Overview of studies
Table 1. All studies that are approved by the IPCI governance board (updated quarterly)
| Nr | Title | Description |
| 2025-04 | The use of asthma medications during pregnancy: A drug utilisation study (DUS) | Asthma medication is essential for managing symptoms and preventing complications, also during pregnancy. Uncontrolled asthma can pose significant risks to both the mother and baby, making consistent use of treatment essential throughout pregnancy. Still, use of medication during pregnancy requires careful consideration of the benefits and potential risks. |
| 2025-03 | Large scale characterization - association between pre-index prescription trends and protopathic bias. | In real life, how these medications are actually used can differ from what doctors recommend. This can happen for various reasons, such as patient concerns about medication safety or differences in prescribing habits among doctors. To better understand these patterns, we are conducting a study on asthma medication use before, during and after pregnancy. This study will provide insights into how asthma medications are prescribed and used in real life. |
| 2025-02 | Temporal trends of mental disorders from 2006 to 2024 using large real-world data | Mental disorders are increasing in the last years, in particular after COVID-19 pandemic, but its prevalence and incidence is still not quantified in particular subgroups of population and comparing different countries. With this study, we want to investigate time trends in the prevalence and incidence of various mental disorders, including anxiety, depression, bipolar disorder, schizophrenia, self-harm, sleep disorders, developmental disorders, substance abuse and eating disorders, using three different indicators: diagnosis, medical prescriptions and sick leaves, among individuals from 0 to 100 years of age using a network of large real-world data from 2006 to 2024. |
| 2025-01 | Non communicable diseases facility-based monitoring guidance with primary care data | Non-communicable diseases (NCDs) are the leading cause of death globally, placing a heavy burden on healthcare systems. Regular monitoring is crucial to track prevalence, assess trends, and evaluate prevention efforts. In 2022, WHO released the Noncommunicable Disease Facility-Based Monitoring Guidance, providing a framework with key indicators for tracking NCD care at the primary level. It covers seven major conditions, including cardiovascular diseases, diabetes, respiratory diseases, and cancers. Countries are encouraged to integrate these indicators into existing health systems to improve monitoring and performance evaluation. Electronic health records (EHRs) can enhance data reliability, and a common data model (CDM) allows standardized analysis across countries. This project aims to harmonize indicators and leverage disaggregated data to reveal healthcare gaps. The use of CDM ensures consistency, reproducibility, and scalability in analysis. Ultimately, this work demonstrates how EHR data mapped to a CDM can support NCD monitoring across Europe using WHO guidelines. |
| 2024-34 | Blood pressure measurement as part of the risk assessment of cardiovascular disease in general practice. | Blood pressure measurement is part of the risk profile for cardiovascular disease in the Netherlands. Various measurement methods are recommended: 1: more than 3 measurements in the general practitioner's practice, 2: 30" measurement, 3: 24-hour measurement. Much is still unclear how the general practitioner applies and should apply this. We have formulated a number of research questions that can be answered with a retrospective research design in IPCI and concern precisely the population in which the general practitioner always makes a risk assessment. 1: Does the risk estimated with the SCORE2 model correspond to the actual risk of CVD during follow-up in the age group of 40-70 years who visit the GP and where the GP measures blood pressure and has determined a risk profile? 2: Is the dip status in a 24-hour measurement a risk factor for developing CVD and is this risk still present when corrected for the SCORE2 risk model? 3: How often do white coat hypertension” and "masked" hypertension occur in the population where the GP does a 24-hour measurement or a 30-minute measurement and what does this mean for the risk of CVD? |
| 2024-33 | Phenotyping and Treatment Patterns in Cluster Headache in Europe: A Multinational, Multidatabase Network Study | The aim of this study is to obtain a better understanding of the characteristics of patients with Cluster headache as well as other headache disorders in a real-world clinical setting. |
| 2024-32 | DARWIN EU® - Suicidality after exposure to finasteride and dutasteride | This study investigates the rates of suicide-related events in adult males using finasteride or dutasteride for androgenetic alopecia (hair loss) or benign prostatic hyperplasia (BPH). Finasteride and dutasteride are 5α-reductase inhibitors that reduce testosterone conversion to dihydrotestosterone and are commonly prescribed in Europe for these conditions. While mood changes, including depression and suicidal ideation, have been reported with finasteride, data on suicide-related events among users remain sparse. This study aims to establish the background incidence of such events in the general male population and in males newly diagnosed with androgenetic alopecia or BPH, with sub-analysis based on treatments. It will use a population-level cohort design, drawing from multiple European health databases. Outcomes measured include completed and attempted suicide, suicide ideation, intentional self-harm, and composite suicide events. Incidence rates will be calculated per 100,000 person-years and stratified by age and treatment type. The study seeks to provide insights into the psychiatric risks associated with these drugs, supporting future regulatory decisions and risk/benefit evaluations. |
| 2024-31 | DARWIN EU® - Drug utilisation of salbutamol products for inhalation and therapeutic alternative inhalation products | This research explores the real-world usage of inhaled salbutamol, a critical medication for managing asthma and COPD, amid rising demand in Europe due to aging populations and deteriorating air quality. The study aims to assess whether salbutamol use has increased in recent years, raising concerns about potential shortages. Additionally, it seeks to understand the impact of such shortages on alternative inhalation therapies. Through a population-level cohort study, monthly and yearly prescribing rates of inhaled salbutamol and alternative medications will be analyzed across seven European healthcare databases from 2015 onward. The research will describe prescription rates by drug type, healthcare setting, and patient demographics (predefined age groups and sex). Patient-level analyses will assess salbutamol use by formulation and indication, focusing on users' characteristics. The study's findings will support preparedness efforts to manage potential shortages, offering insights into patterns of salbutamol use and highlighting implications for alternative therapies in real-world settings. |
| 2024-30 | Determinants of a missed diagnosis of appendicitis and preventable referrals of children with acute abdominal pain in primary care | Acute appendicitis is the most common surgical emergency in children, yet its diagnosis can be challenging for the general practitioner due to overlap in clinical presentation with self-limiting diseases or atypical symptoms. Previous research demonstrated that approximately 70% of referred children with acute abdominal pain do not have appendicitis, and 19% of children with appendicitis are missed during first consultation. Therefore, the aim of this study is to identify demographic and clinical determinants of a missed diagnosis of appendicitis and preventable referrals of children with acute abdominal pain in primary care. Knowledge about the influence of such factors could help improve the diagnostic process in these children. |
| 2024-29 | The influence of allopurinol on cardiovascular disease in patients with gout | Gout is the most common inflammatory arthritis, affecting 1.7% of the total Dutch general practice population, and 3-4% of the adult population. Acute gout is one of the most painful forms of arthritis and is characterized by the abrupt onset of severe joint pain, swelling, and erythema. The management of a gout attack consists of non-steroidal anti-inflammatory drugs (NSAIDs), oral corticosteroids or colchicine. When patients experience three or more gout attacks in a year the GP guideline advices to start treatment with uric acid lowering treatment, being allopurinol as firstly recommended drug. Until now evidence is conflicting whether treatment with urate lowering therapy reduces cardiovascular risk in patients with gout The aim of the current study is to evaluate whether the use of allopurinol influences the risk of new cardiovascular diseases in patients with gout with no prior cardiovascular diseases. |
| 2024-28 | DARWIN EU® - Characterisation of exposure to acitretin and purpura and related conditions | The Marketing Authorisation Holders (MAHs) that hold Marketing Authorisations (MAs) for acitretin in Canada and the US have included purpura in their label. The Pharmacovigilance Risk Assessment Committee (PRAC) requested additional real-world evidence (RWE) to assess the causal association between certain purpura and related conditions and acitretin before deciding whether to include selected purpura and related conditions in section 4.4 (or 4.8) of the Summary of product characteristics (SmPC) of acitretin. Acitretin (D05BB02) is a synthetic aromatic analogue of retinoic acid. Retinol (a derivative of Vitamin A) is known to be essential for normal epithelial growth and differentiation. Acitretin is a Nationally Authorised Product (NAP) with approved indications including severe forms of psoriasis (erythrodermic psoriasis and local or generalized pustular psoriasis); severe disorders of keratinization (such as congenital ichthyosis, pityriasis rubra pilaris, and Darier’s disease), and other disorders of keratinization which may be resistant to other therapies. It is authorised in the majority of European Union (EU) countries (not in Bulgaria, Cyprus, Greece, Malta, Romania). This study aims to characterise patients treated with acitretin, estimate the incidence rate of purpura and related conditions in patients with treatment indications for acitretin. |
| 2024-26 | DARWIN EU® - Incidence rates of venous thromboembolic events in cancer patients | Study aims to estimate incidence rates of venous thromboembolic events (deep vein thrombosis, pulmonary embolisms, venous thromboembolism, composite of deep vein thrombosis and pulmonary embolisms, pelvic venous thrombosis, splanchic vein thrombosis, including hepatic and extra-hepatic vein thrombosis, retinal vein thrombosis, including retinal central vein thrombosis, and disseminated intravascular coagulation in adult patients (aged 18 and above) newly diagnosed with selected cancers (lung, breast, ovary, corpus uteri, prostate, pancreas, colorectal, stomach, oesophageal, liver, brain, bone, kidney, melanoma, lymphoma and leukaemia) and to describe their characteristics at the time of cancer diagnosis. |
| 2024-25 | DARWIN EU® - Antipsychotic prescribing in people with dementia in Europe: a descriptive analysis of trends and patient characteristics | Antipsychotic drugs have been associated with several adverse drug reactions, particularly in the elderly. Somnolence, hypotension, extrapyramidal side effects and gait abnormalities are well-recognized side effects that may in turn contribute to the risk of falls and fracture in elderly persons. Similarly, cardiovascular adverse effects, falls and injuries may increase mortality. Antipsychotic drugs are indicated for the management of schizophrenia and bipolar disorder. Antipsychotics are also used to manage behavioral and psychological symptoms of dementia (BPSD) and recommendations over their use suggest they should be discontinued after BPSD symptoms resolve. Safety concerns have previously led to regulatory warnings and risk communications over their use. Antipsychotic drugs can be classified into typical and atypical antipsychotics with different recommendations for their use. For example, guidelines recommend the preferential use of atypical antipsychotics when required for the management of BPSD. |
