32 results on '"Pretz, C"'
Search Results
2. Erratum: A comparison of high vs standard tidal volumes in ventilator weaning for individuals with sub-acute spinal cord injuries: a site-specific randomized clinical trial
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Fenton, J J, primary, Warner, M L, additional, Lammertse, D, additional, Charlifue, S, additional, Martinez, L, additional, Dannels-McClure, A, additional, Kreider, S, additional, and Pretz, C, additional
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- 2016
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3. A comparison of high vs standard tidal volumes in ventilator weaning for individuals with sub-acute spinal cord injuries: a site-specific randomized clinical trial
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Fenton, J J, primary, Warner, M L, additional, Lammertse, D, additional, Charlifue, S, additional, Martinez, L, additional, Dannels-McClure, A, additional, Kreider, S, additional, and Pretz, C, additional
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- 2015
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4. Using rasch motor FIM individual growth curves to inform clinical decisions for persons with paraplegia
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Pretz, C R, primary, Kozlowski, A J, additional, Charlifue, S, additional, Chen, Y, additional, and Heinemann, A W, additional
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- 2014
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5. A comparison of high vs standard tidal volumes in ventilator weaning for individuals with sub-acute spinal cord injuries: a site-specific randomized clinical trial
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Fenton, J J, Warner, M L, Lammertse, D, Charlifue, S, Martinez, L, Dannels-McClure, A, Kreider, S, and Pretz, C
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Study design:Prospective, randomized, controlled parallel group trial with single-blinded data analysis.Objectives:To determine the safety and efficacy of higher (20 ml kg−1ideal body weight (IBW)) vs standard (10 ml kg−1IBW) tidal volumes (Vt) for patients with sub-acute traumatic tetraplegia during ventilator weaning using a 14-day (minimum) weaning protocol.Setting:United States regional spinal cord injury treatment center.Methods:Thirty-three ventilator requiring inpatients were randomized to either the higher (Group 1) or the standard (Group 2) Vt protocol. Initially, all patients were ventilated at 10 ml kg−1IBW Vt and 5 cm H2O of PEEP for 72 h. For Group 1, Vt was raised 100 ml kg−1until reaching target Vt of 20 ml kg−1IBW. Group 2 was maintained at Vt of 10 ml kg−1IBW. Plateau pressures were kept at or below 30 cm H2O. Safety outcomes included incidence of adverse events.Results:Because of smaller than expected enrollment, evaluation of efficacy was not possible. Therefore, we report the safety outcomes of 33 study participants. The 16 patients in Group 1 and 17 patients in Group 2 were demographically similar at baseline, except for age. The average age was 39.3 years in Group 1 and 27.2 years in Group 2, (P=0.002). There was no difference in median days to wean: 14.5 days in Group 1 and 14 days in Group 2. The incidence of adverse pulmonary events was similar between groups.Conclusion:Higher tidal volumes can be safely utilized during weaning of patients with tetraplegia from mechanical ventilation using a 14-day weaning protocol.
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- 2016
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6. Healthy at Home for COPD: An Integrated Digital Monitoring, Treatment, and Pulmonary Rehabilitation Intervention.
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O'Connor L, Behar S, Tarrant S, Stamegna P, Pretz C, Shirshac J, Scornavacca T, Wilkie T, Fisher K, Tigas E, Mullen M, Hyder M, Wong S, Savage B, Toomey S, Wang B, Zai A, Alper E, Lindenauer P, Dickson E, Broach J, McManus D, Kheterpal V, and Soni A
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Background: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality in the United States. Frequent exacerbations result in higher use of emergency services and hospitalizations, leading to poor patient outcomes and high costs., Objective: Demonstrate the feasibility of a multimodal, digitally enhanced remote monitoring, treatment, and tele-pulmonary rehabilitation intervention among patients with COPD., Methods: In this pilot clinical trial, community-dwelling adults with moderate-severe COPD were enrolled in a multimodal digital monitoring and treatment program including a Fitbit wearable device, study app that tracked COPD-related symptoms, on-demand mobile integrated health (MIH) services for acute home-based treatment, and tele-pulmonary-rehabilitation. Participants were enrolled in the program for six months. COPD severity and health-related quality of life assessments were performed at baseline, 3 months, and 6 months. Primary feasibility outcomes include recruitment and retention rate, and participant protocol fidelity, which were reported descriptively. Exploratory clinical outcomes included patient-reported quality of life, activation, and intervention satisfaction., Results: Over 18 months, 1,333 patients were approached and 100 (7.5%) were enrolled (mean age 66, 52% female). Ninety-six participants (96%) remained in the study for the full enrollment period. Fifty-five (55%) participated in tele-pulmonary-rehabilitation. Participants wore the Fitbit for a median of 114 days (IQR 183.6) and 16.85 hours/day (4.05), resulting in a median of 1133 minutes (243) per day. Completion rates for scheduled instruments ranged from 78-93%. Nearly all participants (85%) performed COPD ecological momentary assessment at least once with a median of 4.85 recordings. On average, a 2.48-point improvement (p=0.03) in COPD Assessment Test Score was observed from baseline to study completion. The adherence and symptom improvement metrics were not associated with baseline patient activation measures., Conclusions: A multimodal intervention combining preventative care, symptom and biometric monitoring, and home treatment was feasible in adults living with COPD. Participants demonstrated high protocol fidelity and engagement and reported improved quality of life., Competing Interests: Competing Interest Statement: Author VK is a principal and employee of CareEvolution. Author BS is an employee of CareEvolution. Author DDK received sponsored research support from Bristol Myers Squibb, Pfizer, Flexcon, and Boehringer Ingelheim, and has consulted for Bristol Myers Squibb, Pfizer, Fitbit, Heart Rhythm Society, and Flexcon. Author DDM has also received payment to serve on Data Safety Boards for NAMSA, and Avania.
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- 2024
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7. Rationale and design of healthy at home for COPD: an integrated remote patient monitoring and virtual pulmonary rehabilitation pilot study.
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O'Connor L, Behar S, Tarrant S, Stamegna P, Pretz C, Wang B, Savage B, Scornavacca TT, Shirshac J, Wilkie T, Hyder M, Zai A, Toomey S, Mullen M, Fisher K, Tigas E, Wong S, McManus DD, Alper E, Lindenauer PK, Dickson E, Broach J, Kheterpal V, and Soni A
- Abstract
Chronic obstructive pulmonary disease (COPD) is a common, costly, and morbid condition. Pulmonary rehabilitation, close monitoring, and early intervention during acute exacerbations of symptoms represent a comprehensive approach to improve outcomes, but the optimal means of delivering these services is uncertain. Logistical, financial, and social barriers to providing healthcare through face-to-face encounters, paired with recent developments in technology, have stimulated interest in exploring alternative models of care. The Healthy at Home study seeks to determine the feasibility of a multimodal, digitally enhanced intervention provided to participants with COPD longitudinally over 6 months. This paper details the recruitment, methods, and analysis plan for the study, which is recruiting 100 participants in its pilot phase. Participants were provided with several integrated services including a smartwatch to track physiological data, a study app to track symptoms and study instruments, access to a mobile integrated health program for acute clinical needs, and a virtual comprehensive pulmonary support service. Participants shared physiologic, demographic, and symptom reports, electronic health records, and claims data with the study team, facilitating a better understanding of their symptoms and potential care needs longitudinally. The Healthy at Home study seeks to develop a comprehensive digital phenotype of COPD by tracking and responding to multiple indices of disease behavior and facilitating early and nuanced responses to changes in participants' health status. This study is registered at Clinicaltrials.gov (NCT06000696)., (© 2024. The Author(s).)
