-up, suggesting that they may reflect or be influenced by common factors. However, baseline SQ does not predict improvements in pain or disability., Significance: In clinical practice, sleep quality, low back pain and disability are associated. However, sleep quality at baseline does not predict improvement in pain and disability., (© 2017 European Pain Federation - EFIC®.)

Objective: We performed a cohort study in seven hospitals in Spain to determine the clinical characteristics of incident patients with bladder cancer, the diagnostic process, and the conditions that might affect health care interval times., Results: 314 patients with bladder cancer were included, 70.3 (Standard Deviation [SD] 11.2) years old and 85.0% male. Clinical stage was T1 in 45.9% of patients. The median interval time between first consultation and diagnosis was of 104.0 days (Inter quartile range [IQR]:112.0; range from 0 to 986), being shorter for those patients who attended a hospital for their first consultation. The median interval time between diagnosis and first treatment was of 0.0 days (IQR: 0.0; range from 0 to 366), being longer when the patient had a pathologic tumor stage ≥ T2a.

Introduction and Objectives: Thrombus aspiration allows analysis of intracoronary material in patients with ST-segment elevation myocardial infarction. Our objective was to characterize this material by immunohistology and to study its possible association with patient progress., Methods: This study analyzed a prospective cohort of 142 patients undergoing primary angioplasty with positive coronary aspiration. Histological examination of aspirated samples included immunohistochemistry stains for the detection of plaque fragments. The statistical analysis comprised histological variables (thrombus age, degree of inflammation, presence of plaque), the patients' clinical and angiographic features, estimation of survival curves, and logistic regression analysis., Results: Among the histological markers, only the presence of plaque (63% of samples) was associated with postinfarction clinical events. Factors associated with 5-year event-free survival were the presence of plaque in the aspirate (82.2% vs 66.0%; P = .033), smoking (82.5% smokers vs 66.7% nonsmokers; P = .036), culprit coronary artery (83.3% circumflex or right coronary artery vs 68.5% anterior descending artery; P = .042), final angiographic flow (80.8% II-III vs 30.0% 0-I; P < .001) and left ventricular ejection fraction ≥ 35% at discharge (83.7% vs 26.7%; P < .001). On multivariable Cox regression analysis with these variables, independent predictors of event-free survival were the presence of plaque (hazard ratio, 0.37; 95%CI, 0.18-0.77; P = .008), and left ventricular ejection fraction (hazard ratio, 0.92; 95%CI, 0.88-0.95; P < .001)., Conclusions: The presence of plaque in the coronary aspirate of patients with ST elevation myocardial infarction may be an independent prognostic marker. CD68 immunohistochemical stain is a good method for plaque detection., (Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

The study included 1848 diffuse large B-cell lymphoma (DLBCL)patients treated with chemotherapy/rituximab. The aims were to validate the National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI) and explore the effect of adding high Beta-2 microglobulin (β2M), primary extranodal presentation and intense treatment to the NCCN-IPI variables in order to develop an improved index. Comparing survival curves, NCCN-IPI discriminated better than IPI, separating four risk groups with 5-year overall survival rates of 93%, 83%, 67% and 49%, but failing to identify a true high-risk population. For the second aim the series was split into training and validation cohorts: in the former the multivariate model identified age, lactate dehydrogenase, Eastern Cooperative Oncology Group performance status, Stage III-IV, and β2M as independently significant, whereas the NCCN-IPI-selected extranodal sites, primary extranodal presentation and intense treatments were not. These results were confirmed in the validation cohort. The Grupo Español de Linfomas/Trasplante de Médula ósea (GELTAMO)-IPI developed here, with 7 points, significantly separated four risk groups (0, 1-3, 4 or ≥5 points) with 11%, 58%, 17% and 14% of patients, and 5-year overall survival rates of 93%, 79%, 66% and 39%, respectively. In the comparison GELTAMO IPI discriminated better than the NCCN-IPI. In conclusion, GELTAMO-IPI is more accurate than the NCCN-IPI and has statistical and practical advantages in that the better discrimination identifies an authentic high-risk group and is not influenced by primary extranodal presentation or treatments of different intensity., (© 2017 John Wiley & Sons Ltd.)

