All-cause community acquired pneumonia cost by age and risk in real-world conditions of care in Spain.

BACKGROUND: Economic burden of community-acquired pneumonia (CAP) is recognized. Few studies have documented such burden in adults stratified by age, risk status, and by care setting. Spanish data available is scarce. METHOD: A retrospective, multicenter study in seven regions of Spain (2017-2019) was conducted. Patients ≥18 years with a primary all-cause CAP episode diagnosis were identified. Episode-level variables included risk-stratum based on presence of an immunocompromising/chronic condition, age, number and length of hospitalized and outpatient episodes, and CAP-related healthcare costs/sick leaves were included. RESULTS: 7,108 episodes [mean age (SD): 59.2 (19.6), 50.42% male, 31.0% hospitalized] were analyzed. Low-risk group accounted for 47.7% of all CAP episodes, 31.5% moderate-risk and 20.8% high-risk. Pneumococcus was identified in 42.2% of cases. Mean CAP episode length was 22.9 days for hospitalized and 13.7 days for outpatient episode. Total healthcare cost for episode was higher in inpatient vs. outpatient: €3,955 vs. €511, p < 0.001, with higher sick leave cost (€3,281 vs. €2,632, p < 0.001), respectively. CONCLUSION: CAP required hospitalization cost is high regardless of age or comorbidities for the Spanish NHS. Given that almost half of the patients in this study did not have traditional risk factors for CAP, better preventative strategies should seriously be considered.

Adherence to Desvenlafaxine Versus Usual Care and Its Impact on Health Outcomes: A Comparative Real-world Clinical Study.

BACKGROUND AND OBJECTIVE: Low adherence to treatment is associated with poorer clinical outcome and greater healthcare resources utilization (HRU). Limited data are available on the extent of adherence to each individual antidepressant. The goal of this study was to compare the adherence rate to desvenlafaxine versus usual care with selective serotonin reuptake inhibitors (SSRI) and/or other serotonin-norepinephrine reuptake inhibitors (SNRI), in subjects with major depressive disorder (MDD). METHODS: Retrospective, multi-centric, observational study including 574 outpatients with MDD. Data were collected from mental and primary care centers. Adherence, persistence, effectiveness, and HRU was evaluated through multivariate regression models. RESULTS: At 12-months, adjusted adherence rate was higher with desvenlafaxine versus SNRI/SSRI, 67.9% versus 59.9% (OR 1.66, 95% CI 1.07-2.59, p = 0.024). Remission rate was numerically higher with desvenlafaxine versus SNRI/SSRI, 55.9% versus 50.1% (OR 1.35, 95% CI 0.93-1.98, p = 0.118), as well as treatment response, 76.5% in desvenlafaxine group versus 70.8% in SNRI/SSRI group (OR 1.25, 95% CI 0.82-1.90, p = 0.300). Medical visits use was higher in SNRI/SSRI than in desvenlafaxine group [9.8 (4.8) versus 9.1 (6.0), p = 0.019]. CONCLUSIONS: Desvenlafaxine is significantly associated with a higher adherence rate at 12 months compared to usual care based on SSRI or other SNRI. This suggests that desvenlafaxine could improve disease management having a positive impact on disease-associated costs.

Predictive and criterion validity of the Cervantes-SF menopause quality of life questionnaire.

OBJECTIVES: To determine the predictive and criterion-based validity of the Cervantes-SF scale that measures the impact of menopause on Health-Related Quality of Life. METHODS: We recruited a noninstitutionalized sample of peri/postmenopausal women aged 40 to 65 years, who had their last menstrual cycle 12+ months prior to inclusion in the study of the psychometric validity of the Cervantes-SF scale. Predictive validity of the scale was confirmed for various health outcome measures administered concomitantly (years of disability-free life expectancy, work productivity and impact on daily activities, economic impact arising from loss of work productivity, hours of undisturbed sleep each day, and the utilization of healthcare facilities), whilst criterion validity was determined by the likelihood of identifying a moderate-to-severe vasomotor or genital syndrome requiring specific treatment. RESULTS: A sample of 308 peri/postmenopausal women with a mean age of 55.7 years (SD: 5.3 y) was analyzed in this study. A score >25 points on the dimension of vasomotor problems (or menopausal health) showed values of sensitivity and specificity > 80% for identifying women with moderate-severe vasomotor syndrome requiring pharmacological treatment. Predictive validity was confirmed for menopause-related health outcomes. A change of 6.7 points in the scale score, equivalent to the value of its minimal difference, is indicative of a significant increase in the degree of disability regarding work/day-to-day activities, greater economic loss due to decreased work productivity, fewer years of life expectancy without disability, fewer hours of undisturbed sleep, and more visits to the physician per year due to menopausal symptoms. CONCLUSIONS: These results confirm the criterion and predictive validity of the Cervantes-SF scale in peri/postmenopausal women.

