Publications by authors named "Xavier Castells"

178 Publications

Clinical practice guideline on pharmacological and psychological management of adult patients with depression and a comorbid substance use disorder.

Adicciones 2021 Mar 12;0(0):1559. Epub 2021 Mar 12.

IMIM-Institut Hospital del Mar d'Investigacions Mèdiques.

Co-occurrence of depression and a substance use disorder (SUD) in patients who present dual diagnoses has been long recognized as an important consideration in clinical practice. This review synthesizes the evidence of pharmacological and psychosocial interventions for comorbid depressive disorders and SUDs while providing clinical recommendations about the best interventions to address these patients. The best evidence from randomized controlled trials was used to evaluate treatment options. The strength of recommendations was described using the GRADE approach. Our results suggest that 1) In patients with depression and alcohol consumption, the administration of non-selective serotonin reuptake inhibitor (SSRI) antidepressants instead of SSRI is recommended for improvement of depressive symptoms (strong recommendation). Neither SSRI (strong recommendation) nor non-SSRI (weak recommendation) antidepressants are recommended for reduction in alcohol consumption. 2) In patients with depression and cannabis use, the use of venlafaxine is not recommended (weak recommendation). 3) In patients with depression and cocaine consumption, the use of SSRI antidepressants for improving depressive symptoms (weak recommendation) or to reduce cocaine use is not recommended (strong recommendation). The use of non-SSRI antidepressants is only recommended for improving depressive symptoms (strong recommendation). 4) The administration of bupropion to reduce nicotine consumption is not recommended (strong recommendation). 5) Regarding psychological treatment, in patients with depression and co-occurring alcohol disorder, both pharmacotherapy and cognitive behavioural therapy have positive effects on internalizing symptoms and in reducing alcohol consumption (weak recommendation). Our review suggests the need for more research in this area and for larger, multisite, randomized studies to provide more definite evidence.
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http://dx.doi.org/10.20882/adicciones.1559DOI Listing
March 2021

Use of health services among long-term breast cancer survivors in Spain: longitudinal study based on real-world data.

J Cancer Surviv 2021 Mar 23. Epub 2021 Mar 23.

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Passeig Marítim, 25-29, 08003, Barcelona, Spain.

Purpose: This study aimed to evaluate health service utilization in Spain among long-term breast cancer survivors and to compare it with that among women with no history of breast cancer.

Methods: Study based on the SURBCAN cohort includes a sample of long-term breast cancer survivors and a sample of women without breast cancer from 5 Spanish regions. Healthcare utilization was assessed through primary care, hospital visits, and tests during the follow-up period (2012 to 2016) by using electronic health records. Annual contact rates to healthcare services were calculated, and crude and multivariate count models were fitted to estimate the adjusted relative risk of healthcare services use.

Results: Data were obtained from 19,328 women, including 6512 long-term breast cancer survivors. Healthcare use was higher among breast cancer survivors (20.9 vs 16.6; p < 0.0001) and decreased from >10 years of survival. Breast cancer survivors who underwent a mastectomy were more likely to have a primary care visit (RR = 3.10 95% CI 3.08-3.11). Five to ten years survivors were more likely to have hospital inpatient visits and imaging test compared to women without breast cancer (RRa = 1.35 95% CI 1.30-1.39 and RRa = 1.27 95% CI 1.25-1.29 respectively).

Conclusion: This study shows higher use of health services in long-term breast cancer survivors than in women without breast cancer regardless of survival time.

Implications For Cancer Survivors: These results help to estimate the health resources needed for the growing group of breast cancer survivors and to identify risk factors that drive higher use of health services.
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http://dx.doi.org/10.1007/s11764-021-01011-zDOI Listing
March 2021

Developing and validating an individualized breast cancer risk prediction model for women attending breast cancer screening.

PLoS One 2021 23;16(3):e0248930. Epub 2021 Mar 23.

IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

Background: Several studies have proposed personalized strategies based on women's individual breast cancer risk to improve the effectiveness of breast cancer screening. We designed and internally validated an individualized risk prediction model for women eligible for mammography screening.

Methods: Retrospective cohort study of 121,969 women aged 50 to 69 years, screened at the long-standing population-based screening program in Spain between 1995 and 2015 and followed up until 2017. We used partly conditional Cox proportional hazards regression to estimate the adjusted hazard ratios (aHR) and individual risks for age, family history of breast cancer, previous benign breast disease, and previous mammographic features. We internally validated our model with the expected-to-observed ratio and the area under the receiver operating characteristic curve.

Results: During a mean follow-up of 7.5 years, 2,058 women were diagnosed with breast cancer. All three risk factors were strongly associated with breast cancer risk, with the highest risk being found among women with family history of breast cancer (aHR: 1.67), a proliferative benign breast disease (aHR: 3.02) and previous calcifications (aHR: 2.52). The model was well calibrated overall (expected-to-observed ratio ranging from 0.99 at 2 years to 1.02 at 20 years) but slightly overestimated the risk in women with proliferative benign breast disease. The area under the receiver operating characteristic curve ranged from 58.7% to 64.7%, depending of the time horizon selected.

Conclusions: We developed a risk prediction model to estimate the short- and long-term risk of breast cancer in women eligible for mammography screening using information routinely reported at screening participation. The model could help to guiding individualized screening strategies aimed at improving the risk-benefit balance of mammography screening programs.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248930PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7987139PMC
March 2021

Digital breast tomosynthesis compared to diagnostic mammographic projections (including magnification) among women recalled at screening mammography: a systematic review for the European Commission Initiative on Breast Cancer (ECIBC).

Cancer Med 2021 Apr 5;10(7):2191-2204. Epub 2021 Mar 5.

CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.

Background: Diagnostic mammography projections (DxMM) have been traditionally used in the assessment of women recalled after a suspicious screening mammogram. Digital breast tomosynthesis (DBT) reduces the tissue overlap effect, thus improving image assessment. Some studies have suggested DBT might replace DxMM with at least equivalent performance.

