Emotional Distress, Anxiety, and General Health Status in Patients With Newly Identified Small Pulmonary Nodules: Results From the Watch the Spot Trial.

BACKGROUND: Anxiety and emotional distress have not been studied in large, diverse samples of patients with pulmonary nodules. RESEARCH QUESTION: How common are anxiety and distress in patients with newly identified pulmonary nodules, and what factors are associated with these outcomes? STUDY DESIGN AND METHODS: This study surveyed participants in the Watch the Spot Trial, a large, pragmatic clinical trial of more vs less intensive strategies for radiographic surveillance of patients with small pulmonary nodules. The survey included validated instruments to measure patient-centered outcomes such as nodule-related emotional distress (Impact of Event Scale-Revised) and anxiety (Six-Item State Anxiety Inventory) 6 to 8 weeks following nodule identification. Mixed-effects models were used to compare outcomes between study arms following adjustment for potential confounders and clustering within enrollment site, while also examining a limited number of prespecified explanatory factors, including nodule size, mode of detection, type of ordering clinician, and lack of timely notification prior to contact by the study team. RESULTS: The trial enrolled 34,699 patients; 2,049 individuals completed the baseline survey (5.9%). Respondents and nonrespondents had similar demographic and nodule characteristics, although more respondents were non-Hispanic and White. Impact of Event Scale-Revised scores indicated mild, moderate, or severe distress in 32.2%, 9.4%, and 7.2% of respondents, respectively, with no difference in scores between study arms. Following adjustment, greater emotional distress was associated with larger nodule size and lack of timely notification by a clinician; distress was also associated with younger age, female sex, ever smoking, Black race, and Hispanic ethnicity. Anxiety was associated with lack of timely notification, ever smoking, and female sex. INTERPRETATION: Almost one-half of respondents experienced emotional distress 6 to 8 weeks following pulmonary nodule identification. Strategies are needed to mitigate the burden of distress, especially in younger, female, ever smoking, and minoritized patients, and those with larger nodules. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT02623712; URL: www. CLINICALTRIALS: gov.

Patient responses to passive enrollment into a large, pragmatic clinical trial: A qualitative content analysis.

BACKGROUND: While passive enrollment or "opt-out" recruitment methods facilitate pragmatic clinical trials, they pose unique challenges, and it is unclear how participants feel about them. Here, we describe patient responses to passive enrollment into the Watch the Spot Trial, a pragmatic trial comparing two sets of guidelines for small lung nodule follow-up. METHODS: For this nested qualitative study, we analyzed participant-initiated calls and emails. We performed a qualitative content analysis, using a team-coding approach to identify reasons that eligible participants contacted the study team. We calculated the proportion of contacts containing each code, and how often each code coincided with study opt-outs and other codes. RESULTS: Of 23,412 eligible participants across seven sites, 1494 (6.4%) contacted the study team, with 1560 total contacts. Among the total contacts, the most common codes (i.e., reasons for contacting the team) were study opt-outs (n = 614, 39.0%), clarification of study procedures (n = 328, 21.0%), and unawareness of the nodule prior to research notification (n = 244, 15.6%). The least common codes were concerns about sharing of protected health information with the study team (n = 22, 1.4%) or outside of the healthcare system (n = 26, 1.7%), and disapproval of the opt-out approach (n = 10, 0.6%); most patients with these concerns opted-out. Nodule unawareness sometimes coincided with anger (n = 24) or distress (n = 15), and questions about nodule care sometimes coincided with distress (n = 20) and questions about follow-up surveys (n = 26). CONCLUSION: Most participants did not report concerns about passive enrollment. Patient perspectives are an invaluable resource for minimizing risks and inconveniences of future pragmatic trials using this recruitment method.

Automated abstraction of myocardial perfusion imaging reports using natural language processing.

