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Polycyclic aromatic hydrocarbon exposures of children in low-income families.

Children in low-income families may have high exposures to polycyclic aromatic hydrocarbons (PAH). Such exposures could result from household proximity to heavy traffic or industrial sources, environmental tobacco smoke, contaminated house dust or soil, among others. The objectives of this study were: to establish methods for measuring total PAH exposure of children in low-income families, to estimate the PAH exposures of these children, and to estimate the relative importance of the environmental pathways for PAH exposure. Analytical methods to determine PAH in air, dust, soil, and food and to determine hydroxy-PAH in urine samples were evaluated and validated. A two-home pilot study was conducted in downtown Durham, North Carolina (NC) during February 1994. One smoker's and one nonsmoker's household, which had preschool children and income at or below the official U.S. poverty level, participated. A nine-home winter and a nine-home summer study were conducted in Durham and the NC Piedmont area during February 1995 and August 1995, respectively. A summer study in four smokers' homes was also conducted. In each of these studies, multimedia samples were collected and analyzed for PAH or hydroxy-PAH. Summary statistics, Pearson correlations, and analysis of variance were performed on the combined data from these four field studies. An effective screening method was established for recruiting low-income families. The field protocol involved measurements of three homes in 2-day periods. This protocol should be suitable for large-scale studies. The results showed that indoor PAH levels were generally higher than outdoor PAH levels. Higher indoor PAH levels were observed in the smokers' homes compared to nonsmokers' homes. Higher outdoor PAH levels were found in inner city as opposed to rural areas. The relative concentration trend for PAH in dust and soil was: house dust > entryway dust > pathway soil. The PAH concentrations in adults' food samples were generally higher than those in children's food samples. Children's potential daily doses of PAH were higher than those of adults in the same household, when intakes were normalized to body weights. Inhalation is an important pathway for children's exposure to total PAH because of the high levels of naphthalene present in both indoor and outdoor air. Dietary ingestion and nondietary ingestion pathways became more important for children's exposure to the B2 PAH (ranked as probable human carcinogens, B2 by the U.S. EPA's Integrated Risk System), most of which are of low volatility. The analysis of variance results showed that inner city participants had higher total exposure to B2 PAH than did rural participants.

Adult↗

Evaluations of primary metals from NHEXAS Arizona: distributions and preliminary exposures. National Human Exposure Assessment Survey.

NHEXAS AZ is a multimedia, multipathway exposure assessment survey designed to evaluate metals and other analytes. This paper reports the analyte-specific concentration distributions in each of the media examined (air, soil, house dust, food, beverage, and water), for various methodologies used (inductively coupled plasma-atomic emission spectroscopy and hydride generation-atomic absorption spectroscopy). Results are reported for the five primary metals (Pb, As, Cd, Cr, and Ni). Ingestion was the most important pathway of exposure. Metal concentrations in air were very low (ng/m3) and found only above the 90th percentile. Metals were commonly found in house dust and soil. Exposure transfer coefficients minimize the importance of this component for those over the age of 6 years. When ranked by exposure, food, beverage, and water appeared to be the primary contributors of metal exposure in NHEXAS AZ. For instance, at the 90th percentile, Pb was undetected in air, found at 131 and 118 microg/m3 in floor dust and soil, respectively, and measured at 16 microg/kg in food, 7.1 microg/kg in beverage, and 2.0 and 1.3 microg/l in drinking and tap water, respectively. We calculated preliminary estimates of total exposure (microg/day) for each participant and examined them independently by age, gender, and ethnicity as reported by the subjects in the NHEXAS questionnaire. At the 90th percentile for Pb, total exposures were 64 microg/day across all subjects (n=176); adult men (n=55) had the greatest exposure (73 microg/day) and children (n=35) the least (37 microg/day). Hispanics (n=54) had greater exposure to Pb (68 microg/day) than non-Hispanics (n=119; 50 microg/day), whereas non-Hispanics had greater exposure for all other metals reported. These results have implications related to environmental justice. The NHEXAS project provides information to make informed decisions for protecting and promoting appropriate public health policy.

