Psychosis and substance abuse increase the COVID-19 mortality risk.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has been a global challenge. High mortality rates have been reported in some risk groups, including patients with pre-existing mental disorders. METHODS: We used electronic health records to retrospectively identify people infected due to COVID-19 (between March 2020 and March 2021) in the three territories of the Basque Country. COVID-19 cases were defined as individuals who had tested positive on a reverse transcription-polymerase chain reaction (PCR) test. Univariate and multivariate logistic regression models and multilevel analyses with generalized estimated equations were used to determine factors associated with COVID-19-related mortality and hospital admission. RESULTS: The COVID-19 mortality rate was increased for patients with psychotic disorders [odds ratio (OR) adjusted: 1.45, 95% confidence interval (CI) (1.09-1.94), p = 0.0114] and patients with substance abuse [OR adjusted: 1.88, 95% CI (1.13-3.14, p < 0.0152)]. The mortality rate was lower for patients with affective disorders [OR adjusted: 0.80, 95% CI (0.61-0.99), p = 0.0407]. Hospital admission rates due to COVID-19 were higher in psychosis [OR adjusted: 2.90, 95% CI (2.36-3.56), p < 0.0001] and anxiety disorder groups [OR adjusted: 1.54, 95% CI (1.37-1.72), p < 0.0001]. Among admitted patients, COVID-19 mortality rate was decreased for those with affective disorders rate [OR adjusted: 0.72, 95% CI (0.55-0.95), p = 0.0194]. CONCLUSIONS: COVID-19-related mortality and hospitalizations rates were higher for patients with a pre-existing psychotic disorder.

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.

Influence of depression on survival of colorectal cancer patients drawn from a large prospective cohort.

OBJECTIVE: The prevalence of depressive symptoms immediately after the diagnosis of colorectal cancer (CRC) is high and has important implications both psychologically and on the course of the disease. The aim of this study is to analyse the association between depressive symptoms and CRC survival at 5 years after diagnosis. METHODS: This multicentre, prospective, observational cohort study was conducted on a sample of 2602 patients with CRC who completed the Hospital Anxiety and Depression Scale (HADS-D) at 5 years of follow-up. Survival was analysed using the Kaplan-Meier method and Cox regression models. RESULTS: According to our analysis, the prevalence of depressive symptoms after a CRC diagnosis was 23.8%. The Cox regression analysis identified depression as an independent risk factor for survival (HR = 1.47; 95% CI: 1.21-1.8), a finding which persisted after adjusting for sex (female: HR = 0.63; 95% CI: 0.51-0.76), age (>70 years: HR = 3.78; 95% CI: 1.94-7.36), need for help (yes: HR = 1.43; 95% CI: 1.17-1.74), provision of social assistance (yes: HR = 1.46; 95% CI: 1.16-1.82), tumour size (T3-T4: HR = 1.56; 95% CI: 1.22-1.99), nodule staging (N1-N2: HR = 2.46; 95% CI: 2.04-2.96), and diagnosis during a screening test (yes: HR = 0.71; 95% CI: 0.55-0.91). CONCLUSIONS: There is a high prevalence of depressive symptoms in patients diagnosed with CRC. These symptoms were negatively associated with the survival rate independently of other clinical variables. Therefore, patients diagnosed with CRC should be screened for depressive symptoms to ensure appropriate treatment can be provided.

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.

Psychometric properties of the EQ-5D-5L in patients with major depression: factor analysis and Rasch analysis.

BACKGROUND: The EQ-5D is one of the most recommended questionnaires for cost-effectiveness studies. AIMS: To study the psychometric properties of the EQ-5D-5L in patients with major depression. METHODS: This prospective observational study included 433 patients with major depression who completed the EQ-5D-5L and Patient Health Questionnaire-9 (PHQ-9) questionnaires at baseline, of whom 310 also did six months later. The structural validity was assessed by confirmatory factor analysis, the item functioning by item response analysis, and reliability by Cronbach's alpha. Convergent validity and known-groups validity was studied using the PHQ-9 and a general health question. To assess responsiveness effect sizes were calculated. RESULTS: The results supported the unidimensionality and showed adequate item functioning, with somewhat age-related item differential functioning for the mobility dimension. Cronbach's alpha was 0.77. The EQ-5D-5L showed a high correlation with the PHQ-9 and general health. The more severe the depression level and the poorer the general health, the lower the EQ-5D-5L scores (p < 0.001). Responsiveness parameters showed moderate changes among "improved" patients. CONCLUSIONS: These findings support the adequate psychometric properties of the EQ-5D-5L in patients with major depression. It could be very useful for clinicians and researchers as an outcome measure and for use in economic evaluation.