Objective: To evaluate the replacement of DxMM with DBT in women recalled at screening.

Methods: We searched PubMed, EMBASE, and the Cochrane Library databases to identify diagnostic paired cohort studies or RCTs comparing DBT vs DxMM, published in English that: reported accuracy outcomes, recruited women recalled for assessment at mammography screening, and included a reference standard. Subgroup analysis was performed over lesion characteristics. We provided pooled accuracy estimates and differences between tests using a quadrivariate model. We assessed the certainty of the evidence using the GRADE approach.

Results: We included ten studies that reported specificity and sensitivity. One study included 7060 women while the remaining included between 52 and 738 women. DBT compared with DxMM showed a pooled difference for the sensitivity of 2% (95% CI 1%-3%) and a pooled difference for the specificity of 6% (95%CI 2%-11%). Restricting the analysis to the six studies that included women with microcalcification lesions gave similar results. In the context of a prevalence of 21% of breast cancer (BC) in recalled women, DBT probably detects 4 (95% CI 2-6) more BC cases and has 47 (95%CI 16-87) fewer false-positive results per 1000 assessments. The certainty of the evidence was moderate due to risk of bias.

Conclusion: The evidence in the assessment of screen-recalled findings with DBT is sparse and of moderate certainty. DBT probably has higher sensitivity and specificity than DxMM. Women, health care providers and policymakers might value as relevant the reduction of false-positive results and related fewer invasive diagnostic procedures with DBT, without missing BC cases.
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http://dx.doi.org/10.1002/cam4.3803DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982617PMC
April 2021

Hospital-at-Home Expands Hospital Capacity During COVID-19 Pandemic.

J Am Med Dir Assoc 2021 Jan 31. Epub 2021 Jan 31.

Department of Nephrology, Hospital del Mar-IMIM, Barcelona, Spain.

A Coronavirus Disease 2019 (COVID-19)-specific Hospital-at-Home was implemented in a 400-bed tertiary hospital in Barcelona, Spain. Senior or immune-compromised physicians oversaw patient care. The alternative to inpatient care more than doubled beds available for hospitalization and decreased the risk of transmission among patients and health care professionals. Mild cases from either the emergency department or after hospital discharge were deemed suitable for admission to the Hospital-at-Home. More than half of all patients had pneumonia. Standardized protocols and management criteria were provided. Only 6% of cases required referral for inpatient hospitalization. These results are promising and may provide valuable insight for centers undertaking Hospital-at-Home initiatives or in the case of new COVID-19 outbreaks.
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http://dx.doi.org/10.1016/j.jamda.2021.01.077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7847393PMC
January 2021

Epidemiology of drug-related deaths in European hospitals: A systematic review and meta-analysis of observational studies.

Br J Clin Pharmacol 2021 Feb 24. Epub 2021 Feb 24.

Department of Medical Sciences, University of Girona, Girona, Spain.

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http://dx.doi.org/10.1111/bcp.14799DOI Listing
February 2021

Effects of Environmental Factors on Severity and Mortality of COVID-19.

Front Med (Lausanne) 2020 20;7:607786. Epub 2021 Jan 20.

Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia.

Most respiratory viruses show pronounced seasonality, but for SARS-CoV-2, this still needs to be documented. We examined the disease progression of COVID-19 in 6,914 patients admitted to hospitals in Europe and China. In addition, we evaluated progress of disease symptoms in 37,187 individuals reporting symptoms into the COVID Symptom Study application. Meta-analysis of the mortality risk in seven European hospitals estimated odds ratios per 1-day increase in the admission date to be 0.981 (0.973-0.988, < 0.001) and per increase in ambient temperature of 1°C to be 0.854 (0.773-0.944, = 0.007). Statistically significant decreases of comparable magnitude in median hospital stay, probability of transfer to the intensive care unit, and need for mechanical ventilation were also observed in most, but not all hospitals. The analysis of individually reported symptoms of 37,187 individuals in the UK also showed the decrease in symptom duration and disease severity with time. Severity of COVID-19 in Europe decreased significantly between March and May and the seasonality of COVID-19 is the most likely explanation.
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http://dx.doi.org/10.3389/fmed.2020.607786DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855590PMC
January 2021

Breast density, benign breast disease, and risk of breast cancer over time.

Eur Radiol 2021 Jan 6. Epub 2021 Jan 6.

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Passeig Marítim 25-29, 08003, Barcelona, Spain.

Objectives: Assessing the combined effect of mammographic density and benign breast disease is of utmost importance to design personalized screening strategies.

Methods: We analyzed individual-level data from 294,943 women aged 50-69 years with at least one mammographic screening participation in any of four areas of the Spanish Breast Cancer Screening Program from 1995 to 2015, and followed up until 2017. We used partly conditional Cox models to assess the association between benign breast disease, breast density, and the risk of breast cancer.

Results: During a median follow-up of 8.0 years, 3697 (1.25%) women had a breast cancer diagnosis and 5941 (2.01%) had a benign breast disease. More than half of screened women had scattered fibroglandular density (55.0%). The risk of breast cancer independently increased with the presence of benign breast disease and with the increase in breast density (p for interaction = 0.84). Women with benign breast disease and extremely dense breasts had a threefold elevated risk of breast cancer compared with those with scattered fibroglandular density and without benign breast disease (hazard ratio [HR] = 3.07; 95%CI = 2.01-4.68). Heterogeneous density and benign breast disease was associated with nearly a 2.5 elevated risk (HR = 2.48; 95%CI = 1.66-3.70). Those with extremely dense breast without a benign breast disease had a 2.27 increased risk (95%CI = 2.07-2.49).

Conclusions: Women with benign breast disease had an elevated risk for over 15 years independently of their breast density category. Women with benign breast disease and dense breasts are at high risk for future breast cancer.

