Browsing by Subject "compliance"
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Item A PROPOSED MODEL FOR POST-APPROVAL MONITORING (PAM) OF INSTITUTIONAL BIOSAFETY PROTOCOL IN AN ACADEMIC ENVIRONMENT(2014-03) Uche, Uloma I.; Nair, MayaThe main goal of this project is to develop inspection program over research work involving biological agents and to ensure compliance with National Institute of Health guidelines. Purpose (a): Hypothesis: I hypothesize that a well-defined model for post-approval monitoring will enhance the efficiency of biosafety program. Purpose: To ensure that approved protocols are appropriately executed and any changes are reported for approval. Methods (b): Materials: Approved protocols/IBC application. Forms to conduct the post approval monitoring. A program out line or Post approval monitoring. An evaluation process or tool to validate the efficiency of the proposed model. Methods: Prior to PAM, a project protocol has to be approved by the Institutional Biosafety Committee (IBC) and the principal Investigator proceeds with the research. With the current Biosfaty program at UNTHSC, the institutional biosafety officer will conduct an annual inspection of each of these laboratories with containment level BSL2 and BSL2+. We are proposing to develop a model for PAM of Biosafety protocols. The process involve the following steps. Critically examined the existing biosafety auditing program. Research on existing biosafety auditing program in other academic institutions in Texas. Development of the proposed model for Post Approval monitoring program. Timeline and major steps involved in the proposed model are: Inspection of the laboratory and laboratory procedures of the on-going research for compliance must be done by the Biosafety officer within 2-3 weeks after the protocol approval. The crucial component of this inspection will be an on the spot education about any deficiencies identified during the inspection. After the first year of approval, a thorough review of the protocol and laboratory procedures should be conducted by an assigned member of the institutional biosafety committee. Post-visit communication to the principal investigator about any deficiency or compliance found should be recorded and communicated with the principal investigator. Any training requirement should be communicated effectively. Finally towards the end of the research, another lab procedure evaluation should be conducted. Results (c): Results: From the post-approval monitoring, there will be compliance with IBC policies/NIH guidelines and the facility and laboratory workers will be protected from hazardous materials. Conclusions (d): Conclusion: Institutional Biosafety protocol guides and ensures safety and compliance with policies. An efficient post-approval monitoring would be a tool to assist the IBC with its obligations and facilitate a successful program oversight.Item A Quality Improvement Initiative: Evaluating the Impact of Standardized Data Tracking Tools in the Radiation Oncology Clinical Research Office at the University of Texas Southwestern Medical Center(2022-05) Acevedo, Katalina V.; Mathew, Stephen O.; Ranjan, Amalendu P.Developing preventative measures through intentional planning and oversight of clinical trials has the potential to increase efficiency and quality of trial processes and data. This practicum report details a Quality Improvement (QI) initiative evaluating implementation and impact of a standardized data-tracking software on clinical research data compliance in the Radiation Oncology Clinical Research Office at UT Southwestern Medical Center (UTSW). The standardized data tracker evaluated in this study was built through Quickbase, a cloud-based, low-code application development platform specializing in project management and operations optimization. This project evaluated data sets from two active radiation oncology clinical trials using repeated cross-sectional methods to compare rates of data non-compliance and trends in the types of non-compliance exhibited at baseline, one-month, and three-month post data-tracker implementation. Trends in non-compliance were reviewed and preventative measures backed by recommendations from the literature were proposed to facilitate future QI initiatives within the department. The Chi-Squared (X2) Test for Independence was used to determine whether there was a statistical difference in rates of data non-compliance across the three timepoints within studies and overall followed by post-hoc tests consisting of pairwise comparisons with Bonferroni corrections. Overall, statistical analysis revealed a significant difference in rates on non- compliance across timepoints, suggesting that implementation of the standardized Quickbase data-tracking management tool does significantly decrease rates of non-compliance. Descriptive statistics were performed to characterize the trends in non-compliance within each study across timepoints. This quality improvement project was the first of its kind to formally examine data management trends and practices within the Radiation Oncology Clinical Research Office at UT Southwestern Medical Center. The results provide positive feedback regarding the implementation of a standardized Quickbase data-tracking management tool and characterization of non-compliant data illuminated pressure points in data management workflow that can inform future QI initiatives in shifting data management from its current reactive state to a more proactive data-driven approach. Future work should evaluate the proposed preventative measurements to provide further insight into best practices that can support continuous improvement initiatives within the department.Item A Study to Determine Improved Compliance of Biophosphonate Treatment in Subjects with Osteoporosis(2005-02-01) Enard, April T.; Gwirtz, Patricia A.; Jimenez-Williams, Cynthia; Rubin, BernardEnard, April T. A Study to Determine Improved Compliance of Bisphosphonate Treatment in Subjects with Osteoporosis. Master of Science, February 11, 2005. The ability of patients to adhere to treatment