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- 2024
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8. Performance of and Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostics Based on Symptom Onset and Close Contact Exposure: An Analysis From the Test Us at Home Prospective Cohort Study.
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Herbert C, Wang B, Lin H, Yan Y, Hafer N, Pretz C, Stamegna P, Wright C, Suvarna T, Harman E, Schrader S, Nowak C, Kheterpal V, Orvek E, Wong S, Zai A, Barton B, Gerber BS, Lemon SC, Filippaios A, Gibson L, Greene S, Colubri A, Achenbach C, Murphy R, Heetderks W, Manabe YC, O'Connor L, Fahey N, Luzuriaga K, Broach J, Roth K, McManus DD, and Soni A
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Background: Understanding changes in diagnostic performance after symptom onset and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure within different populations is crucial to guide the use of diagnostics for SARS-CoV-2., Methods: The Test Us at Home study was a longitudinal cohort study that enrolled individuals across the United States between October 2021 and February 2022. Participants performed paired antigen-detection rapid diagnostic tests (Ag-RDTs) and reverse-transcriptase polymerase chain reaction (RT-PCR) tests at home every 48 hours for 15 days and self-reported symptoms and known coronavirus disease 2019 exposures immediately before testing. The percent positivity for Ag-RDTs and RT-PCR tests was calculated each day after symptom onset and exposure and stratified by vaccination status, variant, age category, and sex., Results: The highest percent positivity occurred 2 days after symptom onset (RT-PCR, 91.2%; Ag-RDT, 71.1%) and 6 days after exposure (RT-PCR, 91.8%; Ag-RDT, 86.2%). RT-PCR and Ag-RDT performance did not differ by vaccination status, variant, age category, or sex. The percent positivity for Ag-RDTs was lower among exposed, asymptomatic than among symptomatic individuals (37.5% (95% confidence interval [CI], 13.7%-69.4%) vs 90.3% (75.1%-96.7%). Cumulatively, Ag-RDTs detected 84.9% (95% CI, 78.2%-89.8%) of infections within 4 days of symptom onset. For exposed participants, Ag-RDTs detected 94.0% (95% CI, 86.7%-97.4%) of RT-PCR-confirmed infections within 6 days of exposure., Conclusions: The percent positivity for Ag-RDTs and RT-PCR tests was highest 2 days after symptom onset and 6 days after exposure, and performance increased with serial testing. The percent positivity of Ag-RDTs was lowest among asymptomatic individuals but did not differ by sex, variant, vaccination status, or age category., Competing Interests: Potential conflicts of interest. V. K. is principal and T. S., E. H., S. S., and C. N. and are employees of the healthcare technology company CareEvolution, which was contracted to configure the smart phone study app, provide operational and logistical support, and collaborate on overall research approach. L. G. is on a scientific advisory board for Moderna on projects unrelated to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Y. C. M. has received tests from Quanterix, Becton-Dickinson, Ceres, and Hologic for research-related purposes, consults for Abbott on subjects unrelated to SARS-CoV-2, and receives funding support to Johns Hopkins University from miDiagnostics. K. L. receives research funding from Moderna and has consulted for Gilead. D. D. M. reports consulting and research grants from Bristol-Myers Squibb and Pfizer, consulting and research support from Fitbit, consulting and research support from Flexcon, research grant from Boehringer Ingelheim, consulting support from Avania, nonfinancial research support from Apple Computer, and consulting/other support from Heart Rhythm Society. A. S. receives nonfinancial support from CareEvolution for collaborative research activities. All other authors report no potential conflicts., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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- 2024
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9. Pan-Cancer Prevalence of Microsatellite Instability-High (MSI-H) Identified by Circulating Tumor DNA and Associated Real-World Clinical Outcomes.
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Kasi PM, Bucheit LA, Liao J, Starr J, Barata P, Klempner SJ, Gandara D, Shergill A, Madeira da Silva L, Weipert C, Zhang N, Pretz C, Hardin A, Kiedrowski LA, and Odegaard JI
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- Male, Humans, Microsatellite Instability, Retrospective Studies, Prevalence, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung epidemiology, Carcinoma, Non-Small-Cell Lung genetics, Circulating Tumor DNA genetics, Lung Neoplasms drug therapy
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Purpose: Immune checkpoint inhibitors are approved for advanced solid tumors with microsatellite instability-high (MSI-H). Although several technologies can assess MSI-H status, detection and outcomes with circulating tumor DNA (ctDNA)-detected MSI-H are lacking. As such, we examined pan-cancer MSI-H prevalence across 21 cancers and outcomes after ctDNA-detected MSI-H., Methods: Patients with advanced cancer who had ctDNA testing (Guardant360) from October 1, 2018, to June 30, 2022, were retrospectively assessed for prevalence. GuardantINFORM, which includes anonymized genomic and structured payer claims data, was queried to assess outcomes. Patients who initiated new treatment within 90 days of MSI-H detection were sorted into immunotherapy included in treatment (IO) or no immunotherapy included (non-IO) groups. Real-world time to treatment discontinuation (rwTTD) and real-world time to next treatment (rwTTNT) were assessed in months as proxies of progression-free survival (PFS); real-world overall survival (rwOS) was assessed in months. Cox regression tests analyzed differences. Colorectal cancer, non-small-cell lung cancer (NSCLC), prostate cancer, gastroesophageal cancer, and uterine cancer (UC) were assessed independently; all other cancers were grouped., Results: In total, 1.4% of 171,881 patients had MSI-H detected. Of 770 patients with outcomes available, rwTTD and rwTTNT were significantly longer for patients who received IO compared with non-IO for all cancers ( P ≤ .05; hazard ratio [HR] range, 0.31-0.52 and 0.25-0.54, respectively) except NSCLC. rwOS had limited follow-up for all cohorts except UC (IO 39 v non-IO 23 months; HR, 0.18; P = .004); however, there was a consistent trend toward prolonged OS in IO-treated patients., Conclusion: These data support use of a well-validated ctDNA assay to detect MSI-H across solid tumors and suggest prolonged PFS in patients treated with IO-containing regimens after detection. Tumor-agnostic, ctDNA-based MSI testing may be reliable for rapid decision making.
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- 2023
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10. Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection : A Prospective Cohort Study.