Key Points: • Benign breast disease and breast density were independently associated with breast cancer. • Women with benign breast disease had an elevated risk for up to 15 years independently of their mammographic density category.
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http://dx.doi.org/10.1007/s00330-020-07490-5DOI Listing
January 2021

Risk of breast cancer two years after a benign biopsy depends on the mammographic feature prompting recall.

Maturitas 2021 Feb 4;144:53-59. Epub 2020 Nov 4.

Institut Hospital del Mar d'Investigacions Mèdiques (IMIM). Dr. Aiguader 88, 08003, Barcelona, Spain; Research Network on Health Services in Chronic Diseases (REDISSEC), Barcelona, Spain.

Objective: We aimed to explore whether the type of mammographic feature prompting a false-positive recall (FPR) during mammography screening influences the risk and timing of breast cancer diagnosis, particularly if assessed with invasive procedures.

Study Design: We included information on women screened and recalled for further assessment in Spain between 1994 and 2015, with follow-up until 2017, categorizing FPRs by the assessment (noninvasive or invasive) and mammographic feature prompting the recall.

Main Outcome Measures: Breast cancer rates in the first two years after FPR (first period) and after two years (second period).

Results: The study included 99,825 women with FPRs. In both periods, the breast cancer rate was higher in the invasive assessment group than in the noninvasive group (first period 12 ‰ vs 1.9 ‰, p < 0.001; second period 4.4‰ vs 3.1‰, p < 0.001). During the first period, the invasive assessment group showed diverse breast cancer rates for each type of mammographic feature, with a higher rate for asymmetric density (31.9‰). When the second period was compared with the first, the breast cancer rate decreased in the invasive assessment group (from 12‰ to 4.4‰, p < 0.001) and increased in the noninvasive assessment group (from 1.9‰ to 3.1‰, p < 0.001).

Conclusion: In the context of mammography screening, the risk of breast cancer diagnosis during the first two years after FPR was particularly high for women undergoing invasive assessment; importantly, the risk was modified by type of mammographic feature prompting the recall. This information could help to individualize follow-up after exclusion of malignancy.
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http://dx.doi.org/10.1016/j.maturitas.2020.10.024DOI Listing
February 2021

Factors that Influence Treatment Delay for Patients with Breast Cancer.

Ann Surg Oncol 2020 Nov 27. Epub 2020 Nov 27.

Research Unit, Agencia Sanitaria Costa del Sol, Hospital Costa del Sol University of Málaga, Marbella, Spain.

Introduction: The diagnosis or treatment of breast cancer is sometimes delayed. A lengthy delay may have a negative psychological impact on patients. The aim of our study was to evaluate the sociodemographic, clinical and pathological factors associated with delay in the provision of surgical treatment for localised breast cancer, in a prospective cohort of patients.

Methods: This observational, prospective, multicentre study was conducted in ten hospitals belonging to the Spanish national public health system, located in four Autonomous Communities (regions). The study included 1236 patients, diagnosed through a screening programme or found to be symptomatic, between April 2013 and May 2015. The study variables analysed included each patient's personal history, care situation, tumour history and data on the surgical intervention, pathological anatomy, hospital admission and follow-up. Treatment delay was defined as more than 30 days elapsed between biopsy and surgery.

Results: Over half of the study population experienced surgical treatment delay. This delay was greater for patients with no formal education and among widows, persons not requiring assistance for usual activities, those experiencing anxiety or depression, those who had a high BMI or an above-average number of comorbidities, those who were symptomatic, who did not receive NMR spectroscopy, who presented a histology other than infiltrating ductal carcinoma or who had poorly differentiated carcinomas.

Conclusions: Certain sociodemographic and clinical variables are associated with surgical treatment delay. This study identifies factors that influence surgical delays, highlighting the importance of preventing these factors and of raising awareness among the population at risk and among health personnel.
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http://dx.doi.org/10.1245/s10434-020-09409-2DOI Listing
November 2020

Quality of Life in a Cohort of 1078 Women Diagnosed with Breast Cancer in Spain: 7-Year Follow-Up Results in the MCC-Spain Study.

Int J Environ Res Public Health 2020 11 13;17(22). Epub 2020 Nov 13.

CIBER Epidemiologia y Salud Pública (CIBERESP), 28029 Madrid, Spain.

Breast cancer is the most frequent cause of tumors and net survival is increasing. Achieving a higher survival probability reinforces the importance of studying health-related quality of life (HR-QoL). The main aim of this work is to test the relationship between different sociodemographic, clinical and tumor-intrinsic characteristics, and treatment received with HR-QoL measured using SF-12 and the FACT/NCCN (National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy) Breast Symptom Index (FBSI). Women with breast cancer recruited between 2008 and 2013 and followed-up until 2017-2018 in a prospective cohort answered two HR-QoL surveys: the SF-12 and FBSI. The scores obtained were related to woman and tumor characteristics using linear regression models. The telephone survey was answered by 1078 women out of 1685 with medical record follow-up (64%). Increases in all three HR-QoL scores were associated with higher educational level. The score differences between women with university qualifications and women with no schooling were 5.43 for PCS-12, 6.13 for MCS-12 and 4.29 for FBSI. Histological grade at diagnosis and recurrence in the follow-up displayed a significant association with mental and physical HR-QoL, respectively. First-line treatment received was not associated with HR-QoL scores. On the other hand, most tumor characteristics were not associated with HR-QoL. As breast cancer survival is improving, further studies are needed to ascertain if these differences still hold in the long run.
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http://dx.doi.org/10.3390/ijerph17228411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7696097PMC
November 2020

Composition of the immunoglobulin G glycome associates with the severity of COVID-19.

Glycobiology 2020 Nov 10. Epub 2020 Nov 10.

Genos Glycoscience Research Laboratory, 10000 Zagreb, Croatia.

