1. HARVARD MEDICAL SCHOOL
Department of Continuing Education
PRIMARY CARE
INTERNAL MEDICINE
Principles and Practice
2008
Course Director Associate Directors
John D. Goodson, M.D. Charles J. Hatem, M.D.
Massachusetts General Hospital Mount Auburn Hospital
Albert G. Mulley, M.D.
Massachusetts General Hospital
Richard J. Pels, M.D.
Cambridge Hospital
William C. Taylor, M.D.
Beth Israel Deaconess Medical Center
Program Coordinator
Linda C. Lufkin
http://www.pcim.edu
2.
3. Primary Care Internal Medicine: Principles and Practice
October 20- 24, 2008
Table of Contents: General Session
General Information ....................................................................................................... I
Schedule ......................................................................................................................... V
Faculty............................................................................................................................. XV
Statement of Conflict of Interest................................................................................... XXVI
Medical headlines 2008: Evaluating recent “evidence” for clinical practice
John D. Goodson, M.D. ........................................................................................ 1
Advanced treatment choices for ischemic heart disease
Eric M. Isselbacher, M.D. ..................................................................................... 25
Anticoagulation in practice
David J. Kuter, M.D. ............................................................................................. 39
Peripheral vascular disease
Michael R. Jaff, D.O.. ........................................................................................... 109
Sleep disorders
John Winkelman, M.D. ......................................................................................... 145
Approaches to depression
Roy H. Perlis, M.D.. .......................................................................................... 157
Clinical updates in infectious disease:
Frequently asked questions
Nesli Basgoz, M.D. ............................................................................................... 171
Reflux, dyspepsia and disorders of the foregut
Ciarán P. Kelly, M.D. ............................................................................................ 171
Obesity management: Medical and surgical options
Lee M. Kaplan, M.D.............................................................................................. 181
Radiology update: How to effectively
employ current imaging technologies
Kitt Shaffer, M.D. .................................................................................................. 205
Diabetes: Old and new treatment strategies
and case discussion
David M. Nathan, M.D. ......................................................................................... 229
Understanding the art of apology in healing
Aaron Lazare, M.D. .............................................................................................. 251
Update in clinical hematology, 2008
Lisa Weissmann, M.D. ......................................................................................... 261
4. Therapeutic options for delirium
Theodore A. Stern, M.D. ...................................................................................... 269
Neurological Exam
Martin A. Samuels, M.D. ...................................................................................... 279
Renewal in the practice of medicine
Charles J. Hatem, M.D. ........................................................................................ 285
Chronic lung disease
Walter J. O’Donnell, M.D. ..................................................................................... 307
Practice innovation: Improving office workflow
Christine A. Sinsky, M.D....................................................................................... 325
Active management of renal insufficiency
David J. R. Steele, M.D. ....................................................................................... 343
Lipid management: Mono and combination therapy
G. Sherry Haydock, M.D. ..................................................................................... 357
Osteoporosis update 2008
John D. Goodson, M.D. ........................................................................................ 373
Early detection of prostate cancer
Michael J. Barry, M.D. .......................................................................................... 443
Asthma: A guide for achieving good control
Christopher H. Fanta, M.D. .................................................................................. 453
The patient centered medical home:
Functional characteristics, possible
Benefits and reimbursement options
Christine A. Sinksy, M.D., Thomas A. Sinsky, M.D.
John D. Goodson, M.D., Susan Edgman-Levitan, PA .......................................... 467
Disease on the colon: IBS and IBD
Joshua Korzenik, M.D. ......................................................................................... 475
Managing menopause amid controversy
Carol K. Bates, M.D.............................................................................................. 487
Colon cancer: Screening, evaluation and management
David P. Ryan, M.D. ............................................................................................. 511
Lessons learned: The limits of evidence
in caring for individual patients
Albert G. Mulley, M.D. .................................................................................. 523
5. Primary Care Internal Medicine: Principles and Practice
General Information
On behalf of the faculty, I would like to welcome each of you personally and individually
to our course. We look forward to an exciting and rewarding week together.
For any problems during the week, please contact either me or Linda Lufkin, Program
Coordinator, at the Registration Desk outside the Ballroom.
1. Syllabus: We have asked all of our speakers to provide you with a carefully annotated
outline, which both closely follows their planned presentation and provides all the
important information contained on slides.
2. Workshops: Workshop assignments have been provided for you at registration. Since
space is limited, we would ask that you abide by your assignments. If you wish to
make a change, please talk to Linda Lufkin at the registration desk. All workshop
material has been provided in the syllabus so that if you are unable to attend a specific
session, the material discussed is available. The location for the workshops is provided
on the map, which you received at registration and is also included in the main syllabus.
Those who registered after the workshop registration deadline should plan to sign
up for workshops after the first morning session today. Workshop material in the
syllabus has been alphabetized by the last name of the workshop leader.
3. Question Policy: We will take questions at the conclusion of each presentation. In
addition, speakers will be available for questions at the rear of the auditorium at the
conclusion of their presentation. We have provided the address and phone numbers of
all speakers should you wish to make contact on an individual basis.
4. Breaks: We will ring a bell five minutes before the end of each break and ask that
you begin returning to the conference area at that time so that we can maintain our
schedule.
5. Security: Please label all material and remove your course material from the main
Ballroom in the afternoon since there may be other functions in this room during a
given night.
6. Room Temperature: We plan to start each day with the room somewhat cool. Please
bring a coat or a sweater to the morning session if it seems too chilly. The room will
warm up as the day progresses. Please talk to Linda Lufkin or John Goodson if the room
temperature is uncomfortable.
7. Breakfast Session: A continental buffet breakfast will be served Tuesday - Friday
outside the Grand Ballroom foyer between 7:00 and 8:00 a.m. All participants are
welcome. This is an opportunity to meet informally with other participants and faculty.
8. Reception: Please join us for a 6:30 p.m. Reception Grand Ballroom foyer at the
conclusion of Tuesday’s program.
9. Thursday Evening Session: 7:30 – 9:30, “The patient centered medical home:
Functional characteristics, possible benefits and reimbursement options.” There will be
ample time for interaction discussion.
III
6. 10. Evaluation Forms: This information is an essential component of our program planning
and we not only read and review every questionnaire returned, but will also provide
any specific comments that you make about a given speaker to that individual
directly.
11. Messages: There will be a message board located at the Registration Area outside the
Ballroom. Our telephone number during the week for outside calls will be 617-806-5133.
12. Cell Phones and Pagers: Please put your cell phone on the silence mode (vibrate)
and take all phone calls outside the ballroom session area.
13. CME Credits: A Physician Participation Verification Form was supplied to you in
your registration packet. The AMA requires that the number of credits listed on CME
certificates be based on the actual credit claimed by each physician. You may hand this
form in at the end of the course or return it to us via fax (617) 384-8686 or mail to
Harvard Medical School, Department of Continuing Education, 21 Landmark Center, 2nd
Floor West, 401 Park Drive, Boston, MA 02215. If you attended the entire course and
return this form to us at the end of the course, you will receive your CME certificate at
that time.
Otherwise, it will be mailed to you about 45 days after we receive the form. The form
must be returned within 30 days after the end of the course. This form may not be made
out in advance of any session for which you are claiming credit
The American Academy of Family Physicians has reviewed and approved this
program for 38.00 prescribed credits.
4 to 8 hours of this program, depending on workshop selections, are designed to meet
the criteria for Risk Management credit in Massachusetts. A list of those sessions that
meet this requirement was included in your registration packet.
14. Extra Syllabi: These will be available at the Registration Desk for $100.00. Please
contact Linda Lufkin, Program Coordinator, at the Registration Desk outside the
Ballroom.
15. Checkout: Express checkout is available. Anyone may leave luggage with the Bell
Captain in the Lobby on Friday morning.
16. Concierge Service: The concierge is happy to provide any miscellaneous services you
may wish during the week including reservations, directions, maps, and lost and found.
17. Book Sales: Representatives from Lippincott Williams & Wilkins and Elsevier Sciences
will be available between sessions throughout the week for book purchases.
18. Lunches: There are two restaurants in the hotel, ArtBar and Dante. There are also a
number of restaurants located across the street at the CambridgeSide Galleria Mall.
Lower level of the mall has a Food Court.
IV
7. Primary Care Internal Medicine: Principles and Practice
Monday, October 20, 2008
General Session
7:00 Registration
7:45 Introduction John D. Goodson, M.D.
8:00 Medical headlines 2008: Evaluating recent
“evidence” for clinical practice * John D. Goodson, M.D.
9:00 Advanced treatment choices for
ischemic heart disease Eric M. Isselbacher, M.D.
10:00 Coffee break
10:20 Anticoagulation in practice David J. Kuter, M.D.
11:20 Peripheral vascular disease Michael R. Jaff, D.O.
