Timing of Induction of Labor: Financial Relationships Myths, Facts, and • No financial disclosures related to this talk Misunderstandings? • Medical Advisor to: • Celmatix • Mindchild Aaron B. Caughey MD, PhD Professor and Chair • Bob’s Red Mill Department of Obstetrics and Gynecology Oregon Health & Science University [email protected]

Outline Definitions

• Gestational age at term • Early Term 37 0/7 to 38 6/7 • ‘Elective’ IOL varying GA • Full Term 39 0/7 to 40 6/7 • Early Term • Late Term 41 0/7 to 41 6/7 • Late Term • Postterm 42 0/7 and beyond • Full Term • Induction of labor • Outcomes • Cesarean

Outcomes by Gestational Age Neonatal Morbidity by GA

Neonatal Outcomes

37 38 39 40 41 weeks weeks weeks weeks weeks

5-minute Apgar <7 1.01 % 0.69 % 0.61 % 0.70 % 0.93 % 5-minute Apgar <4 0.19 % 0.13 % 0.11 % 0.12 % 0.14 % Meconium stained 2.27 % 3.24 % 5.20 % 7.39 % 10.33 % amniotic fluid

Meconium aspiration 0.07 % 0.08 % 0.12 % 0.19 % 0.27 % Hyaline membrane 0.45 % 0.19 % 0.14 % 0.14 % 0.18 % dz Mech vent >30min 0.57 % 0.32 % 0.28 % 0.29 % 0.38 %

Caughey AB, Musci TJ. Obstet Gynecol, 2004;103:57-62 Cheng YW, et al. AJOG, 2008 IUFD/Infant Death Rates - Compare Elective CDs: NICU by GA

Tita A et al. NEJM, 2009 Rosenstein MR, et al. Obstet Gynecol, 2012

Elective IOL – What?

• Common Medical Indications for IOL • Preeclampsia / Gest HTN • Diabetes Mellitus (A1GDM?) • Postterm (41 wks vs. 42 wks) • Intrauterine Growth Restriction • Nonreassuring fetal testing

Elective IOL – What? Elective IOL – Why does it matter? • Not a medical indication for IOL • Impending macrosomia • Indicated IOL • Increased risk for developing: • Preeclampsia • Risks and benefits have been considered • IUGR (e.g. EFW 19%ile) • IOL vs. Expectant Mgmt • Favorable cervix • Elective IOL • Risks and benefits should be considered • IOL vs. Expectant Mgmt Elective IOL Elective IOL – early term

Pro Con Pro Con ? neonatal comps Ĺ cesareans Ĺ maternal prefs Ĺ neonatal comps Ĺ md prefs Ĺ maternal prefs Ĺ maternal comps ? cesareans Ĺ md prefs Ĺ costs Ĺ maternal comps Ĺ costs

Elective IOL prior to 39 weeks of gestation is not consistent with the standard of care or ACOG and should only be offered in experimental protocols with written informed consent

IOL – Early Term Elective IOL – late term

• IOL – When to deliver? Pro Con • Preeclampsia / Gest Htn Ļ neonatal comps Ĺ cesareans • Chronic Htn Ĺ maternal comps • Diabetes Mellitus (A1GDM?) Ĺ maternal prefs Ĺ costs • Intrauterine Growth Restriction Ĺ md prefs • 10%ile, 5%ile, 3%ile, changes on Doppler • Nonreassuring fetal testing • Cholestasis • Previa / accreta • Twins (Di-di vs. Mo-di)

Elective IOL – late term Elective IOL - CS

• Does IOL increase cesarean delivery? Pro Con Ļ neonatal comps Ĺ cesareans Ĺ maternal prefs Ĺ maternal comps Ĺ md prefs Ĺ costs • Cohort and case-control data • IOL increases cesareans • Prospective RCTs • 41 weeks GA – decreases cesareans • <41 weeks GA – ? Induction of Labor Induction of Labor

• Comparison of IOL vs. ANT • IOL vs. Expt Mgmt 41 wks and beyond

• (Hannah et al., NEJM, 1992 • Sanchez-Ramos et al, OB Gyn, 2003 • Meta-analysis, 16 prospective RCTs • 1701 IOL @ 41 wks vs. 1706 ANT @ 41 wks

• C/S higher in ANT group (24.5% vs. 21.2%) • Mode of delivery • IOL Expt Mgmt OR 95% CI • C/S for FD higher as well (8.3 % vs. 5.7%) • CS - 20.1% CS – 22.0% 0.78 – 0.99 • Mec – 22% Mec – 27% 0.49 – 0.88 • Higher rate of meconium in ANT group • PMR – 0.09% PMR – 0.33% 0.14 – 1.18 • No difference noted in neonatal morbidity PMR = perinatal mortality rate

Elective IOL at 41 wks or less Induction of Labor - CS

• Retrospective studies - more CS with IOL • Prospective studies – fewer CS or no diff • What are the groups being compared? • IOL at 39 weeks vs. Spont labor at 39 weeks • However, in RCT: • IOL at 39 weeks GA vs. • Patients beyond 39 weeks GA

Caughey AB, et al. Ann Int Med, 2009;151:252-63.

Induction of Labor < 41 wks GA Elective IOL - CS Elective IOL vs. Expt. Mgmt - Cesarean Delivery IOL 38 39 40 41 42

No IOL 38 39 40 41 42

A. Comparison by week of gestation

IOL 38 No IOL 38 Æ 39 Æ 40 Æ 41 Æ 42

B. Comparison of IOL and Expectant Management Caughey et al, AJOG 2006;195:700-5 Darney B, et al. OBG. 2013 IOL at term IOL at term • ARRIVE Trial • ARRIVE Trial

• 6106 women randomized to IOL vs. Expt Mgmt. at 39 to 39 4/7 wks GA

IOL Expt Mgmt IOL Expt Mgmt

Grobman W, et al., NEJM 2018 Grobman W, et al. AJOG, NEJM 2018

Elective IOL – full term Elective IOL - CS

Pro Con • Prospective RCT at 41 wks – lower CS ? neonatal comps ? cesareans • Prospective RCTs < 41 wks – lower CS Ĺ maternal prefs Ĺ maternal comps • Multiple retrospective studies – higher CS Ĺ md prefs Ĺ costs • Appropriate retrospective studies – lower/no diff in CS

• Research protocols vs. Actual practice

IOL - patience Is 39 the new 41?

• Why Not • The proportion impacted is dramatically different • The risk from 39 to 40 differs from 41 to 42 • ARRIVE is great, but we have many more 41 RCTs • Need to understand global clinical/economic impact • Maybe • Cesarean data is convincing, at least in right settings • Also prevents hypertensive complications • Might be cost effective Summary – Should Every Woman Be Induced at 39 weeks? Thank You • Early Term (37-38 wks GA) • Currently, a bad idea without indication • 41 wks GA (some call this postterm) • ACOG recommends • Improved outcomes • Full Term (39-40 wks GA) • Not a violation of SOC • Evidence is evolving • Depends on environment • Economic Impact

Elective IOL - CS

Elective IOL vs. Expt. Mgmt - Perinatal Mortality

Stock S. BMJ. May, 2012

Case #3 Back to Case #3

• 27 yo G1P0 at 39 1/7 requesting IOL • 27 yo G1P0 at 39 1/7 requesting IOL • Unfavorable cervix w an unfavorable cervix.

• Expt Mgmt & ANT vs. IOL • Plan: • Neonatal outcomes • A) IOL now • Maternal outcomes • Cesarean Delivery • B) IOL at 40 wks • C) IOL at 41 wks • What are the R/B/A • D) IOL at 42 wks Elective IOL – Hard Stop Elective IOL – Hard Stop

Astoria Seaside St Helens Hermiston

Pendleton Hillsboro Gresham The Dalles Enterprise Tillamook Beaverton Cape Lookout Portland La Grande • Why? Condon Regional Hub McMinnville Silverton Satellite Keizer • Right thing to do medically. Salem Baker City Lincoln City Albany Madras

Corvallis • IOL costly John Day Prineville Canyon City 5 Redmond Eugene Ontario • Need to do geographically Springfield Bend Florence Vale

Reedsport • Facilitates providers to “just say no” Burns North Bend Coos Bay Roseburg

Jordan Valley Port Orford

Grants Pass Bly Medford Ashland Brookings Klamath Falls Lakeview

MILES 020406080

Prevention of Early Term Births Prevention of <39 weeks

• HCA - Clark S, et al. – 2010

• Three approaches

• Hard stop – not allowed

• Soft Stop – MDs agreed not to do

• Education

Clark et al, Am J Obstet Gynecol, 2010

Elective IOL – Hard Stop Elective IOL – Hard Stop

Term births at 37 or 38 weeks’ gestation

Ehrenthal et al, Obstet Gynecol, 2011 Ehrenthal et al, Obstet Gynecol, 2011 Elective IOL – Hard Stop Elective IOL – Hard Stop

Ehrenthal et al, Obstet Gynecol, 2011 Ehrenthal et al, Obstet Gynecol, 2011

Case #3 – What are R&B? IOL for Macrosomia

• 27 yo G1P0 at 39 1/7 requesting IOL • LGA

• Based on past evidence: • IOL at 40 weeks GA as compared to ANT • No difference in cesarean rate • No difference in neonatal outcomes

Cheng et al, BJOG, 2012

IOL for Macrosomia

Cheng et al, BJOG, 2012 Case Presentations Case #1

• 1 – 32 yo G3P2 at 38 0/7 requesting IOL • 32 yo G3P2 at 38 0/7 requesting IOL • Normal Pregnancy • Normal pregnancy

• 2 - 34 yo G2P1 at 41 2/7 declining IOL • Elective IOL prior to 39 weeks of • Normal ANT gestation is not consistent with the standard of care or ACOG and should only be offered in experimental • 3 - 27 yo G1P0 at 39 1/7 requesting IOL protocols with written informed • Unfavorable cervix consent

Elective IOL – Hard Stop Case #2

Hospitals take 'hard stop' on • 34 yo G2P1 at 41 2/7 declining IOL early elective C-sections, inductions • Normal ANT

Oregon is the latest state where some hospitals are refusing to do the procedures before 39 weeks • Expt Mgmt & ANT vs. IOL of pregnancy • Neonatal outcomes • Maternal outcomes • Cesarean Delivery

• What is the pt’s understanding of R/B/A

Induction of Labor Back to Case #2

• Even w/ unfavorable cvx, @ 41 wks IOL: • 34 yo G2P1 at 41 2/7 declining IOL • Biggest concern is that her pregnancies are • Lower cesarean delivery rate supposed to go longer • Lower meconium-stained fluid • Another concern is labor pain similar to first • Lower perinatal mortality rate (small diff) IOL

• Plan: • Extensive counseling re: R&B • Strip membranes • ANTC at 41 4/7 – strip again • Plan IOL at 42 0/7 IOL < 41 wks GA Questions? Contactme

• Cochrane DB – Gülmezoglu AM et al, 2006 OHSUPhysicianAdvice&ReferralService • IOL < 41 weeks had lower CS rate •503Ͳ494Ͳ4567 •800Ͳ245Ͳ6478(tollͲfree) • RR 0.58; 95% CI 0.34 to 0.99 Financial Disclosures

• None

NW Update Induction of Labor

DATE: November 14, 2019 Amy C. Hermesch, MD, PhD 2

Outline Choosing a quality project

• IOL as a Quality Project • Externally mandated measures/required reporting? • Guideline development • High volume of patients impacted? • Limited evidence review • High cost of disease process or potential for significant cost reduction? • Summary • Variability in practice pattern? • Quality of patient safety concern? • Potential for improved patient or provider satisfaction? • Is there evidence to guide practice?

3 4

OregonMaternalDataCenter(OMDC) Step1:FacilitatedGuidelineDevelopment

OHSU Office of Clinical Integration Identify topic for guideline and Evidence-Based Practice development

Draft guideline, and Form interprofessional establish outcome • Promoting best practice and reducing guideline content team measures undesirable practice variation. Guideline • Supports clinical decision making Development Present appraised • Develops infrastructure that supports delivery findings to content expert Process Determine guideline scope team and develop (PICOs, inclusion & practice exclusion criteria) of value based care, shifting focus from volume recommendations of services delivered to the patient-centered outcomes achieved. Critically appraise Search existing evidence using guidelines and GRADE criteria literature

7

IOL Guideline Content/Scope Determined by Content Expert Team:

• Outcomes: – Efficacy – Length of time from start of IOL to delivery – Maternal outcomes including CD rate – Neonatal outcomes • Guideline Content Overview: – Pharmacologic, non-pharmacologic (membrane sweeping, breast stim, etc), mechanical and combination methods. Dosing? Route? – Setting of cervical ripening – Optimal oxytocin protocol after ripening – Optimal route and dose of nutrition and hydration during IOL – What are patients views and experiences during IOL? – What are the effects of staffing models during IOL? – Early vs late administration of epidural anesthesia?

10 – When is cesarean delivery for failed IOL indicated?

Step1:FacilitatedGuidelineDevelopment

Identify topic for Existing National and Local guideline development Guidelines

Draft guideline, and Form interprofessional establish outcome guideline content team measures Guideline Development Present appraised findings to content expert Process Determine guideline scope team and develop (PICOs, inclusion & practice exclusion criteria) recommendations

Critically appraise Search existing evidence using guidelines and GRADE criteria literature

12 GRADE (Grading of Recommendations Assessment, Development and Evaluation): common, sensible and transparent approach to grading quality (or certainty) of evidence and strength of recommendations. Many international organizations have provided input into the development of the GRADE approach which is now considered the standard in guideline development.

Step1:FacilitatedGuidelineDevelopment

Identify topic for guideline development APPRAISE ADAPT APPLY Draft guideline, and Form interprofessional establish outcome guideline content team measures National guidelines & Site-Specific Clinical Decision primary research studies Guideline Support Tools • Clinical calculators Clinical practice • Order sets & smart sets Development recommendations* Present appraised • Policies & protocols findings to content expert Process Determine guideline scope *Developedbymultidisciplinaryclinicalcontent • Patient education material team and develop Local data, expertteamwithpatient/caregiverrepresentation (PICOs, inclusion & • Recommendations for clinical practice exclusion criteria) patient values/preferences, recommendations clinical expertise services

Critically appraise Search existing evidence using guidelines and GRADE criteria literature

Cervical Ripening

• The “sour apple” of IOL • Pharmacologic, mechanical, alternative and combination methods. • Setting? PGE1 vs PGE2? Which route? Which dose?

17 18 19 20

Cervical ripening

• Cost – Misoprostol (PGE1, Cytotec): $0.50 per 100 mcg tablet – Dinoprostone (PGE2, Cervidil): $353 per insert • Compared to PGE2, misoprostol is associated with: – Less common oxytocin augmentation – Less epidural analgesia use – Higher vaginal delivery rate within 24 hrs – Some studies show reduced risk of CD, some show no difference – Berghella V. Obstetric Evidence Based Guidelines, 3rd Edition • Combination methods (misoprostol + foley) – Shorter mean duration from admit to delivery – Al-Ibraheemi et al. Obstet Gynecol 2018. Jan; 131 (1): 23-29. – Carbone JF et al. Obstet Gynecology 2013. Feb 121: 247-52. Suidan etal.AmJ.Perinatol 2015;32:187Ͳ192. 21

23 24 Oxytocin Infusion

• ACOG Practice Bulletin No. 107: Induction of Labor. 2009 Aug; 114(2 Pt 1): 386-97. – Low or high dose oxytocin regimens are appropriate for women in whom IOL is indicated.

• Budden, A., L.J.Y. Chen, and A. Henry, High-dose versus low-dose oxytocin infusion regimens for induction of labour at term. Cochrane Database of Systematic Reviews, 2014(10): p. CD009701. – 8 trials – 2023 women – No difference in CD rates. Higher rates of “hyperstimulation.” No difference in maternal or neonatal outcomes. • Zhang, J., et al., Oxytocin regimen for labor augmentation, labor progression, and perinatal outcomes. Obstet Gynecol, 2011. 118(2 Pt 1): p. 249-56. – Secondary analysis Consortium of Safe Labor – 15,054 women, six hospitals – Starting 4 mu/min and increment 4 mu/min associated with shorter duration of 1st stage (compared with lower dose regimens) – No difference in CD rate or perinatal outcomes

25 26

Hydration Hydration

• Ehsanipoor, R.M., et al., Intravenous fluid rate for reduction of cesarean delivery rate in • Bottom Line: Hydration is important. Volume and type of nulliparous women: a systematic review and meta-analysis. [Review]. 2017. 1(7): p. 804-811. – 7 trials fluid matter. – 1215 women – Women who received IV fluids at 250 cc/hr (vs 125 cc/hr) had significantly shorter length of labor, • PO vs IV lower CD rates and no difference in pulmonary edema • Fong et al, A randomized, double-blinded, controlled trial of the effects of fluid rate and/or presence of • Barriers to adequate hydration dextrose in IV fluids on the labor course of nulliparas. AJOG. 2017 Aug;217(2):208. – Prospective RCT – Nausea or frequent vomiting – 274 women, spontaneous labor. – Comparison: NS 250 cc/hr vs D5NS 250 cc/hr vs D5NS 125 cc/hr – Availability of hydration/nutrition options in hospital – No difference in length of labor or CD rates – Maternal exhaustion • Pare et al, Reduction of total labor length through the addition of parenteral dextrose solution in IOL in nulliparous: results of DEXTRANS prospective randomized controlled trial. AJOG. 2017 May; 216 (5):508. – Long induction of labor – Prospective RCT – 193 women, induction of labor – High risk aspiration, needing emergent CD – Comparison: NS 250 cc/hr vs D5NS 250 cc/hr (started with oxytocin) – Length of labor significantly shorter with D5NS 250 cc/hr (median 76 min), no difference in – Labor is distracting! Cannot rely on patients feeling neonatal or maternal outcomes. “thirsty.”

27 28

Conclusions

• Misoprostol , combination methods best choice • Oxytocin regimen required to achieve adequate contractions may need to be individualized. Need options available to clinicians. • Caughey, A.B., et al., Safe prevention of the primary cesarean delivery. • Hydration is important. Am J Obstet Gynecol, 2014. 210(3): p. 179-93. • Rouse, D.J., et al., Failed labor induction: toward an objective diagnosis. • Use standardized definition for failed IOL. Obstet Gynecol, 2011. 117(2 Pt 1): p. 267-72. • Grobman, W.A., et al., Defining failed induction of labor. American Journal of Obstetrics & Gynecology, 2018. 218(1): p. 122.e1-122.e8.

29 30 https://oregonperinatalcollaborative.org/initiative/iol/

APPRAISE ADAPT APPLY

National guidelines & Site-Specific Clinical Decision primary research studies Support Tools

• Clinical calculators Clinical practice • Order sets & smart sets recommendations* • Policies & protocols *Developedbymultidisciplinaryclinicalcontent • Patient education material Local data, expertteamwithpatient/caregiverrepresentation • Recommendations for clinical patient values/preferences, clinical expertise services

Yourinstitution!

Cervical Ripening

• Chen, W., et al., A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour. [Review]. 2016. 1(3): p. 346-54. • Lin, M.G., et al., Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. 2005. 1(3): p. 593- 601. • Dallenbach, P., et al., Oral misoprostol or vaginal dinoprostone for labor induction: a randomized controlled trial. 2003. 1(1): p. 162-7. • Colon, I., et al., Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol. 2005. 1(3): p. 747-52. • Fisher, S.A., V.P. Mackenzie, and G.A. Davies, Oral versus vaginal misoprostol for induction of labor: a double-blind randomized controlled trial. 2001. 1(4): p. 906-10. 33 34

Cervical Ripening: What makes a good quality Alternative Methods project? • Boulvain, M., C. Stan, and O. Irion, Membrane sweeping • Clinically relevant outcome measures for induction of labour. Cochrane Database of Systematic – Cesarean Delivery Rate Reviews, 2005(1): p. CD000451. – Chorioamnionitis – 19 RCTs, 2389 women – Patient Satisfaction – Membrane sweeping versus expectant managment – Increased likelihood of spontaneous labor in 48 hrs – Neonatal Outcomes – NNTT 8 women – Length of labor

35 36 What makes a good quality Example IOL Guideline project? • Variability in practice patterns – Cervical ripening • Mechanical and pharmacologic options • Different doses • Different routes of administration – Oxytocin • Management in labor • Different titration regiments – Other management strategies • IV fluids: how much (if any) what type • Continuous labor support – Definition of failed induction? • When to stop….

37 38

Induction of labor: Evidence-based changes

• Change from buccal to oral misoprostol • Cervidil taken off formulary • Higher dose oxytocin protocol available • Oxytocin checklist

39

Speed Dating….. • Which outcomes do you currently track related to IOL? • Very briefly describe your hospitals primary cervical ripening method (dose and route) and oxytocin protocol. • How does your institution assess hydration status for actively laboring women? What type of IV fluids are used? NS? LR? D5NS or D5LR? What type of PO hydration options are easily available to women on your labor unit? • Have you made any recent changes to your IOL protocol? Why? • What is something your institutions does really well? Why? • What is something you would like to see improve at your institution? • What do you need to support your hospital to improve outcomes of women who undergo IOL?

42 Can misoprostol be used for IUGR, Oxytocin Utilization oligohydramnios and post-dates pregnancies? • Obesity is associated with higher oxytocin requirement • Prospective and observation data suggest no difference in cesarean delivery rates or neonatal • Higher volume of distribution, dilutional effect outcomes between misoprostol and Cervidil: • Physiologic mechanisms may mediate response • Oligohydramnios: – Kawakita et al. Am J Perinatol 2017. Jan 34 (2): 204-210. • IUGR, post-dates pregnancy: – Rozenberg P et al. 2004 Jul; 191 (1): 247-53. *RCT – Foeller ME et al. Am J Perinatol. 2015. Dec 32/14): 1311-7. – Rossi RM et al. J Mat Fet Neo Med. 2018 May 27:1-6.

43 44 CarlsonNSelal.Reprod Biol Endocrinol.2015.

III. Oxytocin Dosing Oxytocin Utilization 1. Low Dose Protocol: Patients being induced or augmented without the indications below for protocol 2 • Generally, one oxytocin protocol per institution a) Starting rate: 1-2 mu/min b) Rate of increase: Increase by 2 mu/min every 30 minutes until target contraction – Starting dose, interval dose, maximum dose pattern is reached c) 20 mu/min unless patient is re-evaluated by the by the provider and an order to • exceed is given Should we consider a more patient specific d) Maximum is 40 mu/min approach? e) Smaller more frequent incremental doses may be considered • Area needing high quality research: Which 2. Intermediate Dose Protocol: Patients with current magnesium sulfate infusion, BMI> 35, chorio, or provider discretion oxytocin regiment is best for which patient? a) Starting rate: 4 mu/min b) Rate of increase: Go up 4 mu/min every 30 minutes until target contraction pattern is – Low CD rates, low chorioamnionitis rates, reached c) 20 mu/min unless patient is re-evaluated by the by the provider and an order to optimal time to delivery. exceed is given d) Absolute maximum is 40 mu/min Obstet Gynecol. 2011 Aug;118(2 Pt 1):249-56. 45 46 doi: 10.1097/AOG.0b013e3182220192. Disclosures

• No conflicts

Oxytocin Research Overview: past, present & future discovery

November **, 2019 - Elise Erickson PhD, CNM 2

Overview Physiology and Pharmacology

• Briefly review physiology • Oxytocin system variation/ regulation • Oxytocin discovery on the horizon

3 4

Hypothalamic Neuroendocrine Peptide Endogenous/Exogenous Oxytocin

Paraventricular nuclei Anterior (6 cell types) Posterior (axon terminals) Infundibulum Supraoptic Hypophyseal Portal Circulation nuclei

Present Use Sir Henry Dale Vincent du Vigneaud • 1953: Synthesized • ~25% induced • 1906: pituitary peptide sequence, • 30-57% (?) augmented extracts structure •AMTSL •2nd trimester termination/ • 1911: clinical use • 1955: Nobel prize miscarriage management PosteriorPituitary • First peptide ever synthesized

Oxytocin/Vasopressin

5 1906 1911 1955 2019

This Photo by Unknown Author is licensed under CC BY-SA Oxytocin / OXTR- structure OxytocinReceptor(OXTR)Function

Gimpl, G., & Fahrenholz, F. (2001).

Bell,Erickson,Carter(2014)JournalofMidwiferyandWomen’sHealth

Where are oxytocin Peripheral oxytocin action receptors found ? • Uterine muscle contraction • • Kidney/Adrenal Bone • Myoepithelium of breast—milk ejection • • Blood vessels Ovary • Prostaglandin production (decidua of placenta) • • Heart Testicles • Decreased heart rate, blood pressure, temperature • • Platelets Prostate • Decreased cortisol • • Breast Smooth muscle intestine • Suppression pro-inflammatory cytokines • • Myometrium Cancer cells • Increased glucose uptake & insulin secretion • • Placenta Adipose cells • Cell growth (anti-proliferative) • Inhibits growth of adipose cells Yang,H.ͲP., Wang,L.,Han,L.,&Wang,S.C.(2013).NonsocialFunctionsofHypothalamicOxytocin.ISRNNeuroscience. JapundzicͲZigon,N.(2013).VasopressinandOxytocininControloftheCardiovascularSystem.CurrentNeuropharmacology. Yang,H.ͲP., Wang,L.,Han,L.,&Wang,S.C.(2013).Nonsocial 9 10 FunctionsofHypothalamicOxytocin.ISRNNeuroscience.

Evolution of oxytocin • HPA (CRH->Cortisol) Flockingbehavior,pair bonding,vocalization Widerangeofsocial • Dopaminergic pathways (limbic/cortex) behavior:lactation& uterinecontraction • Serotonin neurons Diureticlikefunction

• Vagus nerve (afferent & efferent) Vocalization,socialand sexualandaggression

Memoryprocessing

Learning& Vocalacousticcircuitry reproduction

Gutmotility,eggͲlaying Osmoregulation

Feldman,R.,Monakhov, M.,Pratt,M.,&Ebstein,R. P.(2016).Oxytocin PathwayGenes: EvolutionaryAncient SystemImpactingon OXT/AVP:600millionyearoldsharedgene HumanAffiliation,Sociality, andPsychopathology. Neumann,I.D.(2007).Stimuliandconsequencesofdendriticreleaseofoxytocin BiologicalPsychiatry. 11 withinthebrain.BiochemicalSocietyTransactions,35(Pt5),1252–1257. 12 Howdoes endogenous Regulation and Variation oxytocin functionvary between individuals? Anddoesitmakeadifference duringtheperinatalperiod?

13

Knockout Mice OXT/OXTR variation in human Isoxytocinnecessaryforbirth? perinatal experience?

• When labor starts? • How long labor lasts? • Response to exogenous oxytocin during or after labor? • Lactation variation? • Neurotransmitter Pro-social OXT: Mood/ Parenting Behaviors? Takayanagi,Y.,Yoshida,M.,Bielsky,I.F.,Ross,H.E.,Kawamata,M.,Onaka,T.,etal.(2005). Pervasivesocialdeficits,butnormalparturition,inoxytocinreceptorͲdeficientmice. 15 ProceedingsoftheNationalAcademyofSciences,102(44),16096–16101.

Prostaglandin&OxytocinKnockouts

4 cases 4 had spontaneous labor 2 needed oxytocin augmentation in active phase Yoshida,M.,Takayanagi,Y.,IchinoͲyamashita,A.,Sato,K.,Sugimoto,Y.,Kimura,T.,…Online,F.(2019). Functionalhierarchyofuterotonics requiredforsuccessfulparturitioninmice.Endocrinology. 2 had Cesarean, 1 had instrument assisted birth 4 had PPH (one delayed PPH) 4 had no milk production Pharmacokinetics of OXT/OXTR Peptide • Half life • *Degradation

• Onset of action within 3 to 5 minutes

• Half-life studies: 3-6 minutes vs. 10 to 15 minutes (inblood,longerinCSF/brain)

“…theneedtoensuresuccessfulpregnancylikely • Steady state 30 to 60 minutes producedaredundancyofpathwaystoensurereliable uterineemptyingandexpulsionofthefetus.” • Degraded/inactivated by “oxytocinase” • Zinc-dependent aminopeptidase • PLAP (placental leucine aminopeptidase) 20

Exogenous oxytocin No Downregulation labor Desensitization OXTRmRNAlevel OXTbindingassay Receptor Pharmacology Spontaneouslabor

60x less

HOURSINLABOR Durationofoxt Inducedlabor Receptor • Upregulation (gestational age, hormone) 300x less • Desensitization • Degradation (via internalization) Phaneuf,S.,etal(2000).ReproductionandFertility Maintenancedosemu/min • Down-regulation 21 22

Pretreatment2hours Physiologicsaltsolution

CONTROL

Increasingtestdoseconcentration Oxytocin & Obesity

Lowdose • Lower levels of oxytocin in circulation • Lower levels post-menopause Æ Estrogen promotes upregulation of OXTR Mediumdose • Less likely to start labor spontaneously • Require higher doses of oxytocin during labor augmentation Highdose • BMI >30, more likely to need to go over 20mu/min BalkiMetal.(2013) Anesthesiology.

Maestrini (2018)EuropeanJournalofObesity Carlson(2015)ReproductiveBiology&Endocrinology 24 Adamsetal(2019)Am.JPerinatology Are associations between differences in oxytocin function and other conditions a consequence of the condition? UniversityofWashington

Or does oxytocin dysregulation/dysfunction contribute to the development of the condition?

26

Genotype Variation Riskallele

(2017)

Protectiveallele

Single Nucleotide Polymorphism (SNP)

27 28

Epigenetic Labor & Genotype Regulation

• DNA methylation less OXTR gene • Postpartum depression • Preterm delivery

Oxytocinmax Durationof TotalDose Cesareanbirth infusionrate inducedlabor

Grotegut,C.A.,Ngan,E.,Garrett,M.E.,Miranda,M.L.,AshleyͲKoch,A.E.,&Swamy,G.K. (2017).AmericanJournalofObstetricsandGynecology

29 30 http://www.beatricebiologist.com/ OXT production: Perinatal Mood Oxytocin, mood, lactation

• Stuebe, A. M., Grewen, K., & Meltzer-Brody, S. (2013). Journal of Women’s Health, 22(4), 352–361. • Association between suboptimal lactation outcomes and perinatal depression

www.NewMomHealth.com

Dr.AlisonStuebe 31 UniversityofNorthCarolina 32

N=46,732 singleton births (9,648 oxytocin, 21%) Diagnosis of postpartum mood disorder or medication

History of mood disorder/meds Æ 36% more likely to have PP diagnosis

n=47 No prior history of mood disorder/meds 11BF+symptoms Æ 32% more likely have PP diagnosis 28BF–symptoms KrollͲDesrosiers ARetal.DepressAnxiety.2017;34(2):137Ͳ146. 8nonBF

1) Is synthetic oxytocin a contributing factor in development of PPD

Cox,E.Q.,Stuebe,A.,Pearson,B.,Grewen,K.,Rubinow,D.,&MeltzerͲBrody,S.(2015).Psychoneuroendocrinology,55,164–172. or 2) a symptom of OXT/OXTR dysfunction?

