Javier Soto

Development and Validation of the “Treatment Satisfaction with Medicines Questionnaire” (SATMED‐Q)©

OBJECTIVE To develop and validate a multidimensional generic questionnaire measuring satisfaction with treatment with medicines. The questionnaire was designed to be used in chronic patients undergoing pharmacological treatment for any disease. METHODS After a literature review and cognitive debriefing process with an expert panel of six members and 21 chronic patients in four focus groups, a preliminary instrument with 36 items grouped into six dimensions was developed. Three samples of patients were enrolled during the whole process: 1) 12 patients to assess feasibility and pertinence of items; 2) 150 patients for item reduction; and 3) 455 patients for psychometric properties assessment of the instrument. The latter two were stratified by gender, age, and main disease (type 2 diabetes, hypertension, osteoarthritis, benign prostate hyperplasia, chronic obstructive pulmonary disease/asthma, depression, and migraine). Additional measures were gathered for concept validity: clinical and treatment information, patient and clinician assessment of treatment tolerability and effectiveness, treatment satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM]), and therapeutic compliance (Morisky-Green). Feasibility, reliability, and validity (content, discriminant, construct, and concurrent) were assessed. RESULTS Factor analysis item reduction resulted in a 17-item questionnaire with six dimensions: treatment effectiveness, convenience of use, impact on daily activities, medical care, global satisfaction, and undesirable side effects. Unidimensional scales (Cronbachs alpha ranging 0.813-0.912) were correlated, and allowed computation of a summary composite score (alpha = 0.890). SATMED-Q dimensions showed moderate but significant correlations with TSQM dimensions (0.577-0.680). Differences between tolerability and effectiveness groups were found, depending on dimension and whether the clinician or the patient were informing. Therapeutic compliance groups showed differences in some treatment satisfaction dimensions. CONCLUSIONS The SATMED-Q is a reliable and valid measure of treatment satisfaction, structured in six dimensions, and a summary composite score. Additional work is needed to assess sensitivity to change.

Conjunctival hyperaemia with the use of latanoprost versus other prostaglandin analogues in patients with ocular hypertension or glaucoma: a meta-analysis of randomised clinical trials

Aim: To conduct a meta-analysis of randomised clinical trials (RCTs) in order to evaluate the development of conjunctival hyperaemia after the use of latanoprost versus travoprost and bimatoprost, in patients with ocular hypertension or glaucoma. Methods: In order to identify the potentially relevant RCTs, a systematic literature retrieval was conducted in Medline, Embase and Cochrane Controlled Trials Register (1995–April 2007) databases The outcome measure was the appearance of conjunctival hyperaemia during the study. Statistical analyses included the calculation of odds ratio (OR) and its respective confidence interval, along with intertrial statistical heterogeneity. Publication bias was evaluated through a funnel plot, and a sensitivity analysis was also performed. Results: In total, 13 RCTs involving 2222 patients with ocular hypertension or glaucoma were included, five comparing latanoprost versus travoprost, seven comparing latanoprost versus bimatoprost and one comparing latanoprost versus travoprost and bimatoprost. The combined results showed that latanoprost produced lower occurrence of conjunctival hyperaemia than both travoprost (OR = 0.51; 95% CI 0.39 to 0.67, p<0.0001) and bimatoprost (OR = 0.32; 95% CI 0.24 to 0.42, p<0.0001). No significant heterogeneity was found between the included RCTs. There was no evidence of publication bias. In the sensitivity analysis performed, none of the clinical trials included in this meta-analysis has an important impact in the global estimation of OR. Conclusions: According to available data, the use of latanoprost is associated with a lower incidence of conjunctival hyperaemia when compared with travoprost and bimatoprost in the treatment of patients with ocular hypertension or glaucoma.

Principios, métodos y aplicaciones del análisis del impacto presupuestario en el sector sanitario