12:20 Session ends, lunch break
1:30 Sleep disorders John Winkelman, M.D.
2:15 Approaches to depression Roy H. Perlis, M.D.
3:00 Break
3:20-4:30 Workshop Sessions A
4:30 Break
4:45 – 6:00 Workshop Sessions B
* Meet criteria for Risk Management credit in Massachusetts
V
8. Primary Care Internal Medicine: Principles and Practice
Monday, October 20, 2008
3:20 – 4:30 pm
Workshop Sessions A
A1 Thyroid disease (repeated) William M. Kettyle, M.D.
A2 Otolaryngology in primary care (repeated) R. William Mason, M.D.
A3 Dermatology (repeated) Bonnie T. Mackool, M.D.
A4 Supraventricular arrhythmias Jeremy N. Ruskin, M.D.
A5 Update in women’s reproductive health Randy Wertheimer, M.D.
A6 Case studies in geriatric care Anne R. Fabiny, M.D.
A7 Building efficient evidence-based
clinical decision support using paper,
computer and hand-held electronic resources * James J. Heffernan, M.D.
A8 Stroke prevention and management Lee H. Schwamm, M.D.
4:45 – 6:00 pm
Workshop Sessions B
B1 Thyroid disease (repeated) William M. Kettyle, M.D.
B2 Otolaryngology in primary care (repeated) R. William Mason, M.D.
B3 Rheumatology (repeated) Peter A. Merkel, M.D.
B4 Preoperative medical evaluation (repeated) Daniel P. Hunt, M.D.
B5 Therapeutic approaches to the knee (repeated) Bertram Zarins, M.D.
B6 Movement disorders Jang-Ho J. Cha, M.D.
B7 Skin ulcer management with demonstration Virginia A. Capasso, PhD.
B8 Men’s health Frederic M. Goldman, M.D.
* Meet criteria for Risk Management credit in Massachusetts
VI
9. Primary Care Internal Medicine: Principles and Practice
Tuesday, October 21, 2008
General Session
7:00 Buffet breakfast with the faculty
8:00 Clinical updates in infectious disease:
Frequently asked questions Nesli Basgoz, M.D.
9:00 Reflux, dyspepsia and disorders of the
foregut Ciarán P. Kelly, M.D.
10:00 Coffee break
10:20 Obesity management: Medical
and surgical options Lee M. Kaplan, M.D.
11:20 Radiology update: How to effectively employ
current imaging technologies Kitt Shaffer, M.D.
12:20 Session ends, lunch break
1:30 Diabetes: Old and new treatment
strategies and case discussion David M. Nathan, M.D.
3:00 Break
3:20-4:30 Workshop Sessions C
4:30 Break
4:45 – 6:00 Workshop Sessions D
6:30 Reception
* Meet criteria for Risk Management credit in Massachusetts
VII
10. Primary Care Internal Medicine: Principles and Practice
Tuesday, October 21, 2008
3:20 – 4:30 pm
Workshop Sessions C
C1 Dermatology (repeated) Bonnie T. Mackool, M.D.
C2 Dementia (repeated) Alireza Atri, M.D.
C3 New models for addiction management Michael F. Bierer, M.D.
C4 Vulvar disorders and female
urinary incontinence Julie Jolin, M.D.
May M. Wakamatsu, M.D.
C5 Menopause Jan L. Shifren, M.D.
C6 Occupational and environmental health Rose H. Goldman, M.D.
C7 Prostatitis and male pelvic pain syndromes Mary McNaughton-Collins, M.D.
C8 Medical care of the pregnant women for
the primary care provider Lucia Larson, M.D.
Margaret A. Miller, M.D.
4:45 – 6:00 pm
Workshop Sessions D
D1 Fluid and electrolyte abnormalities Eliot C. Heher, M.D.
D2 Dementia (repeated) Alireza Atri, M.D.
D3 Therapeutic approaches to the knee (repeated) Samuel H. Doppelt, M.D.
D4 Rheumatology (repeated) Sukran Ergin, M.D.
D5 Headaches David W. Chen, M.D.
D6 Case studies in office endocrinology J. Carl Pallais, M.D.
D7 Chronic pain management for non-cancer patients Richard J. Pels, M.D.
D8 Adolescent medicine Traci L. Brooks, M.D.
* Meet criteria for Risk Management credit in Massachusetts
VIII
11. Primary Care Internal Medicine: Principles and Practice
Wednesday, October 22, 2008
General Session
7:00 Buffet breakfast with the faculty
8:00 Understanding the art of apology in healing * Aaron Lazare, M.D.
9:00 Update in clinical hematology, 2008 Lisa Weissmann, M.D.
10:00 Coffee break
10:20 Therapeutic options for delirium Theodore A. Stern, M.D.
11:20 Neurologic exam Martin A. Samuels, M.D.
12:20 Session ends, lunch break
1:30 Renewal in the practice of medicine Charles J. Hatem, M.D.
2:30 Chronic lung disease Walter J. O’Donnell, M.D.
3:30 Break
3:45-5:15 Workshop Sessions E
* Meet criteria for Risk Management credit in Massachusetts
IX
12. Primary Care Internal Medicine: Principles and Practice
Wednesday, October 22, 2008
3:45 – 5:15 pm
Workshop Sessions E
E1 Case studies in diabetes management Vera T. Fajtova, M.D.
E2 Shoulder/neck pain (repeated) Jeffrey L. Zilberfarb, M.D.
E3 Ophthalmology in primary care (repeated) Claudia Richter, M.D.
E4 Preoperative medical evaluation (repeated) Daniel P. Hunt, M.D.
E5 Interpersonal challenges in the
doctor-patient relationship * Elizabeth Gaufberg, M.D.
E6 Allergy and urticaria James A. MacLean, M.D.
E7 Foot and ankle problems George H. Theodore, M.D.
E8 Successful strategies for teaching and
learning for clinical educators Charles J. Hatem, M.D.
* Meet criteria for Risk Management credit in Massachusetts
X
13. Primary Care Internal Medicine: Principles and Practice
Thursday, October 23, 2008
General Session
7:00 Buffet breakfast with the faculty
8:00 Practice innovation: Improving office
workflow * Christine A. Sinsky, M.D.
Thomas A. Sinsky, M.D.
9:00 Active management of renal
insufficiency David J. R. Steele, M.D.
10:00 Coffee break
10:20 Lipid management: Mono and
combination therapy G. Sherry Haydock, M.D.
11:20 Osteoporosis update 2008 John D. Goodson, M.D.
12:20 Session ends, lunch break
1:30 Early detection of prostate cancer Michael J. Barry, M.D.
2:30 Asthma: A guide for achieving good control Christopher H. Fanta M.D.
3:30 Break
3:45-5:15 Workshop Sessions F
7:30 – 9:30 pm
Evening Session
The patient centered medical home: Functional characteristics,
possible benefits and reimbursement options Christine A. Sinsky, M.D.
Thomas A. Sinsky, M.D.
John D. Goodson, M.D.
Susan Edgman-Levitan, PA
* Meet criteria for Risk Management credit in Massachusetts
XI
14. Primary Care Internal Medicine: Principles and Practice
Thursday, October 23, 2008
3:45 – 5:15 pm
Workshop Sessions F
F1 Ophthalmology in primary care (repeated) Laura C. Fine, M.D.
F2 Shoulder/neck pain (repeated) Thomas J. Gill, M.D.
F3 Effective strategies for behavior change * William C. Taylor, M.D.
F4 Congestive heart failure Christopher Newton-Cheh, M.D.
F5 Hypertension Gerald W. Smetana, M.D.
F6 Travel medicine Edward T. Ryan, M.D.
F7 Case studies in practice innovation * Christine A. Sinsky, M.D.
Thomas A. Sinsky, M.D.
F8 Physical medicine: Case studies in the Joanne Borg-Stein, M.D.
management of spine disease
* Meet criteria for Risk Management credit in Massachusetts
XII
15. Primary Care Internal Medicine: Principles and Practice
Friday, October 24, 2008
General Session
7:00 Buffet breakfast with the faculty
8:00 Diseases of the colon: IBS and IBD Joshua Korzenik, M.D.
9:00 Managing menopause amid controversy Carol Bates, M.D.
10:00 Coffee break
10:20 Colon cancer: Screening, evaluation
and management David P. Ryan, M.D.
11:20 Lessons learned: The limits of evidence
in caring for individual patients * Albert G. Mulley, M.D.
12:20 Course concludes
* Meet criteria for Risk Management credit in Massachusetts
XIII
16.
