Browsing by Subject "Bias"
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Item Open Access A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.(Trials, 2014-01) Goswami, Neela D; Tsalik, Ephraim L; Naggie, Susanna; Miller, William C; Horton, John R; Pfeiffer, Christopher D; Hicks, Charles BBackground
The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves.Methods
We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition.Results
The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials.Conclusions
No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.Item Open Access A Theory and Test of How Speakers with Nonnative Accents are Evaluated in Entrepreneurial Settings(2016) Zhou Koval, ChristyAn abundance of research in the social sciences has demonstrated a persistent bias against nonnative English speakers (Giles & Billings, 2004; Gluszek & Dovidio, 2010). Yet, organizational scholars have only begun to investigate the underlying mechanisms that drive the bias against nonnative speakers and subsequently design interventions to mitigate these biases. In this dissertation, I offer an integrative model to organize past explanations for accent-based bias into a coherent framework, and posit that nonnative accents elicit social perceptions that have implications at the personal, relational, and group level. I also seek to complement the existing emphasis on main effects of accents, which focuses on the general tendency to discriminate against those with accents, by examining moderators that shed light on the conditions under which accent-based bias is most likely to occur. Specifically, I explore the idea that people’s beliefs about the controllability of accents can moderate their evaluations toward nonnative speakers, such that those who believe that accents can be controlled are more likely to demonstrate a bias against nonnative speakers. I empirically test my theoretical model in three studies in the context of entrepreneurial funding decisions. Results generally supported the proposed model. By examining the micro foundations of accent-based bias, the ideas explored in this dissertation set the stage for future research in an increasingly multilingual world.
Item Open Access An item response theory modeling of alcohol and marijuana dependences: a National Drug Abuse Treatment Clinical Trials Network study.(Journal of studies on alcohol and drugs, 2009-05) Wu, Li-Tzy; Pan, Jeng-Jong; Blazer, Dan G; Tai, Betty; Stitzer, Maxine L; Brooner, Robert K; Woody, George E; Patkar, Ashwin A; Blaine, Jack DOBJECTIVE:The aim of this study was to examine psychometric properties of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnostics criteria for alcohol and marijuana dependences among 462 alcohol users and 311 marijuana users enrolled in two multisite trials of the National Drug Abuse Treatment Clinical Trials Network. METHOD:Diagnostic questions were assessed by the DSM-IV checklist. Data were analyzed by the item response theory and the multiple indicators-multiple causes method procedures. RESULTS:Criterion symptoms of alcohol and marijuana dependences exhibited a high level of internal consistency. All individual symptoms showed good discrimination in distinguishing alcohol or marijuana users between high and low severity levels of the continuum. In both groups, "withdrawal" appeared to measure the most severe symptom of the dependence continuum. There was little evidence of measurement nonequivalence in assessing symptoms of dependence by gender, age, race/ethnicity, and educational level. CONCLUSIONS:These findings highlight the clinical utility of the DSM-IV checklist in assessing alcohol- and marijuana dependence syndromes among treatment-seeking substance users.Item Open Access Beyond the burn: Studies on the physiological effects of flamethrowers during World War II.(Military Medical Research, 2020-02) Van Wyck, David WFlamethrowers are widely considered one of warfare's most controversial weapons and are capable of inflicting gruesome physical injuries and intense psychological trauma. Despite being the last of the major combatants in World War II (WWII) to develop them, the United States military quickly became the most frequent and adept operator of portable flamethrowers. This gave the U.S. military ample opportunity to observe the effects of flamethrowers on enemy soldiers. However, while most people in modern times would consider immolation by flamethrower to be an unnecessarily painful and inhumane way to inflict casualties, immolation was, at one point during World War II (WWII), referred to as "mercy killing" by the U.S. Chemical Warfare Service (CWS). This mischaracterization arose from a series of first-hand accounts describing what were believed to be quick, painless, and unmarred deaths, as well as from a poor and incomplete understanding of flamethrower lethality. As a result, indirect mechanisms such as hypoxia and carbon monoxide poisoning were generally absent from accounts of the flamethrower's fatal effects. It was not until several years after flamethrowers were introduced to the frontlines that the CWS and National Defense Research Committee (NDRC) conducted a series of tests to better understand the physiological and toxicological effects of flamethrowers. This article examines how the initial absence of scientific data on the physiologic effects of flamethrowers led to an inaccurate understanding of their lethality, and bizarre claims that one of history's most horrific instruments of war was considered one of the more "humane" weapons on the battlefield.Item Open Access Chapter 5: assessing risk of bias as a domain of quality in medical test studies.