Abstracts from Women's Health 2018: Translating Research into Clinical Practice May 4–6,2018 Washington,DC

1. Have We Been Barking Up the Wrong Tree? The Use of a Standardized Formulation of French Maritime Pine Bark Extract for the Treatment of Vasomotor Symptoms in Perimenopausal Women

Brown Louise TriangleRxConsult, LLC

Background: Hormone therapy is the most effective treatment for relieving moderate to severe vasomotor symptoms, yet many women choose not to use this class of medications due to concerns about their safety. Instead, they self-medicate with herbal products that have not been subjected to rigorous regulatory review. A lack of safety information on these products does not equate to their safe use. However, a standardized concentration of French maritime pine bark extract (Pinus pinaster) proprietary name containing 70 ± 5% procyanidins, consisting of condensed catechin and epicatechin, has been studied in a randomized, double-blind, placebo-controlled trial. Positive outcomes from this study, combined with previous findings from in-vitro, animal and human pharmacological studies demonstrating pine barks potent antioxidant and anti-inflammatory properties through inhibition of cyclo-oxygenase enzymes 1 and 2, suggest it may be a safe and effective alternative for middle aged women suffering with vasomotor symptoms, and may have additional long-term health benefits. The objective of this abstract is to review the available literature for animal and clinical studies that investigated the safety and efficacy of French maritime pine bark for the treatment of menopause-related symptoms. In addition information on other non-menopausal uses is presented.

Methods: An extensive literature search was performed using the Pubmed system, Google scientific and derived articles. The articles were critically reviewed by analyzing the evidence of possible effectiveness and reported safety regarding menopausal and non-menopausal symptoms and women's health. This review investigates present knowledge on the use of a standardized, proprietary formulation of French maritime pine bark.

Results: A randomized, double-blind, placebo-controlled trial of 200 Taiwanese perimenopausal women was conducted to evaluate the safety and efficacy of pine bark extract 200 mg daily, on menopausal related symptoms. Subjects were asked to self-report their level of discomfort using the Women's Health Questionnaire (WHQ). The WHQ is a reliable and validated 36 question instrument designed to measure physical and emotional menopausal symptoms. Consistent statistically significant improvements (p < 0.001) from baseline were seen in all WHQ domains and questions after one month in the treatment group. In comparison, the placebo group only the question addressing poor memory showed a consistent statistically significant change from baseline. When scores from the two groups were compared, women treated with pine bark extract consistently reported improvements that were superior to placebo at a significance level of p < 0.01 and p < 001. The difference between the two groups remained statistically significant throughout the six months of treatment. There were no reports of adverse events (AE). Additional findings in the treatment group included reductions in LDL cholesterol and blood pressure. Pine bark extract has been studied in over 5000 women in various doses and multiple indications. There are no reports of serious AEs in any clinical study or from commercial use since its introduction in Europe around 1970. Most research has focused on areas relating to improvement in vascular health. Limited published data is available to support the use of pine bark extract for thrombosis, diabetes, asthma, attention deficit hyperactivity disorder, endometriosis and osteoarthritis.

Conclusions: In the United States French maritime pine bark extract is considered a dietary supplement under the Dietary Supplement Health and Education Act of 1994. According to the FDA, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces hot flashes and night sweats”. This is an important distinction between prescription drugs and dietary supplements. Although pine bark extract is not classified as a drug, a standardized proprietary formulation has been studied in over 70 clinical trials in doses ranging from 20 mg to 360 mg daily, with efficacy seen in conditions ranging from retinopathy to chronic venous insufficiency. As of October 2006, the global frequency rate of AEs was 2.4%. Results from a randomized placebo controlled trial, provides insight on the use of a standardized formulation of pine bark extract, for perimenopausal women living with menopausal symptoms. Consistent statistically significant improvements were seen in scores rating a range of menopausal symptoms including depression, vasomotor symptoms, memory and concentration, attractiveness, anxiety, sexual behavior, sleep and menstrual problems. The lack of AE reports in the study is concerning and questionable. These findings are encouraging for perimenopausal women dealing with bothersome menopausal symptoms, who are reluctant or unable to take hormone therapy. Based on the available literature, a standardized formulation of maritime French bark extract 200 mg daily, maybe an effective and safe alternative option for these women. Additional research is warranted.

2. Perceptions and Attitudes About Low Sexual Desire Among Premenopausal Women: Results from a Consumer Survey

Kingsberg Sheryl PhD 1 Krychman Michael MD 2 Kissling Robert MD 3 Dib Allan BS 4

1 Case Western Reserve University, 2 Southern California Center for Sexual Health and Survivorship Medicine, Inc, 3 Valeant Pharmaceuticals North America LLC, 4 W2O Group

Background: The objective of this survey was to assess awareness, perceptions, and experiences of low sexual desire in premenopausal women.

Methods: US women aged 21 to 50 years without menopause symptoms were eligible to complete an online survey, which was conducted from July 1–14, 2016. Hypoactive sexual desire disorder (HSDD) was identified using responses to questions based on diagnostic criteria (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision).

Results: A total of 2501 premenopausal women responded to the survey; 54% reported lower sexual desire than in the past and 10% met HSDD criteria. Overall, mean age was 34.6 years; 58% of respondents were white. Respondents attributed low sexual desire to physical (80% of respondents without low sexual desire, 81% of those who met HSDD criteria), psychological (81% and 87%, respectively), and relationship (69% and 59%, respectively) causes. In women who met HSDD criteria, 71% reported that their low sexual desire had put a strain on their romantic relationship; other aspects of life negatively affected by low sexual desire included self-esteem (35%), confidence (24%), and mood (19%). Only 20% of women who met HSDD criteria had consulted a health care professional about their low sexual desire. The most common reason for not speaking to a medical professional was discomfort/embarrassment (37% of respondents who met HSDD criteria). Furthermore, only 11% of respondents who met HSDD criteria were aware of any treatments for low sexual desire.

Conclusions: HSDD places a considerable burden on affected women. The prevalence of women who met HSDD criteria in this survey was consistent with previous studies. Although most premenopausal women who met HSDD criteria identified physical and psychological causes of low sexual desire, few had discussed this issue with a health care provider, often because of embarrassment and/or lack of awareness of treatment options.

3. Wearability of a Once-Weekly Low-Dose Contraceptive Patch in the Phase 3 Secure Study

Simon James A. MD 1 Castaño Paula M. MD, MPH 2 Chen Beatrice A. MD, MPH 3 Garner Elizabeth I.O. MD, MPH 4

1 George Washington University, Women's Health & Research Consultants, ^®, 2 Columbia University Irving Medical Center, 3 University of Pittsburgh/Magee-Womens Research Institute, 4 Agile Therapeutics

Background: AG200-15 (levonorgestrel and ethinyl estradiol; Twirla^®) is an investigational transdermal contraceptive delivery system. The primary objective of this analysis was to examine wearability of the AG200-15 patch.

Methods: The SECURE study was a single-arm, open-label, 13-cycle, Phase 3 study conducted in US women aged = 18 years (NCT02158572). A 28-day cycle consisted of consecutive administration of three 7-day patches followed by 7 days off-treatment. Participants reported patch adhesion and irritation/itching daily in electronic diaries, and investigators evaluated these parameters at each visit. Adhesion scores ranged from 0 (no/minimal detachment) to 4 (complete detachment); irritation/itching scores ranged from 0 (none) to 3 (severe).

Results: A total of 2031 women wore at least 1 patch and were included in the safety population. Over 13 cycles, most investigators and participants reported adhesion scores of 0/1 (99.4% and 88.7%, respectively), indicating no detachment to some edges showing lift-off. Participant-reported adhesion scores improved over time (0/1 score: Cycle 2, 84.1%; Cycle 13, 92.5%). 5.0% of the cumulative number of patches applied during the trial completely detached. AG200-15 patch use resulted in low rates of moderate/severe irritation reported by investigators (2/3 score: Cycle 2, 0.2%; Cycle 13, 0.3%) and participants (Cycle 2, 6.9%; Cycle 13, 4.7%) and low rates of itching reported by participants (Cycle 2, 13.1%; Cycle 13, 9.6%). Discontinuation rates due to application site irritation or itching were low (23/2031 [1.1%] and 16/2031 [0.8%], respectively).

Conclusions: Participant and investigator assessments demonstrate favorable AG200-15 patch wearability, with high adhesion rates and low rates of irritation/itching.

4. Women's Satisfaction and Primary Reason for Choosing Their Current Contraception Method by Contraception Type

Hirth Jacqueline PhD 1 Dinehart Erin BS 2 Lin Yu-Li MS 3 Kuo Yong-Fang PhD 4 Patel Pooja MD 5

1–5 University of Texas Medical Branch

Background: Birth control satisfaction has been inadequately explored in the literature. The purpose of this study was to examine satisfaction and dissatisfaction with birth control methods among a large sample of young women.

Methods: We assessed contraception users' satisfaction with their primary method of birth control using an online survey. Contraception users were recruited through ads posted on social media. Participants were compensated with $5 Amazon gift codes. Females 16–25 years old using their current birth control method for 2 months or more were eligible. The data were stratified by contraception type, including: hormonal contraception (oral birth control pills, implant, Depo-Provera, the patch, or vaginal ring), Copper T IUD users, hormonal IUD users (Skyla, Liletta, or Kyleena), Mirena users, and non-hormonal contraception (cervical cap, diaphragm, condoms only, sponge, or spermicide). Method satisfaction, plans to discontinue current contraceptive method, and primary reason for using current contraceptive method were examined and compared between groups using chi-square analyses.

Results: A total of 2,714 participants took the survey, with all US states represented. Satisfaction was high, with 89.5% reporting being satisfied, although differences by type were found (p < 0.001). Common reasons for dissatisfaction were related to side effects or mood changes. We found 22.2% of hormonal contraception users, 20% of Copper T users, 17.8% of hormonal IUD users, 16% of Mirena users, and 2.4% of non-hormonal contraception users were “likely” or “very likely” to switch methods in the next year (p < 0.001). Less than half felt that the primary reason for choosing their current birth control method was to prevent pregnancy.

Conclusions: There are many different reasons why women use their method of birth control, and users may be dissatisfied based on side effects. Therefore, providers should consider discussing different types of birth control based on each patient's priorities and concerns, in addition to addressing effectiveness.

5. Gait and Balance in Aging Women: Alternative and Innovative Resources

Khanuja Kavisha BS 1 Bachmann Gloria MD 2 Joki Jaclyn MD 3 Cuccurullo Sara MD 4

1–4 RWJMS

Background: On a global level, people 65 years of age and older experience falls more frequently than younger individuals, which often result in severe injuries as well as increased healthcare costs. Women, in particular, are more likely to experience falls and be treated for fall injuries in the hospital setting compared to men. Gait and balance disorders in this population are among the most common causes of falls and negatively influence quality of life and survivorship. Although guidelines/recommendations are available to physicians to aid their elderly patients on fall-risk, many clinicians lack knowledge of available resources and appropriate interventions to prescribe. This project aims to identify the most effective assessments, resources, and strategies for healthcare workers to recommend and looks at innovative programs and technology currently in development that will play a role in helping patient. Resources will be categorized into a three tiers of fall prevention model that physicians can implement when evaluating their patients for balance and gait problems.