Future Oxytocin Therapeutics Future of Oxytocin Research • Atosiban: oxytocin receptor antagonist

– Preterm labor?

• Carbetocin: longer-lasting agonist (40 min half life)

– Postpartum Hemorrhage?

• Intranasal Oxytocin: (central vs. peripheral debate)

– Obesity/ blood glucose regulation

– Cardiovascular protection during ischemia

– Social behaviors/ mood symptoms

35 36 OxytocinReceptorExpressionIn Pregnancy:WhenDoesItTurnOn? ‰ Dr.JessicaReidͲ FamilyPlanningFellow • samplesmyometriumthroughoutlate2nd trimestertoterm • determineatwhatGAOXTRexpressionincreases • informclinicalmanagementofpostͲabortionhemorrhage

HigherDNAm =LowerOXTR Æ lessuterinetone

• PostpartumHemorrhage • Moreexogenousoxytocin

Secondaryoutcomes • PostpartumMood • SuboptimalLactation

References • Ottenhausen,M.,Bodhinayake,I.,Banu,M.A.,Stieg,P.E.,&Schwartz,T.H.(2015).VincentduVigneaud:followingthesulfurtrailtothe discoveryofthehormonesoftheposteriorpituitaryglandatCornellMedicalCollege.JournalofNeurosurgery,1–5. • Martin,J.A.,Hamilton,B.E.,Osterman,M.J.K.,Driscoll,A.K.,&Drake,P.(2018).Births:Finalfor2017.NationalVitalStatisticsReports,67(8), 1–49.Gimpl,G.,&Fahrenholz,F.(2001).Theoxytocinreceptorsystem:structure,function,andregulation.Physiol Rev,81(2),629–683. Summary • Bell,A.F.,Erickson,E.N.,&Carter,C.S.(2014).Beyondlabor:Theroleofnaturalandsyntheticoxytocininthetransition tomotherhood. JournalofMidwiferyandWomen’sHealth,59(1),35–42. • Lee,H.J.,Macbeth,A.H.,Pagani,J.H.,&ScottYoung,W.(2009).Oxytocin:Thegreatfacilitatoroflife.ProgressinNeurobiology,Vol.88,pp. 127–151. • Yang,H.ͲP.,Wang,L.,Han,L.,&Wang,S.C.(2013).NonsocialFunctionsofHypothalamicOxytocin.ISRNNeuroscience. • OXT/OXTR genes are pleiotropic • Feldman,R.,Monakhov,M.,Pratt,M.,&Ebstein,R.P.(2016).OxytocinPathwayGenes:EvolutionaryAncientSystemImpactingonHuman Affiliation,Sociality,andPsychopathology.BiologicalPsychiatry. • BellAF,CarterCS,SteerCD,etal.InteractionbetweenoxytocinreceptorDNAmethylationandgenotypeisassociatedwithriskof postpartum • depressioninwomenwithoutdepressioninpregnancy.FrontGenet.2015;6(38):1161–10.. OXT works as a neurotransmitter in addition to • KimmelM,CliveM,Gispen F,etal.OxytocinreceptorDNAmethylationinpostpartumdepression.Psychoneuroendocrinology. • ReinerI,VanIjzendoorn MH,BakermansͲKranenburg MJ,Bleich S,Beutel M,Frieling H.Methylationoftheoxytocinreceptorgeneinclinically having many peripheral functions depressedpatientscomparedtocontrols:TheroleofOXTRrs53576genotype.JPsychiatr Res.2015;65:9Ͳ15.. • Behnia F,Parets SE,Kechichian T,etal.FetalDNAmethylationofautismspectrumdisorderscandidategenes:associationwithspontaneous pretermbirth.AmJObstet Gynecol.2015;212(4):533.e1Ͳ.e9.. • Clinicians interact with oxytocin system variation • Rijlaarsdam J,vanIjzendoorn MH,Verhulst FC,etal.Prenatalstressexposure,oxytocinreceptorgene(OXTR)methylation,andchildautistic traits:ThemoderatingroleofOXTRrs53576genotype.AutismRes.2017;10(3):430Ͳ438.. • Elagoz Yuksel M,Yuceturk B,Karatas OF,Ozen M,Dogangun B.Thealteredpromotermethylationofoxytocinreceptorgeneinautism.J • New research and therapies on the horizon may Neurogenet.2016;30(3Ͳ4):280Ͳ284.. • JackA,ConnellyJJ,MorrisJP.DNAmethylationoftheoxytocinreceptorgenepredictsneuralresponsetoambiguoussocialstimuli.Frontiersin HumanNeuroscience.2012;6.. one day influence care during the childbearing • KimJ,Pitlick MM,ChristinePJ,etal.GenomeͲwideanalysisofDNAmethylationinhumanamnion.ScientificWorldJournal. 2013;2013(4):678156–11.. • Mitsuya K,SinghN,Sooranna SR,JohnsonMR,MyattL.EpigeneticsofHumanMyometrium:DNAMethylationofGenesEncodingContractionͲ process as we broaden our view of oxytocin as AssociatedProteinsinTermandPretermLabor1.Biol Reprod.2014;90(5):590Ͳ598. • vanVliet,E.O.G.,Nijman,T.A.J.,Schuit,E.,Heida,K.Y.,Opmeer,B.C.,Kok,M.,…Oudijk,M.A.(2016).Nifedipine versusatosiban for more than a uterotonic. threatenedpretermbirth(APOSTELIII):amulticentre,randomised controlledtrial.TheLancet,387(10033),2117–2124. • Jin,B.,Du,Y.,Zhang,F.,Zhang,K.,Wang,L.,&Cui,L.(2016).Carbetocin forthepreventionofpostpartumhemorrhage:asystematicreviewand metaͲanalysisofrandomizedcontrolledtrials.TheJournalofMaternalͲFetal&NeonatalMedicine,29(3),400–407. • Parker,K.J.,Oztan,O.,Libove,R.A.,Sumiyoshi,R.D.,Jackson,L.P.,Karhson,D.S.,…Hardan,A.Y.(2017).Intranasaloxytocintreatmentfor socialdeficitsandbiomarkersofresponseinchildrenwithautism.ProceedingsoftheNationalAcademyofSciencesoftheUnitedStatesof America,114(30),8119–8124. 39

Thank You

[email protected] Objectives

• Review the epidemiology of FDA-approved medication abortion in Oregon • Understand barriers to abortion access, particularly in rural Oregon • Compare strategies for medical abortion via Improved access to medication telemedicine: The TelAbortion Project abortion in Oregon using • Review a model for implementation of direct to patient telemedicine medical abortion in Oregon telemedicine

DATE: Nov 14, 2019 PRESENTED BY: Maureen Baldwin, MD MPH Pacific NW Update, Portland, OR

2

Disclosures

• Merck Pharmaceuticals – trainer • Bayer Healthcare – trainer, medical advisory committee 16.4 • Medicines360 – research site co-investigator 2006 11.1 • National Hemophilia Foundation – medical 2016 advisory committee

3

Oregon abortion rates

33% decline in a decade Office medication abortion: 20 - medical history 15 10 16.4/1000 - gestational dating 5 11.1/1000 - options counseling 0 2006 2016 - informed consent - medications 8,900 abortions per year *screening and prevention Æ half at Planned Parenthood clinics Æ 65% use medication abortion

5 6 Best practices – combined regimen Medication abortion <10 weeks

• Two medication regimen: – Mifepristone – Misoprostol taken 1-2 days later – Most pass the pregnancy in 4-6 hours

• Follow-up to ensure completed abortion – Self-evaluation + • Repeat ultrasound (1-2 weeks) • Serial blood tests (before and 1-2 weeks) • Negative pregnancy test (3-4 weeks)

7 8

Medication management of EPL - RCT Addition of mifepristone improves outcomes

Women receiving combined treatment were 63% less likely to need a procedure (NNT=6)

9 Schreiber et al. NEJM 2018 10

Safe and effective What am I going to do?

• 26 year old with 2 kids under 5 • Review of 2927 medical abortions <7 weeks – Serious adverse outcomes in 0.6% • Lives in Astoria • Infection in 17 • Just started a new job • Hemorrhage in 2 – ED visits in 1.3% • 6 weeks pregnant – Ongoing pregnancy in <1% • Seeking abortion – Aspiration procedure in <3%

11 Baldwin MK, Bednarek PH, Russo J. 2017 NAAFP conference poster 12 How soon can it happen? How much does it cost?

• Where can I go that’s safe? • Medicaid: free • How far away? • Private insurance: variable • How much time does it take? • Planned Parenthood: $475 • How long do I need to be off work? • OHSU out of pocket: $514 • How much childcare will I need? Æ In-hospital ~$10,000 • How much does it cost? • Will it be private?

13 14

Where can I go?

97 miles to Portland from Astoria $ tank of gas $ full day of childcare

Æ 30% of Oregon women live in a county without an abortion provider

15

Health system barriers

• Trained providers • Health system restrictions – Ethical and Religious Directives (ERDS) • FDA restrictions – Risk Evaluation and Mitigation Strategy (REMS) – mifepristone not in pharmacies

18 Abortion restrictions by state FDA restrictions

remappingdebate.org

20

FDA restrictions Mifeprex prescribers:

• Review prescribing information • Complete Prescriber Agreement Form – Have the following qualifications: • Ability to assess the duration of pregnancy accurately • Ability to diagnose ectopic pregnancies • Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary • Will follow the guidelines for use of Mifeprex

22

FDA protocol for medical abortion Telemedicine in OR/WA Prior version 2011-2016 Current since March 2016 • Synchronous two-way interactive video • Pregnancy up to 49 days • Pregnancy up to 70 days conferencing • Mifepristone 600 mg • Mifepristone 200 mg • Mifepristone administered • Mifepristone dispensed • Visit occurs/originates where the patient is located • Misoprostol taken in office • Misoprostol taken at home – Site to site • Follow-up in clinic • Follow-up as preferred – Direct to patient • Insurance coverage = office visits Æ FDA exemption filed (an IND) to be able to use medication off-label for research

http://cchpca.org

24 ER2 Slide 25

ER2 Switched out the website to our new one. Elizabeth Raymond, 10/22/2019

www.telabortion.org

www.telabortion.org

Visitflow Videoconferencemedication abortion: Ͳ medicalhistory

Ultrasound Video Ͳ reviewofgestationaldating Screening Package Follow-up Lab tests Visit Ͳ optionscounseling Ͳ informedconsent Ͳ medications *screeningandprevention ER4 Slide 30

ER4 Replaced the map. Elizabeth Raymond, 10/22/2019 StatesandPartners

MT(PPMT) OR&WA MN(PPMNS) (OHSU,PPCW)

ME&NY (MFP)

CO&NM (PPRM)

GA(carafem) HI(Univ ofHI)

AbortionsProvided 522 500 Total Oregon 400

300

200

100 88

0

Through October 20 2019

DistancefromHometoSite AbortionOutcome

TotalexcludingHawaii 522 packagessent Oregonresidents 30% • Lostorstillbeingfollowed:22% • Changedmindaboutabortion:2% 20% • Completedabortion:76%

10% Completemedicalabortion:95% 0% <10 10Ͳ49 50Ͳ99 100Ͳ149 ш150 Miles Aspiration:5% Complications Acceptability N=343 444patientswithfollowͲup Satisfaction Recommendtoafriend • Norelatedsignificantcomplications • 2hospitalizations,neitherrelatedto telemedicine Verysatisfied:81% Yes:96% • 37EDvisits(8%),mostlyforbleeding/cramping വ Allbut8livedш50milesfromstudysite

Unsatisifed:0.6% Satisfied:19% Noormaybe:4%

QuotesfromOR Implementation outcomes More Facetoface Iwasableto comfortable experience decidewhen ADVANTAGESNOT CHALLENGES CHALLENGES inown wasgreat &howwas home bestforme PrivacyCommunication Billing and coding Patient-centeredFinding ultrasound sites Multiple components Wecould ConvenienceRhogam Multiple communications doitonour Notneeding EfficiencyFollow-up Dis-coordinated medical owntime. todrive60+ Equivalent systems milestwice Lost opportunities for screening and prevention Didn'thave tofindcare Done Confidentiality forchildren quicker 38

www.earlyoptionpill.com Thankyou!!! [email protected]

www.telabortion.org

OHSUPhysicianAdvice& ReferralService • 503Ͳ494Ͳ4567 • 800Ͳ245Ͳ6478(tollͲfree)

39 Disclosures Telemedicine to Evaluate and Manage Perinatal Risk

No financial conflicts of interest 11.14.19 Coping with just turning 50 and having a 21 y.o. daughter Leonardo Pereira MD, MCR, Associate Professor Director, Division of Maternal-Fetal Medicine Bias towards the Philadelphia Eagles Oregon Health & Science University [email protected]

Telemedicine in MFM Overview Telemedicine in Perinatology

Current utilities Well suited for telemedicine

Advantages High frequency of consultative services

Challenges High frequency of ultrasound services

Future directions

Telemedicine Current Utilities Telemedicine Current Utilities

Arkansas ANGELS program since 2003 MFM consultation Coordinated state wide telehealth with live ultrasound and Genetic counseling consultation

Fetal ultrasound Complex case management

Prenatal visits Virtual neonatal rounds - telenursery

Diabetes management Implementation of OB psychiatric care

Postpartum visits 24/7 RN call center Telemedicine Current Utilities Telemedicine Current Utilities

Arkansas ANGELS program Georgia 2011: Private MFM and SW Georgia Public Health District partnership to provide telemedicine Successes: consults to 500 high risk-risk Higher rate of delivery of high risk neonates at women in a centering program: tertiary center

Reduced infant mortality Reduced PTB from 18 to 8% Coordinated care for fetal anomalies during 18 month study period

Telemedicine Current Utilities Telemedicine Current Utilities

Genetic Counseling: At OHSU: Patient satisfaction has been good (surveys) Ultrasounds Concerns about assessing non-verbal Genetic Counseling communication for difficult conversations

Educational conferences: OPNN (Oregon Decreased travel and cost to patients Perinatal and Neonatal Network) Decreased cost to practices / health systems

Telemedicine Current Utilities Telemedicine Current Utilities

GDM management: OB outcomes meta-analysis: Lannsens et al 2017

No data that TM improves outcomes over Some data indicates cost savings standard care Some improved outcomes: Patient perceived increase in how closely reduced unscheduled visits GDM monitored they are) increased GA at delivery decreased LBW and NICU admission rates Reduced travel and unscheduled visits quality of evidence is low (bias) Telemedicine Current Utilities Telemedicine Advantages

Telemedicine Accuracy for fetal sonography Financial benefit to patients – transportation All scans 2010-2012 showed similar accuracy; costs, missed time off work anomaly prevalence 5.7% Patient’s family may be present more easily 2368 TM scans; 3145 live in person scans TM : sensitivity 57%, specificity 98% Provide specialty services remotely where they LIVE: sensitivity 77%, specificity 91% are not locally available TM exams completed in 1 visit 82% Rabie NZ et al, JUM 2017

Telemedicine Advantages Telemedicine Advantages

Patient engagement is higher Providers/Health Care System benefits from reduced cost and time of providers traveling to satellites Patient satisfaction is higher

Local health care providers/systems increased charges and revenue Uncertainties:

Improved educational opportunities for local Impact on health outcomes providers: OPNN example Impact on costs

Telemedicine Challenges Telemedicine Challenges

Need high speed T1 optic fiber network for high speed image Reimbursement transfer In U.S. health insurance companies may not Sonographer limitations: experience, NT certification, ECHO, reimburse services or reimburse them at a lower Dopplers rate Equipment limitations Variable, determined at the state level but increasing in general

Most reimburse real time care; less commonly store and forward or remote patient monitoring (RPM) Telemedicine Challenges Telemedicine Challenges

Licensure: Medicaid Reimbursement Policies Medical licensure in Oregon allows you to bill 2014: 32 states had guidelines on telemedicine Medicaid for telehealth services in several states: Idaho, Montana, Utah, Washington and 2018: 49 states had guidelines on telemedicine Wyoming (MASS)

Medical licensure in Washington allows you to bill 3 guidelines specific to perinatal care Medicaid for telehealth services in Alaska, Idaho, AJOG, EM Okoroh et al 2016 Montana, Oregon, Utah and Wyoming CCHP 50 state report 2018; cchpca.org

Telemedicine Challenges Telemedicine Challenges

Store and forward as opposed to live in time interactions Remote Patient monitoring (RPM)

Teleradiology is reimbursed and not considered store and forward Only reimbursed in 20 states:

Store and forward examples: Fax reports, Derm pictures, dental exam pictures – 11 states Washington and Utah currently reimburse this (Washington, California, and Nevada do) Usually only for specific chronic conditions: physician to physician email consults – only Connecticut COPD, asthma, diabetes CHF reimburses at present time

Telemedicine Challenges Telemedicine Future Directions

Virtual prenatal care: limited data, similar Limited (but increasing) data on outcomes pregnancy outcomes, high satisfaction among middle-high income patients who already have Some publications showing telemedicine children Pflugeisen BM. Am JMCN 2016 outcomes inferior to person to person care Pflugeisen BM, MCH 2017

More recent publications show equivalent outcomes Fetal Heart Rate Monitoring: private companies developing tech for FHR Telemedicine Future Directions Telemedicine Future Directions

HOTEL study: multicentered Dutch RCT HOTEL study: multicentered Dutch RCT Inclusions: preeclampsia, IUGR, PPROM, prior 416 patients > 26 weeks singletons stillbirth, decreased fetal movements

Wireless CTG and automated BP monitoring Primary outcome is composite adverse perinatal outcome Randomized to in hospital management versus remote monitoring from home Secondary outcomes: safety satisfaction, cost effectiveness van den Heuvel JFM, BMJ Open 2019 van den Heuvel JFM, BMJ Open 2019

Questions? Contact me

OHSU Physician Advice & Referral Service •503-494-4567 •800-245-6478 (toll-free) Disclosures y Ihavenoconflictsofinteresttodisclose.

y FundingforthisworkhascomefromtheNational InstituteofHealth y NIMH:R34MH092503,R34MH092503,R21MH112038 ChristinaNicolaidis,MD,MPH y NICHD:R21HD078830 Professor,SchoolofSocialWork,PortlandStateUniversity y TheOregonClinicalandTranslationalResearchInstitute AssociateProfessor,SchoolofMedicine,OregonHealth&ScienceUniversity (OCTRI),grantnumberUL1RR024140fromtheNationalCenter CoǦDirector,AcademicAutismSpectrumPartnershipinResearchand forResearchResources(NCRR),acomponentoftheNational Education(www.AASPIRE.org) InstitutesofHealth(NIH),andNIHRoadmapforMedical EditorǦinǦChief,AutisminAdulthood Research

Today’sAgenda

y AutismBasics y AutismandGender y HealthCareforAutisticAdults y SexualHealthandPregnancy

FrameworksandLanguage y Neurodiversityparadigm y Diversityinneurodevelopmenttobevaluedinthesame y AcademicAutismSpectrumPartnershipin waythatwevalueotherformsofhumandiversity ResearchandEducation(www.aaspire.org) y Socialmodelofdisability y CoǦFoundedin2006withDoraRaymaker y Focusonsupportsandaccommodationsinsteadofcures y Autisticadults,academics,familymembers, y Ongoinglanguagedebate disabilityservicesandhealthcareproviders y PreferenceamongselfǦadvocatesforidentityǦfirst(e.g. y CommunityBasedParticipatoryResearch autisticadult)vs.personǦfirst(e.g.adultwithautism) y Autisticadultsserveasequalpartnersthroughout y SimilartoDeafcommunity allphasesofourresearchprojects.

Nicolaidisetal,PCHP,2011 Nicolaidis2012;Gernsbacher,2017;Kappetal,2013;Kennyetal2016;Sinclair,1999 ProviderKnowledgeandTraining

Kaisersurveyof 922healthcare providersfor adults

Zerbo etal,JADD, 2015

PrevalenceofAutism HistoryofASD y Dramaticriseofdiagnosedprevalenceovertime y Firstdescribedin1940’s(butlikelyalwaysexisted) y CDC:1in59childrenidentifiedwithanASD y FirstincludedinDSMin1980 y PopulationǦbasedstudy:1%ofadultsmetcriteriaforASD y NotevenadxwhenbabyǦboomerswerekids y Feweradultshavebeenformallydiagnosed. y “Asperger’sDisorder”addedin1995;heightened y Majorityofincreaseinprevalenceislikelyduetochanges awarenessthroughlate90’sandearly200o’s. indiagnosticcriteriaandhowtheyareapplied. y MostGenǦX’ers notdiagnosedinchildhood y ContinuedunderǦdiagnosisinfemalesandpeopleofcolor y Millennialswithdxnowenteringadulthood y DSMǦ5unifieddiagnosesofautisticdisorder, Asperger'sdisorder,andPDDǦNOSinto“Autism SpectrumDisorder”

Baio,2018;Brugha 2009;Hill2015;Liptak 2008;Dean2017

DSMǦ5CriteriaforASD A. Persistentdeficits 1.DeficitsinsocialǦemotionalreciprocity insocial 2.Deficitsinnonverbalcommunicativebehaviorsusedfor communicationand socialinteraction socialinteraction 3.Deficitsindeveloping,maintaining,andunderstanding AFewCaveats… acrossmultiple relationships contexts. (3of3) y Donottorelyonstereotypes. B.Restricted, 1.Stereotypedorrepetitivemotormovements,useof repetitivepatternsof objects,orspeech y Fallacyofthelinearspectrum behavior,interests, 2.Insistenceonsameness,inflexibleadherenceto y Skillsandchallengesfallalongspectraonmultipleaxes. oractivities routines,orritualizedpatternsofverbalornonverbal (2of4) behavior y Withineachaxis,skillsandchallengescanchange 3.Highlyrestricted,fixatedintereststhatareabnormalin dependingonenvironmentalstimuli,supports,and intensityorfocus 4.HyperǦ orhyporeactivity tosensoryinputorunusual stressors. interestinsensoryaspectsoftheenvironment y Skillsandchallengescanchangeovertime. C.Symptomsmustbepresentintheearlydevelopmentalperiod(butmaynotbecomefullymanifestuntilsocial demandsexceedlimitedcapacities,ormaybemaskedbylearnedstrategiesinlaterlife) y Autistictraitscanbebothstrengthsandchallenges. D.Symptomscauseclinicallysignificantimpairmentinsocial,occupational,orotherimportantareasofcurrent functioning. y Autisticpeopledonotalwaysshyfromsocial E.Thesedisturbancesarenotbetterexplainedbyintellectualdisabilityorglobaldevelopmentaldelay. IntellectualdisabilityandautismspectrumdisorderfrequentlycoǦoccur;tomakecomorbiddiagnosesofautism interactionsandsomemaintainstrongfriendships. spectrumdisorderandintellectualdisability,socialcommunicationshouldbebelowthatexpectedforgeneral developmentallevel. AssociatedConditions BehaviorChange y Epilepsy y Commonmedicalproblemscanpresentinunusualways. y Gastroesophagealrefluxdisease(GERD),constipation, y Illnessoftenpresentsasachangefrombaselinebehavioror dysphagia function. y Feedingandnutritionproblems y Patientswhopresenttopsychiatryfrequentlyhave y Metabolicsyndrome undiagnosedorunderǦtreatedmedicalproblems. y Anxiety,depression,sleepdisturbances,andsuicidality y ShortǦtermuseofrisperidoneoraripiprazolecanbe y PostǦtraumaticstresssymptoms(includingthose effectiveintreatingirritability,hyperactivity,and associatedwithchildhoodtreatments) stereotypiesinautisticchildren,buttherisksandside y Higherriskofexperiencingviolenceandabuse effectsoftenoutweighthebenefits.NolongǦtermdata. victimization y y Reducedlifeexpectancy SomedataonnonǦpharmacologicapproaches (mindfulness,CBT,exercise,improvedcommunication). Croen 2015;Woolfenden 2012;Hivikoski 2016;Nicolaidis2014;Kupferstein 2018. Nicolaidisetal,MedClin NAm,2014

SexDifferencesinPrevalence y “4:1ratioofmalestofemales” y Biologicaldifference? y Skeweddiagnosticcriteria y UnderǦdiagnosis y CluestounderǦdiagnosis y Moresevereimpairmentsingirlswithdiagnosis y Laterageatdiagnosis y RecentincreaseofCDCprevalenceestimatesfrom1in 68to1in59largelyattributedtoincreasingdiagnosis ingirlsandchildrenofcolor

Hill2015;Bageer 2012,

Camouflaging GenderIdentity y StrikinglyhighnumberofnonǦcisǦgenderedautistic adultsinautisticselfǦadvocacycommunity y Small,butgrowingliteratureconfirmingassociation y Higherratesofgenderdysphoriaamongstautistic childrenandadults y Higherratesofautistictraitsordiagnosesamongst patientsseekingtreatmentforgenderdysphoria y Biologyvsgenderasasocialconstruct? y “Idon’tfeellikeaparticulargenderI’mnotevensure whatagendershouldfeellike” Gliden etal,SexMedRev,2016;Kourti etal,AutisminAdulthood,2018 Laietal,Autism,2017 ClinicalImplicationsforOb/Gyn y Highlikelihoodthatmanyofyourpatientsarenot formallydiagnosed y Potentialbenefits(andcosts)toadultdiagnoses y Patientsmaybecamouflagingtraits,(butpossiblyto thedetrimentoftheirhealth);maynotbeabletodoso understress(e.g.illness,hospitalization,surgery). y Patientsidentifiedasgirlsatbirthmaynotidentifyas womenbyadolescenceoradulthood,butmaystill needob/gyn care–greatsensitivityneededtoboth autismandtransissuestoprovidequalitycare.

HealthcareDisparities BarrierstoHealthcare y Onlinesurveycomparingautisticadults(N=209)tononǦ y Autisticpeopleandpeoplewithotherdisabilities autisticadults(N=228)withandwithoutotherdisabilities. experiencemanymorebarriersthanpeoplewithout disabilities. y Greaterunmethealthcareneeds y Autisticgroupreportedmorebarrierstohealthcarethan y Physicalhealthneeds(aOR 1.9) peoplewithotherdisabilities,plusdifferentpattern. y Mentalhealthneeds(aOR 2.2) y Topbarriers: y Prescriptionmedicationneeds(aOR 2.8) y Fearoranxiety(35%) y GreaterEmergencyDepartmentuse(aOR 2.1) y Can’tprocessinformationfastenoughinrealǦtime(32%) y LoweruseofPapSmears(aOR 0.5) y Concernaboutcost(30%) y LowersatisfactionwithpatientǦprovidercommunication y Facilitiescausesensoryissues(30%) andhealthcareselfǦefficacy y Difficultycommunicatingwithproviders(29)

Nicolaidisetal,JGIM 2013 Raymaker etal,Autism,2017

HealthcareExperiences SensorySensitivities “Thelightsintheofficeareverybrightandthatis exacerbatedbythewhitewalls.Sometimesthewaiting roomsarecrowdedandIcannotfilteroutthe backgroundofpeopletalkingorshufflingmagazines.I feeldisorientedbybeingleddownlonghallwaysto differentrooms…Iamnotabletobringupmyconcerns becauseitisallIcanmanagetofigureoutwhatthe doctorissayingsoIcanrespondtohisquestions.Buthe refillsmyusualmedsandIgoonmyway.”

39AutisticAdults 16Supporters Nicolaidisetal,JGIM 2015 SensorySensitivities ChallengeswithBodyAwareness y Usenaturallight,turnofffluorescentlights,makethe “Likewhentheyaskifpainisshootingorstabbingorburning,it’s lightingdim. like,Idon’tknow,itjustfeelsfunny.” y Trytoseethepatientinaquietroom. “Theproblemisitisdifficultformetoisolatespecificsourcesof painandidentifydurationandintensity.It’ssortoflikethe y Onlyhaveonepersontalkatatimeandtrynottotalkto equivalenttowhitenoise.” thepatientwhilethereareothernoises. y Avoidunnecessarilytouchingthepatient(forexample,to y Considerthepossibilitythatdifferencesinbodyawareness expressconcern). maybeaffectinghowapatientrecognizesordescribesa symptom,orhowapatientrespondstoillness. y Warnthepatientbeforeyoutouchhimorher. y Insomecases,youmayneedtodoadditionaltestingor imagingasinformationfromthehistoryandphysicalmay belimited.

CommunicationandOpennessto Providers’IncorrectAssumptions Accommodations y “IhaveusedmyAlphasmart [portablecommunication device]whenmyspeechistooslowordifficultto y “Ipreferandfinditeasiertocommunicateintext… understandformedicalappointments.Someofthedoctors ButwitheverydoctorIspeakto,theywaveawaythe havebeenreallygreat,butothershaveactedreally condescendingwhenIusedit,alsoimmediatelyassumingI noteǦcardandlookatmetoaskthesamequestionI couldn’tbealone,hadtohavehadparentstheretoo…SoI havejustansweredandinterpretmyconfusionasmy trytogowithout,evenwhenmyspeechisinapoorer beingnonǦcompliantwiththemedicine.Iwishhealth shape.” careproviderswouldreadthenotesImakeforthem.” y “UsuallywhenIdemonstratealargevocabularyorsome fundamentals,myneedsespeciallyaroundcommunication arethenignored.Mychoiceisthentopretendtobeless intelligentandaccepttheirinfantilism,ortobeconfused, frustrated,andstressedout.”

Communication NeedforConsistency y Checkyourassumptions. y Enablethepatientorsupporterstogetpicturesof y Usepreferredcommunicationmode theofficeand/orstaff. y Beveryconcreteandspecific. y Explain,indetail,whatislikelytohappenduring y AvoidopenǦended,broadquestions. thevisit. y Donotforcepatienttomakeeyecontact;itmay y Writedownalistoftopicsandpointoutwhen beuncomfortableorhindereffective thereisachangeoftopic. communication. y Showthepatientequipmentbeforeusingit.If possible,doa“trialrun”ofdifficultexamsor procedures. DifficultywithPlanning, Organization,andSequencing PatientAutonomy “Iwishtheyunderstoodhoweasyitistogetconfused y “JustbecauseImightneedmoreinformationto withalltheadministrativehoopsapatienthastojump understandthings,itdoesn’tmeantheycanorshould throughtogethelp.Itsoundspatheticatmyage,butI justtalktomelikeachildorleavemewithout needsomeonetoholdmyhand.Idon’tknowwhatIam knowledgeofmyownhealth.Mybodyismybody,and doing.ButnobodyunderstandsthatIneedthat,and myexperiencesandwishesaboutmybodyareMINE thereisdefinitelynobodywillingtodoit.” TOMAKE!” y WriteoutdetailedstepǦbyǦstepinstructions. y Haveofficestaffhelpwithcarecoordination. y Providedetailedinformationabouthowto communicatewithofficestaffbetweenvisits.

