The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial.

BACKGROUND: The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening. METHODS: A two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2-3 weeks after the intervention. DISCUSSION: This is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country. TRIAL REGISTRATION: ClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.

Hacia la concentración de la cirugía oncológica digestiva: cambios en la actividad, las técnicas y los resultados / Towards the centralization of digestive oncologic surgery: changes in activity, techniques and outcome

Objetivo: se examinaron los cambios en actividad, técnicas quirúrgicas y resultados del proceso de concentración de la cirugía oncológica digestiva compleja entre 2005-2012 en relación a 1996-2000. Material y métodos: se realizó un estudio de cohortes retrospectivo a partir del Conjunto Mínimo Básico de Datos (CMBD) al alta hospitalaria (1996-2012) de centros públicos de Catalunya. Población > 18 años intervenida de cáncer de: esófago, páncreas, hígado, estómago y recto. Los centros se clasificaron en: bajo, medio y alto volumen (≤ 5, 6-10 y > 10 procedimientos/año, respectivamente). Utilización del test tendencia Chi-cuadrado para valorar la concentración de pacientes en centros de alto volumen y la evolución de la mortalidad hospitalaria y regresión logística para estudiar la relación entre volumen y resultado en el periodo de concentración (2005-2012). Resultados: se ha producido una progresiva concentración de la cirugía oncológica digestiva compleja, mediante la reducción de entre un 10% (hígado) y 46% (esófago) del número de hospitales que realizan estas intervenciones y el aumento significativo del porcentaje de pacientes intervenidos en centros de alto volumen (todas las p tendencia < 0,0001, excepto esófago). También se observa una reducción significativa de la mortalidad, especialmente en esófago (de 15% en 1996/2000 a 7% en 2009/12, p tendencia = 0,003) y páncreas (de 12% en 1996/2000 a 6% en 2009/2012, p tendencia < 0,0001). Conclusiones: se ha producido una concentración efectiva de la cirugía oncológica digestiva en Cataluña en centros de alto volumen que se ha acompañado de una reducción de la mortalidad hospitalaria clara en esófago y páncreas, aunque sin cambios significativos en los otros cánceres estudiados (AU)

Aim: The objective of the present study was to examine changes in the activity, surgical techniques and results from the process of centralization of complex digestive oncologic surgery in 2005-2012 as compared to 1996-2000. Material and methods: A retrospective cohort study employing the minimum basic data set of hospital discharge (MBDSHD 1996-2012) from public centers in Catalonia (Spain) was performed. The population consisted of individuals aged > 18 who underwent digestive oncologic surgery (esophagus, pancreas, liver, stomach or rectum). Medical centers were divided into low, medium, and high-volume centers (≤ 5, 6-10, and > 10 interventions/year, respectively). The tendency Chi-squared test was used to assess the centralization of patients in high-volume centers and hospital mortality evolution during the study period. Logistic regression was performed to assess the relationship between volume and outcome. Results: A centralization of complex oncologic digestive surgery between 10% (liver) and 46% (esophagus) was obtained by means of a reduction in the number of hospitals that perform these interventions and a significant rise in the number of patients operated in high-volume centers (all types p ≤ 0.0001, except for esophagus). A significant decrease in mortality was observed, especially in esophagus (from 15% in 1996/2000 to 7% in 2009/12, p = 0.003) and pancreas (from 12% in 1996/2000 to 6% in 2009/12, p trend < 0.0001). Conclusions: A centralization of oncologic digestive surgery in high-volume centers and a reduction of hospital mortality in Catalonia were reported among esophageal and pancreatic cancers. However, no significant changes were found for others cancer types (AU)

Towards the centralization of digestive oncologic surgery: changes in activity, techniques and outcome.

AIM: The objective of the present study was to examine changes in the activity, surgical techniques and results from the process of centralization of complex digestive oncologic surgery in 2005-2012 as compared to 1996-2000. MATERIAL AND METHODS: A retrospective cohort study employing the minimum basic data set of hospital discharge (MBDSHD 1996-2012) from public centers in Catalonia (Spain) was performed. The population consisted of individuals aged > 18 who underwent digestive oncologic surgery (esophagus, pancreas, liver, stomach or rectum). Medical centers were divided into low, medium, and high-volume centers (≤ 5, 6-10, and > 10 interventions/year, respectively). The tendency Chi-squared test was used to assess the centralization of patients in high-volume centers and hospital mortality evolution during the study period. Logistic regression was performed to assess the relationship between volume and outcome. RESULTS: A centralization of complex oncologic digestive surgery between 10% (liver) and 46% (esophagus) was obtained by means of a reduction in the number of hospitals that perform these interventions and a significant rise in the number of patients operated in high-volume centers (all types p ≤ 0.0001, except for esophagus). A significant decrease in mortality was observed, especially in esophagus (from 15% in 1996/2000 to 7% in 2009/12, p = 0.003) and pancreas (from 12% in 1996/2000 to 6% in 2009/12, p trend < 0.0001). CONCLUSIONS: A centralization of oncologic digestive surgery in high-volume centers and a reduction of hospital mortality in Catalonia were reported among esophageal and pancreatic cancers. However, no significant changes were found for others cancer types.