Methods: This comprehensive review aims to identify current effective assessments, resources, and tools utilized in improving balance and gait, in addition to upcoming and technological advancements in the field. A search of PubMed, Clinical Key, and Google Scholar was conducted using the key words such as “balance and gait training”, “fall interventions”, “Balance and gait evaluations”, “wearables and robotics”, and “exergaming” to yield articles published in peer-reviewed, English language journals up till October 2017. Systematic reviews, RCTs, and meta-analyses were selected for, and in their absence clinical trials were used.

Results: Resources falling under tier 1 involve assessment of all elderly patients over the age of 65 and an understanding of various harms and risk factors involved falls. Multifactorial assessments in addition to an office-setting test like the modified 30 second Sit to Stand test provide information regarding risk of fall. Technological advancements, such as usage of accelerometer-based body worn monitors (BWM), smartphone applications, and rehabilitation robots may in the nearby future more accurately examine balance and better differentiate aspects of gait and balance. Tier 2 resources focus maintaining current health of the patient and preventing future falls. Several studies have found practices, such as Yoga and Tai Chi, to be cost effective modalities that improve balance and reduce the risk of falls. Exergaming technology is also development as an alternative exercise method that can be done at home. Preliminary research has found the use of exergaming to have positive outcomes on balance ability. If a patient has already experienced a fall, interventions falling under tier 3 can be implemented. Multifactorial interventions that have shown to be effective in several studies include Matter of Balance, Community Aging in Place-Advancing Better Living for Elders, and modified boxing classes. The usage of robotic devices in rehabilitation is currently being explored. Projects, such as V-Time and BALANCE, are working on building virtual reality devices and exoskeletons that will assist patients' with postural control and improve balance and overall function.

Conclusions: Because falls are a major public health concern and injuries sustained secondary to falls can have devastating impact on function and quality of life, particularly for older women, poor gait and balance can diminish a patient's Healthy Aging Phenotype. Utilizing a three-tiers of fall prevention model to categorize patients may help providers determine which available resources are best suited for their patient's current needs and health function. The goal is to not only prevent falls, but also to slow the progression of changes associated with aging, and help older women maximize their overall function, independence, and quality of life. Technology over the next 10 years should hopefully provide many more options for assessment, prevention and intervention in this area of health care.

6. Efficacy of Bremelanotide for HSDD in Women: Reconnect Open-Label Extension Phase Results

Clayton Anita MD 1 Kingsberg Sheryl PhD 2 Simon James MD 3 Jordan Robert BS 4 Lucas Johna MD 5

1 University of Virginia, Charlottesville, VA, USA, 2 University Hospitals Case Medical Center, Cleveland, OH, USA, 3 George Washington University and Women's Health & Research Consultants, Washington, DC, USA, 4,5 Palatin Technologies, Inc., Cranbury, NJ, USA

Background: Bremelanotide (BMT), an investigational new drug, is a melanocortin-4-receptor agonist that has demonstrated acceptable safety and efficacy compared with placebo (PBO) in the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women in the RECONNECT studies. Here we evaluate the sustained treatment effect of BMT on HSDD during the open-label safety extension (OLE) phase of the RECONNECT studies.

Methods: After completion of the double-blind, placebo-controlled, Core Study phase of RECONNECT (301 and 302 studies), subjects were eligible to enroll in the 52-week OLE Study phase. BMT 1.75 mg was self-administered as desired via an auto-injector pen. All efficacy analyses in OLE were descriptive, and the same co-primary efficacy endpoints were evaluated as in the Core Study: desire was measured by the FSFI desire domain score (FSFI-D), and distress associated with low desire was measured by the FSDS-DAO Q13. Data were collected during clinic visits occurring at 4- to 8-week intervals. OLE baselines for the BMT and PBO groups were Core Study baseline and end of Core Study, respectively.

Results: Among the 856 subjects who completed the RECONNECT Core Studies, 684 (79.9%) subjects (254 from the BMT group and 430 from the PBO group) were enrolled in the OLE Studies. In OLE Study 301, at week 52 of BMT treatment, subjects who had received BMT or PBO in the initial Core Study demonstrated respective mean changes from group baseline of 1.30 and 0.77 in FSFI-D, and 1.7 and 0.9 in FSDS-DAO Item 13. OLE Study 302 showed similar results, with subjects who had received BMT or PBO in the initial Core Study demonstrating respective mean changes from baseline of 1.25 and 0.70 in FSFI-D, and 1.4 and 0.9 in FSDS-DAO Item 13 at week 52 of BMT treatment in the OLE Study. Similar trends were also observed for multiple secondary endpoints. Among the 684 subjects enrolled in the OLE Studies, 272 (39.8%) subjects completed the 52-week treatment period. The most common treatment-emergent adverse events (TEAEs) in OLE Studies 301 and 302 were nausea (42.7% and 37.7%, respectively), flushing (24.5% and 16.2%, respectively), and headache (12.1% and 11.8%, respectively). In the 2 respective OLE Studies, 23.4% and 18.7% of subjects prematurely discontinued study drug due to TEAEs, similar to the Core Studies.

Conclusions: Regardless of treatment group during the initial 24-week PBO-controlled Core Study phase, BMT provided consistent, sustained treatment benefits in premenopausal women with HSDD for the duration of the year-long RECONNECT OLE Studies. BMT was generally well tolerated, with no new safety signals identified.

7. Bremelanotide for Hypoactive Sexual Desire Disorder: Age and Weight Subgroup Efficacy Analyses (Reconnect Studies)

Simon James MD 1 Kingsberg Sheryl PhD 2 Clayton Anita MD 3 Jordan Robert BS 4 Lucas Johna MD 5

1 George Washington University and Women's Health & Research Consultants, Washington, DC, USA, 2 University Hospitals Case Medical Center, Cleveland, OH, USA, 3 University of Virginia, Charlottesville, VA, USA, 4,5 Palatin Technologies, Inc., Cranbury, NJ, USA

Background: Bremelanotide (BMT), an investigational new drug, is a melanocortin-4-receptor agonist that has demonstrated acceptable safety and efficacy in the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women in the RECONNECT studies. In this ad hoc analysis, BMT efficacy was investigated within age and weight subgroups.

Methods: Subjects from the two phase 3 RECONNECT studies were divided into age and weight quartiles. After a 4-week placebo (PBO) run-in period, subjects self-administered 1.75 mg BMT via an auto-injector pen, as desired, or equal volume PBO for 24 weeks. Efficacy was assessed using FSFI and FSDS-DAO scoring systems; FSFI desire domain (FSFI-D) and FSDS-DAO distress resulting from low desire (Item 13) were the co-primary endpoints.

Results: For the total population (N = 1267), the difference in FSFI-D mean changes from baseline (BMT-PBO) was 0.36. Differences in mean FSFI-D changes from baseline for each age quartile (n-value range: 136–172) were 0.22 (19–33 years), 0.36 (>33–39 years), 0.55 (>39–44 years), and 0.30 (>44–56 years). Differences in mean FSFI-D changes for each weight quartile (n-value range: 142–159) were 0.25 (39.8–63.1 kg), 0.39 (>63.1–73.5 kg), 0.35 (>73.5–87.6 kg), and 0.40 (>87.6–189.9 kg). Significantly greater (P < 0.05) changes in FSFI-D were achieved with BMT vs PBO across all age and weight quartiles with the exception of the 19–33 years age quartile (P = 0.05). FSDS-DAO Item 13 was also significantly improved across age and weight quartiles with the exception of the 39.8–63.1 kg (P = 0.10) weight quartile. Similar results were observed in the phase 2b dosing-finding study.

Conclusions: In an integrated analysis from the two phase 3 clinical studies, BMT demonstrated efficacy (increased desire as measured by FSFI desire domain) in premenopausal women with HSDD independent of age or weight. In addition, BMT decreased distress associated with low desire (as measured by the FSDS-DAO Q13 score) across all age groups and all weight groups except one (39.8–63.1 kg).

8. Exit Survey Study Data of Women with HSDD Treated with Bremelanotide Demonstrated Meaningful Treatment Benefits

Koochaki Patricia PhD 1 Revicki Dennis PhD 2 Wilson Hilary PhD 3 Pokrzywinski Robin PhD 4 Jordan Robert BS 5 Lucas Johna MD 6

1–4 Evidera, Bethesda, MD, 5,6 Palatin Technologies, Inc., Cranbury, NJ

Background: Bremelanotide (BMT), an investigational new drug, is a melanocortin-4-receptor agonist that has demonstrated clinically meaningful improvements in desire and the distress associated with low desire in premenopausal women with hypoactive sexual desire disorder (HSDD) in two phase 3 studies (RECONNECT). Here we present outcomes from exit surveys completed by a subset of subjects from RECONNECT studies, with a focus on the patient perspective on the impact of treatment benefit.

Methods: Study subjects were randomized to self-administer BMT (1.75 mg) or placebo (PBO) subcutaneously via an auto-injector pen as desired prior to sexual activity for 24 weeks (Core Studies). Upon study completion, 242 subjects completed evaluable quantitative exit surveys for analysis (102 BMT and 140 PBO).

Results: Among subjects who completed the survey, mean (SD) duration of HSDD was 55.2 (48.1) months at study enrollment; symptoms at baseline included decreased sexual interest and desire, decreased arousal, changes in sexual satisfaction/orgasm, and physical changes in lubrication. Overall meaningful benefit, as determined using the exit survey, was seen in 58.8% of the BMT group and 27.1% of the PBO group (P < 0.0001). The BMT group reported a meaningful increase in sexual desire and responsiveness to their partners initiating sexual activity (51.0% and 53.9%, respectively) compared with PBO (20.7% and 25.7%, respectively; P < 0.0001 for both). Treatment with BMT compared with PBO was associated with significant improvement in sexual satisfaction (56.9% vs 25.7%; P < 0.0001), and meaningful improvements in mental (52.0% vs 25.7%; P < 0.0001) and physical (64.7% vs 21.4%; P < 0.0001) arousal. Overall, 62.4% of participants rated their experience with the auto-injector device as excellent or very good.

Conclusions: Results from the quantitative exit survey showed that women randomized to BMT consistently reported meaningful treatment benefits compared with PBO, which was consistent with the co-primary outcome results in the overall RECONNECT Core Study population.

9. Uterine Fibroid Embolization Education

Britt Dana Wilmoth MSN, APRN, FNP-BC 1 Cornwell Jennifer MSN, APRN, FNP-BC 2

1,2 VCU Health

Background: As an integral part of a successful Uterine Fibroid Embolization (UFE) program, our purpose and focus is to provide quality medical knowledge to staff and health care professionals as well as educating patients and the community on all possible treatment options. These educational opportunities allow patients to choose the best treatment plan for their individual situations. With the use of Interventional Radiology procedures, we are able to provide a less invasive “Without the Scalpel” option for patients.

Methods: Provide in-services within our medical center as well as community settings. Developed and implemented an informational website to provide educational materials to enhance professional relationships among community health care providers, educate patients on new and improved technology that decreases recovery and pain/discomfort (radial access, hypogastric block post-procedure), Collaborate with marketing to develop and complete on-going off-site wellness seminars for community.

