José Antonio Sacristán

Qué es una tecnología sanitaria eficiente en España

Introduccion: A pesar del creciente reconocimiento de la potencial utilidad de los estudios de coste-efectividad, en Espana no existe ningun criterio que permita establecer si una determinada tecnologia sanitaria puede considerarse rentable o no. El objetivo de este trabajo es describir cuales han sido los limites y criterios utilizados en Espana para recomendar la adopcion o el rechazo de intervenciones sanitarias en funcion de su coste-efectividad. Metodo: Se realizo una revision de las evaluaciones economicas de intervenciones sanitarias publicadas en Espana desde 1990 hasta 2001. Se seleccionaron las evaluaciones economicas completas en las que el cociente coste-efectividad se habia expresado como coste por ano de vida ganado (AVG), como coste por ano de vida ajustado por calidad (AVAC) o como coste por vida salvada. Se analizaron las intervenciones sobre las que los autores establecieron algun tipo de recomendacion (de adopcion o rechazo), asi como los criterios utilizados. Resultados: Veinte (20%) de las 100 evaluaciones economicas completas publicadas cumplieron con los criterios senalados. En 16 de los estudios, los resultados se expresaron como coste por AVG, en 6 como coste por AVAC y en 1 como coste por vida salvada. Se evaluaron un total de 82 intervenciones sanitarias, en 44 de las cuales se realizo algun tipo de recomendacion. Los autores recomendaron la adopcion de todas las intervenciones sanitarias con un coste-efectividad inferior a 30.000 euros (5 millones de pesetas) por AVG. Por encima de esa cifra no se aprecio ninguna tendencia. Conclusiones: Si bien los resultados deben ser interpretados con mucha precaucion, dadas las limitaciones del estudio, los limites de coste-efectividad presentados en este trabajo podrian constituir una primera referencia a lo que podria considerarse como una intervencion sanitaria eficiente en Espana.

Allopurinol Hypersensitivity Syndrome: A Review

OBJECTIVE: To review the pathophysiology, pathology, and clinical findings of allopurinol hypersensitivity syndrome (AHS), an infrequent but life-threatening adverse effect of allopurinol therapy. DATA SOURCES: A MEDLINE search (key terms hepatitis, interstitial nephritis, severe hypersensitivity, severe toxicity, vasculitis, toxic epidermal necrolysis, Lyells syndrome, erythema multiforme, and Stevens-Johnson syndrome) was used to identify cases reported in the literature through the end of 1990. STUDY SELECTION: All cases evaluated met Singer and Wallaces diagnostic criteria for AHS. DATA EXTRACTION: We extracted data from 101 cases of AHS reported in the literature. The following information, when available, was analyzed: (1) patient data (age, gender, medical history), (2) treatment data (daily dosage of allopurinol, duration of treatment, indications, concomitant medications, and (3) adverse-event data. DATA SYNTHESIS: Patients were mostly middle-aged men with hypertension and/or renal failure receiving excessive doses of allopurinol primarily for asymptomatic hyperuricemia. Cutaneous rash and fever were the most common clinical findings. CONCLUSIONS: Although the pathophysiologic pathway leading to the development of AHS is unknown, it probably involves an immunologic mechanism following allopurinol accumulation in patients with poor renal function. Our findings suggest that the accepted diagnostic criteria for AHS may be too broad, and we recommend the application of more restrictive criteria. There is no effective treatment for AHS. The use of allopurinol only for accepted indications and in dosages adjusted for a patients renal function may be the only means of minimizing the incidence of AHS.

Problems and solutions in calculating quality-adjusted life years (QALYs)

The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life and quality of life, the QALY was developed as an attempt to combine the value of these attributes into a single index number. The QALY calculation is simple: the change in utility value induced by the treatment is multiplied by the duration of the treatment effect to provide the number of QALYs gained. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY. This parameter can be used to compare the cost-effectiveness of any treatment.Nevertheless, QALYs have been criticised on technical and ethical grounds. A salient problem relies on the numerical nature of its constituent parts. The appropriateness of the QALY arithmetical operation is compromised by the essence of the utility scale: while life-years are expressed in a ratio scale with a true zero, the utility is an interval scale where 0 is an arbitrary value for death. In order to be able to obtain coherent results, both scales would have to be expressed in the same units of measurement. The different nature of these two factors jeopardises the meaning and interpretation of QALYs. A simple general linear transformation of the utility scale suffices to demonstrate that the results of the multiplication are not invariant.Mathematically, the solution to these limitations happens through an alternative calculation of QALYs by means of operations with complex numbers rooted in the well known Pythagorean theorem. Through a series of examples, the new calculation arithmetic is introduced and discussed.