| 2024-24 | DARWIN EU® - Antipsychotic prescribing in Europe: a descriptive analysis of trends and patient characteristics | Antipsychotic drugs have been associated with several adverse drug reactions, particularly in the elderly. Somnolence, hypotension, extrapyramidal side effects and gait abnormalities are well-recognized side effects that may in turn contribute to the risk of falls and fracture in elderly persons. Similarly, cardiovascular adverse effects, falls and injuries may increase mortality. Antipsychotic drugs are indicated for the management of schizophrenia and bipolar disorder. Antipsychotics are also used to manage behavioral and psychological symptoms of dementia (BPSD) and recommendations over their use suggest they should be discontinued after BPSD symptoms resolve. Safety concerns have previously led to regulatory warnings and risk communications over their use. |
| 2024-23 | DARWIN EU® - Azathioprine - user characteristics | Azathioprine is a purine analogue and prodrug of mercaptopurine that is used as an immunosuppressive medication alone or in combination with other immunosuppressive therapy to prevent rejection following organ transplantation and to treat certain autoimmune diseases, where it is considered a steroid-sparing agent. The PRAC recently discussed a signal procedure regarding the association between treatment with azathioprine and non-cirrhotic portal hypertension/porto-sinusoidal vascular disease (PSVD). |
| 2024-22 | Patterns of hand osteoarthritis management in general practice | Hand osteoarthritis (OA) is more prevalent than hip OA and almost as frequently occurring as knee OA as far as we know from literature. Knee and hip OA can be coded with an ICPC code in the electronic health records (EHR) of general practitioners (GPs), but there is no code for hand OA. In ongoing research we developed an algorithm for hand osteoarthritis, and we will estimate the incidence and prevalence of hand OA (Title: Incidence and prevalence of hand osteoarthritis and associations with comorbidities). The aim of this additional project is to study the patterns of hand osteoarthritis management of general practitioners using routine healthcare data. |
| 2024-21 | DARWIN EU ® Characterising the use of JAK inhibitors in Europe: a Drug Utilisation Study | JAKi therapy has been gaining popularity for the treatment of several autoimmune conditions, including rheumatoid arthritis, inflammatory bowel disease, and atopic dermatitis. The first JAKi, tofacitinib, was approved by the European Medicines Agency (EMA) for the management of rheumatoid arthritis in 2017. An FDA-requested study (the Oral Rheumatoid Arthritics Trial (ORAL) Surveillance trial) showed a higher risk of major adverse cardiovascular events (MACE), cancer and adjudicated opportunistic infection with tofacitinib compared to tumour necrosis factor (TNF) inhibitors in patients aged 50 years or older with at least one cardiovascular risk factor. Further research has been conducted on the safety profile of JAKi for other indications, including psoriatic arthritis, ulcerative colitis and atopic dermatitis. It was shown that risk of venous thrombotic events of JAKi users was similar to placebo users in patients with atopic dermatitis and ulcerative colitis. Incidence of adverse events, including herpes zoster infection and thrombotic events, remained similar with longer follow-up up to two years in psoriatic arthritis patients with JAKi. However, especially in these newer indications, the available evidence has been limited by short duration of follow-up and limited sample size. The current study aims to identify the incidence of new JAKi use over time, and to characterise new users of JAKi in Europe to inform the feasibility of future safety studies. |
| 2024-20 | DARWIN EU® - Incidence of suicidality in patients with specific chronic skin conditions | Chronic skin conditions like acne and psoriasis cause significant physical and psychological distress, leading to social stigmatization and an increased risk of mental health issues, including depression and anxiety. Concerns about their link to suicidality-related events are rising. There have been signals of suicidal ideation associated with treatments for acne and other skin disorders, but estimating the extent of confounding by indication is difficult. There is insufficient data on the background rates of suicidality in these populations, as most studies focus on broader mental health outcomes. This study aims to evaluate suicide-related drug safety signals for acne and psoriasis treatments by understanding the background rate of suicidality in these patients compared to the general population. The research will focus on the incidence rates of suicidality-related events in patients with acne and psoriasis, stratified by sex, age categories (12-<18 years, 18-30, 31-40, 41-50 etc, >=81 years), calendar year, and mental health history. The study will be a population-level cohort study using data from multiple European databases from 2010 to 2023. Outcomes of interest include completed and attempted suicide, suicidal ideation, intentional self-harm, and a composite endpoint encompassing all these outcomes with analyses stratified by various factors and reported with 95% Poisson confidence intervals. This research will provide clearer insights into the risks of suicidality in patients with chronic skin conditions and inform the assessment of treatment safety. |
| 2024-19 | DARWIN EU® - Suicidality following exposure to doxycycline | There have been reports on a potential association between use of doxycycline and suicide. By means of a self-controlled case series and an active comparator study, the study aims to assess the association between use of doxycycline and specific outcomes of interest (i.e. suicidality events). Research questions 1. Is there a causal association between the use of doxycycline and suicide-related events? 2. Does the association between doxycycline use and completed suicide and suicide-related events vary by indication of use, compared to active comparators? |
| 2024-18 | DARWIN EU® - Drug Utilisation Studies on GLP-1 Agonists | The study addresses the shortage of GLP-1 receptor agonists (GLP-1 RA) affecting EU Member States since 2022, expected to persist through 2024. These medications, crucial for treating diabetes and managing weight, have seen increased demand, exacerbated by off-label use for weight management. This study aims to provide a comprehensive overview of the characteristics of patients prescribed GLP-1 RA medications over the past decade, helping to identify the determinants driving demand and contributing to shortages. The study will also compare trends in the prescription of other weight loss medications to understand the broader context. The research involves a population-level cohort study to assess the incidence and prevalence of GLP-1 RA prescriptions, alongside a patient-level cohort study to characterize new users of these medications, particularly differentiating between those with diabetes, obesity, or both. The data for this study will be sourced from five databases across Belgium, Germany, the Netherlands, Spain, and the UK, ensuring a broad and representative sample. Key variables will include age, sex, body mass index, initial and cumulative doses, and comorbidities, providing a detailed picture of prescribing patterns and patient demographics. Statistical methods will include incidence and prevalence calculations, stratified by various factors such as age, sex, and specific indications. The analysis will utilize the OMOP Common Data Model to harmonize data across different sources, ensuring consistency and comparability. The study's findings will be disseminated through an interactive dashboard and a detailed report, offering valuable insights for policymakers, healthcare providers, and regulatory bodies to address medication shortages and optimize patient care. |
| 2024-16 | DARWIN EU® - Background incidence rates of selected vaccine adverse events of special interest (AESIs) in Europe | The study aims to estimate the background incidence rates of selected vaccine AESIs and understand the demographic and clinical characteristics of patients in Europe from 2010 to the most recent data available. This retrospective, multi-database cohort study utilizes electronic health records from the UK, the Netherlands, Spain, Norway, and Germany ensuring comprehensive coverage across different healthcare settings and regions in Europe. The study seeks to support vaccine safety monitoring through detailed observed-to-expected analyses, which are crucial for timely regulatory responses to vaccine safety concerns and maintaining public confidence in vaccination programs. Objective 1 will be conducted in two stages. Firstly, we will develop the phenotypes for the study outcomes following the Standard Operating Procedure under a dynamic workflow between the study team and the EMA. Then, incidence rates per 100,000 person-years and corresponding 95% confidence intervals will be reported using exact Poisson model. Analysis will be stratified by calendar month, year, age group and sex within each database. Incidence rates will not be estimated if there are less than 5 events in a given stratum. In analysis of Objective 2: Population-level characteristics, we will use the large-scale characterisation to describe the characteristics of the general population overall and for each calendar year. For each incident AESI cohort, we will summarize the demographics and clinical characteristics of individuals with incident outcomes using the large-scale characterisation. We will construct an age-sex matched cohort from the general population for each AESI cohort to contextualize the characteristics of the incident AESI cohort using standardised mean difference (SMD). |
| 2024-15 | DARWIN EU® – Trends in utilisation of Attention-Deficit Hyperactivity Disorder (ADHD) Medications | The study aims to characterize the use of ADHD medications from 2010 to 2023 across several European countries. This investigation is crucial due to the increased demand for these medications, coupled with production constraints and regulatory changes, which have led to monitoring by the Medicines Shortages SPOC Working Party. The study focuses on five main ADHD medications: lisdexamfetamine, methylphenidate, atomoxetine, dexamphetamine, and guanfacine, assessing their prevalence, incidence, and various patient-level metrics such as initial dose, cumulative dose, and treatment pathways. The research employs a population-level drug utilization study for general prevalence and incidence rates and a patient-level new user cohort study to delve deeper into specific metrics such as treatment duration and pathways. Data will be sourced from six databases in Belgium, Germany, the Netherlands, Spain, and the UK, all mapped to the OMOP Common Data Model for consistency and comparability. The study includes all individuals aged three years and older with at least a year of prior data, ensuring comprehensive coverage and reliable trends analysis. The primary outcomes will be the prevalence and incidence rates of ADHD medication use, along with detailed treatment patterns among new users. The results of study can provide valuable insights into ADHD medication trends, helping anticipate potential shortages and informing appropriate patient management strategies across Europe. The results will be disseminated to the European Medicines Agency (EMA) and made available through interactive dashboards, ensuring wide accessibility and utility for policymakers and healthcare providers. |
| 2024-14 | DARWIN EU® - Drug utilisation study on medicinal use of cannabis flos | Cannabis flos (dried, whole or fragmented, flowering tops of Cannabis sativa L.) is not registered as medicinal product in the European Union (EU). However, there are different regulatory strategies among EU member states that enable some specific exemptions for its use and its supply by pharmacies, as a controlled substance under physician’s prescription only. Scientific data is needed to inform and support regulatory work including a possible establishment of an EU herbal monograph. The aims of this study are: 1. To estimate incidence rates and prevalence of use of Cannabis flos, overall and stratified by age, sex and country/database, during the study period from 2014 to 2023. 2. To characterise the cohort of patients being treated with the Cannabis flos at the time of new prescription/dispensation of the selected medicinal products in terms of demographics, indication for prescribing/dispensing, comorbidities and comedication. Additionally, to determine duration of treatment with Cannabis flos products and optionally, to describe the route of administration. Results will be stratified by pre-specified medicinal product of interest and database. |
