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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
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1 to 25 of 543 Research Studies DisplayedGeorgette N, Michelson K, Monuteaux M
A temperature- and age-adjusted shock index for emergency department identification of pediatric sepsis.
The objective of this retrospective cohort study was to derive a temperature- and age-adjusted mean shock index (TAMSI) for early identification of sepsis and septic shock in children with suspected infection. Researchers analyzed data on children who presented with suspected infection to a single emergency department over a 10-year period. Test characteristics for the TAMSI cutoffs were compared with those for the Pediatric Advanced Life Support (PALS) tachycardia or systolic hypotension cutoffs. The results showed that TAMSI achieved a similar negative likelihood ratio and improved positive likelihood ratio compared with PALS vital sign cutoffs for the prediction of septic shock, but did not improve on PALS for sepsis prediction among children with suspected infection.
AHRQ-funded; HS026503.
Citation: Georgette N, Michelson K, Monuteaux M .
A temperature- and age-adjusted shock index for emergency department identification of pediatric sepsis.
Ann Emerg Med 2023 Oct; 82(4):494-502. doi: 10.1016/j.annemergmed.2023.03.026..
Keywords: Children/Adolescents, Emergency Department, Sepsis, Diagnostic Safety and Quality
Gupta AB, Greene MT, Fowler KE
Associations between hospitalist shift busyness, diagnostic confidence, and resource utilization: a pilot study.
Hospitalists are frequently attending to multiple tasks when overseeing patient care, and patients are at risk for diagnostic errors. The purpose of this single-center, prospective, pilot observational study was to measure hospitalist workload and examine its influences on diagnostic performance in a real-world clinical setting. The researchers had hospitalists admitting new patients to the hospital complete an abbreviated Mindful Attention Awareness Tool and a survey on diagnostic confidence upon shift completion. Complete data were available for 37 unique hospitalists who admitted 160 unique patients. The study found that increases in admissions and pages were related with higher odds of hospitalists reporting it was "difficult to focus on what is happening in the present." Increased pages was associated with a decrease in the number of differential diagnoses listed.
AHRQ-funded; HS024385; HS025891.
Citation: Gupta AB, Greene MT, Fowler KE .
Associations between hospitalist shift busyness, diagnostic confidence, and resource utilization: a pilot study.
J Patient Saf 2023 Oct 1; 19(7):447-52. doi: 10.1097/pts.0000000000001157..
Keywords: Hospitals, Diagnostic Safety and Quality, Patient Safety
Zhu Y, Wang Z, Newman-Toker D
Misdiagnosis-related harm quantification through mixture models and harm measures.
Investigating and monitoring misdiagnosis-related harm utilizing the traditional chart review process is labor intensive, potentially unstable, and not conducive to scaling. Researchers propose to leverage the association between symptoms and diseases based on electronic health records or claim data. Specifically, the increased risk of disease after a false-negative diagnosis can be utilized as an indicator of potential harm. The researcher report that the problem with off-the-shelf statistical methods to assess these dynamics is that they do not fully accommodate the data structure of a well-hypothesized risk pattern and thus fail to sufficiently address the unique challenges. The purpose of this study was to explore a mixture regression model and its associated goodness-of-fit testing to address the existing gaps seen in usual statistical analysis methods. The researchers additionally proposed harm measures and profiling analysis procedures to quantify, assess, and compare misdiagnosis-related harm across institutes with potentially differing patient population compositions. Simulation studies were utilized to study the performance of the proposed methods. Researchers then applied and demonstrated the methods through data analyses on stroke occurrence data from the Taiwan Longitudinal Health Insurance Database. From those analyses risk factors for being harmed due to misdiagnosis were assessed, which revealed insights for health care quality research. Finally, researchers compared general and special care hospitals in Taiwan and observed better diagnostic performance in special care hospitals utilizing a variety of new assessment measures.
AHRQ-funded; HS027614.
Citation: Zhu Y, Wang Z, Newman-Toker D .
Misdiagnosis-related harm quantification through mixture models and harm measures.
Biometrics 2023 Sep; 79(3):2633-48. doi: 10.1111/biom.13759..
Keywords: Diagnostic Safety and Quality, Patient Safety, Hospitals
Murphy DR, Zimolzak AJ, Upadhyay DK
Developing electronic clinical quality measures to assess the cancer diagnostic process.
