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. ^

Disparities in medical expenditure and utilization among hypertensive men and women in the U.S.: Cross-section and lifetime analysis

Objectives. To investigate procedural gender equity by assessing predisposing, enabling and need predictors of gender differences in annual medical expenditures and utilization among hypertensive individuals in the U.S. Also, to estimate and compare lifetime medical expenditures among hypertensive men and women in the U.S. ^ Data source. 2001-2004 the Medical Expenditure Panel Survey (MEPS);1986-2000 National Health Interview Survey (NHIS) and National Health Interview Survey linked to mortality in the National Death Index through 2002 (2002 NHIS-NDI). ^ Study design. We estimated total medical expenditure using four equations regression model, specific medical expenditures using two equations regression model and utilization using negative binomial regression model. Procedural equity was assessed by applying the Aday et al. theoretical framework. Expenditures were estimated in 2004 dollars. We estimated hypertension-attributable medical expenditure and utilization among men and women. ^ To estimate lifetime expenditures from ages 20 to 85+, we estimated medical expenditures with cross-sectional data and survival with prospective data. The four equations regression model were used to estimate average annual medical expenditures defined as sum of inpatient stay, emergency room visits, outpatient visits, office based visits, and prescription drugs expenditures. Life tables were used to estimate the distribution of life time medical expenditures for hypertensive men and women at different age and factors such as disease incidence, medical technology and health care cost were assumed to be fixed. Both total and hypertension attributable expenditures among men and women were estimated. ^ Data collection. We used the 2001-2004 MEPS household component and medical condition files; the NHIS person and condition files from 1986-1996 and 1997-2000 sample adult files were used; and the 1986-2000 NHIS that were linked to mortality in the 2002 NHIS-NDI. ^ Principal findings. Hypertensive men had significantly less utilization for most measures after controlling predisposing, enabling and need factors than hypertensive women. Similarly, hypertensive men had less prescription drug (-9.3%), office based (-7.2%) and total medical (-4.5%) expenditures than hypertensive women. However, men had more hypertension-attributable medical expenditures and utilization than women. ^ Expected total lifetime expenditure for average life table individuals at age 20, was $188,300 for hypertensive men and $254,910 for hypertensive women. But the lifetime expenditure that could be attributed to hypertension was $88,033 for men and $40,960 for women. ^ Conclusion. Hypertensive women had more utilization and expenditure for most measures than hypertensive men, possibly indicating procedural inequity. However, relatively higher hypertension-attributable health care of men shows more utilization of resources to treat hypertension related diseases among men than women. Similar results were reported in lifetime analyses.^ Key words: gender, medical expenditures, utilization, hypertension-attributable, lifetime expenditure ^

Impact of a modified dietary plan on the health related quality of life of minority participants in the Women's Healthy Eating and Living (WHEL) Study

Advances in medical technology, in genetics, and in clinical research have led to early detection of cancer, precise diagnosis, and effective treatment modalities. Decline in cancer incidence and mortality due to cancer has led to increased number of long-term survivors. However, the ethnic minority population has not experienced this decline and still continues to carry a disparate proportion of the cancer burden. Majority of the clinical research including survivorship studies have recruited and continue to recruit a convenient sample of middle- to upper-class Caucasian survivors. Thus, minorities are underrepresented in cancer research in terms of both clinical studies and in health related quality of life (HRQOL) studies. ^ Life style and diet have been associated with increased risk of breast cancer. High vegetable low fat diet has been shown to reduce recurrence of breast cancer and early death. The Women's Healthy Eating and Living Study is an ongoing multi-site randomized controlled trial that is evaluating the high-vegetable low fat diet in reducing the recurrence of breast cancer and early death. The purpose of this dissertation was to (1) compare the impact of the modified diet on the HRQOL during the first 12-month period on specific Minorities and matched Caucasians; (2) identify predictors that significantly impact the HRQOL of the study participants; and (3) using the structural equation modeling assess the impact of nutrition on the HRQOL of the intervention group participants. Findings suggest that there are no significant differences in change in HRQOL between Minorities and Caucasians; between Minorities in the intervention group and those in the comparison group; and between women in the intervention group and those in the comparison group. Minority indicator variable and Intervention/Comparison group indicator variable were not found to be good predictors of HRQOL. Although the structural equation models suggested viable representation of the relationship between the antecedent variables, the mediating variables and the two outcome variables, the impact of nutrition was not statistically significant to be included in the model. This dissertation, by analyzing the HRQOL of minorities in the WHEL Study, attempted to add to the knowledge base specific to minority cancer survivors. ^

