Disentangling the value equation: a step forward in value-based healthcare.

BACKGROUND: The value equation of value-based healthcare (VBHC) as a single figure remains ambiguous, closer to a theoretical framework than a useful tool for decision making. The challenge lies in the way patient-centred outcomes (PCOs) might be combined to produce a single value of the numerator. This paper aims to estimate the weights of PCOs to provide a single figure in the numerator, which ultimately will allow a VBHC figure to be reached. METHODS: A cohort of patients diagnosed with breast cancer (n = 690) with a 6-month follow-up recruited in 2019-20 across six European hospitals was used. Patient-reported outcomes (PROs), clinical-related outcomes (CROs), and clinical and socio-demographic variables were collected. The numerator was defined as a composite indicator of the PCOs (CI-PCO), and regression analysis was applied to estimate their weights and consequently arrive at a single figure. RESULTS: Pain showed as the highest weight followed by physical functioning, emotional functioning, and ability to work, and then by a symptom, either arm or breast. PCOs weights were robust to sensitivity analysis. The CI-PCO value was found to be more informative than the health-related quality of life (HRQoL) value. CONCLUSIONS: To the best of our knowledge, this is the first research to combine the PCOs proposed by ICHOM to provide a single figure in the numerator of the value equation. This figure shows a step forward in VBHC to reach a holistic benchmarking across healthcare centres and a value-based payment. This research might also be applied in other medical conditions as a methodological pathway.

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.

Inequalities in health-related quality of life according to age, gender, educational level, social class, body mass index and chronic diseases using the Spanish value set for Euroquol 5D-5L questionnaire.

BACKGROUND: Reducing health inequalities on the basis of social factors has been a key driver in the development of Public Health policies. Health-related quality of life is a global indicator useful to assess health inequalities within a society. The objective of this study was to identify inequalities on health by analysing the interactive effects of gender, age, educational level, social class, body mass index and chronic diseases on health-related quality of life in a Spanish population sample. METHODS: We used data from the Spanish National Health Survey 2011-2012. Health-related quality of life was measured by the EQ-5D-5L instrument applying the Spanish value set. Probability of being in perfect health was ascertained by logistic regression models including gender, age, educational level, body mass index and social class and the corresponding terms of interaction. A two-part model combining logistic regression analysis and generalized linear models was applied to calculate the adjusted utility loss associated with chronic conditions (disutility values). RESULTS: The sample used for analysis contained 18,450 individuals. The mean age was 50 years, 51.3% were women, 55% were overweight or obese and 46.7% had low social status. The mean utility was 0.94 in men and 0.89 in women. Elderly women, obese people, those of low social class and those with chronic conditions had significant lower utility values. Within the regression analysis, interaction assessment revealed that the detrimental effect of obesity disappeared in higher social classes. Utility values for all chronic conditions considered were lower in women than in men and were on a gradient within social class, the lowest for individuals declaring stroke. The greatest decrease on health-related quality of life was determined by declaration of stroke (17.6%) or mental diseases (18.6%). CONCLUSIONS: The interactive effects of gender, age, educational level, social class, body mass index and chronic diseases on health-related quality of life in the Spanish population revealed important inequalities in health. Social class acted as a modulator of the stigma associated with obesity. Chronic conditions producing loss of autonomy had the greatest impact on reduction of health-related quality of life. This is the first study using the Spanish EQ-5D-5L value set to estimate utilities.

Gender and socioeconomic inequalities in the implementation of the Basque programme for multimorbid patients.