Electronic clinical quality measures (eCQMs) to evaluate quality of cancer diagnosis could facilitate quantification and improvement of diagnostic performance. The purpose of this study was to developed 2 eCQMs to evaluate diagnostic assessment of red-flag clinical findings for colorectal cancer (CRC) and lung cancer. At each site the researchers assessed 100 positive and 20 negative randomly chosen records for each eCQM at each site to validate accuracy and categorized missed opportunities associated with system, provider, or patient factors. The researchers applied the CRC eCQM at both sites, while the lung cancer eCQM was only applied at the VA due to an absence of structured data indicating level of cancer suspicion on most chest imaging results at Geisinger. The study found that for the CRC eCQM, the appropriate follow-up took place in 26, 746 out of 74, 314 patients (36.0%) in the VA after removing clinical exclusions and in 1,009 out of 2,461 patients (41.1%) at Geisinger. The appropriate assessment for lung cancer in the VA took place in 25, 166 out of 40, 924 patients (61.5). Provider factors were cited by reviewers the primary source of missed opportunities at both sites.
AHRQ-funded; HS022087.
Citation: Murphy DR, Zimolzak AJ, Upadhyay DK .
Developing electronic clinical quality measures to assess the cancer diagnostic process.
J Am Med Inform Assoc 2023 Aug 18; 30(9):1526-31. doi: 10.1093/jamia/ocad089..
Keywords: Cancer: Lung Cancer, Cancer, Quality Measures, Diagnostic Safety and Quality, Quality of Care
Tarnutzer AA, Gold D, Wang Z
Impact of clinician training background and stroke location on bedside diagnostic test accuracy in the acute vestibular syndrome - a meta-analysis.
Researchers conducted a systematic review to assess the accuracy of bedside diagnosis of acute dizziness/vertigo to differentiate peripheral vestibular from central neurologic causes. Their review indicated that the Head Impulse, Nystagmus, Test of Skew (HINTS) examination by trained clinicians can differentiate peripheral from central causes and show higher diagnostic accuracy for stroke in the first 24-48 hours than MRI diffusion-weighted imaging. They concluded that these techniques should be disseminated to clinicians evaluating dizziness/vertigo.
AHRQ-funded; HS029350.
Citation: Tarnutzer AA, Gold D, Wang Z .
Impact of clinician training background and stroke location on bedside diagnostic test accuracy in the acute vestibular syndrome - a meta-analysis.
Ann Neurol 2023 Aug; 94(2):295-308. doi: 10.1002/ana.26661..
Keywords: Diagnostic Safety and Quality, Training, Education: Continuing Medical Education, Provider: Clinician, Stroke, Cardiovascular Conditions
Liberman AL, Wang Z, Zhu Y
Optimizing measurement of misdiagnosis-related harms using Symptom-Disease Pair Analysis of Diagnostic Error (SPADE): comparison groups to maximize SPADE validity.
The purpose of this paper was to clarify features of the Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) approach to accurately measure diagnostic errors to assure that researchers utilize this method to yield valid results, as well as improve the validity of SPADE and related approaches to quantify diagnostic error in medicine. The researchers describe four types of comparators (intra-group and inter-group), detailing the reason for selecting one over the other and conclusions that can be drawn from these comparative analyses.
AHRQ-funded; HS027614.
Citation: Liberman AL, Wang Z, Zhu Y .
Optimizing measurement of misdiagnosis-related harms using Symptom-Disease Pair Analysis of Diagnostic Error (SPADE): comparison groups to maximize SPADE validity.
Diagnosis 2023 Aug 1; 10(3):225-34. doi: 10.1515/dx-2022-0130..
Keywords: Diagnostic Safety and Quality, Medical Errors, Adverse Events, Electronic Health Records (EHRs), Health Information Technology (HIT), Patient Safety
Young AL, Monuteaux MC, Cooney TM
Predictors of delayed diagnosis of pediatric CNS tumors in the emergency department.
Delays in the diagnosis of central nervous system (CNS) tumors in children may lead to adverse outcomes and undue burdens on families. The purpose of this study was to examine factors related with delayed emergency department (ED) diagnosis to identify approaches to reduce delays. Researchers included 2828 children, 76% were controls, 24% were cases). Among cases, 68% had 1 preceding ED visit, 21% had 2, and 11% had 3 or more. The study found significant predictors of delayed diagnosis included presence of a complex chronic condition, rural hospital location, nonteaching hospital status, age younger than 5 years, public insurance, and black race.
AHRQ-funded; HS026503.
