Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

A Research Roadmap for Complementary and Alternative Medicine – What We Need to Know by 2020

Background: The CAMbrella coordination action was funded within the Framework Programme 7. Its aim is to provide a research roadmap for clinical and epidemiological research for complementary and alternative medicine (CAM) that is appropriate for the health needs of European citizens and acceptable to their national research institutes and healthcare providers in both public and private sectors. One major issue in the European research agenda is the demographic change and its impact on health care. Our vision for 2020 is that there is an evidence base that enables European citizens to make informed decisions about CAM, both positive and negative. This roadmap proposes a strategic research agenda for the field of CAM designed to address future European health care challenges. This roadmap is based on the results of CAMbrella’s several work packages, literature reviews and expert discussions including a consensus meeting. Methods: We first conducted a systematic literature review on key issues in clinical and epidemiological research in CAM to identify the general concepts, methods and the strengths and weaknesses of current CAM research. These findings were discussed in a workshop (Castellaro, Italy, September 7–9th 2011) with international CAM experts and strategic and methodological recommendations were defined in order to improve the rigor and relevance of CAM research. These recommendations provide the basis for the research roadmap, which was subsequently discussed in a consensus conference (Järna, Sweden, May 9–11th 2012) with all CAMbrella members and the CAMbrella advisory board. The roadmap was revised after this discussion in CAMbrella Work Package (WP) 7 and finally approved by CAMbrella’s scientific steering committee on September 26th 2012. Results: Our main findings show that CAM is very heterogenous in terms of definitions and legal regulations between the European countries. In addition, citizens’ needs and attitudes towards CAM as well as the use and provision of CAM differ significantly between countries. In terms of research methodology, there was consensus that CAM researchers should make use of all the commonly accepted scientific research methods and employ those with utmost diligence combined in a mixed methods framework. Conclusions: We propose 6 core areas of research that should be investigated to achieve a robust knowledge base and to allow stakeholders to make informed decisions. These are: Research into the prevalence of CAM in Europe: Reviews show that we do not know enough about the circumstances in which CAM is used by Europeans. To enable a common European strategic approach, a clear picture of current use is of the utmost importance. Research into differences regarding citizens’ attitudes and needs towards CAM: Citizens are the driver for CAM utilization. Their needs and views on CAM are a key priority, and their interests must be investigated and addressed in future CAM research. Research into safety of CAM: Safety is a key issue for European citizens. CAM is considered safe, but reliable data is scarce although urgently needed in order to assess the risk and cost-benefit ratio of CAM. Research into the comparative effectiveness of CAM: Everybody needs to know in what situation CAM is a reasonable choice. Therefore, we recommend a clear emphasis on concurrent evaluation of the overall effectiveness of CAM as an additional or alternative treatment strategy in real-world settings. Research into effects of context and meaning: The impact of effects of context and meaning on the outcome of CAM treatments must be investigated; it is likely that they are significant. Research into different models of CAM health care integration: There are different models of CAM being integrated into conventional medicine throughout Europe, each with their respective strengths and limitations. These models should be described and concurrently evaluated; innovative models of CAM provision in health care systems should be one focus for CAM research. We also propose a methodological framework for CAM research. We consider that a framework of mixed methodological approaches is likely to yield the most useful information. In this model, all available research strategies including comparative effectiveness research utilising quantitative and qualitative methods should be considered to enable us to secure the greatest density of knowledge possible. Stakeholders, such as citizens, patients and providers, should be involved in every stage of developing the specific and relevant research questions, study design and the assurance of real-world relevance for the research. Furthermore, structural and sufficient financial support for research into CAM is needed to strengthen CAM research capacity if we wish to understand why it remains so popular within the EU. In order to consider employing CAM as part of the solution to the health care, health creation and self-care challenges we face by 2020, it is vital to obtain a robust picture of CAM use and reliable information about its cost, safety and effectiveness in real-world settings. We need to consider the availability, accessibility and affordability of CAM. We need to engage in research excellence and utilise comparative effectiveness approaches and mixed methods to obtain this data. Our recommendations are both strategic and methodological. They are presented for the consideration of researchers and funders while being designed to answer the important and implicit questions posed by EU citizens currently using CAM in apparently increasing numbers. We propose that the EU actively supports an EUwide strategic approach that facilitates the development of CAM research. This could be achieved in the first instance through funding a European CAM coordinating research office dedicated to foster systematic communication between EU governments, public, charitable and industry funders as well as researchers, citizens and other stakeholders. The aim of this office would be to coordinate research strategy developments and research funding opportunities, as well as to document and disseminate international research activities in this field. With the aim to develop sustainability as second step, a European Centre for CAM should be established that takes over the monitoring and further development of a coordinated research strategy for CAM, as well as it should have funds that can be awarded to foster high quality and robust independent research with a focus on citizens health needs and pan-European collaboration. We wish to establish a solid funding for CAM research to adequately inform health care and health creation decision-making throughout the EU. This centre would ensure that our vision of a common, strategic and scientifically rigorous approach to CAM research becomes our legacy and Europe’s reality. We are confident that our recommendations will serve these essential goals for EU citizens.

