Jesús Cuervo

Cost analysis of the Spanish renal replacement therapy programme

BACKGROUND A cost analysis of the Spanish Renal Replacement Therapy (RRT) programme in the year 2010, for end-stage renal disease (ESRD) patients, was performed from the perspective of the Public Administration. METHODS The costs associated with each RRT modality [hemodialysis (HD), peritoneal dialysis (PD) and kidney transplantation (Tx)] were analysed. The Spanish ESRD incidence and prevalence figures in the year 2010 were forecasted in order to enable the calculation of an aggregate cost for each modality. Costs were mainly computed based on a review of the existing literature and of the Official Bulletins of the Spanish Autonomous Communities. Data from Oblikue Consulting eSalud health care costs database and from several Spanish public sources were also employed. RESULTS In the year 2010, the forecasted incidence figures for HD, PD and Tx were 5409, 822 and 2317 patients, respectively. The forecasted prevalence figures were 22,582, 2420 and 24,761 patients, respectively. The average annual per-patient costs (incidence and prevalence) were €2651 and €37,968 (HD), €1808 and €25,826 (PD) and €38,313 and €6283 (Tx). Indirect costs amounted to €8929 (HD), €7429 (PD) and €5483 (Tx). The economic impact of the Spanish RRT programme on the Public Administration budget was estimated at ~€1829 million (indirect costs included): €1327 (HD), €109 (PD) and €393 (Tx) million. CONCLUSIONS HD accounted for >70% of the aggregate costs of the Spanish RRT programme in 2010. From a costs minimization perspective, it would be preferable if the number of incident and prevalent patients in PD were increased.

Cost-Effectiveness Analysis of the Spanish Renal Replacement Therapy Program

♦ Background: We undertook a cost-effectiveness analysis of the Spanish Renal Replacement Therapy (RRT) program for end-stage renal disease patients from a societal perspective. The current Spanish situation was compared with several hypothetical scenarios. ♦ Methods: A Markov chain model was used as a foundation for simulations of the Spanish RRT program in three temporal horizons (5, 10, and 15 years). The current situation (scenario 1) was compared with three different scenarios: increased proportion of overall scheduled (planned) incident patients (scenario 2); constant proportion of overall scheduled incident patients, but increased proportion of scheduled incident patients on peritoneal dialysis (PD), resulting in a lower proportion of scheduled incident patients on hemodialysis (HD) (scenario 3); and increased overall proportion of scheduled incident patients together with increased scheduled incidence of patients on PD (scenario 4). ♦ Results: The incremental cost-effectiveness ratios (ICERs) of scenarios 2, 3, and 4, when compared with scenario 1, were estimated to be, respectively, –€83 150, –€354 977, and –€235 886 per incremental quality-adjusted life year (ΔQALY), evidencing both moderate cost savings and slight effectiveness gains. The net health benefits that would accrue to society were estimated to be, respectively, 0.0045, 0.0211, and 0.0219 ΔQALYs considering a willingness-to-pay threshold of €35 000/ΔQALY. ♦ Conclusions: Scenario 1, the current Spanish situation, was dominated by all the proposed scenarios. Interestingly, scenarios 3 and 4 showed the best results in terms of cost-effectiveness. From a cost-effectiveness perspective, an increase in the overall scheduled incidence of RRT, and particularly that of PD, should be promoted.

Cost–effectiveness analysis of quadrivalent influenza vaccine in Spain

ABSTRACT Influenza has a major impact on healthcare systems and society, but can be prevented using vaccination. The World Health Organization (WHO) currently recommends that influenza vaccines should include at least two virus A and one virus B lineage (trivalent vaccine; TIV). A new quadrivalent vaccine (QIV), which includes an additional B virus strain, received regulatory approval and is now recommended by several countries. The present study estimates the cost-effectiveness of replacing TIVs with QIV for risk groups and elderly population in Spain. A static, lifetime, multi-cohort Markov model with a one-year cycle time was adapted to assess the costs and health outcomes associated with a switch from TIV to QIV. The model followed a cohort vaccinated each year according to health authority recommendations, for the duration of their lives. National epidemiological data allowed the determination of whether the B strain included in TIVs matched the circulating one. Societal perspective was considered, costs and outcomes were discounted at 3% and one-way and probabilistic sensitivity analyses were performed. Compared to TIVs, QIV reduced more influenza cases and influenza-related complications and deaths during periods of B-mismatch strains in the TIV. The incremental cost-effectiveness ratio (ICER) was 8,748€/quality-adjusted life year (QALY). One-way sensitivity analysis showed mismatch with the B lineage included in the TIV was the main driver for ICER. Probabilistic sensitivity analysis shows ICER below 30,000€/QALY in 96% of simulations. Replacing TIVs with QIV in Spain could improve influenza prevention by avoiding B virus mismatch and provide a cost-effective healthcare intervention.

