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Purpose To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. Methods A retrospective multidatabase cohort study using CPRD primary care and linked secondary care data to describe the characteristics of populations of patients with COPD. Patients' demographic and lifestyle factors, comorbidity profile, spirometry measurements and treatment changes were evaluated, as was the distribution of follow‐up time and types of losses during follow‐up. Characteristics were evaluated using descriptive statistics. Results A total of 322 991 patients from 1148 primary care practices in the United Kingdom across two CPRD primary care databases, CPRD GOLD and CPRD Aurum, were potentially eligible to participate in a hypothetical trial using CPRD, starting on 31 December 2017. Patients with COPD in CPRD GOLD and CPRD Aurum were comparable in terms of age (median age 70 vs. 68 years), gender (50% vs. 52% male), disease severity (e.g., 25% vs. 24% Medical Research Council [MRC] dyspnoea score grades 3–5) and history of respiratory conditions (e.g., 43% vs. 38% asthma). High proportions of patients with COPD in CPRD GOLD and CPRD Aurum were available on 31 December 2012 for follow‐up at 1, 2, and 5 years (92%, 85% and 67%, respectively). Conclusions Patients and data from CPRD GOLD and CPRD Aurum were comparable across key aspects relevant to COPD trials. A pragmatic trial using CPRD to recruit patients with COPD is scientifically feasible.

This study measured the exposure to different categories of medicinal products discussed by the European Union (EU) Pharmacovigilance Risk Assessment Committee from September to November 2018 in four electronic primary care health databases: IQVIA Medical Research Data-UK, IQVIA Medical Research Data-France, IQVIA Medical Research Data-Germany, and Clinical Practice Research Datalink Aurum, in the entire lifespan of each database until August 31, 2018. The assessment of 83 centrally authorized products and 45 nationally authorized products showed that coverage was better for products marketed for longer duration and worse for orphan drugs. The ability to detect associations against hypothetical comparators was better for more common events and for larger effect sizes. Coverage of advanced therapies was worse for those typically administered in a specialized rather than primary care setting. This study shows that to enable better informed regulatory decisions there is a need to access complementary data sources, particularly capturing secondary care prescribing.

ObjectivesWe aimed to evaluate recording of antibiotic prescribing from two primary care electronic health record systems.DesignCohort study.SettingUK general practices contributing to the Clinical Practice Research Datalink (CPRD) databases: CPRD GOLD (Vision data) and CPRD Aurum (EMIS data). English CPRD GOLD general practices were analysed as a subgroup, as all CPRD Aurum practices were located in England.Participants158 305 patients were randomly sampled from CPRD Aurum and 160 394 from CPRD GOLD.Outcome measuresAntibiotic prescriptions in 2017 were identified. Age-standardised and sex-standardised antibiotic prescribing rates per 1000 person years were calculated. Prescribing of individual antibiotic products and associated medical diagnoses was evaluated.ResultsThere were 101 360 antibiotic prescriptions at 883 CPRD Aurum practices and 112 931 prescriptions at 290 CPRD GOLD practices, including 112 general practices in England. The age-standardised and sex-standardised antibiotic prescribing rate in 2017 was 512.6 (95% CI 510.4 to 514.9) per 1000 person years in CPRD Aurum and 584.3 (582.1 to 586.5) per 1000 person years in CPRD GOLD (505.2 (501.6 to 508.9) per 1000 person years if restricted to practices in England). The 25 most frequently prescribed antibiotic products were similar in both databases. One or more medical codes were recorded on the same date as an antibiotic prescription for 72 989 (74%) prescriptions in CPRD Aurum, 84 756 (78%) in CPRD GOLD and 28 471 (78%) for CPRD GOLD in England. Skin, respiratory and genitourinary tract infections were recorded for 39 035 (40%) prescriptions in CPRD Aurum, 41 326 (38%) in CPRD GOLD, with 15 481 (42%) in English CPRD GOLD practices only.ConclusionEstimates for antibiotic prescribing and infection recording were broadly similar in both databases suggesting similar recording across EMIS and Vision systems. Future research on antimicrobial stewardship can also be conducted using primary care data in CPRD Aurum.