What is an efficient health technology in Spain

INTRODUCTION Despite the growing recognition of the potential applications of cost-effectiveness assessments, a criterion to establish what is an efficient health technology does not exist in Spain. The objective of this work is to describe the limits and the criteria used in Spain to recommend the adoption of health interventions. METHOD A review of the economic evaluations of health technologies published in Spain from 1990 to 2001 was conducted. Complete economic assessments in which the cost-effectiveness ratio was expressed as cost per life-year gained (LYG), cost per quality-adjusted-life-year (QALY) or cost per saved live were selected. Those interventions in which the authors established recommendations (adoption or rejection) and the criteria used were analyzed. RESULTS Twenty (20%) of the 100 complete economic evaluations fulfilled the selection criteria. In16 studies, the results were expressed as cost per LYG, in 6 studies as cost per QALY and in 1 as cost per saved live. A total of 82 health interventions were assessed and some kind of recommendation was established in 44 of them. All technologies with a cost-effectiveness ratio lower than 30,000 euros (5 million pesetas) per LYG were recommended for adoption by the authors. Up to that limit there was no a clear tendency. CONCLUSIONS Although the results must be interpreted with much precaution, given the limitations of the study, the limits of cost-effectiveness presented in this work could be a first reference to which would be an efficient health intervention in Spain.

Psychometric validation of a generic health-related quality of life measure (EQ-5D) in a sample of schizophrenic patients

SUMMARY Objective: The aim of this study was to evaluate the construct validity of a generic health related quality of life (HRQOL) instrument – the EQ-5D – in a sample of schizophrenic patients receiving antipsychotic treatment. Research design and methods: A total of 2128 schizophrenic patients treated with olanzapine, 417 treated with risperidone, and 112 with haloperidol responded to the EQ-5D. The study also assessed the effect of patient age, gender, and co-morbidity variables on patients HRQOL Main outcomes measures: EQ-5D scores at the start of treatment and after 3 and 6 months of therapy were compared with results from the Clinical Global Impression (CGI) severity of illness scale and the (GAF) scale. The effect of antipsychotics and sociodemographic variables on patients HRQOL over time was tested through a three-factor doubly multivariate repeated measures MANCOVA. Results: High scores in the GAF scale and low scores in the CGI were linked with high scores on the EQ-5D scale. The correlational effects observed between the EQ-5D and the clinical indices ranged from 0.33 to 0.54. A significant effect of ‘visit time’ as well as an interaction of ‘visit time’ x drug, ‘visit time’ x gender, and ‘visit time’ x co-morbidity was observed. Conclusions: Results suggest the EQ-5D is a valid instrument capable of detecting HRQOL differences between schizophrenic patients with different degrees of severity of illness.

Evaluation of Pharmacoeconomic Studies: Utilization of a Checklist

OBJECTIVE: To review the fundamental concepts used in clinical economic analysis and establish a simple model to systematically evaluate the quality of pharmacoeconomic studies. DATA SOURCES: A MEDLINE search was used to identify pertinent pharmacoeconomic literature, including reviews. STUDY SELECTION: Selected literature evaluating the methodology of health economics studies was used. CONCLUSIONS: The number of studies presenting a pharmacoeconomic evaluation has increased progressively; however, the quality of the studies has not improved in parallel. The existence of different types of pharmacoeconomic studies does not justify their arbitrary use and the achievement of valid conclusions must be based on sound knowledge of the concepts employed, as well as on use of the most adequate tool in each instance. By evaluating pharmacoeconomic studies systematically, the more common errors (i.e., in planning the study or interpreting the results) can be detected and thus prevented. The checklist we present has 12 sections, each of which includes several subsections. After evaluating the corresponding subsections, each section is labeled as “correct”, “acceptable”, “doubtful”, “incorrect”, or “not applicable.” From this qualitative evaluation, aspects that have been dealt with correctly and those needing improvement will become apparent. Also, the checklist permits the user to verify whether the results have been correctly obtained and, therefore, whether the conclusions are valid. The use of a checklist for evaluating pharmacoeconomic studies may be useful for researchers, journal editors, and the audience when performing, receiving, reading, or accepting a clinical economic study.

