Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies. Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved. Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes. Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.

Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.

OBJECTIVE: To develop an annotation model to apply natural language processing (NLP) to device adverse event reports and implement the model to evaluate the most frequently experienced events among women reporting a sterilization device removal. METHODS: We included adverse event reports from the Manufacturer and User Facility Device Experience database from January 2005 to June 2018 related to device removal following hysteroscopic sterilization. We used an iterative process to develop an annotation model that extracts six categories of desired information and applied the annotation model to train an NLP algorithm. We assessed the model performance using positive predictive value (PPV, also known as precision), sensitivity (also known as recall), and F1 score (a combined measure of PPV and sensitivity). Using extracted variables, we summarized the reporting source, the presence of prespecified and other patient and device events, additional sterilizations and other procedures performed, and time from implantation to removal. RESULTS: The overall F1 score was 91.5% for labeled items and 93.9% for distinct events after excluding duplicates. A total of 16 535 reports of device removal were analyzed. The most frequently reported patient and device events were abdominal/pelvic/genital pain (N = 13 166, 79.6%) and device dislocation/migration (N = 3180, 19.2%), respectively. Of those reporting an additional sterilization procedure, the majority had a hysterectomy or salpingectomy (N = 7932). One-fifth of the cases that had device removal timing specified reported a removal after 7 years following implantation (N = 2444/11 293). CONCLUSIONS: We present a roadmap to develop an annotation model for NLP to analyze device adverse event reports. The extracted information is informative and complements findings from previous research using administrative data.

Seven-Year Outcomes After Hysteroscopic and Laparoscopic Sterilizations.

OBJECTIVE: To evaluate 7-year outcomes after hysteroscopic and laparoscopic sterilizations, including subsequent tubal interventions and hysterectomies. METHODS: This observational cohort study included women undergoing hysteroscopic and laparoscopic sterilizations in outpatient and ambulatory surgical settings in New York State during 2005-2016. We examined subsequent procedures (tubal ligation or resection, and hysterectomy not related to uterine leiomyomas or gynecologic tumors) after the index procedures. After propensity score matching, we used Kaplan-Meier analysis to obtain estimated risks of subsequent procedures within 7 years of index sterilization procedures, and Cox proportional hazard models to compare the differences between groups. RESULTS: We identified 10,143 and 53,206 women who underwent interval hysteroscopic and laparoscopic sterilizations, respectively, in New York State during 2005-2016. The mean age of the cohort was 34.2 years (range 18-80). The propensity score-matched cohort consisted of 10,109 pairs of women. The estimated risk of undergoing an additional tubal ligation or resection within 7 years was higher after hysteroscopic sterilization than it was after laparoscopic sterilization (3.9% vs 1.6%, HR 2.89, 95% CI 2.33-3.57). The difference was most pronounced within the initial year after attempted sterilization (1.5% vs 0.2%; HR 6.39, 95% CI 4.16-9.80). There was no significant difference in the risk of receiving a hysterectomy (0.9% vs 1.2%; HR 0.73, 95% CI 0.53-1.00) between women who underwent hysteroscopic and laparoscopic sterilizations. CONCLUSION: Patients undergoing hysteroscopic sterilization have a higher risk of receiving an additional tubal resection or ligation than those undergoing laparoscopic sterilization, particularly within the first year of the index procedure. There is no difference in undergoing a subsequent hysterectomy between the two groups. With limited evidence of outcomes after hysteroscopic sterilization beyond 7 years and existing reports of removals years after initial implantations, continuous monitoring of long-term outcomes for women who received the device is warranted.

The effect of carbamazepine on etonogestrel concentrations in contraceptive implant users.