Lessons from Ellen: A Case Study Investigation of Comprehension Strategy Instruction in Action

In the past ten years, reading comprehension instruction has received significant attention from educational researchers. Drawing on studies from cognitive psychology, reader response theory, and language arts research, current best practice in reading comprehension instruction is characterized by a strategies approach in which students are taught to think like proficient readers who visualize, infer, activate schema, question, and summarize as they read. Studies investigating the impact of comprehension strategy instruction on student achievement in reading suggest that when implemented consistently the intervention has a positive effect on achievement. Research also shows, however, that few teachers embrace this approach to reading instruction despite its effectiveness, even when the conditions for substantive professional development (i.e. prolonged engagement, support, resources, time) are present. The interpretive case study reported in this dissertation examined the year-long experience of one fourth grade teacher, Ellen, as she leanled about comprehension strategy instruction and attempted to integrate the approach in her reading program. The goal of the study was to extend current understanding of the factors that support or inhibit an individual teacher's instructional decision making. The research explored how Ellen's academic preparation, beliefs about reading comprehension instruction, and attitudes toward teacher-student interaction influenced her efforts to employ comprehension strategy instruction. Qualitative methods were the basis of this study's research design. The primary methods for collecting data included pre- and post-interviews, field notes from classroom observations and staff development sessions, infonnal interviews, e-mail correspondence, and artifacts such as reading assignments, professional writing, school newsletters, and photographs of the classroom. Transcripts from interviews, as well as field notes, e-mail, and artifacts, were analyzed according to grounded theory's constant-comparative method. The results of the study suggest that three factors were pivotal in Ellen's successful implementation of reading strategy instruction: Pedagogical beliefs, classroom relationships, and professional community. Research on instructional change generally focuses on issues of time, resources, feedback, and follow-through. The research reported here recognizes the importance of these components, but expands contemporary thinking by showing how, in Ellen's case, a teacher's existing theories, her relationship with her students, and her professional interaction with peers impact instructional decisions.

