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Hepatic and renal impairment trials: FDA guidance and industry practiceHeller, Gillis L. January 2006 (has links)
published_or_final_version / abstract / Community Medicine / Master / Master of Public Health
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Utility of cardiac biomarkers in end-stage renal disease patients on maintenance peritoneal dialysisWang, Yee-moon, Angela., 王依滿. January 2008 (has links)
published_or_final_version / Medicine / Doctoral / Doctor of Philosophy
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Heart failure in elderly with focus on diagnosis and prognosisOlofsson, Mona January 2015 (has links)
Background: Patients older than 75 years with heart failure (HF) are at increased risk for mortality and hospital admissions. Echocardiography and brain natriuretic peptides (BNP, NTproBNP) are important diagnostic tools but sparsely evaluated in elderly PHC patients. Aims: Validate the clinical diagnosis of HF, investigate the types of HF and underlying cardiovascular disorders with focus on sex and age differences. Explore the sensitivity, specificity, negative and positive predictive values (NPV, PPV) of BNP and NT-proBNP in patients with systolic HF. Study the associations of HF or NTproBNP on all-cause and cardiovascular mortality. Study the prognostic value of different biomarkers and HF, on all-cause and cardiovascular hospitalizations. Methods: Patients with suspected HF were recruited from one selected PHC and registered on a prespecified record and referred for an echocardiographic examination and a final cardiologist consultation. Blood samples for natriuretic peptides were stored frozen at – 70° C. Death certificates were used to register all-cause mortality and cardiovascular mortality. To register hospitalisations, medical records were used and classification was defined according to ICD-10. Results The GPs identified 121 women and 49 men with suspected HF of whom 39% (51 women and 16 men) were above 80 years. Myocardial infarction (OR:4,3 CL: 1,8-10,6) hypertension (OR:3,4 CI:1,6-6,9) atrial fibrillation (OR:2,8 CL:1,0-7,9) predicted a confirmed diagnosis of HF. Confirmed HF was verified in 45% of the patients and was significantly more common in men than women (p=0,02). The best NPV was 88 % for NT-proBNP (200 ng/L) and 87 % for BNP (20 pg/ml). Age and male gender were independently associated with higher levels of NT-proBNP. During the 10-year follow up, 71 out of 144 patients died. In univariate Cox regression analysis, significant associations were found for overall HF (hazard ratio [HR]: 1.86; 95% confidence interval [CI]:1.15- 3.01), isolated systolic HF (HR:1.95; 95% CI:1.06-3.61), and combined (systolic and diastolic) HF (HR:3.28; 95% CI:1.74-6.14) with all-cause mortality, but not for isolated diastolic HF. In multivariable analysis, age (HR: 1.11; 95% CI: 1.06-1.17), kidney dysfunction (HR:1.91; 95% CI:1.11- 3.29), smoking (HR:3.70; 95% CI:2.02-6.77), and NTproBNP (HR:1.01; 95% CI:1.00-1.02), but not any type of HF, significantly predicted all-cause mortality. During ten years, 136 (80%) patients were hospitalised with 660 and 207 for all-cause and cardiovascular hospitalisations, respectively. Age (OR:1.1; 95% CI:1.01-1.15) and underlying heart disease (OR:3.5; 95% CI:1.00-11.89), significantly predicted all-cause hospitalisation. Overall HF (HR:1.8; 95% CI:1.06-2.94) significantly predicted time to first all-cause hospitalisations. For cardiovascular hospitalisations age (OR:1.1;95%CI:1.01-1.12), underlying heart disease (OR:3.4;95%CI:1.04-11.40) and NTproBNP ≥800 ng/L (OR:4,3;95%CI:1.5-12.50) were significant predictors. Conclusion: A confirmed diagnosis of HF was present in 45% of the patients. NPV was high, but not as high as in younger patients with HF. Patients with systolic HF had a higher mortality than patients with diastolic HF compared to patients with no HF. Patients with combined HF were at even higher risk for all-cause mortality and cardiovascular mortality. Age, kidney dysfunction, NTproBNP and smoking predicted mortality. Age and underlying heart diseases were predictors for all-cause hospitalisations and together with NTproBNP they also predicted cardiovascular hospitalisations.
