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Creating an infrastructure for training in the responsible conduct of research: the University of Pittsburgh's experience.

In response to public concerns about the consequences of research misconduct, academic institutions have become increasingly cognizant of the need to implement comprehensive, effective training in the responsible conduct of research (RCR) for faculty, staff, students, and external collaborators. The ability to meet this imperative is challenging as universities confront declining financial resources and increasing complexity of the research enterprise. The authors describe the University of Pittsburgh's design, implementation, and evaluation of a Web-based, institution-wide RCR training program called Research and Practice Fundamentals (RPF). This project, established in 2000, was embedded in the philosophy, organizational structure, and technology developed through the Integrated Advanced Information Management Systems grant from the National Library of Medicine. Utilizing a centralized, comprehensive approach, the RPF system provides an efficient mechanism for deploying content to a large, diverse cohort of learners and supports the needs of research administrators by providing access to information about who has successfully completed the training. During its first 3 years of operation, the RPF served over 17,000 users and issued more than 38,000 training certificates. The 18 modules that are currently available address issues required by regulatory mandates and other content areas important to the research community. RPF users report high levels of satisfaction with content and ease of using the system. Future efforts must explore methods to integrate non-RCR education and training into a centralized, cohesive structure. The University of Pittsburgh's experience with the RPF demonstrates the importance of developing an infrastructure for training that is comprehensive, scalable, reliable, centralized, affordable, and sustainable.

Academic Medical Centers↗

The year 2000 initiative: implications for comprehensive school health.

Implementing comprehensive school health programs presents one of our nation's key challenges for the 1990s and beyond. Whether we are talking about Goals 2000 or Healthy People 2000, we will meet the challenge only through the combined efforts of the education and health sectors working as partners at the national, state, and community levels and, perhaps most importantly, at the level of the individual elementary and secondary schools.

Adolescent↗

Interactive microcomputer for acquisition of patient information.

Written records and first-generation hospital information systems do not meet their primary purpose to assist physicians in solving patients' problems. Simply automating the present chart formats is not the answer. An example of the concept needed for charting is the intensive care unit chart. Anesthesiology charts provide little useful information for the continued care of the patient postoperatively. They serve principally as legal archival documents. Automation of the anesthesia record should free the anesthesiologist of the need to search for preoperative information and to manually record most information intraoperatively. Decisions about how much data to archive and how to extract the data pertinent to continuing care are the challenges for physicians. The technologic tools are available for the design and implementation of a software system that focuses on effective communication of the patient's problems throughout the perioperative period as the patient moves from ward to operating room, through the recovery room and intensive care unit, and to the ward and home.

Anesthesiology↗

Measuring quality of life in patients with breast cancer: a systematic review of reliable and valid instruments available in Japan.

BACKGROUND: Little is known about the availability and psychometric properties of instruments to measure quality of life (QOL) in clinical research on Japanese patients with breast cancer. The purpose of this systematic review is to find reliable and valid instruments available in Japan, and to summarize their characteristics. METHODS: Instruments available in Japan were found through a systematic search of the literature. Each instrument identified was evaluated for item development, reliability, validity, interpretability and utility. RESULTS: Six questionnaires to measure health-related QOL (the QOL-ACD, the EORTC QLQ-C30, the EORTC QLQ-BR23, the FACT-B, the SF-36, the WHO/QOL-26) and five scales to quantify the psychological burden (the STAI, the POMS, the SDS, the HADS, the GHQ), for which reliability and validity have been documented, are available in Japanese. All instruments were developed in foreign countries except for the QOL-ACD. Two of the QOL questionnaires were specific to breast cancer (the EORTC QLQ-BR23, the FACT-B). Though the measurements can be interpreted in some manner, the meaning of change scores over time has been documented for only three instruments (the EORTC QLQ-C30, the FACT-B, and the GHQ). CONCLUSIONS: The review provides grounds for designing and implementing quantitative research on QOL of breast cancer patients in Japan. Methodological challenges, however, continue, particularly for validating instruments with regard to various study populations of Japanese people and demonstrating the clinical importance of change scores.

