An Integrated Care Platform System (C3-Cloud) for Care Planning, Decision Support, and Empowerment of Patients With Multimorbidity: Protocol for a Technology Trial.

BACKGROUND: There is an increasing need to organize the care around the patient and not the disease, while considering the complex realities of multiple physical and psychosocial conditions, and polypharmacy. Integrated patient-centered care delivery platforms have been developed for both patients and clinicians. These platforms could provide a promising way to achieve a collaborative environment that improves the provision of integrated care for patients via enhanced information and communication technology solutions for semiautomated clinical decision support. OBJECTIVE: The Collaborative Care and Cure Cloud project (C3-Cloud) has developed 2 collaborative computer platforms for patients and members of the multidisciplinary team (MDT) and deployed these in 3 different European settings. The objective of this study is to pilot test the platforms and evaluate their impact on patients with 2 or more chronic conditions (diabetes mellitus type 2, heart failure, kidney failure, depression), their informal caregivers, health care professionals, and, to some extent, health care systems. METHODS: This paper describes the protocol for conducting an evaluation of user experience, acceptability, and usefulness of the platforms. For this, 2 "testing and evaluation" phases have been defined, involving multiple qualitative methods (focus groups and surveys) and advanced impact modeling (predictive modeling and cost-benefit analysis). Patients and health care professionals were identified and recruited from 3 partnering regions in Spain, Sweden, and the United Kingdom via electronic health record screening. RESULTS: The technology trial in this 4-year funded project (2016-2020) concluded in April 2020. The pilot technology trial for evaluation phases 3 and 4 was launched in November 2019 and carried out until April 2020. Data collection for these phases is completed with promising results on platform acceptance and socioeconomic impact. We believe that the phased, iterative approach taken is useful as it involves relevant stakeholders at crucial stages in the platform development and allows for a sound user acceptance assessment of the final product. CONCLUSIONS: Patients with multiple chronic conditions often experience shortcomings in the care they receive. It is hoped that personalized care plan platforms for patients and collaboration platforms for members of MDTs can help tackle the specific challenges of clinical guideline reconciliation for patients with multimorbidity and improve the management of polypharmacy. The initial evaluative phases have indicated promising results of platform usability. Results of phases 3 and 4 were methodologically useful, yet limited due to the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT03834207; https://clinicaltrials.gov/ct2/show/NCT03834207. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/21994.

Association Between Egg Consumption and Dementia Risk in the EPIC-Spain Dementia Cohort.

Background: Current evidence suggests that egg composition might have potential neuroprotective effects. Our aim was to determine the association between egg consumption and the risk of dementia in a Mediterranean population. Methods: This study was carried out in 3 centers from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Spain Dementia Cohort, i.e., 25,015 participants aged 30-70 years, recruited in 1992-1996, and followed up for a mean of 21.5 years. Results: A total of 774 incident dementia cases were diagnosed and validated, of which 518 were Alzheimer's disease (AD). Data on egg consumption were estimated using a validated dietary history questionnaire at recruitment. Cox proportional hazards models, adjusted for confounders, were used in the analyses. No association was observed between egg consumption and either total dementia [hazard ratio between extreme quartiles (HRQ4vs.Q1: 1.05; 95% CI 0.85-1.31; p-trend = 0.93)] or AD (HRQ4vs.Q1 0.93; 95% CI 0.72-1.21; p-trend = 0.50) risks. After dividing the population by adherence to the relative Mediterranean diet (rMED) score, a borderline inverse association was found between egg intake and both total dementia (HRQ4vs.Q1: 0.52; 95% CI 0.30-0.90; p-trend = 0.10) and AD (HRQ4vs.Q1: 0.52; 95% CI 0.27-1.01; p-trend = 0.13) risks within participants with low adherence to rMED score. However, no association was observed in participants with medium and high adherence to rMED score. Conclusion: This prospective study suggests that egg consumption is associated with a reduced risk of dementia, and specifically of AD, in the adult population with low adherence to rMED score; whereas it has no impact in subjects with moderate and high MD adherence.

