Cost-utility analysis of certolizumab pegol versus alternative tumour necrosis factor inhibitors available for the treatment of moderate-to-severe active rheumatoid arthritis in Spain.

BACKGROUND: Certolizumab pegol, a PEGylated tumour necrosis factor (TNF)-inhibitor, improves the clinical signs and symptoms of rheumatoid arthritis (RA) when used in combination with methotrexate or as monotherapy. This study evaluatedthe cost-utility of certolizumab pegol versusTNF-inhibitors plus methotrexate in the treatment of moderate-to-severe RA in Spain. METHODS: A Markov cohort health state transition model was developed to evaluate the cost-utility (costs and quality-adjusted life years [QALYs]) of certolizumab pegol versus other TNF-inhibitors licensed in Spain in 2009. Efficacy was measured using the American College of Rheumatology (ACR) responses at 6 months, based on adjusted indirect comparisons from published clinical trials. Utilities were derived from EQ-5D data from certolizumab pegol RA clinical trials. Clinical history and resource use data came from published literature. Unit costs were taken from Spanish databases or published data (cost year 2009). Base case analyses were conducted from the payer perspective, with a lifetime horizon, 3.5 % annual discounting rates for costs and outcomes, and 3 % inflation rate for 2009 onwards. One-way sensitivity analyses were conducted. RESULTS: The average lifetime costs for certolizumab pegol, etanercept, adalimumab (every 2 weeks and weekly) and infliximab (3 mg/kg and 5 mg/kg) in combination with methotrexate were €140,971, €141,197, €139,148, €164,741, €136,961 and €152,561, respectively. The QALYs gained were 6.578, 6.462, 6.430 (for both adalimumab doses), 6.430, and 6.318 (for both infliximab doses), respectively. At a €30,000/QALY willingness-to-pay threshold, certolizumab pegol plus methotrexate dominated adalimumab weekly, etanercept, and infliximab 5 mg/kg, and was cost-effective versus adalimumab every 2 weeks and infliximab 3 mg/kg (all with methotrexate), with estimated ICERs of €12,346/QALY and €15,414/QALY, respectively. Certolizumab pegol monotherapy was more cost-effective versus adalimumab, and less expensive with similar health gains versus etanercept (6.416 QALYs vs 6.492). Univariate analysis showed ICERs to be sensitive to changes in time horizon, ACR response time point, baseline Heath Assessment Questionnaire (HAQ) score, and rate of HAQ-disability index deterioration after discontinuing treatment. CONCLUSIONS: This analysis shows that certolizumab pegol is cost-effective compared with other TNF-inhibitors recommended in Spain for the treatment of RA.

(18)F-fluorodeoxyglucose positron emission tomography/computed tomography accuracy in the staging of non-small cell lung cancer: review and cost-effectiveness.

Aim of the performed clinical study was to compare the accuracy and cost-effectiveness of PET/CT in the staging of non-small cell lung cancer (NSCLC). Material and Methods. Cross-sectional and prospective study including 103 patients with histologically confirmed NSCLC. All patients were examined using PET/CT with intravenous contrast medium. Those with disease stage ≤IIB underwent surgery (n = 40). Disease stage was confirmed based on histology results, which were compared with those of PET/CT and positron emission tomography (PET) and computed tomography (CT) separately. 63 patients classified with ≥IIIA disease stage by PET/CT did not undergo surgery. The cost-effectiveness of PET/CT for disease classification was examined using a decision tree analysis. Results. Compared with histology, the accuracy of PET/CT for disease staging has a positive predictive value of 80%, a negative predictive value of 95%, a sensitivity of 94%, and a specificity of 82%. For PET alone, these values are 53%, 66%, 60%, and 50%, whereas for CT alone they are 68%, 86%, 76%, and 72%, respectively. Incremental cost-effectiveness of PET/CT over CT alone was €17,412 quality-adjusted life-year (QALY). Conclusion. In our clinical study, PET/CT using intravenous contrast medium was an accurate and cost-effective method for staging of patients with NSCLC.

