Browsing by Subject "Clinical Trials as Topic"

Now showing 1 - 8 of 8
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    Adolescent decision making about participation in a hypothetical HIV vaccine trial
    (Elsevier, 2015-03-10) Alexander, Andreia B.; Ott, Mary A.; Lally, Michelle A.; Sniecinski, Kevin; Baker, Alyne; Zimet, Gregory D.; Department of Pediatrics, IU School of Medicine
    Purpose The purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences. Methods As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16–19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized. Results Twelve concepts related to adolescents' decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate. Conclusion The results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation.
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    Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia
    (Ferrata Storti Foundation, 2015-01) Niemeyer, Charlotte M.; Loh, Mignon L.; Cseh, Annamaria; Cooper, Todd; Dvorak, Christopher C.; Chan, Rebecca; Xicoy, Blanca; Germing, Ulrich; Kojima, Seiji; Manabe, Atsushi; Dworzak, Michael; De Moerloose, Barbara; Starý, Jan; Smith, Owen P.; Masetti, Riccardo; Catala, Albert; Bergstraesser, Eva; Ussowicz, Marek; Fabri, Oskana; Baruchel, André; Cavé, Hélène; Zwaan, Michel; Locatelli, Franco; Hasle, Henrik; van den Heuvel-Eibrink, Marry M.; Flotho, Christian; Yoshimi, Ayami; Department of Pediatrics, IU School of Medicine
    Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.
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    Development of a Research Agenda for the Management of Metastatic Colorectal Cancer: Proceedings from a Multidisciplinary Research Consensus Panel
    (Elsevier, 2012-02) d’Othée, Bertrand Janne; Sofocleous, Constantinos T.; Hanna, Nader; Lewandowski, Robert J.; Soulen, Michael C.; Vauthey, Jean-Nicolas; Cohen, Steven J.; Venook, Alan P.; Johnson, Matthew S.; Kennedy, Andrew S.; Murthy, Ravi; Geschwind, Jean-Francois; Kee, Stephen T.; Department of Radiology and Imaging Sciences, IU School of Medicine
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    Exploring the Relationships Among Social Support, Patient Activation, and Pain-Related Outcomes
    (Oxford Academic, 2022-04) Matthias, Marianne S.; Hirsh, Adam T.; Ofner, Susan; Daggy, Joanne; Medicine, School of Medicine
    Objective Social support has been linked to more effective pain adaptation. The relationship between social support and other relevant constructs is less well understood. Chief among these is patient activation, which has robust links to effective self-management, yet has not been well studied in chronic pain. We sought to better understand these relationships in an effort to inform future intervention strategies for patients with chronic pain. Methods Using baseline data from a clinical trial with patients with chronic pain (N = 213), we analyzed the relationships among perceived social support and patient activation, depression, anxiety, general health perceptions, pain centrality, pain catastrophizing, and pain intensity and interference. Multiple linear regression was used to examine the effect of social support on outcomes. Patient activation was explored as a mediator of the effect of social support on outcomes. Results Social support was significantly associated with all outcomes except pain. Social support explained the greatest variance in patient activation (squared semi-partial correlation = 0.081), followed by depression (0.073) and general health perceptions (0.072). Patient activation was not found to be a significant mediator of the effect of social support on pain-related outcomes. Conclusions These findings provide insight into the roles of patient activation and social support in chronic pain management. Although patient activation did not mediate the relationship between social support and outcomes, this study is an important step toward gaining a more complete understanding of constructs thought to be related to pain self-management and points to the need to advance theory in this area to guide future research. Such work is needed to optimize interventions for patients with chronic pain.
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    The impact of COVID-19 pandemic on vascular registries and clinical trials
    (Elsevier, 2021-06) Aziz, Faisal; Behrendt, Christian-Alexander; Sullivan, Kaity; Beck, Adam W.; Beiles, C. Barry; Boyle, Jon R.; Mani, Kevin; Benson, Ruth A.; Wohlauer, Max V.; Khashram, Manar; Jorgensen, Jens Eldrup; Lemmon, Gary W.; Surgery, School of Medicine
    Quality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.
