[Risk sharing agreements: with orphan drugs?]. / Contratos de riesgo compartido, ¿con medicamentos huérfanos?

OBJECTIVE: To summarize available information on share risk agreements (RSA) with orphan drugs (OD). METHODS: A bibliographic search was carried out in MEDLINE, EMBASE and INAHTA using 19 keywords and combinations thereof. Papers published as original, narrative and systematic reviews, editorials, commentaries, letters to the Editor, and special articles were included and reviewed. Public or private institutional reports or documents found in Google that contained relevant information were also reviewed. RESULTS: experience gained so far with RSA is scant. No published rigorous evaluations of outcomes of these agreements were found. It seems, however, that OD are suitable for introduction in clinical practice by means of RSA. There are two main types of RSA: financially based, and performance-outcome based. A number of theoretical advantages of SRA are described, as well as hurdles that hinder their design, implementation, and followup, and thus endangering their success. Very few RSA have clearly succeed so far. CONCLUSIONS: If thoroughly managed, RSA may reasonably contribute to value-based pricing of OD, improve their pharmacovigilance, knowledge about their comparative effectiveness, and to reducing uncertainty and its consequences on patients, industry, payers and clinicians. There are technical groups that can bring the essential knowledge to manage RSA in Spain. The challenge now is to be able to harmonize their assessments and appraisals, to put in motion the mechanisms needed to overcome those hurdles, and to provide them adequate political and institutional support.

Design and validation of a scale to assess preferences of type 2 diabetic patients towards different nutritional supplements.

OBJECTIVES: To design and validate a scale to evaluate preferences of type 2 diabetic patients towards nutritional supplements (Madrid scale) and to discover those taste attributes that are more discriminating. CONTEXT: ambulatory patients with type 2 diabetes mellitus. MATERIALS AND METHODS: 18 controls and 106 type 2 diabetic patients received 2 of the 7 stimuli studied (6 nutritional supplements and a differential salty stimulus) and then completed both scales and a criterion question. Two weeks later, 30 diabetic patients received a retest. The psychometric properties of the Madrid scale were studied and the relative importance of each stimuli attribute was assessed. RESULTS: Feasibility: The Madrid scale consists of 8 questions and is completed in less than five minutes; Dimensionality: A single dimension which explains 45.1% of the variance. Reliability: Cronbach's , 0.806; intraclass correlation coefficient, 0.835 (95% confidence interval: 0.653-0.922). Concurrent validity: Correlation indexes of the corrected total score with the criterion question and the Modified Wine-Tasting Scale, 0.731 (p < 0.0005) and 0.774 (p < 0.0005), respectively. The scale discriminated between subjects younger and older than 75 years and between supplements and the differential stimulus. Preferences: Glucerna SR chocolate, Glucerna SR strawberry, Glucerna SR vanilla, Diasip vanilla, Clinutren vanilla and Resource diabet vanilla. CONCLUSION: The Madrid scale has adequate psychometric properties for its use in research and daily clinical practice.

Evaluación de costes en cuidados intensivos. A la búsqueda de una unidad relativa de valor / Costs evaluation in intensive care in search of a costs proxy