Perspective transformation: Women in long-term recovery from alcohol abuse

Objective. The purpose of this study was to determine the meaning of personal transformation for twenty women in long term, stable recovery from alcohol abuse; to identify themes or patterns of this recovery, and; to determine the extent to which they experienced the phenomenon of perspective transformation. ^ Method. Volunteers were recruited by advertisement, word of mouth, and through a closed circuit web based broadcast. A descriptive, exploratory study, which analyzed perspective transformation from the standpoint of five action phases, was conducted. Data was collected using in-depth personal interviews and questionnaires. Subjects' responses were analyzed by qualitative methods. Triangulation was performed on the grouped data comparing the interviews to the data produced by the questionnaires. Quantitative analysis of questionnaire items explored behavioral changes experienced before and after alcoholism recovery. ^ Results. Five phases of recovery were identified. Phase I which involved recognition that alcohol was a problem and change might be possible took several years during which 3 major transitions occurred: (1) from often being alienated to having relationships with family and friends; (2) from daily upheavals to eventually a more peaceful existence, and; (3) from denial that alcohol was a problem to acceptance and willingness to change. Recovery was often seen in a spiritual context, which also required ongoing support. During Phase II there was an assessment of self, others, and the environment which revealed a pattern of intense unhappiness and negative feelings toward self and others with a disregard for cultural norms. Phase III revealed a period of desperation as life became unmanageable, but gradual willingness to accept support and guidance and a desire to improve self and help others. This led to improvement of existing role performance and the willingness to try out new roles. In Phase IV there was a pattern of personal growth which included: the establishment of boundaries, setting priorities, a willingness to place others' needs above their own, acceptance of responsibility, and learning to cope without alcohol, often with the use of tools learned in AA. During Phase V, many experienced knowledge of frailties but growing respect for self and others, with an improved ability to function in giving relationships. Implications for Prevention and Recovery: Early education concerning addiction and recovery may play a crucial role in prevention and early recovery, as it did for children of women in this study. Recovery requires persistent effort and organized support. ^

Evaluation of the March of Dimes Family Support Program with Focus on Parent to Parent Support

The March of Dimes NICU Family Support Program provides families with support specialists, educational materials, and community resources to aide in the emotional and physical adaptation to a new life with a premature infant. Parent-to-parent support has been shown to more effective than group support because the new NICU parent is able to connect on a more personal level with an experienced NICU parent. The purpose of the research was to develop and implement an evaluation instrument to assess the effectiveness of the March of Dimes NICU Family Support Program (MODFSP) in the NICU at the UConn Health Center, specifically parent-to-parent support. Steps involved in the process included determining areas of focus for the instrument, developing items based on MODFSP materials and literature review, piloting the materials on parents with infants in the NICU (with IRB approval), and utilizing descriptive statistics through SPSS Version 14 to assess the results from the instrument content. Qualitative items were also included in the evaluation, and descriptive qualitative methods, as appropriate, were used to analyze those items. The findings have supported the literature in that all parents that participated in parent to parent support agreed the program was beneficial in assisting them with their transition to life with a premature infant. In addition to evaluating the new NICU parent’s opinions of the program, researchers evaluated the staff and volunteer parents that were involved in the program. The results also revealed that the new NICU parent’s fear, anxiety, and stress decreased after the parent-to-parent interactions. The preliminary results were encouraging that the MODFSP has implemented an effective parent-to-parent support program to support parents through their time of crisis.

Health, education and community: Assets and needs of a small urban community in north east Tamaulipas, Mexico: A community based participatory research assessment

This study explored the health, education, social assets, needs, attitudes, and behaviors of residents of Ferrocarril #4, a small urban community in Tamaulipas, Mexico. A collaborative Participatory Action Research approach was used to emphasize community involvement. Using Triangulation to ensure validity, qualitative methods included key informant in depth interviews, participant observation and participatory discussion groups with women and men. A personal interview with a probability sample of women was done. The median age of interviewees was 37 years. The majority was married or had a partner. Over half of respondents completed grades 6-9. Employed women (25%) earned a median weekly salary equivalent to ∼56 USD. Women with health insurance (67.7%) were covered mainly through Social Security and Seguro Popular. One in 5 reported bad health. Barriers to care were primarily money and transportation. To improve health care, women wanted a full service clinic in or close to the community and affordable health care. Socially, 28% of respondents had no close friends in the community and most did not participate in beneficial community activities. Many women did not socialize with others and help from neighbors was situational. Primary school teachers lacked parental support and it interfered with classroom efforts. Healthy community discussion groups focused on personal and environmental hygiene and safety. Valuable assets exist in the community. To date, collaborative efforts resulted in a school First Aid station, a school nurse visit weekly, posting of emergency contact phone numbers in the school and community center, and development of a student health information form. ^