A large variation in the severity of disease symptoms is one of the key open questions in COVID-19 pandemics. The fact that only a small subset of people infected with SARS-CoV-2 develop severe disease suggests that there have to be some predisposing factors, but biomarkers that reliably predict disease severity have not been found so far. Since overactivation of the immune system is implicated in a severe form of COVID-19 and the IgG glycosylation is known to be involved in the regulation of different immune processes, we evaluated the association of inter-individual variation in IgG N-glycome composition with the severity of COVID-19. The analysis of 166 severe and 167 mild cases from hospitals in Spain, Italy and Portugal revealed statistically significant differences in the composition of the IgG N-glycome. The most notable difference was the decrease in bisecting N-acetylglucosamine (GlcNAc) in severe patients from all three cohorts. IgG galactosylation was also lower in severe cases in all cohorts, but the difference in galactosylation was not statistically significant after correction for multiple testing.
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http://dx.doi.org/10.1093/glycob/cwaa102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717252PMC
November 2020

Readmissions and complications in breast ductal carcinoma in situ: A retrospective study comparing screen- and non-screen-detected patients.

Womens Health (Lond) 2020 Jan-Dec;16:1745506520965899

Department of Epidemiology and Evaluation, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.

Objective: Population-wide mammographic screening programs aim to reduce breast cancer mortality. However, a broad view of the harms and benefits of these programs is necessary to favor informed decisions, especially in the earliest stages of the disease. Here, we compare the outcomes of patients diagnosed with breast ductal carcinoma in situ in participants and non-participants of a population-based mammographic screening program.

Methods: A retrospective cohort study of all patients diagnosed with breast ductal carcinoma in situ between 2000 and 2010 within a single hospital. A total of 211 patients were included, and the median follow-up was 8.4 years. The effect of detection mode (screen-detected and non-screen-detected) on breast cancer recurrences, readmissions, and complications was evaluated through multivariate logistic regression analysis.

Results: In the majority of women, breast ductal carcinoma in situ was screen-detected (63.5%). Screen-detected breast ductal carcinoma in situ was smaller in size compared to those non-screen-detected (57.53% < 20 mm versus 78.03%, p = 0.002). Overall, breast-conserving surgery was the most frequent surgery (86.26%); however, mastectomy was higher in non-screen-detected breast ductal carcinoma in situ (20.78% versus 9.7%, p = 0.024). Readmissions for mastectomy were more frequent in non-screen-detected breast ductal carcinoma in situ. Psychological complications, such as fatigue, anxiety, and depression, had a prevalence of 15% within our cohort. Risk of readmissions and complications was higher within the non-screen-detected group, as evidenced by an odds ratio = 6.25 (95% confidence interval = 1.95-19.99) for readmissions and an odds ratio = 2.41 (95% confidence interval = 1.95-4.86) for complications.

Conclusions: Our findings indicate that women with breast ductal carcinoma in situ breast cancer diagnosed through population-based breast cancer screening program experience a lower risk of readmissions and complications than those diagnosed outside these programs. These findings can help aid women and health professionals make informed decisions regarding screening.
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http://dx.doi.org/10.1177/1745506520965899DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594253PMC
October 2020

Differences in breast cancer risk after benign breast disease by type of screening diagnosis.

Breast 2020 Dec 3;54:343-348. Epub 2020 Oct 3.

IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Research Network on Health Services in Chronic Diseases (REDISSEC), Barcelona, Spain; Servei D'Epidemiologia I Avaluació, Hospital Del Mar, Barcelona, Spain. Electronic address:

Introduction: We aimed to assess differences in breast cancer risk across benign breast disease diagnosed at prevalent or incident screens.

Materials And Methods: We conducted a retrospective cohort study with data from 629,087 women participating in a long-standing population-based breast cancer screening program in Spain. Each benign breast disease was classified as non-proliferative, proliferative without atypia, or proliferative with atypia, and whether it was diagnosed in a prevalent or incident screen. We used partly conditional Cox hazard regression to estimate the adjusted hazard ratios of the risk of breast cancer.

Results: Compared with women without benign breast disease, the risk of breast cancer was significantly higher (p-value = 0.005) in women with benign breast disease diagnosed in an incident screen (aHR, 2.67; 95%CI: 2.24-3.19) than in those with benign breast disease diagnosed in a prevalent screen (aHR, 1.87; 95%CI: 1.57-2.24). The highest risk was found in women with a proliferative benign breast disease with atypia (aHR, 4.35; 95%CI: 2.09-9.08, and 3.35; 95%CI: 1.51-7.40 for those diagnosed at incident and prevalent screens, respectively), while the lowest was found in women with non-proliferative benign breast disease (aHR, 2.39; 95%CI: 1.95-2.93, and 1.63; 95%CI: 1.32-2.02 for those diagnosed at incident and prevalent screens, respectively).

Conclusion: Our study showed that the risk of breast cancer conferred by a benign breast disease differed according to type of screen (prevalent or incident). To our knowledge, this is the first study to analyse the impact of the screening type on benign breast disease prognosis.
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http://dx.doi.org/10.1016/j.breast.2020.09.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7770442PMC
December 2020

Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population-based cohort study.

BMJ Open 2020 09 9;10(9):e040253. Epub 2020 Sep 9.

Department of Epidemiology and Evaluation, Hospital del Mar Institute for Medical Research, Barcelona, Barcelona, Spain

Introduction: Breast cancer has become a chronic disease due to survival improvement and the need to monitor the side effects of treatment and the disease itself. The aim of the SURBCAN study is to describe comorbidity, healthcare services use and adherence to preventive recommendations in long-term breast cancer survivors and to compare them with those in women without this diagnosis in order to improve and adapt the care response to this group of survivors.

Methods And Analysis: Population-based retrospective cohort study using real-world data from cancer registries and linked electronic medical records in five Spanish regions. Long-term breast cancer survivors diagnosed between 2000 and 2006 will be identified and matched by age and administrative health area with women without this diagnosis. Sociodemographic and clinical variables including comorbidities and variables on the use of health services between 2012 and 2016 will be obtained from databases in primary and hospital care. Health services use will be assessed through the annual number of visits to primary care professionals and to specialists and through annual imaging and laboratory tests. Factors associated with healthcare utilisation and comorbidities will be analysed using multilevel logistic regression models. Recruitment started in December 2018.

