Las caídas representan una de las principales causas de morbilidad, mortalidad y elevados costes sanitarios a nivel mundial, especialmente en personas de edad avanzada. Se estima que uno de cada tres adultos mayores de 65 años sufre al menos una caída anual, cifra que asciende a uno de cada dos en mayores de 80 años; aproximadamente un 10 % de estas caídas derivan en fracturas, de las cuales cerca de la mitad requieren atención médica.
Paralelamente, la polimedicación y prescripción de psicofármacos en población mayor de 65 años han experimentado un notable incremento en los últimos años, coincidiendo con un aumento de eventos relacionados con caídas y fracturas. Aunque se ha descrito una asociación entre ambos fenómenos, los estudios existentes suelen agrupar los psicofármacos como una única categoría, sin diferenciar el impacto de cada subgrupo específico ni de otros grupos farmacológicos.
Este estudio caso-control doble, basado en datos del mundo real, tiene como objetivo evaluar si el uso de los psicofármacos más prescritos se asocia a un mayor riesgo de caídas —y, en consecuencia, de fracturas—en pacientes de 70 años o más, y determinar si dicho riesgo varía según el tipo de fármaco utilizado.
Se describirán las características sociodemográficas, clínicas y de estilo de vida basales, tanto para la muestra global como estratificadas por presencia o ausencia de caída, utilizando frecuencias absolutas y porcentajes para las variables cualitativas, y medias y desviaciones típicas para las variables cuantitativas.
Los casos y controles se emparejarán mediante puntuaciones de propensión (propensity scores). La asociación entre el diagnóstico de caída y la exposición a fármacos se evaluará mediante razones de Odds (RO), crudas y ajustadas por variables de confusión potenciales, junto con sus intervalos de confianza del 95% (IC95%). Para evaluar la asociación entre fractura y exposición a fármacos, se seleccionarán únicamente los casos. Los casos con fractura se emparejarán con casos sin fractura y, posteriormente, se calcularán las razones de Odds (RO), tanto crudas como ajustadas, junto con sus intervalos de confianza al 95% (IC95%),
para estimar el riesgo de fractura en los individuos expuestos a fármacos en comparación con aquellos no expuestos.

Varilrix and Varivax are authorised for prevention of varicella infection (chickenpox) in adults and children aged 9 – 12 months and older. Both vaccines contain live-attenuated varicella virus (OKA strain) The EMA Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the risk of encephalitis associated with these vaccines following a report of a fatal case in a paediatric recipient of Varilrix (PRAC meeting highlights June 2025). These vaccines are widely used across the EU, and encephalitis is already listed as an adverse reaction in their product information based on rare reports during post-marketing surveillance. At its July 2025 meeting, PRAC recommended updating the product information of Varilrix and Varivax to provide further details on the severity of encephalitis risk (PRAC meeting highlights July 2025). Considering the seriousness of encephalitis and the regulatory context, further investigation is needed. In particular, timely real-world evidence (RWE) is needed to evaluate the association between varicella vaccination and risk of encephalitis in the paediatric population.
Research question and objectives
This study aims to evaluate the association between varicella vaccines (V)/varicella-containing Measles-Mumps-Rubella vaccines (MMRV)/varicella-containing Measles-Rubella vaccines (MVR) and the occurrence of encephalitis in paediatric populations.
Objectives
The specific objectives of this study are:
1.To describe vaccine uptake of V/MMRV/MVR, by vaccine type, brand, dose, country, and age groups, and to describe the characteristics of vaccine recipients.
2.To describe the background rates of encephalitis in the general paediatric population, and to estimate crude incidence rates of encephalitis following varicella infection (chickenpox).
3.To assess the association between V/MMRV/MVR vaccines and varicella infection (chickenpox) with encephalitis among children and adolescents aged 9 months to 18 years. Methods
Study design
Objectives 1 and 2: Population-level descriptive epidemiology and drug utilisation studies (descriptive studies on vaccine uptake, patient characterisations, crude incidence rates of encephalitis after varicella infection (chickenpox), and background rates for encephalitis)
Objective 3: Self-controlled risk intervals (SCRI) analyses
Note: SIDIAP can support the achievement of most of the study’s objectives; however, objectives deemed unfeasible due to data limitations (e.g., vaccines brand) will not be executed.
