Now showing items 1-20 of 2092

    • Feasibility of At-Home Serial Testing Using Over-the-Counter SARS-CoV-2 Tests With a Digital Smartphone App for Assistance: Longitudinal Cohort Study

      Herbert, Carly; Broach, John; Heetderks, William; Qashu, Felicia; Gibson, Laura; Pretz, Caitlin; Woods, Kelsey; Kheterpal, Vik; Suvarna, Thejas; Nowak, Christopher; et al. (2022-10-18)
      Background: The ongoing SARS-CoV-2 pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb disease transmission, morbidity, and mortality. Rapid antigen tests are important tools for scaling up testing for SARS-CoV-2; however, little is known about individuals' use of rapid antigen tests at home and how to facilitate the user experience. Objective: This study aimed to describe the feasibility and acceptability of serial self-testing with rapid antigen tests for SARS-CoV-2, including need for assistance and the reliability of self-interpretation. Methods: A total of 206 adults in the United States with smartphones were enrolled in this single-arm feasibility study in February and March 2021. All participants were asked to self-test for COVID-19 at home using rapid antigen tests daily for 14 days and use a smartphone app for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, the acceptability of testing and smartphone app experiences, and the reliability of participants versus study team's interpretation of test results. Descriptive statistics were used to report the acceptability, adherence, overall rating, and experience of using the at-home test and MyDataHelps app. The usability, acceptability, adherence, and quality of at-home testing were analyzed across different sociodemographic, age, and educational attainment groups. Results: Of the 206 enrolled participants, 189 (91.7%) and 159 (77.2%) completed testing and follow-up surveys, respectively. In total, 51.3% (97/189) of study participants were women, the average age was 40.7 years, 34.4% (65/189) were non-White, and 82% (155/189) had a bachelor's degree or higher. Most (n=133/206, 64.6%) participants showed high testing adherence, meaning they completed over 75% of the assigned tests. Participants' interpretations of test results demonstrated high agreement (2106/2130, 98.9%) with the study verified results, with a κ score of 0.29 (P<.001). Participants reported high satisfaction with self-testing and the smartphone app, with 98.7% (157/159) reporting that they would recommend the self-test and smartphone app to others. These results were consistent across age, race/ethnicity, and gender. Conclusions: Participants' high adherence to the recommended testing schedule, significant reliability between participants and study staff's test interpretation, and the acceptability of the smartphone app and self-test indicate that self-tests for SARS-CoV-2 with a smartphone app for assistance and reporting is a highly feasible testing modality among a diverse population of adults in the United States.
    • Differences in Hospital, Emergency Room and Outpatient Visits Among Adults With and Without Monoclonal Gammopathy of Undetermined Significance

      Castañeda-Avila, Maira A; Lapane, Kate L; Person, Sharina D; Jesdale, Bill M; Zhou, Yanhua; Mazor, Kathleen M; Epstein, Mara M (2022-09-14)
      Introduction: This study evaluated the impact of receiving a monoclonal gammopathy of undetermined significance (MGUS) diagnosis on healthcare utilization from patients at a community-based multispecialty provider organization. Methods: A cohort of patients with MGUS (n = 429) were matched on sex, age, and length of enrollment to a cohort of patients without MGUS (n = 1286). Healthcare utilization was assessed: 1-12 months before, 1 month before and after, and 1-12 months after diagnosis/index date. Multivariable conditional Poisson models compared change in utilization of each service in patients with and without MGUS. Results: During the 2 months around diagnosis/index date, the rates of emergency room, hospital and outpatient visits were higher for patients with MGUS than patients without MGUS. In the year before MGUS diagnosis, the association was still elevated, although attenuated. Conclusion: Understanding the care of MGUS patients is important given that multiple myeloma patients with a pre-existing MGUS diagnosis may have a better prognosis.
    • Clinician perspectives on pediatric COVID-19 vaccination: A qualitative study in central and western, Massachusetts

      Ryan, Grace W; Goulding, Melissa; Borg, Amy; Minkah, Princilla; Hermann, Sophie; Fisher, Lloyd; Rosal, Milagros C.; Lemon, Stephenie C. (2022-09-01)
      We explored perspectives of clinicians in central and western Massachusetts about efforts to vaccinate pediatric patients against COVID-19 as well as best practices and challenges for vaccine delivery. We conducted semi-structured qualitative interviews (n = 16) with family practice and pediatric clinicians between late October and early December 2021. Our interviews addressed: process for vaccination and vaccine promotion, parental receptivity to COVID-19 vaccination, receptivity to other pediatric vaccines, resources needed to support vaccine promotion, and best practices developed to encourage hesitant parents. Using a multi-prong recruitment strategy we invited clinicians to participate in telephone interviews, which were audio-recorded and transcribed. We used rapid qualitative analysis to produce summary templates for each interview which were ultimately combined into a matrix summary. The majority of participants (n = 10) were offering the vaccine in their own clinics, while the remainder cited challenges related to staffing, logistics, and space that prevented them from offering the vaccine. Clinicians reported parents fall into three groups: vaccine-accepting, hesitant but potentially accepting, and refusers. Strategies they identified that worked to encourage hesitant parents were sharing personal vaccine stories, acknowledging parents' fears about the vaccine, and being persistent with the most hesitant parents. Yet resources are needed including educational materials and training in how to have these conversations. While challenges related to staffing and space will be difficult to overcome for clinics to be able to offer vaccination on-site, our results highlight the importance of developing effective messaging strategies and training clinicians in how to integrate them into routine practice.
    • Effects of Intimate Partner Violence During COVID-19 and Pandemic-Related Stress on the Mental and Physical Health of Women Veterans

