Department of Pharmacology, Aarhus University Hospital, Aarhus, Denmark.
Department of Urology, Aarhus University Hospital, Aarhus, Denmark.
Clin Epidemiol. 2014 Oct 4;6:351-7. doi: 10.2147/CLEP.S65681. eCollection 2014.
It is well established that cancer patients have an increased risk of venous thromboembolism (VTE). However, no previous study has examined the quality of VTE diagnoses related to cancer patients in the Danish National Registry of Patients (DNRP). To support future studies on cancer and risk of VTE, this study aimed to estimate the positive predictive value (PPV) of VTE diagnoses among prostate cancer (PC) patients registered in the DNRP.
We conducted a validation study using data from hospitals within the Central Denmark Region, which covers a population of 1.3 million people. Using the DNRP, we identified a total of 120 PC patients registered with VTE within the period 1995-2012. We also identified a random sample of 120 PC patients with no VTE registration within the same period. Therefore, a total of 240 patients were selected for medical chart review. We compared data from the DNRP to data collected from medical record review (ie, reference standard). We then computed PPV, sensitivity, and specificity with corresponding 95% confidence intervals (CIs) using the Jeffreys method.
The final study sample included 232 PC patients, of which 115 were registered with VTE and 117 had no registration of VTE in the DNRP. We found the overall PPV of VTE diagnoses in the DNRP to be 86.1% (95% CI 78.9%-91.5%). Sensitivity was 98.0% (95% CI 93.8%-99.6%), and specificity was 87.8% (95% CI 81.4%-92.6%). We also found the PPV of incident PC diagnoses in the DNRP to be 98.3% (95% CI 96.1%-99.4%).
For PC patients, the registration of VTE diagnoses in the DNRP is associated with a high PPV. We provide evidence that data from the DNRP are valid for studies on risk of VTE among cancer patients.
已有研究证实癌症患者发生静脉血栓栓塞症（venous thromboembolism，VTE）的风险增加。然而，既往研究并未评估丹麦全国患者登记数据库（Danish National Registry of Patients，DNRP）中与癌症患者相关的 VTE 诊断的质量。为了支持未来有关癌症与 VTE 风险的研究，本研究旨在评估 DNRP 中登记的前列腺癌（prostate cancer，PC）患者 VTE 诊断的阳性预测值（positive predictive value，PPV）。
我们开展了一项验证研究，数据来自覆盖 130 万人口的丹麦中央大区的医院。我们利用 DNRP 识别出了 1995 年至 2012 年期间登记有 VTE 的 120 例 PC 患者。同时，我们还随机选择了同期无 VTE 登记的 120 例 PC 患者。因此，共选择了 240 例患者进行病历审查。我们将 DNRP 中的数据与病历审查（即参考标准）中收集的数据进行比较。然后，我们使用 Jeffreys 法计算了相应的 95%置信区间（confidence intervals，CI）中的 PPV、敏感性和特异性。
最终的研究样本包括 232 例 PC 患者，其中 115 例患者在 DNRP 中登记有 VTE，117 例患者无 VTE 登记。我们发现 DNRP 中 VTE 诊断的总体 PPV 为 86.1%（95%CI 78.9%-91.5%）。敏感性为 98.0%（95%CI 93.8%-99.6%），特异性为 87.8%（95%CI 81.4%-92.6%）。我们还发现 DNRP 中 PC 新发病例的 PPV 为 98.3%（95%CI 96.1%-99.4%）。
对于 PC 患者，DNRP 中 VTE 诊断的登记与高 PPV 相关。本研究为 DNRP 中有关癌症患者 VTE 风险的研究提供了有效性证据。
