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A Low-Cost Trainer for the Surgical Management of Postpartum Hemorrhage

Chuang, Meleen; Purswani, Heena; Fazzari, Melissa J; Kaplan, Julie; Pardanani, Setul; Banks, Erika H
INTRODUCTION/BACKGROUND:Simulation-based training to manage surgical postpartum hemorrhage allows for improved preparation for these rarely needed life-saving procedures. Our objectives were to design a low-tech simulation model for use in training and evaluation of surgical techniques for the management of postpartum hemorrhage and to present evidence of its validity in assessment and training. METHODS:Fifty-two obstetrics and gynecology residents and 25 attending physicians from an academic hospital were video recorded while performing the O'Leary and B-Lynch techniques on the low-tech model. Performance was evaluated using a Technical Skills Checklist, for B-Lynch and O'Leary techniques, and the Reznick's Global Rating Scale. Interrater reliability was computed to assess the consistency of the ratings between 2 raters. Average scores were determined and compared between incoming residents, junior residents, senior residents, and attending physicians to show construct validity. RESULTS:For the B-Lynch, Technical Skills Checklist scores (maximum 17 points) of attendings (15.04) and senior residents (15.12) were higher than those of junior residents (5.63) and new residents (3.38). Global Rating Scale scores (maximum 25 points) on the B-Lynch reflected the same increase (22.38, 19.35 vs. 8.85, 6.75, respectively). For the O'Leary stitch, the scores of attendings, senior, junior, and incoming residents were as follows: 15.20, 13.65, 11.54, and 2.83, respectively (maximum 19 points). This supports the construct validity of the model. The model was considered realistic and useful for improving surgical skills in 71.4% of participants. CONCLUSIONS:This low-cost, easily constructed model is a useful tool for training these surgical skills.
PMID: 32218092
ISSN: 1559-713x
CID: 5346352

Essentials in Minimally Invasive Gynecology Manual Skills Construct Validation Trial

Munro, Malcolm G; Advincula, Arnold P; Banks, Erika H; Auguste, Tamika C; Chahine, E Britton; Grace Chen, Chi Chiung; Curlin, Howard L; Jorgensen, Elisa M; Kim, Jin Hee; King, Cara R; Lucas, Joelle; Milad, Magdy P; Mourad, Jamal; Siedhoff, Matthew T; Solnik, M Jonathon; Destephano, Christopher C; Thayn, Kim
OBJECTIVE:To establish validity evidence for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems. METHODS:A prospective cohort study was IRB approved and conducted at 15 sites in the United States and Canada. The four participant cohorts based on training status were: 1) novice (postgraduate year [PGY]-1) residents, 2) mid-level (PGY-3) residents, 3) proficient (American Board of Obstetrics and Gynecology [ABOG]-certified specialists without subspecialty training); and 4) expert (ABOG-certified obstetrician-gynecologists who had completed a 2-year fellowship in minimally invasive gynecologic surgery). Qualified participants were oriented to both systems, followed by testing with five laparoscopic exercises (L-1, sleeve-peg transfer; L-2, pattern cut; L-3, extracorporeal tie; L-4, intracorporeal tie; L-5, running suture) and two hysteroscopic exercises (H-1, targeting; H-2, polyp removal). Measured outcomes included accuracy and exercise times, including incompletion rates. RESULTS:Of 227 participants, 77 were novice, 70 were mid-level, 33 were proficient, and 47 were experts. Exercise times, in seconds (±SD), for novice compared with mid-level participants for the seven exercises were as follows, and all were significant (P<.05): L-1, 256 (±59) vs 187 (±45); L-2, 274 (±38) vs 232 (±55); L-3, 344 (±101) vs 284 (±107); L-4, 481 (±126) vs 376 (±141); L-5, 494 (±106) vs 420 (±100); H-1, 176 (±56) vs 141 (±48); and H-2, 200 (±96) vs 150 (±37). Incompletion rates were highest in the novice cohort and lowest in the expert group. Exercise errors were significantly less and accuracy was greater in the expert group compared with all other groups. CONCLUSION/CONCLUSIONS:Validity evidence was established for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems by distinguishing PGY-1 from PGY-3 trainees and proficient from expert gynecologic surgeons.
PMID: 32541289
ISSN: 1873-233x
CID: 4484622

ACOG Simulation Working Group: A Needs Assessment of Simulation Training in OB/GYN Residencies and Recommendations for Future Research

