Anxiety, depression, health-related quality of life, and mortality among colorectal patients: 5-year follow-up.

PURPOSE: Health-related quality of life (HRQoL) measurement represents an important outcome in cancer patients. We describe the evolution of HRQoL over a 5-year period in colorectal cancer patients, identifying predictors of change and how they relate to mortality. METHODS: Prospective observational cohort study including colorectal cancer (CRC) patients having undergone surgery in nineteen public hospitals who were monitored from their diagnosis, intervention and at 1-, 2-, 3-, and 5-year periods thereafter by gathering HRQoL data using the EuroQol-5D-5L (EQ-5D-5L), European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) questionnaires. Multivariable generalized linear mixed models were used. RESULTS: Predictors of Euroqol-5D-5L (EQ-5D-5L) changes were having worse baseline HRQoL; being female; higher Charlson index score (more comorbidities); complications during admission and 1 month after surgery; having a stoma after surgery; and needing or being in receipt of social support at baseline. For EORTC-QLQ-C30, predictors of changes were worse baseline EORTC-QLQ-C30 score; being female; higher Charlson score; complications during admission and 1 month after admission; receiving adjuvant chemotherapy; and having a family history of CRC. Predictors of changes in HADS anxiety were being female and having received adjuvant chemotherapy. Greater depression was associated with greater baseline depression; being female; higher Charlson score; having complications 1 month after intervention; and having a stoma. A deterioration in all HRQoL questionnaires in the previous year was related to death in the following year. CONCLUSIONS: These findings should enable preventive follow-up programs to be established for such patients in order to reduce their psychological distress and improve their HRQoL to as great an extent as possible. GOV IDENTIFIER: NCT02488161.

Effect of comorbidities on long-term outcomes of colorectal cancer patients.

OBJECTIVE: The objective of this work is to evaluate the association of comorbidities with various outcomes in patients diagnosed with colon or rectal cancer. METHODS: We conducted a prospective cohort study of patients diagnosed with colon or rectal cancer who underwent surgery. Data were gathered on sociodemographic, clinical characteristics, disease course, and the EuroQol EQ-5D and EORTC QLQ-C30 scores, up to 5 years after surgery. The main outcomes of the study were mortality, complications, readmissions, reoperations, and changes in PROMs up to 5 years. Multivariable multilevel logistic regression models were used in the analyses. RESULTS: Mortality at some point during the 5-year follow-up was related to cardiocerebrovascular, hemiplegia and/or stroke, chronic obstructive pulmonary disease (COPD), diabetes, cancer, and dementia. Similarly, complications were related to cardiovascular disease, COPD, diabetes, hepatitis, hepatic or renal pathologies, and dementia; readmissions to cardiovascular disease, COPD, and hepatic pathologies; and reoperations to cerebrovascular and diabetes. Finally, changes in EQ-5D scores at some point during follow-up were related to cardiocerebrovascular disease, COPD, diabetes, pre-existing cancer, hepatic and gastrointestinal pathologies, and changes in EORTC QLQ-C30 scores to cardiovascular disease, COPD, diabetes, and hepatic and gastrointestinal pathologies. CONCLUSIONS: Optimising the management of the comorbidities most strongly related to adverse outcomes may help to reduce those events in these patients.

Predictors of readmission and reoperation in patients with colorectal cancer.