Breast Neoplasms↗

Overview of publicly funded managed behavioral health care.

Using MEDLINE and other Internet sources, the authors perform a systematic review of published literature. A total of 109 articles and reports are identified and reviewed that address the development, implementation, outcomes, and trends related to Managed behavioral health care (MBHC). MBHC remains a work in progress. States have implemented their MBHC programs in a number of ways, making interstate comparisons challenging. While managed behavioral health care can lower costs and increase access, ongoing concerns about MBHC include potential incentives to under-treat those with more severe conditions due to the nature of risk-based contracting, the tendency to focus on acute care, difficulties assuring quality and outcomes consistently across regions, and a potential cost-shift to other public agencies or systems. Success factors for MBHC programs appear to include stakeholder involvement in program and policy development, effective contract development and management, and rate adequacy.

Cost Savings↗

An approach to the validation of novel molecular markers of breast cancer via TMA-based FISH scanning.

Tissue microarrays (TMA) are valuable tools for validating results of array-based comparative genomic hybridization (ACGH) and other translational research applications requiring independent verification of genomic gains and losses by fluorescence in situ hybridization (FISH). However, spatial orientation and accurate manual tracking of the TMA cores is challenging and prone to error. Image analysis combined with core tracking software, implemented via an automated FISH scanning workstation, represents a new approach to FISH and TMA-based validation of novel genomic changes discovered by ACGH in breast and other cancers. Automated large-scale tissue microarray validation FISH studies of genomic gains and losses identified by ACGH for breast cancer are feasible using an automated imaging scanner and tracking/classifying software. Furthermore, by leveraging the bifunctional fluorescent and chromogenic properties of the alkaline phosphatase chromogen fast red K and combining the technology with FISH, correlative and simultaneous phenotype/genotype studies may be enabled.

Biomarkers, Tumor↗

Trends in chemotherapy administration.

Oncology nurses must respond to the challenges provided by the outpatient administration of chemotherapy. They must design and implement cancer care systems for the future that focus on the patient and family and are efficient, effective, and delivered at reasonable cost.

Adult↗

From too little too late to early and often: child psychiatry education during medical school (and before and after).

In this article we propose developmentally informed remedies to the challenges that face research training. The initiatives described in it have been implemented to various degrees at our institution, and several are already being replicated or expanded through strategic partnerships across the country. We are fortunate to work in an environment in which child and adolescent psychiatry is visible and well represented, but we are aware than many of the settings in which education and recruitment needs are most pressing may not have the range of our resources. We view our different programs as seamlessly interconnected with one another but present them as separate entities to facilitate the incorporation of different components into local realities.

Adolescent↗

Practice-based research networks: nursing centers and communities working collaboratively to reduce health disparities.

Practice-based research networks (PBRNs) can provide a range of opportunities for nurses working in primary care settings. This article reports on the early experiences of the Midwest Nursing Centers Consortium Research Network (MNCCRN), one of only two nursing PBRNs in the nation. Findings from the MNCCRN's first research study, Wellness for a Lifetime, indicate success with implementing research across geographically distant sites, and positive client outcomes related to improving nutrition and physical activity. Lessons learned in establishing a PBRN and implementing research studies in the real world are described as well as challenges for the future.

Community Health Centers↗

CenteringPregnancy and the current state of prenatal care.

Prenatal care is often credited with improving pregnancy outcomes. Yet rates of low birthweight (LBW) and prematurity have risen in recent decades, calling into question the efficacy of traditional prenatal routines. Proposals have included broadening the objectives of prenatal care beyond prevention of LBW and enriching care to provide education and support for pregnant women. CenteringPregnancy, an innovative model of prenatal care that integrates extensive health education and group support with the standard prenatal exam, incorporates many of these elements. Impediments to wider implementation of CenteringPregnancy are explored, as well as proposals for addressing these challenges.

