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SummaryThe objective of this study was to evaluate the economic and organisational consequences of the substitution of pamidronate with zoledronic acid in the adjunct treatment of bone metastasis in patients with breast cancer and multiple myeloma in a European context.A cost minimisation analysis was carried out. Clinical data were extracted from clinical trials of pamidronate versus zoledronic acid. Resource consumption and cost data were collected at different Spanish oncology infusion sites.While the acquisition cost of zoledronic acid is higher compared with pamidronate, zoledronic acid is superior to pamidronate for the treatment of hypercalcaemia of malignancy and in avoiding palliativeradiotherapy. Moreover, it is at least as effective as 90 mg pamidronate in reducing skeletal complications in patients with bone lesions from myeloma or breast cancer. It therefore reduced nurse monitoring, occupation of infusion chairs and radiotherapy sessions, implying savings in health care resources. The net of...

In Spain, the new Medicine degrees of the European Higher Education Area (EHEA) have incorporated Information Technologies (IT) subjects to develop horizontal competences in their curriculum. Medicine Studies are costly for Higher Education (HE) institutions and, then, every cost-effective educational innovation is welcomed. There are different general approaches for designing and developing serious games in general, but specific target disciplines as Medicine (educational and professional training), lack of tailor-made methodologies, even in eliciting requirements under the Requirements Engineering (RE) framework, as a subfield of Software Engineering. In medical higher education, the main objective of using games is to engage learners in complex problem spaces that replicate real world situations, as it happens in hospital emergencies, surgery operations and so on, without the constraints and risks of the day to day practice (patient injuries, health complications and death). Therefore, the development of serious HE games is a complex, time consuming and costly process, especially for learning medical skills. In this Work in Progress, we address the problem of lacking suitable methodologies in the design and development processes of educational serious games for HE medical environments. Our proposal is a semi-formal and simple method to elicit and formalize the specific teaching needs identified in subjects or practices of Medicine degrees, in order to design and develop serious games based on sound educational principles and theories and on RE rules.

To estimate the cost-effectiveness of rosuvastatin versus simvastatin, atorvastatin and pitavastatin in Spain, according to the European guidelines for the treatment of dyslipidemias in patients with high and very high cardiovascular risk.A Markov long-term cost-effectiveness model of rosuvastatin versus simvastatin, atorvastatin and pitavastatin in patients with high and very high cardiovascular risk defined according to 5 factors (sex, age, smoking habit, baseline cholesterol level, and systolic blood pressure) using the SCORE system. The incremental cost-effectiveness ratio is expressed in euros per quality adjusted life years and is calculated according to the perspective of the Spanish National Health System.Rosuvastatin is associated with a greater health benefit than the other statins across the considered profiles. Rosuvastatin is cost-effective compared to simvastatin in patients with SCORE risk ≥8% in females and ≥6% in males, while between 5% and the indicated values its cost-effectiveness is conditional to the patient baseline c-LDL level. Rosuvastatin is more cost-effective versus atorvastatin in female profiles associated with a SCORE risk≥11% and male profiles with SCORE risk ≥10%. Rosuvastatin is superior versus pitavastatin in both female and male profiles with high and very high cardiovascular risk.Rosuvastatin is a cost-effective therapy in the treatment of hypercholesterolemia versus simvastatin, atorvastatin and pitavastatin, especially in specific profiles of patients with high and very high cardiovascular risk factors, according to the SCORE system, in Spain.

