TECHNOLOGY ASSESSMENT: SMALL-VOLUME INFUSION PUMPS

"Technology assessment is a comprehensive form of policy research that examines the short- and long-term social consequences of the application or use of technology" (US Congress 1967).^ This study explored a research methodology appropriate for technology assessment (TA) within the health industry. The case studied was utilization of external Small-Volume Infusion Pumps (SVIP) at a cancer treatment and research center. Primary and secondary data were collected in three project phases. In Phase I, hospital prescription records (N = 14,979) represented SVIP adoption and utilization for the years 1982-1984. The Candidate Adoption-Use (CA-U) diffusion paradigm developed for this study was germane. Compared to classic and unorthodox curves, CA-U more accurately simulated empiric experience. The hospital SVIP 1983-1984 trends denoted assurance in prescribing chemotherapy and concomitant balloon SVIP efficacy and efficiency. Abandonment of battery pumps was predicted while exponential demand for balloon SVIP was forecast for 1985-1987. In Phase II, patients using SVIP (N = 117) were prospectively surveyed from July to October 1984; the data represented a single episode of therapy. The questionnaire and indices, specifically designed to measure the impact of SVIP, evinced face validity. Compeer group data were from pre-SVIP case reviews rather than from an inpatient sample. Statistically significant results indicated that outpatients using SVIP interacted socially more than inpatients using the alternative technology. Additionally, the hospital's education program effectively taught clients to discriminate between self care and professional SVIP services. In these contexts, there was sufficient evidence that the alternative technology restricted patients activity whereas SVIP permitted patients to function more independently and in a social lifestyle, thus adding quality to life. In Phase III, diffusion forecast and patient survey findings were combined with direct observation of clinic services to profile some economic dimensions of SVIP. These three project phases provide a foundation for executing: (1) cost effectiveness analysis of external versus internal infusors, (2) institutional resource allocation, and (3) technology deployment to epidemiology-significant communities. The models and methods tested in this research of clinical technology assessment are innovative and do assess biotechnology. ^

An Extended Hierarchical Task Analysis for Error Prediction in Medical Devices

This paper introduces an extended hierarchical task analysis (HTA) methodology devised to evaluate and compare user interfaces on volumetric infusion pumps. The pumps were studied along the dimensions of overall usability and propensity for generating human error. With HTA as our framework, we analyzed six pumps on a variety of common tasks using Norman’s Action theory. The introduced method of evaluation divides the problem space between the external world of the device interface and the user’s internal cognitive world, allowing for predictions of potential user errors at the human-device level. In this paper, one detailed analysis is provided as an example, comparing two different pumps on two separate tasks. The results demonstrate the inherent variation, often the cause of usage errors, found with infusion pumps being used in hospitals today. The reported methodology is a useful tool for evaluating human performance and predicting potential user errors with infusion pumps and other simple medical devices.

Evaluating a medical error taxonomy

Healthcare has been slow in using human factors principles to reduce medical errors. The Center for Devices and Radiological Health (CDRH) recognizes that a lack of attention to human factors during product development may lead to errors that have the potential for patient injury, or even death. In response to the need for reducing medication errors, the National Coordinating Council for Medication Errors Reporting and Prevention (NCC MERP) released the NCC MERP taxonomy that provides a standard language for reporting medication errors. This project maps the NCC MERP taxonomy of medication error to MedWatch medical errors involving infusion pumps. Of particular interest are human factors associated with medical device errors. The NCC MERP taxonomy of medication errors is limited in mapping information from MEDWATCH because of the focus on the medical device and the format of reporting.

Diffusion tensor imaging of cocaine-treated rodents.

Studies in cocaine-dependent human subjects have shown differences in white matter on diffusion tensor imaging (DTI) compared with non-drug-using controls. It is not known whether the differences in fractional anisotropy (FA) seen on DTI in white matter regions of cocaine-dependent humans result from a pre-existing predilection for drug use or purely from cocaine abuse. To study the effect of cocaine on brain white matter, DTI was performed on 24 rats after continuous infusion of cocaine or saline for 4 weeks, followed by brain histology. Voxel-based morphometry analysis showed an 18% FA decrease in the splenium of the corpus callosum (CC) in cocaine-treated animals relative to saline controls. On histology, significant increase in neurofilament expression (125%) and decrease in myelin basic protein (40%) were observed in the same region in cocaine-treated animals. This study supports the hypothesis that chronic cocaine use alters white matter integrity in human CC. Unlike humans, where the FA in the genu differed between cocaine users and non-users, the splenium was affected in rats. These differences between rodent and human findings could be due to several factors that include differences in the brain structure and function between species and/or the dose, timing, and duration of cocaine administration.

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]

Evaluation of therapist and client language in Motivational Interviewing (MI) sessions: A secondary analysis of data from the Southern Methodist Alcohol Research Trial (SMART) study