VeryHeterogeneousCondition

“Whenyouhavemetoneautisticperson,youhavemet oneautisticperson”

Needforindividualizedtools!

www.autismandhealth.org

ProviderandStaffStrategies AutismHealthcare AccommodationsTool(AHAT)

z Filloutasurvey z Computerusesanswerstocreateapersonalized andhealthcareproviderǦfriendlyreportof accommodations

35 SampleProviderReport PatientandSupporterInformation

(justpartofthefullreport)

38

FormsandWorksheets AASPIREToolkitEvaluation y MixedǦmethods,singlearm,1ǦmonthpreǦpostinterventionstudy designinrealǦlifesetting. y 170autisticparticipants;41PCPs y 95Ǧ97%founditeasytounderstand,important,&useful. y SignificantchangesbetweenpreǦ andpostǦtestin y Numberofbarrierstohealthcare y HealthcareselfǦefficacy y PatientProvidercommunication y Strongqualitativethemesaroundtoolkitutility y Meanstoclarifyandcommunicateneeds y ValidationofexperienceandempowermentreselfǦadvocacy y ImprovedselfǦefficacy;betterabletoprepareforvisits y Examplesofchangesinproviderbehaviors

Nicolaidisetel,JGIM 2016 39

NextSteps y CurrentNIMHǦfundedprojectintegratingtoolkitinto 3healthsystems(6interventionand6controlclinics) y NewcollaborationinUKtoadapttoolkitand disseminateitthroughoutNationalHealthService y NewcollaborationinAustraliatoadapttoolkitto inpatientandemergencymedicinesettings Pregnancy,Disability,and AutismandSexualHealth Women’s y SocietaldeǦsexualizationofpeoplewithdisabilities y Moststudiesofsexualbehaviorinautismuseparent Decisions report! y Greaterdiscomfortamongstparentscommunicating aboutsexwithautisticadolescents y Smallliteratureassessingsexualhealthdirectlyamong y NICHDǦfundedqualitativestudywith51women(34 autisticadolescentsandadults withintellectualdisabilityand17ontheautism y Lowerknowledge spectrum) y Greaterconcerns y CommunityAdvisoryBoardofautisticwomenand y Higherratesofexperiencingsexualabuse womenwithintellectualdisabilities Holmesetal,JADD,2014;Mehzabin andStokes,RASD,2011; BrownǦLavoieetal,JADD,2014

SignificantImpactofSocial Isolation DeterminantsofHealth y Beingapartfromastrongsocialsupportnetwork y Manyparticipantsdescribedstruggleswithabusive y Motherhoodand/ordisabilityasisolating partners,pasttrauma,poverty,substanceuse,thelegal y Mostwomenonlyreceivedsupportorhaddiscussions system,healthcomplications,andothersocial aboutpregnancydecisionsfromonlyasmallnumber determinantsofhealth. ofclosefamilymembers y “ItwaslargelydomesticviolenceandIdidn'tthinkIcould ManywomenfelttheneedtokeeptheirdecisionǦ takecareofababyonmyǦǦIdidn'thavethefinancial makingprivate resources,Ididn'tknowhowIwasgonna makeit,you know,Icouldn'tkeepajobdown,IlostmyjobwhileIwas pregnantand,youknow,Ididn'tknowwhatIwasgonna do.”

Isolation Discrimination y “Ikept[mydecisionǦmaking]tomyself.Ifiguredthe y Manystoriesofableism,racism,sexism lessIsayto[others]thelessIhavetohear.” y Somefearedtheirchildrenwouldbediscriminatedagainstif theyhadadisability y Socialexpectationthatwomenbecomemotherscaneitherbe y “Ijustfeltreallylikealoneanddepressedallthetime.I normalizing(iftheychoosetohavechildren)orsomethingthey couldn'treallytalktonobody….Ididn'treallyhavethe arediscriminatedagainstfor(iftheychosenottohavechildren) supportsǦǦIhadthesupportsoffindingstuffthatIneeded sometimes,butthesupportsoftalkin'tosomebodyabout “[I’dbeworriedifmychildhadadisability]‘causehowotherpeople acttopeoplewithdisabilities….Theydiscriminate….LikewhenI'm what'sgoin'onandhowI'mfeeling,youknow…” outandaboutsometimesdiscriminateagainstme…Idon'twanna bringakidupinthisworldbecausethisworld[scoffs]theydon't, theydon'tǦǦthisworlddon'thaveboundaries…onhowtheytreat people.” Independenceand AbleismWithinHealthcare Resilience “…justthelanguageandallofthepaperworkandquestionnairesaround genetictestingislikeincrediblyoffensive,Imeantheyrefertoeverything asbirthdefectsratherthandevelopmentaldisabilities….It’slikethe y Somewomenwereputunderalotofpressuretohaveachild,to entireinfrastructureissetuptodiscouragewomenfromcarrying abortachild,ortootherwisedowhatotherswantedthemto pregnanciestotermifthere'sanypossibilitythatthechildwillhavea y However,mostdescribedmakingtheirowndecisions,evenwhen disability.Andthatthere'sthis,thatthere'sthisimplicitbiasinthe othersdisapproved languageandinallconversationsaboutpregnancythatisallaboutfearof y WomenoftenhadasenseofprideabouttheirselfǦsufficiencyin disabilityand,um,youknowdisabilityasliketheultimatetragedythat theirdecisionsandtheirlives we'reworkingtogethertoavoid.Iwasjustmuchmoreawareofthat climate.EspeciallybecauseyouknowI'm42soobviouslythere'slikealot “IwasextremelystubbornandwhenImakeadecisionandIwant moregenetictestingandstuffthat'srecommendedwhenyou’repregnant somethingI'mnotgonna letsomebodystandinmyway...Iwasnot atthisageandI'mautisticandIhaveachildwho'sautisticandIhave goingtohaveanabortionandnobodywasgoingtotellmewhattodo. physicaldisabilitiesandsomeofthosearegeneticandlikethere'savery, Soregardlessofhowanybodyinmyhousehold,thepeopleIlivedwith, oranybodyfeltaboutit,itdidnotmattertome…youcannottellme veryhighchancethatthischildwillhavesomedisabilityoranother.AndI whattodowithmybody.” don'tfuckin'care[laughs]likeyouknowthat'snot,that'snotimportant tome.

NotSoDifferent ResourceNeeds

y Womendescribedmotivationsfortheirdecisionsto y Mostwomenhadnotroublefindingprenatalcareor becomeornotbecomepregnantthatweren’t providers qualitativelydifferentfromanywomen’smotivations– y MostwomenknewwheretolookforresourcessuchasWIC desireforfamily,biologicalage,positive(ornegative) y Manywomenmentionedneedsin: experienceswithchildrenandbabysitting,copingwith y Accessiblepregnancyandmotherhoodtrainingprograms griefafteramiscarriage,notwantingtopassalong y Interactionswithwomenlikethemaroundpregnancyand traumatheyexperiencedtoachild,etc. motherhood y Knowingwhattherealityofpregnancyandmotherhoodis like y Accessibleeducationonbirthcontrolandfamilyplanning

VideoSeries ResourceDevelopment 1. Introduction 2. MakingDecisions y TalkedwithCABaboutinterviewfindingsandtheir AboutPregnancy ownexperiences 3. TalkingwithOthers AboutPregnancy y Collectivelydecidedtomakevideosrelatedtokey 4. Managing findings Pregnancy 5. Copingwith y Scriptedandcreatedincollaborationbetween,coǦ Discrimination,the investigators,CAB,andparticipantsfromtheresearch LegalSystem,or Mistreatment study 6. Healthand y https://pregnancyanddisability.org Pregnancy 7. Motherhoodand y Proposalunderreviewtodevelopandtestpregnancy LookingBack decisionaid 8. AboutThisSeries Ifyouonlyremember3things… y Trytounderstandandmeetyourpatients’ accommodationandsupportneeds. y OurtoolkitmayhelpǦ www.autismandhealth.org y Activelyengageautisticpatientsindiscussionsabout sex,contraception,andpregnancychoices. y Recognizethatyourautisticpatientsmaybe experiencingsignificantisolationanddiscrimination. y Avoidableistlanguageandconcepts y Offerresourcesatwww.pregnancyanddisability.org

ManyThanksto… y TheAASPIRETeam(www.aaspire.org) y DoraRaymaker,PhD,KatieMcDonald,Phd,E.Ashkenazy,MelBaggs, JaneRake,StevenKapp,PhD,TobiRates,JD,JoelleSmith,Andee Joyce, MorriganHunter,Micheal Weiner,MD,MPH,ClarissaKripke,MD, Mirah Scharer,AlannahMitchell,GavinSchneider,KellyZhen y ThePregnancyDecisionsProjectTeam (www.pregnancyanddisability.org) y MaryOschwald,PhD,DoraRaymaker,PhD,MaryAnnMcCammon, DNSc,MichelleBerlin,MD,Andee Joyce,AnnieWallington,E. Ashkenazy,PhoenixLomis,SherriOsburn,andSonjaSizemore,Khaki Marino,PhD ProjectNurture

PacificNWUpdateinOb/Gyn andWomen’sHealth11/14/19

AmandaRisserMDMPH,Sr.MedicalDirectorofSubstanceUseDisorderServices Collaborativecarebetweenperinatalservicesandsubstanceusedisorderservices SupportedbyAffordableCareActTransformationFunds

@cccportland @cccportland

ModelComponents: SomeOHSU/CODAdata • Pregnancycare,careformotherandinfantafterbirth • >53womenandtheirbabies. • ReceiptofMSR(buprenorphineormethadone) • >50%ofthepatientsrequiredresidentialtreatment. • RNcasemanagement • Professionaldoulasupport(PeerRecoveryMentor) • Morethanhalfofthepatientswereconcurrentlyusing • Teachingandmentorship. methamphetamines. • 25%wereusingmarijuana. Importantfeatures • 88%wereusingtobacco. • Careforwomanandchildtooneyearafterthebirth • 50%oftheirbabiesrequiredtreatmentforneonatalopioidwithdrawal • Groupcaremodel syndrome. • Integrationandinnovationinsystems(physicalhealth,mentalhealth, substanceusetreatment,hospitals) • CollaborationwithSocialServices

@cccportland @cccportland

Breastfeeding? MoreOHSU/CODAdata • 70%breastfedwithin24hours • PostpartumContraception: • 44%breastfeeding3monthspostpartum • 6%tuballigation • LOTSoftroublewithinfantweightgainandbreastfeeding. • 15%injection •17%implant(inhospital!) • Patientsneedagreatdealofsupportthroughthistime. • Breastfeedinghasbeensomethingwe’vebeenespeciallychallengedby. •26%IUD! • Parenting! • 76%ofourpatientsgohomewiththeirbabies. • 70%areshortandlongtermcaregivers. • 18%experiencetemporaryrelinquishmentoftheirbabies. • ThesebenefitswereseencountyͲwide. • Thisisthemainsourceofsystemcostsavingsforthismodel.

@cccportland @cccportland OtherOutcomes:SystemInnovation SystemInnovation:changingapproachto • Mostprojectnurturecollaboratives changedtheirsystemsofcare: NeonatalOpioidWithdrawal(NOW) • OHSUͲ rewrotetheneonatalopioidwithdrawalprotocols • ProvidenceͲ introducedbuprenorphineprescribingintoaresistantsystem • NICUadmission • LegacyͲ developedaprotocolforuniversalsubstanceusedisorderscreening • Separatingmomandbaby • Highlevelsofexposureto • Theseactivitieschangedtheregionofcare:evidencethatcountyͲwide, pharmacologictreatment projectnurtureactivitieschangedthewaythatcarewasdeliveredand • Finnegan“NASScores” changedoutcomesofcare. • PoorinterͲobserverreliability • JustOneSneeze • Disruptiveneurologicstresstest • Longtaperup&down • 17daysLOSoverall • 23daysLOSforthosetreated

LOS=LengthofStay NICU=NeonatalIntensiveCareUnit @cccportland (Jansoon,2017)(McQueen,2016) @cccportland NAS=NeonatalAbstinenceSyndrome

GrossmanYaleStudy2017:EatSleepConsole OHSUDoernbecherBaselineData • PDSACycles: FromSept2015Ͳ Feb2017 Beforethepolicy,slowlystartingtoroomin

“Exposed” “Diagnosed” 43 49 • 287infantsfrom2008Ͳ 2016 P04.49 InfantsAdmitted P96.1 InfantsAdmitted • Outcomes: Newborn 7.7 Neonatal 18.8 • LOSdecreased: 22.4d Æ 5.9d AverageLOS Abstinence AverageLOS • Treatmentwithmorphinedecreased: 98% Æ 14% affectedby 5.3 Syndrome 7.2 • Costdecreased: $44K Æ $10.2K maternaluse AverageNICULOS AverageNICULOS • Noreadmissions,noadverseevents ofdrugsof (AKANOW) addiction

LOS=LengthofStay NICU=NeonatalIntensiveCareUnit @cccportland LOS=LengthofStay NICU=NeonatalIntensiveCareUnit @cccportland LCL=lowercontrollimit UCL=uppercontrollimit

GoalsofPolicyChange ComfortisfirstlinetreatmentforNOW • Tend to all crying with consoling (swaddle, non-nutritive sucking, 1. Focusoncomfort rocking, holding) =LessPharmacologicManagement • Frequent skin to skin or cuddling by birth mother, family or volunteers 2. PrioritizeRoomingIn =NomoreNICU • Minimize interruptions, avoid waking for cares, bundle care • Quiet any noises, dim bright lights 3. FocusonInfantFunctionAKAEatͲSleepͲConsole =NoMoreFinneganScoring • Ensure optimal feeding • Skin care with all diaper changes 4. LessPharmacologicManagement =MorphinestartsasPRN(asneeded)

NICU=NeonatalIntensiveCareUnit @cccportland @cccportland Roominginisprioritized: NomoreFinnegan:EatͲSleepͲConsole(ESC) • RoomingͲinonMBUÆ DoernbecherInpatient Pediatricsoncemomdischarged • NomoreNICUadmissionsforNOW • Participationofparents,familyorcaregivers • Provideeducationandsupporttoparents • Volunteers

InfantsonmorphinedonotrequirepostͲdose monitoringatlowdoses(<0.12mg/kg/dose)

NICU=NeonatalIntensiveCareUnit @cccportland @cccportland

Ourresults:PreandPostintervention Otherdevelopments: • NosignificantchangeinLOS:ourLOSalreadyrelativelyshort • ProjectNurturespecificallycalledoutinthegovernor’sbudget. • Decreaseininfantsgivenmorphine:40%to20% • Otherprogramsemerging:Kaiser,Women’sHealthcareAssociates. • VERYSIGNIFICANTdecreaseinamountofmorphinegiventoinfants: • Expandedaccesstowithdrawalmanagementservices(Hooper). • 20.08to0.87mg/kg/infant(95.6%reduction) • WithOregonstatuterevisionaroundaccesstotreatmentservices thatprovidemedicallysupportedrecovery:someincreasedaccessto bestpracticesforwomen(butstillfarfar frommeetingtheneed especiallyforwomentakingmethadone).

@cccportland @cccportland DEPRESSION SCREENING Toll-free Helpline 800-944-4PPD UPDATES Support in English & Spanish Free Telephone Chat with an Expert WendyNDavis,PhD Online Support Groups Provider Consultation PostpartumSupportInternational PacificNWUpdateinObGyn and www.postpartum.net Women’sHealth 1-800-944-4PPD ThursdayNov14,2019 1-800-944-4773

www.postpartum.net2019 2 WWW.POSTPARTUM.NET2019

“YouCan’tTellbyLooking” PortlandAreaSupport

“Ifinallytoldmyhusbandthathe andmydaughterwouldbe betteroffwithoutme—thatI wasnotagoodmotherorwife. 1Ͳ800Ͳ557Ͳ8375 Ifeltlikethingswerenever [email protected] goingtogetbetter—thatI wouldneverfeelhappyagain. …“Iamgoingtoactasthough everythingisfineandIamterrified www.babybluesconntion.org Theonlywayoutwastodie.” ofwhatliesahead.”

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Doesprevalencewarrant WhyShouldWeScreen? screening?

• "Youcan’ttellbylooking” Gestational Hypertension, • Highprevalencerate 8% • Effectivescreeningandtreatmentsavailable PMADs,21% • Increasesrateofdetection PreͲeclampsia • SatisfiesWHOcriteriaforpopulationͲbasedscreening ,8% • Reducesrelativeriskofcontinueddepressionat3Ͳ5monthsby18Ͳ59% Gestational • RisksofuntreatedPMADsarewelldocumented Diabetes,8% (Learman,2018;Gjerdingern &Yawn,2007)

WWW.POSTPARTUM.NET2019 WWW.POSTPARTUM.NET2019 Wisneretal,2013;Nhibi.nih.go BarrierstoImplementation PMADStudyof10,000women

• Surveyofmorethan200physicians • 21%hadpostpartumdepression • Topbarrierstoscreening • 26.5%Ͳ beforepregnancywithmorechronicpattern • Timeconstraints • 33.4%Ͳ onsetinpregnancy • Inadequatetraining • 40.1%Ͳ onsetpostpartum • Lackofknowledgeofthediagnosticcriteria • Personalexperience(throughfriend,family,orself) associatedwithincreasedscreening Wisner KL, Sit DKY, McShea MC, et al. JAMA Psychiatry March 2013 JPsychosom Obstet Gynaecol.2011;32(1):27Ͳ34.

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PMADStudyof10,000women Prevention

Ofthosewhohadsymptoms… • 68.5%Ͳ unipolardepression Weknow: • 66%Ͳ comorbidanxietydisorders • Whoisatrisk • 22.6%Ͳ diagnosedwithbipolardisorder • Howtoscreen

• 19.3%Ͳ endorsedthoughtsofharmingthemselves • Howtorefer

• Wheretorefer Wisner KL, Sit DKY, McShea MC, et al. JAMA Psychiatry March 2013 • Reliabletreatmentmethods

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ScreeningRecommendations ACOGRedesignsPostpartumCare

TheU.S.PreventiveServicesTaskForce(USPSTF)recommendsscreening fordepressionamongadolescentsandadults,includingpregnantand • 2018Ͳ FourthTrimesterGuidelines postpartumwomen.TheAmericanCollegeof • ACOGPublishedcommitteeopinioncallingforhealthcare providerstoassistwomeninnavigatingthetransition frompreͲ topostpartumcare. ObstetriciansandGynecologists(ACOG)recommendsthatclinicians screenpatientsatleastonceduringpregnancyorthepostpartumperiod • Womenshouldhaveongoingcontact,startinginfirstthree fordepressionandanxietysymptomsusingastandardized,validatedtool. weekspostpartum. • FollowͲupvisitsasneeded,andacomprehensive postpartumvisitat12weeks. TheUSPSTFandACOGalsorecommendthatscreeningbeimplemented withadequatesystemsinplacetoensureaccuratediagnosis,effective Obstet Gynecol.2018;131(5):e140Ͳe150. treatmentandappropriatefollowͲup.

WWW.POSTPARTUM.NET2019 AmericanMedicalAssociation MaternalMentalHealthSafetyBundle

• 2017:Newpolicespromotingimplementationofaroutine TheCouncilonPatientSafetyinWomen’sHealthCare protocolfordepressionscreeningofperinatalwomen. https://safehealthcareforeverywoman.org • “Asattentionisturnedtowardthenewborn,thehealth andwellbeingofthemothercan,unfortunately,takea 1. Readiness (EveryClinicalCareSetting) backseat,evenaspreventablephysicalandmentalissues 2. Recognition&Prevention(EveryWoman) posedangers.WeneedtorecognizethatdangersofpostͲ 3. Response (EveryCase) partumdepressionandrecognizethatpregnancyͲrelated deathshavebeenincreasing,”AlbertJ.Osbahr III,MD 4. Reporting/SystemsLearning(EveryClinicalCare Setting)

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ProposedNewMeasuresforHEDIS® TimingRecommended 2020 1. Firstprenatalvisit NCQAproposedtwonewperinataldepressionmeasures 2. Atleastonceinsecond forHEDIS2020commercialandMedicaidhealthplan trimester reporting: 3. Atleastonceinthirdtrimester • PrenatalDepressionScreeningandFollowͲUp(PND) 4. TwoͲweekpostpartumvisit 5. SixͲweekpostpartumvisit • PostpartumDepressionScreeningandFollowͲUp 6. Repeatedscreeningat6and/or (PPD) 12monthsinOBandprimary caresettings

https://blog.ncqa.org/depressionͲmeasureͲmothers/ http://www.postpartum.net/learnͲ more/screening/

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CulturallySensitiveInterventions EvidenceBasedScreeningTools andInformedInteractions

Themostwellresearched • Interpretscreeningcautiously andvalidatedperinatal • Useeducationalprograms, measures: incorporatingappropriate • EdinburghPostnatal descriptionsandlanguage DepressionScale(EPDS) • Recognizeimpactof • PatientHealth discriminationandracism Questionnaire(PHQ)9 MargaretSpinelli,PecIndman,JohnCox,WendyDavis,and BirdieGunyonͲMeyeratthe2010PSIͲMarceMeeting • Provideculturallyinformedcare

WWW.POSTPARTUM.NET2019 WWW.POSTPARTUM.NET2019 EdinburghPostnatalDepressionScale ScreeningToolTips (EDPS)

• Makestandardpracticeforallfamilies. • Tenitemselfreport • Routinelygivewithotherpapersandformsfor Mothertofillout. • Scoreof>10isconsideredpositive • Shouldhaveawrittenintroductiononscreeningtool • Cutoffscorevariesbypopulation/culture orbeverballyexplainedpriortogivingtomother. Cox and Holden (1994) Perinatal Psychiatry: Use and Misuse of the • Score,review,anddocumentinstandardplaceon Edinburgh Postnatal Depression Scale. London: Gaskell office/hospitalforms/electronicdocument. January 2014 : Perinatal Mental Health:The EPDS Manual,(2nd edition), Cox, Holden,Henshaw • Havereferralplanand/orlistavailableforreferrals

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EdinburghPostnatalDepressionScale SampleLeadInStatementfor (EDPS) Screening

• Mostthoroughlyvalidated • Pleasebeasopenandhonestaspossiblewhenansweringthesequestions. • CosteffectiveͲ freetocopyiforiginalauthorscited • ItisnoteasybeinganewmotheranditisOKtofeelunhappyattimes.As youhaverecentlyhadanewbaby,wewouldliketoknowhowyouare • DesignedforPerinataluse feeling. • Validatedwithmanycultures • Pleasestatetheanswerwhichcomesclosesttohowyouhavefeltduringthe • Validatedwithteens,dads pastsevendays,notjusthowyouarefeelingtoday. • Validatedfortelephone • Easytoadministerandscore AdaptedfromRegisteredNursesAssociationofOntario • Availablein~60languages NursingBestPracticesGuidelines

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Name ______Baby䇻s EDC or Birthdate ______Today䇻s Date ______Please circle the answer that best describes how you have felt over the past 7 days. SeverityRangesfortheEPDS 1. I have been able to laugh and see the funny side 6. Things have been too much for me. of things. 3 Yes, most of the time I haven't been able to cope at all 2 Yes, sometimes I haven't been coping as well as usual 0 As much as I always could 1 No, most of the time I have coped well 1 Not quite so much now 0 No, I have been coping as well as ever 2 Not so much now 3 Not at all 7. I have been so unhappy that I have had 2. I have looked forward with enjoyment to things. difficulty sleeping. 0 As much as I ever did 3 Yes, most of the time • Noneorminimaldepression(0–6) 1 Somewhat less than I used to 2 Yes, sometimes 2 A lot less than I used to 1 Not very often 3 Hardly at all 0 No, not at all • Milddepression(7–13) Cutoffsmay 3. I have blamed myself unnecessarily when things 8. I have felt sad or miserable. went wrong. 3 Yes, most of the time varybetween10Ͳ12 2 Yes, quite often 0 No, not at all 1 Not very often 1 Hardly ever 0 No, not at all 2 Yes, sometimes • Moderatedepression(14–19) 3 Yes, very often 9. I have been so unhappy that I have been 4. I have been anxious or worried for no good crying. • Severedepression(19–30) reason. 3 Yes, most of the time 2 Yes, quite often 3 Yes, often 1 Only occasionally 2 Yes, sometimes 0 No, never 1 No, not much 0 No, not at all 10. The thought of harming myself has occurred to me. McCabeͲBeaneetal,2016 5. I have felt scared or panicky for no good reason. 3 Yes, quite often 3 Yes, often 2 Sometimes 2 Yes, sometimes 1 Hardly ever 1 No, not much 0 Never 0 No, not at all

WWW.POSTPARTUM.NET2019 PHQ9 PHQͲ9 Patient Name Date 1. Over the last 2 weeks, how often have you been bothered by any of the following problems? Read each item carefully, and circle your response. Not at all Several days More than half the days Nearly every day 0 1 2 3 1. Little interest or pleasure in doing things 2. Feeling down, depressed, or hopeless 3. Trouble falling asleep, staying asleep, or sleeping too much • Nineitemselfreportquestionnaire 4. Feeling tired or having little energy 5. Poor appetite or overeating • 6. Feeling bad about yourself, feeling that you are a failure, or feeling that you have let EasytoscoreandlinkedwithDSMdiagnosticcriteria yourself or your family down 7. Trouble concentrating on things such as reading the newspaper or watching television. • Canassesandtracktreatmentresponse 8. Moving or speaking so slowly that other people could have noticed. Or being so fidgety or restless that you have been moving around a lot more than usual 9. Thinking that you would be better off dead or that you want to hurt yourself in some • UsefulforbroadrangeofpatientsͲͲ developedfor way FamilyPractitioners Totals 2. If you checked off any problem on this questionnaire so far, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people? Not Difficult At All Somewhat Difficult Very Difficult Extremely Difficult 0 123

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PHQͲ2 PHQ-4 PHQ2Ͳ Shortversion Overthepast2weeks,howoftenhaveyoubeenbotheredbyanyofthe followingproblems? Littleinterestorpleasureindoingthings 0=Notatall 1=Severaldays 2=Morethanhalfthedays 3=Nearlyeveryday

Feelingdown,depressed,orhopeless 0=Notatall 1=Severaldays 2=Morethanhalfthedays 3=Nearlyeveryday

Totalpointscore:______

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ScreeningforBPSpectrum SuicideRiskQuestion

• www.psycheducation.orgͲ JimPhelps,MD ` Question#10onEPDSorPHQ:“Thethoughtofharmingmyselfhas occurredtome.” • MoodDisordersQuestionnaire(MDQ)isascreenfor BipolarI.Nowcopyrightedbyitsleadauthor ` Ifsheanswerswithanythingotherthan0,providermustfollowupto addressthreatofharm. • PrimaryCareMoodCheckͲ Phelps • Morecomprehensivescreeningtool ` Donotavoidquestionsthatareuncomfortable. • Willremaininthepublicsector(notcopywritten) • IntegratestheBipolarSpectrumDiagnosticScale,whichhashigherspecificitythan MDQ ` Assess,Refer,andFollowUp

29 WWW.POSTPARTUM.NET2019 30 WWW.POSTPARTUM.NET2019 LocateScreeningTools Apositivescorefromascreening toolindicatesaneedforfurther assessmentandreferral ƒ EPDS: www.fresno.ucsf.edu/pediatrics/downloads/edinburghscale.pdf Stepsafter Essentialfortheproviderto ƒ PHQs,GADͲ7,andtranslations:http://www.phqscreeners.com/ Screening facilitatecontinuityofscreening, ƒ PHQ2:http://health.utah.gov/rhp/pdf/PHQͲ assessment,referral,andtreatment 9%20two%20question.pdf ƒ PHQ4: www.psychiatrictimes.com/all/editorial/psychiatrictimes/pdfs/scaleͲ WHAT’SYOURALGORITHM? PHQ4.pdf ƒ MDQ:www.integration.samhsa.gov/images/res/MDQ.pdf Screening>Assessment>Refer>Tx ƒ PCMC:https://psycheducation.org/primaryͲcareͲproviderͲresourceͲ center/moodcheck/

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Nocosttothecaller PRIMARYCARETRAINING

PSIFrontlineProviderTraining(webinar) Firstnationalperinatal psychiatricconsultationline www.postpartum.net/professionals/trainingsͲ events/frontlineͲproviderͲtrainings/

Providedformedical ACOGWEBINAR professionals www.acog.org/WomensͲHealth/DepressionͲandͲPostpartumͲ Psychiatric Depression ConsultationLine Providerscalltomake appointmentwithaPSI perinatalpsychiatricexpert MCPAPFORMOMS– ToolkitsandAlgorithms https://www.mcpapformoms.org/

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Contact Information

Wendy Davis, PhD 503-277-3925 call or text [email protected]

Postpartum Support International 800-944-4773 helpline 503-894-9453 office www.postpartum.net Help Map www.postpartum.net/get-help/locations/

ZZZSRVWSDUWXPQHW Disclosures

• None

Postpartum Salpingectomy for Permanent Contraception and Cancer Risk Reduction PNW Update in Ob/Gyn and Women’s Health

DATE: November 14, 2019 PRESENTED BY: JESSICA REID, MD; Instructor and Family Planning Fellow

Objectives Pop Quiz! True or False

• Review methods of permanent contraception • A salpingectomy is the removal of the and fallopian tube etiology of ovarian cancer mid-section of the fallopian tube. • Understand current recommendations and practice patterns • Salpingectomy should be discussed with • Discuss literature regarding safety, feasibility, all women undergoing a tubal ligation. and cost-effectiveness of postpartum salpingectomy

Female Permanent Contraception • High mortality • No effective screening • • 2nd most common US contraceptive method 70% Tubal origin? • Surgical technique – Variable – Hysteroscopic – no longer available • Timing Prophylactic or – Interval Opportunistic Salpingectomy – Postpartum 2013 2015 2019 2013 2015 2019

Society of Gynecologic Society of Gynecologic Oncologists (SGO): Oncologists (SGO): Consider salpingectomy Consider salpingectomy at time of hysterectomy at time of hysterectomy or other pelvic surgery or other pelvic surgery to reduce ovarian to reduce ovarian cancer risk. cancer risk.

Salpingectomy Rates 2013 2015 2019 Pre/Post ACOG Guidelines 70 Society of Gynecologic American College of 60 Oncologists (SGO): Obstetricians and Consider salpingectomy Gynecologists (ACOG): 50 at time of hysterectomy “Although data are limited, postpartum 40 or other pelvic surgery salpingectomy and salpingectomy at the time of cesarean delivery appear feasible and to reduce ovarian safe.” 30 cancer risk. “The risks and benefits of salpingectomy 20 should be discussed with patients who desire permanent sterilization.” 10

Technique: remove fimbriated ends and 0 any fimbrial attachments to the ovary. 2013 2015 2017

Polen-De et al. Contraception. 2019.

