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

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

Abstract 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

Patient-centred outcomes of imaging tests: recommendations for patients, clinicians and researchers.

BACKGROUND: Imaging tests are one of the most frequently used diagnostic modalities in healthcare, but the benefits of their direct impacts on clinical decision-making have been countered by concerns that they can be overused. Assessing the relative value of imaging tests has largely focused on measures of test accuracy, which overlooks more comprehensive benefits and risks of imaging tests, particularly their impact on patient-centred outcomes (PCOs). We present the findings of the Patient Reported Outcomes of Diagnostics (PROD) research study in response to a methodological gap in the area of diagnostic test comparative effectiveness research. METHODS: Over a 3-year period, the PROD Study engaged with multiple stakeholders to identify existing conceptual models related to PCOs for imaging testing, conducted primary research and evidence synthesis, and developed consensus recommendations to describe and categorise PCOs related to imaging testing. RESULTS: The PROD framework categorises PCOs from imaging studies within four main domains: information or knowledge yielded, physical impact, emotional outcomes and test burden. PCOs interact with each other and influence effects across domains, and can be modified by factors related to the patient, clinical situation, healthcare team and the testing environment. CONCLUSIONS: Using PCOs to inform healthcare decision-making will require ways of collating and presenting information on PCOs in ways that can inform patient-provider decision-making, and developing methods to determine the relative importance of outcomes (including test accuracy) to one another