Abstract and Introduction
Abstract
Objective Diagnostic errors lead to preventable hospital morbidity and mortality. ICU patients may be at particularly high risk for misdiagnosis. Little is known about misdiagnosis in pediatrics, including PICU and neonatal ICU. We sought to assess diagnostic errors in PICU and neonatal ICU settings by systematic review.
Data Sources We searched PubMed, Embase, CINAHL, and Cochrane.
Study Selection: We identified observational studies reporting autopsy-confirmed diagnostic errors in PICU or neonatal ICU using standard Goldman criteria.
Data Extraction We abstracted patient characteristics, diagnostic error description, rates and error classes using standard Goldman criteria for autopsy misdiagnoses and calculated descriptive statistics.
Data Synthesis We screened 329 citations, examined 79 full-text articles, and included 13 studies (seven PICU; six neonatal ICU). The PICU studies examined a total of 1,063 deaths and 498 autopsies. Neonatal ICU studies examined a total of 2,124 neonatal deaths and 1,259 autopsies. Major diagnostic errors were found in 19.6% of autopsied PICU and neonatal ICU deaths (class I, 4.5%; class II, 15.1%). Class I (potentially lethal) misdiagnoses in the PICU (43% infections, 37% vascular) and neonatal ICU (62% infections, 21% congenital/metabolic) differed slightly. Although missed infections were most common in both settings, missed vascular events were more common in the PICU and missed congenital conditions in the neonatal ICU.
Conclusion Diagnostic errors in PICU/neonatal ICU populations are most commonly due to infection. Further research is needed to better quantify pediatric intensive care–related misdiagnosis and to define potential strategies to reduce their frequency or mitigate misdiagnosis-related harm.
Introduction
Diagnostic errors in medicine represent a large source of preventable morbidity and mortality in hospitalized patients. It has been estimated that diagnostic error results in 40–80,000 deaths annually in the United States. ICU patients may be at significantly higher risk for diagnostic errors and thus are a population that deserves special focus.
Diagnostic errors are defined as diagnoses that are missed, wrong, or delayed, as detected by some subsequent definitive test or finding. Patient harm may result from unrecognized disease, unnecessary diagnostic testing, or inappropriate therapy. Misdiagnosis-related harm is preventable harm suffered from treatment provided for a condition not actually present, or the delay or failure to treat a condition actually present when the working diagnosis was wrong or unknown. Not all diagnostic errors result in direct harm to the patient, but may, nevertheless, result in unnecessary resource and healthcare costs.
Diagnostic errors are likely underreported and underrecognized. The majority of studies reporting diagnostic error use autopsy data as the gold standard compared with clinical data to identify missed diagnosis and diagnostic error. Autopsy-based studies typically use a Goldman classification system (Table 1). Class I errors are those that, if recognized, have the potential for direct impact on both therapy and outcome.
Although there is an emerging literature and investigations into diagnostic error in adult ICU medicine, relatively little is known about diagnostic error in pediatrics and even less is known about diagnostic error in the neonatal ICU (NICU) and PICU. It has been reported that diagnostic errors occur more frequently in patients who die in the ICU when compared with patients who die in the emergency department or in the general ward. Autopsy rates in pediatric patients have also been reported to be higher than in adult patients.
To begin to understand the burden and scope of diagnostic error in PICU and NICU patients, we performed a comprehensive search of the available literature on diagnostic error to identify studies reporting rates for PICU or NICU patients. The goal of this study was to estimate the prevalence and distribution of autopsy-confirmed diagnostic errors in PICU and NICU populations. We hypothesized that there would be limited available applicable literature. Based on a prior study of adult ICU patients, we hypothesized that most errors would be related to infection and vascular events; however, we expected a significant contribution of undiagnosed congenital and genetic-metabolic conditions in the pediatric population.