An absence of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants.

OBJECTIVES: A lack of diversity amongst participants in cancer clinical trials has raised scrutiny over the past decade. Patients with limited English proficiency (LEP) are further excluded. One modifiable reason for low LEP participation is a lack of non-English consent forms. METHODS: We queried the clinical trials registry database at an academic hospital serving a predominantly Spanish-speaking patient population. Clinical trials related to gynecology oncology were evaluated for the availability of fully translated Spanish consent forms, the racial and ethnic identification of enrolled patients, and the number of signed Spanish consents. Enrolment data was compared before and after 2019, when institutional financial support for document translation was withdrawn. RESULTS: Sixteen gynecologic oncology clinical trials were opened between 2014 and 2022, with 10 trials enrolling 128 patients. Eight trials opened prior to 2019, all with fully translated consent forms. Seven of these trials enrolled 99 participants, 70% of whom identified as Hispanic and 60% who signed a Spanish consent. Eight trials opened after 2019 and one had a fully translated consent form. Three of the trials enrolled 29 participants, with 10% of subjects identifying as Hispanic and none signing a Spanish consent form. CONCLUSIONS: There was a decrease in fully translated clinical trial consent forms for gynecologic oncology studies following the loss of subsidized translation services in our single institution with a predominantly LEP population. This correlated with a decrease in enrollment of Hispanic subjects. To increase enrollment of diverse participants, including those with LEP, simple actions such as fully translating consent forms would help maintain equity in research conduct and improve clinical outcomes through trial involvement.

Cesarean hysterectomy for placenta accreta spectrum: Surgeon specialty-specific assessment.

OBJECTIVE: To assess (i) clinical and pregnancy characteristics, (ii) patterns of surgical procedures, and (iii) surgical morbidity associated with cesarean hysterectomy for placenta accreta spectrum based on the specialty of the attending surgeon. METHODS: The Premier Healthcare Database was queried retrospectively to study patients with placenta accreta spectrum who underwent cesarean delivery and concurrent hysterectomy from 2016 to 2020. Surgical morbidity was assessed with propensity score inverse probability of treatment weighting based on surgeon specialty for hysterectomy: general obstetrician-gynecologists, maternal-fetal medicine specialists, and gynecologic oncologists. RESULTS: A total of 2240 cesarean hysterectomies were studies. The most common surgeon type was general obstetrician-gynecologist (n = 1534, 68.5%), followed by gynecologic oncologist (n = 532, 23.8%) and maternal-fetal medicine specialist (n = 174, 7.8%). Patients in the gynecologic oncologist group had the highest rate of placenta increta or percreta, followed by the maternal-fetal medicine specialist and general obstetrician-gynecologist groups (43.4%, 39.6%, and 30.6%, P < .001). In a propensity score-weighted model, measured surgical morbidity was similar across the three subspecialty groups, including hemorrhage / blood transfusion (59.4-63.7%), bladder injury (18.3-24.0%), ureteral injury (2.2-4.3%), shock (8.6-10.5%), and coagulopathy (3.3-7.4%) (all, P > .05). Among the cesarean hysterectomy performed by gynecologic oncologist, hemorrhage / transfusion rates remained substantial despite additional surgical procedures: tranexamic acid / ureteral stent (60.4%), tranexamic acid / endo-arterial procedure (76.2%), ureteral stent / endo-arterial procedure (51.6%), and all three procedures (55.4%). Tranexamic acid administration with ureteral stent placement was associated with decreased bladder injury (12.8% vs 23.8-32.2%, P < .001). CONCLUSION: These data suggest that patient characteristics and surgical procedures related to cesarean hysterectomy for placenta accreta spectrum differ based on surgeon specialty. Gynecologic oncologists appear to manage more severe forms of placenta accreta spectrum. Regardless of surgeon's specialty, surgical morbidity of cesarean hysterectomy for placenta accreta spectrum is significant.

Racial and ethnic differences in early death among gynecologic malignancy.