PURPOSE: To assess the impact of readmission and reoperation on colon or rectal cancer patients in clinical and patient-reported outcome measures (PROMs) and to identify predictors of these events up to 1 year after surgery. METHODS: Prospective cohort study of patients diagnosed with colon or rectal cancer who underwent surgery at 1 of 22 hospitals. Medical history, clinical parameters, and PROMs were evaluated as possible predictors. Multivariable multilevel logistic regression and survival models were used in the analyses to create the clinical prediction rules. Models were developed in a derivation sample and validated in a different sample. RESULTS: Readmission and reoperation were related to clinical outcomes and changes in some PROMs. Predictors of readmission in colon cancer were ASA class (odds ratio (OR) 4.5), TNM (OR for TNM III 3.24, TNM IV 4.55), evidence of residual tumor (R2) (OR 3.96), and medical (OR 1.96) and infectious (OR 2.01) complications within 30 days after surgery, while for rectal cancer, the predictors identified were age (OR 1.03), R2 (OR 6.48), infectious complications within 30 days (OR 2.29), hemoglobin (OR 3.26), lymph node ratio (OR 2.35), and surgical complications within 1 month (OR 3.04). Predictors of reoperation were TNM IV (OR 5.06), surgical complications within 30 days (OR 1.98), and type and site of tumor (OR 1.72) in colon cancer and being male (OR 1.52), age (OR 1.80), stoma (OR 1.87), and surgical complications within 1 month (OR 1.95) in rectal cancer. CONCLUSIONS: Our clinical prediction rule models are easy to use and could help to develop and implement interventions to reduce preventable readmissions and reoperations. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02488161 Identifier: NCT02488161.

Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer.

BACKGROUND: It has been argued that laparoscopy should be a standard treatment in rectal cancer due to its greater technical complexity. The objective of this study was to conduct a cost-effectiveness analysis to compare laparoscopy with open surgery for rectal cancer adjusting for age and clinical stage. METHODS: A real-world prospective cost-effectiveness cohort study was conducted with data on costs and effectiveness at individual patient level. A "genetic matching" algorithm was used to correct for selection bias. After balancing the sample groups, combined multivariate analysis of total costs and quality-adjusted life years (QALYs) was performed using seemingly unrelated regression (SUR) models. These models were first constructed without interactions and, subsequently, effects of any age-stage interaction were analyzed. RESULTS: The sample included 601 patients (400 by laparoscopy and 201 by open surgery). Crude cost-effectiveness analysis indicated that overall laparoscopy was cheaper and associated with higher QALYs. The SUR models without interactions showed that while laparoscopy remained dominant, the incremental effectiveness decreased to the point that it offered no statistically significant benefits over open surgery. In the subgroup analysis, at advanced stages of the disease, although none of the coefficients were significant, the mean incremental effectiveness (QALYs value) for laparoscopy was positive in younger patients and negative in older patients. Further, for advanced stages, the mean cost of open surgery was lower in both age subgroups but differences did not reach statistical significance. In early stages, laparoscopy cost was significantly lower in the subgroup younger than 70 and higher in the older subgroup. CONCLUSIONS: The cost-effectiveness of laparoscopy in surgery for rectal cancer justifies this being the standard surgical procedure in young patients and those at initial stages. The choice of procedure should be discussed with patients who are older and/or in advanced stages of the disease. Trial registration ClinicalTrials.gov Identifier: NCT02488161.

Predictors of mortality during hospitalization and 3 months after discharge in elderly people with and without dementia.

Objectives: The aims of this study were to assess mortality during hospitalization and 3 months after discharge in elderly people with and without dementia, and to identify variables that might predict mortality. Methods: A prospective matched cohort study was conducted involving 195 inpatients with dementia and 204 inpatients without dementia. Information on sociodemographic, and clinical data were gathered. Patients completed questionnaires on premorbid basic (Barthel, BI) and instrumental activities of daily living (Lawton and Brody), quality of life (EuroQoL5-D; Quality of Life in Alzheimer's Disease), burden of the caregiver (Zarit). Data were collected on admission and 3 months after discharge. Descriptive analyses, univariable analyses and multivariable logistic regression models were applied to identify risk factors associated with mortality at 90 days. Results: For patients with dementia the following variables were predictors of mortality: having complications during admission, age >84 years, myocardial infarction, >145 sodium and lower BI. For patients without dementia, having lower BI, adverse events during hospitalization, older patient age, sodium >145, no surgery during admission, and more than 2 classes of medication at admission were predictors of mortality. Conclusion: Adequate nutritional support should be initiated to optimize the clinical outcome of these patients.