Ethics And Dissemination: This study was approved by the Ethics Committee of Parc de Salut Mar. The results of the study will be published in a peer-reviewed journal and will be presented at national and international scientific conferences and at patient associations.

Trial Registration Number: This protocol is registered in Clinical Trials.gov (identifier: NCT03846999).
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http://dx.doi.org/10.1136/bmjopen-2020-040253DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7482495PMC
September 2020

Monitoring and evaluation of breast cancer screening programmes: selecting candidate performance indicators.

BMC Cancer 2020 Aug 24;20(1):795. Epub 2020 Aug 24.

Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.

Background: In the scope of the European Commission Initiative on Breast Cancer (ECIBC) the Monitoring and Evaluation (M&E) subgroup was tasked to identify breast cancer screening programme (BCSP) performance indicators, including their acceptable and desirable levels, which are associated with breast cancer (BC) mortality. This paper documents the methodology used for the indicator selection.

Methods: The indicators were identified through a multi-stage process. First, a scoping review was conducted to identify existing performance indicators. Second, building on existing frameworks for making well-informed health care choices, a specific conceptual framework was developed to guide the indicator selection. Third, two group exercises including a rating and ranking survey were conducted for indicator selection using pre-determined criteria, such as: relevance, measurability, accurateness, ethics and understandability. The selected indicators were mapped onto a BC screening pathway developed by the M&E subgroup to illustrate the steps of BC screening common to all EU countries.

Results: A total of 96 indicators were identified from an initial list of 1325 indicators. After removing redundant and irrelevant indicators and adding those missing, 39 candidate indicators underwent the rating and ranking exercise. Based on the results, the M&E subgroup selected 13 indicators: screening coverage, participation rate, recall rate, breast cancer detection rate, invasive breast cancer detection rate, cancers > 20 mm, cancers ≤10 mm, lymph node status, interval cancer rate, episode sensitivity, time interval between screening and first treatment, benign open surgical biopsy rate, and mastectomy rate.

Conclusion: This systematic approach led to the identification of 13 BCSP candidate performance indicators to be further evaluated for their association with BC mortality.
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http://dx.doi.org/10.1186/s12885-020-07289-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444070PMC
August 2020

Comorbidities and Mortality in Patients With COVID-19 Aged 60 Years and Older in a University Hospital in Spain.

Arch Bronconeumol 2020 11 16;56(11):756-758. Epub 2020 Jul 16.

Department of Epidemiology and Evaluation, Hospital del Mar-IMIM, Barcelona, Spain; Research Network on Health Services in Chronic Diseases (REDISSEC), Barcelona, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.arbres.2020.06.012DOI Listing
November 2020

Characterization of Burnout Among Spanish Family Physicians Treating Fibromyalgia Patients: The EPIFFAC Study.

J Am Board Fam Med 2020 May-Jun;33(3):386-396

From Unitat de Fibromiàlgia, Servei de Reumatologia, ICEMEQ, Hospital Clínic de Barcelona, Barcelona, Spain (BO, AC, EG, AA); Unitat de Fibromiàlgia, Servei de Psiquiatria i Psicologia, Institut Clínic de Neurociències, Hospital Clínic de Barcelona, Barcelona, Spain (XT); Joan XXIII University Hospital, Tarragona, Spain (ES); Unidad de Gestión Clínica Bajo Andarax, Almería, Spain (JV); Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain (XC).

Objective: Burnout among physicians has increased, affecting not only doctors but also the quality of patient care. Treating challenging disorders, such as fibromyalgia, may increase the risk of feeling burned out. Health care of fibromyalgia patients is increasingly being assigned to family physicians. Therefore, we described the demographic characteristics, work contexts, component burnout scores (exhaustion, depersonalization, and personal accomplishment), and perceptions of fibromyalgia care of Spanish family medicine physicians with high and low levels of burnout. We then evaluated which of these variables were associated with having high or low levels of burnout.

Method: This cross-sectional study assessed 506 family physicians recruited from the Spanish Society of Family Physicians and randomly selected from Primary Health Care Centers. The subgrouping of family physicians based on their burnout scores was assessed by cluster analysis. Variables showing statistically significant differences between clusters and significance below 0.25 in univariate logistic regressions were assessed by multivariate logistic regression analysis.

Results: Family physicians reporting higher burnout scores (25%) felt that fibromyalgia patients on sick leave increased their workload, reported no support from nurses in the treatment of fibromyalgia patients, and had a more negative impression of fibromyalgia patients.

Conclusions: One-quarter of family physicians reported feeling exhausted, detached from fibromyalgia patients, or less professionally accomplished. Several personal characteristics and contextual variables increased burnout. Several interventions to modify these variables and, thus, protect family physicians treating fibromyalgia from burnout are suggested.
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http://dx.doi.org/10.3122/jabfm.2020.03.190201DOI Listing
June 2019

Relationship Between Treatment Duration and Efficacy of Pharmacological Treatment for ADHD: A Meta-Analysis and Meta-Regression of 87 Randomized Controlled Clinical Trials.

J Atten Disord 2020 Feb 20:1087054720903372. Epub 2020 Feb 20.

University of Girona, Spain.

To determine the relationship between treatment duration and the efficacy of pharmacological treatment for reducing ADHD symptoms. We conducted a systematic review of randomized, double-blind, placebo-controlled clinical trials investigating the efficacy of pharmacological interventions in patients with ADHD. The last bibliographic search was performed in April 15, 2019. The effect of treatment duration on efficacy was studied using meta-regression. A total of 87 studies lasting from 3 to 28 weeks were included. Pharmacological treatment improved ADHD symptom severity by -7.35 points. Treatment duration did not moderate the efficacy of pharmacological treatment. Consistent results were found for psychostimulant drugs, methylphenidate, amphetamine derivatives, atomoxetine, and α2-agonists. A negative correlation was found between baseline ADHD severity efficacy (Coefficient = -.250, = .013). The efficacy of pharmacological treatment for ADHD remains stable over time. A greater efficacy in more severe patients is suggested.
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http://dx.doi.org/10.1177/1087054720903372DOI Listing
February 2020

Exploring the Role of Breast Density on Cancer Prognosis among Women Attending Population-Based Screening Programmes.