Latino perceptions of and barriers to preventive healthcare maintenance in the southwest United States

Between the 1990 and 2000 Censuses, the Latino population accounted for 40% of the increase in the nation’s total population. The growing population of Latinos underscores the importance for understanding factors that influence whether and how Latinos take care of their health. According to the U.S. Department of Human Health Service’s Office of Minority Health (OMH), Latinos are at greater risk for health disparities (2003). Factors such as lack of health insurance and access to preventive care play a major role in limiting Latino use of primary health care (Institute of Medicine, 2005). Other significant barriers to preventive health care maintenance behaviors have been identified in current literature such as primary care physician interaction, self-perceived health status, and socio-cultural beliefs and traditions (Rojas-Guyler, King, Montieth and 2008; Meir, Medina, and Ory, 2007; Black, 1999). Despite these studies, there remains less information regarding interpersonal perceptions, environmental dynamics and individual and cultural attitudes relevant to utilization of healthcare (Rojas-Guyler, King, Montieth and 2008; Aguirre-Molina, Molina and Zambrana, 2001). Understanding the perceptions of Latinos and the barriers to health care could directly affect healthcare delivery. Improved healthcare utilization among Latinos could reduce the long term health consequences of many preventable and manageable diseases. The purpose of this study was to explore Latino perceptions of U.S. health care and desired changes by Latinos in the U.S. healthcare system. The study had several objectives, including to explore perceived barriers to healthcare utilization and the resulting effects on health among Latinos, to describe culturally influenced attitudes about health care and use of health care services among Latinos, and to make recommendations for reducing disparities by improving healthcare and its utilization. The current study utilized data that were collected as part of a larger study to examine multidimensional, cross-cultural issues relevant to interactions between healthcare consumers and providers. Qualitative methods were used to analyze four Spanish-language focus group transcripts to interpret cultural influences on perceptions and beliefs among Latinos. Direct coding of transcript content was carried out by two reviewers, who conducted independent reviews of each transcript. Team members developed and refined thematic categories, positive and negative cases, and example text segments for each theme and sub-theme. Incongruities of interpretations were resolved through extensive discussion. Study participants included 44 self-identified Latino adults (16 male, 28 female) between age 18 and 64 years. Thirty seven (84.1%) of the participants were immigrants. The study population comprised eight ethnic subgroups. While 31% of the participants reported being employed on a full-time basis, only 18.4% had medical insurance that was private or employee sponsored. Five major themes regarding the perceptions and healthcare utilization behaviors of Latinos were consistent across all focus groups and were identified during the analysis. These were: (1) healthcare utilization, experience, and access; (2) organizational and institutional systems; (3) communication and interpersonal interactions between healthcare provider, staff, and patient; (4) Latinos’ perception of their own health status; (5) cultural influences on healthcare utilization, which included an innovation termed culturally-bound locus of control. Healthcare utilization was directly influenced by healthcare experience, access, current health status, and cultural factors and indirectly influenced by organizational systems. There was a strong interdependence among the main themes. The ability to communicate and interact effectively with healthcare providers and navigate healthcare systems (organizational and institutional access) significantly influenced the participant’s health care experience, most often (indirectly) impacting utilization negatively. ^ Research such as this can help to identify those perceptions and attitudes held by Latinos concerning utilization or underutilization of healthcare systems. These data suggest that for healthcare utilization to improve among Latinos, healthcare systems must create more culturally competent environments by providing better language services at the organizational level and more culturally sensitive providers at the interpersonal level. Better understanding of the complex interactions between these impediments can aid intervention developments, and help health providers and researchers in determining appropriate, adequate, and effective measurers of care to better increase overall health of Latinos.^

African American and Hispanic adolescent STI and pregnancy prevention: Whose responsibility is it, anyway?

