A Thesis submitted to The University of Arizona College of Medicine - Phoenix in partial fulfillment of the requirements for the Degree of Doctor of Medicine. / Cancer‐related fatigue (CRF) is a well‐documented symptom among gynecologic oncology patients. However, there is little known about the etiology, and treatment options are currently suboptimal. While the lack of knowledge surrounding the intricacies of CRF impedes effective care, there is arguably a more serious barrier to delivering adequate treatment. Fatigue symptoms are highly underreported to physicians making it impossible to offer treatment to a large subsection of patients. This study will focus specifically on gynecologic oncology patients, a population with a staggering prevalence of CRF. The purpose of this study is to identify clinical, psychosocial, and lifestyle characteristics that may be associated with the underreporting of fatigue specifically in gynecologic oncology patients. The design of this study is a cross‐sectional survey. 89 subjects were recruited from three outpatient sites. Inclusion criteria included: (a) women age ≥18 years old with a known ovarian, uterine, cervical, vaginal, vulvar, or primary peritoneal cancer; (b) Currently attending physician’s office hours and/or undergoing chemotherapy at one of the above listed centers. This study will focus specifically on the reporting of CRF in gynecologic oncology patients. Results showed that barriers to reporting fatigue were significantly correlated with the chemotherapy cycle a patient was undergoing. Additionally, the date of last treatment, a patient’s weight, and the cancer stage was associated with higher levels of underreporting in this population. The prevalence of cancer related fatigue is staggering; however, there is limited research as to why patients are underreporting such a significant symptom to their health care team. With the knowledge from this study, screening for fatigue can become more efficient by targeting women in specific chemotherapy cycles. Practitioners can also use this data to identify patients with high‐risk characteristics that might contribute to their unwillingness to discuss fatigue symptoms.

This study examined the potential significant differences in the distribution of adverse drug reactions (ADRs) by reporter (consumer versus physician) and patient outcome at case and event level. This study also contains exploratory questions to evaluate reporting of ADRs by consumers versus physician by system organ class (SOC) and reporter demographics within the United States Food & Drug Administration Adverse Event Reporting System (FAERS). The theoretical foundation applied in this quantitative study was the social amplification of risk framework. Data from the second quarter of 2016 were obtained from FAERS, and a total of 87,807 ADR reports corresponding to 143,399 ADRs were analyzed by utilizing the chi-square test, the odds ratio, and logistic regression. Cross-sectional design was employed to compare reporting of ADRs at the case and event level (case-based and event-based analyses, respectively) between reporters (consumer versus physician), specifically, for patient outcome, as well as SOC and reporter demographics. For both the case-based and event-based analyses, findings revealed that consumers reported more serious ADRs in comparison to physicians. Furthermore, findings confirmed a difference in ADR reporting between consumers and physicians depending on SOC groups. Additionally, consumers reported more nonserious ADRs in comparison to physicians. The results from this study may have implications for positive social change by augmenting pharmacovigilance systems at a national and international level to identify risks and risk factors spontaneously reported after drugs have been on the market.

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Spreadsheets are often used for data input and resource planning, but studies in health care indicate various barriers causing under-reporting. Other studies suggest mobile reporting systems could prevent under-reporting. Nevertheless, the importance of smartphone-based reporting systems within industries is scarcely researched. This thesis studies the importance of such systems and their usability within an industrial context, and the connection to sustainable resource planning. A literature study was conducted and a smartphone prototype was developed. Using a qualitative and mixed-methods approach, eight industrial employees currently using a spreadsheet-based reporting system were asked about barriers to data reporting and the importance of smartphone-based reporting systems. After testing the prototype, they were asked about the importance of different usability-related aspects. The recordings were transcribed and the collected data was sorted and analyzed. This was done to understand the reasoning behind the aspects perceived as the most significant among the respondents. The case study showed that not remembering was regarded as the most important barrier to data reporting among end users of a spreadsheet-based reporting system. Smartphone-based reporting systems that are easy to use with daily reporting and reminders sent to the phone were considered by all respondents to have a positive impact on reporting frequency. However, privacy concerns and phone-related distractions could be issues if no work-related smartphones are provided. This thesis is of interest to developers of smartphone applications with usability in mind, and to companies striving for more efficient and cost-effective resource planning. On a larger scale, it provides insight into how smartphone-based reporting based on usability could lead to improved sustainability through more effective resource usage.