A Rasch model analysis to test the cross-cultural validity of the EuroQoL-5D in the Schizophrenia Outpatient Health Outcomes Study

Objective:  To investigate the pan‐European, cross‐cultural validity of the EuroQol‐5D (EQ‐5D) for assessing quality of life in the Schizophrenia Outpatient Health Outcomes (SOHO) Study.

Doses of Olanzapine, Risperidone, and Haloperidol Used in Clinical Practice: Results of a Prospective Pharmacoepidemiologic Study

OBJECTIVE The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. METHODS The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score < or = 4. RESULTS A total of 2657 patients were included in the analysis. The initial and overall mean daily doses for the 3 groups were as follows: OLZ, 12.2 and 13.0 mg, respectively; RIS, 5.2 and 5.4 mg; and HAL, 13.9 and 13.6 mg. Initial and overall median daily doses were the same in each group: OLZ, 10 mg; RIS, 6 mg; and HAL, 10 mg. A significantly lower proportion of OLZ-treated patients (36.9%) experienced EPS compared with RIS-treated (49.6%) and HAL-treated (76.0%) patients (P < or = 0.001). A significantly lower proportion of patients in the OLZ group (47.8%) experienced adverse events compared with patients in the RIS (57.2%) and HAL (79.8%) groups (P < or = 0.001). A significantly greater proportion of OLZ-treated patients (37.3%) were responders compared with RIS-treated patients (31.5%) (P < 0.05). In all 3 groups, patients who had an initial CGI score > or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). CONCLUSION The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

Economic evaluation in a randomized phase III clinical trial comparing gemcitabine/cisplatin and etoposide/cisplatin in non-small cell lung cancer☆

INTRODUCTION Information on the relative cost-effectiveness of treatments for cancer is being increasingly sought as pressure on health care resources increases. The objective of this study was to assess the cost-effectiveness of gemcitabine/cisplatin (GC) versus cisplatin/etoposide (CE) in patients with advanced non-small cell lung cancer (NSCLC), using resource utilization data collected in conjunction with the first randomized clinical trial comparing both combinations. METHODS Efficacy and medical care resource utilization data were collected prospectively in an open-label, multicenter, randomized, comparative, phase III trial conducted in Spain which compared gemcitabine/cisplatin and cisplatin/etoposide in 135 chemonaive patients with Stage IIIB or IV NSCLC. There were no differences between both regimens when survival was used as primary end-point, so a cost-minimization analysis was used to compare them. In addition, cost-effectiveness analyses were conducted when percentage of responses and time to progression were used as secondary end-points. RESULTS There were no differences between both regimens when survival was selected as the efficacy end-point. Despite the higher chemotherapy cost of GC when compared to CE, there were no differences in total direct costs (584523 pts for GC and 589630 pts for CE; P=NS) between both regimens. Potential savings with GC were mainly associated with a decrease in hospitalization rate. There were differences in favor of GC when response rate (40.6% for GC and 21.9% for CE; P<0.05) and time to disease progression (8.7 months for GC and 7.2 months for CE; P<0. 05) were used as clinical end-points. GC presented a favorable cost-effectiveness profile when compared to CE. CONCLUSIONS This prospective economic evaluation conducted alongside a clinical trial offers valuable preliminary information on the potential efficiency of the combination gemcitabine-cisplatin in NSCLC. Future assessments based on larger clinical trials focused on survival and naturalistic economic studies conducted in real clinical practice settings are necessary to confirm these findings.

Análisis de costes y resultados en la evaluación económica de las intervenciones sanitarias

El objetivo fundamental de cualquier sistema sanitario esmaximizar el nivel de salud de la poblacion a la que da co-bertura. Desgraciadamente, los recursos economicos dispo-nibles para tal fin no suelen ser suficientes para cubrir todaslas necesidades que en este ambito se presentan. Por estarazon, los agentes que toman las decisiones deben estable-cer que acciones resultan prioritarias para poder maximizarel beneficio producido con los recursos disponibles