Health Related Quality of Life in Major Depressive Disorder: evolution in time and factors associated.

Major Depressive Disorder (MDD) is the most prevalent mental disorder. We aimed to analyze which factors were associated to their Health-Related Quality of Life (HRQoL) perception in patients diagnosed of MDD and how they evolved over six months.

Response Mapping Methods to Estimate the EQ-5D-5L From the Western Ontario McMaster Universities Osteoarthritis in Patients With Hip or Knee Osteoarthritis.

OBJECTIVES: The mapping technique can estimate generic preference-based measure scores through a specific measure that cannot be used in economic evaluations. This study compared 2 response mapping methods to estimate EQ-5D-5L scores using the Western Ontario McMaster Universities Osteoarthritis (WOMAC). METHODS: The sample consisted of 758 patients with the hip or knee osteoarthritis recruited in baseline. Bayesian networks (BN) and multinomial logistic regression (ML) were used as response mapping models. Predictions were obtained using the 6-month follow-up as a validation sample. The mean absolute error, mean squared error, deviation from the root mean squared error and intraclass correlation coefficient were calculated as precision measures. RESULTS: There was 5.5% of missing data, which was removed. The mean age was 69.6 years (standard deviation = 10.5), with 61.6% of women. The BN model presented lower mean absolute error, mean squared error, root mean squared error and higher intraclass correlation coefficient than the ML model. Only the WOMAC items pain and physical function items were related with the EQ-5D-5L dimensions. CONCLUSION: BN response mapping models are more robust methods, with better prediction results, than ML models. The BN model also provided a graphic representation of the dependency relationships between the EQ-5D-5L dimensions and the different WOMAC items that could be useful in the clinical investigation of patients with hip or knee osteoarthritis.

Use of the Robson Classification System to Assess Cesarean Delivery Rate in a Tertiary Hospital in the Basque Country.

OBJECTIVES: To assess the rate of cesarean delivery at Basurto University Hospital (Bilbao, Spain) between 2015 and 2017 and to determine the cause of an increase in this rate during 2017. METHODS: We retrospectively reviewed 6975 deliveries between 2015 and 2017, classifying women using the Robson classification. We analyzed extended perinatal mortality and perinatal outcomes during the study period and performed a comparative analysis of cesarean deliveries by year and Robson group. Comparisons were made with analysis of variance and χ2 or Fisher's exact tests. RESULTS: During the study period, 928 cesarean deliveries (13.3%) were performed. Extended perinatal mortality in this period was 7.0%. We detected an increase in the rate of cesarean delivery in 2017 in Group 1 women (P = 0.0224), with significant differences in the homogeneity of the distribution of cesarean deliveries performed for fetal distress between years in this group (P = 0.0093). Auditing the cases of cesareans performed for fetal distress in Group 1 in 2017, we found that the indication was appropriate in all cases, but in 39.4%, the management of uterine contractions during labour was considered suboptimal. CONCLUSION: Classifying cesarean deliveries using the Robson classification allows us to compare cesarean rates in different years and analyze any increases in these rates. Increases are sometimes attributed to changes in the obstetric population, but when investigated may be found to be related to potentially correctable problems. It is not necessary to have a high rate of cesarean delivery to warrant internal audit.

Risk scores to predict mortality 2 and 5 years after surgery for colorectal cancer in elderly patients.