17. ALIREZA ATRI, M.D. Ph.D., Clinical Instructor in Neurology, Harvard Medical School;
Assistant in Neurology, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-1728
Neurology Memory Disorders Unit Email: aatri@partners.org
15 Parkman Street, WAC 830
Boston, MA 02114
MICHAEL J. BARRY, M.D., Professor of Medicine, Harvard Medical School; Chief,
General Medicine Unit, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-4106
Medical Practices Evaluation Center Email: mbarry@partners.org
50 Staniford Street, 9th Floor
Boston, MA 02114
NESLI BASGOZ, M.D., Associate Professor of Medicine, Harvard Medical School; Associate Chief
and Clinical Director, Infectious Disease Division, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-3906
100 Blossom Street, Cox 5 Email: nbasgoz@partners.org
Boston, MA 02114
CAROL K. BATES, M.D., Associate Professor of Medicine, Harvard Medical School;
Primary Care Program Director, Beth Israel Deaconess Medical Center.
Healthcare Associates Tel: 617-667-4877
Beth Israel Deaconess Medical Center Email: cbates@bidmc.harvard.edu
330 Brookline Avenue, E/CC-6
Boston, MA 02215
MICHAEL F. BIERER, M.D., M.P.H., Assistant Professor of Medicine, Harvard Medical School;
Associate Physician, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-6200
15 Parkman Street, WAC 615 Email: mbierer@partners.org
Boston, MA 02114
JOANNE BORG-STEIN, M.D., Assistant Professor of Physical Medicine and
Rehabilitation, Harvard Medical School; Medical Director, Spaulding-Wellesley
Rehab Center.
Spaulding Rehabilitation Hospital Tel: 781-431-9144
65 Walnut Street
Wellesley, MA 02481
XV
18. TRACY L. BROOKS, M.D., Instructor in Pediatrics, Harvard Medical School; Director of
Adolescent Medical Services, Cambridge Health Alliance.
Cambridge Hospital Tel: 617-665-1264
1493 Cambridge Street Email: traci_brooks@hms.harvard.edu
Cambridge, AM 02139
VIRGINIA A. CAPASSO, Ph.D., APRN, Instructor in Surgery, HMS; Co-Director, MGH
Wound Care Center CNS, Knight Center for Clinical and Professional Development,
Nurse Scientist, Munn Center for Nursing Research, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-3836
55 Fruit Street, FND 3 Email: vcapasso@partners.org
Boston, MA 02114
JANG-HO J. CHA, M.D., Ph.D., Associate Professor of Neurology, Harvard Medical
School; Associate Professor, Massachusetts General Hospital.
MassGeneral Institute for Tel: 617-724-1481
Neurodegenerative Disease Email: cha@helix.mgh.harvard.edu
114 16th Street, B 114-2000
Charlestown, MA 02129
DAVID W. CHEN, M.D., Instructor in Neurology, Harvard Medical School; Assistant in Neurology,
Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-8602
15 Parkman Street, WAC 835 Email: dwchen@partners.org
Boston, MA 02114
SAMUEL H. DOPPELT, M.D., Assistant Clinical Professor of Orthopedic Surgery,
Harvard Medical School; Chief Orthopedic Surgery, Cambridge Hospital.
Cambridge Hospital Tel: 617-665-1566
Department of Orthopedic Surgery Email: sdoppelt@challiance.org
1493 Cambridge Street
Cambridge, MA 02139
SUSAN EDGMAN-LEVITAN, PA, Executive Director, The John D. Stoeckle Center for
Primary Care Innovation, Massachusetts General Hospital.
The John D. Stoeckle Center Tel: 617-724-8824
for Primary Care Innovation
Massachusetts General Hospital
50 Staniford Street, 9th Floor
Boston, MA 02114
XVI
19. SUKRAN ERGIN, M.D., Instructor in Medicine, Harvard Medical School; Staff Physician,
Division of Rheumatology, Beth Israel Deaconess Medical Center.
Beth Israel Deaconess Medical Center Tel: 617632-8658
110 Francis Street, Suite 4B Email : sergin@bidmc.harvard.edu
Boston, MA 02215
ANNE R. FABINY, M.D., Assistant Professor of Medicine, Harvard Medical School; Chief
of Geriatrics, Cambridge Health Alliance.
Cambridge Hospital Tel: 617-665-1029
1493 Cambridge Street, Macht Bldg Email: afabiny@challiance.org
Cambridge, MA 02139
VERA T. FAJTOVA, M.D., Assistant Professor in Medicine, Harvard Medical School;
Department of Endocrinology, Harvard Vanguard Medical Associates/Brigham and
Women’s Hospital.
Harvard Vanguard Medical Associates Tel: 617-421-1380
133 Brookline Avenue Email: vfajtova@partners.org
Boston, MA 02215
CHRISTOPHER H. FANTA, M.D., Associate Professor of Medicine, Harvard Medical
School; Member, Pulmonary and Critical Care Medicine, Brigham and Women's
Hospital, Director, Partners Asthma Center.
Brigham and Women's Hospital Tel: 617-732-4353
Pulmonary and Critical Care Medicine Email: cfanta@partners.org
75 Francis Street
Boston, MA 02115
LAURA C. FINE, M.D., Clinical Instructor in Ophthalmology, Harvard Medical School;
Ophthalmologist, Ophthalmic Consultants of Boston, Active Staff, Massachusetts
Eye & Ear Infirmary.
Ophthalmic Consultants of Boston Tel: 617-314-2794
50 Staniford Street, Suite 600 Email: lcfine@eyeboston.com
Boston, MA 02114
ELIZABETH GAUFBERG, M.D., MPH, Assistant Professor of Medicine and Psychiatry,
Harvard Medical School; Director of Professional Development, Department of
Medicine, The Cambridge Health Alliance.
Cambridge Hospital Tel: 617-665-1343
1493 Cambridge Street
Cambridge, MA 02139
XVII
20. THOMAS J. GILL, M.D., Associate Professor of Orthopedic Surgery, Harvard Medical
School; Chief, Sports Medicine, Department of Orthopaedic Surgery,
Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-7797
175 Cambridge Street, Suite 400 Email: tgill@partners.org
Boston, MA 02114
FREDERIC M. GOLDMAN, M.D., Instructor in Medicine, Harvard Medical School;
North Suite Director, Healthcare Associates, Beth Israel Deaconess Medical Center.
Beth Israel Deaconess Medical Center Tel: 617-667-9600
330 Brookline Avenue – Shapiro 6 Email: fgoldman@caregroup.harvard.edu
Boston, MA 02215
ROSE H. GOLDMAN, M.D., M.P.H., Associate Professor of Medicine, Harvard Medical School; Chief,
Occupational and Environmental Health, The Cambridge Health Alliance; Associate Professor
Environmental Health Sciences, Department of Environmental Health, Harvard School of Public
Health.
Cambridge Hospital Tel: 617-665-1580
1493 Cambridge Street Email: rgoldman@challiance.org
Macht Center, Room 427
Cambridge, MA 02139
JOHN D. GOODSON, M.D., Associate Professor of Medicine, Harvard Medical School;
Physician, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-3450
Internal Medicine Associates Email: jgoodson1@partners.org
15 Parkman Street, WAC 625
Boston, MA 02114
CHARLES J. HATEM, M.D., Harold Amos Academy Professor of Medicine, Harvard Medical School;
Director of Medical Education, Mount Auburn Hospital; Co-Director of Medical Education
Fellowships at The Carl J. Shapiro Institute for Education and Research, Mt. Auburn Hospital
and the Academy at Harvard Medical School. Director, Academy Center for Teaching and
Learning, Harvard Medical School.
Mount Auburn Hospital Tel: 617-499-5140
Department of Medicine Email: chatem@caregroup.harvard.edu
330 Mount Auburn Street
Cambridge, MA 02238
G. SHERRY HAYDOCK, M.D., Assistant Professor of Medicine, Harvard Medical School; Physician,
Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-2368
Internal Medicine Associates Email: ghaydock@partners.org
15 Parkman Street, WAC 645
Boston, MA 02114
XVIII
21. JAMES J. HEFFERNAN, M.D., M.P.H., Associate Professor of Medicine, Harvard Medical
School; Director of Healthcare Associates, Beth Israel Deaconess Medical Center.
Beth Israel Deaconess Medical Center Tel: 617-667-9699
330 Brookline Avenue Email: jheffern@bidmc.harvard.edu
Boston, MA 02215
ELIOT C. HEHER, M.D., Instructor in Medicine, Harvard Medical School; Assistant in
Medicine, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-2000
Nephrology Division, GRB 1003 Email: eheher@partners.org
55 Fruit Street, GRB 1003
Boston, MA 02114
DANIEL P. HUNT, M.D., Associate Professor of Medicine, Harvard Medical School;
Director, Inpatient Clinician Educator Service, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-573-2382
Inpatient Clinician Educator Service Email: dphunt@partners.org
50 Staniford Street, Suite 503b
Boston, MA 02114
ERIC M. ISSELBACHER, M.D., Associate Professor of Medicine, Harvard Medical School;
Assistant Physician, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-1994
32 Fruit Street, YAW 5B-5980 Email: eisselbacher@partners.org
Boston, MA 02114
MICHAEL R. JAFF, D.O., Associate Professor of Medicine, Harvard Medical School;
Medical Director, Vascular Center, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-3784
55 Fruit Street, Gray-Bigelow 832 Email: mjaff@partners.org
Boston, MA 02114
JULIE JOLIN, M.D., Instructor in Obstetrics, Gynecology and Reproductive Biology,
Harvard Medical School; Assistant in Gynecology and Obstetrics, Massachusetts
General Hospital.