Population-based norms for the Cervantes-SF short-form questionnaire assessing health-related quality of life in menopause.

OBJECTIVES: To develop the population-based norms for the Cervantes-SF scale, which measures the impact of menopause on the health-related quality of life (HRQOL) of women in Spain. METHODS: We used a sample obtained from representative studies of the Spanish population according to geographic density and autonomous community. This sample was composed of 5,237 non- institutionalized peri- and post-menopausal women, aged 40-75 years. Measures of central tendency, dispersion and percentiles were calculated for the total score and its dimensions, in 11 three-year age categories. Construct validity was analyzed based on a comparison with known groups to confirm the validity of the normative scales. RESULTS: The norms show a monotonic gradient, with an incremental impact on HRQOL as age increases, as shown by an increase in the total score and each of the dimensions. Fifty percent of women showed that peri-/post-menopausal symptomatology interfered with HRQOL > 39 %, ranging from 25 % (40-44 years) to 47 % (72-75 years). The population norms showed significant differences between groups according to generic HRQOL, number of comorbidities, history of osteoporotic fracture, educational level, and presence of obesity. CONCLUSIONS: These results support the validity of the population-based norms for the Cervantes-SF scale, a valid instrument for measuring the impact of menopause on HRQOL in Spain. The norms obtained facilitate the interpretation of these scores in clinical practice, research, and health management.

Mapping of the Gastrointestinal Short Form Questionnaire (GSF-Q) into EQ-5D-3L and SF-6D in patients with gastroesophageal reflux disease.

BACKGROUND: The short, self-administered Gastroesophageal Reflux Disease (GERD) Symptom Frequency Questionnaire (GSFQ) is a specific Quality of Life (QoL) instrument which measures the impact of GERD symptoms on QoL. This study aims to map the specific scores in GSFQ into two generic instruments: SF-6D and EQ-5D-3 L, in order to obtain utility estimates derived from the GERD condition. METHOD: A national representative sample of GERD patients was selected, stratified by gender, age (< 45, ≥45 years) and GERD severity (0-I, II-IV Savary-Miller score) for validation purposes. Age, gender, BMI, GERD diagnose, GERD severity, associated comorbidities and risk factors were recorded. GSFQ, SF-6D, EQ-5D-3 L, and the HRQoL Visual Analogue Scale (VAS) were answered by patients. Several mapping methods were estimated, regression using dummy variables, and linear, quadratic and cubic regression using optimal factor scores. The use of a GERD aggregated summary severity derived from the GSFQ was dimed the best predictor. Overall Mean Absolute Error (MAE), overall Mean Absolute Percentage Error (MAPE) were used as goodness-of-fit (GOF) indexes to compare models. RESULTS: A total of 3405 patients were recruited by 490 clinicians. Mean age was 49 (±14.4) years and 49.8% were women. Reported comorbidities were clustered in 6 antecedents and 15 concomitant pathologies. Aggregation of levels for the frequency of symptoms items was found more suitable for estimation. Regression weights were found to follow a monotonous progressive pattern. Overall MAE ranged from 0.092 to 0.094 for SF-6D utility prediction and from 0.008 to 0.08 for EQ-5D-3 L, while MAPE values ranged from 27.9 to 29% for SF-6D and from 36.8 to 38.4% for EQ-5D-3 L. Cubic regression GOF demonstrated a better fit. CONCLUSIONS: It is possible to translate specific GSFQ scores assessing GERD condition into generic SF-6D and EQ-5D-3 L utility values. Although regression using dummy variables is a suitable mapping procedure, other alternative mapping methods convey better fit, in particular cubic regression.

Cost-effectiveness analysis of fesoterodine flexible dose in newly diagnosed patients with overactive bladder in routine clinical practice in Spain.