Cost-effectiveness and harm-benefit analyses of risk-based screening strategies for breast cancer.

The one-size-fits-all paradigm in organized screening of breast cancer is shifting towards a personalized approach. The present study has two objectives: 1) To perform an economic evaluation and to assess the harm-benefit ratios of screening strategies that vary in their intensity and interval ages based on breast cancer risk; and 2) To estimate the gain in terms of cost and harm reductions using risk-based screening with respect to the usual practice. We used a probabilistic model and input data from Spanish population registries and screening programs, as well as from clinical studies, to estimate the benefit, harm, and costs over time of 2,624 screening strategies, uniform or risk-based. We defined four risk groups, low, moderate-low, moderate-high and high, based on breast density, family history of breast cancer and personal history of breast biopsy. The risk-based strategies were obtained combining the exam periodicity (annual, biennial, triennial and quinquennial), the starting ages (40, 45 and 50 years) and the ending ages (69 and 74 years) in the four risk groups. Incremental cost-effectiveness and harm-benefit ratios were used to select the optimal strategies. Compared to risk-based strategies, the uniform ones result in a much lower benefit for a specific cost. Reductions close to 10% in costs and higher than 20% in false-positive results and overdiagnosed cases were obtained for risk-based strategies. Optimal screening is characterized by quinquennial or triennial periodicities for the low or moderate risk-groups and annual periodicity for the high-risk group. Risk-based strategies can reduce harm and costs. It is necessary to develop accurate measures of individual risk and to work on how to implement risk-based screening strategies.

Cost-effectiveness of early detection of breast cancer in Catalonia (Spain).

BACKGROUND: Breast cancer (BC) causes more deaths than any other cancer among women in Catalonia. Early detection has contributed to the observed decline in BC mortality. However, there is debate on the optimal screening strategy. We performed an economic evaluation of 20 screening strategies taking into account the cost over time of screening and subsequent medical costs, including diagnostic confirmation, initial treatment, follow-up and advanced care. METHODS: We used a probabilistic model to estimate the effect and costs over time of each scenario. The effect was measured as years of life (YL), quality-adjusted life years (QALY), and lives extended (LE). Costs of screening and treatment were obtained from the Early Detection Program and hospital databases of the IMAS-Hospital del Mar in Barcelona. The incremental cost-effectiveness ratio (ICER) was used to compare the relative costs and outcomes of different scenarios. RESULTS: Strategies that start at ages 40 or 45 and end at 69 predominate when the effect is measured as YL or QALYs. Biennial strategies 50-69, 45-69 or annual 45-69, 40-69 and 40-74 were selected as cost-effective for both effect measures (YL or QALYs). The ICER increases considerably when moving from biennial to annual scenarios. Moving from no screening to biennial 50-69 years represented an ICER of 4,469€ per QALY. CONCLUSIONS: A reduced number of screening strategies have been selected for consideration by researchers, decision makers and policy planners. Mathematical models are useful to assess the impact and costs of BC screening in a specific geographical area.

Estado actual de la cirugía oncológica de mama en Andalucía y Cataluña / Current state of breast cancer surgery in Andalusia and Catalonia

Introducción La cirugía es un elemento esencial en el tratamiento del cáncer de mama. El objetivo del trabajo es describir la evolución y el estado actual de la cirugía oncológica de mama en Cataluña y Andalucía. Material y método Se llevó a cabo un estudio observacional basado en el análisis del Conjunto Mínimo Básico de Datos de Altas Hospitalarias en el período 1996–2005.ResultadosLa muestra incluyó a 37.537 mujeres de Cataluña y 24.186 de Andalucía. En el periodo estudiado se produjo un notable incremento de las tasas de hospitalización. Igualmente hay un marcado incremento en el porcentaje de casos intervenidos mediante cirugía conservadora. Sin embargo, esta difusión de la cirugía conservadora ha sido desigual por grupos de edad y tipo de centro. Conclusiones En conjunto se pone de relieve el aumento de la proporción de mujeres tratadas con mastectomía subtotal y la necesidad de estrategias que favorezcan la diseminación de intervenciones de probada efectividad (AU)

