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.

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.

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.

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.

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.