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Soni A, Herbert C, Lin H, Yan Y, Pretz C, Stamegna P, Wang B, Orwig T, Wright C, Tarrant S, Behar S, Suvarna T, Schrader S, Harman E, Nowak C, Kheterpal V, Rao LV, Cashman L, Orvek E, Ayturk D, Gibson L, Zai A, Wong S, Lazar P, Wang Z, Filippaios A, Barton B, Achenbach CJ, Murphy RL, Robinson ML, Manabe YC, Pandey S, Colubri A, O'Connor L, Lemon SC, Fahey N, Luzuriaga KL, Hafer N, Roth K, Lowe T, Stenzel T, Heetderks W, Broach J, and McManus DD
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- Humans, Prospective Studies, SARS-CoV-2, Polymerase Chain Reaction, Cognition, Sensitivity and Specificity, COVID-19 diagnosis
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Background: The performance of rapid antigen tests (Ag-RDTs) for screening asymptomatic and symptomatic persons for SARS-CoV-2 is not well established., Objective: To evaluate the performance of Ag-RDTs for detection of SARS-CoV-2 among symptomatic and asymptomatic participants., Design: This prospective cohort study enrolled participants between October 2021 and January 2022. Participants completed Ag-RDTs and reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 every 48 hours for 15 days., Setting: Participants were enrolled digitally throughout the mainland United States. They self-collected anterior nasal swabs for Ag-RDTs and RT-PCR testing. Nasal swabs for RT-PCR were shipped to a central laboratory, whereas Ag-RDTs were done at home., Participants: Of 7361 participants in the study, 5353 who were asymptomatic and negative for SARS-CoV-2 on study day 1 were eligible. In total, 154 participants had at least 1 positive RT-PCR result., Measurements: The sensitivity of Ag-RDTs was measured on the basis of testing once (same-day), twice (after 48 hours), and thrice (after a total of 96 hours). The analysis was repeated for different days past index PCR positivity (DPIPPs) to approximate real-world scenarios where testing initiation may not always coincide with DPIPP 0. Results were stratified by symptom status., Results: Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDTs twice 48 hours apart resulted in an aggregated sensitivity of 93.4% (95% CI, 90.4% to 95.9%) among symptomatic participants on DPIPPs 0 to 6. When singleton positive results were excluded, the aggregated sensitivity on DPIPPs 0 to 6 for 2-time serial testing among asymptomatic participants was lower at 62.7% (CI, 57.0% to 70.5%), but it improved to 79.0% (CI, 70.1% to 87.4%) with testing 3 times at 48-hour intervals., Limitation: Participants tested every 48 hours; therefore, these data cannot support conclusions about serial testing intervals shorter than 48 hours., Conclusion: The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours., Primary Funding Source: National Institutes of Health RADx Tech program., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M23-0385.
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- 2023
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11. Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection.
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Soni A, Herbert C, Pretz C, Stamegna P, Filippaios A, Shi Q, Suvarna T, Harman E, Schrader S, Nowak C, Schramm E, Kheterpal V, Behar S, Tarrant S, Ferranto J, Hafer N, Robinson M, Achenbach C, Murphy RL, Manabe YC, Gibson L, Barton B, O'Connor L, Fahey N, Orvek E, Lazar P, Ayturk D, Wong S, Zai A, Cashman L, Rao LV, Luzuriaga K, Lemon S, Blodgett A, Trippe E, Barcus M, Goldberg B, Roth K, Stenzel T, Heetderks W, Broach J, and McManus D
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Background: Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals., Methods: This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported., Key Results: A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide., Conclusions: The 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., Competing Interests: VK is principal, and TS, SS, CN, ES, and EH are employees of the health care technology company CareEvolution, which was contracted to configure the smartphone study app, provide operational and logistical support, and collaborate on overall research approach. LS and LR are employees of Quest Diagnostics LLC, which was contracted to provide direct-to-consumer kits, logistical support for nationwide RT-PCR testing, and operational support for producing molecular testing results. DDM reports consulting and research grants from Bristol-Myers Squibb and Pfizer, consulting and research support from Fitbit, consulting, and research support from Flexcon, research grant from Boehringer Ingelheim, consulting from Avania, non-financial research support from Apple Computer, consulting/other support from Heart Rhythm Society. YCM has received tests from Quanterix, Becton-Dickinson, Ceres, and Hologic for research-related purposes, consults for Abbott on subjects unrelated to SARS-CoV-2, and receives funding support to Johns Hopkins University from miDiagnostics. LG is on a scientific advisory board for Moderna on projects unrelated to SARS-CoV-2. AS receives non-financial support from CareEvolution for collaborative research activities. Additional authors declare no financial or nonfinancial competing interests., (© The Author(s) 2023.)
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- 2023
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12. How does a self-incompatible individual transition to self-compatibility during its lifetime?
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Pretz C and Smith SD
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- 2023
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13. Performance of Rapid Antigen Tests Based on Symptom Onset and Close Contact Exposure: A secondary analysis from the Test Us At Home prospective cohort study.
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Herbert C, Wang B, Lin H, Hafer N, Pretz C, Stamegna P, Tarrant S, Hartin P, Ferranto J, Behar S, Wright C, Orwig T, Suvarna T, Harman E, Schrader S, Nowak C, Kheterpal V, Orvek E, Wong S, Zai A, Barton B, Gerber B, Lemon SC, Filippaios A, D'Amore K, Gibson L, Greene S, Howard-Wilson S, Colubri A, Achenbach C, Murphy R, Heetderks W, Manabe YC, O'Connor L, Fahey N, Luzuriaga K, Broach J, McManus DD, and Soni A
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Background: The performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) in temporal relation to symptom onset or exposure is unknown, as is the impact of vaccination on this relationship., Objective: To evaluate the performance of Ag-RDT compared with RT-PCR based on day after symptom onset or exposure in order to decide on 'when to test'., Design Setting and Participants: The Test Us at Home study was a longitudinal cohort study that enrolled participants over 2 years old across the United States between October 18, 2021 and February 4, 2022. All participants were asked to conduct Ag-RDT and RT-PCR testing every 48 hours over a 15-day period. Participants with one or more symptoms during the study period were included in the Day Post Symptom Onset (DPSO) analyses, while those who reported a COVID-19 exposure were included in the Day Post Exposure (DPE) analysis., Exposure: Participants were asked to self-report any symptoms or known exposures to SARS-CoV-2 every 48-hours, immediately prior to conducting Ag-RDT and RT-PCR testing. The first day a participant reported one or more symptoms was termed DPSO 0, and the day of exposure was DPE 0. Vaccination status was self-reported., Main Outcome and Measures: Results of Ag-RDT were self-reported (positive, negative, or invalid) and RT-PCR results were analyzed by a central laboratory. Percent positivity of SARS-CoV-2 and sensitivity of Ag-RDT and RT-PCR by DPSO and DPE were stratified by vaccination status and calculated with 95% confidence intervals., Results: A total of 7,361 participants enrolled in the study. Among them, 2,086 (28.3%) and 546 (7.4%) participants were eligible for the DPSO and DPE analyses, respectively. Unvaccinated participants were nearly twice as likely to test positive for SARS-CoV-2 than vaccinated participants in event of symptoms (PCR+: 27.6% vs 10.1%) or exposure (PCR+: 43.8% vs. 22.2%). The highest proportion of vaccinated and unvaccinated individuals tested positive on DPSO 2 and DPE 5-8. Performance of RT-PCR and Ag-RDT did not differ by vaccination status. Ag-RDT detected 78.0% (95% Confidence Interval: 72.56-82.61) of PCR-confirmed infections by DPSO 4. For exposed participants, Ag-RDT detected 84.9% (95% CI: 75.0-91.4) of PCR-confirmed infections by day five post-exposure (DPE 5)., Conclusions and Relevance: Performance of Ag-RDT and RT-PCR was highest on DPSO 0-2 and DPE 5 and did not differ by vaccination status. These data suggests that serial testing remains integral to enhancing the performance of Ag-RDT.
