46 results on '"Tyler G. Kinzy"'
Search Results
2. Statistical driver genes as a means to uncover missing heritability for age-related macular degeneration
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Andrea R. Waksmunski, Michelle Grunin, Tyler G. Kinzy, Robert P. Igo, Jonathan L. Haines, and Jessica N. Cooke Bailey
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Genome-wide association study ,Pathway analysis ,Statistical driver gene ,GREML ,Heritability ,Internal medicine ,RC31-1245 ,Genetics ,QH426-470 - Abstract
Abstract Background Age-related macular degeneration (AMD) is a progressive retinal disease contributing to blindness worldwide. Multiple estimates for AMD heritability (h 2 ) exist; however, a substantial proportion of h 2 is not attributable to known genomic loci. The International AMD Genomics Consortium (IAMDGC) gathered the largest dataset of advanced AMD (ADV) cases and controls available and identified 34 loci containing 52 independent risk variants defining known AMD h 2 . To better define AMD heterogeneity, we used Pathway Analysis by Randomization Incorporating Structure (PARIS) on the IAMDGC data and identified 8 statistical driver genes (SDGs), including 2 novel SDGs not discovered by the IAMDGC. We chose to further investigate these pathway-based risk genes and determine their contribution to ADV h 2 , as well as the differential ADV subtype h 2 . Methods We performed genomic-relatedness-based restricted maximum-likelihood (GREML) analyses on ADV, geographic atrophy (GA), and choroidal neovascularization (CNV) subtypes to investigate the h 2 of genotyped variants on the full DNA array chip, 34 risk loci (n = 2758 common variants), 52 variants from the IAMDGC 2016 GWAS, and the 8 SDGs, specifically the novel 2 SDGs, PPARA and PLCG2. Results Via GREML, full chip h 2 was 44.05% for ADV, 46.37% for GA, and 62.03% for CNV. The lead 52 variants’ h 2 (ADV: 14.52%, GA: 8.02%, CNV: 13.62%) and 34 loci h 2 (ADV: 13.73%, GA: 8.81%, CNV: 12.89%) indicate that known variants contribute ~ 14% to ADV h 2 . SDG variants account for a small percentage of ADV, GA, and CNV heritability, but estimates based on the combination of SDGs and the 34 known loci are similar to those calculated for known loci alone. We identified modest epistatic interactions among variants in the 2 SDGs and the 52 IAMDGC variants, including modest interactions between variants in PPARA and PLCG2. Conclusions Pathway analyses, which leverage biological relationships among genes in a pathway, may be useful in identifying additional loci that contribute to the heritability of complex disorders in a non-additive manner. Heritability analyses of these loci, especially amongst disease subtypes, may provide clues to the importance of specific genes to the genetic architecture of AMD.
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- 2020
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3. Prehospital Lactate Measurement by Emergency Medical Services in Patients Meeting Sepsis Criteria
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Lori L. Boland, Jonathan S. Hokanson, Karl M. Fernstrom, Tyler G. Kinzy, Charles J. Lick, Paul A. Satterlee, and Brian K. LaCroix
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lactate measurement ,sepsis criteria ,Medicine ,Medical emergencies. Critical care. Intensive care. First aid ,RC86-88.9 - Abstract
Introduction: We aimed to pilot test the delivery of sepsis education to emergency medical services (EMS) providers and the feasibility of equipping them with temporal artery thermometers (TATs) and handheld lactate meters to aid in the prehospital recognition of sepsis. Methods: This study used a convenience sample of prehospital patients meeting established criteria for sepsis. Paramedics received education on systemic inflammatory response syndrome (SIRS) criteria, were trained in the use of TATs and hand-held lactate meters, and enrolled patients who had a recent history of infection, met ≥ 2 SIRS criteria, and were being transported to a participating hospital. Blood lactate was measured by paramedics in the prehospital setting and again in the emergency department (ED) via usual care. Paramedics entered data using an online database accessible at the point of care. Results: Prehospital lactate values obtained by paramedics ranged from 0.8 to 9.8 mmol/L, and an elevated lactate (i.e. ≥ 4.0) was documented in 13 of 112 enrolled patients (12%). The unadjusted correlation of prehospital and ED lactate values was 0.57 (p< 0.001). The median interval between paramedic assessment of blood lactate and the electronic posting of the ED-measured lactate value in the hospital record was 111 minutes. Overall, 91 patients (81%) were hospitalized after ED evaluation, 27 (24%) were ultimately diagnosed with sepsis, and 3 (3%) died during hospitalization. Subjects with elevated prehospital lactate were somewhat more likely to have been admitted to the intensive care unit (23% vs 15%) and to have been diagnosed with sepsis (38% vs 22%) than those with normal lactate levels, but these differences were not statistically significant. Conclusion: In this pilot, EMS use of a combination of objective SIRS criteria, subjective assessment of infection, and blood lactate measurements did not achieve a level of diagnostic accuracy for sepsis that would warrant hospital prenotification and committed resources at a receiving hospital based on EMS assessment alone. Nevertheless, this work provides an early model for increasing EMS awareness and the implementation of novel devices that may enhance the prehospital assessment for sepsis. Additional translational research studies with larger numbers of patients and more robust methods are needed.
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- 2016
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4. Burnout and Exposure to Critical Incidents in a Cohort of Emergency Medical Services Workers from Minnesota
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Lori L. Boland, Tyler G. Kinzy, Russell N. Myers, Karl M. Fernstrom, Jonathan W. Kamrud, Pamela J. Mink, and Andrew C. Stevens
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Medicine ,Medical emergencies. Critical care. Intensive care. First aid ,RC86-88.9 - Abstract
Introduction: Very little quantitative data on occupational burnout and exposure to critical incidents are available from contemporary United States emergency medical services (EMS) cohorts. Given that burnout has been associated positively with turnover intentions and absenteeism in EMS workers, studies that uncover correlates of burnout may be integral to combating growing concerns around retention in the profession. Methods: We administered a 167-item electronic survey that included the Maslach Burnout Inventory (MBI) and a modified version of the Critical Incident History Questionnaire (n=29 incident types) to paramedics, emergency medical technicians (EMTs), and dispatchers of a single ambulance service. We defined the presence of burnout as a high score on either the emotional exhaustion or depersonalization subscales of the MBI. Results: Survey respondents who provided regular 911 response at the time of the survey and completed the MBI portion of the survey were included in our analysis (190 paramedics/EMTs, 19 dispatchers; 54% response). The overall prevalence of burnout was 18%, with prevalence reaching 32% among dispatchers. The seven pediatric critical incident types presented in the survey accounted for seven of the top eight rated most difficult to cope with, and severity ratings for pediatric critical incidents did not differ by parental status (all p>0.30). A significant number of respondents reported that they had been threatened with a gun/weapon (43%) or assaulted by a patient (68%) at least once while on duty. Being over the age of 50, a parent, or in a committed relationship was associated with reduced odds of burnout in unadjusted models; however, these associations did not remain statistically significant in multivariate analysis. Increasing tertile of career exposure to critical incidents was not associated with burnout. Conclusion: Medical dispatchers may be an EMS subgroup particularly susceptible to burnout. These data also demonstrate quantitatively that in this EMS agency, responders find pediatric critical incidents especially distressing and that violence against responders is commonplace. In this study, a simple measure of career exposure to potentially critical incidents was not associated with burnout; however, individual reactions to incidents are heterogeneous, and assessment tools that more accurately enumerate encounters that result in distress are needed.
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- 2018
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5. 3354 Biomedical Informatics/Health Informatics A Preliminary Study of Glaucoma: The Intersection of Genetics and Survey Data from the Health and Retirement Study
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Jessica Cooke Bailey, Tyler G. Kinzy, and Nicholas K. Schiltz
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Medicine - Abstract
OBJECTIVES/SPECIFIC AIMS: Glaucoma is a leading cause of irreversible blindness worldwide; in the United States alone, over 2.7 million individuals are affected. Various risk factors for glaucoma are known and include age, race/ethnicity, genetics, and ocular measures. Despite numerous studies, molecular and environmental factors that contribute to glaucoma remain elusive. Our objective was to conduct a genome-wide association for glaucoma among black and white HRS respondents, and to determine the feasibility for future analyses examining shared genetic markers between glaucoma and other comorbidities, behaviors, and environmental risk factors. METHODS/STUDY POPULATION: The University of Michigan Health and Retirement Study (HRS) is a longitudinal survey of a representative sample of Americans over the age of 50. Supported by the National Institute on Aging and the Social Security Administration, the HRS is designed to provide reliable data on the decisions, choices, and behaviors of people as they age and respond to changes in public policy, the economy, and health. The study obtains information every two years about income and wealth, health and use of health services, work and retirement, and family connections. Through its unique and in-depth interviews, the HRS provides an invaluable and growing body of multidisciplinary data that researchers can use to address important questions about the challenges and opportunities of aging. Because of its innovation and importance, the HRS has become the model and hub for a growing network of harmonized longitudinal aging studies around the world. Saliva was collected on half of the HRS sample each wave starting in 2006 and respondents were genotyped on the Illumina Human Omni2.5-Quad (Omni2.5) BeadChip at the NIH Center for Inherited Disease Research. We accessed survey results to evaluate prevalence of glaucoma in this dataset and performed a genome-wide association study (GWAS) adjusting for age, sex, and significant Principal Components and stratifying by self-reported race (White / Black). RESULTS/ANTICIPATED RESULTS: Of 8179 respondents passing quality filters, 6409 (78.40%) were white and 985 (12.05%) were black. Self-reported glaucoma prevalence was 7.85% and 16.34% in white and black respondents, respectively. White respondents had a mean age of 76.97 (SD 7.53) and were 57.25% female. Black respondents had a similar mean age of 74.96 (SD 7.27) and were 62.54% female. More than 87% of both groups were assessed in 2012. Preliminary GWAS analyses did not replicate known glaucoma loci and no variants attained genome-wide significance. A suggestive variant (p
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- 2019
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6. Glaucoma Genetic Risk Scores in the Million Veteran Program
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Andrea R. Waksmunski, Tyler G. Kinzy, Lauren A. Cruz, Cari L. Nealon, Christopher W. Halladay, Piana Simpson, Rachael L. Canania, Scott A. Anthony, David P. Roncone, Lea Sawicki Rogers, Jenna N. Leber, Jacquelyn M. Dougherty, Paul B. Greenberg, Jack M. Sullivan, Wen-Chih Wu, Sudha K. Iyengar, Dana C. Crawford, Neal S. Peachey, Jessica N. Cooke Bailey, J. Michael Gaziano, Rachel Ramoni, Jim Breeling, Kyong-Mi Chang, Grant Huang, Sumitra Muralidhar, Christopher J. O’Donnell, Philip S. Tsao, Jennifer Moser, Stacey B. Whitbourne, Jessica V. Brewer, John Concato, Stuart Warren, Dean P. Argyres, Brady Stephens, Mary T. Brophy, Donald E. Humphries, Nhan Do, Shahpoor Shayan, Xuan-Mai T. Nguyen, Saiju Pyarajan, Kelly Cho, Elizabeth Hauser, Yan Sun, Hongyu Zhao, Peter Wilson, Rachel McArdle, Louis Dellitalia, John Harley, Jeffrey Whittle, Jean Beckham, John Wells, Salvador Gutierrez, Gretchen Gibson, Laurence Kaminsky, Gerardo Villareal, Scott Kinlay, Junzhe Xu, Mark Hamner, Kathlyn Sue Haddock, Sujata Bhushan, Pran Iruvanti, Michael Godschalk, Zuhair Ballas, Malcolm Buford, Stephen Mastorides, Jon Klein, Nora Ratcliffe, Hermes Florez, Alan Swann, Maureen Murdoch, Peruvemba Sriram, Shing Shing Yeh, Ronald Washburn, Darshana Jhala, Samuel Aguayo, David Cohen, Satish Sharma, John Callaghan, Kris Ann Oursler, Mary Whooley, Sunil Ahuja, Amparo Gutierrez, Ronald Schifman, Jennifer Greco, Michael Rauchman, Richard Servatius, Mary Oehlert, Agnes Wallbom, Ronald Fernando, Timothy Morgan, Todd Stapley, Scott Sherman, Gwenevere Anderson, Philip Tsao, Elif Sonel, Edward Boyko, Laurence Meyer, Samir Gupta, Joseph Fayad, Adriana Hung, Jack Lichy, Robin Hurley, Brooks Robey, and Robert Striker
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Ophthalmology ,Cross-Sectional Studies ,Risk Factors ,Case-Control Studies ,Humans ,Genetic Predisposition to Disease ,Polymorphism, Single Nucleotide ,Glaucoma, Open-Angle ,Genome-Wide Association Study ,Veterans - Abstract
Primary open-angle glaucoma (POAG) is a degenerative eye disease for which early treatment is critical to mitigate visual impairment and irreversible blindness. POAG-associated loci individually confer incremental risk. Genetic risk score(s) (GRS) could enable POAG risk stratification. Despite significantly higher POAG burden among individuals of African ancestry (AFR), GRS are limited in this population. A recent large-scale, multi-ancestry meta-analysis identified 127 POAG-associated loci and calculated cross-ancestry and ancestry-specific effect estimates, including in European ancestry (EUR) and AFR individuals. We assessed the utility of the 127-variant GRS for POAG risk stratification in EUR and AFR Veterans in the Million Veteran Program (MVP). We also explored the association between GRS and documented invasive glaucoma surgery (IGS).Cross-sectional study.MVP Veterans with imputed genetic data, including 5830 POAG cases (445 with IGS documented in the electronic health record) and 64 476 controls.We tested unweighted and weighted GRS of 127 published risk variants in EUR (3382 cases and 58 811 controls) and AFR (2448 cases and 5665 controls) Veterans in the MVP. Weighted GRS were calculated using effect estimates from the most recently published report of cross-ancestry and ancestry-specific meta-analyses. We also evaluated GRS in POAG cases with documented IGS.Performance of 127-variant GRS in EUR and AFR Veterans for POAG risk stratification and association with documented IGS.GRS were significantly associated with POAG (Plt; 5 × 10sup-5/sup) in both groups; a higher proportion of EUR compared with AFR were consistently categorized in the top GRS decile (21.9%-23.6% and 12.9%-14.5%, respectively). Only GRS weighted by ancestry-specific effect estimates were associated with IGS documentation in AFR cases; all GRS types were associated with IGS in EUR cases.Varied performance of the GRS for POAG risk stratification and documented IGS association in EUR and AFR Veterans highlights (1) the complex risk architecture of POAG, (2) the importance of diverse representation in genomics studies that inform GRS construction and evaluation, and (3) the necessity of expanding diverse POAG-related genomic data so that GRS can equitably aid in screening individuals at high risk of POAG and who may require more aggressive treatment.