BACKGROUND: The aim of our study was to increase awareness of the relevance of the implemented programmes to inequity of access and inequality of health by analyzing the impact of a patient-centred strategy for multimorbid patients. METHODS: This retrospective study compared the 2014 multimorbid patient group (intervention group) with its 2012 analogue (control group), before the Department of Health of the Basque Country launched the strategy for managing disease chronicity. Inequalities in healthcare access were represented by differences in the inclusion of patients in the programme and in contacts with primary care (PC) services by gender and socioeconomic status (measured by deprivation index by census track). Likewise, differences in hospital care represented inequalities in health outcomes. Generalized linear models were used to analyze relationships among variables. A propensity score by a genetic matching approach was used to minimize possible selection bias. RESULTS: At baseline, women had less probability of being eligible for the programme. No clear patterns were seen in resource consumption in PC. The probability of hospitalization was higher for men and increased according to socioeconomic status. The implementation of the programme yielded more contacts with PC services in all groups and a reduction in hospitalizations, especially among men and the most socioeconomically deprived patients. CONCLUSION: The patient-centred, integrated-care intervention launched by the Department of Health of the Basque Country might have reduced some gender and socioeconomic inequalities in health outcomes, as it avoided more hospitalizations in subgroups that presented with more episodes of decompensation in the reference year.

[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 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.

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.

Economic evaluation of a population strategy for the treatment of chronic hepatitis C with direct-acting antivirals.

The high initial cost of antivirals against hepatitis C prompted development of the "Strategic Plan for Tackling Chronic Hepatitis C in the Spanish National Health System". The objective of this study was the economic evaluation of the first two years of its application in Navarre, Spain. The change in the natural history of hepatitis C produced by the sustained virological response (SVR) was compared to an alternative without treatment and modeled with patient-level data. By means of a discrete events simulation model, the cost-effectiveness and the budget impact analysis of the treatment program were measured from the perspective of the Navarre Health Service. Of 656 patients treated, 98% had SVR. The average cost of the treatments was 18,743 euros per patient. The incremental cost-effectiveness ratio (ICER) with discount was 5,346 euros per quality-adjusted life years, which became more efficient as the stage of fibrosis increased until it reached levels of dominance in stage 4 fibrosis. The associated costs for chronic liver disease decreased as the benefit of the treatment was expressed. The implementation of the Strategic Plan is cost-effective, with an ICER well below the threshold, since the cost of treatment is largely compensated by savings in long-term health expenditure. The budgetary impact foresees a net saving from the third year on. The two key parameters were the decrease in the price of the treatment and the SVR in nearly 100% of the patients.

Incorporating Budget Impact Analysis in the Implementation of Complex Interventions: A Case of an Integrated Intervention for Multimorbid Patients within the CareWell Study.

OBJECTIVES: To develop a framework for the management of complex health care interventions within the Deming continuous improvement cycle and to test the framework in the case of an integrated intervention for multimorbid patients in the Basque Country within the CareWell project. METHODS: Statistical analysis alone, although necessary, may not always represent the practical significance of the intervention. Thus, to ascertain the true economic impact of the intervention, the statistical results can be integrated into the budget impact analysis. The intervention of the case study consisted of a comprehensive approach that integrated new provider roles and new technological infrastructure for multimorbid patients, with the aim of reducing patient decompensations by 10% over 5 years. The study period was 2012 to 2020. RESULTS: Given the aging of the general population, the conventional scenario predicts an increase of 21% in the health care budget for care of multimorbid patients during the study period. With a successful intervention, this figure should drop to 18%. The statistical analysis, however, showed no significant differences in costs either in primary care or in hospital care between 2012 and 2014. The real costs in 2014 were by far closer to those in the conventional scenario than to the reductions expected in the objective scenario. The present implementation should be reappraised, because the present expenditure did not move closer to the objective budget. CONCLUSIONS: This work demonstrates the capacity of budget impact analysis to enhance the implementation of complex interventions. Its integration in the context of the continuous improvement cycle is transferable to other contexts in which implementation depth and time are important.

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.

[Prevalence of altered mismatch repair protein nuclear expression detected by immunohistochemistry on adenomas with high-grade dysplasia and features associated with this risk in a population-based study]. / Prevalencia de alteración de expresión nuclear de proteínas reparadoras con inmunohistoquímica sobre adenomas con displasia de alto grado y características asociadas a dicho riesgo en un estudio de base poblacional.