Situación laboral y costes indirectos en pacientes con insuficiencia renal: diferencias entre distintas modalidades de tratamiento renal sustitutivo

BACKGROUND There are evidences of a different employment status between patients undergoing different modalities of renal replacement therapy (RRT). OBJECTIVES The present study aims to compare the indirect costs associated to morbidity in the following RRT alternatives: hemodialysis in a specialized center (HD), automated peritoneal dialysis (APD), continuous ambulatory dialysis (CAPD), and renal transplant (TX). METHODS An analysis on indirect costs was implemented following the Human Capital Theory. In total, 243 patients in working age were included (32 CAPD, 46 APD, 83 HD and 82 TX) from 8 hospitals. The potentially productive years of life lost (PPYL), the costs of lost labor productivity (LLPc) for the year 2009 and the total cost of PPYL (PPYLtc) until age of retirement were estimated. All the estimations were adjusted by age, sex rates. Non-parametric analysis (a bootstrap confidence intervals of differences in costs calculated following the simple bias-corrected percentile method -1,000 estimates-) was computed to highlight differences in costs. RESULTS No significant differences were found in age or sex between groups. LLPc-2009- in HD (6,547€-95% CI: 5,727€-7,366€) was significantly higher (p<.001) than TX (5,079€-95% CI: 4,127€-6,030€) or APD (4,359€-95% CI: 3,064€-5,655€) but not CAPD (5,785€-95% CI: 4,302€-7,269€). PPYLs were: HD 12.58 years-95% CI: 10.42-14.73; TX 10.05-95% CI: 7.45-12.65; APD 6.09-95% CI: 3.43-8.74; CAPD 10.69-95% CI: 6.14-15.23. PPYLtc was higher in HD than in TX, APD or CAPD in all the provided scenarios. CONCLUSIONS TX and, specially, APD are the modalities of RRT with the lowest impact on indirect costs due to morbidity showing higher rates of employment than HD and requiring less disability benefits.

Prevalence, Treatment, and Control of Hypercholesterolemia in High Cardiovascular Risk Patients: Evidences from a Systematic Literature Review in Spain

IntroductionCardiovascular diseases (CVDs) represent a major Public Health burden. High serum cholesterol levels have been linked to major CV risk. The objectives of this study were to review the epidemiology of hypercholesterolemia in high risk CV patients from Spain, by assessing its prevalence, the proportion of diagnosed patients undergoing pharmacological treatment and the degree of attained lipid control.MethodsA systematic literature review was carried out using Medline and two Spanish databases. Manuscripts containing information on hypercholesterolemia in several high CV risk groups [diabetes mellitus (DM), Systematic COronary Risk Evaluation (SCORE) risk >5, or documented CVD], published between January 2010 and October 2014, were included.ResultsOf the 1947 published references initially retrieved, a full-text review was done on 264 manuscripts and 120 were finally included. Prevalence of hypercholesterolemia ranged from 50 to 84% in diabetics, 30–60% in patients with DM or elevated SCORE risk, 64–74% with coronary heart disease, 40–70% in stroke patients, and 60–80% in those with peripheral artery disease. Despite the finding that most of them were on pharmacological treatment, acceptable control of serum lipids was very variable, ranging from 15% to 65%. Among those with heterozygous familial hypercholesterolemia, 95–100% received treatment but less than 50% achieved their therapeutic goals.ConclusionsAn elevated prevalence of hypercholesterolemia can be found in targeted groups at high CV risk. Although most patients are receiving pharmacological treatment, rates of lipid control continue to be low, both in primary and secondary prevention.

Validation of a computer-adaptive test to evaluate generic health-related quality of life.