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- 2022
7. Mitochondrial TXNRD2 and ME3 Genetic Risk Scores Are Associated with Specific Primary Open-Angle Glaucoma Phenotypes
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Inas F. Aboobakar, Tyler G. Kinzy, Yan Zhao, Baojian Fan, Louis R. Pasquale, Ayub Qassim, Antonia Kolovos, Joshua M. Schmidt, Jamie E. Craig, Jessica N. Cooke Bailey, Janey L. Wiggs, R. Rand Allingham, Murray Brilliant, Donald L. Budenz, John H. Fingert, Douglas Gaasterland, Teresa Gaasterland, Jonathan L. Haines, Michael A. Hauser, Richard K. Lee, Paul R. Lichter, Yutao Liu, Syoko Moroi, Jonathan Myers, Margaret Pericak-Vance, Anthony Realini, Doug Rhee, Julia E. Richards, Robert Ritch, Joel S. Schuman, William K. Scott, Kuldev Singh, Arthur J. Sit, Douglas Vollrath, Robert N. Weinreb, Gadi Wollstein, and Donald J. Zack
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Ophthalmology - Published
- 2023
8. Development and Evaluation of a Rules-based Algorithm for Primary Open-Angle Glaucoma in the VA Million Veteran Program
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Lea R. Sawicki Rogers, Jack M. Sullivan, Tyler G. Kinzy, David P. Roncone, Christopher W. Halladay, Jenna N. Leber, Cari L. Nealon, Scott A. Anthony, Jacquelyn M. Dougherty, Rachael Canania, Neal S. Peachey, Dana C. Crawford, Piana Simpson, Sudha K. Iyengar, Paul B. Greenberg, Jessica N. Cooke Bailey, and Wen-Chih Wu
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genetic structures ,Open angle glaucoma ,Epidemiology ,business.industry ,Reproducibility of Results ,Glaucoma ,Gold standard (test) ,medicine.disease ,Biobank ,eye diseases ,Ophthalmology ,Positive predicative value ,Clinical diagnosis ,Humans ,Electronic Health Records ,Medicine ,Medical prescription ,business ,Algorithm ,Veterans Affairs ,Glaucoma, Open-Angle ,Algorithms ,Veterans - Abstract
The availability of electronic health record (EHR)-linked biobank data for research presents opportunities to better understand complex ocular diseases. Developing accurate computable phenotypes for ocular diseases for which gold standard diagnosis includes imaging remains inaccessible in most biobank-linked EHRs. The objective of this study was to develop and validate a computable phenotype to identify primary open-angle glaucoma (POAG) through accessing the Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) and Million Veteran Program (MVP) biobank. Accessing CPRS clinical ophthalmology data from VA Medical Center Eye Clinic (VAMCEC) patients, we developed and iteratively refined POAG case and control algorithms based on clinical, prescription, and structured diagnosis data (ICD-CM codes). Refinement was performed via detailed chart review, initially at a single VAMCEC (n = 200) and validated at two additional VAMCECs (n = 100 each). Positive and negative predictive values (PPV, NPV) were computed as the proportion of CPRS patients correctly classified with POAG or without POAG, respectively, by the algorithms, validated by ophthalmologists and optometrists with access to gold-standard clinical diagnosis data. The final algorithms performed better than previously reported approaches in assuring the accuracy and reproducibility of POAG classification (PPV >83% and NPV >97%) with consistent performance in Black or African American and in White Veterans. Applied to the MVP to identify cases and controls, genetic analysis of a known POAG-associated locus further validated the algorithms. We conclude that ours is a viable approach to use combined EHR-genetic data to study patients with complex diseases that require imaging confirmation.
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- 2021
9. Diversity is key for cross-ancestry transferability of glaucoma genetic risk scores in Hispanic Veterans in the Million Veteran Program
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Andrea R, Waksmunski, Tyler G, Kinzy, Lauren A, Cruz, Cari L, Nealon, Christopher W, Halladay, Scott A, Anthony, Paul B, Greenberg, Jack M, Sullivan, Wen-Chih, Wu, Sudha K, Iyengar, Dana C, Crawford, Neal S, Peachey, and Jessica N, Cooke Bailey
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Risk Factors ,Humans ,Computational Biology ,Genetic Predisposition to Disease ,Hispanic or Latino ,Polymorphism, Single Nucleotide ,Glaucoma, Open-Angle ,Genome-Wide Association Study ,Veterans - Abstract
A major goal of precision medicine is to stratify patients based on their genetic risk for a disease to inform future screening and intervention strategies. For conditions like primary open-angle glaucoma (POAG), the genetic risk architecture is complicated with multiple variants contributing small effects on risk. Following the tepid success of genome-wide association studies for high-effect disease risk variant discovery, genetic risk scores (GRS), which collate effects from multiple genetic variants into a single measure, have shown promise for disease risk stratification. We assessed the application of GRS for POAG risk stratification in Hispanic-descent (HIS) and European-descent (EUR) Veterans in the Million Veteran Program. Unweighted and cross-ancestry meta-weighted GRS were calculated based on 127 genomic variants identified in the most recent report of cross-ancestry POAG meta-analyses. We found that both GRS types were associated with POAG case-control status and performed similarly in HIS and EUR Veterans. This trend was also seen in our subset analysis of HIS Veterans with less than 50% EUR global genetic ancestry. Our findings highlight the importance of evaluating GRS based on known POAG risk variants in different ancestry groups and emphasize the need for more multi-ancestry POAG genetic studies.
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- 2022
10. Note the Nuance-Examining the Association of Alzheimer-Protective APOE Variation With Risk for Age-Related Macular Degeneration
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Michelle Grunin, Tyler G. Kinzy, and Jessica N. Cooke Bailey
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Ophthalmology - Published
- 2022
11. Diversity is key for cross-ancestry transferability of glaucoma genetic risk scores in Hispanic Veterans in the Million Veteran Program
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Andrea R. Waksmunski, Tyler G. Kinzy, Lauren A. Cruz, Cari L. Nealon, Christopher W. Halladay, Scott A. Anthony, Paul B. Greenberg, Jack M. Sullivan, Wen-Chih Wu, Sudha K. Iyengar, Dana C. Crawford, Neal S. Peachey, and Jessica N. Cooke Bailey
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- 2022
12. Evaluation of Restrictions on Tobacco Sales to Youth Younger Than 21 Years in Cleveland, Ohio, Area
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Erika Trapl, Stephanie Pike Moore, Catherine Osborn, Neha Gupta, Thomas E. Love, Tyler G. Kinzy, Audrey Kinsella, and Scott Frank
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Male ,Tobacco Use ,Adolescent ,Tobacco ,Humans ,Female ,General Medicine ,Tobacco Products ,Electronic Nicotine Delivery Systems ,Ohio - Abstract
Tobacco 21 (T21) policies raise the minimum legal age to purchase tobacco from 18 to 21 years to curb youth access to tobacco products. While some studies have found that T21 is associated with reducing prevalence of youth tobacco use, little is known about the impact it may have on youth of different racial and ethnic identities.To evaluate the association of T21 policy with the prevalence of high school youth tobacco use across sex, race, and ethnicity.This survey study used representative survey data collected from the local biennial Youth Risk Behavior Survey from 2013 to 2017 comparing Cleveland, Ohio (which has a T21 policy), to proximal jurisdictions in the first-ring suburbs in Cuyahoga County (which do not have T21 policies). Within-Cleveland demographic information was also collected for 2013 to 2019. Overall high school youth tobacco use rates were compared between Cleveland and the first-ring suburbs and then examined within Cleveland among Hispanic, non-Hispanic Black, and non-Hispanic White high school students. Percentage data were adjusted to more closely align with local population demographics. Data were analyzed from January to June 2022.T21 was implemented in Cleveland in 2016 and not adopted in proximal jurisdictions or at the state and federal level until at least 1 year later.The main outcomes were prevalence of past 30-day cigarette, cigar product, or e-cigarette use, measured using geographically representative high school youth survey data from 2013 to 2015 (prelegislation) and 2017 to 2019 (postlegislation) and compared using a difference-in-differences analysis.The unweighted sample included 12 616 high school students (27.0% [95% CI, 26.9%-28.0%] in 10th grade; 50.9% [95% CI, 50.3%-51.6%] females) participating in 1 or more Youth Risk Behavior Surveys from 2013 to 2019, including 7064 students in Cleveland and 5552 students in the first-ring suburbs. Compared with the first-ring suburbs, Cleveland had a greater proportion of younger students (1623 [28.5%] ninth grade students vs 2179 [34.0%] ninth grade students) and Hispanic students (436 students [1.1%] vs 1433 students [12.6%]) and non-Hispanic Black students (2000 students [53.1%] vs 3971 students [75.1%]). Cigars were the most commonly used tobacco product in Cleveland, with use reported by 6201 students (19.8%) in 2013, 5877 students (21.3%) in 2015, and 5784 students (16.8%) in 2019. Compared with the first-ring suburbs, there was a greater decline in prevalence of use of cigars in Cleveland (β = 0.18 [SE, 0.05]; P .001). The disparity across race, ethnicity, and sex decreased for all current tobacco product use. For example, the maximum difference between demographic subpopulations in current cigarette use was 11.6 (95% CI, 9.5-13.7) percentage points in 2013 between White females (16.1% [95% CI, 11.3%-20.8%]) and Black males (4.5% [95% CI, 3.5%-5.4%]). This maximum difference in current cigarette use decreased significantly to 5.1 (95% CI, 3.5-6.7) percentage points in 2019 between White females (6.9% [95% CI, 3.4%-10.3%]) and Black females (1.8% [95% CI, 0.7%-2.8%]).This survey study found that there was a decline in youth-reported tobacco use across every tobacco product category from 2013 to 2019. This decline changed the trajectory of use among several demographic groups and brought the youth populations with the highest tobacco product use to similar rates of others.