Female↗

Drug discovery from medicinal plants.

Current research in drug discovery from medicinal plants involves a multifaceted approach combining botanical, phytochemical, biological, and molecular techniques. Medicinal plant drug discovery continues to provide new and important leads against various pharmacological targets including cancer, HIV/AIDS, Alzheimer's, malaria, and pain. Several natural product drugs of plant origin have either recently been introduced to the United States market, including arteether, galantamine, nitisinone, and tiotropium, or are currently involved in late-phase clinical trials. As part of our National Cooperative Drug Discovery Group (NCDDG) research project, numerous compounds from tropical rainforest plant species with potential anticancer activity have been identified. Our group has also isolated several compounds, mainly from edible plant species or plants used as dietary supplements, that may act as chemopreventive agents. Although drug discovery from medicinal plants continues to provide an important source of new drug leads, numerous challenges are encountered including the procurement of plant materials, the selection and implementation of appropriate high-throughput screening bioassays, and the scale-up of active compounds.

Animals↗

Community participation in AIDS vaccine trials: empowerment or science?

For future AIDS vaccines to be successfully tested and implemented, extensive participation in vaccine trials will be necessary. Central to the challenges associated with such participation is concern for protection of participant wellbeing. This short report examines the tension that is sometimes found between the pragmatic need for recruitment into trials, and a more general social good concerning community participation in health. Community empowerment and trial participation are sometimes assumed to go hand in hand, but are potentially contradictory. Recognizing the possible disjunction between empowerment and trial participation allows for clearer discussion of and planning for ethical, scientifically valid trials.

AIDS Vaccines↗

Controller designs for constant cutting force turning machine control

A simulation study of a constant cutting force metal turning process is investigated. The process is a challenging control problem due to its nonlinear and time varying dynamics. Simulated implementations of PID, adaptive and non-adaptive sliding mode and model reference adaptive controllers were developed. Tests of the closed loop systems were performed for a range of cutting conditions including specific machined part contours that are presented here to verify the force tracking capability and flexibility of each control scheme. Results indicate that careful design and use of a fixed-gain sliding mode controller with output feedback can give roughly equivalent performance to that of more complex adaptive controllers.

Journal Article↗

Preventing chronic diseases in China.

Chronic diseases now account for an estimated 80% of deaths and 70% of disability-adjusted life-years lost in China. Cardiovascular diseases and cancer are the leading causes of both death and the burden of disease, and exposure to risk factors is high: more than 300 million men smoke cigarettes and 160 million adults are hypertensive, most of whom are not being treated. An obesity epidemic is imminent, with more than 20% of children aged 7-17 years in big cities now overweight or obese. The government of the People's Republic of China must confront these major challenges. The national cancer prevention and control plan (2004-10) is being implemented, and a national chronic disease prevention and control plan is due to be completed this year. Encouraging progress has been made in some areas, with current smoking prevalence in men declining at about 1% per year for a decade, and even better results in large demonstration programmes. Much remains to be done, and resources and sustainability are major issues. However, the surveillance and intervention mechanisms needed to ameliorate the increasing burden of chronic diseases are developing rapidly, taking account of the lessons learned over the past two decades.

Adolescent↗

Heart failure.

Heart failure is predominantly a disorder of older adults, and to a large extent the epidemiology of heart failure reflects the convergence of age-related changes in the cardiovascular system and the rising prevalence of age-related cardiovascular diseases. The diagnosis of heart failure in the elderly is often difficult because of the presence of atypical symptomatology and comorbid conditions. Similarly, optimal treatment frequently poses a therapeutic challenge because of the high prevalence of confounding medical, behavioral, psychosocial, and economic factors. In addition, there is a paucity of data on the pharmacotherapy of heart failure in the very elderly (over age 80), and in the large proportion of older patients with heart failure and preserved left ventricular systolic function. Despite these difficulties, a number of therapeutic options, including ACE inhibitors, digoxin, and possibly beta blockers and angiotensin receptor antagonists, have been shown to favorably affect the clinical course of heart failure in elderly patients. In addition, several studies have documented the efficacy of multidisciplinary heart failure disease management programs for reducing hospital admission rates, improving quality of life, and decreasing cost of care. At present, the three greatest challenges in managing older heart failure patients are: (1) to more effectively implement proven treatments, such as ACE inhibitors, disease management systems, and antihypertensive therapy; (2) to develop effective therapies for the treatment of diastolic heart failure; and (3) to develop more effective means for heart failure prevention. It is hoped that future studies will address each of these critically important issues.

