Evaluation of reliability and validity of Spanish version of the end-stage renal disease symptom checklist-transplantation module.

BACKGROUND: Although health-related quality of life (HRQoL) of patients with a renal transplantation is an important variable, it has received little attention and only a few Spanish validated measurement instruments are available. The aim of this study was to assess the psychometric properties of the Spanish version of the End Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL), a specific questionnaire for measuring HRQoL of kidney transplant patients. METHODS: This prospective study to validate the ESRD-SCL included 307 patients who received a first kidney transplant. Patients filled out the ESRD-SCL, the EuroQol-5D and the Short Form-36 Health Survey at pretransplant, after 3 months, 6 months, and 1 year of follow-up. A complete set of sociodemographic and clinical data was also collected. RESULTS: Mean age of patients was 51.6 years (SD+/-12) and 59.2% were men. A total of 24% had suffered initial allograft dysfunction and 18% had acute rejection. A six-dimensional factorial structure could be discerned. These dimensions were different from the original questionnaire and explained 56.07% of the variance. Internal consistency was good (Cronbach alpha = 0.91 for the overall score and 0.60-0.86 for dimensions). A statistically significant moderate correlation was observed between the Short Form-36 and EuroQol-5D with the ESRD-SCL dimensions and with some of the clinical and sociodemographic variables. CONCLUSIONS: The Spanish version of the ESRD-SCL is a useful, user-friendly instrument for measuring the HRQoL related to the side effects on immunosuppression treatment of renal transplant patients more accurately.

[Estimating utility values for health status using the Spanish version of the SF-36. Validity of the SF-6D index vs EQ-5D]. / Estimación de un índice de utilidad mediante el uso de la versión española del Cuestionario de Salud SF-36: validez del índice SF-6D frente al EQ-5D.

BACKGROUND AND OBJECTIVE: A new utility index derived of the SF-36, the SF-6D, was recently developed and has been compared with other utility measures. The objective was to validate this index in the Spanish version of SF-36 with respect to the EQ-5D. METHOD: 1,843 complete measures of the SF-36 and the EQ-5D from 1,283 patients who received a solid organ transplant were collected. SF-6D values were calculated using the model proposed by its creator and without tariff values (not weighted). EQ-5D values were calculated using Spanish visual analog scale tariff (VAS-t), the time-trade off tariff (TTO-t) and also without tariff values (not weighted). Spearman correlation coefficients were calculated between SF-6D and EQ-5D values. RESULTS: Mean value (standard deviation) of SF-6D was 0.67 (0.15), of VAS-t, 0.69 (0.24) and of TTO-t, 0.70 (0.32). SF-6D values had moderate correlation with VAS-t (r = 0.734) and TTO-t (r = 0.731) (both p < 0.001). The not weighted SF-6D had a high correlation with the weighted version (r = 0.969, p < 0.001), and moderate with the VAS-t (r = 0.754), TTO-t (r = 0.750) and no weighted EQ-5D (r = 0.784) (p < 0.001). CONCLUSIONS: The SF-6D index derived from the Spanish version of SF-36 seem to be a valid utility index to be used with the SF-36 databases from studies made in Spain.

Differences in health-related quality of life between elderly and younger patients on hemodialysis.

BACKGROUND: It has been demonstrated that elderly patients have a great capacity of adaptation to renal replacement therapy (RRT). The aim of this study was to assess the health-related quality of life (HRQoL) of a cohort of patients at 3 and 12 months after the start of hemodialysis, searching for differences between elderly (aged>or=65 years) and younger (aged <65 years) patients. METHODS: This was a longitudinal prospective study of 93 patients starting RRT. HRQoL was assessed using the SF-36 health survey and the physical symptom dimension of the Kidney Disease Questionnaire (KDQ) at 3 and 12 months from the start of RRT. Physical component summary (PCS), mental component summary (MCS) and standardized scores, in which a lower score indicated lower HRQoL, by age and sex were obtained. RESULTS: Mean (SD) age was 66 years (12.26 years). At 3 months, differences between younger patients and elderly ones were statistically significant in the general health dimension, and at 12 months in physical functioning, role physical, general health dimensions and PCS, indicating less loss of HRQoL in elderly patients. At 3 months it was found that the functional state measured on the Karnofsky scale was independently associated with PCS (p=0.003), and hematocrit to MCS (p=0.036). At 1 year, PCS was independently associated with age (p=0.043) and Karnofsky score (p=0.039). CONCLUSIONS: Using scores standardized by age and sex, elderly patients had less loss of HRQoL in the physical aspects, than younger patients at 1 year from the start of hemodialysis.

Spanish validation of the "kidney transplant questionnaire": a useful instrument for assessing health related quality of life in kidney transplant patients.

