Standard quality criteria in retracted vs nonretracted obstetrical randomized controlled trials.

BACKGROUND: The number of retracted articles in peer-reviewed journals is increasing within the field of obstetrics. The most common reason for article retraction is scientific misconduct. Unfortunately, article retraction often occurs years after publication, allowing inaccurate data to be widely distributed to readers. There exists a great need for validated screening criteria for obstetric journals to use when reviewing randomized controlled trials for scientific misconduct. OBJECTIVE: This study aimed to compare retracted obstetric randomized controlled trials with nonretracted randomized controlled trials with regard to their inclusion of 7 quality metrics: prospective trial registration, trial registration number, ethics approval statement, name of the approving committee, statement of informed consent, adherence to the Consolidated Standards of Reporting Trials guidelines, and a data sharing statement. STUDY DESIGN: Obstetric randomized controlled trials retracted between 1995 and 2021 identified through Retraction Watch were compared with nonretracted randomized controlled trials published between 2018 and 2020 with regard to inclusion of the 7 quality metrics. The main outcome was the difference in prospective trial registration. Secondary outcomes were the percentage of individual criteria met and the screening performance of quality criteria in predicting article retraction. RESULTS: A total of 150 randomized controlled trials were identified, of which 14 (9.3%) were retracted and 136 (90.7%) nonretracted. Retracted randomized controlled trials were less likely than nonretracted randomized controlled trials to be prospectively registered (14.3% vs 80.1%; P<.001). The median number of quality criteria met was lower for retracted randomized controlled trials (3 vs 6; P<.01). Using a cutoff of ≤4 criteria was associated with 85.7% (95% confidence interval, 57.2-98.2) sensitivity and 92.0% (95% confidence interval, 86.2-96.0) specificity in distinguishing the retracted randomized controlled trials from nonretracted studies. CONCLUSION: Retracted obstetric randomized controlled trials were less likely to include the 7 quality metrics required on submission by most top obstetrics and gynecology journals.

Effects of delayed cord clamping on neonatal hyperbilirubinemia in pre-gestational diabetes at term.

OBJECTIVE: To evaluate the effects of delayed cord clamping on neonatal hyperbilirubinemia in infants born to patients diagnosed with pre-gestational diabetes (type I or type II). METHODS: In January 2016, our institution implemented an organization-wide thirty-second delayed cord clamping protocol. This retrospective cross-sectional study represents infants of mothers diagnosed with pre-gestational diabetes who delivered before and after protocol implementation. The study period was from October 2014 to August 2017. The primary outcome was peak neonatal transcutaneous bilirubin (mg/dL) level during neonatal hospital stay. The secondary outcomes included neonatal serum bilirubin (mg/dL), jaundice requiring phototherapy, hypoglycemia, polycythemia, respiratory distress, and neonatal intensive care unit (NICU) admission. A subgroup analysis for outcomes stratified by type of pre-gestational diabetes was also performed. RESULTS: 145 patients were included in the final analysis. The mean peak neonatal transcutaneous bilirubin level was 10.1 mg/dL ± 3.4 mg/dL for immediate cord clamping and 9.5 mg/dL ± 3.4 mg/dL for delayed cord clamping (p = .25). There were no significant differences between groups for neonatal jaundice requiring phototherapy, hypoglycemia, polycythemia, respiratory distress, or NICU admission. No differences were observed in neonatal outcome by subgroup analysis of pre-gestational diabetes type. CONCLUSION: In our study, there was no significant increase in peak neonatal transcutaneous bilirubin in term (≥37 week) infants of mothers with pre-gestational diabetes after undergoing thirty-seconds of delayed cord clamping. In the absence of contraindications, we advocate for continued use of delayed cord clamping for these infants.

Newly diagnosed immune thrombocytopenia in a pregnant patient after coronavirus disease 2019 vaccination.