Citation: Young AL, Monuteaux MC, Cooney TM .
Predictors of delayed diagnosis of pediatric CNS tumors in the emergency department.
Pediatr Emerg Care 2023 Aug; 39(8):617-22. doi: 10.1097/pec.0000000000002943..
Keywords: Children/Adolescents, Diagnostic Safety and Quality, Cancer, Emergency Department
Rao G, Ufholz K, Saroufim P
Recognition, diagnostic practices, and cancer outcomes among patients with unintentional weight loss (UWL) in primary care.
The objective of this study was to identify the incidence, rate of physician recognition, diagnostic practices, and cancer outcomes for unintentional weight loss. Researchers completed a secondary analysis of structured and unstructured EHR data collected from adult, established primary care patients with a minimum of two weight measurements in 2020 and in 2021. The results indicated that unintentional weight loss is poorly recognized across a diverse range of patients. The researchers concluded that lack of research-informed guidance may explain low rates of recognition and variability in diagnostic practices.
AHRQ-funded; HS029358.
Citation: Rao G, Ufholz K, Saroufim P .
Recognition, diagnostic practices, and cancer outcomes among patients with unintentional weight loss (UWL) in primary care.
Diagnosis 2023 Aug 1; 10(3):267-74. doi: 10.1515/dx-2023-0002..
Keywords: Cancer, Primary Care, Diagnostic Safety and Quality, Provider: Physician
Pinevich Y, Barwise AK, Austin JM
Time to diagnostic certainty for saddle pulmonary embolism in hospitalized patients.
The purpose of this retrospective observational study was to explore the concept of the time to diagnostic certainty, defined as the interval between first patient presentation and confirmed pulmonary embolism (PE) diagnosis with computed tomography pulmonary angiogram (CT PA). Participants were randomly selected adult patients admitted to academic medical centers and associated community-based hospitals in one health system with a diagnosis of acute saddle PE. Time to diagnostic certainty ranged from 1.5 to 310 hours; the median time to treatment was 3.5 hours.
AHRQ-funded; HS026609.
Citation: Pinevich Y, Barwise AK, Austin JM .
Time to diagnostic certainty for saddle pulmonary embolism in hospitalized patients.
Biomol Biomed 2023 Jul 3; 23(4):671-79. doi: 10.17305/bb.2022.8393..
Keywords: Diagnostic Safety and Quality, Blood Clots
Michelson KA, McGarghan FLE, Waltzman ML
Community validation of an approach to detect delayed diagnosis of appendicitis in big databases.
This study’s goal was to further validate a trigger tool that has been used in community emergency departments (EDs) to detect delayed diagnosis of pediatric appendicitis. The authors studied patients <21 years old diagnosed with appendicitis from 2008 to 2019 in 8 eastern Massachusetts EDs. Eligible patients had 2 ED encounters within 7 days, the second time ending with an appendicitis diagnosis. Trained reviewers evaluated medical records that showed delayed diagnosis. The previously validated trigger tool was applied to participants’ electronic medical record data, with the tool assigning a probability of delayed diagnosis for each patient. Four confidence thresholds were determined, and the area under the receiver operating curve was calculated. The authors analyzed 68 children with 2 encounters leading to a diagnosis of appendicitis (i.e., possible delay). A delayed diagnosis prediction was assigned to patients at 4 thresholds of confidence (>0%, >50%, >75%, and >90% confident), the positive predictive values were respectively 74%, 89%, 92%, and 89%; the negative predictive values were respectively 100%, 57%, 50%, and 33%. The area under the receiver operating curve was 0.837.
AHRQ-funded; HS026503.
Citation: Michelson KA, McGarghan FLE, Waltzman ML .
Community validation of an approach to detect delayed diagnosis of appendicitis in big databases.
Hosp Pediatr 2023 Jul; 13(7):e170-e74. doi: 10.1542/hpeds.2023-007204..
Keywords: Children/Adolescents, Diagnostic Safety and Quality
Garber A, Garabedian P, Wu L
Developing, pilot testing, and refining requirements for 3 EHR-integrated interventions to improve diagnostic safety in acute care: a user-centered approach.