Massachusetts General Hospital Tel: 617-724-3360
55 Fruit Street, Founder 4
Boston, MA 02114
XIX
22. LEE M. KAPLAN, M.D., Ph.D., Associate Professor of Medicine, Harvard Medical School;
Director, MGH Weight Center, Massachusetts General Hospital.
MGH Weight Center Tel: 617-726-3768
50 Staniford Street, 4th Floor Email: lmkaplan@partners.org
Boston, MA 02114
CIARAN P. KELLY, M.D., Associate Professor at Harvard Medical School; Firm Chief, Herman
L. Blumgart Internal Medicine, Director of Gastroenterology Fellowship Training
Program, Beth Israel Deaconess Medical Center.
Beth Israel Deaconess Medical Center Tel: 617-667-1272
330 Brookline Avenue, DA-601 Email: ckelly2@bidmc.harvard.edu
Boston, MA 02215
WILLIAM M. KETTYLE, M.D., Assistant Clinical Professor of Medicine, Harvard Medical
School; Medical Director, Massachusetts Institute of Technology Medical Department.
Massachusetts Institute of Technology Tel: 617-253-1716
Medical Department, E23-279 Email: kett@med.mit.edu
77 Massachusetts Avenue
Cambridge, MA 02139
JOSHUA KORZENIK, M.D., Assistant Professor of Medicine, Harvard Medical School;
Physician, Gastrointestinal Unit, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-0267
165 Cambridge Street, 9th Floor
Boston, MA 02114
DAVID J. KUTER, M.D., Associate Professor of Medicine, Harvard Medical School;
Chief of Hematology, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-8743
Hematology Email: dkuter@partners.org
55 Fruit Street, YAW 7940
Boston, MA 02114
LUCIA LARSON, M.D., Associate Professor of Medicine and Obstetrics and Gynecology,
The Warren Alpert Medical School of Brown University; Director, Fellowship in
Obstetric and Consultative Medicine, Women and Infants Hospital of Rhode Island.
Women and Infants Hospital of Tel: 401-453-7950
Rhode Island Email: llarson@wihri.org
Department of Medicine, Suite 1440
101 Dudley Street
Providence, RI 02905
XX
23. AARON LAZARE, M.D., Professor of Psychiatry, Harvard Medical School; Celia and Issac Haidak
Distinguished Professor of Medical Education, Chancellor and Dean Emeritus, University of
Massachusetts Medical School.
University of Massachusetts Tel: 508-856-3260
Medical School Email: aaron.lazare@umassmed.edu
Office of the Chancellor
55 Lake Avenue North
Worcester, MA 01655
BONNIE T. MACKOOL, M.D., MSPH, Assistant Professor of Dermatology, Harvard Medical School;
Director Consultation Service, Department of Dermatology, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-2765
55 Fruit Street, Bartlett 618 Email: bmackool@partners.org
Boston, MA 02114
JAMES A. MacLEAN, M.D., Clinical Assistant Professor of Medicine, Harvard Medical School;
Associate Physician, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-3260
100 Blossom Street, Cox 201 Email: jmaclean@partners.org
Boston, MA 02114
R. WILLIAM MASON, M.D., Associate Professor of Surgery, Boston University School
of Medicine; Surgeon, Department of Surgery, Brigham and Women’s Hospital/Faulkner
Hospital.
Faulkner Hospital Tel: 617-524-3864
1153 Center Street, Suit 52
Boston, MA 02130
MARY F. McNAUGHTON COLLINS, M.D., M.P.H., Associate Professor of Medicine,
Harvard Medical School; Associate Physician, Internal Medicine Associates,
Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-3205
50 Staniford Street, 9th Floor Email: mmcnaughtoncollins@partners.org
Boston, MA 02114
PETER A. MERKEL, M.D., M.P.H., Associate Professor of Medicine, Section of Rheumatology and
the Clinical Epidemiology Unit, Director Vasculitis Center, Boston University School of Medicine.
Boston University School of Medicine Tel: 617-414-2501
Arthritis Center, E-5 Email: pmerkel@bu.edu
715 Albany Street
Boston, MA 02118-2393
XXI
24. MARGARET A. MILLER, M.D., Assistant Professor of Obstetrics and Gynecology, Brown
Medical School; Director of Ambulatory Services Division, Department of Medicine,
Women and Infants Hospital.
Women and Infants Hospital Tel: 401-453-7950
of Rhode Island
101 Dudley Street
Providence, RI 02905
ALBERT G. MULLEY, M.D., Associate Professor of Medicine and Associate Professor of Health Policy,
Harvard Medical School; Chief, General Medicine Division, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-4121
Chief, General Medicine Division Email: lmulley@partners.org
50 Staniford Street, 9th Floor
Boston, MA 02114
DAVID M. NATHAN, M.D., Professor of Medicine, Harvard Medical School; Physician,
Massachusetts General Hospital; Director of Diabetes Center, Director of General
Clinical Research Center, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-2875
Diabetes Unit Email: dnathan@partners.org
32 Fruit Street, Bulfinch 4
Boston, MA 02114
CHRISTOPHER NEWTON-CHEH, M.D., Instructor in Medicine, Harvard Medical School;
Assistant in Medicine, Cardiology Division, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-6158
Heart Failure & Transplant Section
32 Fruit Street, GRB 847
Boston, MA 02114
WALTER J. O’DONNELL, M.D., Associate Professor of Medicine, Harvard Medical School Assistant
Chief of Medicine for Clinical Operations and Quality, Clinical Director, Pulmonary and Critical
Care Unit
Massachusetts General Hospital Tel: 617-726-9112
Pulmonary and Critical Care Unit Email: wtodonnell@partners.org
55 Fruit Street, Cox-2
Boston, MA 02114
J. CARL PALLAIS, M.D., Instructor in Medicine, Harvard Medical School; Assistant in Medicine,
Endocrine Unit, Director, Endocrine Elective for the Internal Medicine Residency Program,
Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-643-0593
50 Staniford Street, 7th Floor Email: jpallais@partners.org
Boston, MA 02114
XXII
25. RICHARD J. PELS, M.D., Assistant Professor of Medicine, Harvard Medical School; Associate Chief of
Medicine, Director, Graduate Medical Education, and Residency Program, Director, Internal
Medicine, The Cambridge Health Alliance.
Cambridge Hospital Tel: 617-665-1016
1493 Cambridge Street
Cambridge, MA 02139
ROY H. PERLIS, M.D., Assistant Professor of Psychiatry, Harvard Medical School; Medical Director,
Bipolar Clinical and Research Program and Center for Human Genetic Research, Assistant
Psychiatrist, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-7426
185 Cambridge Street – CPZN-6 Email: rperlis@partners.org
Boston, MA 02114
CLAUDIA U. RICHTER, M.D., Clinical Assistant in Ophthalmology, Harvard Medical
School; Surgeon, Massachusetts Eye and Ear Infirmary.
Ophthalmic Consultants of Boston Tel: 617-367-4800
50 Staniford Street Email: curichter@eyeboston.com
Boston, MA 02114
JEREMY N. RUSKIN, M.D., Associate Professor of Medicine, Harvard Medical School;
Physician and Director, Cardiac Arrhythmias Service, Massachusetts General
Hospital.
Massachusetts General Hospital Tel: 617-726-8514
55 Fruit Street, GRB-109
Boston, MA 02114
DAVID P. RYAN, M.D., Assistant Professor of Medicine, Harvard Medical School; Assistant
Physician, Hematology/Oncology Department, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-0245
32 Fruit Street, YAW 7E
Boston, MA 02114
EDWARD T. RYAN, M.D., Associate Professor in Medicine, Harvard Medical School &
Harvard School of Public Health; Physician, Assistant Pediatrician, Director,
Travelers’ Advice and Immunization Center, Director, Tropical and Geographic
Medicine, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-6175
Division of Infectious Disease Email: etryan@partners.org
100 Blossom Street, Cox 5
Boston, MA 02114
XXIII
26. MARTIN A. SAMUELS, M.D., Professor of Neurology, Harvard Medical School;
Neurologist-in-Chief, Brigham and Women's Hospital.
