BACKGROUND: Economic valuations of health care programs often require using patients as subjects, implying that research methodology should conform to the surrounding social, cultural and ethical context. The significance of patients' opinions in health care decisions has been well defined but in Greece, and perhaps elsewhere, clinicians remain skeptical. The purpose of this study was to investigate, for the first time in Greece, the feasibility of measuring preference-based health-state utilities and willingness to pay and to determine the context-based adaptations required to overcome inherent elicitation problems.
METHODS: A survey including a time trade-off (TTO), a standard gamble (SG), and two willingness-to-pay (WTP) questions was self-administered to a homogenous group of 606 end stage renal disease patients in 24 dialysis facilities throughout Greece and the overall response rate was 78.5%. Typical elicitation methods were adapted to overcome methodological problems such as subjective life expectancy and question framing. Spearman's correlation coefficients were calculated between utilities and WTP and parametric tests (independent samples t-test and ANOVA) examined score differences as a result of demographic and clinical factors.
RESULTS: Mean health-state utilities were 72.56 (TTO) and 91.06 (SG) and these were statistically significantly different (P < 0.0005). Significant correlations, in the expected directions, were observed between TTO - SG, TTO - WTP and SG - WTP (P < 0.01). High ceiling effects were observed in the TTO and SG methods indicating patients' adversity to risk and unwillingness to trade-off life years. Higher WTP was observed from younger patients (P < 0.0005), males (P < 0.05), higher education levels (P < 0.01), single (P < 0.0005) and employed (P < 0.005).
CONCLUSION: This study demonstrated, to a fair extent, that adapting research methods to context-based particularities does not necessarily compromise results and should be considered in situations where standard methods cannot be applied. On the other hand, it is emphasized that the results from this study are preliminary and should be interpreted cautiously until further research demonstrates the practicality, reliability and validity of alternative measurement approaches.
OBJECTIVES: To survey of the structure, processes and organisation of renal satellite units (RSUs) in England and Wales (Phase 1), and to compare the effectiveness, acceptability, accessibility and economic impact of chronic haemodialysis performed in RSUs compared to main renal units (MRUs) (Phase 2).
DATA SOURCES: Phase 1: all renal satellite units in England and Wales. Phase 2: haemodialysis patients in a representative sample (based on geography, site, private--public ownership, medical input) of 12 RSUs and their MRUs.
REVIEW METHODS: Phase 1 consisted of a questionnaire survey. Semi-structured interviews were held in a representative sample of 24 RSUs with the senior clinician, senior nurse and manager. Phase 2 consisted of a cross-sectional comparison of patients in these RSUs and patients in the parent MRUs deemed suitable for satellite care by senior staff. Clinical information was obtained from medical notes and unit computer systems. Generic and disease specific health-related quality of life (HRQoL) measures were used. Co-morbidity was assessed by the Wright/Khan Index, the Lister/Chandna score, the Modified Charlson Index, and the Karnofsky Performance Score. Statistical analyses compared RSU versus MRU patients and took account of the paired and clustered nature of the data.
RESULTS: In Phase 1, responses were received from 74/80 (93%) of RSUs; 2600 patients were being treated in these RSUs. The interviews were generally positive about the impact of RSUs in terms of improved accessibility and a better environment for chronic haemodialysis (HD) patients, and in expanding renal replacement therapy patients (RRT) capacity. In Phase 2, some 82% of eligible patients took part, 394 patients in the 12 RSUs and 342 in the parent MRUs. The response rate was similar in both groups. There were no significant differences in clinical processes of care. Most clinical outcomes were similar, especially after pooled analysis, although a few parameters were statistically significantly different -- notably the proportion achieving Renal Association Standards for adequacy of dialysis as measured by the urea reduction ratio (URR) was higher in the RSU patients. Patient-specific quality of life did not differ except on the patient satisfaction questions from the KDQOL, which were scored higher by the RSU sample. Strength of preference for health status on and off dialysis was very similar between the groups, as were EQ-5D utilities. Major adverse events were not common in the RSU patients, although there were many hypotensive episodes on HD, a proportion of which affected the duration of the HD session. Of the costs measured, the only difference that was statistically significant was for District Nurse visits. Of particular note was that despite the MRU group having a higher proportion of patients hospitalised, this did not translate into a statistically significant budgetary impact in terms of the total cost per patient of hospitalisations or mean cost per patient per hospitalisation.