BACKGROUND: The aim of this study was to identify predictors of mortality in elderly patients undergoing colorectal cancer surgery and to develop a risk score. METHODS: This was an observational prospective cohort study. Individuals over 80 years diagnosed with colorectal cancer and treated surgically were recruited in 18 hospitals in the Spanish National Health Service, between June 2010 and December 2012, and were followed up 1, 2, 3, and 5 years after surgery. Sociodemographic and clinical data were collected. The primary outcomes were mortality at 2 and between 2 and 5 years after the index admission. RESULTS: The predictors of mortality 2 years after surgery were haemoglobin ≤ 10 g/dl and colon locations (HR 1.02; CI 0.51-2.02), ASA class of IV (HR 3.55; CI 1.91-6.58), residual tumour classification of R2 (HR 7.82; CI 3.11-19.62), TNM stage of III (HR 2.14; CI 1.23-3.72) or IV (HR 3.21; CI 1.47-7), LODDS of more than - 0.53 (HR 3.08; CI 1.62-5.86)) and complications during admission (HR 1.73; CI 1.07-2.80). Between 2 and 5 years of follow-up, the predictors were no tests performed within the first year of follow-up (HR 2.58; CI 1.21-5.46), any complication due to the treatment within the 2 years of follow-up (HR 2.47; CI 1.27-4.81), being between 85 and 89 and not having radiotherapy within the second year of follow-up (HR 1.60; CI 1.01-2.55), no colostomy closure within the 2 years of follow-up (HR 4.93; CI 1.48-16.41), medical complications (HR 1.61; CI 1.06-2.44), tumour recurrence within the 2 years of follow-up period (HR 3.19; CI 1.96-5.18), and readmissions at 1 or 2 years of follow-up after surgery (HR 1.44; CI 0.86-2.41). CONCLUSION: We have identified variables that, in our sample, predict mortality 2 and between 2 and 5 years after surgery for colorectal cancer older patients. We have also created risks scores, which could support the decision-making process. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02488161 .

Toward Rigorous Materials Production: New Approach Methodologies Have Extensive Potential to Improve Current Safety Assessment Practices.

Advanced material development, including at the nanoscale, comprises costly and complex challenges coupled to ensuring human and environmental safety. Governmental agencies regulating safety have announced interest toward acceptance of safety data generated under the collective term New Approach Methodologies (NAMs), as such technologies/approaches offer marked potential to progress the integration of safety testing measures during innovation from idea to product launch of nanomaterials. Divided in overall eight main categories, searchable databases for grouping and read across purposes, exposure assessment and modeling, in silico modeling of physicochemical structure and hazard data, in vitro high-throughput and high-content screening assays, dose-response assessments and modeling, analyses of biological processes and toxicity pathways, kinetics and dose extrapolation, consideration of relevant exposure levels and biomarker endpoints typify such useful NAMs. Their application generally agrees with articulated stakeholder needs for improvement of safety testing procedures. They further fit for inclusion and add value in nanomaterials risk assessment tools. Overall 37 of 50 evaluated NAMs and tiered workflows applying NAMs are recommended for considering safer-by-design innovation, including guidance to the selection of specific NAMs in the eight categories. An innovation funnel enriched with safety methods is ultimately proposed under the central aim of promoting rigorous nanomaterials innovation.

Mapping WOMAC Onto the EQ-5D-5L Utility Index in Patients With Hip or Knee Osteoarthritis.

OBJECTIVES: To map the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) onto the EQ-5D-5L in patients with hip or knee osteoarthritis (OA). METHODS: A prospective observational study was conducted on 758 patients with hip or knee OA who completed the EQ-5D-5L and WOMAC questionnaires, of whom 644 completed them both again 6 months later. Baseline data were used to derive mapping functions. Generalized additive models were used to identify to which powers the WOMAC subscales should be raised to achieve a linear relationship with the response. For the modeling, general linear models (GLM), Tobit models, and beta regression models were used. Age, sex, and affected joints were also considered. Preferred models were selected based on Akaike and Bayesian information criteria, adjusted R2, mean absolute error (MAE), and root mean squared error (RMSE). The functions were validated with the follow-up data using MAE, RMSE, and the intraclass correlation coefficient. RESULTS: The preferred models were a GLM with Pain2+Pain3+Function+Pain·Function as covariates and a beta model with Pain3+Function+Function2+Function3 as covariates. The adjusted R2 were similar (0.6190 and 0.6136, respectively). The predictive performance of these models in the validation sample was similar and both models showed an overprediction for health states worse than death. CONCLUSION: To our knowledge, these are the first functions mapping the WOMAC onto the EQ-5D-5L in patients with hip or knee OA. They showed an acceptable fit and precision and could be very useful for clinicians and researchers when cost-effectiveness studies are needed and generic preference-based health-related quality of life instruments to derive utilities are not available.