Solid organ transplantation is the treatment of choice for patients with end-stage organ disease. However, organ transplantation can stress the cardiovascular system and decrease immune surveillance, leading to early mortality and graft loss due to multiple underlying comorbidities. Clinical end-points in transplant include death and graft failure. Thus, generating accurate predictive models through regression models is crucial to test for definitive clinical post-transplantation end-points. Survival predictive models should assemble efficient surrogate markers or prognostic factors to generate a minimal set of variables derived from a proper modeling strategy through regression models. However, a few critical points should be considered when reporting survival analyses and regression models to achieve proper discrimination and calibration of the predictive models. Additionally, population-based risk scores may underestimate risk prediction in transplant. The application of predictive models in these patients should therefore incorporate both classical and non-classical risk factors, as well as community-based health indicators and transplant-specific factors to quantify the outcomes in terms of survival properly. This review focuses on assessment of clinical end-points in transplant through regression models by combining predictive and surrogate variables, and considering key points in these analyses to accurately predict definitive end-points, which could aid clinicians in decision making., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: Nurse activity is determined by the characteristics of nursing staff. The objective was to determine the impact of Primary Health Care (PHC) nursing workforce characteristics on the control of Diabetes Mellitus (DM) in adults., Methods: Cross-sectional analytical study. Administrative and clinical registries and questionnaire PES-Nursing Work Index from PHC nurses. Participants 44.214 diabetic patients in two health zones within the Community of Madrid, North-West Zone (NWZ) with higher socioeconomic situation and South-West Zone (SWZ) with lower socioeconomic situation, and their 507 reference nurses. Analyses were performed to multivariate multilevel logistic regression models., Primary Outcome Measure: Poor DM control (figures equal or higher than 7% HbA1c)., Results: The prevalence of poor DM control was 40.1% [CI95%: 38.2-42.1]. There was a risk of 25% more of poor control if the patient changed centre and of 27% if changed of doctor-nurse pair. In the multilevel multivariate regression models: in SWZ increasing the ratio of patients over 65 years per nurse increased the poor control (OR=1.00008 [CI95%:1.00006-1.001]); and higher proportion of patients whose Hb1Ac was not measured at the centre contributed to poor DM control (OR=5.1 [CI95%:1.6-15.6]). In two models for health zone, the economic immigration condition increased poor control, in SWZ (OR=1.3 [CI95%:1.03-1.7]); and in NWZ (OR=1.29 [CI95%:1.03-1.6])., Conclusions: Higher 65 years old patients ratio per nurse, economic immigration condition and a higher proportion of patients whose Hb1Ac was not measured contribute to worse DM control.

Objective: To determine the impact of Primary Health Care (PHC) nursing workforce characteristics and of the clinical practice environment (CPE) perceived by nurses on the control of high-blood pressure (HBP)., Design: Cross-sectional analytical study., Setting: Administrative and clinical registries of hypertensive patients from PHC information systems and questionnaire from PHC nurses., Participants: 76,797 hypertensive patients in two health zones within the Community of Madrid, North-West Zone (NWZ) with a higher socioeconomic situation and South-West Zone (SWZ) with a lower socioeconomic situation, and 442 reference nurses. Segmented analyses by area were made due to their different socioeconomic characteristics., Primary Outcome Measure: Poor HBP control (adequate figures below the value 140/90 mm Hg) associated with the characteristics of the nursing workforce and self-perceived CPE., Results: The prevalence of poor HBP control, estimated by an empty multilevel model, was 33.5% (95% CI 31.5% to 35.6%). In the multilevel multivariate regression models, the perception of a more favourable CPE was associated with a reduction in poor control in NWZ men and SWZ women (OR=0.99 (95% CI 0.98 to 0.99)); the economic immigration conditions increased poor control in NWZ women (OR=1.53 (95% CI 1.24 to 1.89)) and in SWZ, both men (OR=1.89 (95% CI 1.43 to 2.51)) and women (OR=1.39 (95% CI 1.09 to 1.76)). In all four models, increasing the annual number of patient consultations was associated with a reduction in poor control (NWZ women: OR=0.98 (95% CI0.98 to 0.99); NWZ men: OR=0.98 (95% CI 0.97 to 0.99); SWZ women: OR=0.98 (95% CI 0.97 to 0.99); SWZ men: OR=0.99 (95% CI 0.97 to 