Sudden Cardiac Death in National Collegiate Athletic Association Athletes: A 20-Year Study.

BACKGROUND: Understanding the incidence, causes, and trends of sudden cardiac death (SCD) among young competitive athletes is critical to inform preventive policies. METHODS: This study included National Collegiate Athletic Association athlete deaths during a 20-year time frame (July 1, 2002, through June 30, 2022). Athlete deaths were identified through 4 separate independent databases and search strategies (National Collegiate Athletic Association resolutions list, Parent Heart Watch database and media reports, National Center for Catastrophic Sports Injury Research database, and insurance claims). Autopsy reports and medical history were reviewed by an expert panel to adjudicate causes of SCD. RESULTS: A total of 143 SCD cases in National Collegiate Athletic Association athletes were identified from 1102 total deaths. The National Collegiate Athletic Association resolutions list identified 117 of 143 (82%), the Parent Heart Watch database or media reports identified 89 of 143 (62%), the National Center for Catastrophic Sports Injury Research database identified 63 of 143 (44%), and insurance claims identified 27 of 143 (19%) SCD cases. The overall incidence of SCD was 1:63 682 athlete-years (95% CI, 1:54 065-1:75 010). Incidence was higher in male athletes than in female athletes (1:43 348 [95% CI, 1:36 228-1:51 867] versus 1:164 504 [95% CI, 1:110 552-1:244 787] athlete-years, respectively) and Black athletes compared with White athletes (1:26 704 [1:20 417-1:34 925] versus 1:74 581 [1:60 247-1:92 326] athlete-years, respectively). The highest incidence of SCD was among Division I male basketball players (1:8188 [White, 1:5848; Black, 1:7696 athlete-years]). The incidence rate for SCD decreased over the study period (5-year incidence rate ratio, 0.71 [95% CI, 0.61-0.82]), whereas the rate of noncardiovascular deaths remained stable (5-year incidence rate ratio, 0.98 [95% CI, 0.94-1.04]). Autopsy-negative sudden unexplained death (19.5%) was the most common postmortem examination finding, followed by idiopathic left ventricular hypertrophy or possible cardiomyopathy (16.9%) and hypertrophic cardiomyopathy (12.7%), in cases with enough information for adjudication (118 of 143). Eight cases of death were attributable to myocarditis over the study period (1 case from January 1, 2020, through June 30, 2022), with none attributed to COVID-19 infection. SCD events were exertional in 50% of cases. Exertional SCD was more common among those with coronary artery anomalies (100%) and arrhythmogenic cardiomyopathy (83%). CONCLUSIONS: The incidence of SCD in college athletes has decreased. Male sex, Black race, and basketball are associated with a higher incidence of SCD.

Symptoms and signs of lung cancer prior to diagnosis: case-control study using electronic health records from ambulatory care within a large US-based tertiary care centre.

OBJECTIVE: Lung cancer is the most common cause of cancer-related death in the USA. While most patients are diagnosed following symptomatic presentation, no studies have compared symptoms and physical examination signs at or prior to diagnosis from electronic health records (EHRs) in the USA. We aimed to identify symptoms and signs in patients prior to diagnosis in EHR data. DESIGN: Case-control study. SETTING: Ambulatory care clinics at a large tertiary care academic health centre in the USA. PARTICIPANTS, OUTCOMES: We studied 698 primary lung cancer cases in adults diagnosed between 1 January 2012 and 31 December 2019, and 6841 controls matched by age, sex, smoking status and type of clinic. Coded and free-text data from the EHR were extracted from 2 years prior to diagnosis date for cases and index date for controls. Univariate and multivariable conditional logistic regression were used to identify symptoms and signs associated with lung cancer at time of diagnosis, and 1, 3, 6 and 12 months before the diagnosis/index dates. RESULTS: Eleven symptoms and signs recorded during the study period were associated with a significantly higher chance of being a lung cancer case in multivariable analyses. Of these, seven were significantly associated with lung cancer 6 months prior to diagnosis: haemoptysis (OR 3.2, 95% CI 1.9 to 5.3), cough (OR 3.1, 95% CI 2.4 to 4.0), chest crackles or wheeze (OR 3.1, 95% CI 2.3 to 4.1), bone pain (OR 2.7, 95% CI 2.1 to 3.6), back pain (OR 2.5, 95% CI 1.9 to 3.2), weight loss (OR 2.1, 95% CI 1.5 to 2.8) and fatigue (OR 1.6, 95% CI 1.3 to 2.1). CONCLUSIONS: Patients diagnosed with lung cancer appear to have symptoms and signs recorded in the EHR that distinguish them from similar matched patients in ambulatory care, often 6 months or more before diagnosis. These findings suggest opportunities to improve the diagnostic process for lung cancer.