Introduction: Health-related quality of life (HRQoL) provides a global view of the state of health of a patient receiving home enteral nutrition (HEN). Objective: To evaluate the HRQoL of patients receiving HEN using the NutriQoL® questionnaire, a specifi c instrument regardless of the underlying disease and route of administration.Materials and methods: Observational, prospective and multicentre study conducted in the context of the validation and assessment of the NutriQoL® questionnaire’s psychometric properties.Results: One-hundred-and-forty individuals [disease: cancer (58.6%), malabsorption and other (27.1%), neurological (13.6%); HEN: supplement (61.4%), sole source of nutrition (35.7%); administration route: oral (54.3%), ostomy (31.4%), nasoenteric tube (12.1%)] participated. NutriQoL® was reliable [ICC: 0.88 (95%CI: 0.80-0.93); Cronbach’s α: 0.77 (1st visit) and 0.83 (2nd visit)], valid (signifi cant Rho), lowly sensitive to changes (effect size 0.23), can be completed by either patients or caregivers (ICC: 0.82). The mean HRQoL (SD) with NutriQoL® was 14.98 (14.86), EQ-5D tariff: 53(0.25), EQ-5D VAS: 54.15 (20.64) and COOP/WONCA charts: 23.32(5.66). HRQoL with NutriQoL® was better (p < 0.05) for oral HEN [19.54 (13,23)], than nasoenteric tube [14(11.71)], ostomy [7.02 (15.48)]; administered orally [19.54 (13.23)], than by gravity [10.97 (14.46)], pump [8.5 (19.78)] or syringe bolus [7 (11.40)]; as a supplement [19.33 (13.73)] instead of sole source of nutrition [8.18 (14.23)].Conclusions: NutriQoL® is valid, reliable, even if lowly sensitive to change, and useful to measure HRQoL in this population. More studies are needed to know HRQoL in routine practice.

About 40% of patients who receive oral anticoagulation would not start treatment with vitamin K antagonists due to the regular control they require and their interference with the diet and other concomitant medications.To analyze the preferences of patients with non valvular atrial fibrillation for oral anticoagulants (OAs) for the stroke prevention.Observational, multicentric study on preferences and maximum willingness to pay based on conjoint analysis: literature review, focus groups and semi-structured interviews with physicians and patients (n = 295) to define the attributes of OAs and their levels. Definition of scenarios that patients ordered according to their preferences. Clusters analysis to identify population groups by their preferences.Eight scenarios were defined based on five attributes: efficacy, security, a fixed dose, need for coagulation controls and interactions with diet and medication. The most preferred attribute was the smaller number of embolisms in a year (importance: 30.15%) followed by the fixed dose of the OA (25.45%) and the smaller number of intracranial hemorrhage in a year (21.57%). Three clusters population were identified. The maximum amount patients' were willingness to pay for the OA was 66.76 ± 54.64 euros (mean) per month.Efficacy and a fixed dose are the attributes of OA most valued by non valvular atrial fibrillation patients. There are groups of patients who differ in their preferences. This differences should be taken into account when deciding instauration or change on the OA treatment to ameliorate the accomplishment and prevention in this patients.

Background: In oncology, establishing the value of new cancer treatments is challenging. A clear definition of the different perspectives regarding the drivers of innovation in oncology is required to enable new cancer treatments to be properly rewarded for the value they create. The aim of this study was to analyze the views of oncologists, health care policy makers, patients, and the general population regarding the value of new cancer treatments. Methods: An exploratory and qualitative study was conducted through structured interviews to assess participants’ attitudes toward cost and outcomes of cancer drugs. First, the participants were asked to indicate the minimum survival benefit that a new treatment should have to be funded by the Spanish National Health System (NHS). Second, the participants were requested to state the highest cost that the NHS could afford for a medication that increases a patient’s quality of life (QoL) by twofold with no changes in survival. The responses were used to calculate incremental cost-effectiveness ratios (ICERs). Results: The minimum improvement in patient survival means that justified inclusions into the NHS were 5.7, 8.2, 9.1, and 10.4 months, which implied different ICERs for oncologists (€106,000/quality-adjusted life year [QALY]), patients (€73,520/QALY), the general population (€66,074/QALY), and health care policy makers (€57,471/QALY), respectively. The costs stated in the QoL-enhancing scenario were €33,167, €30,200, €26,000, and €17,040, which resulted in ICERs of €82,917/QALY for patients, €75,500/QALY for the general population, €65,000/QALY for oncologists, and €42,600/QALY for health care policy makers, respectively. Conclusion: All estimated ICER values were higher than the thresholds previously described in the literature. Oncologists most valued gains in survival, whereas patients assigned a higher monetary value to treatments that enhanced QoL. Health care policy makers were less likely to pay more for therapeutic improvements compared to the remaining participants, The study was funded by Eli & Lilly and Co