BACKGROUND: There is a growing interest in the evaluation of Health Related Quality of Life (HRQoL) among patients undergoing Renal Replacement Therapy. In Spain, no specific questionnaire exists for kidney transplant patients. Here we present the Spanish validation of the first specific HRQoL assessment tool: the kidney transplant questionnaire (KTQ). METHODS: Prospective study of 31 patients on transplant waiting list who received the first kidney. Patients were evaluated before transplant and after 1, 3, 6 and 12 months, using the KTQ and the SF-36 Health Survey. Feasibility, validity, reliability, and sensibility to change were evaluated. RESULTS: Mean time of administration of the KTQ was 12 minutes. Correlation coefficients among KTQ dimensions range between 0.32 and 0.72. Correlation coefficients of KTQ dimensions with SF-36 PCS were low (r<0.4), and with SF-36 MCS were moderate-high (r>0.4) except for Physical Symptom dimension (r = 0.33). Cronbach's Alpha was satisfactory for all KTQ dimensions (Physical Symptoms = 0.80; Fatigue = 0.93; Uncertainty/Fear = 0.81; Emotional= 0.90) except Appearance (0.69). Intraclass correlation coefficients ranged between 0.63 and 0.85, similar to those of the original KTQ version. CONCLUSIONS: Results of validation study show that feasibility, validity, reliability and sensibility to change of the Spanish version of the KTQ are similar to those of the original version.

Health-related quality of life of family caregivers of dialysis patients.

BACKGROUND: This study aimed to evaluate the health-related quality of life (HRQOL) and burden on family caregivers of chronic dialysis patients and to analyze which factors were associated with it. METHODS: A cross-sectional multicentric study was carried out with 221 patient/caregiver pairs. General population Short Form 36 (SF-36) norms were used to estimate gender and age standardized physical component summary (PCS) and mental component summary (MCS) scores. The Duke-UNC Functional Social Support Questionnaire (FSS), the Zarit Burden Interview (ZBI), and sociodemographic and clinical data were also collected. RESULTS: The PCS and MCS of caregivers were slightly worse than that of the Spanish population. Multiple regression analysis showed that: (1) lower PCS was associated with younger age and higher ZBI of the caregiver (R2=0.15); (2) lower MCS was associated with higher ZBI and lower FSS of the caregiver, and lower MCS of the patient (R2=0.29); (3) higher ZBI was associated with lower FSS, PCS and MCS of the caregiver, and to older age and lower PCS and MCS of the patient (R2=0.49). Of caregivers 28.3% had a MCS < or = 42; logistic regression analysis showed that a MCS < or = 42 was associated to higher ZBI and lower FSS scores (p<0.001). CONCLUSIONS: The HRQOL of dialysis patient family caregivers is slightly worse than that of the Spanish population of the same age and gender. Younger family members, who are the primary carers of older dialysis patients with poor HRQOL, experienced a higher burden, had a worse HRQOL and had a higher risk of clinical depression; this was worse if low social support was perceived.

Different evaluations of the health related quality of life in dialysis patients.

BACKGROUND: Sometimes patients on dialysis treatment cannot express their health-related quality of life (HRQoL); and therefore, it is necessary to use the assessment made by their carers. The purpose of this study was to evaluate the agreement between dialysis patients' HRQoL and the assessment made by their carers, and to investigate which variables were associated with the differences found. METHODS: Two hundred and twenty-two pairs of patients and carers were selected from 14 dialysis units. Patients' HRQoL was evaluated by the patients themselves and by their family carer (FAM), nurse (NUR) and physician (PH) using the Karnofsky scale (KS) and the EuroQOL5D (EQ5D) scale. Patients and their family carers answered the Medical Outcome Survey 36-Item Short Form Health Survey (SF-36), and the family carers answered the Zarit burden interview. Physicians scored the patients' comorbidity index and nurses evaluated the Barthel index (BI). RESULTS: The intraclass correlation coefficients (ICC) between the ratings provided by patients and their carers were: KS: 0.80(FAM), 0.76(NUR) and 0.62(PH); EQ5D: 0.42(FAM), 0.48(NUR) and 0.29(PH). The agreement between the EQ5D dimension scores varied from moderate for mobility and self-care to insignificant for pain and anxiety/depression. The variables associated to the size of the differences found were the Zarit burden interview score and the mental component score (MCS) (SF-36) of the carer, the physical component score (PCS) (SF-36), the BI score and patient comorbidity, and the physician's age and experience. CONCLUSIONS: Family carers and health care providers of dialysis patients are reasonably aware of the patient's level of function and well being and can be useful sources of proxy HRQoL information. Nevertheless, discrepancies can occur, depending in part on the different characteristics of patients and their caregivers.

The utility of a specific measure for heart transplant patients: reliability and validity of the Kansas City Cardiomyopathy Questionnaire.

BACKGROUND: Health-Related Quality of Life of patients with heart transplantation is an important variable; however, it has received little attention so far, and only two Spanish validated measurement instruments are available. The aim of our study was to validate the Spanish version of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in heart transplant patients. METHODS: A prospective study was performed in 186 patients awaiting heart transplantation in nine transplant hospitals. Hundred transplant recipients filled out the KCCQ, the Euroqol 5-D (EQ5D), and the Short Form-36 (SF-36) Health Survey at pretransplant, after 3 months, 6 months, and 1 year of follow-up. A complete set of sociodemographic and clinical data were also collected. The validity, reliability, sensitivity to change, and effect size were studied. Two questionnaires, the SF-36 and EQ5D, were used to evaluate the validity. RESULTS: Mean age of patients was 56.0 years, and 80.5% were men. Twenty-six percent had acute rejection. A five-dimensional factorial structure could be discerned. The questionnaire presented a Cronbach's alpha coefficient of more than 0.7. Correlations between the KCCQ and the other questionnaires and clinical variables were satisfactory. CONCLUSIONS: The KCCQ features adequate psychometric properties. The KCCQ offers several advantages over other questionnaires because it quantifies symptoms (frequency, severity, and stability) and it is much more sensitive to change, even when compared with the SF-36. The specific questionnaire for heart transplant patients is a useful and user-friendly instrument for measuring the Health-Related Quality of Life related to functional status, quality of life, and social limitation more accurately.

