Division of Nephrology Fellowship Program Guide

Transcription

1 Division of Nephrology Fellowship Program Guide

2 University of Utah Nephrology Fellowship Program Introduction... 3 Fellow Selection Policy/Process... 3 Nephrology Fellowship Program Training Sites... 4 Inpatient Sites... 4 Outpatient Sites... 4 Nephrology Training Program Schedule... 5 Division of Nephrology Faculty Members... 8 Nephrology Clinical Training Program Curriculum Clinical Curriculum Introduction Core competencies Progressive objectives Nephrology Research Training Program Clinical research curriculum as part of 2-year clinical fellowship Research fellowship curriculum for fellows on 3-year research fellowship Schedule A. Training program in clinical research curriculum Schedule B. Basic research core courses Guidelines for Promotion and Graduation Nephrology Fellowship Work, Duty Hours, Moonlighting and On-Call Policy Nephrology Fellow Stipend and Benefits Nephrology Fellows: Current and graduates in previous ten years... 25

3 Introduction (RETURN TO TABLE OF CONTENTS) The University of Utah Nephrology Fellowship Program is dedicated to providing the highest quality clinical and research training in the subspecialty of Nephrology. It is accredited by the Graduate Medical Education Committee of the University of Utah and by the Residency Review Committee of the ACGME. There are two programs: 1) The two-year Clinical Program - based at the University Hospital, Huntsman Cancer Hospital and the Salt Lake Veterans Affairs Medical Center. Upon completion, Fellows are board eligible in Nephrology. This program provides primarily clinical training; however, in addition to excellent clinical training, the University of Utah Nephrology Clinical Fellowship Program is designed to provide experience in clinical research. Fellows may opt to participate in either on-going faculty clinical research projects or develop related research interests of their own. 2) The three-year Research Program - involves one year of clinical training and two years of basic or clinical research. The clinical year may be done at the beginning or the end of the fellowship and is structured identically to the clinical experience of a year in the two-year clinical fellowship. The two years of research are spent under the direction of a faculty member within the Division of Nephrology. This guide provides comprehensive information about all aspects of the Program, including: Goals and objectives Nature of sites where training is performed Types of clinical encounters Patient case-mix characteristics Procedures and services Educational activities and resources, including didactic training and conferences Nature of supervision and evaluation of fellow s performance Faculty research activities Fellow research opportunities and policies On-call and vacation policies Former Fellow information Fellow selection policy Fellow Selection Policy/Process (RETURN TO TABLE OF CONTENTS) To be eligible for a fellowship in the Division of Nephrology at the University of Utah School of Medicine, an applicant must: 1. Be a graduate of a U.S. or Canadian medical school accredited by the Liaison Committee on Medical Education (LCME) and have 3-years residency in an ACGME-approved program, OR 2. Be a graduate of a college of osteopathic medicine in the United States accredited by the American Osteopathic Association (AOA) and have 3-years residency in an ACGME-approved program, OR 3. Be a graduate of a medical school outside of the United States who meets one or more of the following qualifications: 4. Has a currently valid ECFMG certificate plus at least one year training in an ACGME approved program, OR 5. Has a full and unrestricted license to practice medicine in a US licensing jurisdiction plus at least one year training in an ACGME-approved program, OR 6. Is a graduate of a medical school outside the United States who has completed a Fifth Pathway program provided by an LCME-accredited medical school. a. Be eligible for American Board of Internal Medicine prior to the time they begin training The Division of Nephrology requires the following documentation for application: 1. Completed fellowship application through ERAS 2. Curriculum Vitae and Personal Statement through ERAS 3. Three letters of recommendation through ERAS 4. International Medical Graduates must include the following in addition to the above: 3