Cirugía abierta vs. laparoscópica: calidad de vida y sintomatología ansioso-depresiva en cáncer colorrectal / Laparoscopic vs. open surgery: quality of life and anxious-depressive symptomatology in colorectal cancer

Introducción: El objetivo del presente estudio es evaluar la calidad de vida, y la sintomatología ansioso-depresiva, en una muestra de pacientes de cáncer colorrectal sometidos a tratamiento quirúrgico, por vía abierta o laparoscópica. Material y Métodos: 60 pacientes fueron evaluados en Calidad de vida, mediante el cuestionario de la EORTC QLQ-C30, y sintomatología ansioso-depresiva mediante la escala de Ansiedad y Depresión Hospitalaria (HADS). Además se realizaron análisis en función de tres variables sociodemográficas: edad, género y nivel socioeducativo. Resultados: No se encontraron diferencias significativas en función de la modalidad quirúrgica en calidad de vida y sintomatología ansioso-depresiva. La mayor parte de los pacientes presenta niveles de calidad de vida muy satisfactorios, si bien un 27% presentan problemas de calidad de vida. Las medias en sintomatología ansioso-depresiva se encuentran en los rangos normales, no obstante el 18% presenta sintomatología depresiva y el 22% ansiosa. Discusión y Conclusiones: Se puede concluir que los dos tipos de cirugía, a medio y largo plazo, tienen efectos similares sobre la calidad de vida y la sintomatología ansioso-depresiva de los pacientes. No obstante, aun estando libres de tratamiento activo y habiendo transcurrido más de un año de media desde la cirugía, se ha encontrado que hay pacientes que presentan problemas en su calidad de vida, y sintomatología ansioso-depresiva. Por ello es necesario que éstos sean evaluados psicológicamente para prestarles la atención necesaria, y así optimizar la calidad asistencial.

Background: The aim of this study was to assess the quality of life, and anxious-depressive symptoms in a sample of colorectal cancer patients undergoing surgical treatment, open or laparoscopic approach. Material and Method: 60 patients were assessed on quality of life, through the questionnaire of the EORTC QLQ-C30, and anxious-depressive symptomatology scale by Hospital Anxiety and Depression (HADS). Further analyzes were conducted according to three demographic variables: age, gender and socio-educational level. Results: No significant differences were found related to surgical type in quality of life and anxious-depressive symptomatology. Most of the patients have very satisfactory quality of life levels, while 27% of them have problems about it. Means in anxious-depressive symptoms are at normal range, despite of 18% whom presented depressive symptoms and 22% anxiety. Conclusion: It can be concluded that the two types of surgery, in a medium and long term, have similar effects on quality of life and anxious-depressive symptoms of patients. However, even free of active treatment and over a year after surgery, we found that there are patients who have problems in their quality of life and anxious-depressive syndrome. Therefore it is necessary to evaluate and to give them the attention needed and optimize quality of care.

Cost-effectiveness analysis of 64-slice computed tomography vs. cardiac catheterization to rule out coronary artery disease before non-coronary cardiovascular surgery.

AIMS: To explore the cost-effectiveness of two alternative strategies to rule out significant coronary artery disease (CAD) in the pre-operative evaluation of non-coronary cardiovascular surgery: initial pre-operative coronary 64-slice computed tomography angiography (CCTA) vs. invasive coronary angiography (ICA). METHODS AND RESULTS: These diagnostic strategies are compared from the clinical and payee's perspective, on the basis of the results of four European studies including 490 patients, by an analytic model of a decision tree in terms of the cost-effectiveness as the percentage of catheterizations, complications, and deaths avoided. These studies show that 71.2% of the ICA and 3.56% of the post-ICA complications could have been avoided by an initial pre-operative CCTA with a saving of €411/patient. The sensitivity analysis did not find relevant differences in terms of the cost-effectiveness when we established the indication of ICA vs. CCTA in relation to the amount of coronary calcium and when ICA was always performed by radial access. However, the lack of team experience in CCTA increased the economical and biological cost due to involving an ICA and the exposure to double ionizing radiation sources. CONCLUSION: In experienced groups, the diagnostic strategy with initial pre-operative CCTA is better than the strategy with initial ICA because it is capable of ruling out significant CAD avoiding ICA and post-ICA morbidity-mortality, with an important saving in the cost of the diagnostic process.