(Journal of general internal medicine, 2012-06) Santaguida, P Lina; Riley, Crystal M; Matchar, David BAssessing methodological quality is a necessary activity for any systematic review, including those evaluating the evidence for studies of medical test performance. Judging the overall quality of an individual study involves examining the size of the study, the direction and degree of findings, the relevance of the study, and the risk of bias in the form of systematic error, internal validity, and other study limitations. In this chapter of the Methods Guide for Medical Test Reviews, we focus on the evaluation of risk of bias in the form of systematic error in an individual study as a distinctly important component of quality in studies of medical test performance, specifically in the context of estimating test performance (sensitivity and specificity). We make the following recommendations to systematic reviewers: 1) When assessing study limitations that are relevant to the test under evaluation, reviewers should select validated criteria that examine the risk of systematic error, 2) categorizing the risk of bias for individual studies as "low," "medium," or "high" is a useful way to proceed, and 3) methods for determining an overall categorization for the study limitations should be established a priori and documented clearly.Item Open Access Essays on Education Policy(2013) Francis, Dania VeronicaThis dissertation consists of three essays on the topic of education policy. In the first essay, I evaluate the impacts of a teacher quality equity law that was enacted in California in the fall of 2006 prohibiting superintendents from transferring a teacher into a school in the bottom three performance deciles of the state's academic performance index if the principal refuses the transfer. The primary mechanism through which the policy should affect student outcomes is through the mix of the quality of teachers in the school. Using publicly available statewide administrative education data, and two quasi-experimental methodologies, I assess whether the policy had an effect on the district-wide distribution of teachers with varying levels of experience, education and licensure and on student academic performance. I extend the analysis by examining whether the policy has differential effects on subgroups of schools classified as having high-poverty or high-minority student populations. I find that, as a result of the teacher quality equity law, low-performing schools experienced a relative increase in fully-credentialed teachers and more highly educated teachers, but that did not necessarily translate to an increase in academic performance. I also find evidence that the dimension along which the policy was most effective was in improving teacher pre-service qualifications in schools with high minority student populations.
In the second essay, I estimate racial, ethnic, gender and socioeconomic differences in teacher reports of student absenteeism and tardiness while controlling for administrative records of actual absences. Subjective perceptions that teachers form about students' classroom behaviors matter for student academic outcomes. Given this potential impact, it is important to identify any biases in these perceptions that would disadvantage subgroups of students. I use longitudinal data from the Early Childhood Longitudinal Study, Kindergarten Class of 1998-99 in conjunction with longitudinal, student-level data from the North Carolina Education Data Research Center to employ a variation of a two sample instrumental variables approach in which I instrument for actual eighth grade absences with simulated measures of eight grade absences. I find consistent evidence that teacher reports of the attendance of poor students are negatively biased and that math teacher reports of male attendance are positively biased. There is mixed evidence with regard to student race and ethnicity.
The third essay is a co-authored work in which we employ a quasi-experimental estimation strategy to examine the effects of state-level job losses on fourth- and eighth-grade test scores, using federal Mass Layoff Statistics and 1996-2009 National Assessment of Educational Progress data. Results indicate that job losses decrease scores. Effects are larger for eighth than fourth graders and for math than reading assessments, and are robust to specification checks. Job losses to 1 percent of a state's working-age population lead to a .076 standard deviation decrease in the state's eighth-grade math scores. This result is an order of magnitude larger than those found in previous studies that have compared students whose parents lose employment to otherwise similar students, suggesting that downturns affect all students, not just students who experience parental job loss. Our findings have important implications for accountability schemes: we calculate that a state experiencing one-year job losses to 2 percent of its workers (a magnitude observed in seven states) likely sees a 16 percent increase in the share of its schools failing to make Adequate Yearly Progress under No Child Left Behind.