Population
The study population will include all individuals aged between 9 months and 18 years who are present in the data source during the study period from 1st January 2015 until the latest date of data availability, with at least 365 days of data availability before (reduced to 90 days for children =1 years) index date.
Variables
Exposure:
Primary exposure: varicella vaccines (V) and varicella-containing vaccines (MMRV/MVR). The primary exposure of V will be further categorised into V only, and V+MMR recorded on the same date, as well as by the number of doses received [first or second dose].
Secondary exposures: varicella infection (chickenpox) (overall and severe (defined as requiring hospitalisation) only).
Outcome:
Objective 1: Vaccine uptake and vaccination coverage.
Objective 2 and 3: Encephalitis, defined according to a previous DARWIN EU® study (DARWIN EU® – Background incidence rates of selected vaccine adverse events of special interest (AESIs) ). A 90-day washout period will be used to define incident encephalitis.
Relevant covariates: Age groups, sex, calendar year, season.
Statistical analysis
All analyses will be conducted separately for each data source, and will be carried out in a federated manner, allowing analyses to be run locally without sharing patient-level data. To comply with data privacy regulation, cell counts <5 will be suppressed. Results from all analyses will be presented separately for each data source. Additionally, for SCRI, we will pool the effect estimates for the main analysis (V1) across data sources using random effect meta-analyses, if all data sources have event counts =5 for the respective analyses. We will estimate the vaccine uptake and coverage of children vaccinated in the relevant age group for each vaccine type and dose. Vaccine uptake will be estimated as the absolute number of children and adolescents who received a specified vaccine dose(s) among eligible children. Vaccination coverage will be estimated as the proportion of eligible children who received the specified number of vaccine doses in the relevant age group/at the relevant age milestone. We will report the vaccine uptake and coverage by year. We will then describe the characteristics of vaccine recipients, including age at vaccination, sex, history of other live-attenuated vaccines, and history of encephalitis. Crude incidence rates of encephalitis will also be estimated among a cohort of children and adolescents with a recorded varicella infection (chickenpox) (event rates per 100,000 patient years, with 95% CI), restricted to the first 42 days post diagnosis. Background rates of encephalitis will be estimated for the study period, stratified by age groups. Incidence rate ratios (IRRs) will be estimated using a self-controlled risk intervals (SCRI) design comparing rates of encephalitis in the immediate time after vaccination/varicella infection

Rationale and background
Vasomotor symptoms (VMS), including hot flashes and night sweats, affect up to 80% of menopausal women and significantly impair quality of life. Hormone replacement therapy (HRT) remains the primary treatment for VMS, with various formulations and regimens available depending on clinical factors. Despite its widespread use, there are risks associated with HRT, which vary by age, timing, and treatment type. However, contemporary data on HRT utilisation patterns in Europe are limited, highlighting the need for real-world evidence to inform regulatory decisions.
Research question and objectives
Research question
What are the patterns and trends in hormone replacement therapy (HRT) utilisation among postmenopausal women in European countries over the past three decades?
Objectives
The specific objectives of this study are:
To describe the demographic and clinical characteristics of postmenopausal women, including: age,body mass index (BMI),
smoking status, and: concomitant conditions. HRT type (natural or synthetic) (if feasible). To estimate annual prevalence of HRT use and treatment characteristics among postmenopausal women, overall and stratified by: HRT formulation. route of administration (systemic or local). HRT type (natural or synthetic) (if feasible).
Estimates will additionally be stratified by age group at treatment initiation.
1. To estimate the duration of HRT use among postmenopausal women initiating HRT, overall, and by age group.
2. To describe HRT treatment patterns among postmenopausal women over ten years following HRT initiation, overall, and by age group.
Methods
Study design
A descriptive retrospective cohort study will be conducted using routinely collected health data from 5 data sources from 4 countries across Europe.