Spirituality of Thai Buddhists with chronic cardiovascular disease

Background. Advances in medical technology contribute to the survival rate of a growing number of persons with chronic illnesses. Individuals with chronic cardiovascular disease (chronic CVD) are among other chronically ill persons who add to the need for healthcare services. They need to cope and live with the chronic conditions and find a new balance to make sense of their lives. Thai Buddhists with chronic CVD may use their religious resources to cope with their illnesses because religious beliefs are reflected in patterns of living. The aims of the study were to: (a) explore how Thai Buddhists with chronic CVD construct the spiritual aspects of the illness experience, (b) explore how Thai Buddhists with chronic CVD may use their spiritual/religious resources as a means of coping with the illness, and (c) explore the impacts of spiritual/religious beliefs and/or practices on the daily lives of Thai Buddhists with chronic CVD. ^ Methods. Ethnography was employed and data were collected from December 1, 2007 to May 31, 2008 using in-depth interviews with 20 participants. Field notes were also recorded. ^ Findings. Three categories emerged from the study data: set of spiritual and biomedical beliefs and practices, integrated meanings, and positive consequences of the integration of spiritual and biomedical beliefs and practices. ^ Conclusions. The findings of the study suggest the importance of understanding and integrating spiritual needs into care of patients with chronic CVD. The findings revealed that the participants constructed ideas of their illness and meanings for living and coping with the illness, and integrated spiritual and biomedical beliefs and practices, resulting in positive outcomes. Further research could test interventions which facilitate such coping; for example, using reflective thinking and group support. Other studies might explore how age affects Buddhist views of the illness. ^

Using technology to teach technology: design and evaluation of bilingual online physician education about electronic medical records.

The "EMR Tutorial" is designed to be a bilingual online physician education environment about electronic medical records. After iterative assessment and redesign, the tutorial was tested in two groups: U.S. physicians and Mexican medical students. Split-plot ANOVA revealed significantly different pre-test scores in the two groups, significant cognitive gains for the two groups overall, and no significant difference in the gains made by the two groups. Users rated the module positively on a satisfaction questionnaire.

Patient-centered medical home technology effects on hypertension and diabetes control

Background: Hypertension and Diabetes is a public health and economic concern in the United States. The utilization of medical home concepts increases the receipt of preventive services, however, do they also increase adherence to treatments? This study examined the effect of patient-centered medical home technologies such as the electronic health record, clinical support system, and web-based care management in improving health outcomes related to hypertension and diabetes. Methods: A systematic review of the literature used a best evidence synthesis approach to address the general question " Do patient-centered medical home technologies have an effect of diabetes and hypertension treatment?" This was followed by an evaluation of specific examples of the technologies utilized such as computer-assisted recommendations and web-based care management provided by the patient's electronic health record. Ebsco host, Ovid host, and Google Scholar were the databases used to conduct the literature search. Results: The initial search identified over 25 studies based on content and quality that implemented technology interventions to improve communication between provider and patient. After further assessing the articles for risk of bias and study design, 13 randomized controlled studies were chosen. All of the studies chosen were conducted in various primary care settings in both private practices and hospitals between the years 2000 and 2007. The sample sizes of the studies ranged from 42 to 2924 participants. The mean age for all of the studies ranged from 56 to 71 years. The percent women in the studies ranged from one to 78 percent. Over one-third of the studies did not provide the racial composition of the participants. For the seven studies that did provide information about the ethnic composition, 64% of the intervention participants were White. All of the studies utilized some type of web-based or computer-based communication to manage hypertension or diabetes care. Findings on outcomes were mixed, with nine out of 13 studies showing no significant effect on outcomes examined, and four of the studies showing significant and positive impact on health outcomes related to hypertension or diabetes Conclusion: Although the technologies improved patient and provider satisfaction, the outcomes measures such as blood pressure control and glucose control were inconclusive. Further research is needed with diverse ethnic and SES population to investigate the role of patient-centered technologies on hypertension and diabetes control. Also, further research is needed to investigate the effects of innovative medical home technologies that can be used by both patients and providers to increase quality of communication concerning adherence to treatments.^

An Interdisciplinary Approach to a Dental Information Technology Course

Purpose: To develop an interdisciplinary course to teach dental students about evidence-based dentistry, development of search strategies, critical appraisal of literature, and dental informatics. [See PDF for complete abstract]

Smart Classrooms: Guidelines for Educational Technology in Classroom Facility in The University of Texas System

Problem Statement: Classroom facilities developed as new construction or renovation projects for UT System institutions tend to be developed as individual, ad hoc project. There are significant opportunities for process improvement is establishing standard business processes for developing Smart Classroom, establishing design standards and referring to prototype facilities developed at other institutions. [See PDF for complete abstract]

Role of technology: Podcast in influencing respondents to receive a flu shot

Background and Problem: Studies have demonstrated that flu shots are an effective method to control flu infection. However, statistics reveal that only about 68% of people get vaccinated in the U.S. every year. We wanted to develop and evaluate an intervention to increase influenza vaccination rate. [See PDF for complete abstract]