DeStephano, Christopher C; Nitsche, Joshua F; Heckman, Michael G; Banks, Erika; Hur, Hye-Chun
OBJECTIVE:To evaluate current availability and needs of simulation training among obstetrics/gynecology (OB/GYN) residency programs. DESIGN/METHODS:Cross-sectional survey. SETTING/METHODS:Accreditation Council for Graduate Medical Education accredited OB/GYN residency programs in the United States. PARTICIPANTS/METHODS:Residency program directors, gynecology simulation faculty, obstetrics simulation faculty, and fourth-year residents. RESULTS:Of 673 invited participants, 251 (37.3%) completed the survey. Among the survey responses, OB procedures were more broadly represented compared to the GYN procedures for simulation teaching: 8 (50%) of 16 OB procedures versus 4 (18.2%) of 22 GYN procedures had simulation teaching. Among the simulated procedures, a majority of residents and faculty reported that simulation teaching was available for operative vaginal delivery, postpartum hemorrhage, shoulder dystocia, perineal laceration repair, conventional laparoscopic procedures, and robotic surgery. There were significant differences between residents and faculty perceptions regarding the availability and needs of simulated procedures with a minority of residents having knowledge of Council on Resident Education in Obstetrics and Gynecology (47.2%) and American College of Obstetrics and Gynecology (27.8%) simulation tools compared to the majority of faculty (84.7% and 72.1%, respectively). More than 80% of trainees and faculty reported they felt the average graduating resident could perform vaginal, laparoscopic, and abdominal hysterectomies independently. CONCLUSIONS:Simulation is now widely available for both gynecologic and obstetric procedures, but there remains tremendous heterogeneity between programs and the perceptions of residents, program directors, and faculty. The variations in simulation training and readiness for performing different procedures following residency support the need for objective, validated assessments of actual performance to better guide resident learning and faculty teaching efforts.
PMID: 31859227
ISSN: 1878-7452
CID: 5111312

In Reply [Comment]

Gressel, Gregory M; Banks, Erika
PMID: 32332404
ISSN: 1873-233x
CID: 5346362

Hysterectomy Route and Numbers Reported by Graduating Residents in Obstetrics and Gynecology Training Programs

Gressel, Gregory M; Potts, John R; Cha, Sandolsam; Valea, Fidel A; Banks, Erika
OBJECTIVE:To characterize trends in self-reported numbers and routes of hysterectomy for obstetrics and gynecology residents using the Accreditation Council for Graduate Medical Education (ACGME) case log database. METHODS:Hysterectomy case log data for obstetrics and gynecology residents completing training between 2002-2003 and 2017-2018 were abstracted from the ACGME database. Total numbers of hysterectomies and modes of approach (abdominal, laparoscopic, and vaginal) were compared using bivariate statistics, and trends over time were analyzed using simple linear regression. RESULTS:Hysterectomy data were collected from 18,982 obstetrics and gynecology residents in a median of 243 (interquartile range 241-246) ACGME-accredited programs. The number of graduating residents increased significantly over time (12.1/year, P<.001), whereas the number of residency programs decreased significantly (0.52 fewer programs per year, P<.001) over the 16-year period. For cases logged as "surgeon," the median number of abdominal hysterectomies decreased by 56.5% from 85 (interquartile range 69-102) to 37 (interquartile range 34-43) (P<.001). The median number of vaginal hysterectomies decreased by 35.5% from 31 (interquartile range 24-39) to 20 (interquartile range 17-25) (P=.002). The median total number of hysterectomies per resident decreased by 6.3% from 112 (interquartile range 97-132) to 105 (interquartile range 92-121) (P=.036). In contrast, the median number of laparoscopic hysterectomies increased by 115% from 20 (interquartile range 13-28) in 2008-2009 to 43 (interquartile range 32-56) in 2017-2018, despite the decrease in overall number of hysterectomies (P<.001). These trends were statistically significant. CONCLUSIONS:The total number of hysterectomies performed by obstetrics and gynecology residents in the United States is decreasing, and the routes are changing with decreases in abdominal and vaginal approaches, and an increase in use of laparoscopic hysterectomy.
PMID: 31923067
ISSN: 1873-233x
CID: 5346342

Direct Costs Incurred Among Women Undergoing Surgical Procedures to Treat Uterine Fibroids

