2014 Annual District Meeting

FLORIDA 2014 Annual District Meeting Recent Advances & Current Trends in OB/GYN August 15-17, 2014 The Ritz-Carlton Orlando, Grande Lakes Orlando, FL...
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FLORIDA

2014 Annual District Meeting Recent Advances & Current Trends in OB/GYN August 15-17, 2014 The Ritz-Carlton Orlando, Grande Lakes Orlando, FL

SYLLABUS

www.obgpathways.com

The American Congress of Obstetricians and Gynecologists District XII Florida Welcome CHAIR Robert W. Yelverton, MD

  Dear Colleagues and Guests, 

VICE CHAIR Karen E. Harris, MD, MPH

As the District XII Chair it is a great honor to welcome you to the  second ACOG District XII Annual District Meeting (ADM). The last year and  a half have been a very busy, yet exciting time for District XII. Our  inaugural meeting last August was a huge success.  I am thrilled about this  year’s meeting, as your planning committee has put together another  great program filled with terrific lectures and phenomenal speakers. In  addition to a great scientific program planned, there is plenty to do both     socially as well as locally. 

TREASURER Guy I. Benrubi, MD SECRETARY Shelly Holmstrom, MD IMMEDIATE PAST CHAIR Alfred H. Moffett, MD LIASON TO THE JUNIOR FELLOWS Cole Greves, MD

  It is my hope that our ADM will allow you and your fellow colleagues the opportunity to  learn more about recent advances and current trends in Ob/Gyn. The District XII scientific  program committee has thoughtfully designed this year’s program to offer a wide selection  of clinical topics, including lectures on the annual exam, preterm births and infant mortality,  an “expert debate” on ovarian cancer treatment and a plenary session on PCOS that will be  shared with the Florida Society of Reproductive Endocrinology and Infertility. I also hope you  will take time to network with colleagues as well as the 70+ companies that will also be  exhibiting at the meeting.   In addition to the educational program and social activities we have planned, I am thrilled  that the ACOG President‐John Jennings, MD and VP of Health Policy and Advocacy‐Barbara  Levy, MD will also be joining us for the 2014 ADM.   Although there is a lot planned for this weekend, I hope that you will find some down time  to enjoy The Ritz as well as the local Orlando attractions. Finally, if you have not already  made plans to attend the Saturday evening Citrus Garden Dinner, you may want to  reconsider. Following the dinner the evening will continue on at the "After Party!" Challenge  your friends and colleagues to some friendly competition with giant life‐size games like  Connect Four®, Jenga® or Corn Hole. The After Party will also feature a DJ and a cash bar. So,  make plans today to attend ‐ there is no fee for you or your guest to attend; you just have to  be willing to let your "inner kid" out for a late night of fun and games!  On behalf of the entire District XII Advisory Council, thank you for attending, we hope it is a  great meeting and we will look forward to many more!  Sincerely, 

Robert W. Yelverton, MD  ACOG District XII, Chair 

 

6816 Southpoint Pkwy, Suite 1000, Jacksonville, FL Main: (904) 309-6265 Fax: (904) 998-0855 [email protected]

PROGRAM AGENDA The Scientific Sessions will be held in Tuscany A-D, unless otherwise noted below. Friday, August 15 7:00 AM‒6:30 PM

REGISTRATION OPEN Location: Plaza Ballroom Foyer Session Moderator: Karen Harris, MD

1:15–1:30 PM

Welcome/Introductions/Housekeeping

1:30–2:15 PM

Emotional Intelligence Patrice M. Weiss, MD

2:15–3:00 PM

Hypertensive Crisis in Pregnancy Management James N. Martin, Jr., MD

3:00–3:30 PM

Q&A Session

3:30–3:45 PM

BREAK Location: Tuscany Foyer Session Moderator: JK Williams, MD

3:45–5:30 PM

Resident Research Presentations

5:30–6:00 PM

ACOG District XII Junior Fellows Business Meeting Location: Verona II Session Moderator: John Diaz, MD

5:30–6:30 PM

Smoking and Reproductive Health Jorge J. Garcia, MD

6:30–8:00 PM

WELCOME RECEPTION WITH EXHIBITORS Location: Ritz-Carlton Ballroom

Saturday, August 16 7:00–7:45 AM

REGISTRATION/BREAKFAST WITH EXHIBITORS Location: Plaza Ballroom Foyer/Ritz-Carlton Ballroom

7:45–8:00 AM

Welcome/Introductions/Housekeeping Session Moderator: Karen Harris, MD

8:00–8:35 AM

Preterm Birth & Infant Mortality—The Obstetrician’s Responsibility Jay D. Iams, MD

8:35–9:10 AM

Managing Abnormal Pap Smears—Incorporating Biomarkers and New Guidelines into Your Practice Ashlyn H. Savage, MD, MSCR

Session Moderator: Steven Ory, MD

9:10–9:45 AM

Access to Abortion David A. Grimes, MD

9:45–10:00 AM

Q&A Session

10:00–10:30 AM

BREAK WITH EXHIBITORS Location: Ritz-Carlton Ballroom

10:30–11:15 AM

BREAKOUT SESSIONS Session Moderator: Suzanne Bush, MD

The Girlology Experience: Changing the Culture of Sexuality Education Melisa Holmes, MD Location: Tuscany F Session Moderator: John Diaz, MD

DEBATE Neoadjuvant Chemotherapy for Advanced Ovarian Cancer—Is Cytoreduction Overrated? Ricardo Estape, MD Primary Debulking Surgery vs. Neoadjuvant Chemotherapy Dennis S. Chi, MD Location: Tuscany A-D Session Moderator: Karen Harris, MD

HIPPA/HITECH and OB/GYNS-What You Must Know About Patient Privacy and Data Security in 2014 Aldo M. Leiva, JD

Location: Tuscany G 6 11:20 AM–12:00 PM

JOINT PLENARY SESSION WITH FSREI Session Moderator: Steven Ory, MD

Polycystic Ovary Syndrome: From the Stein Age to the Present Richard S. Legro, MD 12:00–12:30 PM

Update from ACOG President John Jennings, MD

12:30–1:00 PM

ACOG District XII Annual Business Meeting

1:00–2:15 PM

Legislative Luncheon Location: Tuscany Ballroom E

2:15–3:00 PM

DESSERT RECEPTION WITH EXHIBITORS Location: Ritz-Carlton Ballroom

2:45–4:45 PM

Medical Student Skills Session Location: Tuscany F & G

7:00–10:00 PM

CITRUS GARDEN DINNER Location: Citrus Garden

9:00-11:00 PM

THE AFTER PARTY Location: Amalfi II

Sunday, August 17 7:00–7:30 AM

BREAKFAST Location: Tuscany Ballroom E

7:30–7:45 AM

Welcome/Introductions/Housekeeping STATE MANDATED COURSES Session Moderator: R. Stan Williams, MD

7:45–8:45 AM

Intimate Partner Violence (IPV) and the Medical Community Teresa A. Drake, JD

8:45–9:45 AM

Prevention of Medical Errors Donald Wood, ARNP, CRNA, LHRM

9:50–10:35 AM

BREAKOUT SESSIONS Session Moderator: Jerome Yankowitz, MD

Social Media and Your Practice William Hambsh, CPA, CPME, MACC Location: Genoa II Session Moderator: Steven Ory, MD

Screening Tests: How to Ruin a Perfectly Good Marriage David A. Grimes, MD Location: Tuscany A-D Session Moderator: Suzanne Bush, MD

Centering Pregnancy—Benefits for Your Practice Julie Zematis DeCesare, MD Location: Amalfi Session Moderator: Karen Harris, MD

10:40–11:20 AM

The Annual Exam—If Not for Pap Smear, Then What? Ashlyn H. Savage, MD, MSCR Session Moderator: John Diaz, MD

11:20–11:55 AM

Update in the Management of Ovarian Cancer Dennis S. Chi, MD

11:55 AM–12:30 PM

HPV Vaccine—An Opportunity for Prevention in Men Elissa Meites, MD, MPH

12:30–12:45 PM

Q&A Session

12:45 PM

Meeting Adjourns

FACULTY/PLANNING COMMITTEE NATIONALLY FEATURED FACULTY Dennis S. Chi, MD Gynecology Service Department of Surgery Memorial Sloan-Kettering Cancer Center New York, NY Julie Zemaitis DeCesare, MD Clinical Associate Professor OBGYN Residency Program Director Florida State University-College of Medicine Pensacola, FL Ricardo Estape, MD Voluntary Associate Professor University of Miami Miller School of Medicine South Miami Gynecologic Oncology Group Miami, FL Jorge J. Garcia, MD committee *Chair of the planning Clinical Assistant Professor Department of Obstetrics and Gynecology University of Miami Miller School of Medicine Miami, FL David A. Grimes, MD Clinical Professor Department of Ob/Gyn University of North Carolina School of Medicine Chapel Hill, NC Melisa Holmes, MD Founder Girlology & Guyology Simpsonville, SC Jay D. Iams, MD F. P. Zuspan Professor Emeritus of Obstetrics and Gynecology The Ohio State University Wexner Medical Center Columbus, OH

Richard S. Legro, MD Professor Department of Obstetrics and Gynecology Penn State University College of Medicine Hershey, PA James N. Martin, Jr., MD Professor of Obstetrics and Gynecology Vice Chair Research/Academic Development Chief of Maternal-Fetal Medicine The University of Mississippi Medical Center Jackson, MS Elissa Meites, MD, MPH Medical Officer Division of STD Prevention Centers for Disease Control and Prevention Atlanta, GA Ashlyn H. Savage, MD, MSCR Assistant Professor Obstetrics and Gynecology Medical University of South Carolina Charleston, SC Patrice M. Weiss, MD Chair and Professor Department of Obstetrics and Gynecology Carilion Clinic/ Virginia Tech Carilion School of Medicine Roanoke, VA ADJUNCT FACULTY Teresa A. Drake, JD Director The Source Program University of Florida-Levin College of Law Gainesville, FL William Hambsh, CPA, CMPE, MACC Chief Executive Officer Practice Administrator

Aldo M. Leiva, JD Partner Chair, Data Security and Privacy Practice Lubell & Rosen, LLC. Coral Gables, FL Donald Wood, ARNP, CRNA, LHRM Patient Safety/Risk Manager The Doctors Company Jacksonville, FL PLANNING COMMITTEE Suzanne Bush, MD Florida State University Pensacola, FL John Diaz, MD University of Miami-School of Medicine Miami, FL Karen Harris, MD, MPH North Florida Regional Medical Center Gainesville, FL James Mayer, MD University of South Florida Tampa, FL Steven Ory, MD IVF FLORIDA Reproductive Associates Margate, FL JK Williams, MD University of South Florida Tampa, FL R. Stan Williams, MD University of Florida Gainesville, FL Jerome Yankowitz, MD University of South Florida Tampa, FL

LEARNING OBJECTIVES TARGET AUDIENCE This program has been designed to meet the educational needs of physicians and nurses who have a specialized interest in the field of obstetrics and gynecology. LEARNING OBJECTIVES At the conclusion of this activity, the attendee should be able to: 

Discuss medical error reduction and prevention strategies;



Describe the standard management surgically of early and advanced ovarian cancer;



Critically analyze the prospective study co-pairing PDS vs. NACT;



Assess the clinical outcomes of patients receiving neoadjuvant chemotherapy for advanced stage ovarian cancer;



Discuss how and why to screen for intimate partner violence in a medical setting;



Describe the HPV vaccine recommendations for men;



Summarize the evidence concerning abortion and prematurity;



Develop a practice-specific care algorithm for prescribing progesterone;



Design an evidence-based infertility treatment plan for patients with PCOS;



Develop a plan to have in place to handle the pregnant patient who is non-responsive to standard management of acute severe hypertension;



Identify the age appropriate components of the well woman visit;



Access and apply new ASCCP guidelines for managing abnormal pap smears and cervical cancer precursors;



Implement an emotional intelligence (EI) focus into medical education;



Demonstrate practice and guidelines on how centering pregnancy can be incorporated;



Describe the impact of disease prevalence on predictive values;



Incorporate social media platforms for patient engagement;



Apply recent research findings on adolescent neuro development to strategies for promoting healthy behaviors among teens;



Discuss the global tobacco epidemic;



Discuss compliance requirements of HIPAA, as modified by the HIPAA/HITECH Omnibus Rule;



Review the possible civil monetary penalties for non-compliance, and reassess relationships with Business Associates;



Analyze the correlation between tobacco smoke and altered reproductive physiology.

ACCREDITATION ACCME ACCREDITATION The American College of Obstetricians and Gynecologists is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. AMA PRA Category 1 Credit(s)™ The American College of Obstetricians and Gynecologists designates this live activity for a maximum of 13.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. College Cognate Credit(s) The American College of Obstetricians and Gynecologists designates this live activity for a maximum of 13.25 Category 1 College Cognate Credits. The College has a reciprocity agreement with the AMA that allows AMA PRA Category 1 Credits™ to be equivalent to College Cognate Credits.

Nursing CE Credit provided by AKH Inc., Advancing Knowledge in Healthcare Nursing AKH Inc., Advancing Knowledge in Healthcare is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. This activity is awarded 13 Contact Hours. FL Nursing AKH Inc., Advancing Knowledge in Healthcare is an approved provider for nursing continuing education by the Florida Board of Nursing #50-2560. AKH Inc., Advancing Knowledge in Healthcare designates this educational activity for 13 contact hours (.13 CEU). Activity is co-provided by AKH Inc., Advancing Knowledge in Healthcare and the American College of Obstetricians and Gynecologists. The maximum allocation for participants attending the Domestic Violence course is 1 contact hour and the maximum allocation for participants attending the Prevention of Medical Errors course is 1 contact hour. CRITERIA FOR SUCCESS To claim credit for attending the meeting, please remember to sign-in at the registration desk each day of the meeting. Credits will be awarded based on the participant’s attendance. Attendees can complete the online meeting evaluation and claim credit at www.obgpathways.com until Friday, September 12, 2014. If you have further questions regarding the evaluation, please contact Allison Fellers at [email protected].

COMMERCIAL SUPPORT RECOGNITION This activity has been supported by unrestricted educational grants from Hologic Inc., Fujirebio Diagnostics and the University of Miami Area Health Education Center (UM AHEC).

FACULTY/PLANNING COMMITTEE DISCLOSURES DISCLOSURE OF UNLABELED USE AND INVESTIGATIONAL PRODUCT This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. DISCLAIMER This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc., Advancing Knowledge in Healthcare specifically disclaims responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant's misunderstanding of the content. AKH and ACOG planners and reviewers have no relevant financial relationships to disclose. DISCLOSURE OF FACULTY AND INDUSTRY RELATIONSHIPS In accordance with College policy, all faculty and planning committee members have signed a conflict of interest statement in which they have disclosed any financial interests or other relationships with industry relative to topics they will discuss at this program. At the beginning of the program, faculty members are required to disclose any such information to participants. Such disclosure allows you to evaluate better the objectivity of the information presented in lectures. Please report on your evaluation form any undisclosed conflict of interest you perceive. Faculty Janeen Alidina, MD Laurice Bou Nemer, MD Suzanne Bush, MD Dennis S. Chi, MD Julie Zemaitis DeCesare, MD John Diaz, MD Teresa A. Drake, JD Ricardo E. Estape, MD Jorge J. Garcia, MD David A. Grimes, MD William Hambsh, CPA, CPME, MACC Karen E. Harris, MD, MPH April Herbst, MD Melisa Holmes, MD Jay D. Iams, MD Jessica R. Jackson, MD R. Yates Knowlton, MD Richard S. Legro, MD Aldo M. Leiva, JD James N. Martin, Jr., MD James Mayer, MD Elissa Meites, MD, MPH Steven J. Ory, MD Christina Paidas-Teefey, MD Ashlyn H. Savage, MD, MSCR Caitliln Schultheis, MD Patrice M. Weiss, MD JK Williams, MD R. Stan Williams, MD Donald L. Wood, ARNP, CRNP, LHRM

Relationship N/A N/A N/A N/A Speakers Bureau N/A N/A Review Panel N/A Advisory Board N/A N/A N/A Part Owner N/A N/A N/A Consultant N/A N/A N/A N/A Medical Advisory Board N/A N/A N/A N/A N/A N/A Employed

Jerome Yankowitz, MD

Speakers Bureau (formerly)

Company Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose Bayer Nothing to Disclose Nothing to Disclose Intuitive Surgical Nothing to disclose Bayer Nothing to disclose Nothing to disclose Nothing to disclose Girlology, LLC, Guyology Nothing to disclose Nothing to disclose Nothing to disclose AstraZeneca and Euroscreen Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose Ferring Pharmaceuticals Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose The Doctors Company (Medical Malpractice Insurance Co.) Verinata

Friday, August 15, 2014

Patrice M. Weiss, MD    Patrice M. Weiss, MD is Professor and Chair of the Department of OB/GYN at the Carilion  Clinic/Virginia Tech Carilion School of Medicine.  She joined the Carilion Clinic OB/GYN in August  2007, with over a decade of clinical, administrative and medical education experience. She is the  immediate past chair of the ACOG Patient Safety & Quality Improvement Committee.  She is a  member of the ACGME OB/GYN Residency Review Committee and the Council of Residency  Education in OB/GYN.  She has served on the APGO Board of Directors and was an Ex‐Officio  member of the Professional Liability Committee and the Voluntary Review of Quality of Care  Steering Committee.    Dr. Weiss serves on the Carilion Medical Center Board of Directors as well as the Carilion Clinic  Board of Governors. She previously served as Medical Director of the Carilion Clinic Breast Care  Center, Vice Chair of Education, Research and Academic Compliance as well as Residency  Program Director and Clerkship Director at Lehigh Valley Hospital in Allentown, PA. She was also  the Medical Director of Risk Management for Lehigh Valley Physician Group.    Dr. Weiss received her medical degree from Hahnemann University (Drexel) School of Medicine  in Philadelphia, PA where she was inducted into the Alpha Omega Alpha honorary medical  society and completed her residency at Lehigh Valley Hospital.  She completed the Council of  University Chairs of Obstetrics and Gynecology Fellowship in Academic Leadership. She is a  Fellow of the American College of Obstetricians and Gynecologists and an Oral Board Examiner  with the American Board of Obstetrics and Gynecology.    She has published numerous peer‐reviewed articles and authored/co‐authored/edited  textbooks and textbook chapters. She lectures nationally on her passion: Medical Education,  Risk Management/Patient Safety/Medical Error and Communication/Emotional Intelligence.   Dr. Weiss resides in Roanoke, VA with her husband, Frank G. Finch, MD, and their two children,  Frank and Rachel.     





Patrice M. Weiss, MD Chair, Department of OB/GYN Carilion Clinic Professor – Virginia Tech Carilion School of Medicine

I have no relevant financial or other conflicts of interest pertinent to this presentation Uniquely qualified based on my SAT and MCAT scores

Emotional Intelligence

OBJECTIVES • • •

The rules for work are changing. We’re being judged by a new yardstick: not just by how smart we are, but by how we handle ourselves and each other.

List the elements of Emotional Intelligence Describe the importance of EI on professional success and leadership Implement an EI focus into your personal and professional life

Emotional Intelligence (EI) The capacity for recognizing our own feelings and those of others, for managing emotions well in ourselves and in our relationships, and for motivating ourselves and others.

Daniel Goleman, Ph.D. Psychologist, and noted expert on emotional intelligence



Self-Awareness



Self-Regulation



Motivation



Empathy



Social Skill

1

 Self-Regulation

 Self-Awareness

Definition The ability to recognize and understand your moods, emotions, and drives, as well as their effect on others Hallmarks Self-confidence Realistic self-assessment Self-deprecating sense of humor

Definition

The ability to control or redirect disruptive impulses and moods The propensity to suspend judgment – to think before acting Hallmarks

Trustworthiness and integrity Comfort with ambiguity Openness to change Harvard Business Law – Nov/Dec 1998

Harvard Business Law – Nov/Dec 1998

 Empathy

Definition The ability to understand the emotional makeup of other people Skill in treating people according to their emotional reactions

Hallmarks

Expertise in building and retaining talent Cross-cultural sensitivity Service to clients and customers

 Social

Skill

Definition Proficiency in managing relationships and building networks An ability to find common ground and build rapport

Hallmarks

Effectiveness in leading change Persuasiveness Expertise in building and leading teams

Harvard Business Law – Nov/Dec 1998

Harvard Business Law – Nov/Dec 1998

The Brain Made Ridiculously Simple  Emotions

Pre-frontal Cortex Amygdala

Human Mammalian

rule and act against your own will!  Unable to accurately read others’ emotions  Can’t find the right words…(stumbling, stuttering when you try to speak)  Unable to focus your thinking or actions  “Fight or Flight” kicks in…heart races, blood pressure increases, sweating profusely, uneasy feeling in the “gut”, clenched jaw, twitching, tapping foot, cold extremities as the brain rushes blood to muscles needed for fighting or fleeing…  Think

Thalamus

© 2007, Russell Consulting, Inc. – Helping Leaders Build and Sustain Great Organizations!

2

        

Conduct a “personal inventory.” Analyze the setting & identify skills needed. Enlist trusted friends. Focus on a few competencies. Practice, practice, practice. Be observant and reflective. Don’t expect immediate results. Learn from your mistakes. Acknowledge your successes.