Adolescent↗

The National Human Exposure Assessment Survey (NHEXAS) study in Arizona--introduction and preliminary results.

The objective of the National Human Exposure Assessment Survey (NHEXAS) in Arizona is to determine the multimedia distribution of total human exposure to environmental pollutants in the classes of metals, pesticides, and volatile organic compounds (VOCs) for the population of Arizona. This was accomplished by studying a probability-based sample of the total population in Arizona with a nested design for the different stages of sampling (954 Stage I, 505 Stage II, and 179 Stage III participants). This report compares the study population demographics with those from the U.S. Census and provides preliminary data on the distributions of the example pollutant for each class, lead for metals, chlorpyrifos for pesticides, and benzene for metals. The probability-based sample age and gender demographics compare reasonably well with the Census data (1990 Census and 1996 Census Estimate). The race/ethnicity compared less well with 21% Hispanics in the 1996 Census Estimate and 42% Hispanics in the entire NHEXAS-Arizona sample and 30% Hispanics as Stage III participants for this study. The chemical analyses of the various media (yard soil, foundation soil, house dust, indoor air, outdoor air, drinking water, food, and beverage) show generally low levels of the representative pollutants. The 50th percentiles of the distributions are generally near or below the analytical detection limits, and applicable Federal action limits were rarely exceeded.

Adolescent↗

An assessment of the data quality for NHEXAS--Part I: Exposure to metals and volatile organic chemicals in Region 5.

A National Human Exposure Assessment Survey (NHEXAS) was performed in U.S. Environmental Protection Agency (U.S. EPA) Region V, providing population-based exposure distribution data for metals and volatile organic chemicals (VOCs) in personal, indoor, and outdoor air, drinking water, beverages, food, dust, soil, blood, and urine. One of the principal objectives of NHEXAS was the testing of protocols for acquiring multimedia exposure measurements and developing databases for use in exposure models and assessments. Analysis of the data quality is one element in assessing the performance of the collection and analysis protocols used in NHEXAS. In addition, investigators must have data quality information available to guide their analyses of the study data. At the beginning of the program quality assurance (QA) goals were established for precision, accuracy, and method quantification limits. The assessment of data quality was complicated. First, quality control (QC) data were not available for all analytes and media sampled, because some of the QC data, e.g., precision of duplicate sample analysis, could be derived only if the analyte was present in the media sampled in at least four pairs of sample duplicates. Furthermore, several laboratories were responsible for the analysis of the collected samples. Each laboratory provided QC data according to their protocols and standard operating procedures (SOPs). Detection limits were established for each analyte in each sample type. The calculation of the method detection limits (MDLs) was different for each analytical method. The analytical methods for metals had adequate sensitivity for arsenic, lead, and cadmium in most media but not for chromium. The QA goals for arsenic and lead were met for all media except arsenic in dust and lead in air. The analytical methods for VOCs in air, water, and blood were sufficiently sensitive and met the QA goals, with very few exceptions. Accuracy was assessed as recovery from field controls. The results were excellent (> or = 98%) for metals in drinking water and acceptable (> or = 75%) for all VOCs except o-xylene in air. The recovery of VOCs from drinking water was lower, with all analytes except toluene (98%) in the 60-85% recovery range. The recovery of VOCs from drinking water also decreased when comparing holding times of < 8 and > 8 days. Assessment of the precision of sample collection and analysis was based on the percent relative standard deviation (% RSD) between the results for duplicate samples. In general, the number of duplicate samples (i.e., sample pairs) with measurable data were too few to assess the precision for cadmium and chromium in the various media. For arsenic and lead, the precision was excellent for indoor, and outdoor air (< 10% RSD) and, although not meeting QA goals, it was acceptable for arsenic in urine and lead in blood, but showed much higher variability in dust. There were no data available for metals in water and food to assess the precision of collection and analysis.