OBJECTIVE: The objective was to determine the impact of carbamazepine on the pharmacokinetics and pharmacodynamics of the etonogestrel contraceptive implant. STUDY DESIGN: We enrolled healthy, reproductive-age women using an etonogestrel implant for 1-3 years. We measured etonogestrel levels at baseline and following 3 weeks of coadministered carbamazepine titrated up to 300 mg twice daily. We also evaluated for ovarian follicle-like structures and endometrial thickness using transvaginal ultrasound at the baseline and 3-week visits. RESULTS: We enrolled 13 women; 10 completed study procedures. Participants' mean age was 25.6 years (±5.6), mean body mass index was 30.4 (±7.3), and median duration of implant use was 23 months (range 15-35). The median etonogestrel concentrations before and after carbamazepine coadministration were 158.1 pg/mL (range 128-347) and 50.9 pg/mL (range 39-202), respectively (p=.005). In 8 of 10 subjects, the etonogestrel concentration was below the threshold for ovulatory suppression (<90 pg/mL) after carbamazepine coadministration. The number of ovarian follicle-like structures and endometrial thickness did not significantly change before and after carbamazepine coadministration. CONCLUSIONS: Women using a contraceptive implant experienced significant reductions in etonogestrel concentrations following coadministration of 600 mg of carbamazepine. We did not find significant pharmacodynamic changes during this abbreviated follow-up period. IMPLICATIONS: Carbamazepine use significantly reduces serum etonogestrel concentrations in women using an etonogestrel contraceptive implant, with the majority of participants having etonogestrel concentrations below the threshold for ovulatory suppression. Our findings suggest that treatment with carbamazepine might increase the risk of pregnancy in etonogestrel implant users.

Predictors of Manuscript Publication: A Review of Obstetrics and Gynecology Society Meeting Abstracts.

OBJECTIVE: The authors attempted to understand the manuscript publication rate and predictors of publication of abstracts presented at obstetrical and gynecologic society meetings. METHODS: In 2013, the authors obtained the text of all 2005 abstracts presented at a major generalist- and fellowship-associated society meetings. In this cross-sectional study, a search was completed for publication and identified possible predictors. RESULTS: The authors examined 1405 abstracts; the overall full-text publication rate was 54% (755/1405 publications) and the mean (SD) time to publication was 25.6 (20.8) months. Variables associated with publication in multivariable analysis included number of abstract authors (odds ratio [OR], 1.7; confidence interval [CI], 1.0-1.2), first authorship in American Congress of Obstetricians and Gynecologists district IV (OR, 1.7; CI, 0.9-3.1), prospective design (OR, 1.7; CI, 0.9-3.1), multicenter design (OR, 2.5; CI, 1.3-4.9), and oral presentation (OR, 3.2; CI, 1.4-7.3). Abstracts from specialty meetings were more likely to have these characteristics and, thus, higher publication rates. CONCLUSIONS: This study can guide project development for young researchers by informing them of key study design features associated with manuscript publication.

Safety of first-trimester uterine evacuation in the outpatient setting for women with common chronic conditions.

OBJECTIVE: We compared complications of outpatient first-trimester uterine evacuation between women with medical comorbidities and healthy peers. STUDY DESIGN: We examined the medical histories and procedure outcomes of women receiving first-trimester uterine evacuations between 01/02/2009 and 03/07/2014. We compared women without medical problems to those reporting diabetes, hypertension, obesity (body mass index ≥30.0 or weight ≥200 lbs), HIV, epilepsy, asthma, thyroid disease and/or bleeding/clotting disorders. We compared incidence of any of the following: resuction, uterine perforation, estimated blood loss >100 cc and cervical laceration. RESULTS: A total of 1960 women met inclusion criteria; 597 (30%) had ≥1 comorbidity. When compared to women without medical morbidities, women with common chronic conditions were older (28.3±6.7 vs. 27.3±6.7 years, p<.01), less likely to be primigravid (29.1% vs. 35.7%, p<.01) and more likely to have had a prior cesarean delivery (24.9% vs. 15.7%, p<.001). Gestational age and indication for evacuation were similar for the groups. The overall complication rate was 2.9%. There was no difference in complications between the group of patients with at least one comorbidity compared to the group of women without any comorbidity (OR=0.9, 95% CI 0.5, 1.6). Additionally, there were no specific medical comorbidities that led to an increased complication rate. The only significant predictor of complication was history of cesarean delivery (OR=1.9, 95% CI 1.1, 3.4). CONCLUSION: Women with common chronic conditions undergoing outpatient first-trimester uterine evacuation do not appear to be at greater risk of complications compared to healthy peers. While a careful medical history is always required, providers may feel reassured that complications remain infrequent. IMPLICATIONS: Women with common chronic conditions undergoing outpatient first-trimester uterine evacuation do not appear to be at greater risk of complications compared to healthy peers.

