Structure, functions, and activities of a research support informatics section.
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The authors describe a research group that supports the needs of investigators seeking data from an electronic medical record system. Since its creation in 1972, the Regenstrief Medical Records System has captured and stored more than 350 million discrete coded observations on two million patients. This repository has become a central data source for prospective and retrospective research. It is accessed by six data analysts--working closely with the institutional review board--who provide investigators with timely and accurate data while protecting patient and provider privacy and confidentiality. From January 1, 1999, to July 31, 2002, data analysts tracked their activities involving 47,559 hours of work predominantly for physicians (54%). While data retrieval (36%) and analysis (25%) were primary activities, data analysts also actively collaborated with researchers. Primary objectives of data provided to investigators were to address disease-specific (35.4%) and drug-related (12.2%) questions, support guideline implementation (13.1%), and probe various aspects of clinical epidemiology (5.7%). Outcomes of these endeavors included 117 grants (including 300,000 US dollars per year salary support for data analysts) and 139 papers in peer-reviewed journals by investigators who rated the support provided by data analysts as extremely valuable. (+info)
Learning how scientists work: experiential research projects to promote cell biology learning and scientific process skills.
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Facilitating not only the mastery of sophisticated subject matter, but also the development of process skills is an ongoing challenge in teaching any introductory undergraduate course. To accomplish this goal in a sophomore-level introductory cell biology course, I require students to work in groups and complete several mock experiential research projects that imitate the professional activities of the scientific community. I designed these projects as a way to promote process skill development within content-rich pedagogy and to connect text-based and laboratory-based learning with the world of contemporary research. First, students become familiar with one primary article from a leading peer-reviewed journal, which they discuss by means of PowerPoint-based journal clubs and journalism reports highlighting public relevance. Second, relying mostly on primary articles, they investigate the molecular basis of a disease, compose reviews for an in-house journal, and present seminars in a public symposium. Last, students author primary articles detailing investigative experiments conducted in the lab. This curriculum has been successful in both quarter-based and semester-based institutions. Student attitudes toward their learning were assessed quantitatively with course surveys. Students consistently reported that these projects significantly lowered barriers to primary literature, improved research-associated skills, strengthened traditional pedagogy, and helped accomplish course objectives. Such approaches are widely suited for instructors seeking to integrate process with content in their courses. (+info)
Learning cell biology as a team: a project-based approach to upper-division cell biology.
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To help students develop successful strategies for learning how to learn and communicate complex information in cell biology, we developed a quarter-long cell biology class based on team projects. Each team researches a particular human disease and presents information about the cellular structure or process affected by the disease, the cellular and molecular biology of the disease, and recent research focused on understanding the cellular mechanisms of the disease process. To support effective teamwork and to help students develop collaboration skills useful for their future careers, we provide training in working in small groups. A final poster presentation, held in a public forum, summarizes what students have learned throughout the quarter. Although student satisfaction with the course is similar to that of standard lecture-based classes, a project-based class offers unique benefits to both the student and the instructor. (+info)
Overview of bladder cancer trials in the European Organization for Research and Treatment.
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In the 1990s, the European Organization for Research and Treatment of Cancer Genito-Urinary (EORTC GU) Group focused on dose-intensity concepts of the methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) regimen for patents with bladder cancer. In a randomized trial in patients with advanced urothelial cell cancer, standard MVAC was compared with 2-weekly intensified MVAC plus granulocyte-colony stimulating factor (G-CSF) support. Although the dose-intensified therapy resulted in a higher overall and complete response rates, it did not result in a better median survival. In parallel, the Spanish Oncology Genitourinary Group (SOGUG), in collaboration with the EORTC GU Group, conducted Phase I and II trials to investigate the feasibility and efficacy of the incorporation of two new active agents, gemcitabine and paclitaxel, into two-drug or three-drug cisplatin-based or carboplatin-based regimens. The EORTC GU Group currently is conducting randomized studies of combined paclitaxel, cisplatin, and gemcitabine compared with combined gemcitabine plus cisplatin in patients with good performance status and good renal function and studies of combined gemcitabine plus carboplatin compared with combined carboplatin, methotrexate, and vinblastine in patients who are unsuited for cisplatin. In the 1990s, the EORTC coordinated a large Intergroup study of neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy versus no chemotherapy before definitive treatment. That study included 976 patients and was based on a design to detect at least a 10% absolute improvement in survival. The final results showed a 5.5% survival difference at 3 years in the chemotherapy arm. The EORTC GU Group currently is coordinating an Intergroup study that was designed to detect an improvement of 7% in absolute survival in the adjuvant setting. Cancer 2003;97(8 Suppl):2120-6. (+info)
Rating the risk factors for breast cancer.