BACKGROUND: Racial and ethnic differences in early death after cancer diagnosis have not been well studied in gynecologic malignancy. OBJECTIVE: This study aimed to assess population-level trends and characteristics of early death among patients with gynecologic malignancy based on race and ethnicity in the United States. STUDY DESIGN: The National Cancer Institute's Surveillance, Epidemiology, and End Results Program was queried to examine 461,300 patients with gynecologic malignancies from 2000 to 2020, including uterine (n=242,709), tubo-ovarian (n=119,989), cervical (n=68,768), vulvar (n=22,991), and vaginal (n=6843) cancers. Early death, defined as a mortality event within 2 months of the index cancer diagnosis, was evaluated per race and ethnicity. RESULTS: At the cohort level, early death occurred in 21,569 patients (4.7%), including 10.5%, 5.5%, 2.9%, 2.5%, and 2.4% for tubo-ovarian, vaginal, cervical, uterine, and vulvar cancers, respectively (P<.001). In a race- and ethnicity-specific analysis, non-Hispanic Black patients with tubo-ovarian cancer had the highest early death rate (14.5%). Early death racial and ethnic differences were the largest in tubo-ovarian cancer (6.4% for Asian vs 14.5% for non-Hispanic Black), followed by uterine (1.6% for Asian vs 4.9% for non-Hispanic Black) and cervical (1.8% for Hispanic vs 3.8% to non-Hispanic Black) cancers (all, P<.001). In tubo-ovarian cancer, the early death rate decreased over time by 33% in non-Hispanic Black patients from 17.4% to 11.8% (adjusted odds ratio, 0.67; 95% confidence interval, 0.53-0.85) and 23% in non-Hispanic White patients from 12.3% to 9.5% (adjusted odds ratio, 0.77; 95% confidence interval, 0.71-0.85), respectively. The early death between-group difference diminished only modestly (12.3% vs 17.4% for 2000-2002 [adjusted odds ratio for non-Hispanic White vs non-Hispanic Black, 0.54; 95% confidence interval, 0.45-0.65] and 9.5% vs 11.8% for 2018-2020 [adjusted odds ratio, 0.65; 95% confidence interval, 0.54-0.78]). CONCLUSION: Overall, approximately 5% of patients with gynecologic malignancy died within the first 2 months from cancer diagnosis, and the early death rate exceeded 10% in non-Hispanic Black individuals with tubo-ovarian cancer. Although improving early death rates is encouraging, the difference among racial and ethnic groups remains significant, calling for further evaluation.

Temporal trends of failure-to-rescue following perioperative complications in vulvar cancer surgery in the United States.

OBJECTIVE: Failure-to-rescue, defined as mortality following a perioperative complication, is a perioperative quality indicator studied in various surgeries, but not in vulvar cancer surgery. The objective of this study was to assess failure-to-rescue in patients undergoing surgical therapy for vulvar cancer. METHODS: This cross-section study queried the National Inpatient Sample. The study population was 31,077 patients who had surgical therapy for vulvar cancer from 1/2001-9/2015. The main outcomes were (i) perioperative morbidity (29 indicators) and (ii) mortality following a perioperative complication during the index admission for vulvar surgery (failure-to-rescue), assessed with a multivariable binary logistic regression model. RESULTS: The cohort-level median age was 69 years, and 14,337 (46.1%) had medical comorbidity. Perioperative complications were reported in 4736 (15.2%) patients during the hospital admission for vulvar surgery. In multivariable analysis, patient factors including older age, medical comorbidity, and morbid obesity, and treatment factors with prior radiotherapy and radical vulvectomy were associated with perioperative complications (P < 0.05). The number of patients with morbid obesity, higher comorbidity index, and prior radiotherapy increased over time (P-trends < 0.001). Among 4736 patients who developed perioperative complications, 55 patients died during the hospital admission for vulvar surgery (failure-to-rescue rate, 1.2%). In multivariable analysis, cardiac arrest (adjusted-odds ratio [aOR] 27.25), sepsis or systemic inflammatory response syndrome (aOR 11.54), pneumonia (aOR 6.03), shock (aOR 4.37), and respiratory failure (aOR 3.10) were associated with failure-to-rescue (high-risk morbidities). There was an increasing trend of high-risk morbidities from 2.0% to 3.7% over time, but the failure-to-rescue from high-risk morbidities decreased from 9.1% to 2.8% (P-trend < 0.05). CONCLUSION: Vulvar cancer patients undergoing surgical treatment had increased comorbidity over time with an increase in high-risk complications. However, failure-to-rescue rate has decreased significantly.

Uptake in sentinel lymph node biopsy for endometrial cancer with T3 classification.