3

  James N. Martin, Jr. MD    James N. Martin, Jr., MD is Professor of OBGYN, Director of the Division of Maternal‐Fetal  Medicine for the Winfred L. Wiser Hospital for Women & Infants, and Vice Chair for Research  and Academic Development at the University of Mississippi Hospitals and Clinics in Jackson.  He  holds a BS degree from Wake Forest University and an MD degree from the University of North  Carolina.  After OBGYN residency at Chapel Hill, NC and two fellowships, one in Stockholm,  Sweden for the World Health Organization in reproductive physiology and the other in Dallas for  maternal‐fetal medicine subspecialty education and training at Parkland Hospital, Dr. Martin  continues to be an active clinician, educator, administrator and investigator with a primary focus  of interest in hypertensive complications of pregnancy.  He has more than 600 scientific  publications and communications of various types to his credit over the past 30+ years.  He is  past president of the North American Society for the Study of Hypertension in Pregnancy 1997‐ 2000, the Society for Maternal‐Fetal Medicine 2000‐2001 and the American College and  Congress of OBGYN from 2010 to 2013.  Between 1989 and 2003 he was an examiner for the  American Board of OBGYN in general OBGYN and MFM.  He has been married for 44 years to Dr.  Gloria Howard Martin, a marriage and family therapist, and they are the parents of two adult  married children and four grandchildren.  Most recently Dr. Martin has been published in the  area of obstetric management of patients with hypertensive and hematologic disorders of  pregnancy, especially preeclampsia, eclampsia and HELLP syndrome.  In 2009 the Preeclampsia  Foundation presented its Hope Award to him for lifetime achievement in preeclampsia research.   He is a fellow of ACOG, the American Heart Association (AHA), the American Gynecological and  Obstetrical Society (AGOS) and an honorary fellow ad eundem of the Royal College of  Obstetricians and Gynaecologists.    In addition to his clinical and administrative duties, Dr. Martin oversees the graduate medical  program for its maternal‐fetal medicine fellows with 4‐6 fellows in training for a period of three  years each.  The MFM fellowship is structured around completion of a master’s degree in  science/maternal‐fetal medicine.  The OBGYN residency has a full complement of 24  postgraduates, a number of who at all times are assigned to the Obstetric/MFM Services.  The  graduating senior resident classes of 2006 and again in 2009 presented him with Excellence in  Mentoring Awards.  Dozens of clinical research projects are underway at this time which Dr.  Martin supervises.  In his spare time he enjoys reading, growing things, travel and the arts.  His  presidential initiatives for preeclampsia and global expansion of ACOG continue to impact the  specialty.           

HYPERTENSIVE CRISIS IN PREGNANCY MANAGEMENT DISTRICT XII ACOG ADM ORLANDO, FL 2014 James N. Martin, Jr. MD University of Mississippi Medical Center [email protected] NO CONFLICT OF INTEREST

OBJECTIVES 







Cover basic physiology and pharmacology relevant to clinical practice and preeclampsia Review the reasons for a focus on SYSTOLIC blood pressure control Discuss the ACOG practice guidelines relevant to this topic & practice Present four case examples, illustrating pitfalls in practice with preeclampsia

STAGE 3:MultiOrgan

STAGE 2

STAGE 1

PREECLAMPSIA PATHOPHYSIOLOGY

CNS

Emergent Therapy for Acute-Onset, Severe Hypertension with PE/E RE: ACOG Committee Opinion 514 December 2011 & New Guidelines

1

Severe Hypertension: Fundamental Concepts 



Avoidance & management of severe hypertension in patients with PRE/E is important to reduce risk and achieve successful, safe clinical outcomes Value of standardized, evidence-based clinical guidelines – UK Nice Guidelinesreduce maternal mortality related to CNS, Resp Comps

Definitions A-OSSH & A-OSDH: Acute-Onset Severe Hypertension with PRE/E     

A-OSSH  >160 mmHg x 15 mins A-OSDH  >110 mmHg x 15 mins Measured by standard techniques Considered a hypertensive emergency In the non-chronic hypertensive patient, it could be considered a “crisis”

Tuffnell et al, Outcomes of Severe Preeclampsia/Eclampsia in Yorkshire 1999/2003: Yorkshire Obstetric Critical Care Group. BJOG 2005;112:875-80

A-OSSH Important cause of CNS injury  UK Confidential Inquiries 20032008: 2/3rds of maternal deaths due to cerebral hemorrhage or infarction

A-OSSH 

– Series of 28 preg/pp patients w/ sPRE & stroke – All but one had A-OSSH – Only 13% had A-OSDH



Saving Mothers’ Lives: Reviewing Maternal Deaths to Make Motherhood Safer: 2006-08. The Eighth Report on Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG 2011;118:1-203

Mississippi Alert (Martin, 2005)



Confirmation in NonPregnant Adults The same association of A-OSSH with risk of hemorrhagic stroke is observed in nonpregnant adults (Lindenstrom, 1995)

Martin et al: Stroke and Severe Preeclampsia and Eclampsia: a Paradigm Shift Focusing of Systolic Blood Pressure. Obstet Gynecol 2005;105:246-54. Lindenstrom et al. Influence of Systolic and Diastolic Blood Pressure on Stroke Risk: a Prospective Observational Study. Am J Epidem 1995;142:1279-90.

SUBJECTS FOR STUDY 







1980-2003 UMMC = 31 stroke + pregnancy (before or during index pregnancy) 7/31 = antepartum/postpartum stroke in association with severe PRE/Eclampsia/No other attributable etiology 21 Forensic Sources Total=28 patients=Combined Study Group integrated for de-identification

SBP & DBP Changes Parameter

PregBaseline Pre-Stroke

Change

SBP-Mean

110.9+10.7

175.4+9.7

64.6+11.6

SBP-Range

90,136

159,198

39,85

SBP-%>160

0

96%

Only 3 patients received antihypertensives 110

0

12.5% (n=3)

DBP-%>105

0

20.8% (n=5)

2

Pulse Pressure & MAP Changes Parameter

PregBaseline

Pre-Stroke

Change

PP-Mean

43.6+6.7

77.4+13.8

33.8+14.1

PP-Range

30,57

57,102

13,59

MORTALITY 15/28 = 53.6%

All patients 50% increase above baseline, > 60 mm Hg prestroke MAP-Mean 81.7+7.7 123.9+6.6 42.1+8.2 MAP-Range

69,98

114,138

MAP-%>125

0

45.8%

MAP-%>130

0

20.8%

Among the 13 survivors, CNS deficits and disability persists in 10 of the 13……

25,57

25/28 = Permanent adverse sequelae

CREOG – ABOG Question 

What underlying pathology can the brain of a patient with PE/E exhibit? – PRES – Abnormal Cerebral Perfusion – Cerebral Vasospasm – Edema, Hyperemia, Focal Anemia, Thrombosis and Hemorrhage – Blindness 4hrs-8days

Arterial/Thrombotic

Unknown

What type of stroke is observed most commonly in the pregnant patient with preeclampsia+severe features/eclampsia? * Arterial/thrombotic * Venous/thrombotic * Arterial/hemorrhagic * Aneursymal * Unknown

CREOG –ABOG Question

TYPE of STROKE Arterial/Hemorrhagic

CREOG-ABOG Question



89.3% (N=25) 7.1% (N=2)

N=1

When is the most likely time for a stroke to occur in a patient with severe PRE/eclampsia? – Antepartum – Intrapartum – Immediate Postpartum (first 48 hours) – Delayed Postpartum (beyond 48 hours) – Immediate or Delayed Postpartum

3

ANTEPARTUM v POSTPARTUM: Timing of Stroke The majority of the strokes took place in the first five days ANTE POST postpartum;  Mean gestational age = 37.5 wks; range 21-41 wks 

60 50 40 30 20 10 0

N=12

N=16

Regarding Blood Pressure: BASIC CONCEPTS 

 

Blood Pressure Measurement = by itself it is an incomplete indicator of the status of the cardiovascular system (it is a measurement of large vessels, not the microcirculation) Blood Pressure = CO x SVR The Pathology of Preeclampsia  in the microcirculation, not the macrocirculation

21

ACOG Presidential Initiative 2011-2012: HYPERTENSION IN PREGNANCY Work Group

A-OSSH: Goals of Treatment  



Emergent Therapy for Acute, Severe Hypertension with Preeclampsia or Eclampsia (a first priority)



 Patient Management Order Sets ACOG Committee Opinion 514, December 2011Obstet Gynecol

NOT to normalize BP YES to achieve a range of 140-160/90100 mmHg Prevent repeated, prolonged exposure of the patient’s brain to SSH Prevent loss of cerebral vascular autoregulation Before delivery, transfer, induction of anesthesia

Lyons G. Saving Mothers’ Lives. Int J Obstet Anesth 2008;17:103-05.

4

A-OSSH: First Line Therapy 

IV Hydralazine – Patients may respond to one/other drug – Higher risk of maternal hypotension (160 mm Hg OR if DBP is >110 mm Hg 2. Institute fetal surveillance if undelivered 3. Give Hydralazine 5mg or 10mg IV over 2 min [DOSE 1] 4. Repeat BP in 20 min and Record 5. If either BP threshold is still exceeded, give Hydralazine 10 mg IV over 2 min  [DOSE 2] 6. Repeat BP in 20 min and Record 7. If either BP threshold is still exceeded, give Labetalol 20 mg IV over 2 min  [DOSE 3] 8. Repeat BP in 10 min and Record 9. If either BP threshold is still exceeded, give Labetalol 40 mg IV   over 2 min  and obtain emergency consultation from MFM, critical care or anesthesia 10. Give additional antihypertensive medication per specific order

11. Once these BP thresholds are achieved, repeat BP q10 min x 1h,  then q15 min  x 1h, then q30 min x 1h, then q1h x 4h. 12. Additional BP timing per specific order.

SEVERE INTRAPARTUM OR POSTPARTUM HYPERTENSION FIRST‐LINE MANAGEMENT WITH  LABETALOL INITIALLY

1.Notify MD if SBP is >160 mm Hg OR DBP is >110 mm Hg 2.Institute fetal surveillance if undelivered 3.Give Labetalol 20mg IV over 2 min [DOSE 1] 4.Repeat BP in 10 min and Record 5.If either BP threshold is still exceeded, administer Labetalol 40mg IV over 2 mins  [DOSE 2]. 6.Repeat BP in 10 min and Record 7.If either BP threshold is still exceeded, administer Labetalol 80mg IV over 2 min  [DOSE 3] 8.Repeat BP in 10 min and Record 9.If either BP threshold is still exceeded, administer Hydralazine 10mg   IV over 2  min 10.Repeat BP in 20 min and Record 11.If either BP threshold is still exceeded, obtain emergency consultation from  MFM/critical care/anesthesia/IM. 12.Give additional antihypertensive medications per specific order 13.Once these BP thresholds are achieved, repeat BP measurement q10min x 1h,  then q15min x 1h, then q30min x 1h, then q1h x 4h 14.Institute additional BP timing per specific order.

LABETALOL



  

Direct smooth muscle relaxation via increase cGMP in NO-rich/normal endotheliumarterioles>veinsdecr SVR Elicits a reflex stimulation of HR (baroreceptor reflex) and CO May increase plasma reninfluid retentionusually Rx’d with Bblocker and diuretic Bioavailability = 26-55% Half-Life = 2-4 hours Liver metabolismrenal excretion

LABETALOL 

      

Mixed alpha/beta adrenergic antagonist – Block Beta:Alpha 3:1 receptorsdecr SVR Oral 100mg bid1200mg bid IV 20mg over 2 minutes Half-Life (oral) = 6-8 hours (BioAvailability 25%) Half-Life (IV) = 5.5 hours IV Infusion = 2 mg/min up to 300 mg Hepatic pass metabolism to urine Relative Contraindications: patients with asthma, CHF, HB, bradycardia, cardiogenic shock

Systolic Blood Pressure 110 mm Hg in patient with PE/Eclampsia Persists = >1 reading (?length)



Antihypertensives for patients with CHTN are indicated if BP > 160/105 Treatment goal is BP sustained by treatment between 120/80-160/105

Common sense patients with acute severe hypertension have baselines usually 15 cig./day) SMOKING PROGENITORS: Mother:   Sperm count Father:  Genetic diseases

Biochemical and Genetic Alterations

IVF Parameters

Antioxidants concentration Reactive oxigen species Aneuploidy rate DNA damage

Cigarette Smoking During Pregnancy— United States, 1989-2004 25

20

20

Percent

TOBACCO and PREGNANCY

Sperm fertilizing capacity Ongoing pregnancy rate (>12w) Implantation rate

15 10.2

10 5 0 1989

1991

1993

1995

1997

1999

2000

2002

2003

2004

Note: Percentage excludes live births for mothers with unknown smoking status. Sources: National Center for Health Statistics 1992, 1994; Ventura et al. 1995, 1997, 1999, 2000; Martin et al. 2002, 2003.

15

SMOKING DURING PREGNANCY  Smoking is the most important modifiable risk  factor associated with adverse pregnancy  outcomes  23% of American women of  reproductive age  smoke cigarettes  Overall estimates of smoking rates during  pregnancy 10‐20%  In populations of  women with high prevalence of  smoking, it is estimated that cessation during  pregnancy could prevent: 10% of perinatal deaths 35% of low birth weight infants 15% of preterm deliveries

Pathophysiology  Carbon monoxide displaces oxygen and nicotine 

During pregnancy, nicotine  freely crosses the placenta  and has been found in  amniotic fluid and the  umbilical cord blood of  newborn infants. 

 

 

produces vasoconstriction‐ resulting in  impaired fetal oxygen delivery Smoking may also result in direct damage to fetal  genetic material Direct toxicity of the more 2500 substances found  in cigarettes, such as ammonia, aromatic  hydrocarbons, hydrogen cyanide, vinyl  chloride, and nitrogen oxide. Effect of over 4000 chemicals in mainstream tobacco  smoke Nicotine mediated sympathetic activation leads to  acceleration of fetal heart rate and a reduction in fetal  breathing movement‐

Source: American Cancer Society http://www.cancer.org/docroot/PED/content/PED_10_2x_Smokeless_Tobacco_and_Cancer.asp?sitearea=PED

Fetal Health Smoking during pregnancy causes:  Increased stillbirth and  neonatal deaths.  Premature birth  Lower birth weight  Increased chance of lung  development problems.   Increased chances of SIDS

SMOKING DURING PREGNANCY THE SINGLE MOST PREVENTABLE CAUSE OF ILLNESS AND DEATH IN MOTHERS AND INFANTS  Increases the risk of stillbirth by 40 to 60 percent.   Up to 8% of all babies who die less than a week after birth do so because of  problems caused by their mothers’ smoking during pregnancy.   Babies born to smokers are 1.5–3.5 times more likely to have low birth  weight and are at risk for serious health problems throughout their lives.   Up to ¼ of low birth weight births could be prevented by eliminating  smoking during pregnancy.   The risk for sudden infant death syndrome (SIDS) increases three‐fold for  mothers who smoke during and after pregnancy and two‐fold for mothers  who smoke only after delivery. 

* 2004 Surgeon General’s Report: The  Health Consequences of Smoking

95

16

Tobacco Use During Pregnancy Maternal Harm • Possible causal association

‐placenta previa ‐spontaneous abortion • Probable causal association ‐ectopic pregnancy ‐preterm PROM • Causal association ‐abruption placenta

Children’s Health Children of smokers:  Are more likely to become smokers  themselves.  Have more ear infections.  Are more likely to develop allergies  or asthma.  Have more bronchitis and  pneumonia.  May have decreased lung function. *cdc MMWR weekly, Dec.14, 2001/50(49): 1101‐6

Breastfeeding and Tobacco Minimal amounts of nicotine are excreted  into breast milk and absorption of nicotine  through the infant’s gut is minimal, but  tobacco smoking can have other effects on  breastfeeding that might indirectly affect the  baby

Environmental Tobacco Smoke (ETS)  6,200 children die annually in the US directly related to their 

parent’s smoking 2,800 from LBW complications 2,000 from SIDS 1,100 from Respiratory Infections 250 from Burns Asthma (smaller number)  56% higher chance of being hospitalized in the 1st year of life  The level of secondhand smoke a child is exposed       to at home or in a work environment is directly  proportional to the child becoming a smoker

99

Annual Smoking-Related Child Morbidity and Mortality

Maternal Smoking During Pregnancy Increases Risk of Offspring Behavior Problems  1‐2 day old infants ‐ elevated scores on measures of stress and 

excitability  Toddlers ‐ at increased risk for aggressive behavior, negativity 

and hyper activity  Teenagers ‐ at risk for memory problems and other cognitive 

difficulties  and an increase in risk for cigarette addiction during  adolescence.

17

Effects of Prenatal Tobacco Exposure Across Periods of Development

Prenatal secondhand smoke exposure  worsens ADHD, aggressive behaviors,  and poor school performance in these  children

SIDS SIDS

VERBAL/ LEARNING DEFICITS

INATTENTION ADHD

CRIMINAL OFFENSES

LOW BIRTHWEIGHT/ PREMATURITY

ATTENTION DEFICITS

CONDUCT DISORDER

ASPD

EXTERNALIZING BEHAVIORS

SMOKING UPTAKE

NICOTINE DEPENDENCE

STARTLES & TREMORS

Child Psychiatry and Human Development,  May 23, 2007

Infancy

Childhood

Adolescence

Adult

90% regret ever having started to smoke

The good news is… Most smokers Want to QUIT

89% plan to quit; only 3% don’t want  to quit 89% believe health will improve if quit 84% have tried to quit in the past 27% try to quit each year…

Percentage of Ever Smokers* Who Have Quit, Adults Aged > 18 Years, by Sex-United States, 1965 - 2004 60 51.4%

50

Percent

40

49.7%

Men

30 20

Women

10 1993 1995 1997 1999 2001 2003

1979 1981 1983 1985 1987 1989 1991

1965 1967 1969 1971 1973 1975 1977

0

Year Source: National Health Interview Surveys, 1965-2004; Centers for Disease Control and Prevention: National Center for Health Statistics and Office on Smoking and Health. *Ever-smoked >100 cigarettes, Also known as the quit ratio. Note: estimates since 1992 incorporate same-day smoking

Smoking Cessation if more cost‐ effective than other commonly  provided clinical preventive  services, including mammography,  colon cancer screening, PAP smears,  hypertension treatment and  treatment of high cholesterol

107

18

HEALTH BENEFITS OF QUITTING

Effective Interventions for Tobacco Cessation ● Provider intervention – 5A’s                                                ● Counseling (individual, group, quitlines) ● Pharmacotherapy  ● Reducing patient out‐of‐pocket costs (insurance  coverage) ● Increasing the unit price of tobacco products ● Smoking bans and restrictions ● Mass media campaigns  ● Reminder systems (for clinical settings)

Tobacco Training and Cessation Program Sources

PHS Clinical Practice Guidelines  Institutionalize a system to identify tobacco users 

at every visit.  Advise all who use tobacco to quit at every visit.  Use the 5 A’s or the 2 A’s and an R, or MI (Motivational 

Interviewing) approaches.  All stages of change should receive tobacco counseling.  Use effective Nicotine Replacement Therapy (NRT)     

CDC Best Practices Guidelines

Public Health Service Guidelines

Tobacco User Identification  For paper charts:  After the initial  question, the physician  could further initiate  intervention with: ASK

ADVISE REFER

VITAL SIGNS BP:

Pulse:

RR:

Temp:

Weight:

Height:

Tobacco Use: Current  Former   Never Form of Tobacco Used: How often: Did you advise patient to quit?

medications in assisting clients; very few                        contraindications exist.   Provide counseling, or refer to AHEC or the Florida  Quitline for local cessation resources.

Tobacco User Identification For Electronic Charts Encourage healthcare providers to implement a  provider reminder system  to automatically flag the  provider to ask about  patient’s tobacco status  and usage at each visit.

Referral:

19

Provider Reminder System Increases Intervention Rates Provider Reminder  System

Estimated rate of clinician  intervention (95% C.I.)

No provider reminder  system in place to  identify smoking status

38.5

Provider reminder  system in place to  identify smoking status

65.6 (58.3‐72.6)

Self-Help Materials • Appear to increase long-term abstinence ~1.5fold relative to no intervention1 • May be tailored to individual or type • Should be available in office and provided to all smokers

Source: 1Lancaster T, Stead LF. Cochrane Database Syst Rev. 2005(3):CD001118.

Source: 2008 CPG Treating Tobacco Use and Dependence Public Health Service

Modified Fagerström Test for Nicotine Dependence 1.

2.

How soon after you wake up do you smoke your first cigarette?

4. How many cigarettes do you smoke each day?

Within 5 minutes (3 points) 5 to 30 minutes (2 points) 31 to 60 minutes (1 point) After 60 minutes (0 points)

10 or fewer (0 points) 11 to 20 (1 point) 21 to 30 (2 points) 31 or more (3 points)

Do you find it difficult not to smoke in places where you shouldn't, such as in church or school, in a movie, at the library, on a bus, in court or in a hospital?

5. Do you smoke more during the first few hours after waking up than during the rest of the day? Yes (1 point) No (0 points)

Yes (1 point) No (0 points) 3.

Which cigarette would you most hate to give up; which cigarette do you treasure the most? The first one in the morning (1 point) Any other one (0 points)

6. Do you still smoke if you are so sick that you are in bed most of the day, or if you have a cold or the flu and have trouble breathing? Yes (1 point) No (0 points)

5 A’s of Tobacco Intervention

1) Ask if they smoke  At every visit  Chart the answer

2) Advise them to quit  Health care providers have a  great impact on their  patients 3) Assess their readiness  If ready, go to step 4  Or refer them to a specialist  Remain available  Those not ready to quit  should receive  motivational  interviewing (MI)

4) Assist them in quitting  Quit date  Quit plan  NRT or smoking cessation  drug  Behavioral therapy  Support groups 5) Arrange follow up   Call   Reassess  Reassure

Scoring: 7 to 10 points = highly dependent; 4 to 6 points = moderately dependent; less than 4 points = minimally dependent.

Health Care Provider Referral Rates Most health care providers ask about tobacco usage and advise against it, but up to only 23% make the arrangements to help their patients quit.

Health care providers 99.50%

Ask

94.90%

Advise

88.40%

Assess

63.70%

Assist Arrange

23.10%

2 A’s + R 3 MINUTE VERSION  ASK – every patient about tobacco use and  document in their medical record – 1 minute  ADVISE – urge every tobacco user to quit;  employ the teachable moment and link visit  findings with advice – 1 minute  REFER – patients to quitline or cessation  classes and document in medical record – 1  minute

From Elisa Tong, MD; Richard Strouse, BA; John Hall, JD, MS; Martha Kovac, MPH, and Steven Schroeder, MD. “National Survey of U.S. Health Professionals’  smoking prevalence, cessation practices, and beliefs” Nicotine and Tobacco Research Vol 12, N 7

20

Quitline  Call the toll‐free Florida Quitline at 1‐877‐U‐CAN‐ NOW (1‐877‐822‐6669) to speak with a trained and  certified Quit Coach® who will help you assess your  addiction and help you create a personalized quit plan.  You’ll receive proactive coaching sessions, self‐help  materials, and quit aids like nicotine replacement  therapy (NRT) (available while supplies last).  Ready to get started? Call the toll‐free Florida  Quitline 1‐877‐U‐CAN‐NOW (1‐877‐822‐6669)

AHEC Tobacco Cessation Services  Referral and Assessment   Education on Five (5) Core 

Essentials:  Dangers of smoking  Benefits of quitting  Challenges of quitting

 Quit Smoking Now   Six (6) class format  Tools to Quit   Two (2) hour seminar

 Aids for quitting  Support for quitting

 Free NRT (while supplies 

 Supportive Follow up

last)  Provided by trained  Tobacco Cessation  Specialists or Facilitators Treating Tobacco Use & Dependence: Get with the Guidelines

Mabel Castro, Tobacco Treatment  Specialist Call 305‐585‐5319 E‐mail: [email protected] Visit www.jacksonhealth.org/wellness‐ quitsmoking

Individual Counseling • Improves quit rates for adults1 • Recommended by US Public Health Service for adolescents • May be more effective than team-based counseling2 • When possible, should be >10 minutes, face-toface, with trained specialist3

Sources: 1U.S. Department of Health and Human Services. Reducing Tobacco Use. A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services; 2000; 2Gorin SS, Heck JE. Cancer Epidemiol Biomarkers Prev. 2004;13:2012-2022; 3Lancaster T, Stead LF. Cochrane Database Syst Rev. 2002(3):CD001292.