      Iverson, Katherine M; Dardis, Christina M; Cowlishaw, Sean; Webermann, Aliya R; Shayani, Danielle R; Dichter, Melissa E; Mitchell, Karen S; Mattocks, Kristin M.; Gerber, Megan R; Portnoy, Galina R (2022-08-30)
      Background: Little is known about women veterans' intimate partner violence (IPV) experiences during the COVID-19 pandemic or the impacts of pandemic-related stress on their mental and physical health. Objectives: To identify IPV experiences among women veterans prior to and during the pandemic, pandemic-related stressors, and examine their respective contributions to mental and physical health. Design: National sample of women veterans drawn from a larger web-based longitudinal study. Relationships between recent IPV and pandemic-related stressors were tested with linear regressions, controlling for pre-pandemic IPV and mental and physical health symptoms, demographic, and military-related covariates. Participants: One hundred forty-two women veterans (Mage=58.8 years). Main measures: We assessed IPV (CTS-2), PTSD (PCL-5), depression (CESD), anxiety (DASS-A), physical health (PHQ-15), and physical health-related quality of life (SF-12) prior to the pandemic (June 2016-December 2016/January 2017) and during the pandemic study period (March 2020-December 2020/January 2021). We assessed pandemic-related stressors (EPII) during the pandemic study period. Key results: Over a third (38.7%) of participants experienced IPV during the pandemic study period (psychological: 35.9%, physical: 9.9%, sexual: 4.2%). Overall rates, frequency, and severity of IPV experience did not significantly differ between the pre-pandemic and pandemic study periods. Few participants tested positive for COVID-19 (4.2%); however, most participants reported experiencing pandemic-related stressors across life domains (e.g., social activities: 88%, physical health: 80.3%, emotional health: 68.3%). IPV during the pandemic and pandemic-related stressors were both associated with greater PTSD and depressive symptoms. Pandemic-related stressors were associated with worse anxiety and physical health symptoms. Neither IPV during the pandemic nor pandemic-related stressors were associated with physical health-related quality of life. Conclusions: IPV experiences during the pandemic were common among women veterans, as were pandemic-related stressors. Although IPV did not increase in the context of COVID-19, IPV experiences during the pandemic and pandemic-related stressors were linked with poorer mental and physical health.
    • Examining Pregnant Veterans' Acceptance and Beliefs Regarding the COVID-19 Vaccine

      Mattocks, Kristin M.; Kroll-Desrosiers, Aimee R.; Moore Simas, Tiffany A.; Bastian, Lori A; Marteeny, Valerie; Walker, Lorrie; Sheahan, Kate; Elwy, A Rani (2022-08-30)
      Background: Pregnant persons have received mixed messages regarding whether or not to receive COVID-19 vaccines as limited data are available regarding vaccine safety for pregnant and lactating persons and breastfeeding infants. Objective: The aims of this study were to examine pregnant Veteran's acceptance of COVID-19 vaccines, along with perceptions and beliefs regarding vaccine safety and vaccine conspiracy beliefs. Design and participants: We conducted a cross-sectional survey of pregnant Veterans enrolled in VA care who were taking part in an ongoing cohort study at 15 VA medical centers between January and May 2021. Main measures: Pregnant Veterans were asked whether they had been offered the COVID-19 vaccine during pregnancy, and whether they chose to accept or refuse it. Additional questions focused on perceptions of COVID-19 vaccine safety and endorsements of vaccine knowledge and conspiracy beliefs. Logistic regression was utilized to examine predictors of acceptance of a vaccine during pregnancy. Key results: Overall, 72 pregnant Veterans were offered a COVID-19 vaccine during pregnancy; over two-thirds (69%) opted not to receive a vaccine. Reasons for not receiving a vaccine included potential effects on the baby (64%), side effects for oneself (30%), and immunity from a past COVID-19 infection (12%). Those who received a vaccine had significantly greater vaccine knowledge and less belief in vaccine conspiracy theories. Greater knowledge of vaccines in general (aOR: 1.78; 95% CI: 1.2-2.6) and lower beliefs in vaccine conspiracies (aOR: 0.76; 95% CI: 0.6-0.9) were the strongest predictors of acceptance of a COVID-19 vaccine during pregnancy. Conclusions: Our study provides important insights regarding pregnant Veterans' decisions to accept the COVID-19 vaccine, and reasons why they may choose not to accept the vaccine. Given the high endorsement of vaccine conspiracy beliefs, trusted healthcare providers should have ongoing, open discussions about vaccine conspiracy beliefs and provide additional information to dispel these beliefs.
    • Exploring the Acceptability of Expanded Perinatal Depression Care Practices Among Women Veterans