Background Surgery is an essential element of breast cancer treatment. The aim of this study was to describe the progress and current practice in oncological breast surgery in Catalonia and Andalusia. Material and method An observational study was conducted, collecting data from the Minimum Basic Data Set at Hospital Discharge. Results A total of 37,537 women from Catalonia and 24,186 from Andalusia were studied. The rate of admission due to breast cancer in women increased substantially during the study period, as well as the percentage of women who underwent breast-conserving surgery. However, the increase in breast-conserving surgery has not been consistent among age groups and hospital levels. Conclusions As a whole, the increase in breast-conserving surgery has shown the need for interventions to promote the use of procedures of proven effectiveness (AU)

[Current state of breast cancer surgery in Andalusia and Catalonia]. / Estado actual de la cirugía oncológica de mama en Andalucía y Cataluña.

BACKGROUND: Surgery is an essential element of breast cancer treatment. The aim of this study was to describe the progress and current practice in oncological breast surgery in Catalonia and Andalusia. MATERIAL AND METHOD: An observational study was conducted, collecting data from the Minimum Basic Data Set at Hospital Discharge. RESULTS: A total of 37,537 women from Catalonia and 24,186 from Andalusia were studied. The rate of admission due to breast cancer in women increased substantially during the study period, as well as the percentage of women who underwent breast-conserving surgery. However, the increase in breast-conserving surgery has not been consistent among age groups and hospital levels. CONCLUSIONS: As a whole, the increase in breast-conserving surgery has shown the need for interventions to promote the use of procedures of proven effectiveness.

Effectiveness of early detection on breast cancer mortality reduction in Catalonia (Spain).

BACKGROUND: At present, it is complicated to use screening trials to determine the optimal age intervals and periodicities of breast cancer early detection. Mathematical models are an alternative that has been widely used. The aim of this study was to estimate the effect of different breast cancer early detection strategies in Catalonia (Spain), in terms of breast cancer mortality reduction (MR) and years of life gained (YLG), using the stochastic models developed by Lee and Zelen (LZ). METHODS: We used the LZ model to estimate the cumulative probability of death for a cohort exposed to different screening strategies after T years of follow-up. We also obtained the cumulative probability of death for a cohort with no screening. These probabilities were used to estimate the possible breast cancer MR and YLG by age, period and cohort of birth. The inputs of the model were: incidence of, mortality from and survival after breast cancer, mortality from other causes, distribution of breast cancer stages at diagnosis and sensitivity of mammography. The outputs were relative breast cancer MR and YLG. RESULTS: Relative breast cancer MR varied from 20% for biennial exams in the 50 to 69 age interval to 30% for annual exams in the 40 to 74 age interval. When strategies differ in periodicity but not in the age interval of exams, biennial screening achieved almost 80% of the annual screening MR. In contrast to MR, the effect on YLG of extending screening from 69 to 74 years of age was smaller than the effect of extending the screening from 50 to 45 or 40 years. CONCLUSION: In this study we have obtained a measure of the effect of breast cancer screening in terms of mortality and years of life gained. The Lee and Zelen mathematical models have been very useful for assessing the impact of different modalities of early detection on MR and YLG in Catalonia (Spain).

Planificación de los servicios de alta especialización en Cataluña / Planning highly specialised services in Catalonia

Uno de los retos más importantes de los sistemas sanitarios es decidir qué prestaciones se han de concentrar, ateniéndonos a su baja frecuencia, complejidad, riesgo, experiencia acumulada y costes, entre otros factores. La concentración ha de permitir garantizar la calidad de la prestación y los mejores resultados posibles. En este artículo se describen los elementos conceptuales, los criterios de referencia, el impacto en los centros y las condiciones necesarias que han de reunir los dispositivos, y que se han tenido en cuenta en la reordenación de la alta complejidad en Cataluña. También se exponen algunos de los temas que se han tratado en el proceso de reordenación, como la cardiología terciaria, tanto en el apartado de la cirugía cardíaca como en el de la angioplastia coronaria terapéutica, y la oncología, en el apartado de las cirugías oncológicas poco frecuentes. También se abordan el trasplante renal, la atención al politraumatismo grave y el despliegue de la tomografía por emisión de positrones

One of the principal challenges in healthcare systems is deciding which services have to be concentrated, taking into account, among other things, their low-frequency, complexity, risk, accumulated experience and costs., Concentration must make it possible to guarantee the quality of the service and the best results possible. This article describes, the conceptual elements, the benchmark criteria, the impact on the centres and the minimum conditions that the mechanisms must meet, which have been taken into account in the reorganisationof high-complexity services in Catalonia. Some of those issues that have been dealt with in the restructuring process are also considered, such as tertiary cardiology, in both the cardiac surgery and therapeuticcoronary angioplasty sections, and oncology in the section of infrequent oncological surgery. Renal transplants, serious multiple-trauma care and the use of positron emission tomography are also dealt with

Competing risks to breast cancer mortality in Catalonia.