Over 26 million cases of coronavirus disease 2019 (COVID-19) have been reported in the United States with over 440 000 deaths. Despite COVID-19 vaccine approval, pregnant women were excluded from clinical trials. We report a case of immune thrombocytopenia in the first trimester, which occurred 13 days after initiating the COVID-19 vaccination series. Thorough evaluation, including hematology consultation, established the diagnosis. High-dose oral corticosteroids were started, and she was discharged home with significant improvement in platelet count on her fourth day of hospitalization with no subsequent complications. We advocate that the benefits of COVID-19 vaccination outweigh the risk of infection in pregnancy and that pregnant women should be included in clinical trials. Closer post-vaccination surveillance may be warranted in the pregnant population pending further data.

Reported case numbers and variability in delivery route and volume by obstetrics and gynecology residents from 2003 to 2019.

BACKGROUND: The obstetrical landscape in the United States has changed over the past several decades, during which there has been a decline in the number of operative vaginal deliveries performed. Procedural cases of obstetrics and gynecology residents are tracked in the Accreditation Council for Graduate Medical Education database, with a minimum requirement of 15 operative vaginal deliveries before graduation. Nowadays, it is unknown whether the decreasing numbers of operative vaginal deliveries are affecting the delivery case volume and experience of obstetrics and gynecology residents. OBJECTIVE: This study aimed to analyze the trends in the number and route of obstetrical deliveries, including operative vaginal deliveries, performed by graduating obstetrics and gynecology residents in the United States as logged within the Accreditation Council for Graduate Medical Education database. STUDY DESIGN: The Accreditation Council for Graduate Medical Education case log data were examined for graduating obstetrics and gynecology residents between 2003 and 2019. Delivery case volume numbers for spontaneous vaginal delivery, cesarean delivery, forceps-assisted vaginal delivery, and vacuum-assisted vaginal delivery were extracted and analyzed over time using linear regression. To compare the variability in logged cases, residents at the 70th percentile for number of cases logged were compared with residents at the 30th percentile for number of cases logged for each delivery type (spontaneous vaginal delivery, cesarean delivery, forceps-assisted vaginal delivery, and vacuum-assisted vaginal delivery). RESULTS: Overall, obstetrical delivery data for 20,268 obstetrics and gynecology residents were collected from 2003 to 2019. Over this period, the mean number of spontaneous vaginal deliveries significantly decreased over time by 20% from 320.8±138.7 to 256.1±75.6 (slope, -2.6; P<.001); however, no significant difference was noted in the reported cesarean delivery cases, with an 8% increase from 191.8±80.1 to 206.8±69.7 per graduating resident (slope, 0.136; P=.873). Notably, the mean reported cases of forceps-assisted vaginal deliveries decreased by 75% from 23.8±21.9 to 6±6.8 per graduating resident (slope, -0.851; P<.001). Similarly, the mean logs of vacuum-assisted vaginal delivery decreased by 37% from 23.8±17.1 to 15±9.5 (slope, -0.542; P<.001). The ratio of reported resident case logs comparing the volume at the 70th percentile with the volume at the 30th percentile demonstrated a significant decrease over time for spontaneous vaginal delivery (slope, -0.015; P<.001), cesarean delivery (slope, -0.015; P<.001), and vacuum-assisted vaginal delivery (slope, -0.033; P<.001) but was significantly increased for forceps-assisted vaginal delivery (slope, 0.07, P=.0065). CONCLUSION: In the reported Accreditation Council for Graduate Medical Education case logs, we identified that the reported number of obstetrical deliveries performed by obstetrics and gynecology residents in the United States is changing, with a significant decline recognized from 2003 to 2019 in logged numbers of spontaneous vaginal deliveries, vacuum-assisted vaginal deliveries, and forceps-assisted vaginal deliveries, without a difference in reported cesarean delivery cases per graduating resident. Furthermore, substantial variation is seen among resident volume nationwide, with the difference in high- and low-volume resident forceps-assisted vaginal delivery experience increasing over time. Awareness of these data should notify the Accreditation Council for Graduate Medical Education and educators about reasonable targets, increased need for simulation, and new ways to teach all modes of deliveries effectively in all residency programs.

Uterine Transplantation: Evolving Data, Success, and Clinical Importance.