1. Garcia-Ruiz AJ et al. ISPOR 15th Annual European Congress (November, 2012), Berlin, Germany. 2. Clyde E and Markowitz MD. Am J Manag Care 2010; 16: s211-18. 3. Steinber SC et al. Clin Drug Investig 2010; 30(2):89-100. 4. Tan H, et al. Adv Ther 2011; 28(1):51-61.5. Ivanova JI et al. J Med Econ 2012; 15(3):601-9. 6. Oleen-Burkey et al. J Med Econ 2011; 14(6):739-47. 7. Verdun di Cantogno E et al. Patient Prefer Adherence 2011; 5:173-8.8. Swinburn P et al. ISPOR 17th Annual International Meeting (June, 2012), Washington DC, USA. Treatment adherence and costs in multiple sclerosis: a narrative review of the literature

El desarrollo de la medicina basada en la evidencia en las ultimas dos decadas ha traido consigo un aspecto habitualmente poco destacado por los expertos en la materia: se ha hecho un notable enfasis en encontrar y aplicar las mejores evidencias disponibles, pero mucho menos sobre otro tema crucial, el punto de vista de los pacientes. La importancia de la vision de los pacientes, lo que opinan, lo que sienten y experimentan con las actuaciones sanitarias y con los tratamientos aplicados, esta en el origen del cambio de la relacion medico-paciente. Si hace anos predominaba el modelo paternalista donde el medico se erigia como fuente unica de sabiduria y se acataban sus prescripciones y recomendaciones, hoy se tiende hacia un modelo de decisiones compartidas en que el paciente va cobrando protagonismo. A ello han contribuido tambien las escasas evidencias disponibles en muchas patologias y el problema de la variabilidad en la practica clinica. En este contexto, los clinicos consideran crucial contar con la opinion de sus pacientes. Una manera de conseguirlo es evaluando los resultados en salud percibidos y comunicados por el paciente de una manera objetiva, precisa y con rigor cientifico. Estos resultados (en terminologia anglosajona, patient-reported outcomes [PRO]) son valoraciones del propio paciente sobre su estado de salud y el

We intended to obtain reference population values of the COOP/WONCA charts of health-related quality of life (HRQOL) among a Spanish urban adult population.Cross sectional study based on data from the Survey of Health of the City of Madrid 2005. 7341 adults were selected by biphasic cluster sampling. The variable HRQOL was measured through COOP/WONCA charts of quality of life (9 dimensions), culturally validated for Spanish people. Other variables included age, sex, marital status, and social class, zone of origin and level of education. Statistical treatment included descriptive statistics for the dimensions and summation of HRQOL, significance tests (Kruskal-Wallis, Mann-Whitney, ANOVA), analysis of internal consistency and correlation.Highest mean values were found in the dimensions Changes in the State of Health, Health Status, Physical Form and Social Support. The average value of the dimensions and the summation of HRQOL increased significantly with age, and in parallel to a lowering of the social class and depending on the country of origin (higher in native people). They were also higher in women. The alpha of Cronbach for the questionnaire was 0.77.Reference population values were obtained for a Spanish urban adult population according to sex, age, social class and status of native or immigrant people. All ratings increased with age and were highest in women. The availability of benchmarks values contribute to the score' interpretation, which would ease the systematic use of tools of self-assessed health in clinical practice.

OBJECTIVE: To describe the initial treatment of patients >60 years who had subjective memory complaints and/or cognitive impairment for at least 6 months. DESIGN: Observational, longitudinal, multicentre, and naturalistic study, with a follow-up period of 12 months. SETTING: A total of 105 primary care centres. PARTICIPANTS: The study included 921 patients who attended a clinic. MAIN MEASUREMENTS: In the baseline visit, the social demographic characteristics, diagnosis, treatment, and the health care referrals were recorded, and in the next 2 (6 and 12 months) the diagnostic change, treatment, and referrals. RESULTS: The majority of subjects were female (66.9%) and the mean age was 74.3 ± 6.8 years. In the initial visit, 50.5% (95% confidence interval [CI], 47.3-53.7) of the diagnoses were classed as syndromic and 33.3% (95% CI, 30.3-36.3), aetiological. The primary care doctor modified an unconfirmed initial diagnosis in 22% (95% CI, 19.3-24.7) of the patients during the 12 months follow-up study. A diagnosis was made in 63.8% (95% CI, 60.7-66.9) of patients by anamnesis, physical examination, the screening test, and laboratory data. In the initial visit, el 52.6% (95% CI, 49.4-55.8) received treatment of mainly nootropics and neuroprotectors, and later, the percentage of patients on cholinesterase inhibitors increased. The primary care doctor referred 54.9% (95% CI, 51.7-58.1) of the patients during the 12 months of the study. CONCLUSIONS: The primary care doctor diagnoses the majority of patients with the means available, mainly based on anamnesis, examination, the screening test, and laboratory data. They prescribe drugs that lack efficacy for this disease and few of those that have been shown to be effective.