Results/Conclusions: Uterine fibroids are among the most common benign tumors in childbearing women. Education of health care professionals, staff, patients and the community is a vital element in providing quality decisions among women regarding treatment options. Through our educational opportunities in the last 5 years, we have enhanced professional relationships, communication and community awareness of Uterine Fibroid Embolization. As a result of community collaboration, we are able and will continually work to meet the rapidly changing healthcare needs of our patient population.

10. Networking as a Career Tool for Students - Is There a Gender Difference?

Bader Angelika MD 1 Heidi Siller PhD 2 Gloria Tauber MA, RN-BC, NEA-BC 3 Margarethe Hochleitner MD 4

1 Women's Health Centre Medical University Innsbruck, 2–4 Gender Medicine Unit Medical University Innsbruck

Background: Networking is known to be an uncontested tool when climbing the career ladder in academe. Men have taken this to heart in old-boy networks, etc. But what about women?

Methods: In the framework of a study of differences between the students at the Medical University of Innsbruck, we surveyed female and male Turkish students in focus groups of 12 persons each, whereby the survey also included one question about networking.

Results: The question “Do you know each other?” was answered in the affirmative by all the men. They stated that they occasionally meet and do things together, such as going to mosque, going out for a drink, etc. Furthermore, they also reported having a buddy system, i.e. they felt an obligation to give first semester students all the information they needed. The women, by contrast, reported that they did not know each other, despite their consisting of student workers at my department and one or two female friends brought by each of them. They engaged in no joint activities whatsoever with persons outside this close circle of friends.

Conclusions: The experience made with these two focus groups corresponded approximately with the cliché of existing male networks and the great need for women to catch up in this respect. However, at the European universities this is largely traced back to the centuries-old tradition of male insider groups, a fact that in our group (almost all holding an Austrian passport) does not provide a satisfactory explanation. Add to this the fact that in recent decades networking has been massively propagated as part of affirmative action programs for women at universities as well as under equality and equal treatment rules. Apparently, these efforts have met with no visible success, a fact that is also true for most of our non-Turkish female students.

11. Menopause Management Knowledge in Post-Graduate Residents: A Cross-Sectional Survey

Kling Juliana M. MD, MPH 1 MacLaughlin Kathy L. MD 2 Schnatz Peter F. DO 3 Crandall Carolyn J. MD 4 Skinner Lisa MD 5 Stuenkel Cynthia A. MD 6 Kaunitz Andrew MD 7 Bitner Diana MD 8 Mara Kristin BS 9 Fohmader Hilsaca Karla S. PhD 10 Faubion Stephanie S. MD 11

1,2,9–11 Mayo Clinic, 3 Reading Hospital, 4,5 University of California, Los Angeles, 6 University of California, San Diego, 7 University of Florida, 8 Michigan State University

Background: The adequacy of residency education on best practices for menopause management is unclear. We aimed to evaluate the knowledge and nature of training for menopause management in post-graduate residents.

Methods: A cross-sectional, anonymous survey was emailed to trainees at all post-graduate levels in family medicine, internal medicine, and obstetrics and gynecology at 20 residency programs across the U.S. The survey evaluated attitudes that may influence menopausal hormone therapy (HT) prescribing, knowledge about HT, availability and type of training on menopause medicine, and demographic information.

Results: 20 U.S. programs participated, providing 183 at least partially completed surveys (703 residents contacted; 26% response rate). Most trainees were between 26–30 years of age (77%), female (66%), and believed it was important or very important to be trained to manage menopause (94%). While a majority of respondents answered some of the menopause competency questions correctly, important gaps were identified. HT was not offered to a symptomatic, newly menopausal woman without contraindications by 34% of participants, and only 39% indicated they would prescribe HT for an adequate duration to a prematurely menopausal woman. Twenty percent reported not receiving any menopause lectures during residency, and only 6.8% reported feeling adequately prepared to manage women going through menopause.

Conclusions: Internal medicine, family medicine, and obstetrics and gynecology residency trainees recognize the importance of training in menopause management, but vital knowledge gaps exist. It is a priority to invest in improving education of future clinicians to provide evidence-based, comprehensive menopause management for the increasing population of midlife women.

12. Comparison of Women's Self-Estimated Risk of Breast Cancer to Their Calculated Risk Using the Gail Risk Assessment Tool

Mehta Jaya MD 1 MacLaughlin Kathy MD 2 Millstine Denise MD 3 Faubion Stephanie MD 4 Wallace Mark MD 5 Shah Amit MD 6 Fields Heather MD 7 Ruddy Barbara MD 8 Bryan Michael MD 9 Patel Bhavika MD 10 Buras Matthew MS 11 Kling Juliana MD, MPH 12

1,3,6–12 Mayo Clinic Arizona, 2,4 Mayo Clinic Minnesota, 5 Mayo Clinc Arizona

Background: Recent changes to breast cancer screening recommendations do not apply to women at high risk of breast cancer. To appropriately apply the guidelines, it is important to accurately estimate women's risk of breast cancer. We compared women's estimates of their breast cancer risk to their risk calculated by the Gail risk score.

Methods: Women presenting to Mayo Clinic in AZ and MN in July 2016 completed a written survey assessing their perceived risk of breast cancer, understanding of breast cancer screening practices, and perceptions of these strategies. Gail risk scores were calculated for all participants. Statistical analysis using the Kruskal-Wallis Test compared Gail risk scores to collected variables.

Results: 614 predominantly white, married and educated ( = college) women completed surveys. Using Gail 5-year risk scores, 53% were low to normal risk (<1.66%), 44% were medium to high risk (>1.66% – < 5%), and 3% were high risk (>5%). Self-estimated risks showed a positive association with higher Gail Risk scores (p < 0.001). Higher calculated Gail risk scores were associated with a strongly positive attitude toward yearly mammography (p = 0.04), history of serious medical problems (p = 0.02), self-reported prior abnormal mammography (p = 0.01), history of breast biopsy (p < 0.001), and more than one first-degree relative with breast cancer (p < 0.001).

Conclusions: Women with medium to high Gail risk scores appropriately assessed themselves as having a higher risk of breast cancer. While some guidelines have changed for screening mammography in average risk women, it is warranted to have thorough discussions and assess breast cancer risk in women to assure risk appropriate screening.

13. Gender Differences Regarding Resilience, Uncertainty, and Burn Out in Primary Care Providers

Tran Elizabeth MD 1 Jacobs Robin PhD 2

1,2 Baylor College of Medicine

Background: Provider burnout is prevalent and can dramatically affect clinical care, yet little has been investigated regarding modifiable factors associated with burnout, such as resilience and clinical uncertainty. This study investigated the intersection of resilience, tolerance to uncertainty in medicine and burnout among primary care physicians (PCPs).

Methods: Using a cross-sectional, correlation design, an online survey was used to collect data from a sample of resident alumni and practitioners in primary care clinics. Questions addressed psychosocial variables (physicians' reactions to uncertainty, individual resilience), behaviors (physician strategies of resilience), and demographic characteristics that might be associated with provider burnout. Chi-square and correlational analyses were analyzed using SPSS.

Results: Eighteen (51.4%) of the sample (N = 46) were women. The mean age was 42.1 (range 29–66 years). The majority worked mainly in outpatient family medicine and reported less than 10 years out of training. Using a 5-point Likert-type scale, the mean score for burnout was 2.37 (SD = 0.770). Women experienced more burnout than men, χ² = 0.025, p < 0.05. Older age was associated with higher resilience (p = 0.049) while higher levels of resilience were associated with lower levels of uncertainty (p = 0.047). Provider uncertainty was correlated with age (p = 0.032) and years since training (p = 0.018).

Conclusions: Physician burnout in the current study was considerably high but higher for women, a finding aligning with previous studies of burnout in women physicians. Younger-aged physicians with fewer years in practice reported higher levels of uncertainty while older-aged counterparts appeared more resilient. As more research is done to explore factors in or predictors of resilience in clinical burnout, efforts to address gender differences may be critical in mitigating the effects of burnout in women PCPs and increase their quality of work life.

14. Silent Walking the Survival Tightrope: Exploring the Fears of Recurrence Among Taiwanese Breast Cancer Survivors

Shu Bih-Ching DrPH 1 Lai Wei-Shu MD, PhD, FACS 2

1,2 National Cheng Kung University

Background: Fear of cancer recurrence (FCR) is the most commonly reported problems and unmet need among breast cancer survivors. However, there are still less studies to in depth explore the specific experiences of FCR among female survivors with breast cancers. Purpose: The aim of this qualitative study was to explore the experiences of recurrence fears among Taiwanese breast cancer survivors.

Methods: We used focus group to collect data. The participants qualified to attend this study were 1). female with breast cancer, 2). who underwent a mastectomy and competed treatments within 2 year, and 3) without another cancer. If these eligible participants were interested to attend this study, they would be informed consent. After IRB approved, the focus group were conducted. In final, three focus groups were conducted. The members of each group were 4–6. The members of the third group were from the group 1 and group 2 who were interested to share their experience more and the diversity and consent of group discussion were reached. Data was analyzed and interpreted using content analysis.

Results: There were 11 women with breast cancer to attend this study. The age of between 41–60 years old. Three themes were extracted from the transcripts to reflect the experiences of fear of cancer recurrence (FCR). They were “Trapped in Insecurity”, “Suffering in Silence”, and “Stop Overthinking.” Participants lived in a complex situation like silent walking the survival tightrope. The results indicate that an avoidance and unspoken FCR in insecure situation, resulting a silent survival journey. Participants felt insecure and suffering rather than celebrating survival after completion of treatment.

Conclusions: This study provides new insights to understand the experiences of FCR, which reflects specific content of recurrence fears. These difficult thoughts and feelings which may impact their daily life reconstruction should be acknowledged. Key words: breast cancer survivors, Fear of cancer recurrence (FCR), focus group.

15. Racial Equity Considerations in Safe to Sleep Messaging: Learning from the Community

Stiffler Deborah PdD, RN 1 Crane Lisa MSN 2

1 Indiana University, 2 Family Nurse Partnership

Background: Infants in unsafe sleep positions are more likely to die from Sudden Unexpected Infant Death (SUID). Safe to Sleep^® education has led to a dramatic decrease in mortality among white infants, but over 60% of Black families do not follow the Safe to Sleep^® parameters. Objectives for this study: 1. Identify why Black mothers are less likely to follow Safe to Sleep^® parameters than White mothers; 2. Identify a way to frame the Safe to Sleep^® message for Black mothers; 3. Identify if and how much family members play in the decision of infant sleep practices.

Methods: We used focus groups for data collection for this study with three populations groups: Black mothers with infants older than 6 months, black grandmothers, home visit nurses who visit the women twice a month after they have delivered until the child turns two.

Results: We identified three themes: Convenience, Safety, and Culture which were synthesized into one final theme: Motivated by Beliefs. The knowledge and understanding of what should be done were disregarded by Black mothers because of their beliefs and the beliefs of their mothers and grandmothers. Many Black mothers believed that SUID/SIDS occurred randomly. Black mothers did what they believed was best for their infants based on aspects of Convenience, Safety, and Culture.

Conclusions: Bed sharing, prone sleeping, and inappropriate bedding/sleep surfaces, predispose an infant to a significantly higher risk of SUID/SIDS. The mothers felt they got contradictory information. They wanted to see people like them tell about Safe to Sleep^® parameters. This study aimed to identify a different way to frame the Safe to Sleep^® message in a way that would resonate with Black women increasing their use of the safe sleep parameters.