ObjectiveWe evaluated whether recording of antibiotic prescribing across two primary care electronic health record (EHR) systems is similar. Data were analysed from the Clinical Practice Research Datalink (CPRD) databases: CPRD GOLD (Vision data) and CPRD Aurum (EMIS data).MethodsCohorts of patients were randomly sampled from both databases, stratifying by general practice, age-group and gender. All antibiotic prescriptions in 2017 were identified. Age- and sex-standardised antibiotic prescribing rates per 1,000 person years were calculated. Prescribing of individual antibiotic products and associated medical diagnosis recorded on the same date was also evaluated. English CPRD GOLD general practices were analysed as a subgroup, because all CPRD Aurum practices sampled were in England.ResultsThere were 101,360 antibiotic prescriptions among 158,305 sampled patients at 883 CPRD Aurum practices, and 112,931 prescriptions among 160,394 sampled patients at 290 CPRD GOLD practices. The age- and sex-standardised antibiotic prescribing rate in 2017 was 512.6 (95% confidence interval 510.4 to 514.9) per 1,000 person years in CPRD Aurum and 584.3 (582.1 to 586.5) per 1,000 person years in CPRD GOLD [505.2 (501.6 to 508.9) per 1,000 person years if restricted to practices in England]. The 25 most frequently prescribed antibiotic products were similar in both databases. One or more medical codes were recorded on the same date as an antibiotic prescription for 72,989 (74%) prescriptions in CPRD Aurum, 84,756 (78%) in CPRD GOLD, and 28,471 (78%) for CPRD GOLD in England. Skin, respiratory and genito-urinary tract infections were recorded for 39,035 (40%) prescriptions in CPRD Aurum, 41,326 (38%) in CPRD GOLD, with 15,481 (42%) in English CPRD GOLD practices only.ConclusionSimilar estimates for antibiotic prescribing and infection recording were found for both databases suggesting similar recording across EMIS and Vision systems. Future research on antimicrobial stewardship can be conducted in CPRD Aurum informed by previous results from CPRD GOLD. It may also be possible to combine CPRD GOLD and CPRD Aurum data in research on antibiotic prescribing.

OBJECTIVES: Atrial fibrillation (AF) is the most common cardiac rhythm disorder with a significant health burden. The aim of this study was to characterise patients with recently diagnosed AF and to estimate the rates of comorbidities and outcome events requiring hospitalisation in routine clinical practice. DESIGN: Pharmacoepidemiological cohort study using observational data. METHODS/SETTING: This study included 16 513 patients with a first diagnosis of AF between 1 January 2005 and 28 February 2010 (newly diagnosed patients) using data from the UK Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) and the Office for National Statistics mortality data. Exposure was stratified by vitamin K antagonist (VKA) exposure (non-use, current, recent and past exposure) based on prescriptions and/or international normalised ratio measurements, and followed for outcome events of interest based on diagnosis codes in the databases, that is, vascular outcomes, bleeding events and others. The main focus of the study was on outcome events requiring hospitalisation using the HES data. RESULTS: The incidence of vascular outcome hospitalisations (myocardial infarction (MI), stroke or systemic arterial peripheral embolism) was 3.8 (95% CI 3.5 to 4.0)/100 patient-years. The incidence of stroke was 0.9 (0.8 to 1.1) during current VKA exposure, 2.2 (1.6 to 2.9) for recent, 2.4 (1.9 to 2.9) for past and 3.4 (3.1 to 3.7) during non-use. MI incidence was 0.7 (0.6 to 0.9) for current VKA exposure, 0.7 (0.4 to 1.2) for recent, 1.1 (0.8 to 1.5) for past and 1.9 (1.7 to 2.1) during non-use. The incidence of bleeding event hospitalisations was 3.8 (3.4 to 4.2) for current VKA exposure, 4.5 (3.7 to 5.5) for recent, 2.7 (2.2 to 3.3) for past and 2.9 (2.6 to 3.2) during non-use; 38% of intracranial bleeds and 6% of gastrointestinal bleeds were fatal. CONCLUSIONS: This population-based study from recent years provides a comprehensive characterisation of newly diagnosed patients with AF and incidence estimates of common outcomes with a focus on hospitalised events stratified by VKA exposure. This study will help to place future data on new oral anticoagulants into perspective.

Objective. Assess risk of cardiac events and mortality among users of olanzapine and other antipsychotics relative to nonusers. Methods. The General Practice Research Database was used to identify cohorts of antipsychotic users and nonusers with psychiatric illness. Outcomes included cardiac mortality, sudden cardiac death (SCD), all-cause mortality (excluding suicide), coronary heart disease (CHD), and ventricular arrhythmias (VA). Results. 183,392 antipsychotic users (including 20,954 olanzapine users) and 193,920 psychiatric nonusers were identified. There was a significantly higher rate of cardiac mortality (adjusted RR [aRR]: 1.53, CI, 1.12–2.09) in olanzapine users relative to psychiatric nonusers, consistent with findings for both atypical and typical antipsychotics. Relative to psychiatric nonusers, no increased risk of all-cause mortality was observed among olanzapine users (aRR: 1.04, CI, 0.93–1.17), but elevated all-cause mortality risk was observed when compared to all antipsychotic users (aRR: 1.75, CI, 1.64–1.87). There was no increased risk of CHD or VA among olanzapine users relative to psychiatric nonusers, consistent with findings for atypical but not typical antipsychotics. SCD cases were uncommon. Conclusions. Use of antipsychotic agents was associated with increased risk of all-cause and cardiac mortality. Patients treated with olanzapine were found to be at increased risk of cardiac mortality versus psychiatric nonusers.

