Nephrology Research Training Program

Transcription

1 Nephrology Research Training Program A. Research fellowship curriculum for fellows on 3-year research fellowship (1) Research Sites Basic or clinical research are conducted at the VA or at University Hospital, depending upon the location of the mentor. (2) Research Schedule - Research fellows identify a mentor within the first month of their fellowship. Depending upon the fellow's preference and the number of clinical fellows, the research fellow will do their clinical year either at the beginning or the end of their fellowship. Once the fellow starts in the laboratory, they will do this exclusively for two years with the exception that they will maintain a ½-day general nephrology continuity clinic throughout their entire fellowship. (3) Goals and Objectives of Research Program a. Understand fundamentals of basic or clinical research. For both clinical and basic research, this includes research design and data analysis (biostatistics). For clinical research, this also includes public policy, economics, health education, designing trials, recruiting subjects and other epidemiology issues, and outcomes analysis. b. Gain hands-on experience with conducting a basic or clinical research project including research design (where feasible), conducting the study, data analysis, and manuscript preparation. It is expected that the fellow will generate at least one peer-reviewed original research publication from this work, although this is not a requirement for graduation from the program. c. Understand principles of grant writing. d. Provide sufficient experience in basic or clinical research to allow Fellows to make an informed decision about their academic career choices. e. Provide sufficient exposure to basic or clinical research to allow Fellows to interpret basic and clinical research literature. (4) Educational Training a. Didactic courses 1. Clinical Research Training Track for Physician-Scientists. All fellows engaging in clinical research are given the option to enroll in the Masters of Science in Clinical Investigation (MSCI) at the University of Utah. The MSCI is a two-year post-graduate experience that emphasizes epidemiology, clinical outcomes, clinical trials and health services research. The MSCI is funded by a Clinical and Translational Scientist Award (CTSA) of the NIH. Additional funding to support the program is provided by the Vice President for Health Sciences. The program is composed of formal didactic coursework, a longitudinal seminar series, and a mentored clinical research project. Fellows who successfully complete the program are eligible for a Master s Degree awarded by the School of Medicine. Fellows successfully completing the program are awarded a Master s Degree in Clinical Investigation. This degree is offered by the General Clinical Research Center, which has been designated as a degree-granting academic department within the SOM. The academic year for the TPCI program begins the second week of July and runs through the last week in May. The curriculum during Year 1 of the MSCI program begins with a six-week intensive block of didactic course work and workshops (Schedule A). Fellows take a set of core courses in epidemiology, data management, bioethics, biostatistics and the research seminar series. Workshops in grant writing and the preparation of clinical research protocols are also offered. The curriculum focuses on community intervention studies, an epidemiology seminar and a computer practicum. During the six-week intensive block, the renal fellow will design and initiate their research project in conjunction with their preceptor. Advanced, didactic coursework is continued through the fall and spring semesters (Schedule A). Courses are given two afternoons each week or in brief blocks over Thursday, Friday and Saturday morning. The mentor-based clinical research project continues. During the second year effort is focused on the clinical research project. However, during the fall semester of the second year, all fellows are required to take a 1

2 weekly one-hour course entitled "Scientific Integrity & Ethics of Scientific Research". This course meets federal requirements for training grants and is described below. During the late fall semester or early spring semester of the second year of the MSCI program, fellows will prepare (with the aid of his/her mentor) an application for a career development award through the NIH, the Department of Veterans Affairs, or an appropriate professional society. At the conclusion of the second year, a master s thesis is submitted which can also serve as a research paper of publishable quality. Throughout the two-year program, fellows are required to attend a longitudinal research seminar series, given on two Friday afternoons per month. This series covers a wide variety of subjects of interest to students and also provides an opportunity for camaraderie amongst all MSCI participants, not just those in the Nephrology Training Program. All enrollees to date have ample time during the two years to complete their clinical