ABSTRACT
BACKGROUND: Single-center comparative effectiveness studies evaluating outcomes that can occur posthospitalization may become biased if outcomes diagnosed at other facilities are not ascertained. Administrative datasets that link patients' records across facilities may improve outcome ascertainment. OBJECTIVE: To determine whether use of linked administrative data significantly augments thromboembolic outcome ascertainment. RESEARCH DESIGN: Retrospective cohort study. SUBJECTS: Patients with an acute isolated calf deep vein thrombosis (DVT) diagnosed at 1 Californian center during 2010-2013. MEASURES: Proximal DVT or pulmonary embolism (PE) within 180 days. We ascertained outcomes from linked California hospitalization, emergency department, and ambulatory surgery data and compared this information to outcomes previously identified from review of the center's medical records. RESULTS: Among 384 patients with an isolated calf DVT, 333 could be linked to longitudinal administrative data records. Ten patients had a possible proximal DVT or PE (4 more clearly so) from administrative data; all were unknown from medical record review. Eleven patients with known outcomes from medical record review had no outcome from administrative data. The adjusted odds ratio of proximal DVT or PE with therapeutic anticoagulation attenuated from 0.33 [95% confidence interval (CI), 0.12-0.87] using only medical record review to 0.64 (95% CI, 0.29-1.40) using both medical record review and possible outcomes from administrative data. Restricting the outcome to diagnoses clearly involving proximal DVT or PE, the adjusted odds ratio was 0.46 (95% CI, 0.19-1.10). CONCLUSIONS: Use of linked hospital administrative data augmented detection of outcomes but imperfect linkage, nonspecific diagnoses, and documentation/coding errors introduced uncertainty regarding the accuracy of outcome ascertainment.
Subject(s)
Anticoagulants/therapeutic use , Organization and Administration/statistics & numerical data , Outcome Assessment, Health Care/standards , Venous Thromboembolism/drug therapy , Adult , Aged , California , Cohort Studies , Databases, Factual/statistics & numerical data , Female , Humans , Lower Extremity/blood supply , Lower Extremity/physiopathology , Male , Middle Aged , Odds Ratio , Outcome Assessment, Health Care/statistics & numerical data , Quality of Health Care/standards , Quality of Health Care/statistics & numerical data , Retrospective Studies , Risk Factors , Venous Thromboembolism/prevention & controlABSTRACT
IMPORTANCE: Deep vein thrombosis (DVT) isolated to the calf veins (distal to the popliteal vein) is frequently detected with duplex ultrasonography and may result in proximal thrombosis or pulmonary embolism (PE). OBJECTIVE: To evaluate whether therapeutic anticoagulation is associated with a decreased risk for proximal DVT or PE after diagnosis of an isolated calf DVT. DESIGN, SETTING, AND PARTICIPANTS: All adult patients with ultrasonographic detection of an isolated calf DVT from January 1, 2010, to December 31, 2013, at the Vascular Laboratory of the University of California, Davis, Medical Center were included. Patients already receiving therapeutic anticoagulation and those with a chronic calf DVT, a contraindication to anticoagulation, prior venous thromboembolism within 180 days, or diagnosis of a PE suspected at the time of calf DVT diagnosis were excluded. Data were analyzed from August 18, 2015, to February 14, 2016. EXPOSURES: Intention to administer therapeutic anticoagulation. MAIN OUTCOMES AND MEASURES: Proximal DVT or PE within 180 days of the diagnosis of the isolated calf DVT. RESULTS: From 14â¯056 lower-extremity venous duplex studies, we identified 697 patients with an isolated calf DVT and excluded 313 of these. The remaining 384 patients were available for analysis (222 men [57.8%]; 162 women [42.2%]; mean [SD] age, 60 [16] years). The calf DVT involved an axial vein (anterior tibial, posterior tibial, or peroneal) in 243 patients (63.2%) and a muscular branch (soleus or gastrocnemius) in 215 (56.0%). Physicians attempted to administer therapeutic anticoagulation in 243 patients (63.3%), leaving 141 control participants. Proximal DVT occurred in 7 controls (5.0%) and 4 anticoagulation recipients (1.6%); PE, in 6 controls (4.3%) and 4 anticoagulation recipients (1.6%). Therapeutic anticoagulation was associated with a decreased risk for proximal DVT or PE at 180 days (odds ratio [OR], 0.34; 95% CI, 0.14-0.83) but an increased risk for bleeding (OR, 4.35; 95% CI, 1.27-14.9), findings that persisted after adjustment for confounding factors (ORs, 0.33 [95% CI, 0.12-0.87] and 4.87 [95% CI, 1.37-17.3], respectively) and sensitivity analyses. CONCLUSIONS AND RELEVANCE: Rates of proximal DVT or PE are low after isolated calf DVT. Therapeutic anticoagulation is associated with a reduction of these outcomes but an increase in bleeding.
