Division of Clinical Pharmacology, Department of Medicine, Nashville, TN, USA.
Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):560-6. doi: 10.1002/pds.2109. Epub 2011 Mar 8.
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.
出血并发症是预防异常凝血的药物的严重不良反应。为了便于对出血并发症进行流行病学调查，我们开发并验证了一种用于与出血相关住院的自动数据库病例定义。
该病例定义利用了田纳西州医疗补助计划中 30 岁或以上的华法林相关出血正在进行的回顾性队列研究的信息。它确定了研究期间（1990 年 1 月至 2005 年 12 月）的住院治疗，这些住院治疗有诊断和/或程序表明当前有出血发作。该定义通过对 236 例住院治疗的样本进行病历审查进行了验证。
我们审查了 186 份有足够信息进行裁决的病历住院治疗。其中，165 份（89%，95%置信区间：83-92%）为临床确认的与出血相关的住院治疗。另外 19 份（10%，7-15%）被裁决为可能与出血相关。在 165 例临床确认的与出血相关的住院治疗中，自动数据库和临床定义在 163 例（99%，96-100%）中具有一致的解剖部位（胃肠道、大脑、泌尿生殖、其他）。对于那些有足够信息区分上/下消化道出血的住院治疗，上消化道部位的一致性为 89%（76-96%），下消化道部位的一致性为 91%（77-97%）。
适用于自动数据库的与出血相关住院的病例定义具有 89%至 99%的阳性预测值，并可区分特定的出血部位。