Uterine transplantation is an evolving procedure to allow for childbearing in paitents with absolute uterine factor infertility. The objective of this study was to review the existing literature using a comprehensive PubMed literature search. A systematic medical subheadings search strategy was used with the terms "uterus transplant" and "uterine transplantation". Of the 75 full-text articles assessed for eligibility, 68 were included in the qualitative synthesis. Of these, 9 were included in the meta-analysis on living donor uterine transplant, 5 on deceased donor uterine transplant, and 6 case reports of single uterine transplants. In conclusion, uterus transplant is a nascent field undergoing a rapid rate of evolution as programs mature their data and increase the number of procedures performed. The most recent publications and advances are thus summarized in this article to capture the most up-to-date information.

Predictors of response to immune checkpoint inhibition in a real world gynecologic cancer population.

Prognostic factors for immune checkpoint inhibitor (CPI) response in gynecologic cancer are limited. This retrospective study aimed to identify prognostic factors associated with improved overall response rate (ORR) and progression free survival (PFS) in gynecologic cancer patients receiving at least two cycles of CPI. PFS was compared by univariate cox regressions. Univariate and multivariable analyses were used for prognostic factors of PFS and ORR. 72 patients were identified (20 ovarian, 36 endometrial, 13 cervix, 1 vaginal, 2 others). Immune related adverse events (IRAE) occurred in 40.3% of patients (29/72). IRAE was associated with higher ORR (44.8% IRAE vs 20.9% no IRAE, OR 3.1, p = 0.024), improved PFS (12.9 m IRAE vs 4.7 m no IRAE, HR 0.43, p = 0.004) and improved OS (22.9 m IRAE vs 12.2 m no IRAE, HR 0.47, p = 0.021). Additionally, Clear cell histology had superior ORR compared to MSI stable endometrial and ovarian cancers (ORR 57.1% vs 11.8%, OR 10.0, p = 0.032). Responders more often had ARIDIA mutation, PI3K/PTEN alteration and less often had a P53 mutation. In a subset of six MSI-H, recurrent, chemo-naive endometrial cancer ORR was 83.3%. Overall, we found favorable outcomes after CPI for clear cell tumors and patients who developed IRAE. Additionally, first-line systemic therapy with CPI in recurrent MSI-H endometrial cancer had encouraging ORR with durable responses.

Retracted articles in the obstetrics literature: lessons from the past to change the future.

BACKGROUND: The publication of invalid scientific findings may have profound implications on medical practice. As the incidence of article retractions has increased over the last 2 decades, organizations have formed, including Retraction Watch, to improve the transparency of scientific publishing. At present, the incidence of article retraction in the obstetrics and maternal-fetal medicine literature is unclear. OBJECTIVE: This study aimed to determine the number of retracted articles within the obstetrics and maternal-fetal medicine literature from the PubMed and Retraction Watch databases and examine reasons for retraction. STUDY DESIGN: A retrospective review of the PubMed and Retraction Watch databases was performed to identify retracted articles in the obstetrics and maternal-fetal medicine literature from indexation through December 31, 2019. The primary outcome was defined as the number of identified articles and reason for retraction. Within PubMed, articles were identified using a medical subheading search for articles categorized as withdrawn or retracted. In addition, the Retraction Watch database was queried and nonobstetrical articles were excluded. The reason for retraction was classified according to the categories listed in Retraction Watch. The subject matter was classified on the basis of the Society for Maternal-Fetal Medicine criteria. Data were collected from retracted articles for author name, country, journal name and impact factor, year of publication and retraction, study type, and response of the publishing journal. Descriptive statistics were performed. RESULTS: Of the 519 obstetrics and gynecology articles in Retraction Watch, 122 (23.5%) were specific to the obstetrics and maternal-fetal medicine specialties. In addition, 39 (32.0%) were identified from PubMed, all of which were included in Retraction Watch. There was a median time to retraction of 1 (range, 0-17) year, with a median of 3 citations per article (range, 0-145). In addition, the median journal impact factor was 2.2 (range, 0.1-27.6), with median first and senior author Hirsch index values of 6.0 and 13.5, respectively. Most articles were original research (n=80; 65.6%), specifically retrospective studies (n=11; 9.0%), case reports (n=19; 15.6%), prospective studies (n=18; 14.8%), randomized controlled trials (n=11; 9%), basic science (n=18; 14.8%), and systematic review or meta-analysis (n=3; 2.5%). Of eligible articles, 32 (26.2%) were published in journals with an impact factor ≥4, and 21 articles (17.2%) were published in the top 10 leading impact factor obstetrics and gynecology journals. Most retractions were for content-related issues (n=87; 71.3%), including 21.3% (n=26) for article duplication, 18.9% (n=23) for plagiarism, and 16.4% (n=20) for errors in results or methods. Additional reasons included author misconduct (n=12; 9.8%), nonreproducible results (n=11; 9.0%), and falsification (n=8; 6.6%). The most common journal response was an issued statement of retraction (n=82; 67.2%). Lack of retraction notice and limited to no information provided by the publishing journal occurred in 19 retracted articles (15.6%). CONCLUSION: In the obstetrics and maternal-fetal medicine literature, retraction of scientific articles is increasing and is most often related to scientific misconduct, including article duplication and plagiarism. Improved prevention and detection are warranted by journals and healthcare institutions to ensure that invalid findings are not perpetuated in the medical literature, thereby avoiding adverse consequences for maternal and perinatal care.