BACKGROUND: Findings and interpretations of myocardial perfusion imaging (MPI) studies are documented in free-text MPI reports. MPI results are essential for research, but manual review is prohibitively time consuming. This study aimed to develop and validate an automated method to abstract MPI reports. METHODS: We developed a natural language processing (NLP) algorithm to abstract MPI reports. Randomly selected reports were double-blindly reviewed by two cardiologists to validate the NLP algorithm. Secondary analyses were performed to describe patient outcomes based on abstracted-MPI results on 16,957 MPI tests from adult patients evaluated for suspected ACS. RESULTS: The NLP algorithm achieved high sensitivity (96.7%) and specificity (98.9%) on the MPI categorical results and had a similar degree of agreement compared to the physician reviewers. Patients with abnormal MPI results had higher rates of 30-day acute myocardial infarction or death compared to patients with normal results. We identified issues related to the quality of the reports that not only affect communication with referring physicians but also challenges for automated abstraction. CONCLUSION: NLP is an accurate and efficient strategy to abstract results from the free-text MPI reports. Our findings will facilitate future research to understand the benefits of MPI studies but requires validation in other settings.

Automated interpretation of stress echocardiography reports using natural language processing.

Aims: Stress echocardiography (SE) findings and interpretations are commonly documented in free-text reports. Reusing SE results requires laborious manual reviews. This study aimed to develop and validate an automated method for abstracting SE reports in a large cohort. Methods and results: This study included adult patients who had SE within 30 days of their emergency department visit for suspected acute coronary syndrome in a large integrated healthcare system. An automated natural language processing (NLP) algorithm was developed to abstract SE reports and classify overall SE results into normal, non-diagnostic, infarction, and ischaemia categories. Randomly selected reports (n = 140) were double-blindly reviewed by cardiologists to perform criterion validity of the NLP algorithm. Construct validity was tested on the entire cohort using abstracted SE data and additional clinical variables. The NLP algorithm abstracted 6346 consecutive SE reports. Cardiologists had good agreements on the overall SE results on the 140 reports: Kappa (0.83) and intraclass correlation coefficient (0.89). The NLP algorithm achieved 98.6% specificity and negative predictive value, 95.7% sensitivity, positive predictive value, and F-score on the overall SE results and near-perfect scores on ischaemia findings. The 30-day acute myocardial infarction or death outcomes were highest among patients with ischaemia (5.0%), followed by infarction (1.4%), non-diagnostic (0.8%), and normal (0.3%) results. We found substantial variations in the format and quality of SE reports, even within the same institution. Conclusions: Natural language processing is an accurate and efficient method for abstracting unstructured SE reports. This approach creates new opportunities for research, public health measures, and care improvement.

Single vs Serial Measurements of Cardiac Troponin Level in the Evaluation of Patients in the Emergency Department With Suspected Acute Myocardial Infarction.

Importance: Chest pain is among the most common reasons for emergency department (ED) presentations. However, most patients are at low risk for acute coronary syndrome (ACS), with low cardiac adverse outcomes rates. Biomarker testing with troponin levels is key in the initial assessment for ACS. Although serial troponin testing can improve the diagnosis of ACS in clinical practice, some patients deemed to be low risk are discharged after a single negative troponin test result. Objective: To report the clinical outcomes of patients discharged after a single negative troponin test result compared with patients discharged after serial troponin measurements. Design, Setting, and Participants: This is a retrospective cohort study of ED encounters from May 5, 2016, to December 1, 2017, across 15 community EDs within an integrated health care system in southern California. The study cohort includes 27 918 adult ED encounters in which patients were evaluated for suspected ACS with a HEART (history, electrocardiogram, age, risk factors, and troponin) score and an initial conventional troponin-I measurement below the level of detection (<0.02 ng/mL). Statistical analysis was performed from December 1, 2019, to December 1, 2020. Exposure: Single troponin test vs multiple troponin tests. Main Outcomes and Measures: The primary outcome was acute myocardial infarction or cardiac mortality; secondary outcomes included coronary artery bypass graft, percutaneous coronary intervention, invasive coronary angiography, and unstable angina within 30 days of discharge. A multivariable logistic regression model was performed to evaluate the association between testing strategies and clinical outcomes. Results: A total of 27 918 patient encounters (16 212 women [58.1%]; mean [SD] age, 58.7 [15.2] years) were included in the study. Of patients with an initial troponin measurement below the level of detection, 14 459 (51.8%) were discharged after a single troponin measurement, and 13 459 (48.2%) underwent serial troponin tests. After adjustment for cardiac risk factors and comorbidities, there was no statistically significant difference in the primary outcome of acute myocardial infarction or cardiac mortality within 30 days between the 2 groups (single troponin, 56 [0.4%] vs serial troponin, 52 [0.4%]; adjusted odds ratio, 1.41 [95% CI, 0.96-2.07]). Patients discharged after a single troponin test had lower rates of coronary artery bypass graft (adjusted odds ratio, 0.24 [95% CI, 0.11-0.48]) and invasive coronary angiography (adjusted odds ratio, 0.46 [95% CI, 0.38-0.56]). Conclusions and Relevance: This study suggests that patients are routinely discharged from the ED after a single negative troponin test result, and when compared with serial troponin testing, a single troponin test appears safe based on current physician decision-making, with no difference in rates of 30-day cardiac mortality and acute myocardial infarction, which are low in both groups.