Educational Technology-Benefits and Barriers

Statement of Problem: The second background paper for the Medical School Objective Project (MSOP), defined Educational Technology (ET) as the use of information technology to facilitate student’s learning.1 Medical schools as a group have made limited progress in accomplishing the recommended educational technology goals and there had been much greater use of such technology in basic sciences courses than in clinical clerkships. We will explore the positive and negative implications of incorporating ET into the educational experience of TMC schools. [See PDF for complete abstract]

An Emerging Technology: To Model Patient Education for the Dental Hygiene Student

Introduction: Could Livestream Video, an emerging audiovisual media, be used more effectively than the traditional demonstration method of teaching or modeling dental hygiene students on how to provide chairside patient education? [See PDF for complete abstract]

Comparing communication technology on Chinese, English, and Spanish diabetes web sites.

Technological and cultural factors influence access to health information on the web in multifarious ways. We evaluated structural differences and availability of communication services on the web in three diverse language and cultural groups: Chinese, English, and Spanish. A total of 382 web sites were analyzed: 144 were English language sites (38%), 129 were Chinese language sites (34%), and 108 were Spanish language sites (28%). We did not find technical differences in the number of outgoing links per domain or the total availability of communication services between the three groups. There were differences in the distribution of available services between Chinese and English sites. In the Chinese sites, there were more communication services between consumers and health experts. Our results suggest that the health-related web presence of these three cultural groups is technologically comparable, but reflects differences that may be attributable to cultural factors.

Application of Signal Advance Technology to Electrophysiology

Medical instrumentation used in diagnosis and treatment relies on the accurate detection and processing of various physiological events and signals. While signal detection technology has improved greatly in recent years, there remain inherent delays in signal detection/ processing. These delays may have significant negative clinical consequences during various pathophysiological events. Reducing or eliminating such delays would increase the ability to provide successful early intervention in certain disorders thereby increasing the efficacy of treatment. In recent years, a physical phenomenon referred to as Negative Group Delay (NGD), demonstrated in simple electronic circuits, has been shown to temporally advance the detection of analog waveforms. Specifically, the output is temporally advanced relative to the input, as the time delay through the circuit is negative. The circuit output precedes the complete detection of the input signal. This process is referred to as signal advance (SA) detection. An SA circuit model incorporating NGD was designed, developed and tested. It imparts a constant temporal signal advance over a pre-specified spectral range in which the output is almost identical to the input signal (i.e., it has minimal distortion). Certain human patho-electrophysiological events are good candidates for the application of temporally-advanced waveform detection. SA technology has potential in early arrhythmia and epileptic seizure detection and intervention. Demonstrating reliable and consistent temporally advanced detection of electrophysiological waveforms may enable intervention with a pathological event (much) earlier than previously possible. SA detection could also be used to improve the performance of neural computer interfaces, neurotherapy applications, radiation therapy and imaging. In this study, the performance of a single-stage SA circuit model on a variety of constructed input signals, and human ECGs is investigated. The data obtained is used to quantify and characterize the temporal advances and circuit gain, as well as distortions in the output waveforms relative to their inputs. This project combines elements of physics, engineering, signal processing, statistics and electrophysiology. Its success has important consequences for the development of novel interventional methodologies in cardiology and neurophysiology as well as significant potential in a broader range of both biomedical and non-biomedical areas of application.

PANEL DISCUSSION: "Medical Ethics, Eugenics, and the Holocaust"

A panel discussion moderated by Dr. Thomas R. Cole, McGovern Chair in Medical Humanities and Director of the John P. McGovern Center for Humanities and Ethics at the University of Texas Health Science Center in Houston. Panelists include: Rabbi Samuel E. Karff, Rabbi Emeritus of Congregation Beth Israel and Associate Director of the John P. McGovern Center for Humanities and Ethics and Visiting Professor in the Department of Family Medicine at the University of Texas Health Science Center at the Texas Medical Center. Cardinal DiNardo, the second Archbishop of the Archdiocese of Galveston-Houston and the first cardinal archbishop from a diocese in the Southern United States. Dr. Sheldon Rubenfeld, Clinical Professor of Medicine at Baylor College of Medicine. He is Board Certified in Internal Medicine and in Endocrinology, Diabetes, and Metabolism, and is a Fellow in both the American College of Physicians and the American College of Endocrinology. Dr. Rubenfeld has taught "Healing by Killing: Medicine During the Third Reich" for three years and "Jewish Medical Ethics" for seven years at Baylor College of Medicine. He created a six-month program about Medicine and the Holocaust at Holocaust Museum Houston, including an exhibit entitled How Healing Becomes Killing: Eugenics, Euthanasia, Extermination and a series of lectures by distinguished speakers entitled "The Michael E. DeBakey Medical Ethics Lecture Series".