21

Motivational Interviewing

Pharmacotherapy

“A directive, client-centered counseling style for eliciting behavior change by helping clients explore and resolve ambivalence” The goal of using motivational interviewing is to help patients move through the stages of readiness for change in dealing with risky or unhealthy behavior.

Adapted from Prochaska JO, DiClemente CC. J Consult Clin Psychol 1983; 51: 390-5

Pharmacotherapy

Nicotine Replacement Therapy

Pharmacotherapy + behavioral counseling improves long-term quit rates

• Nicotine Patches  • Nicotine Gum • Nicotine Lozenge 

Smokers of 10 or more cigarettes a day who are ready to stop should be encouraged to use pharmacologial support as a cessation aid

• Nicotine Nasal Spray • Nicotine Inhaler

Aveyard P, West R. Managing smoking cessation. BMJ 2007;335;37-41

Nicotine Replacement

NRT: Nicotine patches

• Begin NRT on the quit date, (apply patches the night before)

• NRT provides levels of nicotine well below smoking • Prescribe in blocks of two weeks

Venous levels

20

Plasma nicotine concentration (ng/ml)

• Use a dose that controls the withdrawal symptoms

Cigarette (1-2mg nicotine)

15

10

5

Minutes

0

0

30

60

90

120

• Patches provide a slow, consistent release of nicotine throughout the day • Available in various shapes and sizes, • Common side effects with patches include skin sensitivity and irritation

• Arrange follow up to provide support

Nicotine patch (15mg nicotine)

NRT increases the odds of quitting about 1.5 to 2 fold Silagy C, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Systematic Reviews 2004

Plasma nicotine concentration (ng/ml)

20

• Use a full dose for 6 to 8 weeks then stop or reduce the dose gradually over 4 weeks.

15 10 5

Minutes

0

0

60

120

180

240

300

360

420

480

540

600

Adapted from : Henningfield JE. Nicotine medications for smoking cessation. N Engl J Med 1995;333:1196-203

22

Over-The-Counter (OTC) Nicotine Replacement Therapies Nicotine Patch 21 mg (or 14mg,  7mg) Dispense one month supply Replace patch daily

Prescription Medication  Buproprion HCl

or “Zyban”

Nicotine Gum 4 mg (or 2 mg) Dispense one month supply Chew up to 20 pieces a day as  needed

 Varenicline or 

“Chantix”

Nicotine Lozenges 4 mg (or 2 mg) Dispense one month supply Use up to 20 times a day as needed

Varenicline

Bupropion • Begin Bupropion a week before the quit date

• Begin Varenicline a week before the quit date, increasing dose gradually.

• Normal dose 150mg bid, (reduce in elderly, liver/renal disease)

• Alleviates withdrawal symptoms, reduces urge to smoke

• Contra-indicated in patients with epilepsy, anorexia nervosa, bulimia, bipolar disorder or severe liver disease.

• Common side effects include: nausea (30%), insomnia, (14%), abnormal dreams (13%), headache (13%), constipation (9%), gas (6%) and vomiting (5%).

• The most common side effects are insomnia (up to 30%), dry mouth (10-15%), headache (10%), nausea (10%), constipation (10%), and agitation (5-10%) • Interaction with antidepressants, antipsychotics and antiarrhythmics

Bupropion increases the odds of quitting about 2 fold Hughes J, et al. Antidepressants for smoking cessation. Cochrane Database Systematic Reviews 2007

Nortryptiline • Tri-cyclic antidepressant • Not licensed for smoking cessation • Low cost • Side-effects include sedation, dry mouth, lightheadedness, cardiac arrhythmia • Contra-indicated after recent myocardial infarction Nortryptiline increases the odds of quitting about 2 fold

• Contra-indicated in pregnancy • Severe changes in mood and behavior and serious adverse cardiovascular events have been reported

Varenicline increases the odds of quitting about 2.5 fold Cahill K, et al. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev 2007

Are there gender differences in tobacco smoking?  Women smoke fewer cigarettes per day  Tend to use cigarettes with lower nicotine content  Do not inhale as deeply as men  Women are less likely to initiate quitting and may be more 

likely to relapse if they do quit  Nicotine does not seem to reduce craving as  effectively for women 

as for men  Withdrawal syndrome may be more intense for women   More likely than men to gain weight upon quitting  Standard treatment regimens adjusted for gender differences 

 Root cause may be differences in nicotine sensitivity

Hughes J, et al. Antidepressants for smoking cessation. Cochrane Database Systematic Reviews 2007

23

Pregnancy • Smoking has adverse effects on unborn child • 20-30% of smoking women quit in pregnancy • Smoking cessation programmes are effective • NRT is assumed to be safe • Bupropion and varenicline are contraindicated

CODING REIMBURSEMENT

• Post-partum follow up reduces the 70% relapse rate

Pregnancy is often a trigger for quitting Lumley J, et al. Interventions for promoting smoking cessation during pregnancy. Cochrane Database Systematic Reviews 2000

 Tobacco use cessation counseling visit:  99406: 3‐10 minutes

$ 13.06 non‐facility; $ 12.25 – facility  99407: >10 minutes

$ 25.05 non‐facility; $ 23.84 ‐ facility  305.1: Tobacco Use Disorder  V15.82: History of Tobacco Use  Must provide other clinically relevant 

diagnosis code, such as cough 786.2

PRIVATE INSURANCE Florida does not mandate cessation  coverage for private insurance plans.   When plans do cover counseling, physicians can bill for it using the 

ICD‐9 code for tobacco dependence, 305.1 (tobacco abuse).  Include the appropriate CPT code for preventive medicine and  counseling and risk factor reduction interventions services codes         # 99401‐99404.  Not to be used for patients with symptoms of  established illness.   Prescription drug coverage varies according to plan.    Generally, insurance companies may reimburse at Medicare rates, if  not higher.

 8 visits in 12 months (4 per attempt)  Can use modifier – 25  Any eligible provider  Inpatient or outpatient  Document time spent counseling

TAKE HOME MESSAGE  Tobacco is an addiction with significant adverse  health consequences  Smoking during the reproductive years is  associated with significant risk to the mother,  the fetus, and her children  Effective behavioral and pharmacologic  interventions are available to achieve tobacco  cessation  We can implement cessation programs in our  daily clinical practices

Note: Reimbursement is dependent upon the patient’s plan and the  contract with the insurance company.

24

THANK YOU

25

Saturday, August 16, 2014

Jay D. Iams, MD  Jay D. Iams, MD, is a maternal fetal medicine specialist in Ohio State’s Department of Obstetrics and  Gynecology at The Ohio State University Wexner Medical Center.  After receiving his medical degree from the University of Wisconsin‐Madison, he completed a rotating  internship at the University of New Mexico, served in the U.S. Public Health Service and did one year of  pediatric residency in Phoenix before moving to Ohio State to train in obstetrics and gynecology and  maternal fetal medicine with Dr. Frederick P. Zuspan. Dr. Iams’ clinical and research interest is in  obstetrical aspects of prematurity; he directs the Medical Center’s Prematurity Clinic providing prenatal  care for women with increased risk of preterm birth. He has been the principal investigator (PI) at Ohio  State for the NICHD Maternal Fetal Medicine Network since 1992. He has published more than 150  original research articles, 60 reviews and editorials and 40 book chapters. Dr. Iams is an associate editor  of the American Journal of Obstetrics & Gynecology and an editor of the 5th, 6th & 7th editions of  Creasy & Resnik’s Maternal Fetal Medicine. He was president of the Society for Maternal Fetal Medicine  in 2003‐04, and served on the Maternal Fetal Medicine Division of the American Board of Obstetrics &  Gynecology from 2001‐07. He served on the National Academy of Science Institute of Medicine  Committee on Preterm Birth in 2005‐06 and is a member of the Prematurity Group in the Global Alliance  to Prevent Prematurity and Stillbirth (GAPPS). He is the OB Lead for the Ohio Perinatal Quality  Collaborative, a statewide project to reduce perinatal mortality and morbidity. Dr. Iams received  Lifetime Achievement Awards from the Society for Maternal Fetal Medicine in 2007 and from the  American College of Obstetricians and Gynecologists in 2011. 

Objectives Preterm Birth & Infant Mortality The Obstetrician’s Responsibility

At the close of this presentation, you  should want & be able to: 1. Accept Your Obstetrical Responsibility  to Reduce Infant Mortality. 2. Adopt 2 OB “Band‐Aids®” to Do # 1.

ACOG District XII  Annual District Meeting Jay D. Iams MD The Ohio State University Wexner Medical Center The Ohio Perinatal Quality Collaborative 



August 16, 2014

Hint: Adopt systems to ensure 2 Rx’s 

3. Embrace FPQC’s Projects in Your  Practice and in Your Hospital.

Dr. Iams has contracts via Ohio State University with: •NICHD for clinical research projects •OPQC for quality improvement projects •Elsevier for editorial & authorship roles in AJOG and Creasy & Resnik’s MFM textbook

The Ohio Perinatal Quality Collaborative   Obstetrics 39‐Week  Scheduled  Deliveries  without medical  indication 

Neonatal

ANCS for women  at risk for preterm  birth  (240/7 ‐ 33 6/7) Done  Transition to  BC Surveillance

2013‐2015 Increase Birth  Data  Accuracy &  Online  modules

Spread to all  maternity  hospitals in  Ohio

Prematurity is the Most Common Cause of Infant Mortality

BSI: 

34.3% of Infant Deaths Are Caused by Preterm Birth

High  reliability of  line  maintenance  bundle

Use of  human  milk in  infants  22‐ 29 weeks   GA 

Progesterone  for Preterm  Birth Risk

Neonatal  Abstinence  Syndrome

2010 Infant Mortality Rates

March of Dimes 2013 Report Card Premature Birth Rate 

1

Infant Mortality Rate in Florida Average in 2007‐2010

An infant death occurs within the first year of life. ** Suppressed due to missing data or insufficient numbers. Source: National Center for Health Statistics, final mortality data, 1990‐1994  and period linked birth/infant death data, 1995‐present.  Retrieved July 16, 2014, from www.marchofdimes.com/peristats.

Rates of  Contributing Factors

2012

2013

Uninsured Women Late Preterm Birth

29.3% 9.1%

29.7% 9.7%

X X

Women Who Smoke

18.6%

17.6%



Grade      

Care for Preterm Birth During Pregnancy 

The Medical Model of Care for Preterm Birth

1985 ‐ 2006

• Tertiary – After Parturition Starts

 Detection & Suppression of Contractions  Detection & Suppression of Infections  Detection & Replacement of Nutrients

o Improve Outcomes in Preterm Infants Steroids o No Effect on Incidence

• Secondary – Find & Reduce Risk

 Calcium, Omega‐3, Protein, Vitamins C + E  

o Before and During Pregnancy o In Individuals and Groups

• Primary ‐ Prevention of Risk o In Women, Before Pregnancy, Before Menarche o In Systems

 Detection & Surgical Rx of Short Cervix  Detection & Attention to Social Support  Progesterone    ???

Who Decreased the Preterm Birth Rate?

1996 ‐ 2012

• Obstetrician Gynecologists?  • Maternal Fetal Medicine Subspecialists? • Midwives and Family Physicians? 11.9% 11.7% 11.5%

• • • The Leadership Did It ‐ Not the Research Program !

They Publicized Available Data 2010

2011

2012

2

OPQC 39 Weeks Project in Sustain Phase   Decreasing Non‐Medically Indicated  Scheduled Deliveries Between 37 and 39 Weeks Gestation

ASRM Statements On Fertility Care And Twins, Triplets, & Higher Order Multiples

*

5% Goal

Data Is From All Ohio Maternity Hospitals 105 of 107 Hospitals Participated in the OPQC 39 Week Project

Report issued Nov 2011 by CDC – NCHS * 14

Obstetricians  Have The Band Aids

1996 ‐ 2012 • Ultrasound Dating • Fertility Rx • Sched PTB > 34 wk

•  Fertility Rx •  Sched Birth • Progesterone? 

• Antenatal Steroids o Review Documentation of ANCS Use o Systems Improvements in Birth Registry o Publish Rates of Documented Use 

11.9% 11.7% 11.5%

• Progesterone Supplementation

2010

2011

Birth Registry Documentation of ANCS Use  Aggregate Rate in 19 OPQC Sites 2006 ‐ 2014

o Women with a prior preterm birth o Women with short cervix                                in this pregnancy

2012

The Ohio OPQC Progesterone Project • Goal: Reduce Ohio PTB & Related Infant Mortality o Reduce Preterm Birth  40 centers in the US – Accrual goal: 800 patients

0% The other 10-20%

PRIMARY DEBULKING SURGERY vs. NEOADJUVANT CHEMOTHERAPY

PRIMARY DEBULKING SURGERY vs. NEOADJUVANT CHEMOTHERAPY

Conclusions

Conclusions

• With appropriate commitment primary optimal cytoreduction rates of over 70-75% can be achieved • A 70-75% primary optimal cytoreduction rate translates into a median OS for all patients (combined optimal and suboptimals) of ≥ 50 mos (MSKCC, du Bois, Maggioni, Park, and others) • PFS and OS with NACT is identical to primary suboptimal cytoreduction (OS ≈ 30-36 mos)

• Perhaps the decreased PFS and OS in the EORTC and CHORUS trials was due to the selection of pts with stage IV disease and/or THE MOST DIFFUSE stage III disease and/or medical comorbidities? • This further supports the argument that the results of the PDS vs. NACT trials should NOT be generalized to ALL pts with advanced ovarian cancer • Until there is further confirmatory data, NACT should be restricted to those most unlikely to undergo optimal primary surgery or those too medically compromised

5

Acknowledgements • • • • • • • • •

ACOG District XII John Diaz Rick Estape Robert Yelverton Karen Harris Guy Benrubi Colleen Filbert Allison Filbert Shelly Holmstrom

• • • • • • • • •

Richard Barakat Carol Brown Nadeem Abu-Rustum Yukio Sonoda Doug Levine Mario Leitao Ginger Gardner Elizabeth Jewell Oliver Zivanovic

THANK YOU!!!

6

Aldo M. Leiva, Esq.  Aldo M. Leiva, Esq. has practiced law for over 15 years and leads the Data Security and Privacy Practice  at Lubell Rosen, resident in Coral Gables, FL. Mr. Leiva represents and counsels diverse clients on  rapidly‐evolving federal, state, and international data security and privacy laws, including  HIPAA/HITECH, data breach notification laws, cyberliability, GLB, COPPA, CAN‐SPAM, FCRA/FACTA, and  EU/Latin American Data Protection law. In this capacity, he has also advised clients on the related fields  of Internet law, social media, digital media, mobile app and website marketing practices, and cloud  computing (both service providers and users).  In addition to his information technology focus, Mr. Leiva's broad complex litigation experience in state  and federal court in the areas of business/commercial litigation, electronic discovery law, tort defense,  real estate litigation, construction disputes, and professional liability provides added value and efficiency  to addressing clients' legal issues.  Mr. Leiva's interest in complex and technology matters is based on his professional and technical  background as a systems biologist (B.S., Binghamton, M.S., UMass Boston), having served as a scientific  researcher/instructor in Costa Rica, as well as a comparative legal investigator in Mexico.  In addition to his scientific and legal skills, Mr. Leiva has advocated for the Rule of Law in Cuba, serving  as counsel for Cuban political prisoners and pro‐democracy activists before the Inter‐American  Commission on Human Rights, resulting in a ruling against the Cuban government by an international  committee, for human rights violations. As a Cuba law/policy analyst, Mr. Leiva has also briefed the U.S.  State Department, U.S. Representatives/Senators, and U.S. Presidential candidates on Cuba law and  policy. He has also analyzed Cuba trends for trade and media organizations, and academic institutions,  including FAES, American University, University of Miami, Indiana University, and St. Thomas University.  Mr. Leiva is a member of the Florida Bar (Health Law Section), the American Bar Association (Health Law  Section), and the Cuban American Bar Association (Cuba Committee). He also participates in the Miami  Downtown Development Authority, Technology Advisory Council. Mr. Leiva also serves as Chairman of  the Board of the Amigos of the Cuban Heritage Collection at the University of Miami Library, the largest  collection of Cuban reference materials outside Cuba. 

Disclosure Aldo M. Leiva, Esq. Lubell Rosen, LLC Columbus Center 1 Alhambra Plaza Suite 1410 Coral Gables, Fl 33134 Phone: (305) 442 9211 Fax: (305) 442 -9047 Email: [email protected] m www.lubellrosen.com

HIPAA/HITECH and OB/GYNS: What you must know about

This speaker has no conflicts of interest to disclose relative to the contents of this presentation.

Patient Privacy and Data Security in 2014 Presented by

Aldo M. Leiva, Esq. Data Security and Privacy Attorney for American Congress of Obstetricians and Gynecologists August 15 -16, 2014

2014 Lubell Rosen, LLC

LEARNING OBJECTIVES At the end of this presentation, participants should be able to: Discuss the overall compliance requirements of HIPAA, as modified by the HIPAA/HITECH Omnibus Rule. Identify the possible civil monetary penalties for non -compliance, and reassess relationships with Business Associates. 2014 Lubell Rosen, LLC

WHY SHOULD YOU CARE? HIPAA enforcement has increased and is here to stay – Snowden Effect Not limited to large institutions - smaller groups Audit Programs Civil AND Criminal Penalties HIPAA violation as supporting evidence in patient’s privacy claim 2014 Lubell Rosen, LLC

2013 Lubell Rosen, LLC

DISCLAIMER These materials should not be considered legal advice and are not intended to nor do they create an attorney -client relationship The materials are general and may not apply to a particular individual legal or factual circumstances Information presented is based on educational needs of physicians and independent of commercial interests. 2014 Lubell Rosen, LLC

WHY SHOULD YOU CARE? As of February 2014: - Complaints filed= 92,975 - Cases investigated= 32,227 - Corrective Action= 22,222 - Civil Penalties= in excess of $ 16 million

2014 Lubell Rosen, LLC

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OB/GYN ISSUES Sensitive nature of PHI - social and emotional impacts of maternal history Pregnancies, Terminations, Sexual Assault, Rape, STDs, Mental Health Child Medical Information Unauthorized disclosure has enormous impact on patient

2014 Lubell Rosen, LLC

OVERVIEW OF PRESENTATION HIPAA Overview - How We Got Here HIPAA Omnibus Rule Key Provisions   

Business Associates Re -Defined Breach Notification New Penalty Structure

IN THE NEWS “Fury sparked as ob-gyn posts personal patient info on Facebook” NY Daily News, February 7, 2013 Physician “set off a firestorm by asking her online friends about a chronically late patient’s behavior - and sharing intimate details of a stillbirth”

2013 Lubell Rosen, LLC

POLICY GOALS OF HIPAA Modernize flow of patient health information Protect Privacy of health information

Compliance Activities and Considerations OCR Audit Overview – Past and Future Latest Enforcement Actions Insurance Considerations Questions and Answers

 2014 Lubell Rosen, LLC

Health Insurance Portability and Accountability Act “Covered Entities” - healthcare providers, plans, electronic health data clearinghouses “Business Associates” - contractors that receive, use, and process protected health information (PHI) Privacy Rule - governs PHI – includes paper! Security Rule - governs electronic PHI 2014 Lubell Rosen, LLC

2014 Lubell Rosen, LLC

HIPAA: KEY PROVISIONS Privacy Program - privacy officer, policies, and training Limits on Disclosure and Use of PHI Patient Rights Security Rule Safeguards – for ePHI Stronger State Law not preempted

2014 Lubell Rosen, LLC

2

HIPAA: A BRIEF HISTORY 1996 - HIPAA is passed into law 2003 - HIPAA Privacy Rule effective 2005 - HIPAA Security Rule effective 2008 - 33,000 Complaints, 8,000 investigated, 5,600 Corrective Actions NO FINES 2009 - Health Information Technology for Economic and Clinical Health Act Passed 2014 Lubell Rosen, LLC

HIPAA/HITECH OMNIBUS RULE Effective Date - March 26, 2013 Compliance Deadline - September 23, 2013 NO MORE PAPER(LESS) TIGER

 2014 Lubell Rosen, LLC

CE AND BA LIABILITY CE is liable for the violations of its business associates (BA) that are its agents BA is liable for the acts of its agents (i.e., Subcontractors)

 2014 Lubell Rosen, LLC

HIPAA: A BRIEF HISTORY (2) 2009 - 2012 Shift in Enforcement Strategy 2009 - CVS Caremark $ 2.25 Million Penalty 2010 - Cignet Health $ 4.35 Million Penalty 2012 - Alaska Dept. Health $ 1.75 Million 2012 - Phoenix Cardiac Surgery $ 100,000 January 2013 - Omnibus Final Rule published September 23, 2013 - Omnibus Final Rule Compliance Deadline 2013 Lubell Rosen, LLC

HITECH ACT - KEY PROVISIONS Compliance Requirements for Business Associates (BAs) Breach Notification Requirements New Penalty Levels Audits Extended Enforcement by State AGs

 2014 Lubell Rosen, LLC

BUSINESS ASSOCIATES RE -DEFINED BA is person/entity that “creates, receives, maintains or transmits protected health information on behalf of a covered entity”. New definition of BA includes records management companies that “maintain” records containing PHI, regardless of whether they are accessed or reviewed BA subject to the rule if it has access to electronic or hard copy PHI  2014 Lubell Rosen, LLC