Higher Emergency Physician Chest Pain Hospitalization Rates Do Not Lead to Improved Patient Outcomes.

BACKGROUND: Wide variation exists for hospital admission rates for the evaluation of possible acute coronary syndrome, but there are limited data on physician-level variation. Our aim is to describe physicians' rates of admission for suspected acute coronary syndrome and associated 30-day major adverse events. METHODS: We conducted a retrospective analysis of adult emergency department chest pain encounters from January 2016 to December 2017 across 15 community emergency departments within an integrated health system in Southern California. The unit of analysis was the Emergency physician. The primary outcome was the proportion of patients admitted/observed in the hospital. Secondary analysis described the 30-day incidence of death or acute myocardial infarction. RESULTS: Thirty-eight thousand seven hundred seventy-eight patients encounters were included among 327 managing physicians. The median number of encounters per physician was 123 (interquartile range, 82-157) with an overall admission/observation rate of 14.0%. Wide variation in individual physician admission rates were observed (unadjusted, 1.5%-68.9%) and persisted after case-mix adjustments (adjusted, 5.5%-27.8%). More clinical experience was associated with a higher likelihood of hospital care. There was no difference in 30-day death or acute myocardial infarction between high- and low-admitting physician quartiles (unadjusted, 1.70% versus 0.82% and adjusted, 1.33% versus 1.29%). CONCLUSIONS: Wide variation persists in physician-level admission rates for emergency department chest pain evaluation, even in a well-integrated health system. There was no associated benefit in 30-day death or acute myocardial infarction for patients evaluated by high-admitting physicians. This suggests an additional opportunity to investigate the safe reduction of physician-level variation in the use of hospital care.

Guidelines for the Evaluation of Pulmonary Nodules Detected Incidentally or by Screening: A Survey of Radiologist Awareness, Agreement, and Adherence From the Watch the Spot Trial.

PURPOSE: The aim of this study was to examine radiologists' beliefs about existing guidelines for pulmonary nodule evaluation. METHODS: A self-administered survey was developed to ascertain awareness of, agreement with, and adherence to published guidelines, including those from the Fleischner Society and the Lung CT Screening Reporting and Data System (Lung-RADS™). Surveys were distributed to 514 radiologists at 13 health care systems that are participating in a large, pragmatic trial of pulmonary nodule evaluation. Prespecified comparisons were made among groups defined by type of health system, years of experience, reader volume, and study arm. RESULTS: The response rate was 26.3%. Respondents were most familiar with guidelines from Fleischner (94%) and Lung-RADS (71%). For both incidental and screening-detected nodules, self-reported adherence to preferred guidelines was very high (97% and 94%, respectively), and most respondents believed that the benefits of adherence outweigh the harms (81% and 74%, respectively). Underlying evidence was thought to be high in quality by 68% of respondents for screening-detected nodules and 41% for incidental nodules. Approximately 70% of respondents believed that the frequency of recommended follow-up was "just right" for both guidelines. Radiologists who practice in nonintegrated health care systems were more likely to believe that the evidence was high in quality (79.5% versus 57.1%) and that the benefits of adherence outweigh the harms (85.1% versus 67.5%). Low-volume readers had lower awareness and self-reported adherence than higher volume readers. CONCLUSIONS: Radiologists reported high levels of familiarity and agreement with and adherence to guidelines for pulmonary nodule evaluation, but many overestimated the quality of evidence in support of the recommendations.

Effect of Using an Age-adjusted D-dimer to Assess for Pulmonary Embolism in Community Emergency Departments.