Item Open Access Metrology Standards for Quantitative Imaging Biomarkers.(Radiology, 2015-12) Sullivan, Daniel C; Obuchowski, Nancy A; Kessler, Larry G; Raunig, David L; Gatsonis, Constantine; Huang, Erich P; Kondratovich, Marina; McShane, Lisa M; Reeves, Anthony P; Barboriak, Daniel P; Guimaraes, Alexander R; Wahl, Richard L; RSNA-QIBA Metrology Working GroupAlthough investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by the inconsistent or incorrect use of terminology or methods for technical performance and statistical concepts. Technical performance is an assessment of how a test performs in reference objects or subjects under controlled conditions. In this article, some of the relevant statistical concepts are reviewed, methods that can be used for evaluating and comparing QIBs are described, and some of the technical performance issues related to imaging biomarkers are discussed. More consistent and correct use of terminology and study design principles will improve clinical research, advance regulatory science, and foster better care for patients who undergo imaging studies.Item Open Access Navigating Heroic Expectations: How Positive Stereotypes Impact Veterans’ Occupational Outcomes(2024) Lewis, Charles EdwardIn American culture, military service is often revered and celebrated, yet veterans frequently face higher rates of unemployment and underemployment compared to non-veterans. To delve into this phenomenon, our research draws on theories of positive stereotypes and negotiation to explore how seemingly favorable perceptions might disadvantage veterans in the hiring process. Through eight studies, we uncover a pervasive belief among the general public that veterans are not subject to hiring disadvantages, despite evidence to the contrary (Barrera & Carter, 2017; Boatwright & Roberts, 2020). While individuals generally regard veterans as desirable hires deserving equal compensation to non-veterans, they also perceive veterans as more likely to accept lower starting salaries than their non-veteran counterparts. Consequently, this belief leads to lower salary offers, potentially impacting veterans' future earnings and job satisfaction. Additionally, our findings suggest a perception that veterans are less inclined to negotiate compared to non-veterans, further complicating their employment prospects. Finally, our investigation into the influence of negotiation and veteran status on likability and perceived fit for leadership roles reveals a nuanced dynamic wherein negotiation diminishes likability and perceived fit for leadership type roles, particularly for veterans. Our research highlights a real-world scenario where the adverse effects of positive stereotypes on veterans may be overlooked, underscoring the need for greater awareness and scrutiny of such biases in employment practices.
Item Open Access Reduction of Internalized Weight Bias via Mindful Self-compassion: Theoretical Framework and Results from a Randomized Controlled Trial(2022) Hopkins, ChristinaWeight bias internalization is considered a chronic discriminatory stressor and a threat to health. Weight bias internalization has known associations with health-depleting behaviors (i.e., disordered eating, social isolation) and avoidance of health-promoting behaviors (i.e., physical activity, adherence to healthcare guidelines). Despite the numerous deleterious health effects of weight bias internalization, relatively few efficacious interventions have been identified for this critical treatment target. Self-compassion training presents itself as a potential intervention, though has not been rigorously tested in those with elevated internalized weight bias. Ruby was a two-arm randomized control designed to reduce internalized weight bias. Ruby tested the efficacy of a 4-week digitally-delivered self-compassion intervention compared to wait list control. Participants in the intervention group received daily text messages which included psychoeducation videos, writing prompts, and guided mindfulness audio files to facilitate daily mindful self-compassion practices ranging from 4-21 minutes per day. The main outcome of this trial was the 4-week reduction in weight bias internalization as measured by the Weight Bias Internalization Scale, compared to wait list control. Trial outcomes were analyzed using linear mixed models and one-way analysis of covariance models using an intent-to-treat framework. Ruby participants were 121 adults with elevated internalized weight bias (i.e., WBIS score > 4.0) and a body mass index over 30 kg/m2. Participants in the intervention demonstrated greater reductions in weight bias internalization compared to the wait list control (Net difference: -0.84, CI: -1.21 to -0.48, p < .0001). Participants in the intervention demonstrated similar reductions in secondary outcomes, including weight self-stigma, weight-related experiential avoidance, and fear of self-compassion (p’s < .05). Additionally, they reported increases in self-compassion, mindfulness, body appreciation, intuitive eating, and physical activity. Mediation analyses suggest that reductions in weight bias internalization are likely partially driven by increases in self-compassion. Ruby was the first digital standalone self-compassion based intervention targeting weight bias internalization. Results suggest that a brief mindful self-compassion intervention can meaningfully reduce internalized weight bias over 4 weeks. Additionally, a mindful self-compassion intervention can reduce several other secondary outcomes related to internalized weight bias. Due to its standalone digital delivery, Ruby may be a highly-scalable treatment for internalized weight bias that can be delivered on its own or combined with other treatments. Ruby is poised to expand a burgeoning body of literature related to psychological intervention for internalized weight bias.