OBJECTIVE: To carry out cost-effectiveness analysis from the Spanish National Health System perspective, of treating overactive bladder (OAB), in newly diagnosed patients with two flexible doses of fesoterodine in routine clinical practice. PATIENTS AND METHODS: Economic evaluation of flexible-dose fesoterodine in newly diagnosed patients, including two treatment groups: standard escalating from 4 to 8 mg or fast escalating to 8 mg. Costs were estimated from health care resources utilization related to OAB, and were expressed in 2015 Euros. Quality-adjusted life-years (QALYs) were obtained from overactive bladder questionnaire-short form. Univariate and probabilistic sensitivity analyses were carried out. RESULTS: Three hundred and ninety symptomatic OAB patients treated with fesoterodine and newly diagnosed (141 in fast escalating group and 249 in standard escalating) were analyzed. Adjusted health care total costs were not statistically different; difference -€4.1 (confidence interval: -153.3; 25.1) P=0.842. QALYs were higher in fast escalating to high dose vs standard escalating group, resulting in a cost of -€16,020/QALY gained for fast escalating vs standard escalating group. CONCLUSION: When the cost-effectiveness threshold is set at a maximum value of €30,000/QALY gained, fesoterodine fast escalating group was cost-effective vs standard escalating group 67.6% of the time. The treatment with fesoterodine, in female patients newly diagnosed, fast escalating to 8 mg was a cost-effective option relative to escalating traditionally from 4 to 8 mg, in the management of OAB in routine clinical practice, from the Spanish National Health System perspective.

Assessing health-related quality of life in patients with breast cancer: a systematic and standardized comparison of available instruments using the EMPRO tool.

PURPOSE: The objective was to obtain a standardized evaluation of available specific and generic breast cancer health-related quality-of-life instruments. METHODS: We carried out systematic literature reviews in the PubMed and EMBASE databases to identify manuscripts which contained information regarding either the development process or metric properties of health-related quality-of-life instruments used among breast cancer patients. Each instrument was evaluated independently by two researchers, and occasionally a third one, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall score and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): concept and measurement model, reliability, validity, responsiveness, interpretability, burden, and alternative forms. RESULTS: FACT-B was the instrument with the best global performance, obtaining an overall EMPRO score of 79.27. It was also the most accurate instrument on the Concept and Measurement Model, Reliability, and Interpretability attributes. Four more instruments scored over 50 points on the overall score, which summarizes the five attribute-specific scores: EORTC BR-23, IBCSG, WHO-QOL BREF, and SF-36. An overall score of at least 50 points implies that the use of these instruments could be recommended for assessing health-related quality of life in breast cancer patients. CONCLUSION: The FACT-B scored the highest on overall on our EMPRO evaluation of instruments measuring health-related quality of life among breast cancer patients. However, depending on the purpose of the study, several instruments (EORTC BR-23, IBCSG, SF-36, and WHO-QOL BREF) have shown good performance in some of the specific individual dimensions included in the EMPRO.

Mapping of the OAB-SF Questionnaire onto EQ-5D in Spanish Patients with Overactive Bladder.

BACKGROUND AND OBJECTIVE: Mapping disease-specific measures onto generic preference-based indexes allows estimating utility values in specific conditions to determine gain of quality-adjusted-life-years when the status of condition varies. The aim of this study was to map a disease specific scale, the Overactive Bladder Questionnaire 5-dimensional health classification system (OAB-5D) derived from the Overactive Bladder questionnaire-Short Form (OABq-SF), onto a preference-based scale, the EuroQol-5D (EQ-5D), in a sample of patients with overactive bladder (OAB) in a Spanish population. METHOD: A survey addressed to value the health states was conducted among 246 patients at 18 clinics of urology from Spain. A total of 43 out of 243 possible health states have been valued, using VAS (Visual Analog Scale) and TTO (time trade-off) techniques. In addition, ordinary least squares (OLS), generalized linear models (GLM) and Tobit models were estimated. Resulting models were compared and the best one was selected in terms of goodness of fit measures, attribute sign, coefficient magnitude, and statistical significance of regression coefficients. Finally, the internal validity of the best model was calculated by bootstrap resampling. RESULTS: The best model to map the OAB-5D onto EQ-5D could be estimated and the stability of parameter estimations was proved. The mentioned model estimated through OLS regression attained R (2) value of 0.892, with the aggregated data; with GLM (efficient maximum likelihood regression), Pearson χ (2) of 15.3 has been obtained; AIC (Akaike information criterion) = -550.9 and BIC (Bayesian information criterion) = -475.4. OLS model included the following OABq-SF items (and range of weights): A1 (0.102, 0.216); A3 (0.070, 0.171); B3 (0.071, 0.078); B1 (0.076, 0.136); B2 (-0.132, -0.028). CONCLUSION: It is possible to map the OAB-5D scores onto EQ-5D in the Spanish population, allowing estimating EQ-5D utility scores from OAB specific health conditions.