Descriptive and predictive analysis identify centenarians' characteristics from the Basque population.

Background: Centenarians exhibit extreme longevity and have been postulated, by some researchers, as a model for healthy aging. The identification of the characteristics of centenarians might be useful to understand the process of human aging. Methods: In this retrospective study, we took advantage of demographic, clinical, biological, and functional data of deceased individuals between 2014 and 2020 in Guipúzcoa (Basque Country, Spain) taken from the Basque Health Service electronic health records data lake. Fifty characteristics derived from demographic, clinical, pharmaceutical, biological, and functional data were studied in the descriptive analysis and compared through differences in means tests. Twenty-seven of them were used to build machine learning models in the predictive analysis and their relevance for classifying centenarians was assessed. Results: Most centenarians were women and lived in nursing homes. Importantly, they developed fewer diseases, took fewer drugs, and required fewer medical attendances. They also showed better biological profiles, exhibiting lower levels of glucose, hemoglobin, glycosylated hemoglobin, and triglycerides in blood analysis compared with non-centenarians. In addition, machine learning analyses revealed the main characteristics of the profiles associated with centenarians' status as being women, having fewer consultations, having fewer diagnoses of neoplasms, and having lower levels of hemoglobin. Conclusions: Our results revealed the main characteristics linked to centenarians in the Basque Country using Computational Biology programs. These results expand the knowledge on the characterization of the centenarian population and hence of human longevity.

Mediterranean Diet and Risk of Dementia and Alzheimer's Disease in the EPIC-Spain Dementia Cohort Study.

The Mediterranean diet (MD) has shown to reduce the occurrence of several chronic diseases. To evaluate its potential protective role on dementia incidence we studied 16,160 healthy participants from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Spain Dementia Cohort study recruited between 1992-1996 and followed up for a mean (±SD) of 21.6 (±3.4) years. A total of 459 incident cases of dementia were ascertained through expert revision of medical records. Data on habitual diet was collected through a validated diet history method to assess adherence to the relative Mediterranean Diet (rMED) score. Hazard ratios (HR) of dementia by rMED levels (low, medium and high adherence levels: ≤6, 7-10 and ≥11 points, respectively) were estimated using multivariable Cox models, whereas time-dependent effects were evaluated using flexible parametric Royston-Parmar (RP) models. Results of the fully adjusted model showed that high versus low adherence to the categorical rMED score was associated with a 20% (HR = 0.80, 95%CI: 0.60-1.06) lower risk of dementia overall and HR of dementia was 8% (HR = 0.92, 0.85-0.99, p = 0.021) lower for each 2-point increment of the continuous rMED score. By sub-types, a favorable association was also found in women for non-AD (HR per 2-points = 0.74, 95%CI: 0.62-0.89), while not statistically significant in men for AD (HR per 2-points = 0.88, 0.76-1.01). The association was stronger in participants with lower education. In conclusion, in this large prospective cohort study MD was inversely associated with dementia incidence after accounting for major cardiovascular risk factors. The results differed by dementia sub-type, sex, and education but there was no significant evidence of effect modification.

Cost-effectiveness analysis of text messaging to support health advice for smoking cessation.

BACKGROUND: Smoking in one of the most serious public health problems. It is well known that it constitutes a major risk factor for chronic diseases and the leading cause of preventable death worldwide. Due to high prevalence of smokers, new cost-effective strategies seeking to increase smoking cessation rates are needed. METHODS: We performed a Markov model-based cost-effectiveness analysis comparing two treatments: health advice provided by general practitioners and nurses in primary care, and health advice reinforced by sending motivational text messages to smokers' mobile phones. A Markov model was used in which smokers transitioned between three mutually exclusive health states (smoker, former smoker and dead) after 6-month cycles. We calculated the cost-effectiveness ratio associated with the sending of motivational messages. Health care and society perspectives (separately) was adopted. Costs taken into account were direct health care costs and direct health care cost and costs for lost productivity, respectively. Additionally, deterministic sensitivity analysis was performed modifying the probability of smoking cessation with each option. RESULTS: Sending of text messages as a tool to support health advice was found to be cost-effective as it was associated with increases in costs of €7.4 and €1,327 per QALY gained (ICUR) for men and women respectively from a healthcare perspective, significantly far from the published cost-effectiveness threshold. From a societal perspective, the combined programmed was dominant. CONCLUSIONS: Sending text messages is a cost-effective approach. These findings support the implantation of the combined program across primary care health centres.

