Olatz Garin

Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases

BackgroundThe WHODAS-2 is a disability assessment instrument based on the conceptual framework of the International Classification of Functioning, Disability, and Health (ICF). It provides a global measure of disability and 7 domain-specific scores. The aim of this study was to assess WHODAS-2 conceptual model and metric properties in a set of chronic and prevalent clinical conditions accounting for a wide scope of disability in Europe.Methods1,119 patients with one of 13 chronic conditions were recruited in 7 European centres. Participants were clinically evaluated and administered the WHODAS-2 and the SF-36 at baseline, 6 weeks and 3 months of follow-up. The latent structure was explored and confirmed by factor analysis (FA). Reliability was assessed in terms of internal consistency (Cronbachs alpha) and reproducibility (intra-class correlation coefficients, ICC). Construct validity was evaluated by correlating the WHODAS-2 and SF-36 domains, and comparing known groups based on the clinical-severity and work status. Effect size (ES) coefficient was used to assess responsiveness. To assess reproducibility and responsiveness, subsamples of stable (at 6 weeks) and improved (after 3 moths) patients were defined, respectively, according to changes in their clinical-severity.ResultsThe satisfactory FA goodness of fit indexes confirmed a second order factor structure with 7 dimensions, and a global score for the WHODAS-2. Cronbachs alpha ranged from 0.77 (self care) to 0.98 (life activities: work or school), and the ICC was lower, but achieved the recommended standard of 0.7 for four domains. Correlations between global WHODAS-2 score and the different domains of the SF-36 ranged from -0.29 to -0.65. Most of the WHODAS-2 scores showed statistically significant differences among clinical-severity groups for all pathologies, and between working patients and those not working due to ill health (p < 0.001). Among the subsample of patients who had improved, responsiveness coefficients were small to moderate (ES = 0.3-0.7), but higher than those of the SF-36.ConclusionsThe latent structure originally designed by WHODAS-2 developers has been confirmed for the first time, and it has shown good metric properties in clinic and rehabilitation samples. Therefore, considerable support is provided to the WHODAS-2 utilization as an international instrument to measure disability based on the ICF model.

Health-Related Quality of Life 2 Years After Treatment With Radical Prostatectomy, Prostate Brachytherapy, or External Beam Radiotherapy in Patients With Clinically Localized Prostate Cancer

PURPOSE To compare treatment impact on health-related quality of life (HRQL) in patients with localized prostate cancer, from before treatment to 2 years after the intervention. METHODS AND MATERIALS This was a longitudinal, prospective study of 614 patients with localized prostate cancer treated with radical prostatectomy (134), three-dimensional external conformal radiotherapy (205), and brachytherapy (275). The HRQL questionnaires administered before and after treatment (months 1, 3, 6, 12, and 24) were the Medical Outcomes Study 36-Item Short Form, the Functional Assessment of Cancer Therapy (General and Prostate Specific), the Expanded Prostate Cancer Index Composite (EPIC), and the American Urological Association Symptom Index. Differences between groups were tested by analysis of variance and within-group changes by univariate repeated-measures analysis of variance. Generalized estimating equations (GEE) models were constructed to assess between-group differences in HRQL at 2 years of follow-up after adjusting for clinical variables. RESULTS In each treatment group, HRQL initially deteriorated after treatment with subsequent partial recovery. However, some dimension scores were still significantly lower after 2 years of treatment. The GEE models showed that, compared with the brachytherapy group, radical prostatectomy patients had worse EPIC sexual summary and urinary incontinence scores (-20.4 and -14.1; p < 0.001), and external radiotherapy patients had worse EPIC bowel, sexual, and hormonal summary scores (-3.55, -5.24, and -1.94; p < 0.05). Prostatectomy patients had significantly better EPIC urinary irritation scores than brachytherapy patients (+4.16; p < 0.001). CONCLUSIONS Relevant differences between treatment groups persisted after 2 years of follow-up. Radical prostatectomy had a considerable negative effect on sexual functioning and urinary continence. Three-dimensional conformal radiotherapy had a moderate negative impact on bowel functioning, and brachytherapy caused moderate urinary irritation. These results provide relevant information for clinical decision making.

Disease-specific health-related quality of life questionnaires for heart failure: a systematic review with meta-analyses.