4 a. Copy of green card, visa (J-1), or documentation of U.S. citizenship b. Valid ECFMG certificate with Clinical Skills Assessment certification c. Evidence of previous training in the United States Selection Criteria for Interviewing Applicants The Nephrology faculty, in a joint meeting, reviews applicants who meet the criteria. Based on the quality of the application and academic credentials, the applicant is subsequently invited for an interview. On the interview day, applicants receive an information packet and interview with members of the Division of Nephrology and current Nephrology fellows. At the conclusion of the interview, the interviewers complete a standard evaluation form for each applicant they interviewed. The results are tallied and form the basis of the preliminary rank order. The University of Utah Nephrology program participates in the National Residency Matching Program (NRMP, aka the Match ) for all entering fellows. We do not offer out-of-match positions. Nephrology Fellowship Program Training Sites (RETURN TO TABLE OF CONTENTS) Inpatient Sites 1. University Hospital (UH) - This is a tertiary care facility with 528 operating beds located on the University of Utah Health Sciences Center Campus. It contains surgical, neurosurgical, burn, and medical intensive care units; a newly remodeled 5-station acute dialysis unit with support for hemodialysis, peritoneal dialysis, therapeutic apheresis and continuous renal replacement therapies; radiologic services with modern renal-related procedures and diagnostic vascular and radionucleotide imaging; electron microscopy for renal biopsy material; biochemical and serologic laboratories; a nutrition support service; and relevant social services. A close working relationship exists with other services including surgery, urology, obstetrics, gynecology, neurology, cardiology, rheumatology, pediatrics and psychiatry. 2. Salt Lake Veterans Affairs Medical Center (VAMC) This is a tertiary care facility with 121 operating beds located adjacent to the University of Utah Lower Campus and approximately one-half mile from University Hospital. It contains surgical and medical intensive care units, a 10-station newly remodeled dialysis unit that performs acute and chronic hemodialysis and supports continuous renal replacement therapies and peritoneal dialysis, radiologic services with modern renal-related procedures and diagnostic vascular and radionucleotide imaging, electron microscopy for renal biopsy material, biochemical and serologic laboratories, a nutrition support service, and relevant social services. A close working relationship exists with other services including surgery, urology and psychiatry. 3. Huntsman Cancer Institute (HCI) This tertiary care facility has been designated as a Comprehensive Cancer Center by the National Cancer Institute and is among the top cancer centers in the world. A close working relationship and collaboration exists with the hematology/ oncology services. Outpatient Sites 1. University Hospital Renal Clinic Located on the A level of the University Hospital, this 11-room clinic is the site for all general nephrology, nephrolithiasis, post-transplant and pre-transplant patients associated with the University of Utah. 2. University of Utah Peritoneal Dialysis Clinic Located in Research Park 3. VAMC General Nephrology Clinic Located on the 4th floor of Building 1 (main hospital building) at the VAMC, this clinic is the site of ambulatory care for VA general nephrology, preand post-transplant patients. 4. VAMC Dialysis Clinic Located within the dialysis unit, this clinic is the site of outpatient follow-up of VA hemodialysis, peritoneal dialysis and post-transplant patients. 4

5 Nephrology Training Program Schedule (RETURN TO TABLE OF CONTENTS) The two-year clinical fellowship and the one clinical year of the research fellowship are comprised of four major rotations that cycle throughout the year. The following schedules are based on the Program s current policy of having four fellows (A through D below) doing clinical service together. Yearly schedule for fellows on clinical service (only 1 year for research fellows) Year 1 (1 block = 4 weeks) U=University Hospital; VA=VA Hospital; OP=Outpatient; TP=Transplant Block U A B C D A B C D A B C D A VA B C D A B C D A B C D A B OP C D A B C D A B C D A B C TP D A B C D A B C D A B C D Year 2 (1 block = 4 weeks) U=University Hospital; VA=VA Hospital; OP=Outpatient; TP=Transplant Block U A B C D A B C D A B C D A VA B C D A B C D A B C D A B OP C D A B C D A B C D A B C TP D A B C D A B C D A B C D University Hospital (3 months yearly) Monday Tuesday Wednesday Thursday Friday 8 AM General Ward duties Ward duties General Ward duties 9 AM Nephrology (All day) (All day) Nephrology 10 AM continuity clinic continuity clinic at U of U at U of U (Fellow 11 AM (Fellow Group A) Group B) Didactics (11:30-12:30) Noon Ward duties Signout (12:30-1:00) 1 PM Pathology conference (1:00-2:00) 2 PM 3 PM 4 PM Clinical conference 5 PM Research conference VA Hospital (3 months yearly) Monday Tuesday Wednesday Thursday Friday 8 AM General HD Rounds/ HD Rounds/ General Ward duties 9 AM Nephrology Ward duties Ward duties Nephrology 5