Risk-reducing salpingectomy as preventative strategy for pelvic serous cancer.

The systemic failure to detect early-stage ovarian cancer may be attributed to a significant amount of pelvic serous cancers arising from the fallopian tube rather than the ovarian surface epithelium. This article reviews the possibility of applying risk-reducing salpingectomy as a new paradigm for the prevention of pelvic serous cancer in both high- and low-risk women.

Do new guidelines and technology make the routine pelvic examination obsolete?

Routine pelvic examinations are the core of the periodic gynecological examination and widely tolerated as a necessary part of health maintenance. Is this examination beneficial for asymptomatic women? Justifications for the pelvic examination include screening for Chlamydia (or gonorrhea) infection, evaluation before initiation of hormonal contraception, screening for cervical cancer, and early detection of ovarian cancer. Current nucleic acid amplification tests for Chlamydia and gonorrhea permit the use of urine and self-administered vaginal swabs, which most women prefer over a pelvic examination. Pelvic examination findings do not affect the decision to prescribe or withhold systemic hormonal contraception; a pelvic examination is not needed to initiate these contraceptives. Recent American College of Obstetricians and Gynecologists (ACOG) guidelines recommend less frequent cervical screening, thus decreasing the frequency of a speculum examination for cervical screening. Bimanual examinations for palpation of the uterus and ovaries are also routinely performed in the United States. Clinical trial data, however, show these examinations do not lead to earlier detection of ovarian cancer. No evidence identifies benefits of a pelvic examination in the early diagnosis of other conditions in the asymptomatic woman. Speculum and bimanual examinations are uncomfortable, disliked by many women, and use scarce time during a well woman visit. Eliminating the speculum examination from most visits and the bimanual examination from all visits of asymptomatic women will free resources to provide services of proven benefit. Overuse of the pelvic examination contributes to high healthcare costs without any compensatory health benefit.

Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization.

BACKGROUND: Given the need for a 90-day post-Essure hysterosalpingogram (HSG) to confirm proper tubal placement and occlusion, we examined the impact of dedicating a staff nurse to schedule HSG appointments, call with appointment reminders and track HSG compliance for patients who had Essure. STUDY DESIGN: We performed a retrospective chart review for patients who underwent Essure sterilization between October 2003 and January 2009. We compared rates of HSG compliance and confirmed tubal occlusion for patients before February 2008 with rates after the protocol change occurred. RESULTS: Seventy-eight percent of preintervention patients were compliant with at least one HSG following Essure placement compared to 90.9% in the post-intervention group (p value=.033). Tubal occlusion was confirmed by postprocedure HSGs for 123/173 patients (71.1%) in the preintervention group and 48/55 patients (87.3%) in the postintervention group. Patients followed by our staff after our protocol change were more likely to undergo post-Essure compliance (Odds ratio= 2.7, confidence interval = 1.2-7.1, p=.01). CONCLUSION: Dedicating a staff nurse to track patients' HSG follow-up as a multicheck system resulted in an improvement in HSG compliance and rates of confirmed tubal placement and occlusion.

Sacrocolpopexy without concomitant posterior repair improves posterior compartment defects.

The aim of this study is to determine posterior compartment topography 1-year after sacrocolpopexy (SC). Women who had SC without concomitant anterior or posterior repairs for symptomatic pelvic organ prolapse (POP) were included. Vaginal topography was assessed at baseline and 1-year postoperatively using POP quantification (POPQ). At baseline, 24% had stage IV POP, 68% stage III, and 8% stage II. One year after surgery, 75% had stage 0/I POP, 24% stage II, and 1% stage III. 112 (75%) were objectively cured (stage 0 or I POP). Anterior compartment was the most common site of POP persistence or recurrence (Ba >/= stage II in 23 women) followed by posterior compartment (Bp >/= stage II in 12 women) and apex (C >/= stage II in 2 women). In 1-year follow-up, SC without concomitant posterior repair restores posterior vaginal topography in the majority of women with undergoing SC.