This dissertation utilized quantitative and qualitative methods to examine the role of responsibility in the prevention of sexually transmitted infections (STIs) and pregnancy through condom use and other sexual behaviors among young adolescents. Data were analyzed across race and gender and three papers were developed. The quantitative portion used logistic regression to assess associations between personal responsibility, as well as other know correlates, and reported condom use and condom use intentions as a means of STI and pregnancy prevention among 445 inner-city, high school adolescents. Responsibility to prevent pregnancy by providing the condom was associated with condom use at last sex and consistent condom use. Responsibility to prevent acquiring a STI by using a condom was significantly associated with consistent condom use. No significant associations were found between responsibility and condom use intentions. ^ The qualitative section of the dissertation project involved conducting 28 in-depth interviews among 9th and 10th grade, African American and Hispanic students who attended a large urban school district in South Central Texas. Perceptions of responsibility for preventing STIs and unintended pregnancy, as well as for condom use, were explored. Male and female adolescents expressed joint responsibility to prevent a STI or pregnancy. Perceptions of responsibility for providing and using the condoms were mixed. Despite the indication of both partners, mostly all participants implied that females, more so than the males, had the final responsibility to prevent contracting a STI, a pregnancy, to provide a condom, and to make sure a condom was used. Participants expressed the role of parents' involvement for preventing these outcomes as well as the need for more sexual health education and access to preventative methods. ^ The last section of this dissertation involved qualitative inquiry to ascertain perceptions of reasons why adolescents engage in anal and oral (non-coital) sex. Pleasure-seeking and giving as well social influence and pressure were described as the main reasons why teenagers have non-coital sex. Other reasons included conveniences of participating in these behaviors such as ease of performing oral sex and anal sex as a convenient alternative to vaginal sex. Sexual inexperience was an indicator for why anal sex occurs. Many of the reasons involved misperceptions and adolescents who practice these sexual behaviors place themselves at-risk for contracting a STI. ^ This dissertation increased the current knowledge base about adolescent sexual responsibility and non-coital behaviors. Future studies should explore perceptions of responsibility and actual sexual activity practices among adolescents to reduce the burden of STIs and pregnancy as well as help public health professionals develop programs for adolescent populations, schools, and communities where these issues persist.^

Exploring parental factors and their influence on early adolescent sexual health

Black and Hispanic youth experience the largest burden of sexually transmitted infections, teen pregnancy, and childbirth (Hamilton, Martin, & Ventura, 2011). Minority youth are disporportionately more likely to sexually debut at every age and debut before the age of 13 compared to whites (Centers for Disease Control and Prevention, 2011). However, there is little known about pre-coital sexual activity or protective parental factors in early adolscent minority youth. Parental factors such as parent-child communication and parental monitoring influence adolescent sexual behaviors and pre-coital sexual behaviors in early adolescence. Three distinct methods were used in this dissertation. Study one used qualitative methods, semi-structured, in-depth, individual interviews, to explore parent-child communication in African American mother-early adolescent son dyads. Study two used quantitative methods, secondary data analysis of a cross sectional study, to conduct a moderation analysis. For study three, I conducted a systematic review of parent-based adolescent sexual health interventions. Study one found that mothers feel comfortable talking about sex with adolescents, provide a two-prong sexual health message, and want their sons to tell their when they are thinking of having sex. Study found that parental monitoring moderates the relation between parent-child communication and pre-coital sexual behaviors. Study three found that interventions use a variety of theory, methods, and strategies and that no parent-based programs target faith-based organizations, mother-son or father-daughter dyads, or parents of LGBTQ youth. Adolescent sexual health interventions should consider addressing youth-to-parent disclosure of sexual activity or intentions to debut, addressing both parent-child sexual health communication and parental monitoring, and using a theoretical framework.^

Jóvenes y políticas públicas de terminalidad educativa : un estudio sobre capital social y estrategias de vida

