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. We report recording of diagnoses, prescriptions, labs, and referrals expected to be present based on NICE guidelines for RA management. RESULTS: There were 53 083 patients with a first recorded RA diagnosis during the study period: 43606 (82%) patients had RA drug treatments in their record, 7596 (14%) had supporting codes without drug treatment, and 1881 (4%) patients had only a RA diagnoses recorded in their medical record with no supporting codes or RA treatments. Patients with RA diagnosis only were more likely to be first diagnosed in the earliest time period of study. Labs for diagnosing and monitoring RA were most common among patients with RA treatment. Analgesic and glucocorticoid prescriptions were common in all study patients but were highest among patients with RA treatment. Among patients with RA diagnosis only, the overwhelming majority had only one RA diagnosis recorded (76%). CONCLUSIONS: Our findings suggest that codes expected for monitoring and treatment of RA are routinely recorded in CPRD Aurum. These results support previous assessments, which found data recorded in CPRD Aurum to be of good quality for use in research.

The risks of major cardiac events among patients with psoriatic arthritis treated with apremilast, biologics, DMARDs or corticosteroids.

OBJECTIVES: People with PsA are at increased risk of cardiovascular disease. The objective of this study was to quantify the risk of myocardial infarction (MI), stroke and revascularizations in people with apremilast-treated PsA compared with patients receiving other PsA treatments. METHODS: We conducted a cohort study of 68 678 patients with PsA treated with apremilast, TNF inhibitor (TNF-i) biologics, IL-17 or -12/23 biologics, conventional DMARDs or CS in the United States MarketScan database. Cohort entry was date of first study drug after 21 March 2014. Cases were patients with MI, stroke or revascularization. We calculated incidence rates (IRs) and incidence rate ratios for each outcome by exposure. RESULTS: We identified 292 MI, 151 stroke and 475 revascularizations cases. IRs for MI were lowest for users of TNF-i biologics [1.4 per 1000 person-years (PY)] and similar for all other treatments, including apremilast, ranging from 1.8 to 3.8 per 1000 PY. IRs were similar for all treatments for both stroke (0.1-1.6 per 1000 PY) and revascularization (3.1-5.1 per 1000 PY). IRs for apremilast were 2.5 per 1000 PY for MI, 1.6 per 1000 PY for stroke and 3.3 per 1000 PY for revascularization. CONCLUSION: In patients with treated PsA, IRs of MI, stroke and revascularization were low for all systemic treatments evaluated. Although the number of events was small, apremilast exposure did not signal potential acute cardiovascular harm and was not associated with a material increase in the risk of these serious cardiac events.

CPRD Aurum database: Assessment of data quality and completeness of three important comorbidities.

PURPOSE: The Clinical Practice Research Datalink (CPRD) now provides a new medical record database, CPRD Aurum. This is the second of several studies being undertaken to assess the quality of CPRD Aurum data for research. METHODS: We included patients aged 20+, with at least one lab test result of any type from a random sample of 50 000 patients in CPRD Aurum. We assessed whether diagnosis codes for type 2 diabetes, hyperlipidemia, and iron deficiency or unspecified anemia were accompanied by supporting codes including lab results and treatments (correctness) and whether lab results, treatments, or other codes indicate a missing diagnosis record (completeness). RESULTS: Among 37 502 patients in CPRD Aurum, correctness of type 2 diabetes, hyperlipidemia, and anemia diagnoses was high (99%, 93%, and 97%, respectively). Completeness was only high for type 2 diabetes (94%-98%); completeness for hypercholesterolemia and anemia diagnoses was modest even when the presence of treatments and lab results indicated the conditions were likely present (51%-59% and 58%-70%, respectively). CONCLUSIONS: Our findings indicate that for studies of type 2 diabetes, hyperlipidemia, and iron deficiency or unspecified anemia, the diagnosis code is likely to be correct where present. However, a significant proportion of cases of hyperlipidemia or anemia will be missed if only diagnosis codes are used to select patients with these conditions. Researchers should consider using treatments, supporting codes, and, when available, lab data to supplement diagnosis codes and enhance case capture when including these conditions in studies using CPRD Aurum.