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- 2023
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14. Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection.
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Soni A, Herbert C, Lin H, Yan Y, Pretz C, Stamegna P, Wang B, Orwig T, Wright C, Tarrant S, Behar S, Suvarna T, Schrader S, Harman E, Nowak C, Kheterpal V, Rao LV, Cashman L, Orvek E, Ayturk D, Gibson L, Zai A, Wong S, Lazar P, Wang Z, Filippaios A, Barton B, Achenbach CJ, Murphy RL, Robinson M, Manabe YC, Pandey S, Colubri A, Oâ Connor L, Lemon SC, Fahey N, Luzuriaga KL, Hafer N, Roth K, Lowe T, Stenzel T, Heetderks W, Broach J, and McManus DD
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Background: Performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance in screening for SARS-CoV-2 is not well established. We aimed to evaluate performance of Ag-RDT for detection of SARS-CoV-2 for symptomatic and asymptomatic participants., Methods: Participants >2 years old across the United States enrolled in the study between October 2021 and February 2022. Participants completed Ag-RDT and molecular testing (RT-PCR) for SARS-CoV-2 every 48 hours for 15 days. This analysis was limited to participants who were asymptomatic and tested negative on their first day of study participation. Onset of infection was defined as the day of first positive RT-PCR result. Sensitivity of Ag-RDT was measured based on testing once, twice (after 48-hours), and thrice (after 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status., Results: In total, 5,609 of 7,361 participants were eligible for this analysis. Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDT twice 48-hours apart resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Excluding singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower at 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with testing three times at 48-hour intervals., Discussion: Performance of Ag-RDT was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.
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- 2023
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15. Finding a Needle in a Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection.
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Soni A, Herbert C, Pretz C, Stamegna P, Filippaios A, Shi Q, Suvarna T, Harman E, Schrader S, Nowak C, Schramm E, Kheterpal V, Behar S, Tarrant S, Ferranto J, Hafer N, Robinson M, Achenbach C, Murphy RL, Manabe YC, Gibson L, Barton B, O'Connor L, Fahey N, Orvek E, Lazar P, Ayturk D, Wong S, Zai A, Cashman L, Rao LV, Luzuriaga K, Lemon S, Blodgett A, Trippe E, Barcus M, Goldberg B, Roth K, Stenzel T, Heetderks W, Broach J, and McManus D
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Background: Rapid antigen tests (Ag-RDT) for SARS-CoV-2 with Emergency Use Authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially., Objective: To describe a novel study design to generate regulatory-quality data to evaluate serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals., Design: Prospective cohort study using a decentralized approach. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days., Setting: Participants throughout the mainland United States were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Ag-RDTs were completed at home, and molecular comparators were shipped to a central laboratory., Participants: Individuals over 2 years old from across the U.S. with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study., Measurements: Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported., Key Results: A total of 7,361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide., Limitations: New, complex workflows required significant operational and data team support. Conclusions: The 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.
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- 2023
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16. Comparison of Rapid Antigen Tests' Performance Between Delta and Omicron Variants of SARS-CoV-2 : A Secondary Analysis From a Serial Home Self-testing Study.
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Soni A, Herbert C, Filippaios A, Broach J, Colubri A, Fahey N, Woods K, Nanavati J, Wright C, Orwig T, Gilliam K, Kheterpal V, Suvarna T, Nowak C, Schrader S, Lin H, O'Connor L, Pretz C, Ayturk D, Orvek E, Flahive J, Lazar P, Shi Q, Achenbach C, Murphy R, Robinson M, Gibson L, Stamegna P, Hafer N, Luzuriaga K, Barton B, Heetderks W, Manabe YC, and McManus D
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- United States, Humans, Prospective Studies, Self-Testing, Sensitivity and Specificity, SARS-CoV-2, COVID-19
- Abstract
Background: It is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants., Objective: To compare the performance of Ag-RDTs in detecting the Delta (B.1.617.2) and Omicron (B.1.1.529) variants of SARS-CoV-2., Design: Secondary analysis of a prospective cohort study that enrolled participants between 18 October 2021 and 24 January 2022. Participants did Ag-RDTs and collected samples for reverse transcriptase polymerase chain reaction (RT-PCR) testing every 48 hours for 15 days., Setting: The parent study enrolled participants throughout the mainland United States through a digital platform. All participants self-collected anterior nasal swabs for rapid antigen testing and RT-PCR testing. All Ag-RDTs were completed at home, whereas nasal swabs for RT-PCR were shipped to a central laboratory., Participants: Of 7349 participants enrolled in the parent study, 5779 asymptomatic persons who tested negative for SARS-CoV-2 on day 1 of the study were eligible for this substudy., Measurements: Sensitivity of Ag-RDTs on the same day as the first positive (index) RT-PCR result and 48 hours after the first positive RT-PCR result., Results: A total of 207 participants were positive on RT-PCR (58 Delta, 149 Omicron). Differences in sensitivity between variants were not statistically significant (same day: Delta, 15.5% [95% CI, 6.2% to 24.8%] vs. Omicron, 22.1% [CI, 15.5% to 28.8%]; at 48 hours: Delta, 44.8% [CI, 32.0% to 57.6%] vs. Omicron, 49.7% [CI, 41.6% to 57.6%]). Among 109 participants who had RT-PCR-positive results for 48 hours, rapid antigen sensitivity did not differ significantly between Delta- and Omicron-infected participants (48-hour sensitivity: Delta, 81.5% [CI, 66.8% to 96.1%] vs. Omicron, 78.0% [CI, 69.1% to 87.0%]). Only 7.2% of the 69 participants with RT-PCR-positive results for shorter than 48 hours tested positive by Ag-RDT within 1 week; those with Delta infections remained consistently negative on Ag-RDTs., Limitation: A testing frequency of 48 hours does not allow a finer temporal resolution of the analysis of test performance, and the results of Ag-RDTs are based on self-report., Conclusion: The performance of Ag-RDTs in persons infected with the SARS-CoV-2 Omicron variant is not inferior to that in persons with Delta infections. Serial testing improved the sensitivity of Ag-RDTs for both variants. The performance of rapid antigen testing varies on the basis of duration of RT-PCR positivity., Primary Funding Source: National Heart, Lung, and Blood Institute of the National Institutes of Health.
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- 2022
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17. Feasibility of At-Home Serial Testing Using Over-the-Counter SARS-CoV-2 Tests With a Digital Smartphone App for Assistance: Longitudinal Cohort Study.