6 10 AM continuity clinic continuity clinic 11 AM at U of U at U of U (Fellow Group A) (Fellow Group B) Didactics (11:30-12:30) Noon 1 PM HD Rounds/ Ward duties VA Nephrology Consult clinic (12:30 pm) 2 PM 3 PM 4 PM Clinical conference 5 PM Research conference HD Rounds/ Ward duties Signout (12:30-1:00) Pathology conference (1:00-2:00) Outpatient nephrology and research (3 months yearly) Monday Tuesday Wednesday Thursday Friday 8 AM General Research/ General U of U GN clinic 9 AM Nephrology QIP VA PD Clinic Nephrology 10 AM continuity clinic or continuity clinic at U of U at U of U (Fellow 11 AM Transplant (Fellow Group A) Group B) Clinic Noon Research /QIP VA Nephrology follow-up clinic (Starts Research/QIP Research Didactics (11:30-12:30) 1 PM Signout (12:30-1:00) at 12:30 pm) 2 PM Pathology conference (1:00-2:00) 3 PM 4 PM Clinical conference 5 PM Research conference Transplant nephrology at University Hospital (3 months yearly) Monday Tuesday Wednesday Thursday Friday 8 AM General Posttransplant Pre-transplant General Inpatient 9 AM Nephrology clinic Nephrology transplant 10 AM continuity clinic GN clinic continuity clinic at U of U at U of U (Fellow 11 AM (Fellow Group A) Group B) Didactics (11:30-12:30) Noon Inpatient transplant Inpatient transplant Inpatient transplant Inpatient transplant Signout (12:30-1:00) 6

7 1 PM Pathology conference (1:00-2:00) 2 PM 3 PM 4 PM Clinical conference 5 PM Research conference 7

8 Division of Nephrology Faculty Members Name Jo Abraham, MD, MPH Clinical Assistant Professor Director, Nephrology Fellowship Program (RETURN TO TABLE OF CONTENTS) Interests Clinical trials in hypertension glomerulonephritis and CKD Adhish Agarwal, MD Assistant Professor Clinical care & Outcomes Research Faris Ahmed, MD, FASN Clinical Assistant Professor Clinical transplant nephrology Laith Al-Rabadi, MD Clinical Assistant Professor Glomerular Diseases, Clinical care Clinical transplant nephrology Srinivasan Beddhu, MD Professor Randomized trials and epidemiology of CKD and dialysis patients Alfred K. Cheung, MD Professor Chief, Division of Nephrology Clinical trials in CKD, dialysis and hypertension; vascular access basic science lab Epidemiology in CKD and dialysis Monique E. Cho, MD Assistant Professor Metabolic and cardiac complications of CKD Martin C. Gregory, MD, PhD. Clinical Professor Alport Syndrome Isaac Hall, MD Assistant Professor Kidney transplant predictors & outcomes Acute kidney injury Yufeng Huang, MD, PhD. Research Associate Professor Pathogenesis of diabetic nephropathy and kidney fibrosis Bellamkonda Kishore, MD, PhD. Research Professor Donald E. Kohan, MD, PhD. Professor Purinergic regulation of renal function, pathology and experimental therapies Hypertension, Renal physiology, Ion transport Polycystic kidney disease Man Li, PhD. Assistant Professor Genetic epidemiology of kidney function and CKD