Impact of an organised population screening programme for colorectal cancer: Measurement after first and second rounds.

OBJECTIVE: The first and second rounds of the Basque programme for organised colorectal cancer screening were implemented between 2009 and 2014. Our objective was to measure the changes in incidence, tumour, node, metastasis staging distribution and tumour, node, metastasis-adjusted survival of patients with colorectal cancer from 2003 to 2014. METHOD: Colorectal cancer cases with screening (patients <70 years old) and without screening (patients ≥70 years old) were compared during three four-year periods: 2003-2006, 2007-2010 and 2011-2014 (fully implemented phase). Cox regression, five-year relative survival and cancer probability of death were calculated for each four-year period, age group and tumour, node, metastasis stage. Adjusted incidence rates were analysed by joinpoint regression. RESULTS: In an analysis of 23,301 cases of colorectal cancer, the incidence in patients younger than 70 years in 2013 showed a 17% annual decrease. The survival hazard ratios for stages I, II and III for 2003-2006 and 2007-2010 were compared to those for 2011-2014. From the first to the third period, diagnosis in the early stages (I and II) rose from 45.1% to 50.9% in the younger patient group and remained stable in the older group (49.6% and 49.4%). Additionally, the five-year relative survival rate increased significantly from 0.67 to 0.82 in those patients younger than 70 years, whereas in patients 70 years or older the rate did not change significantly (0.61 and 0.65). CONCLUSION: The screening reduced incidence and improved survival by anticipating the diagnosis and by reducing mortality for each tumour, node, metastasis stage in the target population. The effect on survival could also be due to lead-time bias.

Changes in lung cancer survival by TNM stage in the Basque country from 2003 to 2014 according to period of diagnosis.

INTRODUCTION: The objective of this study was to analyze the survival of patients with lung cancer by TNM stage in the 4-year periods 2003-2006, 2007-2010 and 2011-2014, treated in the Basque Health Service, and to compare this with survival in an equivalent sample of the general population. METHODS: A retrospective observational design was applied to cases from the Hospital Cancer Registry of Euskadi. A cohort of 11,635 patients had complete data for the following variables: TNM stage, age, sex, histology, date of diagnosis, vital status and date of death. Relative survival and Cox and parametric regression models were used to assess changes in survival. RESULTS: The lung cancer 5-year survival probability decreased with increasing stage, from 50-65% in patients with stage I disease to 2-3% in those with stage IV disease. Comparing patients diagnosed from 2011-2014 and 2003-2006, we found that survival improved: (a) the risk of death (hazard ratio) in 2003-2006 was 1.66 for stage I, 1.51 for stage II, 1.21 for stage III, and 1.10 for stage IV; (b) the 5-year relative survival increased from 11.0% to 17.8% in the period 2011-2014; and (c) the years of life lost decreased significantly from 2003-2006 to 2011-2014, varying between 6.16 (stage I) and 16.21 (stage IV). CONCLUSIONS: Survival from lung cancer by stage in the Basque Country has lengthened significantly across all disease stages. Nonetheless, since we estimated that lung cancer patients still have significantly lower mean survival times than the general population, there is a need for more research to improve these outcomes.

Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer.