Cost Effectiveness of the 13-Valent Pneumococcal Conjugate Vaccination Program in Chronic Obstructive Pulmonary Disease Patients Aged 50+ Years in Spain.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are at elevated risk of pneumococcal infection. A 13-valent pneumococcal conjugate vaccine (PCV13) was approved for protection against invasive disease and pneumonia caused by Streptococcus pneumoniae in adults. This study estimated the incremental cost-effectiveness ratio (ICER) of vaccinating COPD patients ≥50 years old with PCV13 compared with current vaccination policy (CVP) with 23-valent pneumococcal polysaccharide vaccine. METHODS: A Markov model accounting for the risks and costs for all-cause non-bacteremic pneumonia (NBP) and invasive pneumococcal disease (IPD) was developed. All parameters, such as disease incidence and costs (€; 2015 values), were based on published data. The perspective of the analysis was that of the Spanish National Healthcare System, and the horizon of evaluation was lifetime in the base case. Vaccine effectiveness considered waning effect over time. Outcomes and costs were both discounted by 3% annually. RESULTS: Over a lifetime horizon and for a 629,747 COPD total population, PCV13 would prevent 2224 cases of inpatient NBP, 3134 cases of outpatient NBP, and 210 IPD extra cases in comparison with CVP. Additionally, 398 related deaths would be averted. The ICER was €1518 per quality-adjusted life-year (QALY) gained for PCV13 versus CVP. PCV13 was found to be cost effective versus CVP from a 5-year modelling horizon (1302 inpatient NBP and 1835 outpatient NBP cases together with 182 deaths would be prevented [ICER €25,573/QALY]). Univariate and probabilistic sensitivity analyses confirmed the robustness of the model. CONCLUSIONS: At the commonly accepted willingness-to-pay threshold of €30,000/QALY gained, PCV13 vaccination in COPD patients aged ≥50 years was a cost-effective strategy compared with CVP from 5 years to lifetime horizon in Spain.

Psychometric attributes of the Cervantes short-form questionnaire for measuring health-related quality of life in menopausal women.

OBJECTIVE: To analyse the psychometric properties of the Cervantes scale short-form (SF) in the peri- and post-menopausal periods. METHODS: Outpatients women 45-65 years with menstrual problems associated with the climacteric syndrome were analysed. Original and SF versions of the Cervantes scale were administered along with the EuroQol-5D (EQ-5D) and work productivity and activity impairment questionnaire (WPAI) scales. Conceptual model, burden of administration, feasibility, reliability, criteria validity and construct validity were assessed. RESULTS: 317 women [55.7±5.3 years (mean±standard deviation)] were recruited: 75.4% were post- and 22.3% were peri-menopausal. The Cervantes-SF was completed in 2.5±1.6min, and 86% answered all items. Cronbach's α was 0.820, and ranged from 0.510 (Aging) to 0.918 (Vasomotor Symptoms) for individual dimensions. The scale structure matched the structure of the original version, χ(2)/(degrees of freedom)=3.6, Comparative Fit Index=0.848, Tucker-Lewis Index=0.850, and root mean square error of approximation=0.099, although differences were found between sexual activity statuses. Criteria validity was good (r=0.890), concurrent validity was congruent with a priori hypothesis using either the EQ-5D or the WPAI scales. The scale discriminated significantly the severity of both vasomotor and genital climacteric associated symptoms. CONCLUSION: The Cervantes-SF has shown good psychometric properties for measuring Health related quality of life in peri- and post-menopausal women who regularly attended gynaecology clinics in Spain.

Budgetary impact analysis on funding smoking-cessation drugs in patients with COPD in Spain.