| 2024-13 | Incidence and prevalence of hand osteoarthritis and associations with comorbidities | Hand osteoarthritis (OA) is more prevalent than hip OA and almost as frequently occurring as knee OA as far as we know from literature. Knee and hip OA can be coded with an ICPC code in the electronic health records (EHR) of general practitioners (GPs), but there is no code for hand OA. We do not know how many people consult the GP with hand OA and what kind of treatment the GP gives. This project is part of a larger project that investigated the effectiveness of primary care treatment and implementation strategies for the best treatment options for people with hand OA. Knowledge about prevalence and incidence of hand OA, associations with comorbidities and knowledge about currently used treatment in primary care is the starting point in this project. |
| 2024-12 | Levothyroxine use in the Netherlands: time of initiation and risks of treatment. | At what TSH level should levothyroxine (L T4) be started? According to the Dutch General Practitioners' Guideline (NHG), two consecutive TSH values >6.0 recommend a trial treatment with L T4, which should be discontinued after several months if there is no improvement in symptoms. This could lead to heterogeneity in the initiation of treatment between GPs. Studies from other countries show an increase in the number of prescriptions for LT4 over the years and a decreasing trend in the TSH levels at which levothyroxine is started, even down to normal TSH levels. However, it is not known whether these worrying findings also apply to the Netherlands. Endogenous hyper- and hypothyroidism are associated with an increased risk of complications (atrial fibrillation, coronary heart disease, heart failure and CVA, osteoporosis and possibly dementia). However, there are few data on the risk of these complications with exogenous LT4 overtreatment. |
| 2024-11 | Personalized Treatment Strategies for Hypertension: Use of Causal Inference and Machine Learning | Current hypertension control guidelines take a “one-size-fits-all” approach to pharmaco-treatment, for both starting medication and adding medication classes when first-line agents fail to control BP. This is a major limitation as prior research has discovered some heterogenous treatment effects (HTE) in certain BP medications. With HTE of antihypertensive medications identified, personalized BP treatment strategies can be developed to recommend the most effective medication classes depending on the patient type. Randomized controlled trials (RCT) are the gold standard for evaluating treatment effects, but the sample size required to compare the number of first-line medications classes for hypertension makes RCT infeasible. Alternatively, observational data offers sufficient samples, but issues of confounding renders traditional statistical analysis biased. Our study proposes to bring together modern research informatics and statistical analysis to overcome these challenges. We plan on using state-of the-art causal inference techniques to alleviate concerns about confounding by indication and selection 22-05-2024 11/2024 bias in observational data. We will identify and validate optimal personalized treatment for hypertension through determining HTE of first-line antihypertensive medications in terms of reduced BP. Our study is positioned to generate urgently needed evidence in the space of hypertension treatment and has the potential to make a direct impact in clinical practice, benefiting patients who struggle with BP control. |
| 2024-10 | Studying Drug shortages in Europe: A Multinational, Multidatabase Network Study | This study aims to characterise the incidence and prevalence of medicines with (suggested) shortages and their alternatives for the period 2015-2023, stratified by healthcare setting and quarterly period in each database. Furthermore, the researchers aim to describe the patients receiving a new prescription / dispensation of a medicine with (suggested) shortages for the period 2015-2023, stratified by year in each database, including information on potential indication, treatment duration, and dosage. This study is executed on multiple European databases in the European Health Data and Evidence Network (EHDEN) project (www.ehden.eu). |
| 2024-09 | Musculoskeletal complaints in Dutch general practice | Varying percentages are reported in the literature for the share of consultations for musculoskeletal disorders in general practice, ranging from 13 to 29%. These numbers are mainly based on data from the UK and Sweden. It is assumed that these numbers are representative of Dutch general practice, but scientific publications with exact numbers are lacking. The current project will answer the following questions: 1) What is the share of consultations for musculoskeletal disorders in Dutch general practice? 2) For which musculoskeletal disorders is most consulted in Dutch general practice? 3) What are the demographic characteristics (age/gender) of patients who consult for musculoskeletal disorders in Dutch general practice? |
| 2024-08 | DARWIN EU® – Frailty and polypharmacy among adults with selected cancers at diagnosis. | Frailty, polypharmacy, and comorbidities are common and important factors which usually coexist in older patients. Assessment of frailty and polypharmacy is difficult due to the lack of standardised definitions. However, accounting for them is relevant, especially among older adults with cancer, due to their adverse impact on cancer outcomes and treatment. Despite this, studies reporting on the prevalence of frailty and polypharmacy, specifically in older adults with cancer, remain sparse. This study intends to investigate the ability to characterise frailty and polypharmacy in real-world data sources, to estimate the prevalence of frailty and polypharmacy in people aged 18 and above with selected cancers at the point of diagnosis and to describe their characteristics. While the focus is on older adults, the study will explore the full age range of adulthood to better contextualise the results. |
| 2024-07 | DARWIN EU® – Comparing direct and indirect methods to estimate prevalence of chronic diseases using real-world data | Prevalence of a disease can be estimated directly, as the proportion of individuals in a population affected by a condition at a given point in time. For disease with low prevalence, stable incidence over time and stable disease duration over time, it can also be estimated indirectly, as product of incidence rate and median disease duration. In this study the researchers will compare direct and indirect estimated prevalence of some rare, chronic diseases (Cystic fibrosis, Haemophilia, Pulmonary arterial hypertension, Pancreatic cancer, Sickle cell disease). For each of these diseases they will estimate point prevalence (direct estimation), incidence rate and median disease duration. This will be done using all individuals with disease diagnosis and when distinguishing individuals with diagnosis at paediatric age and individuals with diagnosis at adult age. The calculated indirect prevalence will be compared with the direct estimated prevalence. |
| 2024-06 | Champion HMB-2: Characterization and treatment pathways of heavy menstrual bleeding (HMB) | Heavy menstrual bleeding (HMB) affects approximately 30% of women of reproductive age and can have a profound negative impact on many aspects of a woman’s quality of life, including energy levels, mood, work productivity, social interactions, family life, and sexual functioning. However, a significant proportion of women with HMB symptoms do not seek medical help, as many do not perceive heavy menstruation as a problem. Both pharmaceutical and surgical interventions are currently used in the treatment of HMB, although real-world evidence on treatment pathways is lacking. The study aims to identify women of reproductive age diagnosed with HMB in respective data sources to generate evidence on these patients’ baseline characteristics and longitudinal treatment pathways across countries with different health care systems. This study is executed on multiple European databases in the European Health Data and Evidence Network (EHDEN) project (www.ehden.eu). |
| 2024-05 | Evaluation of Adverse Effects of SGLT2 Inhibitors in Elderly Patients with Heart Failure and Diabetes Mellitus: A retrospective analysis of frequency and type of adverse events | This study investigates side effects of SGLT2 inhibitors in older patients with heart failure and diabetes versus younger adults. It aims to assess urinary tract infections, genital fungal infections, dizziness, hypotension, dehydration, falls, kidney issues, hypoglycemia, ketoacidosis, and other potential side effects. |
| 2024-04 | SPIDeRR((Stratification of Patients using advanced Integrative modeling of Data Routinely acquired for diagnosing Rheumatic complaintS) | MSK complaints are the most common complaints in Dutch general practice. Patients' journey from symptoms to diagnosis to successful treatment is often arduous, long and frustrating. In this regard, our health care system is not yet equipped to implement early and preventive treatments, because diseases are often recognized too late. With this project, the researchers want to investigate the trajectory of patients with musculoskeletal disorders at an early stage, in particular for rheumatic diseases, such as rheumatoid arthritis, axial spondyloarthritis, osteoarthritis and gout. |
| 2024-03 | Distinguishing tumor location and treatment of patients with breast cancer in the Dutch general practice data using text mining | A group of Dutch databases are mapping their data to the OMOP Common Data Model (https://www.ohdsi-europe.org/index.php/national-nodes/netherlands). As part of this OHDSI NL collaboration, a number of oncology hospitals and IKNL have mapped breast cancer patient data to the OMOP common data model with the intention to perform studies together. Their objective is to investigate the differences in characterization (demographics, comorbidities, treatments) of patients with breast cancer at several institutions in the Netherlands. This characterization aims to look at left and right breast cancer patients (female and male) patients as well as whether there are associations between tumor location, treatment, and the development of further disease. In addition, there is interest investigating prediction questions, such as prediction of survival and prediction of diagnosis. The Department of Medical Informatics would like to join this initiative with the IPCI data. To take part in this research, however, we want to first ensure that we can retrieve detailed information regarding the location of the breast cancer tumor and subsequent treatment. Given the lack of granularity that is commonly associated with ICPC codes and the IPCI database, we propose to first perform an investigation into whether we can distinguish the tumor location and treatment using the structured data. If this is deemed to be insufficiently granular then the next step will be to implement the recently developed and tested natural language processing techniques. Previous research showed it is possible to use rule-based methods to differentiate the sidedness of injury or disease effectively and efficiently in the IPCI database. We will evaluate the performance of the text mining approach by manually validating a random sample of cases. |
| 2024-02 | DARWIN EU®- Effectiveness of COVID-19 vaccines on severe COVID-19 and post-acute outcomes of SARS-CoV-2 infection | The Vaccine Monitoring Platform, jointly coordinated by EMA and ECDC, focuses on continuous assessment of COVID-19 vaccine effectiveness. Recent studies in Nordic countries show a bivalent mRNA booster provides 67.8% protection against COVID-19-related hospitalization. Waning effectiveness and impacts on new variants, including XBB, are of regulatory concern. impacts on new variants, including XBB, are of regulatory concern. Post-acute outcomes of SARS-CoV-2 infection, such as cardiovascular events and new-onset diabetes, require investigation. This study aims to generate evidence on COVID-19 vaccine effectiveness in preventing severe COVID-19 outcomes and post-acute conditions. |
