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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
 
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
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
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
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
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
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
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
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
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
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
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
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
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
 
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Medical headlines 2008: Evaluating
recent “evidence” for clinical practice


       John D. Goodson, M.D.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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General Session

  • 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). 19