Abstract
BackgroundThe use of real-world data to generate evidence requires careful assessment and validation of critical variables before drawing clinical conclusions. Prospective clinical trial data suggest that anatomic origin of colon cancer impacts prognosis and treatment effectiveness. As an initial step in validating this observation in routine clinical settings, we explored the feasibility and accuracy of obtaining information on tumor sidedness from electronic health records (EHR) billing codes.MethodsNine thousand four hundred three patients with metastatic colorectal cancer (mCRC) were selected from the Flatiron Health database, which is derived from de-identified EHR data. This study included a random sample of 200 mCRC patients. Tumor site data derived from International Classification of Diseases (ICD) codes were compared with data abstracted from unstructured documents in the EHR (e.g. surgical and pathology notes). Concordance was determined via observed agreement and Cohen’s kappa coefficient (κ). Accuracy of ICD codes for each tumor site (left, right, transverse) was determined by calculating the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), and corresponding 95% confidence intervals, using abstracted data as the gold standard.ResultsStudy patients had similar characteristics and side of colon distribution compared with the full mCRC dataset. The observed agreement between the ICD codes and abstracted data for tumor site for all sampled patients was 0.58 (κ = 0.41). When restricting to the 62% of patients with a side-specific ICD code, the observed agreement was 0.84 (κ = 0.79). The specificity (92–98%) of structured data for tumor location was high, with lower sensitivity (49–63%), PPV (64–92%) and NPV (72–97%). Demographic and clinical characteristics were similar between patients with specific and non-specific side of colon ICD codes.ConclusionsICD codes are a highly reliable indicator of tumor location when the specific location code is entered in the EHR. However, non-specific side of colon ICD codes are present for a sizable minority of patients, and structured data alone may not be adequate to support testing of some research hypotheses. Careful assessment of key variables is required before determining the need for clinical abstraction to supplement structured data in generating real-world evidence from EHRs.
Highlights
The use of real-world data to generate evidence requires careful assessment and validation of critical variables before drawing clinical conclusions
This study demonstrates that billing codes are a highly reliable indicator of tumor location, when the specific location code is entered in the electronic health records (EHR)
For a sizable minority of metastatic colorectal cancer (mCRC) patients, non-specific colon cancer International Classification of Diseases (ICD) codes are captured in the EHR; structured data for these patients do not indicate tumor side of colon
Summary
The use of real-world data to generate evidence requires careful assessment and validation of critical variables before drawing clinical conclusions. Given that only a small percentage of cancer patients take part in clinical research studies [1], there is increasing interest in leveraging the data contained in administrative and clinical databases for patients treated outside of clinical trials, as these data can provide guidance for treatment decisions. Such real-world data have the potential to be more representative of patients in routine practice, given that clinical trials tend to enroll highly selected patients who are younger and have fewer comorbidities. The promise of EHR data can only be realized if each data point is carefully assessed and validated before clinical conclusions are drawn
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