Introducción. La gestión clinicofinanciera de una UCI requiere un método para aproximar los costes individuales y establecer una unidad relativa de valor. Se pretende analizar los costes reales y su estimación mediante índices de gravedad y de actividad terapéutica, así como valorar si a escala individual el índice NEMS podría ser de utilidad para su medición. Pacientes y método. Se trata de un estudio de cohorte de pacientes ingresados en la UCI durante el año 2000. Mediante muestreo aleatorio estratificado se seleccionó a 106 pacientes de los 14 grupos relacionados por el diagnóstico (GRD) finales más habituales. Se llevó a cabo un registro de costes variables directos de cada paciente con asignación de costes fijos directos e indirectos en función de las estancias. Se midieron: estancia, índices de gravedad fisiológica (APACHE II, SAPS II, MPM0, MPM24) y de dependencia terapéutica (NEMS, TISS-28 y OMEGA). El análisis estadístico se basó en el coeficiente de correlación de Spearman (CCS) entre costes totales e índices. Se realizó una comparación entre los costes reales y los teóricos calculados sobre la base del NEMS mediante la mediana de la diferencia de dichos costes (AMD; percentil 5 y 95) y el análisis de Bland y Altman. Los valores se expresan en forma de media (intervalo de confianza [IC] del 95 por ciento). Resultados. Se seleccionó a 106 de los 861 pacientes con estancia mayor o igual a un día, 74 de los cuales eran varones. La edad media fue 68,2 años (65,4-71,0); la estancia media fue de 7,3 días (5,3-9,3); el APACHE II medio, de 17,6 (16,019,2); el NEMS, de 219,7 (153,7-285,8); el peso del GRD, de 5,8 (4,6-6,9); la media de coste/paciente, de 6.767,34 euros (4.919,95-8.614,74); la financiación GRD/paciente, de 6.282,29 euros (4.992,827.571,76); la media de coste/NEMS, de 12,42 euros (11,09-13,76), y la relación coste/estancia, de 921,28 euros (888,22-954,34). Los valores del CCS fueron los siguientes: estancia, r = 0,98 (p = 0,000); APACHE II, r = 0,36 (p = 0,000); SAPS II, r = 0,27 (p = 0,007); MPM0, r = 0,20 (p = 0,032); MPM24, r = 0,21 (p = 0,029); NEMS, r = 0,92 (p = 0,000); TISS-28, r = 0,91 (p = 0,000); OMEGA, r = 0,85 (p = 0,000), y peso GRD, r = 0,55 (p = 0,000). AMD: -154,71 (-3.719,86 a 958,07). Conclusiones. El cálculo de costes mediante el método descrito resulta más aproximado que la asignación por GRD. La estancia es el componente de mayor impacto en los costes totales. El NEMS puede ser de utilidad para calcular costes reales. Aun existiendo individualmente diferencias entre costes reales y calculados, el método utilizado puede resultar de gran utilidad para calcular los recursos financieros de una UCI (AU)

[Qualitative analysis of organizational innovations in Spanish public hospitals]. / Análisis cualitativo de las innovaciones organizativas en hospitales públicos españoles.

OBJECTIVE: To determine the opinion of chief executive officers (CEOs) and physicians in public hospitals concerning new managerial trends. METHODS: We performed a qualitative study designed to determine the opinion of CEOs and physicians on the organizational innovations that affect more than one level of health management intervention. In-depth semi-structured interviews were conducted to identify behavior, experiences, opinions, knowledge and other personal and institutional aspects related to the study's aim. Focus groups (two study groups and one control group) were also used. Interaction between groups was used to obtain different types of information on the development of ideas, operational capacity, and the degree of consensus and disagreement on the subjects discussed. RESULTS: Comparison between the control and the study groups revealed that the new management trends added value in the following areas: economy of contracts, delegation, administrative decentralization, incentives, risk avoidance, process re-engineering, heath care continuity, competitiveness, leadership, information systems and client centeredness. CONCLUSIONS: Physicians are showing increased interest in organizational innovations while CEOs are ambivalent about their changing role and respective responsibilities. There is evidence of resistance to change. There is no single institutional model; institutional design depends on internal factors (cohesion and leadership) and external factors (environment, size and technology). The incipient development of innovations reveals the need for changes in the style and characteristics of management structure (composition, functions, responsibilities).

¿Qué es una tecnología sanitaria eficiente en España? / What is an efficient health technology in Spain?