research projects and to be highly competitive for NIH funding. Fellows will be expected to participate by presenting their research at these research conferences as described above. Fellows will attend the annual American Society of Nephrology meeting each of these two years and will be expected to present their research at this meeting during the third year. Fellows also will be encouraged to present their research at the annual National Kidney Foundation meeting as well as any relevant regional conferences. Schedule A. Training program in clinical research curriculum INITIAL MDCRC 6010 Introduction to Epidemiology. Covers the basics of epidemiology BLOCK including: measures of disease frequency, measures of effect, basic study designs, (6 confounding bias, stratification, and causal reasoning. This course is presented in two-hour weeks) sessions, two days a week for the first three weeks of the block. MDCRC 6020 Data Management. Covers managing databases for research, including problems and solutions for data management, database design, table linkage, confidentiality issues and data security. The course is presented in six two-hour sessions. MDCRC 6430 Bioethical Issues in Clinical Research. Ethical issues and standards for scientific investigation are covered in depth. Course- work emphasizes the history and evolution of research norms and practices, institutional expectations and standards, and the process of review and oversight for experimental protocols. Additional material covers ethical issues and public policy linked to genetic research. Case-based problem solving is used to cover interactions with the Institutional Review Board. This course is presented in two hour blocks, once weekly. MDCRC 6000 Introduction to Biostatistics. Basic statistics with emphasis on medical and epidemiologic research problems, including description of data, theoretical distribution, experimental design, hypothesis testing, comparison of groups, correlation, confidence intervals and sample size estimation. This course is presented in two-hour blocks, once weekly. MDCRC 6410 Research Seminar Series. This course is presented during the intensive introductory course and throughout the fall and spring. The course is presented for two hours on every Friday afternoon throughout the intensive introductory course and on the second and fourth Fridays of the fall and spring semester. Each seminar begins with the presentation of a clinical issue related to health care delivery or epidemiology. Discussions follow based on the methods used for defining epidemiologic and other health care issues. The seminars are designed to illustrate the process of scientific discovery in clinical investigation, provide examples of how innovative approaches and methods were applied and to discuss obstacles that impede progress. Visiting faculty from other universities participate in the seminar series. MDCRC 6100 Epidemiology Seminar. Key papers describing epidemiological methods are discussed followed by critical reviews of representative studies illustrating the application of these methods. This course is presented in two two-hour blocks each week for the first three weeks. 2

3 FALL YEAR ONE SPRING YEAR ONE MDCRC 6030 Computer Practicum. This course is designed to afford hands-on practice with statistical software (e.g. Stata). Students learn to merge databases, analyze data, scientific graphing, Monte Carlo simulation, and sensitivity analysis. This course is offered in two-hour blocks twice weekly during the last three weeks. MDCRC 6040 Design and Implementation of Clinical Trials. This course defines clinical trials and reviews drug registration trials, phase I, II and III trials, clinical endpoints, surrogate endpoints, pharmacokinetics, drug-drug interactions, data and safety monitoring, criteria for closure and single versus multi-institutional trials. Casebased sessions covering clinical trials in occlusive heart disease, arthritis, asthma and oncology provide informative examples of trial design and potential pitfalls. This course is presented in a weekly two- hour block. MDCRC 6240 Community Intervention Studies. Strategies are presented for designing and implementing field intervention trials. Methods of analysis are covered, including cluster randomization and time series analysis. This course is presented as a one day intensive experience totaling 8 hours of lectures and tutorials. MDCRC 6230 Health Services Research. This course focuses on measurement of clinical outcomes and includes scale development, reliability and validity, study design, misclassification bias, co-morbidity, severity of illness scores, organizational structure and quality of life measurements. The course is taught as 3 intensive 1- day blocks every 2 months. MDCRC 6130 Introduction to Decision Analysis. This course serves as an introduction to the subject of decision analysis related to health care and includes concepts, creation and evaluation of decision trees, Markov chains, sensitivity analysis and incorporation of patient preferences with utility analysis. This course is presented