Globally, neonatal mortality has remained basically unchanged for the last three to four decades and every year almost four million newborns die before reaching one month of age. This persistent mortality is related to an invisibility of the newborn child in policies and statistics and a neglect of health care decision-makers, planners and practitioners to deliver a perinatal continuum of care. In recent years attention has however been brought to the unchanged neonatal mortality in an effort to improve survival. The present thesis seeks to increase understanding of obstacles for better neonatal survival. The studies performed are undertaken as sub-studies to the NeoKIP project in Quang Ninh province in northern Vietnam, a randomized controlled trial of knowledge implementation for improved neonatal survival (Neonatal Health – Knowledge Into Practice, ISRCTN 44599712). In the first paper we investigated and discussed the scope of invisibility of neonatal mortality through measuring the accuracy of official statistics on neonatal deaths. The second paper reports an inquiry of determinants of neonatal mortality by use of a population-based case-referent design. Paper III and IV analyse delivery care utilization and care seeking patterns prior to and at delivery using narratives and GIS technique. There was a substantial under-reporting of neonatal mortality in the official statistics, with study results showing a four times higher neonatal mortality rate in Quang Ninh province than reported to the Ministry of Health. This neonatal mortality rate of 16/1000 live births (as compared to 4.2/1000 in official reports) was unevenly distributed in the province, showing large geographical discrepancies. In the rural and remote areas of Vietnam education level is lower and the concentrations of ethnic minorities and poor households are higher. Ethnic minority belonging was associated with a more than doubled risk of neonatal death compared to the hegemonic group of Kinh (OR 2.08 CI 95 % 1.39 – 3.10). This increased risk was independent of household economic status or maternal education level. Neonatal mortality was also associated with home deliveries, non-attendance to antenatal care and distance to the health care facilities. However, ethnic minority mothers still had an increased risk of experiencing a neonatal death even if they attended antenatal care, delivered at or lived close to a health facility. The invisibility of the neonatal period in health information systems hides the true width of the neonatal mortality challenge. By not acknowledging the problem, the marginalization of already disadvantaged groups continues, leaving ethnic minority babies with an elevated risk of dying during the first month in life. This example of ethnic inequity highlights the importance to target those most in need. The studies of the present thesis should therefore be looked upon as a contribution to the struggle to illuminate the global burden of neonatal mortality.

The purpose of this narrative study is to highlight social workers' experiences of threats and violence within their profession, as well as the variety of resources to fend off, remedy and manage the risk of threats and violence. The present problem is how threats and violence are underreported, partly due to social workers' views on their own profession and a work climate that might not encourage reporting incidents. Previous studies have shown high prevalence of threats and violence within social work and consequences that follow, such as high levels of stress, leading to burnout. Other studies found that the fear of being exposed to threats and violence can result in self-censorship, thereby limiting autonomy and professional judgment. Through interviews we found that social workers had experienced violence and threats of different sorts, primarily verbal threats. The overall perception was of understanding nature due to injustice that many clients face, resulting in expressions of strong emotions. However, some social workers described their work as characterized by imminent threats, rather than fear of being exposed. The preventing resources provided at the workplace are described as mostly effective and fulfilling of its purpose, while others find that they create unnecessary distance between them and clients. The social workers perceive themselves as fairly prepared for violent or threatening situations, mainly through their education, but emphasize experience over any type of education. They also emphasize the support from colleagues and managers as valuable and important resources. By highlighting the narrative of social workers we hope to bring awareness to this issue and encourage an open dialogue.

