14 research outputs found

    Health Status among Emergency Department Patients Approximately One Year after Consecutive Disasters in New York City

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    Objectives: Emergency department (ED) patients with disaster-related experiences may present with vague symptoms not clearly linked to the event. In 2001, two disasters in New York City, the World Trade Center disaster (WTCD) and the subsequent American Airlines Flight 587 crash, presented an opportunity to study long-term consequences of cumulative disaster exposure (CDE) on health-related quality of life (HRQOL) among ED patients. Methods: From July 15 to October 30, 2002, a systematic sample of stable, adult patients from two EDs in New York City were enrolled. Participants completed a self-administered questionnaire. The Short Form 36 (SF-36) was used to assess overall health status. Bivariate analyses were conducted to identify individual correlates of worsening health status. Multivariate regression was performed to identify the association between various factors and overall health status, while controlling for relevant sociodemographic variables. Results: Four hundred seventy-one patients (54.6% female) participated. The participation rate was 73.4%. One hundred sixty-one participants (36%) reported direct, indirect, or occupational exposure to the WTCD; 55 (13.3%) had direct, indirect, or occupational exposure to the plane crash; 33 (8.1%) had both exposures. In separate multivariate models, CDE predicted lower SF-36 scores for general health (p , 0.0096), mental health (p , 0.0033), and bodily pain (p , 0.0046). Conclusions: In the year following mass traumatic events, persons with CDE had lower overall health status than those with one or no disaster exposure. Clinicians should consider the impact that traumatic events have on the overall health status of ED patients in the wake of consecutive disasters.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/40379/2/Fernandez_Health Status Among Emerency Department Patients_2005.pd

    Immunohistochemical expression of insulin-like growth factor binding protein-3 in invasive breast cancers and ductal carcinoma in situ: implications for clinicopathology and patient outcome

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    INTRODUCTION: Insulin-like growth factor binding protein-3 (IGFBP-3) differentially modulates breast epithelial cell growth through insulin-like growth factor (IGF)-dependent and IGF-independent pathways and is a direct (IGF-independent) growth inhibitor as well as a mitogen that potentiates EGF (epidermal growth factor) and interacts with HER-2. Previously, high IGFBP-3 levels in breast cancers have been determined by enzyme-linked immunosorbent assay and immunoradiometric assay methods. In vitro, IGFBP-3's mechanisms of action may involve cell membrane binding and nuclear translocation. To evaluate tumour-specific IGFBP-3 expression and its subcellular localisation, this study examined immunohistochemical IGFBP-3 expression in a series of invasive ductal breast cancers (IDCs) with synchronous ductal carcinomas in situ (DCIS) in relation to clinicopathological variables and patient outcome. METHODS: Immunohistochemical expression of IGFBP-3 was evaluated with the sheep polyclonal antiserum (developed in house) with staining performed as described previously. RESULTS: IGFBP-3 was evaluable in 101 patients with a variable pattern of cytoplasmic expression (positivity of 1+/2+ score) in 85% of invasive and 90% of DCIS components. Strong (2+) IGFBP-3 expression was evident in 32 IDCs and 40 cases of DCIS. A minority of invasive tumours (15%) and DCIS (10%) lacked IGFBP-3 expression. Nuclear IGFBP-3 expression was not detectable in either invasive cancers or DCIS, with a consistent similarity in IGFBP-3 immunoreactivity in IDCs and DCIS. Positive IGFBP-3 expression showed a possible trend in association with increased proliferation (P = 0.096), oestrogen receptor (ER) negativity (P = 0.06) and HER-2 overexpression (P = 0.065) in invasive tumours and a strong association with ER negativity (P = 0.037) in DCIS. Although IGFBP-3 expression was not an independent prognosticator, IGFBP-3-positive breast cancers may have shorter disease-free and overall survivals, although these did not reach statistical significance. CONCLUSIONS: Increased breast epithelial IGFBP-3 expression is a feature of tumorigenesis with cytoplasmic immunoreactivity in the absence of significant nuclear localisation in IDCs and DCIS. There are trends between high levels of IGFBP-3 and poor prognostic features, suggesting that IGFBP-3 is a potential mitogen. IGFBP-3 is not an independent prognosticator for overall survival or disease-free survival, to reflect its dual effects on breast cancer growth regulated by complex pathways in vivo that may relate to its interactions with other growth factors