      Kroll-Desrosiers, Aimee; Kinney, Rebecca L; Marteeny, Valerie; Mattocks, Kristin M (2022-08-30)
      Background: Veterans receive obstetrical care from community-based providers contracted through the Veterans Health Administration (VA); however, Veterans remain eligible for VA mental healthcare in the perinatal period. To date, few studies have focused specifically on the mental health needs of Veterans during the perinatal period. Objective: To examine the acceptability of more comprehensive perinatal mental healthcare screening and treatment in VA care, we explored pregnant and postpartum Veteran perspectives of United States Preventive Services Task Force (USPSTF) recommendations that aim to expand mental health counseling for the prevention and treatment of perinatal depression. Design: Semi-structured interviews with pregnant and postpartum Veterans enrolled in VA care, integrated with quantitative survey data. Participants: Pregnant and postpartum Veterans (n=27) who had delivered infants or were due by February 2020. Approach: Framework analysis with an inductive approach was utilized to understand our data, interpret and code our transcripts, and develop themes. Key results: Fewer than half (44%) of the women reported seeing a mental health provider at the beginning of their pregnancy. We found that Veterans support USPSTF recommendations in the VA, consider mental healthcare to be very important during the perinatal period, would like better access to mental healthcare resources and peer support networks, and suggest that perinatal depression screening could be more extensive. Conclusions: These findings support the implementation of more comprehensive perinatal depression prevention policies and practices within VA care. Understanding the real-world feasibility and prevailing barriers to comprehensive perinatal depression care is needed to inform implementation of the USPSTF recommendations or a similar intervention tailored for VA care.
    • Advance Care Planning in Serious Illness: A Narrative Review

      Rosa, William E; Izumi, Shigeko; Sullivan, Donald R; Lakin, Joshua; Rosenberg, Abby R; Creutzfeldt, Claire J; Lafond, Debbie; Tjia, Jennifer; Cotter, Valerie; Wallace, Cara; et al. (2022-08-24)
      Context: Advance care planning (ACP) intends to support person-centered medical decision-making by eliciting patient preferences. Research has not identified significant associations between ACP and goal-concordant end-of-life care, leading to justified scientific debate regarding ACP utility. Objective: To delineate ACP's potential benefits and missed opportunities and identify an evidence-informed, clinically relevant path ahead for ACP in serious illness. Methods: We conducted a narrative review merging the best available ACP empirical data, grey literature, and emergent scholarly discourse using a snowball search of PubMed, Medline, and Google Scholar (2000-2022). Findings were informed by our team's interprofessional clinical and research expertise in serious illness care. Results: Early ACP practices were largely tied to mandated document completion, potentially failing to capture the holistic preferences of patients and surrogates. ACP models focused on serious illness communication rather than documentation show promising patient and clinician results. Ideally, ACP would lead to goal-concordant care even amid the unpredictability of serious illness trajectories. But ACP might also provide a false sense of security that patients' wishes will be honored and revisited at end-of-life. An iterative, 'building block' framework to integrate ACP throughout serious illness is provided alongside clinical practice, research, and policy recommendations. Conclusions: We advocate a balanced approach to ACP, recognizing empirical deficits while acknowledging potential benefits and ethical imperatives (e.g., fostering clinician-patient trust and shared decision-making). We support prioritizing patient/surrogate-centered outcomes with more robust measures to account for interpersonal clinician-patient variables that likely inform ACP efficacy and may better evaluate information gleaned during serious illness encounters.
    • Usefulness of Self-Reported Physical Activity and Clinical Outcomes in Older Patients With Atrial Fibrillation

      Dai, Qiying; Mehawej, Jordy; Saczynski, Jane S; Tran, Khanh-Van; Abu, Hawa O; Lessard, Darleen; Fillippaios, Andreas; Paul, Tenes; Hariri, Essa; Wang, Weijia; et al. (2022-08-18)
      Current guidelines encourage regular physical activity (PA) to gain cardiovascular health benefit. However, little is known about whether older adults with atrial fibrillation (AF) who engage in the guideline-recommended level of PA are less likely to experience clinically relevant outcomes. We did a retrospective study based on the data from Systemic Assessment of Geriatric Elements in AF (SAGE-AF) prospective cohort study. The study population consisted of older participants with AF (≥65 years) and a congestive heart failure, hypertension, age, diabetes, stroke vascular disease, age 65 to 75 and sex(CHA2DS2-VASc) score ≥2. PA was quantified by self-reported Minnesota Leisure Time PA questionnaire. Competing risk models were used to examine the association between PA level and clinical outcomes over 2 years while controlling for several potentially confounding variables. A total of 1,244 participants (average age 76 years; 51% men; 85% non-Hispanic White) were studied. A total of 50.5% of participants engaged in regular PA. Meeting the recommended level of PA was associated with lower mortality over 2 years (adjusted hazard ratio 0.60, 95% confidence interval 0.38 to 0.95) but was not associated with rates of stroke or major bleeding. In conclusion, older adults with AF who engaged in guideline-recommended PA are more likely to survive in the long term. Healthcare providers should promote and encourage engagement in PA and tailor interventions to address barriers of engagement.
    • Examining pathways between family or peer factors and smoking cessation in a nationally representative US sample of adults with mental health conditions who smoke: a structural equation analysis