BackgroundHeart failure (HF) is an increasingly common condition affecting patients’ health-related quality of life (HRQL). However, there is little literature comparing HF-specific instruments. Our aim was to evaluate and compare data on the conceptual model and metric properties (reliability, validity and responsiveness) of HF-specific HRQL instruments, by performing a systematic review with meta-analyses.Methods and resultsOf 2,541 articles initially identified, 421 were full-text reviewed. Ninety-four reported data on five questionnaires: Minnesota Living with Heart Failure Questionnaire (MLHFQ), Chronic Heart Failure Questionnaire (CHFQ), Quality of Life Questionnaire for Severe Heart Failure (QLQ-SHF), Kansas City Cardiomyopathy Questionnaire (KCCQ) and Left Ventricular Dysfunction (LVD-36) questionnaire. Metric properties (reliability, validity and responsiveness) were summarised using meta-analysis for pools above five estimates. Cronbach’s alpha coefficients were generally high (0.83–0.95) for overall scores and scales measuring physical health. Associations with four validity criteria (New York Heart Association [NYHA] class, six-minute walk test [6MWT] and short form-36 [SF-36] ‘Physical’ and ‘Social Functioning’) were moderate to strong (0.41–0.84), except for those between two CHFQ domains (fatigue and dyspnoea) and the NYHA (0.19 and 0.22). Pooled estimates of change from eight meta-analyses showed the MLHFQ to be highly responsive, with changes in overall score ranging from −9.6 (95% confidence interval [CI]: −4.1; −15.2) for placebo to −17.7 (95% CI: −15.3; −20.2) for pacing devices. The CHFQ and KCCQ also showed good sensitivity to change.ConclusionsMost of the questionnaires studied met minimum psychometric criteria, though current evidence would primarily support the use of the MLHFQ, followed by the KCCQ and CHFQ.

Development of EMPRO: a tool for the standardized assessment of patient-reported outcome measures.

OBJECTIVE This study was aimed to develop a tool for the standardized assessment of patient-reported outcomes (PROs) to assist the choice of instruments. METHODS An expert panel adapted the eight attributes proposed by the Medical Outcomes Trust as evaluation review criteria, created items to evaluate them, and included a response scale for each item. A pilot test was designed to test the new tools feasibility and to obtain preliminary information concerning its psychometric properties. The Spanish versions of five measures were selected for assessment: the SF-36 Health Survey, the Nottingham Health Profile, the COOP-WONCA charts, the EuroQol-5D, and the Quality of Life Questionnaire EORTC-QLQ-C30. We assessed the new tools reliability (Cronbachs alpha and intraclass correlation coefficient [ICC]) and construct validity. RESULTS The new EMPRO (Evaluating the Measurement of Patient-Reported Outcomes) tool has 39 items covering eight key attributes: conceptual and measurement model, reliability, validity, responsiveness, interpretability, burden, alternative modes of administration, and cross-cultural and linguistic adaptations. Internal consistency was high (alpha = 0.95) as was interrater concordance (ICC: 0.87-0.94). Positive associations consistent with a priori hypotheses were observed between EMPRO attribute scores and the number of articles identified for the measures, the years elapsed since the publication of the first article, and the number of citations. CONCLUSION A new tool for the standardized assessment of PRO measures is available. It has shown good preliminary reliability and validity and should be a useful aid to investigators who need to choose between alternative measures. Further assessment of the tool is necessary.

Influenza Vaccine Effectiveness in Preventing Outpatient, Inpatient, and Severe Cases of Laboratory-Confirmed Influenza

BACKGROUND In most seasons, the influenza vaccine is effective in preventing influenza, but it is not clear whether it is equally effective in preventing mild and severe cases. We designed a case-control study to compare the effectiveness of the influenza vaccine in preventing outpatient, inpatient, and severe or fatal cases of laboratory-confirmed influenza. METHODS Hospitalized patients (n = 691) with laboratory-confirmed influenza in the 2010-2011 season recruited in 29 Spanish hospitals were individually matched by age, admission/visit date, and province with an outpatient with laboratory-confirmed influenza and an outpatient control. Severe cases were considered those patients admitted to intensive care units or who died in the hospital (n = 177). We compared the influenza vaccine status of controls and outpatient cases, inpatient cases, and severe cases using conditional logistic regression adjusted for potential confounding factors. Severe and nonsevere inpatient influenza cases were compared using unconditional logistic regression. Vaccine effectiveness was (1 - odds ratio) × 100. RESULTS Vaccine effectiveness was 75% (adjusted odds ratio [AOR], 0.25; 95% confidence interval [CI], .16-.39) in preventing influenza outpatient cases, 60% (AOR, 0.40; 95% CI, .25-.63) in preventing influenza-associated hospitalizations, and 89% (AOR, 0.11; 95% CI, .04-.37) in preventing severe cases. In inpatients, influenza vaccination was associated with a lower risk of severe influenza (AOR, 0.42; 95% CI, .22-.80). CONCLUSIONS Influenza vaccination prevented influenza cases and hospitalizations and was associated with a better prognosis in inpatients with influenza. The combined effect of these 2 mechanisms would explain the high effectiveness of the vaccine in preventing severe cases due to influenza.