How Timely Is Diagnosis of Lung Cancer? Cohort Study of Individuals with Lung Cancer Presenting in Ambulatory Care in the United States.

The diagnosis of lung cancer in ambulatory settings is often challenging due to non-specific clinical presentation, but there are currently no clinical quality measures (CQMs) in the United States used to identify areas for practice improvement in diagnosis. We describe the pre-diagnostic time intervals among a retrospective cohort of 711 patients identified with primary lung cancer from 2012-2019 from ambulatory care clinics in Seattle, Washington USA. Electronic health record data were extracted for two years prior to diagnosis, and Natural Language Processing (NLP) applied to identify symptoms/signs from free text clinical fields. Time points were defined for initial symptomatic presentation, chest imaging, specialist consultation, diagnostic confirmation, and treatment initiation. Median and interquartile ranges (IQR) were calculated for intervals spanning these time points. The mean age of the cohort was 67.3 years, 54.1% had Stage III or IV disease and the majority were diagnosed after clinical presentation (94.5%) rather than screening (5.5%). Median intervals from first recorded symptoms/signs to diagnosis was 570 days (IQR 273-691), from chest CT or chest X-ray imaging to diagnosis 43 days (IQR 11-240), specialist consultation to diagnosis 72 days (IQR 13-456), and from diagnosis to treatment initiation 7 days (IQR 0-36). Symptoms/signs associated with lung cancer can be identified over a year prior to diagnosis using NLP, highlighting the need for CQMs to improve timeliness of diagnosis.

Diagnostic Accuracy of an At-Home, Rapid Self-test for Influenza: Prospective Comparative Accuracy Study.

BACKGROUND: Rapid diagnostic tests (RDTs) for influenza used by individuals at home could potentially expand access to testing and reduce the impact of influenza on health systems. Improving access to testing could lead to earlier diagnosis following symptom onset, allowing more rapid interventions for those who test positive, including behavioral changes to minimize spread. However, the accuracy of RDTs for influenza has not been determined in self-testing populations. OBJECTIVE: This study aims to assess the accuracy of an influenza RDT conducted at home by lay users with acute respiratory illness compared with that of a self-collected sample by the same individual mailed to a laboratory for reference testing. METHODS: We conducted a comparative accuracy study of an at-home influenza RDT (Ellume) in a convenience sample of individuals experiencing acute respiratory illness symptoms. Participants were enrolled in February and March 2020 from the Greater Seattle region in Washington, United States. Participants were mailed the influenza RDT and reference sample collection materials, which they completed and returned for quantitative reverse-transcription polymerase chain reaction influenza testing in a central laboratory. We explored the impact of age, influenza type, duration, and severity of symptoms on RDT accuracy and on cycle threshold for influenza virus and ribonuclease P, a marker of human DNA. RESULTS: A total of 605 participants completed all study steps and were included in our analysis, of whom 87 (14.4%) tested positive for influenza by quantitative reverse-transcription polymerase chain reaction (70/87, 80% for influenza A and 17/87, 20% for influenza B). The overall sensitivity and specificity of the RDT compared with the reference test were 61% (95% CI 50%-71%) and 95% (95% CI 93%-97%), respectively. Among individuals with symptom onset ≤72 hours, sensitivity was 63% (95% CI 48%-76%) and specificity was 94% (95% CI 91%-97%), whereas, for those with duration >72 hours, sensitivity and specificity were 58% (95% CI 41%-74%) and 96% (95% CI 93%-98%), respectively. Viral load on reference swabs was negatively correlated with symptom onset, and quantities of the endogenous marker gene ribonuclease P did not differ among reference standard positive and negative groups, age groups, or influenza subtypes. The RDT did not have higher sensitivity or specificity among those who reported more severe illnesses. CONCLUSIONS: The sensitivity and specificity of the self-test were comparable with those of influenza RDTs used in clinical settings. False-negative self-test results were more common when the test was used after 72 hours of symptom onset but were not related to inadequate swab collection or severity of illness. Therefore, the deployment of home tests may provide a valuable tool to support the management of influenza and other respiratory infections.

Evaluating an app-guided self-test for influenza: lessons learned for improving the feasibility of study designs to evaluate self-tests for respiratory viruses.