Outcomes of open versus laparoscopic surgery in patients with rectal cancer.

PURPOSE: The goal of this study was to compare the effectiveness of laparoscopic with that of open surgery up to 2 years after intervention in patients with rectal cancer. METHODS: This is a prospective cohort study of patients with rectal cancer who underwent surgery (laparoscopic or open) between June 2010 and December 2012 in 22 acute hospitals. Main outcomes were mortality, complications, reoperation, readmission, and patient-reported outcome measures (PROMs), as measured using the EuroQol-5D (EQ-5D), European Organisation for Research and Treatment of Cancer (EORTC) QLQ-Q30 and Q29, the Barthel Index (BI), and the Duke-UNC Functional Social Support Questionnaire at baseline, 1 year, and 2 years after surgery. Multivariable multilevel logistic regression and generalized linear models were used in the analyses after adjusting for specific propensity scores developed for each outcome and time point. RESULTS: In the multivariable analysis, rates of some medical complications after surgery during admission (renal failure and paralytic ileus) and infectious (urinary tract infection, septic shock, and localized intra-abdominal infection) and at 1 year (renal and heart failure) were higher among patients who underwent open surgery than among those who underwent laparoscopic surgery. There were no differences between the two surgical approaches in all other parameters assessed at the different time points or in all PROMs evaluated. CONCLUSIONS: Laparoscopic surgery and open surgery provide quite similar results in patients with rectal cancer up to 2 years after intervention in most outcomes, though the rates of certain medical and infectious complications at admission and up to 1 year after the intervention were higher in open surgery.

Cost-effectiveness analysis of laparoscopic versus open surgery in colon cancer.

BACKGROUND: Few economic evaluations have assessed laparoscopy for colon cancer. This study aimed to compare the cost-effectiveness of laparoscopic and open surgery for the treatment of colon cancer. METHOD: A cost-effectiveness analysis was performed comparing two groups of patients treated according to standard clinical practice (REDISSEC-CARESS/CCR cohort) by laparoscopic or open surgery. Data were collected from health records on clinical characteristics and resource use over 2 years after surgery. To calculate the incremental cost-effectiveness ratio, costs and quality-adjusted life years (QALYs) were obtained for each patient. Clinical heterogeneity was addressed using propensity score and joint multivariable analysis (seemingly unrelated regression) that included interactions between TNM stage, age, and surgical procedure to perform subgroup analysis. RESULTS: The sample was composed of 1591 patients, 963 who underwent laparoscopy and 628 open surgery. Using propensity score and regression analysis, we found that laparoscopy was associated with more QALYs and less resource use than open surgery (0.0163 QALYs, 95% CI 0.0114-0.0212; and - €3461, 95% CI - 3337 to - 3586). Costs were lower for laparoscopy in all subgroups. In the subgroups younger than 80 years old, utility was higher in patients who underwent laparoscopy. Nevertheless, open surgery had better outcomes in older patients in stages I-II (0.0618 QALYs) and IV (0.5090 QALYs). CONCLUSION: Overall, laparoscopy appears to be dominant, resulting in more QALYs and lower costs. Nevertheless, while laparoscopy required fewer resources in all subgroups, outcomes may be negatively affected in elderly patients, representing an opportunity for shared decision making between surgeons and patients. ClinicalTrials.gov Identifier: NCT02488161.

New psychometric data from the Spanish versions of the Glasgow Dyspepsia Severity Score and the Dyspepsia-Related Health Scale measures.