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OBJECTIVE: To update and summarize evidence of risk factors for breast cancer. SUMMARY BACKGROUND DATA: Women who are at high risk for breast cancer have a variety of options available to them, including watchful waiting, prophylactic surgery, and chemoprevention. It is increasingly important to accurately assess a patient's risk profile to ensure that the cost/benefit ratio of the selected treatment is favorable. METHODS: Estimates of relative risk for documented risk factors were obtained from seminal papers identified in previous reviews. These estimates were updated where appropriate with data from more recent reports using large sample sizes or presenting meta-analyses of previous studies. These reports were identified from a review of the Medline database from 1992 to 2002. RESULTS: Risk factors that have received a great deal of publicity (hormone use, alcohol consumption, obesity, nulliparity) present a relatively modest relative risk for breast cancer (<2). Factors associated with a prior history of neoplastic disease or atypical hyperplasia and factors associated with a genetic predisposition significantly affect the risk of breast cancer, with relative risks ranging from 3 (for some cases of positive family history) to 200 (for premenopausal women positive for a BRCA mutation). CONCLUSIONS: More precise tools, based on techniques of molecular biology such as microarray analysis, will be needed to assess individual risk for breast cancer. (+info)
Forum report: issues in the design of trials of drugs for the treatment of invasive aspergillosis.
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A recent trial of drugs for invasive aspergillosis was used as a background for discussing critical features in the design of antifungal trials. The study under discussion allowed stopping either drug without classifying the patient as having treatment failure, so the trial should be understood as a comparison of 2 treatment strategies, not just 2 drugs. Although the study was a noninferiority trial, the outcome permitted a claim of superiority. Use of the category of "probable" in addition to "proven" aspergillosis permitted inclusion of patients for whom the diagnosis was less certain but who were still early enough in the disease progression to respond to therapy. Different opinions still exist about some of the criteria for the diagnosis of "probable" aspergillosis. A blinded data review committee was helpful in evaluating efficacy in this unblinded trial but had limited value in assessing toxicity. An understanding of these features of design of antifungal drug trials is important in applying the results to clinical practice. (+info)
The future of GI and liver research: editorial perspectives: II. Modulating leukocyte recruitment to splanchnic organs to reduce inflammation.
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A hallmark feature of intestinal inflammation is the recruitment and extravasation of numerous cell types from the blood to the afflicted site. Much of what we know about the mechanisms of leukocyte recruitment to splanchnic organs comes from an extensive series of studies on neutrophils in the mesenteric microvasculature. In this themes article, we highlight the important findings from these experiments but also emphasize some of the limitations. In fact, there is a growing body of evidence that neutrophil recruitment may be quite different in the mesentery than in other splanchnic organs. For example, the molecular mechanisms underlying neutrophil recruitment into the liver are quite different than the mesentery and are dependent on the type of inflammatory disease. We also discuss the effect of modulating leukocyte recruitment to splanchnic organs in chronic inflammation and emphasize that the approaches that have been successful in acute inflammation may be less effective in such conditions as inflammatory bowel disease (IBD). One obvious reason for this observation is the growing body of evidence to suggest that the initiation and maintenance of IBD is, in part, due to dysregulated or inappropriately activated populations of infiltrating T lymphocyte subsets. Therefore, we also discuss some interesting new approaches to limiting lymphocyte recruitment into the inflamed intestine either by targeting T helper (Th)1 vs. Th2 lymphocytes or perhaps by allowing the recruitment of regulatory T cells. Inhibiting specific adhesion molecules or specific chemokine receptors may work in this regard. (+info)
Patients' willingness to participate in symptom-related and disease-modifying research: results of a research screening initiative in a palliative care clinic.
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BACKGROUND: The growth of cancer symptom management research has been limited by challenges of slow recruitment and under-enrollment. One potential solution to this problem is the use of screening questions that identify patients who are interested in participating in research. The goal of this study was to evaluate this strategy in patients with cancer. METHODS: Two screening questions (for symptom management research and disease-modifying research) were integrated into the intake process of the palliative care clinic of an urban Veteran's Administration medical center. A chart review was conducted to extract patients' reported willingness to be recruited for research, explanations for their responses, demographic data, Memorial Symptom Assessment Scale Global Distress Index (GDI) subscale scores, and Eastern Cooperative Oncology Group performance score. RESULTS: Charts were reviewed for the first 100 patients seen for a palliative care clinic visit, 86 of whom had cancer. Patients were less likely to be interested in symptom-related research than in disease-modifying research (32 of 86 [37%] vs. 46 of 86 [54%]; sign test, P = 0.009). Patients' interest in each type of research was associated moderately (kappa = 0.41; P < 0.001). Independent predictors of interest in symptom management research included younger age, white race, and a lower GDI symptom distress score. Independent predictors of interest in disease-modifying research included only younger age and white race. CONCLUSIONS: Screening questions may be useful in identifying patients who are willing to be recruited for research. However, further study is needed to evaluate this process in other populations, as well as to determine whether screening questions introduce selection bias in the recruitment process. (+info)