| 2024-01 | DARWIN EU® - Characterization of patients with chronic hepatitis B and C | The European Centre for Disease Prevention and Control (ECDC) has developed a monitoring system for Hepatitis B Viral Infection (HBV) and Hepatitis C Viral Infection (HCV) aligned with indicators and targets of the GHSS and the WHO European Region Action Plan Comprehensive data on the prevalence of chronic HBV/HCV infections and utilisation of antiviral treatments for chronic HBV/HCV infections are important to monitor progress towards the elimination targets related to treatment, to adjust prevalence estimates over time, and to support effective planning of prevention and control activities by countries. To date, data collected by EU Member States and reported to ECDC come from a range of heterogeneous sources with different levels of quality and completeness. Several reasons contribute to this heterogeneous data collection including as the lack of standardised or electronic data systems in countries. Therefore, robust and timely data at national or subnational level generated through DARWIN EU will add to the available body of evidence and/or will help address current evidence gaps. The aims of this study are: 1.To report the number and percentage of patients diagnosed with chronic HBV/HCV infection who initiate treatment with interferon or any specified antivirals, stratified by age, sex, calendar year, and country/database throughout the study period (2012 - 2022). 2. To report the number and percentage of patients diagnosed with chronic HBV/HCV infection who are undergoing treatment with any specified antivirals, stratified by age, sex, calendar year, and country/database during the study period (2012 - 2022). 3. To characterize patients with chronic HBV/HCV infection at the initiation of treatment with interferon or specified antivirals, stratified by age, sex, calendar year, and country/database during the study period (2012 - 2022). 4. To estimate the proportion of all patients with chronic HBV/HCV infection, stratified by age, sex, calendar year, and country/database during the study period (2012 - 2022). |
| 2023-19 | Characterising alopecia areata | Alopecia areata (AA) is a complex autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body. AA can have a significant negative impact on health-related quality of life and there are limited options for effective management of AA. Until recently, there was no approved treatment. In this study, we will describe the baseline demographics and clinical characteristics of patients newly diagnosed with alopecia areata 2015-2022 and the treatments of interest among individuals post-diagnosis. |
| 2023-18 | DARWIN EU – EHDS Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 in the context of the OMICRON variant | Coronavirus disease-2019 (COVID-19) patients are at increased risk of venous and arterial thromboembolic events. SARS-CoV-2 variants have evolved during the COVID-19 pandemic with the dominant variant being Omicron now (as of December 2021). Information relating to thromboembolic risk and its impact on COVID-19 largely relates to COVID-19 variants occurring earlier during the pandemic. There is a need to better understand the risks of thromboembolic events among patients with COVID-19 associated with the Omicron variant, their impact on prognosis, and whether risk factors for such events remain the same, overall and in the context of prior COVID-19 infection, SARS-CoV-2 vaccination and among certain subgroups. The study aims to (a) estimate the background incidence rate of venous and arterial thromboembolic events among the general population pre-pandemic population. (b) estimate the incidence rate of venous and arterial thromboembolic events among patients with COVID-19 within 30-, 60-, 90- and 180-days during the Omicron period, stratified by prior SARS-CoV-2 vaccination and prior infection status, (c) estimate the incidence rate of venous and arterial thromboembolic events among patients with SARS-CoV-2 vaccination within 30-, 60-, 90- and 180-days, stratified by prior infection status, (d) estimate the association between clinical risk factors and prior SARS-CoV-2 vaccination on the incidence rate of venous and arterial events among people with COVID-19, and (e) estimate incidence rate ratios for venous and arterial thromboembolic events among patients with COVID-19 and different SARS-CoV-2 vaccine doses compared to the background population. |
| 2023-17 | Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis | Gastroparesis is a medical condition characterized by delayed gastric emptying, causing symptoms like postprandial fullness, nausea, vomiting, and upper abdominal pain. Pharmacotherapy, particularly medication with prokinetic properties, has been used to manage symptoms, which includes off-label use. This study aims to (a) describe the characteristics of children and adults prescribed medications with prokinetic properties, (b) determine the dose, formulation, cumulative duration and setting (inpatient vs outpatient) at time of treatment initiation of any of the prokinetic drugs, and (c) determine the incidence and prevalence of use of medications with prokinetics properties in both the pediatric and adult population diagnosed with gastroparesis. |
| 2023-16 | Drug utilization study in patients with major depressive disorder | In clinical trials involving patients with major depressive disorder, participants who start treatment may experience intercurrent events (IEs) during follow-up, such as treatment discontinuation, switch to alternative therapies, or changes in background/concomitant therapies (e.g., sleep aids). To gain a more comprehensive understanding of the external validity of clinical trials in this indication, it is essential to assess whether the rate of occurrence of these IEs is similar in real-life settings compared to what is observed in the clinical trials. This study aims to (a) examine the proportion of patients with newly diagnosed major depressive disorder who start treatment with antidepressants (NSRls, SSRls, or other anti-depressants), (b) To estimate the duration of antidepressant use in patients with newly diagnosed major depressive disorder who initiate treatment with antidepressants (NSRls, SSRls, or other antidepressants), and (c) assess the proportions of patients with newly diagnosed major depressive disorder who initiate, switch, or discontinue treatment with psycholeptics (antipsychotics, anxiolytics, hypnotics, and sedatives). |
| 2023-15 | Elbow complaints in children | Elbow complaints in children can be a source of concern and discomfort, with far-reaching complications resulting from a delayed diagnosis. Many children will first be seen in a GP practice and receive their first treatment there. The research questions in this study are (a) what is the incidence of elbow complaints in primary care, (b) what diagnosis is made, and (c) which patients are referred to the specialist. |
| 2023-14 | Adherence to the NHG guidelines for the diagnosis of hypertension in general practice | The diagnosis of hypertension must be based on multiple doctor’s office measurements on several days, multiple measurements at home, a 30-minute method or an outpatient 24-hour measurement. Diagnoses made on a one-off measurement can lead to over- and under-treatment. There are indications that the diagnosis is not always made according to the guidelines. The research questions are: (a) to what extent are the criteria for diagnosing hypertension in primary care met, (b) has the introduction of the CVRM (CVRM standard from 2012) influenced the diagnosis of hypertension and (c) does socio-economic status influence the quality of hypertension diagnosis? |
| 2023-13 | DARWIN EU - Drug utilization study of prescription opioids | Recently, concerns have been growing in Europe due to increasing opioid use and related mortality. Factors such as chronic pain, mental health disorders, and advanced age can exacerbate misuse and the development of dependence. This multi-national study aims to (a) investigate the annual incidence and annual period prevalence of use of opioids (overall, active drug substance, strength (weak/strong opioids) and route (oral, transdermal or parenteral)), stratified by calendar year, age, sex and country/database during the study period 2012-2022, and (b) to determine duration of prescription opioid use, as well as characteristics of new users and indication for opioid prescribing/dispensing, all stratified by country/database. |
| 2023-12 | Familial hypercholesterolemia: an overview of the current detection and management among general practitioners affiliated to the IPCI database | Familial hypercholesterolemia (FH) is the most common monogenetic cause of premature coronary artery disease (CAD). FH is characterized by a lifelong elevation of LDL cholesterol (LDL-C), which increases the risk of atherosclerotic cardiovascular disease (ASCVD) in patients with familial hypercholesterolemia up to 25 times higher than in individuals with normal LDL-C. degree. Recent systematic reviews and meta-analyses show a prevalence of approximately 1:300 in the general population, with a 20-fold higher prevalence in people with CAD and a 23-fold higher prevalence in people with severe hypercholesterolemia. Roughly 57% of the FH population has now been detected in the Netherlands. The aim of this study is to provide an overview of the current detection and treatment of FH patients in primary care in order to achieve better FH diagnosis and early treatment and thus reduce the risk of developing cardiovascular disease at a young age. |
| 2023-11 | Impact of the COVID-19 pandemic on mental health diagnoses and prescriptions | The aim of this project is to examine the changes in incidence of mental health diagnoses (depressive disorders, anxiety disorders, and adjustment disorders) and psychotropic medication prescribing (antidepressants, anxiolytics, hypnotics and sedatives, and antipsychotics) throughout the pandemic. To date, most of the studies were focused on the acute and short-term effects of the pandemic, and were based on survey-based research, with conclusions from many papers limited due to small sample sizes, unclear generalizability implications and lack pre-COVID-19 comparison. Using a retrospective cohort design, we will calculate incidence and prevalence rates of the studied outcomes, overall and by sex and age groups in a large longitudinal primary care database broadly representative of the Dutch population in terms of age and sex. |
| 2023-10 | Redefining polypharmacy: A population-based longitudinal study using real world data | The study aims to describe changes in polypharmacy over time, to identify patterns/trajectories, and to understand the association between these patterns and overall mortality. In this multi-national longitudinal cohort study, the investigators will use general practitioners’ (GPs) records from people aged 65 and above in the UK Clinical Practice Research Datalink (CPRD). The study measures the variation of polypharmacy over a five-year period using joint modelling and joint latent class modelling. The IPCI database will be used to study whether the model is applicable to other countries. The results of the study will enable clinical staff to identify people with polypharmacy and to design and use treatments for those who need them the most. |
| 2023-09 | Redefining and unravelling acute and long-term COVID-19 symptoms and complications: A large-scale multinational network cohort study | Many people suffer from long-term complications following acute COVID-19 infection, known as long COVID and "post-acute SARS-CoV-2 complications" (PASC). However, a comprehensive characterisation of the conditions has not yet been conducted. This study aims to (a) determine the incidence and prevalence of long COVID and PASC (b) characterise people with long COVID or PASC, and (c) model temporal trajectories and define clinical subgroups of long COVID. |
| 2023-08 | Time trends in prevalence, incidence and survival of leading cancer sites in the OHDSI Network | The main aim of this project is to estimate time trends in incidence and prevalence rates and short- and long-term survival of the most common cancers worldwide (breast, prostate, lung, cervix uteri, colorectal, stomach, liver, corpus uteri, thyroid, ovary, esophagus, non-Hodgkin lymphoma, bladder, leukemia, pancreas, kidney, lip-oral cavity, brain-central nervous system, melanoma of skin, larynx, multiple myeloma). This study will be a multinational observational cohort study and will be conducted using a network of large real world data sources that have been mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). |
| 2023-07 | Use of anticonception in females with underlying conditions | The aim of this study is to study the incidence and prevalence of different anticonceptive methods in women with underlying chronic comorbidity. Researchers will conduct a retrospective cohort study using data from the IPCI database. Within the IPCI database we will define a cohort of women (12-55 years) during the study period (2010-2022). Within this cohort, we will calculate the prevalence as well as the incidence of use of anticonceptives over time. Incident use is defined as first use of the anticonceptive method of interest (hormone therapy, IUD, surgery or barrier method) during follow-up. |
