Publications by authors named "Ann Johnson"

The field of digital therapeutics (DTx), software programs that prevent, manage, and treat medical conditions, continues to grow. DTx offers new treatment options and has the potential to close gaps in care caused by unmet patient needs, provider shortages, or socioeconomic or geographical disparities. However, the field of DTx has not seen steady adoption owing to barriers, particularly related to coverage, payer acceptance of the category, provider use, and integration within existing health care delivery tools.

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Identifying case-finding strategies to reduce tuberculosis (TB) incidence in high-burden countries requires better knowledge of the disease burden in key contributing populations and settings. To inform South Africa's National Tuberculosis Strategic Plan 2023-2028, we conducted a systematic review of active TB disease and latent TB infection (LTBI) prevalence and incidence in underserved populations, defined as those living in informal settlements, townships, or impoverished communities. We identified articles published from January 2010 to December 2023, assessed study quality, and conducted a meta-analysis to estimate pooled TB and LTBI prevalence stratified by HIV status.

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Background: Clinical practice guidelines recommend adjuvant therapy for patients with early non-small cell lung cancer (eNSCLC), especially those with lymph node metastasis. This study evaluated the prevalence of lymph node examination and its association with adjuvant treatment rates, overall survival (OS), and healthcare costs among United States (US) Medicare patients with resected eNSCLC.

Methods: This retrospective observational cohort study used Surveillance, Epidemiology, and End Results cancer registry data linked with Medicare claims data.

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Purpose: Real-world lung cancer data in administrative claims databases often lack staging information and specific diagnostic codes for lung cancer histology subtypes. This study updates and validates Turner's 2017 treatment-based algorithm using more recent claims and electronic health record (EHR) data.

Methods: This study used Optum's deidentified Market Clarity Data of linked medical and pharmacy claims with EHR data.

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Aim: This study aimed to evaluate the demineralizing effect of commonly used pediatric syrup formulations on primary teeth and the efficacy of two readily available remineralizing agents in treating this effect.

Materials And Methods: Ninety primary teeth were used for sample preparation and divided into three groups: antibiotic syrup (group A), cough syrup (group B), and control (group C) groups. These groups were further categorized into intragroups according to the treatment with remineralizing agents: groups A1, B1, and C1 received GC Tooth Mousse (casein phosphopeptide-amorphous calcium phosphate, CPP-ACP paste) and groups A2, B2, and C2 received Clinpro Tooth Crème.

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Introduction: Pathologic response (PathR) by histopathologic assessment of resected specimens may be an early clinical end point associated with long-term outcomes with neoadjuvant therapy. Digital pathology may improve the efficiency and precision of PathR assessment. LCMC3 (NCT02927301) evaluated neoadjuvant atezolizumab in patients with resectable NSCLC and reported a 20% major PathR rate.

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Importance: Older adults are increasingly prescribed medications that have adverse effects. Prior studies have found a higher risk of motor vehicle crashes to be associated with certain medication use.

Objective: To determine whether specific medication classes were associated with performance decline as assessed by a standardized road test in a community sample of cognitively healthy older adults, to evaluate additional associations of poor road test performance with comorbid medical conditions and demographic characteristics, and to test the hypothesis that specific medication classes (ie, antidepressants, benzodiazepines, sedatives or hypnotics, anticholinergics, antihistamines, and nonsteroidal anti-inflammatory drugs or acetaminophen) would be associated with an increase in risk of impaired driving performance over time.

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Objectives: To investigate the effect of neuropsychiatric symptoms and depression symptoms, respectively, and Alzheimer disease (AD) biomarkers (cerebrospinal fluid [CSF] or Positron Emission Tomography [PET] imaging) on the progression to incident cognitive impairment among cognitively normal older adults.

Design: Prospective, observation, longitudinal study.

Setting: Knight Alzheimer Disease Research Center (ADRC) at Washington University School of Medicine.

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Article Synopsis
  • * The Consortium to Advance Effective Research Ethics Oversight (AEREO) was established in 2018 to tackle this issue by exploring and implementing methods to evaluate IRB effectiveness.
  • * AEREO emphasizes that IRBs should prioritize participant perspectives, ensure reasonable decision-making amid ethical disagreements, and incorporate diverse viewpoints in their processes to enhance accountability and public trust.
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Aims: The purpose of the study was to increase the body of knowledge related to sleep in children with autism. The specific aims were to (i) identify the subgroup of children with autism, ages 3-17 years, referred for polysomnography and (ii) describe types and frequency of clinical encounters for sleep problems in a sample of children ages 3-17 with and without the diagnosis of autism.

Methods: The authors performed a secondary data analysis of the de-identified Nationwide Children's Hospital Sleep DataBank, a collection of encounters with children referred for polysomnography.

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Atezolizumab improved disease-free survival (DFS) versus best supportive care (BSC) as adjuvant treatment following resection and platinum-based chemotherapy for stage II-IIIA PD-L1+ NSCLC in IMpower010. This cost-effectiveness study evaluated atezolizumab versus BSC (US commercial payer perspective) using a Markov model with DFS, locoregional recurrence, first- and second-line metastatic recurrence and death health states, and a lifetime time horizon with 3% annual discounting. Atezolizumab provided 1.