16. Factors Influencing Female Chinese Cancer Patients' Health Information Preferences and Behaviors

Su Zhaohui PhD 1 Xie Bo PhD 2

1,2 The University of Texas at Austin

Background: While there is a large and rising population of female Chinese cancer patients, little is known about the key factors shaping their health information preference and behaviors. Most of our current knowledge on cancer patients' health information preferences and behaviors comes from studies conducted in western countries. Considering female Chinese cancer patients are strikingly different from their western counterparts in terms of genetic makeup, socio-economic profile, lifestyle, and culture and health beliefs, research is needed to fill this knowledge and research gap. Significant benefits could be gained from such research: To 1) help understand the rationales behind female Chinese cancer patients' health information preferences and behaviors, 2) shed light on female Chinese-American and Asian cancer patients' interaction with health information, as they share similar culture and health beliefs to Chinese cancer patients, 3) help health professionals better understand these patients preferred communication styles, and 4) provide insights into how to effectively communicate with these populations for various healthcare stakeholders, such as pharmaceutical companies that aim to develop cancer drugs for female Asian cancer patients. This research aims to answer two key research questions: What are the key factors that influence 1) how female Chinese cancer patients formulate their questions about health and cancer and 2) how female Chinese cancer patients answer their health-related questions?

Methods: Considering the lack of research on Chinese cancer patients, a grounded theory guided in-depth interview was conducted to answer the research questions. The data collection and analysis process were carried out with the guidance of the constant comparison method. A total of seven Chinese cancer women was interviewed.

Results: The Harmony Maintenance Model was developed to answer the research questions. The Harmony Maintenance Model suggests that the way female Chinese cancer patients seek harmony from balancing family role, sick role, work role, cultural and health beliefs influence the way they interact with health information. Four major themes emerged from the data analysis: family role, sick role, work role, cultural and health beliefs. How female Chinese cancer patients seek harmony by finding equilibrium from juggling these roles and beliefs influence the way they ask or avoid questions about their health, seek or share health information they know with their social contacts, negotiate with the barriers they encountered while interacting with various sources of information. It is important to note that findings of this study suggest that culture and health beliefs, such as respect for harmony, Yin-Yang beliefs, and reliance on traditional Chinese medicine, play a critical role in shaping female Chinese cancer patients' negotiation of family role, sick role, and work role while they make sense with their health and cancer. An important barrier mentioned by the participants is their doctors' lack of knowledge and respect for traditional Chinese medicine, which often prompt their withholding of questions related to traditional Chinese medicine.

Conclusions: This is one of the first studies that investigated factors that shape female Chinese cancer patients' health information preferences and behaviors. A theoretical model, the Harmony Maintenance Model was developed to answer the research questions. The Harmony Maintenance Model contends that family role, sick role, work role, cultural and health beliefs are the most notable factors influencing female Chinese cancer patients' health information preferences and behaviors. While harmony maintenance is integral to female Chinese cancer patients' interaction with health information, it is important to note that the desire to maintain harmony may hamper the effectiveness of patient-provider communication, as patients are often reluctant to share some of their concerns if they think their doctors may consider them as “difficult questions”. Furthermore, patients often find their doctors' knowledge on traditional Chinese medicine lacking, and their attitudes nonchalant, if not downright disapproving. Considering the important role of cultural and health beliefs in female Chinese patients' interaction with health information, it is important for health professionals to acknowledge these patients' communication preferences and integrate measures to satisfy their health information needs and wants. How to best ensure cancer patients' satisfaction with patient-provider communication is worthy of additional research efforts, as how well patients interact with health information directly associates with their health outcomes, doctors' workload, and pressure on the medical system.

17. Timing and Involvement of Gynecologic Oncologists in Ovarian Cancer Care and Survival

Rim Sun Hee PhD 1 Stewart Sherri L. PhD 2 Thompson Trevor D. BS 3

1–3 Centers for Disease Control and Prevention

Background: To identify patient- and healthcare system- level factors predictive of the extent of gynecologic oncologists' (GO's) involvement in ovarian cancer care and subsequently examine the impact of the timing of GO involvement on overall survival.

Methods: We analyzed detailed treatment information from 2,162 ovarian cancer patients identified through state cancer registries and diagnosed and treated in Georgia and South Carolina between 2004 and 2014. We examined the effect of GO involvement at all treatment phases (e.g. before, during, and after surgical intent-to-cure) using multivariate logistic regression. We also determined the effect of patient- and healthcare systems-level factors on mortality outcomes using Kaplan-Meir survival curves and Cox proportional hazards models.

Results: A GO was involved in the care of 79.7% of ovarian cancer patients. Women aged 70 years and older had statistically significantly lower odds (OR = 0.48, 95% CI, 0.27-0.83) of ever having a GO involved compared to women aged 49 years or younger. Receiving care at a National Cancer Institute (NCI)-designated cancer center was associated with greater odds of GO involvement in all patient cases, regardless of race or ethnicity and longer median survival time (1828 vs 897 days, log-rank p < 0.001) compared to those not seen at an NCI cancer center. Among white patients only, those seen at NCI-designated cancer centers had greater odds (OR = 3.65, 95% CI, 1.46–9.15) of intra/post-operative care from a GO compared to those not seen at an NCI facility. After adjustment of covariates, white women had significantly better survival outcomes (lower risk of death [hazard ratio = 0.63 (95%CI: 0.41–0.96, p = 0.03)] when seen at NCI-designated cancer center than women of other races.

Conclusions: While GO involvement does improve median survival, differences are apparent by patient race and place of care. This likely reflects heterogeneity of clinical management, the process of patient care in large cancer centers, as well as the complexity of provider and patient-level factors and patient preferences in determining the extent of care. These differences may contribute to the differences in ovarian cancer survival observed among different races.

18. Breast and Cervical Cancer Screening Prevalence Among Eligible Women with Different BMI

Charkhchi Paniz MD 1 Carlos Ruth MD 2

1,2 University of Michigan

Background: Our purposes were 1) to estimate the prevalence of the breast and cervical cancer screening among different BMI, 2) to assess the independent effect of BMI on screening adherence adjusting with social determinates of health, sexual orientation, gender identity and sociodemographic.

Methods: We used the 2016 Behavioral Risk Factor Surveillance System data. We defined breast cancer screening adherence as individuals with ages 40–74 who had mammography in the past two years. Cervical cancer screening adherence defined as women age 21 to 65 years with pap smear every 3 years or women age 30 to 65 years with a combination of cytology and HPV testing every 5 years. We assessed the screening prevalence and performed prevalence ratio and logistic regression.

Results: Breast screening: Proportion of screening was 73.83% (95% CI = 73.34–74.30). Proportion of screening among different BMI were as following: BMI <18.5; 62.92% (95% CI = 58.67–67.17), BMI 18.5–25; 73.10% (95% CI = 72.21–73.98), BMI 25–30; 75.70% (95% CI = 74.82–76.56) and BMI >30; 73.56% (95%CI = 72.70–74.42). Compared to normal BMI, prevalence of screening among BMI <18.5 was 0.86 (95% CI = 0.80–0.92) times lower and among BMI 25–30 was 1.03 (95% CI = 1.01–1.05) higher. Prevalence of screening in bisexuals was 0.80 (95% CI = 0.71–.90) times lower compared to heterosexuals. In regression models BMI <18.5 decreased the likelihood of getting screened (OR = 0.54; 95% CI = 0.36–0.83) in addition to being bisexual, having health access hardship, living in rural area. Having BMI 25–30 increased the likelihood of screening (OR = 1.24; 95% CI = 1.09–1.41).

Cervical screening: Proportion of screening was 81.99% (95% CI = 81.53–82.45). Proportion of screening among different BMI were as following: BMI <18.5; 68.24% (95% CI = 63.31–73.17), BMI 18.5–25; 82.12% (95% CI = 81.39–82.84), BMI 25–30; 83.71% (95% CI = 82.83–84.58) and BMI >30; 81.96% (95% CI = 81.11–82.79). Compared to normal weight, underweight are getting screened 0.69 (95%CI = 0.56–0.86) times lower, and overweight had 1.02 (95%CI = 1.01–1.03) times higher rates. Homosexuals (0.84, 95%CI = 0.75–0.94) and bisexuals (0.87, 95% CI = 0.82–0.92) are getting lower rates of screening than heterosexuals. Transgenders were getting screened 0.72 (95% CI = 0.54–0.97) times lesser than cisgender.

Conclusions: We demonstrated a significant lower rate of screening adherence among underweight individuals comparing with other BMI across both screening types. Across both screening types, overweight individuals had a significant higher rates of screening compared to normal weights. We found that being underweight independently decreased likelihood of screening adherence in both screening. While being overweight independently increased the likelihood of breast cancer screening adherence. We found that bisexual women had independently decreased likelihood of breast cancer screening adherence.

19. A Process Evaluation on Exploring the Modular Task-Sharing Intervention of Frontline Social Health Activists ‘Sahiya’ for Improving Women's Health Through Family Planning Counselling Services in Jharkhand, India

Sahu Monalisha MD 1 Lalchandani Kamlesh MD 2 Singh Dhananjay MBBS 3

1–3 JHPIEGO

Background: For improving health status of women, quality family planning counselling services is a globally known standard approach. In depth gap analysis of the facilities across the state of Jharkhand in India indicated unavailability of FP counsellors in most of the facilities. ‘Sahhiyas the frontline health social health activists were informally engaged in orienting clients on FP services. Exploring the opportunity, State Working Group advocated and piloted an innovative approach of task-sharing of ‘Sahhiyas’ as ‘FP Communicators’.

Methods: Objectives of study was to describe the process evaluation in five pilot districts to assess feasibility and sustainability of the intervention from November 2016 to November 2017. Sahhiya training module was developed on ‘Balanced Counselling Strategy (BCS). Purposive sampling was used to select Sahhiyas with good communication skills residing in the vicinity of public health facilities. Process evaluation data covering the resource utilization associated with all intervention collected, and analyzed under-1) Development of customized BCS tool kit, job aids; 2) Capacity building of Sahhiyas- in phase-based cascade manner 3) Availability of FP Communicators at health facilities.

Results: With the technical assistance of JHPIEGO India team BCS tool kits were customized, field-tested and validated by August 2017. In coordination with Block Training Team 629 Sahhiyas were trained by October 2017. Sahhiyas filled in as FP communicator at 42 facilities in 5 districts of Ranchi, Bokaro, Giridih, Ramgarh, Dhanbad in Jharkhand by November 2017. Preliminary data showed increased uptake and better method-mix for contraceptives despite initial challenges of roster regularization. Role of Block Program managers and Block Training Teams was imperative for supportive -supervision and reorientation.

Conclusions: Task-sharing by Sahhiyas for FP Communication is an effective and acceptable strategy; can be scaled up to the entire state for overall improvement of Women's health. Incentivization of intervention may result in improved internalization and sustainability.