BACKGROUND: Seasonal influenza leads to significant morbidity and mortality. Rapid self-tests could improve access to influenza testing in community settings. We aimed to evaluate the diagnostic accuracy of a mobile app-guided influenza rapid self-test for adults with influenza like illness (ILI), and identify optimal methods for conducting accuracy studies for home-based assays for influenza and other respiratory viruses. METHODS: This cross-sectional study recruited adults who self-reported ILI online. Participants downloaded a mobile app, which guided them through two low nasal swab self-samples. Participants tested the index swab using a lateral flow assay. Test accuracy results were compared to the reference swab tested in a research laboratory for influenza A/B using a molecular assay. RESULTS: Analysis included 739 participants, 80% were 25-64 years of age, 79% female, and 73% white. Influenza positivity was 5.9% based on the laboratory reference test. Of those who started their test, 92% reported a self-test result. The sensitivity and specificity of participants' interpretation of the test result compared to the laboratory reference standard were 14% (95%CI 5-28%) and 90% (95%CI 87-92%), respectively. CONCLUSIONS: A mobile app facilitated study procedures to determine the accuracy of a home based test for influenza, however, test sensitivity was low. Recruiting individuals outside clinical settings who self-report ILI symptoms may lead to lower rates of influenza and/or less severe disease. Earlier identification of study subjects within 48 h of symptom onset through inclusion criteria and rapid shipping of tests or pre-positioning tests is needed to allow self-testing earlier in the course of illness, when viral load is higher.

Experiences along the diagnostic pathway for patients with advanced lung cancer in the USA: a qualitative study.

BACKGROUND: Most patients with lung cancer are diagnosed at advanced stages. However, the advent of oral targeted therapies has improved the prognosis of many patients with lung cancer. PURPOSE: We aimed to understand the diagnostic experiences of patients with advanced lung cancer with oncogenic mutations. METHODS: Qualitative interviews were conducted with patients with advanced or metastatic non-small cell lung cancer with oncogenic alterations. Patients were recruited from online support groups within the USA. Interviews were conducted remotely or in person. Analysis used an iterative inductive and deductive process. Themes were mapped to the Model for Pathways to Treatment. RESULTS: 40 patients (12 male and 28 female) with a median age of 48 were included. We identified nine distinct themes. During the 'patient interval', individuals became concerned about symptoms, but often attributed them to other causes. Prolonged or more severe symptoms prompted care-seeking. During the 'primary care interval', doctors initially treated for illnesses other than cancer. Discovery of an imaging abnormality was a turning point in diagnostic pathways. Occasionally, severity of symptoms prompted patients to seek emergency care. During the 'secondary care interval', obtaining tissue samples was pivotal in confirming diagnosis. Delays in accessing oncology care sometimes led to patient distress. Obtaining genetic testing was crucial in directing patients to receive targeted treatments. CONCLUSIONS: Patients experienced multiple different routes to their diagnosis. Some patients perceived delays, inefficiencies and lack of coordination, which could be distressing. Shifting the stage of diagnosis of lung cancer to optimise the impact of targeted therapies will require concerted efforts in early detection.

The Seattle Flu Study: a multiarm community-based prospective study protocol for assessing influenza prevalence, transmission and genomic epidemiology.

INTRODUCTION: Influenza epidemics and pandemics cause significant morbidity and mortality. An effective response to a potential pandemic requires the infrastructure to rapidly detect, characterise, and potentially contain new and emerging influenza strains at both an individual and population level. The objective of this study is to use data gathered simultaneously from community and hospital sites to develop a model of how influenza enters and spreads in a population. METHODS AND ANALYSIS: Starting in the 2018-2019 season, we have been enrolling individuals with acute respiratory illness from community sites throughout the Seattle metropolitan area, including clinics, childcare facilities, Seattle-Tacoma International Airport, workplaces, college campuses and homeless shelters. At these sites, we collect clinical data and mid-nasal swabs from individuals with at least two acute respiratory symptoms. Additionally, we collect residual nasal swabs and data from individuals who seek care for respiratory symptoms at four regional hospitals. Samples are tested using a multiplex molecular assay, and influenza whole genome sequencing is performed for samples with influenza detected. Geospatial mapping and computational modelling platforms are in development to characterise the regional spread of influenza and other respiratory pathogens. ETHICS AND DISSEMINATION: The study was approved by the University of Washington's Institutional Review Board (STUDY00006181). Results will be disseminated through talks at conferences, peer-reviewed publications and on the study website (www.seattleflu.org).

Qualitative study to explore radiologist and radiologic technologist perceptions of outcomes patients experience during imaging in the USA.