Adolescent↗

Modeled estimates of chlorpyrifos exposure and dose for the Minnesota and Arizona NHEXAS populations.

This paper presents a probabilistic, multimedia, multipathway exposure model and assessment for chlorpyrifos developed as part of the National Human Exposure Assessment Survey (NHEXAS). The model was constructed using available information prior to completion of the NHEXAS study. It simulates the distribution of daily aggregate and pathway-specific chlorpyrifos absorbed dose in the general population of the State of Arizona (AZ) and in children aged 3-12 years residing in Minneapolis-St. Paul, Minnesota (MSP). Pathways included were inhalation of indoor and outdoor air, dietary ingestion, non-dietary ingestion of dust and soil, and dermal contact with dust and soil. Probability distributions for model input parameters were derived from the available literature, and input values were chosen to represent chlorpyrifos concentrations and demographics in AZ and MSP to the extent possible. When the NHEXAS AZ and MSP data become available, they can be compared to the distributions derived in this and other prototype modeling assessments to test the adequacy of this pre-NHEXAS model assessment. Although pathway-specific absorbed dose estimates differed between AZ and MSP due to differences in model inputs between simulated adults and children, the aggregate model results and general findings for simulated AZ and MSP populations were similar. The major route of chlorpyrifos intake was food ingestion, followed by indoor air inhalation. Two-stage Monte Carlo simulation was used to derive estimates of both inter-individual variability and uncertainty in the estimated distributions. The variability in the model results reflects the difference in activity patterns, exposure factors, and concentrations contacted by individuals during their daily activities. Based on the coefficient of variation, indoor air inhalation and dust ingestion were most variable relative to the mean, primarily because of variability in concentrations due to use or no-use of pesticides. Uncertainty analyses indicated a factor of 10-30 for uncertainty of model predictions of 10th, 50th, and 90th percentiles. The greatest source of uncertainty in the model stems from the definition of no household pesticide use as no use in the past year. Because chlorpyrifos persists in the residential environment for longer than a year, the modeled estimates are likely to be low. More information on pesticide usage and environmental concentrations measured at different post-application times is needed to refine and evaluate this and other pesticide exposure models.

Age Distribution↗

Temporal patterns of activities potentially related to pesticide exposure.

Longitudinal information on human activity patterns is required to perform reliable assessments of chronic exposure to pesticides in nonoccupational settings. As part of a longitudinal, multimedia exposure survey in Maryland, USA, we collected 2521 person-days of information on the frequency of five activities that are potentially important to pesticide exposure in residential settings: preparation of pesticides; application of pesticides; contact with soil on the skin; contact with grass on the skin; and contact with carpet. Logistic regression was used to evaluate the data for variability by time of year, day of week, and several demographic factors. Eight percent of the population reported preparing pesticides on at least one occasion over the year, while 24% of the population applied pesticides at least once. The majority of the population reported contact with soil (68%), grass (72%), and carpet (64%) over the course of a year. Skin contact with soil and grass was found to occur approximately twice as frequently (p<0.001) in spring and summer periods than in fall and winter periods. Similarly, contact with soil and grass was about 50% (p<0.05) more likely to occur on weekend days than on weekdays. These results indicate that short-term measurements (e.g., 1-day or 1-week) of these activities for an individual may not be equivalent to long-term average patterns. We also found that selected demographic characteristics were significant predictors of several of these activities. Thus, some demographic characteristics may be useful in categorizing exposure although it is unlikely that a single short-term measurement will suffice to describe annual average activity or multiple short-term activity periods.

Activities of Daily Living↗

Assessment of human exposure to copper: a case study using the NHEXAS database.