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Herbert C, Broach J, Heetderks W, Qashu F, Gibson L, Pretz C, Woods K, Kheterpal V, Suvarna T, Nowak C, Lazar P, Ayturk D, Barton B, Achenbach C, Murphy R, McManus D, and Soni A
- Abstract
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., (©Carly Herbert, John Broach, William Heetderks, Felicia Qashu, Laura Gibson, Caitlin Pretz, Kelsey Woods, Vik Kheterpal, Thejas Suvarna, Christopher Nowak, Peter Lazar, Didem Ayturk, Bruce Barton, Chad Achenbach, Robert Murphy, David McManus, Apurv Soni. Originally published in JMIR Formative Research (https://formative.jmir.org), 18.10.2022.)
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- 2022
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18. How to approach the study of syndromes in macroevolution and ecology.
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Sinnott-Armstrong MA, Deanna R, Pretz C, Liu S, Harris JC, Dunbar-Wallis A, Smith SD, and Wheeler LC
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Syndromes, wherein multiple traits evolve convergently in response to a shared selective driver, form a central concept in ecology and evolution. Recent work has questioned the existence of some classic syndromes, such as pollination and seed dispersal syndromes. Here, we discuss some of the major issues that have afflicted research into syndromes in macroevolution and ecology. First, correlated evolution of traits and hypothesized selective drivers is often relied on as the only evidence for adaptation of those traits to those hypothesized drivers, without supporting evidence. Second, the selective driver is often inferred from a combination of traits without explicit testing. Third, researchers often measure traits that are easy for humans to observe rather than measuring traits that are suited to testing the hypothesis of adaptation. Finally, species are often chosen for study because of their striking phenotypes, which leads to the illusion of syndromes and divergence. We argue that these issues can be avoided by combining studies of trait variation across entire clades or communities with explicit tests of adaptive hypotheses and that taking this approach will lead to a better understanding of syndrome-like evolution and its drivers., Competing Interests: The authors have no conflicts of interest to declare., (© 2022 The Authors. Ecology and Evolution published by John Wiley & Sons Ltd.)
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- 2022
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19. Comparison of Rapid Antigen Tests' Performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) Variants of SARS-CoV-2: Secondary Analysis from a Serial Home Self-Testing Study.
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Soni A, Herbert C, Filippaios A, Broach J, Colubri A, Fahey N, Woods K, Nanavati J, Wright C, Orwig T, Gilliam K, Kheterpal V, Suvarna T, Nowak C, Schrader S, Lin H, O'Connor L, Pretz C, Ayturk D, Orvek E, Flahive J, Lazar P, Shi Q, Achenbach C, Murphy R, Robinson M, Gibson L, Stamegna P, Hafer N, Luzuriaga K, Barton B, Heetderks W, Manabe YC, and McManus D
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Background: There is a need to understand the performance of rapid antigen tests (Ag-RDT) for detection of the Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) SARS-CoV-2 variants., Methods: Participants without any symptoms were enrolled from October 18, 2021 to January 24, 2022 and performed Ag-RDT and RT-PCR tests every 48 hours for 15 days. This study represents a non-pre-specified analysis in which we sought to determine if sensitivity of Ag-RDT differed in participants with Delta compared to Omicron variant. Participants who were positive on RT-PCR on the first day of the testing period were excluded. Delta and Omicron variants were defined based on sequencing and date of first RT-PCR positive result (RT-PCR+). Comparison of Ag-RDT performance between the variants was based on sensitivity, defined as proportion of participants with Ag-RDT+ results in relation to their first RT-PCR+ result, for different duration of testing with rapid Ag-RDT. Subsample analysis was performed based on the result of participants' second RT-PCR test within 48 hours of the first RT-PCR+ test., Results: From the 7,349 participants enrolled in the parent study, 5,506 met the eligibility criteria for this analysis. A total of 153 participants were RT-PCR+ (61 Delta, 92 Omicron); among this group, 36 (23.5%) tested Ag-RDT+ on the same day, and 84 (54.9%) tested Ag-RDT+ within 48 hours as first RT-PCR+. The differences in sensitivity between variants were not statistically significant (same-day: Delta 16.4% [95% CI: 8.2-28.1] vs Omicron 28.2% [95% CI: 19.4-38.6]; and 48-hours: Delta 45.9% [33.1-59.2] vs. Omicron 60.9% [50.1-70.9]). This trend continued among the 86 participants who had consecutive RT-PCR+ result (48-hour sensitivity: Delta 79.3% [60.3-92.1] vs. Omicron: 89.5% [78.5-96.0]). Conversely, the 38 participants who had an isolated RT-PCR+ remained consistently negative on Ag-RDT, regardless of the variant., Conclusions: The performance of Ag-RDT is not inferior among individuals infected with the SARS-CoV-2 Omicron variant as compared to the Delta variant. The improvement in sensitivity of Ag-RDT noted with serial testing is consistent between Delta and Omicron variant. Performance of Ag-RDT varies based on duration of RT-PCR+ results and more studies are needed to understand the clinical and public health significance of individuals who are RT-PCR+ for less than 48 hours.
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- 2022
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20. Intraspecific breakdown of self-incompatibility in Physalis acutifolia (Solanaceae).
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Pretz C and Smith SD
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Variation in mating systems is prevalent throughout angiosperms, with many transitions between outcrossing and selfing above and below the species level. This study documents a new case of an intraspecific breakdown of self-incompatibility in a wild relative of tomatillo, Physalis acutifolia . We used controlled greenhouse crosses to identify self-incompatible (SI) and self-compatible (SC) individuals grown from seed sampled across seven sites across Arizona and New Mexico. We measured 14 flower and fruit traits to test for trait variation associated with mating system. We also quantified pollen tube growth in vivo and tested for the presence of the S-RNase proteins in SI and SC styles. We found that seed from six of the seven sites produced SI individuals that terminated self-pollen tubes in the style and showed detectable S-RNase expression. By contrast, seed from one Arizona site produced SC individuals with no S-RNase expression. These SC individuals displayed typical selfing-syndrome traits such as smaller corollas, reduced stigma-anther distances, and a smaller pollen-ovule ratio. We also found plasticity in self-incompatibility as most of the SI individuals became SC and lost S-RNase expression roughly after 6 months in the greenhouse. While fixed differences in mating systems are known among the SI wild species and the often SC domesticated tomatillos, our study is the first to demonstrate intraspecific variation in natural populations as well as variation in SI over an individual's lifespan., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Annals of Botany Company.)
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- 2021
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21. Return to Productivity Projections for Individuals With Moderate to Severe TBI Following Inpatient Rehabilitation: A NIDILRR TBIMS and CDC Interagency Collaboration.