Neurologist-in-Chief Tel: 617-732-5355
Brigham and Women's Hospital Email: msamuels@partners.org
75 Francis Street
Boston, MA 02115
LEE H. SCHWAMM, M.D., Associate Professor of Neurology, Harvard Medical School;
Vice Chairman, Department of Neurology, Director TeleStroke & Acute Stroke Services,
Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-1597
Department of Neurology Email: lschwamm@partners.org
55 Fruit Street, WAC-720
Boston, MA 02114
KITT SHAFFER, M.D., PhD., Associate Professor of Radiology, Harvard Medical School;
Director of Radiology Education, Cambridge Health Alliance.
Cambridge Health Alliance Tel: 617-665-3163
10 Beacon Street Email: kshaffer@challiance.org
Somerville, MA 02139
JAN L. SHIFREN, M.D., Associate Professor of Obstetrics, Gynecology and Reproductive
Biology, Harvard Medical School; Director, Menopause Program, Vincent Obstetrics
and Gynecology Service, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-8868
55 Fruit Street, YAW 10A
Boston, MA 02114
CHRISTINE A. SINSKY, M.D., Department of Internal Medicine, Medical Associates Clinic
and Health Plans, Dubuque, IA.
Medical Associates Clinic Tel: 563-584-3195
and Health Plans Email: csinsky1@mahealthcare.com
1000 Langworthy Drive
Dubuque, IA 52001
THOMAS A. SINSKY, M.D., Department of Internal Medicine, Medical Associates Clinic
and Health Plans, Dubuque, IA.
Medical Associates Clinic Tel: 563-584-3195
and Health Plans Email: tsinsky1@mahealthcare.com
1000 Langworthy Drive
Dubuque, IA 52001
XXIV
27. GERALD W. SMETANA, M.D., Associate Professor of Medicine, Harvard Medical
School; Physician, Division of General Medicine and Primary Care, Beth Israel
Deaconess Medical Center.
Beth Israel Deaconess Medical Center Tel: 617-667-9699
Division of General Medicine Email: gsmetana@bidmc.harvard.edu
330 Brookline Avenue
Boston, MA 02215
DAVID J. R. STEELE, M.D., Assistant Professor of Medicine, Harvard Medical School;
Assistant in Medicine, Department of Nephrology, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-5050
55 Fruit Street, GRB 1003
Boston, MA 02114
THEODORE A. STERN, M.D., Professor of Psychiatry, Harvard Medical School; Chief,
Psychiatric Consultation Service, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-726-2984
55 Fruit Street, WRN 6
Boston, MA 02114
WILLIAM C. TAYLOR, M.D., Associate Professor of Medicine, Associate Master W.B.
Castle Society, Harvard Medical School; Senior Physician, Beth Israel Deaconess
Medical Center.
Department of Ambulatory Care Tel: 617-509-9871
and Prevention Email: william_taylor@hms.harvard.edu
Harvard Medical School and Harvard
Pilgrim Health Care
133 Brookline Avenue, 6th Floor
Boston, MA 02215
GEORGE H. THEODORE, M.D., Co-Director of Foot and Ankle Surgery, Harvard Medical
School; Assistant in Orthopaedic Surgery, Massachusetts General Hospital.
Massachusetts General Hospital Tel: 617-724-7009
Orthopedic Sport Medicine
175 Cambridge Street, Suite 400
Boston, MA 02114
MAY M. WAKAMATSU, M.D., Assistant Professor Harvard Medical School; Director, Division of Pelvic
Reconstruction Surgery and Urogynecology, Assistant in Gynecology, Massachusetts General
Hospital.
Massachusetts General Hospital Tel: 617-724-2183
Department of Gynecology Email: mwakamatsu@partners.org
55 Fruit Street, Yawkey 4E
Boston, MA 02114
XXV
28. LISA WEISSMANN, M.D., Clinical Instructor in Medicine, Harvard Medical School; Chief of
Hematology/Oncology at Cambridge Hospital, Attending Physician
Hematology/Oncology at Mount Auburn Hospital.
Mount Auburn Hospital Tel: 617-497-9646
330 Mount Auburn Street, Wyman 3 Email: lweissmann@rcn.com
Cambridge, MA 02238
RANDY WERTHEIMER, M.D., Lecturer, Harvard Medical School; Chairman of the
Department of Family Medicine, Cambridge Health Alliance.
Cambridge Hospital Tel: 617-665-1448
Department of Family Medicine Email: rwertheimer@challiance.org
1493 Cambridge Street
Macht Bldg., Room 422
Cambridge, MA 02139
JOHN WINKELMAN, M.D., Ph.D., Assistant Professor of Psychiatry, Harvard Medical
School; Medical Director, Sleep Health Center, Brigham and Women’s Hospital.
Sleep Health Center Tel: 617-783-1551 x119
1505 Commonwealth Avenue Email: jwwinkelman@partners.org
Brighton, MA 02135
BERTRAM ZARINS, M.D., Augustus Thorndike Clinical Professor of Orthopaedic Surgery,
Harvard Medical School; Emeritus Chief of Sports Medicine Service, Massachusetts
General Hospital.
Massachusetts General Hospital Tel: 617-726-3421
Department of Orthopaedic Surgery Email: bzarins@partners.org
175 Cambridge Street
Boston, MA 02114
JEFFREY L. ZILBERFARB, M.D., Assistant Clinical Professor in Orthopedic Surgery, Harvard Medical
School; Staff Orthopedic Surgeon, Beth Israel Deaconess Medical Center.
Meeks and Zilberfarb Orthopedic Tel: 617-232-2663
Associates Email: jzilberf@bidmc.harvard.edu
1101 Beacon Street, Suite 5 West
Brookline, MA 02446
XXVI
29. Primary Care Internal Medicine: Principles and Practice
Faculty Disclosures
Harvard Medical School has long held the standard that its continuing medical education courses be
free of commercial bias.
Now, in accord with the disclosure policy of the Medical School as well as standards set forth by the
Accreditation Council on Continuing Medical Education, speakers and their spouses/partners, and
planners have been asked to disclose any relationship they have to companies producing
pharmaceuticals, medical equipment, prosthesis, etc. that might be germane to the content of their
lectures. Please note that now in accordance with recent policies from the ACCME, relationships of
the person involved in the CME activity must include financial relationships of a spouse or partner.
In addition, faculty have been asked to list any off label uses, they will discuss, of
pharmaceuticals and devices for investigational or non-FDA approved purposes.
Such disclosure is not intended to suggest or condone bias in any presentation, but is elicited to
provide the course director and registrants with information that might be of potential importance to
their evaluation of a given talk.
The following speakers, spouses/partners, and planners have reported no significant
relationships with industry:
Nesli Basgoz, MD Lucia Larson, MD
Carol K. Bates, MD Aaron Lazare, MD
Michael F. Bierer, MD Bonnie T. Mackool, MD
Joanne Borg-Stein, MD James A. MacLean, MD
Traci L. Brooks, MD R. William Mason, MD
Virginia A. Capasso, PhD Mary McNaughton-Collins, MD
Jang-Ho Cha, MD Christopher Newton-Cheh, MD
Samuel H. Doppelt, MD Walter J. O’Donnell, MD
Sukran Ergin, MD J. Carl Pallais, MD
Vera T. Fajtova, MD Richard J. Pels, MD
Christopher H. Fanta, MD Claudia U. Richter, MD
Laura C. Fine, MD Edward T. Ryan, MD
Elizabeth Gaufberg, MD Martin A. Samuels, MD
Thomas J. Gill, MD Kitt Shaffer, MD
Frederic M. Goldman, MD Christine A. Sinsky, MD
John D. Goodson, MD Thomas A. Sinsky, MD
Charles J. Hatem, MD Gerald W. Smetana, MD
G. Sherry Haydock, MD David J. R. Steele, MD
James J. Heffernan, MD William C. Taylor, MD
Eliot C. Heher, MD George H. Theodore, MD
Daniel P. Hunt, MD May M. Wakamatsu, MD
Eric M. Isselbacher, MD Lisa Weissmann, MD
Julie Jolin, MD Randy Wertheimer, MD
William M. Kettyle, MD Bertram Zarins, MD
David J. Kuter, MD Jeffrey L. Zilberfarb, MD
XXVII
30. The following speakers, spouses and planners, have reported receiving something of value*
from a company whose product may be germane to the content of their presentations:
NAME COMPANY RELATIONSHIP
Alireza Atri, M.D. Forest Laboratories Consultant and/or speaker, investigation initiated
research study
Pfizer Consultant and/or speaker
Novartis Consultant and/or speaker
Eisai Inc. Consultant and/or speaker
Elan Clinical trials
Whyeth Pharmaceuticals Clinical trials
Eli Lilly & Co. Clinical trials
Michael J. Barry, MD Foundation for Informed Grantee through Massachusetts General
Medical Decision-Making Hospital
(A not-for-profit)
David W. Chen, MD GlaxoSmithKline Speakers bureau
Susan Edgman-Levitan, PA National Committee for Quality PC –Practice Recognition Advisory Committee
Assurance
Trust for Healthcare Excellence Board member
Anne R. Fabiny, MD Novartis Consultant
Rose H. Goldman, M.D. Reports serving as a paid expert witness, independent medical examiner, and/or
consultant in workers’ compensation and disability cases on occupational medicine
and environmental health, on some topics that might be covered in her workshop.