3

BEFORE HITECH ACT BA was subject to breach of contract claim for violation of BAA 2009 - HITECH enacted - BA was now directly liable for PHI breach, but OCR agreed not to pursue enforcement actions against BA until finalization of the Rule Rule is finalized - enforcement actions can commence as of September 23, 2013  2014 Lubell Rosen, LLC

BA AGREEMENT TERMS (2) BAAs must also include a provision that allows the CE to terminate the underlying agreement if the BA violates a material term of the BAA Ensure that subcontractors receiving PHI from the BAA agree to the same restrictions on use and disclosure of PHI

 2014 Lubell Rosen, LLC

BA VIOLATIONS BA does not contractually impose restrictions on subcontractors Fails to notify CE of security breach within 60 days Fails to implement any of the administrative, physical, and technical safeguards in the HIPAA Security Rule Fails to follow “minimum necessary” standard  2014 Lubell Rosen, LLC

BA AGREEMENT TERMS Establish how BA is permitted or required to use and disclose PHI – must not use or further disclose PHI other than as permitted by or required by the BAA or by law Use appropriate safeguards to prevent PHI from being used or disclosed other than as permitted by the BAA Report to CE if it learns of any unauthorized use or disclosure of PHI  2014 Lubell Rosen, LLC

NO FORMAL BAA ? Omnibus Rule still applies BA must comply with the relevant HIPAA provisions irrespective of BAA terms or service contracts with customers

 2014 Lubell Rosen, LLC

COMPLIANCE ACTIVITIES Develop and implement Privacy Policies Conduct periodic Risk Assessments Develop and adopt Email Policies Develop and adopt Mobile Device Policies Train employees Designate Privacy/Security Officers Update Notice of Privacy Practices Revise BA Agreements Adopt Breach Assessment/Notification Policies  2014 Lubell Rosen, LLC

4

BREACH NOTIFICATION REQUIREMENTS (

Old Requirements under Interim Final Rule Breach is event that “compromises the security or privacy of the protected health information” and “poses a significant risk of financial, reputational, or other harm to the individual.”  2014 Lubell Rosen, LLC

FOUR FACTORS FOR RISK ASSESSMENT To whom the information was impermissibly disclosed Whether the information was actually accessed or viewed Potential ability of the recipient to identify the subjects of the data Whether recipient took appropriate mitigating action  2014 Lubell Rosen, LLC

TIER 1 - UNKNOWING CE or BA did not know and reasonably should not have known of the violation. $100 to $50,000 per violation Total of $1.5M for all violations of an identical requirement or prohibition occurring within the same calendar year  2014 Lubell Rosen, LLC

BREACH NOTIFICATION FINAL RULE (OMNIBUS) Any impermissible use or disclosure of protected health information is presumed to be a breach unless the regulated entity is able to demonstrate, through a risk assessment, that there is a low probability of compromise

 2014 Lubell Rosen, LLC

TIERED PENALTY STRUCTURE Significant increase in penalties Reduction in number of defenses Mandatory penalties for all violations due to “willful neglect” Applies to violations occuring after February 18, 2009

 2014 Lubell Rosen, LLC

TIER 2 - REASONABLE CAUSE CE or BA knew, or by exercising reasonable diligence would have known, that the act or omission was a violation, but the covered entity or business associate did not act with willful neglect $1,000 - $50,000 per violation Total of $1.5M for all violations of an identical requirement or prohibition occurring within the same calendar year

 2014 Lubell Rosen, LLC

5

TIER 3 - WILLFUL NEGLECT CORRECTED The violation was the result of conscious, intentional failure or reckless indifference to fulfill the obligation to comply with HIPAA. However, the covered entity or business associate corrected the violation within 30 days of discovery. $10,000 - $50,000 per violation Total of $1.5M for all violations of an identical requirement or prohibition occurring within the same calendar year

TIER 4 - WILLFUL NEGLECT UNCORRECTED The violation was the result of conscious, intentional failure or reckless indifference to fulfill the obligation to comply with HIPAA, and the covered entity or business associate did not correct the violation within 30 days of discovery. At least $50,000 per violation Total of $1.5M for all violations of an identical requirement or prohibition occurring within the same calendar year

 2014 Lubell Rosen, LLC

DEFENSE TO PENALTIES Penalty may not be imposed for violation that is not due to willful neglect and that is corrected within 30 days of actual or constructive knowledge of the violation, or during an additional period, as determined by the Secretary to be appropriate based on the nature and extent of the failure to comply

 2014 Lubell Rosen, LLC

PRACTICE TIP CE or BA that discovers a violation of HIPAA that is not due to willful neglect should attempt to: (i) correct the violation within 30 days of the discovery; (ii) document the date on which it discovered the violation(s); and (iii) document the date on which it implemented the correction in order to establish a basis for asserting the affirmative defense to the imposition of penalty for the violation.

 2014 Lubell Rosen, LLC

HHS DISCRETION HHS may waive a penalty for violations that are not due to willful neglect, in whole or in part, to the extent that the penalty is excessive relative to the violation. HHS has discretion to use other measures to address HIPAA violations, such as providing direct technical assistance or resolving possible noncompliance through informal means.  2014 Lubell Rosen, LLC

 2014 Lubell Rosen, LLC

AUDITS December 2012 - Pilot Audits Completed Evaluations of Pilot Program BAs to be audited as well

 2014 Lubell Rosen, LLC

6

OCR AUDIT PLANS FOR 2014 Streamlined audit process Expanded scope of Audits (to include BAs) OCR is hiring more auditors More audits are likely, with emphasis on BA

 2014 Lubell Rosen, LLC

PILOT AUDIT RESULTS (2) 80% of health care providers did not have a complete and accurate risk analysis Encryption - Organizations deciding against encryption did not document basis for doing so

 2014 Lubell Rosen, LLC

STATE AG ENFORCEMENT HITECH gave State Attorneys General authority to bring civil actions on behalf of state residents for violations of the HIPAA Privacy and Security Rules. State AGs may obtain damages on behalf of state residents or to enjoin further violations of the HIPAA Privacy and Security Rules.

 2014 Lubell Rosen, LLC

PILOT AUDIT RESULTS “Small” CE (< $50M in revenue) had more compliance issues (66% of deficiencies) Health care providers responsible for 81% of deficiencies Majority of deficiencies related to the Security Rule  2014 Lubell Rosen, LLC

AUDIT PROTOCOL Tool for Audit Preparation http://www.hhs.gov/ocr/privacy/hipaa/ enforcement/audit/protocol.html

 2014 Lubell Rosen, LLC

STATE AG PENALTIES Penalties are calculated by multiplying the number of violations by up to $100. Total penalties imposed for all violations of an identical requirement or prohibition during a calendar year may not exceed $25,000. The court, in its discretion, may award the costs of the action and reasonable attorney fees to the State.  2014 Lubell Rosen, LLC

7

ENFORCEMENT TRENDS As of June 30, 2013, OCR has investigated and resolved over 20,359 cases by requiring changes in privacy practices and other corrective actions by CEs. WellPoint pays $1.7M to settle potential violations (2013) Mass. Eye & Ear pays $1.5M to settle potential violations (2012)  2014 Lubell Rosen, LLC

ENFORCEMENT TRENDS (3) Barry University Data Breach – Dec. 31, 2013 CE reported data breach SEVEN MONTHS after laptop was infected with malware Violation of HITECH Rules - individual notifications must be provided without unreasonable delay and in no case later than 60 days following discovery of data breach  2014 Lubell Rosen, LLC

AUDIT TRENDS TO TRACK - 2014 OCR is requesting budget increase OCR will use $4.5 million in collected HIPAA penalties to help fund audit program OCR is seeking contractor for permanent audit program OCR Director Leon Rodriguez is slated to leave OCR for post at Homeland Security  2014 Lubell Rosen, LLC

ENFORCEMENT TRENDS (2) December 24, 2013 - OCR imposed $ 150,000 penalty and corrective action plan CE reported stolen UNENCRYPTED thumb drive with PHI to OCR and notified patients within 30 days OCR issued penalty due to failure of CE to: - conduct adequate risk assessment of ePHI - adopt written policies and train personnel - reasonably safeguard unencrypted thumb drive  2014 Lubell Rosen, LLC

AUDIT TRENDS TO TRACK - 2014 Much larger pool of entities subject to enforcement Likely that enforcement actions will increase BA focusing on record storage and document destruction may be subject to more scrutiny due to large volume of PHI potentially at risk OCR is hiring more auditors More audits are likely, with emphasis on BA  2014 Lubell Rosen, LLC

CYBERLIABILITY COVERAGE Review existing insurance policies Traditional D & O and E & O Policies may provide HIPAA coverage, unless excluded Consider additional coverage HIPAA Policies - investigations, defense costs, and penalties Consult with Insurance coverage counsel

 2014 Lubell Rosen, LLC

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THANK YOU Aldo M. Leiva, Esq. Chair, Data Security and Privacy Practice Lubell Rosen One Alhambra Plaza, Suite 1410 Coral Gables, FL 33134 [email protected] www.lubellrosen.com Direct: (305) 442 -9211

 2014 Lubell Rosen, LLC

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Richard S. Legro, MD    Dr. Richard S. Legro received his medical degree from the Mount Sinai School of Medicine in New York,  NY, completed his residency in Obstetrics and Gynecology at Magee Women’s Hospital at the University  of Pittsburgh in Pittsburgh, PA and a fellowship in Reproductive Endocrinology and Infertility at the  University of Southern California in Los Angeles, CA.  He is a Professor in the Department of Obstetrics  and Gynecology and Public Health Sciences at Penn State University College of Medicine in Hershey, PA.  His research and clinical practice are primarily focused on polycystic ovary syndrome (PCOS)‐ diagnosis,  treatment, and genetic/environmental causes as well as on improving infertility diagnosis and  treatment.  He established at the Milton S. Hershey Medical Center one of the first clinics devoted to the  treatment of women with PCOS.     Dr. Legro has been the principal investigator on a number of National Institutes of Health (NIH) grants  including the NIH Reproductive Medicine Network since 2000 where he has been the lead investigator  of the Pregnancy in Polycystic Ovary Syndrome I and II trials. He has also served as a chair of the Steering  Committees of several ongoing multi‐center infertility trials in China including infertility trials of  Traditional Chinese Medicine (TCM) and in‐vitro fertilization (IVF).  Dr. Legro has published over 200  peer ‐reviewed articles in medical journals and multiple books in the field of reproductive endocrinology.   He has served as a member and chair of multiple NIH study sections.  Dr. Legro is an Associate Editor for  the journals Seminars in Reproductive Medicine and Fertility and Sterility, and is on the editorial boards  of Endocrine Reviews and Endocrinology.  He is a subspecialty board examiner for the American Board of  Obstetrics and Gynecology, a member of the Finance Committee of the Endocrine Society and of the  Board of Directors of the American Society for Reproductive Medicine.  

.

Polycystic Ovary Syndrome: Back to the Stein Leventhal Age

Conflicts NIH funding NIH consultant Consultant: Euroscreen, AstraZeneca, Ferring

Off Label Uses Richard S. Legro, M.D., Penn State College of Medicine, Dept of Ob/Gyn, Hershey, PA, USA

Learning Objectives Define the key pathophysiologic mechanisms of anovulatory infertility in PCOS Identify an evidence-based strategy for treating infertility in PCOS Counsel patients about the risks of treatment and ensuing pregnancies that result from treatment

Stein-Leventhal Syndrome Both were Ob/Gyns who practiced at Michael Reese Hospital in Chicago

Metformin, Other Anti-Diabetic drugs, and Aromatase Inhibitors are not FDA approved to treat infertility and/or PCOS

Polycystic Ovary Syndrome: Chronic Anovulation with Androgen Excess

Stein‐Leventhal Syndrome (Am J Obstet Gynecol 1935;24:181‐91)

Original description of disorder in 7 women Amenorrhea (usually secondary) or occasional  menometrorrhagia Hirsutism Sterility Large, pale polycystic ovaries with thickened capsules

“Adequate” wedge resection of ovaries resulted  in regular menstrual periods and fertility in “all” cases

1

Long-Term Improvement in Androgen Levels After Ovarian Diathermy in PCOS

Wedge Resection of a Polycystic Ovary (through a  laparotomy!):  Patients were well selected. In a 20‐year  period Stein/Leventhal performed only 96 procedures  (63/71 women desiring fertility conceived).

Adi and Tank, J Obstet Gynecol India 2010 Gjonnaess H. Fertil Steril 69: 697-701, 1998

Increasing Utilization of IVF for Ovulatory Dysfunction: More Multiple Pregnancies PCOS is the most common cause of anovulatory infertility (80%) In 2011 26% of ART pregnancies are twins and 1.3% are high order multiples

How to treat Infertility in PCOS?

Clomiphene, GnRH, Aromatase Inhibitor

CDC Assisted Reproductive Technology National Summary Using own Eggs Number of IVF cycles Ovulatory Dysfunction (%)

2005

2011

89,385 101,213 8%

14%

SHBG Insulin Sensitizing Agents, GLP-1 Analogues, Weight loss, Exercise

FSH, Ovarian Surgery

Elevated Androgen and Estrogen  Levels in PCOS vs normal women  (cycle day 2‐4)

Increased  Pulsatile pattern  of LH & not FSH  (Rebar et al., J  Clin Invest  1976;57:1320) Thanks Bob for sharing these slides!!! DeVane et al., Am J Obstet Gynecol 1975;121:496

2

Marked Hyperinsulinemia with Glucose Challenge

Polycystic Ovary Syndrome: Chronic Anovulation with Androgen Excess

Chang J et al, JCEM 1983

Hyperandrogenism and Hyperinsulinism in PCOS

Insulin Sensitivity in PCOS by Euglycemic Clamp

Dunaif et al, Diabetes, 1989

PCOS-Health Risks Type 2 Diabetes

Endometrial Cancer

Prevalence of Glucose Intolerance in PCOS 90

Uncertain Cardiovascular disease Ovarian/Breast Cancer

Study Site

100 80

Percent

Accepted

Nestler, NEJM, 2008

University of Chicago**

122

Penn State Univ*

144

Mt Sinai*

110 408

70

Rezulin Collab

60

TOTAL

Grp¥

784

50 40 30 20 10 0

Normal

IGT

Type 2 DM

**Ehrmann et al Diabetes Care 1999, *Legro et al JCEM 1999 ¥Azziz et al JCEM 2001, Ehrmann et al, JCEM, 2005

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Coronary Heart Disease Risk Factors are Increased in PCOS

Increased Carotid Intimal Medial Thickness (Surrogate CVD Outcome) in PCOS

206 women with PCOS (chronic anovulation and hirsutism or elevated total testosterone or LH/FSH ratio > 2) and 206 controls from voter records

Abnormal Plaque Index in 7.2% of women with PCOS vs 0.7% of controls

PCOS women with significantly increased risk factors increased BMI and WHR increased insulin increased triglycerides and cholesterol, decreased HDL

After controlling for confounding variables lipid differences were still significantly different between PCOS and controls Talbot et al, Arterioscler, Thromb, Vasc Biol, 1996

Talbott EO et al, Arterio,Thromb, Vasc Bio, 2000

Effect of Age on LDL-C: Worse in Controls

But, where are the CVD events and where is the increased premature mortality? Talbott EO et al, J Clin Epidemiol, 1998

No Change in CVD Risk Factors over 10 years in Women with and without PCOS in SWAN Cohort

Lack of Increased CVD Hazard Ratio According to PCOS Phenotypes (compared to normal controls) in SWAN Cohort Polotsky et al, JCEM, 2014

N= 1166 women

Polotsky et al, JCEM, 2014

Metabolic syndrome Stroke Myocardial Infarction

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What is the evidence that treating insulin resistance treats symptoms of PCOS? Summary Recommendation: Need long term epidemiologic studies to determine CVD and Cancer Risks

Diazoxide Lowers Androgens and Increases SHBG

Diazoxide Suppresses Insulin in Women with PCOS (N =5)

Nestler et al, JCEM, 1989

Nestler et al, JCEM, 1989

Impractical to Use Diaxoide in PCOS Fluid retention Weight gain Increased glucose levels Increased body hair Everywhere on the body (i.e. not androgen dependent)

Drug Treatments for Type 2 Diabetes Used in PCOS Insulin Resistance Thiazolidinediones (d-chiro-inositol) cell Dysfunction GLP-1 Analogues (exenatide, liraglutide)

Increased Hepatic Glucose Production metformin Glucose Absorption- Acarbose

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Ovulation with D-chiro-inositol in PCOS INS-1

90 80

Placebo

70 60 50 40 30 20 10 0 % Ovulation

Nestler et al, NEJM, 1999

D-Chiro-Inositol: Neither Gone nor Forgotten

Incidence Rate of Ovulation with Troglitazone Number of (observed/expected) ovulations averaged for each treatment group 0.8

Based on Pdg Peak > 5 days

Adjusted Mean Rate

P = 0.0001

0.6

0.62* P = 0.02

0.4

0.4

0.47*

0.32 0.2

0 PBO

T 150

T 300

T 600

Azziz et al, JCEM, 2001

Thiazolidinediones in PCOSUnfavorable risk/benefit ratio TroglitazoneRemoved from the market due to hepatoxicity

RosiglitazoneConcerns about increased risk of myocardial infarction ADA recommends against its use except for refractory type 2 DM

Pioglitazone Bladder Cancer

Class Effects Pregnancy Category C – ? Fetal toxicity

Weight gain Increased adiposity

Metformin - Favorable Pharmacology Circulates unbound Excreted unchanged from the kidney Avoid with renal impairment

Short Half-life of 1.3-4.5 hours. Rarely induces hypoglycemia Relatively safe and well tolerated 20% GI side effects- Nausea/diarrhea Weight neutral or weight loss Pregnancy FDA Category B

6

Most Cited Study: PCOS and Metformin Open label study of metformin in 26 women with PCOS Metformin improved BMI, waist to hip ratio (WHR) AUC Insulin and Glucose OGTT, adjusted systolic blood pressure, apo A-1, SHBG, LH, FSH total testosterone, free testosterone , androstenedione, dehydroepiandrosterone sulfate, free androgen index, ABSTRACT TRUNCATED AT 250 WORDS Most Frequently Cited Article of PCOS and Metformin: Cited 472 times as of April 29, 2014- ISI Web of Science

Patients with PCOS Want Good Clinical Outcomes!

Metformin/Clomiphene and Ovulation (N = 61)

Ovulation

Live Birth Improvement in Hirsutism

Circulating Androgens

Diabetes Prevention

Circulating Gonadotropins

Endometrial Cancer Prevention

Insulin Resistance

Cardiovascular Disease Prevention?

Ovulation Rate

34%

90% 4%

8% Clomiphene 50 mg/d or placebo

Metformin or Placebo

Weight/ Body Fat Distribution Legro RS for the RMN, Hum Reprod, 2004

Day: 0

14

28

35

39

44

53

Nestler JE et al, NEJM, 1998

Pregnancy Rate/Ovulation: Increased Efficiency of Metformin vs Clomiphene Over Time 45 40

Metformin CC

35 30 25 20 15 10 5 0 1

2

3

4

5 6 Palomba et al, JCEM, 2006

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Complications of PCOS Pregnancy Placebo Metformin N = 18 N = 22 3 3 Gestational DM, Pre- Gestational DM, eclampsia Pre-eclampsia 6 0 Preterm Delivery 2 0 ARDS and Pulmonary Embolus

Minor Pregnancy Major Pregnancy Major Post Partum

If something is too good to be true expect replication!

Vanky et al, Hum Reprod, 2004

PCOS couples without other infertility factors

Clomiphene Citrate/Placebo (N = 209)

Metformin XR/Placebo (N = 208)

Outcomes

Metformin/ Clomiphene Citrate (n = 209)

Primary efficacy parameter: Live birth rate

Secondary efficacy parameters: Singleton live birth rate, abortion rate, and ovulation rate.

Live Birth Legro et al, NEJM, 2007

Clomiphene Superior to Metformin for Live Birth: PPCOS I

Does Ovulation = Live Birth ?

0.5

P-value: $5 in medical costs 

RCOG, ACOG AND SOGC • • • • •

Global collaboration Meeting in Washington, DC in Fall 2013 Coordinate efforts, share information Collaborate not duplicate Maintain “cost neutrality” for ACOG

Let’s Look at the United States • About 4 million births annually • Maternal mortality has increased: – From 1990 to 2008 ratio of deaths per 100,000  increased from 13 to 17 – We are 40th when compared to developed  countries Hogan et al 2010. Maternal mortality for 181 countries, 1980‐2008: a systematic analysis of towards  Millenium Development Goal 5.375:1609‐23

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What is happening with maternal  mortality? • • • • • • • •

Change in data collection Access to prenatal care Obesity Chronic medical conditions like diabetes and  hypertension Cardiovascular disease Repeat cesarean sections Lack of preconception care Lack of contraception use/counseling

The Subgroups • • • • •

Improved Surveillance and Research Quality and Safety in our Clinical Care: ACOG Awareness to Action State AND Community Health Systems Well Woman Health Care:  ACOG

National Maternal Health Initiative

Collaborative Effort with an alignment of health care  organizations invested in women’s health, reproductive  health strategies and maternal care

Quality and Safety in Clinical Care • Standardized maternal death reporting process • Regionalization of Care • Birth Center Self‐Assessment  Protocols and Algorithms for Maternal Conditions • Measured blood loss • Response to Vital Signs • Eliminate elective inductions

Well Woman Health Care

TASK FORCE ON THE WELL WOMAN VISIT What elements should be part of every well  woman visit?

• Women have Reproductive Life Plans, with  contraceptive choice a key concept • Women maintain a healthy weight and physical  activity  • Women with Chronic Medical Conditions enter  pregnancy in a optimal health • Reevaluate the post‐partum visit 

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Advocacy : Contraceptive Access Committee Opinion #544: OTC Access to Oral Contraceptives  Dec. 2012 • Weighing the potential risks versus the benefits and based on  currently available data, oral contraceptive pills should be  available over‐the‐counter without a prescription. • Access to and cost issues are common reasons why women do  not use contraception or use it inconsistently. OTC OC availability  may improve contraceptive access and usage and may decrease  unintended pregnancy rates. • Women can self‐screen for most contraindications to OCs using  checklists. • Continuation rates of oral contraceptives are higher in women  who have access over‐the‐counter or are provided with more pill  packs.

