Browsing by Subject "clinical research"

Now showing 1 - 8 of 8
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    Clinical performance of intentionally tilted implants versus axially positioned implants: A systematic review
    (Wiley, 2018-10) Lin, Wei-Shao; Eckert, Steven E.; Prosthodontics, School of Dentistry
    Objectives The aim of this review was to determine the clinical performance of dental implants that are intentionally tilted when compared with implants that are placed following the long axis of the residual alveolar ridge. Materials and methods A systematic review of the scientific literature using a predefined research question (PICO) and search strategy was undertaken. This search included five electronic databases. Two independent reviewers examined electronic databases and performed a manual review following search strategy to accomplish the item generation and reduction. Included articles were evaluated to determine the level of evidence. Data were extracted only from level I and level II studies, based on the Oxford Centre for Evidence‐based Medicine—Levels of Evidence (March 2009). If included studies were homogeneous in nature, data were to be accumulated. However, if included studies were heterogeneous in nature, only descriptive data would be reviewed and analyzed. Results A total of 811 articles were identified through the PICO question and search strategy. Detailed review of the abstracts and articles resulted in further item reduction, and 46 articles were included for full‐text review. A total of 42 articles were then selected for inclusion in the systematic review. The identified articles included two level I and 20 level II studies. In addition, 15 level IV, one gray literature, and four previous systematic reviews with meta‐analyses were also used in the study. The extracted data from the included studies demonstrated heterogeneity that prevented quantitative assessment, and only one level II study directly compared tilted and axially placed implants. Assessment of the descriptive data demonstrated no differences in implant survival, marginal bone loss, prosthesis survival, or patient‐reported outcome measures (PROMs) whether implants are placed axially or with intentional inclination of the coronal aspect of the implant toward the distal aspect of edentulous jaws. Conclusions Based upon the systematic review of the literature, an analysis of the descriptive data suggested no differences in clinical performance between implants that are placed in an axial position relative to the residual alveolar ridge when compared with implants that are intentionally tilted toward the distal aspect of edentulous jaws.
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    Developing Common Metrics for the Clinical and Translational Science Awards (CTSAs): Lessons Learned.
    (Wiley, 2015-10) Rubio, Doris M.; Blank, Arthur E.; Dozier, Ann; Hites, Lisle; Gilliam, Victoria A.; Hunt, Joe; Rainwater, Julie; Trochim, William M.; Indiana CTSI
    The National Institutes of Health (NIH) Roadmap for Medical Research initiative, funded by the NIH Common Fund and offered through the Clinical and Translational Science Award (CTSA) program, developed more than 60 unique models for achieving the NIH goal of accelerating discoveries toward better public health. The variety of these models enabled participating academic centers to experiment with different approaches to fit their research environment.A central challenge related to the diversity of approaches is the ability to determine the success and contribution of each model. This paper describes the effort by the Evaluation Key Function Committee to develop and test a methodology for identifying a set of common metrics to assess the efficiency of clinical research processes and for pilot testing these processes for collecting and analyzing metrics. The project involved more than one-fourth of all CTSAs and resulted in useful information regarding the challenges in developing common metrics, the complexity and costs of acquiring data for the metrics, and limitations on the utility of the metrics in assessing clinical research performance. The results of this process led to the identification of lessons learned and recommendations for development and use of common metrics to evaluate the CTSA effort.
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    Effect of Glucose–Insulin–Potassium Infusion on Mortality in Critical Care Settings: A Systematic Review and Meta-Analysis
    (2009-07) Puskarich, Michael A; Runyon, Michael S; Trzeciak, Stephen; Kline, Jeffrey A.; Jones, Alan E
    This study seeks to measure the treatment effect of glucose—insulin—potassium (GIK) infusion on mortality in critically ill patients. A systematic review of randomized controlled trials is conducted, comparing GIK treatment with standard care or placebo in critically ill adult patients. The primary outcome variable is mortality. Two authors independently extract data and assess study quality. The primary analysis is based on the random effects model to produce pooled odds ratios (ORs) with 95% confidence intervals (CIs). The search yields 1720 potential publications; 23 studies are included in the final analysis, providing a sample of 22 525 patients. The combined results demonstrate no heterogeneity (P = .57, I2 = 0%) and no effect on mortality (OR = 1.02; 95% CI, 0.93–1.11) with GIK treatment. No experimental studies of shock or sepsis populations are identified. This meta-analysis finds that there is no mortality benefit to GIK infusion in critically ill patients; however, study populations are limited to acute myocardial infarction and cardiovascular surgery patients. No studies are identified using GIK in patients with septic shock or other forms of circulatory shock, providing an absence of evidence regarding the effect of GIK as a therapy in patients with shock.