Mental health at the third month of haemodialysis as a predictor of short-term survival.

BACKGROUND: The aim of this study was to evaluate the survival of patients initiating haemodialysis (HD), and to analyse whether low health-related quality of life (HRQoL) levels are predictors of mortality in the short-term, controlling certain variables that had been shown in other studies to have a bearing on survival, and using scores, standardized for age and sex, of the HRQoL measurement tool employed. METHODS: This is a multicentric prospective study of all patients on HD in all the dialysis units in Asturias, a region with a little over one million inhabitants, from 1 January 2001 to 30 September 2002. A total of 199 patients initiated HD in our region and survived the first 3 months. Of these, 137 patients who remained on HD for at least 3 months had complete responses on HRQoL measures. RESULTS: It was observed that adjusted relative risk (RR) of death increased by 5% for each year of age increase (RR=1.05, 95% CI 1.01-1.09: P=0.006); in the same way, for each increase in the Mental Component Summary (MCS) score, the adjusted RR of death diminished by 4% (RR=0.96, 95% CI 0.94-0.99; P=0.006). CONCLUSION: Mental health has been shown to be a factor independently associated with mortality; as the MCS score worsens the adjusted RR of death of a patient on HD increases.

Estimación de un índice de utilidad mediante el uso de la versión española del Cuestionario de Salud SF-36: validez del índice SF-6D frente al EQ-5D / Estimating utility values for health status using the Spanish version of the SF-36. Validity of the SF-6D index vs EQ-5D

Fundamento y objetivo: Recientemente se ha desarrollado un nuevo índice de utilidad derivado del SF-36, el SF-6D, que ha sido comparado con otras medidas similares. El objetivo del presente estudio ha sido validar el SF-6D, obtenido a partir de la versión española del SF-36, respecto al EQ-5D. Método: Se disponía de 1.843 medidas del SF-36 y el EQ-5D de 1.283 pacientes que habían recibido un trasplante de órgano sólido. Se calculó el SF-6D siguiendo el modelo propuesto por su creador y sin las tarifas (sin pesos). El EQ-5D se calculó con las 2 tarifas españolas, a partir de la escala visual analógica (t-EVA), por la técnica de equivalencia temporal (t-ET), y también sin pesos. Se calcularon los coeficientes de correlación de Spearman entre los diferentes valores del SF-6D y el EQ-5D. Resultados: La media (desviación estándar) del SF-6D fue de 0,67 (0,15), la de la t-EVA de 0,69 (0,24) y la de la t-ET de 0,70 (0,32). El SF-6D mostró correlación moderada con la t-EVA (r = 0,734) y con la t-ET (r = 0,731) (p , 0,001 para ambas). La versión sin pesos del SF-6D mostró una correlación elevada con el SF-6D con pesos (r = 0,969; p , 0,001) y moderada con la t-EVA (r = 0,754), t-ET (r = 0,750) y versión sin pesos del EQ-5D (r = 0,784) (p , 0,001 para todas). Conclusiones: El SF-6D derivado de la versión española del SF-36 parece ser una medida de utilidad válida para su uso en bases de datos con el SF-36 de estudios realizados en España

Background and objective: A new utility index derived of the SF-36, the SF-6D, was recently developed and has been compared with other utility measures. The objective was to validate this index in the Spanish version of SF-36 with respect to the EQ-5D. Method: 1,843 complete measures of the SF-36 and the EQ-5D from 1,283 patients who received a solid organ transplant were collected. SF-6D values were calculated using the model proposed by its creator and without tariff values (not weighted). EQ-5D values were calculated using Spanish visual analog scale tariff (VAS-t), the time-trade off tariff (TTO-t) and also without tariff values (not weighted). Spearman correlation coefficients were calculated between SF-6D and EQ-5D values. Results: Mean value (standard deviation) of SF-6D was 0.67 (0.15), of VAS-t, 0.69 (0.24) and of TTO-t, 0.70 (0.32). SF-6D values had moderate correlation with VAS-t (r = 0.734) and TTO-t (r = 0.731) (both p , 0.001). The not weighted SF-6D had a high correlation with the weighted version (r = 0.969, p , 0.001), and moderate with the VAS-t (r = 0.754), TTO-t (r = 0.750) and no weighted EQ-5D (r = 0.784) (p , 0.001). Conclusions: The SF-6D index derived from the Spanish version of SF-36 seem to be a valid utility index to be used with the SF-36 databases from studies made in Spain