J Oncol 2019 27;2019:1781762. Epub 2019 Nov 27.

IMIM (Hospital del Mar Medical Research Institute), Passeig Marítim, 25-29, 08003 Barcelona, Spain.

Background: Our aim was to assess the role of breast density on breast cancer mortality and recurrences, considering patient and tumour characteristics and the treatments received among women attending population-based screening programmes.

Methods: We conducted a retrospective cohort study among women aged 50-69 years attending population-based screening programmes, diagnosed with invasive breast cancer between 2000 and 2009, and followed up to 2014. Breast density was categorised as low density (≤25% dense tissue), intermediate density (25-50%), and high density (≥50%). Cox proportional hazards regression models were fitted to estimate the adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI) for death and recurrences, adjusting by patient characteristics, mode of detection (screen-detected vs. interval cancer), and tumour features.

Results: The percentage of deaths and recurrences was higher among women with intermediate- and high-density breasts than among women with low-density breasts (=0.011 for death; =0.037 for recurrences). Adjusted Cox proportional hazards regression models revealed that women with intermediate- and high-density breasts had a higher risk of death than women with low-density breasts, being statistically significant for intermediate densities (aHR = 2.19 [95% CI: 1.16-4.13], aHR = 1.44 [95% CI: 0.67-3.1], respectively). No association was found between breast density and recurrences.

Conclusions: Breast density was associated with a higher risk of death, but not of recurrences, among women participating in breast cancer screening. These findings reinforce the need to improve screening sensitivity among women with dense breasts and to routinely assess breast density, not only for its role as a risk factor for breast cancer but also for its potential influence on cancer prognosis.
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http://dx.doi.org/10.1155/2019/1781762DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900953PMC
November 2019

Personalized breast cancer screening strategies: A systematic review and quality assessment.

PLoS One 2019 16;14(12):e0226352. Epub 2019 Dec 16.

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

Background: The effectiveness of breast cancer screening is still under debate. Our objective was to systematically review studies assessing personalized breast cancer screening strategies based on women's individual risk and to conduct a risk of bias assessment.

Methods: We followed the standard methods of The Cochrane Collaboration and PRISMA declaration and searched the MEDLINE, EMBASE and Clinical Trials databases for studies published in English. The quality of the studies was assessed using the ISPOR-AMCP-NPC Questionnaire and The Cochrane Risk of Bias Tool. Two independent reviewers screened full texts and evaluated the risk of bias.

Results: Out of the 1533 initially retrieved citations, we included 13 studies. Three studies were randomized controlled trials, while nine were mathematical modeling studies, and one was an observational pilot study. The trials are in the recruitment phase and have not yet reported their results. All three trials used breast density and age to define risk groups, and two of them included family history, previous biopsies, and genetic information. Among the mathematical modeling studies, the main risk factors used to define risk groups were breast density, age, family history, and previous biopsies. Six studies used genetic information to define risk groups. The most common outcome measures were the gain in quality-adjusted life years (QALY), absolute costs, and incremental cost-effectiveness ratio (ICER), while the main outcome in the observational study was the detection rate. In all models, personalized screening strategies were shown to be effective. The randomized trials were of good quality. The modeling studies showed moderate risk of bias but there was wide variability across studies. The observational study showed a low risk of bias but its utility was moderate due to its pilot design and its relatively small scale.

Conclusions: There is some evidence of the effectiveness of screening personalization in terms of QUALYs and ICER from the modeling studies and the observational study. However, evidence is lacking on feasibility and acceptance by the target population.

Review Registration: PROSPERO: CRD42018110483.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226352PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6913984PMC
April 2020

Factors associated with readmissions in women participating in screening programs and treated for breast cancer: a retrospective cohort study.

BMC Health Serv Res 2019 Dec 5;19(1):940. Epub 2019 Dec 5.

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Passeig Marítim, 25-29, 08003, Barcelona, Spain.

Background: We aimed to identify the risk factors associated with early, late and long-term readmissions in women diagnosed with breast cancer participating in screening programs.

Methods: We performed a multicenter cohort study of 1055 women aged 50-69 years participating in Spanish screening programs, diagnosed with breast cancer between 2000 and 2009, and followed up to 2014. Readmission was defined as a hospital admission related to the disease and/or treatment complications, and was classified as early (< 30 days), late (30 days-1 year), or long-term readmission (> 1 year). We used logistic regression to estimate the adjusted odds ratios (aOR), and 95% confidence intervals (95% CI) to explore the factors associated with early, late and long-term readmissions, adjusting by women's and tumor characteristics, detection mode, treatments received, and surgical and medical complications.

Results: Among the women included, early readmission occurred in 76 (7.2%), late readmission in 87 (8.2%), long-term readmission in 71 (6.7%), and no readmission in 821 (77.8%). Surgical complications were associated with an increased risk of early readmissions (aOR = 3.62; 95%CI: 1.27-10.29), and medical complications with late readmissions (aOR = 8.72; 95%CI: 2.83-26.86) and long-term readmissions (aOR = 4.79; 95%CI: 1.41-16.31).

Conclusion: Our results suggest that the presence of surgical or medical complications increases readmission risk, taking into account the detection mode and treatments received. Identifying early complications related to an increased risk of readmission could be useful to adapt the management of patients and reduce further readmissions.

Trial Registration: ClinicalTrials.govIdentifier: NCT03165006. Registration date: May 22, 2017 (Retrospectively registered).
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http://dx.doi.org/10.1186/s12913-019-4789-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6896282PMC
December 2019

Breast Cancer Screening and Diagnosis: A Synopsis of the European Breast Guidelines.