Background Epididymo-orchitis is a common urological presentation in men but recent incidence data are lacking. Guidelines for management recommend detailed investigation and treatment for sexually transmitted pathogens, such as Chlamydia trachomatis. Data from secondary care indicate that these guidelines are poorly followed. It is not known how epididymo-orchitis is managed in UK general practice. Aim To estimate the incidence of cases of epididymo-orchitis seen in UK general practice, and to describe their management. Design of study Cohort study. Setting UK general practices contributing to the General Practice Research Database (GPRD). Method Men, aged 15-60 years, consulting with a first episode of epididymo-orchitis between 30 June 2003 and 30 June 2008 were identified. All records within 28 days either side of the diagnosis date were analysed to describe the management of these cases (including location) and to compare this management with guidelines. Results A total of 12 615 patients with a first episode of epididymo-orchitis were identified. The incidence was highest in 2004-2005 (25/10 000) and declined in the later years of the study. Fifty-seven per cent (6943) of patients were managed entirely within general practice. Of these, over 92% received an antibiotic, with ciprofloxacin being the most common one prescribed. Only 18% received a prescription for doxycycline. Most men, including those under 35 years, had no investigation recorded and fewer than 3% had a test for chlamydia. Conclusion These results indicate low rates of specific testing and treatment for sexually transmitted infections in males who attend general practice with symptoms of epididymo-orchitis. There is a need for further research to understand the pattern of care delivered in general practice.

Background Studies of cancer incidence and early management will increasingly draw on routine electronic patient records. However, data may be incomplete or inaccurate. We developed a generalisable strategy for investigating presenting symptoms and delays in diagnosis using ovarian cancer as an example. Methods The General Practice Research Database was used to investigate the time between first report of symptom and diagnosis of 344 women diagnosed with ovarian cancer between 01/06/2002 and 31/05/2008. Effects of possible inaccuracies in dating of diagnosis on the frequencies and timing of the most commonly reported symptoms were investigated using four increasingly inclusive definitions of first diagnosis/suspicion: 1. "Definite diagnosis" 2. "Ambiguous diagnosis" 3. "First treatment or complication suggesting pre-existing diagnosis", 4 "First relevant test or referral". Results The most commonly coded symptoms before a definite diagnosis of ovarian cancer, were abdominal pain (41%), urogenital problems(25%), abdominal distension (24%), constipation/change in bowel habits (23%) with 70% of cases reporting at least one of these. The median time between first reporting each of these symptoms and diagnosis was 13, 21, 9.5 and 8.5 weeks respectively. 19% had a code for definitions 2 or 3 prior to definite diagnosis and 73% a code for 4. However, the proportion with symptoms and the delays were similar for all four definitions except 4, where the median delay was 8, 8, 3, 10 and 0 weeks respectively. Conclusion Symptoms recorded in the General Practice Research Database are similar to those reported in the literature, although their frequency is lower than in studies based on self-report. Generalisable strategies for exploring the impact of recording practice on date of diagnosis in electronic patient records are recommended, and studies which date diagnoses in GP records need to present sensitivity analyses based on investigation, referral and diagnosis data. Free text information may be essential in obtaining accurate estimates of incidence, and for accurate dating of diagnoses.

Background Asthma management guidelines recommend a stepwise approach to instituting and adjusting anti-inflammatory controller therapy for children with asthma. The objective of this retrospective observational study was to describe prescribing patterns of asthma controller therapies for children in a primary care setting. Methods Data from the UK General Practice Research Database were examined for children with recorded asthma or recurrent wheezing who, from September 2006 through February 2007, were ≤ 14 years old at the time of a first asthma controller prescription after ≥ 6 months without a controller prescription. We evaluated demographic characteristics, asthma duration, comorbidities, asthma-related health care resource use, and prescribed daily dose of controller medication. In addition, physicians for 635 randomly selected patients completed a survey retrospectively classifying asthma severity at the prescription date and describing therapy and health care utilization for 6 prior months. Results We identified 10,004 children, 5942 (59.4%) of them boys, of mean (SD) age of 8.0 (3.8) years. Asthma controller prescriptions were for inhaled corticosteroid (ICS) monotherapy for 9059 (90.6%) children; ICS plus long-acting β2-agonist (LABA) for 698 (7.0%); leukotriene antagonist monotherapy for 91 (0.9%); ICS plus leukotriene antagonist for 55 (0.6%); and other therapy for 101 (1.0%), including 45 (0.45%) children who were prescribed LABA as monotherapy. High doses of ICS (> 400 μg) were prescribed for 44/2140 (2.1%) children < 5 years old and for 420/7452 (5.6%) children ≥ 5 years. Physicians reported asthma severity as intermittent for 346/635 (55%) patients and as mild, moderate, and severe persistent for 159 (25%), 71 (11%), and 11 (2%), respectively (severity data missing for 48 [8%]). The baseline characteristics and controller therapy prescriptions of the survey cohort were similar to those of the full cohort. Conclusions Physician classifications of asthma severity did not always correspond to guideline recommendations, as leukotriene receptor antagonists were rarely used and high-dose ICS or add-on LABA was prescribed even in intermittent and mild disease. In UK primary care, monotherapy with ICS is the most common controller therapy at all levels of asthma severity.