BACKGROUND AND OBJECTIVE: There are no structural abnormalities in functional dyspepsia, therefore it is essential to have a viable questionnaire to measure treatment outcome according to patient perception. The aim of the study was to extensively document psychometric characteristics of the Glasgow Dyspepsia Severity Score and the Dyspepsia-Related Health Scale that are currently available in Spanish. METHODS: Patients with functional dyspepsia (n = 158) were recruited from a randomized trial that assessed standard vs. standard and psychological treatment. Participants had completed the validation questionnaires and the Medical Outcome Study Short-form 36. Reliability (Cronbach's alpha), validity (Confirmatory Factor Analysis, convergent and known group validity) and responsiveness (minimal clinically important difference) were analyzed. RESULTS: A Confirmatory Factor Analysis of the Glasgow Dyspepsia Severity Score showed a one-factor solution model, but a low Cronbach's alpha (0.61). With regard to the Dyspepsia-Related Health Scale, the Cronbach's alpha (0.80-0.97) and Confirmatory Factor Analysis supported a model with four inter-correlated dimensions and suggested a need to improve the "Satisfaction with dyspepsia-related health" dimension (Cronbach's alpha < 20). Finally, the global scores for both the Glasgow Dyspepsia Severity Score and the Dyspepsia-Related Health Scale were responsive at six months post-treatment, with a minimal clinically important difference of 4 and 6, respectively. CONCLUSIONS: Our findings support the continued application of the Dyspepsia-Related Health Scale and the need to improve the "Satisfaction with dyspepsia-related health" dimension. Although the Glasgow Dyspepsia Severity Score is a promising questionnaire, further review of the content is required to eliminate and add items in order to provide greater consistency to the evaluated construct.

Clinical Outcome of Mechanical Thrombectomy for Stroke in the Elderly.

BACKGROUND: Endovascular revascularization with mechanical devices has proven an effective treatment for proximal occlusions of the major intracranial arteries in stroke patients, but there is only limited information as to whether there should be an age limit for its use. We aimed to evaluate the safety and effectiveness of endovascular revascularization in stroke patients aged 80 years and older, and compare the results with younger patients. METHODS: We prospectively collected 81 consecutive patients subjected to mechanical thrombectomy for proximal occlusion of the anterior circulation during a period of 27 months. According to age, patients were divided into those aged less than 80 years (younger group) and those aged 80 years and older (elderly group). We analyzed favorable outcome, successful and futile recanalization, neurological improvement, in-hospital complications, and mortality in both groups. RESULTS: A favorable outcome (modified Rankin Scale score ≤2 at 3 months) was reached by 51.6% in the elderly group and 64% of younger patients, and neurological improvement (improvement of ≥4 points on National Institutes of Health Stroke Scale) was present in 77.4% of the elderly group. Overall, successful recanalization rates were 95.1% and futile recanalization reached 39% without statistically significant differences between both groups. Elderly patients presented more in-hospital complications (61.3% versus 38%) and higher mortality rates (16.1% versus 8%). CONCLUSIONS: Clinical independence was reached in over half of elderly stroke patients treated with mechanical thrombectomy, supporting the use of this treatment without age restriction.

Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project.

BACKGROUND: Colorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients. DESIGN: a prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention. STATISTICAL ANALYSIS: In relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models. DISCUSSION: The identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this large cohort of patients may provide useful information to answer different health services research questions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02488161 . Registration date: June 16, 2015.

Factors related to a decline in upper extremity function among patients with a wrist fracture due to a fall.

AIMS: The aim of this study was to identify factors related to a decline in function following a wrist fracture. METHODS: Observational, prospective cohort study done in five public hospitals of the Basque Health Service. We recruited adults aged 65 or older with a wrist fracture due to a fall who attended the emergency department (ED) of one of these hospitals. Sociodemographic and clinical data were collected, along with information about health-related quality of life (HRQoL) and functionality. RESULTS: A decline in function 6 months after the fracture was more likely among women (OR=3.409; 95% CI=1.920-6.053), patients receiving institutional help before the fracture (OR=5.717; 95% CI=1.644-19.883), patients who developed fracture-related complications within 6 months of the fall (OR=5.015; 95% CI=1.377-18.268), patients who visited an ED within 6 months of the fall (OR=1.646; 95% CI=1.058-2.561), patients with a displaced fracture (OR=1.595; 95% CI=1.106-2.300), and patients who broke the dominant hand (OR=1.464; 95% CI=1.019-2.103). Better baseline HRQoL and function were associated with smaller declines in function 6 months after the fall. Eighteen months after the fall, decline in function was more likely among women (OR=2.172; 95% CI=1.138-4.144) and patients visiting an ED because of fracture-related complications (OR=1.722; 95% CI=1.113-2.663). Better HRQoL and dependency level at baseline were associated with less decline in function 18 months after the fracture. DISCUSSION: Two different models identified several parameters related to declines in upper extremity function 6 and 18 months after the fracture. CONCLUSIONS: These results can help develop preventive actions needed to avoid or reduce the consequences of these falls.

