A Benefit-Risk Assessment Framework for Development of Clinical Guidelines in Diagnostic Radiology

Thesis (Ph.D.)--University of Washington, 2015-12

In postmenopausal women with osteoporosis, denosumab significantly improved trabecular bone score (TBS), an index of trabecular microarchitecture

Background/Purpose: The trabecular bone score (TBS), a novel graylevel texture index determined from lumbar spine DXA scans, correlates with 3D parameters of trabecular bone microarchitecture known to predict fracture. TBS may enhance the identification of patients at increased risk for vertebral fracture independently of bone mineral density (BMD) (Boutroy JBMR 2010; Hans JBMR 2011). Denosumab treatment for 36 months decreased bone turnover, increased BMD, and reduced new vertebral fractures in postmenopausal women with osteoporosis (Cummings NEJM 2009). We explored the effect of denosumab on TBS over 36 months and evaluated the association between TBS and lumbar spine BMD in women who had DXA scans obtained from eligible scanners for TBS evaluation in FREEDOM. Methods: FREEDOM was a 3-year, randomized, double-blind trial that enrolled postmenopausal women with a lumbar spine or total hip DXA T-score __2.5, but not __4.0 at both sites. Women received placebo or 60 mg denosumab every 6 months. A subset of women in FREEDOM participated in a DXA substudy where lumbar spine DXA scans were obtained at baseline and months 1, 6, 12, 24, and 36. We retrospectively applied, in a blinded-to-treatment manner, a novel software program (TBS iNsightR v1.9, Med-Imaps, Pessac, France) to the standard lumbar spine DXA scans obtained in these women to determine their TBS indices at baseline and months 12, 24, and 36. From previous studies, a TBS _1.35 is considered as normal microarchitecture, a TBS between 1.35 and _1.20 as partially deteriorated, and 1.20 reflects degraded microarchitecture. Results: There were 285 women (128 placebo, 157 denosumab) with a TBS value at baseline and _1 post-baseline visit. Their mean age was 73, their mean lumbar spine BMD T-score was _2.79, and their mean lumbar spine TBS was 1.20. In addition to the robust gains in DXA lumbar spine BMD observed with denosumab (9.8% at month 36), there were consistent, progressive, and significant increases in TBS compared with placebo and baseline (Table & Figure). BMD explained a very small fraction of the variance in TBS at baseline (r2_0.07). In addition, the variance in the TBS change was largely unrelated to BMD change, whether expressed in absolute or percentage changes, regardless of treatment, throughout the study (all r2_0.06); indicating that TBS provides distinct information, independently of BMD. Conclusion: In postmenopausal women with osteoporosis, denosumab significantly improved TBS, an index of lumbar spine trabecular microarchitecture, independently of BMD.

Subclinical thyroid dysfunction and the risk of heart failure events: an individual participant data analysis from 6 prospective cohorts.

BACKGROUND: American College of Cardiology/American Heart Association guidelines for the diagnosis and management of heart failure recommend investigating exacerbating conditions such as thyroid dysfunction, but without specifying the impact of different thyroid-stimulation hormone (TSH) levels. Limited prospective data exist on the association between subclinical thyroid dysfunction and heart failure events. METHODS AND RESULTS: We performed a pooled analysis of individual participant data using all available prospective cohorts with thyroid function tests and subsequent follow-up of heart failure events. Individual data on 25 390 participants with 216 248 person-years of follow-up were supplied from 6 prospective cohorts in the United States and Europe. Euthyroidism was defined as TSH of 0.45 to 4.49 mIU/L, subclinical hypothyroidism as TSH of 4.5 to 19.9 mIU/L, and subclinical hyperthyroidism as TSH <0.45 mIU/L, the last two with normal free thyroxine levels. Among 25 390 participants, 2068 (8.1%) had subclinical hypothyroidism and 648 (2.6%) had subclinical hyperthyroidism. In age- and sex-adjusted analyses, risks of heart failure events were increased with both higher and lower TSH levels (P for quadratic pattern <0.01); the hazard ratio was 1.01 (95% confidence interval, 0.81-1.26) for TSH of 4.5 to 6.9 mIU/L, 1.65 (95% confidence interval, 0.84-3.23) for TSH of 7.0 to 9.9 mIU/L, 1.86 (95% confidence interval, 1.27-2.72) for TSH of 10.0 to 19.9 mIU/L (P for trend <0.01) and 1.31 (95% confidence interval, 0.88-1.95) for TSH of 0.10 to 0.44 mIU/L and 1.94 (95% confidence interval, 1.01-3.72) for TSH <0.10 mIU/L (P for trend=0.047). Risks remained similar after adjustment for cardiovascular risk factors. CONCLUSION: Risks of heart failure events were increased with both higher and lower TSH levels, particularly for TSH ≥10 and <0.10 mIU/L.