Quality and completeness of diagnoses recorded in the new CPRD Aurum Database: evaluation of pulmonary embolism.

PURPOSE: The Clinical Practice Research Datalink (CPRD) now provides a new medical record database, CPRD Aurum. This is the first of several studies being undertaken to assess the quality and completeness of CPRD Aurum data for research endeavors. METHODS: We identified patients with a pulmonary embolism (PE) diagnosis from a random sample of 50 000 patients in CPRD Aurum and compared the diagnoses using data from Hospital Episode Statistics (HES). We calculated the proportion of PE cases recorded in CPRD Aurum who also had a PE diagnosis recorded in HES. We also evaluated completeness by identifying all PE diagnoses in HES and calculating the proportion also present in CPRD Aurum. RESULTS: The study included 781 PE patients: 580 had a PE in CPRD Aurum, 632 had a PE in HES, and 431 had a PE in both. The proportion of patients with anticoagulated PE in CPRD Aurum confirmed by HES was 76.8%. The completeness of primary hospitalized PE HES events compared to CPRD Aurum was 79.1%. In most instances, there was a plausible explanation for the presence of a PE in only one of the two data sources. CONCLUSIONS: The results of this study are reassuring and suggest that the correctness (eg, quality, accuracy) and completeness of diagnosis information in CPRD Aurum are promising with respect to serious acute conditions that require medical attention. Evaluation of other data elements will provide additional insight into this new data resource and its utility for medical research.

Associations of antibiotic use with risk of primary liver cancer in the Clinical Practice Research Datalink.

BACKGROUND: Use of antibiotics could alter human microbiota composition and decrease bacterial diversity. Such microbial dysbiosis may have implications in hepatocarcinogenesis; however, the association between antibiotic use and liver cancer risk has been minimally examined in humans. METHODS: We performed a nested case-control study (1195 primary liver cancer cases and 4640 matched controls) within the United Kingdom's Clinical Practice Research Datalink. Antibiotic use was obtained from prescription records. Multivariable-adjusted odds ratio (OR) and 95% confidence interval (CI) were estimated using conditional logistic regression. RESULTS: Ever-use of prescription antibiotics was associated with a slightly increased risk of liver cancer, compared to non-use (OR=1.22, 95% CI=1.03-1.45). However, there was no clear dose-response relationship by the number of prescriptions or cumulative dose of antibiotic use, suggesting a non-causal association. CONCLUSIONS: Our results do not support a role of antibiotic use in liver cancer development.

Rates of Cancers and Opportunistic Infections in Patients With Psoriatic Arthritis Compared With Patients Without Psoriatic Arthritis.

OBJECTIVES: This study aimed to estimate rates of cancer or opportunistic infection in patients with psoriatic arthritis (PsA) compared with patients without PsA. METHODS: Using the Clinical Practice Research Datalink, we conducted a cohort study of patients with a PsA diagnosis and patients without such diagnosis, matched on age, sex, general practice, and calendar time, to assess the incidence of cancers (solid, hematologic, and nonmelanoma skin cancer) and opportunistic infections. We estimated incidence rates (IRs) and IR ratios (IRRs) with 95% confidence intervals (CIs) for each outcome and stratified results in the PsA cohort by receipt of systemic PsA drugs. RESULTS: The rate of hematologic cancer was slightly higher in the PsA cohort compared with the non-PsA cohort (IRR, 1.52; 95% CI, 1.10-2.10), whereas the rates of solid cancer and of nonmelanoma skin cancer were similar between the PsA and non-PsA cohorts (IRR, 1.01; 95% CI, 0.90-1.13; and IRR, 0.97; 95% CI, 0.82-1.14, respectively). Incidence rates were higher for PsA patients who received prescriptions for PsA drugs compared with those who did not. The IRs for infection were higher in the PsA compared with the non-PsA cohort (IRR, 1.39; 95% CI, 1.31-1.47) and were significantly higher in patients who received prescriptions (IRR, 1.71; 95% CI, 1.52-1.91). CONCLUSIONS: The rates of solid and nonmelanoma skin cancers were similar in patients with PsA compared with patients without PsA, but the rates of hematologic cancer and opportunistic infections were higher in patients with PsA. In patients with PsA, rates of all outcomes were higher among those who received prescriptions for systemic PsA therapy.