Salpingectomy Rates by CPT and ICD Codes

CPT Codes

ICD Codes

Change from ICD-9 to ICD- • Northern Increased Rate of Salpingectomy 10 California from 2011-2016 Kaiser Database Vaginal Delivery including >10,000 Cesarean Section procedures

Interval

0 5 10 15 20 25 30 35 40 2014 2013 2016 2017 2015 Polen-De et al. Contraception. 2019. Powelletal.Obstet Gynecol.2017. 2011 2016 Salpingectomy Technique Is it feasible?

• Randomized control trial • Population: –Women undergoing C-section • Standard BTL: Partial salpingectomy • Complete bilateral salpingectomy • Primary Outcome – Mean total operative time – Completion rate

SubramaniamAetal.Obstet Gynecol.2018.

BTL Salpingectomy Primary Outcomes: Delivery BMI 39.4 +/- 7.4 38.8 +/- 10.0 H/o abdominal or 5% 8% • Mean total operative time: salpingectomy 15 min longer pelvic surgery • Completion: salpingectomy less successful 68% vs 95% # of prior 2.0 +/- 1.0 2.0 +/- 0.8 cesareans Cesarean type Secondary Outcomes: Primary 18% 3% Repeat 83% 98% • Mean tubal operative time: salpingectomy 12 min longer Skin incision • Median EBL for tubal procedure: higher in Vertical 8% 18% salpingectomy group 10cc [5-25] vs. 5cc [5-10] Pfannenstiel 93% 83% • No adverse outcomes in either group Of those where salpingectomy was assigned, but not completed: • Higher BMI (46 vs 36) • Longer time from skin to tubal start (18 minutes)

Surgeon Satisfaction & Attitudes Conclusions

BTL Salpingectomy Satisfied with 92% 62% • 15 minutes extra operative time feasibility Satisfied with safety 97% 53% • Safe • 2/3rds successful completion

• Similar findings in other studies If we think salpingectomy is a safe and feasible alternative… – Do the benefits outweigh • Theoretic cohort of women undergoing cesarean the risks? delivery who desired permanent contraception – Is it cost effective? – Bilateral tubal ligation – Bilateral opportunistic salpingectomy – Postpartum LARC (baseline reference group)

• Examined clinical outcomes and cost-effectiveness

VenkateshKKetal.AmJObstet Gynecol.2019.

Assumptions

Operative complications: – Absolute baseline risk 6.9% • BTL: + 10 minutes = 7.6% • Salpingectomy: + 20 minutes = 8.3% Pregnancy outcomes (unintended / ectopic): 422 252770 20 57 – BTL: 0.45% risk pregnancy / 20% ectopic – Salpingectomy: 0.38% risk pregnancy / 10% ectopic Ovarian cancer: – Absolute baseline risk 1.28% • BTL: 34% risk reduction • Salpingectomy: 64% risk reduction

Is there a preferred strategy? Cost Effectiveness • 49% chance that BTL is the preferred strategy • BTL procedure is cost-saving $64 • Both BTL and salpingectomy have favorable cost • If salpingectomy complication risk is > 2% higher effectiveness ratios. than BTL • Salpingectomy is more cost effective for outcomes of OR contraception and ovarian cancer risk reduction. • If cancer risk reduction of salpingectomy is <52%

THEN • Bilateral tubal ligation is the preferred strategy. Conclusions Summary

• BTL and Salpingectomy are both cost-effective • No evidence of short-term (peri-operative) risk or strategies for permanent contraception and ovarian long-term risk with salpingectomy. cancer risk reduction. • Salpingectomy appears to be safe and feasible at time of cesarean section, though operative time may be increased. • Risks and benefits of salpingectomy with cesarean • Limited data exists regarding salpingectomy the delivery need to be better defined before a preferred time of post-partum tubal (after vaginal delivery). strategy can be determined. • Benefits include contraceptive efficacy and ovarian cancer risk reduction. • Appears to be cost-effective • Some questions still remain…

Considering postpartum salpingectomy in your practice?

• Discuss options during prenatal care Questions? – Benefits of BTL and salpingectomy: contraception and ovarian cancer risk Jessica Reid MD – Risks: increased operative time, regret, inability to Instructor OB/GYN & Family Planning Fellow complete procedure • Consider patient specific risks/surgical difficulty [email protected] • Develop a standardized technique and consider implementing a training plan • Choose method based on intraoperative findings

CPT Codes:

• At time of cesarean section: • Direct referrals: 503-418-4500 – 58611: ligation or transection of fallopian tube(s) done at the time of cesarean delivery or intra-abdominal surgery. • Questions/Consults: 1800-245-6478 – 58700: Salpingectomy, complete or partial, unilateral or bilateral (separate procedure) • Routine & Complex Family Planning Care • At time of laparoscopy: – Outpatient clinic sessions M-Th – 58670: laparoscopy surgical; with fulguration of oviducts – 3 outpatient moderate sedation clinics + OR time (With or without transection). This was developed specifically for reporting a laparoscopic elective – Multi-disciplinary (Heme+Gyn) clinics for Women & sterilization. Girls with heavy menstrual bleeding – 58661: laparoscopy surgical with removal of adnexal – Center of Experience in Deep Implant Removals structures. This should be used when a disease process is involved (adnexal mass, paratubal cyst, etc). Should we be routinely References

performing salpingectomy during • ACOG Committee Opinion #774: Opportunisitic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention; April 2019. • Chene G, Rahimi K, Mes-Masson A, Provencher D. Surgical implications of the potential new cesarean deliveries? tubal pathway for ovarian carcinogenesis. Journal of minimally invasive gynecology. 2013;20:153-9. “Ultimately, the value of salpingectomy requires more • Danis RB, Della Badia CR, Richard S. Postpartum Permanent Sterilization: Could Bilateral Salpingectomy Replace Bilateral Tubal Ligation? J Min Invasive Gyn 2016; 23(6) 928-932). study to accurately balance the risks including • Deshpande NA et al. relationship between body mass index and operative time in women complications, cost, surgical time, lack of reversibility, receiving immediate postpartum tubal ligation. Contraception 2019; 100:106-110. • Dilley SE, Havrilesky LJ, Bakkum-Gamez J, Cohn DE, Straughn Jr JM, Caughey AB, et al. Cost- and potential effect on ovarian reserve against the effectiveness of opportunistic salpingectomy for ovarian cancer prevention. Gynecol Oncol. 2017;146:373-9. benefits, including a higher rate of sterilization, lower • Ganer Herman H, Gluck O, Keidar R, Kerner R, Kovo M, Levran D, et al. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: A randomized trial. Am J Obstet reoperation rates, and, most importantly, the Gynecol. 2017;217:472.e1,472.e6. • Garcia C, Moskowitz OM, Chisholm CA, Duska LR, Warren AL, Lyons GR, et al. Salpingectomy comparative reduction in ovarian cancer offered by compared with tubal ligation at cesarean delivery: A randomized controlled trial. Obstet salpingectomy over tubal occlusion.” Gynecol. 2018;132:29-34. • Guttmacher Fact Sheet: Contraceptive Use in the United States, July 2018. https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states

Powelletal.Obstet Gynecol.2017.

References Questions?

• Kurman RJ, Shih I. Molecular pathogenesis and extraovarian origin of epithelial ovarian cancer—shifting the paradigm. Hum Pathol. 2011;42:918-31. Contact me • Medeiros F, Muto MG, Lee Y, Elvin JA, Callahan MJ, Feltmate C, et al. The tubal fimbria is a preferred site for early adenocarcinoma in women with familial ovarian cancer syndrome. Am J Surg Pathol. 2006;30:230-6. • Polen-De C, et al. Nationwide salpingectomy rates for an indication of permanent contraception OHSU Physician Advice & Referral Service before and after published practice guidelines. Contraception 2019; 100:111-115. •503-494-4567 • Powell C et al. Salpingectomy for Sterilization: Change in Practice in a Large Integrated Health Care System, 2011-2016. 2017 Obstet Gynecol. 130(5):961-967. •800-245-6478 (toll-free) • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA: a cancer journal for clinicians. 2015;65:5-29. • Subramaniam A, et al. Feasibility of Complete Salpingectomy Compared with Standard Postpartum tubal Ligation at Cesarean Delivery A Randomized Controlled Trial. Obstet Gynecol 2018; 132(1):20-27. • Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath III CA, et al. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019;152:127-32 • Venkatesh KK, Clark LH, Stamillo DM. Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery. Am J Obstet Gynecol 2019;220:106e1-10. PerinatalOpiateTreatmentOptionsandHotTopics: • ScopeofissueinOregon • Methamphetamines • Treatmentoptions • Benefitsoftreatment • Withdrawal:risky? OpioidTreatmentOptions&HotTopics: • Syndemic:syphilis,HIV,HCV ApproachestoPerinatalSubstanceUseDisorder • HCVtreatment

PacificNWUpdateinOb/Gyn andWomen’sHealth11/14/19

AmandaRisserMDMPH,Sr.MedicalDirectorofSubstanceUseDisorderServices

@cccportland @cccportland

Oregon:worseprevalence,worseaccesstotreatment

@cccportland @cccportland

DramaticREGIONALvariationinusepatterns:

@cccportland @cccportland NORTHEASTUnitedStates NATIONWIDEDATA

@cccportland @cccportland

TreatmentisEffective:someperspective

Perinatalintervention Outcome

Prevention of RDS NNT 11 NNH 8 (high Antenatal Steroids Prevention of need for surfactant NNT 9 sugar) Prevention of IVH NNT 9

Prevention of preeclampsia: high risk Aspirin NNT 50 WESTERNUnitedStates patients

Prevention of preterm birth before 34 NNT 22-80 Progesterone wks w prior h/o spontaneous preterm NNH 63-167 NNT 7-9.1 birth

Acamprosate Total Abstinence NNT 12 Alcohol Use Disorder Naltrexone Total Abstinence NNT 20 Naltrexone Zero Heavy Drink NNT 12

Retention in Treatment (proxy for Buprenorphine NNT 2-4 decreased use)

@cccportland @cccportland

PharmacotherapyforOpiateUseDisorder:

TwocommonformulationsͲ Suboxone:buprenorphine/naloxone Subutex:buprenorphine

@cccportland @cccportland BenefitsofPharmacotherapyforOUDinpregnancy: Opiatewithdrawalinpregnancy?

• Less likely to die. • Less likely to be incarcerated. • Less likely to have injection associated infectious diseases (HIV, HCV, HBV, cellulitis, endocarditis). • Less likely to have small and/or early babies. • More likely to be employed and stably housed. • Less likely to have psychiatric symptoms. • More stable family and social life. • More likely to obtain abstinence.

BellJ,TowersCV,HennessyMD,et al.Detoxificationfromopiatedrugsduringpregnancy. 13 @cccportland 14 @cccportland AmJObstet Gynecol 2016;215:374.e1Ͳ6.

Detox:harmfultofetus? RetrospectiveAnalysis,comparisonbetween4groups:

• Based on two case-reports from the 70s. • Group 1: incarcerated patients, involuntary acute detox w/o MAT • Subsequent studies have called this into question. • Group 2: inpatient detox with buprenorphine with intensive • This fear of harm has guided treatment for behavioral treatment decades. • Group 3: inpatient detox with buprenorphine without intensive • There are other reasons to feel an urgency behavioral treatment around treatment of withdrawal symptoms than • Group 4: outpatient SLOW taper/detox over 8-16 weeks. fetal harm. BellJ,TowersCV,HennessyMD,et al.Detoxificationfromopiatedrugsduringpregnancy. BellJ,TowersCV,HennessyMD,et al.Detoxificationfromopiatedrugsduringpregnancy. AmJObstet Gynecol 2016;215:374.e1Ͳ6. AmJObstet Gynecol 2016;215:374.e1Ͳ6.

15 @cccportland 16 @cccportland

NASrateandrelapserate: Fetal/PregnancyOutcomes

Group 1 2 3 4 “With our 301 study patients and the patients reported in jail detox+BH detoxͲ BH slowtaper these 5 follow-up studies, more than 600 patients have RateofNAS 20 (18.5%) 4(17.4%) 54(70.1%) 16(17.2%) N(%) undergone detoxification during pregnancy, with no report of intrauterine fetal demise or preterm delivery

RateofRelapse 25(23.1%) 4(17.4%) 57(74%) 21(22.5%) related to the process.” N(%)

BellJ,TowersCV,HennessyMD,et al.Detoxificationfromopiatedrugsduringpregnancy. BellJ,TowersCV,HennessyMD,et al.Detoxificationfromopiatedrugsduringpregnancy. AmJObstet Gynecol 2016;215:374.e1Ͳ6. AmJObstet Gynecol 2016;215:374.e1Ͳ6.

17 @cccportland 18 @cccportland ThearticleleadstorevisedACOGguidance: Contextisimportant:

• 2014:Tennesseepasseda“fetalassaultlaw”,womenwhosebabies “If a woman does not accept treatment with an opioid agonist, or werediagnosedwithNOWwereincarcerated. treatment is unavailable, medically supervised withdrawal can be • WomenwereverymotivatedtominimizeriskofNOWfortheirinfants. considered under the care of a physician experienced in perinatal • AlsoͲ group1wasincarceratedandhadnochoicebecauseofthelack addiction treatment and with informed consent; however, to be ofaccesstoMSRwhileincarcerated. • successful, it often requires prolonged inpatient care and Whilethelawsawits“sunset”in2016thiswasthecontextinwhich theretrospectivedatawasaccumulating. intensive outpatient behavioral health follow up.” • WomenreceivedintensiveBHtreatmentwhichisn’tsustainable. • (ACOG committee opinion August 2017)

BellJ,TowersCV,HennessyMD,et al.Detoxificationfromopiatedrugsduringpregnancy. AmJObstet Gynecol 2016;215:374.e1Ͳ6.

19 @cccportland @cccportland

“Our idea is to get the girls off drugs before delivery, then equip them to • Syndemic:twoormoreepidemicsoccurring be better moms,” Thomas said. “We simultaneouslythatinteractandexacerbate could save the state lots of money, theburdenofdisease. • TencongenitalsyphiliscasesinOregonin and save the babies the anguish of 2018:upfromaverylowincidenceprior. withdrawal for six weeks.” • Alldrivenbyinjectiondruguse(esp meth) andbehaviorswhicharecoͲoccurring (oneoftheauthorsquotedinNBCnews)) (condomless sex,transactionalsex,sexw mult partners).

21 @cccportland @cccportland

ReferyourpatientstoLOWBARRIERHCVtx: • Whileinterventionstopreventvertical transmissionofHCVarenotbackedbystrong evidence,generalapproachis: • AvoidFSEunlessbenefits>risks • AvoidAROM,worktominimizelengthoftimethat membranesruptured • Until2019,Medicaidpatientscouldn’treceive medicationsforHCVtreatmentunlessthey were:sober,hadliverdamage. • Thisexcludedreproductiveagewomen! • Now:nosobrietyorliverdamage requirementsforpriorauthorizationstoget treatment!Getyourpatientstoaplacethat willtreatthem!OrTREATTHEMYOURSELF!

@cccportland Depression in Ob/Gyn Settings

• Women are twice as likely as men to develop depression (Albert, 2015)

• Several gynecological conditions are associated with depressive symptoms:

o Premature ovarian insufficiency (Schmidt et al., 2016)

o Polycystic ovarian syndrome (Deeks, Gibson-Helm, & Teede, 2010)

o Stillbirth (Hogue et al., 2015) Cognitive Behavioral o Endometriosis (Chen et al., 2016)

Therapy for Depression • 11% of ob/gyn visits – depression is chief complaint (Crimele et al, 2013) o Additional 30% of ob/gyn visits – pt mentions psychological Teni Davoudian, PhD, ABPP November, 14, 2019 distress (depressed mood, anxiety, stress) Clinical Psychologist Assistant Professor of Psychiatry 2

CBT: Treatment Outcome Research Theoretical Underpinnings of CBT

• CBT reduces depressive symptoms and/or increases quality of • “People are not disturbed by things but by the view they take of life and/or improves medical treatment outcomes: them.” –Epictetus

o Perimenopause (Green et al., 2013) • Psychopathology is (partially) the result of faulty information o Infertility (Domar et al., 2000) processing o Pregnancy and postpartum (Sokol, 2015)

o COPD (Fritzche, Clamor, & von Leupolt, 2011) • Cognitions, emotions, and behaviors are interrelated o Cancer (Hart et al., 2012)

o Chronic pain (Edhe, Dillworth, & Turner, 2014) • Cognitions are modifiable o Irritable bowel syndrome (Li et al, 2014)

3 4

Event/Situation

5 6 Structure of CBT Behavioral Activation

• Short-term psychotherapy (approximately 6-12 sessions) • Increases patient activity (re-introduction to abandoned activities or o Booster sessions may be needed introduction to new activities)

• Psychoeducation • Improves self-efficacy and increases exposure to reinforcing situations • Goal-oriented

• Home practice o Homework facilitates generalization and maintenance of skills learned during therapy session

• Mechanisms of action: Activities Mood • Behavioral activation • Cognitive Restructuring

7 8

Behavioral Activation Cognitive Distortions

• Questions to ask patient: o What do you miss doing? • Inaccurate, inflated, irrational thoughts or beliefs that distort our perceptions of reality o What did you used to do? o What did you want to try but never had the chance to? • Negative views of the self, world, or future o Who do you enjoy spending time with? • Distorted automatic thoughts • If pt cannot come up with an answer, provide list of pleasurable o Cognitions that come to mind involuntarily and effortlessly activities o Create feelings of failure, inadequacy, and disempowerment

• In order to reframe/restructure distorted cognitions, we must first identify them as such

9 10

Cognitive Restructuring Cognitive Restructuring

• Dispute cognitive distortions • What type of cognitive error • Thoughts are not facts is the statement below? o “Now that I have a baby, I • Evidence for and against thoughts never sleep” o What is the evidence that this thought is true?

• How can it be restructured? • Pros and cons of holding onto thoughts o What are the emotional costs of holding on to this thought?

• Helps us to slow down and develop alternative/balanced thought

11 12 Introducing CBT to Patients CBT Training for Physicians 1. Present cognitive triangle (thoughts, emotions, behaviors are interrelated) • CBT-trained physicians incorporated some CBT techniques into practice 6 months after training (Wieber & Griever, 2005) 2. Describe goal of CBT: develop balanced thinking and establish helpful behaviors • Main barriers for physicians: o Lack of time 3. Decide whether to start with cognitions or behaviors o Limited confidence in methods o Interruptions o Pt preferences for pharmacotherapy Cognitive Route Behavioral Route

• Cognitive distortions form • List of pleasurable • Beck Institute for Cognitive Behavior Therapy offers on-site activities • Thought log and off-site training programs to teach CBT skills. • Activity scheduling calendar

13 14

Self-Administered CBT for Patients Final Thoughts

• Apps • Medical providers play an integral role in managing depression o Cognitive Diary CBT Self-Help

o CBT Thought Record Diary • CBT is an accessible modality of psychotherapy in medical settings o What’s Up ƒ Pilot studies suggest effectiveness • CBT can be utilized while waiting for antidepressants to take effect of internet-based/computerized CBT

for depression (Khatri et al., 2014) • CBT may not be appropriate for pts with: o Thought disorders • Books o Limited intellectual functioning (consider behavioral focus) o Feeling Good: The New Mood Therapy

by David Burns, MD • Psychodynamic, interpersonal therapy, acceptance commitment

o Mind Over Mood: Change How You Feel By Changing How You Think therapy are as effective as CBT (Beltman et al., 2010; Cujipers et al., 2010; Tolin, 2010) by Dennis Greenberger, PhD and Christine Padesky, PhD

15 16

Green, S. M., Haber, E., McCabe, R. E., & Soares, C. N. (2013). Cognitive–behavioral group treatment for References menopausal symptoms: A pilot study. Archives of women's mental health, 16, 325-332.

Albert, P. R. (2015). Why is depression more prevalent in women?. Journal of psychiatry & neuroscience: Gulliksson, M., Burell, G., Vessby, B., Lundin, L., Toss, H., & Svärdsudd, K. (2011). Randomized controlled JPN, 40(4), 219. trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project Butler, A. C., Chapman, J. E., Forman, E. M., & Beck, A. T. (2006). The empirical status of cognitive- (SUPRIM). Archives of internal medicine, 171(2), 134-140 behavioral therapy: a review of meta-analyses. Clinical psychology review, 26(1), 17-31. Hart, S. L., Hoyt, M. A., Diefenbach, M., Anderson, D. R., Kilbourn, K. M., Craft, L. L., ... & Spring, B. Cerimele, J. M., Vanderlip, E. R., Croicu, C. A., Melville, J. L., Russo, J., Reed, S. D., & Katon, W. (2013). (2012). Meta-analysis of efficacy of interventions for elevated depressive symptoms in adults Presenting symptoms of women with depression in an obstetrics and gynecology setting. Obstetrics and gynecology, 122(2 0 1), 313. diagnosed with cancer. Journal of the National Cancer Institute, 104(13), 990-1004.

Chen, L. C., Hsu, J. W., Huang, K. L., Bai, Y. M., Su, T. P., Li, C. T., ... & Chen, M. H. (2016). Risk of developing Hofmann, S. G., Asnaani, A., Vonk, I. J., Sawyer, A. T., & Fang, A. (2012). The efficacy of cognitive major depression and anxiety disorders among women with endometriosis: A longitudinal follow-up behavioral therapy: A review of meta-analyses. Cognitive therapy and research, 36(5), 427-440. study. Journal of affective disorders, 190, 282-285. Deeks, A. A., Gibson-Helm, M. E., & Teede, H. J. (2010). Anxiety and depression in polycystic ovary Hogue, C. J., Parker, C. B., Willinger, M., Temple, J. R., Bann, C. M., Silver, R. M., ... & Reddy, U. M. (2015). syndrome: a comprehensive investigation. Fertility and sterility, 93(7), 2421-2423. The Association of Stillbirth with Depressive Symptoms 6–36 Months PostǦDelivery. Paediatric and perinatal epidemiology, 29(2), 131-143. Domar, A. D., Clapp, D., Slawsby, E., Kessel, B., Orav, J., & Freizinger, M. (2000). The impact of group psychological interventions on distress in infertile women. Health Psychology, 19(6), 568. Khatri, N., Marziali, E., Tchernikov, I., & Shepherd, N. (2014). Comparing telehealth-based and clinic- based group cognitive behavioral therapy for adults with depression and anxiety: a pilot study. Clinical Ehde, D. M., Dillworth, T. M., & Turner, J. A. (2014). Cognitive-behavioral therapy for individuals with interventions in aging, 9, 765 chronic pain: efficacy, innovations, and directions for research. American Psychologist, 69(2), 153

Fritzsche, A., Clamor, A., & von Leupoldt, A. (2011). Effects of medical and psychological treatment of depression in patients with COPD–a review. Respiratory medicine, 105(10), 1422-1433.

17 18 Questions? Li, L., Xiong, L., Zhang, S., Yu, Q., & Chen, M. (2014). Cognitive–behavioral therapy for irritable bowel syndrome: A meta-analysis. Journal of psychosomatic research, 77(1), 1-12. Contactme Sharry, J., Davidson, R., McLoughlin, O., & Doherty, G. (2013). A service-based evaluation of a therapist- supported online cognitive behavioral therapy program for depression. Journal of medical Internet research, 15(6), e121.

Li, L., Xiong, L., Zhang, S., Yu, Q., & Chen, M. (2014). Cognitive–behavioral therapy for irritable bowel OHSUPhysicianAdvice&ReferralService syndrome: A meta-analysis. Journal of psychosomatic research, 77(1), 1-12. • 503Ͳ494Ͳ4567 Sharry, J., Davidson, R., McLoughlin, O., & Doherty, G. (2013). A service-based evaluation of a therapist- • 800Ͳ245Ͳ6478(tollͲfree) supported online cognitive behavioral therapy program for depression. Journal of medical Internet research, 15(6), e121.

Schmidt, P. J., Cardoso, G. M., Ross, J. L., Haq, N., Rubinow, D. R., & Bondy, C. A. (2006). Shyness, social anxiety, and impaired self-esteem in Turner syndrome and premature ovarian failure. Jama, 295(12), 1373-1378.

Sockol, L. E. (2015). A systematic review of the efficacy of cognitive behavioral therapy for treating and preventing perinatal depression. Journal of Affective Disorders, 177, 7-21.

Thank You 19 Disclosures:

• None

Endometrial Cancer Prevention, Diagnosis, & Work-up

DATE: Nov 14, 2019 PRESENTED BY: Amanda S. Bruegl, MD MS

Uterine vs Endometrial Cancer Objectives

• Understand epidemiology and risk factors of endometrial cancer • Discuss prevention strategies in high risk patients • Discuss clinical assessment of abnormal uterine bleeding in premenopausal and postmenopausal women • Discuss work-up strategy while awaiting referral to gynecologic oncologist

www.medscape.com

Basic epidemiology of endometrial cancer

- Endometrial cancer is most common gynecologic malignancy in developed nations Epidemiology and Risk Factors -4th most common malignancy among women in both the U.S. and Canada

- 70% of women will be diagnosed with Stage I disease

- Mean age of diagnosis is 63 Normal Bleeding Pattern in Cycling Risk Factor: Unopposed Estrogen Women

EP

*** Unopposed estrogen can crease risk for endometrial cancer 10-20X

Risk Factor: Obesity Risk Factor: Tamoxifen

BreastTissue:AntiͲEstrogen Androgen Sex Hormone Binding Globulin Insulin Tamoxifen

aromatase EndometrialTissue:ProͲEstrogen Bioavailable Estrogen Estrone Tamoxifen results in a 3-fold increase in risk for EC

Development of EC can occur after discontinuation of Tamoxifen

RISK Factor: Hereditary Risk Risk Factor: Hereditary Risk

Lynch Syndrome (HNPCC) DNA MMR System Lynch Syndrome (HNPCC) • Colonoscopy at age 20-25 every 1-2 y, or 2-5 yrs prior 5’ A 3’ • Autosomal-dominant 3’ G 5’ to earliest colon cancer if before age 25 hereditary cancer syndrome • Consider upper endoscopy every 3-5 y at age 30-35.

MSH2 MSH6 Consider testing/treating H. pylori • Characterized by an increased 5’A 3’ • Consider annual urinalysis starting age 30-35 (if prevalence of endometrial and 3’ G 5’ colorectal cancer MSH2 mutation or FH of urothelial ca) • Consider annual physical/neurological exam starting • Germline mutations in the MSH2 MSH6 age 25-30 DNA mismatch repair (MMR) 5’A 3’ 3’ G 5’ • CA125 and US at clinician’s discretion* genes constitute the genetic MLH1 PMS2 basis for Lynch Syndrome • Consider EMB q1-2 years starting age 30

5’ A 3’ • Risk-reducing hyst, BSO ~age 40 3’ T 5’ Risk Factor: Other

RiskFactor RelativeRisk ACOG/SGO IncreasingAge 2Ͳ3 Practice Bulletin No 149, April ResidencyinNorthAmericaor 3Ͳ18 2015 NorthernEurope Higherlevelofeducationor 1.5Ͳ2 income Prevention WhiteEthnicity/Race 2 Nulliparity 3 HistoryofInfertility 2Ͳ3 MenstrualIrregularities 1.5 UnopposedEstrogen 10Ͳ20 Tamoxifen Use 2Ͳ3 Obesity 2Ͳ5 Diabetes,HTN,Gallbladder 1.3Ͳ3 disease,thyroiddisease Lynch Syndrome 22Ͳ50%lifetimerisk

Assessment of cycles at

Endometrial polyps/fibroids/hyperplasia well-woman visits Mullerian Agenesis BrainTumors

AbnormalKaryotype(45X;46 OvarianInsufficiency(Fragile XY) X) • Timing, intermenstrual bleeding, CervicalDysplasia/Cancer Menstrual PID/Cervicitis duration, presence of clots Cycle • Contraception? Hypothyroidism PCOS • Any changes in bleeding pattern? AdrenalDysfunction EndometrialCancer (congenitaladrenal hyperplasia)

Hyperprolactinemia Androgensecretingtumors • Bleeding, of any volume, after menopause?

The Menstrual Years: Abnormal Uterine Bleeding Normal Menstruation

NormalMenstrualCyclesinthe matureHPOAxis Structural NonͲStructural Cycleinterval 21Ͳ35days Menstrual flowlength 5daysorless COEIN Menstrualproductuse 3Ͳ6pads/tampons perday PALM C:Coagulopathy(vWD,coumadin) P:Polyps O:OvulatoryDysfunction A:Adenomyosis E:Endometrial L:Leiomyoma I:Iatrogenic/Infection M:Malignancy/Hyperplasia N:NOS Abnormal Uterine Bleeding – Ovulatory Dysfunction Ovulatory Dysfunction and Abnormal Uterine Bleeding – Regulating Cycles

AgeRange OptionstoRegulate Physiologic Iatrogenic Pathologic 13Ͳ18 OCPs 19Ͳ39 OCPs,Progesterone containingIUD,Weightloss andExercise Lactation HypothalamicDysfunction Chemotherapy Adolescence PrimaryPituitaryDisease 40Ͳmenopause Cyclicprogesterone, Radiation Pregnancy Hyperprolactinemia progesterone containingIUD, Surgery Perimenopause Thyroiddisease OCPs PCOS ACOG practice bulletin on Bleeding due to Anovulation CongenitalAdrenalHyperplasia AndrogenSecretingTumors PrematureOvarianInsufficiency

Abnormal Uterine Bleeding – When to Biopsy

• Endometrialbiopsyif: AgeRange EC Risk Evaluation of Abnormal Bleeding – Age45orolder 13Ͳ19 0.2/100,000 – Age35withRFforEC 20Ͳ34 1.6% – Notrespondingto 35Ͳ44 6.2% hormonalregulation 40Ͳmenopause 13Ͳ24/100,000 ACOG practice bulletein on Bleeding due to Anovulation – Anypointaftermenopause

Abnormal Uterine Bleeding – What is in a biopsy? Hysteroscopy

• EMBsamples~4%oftheendometrialcavity

• Sensitivityfordetectingabnormalities – EMB:68% – Hysteroscopy,D&C:78% Abnormal Uterine Bleeding – How often to biopsy?

• Persistentorrecurrentbleedingneedstobe evaluated

• TVUSasanadjunctivetool – Premenopausal • ProliferativePhase:EMS=4Ͳ8mm • SecretoryPhase:EMS=8Ͳ14mm – Postmenopausal • EMSч4mm

Postmenopausal bleeding

EMB TVUS I Diagnosed Cancer…. Now What?

ч4mm: Benign CAHorCancer Observe >4mm:EMB withEMBif recurs

Reassuring Facts to Share with What if it’s not reassuring? Patients with Grade 1 EMB

Stage Distribution 5yr Survival • I(Uterus) 73% 86% If EMB shows clear cell, uterine serous, or grade 3 endometrioid histology II(Cervix) 12% 66% III(Pelvisand 12% 44% – More aggressive histology that can be associated LymphNodes) with advanced disease or higher risk of IV (Upper 3% 16% recurrence abdomen/Lungs) • Symptoms or imaging suggestive of advanced disease • Many women require no treatment after surgery, others will have radiation to pelvis or vaginal cuff to decrease risk – Changes in bowel/bladder habits of recurrence – Pelvic pressure – Early satiety Endometrial Cancer: How can I help move things An Opportunity to Improve Wellness forward for my patient?