The aim of the study was to assess the budgetary impact of funding smoking-cessation drugs in COPD patients in Spain. A hybrid model (cohort and Markov) was developed for a 5-year time horizon. Only approved cessation drugs (varenicline, bupropion, and nicotine replacement therapy) were considered. Irrespective of the drug, the model allowed for an initial cessation attempt, and up to three additional attempts in case of failure or smoking relapse during a 5-year period. Drug effectiveness was based on controlled clinical trials. National Health System perspective was applied; therefore, only medical resources were included. The pharmaceutical costs for smoking-cessation drugs, extra medical follow-up as a consequence of public reimbursement, and annual savings for health costs avoided due to stopping smoking were considered. The model estimated that 17,756 COPD patients would stop smoking if public funding was available, compared with 1,303 without reimbursement. In the reimbursement scenario, the savings accounted for a total of €48.0 million, compensating for expenditures on drugs and medical visits (€40.4 million). Accumulated total additional savings in 5 years (€4.3 million) compared with the scenario without reimbursement was shown. Sensitivity analyses supported the results robustness. Funding smoking-cessation drugs in COPD patients seems to be an efficient option and a National Health System drug reimbursement scheme would represent a cost-saving policy in Spain.

Modeling the longitudinal latent effect of pregabalin on self-reported changes in sleep disturbances in outpatients with generalized anxiety disorder managed in routine clinical practice.

BACKGROUND: Anxiety disorders are among the most common psychiatric illnesses, with generalized anxiety disorder (GAD) being one of the most common. Sleep disturbances are highly prevalent in GAD patients. While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials, mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin. Thus, the objective of this study was to model the longitudinal latent effect of pregabalin or usual care (UC) therapies on changes in sleep in outpatients with GAD under routine clinical practice. METHODS: Male and female GAD outpatients, aged 18 years or above, from a 6-month prospective noninterventional trial were analyzed. Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms (assessed with Hamilton Anxiety Scale) and sleep disturbances (assessed with Medical Outcomes Study-Sleep Scale [MOS-S]) were estimated by a conditional latent curve model applying structural equation modeling. RESULTS: A total of 1,546 pregabalin-naïve patients were analyzed, 984 receiving pregabalin and 562 UC. Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval) score reductions in subjects receiving pregabalin: -15.9 (-15.2; -16.6) vs -14.5 (-13.5; -15.5), P=0.027, in Hamilton Anxiety Scale; and -29.7 (-28.1; -31.3) vs -24.0 (-21.6; -26.4), P<0.001, in MOS-S. The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant (γ =-3.99, P<0.001), after discounting the effect on reduction in anxiety symptoms. A mediation model showed that 70% of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement. CONCLUSION: A substantial proportion of the incremental improvements in anxiety-related sleep disturbances with pregabalin vs UC were explained by its direct effect, not mediated by improvements in anxiety symptoms.

Disability-adjusted-life-years losses in postmenopausal women with osteoporosis: a burden of illness study.

BACKGROUND: To estimate the disability-adjusted life years (DALY) in a nationwide representative sample of postmenopausal women with osteoporosis. The effects of drug-based therapy and risk factors for osteoporotic bone fractures on DALY losses were also explored. METHODS: DALY were estimated based on participant's clinical characteristics and Health-Related Quality-of-Life (HRQoL) data obtained from a cross-sectional, epidemiological one-visit study (the GINERISK study). The study enrolled postmenopausal women (at least 12-months after their last menstrual period) with osteoporosis, above 18-years old, who attended Spanish outpatient Gynaecology clinics. HRQoL was assessed using the generic SF-12v2 questionnaire, which was used to derive disutility values. Mortality rates were extracted from the Spanish national statistics database. Factors explored to be associated with DALY losses were examined using ANOVA, ANCOVA and MANCOVA models. RESULTS: DALY could be computed in 2,782 (67%) out of 4,157 postmenopausal women, with a mean (95% CI) age of 61.0 (60.7-61.2) years. Overall individual undiscounted DALY per woman were 6.1 (5.9-6.2), resulting to be significantly higher in women with severe osteoporosis with prior bone fracture; 7.8 (7.2-8.4) compared to osteoporotic women [5.8 (5.6-6.0)] or postmenopausal women with a BMD > -2.5 T-score that received a drug-based therapy [6.2 (5.8-6.5)]; F = 27.0 (P < 0.01). Models explaining the variation in the levels of health based on the use of a selective estrogen receptor modulator (SERM) or possession of risk factors for osteoporotic BF were found (P < 0.05). CONCLUSIONS: DALY losses were considerable amongst postmenopausal women with osteoporosis. Not having a prior bone fracture, being older, using a SERM and having less osteoporotic risk factors were all linked to less DALY losses.

Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors.