CONCLUSIONS: This study has shown that RSUs are an effective alternative to MRU HD for a wide spectrum of patients. They improve geographic access for more dispersed areas and reduce patients' travel time, and are generally more acceptable to patients on several criteria. There does not seem to be an adverse impact of care in the RSUs although comparative long-term prospective data are lacking. The evidence suggests that satellite development could be successfully expanded; not all MRUs have any satellites and many have only a few. No single RSU model can be recommended but key factors would include local geography, the likely catchment population and the type of patients to be treated. There is a need for more basic budgetary information linking activity and expenditure to be available and more transparent, to perform at least an insightful top-down costing of the two care settings. Other areas suggested for further research include: a comparison of adverse events occurring in MRUs and RSUs with longer duration and larger numbers to identify more severe events, along with the more research into the scope for preventing such events, and a study into the patients deemed ineligible for satellite care. International comparisons of satellite care would also be useful.
OBJETIVO: El objetivo de este estudio fue evaluar la calidad de vida relacionada con la salud (CVRS) en pacientes con insuficiencia renal que habían recibido un trasplante renal en comparación con los que recibieron hemodiálisis, diálisis peritoneal o estaban a la espera de comenzar la diálisis.
Material y métodos: El estudio se llevó a cabo en el Hospital Universitario de Gales, Cardiff. CVRS se midió utilizando el EQ-5D, SF-36 y el Riñón Enfermedad del cuestionario de calidad de vida (KDQOL). Los pacientes con insuficiencia renal se identificaron en la base de datos departamental unidad renal y fueron encuestados mediante un cuestionario postal o durante su tratamiento.
Resultados: De 1.251 personas encuestadas, se recibieron 416 vueltas válidas, una tasa de respuesta del 33%. Para los pacientes sometidos a trasplante renal la media EQ-5Dindex era 0.712 (SD 0.272), significativamente más altos que los de los otros grupos de tratamiento (hemodiálisis significa = 0,443 (SD 317), p <0,001; diálisis peritoneal significa = 0,569 (SD 329), p <0,001). Esta diferencia se mantuvo después de controlar por edad y comorbilidad. Con la excepción del dolor, el SF-36 mostraron puntuaciones significativamente más altas en todos los dominios para los pacientes de trasplante en comparación con los dos grupos de diálisis. Desde el KDQOL hubo resultados significativamente más bajos en comparación con los pacientes de trasplante de los dos grupos de pacientes en diálisis de los efectos y la carga de la enfermedad renal y los síntomas generales y problemas. Sin embargo, los resultados generales de salud fueron significativamente mayores en los pacientes en diálisis en comparación con los pacientes de trasplantes.
CONCLUSIÓN: La insuficiencia renal tiene un alto costo en términos de calidad relacionada con la salud de la vida. Había una gran diferencia entre los pacientes que han recibido un injerto después del trasplante de riñón funcionamiento en comparación con los métodos alternativos de terapia de reemplazo renal, es decir, diálisis peritoneal y hemodiálisis. El trasplante renal debe ser el tratamiento de elección, y debe hacerse todo lo posible para aumentar la disponibilidad de riñones para trasplante.
BACKGROUND: Quality of life (QOL) assessment in patients on chronic haemodialysis (HD) or peritoneal dialysis (PD) has only rarely been carried out with the generic Euroqol-5D questionnaire.
METHODS: All chronic HD and PD patients in the 19 centres of western Switzerland were requested to fill in the validated Euroqol-5D generic QOL questionnaire, assessing health status in five dimensions and on a visual analogue scale, allowing computation of a predicted QOL value, to be compared with the value measured on the visual analogue scale.
RESULTS: Of the 558 questionnaires distributed to chronic HD patients, 455 were returned (response rate 82%). Fifty of 64 PD patients (78%) returned the questionnaire. The two groups were similar in age, gender and duration of dialysis treatment. Mean QOL was rated at 60+/-18% for HD and 61+/-19% for PD, for a mean predicted QOL value of 62+/-30 and 58+/-32% respectively. Results of the five dimensions were similar in both groups, except for a greater restriction in usual activities for PD patients (P = 0.007). The highest scores were recorded for self-care, with 71% HD and 74% PD patients reporting no limitation, and the lowest scores for usual activities, with 14% HD and 23% PD patients reporting severe limitation. Experiencing pain/discomfort (for HD and PD) or anxiety/depression (for PD) had the highest impact on QOL.