This study’s objective was to describe a user-centered approach to develop, pilot test, and refine requirements for 3 electronic health record (EHR)-integrated interventions that target key diagnostic process failures in hospitalized patients. The interventions to be developed were a Diagnostic Safety Column (DSC) within an EHR-integrated dashboard to identify at-risk patients; a Diagnostic Time-Out (DTO) for clinicians to reassess the working diagnosis; and a Patient Diagnosis Questionnaire (PDQ) to gather patient concerns about the diagnostic process. After initial refinement from an analysis, final requirements were created for 10 test cases predicted by the DSC, 18 clinician DTO participants, and 39 PDQ responses including the following: DSC configurable parameters (variables, weights) to adjust baseline risk estimates in real-time based on new clinical data collected during hospitalization; more concise DTO wording and flexibility for clinicians to conduct the DTO with or without the patient present; and integration of PDQ responses into the DSC to ensure closed-looped communication with clinicians. An analysis of focus groups confirmed that tight integration of the interventions with the EHR would be necessary to prompt clinicians to reconsider the working diagnosis in cases with elevated diagnostic error (DE) risk or uncertainty. Potential implementation barriers identified included alert fatigue and distrust of the risk algorithm (DSC); time constraints, redundancies, and concerns about disclosing uncertainty to patients (DTO); and patient disagreement with the care team's diagnosis (PDQ).
AHRQ-funded; HS026613.
Citation: Garber A, Garabedian P, Wu L .
Developing, pilot testing, and refining requirements for 3 EHR-integrated interventions to improve diagnostic safety in acute care: a user-centered approach.
JAMIA Open 2023 Jul; 6(2):ooad031. doi: 10.1093/jamiaopen/ooad031..
Keywords: Electronic Health Records (EHRs), Health Information Technology (HIT), Diagnostic Safety and Quality, Patient Safety
Bradford A, Goeschel C, Shofer M
Five new ways to advance diagnostic safety in your clinical practice.
This AHRQ-authored article describes new resources that clinicians can use to advance diagnostic safety and prevent errors. The new AHRQ-funded resources include Calibrate Dx, Measure Dx, Safer Dx Checklist, TeamSTEPPS for Diagnostic Improvements, and the Toolkit for Engaging Patients to Improve Diagnostic Safety. A table is provided which describes the resource, gives an example or strategy or practice change, and describes the audience for the resource. Recommendations are also given to help clinicians reduce barriers to diagnostic safety including: 1) Start small and focused; 2) Align with other high-priority initiatives; 3) Start with the resources you have; and 4) Consider how diagnostic safety work can enhance missions other than clinical care.
AHRQ-authored.
Citation: Bradford A, Goeschel C, Shofer M .
Five new ways to advance diagnostic safety in your clinical practice.
Am Fam Physician 2023 Jul; 108(1):14-16..
Keywords: Diagnostic Safety and Quality, Patient Safety
Congdon M, Rauch B, Carroll B
Opportunities for diagnostic improvement among pediatric hospital readmissions.
The purpose of this retrospective cohort study was to: 1) identify and describe diagnostic errors, termed "missed opportunities for improving diagnosis" (MOIDs) in general pediatric patients who experienced hospital readmission, 2) outline improvement opportunities, and 3) explore factors associated with increased risk of MOID. The researchers included unplanned readmissions within 15 days of discharge from a freestanding children's hospital between October 2018 and September 2020. Health records were reviewed and discussed by practicing inpatient physicians to identify MOIDs using SaferDx, an established instrument. MOIDs were evaluated using a diagnostic-specific tool to identify improvement opportunities within the diagnostic process. The study found that MOIDs were identified in 6.3% of 348 readmissions. Opportunities for improvement included: delay in considering the correct diagnosis (50%) and failure to order needed test (45%). Patients with MOIDs were older than patients without MOIDs but similar in gender, primary language, race, ethnicity, and insurance type. The researchers did not identify conditions related with higher risk of MOID. Lower respiratory tract infections accounted for 26% of admission diagnoses but only 1 (4.5%) case of MOID.
AHRQ-funded; HS028682.
Citation: Congdon M, Rauch B, Carroll B .
Opportunities for diagnostic improvement among pediatric hospital readmissions.
Hosp Pediatr 2023 Jul; 13(7):563-71. doi: 10.1542/hpeds.2023-007157..
Keywords: Children/Adolescents, Diagnostic Safety and Quality, Hospitals, Hospital Readmissions
Michelson KA, Bachur RG, Grubenhoff JA
Outcomes of missed diagnosis of pediatric appendicitis, new-onset diabetic ketoacidosis, and sepsis in five pediatric hospitals.