Dr. Malcolm Potts, Chair of Population and Family Planning  at UC Berkeley’s School of Public Health

LARC Summary 

• Practice Bulletin #121, Long‐Acting Reversible Contraception: Implants and  Intrauterine Devices • Committee Opinion 539, Adolescents and Long‐Acting Reversible  Contraception: Implants and Intrauterine Devices • Encouraged as first‐line options  • Can be used by most women • Highly effective, few contraindications • Highest continuation and satisfaction rates  • Can reduce unintended pregnancy  • Clinicians should provide anticipatory guidance to patients regarding  bleeding patterns  •

• “Family Planning is a natural and essential part of modern  living.” • “Family Planning has allowed societies to become more  sustainable and more prosperous, and the world has  become a more peaceful place.” • “If you’re working in cancer or orthopedics or pediatrics,  you make people more healthy by trying to relieve pain  and suffering. What we’ve done in gynecology is  change civilization.” •

“ENVIRONMENT” Includes:

REPRODUCTIVE HEALTH AND THE ENVIRONMENT

• Industrial chemicals • Agricultural chemicals • Physical agents  (heat, radiation) • By‐products of  combustion and  industrial processes  (dioxin)

• Foods and nutrients • Prescription drugs • Lifestyle choices and  substance abuse • Social and  economic factors

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Why Do We Not Address  Environmental Issues?

Should We Be Concerned? 

Medical Providers do not discuss Environmental Impacts on Health because A.  The research is lacking B.  We are not comfortable with the topic C.  There are no data to support the topic historically D.  We have more important topics to discuss E.  We follow the ostrich approach: we hide our heads unless we can give a full and complete answer, or solve the problem F.   We really are unaware that there is a problem G.  We do, we just have not realized it (blood sugar/hypertension)

Dr Birnbaum:NIEHS, Sharpe and Irvine, 2004

Chemicals in the Environment • 84,000 chemicals listed by the  EPA • 700 new chemicals released  annually • 3000 chemicals are “high  volume” or exceed 1million  pounds of use a year • The vast majority have not had  research or been subjected to  standard studies U.S. Environmental Protection Agency. TSCA Chemical Substance Inventory. 2012 Available from: http://www.epa.gov/oppt/existingchemicals/pubs/tscainventory/basic.html. Vogel, S.A. and J.A. Roberts, Why The Toxic Substances Control Act Needs An Overhaul, And How To Strengthen Oversight Of Chemicals In The Interim. Health affairs, 2011. 30(5): p. 898-905.

How Can We Lead? • ACOG voice in collaboration with Reproductive Health  and the Environment • Support state and national legislation on environmental  health • Create educational opportunities – ACM – ADM – ABOG – CREOG – ARHP

Neonatal Encephalopathy • Dr Waldman recommendation to revisit the topic  with all the new research • Publication Spring 2014 • Impressive international collaboration between  OBGYNs, neonatalogists, neurologists and  radiologists  • Critical role in imaging studies and NICU response

2014 National Residency Match • • • • • • • •

17,374 graduates from Allopathic  Med Schools 2738 graduates from Osteopathic Med Schools 20,012  total graduates of US Medical Schools 28,490 US applicants to either 1st or 2nd year 16,399 US graduates matched 18,275 1st or 2nd year positions were matced  4.8% of US seniors were unmatched 2541 graduates with no position through Resident Match

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Ob/Gyn 2014 Resident Match • 233 Ob/Gyn Residency Programs • 1242 positions in offered • 950 US graduates filled positions • 1073 US gradates applied • 123 US med students left wanting Ob/Gyn Obstetrics and Gynecology represented 4.7% of total  resident match positions in 2014 as compared to 5.2% in  2010

ACOG TASK FORCE ON LEADERSHIP

Leadership in ACOG People are our most important  assets!! We must value the differences and strengths of individuals  within an organization

Leadership Opportunities

• Importance of diversity in the organization • Importance of demographic data collection on all of  our leaders…“you don’t know what you don’t know”! • How can we encourage leaders such as you to be  involved in ACOG • Leadership is a Jungle Gym: up down sideways and  all around

ACOG Task Force on Collaborative  Practice

 Congressional Leadership Conference    

     

2.5 day event in Washington, DC MARCH 2‐4, 2014 Top level speakers, JF specific courses, 21 CMEs 2013 CLC: 340 Fellows & JFs to Congress,>300meetings Sponsored by Districts or Sections

McCain Fellow Gellhaus Resident Advocacy Program 46 ACOG Committees with >500 MEMBERS Section and District Leadership and Committees Quality &  Safety for Leaders in Women’s Healthcare National Leadership Institute 3.5 days each April

• Revise the 1995 ACOG document on Collaborative  Practice • Promote collaborative practice models • Develop educational tools for women’s health care  team leadership • Create multi‐disciplinary education models for  women’s health care

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What Do We Do?

ACOG POLITICAL ACTION COMMITTEE  and Government Relations:  THE PAC

 Win legislative battles  Develop relationships with ACOG Fellows and  Members of Congress  Work to elect the right candidates in the US Congress  and statehouses  Lobby Congress  Elect our own  Candidate Workshop

State Legislative Advocacy  Awards Program

State Legislative Support OO

MESSAGES

ACOG MESSAGING AND BRANDING

• • • • • •

Legislators OUT of our exam rooms How do we brand ourselves? How do we message effectively? How does our message become CONTAGIOUS? Placing quality and safety first Physician leaders

8

MISSION ACCOMPLISHMENT BEGINS  WITH EFFECTIVE COMMUNICATION • • • • • •

From National Leadership To District and Section Leadership From Leadership  To individual Fellows From individual Fellows To Patients, Practices, Hospitals, and communities

Just a few of ACOG Challenges Defining the OB/Gyn of the future Ob/Gyn training to meet workforce needs Access to quality women’s health care Preserving the physician/patient relationship Positively affecting ACA implementation Developing collaborative practice models Supporting research in women’s health Maintain relevance with employed Ob/Gyns Confronting medical liability issues

• • • • • • • • •

Challenges to Ob/Gyn Practice • Adapting to a changing marketplace • Reconciling the evolution from fee for service to  quality/value system • Addressing rising costs • Emphasis on patient centered care • Intense and increasing competition • Alignment of women’s health care delivery  and  ACOG mission

Leadership Must Maintain Credibility • • • •

With members in all ACOG categories With women we serve With professional organization partners With media

Download the ACOG app for iPhone and iPad

9

The Future of ACOG  is EXACTLY WHAT  WE MAKE OF IT You cannot create the future while clinging to the past

10

ACOG District XII Annual Business Meeting Saturday, August 16, 2014 The Ritz-Carlton Orlando, Grande Lakes | Orlando, FL 12:30‒1:00 PM Agenda

1. Welcome/Call to Order

Robert W. Yelverton, MD

2. Secretary’s Report  Approval of 8-17-13 Minutes

Shelly Holmstrom, MD

3. Chair’s Report

Robert W. Yelverton, MD

4. Vice Chair’s Report

Karen Harris, MD

5. Treasurer’s Report

Guy Benrubi, MD

6. District XII Elections  Sections 3&6

Shelly Holmstrom, MD

7. Past Chair’s Report  District Elections

Alfred Moffett, MD

8. Liaison to the Junior Fellows Report

Cole Greves, MD

9. New Business 10. Adjourn

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47

ACOG District XII-Florida Annual Business Meeting Minutes Saturday, August 17, 2013 11:50 AM-12:10 PM The Breakers | Palm Beach, FL

WELCOME/CALL TO ORDER

Chair, Robert Yelverton, MD called the ACOG District XII Annual Business Meeting to order at 11:50 AM.

UPDATE ON DISTRICT XII ACTIVITIES

Robert Yelverton, MD welcomed everyone for their attendance and support at the inaugural Annual District Meeting. He reported that it has been a busy but good year. Much of the time has been spent on getting acclimated to being a new District as well as developing the Advisory Council and Committees. He thanked everyone for hard work during the transition with the ACOG Florida Section to ACOG District XII.

TREASURER’S REPORT

Guy Benrubi, MD gave a brief update on the financial status of the new District XII. He stated that the District is off to a great start because of the funding transferred from ACOG District IVFlorida Section, the Florida Obstetric and Gynecologic Society (FOGS) investment funds that had been transferred as well as the income received from the first year dues for District XII.

SECRETARY’S REPORT

Shelly Holmstrom, MD provided the membership an update on the District XII, Section 2 and 5 elections. She reported that nominating committees had been established and announced candidates for each Section: Section 2 Chair-Richard A. McCauley, MD Vice Chair-Meridith J. Farrow, MD Section 5 Chair-Maureen Whelihan, MD Vice Chair-Linda Kiley, MD

ADJOURNMENT

With no further business to discuss, the meeting was adjourned by the Dr. Yelverton at 12:10 PM.

Sunday, August 17, 2014

  Teresa Drake, JD     Teresa Drake is co‐founder and Director of the Intimate Partner Violence Assistance Clinic (IPVAC) at the  University of Florida Levin College of Law.   This first‐of‐its‐kind domestic violence clinic is collaboration  between the U.F.’s College of Law, College of Medicine, Shands Teaching Hospital and the local non‐ profit Peaceful Paths Domestic Abuse Network.  The multidisciplinary IPVAC team consists of law  students, a licensed clinical social worker and an outreach counselor who provide wrap‐around holistic  legal, medical, mental health and case management services to low income survivors of domestic  violence.  In addition to teaching 5 hours per week in the clinic, Teresa has also instructs all first year law  students and second year medical students about the dynamics of domestic violence and how to screen  and refer client/patients.    Prior to IPVAC, Teresa worked for Florida’s Eight Judicial Circuit Office of the State Attorney for 13 years:   first as a Child Welfare Attorney; then as a domestic violence prosecutor; and finally as the Division Chief  of County Court.  Teresa had the distinction of trying the largest child abuse case in the history of  Florida.      Teresa is a nationally recognized expert in intimate partner violence.  As such she has provided training  for the National District Attorneys Association, the Battered Women’s Justice Project, US Department of  Justice Office on Violence Against Women and Aequitas. Teresa received the Ellen Foster Award in 2000  for outstanding commitment to the betterment of children.  In 2010, she received the Community  Advocate Award from Peaceful Paths and in 2011 the Woman of Distinction Award from Santa Fe  College.    Teresa began working in domestic violence over 30 years ago as a victim advocate with the Network of  Victim Assistance in Bucks County, Pa.  She received her Juris Doctorate with honors in 1994 from the  University of Florida. Her Bachelor of Science is in Design and Marketing from Drexel University College  of Media and Design in Philadelphia, Pa. 

Intimate Partner Violence and  the Medical Community 

Disclosure This speaker has no conflicts of interest to  disclose relative to the contents of this  presentation.

Teresa Drake, J.D.  Director, The Source Program,  Levin College of Law; Adjunct Clinical Assistant Professor,  Smith College of Social Work; Affiliate Professor, Center for  Women’s Studies and Gender  Research, UF College of Liberal Arts  and Sciences [email protected]

Presentation Overview  Definitions of  Intimate Partner  Violence (IPV)  The IPV numbers  and facts  IPV screening  and referral. 

Power & Control Wheel

Definitions of IPV?  “Intimate Partner Violence” (IPV) has become interchangeable  with “domestic violence” in most literature.  It includes  domestic violence, dating violence, sexual violence and  stalking.  IPV is a pattern of coercive, controlling behaviors designed to  exert power and control over a person in an intimate  relationship through the use of intimidation, threat, physical or  psychological/emotional harm, or harassment  IPV is a learned behavior found in every socioeconomic, racial,  ethnic, cultural group in society, regardless of sexual  orientation or gender identity.

Context Determines  Type of Perpetrator  Batterer /IPV (95% of cases)  Self Defender, or response to battering/reactive  violence: one‐time response, usually women  One time assailant, not a batterer  Generally violent fighter (hothead)  Severe mental health issues.

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IPV Numbers and Facts  85% ‐ 95% of those battered in  U.S. are women  A woman is battered every 15  seconds  U.S. Surgeon General declared  that attacks by male partners are  the #1 cause of injury to women  ages 15 – 45.

IPV Numbers and Facts  Emotional effects of IPV play a  factor in ¼ of female suicides and  are the leading cause of substance  abuse among women  Over 50% of homeless women  and children were victims of IPV

IPV Numbers and Facts  AMA and CDC  say 1 in 3 women  will be the survivor of IPV at some  point in her life (rape, physical  violence and/or stalking)  CDC says 1 in 4 women have  experienced severe physical  violence by an intimate partner.

Children and IPV  In 43% of households where IPV  occurs, at least one child under the  age of 12 lives in the home  Although many parents believe they  can hide IPV from children, research  suggests that 80% ‐ 90% of these  children are aware of the violence.

 40 ‐ 60% of men who abuse  women also abuse children.

Examples of Child Exposure

Children Witnessing IPV

 Hearing threats of physical harm   Feeling tension building in home prior to assault  Being hit/threatened while in mother’s arms  Hearing/seeing assault on their mother  Being denied care because mother is injured or depressed 

 In approximately 19% of femicides, children are also killed.  71% of cases, a child either witnesses the femicide or is the first  to find body.

 Being forced to watch/participate in violence against their mother  Seeing aftermath of violent incident  Having their relationship with their non‐violent parent undermined  Being taken hostage to force mother to return home  Being enlisted by violent parent to align against mother  Experiencing the loss of a parent due to murder/suicide.

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IPV Numbers and Facts  The annual health care costs for  women who are experiencing  ongoing IPV are 42% higher than  those for nonabused women  The increased annual health care  costs for victims of IPV can  persist as much as 15 years after  the cessation of abuse  It is estimated that the cost of  IPV to the U.S. in 2012 was $10.4  billion dollars.

IPV Numbers and Facts  17% of adult pregnant women are  battered  21% of pregnant teens are  battered

IPV Numbers and Facts  Less then 1/3 of IPV incidents  are reported to law  enforcement  Women usually leave and  return 7 – 8 times before they  permanently separate from  their batterer.

IPV Numbers and Facts  In a chart review of 2873 U.S. women who gave birth, after  controlling for sociodemographic variables, tobacco, alcohol and  drug use, preeclampsia and gestational diabetes, those with a  history of IPV were 32.08 times more likely to experience  pregnancy trauma and 5.17 times more likely to experience  abruption. 

 Top 10 most common pregnancy  and delivery complications include  intimate partner violence (Medical  Board of CA) 

IPV Numbers and Facts  IPV survivors are at an increased risk of: – – – – – – – – – – –

Asthma Bladder/kidney infections Circulatory conditions Cardiovascular disease Fibromyalgia Irritable bowel syndrome Chronic pain syndromes Central nervous system disorders Gastrointestinal disorders Joint disease Migraines/headaches…

IPV Numbers and Facts – Anxiety – Depression – Symptoms of post‐traumatic  stress disorder (PTSD) – Antisocial behavior – Suicide – Low self‐esteem – Inability to trust others, especially in intimate relationships – Fear of intimacy – Emotional detachment – Sleep disturbances – Flashbacks…

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IPV Numbers and Facts – – – – – – – –

Gynecological disorders Pelvic inflammatory disease Sexual dysfunction Sexually transmitted infections,  including HIV/AIDS Delayed prenatal care Preterm delivery Pregnancy difficulties like low birth  weight babies and perinatal deaths Unintended pregnancy.

Barriers to Leaving             

SAFETY SHAME Lack of financial resources Fear that she will lose her children (custody or DCF) Belief that criminal justice system/social services will not protect Fear that no one will believe her Fear of deportation Fear of blackmail for wrongdoing by the victim Fear of “outing” Fear of repercussions from culture/religion Fear of losing support systems such as family & friends Lack of language skills Fear of what will happen to her partner.

Why Should the Medical  Community Care?  U.S. DOJ reported that 37% of all  women in the EDs for violence‐related  injured were injured by a current or  former intimate partner  44‐47% of women killed by their  intimate partners were seen in the  healthcare system for physical injuries  within one year of their murder  29% called law enforcement  4% called or went to a shelter or IPV  services.

Why Doesn’t She Just Leave  Being Beaten by a “loved” one sets  up a conflict between two  instincts:    The instinct to say in a secure  environment (family)   And the instinct to flee a  dangerous environment  There are many barriers to  leaving besides fear of the  batterer and lack of resources…

The Most Dangerous Time  The most dangerous time for a  battered woman is when she  finally decides  to leave  As many as 75% of IPV calls  made to police and 73% of the  emergency room IPV visits  occur during or immediately  following separation  Of women killed by their  abusers, 70% are killed during  the process of trying to leave. 

Why Should the Medical  Community Care?  92% of women who were physically  abused by their partners did not discuss  these incidents with their physicians  57% did not discuss the incidents with  anyone  70% ‐ 81% of the patients reported they  would like their healthcare providers to  ask them privately about IPV.

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Screening Patients for IPV

SCREEN ALL PATIENTS Not just the ones you have a “feeling” about!

ACOG Screening Recommendations  ACOG recommends that physicians screen ALL patients  for intimate partner violence. For women who are not  pregnant, screening should occur:  at routine ob‐gyn visits  family planning visits  preconception visits

 For women who are pregnant, screening should occur at  various times over the course of the pregnancy because  some women do not disclose abuse the first time they are  asked and abuse may begin later in pregnancy.  Screening  should occur:  at the first prenatal visit  at least once per trimester, and  at the postpartum checkup.

Screening Patients for IPV Always talk to the patient ALONE

Screening Patients for IPV  Begin by telling patients,  "Because violence is so common  in many women's lives and  because there is help available  for women being abused, I now  ask every patient about  domestic violence.” (ACOG)  Tell your patient that everything  she says will be confidential,  unless she discloses that her  children are being harmed by her  partner (Fla. Stat. 39.201) or your  patient is a vulnerable adult and  being harmed by a partner (Fla.  Stat. 415.1034).

ACOG Screening Recommendations

R3  Screen (free Android or iPhone app)

 Domestic violence screening can be conducted by  making the following statement and asking these  three simple questions: “Within the past year ‐‐ or since you have been pregnant ‐‐ have  you been hit, slapped, kicked or otherwise physically hurt by  someone? Are you in a relationship with a person who threatens or physically  hurts you? Has anyone forced you to have sexual activities that made you feel  uncomfortable?"

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Broad IPV Screen

Positive Screening Results Validate your patient’s feelings, which may be confusion,  worry, anger or rage.  She needs to know:  You will listen to her and believe her without judgment  She does not deserve to be battered  She has done nothing wrong  She is not alone, abuse is common problem affecting millions  of women  Help is available through the local domestic violence center  …and, that if she is not yet ready to disclose, you are a source  she can come to later.

Non‐Positive Screening Results  If the patient denies IPV, offer  her the number of the local  domestic violence center and  tell her to give it to someone  who needs it  Let her know that you are  always someone she can talk  to about IPV.

Patient Safety

If your patient has come with a partner that you suspect may  be someone she is afraid of, ask if she is safe to leave the clinic.

Results of Screen Remember, the goal of  screening is to place  resources in the hands of  women who need them, not  to get women to leave a bad  situation.

Florida’s Reporting Requirements  Tell your patient that  everything she says will be  confidential, unless she  discloses that her children area  being harmed by her partner  (Fla. Stat. 39.201)   Or your patient is a vulnerable  adult and being harmed by a  partner (Fla. Stat. 415.1034).

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Call Law Enforcement Fla. Stat. 790.24 Report of medical treatment of  certain wounds Any physician, nurse, or employee thereof knowingly  treating or asked to treat any person suffering from a  gunshot wound or life threatening injury indicating an act  or violence shall report the same immediately to the  sheriff’s department.  This does not affect child abuse or  elder abuse reporting requirements.

IPV Resources Futures Without Violence:   www.Futureswithoutviolence.org National Domestic Violence Hotline:   www.thehotline.org National Network to End Domestic Violence:   www.nnedv.org Florida Coalition Against Domestic Violence:  www.fcadv.org

Documenting The Medical Record  Documentation of patient’s  statement can be an  exception to the hearsay  laws in Florida  Diagrams, photographs, and  descriptions of injuries can  be evidence in a criminal  case.

References  Black M, Basile K, Breiding M, et al. The National Intimate Partner and Sexual Violence Survey:  2010 summary report. Atlanta: National Center for Injury Prevention and Control, Centers for  Disease Control and Prevention, 2011.  Campbell JC. Health consequences of intimate partner violence. Lancet 2002;359:1331‐1336  Nelson HD, Bougatsos C, Blazina I. Screening women for intimate partner violence: a  systematic review to update the U.S. Preventive Services Task Force Recommendation.Ann Intern Med 2012;156:796‐808  James L, Shaeffer S. Interpersonal and domestic violence screening and counseling:  understanding new federal rules and providing resources for health providers. Futures without  violence. May 2012 Sherin KM, Sinacore JM, Li XQ, Zitter RE, Shakil A. HITS: a short domestic  violence screening tool for use in a family practice setting. Fam Med 1998;30:508‐512  Leone JM, Lane SD, Koumans EH, DeMott K, Wojtowycz MA, Jensen J, Aubry RH. Effects of  intimate partner violence on pregnancy trauma and placental abruption. J Womens Health  (Larchmt). 2010 Aug;19(8):1501‐9. PMID: 20575710   Cronhom PF et al. Am Fam Physician. 2011;83(10):1165‐1172.   Center for Disease Control, www.cdc.gov

 Elder Abuse Prevalence and Incidence, National Center on Elder Abuse, 2005

Thank You Teresa Drake, J.D. Director, The Source Program,  Levin College of Law; Adjunct Clinical Assistant Professor,  Smith College of Social Work; Affiliate Professor, Center for  Women’s Studies and Gender  Research, UF College of Liberal Arts  and Sciences [email protected]

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Donald Wood, ARNP, CRNA, LHRM    Donald Wood is an Advanced Registered Nurse Practitioner with certifications in Nurse Anesthesia and  Legal Nurse Consulting. He is a Florida Licensed Healthcare Risk Manager. Mr. Wood has over 40 years  of experience in healthcare. He has administered all types of anesthesia in a variety of inpatient and  outpatient settings and spent 17 years as a chief anesthetist. During that time, he was also involved in  nursing education, hospital safety committees, EMR setup/management, and medical simulations. Mr.  Wood is an author and speaker having presented to audiences at the local, state and national level.   

Disclosure

Prevention of Medical Errors ACOG District XII – Orlando FL August 17, 2014

We would like to disclose that Donald Wood, as an employee of The Doctors Company, has a financial interest in The Doctors Company, an organization that may have a direct interest in the subject matter of this presentation.