INTRODUCTION: Alteration of mismatch repair system protein expression detected by immunohistochemistry (IHQ) in tumoural tissue is a useful technique for Lynch Syndrome (LS) screening. A recent review proposes LS screening through immunohistochemical study not only in all diagnosed cases of colorectal cancer (CRC) but also in advanced adenomas, especially in young patients. OBJECTIVE: To assess the prevalence of altered IHQ carried out in all adenomas with high-grade dysplasia (HGD) diagnosed in our community in 2011, as well as the variables associated with this alteration. METHODS: We included all the cases of adenomatous polyps with HGD diagnosed in the three public pathology laboratories of Navarre during 2011 and performed a statistical study to assess the association between different patient and lesion characteristics and altered IHQ results. RESULTS: A total of 213 colonic adenomas with HGD were diagnosed, and 26 (12.2%) cases were excluded from the final analysis (2 known LS, 22 without IHQ study and 2 with inconclusive IHQ studies). The final number of adenomas included was 187. Pathologic results were found in 10 cases (5.35%)-6 cases in MLH1 and PMS2, 2 cases in PMS2, 1 case in MSH6 and 1 case in MSH2 and MSH6. The factors showing a statistically significant association with the presence of abnormal proteins were the synchronous presence of CRC, the presence of only one advanced adenoma, proximal location of HGD and age <50 years. CONCLUSIONS: The percentage of pathologic nuclear expression found in IHQ is high. Consequently, screening of all diagnosed HGD could be indicated, especially in young patients, with a single AA and proximal HGD.

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.

Using Age-Specific Rates for Parametric Survival Function Estimation in Simulation Models.

PURPOSE: To describe a procedure for incorporating parametric functions into individual-level simulation models to sample time to event when age-specific rates are available but not the individual data. METHODS: Using age-specific event rates, regression analysis was used to parametrize parametric survival distributions (Weibull, Gompertz, log-normal, and log-logistic), select the best fit using the R2 statistic, and apply the corresponding formula to assign random times to events in simulation models. We used stroke rates in the Spanish population to illustrate our procedure. RESULTS: The 3 selected survival functions (Gompertz, Weibull, and log-normal) had a good fit to the data up to 85 y of age. We selected Gompertz distribution as the best-fitting distribution due to its goodness of fit. CONCLUSIONS: Our work provides a simple procedure for incorporating parametric risk functions into simulation models without individual-level data. HIGHLIGHTS: We describe the procedure for sampling times to event for individual-level simulation models as a function of age from parametric survival functions when age-specific rates are available but not the individual dataWe used linear regression to estimate age-specific hazard functions, obtaining estimates of parameter uncertainty.Our approach allows incorporating parameter (second-order) uncertainty in individual-level simulation models needed for probabilistic sensitivity analysis in the absence of individual-level survival data.

GOIZ ZAINDU study: a FINGER-like multidomain lifestyle intervention feasibility randomized trial to prevent dementia in Southern Europe.

BACKGROUND: GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate the feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and data collection to design a large efficacy trial. METHOD: GOIZ ZAINDU is a 1-year, randomized, controlled trial of a multidomain intervention in persons aged 60+ years, with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥ 6, no diagnosis of dementia, and below-than-expected performance in at least one of three cognitive screening tests. Randomization to a multidomain intervention (MD-Int) or regular health advice (RHA) was stratified by sex, age (>/≤ 75), and cognitive status (mild cognitive impairment (MCI)/normal cognition). MD-Int included cardiovascular risk factor control, nutritional counseling, physical activity, and cognitive training. The primary outcomes were retention rate and adherence to the intervention program. Exploratory cognitive outcomes included changes in the Neuropsychological Test Battery z-scores. Analyses were performed according to the intention to treat. RESULTS: One hundred twenty-five participants were recruited (mean age: 75.64 (± 6.46); 58% women). The MD-Int (n = 61) and RHA (n = 64) groups were balanced in terms of their demographics and cognition. Fifty-two (85%) participants from the RHA group and 56 (88%) from the MD-Int group completed the study. More than 70% of the participants had high overall adherence to the intervention activities. The risk of cognitive decline was higher in the RHA group than in the MD-Int group in terms of executive function (p =.019) and processing speed scores (p =.026). CONCLUSIONS: The GOIZ-ZAINDU study proved that the FINGER methodology is adaptable and feasible in a different socio-cultural environment. The exploratory efficacy results showed a lower risk of decline in executive function and processing speed in the intervention group. These results support the design of a large-scale efficacy trial. TRIAL REGISTRATION: GOIZ ZAINDU feasibility trial was approved and registered by the Euskadi Drug Research Ethics Committee (ID: PI2017134) on 23 January 2018. Retrospectively registered in ClinicalTrials.gov (NCT06163716) on 8 December 2023.