regimens is very poor and continues to impede optimal therapy of osteoporosis. The shortcomings in treating osteoporosis are: a) noncompliance and/or lack of continued persistence of therapy, b) efficacy of therapy on bone turnover marker levels and fracture prevalence, and c) tolerability of therapy to patients. Studies have shown that interventions such as education and awareness of bone mineral density promote patient usage compliance. The slightest improvement in compliance allows further understanding of accurate efficacy of medication therapy to fractures, bone marker levels, and overall improvement of bone mass. Increased compliance/persistence allows accurate comparison of bisphosphonates to one another for effectiveness on osteoporosis patients and allows improvement opportunity in treatment modalities that can positively influence the course of osteoporosis. This phase IV study targets compliancy/persistence in bisphosphonate therapy in treatment of osteoporosis.Item Analysis of Patient Practices and Attitudes towards Compliance with Contact Lens Storage Cases in Relation to Microbial Contamination Levels(2015-12-01) Ndedi, Sarah B.; Patricia A. Gwirtz; Arthur J. EisenbergPurpose: Non-compliant practices amongst contact lens wearers contribute to a high incidence of ocular complications and infections. During a contact lens-related adverse event, the infectious agent is almost always recovered from the contact lens storage case. This study measured the level of actual compliance with lens storage case hygiene, characterized the attitudes of contact lens wearers in regards to lens storage case hygiene, and correlated these factors with microbial contamination of the contact lens storage case. Since compliance is based upon patients’ adherence to physicians’ recommendations, this study also surveyed eye care practitioners about their knowledge of contact lens case care to identify areas of education that need to be addressed within both the practitioner and lens wearer populations. Hypotheses: 1) Certain personality traits and negative attitudes toward compliance with contact lens wear and care may be indicative of non-compliant hygiene practices and, in turn, result in higher levels of contact lens storage case contamination. 2) Recommendations by eye care practitioners regarding contact lens storage case care may be inadequate and may contribute to inappropriate care practices and low compliance rates amongst lens wearers. Methods: In the first arm of this study, a contact lens storage case drive was conducted at the University of Texas Southwestern Medical Center. During the contact lens storage case drive, participants completed anonymous, self-administered questionnaires, and submitted their used contact lens cases for analysis. Collected surveys served to characterize patient attitudes towards proper lens storage case hygiene and calculate compliance scores based on patient reported practices. The cases were then analyzed using a crystal violet assay to stain and quantify the level of biofilm (matrix of microorganisms) present within the wells. In the second arm of the study, 616 eye care practitioners were invited to complete a survey regarding their recommendations for proper lens storage case hygiene. Data summarizing the overall results of each set of surveys were compiled and statistical analyses were conducted to determine trends and correlations between variables. Results: In the patient group, 90% of individuals were deemed as having positive attitudes (score of 1 and above). The average attitude score was 10 ± 6.7 with a range of -7 to 26. Average compliance was 64% ± 20% with a range of 4-100%. Approximately 57% of subjects displayed poor compliance (≤69%), 35% average compliance (70-89%), 7% had good compliance (≥90%), and 1.5% had full compliance (100%). No significant relationship was found between the subjects’ attitude scores and compliance grades (p=0.516). The average absorbance from the crystal violet assays, used to quantify the level of biofilm, was 1.9 ± 6.5 with a range of 0.0093 to 64.1. No significant relationship was found between compliance grades and absorbance values (p=0.794). Additionally, no significant relationship was found between attitudes and absorbance (p=0.689). Certain patient attitudes and improper contact lens storage case hygiene practices reflected the reported recommendations of practitioners. Conclusions: Education about the importance of contact lens case replacement and cleaning is needed for both eye care practitioners and patients alike. Both of these educational goals could reduce the risks of infections in the contact lens wearing population.Item Beta Testing and the Population Genetics of Promega's Prototype PowerPlex Y Kit(2004-08-01) Kirkendoll, Ross A.; Joseph Warren; John Planz; Arthur EisenbergDevelopmental validation is typically done by the manufacturer of the technique or technology. According to National Standards, the manufacturer must test for human specificity to ensure compliance with standards. In addition, the PowerPlex Y kit must be shown to have male specificity because all of the loci are located on the Y-chromosome. Other necessary studies include mixture both male/female and male/male mixture studies, stability studies to show stability in the presence of environmental insults, and the focus of this study the construction of a popular database. In order to satisfy both the requirement of the National Standards and the scrutiny of the legal system, Promega Corporation assembled a collaboration of different laboratories to assist with the developmental validation of the PowerPlex Y Kit. This project was a small part of that collaboration. The DNA Identify Laboratory was chosen by Promega to assist with the construction of a population database because of the number of samples available and the need for confirmed father/son pairs. The objectives of the study were to type ~200 father/son pairs from each of the Caucasian and African American races, and then determine the haplotype frequencies, haplotype diversities, and mutation rates for each race.