Montse Soriano-Gabarro

Bayer · Epidemiology

To understand industry practices and challenges when submitting patient experience data (PED) for regulatory decisions by the US Food and Drug Administration (FDA). A two-part online survey related to collection, submission, and use of PED by FDA in regulatory decision-making (part 1) and a best-worst exercise for prioritizing potential PED initiat...

Purpose To evaluate time trends in the prevalence of antithrombotic and statin use in four European countries. Methods Using population-based data from the United Kingdom, Denmark, Spain and Italy between 2010 and 2018, we calculated standardized annual prevalence proportions of antithrombotics and statin use, and changes in prevalence proportions...

Background Low-dose aspirin therapy reduces the risk of cardiovascular disease and may have a positive effect on the prevention of colorectal cancer. We evaluated the population-level expected effect of regular low-dose aspirin use on cardiovascular disease (CVD), colorectal cancer (CRC), gastrointestinal bleeding, symptomatic peptic ulcers, and in...

Background Patients taking low-dose aspirin to prevent cardiovascular disease (CVD) may also benefit from a reduced risk of colorectal cancer (CRC).Objective The aim was to examine the preferences of people eligible for preventive treatment with low-dose aspirin and the trade-offs they are willing to make between CVD prevention, CRC prevention, and...

Importance Population-based East Asian data have corroborated reports from non-Asian settings on the association between low-dose aspirin and a lower risk of colorectal cancer (CRC). Objective To evaluate the association between duration and recency of low-dose aspirin use and CRC risk. Design, Setting, and Participants This nested case-control s...

Background Regular use of low-dose aspirin (LDA) has been shown to reduce the risk of cardiovascular disease (CVD). Recent evidence indicates that regular LDA use also reduces the risk of colorectal cancer (CRC). Use of LDA has also been associated with an increased risk of gastrointestinal (GI) bleeding, peptic ulcers and intracranial hemorrhage (...

Background Low-dose aspirin is effective in the prevention of ischemic vascular events and studies have shown a preventative effect on colorectal cancer (CRC). However, adherence to therapy is likely an important factor for these benefits to be seen and non-adherence is associated with sub-optimal outcomes. Purpose To assess the long-term adherenc...

Background Low-dose aspirin is effective in the prevention of ischemic vascular events and studies have shown a preventative effect on colorectal cancer (CRC). Discontinuation of low-dose aspirin is associated with increased risk of ischaemic vascular events. However, data on long-term persistence to low-dose aspirin from routine clinical practice...

Background Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications. Study design and methods The European rivaroxaban epidemiological post-authorization safety study (PASS) program consists of seven complementary observational studies. For four of the studies, data are obtained from healthcare data...

Randomized controlled trials (RCTs) have strong internal validity but often have limited external validity. Observational studies have good generalizability and an increasing role in key healthcare decision making. We compared incidence rates of intracranial and major gastrointestinal bleeds in the low-dose aspirin arm (N = 9126) of the COMPASS dou...

Aim: This reports some of the first incidence rate (IR) estimates of second primary malignancies (SPMs) in men with metastatic castration-resistant prostate cancer (mCRPC) in three countries. Patients & methods: Claims data from the German Pharmacoepidemiological Research Database; registry data from the Prostate Cancer Data Base Sweden; and combin...

There is increasing interest regarding potential protective effects of low‐dose aspirin against various gastrointestinal cancers. We aimed to quantify the association between use of low‐dose aspirin and risk of gastric/oesophageal cancer using a population‐based primary care database in the UK. Between January 2005 and December 2015, we identified...

Estimates of the effect of proton pump inhibitors (PPIs) on risks of upper and lower gastrointestinal bleeding (UGIB and LGIB) among low-dose aspirin users in routine clinical practice are variable (UGIB) or lacking (LGIB). We aimed to establish these risks in the same observational study population. Using UK primary care data, we followed 199,049...

Background Among prostate cancer (PC) patients, over 90% of distant metastases occur in the bone. PC treatments may be associated with side effects, including second primary malignancies (SPM). There is limited information on the incidence of SPM among men with bone metastatic PC (mPC) and among men with bone metastatic castration-resistant PC (mCR...

Background Evidence suggests that low-dose aspirin is associated with a 30–40% protective effect against colorectal cancer (CRC) yet its effect on other gastrointestinal cancers has been less studied. We aimed to quantify the association between use of low-dose aspirin and risk of gastric/ oesophageal cancer using a population-based primary care da...

Background Meta-analysis of trial data suggests that in primary cardiovascular disease (CVD) prevention bodyweight modifies low-dose aspirin's effects on colorectal cancer (CRC) and major bleeding risk. We sought to investigate whether these effects are seen in patients with or without CVD in routine clinical practice by undertaking sub-analyses of...

Background and objective: Skeletal-related events (SREs) are common in men with bone metastases and have negative consequences for patients with castration-resistant prostate cancer (CRPC), including pain, reduced quality of life, and increased mortality. We estimated incidence rates of first SREs in a cohort of men with CRPC in the Surveillance,...