Copper is an essential trace element and adverse health effects can potentially be associated with both very low and very high intakes. Accurate estimates of inhalation and ingestion (food and drinking water) exposures are therefore needed in order to realistically assess any effects of the distribution of copper intakes within the general population. The work presented here demonstrates an application of a customized subset of the MENTOR/SHEDS-4M computational system (Modeling ENvironment for TOtal Risk studies, employing the Stochastic Human Exposure and Dose Simulation approach, for Multimedia, Multipathway, Multiroute exposures to Multiple co-occurring contaminants. The application utilized data from the National Human Exposure Assessment Survey (NHEXAS) for USEPA Region V as well as from a variety of other available databases. The case study, using a statistical population-based modeling framework, was performed for Eaton County, MI. The results of the simulations, aggregated for six age subgroups of the general population, suggest that food intake is the major pathway for total copper exposure, while drinking water can have significant contributions at the tail of the distribution of intakes. Specifically, it was estimated that over 80% of the county population received potential doses of copper from food that were lower than the Institute of Medicine (IOM) Recommended Dietary Allowance (RDA) value of 900 microg/day. Furthermore, the total combined potential dose from food and water was only about two times greater than the recommended value only for individuals with intakes in the range above the 99th percentile of both food and water intakes. The values were well below the upper tolerable intake value of 10,000 microg/day. The inhalation route consistently acted as only a minor contributor to the total exposure.

Adolescent↗

Levels of compliance shown by hypertensive patients and their attitude toward their illness.

AIM: The aim of this paper is to describe hypertensive patients' compliance by finding out more specifically what compliance, intention, activity, responsibility and collaboration mean in the treatment of hypertensive patients. A further aim was to clarify their attitudes toward their illness. RATIONALE: This study is part of a project titled 'Patients' self-motivated control of hypertension. METHOD: The intervention consists of a multimedia computer program and effective lifestyle counselling. Nine male and 12 female patients from one municipality were included in an intervention programme. Data were collected through thematic interviews and analysed using content analysis. FINDINGS: Four levels of compliance were found: subconscious, cognitive, action and attitudinal level. Patients also had four different ways of feeling about hypertension and its treatment: some were careless, some were serious, some adjusted well and yet others felt frustrated. CONCLUSION: Health care professionals should recognize each patient's way of complying with his/her treatment and his/her attitude toward the illness. Different patients need different kinds of care and support. In addition health care professionals should also recognize their own attitudes toward hypertension and the patient's position in the health care system.

Adolescent↗

Development and integration of CAL: a case study in medicine.

CONTEXT: The Faculty of Medicine and Medical Sciences at the University of Aberdeen viewed the use of Computer Assisted Leaning (CAL) and other IT based learning resources as a possible way of coping with an increase in student numbers whilst maintaining or increasing the quality of medical teaching. OBJECTIVES: Our primary objective was to develop and integrate Computer Assisted Learning (CAL) applications into the undergraduate medical curriculum. SUBJECTS/MATERIALS: A wide spectrum of CAL applications were developed dealing with many topics in the curriculum. METHODS: We formulated a structured approach to CAL development by establishing a team of professionals (forming a CAL Unit), using existing expertise and by implementing a process to ensure that the CAL had a maximum impact upon the curriculum. The CAL included multimedia tutorials, learning guides, computer aided assessment (CAA) and Model Patients. RESULTS: There are now over 150 IT based learning resources in our curriculum and course evaluation has showed that these have been well received by students. CONCLUSIONS: We conclude that with the wise use of the many skills and facilities usually available within an institution and by promoting collaborative projects with others, the production of high quality CAL is possible within most institutions.

Computer-Assisted Instruction↗

Time to learn: the outlook for renewal of patient-centred education in the digital age.