One-year Mortality in COPD After an Exacerbation: The Effect of Physical Activity Changes During the Event.

Mortality is one of the most important outcomes in patients with chronic obstructive pulmonary disease (COPD). Different predictors have been associated with mortality, including the patient's level of physical activity (PA). The objective of this work was to establish the relationship between changes in PA during a moderate-to-severe COPD exacerbation (eCOPD) and 1-year mortality after the index event. This was a prospective observational cohort study with recruitment of 2,484 patients with an eCOPD attending the emergency department (ED) of 16 participating hospitals. Variables recorded included clinical and sociodemographic data from medical records, dyspnea, health-related quality of life, and PA before the index eCOPD and 2 months after the hospital or ED discharge, as reported by the patient. In the multivariate analysis worsening changes in PA from baseline to 2 months after the ED index visit [odds ratio (ORs) from 2.78 to 6.31] was related to 1-year mortality, using the age-adjusted Charlson comorbidity index (OR: 1.22), and previous use of long-term domiciliary oxygen therapy or non-invasive mechanical ventilation at home (OR: 1.68). The same variables were also predictive in the validation sample. Areas under the receiver operating characteristic curve in the derivation and validation sample were 0.79 and 0.78, respectively. In conclusion, PA is the strongest predictor of dying in the following year, i.e., those with worsened PA from baseline to 2 months after an eCOPD or with very low PA levels have a higher risk.

Low cognitive reserve is associated with chronic migraine with medication overuse and poor quality of life.

OBJECTIVE: The objective of this article is to test the hypothesis that cognitive reserve (CR) is related to migraine chronification, medication overuse and poor quality of life in migraineurs. DESIGN/METHODS: A cross-sectional study on patients with chronic migraine with medication overuse (CM-MOH), episodic migraine (EM), and controls, matched by sex, age and education, was carried out. CR was assessed by a specific questionnaire, and quality of life was measured by general and specific questionnaires (SF-36 and MSQoL). Migraine Disability Assessment Scale and Beck questionnaires for depression and anxiety were used. Medication dependence was evaluated by the medication-dependence questionnaire in headache (MDQ-H). RESULTS: Fifty-five individuals were enrolled: 18 CM-MOH patients (32.73%), 22 EM patients (40%) and 15 controls (27.27%). Fifty (90.91%) of them were females and aged 43.53 (7.54) years.Univariate analysis showed a significant association between the study group and CR, and all items of the SF-36, anxiety and depression questionnaires, MSQoL and MDQ-H. The lower CR and CM-MOH group were related to a worse quality of life, more anxiety and depression and the highest medication dependence scores.Multivariate analysis showed that higher CR scores were related to higher quality of life as measured by the physical and mental composite scores of the SF-36, and to lower anxiety (beta = -1.08, p = 0.001) and depression (beta = -0.56, p = 0.03) levels. Focusing on MSQoL, the increase in CR was predictive of a better quality of life (beta = 1.88, p < 0.0001). By all the models, the explained variance of the sample ranged from 39% (mental composite score) to 58% (MSQoL). CONCLUSIONS: Low CR appears to be an independent factor associated with the deterioration of quality of life, the presence of anxiety and depression, and drug dependence and medication overuse in CM-MOH.