The IRYSS-COPD appropriateness study: objectives, methodology, and description of the prospective cohort.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) often experience exacerbations of the disease that require hospitalization. Current guidelines offer little guidance for identifying patients whose clinical situation is appropriate for admission to the hospital, and properly developed and validated severity scores for COPD exacerbations are lacking. To address these important gaps in clinical care, we created the IRYSS-COPD Appropriateness Study. METHODS/DESIGN: The RAND/UCLA Appropriateness Methodology was used to identify appropriate and inappropriate scenarios for hospital admission for patients experiencing COPD exacerbations. These scenarios were then applied to a prospective cohort of patients attending the emergency departments (ED) of 16 participating hospitals. Information was recorded during the time the patient was evaluated in the ED, at the time a decision was made to admit the patient to the hospital or discharge home, and during follow-up after admission or discharge home. While complete data were generally available at the time of ED admission, data were often missing at the time of decision making. Predefined assumptions were used to impute much of the missing data. DISCUSSION: The IRYSS-COPD Appropriateness Study will validate the appropriateness criteria developed by the RAND/UCLA Appropriateness Methodology and thus better delineate the requirements for admission or discharge of patients experiencing exacerbations of COPD. The study will also provide a better understanding of the determinants of outcomes of COPD exacerbations, and evaluate the equity and variability in access and outcomes in these patients.

Health technology assessment-based development of a Spanish breast cancer patient decision aid.

OBJECTIVES: The aim of this study was to develop a breast cancer Patient Decision Aid (PDA), using a Health Technology Assessment (HTA) process, to assist patients in their choice of therapeutic options, and to promote shared decision making among patients, healthcare professionals, and other interested parties. METHODS: A systematic review (SR) was conducted of existing breast cancer patient Decision Aids encountered in the main scientific journal databases and on institutional Web sites that create PDAs, together with a Qualitative Research (QR) study, using semi-structured interviews and focus group with stakeholders (patients, family members, and health professionals), with the aim of developing a PDA for breast cancer. RESULTS: The SR shows that PDAs in breast cancer not only increase patient knowledge of the illness, leading to more realistic expectations of treatment outcomes, but also reduce passivity in the decision-making process and facilitate the appropriate choice of treatment options in accordance with patient medical and personal preferences. The analysis of QR shows that both breast cancer patients and healthcare professionals agree that surgery, adjuvant treatments, and breast reconstruction represent the most important decisions to be made. Worry, anxiety, optimism, and trust in healthcare professionals were determined as factors that most affected patients subjective experiences of the illness. This HTA was used as the basis for developing a PDA software program. CONCLUSIONS: The SR and QR used in the development of this PDA for breast cancer allowed patients to access information, gain additional knowledge of their illness, make shared treatment decisions, and gave healthcare professionals a deeper insight into patient experiences of the disease.

Herramientas de ayuda a la toma de decisiones en cáncer colorrectal: una revisión / Pacient decision aids in colorectal cancer: A review

Objetivo: El objetivo de este trabajo es conocer los estudios publicados es los diez últimos años sobre la utilización de herramientas de ayuda a la toma de decisiones en pacientes con cáncer colorrectal, en cualquiera de las fases de la enfermedad. Así como localizar las herramientas de ayuda a la toma de decisiones que están disponibles. Método: Se ha realizado una revisión de la literatura desde el 2000 hasta el 2010 en las bases MEDLINE, PsycINFO, EMBASE y Cochrane. Así como una búsqueda en páginas webs de distintas organizaciones para la localización de herramientas disponibles Resultados: Una vez realizada la selección de los artículos, se contó con 10 artículos que presentan herramientas, evalúan las preferencias de los pacientes a la hora de tomar decisiones, evalúan las estrategias de distribución de dichas herramientas o se evalúa la forma más eficaz de presentar la información en las herramientas. A través de la búsqueda realizada mediante las páginas webs de las organizaciones se encontraron seis herramientas propiamente dichas sobre el cribado de cáncer colorrectal. Conclusiones: cada vez es mayor el interés por implicar al paciente en la toma de decisiones con respecto al cáncer colorrectal. Para ello se hace necesaria la evaluación de las preferencias y valores de los pacientes y por eso el uso de herramientas de ayuda a la toma de decisiones puede ayudar a los profesionales en esa evaluación y a los pacientes, además de a tomar la decisión, a sentirse satisfecho con ella (AU)