0.99)., Conclusions: A CPE, perceived by PHC nurses as more favourable, and more patient-nurse consultations, contribute to better HBP control. Economic immigration condition is a risk factor for poor HBP control. Health policies oriented towards promoting positive environments for nursing practice are needed., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Systematic reviews of diagnostic validity have been proposed as the best methodological tool to integrate all the available evidence and to help physicians decide whether to use a given diagnostic test. These studies aim to synthesize the results obtained in different primary studies into a couple of indices, generally sensitivity and specificity, or into a summary receiver operating characteristic (ROC) curve. Although there is a certain parallelism with reviews about the efficacy of therapeutic interventions, reviews of diagnostic validity have certain peculiarities that add complexity to the analysis and interpretation of the results. This article emphasizes the methodological aspects that make it possible to critically assess the extent to which the results of a review of the validity of diagnostic tests are valid and provides rudimentary knowledge of the statistics necessary to understand the results., (Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Previous studies have demonstrated significant variability in the processes of care and outcomes of chronic obstructive pulmonary disease (COPD) exacerbations. The AUDIPOC is a Spanish nationwide clinical audit that identified large between-hospital variations in care and clinical outcomes. Here, we test the hypothesis that these variations can be attributed to either patient characteristics, hospital characteristics and/or the so-called hospital-clustering effect, which indicates that patients with similar characteristics may experience different processes of care and outcomes depending on the hospital to which they are admitted., Methods: A clinical audit of 5178 COPD patients consecutively admitted to 129 Spanish public hospitals was performed, with a 90-day follow-up. Multilevel regression analysis was conducted to model the probability of patients experiencing adverse outcomes. For each outcome, an empty model (with no independent variables) was fitted to assess the clustering effect, followed by a model adjusted for the patient- and hospital-level covariables. The hospital-clustering effect was estimated using the intracluster correlation coefficient (ICC); the cluster heterogeneity was estimated with the median odds ratio (MOR), and the coefficients of predictors were estimated with the odds ratio (OR)., Results: In the empty models, the ICC (MOR) for inpatient mortality and the follow-up mortality and readmission were 0.10 (1.80), 0.08 (1.65) and 0.01 (1.24), respectively. In the adjusted models, the variables that most represented the patients' clinical conditions and interventions were identified as outcome predictors and further reduced the hospital variations. By contrast, the resource factors were primarily unrelated with outcomes., Conclusions: This study demonstrates a noteworthy reduction in the observed crude between-hospital variation in outcomes after accounting for the hospital-cluster effect and the variables representing patient's clinical conditions. This emphasises the predictor importance of the patients' clinical conditions and interventions, and understates the impacts of hospital resources and organisational factors., (© 2015 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.)

Purpose: There are limited data available about the role of sedation and analgesia during noninvasive positive pressure ventilation (NPPV). The objective of study was to estimate the effect of analgesic or sedative drugs on the failure of NPPV., Methods: We studied patients who received at least 2 h of NPPV as first-line therapy in a prospective observational study carried out in 322 intensive care units from 30 countries. A marginal structural model (MSM) was used to analyze the association between the use of analgesic or sedative drugs and NPPV failure (defined as need for invasive mechanical ventilation)., Results: 842 patients were included in the analysis. Of these, 165 patients (19.6%) received analgesic or sedative drugs at some time during NPPV; 33 of them received both. In the adjusted analysis, the use of analgesics (odds ratio 1.8, 95% confidence interval 0.6-5.4) or sedatives (odds ratio 2.8, 95% CI 0.85-9.4) alone was not associated with NPPV failure, but their combined use was associated with failure (odds ratio 5.7, 95% CI 1.8-18.4)., Conclusions: Slightly less than 20% of patients received analgesic or sedative drugs during NPPV, with no apparent effect on outcome when used alone. However, the simultaneous use of analgesics and sedatives may be associated with failure of NPPV.