Ann Intern Med 2020 01 26;172(1):46-56. Epub 2019 Nov 26.

European Commission, Joint Research Centre, Ispra, Italy (D.L., E.P., Z.S.).

Description: The European Commission Initiative for Breast Cancer Screening and Diagnosis guidelines (European Breast Guidelines) are coordinated by the European Commission's Joint Research Centre. The target audience for the guidelines includes women, health professionals, and policymakers.

Methods: An international guideline panel of 28 multidisciplinary members, including patients, developed questions and corresponding recommendations that were informed by systematic reviews of the evidence conducted between March 2016 and December 2018. GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests by enhancing transparency. Questions and recommendations, expressed as strong or conditional, focused on outcomes that matter to women and provided a rating of the certainty of evidence.

Recommendations: This synopsis of the European Breast Guidelines provides recommendations regarding organized screening programs for women aged 40 to 75 years who are at average risk. The recommendations address digital mammography screening and the addition of hand-held ultrasonography, automated breast ultrasonography, or magnetic resonance imaging compared with mammography alone. The recommendations also discuss the frequency of screening and inform decision making for women at average risk who are recalled for suspicious lesions or who have high breast density.
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http://dx.doi.org/10.7326/M19-2125DOI Listing
January 2020

Impact of adjuvant chemotherapy on the survival of patients with breast cancer diagnosed by screening.

Cancer Med 2019 11 24;8(15):6662-6670. Epub 2019 Sep 24.

Department of Epidemiology and Evaluation, Hospital del Mar, Research Network on Health Services in Chronic Diseases (REDISSEC), Barcelona, Spain.

The aim of this study is to determine the survival of patients with breast cancer treated with adjuvant chemotherapy (ACh) after the diagnosis by screening, taking comorbidity into account. This multicenter cohort study examined a population of patients taking part in four national screening programs for the early detection of breast cancer (localized or locally advanced), during the period 2000-2008. Of the 1248 cancers detected, 266 were prevalent (21.3%), 633 were incident (50.7%), and 349 were interval (27.9%). No significant differences were detected between the three groups in terms of the distribution of comorbidity according to the CCI. After a median follow-up of 102 months, 22.1% of the patients with interval cancer had died. The corresponding figures for the incident and prevalent cancers were 10.4% and 7.9%, respectively (P < .001). The adjusted Cox regression analysis by the stage, CCI and group revealed no differences in the risk of recurrence between the different groups according to the ACh performed. However, there were significant differences in the overall survival; for the interval cancer group without ACh, the risk of death was higher (Hazard ratio: 2.5 [1.0-6.2]) than for the other two groups. However, for the prevalent and incident groups that did not receive ACh, there was no greater risk of death. This study shows that adjuvant chemotherapy seems to benefit patients with interval breast cancer, who have a poorer prognosis than those with prevalent or incident cancer. However, the role of ACh is unclear with respect to prevalent and incident cancers when comorbidity is taken into account.
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http://dx.doi.org/10.1002/cam4.2488DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6825992PMC
November 2019

Study of the strength of the evidence and the redundancy of the research on pharmacological treatment for Alzheimer's disease: a cumulative meta-analysis and trial sequential analysis.

Eur J Clin Pharmacol 2019 Dec 21;75(12):1659-1667. Epub 2019 Aug 21.

TransLab Research Group, University of Girona, Emili Grahit, 77, 17003, Girona, Spain.

Purpose: To study the strength of the evidence on efficacy, safety and acceptability of cholinesterase inhibitors (ChEI) and memantine for Alzheimer's disease (AD); and to determine the number of redundant post-authorisation trials.

Methods: A cumulative meta-analysis with a trial sequential analysis (TSA) was performed. Primary outcomes were cognitive function assessed with ADAS-cog or SIB scales, discontinuation due to adverse events (AE) and discontinuation for any reason. The redundancy of post-authorisation clinical trials was studied by determining the novel aspects of each study on patient, intervention, comparator and trial outcome characteristics. Two criteria of futile trial (lenient and strict) were used.

Results: A total of 63 randomised clinical trials (RCTs) (16,576 patients) were included. It was conclusive that neither ChEI nor memantine achieved clinically significant improvement in cognitive function. In relation to safety, there was sufficient evidence to conclude that donepezil caused a clinically relevant increase on dropouts due to AE whereas the evidence was inconclusive for the remaining interventions. Regarding acceptability, it was conclusive that no ChEI improved treatment discontinuation while it was uncertain for memantine. The proportion of redundant trials was 5.6% with the lenient criteria and 42.6% with the strict one.

Conclusions: The evidence is conclusive that ChEI and memantine do not achieve clinically significant symptomatic improvement in AD while the acceptability of ChEI is unsatisfactory. Although evidence on the safety of pharmacological interventions for AD and acceptability of memantine is inconclusive, no further RCTs are needed as their efficacy is not clinically relevant. Redundant trials were identified but their number depends on the criteria of futility used.
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http://dx.doi.org/10.1007/s00228-019-02742-wDOI Listing
December 2019

Methods for Development of the European Commission Initiative on Breast Cancer Guidelines: Recommendations in the Era of Guideline Transparency.

Ann Intern Med 2019 08 23;171(4):273-280. Epub 2019 Jul 23.

European Commission, Joint Research Centre, Ispra, Italy (D.L., N.D., Z.S.).

Neither breast cancer prevention and early-detection programs, nor their outcomes, are uniform across Europe. This article describes the rationale, methods, and process for development of the European Commission (EC) Initiative on Breast Cancer Screening and Diagnosis Guidelines. To be consistent with standards set by the Institute of Medicine and others, the EC followed 6 general principles. First, the EC selected, via an open call, a panel with broad representation of areas of expertise. Second, it ensured that all recommendations were supported by systematic reviews. Third, the EC separately considered important subgroups of women, included patient advocates in the guidelines development group, and focused on good communication to inform women's decisions. Fourth, EC rules on conflicts of interest were followed and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests. Fifth, it focused its recommendations on outcomes that matter to women, and certainty of the evidence is rated for each. Sixth, the EC elicited stakeholder feedback to ensure that the recommendations remain up to date and relevant to practice. This article describes the approach and highlights ways of disseminating and adapting the recommendations both within and outside Europe, using innovative information technology tools.
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http://dx.doi.org/10.7326/M18-3445DOI Listing
August 2019

Cost-Effectiveness of the Screening for the Primary Prevention of Fragility Hip Fracture in Spain Using FRAX.