Mandatory notification of disease forms the backbone of disease surveillance in New Zealand and overseas. Notification data is used by public health professionals and academics to identify cases requiring public health control, monitor disease incidence and distribution, and in epidemiological research. However, there is emerging evidence that notification rates do not accurately reflect the true extent of notifiable diseases within the community, resulting in the underascertainment of many notifiable cases. While adequate surveillance does not necessarily require that all cases of notifiable disease be captured, the systematic underascertainment of disease can have significant implications for perceived spatial and demographic trends in disease prevalence; potentially threatening the credibility of spatial epidemiological research by under or overestimating the burden of disease in different populations. There is evidence that systematic underascertainment occurs as a result of the differential actions of laboratories and general practitioners. It has also been recognised that that underascertainment can be influenced by a patient's willingness to seek medical attention and participate in laboratory tests. However, few studies have investigated whether these factors systematically influence notification either in New Zealand or overseas. Furthermore, the discipline of health geography has been slow to engage with this topic of public health importance, despite the inherently spatial nature of the processes involved, and the close ties to the geographic literature on health service utilization and healthcare provision. This thesis explores the spatial and temporal variation in notification rates in New Zealand for the period 1997-2005 and the potential relationships between notification rates and different variables. Unlike many underascertainment studies, which have used individual data and capture-recapture methods, data constraints inspired a unique ecological approach to investigating the factors which may be associated with notification in New Zealand. Variables were divided into categories based on Anderson's behavioural model for healthcare utilization and the influence of these variables on notification was determined through multiple regression analyses. The main findings of this research indicate that in New Zealand notification rates have increased during the period 1997-2005 and that there is a north-south gradient in notifications, with substantially lower rates in the North Island than in the South Island. Furthermore, it is also evident that the variables associated with notification vary according to disease, spatial aggregation and spatial scale. Notification rates are significantly associated with a range of predisposing and enabling factors which might influence patient choice to consult for many frequently underascertained diseases. More variation in enteric diseases is explained by the independent variables analysed than the variation in non-enteric diseases. However, further research into these relationships, and underascertainment in general, is required before firm conclusions can be drawn.

Obesity is a serious public health crisis and recent estimates of its incidence are the highest in United States history, with 35% and 17% of American adults and children affected, respectively. The clinical definition of adult obesity is operationalized as a body mass index (BMI) greater than 30 kg/m2. Although the prevalence of common obesity has increased dramatically over the past 30 years–largely thought to be due to changes in the environment, such as high calorie diets and sedentary lifestyles—twin and family studies have shown consistently that relative body weight is under considerable genetic influence in both children and adults, with heritability estimates ranging from 40% to 90%. Elucidating the genetic and environmental liability to relative body weight is an important public health endeavor. To further our understanding of the genetics of BMI and common complex obesity, several studies are described that integrate clinical, twin, and genome-wide association (GWAS) methodology in the context of genetic risk scores, clinical risk prediction, development across adolescence into adulthood, and comorbidity with depression symptoms and smoking behavior. First, in two cross-sectional genetic association studies, the utility of genetic risk sum scores (GRSS) were assessed, which summarize the total number of risk alleles, as an alternative form of replication and for potential clinical utility for obesity risk prediction. Next, since there has been only limited research on when during development BMI-associated variants begin influencing BMI, a longitudinal twin study was utilized to assess the effects of adult-validated BMI-SNPs across adolescence into adulthood. In addition, obesity is comorbid with numerous medical conditions including cardiovascular disease, insulin-resistance and some forms of cancer, as well as, various psychiatric disorders including eating disorders, mood disorders, and substance use. The next series of studies aimed to understand phenotypic and genetic associations between BMI/obesity and binge eating disorder (BED), depression symptoms and smoking behavior. Using a clinical sample of overweight and obese women with and without BED, the relationship of BED, food intake and internalizing symptoms of depression and anxiety was examined. Next, twin study methodology was used to investigate if shared genetic and/or environmental liability was responsible for phenotypic associations found between BMI, depression symptoms, and impulsivity. Finally, a genetic association study aimed at investigating whether genetic variants were associated with multiple behaviors, body composition and smoking behavior, or were trait-specific is presented. By utilizing several samples and methodologies and by pursuing methods development, a comprehensive approach is presented that is hoped to represent a more powerful evidence-based strategy to understanding the genetic and environmental determinants of BMI and common complex obesity, along with associated depression symptoms and smoking behavior.