Validity of the Spanish version of the Chronic Liver Disease Questionnaire (CLDQ) as a standard outcome for quality of life assessment

The Chronic Liver Disease Questionnaire (CLDQ) measures the impact on quality of life of chronic liver diseases, regardless of underlying etiology. The aim of this study was to develop a Spanish version of the CLDQ, and to assess its acceptability, reliability, validity, and sensitivity to change. The forward and back‐translation method by bilingual translators, with expert panel and pilot testing on patients, was used for the adaptation. The final version was self‐administered, together with the Short Form‐36 Health Survey (SF‐36), on 149 consecutive patients with chronic liver disease. Child‐Turcotte‐Pugh scores were evaluated by a physician. To assess reproducibility and responsiveness the CLDQ was readministered to a subsample of stable patients and to those who had received a liver transplant. Validity was evaluated via exploratory factor analysis, the CLDQ pattern across severity groups, and correlation coefficients with “itching” and SF‐36 scores. Cronbachs alpha and Intraclass Correlation Coefficient for CLDQ global score were 0.93 and 0.90, respectively, demonstrating good reliability. Validity was supported by correlations of the CLDQ with SF‐36 and “itching,” and CLDQ severity gradient (global score means were 5.5, 5.2, 5.0, and 4.5 in patients with no cirrhosis, cirrhosis Child‐Turcotte‐Pugh A, B, and C, respectively; P = 0.012). Responsiveness was shown by a high CLDQ improvement in patients who had received liver transplant (mean change = −1.4; P < 0.001). In conclusion, the Spanish CLDQ is reliable, valid, responsive, and equivalent to the original. These findings support its use as a standard outcome for patients with chronic liver diseases within the whole severity range, from “no cirrhosis” to transplant recipients, both in Spanish and international studies. Liver Transpl 12:95–104, 2006.

Validación de la versión española del Minnesota Living with Heart Failure Questionnaire

Introduccion y objetivos El Minnesota Living with Heart Failure Questionnaire (MLHFQ) es el instrumento mas utilizado para la evaluacion de la calidad de vida en pacientes con insuficiencia cardiaca. Contiene 21 items y dos dimensiones: fisica y emocional. El objetivo de este estudio es evaluar las propiedades metricas de la version espanola del MLHFQ. Metodos Se aplico, 1 y 2 meses despues del alta, el MLHFQ y el SF-36 a 677 pacientes ingresados por insuficiencia cardiaca. A partir de la clasificacion NYHA y otras 3 variables de capacidad funcional, se definio a los pacientes como estables (n = 245) o con cambio (n = 103). De la fiabilidad, se estudio: la consistencia interna (alfa de Cronbach) y la reproducibilidad (coeficiente de correlacion intraclase [CCI]). La validez se estudio con las puntuaciones segun la clase funcional y las correlaciones con las dimensiones del SF-36. La sensibilidad al cambio se evaluo por el tamano del efecto. Resultados El alfa de Cronbach fue ≥0,8 en las tres puntuaciones, y el CCI tambien fue elevado (0,74-0,83). Las puntuaciones del MLHFQ mostraron diferencias segun la clase funcional (p Conclusiones La version espanola del MLHFQ ha mostrado unas adecuadas propiedades metricas, igual que la original. Estos resultados respaldan el uso del MLHFQ en pacientes espanoles con insuficiencia cardiaca, aunque seria recomendable reevaluar su sensibilidad al cambio.