BACKGROUND: Breast cancer mortality has experienced important changes over the last century. Breast cancer occurs in the presence of other competing risks which can influence breast cancer incidence and mortality trends. The aim of the present work is: 1) to assess the impact of breast cancer deaths among mortality from all causes in Catalonia (Spain), by age and birth cohort and 2) to estimate the risk of death from other causes than breast cancer, one of the inputs needed to model breast cancer mortality reduction due to screening or therapeutic interventions. METHODS: The multi-decrement life table methodology was used. First, all-cause mortality probabilities were obtained by age and cohort. Then mortality probability for breast cancer was subtracted from the all-cause mortality probabilities to obtain cohort life tables for causes other than breast cancer. These life tables, on one hand, provide an estimate of the risk of dying from competing risks, and on the other hand, permit to assess the impact of breast cancer deaths on all-cause mortality using the ratio of the probability of death for causes other than breast cancer by the all-cause probability of death. RESULTS: There was an increasing impact of breast cancer on mortality in the first part of the 20th century, with a peak for cohorts born in 1945-54 in the 40-49 age groups (for which approximately 24% of mortality was due to breast cancer). Even though for cohorts born after 1955 there was only information for women under 50, it is also important to note that the impact of breast cancer on all-cause mortality decreased for those cohorts. CONCLUSION: We have quantified the effect of removing breast cancer mortality in different age groups and birth cohorts. Our results are consistent with US findings. We also have obtained an estimate of the risk of dying from competing-causes mortality, which will be used in the assessment of the effect of mammography screening on breast cancer mortality in Catalonia.

Dissemination of periodic mammography and patterns of use, by birth cohort, in Catalonia (Spain).

BACKGROUND: In Catalonia (Spain) breast cancer mortality has declined since the beginning of the 1990 s. The dissemination of early detection by mammography and the introduction of adjuvant treatments are among the possible causes of this decrease, and both were almost coincident in time. Thus, understanding how these procedures were incorporated into use in the general population and in women diagnosed with breast cancer is very important for assessing their contribution to the reduction in breast cancer mortality. In this work we have modeled the dissemination of periodic mammography and described repeat mammography behavior in Catalonia from 1975 to 2006. METHODS: Cross-sectional data from three Catalan Health Surveys for the calendar years 1994, 2002 and 2006 was used. The dissemination of mammography by birth cohort was modeled using a mixed effects model and repeat mammography behavior was described by age and survey year. RESULTS: For women born from 1938 to 1952, mammography clearly had a period effect, meaning that they started to have periodic mammograms at the same calendar years but at different ages. The age at which approximately 50% of the women were receiving periodic mammograms went from 57.8 years of age for women born in 1938-1942 to 37.3 years of age for women born in 1963-1967. Women in all age groups experienced an increase in periodic mammography use over time, although women in the 50-69 age group have experienced the highest increase. Currently, the target population of the Catalan Breast Cancer Screening Program, 50-69 years of age, is the group that self-reports the highest utilization of periodic mammograms, followed by the 40-49 age group. A higher proportion of women of all age groups have annual mammograms rather than biennial or irregular ones. CONCLUSION: Mammography in Catalonia became more widely implemented during the 1990 s. We estimated when cohorts initiated periodic mammograms and how frequently women are receiving them. These two pieces of information will be entered into a cost-effectiveness model of early detection in Catalonia.

[Planning highly specialised services in Catalonia]. / Planificación de los servicios de alta especialización en Cataluña.

One of the principal challenges in healthcare systems is deciding which services have to be concentrated, taking into account, among other things, their low-frequency, complexity, risk, accumulated experience and costs., Concentration must make it possible to guarantee the quality of the service and the best results possible. This article describes, the conceptual elements, the benchmark criteria, the impact on the centres and the minimum conditions that the mechanisms must meet, which have been taken into account in the reorganisation of high-complexity services in Catalonia. Some of those issues that have been dealt with in the restructuring process are also considered, such as tertiary cardiology, in both the cardiac surgery and therapeutic coronary angioplasty sections, and oncology in the section of infrequent oncological surgery. Renal transplants, serious multiple-trauma care and the use of positron emission tomography are also dealt with.