Keywords: Sahhiya, Family Planning Communication, Balanced counselling strategy, Process Evaluation

20. Substance Use Among Pregnant Women with Disabilities

Kitsantas Panagiota PhD 1 Ramos Yesenia MS 2

1 George Mason University, 2 National Institutes of Health

Background: Child bearing among women with intellectual or developmental disabilities (IDD) has been increasing in the past few years. However, limited research has been conducted on substance use during pregnancy among women with IDD. The purpose of this study was to examine substance use such as alcohol consumption, tobacco and marijuana use among pregnant women with disabilities.

Methods: Data from the 2016 National Survey of Substance and Drug Abuse was used and included a sample size of 707 pregnant women. Disabilities in women were measured based on the World Health Organization Disability Assessment Schedule which measures functional impairment such as disturbances in social adjustment and behavior (i.e., functional impairment). Descriptive statistics and logistic regression analyses were performed.

Results: Approximately 30% of the women experienced some form of functional impairment while pregnant. Findings show that pregnant women with moderate/severe functional impairment were more likely to have consumed alcohol (OR = 1.77, 95% CI: 1.03, 3.03), smoke cigarettes (OR = 1.80, 95%CI: 1.15, 2.81) and use marijuana (OR = 2.49, 95% CI: 1.38, 4.47) in the past month than their counterparts with no such impairments.

Conclusions: A large number of women experience disabilities during pregnancy. Given their higher risk of engaging in alcohol, tobacco and illicit drugs, health care providers need to pay attention to the needs of this population in order to ensure appropriate and sufficient perinatal care.

21. Investigating the Relationship Between Mental Health Status, Hypertension, and Hospital Inpatient Visits in Women in the U.S.

Rozario Sylvia MPH 1 Masho Saba DrPH 2

1,2 Virginia Commonwealth University

Background: Poor mental health status is more prevalent in women and may be related to poor hypertension outcomes and increased hospital inpatient visits. This study aims to find the association between mental health status and hypertension in women and the combined effect of mental health status and hypertension on hospital inpatient visits in women in the U.S.

Methods: The household component (HC) of 2014 Medical Expenditure Panel Surveys (MEPS) was analyzed (n = 10,946). Kessler (K6) scale for mental health status (poor, good/excellent), hypertension (yes, no), and hospital inpatient visits (yes, no) were examined. A combined effect variable for mental health status and hypertension was created. Multiple logistic regression analysis was conducted and adjusted odds ratios with corresponding 95% confidence intervals were calculated.

Results: After adjusting for confounders, women who reported poor mental health had significantly higher odds of hypertension compared to women who reported good/excellent mental health (AOR = 1.39, 95% CI = 1.16, 1.68). Further, women who reported hypertension coupled with poor mental health had higher odds of having hospital inpatient visits compared to women who reported no hypertension coupled with good/excellent mental health in the adjusted analysis (AOR = 3.03, 95% CI = 1.96, 4.69).

Conclusions: There is a significant association between mental health status and hypertension in women. Further, poor mental health status coupled with hypertension leads to increase hospital inpatient visits for women. It is important that health professionals focus on utilizing available screening tools to assess mental health status of women for early detection and to manage the disorder.

22. Evaluation of Women's Participation in Clinical Trials Worldwide: An FDA Perspective

Ayuso Emily MS 1 Geller Ruth MS 2 Wang Junyang MS 3 Whyte John MD, MPH 4 Jenkins Marjorie MD, FACP 5

1–5 US Food and Drug Administration

Background: The US Food and Drug Administration (FDA) has undertaken a multitude of efforts to promote representation of women in clinical trials including regulation and guidance. The objective of this research is to assess women's participation in clinical trials from a global perspective and analyze the demographic characteristics.

Methods: FDA's Center for Drug Evaluation and Research-Professional Affairs and Stakeholder Engagement (CDER/PASE) and the Office of Women's Health (OWH) collaborated to evaluate the demographic data (race, ethnicity, gender, and age) of pivotal trials of New Molecular Entities (NMEs) approved in 2015-2016 by geographic location. 154 pivotal clinical trials supporting 66 NMEs were identified, and the research team analyzed the demographic characteristics of 131,749 participants from 70 countries.

Results: Although the U.S. sites contributed 31% of the 131,749 study participants, the majority (69%) of the participants were from non-U.S. sites. On the country level, the United States contributed the largest number of participants and other individual countries contributed 5% or less of the total trial population. Globally, in terms of participation by gender, 43% (n = 56,272) of the 131,747 clinical trial participants were women. Forty-nine percent of the 40,833 U.S. participants were women as compared to 40% of the 90,914 non-U.S. participants. Similar levels of participation were seen after the exclusion of sex-specific drug indications, and Similar levels of participation were seen by therapeutic area for the U.S. and non-U.S. sites.

Conclusions: Published literature suggests that the growth of global clinical trials could be due to multiple environmental factors. FDA approval processes ensures that global data utilized in the drug approval process meets regulatory standards and that the data can be generalized to the US population.

23. Gender Differences in Cancer Patients' Health Information Behaviors: A Systematic Review of Literature

Su Zhaohui MA, PhD Fellow Postdoctoral 1 Li Xiaoshan MS Candidate Doctoral 2

1 School of Nursing, The University of Texas at Austin, 2 Stan Richards School of Advertising, The University of Texas at Austin

Background: There are substantial differences in the ways female and male cancer patients relate to health, due to factors such as pathological characteristics (e.g., survival rates), social norms (e.g., gender roles), and individual lifestyles (e.g., smoking habits). While healthcare professionals' clear and comprehensive understanding of cancer patients' gender differences in information preferences and practices could facilitate effective patient-provider communication, little is known about how female and male cancer patients' interaction with health information differs.

Objective: To investigate gender differences in female and male cancer patients' health information preferences and practices.

Methods: A systematic review of empirical literature was carried out in October 2017. Four rounds of screening of records resulted in a final pool of 25 articles.

Results: Female cancer patients have a greater need for health information than male patients. Compared to their male counterparts, female cancer patients are more active in information seeking: they are more likely to voice their questions and concerns, rely on more sources of information, and seek more kinds of information. As to information avoidance, females are more likely to admit if they avoid information than male cancer patients. Furthermore, female patients are more likely to share information, particularly with their intimate social contacts, compared to their male counterparts. Overall, male cancer patients are less likely to disclose their questions and concerns, usually due to stigma-related reasons. With regard to information accepting, both female and male cancer patients consider trust and quality of the information as important deciding factors.

Conclusions: Our results highlight the distinctive differences in the ways female and male cancer patients interact with health information. Findings of this study suggest that healthcare professionals should adjust their communication styles based on patients' characteristics, such as gender, to facilitate effectiveness patient-provider communication, and in turn, optimize patients' health outcomes and quality of life.

24. Prenatal Marijuana and Nicotine Use: Detection and Related Psychosocial Variables

Sadicario Jaclyn BA 1 Kelpin Sydney MS 2 Karjane Nicole MD 3 Svikis Dace PhD 4

1,2,4 Virginia Commonwealth University, 3 VCUHealth

Background: Prenatal marijuana (MJ) and nicotine (NIC) use is prevalent and has been associated with impaired fetal growth and neurobehavioral deficits (Fried, 2002). Screening provides an opportunity for patient education and intervention. The present study examines methods of detecting prenatal MJ and NIC use and examines psychosocial/mental health correlates of use in an at-risk sample of pregnant women.

Methods: The sample included pregnant women (N = 254) at risk for prenatal substance use enrolled in a clinical trial focused on HIV/STD prevention. Participants completed the ASI and provided a urine sample to assay for THC. Analyses included chi-squares and t-tests.

Results: The sample was 75.6% African American with a mean age of 26 yrs. One-third (32%) screened positive for recent MJ use. Approximately 42% screened positive for recent nicotine use by self report alone. When MJ+ and MJ− women were compared, MJ+ women were more likely to report recent anxiety (54% vs 39%; p < .031); lifetime depression (86.8% and 74.2%; p < .03) and recent thoughts of suicide (7.4% and 1.6%, p < .02). They were also more likely than MJ− women to report recent emotional abuse (39.7% and 22.6%; p < .007) and recent physical abuse (13.2% vs 3.2%; p < .003). MJ+ women reported on average, more days using nicotine in the past month than MJ− women (t(226) = −3.37, p < .001). NIC+ women reported having more recent emotional problems than NIC− women (t(226) = −3.09, p < .002).

Conclusions: MJ+ and NIC+ pregnant women present for care with a variety of comorbid concerns. Changing legal and social policies on MJ use affirm the need for further research to better understand associations between these risk factors and adverse maternal and infant outcomes.

25. Baseline Mammogram: Cross-Sectional Survey of Women Undergoing Screening Mammography Demonstrates Need for Educating Patients About the Importance of a Baseline Mammogram as Comparison for Radiologists

Horsley Robert MD 1 Kling Juliana MD, MPH 2 Vegunta Suneela MD 3 Lorans Roxanne MD 4 Temkit H'hamed PhD 5 Patel Bhavika MD 6

1–6 Mayo Clinic

Background: Studies have shown that having a baseline mammogram, the first screening mammogram, as comparison available at the time of reading a mammogram, significantly decreases the potential of a false-positive examination. Our aim was to evaluate womens' knowledge and perception about the significance of baseline mammograms.

Methods: A cross-sectional prospective survey study was conducted in women without a history of breast cancer presenting for their screening mammogram at the Mayo Clinic, Arizona. Respondents were surveyed anonymously between March and April 2017. The questionnaire was developed based on provider input and pretested for readability and clarity.

Results: 401 women (87% white, 93% educated beyond high school) completed surveys. 76.8% women reported having yearly mammograms and 30.9% reported having a history of an abnormal mammogram. 45% had not heard the term baseline mammogram. Of those who had, the most commonly reported source was their primary care provider (31%). Although 73.7% chose the correct definition of a baseline mammogram, 66.8% did not think that a baseline mammogram was important for decreasing associated cost, time and discomfort due to the number of mammograms incorrectly read as abnormal.

Conclusions: In a group of educated women who routinely get mammograms, almost half had not heard the term ‘baseline mammogram’. Furthermore, most women did not think baseline mammography was important for decreasing associated cost, time and discomfort due to mammograms incorrectly being read as abnormal. This study suggests that education efforts to improve women's understanding of baseline mammograms and their importance is warranted.

26. Menopause Symptoms in Underserved and Homeless Women Living in the Extreme Temperatures of Arizona

Mukarram Mahnoor BS 1 Hondula David PhD 2 Buras Matthew MS 3 Kling Juliana MD, MPH 4

1 Barrett, the Honors College at Arizona State University, 2 School of Geographical Sciences and Urban Planning, Arizona State University, 3 Division of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona, 4 Division of Women's Health Internal Medicine, Mayo Clinic, Scottsdale, Arizona

Background: Regional and geographical differences may explain variability in menopausal symptom occurrence possibly due to development of climate-specific thermoneutral zones and population-specific hot flash frequencies. Limited information is available regarding menopausal symptoms in underserved women living in extreme heat. Objectives were to to understand the perception of menopausal symptoms in underserved women living in regions of extreme heat to identify if heat impacts perception of menopausal symptoms.

Methods: Women in free, low-income, and homeless clinics in Phoenix were surveyed during summer and winter months using a self-administered, written questionnaire including demographic, climate and menopause related questions, including the Green Climacteric Scale (GCS).