L'évaluation des données de sécurité du médicament reste encore limitée dans les pays en voie de développement. La création du Centre National de Pharmacovigilance du Vietnam en 2009 a permis l'enregistrement des notifications spontanées d'effets indésirables (EIs) permettant une analyse quantitative et qualitative et de générer des éventuels signaux de pharmacovigilance. Les objectifs principaux de la thèse étaient : (i) décrire le système de pharmacovigilance vietnamien, et comparer les données à travers quelques exemples, au système de pharmacovigilance français, (ii) appliquer un ensemble d'approches pharmaco-épidémiologiques pour identifier les risques médicamenteux au Vietnam et (iii) améliorer la sous-notification des EIs. Nous introduisons pour la première fois, un bilan complet du système de pharmacovigilance vietnamien avec une série de suggestions pour les pays partageant le même contexte de ressources limitées. Quelques résultats et défis pour le développement durable du système ont également été discutés. Secondairement, nous avons utilisé les bases de données de pharmacovigilance vietnamienne et française pour comparer le profil de notification pour 2 types d'EIs : anaphylaxie et syndrome de Steven-Johnson et nécrolyse épidermique toxique (SSJ/NET) d'origine médicamenteuse. Nous avons généré les premiers signaux de pharmacovigilance vietnamienne : l'allopurinol, la carbamazépine, les médicaments traditionnels, la colchicine, l'acide valproïque et le méloxicam ont généré des signaux pour le SSJ/NET - déjà connus dans littérature. Par ailleurs, nous avons retrouvé des signaux significatifs pour le cefixime et le paracétamol. Pour l'anaphylaxie, nous avons identifié 4873 (13.2%) cas dans la base vietnamienne pendant la période 2010-2016 avec une tendance à l'augmentation au cours du temps. Les antibiotiques (notamment céphalosporines de 3ème génération) sont les causes principales de l'anaphylaxie médicamenteuse au Vietnam. De plus, des signaux pour certains médicaments comme l'alpha-chymotrypsine, l'amoxicilline/sulbactame et les solutions de glucose ou électrolytes peuvent être typiques pour les pays en voie de développement. Enfin, l'identification des EIs à partir des données de laboratoire de biologie de l'hôpital pourrait améliorer le taux de notification d'EI au Vietnam. [...] / The understanding and quantitative analysis in drug safety domain among developing countries remain still limited. The creation of the National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) of Vietnam in 2009 was a landmark for the pharmacovigilance activities in this country and allowed the registration of spontaneous adverse drug reaction (ADR) reports. The accumulation of National Pharmacovigilance Database of Vietnam (NPDV) requires a quantitative and qualitative analysis and generation of pharmacovigilance signals to better protect Vietnamese people's health. The main objectives of the thesis are: (i) describe the Vietnamese pharmacovigilance system, with the comparison to another developed pharmacovigilance system as a reference (France), (ii) apply a set of pharmacoepidemiological approaches to identify the specific drug-related risks, and (iii) improve the under-reporting issue in Vietnam. Firstly, we introduce a full-detailed overview of Vietnamese pharmacovigilance system with a series of lessons learned for the other countries sharing the similar limited-resource context. Some achievements and challenges for the sustainable development of the system were also equitably discussed. Secondly, we used the Vietnamese and French pharmacovigilance databases to compare the differences in characteristics of two types of ADR: anaphylaxis and Steven-Johnson's syndrome and toxic epidermal necrolysis (SJS/TEN) induced by medications. Next, we generated the first Vietnamese pharmacovigilance signals. The signals of drug-induced SJS/TEN were generated with allopurinol, carbamazepine, traditional or herbal drugs, colchicine, valproic acid and meloxicam which were similar to the other previously studies in literature. Furthermore, we also found the significant signals of cefixime and paracetamol. For drug-induced anaphylaxis, we identified 4873 (13.2%) cases in the Vietnamese database during the period 2010-2016 with an increasing trend over time. The antibiotics (especially the third-generation cephalosporins) were the main causes of drug-induced anaphylaxis in Vietnam. In addition, the signals were generated with several drugs such as alpha-chymotrypsin, amoxicillin/sulbactam and glucose or electrolyte solutions which were typical for the resource-restricted countries. On the other hand, the identification of ADR through the screening the laboratory test results could help to increase the ADR reporting rate in Vietnam. [...]