OBJECTIVE: We aimed to explore the patient-centred outcomes (PCOs) radiologists and radiologic technologists perceive to be important to patients undergoing imaging procedures. DESIGN: We conducted a qualitative study of individual semi-structured interviews. PARTICIPANTS: We recruited multiple types of radiologists including general, musculoskeletal neuroradiology, body and breast imagers as well as X-ray, ultrasound, CT or MRI radiologic technologists from Washington and Idaho. OUTCOME: Thematic analysis was conducted to identify themes and subthemes related to PCOs of imaging procedures. RESULTS: Ten radiologists and six radiology technologists participated. Four main domains of PCOs were identified: emotions, physical factors, knowledge and patient burden. In addition to these outcomes, we also identified patient and provider factors that can potentially moderate these outcomes. CONCLUSIONS: Radiologists and technologists perceived outcomes related to the effect of imaging procedures on patients' emotions, physical well-being, knowledge and burden from financial and opportunity costs to be important to patients undergoing imaging procedures. There are opportunities for the radiology community to measure and use these PCOs in comparisons of imaging procedures and potentially identify areas where these outcomes can be leveraged to drive a more patient-centred approach to radiology.

Sudden Death Associated With Sickle Cell Trait Before and After Mandatory Screening.

BACKGROUND: Sickle cell trait (SCT) has been associated with an increased risk of sudden death in athletes during strenuous exercise. In August 2010, the National Collegiate Athletic Association (NCAA) began requiring athletes to be screened for SCT, provide proof of SCT status, or sign a waiver and launched an educational campaign for athletes, coaches, and medical staff. The impact of this program is unknown. The purpose of this study was to determine the incidence of death associated with sickle cell trait (daSCT) in NCAA athletes before and after legislation. HYPOTHESIS: NCAA SCT legislation will decrease the incidence of daSCT. STUDY DESIGN: Observational study. LEVEL OF EVIDENCE: Level 2. METHODS: A database of NCAA athlete deaths from 2000 to 2019 was reviewed for daSCT. A total of 8,309,050 athlete-years (AY) were included. Incidence of death was calculated before and after legislation. RESULTS: The incidence of daSCT in Division I (DI) football athletes before legislation (n = 9) was 1:28,145 AY and after legislation (n = 1) was 1:250,468 AY (relative risk [RR], 0.112; 95% CI, 0.003-0.811; P = 0.022), an 89% reduction in risk after legislation was enacted. The incidence of daSCT in African American DI football athletes before legislation (n = 9) was 1:12,519 AY and after legislation (n = 1) was 1:118,464 AY (RR, 0.106; 95% CI, 0.002-0.763; P = 0.017), also an 89% risk reduction after legislation was enacted. For all NCAA athletes, the incidence of daSCT was 1:489,749 AY before legislation (n = 10) and 1:1,705,780 AY after legislation (n = 2) (RR, 0.288; 95% CI, 0.031-1.347; P = 0.146). CONCLUSION: The incidence of daSCT in DI football athletes has decreased significantly since legislation was enacted. Cases of daSCT outside of football are rare. It is unclear whether the decrease is related to screening for SCT, education, or both. CLINICAL RELEVANCE: This is the first evidence that NCAA SCT legislation may save lives.

Diagnostic accuracy of an app-guided, self-administered test for influenza among individuals presenting to general practice with influenza-like illness: study protocol.

INTRODUCTION: Diagnostic tests for influenza in Australia are currently only authorised for use in clinical settings. At-home diagnostic testing for influenza could reduce the need for patient contact with healthcare services, which potentially could contribute to symptomatic improvement and reduced spread of influenza. We aim to determine the accuracy of an app-guided nasal self-swab combined with a lateral flow immunoassay for influenza conducted by individuals with influenza-like illness (ILI). METHODS AND ANALYSIS: Adults (≥18 years) presenting with ILI will be recruited by general practitioners (GP) participating in Australian Sentinel Practices Research Network. Eligible participants will have a nasal swab obtained by their GP for verification of influenza A/B status using reverse transcription polymerase chain reaction (RT-PCR) test at an accredited laboratory. Participants will receive an influenza test kit and will download an app that collects self-reported symptoms and influenza risk factors, then instructs them in obtaining a low-nasal self-swab, running a QuickVue influenza A+B lateral flow immunoassay (Quidel Corporation) and interpreting the results. Participants will also interpret an enhanced image of the test strip in the app. The primary outcome will be the accuracy of participants' test interpretation compared with the laboratory RT-PCR reference standard. Secondary analyses will include accuracy of the enhanced test strip image, accuracy of an automatic test strip reader algorithm and validation of prediction rules for influenza based on self-reported symptoms. A post-test survey will be used to obtain participant feedback on self-test procedures. ETHICS AND DISSEMINATION: The study was approved by the Human Research and Ethic Committee (HREC) at the University of Adelaide (H-2019-116). Protocol details and any amendments will be reported to https://www.tga.gov.au/. Results will be published in the peer-reviewed literature, and shared with stakeholders in the primary care and diagnostics communities. TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trial Registry (U1111-1237-0688).

