The risk of acute infection in association with first ever diagnosed depression: a cohort study.

Purpose: To assess the risk of acute infections in patients with first ever diagnosed depression compared to patients with no diagnosed depression in a primary-care database.

Methods: We conducted a cohort study using the UK CPRD GOLD database (2000-2019). We identified patients aged 18 years or older with a recorded Read code for depression (cohort entry date) and compared them to patients with no Read codes for depression using risk set sampling.

Treatment for osteoporosis and risk of osteonecrosis of the jaw among female patients in the United Kingdom Clinical Practice Research Datalink.

Unlabelled: Osteonecrosis of the jaw (ONJ) is an adverse effect of antiresorptives. Among female patients treated for osteoporosis, ONJ risk was threefold higher after 2-3 years of treatment and eightfold after 10 years compared with past use. Absolute risks remained low (~ 0.

Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data.

Purpose: We describe constructs designed to protect the integrity of the results from comparative analyses using real-world data (RWD): staging and clean room.

Methods: Staging involves performing sequential preliminary analyses and evaluating the population size available and potential bias before conducting comparative analyses. A clean room involves restricted access to data and preliminary results, policies governing exploratory analyses and protocol deviations, and audit trail.

Presence of Breast Cancer Information Recorded in United Kingdom Primary Care Databases: Comparison of CPRD Aurum and CPRD GOLD (Companion Paper 1).

Purpose: To evaluate the presence of data elements related to diagnosis and treatment of malignant breast cancer in CPRD Aurum compared to those in the previously validated CPRD GOLD.

Methods: Females in CPRD Aurum or GOLD with a first-time code for malignant breast cancer, mastectomy, or ≥1 prescription for tamoxifen or aromatase inhibitors (2004-2019) were selected. We compared the presence of the codes for breast cancer diagnosis, surgeries (mastectomy, lumpectomy), tamoxifen and aromatase inhibitor prescriptions, radiation, chemotherapy, and supporting clinical codes (suspected breast cancer, lump symptoms, biopsy, lumpectomy, cancer care, referral/visit to specialist, palliative care).

Use of the CPRD Aurum Database: Insights Gained from New Data Quality Assessments.

Ongoing evaluation of any electronic health data source is critical to assess suitability for its use in medical research. In addition, familiarity with a data source's history and recording practices is important for making informed data source selection, study design choices, and interpretation of results. In this commentary, the authors discuss three studies that assessed different aspects of the quality and completeness of information contained in Clinical Practice Research Datalink (CPRD) Aurum compared to the well-established CPRD GOLD and to other linked data sources, with the aim to describe insights gained through these data quality assessments.

Comparison of Rheumatoid Arthritis Information Recorded in UK CPRD Aurum and CPRD GOLD Databases (Companion Paper 3).

Purpose: To report distribution of codes associated with a rheumatoid arthritis (RA) diagnosis recorded in Clinical Practice Research Datalink (CPRD) Aurum compared to the previously validated CPRD GOLD database as a critical step toward making decisions about CPRD Aurum's suitability for medical research.

Patients And Methods: We analyzed the distribution of codes for RA diagnoses, labs, and treatments in the new CPRD Aurum database, compared to the CPRD GOLD database by selecting relevant indicators of RA diagnosis, treatment, and clinical care. We included all patients in England in CPRD Aurum and CPRD GOLD with an incident diagnosis code for RA on or after 1 January 2005 and at least two years recorded data before first RA diagnosis.

Correctness and Completeness of Breast Cancer Diagnoses Recorded in UK CPRD Aurum and CPRD GOLD Databases: Comparison to Hospital Episode Statistics and Cancer Registry (Companion Paper 2).

Purpose: To evaluate the new Clinical Practice Research Datalink (CPRD) Aurum database, we estimated 'correctness' (ie accuracy, validity) and 'completeness' (ie presence, missingness) of malignant breast cancer diagnoses recorded in CPRD Aurum compared to external linked data sources: Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Outpatient (OP), and Cancer Registry (CR), and to the previously validated CPRD GOLD.

Methods: Linkage-eligible, female patients with incident malignant breast cancer diagnosis recorded in at least one study data source were selected. Correctness was the proportion of malignant breast cancer cases recorded in CPRD Aurum or GOLD who also had a diagnosis recorded in HES APC/OP (2004-2019) or CR (2004-2016).

Incomplete capture of apremilast in Clinical Practice Research Datalink Aurum: An example of exposure misclassification of specialty treatments in United Kingdom general practice databases.