Mapping analysis to predict EQ-5D-5 L utility values based on the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires in the Spanish population suffering from lower limb osteoarthritis.

BACKGROUND: The EQ-5D-5 L is a quality-of-life questionnaire based on individuals' preferences that is widely employed for cost-effectiveness analysis. Given the current demand for mapping algorithms to directly assign "utilities", this study aimed to generate different mapping models for predicting EQ-5D-5 L utility values based on scores of the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires provided by patients suffering from hip and knee osteoarthritis (OA), respectively, and to assess the predictive capability of these functions. METHODS: This was a prospective, observational study. Following the criteria of the American Rheumatism Association, 361 patients with hip OA and 397 with knee OA from three regions in Spain were included. Health-related quality of life (HRQoL) was assessed through the EQ-5D-5 L general questionnaire and the OHS and OKS specifically for lower limb OA. Based on the scores on the OHS and OKS questionnaires, EQ-5D-5 L utilities were estimated using 4 models: ordinary least squares (OLS), Tobit, generalized linear model (GLM), and beta regression (Breg). The models were validated on the same patients after 6 months: the mean absolute error (MAE) and mean squared error (MSE) with their 95% confidence intervals (CI), mean values of standard errors (SE), intraclass correlation coefficients (ICC), and Bland-Altman plots were obtained. RESULTS: The lowest MAEs were obtained using GLM and Breg models, with values of 0.1103 (0.0993-0.1214) and 0.1229 (0.1102-0.1335) for hip OA, and values of 0.1127 (0.1014-0.1239) and 0.1141 (0.1031-0.1251) for knee OA. MSE values were also lower using GLM and Breg. ICCs between predicted and observed values were around or over the 0.8 cut-off point. Bland-Altman plots showed an acceptable correlation, but precision was lower for subjects with worse HRQoL, which was also evident when comparing MAEs of the bottom and top halves of the utilities scale. Predictive equations for utilities based on OHS/OKS scores were proposed. CONCLUSIONS: The OHS and OKS scores allow for estimating EQ-5D-5 L utility indexes for patients with hip and knee OA, respectively, with adequate validity and precision. GLM and Breg produce the best predictions. The predictive power of proposed equations is more consistent for subjects in better health condition.

Impact of reducing the duration of antibiotic treatment on the long-term prognosis of community acquired pneumonia.

BACKGROUND: The optimal duration of antibiotic treatment for community-acquired pneumonia (CAP) is not well established. The aim of this study was to assess the impact of reducing the duration of antibiotic treatment on long-term prognosis in patients hospitalized with CAP. METHODS: This was a multicenter study assessing complications developed during 1 year of patients previously hospitalized with CAP who had been included in a randomized clinical trial concerning the duration of antibiotic treatment. Mortality at 90 days, at 180 days and at 1 year was analyzed, as well as new admissions and cardiovascular complications. A subanalysis was carried out in one of the hospitals by measuring C-reactive protein (CRP), procalcitonin (PCT) and proadrenomedullin (proADM) at admission, at day 5 and at day 30. RESULTS: A total of 312 patients were included, 150 in the control group and 162 in the intervention group. Ninety day, 180 day and 1-year mortality in the per-protocol analysis were 8 (2.57%), 10 (3.22%) and 14 (4.50%), respectively. There were no significant differences between both groups in terms of 1-year mortality (p = 0.94), new admissions (p = 0.84) or cardiovascular events (p = 0.33). No differences were observed between biomarker level differences from day 5 to day 30 (CRP p = 0.29; PCT p = 0.44; proADM p = 0.52). CONCLUSIONS: Reducing antibiotic treatment in hospitalized patients with CAP based on clinical stability criteria is safe, without leading to a greater number of long-term complications.

Evaluation of the Influence of Astrocytes on In Vitro Blood-Brain Barrier Models.