Incidence rates of suicidal behaviors and treated depression in patients with and without psoriatic arthritis using the Clinical Practice Research Datalink.

OBJECTIVE: To estimate rates of suicidal behaviors and treated depression in patients with psoriatic arthritis (PsA) in comparison to non-PsA patients. METHODS: Using the Clinical Practice Research Datalink, we conducted a cohort study of patients with PsA compared to non-PsA patients. Patients with codes for suicidal behaviors (ideation, attempts, and suicide) and treated depression (diagnosis plus anti-depressant prescription) recorded during follow-up were identified as cases. We estimated incidence rates (IRs) and incidence rate ratios (IRRs) with 95% confidence intervals (CIs) for each outcome and stratified results in the PsA cohort by receipt of systemic PsA drugs. RESULTS: The rates of suicide ideation, attempt, and suicide were similar for PsA and non-PsA patients [IRR = 0.99 (95%CI: 0.67-1.47), IRR = 1.07 (95%CI: 0.86-1.34), and 0.34 (95%CI: 0.05-2.48), respectively] and rates of suicidal behaviors were slightly higher among PsA patients who received PsA drugs compared to those who did not. PsA patients had slightly higher rate of treated depression compared to non-PsA patients [IRR = 1.38 (95%CI: 1.27-1.49)] and were significantly higher in PsA patients who received drugs [IRR = 1.59 (95%CI: 1.35-1.86)]. CONCLUSIONS: Rate of depression was higher in patients with PsA compared to non-PsA patients. The rate of suicidal behaviors was similar between the two cohorts.

Rates of Cardiovascular Disease and Major Adverse Cardiovascular Events in Patients With Psoriatic Arthritis Compared to Patients Without Psoriatic Arthritis.

BACKGROUND: Few studies report estimates of cardiovascular disease (CVD) or major adverse cardiovascular events (MACE) in patients with psoriatic arthritis (PsA). OBJECTIVE: To estimate rates of incident CVD and MACE in patients with PsA compared to patients without PsA. METHODS: Using the Clinical Practice Research Datalink, we conducted 2 cohort studies of patients with PsA compared to patients without PsA or psoriasis matched on age, sex, general practice, and calendar time: 1 study of CVD and 1 study of MACE. In each study, we excluded patients who had a study outcome before cohort entry. Cases were patients with a first-time diagnosis of CVD or MACE recorded during follow-up. We estimated incidence rates (IRs) and incidence rate ratios (IRRs) with 95% confidence intervals (95% CI) and stratified results in the PsA cohort by exposure to systemic PsA treatments. RESULTS: The IR of CVD was higher in the patients with PsA compared to those without PsA (12.8/1000 person-years [PYs] [95% CI, 11.9-13.7] and 9.6/1000 PYs [95% CI, 9.3-9.0]; IRR, 1.33 [95% CI, 1.23-1.44]). The IR of MACE was slightly higher in the PsA compared to the non-PsA cohort (4.6/1000 PYs [95% CI, 4.1-5.1] and 3.5/1000 PYs [95% CI, 3.4-3.7]; IRR, 1.30 [95% CI, 1.15-1.47]). Among the patients with PsA, IRs were higher for those who received PsA treatments for both outcomes but did not differ significantly by type of treatment received. CONCLUSIONS: The rates of CVD and MACE were slightly higher in the patients with PsA compared to the patients without PsA. Among the patients with PsA, rates of both outcomes were higher among those who received prescriptions for systemic PsA treatments.

The risk of adverse outcomes in association with use of testosterone products: a cohort study using the UK-based general practice research database.