BACKGROUND: It has been argued that laparoscopy should be a standard treatment in rectal cancer due to its greater technical complexity. The objective of this study was to conduct a cost-effectiveness analysis to compare laparoscopy with open surgery for rectal cancer adjusting for age and clinical stage. METHODS: A real-world prospective cost-effectiveness cohort study was conducted with data on costs and effectiveness at individual patient level. A "genetic matching" algorithm was used to correct for selection bias. After balancing the sample groups, combined multivariate analysis of total costs and quality-adjusted life years (QALYs) was performed using seemingly unrelated regression (SUR) models. These models were first constructed without interactions and, subsequently, effects of any age-stage interaction were analyzed. RESULTS: The sample included 601 patients (400 by laparoscopy and 201 by open surgery). Crude cost-effectiveness analysis indicated that overall laparoscopy was cheaper and associated with higher QALYs. The SUR models without interactions showed that while laparoscopy remained dominant, the incremental effectiveness decreased to the point that it offered no statistically significant benefits over open surgery. In the subgroup analysis, at advanced stages of the disease, although none of the coefficients were significant, the mean incremental effectiveness (QALYs value) for laparoscopy was positive in younger patients and negative in older patients. Further, for advanced stages, the mean cost of open surgery was lower in both age subgroups but differences did not reach statistical significance. In early stages, laparoscopy cost was significantly lower in the subgroup younger than 70 and higher in the older subgroup. CONCLUSIONS: The cost-effectiveness of laparoscopy in surgery for rectal cancer justifies this being the standard surgical procedure in young patients and those at initial stages. The choice of procedure should be discussed with patients who are older and/or in advanced stages of the disease. Trial registration ClinicalTrials.gov Identifier: NCT02488161.

Probabilistic cost-utility analysis and expected value of perfect information for the Oncotype multigenic test: a discrete event simulation model.

OBJECTIVE: To carry out a cost-utility analysis of the application of the Oncotype genomic test to inform the decision to use or not to use chemotherapy in the Basque Country (Spain). METHOD: The cost-utility study was carried out using a discrete event simulation model representing the natural history of breast cancer. The decision of treatment with chemotherapy based on Oncotype was compared with the standard of treatment based on clinical-pathological criteria. The model included clinical data from Basque hospitals and the literature and was processed by deterministic and probabilistic analysis to calculate the incremental cost-effectiveness ratio (ICER), the cost-effectiveness plane, the acceptability curve and the expected value of perfect information. The study adopted both a health and societal perspective. RESULTS: From a health perspective, the deterministic analysis estimated an ICER for Oncotype of 17,453 euros/quality-adjusted life year (QALY), discount included, and 9,613 euros/QALY without the discount. Eighty five percent (85%) of the simulations were below the efficiency threshold for Spain. The parametric variability associated with the Oncotype results was the main uncertainty factor in the decision. CONCLUSIONS: Oncotype is a cost-effective intervention from a health system perspective since each QALY gained costs less than 25,000 euros. From a societal perspective, it is dominant since it provides greater health and is accompanied by cost savings.

Survival and clinical events related to end-stage liver disease associated with HCV prior to the era of all oral direct-acting antiviral treatments.

Background: The aim of this study was to describe the natural long-term course of end-stage liver disease associated with chronic hepatitis C (HCV) infection by measuring survival and complication rates in the era prior to the arrival of new direct-acting antiviral (DAA) drugs. Methods: A retrospective population-based cohort study was designed to establish the follow-up of patients hospitalized for a decompensated cirrhotic event or hepatocellular carcinoma using electronic records from hospital discharge databases from 2009 to 2015. Their survival was compared with a sex, age and non-liver mortality excess matched simulation of the general Spanish population. Results: A total of 253 patients were included in the study. Among those with decompensated cirrhosis (n = 151) the hospital admission rate was 1.88 per patient-year with a mortality rate of 0.16 per patient-year. Mean survival was 4.10 years for patients with decompensated cirrhosis, and 1.75 for non-transplanted hepatocellular carcinoma, compared to 18.39 years for the general population. Conclusion: Our results show the complexity and rapid progression of end-stage liver disease associated with HCV infection. The considerable loss of life expectancy associated with the development of decompensated cirrhosis in patients with chronic HCV infection in the absence of viral clearance through treatment is acutely evident.