Donald Wood, ARNP, CRNA, CPHRM Patient Safety/Risk Manager

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Course Objectives

Adverse Event

At the conclusion of this presentation, participants should be able to:

• Definition

• Identify medical error reduction and prevention measures • Identify patient safety goals

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• Error that causes an injury to a patient as the result of a medical intervention rather than the underlying medical condition. • Represents an unintentional harm arising from any aspect of healthcare management.

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Incidence of Adverse Events

Preventable Adverse Event

• 2008 Study of 780 Medicare patients

• Individual and/or system level • Resulting from • Active failures • Latent failures



Adverse event rate of 13.5% • Related to medication: 31% • Related to patient care: 28% • Related to surgery/procedures: 26% • Related to infection: 15% • Physician review of preventability • Likely or clearly preventable 44% • Likely or clearly not preventable 51% • Unable to determine 5% Prevention of Medical Errors / 5

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Failure Types

Active Failures • Committed by those in direct contact with patient • Unsafe Acts:

Sharp end Active

Blunt end Latent

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• Slips–the action did not occur as intended • Lapses–missed actions and omissions, usually associated with inattention, distraction, forgetting • Not following guidelines

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Active Failures (continued)

Latent Failures

• Mistakes–faulty plan or intention • Violations–deliberate variance from a required procedure

• Errors in the system by designers, leaders, others distant from the patient • Time pressure • Staffing • Inexperienced personnel • Inadequate equipment • New technology

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Factors that Harbor Latent Failure • • • • •

Swiss Cheese Model - 1

Too much variability Lack of reliability Lack of checklist use Lack of briefing and huddles Low communication expectations

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Swiss Cheese Model - 2

What We Know • High Reliability Organizations • Understand human error is inevitable • Construct safer processes - mitigate human factors • Avoid reliance on memory and vigilance • Use teamwork • Smart use of technology • Need emphasis on patient safety

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System Design Flaws

Prevalent Medical Errors

1. 2. 3. 4. 5.

• • • • •

Insert card Enter PIN Enter amount Remove money Remove card

Nosocomial infections=75,000 deaths/year1 Medication errors=1.5 million people/$3.5 billion2 Medication errors=7,000 deaths/year3 Allergic reactions=700,000 to ER/year4 Wrong surgeries=1,700-2,700/year5

1. 2. 3. 4. 5.

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CDC, 2011 IOM, 2006 IOM, 2006 JAMA (10/2006) Archives of Surgery (Sept. 2006)

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Frequent Root Causes • Human Factors •

Staffing, education, bias, supervision, and complacency

• Leadership •

Organizational culture, priorities, policies and procedures

• Communication •

Among staff, with patient, oral, written

The Joint Commission Prevention of Medical Errors / 17

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Communication Errors • • • •

A prevalent root cause of medical errors is communication.

Failure to educate and inform Miscommunication Health literacy issues Failed crucial conversations

A common issue in claims is communication…

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Effective Communication

Communications Error Prevention

• Patients usually interrupted after ____ ? • On average, patient would speak _____ ? • Short-term investment=long-term payoff

• • • • • • • • •

• • • •

Improved compliance Focused interactions Realistic expectations Enhanced rapport

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Low Health Literacy • 90 million people have literacy related health risks • 1 out of 5 read at _______ grade level • 50%–Understand directions for taking medications correctly

Patient-centric culture Awareness Training Protocols–checklists Language Visual aids Limit and repeat Ask Me 3 Verify with teach back Prevention of Medical Errors / 22

Low Health Literacy (continued) • The ability to obtain, read, understand and use healthcare information • Risk factors for low health literacy • • • • •

Elderly Less than high school education Poverty Recent immigrant English as a second language

• YouTube – AMA health literacy www.npsf.org Prevention of Medical Errors / 23

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Case Summary

Root Causes for Missed Diagnosis

CC: Fever, malaise, body aches Dx: Influenza Tx: Treat symptoms. Bed rest

Outcome: DID, Meningitis–Death

• • • • •

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Clinician—Clinician Communications • • • • •

Referrals Medical clearance Hospitalists Site to Site Handoff: SBAR Report • • • •

Situation Background Assessment Response or request

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Diagnostic Error Prevention Tracking and recall systems – most common cause of claims arising from office practice • • • • •

Failure to follow up diagnostic results Results filed before review Results not given to the patient Plan of care not altered due to results 30%–medical practices fail to document review

Personal bias Haste Misguided axioms Poor history Inadequate examination • Anchoring

• Failed evaluation and pursuit • Inadequate followup systems • Faulty communication of clinical concerns

Case Summary • 42 y/o female c/o breast lump. PCP orders screening mammogram. “Will call if abnormal.” • No follow-up appointment. Results were filed in chart and a copy sent to her gynecologist. • 14 months later at gynecologist appointment patient c/o “breast pain”. • Diagnostic mammogram indicates “lesion larger than previous”. • Two years later patient expired–metastatic breast cancer. Prevention of Medical Errors / 28

Systems Error: Wrong Procedure • 58% ambulatory settings • 29% in-patient OR • 13% other in-patient settings–ER, ICU • 76% wrong body part or site • 13% wrong patient •__________________________________ 11% wrong surgical procedure ______ • Communication–78% of cases • Orientation and training–45% of cases The Joint Commission

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Wrong Procedure Root Causes

Case Summary

• • • • •

• Two female patients scheduled for breast surgery by same surgeon • Surgeon arrived after first patient prepped and draped • Performed (R) total mastectomy • Surgeon to holding area, informed that his mastectomy patient was “ready” • First patient scheduled for right breast biopsy only

Communication breakdown Poor patient preparation Wrong information provided by patient/parent Errors in consent, records or scheduling X-ray interpretation and report language errors

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Wrong-Site Procedure FAC 64B8-9.007 (2) “…requiring the team to pause…” (b) “…record shall specifically reflect...”

Florida Statute 456.072(1)(bb) “Performing or attempting to perform…” “… includes the preparation of the patient.”

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Department of Health • Wrong-Site Sanctions (first offense) • Letter of Concern • $5,000 fine • Costs of investigation and processing (@$2,500) • Five CME’s Risk Management • One hour lecture–develop and deliver

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Surgical Error Prevention • • • • •

Identification – verification protocol Mark site – visible after draping Patient education and preparation Consent/Education Protocols – Training

Prevention of Medical Errors / 34

Surgical Complications • Most claims entail acceptable medical complications • Failure to supervise/monitor post-op is the most prevalent root cause of medical error • Prevalent post-op complications: • • • •

Infection Perforation Suture failure Bleeding

Prevention of Medical Errors / 36

6

Case Summary

Medication Errors

• 47 year old, repair of herniated disc L4-5 • Persistent low blood pressure in PACU

• Leading cause of harm in hospitals

• Given a fluid challenge – minimal change • Anesthesiologist notified three times

• 28% preventable • 62% ordering and transcription

• Transferred to floor – hypotensive • Became unresponsive two hours later • Code called – hematocrit 14 • Torn left iliac vein

Prevention of Medical Errors / 37

Prevention of Medical Errors / 38

Roots and Herbs and OTCs

Medication Error Root Causes

• Make sure you get and check the patient’s entire list of both prescribed and OTC meds

• • • • •

• Brown bag medication reconciliation

• Anticoagulant patients taking Vitamin E, CoQ10 and garlic • Liver failure from large doses of vitamins A, D, E, and K

Prevention of Medical Errors / 39

• Klonopin

-

• Lanoxin

-

• Hydralazine

-

• Evista

-

• Alprazolam

-

• Vicodin

-

(heart failure/AF)

(anti-hypertensive) (osteoporosis) (anti-anxiety)

Prevention of Medical Errors / 41

• • • •

Concentrations LASA medications Patient understanding Unfamiliar medication

Prevention of Medical Errors / 40

LASA Medications (anti-anxiety)

Illegibility V.O and T.O Abbreviations Multiple medications Multiple prescribers

LASA Medications (continued) Clonidine

(anti-hypertensive)

Levoxine

(Thyroid tx)

Hydroxyzine

(anxiolytic)

Avinza

(extended release Morphine)

Lorazepam

(anti-anxiety)

Vicodin ES

Prevention of Medical Errors / 42

7

Medication Error Prevention • • • • • •

Review chart Written information Warnings Refill protocols Medication reconciliation Medication/Allergy alerts

“Make it easy to do right and difficult to do wrong.” - Dr. Lucian Leape

Prevention of Medical Errors / 43

Prevention of Medical Errors / 44

2014 National Patient Safety Goals

2014 National Patient Safety Goals (continued)

• Patient ID

• Prevent Infections

• •

At least two ways Correct patient, blood for transfusions

• Medication safety • • • •

All medications labeled Extra care with patients on anticoagulants Medication reconciliation Review up-to-date med list every visit

Prevention of Medical Errors / 45

Your Role in Reducing Medical Error • • • • •

Take the lead Establish a safety culture Promote effective team functioning Anticipate the unexpected Create an environment of trust and cooperation

• Hand washing • Use proven guidelines

• Prevent mistakes in Surgery • Correct patient, site, surgery • Mark the site • Pause before the procedure

Prevention of Medical Errors / 46

Mission Statement [email protected] (800) 421-2368 x 3374

Our mission is to Advance, Protect, and Reward the Practice of Good Medicine

PRIMUM NON NOCERE Prevention of Medical Errors / 47

Prevention of Medical Errors / 48

8

 

 

Donald Wood ARNP, CRNA, LHRM 

Patient Safety Risk Manager,  (800) 421‐2368, Extension 3374  [email protected]     Prevention of Medical Errors  Adverse Event  •

Definition  •

Error that causes an injury to a patient as the result of a medical intervention rather  than the underlying medical condition. 



Represents an unintentional harm arising from any aspect of healthcare management. 

Preventable Adverse Event  • Individual and/or system level  • Resulting from  • Active failures  • Latent failures      Active Failures  • •

Committed by those in direct contact with patient  Unsafe Acts:   • Slips–the action did not occur as intended  • Lapses–missed actions and omissions,   usually associated with inattention, distraction,  forgetting  • Not following guidelines    Mistakes–faulty plan or intention  Violations–deliberate variance from a required procedure 

• •   Latent Failures  • Errors in the system by designers, leaders, others distant from the patient  • Time pressure   • Staffing   • Inexperienced personnel  • Inadequate equipment  • New technology    Factors that Harbor Latent Failure  • Too much variability   • Lack of reliability   • Lack of checklist use   • Lack of briefing and huddles  • Low communication expectations 

 

 

Donald Wood ARNP, CRNA, LHRM 

Patient Safety Risk Manager,  (800) 421‐2368, Extension 3374  [email protected]       

Swiss Cheese Model (from Reason)  o Each slice of cheese is a person, policy, procedure, etc.  o The holes in the cheese are constantly opening, closing, and moving   You come into work one day and don’t feel good – you have more holes in your  cheese   You are using a new piece of technology for the first time – more holes in your  cheese   You are using a checklist when performing a procedure – fewer holes in your  cheese 

What We Know    • High Reliability Organizations  • Understand human error is inevitable   • Construct safer processes ‐ mitigate human factors  • Avoid reliance on memory and vigilance  • Use teamwork   • Smart use of technology  • Need emphasis on patient safety    Frequent Root Causes  • Human Factors  • Staffing, education, bias, supervision, complacency  • Leadership  • Organizational culture, priorities, policies and procedures  • Communication  • Among staff, with patient, oral, written    Communication Errors  • Failure to educate and inform  • Miscommunication  • Health literacy issues  • Failed crucial conversations    Effective Communication  • Patients usually interrupted after ____ ?  • On average, patient would speak _____ ?  • Short‐term investment=long‐term payoff  • Improved compliance  • Focused interactions 

 

 

Donald Wood ARNP, CRNA, LHRM 

Patient Safety Risk Manager,  (800) 421‐2368, Extension 3374  [email protected]     • •

Realistic expectations  Enhanced rapport 

  Communications Error Prevention   • Patient‐centric culture  • Awareness    • Training  • Protocols–checklists  • Language  • Visual aids  • Limit and repeat  • Ask Me 3  • Verify with teach back    Low Health Literacy  • 90 million people have literacy related      health risks  • 1 out of 5 read at _______ grade level  • 50%–Understand directions for taking medications correctly  • Risk factors for low health literacy  • English as a second language  • Less than high school education  • Elderly  • Recent immigrants  • Living at or below poverty level  • Check out YouTube – search term “AMA low health literacy”  Clinician—Clinician Communications  • Referrals  • Medical clearance  • Hospitalists  • Site to Site  • Handoff:  SBAR Report   • Situation  • Background  • Assessment  • Response or request     Root Causes for Missed Diagnosis  • Personal bias  • Haste  • Misguided axioms 

 

 

Donald Wood ARNP, CRNA, LHRM 

Patient Safety Risk Manager,  (800) 421‐2368, Extension 3374  [email protected]     • • • • •

Poor history  Inadequate examination  Failed evaluation   and pursuit  Inadequate follow‐   up systems  Faulty communication of clinical concerns 

  Diagnostic Error Prevention   • Tracking and recall systems – most common cause of claims arising from office practice  • Failure to follow up diagnostic results   • Results filed before review  • Results not given to the patient  • Plan of care not altered  due to results  • 30%–medical practices fail to document review  • A good history is imperative      • Evaluate and document signs and symptoms  • Document the negatives  • Diagnostic pursuit–index of suspicion  • Referral and follow‐up        • Clarify responsibilities     • Manage non‐compliance  • Monitor follow‐up appointments    Systems Error: Wrong Surgery  • 58%  ambulatory settings   • 29%  in‐patient OR   • 13%  other in‐patient settings–ER, ICU   • 76%  wrong body part or site   • 13%  wrong patient  • 11%  wrong surgical procedure  ________________________________________  • Communication–78% of cases  • Orientation and training–45% of cases    Wrong Surgery Root Causes  • Communication breakdown  • Poor patient preparation   • Wrong information provided by patient/parent  • Errors in consent form and medical records  • X‐ray interpretation and report language errors  • Unusual time pressure, equipment or set‐up 

 

 

Donald Wood ARNP, CRNA, LHRM 

Patient Safety Risk Manager,  (800) 421‐2368, Extension 3374  [email protected]     •

Multiple procedures–multiple surgeons  

  Wrong‐Site Surgery  • FAC 64B8‐9.007  • (2) “…requiring the team to pause…”  • (b) “…record shall specifically reflect...”  • Florida Statute 456.072(1)(bb)  • “Performing or attempting to perform…”   • “… includes the preparation of the patient.”     Surgical Error Prevention   • Identification – verification protocol   • Mark site – visible after draping  • Patient education and preparation  • Consent/Education  • Protocols – Training    Surgical Complications  • Most claims entail acceptable medical complications  • Failure to supervise/monitor post‐op is the most prevalent root cause of medical error   • Prevalent post‐op complications:    • Infection   • Perforation  • Suture failure   • Bleeding   • Bad situations, left alone, usually get worse      Medication Errors  • Leading cause of harm in hospitals  • 28% preventable  • 62% ordering and transcription    “Roots and Herbs” and OTCs  • Make sure you get and check the patient’s    entire list of both prescribed and OTC meds   • Anticoagulant patients taking Vitamin E, CoQ10 and garlic  • Liver failure from large doses of vitamins A, D, E, and K    Medication Error Root Causes  • Illegibility 

 

 

Donald Wood ARNP, CRNA, LHRM 

Patient Safety Risk Manager,  (800) 421‐2368, Extension 3374  [email protected]     • • • • • • • • • • • •

V.O and T.O  Abbreviations  Multiple medications  Multiple prescribers  Concentrations  LASA medications (Look Alike, Sound Alike)  Patient understanding  Unfamiliar medication  Concentrations  LASA medications  Patient understanding  Unfamiliar medication 

  LASA Medications  • Klonopin  (anti‐anxiety)                        Clonidine (anti‐hypertensive)                                      • Lanoxin    (heart failure/AF)                       Levoxine  (Thyroid tx)                        • Evista    (osteoporosis)                          Avinza  (extended release Morphine  • Lamisil   (anti‐fungal)                       Lamictal  (anti‐seizure)                                     Also see the website for the Institute for Safe Medication Practices  http://ismp.org/Tools/confuseddrugnames.pdf    Medication Error Prevention  • Electronic ordering or fax  • Pre‐printed scripts  • Brand and generic names  • Medication’s purpose   • Limit verbal/telephone orders  • Review chart  • Written information  • Warnings   • Refill protocols  • Medication profile  • Medication/Allergy alerts    2014 National Patient Safety Goals  • Patient ID   • At least two ways  • Correct patient, blood for transfusions 

 

 

Donald Wood ARNP, CRNA, LHRM 

Patient Safety Risk Manager,  (800) 421‐2368, Extension 3374  [email protected]     •

Medication safety  • All medications labeled  • Extra care with patients on anticoagulants  • Medication reconciliation  • Review up‐to‐date med list every visit  • Prevent Infections  • Hand washing  • Use proven guidelines   • Prevent mistakes in Surgery  • Correct patient, site, surgery    • Mark the site  • Pause before the procedure 

  Your Role in Reducing Medical Error 

 



Take the lead 



Establish a safety culture 



Promote effective team functioning 



Anticipate the unexpected 



Create an environment of trust and cooperation 

William Hambsh, CPA, CPME    Bill Hambsh is a Florida native from Clearwater, Florida. He transferred up to Tallahassee in 1992 to  complete his Master’s Degree in Accounting and obtained his CPA license in 1995. He has been with  North Florida Women’s Care since 1998. He has also received the recognition as a Certified Medical  Practice Executive (CMPE) with the Medical Group Management Association (MGMA).     Bill serves on the National Executive Committee of OB/GYNs through MGMA, is a member of the ACOG  (American College of Obstetricians & Gynecologists) Committee on Ambulatory Practice Operations and  is the current Chairman of the March of Dimes Big Bend Division Board. He is a past Board member of  the Tallahassee Chamber of Commerce and past chairman of the Chamber Ambassadors. He volunteers  his time with many health related organizations.     He spends his free time traveling, exercising, reading, cycling and playing musical instruments. 

Disclosure SOCIAL MEDIA and YOUR PRACTICE

This speaker has no conflicts of interest to disclose relative to the contents of this presentation.

Presented by Bill Hambsh, CPA, CMPE Sunday, August 17, 2014

OBJECTIVES     

North Florida Women’s Care

What is Social Media? Benefits of Social Media Define Your Online Reputation Creating a Social Media Plan Navigate Facebook, Twitter, Linked‐In, YouTube

11  Physicians

Locations  Tallahassee (Leon County)  Perry (Taylor County)  Carrabelle (Franklin County)

Patient mix 0 – 18 Years 19 – 34 Years 35 – 44 Years 45 – 54 Years 55 – 64 Years 65 – 74 Years 75  ‐ 84 Years 85+ Years

0.6% 39.1% 21.9% 17.9% 11.7% 5.5% 2.4%  0.9%

1

What is social media?

Communication has changed &  continues to change

WHAT WAS…

What WILL BE…

WHAT IS…

A society trained to research online

 72% look online for health  information  44%look online for physician  information  Google yourself once a week

Google Alerts

Types of social media  Social Networks (Facebook, Twitter, Google+, Linked‐In)  Blogging (Blogger, Tumblr, WordPress, MomsLikeUs)  Media Sharing (YouTube, Flickr, Vine, Instagram, Pinterest)  Q&A (Quora, Stack, Ask, Overflow)  Reputation (Yelp, HealthGrades, Vitals, ZocDoc, RateMDs)

2

Why is it so important?

THE SNEEZE PRINCIPLE   A visitor views a post, event, picture, blog that you create.  They  like it and share it with their friends.  This is the Sneeze Effect. A  few of these individuals also like it and share it with their friends.   One person sneezing can cause others to sneeze. This is where people are collecting information about anything or  anyone.

Creating Your social media plan  Know your audience  Review your site for social skills  Preparing for social media greatness  Finding your message  Setting your routine

Finding and keeping  Promote throughout office &  literature  Electronic campaign  Recruit staff to help  Q&A (LinkedIn, Twitter, Blogs)  Reply to posts  Create Events  Stay connected

The benefits of social media  Low Costs  Reach out to patients  Reach out to physicians (Sermo)  Communication is quick  Simple to use  Build brand recognition  Increases your online ranking  Recruit new employees  Strengthens your reputation

Building your network  Finding & keeping friends  Expanding your network with Q & A  Provide meaningful content  Interact with your patients  Stay actively involved  Behaving yourself in social media

Connecting with Audience  Find Ghost Writers  Answer specific questions (Menopause &  Infertility – hot topics)  Write lists (Screenings at various ages)  Use graphics   Pull from real patient issues but protect privacy  Ask for testimonials  Timeliness in activity  Provide contact information

3

Navigating the social media sites  Networking with Facebook, Twitter,  LinkedIn, Others…  Growing your practice with multimedia  Talking in discussion forums  Using Twitter as a launchpad  Building your reputation with Quora  Using the power of niche sites

Do’s & Don’ts of social media DOs        

Remain professional Educational content Be relevant Be engaged Give great answers Set up a routine Market your presence Monitor performance

DON’Ts     

Use as political forum Delay in posting Sales pitch style Don’t post angry Respond to negative posts or  reviews  Share PHI information  Sell patient information

Rating Websites       

Healthgrades.com RateMDs.com ZocDoc.com Vitals.com Google.com Yelp.com Insurance Carrier Websites

4

Facebook     

Photo Albums Events Announcements When to post Who will post

5

TWITTER     

Connect in real‐time Limited to 140 characters  Keep audience informed Engage patients in conversation Twitter keeps people updated on the here and now

Linked‐In      

Establish your professional profile Network of professionals Create a compelling “Summary” Linked‐In helps with searches on Google Update information routinely Link Twitter to Linked‐in

6

YouTube       

Google Places

Welcome Video to Practice Video Bios Commercial about your practice Patient Education Content Demonstrate your expertise The potential for “Going Viral” Use to recruit staff

Homework  Create a Facebook Page  Create a Twitter Account  Create a YouTube Channel  Create a Linked‐In Account  Create HootSuite Account  Google your name and practice name  Set up Google Places  Get patients to write reviews

7

Questions

Bill Hambsh, CPA, CMPE North Florida Women’s Care www.NFLWC.com [email protected]

8

David A. Grimes, MD    David Grimes is one of a small number of U.S. physicians Board certified in both obstetrics and  gynecology and in preventive medicine.  He obtained his undergraduate degree in biology from Harvard  then attended medical school as a Morehead Fellow at the University of North Carolina.  He completed  his residency in obstetrics and gynecology at that institution, interrupted by two years at the U.S.  Centers for Disease Control and Prevention.    Dr. Grimes has had a dual career in clinical ob/gyn and in preventive medicine for the past three  decades.  He served as an epidemiologist at the Centers for Disease Control for nine years.  He has also  been a faculty member in four medical schools:  Emory University, University of Southern California,  University of California‐San Francisco, and University of North Carolina.  He has received teaching  awards from medical students and residents at each of these schools.  Through the auspices of the  Berlex Foundation and Exxcellence Foundation Faculty Development Courses, he has taught research  methods to over 2000 obstetricians/gynecologists in the U.S.  Through the Centers for Disease Control  and Prevention and FHI, he has taught research methods to physicians and scientists in Kenya, Ethiopia,  India, Egypt, and Bangladesh. In 2002, he and colleague Kenneth F. Schulz, Ph.D., M.B.A. authored an 11‐ part series on research methods in The Lancet.  A second installment of 5 additional articles appeared in  The Lancet in 2005.  These 16 essays were published by Elsevier in 2006 (The Lancet Handbook of  Essential Concepts in Clinical Research).  He is also an editor of Management of Unintended and  Abnormal Pregnancy: Comprehensive Abortion Care published by Wiley‐Blackwell in 2009.    Dr. Grimes’ research interests have focused on fertility regulation, technology assessment, sexually  transmitted diseases, and clinical epidemiology.  He has published 390 peer‐reviewed articles, fifty  textbook chapters, and ten books.  In 1994, he received the Issue of the Year Award and in 1997 the  Distinguished Service Award from the American College of Obstetricians and Gynecologists.  In 2006, he  was elected to the Institute of Medicine of the National Academies of Science.  He was elected an  Honorary Fellow of the Royal College of Obstetricians and Gynaecologists in 2007.    He currently serves as Clinical Professor in the Department of Obstetrics and Gynecology at UNC.  