9 Marcus Pezzolesi, PhD, MPH Assistant Professor Diabetic nephropathy, genetics, kidney disease Nirupama Ramkumar, MD, MPH Assistant Professor Renin angiotensin system, hypertension, Ion transport, renal physiology Aylin Rodan, MD, PhD Assistant Professor Ion Transport, Renal Physiology, Potassium Homeostasis Kalani Raphael, MD, MS Associate Professor Chronic kidney disease outcomes Acidosis and CKD progression Fuad Shihab, MD Clinical Professor Chronic cyclosporine nephropathy Renal transplantation outcomes Biomarkers in kidney transplants Yan-Ting Shiu, PhD. Research Associate Professor Biophysics of vascular access stenosis Ets-1 in vascular biology Christi Terry, PhD. Research Associate Professor Adipokines in the vasculature Vascular access stenosis and development Christof Westenfelder, MD Professor Chief, Renal Section VA Salt Lake City Healthcare System Stem cells in acute kidney injury Renal actions of erythropoietin Tianxin Yang, MD, PhD. Professor PPAR gamma, obesity, clock genes Collecting duct signaling Off-campus faculty Marcellus Assiago, MD Clinical Assistant Professor Clinical care in Southern Utah Terrence Bjordahl, MD Clinical Assistant Professor Clinical care in Salt Lake City Yaw Boateng, MD, PhD Clinical Assistant Professor Clinical care in Southern Utah 9

10 Scott Eppich, MD Staff Physician Clinical care in Utah County Nasimul Ghani, MD Staff Physician Clinical care in Idaho Falls, ID Arsalan Habib, MD Clinical Assistant Professor Associate director, Off campus operations Clinical care in Salt Lake City Bruce Horowitz, MD Clinical Professor Clinical care in Northern Utah and VA Siddhartha Kakani, MD, MHA Staff Physician Clinical care in Utah County Andrea Nelson, MD Clinical Instructor Clinical care in Salt Lake City Abinash Roy, MD Clinical Associate Professor Clinical care in St. George, UT Harry Senekjian, MD Clinical Assistant Professor Clinical care in Northern Utah Girish Singhania, MD Clinical Assistant Professor Clinical care in Northern Utah Robert Yenchek, MD Clinical Assistant Professor Clinical care in Salt Lake City Tahir Zaman, MD Clinical Instructor Clinical care in Salt Lake City 10

11 Nephrology Clinical Training Program Curriculum (RETURN TO TABLE OF CONTENTS) Clinical Curriculum Introduction The Nephrology Fellowship Clinical Training Program is designed to provide individuals with the opportunity to achieve the fundamental knowledge, procedural skills, practical experience, and professional and ethical behavior necessary for the subspecialty of Nephrology. Fellows care for patients with the full spectrum of renal disorders at all stages of the disease process. Efforts are made at every point to emphasize the integration of fundamental medical knowledge, disease prevention, social, psychological, and economic issues. This section describes the clinical curriculum. The first part presents an outline of the Clinical Program goals and objectives. Subsequently, the full clinical curriculum is described, relating Clinical Program goals and objectives to the manner in which they are achieved. Overview of Clinical Program Goals and Objectives The Nephrology Fellowship Clinical Training Program is structured around goals and objectives derived from three major sources: ACGME Core Competencies; ACGME subspecialty requirements for Nephrology training programs additional input derived from University of Utah Nephrology faculty These various components are combined to achieve an integrated set of goals and objectives that cover all aspects of the training program. In this first section, an overview of the training program s goals and objectives is presented, broken down by the six core competencies and then the specific Nephrology areas. This should be reviewed so that Fellows understand each of these components. The following section, devoted to the detailed curriculum, then combines the core competencies and specific nephrology issues into an integrated and comprehensive set of goals and objectives. Core competencies 1. Patient care - Fellows must be able to provide patient care that is compassionate, appropriate, and effective for the treatment of health problems and the promotion of health. Fellows are expected to: a. communicate effectively and demonstrate caring and respectful behaviors when interacting with patients and their families b. gather essential and accurate information about their patients c. make informed decisions about diagnostic and therapeutic interventions based on patient information and preferences, up-to-date scientific evidence, and clinical judgment d. develop and carry out patient management plans e. counsel and educate patients and their families f. use information technology to support patient care decisions and patient education g. perform competently all medical and invasive procedures considered essential for the area of practice h. provide health care services aimed at preventing health problems or maintaining health i. work with health care professionals, including those from other disciplines, to provide patientfocused care 2. Medical knowledge - Fellows must demonstrate knowledge about established and evolving biomedical, clinical, and cognate (e.g. epidemiological and social-behavioral) sciences and the application of this knowledge to patient care. Fellows are expected to: a. demonstrate an investigatory and analytic thinking approach to clinical situations know and apply the basic and clinically supportive sciences which are appropriate to their discipline 11