as a two and one-half day intensive experience totaling sixteen hours of lectures and tutorials. MDCRC 6120 Cost Effectiveness Analysis. The material presented covers concepts used in the economic evaluation of health care programs, foundations of cost effectiveness analysis, interpreting and critiquing the literature of cost-effective analysis, and constructing these analyses. This course is presented as a two and one-half day intensive experience totaling sixteen hours of lectures and tutorials. OPTIONAL MDCRC 6110 Intermediate Epidemiology. Students enrolling in this course must have completed MDCRC 6010, Introduction to Epidemiology. Intermediate Epidemiology covers research design and conduct of epidemiologic studies, including assessing effect modification, stratification, matching, sampling and reasoning with causal diagrams. This course is presented in a weekly two- hour block during the second six weeks. OPTIONAL MDCRC 6140 Intermediate Decision Analysis. Students enrolling in this class are required to have completed MDCRC 6130, Introduction to Decision Analysis. The intermediate decision analysis course is a practicum in designing and constructing a decision analysis model to solve an actual health care problem. A problem is provided and students are instructed in methods to solve the problem utilizing decision analysis. This course meets in two one-day blocks, each eight hours in duration. In the first block the problem is presented; in the second block students present their solution to the problem. MDCRC 6200 Meta Analysis. This focuses on the meta-analysis approach combining quantitative data. Subjects covered include statistical methods, eligibility criteria of studies, tests of homogeneity, summary measures, sources of variation and sensitivity analysis. This course is presented in a weekly two-hour block throughout the last six weeks. OPTIONAL MDCRC 6210 Regression Models. Students enrolling in this course must have completed MDCRC 6000, Introduction to Biostatistics and MDCRC 6010, Introduction to Epidemiology. The course in regression models covers linear regression, logistic regression, Poisson regression, Cox regression, and includes methods for correlated 3

4 FALL YEAR TWO data (generalized estimating equations and mixed models), testing model assumptions, and assessment of model fit. This course is presented in a weekly two-hour block. MDCRC 6220 Survey Methods. Students must have completed MDCRC The course on survey methods covers the design and analysis of surveys, including questionnaire development, sample designs, stratification, clustering, multi-stage sampling, and the analysis of data generated from these complex designs. This course is presented as a two and one-half day experience totaling sixteen hours of lectures and tutorials. OPTIONAL INT MD 7570 Scientific Integrity & Ethics of Scientific Research. The course meets federal ethics requirements for training grants. The series covers topics of general interest in ethics and science. Topics include the norms of scientific inquiry and the nature of scientific misconduct; conflicts of interest (including the university policy); intellectual property and technology transfer; responsible authorship and editorial policies; and protection of research subjects and research with animals. Sessions are panel discussions featuring responsible administrators, scientists and physicians from a wide range of disciplines, and faculty in philosophy and law. The course meets 12 times during the fall semester and each meeting lasts for 1 hour. Course coordinator is Leslie Francis, Professor of Philosophy and Law. 2. Division of Nephrology Statistics course Fellows attend 10 two-hour sessions held on Thursdays from 4:30-6:30 PM dedicates to understanding medical statistics. The course is taught by members of the nephrology division as well as University of Utah statisticians. 3. Division of Nephrology Clinical Research course Fellows interested in clinical research, but not enrolled in the CTSA program, attend a one-hour session each month devoted to understanding basics of research design, data analysis (biostatistics), public policy, economics, health education, designing trials, recruiting subjects and other epidemiology issues, and outcomes analysis. The course is run by Dr. Beddhu and is largely based on the JAMA publications devoted to these areas. 