Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial.

Importance: Postpartum human papillomavirus (HPV) vaccination is a promising strategy to increase HPV vaccination uptake in the US, particularly for reaching vaccine-naive women and those who lack health insurance beyond the pregnancy period. However, completion of the 3-dose vaccine regimen is challenging. Objective: To evaluate the immunogenicity of a 2-dose postpartum HPV vaccination regimen (0 and 6 months) and assess whether it is noninferior to a 3-dose postpartum HPV vaccination regimen (0, 1-2, and 6 months) administered to historical controls. Design, Setting, and Participants: A noninferiority, open-label, nonrandomized immunogenicity trial was conducted from August 4, 2020, to June 23, 2022, of postpartum patients aged 15 to 45 years who delivered at 2 hospitals in Baltimore, Maryland. Historical controls were adolescents and young women aged 16 to 26 years. Intervention: Two doses of the nonavalent HPV vaccine administered 6 months apart. Main Outcomes and Measures: The primary outcome was noninferiority (90% CI, lower bound >0.67) of the geometric mean titer (GMT) ratio for HPV-16 among postpartum women compared with historical controls. Secondary outcomes were noninferiority of GMT ratios for the other 8 HPV types and percentage seroconversion for each HPV type. As a noninferiority trial, the primary analysis used the per-protocol analysis. Results: Of 225 enrolled participants, the mean (SD) age at baseline was 29.9 (6.8) years, and 171 (76.0%) were HPV-16 seronegative at baseline. Of these 171 participants, 129 (75.4%) received a second vaccine dose and completed the subsequent 4-week serologic measurements. Relative to historical controls, the HPV-16 GMT ratio was 2.29 (90% CI, 2.03-2.58). At month 7, HPV-16 GMT was higher after the 2-dose regimen (7213.1 mMU/mL [90% CI, 6245.0-8331.4 mMU/mL]) than among historic controls after the 3-dose regimen (3154.0 mMU/mL [90% CI, 2860.2-3478.0 mMU/mL]). Similarly, the lower bound of the 90% CI of the GMT ratio was above 1 for the 8 HPV types 6, 11, 18, 31, 33, 45, 52, and 58. A total of 118 of 134 women (88.1%) seroconverted for HPV-16 after the first dose; 4 weeks after the second dose, the seroconversion rate was 99% or greater for all HPV types. Conclusions and Relevance: This study suggests that immunogenicity of a 2-dose HPV vaccination regimen given 6 months apart among postpartum women was noninferior to a 3-dose regimen among young historical controls. Most women seroconverted after the first dose of the 2-dose regimen. These results demonstrate that postpartum vaccination using a reduced schedule may be a promising strategy to increase HPV vaccine series completion. Trial Registration: ClinicalTrials.gov Identifier: NCT04274153.

The association between race/ethnicity and peripartum hysterectomy and the risk of perioperative complications.

OBJECTIVE: To compare perioperative outcomes by patient race/ethnicity. METHODS: A retrospective cohort study identified 7 331 638 childbirth hospitalizations for women aged 12-55 years in the USA between 2004-2014. Peripartum hysterectomy, in-hospital mortality, perioperative complications, length of stay, and cost of hysterectomy data were analyzed using SAS. RESULTS: Among childbirth hospitalizations (52.9% white, 13.5% black, 23.0% Hispanic, 5.2% Asian, and 5.4% other), peripartum hysterectomy occurred in 6619. The incidence of peripartum hysterectomy was 90.3 (95% confidence interval [CI] 87.7-93.0) per 100 000 hospitalizations, and higher for black (111.0, 95% CI 104.5-117.4), Hispanic (104.9, 95% CI 99.1-110.8), and Asian women (119.6, 95% CI 109.1-130.2) compared to whites (75.7, 95% CI 72.8-78.5). After adjustment, Hispanic women had an 18% higher odds of undergoing peripartum hysterectomy (odds ratio [OR] 1.18, 95% CI 1.08-1.29; P=0.004) than white women. Non-white women had a 2-3-fold higher odds of in-hospital mortality (ORblack 2.76, 95% CI 1.44-5.30; ORHispanic 1.99, 95% CI 1.04-3.82; ORAsian+other 2.44, 95% CI 1.11-5.40. Black and Asian/other women were more likely to undergo blood transfusions. CONCLUSION: Women of color have higher rates of peripartum hysterectomy and experience higher rates of poor perioperative outcomes and mortality.

Career Interest and Psychomotor Aptitude Among Medical Students.