BACKGROUND: Major forces in society and within health systems are fragmenting patient care and clinical learning. The distancing of physician and trainee from the patient undermines learning about the patient-doctor relationship. The disconnection of care and learning from one successive venue to another impedes the ability of trainees to learn about illness longitudinally. METHODS: As a conceptual piece, our methods have been those of witnessing the experiences of patients, practitioners, and students over time and observing the impact of fragmented systems and changing expectations on care and learning. We have reflected on the opportunities created by digital information systems and interactive telemedicine to help renew essential relationships. RESULTS: Although there is, as yet, little in the literature on educational or health outcomes of this kind of technological enablement, we anticipate opportunities for a renewed focus on the patient in that patient's own space and time. Multimedia applications can achieve not only real-time connections, but can help construct a "virtual patient" as a platform for supervision and assessment, permitting preceptors to evaluate trainee-patient interactions, utilization of Web-based data and human resources, and on-line professionalism. CONCLUSIONS: Just as diverse elements in society are capitalizing upon digital technology to create advantageous relationships, all of the elements in the complex systems of health care and medical training can be better connected, so as to put the patient back in the centre of care and the trainee's ongoing relationship to the patient back in the centre of education.

Clinical Competence↗

The impact of a new educational strategy on acquiring neonatology skills.

OVERVIEW: A shortage of staff for teaching neonatology skills to large numbers of students, in small groups and following a new curriculum, necessitated an innovative educational strategy. This entailed the development and implementation of an interactive multimedia program (CD-ROM) to deliver information about skills and to demonstrate them. METHODS: Students had to study a specific skill using the CD-ROM and then practise in the Skills Laboratory, supported by lecturers who provided formative evaluation. OBJECTIVES: The aims of this study were to assess the students' perspectives on the new strategy, and to compare the skills of students following the new curriculum to those of students following the traditional curriculum, who do not follow structured programmes on practical skills but experience a practical neonatology rotation. RESULTS: The evaluation of the CD-ROM program was very favourable. The majority of students still preferred live demonstrations but found the CD-ROM useful for revision purposes. With the exception of one skill, endotracheal intubation, the new curriculum students were found to be as competent as the students following the traditional curriculum and performed mask ventilation and cardiac massage significantly better than them.

CD-ROM↗

Adoption and integration of simulation-based learning technologies into the curriculum of a UK Undergraduate Education Programme.

CONTEXT: At a time of significant changes in medical education world-wide, the international dimensions and global issues relating to the application of new learning technologies have been recognised. OBJECTIVE: The aim of this paper is to describe the adoption and integration within the curriculum in one United Kingdom (UK) medical school of 'Harvey', the Cardiology Patient Simulator, and the UMedic multimedia computer-based cardiology curriculum - resources developed in a medical school in the USA. PARTICIPANTS: The integration of the resources into the curriculum is described by 3 teachers actively involved in the cardiology curriculum of the UK medical school and 3 teachers associated with the development of resources in the USA. ASPECTS CONSIDERED: The review considers the adoption of Harvey and UMedic in the UK in programmes in relation to: curricular issues, training needs, learning outcomes, curriculum content and sequences of content, educational strategies, teaching and learning methods, assessment, communication about the curriculum and management of the curriculum. CONCLUSIONS: Learning resources, in the form of simulators and computer-based learning modules, developed in one country can be successfully adopted and implemented in another. Facets that facilitated the adoption included close liaison between the developers of the resources in the USA and the implementers in the UK, and careful and systematic planning including in-depth integration of the simulation-based resources into the required curriculum rather than their relegation to a peripheral ad hoc position. The successful use of simulators such as Harvey requires the presence of a 'champion', a clinician educator and a supporting administrative staff who ensure the simulator's appropriate use.

Cardiology↗

The impact of educational videotapes on water contact behaviour of primary school students in the Dongting Lakes region, China.

Multimedia has become increasingly important in educational programmes in schools in all societies, and has potential value for health education. We developed a video and a comic book on the transmission and prevention of schistosomiasis for use in primary schools in endemic areas of China. The material was designed to increase children's knowledge of schistosomiasis as an environmental disease and to encourage them to reduce their contact with unsafe water sources. To test the effectiveness of the video and booklet, a quasi-experimental study was conducted among 1,739 children in 50 primary schools in the Dongting Lake region. A self-administered questionnaire pre- and post-intervention showed a significant increase in knowledge about schistosomiasis in the intervention schools. Significantly, this change was associated with a decrease in contact with unsafe water sources, as established from water contact observations. This behavioural change suggests the value of short, targeted educational interventions to decrease risk of infection.