This study’s objective was to determine 90-day complication rates and hospital utilization after a missed diagnosis of pediatric appendicitis, new-onset diabetic ketoacidosis (DKA), or sepsis. The authors evaluated patients under 21 years of age visiting five pediatric emergency departments (EDs) with a study condition. Case patients included had a preceding ED visit within 7 days of diagnosis and underwent case review to confirm a missed diagnosis. The authors compared complication rates and utilization between case and control patients after adjusting for age, sex, and insurance. They analyzed 29,398 children with appendicitis, 5366 with DKA, and 3622 with sepsis, of whom 429, 33, and 46, respectively, had a missed diagnosis. Patients with a missed appendicitis or DKA diagnosis had more hospital days and readmissions, but there were no significant differences for those with sepsis. Those with missed appendicitis were more likely to have abdominal abscess drainage or perforated appendicitis. Those with missed DKA were more likely to have cerebral edema, mechanical ventilation, or death. Those with missed sepsis were less likely to have mechanical ventilation.
AHRQ-funded; HS026503.
Citation: Michelson KA, Bachur RG, Grubenhoff JA .
Outcomes of missed diagnosis of pediatric appendicitis, new-onset diabetic ketoacidosis, and sepsis in five pediatric hospitals.
J Emerg Med 2023 Jul; 65(1):e9-e18. doi: 10.1016/j.jemermed.2023.04.006..
Keywords: Children/Adolescents, Sepsis, Diabetes, Diagnostic Safety and Quality
Mehta SD, Congdo M, Phillips CA
Opportunities to improve diagnosis in emergency transfers to the pediatric intensive care unit.
This study’s objective was to apply diagnostic process improvement frameworks to identify missed opportunities for improvement in diagnosis (MOID) in pediatric emergency transfers (ETs) and evaluate their association with outcomes. ET is defined as hospitalized patients who require ICU interventions within 1 hour of ICU transfer, which is a proximal measure of late recognition associated with increased mortality and length of stay (LOS). This single-center retrospective cohort study was conducted from January 2015 to June 2019. Primary outcome was the presence of missed opportunities for improvement in diagnosis (MOID), determined using SaferDx. MOID was identified in 37 of 129 ETs (29%). Cases with MOID differed in originating service, but not demographically, with failure to recognize urgency of an identified condition the most common diagnostic process opportunity. ET cases with MOID had higher odds of mortality and longer post-transfer LOS.
AHRQ-funded; HS028682.
Citation: Mehta SD, Congdo M, Phillips CA .
Opportunities to improve diagnosis in emergency transfers to the pediatric intensive care unit.
J Hosp Med 2023 Jun; 18(6):509-18. doi: 10.1002/jhm.13103..
Keywords: Children/Adolescents, Diagnostic Safety and Quality, Intensive Care Unit (ICU)
Auerbach AD, Astik GJ, O'Leary KJ
Prevalence and causes of diagnostic errors in hospitalized patients under investigation for COVID-19.
During the COVID-19 pandemic, clinicians were required to address a disease with continuously changing traits while simultaneously complying with changes in care (e.g., physical distancing) that could contribute to diagnostic errors (DEs). The purpose of this study was to examine the frequency of DEs and their causes in patients hospitalized under investigation (PUI) for COVID-19. The researchers randomly selected up to 8 cases per site per month for evaluation, with each case evaluated by two clinicians to determine whether a DE occurred, and whether any diagnostic process faults took place. The study found that wo hundred and fifty-seven patient charts were evaluated, of which 14% contained a DE. Patients with and without DE were statistically similar in socioeconomic factors, comorbidities, risk factors for COVID-19, and COVID-19 test turnaround time and eventual positivity. The most common diagnostic process issues contributing to DE were problems with clinical assessment, testing choices, history taking, and physical examination. Diagnostic process issues related with COVID-19 policies and procedures were not related with DE risk. 35.9% of patients with errors and 5.4% of patients overall suffered harm or death due to diagnostic error.
AHRQ-funded; HS027369.
Citation: Auerbach AD, Astik GJ, O'Leary KJ .
Prevalence and causes of diagnostic errors in hospitalized patients under investigation for COVID-19.
J Gen Intern Med 2023 Jun; 38(8):1902-10. doi: 10.1007/s11606-023-08176-6..
Keywords: COVID-19, Diagnostic Safety and Quality, Hospitals, Inpatient Care, Quality of Care
Michelson KA, McGarghan FLE, Patterson EE
Clinician factors associated with delayed diagnosis of appendicitis.