| 2023-06 | Patient-level prediction modelling in the OHDSI data network: different prediction tasks for methodological prediction research | In this study, researchers investigate how to develop patient-level prediction models using real-world data in three distinct domains: lung cancer, dementia, and depression. The study aims to improve the utility of the developed models by enhancing predictive performance and/or interpretability. The proposed methodological prediction research includes (a) exploring different data pre-processing techniques (e.g. dimensionality reduction, variable selection), (b) investigating different classifiers / algorithms (e.g. LASSO, tree-based methods, deep learning, exhaustive search algorithms), (c) developing models with structured and unstructured data (e.g., clinical notes), and (d) generating explanations for the developed prediction models (e.g., feature importance, counterfactual explanations). |
| 2023-05 | Characterizing the prevalence of multimorbidity in IPCI | With increasing ageing, multimorbidity poses challenges for patient care in terms of diagnosis, treatment, and cost for patient systems worldwide. Multimorbidity can be defined as the co-occurrence of two or more chronic conditions and has been estimated to affect up to 95% of the primary care population aged 65 years and older. Electronic Health Care Data offers an opportunity to study multimorbidity in patient populations to identify disease subtypes, disease clusters and ultimately define a better care management. This research aims to quantify the prevalence of multimorbidity. Further, the study will describe disease onset and associative temporality, quantify associations between diseases, report on age stratified groups, and analyse findings between gender. |
| 2023-04 | The extraction of clinical concepts from Dutch unstructured text and the comparison of the extracted concepts to the structured data in a primary care setting | This study aims to evaluate an open-source framework for the extraction of clinical concepts from Dutch clinical free-text, to characterize a multitude of clinical events in the database using the concepts extracted from their surrounding notes, and to assess the similarity between the coded clinical events in the structured data and the extracted concepts in the unstructured text. |
| 2023-03 | Patient-level prediction modelling in the OHDSI data network: different prediction tasks for methodological prediction research | In this study, researchers investigate how to develop patient-level prediction models using real-world data in 5 distinct domains: hospital readmission, end-of-life care, asthma exacerbation, mortality in COPD and CVD in type 2 diabetes. The study aims to improve the utility of the developed models by enhancing predictive performance and/or interpretability. The proposed methodological prediction research includes (a) exploring different data pre-processing techniques (e.g. dimensionality reduction, variable selection), (b) investigating different classifiers / algorithms (e.g. LASSO, tree-based methods, deep learning, exhaustive search algorithms), (c) developing models with structured and unstructured data (e.g., clinical notes), and (d) generating explanations for the developed prediction models (e.g., feature importance, counterfactual explanations). |
| 2023-02 | Epidemiology and Burden of Imminent Subsequent Fractures in Postmenopausal Women | Previous studies have shown that a first fragility fracture increases the imminent risk of a subsequent fracture, which often takes place in the 12 to 24 months following the initial fracture. However, there is a lack of scientific literature on the characteristics of patients who have subsequent fractures and on their associated burden compared to single osteoporotic fractures. This study aims (a) to describe the characteristics of postmenopausal women with an imminent subsequent fracture, (b) to describe the incidence of imminent subsequent fractures amongst postmenopausal women, and (c) to estimate the impact of an imminent subsequent fracture on healthcare resource utilisation and direct costs amongst postmenopausal women. The study will be conducted in six European countries: the United Kingdom, France, Germany, Italy, The Netherlands, and Spain. |
| 2023-01 | DARWIN EU - Background rates of serious adverse events to contextualize safety signals in a clinical trial in adolescent and adult patients with severe asthma | During the evaluation of the safety results of a clinical trial in patients with severe asthma, differences in rates of serious adverse events were observed in the experimental treatment arm compared to the control arm. In order to contextualize these differences, this study aims to estimate in patients with severe asthma the i) rate of mortality due to any cause, ii) rate of mortality due to fatal infections, iii) rate of mortality due to cardiovascular events and iv) rate of severe cardiovascular events. Results will be stratified by calendar year as well as pre-pandemic (2015-2019) and post-pandemic (2020-2021), sex, age and country/database during the study period 2015-2021. The study is requested by the European Medicines Agency (EMA). In this study, data from 5 databases (4 countries) will used. |
| 2022-11 | Drug utilization studies for Designated Drugs of Regulatory Interest | DARWIN EU is an initiative created by the European Medicines Agency (EMA) to generate evidence from real-world healthcare data sources from across Europe. One area of research relates to estimating how often, what strengths, and for how long specific drugs of interest are prescribed. For regulators it is important to have access to this information as it provides insight in the uptake of specific drugs and whether use of these drugs changes over time influenced by regulatory measures such as drug suspension/withdrawal, change in labelling, safety warnings etc. In this study, researchers investigate the use of valproate and other anti-epileptic drugs in women of childbearing age, and the use of antibiotics from the WHO Watch list. |
| 2022-10 | Estimation of population-level incidence rates of Designated Medical Events | Primary care records provide a unique source of data for estimating the incidence and prevalence of health conditions, medication use, and other health-related events of interest. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. Regulators are interested to have measures of incidence of conditions known to be possibly caused by medicines, also known as Designated Medical Events (DMEs). EMA defined (June 2020) a total of 49 conditions as DMEs. Our objective is to calculate the incidence of these DMEs. |
| 2022-09 | Estimation of population-level incidence and prevalence of rare diseases in Europe | Regulators have created faster pathways for the approval of treatments for rare diseases. In order for a disease to be classified as rare, researchers need to know how common it is. Primary care records provide a unique source of data that for estimating the incidence and prevalence of health conditions. The DARWIN EU initiative from the European Medicines Agency (EMA) draws upon data from multiple European countries to inform decision making for the assignment of orphan medicines. The first set of rare diseases includes rare blood cancers, including multiple myeloma, acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myeloid leukaemia, diffuse Large B-Cell Lymphoma and follicular lymphoma. |
| 2022-08 | Natural history and survival extrapolation of prevalent cancers | Monitoring of trends in cancer incidence and survival are needed for the development, implementation and evaluation of health policies aiming to reduce the burden of disease. Clinical trial data is used with extrapolation techniques to estimate long-term overall survival. However, this extrapolation is often a key source of decision uncertainty. The aim of this project is to examine the survival of certain common and rare cancers using real world data. Using a retrospective cohort design, the study estimates the overall observed survival of the studied cancers stratified by age, gender, and other comorbidities and investigates how well standard survival functions predict the natural history of the studied cancers, 1, 5, or 10-years after diagnosis. |
| 2022-07 | Incidence and prevalence of Bell’s palsy in the Netherlands | By means of a retrospective cohort design, this study investigates the incidence rate and prevalence of Bell’s palsy. In addition, the study describes the management of Bell’s palsy in primary care. The study population will be all individuals 18 years or older with at least of 1 year of valid IPCI database history. Bell’s palsy will be identified by an automated search on ICPC code (N92) and management of Bell’s palsy will be identified via an automated search on ATC codes of interest. |
| 2022-06 | Utilization of antidementia treatments: a large longitudinal population-based study | We aim to characterize and analyse the use of the antidementia drugs. This study will run in parallel on the SIDIAP database, a Spanish primary care database. All individuals, at least 40 year or older with dementia, registered for at least 1 year and with at least 1 prescription of rivastigmine, galantamine, donepezil or memantine will be included. This study explores demographics, comorbidities and prescribing patterns. The duration of use and drug utilisation will be assessed by means of incidence rates (IR) and Kaplan Meier curves. |
| 2022-05 | Comparison of feature selection pipelines to develop parsimonious patient-level prediction models | This study investigates how to create parsimonious patient-level prediction models, i.e. models with a reduced set of variables. The researchers will compare different feature selection pipelines across different databases and prediction problems. |
| 2022-04 | Disambiguation of ICPC codes using unstructured text data | The objective of this research is to build a framework that can be used to determine the correct subclass of an ambiguous ICPC code. Some ICPC codes are too ambiguous, not detailed enough, for the use of patient cohort creation. Currently, these ICPC codes are often manually validated for a certain study to select patients with a specific subclass. A framework that helps with the distinction between multiple subclasses can aid or even automate this patient selection. The unstructured text in the database, around the time the code was assigned, can hold information that may determine the specific subclass. This study uses text data and different machine learning methods to create and evaluate models for the classification of ambiguous ICPC codes. |
| 2022-03 | External validation of a prediction model for the development of psoriatic arthritis in people with psoriasis | Up to thirty percent of people with psoriasis will develop psoriatic arthritis (PsA). Detection of people with psoriasis who are at increased risk for developing PsA is essential to aid early diagnosis and treatment and prevent irreversible joint damage. To date, no validated prediction tool has been created to identify people with psoriasis at risk of developing PsA. The aim of this project is to develop and externally validate a model that can predict the development of PsA in people with psoriasis. |
| 2022-02 | Development and validation of dementia prediction model in a network of observational databases | Many dementia prediction models have been developed, but only few have been externally validated. In this study the researchers investigate the quality of dementia model reporting as a possible cause for a lack of external validation and low clinical uptake of these models. To that end they will replicate and externally validate three existing dementia prediction models. In addition, the researchers will develop their own dementia prediction models and externally validate them in a network of observational databases, including IPCI. |
| 2022-01 | Using clinical knowledge encoded in the SNOMED medical terms hierarchy for patient-level prediction | World-wide, the Systematized Nomenclature of Medicine (SNOMED) is a standardized, multilingual vocabulary of clinical terminology that is used by physicians and other health care providers with a rich semantical structure that, for example, provides a rich hierarchical classification of diseases and relates findings to diseases. This study attempts to extract clinical knowledge encoded in the SNOMED medical terms hierarchy to automatically quantify this similarity (and dissimilarity) between medical concepts with the goal to improve the performance of patient-level prediction models. |