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Pretz C, Kowalski RG, Cuthbert JP, Whiteneck GG, Miller AC, Ketchum JM, and Dams-O'Connor K
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- Centers for Disease Control and Prevention, U.S., Cohort Studies, Humans, Inpatients, United States, Brain Injuries, Traumatic diagnosis, Brain Injuries, Traumatic rehabilitation, Return to School, Return to Work
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Objective: Return to work and school following traumatic brain injury (TBI) is an outcome of central importance both to TBI survivors and to society. The current study estimates the probability of returning to productivity over 5 years following moderate to severe brain injury., Design: A secondary longitudinal analysis using random effects modeling, that is, individual growth curve analysis based on a sample of 2542 population-weighted individuals from a multicenter cohort study., Setting: Acute inpatient rehabilitation facilities., Participants: Individuals 16 years and older with a primary diagnosis of TBI who were engaged in school or work at the time of injury., Main Outcome Measures: Participation in productive activity, defined as employment or school, as reported during follow-up telephone interviews at 1, 2, and 5 years postinjury., Results: Baseline variables, age of injury, race, level of education and occupational category at the time of injury, disability rating at hospital discharge, substance abuse status, and rehabilitation length of stay, are significantly associated with probability of return to productivity. Individual-level productivity trajectories generally indicate that the probability of returning to productivity increases over time., Conclusions: Results of this study highlight the importance of preinjury occupational status and level of education in returning to productive activity following moderate to severe TBI.
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- 2020
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22. Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind, placebo-controlled clinical pilot study.
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Ripley DL, Gerber D, Pretz C, Weintraub AH, and Wierman ME
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- Adolescent, Adult, Aged, Double-Blind Method, Humans, Male, Middle Aged, Recovery of Function, Young Adult, Androgens administration & dosage, Androgens adverse effects, Androgens therapeutic use, Brain Injuries, Traumatic complications, Brain Injuries, Traumatic physiopathology, Brain Injuries, Traumatic rehabilitation, Eunuchism drug therapy, Eunuchism etiology, Testosterone administration & dosage, Testosterone adverse effects, Testosterone therapeutic use
- Abstract
Background: Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function., Objective: Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation., Design: Randomized, double blind, placebo-controlled pilot trial., Setting: Inpatient rehabilitation brain injury unit., Participants: Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation., Interventions: Transdermal T gel or placebo., Main Outcome Measures: Revised FIM™ score, strength, adverse events., Results: Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group., Conclusions: Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.
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- 2020
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23. Factors Associated With Rehabilitation Outcomes After Traumatic Brain Injury: Comparing Functional Outcomes Between TBIMS Centers Using Hierarchical Linear Modeling.
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Dahdah MN, Hofmann M, Pretz C, An V, Barnes SA, Bennett M, Dreer LE, Bergquist T, and Shafi S
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- Adult, Brain Injuries, Traumatic physiopathology, Brain Injuries, Traumatic psychology, Cohort Studies, Female, Hospitalization, Humans, Linear Models, Male, Middle Aged, Recovery of Function, Rehabilitation Centers, Treatment Outcome, Young Adult, Brain Injuries, Traumatic rehabilitation
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Objective: To examine differences in patient outcomes across Traumatic Brain Injury Model Systems (TBIMS) rehabilitation centers and factors that influence these differences using hierarchical linear modeling (HLM)., Setting: Sixteen TBIMS centers., Participants: A total of 2056 individuals 16 years or older with moderate to severe traumatic brain injury (TBI) who received inpatient rehabilitation., Design: Multicenter observational cohort study using HLM to analyze prospectively collected data., Main Outcome Measures: Functional Independence Measure and Disability Rating Scale total scores at discharge and 1 year post-TBI., Results: Duration of posttraumatic amnesia (PTA) demonstrated a significant inverse relationship with functional outcomes. However, the magnitude of this relationship (change in functional status for each additional day in PTA) varied among centers. Functional status at discharge from rehabilitation and at 1 year post-TBI could be predicted using the slope and intercept of each TBIMS center for the duration of PTA, by comparing it against the average slope and intercept., Conclusions: HLM demonstrated center effect due to variability in the relationship between PTA and functional outcomes of patients. This variability is not accounted for in traditional linear regression modeling. Future studies examining variations in patient outcomes between centers should utilize HLM to measure the impact of additional factors that influence patient rehabilitation functional outcomes.
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- 2017
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24. Rehospitalization Over 10 Years Among Survivors of TBI: A National Institute on Disability, Independent Living, and Rehabilitation Research Traumatic Brain Injury Model Systems Study.
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Dams-OʼConnor K, Mellick D, Dreer LE, Hammond FM, Hoffman J, Landau A, Zafonte R, and Pretz C
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- Adult, Age Factors, Aged, Brain Injuries, Traumatic diagnosis, Brain Injuries, Traumatic mortality, Cross-Sectional Studies, Female, Follow-Up Studies, Humans, Independent Living, Injury Severity Score, Length of Stay, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Rehabilitation Research, Risk Assessment, Sex Factors, Time Factors, Treatment Outcome, United States, Brain Injuries, Traumatic rehabilitation, Disability Evaluation, Disease Management, Patient Readmission statistics & numerical data, Survivors
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Objective: To describe the rates and causes for rehospitalization over 10 years after moderate-severe traumatic brain injury (TBI), and to characterize longitudinal trajectories of the probability of rehospitalization using generalized linear mixed models and individual growth curve models conditioned on factors that help explain individual variability in rehospitalization risk over time., Design: Secondary analysis of data from a multicenter longitudinal cohort study., Setting: Acute inpatient rehabilitation facilities and community follow-up., Participants: Individuals 16 years and older with a primary diagnosis of TBI., Main Outcome Measures: Rehospitalization (and reason for rehospitalization) as reported by participants or proxy during follow-up telephone interviews at 1, 2, 5, and 10 years postinjury., Results: The greatest number of rehospitalizations occurred in the first year postinjury (27.8% of the sample), and the rates of rehospitalization remained largely stable (22.1%-23.4%) at 2, 5, and 10 years. Reasons for rehospitalization varied over time: Orthopedic and reconstructive surgery rehospitalizations were most common in year 1, whereas general health maintenance was most common by year 2 with rates increasing at each follow-up. Longitudinal models indicate that multiple demographic and injury-related factors are associated with the probability of rehospitalization over time., Conclusions: These findings can inform the content and timing of interventions to improve health and longevity after TBI.
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- 2017
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25. Variations in Inpatient Rehabilitation Functional Outcomes Across Centers in the Traumatic Brain Injury Model Systems Study and the Influence of Demographics and Injury Severity on Patient Outcomes.
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Dahdah MN, Barnes S, Buros A, Dubiel R, Dunklin C, Callender L, Harper C, Wilson A, Diaz-Arrastia R, Bergquist T, Sherer M, Whiteneck G, Pretz C, Vanderploeg RD, and Shafi S
- Subjects
- Adult, Aged, Brain Injuries, Traumatic physiopathology, Comorbidity, Female, Humans, Length of Stay statistics & numerical data, Male, Middle Aged, Sex Factors, Socioeconomic Factors, Time Factors, Trauma Severity Indices, Treatment Outcome, Brain Injuries, Traumatic rehabilitation, Rehabilitation Centers statistics & numerical data
- Abstract
Objective: To compare patient functional outcomes across Traumatic Brain Injury Model Systems (TBIMS) rehabilitation centers using an enhanced statistical model and to determine factors that influence those outcomes., Design: Multicenter observational cohort study., Setting: TBIMS centers., Participants: Patients with traumatic brain injury (TBI) admitted to 19 TBIMS rehabilitation centers from 2003-2012 (N=5505)., Interventions: Not applicable., Main Outcome Measures: Functional outcomes of patients with TBI., Results: Individuals with lower functional status at the time of admission, longer duration of posttraumatic amnesia, and higher burden of medical comorbidities continued to have worse functional outcomes at discharge from inpatient rehabilitation and at the 1-year follow-up, whereas those who were employed at the time of injury had better outcomes at both time periods. Risk-adjusted patient functional outcomes for patients in most TBIMS centers were consistent with previous research. However, there were wide performance differences for a few centers even after using more recently collected data, improving on the regression models by adding predictors known to influence functional outcomes, and using bootstrapping to eliminate confounds., Conclusions: Specific patient, injury, and clinical factors are associated with differences in functional outcomes within and across TBIMS rehabilitation centers. However, these factors did not explain all the variance in patient outcomes, suggesting a role of some other predictors that remain unknown., (Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2016
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26. Quantitative, Image-Based Phenotyping Methods Provide Insight into Spatial and Temporal Dimensions of Plant Disease.