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    Impact of the Alzheimer's Disease Neuroimaging Initiative, 2004 to 2014
    (Elsevier, 2015-07) Weiner, Michael W.; Veitch, Dallas P.; Aisen, Paul S.; Beckett, Laurel A.; Cairns, Nigel J.; Cedarbaum, Jesse; Donohue, Michael C.; Green, Robert C.; Harvey, Danielle; Jack, Clifford R.; Jagust, William; Morris, John C.; Petersen, Ronald C.; Saykin, Andrew J.; Shaw, Leslie; Thompson, Paul M.; Toga, Arthur W.; Trojanowski, John Q.; Alzheimer's Disease Neuroimaging Initiative; Department of Radiology and Imaging Sciences, IU School of Medicine
    INTRODUCTION: The Alzheimer's Disease Neuroimaging Initiative (ADNI) was established in 2004 to facilitate the development of effective treatments for Alzheimer's disease (AD) by validating biomarkers for AD clinical trials. METHODS: We searched for ADNI publications using established methods. RESULTS: ADNI has (1) developed standardized biomarkers for use in clinical trial subject selection and as surrogate outcome measures; (2) standardized protocols for use across multiple centers; (3) initiated worldwide ADNI; (4) inspired initiatives investigating traumatic brain injury and post-traumatic stress disorder in military populations, and depression, respectively, as an AD risk factor; (5) acted as a data-sharing model; (6) generated data used in over 600 publications, leading to the identification of novel AD risk alleles, and an understanding of the relationship between biomarkers and AD progression; and (7) inspired other public-private partnerships developing biomarkers for Parkinson's disease and multiple sclerosis. DISCUSSION: ADNI has made myriad impacts in its first decade. A competitive renewal of the project in 2015 would see the use of newly developed tau imaging ligands, and the continued development of recruitment strategies and outcome measures for clinical trials.
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    Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration
    (Oxford University Press, 2015-07) Bossuyt, V.; Provenzano, E.; Symmans, W. F.; Boughey, J. C.; Coles, C.; Curigliano, G.; Dixon, J. M.; Esserman, L. J.; Fastner, G.; Kuehn, T.; Peintinger, F.; von Minckwitz, G.; White, J.; Yang, W.; Badve, Sunil; Denkert, C.; MacGrogan, G.; Penault-Llorca, F.; Viale, G.; Cameron, D.; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration; Department of Pathology and Laboratory Medicine, IU School of Medicine
    Neoadjuvant systemic therapy (NAST) provides the unique opportunity to assess response to treatment after months rather than years of follow-up. However, significant variability exists in methods of pathologic assessment of response to NAST, and thus its interpretation for subsequent clinical decisions. Our international multidisciplinary working group was convened by the Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration and tasked to recommend practical methods for standardized evaluation of the post-NAST surgical breast cancer specimen for clinical trials that promote accurate and reliable designation of pathologic complete response (pCR) and meaningful characterization of residual disease. Recommendations include multidisciplinary communication; clinical marking of the tumor site (clips); and radiologic, photographic, or pictorial imaging of the sliced specimen, to map the tissue sections and reconcile macroscopic and microscopic findings. The information required to define pCR (ypT0/is ypN0 or ypT0 yp N0), residual ypT and ypN stage using the current AJCC/UICC system, and the Residual Cancer Burden system were recommended for quantification of residual disease in clinical trials.
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    A semiparametric recurrent events model with time-varying coefficients
    (Wiley Blackwell (John Wiley & Sons), 2013-03-15) Yu, Zhangsheng; Liu, Lei; Bravata, Dawn M.; Williams, Linda S.; Tepper, Robert S.; Department of Biostatistics, Richard M. Fairbanks School of Public Health
    We consider a recurrent events model with time-varying coefficients motivated by two clinical applications. We use a random effects (Gaussian frailty) model to describe the intensity of recurrent events. The model can accommodate both time-varying and time-constant coefficients. We use the penalized spline method to estimate the time-varying coefficients. We use Laplace approximation to evaluate the penalized likelihood without a closed form. We estimate the smoothing parameters in a similar way to variance components. We conduct simulations to evaluate the performance of the estimates for both time-varying and time-independent coefficients. We apply this method to analyze two data sets: a stroke study and a child wheeze study.