CONCLUSIONS: QOL was equally diminished in HD and PD patients. The questionnaire was well accepted and performed well. Improvement could be achievable in both groups if pain/discomfort and anxiety/depression could be more effectively treated.
BACKGROUND: How dialysis patients feel about their treatment may influence how they respond to information suggesting that survival is better with a higher dose or different treatment modality. We assessed the strength of dialysis patients' preferences for their current treatment modality versus other modalities, how differences in survival between modalities and doses could influence preferences, and whether preferences differ by patient characteristics.
METHODS: We measured preference values for current health on dialysis therapy and for standardized descriptions of dialysis modalities and doses by using a sample of dialysis patients in Maryland and Massachusetts and a time trade-off technique scaled between 0 (death) and 1 (perfect health).
RESULTS: We interviewed 109 patients on hemodialysis therapy, 57 patients on continuous ambulatory peritoneal dialysis (CAPD), and 22 patients on continuous cycling peritoneal dialysis (CCPD). Hemodialysis, CAPD, and CCPD patients had similar preference values for current health (mean, 0.69, 0.74, and 0.70, respectively; P > 0.1) and lower preference values for alternative modalities (eg, mean of 0.55 assigned to CAPD by hemodialysis patients). More than 75% of patients would choose a high dose over a lower dose of dialysis if it increased length of survival by 20%, but more than 30% would not switch modality, even if it increased survival by 100%. The only characteristic associated with a difference in preference values was depression, with weaker preferences among those with mild to moderate depressive mood.
CONCLUSION: Dialysis patients have strong preferences for their current modality and are more likely to accept a higher dose of dialysis than switch modality to increase survival. Physicians should talk with patients about the modality and dose they prefer because preferences cannot be predicted by patient characteristics.
ANTECEDENTES: Los pacientes con enfermedad renal en etapa terminal (ESRD) tienen deficiencias significativas en la calidad relacionada con la salud de la vida (CVRS). En parte, esto es debido a la intrusión del tratamiento (hemodiálisis o diálisis peritoneal) que se requiere. No está claro si la hemodiálisis o diálisis peritoneal se asocia con una mayor CVRS.
Métodos: 192 pacientes prevalentes que el tratamiento auto-seleccionados con hemodiálisis (ya sea en el centro o en el hogar vía satélite / hemodiálisis autocuidado) o diálisis peritoneal fueron estudiados para determinar si el tratamiento con hemodiálisis o diálisis peritoneal se asocia con una mayor CVRS. Se evaluó demográfica, el laboratorio y la información clínica (incluyendo la presencia de comorbilidades utilizando el índice de comorbilidad de Charlson) al inicio del estudio. El resultado de interés fue la CVRS, que se midió utilizando el Riñón Enfermedad Calidad de Vida-Short Form (KDQOL-SF), el Short-Form 36 (SF-36) y el EuroQol EQ-5D al inicio del estudio y después de 6 y 12 meses de seguimiento.
RESULTADOS: No hubo diferencias significativas en la CVRS calificaciones de las SF-36, el EQ-5D y 9 de 11 dimensiones KDQOL para los pacientes tratados con hemodiálisis o diálisis peritoneal al inicio del estudio. Como era de esperar, la CVRS fue significativamente menor en los pacientes que tenían enfermedad más comorbilidad, la asistencia necesaria a su cuidado diario, y para los pacientes con una educación inferior a 12 grados. Después de controlar el efecto de otras variables importantes, la CVRS (según lo medido por el EQ-5D visual analógica o puntuaciones del índice) no difirió entre los pacientes en hemodiálisis y diálisis peritoneal. CVRS se mantuvo estable en el tiempo, tanto para los pacientes que comenzaron en hemodiálisis o diálisis peritoneal.
CONCLUSIONES: No hay diferencia significativa en la CVRS de los pacientes con ESRD prevalentes tratados con hemodiálisis o diálisis peritoneal. Será importante para determinar si este hallazgo es cierto para los pacientes incidentes tratados con hemodiálisis o diálisis peritoneal.