Right fronto-insular white matter tracts link cognitive reserve and pain in migraine patients.

BACKGROUND: Structural white matter abnormalities in pain-modulating, regions are present in migraine. Whether they are associated with pain chronification and with cognitive reserve is unclear. METHODS: Prospective, cohort, six-month study of adult patients with episodic or chronic migraine, and controls. Cognitive reserve, quality of life, impact of pain on daily living, depression and anxiety were assessed. Participants underwent a diffusion-tensor MRI to establish the integrity of white matter tracts of three regions of interest (ROIs) implicated in pain modulation, emotion, cognition and resilience (anterior insula, anterior cingulate gyrus, and uncinate fasciculus). RESULTS: Fifty-two individuals were enrolled: 19 episodic migraine patients, 18 chronic migraine patients, and 15 controls. The analysis of the fractional anisotropy in the ROIs showed that those patients with the poorest prognosis (i.e., those with chronic migraine despite therapy at six months--long-term chronic migraneurs) had a significantly lower fractional anisotropy in the right ROIs. Participants with higher cognitive reserve also had greater fractional anisotropy in the right anterior insula and both cingulate gyri. Multivariate analysis showed a significant association between cognitive reserve, migraine frequency, and fractional anisotropy in the right-sided regions of interest. CONCLUSIONS: Long-term chronic migraine patients show abnormalities in anterior white matter tracts, particularly of the right hemisphere, involved in pain modulation emotion, cognition and resilience. Robustness in these areas is associated with a higher cognitive reserve, which in turn might result in a lower tendency to migraine chronification.

Variables related to health-related quality of life among breast cancer survivors after participation in an interdisciplinary treatment combining mindfulness and physiotherapy.

BACKGROUND: Breast cancer diagnosis and treatment increase the potential psychological impact on breast cancer survivors (BCS). The objective of this study was to assess the effects of an interdisciplinary intervention during follow-up in BCS and identify variables related to improvements in HRQoL. MATERIALS AND METHODS: In a non-randomised quasi-experimental design performed on an outpatient basis in a hospital gynaecology and oncology unit, 60 BCS were assigned to an interdisciplinary experimental group (EG) or a usual care group (CG). The EG underwent 12 sessions of an interdisciplinary program which included Mindfulness and physiotherapy, for 120 min per day, once a week for 6 weeks. At baseline, at 6 weeks and at 3 months after the intervention, participants of EG and CG completed an assessment of HRQoL (EuroQol and EORTC-QLQ-C30) and symptomatology of anxiety and depression. Additionally, EG completed an assessment of satisfaction with the treatment. For data analysis, we used descriptive statistics, Wilcoxon test, Kruskal-Wallis test, Chi-square and Fisher tests and generalised linear models. RESULTS: After 6 weeks, statistically significant differences were apparent in global and cancer-related health symptoms such as fatigue and pain in the EORTC QLQ-C30 and in anxiety and depression, among the EG (n = 30) compared with the CG (n = 30). Patients receiving the intervention reported a high degree of satisfaction with the treatment. Three months after the intervention, patients in the EG continued to show statistically significant improvements compared with the CG. In addition, allocation to the EG was identified as a variable related to improvement of HRQoL (EORTC QLQ-C30) in the multivariable model. CONCLUSIONS: The results of our study suggest that a 6-week interdisciplinary intervention may improve HRQoL and symptomatology of anxiety and depression in BCS patients at 3 months. The study presents data that the intervention for BCS appears promising and warrants further study in a randomised controlled trial.

Physical activity and sedentary behaviour in patients admitted with COPD: Associated factors.

