QUESTION ASKED: Although patient safety is a priority in oncology, few tools measure adverse events (AEs) beyond treatment-related toxicities. AEs refer to unwarranted outcomes resulting from medical care rather than the patients' underlying disease or condition. A comprehensive understanding of AEs is important to quantify the harm experienced by patients with cancer and to identify opportunities for harm prevention. The study objective was to assemble a set of clinical triggers in the medical record and assess the extent to which triggered events identified AEs. SUMMARY ANSWER:We identified a large number of triggers and potential AEs in this longitudinal cohort of patients with cancer. Some of these AEs may be targets for prevention or harm reduction. This tool offers a more efficient approach than traditional chart review and may complement the toxicityoriented tools in routine use (eg, the Common Toxicity Criteria). Our oncology-specific AE screening tool is the first effort, to our knowledge, to develop a medical record-based screening tool that is relevant across inpatient and outpatient oncology settings. WHAT WE DID:We performed a retrospective cohort study to assess the performance of an oncology medical record screening tool at a comprehensive cancer center. The study cohort included 400 patients age 18 years or older diagnosed with breast (n = 128), colorectal (n = 136), or lung cancer (n = 136), observed as in-and outpatients for up to 1 year. The oncology tool that we developed as part of the Cancer Harm (CHARM) study included 76 distinct triggers, or readily identifiable clinical indicators of potential AEs. WHAT WE FOUND:We identified 790 triggers, or 1.98 triggers per patient (range, zero to 18 triggers). Three hundred four unique AEs were identified from medical record reviews and existing AE databases. The overall positive predictive value (PPV) of the original tool was 0.40 for total AEs and 0.15 for preventable or mitigable AEs. Examples of high-performing triggers included return to the operating room or interventional radiology within 30 days of surgery (PPV, 0.88 and 0.38 for total and preventable or mitigable AEs, respectively) and elevated blood glucose (. 250 mg/dL; PPV, 0.47 and 0.40 for total and preventable or mitigable AEs, respectively). The final modified tool included 49 triggers, with an overall PPV of 0.48 for total AEs and 0.18 for preventable or mitigable AEs. BIAS, CONFOUNDING FACTOR(S), REAL-LIFE IMPLICATIONS:A valid medical record screening tool for AEs in oncology could offer a powerful new method for measuring and improving cancer care quality. Future improvements could optimize the tool's efficiency by creating automated electronic triggers for use in real-time AE detection and mitigation algorithms. It can also lead to more structured AE reporting toward this goal. Our oncology tool offers enhanced AE measurement in oncology, a step toward improving patient outcomes. Abstract PurposeAlthough patient safety is a priority in oncology, few tools measure adverse events ...
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