New England Pediatric Grant recipient
Environmental Health Specialty
Unit – Co-Director
Michael R. Jaff, DO Abbott Vascular Consultant, research support
Pathway Medical Consultant
Paragon IP Consultant
Harvard Clinical Research Institute Consultant
Bacchus Vascular, Inc. Consultant
Baxter, Incorporated Consultant
Micelle, Incorporated Consultant
I.C. Sciences, Incorporated Consultant
FlexStent, Incorporated Consultant
Hypermed, Incorporated Consultant
Access Closure, Inc. Equity
Square One, Inc. Equity
Vascular Therapies, Inc. Equity
Icon Interventional, Inc. Equity
Setagon Equity
Sadra Medical Equity
Genzyme Research support
VIVA Physicians Board member
Lee M. Kaplan, MD Merck Research Labs Sponsored research
GI Dynamics Sponsored research
Gelesis Scientific advisor
XXVIII
31. Johnson & Johnson Scientific advisor
C. R. Bard Consult
Ciarán P. Kelly, MD Alvine Consultant and scientific advisor
Alba Research grant support
Joshua Korzenik, M.D. Proctor & Gamble Consultant, research, speaker
Shire Pharmaceuticals Consultant
VCB, Salix Pharmaceuticals Consultant, speaker
ViroPharma Research
R. William Mason, MD Enhanced Auditory Resources Medical Director
Peter A. Merkel, M.D. Abbott Research and/or educational activities
Actelion Research and/or educational activities
Amgen Research and/or educational activities
Aspreva Research and/or educational activities
Biogen-Idec Research and/or educational activities
Bristol Myers Squibb Research and/or educational activities
Celgene Research and/or educational activities
Centocor Research and/or educational activities
Encysive Research and/or educational activities
Genentech Research and/or educational activities
Genzyme Research and/or educational activities
Novartis Research and/or educational activities
Regeneron Research and/or educational activities
Takeda Research and/or educational activities
American College of
Rheumatology Research and/or educational activities
Cystic Fibrosis Foundation Research and/or educational activities
European League Against
Rheumatism Research and/or educational activities
National Institutes of Health Research and/or educational activities
(NIAMS•NIAID•NCRR•ORD)
Scleroderma Foundation Research and/or educational activities
US Food and Drug
Administration Research and/or educational activities
The Vasculitis Foundation Research and/or educational activities
Albert G. Mulley, MD Foundation for Informed Consultant, editor, grant recipient
Medical Decision-Making
Health Dialog, Inc. Editor, royalty recipient
David M. Nathan, MD Sanofi-Aventis Research grant
Roy H. Perlis, MD Astra Zeneca Consultant/honoraria, speaker fees
Bristol Myers-Squibb Consultant/honoraria, speaker fees
Eli Lilly & Co. Consultant/ Honorarium, speaker fees
GlaxoSmithKline Consultant/honorarium, speaker fees
Pfizer Consultant/honorarium, speaker fees
Proteus Consultant/honorarium
Concordant Rater Systems, LLC Major stockholder
Jeremy Ruskin, MD Astellas Consultant
Biosense Webster Consultant
Cardiome Consultant
XXIX
32. CV Therapeutics Consultant
Medtronic Consultant
Pfizer Consultant
Sanofi Aventis Consultant
Solvay Consultant
Sterectaxis Consultant
Boston Scientific/Guidant Speaker at Fellows’ Programs
St. Jude Medical Speaker at Fellows’ Programs
CardioFocus Clinical Oversight Committee
CryoCath Scientific Steering Committee
David P. Ryan, MD Sanofi Honorarium
Roche Honorarium
Lee H. Schwamm, MD CoAxiia Consultant
CryoCath Consultant
Jan L. Shifren, MD Procter & Gamble Research support
Pharmaceuticals
Boehringer Ingelheim Research study consultant
New England Research
Institutes Scientific advisory board
Eli Lilly & Co. Research study consultant
Theodore A. Stern, M.D. Janssen Consultant
Eli Lilly Consultant
Forrest Speaker review
WiFiMed Holdings Company, Inc. Shareholder
Mosby Elsevier Royalty fees
McGraw-Hill Royalty fees
John W. Winkelman, MD Boehringer-Ingelheim Speakers bureau, advisory board, research support
GlaxoSmithKline Speakers bureau, advisory board
Sanofi-Aventis Speakers bureau
Sepracor Speakers bureau, research support
Takeda Speakers bureau, advisory board
Axon Labs Advisory board
Jazz Pharmaceuticals Advisory board
Novartis Advisory board
Neurogen Advisory board
Pfizer Advisory board
UCB Pharma Advisory board, research support
*"Something of value" refers to an equity position, receipt of royalties, consultantship, funding by a
research grant, receiving honoraria for educational services elsewhere, or to any other relationship to
a company that provides sufficient reason for disclosure, in keeping with the spirit of the stated policy.
XXX
33. Primary Care Internal Medicine: Principles and Practice
Monday, October 20, 2008
General Session
7:00 Registration
7:45 Introduction John D. Goodson, M.D.
8:00 Medical headlines 2008: Evaluating recent John D. Goodson, M.D. 1
“evidence” for clinical practice *
9:00 Advanced treatment choices for ischemic Eric M. Isselbacher, M.D. 25
heart disease
10:00 Coffee break
10:20 Anticoagulation in practice David J. Kuter, M.D. 39
11:20 Peripheral vascular disease Michael R. Jaff, D. O. 109
12:20 Session ends, lunch break
1:30 Sleep disorders John Winkelman, M.D. 145
2:15 Approaches to depression Roy H. Perlis, M.D. 157
3:00 Break
Workshop Sessions A and B
(Refer to Workshop Syllabus)
3:20 Case-Based Workshop Sessions A – Breakout Rooms
4:30 Break
4:45 Case-Based Workshops Sessions B – Breakout Rooms
6:00 Daily Program Ends
* Meets criteria for Risk Management credit in Massachusetts
34. Medical headlines 2008: Evaluating
recent “evidence” for clinical practice
John D. Goodson, M.D.
35. John D. Goodson, M.D.
Primary Care Internal Medicine:
Principles and Practice 2008
MEDICAL HEADLINES 2008: EVALUATING RECENT
“EVIDENCE” FOR CLINICAL PRACTICE
Learning objectives:
1. Our work is predicated on the acquisition of information.
a. Filtering: The elimination of information that is not relevant.
b. Integration: The incorporation of new information into your knowledge-base.
2. There is a hierarchy of information acquisition.
a. Case control studies allow the quick assessment of associations. Findings can
be critical “warning lights” in medical practice but do not establish causality.
b. Cohort studies allow a nuanced assessment of associations. Results are more
robust because adjustments for confounding can be made more reliably, but do not
establish causality.
c. Randomized Control Trials (RCTs) allow the determination of causality
through experimentation.
d. Meta-analysis allows the pooling of similar results in order to get a more precise
statement of association or causality, depending on the types of studies combined.
3. The sources of our “expert opinions” (AKA “Guidelines”) must consistently achieve
information standards (from USPSTF).
a. Transparency: Information publicly available and accessible.
b. Accountability: All potential conflicts noted and subject to peer review.
: Conclusions are tested with additional study if needed.
c. Consistency: All conflicting findings resolved or addressed.
d. Independence: Stake holder roles specified and explained.
1
36. 2007 – 2008 Medical Headlines
1. Generalist physicians now responsible for patients with life
threatening heart ailment.
2. Common procedure useless.
3. Patient education fails.
4. Milk heals bones.
5. Radical surgery prevents cancer.
6. Common medicine ruins bones.
I. Randomized controlled trials (RCTS)
Example 1: Should AF be managed by rate control?
In 2008 Roy, et al (representing the Atrial Fibrillation Congestive Heart Failure Investigators)
reported the results of a randomized trial comparing rhythm control (maintenance of sinus
rhythm) and rate control in patients with EF < 35%, symptoms of CHF. 123 clinical centers
(North and South America, Europe, Israel), 1376 patients, 37 month follow-up. Rhythm control
verses rate control for atrial fibrillation and heart failure. N Engl J Med 2008; 358:2667-77.