Aim: The objective is to collect available patient decision aids (PDA) for colorectal cancer in any of the stages of the disease and to gather published studies about the use of these tools in the last ten years Methods: A systematic review (SR) of tools for Decision-making Aid in colorectal cancer was performed since year 2000. Search includes main databases (MEDLINE, PsycINFO, EMBASE, Cochrane) as well as websites of institutions working with PDAs to search available tools. Results: After the appraisal of the found articles, we finally selected 10 studies with PDA for colorectal cancer in which patients preferences in the decision making process, disseminating strategies of the tools or the way of presenting patient information were assessed. Through the websites of institutions working with PDAs we found six tools about screening in colorectal cancer. Conclusions: There is a growing interest to involve patients with colorectal cancer in the decision making process. To do so, it’s necessary to assess patients’ values and preferences and that’s why PDAs are effective in helping both, professionals and patients. They are useful for professionals for this assessment process, and also for patients, not just to make a decision but also for being satisfied with the final decision (AU)

Variability in the prioritization of patients for cataract extraction.

OBJECTIVE: The aim of this study was to compare time spent waiting for cataract extraction across various hospitals and to determine if it was influenced by severity of disease or patient characteristics. DESIGN: Ambispective cohort study. Clinical, sociodemographic, and health-related quality of life data were collected along with time spent on the waiting list. SETTING: Twelve hospitals in four regions of Spain. PARTICIPANTS: A total of 4043 patients who were waiting for being intervened on cataracts in the participant centres were recruited prospectively. Exposition variables Priority was assigned retrospectively using a previously validated scoring system. MAIN OUTCOME MEASURE: Time spent on waiting list. RESULTS: Statistically significant differences in time spent on the waiting list (P < 0.0001) were observed across the hospitals, even after adjusting for pathology, age, social dependency, laterality of the cataract and number of inappropriate interventions in each centre. Waiting time was not correlated with preintervention visual acuity, preintervention visual function measured by the VF-14 or priority score. CONCLUSIONS: Allocation of cataract surgery does not appear to be correlated with the need for surgery or the likely benefit to be derived from it in the Spanish participant centres. The use of explicit and standardized priority criteria could provide a fairer, more rational way to manage waiting lists for this procedure and may help to reduce unnecessary variation on access to health care.

Can an appropriateness evaluation tool be used to prioritize patients on a waiting list for cataract extraction?

OBJECTIVES: To determine whether a system originally developed to ascertain the appropriateness of cataract intervention may also be used to prioritize patients on cataract extraction waiting lists. METHODS: The IRYSS-appropriateness of indication for cataract surgery tool and the IRYSS-Cataract Priority Score were applied to a sample of 5448 patients consecutively placed on waiting lists for cataract surgery. Clinical data were gathered by ophthalmologists, and patients self-completed the Visual Function Index-14. The general linear model (GLM) was used to assign scores to the categories of the appropriateness and priority criteria. The relationship between both systems was evaluated by correlating scores. To assess the validity of the new appropriateness and priority scores, correlations with visual acuity (VA) and visual function were calculated. RESULTS: The GLM method generated highly similar scores for both appropriateness and prioritization systems. The correlation between scores was very strong (r=0.96). The appropriateness scoring system correlated 0.29 with VA and 0.21 with gain in visual function. The priority system correlated -0.54 with VA and -0.28 with preintervention visual function. CONCLUSIONS: The new appropriateness scoring system strongly correlates with the priority scoring system. This easy-to-use appropriateness rating could serve as a tool for simultaneously assessing the appropriateness of cataract surgery and assigning priority.

Appropriateness of phacoemulsification in Spain.

OBJECTIVE: To evaluate the appropriateness of phacoemulsification procedures performed in four Spanish regions, applying criteria developed by means of RAND/UCLA methodology. DESIGN: Prospective observational study. SETTING: Seventeen public teaching hospitals in four regions of Spain. PARTICIPANTS: Patients on waiting list to undergo cataract extraction by phacoemulsification. INTERVENTION: Cataract surgery by phacoemulsification. MAIN OUTCOME MEASURE: Level of appropriateness of each intervention, according to criteria developed by means of the RAND/UCLA appropriateness methodology. RESULTS: Among the 5442 analysed patients the indication of phacoemulsification was appropriate in 69.6%, inappropriate in 7.3% and uncertain in 23.0%. Presence of ocular comorbidity, lack of cataract-induced visual function limitation, anticipated postoperative visual acuity of <0.5, preoperative visual acuity of >0.1 and high surgical complexity were associated with inappropriateness. CONCLUSIONS: Some clinical characteristics, when present, make it especially important to obtain a careful assessment of the risks and benefits of surgery. Consideration of these characteristics may improve the appropriateness of phacoemulsification.