Population
The study population will include postmenopausal women defined as i) women aged 50 to 65 years, and ii) women aged <50 years with a prior history of conditions indicating premature or early menopause. This definition will be applied consistently across study objectives. Patient-level characterisation (objective 1): The study population will include postmenopausal women stratified into two cohorts: new HRT users and non-HRT users. Population-level drug utilisation (objective 2): The study population will include all postmenopausal women who meet the criteria defined above during the study period. Patient-level drug utilisation (objectives 3 and 4): The study population will include postmenopausal women initiating HRT during the study period. Variables Exposure: HRT treatment including oestrogen only, progestogen only, oestrogen + progestogen, oestrogen + testosterone, oestrogen + progestogen + testosterone, or other available formulations. Indication: Postmenopausal symptoms/disorders Data source 1. Denmark: Danish Data Health Registries (DK-DHR) 2. Germany: IQVIA Disease Analyzer Germany (IQVIA DA Germany) 3. Spain: Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (BIFAP) 4. Spain: The Information System for Research on Primary Care (SIDIAP) 5. United Kingdom: Clinical Practice Research Datalink GOLD (CPRD GOLD) Statistical analysis Patient-level characterisation (objective 1): Clinical characteristics of interest will be reported as counts and proportions for categorial variables, and as medians with interquartile ranges (IQR) for continuous variables. Population-level drug utilisation (objective 2): Annual prevalence of HRT use will be estimated and expressed as proportion of women using HRT among postmenopausal women. The annual prevalence estimates will also be estimated for HRT formulation (e.g., oestrogen only, progestogen only, oestrogen + progestogen, oestrogen + testosterone, oestrogen + progestogen + testosterone, or other available formulations), route of administration (systemic or local), and HRT type (natural or synthetic) (if feasible). All prevalence estimates will be reported overall and stratified by age group at treatment initiation (<50 years, 50–60 years, and >60 years). Patient-level drug utilisation (objectives 3 and 4): Treatment duration will be estimated and the minimum, q25, median, q75, and maximum will be provided. The treatment pattern will be described based on the sequence of HRT treatment over time. These analyses will be performed overall, and stratified by age group (<50 years, 50–60 years, and >60 years). Potential limiations and considerations Menopausal status is not directly recorded in the database, though it will be inferred based on the age of the women included. Additionally, we do not have information on the type of HRT, such as whether it is natural or synthetic and, therefore, SIDIAP will not contribute to that specific sub-objective, but it will contribute to the rest of study objectives.

Rationale and background
Thromboembolic events are a common complication for individuals with cancer, with risk varying according to the cancer site, suggesting cancer-specific mechanisms playing a role in the occurrence of these events. Haematological malignancies and lung, pancreas, stomach, bowel, and brain cancers are generally associated with a high risk of clot formation, whilst prostate and breast cancers are associated with low risk of thrombosis.
When a safety signal of a thromboembolic event appears in cancer populations, it can be challenging to assess a potential association with the oncologic treatment without reliable information on the background risk. This study is intended to address this knowledge gap by generating evidence on the time to onset of different venous thromboembolic events among adults with selected cancer types.
Research question and objectives
Research question
What was the time to onset of venous thromboembolic events in adults newly diagnosed with each type of selected cancer during the period 2016–2022?
Objectives
The aim of this study is to estimate time to onset of venous thromboembolic events in adults with each type of selected cancer.
The specific objectives of the study are:
1. To estimate the probability of not having thromboembolic events at 6-month intervals within 5 years in adults with each type of selected cancer, overall and stratified by age group, sex, and study subperiod.
2. To estimate median time to onset of venous thromboembolic events in a cohort of adults with thromboembolic events with each type of selected cancer, overall and stratified by age group, sex, and study subperiod.
Methods
Study design
Population-based cohort study. The index date, i.e., date of cohort entry, will be the date of the first cancer diagnosis. Individuals are followed up until the earliest of occurrence of the outcome, loss to follow-up, end of data availability, end of the study period, or death.