- Most women do not die of endometrial cancer but of the comorbidities that often coincide with the • Referral to gynecologic oncologist disease • Preoperative risk assessment (EKG, labs, etc) • If high risk (high grade biopsy, serous, clear BMI Risk of Death cell): obtain CT C/A/P with IV and po contrast 24-30 2.53 • If serous, add CA125 to labs 35-40 2.77 > 40 6.25

- Only 42% of women with endometrial cancer were aware of how weight related to diagnosis and post treatment prognosis

Take Home Messages Questions? Contact me

OHSU Physician Advice & Referral Service •503-494-4567 •800-245-6478 (toll-free)

Thank You Disclosures

• No relevant disclosures or conflict of interest

Neonatal [and beyond] Effects of Opioids 43rd Annual Pacific Northwest Update in Ob-Gyn and Women’s Health

November 14, 2019 Dmitry Dukhovny, MD MPH Associated Professor of Pediatrics 2 Oregon Health & Science University

Neonatal Opioid/Opiate Exposure Objectives

• Incidence • Different terminology:

– Neonatal Abstinence Syndrome (NAS) • Neonatal Effects of Opioids – Neonatal Opioid Withdrawal (NOW) • Management of neonates (and their families) • Neonates are born “dependent” not “addicted” to opioid/opiates

3 4 Image from https://www.vumc.org/nas/what-neonatal-abstinence-syndrome, accessed 10/22/2019

From: Neonatal Abstinence Syndrome and Associated Health Care Expenditures: United States, 2000-2009 From: Neonatal Abstinence Syndrome and Associated Health Care Expenditures: United States, 2000-2009

Patrick SW et al. JAMA. 2012;307(18):1934-1940. doi:10.1001/jama.2012.3951 Patrick SW et al. JAMA. 2012;307(18):1934-1940. doi:10.1001/jama.2012.3951

Figure Legend: NAS indicates neonatal abstinence syndrome. Error bars indicate 95% CI. P for trend < .001 over the study period. The unweighted sample sizes for rates of NAS and for all other US hospital births are 2920 and 784 191 in 2000; 3761 and 890 582 in 2003; 5200 and 1 000 203 in 2006; and 9674 and 1 113 123 in 2009; respectively.

Copyright © 2012 American Medical Copyright © 2012 American Medical Association. All rights reserved. Association. All rights reserved. Incidence of NAS by primary payer Proportion of birth-related hospital costs due to NAS among infants who were enrolled in Medicaid

Tyler N.A. Winkelman et al. Pediatrics 2018;141:e20173520 Tyler N.A. Winkelman et al. Pediatrics 2018;141:e20173520

©2018 by American Academy of Pediatrics ©2018 by American Academy of Pediatrics

Incidence of NAS From: Association Among County-Level Economic Factors, Clinician Supply, Metropolitan or Rural Location, and Neonatal Abstinence Syndrome

Patrick SW et al. JAMA. 2019;321(4):385-393. doi:10.1001/jama.2018.20851

Figure Legend: County Variation in Neonatal Abstinence Syndrome (NAS) per 1000 Hospital Births and 10-Year Moving Average Unemployment Rate for 2015Data are from an analysis of the Healthcare Cost and Utilization Project’s State Inpatient Databases, the Tennessee All-Payer Database, and the Health Resources and Services Administration Area Health Resources Files. aData from New York are from 2014, which is the most recent year available.

Copyright 2019 American Medical Association. 9 Figure from Ko et al. MMWR 2016 Aug 12; 65 (31) All Rights Reserved.

Neonatal Signs and Symptoms

• Neurologic Excitability

Neonatal (and • Gastrointestinal dysfunction

beyond) Effects of • Other systemic signs Opiates and Opioids

11 12 Hudak et al. “Neonatal Drug Withdrawal”. Pediatrics 2012. Neurologic Excitability GI Dysfunction

• Increased muscle tone • Vomiting, diarrhea

• Tremors • Poor/uncoordinated feeding

• Difficult to console –Poor weight gain/failure to thrive

• High Pitch Cry –Dehydration • Hyperactive DTRs –Increased caloric demand • Exaggerated moro reflex

• Frequent yawning and sneezing

• Seizures (rare – some studies site 2-11%) 13 14

Timing and Types of Symptoms Vary Systemic Signs

• Temperature instability/fever • Type of opiate/opioid

• Increased sweating • Last use

• Nasal stuffiness • Placental transfer

• Tachypnea • Maternal metabolism

• Poly-substance use (including alcohol and nicotine)

15 16

Poly-substance use Withdrawal Onset (and Monitoring)

• 24-48 hours for short acting (e.g. heroin, oxycodone)

– Minimum observation 3 days (AAP)*

• Typically >48 hours for long acting (e.g. methadone, OxyContin)

– Minimum observation 5-7 days (AAP)*

• Can last up to 14 days (although typically 5-7 days)

– Both instances after the typical discharge of a healthy newborn

• Preterm infants tend not to have as many signs and symptoms

*American Academy of Pediatrics (AAP) 17 Table 2 from Hudak et al. “Neonatal Drug Withdrawal”. Pediatrics 2012. 18 Hudak et al. “Neonatal Drug Withdrawal”. Pediatrics 2012. Length of Stay Readmission – 30 day and 1 year

Figure 1 from Patrick SW et al. Hospital Pediatrics 2015 Figure 2 from Patrick SW et al. Hospital Pediatrics 2015 19 20

Long term implications of 30 day readmission risk factors in-utero opiate/opioid exposure

• Multi-factorial (social determinants of health)

• Inconsistent data, but some suggestions of neurodevelopmental implications from the in utero exposure

• Visual impairment (nystagmus) 1

• Hepatitis C follow up (where applicable)

• Impact on school performance2

1McGlone et al. British Journal of Ophthalmol 2014 Table 2 from Patrick SW et al. Hospital Pediatrics 2015 2 21 22 Oei et al. Pediatrics 2017

School Performance

Management of newborns with in- utero exposure to opiates/opioids

Figure 2 from Oei et al. Pediatrics 2017 23 24 Assessment for Supportive Care withdrawal • Non-pharmacologic management • Finnegan Scale • Environmental stressors • Eat, Sleep, Console (ESC) • Social stressors

• Maternal care

• Breastfeeding support

• Rooming in with the mother

25 26

Pharmacologic Keys to Neonatal management Management

• 1st line medication • Multidisciplinary approach –Morphine • Start antenatal when possible –Methadone • Standardize –Buprenorphine • Standardize –Clonidine • Standardize • Adjunct Treatment –Clonidine –Phenobarbital

27 28

Standardization of Care Reduction in and reduced LOS Pharmacologic Treatment • Withdrawal assessment (“scoring”)1 –3 day reduction in LOS • Weaning of medications2 –10 day reduction in LOS –14 day reduction in treatment with opioid • Transition to ESC from Finnegan3 –6.5 day reduction in LOS

1Vermont Oxford Network - Patrick SW et al. Pediatrics 2016 Figure 1B from Wachman et al. Journal of Perinatology 2018 2Ohio Perinatal Quality Collaborative – Hall et al. Pediatrics 2014 3Boston Medical Center – Wachman et al. Journal of Perinatology 2018 29 30 Oregon Resources OR – Neonatal Specific • 2017-2018 Oregon Pregnancy and • R11 – Encourage breastfeeding for Opioids Workgroup Recommendations women with opioid use disorder (including medication assisted –Multidisciplinary group treatment) –14 recommendations • R12 – Closely monitor an infant born to • Primary prevention a mother who used opioids during pregnancy. • Secondary prevention –Manage care with a standardized • System and policy protocol for assessment and recommendations treatment of infants at risk for NAS

Accessed 10-28-2019 Accessed 10-28-2019 https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/SUBSTANCEUSE/OPIOIDS/Documents https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/SUBSTANCEUSE/OPIOIDS/Documents /Oregon-Pregnancy-and-Opioids-Recommendations.pdf /Oregon-Pregnancy-and-Opioids-Recommendations.pdf 31 32

Summary Washington • In utero substance exposure of neonates is a rising problem (incidence and cost)

Legacy Salmon PeaceHealth SW Creek • Short term and long term implications of in • Northwest Neonatal Legacy Randall Children’s utero exposure to opiates/opioids OHSU Improvement Priority Alliance Providence Portland

Kaiser Sunnyside • (NW IPA) Providence St. Vincent Breastfeeding/provision of breastmilk is

• 11 level III+ NICUs in Oregon and St. Charles (Bend) RARELY contraindicated and should be

Salem Hospital Southwest Washington Oregon supported • Neonatologists, Advanced Practitioners, Nurses, Families, Pharmacists, and more! • Standardization of care leads to less • Goal: Improving the quality and safety of PeaceHealth Sacred Heart (Eugene) medical care for all newborn infants and pharmacologic treatment and shorter LOS their families throughout the region Asante Rogue Regional Medical Center (Medford) • Multidisciplinary approach that does not start and end with the birth hospitalization http://www.oregon-pip.org/projects/NWIPA.html 34

Questions? Contactme OHSUPhysicianAdvice&ReferralService •503Ͳ494Ͳ4567 •800Ͳ245Ͳ6478(tollͲfree) AtPacificNWUpdateinWomen’sHealth •Thursday:LunchRoundtableHost

Thank You [email protected] @DDukhovny • Depressed mood most of the day, nearly every day – sad, empty, hopeless • Diminished pleasure in all or almost all activities MINDFULNESS FOR MAJOR • Significant weight loss or gain DEPRESSION DEPRESSIVE • Insomnia or hypersomnia DISORDER • Psychomotor agitation or retardation CATHERINE POLAN ORZECH M.A. LMFT • Fatigue or loss of energy DSM-5 • Feeling worthless • Difficulty concentrating or indecisiveness • Recurrent thoughts of death

DEPRESSION LOOKS LIKE…

Stage 1 = Unhappiness arises • “…Jane would often wake very early in the morning, unable to sleep, with a heavy feeling in her body and thoughts going round and round, impossible to switch off. UNHAPPINESS She’d sometimes get up to make a cup of tea, sitting in Stage 2 = The unhappy mood brings up negative ITSELF IS NOT thinking patterns, feelings and memories for the the kitchen with a blanket around her shoulders, viewing past – this makes us more unhappy. whatever tidbits she could find on her phone, or trying to THE PROBLEM answer emails that had come through during the night. At last, exhausted, she’d go back to bed, only to find that Stage 3 = We try to get rid of the unhappiness in ways that actually keep it going and just make the thoughts carried on, going round and round, but now things worse. a new voice: “this is terrible. You’ll be too tired to think straight today. Why is this happening? Why can’t you ever pull yourself together? What’s wrong with you?”

I really need people around, but I I wish I could just sleep. My life is don’t have the energy to call I AM DEPRESSED falling apart. anyone.

What’s going to happen to me if I keep feeling this I’ve lost something I’ll never find Depressed way? again. Mood

I remember the last time: feeling so dreadful, I had to give up my job. I’m a failure.

Frustration I’m not good enough. Why does this always happen to me? When we criticize ourselves we’re tapping into the body’s SELF-CRITICISM AND STRESS threat-defense system – amygdala gets triggered, we release cortisol and adrenaline, and get ready to fight, PHYSIOLOGY flee or freeze. OF SELF- COMPASSION When the “threat” is to our self-concept – we feel AND SELF- inadequate or weak we end up attacking the problem – Ourselves! CRITICISM (GILBERT, 2009) This threat response causes even more stress and is related to conditions like anxiety and depression.

Touch Taste Thinking

WHAT IS Vision MINDFULNESS? Smell Hearing

• The Head Space App • Teasedale, J., Williams, M., Segal, Z. (2014) • The Mindfulness App The mindful way workbook: an 8-week • The Mindful Self-Compassion Workbook program to free yourself from depression and RESOURCES (Kristin Neff & Chris Germer) emotional distress. New York: Guilford Press. • Courses FOR • Gilbert, P. ( 2009). The compassionate mind: ƒ Mindfulness-Based Stress Reduction (in-person) REFERENCES DEVELOPING OHSU’s March Wellness Center and in the community A new approach to life’s challenges. Oakland, MINDFULNESS ƒ Mindfulness-Based Cognitive Therapy (online) CA: New Harbinger https://www.mindfulnessstudies.com/personal/mbct-online ƒ Mindful Self-Compassion (online) https://centerformsc.org/lomsc Questions? Contactme

OHSUPhysicianAdvice&ReferralService •503Ͳ494Ͳ4567 •800Ͳ245Ͳ6478(tollͲfree) Overview

• DefiningRPL • Causes • Treatmentoptions • Specialconsiderations

Recurrent Pregnancy Loss

Sacha Krieg MD, PhD Assistant Professor OB/GYN Division of Reproductive Endocrinology and Infertility Oregon Health Sciences University

Miscarriage Recurrentpregnancyloss • • Spontaneouspregnancylossiscommon Twoormoreconsecutive,clinical losses • 15%ofallpregnancies • Whataboutbiochemicalpregnancies?? • Increaseswithage • Pregnancyofunknownlocation • atage40,~40% • • Recurrentpregnancyloss(RPL)impacts1Ͳ5%ofallcouples Couldbeectopicaswell • Definedas2ormoreconsecutivelosses(ASRM) • Evaluationinthisinstanceiscontroversial • Withconfirmedfetalpoleorpathologicaldiagnosis • Poorprognosticfactorforfuturelivebirthrate • <20weeksofpregnancy • RecentstudybyKolte etal.suggeststhateval • Riskofsubsequentlosssimilarfor2or3losses • 30%risk maybebeneficial • Evaluationrecommendedafter2losses

Kolte et al. Hum Reprod 29(5):931-937

OvulationtoImplantation CausesofRPL

Genetic 2-5% Infection 9%

Ovarian aging Endometrial Idiopathic 40% Male Autoimmune 20% Environmental

Anatomic 15-20% Endocrine 20% EvaluationofRPL GeneticcausesofRPL

• Comprise2Ͳ5%ofcases • ParentalKaryotypes • MostcommonlyͲͲ balancedor • Antiphospholipid antibodies Robertsonian translocations (13,14,15,21and22). • Endocrine • Inversion,insertionsand • TSH,antiͲthyroidantibodies mosaicism • Glucosetesting,ovarianreserve,PRL • Treatment • HSGorhysteroscopyw/laparoscopy • Expectantmanagement • Fetalkaryotype ifcurrentlyundergoingaloss • PGD • Culturesifstrongsuspicionforendometritis/cervicitis • DonorGametes

Stephenson and Sierra 2006 Human Reprod. 21(4):1076

DiagnosisofUterineanomalies AnatomiccontributionstoRPL

• HSG • Septate uterus • Hysteroscopy • Mostcommonabnormality • Withconcurrentlaparoscopy • Readilytreatablewithresection • MRI • Livebirthrateafterresection~85% • Evaluatecollectingsystemalso • Leiomyomas • 3DUSw/salineinfusion • Morecontroversial sonography • Submucosal andMyomectomy for transmural >5cmhasabenefit • Livebirthrateashighas93% • Othermullerian anomalies • SmallerincreaseinRPL • Cervicalinsufficiency

Jurkovic et al. 1995 Ultrasound Ob&Gyn Dabirashrafi et al. 1995 Am J OB/Gyn Bajekal and Li 2000 Human Reprod updates

Mullerian anomalies Antiphospholipid antibodysyndrome

• Antiphospholipid • Moststudiesaresmallcase series antibodies • Septate uteri • Impacttrophoblastic • 44%lossrate invasion • Arcuate • Diversepopulationof • 25.7%lossrate antibodies • Bicornuate • 36%lossrate Antiphospholipid antibodysyndrome APLAScontinued • Antiphospholipid Ab syndromelinkedtoRPL • bASA andHeparin • CriteriaforAPLAS(1clinicaland1laboratorycriteria: • TherapeuticlowͲmolecularweightheparin • Clinical: • 1ormorethromboticevents • Steroidshavebeenshowntohavenobenefit • 3consecutivelosseswithoutothercauses • RRoffirsttrimestersABͲ0.46withtreatment • 1fetaldemise>10wksgestation • 1pretermbirthduetoseverepree orplacentalinsufficiency(<34wks) • Laboratory(repeated2timesatleast12wksapart) • ACAlevels(IgG orIgM)inmediumͲhighrange • Plasmalevelsoflupusanticoagulant • AntiͲɴ 2glycoproteinantibodiesinmediumͲhighrange(>40) • TreatmentwithbASA andHeparinresultsinpregnancyrate of70Ͳ75%

ACOG practice bulletin No 118

EndocrinecausesofRPL ThyroiddiseaseandRPL

• Hypothyroidism • Untreatedhypothyroidismassoc.w/RPL • AntiͲthyroidantibodytestingmorecontroversial • TreattoaTSH<2.5 • PoorlycontrolledDM • Increaseby30%inpregnancy • Subclinicalhypothyroidismassoc.w/sAB • Hyperprolactinemia • RoleofantiͲthyroidantibodiesislessclear • Luteal phasedefect • Noevidencetosupporttesting • Untreatedhyperthyroidismassoc.w/sAB andinfertility

Marai et al. Am J Reprod Immunol. 2004 51(3):235-40. Kutteh et al. 1999 Fertil Steril 71: 843 Vaquero et al. Am J Reprod Immunol 43:204-208 Hirahara F et al.1998 Fertil Steril.70:246–252. Negro et al. Best prac Endo and Metab 25(6):927-43

ChronicEndometritis CausesofRPL

• Persistentinflammationoftheendometrium—oftenasymptomatic • Testing Genetic 2-5% • EMBwithpathologyforpresenceofplasmacellsandCD138IHC Infection 9% • AdditionofCD138increasessensitivity Ovarian aging 1Ͳ3 • Incidenceof7%to57.8%intheRPLpopulation Endometrial Idiopathic 40% Male Autoimmune 20% • AnincreaseinLBRhasbeennotedaftertreatment Environmental • 7%to56%aftertreatmentwithdoxycycline(p<0.001)1 • 17.5%to78.4%aftertreatmenttargetedtopathogen(p<0.001)2 • Studiesarelimitedinsize Anatomic 15-20% Endocrine 20% • Asofyet,notarecommendedpartofRPLeval byASRMorACOG

1. McQueen et al. F&S 2014 101(4):1026-1030 2. Cicinelli et al. Reprod Sci 2014 21(5):640-647 3. McQueen et al. F&S 2015 104(4):927-931 IdiopathicRPL AneuploidyandRPL

• PossibleEtiologies: • Overtheageof35,chromosomalabnormalitiesarefoundin78%of POC1 • Ovarian • RPLpatientsundergoingmiscarriage • Aftertheageof35:78%oflossesaredenovo aneuploidies • Inlargerstudiesusingallagegroups2,3 • Malefactor • 70%oflosses<6wksareaneuploid • Endometrial • 50%ofloss6Ͳ10wksareaneuploid • Treatment: • Progesterone,bASA maybeofbenefit • Supportivecare • PGTa • Somewhatcontroversial

1. Marquard et al. 2010 F&S 94(4):1473-1477 Oates-Whitehead et al. Cochrane Database Syst Rev. 16(2):2008 2. Hassold et al. 1985 Human Genetics Lathi et al. 2009 F&S in press 3. Ohno et al. 1991 Obstet Gynecol

IVFwithpreimplantationgeneticscreening IsPGTa usefulforIdiopathicRecurrentPregnancyLoss? forRPL

• ComprehensiveChromosomalScreening • AllowsforscreeningofallchromosomesasopposedtoPGSw/FISH • Severalmodalitiesavailable • SNP • RequiresanIVFcycle • aCGH • Testingforallchromosomes • NGS • Hasthepotentialtoaddressacommoncauseofmiscarriage • MoreevidenceissupportingtheuseofPGTa forolderRPLpatients • Thisbenefitappearstobethegreatestinpatientsovertheageof37 • ControversialaslongertimetolivebirthandneedforRCT • Thisbenefitdoesnotquitereachstatisticalsignificanceinmoststudies

Kushnir et al. 2016 F&S

Progesteronesupplementation LutealProgesterone

• ProgesteroneorHCG supplementation • 2recentRCTscomparingvaginalprogesteroneeither3daysafter • HCGassociatedw/OHSS +OPKorimmediatelyafterUSdocumentedovulation • 500IUQOD • Canalsoconsiderclomid • Stephensonetal.F&S2017n=59 • Vaginalpreparationshave30xgreater • Vaginalprogesterone100Ͳ200mgBIDpv,3daysafterLHsurge endometrialconc. • OR2.1forLivebirth • 200Ͳ600mg/day • Micronized,gelandtablets • Ismailetal.JofMaternalͲfetalandneonatalmedicine2017n=700 • Im progesterone • 400mgprogesteronepessariesvsplacebopessaries • 50mg/day • 91.6%vs77.4%LBR(p<0.05) • Oral • Theprogesteronegroupalsohadalowerrateofpretermdelivery • Prometrium • Assoc.w/poorerpregnancyand increasedsAB rates • IVFpts.

Stephenson et al. 2017 F&S Ismail et al. 2017 J of Maternal-Fetal and neonatal medicine Supportivecare Treatmentoutcomes

• RecurrentPregnancyLossassociatedwith: • Withappropriatetreatmenttheprobabilityofasuccessful • Depression pregnancyisashighas90% • Anxiety • Decreasedselfesteem • GriefprocessfollowsanysAB • Increasedmaritaldiscord • Increaseinsexualdysfunction • Antenatalcounselingandpsychologicalsupport increaseslivebirthrates • 20%ofwomensufferfrompostpartumdepressionafter amiscarriage

Stray-Pederson 1984 Serrano 2006 Klock et al. Psychosomatics 38(5):503-507

Probabilityoflivebirthforpatientswith Conclusions unknownetiology

• RecurrentPregnancyLossisatreatablecondition • Beginevaluationforrecurrentpregnancylossafter2consecutive losses • Consideringkaryotypingproductsofconceptionafter1st loss • Withappropriatetreatmentandsupportivecareahighlivebirthrate maybeexpected Live Birth Rate (%) Live Birth

Number of Miscarriages

*average age 34

Brigham et al. 1999 Human Reprod. 14(11):2868-2871

Questions…?

University Fertility Consultants OHSU Physician Consult OHSU & Referral Service 3303 SW Bond Ave CHH (503) 494-4567 503-418-3700 (800) 245-6478 toll-free Disclosures

Fetal Demise and Stillbirth

DATE: November 15, 2019 PRESENTED BY: Karen Gibbins, MD, MSCI

2

Objectives Stillbirth in the U.S. - definitions

• To give a pragmatic outline of the • 6 per 1000 or 1 in 160 deliveries – not changing following: – 25,000 annually – Incidence, risk factors, and causes of – Oregon: 185 in 2017 or stillbirth • 4.2 per 1000 live births • – Initial workup Neonatal death rate: 3.6 per 1000 births • Defined as fetal death at 20 weeks or greater, – Basic bereavement care or a weight of 350 grams or more if GA – The next pregnancy unknown (50th %ile for 20 weeks) • Terminations are excluded 3 4 • Arbitrary cutoff of 20 weeks

Headline goes here Risk Factors (aOR)

• Bullets go here Modifiable Nonmodifiable

• Bullets go here Chronic HTN 1.19 (NS) Previous loss 2.8

• Bullets go here Diabetes 2.5 Previous stillbirth 6.41

• Bullets go here Drug addiction 2.08 AMA 35-39 1.19

• Bullets go here Tobacco 1.57 AMA 40+ 2.41 • Bullets go here Obesity 1.72 Non-Hispanic Black 2.12 race

Multifetal 4.59 Nulliparity 1.49

5 6 Causes of Stillbirth 35 Causes 30 25 • SCRN: 95% of all stillbirths in 5 20 geographic catchment areas 15 10

• Full workup and INCODE 5

0 assignment in 512 stillbirths Fetal Hyperten Umbilical Maternal Obstetric Placental genetic/s Infection sive Other cord medical tructural disorders All 29.3 23.6 13.7 12.9 10.4 9.2 7.8 3.1 Antepartum 14.8 26.1 15.5 10.1 10.8 9.4 8.7 3.8

7 8

Causes Workup

• FGR: risk of stillbirth with EFW • Shotgun versus targeted approach <5th%ile is 2.5% without monitoring • ACOG: autopsy, karyotype, placental examination, CBC, Kleihauer Betke, • Cord events: parvovirus IgG/IgM, RPR/FTA, lupus – nuchal cord at 30% of normal births anticoagulant, anticardiolipin antibodies, – Need e/o obstruction or circulatory TSH, thrombophilia panel, parental compromise karyotype, indirect Coombs, HgbA1c, – exclude other causes toxicology, further genetic testing

9 10

Useful Diagnostic Tests in Stillbirths Total Point Estimate Pertinent Positive 64.6 59.6 Targeted Testing

42.4 38.1 • If FGR: – placental pathology 88.7% – fetal autopsy 79.2% 11.9 11.1 7.8 – antiphospholipids 32.1% 4.7 6.4 1.6 1.60.8 0.20.4 0.20.2 – genetic testing 26.4% (most had known anomalies) • If hypertensive disorders: – Placental pathology 90% – fetal autopsy 50% – antiphospholipids 28%

11 12 Targeted Testing (cont.) Barriers to autopsy

• If suspected fetal anomalies: • Fewer than 50% of stillbirths receive – fetal autopsy 90.3% autopsy – genetic testing 87.1% • Patient and provider misconceptions – placental pathology 41.9% • Cost • Preterm labor/chorio/PPROM • Provider counseling improves uptake – Placental pathology 80.5% – fetal autopsy 44.2% • Partial autopsy: radiographs, external – genetic testing 5.2% examination, limited incision – fetal-maternal hemorrhage 5.2% • MRI on horizon

13 14

Document Delivery and Bereavement

• Visual appearance – any • Mementos, photographs, dysmorphology, maceration, size videos • Describe placenta and umbilical cord – offer to store • Give chronology • Mixed data on PTSD and • This is your gift to future providers holding • Cuddle Cot • Encourage parenting

15 16

Mode of Delivery Postpartum

• D&E: option based on fetal size, • Notify your staff provider expertise • Eliminate the waiting room • IOL: • EPDS? – mifepristone 200mg – misprostol vs oxytocin • Mental health referral – 20% need for additional procedure • Cesarean only in rare circumstances

17 18 The next pregnancy… Pregnancy after loss

• Recurrence risk – depends on the cause • Frequent visits • Preconception visit • Communicate history to staff • Establish mental health care • Confirm mental health care • • Modify the modifiable Language matters – use baby’s name • Minimal intervention: baby aspirin, LMWH for APS – don’t say “at least” • Genetic screening, early anatomy ultrasound • Avoidance of triggers • Antepartum surveillance – doctor and hospital switching is common • Fetal movement monitoring – ask about rooms to avoid – • Timing of delivery check heartbeat first! • Dates and anniversaries

19 20

Delivery after loss Conclusions

• Delivery room trauma/triggers • Uncommon but not rare • Cause matters • MOD can be complicated • Placental pathology and autopsy are • New layers of grief – high risk for important PPD/anxiety • Small gestures make a big difference

21 22

References

• Autry, A. M., Hayes, E. C., Jacobson, G. F., & Kirby, R. S. (2002). A comparison of medical induction and dilation and evacuation for second-trimester abortion. American Journal of Obstetrics and Gynecology, 187(2), 393–397. • Crane, J. M. G., Keough, M., Murphy, P., Burrage, L., & Hutchens, D. (2011). Effects of environmental tobacco smoke on perinatal outcomesߝ: a retrospective cohort study, 865– 871. • Dudley, D. J., Goldenberg, R., Conway, D., & Silver, R. M. (2010). A New System for Determining the Causes of Stillbirth, 116(2), 254–260. • Mills, T., Ricklesford, C., Cooke, A., Heazell, A., Whitworth, M., & Lavender, T. (2014). Parents’ experiences and expectations of care in pregnancy after stillbirth or neonatal death: a metasynthesis. BJOG: An International Journal of Obstetrics & Gynaecology, Thank You 121(8), 943–950. • Page, J. M., Christiansen-Lindquist, L., Thorsten, V., Parker, C. B., Reddy, U. M., Dudley, D. J., … Silver, R. M. (2017). Diagnostic tests for evaluation of stillbirth: Results from the stillbirth collaborative research network. Obstetrics and Gynecology, 129(4), 699–706 • Silver, R., Siassakos, D., & Dudley, D. (2018). Pregnancy after stillbirth: anxiety and a whole lot more. BJOG: An International Journal of Obstetrics & Gynaecology, 125(2), 211– 211. Stillbirth Collaborative Research Network Writing Group (2011). Causes of death among stillbirths. JAMA, 306(22): 2459-2468.