      Nagawa, Catherine S; Wang, Bo; Davis, Maryann; Pbert, Lori; Cutrona, Sarah L; Lemon, Stephenie C; Sadasivam, Rajani S (2022-08-17)
      Background: Supportive family or peer behaviors positively impact smoking cessation in people with mental health problems who smoke. However, the limited understanding of the pathways through which family or peer factors impact quitting limits the development of effective support interventions. This study examined pathways through which family or peer views on tobacco use, family or peer smoking status, and rules against smoking in the home influenced quitting in adults with mental health problems who smoke. Methods: We used data from the Population Assessment of Tobacco and Health Study, a national longitudinal survey. Baseline data were collected in 2015, and follow-up data in 2016. We included adults' current smokers who had experienced two or more mental health symptoms in the past year (unweighted n = 4201). Structural equation modeling was used to test the relationships between family and peer factors, mediating factors, and smoking cessation. Results: We found that having family or peers with negative views on tobacco use had a positive indirect effect on smoking cessation, mediated through the individual's intention to quit (regression coefficient: 0.19) and the use of evidence-based approaches during their past year quit attempt (regression coefficient: 0.32). Having rules against smoking in the home (regression coefficient: 0.33) and having non-smoking family members or peers (regression coefficient: 0.11) had a positive indirect effect on smoking cessation, mediated through smoking behaviors (regression coefficient: 0.36). All paths were statistically significant (p < 0.01). The model explained 20% of the variability in smoking outcomes. Conclusion: Family or peer-based cessation interventions that systematically increase intentions to quit and monitor smoking behavior may be able to assess the efficacy of family and peer support on quitting in people with mental health problems who smoke.
    • Rapid brain MRI protocols result in comparable differential diagnoses versus a full brain protocol in most canine and feline cases

      Johnson, Kelsey A; Sutherland-Smith, James; Oura, Trisha J; Sato, Amy F; Barton, Bruce (2022-08-15)
      Evaluation of brain disease in veterinary patients uses a wide variety of MRI sequences. A shortened protocol that maintains consistency of interpretation would reduce radiologist reporting time, patient anesthetic time, and client cost. The aims of this retrospective, methods comparison, observer agreement study were to evaluate whether abbreviated MRI protocols alter differential diagnoses and recommendations compared to our institution's standard protocol; evaluate interobserver agreement on standard brain MRIs; and assess whether differential diagnoses change after postcontrast images. Normal and pathologic canine and feline brain MRIs were retrieved from hospital archives. Three protocols were created from each: a 5-sequence noncontrast enhanced Fast Brain Protocol 1 (FBP1); a 6-sequence contrast-enhanced Fast Brain Protocol 2 (FBP2); and an 11-sequence standard brain protocol (SBP). Three blinded veterinary radiologists interpreted FBP images for 98 cases (1 reader/case) and SBP images for 20 cases (3 readers/case). A fourth observer compared these interpretations to the original MRI reports (OMR). Overall agreement between FBPs and OMR was good (k = 0.75) and comparable to interobserver agreement for multiple reviews of SBP cases. Postcontrast images substantially altered conclusions in 17/97 cases (17.5%), as well as improved interobserver agreement compared to noncontrast studies. The conclusions reached with shortened brain protocols were comparable to those of a full brain study. The findings supported the use of a 6-sequence brain MRI protocol (sagittal T2-weighted [T2w] TSE; transverse T2w turbo spin echo fluid-attenuated inversion recovery, T2*-weighted gradient recalled echo, T1-weighted spin echo, and diffusion weighted imaging/apparent diffusion coefficient; and postcontrast transverse T1-weighted spin echo) for dogs and cats with suspected intracranial disease.
    • Design and Formative Evaluation of a Virtual Voice-Based Coach for Problem-solving Treatment: Observational Study