Subclinical thyroid dysfunction, cardiac function, and the risk of heart failure. The Cardiovascular Health study.

OBJECTIVES: The goal of this study was to determine whether subclinical thyroid dysfunction was associated with incident heart failure (HF) and echocardiogram abnormalities. BACKGROUND: Subclinical hypothyroidism and hyperthyroidism have been associated with cardiac dysfunction. However, long-term data on the risk of HF are limited. METHODS: We studied 3,044 adults>or=65 years of age who initially were free of HF in the Cardiovascular Health Study. We compared adjudicated HF events over a mean 12-year follow-up and changes in cardiac function over the course of 5 years among euthyroid participants, those with subclinical hypothyroidism (subdivided by thyroid-stimulating hormone [TSH] levels: 4.5 to 9.9, >or=10.0 mU/l), and those with subclinical hyperthyroidism. RESULTS: Over the course of 12 years, 736 participants developed HF events. Participants with TSH>or=10.0 mU/l had a greater incidence of HF compared with euthyroid participants (41.7 vs. 22.9 per 1,000 person years, p=0.01; adjusted hazard ratio: 1.88; 95% confidence interval: 1.05 to 3.34). Baseline peak E velocity, which is an echocardiographic measurement of diastolic function associated with incident HF in the CHS cohort, was greater in those patients with TSH>or=10.0 mU/l compared with euthyroid participants (0.80 m/s vs. 0.72 m/s, p=0.002). Over the course of 5 years, left ventricular mass increased among those with TSH>or=10.0 mU/l, but other echocardiographic measurements were unchanged. Those patients with TSH 4.5 to 9.9 mU/l or with subclinical hyperthyroidism had no increase in risk of HF. CONCLUSIONS: Compared with euthyroid older adults, those adults with TSH>or=10.0 mU/l have a moderately increased risk of HF and alterations in cardiac function but not older adults with TSH<10.0 mU/l. Clinical trials should assess whether the risk of HF might be ameliorated by thyroxine replacement in individuals with TSH>or=10.0 mU/l.

Registered nurses' perceptions of factors impacting on their continuing education /

This qualitative study examined the effects of hospital restructuring on a group of nurses at a community hospital. Eleven nurses were asked questions in order to gain insight into their experience in this situation. Ten of these participants were female, and one was male. The intent was to gather information about how restructuring has affected their lives, including, their motivational factors and barriers to participation in continuing education, and their descriptions of their workplace environment. Audiotaped interviews were conducted on two occasions to obtain this data. Emergent themes included the nurses' comments about continuing education, motivational factors, barriers that included geography and time, reactions of co-workers, restructuring, the College of Nurses' Quality Assurance Program including peer feedback, and performance appraisals. The literature review compares the barriers and motivational factors to the previous research findings. Thus, this study gave voice to the experience of this group of nurses, working in a healthcare setting that is involved in restructuring. This information is important to the healthcare system, since many areas are involved in restructuring. The whole process, if it is to be successful, depends on the frontline workers, namely the nurses. Thus, if there is anything to be learned from this group of people, that could be used to improve this progression, everyone would benefit from this information, were it to be implemented. Everyone is a stakeholder in the quality of healthcare in our province. The frontline workers are the ones that hold the vantage point to be able to provide suggestions for the changes needed to successful. These nurses are not just motivated by work issues however, and educating them and motivating them will also improve the care provided through increased knowledge and enhanced self-esteem.

Changing roles of nurse educators employed in acute and chronic care settings : the impact of professional and statutory mandates in Ontario at four sites of one hospital corporation /

The role of the hospital-employed nurse educator is evolving. Factors influencing this change include the introduction of standards for nurse educators by the College of Nurses of Ontario (CNO), a change in the way nurses are educated, the emergence of nursing as a profession, and hospital restructuring as a result of budgetary constraints. Two of these influencing factors: the introduction of the updated Standards of Practice for Registered Nurses and Registered Practical Nurses (1996) and hospital restructuring occurred over the last 7 years at several hospitals in southern Ontario. Current literature as well as the Standards of Practice (1996) were utilized to examine the current roles and responsibilities of nurse educators and subsequently develop a questionnaire to study the impact of these influencing factors on the role of the nurse educator. This questionnaire was piloted and revised before its distribution at 4 hospitals in southern Ontario. Twenty-five of the 41 surveys (61%) distributed were returned for analysis. The data reflected that the Standards of Practice had a positive influence on the role of the nurse educator, while hospital restructuring had a negative impact. In addition, many of the roles and responsibilities identified in the literature were indeed part of the current role of nurse educators, as well as several responsibilities not captured in the literature. The predictions for the future of this role in its current state were not positive given the financial status of the health care system as well as the lack of clarity for the role and the current level ofjob satisfaction among practicing nurse educators. However, a list of recommendations were generated which, if implemented, could add clarity to the role and improve job satisfaction. This could enhance the retention of current nurse educators and the possibility of recruiting competent nurse educators to the role in the future.