BACKGROUND: Studies have shown improved quality of life for hemodialysis (HD) patients after changing from conventional thrice-weekly HD treatment to more frequent HD.
METHODS: In the London Daily/Nocturnal Hemodialysis Study, 23 patients (11 patients, short daily HD; 12 patients, long nocturnal HD) were compared with 22 conventional thrice-weekly HD patients serving as controls. All patients completed 3 sets of quality-of-life assessment tools: (1) a locally developed renal disease-specific questionnaire that assessed dialysis symptoms, uremic symptoms, psychosocial stress, and social-leisure activity; (2) the generic Medical Outcomes Survey 36-Item Short Form (SF-36); and (3) the global Health Utilities Index (HUI). As a supplement to the HUI, a subset of patients was asked to complete the Time Trade-Off assessment.
RESULTS: Overall, the reduction in symptoms shows better fluid management because quotidian HD patients reported experiencing fewer and less severe cramping during dialysis, fewer headaches, less hypotension, fewer episodes of dizziness, decreased fluid restrictions, fewer blood pressure problems, decreased interdialytic weight gains, fewer episodes of shortness of breath, and a reduction in the sensation of easily feeling cold. HUI results showed that quotidian HD patients maintained functionality throughout the study period, whereas control patients showed a significant loss. Given the choice, all patients chose to remain on quotidian HD therapy after switching from conventional HD therapy. The Time Trade-Off analysis indicated that study patients were willing to trade far less time on quotidian HD therapy and much more time on conventional HD therapy in exchange for "perfect" health.
CONCLUSION: As more studies focus on improved patient outcomes and appropriate funding mechanisms are established, more frequent home HD treatment should become a standard treatment option for patients with end-stage renal disease.
BACKGROUND: Renal transplantation is frequently considered superior to other renal replacement therapy in terms of survival and quality-of-life outcome. In this study, it was examined whether physicians and nurses have accurate perceptions of health status after renal transplantation (RTX) and whether renal transplant candidates have realistic expectations about posttransplant quality of life.
METHODS: A comparative descriptive design was used for the comparison of physicians' and nurses' perceived and patients' expected and actual health status after RTX. Health status perceptions were measured by means of the EQ-5D self-report questionnaire. RTX candidates (n=107) were followed longitudinally from November 1999 until July 2001. Transplant patients (n=29) were surveyed 14 days and 4, 8, and 12 months after discharge from hospital. All physicians and nurses (n=123) had regular contact with dialysis or RTX patients.
RESULTS: Physicians' and nurses' perceptions of health status after RTX were significantly lower than patients' expectations. Transplant nurses' and physicians' valuations were closer to patients' actual health status after transplantation than valuations of nurses on the dialysis or nephrology ward or at the outpatient clinic.
CONCLUSIONS: RTX candidates frequently have higher expectations about their quality of life after transplantation than physicians and nurses who have regular contact with renal transplant patients. Physicians' and nurses' perceptions are closer to the actual health state after transplantation than patients' expectations. Thus, physicians and nurses are a reliable source of information for patients about the health state they can expect after transplantation.
ANTECEDENTES: Inicio hemodiálisis nocturna es una forma intensiva de la hemodiálisis, donde los pacientes realizan sus tratamientos en casa durante unas 7 horas aproximadamente 6 noches a la semana. En comparación con en centro de hemodiálisis convencional, hemodiálisis nocturna en casa se ha demostrado que mejora los parámetros fisiológicos y reducir los costos de atención de la salud; sin embargo, los efectos sobre la calidad de vida y coste utilidad son menos claras. La hipótesis de que los individuos que realizan hemodiálisis nocturna en casa tendrían una mayor calidad de vida y la utilidad costo superior a los pacientes de hemodiálisis en el centro.
MÉTODOS: Inicio pacientes en hemodiálisis nocturna y un grupo demográficamente similar de pacientes de hemodiálisis en el centro de un hospital sin un programa de hemodiálisis en el hogar fueron sometidos a entrevistas asistidas por ordenador para evaluar su puntuación de utilidad para la salud actual apuesta por el método estándar.
