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Chart validation of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) administrative diagnosis codes for venous thromboembolism (VTE) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database.

ABSTRACT: The Sentinel Distributed Database (SDD) is a database of patient administrative healthcare records, derived from insurance claims and electronic health records, sponsored by the US Food and Drug Administration for evaluation of medical product outcomes. There is limited information on the validity of diagnosis codes for acute venous thromboembolism (VTE) in the SDD and administrative healthcare data more generally.In this chart validation study, we report on the positive predictive value (PPV) of inpatient administrative diagnosis codes for acute VTE-pulmonary embolism (PE) or lower-extremity or site-unspecified deep vein thrombosis (DVT)-within the SDD. As part of an assessment of thromboembolic adverse event risk following treatment with intravenous immune globulin (IGIV), charts were obtained for 75 potential VTE cases, abstracted, and physician-adjudicated.VTE status was determined for 62 potential cases. PPVs for lower-extremity DVT and/or PE were 90% (95% CI: 73-98%) for principal-position diagnoses, 80% (95% CI: 28-99%) for secondary diagnoses, and 26% (95% CI: 11-46%) for position-unspecified diagnoses (originating from physician claims associated with an inpatient stay). Average symptom onset was 1.5 days prior to hospital admission (range: 19 days prior to 4 days after admission).PPVs for principal and secondary VTE discharge diagnoses were similar to prior study estimates. Position-unspecified diagnoses were less likely to represent true acute VTE cases.

SUBMITTER: Ammann EM

PROVIDER: S-EPMC5841980 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Validation of administrative databases for cerebrovascular diseases is crucial for epidemiological, outcome, and health services research. The aim of this study was to validate ICD-9 codes for hemorrhagic or ischemic stroke in administrative databases, to use them for a comprehensive assessment of the burden of disease in terms of major outcomes, such as mortality, hospital readmissions, and use of healthcare resources. METHODS:We considered the hospital discharge abstract database of the Umbria Region (890,000 residents). Source population was represented by patients aged >18 discharged from hospital with a diagnosis of hemorrhagic or ischemic stroke between 2012 and 2014 using ICD-9-CM codes in primary position. We randomly selected and reviewed medical charts of cases and non-cases from hospitals. For case ascertainment we considered symptoms and instrumental tests reported in the medical charts. Diagnostic accuracy measures were computed using 2x2 tables. RESULTS:We reviewed 767 medical charts for cases and 78 charts for non-cases. Diagnostic accuracy measures were: subarachnoid hemorrhage: sensitivity (SE) 100% (95% CI: 97%-100%), specificity (SP) 96% (90-99), positive predictive value (PPV) 98% (93-100), negative predictive value (NPV) 100% (95-100); intracerebral hemorrhage: SE 100% (97-100), SP 98% (91-100), PPV 98% (94-100), NPV 100% (95-100); other and unspecified intracranial hemorrhage: SE 100% (97-100), SP 96% (90-99), PPV 98% (93-100), NPV 100% (95-100); ischemic stroke due to occlusion and stenosis of precerebral arteries: SE 99% (94-100), SP 66 (57-75), PPV 70% (61-77), NPV 99% (93-100); occlusion of cerebral arteries: SE 100% (97-100), SP 87% (78-93), PPV 91% (84-95), NPV 100% (95-100); acute, but ill-defined, cerebrovascular disease: SE 100% (97-100), SP 78% (69-86), PPV % 83 (75-89), NPV 100% (95-100). CONCLUSIONS:Case ascertainment for both ischemic and hemorrhagic stroke showed good or high levels of accuracy within the regional healthcare databases in Umbria. This database can confidently be employed for epidemiological, outcome, and health services research related to any type of stroke.

Project description:BackgroundAdministrative healthcare databases are useful and inexpensive tools that can provide a comprehensive assessment of the burden of diseases in terms of major outcomes, such as mortality, hospital readmissions, and use of healthcare resources. However, a crucial issue is the reliability of information gathered. The aim of this study was to validate ICD-9 codes for several major cardiovascular conditions, i.e., acute myocardial infarction (AMI), atrial fibrillation/flutter (AF), and heart failure (HF), in order to use them for epidemiological, outcome, and health services research.MethodsData from the centralised administrative database of the Umbria Region (890,000 residents, located in Central Italy) were considered. Patients with a first hospital discharge for AMI, AF/flutter, and HF, between 2012 and 2014, were identified using ICD-9-CM codes in primary position. A sample of cases and non-cases was randomly selected, and the corresponding medical charts reviewed by specifically trained investigators. For each disease, case ascertainment was based on all clinical, laboratory, and instrumental examinations available in medical charts. Sensitivity, specificity, and predictive values with 95% confidence intervals (CIs), were calculated.ResultsWe reviewed 458 medical charts, 128 for AMI, 127 for AF/flutter, 127 for HF, and 76 of non-cases for each condition. Diagnostic accuracy measures of the original discharge diagnosis were as follows. AMI: sensitivity 98% (95% CI, 94-100%), specificity 91% (95% CI, 83-97%), positive predictive value (PPV) 95% (95% CI, 89-98%), negative predictive value (NPV) 97% (95% CI, 91-100%). AF/flutter: sensitivity 95% (95% CI, 90-98%), specificity 95% (95% CI, 87-99%), PPV 97% (95% CI, 92-99%), NPV 92% (95% CI, 84-97%). HF: sensitivity 96% (95% CI, 91-99%), specificity 90% (95% CI, 81-96%), PPV 94% (95% CI, 88-97%), NPV 93% (95% CI, 85-98%).ConclusionThe case ascertainment for AMI, AF and flutter, and HF, showed a high level of accuracy (≥ 90%). The healthcare administrative database of the Umbria Region can be confidently used for epidemiological, outcome, and health services research.

Dataset Information

Chart validation of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) administrative diagnosis codes for venous thromboembolism (VTE) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database.

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