OBJECTIVE: The primary objective is to assess psychomotor aptitude of medical students interested in pursuing a procedural career. Secondary objectives include exploring the relationship between actual and perceived aptitude, and identifying predictors of superior aptitude. DESIGN: This is a cross-sectional, multisite study in which participants completed a paper survey, four visuospatial aptitude assessments, and a laparoscopic simulation modeled after the Fundamentals of Laparoscopic Surgery (FLS) peg transfer test (used as a proxy for psychomotor aptitude). SETTING: Johns Hopkins University School of Medicine and Mayo Clinic School of Medicine. PARTICIPANTS: All second-year medical students who had not yet initiated clinical rotations were eligible. Sixty-four students participated. RESULTS: Students interested in a procedural career exhibited superior psychomotor aptitude (faster FLS task completion time), and a majority of these students correctly identified themselves as having above-average aptitude compared with peers. However, over one quarter of all students, regardless of career interest, incorrectly over- or under-rated their psychomotor aptitude. Upon completing their preclinical curriculum, a minority of students felt prepared to participate or assist in their surgical clinical rotations. CONCLUSIONS: Prior to embarking on their clinical rotations, over one quarter of medical students lack awareness of their psychomotor aptitude and many do not feel prepared to participate in the next phase of their training. Early aptitude testing and introduction to laparoscopic training may assist in career selection, preparedness, and success.

Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies.

Several lines of evidence suggest that children born via Cesarean section (C-section) are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients.

Choosing a women's health career.

BACKGROUND: In 2005, in response to a decline in residency applications in obstetrics and gynecology (OB GYN), the American College of Obstetrics and Gynecology Presidential Task Force outlined strategies for attracting medical students to OB GYN. Application rates have increased since then, but little is known about which interventions are effective. We aimed to identify modifiable and nonmodifiable variables that may contribute to students choosing OB GYN for their careers; this information could be used to inform curriculum design, faculty development, and innovative exposures to women's health. METHODS: This qualitative study received institutional review board approval. Eligible participants were students who applied or recently matched into OB GYN residency programs from the class of 2014-2016 at our institution. Students were interviewed with open-ended questions and a Likert-type survey. Thematic analysis was performed. RESULTS: Ten qualitative interviews were completed and analyzed. Intrinsic themes such as the potential for a meaningful job in women's health, advocacy for women, or empowerment of women were identified as factors contributing to participant career choice. Extrinsic themes such as positive impressions during the clinical clerkship and welcoming teams were also identified. Most students indicated that the clerkship was the most influential experience. CONCLUSIONS: Participants identified important events, including some that even preceded medical school that guided them toward OB GYN. The data guide us to consider the importance of emphasizing the unique combination of characteristics in OB GYN and improving the learning environment in the clerkship as a way to encourage student recruitment.

Predictors of Human Papillomavirus Vaccination in a Large Clinical Population of Males Aged 11 to 26 years in Maryland, 2012-2013.

BACKGROUND: Despite the recommendation for routine human papillomavirus (HPV) vaccination in males, coverage estimates remain low. We sought to identify predictors of receiving each HPV vaccine dose among a large clinical population of males. METHODS: We conducted a cross-sectional analysis of electronic medical records for 14,688 males ages 11 to 26 years attending 26 outpatient clinics (January 2012-April 2013) in Maryland to identify predictors of each HPV vaccine dose using multivariate logistic regression models with generalized estimating equations. All analyses were stratified in accordance with vaccine age recommendations: 11 to 12 years, 13 to 21 years, and 22 to 26 years. Analyses of predictors of receipt of subsequent HPV doses were also stratified by the number of clinic visits (≤3 and >3). RESULTS: Approximately 15% of males initiated the HPV vaccine. Less than half of males eligible received the second and third doses, 49% and 47%, respectively. Non-Hispanic black males (vs. non-Hispanic white) ages 11 to 12 and 13 to 21 years and males with public insurance (vs. private) ages 13 to 21 years had significantly greater odds of vaccine initiation, but significantly decreased odds of receiving subsequent doses, respectively. Attendance to >3 clinic visits attenuated the inverse association between public insurance and receipt of subsequent doses. CONCLUSION: Overall, rates of HPV vaccine initiation and of subsequent doses were low. While non-Hispanic black and publicly insured males were more likely to initiate the HPV vaccine, they were less likely to receive subsequent doses. IMPACT: Tailoring different intervention strategies for increasing HPV vaccine initiation versus increasing rates of subsequent doses among males may be warranted.

A randomized controlled trial of birth simulation for medical students.

