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An automated database case definition for serious bleeding related to oral anticoagulant use.

ABSTRACT: Bleeding complications are a serious adverse effect of medications that prevent abnormal blood clotting. To facilitate epidemiologic investigations of bleeding complications, we developed and validated an automated database case definition for bleeding-related hospitalizations.The case definition utilized information from an in-progress retrospective cohort study of warfarin-related bleeding in Tennessee Medicaid enrollees 30 years of age or older. It identified inpatient stays during the study period of January 1990 to December 2005 with diagnoses and/or procedures that indicated a current episode of bleeding. The definition was validated by medical record review for a sample of 236 hospitalizations.We reviewed 186 hospitalizations that had medical records with sufficient information for adjudication. Of these, 165 (89%, 95%CI: 83-92%) were clinically confirmed bleeding-related hospitalizations. An additional 19 hospitalizations (10%, 7-15%) were adjudicated as possibly bleeding-related. Of the 165 clinically confirmed bleeding-related hospitalizations, the automated database and clinical definitions had concordant anatomical sites (gastrointestinal, cerebral, genitourinary, other) for 163 (99%, 96-100%). For those hospitalizations with sufficient information to distinguish between upper/lower gastrointestinal bleeding, the concordance was 89% (76-96%) for upper gastrointestinal sites and 91% (77-97%) for lower gastrointestinal sites.A case definition for bleeding-related hospitalizations suitable for automated databases had a positive predictive value of between 89% and 99% and could distinguish specific bleeding sites.

SUBMITTER: Cunningham A

PROVIDER: S-EPMC3365595 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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An automated database case definition for serious bleeding related to oral anticoagulant use.

Cunningham Andrew A Stein C Michael CM Chung Cecilia P CP Daugherty James R JR Smalley Walter E WE Ray Wayne A WA

Pharmacoepidemiology and drug safety 20110308 6

<h4>Purpose</h4>Bleeding complications are a serious adverse effect of medications that prevent abnormal blood clotting. To facilitate epidemiologic investigations of bleeding complications, we developed and validated an automated database case definition for bleeding-related hospitalizations.<h4>Methods</h4>The case definition utilized information from an in-progress retrospective cohort study of warfarin-related bleeding in Tennessee Medicaid enrollees 30 years of age or older. It identified i ...[more]

PMID: 21387461

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Project description:ObjectiveTo estimate the association between untreated, community acquired, respiratory tract infections and bleeding in oral anticoagulant users.DesignSelf-controlled case series.SettingGeneral practices in England contributing data to the Clinical Practice Research Datalink GOLD.Participants1208 adult users of warfarin or direct oral anticoagulants with a general practice or hospital admission record of a bleeding event between January 2010 and December 2019, and a general practice record of a consultation for a community acquired respiratory tract infection for which immediate antibiotics were not prescribed (that is, untreated).Main outcome measuresRelative incidence of major bleeding and clinically relevant non-major bleeding in the 0-14 days after an untreated respiratory tract infection, compared to unexposed time periods.ResultsOf 1208 study participants, 58% (n=701) were male, median age at time of first bleed was 79 years (interquartile range 72-85), with a median observation period of 2.4 years (interquartile range 1.3-3.8). 292 major bleeds occurred during unexposed time periods and 41 in the 0-14 days after consultation for a respiratory tract infection. 1003 clinically relevant non-major bleeds occurred during unexposed time periods and 81 in the 0-14 days after consultation for a respiratory tract infection. After adjustment for age, season, and calendar year, the relative incidence of major bleeding (incidence rate ratio 2.68, 95% confidence interval 1.83 to 3.93) and clinically relevant non-major bleeding (2.32, 1.82 to 2.94) increased in the 0-14 days after an untreated respiratory tract infection. Findings were robust to several sensitivity analyses and did not differ by sex or type of oral anticoagulant.ConclusionsThis study observed a greater than twofold increase in the risk of bleeding during the 0-14 days after an untreated respiratory tract infection. These findings have potential implications for how patients and clinicians manage oral anticoagulant use during an acute intercurrent illness and warrant further investigation into the potential risks and how they might be mitigated.

Project description:BackgroundThe use of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) and low stroke risk might cause more harm than benefit. Little attention has been given to address its prevalence and associated consequences. This study aimed to investigate the prescription rate of OACs, identify associated factors, and describe incident bleeding events in low-risk patients.MethodsWe included patients with a new diagnosis of AF between 1 January 2011 and 31 December 2018 having a low risk of stroke (CHA2DS2-VASc score of 0 for males and 1 for females) from Australian general practice data (MedicineInsight). Patients were classified as OAC users if there was a recorded prescription of an OAC within 60 days of AF diagnosis, and factors associated with the prescription of an OAC were assessed using logistic regression. Recorded incident bleeding events were identified within 6 months after AF diagnosis or after OAC initiation for OAC non-users and users, respectively. The risk of bleeding was compared between the two groups by adjusting their baseline differences using propensity score matching.ResultsThe study included 2810 low-risk patients (62.3% male) with a mean age of 49.3 ± 10.8 years. Of the total, 705 (25.1%) patients had a record of OAC prescription within 60 days of diagnosis of AF. Older age (odds ratio [OR] 1.03; 95% confidence interval [CI] 1.03-1.04) and diagnosis periods (2015-2016 [OR 1.46; 95% CI 1.10-1.94] and 2017-2018 [OR 1.65; 95% CI 1.17-2.23] vs. 2011-2012) were associated with higher odds of OAC initiation. Female sex (OR 0.71; 95% CI 0.59-0.85), higher bleeding risk (ORBIT score; OR 0.80; 95% CI 0.68-0.94), and higher socioeconomic index for areas (SEIFA) quintiles (SEIFA quintiles; 2 [OR 0.65; 95% CI 0.48-0.88], 3 [OR 0.74; 95% CI 0.56-0.98], 4 [OR 0.70; 95% CI 0.52-0.94], 5 [OR 0.69; 95% CI 0.52-0.91] compared with quintile 1) were associated with lower odds of OAC prescription. A total of 52 (in 1.8% of patients) incident bleeds were identified, with 18 (2.6%) among OAC users. The rate of bleeding was not significantly different between users and non-users after matching. However, within OAC users, commencement of OAC was associated with an increased risk of bleeding compared to the period before OAC initiation (p = 0.006).ConclusionsOne in four patients at low risk of stroke received an OAC within 60 days of AF diagnosis. Older age and the period following the widespread availability of direct-acting OACs were associated with an increased likelihood of OAC prescription. Positively, using OACs was not associated with an increased rate of bleeding compared to non-users.

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An automated database case definition for serious bleeding related to oral anticoagulant use.

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An automated database case definition for serious bleeding related to oral anticoagulant use.

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