Abstract

BackgroundAs there are few validated measures of patient safety in clinical oncology, creating an efficient measurement instrument would create significant value. Accordingly, we sought to assess the validity of a novel patient safety measure by examining the association of oncology‐specific triggers and mortality using administrative claims data.MethodsWe examined a retrospective cohort of 322 887 adult cancer patients enrolled in commercial or Medicare Advantage products for one year after an initial diagnosis of breast, colorectal, lung, or prostate cancer in 2008‐2014. We used diagnosis and procedure codes to calculate the prevalence of 16 cancer‐specific "triggers"–events that signify a potential adverse event. We compared one‐year mortality rates among patients with and without triggers by cancer type and metastatic status using logistic regression models.ResultsTrigger events affected 19% of patients and were most common among patients with metastatic colorectal (41%) and lung (50%) cancers. There was increased one‐year mortality among patients with triggers compared to patients without triggers across all cancer types in unadjusted and multivariate analyses. The increased mortality rate among patients with trigger events was particularly striking for nonmetastatic prostate cancer (1.3% vs 7.5%, adjusted odds ratio 1.96 [95% CI 1.49‐2.57]) and nonmetastatic colorectal cancer (4.1% vs 11.7%, 1.44 [1.19‐1.75]).ConclusionsThe association between adverse event triggers and poor survival among a cohort of cancer patients supports the validity of a cancer‐specific, administrative claims‐based trigger tool.

Highlights

  • Despite the complexity and potential toxicity of cancer-specific therapy, there are few high-quality studies characterizing the nature and extent of treatment-related errors and injuries in clinical oncology.[1,2,3] While toxicity assessment is deeply engrained in the cancer clinical trials tradition, much of this work seeks to identify the type and severity of adverse drug reactions inherent in novel therapies rather than injuries due to medical care that may follow a medical error or occur in a vulnerable host

  • We developed a set of oncology-specific triggers that used International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes to flag eligible cases in a large administrative database of commercial claims

  • To assess the association of event triggers with mortality, we examined the number and percent of patients with each adverse event trigger who were alive or dead at the end of a one-year period beginning with the date of the initial cancer-directed therapy, performing separate analyses by cancer type and metastatic status

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Summary

| INTRODUCTION

Despite the complexity and potential toxicity of cancer-specific therapy, there are few high-quality studies characterizing the nature and extent of treatment-related errors and injuries in clinical oncology.[1,2,3] While toxicity assessment is deeply engrained in the cancer clinical trials tradition, much of this work seeks to identify the type and severity of adverse drug reactions inherent in novel therapies rather than injuries due to medical care that may follow a medical error or occur in a vulnerable host. The PPV of the MSK triggers, using physician chart review as the gold standard, was satisfactory at 0.48 for adverse events and 0.18 for preventable events.[19,20] To extend this approach, we developed a set of oncology-specific triggers that used International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes to flag eligible cases in a large administrative database of commercial claims. We hypothesized that patients who experienced trigger events would have higher mortality rates (controlling for relevant covariates) during an initial year of cancer-directed therapy, and that the trigger-mortality association would vary by trigger, cancer type, and metastatic status

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CONFLICT OF INTEREST
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