Results: A total of 139 predominantly Hispanic (56%), uninsured (53%), menopausal (56%), mid-aged (mean 50, SD 9.5) women were surveyed—36% were homeless or in shelters. Most women were not on menopausal hormone therapy (98%). Twenty-two percent reported hot flashes and 26% night sweats. Twenty-five percent of women reported previously becoming ill from heat. More women thought season influenced menopausal symptoms during summer than winter (41% vs. 14%, p = 0.0009). However, a majority of women did not think temperature outside influenced their menopausal symptoms and that did not differ by season (73% in winter vs. 60% in summer, p = 0.1094). No statistically significant differences were seen for reported vasomotor symptoms between winter and summer.

Conclusions: During summer, underserved and homeless women in Arizona were more likely to report that the season influenced their menopausal symptoms than in winter. Regardless of season, low reported vasomotor symptoms were demonstrated.

27. FDA Office of Women's Health Research Impact and Outcomes Framework: Guide to Developing an Organizational Impact and Outcomes Measurement Tool for Program Assessment and Reporting

Robinson Sara MS, MLIS 1 Shafei Dania MS 2 Jenkins Marjorie MD, MEdHP 3

1–3 U.S. Food and Drug Administration

Background: Although there is an immense amount of research across academia, government, and non-government organizations there is a limited amount of information on models to measure research outcomes and impact. FDA Office of Women's Health (OWH) led the development of a diverse intra-agency committee, the Research Impact and Outcomes Subcommittee (RIOSc). The RIOSc work resulted in a Research Impact and Outcomes (RIO) Framework, which allows for tangible and measurable identification of research outcomes and impact. The model is unique in that it is adaptable across programs, such as education, research, and outreach internal and external to FDA.

Methods: The Framework development process began with a review of the literature, focusing on research and other program assessment models. The following steps were identified as key: (1) identify cohort needed for the Framework committee, (2) committee members share their experience and knowledge, (3) identify and define areas of impact in alignment with the organization's core mission areas, (4) define measurable and achievable metrics for each impact area, (5) define the spectrum of effect for each metric across each impact area, and (6) map metrics across the spectrum.

Results: Four impact areas were identified and specifically defined by the Research Impact and Outcomes Subcommittee (RIOSc), reflecting the multifaceted nature of the OWH Mission: (1) Engagement, (2) Advocacy, (3) Significance & Alignment, and (4) Innovation. A total of 40 metrics across the four impact areas were identified. Application of RIO to assess OWH FY18 grant proposals resulted in the transparent selection of proposals that were deemed to have the highest potential for impact within sex differences and women's health.

Conclusions: To our knowledge this is the first adaptable program assessment tool which focuses on sex differences and women's health and is adaptable across research, professional education, and consumer outreach programs.

28. Proposal to Include Art Counseling as Part of Family Planning Counseling: Data to Support this Practice

Khanuja Kavisha BA 1 MacArthur Taleen BA 2 Bachmann Gloria MD 3

1–3 Rutgers Robert Wood Johnson Medical School

Background: With the advent of assisted reproductive technologies (ART), more reproductive options are readily available for women facing infertility. However, ART interventions are associated with potential risks to the mother and to the fetus. Given the inherent risks of ART and the pregnancy that may result from this intervention, we investigated what level of risk women and men report they have had/would be willing to take in order to achieve pregnancy.

Methods: A voluntary, anonymous, HIPPAA compliant online survey using the Qualetrics platform was sent to the Rutgers Robert Wood Johnson Medical School general email listserv, which included faculty, staff, and medical students. IRB approval was obtained prior to administration.

Results: Surveys were sent to approximately 1,000 individuals and 118 unique responses were recorded, giving an 11.8% response rate. Overall, 88.7% of participants reported a desire to achieve a child through pregnancy in the future with 11.3% undecided about having a child in the future. If faced with a life-threatening/previous high-risk fertility or perinatal condition, 95% of respondents reported they would still pursue fertility perseveration options for the potential of a future pregnancy. Further, 71.4% would be willing to pursue ART to achieve a pregnancy despite a high risk of a complicated pregnancy.

Conclusions: These data verify that the desire for individuals to have offspring is extremely strong and confirms widespread acceptance for the use of ART to achieve a pregnancy. These data suggest that ART counseling should be considered as a part of routine family planning encounters.

ART counseling as part of family planning counseling may empower women to better understand their options, and make well-informed decisions not only at that point in their life, but also about how their current decision about family planning may impact their family planning/fertility options in the future.

29. Correlates of Intimate Partner Violence (IPV) in a Primary Care Sample of Women

Kelpin Sydney MS 1 Alvanzo Anika MD, MS 2 Dillon Pamela PharmD 3 Keyser-Marcus Lori PhD 4 Pomm David MS 5 Polak Kathryn MS 6 Parlier Anna Beth BA 7 Svikis Dace PhD 8

1,5–8 Department of Psychology, Virginia Commonwealth University, 2 Division of General Internal Medicine, Johns Hopkins University, 3 Center for Clinical and Translational Research, Virginia Commonwealth University, 4 Department of Psychiatry, Virginia Commonwealth University, 8 Institute for Women's Health, Virginia Commonwealth University

Background: Intimate partner violence (IPV) has been found to be associated with a number of psychological and physical health conditions, suggesting IPV screening may lead to interventions that reduce violence, as well as improve overall health outcomes. Primary care settings have been identified as an ideal setting for such efforts. The present study afforded the unique opportunity to examine anonymous health survey data and identify correlates of IPV in a sample of women presenting to a primary care clinic.

Methods: N = 3,142 women completed an anonymous, computer-delivered health survey. Embedded were two items used to screen for IPV. Women endorsing one or both of these items were compared to those endorsing neither item on a variety of demographics, substance use, and other psychosocial measures using chi-square for categorical and t-tests for continuous variables.

Results: Overall, 12.2% of the sample endorsed IPV. Demographically, the sample was predominantly African American (73%), with a mean age of 45.5 years (SD = 12.53). Women who reported IPV were more likely to be Caucasian (p < .01), younger (p < .001), and divorced (p < .01) compared to those not endorsing IPV. Women who reported IPV were also more likely to report current tobacco use (52% vs. 33%, p < .001), recreational drug use (21% vs. 7%, p < .001), prescription drug misuse (19% vs. 6%, p < .001), screen at risk for both alcohol (T-ACE; 68% vs. 58%, p < .01) and other drug (43% vs. 17%, p < .001) problems, as well as report living with someone with a drug problem (13% vs. 4%, p < .001).

Conclusion: The present study identified a number of correlates of IPV in a primary care sample of women and further supports the importance of implementing routine screening in this population.

30. Improving Birth Outcomes Through Interconception Care at Well Child Visits: The Implicit ICC Model

Wint Kristina MPH 1 Schlar Lisa MD 2 Sullivan Kate MS 3 Brubach Jessica 4

1–4 University of Pittsburgh Medical Center

Background: The IMPLICIT Network, a quality improvement collaborative of health centers, developed a model of ICC (IMPLICIT ICC) which emphasizes screening and interventions during WCVs on four evidence-based risk factors to impact birth outcomes: smoking, depression, family planning, and multivitamin with folic acid use.

Methods: Eighteen primary care centers implemented IMPLICIT ICC and share data with the IMPLICIT Network. IMPLICIT ICC involves repeatedly screening mothers for four behavioral risk factors during the 0–24-month well child visits (WCVs). During the brief assessment, providers reinforce desired behaviors and provide an intervention when needed. This data, in addition to demographics from the accompanying mothers, is collected in the data management system REDCap. Each site has IRB approval for this quality improvement initiative.

Results: From February 2015 until January 2018, there have been 30,179 WCVs with 9,795 unique mom-baby dyads. Women were screened for ICC at 84.6% of visits. 63.5% of screened mothers had medical assistance, 34.6% were black, 19.6% were Hispanic, and 69.9% had a high school education or less. Women reported smoking at 15%, had risk of depression at 7.9%, were not using contraception at 29.0%, and reported not taking a multivitamin at 45% of visits. An appropriate intervention was delivered to women who screened positive for tobacco use at 79.8%, for depression risk at 93.1%, for lack of contraception at 74.3%, and for no multivitamin with folic acid use at 61.2% of visits, respectively.

Conclusion: Screening mothers with IMPLICIT ICC at their child's WCV allows an opportunity to reach women, identify risks, and deliver needed interventions to improve maternal health. Initial outcomes demonstrate that the IMPLICIT ICC model can be implemented in a primary care setting and is an innovative, customizable initiative to improve the health of women who are at highest risk for unintended pregnancy and poor birth outcomes.

31. Risk Factors for Postpartum Depression in African American Women at Risk for Poor Prenatal Care Compliance

Parlier-Ahmad Anna BS 1 Kelpin Sydney MS 2 Masho Saba MD, MPH 3 Keyser Lori PhD 4 Svikis Dace PhD 5

1–5 Virginia Commonwealth University

Background: Postpartum depression (PDD) is fairly common, affecting up to 1in 5 mothers within the first year after giving birth. PPD can lead to negative effects on the mother and baby, including mothers' reduced enjoyment in motherhood responsibilities, reduced ability to recognize and respond to infant cues, and poor mother-infant attachment and relationships. Biological, social, and environmental factors interact and contribute to development of PPD. Some risk factors for PPD include young age, lower education, lower income, obstetric and infant complications, maternal stress, lack of social support, intimate partner violence, and smoking. Studies exploring race and ethnicity as risk factors have mixed results. Some suggest African American women have a lower risk of developing PPD symptoms, while others indicate an increased risk. Objective: The present study is a secondary analysis of clinical trial data examining risk factors for PPD symptoms in African American pregnant women.

Methods: Participants were N = 116 African American pregnant women who consented to a clinical trial of patient navigation and behavioral incentives to improve prenatal care attendance. Inclusion criteria were African American and screen at-risk for low prenatal care attendance. The baseline assessment included medical history, substance use, and psychosocial variables. Postpartum variables included infant birth outcomes and maternal PPD symptoms. A hierarchical linear regression was conducted to examine predictors of PPD symptoms. Measures included: depression history, gestational age at delivery, neonatal intensive care unit (NICU) admission, recent (past 3 months) substance use for mother and father of the baby (FOB), maternal stress, self-esteem, and social support.

Results: Participants had a median age of 24 years (range 16–44). The majority of mothers (92.2%) and FOBs (85.5%) reported recent substance use. Many women reported current or past depression (40.3%). Most women had completed high school or a GED (45.7%), were unemployed (62.1%), had Medicaid (58.6%), and an annual income less than $10,000 (74.1%). The median gestational age at delivery was 39 weeks (range 24–42), and 13.8% of infants were admitted to the NICU. In the hierarchical linear regression, the initial block predicted PPD symptoms, F(3, 89) = 3.35, p = .023, R² = .101. When maternal substance use, FOB substance use, maternal stress, self-esteem, and social support were added the prediction significantly improved, ΔR² = .130, ΔF(5, 84) = 2.85, p = .020. The final model significantly predicted PPD symptoms, F(8, 84) = 3.17, p = .003, R² = .232, and accounted for 23.2% of variance.

Conclusions: The present study sought to identify risk factors for PPD symptoms in an at-risk sample of African American pregnant women. The overall model was significant and accounted for 23.2% of variance. Notably, this sample was already at-risk for adverse outcomes. Identification of PPD risk factors among this population may help facilitate development of tailored interventions. This research was supported by a grant from the Centers for Disease Control (CDC REACH 5U58DP000983) awarded to D. Svikis.