      Kannampallil, Thomas; Ronneberg, Corina R; Wittels, Nancy E; Kumar, Vikas; Lv, Nan; Smyth, Joshua M; Gerber, Ben S; Kringle, Emily A; Johnson, Jillian A; Yu, Philip; et al. (2022-08-12)
      Background: Artificial intelligence has provided new opportunities for human interactions with technology for the practice of medicine. Among the recent artificial intelligence innovations, personal voice assistants have been broadly adopted. This highlights their potential for health care-related applications such as behavioral counseling to promote healthy lifestyle habits and emotional well-being. However, the use of voice-based applications for behavioral therapy has not been previously evaluated. Objective: This study aimed to conduct a formative user evaluation of Lumen, a virtual voice-based coach developed as an Alexa skill that delivers evidence-based, problem-solving treatment for patients with mild to moderate depression and/or anxiety. Methods: A total of 26 participants completed 2 therapy sessions-an introductory (session 1) and a problem-solving (session 2)-with Lumen. Following each session with Lumen, participants completed user experience, task-related workload, and work alliance surveys. They also participated in semistructured interviews addressing the benefits, challenges and barriers to Lumen use, and design recommendations. We evaluated the differences in user experience, task load, and work alliance between sessions using 2-tailed paired t tests. Interview transcripts were coded using an inductive thematic analysis to characterize the participants' perspectives regarding Lumen use. Results: Participants found Lumen to provide high pragmatic usability and favorable user experience, with marginal task load during interactions for both Lumen sessions. However, participants experienced a higher temporal workload during the problem-solving session, suggesting a feeling of being rushed during their communicative interactions. On the basis of the qualitative analysis, the following themes were identified: Lumen's on-demand accessibility and the delivery of a complex problem-solving treatment task with a simplistic structure for achieving therapy goals; themes related to Lumen improvements included streamlining and improved personalization of conversations, slower pacing of conversations, and providing additional context during therapy sessions. Conclusions: On the basis of an in-depth formative evaluation, we found that Lumen supported the ability to conduct cognitively plausible interactions for the delivery of behavioral therapy. Several design suggestions identified from the study including reducing temporal and cognitive load during conversational interactions, developing more natural conversations, and expanding privacy and security features were incorporated in the revised version of Lumen. Although further research is needed, the promising findings from this study highlight the potential for using Lumen to deliver personalized and accessible mental health care, filling a gap in traditional mental health services.
    • Association Between Patient Portal Use and Perceived Patient-Centered Communication Among Adults With Cancer: Cross-sectional Survey Study

      Zaidi, Maryum; Amante, Daniel J; Anderson, Ekaterina; Ito Fukunaga, Mayuko; Faro, Jamie M; Frisard, Christine; Sadasivam, Rajani S; Lemon, Stephenie C. (2022-08-09)
      Background: Patient-centered communication (PCC) plays a vital role in effective cancer management and care. Patient portals are increasingly available to patients and hold potential as a valuable tool to facilitate PCC. However, whether more frequent use of patient portals is associated with increased perceived PCC and which mechanisms might mediate this relationship have not been fully studied. Objective: The goal of this study was to investigate the association between the frequency of access of patient portals and perceived PCC in patients diagnosed with cancer. We further sought to examine whether this association was mediated by patients' self-efficacy in health information-seeking. Methods: We used data from the Health Information National Trend Survey 5 (HINTS 5) cycle 3 (2019) and cycle 4 (2020). This analysis includes 1222 individuals who self-reported having a current or past diagnosis of cancer. Perceived PCC was measured with a 7-item HINTS 5-derived scale and classified as low, medium, or high. Patient portal use was measured by a single item assessing the frequency of use. Self-efficacy about health information-seeking was assessed with a 1-item measure assessing confidence in obtaining health information. We used adjusted multinomial logistic regression models to estimate relative risk ratios (RRRs)/effect sizes of the association between patient portal use and perceived PCC. Mediation by health information self-efficacy was investigated using the Baron and Kenny and Karlson-Holm-Breen methods. Results: A total of 54.5% of the sample reported that they had not accessed their patient portals in the past 12 months, 12.6% accessed it 1 to 2 times, 24.8% accessed it 3 to 9 times, and 8.2% accessed it 10 or more times. Overall, the frequency of accessing the patient portal was marginally associated (P=.06) with perceived PCC in an adjusted multinominal logistic regression model. Patients who accessed their patient portal 10 or more times in the previous 12 months were almost 4 times more likely (RRR 3.8, 95% CI 1.6-9.0) to report high perceived PCC. In mediation analysis, the association between patient portal use and perceived PCC was attenuated adjusting for health information-seeking self-efficacy, but those with the most frequent patient portal use (10 or more times in the previous 12 months) were still almost 2.5 times more likely to report high perceived PCC (RRR 2.4, 95% CI 1.1-5.6) compared to those with no portal use. Conclusions: Increased frequency of patient portal use was associated with higher PCC, and an individual's health information-seeking self-efficacy partially mediated this association. These findings emphasize the importance of encouraging patients and providers to use patient portals to assist in patient-centeredness of cancer care. Interventions to promote the adoption and use of patient portals could incorporate strategies to improve health information self-efficacy.
    • Performance of Screening for SARS-CoV-2 using Rapid Antigen Tests to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection: findings from the Test Us at Home prospective cohort study [preprint]