[This corrects the article DOI: 10.1155/2019/4387415.].

Objectives To estimate the prevalence of prostate cancer with bone metastasis in Beijing, and to estimate hospital visits and direct treatment costs among male urban employees with the disease in Beijing. Design Cross-sectional observational study. Setting and participants Patients with prostate cancer and bone metastasis from the Urban Employee...

Objectives: The effectiveness of risk minimization measures (RMMs) requires evaluation. This study aims to evaluate the results of cross-sectional surveys assessing the effectiveness of RMMs in Europe (EU RM Surveys) and review the regulatory consequences. Methods: The authors searched for study reports and manuscripts of completed EU RM surveys in...

Introduction: Risks of low-dose aspirin-associated upper and lower gastrointestinal bleeds (UGIB/LGIB) may vary by severity and presence of cardiovascular disease (CVD). No study has quantified these risks for UGIB and LGIB in the same real-world study population. Patients and methods: Using UK primary care data, 199,049 new users of low-dose aspir...

Background: New therapies for castration-resistant prostate cancer (CRPC) may be associated with increased risk of second primary malignancies (SPM). We therefore estimated the population-based incidence of SPM among patients with CRPC in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. We also estimated the proportion of...

188 Background: Skeletal-related events (SREs) are common in men with bone metastases and have negative consequences for patients with castration-resistant prostate cancer (CRPC), including pain, reduced quality of life, and increased risk of death. Published data on background rates of SREs in men with CPRC in real-world practice are sparse. Metho...

Figure S1. Most frequently included European Union countries in cross‐sectional surveys evaluating the effectiveness of risk minimization measures.

Figure S2. Most frequent European Union countries for risk minimization effectiveness studies using secondary data sources.

Background & aims: There are few data on the incidence of upper and lower gastrointestinal bleeding (UGIB and LGIB) from observational studies of low-dose aspirin users. We aimed to estimate incidence rates of UGIB and LGIB in a large cohort of new users of low-dose aspirin in the United Kingdom, with sub-analyses of hospitalization status and fat...

Purpose To evaluate misclassification of intracranial bleeding (ICB) onset in The Health Improvement Network and assess its impact on risk associated with low‐dose aspirin preventive therapy. Methods A total of 199 049 new users of low‐dose aspirin and 1:1 matched non‐users were followed to identify incident ICB cases with validation involving man...

Abstract Background Cancer registry data show that survival of colorectal cancer (CRC) in the United Kingdom is poor compared with other European countries and the United States, yet these data sources lack information on patient comorbidities and medication use, which could help explain these differences. Methods Among individuals aged 40–89 years...

Background Evidence regarding the chemo-protective effects of aspirin has influenced expert opinion in favour of low-dose aspirin use in certain patient populations without cardiovascular disease (CVD). The effects of aspirin in reducing the incidence of colorectal cancer (CRC) may be a large contributor to this favourable risk–benefit profile of l...

Objective: To quantify the risk of intracranial bleeds (ICBs) associated with new use of prophylactic low-dose aspirin using a population-based primary care database in the United Kingdom. Methods: A cohort of new users of low-dose aspirin (75-300 mg; n = 199,079) aged 40-84 years and a 1:1 matched cohort of nonusers of low-dose aspirin at basel...

Purpose An important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and t...

Background Evidence from clinical trial populations suggests low-dose aspirin reduces the risk of colorectal cancer (CRC). Part of this reduction in risk might be due to protection against metastatic disease. Methods We investigated the risk of CRC among new-users of low-dose aspirin (75–300 mg), including risk by stage at diagnosis. Using The Hea...

e13080 Background: A number of population-based epidemiological studies have been conducted to estimate incidence rates of SPM (newly detected malignancies) among cancer survivors, including those with prostate cancer. However, such data in patients with CRPC are limited. This study was conducted to estimate the incidence of SPM and overall surviva...

Introduction Mesothelioma is a malignant deadly disease primarily caused by exposure to asbestos. Previous studies have used simple modelling strategies to evaluate the burden of unreported mesothelioma. We built on previous work by creating a predictive multivariate regression model that incorporates novel data sources to improve the accuracy of e...

Purpose The risk of venous thromboembolism (VTE) recurrence is high following an initial VTE event, and it persists over time. This recurrence risk decreases rapidly after starting with anticoagulation treatment and reduces by ~80%–90% with prolonged anticoagulation. Nonpersistence with anticoagulants could lead to increased risk of VTE recurrence....

Background: Uterine fibroids (UFs) are the most common benign tumour in women, and many undergo hysterectomy or uterus-preserving procedures (UPPs) to manage their symptoms. We aimed to validate the recording of UFs in a primary care database, The Health Improvement Network (THIN), and to determine the incidence of UFs in the UK. Methods: In thi...

Background: We conducted three differently designed nested case-control studies to evaluate whether the protective effect of low-dose aspirin against colorectal cancer (CRC) is explained by selection bias. Methods: Using a large validated UK primary care database, we followed different cohorts of patients, who varied in their demographic and cli...