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- 2022
13. Satisfaction with Care and Satisfaction with Decision Making are Similar Regardless of Staffing Model in a Neurocritical Care Unit
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Christopher R. Newey, Joao Gomes, Pravin George, Dhimant Dani, Ryan D. Honomichl, Gwen Lynch, Tarig Omer, Tyler G. Kinzy, David Hang, Michael Stoltz, Irene L. Katzan, Samer Abubakr, Sarah Conley, Anita Maraj, and Bradley Douglas
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medicine.medical_specialty ,Critical Illness ,Decision Making ,Staffing ,Personal Satisfaction ,Critical Care and Intensive Care Medicine ,Unit (housing) ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,Advanced practice providers ,Neurocritical care ,Medicine ,Humans ,Shared medical decision making ,Sibling ,Satisfaction with decision ,Resident ,business.industry ,Critically ill ,Neurointensive care ,030208 emergency & critical care medicine ,Intensive Care Units ,Spouse ,Family medicine ,Workforce ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Original Work - Abstract
Introduction Patient-centered care, particularly shared medical decision making, is difficult to measure in critically ill patients where decisions are often made by a designated surrogate, often receiving information from multiple providers with varying degrees of training. The purpose of this study was to compare short-term satisfaction with care and decision making in patients or surrogates between two neurocritical care units [one staffed by a neurocritical care attending and advanced practice providers (APPs) and one staffed by a neurocritical care attending and resident/fellow trainees] using the Family Satisfaction in the ICU (FS-ICU) survey. Methods Over a 6-month period, the FS-ICU was administered on a tablet device to patients or surrogates at least 24 h after admission and stored on REDCap database. Results One hundred and thirty-four patients or surrogates completed the FS-ICU. The response rates were 59.97% and 46.58% in the APP and trainee units, respectively. There were no differences in patient age, sex, ventilator days or ICU length of stay. Overall, there were no differences in satisfaction with care or perceived shared medical making between the units. Respondents who identified their relationship with the patient as “other” (not a spouse, parent, nor a sibling) were less satisfied with care. Additionally, surrogates who identified as parents of the patient were more satisfied with degree of shared medical decision making. Conclusion This study showed that: (1) collecting FS-ICU in a neurocritical care unit is feasible, (2) overall there is no difference in short-term satisfaction with care or shared decision making between a NICU staffed with trainees compared to one staffed with APPs, and (3) parents of patients have a higher short-term satisfaction with degree of shared medical decision making.
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- 2020
14. Diversity in Polygenic Risk of Primary Open-Angle Glaucoma
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Jessica N. Cooke Bailey, Kaitlyn L. Funk, Lauren A. Cruz, Andrea R. Waksmunski, Tyler G. Kinzy, Janey L. Wiggs, and Michael A. Hauser
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Genetics ,Genetics (clinical) - Abstract
Glaucoma is the leading cause of irreversible blindness worldwide. Primary open-angle glaucoma (POAG), the most common glaucoma subtype, is more prevalent and severe in individuals of African ancestry. Unfortunately, this ancestral group has been historically under-represented among genetic studies of POAG. Moreover, both genetic and polygenic risk scores (GRS, PRS) that are typically based on genetic data from European-descent populations are not transferable to individuals without a majority of European ancestry. Given the aspirations of leveraging genetic information for precision medicine, GRS and PRS demonstrate clinical potential but fall short, in part due to the lack of diversity in these studies. Prioritizing diversity in the discovery of risk variants will improve the performance and utility of GRS and PRS-derived risk estimation for disease stratification, which could bring about earlier POAG intervention and treatment for a disease that often goes undetected until significant damage has occurred.
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- 2022
15. Distribution of rare LOXL1 missense alleles, haplotypes and diplotypes suggests association with reduced risk of glaucoma-related exfoliation syndrome
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J. H. Kang, R. Ritch, Tyler G. Kinzy, Tin Aung, Richard K. Lee, Louis R. Pasquale, Robert P. Igo, Chiea Chuen Khor, J. N. Cooke Bailey, Haines Jl, Margaret A. Pericak-Vance, Janey L. Wiggs, and Arthur J. Sit
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Minor allele frequency ,Genetics ,Loss of heterozygosity ,Exact test ,Haplotype ,Genotype ,Missense mutation ,Allele ,Biology ,Exome ,eye diseases - Abstract
PurposeCommon LOXL1 protein-altering variants are significant genetic risk factors for exfoliation syndrome (XFS) and the related secondary glaucoma (XFG). A rare LOXL1 missense allele has been associated with protective effects in a Japanese cohort, suggesting that other rare alleles may also exhibit protective effects. The goal of this study was to assess the contributions of rare LOXL1 variants to XFS/XFG risk in cases and controls from the United States.MethodsLOXL1 rare (minor allele frequency less than 1%) variants were identified from Humanexome BeadArray (Illumina) data for 1118 XFS/XFG cases and 3661 controls. Distribution of rare variants, haplotypes (defined using IMPUTE2) and diplotypes were examined using the Fisher’s exact test. Rare variant allele distribution was confirmed in an independent set of primary open angle glaucoma (POAG) controls and multi-ethnic datasets. Correlation of LOXL1 common allele homozygosity with disease risk used data from gnomAD (gnomad.broadinstitute.org/) and an existing multi-ethnic meta-analysis.ResultsFour rare LOXL1 missense alleles were identified, and all were more common in controls (combined P= 7.6E-4), with two of these located in a LOXL1 intrinsic disordered region (IDR) known to be involved in LOXL1 aggregation. Haplotypes that included the rare or minor variants were more common in controls compared to cases (OR= 0.33, P=1.7E-8). Heterozygous diplotypes were significantly associated with reduced risk overall (OR= 0.45 P= 1.7 E-89) with the largest effects observed for diplotypes with more than one heterozygous genotype (OR= 0.05, P= 1.0E-39). A homozygous diplotype was associated with increased disease risk (OR= 6.8, P= 4.7E-157) and homozygosity was correlated with disease risk for common LOXL1 variants across multi-ethnic populations (Pearson= 0.92, PConclusionsUsing exome array data from XFS/XFG cases and controls from the United States, we identify 4 rare protective LOXL1 missense variants and show that the distribution of the corresponding haplotypes and diplotypes are associated with reduced risk of XFS/XFG. The diplotype results also demonstrate that LOXL1 allelic heterozygosity is protective while homozygosity is associated with increased disease risk. These results suggest that LOXL1 minor allele frequency variation among populations, with corresponding variation in genotype heterozgyosity and homozygosity, determines the XFS/XFG association effects and that genotypic effects may also impact protein aggregation involving intrinsic disordered regions.
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- 2021
16. Polygenic Risk Scores
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Tyler G. Kinzy, Jessica N. Cooke Bailey, and Michael D. Osterman
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Multifactorial Inheritance ,General Immunology and Microbiology ,General Neuroscience ,Health Informatics ,Sample (statistics) ,Disease ,General Biochemistry, Genetics and Molecular Biology ,Single measure ,Medical Laboratory Technology ,Risk Factors ,Disease risk ,Polygenic risk score ,General Pharmacology, Toxicology and Pharmaceutics ,Genetic risk ,Psychology ,Software ,Clinical psychology ,Genetic association ,Genome-Wide Association Study - Abstract
As genome-wide association studies have continued to identify loci associated with complex traits, the implications of and necessity for proper use of these findings, including prediction of disease risk, have become apparent. Many complex diseases have numerous associated loci with detectable effects implicating risk for or protection from disease. A common contemporary approach to using this information for disease prediction is through the application of genetic risk scores. These scores estimate an individual's liability for a specific outcome by aggregating the effects of associated loci into a single measure as described in the previous version of this article. Although genetic risk scores have traditionally included variants that meet criteria for genome-wide significance, an extension known as the polygenic risk score has been developed to include the effects of more variants across the entire genome. Here, we describe common methods and software packages for calculating and interpreting polygenic risk scores. In this revised version of the article, we detail information that is needed to perform a polygenic risk score analysis, considerations for planning the analysis and interpreting results, as well as discussion of the limitations based on the choices made. We also provide simulated sample data and a walkthrough for four different polygenic risk score software. © 2021 Wiley Periodicals LLC.
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- 2021
17. Sensitivity and specificity of patient-entered red flags for lower back pain
- Author
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Joseph E. Tanenbaum, John T. Tsiang, Tagreed Khalaf, Irene L. Katzan, Tyler G. Kinzy, Nitya L. Thakore, and Nicolas R. Thompson
- Subjects
Male ,medicine.medical_specialty ,endocrine system diseases ,Population ,Cauda equina syndrome ,Context (language use) ,Sensitivity and Specificity ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Back pain ,Humans ,Orthopedics and Sports Medicine ,Medical diagnosis ,education ,Retrospective Studies ,Neurologic Examination ,030222 orthopedics ,education.field_of_study ,business.industry ,Medical record ,Cauda equina ,medicine.disease ,Low back pain ,medicine.anatomical_structure ,Case-Control Studies ,Female ,Surgery ,Self Report ,Neurology (clinical) ,medicine.symptom ,business ,Low Back Pain ,030217 neurology & neurosurgery - Abstract
Background Context Red flags are questions typically ascertained by providers to screen for serious underlying spinal pathologies. The utility of patient-reported red flags in guiding clinical decision-making for spine care, however, has not been studied. Purpose The aim of this study was to quantify the sensitivity and specificity of patient-reported red flags in predicting the presence of serious spinal pathologies. Study Design This was a retrospective nested case-control study. Patient Sample This study consisted of 120 patients with International Classification of Diseases, Ninth Revision, Clinical Modification codes for spinal pathologies and 380 randomly selected patients, from a population of 4,313 patients seen at a large tertiary care spine clinic between October 9, 2013 and June 30, 2014. Outcome Measures The presence of patient-reported red flags and red flags obtained from medical records was verified for chart review. The spinal pathology (ie, malignancy, fractures, infections, or cauda equina syndrome) was noted for each patient. Methods The sensitivity and specificity of patient-reported red flags for detecting serious spinal pathologies were calculated from data obtained from the 500 patients. Youden's J was used to rank performance. Agreement between patient-reported red flags and those obtained from medical record review was assessed via Cohen's kappa statistic. Results “History of cancer” was the best performing patient-reported red flag to identify malignancy (sensitivity=0.75 [95% confidence intervals, CI 0.53–0.90], specificity=0.79 [95% CI 0.75–0.82]). The best performing patient-reported red flag for fractures was the presence of at least one of the following: “Osteoporosis,” “Steroid use,” and “Trauma” (sensitivity=0.59 [95% CI 0.44–0.72], specificity=0.65 [95% CI 0.60–0.69]). The prevalence of infection and cauda equina diagnoses was insufficient to gauge sensitivity and specificity. Red flags from medical records had better performance than patient-reported red flags. There was poor agreement between patient red flags and those obtained from medical record review. Conclusions Patient-reported red flags had low sensitivity and specificity for identification of serious pathologies. They should not be used in insolation to make treatment decisions, although they may be useful to prompt further probing to determine if additional investigation is warranted.