In the United States, “binge” drinking among college students is an emerging public health concern due to the significant physical and psychological effects on young adults. The focus is on identifying interventions that can help decrease high-risk drinking behavior among this group of drinkers. One such intervention is Motivational interviewing (MI), a client-centered therapy that aims at resolving client ambivalence by developing discrepancy and engaging the client in change talk. Of late, there is a growing interest in determining the active ingredients that influence the alliance between the therapist and the client. This study is a secondary analysis of the data obtained from the Southern Methodist Alcohol Research Trial (SMART) project, a dismantling trial of MI and feedback among heavy drinking college students. The present project examines the relationship between therapist and client language in MI sessions on a sample of “binge” drinking college students. Of the 126 SMART tapes, 30 tapes (‘MI with feedback’ group = 15, ‘MI only’ group = 15) were randomly selected for this study. MISC 2.1, a mutually exclusive and exhaustive coding system, was used to code the audio/videotaped MI sessions. Therapist and client language were analyzed for communication characteristics. Overall, therapists adopted a MI consistent style and clients were found to engage in change talk. Counselor acceptance, empathy, spirit, and complex reflections were all significantly related to client change talk (p-values ranged from 0.001 to 0.047). Additionally, therapist ‘advice without permission’ and MI Inconsistent therapist behaviors were strongly correlated with client sustain talk (p-values ranged from 0.006 to 0.048). Simple linear regression models showed a significant correlation between MI consistent (MICO) therapist language (independent variable) and change talk (dependent variable) and MI inconsistent (MIIN) therapist language (independent variable) and sustain talk (dependent variable). The study has several limitations such as small sample size, self-selection bias, poor inter-rater reliability for the global scales and the lack of a temporal measure of therapist and client language. Future studies might consider a larger sample size to obtain more statistical power. In addition the correlation between therapist language, client language and drinking outcome needs to be explored.^

Expanding cities and expanding waistlines: Urban sprawl and its impact on obesity, how the adoption of smart growth statutes can build healthier and more active communities

For decades, American towns and cities have expanded from their established cores into the surrounding rural areas. U.S. population has grown but the land that we use has grown at an even faster pace, and our country has now become a largely suburban nation. Americans moved and continue to move out to the suburbs in search of better lives – for clean and healthy living, for larger homes, and for better resources. In many ways and for many Americans, the suburban lifestyle has been a great success. However, there are some unintended public health consequences of urban sprawl that must be recognized. As most Americans no longer walk or bicycle, increasingly sedentary lifestyles now contribute to greater levels of obesity, diabetes and other associated chronic diseases. This thesis reviewed the impacts of urban sprawl on the public's health specifically, as sprawl relates to decreased physical activity rates and increased obesity rates. The health effects and their connection with sprawl were identified, and available evidence was reviewed. Finally, this thesis described legal and policy solutions for addressing the health effect through improving the design of our built environment and by recommending that governments adopt and implement Smart Growth statutes that incorporate a public health component and require public health involvement. ^

Perceived risk and outcome expectancy on the practice of home infusion technique in a hemophilia population

This study described home infusion techniques and practices, measured the perceived risk of HIV and hepatitis transmission to self and others, and measured the outcome expectancy of following risk reduction guidelines for 90 hemophilia patients and/or their infusion assistants. It also assessed general knowledge of HIV and hepatitis information for the same population.^ The study subjects were hemophilia patients or their infusion assistants from the Gulf States Hemophilia Center in Houston, the El Paso Satellite Hemophilia Clinic in El Paso, or Texas members of the Women Outreach Network of the National Hemophilia Foundation (WONN) group. Each subject was interviewed either by telephone or in person. The questionnaire used was developed for the study and consisted of 60 items. These items assessed general demographics for the patients and assistants, including questions about their training to do infusions as well as the actual practices, measured perceived personal risk for the transmission of HIV or hepatitis to the assistants, perceived risk of transmission of HIV or hepatitis to others for assistants and self-infusers, and the outcome expectancy for following recommended risk reduction guidelines also for both groups.^ The theoretical framework used assumed that perceived risk and outcome expectancy would be predictive of behavior. The findings did not support this theory. Instead, the findings suggest that infusion behavior is habitual in nature; most respondents perform exactly the same behavior for every infusion. Since none of the variables selected were predictive of the compliance behavior for home infusion the teaching method should be directed towards mastery learning, or learning that will incorporate the correct behavior into a habitual pattern of home infusion. ^

Application of the general linear model to assess the effect of missing data on bone marrow mononuclear cell therapy with infusion timing and follow-up MRI

With most clinical trials, missing data presents a statistical problem in evaluating a treatment's efficacy. There are many methods commonly used to assess missing data; however, these methods leave room for bias to enter the study. This thesis was a secondary analysis on data taken from TIME, a phase 2 randomized clinical trial conducted to evaluate the safety and effect of the administration timing of bone marrow mononuclear cells (BMMNC) for subjects with acute myocardial infarction (AMI).^ We evaluated the effect of missing data by comparing the variance inflation factor (VIF) of the effect of therapy between all subjects and only subjects with complete data. Through the general linear model, an unbiased solution was made for the VIF of the treatment's efficacy using the weighted least squares method to incorporate missing data. Two groups were identified from the TIME data: 1) all subjects and 2) subjects with complete data (baseline and follow-up measurements). After the general solution was found for the VIF, it was migrated Excel 2010 to evaluate data from TIME. The resulting numerical value from the two groups was compared to assess the effect of missing data.^ The VIF values from the TIME study were considerably less in the group with missing data. By design, we varied the correlation factor in order to evaluate the VIFs of both groups. As the correlation factor increased, the VIF values increased at a faster rate in the group with only complete data. Furthermore, while varying the correlation factor, the number of subjects with missing data was also varied to see how missing data affects the VIF. When subjects with only baseline data was increased, we saw a significant rate increase in VIF values in the group with only complete data while the group with missing data saw a steady and consistent increase in the VIF. The same was seen when we varied the group with follow-up only data. This essentially showed that the VIFs steadily increased when missing data is not ignored. When missing data is ignored as with our comparison group, the VIF values sharply increase as correlation increases.^