Bajo el termino de evaluacion economica se engloban un conjunto de tecnicas o procedimientos que permiten calcular de forma explicita los costes y consecuencias de intervenciones alternativas (Drummond MF 2001), que en el campo sanitario pueden tener distinta naturaleza —programas preventivos, tratamientos farmacologicos, dispositivos medicos, procedimientos quirurgicos, etc.—. Estas tecnicas, cuya caracteristica principal es que en todos los casos intentan describir la eficiencia de intervenciones alternativas mediante un indice que incorpore tanto los costes como los beneficios que conllevan, forman parte, sin ser el todo, de los analisis farmacoeconomicos, que suponen una perspectiva mas amplia en el abordaje del analisis de todas las implicaciones del medicamento: regulacion de precios, financiacion, distribucion, evaluacion economica de medicamentos, etc. Asi pues, aunque guardan concomitancias evidentes, los principales tipos de analisis que incluyen el estudio de diversos aspectos economicos en el sector sanitario no son siempre evaluaciones economicas (Tabla I). Este articulo pretende revisar el estado actual con respecto a la utilizacion de una tecnica de analisis que denominamos analisis del impacto presupuestario. Por analisis del impacto presupuestario entendemos el estudio de la variacion que sobre el presupuesto del ente financiador de una nueva intervencion sanitaria provocara la introduccion de la misma. Esa alternativa puede consistir en una nueva tecnica quirurgica, un nuevo farmaco, una nueva tecnica analitica, etc. Tambien se establecera el grado de conexion que pueda existir entre la evaluacion economica y esta tecnica ya que el ambito y el publico objetivo pueden ser los mismos. Finalmente, se intentan presentar los problemas mas habituales que pueden surgir en su elaboracion y posibles soluciones.

Global spending on orphan drugs in France, Germany, the UK, Italy and Spain during 2007

BackgroundOrphan drugs are indicated for the treatment of rare diseases which, in the EU, are defined as those with a prevalence of <5 per 10 000 inhabitants. Characteristically, these diseases negatively affect health-related quality of life and may be life threatening. The EU has passed legislation to encourage pharmaceutical companies to invest in research programmes into rare diseases, with the aim of developing new, safe and effective orphan drugs.ObjectivesTo describe the status of orphan drugs in five countries in the EU (France, Germany, the UK, Italy and Spain), estimate the mean annual cost per patient and indication of these orphan drugs, and determine the associated cost of these drugs in comparison with overall spending on drugs in each country (year 2007 values).MethodsThe analysis was limited solely to costs of orphan drugs with sales data available for 2007. The mean annual cost per patient was estimated using recommended regimens for maintenance dose and duration from the summary of product characteristics. Likewise, the ratio between annual costs per patient for treatment of each disease and its prevalence was calculated. Sales data were available for at least one of the countries studied for 38 of the 44 orphan drugs authorized by the European Medicines Agency. Only 21 products had data available for all five countries studied.ResultsGermany was the country with access to the largest number of orphan drugs (36), followed by the UK (34), Spain (28), France (27) and Italy (25). The mean annual cost per patient and indication of the 38 orphan drugs on the market ranged widely from €331 to €337 501. It appears that orphan drugs indicated to treat diseases with a prevalence of <2 per 10 000 inhabitants have higher annual per-patient costs than those indicated to treat diseases with a higher prevalence. The percentage of total drug spending accounted for by orphan drugs in 2007 was 1.7% in France, 2.1% in Germany, 1.0% in the UK, 1.5% in Italy and 2.0% in Spain, with an average overall percentage of 1.7% for these five countries.ConclusionsIn 2007, spending on orphan drugs in five European countries was acceptable in terms of the percentage of these countries’ overall drug expenditure. Mean annual costs per patient of orphan drugs varied widely, with costs being related to the prevalence of the disease for which the product is indicated.

Adaptación y validación del Health Utilities Index Mark 3 al castellano y baremos de corrección en la población española

Fundamento y objetivo El Health Utilities Index Mark 3 (HUI-3) es un instrumento que permiteatribuir utilidades a los estados de salud. Se presenta la adaptacion y validacion al castellano, asicomo la estimacion de las utilidades en la poblacion espanola comparandola con la canadiense. Pacientes y metodo El proceso de adaptacion se ha realizado siguiendo el protocolo de Furlong.Se selecciono un panel de expertos para garantizar el proceso, la traduccion del cuestionario y elentrenamiento de los entrevistadores. Se han utilizado dos muestras: una de modelado destinadaa desarrollar la funcion de utilidad multiatributo (MAUF) y una de medicion directa para validarla MAUF. Ambas muestras son representativas de la poblacion espanola. Para estimar lasutilidades asociadas a cada estado de salud se han utilizado: la Escala Visual Analogica y laApuesta Normalizada o Juego Estandar. La dimensionalidad del instrumento se ha analizado medianteanalisis factorial y la validez convergente se ha comprobado con el EuroQoL. Resultados La version espanola del HUI-3 es factible ( Conclusiones El cuestionario puede aplicarse de forma individual o colectiva y de forma autoadministradao mediante entrevista. Los indices psicometricos obtenidos son buenos. Las diferenciasencontradas entre las funciones de utilidad espanola y canadiense hacen necesario utilizarcomo referente las funciones especificas de cada poblacion.