      Soni, Apurv; Herbert, Carly; Lin, Honghuang; Pretz, Caitlin; Stamegna, Pamela; Orwig, Taylor; Wright, Colton; Tarrant, Seanan; Behar, Stephanie; Suvarna, Thejas; et al. (2022-08-06)
      Background: Performance of Rapid Antigen Tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance is not well established among asymptomatic individuals. Objective: Evaluate performance of Ag-RDT for detection of SARS-CoV-2 in relation to onset of infection for symptomatic and asymptomatic participants. Design setting and participants: Prospective cohort study conducted from October 2021 to February 2022 among participants > 2 years-old from across the US who enrolled using a smartphone app. During each testing encounter, participants self-collected one nasal swab and performed Ag-RDT at home; at-least fifteen minutes later, a second nasal swab was self-collected and shipped for SARS-CoV-2 RT-PCR at a central lab. Both nasal swabs were collected 7 times at 48-hour intervals (over approximately 14 days) followed by an extra nasal swab collection with home Ag-RDT test 48-hours after their last PCR sample. Each participant was assigned to one of the three emergency use authorized (EUA) Ag-RDT tests used in this study. This analysis was limited to participants who were asymptomatic and tested negative by antigen and molecular test on their first day of study participation. Exposure: SARS-CoV-2 positivity was determined by testing a single home-collected anterior nasal sample with three FDA EUA molecular tests, where 2 out 3 positive test results were needed to determine a SARS-CoV-2 positive result. Onset of infection was defined as day on which the molecular PCR comparator result was positive for the first time. Main outcomes and measures: Sensitivity of Ag-RDT was measured based on testing once (same-day), twice (at 48-hours) and thrice (at 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status on a given DPIPP. Results: A total of 7,361 participants enrolled in the study and 5,609 were eligible for this analysis. Among 154 eligible participants who tested positive for SARS-CoV-2 infection based on RT-PCR, 97 were asymptomatic and 57 had symptoms at onset of infection (DPIPP 0). Serial testing with Ag-RDT twice over 48-hours resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Among the 97 people who were asymptomatic at the onset of infection, 19 were singleton RT-PCR positive, i.e., their positive test was preceded and followed by a negative RT-PCR test within 48-hours. Excluding these singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with serial testing three times at 48-hour interval. Discussion: Performance of Ag-RDT within first week of infection was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.
    • Finding a Needle in the Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection [preprint]

      Soni, Apurv; Herbert, Carly; Pretz, Caitlin; Stamegna, Pamela; Filippaios, Andreas; Shi, Qiming; Suvarna, Thejas; Harman, Emma; Schrader, Summer; Nowak, Chris; et al. (2022-08-05)
      Background: Over-the-counter rapid antigen tests for SARS-CoV-2 with an Emergency Use Authorization (EUA) in the United States generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. A goal of this study was to investigate the performance of SARS-CoV-2 antigen serial testing and generate data to support regulatory decisions. Objective: To describe a novel study design to evaluate serial use of rapid antigen tests in detecting SARS-CoV-2 virus among asymptomatic individuals. Design: Prospective cohort study using a decentralized approach. Eligible participants from across the U.S. could enroll and complete this study from their home environment through a study app. Participant enrollment was prioritized based on regional 7-day case rates, participants' vaccination status, and sociodemographic characteristics prior to enrollment.Prioritization criteria were adjusted on a daily or weekly basis. Enrolled participants were mailed rapid antigen tests and molecular comparator collection kits and asked to test every 48 hours for 15 days. Three companies' rapid antigen tests were used in the study; assignment of participant to a test was criteria-based and non-random, precluding head-to-head comparison between the tests. Participants: Mainland United States residents over 2 years old with no reported COVID-19 symptoms in the 14 days prior to study enrollment. Main measures: Participant demographics, COVID-19 vaccination status, and geographic distribution were used to understand the impact of the site-less recruitment and enrollment strategy. Key results: A total of 7,361 participants enrolled in the study between October 18, 2021 and February 15, 2022. Throughout the study, 369 participants tested positive for SARS-CoV-2, including 167 who were asymptomatic and tested negative on SARS-CoV-2 molecular assays to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 of the 48 mainland U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The novel, digital site-less approach employed in the 'Test Us At Home' study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19, and can be adapted across research disciplines to optimize study enrollment and accessibility.
    • Use of a Digital Assistant to Report COVID-19 Rapid Antigen Self-test Results to Health Departments in 6 US Communities