| 2021-10 | (Chronic) use of macrolides in patients with asthma and/or COPD. | Macrolides (e.g. erythromycin and azithromycin) are antibiotic agents, which also have anti-inflammatory effects. Results from clinical trials showed that macrolide treatment improves health outcomes in a range of obstructive airways diseases. Chronic use of macrolides is considered as treatment option for patients with asthma and/or COPD. By means of a drug utilisation study, the researchers want to explore the use of macrolides in patients with asthma and/or COPD. |
| 2021-09 | Association between use of inhaled corticosteroids and severe gastrointestinal events in patients with asthma and/or COPD. | With this study the researchers want to explore the association between use of inhaled corticosteroids (ICS) and risk of severe gastro-intestinal events. For this research, they will focus on patients with asthma and/or Chronic Obstructive Pulmonary Disease (COPD) as ICS use is mainly used in this population group. |
| 2021-08 | Study of exposure and use patterns of alternatives to ranitidine-containing medicines in patients treated with ranitidine. | Ranitidine has been suspended from the EU market due to the presence of low levels of N-Nitrosodimethylamine (NDMA) impurities (a potential carcinogenic substance). The unavailability of ranitidine-containing medicines is expected to cause patients to switch treatment to alternative medicines or alternative treatment strategies. By means of a drug utilisation study, the incident use of ranitidine and alternative drugs (other H2 receptor antagonists, proton pump inhibitors and antacids), treatment discontinuation of ranitidine and switching to alternative drugs will be investigated. |
| 2021-07 | Association between thrombosis with thrombocytopenia syndrome or thromboembolic events, and COVID-19 vaccines. | To provide insight in the magnitude of thrombosis related to COVID-19 vaccination the researchers will conduct a retrospective cohort study using data mapped to the OMOP CDM. As part of this research, within IPCI, a cohort of patients vaccinated to either viral vector COVID-19 vaccine or mRNA COVID-19 vaccine will be identified and both cohorts will be compared with regard to risk of thrombosis with thrombocytopenia and/or risk of (arterial or venous) thromboembolic events. In addition, amongst those vaccinated patients, risk factors of thrombosis with thrombocytopenia or thromboembolic events will be investigated. And finally treatment for thrombosis and/or thromboembolic events will be explored. |
| 2021-06 | Epidemiology, clinic and practice of diagnosis and treatment of Bell's Palsy. | The researchers want to conduct research into the treatment of Bell's Palsy in general practice. They will look at, among other things, the incidence, gender and age distribution in the Netherlands, the risk factors and underlying causes, neurological early symptoms and clinical variation, and the prognostic factors for recovery. |
| 2021-05 | Study of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-referral prescribing trends. | (Fluoro)quinolones, are broad spectrum antibiotics that are active against both Gram-negative and Gram-positive bacteria and are indicated in the management of certain bacterial infections. The use of (fluoro)quinolones has been associated with the risk of some serious adverse events, which involve the peripheral and central nervous system as well as tendons, muscles and joints. In November 2018, the EMA concluded that serious adverse reactions including tendon, muscle and joint disorders, neurologic and psychiatric disorders listed in the product information of different (fluoro)quinolones could in rare cases become long-lasting, and recommended cessation of prescriptions for milder, non-severe or self-limiting infections, and restrictions for other indications. The overall aim of this study is to evaluate the impact of the regulatory actions taken for (fluoro)quinolone containing medicinal products following the 2018 referral procedure. |
| 2021-04 | Systemic glucocorticoids in the treatment of COVID-19 and risks of adverse outcomes in COVID-19 patients in the primary and secondary care setting. | The objective of this study is to describe utilization of systemic glucocorticoids (e.g., dexamethasone, prednisolone, methylprednisolone or hydrocortisone) for treatment of COVID-19 in two types of setting: hospitalized (in hospital care) and ambulatory (any care received outside the hospital) within 90 days following COVID-19 diagnosis. The study is commissioned by the European Medicines Agency. |
| 2021-03 | Sensitivity analysis of design choices for monitoring adverse events of special interest in vaccine safety. | The objective of study is to generate background rates of adverse events of special interest (AESI) necessary for safety monitoring of the COVID-19 vaccines. This is requested by the European Medicines Agency. The study is implemented across the Observational Health Data Sciences and Informatics (OHDSI) collaborator network driven by the FDA protocol for Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring. |
| 2021-02 | Medication errors in patients with asthma and/or COPD patients in real life. | Medication errors (MEs) are a global health problem. Although previous research in the Dutch setting shows the severity of medication-related hospital admissions, no explicit research has been done into the incidence of MEs. The focus of this research with the IPCI database will be mainly on characterizing a subset of MEs with drug-drug interactions (DDIs), the use of contraindicated medication and dual medication in patients with asthma and COPD. In addition, individuals with MEs will be characterized and risk factors for MEs will be identified. |
| 2021-01 | Adherence by general practitioners to 5 HARM-Wrestling recommendations. | The HARM-Wrestling recommendations were published in Dutch in 2009. These recommendations were designed to reduce the number of hospital admissions related to medication. Not all recommendations were followed up and 16 indicators were identified that still had great potential for improvement. It is not known whether these new recommendations resulted in increased compliance. That is why the researchers want to investigate this for a selection of five indicators, for the years 2015-2019. |
| 2020-10 | Predicting and Recalibrating Outcomes Toward External Understanding Study (PROTEUS): a proof of concept for a cardiovascular clinical prediction model. | The objective of this large-scale patient-level predictive modelling study is to build new prediction models and externally validate an existing cardiovascular clinical prediction models (CPM) routinely used in clinical practice: the Pooled Cohort Equations. The Pooled Cohort Equations predict 10-year risk of atherosclerotic cardiovascular disease among adults without pre-existing cardiovascular disease. In this study, the researchers will collaborate with data partners to implement this existing prediction model against the OMOP Common Data Model using the OHDSI PatientLevelPrediction package. They will then apply the package across the participating data partners in the OHDSI community to characterize the target populations and estimate their baseline risk. Furthermore, the researchers will externally validate the performance of the models in real-world settings and determine the potential impact of recalibration on the model use in clinical practice. |
| 2020-09 | Patient-level predictive modelling in the OHDSI data network: predicting (a) hospital admission and (b) death. | The objective of this large-scale patient-level predictive modelling study is to develop models using multiple commonly used algorithms to predict for each visit of the patient to the general practitioner (a) hospital admission in the next 30, 60, and 90 days and (b) death in the next 30, 60 and 90 days. The classifiers will be trained on two distinct data sets. The first data set will constitute coded data only (that is, ICPC diagnosis, laboratory tests, etc.), and the second set will add free text. The researchers want to (a) assess whether they can predict hospital admissions and death, and (b) assess whether adding free text to coded data will improve the predictions. In a later stage, the study will be implemented across the OHDSI collaborator network to externally validate the models and assess their transportability across databases from a number of countries. |
| 2020-08_vs 2 | At 24H-ABPM, are the nocturnal systolytic blood pressure values necessary for CVE risk assessment? | With the 24 hour blood pressure measurements it is known that the mean nocturnal values can differ from the day values. In the category of non-dippers, which means that the nocturnal values do not fall sufficiently by 10%, this is used as a risk predictor. The non-dipping category is an independent risk for developing a cardio vascular event (CVE). In the Netherlands, the SCORE model is used to determine CVE risk (SCORE: Systematic Coronary Risk Evaluation, a European cohort study calculating the risk of CVE at a 10-year follow-up) looking at gender, smoking, tension, lipids aged 40-70 years. The researchers investigate what the nocturnal values add to the risk assessment for developing CVE and if we need the nocturnal values if we use the SCORE model. |
| 2020-07 | Gout in general practice; risk factors and treatment (addition to the research 2015/03). | In this study the researchers investigate whether the presence of gout is associated with future renal or cardiovascular morbidity and whether maintenance treatment with allopurinol reduces this risk. |
| 2020-06 | High dose ICS+LABA vs. Medium dose ICS+LABA+LAMA in patients with uncontrolled severe asthma – Characteristics of treatment response. | With this Retrospective Cohort Study, the researchers aim to explore patient characteristics of treatment response of patients with uncontrolled severe asthma to one of the following treatment categories: (1) high dose ICS+LABA, (2) medium dose ICS+LABA+LAMA and (3) high dose ICS+LABA+LAMA using real life data from 4 electronic health care databases from Europe: the Netherlands (IPCI), Denmark (Aarhus), Italy (HSD) and UK (CPRD). The researchers aim to investigate drivers of response to any of the three treatment options and to investigate the patient phenotype that best characterises this response. |
| 2020-05 | Hip fracture – global secular trends in incidence and post-fracture treatment and mortality; a multi-country, observational study based upon population-based health records. | This is a study of secular trends in hip fracture for incidence, mortality, and use of post-fracture treatment using a standardized methodology applied to electronica health record databases spread across Asia, Oceania, North and South America, Western and Northern Europe. |
| 2020-04 | Incidence, prevalence and treatment of COVID-19. | The researchers want to visualize the COVID epidemic and to use historical data to determine whether any potential candidates (e.g. hydroxychloroquine) for reuse have shown an effect on viral infections in the past. |
| 2020-03 | European non-interventional post-authorization safety study (PASS) related to adherence to the risk minimization measures for romosozumab by the EU-ADR Alliance. | The aim of this drug utilization PASS (post-authorization safety study) is to evaluate adherence to the cardiovascular Risk Minimalization Measures (RMMs) for the use of romosozumab in routine clinical practice in seven European countries. |
| 2020-02 | European non-interventional post-authorization safety study related to Serious Infections (SI) for romosozumab. | This is a European non-interventional post-authorization safety study (PASS) to evaluate the risk of SIs associated with the use of romosozumab in routine clinical practice compared with other available osteoporosis (OP) medications. |
| 2020-01 | European non-interventional post-authorization safety study (PASS) related to serious cardiovascular (CV) events of myocardial infarction (MI) and stroke, and all-cause mortality for romosozumab. | This is a European non-interventional post-authorization safety study (PASS) to evaluate the risk of serious CV events of MI and stroke, and all-cause mortality including CV death associated with the use of romosozumab in routine clinical practice compared with other available osteoporosis (OP) medications. |