    Wounding song: Integrating Maltese and Middle Eastern music into a western musical genre

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    I am an Australian-born composer of Maltese heritage; my musical compositions are expressions that contain elements of my dual upbringing. Maltese folk music (ghana) features components found in traditional Western music and music of the Middle East. Wounding Song is an opera that combines traditional Western music theory with elements of Middle Eastern music. The fusion of contrasting musical systems raises issues of theory, practice and cultural sensitivity. These issues must be addressed: first, to create a unified work that encompasses the disparate musical elements into a successful composition; and second, to ensure that they are used sensitively and appropriately in the dramatic and social context of the work. The present research addresses the theoretical and practical approach taken in combining the various musical elements for Wounding Song to achieve these goals. The elements addressed here include traditional Western harmony (major/minor scales and “church” modes), 12-tone serial methods, Middle Eastern/Turkish makams (comparable to scales in Western music theory) and Maltese folk songs. The successful fusion of these elements was achievable largely because much of the material shared common intervals. All the material was organised into trichords and tetrachords, which in turn generated the melodic and harmonic material for the entire work. Ultimately the scales, modes, makams and 12-tone rows were all generated from the same twelve notes of the chromatic scale, regardless of their particular arrangement or grouping. This common source of material supported the cohesiveness required. Wounding Song was performed at the Illawarra Performing Arts Centre in 2008. The result was a successful season in terms of both the quality of the performances and the work’s acceptance within the Maltese community, whose members supported the project from the beginning

    The Need to Track Payment Incentives to Participate in HIV Research

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    Providing incentives is an accepted and common practice in human subjects research, including clinical HIV research. While we know that financial incentives among similar studies can greatly vary, surprisingly little research exists on how to determine when such incentives are excessive or constitute an “undue inducement.” Multiple factors, such as risks and benefits, study procedures, study budget, historical precedent, recommendations from institutional review boards, advice from other investigators, and local regulations may influence decisions about appropriate incentives, but little empirical data exist about what incentives are offered to potential research participants. Rules for acceptable gifts, services, and compensation should consider study location and population, but without a clearer understanding of currently offered incentives and how these practices match up to ethical beliefs of appropriateness, we continue to follow perceived trends without critical assessment. Here, we present one potential approach to explore the impact of financial incentives on biomedical HIV research and to further clarify undue inducement: the development of a framework to support ethical decision-making about payment to participate. This framework is based on input from people living with HIV, biomedical HIV researchers, ethicists, former study participants, and IRB members and includes a database that allows for tracking payment practices

    Attitudes Toward Payment for Research Participation: Results from a U.S. Survey of People Living with HIV

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    Little is known about how payment affects individuals\u27 decisions to participate in HIV research. Using data from a U.S. survey of people living with HIV (N = 292), we examined potential research participants’ attitudes toward payment, perceived study risk based on payment amount, and preferred payment forms, and how these factors vary by sociodemographic characteristics. Most respondents agreed people should be paid for HIV research participation (96%) and said payment would shape their research participation decisions (80%). Men, less formally educated individuals, and members of some minoritized racial-ethnic groups were less likely to be willing to participate in research without payment. Higher payment was associated with higher perceived study risks, while preferences for form of payment varied by age, gender, education, race-ethnicity, and census region of residence. Findings suggest payment may influence prospective research participants’ risk–benefit calculus and participation, and that a one-size-fits-all approach to payment could differentially influence participation among distinct sociodemographic groups

    Patient-reported outcomes in multiple sclerosis: a prospective registry cohort study