AIMS: To study the relative safety of the intramuscular injection formulation of testosterone with oral testosterone undecanoate in relation to the risks for hypertension, polycythemia, prostate cancer, benign prostatic hypertrophy (BPH) and prostatism. METHODS: We conducted a cohort study of men in the UK based General Practice Research Database who were users of the oral undecanoate and injectable forms of testosterone and calculated rates and relative risks of hypertension, polycythemia and prostate conditions (cancer, BPH and prostatism). RESULTS: We identified 5841 men who received at least one study testosterone preparation. There were 202 cases of hypertension (crude incidence rates (IRs) for oral and injectable testosterone respectively 12.3/1000 person-years (PY) and 14.4/1000 PY). There were 146 cases of polycythemia (IRs 1.2/1000 PY and 10.1/1000 PY), 46 cases of prostate cancer (IRs 2.5/1000 PY and 1.8/1000 PY), 106 cases of BPH (IRs 4.1 /1000 PY and 2.1/1000 PY), and 251 cases of prostatism (IRs 8.4/1000 PY and 6.1/1000 PY respectively). Adjusted relative risks for oral compared with injectable testosterone were 0.8 (95% CI 0.6, 1.2) for hypertension, 0.13 (0.05, 0.35) for polycythemia, 1.1 (0.7, 1.7) for prostate cancer, 1.5 (1.1, 2.2) for BPH and 1.1 (0.8, 1.4) for prostatism. CONCLUSIONS: Risks of prostate cancer and prostatism were similar in users of the two preparations, but risks were higher for hypertension and polycythemia in the injectable compared with the oral testosterone users. Risk of BPH was slightly higher in the oral users, but the difference was small and could have been due to bias.

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). Methods: People diagnosed with VWD were matched 1:10 to randomly selected people in the database without VWD based on sex, birth year ±2 years, CPRD record start year ±2 years, and general practice attended. Individuals were followed from VWD diagnosis or match date to censoring (first event date, CPRD end date, or death). Treated anxiety and treated depression were identified by a diagnostic Read Code and a prescription for anxiety/depression medication recorded within 90 days of each other, after VWD diagnosis/match date. Results: Treated anxiety was recorded in 89 of 1119 (8.0%) people diagnosed with VWD and 624 of 10,423 (6.0%) without VWD (age- and sex-adjusted incidence rate ratio [IRR], 1.37; 95% confidence interval [CI], 1.10-1.71). Treated depression was recorded in 119 of 1083 (11.0%) people diagnosed with VWD and 846 of 9845 (8.6%) without VWD (adjusted IRR, 1.35; 95% CI, 1.11-1.63). Females aged 20-39 and 0-19 years were at greatest risk for treated anxiety and treated depression, respectively. Conclusion: Higher rates of treated anxiety and depression were observed among people diagnosed with versus without VWD, predominantly in young females.

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. Results: We found 53,083 and 18,167 patients with a new diagnosis code for RA in CPRD Aurum and CPRD GOLD, respectively. In both databases approximately 67% were female with similar mean ages at first diagnosis. There were few differences in RA-related recording patterns between the two data sources. Before first RA diagnosis, CPRD Aurum patients had more RA-specific labs and other supporting clinical codes. After diagnosis, CPRD Aurum patients had more RA diagnoses coded and more often had 10+ general RA labs than patients in CPRD GOLD. More CPRD GOLD patients had 10+ prescriptions for conventional disease-modifying antirheumatic drugs (cDMARD) compared to CPRD Aurum. Otherwise, the distribution of drugs used to treat RA was similar between databases. The standardized incidence of RA was similar between databases. Conclusion: Overall, among patients with a diagnosis code for RA, recording of diagnoses, prescription drugs, and labs were similar between CPRD Aurum and CPRD GOLD. Slight differences were found for a few variables, but overall, we found consistency between the databases. In addition, standardized incidence of RA was similar between databases.

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. Our findings support the view that CPRD Aurum and GOLD are both valuable tools for studies based on information recorded in primary care but should not be used without critical consideration of strengths and limitations. Further, use of linked data should be considered for some studies, after taking into account all relevant factors.