Objective: To assess whether sleep quality (SQ) at baseline is associated with improvement in pain and disability at 3 months., Materials and Methods: Four hundred twenty-two subacute and chronic patients with neck pain (NP) were recruited in 32 physiotherapy, primary care, and specialized centers. NP, referred pain, disability, catastrophizing, depression, and SQ were assessed through validated questionnaires, upon recruitment and 3 months later. Correlations between baseline scores were calculated through the Spearman coefficient. Improvements in NP, disability, and SQ were defined as a reduction of ≥30% of baseline score. Six estimative logistic regression models were developed to assess the association between baseline SQ and improvement of NP, baseline SQ and improvement of disability, baseline NP and improvement of SQ, baseline disability and improvement of SQ, the evolutions of NP and SQ, and the evolutions of disability and SQ., Results: Most patients were subacute and mildly impaired. Regression models showed that better SQ at baseline was associated with improvement of NP (odds ratio=0.91 [95% confidence interval, 0.83-0.99]), but not disability (1.04 [0.95-1.13]); the improvement of SQ was associated with more severe NP at baseline (1.26 [1.07-1.49)], but not with baseline disability (0.99 [0.97-1.02]); and that improvement in SQ was associated with improvements in NP (3.48 [1.68-7.20]), and disability (5.02 [2.39-10.11])., Discussion: NP is less likely to improve in patients with poorer SQ, irrespective of age, sex, catastrophizing, depression, or treatments prescribed for NP. Future studies should confirm these results with more severely impaired patients.

Background: Little is known about the healthcare process for patients with prostate cancer, mainly because hospital-based data are not routinely published. The main objective of this study was to determine the clinical characteristics of prostate cancer patients, the, diagnostic process and the factors that might influence intervals from consultation to diagnosis and from diagnosis to treatment., Methods: We conducted a multicentre, cohort study in seven hospitals in Spain. Patients' characteristics and diagnostic and therapeutic variables were obtained from hospital records and patients' structured interviews from October 2010 to September 2011. We used a multilevel logistic regression model to examine the association between patient care intervals and various variables influencing these intervals (age, BMI, educational level, ECOG, first specialist consultation, tumour stage, PSA, Gleason score, and presence of symptoms) and calculated the odds ratio (OR) and the interquartile range (IQR). To estimate the random inter-hospital variability, we used the median odds ratio (MOR)., Results: 470 patients with prostate cancer were included. Mean age was 67.8 (SD: 7.6) years and 75.4% were physically active. Tumour size was classified as T1 in 41.0% and as T2 in 40% of patients, their median Gleason score was 6.0 (IQR:1.0), and 36.1% had low risk cancer according to the D'Amico classification. The median interval between first consultation and diagnosis was 89 days (IQR:123.5) with no statistically significant variability between centres. Presence of symptoms was associated with a significantly longer interval between first consultation and diagnosis than no symptoms (OR:1.93, 95%CI 1.29-2.89). The median time between diagnosis and first treatment (therapeutic interval) was 75.0 days (IQR:78.0) and significant variability between centres was found (MOR:2.16, 95%CI 1.45-4.87). This interval was shorter in patients with a high PSA value (p = 0.012) and a high Gleason score (p = 0.026)., Conclusions: Most incident prostate cancer patients in Spain are diagnosed at an early stage of an adenocarcinoma. The period to complete the diagnostic process is approximately three months whereas the therapeutic intervals vary among centres and are shorter for patients with a worse prognosis. The presence of prostatic symptoms, PSA level, and Gleason score influence all the clinical intervals differently.

Objectives: Acute kidney injury (AKI) after cardiac surgery is associated with adverse patient outcome. A new definition and staging system for AKI based on creatinine kinetics (CKs) has been proposed recently. Their proponents hypothesize that early absolute increases in serum creatinine (sCr) after kidney injury are superior to percentage increases, especially in patients with chronic kidney disease (CKD). The aims of our study were to measure agreement between CK definition and the current consensus definition [risk, injury, failure, loss and end-stage renal disease (RIFLE) system], and to compare time to diagnosis and prognostic value between both systems., Methods: Retrospective cohort study. Agreement on AKI diagnosis by both classifications, time to diagnosis and prognostic value of both systems were compared in cardiac surgeries performed during a 6-year period (2002-2007) in a single centre., Results: We found substantial agreement between both classifications (0.67). More patients were diagnosed with AKI by the CK definition than by RIFLE criteria both globally (28.2 vs 13.9%) and in every category (16.5 vs 8.4% for CK-1 vs RIFLE-R; 8.4 vs 3.6% for CK-2 vs RIFLE-I and 3.2 vs 2.0% for CK-3 vs RIFLE-F). Time to diagnosis was shorter for the CK definition (1.8 vs 2.5 days). Prognostic value in terms of information about in-hospital death and need for renal replacement was comparable between classifications., Conclusions: In cardiac surgery, the CK definition and classification system showed substantial agreement with the current standard, was more sensitive than RIFLE and detected AKI earlier without loss of prognostic information., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The Godelieve Denys-Struyf method (GDS) is a motor learning intervention that may be applied in group or individualized sessions., Objective: The study objective was to compare the effectiveness of routine physical therapy, group GDS (GDS-G) sessions, and group and individualized GDS (GDS-I) sessions., Design: This was a cluster randomized controlled trial., Setting: The study took place in 21 primary care physical therapy units ("clusters") of the Spanish National Health Service (SNHS)., Participants: The participants were 461 people with subacute and chronic low back pain (LBP)., Intervention: Clusters were randomized into 3 groups. All participants received medical treatment and a 15-minute group education session on active management. Additional interventions were as follows: control (fifteen 40-minute sessions of transcutaneous electrical nerve stimulation, microwave treatment, and standardized exercises), GDS-G (eleven 50-minute group GDS sessions), and GDS-I (the same 11 sessions plus four 50-minute individualized GDS sessions)., Measurements: Primary outcomes at baseline and 2, 6, and 12 months later were LBP and pain referred down the leg (separate pain intensity numeric rating scales) and disability (Roland-Morris Questionnaire [RMQ]). Secondary outcomes were use of medication and self-reported health (mental and physical component summaries of the 12-Item Short-Form Health Survey [SF-12]). Separate linear mixed models for LBP, pain referred down the leg, and disability were developed to adjust for potential confounders. Randomization, outcome assessment, and data analyses were masked., Results: At 12 months, disability improved 0.7 (95% confidence interval [CI]=-0.4, 1.8) RMQ point in the control group, 1.5 (95% CI=0.4, 2.7) RMQ points in the GDS-I group, and 2.2 (95% CI=1.2, 3.2) RMQ points in the GDS-G group. There were no differences in pain., Limitations: The amount of exercise was smaller in the control group, and GDS-I sessions were provided by junior physical therapists., Conclusions: The improvement in disability was slightly higher with group GDS sessions than with the program routinely used in clusters within the SNHS. Adding individualized GDS sessions eliminated this advantage. Further studies should compare the GDS with other types of exercise., (© 2015 American Physical Therapy Association.)

Background: The presence of oligoclonal IgM bands (OCMB) in cerebrospinal fluid (CSF) is an unfavourable prognostic marker in multiple sclerosis. There is no commercial test to investigate OCMB status. However, a sensitive and specific isoelectrofocusing (IEF) and western blot method was described. We aimed to study the inter-centre reproducibility of this technique, a necessary condition for a reliable test to be incorporated into clinical practice., Methods: The presence of OCMB was analysed by IEF and western blot with prior reduction of pentameric IgM. We assayed the reproducibility of this test in a blinded multicentre study performed in 13 university hospitals. Paired-CSF and serum samples from 52 neurological patients were assayed at every centre., Results: Global analysis rendered a concordance of 89.8% with a kappa value of 0.71., Conclusion: These data indicate that OCMB detection by means of IEF and western blot with IgM reduction shows a good interlaboratory reproducibility and thus can be used in daily clinical setting., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: A major determinant of treatment offered to patients with non-small cell lung cancer (NSCLC) is their intrathoracic (mediastinal) nodal status. If the disease has not spread to the ipsilateral mediastinal nodes, subcarinal (N2) nodes, or both, and the patient is otherwise considered fit for surgery, resection is often the treatment of choice. Planning the optimal treatment is therefore critically dependent on accurate staging of the disease. PET-CT (positron emission tomography-computed tomography) is a non-invasive staging method of the mediastinum, which is increasingly available and used by lung cancer multidisciplinary teams. Although the non-invasive nature of PET-CT constitutes one of its major advantages, PET-CT may be suboptimal in detecting malignancy in normal-sized lymph nodes and in ruling out malignancy in patients with coexisting inflammatory or infectious diseases., Objectives: To determine the diagnostic accuracy of integrated PET-CT for mediastinal staging of patients with suspected or confirmed NSCLC that is potentially suitable for treatment with curative intent., Search Methods: We searched