OBJECTIVE: The objective of the study was to evaluate the effectiveness of a high-fidelity birth simulator (Noelle; Gaumard Scientific, Coral Gables, FL) compared with a lower-cost, low-tech, birth simulator (MamaNatalie; Laerdal Medical, Stavanger, Norway) in teaching medical students how to perform a spontaneous vaginal delivery (SVD). STUDY DESIGN: Prior to the obstetrics-gynecology clerkship, students were randomly assigned to 2 groups. The MamaNatalie group (MG) completed 45 minutes of SVD simulation using an obstetrical abdominal-pelvic model worn by an obstetrics-gynecology faculty member. The Noelle group (NG) completed 45 minutes of SVD simulation using a high-fidelity, computer-controlled mannequin facilitated by an obstetrics-gynecology faculty member. The primary outcome was student performance during his or her first SVD as rated by supervising preceptors. Surveys were also completed by students on confidence in performing steps of a SVD (secondary outcome). RESULTS: One hundred ten medical students (95% of those eligible) participated in this research study. The final postclerkship survey was completed by 93 students (85% follow-up rate). There were no significant differences in performance of SVD steps between MG and NG students as rated by preceptors. The SVD step with the least involvement by students was controlling the head (20.5% in MG, 23.3% in NG performed step with hands-off supervision). Delivery of the placenta was the SVD step with the most involvement (65.9% in MG, 52.3% in NG performed step with hands-off supervision). Baseline presimulation confidence levels were similar between MG and NG. On the immediate postsimulation survey of confidence, MG students were significantly more confident in their ability to deliver the abdomen and legs and perform fundal massage with hands-off supervision (P < .05) than NG students. Following the clerkship, MG students were significantly more confident in their ability to control the head and deliver the abdomen and legs (P < .05) than NG students. CONCLUSION: MamaNatalie is as effective as Noelle in training medical students how to perform a SVD and may be a useful, lower-cost alternative in teaching labor and delivery skills to novice learners. Because birth simulation interventions involve both a simulation model and facilitator, research is required to further determine the effect of human interaction on learning outcomes.

Warm-up on a simulator improves residents' performance in laparoscopic surgery: a randomized trial.

INTRODUCTION AND HYPOTHESIS: Our aim was to assess the impact of immediate preoperative laparoscopic warm-up using a simulator on intraoperative laparoscopic performance by gynecologic residents. METHODS: Eligible laparoscopic cases performed for benign, gynecologic indications were randomized to be performed with or without immediate preoperative warm-up. Residents randomized to warm-up performed a brief set of standardized exercises on a laparoscopic trainer immediately before surgery. Intraoperative performance was scored using previously validated global rating scales. Assessment was made immediately after surgery by attending faculty who were blinded to the warm-up randomization. RESULTS: We randomized 237 residents to 47 minor laparoscopic cases (adnexal/ tubal surgery) and 44 to major laparoscopic cases (hysterectomy). Overall, attendings rated upper-level resident performances (postgraduate year [PGY-3, 4]) significantly higher on global rating scales than lower-level resident performances (PGY-1, 2). Residents who performed warm-up exercises prior to surgery were rated significantly higher on all subscales within each global rating scale, irrespective of the difficulty of the surgery. Most residents felt that performing warm-up exercises helped their intraoperative performances. CONCLUSION: Performing a brief warm-up exercise before a major or minor laparoscopic procedure significantly improved the intraoperative performance of residents irrespective of the difficulty of the case.

Teaching subcuticular suturing to medical students: video versus expert instructor feedback.

OBJECTIVE: Given limitations in surgical educational resources, more efficient teaching methods are needed. We sought to evaluate 3 strategies for improving skills in subcuticular suturing-practice with an instructional video, practice with expert instructor supervision, and independent practice. DESIGN: Fifty-eight medical students volunteered for this research. Students viewed a video on subcuticular suturing then completed a pretest requiring closure of an incision in a plastic model. Students were randomized among 3 groups: practice with an instructional video (group A), practice with supervision by an expert instructor (group B), and independent practice (group C). After instruction, students completed a posttest, then a retention test 1 week later. Their performances were video recorded and evaluated using a validated scoring instrument composed of global and task-specific subscales. RESULTS: Performances measured using both subscales improved significantly from pretest to post-test only for group B. However, when comparing student performances between pretest and retention posttest, significant improvements on both subscales were seen only in group A. CONCLUSION: These results suggest that practice with an instructional video is an effective method for acquiring skill in subcuticular suturing.

Disparities in human papillomavirus vaccine completion among vaccine initiators.