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). Completeness was estimated by identifying all malignant breast cancer diagnoses in HES APC/OP or CR and calculating the proportion with a concordant diagnosis in CPRD Aurum or GOLD. Results: Compared to HES APC/OP, there were 85,659 and 31,452 eligible patients in CPRD Aurum and GOLD, respectively. Correctness estimates were high (CPRD Aurum 83.5%, GOLD 81.7%). Compared to CR, there were 70,190 and 29,597 eligible patients in CPRD Aurum and GOLD, respectively: correctness was 89.1% for CPRD Aurum and 88.2% for GOLD. Completeness estimates for CPRD Aurum and GOLD were high (>90%). Diagnoses were recorded in CPRD Aurum within -7 to 74 days of those in the linked sources. Reasons for discordant diagnostic coding included presence of treatment or other clinical codes only, diagnosis coded after end of follow-up, non-malignant breast cancer in linked data, and administrative codes in lieu of diagnostic codes. Conclusion: These results indicate that correctness and completeness of malignant breast cancer diagnoses in CPRD Aurum were high and similar to CPRD GOLD. This provides confidence in use of CPRD Aurum for research purposes. Where complete case capture is important, researchers should consider linkage to HES APC or CR.

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). Age standardized incidence rates of breast cancer diagnosis in CPRD Aurum and GOLD were calculated. Results: There were 131,936 eligible patients in CPRD Aurum and 69,102 patients in GOLD. A similar proportion of patients in CPRD Aurum and GOLD had codes for breast cancer diagnosis, mastectomy, drug prescriptions, lump, biopsy, lumpectomy, chemotherapy, and cancer and palliative care coded in their electronic record during follow-up. However, suspected breast cancer, radiation, and referral/visits to specialists were coded more frequently in patients in CPRD Aurum compared to GOLD. Age-standardized incidence rates were similar for CPRD Aurum and GOLD. Conclusion: Overall, there was consistency between data elements related to malignant breast cancer recorded in CPRD Aurum and GOLD, particularly for the most informative clinical details. These findings provide reassurance that breast cancer information recorded in CPRD Aurum is generally comparable to that recorded in the previously validated CPRD GOLD and support the use of CPRD Aurum for breast cancer research.

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

Objective: 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. Materials and Methods: 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. Results: HMB was recorded after cohort entry in 388 of 1,335 women (29.1%) with VWD and 1,524 of 12,463 women (12.2%) without VWD. The cumulative incidence of HMB was higher in women with versus without VWD across all ages (p < 0.0001), and irrespective of prior HMB status (p < 0.001). Women with VWD were more likely to have HMB compared with women without VWD; IRR adjusted for age and prior HMB status was 2.74 (95% confidence interval [CI]: 2.44-3.07). Hysterectomy was recorded in 88 of 1,374 women (6.4%) with VWD and 320 of 12,791 women (2.5%) without VWD. The cumulative incidence of hysterectomy was higher for women with versus without VWD (p < 0.0001), and highest among women aged ≥30 years at cohort entry. Women with VWD aged 30 - 39 years were more likely to undergo hysterectomy than women without VWD; IRR adjusted for prior HMB was 3.58 (95% CI: 2.36 - 5.44). Conclusions: These findings highlight the substantial impact of VWD on women's health.

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. Methods: From a random sample of 154 practices of CPRD Aurum data, we selected 85,597 male patients with a prescription for a 5-ARI, an AB, or tadalafil. Among these patients, we described presence of codes indicating whether the patient had benign prostatic hyperplasia, hypertension, erectile dysfunction, or alopecia using three indication definitions: narrow (specific diagnoses recorded within one year before and up to 90 days after the prescription), broad (specific diagnoses or supporting clinical codes in the time period described above), and widest (diagnoses or supporting codes recorded at any time before the prescription and up to 90 days after the prescription). Results: Using the narrow indication definition limited to diagnoses only, 39,861 (46.6%) patients' records contained an indication for use. The broad definitions, which additionally included supporting codes, captured indications for 62,912 (73.5%) patients and the widest definition, which additionally included supporting codes and all available data before the first prescription date, captured indications for 71,478 (83.5%) patients. Indications were present more often for prescriptions in 2005 and later (85.9%). Conclusion: The findings of this assessment suggest that CPRD Aurum can be used for studies that require information on treatment indications for BPH and potentially for treatments of other chronic diseases managed in the primary care setting.