AIM: To establish amongst a cohort of patients admitted with Chronic Obstructive Pulmonary Disease which factors were associated with their level of Physical Activity and Sedentary Behavior prior to the admission event. METHODS: Prospective observational cohort study. Nine Spanish hospitals participated. Patients were recruited consecutively. Variables relating to the patients' clinical baseline status were recorded, including the COPD Assessment test, the HADS anxiety-depression test, comorbidities and the Yale Physical Activity Survey. Data relating to admission and up to two months after discharge were also recorded. RESULTS: 1638 COPD patients were studied, with a mean age of 72.39 (SD 10.33), 76.56 % male, FEV1 49.41 % (SD19.19), Charlson index 2. The level of PA at baseline was 30.79 points (SD 22.43). Multivariable linear regression analysis identified the following as being associated with low PA: older age, obesity, higher level of hemoglobin, lower score of Barthel index, which means disability, health related quality of life (EuroQoL-5d and CAT) and dyspnea. Variables associated with sedentary behavior were: older age, presence of obstructive apnea syndrome, higher disability, presence of depressive symptoms and dyspnea. CONCLUSIONS: In a cohort of hospitalized COPD patients, we have found several variables, some of them modifiable, associated with physical activity/inactivity and sedentary behavior.

Quality Indicators and Outcomes in a Prospective Cohort of Colorectal Cancer Patients.

BACKGROUND: Some quality indicators of proper health care in patients with colorectal cancer have been established. AIMS: Our goal was to evaluate the relationship between performing of certain procedures or treatments, included as quality indicators, and some outcomes of indicators in the follow-up of colorectal cancer patients. METHODS: This was a prospective cohort study of patients diagnosed with colorectal cancer that underwent surgery and were followed at 1, 2, 3, and 5 years. CT scanning, colonoscopy, chemotherapy, and radiotherapy were evaluated in relation to various clinical outcomes and PROM changes over 5 years. Multivariable generalized linear mixed models were used to evaluate their effect on mortality, complications, recurrence, and PROM changes (HAD, EQ-5D, EORTC-Q30) at the next follow-up. RESULTS: CT scanning or colonoscopy was related to a decrease in the risk of dying, while chemotherapy at a specified moment was related to an increased risk. In the case of recurrence, CT scanning and chemotherapy showed statistically increased the risk, while all the procedures and treatments influenced complications. Regarding PROM scales, CT scanning, colonoscopy, and radiotherapy showed statistically significant results with respect to an increase in anxiety and decrease in quality of life measured by the EORTC. However, undergoing radiotherapy at a specified moment increased depression levels, and overall, receiving radiotherapy decreased the quality of life of the patients, as measured by the EuroQol-5d. CONCLUSIONS: After adjustment for sociodemographic factors, comorbidities, and severity of the disease, performing certain quality indicators of proper health care in patients with colorectal cancer was related to less mortality but higher adverse outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02488161.

Change in physical activity related to admission for exacerbation in COPD patients.

INTRODUCTION: The aim of this study was to determine the impact of hospitalizations on levels of physical activity (PA) and whether other factors were associated with subsequent changes in PA. METHODS: Prospective observational cohort study with a nested case-control study, with follow-up 60 days from the index hospital admission. Nine hospitals participated in the study. Patients were recruited consecutively. Several variables and questionnaires of the clinical baseline status of the patients were recorded including: the COPD Assessment Test (CAT), the Hospital Anxiety-Depression scale (HADS), comorbidities and the Yale Physical Activity Survey. Patients' data related to admission and up to two months after discharge were also recorded. RESULTS: 883 patients were studied: 79.7% male; FEV1 48%; Charlson index 2; 28.7% active smokers. The baseline PA level for the total sample was 23 points. A statistically significant difference in PA was found between patients readmitted up to 2 months after the index admission and those not readmitted (17vs. 27, p < 0.0001). Multivariable linear regression analysis identified the following as predictors of the decrease of PA from baseline (index admission) up to 2 months follow-up: admission for COPD exacerbation in the two months prior to the index admission; readmission up to 2 months after the index admission; baseline HAD depressive symptoms, worse CAT score, and patient-reported "need for help". CONCLUSIONS: In a cohort of admitted COPD patients, we identified a strong relationship between hospitalization for exacerbation and PA. In addition, some other potentially modifiable factors were found associated with the change in PA level after an admission.