BACKGROUND: The objective of this study was to evaluate the effect of changing the laboratory-reported D-dimer reference intervals to age-adjusted reference intervals on the use of advanced chest imaging and 30-day adverse events among emergency department (ED) encounters. METHODS: A retrospective interrupted time-series analysis of ED encounters for patients > 50 years evaluated for suspected pulmonary embolism (PE) from April 2014 to April 2016. The primary outcome was use of advanced diagnostic imaging, and the secondary outcome was 30-day mortality or PE diagnosis. Secondary analyses also quantified delayed PE diagnoses pre- and postintervention. A generalized estimating equation segmented logistic regression model, adjusting for patient and facility characteristics, was used to determine changes in odds of diagnostic imaging and 30-day mortality or PE diagnoses. RESULTS: A total of 10,534 (5,153 pre- and 5,381 postimplementation) ED encounters were included. Advanced imaging was obtained in 35.9% of pre- versus 33% of postimplementation encounters. Age-adjusted D-dimer (AADD) showed a small and nonsignificant decrease in month-to-month trends of advanced chest imaging postimplementation (odds ratio [OR] = 0.98, 95% confidence interval [CI] = 0.96 to 1.00). Use of advanced imaging in patients with D-dimer values lower than 500 ng/mL fibrinogen-equivalent units (FEU) was similar in the preintervention (5.8%) and postintervention (6.8%) periods. However, imaging was obtained in 30% of patients postintervention with a D-dimer result less than AADD reference interval , but more than the historical 500 ng/mL FEU reference interval. Implementing an AADD threshold demonstrated no change in the rate of 30-day adverse events (missed PE or mortality). CONCLUSION: Changing the laboratory-reported D-dimer reference intervals for evaluation of PE was not associated with reduction in advanced chest imaging and did not increase 30-day adverse events. However, there was substantial noncompliance with the age-adjusted reference intervals in the postintervention period likely blunting the impact of this intervention.

Early Noninvasive Cardiac Testing After Emergency Department Evaluation for Suspected Acute Coronary Syndrome.

Importance: Professional guidelines recommend noninvasive cardiac testing (NIT) within 72 hours of an emergency department (ED) evaluation for suspected acute coronary syndrome. However, there is inexact evidence that this strategy reduces the risk of future death or acute myocardial infarction (MI). Objective: To evaluate the effectiveness of early NIT in reducing the risk of death or acute MI within 30 days. Design, Setting, and Participants: This retrospective, multicenter cohort study within the Kaiser Permanente Southern California integrated health care delivery system compared the effectiveness of early noninvasive cardiac testing vs no testing in patients with chest pain and in whom acute MI was ruled out who presented to an ED from January 2015 to December 2017. Patients were followed up for up to 30 days after emergency department discharge. Exposures: Noninvasive cardiac testing performed within 3 days of an ED evaluation for suspected acute coronary syndrome. Main Outcomes and Measures: The primary outcome was composite risk of death or acute MI, within 30 days of an ED discharge. Results: A total of 79 040 patients were evaluated in this study, of whom 57.7% were female. The mean (SD) age of the cohort was 57 (16) years, and 16 164 patients (21%) had completed early NIT. The absolute risk of death or MI within 30 days was low (<1%). Early NIT had the minor benefit of reducing the absolute composite risk of death or MI (0.4% [95% CI, -0.6% to -0.3%]), and, separately, of death (0.2% [95% CI, -0.2% to -0.1%]), MI (-0.3% [95% CI, -0.5% to -0.1%]), and major adverse cardiac event (-0.5% [95% CI, -0.7% to -0.3%]). The number needed to treat was 250 to avoid 1 death or MI, 500 to avoid 1 death, 333 to avoid 1 MI, and 200 to avoid 1 major adverse cardiovascular event within 30 days. Subgroup analysis revealed a number needed to treat of 14 to avoid 1 death or MI in the subset of patients with elevated troponin. Conclusions and Relevance: Early NIT was associated with a small decrease in the risk of death or MI in patients admitted to the ED with suspected acute coronary syndrome, but this clinical strategy may not be optimal for most patients given the large number needed to treat.

Automated Identification and Extraction of Exercise Treadmill Test Results.