- Published
- 2019
18. The role of genetic polymorphisms in executive functioning performance in temporal lobe epilepsy
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Christine Doherty, Imad Najm, Charis Eng, Robyn M. Busch, Bruce P. Hermann, Lisa Ferguson, Tyler G. Kinzy, and Jessica Altemus
- Subjects
Adult ,medicine.medical_specialty ,Trail Making Test ,Audiology ,Neuropsychological Tests ,behavioral disciplines and activities ,Article ,Temporal lobe ,03 medical and health sciences ,Behavioral Neuroscience ,Epilepsy ,Executive Function ,0302 clinical medicine ,Wisconsin Card Sorting Test ,medicine ,Verbal fluency test ,Humans ,Epilepsy surgery ,030212 general & internal medicine ,Polymorphism, Genetic ,business.industry ,Neuropsychology ,medicine.disease ,nervous system ,Neurology ,Epilepsy, Temporal Lobe ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Delis–Kaplan Executive Function System - Abstract
Objective To explore the role of several genetic polymorphisms (APOE e4, BDNF Met, and COMT Val) in executive functioning performance in patients with pharmacoresistant temporal lobe epilepsy (TLE). Methods Ninety-three adults (51 female, mean age = 39 years) with TLE completed executive functioning measures as part of a comprehensive preoperative neuropsychological evaluation, including Trail Making Test (Part B), Wisconsin Card Sorting Test (Conceptual Level Responses and Perseverative Errors), Color Word Interference from the Delis Kaplan Executive Function System, and measures of phonemic and semantic verbal fluency. Genotyping of the APOE, BDNF, and COMT genes was conducted using DNA extracted from peripheral blood or brain tissue (from epilepsy surgery). Results After adjustment for general cognitive ability, COMT Val carriers showed poorer performance on semantic verbal fluency and color word interference than non-carriers, and BDNF Met carriers showed poorer performance on phonemic verbal fluency than those without a Met allele. Significance Results suggest that COMT and BDNF polymorphisms are associated with performance on several EF measures in patients with TLE, including tasks assessing verbal fluency and response inhibition and account for up to 16% of the variance in test performance. The APOE polymorphism was not significantly associated with any of the executive function measures analyzed.
- Published
- 2021
19. The GGLEAM Study: Understanding Glaucoma in the Ohio Amish
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Andrea R. Waksmunski, Sherri D. Miller, Jonathan M. Skarie, Jessica N. Cooke Bailey, Sarada Fuzzell, Tyler G. Kinzy, Jonathan L. Haines, Louis R. Pasquale, Yeunjoo E. Song, Renee Laux, Jane L. Sewell, Denise Fuzzell, and Janey L. Wiggs
- Subjects
Gerontology ,vision ,genetic structures ,Health, Toxicology and Mutagenesis ,Population ,Visual impairment ,Glaucoma ,lcsh:Medicine ,Article ,03 medical and health sciences ,0302 clinical medicine ,Kinship ,medicine ,Humans ,Family history ,education ,Ohio ,030304 developmental biology ,0303 health sciences ,education.field_of_study ,family history ,business.industry ,lcsh:R ,Public Health, Environmental and Occupational Health ,medicine.disease ,Genetic architecture ,eye diseases ,Pedigree ,endophenotype ,glaucoma ,Protestantism ,Endophenotype ,030221 ophthalmology & optometry ,sense organs ,founder population ,medicine.symptom ,business ,Amish ,Founder effect - Abstract
Glaucoma leads to millions of cases of visual impairment and blindness around the world. Its susceptibility is shaped by both environmental and genetic risk factors. Although over 120 risk loci have been identified for glaucoma, a large portion of its heritability is still unexplained. Here we describe the foundation of the Genetics of GLaucoma Evaluation in the AMish (GGLEAM) study to investigate the genetic architecture of glaucoma in the Ohio Amish, which exhibits lower genetic and environmental heterogeneity compared to the general population. To date, we have enrolled 81 Amish individuals in our study from Holmes County, Ohio. As a part of our enrollment process, 62 GGLEAM study participants (42 glaucoma-affected and 20 unaffected individuals) received comprehensive eye examinations and glaucoma evaluations. Using the data from the Anabaptist Genealogy Database, we found that 80 of the GGLEAM study participants were related to one another through a large, multigenerational pedigree containing 1586 people. We plan to integrate the health and kinship data obtained for the GGLEAM study to interrogate glaucoma genetics and pathophysiology in this unique population.
- Published
- 2021
20. Physical Activity Monitoring Using a Fitbit Device in Ischemic Stroke Patients: Prospective Cohort Feasibility Study
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Andrew Schuster, Tyler G. Kinzy, and Irene L. Katzan
- Subjects
Adult ,Male ,medicine.medical_specialty ,Intraclass correlation ,Physical activity ,physical activity ,Aftercare ,Monitoring, Ambulatory ,Health Informatics ,Information technology ,step activity monitor ,03 medical and health sciences ,0302 clinical medicine ,Modified Rankin Scale ,medicine ,ischemic stroke ,Humans ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,Stroke ,Exercise ,Balance (ability) ,Aged ,Aged, 80 and over ,Original Paper ,business.industry ,Middle Aged ,medicine.disease ,T58.5-58.64 ,Actigraphy ,Patient Discharge ,Treatment Adherence and Compliance ,accelerometer ,Ambulatory ,Ischemic stroke ,Physical therapy ,Feasibility Studies ,Patient Compliance ,Female ,Public aspects of medicine ,RA1-1270 ,business ,030217 neurology & neurosurgery - Abstract
Background Continuous tracking of ambulatory activity in real-world settings using step activity monitors has many potential uses. However, feasibility, accuracy, and correlation with performance measures in stroke patients have not been well-established. Objective The primary study objective was to determine adherence with wearing a consumer-grade step activity monitor, the Fitbit Charge HR, in home-going ischemic stroke patients during the first 90 days after hospital discharge. Secondary objectives were to (1) determine accuracy of step counts of the Fitbit Charge HR compared with a manual tally; (2) calculate correlations between the Fitbit step counts and the mobility performance scores at discharge and 30 days after stroke; (3) determine variability and change in weekly step counts over 90 days; and (4) evaluate patient experience with using the Fitbit Charge HR poststroke. Methods A total of 15 participants with recent mild ischemic stroke wore a Fitbit Charge HR for 90 days after discharge and completed 3 mobility performance tests from the National Institutes of Health Toolbox at discharge and Day 30: (1) Standing Balance Test, (2) 2-Minute Walk Endurance Test, and (3) 4-Meter Walk Gait Speed Test. Accuracy of step activity monitors was assessed by calculating differences in steps recorded on the step activity monitor and a manual tally during 2-minute walk tests. Results Participants had a mean age of 54 years and a median modified Rankin scale score of 1. Mean daily adherence with step activity monitor use was 83.6%. Mean daily step count in the first week after discharge was 4376. Daily step counts increased slightly during the first 30 days after discharge (average increase of 52.5 steps/day; 95% CI 32.2-71.8) and remained stable during the 30-90 day period after discharge. Mean step count difference between step activity monitor and manual tally was –4.8 steps (–1.8%). Intraclass correlation coefficients for step counts and 2-minute walk, standing balance, and 4-meter gait speed at discharge were 0.41 (95% CI –0.14 to 0.75), –0.12 (95% CI –0.67 to 0.64), and 0.17 (95% CI –0.46 to 0.66), respectively. Values were similarly poor at 30 days. Conclusions The use of consumer-grade Fitbit Charge HR in patients with recent mild stroke is feasible with reasonable adherence and accuracy. There was poor correlation between step counts and gait speed, balance, and endurance. Further research is needed to evaluate the association between step counts and other outcomes relevant to patients, including patient-reported outcomes and measures of physical function.
- Published
- 2021
21. Multitrait analysis of glaucoma identifies new risk loci and enables polygenic prediction of disease susceptibility and progression
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Henry Marshall, Paul R. Healey, Stuart MacGregor, Paul Mitchell, Cornelia M. van Duijn, Tyler G. Kinzy, Nicholas H Andrew, Stephen Best, Angela J. Cree, Louis R. Pasquale, Xikun Han, Alex W. Hewitt, Andrea L Vincent, Robert J Casson, Christopher J Hammond, Jiyuan An, Paul J. Foster, Matthew Law, Tiger Zhou, Sobha Sivaprasad, Veronique Vitart, Mark M. Hassall, Peng T. Khaw, Francesca Pasutto, Andrew J. Lotery, Tin Aung, Robert P. Igo, Puya Gharahkhani, Kathryn P. Burdon, Nicholas G. Martin, Ashish Agar, Ivan Goldberg, Neeru A. Vallabh, Pirro G. Hysi, David A. Mackey, Jonathan B Ruddle, Colin E. Willoughby, John Landers, Jue-Sheng Ong, Ananth C. Viswanathan, Bronwyn Ridge, Anthony P Khawaja, Emmanuelle Souzeau, Grant W. Montgomery, Richard A. Mills, Jamie E Craig, Janey L. Wiggs, Jost B. Jonas, Caroline C W Klaver, Ayub Qassim, Graham L. Radford-Smith, Stuart L. Graham, Jonathan L. Haines, Andrew White, Anna Galanopoulos, Owen M. Siggs, Robert Wojciechowski, René Hoehn, Jessica N. Cooke Bailey, Ophthalmology, and Epidemiology
- Subjects
Multifactorial Inheritance ,medicine.medical_specialty ,Intraocular pressure ,Open angle glaucoma ,genetic structures ,medicine.medical_treatment ,Population ,Glaucoma ,Penetrance ,Trabeculectomy ,Biology ,Polymorphism, Single Nucleotide ,Article ,Sensory disorders Donders Center for Medical Neuroscience [Radboudumc 12] ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Genetic model ,Odds Ratio ,Genetics ,medicine ,Glaucoma surgery ,Humans ,Genetic Predisposition to Disease ,Eye Proteins ,education ,Intraocular Pressure ,Myocilin ,Glycoproteins ,030304 developmental biology ,0303 health sciences ,education.field_of_study ,Australia ,Optic Nerve ,medicine.disease ,United Kingdom ,United States ,eye diseases ,Cytoskeletal Proteins ,Case-Control Studies ,Disease Progression ,sense organs ,030217 neurology & neurosurgery ,Genome-Wide Association Study - Abstract
Contains fulltext : 218893.pdf (Publisher’s version ) (Closed access) Glaucoma, a disease characterized by progressive optic nerve degeneration, can be prevented through timely diagnosis and treatment. We characterize optic nerve photographs of 67,040 UK Biobank participants and use a multitrait genetic model to identify risk loci for glaucoma. A glaucoma polygenic risk score (PRS) enables effective risk stratification in unselected glaucoma cases and modifies penetrance of the MYOC variant encoding p.Gln368Ter, the most common glaucoma-associated myocilin variant. In the unselected glaucoma population, individuals in the top PRS decile reach an absolute risk for glaucoma 10 years earlier than the bottom decile and are at 15-fold increased risk of developing advanced glaucoma (top 10% versus remaining 90%, odds ratio = 4.20). The PRS predicts glaucoma progression in prospectively monitored, early manifest glaucoma cases (P = 0.004) and surgical intervention in advanced disease (P = 3.6 x 10(-)(6)). This glaucoma PRS will facilitate the development of a personalized approach for earlier treatment of high-risk individuals, with less intensive monitoring and treatment being possible for lower-risk groups.