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    Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience
    (Wiley, 2018) Cheng, Yao-Wen; Phelps, Emmalee; Ganapini, Vincent; Khan, Noor; Ouyang, Fangqian; Xu, Huiping; Khanna, Sahil; Tariq, Raseen; Friedman-Moraco, Rachel J.; Woodworth, Michael H.; Dhere, Tanvi; Kraft, Colleen S.; Kao, Dina; Smith, Justin; Le, Lien; El-Nachef, Najwa; Kaur, Nirmal; Kowsika, Sree; Ehrlich, Adam; Smith, Michael; Safdar, Nasia; Misch, Elizabeth Ann; Allegretti, Jessica R.; Flynn, Ann; Kassam, Zain; Sharfuddin, Asif; Vuppalanchi, Raj; Fischer, Monika; Medicine, School of Medicine
    Fecal microbiota transplant (FMT) is recommended for Clostridium difficile infection (CDI) treatment; however, use in solid organ transplantation (SOT) patients has theoretical safety concerns. This multicenter, retrospective study evaluated FMT safety, effectiveness, and risk factors for failure in SOT patients. Primary cure and overall cure were defined as resolution of diarrhea or negative C difficile stool test after a single FMT or after subsequent FMT(s) ± anti‐CDI antibiotics, respectively. Ninety‐four SOT patients underwent FMT, 78% for recurrent CDI and 22% for severe or fulminant CDI. FMT‐related adverse events (AE) occurred in 22.3% of cases, mainly comprising self‐limiting conditions including nausea, abdominal pain, and FMT‐related diarrhea. Severe AEs occurred in 3.2% of cases, with no FMT‐related bacteremia. After FMT, 25% of patients with underlying inflammatory bowel disease had worsening disease activity, while 14% of cytomegalovirus‐seropositive patients had reactivation. At 3 months, primary cure was 58.7%, while overall cure was 91.3%. Predictors of failing a single FMT included inpatient status, severe and fulminant CDI, presence of pseudomembranous colitis, and use of non‐CDI antibiotics at the time of FMT. These data suggest FMT is safe in SOT patients. However, repeated FMT(s) or additional antibiotics may be needed to optimize rates of cure with FMT.
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    How the clinical research community responded to the COVID-19 pandemic: an analysis of the COVID-19 clinical studies in ClinicalTrials.gov
    (AMIA, 2021-04-01) He, Zhe; Erdengasileng, Arslan; Luo, Xiao; Xing, Aiwen; Charness, Neil; Bian, Jiang; Computer Information and Graphics Technology, School of Engineering and Technology
    In the past few months, a large number of clinical studies on the novel coronavirus disease (COVID-19) have been initiated worldwide to find effective therapeutics, vaccines, and preventive strategies for COVID-19. In this study, we aim to understand the landscape of COVID-19 clinical research and identify the issues that may cause recruitment difficulty or reduce study generalizability.We analyzed 3765 COVID-19 studies registered in the largest public registry—ClinicalTrials.gov, leveraging natural language processing (NLP) and using descriptive, association, and clustering analyses. We first characterized COVID-19 studies by study features such as phase and tested intervention. We then took a deep dive and analyzed their eligibility criteria to understand whether these studies: (1) considered the reported underlying health conditions that may lead to severe illnesses, and (2) excluded older adults, either explicitly or implicitly, which may reduce the generalizability of these studies to the older adults population.Our analysis included 2295 interventional studies and 1470 observational studies. Most trials did not explicitly exclude older adults with common chronic conditions. However, known risk factors such as diabetes and hypertension were considered by less than 5% of trials based on their trial description. Pregnant women were excluded by 34.9% of the studies.Most COVID-19 clinical studies included both genders and older adults. However, risk factors such as diabetes, hypertension, and pregnancy were under-represented, likely skewing the population that was sampled. A careful examination of existing COVID-19 studies can inform future COVID-19 trial design towards balanced internal validity and generalizability.