23

Grief

• Grief has physical, emotional, spiritual, and social components

• Non-linear process o States rather than stages of grief

Psychological Aftermaths of • Anger is component of grief Pregnancy Loss

Teni Davoudian, PhD, ABPP Clinical Psychologist Assistant Professor in Psychiatry & Ob/Gyn November 15, 2019

Pregnancy Loss Grief Grief vs. Major Depression

Grief Major Depression • Facilitates bond with deceased as a coping strategy Course x Decreases over time x Persistent depressed mood x Waves of grief (triggered by • “Prospective” grieving for the life and relationship projected thoughts/reminders of the deceased) into the future (versus retrospective grieving) Emotional x Normal to experience positive emotions and x Pervasive unhappiness Spectrum laughter while grieving x Misery • Peaks at 6 months x Fluctuating ability to feel pleasure

Cognitive x Thoughts and memories of deceased x Self-critical thoughts • Women also grieving: Processes x Negative ruminations

o Loss of confidence in one’s body Self-Esteem x Mostly preserved through grief process x Lowered self-esteem x Some concerns about “failing” the deceased x Self-loathing o Loss of confidence in medicine x Worthlessness

o Loss of control Suicidal Ideation x If SI occurs, it is in the context of reuniting x Focused on ending one’s life with the deceased due to feelings of worthlessness and perceived inability to cope with depression

Comorbid Psych Dx Public Perceptions of Miscarriage

• Major Depressive Disorder • Majority believe that miscarriage occurs <5% of pregnancies (Bardos et al., 2015) o RPL: 5x more likely to develop moderate/severe depression (Kolte, 2015) • Believed causes of miscarriage: o 95% genetic abnormalities • Generalized anxiety disorder o 76% stressful event o RPL: Increased severity of generalized anxiety (Fertl et al, 2009) o 64% lifting heavy object o 31% past abortion • PTSD (Englehard, 2004) o 28% previous use of IUD o 21% getting into an argument

• Guilt, self-blame, and isolation (Bardos et al., 2015) • Possible psychological results of misconceptions: • No validated psych screenings specific to pregnancy loss o Feelings of isolation and guilt among women who experience miscarriage(s) Public Perceptions of Miscarriage Pregnancy Loss & Relationships

• Emotional reactions of women with history of • Gap in literature regarding experiences of same-sex couples,

miscarriage(s): (Bardos et al., 2015) transgender individuals, single parents by choice o 47% felt guilty • Discordant/incongruent grief among men and women in o 41% reported that they had done something wrong heterosexual relationships (Serrano & Lima, 2006) o 41% felt alone o 28% felt ashamed • Sexuality following pregnancy loss: (Zhang et al., 2016) o Women: lowered libido o 19% blamed self even when cause of miscarriage found o Men: decreased sexual satisfaction, increased erectile dysfunction

• Higher risk of relationship dissolution for up to 3 years after loss (Gold, Sen, & Hayward, 2010)

Other Stakeholders IUFD & Stillbirth

• Surviving sibling(s) grieve: (Calister, 2006) • Elevated anxiety and depression for 2 years following IUFD (Cacciatore et al., 2008) o Loss of their expected sibling

o Loss of the parents as they knew them prior to the loss • Higher risk of relationship dissolution for up to 9-10 years after IUFD (Gold, Sen, & Hayward, 2010)

• Supporting grieving children: • IUFD has no major impact on women’s QoL or risk of experiencing o Recognize and acknowledge the child’s grief depression 18 years after loss (Gravensteen et al., 2012) o Read children’s books about death (Erlandsson et al., 2010)

o Allow children to witness some of parent’s grief (Erlandsson et al., 2010) • Interventions that may mitigate long-term psychopathology: (Gravensteen et al., 2012) o Postpartum consultation with the obstetrician or midwife o Meeting with a psychologist/psychiatrist o Follow-up from PCP o Consultation with a religious counsellor

Supporting Patients Supporting Patients

• Mimic patient’s vocabulary regarding fetus • Following a loss, patients desire: (Evans, 2012; Koert et al., 2018; Munsters et al., 2011)

o Inclusion of partner in consultations and treatments • Ask open ended questions

• Depending on gestational age, inquire about patient’s intent or o Reliable and accurate information about miscarriages interest in memorializing the fetus

o Attention to both physical and psychological aspects of miscarriage • If appropriate, remind patient that she is not to be blamed

o Access to psychological treatment o Women who receive reassurance from their providers following a loss report less guilt and self-blame (Corbett-Owen & Kruger, 2001) o Practical advice about lifestyle and diet • Avoid comments that may trivialize the patient’s loss o Written information • Who are you trying to comfort? The patient(s) or yourself? Patient Care Factors to Consider Resources Books: • Setting (Covington, 2009) • Conquering Infertility: Dr. Alice Domar's Mind/Body Guide to Enhancing Fertility o Privacy? Patient dressed? and Coping with Infertility By Alice Domar, PhD

• Perception of patient(s) • Not Broken: An Approachable Guide to Miscarriage and Recurrent Pregnancy Loss o Assess her/his/their understanding of the loss By Lora Shahine

• Invite emotional reactions • Loved Baby: 31 Devotions Helping You Grieve and Cherish Your Child after o “Would you like to talk about how you’re feeling right now?” Pregnancy Loss By Sarah Philpott, PhD

• Provide plan for next steps Support Groups: o What happens next? Which medical providers will be there? • Resolve Support Group • Brief Encounters

References References

• Due, C., Chiarolli, S., & Riggs, D. W. (2017). The impact of pregnancy loss on men’s health and wellbeing: a systematic • Abboud, L., & Liamputtong, P. (2005). When pregnancy fails: coping strategies, support networks and review. BMC Pregnancy and Childbirth, 17(1), 380. experiences with health care of ethnic women and their partners. Journal of Reproductive and Infant Psychology, 23(1), 3-18. • Engelhard, I. M. (2004). Miscarriage as a traumatic event. Clinical obstetrics and gynecology, 47(3), 547-551.

• Armstrong, D. (2001). Exploring fathers’ experiences of pregnancy after a prior perinatal loss. MCN: The • American Journal of Maternal/Child Nursing, 26(3), 147-153. Erlandsson, K., Avelin, P., Saflund, K., Wredling, R., & Radestad, I. (2010). Siblings’ farewell to a stillborn sister or brother and parents’ support to their older children: a questionnaire study from the parents’ perspective. Journal of Child Health Care, 14(2), 151-160. • Bardos, J., Hercz, D., Friedenthal, J., Missmer, S. A., & Williams, Z. (2015). A national survey on public perceptions of miscarriage. Obstetrics and gynecology, 125(6), 1313. • Fertl, K. I., Bergner, A., Beyer, R., Klapp, B. F., & Rauchfuss, M. (2009). Levels and effects of different forms of anxiety • Cacciatore, J., Rådestad, I., & Frederik Frøen, J. (2008). Effects of contact with stillborn babies on maternal during pregnancy after a prior miscarriage. European Journal of Obstetrics & Gynecology and Reproductive Biology, anxiety and depression. Birth, 35(4), 313-320. 142(1), 23-29.

• Callister, L. C. (2006). Perinatal loss: A family perspective. Journal of Perinatal and • Gameiro, S., van den Belt-Dusebout, A. W., Bleiker, E., Braat, D., van Leeuwen, F. E., & Verhaak, C. M. (2014). Do children Neonatal Nursing, 20(3), 227-234. make you happier? Sustained child-wish and mental health in women 11–17 years after fertility treatment. Human Reproduction, 29(10), 2238-2246.

• Corbet-Owen, C., & Kruger, L. M. (2001). The health system and emotional care: Validating the many meanings of spontaneous pregnancy loss. Families, Systems, & Health, 19(4), 411. • Gissler, M., Hemminki, E., & Lonnqvist, J. (1996). Suicides after pregnancy in Finland, 1987–94: register linkage study. Bmj, 313(7070), 1431-1434. • Covington, S. N. (2009). Pregnancy Loss: A Protocol to Help Patients COPE. Topics in Obstetrics & Gynecology, 29(9), 1-7. • Gravensteen, I. K., Helgadottir, L. B., Jacobsen, E. M., Sandset, P. M., & Ekeberg, Ø. (2012). Long-term impact of intrauterine fetal death on quality of life and depression: a case–control study. BMC pregnancy and childbirth, 12(1), 43.

References References

• Gold, K. J., Sen, A., & Hayward, R. A. (2010). Marriage and cohabitation outcomes after pregnancy loss. Pediatrics, • Magee, P. L., MacLeod, A. K., Tata, P., & Regan, L. (2003). Psychological distress in recurrent miscarriage: the role of 125(5), e1202-e1207. prospective thinking and role and goal investment. Journal of Reproductive and Infant Psychology, 21(1), 35-47.

• He, L., Wang, T., Xu, H., Chen, C., Liu, Z., Kang, X., & Zhao, A. (2019). Prevalence of depression and anxiety in women • Musters, A. M., Taminiau-Bloem, E. F., van den Boogaard, E., van der Veen, F., & Goddijn, M. (2011). Supportive care with recurrent pregnancy loss and the associated risk factors. Archives of gynecology and obstetrics, 1-6. for women with unexplained recurrent miscarriage: patients’ perspectives. Human reproduction, 26(4), 873-877.

• Kersting, A., Dölemeyer, R., Steinig, J., Walter, F., Kroker, K., Baust, K., & Wagner, B. (2013). Brief internet-based • O'Leary, J. M., & Gaziano, C. (2011). Sibling grief after perinatal loss. Journal of Prenatal & Perinatal Psychology & intervention reduces posttraumatic stress and prolonged grief in parents after the loss of a child during pregnancy: Health, 25(3), 173. a randomized controlled trial. Psychotherapy and Psychosomatics, 82(6), 372-381. • Ockhuijsen, H. D., Boivin, J., van den Hoogen, A., & Macklon, N. S. (2013). Coping after recurrent miscarriage: • Kolte, A. M., Olsen, L. R., Mikkelsen, E. M., Christiansen, O. B., & Nielsen, H. S. (2015). Depression and emotional uncertainty and bracing for the worst. J Fam Plann Reprod Health Care, 39(4), 250-256. stress is highly prevalent among women with recurrent pregnancy loss. Human Reproduction, 30(4), 777-782. • Purandare, N., Ryan, G., Ciprike, V., Trevisan, J., Sheehan, J., & Geary, M. (2012). Grieving after early pregnancy loss- • Koert, E., Malling, G. M. H., Sylvest, R., Krog, M. C., Kolte, A. M., Schmidt, L., & Nielsen, H. S. (2018). Recurrent -a common reality.) Irish Medical Journal, 105. pregnancy loss: couples’ perspectives on their need for treatment, support and follow up. Human Reproduction, 34(2), 291-296. • Saraiya M, Green CA, Berg CJ, Hopkins FW, Koonin LM, Atrash HK (1999) Spontaneous abortion – related deaths among women in the United States – 1981–1991. Obstet Gynecol 94:172–176 • Lok, I. H., & Neugebauer, R. (2007). Psychological morbidity following miscarriage. Best Practice & Research Clinical Obstetrics & Gynaecology, 21(2), 229-247. • Serrano, F., & Lima, M. L. (2006). Recurrent miscarriage: psychological and relational consequences for couples. Psychology and Psychotherapy: Theory, Research and Practice, 79(4), 585-594 • Lok, I. H., Yip, A. S. K., Lee, D. T. S., Sahota, D., & Chung, T. K. H. (2010). A 1-year longitudinal study of psychological morbidity after miscarriage. Fertility and sterility, 93(6), 1966-1975. Questions? References Contactme

• Turton, P., Badenhorst, W., Hughes, P., Ward, J., Riches, S., & White, S. (2006). Psychological impact of stillbirth on OHSUPhysicianAdvice&ReferralService fathers in the subsequent pregnancy and puerperium. The British Journal of Psychiatry, 188(2), 165-172 •503Ͳ494Ͳ4567 • Wilson, R. E. (2001). Parents’ support of their other children after a miscarriage or perinatal death. Early Human Development, 61(1), 55-65. •800Ͳ245Ͳ6478(tollͲfree)

• Zhang, Y. X., Zhang, X. Q., Wang, Q. R., Yuan, Y. Q., Yang, J. G., Zhang, X. W., & Li, Q. (2016). Psychological burden, sexual satisfaction and erectile function in men whose partners experience recurrent pregnancy loss in China: a cross-sectional study. Reproductive health, 13(1), 73.

Thank You Disclosures/Conflict of Interest

• None

Updates in Cervical Cancer Screening and HPV Disease Prevention

Katie Au, MD Assistant Professor Obstetrics & Gynecology

DATE: NOVEMBER 15, 2019

2

Objectives

• Describe the burden of HPV disease

• Review HPV vaccination practices

• Review pap test and cervical cancer screening guidelines

• Future directions Understanding the Burden HPV INFECTION & DISEASE

3

HPV Infection

• Most common STI: The CDC estimates >80% of sexually active men and women • Most females and males will be infected with at least one type of mucosal HPV at some point in their lives – Estimated 79 million Americans currently infected – 14 million new infections/year in the US – HPV infection is most common in people in their teens and early 20s (likely soon after sexual debut) • Most people will never know that they have been infected

1 National Cancer Institute

6 Satterwhite et al. Sex Transm Dis. 2013 Cervical Cancer Is Preventable! Cervical Cancer Cervical Cancer is Preventable!

• Worldwide: ~500,000 new cases each year Prevention Tools

– Leading cause of cancer-related Secondary Primary Prevention death in women in underdeveloped Prevention countries Pap Smear/HPV HPV Vaccination • United States: ~11,000 new cases each Testing year & ~4,000 deaths 1. Detection of pre-invasive – ~110 new cases in Oregon annually disease • >90% association with HPV 2. Detection of early stage cancer – >60% associated with subtype 16 3. Fertility sparing cancer surgery

7

HPV Vaccines Currently Licensed in U.S. Bivalent Quadrivalent 9-Valent Primary HPV Prevention 2vHPV 4vHPV 9vHPV (Cervarix) (Gardasil) (Gardasil 9) GlaxoSmithKlin Manufacturer Merck Merck e 6, 11, 16, 18, HPV Types 16, 18 6, 11, 16, 18 31, 33, 45, 52, Included 58

Contraindicatio Hypersensitivity Hypersensitivity Hypersensitivity ns to latex* to yeast to yeast Ages 15-45 3 dose series: 3 dose series: Dose Schedule 3 dose series: 0, 1, 6 months 0, 2, 6 months 0, 2, 6 months Ages 9-14 UPDATED 2 dose series: Dose Schedule 9 0, 6 months

HPV Vaccine Recommendations

CDC recommends routine vaccination at age 11 or 12 years to prevent HPV cancers, for both boys and girls “But what about

• The vaccination series can be started at age 9 adults years • Two doses of vaccine are recommended ages 27 to 45?” • The second dose of the vaccine should be administered 6 to 12 months after the first dose.

11 12 Meitesetal.MMWR.2016. FDA, October 2018

“In 3,200 women ages 27 through 45, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

14

Number Needed to Vaccinate

Anogenital CIN2 + Cancer Warts Ages 9-26 40 450 3,260

Adults 120 800 6,500 through age 45 y/o

15 16

Should adults ages 27-45 be vaccinated? “Evidence suggests that although HPV • vaccination is safe for adults aged 27 through Vaccination is not recommended for everyone older than age 26 years. 45 years, population benefit would be minimal; • Most sexually active adults have already been nevertheless, some adults who are not exposed to HPV, although not necessarily all of the adequately vaccinated might be at risk for HPV types targeted by vaccination. At any age, new HPV infection and might benefit from having a new sex partner is a risk factor for getting vaccination in this age range.” a new HPV infection. People who are already in a long-term, mutually monogamous relationship are not likely to get a new HPV infection. • HPV vaccination prevents new HPV infections but does not treat existing infections or diseases.

17 18 https://www.cdc.gov/hpv/hcp/schedules-recommendations.html HPV vaccination provides the most benefit when given before a person is exposed to any HPV. That’s why CDC recommends HPV vaccination at ages 11-12.

19 MMWR August 24, 2018

Monitoring Impact of HPV Vaccine Programs on HPV-Associated Outcomes HPV VACCINE IMPACT

Objectives

• Describe the burden of HPV disease

• Review HPV vaccination practices

• Review pap test and cervical cancer screening guidelines

• Future directions

24 Cervical Cancer Is Preventable! Cervical Cancer is Preventable! Pap Smear Screening

Prevention Tools

Secondary Primary Prevention Prevention Pap Smear/HPV HPV Vaccination Testing

1. Detection of pre-invasive disease 2. Detection of early stage cancer 3. Fertility sparing cancer surgery

Rationale for screening Cervical Dysplasia

27 28

August 21, 2018 Screening Guidelines

Grade A Recommendation

Grade A Recommendation 2018 USPSTF Update Ages 30-65 Ages 30-65

• CYTOLOGY ALONE q 3 years, based on • Cytology q3 years observational data and modeling studies • hr-HPV and cytology Co-test q 5 years – Lower sensitivity than primary hrHPV testing or • hr-HPV alone q5 years cotesting – USPSTF update in 2018 ! – Lower false-positive rate and rate of additional testing – Compared to no screening, cytology q3y can reduce the number of cervical cancer deaths from 8.34 to 0.76 deaths per 1000 women

31 32

2018 USPSTF Update 2018 USPSTF Update Ages 30-65 Ages 30-65

• COTESTING q 5 years, based on RCTs, • PRIMARY hrHPV TESTING q 5 years, prospective cohort studies, and modeling studies: based on RCTs, one prospective study, and – May detect slightly more cases of CIN than modeling studies: screening with hrHPV testing alone but with a significant increase in the number of tests and – Has adequate sensitivity procedures – Compared with no screening, primary hrHPV – Highest false-positive rate screening q5y can reduce the number of – Compared to no screening, contesting q 5 years cervical cancer deaths from 8.34 to 0.29 can reduce the number of cervical cancer deaths from 8.34 to 0.30 deaths per 1000 deaths per 1000 women women

33 34

Other Organizations “USPSTF now recommends screening every 5

years with hrHPV testing alone as an alternative • AAFP: in agreement with USPSTF to screening every 3 years with cytology alone • ACS/ASCCP: cotesting q 5 years or cytology q 3 years among women aged 30 to 65 years. These are the • ASCCP/SGO interim update 2015: primary hrHPV 2 preferred screening strategies…. Cotesting as screening starting at age 25 as an alternate to an alternative strategy has demonstrated cytology alone or cotesting similar effectiveness, although it may result in • ACOG: cytology alone and cotesting still specifically more tests and procedures compared with either recommended, but primary hrHPV screening in cytology or hrHPV testing alone.” women 25 and older can be considered as an alternative

35 36 Screening Guidelines Future Directions

• ASCCP Guidelines 2020

Grade A Recommendation • HPV self swabs? • Improving HPV vaccination rates

Grade A Recommendation

38

ASCCP 2020

• Better incorporate a patient’s prior history in addition to current results (“Risk-Based”) • Will use a computer-based risk matrix to estimate/calculate a patient’s risk of CIN3 based on her current and prior results • Focuses more on CIN3 as a pre-cancer and less on CIN2 (which has a higher chance of regression and is a less reproducible result) • Should clarify who needs 1 yr vs 3 yr vs 5 yr follow-up

39 40

Visit www.asccp.org Download the app!

41 42 Questions? Contactme

OHSUPhysicianAdvice&ReferralService •503Ͳ494Ͳ4567 •800Ͳ245Ͳ6478(tollͲfree) AtPacificNWUpdateinWomen’sHealth •Friday:LunchRoundtableHost

Thank You Disclosures

Nothing to disclose

PACIFIC NW UPDATE IN OBGYN AND WOMEN’S HEALTH HPV and Anal Neoplasia

Daniel Herzig, MD, FACS, FASCRS Digestive Health Center and Knight Cancer Institute November 15, 2019

Anatomy

Describe how HPV affects the anus

Review the current trends in anal cancer

and anal dysplasia epidemiology Rectum ATZ

Evaluate current strategies for screening

and prevention Anus

DH1 Anatomy

Anal Canal Anal Margin • Uncommon • Very uncommon • HPV, HIV, immune • Like SCC of the skin •Treatment is •Easily treated with complex WLE Anal canal

Anal margin Anal verge Anal canal cancer Anal canal cancer

8,000 cases per year, 80% HPV related Is there an impending epidemic of anal cancer? HIV, immunosuppression, increasing age, female gender, ARI are risk factors Is anal dysplasia the precursor lesion?

Terminology, staging and treatment Can treatment of anal dysplasia prevent the progression to cancer?

You should be listening to someone else…. We’ll find out later…

Known Knowns: Terminology Known Knowns: staging and treatment

Treatment Low -grade Squamous Intraepithelial Lesion (LSIL) Staging Nigro protocol High-grade Squamous Intraepithelial Lesion (HSIL) T: <2cm, 2-5 cm, >5 cm, adjacent organs radiation (54-59 Gy) N: inguinal/internal iliac, external iliac 5-FU/mitomycin M: Metastases 5FU/cisplatin (2nd choice) Trial:pembrolizumab Most present with early stage tumors Cure rates 70-80% Anal Intraepithelial Neoplasia I (AIN1) Anal Intraepithelial Neoplasia 2/3 (AIN2, AIN3) Squamous cell carcinoma in situ

Darragh et al. Arch Pathol Lab Med. 2012;136:1266–1297. Ajani et al. JAMA. 2008;299:1914–1921..

Known Unknowns: An Epidemic? Known Unknowns: An Epidemic?

CancerResearchUK CancerResearchUK Known Unknowns: An Epidemic?

CDC/National Center for CancerResearchUK Health Statistics

Known Unknowns: An Epidemic? Known Unknowns: Can we prevent anal cancer?

Rate of AIN3/HSIL in HIV pos MSM: 30% Incidence of anal cancer in HIV pos MSM 45/100K Incidence of anal cancer in HIV neg MSM 5.1/100K

CDC/National Center for Health Statistics Machalek et al. Lancet Oncol. 2012;13:487–500.

Known Unknowns: Screening for high risk HRA Technique individuals?

Anal Pap Sensitivity ~60%, HPV testing (p16 staining) Specificity~40%

High resolution anoscopy (HRA) Screening/Treatment

Stewart et al. Dis Colon Rectum 2018; 61: 755–77. Known Unknowns: Role of HRA Ablation options

Topical : TCA, 5 FU, Imiquimod Surgical: HRA or electrocautery Vaccine: no effect

Wilkin et al. Clin Infect Dis. 2018;67:1339-1346 Stewart et al. Dis Colon Rectum 2018; 61: 755–77.

Known Unknowns: Can we prevent anal cancer?

4 studies with HRA-based intensive treatment: Describe how HPV affects the anus ~50% recurrence of HSIL Cancer incidence up to 1% per year 1/377-633 per year HIV pos MSM 1/4000 per year HIV neg MSM Review the current trends in anal cancer and anal dysplasia epidemiology SEER database, 2000-2011 592 patients, HIV pos, AIN3 33 patients developed SCCA 1.2% at 1 yr Evaluate current strategies for screening 5.7% at 5 yrs and prevention Median time 24 months

Machalek et al. Lancet Oncol. 2012;13:487–500. No difference based on treatment (or any) Arens et al. Dis Colon Rectum 2019;62:934-40.

Questions? Contactme

OHSUPhysicianAdvice&ReferralService •503Ͳ494Ͳ4567 •800Ͳ245Ͳ6478(tollͲfree)

Thank You 43rdAnnual Pacific Northwest Update in MenopauseandMidlifeSexuality:abitdry ObǦGyn andWomen’s Heath butamusthaveconversation Keynote Lecture Cheryl B. Iglesia, MD November 15,20191:15Ǧ2:15 Director, Section of Female Pelvic Medicine and Reconstructive Surgery MedStar Washington Hospital Center Professor, ObGyn and Urology Georgetown University School of Medicine

Learning Objectives Yes...EvenYOURMotherhasSex: 60istheNew40

• Define vulvovaginal atrophy (VVA), and genitourinary syndrome (GSM) and the impact on post-menopausal dyspareunia • Identify clinician-based & patient-based factors may inhibit the diagnosis of dyspareunia • Describe clinician counseling approaches to facilitate a discussion about their symptoms • Discuss the benefits and risks of innovative therapeutic interventions indicated for the management of menopause related dyspareunia including hormonal, non-hormonal and energy- based therapies

MichelleObama,55 BrigitteMacron,66 DianeSawyer,73

CorrelatesofSexualActivityinOlderWomen:MIDUSII Postmenopausal women are still sexually active

• 20% NotSexuallyActivemeanage62.0(11.8)n=771 18% 16% • 14% SexuallyActivemeanage51.8(10.9)n=1345 12% 10% 8% 6% 4% 2% • RomanticPartnerStatusbestpredictorofwhetheronewassexuallyactive 0% Less than Every other Once a Twice a Once a 2-3 times 4-5 times Daily I have not (regardlessofage)evenforwomenintheir70sand80s 6 times per month month month week per week per week engaged in year sexual activity with my partner • Sexuallyactivewomenstillsexuallysatisfiedregardlessofageormenopausestatus in over a year Kingsberg, S. Millheiser L. NAMS Poster 2016

Thomas, Hess, Thurston Ann Fam Med 2015, vol 13.

5 TwoMostPrevalentSexualProblemsinPostmenopausalWomen TheImpactofSexualDysfunctiononaRelationship

Whensexisgood Whensexisbad/nonǦexistent

• DyspareuniaDuetoGenitourinarySyndromeofMenopause(GSM) Itplaysaninordinatelypowerful Itadds15Ǧ20%additionalvalue • HypoactiveSexualDesireDisorder(HSDD) roledrainingtherelationshipofall toarelationship positivevalue,about50Ǧ70%!

Barry McCarthy 1997 JSMT

7 8

GenitourinarySyndromeofMenopause(GSM) VulvarandVaginalAtrophy(VVA)

• Acollectionofsymptomsandsignsassociatedwithdecreasedestrogenand •Affectsupto69%ofpostmenopausalwomen1,2 andhasadetrimentaleffectonquality othersexsteroids oflifeandsexualfunction3,4 – Caninvolvechangestolabiamajora/minora,vestibule/introitus,clitoris,vagina,urethra,and bladder – Symptomsinclude,butarenotlimitedto,dryness,painwithsexthatmayleadtosubsequent •MostwomendonotseekmedicaltreatmentfortheirVVAsymptoms3 sexualdysfunction,bladderandurethralsymptoms,frequenturinarytractinfections, burning,itching,andirritationthatarebothersomeordistressing. Ǧ Symptomaticvulvovaginal atrophy(VVA)isonecomponentofGSM

Ǧ TreatmentofsymptomaticVVAmayimproveallcomponentsofGSM 1.CummingGP,etal.MenopauseInt 2007;13:79Ǧ83.2.ParishSJ,etal.Int JWomen’s Health 2013;5:437Ǧ447.3. NappiRE,KokotǦKierepa M.Maturitas 2010;67:233Ǧ238.

Portman D, Gass M et al, Menopause 2014

50% ofpostmenopausalwomen 64million sufferfrom PostMenopausalWomen symptomaticGSM1,2 32millionwomen

1.NorthAmericanMenopauseSociety.Menopause.2013;20(9):888Ǧ902. PortmanDJ,Gass ML.Menopause.2014;21:1063Ǧ1068.;Kingsberg SAetal.JSexMed.2013;10:1790Ǧ1799. 2.WysockiSetal.Clin MedInsightsReprod Health. 2014;8:23Ǧ30 KrychmanM,GrahamS,BernickB,Mirkin S,Kingsberg SA.JSexMed.2017;Kingsberg SA,WysockiS,MagnusL,KrychmanML.JSexMed.2013 25%using OTCMoisturizers AndLubricants4 50% Only50% 50% ofpostmenopausalwomen (16million) ofpostmenopausalwomen sufferfrom ofwomenever sufferfrom symptomaticGSM1,2 seek symptomaticGSM1,2 2,3 32millionwomen treatment 32millionwomen

OTC,overǦtheǦcounter. OTC,overǦtheǦcounter. 1.NorthAmericanMenopauseSociety.Menopause.2013;20(9):888Ǧ902. 1.NorthAmericanMenopauseSociety.Menopause.2013;20(9):888Ǧ902. 2.WysockiSetal.Clin MedInsightsReprod Health. 2014;8:23Ǧ30 2.WysockiSetal.Clin MedInsightsReprod Health. 2014;8:23Ǧ30 3.MacBrideMBetal.MayoClin Proc.2010;85:87Ǧ94. 3.MacBrideMBetal.MayoClin Proc.2010;85:87Ǧ94. 4.TherapeuticsMD “EMPOWER”Survey,2016 4.TherapeuticsMD “EMPOWER”Survey,2016

25%using 25%using OTCMoisturizers OTCMoisturizers AndLubricants4 AndLubricants4 50% 50% Only50% ofpostmenopausalwomen ofpostmenopausalwomen (16million) sufferfrom sufferfrom ofwomenever 1,2 1,2 seek symptomaticGSM 18%pastusersof symptomaticGSM 18%pastusersof treatment3,4 32millionwomen PrescriptionMeds 32millionwomen PrescriptionMeds whodiscontinued4 whodiscontinued4

OTC,overǦtheǦcounter. OTC,overǦtheǦcounter. 1.NorthAmericanMenopauseSociety.Menopause.2013;20(9):888Ǧ902. 1.NorthAmericanMenopauseSociety.Menopause.2013;20(9):888Ǧ902. 7%ofWomen 2.WysockiSetal.Clin MedInsightsReprod Health. 2014;8:23Ǧ30 2.WysockiSetal.Clin MedInsightsReprod Health. 2014;8:23Ǧ30 3.MacBrideMBetal.MayoClin Proc.2010;85:87Ǧ94. 3.MacBrideMBetal.MayoClin Proc.2010;85:87Ǧ94. TreatedwithPrescription 4.TherapeuticsMD “EMPOWER”Survey,2016 4.TherapeuticsMD “EMPOWER”Survey,2016 Medication5 5.IMSHealthPlanClaims(April2008ǦMar2011). 5.IMSHealthPlanClaims(April2008ǦMar2011).

OnsetofVasomotorSymptomsvsVulvovaginalSymptoms

25%using Unmet OTCMoisturizers AndLubricants Need 50% Only50% of ofpostmenopausalwomen (16million) Women sufferfrom ofwomenever 1,2 seek 16million symptomaticGSM 18%pastusersof treatment3,4 (50%) 32millionwomen PrescriptionMeds Nevertreated whodiscontinued4

OTC,overǦtheǦcounter. 1.NorthAmericanMenopauseSociety.Menopause.2013;20(9):888Ǧ902. 7%ofWomen 2.WysockiSetal.Clin MedInsightsReprod Health. 2014;8:23Ǧ30 3.MacBrideMBetal.MayoClin Proc.2010;85:87Ǧ94. TreatedwithPrescription 4.TherapeuticsMD “EMPOWER”Survey,2016 Medication5 U.S.WomenDon’tRealizeVVASymptoms SufferinginSilence AreCausedbyMenopause

• Althoughquitecommonandbothersome,mostwomenfailtogettreatment(~93%)1 dueto:

• Whenwomeninthesurveywereasked,inanunaidedquestion,tonamethecauseof – Embarrassment2 theirVVAsymptoms: – LackofknowledgeaboutVVA1

1 – Only24%ofthewomenattributedtheirsymptomsdirectlytoMenopause – Lackofknowledgeofapprovedtreatmentoptions – Negativeattitudesregardinghormonetherapy3 • Ofthe76%citinganothercausefortheirVVAsymptoms,33%respondedthey“Don’t

Know” • REVIVE,RealWomen’sViewsofTreatmentOptionsforMenopausalVaginalChangesSurveyKingsbergS,et Womenwhodoseektreatmentareoftendissatisfiedwiththesafety,convenience,andefficacyofcurrentapproved al.JSexMed.2013;10:1790Ͳ1799. products.1 REVIVE,RealWomen’sViewsofTreatmentOptionsfor 1. Kingsberg SA et al. J Sex Med. 2013;10:1790- MenopausalVaginalChangesSurveyKingsberg S,etal.JSex 1799. Med.2013;10 2. Nappi et al. Maturitas. 2010;67:233-238. 3. Simon et al. Menopause. 2013;20:1043-1048.