- Published
- 2020
22. Accuracy of Linking VR-12 and PROMIS Global Health Scores in Clinical Practice
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Ajit A. Krishnaney, Tyler G. Kinzy, Nicolas R. Thompson, Brittany Lapin, and Irene L. Katzan
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Intraclass correlation ,Comparative effectiveness research ,Global Health ,Cohort Studies ,Correlation ,Young Adult ,03 medical and health sciences ,symbols.namesake ,0302 clinical medicine ,Global health ,Humans ,Medicine ,Patient Reported Outcome Measures ,030212 general & internal medicine ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,030503 health policy & services ,Health Policy ,Public Health, Environmental and Occupational Health ,Middle Aged ,Health Surveys ,Mental health ,Confidence interval ,Pearson product-moment correlation coefficient ,Sample size determination ,symbols ,Physical therapy ,Female ,Spinal Diseases ,0305 other medical science ,business - Abstract
Objectives To examine the accuracy of general health cross-walk tables in a clinical sample of patients with spine disorders. Published tables (Schalet BD, Rothrock NE, Hays RD, et al. Linking physical and mental health summary scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS(®) Global Health Scale. J Gen Intern Med 2015;30:1524–30) link scores from the Veterans RAND 12-Item Health Survey (VR-12) to the 10-Item Patient-Reported Outcome Measurement Information System (PROMIS), a global health scale metric for both mental (GMH) and physical (GPH) summary scores. Methods We assessed the accuracy of administered PROMIS and VR-12 scores with scores predicted by cross-walks in 4606 adult patients seen in a spine clinic from October 2015 to 2016. Accuracy of linking scores was evaluated using Pearson correlation, intraclass correlation coefficients, and mean and SD of score differences. Bland-Altman plots were used to graphically assess the levels of agreement. The consistency in scores’ discrimination across levels of pain severity, depression, and other patient characteristics was assessed. Bootstrap methods estimated linking precision across varying sample sizes. Results Actual and cross-walked PROMIS scores showed moderate correlation (ICC(3,1): GMH 0.73; GPH 0.81), with Bland-Altman plots suggesting smaller differences between scores in patients with lower and higher general health. Significant discrimination between patient subgroups was demonstrated reliably by both actual and estimated scores. Bootstrapped resamples indicated adequate precision for 200 patients (95% confidence interval for mean difference: GMH −1.38 to 0.60; GPH 0.39 to 1.93). Conclusions VR-12 and PROMIS global health scores can be accurately linked within a sample of patients with spine disorders; nevertheless, bias is high and precision is low for linking on the patient level. Linked scores at the group level for more than 200 patients can be used in comparative effectiveness research and for comparing results across studies.
- Published
- 2018
23. Frequency of ClinVar Pathogenic Variants in Chronic Kidney Disease Patients Surveyed for Return of Research Results at a Cleveland Public Hospital
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Tyler G. Kinzy, John F. O’Toole, John R. Sedor, Dana C. Crawford, William S. Bush, Jessica N. Cooke Bailey, and John Lin
- Subjects
0301 basic medicine ,education.field_of_study ,medicine.medical_specialty ,business.industry ,Population ,030105 genetics & heredity ,medicine.disease ,Penetrance ,3. Good health ,03 medical and health sciences ,030104 developmental biology ,Internal medicine ,Cohort ,Medicine ,Population study ,Clinical significance ,Allele ,Return of results ,education ,business ,Kidney disease - Abstract
Return of results is not common in research settings as standards are not yet in place for what to return, how to return, and to whom. As a pioneer of large-scale of return of research results, the Precision Medicine Initiative Cohort now known of All of Us plans to return pharmacogenomic results and variants of clinical significance to its participants starting late 2019. To better understand the local landscape of possibilities regarding return of research results, we assessed the frequency of pathogenic variants and APOL1 renal risk variants in a small diverse cohort of chronic kidney disease patients (CKD) ascertained from a public hospital in Cleveland, Ohio genotyped on the Illumina Infinium MegaEX. Of the 23,720 ClinVar-designated variants directly assayed by the MegaEX, 8,355 (35%) had at least one alternate allele in the 130 participants genotyped. Of these, 18 ClinVar variants deemed pathogenic by multiple submitters with no conflicts in interpretation were distributed across 27 participants. The majority of these pathogenic ClinVar variants (14/18) were associated with autosomal recessive disorders. Of note were four African American carriers of TTR rs76992529 associated with amyloidogenic transthyretin amyloidosis, otherwise known as familial transthyretin amyloidosis (FTA). FTA, an autosomal dominant disorder with variable penetrance, is more common among African-descent populations compared with European-descent populations. Also common in this CKD population were APOL1 renal risk alleles G1 (rs73885319) and G2 (rs71785313) with 60% of the study population carrying at least one renal risk allele. Both pathogenic ClinVar variants and APOL1 renal risk alleles were distributed among participants who wanted actionable genetic results returned, wanted genetic results returned regardless of actionability, and wanted no results returned. Results from this local genetic study highlight challenges in which variants to report, how to interpret them, and the participant's potential for follow-up, only some of the challenges in return of research results likely facing larger studies such as All of Us.
- Published
- 2019
24. Genetic Risk Scores
- Author
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Robert P. Igo, Tyler G. Kinzy, and Jessica N. Cooke Bailey
- Subjects
Genetic Markers ,Multifactorial Inheritance ,Phenotype ,Genotype ,Risk Factors ,Genetics ,Humans ,Disease ,Genetic Predisposition to Disease ,Genetics (clinical) ,Software ,Article - Abstract
Genome-wide variation data with millions of genetic markers have become commonplace. However, the potential for interpretation and application of these data for clinical assessment of outcomes of interest, and prediction of disease risk, is currently not fully realized. Many common complex diseases now have numerous, well-established risk loci and likely harbor many genetic determinants with effects too small to be detected at genome-wide levels of statistical significance. A simple and intuitive approach for converting genetic data to a predictive measure of disease susceptibility is to aggregate the effects of these loci into a single measure, the genetic risk score. Here, we describe some common methods and software packages for calculating genetic risk scores and polygenic risk scores, with focus on studies of common complex diseases. We review the basic information needed, as well as important considerations for constructing genetic risk scores, including specific requirements for phenotypic and genetic data, and limitations in their application. © 2019 by John WileySons, Inc.
- Published
- 2019
25. Deconstructing progression of amyotrophic lateral sclerosis in stages: a Markov modeling approach
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Erik P. Pioro, Brittany Lapin, Nimish J. Thakore, and Tyler G. Kinzy
- Subjects
Male ,Oncology ,Research design ,Prognostic variable ,medicine.medical_specialty ,Disease ,Markov model ,Severity of Illness Index ,01 natural sciences ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,Rating scale ,Internal medicine ,medicine ,Humans ,0101 mathematics ,Stage (cooking) ,Amyotrophic lateral sclerosis ,business.industry ,Amyotrophic Lateral Sclerosis ,Clinical Studies as Topic ,medicine.disease ,Survival Analysis ,Markov Chains ,Clinical trial ,Neurology ,Disease Progression ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
OBJECTIVES Propose an empirical amyotrophic lateral sclerosis (ALS) staging approach called Fine'til 9 (FT9) based on how many of the patient's ALS functional rating scale (ALSFRS-R) subscores are 9 or less (of normal 12). Gain insights into progression of ALS by applying Markov models to ALS stages by multiple systems (King's, Milan-Torino system (MITOS) and FT9). METHODS Patients from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) dataset were staged using ALSFRS-R responses. Risks of progression through stages and death were estimated, as were effects of prognostic variables on these risks. RESULTS A total of 29,947 time points in 3199 patients from the PRO-ACT dataset were assigned stages. Although the three systems were moderately correlated, MITOS stages were heavily skewed toward advanced disease, whereas King's and FT9 stages were more balanced. Non-sequential progression was observed with King's system. Markov models adequately described transitions from stage to stage in the first year of observation, but underestimated risks beyond that point. Regardless of staging method, initial rate of ALSFRS-R decline had a powerful effect on rate of progression through sequential stages, whereas age predominantly influenced stage-specific mortality. CONCLUSION King's and FT9 are more sensitive to observed progression of disease in clinical trials than MITOS. FT9 can partition the course similar to King's, and may have advantages of sequential progression and easy applicability to retrospective data. Markov transition intensity estimates may be of value for counseling, health economic studies, and research design. In particular, this framework permits estimation of multidimensional effects of variables (including treatment) on outcome.
- Published
- 2018
26. Factors Associated with Sexual Dysfunction in Individuals with Multiple Sclerosis
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Samantha Domingo, Tyler G. Kinzy, Shauna Gales, Nicolas R. Thompson, Amy Burleson Sullivan, and Lael Stone
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Advanced and Specialized Nursing ,business.industry ,Multiple sclerosis ,Human sexuality ,medicine.disease ,Affect (psychology) ,03 medical and health sciences ,0302 clinical medicine ,Quality of life (healthcare) ,Mood ,Sexual dysfunction ,Intervention (counseling) ,medicine ,030212 general & internal medicine ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Depression (differential diagnoses) ,Clinical psychology - Abstract
CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by the Consortium of Multiple Sclerosis Centers (CMSC) and Delaware Media Group. CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physician Credit The CMSC designates this journal-based activity for a maximum of 0.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Credit The CMSC designates this enduring material for 0.75 contact hours (none in the area of pharmacology). Disclosures: Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has received royalties from Springer Publishing and consulting fees from Ipsen and has performed contracted research for Biogen, Adamas Pharmaceuticals, Acorda Therapeutics, and Atlas5D.Francois Bethoux, MD, has served as reviewer for this activity. She has disclosed no relevant financial relationships.Laurie Scudder, DNP, NP, has disclosed no relevant financial relationships.Samantha Domingo, PsyD, has disclosed no relevant financial relationships.Tyler Kinzy, MS, has disclosed salary support to his institution from Novartis Pharmaceuticals for research outside of this study.Nicolas Thompson, MS, has disclosed no relevant financial relationships.Shauna Gales, PA-C, has disclosed no relevant financial relationships.Lael Stone, MD, has received a consulting fee from and served on a speakers' bureau for Novartis.Amy Sullivan, PsyD, ABPP, One peer reviewer for the IJMSC has received royalties from UpToDate Inc and served on speakers' bureaus for Allergan Inc and Astellas Inc. The other peer reviewer has disclosed no relevant financial relationships. The staff at the IJMSC, CMSC, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Disclosures listed for authors are those applicable at the time of their work on this project and within the previous 12 months. Method of Participation: Release Date: August 1, 2018 Valid for Credit Through: August 1, 2019 In order to receive CME/CNE credit, participants must: Statements of Credit are awarded upon successful completion of the post-test with a passing score of >70% and the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. CMSC and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of CMSC or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health-care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.