Developmental patterns of individiuals within a sensory-based learning environment in art education : insights emerging from a case study /

My research permitted me to reexamine my recent evaluations of the Leaf Project given to the Foundation Year students during the fall semester of 1997. My personal description of the drawing curriculum formed part of the matrix of the Foundation Core Studies at the Ontario College of Art and Design. Research was based on the random selection of 1 8 students distributed over six of my teaching groups. The entire process included a representation of all grade levels. The intent of the research was to provide a pattern of alternative insights that could provide a more meaningful method of evaluation for visual learners in an art education setting. Visual methods of learning are indeed complex and involve the interplay of many sensory modalities of input. Using a qualitative method of research analysis, a series of queries were proposed into a structured matrix grid for seeking out possible and emerging patterns of learning. The grid provided for interrelated visual and linguistic analysis with emphasis in reflection and interconnectedness. Sensory-based modes of learning are currently being studied and discussed amongst educators as alternative approaches to learning. As patterns emerged from the research, it became apparent that a paradigm for evaluation would have to be a progressive profile of the learning that would take into account many of the different and evolving learning processes of the individual. A broader review of the student's entire development within the Foundation Year Program would have to have a shared evaluation through a cross section of representative faculty in the program. The results from the research were never intended to be conclusive. We realized from the start that sensory-based learning is a difficult process to evaluate from traditional standards used in education. The potential of such a process of inquiry permits the researcher to ask for a set of queries that might provide for a deeper form of evaluation unique to the students and their related learning environment. Only in this context can qualitative methods be used to profile their learning experiences in an expressive and meaningful manner.

Perceptions of some teachers about the similarities and/or differences in teaching online versus in a classroom environment /

The introduction of computer and communications technology, and particularly the internet, into education has opened up some new possibilities for teaching and learning. Courses designed and delivered in an online environment offer the possibility of highly interactive and individually focussed teaching and learning experiences. However, online courses also present new challenges for both teachers and students. A qualitative study was conducted to explore teachers' perceptions about the similarities and differences in teaching in the online and face-to-face (F2F) environments. Focus group discussions were held with 5 teachers; 2 teachers were interviewed in depth. The participants, 3 female and 2 male, were full-time teachers from a large College of Applied Arts & Technology in southern Ontario. Each of them had over 10 years of F2F teaching experience and each had been involved in the development and teaching of at least one online course. i - -; The study focussed on how teaching in the online environment compares with teaching in the F2F environment, what roles teachers and students adopt in each setting, what learning communities mean online and F2F and how they are developed, and how institutional policies, procedures, and infrastructure affect teaching and learning F2F and online. This study was emic in nature, that is the teachers' words determine the themes identified throughout the study. The factors identified as affecting teaching in an online environment included teacher issues such as course design, motivation to teach online, teaching style, role, characteristics or skills, and strategies. Student issues as perceived by the teachers included learning styles, role, and characteristics or skills. As well, technology issues such as a reliable infrastructure, clear role and responsibilities for maintaining the infrastructure, support, and multimedia capability affected teaching online. Finally, administrative policies and procedures, including teacher selection and training, registration and scheduling procedures, intellectual property and workload policies, and the development and communication of a comprehensive strategic plan were found to impact on teaching online. The teachers shared some of the benefits they perceived about teaching online as well as some of the challenges they had faced and challenges they perceived students had faced online. Overall, the teachers feh that there were more similarities than differences in teaching between the two environments, with the main differences being the change from F2F verbal interactions involving body language to online written interactions without body language cues, and the fundamental reliance on technology in the online environment. These findings support previous research in online teaching and learning, and add teachers' perspectives on the factors that stay the same and the factors that change when moving from a F2F environment to an online environment.

An exploratory study of nurses' perceptions of their action learning experience /

Each year, the College of Nurses of Ontario (CNO) requires all registered nurses and registered practical nurses in Ontario to complete a Reflective Practice learning activity. In doing so, nurses are expected to perform a self- assessment, identify a practice problem or issue, create and implement a personal learning plan, and evaluate the learning and outcomes accomplished. The process and components of CNO's Reflective Practice program are very similar to an Action Learning activity. The purpose of this qualitative research was to explore the perceptions of 1 1 nurses who completed at least 1 Action Learning activity. Data analysis of their comments provided insight into their perceptions of the Action Learning experience, perceptions of the negative and positive characteristics of various activities within the Action Learning process, and perceptions of barriers or challenges within this experience. The author concluded that participants perceived their Action Learning activities to be a positive experience because the process focused on practice problems and issues, enhanced thinking about practice problems, and achieved practice-relevant outcomes. However, the results indicated that self-directed learning and journal writing were difficult activities for some participants, and some experienced negative emotional responses during reflection. The research concluded that barriers to implementation of Action Learning include a lack of understanding of the process and a perceived lack of support from employers.