Adolescent↗

Implementing shared decision-making in routine practice: barriers and opportunities.

OBJECTIVE: Determine feasibility of shared decision-making programmes in fee-for-service hospital systems including physicians' offices and in-patient facilities. DESIGN: Survey and participant observation. Data obtained during Phase 1 of a patient outcome study. SETTINGS AND PARTICIPANTS: Three hospitals in Michigan: one 299-bed rural regional hospital, one 650-bed urban community hospital, one 459-bed urban and suburban teaching hospital. All nurses and physicians who agreed to use the programmes participated in the evaluation (n = 34). INTERVENTION: Two shared decision-making(R) (SDP) multimedia programmes: surgical treatment choice for breast cancer and ischaemic heart disease treatment choice. MAIN OUTCOME MEASURES: (1) clinicians' evaluations of programme quality; (2) challenges in hospital settings; and (3) patient referral rates. RESULTS: SDP programmes were judged to be clear, accurate and about the right length and amount of information. Programmes were judged to be informative and appropriate for patients to see before making a decision. Clinicians were neutral about patients' desire to participate in treatment decision-making. Referral volume to SDPs was lower than expected: 24 patients in 7 months across three hospitals. Implementation challenges centred on time pressures in patient care. CONCLUSIONS: Productivity and time pressure in US health care severely constrain shared decision-making programme implementation. Physician referral may not be a reliable mechanism for patient access. Possible innovations include: (1) incorporation into the informed consent process; (2) provider or payer negotiated requirement in the routine hospital procedure to use the SDP as a quality indicator; and (3) payer reimbursement to professional providers who make SDP programmes available to patients.

Journal Article↗

The URO Mentor: development and evaluation of a new computer-based interactive training system for virtual life-like simulation of diagnostic and therapeutic endourological procedures.

OBJECTIVE: To overcome the current disadvantages of traditional training methods for ureterorenoscopy and percutaneous nephrolitholapaxy, using the URO Mentor (Simbionix, Tel Aviv, Israel) computer-assisted simulator. METHODS: The URO Mentor device for training and quality control in ureterorenoscopy was developed using virtual reality, multimedia technology and intelligent tutoring systems. The central software system features a proprietary visualization engine (the SVE) which allows real-time simulation by offering a high-level object-orientated application program interface (written in C++) available for use with either Microsoft, DirectX 7 or OpenGL as platforms. The SVE includes general procedures to allow two- (2D) and three-dimensional (3D) rendering, collision detection, collision correction, 3D morphing, 2D image manipulation, texture mapping, 'bump' mapping, video texture, X-ray rendering, special effects (blood, smoke, stone fragments and more) and reflections. RESULTS: The system allows a complete training session on a wide range of procedures by offering different types of cases and virtual patients, and features a full representation of the endourological procedures under direct vision and by using interactive fluoroscopy with a contrast agent. The supported tools include: baskets, graspers, intracorporal lithotripters, guidewires, catheters, stents, biopsy and dilatation devices. The endourological procedures that can be performed are lithotripsy, tumour resection, treatment of strictures and obstructions, stent placement and biopsies. CONCLUSION: The URO Mentor introduces a new generation of mannequin equipped with a special haptic device, providing trainees with an unparalleled life-like sensation while training for diagnostic and therapeutic endourological procedures. By bringing key advances into urological simulation (e.g. with the real-time X-ray renderer) and by integrating in a single system both high-quality simulation and learning tools, the URO Mentor provides new perspectives for computer-based urological training systems and methods.

Computer Simulation↗

Techno pearls for digital image management.