SCREENING TESTS: HOW TO RUIN A PERFECTLY GOOD MARRIAGE

DISCLOSURES 



David A. Grimes, M.D. UNC School of Medicine Chapel Hill, NC

CONSULT, PLEASE! 

 



Physician’s wife gets cervical cytology, gonorrhea, and chlamydia screening at routine office visit with resident Gonorrhea test returns positive Resident has rotated to outside hospital You are asked to follow up with the patient…..

I have financial conflicts of interest relevant to this presentation. I serve on several Data Safety Monitoring Boards for clinical research sponsored by Bayer

YOUR OPTIONS….. Tell the patient she has gonorrhea  Repeat the test  Get a gonorrhea culture  Ignore the report  None of the above 

1

OBJECTIVES    





SCREENING DEFINED

SCREENING SEMANTICS



Testing of a large group of apparently well persons to identify those with a high (Pap) probability of disease  (Colposcopy/biopsy)

Diagnostic test 

(Frostbite)

Treatment

Define screening Define validity and its four indices Calculate these indices Describe the relationship between sensitivity and specificity Describe the impact of prevalence on predictive values Name two screening biases

Can a pregnant diabetic woman be screened for hypertension? No, since she is not “apparently well” Looking for other disease: “casefinding”

CRITERIA FOR A SCREENING TEST  

 

Important disease Diagnostic and treatment facilities available Latent period Relatively prevalent disease

 

 



Acceptable test Reliable (reproducible) test Valid test Appropriate to the population screened Cost is reasonable

2

SCREENING VS. DIAGNOSIS?

SCREENING VS. DIAGNOSIS SCREENING  Simple  Low reliability  Non-physician  Apparently well persons

DIAGNOSIS  Complex  High reliability  Physician  Done for indications

Stool guaiac test  Sigmoidoscopy  Serum cholesterol  Blood pressure  Electronic fetal monitoring in labor (TO BE REVISITED….) 

MEASURING TEST PERFORMANCE 





Validity: ability of a test to distinguish between disease and health 4 indices widely used since the 1940’s Indices relate to populations, not persons

Yes

Sensitivity: the ability of a test to identify those with the disease  Specificity: the ability of a test to identify those without the disease

No

True positive

False Positive

Pos

a

b

TEST

False negative

True negative

Neg

c

d

THE WORLD IN A BOX

SENSITIVITY AND SPECIFICITY 

DISEASE

Yes

DISEASE

No

True positive

False Positive

Pos

a

b

TEST

False negative

True negative

Neg

c

d

Sensitivity = a/(a+c)

3

Yes

DISEASE

No

True positive

False Positive

Pos

a

b

TEST

False negative

True negative

Neg

c

d

Specificity = d/(b+d)

WHAT CLINICIANS CARE ABOUT Predictive value positive: the likelihood that a person with a positive test has the disease and, the flip side, Predictive value negative: the likelihood that a person with a negative test does not have the disease

MNEMONICS

Yes

Thinking vertically: epidemiologists and lab directors, upright citizens in the medical community (columns in the 2x2 table) Thinking horizontally: clinicians who commonly meet patients horizontally (rows in the 2x2 table)

DISEASE

No

True positive

False Positive

Pos

a

b

TEST

False negative

True negative

Neg

c

d

Predictive value positive = a/(a+b)

Yes

DISEASE

No

True positive

False Positive

Pos

a

b

TEST

False negative

True negative

Neg

c

d

•Given disease, how likely is the test to be positive? •Given health, how likely is the test to be negative? •Given a positive test, how likely is the person to be sick? •Given a negative test, how likely is the person to be well?

Predictive value negative = d/(c+d)

4

GAMBINO’S RULE OF THUMB

WARTY DYSPLASIA Yes No Pos PAP TEST

15

5

a

b

10

70

c

d

Neg

Good test: sensitivity plus specificity >1.5

Sensitivity = 0.60

PVP = 0.75

Specificity = 0.93

PVN = 0.88

Very good test: sensitivity plus specificity >1.8

1000 Pap smears 1000 Pap smears

35 Positive

Colposcopy/biopsy

20 Positive

15 Negative

The Pap test is a “highly accurate” test, since the falsepositive rate is only 1.5%.

965 Negative

35 Positive

Colposcopy/biopsy

125 Positive

Agree? 20 Positive

15 Negative

Am J Obstet Gynecol (ancient)

Pos PAP

No

Tests may complement each other

20

15

RPR +

TEST Neg

Hypothetical (bogus) example

SCREENING TESTS IN SEQUENCE

DYSPLASIA Yes

840 Negative

125 840 Sensitivity = 0.14

PVP = 0.57

Specificity = 0.98

PVN = 0.87

-

MHA-TP +

-

Diagnosis requires both a sensitive but nonspecific reagin test, then a specific treponemal test

Diagnosis of syphilis

5

DIAGNOSING DEATH, VATICAN STYLE “The cardinal camerlengo confirms the pope’s death by calling him by his baptismal name (Karol) three times. If the pope doesn’t answer, the camerlengo says the pope is dead.” USA Today, April 4, 2005, page 6A

PROBLEMS WITH VATICAN DEATH TEST PERFORMANCE

Diagnosing Death: Where Do You Draw The Line? A

Test: “Are you dead yet?”

B

C

Sensitivity: 100% Specificity: Not so hot Predictive values: Unknown

Dead

Alive (Low)

Plasma Putrescine Level

(High)

6

No. of Persons

Sensitivity 100%

Specificity 100%

AN INVERSE RELATIONSHIP 

Alive



Dead 0

5

10

15

Sensitivity and specificity are inversely related Where you put the cutoff for continuous variables should reflect the impact of getting the wrong answer

Plasma Putrescine mg/dl

OVERLAP

CUTOFF HERE

SPECIFICITY 100%

No. of Persons

FALSE NEGATIVE TESTS

DIABETES EXAMPLE

Well

PREVALENCE PROBLEMS 



Sick

The frequency of disease in the community influences the predictive values of tests, a fact not widely appreciated Marriages are breaking up today because of clinicians’ naiveté

Test Value

A NEW TEST FOR CHLAMYDIA 

ChlamydiaQuik™ (Grandiose Technologies, Inc., Dismal Seepage, OH)



 

A superb test by Dr. Gambino’s criteria: Sensitivity = 0.95 Specificity = 0.95

THE IMPORTANCE OF PREVALENCE: CHLAMYDIA (30%) Yes No Pos

285

35

15

665

300

700

TEST Neg

Sensitivity = 0.95

PVP = 0.89

Specificity = 0.95

PVN = 0.98

7

THE IMPORTANCE OF PREVALENCE: CHLAMYDIA (5%) Yes No

COMMITMENT 



Based on a positive ChlamydiaQuik™ in the health department STD clinic with a prevalence of 30%, would you be willing to prescribe azithromycin 1.0 g by mouth for her?

Pos

Neg

Her partner?

COMMITMENT, revisited 

In your office, with a Chlamydia prevalence of 5%, would you be willing to prescribe azithromycin 1.0 g by mouth for her?





Her partner?

47

2

903

50

950

Sensitivity = 0.95

PVP = ?

Specificity = 0.95

PVN = 1.00

CONSULT, PLEASE!

 

48

TEST



Physician’s wife gets cervical cytology, gonorrhea, and chlamydia screening at routine office visit with resident Gonorrhea test returns positive Resident has rotated to outside hospital You are asked to follow up with the patient…..

BACK TO THE DOCTOR’S WIFE GONORRHEA

Yes Pos PCR

No

GONORRHEA GOOFS

97

198

With a prevalence of 1%, the predictive value positive of the PCR is about 0.33

3

9702

With a prevalence of 1 per 1,000, the predictive value positive falls to about 0.05

100

9,900

Neg

Sensitivity = 0.97

PVP = ?

Specificity = 0.98

PVN = ?

Stated alternatively, 19 times out of 20 a positive PCR test (a superb test) is wrong

8

AND FINALLY, HOW DOES ALL THIS RELATE TO ELECTRONIC FETAL MONITORING?

FUTILITY OF ELECTRONIC FETAL MONITORING

ROC CURVE: A PLOT OF THE TRUE-POSITIVE VS. FALSE-POSITIVE RATE

GADS, GRIMES, NOT MORE NEW TERMS! Not really…. True-positive rate = sensitivity False-positive rate = 1-specificity

Truepositive rate

(We’ve already calculated these, so no more effort needed) False-positive rate

9

Volume 172, Number 5 Am J Obstet Gynecol

. . . 5 mm 4 mm 3 mm

100

..

90

.

.

6 mm 7 mm

80 70 60 50 40 30 20 10 0

. 8 mm . 9 mm . . .. . .. .. . .. .. .. . . 0

10

20

30 40 50 60 70 1 – Specificity (%)

80

90

100

Fig. 2. Receiver-operator characteristic curve illustrating sensitivity and 1-specificity for different cutoff levels of endometrial thickness from 1 to 72 mm. Figures under graph illustrate endometrial thickness in millimeters.

LENGTH BIAS

LEAD-TIME BIAS

Cancer starts

Symptoms, signs

Screen

Death

Preclinical phase Diagnosis-to-death

Screening diagnosis-to-death

Increase in longevity due to earlier diagnosis

1990

Time

2000

SUMMARY  





Screening ≠ diagnosis Sensitivity, specificity, and predictive values measure test validity Remember the table shell and definitions; disease is the “top” priority Sensitivity and specificity are inversely related

Ecological fallacy: Telephone poles and heart disease

10

 Screening

tests perform better in high-prevalence populations  Predictive values are influenced by disease prevalence  Lead-time and length bias occur in the absence of randomized trials

11

Julie DeCesare, MD    Dr. Julie Ann Zemaitis DeCesare was born and raised in Pittsburgh, Pennsylvania.  She received  her RN/BSN from Catholic University of America in 1994, and completed her MD from Eastern  Virginia Medical School in 1998.  She completed her residency at The University of Florida‐ Pensacola Obstetrics and Gynecology Residency Program in 2002.  She is board certified in  Obstetrics and Gynecology, and a Fellow in the American College of Obstetrics and Gynecology,  and also serves as a Board Examiner for the American Board of Ob/Gyn.  She is currently an  Associate Professor, and Residency Program Director at the Florida State University Obstetrics  and Gynecology Residency Program as well as Director of Medical Education in Obstetrics and  Gynecology at Florida State University. She has won several teaching awards, including the  national CREOG faculty award.      Clinical interests include pelvic floor and vaginal reconstructive surgery, care of pregnant  patients with substance abuse issues, and the development of patient centered care in  obstetrics. Current active research includes the “Go For It Trial”‐ prep for residency bootcamp,  CenteringPregnancy and LARC usage, Postpartum Depression.  She is active in many state and  national committees.  She is currently the ACOG District XII Chair for Underserved Women, is a  member of the CREOG Milestones committee, and well as the APGO taskforce for faculty  development.     Dr. Julie DeCesare is married to Dr. Steven DeCesare, a Gynecologist Oncologist, and they have  three children; Ana (11), Steven (10) and Kiera (7) – and a bulldog named Chloe.  Her hobbies  include jogging, coaching youth soccer and reading historical fiction.

1

2

3

4

5

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Ashlyn H. Savage, MD    Ashlyn Savage is an Assistant Professor of Obstetrics and Gynecology at the Medical University of South  Carolina.  She also serves as the Residency Program Director and Director of the Colposcopy Clinic.  Dr.  Savage earned her Bachelor of Science from Tulane University and then enrolled in medical school at the  Medical University of South Carolina.  She completed her residency training in Obstetrics and  Gynecology at Magee Women’s Hospital at the University of Pittsburgh.  Her clinical and scholarly  interests include pre‐invasive cervical disease, adolescent gynecology, and contraception.    Dr. Savage is a dedicated member of the core of educators within her department.  Her teaching  activities have been rewarded with a CREOG National Faculty Award as well as the Leonard Tow  Humanism in Medicine Award.  She recently completed the Program for Medical Educators at the  Harvard Macy Institute, which was funded by a national scholarship from the Arnold Gold Humanism in  Medicine Society.  Dr. Savage is an active member of several organizations, including APGO‐CREOG, the  American Society for Colposcopy and Cervical Pathology (ASCCP), and the American College of  Obstetricians and Gynecologists (ACOG).  She recently completed a two year term on the ACOG Practice  Bulletin Committee for Gynecology. 

Disclosures The Well-Woman Visit: If not for Pap smear, then what?

 None

Ashlyn H. Savage, MD, MSCR Associate Professor, Ob/GYN Medical University of South Carolina

Objectives At the end of this presentation, participants should be able to:

The Scene…. Great news…I’ve reviewed your history and you don’t need a Pap today…or even next year

That is fabulous…I really wasn’t looking forward to that

 Discuss the benefits of clinical breast and pelvic

But wait… Do I even need an exam?

Do I need to come back next year?

exam  Identify the age appropriate components of well-

woman care

That’s a good question! The real questions at hand:  Is there benefit to clinical breast and pelvic exam in the

asymptomatic woman?  What other services are we providing?  What else is involved in well-woman care?  In the current and future system of health care, are we

primary care providers?

“Tipping a sacred cow”  Applying a critical lens to preventive interventions is

especially important because clinicians must be assured that their interventions will, on average, enhance the future health of currently healthy people without causing illness in the present.  In our pursuit of defining such interventions, there are no sacred cows.  The benefits and harms of pelvic examinations in asymptomatic

women should continue to be scrutinized. If these examinations are found to provide net benefit, they should be continued and promoted; if not, they should be put out to pasture Sawaya, GF. Arch Intern Med, Vol 171, Dec 2011

1

The Clinical Pelvic Exam  Proposed utility in the asymptomatic woman:  STI screening  Cervical cancer screening  Ovarian cancer screening  Detection of benign pelvic pathology  Detection of neoplastic vulvar or vaginal lesions  Early detection of Pelvic Organ Prolapse  Pre-requisite for initiation hormonal contraception

The Data: STI Screening

Data: Cervical Cancer Screening

 Nucleic Acid Amplification Testing (NAAT)  Broadened options for STI screening  First catch urine  Self Collected vaginal swabs

 Many patients prefer self-collected specimens  Self-collection is more cost effective than provider

collection Westhoff CL et al. J of Women's Health, 2011 Chernesky MA et al. Sex Transm Dis, 2005 Blake DR et al. Sex Transm Dis, 2008

Data: Ovarian Cancer Screening

Benign Pathology

 Bimanual exam has very poor sensitivity and specificity for

detecting ovarian cancer  NCI Ovarian cancer screening trial eliminated bimanual exam after finding

that no cancers had been detected with this modality

 Philosophical Question: Do we need to find it?  Fibroids  Benign adnexal masses  Prolapse  Vaginitis  Atrophy

Buys SS et al. Am J Obstet Gynecol 2005 Clark-Pearson DL, N Eng J Med, 2009

2

Data: Benign Pathology  False Positive Rate

What are docs doing? 2008: 63.4 million pelvic exams performed in the US

 2623 healthy, asymptomatic volunteers  Uterus “bulky” or fibroid in 21%  Abnormal adnexa in 1.5%  Half had no adnexal pathology on ultrasound  20% underwent surgery for benign ovarian conditions

 Rates of ovarian cystectomy and hysterectomy twice as high

in US as in UK  BME not routine in Europe

http://www.cdc.gov/nchs/data/ahcd/namcs_summary/namcssum2008.pdf Stormo AR et al. JAMA, Dec 2011 Grover SR. Med J Aust, 1995 Westhoff C. Br J Obstet Gynaecol, 1992

Clinicians who would perform bimanual exam and consider it very important, by vignette

Henderson JT et al. Am J Obstet Gynecol, Feb 2013

Why so many pelvic exams?

Henderson JT et al. Am J Obstet Gynecol, Feb 2013

ACOG’s guidance…. Well-Woman Care  Screening pelvic examination:  Ages 13-20: when indicated by the medical history  Age 21-39: periodic pelvic examination (annual?)  Ages 40-64: annual pelvic exam  Over 65: annual pelvic examination  When a woman's age or other health issues are such that she would

not choose to intervene on conditions detected during the routine examination, it is reasonable to discontinue pelvic exams

Henderson JT et al. Am J Obstet Gynecol, Feb 2013

http://www.acog.org well - woman care : assessments & recommendations, 7/2013

3

Annual Pelvic Exam  The College’s guidelines acknowledge that no current

scientific evidence supports or refutes an annual pelvic exam for an asymptomatic, low-risk patient, instead suggesting that the decision about whether to perform a pelvic examination be a shared decision between health care provider and patient, based on her own individual needs, requests, and preferences.

 Chance favors the prepared mind…  We will only find what our mind is open to  Exam may prompt discussion not initiated by the patient

 However, the College continues to firmly believe in the

clinical value of pelvic examinations…While not evidencebased, the use of pelvic exams is supported by the clinical experiences of gynecologists treating their patients. ACOG Committee Opinion Well-Woman Visit, 2012 ACOG Practice Advisory on Annual Pelvic Exams, 6/30/2014

Clinical Breast Exam

Bump RC. AJOG, Feb 2013

Does Breast Exam enhance cancer detection rates?  8-17% of cancers are missed by mammography  Clinical breast exam improves the sensitivity of cancer

screening compared with imaging alone  94.6% vs 88.6%

 False positive rate is higher among patients screened with

CBE in addition to mammo  12.4% vs. 7.4%

Chiarelli AM et al. J Natl Cancer Inst 2009 Goodson et al. Am J Med, 2010

Breast Cancer Screening, ACOG PB No122, 8/2011

What else do we have to offer?

The Existential Crisis

 Well-woman care is much more than just pap smear  More than breast and pelvic exam

 Preventative Care:     

Are we primary care doctors or not?

Promoting preventative practice Immunizations Recognizing disease risk factors Identifying medical problems Maintaining doctor-patient relationship

 Primary Care?

4

State of Primary Care in the US  In 2010, there were 209,000 practicing PCPs in the U.S  Of the 624,434 physicians in the US, less than one-third are in

primary care  In 2008, Americans made 956 million visits to office-based

physicians  51.3% of those visits were to primary care physicians.1

www.AHRQ.gov National Center for Health Statistics. 2011.

25% of graduating medical students match into primary care residencies

Internal Medicine…PCP?  Among US residents completing Internal Medicine

residency  80% pursue subspecialty fellowship  20% who practice General Internal Medicine  50% become hospitalists

West, CP. JAMA, Dec 2012

The Primary Care Gynecologist

5

http://www.acog.org/About_ACOG/ACOG_Departments/Annual_Womens_Health_Care/Assessments_and_Recommendations

The Annual Exam: If not for Pap smear, then what?

Thank you

 Re-frame the approach: Comprehensive Well-woman Care  Recognize that breast and pelvic exam can be a relatively

small part of this care  Consider our role as primary care providers  Yearly visits still justified

6

Dennis S. Chi, MD, FACOG, FACS Dennis  S.  Chi,  MD,  FACOG,  FACS,  has  served  as  a  faculty  member  on  the  Gynecology  Service,  Department of Surgery, Memorial Sloan‐Kettering Cancer Center, since 1997. He is the Deputy Chief of  the Gynecology Service, Director of the Gynecologic Oncology Fellowship, and Co‐Director of the Pelvic  Reconstruction  Group  at  MSKCC.  His  experience  in  research  has  led  to  numerous  publications  and  international presentations on the surgical management of early, advanced, and recurrent gynecologic  cancers.  The main focus of his research has been evaluating ways to improve the surgical outcomes of  women with advanced and recurrent ovarian cancer.   

ACOG District XII 2014 Annual District Meeting

Disclosure CURRENT MANAGEMENT OF OVARIAN CANCER

This speaker has no conflicts of interest to disclose relative to the contents of this presentation.

