Faculty Bibliography

BACKGROUND:Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA. METHODS:We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics. DISCUSSION:This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences. TRIAL REGISTRATION:Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.

BACKGROUND:A ring-shaped, contraceptive vaginal system designed to last 1 year (13 cycles) delivers an average of 0·15 mg segesterone acetate and 0·013 mg ethinylestradiol per day. We evaluated the efficacy of this contraceptive vaginal system and return to menses or pregnancy after use. METHODS:In two identically designed, multicentre, open-label, single-arm, phase 3 trials (one at 15 US academic and community sites and one at 12 US and international academic and community sites), participants followed a 21-days-in, 7-days-out segesterone acetate and ethinylestradiol contraceptive vaginal system schedule for up to 13 cycles. Participants were healthy, sexually active, non-pregnant, non-sterilised women aged 18-40 years. Women were cautioned that any removals during the 21 days of cyclic use should not exceed 2 h, and used daily paper diaries to record vaginal system use. Consistent with regulatory requirements for contraceptives, we calculated the Pearl Index for women aged 35 years and younger, excluding adjunctive contraception cycles, as the primary efficacy outcome measure. We also did intention-to-treat Kaplan-Meier life table analyses and followed up women who did not use hormonal contraceptives or desired pregnancy after study completion for 6 months for return to menses or pregnancy. The trials are registered with ClinicalTrials.gov, numbers NCT00455156 and NCT00263341. FINDINGS:Between Dec 19, 2006, and Oct 9, 2009, at the 15 US sites, and between Nov 1, 2006, and July 2, 2009, at the 12 US and international sites we enrolled 2278 women. Our overall efficacy analysis included 2265 participants (1130 in the US study and 1135 in the international study) and 1303 (57·5%) participants completed up to 13 cycles. The Pearl Index for the primary efficacy group was 2·98 (95% CI 2·13-4·06) per 100 woman-years, and was well within the range indicative of efficacy for a contraceptive under a woman's control. The Kaplan-Meier analysis revealed the contraceptive vaginal system was 97·5% effective, which provided further evidence of efficacy. Pregnancy occurrence was similar across cycles. All 290 follow-up participants reported return to menses or became pregnant (24 [63%] of 38 women who desired pregnancy) within 6 months. INTERPRETATION:The segesterone acetate and ethinylestradiol contraceptive vaginal system is an effective contraceptive for 13 consecutive cycles of use. This new product adds to the contraceptive method mix and the 1-year duration of use means that women do not need to return to the clinic or pharmacy for refills every few months. FUNDING:Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, the US Agency for International Development, and the WHO Reproductive Health Research Department.

OBJECTIVES:The objective of this study is to examine the effect of additional cadaver laboratory use in training obstetrics and gynecology (OBGYN) residents on transobturator vaginal tape (TOT) insertion. METHODS:Thirty-four OBGYN residents were randomized into 2 groups (group 1, control; group 2, intervention; 17 in each group). Before and after the interventions, written knowledge and confidence levels were assessed. Both groups received didactic lectures using a bony pelvis and an instructional video on TOT insertion; group 2 participated in a half day cadaver laboratory. Surgical skills were assessed by placing 1 arm of the TOT trocar on a custom-designed pelvic model simulator while being graded by an Female Pelvic Medicine and Reconstructive Surgery (FPMRS) board-certified proctor. RESULTS:Demographics were comparable. Baseline knowledge and confidence level before interventions were similar. After interventions, knowledge scores improved for both groups (8.8% for group 1; 14.1% for group 2); TOT insertion scores were significantly higher in group 2 (6.76/15 ± 2.54 group 1; 10.24/15 ± 2.73 group 2, P < 0.01); confidence scores improved in both groups. The pelvic model simulator was rated as the most useful method to learn TOT placement by group 1. Group 2 rated TOT simulation (47%) and cadaver laboratory (41%). All trainees reported that the pelvic model was highly realistic. CONCLUSIONS:Cadaver laboratory exposure, along with other educational interventions (lectures and video), improves OBGYN residents' confidence, knowledge, and surgical skills regarding TOT placement. The custom-designed pelvic model allows for a realistic simulation of TOT placement: it can be used to assess resident surgical skills and also aid the training of OBGYN residents.

BACKGROUND: Benefits of exposure to global health training during medical education are well documented and residents' demand for this training is increasing. Despite this, it is offered by few US obstetrics and gynaecology (OBGYN) residency training programmes. OBJECTIVES: To evaluate interest, perceived importance, predictors of global health interest and barriers to offering global health training among prospective OBGYN residents, current OBGYN residents and US OGBYN residency directors. METHODS: We designed two questionnaires using Likert scale questions to assess perceived importance of global health training. The first was distributed to current and prospective OBGYN residents interviewing at a US residency programme during 2012-2013. The second questionnaire distributed to US OBGYN programme directors assessed for existing global health programmes and global health training barriers. A composite Global Health Interest/Importance score was tabulated from the Likert scores. Multivariable linear regression was performed to assess for predictors of Global Health Interest/Importance. RESULTS: A total of 159 trainees (77%; 129 prospective OBGYN residents and 30 residents) and 69 (28%) programme directors completed the questionnaires. Median Global Health Interest/Importance score was 7 (IQR 4-9). Prior volunteer experience was predictive of a 5-point increase in Global Health Interest/Importance score (95% CI -0.19 to 9.85; p=0.02). The most commonly cited barriers were cost and time. CONCLUSION: Interest and perceived importance of global health training in US OBGYN residency programmes is evident among trainees and programme directors; however, significant financial and time barriers prevent many programmes from offering opportunities to their trainees. Prior volunteer experience predicts global health interest.

OBJECTIVES/OBJECTIVE:This study was undertaken to evaluate the expression of transforming growth factor β1 (TGF-β1) and matrix metalloproteinase 9 (MMP-9), key regulators of the extracellular matrix composition, in the uterosacral ligaments (USLs) of women with pelvic organ prolapse (POP) compared with controls. METHODS:Under an institutional review board approval, USL samples were obtained from women undergoing vaginal hysterectomy for stage 2 or greater POP (cases, n = 21) and from women without POP undergoing vaginal hysterectomy for benign indications (controls, n = 19). Hematoxylin and eosin and trichrome staining were performed on the USL sections, and the distribution of smooth muscle and fibrous tissue were quantified. Immunohistochemical staining was performed using anti-TGF-β1 and anti-MMP-9 antibodies. The expressions of TGF-β1 and MMP-9 were evaluated by the pathologist, who was blinded to all clinical data. RESULTS:Transforming growth factor β1 expression positively correlated with MMP-9 expression (R = 0.4, P = 0.01). The expressions of TGF-β1 and MMP-9 were similar in subjects with POP versus controls. There was a significant increase in fibrous tissue (P = 0.008) and a corresponding decrease in smooth muscle (P = 0.03), associated with increasing age. The TGF-β1 expression, but not MMP-9 expression, also significantly increased with age (P = 0.02). DISCUSSION/CONCLUSIONS:Although our study uncovered age-related alterations in USL composition and TGF-β1 expression, there was no difference in the expression of TGF-β1 or MMP-9 in the subjects with POP versus controls.