A content analysis of Health Technology Assessment programs in Latin America.

OBJECTIVES: Health Technology Assessment (HTA) is a relatively new concept in Latin America (LA). The objectives of this exploratory study were to identify HTA programs in LA, review HTA documents produced by those programs, and assess the extent to which HTA aims are being achieved. METHODS: An electronic search through two databases was performed to identify HTA programs in LA. A content analysis was performed on HTA documents (n = 236) produced by six programs between January 2000 and March 2007. Results were analyzed by comparing document content with the main goals of HTA. RESULTS: The number of HTA documents increased incrementally during the study period. The documents produced were mostly short HTA documents (82 percent) that assessed technologies such as drugs (31 percent), diagnostic and/or screening technologies (18 percent), or medical procedures (18 percent). Two-thirds (66 percent) of all HTA documents addressed issues related to clinical effectiveness and economic evaluations. Ethical, social, and/or legal issues were rarely addressed (<1 percent). The two groups most often targeted for dissemination of HTA information were third-party payers (55 percent) or government policy makers (41 percent). CONCLUSIONS: This study showed that while HTA programs in LA have attempted to address the main goals of HTA, they have done so through the production of short documents that focus on practical high-technology areas of importance to two specific target groups. Clinical and economic considerations still take precedence over ethical, social, and/or legal issues. Thus, an integrated conceptual framework in LA is wanting.

Defining products for a new health technology assessment agency in Madrid, Spain: a survey of decision makers.

OBJECTIVES: The aim of this study was to explore the needs and requirements of decision makers in our regional healthcare system for health technology assessment (HTA) products to support portfolio development planning for a new HTA agency in Madrid, Spain. METHODS: A Delphi study was conducted during 2003. Questionnaires were developed based on a review of products and services offered by other agency members of the International Network of Agencies for Health Technology Assessment, and included preference and prioritization questions to evaluate twenty-two different products and services. The initial Delphi panel involved eighty-seven experts from twenty-one public hospitals, eleven primary healthcare centers, six private hospitals, and eight departments of the Regional Ministry of Health of the Community of Madrid. RESULTS: The global participation rate was 83.9 percent. Ten of the twenty-two possible products were rated of high interest by more than 80 percent of respondents. Important differences in preferences and priorities were detected across different settings. Public hospitals and primary healthcare centers shared a more "micro" perspective, preferring classic technology-centered HTA products, whereas private hospitals and Ministry representatives demanded more "macro" products and services such as organizational model and information system assessments. CONCLUSIONS: The high participation rate supports the representativeness of the results for our regional context. The strategic development of an HTA portfolio based on decision makers' needs and requirements as identified in this type of exercise should help achieve a better impact on policy development and decision making.

[Non-occupational post-exposure HIV prophylaxis. Knowledge and practices among physicians and groups with risk behavior]. / Profilaxis postexposición al virus de la inmunodeficiencia humana no ocupacional. Conocimientos y prácticas de profesionales y grupos con conductas de riesgo.