Population
The study population will be the population that was included in the study EUPAS1000000440, of which this is a routinely repeated study. This study population will include all individuals aged 18 years and above with a primary diagnosis of one of the selected cancers (bone, brain, breast, colorectal, corpus uteri, kidney, leukaemia and lymphoma, liver, lung, melanoma, oesophageal, ovary, pancreas, prostate, stomach) during the inclusion period (from 01/01/2016 to 31/12/2022). Only individuals with an incident cancer diagnosis (excluding non-melanoma skin cancer), defined as a first cancer diagnosis after =365 days cancer-free history, will be included. Cancer cases and thromboembolic events will be identified based on appropriate computable phenotyping algorithms. Conditions in the OMOP CDM use the Systematised Nomenclature of Medicine (SNOMED) as the standard vocabulary for diagnosis codes. The International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3) will also be considered for cancer diagnoses.
Other eligibility criteria will include at least 365 days of database history prior to index date and at least 365 days between index date and end of data availability in the data source.
Variables
Exposure:
Not applicable.
Outcome:
The outcomes will include thromboembolic events, specifically: deep vein thrombosis (DVT), pulmonary embolism (PE), venous thromboembolism (VTE, composite of DVT and PE), pelvic venous thrombosis (PVT), splanchnic vein thrombosis (SVT, including hepatic and extra-hepatic vein thrombosis), retinal vein thrombosis (RVT, including retinal central vein thrombosis), and disseminated intravascular coagulation (DIC).
Relevant covariates:
The following covariates will be assessed at index date: age group in years (18–34, 35–44, 45–54, 55–64, 65–74, 75–84, and =85), sex, and study subperiod (2016–2019 and 2020–2022). These variables will be used to stratify the results.
Data sources
1. Belgium: IQVIA Longitudinal Patient Database Belgium (IQVIA LPD Belgium)
2. Denmark: Danish Data Health Registries (DK-DHR)
3. Estonia: Estonian Biobank (EBB)
4. Finland: Finnish Care Register for Health Care (FinOMOP-THL)
5. Germany: IQVIA Disease Analyzer Germany (IQVIA DA Germany)
6. Netherlands: Integrated Primary Care Information (IPCI)
7. Spain: The Information System for Research on Primary Care (SIDIAP)
8. United Kingdom: Clinical Practice Research Datalink GOLD (CPRD GOLD) 9. United Kingdom: UK BioBank (UKBB)
Study size
No sample size will be calculated, as this is an exploratory study which will not test a specific hypothesis. Based on the results of the study EUPAS1000000440, the expected number of person counts will be the lowest for DIC (during 1-year follow-up: 5 in FinOMOP-THL – 171 in SIDIAP, with 0 counts in CPRD GOLD, EBB, IPCI, IQVIA DA Germany, and IQVIA LPD Belgium) and highest for VTE (during 1-year follow-up: 27 in IQVIA LPD Belgium – 4,597 in FinOMOP-THL).
Statistical analysis
Analyses will be conducted separately for each data source and carried out in a federated manner, allowing analyses to be run locally without sharing individual-level data.
Objective 1
The probabilities of not having thromboembolic events at 6-month intervals within 5 years in adults with each type of selected cancer will be assessed using the R package CohortSurvival, accounting for a competing risk of death.
Objective 2
The median time to onset of venous thromboembolic events in a cohort of adults with thromboembolic events with each type of selected cancer will be assessed using the R package CohortSurvival.
The R package CohortSurvival is designed to work with data in the OMOP CDM format to extract and summarise survival data applying the Kaplan-Meier method. The analyses will be conducted for the overall cohorts as well as by strata of age group, sex, and study subperiod.
Absence of diagnosis codes will be interpreted as a lack of the conditions themselves. A minimum cell count of 5 will be used when reporting results, with any smaller count reported as “<5” and zero counts as “0”.