BackgroundHealth Related Quality of Life (HRQoL) is a relevant variable in the evaluation of health outcomes. Questionnaires based on Classical Test Theory typically require a large number of items to evaluate HRQoL. Computer Adaptive Testing (CAT) can be used to reduce tests length while maintaining and, in some cases, improving accuracy. This study aimed at validating a CAT based on Item Response Theory (IRT) for evaluation of generic HRQoL: the CAT-Health instrument.MethodsCross-sectional study of subjects aged over 18 attending Primary Care Centres for any reason. CAT-Health was administered along with the SF-12 Health Survey. Age, gender and a checklist of chronic conditions were also collected. CAT-Health was evaluated considering: 1) feasibility: completion time and test length; 2) content range coverage, Item Exposure Rate (IER) and test precision; and 3) construct validity: differences in the CAT-Health scores according to clinical variables and correlations between both questionnaires.Results396 subjects answered CAT-Health and SF-12, 67.2% females, mean age (SD) 48.6 (17.7) years. 36.9% did not report any chronic condition. Median completion time for CAT-Health was 81 seconds (IQ range = 59-118) and it increased with age (p < 0.001). The median number of items administered was 8 (IQ range = 6-10). Neither ceiling nor floor effects were found for the score. None of the items in the pool had an IER of 100% and it was over 5% for 27.1% of the items. Test Information Function (TIF) peaked between levels -1 and 0 of HRQoL. Statistically significant differences were observed in the CAT-Health scores according to the number and type of conditions.ConclusionsAlthough domain-specific CATs exist for various areas of HRQoL, CAT-Health is one of the first IRT-based CATs designed to evaluate generic HRQoL and it has proven feasible, valid and efficient, when administered to a broad sample of individuals attending primary care settings.

Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module

BackgroundGeneric utility instruments may not fully capture the impact and consequences of urinary problems. Condition-specific preference-based measures, developed from previously validated disease-specific patient-reported outcomes instruments, may add relevant information for economic evaluations. The aim of this study was to develop a condition-specific preference-based measure, the Incontinence Utility Index (IUI), for valuing health states associated with urinary problems.MethodsA two-step process was implemented. First, an abbreviated health state classification system was developed from the Incontinence Quality of Life Questionnaire (I-QOL) and Neurogenic Module by applying Rasch modelling, classical psychometrical testing and expert criteria to data from two pivotal trials comprised of neurogenic detrusor overactivity (NDO) patients. Criterion, convergent validity and concordance with the original instrument was assessed in the abbreviated version. Then, a multi-attribute utility function (MAUF) was estimated from a representative sample of the UK non-institutionalized adult general population. Visual analogue and time-trade off (TTO) evaluations were applied in the elicitation process. Predictive validity of the MAUF was tested comparing estimated and direct utility scores.ResultsThe abbreviated health state classification system generated from the NDO sample contained 5 attributes with 3 levels of response and had adequate psychometrical properties: significant differences in scores according to the reduction in the frequency of urinary incontinence episodes [UIE] (p < 0.001); Spearman correlation coefficient with number of daily UIE = −0.43; p < 0.01 and Intraclass Correlation Coefficient (ICC, 95% CI) with the original version = 0.90 (0.89-0.91; p < 0.001). Next, 442 participants were interviewed (398 cases were valid, generating 2,388 TTO evaluations) to estimate the social preferences for derived health states. Mean age was 44.75 years (interquartile range 33.5-55.5) and 60.1% were female. An overall algorithm for the IUI was estimated and transformed onto a dead = 0.00 and full health = 1.00 scale. Model fits were acceptable (R-squared = 0.923 and 0.978). Predictive validity was adequate: ICC (95% CI) = 0.928 (0.648-0.985) and Mean of Absolute Differences = 0.038.ConclusionsThe newly developed IUI is a preference-based measure for urinary problems related to NDO that provides general population-based utility scores with adequate predictive validity.Trial registrationClinicalTrials.gov: NCT00461292, NCT00311376.

Desarrollo y validación de un cuestionario genérico para la evaluación de la satisfacción de los pacientes crónicos: Cuestionario SAT-Q

OBJECTIVES To develop and validate a brief general questionnaire to assess satisfaction in patients with chronic disease. DESIGN epidemiological, observational, multicentre cross-sectional study. LOCATION 4 Primary Health Care Centers from the IV Health Area in the Principality of Asturias. SUBJECTS A total of 202 patients diagnosed with chronic illness who were following a pharmacological regimen for at least one year. METHODS An extensive literature review was conducted to create an initial item pool of 61 questions regarding patient satisfaction. Then, a forward-backward translation into Spanish was carried out. Next, both the expert (n=8) and patient (n=30) panels led to a new version of 34 items (concerning satisfaction with medication and satisfaction with health service). Finally, scale item reduction (item-total correlation and exploratory factorial analysis -EFA-) and psychometrical validation (feasibility, reliability and criterion validity) of the SAT-Q- were evaluated. Both the SAT-Q and the SF-12 (to assess patient health related quality of life) were applied. RESULTS Item reduction analysis resulted in 18 items: general satisfaction with medication (3), adverse-events (3), oversights (2), effectiveness (3), convenience (4) and Health services (3). Internal consistency (Cronbach α) and Intraclass Correlation Coefficients were moderate-high. Moreover, significant positive correlations between SAT-Q scores and SF-12 Physical and Mental Summary Components were found (with the exception of oversights). CONCLUSIONS A brief questionnaire for measuring satisfaction in chronic patients has been developed and preliminary validated.