BACKGROUND AND OBJECTIVE: Although occupational post-exposure HIV prophylaxis is widely admitted and used, the non-occupational post-exposure prophylaxis (NONOPEP) is controversial. Prevention of mother-to-child HIV transmission, experimental studies in animal models and retrospective studies in health workers, along with biological plausibility, would justify the use of NONOPEP in certain circumstances. Our objectives were: 1) To review the existence of recommendations; 2) To describe the attitudes, knowledge and practices of the professionals involved in the attention of non-occupational exposures to HIV; 3) To describe the attitudes and knowledge on such a prophylaxis by people with risk behaviours (homosexual men and intravenous drug users (IDU)); and 4) To describe the NONOPEP-related responses of telephone services of public attention on AIDS. SUBJECTS AND METHOD: Descriptive study by means of a survey of each defined target population between September 1999 and July 2000, using self-administered questionnaires and personal interviews. Structured and simulated interviews were used to survey the telephone services. RESULTS: To date, no official recommendations exist. 84% (97/116) of consulted doctors have taken care of some of non-occupational accidental exposure to HIV over the last six months. 77% (75/97) have prescribed NONOPEP, and 76% of doctors prescribing NONOPEP (57/75) have used the 1998 CDC recommendations for occupational exposures. Most frequent observed cases were related to needle sticks in the street and preservative breakage. The assessment of certain risk factors and therapeutic performance in cases of intermediate risk showed discrepancies among doctors. 41% (103/252) among homosexuals and 2% (3/160) among IDU on treatment know the NONOPEP. 15% (15/98) and 98% (70/118) respectively would take less prevention to avoid HIV infection if they took the NONOPEP. It was mentioned the possibility of NONOPEP in 20% (12/59) of calls to the information telephone services on AIDS. CONCLUSIONS: HIV risk accidents susceptible of NONOPEP are relatively frequent. Without forgetting the greater importance of primary prevention, it is advisable to reach and agreement on homogeneous recommendations. It is also advisable to draw up a surveillance system to evaluate the application and eventually the effectiveness of these recommendations.

Profilaxis postexposición al virus de la inmunodeficiencia humana no ocupacional.Conocimientos y prácticas de profesionales y grupos con conductas de riesgo / Non-occupational post-exposure HIV prophylaxis. Knowledge and practices among physicians and groups with risk behavior

FUNDAMENTO Y OBJETIVO: Mientras que la profilaxis postexposición ocupacional es ampliamente admitida y difundida, la profilaxis postexposición no ocupacional (NONOPEP) es controvertida. La prevención de la transmisión maternoinfantil del virus de la inmunodeficiencia humana (VIH), estudios experimentales animales y retrospectivos en trabajadores sanitarios, además de la plausibilidad biológica justificarían el uso en determinadas circunstancias de la NONOPEP. El objetivo de este trabajo ha sido revisar la existencia de recomendaciones oficiales sobre NONOPEP y describir las actitudes, conocimientos y prácticas sobre esta profilaxis de los médicos que atienden exposiciones accidentales no ocupacionales y personas con conductas de riesgo (varones homosexuales y usuarios de drogas por vía parenteral [UDVP]), así como describir la respuesta en teléfonos de atención al público sobre el sida, en España. SUJETOS Y MÉTODO: Estudio descriptivo mediante una encuesta en cada población definida en el apartado anterior entre septiembre de 1999 y julio de 2000, mediante cuestionarios autoadministrados y entrevistas personales. Para los teléfonos se realizaron consultas simuladas anónimas, previamente protocolizadas. RESULTADOS: No había hasta el momento recomendaciones oficiales. El 84 por ciento (97/116) de los médicos consultados había atendido algún caso de accidente no ocupacional con exposición de riesgo al VIH en los últimos 6 meses, el 77 por ciento (75/97) de éstos habían prescrito NONOPEP y el 76 por ciento (57/75) había usado las recomendaciones de los Centers for Disease Control (CDC) de 1998 para la exposición ocupacional. Los casos más frecuentemente atendidos fueron pinchazos con aguja en la calle y roturas de preservativo. Se evidenciaron discrepancias entre los médicos en la evaluación del riesgo y la prescripción en casos de riesgo intermedio. El 41 por ciento (103/252) de los homosexuales y el 2 por ciento (3/160) de los UDVP en tratamiento conocían la NONOPEP. El 15 por ciento (15/98) y el 59 por ciento (70/118), respectivamente, tomarían menos precauciones para evitar la infección por el VIH al disponer de la NONOPEP. En el 20 por ciento (12/59) de las consultas a los teléfonos de información sobre el sida se mencionó la posibilidad de la NONOPEP. CONCLUSIONES: Los accidentes de riesgo para contraer el VIH susceptibles de NONOPEP son relativamente frecuentes. Sin olvidar la mayor importancia de la prevención primaria, es conveniente disponer de unas recomendaciones de actuación homogéneas y consensuadas, y de un sistema de vigilancia epidemiológica para evaluar la aplicación y eventualmente la efectividad de estas recomendaciones. (AU)