| 2019-13 | Ranitidine and other histamine H2 receptor antagonists – a drug utilisation study. | Ranitidine is a competitive and reversible inhibitor of the action of histamine and indicated for the management of peptic ulceration, Gastro-Esophageal Reflux Disease (GERD), reflux oesophagitis and Zollinger-Ellison syndrome. Results of a preliminary laboratory analysis have shown the presence of N-Nitrosodimethylamine (NDMA), a human carcinogen, in ranitidine. At the request of the European Commission, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is collecting and evaluating data on ranitidine (and use of other H2 receptor antagonists) in Europe. This data should allow the EMA to assess how many patients have been exposed to ranitidine and thus potentially at risk of NDMA and whether a regulatory action to protect patients and public health at the EU level is warranted. With this drug utilisation study the researchers aim to determine drug utilisation and prescription patterns of medicinal products containing H2-receptor antagonists. These data will give insight on the number of patients using ranitidine and potentially at risk of NDMA. |
| 2019-12 | Utilisation and comparative safety of disease-modifying anti-rheumatic drugs (DMARDs) used for the treatment of rheumatoid arthritis: a multi-database real-world cohort study. | In this study the researchers first of all aim to characterize treatment patterns in patients newly diagnosed with rheumatoid arthritis in a drug utilization study. Secondly, they look at the comparative risk of serious adverse events such as infection, cancer and cardiovascular outcomes according to conventional synthetic disease modifying anti-rheumatic drugs used in a comparative safety study. Finally, the researchers aim to predict all the outcomes above separately for newly diagnosed rheumatoid arthritis patients in a prediction study. |
| 2019-11 | Comorbidities in osteoarthritis. | This research aims to examine: [1] prevalence and incidence of comorbidities in osteoarthritis and time sequence between osteoarthritis and comorbidities; [2] common clusters and impact of comorbidities in people with osteoarthritis; [3] association between commonly used osteoarthritis analgesics and comorbidities; and [4] consistency of osteoarthritis comorbidity patterns across countries. Four national/regional registration databases in the UK, Netherlands (IPCI database), Sweden and Spain will be used for aim 1-3. Finally data from different countries will be meta-analyzed (aim 4) for consistency between countries. |
| 2019-10 | Effectiveness of topical corticosteroids in children with atopic eczema in general practice. | The advice of the NHG standard eczema is to treat atopic eczema with a step-by-step strategy using topical corticosteroids. The current advice is to start with a class I corticosteroid for moderate eczema. However, starting with a more potent corticosteroid may lead to a faster recovery and thus fewer consultations and referrals than with a class I corticosteroid. The researchers want to investigate which treatment GPs initially start for children with atopic eczema and determine the relationship between this strategy and consultations or referral in general practice. |
| 2019-09 | The actual use of codes (SNOMED, RxNORM Extended and LOINC) in various observational databases and consequences for cohort definitions. | This study aims to investigate the concept usage patterns across different datasets and their impact on cohort identification to facilitate cross-institutional and network studies. For every standard concept in the OMOP CDM, the researchers will investigate if it is used at each site, and if used, which source code(s) are used at individual sites, and how differences in corresponding source codes impact the portability of cohort identification algorithms. |
| 2019-08 | Association between blood eosinophils and cancer in a real world setting. | Pathophysiologic data suggest that (blood and mucosal) eosinophils may protect against cancer, but data are conflicting and the role of eosinophils and their mediators could be cancer type dependent. As incidental finding in a previous study on high blood eosinophils levels and risk of severe asthma exacerbations, the researchers observed that the prevalence of cancer was higher in patients with low blood eosinophil counts (<150 cells/uL) vs. patients with high blood eosinophil counts (>300 cells/uL) and that high blood eosinophils protected against mortality. This case-control study is to further explore the association between blood eosinophils and cancer as well as mortality in the general population. |
| 2019-06 | Knee and hip osteoarthritis: prevalence, incidence, X-ray use, and referrals. | The first part of this study will describe the prevalence and incidence of knee and hip osteoarthritis under different ICPC codes. Also, an estimate will be made of the future trend of knee and hip osteoarthritis in the Netherlands until 2040. In addition, it will be investigated whether there are changes over time in the use of X-rays in general practice for knee and hip osteoarthritis after the introduction of the recommendation of the NHG standard to no longer use X-rays as a diagnostic tool. Finally, the current policy of GPs regarding referrals of patients with knee and hip osteoarthritis to secondary care orthopedics will be mapped out. This information will provide an indication of compliance with current guidelines regarding referral to secondary care by general practitioners in the Netherlands. |
| 2019-04 | Identifying resource use associated with exacerbations and routine care of COPD. | The open-source Observational Medical Outcomes Partnership Common Data Model (OMOP-CDM) enables the systematic analysis of different observational databases by giving them a common structure and coding. The European Health Data & Evidence Network (EHDEN) project looks to extend the use of the OMOP-CDM across Europe and understand its usefulness for regulatory and HTA purposes. In this study the researchers seek to understand the usefulness of the OMOP-CDM for HTA using COPD as a case study. They aim to do this by comparing estimates of various parameters including COPD exacerbations and healthcare resource utilisation on routinely collected primary care data in the Netherlands (i.e. IPCI) and on a version of IPCI that has been mapped to the OMOP-CDM. |
| 2019-03 | Evaluating the EHDEN tools for assessing safety signals identified by the Uppsala Monitoring Centre (WHO) using IPCI mapped to a Common Data Model: proof of concept study assessing Denosumab (risk of vasculitis) and Ceftriaxone (risk of hepatitis). | This is a proof-of-concept study evaluating EHDEN tools for post marketing drug safety surveillance (pharmacovigilance) with specific objectives: 1. to analyze previously identified signals by the Uppsala Monitoring Centre: the association between subcutaneous Denosumab use and the risk of vasculitis and the association between Ceftriaxone use and the risk of hepatitis in patients aged 75 years or older. 2. to develop prediction tools for the risk of these adverse drug reactions amongst users of these same drugs. 3. to detect new safety signals in iterative analyses of VigiBase (in 2020-2022), and to repeat steps 1 to 2 to expand the knowledge regarding the association between drug-ADR combinations detected and evaluate the possibility to confirm/reject them through IPCI data via the EHDEN tools. |
| 2019-02 | Drug utilization studies using IPCI mapped to a Common Data Model: an EHDEN proof of concept study assessing respiratory drug use in patients with asthma or COPD. | The European Health Data and Evidence Network (EHDEN) project is an international project supported by the Innovative Medicines Initiative (IMI) aiming to standardize health care data to a common data model (OMOP) and to develop and implement tools to facilitate research on large electronic health care databases. To investigate the validity and functionality of this approach, the researchers want to conduct a drug-utilisation study using IPCI mapped to a common data model. As first proof of concept study the researchers want to investigate characteristics of respiratory drug use in patients with asthma and chronic obstructive pulmonary disease (COPD) which are both prevalent conditions and primarily treated by GPs. By means of a drug utilisation study the researchers want to investigate i) the frequency of use (incidence and prevalence), ii) characteristics of patients initiating treatment with respiratory drugs, iii) treatment patterns and changes over time and iv) treatment adherence. In addition the researchers want to investigate whether the results of this study are consistent with the data as obtained when using the standard IPCI data (thus not mapped to the common data model). |
| 2019-01vs2 | Investigation of the link between allergies and metabolic diseases during different lifespan stages. | Both metabolic diseases and atopic disorders have been increasing worldwide, particularly in westernized countries. In most living multi-cellular organisms, metabolic homeostasis and the immune system influence each other in multiple manners. New insight into the possible link between atopy and metabolic disorders may provide clues for new treatment possibilities. The researchers are aiming to investigate this potential link with data from IPCI and Kinderhaven (an outpatient clinic of Erasmus MC). |
| 2018-06 | Incidence, prevalence and determinants of chronic cough in primary care. | By means of retrospective cohort study, the researchers want to investigate the following: (1) incidence and prevalence of chronic cough; (2) determinants of chronic cough with regard to lifestyle factors, comorbidity, drug use and (3) treatment of chronic cough in primary care. |
| 2018-02 | Risks and benefits of bisphosphonate use in patients with chronic kidney disease: a population-based cohort study. | The researcher want to study at first: the association between the use of oral bisphosphonates and the progression (stage worsening or entering renal replacement therapy/transplant) of kidney disease. Secondly: the relationship between oral bisphosphonate use and incident symptomatic fractures. Thirdly: the risk of adverse events (upper gastro-intestinal events, hypocalcemia/hypophosphatemia, or acute kidney injury) amongst users of oral bisphosphonates, compared to matched non-users. |
| 2018-01 | Chronic inflammatory demyelinating polyneuropathy (CIDP): incidence, prevalence and medical care in the Netherlands. | In this study, the researcher in the IPCI cohort wants to determine the incidence and prevalence of CIDP and to map the current diagnosis and treatment of CIDP. |
| 2017-14 | Proof of concept study for large-scale patient-level predictive modelling in the OHDSI data network: a case study on patients with diabetes. | The objective of this large-scale patient-level predictive modelling study is to develop models using 5 commonly used classifiers for two ‘at risk’ cohorts (Type 1 Diabetes,Type 2 Diabetes) to predict Cardiovascular Disease (CVD) outcomes. The study is implemented across the OHDSI collaborator network to externally validate the models and assess their transportability across databases from a number of countries. |
| 2017-12 | Investigating the relationship in paediatric population between antibiotics dosing of antibiotics (prescribed, dispensed or administered) and patient’s weight. | In this study the researchers would like to assess in European Medical Information Framework (EMIF) Electronic Healthcare Records (EHR) databases (DBs) the relationship between dosing of antibiotics prescribed, administered or dispensed (either for outpatients or inpatient settings) to children (age 0-18 yr), and their weight, age and height. |
| 2017-10 | High blood eosinophil levels as independent risk factor of severe asthma exacerbations and mortality in adult patients with asthma. | By means of a retrospective cohort study in multiple European Electronic Primary Care databases, including IPCI, the researchers want to study the effect of blood eosinophils as risk factor of severe asthma exacerbations and mortality in adult patients with asthma. |
| 2017-09 | Adherence to the guidelines of the NHG (Dutch General Practitioners association) for the diagnosis of hypertension in primary care. | The diagnosis of hypertension must be based on multiple consultation room measurements on several days, a 30-minute method or an ambulatory 24-hour measurement. Diagnoses made on a one-off measurement can lead to over- and under-treatment. The researcher studies the extent to which the criteria for diagnosing hypertension in primary care are met. It is also being studied whether there has been an improvement in the quality of the diagnosis of hypertension in the last 10 years since the publication of the 2006 standard. |