12 3. Practice-based learning and improvement Fellows must be able to investigate and evaluate their patient care practices, appraise and assimilate scientific evidence, and improve their patient care practices. Fellows are expected to: a. analyze practice experience and perform practice-based improvement activities using a systematic methodology b. locate, appraise, and assimilate evidence from scientific studies related to their patients health problems c. obtain and use information about their own population of patients and the larger population from which their patients are drawn d. apply knowledge of study designs and statistical methods to the appraisal of clinical studies and other information on diagnostic and therapeutic effectiveness e. use information technology to manage information, access on-line medical information; and support their own education f. facilitate the learning of students and other health care professionals 4. Interpersonal and communication skills - Fellows must be able to demonstrate interpersonal and communication skills that result in effective information exchange and teaming with patients, their patients families, and professional associates. Fellows are expected to: a. create and sustain a therapeutic and ethically sound relationship with patients b. use effective listening skills and elicit and provide information using effective nonverbal, explanatory, questioning, and writing skills c. work effectively with others as a member or leader of a health care team or other professional group 5. Professionalism - Fellows must demonstrate a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to a diverse patient population. Fellows are expected to: a. demonstrate respect, compassion, and integrity; a responsiveness to the needs of patients and society that supercedes self-interest; accountability to patients, society, and the profession; and a commitment to excellence and on-going professional development b. demonstrate a commitment to ethical principles pertaining to provision or withholding of clinical care, confidentiality of patient information, informed consent, and business practices c. demonstrate sensitivity and responsiveness to patients culture, age, gender, and disabilities 6. Systems-based practice - Fellows must demonstrate an awareness of and responsiveness to the larger context and system of health care and the ability to effectively call on system resources to provide care that is of optimal value. Fellows are expected to: a. understand how their patient care and other professional practices affect other health care professionals, the health care organization, and the larger society and how these elements of the system affect their own practice b. know how types of medical practice and delivery systems differ from one another, including methods of controlling health care costs and allocating resources c. practice cost-effective health care and resource allocation that does not compromise quality of care d. advocate for quality patient care and assist patients in dealing with system complexities e. know how to partner with health care managers and health care providers to assess, coordinate, and improve health care and know how these activities can affect system performance Specific renal competencies - Fellows will acquire expertise in: 1. An understanding of normal renal biology including: a. Renal anatomy and histology b. Renal physiology, including in the elderly c. Fluid, electrolyte and acid-base regulation d. Mineral metabolism 12

