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Harm during hospitalizations for heart failure: adverse events as a reliability measure of hospital policies and procedures

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For more than twenty years, clinical researchers have been publishing data regarding incidence and risk of adverse events (AEs) incurred during hospitalizations. Hospitals have standard operating policies and procedures (SOPP) to protect patients from AE. The AE specifics (rates, SOPP failures, timing and risk factors) during heart failure (HF) hospitalizations…

For more than twenty years, clinical researchers have been publishing data regarding incidence and risk of adverse events (AEs) incurred during hospitalizations. Hospitals have standard operating policies and procedures (SOPP) to protect patients from AE. The AE specifics (rates, SOPP failures, timing and risk factors) during heart failure (HF) hospitalizations are unknown. There were 1,722 patients discharged with a primary diagnosis of HF from an academic hospital between January 2005 and December 2007. Three hundred eighty-one patients experienced 566 AEs, classified into four categories: medication (43.9%), infection (18.9%), patient care (26.3%), or procedural (10.9%). Three distinct analyses were performed: 1) patient's perspective of SOPP reliability including cumulative distribution and hazard functions of time to AEs; 2) Cox proportional hazards model to determine independent patient-specific risk factors for AEs; and 3) hospital administration's perspective of SOPP reliability through three years of the study including cumulative distribution and hazard functions of time between AEs and moving range statistical process control (SPC) charts for days between failures of each type. This is the first study, to our knowledge, to consider reliability of SOPP from both the patient's and hospital administration's perspective. AE rates in hospitalized patients are similar to other recently published reports and did not improve during the study period. Operations research methodologies will be necessary to improve reliability of care delivered to hospitalized patients.
ContributorsHuddleston, Jeanne (Author) / Fowler, John (Thesis advisor) / Montgomery, Douglas C. (Thesis advisor) / Gel, Esma (Committee member) / Shunk, Dan (Committee member) / Arizona State University (Publisher)
Created2012
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The development of a validated clinically meaningful endpoint for the evaluation of tear film stability as a measure of ocular surface protection for use in the diagnosis and evaluation of dry eye disease

Description
This dissertation presents methods for the evaluation of ocular surface protection during natural blink function. The evaluation of ocular surface protection is especially important in the diagnosis of dry eye and the evaluation of dry eye severity in clinical trials. Dry eye is a highly prevalent disease affecting vast numbers…

This dissertation presents methods for the evaluation of ocular surface protection during natural blink function. The evaluation of ocular surface protection is especially important in the diagnosis of dry eye and the evaluation of dry eye severity in clinical trials. Dry eye is a highly prevalent disease affecting vast numbers (between 11% and 22%) of an aging population. There is only one approved therapy with limited efficacy, which results in a huge unmet need. The reason so few drugs have reached approval is a lack of a recognized therapeutic pathway with reproducible endpoints. While the interplay between blink function and ocular surface protection has long been recognized, all currently used evaluation techniques have addressed blink function in isolation from tear film stability, the gold standard of which is Tear Film Break-Up Time (TFBUT). In the first part of this research a manual technique of calculating ocular surface protection during natural blink function through the use of video analysis is developed and evaluated for it's ability to differentiate between dry eye and normal subjects, the results are compared with that of TFBUT. In the second part of this research the technique is improved in precision and automated through the use of video analysis algorithms. This software, called the OPI 2.0 System, is evaluated for accuracy and precision, and comparisons are made between the OPI 2.0 System and other currently recognized dry eye diagnostic techniques (e.g. TFBUT). In the third part of this research the OPI 2.0 System is deployed for use in the evaluation of subjects before, immediately after and 30 minutes after exposure to a controlled adverse environment (CAE), once again the results are compared and contrasted against commonly used dry eye endpoints. The results demonstrate that the evaluation of ocular surface protection using the OPI 2.0 System offers superior accuracy to the current standard, TFBUT.
ContributorsAbelson, Richard (Author) / Montgomery, Douglas C. (Thesis advisor) / Borror, Connie (Committee member) / Shunk, Dan (Committee member) / Pan, Rong (Committee member) / Arizona State University (Publisher)
Created2012