the following databases up to 30 April 2013: The Cochrane Library, MEDLINE via OvidSP (from 1946), Embase via OvidSP (from 1974), PreMEDLINE via OvidSP, OpenGrey, ProQuest Dissertations & Theses, and the trials register www.clinicaltrials.gov. There were no language or publication status restrictions on the search. We also contacted researchers in the field, checked reference lists, and conducted citation searches (with an end-date of 9 July 2013) of relevant studies., Selection Criteria: Prospective or retrospective cross-sectional studies that assessed the diagnostic accuracy of integrated PET-CT for diagnosing N2 disease in patients with suspected resectable NSCLC. The studies must have used pathology as the reference standard and reported participants as the unit of analysis., Data Collection and Analysis: Two authors independently extracted data pertaining to the study characteristics and the number of true and false positives and true and false negatives for the index test, and they independently assessed the quality of the included studies using QUADAS-2. We calculated sensitivity and specificity with 95% confidence intervals (CI) for each study and performed two main analyses based on the criteria for test positivity employed: Activity > background or SUVmax ≥ 2.5 (SUVmax = maximum standardised uptake value), where we fitted a summary receiver operating characteristic (ROC) curve using a hierarchical summary ROC (HSROC) model for each subset of studies. We identified the average operating point on the SROC curve and computed the average sensitivities and specificities. We checked for heterogeneity and examined the robustness of the meta-analyses through sensitivity analyses., Main Results: We included 45 studies, and based on the criteria for PET-CT positivity, we categorised the included studies into three groups: Activity > background (18 studies, N = 2823, prevalence of N2 and N3 nodes = 679/2328), SUVmax ≥ 2.5 (12 studies, N = 1656, prevalence of N2 and N3 nodes = 465/1656), and Other/mixed (15 studies, N = 1616, prevalence of N2 to N3 nodes = 400/1616). None of the studies reported (any) adverse events. Under-reporting generally hampered the quality assessment of the studies, and in 30/45 studies, the applicability of the study populations was of high or unclear concern.The summary sensitivity and specificity estimates for the 'Activity > background PET-CT positivity criterion were 77.4% (95% CI 65.3 to 86.1) and 90.1% (95% CI 85.3 to 93.5), respectively, but the accuracy estimates of these studies in ROC space showed a wide prediction region. This indicated high between-study heterogeneity and a relatively large 95% confidence region around the summary value of sensitivity and specificity, denoting a lack of precision. Sensitivity analyses suggested that the overall estimate of sensitivity was especially susceptible to selection bias; reference standard bias; clear definition of test positivity; and to a lesser extent, index test bias and commercial funding bias, with lower combined estimates of sensitivity observed for all the low 'Risk of bias' studies compared with the full analysis.The summary sensitivity and specificity estimates for the SUVmax ≥ 2.5 PET-CT positivity criterion were 81.3% (95% CI 70.2 to 88.9) and 79.4% (95% CI 70 to 86.5), respectively.In this group, the accuracy estimates of these studies in ROC space also showed a very wide prediction region. This indicated very high between-study heterogeneity, and there was a relatively large 95% confidence region around the summary value of sensitivity and specificity, denoting a clear lack of precision. Sensitivity analyses suggested that both overall accuracy estimates were marginally sensitive to flow and timing bias and commercial funding bias, which both lead to slightly lower estimates of sensitivity and specificity.Heterogeneity analyses showed that the accuracy estimates were significantly influenced by country of study origin, percentage of participants with adenocarcinoma, (¹⁸F)-2-fluoro-deoxy-D-glucose (FDG) dose, type of PET-CT scanner, and study size, but not by study design, consecutive recruitment, attenuation correction, year of publication, or tuberculosis incidence rate per 100,000 population., Authors' Conclusions: This review has shown that accuracy of PET-CT is insufficient to allow management based on PET-CT alone. The findings therefore support National Institute for Health and Care (formally 'clinical') Excellence (NICE) guidance on this topic, where PET-CT is used to guide clinicians in the next step: either a biopsy or where negative and nodes are small, directly to surgery. The apparent difference between the two main makes of PET-CT scanner is important and may influence the treatment decision in some circumstances. The differences in PET-CT accuracy estimates between scanner makes, NSCLC subtypes, FDG dose, and country of study origin, along with the general variability of results, suggest that all large centres should actively monitor their accuracy. This is so that they can make reliable decisions based on their own results and identify the populations in which PET-CT is of most use or potentially little value.