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AN EMPIRICAL ANALYSIS OF THE UTILIZATION PATTERNS OF WITHIN FACILITY AND SECONDARY HEALTHCARE SERVICES BY KENTUCKY STATE PRISON INMATESWinter, Sandra Jane 01 January 2009 (has links)
The inmate population is increasing, aging and generally in poorer health than the non-incarcerated population. Providing healthcare to inmates is constitutionally mandated, and expensive. Little published research exists to assist corrections health policy makers strategically plan for future inmate healthcare needs. This research provides an extensive description of the healthcare utilization patterns of a sample of 577 male and female inmates incarcerated at state-operated prisons in Kentucky during the period January 1, 2007, to December 31, 2007 and who have at least one of the chronic conditions of diabetes, hypertension or hyperlipidemia. The primary outcome measures were a count of the number of encounters documented in the inmate‟s electronic health record by 1) medical doctors and advanced registered nurse practitioners (medical care utilization) and 2) psychiatrists and psychologists (mental healthcare utilization), and 3) a dichotomous variable indicating if the inmate had received care from a health provider located outside the prison. The explanatory variables included demographic variables, health status variables, health risk factors, sentence-related variables, facility characteristics, inmate to corrections and medical staff ratios and quality of care indicators. Differences in healthcare utilization between various groups of inmates were tested using Pearson‟s chi-squared test for categorical variables and Student t-test for continuous variables. In the bivariate analysis increasing age, being female, having comorbidities, having a diagnosis of mental illness, being obese, not adhering to diet, exercise and medications, refusing or missing treatment, being at a facility with more corrections or medical staff and having better quality of care were all associated with greater healthcare utilization. Negative binomial regression was used to analyze the count outcomes, and multivariate logistic regression analysis was used to analyze the dichotomous outcome. Regression analysis revealed that the number of problems an inmate had recorded in their electronic health record and increasing age were the two greatest predictors of within facility and secondary healthcare utilization. Carrying out case management and disease management for inmates with comorbidities may have benefits for Departments of Corrections and inmates.
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ESSAYS ON THE PERSISTENCE OF POVERTYIslam, T M Tonmoy 01 January 2012 (has links)
My dissertation investigates the reasons behind the persistence of income among individuals and US counties. I look at the role of initial conditions in explaining current level of income. In my first essay, I look at how childhood neighborhood conditions affect income of a person. To study persistence, I model income as an autoregressive process where the coefficient on the lagged dependent variable heterogeneous across individuals. In my second essay, I derive a new way to measure chronic poverty, or long term poverty. Current measures of chronic poverty cannot be used to compare improvements of poverty rates over time. Using my measure, one can compare to see if chronic poverty rates changed over time. My third essay looks at the historical reasons behind differences in income between rich and poor counties in the US. There are about 250 counties in the US where poverty rates have been above 20 percent for the last 40 years. I look at whether current and past factors, or differences in technologies is the main reason behind persistence of high rates of poverty in these counties.
Overall, I find that childhood neighborhood conditions have a big effect in determining the coefficient on the lagged dependent variable, that is, childhood neighborhood conditions affect persistence of income. I find that improving neighborhood poverty rates by one percentage point and father’s education by one year bring the greatest improvement of social welfare. In my second essay, I show the importance of measuring chronic poverty separately from total poverty; for example, between 2000 and 2005, total poverty declined, but chronic poverty rates actually increased, which shows that the long-term poor got worse off during that time period. In my last essay, I find that some US counties remained poor mainly because of differences in factor endowment, and past and present levels of human capital explain most of the differences in current level of income between poor and non-poor counties. Differences in factor endowments explained 80 percent of income between poor and non-poor counties, while technology accounted for only 20 percent of the difference.
