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 Guidelinesreduce 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
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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 endotheliumarterioles>veinsdecr SVR Elicits a reflex stimulation of HR (baroreceptor reflex) and CO May increase plasma reninfluid retentionusually Rx’d with Bblocker and diuretic Bioavailability = 26-55% Half-Life = 2-4 hours Liver metabolismrenal excretion
LABETALOL
Mixed alpha/beta adrenergic antagonist – Block Beta:Alpha 3:1 receptorsdecr SVR Oral 100mg bid1200mg 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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
7
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
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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
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The Future of ACOG is EXACTLY WHAT WE MAKE OF IT You cannot create the future while clinging to the past
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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
Prevention of Medical Errors / 2
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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1
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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2
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.
Prevention of Medical Errors / 15
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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3
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
Prevention of Medical Errors / 21
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
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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
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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
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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
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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
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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
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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
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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
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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
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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%
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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]
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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.
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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
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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
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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