BACKGROUND: This study is done to compare the effect of adjunctive therapy with pregabalin versus usual care (UC) on health-care costs and clinical and patients consequences in generalized anxiety disorder (GAD) subjects with partial response (PR) to a previous selective serotonin reuptake inhibitor (SSRI) course in medical practice in Spain. METHODS: Post hoc analysis of patients with PR to SSRI monotherapy enrolled in a prospective 6-month naturalistic study was done. PR was defined as a Clinical Global Impression (CGI) scale score ≥3 and insufficient response with persistence of anxiety symptoms ≥16 in the Hamilton Anxiety Rating Scale (HAM-A). Two groups were analyzed: 1) adjunctive therapy (AT) with pregabalin (150-600 mg/day) to existing therapy and 2) UC (switching to a different SSRI or adding another anxiolytic different than pregabalin). Costs included GAD-related health-care resources utilization. Consequences were a combination of psychiatrist-based measurements [HAM-A, CGI, and Montgomery-Asberg Depression Rating Scale (MADRS)] and patient-reported outcomes [Medical Outcomes Study Sleep (MOS-sleep) scale, disability (World Health Organization Disability Assessment Schedule II (WHO-DAS II) and quality-of-life (Euro Qol-5D (EQ-5D)]. Changes in both health-care costs and scale scores were compared separately at end-of-trial visit by a general linear model with covariates. RESULTS: Four hundred eighty-six newly prescribed pregabalin and 239 UC GAD patients [mean (SD) HAM-A 26.7 (6.9) and CGI 4.1 (0.5)] were analyzed. Adding pregabalin was associated with significantly higher mean (95% CI) score reductions vs. UC in HAM-A [-14.9 (-15.6; -14.2) vs. -11.2 (-12.2; -10.2), p < 0.001] and MADRS [-11.6 (-12.2; -10.9) vs. -7.8 (-8.7; -6.8), p < 0.001]. Changes in all patient-reported outcomes favored significantly patients receiving pregabalin, including quality-of-life gain; 26.4 (24.7; 28.1) vs. 19.4 (17.1; 21.6) in the EQ-VAS, p < 0.001. Health-care costs were significantly reduced in both cohorts yielding similar 6-month costs; €1,565 (1,426; 1,703) pregabalin and €1,406 (1,200; 1,611) UC, p = 0.777. The effect of sex on costs and consequences were negligible. CONCLUSION: In medical practice, GAD patients with PR to SSRI experienced greater consequence improvements with adjunctive therapy with pregabalin versus UC, without increasing health-care cost. The effect of pregabalin was independent of patient gender.

Disability in bipolar I disorder: the 36-item World Health Organization Disability Assessment Schedule 2.0.

BACKGROUND: The WHODAS 2.0 is an ICF-based multidimensional instrument developed for measuring disability. The present study analyzes the utility of the 36-item interviewer-administered version in a sample of patients with bipolar disorder. There is no study to date that analyses how the scale works in a sample that only comprises such patients. METHODS: A total of 291 patients with bipolar disorder (42.6% males) according to DSM-IV-TR criteria from a cross-sectional study conducted in outpatient psychiatric clinics were enrolled. In addition to the WHODAS 2.0, patients completed a comprehensive assessment battery including measures on psychopathology, functionality and quality of life. Analyses were centered on providing evidence on the validity and utility of the Spanish version of the WHODAS 2.0 in bipolar patients. RESULTS: Participation domain had the highest percentage of missing data (2.7%). Confirmatory factorial analysis was used to test three models formulated in the literature: six primary correlated factors, six primary factors with a single second-order factor, and six primary factors with two second-order factors. The three models were plausible, although the one formed by six correlated factors produced the best fit. Cronbach's alpha values ranged between .73 for the Self-care domain and .92 for Life activities, and the internal consistency of the total score was .96. Relationships between the WHODAS 2.0 and measures of psychopathology, functionality and quality of life were in the expected direction, and the scale was found to be able to differentiate among patients with different intensity of clinical symptoms and work situation. LIMITATIONS: The percentage of euthymic patients was considerable. However, the assessment of euthymic patients is less influenced by mood. Some psychometric properties have not been studied, such as score stability and sensitivity to change. CONCLUSIONS: The Spanish version of the 36-item WHODAS 2.0 has suitable psychometric properties in terms of reliability and validity when applied to patients with bipolar disorder. Disability in bipolar patients is especially prominent in Cognition, Getting along, Life activities, and Participation domains, so functional remediation interventions should emphasize these areas in order to improve the daily living activities of these patients.