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    Integrating the International Classification of Functioning, Disability, and Health Model into Massage Therapy Research, Education, and Practice
    (2010-12) Munk, Niki; Harrison, Anne
    Without an increase in clearly defined and clinically significant outcomes research in massage therapy (MT), the practice is in jeopardy of remaining on the fringes of accepted and utilized therapeutic care. This reality will slow the integration of MT into routine preventive, rehabilitative, curative, and supportive care. The International Classification of Functioning, Disability, and Health (ICF) developed by the World Health Organization is a comprehensive model of functioning and disability that provides a universal taxonomy of human functioning that is recognized globally. Integration of the ICF model into MT research, education, and practice would provide a foundation for a common language, particularly in regard to examining outcomes of MT. Here, we review the dynamic and respected ICF model as it applies to massage research, outcomes dissemination, education, and practice, with these specific objectives: To describe the specific domains of the ICF model To apply the described ICF domains to current massage practice and research To discuss how integration of the ICF model enhances communication and translation among those within and to those outside the MT field The ICF model is ideal for application to MT interests because it works outside the typical focus on pathology or a specific organ system. Instead, the ICF focuses on impairment or limitations in functioning associated with health conditions. The ICF also highlights and incorporates the complex interactions of environment and personal factors and the impact that those factors exert on the domains of body structure, activity, and participation. This interaction has unique implications for MT practitioners, researchers, and clients/patients. Furthermore, the ICF model provides a framework for classifying outcomes, which is a critical aspect of clinical research.
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    It Worked There, So It Should Work Here: Sustaining Change while Improving Product Development Processes
    (Wiley, 2019-04) Collins, Shawn T.; Browning, Tyson R.; Technology and Leadership Communication, School of Engineering and Technology
    Organizations operate under ongoing pressure to conduct product development (PD) in ways that reduce errors, improve product designs, and increase speed and efficiency. Often, managers are expected to respond to this pressure by implementing process improvement programs (PIPs) based on best practices elsewhere (e.g., in another part of their organization or in another industrial context). Successful PIP implementation depends on two criteria: (a) demonstrating (symbolic) success by meeting externally imposed deadlines and producing mandated artifacts and (b) sustaining the expected (substantive) changes in their employees' underlying beliefs and practices. Given the mixed success of PIPs in nonmanufacturing contexts, identifying factors that contribute to both symbolic and substantive implementation is important to both researchers and practitioners. We explore this challenge through an in‐depth field study at a PD company (DevCo) that implemented a PIP across its 11 PD projects. We examine DevCo's change message to implement the PIP, how DevCo's engineers experienced it, factors that impeded implementation, and factors that could improve substantive success. Along with this empirical evidence, we leverage organizational change concepts to facilitate effective PIP implementation in new contexts such as PD. We distill our findings into eight propositions that expand theory about effectively transferring PIPs across contexts.
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    Metastatic Pancreatic Adenocarcinoma After Total Pancreatectomy Islet Autotransplantation for Chronic Pancreatitis
    (Wiley, 2016-09) Muratore, S.; Zeng, X.; Korc, M.; McElyea, S.; Wilhelm, J.; Bellin, M.; Beilman, G.; Medicine, School of Medicine
    Total pancreatectomy with islet autotransplantation (TPIAT) is being used increasingly as a definitive treatment for chronic pancreatitis. Patients with chronic pancreatitis have an elevated risk of pancreatic cancer, which can also masquerade as acute or chronic pancreatitis, making the diagnosis challenging. We describe here the first case of pancreatic ductal adenocarcinoma developing in the liver of a patient after TPIAT for presumed benign chronic pancreatitis. Retrospective analysis of the patient’s preoperative serum revealed normal carbohydrate antigen 19-9 and carcinoembryonic antigen levels but elevated levels of microRNAs -10b, -30c, and -106b compared with controls. Screening guidelines are important to reduce the risk of transplantation of malignant tissue. More sensitive screening tools, including the potential use of microRNAs, are needed to detect early preclinical disease, given the highly malignant nature of pancreatic cancer.