[The impact of patient identification on an integrated program of palliative care in Basque Country]. / Impacto de la identificación de pacientes en un programa de cuidados paliativos del País Vasco.

OBJECTIVE: Evaluate the process and the economic impact of an integrated palliative care program. DESIGN: Comparative cross-sectional study. LOCATION: Integrated Healthcare Organizations of Alto Deba and Goierri Alto-Urola, Basque Country. PARTICIPANTS: Patients dead due to oncologic and non-oncologic causes in 2012 (control group) and 2015 (intervention group) liable to need palliative care according to McNamara criteria. INTERVENTIONS: Identification as palliative patients in primary care, use of common clinical pathways in primary and secondary care and arrange training courses for health professionals. MAIN MEASURES: Change in the resource use profile of patients in their last 3 months. Propensity score by genetic matching method was used to avoid non-randomization bias. The groups were compared by univariate analysis and the relationships between variables were analysed by logistic regressions and generalized linear models. RESULTS: One thousand and twenty-three patients were identified in 2012 and 1,142 patients in 2015. In 2015 doubled the probability of being identify as palliative patient in deaths due to oncologic (19-33%) and non-oncologic causes (7-16%). Prescriptions of opiates rise (25-68%) and deaths in hospital remained stable. Contacts per patient with primary care and home hospitalization increased, while contacts with hospital admissions decreased. Cost per patient rise 26%. CONCLUSIONS: The integrated palliative care model increased the identification of the target population. Relationships between variables showed that the identification had a positive impact on prescription of opiates, death outside the hospital and extension to non-oncologic diseases. Although the identification decreased admissions in hospital, costs per patient had a slight increase due to home hospitalizations.

Cost-effectiveness analysis of laparoscopic versus open surgery in colon cancer.

BACKGROUND: Few economic evaluations have assessed laparoscopy for colon cancer. This study aimed to compare the cost-effectiveness of laparoscopic and open surgery for the treatment of colon cancer. METHOD: A cost-effectiveness analysis was performed comparing two groups of patients treated according to standard clinical practice (REDISSEC-CARESS/CCR cohort) by laparoscopic or open surgery. Data were collected from health records on clinical characteristics and resource use over 2 years after surgery. To calculate the incremental cost-effectiveness ratio, costs and quality-adjusted life years (QALYs) were obtained for each patient. Clinical heterogeneity was addressed using propensity score and joint multivariable analysis (seemingly unrelated regression) that included interactions between TNM stage, age, and surgical procedure to perform subgroup analysis. RESULTS: The sample was composed of 1591 patients, 963 who underwent laparoscopy and 628 open surgery. Using propensity score and regression analysis, we found that laparoscopy was associated with more QALYs and less resource use than open surgery (0.0163 QALYs, 95% CI 0.0114-0.0212; and - €3461, 95% CI - 3337 to - 3586). Costs were lower for laparoscopy in all subgroups. In the subgroups younger than 80 years old, utility was higher in patients who underwent laparoscopy. Nevertheless, open surgery had better outcomes in older patients in stages I-II (0.0618 QALYs) and IV (0.5090 QALYs). CONCLUSION: Overall, laparoscopy appears to be dominant, resulting in more QALYs and lower costs. Nevertheless, while laparoscopy required fewer resources in all subgroups, outcomes may be negatively affected in elderly patients, representing an opportunity for shared decision making between surgeons and patients. ClinicalTrials.gov Identifier: NCT02488161.

Cost-effectiveness and budget impact analyses of a colorectal cancer screening programme in a high adenoma prevalence scenario using MISCAN-Colon microsimulation model.