In vitro blood-brain barrier (BBB) models are a useful tool to screen the permeability and toxicity of new drugs. Currently, many different in vitro BBB models coexist, but none stands out as being notably better than the rest. Therefore, there is still a need to evaluate the quality of BBB models under various conditions and assess their ability to mimic the in vivo situation. In this study, two brain endothelial cell lines (bEnd.3 and hCMEC/D3) and two epithelial-like cell lines (MDCKII and Caco-2) were selected for BBB modelling purposes. They were grown as monolayers of a single cell type, under the following conditions: in coculture with either primary or immortalised astrocytes; or in the presence of primary or immortalised astrocyte-derived conditioned media. A total of 20 different BBB models were established in this manner, in order to assess the effects of the astroglial components on the BBB phenotype in each case. To this end, six parameters were studied: the expression of selected tight junction proteins; the enzyme activities of alkaline phosphatase and of gamma glutamyl transpeptidase; the transendothelial/transepithelial electrical resistance (TEER); restriction in paracellular transport; and efflux transporter inhibition were each evaluated and correlated. The results showed that coculturing with either primary or immortalised astrocytes led to a general improvement in all parameters studied, evidencing the contribution of this cell type to effective BBB formation. Furthermore, the permeability coefficient (P e) of the tracer molecule, Lucifer Yellow, correlated with three of the six parameters studied. In addition, this study highlights the potential for the use of the Lucifer Yellow P e value as an indicator of barrier integrity in in vitro BBB models, which could be useful for screening the permeability of new drugs.

EQ-5D-5L utilities per health states in Spanish population with knee or hip osteoarthritis.

BACKGROUND: The objective of this study was to obtain utilities by means of EQ-5D-5L for different health states in patients with knee osteoarthritis (KOA) or hip osteoarthritis (HOA) in Spain, and to compare these values with those used in foreign studies with the aim of discussing their transferability for their use in economic evaluations conducted in Spain. METHODS: Primary study: Observational prospective study of KOA or HOA patients in Spain. Sociodemographic and clinical characteristics were collected to characterize the sample. Utilities were elicited using the EQ-5D-5L questionnaire. ANOVA and bivariable analyses were conducted to identify differences between health states. LITERATURE REVIEW: Using the bibliographic databases NSH EED and CEA Registry, we conducted searches of model-based cost utilities analyses of technologies in KOA or HOA patients. Health states and utilities were extracted and compared with values obtained from the Spanish sample. RESULTS: Three hundred ninety-seven subjects with KOA and 361 subjects with HOA were included, with average utilities of 0.544 and 0.520, respectively. In both samples, differences were found in utilities according to level of pain, stiffness and physical function (WOMAC) and severity of symptoms (Oxford scales), so that the worst the symptoms, the lower the utilities. The utilities after surgery were higher than before surgery. Due to limitations from our study related to sample size and observational design, it was not possible to estimate utilities for approximately half the health states included in the published models because they were directly related to specific technologies. For almost 100% of health states of the selected studies we obtained very different utilities from those reported in the literature. CONCLUSIONS: To our knowledge this is the first article with detailed utilities estimated using the EQ-5D-5L in Spain for KOA and HOA patients. In both populations, utilities are lower for worse health states in terms of level of pain, stiffness and physical function according to WOMAC, and according to the Oxford scales. Most utilities obtained from the Spanish sample are lower than those reported in the international literature. Further studies estimating utilities from local populations are required to avoid the use of foreign sources in economic evaluations.

Psychometric properties of the EQ-5D-5L in patients with hip or knee osteoarthritis: reliability, validity and responsiveness.