4. Fellows engaging in basic research will be required to take the Basic Research in Nephrology Curriculum. This curriculum involves required core and elective courses. Core courses are taken during the first year and involve training in biostatistics (MDCRC 6000) (Schedule A), scientific integrity and ethics of scientific research (INT MD 7570) (Schedule A), and basic research techniques. Since every basic research laboratory utilizes some degree of physiologic, cell biologic, and molecular biologic techniques, fellows will be given the option to take core courses in these areas (Schedule B). In addition, they may take a course on scientific lecturing and writing (Schedule B). Depending upon the nature of the basic research project, fellows will be offered courses on an elective basis. While multiple courses exist, given the Nephrology Training Program research activities, it is anticipated that they will most likely take one or more of the courses described in Schedule C. These courses are intended to supplement learning that occurs in the laboratory due to interactions with the preceptor, collaborators, and laboratory members. During the fall and spring semesters of year 2 of research training (depending on the application due date), trainees will apply for mentored research grants, such as an NIH K08, an American Heart Association Scientist Development Grant, or similar funding. Schedule B. Basic research core courses. FALL BLCHM 6400 Genetic Engineering. This course covers essential techniques used in genetic engineering. Topics include the use of restriction endonucleases, amplification of YEAR ONE DNA sequences using PCR, Southern and Northern blotting, properties of cloning vectors and their use in constructing genomic and cdna libraries, DNA sequencing and sequence analysis, creating and detecting mutations in DNA and introducing these mutations into a genome (transgenic and knockout models), and expression of proteins. Held in 2-hour weekly sessions. FALL AND PHYS 7910 Practicum in Physiology. A laboratory-oriented practicum emphasizing 4

5 SPRING YEAR ONE FALL YEAR TWO the practice of physiological technique as it pertains to specific research problems. Course covers membrane models, ion selectivity, intracellular ph and Ca 2+ regulation. Recording surface potentials, ionic currents, nerve discharge and documentation of nervous activity with antibody markers are taught. The second half of the practicum emphasizes assays involving antibodies including receptor binding, and radio immunoassays. Microfluorometric analysis, confocal microscopy, in-vivo drug assay and genetic markers in disease are given practical consideration. Held in three hour sessions once a month. ANAT 7790 Fluorescence Microscopy and Digital Imaging. Laboratory and lecture course of basic and advanced microscopic techniques. Phase contrast, fluorescence, and confocal microscopy. Digital image-processing, quantitative analysis, and production of publication-quality images. Held in 1-hour sessions once a month. ANAT 7690 Scientific Lecturing and Writing. Course teaches guidelines for writing clear scientific papers and delivering good lectures. Lectures, discussion, homework assignments and submission of a new original scientific paper in an area chosen by each student. Held in hourly sessions once a month. Schedule C. Selected highly relevant basic research courses Physiology PHYS 6010 Systemic Physiology II. Must have had basic physiology. Emphasizes physiological principles of major organ systems. Three hours weekly in fall semester. Molecular Biology Cell Biology MBIOL 6420 Genetics and Genome. The Genetics and Genomes course covers the basic principles of genetics in both prokaryotes and eukaryotes, and the basic mechanisms of genome structure and replication. Mechanisms governing the transmission of genetic information are covered in bacteria, fungi, flies, worms, and vertebrates, including mutagenesis, transposons, suppression, epistasis, recombination, mosaics, gene knockouts, and two hybrid analysis. The genomes section of the course covers the organization of genes on chromosomes, chromatin structure, DNA replication and repair, gene silencing, chromosome inactivation, imprinting, and genome evolution. Three hours weekly in fall semester. MBIOL 6440 Gene Expression. This course covers transcriptional and posttranscriptional mechanisms of gene regulation. Lectures cover recent advances in these fields with material based on the primary literature. The transcriptional regulation section of the course covers, basic mechanisms of gene activation and repression, chromatin remodeling machines, regulation of transcription activation by signal transduction cascades. The post-transcriptional section covers mechanisms regulating RNA processing (splicing, editing, and transport), translation and mrna stability. Three hours weekly in spring semester. MBIOL Cell Biology II. Must have had basic cell biology. The course covers: 1. cell structure/function and intracellular trafficking. 2. Signal transduction, cell cycle and apoptosis. 3. Cell-cell communication, differentiation and tissue maintenance. Each section consists of a series of lectures that explore the basic concepts associated with the various topics. Each section has an in class exam and a writing assignment in the form of a mini grant proposal that encourages the identification of important scientific problems and the formation of a testable hypothesis, the creation of a research plan to test the hypothesis and the presentation of this material in an acceptable and persuasive format. 3 hr weekly in fall semester. b. The research mentor-fellow relationship is the primary means by which Fellows will achieve training in basic or clinical research. (5) Nature of Supervision - Fellows should select a project and mentor by September 1 of the first year of Fellowship and inform the Nephrology Fellowship Program Director of their selection. For the next 23 months, the Fellow s research activities will be guided by the Mentor. This involves frequent meetings (at least bi-weekly during the two years of research). 5