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Screening, Targeting, Tailoring, and Implementation in Primary Health Care : An integrated physical therapy and behavioural medicine approach to persons with persistent musculoskeletal painSandborgh, Maria January 2008 (has links)
<p>This thesis deals with a behavioural medicine approach to the management of patients with persistent musculoskeletal pain in primary health care physical therapy. The main aims of the thesis were; to develop, and evaluate the psychometric properties of, a screening instrument for risk of disability and; to evaluate the implementation and effects of a targeted and tailored treatment. </p><p>The studies comprise four samples of patients with musculoskeletal pain exceeding one month. All subjects were recruited when consulting physical therapists in Swedish primary health care settings. For development and evaluation of the Pain Belief Screening Instrument (PBSI) four samples were used; two samples (n<sub>1</sub> = 215 and n<sub>2</sub> = 93) in Study I, one sample (n = 168) in Study II, and one sample (n = 45) in Study III. For evaluation of implementation and effects of targeted and tailored treatment the 32 patients who completed treatment in Study III were used. In Study IV treatment documents of 18 patient cases from Study III were studied to evaluate treatment integrity. </p><p>The concurrent and predictive validity of the PBSI was good, and the instrument was therefore used to define subgroups with either a high or low risk for disability. A low treatment dosage of a tailored treatment for low risk patients was tried and found equally efficient as a longer treatment focusing physical exercise. Subjects who received a treatment tailored to individual patient characteristics perceived a better global outcome of treatment compared to subjects in the control group. However, no between-group differences in the disability measures were found. The evaluation of treatment integrity displayed low therapist adherence to the treatment rationale for the tailored treatment. </p><p>The studies demonstrate ways to systematically integrate a behavioural medicine approach and physical therapy. The results indicate efficiency in managing patients with persistent musculoskeletal pain in primary health care.</p>
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Obesity : a historical account of the construction of a modern epidemicFletcher, Isabel January 2012 (has links)
This thesis describes the development of the idea of an 'obesity epidemic' that figures prominently in contemporary public health discourse. It uses conceptual approaches from Science and Technology Studies and the history of medicine to analyse changing ideas about obesity, particularly as formulated and mobilised by British researchers from the 1960s onwards, to show how excess body weight became understood as a significant public health problem in this period. The thesis begins by describing the post-war refocusing of medical attention in developed countries from infectious diseases, the rates of which are falling, to chronic disease such as heart disease, diabetes, cancer and stroke. Heart disease, in particular, became seen as an 'epidemic'. After World War II, increase research funding by the American government made possible the development of a new research method - the long-term prospective epidemiological study - and a new way of understanding chronic diseases as caused by risk factors such as high blood pressure, cigarette smoking and high blood cholesterol. Excess body weight was includes in this list of risk factors, and so became an object in increased medical attention. The thesis then outlines how a new public health coalition was formed around obesity in the 1970s by British biomedical researchers working on topics in the fields of nutrition, diabetes and coronary heart disease. It describes the development of what I call the 'individual paradigm' of obesity which characterises the condition as an individual problem that leads to heart disease and mechanical complaints and is treatable by weight loss diets. It then describes two key features of British obesity science in the 1980s and 1990s. The first of these is the adoption of the Body Mass Index and the standard cut-off points that are used to define overweight and obesity, which together facilitate the collection and dissemination of data on changes in average body weights, The second is the energy balance model of weight regulation, which served to unify the diverse disciplinary approaches to biomedical research incorporated into this new knowledge, but which could not account for the high rates of failure acknowledged as occurring with conventional treatments such as weight loss diets, anorectic drugs and bariatric surgery. The thesis describes how researchers in the field of obesity science than extended their institutional research to participate in the production of a series of reports for the World Health Organization, including one on the global epidemic of obesity published in 2000. This new platform, combined with data produced by prospective studies, enabled them to disseminate a new understanding of obesity and overweight - what I call the 'environmental paradigm' - which characterises it as a global health problem associated with an increased risk of many diseases and caused by structural factors such as inappropriate diet and sedentary lifestyles. Despite refocusing attention of structural determinants of ill health, however, public health experts were constrained by considerations of political practicality and commercial interest when calling for preventive measures in the areas of diet and physical activity. The thesis concludes by considering the different ways in which scholars have theorised the epidemiological transition from infectious to chronic disease. Drawing on approaches from the health inequalities literature, it argues that the conventional framings of chronic disease epidemiology have tended systematically to obscure structural links between obesity and other forms of diet-related ill health on the one hand, and relative poverty on the other.