Assessing health-related quality of life in patients with heart failure: a systematic, standardized comparison of available measures

To systematically evaluate available health-related quality of life (HRQL) instruments for use in patients with heart failure (HF). Seven HF-specific HRQL questionnaires and associated studies of their metric properties were identified by systematic review: the Chronic Heart Failure Assessment Tool, the Cardiac Health Profile congestive heart failure, the Chronic Heart Failure Questionnaire (CHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Left Ventricular Disease Questionnaire (LVDQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Quality of Life in Severe Heart Failure Questionnaire. Each instrument was assessed by four experts using a standardized tool for evaluating patient-reported outcomes (EMPRO; scores from 0 to 100). Four questionnaires were given adequate scores (median >50) for the attribute “conceptual model.” The LVDQ had the highest rated median for “reliability” (72.8). The CHFQ, the KCCQ, and the MLHFQ all got reasonable scores for “validity” (from 54.4 to 76.4). The reviewers rated the KCCQ the highest in terms of “sensitivity to change” (median 94.4). Only the CHFQ (50.0) and the KCCQ (72.2) received adequate scores for the “interpretability” attribute. The most highly rated instruments based on the overall EMPRO score were the KCCQ (64.4) and the MLHFQ (60.7), followed by the CHFQ (59.2). Based on the first systematic and reliable expert-based evaluation of available HF-specific HRQL questionnaires, the evidence seems to support the choice of the KCCQ, the MLHFQ, and the CHFQ over the others, which require further research on metric properties.

Assessing quality of life in patients with prostate cancer: a systematic and standardized comparison of available instruments

PurposeThe objective was to obtain a standardized evaluation of available prostate cancer-specific quality of life instruments used in patients with early-stage disease.MethodsWe carried out systematic literature reviews in the PubMed database to identify manuscripts which contained information regarding either the development process or metric properties of prostate cancer-specific quality of life instruments. Each instrument was evaluated by two experts, independently, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0–100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden and alternative forms.ResultsEight instruments and 57 manuscripts (2–15 per instrument) were identified. The Expanded Prostate Cancer Index Composite (EPIC) was the best rated (overall EMPRO score 83.1 points). Good results were also obtained by University of California Los Angeles-Prostate Cancer Index (UCLA-PCI), Patient-Oriented Prostate Utility Scale (PORPUS) and Prostate Cancer Quality of Life Instrument (PC-QoL) with 77.3, 70.5 and 64.8 points, respectively. These four instruments passed with distinction the validity and responsiveness evaluation. Insufficient reliability results were observed for UCLA-PCI and PORPUS.ConclusionsCurrent evidence supports the choice of EPIC, PORPUS or PC-QoL. Attribute-specific EMPRO results facilitate selecting the adequate instrument for every purpose. For longitudinal studies or clinical trials, where responsiveness is the priority, EPIC or PC-QoL should be considered. We recommend the PORPUS for economic evaluations because it allows cost-utility analysis, and EPIC short versions to minimize administration burden.

Validation of the Spanish Version of the Minnesota Living With Heart Failure Questionnaire

INTRODUCTION AND OBJECTIVES The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is the most commonly used instrument for evaluating quality of life in patients with heart failure. It comprises 21 items and two dimensions: the physical and the emotional. The aim of this study was to assess the psychometric properties of the Spanish version of the MLHFQ. METHODS The MLHFQ and the 36-item short form (SF-36) questionnaire were administered one and two months after discharge to 677 patients who had been hospitalized for heart failure. Patients were classified as either stable (n=245) or unstable (n=103) on the basis of New York Heart Association (NYHA) functional class and three other functional capacity variables. Reliability was evaluated using measures of internal consistency (Cronbachs alpha) and reproducibility (the intraclass correlation coefficient [ICC]). Validity was assessed by looking at the scores by NYHA class, and at correlations between scores on MLHFQ and SF-36 dimensions. Responsiveness to change was evaluated using the effect size. RESULTS Cronbachs alpha was > OR =0.8 for the three MLHFQ scores, and the ICC was also large (0.74-0.83). In addition, MLHFQ scores varied significantly with functional class (P< .001), and there were intermediate-to-high correlations with the assumed corresponding SF-36 dimensions (0.74-0.52). The observed effect sizes were small or intermediate (0.09-0.44). CONCLUSIONS The Spanish version of the MLHFQ demonstrated adequate metric properties, comparable to the original. These results support the use of the MLHFQ in Spanish heart failure patients, although it would be advisable to re-evaluate its responsiveness to change.