Structural validity of a 16-item abridged version of the Cervantes Health-Related Quality of Life scale for menopause: the Cervantes Short-Form Scale.

OBJECTIVE: The Cervantes Scale is a specific health-related quality of life questionnaire that was originally developed in Spanish to be used in Spain for women through and beyond menopause. It contains 31 items and is time-consuming. The aim of this study was to produce an abridged version with the same dimensional structure and with similar psychometric properties. METHODS: A representative sample of 516 postmenopausal women (mean [SD] age, 57 [4.31] y) seen in outpatient gynecology clinics and extracted from an observational cross-sectional study was used. Item analysis, internal consistency reliability, item-total and item-dimension correlations, and item correlation with the 12-item Medical Outcomes Study Short Form Health Survey Version 2.0 were studied. Dimensional and full-model confirmatory factor analyses were used to check structure stability. A threefold cross-validation method was used to obtain stable estimates by means of multigroup analysis. RESULTS: The scale was reduced to a 16-item version, the Cervantes Short-Form Scale, containing four main dimensions (Menopause and Health, Psychological, Sexuality, and Couple Relations), with the first dimension composed of three subdimensions (Vasomotor Symptoms, Health, and Aging). Goodness-of-fit statistics were better than those of the extended version (χ(2)/df = 2.493; adjusted goodness-of-fit index, 0.802; parsimony comparative fit index, 0.749; root mean standard error of approximation, 0.054). Internal consistency was good (Cronbach's α = 0.880). Correlations between the extended and the reduced dimensions were high and significant in all cases (P < 0.001; r values ranged from 0.90 for Sexuality to 0.969 for Vasomotor Symptoms). CONCLUSIONS: The Cervantes Scale can be reduced to a 16-item abridged version (Cervantes Short-Form Scale) that maintains the original dimensional structure and psychometric properties. At 51% of the original length, this version can be administered faster, making it especially suitable for routine medical practice.

Modeling the predictive value of pain intensity on costs and resources utilization in patients with peripheral neuropathic pain.

OBJECTIVE: The aim of the present analysis was to model the association and predictive value of pain intensity on cost and resource utilization in patients with chronic peripheral neuropathic pain (PNP) treated in routine clinical practice settings in Spain. METHODS: We performed a secondary economic analysis based on data from a multicenter, observational, and prospective cost-of-illness study in patients with chronic PNP that is refractory to prior treatment. Pain intensity was measured using the Short-Form McGill Pain Questionnaire. Univariate and multivariate linear regression models were fitted to identify independent predictors of cost and health care/non-health care resource utilization. RESULTS: A total of 1703 patients were included in the current analysis. Pain intensity was an independent predictor of total costs ([total costs]=35.6 [pain intensity]+214.5; coefficient of determination [R(2)]=0.19, P<0.001), direct costs ([direct costs]=10.8 [pain intensity]+257.7; R=0.06, P<0.001), and indirect costs ([indirect costs]=24.8 [pain intensity]-43.4; R(2)=0.20, P<0.001) related to chronic PNP in the univariate analysis. Pain intensity remains significantly associated with total costs, direct costs, and indirect costs after adjustment by other covariates in the multivariate analysis (P<0.001). None of the other variables considered in the multivariate analysis were predictors of resource utilization. DISCUSSION: Pain intensity predicts the health care and non-health care resource utilization, and costs related to chronic PNP. Management of patients with drugs associated with a higher reduction of pain intensity may have a greater impact on the economic burden of that condition.

Validación psicométrica de las escalas OAB-V8 y OAB-V3 para la detección de pacientes con probable vejiga hiperactiva en la población española / Psychometric validation of the OAB-V8 and OAB-V3 scales for the screening of patients with probable overactive bladder in the Spanish population