Cost-effectiveness analysis of timely dialysis referral after renal transplant failure in Spain

BackgroundA cost-effectiveness analysis of timely dialysis referral after renal transplant failure was undertaken from the perspective of the Public Administration. The current Spanish situation, where all the patients undergoing graft function loss are referred back to dialysis in a late manner, was compared to an ideal scenario where all the patients are timely referred.MethodsA Markov model was developed in which six health states were defined: hemodialysis, peritoneal dialysis, kidney transplantation, late referral hemodialysis, late referral peritoneal dialysis and death. The model carried out a simulation of the progression of renal disease for a hypothetical cohort of 1,000 patients aged 40, who were observed in a lifetime temporal horizon of 45 years. In depth sensitivity analyses were performed in order to ensure the robustness of the results obtained.ResultsConsidering a discount rate of 3 %, timely referral showed an incremental cost of 211 €, compared to late referral. This cost increase was however a consequence of the incremental survival observed. The incremental effectiveness was 0.0087 quality-adjusted life years (QALY). When comparing both scenarios, an incremental cost-effectiveness ratio of 24,390 €/QALY was obtained, meaning that timely dialysis referral might be an efficient alternative if a willingness-to-pay threshold of 45,000 €/QALY is considered. This result proved to be independent of the proportion of late referral patients observed. The acceptance probability of timely referral was 61.90 %, while late referral was acceptable in 38.10 % of the simulations. If we however restrict the analysis to those situations not involving any loss of effectiveness, the acceptance probability of timely referral was 70.10 %, increasing twofold that of late referral (29.90 %).ConclusionsTimely dialysis referral after graft function loss might be an efficient alternative in Spain, improving both patients’ survival rates and health-related quality of life at an affordable cost. Spanish Public Health authorities might therefore promote the inclusion of specific recommendations for this group of patients within the existing clinical guidelines.

PMH43 THE SPANISH VERSION OF THE TOOL QUESTIONNAIRE: A USEFUL MEASURE FOR EVALUATING THE HRQOL AND UTILITIES FROM SCHIZOPHRENIC AND BIPOLAR PATIENTS

PMH42 HEALTH-RELATED QUALITY OF LIFE OF MARRIED,WORKING WOMENWITH CHILDREN (SUPERWOMAN SYNDROME) IN KOREA Kim S, Park S, Park H Kyung Hee University, Seoul, South Korea, Kyung Hee University, Yongin, Gyeonggi-Do, South Korea, Pochon CHA University, Sungnam, Gyeonggi-Do, South Korea OBJECTIVES: To assess health-related quality of life (QoL) of married, working women with children (working-moms) faced with psychosocial stress (known as superwoman syndrome). METHODS: A total of 200 working-moms (aged 40.2 5.3) were recruited randomly by telephone, and a questionnaire was administered to classify types of superwomen syndrome: selfreliance type (ST), conflict type (CT), and additive type (AT). To compare, a community samples of aged group (n = 80, aged 70.0 5.9) were recruited at a local community center. We measured QoL using SF-36v2 for both groups. RESULTS: As expected younger working-moms reported significantly higher physical function (PF: 79.7 18.7 vs. 71.9 21.9; p = .0031) and mental health (MH: 49.2 15.3 vs. 41.0 14.8; p < .0001). On the contrary role-physical (RP: 78.9 23.6 vs. 80.5 22.5) and role-emotional (RE: 77.2 25.0 vs. 83.2 24.0) scores were lower than aged. Additionally, social functioning (SF) was significantly lower in working-moms (p < .0003). Further by types, most physical-related scales of ST group (n = 10) were significantly higher (all p’s < 0.0025), whereas vitality (VT) and MH were lower than aged.Majority of working-momswere classified as CT group (n = 169). They reported the same QoL patterns as total samples. Notably, AT group (n = 21) reported only MH (62.9 13.8 vs. 41.0 14.8; p < 0.0001) was significantly higher than aged, and rest were either similar (PF, VT), or significantly lower than aged (RP: 62.8 24.6 vs. 80.5 22.5, RE: 55.1 26.6 vs. 83.2 24.0; all p’s < 0.002). CONCLUSIONS: Most workingmoms reported higher functioning and well-being, but in fact they were limited in playing roles due to physical andmental problems. It is suspected that they are denying and suppressing their various health problems. Particularly, additive group report they are in well-being, but the study showed they are definitely not. They even may develop mentally and physically-related diseases in the near future. Therefore, a cohort study is urgent for working, married women with children in Korea.