Understanding the epidemiology of moderate-to-severe psoriasis is essential for its management.To assess the epidemiological characteristics of patients with moderate-to-severe psoriasis.Cross-sectional, observational epidemiological study conducted in Spain and Portugal. Data were collected by 332 dermatologists foror=10 consecutive presenting patients.Based on body surface area (BSA) and Psoriasis Area and Severity Index (PASI) criteria, moderate-to-severe psoriasis was confirmed inor=79.3% of patients (n = 3,320). Preexisting comorbid conditions included psoriatic arthropathy (13%), dyslipidemia (14.1%) and hypertension (20.2%). The mean BSA involvement was 23% (95% confidence interval, CI: 22.2-23.3%), and the mean PASI score was 14.3 (95% CI: 13.9-14.6%). During the 2 years prior to assessment, 97.0% of patients had received topical treatments, whereas 31.3% had not received systemic treatment or phototherapy. The median annual cost of treatment was 825 EUR.Moderate-to-severe psoriasis is accurately diagnosed, but inadequately treated in many patients in Spain and Portugal.

Different studies have reported of physical, social and psychological disadvantages in patients with psoriasis. Nevertheless, its impact on the health-related quality of life is not clarified sufficiently. Our objective is to know the repercussion of the moderate-severe psoriasis on the health-related quality of life with the Psoriasis Disability Index (PDI).An observational, cross-sectional, international study developed in dermatology practices in Spain and Portugal. During a period of 9 months, 332 participating dermatologist included a minimum of 10 consecutive patients with moderate to severe psoriasis. The date report form includes information about the health-related quality of life (PDI), as well as objective variables of severity as body surface area and PASI (Psoriasis Area and Severity Index), pruritus, costs and willingness to pay.A total of 3,320 patients were assessed. The majority of cases were males (57%) and the mean age at study inclusion time was 47 years. The mean value of the PDI was 8.93 (95% confidence interval, 7.83-9.21), which represents a percentage of global disability lower than 20%. The floor effect varies between 8.3% and 61.2%, and the ceiling effect varies between 0% and 3%. The correlations between the PDI and objective variables of severity (PASI and body surface area) were weak though statistically significant (p0.001) They all indicate that to higher severity of the psoriasis, upper negative impact in the health-related quality of life.Psoriasis causes a negative impact in the health-related quality of life, though the magnitudes are weak and suggest some problems with the questionnaire. Possibly, the PDI reflects more the disability that the form in which the patients perceive and react to their state of health, and, several items seem to have a scanty applicability in the Spanish and Portuguese population. The PDI doesn't seem the appropriate instrument for this type of patients in our environment.