¿Influye en el proceso y en los resultados el volumen de procedimientos en la cirugía del cáncer? Análisis basado en datos clínico-administrativos / Does volume influence outcome in cancer surgery? Analysis based on clinical-administrative date

Introducción. La cirugía continúa siendo el tratamiento más efectivo en la mayoría de cánceres. Sin embargo, varios estudios han demostrado que existe una variabilidad en sus resultados y en los procedimientos quirúrgicos empleados. También se ha visto que hay una relación entre volumen de casos, resultados en mortalidad hospitalaria y tipos de técnica quirúrgica, así como en la supervivencia a largo plazo. El objetivo de este artículo es analizar la relación entre volumen de casos y mortalidad quirúrgica en los hospitales de Cataluña. Método. Hemos estudiado los datos proporcionados por el CMBDAH durante los años comprendidos entre 1996 y 2000 para algunos cánceres (páncreas, esófago, metástasis hepáticas, recto, pulmón, mama, estómago y próstata) y técnicas quirúrgicas (mastectomía, prostatectomía y colostomía). La asociación entre volumen y mortalidad intrahospitalaria por hospital se ha valorado utilizando un modelo de regresión logística. Las variables independientes eran la edad, el número de procedimientos (menos de 6, de 6 a 10 y más de 10 procedimientos por año) y el índice de Charlson. Resultados. Se ha observado una tendencia estadísticamente significativa hacia menos mortalidad en hospitales de alto volumen en el cáncer de páncreas y las metástasis hepáticas, y no en el cáncer de estómago. En el cáncer de esófago los mejores resultados se dan en hospitales de volumen intermedio. También se ha observado una proporción alta en cuanto a las mastectomías subtotales, las gastrectomías totales y las prostatectomías radicales en hospitales de alto volumen, y una tendencia inversa para las colostomías. Conclusiones. Los resultados en nuestro entorno confirman los datos aportados en la bibliografía de otros países sobre la existencia de dicha relación, aunque sólo en algunos tipos de cirugía del cáncer.Las limitaciones inherentes a este estudio retrospectivo basado en datos administrativos y con dificultades en el ajuste del riesgo sugieren la conveniencia de un nuevo estudio específico y prospectivo que permita un mejor ajuste de las características de los pacientes (AU)

Cáncer. Evaluación de los objetivos del Plan de Salud de Cataluña para el año 2000 / Cancer. Evaluation of the objectives of the Health Plan for Catalonia for the year 2000

Fundamento y objetivo: Evaluar el grado de consecución de los objetivos de salud en el ámbito del cáncer formulados para Cataluña en el año 2000. Población y método: A partir de la información recogida en el Registro de Mortalidad de Cataluña, el Registro de Cáncer de Tarragona, el Registro de Cáncer de Gerona y encuestas de salud de Cataluña se han evaluado los objetivos de salud para el año 2000 relacionados con el cáncer. Resultado:La mortalidad entre varones de entre 35 y 64 años en 1990, en comparación con 1998, descendió de una tasa ajustada según la edad de 232,3 a 219,1 con una disminución del 5,7%. En mujeres fue de 123,8 en el año 1990 y de 108,2 en 1998, con un descenso del 12,6%; en los años 1990-1998 se advierte un descenso significativo de tumores de mama y de cuello uterino en mujeres y de pulmón en los varones. Conclusión: La evaluación realizada permite afirmar que se han alcanzado los objetivos referidos a la mortalidad por debajo de 65 años en cáncer de mama y cuello uterino en las mujeres, y de cáncer de pulmón en los varones (AU)

Background and objective: To evaluate the degree of achievement of the health objectives related to cancer in the framework of the Catalonian Health Plan 2000. Subjects and method: We have used the information from the Registro de Mortalidad de Cataluña, Registro de Cáncer de Tarragona, Registro de Cáncer de Gerona and health surveys from Catalonia. Results: Men mortality ages 35-64 diminished significantly between 1990 and 1998. The age adjusted mortality rate change was 232.3 to 219.1 (5.7%). In women, it decreased from 123.8 in 1990 to 108.2 in 1998 (12.6%). This period exhibits a significant downward trend of breast and uterine cervical neoplasms in women and lung tumours in men. Conclusion: Our evaluation allows to strengthen that the objectives related to mortality under 65 in breast and uterine cervical cancer in women and lung cancer in men have been achieved (AU)