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Cardiovascular disease and diabetes or renal insufficiency : the risk of ischemic stroke and risk factor interventionJakobsson, Stina January 2015 (has links)
Background In patients with diabetes mellitus (DM) or chronic kidney disease (CKD), established cardiovascular disease (CVD) is associated with an increased risk of recurrent events and poor outcome. Ischemic stroke after an acute myocardial infarction (AMI) is a devastating event that carries high risks of decreased patient independence and death. Among patients with DM or CKD, the risk of an ischemic stroke within a year following an AMI is not known. Improved risk factor control is required to reduce the likelihood of CVD recurrence. Guidelines recommend target lipid profile and blood pressure values; however, data show that these targets are often not met. Therefore, there remains an urgent need for improved cardiovascular secondary preventive follow- up. Aims The aims of the present studies were to define trends in the incidence and predictors of ischemic stroke after an AMI in patients with DM or CKD. Furthermore to assess whether secondary preventive follow-up with nurse-based telephone follow-up including medication titration after CVD improves risk factor values in patients with DM or CKD and to investigate if this method performs better than usual care to implement a new treatment guideline in diabetic patients. Methods To assess the risk of post-AMI ischemic stroke, patient data were obtained from the Swedish Register of Information and Knowledge about Swedish Heart Intensive Care Admissions (RIKS-HIA). In separate studies, we compared a total of 173 233 AMI patients with and without DM, and 118 434 AMI patients with and without CKD. Within the nurse-based age-independent intervention to limit evolution of disease (NAILED) trial, we investigated a nurse-based cardiovascular secondary preventive follow-up protocol. Patients with acute coronary syndrome, stroke, or transient ischemic attack were randomized to receive either nurse-based telephone follow-up (intervention) or usual care (control). Low-density lipoprotein (LDL-C) levels and blood pressure (BP) were measured at 1 month (baseline) and 12 months post- discharge. Intervention patients with above-target baseline values received medication titration to achieve treatment goals, while the measurements for control patients were forwarded to their general practitioners for assessment. We calculated the changes in LDL-C level and BP between baseline and 12 months post-discharge, and compared these changes between 225 intervention patients and 215 control patients with concurrent DM or CKD. During the course of the NAILED trial, new secondary preventive guidelines for DM patients were released, including a new LDL-C target value. To assess adherence to the new guidelines within the NAILED trial, we compared LDL-C levels in the 101 intervention patients and 100 control patients with DM. Results Ischemic stroke after AMI The rates of ischemic stroke within one-year after admission for an AMI decreased over time, from 7.1% in 1998–2000 to 4.7% in 2007–2008 among DM patients, and from 4.2% to 3.7% during the same time periods for non-diabetic patients. Lower stroke risk was associated with percutaneous coronary intervention (PCI) and initiation of secondary preventive treatments in-hospital. In-hospital ischemic stroke occurred in 2.3% of CKD patients and 1.2% of non-CKD patients, with no change in these incidences over time. The rates of one-year post- discharge ischemic stroke decreased between 2003–2004 and 2009–2010 from 4.1% to 2.5% among CKD patients, and from 2.0% to 1.3% among non-CKD patients. Lower rates of post-discharge stroke were associated with PCI and statins. Cardiovascular secondary preventive follow-up Among DM and CKD patients with above-target baseline values in the NAILED trial, the median LDL-C value at 12 months was 2.2 versus 3.0 mmol/L (p<0.001) and median systolic BP was 140 versus 145 mmHg (p=0.26) for intervention and control patients, respectively. Before the guideline change, 96% of the intervention and 70% of the control patients reached the target LDL-C value (p<0.001). After the guideline change, the corresponding respective proportions were 65% and 36% (p<0.001). Conclusion Ischemic stroke is a fairly common post-AMI complication among patients with DM and CKD. This risk of stroke has decreased during recent years, possibly due to the increased use of evidence-based therapies. Compared with usual care, cardiovascular secondary prevention including nurse-based telephone follow-up improved LDL-C values at 12 months after discharge in patients with DM or CVD, and led to more efficient implementation of new secondary preventive guidelines.