RESULTADOS: Diecinueve hemodiálisis en el hospital y 24 pacientes de hemodiálisis nocturna en casa fueron entrevistados. Los costes medios anuales para el hogar hemodiálisis nocturna eran unos 10.000 dólares más baja para el hogar hemodiálisis nocturna (55.139 dólares +/- 7.651 dólares para el hogar nocturna hemodiálisis vs. 66.367 dólares +/- 17.502 dólares para hemodiálisis en el centro, P = 0,03). Inicio hemodiálisis nocturna se asoció con una puntuación superior a la utilidad de hemodiálisis en el hospital (0,77 +/- 0,23 versus 0,53 +/- 0,35, P = 0,03). La utilidad de costos para el hogar hemodiálisis nocturna era 71.443 dólares / año de vida ajustado por calidad (AVAC), mientras que para hemodiálisis en el hospital fue 125.845 dólares / AVAC. Inicio hemodiálisis nocturna fue la estrategia dominante, con una relación coste-efectividad incremental (ICER) de -45.932 dólares. El IC del 95% para el ICER y 2500 iteraciones de arranque del ICER todos cayeron por debajo del techo de costo-efectividad de 50.000 dólares. El beneficio monetario neto de casa hemodiálisis nocturna varió de 11.227 dólares a 35.669 dólares.
CONCLUSIÓN: Inicio hemodiálisis nocturna se asocia con una mayor calidad de vida y una utilidad de costo superior en comparación con hemodiálisis en el centro.
Tacrolimus is increasingly used as a baseline immunosuppressant after renal transplantation. This multicentre study assessed health-related quality of life and symptom experience in renal transplant patients on tacrolimus-based therapy, using the SF-36 and Euroqol 5 dimensions (EQ-5D) and the 'modified transplant symptom occurrence and symptom distress scale', respectively. Symptoms of depression were assessed with the short form of the Beck Depression Inventory and physical activity with the Baecke questionnaire. Overall, 350 patients with a median post-transplant status of 16.7 months were enrolled. Results revealed that patients experienced lower SF-36 scores than the general population, except in terms of bodily pain. Univariate and multivariate analyses demonstrated that a higher degree of depressive symptoms and female gender were consistently related to a health status perceived as being worse and a higher rate of symptom experience. These findings are in accordance with previous quality-of-life reports that assessed patients under various immunosuppressive therapies. Therefore, interventions, including the screening and treatment for depression and the addressing of gender-specific issues, can enhance quality of life.
Economic valuations of health care programs often require using patients as subjects, implying that research methodology should conform to the surrounding social, cultural and ethical context. The significance of patients' opinions in health care decisions has been well defined but in Greece, and perhaps elsewhere, clinicians remain skeptical. The purpose of this study was to investigate, for the first time in Greece, the feasibility of measuring preference-based health-state utilities and willingness to pay and to determine the context-based adaptations required to overcome inherent elicitation problems.
METHODS:
A survey including a time trade-off (TTO), a standard gamble (SG), and two willingness-to-pay (WTP) questions was self-administered to a homogenous group of 606 end stage renal disease patients in 24 dialysis facilities throughout Greece and the overall response rate was 78.5%. Typical elicitation methods were adapted to overcome methodological problems such as subjective life expectancy and question framing. Spearman's correlation coefficients were calculated between utilities and WTP and parametric tests (independent samples t-test and ANOVA) examined score differences as a result of demographic and clinical factors.
RESULTS:
Mean health-state utilities were 72.56 (TTO) and 91.06 (SG) and these were statistically significantly different (P < 0.0005). Significant correlations, in the expected directions, were observed between TTO - SG, TTO - WTP and SG - WTP (P < 0.01). High ceiling effects were observed in the TTO and SG methods indicating patients' adversity to risk and unwillingness to trade-off life years. Higher WTP was observed from younger patients (P < 0.0005), males (P < 0.05), higher education levels (P < 0.01), single (P < 0.0005) and employed (P < 0.005).
CONCLUSION:
This study demonstrated, to a fair extent, that adapting research methods to context-based particularities does not necessarily compromise results and should be considered in situations where standard methods cannot be applied. On the other hand, it is emphasized that the results from this study are preliminary and should be interpreted cautiously until further research demonstrates the practicality, reliability and validity of alternative measurement approaches.