An assessment of existing models for individualized breast cancer risk estimation in a screening program in Spain.

BACKGROUND: The aim of this study was to evaluate the calibration and discriminatory power of three predictive models of breast cancer risk. METHODS: We included 13,760 women who were first-time participants in the Sabadell-Cerdanyola Breast Cancer Screening Program, in Catalonia, Spain. Projections of risk were obtained at three and five years for invasive cancer using the Gail, Chen and Barlow models. Incidence and mortality data were obtained from the Catalan registries. The calibration and discrimination of the models were assessed using the Hosmer-Lemeshow C statistic, the area under the receiver operating characteristic curve (AUC) and the Harrell's C statistic. RESULTS: The Gail and Chen models showed good calibration while the Barlow model overestimated the number of cases: the ratio between estimated and observed values at 5 years ranged from 0.86 to 1.55 for the first two models and from 1.82 to 3.44 for the Barlow model. The 5-year projection for the Chen and Barlow models had the highest discrimination, with an AUC around 0.58. The Harrell's C statistic showed very similar values in the 5-year projection for each of the models. Although they passed the calibration test, the Gail and Chen models overestimated the number of cases in some breast density categories. CONCLUSIONS: These models cannot be used as a measure of individual risk in early detection programs to customize screening strategies. The inclusion of longitudinal measures of breast density or other risk factors in joint models of survival and longitudinal data may be a step towards personalized early detection of BC.

Two-year changes in generic and obesity-specific quality of life after gastric bypass.

The study objectives were to assess 2-year changes in health-related quality of life (HRQL) after gastric bypass in patients with severe obesity and to analyze HRQL improvements in relation to weight loss after bariatric surgery. This was a prospective intervention study with consecutive patients referred to two bariatric surgical units in the Basque Country. We used both generic (Short Form Health Survey, SF-36 and EuroQol, EQ-5D), and specific questionnaires (Moorehead-Ardelt, MA II and Obesity-related Problems Scale, OP). Effect sizes and receiver operating characteristic (ROC) curves were calculated to assess the change in quality of life. Spearman's correlation coefficient was calculated to assess whether there was an association between changes in body mass index (BMI) and HRQL. Of 82 patients who underwent surgery, 79 were followed-up for 2 years. Mean weight loss was 37% of body weight (49 kg) and BMI fell from 50.6 to 31.8. The initial problems and final improvements were greater in the physical dimensions. Considerable benefits were observed in assessments with all the instruments used. However, the changes in weight/BMI and HRQL were not linear. The comparison with general population showed a similar profile in SF-36 dimensions after surgery. Severely obese patients have lower perceived health across all dimensions of quality of life. Moreover, the impact on functioning is so important that severe obesity can be described as a cause of disability that disappears 2 years after surgical treatment. ROC curves indicate that most of the HRQL measures are poor predictors of change in terms of reduction in body weight or BMI.

Development and Validation of a Discrete Event Simulation Model to Evaluate the Cardiovascular Impact of Population Policies for Obesity.