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Mutka AM, Fentress SJ, Sher JW, Berry JC, Pretz C, Nusinow DA, and Bart R
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- Brassica microbiology, Capsicum microbiology, Host-Pathogen Interactions, Solanum lycopersicum microbiology, Manihot microbiology, Mutation, Phenotype, Plant Leaves microbiology, Plants classification, Reproducibility of Results, Spatial Analysis, Viral Proteins genetics, Virulence genetics, Xanthomonas classification, Xanthomonas genetics, Luminescent Measurements methods, Plant Diseases microbiology, Plant Vascular Bundle microbiology, Plants microbiology, Xanthomonas pathogenicity
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Plant disease symptoms exhibit complex spatial and temporal patterns that are challenging to quantify. Image-based phenotyping approaches enable multidimensional characterization of host-microbe interactions and are well suited to capture spatial and temporal data that are key to understanding disease progression. We applied image-based methods to investigate cassava bacterial blight, which is caused by the pathogen Xanthomonas axonopodis pv. manihotis (Xam). We generated Xam strains in which individual predicted type III effector (T3E) genes were mutated and applied multiple imaging approaches to investigate the role of these proteins in bacterial virulence. Specifically, we quantified bacterial populations, water-soaking disease symptoms, and pathogen spread from the site of inoculation over time for strains with mutations in avrBs2, xopX, and xopK as compared to wild-type Xam ∆avrBs2 and ∆xopX both showed reduced growth in planta and delayed spread through the vasculature system of cassava. ∆avrBs2 exhibited reduced water-soaking symptoms at the site of inoculation. In contrast, ∆xopK exhibited enhanced induction of disease symptoms at the site of inoculation but reduced spread through the vasculature. Our results highlight the importance of adopting a multipronged approach to plant disease phenotyping to more fully understand the roles of T3Es in virulence. Finally, we demonstrate that the approaches used in this study can be extended to many host-microbe systems and increase the dimensions of phenotype that can be explored., (© 2016 American Society of Plant Biologists. All Rights Reserved.)
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- 2016
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27. Initial validation of personal self-advocacy measures for individuals with acquired brain injury.
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Hawley L, Gerber D, Pretz C, Morey C, and Whiteneck G
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- Adult, Aged, Assertiveness, Communication, Community Integration, Culture, Female, Health Services Needs and Demand legislation & jurisprudence, Humans, Male, Middle Aged, Outcome Assessment, Health Care, Reproducibility of Results, Young Adult, Brain Injury, Chronic psychology, Brain Injury, Chronic rehabilitation, Health Services Accessibility legislation & jurisprudence, Patient Advocacy legislation & jurisprudence, Patient Advocacy psychology, Psychometrics statistics & numerical data, Self Efficacy, Surveys and Questionnaires
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Purpose/objective: The purpose of this study was to evaluate the psychometric properties of 2 novel measures assessing personal advocacy, self-efficacy and personal advocacy activities in individuals with acquired brain injury (ABI)., Design: This was an instrument development study using (a) expert panel review with a content validity index, (b) consumer survey, and (c) Rasch analysis. Participants were adults (N = 162) with ABI recruited through a community survey., Main Outcome Measure: Participants completed the Self-Advocacy Scale (SAS) and the Personal Advocacy Activity Scale (PAAS)., Results: Using Rasch analysis to inform instrument development, after modification on the basis of item response theory analysis, the SAS, a measure of advocacy self-efficacy, was found to be unidimensional with an eigenvalue of 1.6, exhibited monotonicity, and had an item reliability of 0.97. Similarly, the PAAS, a measure of advocacy activity, was found to exhibit monotonicity, is unidimensional (eigenvalue of 1.7) and had an item reliability of 0.97. Both measures demonstrated concurrent validity, because they were significantly correlated with other established measures of related constructs and with each other. A separation reliability of 0.97 (real not model) for both the SAS and PAAS suggests that items will likely hold their relative positions in a similar sample., Conclusions: This study supported the PAAS and the SAS as reliable and valid measures of personal advocacy activity and associated self-efficacy in individuals post-ABI. (PsycINFO Database Record, ((c) 2016 APA, all rights reserved).)
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- 2016
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28. Life Expectancy after Inpatient Rehabilitation for Traumatic Brain Injury in the United States.
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Harrison-Felix C, Pretz C, Hammond FM, Cuthbert JP, Bell J, Corrigan J, Miller AC, and Haarbauer-Krupa J
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- Adolescent, Adult, Aged, Cause of Death, Databases, Factual, Female, Humans, Inpatients, Male, Middle Aged, Risk Factors, United States epidemiology, Young Adult, Brain Injuries mortality, Brain Injuries rehabilitation, Life Expectancy
- Abstract
This study characterized life expectancy after traumatic brain injury (TBI). The TBI Model Systems (TBIMS) National Database (NDB) was weighted to represent those ≥16 years of age completing inpatient rehabilitation for TBI in the United States (US) between 2001 and 2010. Analyses included Standardized Mortality Ratios (SMRs), Cox regression, and life expectancy. The US mortality rates by age, sex, race, and cause of death for 2005 and 2010 were used for comparison purposes. Results indicated that a total of 1325 deaths occurred in the weighted cohort of 6913 individuals. Individuals with TBI were 2.23 times more likely to die than individuals of comparable age, sex, and race in the general population, with a reduced average life expectancy of 9 years. Independent risk factors for death were: older age, male gender, less-than-high school education, previously married at injury, not employed at injury, more recent year of injury, fall-related TBI, not discharged home after rehabilitation, less functional independence, and greater disability. Individuals with TBI were at greatest risk of death from seizures; accidental poisonings; sepsis; aspiration pneumonia; respiratory, mental/behavioral, or nervous system conditions; and other external causes of injury and poisoning, compared with individuals in the general population of similar age, gender, and race. This study confirms prior life expectancy study findings, and provides evidence that the TBIMS NDB is representative of the larger population of adults receiving inpatient rehabilitation for TBI in the US. There is an increased risk of death for individuals with TBI requiring inpatient rehabilitation.
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- 2015
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29. Global Outcome Trajectories After TBI Among Survivors and Nonsurvivors: A National Institute on Disability and Rehabilitation Research Traumatic Brain Injury Model Systems Study.