Predictors of short-term COPD readmission.

COPD readmissions have a great impact on patients' quality of life and mortality. Our goal was to identify factors related to 60-day readmission. We conducted a prospective observational cohort study with a nested case-control study, with 60 days of follow-up after the index admission. Patients readmitted were matched, by age, baseline forced expiratory volume in 1 s and month at admission, with patients admitted in the same period but not readmitted at 2 months. Data were collected on sociodemographic and clinical characteristics and health-related quality of life data at the index admission and events from discharge to readmission within 60 days. Conditional logistic (60-day readmission) and Cox (days to readmission) regression models were constructed. Both multivariable analyses identified the following as predictors: any admission in the preceding 2 months (OR: 2.366; HR: 1.918), hematocrit at ED arrival ≤ 35% (OR: 2.949; HR: 1.570), pre-existing cardiovascular disease (valvular disease or myocardial infarction) (OR: 1.878; HR: 1.490); NIMV at discharge (OR: 0.547; HR: 0.70); no appointment with a specialist after discharge (OR: 5.785; HR: 3.373) and patient-reported need for help at home (OR: 2.978; HR: 2.061). The AUC for the logistic model was 0.845 and the c-index for the Cox model was 0.707. EuroQol EQ-5D score before the admission was correlated with a lower risk of readmission (OR: 0.383; HR: 0.670). As conclusions, we have identified factors related to 60-day readmission and summarized the findings in easy-to-use scoring scales that could be incorporated into the daily clinical routine and may help establish preventive measures to reduce future readmissions.Registration: Clinical Trial Registration NCT03227211.

Complications and diagnostic accuracy of CT-guided 18G tru-cut versus end-cut percutaneous core needle biopsy of solitary solid lung nodules.

PURPOSE: Percutaneous biopsy has demonstrated high accuracy in diagnosis of lung nodules, but the technique is not innocuous and a yield decrease in lesions smaller than 20 mm has been reported. We carried out a prospective study to evaluate and compare the complications and efficacy of percutaneous core needle biopsy (CNB) of solitary solid lung nodules, which were performed with two types of automatic guns. METHODS: 330 consecutive CT-guided CNB were included. Tru-cut or end-cut 18G devices were used alternatively. Nodules were categorized by their size: ≤10 mm, 11-20 mm and >20 mm. Incidence of complications such as pneumothorax or hemoptysis and factors influencing them (nodule size and depth within lung parenchyma) were evaluated. Diagnostic accuracy of CNB achieved in the three groups of nodules regarding the two different needles were calculated and statistically evaluated and compared. RESULTS: We performed 68 CNB in nodules ≤10 mm, 130 in 11-20 mm and 132 in >20 mm. Pneumothorax appeared in 24.2% of them, but only 5.7% required drainage. Hemoptysis was developed in 9.4% and abundant hemoptysis with hypoxemia was observed in only 4.2% of patients. Regarding appearance of complications between the two needle types, no significant differences were found. A higher risk of hemoptysis was observed in nodules ≤10 mm (OR = 3.87; 95% CI = 1.24-12.06, P = 0.019) and in those located deeper in pulmonary parenchyma (OR = 2.21; 95% CI = 1.04-4.69, P = 0.038). End-cut needles reached a diagnostic accuracy of 93.7%, 92.1% and 98.3%, in nodules sized ≤10 mm, 11-20 mm and >20 mm, respectively. Corresponding results for tru-cut were 84.7%, 88.5% and 92.1%. In spite of differences reaching up to 9% in smaller nodules, intra-group results were not significant. CONCLUSION: Both needles have similar complications rate. Despite not having observed statistically significant differences between the two types of needles, end-cut devices have demonstrated a higher diagnostic yield in the three groups of nodules and could be a more suitable option especially for CNB of nodules ≤10 mm.