AF: Rhythm vs. rate
Baseline patient characteristics
(N=1376)
Rhythm Rate
Male, % 78 85
Age, yr 66+/-11 67+/-11
BMI 27.8+/-5.4 28.0+/-5.1
NYHA
Class III or IV,
6 mos, % 76 76
EF, % 27+/-6 27+/6
Persistent AF, % 67 70
Medications, %
Digoxin 64 65
B Blocker 80 78
ACEI/ARB 97 97
Warfarin 86 90
2
37. AF: Rhythm vs. rate
Interventions+
Rhythm Rate
Amiodarone 82 7
Sotalol 2 <2
B Blocker 80 88
Digoxin 51 75
+ P < 0.05 for all differences
AF: Rhythm vs. rate
Outcomes
Death
AF: Rhythm vs. rate
Outcomes
Worsening CHF
3
38. AF: Rhythm vs. rate
Outcomes
Composite Outcome
(N Engl J Med 2008;358:2667-2727)
Randomized Control Trials – Our Gold Standard
Randomized control trials
Disease
Present Absent Event Rate
Exposure A B A
Patients (A+B)
Control C D C
(C+D)
Exposure Event Rate (EER) = A
(A+B)
C
Control Event Rate (CER) = (C+D)
Absolute Risk Reduction (ARR) = CER – EER
Relative Risk Reduction (RRR) = (CER – EER) CER = ARR CER
1
Number Needed to Treat (NNT) = ARR
4
39. Key terms
Sampling: The selection of clinical material for study. A sample may or may not represent
the entire population.
Observation: The careful collection of information relative to diseased and non-diseased
states, which may or may not have influenced outcome.
Experimentation: The control of conditions, which may or may not influence outcome.
Bias: A systematic error in data collection.
Confounding: An error of inference, the mistaken conclusion that there is causation
where there is none.
Generalizability: The extent to which study results can be expected to occur in other
populations.
The Randomized Controlled Trial (RCT): Patients are randomly assigned to receive or not to
receive an intervention and are followed prospectively for the development (or lack of
development) of disease during an observation period.
1. How were patients selected for entry into the study? Do the patients represent the disease
spectrum or just one segment? If it is one segment, what were the characteristics used to
identify eligible cases? How generalizable are the results?
2. Were patients and physicians blinded to the intervention? Could physician or patient
knowledge of the intervention (or lack of intervention) significantly influence the
outcome?
3. Is the intervention clearly defined? Is it quantified as to the intensity and duration?
4. Is the intervention feasible? Does the risk, expense or inconvenience of the intervention
interfere with application?
5. Were all patients accounted for at the conclusion of the study? Was there any reason why
patients might drop out of either the exposed or non-exposed group more readily?
6. How were outcomes defined? Does the definition of disease meet specific and reasonable
practice standards?
Example 2: Does arthroscopic surgery work for osteoarthritis of the knee?
The randomized control trial (RCT): In 2002 Moseley, et al. (N Engl J Med 2002; 347: 81-88)
reported the results of a RCT involving 180 patients from the Houston VAMC. Patients were all
< 75 years of age and had at least “moderate pain” (score > 4/10 on visual analogue scale). 44%
of 324 consecutive eligible patients declined to participate. 180 patients were randomly assigned
to these interventions: arthroscopic debridement, arthroscopic lavage, and placebo surgery. There
was no difference in outcome at 24 months.
5
40. RCT of arthroscopic surgery for knee OA
Patient characteristics
Placebo Lavage Debridement
Age, yrs 52+/-11.1 51.2+/-10.5 53.6+/-12.2
Male, % 93.3 88.5 96.6
OA seventy
Mild 28.3 27.9 30.5
Moderate 46.7 45.9 45.8
Severe 25.0 26.2 23.7
Prescription analgesic
use, % 21.7 21.3 15.3
Outcomes from RCT of arthroscopic surgery for knee OA
- - - Debridement
― ― Lavage
¾ Placebo
Example 3: Does diabetic patient education and home monitoring improve HbA1c levels?
In 2007 Farmer, et al (representing the UK’s Diabetes Glycaemic Education and Monitoring Trial
Group) reported the results of a RCT of patients with Type II DM on oral agents comparing 3
interventions: Usual care (quarterly office visits), home blood glucose monitoring (HBGM) with
instructions to call for advice (passive supervision), HBGM with additional training and lifestyle
interventions (active supervision). 48 generalists practices, 453 patients, 12 month follow-up.
BMJ 335 (7611):132-139, July 21, 2007.
6
41. HBGM in Type II DM
Baseline patient characteristics
(N=453)
Control HBGM, HBGM,
Passive Active
Age, yrs 66.3+/-10.2 65.2+/-10.6 65.6+/-9.9
Male, % 55.9 58.7 57.6
Therapies, %
Diet 28.9 26.0 27.2
Monotherapy 37.5 38.7 38.4
Combined oral 33.6 35.3 34.4
BMI 30.9 31.9 31.0
HbA1c 7.49 7.41 7.53
HBGM in Type II PDM
Patient Outcomes
Patient adherence declined
HBGM in Type II PDM
Patient Outcomes
No improvement of HbA1c
7
42. Example 4: How generalizable are RCT results?
In 2008 Dhruva and Redberg reported a comparison of the patient characteristics in clinical trials
used by Medicare to assess technology and the Medicare population. Clinical trial participants
were more likely to be male (75.4% vs. 41.8%), younger (60.1 years vs. 74.7 years) and non-US
residents (60% vs. 0%). Arch of Inter Med 2008; 168:136-140.
Medicare technology assessments (TA)
are based on non Medicare demographics
TA patients are younger
Medicare technology assessments (TA)
are based on non Medicare demographics
TA patients more likely to be male
8
43. II. Meta-analysis
Example 1: Calcium reduces osteoporosis.
In 2007 Tang, et al. reported a meta-analysis of 29 RCTs (published and unpublished). Combined
data from 17 studies showed a fracture risk reduction of 12%. Lancet 2007; 370:657-666
Meta-analysis of calcium supplements and fracture risk
7867 References screened
274 Abstracted for assessment
59 Fully reviewed
29 Analyzed
17 With fracture outcomes (others had BMD only)
combined in meta-analysis
Meta-analysis of calcium supplements and fracture risk
(Lancet 2007; 370:657-666)
Meta-analysis of calcium supplements and fracture risk
Cumulative meta-analysis
(Lancet 2007;370:657-666)
9
44. Meta-analysis: The pooling of results from studies to achieve a more accurate estimate of effect.
The process involves three steps: (1) the selection of the component studies; (2) the pooling of
results; and (3) the examination of how sensitive the results are to methodologic differences.
1. The selection of component studies
a. An exhaustive and comprehensive search of the published (and in some cases,
unpublished) literature.
b. Identification of outcomes that can be assessed in each study.
c. Selection of studies, by defined criteria, which can be combined, i.e. similar
interventions and outcomes measures.
d. Identification and notation of the methodological differences in patients, study
designs, interventions, outcomes measures and other confounders, which might
alter the results.
2. Pooling of results
a. Combined studies should be tested for homogeneity, i.e. that the differences in
results are statistically insignificant.
b. Differences should be biologically plausible.
3. Sensitivity analysis
a. The pooled results should be analyzed according to differences in patients, study
designs, interventions, outcomes and other possible confounders.
Homogeneity
Outcome Rate
Control
Control
(Ann Intern Med 1987;107:229)
10
45. Heterogeneity
Control
(Ann Intern Med 1987;107:227)
Example 2: Are long acting ß-agonists harmful for asthmatic patients?
1. Meta-analysis: In 2006 Salpeter, et al. (Ann Intern Med 2006;144:905-912) reported the
results of a meta-analysis of 19 published clinical trials involving 33826 patients. Long
acting inhaled ß-agonists were associated with a 2.6 times increased risk vs. placebo for
hospitalizations from asthma exacerbation.
ß-agonist use and increased risk for asthma related hospitalization
(Ann Intern Med 2006;144:908)
11
46. Example 3: Do antioxidant vitamin supplements increase mortality?
1. Meta Analysis: In 2007 Bjelakovic, et al (JAMA 2007;297:842-854) reported a meta-
analysis of 68 RCTs involving beta carotene, Vitamin A, Vitamin C, Vitamin E and
selenium alone or in combination . In 47 “low bias” trials, beta carotene, Vitamin A and
Vitamin E all increased mortality. Vitamin C and selenium were neutral.
Vitamin supplements can increase mortality
Odds Ratio
(95% C.I.)
Selenium 1.07 (1.04 – 1.10)
Beta Carotene 1.09 (1.06 – 1.13)
Vitamin A 1.20 (1.12 – 1.29)
Vitamin C 1.06 (0.99 – 1.14)
Vitamin E 106 (1.01 – 1.10)
Example 4: Does rosiglitazone increase risk for MI?
1. Meta-analysis: In 2007 Nissen, et al (N Engl J Med 2007;356:2457-2471) searched the
publicly accessible clinical data files of GalaxoSmithKline, the FDA and the published
literature. 42 RCTs were analyzed. The odds ratio for MI was 1.43 (95% C.I. 1.03 –
1.98).