Calcif Tissue Int 2019 09 6;105(3):263-270. Epub 2019 Jun 6.

Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Barcelona, Spain.

To assess the cost-effectiveness of the primary prevention of fragility hip fractures through opportunistic risk-based screening using FRAX among women aged 70 to 89 years, and the subsequent treatment with alendronate in women at high-risk, from the Spanish national health system perspective. We performed a discrete-event simulation model. Women were categorized in low, intermediate and high-risk of fragility hip fracture through screening based on the FRAX risk assessment tool score (Spanish version). Low-risk women received lifestyle recommendations whereas the high-risk group was assigned to alendronate treatment. For women at intermediate-risk, treatment decision was based on a recalculated score considering bone mineral density (BMD). The cost-effectiveness analysis tested six scenarios defined by different FRAX cut-off values assessing the incremental costs per averted fracture in 20 years. Deterministic sensitivity analysis was performed. We included a random sample of 5146 women obtained from a Spanish cohort of women referred for BMD. The most cost-effective intervention had an Incremental Cost-effectiveness Ratio (ICER) of 57,390 € per averted hip fracture and consisted of using the FRAX score without BMD and treating women with a score higher than 5%. The ICER exceeded the acceptability threshold of 25,000 € in all the scenarios. Sensitivity analysis based on time to fracture, treatment efficacy, adherence to treatment and cost of dependence resulted in ICERs ranging from 39,216 € to 254,400 €. An ICER of 24,970 € was obtained when alendronate cost was reduced to 1.13 € per month. The use of FRAX as screening tool followed by alendronate treatment is not cost-effective in senior women in Spain. Other primary preventions strategies are advisable.
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http://dx.doi.org/10.1007/s00223-019-00570-9DOI Listing
September 2019

Changes in mammographic density over time and the risk of breast cancer: An observational cohort study.

Breast 2019 Aug 13;46:108-115. Epub 2019 May 13.

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain; Research Network on Health Services in Chronic Diseases (REDISSEC), Barcelona, Spain. Electronic address:

Background: The effect of changes in mammographic density over time on the risk of breast cancer remains inconclusive.

Methods: We used information from four centres of the Breast Cancer Screening Program in Spain in the period 1996-2015. We analysed individual level data from 117,388 women first screened age 50-54, with at least two screening examinations. Breast density was determined using the BI-RADS classification (A to D in increasing order) at earliest and latest screening examination. Adjusted Poisson regression models were used to estimate the relative risk (RR) and 95% confidence intervals (95%CI) of the association between changes in mammographic density and breast cancer risk over time.

Results: During an average 5.8 years of follow-up, 1592 (1.36%) women had a breast cancer diagnosis. An increase in density category increased breast cancer risk, and a decrease in density decreased the risk, compared with women who remained in the same BI-RADS category. Women whose density category increased from B to C or B to D had a RR of 1.55 (95%CI = 1.24-1.94) and 2.32 (95%CI = 1.48-3.63), respectively. The RR for women whose density increased from C to D was 1.51 (95%CI = 1.03-2.22). Changes in BI-RADS density were similarly associated with the risk for invasive cancer than for ductal carcinoma in situ.

Conclusions: Although a modest proportion of women changed BI-RADS density category, mammographic density changes modulated the risk of breast cancer and identified women at a differential risk. Using two longitudinal measures of BI-RADS density could help target women for risk-based screening strategies.
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http://dx.doi.org/10.1016/j.breast.2019.04.007DOI Listing
August 2019

Correction to: Health care services use among long-term breast cancer survivors: a systematic review.

J Cancer Surviv 2019 Jun;13(3):494

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Passeig Marítim, 25-29, 08003, Barcelona, Spain.

The article Health care services use among long-term breast cancer survivors: a systematic review, written by Anna Jansana, Margarita Posso, Inmaculada Guerrero, Alexandra Prados-Torres, Maria Isabel Del Cura, Xavier Castells and Maria Sala, was originally published electronically.
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http://dx.doi.org/10.1007/s11764-019-00763-zDOI Listing
June 2019

A systematic review and quality assessment of individualised breast cancer risk prediction models.

Br J Cancer 2019 07 22;121(1):76-85. Epub 2019 May 22.

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

Background: Individualised breast cancer risk prediction models may be key for planning risk-based screening approaches. Our aim was to conduct a systematic review and quality assessment of these models addressed to women in the general population.

Methods: We followed the Cochrane Collaboration methods searching in Medline, EMBASE and The Cochrane Library databases up to February 2018. We included studies reporting a model to estimate the individualised risk of breast cancer in women in the general population. Study quality was assessed by two independent reviewers. Results are narratively summarised.

Results: We included 24 studies out of the 2976 citations initially retrieved. Twenty studies were based on four models, the Breast Cancer Risk Assessment Tool (BCRAT), the Breast Cancer Surveillance Consortium (BCSC), the Rosner & Colditz model, and the International Breast Cancer Intervention Study (IBIS), whereas four studies addressed other original models. Four of the studies included genetic information. The quality of the studies was moderate with some limitations in the discriminative power and data inputs. A maximum AUROC value of 0.71 was reported in the study conducted in a screening context.

Conclusion: Individualised risk prediction models are promising tools for implementing risk-based screening policies. However, it is a challenge to recommend any of them since they need further improvement in their quality and discriminatory capacity.
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http://dx.doi.org/10.1038/s41416-019-0476-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738106PMC
July 2019