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.

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.

Five-year follow-up mortality prognostic index for colorectal patients.

PURPOSE: To identify 5-year survival prognostic variables in patients with colorectal cancer (CRC) and to propose a survival prognostic score that also takes into account changes over time in the patient's health-related quality of life (HRQoL) status. METHODS: Prospective observational cohort study of CRC patients. We collected data from their diagnosis, intervention, and at 1, 2, 3, and 5 years following the index intervention, also collecting 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. Multivariate Cox proportional models were used. RESULTS: We found predictors of mortality over the 5-year follow-up to be being older; being male; having a higher TNM stage; having a higher lymph node ratio; having a result of CRC surgery classified as R1 or R2; invasion of neighboring organs; having a higher score on the Charlson comorbidity index; having an ASA IV; and having worse scores, worse quality of life, on the EORTC and EQ-5D questionnaires, as compared to those with higher scores in each of those questionnaires respectively. CONCLUSIONS: These results allow preventive and controlling measures to be established on long-term follow-up of these patients, based on a few easily measurable variables. IMPLICATIONS FOR CANCER SURVIVORS: Patients with colorectal cancer should be monitored more closely depending on the severity of their disease and comorbidities as well as the perceived health-related quality of life, and preventive measures should be established to prevent adverse outcomes and therefore to ensure that better treatment is received. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02488161.

Reference values of EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L for women with non-metastatic breast cancer at diagnosis and 2 years after.

PURPOSE: To obtain reference norms of EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L, based on a population of Spanish non-metastatic breast cancer patients at diagnosis and 2 years after, according to relevant demographic and clinical characteristics. METHODS: Multicentric prospective cohort study including consecutive women aged ≥ 18 years with a diagnosis of incident non-metastatic breast cancer from April 2013 to May 2015. Health-related quality of life (HRQoL) questionnaires were administered between diagnosis and beginning the therapy, and 2 years after. HRQoL differences according to age, comorbidity and stage were tested with ANOVA or Chi Square test and multivariate linear regression models. RESULTS: 1276 patients were included, with a mean age of 58 years. Multivariate models of EORTC QLQ-C30 summary score and EQ-5D-5L index at diagnosis and at 2-year follow-up show the independent association of comorbidity and tumor stage with HRQoL. The standardized multivariate regression coefficient of EORTC QLQ-C30 summary score was lower (poorer HRQoL) for women with stage II and III than for those with stage 0 at diagnosis (- 0.11 and - 0.07, p < 0.05) and follow-up (- 0.15 and - 0.10, p < 0.01). The EQ-5D-5L index indicated poorer HRQoL for women with Charlson comorbidity index ≥ 2 than comorbidity 0 both at diagnosis (- 0.13, p < 0.001) and follow-up (- 0.18, p < 0.001). Therefore, we provided the reference norms at diagnosis and at the 2-year follow-up, stratified by age, comorbidity index, and tumor stage. CONCLUSION: These HRQoL reference norms can be useful to interpret the scores of women with non-metastatic breast cancer, comparing them with country-specific reference values for this population.

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.

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.

Factors that Influence Treatment Delay for Patients with Breast Cancer.

INTRODUCTION: The diagnosis or treatment of breast cancer is sometimes delayed. A lengthy delay may have a negative psychological impact on patients. The aim of our study was to evaluate the sociodemographic, clinical and pathological factors associated with delay in the provision of surgical treatment for localised breast cancer, in a prospective cohort of patients. METHODS: This observational, prospective, multicentre study was conducted in ten hospitals belonging to the Spanish national public health system, located in four Autonomous Communities (regions). The study included 1236 patients, diagnosed through a screening programme or found to be symptomatic, between April 2013 and May 2015. The study variables analysed included each patient's personal history, care situation, tumour history and data on the surgical intervention, pathological anatomy, hospital admission and follow-up. Treatment delay was defined as more than 30 days elapsed between biopsy and surgery. RESULTS: Over half of the study population experienced surgical treatment delay. This delay was greater for patients with no formal education and among widows, persons not requiring assistance for usual activities, those experiencing anxiety or depression, those who had a high BMI or an above-average number of comorbidities, those who were symptomatic, who did not receive NMR spectroscopy, who presented a histology other than infiltrating ductal carcinoma or who had poorly differentiated carcinomas. CONCLUSIONS: Certain sociodemographic and clinical variables are associated with surgical treatment delay. This study identifies factors that influence surgical delays, highlighting the importance of preventing these factors and of raising awareness among the population at risk and among health personnel.

Factors associated with colon cancer early, intermediate and late recurrence after surgery for stage I-III: A 5-year prospective study.

OBJECTIVE: To identify factors associated with early, intermediate or late recurrence colon cancer recurrence. METHODS: A total of 1,732 consecutive patients with colon cancer were recruited and followed for a period of 5 years. Recurrence at 1 year (early), from 1 to 2 (early), from 2 to 3 (intermediate) and from 3 to 5 years (late) was the main outcome measures. RESULTS: Predictors of early recurrence (AUC (95% CI):0.74 (0.70-0.78) were as follows: TNM stage II and III, more than one type of invasion, haemoglobin <10 g/dl, residual tumour (R1), ASA IV, log odds of positive lymph nodes ratio ≥-0.53, perforation, neoadjuvant chemotherapy, infectious complications within 1 year and CEA pre- and post-intervention. These factors remained significant for predicting intermediate (AUC [95% CI]: 0.72 [0.67-0.77]) and late (AUC [95% CI]: 0.68 [0.63-0.74]) recurrence, except for ASA class, log lymph node ratio, perforation and neoadjuvant chemotherapy. Additionally, laterality (left) and medical complications up to 2 years were significant. CONCLUSIONS: These risk factors show good predictive ability of early, intermediate and late recurrence, confirming factors established by guidelines and adding some others. They could serve to provide more appropriate and accurate treatment and follow-up tailored to patient characteristics.