BACKGROUND: The Basque Colorectal Cancer Screening Programme began in 2009 and the implementation has been complete since 2013. Faecal immunological testing was used for screening in individuals between 50 and 69 years old. Colorectal Cancer in Basque country is characterized by unusual epidemiological features given that Colorectal Cancer incidence is similar to other European countries while adenoma prevalence is higher. The object of our study was to economically evaluate the programme via cost-effectiveness and budget impact analyses with microsimulation models. METHODS: We applied the Microsimulation Screening Analysis (MISCAN)-Colon model to predict trends in Colorectal Cancer incidence and mortality and to quantify the short- and long-term effects and costs of the Basque Colorectal Cancer Screening Programme. The model was calibrated to the Basque demographics in 2008 and age-specific Colorectal Cancer incidence data in the Basque Cancer Registry from 2005 to 2008 before the screening begun. The model was also calibrated to the high adenoma prevalence observed for the Basque population in a previously published study. The multi-cohort approach used in the model included all the cohorts in the programme during 30 years of implementation, with lifetime follow-up. Unit costs were obtained from the Basque Health Service and both cost-effectiveness analysis and budget impact analysis were carried out. RESULTS: The goodness-of-fit of the model adaptation to observed programme data was evidence of validation. In the cost-effectiveness analysis, the savings from treatment were larger than the added costs due to screening. Thus, the Basque programme was dominant compared to no screening, as life expectancy increased by 29.3 days per person. The savings in the budget analysis appeared 10 years after the complete implementation of the programme. The average annual budget was €73.4 million from year 2023 onwards. CONCLUSIONS: This economic evaluation showed a screening intervention with a major health gain that also produced net savings when a long follow-up was used to capture the late economic benefit. The number of colonoscopies required was high but remain within the capacity of the Basque Health Service. So far in Europe, no other population Colorectal Cancer screening programme has been evaluated by budget impact analysis.

Clinical and economic impact of the 21-gene recurrence score assay in adjuvant therapy decision making in patients with early-stage breast cancer: pooled analysis in 4 Basque Country university hospitals.

PURPOSE: The 21-gene recurrence score (RS) is a genomic test developed as a prognostic and predictive tool to improve the treatment decision making in cases of estrogen receptor-positive and human epidermal growth factor receptor 2-negative early-stage breast cancer. This study examined the clinical and economic impact of its use in 4 Basque Country university hospitals. METHODS: Taking into consideration the RS result, we recorded the recommended initial systemic adjuvant therapy (endocrine therapy with or without chemotherapy) according to standard clinicopathologic factors and the final decision about chemotherapy. Then, if the RS was high, chemotherapy was recommended; it was not recommended if the RS was low; for those with an intermediate RS, clinicopathologic factors were considered, and the initial recommendation based on those factors was maintained. In addition, the probability of switching treatment was calculated. Then, we developed an economic evaluation by measuring the treatment's incremental short-term budget impact from both the societal perspective and that of the Basque Health System. Patients' characteristics and chemotherapy use were analyzed using logistic regressions and receiver operating characteristic curves. RESULTS: Without an RS, chemotherapy would have been prescribed to 56% of 401 patients, but, with RS use, that percentage decreased to 25. The overall rate of decision change was 35.4%. Test inclusion led to a reduction in chemotherapy costs of €922 per patient in the total population. Although this reduction did not entirely offset the cost of the test, the productivity loss per patient was reduced by €1,977. CONCLUSION: The 21-gene RS test significantly changed the indication for chemotherapy. As chemotherapy treatments with no benefit were avoided, patients' quality of life was improved. The short-term economic impact was negative for the Basque Health Service, but savings resulted when sick-leave costs were included.

The cost of colorectal cancer according to the TNM stage. / Valoración del coste económico del cáncer colorrectal según estadio tumoral.

INTRODUCTION: The aim of this study was to measure the cost of treatment of colorectal cancer in the Basque public health system according to the clinical stage. METHODS: We retrospectively collected demographic data, clinical data and resource use of a sample of 529 patients. For stagesi toiii the initial and follow-up costs were measured. The calculation of cost for stageiv combined generalized linear models to relate the cost to the duration of follow-up based on parametric survival analysis. Unit costs were obtained from the analytical accounting system of the Basque Health Service. RESULTS: The sample included 110 patients with stagei, 171 with stageii, 158 with stageiii and 90 with stageiv colorectal cancer. The initial total cost per patient was 8,644€ for stagei, 12,675€ for stageii and 13,034€ for stageiii. The main component was hospitalization cost. Calculated by extrapolation for stageiv mean survival was 1.27years. Its average annual cost was 22,403€, and 24,509€ to death. The total annual cost for colorectal cancer extrapolated to the whole Spanish health system was 623.9million€. CONCLUSIONS: The economic burden of colorectal cancer is important and should be taken into account in decision-making. The combination of generalized linear models and survival analysis allows estimation of the cost of metastatic stage.