L’establiment de xarxes de recerca col·laboratives en atenció primària té el potencial de millorar l’eficàcia, l’eficiència i la naturalesa centrada en el pacient de l’atenció sanitària. El consorci INTRePID, establert el 2020, és una coalició dinàmica d’experts en atenció primària d’Argentina, Austràlia, Brasil, Canadà, Xile, Xina, Japó, Noruega, Perú, Singapur, Suècia, Regne Unit, Togo i els Estats Units. La seva missió compartida és dur a terme recerca comparativa internacional en atenció primària per millorar la comprensió i impulsar un canvi positiu. Els països s’uneixen a INTRePID proporcionant dades agregades, i per tant no personals, sobre visites a l’atenció primària al seu país per a l’anàlisi retrospectiva de dades. Per cada país participant, la població d’estudi inclou totes les persones que reben serveis d’atenció primària des dels 0 fins als 100+ anys i d’ambdós sexes, i s’inclouen totes les dades d’interès des del 2018 fins a les dades més recents disponibles amb actualitzacions anuals. Les variables d’interès consisteixen en el recompte mensual de visites classificat per 1) dades demogràfiques dels pacients, 2) indicadors socioeconòmics, 3) modalitat de l’atenció rebuda, i 4) problemes de salut registrats durant la visita en relació a l’ansietat, la depressió, el trastorn per dèficit d’atenció amb hiperactivitat, l’obesitat i la diabetis. Recerques recents dutes a terme dins del consorci INTRePID han aportat informació valuosa sobre diversos aspectes de l’atenció primària, com per exemple l’adopció variable de l’atenció virtual en resposta a la pandèmia en diferents països o l’impacte de la pandèmia en les consultes de salut mental. Aquestes troballes no només contribueixen al conjunt de coneixements en atenció primària, sinó que també informen les decisions polítiques i les pràctiques sanitàries a tot el món. En unir-se als seus esforços de col·laboració, l’IDIAP Jordi Gol tindrà accés a una gran quantitat de dades i experiència d’investigadors líders en atenció primària de tot el món.

CRIB-MI is a clinical decision support system, integrated through a software tool in the electronic health record system of primary care, that aimed to improve the screening performance on infectious diseases, mental disorders and female genital mutilation in migrants. A pilot cluster controlled randomised trial was conducted in eight primary care centres of Catalonia from March to December of 2018. Four centres had CRIB-MI implemented in the electronic patient record system to support clinicians with the decision to screen migrant patients for the different studied conditions, while health professionals from the other four health centres followed the routine clinical practice. The aim of this study is to investigate the cascade of care from primary to specialist services related to screening, diagnosis, clinical outcomes, referral and vaccination on hepatitis B, among migrants attending the rticipating PCCs.The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards. Findings will be seminated in peer-reviewed journals and communications to congresses.

Abaloparatide is associated with transient increases in heart rate. These transient increases in heart rate were not associated with an increased number of major adverse CV events (MACE) or arrhythmias, neither in the clinical developmental program, nor in the retrospective observational cohort study (BA058-05-028), nor from the five and half years of post-marketing experience in the United States.
The transient increase in heart rate associated with abaloparatide, CV events of MI, stroke and arrhythmia are identified as potential safety risks in the European Union (EU)-Risk Management Plan (RMP) for abaloparatide. Therefore, to further evaluate these potential safety risks for abaloparatide, this EU-based post authorisation safety study (PASS) has been planned as an additional pharmacovigilance activity.
Research question and objectives
Research Question: Is the risk of major cardiovascular events (MACE-1 and MACE-2), arrhythmia, and all-cause mortality (including CV death) associated with abaloparatide use in routine clinical practice in Europe not different relative to teriparatide?
The primary objective of this study is to evaluate the risk of CV events of MACE-1 (defined as events of myocardial infarction (MI), stroke, or CV death), potentially associated with the use of abaloparatide, in comparison with the use of teriparatide in routine clinical practice in Europe.
The secondary objectives of this study are to evaluate the risk of MACE-2 (defined as events of MI, stroke, or all-cause mortality including CV death), MI, stroke, CV death, all-cause mortality including CV death, and arrythmia potentially associated with the use of abaloparatide in comparison with the use of teriparatide in routine clinical practice in Europe
Study design
We will perform a European international network cohort study using data mapped to the Observational
Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The study will use a “new users” design and compare new users of abaloparatide to new users of teriparatide. The index date will be defined as the date on which the patient has a first prescription for either abaloparatide or teriparatide during the data identification period.