      Herbert, Carly; Shi, Qiming; Kheterpal, Vik; Nowak, Chris; Suvarna, Thejas; Durnan, Basyl; Schrader, Summer; Behar, Stephanie; Naeem, Syed; Tarrant, Seanan; et al. (2022-08-01)
      Importance: Widespread distribution of rapid antigen tests is integral to the US strategy to address COVID-19; however, it is estimated that few rapid antigen test results are reported to local departments of health. Objective: To characterize how often individuals in 6 communities throughout the United States used a digital assistant to log rapid antigen test results and report them to their local departments of health. Design, setting, and participants: This prospective cohort study is based on anonymously collected data from the beneficiaries of the Say Yes! Covid Test program, which distributed more than 3 000 000 rapid antigen tests at no cost to residents of 6 communities (Louisville, Kentucky; Indianapolis, Indiana; Fulton County, Georgia; O'ahu, Hawaii; Ann Arbor and Ypsilanti, Michigan; and Chattanooga, Tennessee) between April and October 2021. A descriptive evaluation of beneficiary use of a digital assistant for logging and reporting their rapid antigen test results was performed. Interventions: Widespread community distribution of rapid antigen tests. Main outcomes and measures: Number and proportion of tests logged and reported to the local department of health through the digital assistant. Results: A total of 313 000 test kits were distributed, including 178 785 test kits that were ordered using the digital assistant. Among all distributed kits, 14 398 households (4.6%) used the digital assistant, but beneficiaries reported three-quarters of their rapid antigen test results to their state public health departments (30 965 tests reported of 41 465 total test results [75.0%]). The reporting behavior varied by community and was significantly higher among communities that were incentivized for reporting test results vs those that were not incentivized or partially incentivized (90.5% [95% CI, 89.9%-91.2%] vs 70.5%; [95% CI, 70.0%-71.0%]). In all communities, positive tests were less frequently reported than negative tests (60.4% [95% CI, 58.1%-62.8%] vs 75.5% [95% CI, 75.1%-76.0%]). Conclusions and relevance: These results suggest that application-based reporting with incentives may be associated with increased reporting of rapid tests for COVID-19. However, increasing the adoption of the digital assistant may be a critical first step.
    • Healthcare use in commercially insured youth with mental health disorders

      Hugunin, Julie; Davis, Maryann; Larkin, Celine; Baek, Jonggyu; Skehan, Brian; Lapane, Kate L (2022-07-26)
      Background: The objective of this study is to describe age-related patterns of outpatient healthcare utilization in youth and young adults with mental health disorders. Method: We used the IBM® MarketScan® Commercial Database to identify 359,413 youth and young adults (12-27 years) with a mental health disorder continuously enrolled in private health insurance in 2018. Exploratory analysis was used to describe patterns of outpatient healthcare use (e.g., primary, reproductive, mental health care) and therapeutic management (e.g., medication prescriptions, psychotherapy) by age. Period prevalence and median number of visits are reported. Additional analysis explored utilization patterns by mental health disorder. Results: The prevalence of outpatient mental health care and primary care decreased with age, with a larger drop in primary care utilization. While 74.0-78.4% of those aged 12-17 years used both outpatient mental health care and primary care, 53.1-59.7% of those aged 18-27 years did. Most 18-19-year-olds had a visit with an internal medicine or family medicine specialist, a minority had a pediatrician visit. The prevalence of medication management increased with age, while the prevalence of psychotherapy decreased. Conclusions: Taken together, this descriptive study illustrates age-related differences in outpatient healthcare utilization among those with mental health disorders. Additionally, those with the most severe mental health disorders seem to be least connected to outpatient care. This knowledge can inform efforts to improve utilization of healthcare across the transition to adulthood.
    • Integrated collaborative care intervention for depression and obesity in primary care: translation from research to practice

      Ronneberg, Corina R; Lv, Nan; Ajilore, Olusola A; Gerber, Ben S.; Venditti, Elizabeth M; Snowden, Mark B; Steinman, Lesley E; Wittels, Nancy E; Barve, Amruta; Dosala, Sushanth; et al. (2022-07-25)
      The objective of this study was to present lessons learned about engagement, delivery modality and pandemic impact while delivering a collaborative care intervention with a socioeconomically, racially and ethnically diverse sample. Participants completed a post-intervention survey (n = 41) on experiences and preferred intervention delivery modality, coronavirus 2019 (COVID-19) Impact Survey (n = 50) and provided open-ended feedback about the intervention (n = 27). Intervention process data included attendance, modality, and withdrawals. Data were analyzed using descriptive statistics and inductive content analyses. Of 71 intervention participants, 6 (8%) withdrew before session 1. Completers adhered to intervention timeline better than withdrawals. Participants liked the in-person interaction, efficient coach support, accountability of in-person and Zoom vs. phone sessions and the flexibility and convenience of phone and Zoom vs. in-person sessions. A majority of participants reported experiencing pandemic impacts such as heightened emotional distress, decreased activity engagement, poorer eating behaviors and being unable to meet basic needs. Participants deviating from intervention timelines may be re-engaged by targeted outreach attempts. Videoconference has the potential for providing as-needed coaching. Future interventions may be optimized to account for and address areas impacted by the pandemic. Findings revealed specific strategies that can be implemented in future interventions to improve emotional and physical health among diverse populations.
    • Development and test-retest reliability of a screening tool for axial spondyloarthritis