A Secondary Analysis to Identify Patient-Centered Outcomes in the ACR's Appropriateness Criteria.

CONTEXT: There is a growing body of literature indicating imaging testing can affect patients cognitively, socially, behaviorally, and emotionally. The extent to which these patient-centered outcomes (PCOs) are reported in the imaging literature is unclear. Identifying PCOs may facilitate shared decision making around imaging testing. OBJECTIVE: To identify PCOs across a spectrum of clinical topics included in the ACR's Appropriateness Criteria (AC). METHODS: We systematically reviewed AC evidence tables for eligible articles of studies conducted in any clinical setting in high-income countries. Included studies reported PCOs occurring as a direct or indirect result of an imaging test performed for any reason (eg, diagnosis, screening, surveillance, or staging). PCOs and the methods used to measure them were extracted through a secondary analysis and descriptive synthesis. RESULTS: Our search identified 89 articles that reported outcomes of radiation exposure (n = 37), downstream testing (n = 20), complications (n = 19), incidental findings (n = 10), quality of life (n = 7), physical discomfort (n = 5), patient values and experiences (n = 4), patient financial and time costs (n = 4), psychosocial outcomes (n = 4), and test duration (n = 2). These outcomes were rarely reported from the patient perspective and were measured using a range of standardized or validated and nonstandardized methods. CONCLUSIONS: We identified few PCOs incorporated in the AC. Our findings reflect the historical emphasis of diagnostic research on accuracy, clinical utility, and selected outcomes (eg, adverse events). As radiology moves to a more patient-centered approach, it will be important to measure PCOs reported directly from patients.

Provider Perspectives of Patient Experiences in Primary Care Imaging.

BACKGROUND: Imaging tests are a widely used tool in primary care with many known benefits. Without an understanding of which outcomes matter the most to patients, clinicians are challenged to balance the benefits and harms of imaging tests. This study aimed to explore the perceived impacts imaging tests have on patients from the perspective of the primary care providers (PCPs) and determine PCPs' understanding of patient-centered outcomes (PCOs) from imaging tests. METHODS: Recruitment of PCPs occurred at 4 family medicine clinics in Washington and Idaho. Primary care physicians, nurse practitioners, or physician assistants who order imaging tests were eligible to participate. Semistructured interviews explored providers' perceptions of patient experiences during the process of ordering, performing and following up on imaging tests. Classic content analysis generated themes and subthemes. RESULTS: Sixteen PCPs, including 11 physicians, 3 physician assistants, and 2 nurse practitioners, completed interviews. Two themes were identified: 1) perceived PCOs, and 2) factors influencing the incorporation of PCOs into clinical management. Perceived outcomes included emotions related to the answer a test provides and costs to the patient such as monetary, physical, and added risk. Patient expectations, provider-patient communication, and inadequate knowledge all contributed as barriers to incorporating PCOs into clinical management. DISCUSSION: PCPs recognize different outcomes of imaging tests that they consider important for patients. While providers are perceptive to patient outcomes there remains a challenge to how patient outcomes are used to improve care. Communication with patients and improving provider knowledge are needed to incorporate identified PCOs.

Patient-Centered Outcomes Related to Imaging Testing in US Primary Care.

BACKGROUND: Imaging tests are one of the most sophisticated types of diagnostic tools used in health care, yet there are concerns that imaging is overused. Currently, tests are typically evaluated and implemented based on their accuracy, and there is limited knowledge about the range of patient-centered outcomes (PCOs) that imaging tests may lead to. This study explores patients' experiences and subsequent outcomes of imaging tests most notable to patients. METHODS: Adult patients from four primary care clinics who had an x-ray, CT, MRI, or ultrasound in the 12 months before recruitment participated in a single semistructured interview to recount their imaging experience. Interview transcripts were analyzed thematically. RESULTS: Four themes related to PCOs were identified from 45 interviews. Participants' mean age was 53 years (25-83 years), 30 had undergone a diagnostic imaging test, and 15 underwent imaging for screening or monitoring. Themes included knowledge gained from the imaging test, its contribution to their overall health care journey, physical experiences during the test procedure, and impacts of the testing process on emotions. CONCLUSIONS: Patients identified various imaging test outcomes that were important to them. Measurement and reporting these outcomes should be considered more often in diagnostic research. Tools for providers and patients to discuss and utilize these outcomes may help promote shared decision making around the use and impact of imaging tests.