Economic evaluation of the breast cancer screening programme in the Basque Country: retrospective cost-effectiveness and budget impact analysis.

BACKGROUND: Breast cancer screening in the Basque Country has shown 20 % reduction of the number of BC deaths and an acceptable overdiagnosis level (4 % of screen detected BC). The aim of this study was to evaluate the breast cancer early detection programme in the Basque Country in terms of retrospective cost-effectiveness and budget impact from 1996 to 2011. METHODS: A discrete event simulation model was built to reproduce the natural history of breast cancer (BC). We estimated for lifetime follow-up the total cost of BC (screening, diagnosis and treatment), as well as quality-adjusted life years (QALY), for women invited to participate in the evaluated programme during the 15-year period in the actual screening scenario and in a hypothetical unscreened scenario. An incremental cost-effectiveness ratio was calculated with the use of aggregated costs. Besides, annual costs were considered for budget impact analysis. Both population level and single-cohort analysis were performed. A probabilistic sensitivity analysis was applied to assess the impact of parameters uncertainty. RESULTS: The actual screening programme involved a cost of 1,127 million euros and provided 6.7 million QALYs over the lifetime of the target population, resulting in a gain of 8,666 QALYs for an additional cost of 36.4 million euros, compared with the unscreened scenario. Thus, the incremental cost-effectiveness ratio was 4,214€/QALY. All the model runs in the probabilistic sensitivity analysis resulted in an incremental cost-effectiveness ratio lower than 10,000€/QALY. The screening programme involved an increase of the annual budget of the Basque Health Service by 5.2 million euros from year 2000 onwards. CONCLUSIONS: The BC screening programme in the Basque Country proved to be cost-effective during the evaluated period and determined an affordable budget impact. These results confirm the epidemiological benefits related to the centralised screening system and support the continuation of the programme.

Evaluation of health benefits and harms of the breast cancer screening programme in the Basque Country using discrete event simulation.

BACKGROUND: Since the breast cancer screening programme in the Basque Country (BCSPBC) was started in 1996, more than 400,000 women aged 50 to 69 years have been invited to participate. Based on epidemiological observations and simulation techniques it is possible to extend observed short term data into anticipated long term results. The aim of this study was to assess the effectiveness of the programme through 2011 by quantifying the outcomes in breast cancer mortality, life-years gained, false positive results, and overdiagnosis. METHODS: A discrete event simulation model was constructed to reproduce the natural history of breast cancer (disease-free, pre-clinical, symptomatic, and disease-specific death) and the actual observed characteristics of the screening programme during the evaluated period in the Basque women population. Goodness-of-fit statistics were applied for model validation. The screening effects were measured as differences in benefits and harms between the screened and unscreened populations. Breast cancer mortality reduction and life-years gained were considered as screening benefits, whereas, overdiagnosis and false positive results were assessed as harms. Results for a single cohort were also obtained. RESULTS: The screening programme yielded a 16 % reduction in breast cancer mortality and a 10 % increase in the incidence of breast cancer through 2011. Almost 2 % of all the women in the programme had a false positive result during the evaluation period. When a single cohort was analysed, the number of deaths decreased by 13 %, and 4 % of screen-detected cancers were overdiagnosed. Each woman with BC detected by the screening programme gained 2.5 life years due to early detection corrected by lead time. CONCLUSIONS: Fifteen years after the screening programme started, this study supports an important decrease in breast cancer mortality due to the screening programme, with reasonable risk of overdiagnosis and false positive results, and sustains the continuation of the breast cancer screening programme in the Basque population.