PURPOSE: To study the psychometric properties, including reliability, validity and responsiveness, of the Spanish EQ-5D-5L questionnaire for patients with hip or knee osteoarthritis (OA). METHODS: We included 758 patients with hip or knee OA who completed the EQ-5D-5L and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, of whom 644 also did 6 months later. The EQ-5D-5L contains five questions from which a utility index is derived. The WOMAC covers three dimensions: pain, stiffness and physical function. Floor and ceiling effects were calculated. Reliability was assessed using Cronbach's alpha. Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L and WOMAC. We examined known-groups validity by comparing the EQ-5D-5L between subgroups defined by WOMAC scores using ANOVA or the Kruskal-Wallis test. Effect sizes were calculated to assess responsiveness, and minimal clinically important difference (MCID) was estimated. RESULTS: The EQ-5D-5L showed minimal floor and ceiling effects (< 3%). Cronbach's alpha was 0.86. The EQ-5D-5L index was strongly correlated with WOMAC pain and function scores (- 0.688 and - 0.782). Patients with higher WOMAC scores had significantly (p < 0.0001) lower EQ-5D-5L index. The 20.19% had hip or knee replacement during the follow-up. Effect sizes were small among non-surgical patients, but > 0.80 among "improved" surgical patients, being the MCID for improvement 0.32 points. CONCLUSIONS: The results support the reliability, validity and responsiveness of the EQ-5D-5L, overcoming the limitations of the EQ-5D-3L in these patients. Therefore, the EQ-5D-5L could be very useful as an outcome measure, at least in patients with hip or knee OA.

Scale invariance and longitudinal stability of the Physical Functioning Western Ontario and MacMaster Universities Osteoarthritis Index using the Rasch model.

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures the quality of life of patients with osteoarthritis (OA), and there is a specific scale for the physical functioning dimension, the short version with seven items WOMAC-pf. This study describes the application of the Rasch model to explore scale invariance and response stability of the WOMAC-pf short version across affected joint and over time. A sample of 884 patients with OA, from 15 hospitals in Spain, completed the WOMAC-pf before surgery (baseline) and at 3, 6 and 12 months post-surgery of hip or knee. The invariance by joint was explored through the differential item functioning (DIF) analysis of the Rasch model using baseline data, and time stability (DIF by time) were evaluated in stack data (each participant is represented four times, one by time point). Mean age of the patients was of 69.13 years (SD 10.01), 59.3% of them were women (n = 524), 59.2% had knee OA (n = 523) and 40.8% hip OA (n = 361). Item "putting on socks" showed DIF by joint and time. Fit to the Rasch model using stack data improved when this item was removed. Good reliability for individual use, local independency and unidimensionality of the models were confirmed. WOMAC-pf 7-item short version was invariant over time and joint when item "putting on socks" was removed. Researchers should carefully evaluate this item as it presents problems in scale invariance and stability, which could affect results when comparing data by joint or when computing change scores.

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.

Validation of the Spanish version of the Oxford knee score and assessment of its utility to characterize quality of life of patients suffering from knee osteoarthritis: a multicentric study.

BACKGROUND: Knee osteoarthritis (OA) represents a heavy burden for patients and the society as a whole. The Oxford Knee Score (OKS) is a well known tool to assess the quality of life in patients with Knee OA. The purpose of this study was to analyze the psychometric properties of the Spanish version of the OKS, including its reliability, validity, and responsiveness. METHODS: Prospective observational study that included 397 patients diagnosed with knee OA according to the criterion of the American Rheumatism Association, which were recruited in 3 different Spanish regions. Their self-perceived health-related quality of life (HRQL) was assessed through 3 questionnaires: a generic one (the EQ-5D-5 L) and two specific ones adapted to Spanish (the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Oxford Knee Score (OKS). The follow-up period was 6 months, and the acceptability of the OKS was evaluated, together with its psychometric properties, presence of ceiling and floor effects, validity, reliability, and sensitivity to change. RESULTS: The OKS was fully answered in 99.5% of cases, with no evidence of ceiling or floor effects. Its factor structure can be explained in a single dimension. Its discriminating capacity was very good compared to the groups generated by the WOMAC and the EQ-5D-5 L. The correlation of the OKS with the dimensions of the latter questionnaires was around 0.7. The test-retest reliability was excellent (ICC 0.993; CI 95%: 0.990-0.995) and so was its internal consistency (Cronbach's α = 0.920). The effect size was 0.7 for moderate improvements in the HQRL, which is similar to that of the dimensions of the WOMAC and greater than for the EQ-5D-5 L. The minimum clinically significant difference that was detected by the questionnaire was 6.1 points, and the minimum detectable change was 4.4 points. CONCLUSIONS: The Spanish-adapted version of the OKS is a useful, valid tool for assessing the perceived HRQL in patients suffering from knee OA, with psychometric properties similar to the WOMAC, and that allows for discriminating the patient's condition at a particular moment as well as for appraising changes over time.