Introducción: A pesar del creciente reconocimiento de la potencial utilidad de los estudios de coste-efectividad, en España no existe ningún criterio que permita establecer si una determinada tecnología sanitaria puede considerarse rentable o no. El objetivo de este trabajo es describir cuáles han sido los límites y criterios utilizados en España para recomendar la adopción o el rechazo de intervenciones sanitarias en función de su coste-efectividad. Método: Se realizó una revisión de las evaluaciones económicas de intervenciones sanitarias publicadas en España desde 1990 hasta 2001. Se seleccionaron las evaluaciones económicas completas en las que el cociente coste-efectividad se había expresado como coste por año de vida ganado (AVG), como coste por año de vida ajustado por calidad (AVAC) o como coste por vida salvada. Se analizaron las intervenciones sobre las que los autores establecieron algún tipo de recomendación (de adopción o (..) (AU)

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 (..) (AU)

[What is an efficient health technology in Spain?]. / Qué es una tecnología sanitaria eficiente en España?

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.

Nutritional support in chronic renal failure: systematic review.

BACKGROUND AND AIMS: The purpose of this systematic review was to locate and assess in patients with chronic renal disease the quality of scientific evidence to establish graded recommendations based on the efficacy and effectiveness of nutritional support. METHODS: Computerized and online versions of MEDLINE (from 1989 through March 1999) and EMBASE (from 1988 through January 1999) were consulted. The Cochrane Library and the online Healthstar (from 1975) databases were also searched for clinical trials. A total of 593 studies were assessed. Following methodological review (primary reviewer), only 45 studies reviewed met criteria for selection and were analyzed by a group of experts (secondary reviewer). A final consensus was reached between the co-ordinators, experts and methodologists. RESULTS AND CONCLUSIONS: Low and very low-protein diets associated with specific enteral supplements are indicated in most patients with chronic renal disease and in patients with incipient diabetic nephropathy to slow progression of disease and to improve their overall status, contributing to improved survival (grade A recommendation). The use of protein-restricted diets in diabetic nephropathy is only indicated in type I diabetes mellitus (grade A recommendation). An improvement in nutritional parameters was found when specific diets were given in chronic renal disease (grade C recommendation).

[Health outcomes research]. / Investigación de resultados en salud.

Health outcomes research (HOR) is an important source of knowledge regarding the effectiveness of health care treatments and interventions which focus on providing benefits in terms of those results which are important for patients. Medical research has traditionally focussed on the measurement of clinical variables, such as symptoms or laboratory tests, as a means of determining the results of medical interventions. Although HOR uses such tests, it also places great emphasis on the use of other measures such as health-related quality of life, satisfaction with treatment, and cost-effectiveness. The results obtained should be incorporated in the evaluative process and in disease management to determine the effectiveness of health care services in improving the population's health.

[Approach to health in Spain]. / Aproximación a la salud en España.

PIP: 2 closely related aspects of health assessment are the definition of health and the purpose of the measurement. Health indicators are variables that may be used to evaluate hospital or community health care, detect unsatisfied needs, quantify the impact of an illness in daily life, examine costs and benefits of a particular program, determination priorities, or for other purposes. Life expectancy and the infant mortality rate are considered more useful from an operational perspective and for comparisons than is the crude death rate because they are not influenced by age structure. Morbidity rates are less available and are subject to wide variations of quality. Significant changes have occurred in Spain's fertility and mortality rates in the past few decades. Between 1970-80, the crude birth rate declined from 19.55 to 15.21/1000, the crude death rate from 8.41 to 7.71/1000, the infant mortality rate from 26.30 to 12.34/1000 live births, and the perinatal mortality rate from 25.48 to 14.35/1000 live births. Life expectancy at birth increased from 34.8 years for both sexes in 1900 to 73.3 in 1975. The changes in mortality and fertility rates have led to changes in Spain's age structure, primarily a gradual aging of the population. Chronic diseases have assumed new importance as causes of death. In 1980, circulatory diseases caused 43.8% of deaths, followed by tumors with 20.2% and respiratory diseases with 9.3%. The most important single cause of death in 1979 for children under 14 was accidents, for adults aged 15-64 it was tumors, and for persons over 65 it was cardiovascular diseases. The evolution of Spain's age structure is similar to that of other developed countries, although the proportion of children under 15 continues to be higher and that of persons over 65 to be lower.^ieng