Cuestionario sobre calidad de vida asociada a dispepsia. Adaptación española y validación del cuestionario Dyspepsia Related Health Scale

Fundamento La dispepsia es una enfermedad que afecta en torno al 25% de la poblacion y que origina un deterioro importante de la calidad de vida. El objetivo de este trabajo fue efectuar una validacion y adaptacion al castellano del cuestionario Dyspepsia Related Health Scales (DRHS), un instrumento que evalua la calidad de vida asociada a la dispepsia. Pacientes y metodo El estudio se efectuo en 234 sujetos, 163 con sintomatologia de dispepsia y 71 voluntarios sanos, e intervinieron dos reumatologos, dos medicos de familia, un gastroenterologo, un farmacologo clinico, un farmacoepidemiologo y un psicologo de la medicion. El proceso de adaptacion y validacion ha constado de las siguientes fases: traduccion-retraduccion, estudio piloto en 16 pacientes, dimensionalidad, fiabilidad y validez (de contenido, de constructo, convergente, predictiva y discriminante). Resultados La edad media (desviacion estandar) de los individuos de la muestra fue de 49,1 (18 anos) y el 60,7% eran mujeres. El indice de acuerdo interjueces de Hambleton y Rovinelli, que evalua la validez de contenido, siempre estuvo por debajo de 0,41. La validez de constructo, valorada a traves del analisis factorial de las respuestas de los encuestados, demostro que cada una de las subescalas puede considerarse como unidimensional, tanto en voluntarios sanos como en sujetos con dispepsia. La fiabilidad encontrada fue satisfactoria (alfa de Cronbach = 0,92) y la estabilidad de las medidas (test-retest) fue excelente, con un coeficiente de correlacion de 0,95. La validez convergente con el EuroQoL resulto ser moderada, con un coeficiente de correlacion de 0,54 (p Conclusiones La version espanola del DRHS, denominada QoL-PEI (cuestionario de calidad de vida en relacion con los problemas de estomago e intestinales) presenta buenas propiedades metricas y ha demostrado ser capaz de predecir la evolucion de la dispepsia. Los resultados demuestran que el comportamiento del cuestionario es eminentemente unidimensional, si bien puede ser utilizado de forma multidimensional para una valoracion diferenciada del caso evaluado.

Development of a Specific Questionnaire Measuring Patient Satisfaction with Glaucoma Treatment: Glausat

Objective: Patient satisfaction with glaucoma therapy is one of the aspects that affects adequate adherence to treatment; therefore, it would be interesting to measure the satisfaction properly. We present the development process and psychometric properties of a new instrument for measuring patient satisfaction with glaucoma treatment. Material and methods: After collection and discussion of contents, a 38-item questionnaire was proposed and arranged into seven theoretical domains. The questionnaire was applied to a sample of 194 patients and its length was reduced using an exploratory factor analysis. Psychometric properties were assessed under classic theory. Results: The final questionnaire is formed by 22 items grouped into seven dimensions: expectations and beliefs about treatment, ease of use, efficacy, undesired effects, impact on health-related quality of life, medical care, and general satisfaction with treatment. Some dimensions correlated slightly. The reliability of the dimensions ranged from 0.77 to 0.93. Confirmatory factor analysis revealed an additional support of the proposed structure (χ2 (188) = 217, P = 0.073). Glausat scores were proven to correlate with patients’ self rating on medication tolerability, and with clinicians’ assessment of tolerability, effectiveness and compliance. Conclusions: The Glausat questionnaire has proven to be reliable and structurally valid. This instrument may be used to assess patients’ satisfaction with glaucoma treatment.

Drug Utilisation Studies as Tools in Health Economics

SummaryDrug utilisation and many pharmacoeconomic studies use pharmacoepidemiological methods characterised by the study of drugs from a socioeconomic perspective. Drug utilisation studies may be defined as studies of the marketing, distribution, prescription and use of drugs in a society, with special emphasis on the resulting medical, social and economic consequences. Pharmacoeconomic studies are used to measure drug efficiency, through comparison of the costs and effects of alternative therapies.Drug utilisation studies can provide highly valuable information, at a reasonable price, on the costs and effects (harmful and beneficial) of drugs. Such studies make available much useful information including indirect data on morbidity, the pharmaceutical component of the treatment cost of an illness, therapeutic compliance, the incidence of adverse reactions, the effectiveness of drug consumption and the choice of comparators. This information can k of great use in the subsequent elaboration of phamacoeconomic studies, or in the selection of problematic areas in which these studies may be applied.Pharmacoeconomic studies, in turn, can be used to discover the economic repercussions of inappropriate prescribing and to quantify the cost effectiveness of various therapeutic interventions.The use of drug utilisation studies in conjunction with pharmacoeconornic analysis can result in more cost effective utilisation of medicines and a better utilisation of pharmacoeconomic methods, both of which contribute to a more rational use of drugs.