Supplementary methods. (DOC)

Read codes for colorectal cancer. (DOC)

Frequency of low-dose aspirin use in each study design. (DOC)

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Purpose: We aimed to quantify the extent of over-the-counter (OTC) low-dose aspirin use among patients in The Health Improvement Network (THIN) in the UK. Methods: In September 2013, a random sample of low-dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Primary care practitioners (PCP...

Purpose: To validate the recorded diagnoses of colorectal cancer (CRC) and identify false negatives in The Health Improvement Network (THIN) primary care database. Methods: We conducted a validation study of incident CRC cases in THIN among patients aged 40-89 years from 2000-2011. CRC Read code entries (N = 3805) were verified by manual review...

Purpose:Age-Related Macular Degeneration (AMD) is the most common cause of legal blindness in Western patients over 65 years of age. We aimed to establish the incidence of AMD, and the association of diabetes, cardiovascular and eye diseases with the risk of AMD, in a large cohort of primary care patients in the United Kingdom (UK). Methods:Using d...

BACKGROUND: Proactive, post-authorization monitoring of drug safety and effectiveness is of increasing importance. Rivaroxaban is a Factor Xa inhibitor with multiple indications, including: treatment of venous thromboembolism (VTE) and prevention of recurrent VTE; stroke prevention in atrial fibrillation; and prevention circumof atherothrombotic ev...

The overall vaccine effectiveness of the monovalent rotavirus vaccine in an observational, prospective, multicentre, hospital-based case-control study in Belgium (RotaBel) was 90%. However, rotavirus genotype and co-infecting pathogens are important parameters to take into account when assessing vaccine effectiveness. In this study we specifically...

To evaluate the effectiveness of rotavirus vaccination among young children in Belgium. Prospective case-control study. Random sample of 39 Belgian hospitals, February 2008 to June 2010. 215 children admitted to hospital with rotavirus gastroenteritis confirmed by polymerase chain reaction and 276 age and hospital matched controls. All children wer...

Appendix: Assessment of severity in confirmed cases of rotavirus with 20 point Vesikari scale (sensitivity analysis)

Rotavirus (RV) is the commonest cause of acute gastroenteritis in infants and young children worldwide. A Quality of Life study was conducted in primary care in three European countries as part of a larger epidemiological study (SPRIK) to investigate the impact of paediatric rotavirus gastroenteritis (RVGE) on affected children and their parents. A...

Questionnaire validation. Details of the validation of the questionnaire in DOC format.

This paper reviews the epidemiological data describing meningococcal disease in the Middle East and North Africa (MENA). While meningococcal disease remains an important cause of endemic and epidemic disease in many MENA countries, existing published epidemiological data appear limited, fragmented, and collected via disparate methodologies. Childre...

Meningococcal conjugate vaccines induce herd protection by preventing nasopharyngeal meningococcal acquisition, which is a prerequisite for invasive disease. Thus, meningococcal carriage epidemiology is important in understanding relationships between carriage and disease. A literature search traced information on meningococcal carriage in 27 EU co...

The epidemiology of meningococcal disease in Mozambique and other African countries located outside the "meningitis belt" remains widely unknown. With the event of upcoming vaccines microbiological and epidemiological information is urgently needed. Prospective surveillance for invasive bacterial infections was conducted at the Manhiça District hos...

SUMMARYA literature search traced existing information on meningococcal disease in Asia. Reviewed data describing the epidemiology of meningococcal disease in Asia are incomplete, due in part to absence of surveillance in many countries, poor bacterial detection methods and social and healthcare barriers to disease reporting. This suggests that men...

This observational, prospective study was undertaken to estimate the burden of rotavirus (RV) gastroenteritis (GE) leading to general practitioner (GP)/family paediatrician (FP) visits among children aged <5 years in Czech Republic, Germany, Italy, Poland, Spain and the UK. Children aged <5 years presenting with acute GE provided stool samples for...

Brazil initiated universal immunization of infants with the G1P[8] human rotavirus (RV) vaccine in March 2006. This study evaluated vaccine effectiveness (VE) against severe rotavirus gastroenteritis (RVGE) hospitalizations. Matched case-control study conducted at 4 hospitals in Belém from May 2008 to May 2009. Cases were children hospitalized with...

Between December 2006-May 2007, 371 children aged <3 years attending 15 day care centers (DCCs) in Paris, France were actively followed for acute gastroenteritis [GE; diarrhea (≥3 loose stools/24 hours with or without vomiting) for <14 days] and outbreaks of acute GE (≥3 cases in a DCC with onset within 11 days). Demographic, clinical and cost-rela...

Polysaccharide-protein conjugate vaccines against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae have proven efficacy against radiologically confirmed pneumonia. Measurement of pneumonia incidence provides a platform to estimate of the vaccine-preventable burden. Over 24 months, we conducted surveillance for radiologically confirm...