Harrington, Amanda; Bonine, Nicole G; Banks, Erika; Shih, Vanessa; Stafkey-Mailey, Dana; Fuldeore, Rupali M; Yue, Binglin; Ye, Jiatao Michael; Ta, Jamie T; Gillard, Patrick
BACKGROUND:Uterine fibroids (UF) affect up to 70%-80% of women by 50 years of age and represent a substantial economic burden on patients and society. Despite the high costs associated with UF, recent studies on the costs of UF-related surgical treatments remain limited. OBJECTIVE:To describe the health care resource utilization (HCRU) and all-cause costs among women diagnosed with UF who underwent UF-related surgery. METHODS:Data from the IBM MarketScan Commercial Claims and Encounters database and Medicaid Multi-State database were independently, retrospectively analyzed from January 1, 2009, to December 31, 2015. Women aged 18-64 years with ≥ 1 UF claim from January 1, 2010, to December 31, 2014, a claim for a UF-related surgery (hysterectomy, myomectomy, uterine artery embolization [UAE], or ablation) from January 1, 2010, to November 30, 2015, and continuous enrollment for ≥ 1 year presurgery and ≥ 30 days postsurgery qualified for study inclusion. A 1-year period before the date of the first UF-related surgical claim after the first UF diagnosis was used to report baseline demographic and clinical characteristics. Surgery characteristics were reported. All-cause HCRU and costs (adjusted to 2017 U.S. dollars) were described by the 14 days pre-, peri-, and 30 days postoperative periods, and independently by the inpatient or outpatient setting. RESULTS:Overall, 113,091 patients were included in this study: commercial database, n = 103,814; Medicaid database, n = 9,277. Median time from the initial UF diagnosis to first UF-related surgical procedure was 33 days for the commercial population and 47 days for the Medicaid population. Hysterectomy was the most common UF-related surgery received after UF diagnosis (commercial, 68% [n = 70,235]; Medicaid, 75% [n = 6,928]). In both populations, 97% of patients had ≥ 1 outpatient visit from 14 days presurgery to 30 days postsurgery (commercial, n = 100,402; Medicaid, n = 9,023), and the majority of all UF-related surgeries occurred in the outpatient setting (commercial, 64% [n = 66,228]; Medicaid, 66% [n = 6,090]). Mean total all-cause costs for patients with UF who underwent any UF-related surgery were $15,813 (SD $13,804) in the commercial population (n = 95,433) and $11,493 (SD $26,724) in the Medicaid population (n = 4,785). Mean total all-cause costs for UF-related surgeries for the commercial/Medicaid populations were $17,450 (SD $13,483)/$12,273 (SD $19,637) for hysterectomy, $14,216 (SD $16,382)/$11,764 (SD $15,478) for myomectomy, $17,163 (SD $13,527)/$12,543 (SD $23,777) for UAE, $8,757 (SD $9,369)/$7,622 (SD $50,750) for ablation, and $12,281 (SD $10,080)/$5,989 (SD $5,617) for myomectomy and ablation. Mean total all-cause costs for any UF-related surgery performed in the outpatient setting in the commercial and Medicaid populations were $14,396 (SD $11,466) and $6,720 (SD $10,374), respectively, whereas costs in the inpatient setting were $18,345 (SD $16,910) and $21,805 (SD $43,244), respectively. CONCLUSIONS:This retrospective analysis indicated that surgical treatment options for UF continue to represent a substantial financial burden. This underscores the need for alternative, cost-effective treatments for the management of UF. DISCLOSURES/BACKGROUND:This study was sponsored by Allergan, Dublin, Ireland. Allergan played a role in the conduct, analysis, interpretation, writing of the report, and decision to publish this study. Harrington and Ye are employees of Allergan. Stafkey-Mailey, Fuldeore, and Yue are employees of Xcenda. Ta was a contractor at Allergan at the time the study was conducted and is currently supported by a training grant from Allergan. Bonine, Shih, and Gillard are employees of Allergan and have stock, stock options, and/or restricted stock units as employees of Allergan. Banks has no disclosures to report. This study was presented as a poster at Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.
PMID: 31958025
ISSN: 2376-1032
CID: 5372322

Healthcare resource utilization and costs among women diagnosed with uterine fibroids compared to women without uterine fibroids

Shih, Vanessa; Banks, Erika; Bonine, Nicole G; Harrington, Amanda; Stafkey-Mailey, Dana; Yue, Binglin; Ye, Jiatao Michael; Fuldeore, Rupali M; Gillard, Patrick
PMID: 31290716
ISSN: 1473-4877
CID: 5346322

Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol

Scalia, Peter; Durand, Marie-Anne; Forcino, Rachel C; Schubbe, Danielle; Barr, Paul J; O'Brien, Nancy; O'Malley, A James; Foster, Tina; Politi, Mary C; Laughlin-Tommaso, Shannon; Banks, Erika; Madden, Tessa; Anchan, Raymond M; Aarts, Johanna W M; Velentgas, Priscilla; Balls-Berry, Joyce; Bacon, Carla; Adams-Foster, Monica; Mulligan, Carrie Cahill; Venable, Sateria; Cochran, Nancy E; Elwyn, Glyn
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.
PMCID:6721118
PMID: 31477140
ISSN: 1748-5908
CID: 5346332

Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials

Archer, David F; Merkatz, Ruth B; Bahamondes, Luis; Westhoff, Carolyn L; Darney, Philip; Apter, Dan; Jensen, Jeffrey T; Brache, Vivian; Nelson, Anita L; Banks, Erika; Bártfai, György; Portman, David J; Plagianos, Marlena; Dart, Clint; Kumar, Narender; Creasy, George W; Sitruk-Ware, Regine; Blithe, Diana L
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.
PMID: 31231065
ISSN: 2214-109x
CID: 5346312

Low-Fidelity Cystoscopy Simulation in Ob/Gyn Residents and Skills Retention [Meeting Abstract]

Riano, Ervin; Banks, Erika; To, Justin; Lu, Chunhua; Movva, Vani
ISI:000454042000092
ISSN: 0029-7844
CID: 5346522