The purpose of this study was to assess the relationship of clinician demographics and practice patterns with delayed appendicitis diagnosis. The researchers included children presenting with appendicitis at 13 regional emergency departments (EDs), screening patients for delayed diagnosis through a chart review for a previous ED visit within 7 days. The study found that among 7,452 children with appendicitis, 1.4% (105) had delayed diagnosis. Clinicians who used more blood tests in their general practice had a lower risk of delayed diagnosis of appendicitis. Clinicians' specialty, gender, rates of imaging, and experience were not related with delayed diagnosis.
AHRQ-funded; HS026503.
Citation: Michelson KA, McGarghan FLE, Patterson EE .
Clinician factors associated with delayed diagnosis of appendicitis.
Diagnosis 2023 May; 10(2):183-86. doi: 10.1515/dx-2022-0119..
Keywords: Children/Adolescents, Diagnostic Safety and Quality, Emergency Department
Petragallo R, Bertram P, Halvorsen P
Development and multi-institutional validation of a convolutional neural network to detect vertebral body mis-alignments in 2D x-ray setup images.
In image-guided radiotherapy (IGRT), lack of correct alignment to the vertebral body continues to be a rare but serious risk to patient safety. The researchers propose that an automated image-review algorithm be included in the IGRT process as an interlock to detect off-by-one vertebral body errors. The purpose of this study was to describe the development and validation of a convolutional neural network (CNN)-based approach for an automated image-review algorithm using patient image data from a planar stereoscopic x-ray IGRT system. The researchers collected X-rays and digitally reconstructed radiographs (DRRs) from 429 spine radiotherapy patients treated using a stereoscopic x-ray image guidance system. True-negative, "no-error" cases were established using clinically-applied, physician approved alignments. "Off-by-one vertebral body" errors were simulated by translating DRRs along the spinal column using a semi-automated method. A leave-one-institution-out method was utilized to estimate the accuracy of the model on data from unseen institutions as follows: every image from five of the institutions was used to train a CNN model from scratch. The size of the resulting training set ranged from 5700 to 9372 images, and was dependent on which five institutions had contributed data. The training set was randomized and split using a 75/25 split into the final training/ validation sets. X-ray/ DRR image pairs and the related labels of "no-error" or "shift" were used as the model input. Accuracy of the model was assessed utilizing images from the sixth institution, which was omitted from the training phase. This test set ranged from 180 to 3852 images, again depending on which institution had been left out of the training phase. The trained model was utilized to categorize the images from the test set as either "no-error" or "shifted", and the model predictions were compared to the ground truth labels to evaluate model accuracy. This process was repeated until the images of each institution had been utilized as the testing dataset. The study found that when the six models were utilized to categorize unseen image pairs from the institution omitted during training, the resulting receiver operating characteristic area under the curve values ranged from 0.976 to 0.998.
AHRQ-funded; HS026486.
Citation: Petragallo R, Bertram P, Halvorsen P .
Development and multi-institutional validation of a convolutional neural network to detect vertebral body mis-alignments in 2D x-ray setup images.
Med Phys 2023 May; 50(5):2662-71. doi: 10.1002/mp.16359..
Keywords: Imaging, Patient Safety, Diagnostic Safety and Quality
Dhudasia MB, Benitz WE, Flannery DD
Diagnostic performance and patient outcomes with c-reactive protein use in early-onset sepsis evaluations.
This study’s objective was to determine performance of C-reactive protein (CRP) in the diagnosis of early-onset sepsis, and to assess patient outcomes with and without routine use of CRP in infants in the neonatal intensive care unit (NICU). This retrospective cohort study looked at infants admitted to 2 NICUs from 2009 to 2014. During the time period, 10,134 infants were admitted, 89.9% had CRP, and 74.5% had blood culture obtained within 3 days of birth. CRP obtained plus/minus 4 hours had a sensitivity of 41.7%, specificity 89.9%, and positive likelihood ratio 4.12 in diagnosis of early-onset sepsis. When obtained 24-72 hours after blood culture, sensitivity of CRP increased significantly (89.5%), but specificity (55.7%) and positive likelihood ratio (2.02) decreased. Comparing the periods with (n = 4977) and without (n = 5135) routine use of CRP, the authors observed lower rates of early-onset sepsis evaluation (74.5% vs 50.5%), antibiotic initiation (65.0% vs 50.8%), and antibiotic prolongation in the absence of early-onset sepsis (17.3% vs 7.2%) in the later period.