Background Noninvasive cardiac tests, including exercise treadmill tests (ETTs), are commonly utilized in the evaluation of patients in the emergency department with suspected acute coronary syndrome. However, there are ongoing debates on their clinical utility and cost-effectiveness. It is important to be able to use ETT results for research, but manual review is prohibitively time-consuming for large studies. We developed and validated an automated method to interpret ETT results from electronic health records. To demonstrate the algorithm's utility, we tested the associations between ETT results with 30-day patient outcomes in a large population. Methods and Results A retrospective analysis of adult emergency department encounters resulting in an ETT within 30 days was performed. A set of randomly selected reports were double-blind reviewed by 2 physicians to validate a natural language processing algorithm designed to categorize ETT results into normal, ischemic, nondiagnostic, and equivocal categories. Natural language processing then searched and categorized results of 5214 ETT reports. The natural language processing algorithm achieved 96.4% sensitivity and 94.8% specificity in identifying normal versus all other categories. The rates of 30-day death or acute myocardial infarction varied (P<0.001) by categories for normal (0.08%), ischemic (1.9%), nondiagnostic (0.77%), and equivocal (0.58%) groups achieving good discrimination (C-statistic, 0.81; 95% CI, 0.7-0.92). Conclusions Natural language processing is an accurate and efficient strategy to facilitate large-scale outcome studies of noninvasive cardiac tests. We found that most patients are at low risk and have normal ETT results, while those with abnormal, nondiagnostic, or equivocal results have slightly higher risks and warrant future investigation.

Not all HEART scores are created equal: identifying "low-risk" patients at higher risk.

OBJECTIVE: We sought to identify sub-groups of "low-risk" HEART score patients (history, ECG, age, risk factors, and troponin) at elevated risk of acute myocardial infarction or death within 30 days. METHODS: We performed a secondary analysis of prospective emergency department (ED) encounters for suspected acute coronary syndrome in a large health system with low-risk HEART scores (0-5 points). Logistic regression using the 5 components of the HEART score analyzed the increase risk attributable to points from each of the 5 score components. RESULTS: Of 30,971 encounters among 28,992 unique patients, 135 (0.44%, 95% confidence interval [CI] = 0.37-0.51) experienced acute myocardial infarction or death. Risk increased for each component of the HEART score from 0 to 1 to 2 points (history, 0.4% to 0.5% to 0.6%; ECG, 0.3% to 0.7% to 0.7%; age, 0.2% to 0.3% to 0.7%; risk factors, 0.1% to 0.4% to 0.8%), except troponin, which had the highest risk with 1 point (troponin, 0.4% to 2.7% to 0.9%). Odds ratios from our regression, which adjusts for other components, showed a similar pattern (from 1 vs 0 and 2 vs 0 points, respectively: history, 1.0 and 1.8; ECG, 2.2 and 3.5; age, 1.2 and 2.1; risk factors, 2.4 and 4.2; and troponin, 6.0 and 3.6). CONCLUSION: Among "low-risk" suspected acute coronary syndrome encounters, increasing points within each of the 5 categories demonstrated small increases in risk of death or acute myocardial infarction, with the troponin and ECG components representing the largest risk increases.

Assessing American Red Cross First Aid mobile app user trends: Implications for resilience.

OBJECTIVE: Disasters have devastated communities, impacted the economy, and resulted in a significant increase in injuries. As the use of mobile technology increasingly becomes a common aspect of everyday life, it is important to understand how it can be used as a resource. The authors examined the use of American Red Cross mobile apps and aimed to characterize user trends to better understand how mobile apps can help bolster individual and community preparedness, resilience, and response efforts. DESIGN/MAIN OUTCOME MEASURES: Tornado data were obtained from the National Oceanic and Atmospheric Administration and the National Weather Service. Data for the mobile apps were provided by the American Red Cross. All data were reviewed for 2013, 2014, and three specific tornado events. Data were organized in Microsoft Excel spreadsheets and then graphed or mapped using ArcMap 10.2(™). RESULTS: Between 2013 and 2014, 1,068 tornado watches and 3,682 tornado warnings were issued. Additionally, 37,957,560 Tornado app users and 1,289,676 First Aid app users were active from 2013 to 2014. Overall, there was an increase in the use of American Red Cross mobile apps during tornado occurrences. Yet the increase does not show a consistent correlation with the number of watches and warnings issued. CONCLUSIONS: Mobile apps can be a resourceful tool. This study shows that mobile app use increases during a disaster. The findings indicate that there is potential to use mobile apps for building resilience as the apps provide information to support individuals and communities in helping before, during, and after disasters.