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Dams-OʼConnor K, Pretz C, Billah T, Hammond FM, and Harrison-Felix C
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- Adolescent, Adult, Age Factors, Aged, Cohort Studies, Disability Evaluation, Female, Glasgow Outcome Scale, Humans, Male, Middle Aged, Outcome Assessment, Health Care, Recovery of Function, Rehabilitation Research, Survival Analysis, Young Adult, Brain Injuries mortality, Brain Injuries rehabilitation
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Objective: To compare long-term functional outcome trajectories of individuals with traumatic brain injury (TBI) who survive with those who expire more than 5 years postinjury, using individual growth curve analysis., Design: Secondary analysis of data from a multicenter longitudinal cohort study., Setting: Acute inpatient rehabilitation facilities that are current or former TBI Model Systems., Participants: Individuals 16 years and older with a primary diagnosis of TBI., Main Outcome Measures: Glasgow Outcome Scale-Extended; Disability Rating Scale., Results: Individuals in the TBI Model Systems who expire several years after injury demonstrate worse functional status at baseline and a steeper rate of decline over time as measured by both the Glasgow Outcome Scale-Extended and the Disability Rating Scale. There was significant variability in each growth parameter (P < .05) for both instruments. A reduced model was built for each outcome, including all covariates that related significantly to the growth parameters. An interactive tool was created for each outcome to generate individual-level trajectories based on various combinations of covariate values., Conclusion: Individuals with TBI who die several years after injury demonstrate functional trajectories that differ markedly from those of survivors. Opportunities should be sought for health management interventions to improve health and longevity after TBI.
- Published
- 2015
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30. A health and wellness intervention for those with moderate to severe traumatic brain injury: a randomized controlled trial.
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Brenner LA, Braden CA, Bates M, Chase T, Hancock C, Harrison-Felix C, Hawley L, Morey C, Newman J, Pretz C, and Staniszewski K
- Subjects
- Adolescent, Adult, Aged, Female, Health Status Indicators, Humans, Life Style, Male, Middle Aged, Social Support, Surveys and Questionnaires, Young Adult, Brain Injuries rehabilitation, Disabled Persons rehabilitation, Health Behavior, Health Promotion
- Abstract
Objectives: To assess the efficacy of a standardized 12-week health and wellness group intervention for those with moderate to severe traumatic brain injury (TBI)., Study Design: Randomized controlled trial., Participants: Seventy-four individuals with moderate to severe TBI recruited from the outpatient program at a rehabilitation hospital, a Veterans Affairs Medical Center, and the community., Method: Eligible participants were randomized to treatment (health and wellness therapy group) or wait-list control (treatment, n = 37; wait-list, n = 37). The primary outcome was the Health Promoting Lifestyle Profile-II., Results: The results of the mixed-model repeated-measures analysis indicated no differences between treatment and control groups engaging in activities to increase their health and well-being., Conclusions: Findings did not support the efficacy of the intervention. Results may have been impacted by the wide variability of individualized health and wellness goals selected by group members, the structure and/or content of the group, and/or the outcome measures selected.
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- 2012
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31. A longitudinal study of major and minor depression following traumatic brain injury.
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Hart T, Hoffman JM, Pretz C, Kennedy R, Clark AN, and Brenner LA
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- Adult, Age Factors, Brain Injuries epidemiology, Depression epidemiology, Depression psychology, Depressive Disorder epidemiology, Depressive Disorder psychology, Female, Humans, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Sex, Social Support, Socioeconomic Factors, Time Factors, Brain Injuries complications, Brain Injuries psychology, Depression etiology, Depressive Disorder etiology
- Abstract
Objective: To examine patterns of change and factors associated with change in depression, both major (major depressive disorder [MDD]) and minor, between 1 and 2 years after traumatic brain injury (TBI)., Design: Observational prospective longitudinal study., Setting: Inpatient rehabilitation centers, with 1- and 2-year follow-up conducted primarily by telephone., Participants: Persons with TBI (N=1089) enrolled in the Traumatic Brain Injury Model Systems database, followed at 1 and 2 years postinjury., Interventions: Not applicable., Main Outcome Measure: Patient Health Questionnaire-9., Results: Among participants not depressed at 1 year, close to three fourths remained so at 2-year follow-up. However, 26% developed MDD or minor depression between the first and second years postinjury. Over half of participants with MDD at year 1 also reported MDD the following year, with another 22% reporting minor depression; thus three fourths of those with MDD at year 1 experienced clinically significant symptoms at year 2. Almost one third of those with minor depression at year 1 traversed to MDD at year 2. Polytomous logistic regression confirmed that worse depression at year 1 was associated with higher odds of depression a year later. For those without depression at year 1, symptom worsening over time was related to year 2 problematic substance use and lower FIM motor and cognitive scores. For those with depression at year 1, worsening was associated with lower cognitive FIM, poor social support, and preinjury mental health issues including substance abuse., Conclusions: Major and minor depression exist on a continuum along which individuals with TBI may traverse over time. Predictors of change differ according to symptom onset. Results highlight importance of long-term monitoring for depression, treating minor as well as major depression, and developing interventions for comorbid depression and substance abuse., (Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)
- Published
- 2012
- Full Text
- View/download PDF
32. Use of neighborhood characteristics to improve prediction of psychosocial outcomes: a traumatic brain injury model systems investigation.
- Author
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Corrigan JD, Bogner J, Pretz C, Mellick D, Kreider S, Whiteneck GG, Harrison-Felix C, Dijkers MP, and Heinemann AW
- Subjects
- Adult, Brain Injuries epidemiology, Cross-Sectional Studies, Female, Glasgow Outcome Scale, Humans, Male, Middle Aged, Personal Satisfaction, Social Environment, Socioeconomic Factors, Time Factors, Brain Injuries psychology, Models, Psychological, Residence Characteristics statistics & numerical data
- Abstract
Objective: To determine whether use of neighborhood characteristics derived from U.S. Census Bureau information contributes to the prediction of outcomes after traumatic brain injury (TBI) beyond the variance accounted for by individual characteristics., Design: Cross-sectional analysis of follow-up interviews conducted 1, 2, and 5 years postinjury., Setting: Twelve Traumatic Brain Injury Model Systems (TBIMS) centers., Participants: Patients 16 years of age and older with moderate or severe TBI enrolled in the TBIMS National Database (N=472)., Interventions: None., Main Outcome Measures: Satisfaction With Life Scale and Participation Assessment with Recombined Tools-Objective., Results: Individual characteristics alone accounted for 26% and 48% of variance in life satisfaction and participation, respectively; neighborhood characteristics alone accounted for 6% and 9% of variance, respectively. Models combining both types of characteristics included significant neighborhood and individual predictors for participation but not life satisfaction; however, for participation, prediction only improved beyond that found for individual characteristics alone by 1.2%., Conclusions: The results did not support the hypotheses that characteristics of a person's neighborhood would increase outcome prediction beyond that which can be accomplished based on characteristics of the individual alone. Though neighborhood characteristics were statistically significant in prediction models, the improvement in percent of variance accounted for was negligible. Refinements in conceptualization and methodology are suggested for continued exploration of the contribution of neighborhood characteristics to TBI outcomes., (Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)
- Published
- 2012
- Full Text
- View/download PDF
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