13 e. Blood pressure regulation - normal and abnormal f. Renal drug metabolism and pharmacokinetics, including drug effects on renal function and including in the elderly g. Renal function in pregnancy h. Basic immunologic principles, including mechanisms of disease and diagnostic laboratory testing relevant to renal diseases i. Medical genetics 2. Prevention, evaluation, and management of general nephrologic disorders including: a. Acute renal failure b. Chronic renal failure c. End-stage renal disease d. Fluid, electrolyte, and acid-base disorders e. Disorders of mineral metabolism including nephrolithiasis and renal osteodystrophy (including use of lithotripsy) f. Urinary tract infections g. Hypertensive disorders h. Renal disorders related to pregnancy i. Primary and secondary glomerulopathies including infection-related glomerulopathies. This also entails a basic understanding of immunologic mechanisms of renal disease and the laboratory tests necessary for their diagnosis. j. Diabetic nephropathy k. Tubulointerstitial nephritis including papillary necrosis l. Genetic and developmental renal diseases including renal cystic diseases, hereditary glomerulopathies and interstitial nephritis, phakomatoses, systemic diseases with renal involvement, congenital malformations of the urinary tract, maternally inherited mitochondrial diseases, and renal cell carcinoma. m. Vascular diseases including atheroembolic disease n. Disorders of drug metabolism and renal drug toxicity o. Renal disorders associated with the elderly including altered drug metabolism p. Renal cystic diseases without a recognized genetic basis q. Nutritional management of general nephrologic disorders 3. Pre- and post-renal transplant care including: a. Pre-transplant selection, evaluation and preparation of transplant recipients and donors b. Immunosuppressant drug effects and toxicity c. Immediate postoperative management of transplant recipients d. Immunologic principals of types and mechanisms of renal allograft rejection e. Clinical diagnosis of all forms of rejection including laboratory, histopathologic and imaging techniques f. Prophylaxis and treatment of allograft rejection g. Recognition and medical management of nonrejection causes of allograft dysfunction including urinary tract infections, acute renal failure, and others h. Understanding major causes of post-transplant morbidity and mortality i. Fluid, electrolyte, mineral and acid-base regulation in post-transplant patients j. Long-term follow-up of transplant recipients in the ambulatory setting including economic and psychosocial issues k. Principles of organ harvesting, preservation and sharing l. Renal disease in liver, heart and bone marrow transplant recipients 4. Dialysis and extracorporeal therapy including: a. Evaluation and selection of patients for acute hemodialysis or continuous renal replacement therapies b. Evaluation of end-stage renal disease patients for various forms of therapy and their instruction regarding treatment options c. Drug dosage modification during dialysis and other extra-corporeal therapies d. valuation and management of medical complications in patients during and between dialyses and other extra-corporeal therapies, and an understanding of their pathogenesis and prevention 13

14 e. Long-term follow-up of patients undergoing chronic dialysis including their dialysis prescription modification and assessment of adequacy of dialysis f. An understanding of the principles and practice of peritoneal dialysis including the establishment of peritoneal access, the principles of dialysis catheters, and how to choose appropriate catheters. g. An understanding of the technology of peritoneal dialysis including the use of cyclers h. Assessment of peritoneal dialysis efficiency using peritoneal equilibration testing and the principles of peritoneal biopsy i. An understanding of how to write a peritoneal dialysis prescription and how to assess peritoneal dialysis adequacy j. The pharmacology of commonly used medications and their kinetic and dosage alteration with peritoneal dialysis k. An understanding of the complications of peritoneal dialysis including peritonitis and its treatment, exit site and tunnel infections and their management, hernias, plural effusions and other less common complications and their management l. An understanding of the special nutritional requirements of the hemodialysis and peritoneal dialysis patient m. An understanding of the psychosocial, economic and ethical issues of dialysis n. An understanding of dialysis water treatment, delivery systems and dialyzer reuse o. An understanding of end-of-life care and pain management in the care of patients undergoing chronic dialysis. p. Evaluation, selection and management of patients for therapeutic plasma exchange 5. Personally conducting the following procedures: a. Urinalysis b. Percutaneous biopsy of native and transplanted kidneys c. Peritoneal dialysis d. Placement of temporary vascular access for hemodialysis and related procedures including use of vascular ultrasound guidance e. Acute and chronic hemodialysis f. Continuous renal replacement therapies g. Therapeutic plasma exchange 6. Understanding indications, complications (if relevant), and interpretation of the following procedures: a. Placement of peritoneal catheters b. Renal imaging - ultrasound, CT, IVP, MRI, angiography, and nuclear medicine studies c. Therapeutic plasmapheresis d. Radiology, angioplasty and declotting of vascular access 7. Special areas in the management of patients of renal diseases including: a. Psychosocial and economic issues confronting patients with renal disease b. Ethical issues relevant to care of patients with renal disease c. Optimizing the relationship of the nephrologist with other health care providers d. Optimizing mechanisms towards achieving life-long learning as a nephrologist e. Quality assessment and improvement, patient safety, risk management, preventative medicine, and physician impairment as it relates to the nephrologist Progressive objectives The objectives of the nephrology fellowship program are designed to reflect a progressive increase in learning. The learning principles are based on Bloom's taxonomy, describing progression through the six learning domains: knowledge, comprehension, application, analysis, synthesis and evaluation. In practice, the program's objectives change every 6 months of the 2-year training period. These four 6- month periods' progressively changing objectives are summarized in the sections addressing the three major rotations - general nephrology, dialysis and transplantation. These progressive objectives are reviewed with the fellows by the Program Director at the beginning of each 6-month rotation, i.e., each time the objectives change. A detailed description of these objectives is described in the fellowship curriculum. 14