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    Registries have the potential to tackle some of the current limitations in determining the longterm impact of multiple sclerosis (MS). Online assessments using patient-reported outcomes (PROs) can streamline follow-up enabling large-scale, long-term, cost-effective, home-based, and patient-focused data collection. However, registry data are sparsely sampled and the sensitivity of PROs relative to clinician-reported scales is unknown, making it hard to fully leverage their unique scope and scale to derive insights. This retrospective and prospective cohort study over 11 years involved 15,976 patients with multiple sclerosis from the United Kingdom Multiples Sclerosis Register. Primary outcomes were changes in two PROs: Multiple Sclerosis Impact Scale (MSIS-29) motor component, and Multiple Sclerosis Walking Scale (MSWS-12). First, we investigated their validity in measuring the impact of physical disability in multiple sclerosis, by looking at their sensitivity to disease subtype and duration. We grouped the available records (91,351 for MSIS-29 and 68,092 for MSWS-12) by these two factors, and statistically compared the resulting groups using a novel approach based on Monte Carlo permutation analysis that was designed to cope with the intrinsic sparsity of registry data. Next, we used the PROs to draw novel insights into the developmental time course of subtypes; in particular, the period preceding the transition from relapsing to progressive forms. We report a robust main effect of disease subtype on the PROs and interactions of disease subtype with duration (all p<0.0001). Specifically, PROs worsen with disease duration for all subtypes (all p<0.0001) apart from Benign MS (MSIS-29 motor: p=0.796; MSWS-12: p=0.983). Furthermore, the PROs of each subtype are statistically different from those of the other subtypes at all time bins (MSIS-29 motor: all p<0.05; MSWS-12: all p<0.01) except when comparing Relapsing Remitting MS with Benign MS and Primary Progressive MS with Secondary Progressive MS. Notably, there were statistically significant differences between relapsing and progressive subtypes at disease onset. Critically, the PROs are sensitive to future transitions to progressive subtypes, with individuals who transition presenting with higher PROs in their relapsing phase compared to individuals who don’t transition since onset (all p<0.0001). PROs capture different patterns of physical worsening over disease length and across subtypes; therefore, they are a valid tool to measure the physical impact of multiple sclerosis over the long-term and cost-effectively. Furthermore, more advanced physical disability manifests years prior to clinical detection of progressive subtypes, adding evidence to the presence of a multiple sclerosis prodrome

    Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged Study

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    Background: Monetary incentives in research are frequently used to support participant recruitment and retention. However, there are scant empirical data regarding how researchers decide upon the type and amount of incentives offered. Likewise, there is little guidance to assist study investigators and institutional review boards (IRBs) in their decision-making on incentives. Monetary incentives, in addition to other factors such as the risk of harm or other intangible benefits, guide individuals’ decisions to enroll in research studies. These factors emphasize the need for evidence-informed guidance for study investigators and IRBs when determining the type and amount of incentives to provide to research participants. Objective: The specific aims of our research project are to (1) characterize key stakeholders’ views on and assessments of incentives in biomedical HIV research; (2) reach consensus among stakeholders on the factors that are considered when choosing research incentives, including consensus on the relative importance of such factors; and (3) pilot-test the use of the guidance developed via aims 1 and 2 by presenting stakeholders with vignettes of hypothetical research studies for which they will choose corresponding incentive types. Methods: Our 2-year study will involve monthly, active engagement with a stakeholder advisory board of people living with HIV, researchers, and IRB members. For aim 1, we will conduct a nationwide survey (N=300) among people living with HIV to understand their views regarding the incentives used in HIV research. For aim 2, we will collect qualitative data by conducting focus groups with people living with HIV (n=60) and key informant interviews with stakeholders involved in HIV research (people living with HIV, IRB members, and biomedical HIV researchers: n=36) to extend and deepen our understanding of how incentives in HIV research are perceived. These participants will also complete a conjoint analysis experiment to gain an understanding of the relative importance of key HIV research study attributes and the impact that these attributes have on study participation. The data from the nationwide survey (aim 1) will be triangulated with the qualitative and conjoint analysis data (aim 2) to create 25 vignettes that describe hypothetical HIV research studies. Finally, individuals from each stakeholder group will select the most appropriate incentive that they feel should be used in each of the 25 vignettes (aim 3). Results: The stakeholder advisory board began monthly meetings in March 2021. All study aims are expected to be completed by December 2022. Conclusions: By studying the role of incentives in HIV clinical trial participation, we will establish a decision-making paradigm to guide the choice of incentives for HIV research and, eventually, other types of similar research and facilitate the ethical recruitment of clinical research participants
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