An exploration of the impact of a mandatory quality assurance program on the staff nurse's commitment to professional development /

This study explored experiences in relation to the impact of the College of Nurses of Ontario's (CNO's) mandatory Quality Assurance (QA) program on registered nurses (RNs) working in a clinical setting of an acute care hospital. A qualitative descriptive research design was used and data collection was done in 2 stages. First, a survey with open-ended questions was given to 45 nurses. Second, 8 respondents from the survey were interviewed using a semistructured format. Data were obtained from 2 groups-diploma-prepared and post diploma-prepared RNs. Findings demonstrated that the CNO's QA program had varying influences on the RNs' learning paths, and these differences appeared to be related to the educational background of the individual. The diploma-prepared nurses reported that their commitment to professional development was influenced by their level of internal motivation, the pressures associated with time, and the need for a strong external motivator, namely the obligation of management to conduct formal performance appraisals. They further reported that the QA program played a part in positively altering their commitment to continuing education. The post-diploma baccalaureate nurses reported that the QA program played a positive role in influencing their ongoing learning, along with their level of internal motivation, the work and health care environment, and the element of professionalism. Several implications for nursing practice, theory, and fiirther research also became evident.

Foreign trained teachers : the emergence of the right to practise their profession in Ontario

The purpose of this thesis is to examine the impact of 2 recent legal events, specifically the Fair Access to Regulated Professions Act (2006) and Siadat v. Ontario College of Teachers (2007) decision, with regards to the opportunity of foreign trained teachers to practice their profession in Ontario. The emphasis is on the case of Fatima Siadat, who was a teacher in Iran but was unable to satisfy all the licensing requirements of the Ontario College of Teachers and consequently was unable to practise her profession in Ontario. When the Ontario College of Teachers Appeals Committee upheld the previous decision of the Ontario College of Teachers Registrar to refuse to issue her a teacher's certificate, Ms. Fatima Siadat decided to initiate a lawsuit. Ms. Fatima Siadat challenged the decision ofthe Ontario College of Teachers Appeals Committee by raising a question of applicability of human rights legislation (i.e., The Ontario Human Rights Code, 1990) on the Ontario College of Teachers' decisions. The Ontario Superior Court of Justice decided in January of2007 in favour of Ms. Fatima Siadat (Siadat v. Ontario College of Teachers , 2007) and ordered that her licensing application be reconsidered by the Ontario College of Teachers Appeals Committee. In this thesis the author argues that the Fatima Siadat decision, together with the Fair Access to Regulated Professions Act, 2006, will likely make a significant contribution to enhancing the access of foreign trained teachers and other professionals to practice their regulated professions in Ontario.

Reeves Hall, Chapman College, Orange, California

Reeves Hall, Chapman College, Orange, California. This historical building (2 floors, 17,862 sq.ft.), completed in 1913 is named in honor of George N. Reeves, president of the university from 1942 to 1956. It is listed in the National Registry for Historical Buildings and houses the Kathleen Muth Reading Center, College of Lifelong Learning, and the School of Education. Originally constructed to serve Orange Union High School, it was designed along with its twin building by Santa Ana architect Frank Eley. Acquired by Chapman College in 1954.

Reeves Hall, Chapman College, Orange, California

Reeves Hall, Chapman College, Orange, California. This historical building (2 floors, 17,862 sq.ft.), completed in 1913 is named in honor of George N. Reeves, president of the university from 1942 to 1956. It is listed in the National Registry for Historical Buildings and houses the Kathleen Muth Reading Center, College of Lifelong Learning, and the School of Education. Originally constructed to serve Orange Union High School, it was designed along with its twin building by Santa Ana architect Frank Eley. Acquired by Chapman College in 1954. Stamped on the back: Taylor Publishing Co. Job Number 30232 - Pict. No. 4 - Page No. 56 - Chapman College - Orange, Calif.

Reeves Hall, Chapman College, Orange, California

Reeves Hall, Chapman College, Orange, California. This historical building (2 floors, 17,862 sq.ft.), completed in 1913 is named in honor of George N. Reeves, president of the university from 1942 to 1956. It is listed in the National Registry for Historical Buildings and houses the Kathleen Muth Reading Center, College of Lifelong Learning, and the School of Education. Originally constructed to serve Orange Union High School, it was designed along with its twin building by Santa Ana architect Frank Eley. Acquired by Chapman College in 1954.