6 (6) Means of Fellow Evaluation The mentor provides the Fellow with ongoing informal feedback. In addition, the mentor meets with the Nephrology Training Program Director semiannually to report on the Fellow s progress. The Training Program Director also discusses the research progress with the Fellow during quarterly meetings between the Research Fellow and the Training Program Director. Fellows are expected to be a first author on at least one publication in a peer-reviewed journal. In addition, they are expected to present their research at least once annually at national meetings. B. Clinical research curriculum as part of 2-year clinical fellowship (1) Research Sites Clinical research is conducted primarily when the Fellows are on the OP rotation. The OP service, which comprises three months each year, allows a substantial amount of time for research, without having inpatient responsibilities. Additionally, several opportunities exist for Fellows to become involved in ongoing multicenter collaborations. (2) Research Schedule - Within the first month of Fellowship, Fellows meet with all clinical research faculty to discuss possible clinical research projects and mentorship. Basic research projects are not realistic during the two years of Fellowship. Fellows are expected to become involved in projects already in progress and not to be responsible for designing a new project. Fellows are not expected to obtain independent funding to support their salary or research activities. After identifying a mentor and project, Fellows are actively involved in the faculty-directed clinical research project while on each OP rotation. (3) Goals and Objectives of Research Program a. Understand fundamentals of clinical research including basics of research design, data analysis (biostatistics), public policy, economics, health education, designing trials, recruiting subjects, responsible use of informed consent, standards of ethical conduct of research, clinical epidemiology, and outcomes analysis. b. Gain hands-on experience with conducting a clinical research project including research design (where feasible), data analysis, subject recruitment, data collection, and manuscript preparation. c. Understand principles of grant writing. d. Provide sufficient exposure to clinical research to allow Fellows to make an informed decision about pursuing a career involving clinical research. e. Provide sufficient exposure to clinical research to allow Fellows to critically assess clinical research literature and to be competent in using available medical informatics systems. Bibliographic retrieval and critical appraisal skills are of paramount importance. f. Become a co-author on a published manuscript or abstract, or present research at a national meeting. (4) Educational Training a. Didactic courses 1. CRC course - Fellows interested in clinical research attend a 2-day general clinical research course given in August of their first year by the Clinical Research Center at the University of Utah. Topics covered include basics of research design, ethical conduct of research, responsible used of informed consent, data analysis (biostatistics), public policy, economics, health education, designing trials, recruiting subjects and other epidemiology issues, and outcomes analysis. 2. Division of Nephrology Clinical Research course Fellows attend 8 one-hour sessions over the course of each year devoted to understanding clinical research. The course is taught by Dr. Beddhu. Details are discussed in Section 7E above. b. The research mentor-fellow relationship is the primary means by which Fellows will achieve training in clinical research. (5) Nature of Supervision - Fellows should select a project and mentor by September 1 of the first year of Fellowship and inform the Nephrology Fellowship Program Director of their selection. For the next 22 months, the Fellow s clinical research activities will be guided by the Mentor. This involves frequent meetings (at least every two weeks during the OP rotation and every two 6

7 months during other rotations) between the Fellow and mentor during which all aspects of conducting the clinical research projects are addressed. (6) Means of Fellow Evaluation The mentor provides the Fellow with ongoing informal feedback. In addition, the mentor meets with the Nephrology Training Program Director semiannually to report on the Fellow s progress. The Training Program Director also discusses the research progress with the Fellow during their semi-annual meetings. Evidence of successful completion of the Fellow research requirement includes presenting an abstract at a national or regional meeting, publishing an abstract or manuscript, and/or presentation of the research to the Division of Nephrology for the one hour research conference. 7