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.

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.

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.