Dennis S. Chi, M.D. Gynecology Service, Department of Surgery Memorial Sloan-Kettering Cancer Center New York, New York

Objectives At the end of this presentation, participants should be able to: • Explain the rationale for surgical staging • Illustrate the role of cytoreductive surgery • Summarize the utilization of chemotherapy

Ovarian Cancer • Worldwide:

~225,000 new cases / year (3rd) ~140,000 deaths / year (2nd)

• U.S.:

22,000 new cases / 2011 (2nd) 15,500 deaths / 2011 (1st)

• Advanced stage disease (60-75%) – Long-term survival 25-30%

• Prognostic factors: – Age – Performance Status – FIGO Stage

- Tumor grade - Chemosensitivity - Residual disease

Jemal et al. CA Cancer J Clin. 2011;619:69-90; GLOBOCAN 2008; Cancer Research UK. Seigel et al. CA Cancer J Clin. 2011;61:212-36

Management of Ovarian Cancer

Patterns of Spread of Epithelial Ovarian Cancer

Role of Surgery • • • • • •

Establish diagnosis Comprehensive staging Primary cytoreduction (debulking) Second-look surgery Secondary cytoreduction Palliation

• Direct extension • Lymphatics • Exfoliation of clonogenic cells

1

FIGO Staging of Ovarian Carcinoma Stage

Criteria

I

Tumor confined to the ovaries

II

Extension to other pelvic structures

III

Abdominal or lymph node involvement

IV

Distant metastases

Distribution and Five-Year Survival By FIGO Stage for Ovarian Carcinoma N= 4116

Stage

Distribution

I

27%

Five-Year Survival 78-90%

II

10%

68-79%

III

50%

29-49%

IV

13%

13%

Pecorelli S et al. Int J Gyn Obstet 2003

Results of Repeat Staging in Apparent Stage I and II Ovarian Cancer Initial Stage

No. Patients

Upstaged

IA IB IC IIA IIB IIC Total

37 10 2 4 38 9 100

16% 30% 0% 100% 39% 33% 31%

Young RC et al. JAMA 1983

Results of Complete Surgical Staging in Pts Thought to Have Stage I or II Ovarian Cancer Site of Biopsy

Positive

Para-aortic lymph nodes

12%

Omentum

11%

Pelvic lymph nodes

9%

Random abdominal biopsies

9%

Random pelvic biopsies

9%

Cul-de-sac

6%

Diaphragm

3%

Young RC et al. JAMA 1983

2

Standard Surgical Staging of Apparent Early Stage Ovarian Carcinoma • • • • • • • •

“Generous” vertical incision Multiple cytologic washings Intact tumor removal TAH/BSO (USO in selected cases) Omentectomy Random peritoneal biopsies Biopsy all adhesions and suspicious lesions Pelvic and para-aortic lymph node sampling

Diagnosis of Ovarian Cancer • • • • • •

Requires histopathologic analysis Percutaneous biopsy not recommended Counseling preoperatively Appropriate preoperative consultation Frozen section analysis available Avoid introperative rupture

GOG Surgical Manual

Prognostic Significance of Intraoperative Capsule Rupture (Stage I Ovarian Cancer) Author/Year (Country)

No. Pts

Impact of Intraoperative Rupture

Sevelda/1990 (Austria)

204

No prognostic importance

Sainz/1994 (USA)

79

May worsen prognosis

Sjovall/1994 (Sweden)

394

No negative influence

Ahmed/1996 (UK)

194

Not prognostically significant

Vergote 2001 (Belgium)

1545

Rupture should be avoided HR=1.64

The Safety and Efficacy of Laparoscopic Surgical Staging of Apparent Stage I Ovarian and Fallopian Tube Cancers • Case-control study from 10/00-3/03 • Objective: to compare the safety and efficacy of surgical staging via laparoscopy vs laparotomy • 20 pts underwent laparoscopic staging • 30 pts underwent staging via traditional laparotomy during the same time period Chi DS et al. Am J Obstet Gynecol 2005

Laparoscopic Staging of Ovarian Cancer

Author/Year

Country

No. Pts

Avg Pelvic #LNs

Avg #PALNs

8

-

8.6

14

-

-

8

7.5

8.5 -

Querleu/1994 France Childers/1995

USA

Pomel/1995 Canada Amara/1996

USA

4

-

Mehra/2004

UK

6

-

-

Tozzi/2004

Italy

24

19.4

19.6

Results of Surgical Staging in Clinical Stage I Ovarian and Fallopian Tube Cancer Variable No. pts.

Laparoscopy (mean)

Laparotomy (mean)

Pvalue

20

30

-

BMI

24.6

25.4

NS

# PLN

12.3

14.7

NS

# PAN

6.7

9.2

NS

Omentum

186cm3

347cm3

NS

EBL (ml)

235

367

0.01

LOS (d)

3.1

5.8

0.01

10% upstaged in both groups

3

Robotics Surgical Staging of Clinical Stage I Ovarian Cancer

Conclusions

5/1/07 – 7/31/09 (27 months)

Variable

Laparoscopy (n=22)

Robotic (n=11)

P-value

Median age (years) Median BMI (kg/m2) Converted – N(%)

54 (29-78) 26.2 (19.1-35) 9 (41%)

46 (30-67) 24.8 (17.4-30.3) 1 (9%)

0.21 0.37 ns

Median room time (min) Median operative time (min) Median EBL (cc) Median LOS (days)

300 (246-493) 244 (176-423) 100 (25-190) 2 (1-2)

360 (219-567) 281.5 (174-423) 62.5 (50-100) 1 (1-2)

0.23 0.34 0.006 0.14

13 (6-28) 9 (3-19) 27 (15-38)

13.5 (2-34) 14 (3-21) 29 (12-54)

0.64 0.15 0.34

Median PLN count Median PAN count Median Total LN count

Leitao MM, et al. Unpublished Data 2010

Surgery in Advanced Ovarian Cancer

Diagnosis

Primary Chemotherapy

Laparoscopic Surgical Staging of Apparent Stage I Ovarian and Fallopian Tube Cancers

Remission

Recurrence

Theoretical Benefits of Optimal Cytoreductive Surgery for Advanced Ovarian Carcinoma

• Removal of large bulky tumors with poor blood supply • Improved sensitivity of residual masses to postoperative chemotherapy • Greater likelihood of tumor eradication before chemoresistance develops

• In cases of apparent early adnexal cancer, comprehensive surgical evaluation is necessary to determine the proper stage, treatment, and prognosis • In our preliminary analysis, it appears that pts with apparent stage I ovarian and fallopian tube cancer can safely and adequately undergo laparoscopic or robotic surgical staging • Larger studies and longer followup are Chi DS et al. Am J Obstet Gynecol 2005 required

Surgical Cytoreduction • Also known as “tumor debulking” • Resection of as much visible and palpable tumor as possible • For most solid tumors, not justified • Theoretical and clinical benefits demonstrated for ovarian carcinoma

Gompertzian Model of Tumor Growth • Tumor burden of 3x10E12 is lethal

3.00E+12

• Nearly all rapid proliferation is in the preclinical phase

2.00E+12

• Bulky tumors will respond poorly to chemotherapy

1.00E+12 CELL #

0.00E+00 0

5

10

• Adjuvant therapy is most active

4

Norton Simon Model of Ovarian Cancer Surgery

Cell Number

1.E+12

Chemo

Chemo

Chemo

Clinical Benefits of Optimal Cytoreductive Surgery For Advanced Ovarian Carcinoma

Clinical Detection

1.E+09 1.E+06

Resistant Clones

1.E+03 1.E+00

0

10

20

30

40

50

60

Months

• Improved pt comfort/GI function/nutrition • Better response rate to chemotherapy • Higher percentage of negative secondlook surgeries • Prolonged progression free interval • Improved overall survival

Residual Disease • The maximum diameter of the largest tumor mass remaining after cytoreductive surgery • By convention, measured in cm • Optimal versus suboptimal cytoreduction or debulking refers to the amount of residual disease in relation to a certain cutoff point (e.g., 1.0, 1.5, 2.0, or 3.0 cm)

What is the Optimal Goal of Primary Cytoreductive Surgery?

What is the Optimal Goal of Cytoreduction in Patients with Bulky Stage IIIC Ovarian Carcinoma? • Review of 465 consecutive patients (1/8912/03) • No pts were stage IIIC based solely on lymph node metastasis • 13 factors analyzed for prognostic significance • Multivariate analysis: – Age – Ascites – Residual disease

Pts

Median OS (mo)

Micro

67

106

< 0.5 cm

70

66

0.5 – 1 cm

99

48

1 - 2 cm

53

33

> 2 cm

176

34

Residual Disease

microscopic 2cm

Chi DS et al. Gynecol Oncol 2006 Chi DS et al. Gynecol Oncol 2006; 103: 559.

5

What is the Optimal Goal of Cytoreduction in Patients with Bulky Stage IIIC Ovarian Carcinoma? Conclusions

• Cytoreduction to > 1 cm residual has no benefit on overall survival • There is a survival benefit associated with cytoreduction to < 1 cm residual • Within the gross residual but < 1 cm category, the closer to no gross residual, the longer the median survival Retrospective review of 1895 pts with stage III ovarian carcinoma treated with primary surgery followed by IV platinum/paclitaxel x 6

Chi DS et al. Gynecol Oncol 2006

Primary Cytoreductive Surgery & Response to Chemotherapy Conclusions  Cytoreduction to > 1 cm residual has no benefit on overall survival  There is a survival benefit associated with cytoreduction to < 1 cm residual

• • •

296 pts Stage IIIC-IV, 1998-2004 All started IV platinum-taxane No statistically significant differences between groups for: age, stage IIIC vs IV, histologic subtype, tumor grade, performance status, chemotherapy cycles, consolidation chemotherapy and type of consolidation



Analyzed by residual disease groups:

Residual disease

 Within the gross residual but < 1 cm category, no gross residual is associated with the longest median survival

Patients

Patients achieving cCR

Proportion platinumsensitive at 6 months

Microscopic

64 (22%)

59 (92%)

54 (84%)

1-10 mm

145 (49%)

117 (89%)

98 (68%)

> 10 mm

87 (29%)

49 (56%)

38 (44%)

P < 0.001

P < 0.001

Eisenhauer et al. Gynecol Oncol 2008

Optimal Cytoreduction Rates in Advanced Ovarian Carcinoma with Standard Surgical Techniques

Primary Cytoreduction: Meta-Analysis  Study selection

Author

Year

No. Pts

Smith Wharton Neijt Makar Chi Total

1979 1984 1993 1995 2001

792 395 265 455 282 2189

Optimally Cytoreduced 24% 39% 46% 27% 25% 30%

• Medline database 1989 – 1998 • Stage III-IV ovarian cancer: Surgery + Platinum • “Maximum cytoreduction” = % patients “optimal” • 6,885 patients in 81 patient cohorts ● Mean weighted median survival - 29.0 months ● Multiple linear regression analysis - each 10% increase in maximum cytoreductive surgery was associated with a 5.5% increase in median survival time

Bristow et al. J Clin Oncol 2002; 20:1248.

6

Primary Cytoreduction: Meta-Analysis

Author/Year

No. Pts

Cutoff Maximal Cytoreduction

Maximal Cytoreduction

Chemotherapy Study?

Omura /1989

349

≤ 1 cm

100%

Yes

Piver/1991*

61

≤ 2 cm

79%

No

Gershenson/19 92

116

≤ 2 cm

100%

Yes

Marchetti/1993 *

70

≤ 2 cm

91%

No

Baker/1994 **

136

≤ 2 cm

83%

No

Alberts/1996

546

≤ 2 cm

100%

Yes

10 20 30 40 50 60 70 80 90 100

Meerpohl/1997

158

≤ 2 cm

100%

Yes

Percent Maximum Cytoreductive Surgery

Vallejos/1997

30

< 1 cm

87%

Yes

Eisenkop/1998

163

≤ 1 cm

99%

No

Conclusions  Percent Maximum Cytoreduction  “Expert” vs. less-experienced centers - < 25% maximal cytoreduction: weighted median OS: 22.7 months - > 75% maximal cytoreduction: weighted median OS: 33.9 months - increase of 50%

Weighted Median Survival (months)

40

- Independent determinant of survival

MaxCyto

Studies with ≥ 75% Maximal Cytoreduction Rate in Bristow Meta-Analysis

38 36 34 32 30 28 26 24 22 20 0

Bristow et al. J Clin Oncol 2002; 20:1248.

*studies from SUNY Buffalo, **40% maximal cytoreduction rate for ≤ 1 cm cutoff

I. Primary Cytoreduction 60-

Survival Adv Ovary Cancer MSKCC 1987-2004

“extensive upper abd surgery” * (2001-2004)

50“increased LARs” * (1996-1999)

Weighted Median Survival (months)

40

MaxCyto

38 36 34

“standard surgery” * (1987-1994)

32 30 28 26 24 22 20 0

Conclusion: NACT “not inferior to primary debulking surgery”

10

20

30

40

50

60

70

80

90 100

Chi DS et al. Gynecol Oncol 2009

Percent Maximum Cytoreductive Surgery

7

Aletti GD et al. J Am Coll Surg 2009

Meta-Analysis of IV vs. IP Chemotherapy in Ovarian Cancer • Seven randomized trials have compared the administration of IP chemotherapy vs. IV chemotherapy for first-line treatment of advanced ovarian cancer • On average, IP therapy was associated with a 21.6% decrease in the risk of death from ovarian cancer Cochrane Analysis, Jaaback K, Johnson, N 2006

Harter P et al. Gynecol Oncol 2011

MSKCC Contemporaneous Experience to EORTC/NCIC Trial of PDS vs NACT + IDS (9/98-12/06) All Patients Seen During Study Period 342

All “Eligible” Patients 316

• Identical inclusion criteria for all patients undergoing primary surgery at MSKCC during same time period (9/98-12/06) • Excluded patients with borderline, germ cell, stromal, and advanced CA based solely on nodal metastasis • All pts “eligible” for EORTC trial: 316

Neoadjuvant Chemotherapy 31 (10%)

Extraabdominal Disease 18 (6%)

Extensive abdominal Disease 11 (3.5%)

Poor KPS and/or refused Surgery 26

Primary Surgery 285 (90%)

Advanced Age (> 85 yo) 2 (0.5%)

Optimal Cytoreduction 203 (71%)

Suboptimal Cytoreduction 82 (29%)

Chi DS et al. Gynecol Oncol 2012

8

Progression-Free Survival Both Arms of EORTC NACT Trial vs. MSKCC Primary Cytoreduction

MSKCC (optimals + suboptimals) Median PFS 17 months

Overall Survival Both Arms of EORTC NACT Trial vs MSKCC Primary Cytoreduction

MSKCC (optimals + suboptimals)

MSKCC PFS No gross 24 mos ≤ 1 cm 17 mos > 1 cm 13 mos

Both EORTC arms Median PFS 12 months

Current Management of Ovarian Cancer Summary • In cases of apparent early adnexal cancer, comprehensive surgical staging is essential to determine the patients prognosis and further therapy • In well-trained hands, surgical staging can be performed safely and adequately via laparoscopy (robotically?) • For surgical stage I and II patients, most should be treated with systemic paclitaxel and carboplatin for 3-6 cycles

Current Management of Ovarian Cancer Summary • Using extensive upper abdominal surgical techniques, optimal cytoreduction rates of over 75% can be achieved • Ruling out extraperitoneal disease and minimizing intraperitoneal disease are of paramount importance given the findings of GOG 172 (Armstrong et al, NEJM 2006) and the proven benefits of primary IP chemotherapy for pts with residual < 1 cm • For those with stage IV disease and suboptimal primary cytoreduction, the weekly taxol regimen is preferred by many • Bevacizumab has been shown to improve PFS but not OS and is not considered part of standard of care in the US

Median OS 50 months

MSKCC OS No gross 78 mos ≤ 1 cm 50 mos > 1 cm 36 mos

Both EORTC arms Median OS 30 months

Current Management of Ovarian Cancer Summary • Cytoreductive surgery has no benefit on survival when the diameter of the largest residual tumor nodule measures greater than 1 cm • Extensive surgical resection is warranted in cases that can be cytoreduced to optimal status (< 1 cm residual disease) • Patients who have optimal cytoreduction have five-year survival rates of approximately 50% and even greater if a complete gross resection can be attained

Primary Surgical Management of Ovarian Cancer Summary

• Survival rates with neoadjuvant chemotherapy approaches are identical to those for suboptimal primary cytoreduction (median survival of ≤ 3036 months) • Restrict the use of neoadjuvant chemotherapy to only those most unlikely to undergo optimal surgery or those too medically compromised

9

Acknowledgements • • • • • • • • •

ACOG District XII John Diaz Rick Estape Robert Yelverton Karen Harris Guy Benrubi Colleen Filbert Allison Filbert Shelly Holmstrom

• • • • • • • • •

Richard Barakat Carol Brown Nadeem Abu-Rustum Yukio Sonoda Doug Levine Mario Leitao Ginger Gardner Elizabeth Jewell Oliver Zivanovic

THANK YOU!!!

10

Elissa Meites, MD, MPH     Dr. Elissa Meites is a medical epidemiologist with the Division of STD Prevention in the National Center for HIV,  Viral Hepatitis, STD, and TB Prevention at the Centers for Disease Control and Prevention. Dr. Meites has  authored or coauthored >35 scientific manuscripts, MMWR reports, and book chapters on infectious disease  epidemiology; her areas of expertise include human papillomavirus and trichomoniasis. She contributes to  national and international evidence‐based policymaking as an HPV Vaccine workgroup member for the Advisory  Committee on Immunization Practices, and has received various awards for leading and participating in local,  regional, and international outbreak investigations and emergency responses. She joined CDC in 2008 as an  Epidemic Intelligence Service officer with the Division of Healthcare Quality Promotion. Dr. Meites holds an MD  from the Stanford University School of Medicine and an MPH from the University of California at Berkeley, and  completed her residency in Family and Community Medicine at the University of California at San Francisco. She  is a Fellow of the American Academy of Family Physicians and a commissioned officer with the United States  Public Health Service.  

Disclosures 

None (no financial or other conflicts of interest)



HPV Pathogenesis

HPV and Men

Elissa Meites, MD, MPH Medical Epidemiologist ACOG District XII Annual Meeting August 17, 2014

NationalCenterforHIV/AIDS,ViralHepatitis,STD,and TB Prevention Division ofSTD Prevention

Learning objectives 

Outline

1. Discuss natural history and epidemiology of HPV infection and HPV-associated disease  Virtually all sexually active people have HPV at some point  HPV infection commonly clears without intervention, but persistent infection can cause genital warts and cancers (cervical, anal, oropharyngeal) in women and men

 Natural history  Transmission 

 HPV infection  HPV-associated diseases 



HPV Epidemiology

HPV Prevention  HPV vaccine recommendations  Screening considerations

2. Explain national HPV vaccine recommendations  HPV vaccine is recommended for U.S. males and females based on age (through 21 or 26 years)

Human papillomaviruses (HPV) 

Family of non-enveloped DNA viruses  Highly tissue-tropic  >120 types with ~40 mucosal types



“High risk” oncogenic types



“Low risk” non-oncogenic types

 Can cause cancers HPV natural history and transmission

 Can cause warts

PATHOGENESIS

1

HPV infection and disease 

Spectrum of HPV disease in cells

HPV is the most common sexually transmitted infection

Low - grade disease

High- grade disease

 Prevalence of 37 sexually transmitted HPV types in cervicovaginal swabs from U.S. females age 14−59 in 2003−06 was 42.5% 

Most HPV infections are asymptomatic  ~70% of new infections clear within one year  ~90% of new infections clear within two years



However, some HPV infections persist for longer



Persistent HPV infection may progress to disease

 High risk types are more persistent than low risk types Morphologic Continuum

 Disease can present many years after initial infection Hariri, J Infect Dis 2011 Molano, Am J Epidemiol 2003

Winer, Am J Epidemiol 2003 Franco, JID 1999

Ho, NEJM 1998 Moscicki, J Pediatr 1998

Diseases associated with HPV 

       

HPV transmission

Oncogenic types (16, 18, others)



Cervical cancers Anal cancers Oropharyngeal cancers Vaginal cancers Vulvar cancers Penile cancers High grade intraepithelial neoplasias



Virtually all sexually active adults get HPV at some point Any type of mucosa-mucosa contact  Vaginal sex  Anal sex  Oral sex



Soon after first sex  Most consistent risk factor for HPV is higher number of sex partners

Non-oncogenic types (6, 11, others)  Anogenital warts  Recurrent respiratory papillomatosis (RRP)  Low grade intraepithelial neoplasias



Prevention  Vaccine (ideally given before exposure)  Consistent and correct use of condom barriers  Not having sex

Nicolau 2005, Myers 2000, Koutsky 1997, Castellsagué 1997

Percentage of females and males who have had vaginal sex, by age — United States, 2006– 2008 100

Females

Males

90

84

80

74

Percent

70

59

60 50

44

40 30 20 10

Cumulative incidence of genital HPV infection among sexually active female college students

34 23

78

67

56

44

32

21

0 15

16

National Survey of Family Growth (NSFG)

17

Age (years)

18

19

20 Winer, Am J Epidemiol, 2003;157

2

Cumulative incidence of HPV infection

Cumulative incidence of genital HPV infection among sexually active male college students

Concordance among heterosexual couples

1



0.9 0.8 0.7 0.6 0.5 0.4

 31 (35%) had negative concordance  21 (24%) had type-specific positive concordance

0.3 0.2 0.1

95% C I

Failure Function

0 0

Partridge, JID 2007

4

8

12

16

20

24

Months since enrollment

59% of 88 heterosexual couples had positive or negative concordance:

Nyitray. Genital Human Papillomavirus (HPV) Concordance in Heterosexual Couples. JID 2012

Genital HPV infection in men 

Risk factors for oncogenic HPV infection  High number of lifetime female sexual partners • Hazard ratio 2.4 (95%CI:1.8–4.2) for ≥50 partners vs ≤1 partner

 High number of male anal-sexual partners • Hazard ratio 2.6 (95%CI:1.5–4.5) for ≥ 3 male partners vs none 

 7.5 months (95%CI:6.8–8.6) for any HPV  12.2 months (95%CI:7.2–18.2) for HPV 16

HPV infection

EPIDEMIOLOGY

Median duration of genital HPV infection

 

Oncogenic HPV types persist longer Older men clear HPV more quickly than younger men

Source: Giuliano, Incidence and clearance of genital human papillomavirus infection in men (HIM): a cohort study, Lancet 2011

Incidence of genital HPV infection in men

Source: Giuliano, Incidence and clearance of genital human papillomavirus infection in men (HIM): a cohort study, Lancet 2011

Clearance of genital HPV infection in men

Source: Giuliano, Incidence and clearance of genital human papillomavirus infection in men (HIM): a cohort study, Lancet 2011

3

Anal HPV infection in men 

 Risk factors for infection included:  Receptive anal intercourse within 6 months (OR 2.0, p5 anal sex partners within 6 months (OR 1.5, p