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Introduction: Patients with early NSCLC (eNSCLC) who experience recurrence are associated with worse survival outcomes, but the economic burden of recurrence is not well characterized. This study evaluated the incremental health care resource utilization and costs of recurrence in Medicare patients with resected eNSCLC.

Methods: This retrospective observational study used Surveillance, Epidemiology, and End Results cancer registry data linked with Medicare claims.

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Background: Cerebral small vessel disease (CSVD) as measured by cortical atrophy and white matter hyperintensities [leukoaraiosis], captured via magnetic resonance imaging (MRI) are increasing in prevalence due to the growth of the aging population and an increase in cardiovascular risk factors in the population. CSVD impacts cognitive function and mobility, but it is unclear if it affects complex, functional activities like driving.

Methods: In a cohort of 163 cognitively normal, community-dwelling older adults (age ≥ 65), we compared naturalistic driving behavior with mild/moderate leukoaraiosis, cortical atrophy, or their combined rating in a clinical composite termed, aging-related changes to those without any, over a two-and-a-half-year period.

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Article Synopsis
  • The study investigates the connection between everyday driving behavior and blood-based biomarkers for Alzheimer's disease (AD) using artificial intelligence methods.
  • Researchers utilized artificial neural networks to analyze driving habits alongside plasma Aβ42/Aβ40 levels to assess amyloid positivity among cognitively normal participants.
  • Results indicate that driving behavior, combined with factors like age and APOE ɛ4 status, significantly improves the predictive ability for early detection of AD, highlighting its potential as a viable digital marker for the disease.
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Objective: Adjuvant atezolizumab is a standard of care after chemotherapy in completely resected stage II-IIIA programmed death ligand-1 tumor cell 1% or greater non-small cell lung cancer based on results from the phase III IMpower010 study. We explored the safety and tolerability of adjuvant atezolizumab by surgery type in IMpower010.

Methods: Patients had completely resected stage IB-IIIA non-small cell lung cancer (Union Internationale Contre le Cancer/American Joint Committee on Cancer, 7th Ed), received up to four 21-day cycles of cisplatin-based chemotherapy, and were randomized 1:1 to receive atezolizumab 1200 mg every 3 weeks (≤16 cycles or 1 year) or best supportive care.

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This study investigated real-world treatment patterns and overall survival (OS) in early non-small-cell lung cancer patients and the association between OS and time-to-adjuvant-treatment. This retrospective study using Surveillance, Epidemiology and End Results data linked with Medicare claims included resected early non-small-cell lung cancer patients between 2010 and 2015. Unadjusted OS analyses used Kaplan-Meier curves; adjusted OS analyses used extended Cox proportional hazards models.

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Article Synopsis
  • Daily driving is a complex task that involves various cognitive skills, and it becomes more challenging for older adults as cognitive decline occurs.
  • As the elderly population grows, there is a rise in car accidents among this group, which can be linked to their cognitive health.
  • The study found that older adults with lower cognitive and brain reserves were more likely to change their driving habits, such as reducing driving frequency and avoiding high-risk routes, as they age.
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Introduction: We investigated the relationship between preclinical Alzheimer's disease (AD) biomarkers and adverse driving behaviors in a longitudinal analysis of naturalistic driving data.

Methods: Naturalistic driving data collected using in-vehicle dataloggers from 137 community-dwelling older adults (65+) were used to model driving behavior over time. Cerebrospinal fluid (CSF) biomarkers were used to identify individuals with preclinical AD.

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Objective: Multimodality treatment for resectable non-small cell lung cancer has long remained at a therapeutic plateau. Immune checkpoint inhibitors are highly effective in advanced non-small cell lung cancer and promising preoperatively in small clinical trials for resectable non-small cell lung cancer. This large multicenter trial tested the safety and efficacy of neoadjuvant atezolizumab and surgery.

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Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center assisted the Collaborative Pediatric Critical Care Research Network to transition from using individually negotiated reliance agreements and paper-based documentation to a new sIRB master agreement and an informatics platform to capture reliance documentation. Lessons learned that can guide other academic institutions and IRBs as they operationalize sIRBs included the need for sites to understand what type of engagement or reliance is required and their need to understand the difference between reliance and activation.

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There is growing interest for research ethics professionals to engage with members of the public, yet they often lack the training needed to engage effectively. The STEM Ambassador Program provides a promising framework for training research ethics professionals to form authentic community connections and carry out effective engagement activities based on shared interests and values. The experiences of ten research administrators who participated in a pilot of the STEM Ambassador training for research ethics professionals are presented.

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In an ongoing, open-label, single-arm phase II study ( NCT02927301 ), 181 patients with untreated, resectable, stage IB-IIIB non-small cell lung cancer received two doses of neoadjuvant atezolizumab monotherapy. The primary end point was major pathological response (MPR; ≤10% viable malignant cells) in resected tumors without EGFR or ALK alterations. Of the 143 patients in the primary end point analysis, the MPR was 20% (95% confidence interval, 14-28%).

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Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.

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