Carlos Morillas,1 Rosa Feliciano,2 Pablo Fernández Catalina,3 Carla Ponte,4 Marta Botella,5 João Rodrigues,6 Enric Esmatjes,7 Javier Lafita,8 Luis Lizán,9 Ignacio Llorente,10 Cristóbal Morales,11 Jorge Navarro-Pérez,12 Domingo Orozco-Beltran,13 Silvia Paz,9 Antonio Ramirez de Arellano,14 Cristina Cardoso,15 Maribel Tribaldos Causadias9 1Hospital Universitario Dr Peset, Valencia, Spain; 2USF São Domingos, Santarém, Portugal; 3Hospital Montecelo de Pontevedra, Galicia, Spain; 4USF Porta do Sol, Matosinhos, Portugal; 5Hospital Universitario Principe de Asturias, Madrid, Spain; 6USF Serra da Lousã, Lousã, Portugal; 7Hospital Clinic, Barcelona, Spain; 8Hospital de Navarra, Navarra, Spain; 9Outcomes’10, Universidad Jaume I, Castellón, Spain; 10Hospital Universitario Nuestra Señora de la Candelaria, Canarias, Spain; 11Hospital Universitario Virgen de la Macarena, Sevilla, Spain; 12INCLIVA, CIBERESP, Universidad de Valencia, Valencia, Spain; 13Sociedad Española de Medicina Familiar y Comunitaria, Valencia, Spain; 14Novo Nordisk EU-HEOR Europe, Madrid, Spain; 15Novo Nordisk, Lisbon, Portugal Objective: To assess Spanish and Portuguese patients’ and physicians’ preferences regarding type 2 diabetes mellitus (T2DM) treatments and the monthly willingness to pay (WTP) to gain benefits or avoid side effects.Methods: An observational, multicenter, exploratory study focused on routine clinical practice in Spain and Portugal. Physicians were recruited from multiple hospitals and outpatient clinics, while patients were recruited from eleven centers operating in the public health care system in different autonomous communities in Spain and Portugal. Preferences were measured via a discrete choice experiment by rating multiple T2DM medication attributes. Data were analyzed using the conditional logit model.Results: Three-hundred and thirty (n=330) patients (49.7% female; mean age 62.4 [SD: 10.3] years, mean T2DM duration 13.9 [8.2] years, mean body mass index 32.5 [6.8] kg/m2, 41.8% received oral+ injected medication, 40.3% received oral, and 17.6% injected treatments) and 221 physicians from Spain and Portugal (62% female; mean age 41.9 [SD: 10.5] years, 33.5% endocrinologists, 66.5% primary-care doctors) participated. Patients valued avoiding a gain in bodyweight of 3 kg/6 months (WTP: €68.14 [95% confidence interval: 54.55–85.08]) the most, followed by avoiding one hypoglycemic event/month (WTP: €54.80 [23.29–82.26]). Physicians valued avoiding one hypoglycemia/week (WTP: €287.18 [95% confidence interval: 160.31–1,387.21]) the most, followed by avoiding a 3 kg/6 months gain in bodyweight and decreasing cardiovascular risk (WTP: €166.87 [88.63–843.09] and €154.30 [98.13–434.19], respectively). Physicians and patients were willing to pay €125.92 (73.30–622.75) and €24.28 (18.41–30.31), respectively, to avoid a 1% increase in glycated hemoglobin, and €143.30 (73.39–543.62) and €42.74 (23.89–61.77) to avoid nausea.Conclusion: Both patients and physicians in Spain and Portugal are willing to pay for the health benefits associated with improved diabetes treatment, the most important being to avoid hypoglycemia and gaining weight. Decreased cardiovascular risk and weight reduction became the third most valued attributes for physicians and patients, respectively. Keywords: diabetes, discrete choice model, preferences, willingness to pay, hypoglycemia, weight, cardiovascular risk, HbA1c

To assess the measurement properties of the Spanish version of the Psoriasis Disability Index (PDI) quality of life questionnaire for patients with moderate or severe psoriasis in ordinary clinical practice.A study was carried out with 294 patients with moderate or severe psoriasis who had received therapeutic treatment. Sociodemographic and clinical variables were collected and the PDI and EuroQoL-5D questionnaires were administered at the baseline visit, and at 3 and 6 months later. The feasibility (percentage of patients responding to the questionnaire), validity of the construct, internal reliability and sensitivity to change were analyzed.Feasibility: 98.6 % of the patients answered over 80 % of the questions on the questionnaire. Validity of the construct: the PDI scores were correlated with the scores obtained in the Psoriasis Area Disability Index (PASI) (r = 0.33) and the Visual Analogue Scale (VAS) of the EQ-5D (r = -0.41) (p0.01). Longitudinal validity: the PDI questionnaire score after 6 months of treatment was correlated with the changes in the PASI index and the VAS (r = 0.39 y -0.51). Reliability: the internal consistency of the dimensions was high (Cronbach's alpha = 0.89). Sensitivity to changes: the size of the effect corresponding to the changes experienced by the patients who noticed an improvement in the severity of their psoriasis during the period between visits was 0.95.The Spanish version of the PDI has proven to be reliable, valid and sensitive to changes for use with patients with psoriasis in the Spanish population, although the test-retest reliability should be analyzed for clinically stable patients.