15 Nephrology Research Training Program (RETURN TO TABLE OF CONTENTS) 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. Goals and Objectives of Research Program 1. 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. 2. Gain hands-on experience with conducting a clinical research project including research design (where feasible), data analysis, subject recruitment, data collection, and manuscript preparation. 3. Understand principles of grant writing. 4. Provide sufficient exposure to clinical research to allow Fellows to make an informed decision about pursuing a career involving clinical research. 5. 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. 6. Become a co-author on a published manuscript or abstract, or present research at a national meeting. Educational Training 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. 3. The research mentor-fellow relationship is the primary means by which Fellows will achieve training in clinical research. 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 months during other rotations) between the Fellow and mentor during which all aspects of conducting the clinical research projects are addressed. 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 15

16 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. 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. Goals and Objectives of Research Program 1. 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. 2. 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. 3. Understand principles of grant writing. 4. Provide sufficient experience in basic or clinical research to allow Fellows to make an informed decision about their academic career choices. 5. Provide sufficient exposure to basic or clinical research to allow Fellows to interpret basic and clinical research literature. Educational Training 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. 2. 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. 3. 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 16

17 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 weekly one-hour course entitled "Scientific Integrity & Ethics of Scientific Research". This course meets federal requirements for training grants and is described below. 4. 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. 5. 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 BLOCK (6 weeks) MDCRC 6010 Introduction to Epidemiology. Covers the basics of epidemiology including: measures of disease frequency, measures of effect, basic study designs, confounding bias, stratification, and causal reasoning. This course is presented in two-hour 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 twohour 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 17

18 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. 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. FALL SEMESTER YEAR ONE SPRING SEMESTER YEAR ONE 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. Case- based 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 twohour 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 18

19 FALL SEMESTER YEAR TWO 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 data (generalized estimating equations and mixed models), testing model assumptions, and assessment of model fit. This course is presented in a weekly twohour 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, multistage 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. 1. 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. 2. 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. 3. 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. 4. 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. 19

20 Schedule B. Basic research core courses. FALL SEMESTER YEAR ONE FALL AND SPRING SEMESTER YEAR ONE FALL SEMESTER YEAR TWO BLCHM 6400 Genetic Engineering. This course covers essential techniques used in genetic engineering. Topics include the use of restriction endonucelases, amplification of 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. PHYS 7910 Practicum in Physiology. A laboratory-oriented practicum emphasizing 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 Molecular Biology PHYS 6010 Systemic Physiology II. Must have had basic physiology. Emphasizes physiological principles of major organ systems. Three hours weekly in fall semester. 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. 20