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- 2018
27. Continuous Electroencephalography in the Critically Ill
- Author
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Vineet Punia, Christopher R. Newey, Stephen Hantus, and Tyler G. Kinzy
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Male ,Pediatrics ,medicine.medical_specialty ,Critical Care ,Physiology ,Critical Illness ,Video Recording ,Electroencephalography ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Seizures ,Physiology (medical) ,medicine ,Humans ,Neurophysiological Monitoring ,Retrospective Studies ,Coma ,medicine.diagnostic_test ,business.industry ,Incidence ,Multiple sclerosis ,Incidence (epidemiology) ,Brain ,030208 emergency & critical care medicine ,Retrospective cohort study ,Odds ratio ,Middle Aged ,medicine.disease ,Confidence interval ,Neurology ,Female ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Purpose Electrographic seizures detected by continuous electroencephalography (CEEG) in critically ill patients with altered mental status is becoming increasingly recognized. Data guiding the appropriate selection of patients to be monitored on CEEG are lacking. The aims of this article were to study the incidence of seizures in the critical care setting and to evaluate for clinical predictors to improve the efficiency of CEEG monitoring. Methods Retrospective review of the CEEG and clinical data on 1,123 consecutive patients who had continuous video EEG over a 24-month period. Results Seizures were recorded in 215 patients on CEEG monitoring (19.1%). In total, 89.3% of these seizures occurred without clinical signs. Patients who were in a coma were more likely to have EEG seizures (odds ratio, 3.64; 95% confidence interval, 2.23-5.95) compared with those awake. The incidence of seizures was overrepresented in patients with extra-axial tumors (41.9%), multiple sclerosis (35.7%), and intra-axial tumors (33.0%). Lateralized periodic discharges were predictive (odds ratio, 8.27; 95% confidence interval, 5.52-12.46) of seizure occurrence compared with those with no epileptiform patterns. Only generalized periodic discharges with triphasic morphology had no increased odds of seizure (odds ratio, 1.02; 95% confidence interval, 0.24-3.03). When present, electroencephalography seizures were detected within 24 hours in 92% of monitored patients. Conclusions Continuous electroencephalography monitoring in the critical care setting demonstrates a linear increase in seizure incidence with declining mental status. Recognizing clinical conditions and electroencephalography markings may help in the appropriate selection of critically ill patients for CEEG monitoring.
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- 2018
28. Improved Outcomes With Integrated Intensivist Consultation for Cardiac Surgery Patients
- Author
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Roman Melamed, Robert S. Farivar, Maximilian Mulder, Susan C. Seatter, Lori L. Boland, Lisa L. Kirkland, Tyler G. Kinzy, and Omer W. Sultan
- Subjects
Male ,medicine.medical_specialty ,Critical Care ,business.industry ,Minnesota ,Health Policy ,Thoracic Surgery ,Intensivist ,Retrospective cohort study ,Middle Aged ,030204 cardiovascular system & hematology ,Cardiac surgery ,03 medical and health sciences ,0302 clinical medicine ,Emergency medicine ,Medical Staff, Hospital ,Humans ,Medicine ,Female ,Registries ,030212 general & internal medicine ,business ,Referral and Consultation ,Aged ,Retrospective Studies - Abstract
This study examined the impact of integrated intensivist consultation in the immediate postoperative period on outcomes for cardiac surgery patients. A retrospective cohort study was conducted in 1711 adult cardiac surgery patients from a single quaternary care center in Minnesota. Outcomes were compared across 2 consecutive 2-year time periods reflecting an elective intensivist model (n = 801) and an integrated intensivist model (n = 910). Patients under the 2 models were comparable with respect to demographics, comorbidities, procedure types, and Society for Thoracic Surgery predicted risk of mortality score; however, patients in the earlier cohort were slightly older and more likely to have chronic kidney disease ( P = .003). Integrated intensivist involvement was associated with reduced postoperative ventilator time, length of stay (LOS), stroke, encephalopathy, and reoperations for bleeding (all P < .01) but was not associated with mortality. Intensivist integration into the postoperative care of cardiac surgery patients may reduce ventilator time, LOS, and complications but may not improve survival.
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- 2018
29. Meta-analytic framework for modeling genetic coexpression dynamics
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Yen-Yi Ho, Tyler G. Kinzy, George C. Tseng, and Timothy K. Starr
- Subjects
Statistics and Probability ,Computer science ,Bayesian probability ,Network Meta-Analysis ,Computational biology ,01 natural sciences ,010104 statistics & probability ,03 medical and health sciences ,symbols.namesake ,Gene expression ,Genetics ,Statistical inference ,Microarray databases ,Bayesian hierarchical modeling ,Gene Regulatory Networks ,0101 mathematics ,Molecular Biology ,Gene ,030304 developmental biology ,Oligonucleotide Array Sequence Analysis ,0303 health sciences ,Gene Expression Profiling ,Markov chain Monte Carlo ,Bayes Theorem ,Epistasis, Genetic ,Data set ,Computational Mathematics ,symbols ,Algorithms - Abstract
Methods for exploring genetic interactions have been developed in an attempt to move beyond single gene analyses. Because biological molecules frequently participate in different processes under various cellular conditions, investigating the changes in gene coexpression patterns under various biological conditions could reveal important regulatory mechanisms. One of the methods for capturing gene coexpression dynamics, named liquid association (LA), quantifies the relationship where the coexpression between two genes is modulated by a third “coordinator” gene. This LA measure offers a natural framework for studying gene coexpression changes and has been applied increasingly to study regulatory networks among genes. With a wealth of publicly available gene expression data, there is a need to develop a meta-analytic framework for LA analysis. In this paper, we incorporated mixed effects when modeling correlation to account for between-studies heterogeneity. For statistical inference about LA, we developed a Markov chain Monte Carlo (MCMC) estimation procedure through a Bayesian hierarchical framework. We evaluated the proposed methods in a set of simulations and illustrated their use in two collections of experimental data sets. The first data set combined 10 pancreatic ductal adenocarcinoma gene expression studies to determine the role of possible coordinator gene USP9X in the Hippo pathway. The second experimental data set consisted of 907 gene expression microarray Escherichia coli experiments from multiple studies publicly available through the Many Microbe Microarray Database website (http://m3d.bu.edu/) and examined genes that coexpress with serA in the presence of coordinator gene Lrp.
- Published
- 2019
30. Prehospital Lactate Measurement by Emergency Medical Services in Patients Meeting Sepsis Criteria
- Author
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Jonathan S. Hokanson, Lori L. Boland, Tyler G. Kinzy, Charles Lick, Brian LaCroix, Paul A. Satterlee, and Karl M. Fernstrom
- Subjects
Male ,Emergency Medical Services ,medicine.medical_specialty ,lcsh:Medicine ,Pilot Projects ,law.invention ,Sepsis ,lactate measurement ,law ,Emergency medical services ,Humans ,Medicine ,In patient ,Prospective Studies ,Prospective cohort study ,Aged ,Original Research ,Point of care ,sepsis criteria ,business.industry ,lcsh:R ,lcsh:Medical emergencies. Critical care. Intensive care. First aid ,General Medicine ,Emergency department ,lcsh:RC86-88.9 ,medicine.disease ,Intensive care unit ,Systemic inflammatory response syndrome ,Emergency Medical Technicians ,Emergency medicine ,Lactates ,Emergency Medicine ,Prehospital Care ,Female ,Emergency Service, Hospital ,business - Abstract
Author(s): Boland, MPH, Lori L.; Hokanson, MD, Jonathan S.; Fernstrom, MPH, Karl M.; Kinzy, MS, Tyler G.; Lick, MD, Charles J.; Satterlee, MD, Paul A.; LaCroix, EMT-P, Brian K. | Abstract: Introduction: We aimed to pilot test the delivery of sepsis education to emergency medical services (EMS) providers and the feasibility of equipping them with temporal artery thermometers (TATs) and handheld lactate meters to aid in the prehospital recognition of sepsis. Methods: This study used a convenience sample of prehospital patients meeting established criteria for sepsis. Paramedics received education on systemic inflammatory response syndrome (SIRS) criteria, were trained in the use of TATs and hand-held lactate meters, and enrolled patients who had a recent history of infection, met ≥ 2 SIRS criteria, and were being transported to a participating hospital. Blood lactate was measured by paramedics in the prehospital setting and again in the emergency department (ED) via usual care. Paramedics entered data using an online database accessible at the point of care. Results: Prehospital lactate values obtained by paramedics ranged from 0.8 to 9.8 mmol/L, and an elevated lactate (i.e. ≥ 4.0) was documented in 13 of 112 enrolled patients (12%). The unadjusted correlation of prehospital and ED lactate values was 0.57 (pl 0.001). The median interval between paramedic assessment of blood lactate and the electronic posting of the ED-measured lactate value in the hospital record was 111 minutes. Overall, 91 patients (81%) were hospitalized after ED evaluation, 27 (24%) were ultimately diagnosed with sepsis, and 3 (3%) died during hospitalization. Subjects with elevated prehospital lactate were somewhat more likely to have been admitted to the intensive care unit (23% vs 15%) and to have been diagnosed with sepsis (38% vs 22%) than those with normal lactate levels, but these differences were not statistically significant. Conclusion: In this pilot, EMS use of a combination of objective SIRS criteria, subjective assessment of infection, and blood lactate measurements did not achieve a level of diagnostic accuracy for sepsis that would warrant hospital prenotification and committed resources at a receiving hospital based on EMS assessment alone. Nevertheless, this work provides an early model for increasing EMS awareness and the implementation of novel devices that may enhance the prehospital assessment for sepsis. Additional translational research studies with larger numbers of patients and more robust methods are needed. [West J Emerg Med. 2016;17(5)648-655.]
- Published
- 2016
31. Burnout and Exposure to Critical Incidents in a Cohort of Emergency Medical Services Workers from Minnesota
- Author
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Pamela J. Mink, Russell N. Myers, Tyler G. Kinzy, Karl M. Fernstrom, Andrew C. Stevens, Lori L. Boland, and Jonathan W. Kamrud
- Subjects
Adult ,Male ,medicine.medical_specialty ,Emergency Medical Services ,Adolescent ,Cross-sectional study ,dispatcher ,Minnesota ,education ,lcsh:Medicine ,critical incidents ,Burnout ,Occupational burnout ,Cohort Studies ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Surveys and Questionnaires ,Depersonalization ,Emergency medical services ,Medicine ,Humans ,030212 general & internal medicine ,Emotional exhaustion ,Burnout, Professional ,Original Research ,burnout ,business.industry ,lcsh:R ,lcsh:Medical emergencies. Critical care. Intensive care. First aid ,030208 emergency & critical care medicine ,emergency medical services ,General Medicine ,lcsh:RC86-88.9 ,Middle Aged ,paramedic ,Emergency Medical Dispatcher ,Distress ,Emergency Medical Technicians ,Cross-Sectional Studies ,Logistic Models ,Family medicine ,Emergency Medicine ,Absenteeism ,Female ,medicine.symptom ,business - Abstract
Author(s): Boland, Lori L.; Kinzy, Tyler G.; Myers, Russell N.; Fernstrom, Karl M.; Kamrud, Jonathan W.; Mink, Pamela J.; Stevens, Andrew C. | Abstract: Introduction: Very little quantitative data on occupational burnout and exposure to critical incidents are available from contemporary United States emergency medical services (EMS) cohorts. Given that burnout has been associated positively with turnover intentions and absenteeism in EMS workers, studies that uncover correlates of burnout may be integral to combating growing concerns around retention in the profession. Methods: We administered a 167-item electronic survey that included the Maslach Burnout Inventory (MBI) and a modified version of the Critical Incident History Questionnaire (n=29 incident types) to paramedics, emergency medical technicians (EMTs), and dispatchers of a single ambulance service. We defined the presence of burnout as a high score on either the emotional exhaustion or depersonalization subscales of the MBI. Results: Survey respondents who provided regular 911 response at the time of the survey and completed the MBI portion of the survey were included in our analysis (190 paramedics/EMTs, 19 dispatchers; 54% response). The overall prevalence of burnout was 18%, with prevalence reaching 32% among dispatchers. The seven pediatric critical incident types presented in the survey accounted for seven of the top eight rated most difficult to cope with, and severity ratings for pediatric critical incidents did not differ by parental status (all pg0.30). A significant number of respondents reported that they had been threatened with a gun/weapon (43%) or assaulted by a patient (68%) at least once while on duty. Being over the age of 50, a parent, or in a committed relationship was associated with reduced odds of burnout in unadjusted models; however, these associations did not remain statistically significant in multivariate analysis. Increasing tertile of career exposure to critical incidents was not associated with burnout.Conclusion: Medical dispatchers may be an EMS subgroup particularly susceptible to burnout. These data also demonstrate quantitatively that in this EMS agency, responders find pediatric critical incidents especially distressing and that violence against responders is commonplace. In this study, a simple measure of career exposure to potentially critical incidents was not associated with burnout; however, individual reactions to incidents are heterogeneous, and assessment tools that more accurately enumerate encounters that result in distress are needed.