| 2017-08 | Prevalence of hypoglycaemia in patients treated with a sulphonurea for diabetes mellitus type 2. | In this study, the researcher wants to determine the rate of hypoglycaemia in patients treated with a sulphonurea (SU) derivative, called glimepiride and gliclazide. |
| 2017-07 | Prescription of methylphenidate in adults and associated adverse reactions. | This study studies the determinants associated with the prescription of methylphenidate in adults. In addition, it is investigated which determinants are associated with the occurrence of severe cardiovascular and psychiatric endpoints in adult users of methylphenidate / other amphetamines. |
| 2017-06 | Determinants of Metoprolol prescribing. | In this study the researcher studies within the IPCI database whether new female starters on metoprolol are dosed differently than men, or stop earlier due to side effects. |
| 2017-05 | Prevalence of disabling spasticity in stroke patients in the Netherlands. | The aim of this study is to determine the prevalence of bothersome spasticity in a large group of stroke patients by determining the use of drug therapy in stroke patients. |
| 2017-04 | Comparative effectiveness of alendronate and raloxifene in reducing the risk of hip fracture. | Osteoporosis is characterized by decreased bone mass and deterioration of bone tissue, resulting in reduced bone strength and increased fracture risk. Alendronate and raloxifene are anti-resorptive therapies approved for the prevention and treatment of postmenopausal osteoporosis. This study aims to compare the effectiveness in reducing the risk of hip fracture between alendronate and raloxifene and to evaluate the adverse reactions of both medications. |
| 2017-03 | Investigating Birth Month-Disease Risk Relationships Across the OHDSI Network. | Derive data on birth month-disease risk relationships from large healthcare organizations/hospitals and healthcare facilities across the United States of America and throughout the world. Integrative analysis will be performed using established climate models, and knowledge of environmental factors that vary by season and climate. |
| 2017-02 | Proof of concept study for large-scale patient-level predictive modelling in the OHDSI data network: a case study on depression. | The objective of this large-scale patient-level predictive modelling study is to develop models using 5 commonly used classifiers for a single ‘at risk’ cohort (pharmaceutically treated depression cohort) and 22 ‘outcome’ cohorts. |
| 2017-01 | Clinical prediction rules for appendicitis in young patients in primary care. | In this study the reseacher investigates the validity of seven existing clinical decision rules for appendicitis in children with acute abdominal pain in primary care. Also is evaluated whether the use of the CRP test, in addition to these decision rules, has added diagnostic value. |
| 2016-09 | Treatment pathway analysis: An evaluation of treatment patterns and drug utilization amongst incident dementia cases in Electronic Health Records databases. | The rich and diverse collection of healthcare data sources available in the European Medical Information Framework (EMIF) presents an unprecedented opportunity to study patterns of drug usage. An objective of EMIF is to enable researchers to use Electronic Health Record (EHR) data to analyze treatment patterns in a specific population through an end user application providing a platform for future treatment pathway analysis within EMIF. More specifically, this study will utilize EHR data to investigate patterns of drug treatment in incident cases of dementia, and also, if feasible, in a subset of these patients with clinically diagnosed Alzheimer’s disease. |
| 2016-07 | Management of childhood asthma in primary care and safety of inhaled corticosteroids. | According to the existing asthma guidelines, children with asthma are treated according to a step-by-step plan. Men start using a short-acting bronchodilator. If this is not enough, an inhaled corticosteroid (ICS) will be started and the dose will either be increased or a long-acting bronchodilator will be added. Once the respiratory complaints are under control, the guidelines recommend halving the dose of ICS after 3 months of therapy (step-down therapy). Based on epidemiological research, the researcher wants to map the therapy pattern of children with asthma with a focus on step-down therapy. The researcher also wants to investigate how often asthma remission occurs. |
| 2016-06 | Laboratory tests in children in primary care. | The reason, frequency, and composition of laboratory tests ordered in children in primary care is not known. There might be overuse of laboratory testing (for example in fatigue) and underuse of laboratory testing (for example in screening for elevated glucose levels in obese children ≥ 10 year). Research into current clinical practice with regard to laboratory testing in children in primary care is lacking. The objective of the current observational study is to unravel this current practice using the IPCI database. |
| 2015-13 | The use of amitriptyline for musculoskeletal complaints in general practice. | This study will investigate how often amitriptyline is prescribed and for which musculoskeletal complaints this is mainly done. |
| 2015-12 | The use of third-choice pain medications by osteoarthritis patients in general practice. | Pain is a common problem in osteoarthritis. These pain complaints are often treated conservatively by the GP. Adequate pain relief is often not achieved with paracetamol and NSAIDs. The doctor can then take various follow-up steps. This IPCI study examines how often various follow-up steps, namely opiates, corticosteroid injections and amitriptyline, are prescribed and in what order. Furthermore, it will be investigated whether there are changes over time. It will also be examined which (patient) characteristics are associated with the prescription of this medication. In addition, it will be investigated how long patients use them for opiates. |
| 2015-06 | Tobacco control policy and incidence of respiratory infections and asthma in children. | This study examines whether the introduction of important tobacco control measures in the Netherlands is associated with a reduction in the number of diagnoses of respiratory infections and wheezing / asthma in children in general practice. |
| 2015-03 | Gout in general practice; risk factors and treatment. | In this study, risk factors for gout and the frequency of gout attacks are investigated. It is investigated whether the presentation of gout is an indicator of renal or cardiovascular morbidity in the future, and whether maintenance treatment with allopurinol actually reduces the frequency of gout attacks. |
Overview of collaborative projects
European Health Data and Evidence Network (EHDEN)
Europe is generating huge amounts of patient-level information contained in Electronic Health Record (EHR) systems and other types of health databases. These include structured data in the form of diagnoses, medications, laboratory test results, and unstructured data in clinical narratives. The Electronic Health Data in a European Network (EHDEN) Consortium leverages these vast volumes of data to improve future clinical practice and individual patient outcomes by increasing our understanding of disease and treatment pathways. EHDEN will galvanize transparent and reproducible analytics that will generate valid real-world evidence to improve patient care, and enable medical outcomes-based research at an unprecedented scale. The EHDEN Consortium provides the infrastructure and eco-system supporting disease-specific projects in the IMI Big Data for Better Outcomes (BD4BO) programme. The core of EHDEN is the use of a common data model (OMOP-CDM), standardised outcome assessment (ICHOM), and transparent open-source analytics (OHDSI). The objective of the EHDEN consortium is to provide all the necessary services that enable a distributed European data network to perform fast, scalable and highly reproducible research, while respecting privacy regulations, local data provenance and governance. This will include services and tools to perform data standardization, analytical pipelines, tools to share study results, and tools for stakeholder engagement and training. The EHDEN Consortium combines active participation of stakeholder representatives with proven experience in: a) integrating different data types, methods and technologies to utilize diverse clinical datasets; b) platform development to make methods and datasets Findable, Accessible, Interoperable and Reusable (FAIR); and c) engaging a wide variety of stakeholders, including health technology assessment agencies, regulators and patients.
IPCI is participating in multiple use cases in EHDEN.
European COVID-19 Observational Research Exchange (ECORE)
In June 2020, EMA contracted the company IQVIA with a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients (press release). This project will include the identification of large national cohorts of COVID-19 patients and appropriate comparator groups, the development of a study protocol template for multinational studies as well as the establishment of a collaborative framework for researchers. The project will be carried out in collaboration with the European Health Data & Evidence Network (EHDEN) consortium, which was established under the Innovative Medicines Initiative and includes the Erasmus Medical Centre in Rotterdam and the University of Oxford as project lead and research coordinator, respectively.
The IPCI database is participating in a proof-of-concept study.
Ranitidine Drug Utilisation Study
Ranitidine is a competitive and reversible inhibitor of the action of histamine, released by enterochromaffin-like (ECL) cells, at the histamine H2-receptors on parietal cells in the stomach. It is indicated for the management of peptic ulceration, Gastroesophageal Reflux Disease (GERD), reflux oesophagitis, Zollinger-Ellison syndrome, chronic episodic dyspepsia, peptic ulcer hemorrhage, prophylaxis of stress ulceration, Mendelsons syndrome, duodenal ulcers, benign gastric ulcers, post-operative ulcer, symptomatic relief of heart burn, dyspepsia (acid indigestion), hyperacidity, and prevention of symptoms associated with consuming food and drink. Ranitidine is available for oral and parenteral administration.
The EU authorities were notified of the results of a preliminary laboratory analysis of ranitidine showing the presence of N-Nitrosodimethylamine (NDMA). The results on a limited sample of products showed that for the majority of both ranitidine APIs and finished products, NDMA was above the acceptable intake established during the referral procedure under Article 31 of Directive 2001/83/EC for sartans with a tetrazole ring (considering the maximum daily dose authorised in the EU, and long-term use in a 50 kg adult). Following extensive validation of the analytical method, the presence of NDMA in ranitidine finished products was confirmed.
The objective of this project is to rapidly generate information about prescribing and use patterns of ranitidine-containing medicines in EU Member States that will inform on the population at risk of exposure to NDMA (or other nitrosamines) through use of ranitidine.
The OMOP-CDM process applied in this study has been been presented at a workshop organised by the EMA at the ICPE conference (more information)
Project SCYLLA
An international cohort of OHDSI collaborators obtained a grant from the COVID-19 Therapeutics Accelerator to lead an effort to compare the effectiveness of treatments, including corticosteroids such as dexamethasone, under current evaluation for COVID-19 across an international observational data network. The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments.
Researchers from the University of Oxford, Columbia University, UCLA and Erasmus University Medical Center are leading this work through Project SCYLLA (SARS-Cov-2 Large-scale Longitudinal Analyses), one of the emerging efforts to come from OHDSI’s global work surrounding COVID-19 research.
The IPCI Database is used in this study.
OHDSI Network Studies
The Observational Health Data Sciences and Informatics (or OHDSI, pronounced "Odyssey") program is a multi-stakeholder, interdisciplinary collaborative to bring out the value of health data through large-scale analytics. OHDSI aims to generate accurate, reproducible, and well-calibrated evidence and promote better health decisions and better care. All our solutions are open-source. OHDSI has established an global network of researchers and observational health databases with a central coordinating center housed at Columbia University, see www.ohdsi.org.
IPCI is participating in many studies executed by the OHDSI community, including the work done on COVID-19 (link)