AdaptaciÓn al castellano y validaciÓn del cuestionario Arthritis Treatment Satisfaction Questionnaire

Fundamento y objetivo Adaptacion linguistica y validacion al castellano del cuestionario ARTS (Arthritis Treatment Satisfaction Questionnaire), instrumento autoadministrado que mide cuatro dimensiones de satisfaccion con el tratamiento de la artrosis: eficacia, conveniencia, tolerabilidad y cuidado medico. Material y metodo La adaptacion se llevo a cabo mediante equivalencia conceptual, fue supervisado por 6 expertos y 4 traductores que tradujeron y retrotradujeron los items. Se utilizo una muestra de pacientes con artrosis de rodilla, cadera o columna cervical para estimar las propiedades psicometricas de factibilidad, fiabilidad, validez y sensibilidad al cambio. Se identificaron 3 grupos: escaso efecto analgesico, escasa tolerabilidad y adecuado efecto analgesico y tolerabilidad. El ARTS se administro basalmente, a la semana, y despues de 4 semanas de tratamiento con antiinflamatorios no esteroideos o con inhibidores de la ciclooxigenasa 2. Resultados Se incluyo a 163 pacientes de edad media (DE) de 67,7 (9,2) anos. No se observo efecto suelo o techo, los items se entendieron correctamente y las tasas de ausencia de respuesta resultaron inferiores al 1%, con un α de Cronbach de 0,85 y coeficiente de correlacion intraclase de 0,81. El analisis factorial exploratorio mostro cuatro dimensiones coherentes con la version original. La validez concurrente se evaluo con la escala SF-36, la escala EVA de dolor, la escala EVA de cumplimiento terapeutico y el cuestionario de Morisky-Green. El cuestionario adaptado mostro tambien una buena validez discriminante, y fue capaz de distinguir entre pacientes que requieren cambio de tratamiento. Tambien demostro sensibilidad al cambio en la efectividad del tratamiento tras 30 dias de seguimiento. Conclusiones La version adaptada del cuestionario ARTS es psicometricamente valida y conceptualmente equivalente para explorar la satisfaccion con el tratamiento de la artrosis en lengua espanola.

Minimally important difference of the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)

BackgroundA previous study has documented the reliability and validity of the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) in exploring patient satisfaction with medicines for chronic health conditions in routine medical practice, but the minimally important difference (MID) of this tool is as yet unknown. The objective of this research was to estimate the MID for the SATMED-Q total score and six constituent domains.MethodsThe sample of patients (456 subjects, mean age 59 years, 53% male) used for testing psychometric properties was also used to assess MID. Item #14 of the Treatment Satisfaction Questionnaire for Medication (TSQM) was used as an anchor reference since it directly explores satisfaction with medicine on a 7-point ordinal scale (from extremely satisfied to extremely dissatisfied, with a neutral category). Patients were classified into four categories according to responses to this item (extremely satisfied/dissatisfied, very satisfied/dissatisfied, satisfied/dissatisfied, neither satisfied nor dissatisfied (neutral), and calculations were made for the total score and each domain of the SATMED-Q using standardised scores. The mean absolute differences in total score (and domains) between the neutral category and the satisfied/dissatisfied category were considered to be the MID. Effect sizes (ES) were also computed.ResultsThe MID for the total score was 13.4 (ES = 0.91), while the domain values ranged from 10.3 (medical care domain, ES = 0.43) to 20.6 (impact on daily living, ES = 0.85). Mean differences in satisfaction (as measured by the total SATMED-Q score and domain scores) using the levels of satisfaction established by item #14 were significantly different, with F values ranging from 12.2 to 88.8 (p < 0.001 in all cases).ConclusionThe SATMED-Q was demonstrated to be responsive to different levels of patient satisfaction with therapy in chronically ill subjects. The MID obtained was 13.4 points for the overall normalised scoring scale, and between 10.3 and 20.6 points for domains.