AHRQ-funded; HS027468.
Citation: Dhudasia MB, Benitz WE, Flannery DD .
Diagnostic performance and patient outcomes with c-reactive protein use in early-onset sepsis evaluations.
J Pediatr 2023 May; 256:98-104.e6. doi: 10.1016/j.jpeds.2022.12.007..
Keywords: Newborns/Infants, Sepsis, Diagnostic Safety and Quality
Le P, Payne JY, Zhang L
Disease state transition probabilities across the spectrum of NAFLD: a systematic review and meta-analysis of paired biopsy or imaging studies.
This paper is a meta-analysis that summarized the rates of progression to and regression of nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), and fibrosis in adults with nonalcoholic fatty liver disease (NAFLD). PubMed/MEDLINE and 4 other databases were searched from 1985 to 2020. The authors included observational studies and randomized controlled trials in any language that used liver biopsy or imaging to diagnose NAFLD in adults with a follow-up period of ≥48 weeks. They screened 9744 articles and included 54 studies involving 26,738 patients. Among observational studies, 20% of healthy adults developed NAFL while 21% of people with fatty liver had resolution of NAFL after a median of approximately 4.5 years. In addition, 31% of patients developed NASH after 4.7 years, whereas in 29% of those with NASH, resolution occurred after a median of 3.5 years. Fibrosis stages range from F0 to F3, and time to progression by 1 fibrosis stage was 9.9, 10.3, 13.3, and 22.2 years for F0, F1, F2, and F3, respectively. In reverse, time to regress by 1 stage was 21.3, 12.5, 20.4, and 40.0 years for F4, F3, F2, and F1, respectively.
AHRQ-funded; HS026937.
Citation: Le P, Payne JY, Zhang L .
Disease state transition probabilities across the spectrum of NAFLD: a systematic review and meta-analysis of paired biopsy or imaging studies.
Clin Gastroenterol Hepatol 2023 May; 21(5):1154-68. doi: 10.1016/j.cgh.2022.07.033..
Keywords: Imaging, Diagnostic Safety and Quality
Sloane JF, Donkin C, Newell BR
Managing interruptions to improve diagnostic decision-making: strategies and recommended research agenda.
This article presented a modified model of interruptions to visualize the interruption process and to illustrate where potential interventions could be implemented. The authors considered empirically tested strategies from health care and cognitive psychology to lay the groundwork for additional research to mitigate effects of interruptions during diagnostic decision-making. Strategies to minimize the negative impacts of interruptions as well as strategies to prevent interruptions were highlighted, and the authors built upon these strategies to propose research priorities within the field of diagnostic safety.
AHRQ-funded; 233201500022I.
Citation: Sloane JF, Donkin C, Newell BR .
Managing interruptions to improve diagnostic decision-making: strategies and recommended research agenda.
J Gen Intern Med 2023 May; 38(6):1526-31. doi: 10.1007/s11606-022-08019-w..
Keywords: Diagnostic Safety and Quality, Decision Making
Prasad PA, Correia J, Fang MC
Performance of point-of-care severity scores to predict prognosis in patients admitted through the emergency department with COVID-19.
The purpose of this study was to determine whether sepsis risk stratification scores can predict poor outcomes among hospitalized COVID-19 patients. The researchers retrospectively evaluated a cohort of adults presenting with COVID-19 to 156 Hospital Corporation of America (HCA) Healthcare emergency departments (Eds) from March 2, 2020, to February 11, 2021. The study administered the Quick Sequential Organ Failure Assessment (qSOFA), Shock Index, National Early Warning System-2 (NEWS2), and quick COVID-19 Severity Index (qCSI) at patient presentation. The primary outcome was in-hospital mortality, and secondary outcomes included intensive care unit (ICU) admission, mechanical ventilation, and vasopressors receipt. The study identified 90,376 patients with community-acquired COVID-19. 17.2% of patients died in-hospital, 28.6% went to the ICU, 13.7% received mechanical ventilation, and 13.6% received vasopressors. There were 3.8% qSOFA-positive, 45.1% Shock Index-positive, 49.8% NEWS2-positive, and 37.6% qCSI-positive at ED-triage. NEWS2 exhibited the highest AUROC for in-hospital mortality, followed by ICU admission, mechanical ventilation, and vasopressor receipt. The researchers concluded that sepsis severity scores at presentation have low discriminative power to predict outcomes in COVID-19 patients and are not reliable for clinical use.