OBJECTIVE: To estimate rates of completing the full three-dose prophylactic human papillomavirus (HPV) vaccination regimen in patients who initiated the series and to identify variables associated with not completing vaccination. METHODS: This single-institution review identified all patients initiating HPV vaccination at one of four affiliated clinics between January 2007 and June 2008. Vaccination "completers" were defined as patients who had completed all three vaccinations within 12 months of initiating the vaccination series. Logistic regression was used to identify factors associated with vaccine completion. Variables analyzed included age, type of insurance (private compared with public), practice location (urban compared with suburban), practice type (pediatrics, gynecology, or family practice), and race or ethnicity (white or African American and Hispanic). RESULTS: Of the 1,413 girls and young women who initiated HPV vaccination, 469 (33.2%) completed the vaccine series. Overall, private insurances (odds ratio 1.87, 95% confidence interval 1.26-2.76) and suburban practice locations (odds ratio 1.44, 95% confidence interval 1.04-1.98) were associated with higher vaccine completion rates. African American race was associated with lower completion rates (odds ratio 0.50, 95% confidence interval 0.38-0.65). In multivariable analyses, the combination of younger age (11-17 years) and urban practice location was associated with very low likelihood of completing HPV vaccination (22%; P=.023). CONCLUSION: The HPV vaccine completion rate is low. When resources are limited, disparities in HPV vaccine completion should be considered when developing programs to improve vaccine utilization. Urban girls and young women should be targeted as an at-risk population.

Validation of an instrument for evaluation of subcuticular suturing using a plastic tissue model.

OBJECTIVE: To collect evidence for the validity and reliability of an assessment tool for simulated subcuticular suturing. STUDY DESIGN: Three subjects were videotaped while closing a simulated incision in a plastic model. The 3 trials were viewed independently by 7 faculty examiners masked to subject identity. Global rating and task-specific scales were used to assess subject competence. The mean scores were compared among the 3 subjects and 7 evaluators using analysis of variance. RESULTS: Significant differences were found among the mean global rating scores for the 3 subjects but not among the evaluators. Similarly, significant differences were found between mean task-specific scale scores for the 3 subjects but not among the evaluators. Cronbach's alpha for global rating (0.89) and task-specific (0.93) scores suggested high internal consistency for each scale. CONCLUSIONS: These findings provide evidence for the discriminant validity, internal consistency, and inter-rater reliability of both the global rating and task-specific scales of our assessment tool.

Evaluating the competency of gynecology residents in the operating room: validation of a new assessment tool.

OBJECTIVE: The purpose of this study was to develop and validate a brief, reliable rating scale to measure resident surgical competency. STUDY DESIGN: For 12 months, the gynecology faculty at Johns Hopkins Bayview Medical Center completed a prototype global rating scale after each surgery. Concurrently, each resident completed the same assessment form as a self-evaluation. Factor analysis, Cronbach's alpha, Pearson correlations, and one-way analysis of variance were used to evaluate internal consistency and validity. RESULTS: Using factor analysis, the assessment form was modified to create the Hopkins Assessment of Surgical Competency (HASC). This contained 2 scales, General Surgical Skills and Case Specific Surgical Skills. The Cronbach's alpha ranged from 0.86 to 0.89. The item-scale Pearson correlations ranged from 0.74 to 0.87. Senior residents scored significantly higher than junior residents and last rotation scores were significantly higher than the first. CONCLUSION: The HASC is a concise, valid, and reliable tool for assessing surgical competency in the clinical setting.

Simulators and virtual reality in surgical education.

This article explores the pros and cons of virtual reality simulators, their abilities to train and assess surgical skills, and their potential future applications. Computer-based virtual reality simulators and more conventional box trainers are compared and contrasted. The virtual reality simulator provides objective assessment of surgical skills and immediate feedback further to enhance training. With this ability to provide standardized, unbiased assessment of surgical skills, the virtual reality trainer has the potential to be a tool for selecting, instructing, certifying, and recertifying gynecologists.

Decreased incidence of cervical cancer in medicare-eligible California women.

OBJECTIVE: To determine if the incidence of invasive cervical cancer relative to carcinoma in situ decreased in Medicare-eligible women. METHODS: A retrospective cohort was amassed from the California Cancer Registry database. The hypothesis was prospectively specified. Mean ratio of invasive (International Federation of Gynecology and Obstetrics Stages I-IV) to in situ cervical carcinoma in 1988-1990 versus 1991-1995 was stratified by age (24 or younger, 25-44, 45-64, 65 or older) and race (all races, whites, blacks, Hispanics, Asian/Pacific Islanders). RESULTS: The mean ratio of invasive to in situ cervical cancer incidence for women at least 65 years old was lower in 1991-1995 compared with 1988-1990 (P <.001, 95% confidence interval 0.893, 0.954); and had decreased more than observed for women aged 45-64 and 25-44, for all races combined, and for white women. The decreased ratio of invasive to in situ cancer for blacks, Hispanics, and Asian/Pacific Islanders at least 65 years old was no different than the decreased ratio in younger women. CONCLUSION: In California, in the 5 years after the 1990 change in Medicare funding statutes for cervical cytology screening, the ratio of invasive cervical cancer to in situ disease decreased more in Medicare-eligible patients than in younger women.