      Shridharmurthy, Divya; Lapane, Kate L.; Khan, Sara; Yi, Esther; Baek, Jonggyu; Kay, Jonathan; Liu, Shao-Hsien (2022-07-08)
      Background: People with axial Spondyloarthritis (axSpA) suffer from lengthy diagnostic delays of ~7 years. The usage of screening tools to identify axSpA patients in primary care can reduce diagnostic delays by facilitating early referral to rheumatologic care. The purpose of this study was to examine the psychometric properties of a potential screening tool for patients with axSpA. Method: Content validity was evaluated by soliciting feedback from 7 rheumatologists regarding the relevance and content representativeness of the proposed screening questions. For the test-retest study, participants ≥18 years of age with chronic back pain (≥3 months) without a diagnosis of mechanical or inflammatory back pain (n = 91) were e-recruited through ResearchMatch. Participation included completing identical baseline and follow-up questionnaires ~14 days apart. Weighted quadratic kappa was used to measure test-retest reliability between the two ratings of the ordinal scales. Construct validity was examined using exploratory factor analysis (EFA) and items with factor loadings ≥0.6 were extracted. Scale dimensionality and simplified factorial solutions were measured using Kaiser's criteria (Eigenvalue >1). Cronbach's alpha was used to measure internal consistency. Results: Most participants were women, non-Hispanic white, and had at least some college education, with a mean age of 45 years. On average, the age at onset of back pain was 31 years. Eleven questions yielded test-retest reliabilities ranging from 0.6 to 0.76. Results from EFA extracted two factors relating to: 1) how pain affects daily life functioning and 2) whether pain improves with movement. Internal consistency was high for questions evaluating how pain affects life, with a Cronbach's alpha of 0.81. Following assessment for validity and reliability, the questionnaire was revised to create the 6-item screening tool. Conclusions: The 6-item SpA-SED screening tool designed to identify potential cases of axSpA was found to have good test-retest reliability and high internal consistency.
    • Perception of atrial fibrillation symptoms: Impact on quality of life and treatment in older adults

      Abu, Hawa O; Wang, Weijia; Otabil, Edith M; Saczynski, Jane S; Mehawej, Jordy; Mishra, Ajay; Tisminetzky, Mayra; Blanchard, Gary; Gurwitz, Jerry H; Goldberg, Robert J; et al. (2022-07-06)
      Background: In managing older adults with atrial fibrillation (AF), their symptomatology impacts their well-being and may inform treatment decision-making. We examined AF symptom perception, its impact on quality of life (QoL), and its relation to treatment strategies in older adults with AF. Methods: Data were obtained from older adults with AF enrolled in a multicenter study conducted at clinic sites in Massachusetts and Georgia between 2016 and 2018. Participants were stratified into three age groups: 65-74 (youngest-old), 75-84 (middle-old), and ≥85 (oldest). Perception of AF symptoms was assessed by participant self-report during their clinic visit and at study enrollment by the Atrial Fibrillation Effect on Quality-of-Life Questionnaire which assessed cardiac-specific and non-specific, non-cardiac AF symptoms and their impact on QoL. Treatment strategies (rate or rhythm control) utilized were ascertained from electronic medical records. Results: Among the 1184 participants (mean age 75 years, 48% women, 86% Non-Hispanic White), 51% were aged 65-74 years, 36% were 75-84 years, and 13% were ≥ 85 years. The most commonly reported AF symptoms were non-specific, non-cardiac symptoms (fatigue, dyspnea, lightheadedness) with similar prevalence and impact on QoL in all age groups. Cardiac-specific AF symptoms (palpitations, irregular heartbeat, pause in heart activity) were less prevalent, but most commonly reported by the youngest participants (65-74 years), who endorsed considerable impact of these symptoms on their QoL. Overall, those who reported experiencing any AF symptoms during their clinic visit were more likely to have received rhythm compared with rate control (OR: 1.56; 95% CI: 1.18-2.04) with similar findings for all age groups except those aged ≥85 years. Conclusions: Our findings suggest a high prevalence of non-specific, non-cardiac symptoms among older adults with AF and that cardiac-specific AF symptoms may exert considerable impact on their QoL. The presence of any AF symptoms may drive more rhythm control in a majority of older adults.
    • Association between family or peer views towards tobacco use and past 30-day smoking cessation among adults with mental health problems

      Nagawa, Catherine S; Pbert, Lori; Wang, Bo; Cutrona, Sarah L; Davis, Maryann; Lemon, Stephenie C; Sadasivam, Rajani S (2022-07-05)
      Adults with mental health problems have a higher prevalence of cigarette smoking. We examined the association between family or peer views towards tobacco use and past 30-day cessation among adult with mental health conditions who smoke. We used nationally representative data from the Population Assessment of Tobacco and Health Study. We included individuals who currently smoked and reported mental health symptoms over the past year (n = 4201). We used the Global Appraisal of Individual Needs Short Screener questionnaire to assess mental health conditions. Logistic regression models were used to estimate the odds ratios (OR) and 95% confidence intervals (95%CI) in the association between family and peer views towards tobacco use and past 30-day smoking cessation. Compared to participants who had family or peers with negative views towards tobacco use, those with family or peers with neutral or positive views were 32% less likely (adjusted OR: 0.68, 95%CI: 0.51 - 0.93) to report past 30-day smoking cessation. The association between family/peer views towards tobacco use and smoking cessation was statisitcally significant for individuals with symptoms on the both internalizing and externalizing sub-scales (adjusted OR: 0.62, 95%CI: 0.42 - 0.92), but not for those reporting symptoms on a single sub scale. Our findings suggest that having family members or peers who hold neutral or positive views towards tobacco use may deter cessation efforts of people with mental health conditions who smoke. Efforts to modify these views are needed to improve quit rates in people with mental health conditions who smoke.