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HEALTH MOTIVATION: ITS COMPONENTS AND THEIR RELATIONSHIPS WITH COMPLIANCE AMONG HEMODIALYSIS PATIENTS.OLIVAS, GUADALUPE SOTO. January 1986 (has links)
This descriptive, correlational designed study was concerned with noncompliance with therapeutic regimens, a pervasive clinical problem which is confounded with the lack of a strong link among theory, research and practice. The focus was on one of the constructs included the Reciprocal Interaction Model of Compliance Behaviors, which was derived using a modified grounded theory methodology and following various theory building prescriptions. The overall purpose was to begin to evaluate the goodness-of-fit of this empirically, qualitatively and retroductively generated explanation of compliance behaviors. The specific aims were to develop, refine and test a 6-point response, 64-item Likert-type instrument, Olivas' Health Motivation Scale - OHMS, that adequately measures the construct, Health Motivation: the force within the patient which is developed as he/she gains experience with his/her illness as a function of time. It has two major dimensions: expectations and values. Health Motivation as indexed by an expectations/values interaction was predicted to impact compliance as measured by dietary and medication measures, both objective and subjective estimates. Using trait and nomological construct perspectives, the OHMS was systematically evaluated by internal and external association criteria and therefore validity and reliability estimates, with a purposive sample of 84 heterogeneous hemodialysis patients who represented two cultures (Anglo and Hispanic), varying in gender, age and length in hemodialysis. Internal consistency reliability and trait construct validity were derived through Cronbach's alpha and principal components factor analysis. Refined OHMS Scales had alphas and thetas ranging from .58 to .89. Explained scale variance ranged from .54 to .84. Epistemic coefficients, the validity links between concept and operational measures, ranged from .76 to .94. Internal validity of the design, estimated through multiple regression, was concluded to be satisfactory. External association assessment via multiple regression produced mixed findings. Select expectations, in linear combination with select values, explained varying degrees of the variance, in select compliance measures, R² = .11 to .44. Through empirical modeling via path analysis, select subject characteristics (ethnicity, length on dialysis, age) were found to have direct or indirect relationships with compliance. Theory, research, and practice based limitations and recommendations were made from the results of the study. (Abstract shortened with permission of author.)
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Maintaining well-being in arthritis: Mediators of the adversive condition.Arslanian, Christine Lucy. January 1993 (has links)
The purpose of this study was to test the relationships between and among the concepts of severity of illness, dependency, uncertainty, functional status and the mediators of self-esteem and mastery relative to the outcome of wellbeing. The conceptual framework was adapted from various sources in the literature which support the concept of wellbeing as an important outcome in arthritis. Evidence also supports self-esteem and mastery as mediators of the chronic illness experience. Dependency, uncertainty and functional status have been shown to be predictors of wellbeing but have never been tested as a complete paradigm. The sample for the study was 128 patients with either rheumatoid arthritis or osteoarthritis. Subjects completed 7 questionnaires which measured the 7 variables under study. Descriptive statistics were used to examine the demographic characteristics of the sample. Multiple regression technique was used to empirically test the predicted theoretical concepts and to estimate predictive validity for the theoretical concepts. The results demonstrated that when self-esteem was used in the causal model, 58% of the variance in wellbeing was explained by self-esteem and uncertainty. When mastery was included instead of self-esteem 52% of the variance of wellbeing was explained by mastery and uncertainty. When tested as mediators, both self-esteem and mastery emerged as significant mediators of dependency, uncertainty and functional status relative to wellbeing. These results are of clinical use to nurses who, by virtue of working with these patients on a daily basis, are in a position to intervene with actions which encourage positive self-esteem and maintain mastery over the environment. If these actions are successful, then wellbeing can be maintained for those patients diagnosed with arthritis.
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