INTRODUCTION: Our aim was to describe the development and validation of an obesity model representing the cardiovascular risks associated with different body mass index (BMI) categories, through simulation, designed to evaluate the epidemiological and economic impact of population policies for obesity. METHODS: A discrete event simulation model was built in R considering the risk of cardiovascular events (heart failure, stroke, coronary heart disease, and diabetes) associated with BMI categories in the Spanish population. The main parameters included in the model were estimated from Spanish hospital discharge records and the Spanish Health Survey and allowed both first-order and second-order (probabilistic sensitivity analysis) uncertainty to be programmed into the model. The simulation yielded the incidence and prevalence of cardiovascular events as validation outputs. To illustrate the capacity of the model, we estimated the reduction in cardiovascular events and cost-utility (incremental cost/incremental quality-adjusted life-years [QALYs]) of a hypothetical intervention that fully eliminated the cardiovascular risks associated with obesity and overweight. RESULTS: The Validation Status of Health-Economic decision models (AdViSHE) tool was applied. Internal validation plots showed adequate goodness of fit for the Spanish population. External validation was achieved by comparing the simulated and real incidence by age group for stroke, acute myocardial infarction, and heart failure. The intervention reduced the population hazard ratios of stroke, acute myocardial infarction, and heart failure to 0.81, 0.74, and 0.78, respectively, and added 0.74 QALYs to the whole population. CONCLUSIONS: This obesity simulation model evidenced good properties for estimating the long-term epidemiological and economic impact of policies to tackle obesity in Spain. The conceptual model could be implemented for other counties using country-specific input data.

Estimation of the epidemiology of dementia and associated neuropsychiatric symptoms by applying machine learning to real-world data.

INTRODUCTION: Incidence rates of dementia-related neuropsychiatric symptoms (NPS) are not known and this hampers the assessment of their population burden. The objective of this study was to obtain an approximate estimate of the population incidence and prevalence of both dementia and NPS. METHODS: Given the dynamic nature of the population with dementia, a retrospective study was conducted within the database of the Basque Health Service (real-world data) at the beginning and end of 2019. Validated random forest models were used to identify separately depressive and psychotic clusters according to their presence in the electronic health records of all patients diagnosed with dementia. RESULTS: Among the 631,949 individuals over 60 years registered, 28,563 were diagnosed with dementia, of whom 15,828 (55.4%) showed psychotic symptoms and 19,461 (68.1%) depressive symptoms. The incidence of dementia in 2019 was 6.8/1000 person-years. Most incident cases of depressive (72.3%) and psychotic (51.9%) NPS occurred in cases of incident dementia. The risk of depressive-type NPS grows with years since dementia diagnosis, living in a nursing home, and female sex, but falls with older age. In the psychotic cluster model, the effects of male sex, and older age are inverted, both increasing the probability of this type of symptoms. CONCLUSIONS: The stigmatization factor conditions the social and attitudinal environment, delaying the diagnosis of dementia, preventing patients from receiving adequate care and exacerbating families' suffering. This study evidences the synergy between big data and real-world data for psychiatric epidemiological research.

The impact of acquired brain damage in terms of epidemiology, economics and loss in quality of life.

BACKGROUND: Patients with acquired brain damage (ABD) have suffered a brain lesion that interrupts vital development in the physical, psychological and social spheres. Stroke and traumatic brain injury (TBI) are the two main causes. The objectives of this study were to estimate the incidence and prevalence of ABD in the population of the Basque Country and Navarre in 2008, to calculate the associated cost of the care required and finally to assess the loss in health-related quality of life. METHODS: On the one hand, a cross-sectional survey was carried out, in order to estimate the incidence of ABD and its consequences in terms of costs and loss in quality of life from the evolution of a sample of patients diagnosed with stroke and TBI. On the other hand, a discrete event simulation model was built that enabled the prevalence of ABD to be estimated. Finally, a calculation was made of the formal and informal costs of ABD in the population of the Basque Country and Navarre (2,750,000 people). RESULTS: The cross-sectional study showed that the incidences of ABD caused by stroke and TBI were 61.8 and 12.5 cases per 100,000 per year respectively, while the overall prevalence was 657 cases per 100,000 people. The SF-36 physical and mental component scores were 28.9 and 44.5 respectively. The total economic burden was calculated to be 382.14 million euro per year, distributed between 215.27 and 166.87 of formal and informal burden respectively. The average cost per individual was 21,040 € per year. CONCLUSIONS: The main conclusion of this study is that ABD has a high impact in both epidemiological and economic terms as well as loss in quality of life. The overall prevalence obtained is equivalent to 0.7% of the total population. The substantial economic burden is distributed nearly evenly between formal and informal costs. Specifically, it was found that the physical dimensions of quality of life are the most severely affected. The prevalence-based approach showed adequate to estimate the population impact of ABD and the resources needed to compensate the disability.