The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies.
Introduction: The identification of upper gastrointestinal (UGI) bleeding and perforated ulcers in claims data typically relies on inpatient diagnoses. The use of hemoglobin laboratory results might increase the detection of UGI events that do not lead to hospitalization.Objectives: Our objective wa...
| Published in: | Drug Safety Vol. 40; no. 1; pp. 91 - 101 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Springer Nature
Jan2017
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=120531049&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 120531049 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01145916 C5E jtl: Drug Safety issn: 01145916 maglogo: N pubinfo: dt: Jan2017 vid: 40 iid: 1 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 120531049 120531049 144012509 NLM27848201 120531049 10.1007/s40264-016-0472-3 NLM27848201 120531049 ppf: 91 ppct: 10 formats: tig: atl: The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies. aug: au: Patorno, Elisabetta Gagne, Joshua Lu, Christine Haynes, Kevin Sterrett, Andrew Roy, Jason Wang, Xingmei Raebel, Marsha Gagne, Joshua J Lu, Christine Y Sterrett, Andrew T Raebel, Marsha A affil: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine , Brigham and Women's Hospital and Harvard Medical School , 1620 Tremont Street (Suite 3030) Boston 02120 USA sug: subj: Antiinflammatory Agents, Non-Steroidal Adverse Effects Hemoglobins Analysis Peptic Ulcer Chemically Induced Gastrointestinal Hemorrhage Chemically Induced Gastrointestinal Hemorrhage Diagnosis Adult Adverse Drug Event Male Sentinel Event Aged Inpatients Resource Databases Coding Prospective Studies Middle Age Time Factors Female Human Adverse Drug Event Epidemiology Peptic Ulcer Diagnosis Validation Studies Comparative Studies Evaluation Research Multicenter Studies Adult: 19-44 years Aged: 65+ years Middle Aged: 45-64 years Male Female ab: Introduction: The identification of upper gastrointestinal (UGI) bleeding and perforated ulcers in claims data typically relies on inpatient diagnoses. The use of hemoglobin laboratory results might increase the detection of UGI events that do not lead to hospitalization.Objectives: Our objective was to evaluate whether hemoglobin results increase UGI outcome identification in electronic databases, using non-steroidal anti-inflammatory drugs (NSAIDs) as a test case.Methods: From three data partner sites within the Mini-Sentinel Distributed Database, we identified NSAID initiators aged ≥18 years between 2008 and 2013. Numbers of events and risks within 30 days after NSAID initiation were calculated for four mutually exclusive outcomes: (1) inpatient UGI diagnosis of bleeding or gastric ulcer (standard claims-based definition without laboratory results); (2) non-inpatient UGI diagnosis AND ≥3 g/dl hemoglobin decrease; (3) ≥3 g/dl hemoglobin decrease without UGI diagnosis in any clinical setting; (4) non-inpatient UGI diagnosis, without ≥3 g/dl hemoglobin decrease.Results: We identified 2,289,772 NSAID initiators across three sites. Overall, 45.3% had one or more hemoglobin result available within 365 days before or 30 days after NSAID initiation; only 6.8% had results before and after. Of 7637 potential outcomes identified, outcome 1 accounted for 21.7%, outcome 2 for 0.8%, outcome 3 for 34.3%, and outcome 4 for 43.3%. Potential cases identified by outcome 3 were largely not suggestive of UGI events. Outcomes 1, 2, and 4 had similar distributions of specific UGI diagnoses.Conclusions: Using available hemoglobin result values combined with non-inpatient UGI diagnoses identified few additional UGI cases. Non-inpatient UGI diagnostic codes may increase outcome detection but would require validation. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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