[Cost of breast cancer treatment by clinical stage in the Basque Country, Spain]. / Coste del tratamiento del cáncer de mama por estadío clínico en el País Vasco.

BACKGROUND: The burden of breast cancer is important for the healthcare system. In the context of the evaluation of the breast cancer screening program in the Basque Country it is important to determine the unitary costs related to diagnosis as well as the treatment costs depending on the clinical stage at detection. The main objective was to calculate the total cost and the components of breast cancer (BC) treatment depending on the clinical stage by 2011. METHODS: The estimated costs include BC diagnosis as so as to initial treatment and follow-up, based on resource consumption and unitary costs of the Basque Health Services. Micro-costing technique was applied based on the clinical guidelines. RESULTS: Our model showed the estimated loss of productivity due to premature The initial cost was 9.838€ for the stage 0, 17.273€ for stage I, 22.145€ for stage II and 28.776€ for stage III. The follow up annual cost was 172€ for the stage 0, 908€ for stage I, 994€ for stage II and 1.166€ for stage III. The annual cost for stage IV was 17879€. CONCLUSIONS: Chemotherapy determines the greatest percentage of BC costs. The two main drivers of the total cost of breast cancer are the initial treatment of stages I to III and the cost of stage IV, the latter reaching € 50,061 per patient.

Cost-utility analysis of gastric bypass for severely obese patients in Spain.

BACKGROUND: To assess the cost-utility of gastric bypass versus usual care for patients with severe obesity in Spain. METHODS: We have implemented a discrete-event simulation model with two branches: one branch involves gastric bypass, thereby reducing patients' BMI, and another branch where patients do not undergo surgery. The model analyzes the emergence of comorbidities (stroke, coronary obstructive disease, diabetes, and breast cancer) associated with obesity during a lifetime horizon. The selected measure of effectiveness is health-related quality of life. Both costs and effects are discounted at 3 %. A probabilistic sensitivity analysis is also performed using second-order Monte Carlo simulation; acceptability curves for different time horizons were also calculated. RESULTS: Patients with gastric bypass result in a lifetime increase of 5.63 quality-adjusted life years (QALYs) (18.18 vs. 12.55 QALYs). In addition, because of the reduced spending associated with the treatment of various obesity-related comorbidities, final savings stand at 13,994 . The total cost of the intervention branch is close to half the cost of the non-intervention branch (17,431 vs. 31,425 ). CONCLUSIONS: Gastric bypass is an intervention that dominates over the option of not intervening when a lifetime horizon is considered.

Budget impact analysis of switching to digital mammography in a population-based breast cancer screening program: a discrete event simulation model.

OBJECTIVE: To assess the budgetary impact of switching from screen-film mammography to full-field digital mammography in a population-based breast cancer screening program. METHODS: A discrete-event simulation model was built to reproduce the breast cancer screening process (biennial mammographic screening of women aged 50 to 69 years) combined with the natural history of breast cancer. The simulation started with 100,000 women and, during a 20-year simulation horizon, new women were dynamically entered according to the aging of the Spanish population. Data on screening were obtained from Spanish breast cancer screening programs. Data on the natural history of breast cancer were based on US data adapted to our population. A budget impact analysis comparing digital with screen-film screening mammography was performed in a sample of 2,000 simulation runs. A sensitivity analysis was performed for crucial screening-related parameters. Distinct scenarios for recall and detection rates were compared. RESULTS: Statistically significant savings were found for overall costs, treatment costs and the costs of additional tests in the long term. The overall cost saving was 1,115,857€ (95%CI from 932,147 to 1,299,567) in the 10th year and 2,866,124€ (95%CI from 2,492,610 to 3,239,638) in the 20th year, representing 4.5% and 8.1% of the overall cost associated with screen-film mammography. The sensitivity analysis showed net savings in the long term. CONCLUSIONS: Switching to digital mammography in a population-based breast cancer screening program saves long-term budget expense, in addition to providing technical advantages. Our results were consistent across distinct scenarios representing the different results obtained in European breast cancer screening programs.