FactorsContributingtoSubǦOptimalSexualHealthOutcomesforWomen KeyBarrierstoPatientTreatment

• Lackofawarenessbypatientsofsymptomsrelatingtomenopause2 • SocialStigmaandConversationAvoidance 2 – Femalepatientsareoftenapprehensivetodiscusssexandsexualhealthwithhealthcareprofessionals • LackofdiscussionregardingsymptomswithHCPs – Healthcareprofessionalsmayforegoinitiatingconversationonsexualhealth • SelfǦmedication withOTClubricants/moisturizersand/orherbalmedications17 • LowAwarenessofSexualHealthConditions • Dissatisfactionwithdeliverysystems (e.g.,messycreams)18 – Midlifewomenareoftenunawareorhavemisconceptionsaboutconditionsthatmayadverselyimpacttheirsexuallife • MisperceptionsaboutorLowAwarenessofAvailableTreatments • UnwillingnesstotakeFDAǦapprovedestrogentherapiesdueto“safetyconcerns”5 – Claimsaboutunproventreatmentsareprevalent,asarenegativeperceptionsabouteffectivetreatments • Discontinuation afterinitiation(typically2Ǧ3months)18 • LimitedClinicianTrainingandTime – MostHCPsreceivelittleformalsexualhealthtraining 5. Wysocki S, Kingsberg S, Krychman M. Clin Med Insights: Reprod Health 2014:8 23-30. 17. Al Baghdadi O, Ewies AAA. Climacteric 2009;12:91-105 • Cost,CoverageandRegulatory/PolicyIssues 18. Portman D, Shulman L, Yeaw J, et al. Menopause 2015;22(11):1197-1203. – Highcosts,limitedinsurancecoverage,and/orregulatoryissuesmaypreventuptakeofeffectivetreatments Kingsberg SA,SchafferJ.Faught B,PinkertonJ.etal.FemaleSexualHealth: BarrierstoOptimalOutcomesandaRoadmapforImprovedPatientǦClinican Communications.JWH2019

21 22

ConsistentFindingsAcrossMultipleLargeSurveysofWomenwithVVA ImpactofGSMSymptomsonSexualFunction(REVIVE)

• Name /Date Country Subjects Method Vaginaldryness(55%);dyspareunia(44%);vaginalirritation(37%)

VVAFocus Groups 2015 USA 38;with VVAsymptoms;49Ͳ74y Focus Group GSM symptoms interfere with . . . VIVA 2010 International/USA 3,520;postmenopausal; 55Ͳ65y Onlinesurvey

CLOSER 2011Ͳ12 Europe /NAmerica 4,100;nomenstruationforш12mo;55Ͳ65y Onlinesurvey

REVIVE 3,046/3768postmenopausal;VVAsymptoms;45Ͳ 2012Ͳ14 USA /Europe 75y Onlinesurvey

EMPOWER 2016 USA 1,858;withVVAsymptoms;ш45y Onlinesurvey

CLOSER:ClarifyingVaginalAtrophy’sImpactonSexandRelationship;EMPOWER:Women’sEMPOWERsurvey;REVEAL:RevealingVaginalEffectsatMidǦLife;REVIVE:Real Women’sViewsofTreatmentOptionsforMenopausalVaginalChanges;USA:UnitedStatesofAmerica;VIVA:VaginalHealth:Insight, Views,&Attitudes;PresentedattheNorth AmericanMenopauseSocietyAnnualMeeting,October9,2015,LasVegasNV.

2.Krychman M,GrahamS,Bernick B,Mirkin S,Kingsberg SA.JSexMed.2017

REVIVE,RealWomen’sViewsofTreatmentOptionsforMenopausalVaginalChangesSurvey. 23 KingsbergS,etal.JSexMed.2013;10:1790Ǧ1799. VVAUnmetNeed(REVIVE) The Women’s EMPOWER survey

• Womenreportedonly19%ofHCPsaddressedtheirsexuallife

• Only13%raisedtheissueofVVAsymptomsspecificallyduringtheircheckup Evaluatedpostmenopausalwomen’s: – 50%ofpatientsthinkGSMisanatural—andperhapsunavoidable—consequenceofaging

– OthersdonotassociateGSMwithmenopause – Knowledgeofcondition,causation,andtreatmentoptionsforVVA

– 40%ofthesewomenexpectedthattheirHCPwouldinitiatediscussionrelatedtomenopausalsymptoms – Motivationforseekingandcontinuingtreatment

– InteractionwithHCPs

– Perceptionofexistingproducts

Kingsberg S, Wysocki S, Magnus L, Krychman M. J Sex Med, 2013. Kingsberg S, et al J Sex Med 2017 March 14(3)

TheWomen’sEMPOWERsurvey:TheMostCommonReasonsWhyWomenDoNot BringupPainwithSex BarrierstoCommunication,Diagnosisand TreatmentandSomeSolutions

•Thoughtthesymptomsareapartofaging

• Wereuncomfortable

• Werenotawareoftreatmentsavailable Kingsberg S, et al J Sex Med 2017 March 14 (3)

PhysicianBarrierstoAddressingSexualHealth HCPsAreReluctanttoInitiateDialogueWithTheir PatientsregardingSymptomsofVaginalAtrophy2*

• Perceptionittakestoolong • Considerotherissuesashigherpriorities • HCPembarrassment • Inadequateknowledge/skills • Fearofembarrassingpatient • Assumereimbursementispoor

• FewFDAapprovedtreatments • DataforindividualstudiescanbefoundinspecificreferencescitedinKrychman;**NR=notreported CLOSER:ClarifyingVaginalAtrophy’sImpactonSexandRelationship;EMPOWER:Women’sEMPOWERsurvey;REVEAL:RevealingVaginalEffectsatMidǦLife;REVIVE:Real Women’sViewsofTreatmentOptionsforMenopausalVaginalChanges;USA:UnitedStatesofAmerica;VIVA:VaginalHealth:Insight, Views,&Attitudes;WVM:Women’sVoicesin Menopause

2.Krychman M,GrahamS,Bernick B,Mirkin S,Kingsberg SA.JSexMed.2017InPress.

• Korenman,SG,1998;Brokeman,CPMetal,1994;Eid JFetal,2001;Baum,Netal,1998 30 ScreeningforVVAandDysparuenia OpenǦEndedQuestions

• HCPsaskε1question/min;>90%areclosedǦended • Normalize/universalizeconversationsaboutsexualhealthissues • Actualtimeforpatienttotelltheirstory • StartwithopenǦendedubiquityǦstylequestion Max150seconds,most<60seconds

– “Manywomenaftermenopausestarttodevelopsexualproblemssuchaspainwithsexand/ordryness.What changeshaveyounoticed? OpenǦendedquestionsimprove:

– Open,nonǦdefensivebodyposture • assessmentoffunctionalimpairment

– Sitandmaintaineyecontact • adherence

– Avoidnervousgestures • patientsatisfaction

Sadovsky et al. J Sex Med. 2006;3:795-803. Beckman & Frankel 1984; Marvel et al 1999; Rabinowitz et al, 2004.

DiscomfortwithSilence AllowPatientstoTalk

Researchshowsthat,on Onaverage,howquicklyisa patientinterrupted? averagepatientsare interruptedbyphysicians every12Ͳ23seconds duringaconsultation

- Beckman & Frankel 1984 - Rhoades et al 2001 - Marvel et al 1999 - Langewitz 2002

BasicScreeningforSexualFunction ThePowerofSilence

Legitimizeimportanceofassessingsexualfunction; normalizeaspartofusualhistoryandphysical

Areyoucurrentlyinvolvedina relationship…sexual?

YES NO

Haveyourpartnersincludedmen, Doyouhavesexualconcernsthatyou womenorboth? wouldliketodiscussorthathave Whatsexualconcernsdoyouhave? contributedtolackofsexualbehavior?

Adapted from Kingsberg S. Sex, Urol Clin N Am. 2000;34:497-506. OfficeBasedCounselingforSexualProblems:Follow FIRSTSUMMARY PLISSITModel Permissiontotalkaboutsexualissues,reassuranceandempathy

LimitedInformation e.g.,educationaboutgenitalanatomyoreducationalresources • GSManddyspareuniaiscommonbutunderdiagnosedandundertreated

SpecificSuggestions • InitiatethediscussionwithALLofyourpatients e.g.,useoflubricants,alteringposition • Manysafeandeffectivetreatments

IntensiveTherapy e.g.,referralforpsychotherapy/sextherapy Annon, 1976

BeyondSandpaperSex…orDieTrying GSM Symptoms

• Irritation • Burning • Itching • Increaseddischargeorodor • Dyspareunia • Vaginalandvulvardryness • LUTS—dysuria,frequency,urgency

Bachmann G, et al. Up to Date. 2012; Grady D. N Engl J Med. 2006; Kingsberg S, et al. Int J Women’s Health. 2009; Portman DJ et al JSM 2014

GynecologicalCancersandBreastCancer

• Vaginalatrophyisoftenresultofradiotherapy, chemotherapyand/orhormonalmanipulation Vaginal Consequences • MajorityoftumorsarehormoneǦsensitive of Estrogen Deficiency

Limiteddataonvaginalestrogensinwomenwith hormoneǦsensitivecancers NonǦhormonaltherapiespreferredbutoften ineffective VaginalHistology VaginalMaturationIndex

Postmenopausalvaginalepithelium: – Superficialcellsdecreased – Parabasalcellsincreased

Premenopause Postmenopause

Premenopause Postmenopause Superficialcells 15% 1% Intermediatecells 80% 60% EpitheliumwellǦestrogenized,multiǦ EstrogenǦdeficiencyatrophywith layeredwithgoodbloodsupply, markedthinningofepithelium, Parabasalcells 5% 39% superficialcellsrichinglycogen bloodsupplyreduced,andlossof glycogen FreedmanM.MenopauseManag.2008;17:9Ǧ13.Reprintedwithpermission.

Mechanism of Vulvovaginal Atrophy patientDSG2P2

• Age53pH4Ǧ4.5 E2=51 • Age55 pH5Ǧ5.5 E2=17 • Age56 pH5.5 amenorrheic 2yr

Overgrowthofotherbacteria Lactobacillilevelsdecrease

MacBride M, et al. Mayo Clin Proc. 2010; Krychman ML. Medscape Ob/Gyn. 2007. CourtesyDr.MAFreedman

10/16/2006|pH4.0Ǧ4.5 1/17/2008|pH5.0Ǧ5.5 1/27/2010 3/15/2011

1/22/2009|pH5.5 1/27/2010|pH5.5 3/22/2012 4/4/2013

(CourtesyMFreedman) FDAApprovedOptions FDAǦApprovedTreatmentOptions

Dyspareunia/VulvovaginalAtrophy IMVEXXY™7 VAGIFEM®4 PREMARIN®VAGINAL 8 6 1 INTRAROSA® CREAM

OSPHENA®5 • 2 Localestrogen: ESTRACE® ESTRING®3

–vaginalcream,vaginalring,vaginalpill 1940s 1980–1984 1985–1989 1990–1994 1995–1999 2000–2004 2005–2009 2010–2014 2015–2019 2020

• Ospemifene Estradiol2 Estradiol3 Ospemifene5 (VVA) (VVA) (Dyspareunia) Prasterone6 (Dyspareunia) • DHEAprasterone Solubilized Conjugatedestrogens1 Estradiol7 (Atrophicvaginitis,Dyspareunia) (Dyspareunia) Estradiolhemihydrate4 • Solubized estradiol (Atrophicvaginitis)

1.Premarin(conjugatedestrogens)prescribinginformation,Pfizer. 2.Estrace (estradiol)prescribinginformation,Allergan. 3.Estring (estradiol)prescribinginformation,Pfizer. PREMARIN,ESTRACE,ESTRING,VAGIFEM,OSPHENAandINTRAROSAareregistered 4.Vagifem (estradiol)prescribinginformation,NovoNordiskInc. trademarksoftheirrespectiveowners.IMVEXXYisatrademarkofTherapeuticsMD,Inc. 5.Osphena (opemifene)prescribinginformation,Duchesnay USA,Inc.. 6.Intrarosa (prasterone)prescribinginformation, AMAGPharmaceuticals,Inc. VVA:vulvarandvaginalatrophy 7.IMVEXXY(estradiol)prescribinginformation, TherapeuticsMD,Inc.

Conveying Risks and Warnings About Vaginal NAMSGuidelines2018 Estrogen Therapy 85% Awareandconcernedabout safetyissueswithhormones Low-dose vaginal estrogen therapy is safer than systemic therapy

Santoro N, et al. J Sex Med. 2009.; Grady D. N Engl J Med. 2006.; Bachmann G, et al. Up to Date. 2012.

NAMSGuidelines NAMSGuidelinesfor Individualizetreatmentbasedonsymptoms, BreastCancerSurvivors QoLandriskforrecurrence ER+breastcancerontamoxifen – Withseveresymptoms,localhormoneatlowriskforrecurrence FirstLineTherapy ER+breastcanceronAI – Moisturizers,lubricants,PelvicfloorPT,dilators – Severesymptoms,mayconsiderlocalhormonesorswitchtotamoxifen – LocalhormonesifOKwithoncologist – Compoundedvaginalestriolandtestosteronenotrecommended Triplenegativebreastcancer – Ospemifenenotstudiedinwomenathiriskforbreastcancer – Localhormonereasonablebutdatalacking Womenwithmetastaticdisease Womenathighriskforbreastcancer(BRCAetc) – QoL,intimacy,comfortmaybepriority – LocalhormonesreasonableforthosewhohavefailednonǦhormonetreatment – Useoflocalhormonemaybevieweddifferentlyinwomenwithlimited – Observationaldatasuggestnoincreasedriskofbreastcancer survival

54 Treatment ProductName InitialDose MaintenanceDose OspemifeneandDyspareunia

Vaginalcream AssociatedwithGSM Estrace 17BetaEstradiol 0.5Ǧ1gm/dx2wk 0.5Ǧ1gm1Ǧ3x/wk Premarin ConjugatedEstrogen • Multicenterphase3randomized,doubleǦblind 12Ǧweekefficacyandsafetystudy VaginalInserts Vagifem/Yuvafem 10ug/dx2wk 1twice/wk • 605women40Ǧ80yrs (meanage58)withselfǦreportedmostbothersome Estradiol symptomMBSofdyspareunia Imvexxy 4,10or25ug/dx2wk 1twice/wk 17Betaestradiolsoftgel – Ospemifene60mgpo daily(n=303)vsplacebo(n=303) Intrarosa 6.5mg/d 1/d DHEASprasterone • CoǦprimaryendpoints VaginalRing Estring 7.5ug/day 90days – pH,parabasal,superficialcells

SERM – ChangeinseverityusingVVAsymptomquestionnaireofMBSofdyspareunia Osphena 60mg/d 60mg/d Ospemifene Portman DJ, Bachman GA, Simon JA. Menopause 2013;20(6):1-8.

OspemifeneandDyspareunia OspemifeneandDyspareunia AssociatedwithVVA AssociatedwithVVA Change in baseline to week 12 Change in baseline to week 12

pH MBS Dyspareunia Superficial Cells Parabasal Cells P< 0.0001 versus placebo for all

P< 0.0001 versus placebo for all

Portman DJ, Bachman GA, Simon JA. Menopause 2013;20(6):1-8. Portman DJ, Bachman GA, Simon JA. Menopause 2013;20(6):1-8.

INTRAROSA(prasterone)VaginalInserts: Prasterone Efficacy:2ClinicalStudies PutativeMechanismofAction

Archer etal.1 Labrie etal.2 • ThemechanismofactionofINTRAROSAinpostmenopausalwomenwithvulvarandvaginal atrophyisnotfullyestablished1 #Patients 253 558 Age (mean,range),years 58.6(40Ǧ75) 59.5(40Ǧ80) • Prasterone isasyntheticformoftheinactiveendogenoussteroid,DHEA Study Length 12weeks 12weeks • Prasterone isconvertedinthebodyintoactiveandrogensand/orestrogensby Randomization 1:1:1 2:1 steroidogenicenzymessuchashydroxysteroid dehydrogenases,5ȽǦreductasesand (0.25% prasterone:0.5%prasterone: (0.5%prasterone:placebo) aromatases2 placebo) IntentǦtoǦtreat Allwomenreceivingatleastonedose ofthestudydrugorplacebo CoǦprimaryendpoints %Parabasalcells (changefrombaselineto12weeks) %Superficialcells VaginalpH Changeindyspareuniascore

1INTRAROSA® PrescribingInformation,AMAGPharmaceuticals,February2018. 1 Archeretal.Menopause2015;22:950Ǧ963. 2Labrieetal.Menopause2016;23:243Ǧ256. 2 Labrieetal.Menopause2016;23:243Ǧ256. SignificantDecreasesinDyspareunia SignificantIncreasesin%SuperficialCells withPrasterone VaginalInserts withPrasterone VaginalInserts

Differencefromplacebo:Prasterone(Week12 mean– Baselinemean)–Placebo(Week12 mean– Baselinemean).pǦvaluecalculation analysisofcovarianceusingtreatmentasthe mainfactorandbaselinevalueasthecoǦvariate

Differencefromplacebo:Prasterone (Week12mean– Baselinemean)–Placebo(Week12mean– Baselinemean).pǦvalue calculation:analysisofcovarianceusingtreatmentasthemainfactorandbaselinevalueasthecoǦvariate 1 Archeretal.Menopause2015;22:950Ǧ963. 1 Archeretal.Menopause2015;22:950Ǧ963. 2 Labrie etal.Menopause2016;23:243Ǧ256. 2 Labrie etal.Menopause2016;23:243Ǧ256.

SignificantDecreases in%ParabasalCellswith SignificantDecreasesinVaginalpHwith Prasterone VaginalInserts Prasterone VaginalInserts

Differencefromplacebo:Prasterone(Week 12mean–Baselinemean)–Placebo(Week 12mean–Baselinemean).pǦvalue calculationanalysisofcovarianceusing treatmentasthemainfactorandbaseline valueasthecoǦvariate.

1 Archeretal.Menopause2015;22:950Ǧ963. 2 Labrie etal.Menopause2016;23:243Ǧ256. 1 Archeretal.Menopause2015;22:950Ǧ963. 2 Labrie etal.Menopause2016;23:243Ǧ256.

AdverseReactions Vaginalmoisturizers:Research • 4placeboǦcontrolled,12Ǧweekclinicaltrials(n=1,129),vaginal dischargewasthemostfrequentlyreportedadversereaction(5.71% • Replenshasbeneficialclinicaleffects prasteroneversus3.66%intheplacebogroup)1 – Symptomaticimprovement • Ina52ǦweeknonǦcomparativeclinicaltrial(n=521),vaginaldischarge – Clinicalimprovement wasreportedin14.2%ofwomenandabnormalPapsmearin2.1% • Dryness,pallor,mucosalthinning,petechiae andlabialatrophy – 11casesofabnormalPapsmearat52weeksincluded1caseof • Vaginalcytology lowǦgradesquamousintraepitheliallesion(LSIL)and10casesof – TreatmentwithReplensincreasedmeancellulararea,nochangein atypicalcellsofundeterminedsignificance(ASCUS) maturationindex • 5HPVnegative;4statusunknown;1HPVpositive2 – ReplenslowersvaginalpHduetoacidityandbufferingcapacity – MeanvaginalpH:5.8Ǧ5.2to4.8Ǧ4.7(12weeksoftherapy)

1INTRAROSA® PrescribingInformation,AMAGPharmaceuticals,February2018. Bachmann GA. Clin Pract Sex 1991;7:1-8. 2 Fertil Steril 1994;61:178-80. DataonFile.ERCǦ230ClinicalStudyReport.AMAGPharmaceuticals2017. ProvidedasacourtesybyAMAGPharmaceuticals,Inc.PleaseseefullPrescribingInformation. HybridMoisturizer/Lubricant VulvarSoothingCreams—NoData

Neogyn vulvarsoothingcream® (cutaneouslysate) • LUVENA • >100cytokines • Growthfactors • Prebiotics • InterferonsandantiǦinflammatoryinterleukins:ILǦ1RA, ILǦ4,andILǦ10 • LactoǦperoxidaseandlactoferrin *Inclinicalstudies:improvement(vsplacebo)insymptomsofvulvarpainand dyspareuniainvulvarpainpatients • PurportedlyInhibitscandidaandbacteria Vajuvenate • Avocadobutter,coconutoil,sunfloweroil • Worksasbothamoisturizerandalubricant Releveum with4%lidocaine(DesertHarvest)

Costantino D and Guaraldi C. Minerva Ginecol 2008;60(2):121-5. Donders G. J Lower Genital Tract Dis 2012;16:

Vaginal Atrophy Treatment: Non-hormonal Therapy Non-hormonal Therapy: Lubricants

– Local solutions that temporarily moisturize the vaginal epithelium

– Must be applied at time of intercourse

Marshall DD, et al. OBG Management. 2009; Bachmann G, et al. Up to Date. 2012; Marshall DD, et al. OBG Management. 2009; Bachmann G, et al. Up to Date. 2012. www.amazon.com; www.drugstore.com.

Avoid: Oil- and Petroleum-based Lubricants, Non-hormonal Therapy: Moisturizers Warming Gels, Menthols – Gels or creams used regularly to maintain hydration of the vaginal epithelium for long- term relief of vaginal dryness – Effects last two to three days

Marshall DD, et al. OBG Management. 2009; Bachmann G, et al. Up to Date. 2012; Marshall DD, et al. OBG Management. 2009. Lee YK, et al. Obstet Gynecol. 2011; www.amazon.com; www.drugstore.com. ObGManagementApril2017

AvailableMoisturizers Not Effective, Not Recommended Therapies for Vaginal Atrophy Product Ingredients Use Price Studies

Polycarbophil Replens Every3days $17.5/14app Yes glycerin,mineraloil • Cookingoils Lactoperoxidase LUVENA 2×/wk $20/5app Yes • Oralphytoestrogens lactoferrin

Dimethicone,gelatin,glycerin, • Blackcohosh KYLiquibeads(ovules) 1Ǧ7d/wk No dimethiconol • VaginalvitaminE Variouspolymers KYlonglasting 2Ǧ3×/wk $16/6app No glycerin,mineraloil • OmegaͲ3supplements

Emeritapersonal Aloeveragel,calendula,vitaminE, Asneeded $16/4oz No moisturizer ginseng,chamomile,allantoin

Carbomer,aloe Asneeded Moistagain $7/4oz No glycerin,chlorhexidine

Hyalofemme Hyaluronicacid 7days>2/wk $17/30gram HAǦyes Hydroxyethylcellulose,pluronic, Hill DA, et al. Am Fam Physician. 2010; Bachmann G, et al. Up to Date. 2012; Marshall PreǦseed Asneeded $20/9app Yes arabinogalactan DD, et al. OBG Management. 2009.

Bioidentical Hormones HistologicChangesFractionalCO2

No data to support they are safer than synthetic hormones

ACOG Committee on Gynecologic Practice. Obstet Gynecol. 2005; reaffirmed 2016. FractionatedCO2

Ablative,NonǦablative,Fractional

FractionalPhotothermolysis:Mucosa FDAClearance?

Incision,excision,ablation,vaporizationand coagulationofbodysofttissuesinmedical specialties,includingaesthetic(dermatology& plasticsurgery),podiatry,otolaryngology(ENT), gynecology,neurosurgery,orthopedics,genealand thoracicsurgery(includingopenandendoscopic), dentalandoralsurgeryandgenitourinarysurgery. FDANotifications30July2018 VenusConcept:vaginal healthrestoration Cynosure:painfulsymptomsofmenopauseandintimacy, penetratevaginalwallandstimulatescells Alma:toimprovevaginalirregularities,vaginalmucosa revitalization ScitonDiVa:laservaginaltherapy SGS 2018 Systematic Thermiva:vaginalrejuvenation InMode:Vaginalrejuvenationandurinarystressincontinence Review Group SRG

FractionalCO2Laser ErbiumLaservsEstrogen

Methodological Other Outcome No.Studies TotalN EvidenceQuality Effect OutcomeImportance Quality Considerations Methodological Other Outcome No.Studies TotalN EvidenceQuality Effect OutcomeImportance Quality Considerations VaginalMaturationIndices 1221A(0) 0 Moderate Equal Moderate

Vaginalhealthindex 6 319 1A,5C(0) 0 Low Favors laser Moderate Dryness 2 112 1B,1C(Ǧ1) Ǧ2 Low Equal Critical

Dryness 73111A,6C(Ǧ1) 0 Low Improved Critical Dyspareunia 2 112 1B,1C(Ǧ1) Ǧ2 Low Equal Critical

Burning 52001A,4C(Ǧ1) 0 Low Improved High Irritation 1 50 1B(Ǧ1) Ǧ1LowFavorslaser High

Dyspareunia 93691A,8C(Ǧ1) 0 Low Improved Critical Vaginalhealthindex 1 62 1B(0) 0 Moderate Favorslaser Moderate

Dysuria 31273C(Ǧ1) Ǧ1 Low Improved Moderate Maturationvalue 1 50 1C(0) Ǧ1 Moderate Favorslaser Moderate

VaginalpH 1 50 1C(0) Ǧ1 Moderate Favorslaser Moderate ICIQǦ SF 11611C(0) 0 Low Improved High

FSFI 3 128 1A,2C(0) Ǧ1 Low Equal High ICIQǦSF 1 19 1B(0) 0 Moderate Improved High

Painduringinsertion 2762C(Ǧ1) 0 Low Minimal Moderate

BalanceofBenefitsandHarms

Erbiumlaserisnotsuperiortolocalestrogenfor vaginaldrynessanddyspareunia

Thereareminimalcomparativedatafor fractionalCO2laser TheVaginalLaserversus 6MonthOutcomeDataN=62 VaginalEstrogenTherapy: Conjugated estrogen Fractionated C02 laser Outcome cream P value TheVeLVET Trial N=33 N=29

1 1 2 3 4 5 6 MFRParaiso ,CAFerrando ,MKarram ,ERSokol ,CRRardin ,CAMatthews ,CBIglesia Mean difference VAS score Dryness -5.48 ± 2.68 -5.76 ± 2.48 0.67 Itching -1.84 ± 3.01 -1.24 ± 2.96 0.45 SectionsofUrogynecologyandReconstructivePelvicSurgery Irritation -3.29 ± 3.73 -3.49 ± 3.19 0.87 1ClevelandClinicCleveland,OH;2ChristHospital,Cincinnati,OH;3StanfordUniversityHospital,PaloAlto,CA; Dysuria -1.4 ± 2.89 -2.11 ± 2.85 0.36 4WomenandInfantsHospital,Providence,RI;5WakeForest,WinstonǦSalem,NC;6MedstarWashingtonHospital Center,WashingtonDC Mean difference VHI 0.9 ± 0.7 1.2 ± 0.9 0.07 Mean difference DIVA -3.3 ± 3.2 -4.4 ± 3.1 0.18 Mean difference VMI^ 3.9 ± 30.6 25 ± 22.6 0.04* Mean difference FSFI 1.7 ± 6.7 4.9 ± 8.3 0.1 Mean difference UDI -9.4 ± 15.7 -6.2 ± 12 0.37 % sexually active 45.5 (15) 48.3 (14) 0.82

*statistically significant at P ” 0.05 ^remained statistically significant after controlling for confounding factors

6MonthFSFIOutcomeDataN=62 Results:AdverseEvents

Fractionated Conjugated p C02 laser estrogen cream value N=33 N=29 Mean difference FSFI Score1 Desire† 0.32±1.3 1.02±1.4 0.05*

Mean difference FSFI Score2 Arousal† 0.62±1.6 1.63±1.9 0.03* • Mean difference FSFI Score3 Lubrication 0.11±1.2 0.35±1.4 0.50 10adverseevents(AE)mildormoderate:vaginalbleeding, pain,breasttenderness,UTI,migraine,andabdominal Mean difference FSFI Score4 Orgasm 0.37±1.3 0.9±1.6 0.17 cramping

Mean difference FSFI Score5 Satisfaction 0.88±2.1 1.7±1.7 0.50 • AEsdidnotdifferbetweengroups Mean difference FSFI Score6 Pain -0.59±2.8 -0.04±3.3 0.81

*statistically significant at P ” 0.05 ^remained statistically significant after controlling for confounding factors †no longer statistically significant after controlling for confounding factors VELVETTRIALConclusion FINALSUMMARY 1.FirstlineGSM Moisturizers,lubricants • At6Ǧmonths,fractionatedC02vaginallaserandvaginal PelvicPT,dilators estrogentreatmentresultedinsimilarimprovementinGSM 2.VaginalExerciseǦ–withorwithoutapartner symptomsbutlowerFSFIarousalanddesirescoresinthe 3.LocalhormonetherapyforthosewhofailednonǦhormonaltx laserarm 4.Ospemifeneoraltablet • Similarpatientsatisfactioninbothgroups 5.DHEAS • Noseriousadverseevents 6.Involvetreatingoncologistforbreastcancerpts 7.CompoundedoffǦlabeltestosterone/estriolnotrecommended

AllianceforAdvancingWomen’sHealth FINALSUMMARY(continued) www.advancingwomenshealth.org

8.AdvertisingEnergyBasedTherapy(EBT)forspecific gynecologicconditionsisPREMATURE 9.EarlydatasuggestsbenefitforGSMbutdoneedtodiscuss alternatives 10.Largescalecomparativeandshamtrialsneeded

“Attentionisthemostbasicformoflove.” ZenteacherJohnTarrant

Thankyouforyourattention!