ObjetivoEvaluar la eficiencia de paracetamol, indicado como tratamiento de primera línea para el dolor entre leve y moderado de la artrosis de cadera y rodilla, frente a rofecoxib, el inhibidor de la COX-2 más utilizado en EspañaDiseñoModelo farmacoeconómico: análisis de minimización de costes basado en la información proporcionada por la revisión sistemática de la bibliografíaEmplazamientoNacional. EspañaParticipantesPacientes con diagnóstico de artrosis de rodilla o cadera, con dolor entre leve y moderado, que demandan atención sanitaria en los servicios de atención primaria y que no presentan contraindicación para los tratamientos evaluadosMediciones principalesAnte el supuesto de una eficacia equivalente entre paracetamol y rofecoxib, el modelo de minimización de costes se centró en el coste originado por la presencia de efectos adversos con cada fármaco tras aplicar un factor de corrección proporcional al número de sujetos incluidos en los estudios revisados y al número de efectos adversos observadoResultadosEl paracetamol minimiza los costes a los 3 meses y a 1 año respecto a rofecoxib. El coste anual promedio de paracetamol es de 307,95 euros (rango, 301,57–315,12) frente a los 574,59 euros (rango, 566,74–580,40) del tratamiento con rofecoxib. El principal inductor de costes tras el análisis de sensibilidad fue el coste de adquisición de los medicamentos, más que la tasa de incidencia de los efectos adversosConclusionesEl paracetamol es la primera opción de tratamiento frente a rofecoxib en el dolor artrósico entre leve y moderado desde el punto de vista del análisis económico basado en la minimización de costes, lo que confirma las recomendaciones que, con criterios de eficacia y seguridad, se indican en diversas guías de práctica clínica vigentesObjectiveTo assess the efficiency of paracetamol, indicated in first instance for light-to-moderate pain from hip and knee arthrosis, against rofecoxib, the COX-2 inhibitor most commonly used in SpainDesignPharmaco-economic model: costminimisation analysis based on the information provided by a systematic review of the literatureSettingSpain: statewideParticipantsPatients with a diagnosis of knee or hip arthrosis, who demand health-care for light-to-moderate pain in the primary care services and present no counter-indication to the treatments under evaluationMain measurementsGiven the supposition of the equivalent efficacy of paracetamol and rofecoxib, the cost-minimisation model focused on the cost arising from the adverse side effects caused by the 2 drugs. A correction factor allowed for the number of subjects in the studies reviewed and the number of adverse side effects foundResultsParacetamol was cheaper than rofecoxib at both 3 months and 1 year. The average cost of paracetamol per year was z.euro;307.95 (301.57–315.12) versus z.euro;574.59 (566.74–580.40) for rofecoxib treatment. The main cause of costs after the sensitivity analysis was the cost of acquiring the drugs, rather than the rate of incidence of adverse side effectsConclusionsIn terms of economic analysis based on cost minimisation, paracetamol was the first-preference treatment over rofecoxib for light-to-moderate arthrosis pain. This confirmed the recommendations which, under efficacy and safety criteria, are indicated in various clinical practice guidelines in force