Purpose: Nearly all apremilast users captured in Clinical Practice Research Datalink (CPRD) Aurum have only one prescription, which is inconsistent with its prescribing pattern. The goal of this study was to assess capture of apremilast prescriptions in CPRD Aurum by comparison to CPRD GOLD and general practitioner (GP) questionnaires.

Methods: We compared the number of apremilast prescriptions for patients in Aurum to (1) those in GOLD and (2) those reported by the GPs via questionnaire responses.

Pharmacologically Treated Anxiety and Depression in People Diagnosed with von Willebrand Disease: Matched Cohort Study.

Background: People diagnosed with von Willebrand disease (VWD) have reduced quality of life versus the general population, and there is limited evidence of increased rates of anxiety and/or depression among people diagnosed with VWD.

Aim: To understand the association between VWD and mental health outcomes.

Design And Setting: A retrospective cohort study was conducted using the UK Clinical Practice Research Datalink (CPRD) GOLD database (1988-2016).

Migraine and risk of hypertensive disorders of pregnancy: A population-based cohort study.

Background: Migraine is associated with hypertensive disorders of pregnancy through common pathophysiological features. This study evaluates the association between migraine diagnosis and treatment, and risk of hypertensive disorders of pregnancy.

Methods: We conducted a prospective cohort study in the Clinical Practice Research Datalink GOLD, a large longitudinal database of patient records in the UK.

Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data.

Purpose: Evaluation of drug safety during pregnancy is dependent on the number of exposed women during routine clinical practice with data available for analysis. We examined medication fills in pregnant and nonpregnant women within select disease cohorts: general population, migraine, diabetes, and hyperlipidemia to explore the potential use of claims data to assess medication use and safety during pregnancy.

Methods: This cohort study, using IBM MarketScan® Research Databases claims data, included women 10-54 years of age with pregnancy resulting in a liveborn infant between January 2010 and September 2015 and matched nonpregnant women.

Pre-pregnancy migraine diagnosis, medication use, and spontaneous abortion: a prospective cohort study.

Background: Migraine is common among females of reproductive age (estimated prevalence:17-24%) and may be associated with reproductive health through underlying central nervous system excitability, autoimmune conditions, and autonomic dysfunction. We evaluated the extent to which pre-pregnancy migraine diagnosis and medication use are associated with risk of spontaneous abortion (SAB).

Methods: We analyzed data from a preconception study of pregnancy planners (2013-2021).

Quality of rheumatoid arthritis recording in United Kingdom Clinical Practice Research Datalink Aurum.

Purpose: While several studies have assessed quality and completeness of recording acute medical events in Clinical Practice Research Datalink (CPRD) Aurum, evaluation of additional chronic conditions is warranted.

Methods: We selected patients with a first diagnosis of rheumatoid arthritis (RA) coded in their CPRD Aurum record between 2005 and 2019. We assessed quality of RA diagnosis by evaluating additional information in the patient record that would corroborate the diagnosis.

Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink.

Introduction: This real-world safety analysis was requested by the European Medicines Agency following approval of apremilast, an oral treatment for psoriasis or psoriatic arthritis.

Objective: We aimed to compare incidence rates of adverse events of special interest identified a priori, in patients receiving apremilast with those receiving other systemic treatments for psoriasis or psoriatic arthritis.

Methods: This 5-year cohort study was conducted in Clinical Practice Research Datalink GOLD between January 2015 and June 2020.

Antimicrobial drug use and the risk of glioma: A case-control study.

Background: The use of antibiotics has been associated with increased risks of various cancers. Comprehensive information on the association of antibiotic use with the risk of glioma is lacking.

Methods: We performed a large case-control study based on the Clinical Practice Research Datalink (CPRD) GOLD from the United Kingdom.

Impact of von Willebrand Disease on Women's Health Outcomes: A Matched Cohort Database Study.

To understand the impact of von Willebrand disease (VWD) on women's health, a retrospective cohort study was conducted using UK Clinical Practice Research Datalink (CPRD) GOLD database and Hospital Episode Statistics (HES) Admitted Patient Care data from 1988 to 2016. Hysterectomy and heavy menstrual bleeding (HMB) events were identified by recorded disease/clinical codes and compared in women with and without VWD (matched 1:10 by birth and CPRD record start years [±2 years], and general practice attended). Incidence rates and incidence rate ratios (IRR) were calculated; risks were estimated using the Kaplan-Meier method.