MODEL DE SOL·LICITUD
2 IMP-126-CT Versió 08
Study population
The study population comprises all women from the 4 participating databases with osteoporosis (OP) who are prescribed abaloparatide or teriparatide medication for the first time (new user) during the data identification period, have been continuously registered in the data source for at least 12 months prior to the index date, and are at least 50 years of age on the date of the first prescription of abaloparatide or teriparatide.
Variables
The medications of interest include abaloparatide (target therapy) and teriparatide (active comparator).
Primary outcome is MACE-1 (first occurrence of MI, stroke, or death due to CV causes). Secondary outcomes are MI, stroke, death due to CV causes, all-cause mortality, MACE-2 (first occurrence of MI, stroke, or death (all-cause including CV death)), and arrhythmia. Other key covariates and potential confounding factors will be identified at index date based on the patients’ records prior to index date, and will include general patient characteristics, CV risk factors, markers of OP severity, use of other medications, and any other predictors of treatment with abaloparatide as described in detail in the study protocol.
Data sources
This study will be conducted using routinely collected data from different data sources. Data from 4 European countries (France, Spain, Italy, and Germany) will provide heterogeneous and representative data on the safety of abaloparatide in Europe. Data from primary care records (Spain and Italy), outpatient records (Germany), and national claims (France) will be used.
Data Analysis
The data identification period will cover from the second quarter (Q2) of 2024 (when abaloparatide is projected to be launched in the first of the participating countries) until the latest data release available in each of the contributing databases. The IRs of CV events of interest for abaloparatide or teriparatide will be calculated. IR and 95% confidence intervals (CIs) of CV events of interest will be calculated for both study drug users using a Poisson model. The CV event rates for each study drug will also be provided stratified by age groups and key CV risk factors. In addition, large-scale propensity scores (PS) will be estimated using Lasso logistic regression, and the resulting PS will be used to match comparable participants. Then, Cox regression models stratified by matched sets will be used to calculate hazard ratio and 95% confidence interval (CI) for each of the study outcomes according to exposure status.
Post-authorization study: ahttps://www.ema.europa.eu/en/medicines/human/EPAR/eladynos

Aquest protocol correspon a un dels “case studies” que es porten a terme dins del “TARGET EU – ROC19: Comparative effectiveness and safety studies using the target trial emulation (TTE) and estimand frameworks”, SIDIAP 640 (reunió Comitè Científic abril 2025), que tenia com a objectiu estudiar la viabilitat de portar estudis de TTE a diferents bases de dades i seleccionar-ne vàries per portar a terme els estudis proposats. Ens han seleccionat per portar a terme el “CASE STUDY 4: Rivaroxaban and risk of major gastrointestinal bleeding in elderly patients with non-valvular atrial fibrillation” que es descriurà a continuació. L’estudi es farà amb el CDM de ConcePTION i reutilitzarem la instància de 31/12/2024.
Background: Non-valvular Atrial fibrillation (NVAF) is a common arrhythmia that presents a significant morbidity and mortality risk. Current evidence suggests important differences in bleeding risk between DOACs that may be particularly relevant in high-risk population, such as the elderly, who tend to be underrepresented in RCTs. The purpose of this study is to compare the safety of apixaban versus rivaroxaban in older adults with NVAF, with a particular focus on major gastrointestinal bleeding.
Objectives: The primary objective is to estimate the effect of initiating rivaroxaban versus apixaban on time to a first major gastrointestinal bleeding event. Methods: We will conduct an active comparator new-user cohort study using linked electronic health records from Denmark (Danish national registers) and Spain (SIDIAP). Eligible individuals are adults (=75 years) who initiated rivaroxaban or apixaban between 2012 (2014 en cas de SIDIAP) and 2023 (o 2024 segons instància actual, a discutir). In the primary analysis, a while on treatment strategy is used for treatment-related intercurrent events (discontinuation, switching). Inverse probability of treatment weighting (IPTW) is used to adjust for confounding. The primary analysis uses a Cox proportional hazards model, with supplemental analyses using an accelerated failure time model to estimate restricted mean survival time (RMST) at 1 and 2 years. Sensitivity analyses will be conducted to assess the impact of changing the conditions related to non-informative censoring using inverse probability of censoring weights as well as outcome misclassification using probabilistic bias analysis. NO CAL EXTRACCIÓ DE DADES. REUTILITZAREM INSTÀNCIA PRÈVIA DEL CDM DE ConcePTION (no omplim l’apartat de variables de SIDIAP).