Fundamento y objetivo: Realizar la validación psicométrica en la población española de la escala Overactive Bladder Awareness Tool (OAB-V8), y de su versión abreviada, OAB-V3, para la detección de pacientes con probable vejiga hiperactiva (VH). Pacientes y método: Estudio transversal en población general > 18 años realizado por vía telemática (Internet) sobre una población representativa de la prevalencia de VH en la población española. Las propiedades evaluadas incluyeron factibilidad, fiabilidad y validez. Los sujetos incluidos fueron clasificados según la probabilidad de VH usando un algoritmo automatizado validado previamente. Se realizó análisis de curvas ROC y se determinaron sensibilidad, especificidad, y valores predictivos positivo y negativo. Resultados: Se incluyeron 2.035 sujetos, con una edad media + DE de 52,7 + 12,1 años (50,8% varones). El 13,7% fue clasificado como «Probable»; el 27,9% como «Posible» y el 58,3% como «No» VH. La consistencia interna para las escalas OAB-V8 y OAB-V3 fue alta (0,894 y 0,851 respectivamente), con correlaciones ítem-total asimismo elevadas en ambos casos (0,87-0,88 y 0,71-0,83 respectivamente). Ambas escalas fueron fiables con coeficientes de correlación intraclase de 0,826 (intervalo de confianza del 95%: 0,695-0,901) y 0,828 (intervalo de confianza del 95%: 0,623-0,922), respectivamente. El punto de corte óptimo en la escala OAB-V8 para identificar probable VH fue ≥ 8 puntos (área bajo la curva 0,895; sensibilidad 0,875 y especificidad 0,735), mientras que en la OAB-V3 fue ≥ 3 (área bajo la curva 0,910, sensibilidad 0,828 y especificidad 0,825). Conclusión: Las escalas OAB-V8 y OAB-V3 resultaron ser herramientas útiles de cribado autoadministrado por vía telemática, factibles, fiables y válidas para la detección de pacientes con probable VH en la población general en España (AU)

Background and objective: To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB). Patients and methods: A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity. Subjects were classified according to the likelihood of OAB, using an automated algorithm validated previously. ROC curve analysis was performed, and the sensitivity, specificity, and positive and negative predictive values were also assessed. Results: A total of 2,035 subjects with a mean + SD age of 52.7 + 12.1 years were included (50.8%) men. In total 13.7% were classified as «Probable», 27.9% «Possible», and 58.3% «No» OAB. The internal consistency of both OAB-V8 and OAB-V3 scales was high (0.894 and 0.851, respectively). The item-total correlation coefficients were high; 0.87-0.88 and 0.71-0.83, respectively. Intraclass correlation coefficient for OAB-V8 was 0.826 (confidence interval 95% 0.695-0.901) and it was 0.828 (confidence interval 0.623-0.922) for OAB-V3. The optimum cut-off value of OAB-V8 for detecting probable OAB was ≥ 8 points (AUC = 0.895, sensitivity 0.875, specificity 0.735), while for the OAB-V3 it was ≥ 3 (AUC = 0.910, sensitivity 0.828, specificity 0.825). Conclusion: Both OAB-V8 and OAB-V3 scales were considered useful online self-administered screening tools, which were also feasible, reliable and valid for the detection of patients with probable OAB in the general population in Spain (AU)

[Psychometric validation of the OAB-V8 and OAB-V3 scales for the screening of patients with probable overactive bladder in the Spanish population]. / Validación psicométrica de las escalas OAB-V8 y OAB-V3 para la detección de pacientes con probable vejiga hiperactiva en la población española.

BACKGROUND AND OBJECTIVE: To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB). PATIENTS AND METHODS: A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity. Subjects were classified according to the likelihood of OAB, using an automated algorithm validated previously. ROC curve analysis was performed, and the sensitivity, specificity, and positive and negative predictive values were also assessed. RESULTS: A total of 2,035 subjects with a mean+SD age of 52.7+12.1 years were included (50.8%) men. In total 13.7% were classified as «Probable¼, 27.9% «Possible¼, and 58.3% «No¼ OAB. The internal consistency of both OAB-V8 and OAB-V3 scales was high (0.894 and 0.851, respectively). The item-total correlation coefficients were high; 0.87-0.88 and 0.71-0.83, respectively. Intraclass correlation coefficient for OAB-V8 was 0.826 (confidence interval 95% 0.695-0.901) and it was 0.828 (confidence interval 0.623-0.922) for OAB-V3. The optimum cut-off value of OAB-V8 for detecting probable OAB was≥8 points (AUC=0.895, sensitivity 0.875, specificity 0.735), while for the OAB-V3 it was ≥ 3 (AUC=0.910, sensitivity 0.828, specificity 0.825). CONCLUSION: Both OAB-V8 and OAB-V3 scales were considered useful online self-administered screening tools, which were also feasible, reliable and valid for the detection of patients with probable OAB in the general population in Spain.