Rosiglitazone increases MI risk
Rosiglitazone Placebo
Combined small trials 0.0012 (44/10280) 0.0036 (22/6105)
DREAM 0.0057 (15/2635) 0.0034 (9/2634)
ADOPT 0.0185 (27/1456) 0.0141 (41/2895)
Overall odds ratio 1.43 (95% C.I. 1.03 – 1.98)
Key point:
Homogeneity of study findings is what “allows” pooling.
III. Cohort Studies
Example 1: In 2007 Sjostrom, et al (reporting the Swedish Obese Subjects Study) reported the
outcomes from various interventions for obesity from 25 surgical departments. 4047 patients
were followed over 10.9 years, 2010 underwent bariatic surgery. The surgical group had 24%
reduction in mortality. N Engl J Med 2007; 357:741-752.
12
47. Swedish obese patient cohort
Baseline patient characteristics
Surgery Conventional
Age, yrs 47.2+/-5.9 48.7+/-6.3
BMI 42.4+/-4.5 40.1+/-4.7
Female, % 71 71
Swedish obese patient cohort
Patient outcomes
Weight loss
0 +/- 2%
20+/-10%
25+/-9%
32+/-8%
(N Engl J Med 2007; 357:741-752)
Swedish obese patient cohort
Patient outcomes
Mortality
24% mortality
reduction
(N Engl J Med 2007; 357:741-752)
13
48. Cohort studies
Disease
Present Absent
Exposure A B
Patient
No exposure C D
A C
Risk Ratio (RR) = ( /(A+B) / ( /(C+D)
The Cohort Study: Patients differing in exposure to one or a group of factors are followed for the
development of disease. After a period of observation, the relative (and in some cases, the
absolute) risk of disease in the exposed and non-exposed groups can be calculated.
1. Are the exposed and non-exposed groups similar in other ways? Can the different
outcomes in the two groups be explained by the presence or absence of other factors?
2. Is exposure clearly defined? Is the factor isolated for study quantified as to intensity and
duration of exposure?
3. Were all cohorts monitored equally? Was there any difference in the availability of
information from one group, which might have influenced the detection or development of
the disease?
4. How many patients dropped out or were lost to follow- up and why? Could there have
been any characteristics of the dropouts directly related to the presence or absence of
disease?
5. Were outcomes uniformly and clearly measured? Does the definition and detection of
disease meet specific and reasonable practice standards?
IV. Case Control Studies
Example 1: Do PPIs increase the risk of osteoporosis?
1. The case-control method: In 2006 Yang, et al. (JAMA 2006; 296:2947-2953), compared
13,556 patients with hip fracture from the UK’s General Practice Database (2003) with
135,386 matched (sex, age, follow-up) patients without hip fracture. The adjusted odds
ratio for long term, high dose PPI users was 2.65 (95% C.I., 1.80 – 3.90).
14
49. High dose (over 175% average dose), long term (over 1 year)
PPI use associated with hip fracture risk
Hip fracture Control
> 175% average 37 123
daily dose
< 175% average 534 3228
daily dose
Adjusted Odds Ratio = 3.18 (95% C.I. – 2.20 – 4.60)
Case-control studies
Patients Patients
Disease
Present Absent
Exposure A B
C D
No Exposure
(A/B) AD
Odds Ratio = (C/D) = BC
The Case-control study: Data from patients with a disease are compared with data from similar
patients without the disease. The risk conferred by an exposure in the disease group relative to
the control group can be calculated.
1. How were cases and controls selected? Was there a bias in the selection process, which
would increase or decrease the relative risk of the exposure?
15
50. 2. Do the cases adequately represent the disease spectrum? Did the case selection process
choose only certain types of diseased patients?
3. Is the exposure clearly defined? Is the factor isolated for study quantified as to intensity
and duration of exposure?
4. How was data collected from cases and controls? Was information more intensively
sought or more readily available in one group than the other?
Key points:
Information bias: Data more intensively sought or readily available in case or control group.
Selection bias: Case or control selection related to exposure status.
Key point:
Case-control studies are “warning lights” on the control panel of medicine. They allow a
quick determination of association and alert us about potential causal relations.
Key point: Cohort studies allow a more nuanced determination of association and alert us to
potential causal relations.
Key point:
Establishing causality is not possible with either case-control or cohort studies. However, the
likelihood of a causal relationship is enhanced if the following are demonstrated.
a. Replication by other investigators
b. Consistency in multiple strata
c. Dose/exposure variation.
d. Biologic/physiologic plausibility
V. Number needed to treat (NNT): the number needed to treat to prevent one bad outcome, the
reciprocal of the absolute risk reduction (1/ARR).
NNT illustrates the relative work effort needed to get benefit from different interventions.
Can help clinicians to understand the number of effective management interventions that will be
needed in a group of patients to achieve a given outcome for one of the group.
Example 1: Does aggressive LDL lowering improve outcomes in patients with acute coronary
syndromes?
NNT: In 2004, Canon, et al. (N Engl J Med 2004;350:1495 – 1504) reported the results of a RCT
involving 4162 patients within 10 days of an acute coronary syndrome. Half received pravastatin,
16
51. 40 mg/day, and half atorvostatin, 80 mg/day. Patients were followed for an average of 24
months. LDL levels fell to 95 mg/dl in the pravastatin group and 62 mg/dl in the atorvostatin
group. There were 16% fewer events (death, MI, CABGs, PTCAs, CVAs) the atorvostatin group.
Intensive LDL reduction in Acute Coronary Syndrome (ACS):
Baseline patient characteristics (2004)
40 mg Pravastatin 80 mg Atorvostatin
Age, yrs 58.3 58.1
Male, % 78.4 77.8
White, % 90.4 91.0
Smoker, % 37.1 36.4
HTN, % 49.2 51.3
DM, % 17.5 17.8
LDL, mg/dl 106 106
HDL, mg/dl 39 38
Intensive LDL reduction in Acute Coronary Syndrome (ACS):
Treatment results
LDL
Pravastatin 95 mg/dl
Atorvostatin 62 mg/dl
Intensive LDL reduction in Acute Coronary Syndrome (ACS):
Outcomes (death, MI, CABGs, PTCAs, CVAs)
Event Rate Risk Reduction Absolute RR NNT
Pravastatin Atorvostatin
26.3% 22.4% 16% 3.9% 26
Example 2: In 2005, Halvorsen and Kristiansen (Arch of Intern Med 2005;165:1140-1146)
reported a population survey from 1201 Norwegians with different scenarios relating to disease
prevention. Patients were asked to consent to hypothetical intervention. Consent ranged from 76-
67% when the NNT ranged from 50 to 1600 (NS).
Number needed to treat and consent for therapy
(Norwegian study, N=1201)
Magnitude of NNT Consent (%)
50 53
200 49
800 44
1600 50
17
52. Disease
Lethal disease 65
Stroke 54
MI 47
Hip fracture 31
(Arch Intern Med 2005;165:1140-1146)
VI. Application of evidence in practice
A. Hierarchy of processed evidence (after Guyatt et al, in JAMA 2000; 248:1290-1296).
“Processing” evidence
Primary Studies Summaries Guidelines
RCTs Meta-analyses
Cohort studies
Case control studies Validation
RCTs
Meta-analyses
B. Practice guidelines: “Systematically developed statements to assist practitioner and
patient decisions about appropriate health care for specific clinical circumstances” (IOM –
1990).
1. Methods of development
a. Informal: systematic assessment of expert opinion.
b. Evidence-based: structural review of published and unpublished literature,
expert assessment of data, consensus development, identification of “gray
zones.”
2. Limitations
a. The database may be insufficient (e.g. limitations by age, ethnicity, follow-
up duration).
b. Interventions may be unfeasible (e.g. technology not available or too
costly).
c. Recommendations may not recognize patient preferences (e.g. level of risk
aversion).
d. Recommendations may not be specific enough (e.g. the unique
circumstances of each patient).
18
53. C. Conflict of interest
1. In 2002 Choudhry, et al. (JAMA 2002; 287:612-617) reported the results of a
survey of 192 authors of 44 clinical practice guidelines published 1991 –1999.
52% of authors responded.
Clinical practice guidelines and pharmaceutical industry relationships
Any relationship with industry 87%
Travel/speaking 53%
Educational program support 51%
Employment 38%
Key points: Guidelines are only as good as the data and the process.
D. Influence of data on practice
1. Cohort study: In 2004 Haas, et al. (Ann Intern Med 2004; 140:184-188) reported
hormone use patterns for 71219 women in the San Francisco Mammography
Registry. After the 2002 publication of the WHI report, hormone use declined in
rate of 18% per quarter.
Hormone use by Bay Area women after HERS and WHI publications 2003
WHI (2002)
HERS (1998)
(Ann Intern Med 2004;140:186)
E. Balance in practice
Daily practice requires assigning value to all elements of clinical decision- making: Data
(clinical, physiologic, etc.), preferences (patient, physician), risks (medical, surgical,
financial), costs (resources, dollars).
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