Aged↗

From measurements of metabolites to metabolomics: an 'on the fly' perspective illustrated by recent studies of carbon-nitrogen interactions.

Techniques for surveying metabolite levels provide a powerful tool for basic plant research and biotechnology. They offer the possibility of specialised measurements of specific classes of metabolites, profiling of a very broad range of low molecular weight compounds, and resolving the spatial and/or temporal localisation of selected key metabolites. Recent applications in the field of carbon-nitrogen interactions provide a framework to discuss how metabolite datasets are being utilised in the post-genomic era to characterise system responses, link transcript data to phenotypic responses, analyse underlying regulation mechanisms, and implement an in-context analysis of gene function. A major future challenge concerns the integration of the information gained from metabolite profiling into an accessible body of knowledge.

Carbon↗

Schools and adolescent health: strengthening services and improving outcomes.

School-based health services have made limited contributions to the well-being of school-age children. However, they have the potential for promoting health and improving service delivery for 50 million children and adolescents enrolled in the nation's schools. Recent changes in health care, particularly the spread of managed care and development of integrated health service networks, have reawakened mainstream interest in school health and created the possibility for strengthening its efficiency and effectiveness. Two promising strategies for enabling school health programs to fulfill their potential are being implemented by the Massachusetts state government and by an Austin, Texas, hospital system. These strategies suggest measures to create either closely linked school and community health systems or fully integrated school/community child health systems that may have widespread benefit for children and their families. Barriers to fully implementing these strategies and replicating them in other communities will include the challenge of securing adequate funding, disagreements regarding the appropriate content of a school health program, and opposition to new staffing and employment arrangements from professional and union organizations. Whether this moment of opportunity yields gains for child health and school health will, for the most part, depend on forces outside school health. Success will be particularly dependent on the degree to which the managed care plans or large health care organizations see value in building more comprehensive child health systems or identify financial benefits from linking more closely with school-based services.

Adolescent↗

Adaptive calibration scheme for quantification of nutrients and byproducts in insect cell bioreactors by near-infrared spectroscopy.

Spectroscopic methods are gaining in popularity in biotechnology because of their ability to deliver rapid, noninvasive measurements of the concentrations of multiple chemical species. Such measurements are particularly necessary for the implementation of control schemes for cell culture bioreactors. One of the major challenges to the development of spectroscopic methods for bioreactor monitoring is the generation of accurate and robust calibration models, particularly because of the inherent variability of biological processes. We have evaluated several methods of building calibration models, including synthetic calibrations and medium spiking methods. The approach that consistently produced reliable models incorporated samples removed from a bioreactor that were subsequently altered so as to increase the sample variation. Several large volume samples were removed from a bioreactor at varying time points and divided into multiple aliquots to which were added random, known amounts of the analytes of interest. Near-infrared spectra of these samples were collected and used to build calibration models. Such models were used to quantify analyte concentrations from independent samples removed from a second bioreactor. Prediction errors for alanine, glucose, glutamine, and leucine were 1.4, 1.0, 1.1, and 0.31 mM, respectively. This adaptive calibration method produces models with less error and less bias than observed with other calibration methods. Somewhat more accurate measurements could be attained with calibrations consisting of a combination of synthetic samples and spiked medium samples, but with an increase in calibration development time.

Alanine↗