BACKGROUND: The past decade has provided a paradigm shift in image management. Technological advances have enabled affordable, high-quality digital clinical photography. In addition, this technology has enabled doctors to easily compose and present multimedia lectures with programs such as Microsoft PowerPoint. Since most practitioners already possess large numbers of conventional slides and photographs, digitization is required to convert these to a usable format. Depending on the type of image and resolution, it can take anywhere from 30 seconds to several minutes to scan each slide. This drawback delays or prevents many practitioners from switching to digital technology. OBJECTIVE: Using a digital camera and the XP version of Windows, some common tasks associated with digital images and PowerPoint presentations may be simplified and facilitated. METHODS: Using common digital cameras and computer image editing software, slides, photographs, radiographs, and textbook images may be digitized in seconds with adequate quality for most common clinical and educational applications. In addition, the use of new dual monitor functionality is discussed. This new technology comes standard with Windows XP and allows the use of two monitors simultaneously, allowing the user to view thumbnail images on one monitor and the PowerPoint presentation on the other monitor. Images may be dragged and dropped into the presentation, thereby avoiding repetitive menu commands. RESULTS: The author shows several techniques and shortcuts to assist the clinical practitioner in digitizing slides and facilitating the management of these images in PowerPoint presentations. CONCLUSION: A digital camera can be used to adequately digitize most slide pictures, and these images can be managed in a more simple and direct manner utilizing the Windows XP operating system that is shipping with most new computers.

Dermatology↗

Strategic development of a master's program on the World Wide Web.

Quality teaching requires more than masterful professors. In today's academic environments, leaders in educational institutions have responsibilities to supply fiscal and human resources that support settings conducive to learning and that instill human, educational, and professional values. Recent technologic advances have shifted the capacities to deliver programs of study outside traditional classrooms. The World Wide Web can deliver nursing courses that are complex, multimedia, and interactive. Planning to offer a degree program on-line requires examining the organization's mission and philosophy as well as allocating human and fiscal resources to the project. As leaders implement innovations, such as distance learning on-line, they must address the organization's political challenges and cultural changes. When leaders seek to introduce innovation within their organizations, they must be prepared for excitement as well as anxiety and resistance. Leadership also requires evaluating performance and outcomes for quality education. In addition, they strive to meet expectations of quality of all stakeholders. J Prof Nurs 17:166-172, 2001.

Education, Nursing, Graduate↗

Development of an internet-based protocol to facilitate randomized clinical trials in pediatric surgery.

BACKGROUND/PURPOSE: Randomized clinical trials (RCTs) perhaps are the best method available for the comparison of therapeutic interventions, yet these studies remain scarce in the pediatric surgery literature. The infrequency of surgical conditions, parents' refusal to participate, and difficulty with standardizing operative technique are potential obstacles to conducting multicenter randomized trials. Novel applications of information technology can potentially overcome these obstacles and facilitate randomized trials in pediatric surgery. METHODS: Through collaboration with our Biostatistics Department, an Internet-based protocol was developed to facilitate our own multicenter trial for the surgical treatment of necrotizing enterocolitis. A secure, on-line data entry system was developed to manage all aspects of patient care data. Data are validated during the entry phase and directly uploaded into a clinical database for safety monitoring and analysis. Multimedia resources available online were developed to encourage standardization of surgical and nonoperative therapy. Comprehensive informed consent, educational and other support resources are available on line for the parents and family members of patients. These include an 8-minute video detailing pathophysiology, treatment options, and important informed consent issues surrounding the trial. The website also provides administrative support to study centers and periodic updates on trial progress to the medical community at large. CONCLUSIONS: Internet-based protocols may facilitate trials in pediatric surgery by reducing administrative costs, improving standardization of surgical technique, and potentially increasing enrollment success rates. Future investigation will examine the impact of this protocol on the education, knowledge base, and attitudes of parents, as well as determine the efficiency and overall cost effectiveness of this data management strategy.

Clinical Protocols↗