Reducing abdominal hysterectomy surgical site infections: A multidisciplinary quality initiative.

BACKGROUND: To investigate abdominal hysterectomy surgical site infection (SSI) rates before and after implementation of an SSI care bundle. METHODS: An SSI bundle for abdominal hysterectomies was introduced in our hospital in April 2014 to reduce the SSI rate. The practices were divided into bundle elements around preoperative, intraoperative, and postoperative care. We conducted a retrospective cohort study around implementation of the SSI care bundle. Women were included if they underwent abdominal hysterectomy between 2012 and 2015. They were then divided into 2 study groups: prebundle and postbundle. The primary study outcome was SSI rate. The superficial SSI rate was the secondary outcome. RESULTS: The overall SSI rate was 6.18% in the prebundle group, with a median monthly SSI rate of 7.03%. After bundle implementation, the overall SSI rate declined to 2.51% (P = .02). The reduction remained significant after multivariate analysis (adjusted odds ratio 0.38; 95% confidence interval 0.15-0.88; P = .03) indicating a 62% reduction in SSI postbundle as compared to prebundle.When comparing rates based on infection classification, superficial SSIs declined significantly from 3.73% in the prebundle group to 0.90% in the postbundle group (P = 0.02). Patient demographics and pre-existing medical conditions were similar pre- and postbundle. Compliance with bundle elements was high. CONCLUSIONS: A significant reduction in SSI rate in abdominal hysterectomies was seen following implementation of an infection prevention bundle.

Reflectance-based determination of optical properties in highly attenuating tissue.

Accurate data on in vivo tissue optical properties in the ultraviolet A (UVA) to visible (VIS) range are needed to elucidate light propagation effects and to aid in identifying safe exposure limits for biomedical optical spectroscopy. We have performed a preliminary study toward the development of a diffuse reflectance system with maximum fiber separation distance of less than 2.5 mm. The ultimate objective is to perform endoscopic measurement of optical properties in the UVA to VIS. Optical property sets with uniformly and randomly distributed values were developed within the range of interest: absorption coefficients from 1 to 25 cm(-1) and reduced scattering coefficients from 5 to 25 cm(-1). Reflectance datasets were generated by direct measurement of Intralipid-dye tissue phantoms at lambda=675 nm and Monte Carlo simulation of light propagation. Multivariate calibration models were generated using feed-forward artificial neural network or partial least squares algorithms. Models were calibrated and evaluated using simulated or measured reflectance datasets. The most accurate models developed-those based on a neural network and uniform optical property intervals-were able to determine absorption and reduced scattering coefficients with root mean square errors of +/-2 and +/-3 cm(-1), respectively. Measurements of ex vivo bovine liver at 543 and 633 nm were within 5 to 30% of values reported in the literature. While our technique for determination of optical properties appears feasible and moderately accurate, enhanced accuracy may be achieved through modification of the experimental system and processing algorithms.