Risk factors affecting hospital stay among patients undergoing colon cancer surgery: a prospective cohort study.

PURPOSE: To identify and validate risk factors that contribute to prolonged length of hospital stay (LOS) in patients undergoing resection for colorectal cancer. METHODS: This prospective cohort study included 1955 patients admitted to 22 hospitals for primary resection of colorectal cancer. Multivariate analyses were used to identify and validate risk factors, randomizing patients into a derivation and a validation cohort. Multiple correspondence and cluster analysis were performed to identify clinical subtypes based on LOS. RESULTS: The strongest independent predictors of prolonged LOS were postoperative reintervention, surgical site infection, open surgery, and distant metastasis. The multiple correspondence and cluster analysis provided three groups of patients in relation to prolonged LOS: patients with the longest LOS included the highest percentage of patients with open surgery, distant metastasis, deep surgical site infections, emergency admissions, additional diagnostic factors, and highly contaminated surgical sites. Patients with prolonged LOS (> 14 days) were more likely to develop adverse outcomes within 30 days after discharge. CONCLUSIONS: Patients undergoing resection of colorectal cancer cluster into different groups based on LOS of the index admission. Those with prolonged LOS were more likely to develop adverse outcomes within 30 days after discharge. Some of the strongest independent predictors of prolonged LOS, such as surgical infections or open surgery, could be modified to reduce LOS and, in turn, other adverse outcomes. TRIAL REGISTRATION: NCT02488161.

Author’s reply: "A question on dyspeptic patients analyzed by psychometric scores"

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Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

BACKGROUND: Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. METHODS: Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. DATA COLLECTION: Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. STATISTICAL ANALYSIS: Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. DISCUSSION: The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications. TRIAL REGISTRATION: NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .

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 (AU)

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Psychometric characteristics of the Spanish version of the Barthel Index.

BACKGROUND: The Barthel Index is one of the most employed questionnaires for the evaluation of functionality, but there is no information on its psychometric properties. OBJECTIVE: The aim was to evaluate the reliability, validity, and responsiveness of the Spanish version of the Barthel Index. METHODS: The data employed in this paper were obtained from four Spanish cohorts of elderly people of 60 years or older. We collected data on age, gender, education level, comorbidities, and questionnaires regarding functionality, health-related quality of life, depression, and social support. RESULTS: The Cronbach's alpha coefficients were greater than 0.70. The confirmatory factor analysis provided satisfactory fit indexes and factor loadings. The correlation coefficients between the Barthel Index and the other questionnaires were lower than the Cronbach's alpha coefficients. Known-groups validity showed significant differences in the Barthel Index according to age, number of comorbidities, and gender. The standardized effect size and the standardized response mean were between 0.68 and 1.81. DISCUSSION: This version of the Barthel Index has good reliability, its structural validity has been confirmed, and the questionnaire can discriminate between groups and detect changes at follow-up points. CONCLUSIONS: This questionnaire can be used in the evaluation of functionality and basic activities of daily living in elderly people with different conditions.

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.

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.

Wrist fractures and their impact in daily living functionality on elderly people: a prospective cohort study.

BACKGROUND: Wrist fractures are the most common arm fractures in older adults. The impact of wrist fractures on daily functionality has been less studied than that of other types and so, less is known about the complexity of factors related to the functional impact of these fractures. This study is aimed to assess the role of individual and health care factors and its association with daily living functional changes after a wrist fracture. METHODS: A prospective cohort of patients aged 65 or more, affected by a fracture due to a fall, was conducted. These patients were identified at the emergency rooms of the six participating hospitals. As independent factors, the following were studied: socio-demographic data, characteristics of the fracture, health-related quality of life, wrist function and provided treatment. The main outcome was functional status measured by the Barthel Index for daily living basic activities and the Lawton Instrumental Activities of Daily Living (IADL) Scale for daily living instrumental activities. Data were collected at baseline just after the fall and after six months of follow-up. Patients were considered to have deteriorated if their functional status as measured by Barthel Index or Lawton IADL scores decreased in a significant way during the six months of follow up. RESULTS: Barthel Index and/or Lawton IADL scores fell at six months after the fracture in 33% of participants. This functional decline was more frequent in patients with comorbidity (p < 0.0001), polypharmacy (p < 0.0001), low health-related quality of life prior to the fall (p < 0.0001) and lower educational level (p = 0.009). The derived multivariate models show that patients that become dependent six months after the fall, have advanced age, severe chronic diseases, low functional performance prior to the fracture, and repeated episodes of accidental falls. This profile is consistent with a frailty phenotype. CONCLUSIONS: Wrist fractures are associated to the occurrence of dependence, especially in frail patients. These patients could benefit from being identified at the time the fracture is treated, in order to tackle their complex needs and so, prevent some of the burden of dependence generated by these fractures.