- Published
- 2018
32. Discontinuation of disease-modifying therapy in patients with multiple sclerosis over age 60
- Author
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Le H. Hua, Tyler G. Kinzy, Tracey H Fan, Devon S. Conway, and Nicolas R. Thompson
- Subjects
Male ,Treatment response ,medicine.medical_specialty ,Aging ,Multiple Sclerosis ,Disease ,03 medical and health sciences ,0302 clinical medicine ,Multiple Sclerosis, Relapsing-Remitting ,Recurrence ,Internal medicine ,Long term management ,medicine ,Humans ,In patient ,030212 general & internal medicine ,Patient Reported Outcome Measures ,Aged ,Retrospective Studies ,Proportional hazards model ,business.industry ,Multiple sclerosis ,Glatiramer Acetate ,Middle Aged ,medicine.disease ,Discontinuation ,Neurology ,Disease Progression ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
Background: The risk–benefit ratio of continuing immunomodulating disease-modifying therapy (DMT) in older multiple sclerosis (MS) patients is unknown. Objective: To evaluate clinical and patient-reported outcomes after stopping DMT in older MS patients. Methods: Retrospective, observational study identifying patients from our MS clinics who were aged over 60 and on DMT > 2 years. Cause-specific Cox proportional hazards regression modeled time to discontinuation and time to reinitiation of therapy. Pre- and post-discontinuation comparisons of Performance Scales (PS), Timed 25-Foot Walk, and Patient Health Questionnaire-9 (PHQ9) were analyzed using linear mixed models. Results: A total of 600 patients were included, with 178 (29.7%) discontinuing. Discontinuers were 2.2 years older, had 3.2 years longer disease duration, and 1.6 years lesser treatment exposure. Providers initiated discontinuation more than patients (68.0%). Only one clinical relapse occurred in discontinuers. A proportion (10.7%) reinitiated DMT. Provider-initiated discontinuers restarted less often (hazard ratio (HR): 0.34; 95% confidence interval (CI): 0.12–0.9). In discontinuers, relapsing-remitting patients had lower PS on average than primary progressive. Provider-initiated discontinuation was associated with lower PS than patient- initiated discontinuation. PHQ9 scores appeared higher in those stopping intravenous (IV) therapies than interferons. Lower PS and PHQ9 indicate better outcomes. Conclusion: Most patients over age 60, who discontinued DMT, remained off DMT. This study provides real-world data that may guide clinicians considering discontinuing DMT.
- Published
- 2018
33. 0929 Relationship between PROMIS Global Health and High-Risk Obstructive Sleep Apnea/Moderate-to-Severe Insomnia Symptoms in Epilepsy
- Author
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Nancy Foldvary-Schaefer, Harneet K. Walia, Edward D Kaye, Tyler G. Kinzy, and Irene L. Katzan
- Subjects
medicine.medical_specialty ,Pediatrics ,business.industry ,medicine.disease ,Mental health ,Obstructive sleep apnea ,Epilepsy ,Quality of life ,Physiology (medical) ,Severity of illness ,Global health ,Insomnia ,Medicine ,Neurology (clinical) ,medicine.symptom ,Outcomes research ,business - Published
- 2019
34. Attitudinal barriers to participation in oncology clinical trials: factor analysis and correlates of barriers
- Author
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Nancy Roach, Sharon L. Manne, Terrance L. Albrecht, Suzanne M. Miller, Al B. Benson, Joanne S. Buzaglo, Deborah A. Kashy, Tasnuva M. Liu, Michael P. Collins, Yu-Ning Wong, Neal J. Meropol, Dawn M. Miller, Eric A. Ross, Linda Fleisher, Mira L. Katz, Stephanie Raivitch, A. Lederman Flamm, David Poole, and Tyler G. Kinzy
- Subjects
Oncology ,medicine.medical_specialty ,Cancer clinical trial ,business.industry ,media_common.quotation_subject ,Single factor ,Alternative medicine ,Disease ,Clinical trial ,Internal medicine ,medicine ,Health insurance ,Patient participation ,Worry ,business ,media_common - Abstract
Patient participation in cancer clinical trials is low. Little is known about attitudinal barriers to participation, particularly among patients who may be offered a trial during an imminent initial oncology consult. The aims of the present study were to confirm the presence of proposed subscales of a recently developed cancer clinical trial attitudinal barriers measure, describe the most common cancer clinical trials attitudinal barriers, and evaluate socio-demographic, medical and financial factors associated with attitudinal barriers. A total of 1256 patients completed a survey assessing demographic factors, perceived financial burden, prior trial participation and attitudinal barriers to clinical trials participation. Results of a factor analysis did not confirm the presence of the proposed four attitudinal barriers subscale/factors. Rather, a single factor represented the best fit to the data. The most highly-rated barriers were fear of side-effects, worry about health insurance and efficacy concerns. Results suggested that less educated patients, patients with non-metastatic disease, patients with no previous oncology clinical trial participation, and patients reporting greater perceived financial burden from cancer care were associated with higher barriers. These patients may need extra attention in terms of decisional support. Overall, patients with fewer personal resources (education, financial issues) report more attitudinal barriers and should be targeted for additional decisional support.
- Published
- 2014
35. 0600 Impact of Group-Based Sleep Apnea Management Intervention on Patient Reported Outcomes in Patients on Positive Airway Pressure for Obstructive Sleep Apnea
- Author
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Douglas E. Moul, Reena Mehra, Tina Campean, Nancy Foldvary-Schaefer, Tyler G. Kinzy, Robon Vanek, Harneet K. Walia, and M Syed
- Subjects
Obstructive sleep apnea ,Group based ,Management intervention ,business.industry ,Physiology (medical) ,Anesthesia ,Positive airway pressure ,medicine ,Sleep apnea ,In patient ,Neurology (clinical) ,medicine.disease ,business - Published
- 2018
36. Knowledge, Attitudes, and Self-efficacy as Predictors of Preparedness for Oncology Clinical Trials
- Author
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Neal J. Meropol, Joanne S. Buzaglo, Deborah A. Kashy, Al B. Benson, Tasnuva M. Liu, Suzanne M. Miller, Anne L. Flamm, Michael P. Collins, David Poole, Linda Fleisher, Sharon L. Manne, Stephanie Raivitch, Eric A. Ross, Tyler G. Kinzy, Dawn M. Miller, Yu-Ning Wong, Terrance L. Albrecht, Nancy Roach, and Michael Katz
- Subjects
Male ,Health Knowledge, Attitudes, Practice ,Decision support system ,medicine.medical_specialty ,Research Subjects ,Cancer clinical trial ,Article ,Sex Factors ,Nursing ,Sex factors ,Neoplasms ,Humans ,Medicine ,Aged ,Self-efficacy ,Clinical Trials as Topic ,business.industry ,Health Policy ,Age Factors ,Middle Aged ,Self Efficacy ,Clinical trial ,Family medicine ,Preparedness ,Female ,business - Abstract
Objective. This study used the Ottawa Decision Support Framework to evaluate a model examining associations between clinical trial knowledge, attitudinal barriers to participating in clinical trials, clinical trial self-efficacy, and clinical trial preparedness among 1256 cancer patients seen for their first outpatient consultation at a cancer center. As an exploratory aim, moderator effects for gender, race/ethnicity, education, and metastatic status on associations in the model were evaluated. Methods. Patients completed measures of cancer clinical trial knowledge, attitudinal barriers, self-efficacy, and preparedness. Structural equation modeling (SEM) was conducted to evaluate whether self-efficacy mediated the association between knowledge and barriers with preparedness. Results. The SEM explained 26% of the variance in cancer clinical trial preparedness. Self-efficacy mediated the associations between attitudinal barriers and preparedness, but self-efficacy did not mediate the knowledge-preparedness relationship. Conclusions. Findings partially support the Ottawa Decision Support Framework and suggest that assessing patients’ level of self-efficacy may be just as important as evaluating their knowledge and attitudes about cancer clinical trials.
- Published
- 2013
37. Postoperative respiratory failure necessitating transfer to the intensive care unit in orthopedic surgery patients: risk factors, costs, and outcomes
- Author
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Tyler G. Kinzy, Lori L. Boland, Molly A. McNaughton, Rebecca M. Prenevost, Lindsay Y. Hur, Joseph Huguelet, Mehdi Dastrange, James P. Normington, Leslie F. Maynard, Roman Melamed, and Adnan Masood
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Respiratory failure ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,030202 anesthesiology ,law ,Critical care nursing ,Intensive care unit transfer ,Medicine ,Critical care medicine ,Risk factor ,Intensive care medicine ,Mechanical ventilation ,COPD ,business.industry ,Research ,Orthopedic procedure ,General Medicine ,medicine.disease ,Intensive care unit ,Obstructive sleep apnea ,In-hospital ,Emergency medicine ,Orthopedic surgery ,business ,030217 neurology & neurosurgery - Abstract
Background Postoperative pulmonary complications in orthopedic surgery patients have been associated with worse clinical outcomes. Identifying patients with respiratory risk factors requiring enhanced monitoring and management modifications is an important part of postoperative care. Patients with unanticipated respiratory decompensation requiring transfer to the intensive care unit (ICU) have not been studied in sufficient detail. Methods A retrospective case-control study of elective orthopedic surgery patients (knee, hip, shoulder, or spine, n = 51) who developed unanticipated respiratory failure (RF) necessitating transfer to the ICU over a 3-year period was conducted. Controls (n = 153) were frequency matched to cases by gender, age, and surgical procedure. Patient and perioperative care factors, clinical outcomes, and cost of care were examined. Results Transfer to the ICU occurred within 48 h of surgery in 73 % of the cases, 31 % required non-invasive ventilation, and 18 % required mechanical ventilation. Cases had a higher prevalence of chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA), and regular psychotropic medication use than controls. Cases received more intravenous opioids during the first 24 postoperative hours, were hospitalized 4 days longer, had higher in-hospital mortality, and had excess hospitalization costs of US$26,571. COPD, OSA, preoperative psychotropic medications, and anesthesia time were associated with risk of RF in a multivariate analysis. Conclusions Unanticipated RF after orthopedic surgery is associated with extended hospitalization, increased mortality, and higher cost of care. Hospital protocols that include risk factor assessment, enhanced monitoring, and a cautious approach to opioid use in high-risk patients may reduce the frequency of this complication.