Item Open Access Security Without Equity? The Effect of Secure Communities on Racial Profiling by Police(2015-04-14) Willoughby, JackAnecdotal and circumstantial evidence suggest that the implementation of Secure Communities, a federal program that allows police officers to more easily identify illegal immigrants, has increased racial bias by police. The goal of this analysis is to empirically evaluate the effect of Secure Communities on racial bias by police using motor vehicle stop and search data from the North Carolina State Bureau of Investigation. This objective differs from most previous research, which has largely attempted to quantify racial profiling for a moment in time rather than looking at how an event influences racial profiling. I examine the effects of Secure Communities on police treatment of Hispanics vs. whites with an expanded difference-in-difference approach that looks at outcomes in motor vehicle search success rate, search rate conditional on a police stop, stop rate, and police action conditional on stop. Statistical analyses yield no evidence that the ratification of Secure Communities increased racial profiling against Hispanics by police. This finding is at odds with the anecdotal and circumstantial evidence that has led many to believe that the ratification of Secure Communities led to a widespread increase in racial profiling by police, a discrepancy that should caution policy makers about making decisions driven by stories and summary statistics.Item Open Access The construct and measurement equivalence of cocaine and opioid dependences: a National Drug Abuse Treatment Clinical Trials Network (CTN) study.(Drug and alcohol dependence, 2009-08) Wu, Li-Tzy; Pan, Jeng-Jong; Blazer, Dan G; Tai, Betty; Brooner, Robert K; Stitzer, Maxine L; Patkar, Ashwin A; Blaine, Jack DINTRODUCTION:Although DSM-IV criteria are widely used in making diagnoses of substance use disorders, gaps exist regarding diagnosis classification, use of dependence criteria, and effects of measurement bias on diagnosis assessment. We examined the construct and measurement equivalence of diagnostic criteria for cocaine and opioid dependences, including whether each criterion maps onto the dependence construct, how well each criterion performs, how much information each contributes to a diagnosis, and whether symptom-endorsing is equivalent between demographic groups. METHODS:Item response theory (IRT) and multiple indicators-multiple causes (MIMIC) modeling were performed on a sample of stimulant-using methadone maintenance patients enrolled in a multisite study of the National Drug Abuse Treatment Clinical Trials Network (CTN) (N=383). Participants were recruited from six community-based methadone maintenance treatment programs associated with the CTN and major U.S. providers. Cocaine and opioid dependences were assessed by DSM-IV Checklist. RESULTS:IRT modeling showed that symptoms of cocaine and opioid dependences, respectively, were arrayed along a continuum of severity. All symptoms had moderate to high discrimination in distinguishing drug users between severity levels. "Withdrawal" identified the most severe symptom of the cocaine dependence continuum. MIMIC modeling revealed some support for measurement equivalence. CONCLUSIONS:Study results suggest that self-reported symptoms of cocaine and opioid dependences and their underlying constructs can be measured appropriately among treatment-seeking polysubstance users.Item Open Access The Impact of Racial Bias in Patient Care and Medical Education: Let's Focus on the Educator.(MedEdPORTAL : the journal of teaching and learning resources, 2021-01) Corsino, Leonor; Railey, Kenyon; Brooks, Katherine; Ostrovsky, Daniel; Pinheiro, Sandro O; McGhan-Johnson, Alyson; Padilla, Blanca IrisIntroduction
Racial bias in health care is well documented. Research shows the presence of racial bias among health care providers. There is a paucity of workshops focused on racial bias effects in health professions educators.Method
Two to three workshops were delivered to a diverse group of clinical educators from three programs at a major academic institution. Each workshop included a brief multimedia presentation followed by a facilitated group discussion. Participants completed the online Implicit Association Test (IAT), a baseline demographic questionnaire, and a brief post-then-pre questionnaire.Results