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). METHODS: Patients with MI diagnoses recorded in either data source were selected from a random sample of 50,000 patients in CPRD Aurum with HES linkage (1997-2017). Correctness was defined as the proportion of MI cases in CPRD Aurum with a concordant MI diagnosis recorded in HES or with strong supporting evidence in either data source. Completeness was defined as the proportion of patients with primary HES-coded MIs with strong supporting evidence that were also present in CPRD Aurum. RESULTS: There were 1260 patients with MI recorded in the CPRD Aurum sample. The overall correctness of the recorded MI diagnoses was 94%: 986 patients (78%) had concordant diagnoses in HES within 90 days; 123 (10%) were concordant with HES, but with an inconclusive date and another 71 (6%) had strong supporting evidence for being a true MI case. There were 1125 patients with MI recorded in HES primary diagnosis fields with strong supporting evidence in either data source. Of these, 880 (78%) were present in CPRD Aurum, with completeness somewhat higher in more recent years. CONCLUSION: MI diagnoses recorded in CPRD Aurum were highly likely to be correct, supporting its use in clinical research studies. Completeness was lower, indicating the need for data linkage for some studies.

Herpes Zoster, Hepatitis C, and Tuberculosis Risk with Apremilast Compared to Biologics, DMARDs and Corticosteroids to Treat Psoriasis and Psoriatic Arthritis.

PURPOSE: Psoriasis and psoriatic arthritis (PsA) are associated with an increased infection risk. In this cohort study of patients with treated psoriasis or PsA, we used MarketScan (2014-2018) to estimate rates of herpes zoster, hepatitis C (HepC) and tuberculosis (TB) with apremilast compared to other systemic treatments. MATERIALS AND METHODS: Patients were exposed from first apremilast [APR], DMARD, TNF-inhibitor [TNF], IL-inhibitor [IL], or corticosteroids [CS] prescription after March 21, 2014. Study exposures were APR, DMARDs only, TNF-only, IL-only, CS-only, DMARDs+CS, TNF+DMARDs and/or CS, IL+DMARDs and/or CS. Cases had treated herpes zoster, HepC, or TB event. We calculated incidence rates (IRs) [95% confidence intervals] per 1000 patient-years. RESULTS: The study population included 131,604 patients. For herpes zoster (N=2271), IRs were highest for users of DMARDs+CS (12.5 [9.8-15.7]), CS-only (12.5 [10.4-14.1]), and TNF+DMARDs and/or CS (11.9 [10.6-13.4]), compared with DMARDs only (9.9 [8.7-11.2]). IRs were lowest for users of IL-only (6.7 [5.8-7.8]) and APR (7.0 [5.8-8.4]). IRs of HepC (N=150) and TB (N=81) were low and between-treatment differences were not significant. CONCLUSION: Rates of herpes zoster varied by treatment: highest among those who received polytherapy, lowest in users of apremilast only. IRs for HepC and TB were low for all exposures.

The origin and spread of a mumps epidemic: United kingdom, 2003-2006.

BACKGROUND: The United Kingdom (UK) underwent a massive epidemic of mumps from 2003 through 2006. The origin and spread was mapped in 350 general practices that used office computers to contribute comprehensive medical information on approximately 3 million patients to the General Practice Research Database (GPRD). METHODS: The continuous 3-month cumulative incidence of mumps (2003-2006) was estimated by dividing the number of diagnosed cases of mumps each 3 months by the population at risk according to age, region, practice, and calendar time. The effect of the measles, mumps, and rubella (MMR) vaccine was estimated by comparing vaccine exposure of those diagnosed with mumps and those who were not. RESULTS: There were 5683 cases of mumps recorded in the Database over the 4-year time period. As the Database represents about 5% of the UK population, we estimate that there were more than 100,000 cases of mumps diagnosed in the UK during these 4 years. The epidemic appears to have started in one practice in Wales in the first 6 months of 2003 and then spread slowly north and east, reaching a peak in 2005. Young adults aged 18-24 years were at the highest risk. There were 3 major MMR vaccination campaigns (1988-1989, 1997, and 2004-2005) that by 2006 provided more than 70% protection against mumps in children younger than 18 years of age. Protection was higher in those who had received 2 doses of the vaccine. CONCLUSION: A comprehensive program of medical information generated by selected general practitioners has provided a sound basis for the real-time recording of the origin, spread, and scope of an infectious disease.