Non-steroidal anti-inflammatory drugs and risk of myocardial infarction adjusting for use of proton pump-inhibitors in patients with no major risk factors: a nested case-control study in the UK Clinical Practice Research Datalink.

Aims: Studies have found an increased risk of myocardial infarction (MI) in association with some non-steroidal anti-inflammatory drugs (NSAIDs). We evaluated this association in patients without major cardiovascular risk factors and assessed potential reverse causality bias.

Methods And Results: In this nested case-control study of patients aged 40-79 in Clinical Practice Research Datalink GOLD who received at least one NSAID prescription between 2006 and 2019, we found 8639 MI cases and 34 556 matched controls.

Presence of Codes for Indication for Use in Clinical Practice Research Datalink Aurum: An Assessment of Benign Prostatic Hyperplasia Treatments.

Background: Assessments of strengths and limitations of new data sources are critical for making decisions about suitability for specific research questions. For some studies, it is necessary to capture a drug's indication for use.

Objective: To assess the presence of indications for prescription use in Clinical Practice Research Datalink (CPRD) Aurum (January 1988-June 2021) by describing the proportion of men in CPRD Aurum who had a recorded indication for use of prescriptions for 5-alpha reductase inhibitors (5-ARI), alpha blockers (AB), or tadalafil, which have multiple indications.

Characterization of the deterioration of diabetes control in patients with a subsequent diagnosis of pancreatic cancer: A descriptive study.

Background: Deterioration of diabetes control can be the first harbinger of pancreatic cancer. However, little is known about how to distinguish patients with pancreatic cancer-related diabetes deterioration from those with type 2 diabetes progression. We aimed to characterize the glycated hemoglobin (HbA) and body weight profile of pancreatic cancer patients with deteriorating diabetes before the cancer diagnosis.

Glucocorticoids and Risk of Venous Thromboembolism in Asthma Patients Aged 20-59 Years in the United Kingdom's CPRD 1995-2015.

Background: Glucocorticoids, the class of steroids used in management of asthma, have been observed to be associated with adverse events such as increased coagulation and inhibition of fibrinolysis. This study evaluated the risk of VTE in relation to the use of glucocorticoids in patients with asthma.

Methods: We conducted a nested case-control study among patients aged 20-59 years with asthma who received at least one glucocorticoid prescription during 1995-2015 in the UK-based Clinical Practice Research Datalink GOLD.

β-Blockers and the Risk of Depression: A Matched Case-Control Study.

Introduction: Depression is a commonly cited adverse effect of β-blockers but the evidence for a causal relationship is limited.

Objective: We aimed to explore whether β-blockers are associated with an increased risk of new-onset depression.

Methods: We conducted a case-control study using the UK population-based Clinical Practice Research Datalink (CPRD) GOLD.

Association between glycemic control and risk of venous thromboembolism in diabetic patients: a nested case-control study.

Background: Previous studies suggested an elevated risk of venous thromboembolism (VTE) among patients with type 2 diabetes mellitus (T2DM), with a possible sex difference. The impact of glycemic control on the risk of VTE is unclear. Our objective was to analyze the association between glycemic control and the risk of unprovoked (idiopathic) VTE in men and women with T2DM.

Quality and Completeness of Myocardial Infarction Recording in Clinical Practice Research Datalink Aurum.

Background: Validation studies of the Clinical Practice Research Datalink (CPRD) Aurum database in the UK are critical for making decisions about its suitability and validity for research purposes.

Objective: To examine data source agreement of myocardial infarction (MI) diagnoses recorded in CPRD Aurum compared with linked Hospital Episode Statistics (HES) data. This comparison provides information on CPRD Aurum data correctness (accuracy, validity) and completeness (presence, missingness).

The Risk of Venous Thromboembolism (VTE) in Men with Benign Prostatic Hyperplasia Treated with 5-Alpha Reductase Inhibitors (5ARIs).

Background: Many men receive 5-alpha reductase inhibitors (5ARIs) for ongoing treatment of benign prostatic hyperplasia (BPH). The increased risk of cardiovascular complications with 5ARIs has been documented in BPH studies and the occurrence of cerebral venous thrombosis, presumably due to increased estrogen level following 5ARI use, was described in multiple case reports. The objective of this study was to determine if 5ARIs with or without alpha blockers (AB) were associated with an increased risk of venous thromboembolism (VTE) in males with BPH.