Background Despite the wide use of the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) in a clinical setting to assess agitated patients, a validation study to evaluate its psychometric properties was missing. Methods Data from the observational NATURA study were used. This research describes trends in the use of treatments in patients with acute psychotic episodes and agitation seen in emergency departments. Exploratory principal component factor analysis was performed. Spearman's correlation and regression analyses (linear regression model) as well as equipercentile linking of Clinical Global Impression of Severity (CGI-S), Agitation and Calmness Evaluation Scale (ACES) and PANSS-EC items were conducted to examine the scale's diagnostic validity. Furthermore, reliability (Cronbach's alpha) and responsiveness were evaluated. Results Factor analysis resulted in one factor being retained according to eigenvalue ≥1. At admission, the PANSS-EC and CGI-S were found to be linearly related, with an average increase of 3.4 points (p < 0.001) on the PANSS-EC for each additional CGI-S point. The PANSS-EC and ACES were found to be linearly and inversely related, with an average decrease of 5.5 points (p < 0.001) on the PANSS-EC for each additional point. The equipercentile method shows the poor sensitivity of the ACES scale. Cronbach's alpha was 0.86 and effect size was 1.44. Conclusions The factorial analyses confirm the unifactorial structure of the PANSS-EC subscale. The PANSS-EC showed a strong linear correlation with rating scales such as CGI-S and ACES. PANSS-EC has also shown an excellent capacity to detect real changes in agitated patients.

Objetivo Evaluar la efectividad clinica de un programa de automanejo de la artrosis en pacientes de atencion primaria. Diseno Ensayo clinico aleatorizado y controlado. Emplazamiento Un total de 74 consultas de atencion primaria en el Reino Unido. Poblacion Se incluyeron en el estudio, y se efectuo un seguimiento durante 12 meses, a 812 pacientes de 50 anos o mas con diagnostico de artrosis de rodilla, cadera o ambas, durante al menos un ano, y con dolor, limitacion funcional o ambos durante el mes previo. Se excluyo a los pacientes con indicacion de intervencion quirurgica, con escasa movilidad, que no comprendian el idioma ingles o que presentaban un deterioro cognitivo. Intervencion Un programa norteamericano para el automanejo de la artrosis se adapto para ser utilizado en el Reino Unido. Este programa esta basado en la teoria cognitiva social: un mayor conocimiento acerca de la enfermedad y su automanejo deben proporcionar efectos beneficiosos y una autopercepcion mas positiva sobre el control de la enfermedad. Un total de 812 pacientes fueron aleatoriamente asignados a recibir 6 sesiones del programa de automanejo junto con un manual educativo (grupo de intervencion, n = 406) o a recibir solo un manual educativo (grupo control, n = 406). No completaron el estudio112 pacientes del grupo intervencion y 81 del grupo control. Medicion del resultado La variable principal de estudio fue la calidad de vida relacionada con la salud medida con el SF-36. La segunda variable mas importante fue el automanejo de la enfermedad con la Arthritis Self Efficacy (ASE) Scale. El dolor, la rigidez articular y la funcionalidad fisica se midieron con el WOMAC Ostheoarthritis Index, y la ansiedad y depresion se evaluaron con la Hospital Anxiety and Depresion (HAD) Scale. Se empleo un cuestionario que los pacientes cumplimentaron al inicio (basal), a los 4 y a los 12 meses de seguimiento. Se realizo un analisis por intencion de tratar de todas las variables consideradas, y ademas un analisis por protocolo de los pacientes que habian asistido a 4 (considerado el minimo numero de asistencias clinicamente significativo) o mas sesiones del programa educativo. Resultados principales No se hallaron diferencias significativas entre los 2 grupos en la variable principal, aunque los parametros de salud mental medidos con el SF-36 tendieron a mejorar en el grupo de intervencion. Tampoco hubo diferencias significativas en los 3 componentes del WOMAC, aunque en el grupo de intervencion todos los parametros tendieron a mejorar, especialmente a los 12 meses de seguimiento. En el grupo de intervencion, la ansiedad se redujo significativamente a los 12 meses (–0,62; intervalo de confianza [IC] del 95%, –1,08 a –0,16), asi como la depresion medida a los 4 meses (–0,40; IC del 95%, –0,76 a –0,03), aunque esta ultima tendencia se perdio al ano. El dolor se redujo significativamente a los 4 meses (1,63; IC del 95%, 0,83-2,43) y a los 12 meses (0,98; IC del 95%, 0,07-1,89). Los resultados del analisis por protocolo fueron similares a los obtenidos con el analisis por intencion de tratar. Conclusion El programa de automanejo de la artrosis reduce la ansiedad y mejora la percepcion de los pacientes sobre su capacidad de automanejo de los sintomas. No modifica el dolor o la funcionalidad fisica