32. Large-Scale Analysis of UCSF Electronic Medical Record to Improve Women's Health in Breast Cancer and Cardiovascular Diseases

Panahiazar Maryam PhD 1 Hadley Dexter MD, PhD 2

1,2 UCSF's Institute for Computational Health Sciences, School of Medicine, University of California, San Francisco

Background: According to National Institute of Health, some health issues that are common to men and women affect women differently. Although the symptoms may be similar, the effects of and the care necessary can differ significantly for women. For example, almost 12% of women in the United States are at risk of developing breast cancer during their lifetime versus less than 1% for men. Women are more likely to die following a heart attack than men are. The objective of this study is to analyze UCSF Electronic Medical Records (EMR) to find the common risk factors for Breast Cancer and Cardiovascular disease. This will help to prevent the patients with similar conditions form the side effects of treatments and predict the possible issues in similar patients. As the outcome of this research, we hope to improve Women's Health. Women, who are the key to maintaining healthy families, on behalf of their children and infants.

Methods: The study cohort includes 525,381 females EMR from 960,129 total at UCSF as of January 2018. Based on Statistical Analysis, Text/Data Mining (e.g. classifiers and rule mining algorithms), we classified patients in a different level of conditions such as cardiovascular problems, hypertension, Stress, etc. Patients with both breast cancer and cardiovascular problems are suffering from some common conditions.

Results: From a total of 525,381 female patients, 69,574 of the patient have diagnosed with hypertension as a most common condition. 29,636 are diagnosed with Breast issues, 25,104 are diagnosed with the heart problem. Most of these patients have common conditions such as hypertension, obesity, low physical activity, poor nutrition, and diabetes.

Conclusions: We introduced the value of improving Women's Health and the distribution of female patient data at UCSF. This study opens the doors to the valuable large-scale analysis of USCF EMR to improve women's health.

33. Building Capacity in CHW and Home Visitors to Promote Reproductive Life Planning

Idehen Alma MEd Albert Eiinstein College of Medicine

Background: Unintended pregnancy is a major concern and a key driver of adverse birth outcomes, racial and ethnic disparities, and poor quality of life in Bronx women of reproductive age. Black women are less likely to begin prenatal care in the first trimester and to receive adequate care. Black women were seven times as likely to die in pregnancy as white women. Hispanic and Asian women were twice as likely to die as white women. The death rate was highest in the Bronx and Brooklyn, which have large poor and minority populations…” A review of NYC maternal death records found black women's lower access to care and lower quality of care are contributing factors. Improving postpartum contraceptive use is an important programmatic strategy to improve the health and well-being of women, newborns, and children. Engaging with access to comprehensive services that promote interconceptional care and appropriate birth spacing and birth control counseling can reduce the risk for poor birth outcomes such as preterm birth and low birth weight. Providing training for clinicians, Community Health Workers and other Home Visitors to build capacity to influence the behaviors attitudes and values of the targeted group to adhere to using birth control and optimize birth spacing will reduce the rates of infant and maternal morbidity and mortality in the targeted Bronx populations and neighborhoods.

Methods: It is our intention to provide multi-level training for clinical staffs and Community Health Workers in the Healthy Start program and clinics as well as engage families in Birth Control Communication strategies to contribute to the improved birth spacing and birth control utilization and reduce birth outcome disparities within the African American community in the Bronx. Trained staffs to deliver consistent messaging and technology support to women of reproductive age and their partners. CHWs will conduct home visits during post-partum period to discuss the importance of birth-spacing practices and postpartum family planning to reduce unintended pregnancy and achieve improved birth spacing to 18-24 months among the target group. The prenatal period is the best time to discuss postpartum contraception; many women feel that these discussions are too brief when held in the hospital after delivery and are crowded by additional postpartum information. Breastfeeding or not, postpartum women have unique contraceptive needs. Although evidence suggests a delay in resumption of ovulation in breastfeeding women, contraception should be addressed before the traditional six-week postpartum office visit to prevent unintended closely spaced pregnancies. We will seek to shorten the interval to 4–5 weeks for the post-partum follow-up visit for Healthy Start and other new mothers. A Multilevel communication strategy will bring together community members in different settings and venues to promote awareness and knowledge of birth spacing, address personal and social barriers to increase the use of contraceptives, including Lactation Amenorrhea Method (LAM).

Results: The readiness of Community Health workers to deliver quality birth spacing/family planning services with confidence. Hospitals and FQHC organizations enhance the quality of their family planning services, birth control services and client centeredness; post-partum visits will be scheduled at 4–5 weeks an participants will attend at least 3 community workshops and may co-lead sessions. All women and men will have high reproductive knowledge and have a written reproductive life plan. Increase adherence to birth spacing of 18–24 months between births. Community capacity to promote well woman care and birth control utilization. This initiative will provide a cadre of trained practitioners to serve the Bronx MICH community providing culturally relevant, linguistically appropriate, skilled women's health services and strengthen family resiliency.

Conclusions: This intervention promotes knowledge and use of contraceptive methods to increase Birth-to-Pregnancy intervals to at least 18–24 months to improve newborn, infant, child, and maternal health outcomes. Reducing the incidence of unintended pregnancy and the adverse outcomes that occur often as a result, and more so in this population, as well as the negative impact on quality of life health and community resilience will be reduced. This intervention will also have a positive impact in reduction of disparities and poverty status. Families will make better decisions and engage in ways that promote economic gains and active participation in their well being. The project will bring together community members in different settings and venues to promote awareness and knowledge of birth spacing, address personal and social barriers to increase the use of contraceptives. The communication strategy is central to the improvement of family planning knowledge and use to ensure spacing pregnancies at least 18–24 months apart and to reduce health risks for both mother and baby.

34. The Role of Insomnia on Depressed Mood in Women at High Risk for Obstructive Sleep Apnea

Morris Jonna L PhD(c), RN 1 Korytkowski Mary MD 2 Sereika Susan PhD 3 Chasens Eileen PhD, RN 4 Atwood Charles W. Jr. MD 5

1,3,4 University of Pittsburgh, 2 University of Pittsburgh Medical Center, 5 VA Pittsburgh Healthcare System

Background: Previous research is unclear in the relation of obstructive sleep apnea (OSA), insomnia and depressed mood in women. This study examined sex differences in the relationship between depressed mood, insomnia and OSA severity in men and women with type 2 diabetes.

Methods: This secondary analysis used baseline data from the ongoing Diabetes Sleep Treatment Trial (R01 DK096028). Sample characteristics included age, sex, education level, race, BMI (kg/m²) and A1C levels. Measures included the Profile of Mood States (POMS) Depression/Dejection subscale; the Insomnia Severity Index (ISI) and AHI (OSA severity), measured by the ApneaLink Pro^®. Higher scores are worse in all measures. The analysis included descriptive statistics, t-tests, and hierarchical linear regression.

Results: The sample (N = 212; 52.0% women, 46.2% African American, middle aged (Mean age ±SD = 56.3 ± 10.4 years), 77.4% > high school) were overweight or obese (Mean BMI ± SD = 34.8 ± 6.9 kg/m²) with suboptimal glucose control (Mean A1C ± SD = 7.8 ± 1.9). Men were older than women (p = .03) with worse AHI (p < .01). There were no significant differences by sex or race in A1C, BMI, depressed mood, or insomnia severity. There was a significant negative correlation of AHI and depressed mood in women (r = −.22, p = .02) but not in men. In the total sample, worse insomnia (p = <.01) but lower AHI (p = .01) was associated with depressed mood. AHI and insomnia were not correlated in the total sample or by sex (p ≥ .05). A linear regression model presented a significant association of sex and depressed mood (b = .28 p = .037); the interaction of sex and insomnia was negatively associated (ΔR2 = .013, b = −.02, p = .078).

Conclusions: Men and women differed in the relationship of impaired sleep and mood. Women had an association between worse depressed mood and insomnia but not with OSA. There were no significant effects of insomnia and OSA severity on depressed mood in men.

35. Lessons Learned from Building an Integrated Care Program for Pregnant Women with Opioid Use Disorders

Polak Kathryn MS 1 Tong Sebastian MD, MPH 2 Aycock Rebecca PhD 3 Abraham Janet MSW 4 Kelpin Sydney MS 5 Svikis Dace PhD 6

1–6 Virginia Commonwealth University

Background: Opioid misuse is a significant public health concern, and is now the leading cause of accidental death. Among pregnant women, the rate of opioid use has been estimated at up to 21%. Maternal opioid misuse is associated with a six-fold increase in obstetric complications, such as low birth weight, toxemia, puerperal morbidity, fetal distress, and meconium aspiration. Additionally, neonatal complications are common and can include Neonatal Abstinence Syndrome, and increased risk of neonatal mortality and sudden infant death syndrome. Objectives: To report on development and implementation of a comprehensive care program at VCU Health for pregnant and post-partum women with Opioid Use Disorders.

Methods: Planning for the clinic began in spring 2016, specialized services (e.g., group therapy) started in summer 2016, and the Starting Anew Clinic was fully implemented in summer 2017.

Results: Development. An interdisciplinary team reviewed literature and models to date for care of the target population. Based on components of Centering Pregnancy (Rising, 1998) and an on-site support group (e.g., Svikis et al., 1998), the team collaboratively created a program that integrated substance abuse treatment and case management with ongoing prenatal care. Starting Anew provides: medication assisted treatment, health education, psychological assessment, psychological treatment, social work interventions, and care coordination. Implementation. This poster presents on the N = 65 pregnant women who have received Starting Anew services. Pregnant women were seen at the clinic for an average of 5.8 medical visits. The mean age was 28.8 (range: 18 to 39) years old. Almost one-third (30.3%) of patients were incarcerated.

Conclusions: The Starting Anew Clinic was developed based on evidence-based practices and literature on care of pregnant women with Substance Use Disorders. Findings to-date confirm that Starting Anew services are being utilized by the target population. Future clinic objectives include implementation of a newly-funded smoking cessation intervention and expanded psychological/psychosocial assessments.

36. Gender Differences in Risk and Protective Factors for Opioid Misuse Among 8th, 10th and 12th Graders

Polak Kathryn MS 1 Dillon Pamela PharmD 2 Koch J. Randy PhD 3 Miller Willis PhD 4 Kelpin Sydney MS 5 Ngjelina Enkelejda MPH 6 Pomm David MS 7 Svikis Dace PhD 8

1–8 Virginia Commonwealth University

Background: The CDC has declared an opioid epidemic, with a quadrupling in opioid-related overdose deaths since 1999 (CDC, 2016). Important gender differences have been found in the development, course and treatment of substance use disorders (SUDs), with females at increased risk for physiological and psychosocial consequences compared to males (Polak et al., 2015). While gender-based vulnerabilities appear to extend to those dependent on opioids (e.g., Back et al., 2011), little is known about the characteristics associated with opioid misuse in male and female adolescents. Objectives: Given the renewed NIH focus on gender/sex as a fundamental variable in research, the present study afforded an opportunity to examine associations between opioid misuse, gender and risk and protective factors in a school-based sample of adolescents.