- Published
- 2016
38. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials
- Author
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Tyler G. Kinzy, Linda Fleisher, Joanne S. Buzaglo, David Poole, Al B. Benson, Michael Katz, Michael Collins, Terrance L. Albrecht, Brian L. Egleston, Dawn M. Miller, Tasnuva M. Liu, Mark D. Schluchter, Anne L. Flamm, Yu-Ning Wong, Seunghee Margevicius, Neal J. Meropol, Suzanne M. Miller, Nancy Roach, Sharon L. Manne, and Eric Ross
- Subjects
Male ,Cancer Research ,medicine.medical_specialty ,Decision Making ,Alternative medicine ,MEDLINE ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Patient Education as Topic ,law ,Intervention (counseling) ,Neoplasms ,Surveys and Questionnaires ,medicine ,Early Intervention, Educational ,Humans ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,Health communication ,Aged ,Clinical Trials as Topic ,Internet ,business.industry ,Case-control study ,ORIGINAL REPORTS ,Middle Aged ,Prognosis ,National Cancer Institute (U.S.) ,United States ,Clinical trial ,Oncology ,Health Communication ,030220 oncology & carcinogenesis ,Case-Control Studies ,Physical therapy ,Female ,business ,Follow-Up Studies - Abstract
Purpose Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. Patients and Methods A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient’s barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Results Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. Conclusion These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers.
- Published
- 2015
39. Financial Concerns About Participation in Clinical Trials Among Patients With Cancer
- Author
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Joanne S. Buzaglo, Al B. Benson, Linda Fleisher, Eric Ross, Neal J. Meropol, Suzanne M. Miller, Michael Katz, Anne L. Flamm, Nancy Roach, Mark D. Schluchter, Tasnuva M. Liu, Stephanie Raivitch, Sharon L. Manne, Yu-Ning Wong, Michael Collins, Terrance L. Albrecht, David Poole, Seunghee Margevicius, Dawn M. Miller, and Tyler G. Kinzy
- Subjects
Male ,Cancer Research ,medicine.medical_specialty ,Health Knowledge, Attitudes, Practice ,Decision Making ,Alternative medicine ,MEDLINE ,Likert scale ,law.invention ,Decision Support Techniques ,Conflict, Psychological ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Patient Education as Topic ,law ,Neoplasms ,Surveys and Questionnaires ,Medicine ,Humans ,030212 general & internal medicine ,Patient participation ,Aged ,Finance ,Self-efficacy ,Clinical Trials as Topic ,business.industry ,Secondary data ,ORIGINAL REPORTS ,Self Efficacy ,Clinical trial ,Oncology ,030220 oncology & carcinogenesis ,Female ,Patient Participation ,business - Abstract
Purpose The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. Methods We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): “How much of a burden on you is the cost of your medical care?,” “I'm afraid that my health insurance won't pay for a clinical trial,” and “I’m worried that I wouldn’t be able to afford the costs of treatment on a clinical trial.” Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. Results One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). Conclusion Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients’ financial needs and concerns may reduce distress and improve patient decision making.
- Published
- 2015
40. 0485 FEASIBILITY AND PREVALENCE OF HIGH RISK OBSTRUCTIVE SLEEP APNEA AND INSOMNIA ASCERTAINED BY STOP AND INSOMNIA SEVERITY INDEX IN NEUROLOGICAL DISORDERS: A NOVEL PRELIMINARY EXPERIENCE IN A TERTIARY CARE CENTER
- Author
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Irene L. Katzan, Tyler G. Kinzy, Harneet K. Walia, and Nancy Foldvary-Schaefer
- Subjects
Obstructive sleep apnea ,medicine.medical_specialty ,business.industry ,Physiology (medical) ,Physical therapy ,Insomnia ,Medicine ,Neurology (clinical) ,medicine.symptom ,business ,medicine.disease ,Tertiary care ,Insomnia severity index - Published
- 2017
41. Application of best practice approaches for designing decision support tools: the preparatory education about clinical trials (PRE-ACT) study
- Author
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Jennifer Millard, Cheri Manning, Michael Collins, Dominique G Ruggieri, Terrance L. Albrecht, Sharon L. Manne, Linda Fleisher, Suzanne M. Miller, Tasnuva M. Liu, Nancy Roach, Eric A. Ross, Stephanie Raivitch, Neal J. Meropol, Joanne S. Buzaglo, Dawn M. Miller, Michael Katz, Ellyn Charap, David Poole, and Tyler G. Kinzy
- Subjects
Male ,medicine.medical_specialty ,Process (engineering) ,Best practice ,Decision Making ,Alternative medicine ,Article ,Decision Support Techniques ,Patient Education as Topic ,Intervention (counseling) ,Neoplasms ,Patient-Centered Care ,medicine ,Decision aids ,Humans ,Patient participation ,Patient Care Team ,Medical education ,Clinical Trials as Topic ,business.industry ,General Medicine ,Benchmarking ,Decision Support Systems, Clinical ,Clinical trial ,Female ,Patient Participation ,business - Abstract
This article describes the rigorous development process and initial feedback of the PRE-ACT (Preparatory Education About Clinical Trials) web-based- intervention designed to improve preparation for decision making in cancer clinical trials.The multi-step process included stakeholder input, formative research, user testing and feedback. Diverse teams (researchers, advocates and developers) participated including content refinement, identification of actors, and development of video scripts. Patient feedback was provided in the final production period and through a vanguard group (N=100) from the randomized trial.Patients/advocates confirmed barriers to cancer clinical trial participation, including lack of awareness and knowledge, fear of side effects, logistical concerns, and mistrust. Patients indicated they liked the tool's user-friendly nature, the organized and comprehensive presentation of the subject matter, and the clarity of the videos.The development process serves as an example of operationalizing best practice approaches and highlights the value of a multi-disciplinary team to develop a theory-based, sophisticated tool that patients found useful in their decision making process. Practice implications Best practice approaches can be addressed and are important to ensure evidence-based tools that are of value to patients and supports the usefulness of a process map in the development of e-health tools.
- Published
- 2013
42. Randomized trial of a web-based intervention to address barriers to clinical trials
- Author
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Neal J. Meropol, Terrance Lynn Albrecht, Yu-Ning Wong, Al Bowen Benson, Joanne S. Buzaglo, Michael Collins, Jennifer Rachel Eads, Brian Egleston, Anne Lederman Flamm, Linda Fleisher, Michael S. Katz, Tyler G. Kinzy, Sharon Manne, Seunghee Margevicius, Dawn M. Miller, Suzanne M. Miller, David Poole, Nancy Roach, Eric A Ross, and Mark D. Schluchter
- Subjects
Cancer Research ,Oncology - Abstract
6500 Background: Cancer patients (pts) have knowledge and attitudinal barriers to participation in clinical trials (CT). We developed PRE-ACT (Preparatory Education About Clinical Trials), a tailored, interactive, web-based intervention to address these barriers and improve preparation for consideration of CT as a treatment option. Methods: We conducted a prospective, randomized, multicenter, phase III clinical trial of PRE-ACT vs. control (general text about CT excerpted from NCI materials). All assessments and interventions were conducted online. Cancer pts >18 years old were enrolled before initial oncologist consultation. Pts completed a baseline assessment including CT knowledge (19-item); CT attitudes (28-item); preparation for decision making (10-item); and validated measures of preferences for shared decision making and quality/length of life. PRE-ACT pts received a summary of their preferences and a list of their top CT barriers. Based on ranking of individual barriers, pts were presented with a video library of 30-90 second clips addressing their top barriers (10 maximum). After the educational intervention a follow up survey reassessed CT barriers and preparation. Results: 1255 pts were randomized; median age 59 (range 20-88); 58% female; 12% non-white / 2% Hispanic; 76.4% some college education. 1081 pts completed baseline and post-intervention assessments. The control and PRE-ACT groups both had improved knowledge, reduced attitudinal barriers, and improved preparation (p
- Published
- 2013
43. Health care worker attitudes about clinical trials at a comprehensive cancer center
- Author
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Jennifer R. Eads, Erica L. Campagnaro, Tyler G. Kinzy, Seunghee Margevicius, Barbara J. Daly, Mark Schluchter, Neal J. Meropol, Sharon L. Manne, Tasnuva Munir Liu, and Dawn M. Miller
- Subjects
Cancer Research ,medicine.medical_specialty ,business.industry ,Alternative medicine ,Psychological intervention ,Theory of planned behavior ,Cancer ,medicine.disease ,Likert scale ,Clinical trial ,Oncology ,Family medicine ,Health care ,medicine ,Normative ,business - Abstract
e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.
- Published
- 2013
44. Identification of barriers to clinical trials: The impact of education level
- Author
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Tyler G. Kinzy, Jennifer R. Eads, Brian L. Egleston, Terrance L. Albrecht, Linda Fleisher, Neal J. Meropol, Dawn M. Miller, Stephanie Raivitch, Suzanne M. Miller, Roger B. Cohen, Tanina Foster, Mira L. Katz, Nancy Roach, A. Silver, Sharon L. Manne, and Joanne S. Buzaglo
- Subjects
Clinical trial ,Cancer Research ,medicine.medical_specialty ,Oncology ,business.industry ,Family medicine ,Alternative medicine ,Medicine ,Identification (biology) ,business ,Psychosocial - Abstract
6003 Background: Patient (pt) participation in clinical trials remains low. We previously described psychosocial and practical barriers to enrollment (J NCCN, 2007). During development of an interv...
- Published
- 2011
45. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.
- Author
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Meropol NJ, Wong YN, Albrecht T, Manne S, Miller SM, Flamm AL, Benson AB 3rd, Buzaglo J, Collins M, Egleston B, Fleisher L, Katz M, Kinzy TG, Liu TM, Margevicius S, Miller DM, Poole D, Roach N, Ross E, and Schluchter MD
- Subjects
- Aged, Case-Control Studies, Female, Follow-Up Studies, Health Communication, Humans, Male, Middle Aged, National Cancer Institute (U.S.), Prognosis, Prospective Studies, Surveys and Questionnaires, United States, Clinical Trials as Topic methods, Decision Making, Early Intervention, Educational, Internet statistics & numerical data, Neoplasms prevention & control, Patient Education as Topic methods
- Abstract
Purpose: Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option., Patients and Methods: A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials., Results: Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone., Conclusion: These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers., Competing Interests: Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article., (© 2015 by American Society of Clinical Oncology.)
- Published
- 2016
- Full Text
- View/download PDF
46. Financial Concerns About Participation in Clinical Trials Among Patients With Cancer.
- Author
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Wong YN, Schluchter MD, Albrecht TL, Benson AB 3rd, Buzaglo J, Collins M, Flamm AL, Fleisher L, Katz M, Kinzy TG, Liu TM, Manne S, Margevicius S, Miller DM, Miller SM, Poole D, Raivitch S, Roach N, Ross E, and Meropol NJ
- Subjects
- Aged, Conflict, Psychological, Decision Making, Female, Health Knowledge, Attitudes, Practice, Humans, Male, Neoplasms psychology, Self Efficacy, Surveys and Questionnaires, Clinical Trials as Topic economics, Clinical Trials as Topic psychology, Decision Support Techniques, Neoplasms economics, Neoplasms therapy, Patient Education as Topic methods, Patient Participation psychology
- Abstract
Purpose: The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials., Methods: We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): "How much of a burden on you is the cost of your medical care?," "I'm afraid that my health insurance won't pay for a clinical trial," and "I'm worried that I wouldn't be able to afford the costs of treatment on a clinical trial." Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics., Results: One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models)., Conclusion: Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients' financial needs and concerns may reduce distress and improve patient decision making., Competing Interests: Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article., (© 2015 by American Society of Clinical Oncology.)
- Published
- 2016
- Full Text
- View/download PDF
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