Import en USD!!

Rationale and background
Depression, self-harm, suicidal ideation, attempt, and suicide are prevalent health conditions causing significant healthcare utilisation, morbidity, and mortality. Safety concerns on the use of medicines in these populations or as causes of these conditions are common. A better understanding on how well data on these areas are captured will be important to inform the feasibility of conducting RWD studies on these populations or their use as outcomes in DARWIN EU® studies, including the potential validity of phenotypes.
Objectives
1. What is the proportion of individuals with the following types of recording in the DARWIN EU® network: suicide (completed), suicide attempt, suicidal ideation, self-harm, depression, symptom measurement data (PHQ9 depression scales), procedures (psychotherapy and electrotherapy), and depression remission
2. To characterise reporting of suicide, suicide attempt, suicidal ideation, self-harm, and depression within the Darwin EU® network in terms of:
a) Median number (and IQR) of suicides, suicide attempts, suicidal ideation, self-harm, depression, symptom measurement, and resolution reporting per individual within the study period.
b) Rates of suicide, suicide attempt, suicidal ideation, self-harm, and depression, symptom measurement, and resolution reporting within the study period and per calendar year.
c) Explore the values of the symptom measurement data
3. What are the characteristics of individuals with records of suicide, suicide attempt, suicidal ideation, self-harm, and depression in terms of demography, use of concomitant medications (antidepressants, antipsychotics, benzodiazepines, antipsychotics, stimulants, hypnotics), comorbidities (schizophrenia, anxiety disorder, substance use disorder, personality disorders), procedures, and lifestyle factors.
Note: SIDIAP can support the achievement of most of the study’s objectives; however, objectives deemed unfeasible due to data limitations will not be executed (for instance, SIDIAP does not capture cause of mortality)
Methods
Study design
• A population-level descriptive epidemiology study will be conducted to address objectives 1, 2b, and 2c.
• An individual-level characterisation study will be conducted to address objectives 2a and 3.
Population
For objective 1, 2b, and 3c, the study population will include all individuals present in the data source during the study period 01/01/2015 to 31/12/2024 (or to the end of available data) and with at least 365 days of data source history prior to index date. For objective 2a and 3, the study population will include individuals with a first occurrence of suicide (completed), suicide attempt, suicide ideation, self-harm, or depression in the study period with at least 365 days of prior observation.
Variables
Outcome:
Suicide (completed), composite suicide-related events (suicide, suicide attempt, suicide ideation, self-harm), composite fatal suicide-related events, composite non-fatal suicide-related events, suicide attempt, suicidal ideation, self-harm, depression, measurement occurrence of Patient Health Questionnaire-9 (PHQ9) depression scale, healthcare referral and hospital admission, electrotherapy, and psychotherapy.
Relevant covariates:
Demographic characteristics, drug prescriptions (antidepressants, antipsychotics, benzodiazepines, stimulants, hypnotics), conditions (schizophrenia, anxiety disorder, substance use disorder, personality disorders), procedures (psychotherapy, electrotherapy), and observation occurrences (smoking, obesity)
Relevant covariates will be considered at any time prior to the index date.
Statistical analysis
Characteristics will be described by means of pre-specified characterisation. Covariates of interest will be reported as counts and proportions. Yearly incidence rates per 100,000 person-years and period prevalence (proportion) of the outcomes will be estimated in the general population, overall and stratified by age categories and sex. Incidence rates will be given together with 95% Poisson confidence intervals. The statistical analyses will be performed based on OMOP CDM mapped data using IncidencePrevalence and CohortCharacteristics R packages.