AHRQ-funded; HS027369.
Citation: Prasad PA, Correia J, Fang MC .
Performance of point-of-care severity scores to predict prognosis in patients admitted through the emergency department with COVID-19.
J Hosp Med 2023 May; 18(5):413-23. doi: 10.1002/jhm.13106..
Keywords: COVID-19, Emergency Department, Diagnostic Safety and Quality
Krevat SA, Samuel S, Boxley C
Identifying electronic health record contributions to diagnostic error in ambulatory settings through legal claims analysis.
The purpose of this study was to evaluate legal claims data to assess whether there is a relationship between problems with electronic health records and diagnostic errors. The researchers also explored specific types of errors that took place and at which point in the diagnostic process the errors occurred.
AHRQ-funded; HS027119.
Citation: Krevat SA, Samuel S, Boxley C .
Identifying electronic health record contributions to diagnostic error in ambulatory settings through legal claims analysis.
JAMA Netw Open 2023 Apr 3; 6(4):e238399. doi: 10.1001/jamanetworkopen.2023.8399..
Keywords: Electronic Health Records (EHRs), Health Information Technology (HIT), Diagnostic Safety and Quality
Bell SK, Dong ZJ, Desroches CM
Partnering with patients and families living with chronic conditions to coproduce diagnostic safety through OurDX: a previsit online engagement tool.
Involving patients and their families in the diagnostic process is crucial, but there is a lack of methods for consistent engagement. The implementation of policies providing patients with access to electronic health records offers new possibilities. The researchers evaluated a novel online tool ("OurDX"), co-created with patients and families, to examine the nature and frequency of potential safety issues identified by patients and their families with chronic health conditions and whether these insights were incorporated into visit notes. At two US healthcare facilities, patients and their families were encouraged to participate via an online pre-visit questionnaire, which covered: (1) visit priorities, (2) recent medical history and symptoms, and (3) potential diagnostic concerns. Two physicians assessed patient-reported diagnostic issues to validate and classify diagnostic safety opportunities (DSOs). The researchers performed a chart review to determine if patient inputs were integrated into the visit note. Descriptive statistics were employed to report implementation outcomes, DSO verification, and chart review findings. The study found that OurDX reports were completed in 7075 of 18,129 (39%) eligible pediatric subspecialty visits (site 1) and 460 of 706 (65%) eligible adult primary care visits (site 2). Of the patients expressing diagnostic concerns, 63% were confirmed as probable DSOs. Overall, 7.5% of pediatric and adult patients and their families with chronic health conditions identified probable DSOs. The most frequent DSO types included patients and families feeling unheard; issues or delays in tests or referrals; and complications or delays in clarification or subsequent steps. The chart review revealed that most clinician notes incorporated all or some of the patient or family priorities and patient-reported histories.
AHRQ-funded; HS027367
Citation: Bell SK, Dong ZJ, Desroches CM .
Partnering with patients and families living with chronic conditions to coproduce diagnostic safety through OurDX: a previsit online engagement tool.
J Am Med Inform Assoc 2023 Mar 16;30(4):692-702. doi: 10.1093/jamia/ocad003.
Keywords: Chronic Conditions, Diagnostic Safety and Quality, Health Information Technology (HIT), Patient and Family Engagement, Healthcare Delivery
Tabatneck ME, He W, Lamb GS
Interferon gamma release asssay results and testing trends among patients younger than 2 years old at two US health centers.
Researchers performed a retrospective cohort study of interferon-gamma release assay (IGRA) use for the diagnosis of tuberculosis infection in patients under 2 years old in two large Boston healthcare systems. A total of 321 IGRA results were analyzed; over 90 percent were valid. The proportion of invalid/indeterminate results was found to be significantly higher among immunocompromised patients. The researchers concluded that the high proportion of valid IGRA test results in patients less than 2 years of age in a low TB prevalence setting supported the adoption of IGRAs for this age group in certain clinical scenarios. They note that the interpretation of IGRAs, particularly in immunocompromised patients, should consider the broader clinical context.
AHRQ-funded; HS000063.
Citation: Tabatneck ME, He W, Lamb GS .
Interferon gamma release asssay results and testing trends among patients younger than 2 years old at two US health centers.
Pediatr Infect Dis J 2023 Mar; 42(3):189-94. doi: 10.1097/inf.0000000000003794..
Keywords: Newborns/Infants, Diagnostic Safety and Quality, Infectious Diseases