Background & Aims: Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer (CRC), but few studies have compared its efficacy for CRC detection with that of other screening strategies. We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests (FITs) and colonoscopy in detecting advanced neoplasia (advanced adenoma or CRC) in family members of patients with CRC., Methods: In a prospective study, 1918 first-degree relatives of patients with CRC were randomly assigned (1:1 ratio) to receive a single colonoscopy examination or 3 FITs (1/year for 3 years; OC-Sensor; cutoff ≥10 μg hemoglobin/g feces, corresponding to 50 ng hemoglobin/mL buffer). The strategies were considered to be equivalent if the 95% confidence interval of the difference for the detection of advanced neoplasia was ±3%. Follow-up analyses were performed to identify false-negative FIT results and interval CRCs., Results: Of all eligible asymptomatic first-degree relatives, 782 were included in the colonoscopy group and 784 in the FIT group. In the intention-to-screen analysis, advanced neoplasia was detected in 33 (4.2%) and 44 (5.6%) first-degree relatives in the FIT and colonoscopy groups, respectively (odds ratio = 1.41; 95% confidence interval: 0.88-2.26; P = .14). In the per-protocol analysis, 28 first-degree relatives (3.9%) in the FIT group and 43 (5.8%) in the colonoscopy group had advanced neoplasia (odds ratio = 1.56; 95% confidence interval: 0.95-2.56; P = .08). FIT missed 16 of 41 advanced adenomas but no CRCs. The FIT strategy required endoscopic evaluation of 4-fold fewer individuals to detect 1 advanced neoplasia than the colonoscopy strategy., Conclusions: Repeated FIT screening (1/year for 3 years) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC. This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy. ClinicalTrials.gov number: NCT01075633 (COLONFAM Study)., (Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background Context: In the context of shared decision-making, a valid estimation of the probability that a given patient will improve after a specific treatment is valuable., Purpose: To develop models that predict the improvement of spinal pain, referred pain, and disability in patients with subacute or chronic neck or low back pain undergoing a conservative treatment., Study Design and Setting: Analysis of data from a prospective registry in routine practice., Patient Sample: All patients who had been discharged after receiving a conservative treatment within the Spanish National Health Service (SNHS) (n=8,778)., Outcome Measures: Spinal pain, referred pain, and disability were assessed before the conservative treatment and at discharge by the use of previously validated methods., Methods: Improvement in spinal pain, referred pain, and disability was defined as a reduction in score greater than the minimal clinically important change. A predictive model that included demographic, clinical, and work-related variables was developed for each outcome using multivariate logistic regression. Missing data were addressed using multiple imputation. Discrimination and calibration were assessed for each model. The models were validated by bootstrap, and nomograms were developed., Results: The following variables showed a predictive value in the three models: baseline scores for pain and disability, pain duration, having undergone X-ray, having undergone spine surgery, and receiving financial assistance for neck or low back pain. Discrimination of the three models ranged from slight to moderate, and calibration was good., Conclusions: A registry in routine practice can be used to develop models that estimate the probability of improvement for each individual patient undergoing a specific form of treatment. Generalizing this approach to other treatments can be valuable for shared decision making., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: This paper examines the Willingness to Pay (WTP) for a quality-adjusted life year (QALY) expressed by people who attended the healthcare system as well as the association of attitude towards risk and other personal characteristics with their response., Methods: Health-state preferences, measured by EuroQol (EQ-5D-3L), were combined with WTP for recovering a perfect health state. WTP was assessed using close-ended, iterative bidding, contingent valuation method. Data on demographic and socioeconomic characteristics, as well as usage of health services by the subjects were collected. The attitude towards risk was evaluated by collecting risky behaviors data, by the subject's self-evaluation, and through lottery games., Results: Six hundred and sixty two subjects participated and 449 stated a utility inferior to 1. WTP/QALY ratios varied significantly when payments with personal money (mean €10,119; median €673) or through taxes (mean €28,187; median €915) were suggested. Family income, area income, higher education level, greater use of healthcare services, and the number of co-inhabitants were associated with greater WTP/QALY ratios. Age and female gender were associated with lower WTP/QALY ratios. Risk inclination was independently associated with a greater WTP/QALY when "out of pocket" payments were suggested. Clear discrepancies were demonstrated between linearity and neutrality towards risk assumptions and experimental results., Conclusions: WTP/QALY ratios vary noticeably based on demographic and socioeconomic characteristics of the subject, but also on their attitude towards risk. Knowing the expression of preferences by patients from this outcome measurement can be of interest for health service planning.