Methods: Participants were N = 2897 8th, 10th and 12th graders attending a central VA public school system. Students completed a paper-and-pencil survey. Domains included demographics, personal attitudes, substance use, peer influences and family functioning. Looking at lifetime opioid misuse (prescription and/or heroin), chi-square analyses were used to compare risk and protective factors in misusers (n = 293; 8.2%) and non-misusers (n = 3,282; 91.8%). Data were analyzed separately for males and females.

Results: Both male and female opioid misusers were more likely than their non-misusing counterparts to report missing school due to feeling unsafe, having a teacher who doesn't notice/praise hard work, and not having chances to participate in class (all p < .05). However, only female opioid misusers were more likely than female non-misusers to report: academic failure (59% vs 42.5%; p < .001) and thinking “life is not worth it” (53.8% and 31.5%; p < .001). Opioid misusing females were also less likely than the corresponding non-misusers to feel rewarded for prosocial involvement in: school (36.1% vs 52%; p = .003), their community (25% vs 35.5%; p = .011), and with their peers (41.1% vs 53.8%; p = .003). These differences were not found for males.

Conclusions: Female opioid misusers differed from female non-misusers on a greater number of risk and protective variables than the corresponding sample of males. More research is needed as such information may inform identification, prevention and treatment of opioid misuse.

37. Psychosocial Manifestations of Delayed Diagnosis in Women with Turner Syndrome

Reimann Gabrielle BS 1 Comis Leora 2 Perman Martha Bernad 3

1–3 National Institutes of Health

Background: Turner syndrome (TS) is a genetic disorder characterized by partial or complete absence of one X chromosome. Depression is prevalent among the TS population, however studies have yet to examine age at diagnosis as a factor of psychosocial development. This study explored if women who received a late TS diagnosis (at or after age 13) experience worse psychosocial outcomes than those diagnosed early (before age 13), across measures of depression and alcohol and drug use.

Methods: Females with TS (n = 110), ages 22 and older engaged in a cross-sectional study at the National Institutes of Health. Nonparametric analyses, logistic regressions, and tests of association assessed psychosocial differences in early and late diagnosis groups.

Results: In this sample, 47% of participants received a late TS diagnosis. These women exhibited more frequent alcohol and drug use compared to those with early diagnoses (p = 0.007). Among women with late diagnoses, 40% reported depressive symptoms, however less than 20% had clinician-diagnosed depression. Covariate-adjusted models revealed that women with late diagnoses were 7.36 times more likely to develop mild to severe depressive symptoms than those diagnosed early.

Conclusions: These data indicate that delayed TS diagnosis may contribute to adverse psychosocial outcomes related to depression and substance use. Regular mental health screenings are warranted in females with TS, particularly among those diagnosed at age 13 or older. To our knowledge, this is the first study to comment on depression and substance use in relation to age at TS diagnosis.

38. Analysis of Vascular Comorbidities Among Discharges with IUD Removals vs. Insertions Suggests Increased IUD-Related Risk Modified by Race

Azarbaijani Yasameen MS 1 Sier Ashley BS 2 Baydoun Hind PhD 3 Torosyan Yelizaveta MD, PhD 4

1,3,4 Food and Drug Administration, 2 University of Pittsburgh, Graduate School of Public Health

Background: As part of CDRH's efforts for predictive evaluation of real-world performance, we are developing evidentiary approaches aimed at device evaluation in sex/race-stratified subpopulations. The current study explores possible adverse outcomes pertaining to intrauterine devices (IUD), by comparing likelihoods of vascular comorbidities among the race-stratified women subpopulations with IUD insertion vs. IUD removal.

Methods: National Inpatient Sample from Agency for Healthcare Research & Quality (NIS/AHRQ) was used for a retrospective analysis of vascular comorbidities in IUD-related discharges, identified by CCS and ICD9 codes. Using AHRQ/NIS data (2010-2014) and SAS v.9.4, the incidence of vascular comorbidities was compared among discharges with no IUD-related codes (no-IUD controls) and the race-stratified (White, Black, and Rest) discharges with IUD removal or IUD insertion.

Results: When compared to no-IUD controls, Peripheral Vascular and Cardiovascular comorbidities were less frequent among both IUD insertions and removals and Cerebrovascular comorbidities were less frequent only among IUD insertions. A race-stratified analysis among IUD removals vs. insertions showed increased risks for Cardiovascular comorbidities among White women: OR = 1.60 [95%CI:1.01;2.54] and for Cerebrovascular comorbidities among White and Rest women: OR = 2.27 [95%CI:2.24;2.31] and OR = 1.95 [95%CI:1.90;2.00], respectively. The likelihood of Hypertension was increased among IUD removals vs. insertions in all race-stratified subpopulations. Black women with IUD removals had the highest risk of HTN, further confirmed by direct comparison with their White counterparts: OR = 3.67 [95%CI:2.31;5.83].

Conclusions: Thus, IUDs may increase risk of vascular comorbidities and its modification by race suggests the need for race-related biomarkers.

39. Risk of Endometriosis is Greatly Increased in White Women with IUD Removal vs. Insertion

Sier Ashley BS 1 Azarbaijani Yasameen MS 2 Baydoun Hind PhD 3 Torosyan Yelizaveta MD, PhD 4

1 University of Pittsburgh, Graduate School of Public Health; 2–4 Food and Drug Administration

Background: As part of Translational Epidemiology/Genetics research for predictive evaluation of real-world performance of medical devices, we are developing biomarker-based evidentiary approaches for device evaluation in sex/race-stratified subpopulations. The current study examines the role of Endometriosis as possible intrauterine device (IUD) related adverse outcome.

Methods: National Inpatient Sample from Agency for Healthcare Research & Quality (2010-2014) was used for a retrospective analysis of comorbidities in IUD-related discharges, using CCS and ICD9 codes. Using SAS v.9.4, the incidence of Endometriosis was compared among discharges with no IUD codes (no-IUD) and race-stratified (White, Black, and Rest) discharges with IUD removal vs. insertion.

Results: Compared to no-IUD, Overall Endometriosis conditions were less frequent among IUD insertions: OR = 0.38 [95%CI:0.22;0.67], but much more frequent among IUD removals: OR = 8.86 [95%CI:7.13;11.01]. The highly increased risk of Endometriosis/Uterus in IUD removals vs. insertions was limited to White women: OR = 33.52 [95%CI:8.07;139.3]. A direct comparison between White and Black women with IUD removals confirmed a lower risk of Endometriosis/Uterus among Black women: OR = 0.43 [95%CI:0.18;1.03]. The risk of Endometriosis/No Uterus was greatly increased in White and Rest women with IUD removals vs. insertions: OR = 152.2 [95%CI:150.1;154.3] and OR = 19.66 [95%CI:19.17;20.17], respectively. In silico queries identified SNPs that can be considered for further evaluation as putative race-related Endometriosis biomarkers.

Conclusions: Thus, IUDs may exacerbate the known inherent risk of Endometriosis in White women, suggesting the need for biomarkers that can predict and mitigate the race-related Endometriosis risk among IUD users.

40. Healthcare Experiences of Older Adolescent Girls and People Who Can Become Pregnant

Stevenson Micaela BS 1 Moore Megan PhD 2

1,2 Eastern Michigan University

Background: Racial health disparities are prominent in the United States impact various aspects of physical and mental health (National Center For Health Statistics, 2016). While research is lacking regarding general reproductive health experiences for older adolescent girls and people who can become pregnant, there is also limited research regarding racial health disparities in reproductive healthcare in this population. This study will assess the reproductive health experiences of older adolescent women and people who can become pregnant and racial disparities therein.

Methods: Eastern Michigan University's Internal Review Board approved this study (UHSRC-FY17-18-110). 226 women and people who can become pregnant between 18 and 24 from Southeast Michigan were given an anonymous Qualtrics survey, which inquired about healthcare experiences and demographic information. These data were analyzed using linear regression statistics and frequencies within descriptive statistics.

Results: 84% of participants saw physicians at least annually. 71% of participants felt comfortable with their healthcare provider. Over 90% of participants felt their healthcare practitioners were interested in their health. 95% of participants reported that their doctors did not say offensive things to them. When assessing the differences between participants of color and white participants, people of color were less likely to interact with healthcare professionals of the same ethnicity and were less likely to report access to healthcare professionals outside of emergency situations. Additionally, people of color were more likely to be prescribed contraceptives they did not want.

Conclusions: This research provides missing information around reproductive health disparities in women and individuals who could become pregnant. These findings may influence conversations primary care providers have with and types of contraceptives they offer patients. These findings illuminate some racial disparities in reproductive healthcare. However, more research is needed to establish why people of color have decreased access to physicians and how healthcare experiences can be improved.

41. Comparison of Psycho-Social Health in Women With Risky and Without Risk Pregnancies

Ozturk Rusen PhD, RN, FAAN EGE University

Background: It is emphasized that when the medical evaluation is performed in the follow-up of a pregnant woman, psychosocial assessment as well as physical evaluation and evaluation of the risk factors that may be caused is important in terms of a holistic approach. It is very important to determine at what level of psychosocial adaptations of women who have and have not experienced problems in pregnancy and to develop ways of solve by determining the issues that need to be addressed in terms of nursing. In this regard, the main purpose of the study is to compare the psychosocial adaptations related to pregnancy of women who do not carry the risk in pregnancy and pregnancies.

Methods: The study data collected to 253 pregnant women between 15.04.2016-15.04.2017 in two hospitals, one in a state hospital and one in a university hospital, among the risky pregnancies in the obstetrics and gynecology service and healthy pregnancies admitted to polyclinic. In the data collection Demographic Information Form composed of 27 questions and Pregnancy Psychosocial Health Assessment Questionnaire Scale (SAPS) by researchers using the technique of face to face interviews were applied. Women who accepted to participate in the study, who was literacy, risky and no-risky in pregnancy, women without psychiatric disease in pregnancy and second trimester of pregnancies were included in the study. Data were evaluated using the SPSS program, frequency distribution, the chi-square, independent t test.

Results: This study was conducted with 253 pregnant women with an average age of 28.9 ± 6.66. Pregnancy who participated in the study have reported that 40.3% of pregnant women in the first pregnancy, which was 74.3% of the pregnancies wants, 77.5% received support during pregnancy and 36.4% of the received support from their family was found. It was found that 37.2% of the surveyed pregnancies had a risky situation in pregnancy and 13.8% had abort us as a risk. Studies of socio-demographic characteristics of the pregnant women comparison examined; groups and between socio-demographic characteristics (except for the number of controls at the gestation, the previous form of delivery, chronic disease status and gestational support) were found to not be a statistically significant difference (p > 0.05). Of pregnant women with and without risk of Psychosocial Health Assessment Questionnaire total and subscale scores are examined by comparing the mean; between the characteristics of pregnancy and spouse relationship, the characteristics of anxiety and stress, characteristics of belonging to domestic violence, psycho-social support to the requirement characteristics, family characteristics, characteristics sub-dimensions of physical-psychosocial changes and the dimensions of difference between the mean total scores were found to be statistically significant (p < 0.05).

Conclusions: Conclusion: Psycho-social health of pregnancy women who participated in the study was found to be moderate. Pregnancy risk or no risk of being Psychosocial Health Assessment Questionnaire total score affect and the mean total scores of the risk pregnant women were found to be higher than without risk pregnant women.