Twenty-four faculty participated in the study (six physicians, eight nurse practitioners, 10 physician assistants). Nineteen (90%) were women, 18 (86%) were White, nine (43%) had more than 10 years of experience as educators, and seven (35%) had previously participated in a biases program. Seventeen completed the IAT. Sixteen educators agreed or strongly agreed that bias has a significant impact on patients' outcomes at the end of the workshop compared to 17 before the workshop. Seventeen educators agreed or strongly agreed that recognizing their own racial bias would positively alter their teaching practice after the workshop compared to 15 before the workshop.Discussion
This series of workshops was created to fill a gap regarding the impact of racial bias on patient outcomes, health disparities, and health professions education. The impact of racial bias in health professions education and the long-term impact of awareness and knowledge of racial bias in education are areas needing further evaluation.Item Open Access Using a latent variable approach to inform gender and racial/ethnic differences in cocaine dependence: a National Drug Abuse Treatment Clinical Trials Network study.(Journal of substance abuse treatment, 2010-06) Wu, Li-Tzy; Pan, Jeng-Jong; Blazer, Dan G; Tai, Betty; Stitzer, Maxine L; Woody, George EThis study applies a latent variable approach to examine gender and racial/ethnic differences in cocaine dependence, to determine the presence of differential item functioning (DIF) or item-response bias to diagnostic questions of cocaine dependence, and to explore the effects of DIF on the predictor analysis of cocaine dependence. The analysis sample included 682 cocaine users enrolled in two national multisite studies of the National Drug Abuse Treatment Clinical Trials Network (CTN). Participants were recruited from 14 community-based substance abuse treatment programs associated with the CTN, including 6 methadone and 8 outpatient nonmethadone programs. Factor and multiple indicators-multiple causes (MIMIC) procedures evaluated the latent continuum of cocaine dependence and its correlates. MIMIC analysis showed that men exhibited lower odds of cocaine dependence than women (regression coefficient, beta = -0.34), controlling for the effects of DIF, years of cocaine use, addiction treatment history, comorbid drug dependence diagnoses, and treatment setting. There were no racial/ethnic differences in cocaine dependence; however, DIF by race/ethnicity was noted. Within the context of multiple community-based addiction treatment settings, women were more likely than men to exhibit cocaine dependence. Addiction treatment research needs to further evaluate gender-related differences in drug dependence in treatment entry and to investigate how these differences may affect study participation, retention, and treatment response to better serve this population.Item Open Access Von Uexküll Revisited: Addressing Human Biases in the Study of Animal Perception.(Integrative and comparative biology, 2019-12) Caves, Eleanor M; Nowicki, Stephen; Johnsen, SönkeMore than 100 years ago, the biologist Jakob von Uexküll suggested that, because sensory systems are diverse, animals likely inhabit different sensory worlds (umwelten) than we do. Since von Uexküll, work across sensory modalities has confirmed that animals sometimes perceive sensory information that humans cannot, and it is now well-established that one must account for this fact when studying an animal's behavior. We are less adept, however, at recognizing cases in which non-human animals may not detect or perceive stimuli the same way we do, which is our focus here. In particular, we discuss three ways in which our own perception can result in misinformed hypotheses about the function of various stimuli. In particular, we may (1) make untested assumptions about how sensory information is perceived, based on how we perceive or measure it, (2) attribute undue significance to stimuli that we perceive as complex or striking, and (3) assume that animals divide the sensory world in the same way that we as scientists do. We discuss each of these biases and provide examples of cases where animals cannot perceive or are not attending to stimuli in the same way that we do, and how this may lead us to mistaken assumptions. Because what an animal perceives affects its behavior, we argue that these biases are especially important for researchers in sensory ecology, cognition, and animal behavior and communication to consider. We suggest that studying animal umwelten requires integrative approaches that combine knowledge of sensory physiology with behavioral assays.