[email protected]

@cheryliglesia

@cbiglesia

102 Objectives

• Identify indications for seeking (in)fertility treatment

• Outline factors contributing to (in)fertility and their evaluation

• Initial Evaluation and Interpret AMH results • Contrast (in)fertility treatments by Treatment of Infertility diagnosis In a Primary Care Setting

DATE: November 15, 2019 PRESENTED BY: Jamie Peregrine, MD, MS Asst Professor, Reproductive Endocrinology and Infertility 2

Other reasons for (in)fertility Infertility evaluation/treatment • Medical history/physical findings that justify • A disease defined by the failure to achieve a – Anovulation/oligoovulation/amenorrhea successful pregnancy after 12 months of – History/anticipated gonadotoxic exposure appropriate, timed unprotected intercourse or • 6 months in women over 35 therapeutic donor insemination • Women over 40 • Need/desire for third-party reproduction – Donor egg/sperm/embryo – Gestational carrier • Recurrent pregnancy loss

3 4 ACOG Committee Opinion Number 781. Infertility Workup for the Women’s Health Specialist. 2019. • Planned fertility preservation

Factors contributory to (in)fertility EVALUATION

• Male factor • Male factor • Semen analysis • Tubal factor • Tubal factor • Hysterosalpingogram • Uterine factor • Uterine factor • Ultrasound/Exam • Ovulation • Ovulation • History/Labs • Ovarian reserve • Ovarian reserve • Ultrasound/Labs

5 6 ACOG Committee Opinion Number 781. Infertility Workup for the Women’s Health Specialist. 2019. Histories Physical Exam • Infertility duration/treatment • OB/GYN • Vitals – Menstrual – Pregnancy • Thyroid – Contraceptive • Breast – Coital/sexual – STI • Signs of androgen excess – Cervical • Surgical/Medical/Medication • Pelvic • Targeted ROS • Family • Exposure 7 8

Semen Analysis Hysterosalpingogram

*Reference ranges vary by lab • Timing: not bleeding, pre- ovulatory WHO 2010, Kruger strict criteria • Doxy 100 mg bid x 5 days if • Volume 1.5 mL history of PID or hydrosalpinx

• Concentration 15 mil/mL

• Motility 40%

• Morphology 4%

9 10

Ovulation Oligo/An- Ovarian reserve

• Midluteal • TSH • AMH >1 ng/mL progesterone > 3 ng/ml • Prolactin • FSH <10 IU/L, E2 < 60-80 pg/ml • Urinary LH • Androgens • AFC >5-7 • Cervical mucus • Gonadotropins • Prior IVF #eggs retrieved >3 • BBT

• Cycle length/ regularity/ molimina/ Mittelschmirtz 11 12 AMH as ovarian reserve marker

• Best single test – with limitations

DOES… DOES NOT… Modify anticipated Predict natural age of menopause fertility/fecundability 1. Routine diagnostic 6. Karyotype screen Correlate with IVF Reliably predict oocyte yield/ oocyte quality/ laparoscopy 7. Prescribing response to chromosome # gonadotropins 2. Advanced sperm testosterone to men Vary by assay, birth Show as much control method intracycle variance function tests 8. FSH to ID menopause as FSH, AFC Broer et al. Clinical implications of Help set Mean someone anti-Mullerian hormone testing. 3. Postcoital test 9. EMB for infertility expectations shouldn’t seek Hum Reprod Update 2014. treatment 4. Thrombophilia test 10. Prolactin w/o

13 14 5. Immunological test symptoms http://www.choosingwisely.org/wp-content/uploads/2015/02/ASRM-Choosing-Wisely-List.pdf

FERTILITY TREATMENT Optimizing natural fertility

Initial Steps • Coital frequency/practices – Q1-2 days – Lubricants (mineral oil, canola oil, hydroxyethylcellulose-based) • Fertile window – 3 days ending on day of ovulation – OPK testing limitations • Diet/lifestyle

16 Optimizing natural fertility: a committee opinion. ASRM 2016. Fertil Steril 2017; 107:52-8.

Other reproductive surgery Tubal surgery • In women w/ pelvic pain, visible • Fair evidence (in young women w/ no other endometriosis observed during surgery significant fertility factors) should be treated – Tubal cannulation for proximal occlusion • Limited evidence, hysteroscopic septum – Laparoscopic fimbrioplasty or neosalpingostomy for mild resection may improve outcomes when hydrosalpinges infertility or RPL present • Good evidence • Fair evidence that myomectomy for – Removal of surgically irreparable cavity-distorting fibroids improves hydrosalpinges to improve IVF rates pregnancy and reduces EPL

Treatment of pelvic pain assoc with endometriosis: a committee opinion. ASRM 2014. 17 18 Uterine septum: a guideline. ASRM 2016. Role of tubal surgery in the era of ART: a committee opinion. ASRM 2015. Removal of myomas in asymptomatic patients to improve fertility and/or reduce miscarriage rate: a guideline. ASRM 2017 Ovulation induction Subclinical hypothyroid tx • Letrozole is first-line, off-label for OI in • TSH screening reasonable in infertility, diagnostic test for oligoovulation PCOS • If >4.0 mIU/L (or >reference), treat to <2.5 mIU/L while trying to conceive • Management of 2.5-4.0 mIU/L controversial, ASRM consider treatment, TPO Ab testing • 2019 RCT found no difference in LB treating • Hypogonadotropic hypogonadism should TPO+ women trying to conceive not respond to oral OI agents • Bromocriptine or cabergoline until pregnancy for hyperprolactinemia 19 20 Subclinical hypothyroidism in the infertile female population: a guideline. ASRM 2015. Legro RS et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med. 2014;371(2):119-29. Dhillon-Smith et al. Levothyroxine in Women with Thyroid Peroxidase Antibodies before Conception. N Engl J Med. 2019;380(14):1316-25.

At what age should Assume:7yearsbetweenpotentialegg freezingandattemptingconception, Unexplained infertility planned oocyte cryo be WOULDusedonorspermifnotmarried considered? – IUI w/o OS and OS w/o IUI

not more effective than 1 Age 26 - Highest LBR 0.9 expectant management Age 37 - Minimal benefit 0.8 over not freezing Maximum Benefit – Oral OS + IUI > expectant 0.7 - May be better LBR only 50% Age 30-33 with longer 0.6 • CC 100 – IUI best studied, - Best Age?

horizon Birth  0.5 - High LBR Freeze

Live - Significant LTZ – IUI equivalent 0.4 benefit NoFreeze – IVF as next step generally 0.3 0.2 Age 40+ - Small to no benefit recommended over 0.1 - LBR 20% (or less) 0 gonadotropin-IUI 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 Farquhar et al. TUI trial. Lancet 2018. Age Diamond et al. AMIGOs trial. NEJM 2015. Reindollar et al. FASTT trial. Fertil Steril 2010. AdaptedfromMesen etal.Optimaltimingforelectiveeggfreezing. 21 ASRM Guideline on Treatment of Unexplained Infertility expected 2019-2020 Fertil Steril 2015.

Thank You

Jamie Peregrine, MD, MS [email protected] University Fertility Consultants: 503-418-3700 Direct office line: 503-418-8137 Cell/text: 949-413-0337 Disclosures

• none

Cleaning Up the Mesh Examining the History of Transvaginal Mesh Use in Urogynecology

DATE: NOVEMBER 15, 2019 PRESENTED BY: IAN FIELDS, MD 2

Learning Objectives Let’s Start With a Quiz

1. Describe the evolution of transvaginal mesh use in urogynecology from its introduction in 1996 to present practice. 2. Understand recent Food and Drug Administration (FDA) warnings regarding transvaginal mesh and their implications on incontinence and prolapse repair surgeries. 3. Identify recent trends in mesh-augmented prolapse repair and anti-incontinence surgeries. 3 4

Turn on the TV Turn to Google

5 www.cbs.com 6 Go outside History of Mesh in Surgery

• 1894 – silver coils • 1900 – silver filigrees • 1948 – tantalum gauze • 1952 – stainless steel • 1954 – Fortisan • 1956 – polyester • 1957 – polyvinyl • 1958 - polypropylene

https://collection.cooperhewitt.org/objects/18679167/ www.gynsurgery.org/meshesh-pros-and-cons https://www.meshmedicaldevicenewsdesk.com/mesh-injured-speak- 7 their-truth-to-urogynecologists/ 8

Abdominal Sacrocolpopexy Abdominal Sacrocolpopexy

Transvaginal Mesh

https://www.researchgate.net/figure/Robotic-assisted-abdominal-sacrocolpopexy-RASC-mesh-secured-from-the- vagina-to-the_fig2_288022327 9 10

FDA Medical Device Regulation FDA 510(k) Process • Class I

– Bandages, gloves, surgical instruments • No trials; no requirement of clinical safety or

– Approval: Labeling, Good Manufacturing efficacy

• Class II • Allows the FDA to determine whether a device

– Catheters, wheelchairs, LSC trocars, mesh kits is equivalent to a device already placed on the for SUI and POP market – Approval: 510K process – Termed predicate devices • Class III • Predicate devices – on the market prior to May – Cardiac pacemakers, interstim, urethral bulking 1976

– Approval: Premarket Approval Study 11 12 It all begins in 1996

https://www.mpo- https://www.meshmedicaldevicenewsdesk.com/family-tree-of- mag.com/contents/view_top30/2016-07- meshes-from-the-female-patient-april-2009/ 13 19/12-boston-scientific/ 14

FDA Enforcement Report Where we meshed up

The IVS Tunneler Approved in April 2001 – Issued March 17, 1999 treatment of POP “Use of the ProteGen in the treatment of female urinary incontinence associated with a higher than expected rate of vaginal erosion and dehiscence, and appears not to function as intended”

https://www.researchgate.net/figure/S- Tunneller-with-polypropylene- tape_fig2_8068891

15 16

Where we meshed up Where we meshed up

The Perigee system The ProLift system

https://www.pinterest.com/pin/3132817178 https://www.meshmedicaldevicenewsdesk. 22680570/ com/mesigian-prolift-pelvic-mesh-trial- underway-in-philadelphia/

17 18 The Lawsuits Begin FDA MAUDE Database

www.fda.gov

19 20

FDA MAUDE Database FDA Public Health Notification

http://www.amiform.com/web/documents-risques-op-coelio-vagi/fda- www.fda.gov notification-about-vaginal-mesh.pdf 21 22

2010 – Prolift RCT Stopped FDA Update – July 2011

https://www.burgsimpson.com/wp-content/uploads/2018/03/FDA- https://www.semanticscholar.org/paper/Vaginal-Mesh-Kits-for-Pelvic- safety-communication-pelvic-mesh.pdf 23 Organ-Prolapse%2C-Friend-Moore- 24 Miklos/608f625b30edfcfcfbc968a18539ad5baa9583e7 Obstetrics & Gynecology Device Postmarket Surveillance Panel – September 2011

www.fda.gov www.fda.gov

25 26

AUGS 2012 Guidelines

www.acog.org www.augs.org

27 28

Gynecare Prolift Recalled

www.schmidtlaw.com www.acog.org

29 30 Outside the United States Pelvic Floor Disorders Registry

Blog.storyhunter.com Blog.storyhunter.com

31 32

Where Are We Now?

FDA, Coloplast, and Boston Scientific websites

33 34

Top 10 Medical Device Reports AUGS Best Practice Statement

www.fda.gov 35 36 ACOG Practice Bulletin What About Slings?

37 38

Beware! Where Does Blame Lie?

• Industry? – Marketing before R&D • Regulatory Bodies? – 510(k) process • Physicians? – Efficacy unclear • Academics? – Insufficient safety data

www.nytimes.com 39 40 https://www.dougtedder.com/2015/02/26/dont-point-that-finger-at-me/

Take Home Point

• Transvaginal mesh kits now banned by the FDA.

• Polypropylene mesh midurethral sling remains the standard of care for surgical management of symptomatic stress urinary incontinence.

• Mesh placed abdominally for the treatment of pelvic organ prolapse (ie. OHSUPhysicianAdvice&Referral Sacrocolpopexy) has not been restricted Service or banned by the FDA. • 503Ͳ494Ͳ4567 Thank You • 800Ͳ245Ͳ6478(tollͲfree) 41 42 Objectives

• Describe the concept of shared decision making and how its definition and implementation have changed over time • Be familiar with strategies for implementing Ethical Frameworks for Doing optimal shared decision making in clinical Shared Decision Making practice A How-To Guide • Understand the relationship between evidence- based guidelines, new research findings, and shared decision making.

DATE: November 15, 2019 PRESENTED BY: Michele Megregian, CNM

2

Shared decision-making when counseling July women about elective IOL is critical. 2019

The American College of Nurse- Midwives strongly endorses the need for shared decision-making and “These results suggest that policies aimed at the equitable access to evidence-based information to use in discussions avoidance of elective labor induction among low-risk between childbearing families and nulliparous women at 39 weeks of gestation are their health care providers

unlikely to reduce the rate of cesarean delivery on a Practice Advisory: Clinical guidance for integration of the population level; the trial provides information that findings of The ARRIVE Trial: Labor Induction versus can be incorporated into discussions that rely on Expectant Management in Low-Risk Nulliparous Women principles of shared decision making.” …this recommendation may be conditional upon the values and preferences of the pregnant woman, the resources available (including personnel), and the setting in which the intervention will be implemented. A collaborative discussion with shared-decision making should take place with the pregnant woman.

What do Women Say?

Chappell et al, 2019 • Conversations prenatally about possible interventions “In conclusion, our trial supports offering initiation of delivery in women with late – Decision Aids preterm pre-eclampsia. The trade-off of lower maternal morbidity and severe hypertension against higher neonatal unit admissions, albeit without additional respiratory or other morbidity, should be discussed with women with late preterm preeclampsia to allow shared decision making on timing of delivery.” • Inclusion in decision-making during labor “may be reasonable to offer … may – Staff training in communication and SDM techniques Prevention of Group B Streptococcal Early- consider discussing the option … as Onset Disease in Newborns ACOG CO #782 a shared decision making process in July 2019 * this clinical scenario”

• Debriefing

"However, this is a shared decision…” Human right to dignity P C A O Culture of safety in healthcare T N E S R U Respectful care N M A E Person L R Centered Care I I S S M M

SDM

NUDGING SHARED DECISION MAKING

Shared Decision Making Decision Aids in Maternity Care

Clinically Ļ Ĺ Ļ Anxiety Decisional Appropriate Knowledge Patient Conflict

Preference Decision Sensitive ? Final Ĺ Informed Ĺ Aid Choice / Condition Choice Satisfaction Outcome

9 10

Sharing … ? Preference Sensitive Condition

• More than one clinically Provider Woman Risk appropriate intervention or Biases strategy option exists perception • Expectant management • Each option has varying benefits Risk Preferences and drawbacks tolerance • Person’s values and preferences should be critical in determining Values / Expertise the chosen intervention. Goals • Evidence-based recommendations

• Risk perception & risk tolerance Legare et al 2013 11 12 SDM in practice SDM-Q9 Control Preferences Scale (CPS) • Validated • Originally designed to questionnaire assess patients’ preferences in decision • Measures making (1997) involvement in • Active Role (Patient) decision making – Informative Role (Provider) process from • Collaborative Role provider’s – Shared Decision Making perspective • Passive Role (Patient) • Preference – Paternalistic Role (Provider) Sensitive Condition Driever et al 2019 14

SDMQ-9 DOC I make it clear that a decision needs to be made Strongly Somewhat Somewhat Strongly Agree Neither Disagree Agree Agree Disagree Disagree 7 6 (30%) 5 (25%) 1 (5%) 1 (5%) 0 0 (35%)

I want to know exactly how my pt wants to be involved in DM Strongly Somewhat Somewhat Strongly Agree Neither Disagree Agree Agree Disagree Disagree 7 2 8 (40%) 2 (10%) 1 (5%) 0 0 (35%) (10%) I select a treatment option with my patients Strongly Somewhat Somewhat Strongly Agree Neither Disagree Agree Agree Disagree Disagree 5 11 (55%) 1 (5%) 1 (5%) 2 (10%) 0 0 (25%) *Adapted with permission; the SDM-Q-9 DOC is licensed under the Creative Commons Attribution- 15 NonCommercial-NoDerivatives 4.0 International License

Control Preference Scale: INDUCTION OF LABOR Provider Preferred vs Usual Role Preferred Role Actual Role • Informative Role • The patient makes the final decision about … • The patient makes the final decision about … , Informative 10 (53%) 14 (74%) but after considering my opinion. • Shared Role Shared 9 (47%) 4 (21%) • The patient and I share responsibility for making a final decision about ... Paternalistic 0 (0%) 1 (5%) • Paternalistic Role • I make the final decision about … , but after considering the patient’s opinion. • I make the final decision about … 17 18 ASA PROPHYLAXIS ACTIVE MANAGEMENT TSL

Preferred Role Actual Role Preferred Role Actual Role

Informative 7 (37%) 9 (47%) Informative 9 (47%) 10 (53%)

Shared 7 (37%) 7 (37%) Shared 10 (53%) 6 (31%) Paternalistic 5 (26%) 3 (16%) Paternalistic 0 (0%) 3 (16%)

19 20

DOING SHARED DECISION MAKING Screening for Decisional Conflict • Describe idea of choice & Team options Talk • Ask about goals • Sure: do you feel sure about the best decision for you?

Options • Risk communication • Uninformed: do you know the Talk • Self Efficacy benefits/risks of each option? • Risk/Benefit Ratio: are you clear about Decision • Make recommendations which benefits or risks matter more to you? Talk • Check/clarify understanding • Encourage: do you have enough support to

21 Elwyn et al BMJ 2017;359:j4891 doi.org/10.1136/bmj.j4891 22 make a decision?

Gaps Next Steps

¾Reflection: What is your preferred role in decision making? Conflicting Uncertainty Duty to Evidence (Anxiety) Offer ¾Preference Sensitive Conditions? ¾Authors: if you recommend SDM, identify the key points

Risk ¾Guideline influencers: Decision Aids! Prediction

24 References References

• Begley, et al. Shared decisionǦmaking in maternity care: Acknowledging and • Moore, et al. Moving Toward Patient-Centered Care: Women’s overcoming epistemic defeaters. J Eval Clin Pract. 2019;1–8. Decisions, Perceptions, and Experiences of the Induction of Labor • Van der Weijden, et al. How can clinical practice guidelines be adapted to Process. 2014 Birth 41:138-146 facilitate shared decision making? A qualitative key-informant study. BMJ • Stevens, et al. Patient decision aids in routine maternity care: Qual Saf 2013;22:855–863 Benefits, barriers, and new opportunities. 2016 Women and Birth • Légaré, et al. Interventions for increasing the use of shared decision making by healthcare professionals. Cochrane Database of Systematic Reviews 2018, 29: 30–34 Is 7 • Schwarz, et al. Women’s perceptions of induction of labour • Land, et al. Communication practices that encourage and constrain shared outcomes: Results of an online-survey in Germany. Midwifery, 2016 decision making in health-care encounters: Systematic review of 35:3–10 conversation analytic research. Health Expectations. 2017;20:1228–1247 • Driever, et al. Shared decision making: physicians’ preferred role, • Beach M, Sugarman J. Realizing Shared Decision-making in Practice. JAMA, usual role and their perception of its key components. PEC, 2019 2019 322(9):811-812 • Degner, et al. The Control Preference Scale. Canadian Journal of Nursing Research, 1997 29(3):21-43

25 26

Thank You [email protected] Disclosures

Maternal Morbidity & Mortality Taking Action on the State Level • CDC Cooperative agreement NU58DP006358 • AIM Participation DATE: MONTH 22, 2015 PRESENTED BY: RACHEL PILLIOD, MD

Learning Objectives Why all the fuss… now? • 19th Century – 7 deaths per 100 births 1. Describe the trends in maternal • 20th Century morbidity and mortality over the – Home to hospital last 20 years and the growing – Aseptic technique disparities in health outcomes. – Antibiotics 2. Understand the purpose of state – based quality improvement efforts Oxytocin in perinatal care – Transfusion medicine 3. Identify the current and planned – Antihypertensive medications statewide initiatives run by the • Improvements in Europe, US & Canada Oregon Perinatal Collaborative

Why all the fuss... now?

Lancet, 2015 & graphics courtesy ProPublica Pro-Publica & National Focus • MFMU: 4/34 initiatives primarily target women, while 24 aimed at infants • Title V Maternal Child Health Block Grants: 6% of grants in 2016 aimed at women, 78% for infants and children • Medicaid Funding & Pregnancy Care – Eligibility thresholds – Documentation status & CHIP – Postpartum cut offs • Joint Commission Perinatal Core Measures – 1/6 focused on maternal health (CS rates)

How do we know what we know? How do we know what we know? • Pregnancy-Related Death (CDC) – the death of a woman while pregnant or within 1 year • Pregnancy-Related Mortality Ratio of pregnancy termination, regardless of the duration or site of the pregnancy, from any (CDC) – an estimate of the number cause related to or aggravated by the of pregnancy-related deaths for pregnancy or its management, but not from every 100,000 live births accidental or incidental causes • Pregnancy-Related Death (WHO) – the death • Maternal Mortality Ratio (WHO) – of a woman while pregnant or within 42 The number of maternal deaths days of termination of pregnancy, per 100,000 live births irrespective of cause of death

• ~700 die annually in the US (PMSS data) • Overall PRMR 16.7 pregnancy related deaths per How do we know what we know? 100,000

• Current methods to identify maternal deaths are problematic... • Are maternal deaths really increasing?

Creanga, Clin Obstet & Gynecol. 2018 Petersen EE, et al. MMWR, 2019, Creanga, Clin Obstet & Gynecol. 2018 Can we believe the trend? • We are more sick • Socioeconomic factors • CS rates • Selection bias for CPD overcome by CS • Disparities in care and outcomes

Improvement in ascertainment methods? • 2003 Death Certificate Check Box • ICD-9ÆICD-10

Creanga, Clin Obstet & Gynecol. 2018

Can we believe the trend?

• We are more sick • Socioeconomic factors • CS rates • Selection bias for CPD overcome by CS • Disparities in care and outcomes

Improvement in ascertainment methods?

Despite uncertainty: risk of death during and shortly after pregnancy from pregnancy related causes has not declined in the US for Joseph, Obstet more than 25 years Gynecol, 2018

Causes of Maternal Death

• Serious morbidity vs mortality • The when matters (<42 days, within 1 year) • The where matters • The who matters: age, education, marital status, insurance status

Race || Ethnicity || Nativity Creanga, Clin Obstet & Gynecol. 2018 Creanga, Obstet & Gynecol. 2017

Racial/Ethnic Disparities Differences in leading cause of Death • NH black women 3-4 times more likely to die from pregnancy related causes than NH Non-Hispanic white Non-Hispanic black white women • Native Americans, Native Alaskans, 1. CV conditions(15.5%) 1. Cardiomyopathy (14.0%) Asians/Pacific Islanders, Latina women also 2. Hemorrhage (14.4%) 2. CV conditions (12.8%) face disparities 3. Infection (13.4%) 3. Pre-/eclampsia (11.6%) 4. Mental Health (11.3%) 4. Hemorrhage (10.5%) • Regional variation: 12 fold higher risk of 5. Cardiomyopathy (10.3%) 5. Embolism (9.3%) pregnancy related death for NHB than NHW • For every maternal death, 100 women suffer a severe obstetric morbidity, life threatening diagnosis or undergo a lifesaving procedure during hospitalization

Peterson, MMWR, 2019 CDC, 9 MMRCs. 2018 Howell, Clin Obstet & Gynecol. 2018

Disparities in Maternal Mortality • NH black case fatality rate 2.4-3.3 times higher than that of NH white women for: – Preeclampsia – Eclampsia – Placental abruption – Placenta previa – Postpartum hemorrhage

Tucker, Am J Public Health. 2007 Howell, AJOG. 2016 Disparities in Maternal Mortality So what is being done?

Social • Fellowship Training Underlying determinants disease of health – ICU, L&D, D&C Training • CDC & HRSA Funding • Public Awareness & Quality Metrics Hospital Factors • Maternal Levels of Care (LOCATe) • Maternal Mortality Review Committees (MMRCs) • Growth of Perinatal Quality Collaboratives (PQC) Maternal Mortality

Levels of Maternal Care • IntroducedbySMFM andACOGin2015 • Fourdesignationsfor Level I: Basic Care maternitycare hospitalsbasedon Level II: Specialty Care nursing,provider,and facilityresources Level III: Subspecialty Care

Level IV: Regional Perinatal Care

• Hospitalvolume&Accesstospecialtyprovidersare knowntoaffectobstetricoutcomes • Statesarebeginningtoimplementthelevelsof maternalcarebutlimiteddataexistsyetontheirutility orabilitytoimprovematernalcare Clapp; AJOG 2018

Significant interaction between patient risk and hospital acuity --> patient outcomes

Risk ratio of experiencing SMM among Maternal Mortality Review high-risk patients was greater in low acuity hospitals compared to high acuity hospitals, • 1930 -- New York Academy of supporting the concept of regionalization Medicine & Philadelphia County Medical Society • 1968 – 44 states + DC • 2012 – 18 states + Philadelphia • 2019 – 34 states + Philadelphia & NYC • Planning: 10 states + Puerto Rico

Clapp; AJOG 2018 Slide courtesy Julie Zaharatos, CDC Maternal Mortality Review Maternal Mortality Review

• Authority to access data • Confidentiality and protection of collected data, proceedings and activities • Immunity for committee members • Regular reporting and dissemination of findings • Multidisciplinary committee with local input

Slide courtesy Julie Zaharatos, CDC

Maternal Mortality Review Maternal Mortality Review Slide courtesy Julie Zaharatos, CDC

Maria I. Rodriguez, MD, MPH – Chair

17 Cases for review

MMRC -9 states MMRC – 9 States

CDC, 9 MMRCs. 2018 CDC, 9 MMRCs. 2018 The Birth of PQCs Vermont Oxford Network California Perinatal Quality Care Collaborative

CDC, 9 MMRCs. 2018

CMQCC Sets the Standard

Maternal data center with 200 hospitals representing 90% of California births • QI improvement projects, toolkits – Hemorrhage – Venous thromboembolism – Severe hypertension – Reducing disparities • Reduced Maternal Mortality Ratio by 55% from 16.9 in 2006 to 7.3 in 2013

Ozimek, Obstet Gynecol Clin N Am. 2018

OPC Vision Everyone in Oregon will have access to and receive high-quality maternal and neonatal care to optimize health.

Success of California and other leading states • 2017 Additional CDC Funding – 13 states: Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oregon, Wisconsin • National Network of Perinatal Collaboratives OPC Mission: We work together to advocate for improved maternal and childhood health outcomes through collaboration, implementation of evidence-based practices, and policy change throughout the state of Oregon.

Where do we start? ProPublica: Advice From Mothers Who Almost Died

• ~700 die annually in the US (PMSS data) • Overall PRMR 16.7 pregnancy related deaths per 100,000

“While my doctor was amazing, we live in a “If you have a hemorrhage, don’t clean up smaller town and they don’t carry enough after yourself! Make sure the doctor is fully blood/platelets on hand for very emergent aware of how much blood you are losing. I had a situations. They have patients shipped to larger very nice nurse who was helping to keep me hospitals when they need more care. Had I been clean and helping to change my (rapidly filling) aware of that we would have decided to deliver at pads. If the doctor had seen the pools of blood a larger hospital so in case something happened himself, rather than just being told about them, to me or our daughter we wouldn’t be separated, he might not have been so quick to dismiss me.” which we were when I was life-flighted out.”

— Valerie Bradford, 30, survived hemorrhage in 2016 — Kristina Landrus, 26, survived hemorrhage in 2013 “Key pieces of information every woman should Provider Fall Out – the 2nd Victims know before choosing a hospital are: What are “No matter how much you fool yourself you are their safety protocols for adverse maternal over something, and maybe even though I hadn’t events? No one likes to think about this while thought of it for months, I had that woman’s name seared into my memory and as soon as I pregnant, and providers will probably tell you saw that name, my chest was up in my throat.” that it’s unlikely to happen. But it does happen and it’s good to know that the hospital and “I still think about it. Just randomly you forget and then something will happen and it just pops providers have practiced for such scenarios and into your head. You go over it again, what could I have protocols in place.” have done differently, what could I have said, what should I have done?” — Marianne Drexler, 39, survived hemorrhage and hysterectomy in 2014

OB Hemorrhage Deeply Felt Widely Felt

OB Hemorrhage Campaign

Oregon at a Glance OB Hemorrhage Statewide Launch • ~42,600 births 2018 • Birthrate declined x2 years • 2026 (deaths > September 2018 – Perinatal Summit (VTE, births) HTN, IOL, Hemorrhage) March 2019 – Steering Group Convened Unique Populations • Community or Home May 2019 – AIM State Application Births • Rural | Frontier | June-August 2019 – Planning, materials, Critical Access generating interest July-August 2019 – Baseline survey Total Births County 48 Hospitals w/OB Service Adventist 777 Multnomah Lines Asante – Ashland 253 Jackson • 22 responded Asante Rogue Regional Medical Center 1606 Jackson • 18 expressed interest Good Samaritan Regional Medical Center 940 Benton OB Hemorrhage Statewide Launch • 55% of births statewide Samaritan Albany General Hospital 536 Linn Samaritan Lebanon Community Hospital 281 15 community birth Linn providers Samaritan North Lincoln Hospital 145 Lincoln • Largely from Samaritan Pacific Communities Hospital 164 Lincoln September 2018 – Perinatal Summit (VTE, HTN, IOL, independent practices, Harney District Hospital 39 Harney Hemorrhage) not birth center based Kaiser Westside Medical Center 1527 Washington facilities March 2019 – Steering Group Convened • QI Experience Legacy Emanuel Medical Center 1826 Multnomah • Majority have policies Legacy Good Samaritan Medical Center 984 Multnomah May 2019 – AIM State Application which are followed most Legacy Meridian Park Medical Center 961 Clackamas June-August 2019 – Planning, materials, generating of the time (range 25- Legacy Mt Hood Medical Center 915 Multnomah 100%) • Majority kept statistics, LegacySilvertonMedicalCenter 1346 Marion interest most referenced MANA Mercy Medical Center 857 Douglas July-August 2019 – Baseline survey stats. Providence Medford Medical Center 476 Jackson Providence Portland Medical Center 2882 Multnomah September 2019 – Follow up, letter of commitment, Providence Seaside Maternity Services 95 Clatsop speaking engagements Salem Health 3386 Marion th Tuality Community Hospital 577 Washington October 28-29 – Statewide kickoff & Team training Willamette Valley Medical Center 427 Yamhill INITIATIVE LAUNCHED! Oregon Health & Science University 2291 Multnomah

Key Elements of Participating

Identifyamultidisciplinaryteamatyourhospitaltoactivelychampion bundleimplementation

AssureZoom capability(Zoomallowsuserstomeetvirtually.Clickonbelowlinkfor ashorttutorial

Committoattendatleast80%oftheOBHemorrhagesessions(atleastone memberofteamoneach session)

Committopresentatleastonepatientorsystemscaseper team(includeamountof times/frequencyparticipantswillbeexpectedtopresentoncedeterminedbythe group)

Meetmonthlyasahospitalteamtoreviewyourprogressand data

AttendtheOPCannualsummitinOregonCityonMonday10/28/19(asmany aspossiblefromyour team)

AttendtheOBHemorrhageAIMhalfͲdayinPortlandonTuesday10/29/19(at leastteamlead)

CHECKLIST: One Time Only Are these elements in place? OB Hemorrhage Initiative If already in place, have we reviewed them? • 18 Structure Measures (Once) • 5 Process Measures (Quarterly) Quarterly: Education & – Unit Drills Drill/Simulation Efforts – Provider Education – Nursing Education – Risk Assessment Monthly Case Review: – QBL Is screening & QBL • 4 Outcome Measures (Monthly) happening? – SMM Are briefs & debriefs – SMM, excluding transfusions happening? – SMM among hemorrhage cases Any issues you are – SMM excluding transfusions among hemorrhage succeeding or struggling in? cases

Data Trend: Comagine/OMDC Adventist Multnomah Asante – Ashland Jackson Asante Rogue Regional Medical Center Jackson Good Samaritan Regional Medical Center Benton Samaritan Albany General Hospital Linn Samaritan Lebanon Community Hospital Linn Samaritan North Lincoln Hospital Lincoln Samaritan Pacific Communities Hospital Lincoln Kaiser Sunnyside Medical Center Clackamas Kaiser Westside Medical Center Washington Legacy Emanuel Medical Center Multnomah Legacy Good Samaritan Medical Center Multnomah Legacy Meridian Park Medical Center Clackamas Legacy Mt Hood Medical Center Multnomah LegacySilvertonMedicalCenter Marion Oregon Health & Science University Multnomah Providence Portland Medical Center Multnomah Providence Seaside Maternity Services Clatsop Salem Health Marion Tuality Community Hospital Washington

OB Hemorrhage Other Projects

• Join! • Opioid Use Disorder • Thought leadership/cultural shift • Family Well Being Assessment & • Refer your patients Social Determinants of Health • Rural Health & OB Ready Projects • Spread the word • Maternal Levels of Care • Implicit bias training

www.oregonperinatalcollaborative.org

Questions? Thank you

[email protected] [email protected] Thank You