Desde una perspectiva teórica centrada en el relacionismo, el presente artículo tiene como objetivo abordar las relaciones entre capital social y estrategias de vida. Específicamente, nos preguntamos por la construcción de redes sociales en el trabajo y en la educación y las formas de intervención en las estrategias de vida de jóvenes que se encuentran estudiando en el Plan FinEs2. Retomamos una perspectiva metodológica cualitativa y realizamos entrevistas en profundidad a jóvenes estudiantes y trabajadores de un barrio del Gran La Plata durante el periodo 2012-2013. Finalmente, sostenemos que la experiencia del Plan FinEs2 posibilita la construcción de nuevas redes sociales -colectivas e individuales desplegadas en las estrategias de vida que los jóvenes estudiantes desarrollan.

Impactos de la modernización en los chacareros frutícolas del Alto Valle rionegrino

El objetivo del este trabajo es conocer los comportamientos productivos de los chacareros frutícolas, de cara a la modernización diferencial de la actividad. La estrategia metodológica propone un diseño de tipo estructurado, con triangulación de métodos cuanti y cualitativos, sobre una muestra selectiva de productores familiares de la localidad de Allen. El estudio revela que frente a los crecientes requerimientos de calidad y sanidad para la comercialización, emergen una nueva heterogeneización de las posiciones estructurales de los productores familiares capitalizados, con marcada vinculación a los comportamientos laborales familiares complementarios/suplementarios y connotaciones para sus senderos de reproducción social

El tratamiento de los estudios de caso como herramienta de investigación : Su aporte en el subcampo de las Relaciones Internacionales

Este artículo revisa el papel clave que los métodos de estudio de casos han jugado en el estudio de las relaciones internacionales, especialmente en los estudios de Estados Unidos. Los estudios de caso en el subcampo de Relaciones Internacionales no son los estudios inconexos, a-teóricos e ideográficos que sus críticos censuran. Estos forman un conjunto cada vez más estandarizado y riguroso y, junto con el trabajo estadístico y formal, han contribuido a mejorar de forma acumulativa el entendimiento de la política mundial. El artículo analiza y revisa ejemplos de criterios de selección de casos (incluyendo los menos probables, menos y más similares y los casos desviados); la innovación conceptual; teorías tipológicas, tipologías explicativas, el análisis comparativo cualitativo y el análisis de conjuntos difusos; el proceso de rastreo, y la integración de múltiples métodos

Impactos de la modernización en los chacareros frutícolas del Alto Valle rionegrino

El objetivo del este trabajo es conocer los comportamientos productivos de los chacareros frutícolas, de cara a la modernización diferencial de la actividad. La estrategia metodológica propone un diseño de tipo estructurado, con triangulación de métodos cuanti y cualitativos, sobre una muestra selectiva de productores familiares de la localidad de Allen. El estudio revela que frente a los crecientes requerimientos de calidad y sanidad para la comercialización, emergen una nueva heterogeneización de las posiciones estructurales de los productores familiares capitalizados, con marcada vinculación a los comportamientos laborales familiares complementarios/suplementarios y connotaciones para sus senderos de reproducción social

El tratamiento de los estudios de caso como herramienta de investigación : Su aporte en el subcampo de las Relaciones Internacionales

Este artículo revisa el papel clave que los métodos de estudio de casos han jugado en el estudio de las relaciones internacionales, especialmente en los estudios de Estados Unidos. Los estudios de caso en el subcampo de Relaciones Internacionales no son los estudios inconexos, a-teóricos e ideográficos que sus críticos censuran. Estos forman un conjunto cada vez más estandarizado y riguroso y, junto con el trabajo estadístico y formal, han contribuido a mejorar de forma acumulativa el entendimiento de la política mundial. El artículo analiza y revisa ejemplos de criterios de selección de casos (incluyendo los menos probables, menos y más similares y los casos desviados); la innovación conceptual; teorías tipológicas, tipologías explicativas, el análisis comparativo cualitativo y el análisis de conjuntos difusos; el proceso de rastreo, y la integración de múltiples métodos