OBJECTIVE: The current clinical practice guidelines for endometrial cancer specify sentinel lymph node (SLN) biopsy to be performed in apparent uterine-confined disease. However, a recent population-based analysis found that the utilization of SLN biopsy is increasing in extra-uterine disease such as T2 classification. The objective of this study was to examine trends and outcomes related to SLN biopsy for endometrial cancer with T3 classification, another extra-uterine disease. METHODS: A population-based retrospective cohort study was conducted to examine 7004 women with T3 endometrial cancer who underwent primary surgery between 2010 and 2018, identified in the National Cancer Institute's Surveillance, Epidemiology, and End Results Program. Trends and characteristics related to SLN biopsy were assessed by multinomial regression analysis, and inverse probability of treatment weighting propensity score was used to assess overall survival related to SLN biopsy. RESULTS: Nodal evaluation type included lymphadenectomy (n = 5276, 75.3%), SLN biopsy (n = 287, 4.1%), and none (n = 1441, 20.6%). The utilization of SLN biopsy increased from 0.4% to 12.9% between 2010 and 2018 (P < 0.001) that this association remained independent in multivariable analysis (adjusted-odds ratio compared to 2010-2012, 2.63 [95% confidence interval 1.57-4.42] for 2013-2015 and 10.1 [95% confidence interval 6.30-16.2] for 2016-2018). When compared to the lymphadenectomy group, the SLN biopsy group was less likely to have T3b disease (adjusted-odds ratio 0.69, 95% confidence interval 0.51-0.94) but had similar postoperative chemotherapy and radiotherapy (both, P > 0.05). In a weighted model, the 3-year overall survival rate was 66.3% for the SLN biopsy group and 64.7% for the lymphadenectomy group (hazard ratio 0.85, 95% confidence interval 0.69-1.05). Similar association was observed in subcohorts for young, old, endometrioid, non-endometrioid, T3a, T3b, and N0 cases. CONCLUSION: Utilization of SLN biopsy in T3 endometrial cancer is increasing in the United States.

Cesarean hysterectomy for placenta accreta spectrum: 3-2-1 approach.

Given the high risk of complications associated with cesarean hysterectomy for placenta accreta spectrum (PAS), any surgical approach and technique can yield utility in reducing the surgical morbidity. Here, we propose the 3-2-1 approach as a schema to be implemented in the proper setting for the surgical management of a PAS cesarean hysterectomy. The 3-2-1 approach begins with the surgical dissection of three anatomical landmarks that ultimately facilitate a safe surgical site for the ligation and transection of the uterine vessels. First-step is identification of the three anatomical landmarks which are (i) posterior lower uterine segment peritoneum de-serosalization, (ii) identification of the ureters laterally, and (iii) anterior bladder dissection. Posterior-to-anterior progression avoids encountering dense adhesions and hypervascularity in the anterior lower uterine segment early in the surgery. Further, allows better mobilization of the uterus to identify the anatomical landmarks laterally and anteriorly. Second-step is to deploy the 2-hand technique where the surgeon places one hand anteriorly and the other hand posteriorly in the lower uterine segment below the placental bed. The surgeon brings both hands together with flexed fingers perpendicular to the uterine tissue and gently elevates the uterus and placenta out of the pelvis and ensures safe anatomical distance to surrounding structures. Third-step is the consideration of a supracervical hysterectomy. In summary, this 3-2-1 approach to reflect the anatomy of enlarged lower uterine segment in PAS is a stepwise schema that can aid surgeons in the completion of a cesarean hysterectomy, with the goal to improve surgical outcomes.

Assessment of Gender-Specific COVID-19 Case Fatality Risk per Malignant Neoplasm Type.

Importance: While the characteristics of COVID-19 infection and mortality among patients with a malignant neoplasm have previously been examined, little data are available for gender-specific COVID-19 mortality. Objective: To examine the gender-specific COVID-19 case fatality risks among patients with a malignant neoplasm. Design, Setting, and Participants: In this cohort study using the Healthcare Cost and Utilization Project's National Inpatient Sample, patients admitted to the hospital from April to December 2020 with a diagnosis of COVID-19 infection were identified by the World Health Organization's International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code U07.1. Data analysis was performed from November 2022 to January 2023. Exposure: Diagnosis of malignant neoplasm, identified and classified according to the National Cancer Institute's definition. Main Outcome and Measure: COVID-19 in-hospital case fatality rate, defined as the number of deaths that occurred during index hospital admissions. Results: There were 1 622 755 patients who were admitted to the hospital from April 1 to December 31, 2020, with a diagnosis of COVID-19. The cohort-level COVID-19 in-hospital case fatality rate was 12.9% with a median time to death of 5 days (IQR, 2-11 days). Frequently reported morbidities among the patients with COVID-19 included pneumonia (74.3%), respiratory failure (52.9%), cardiac arrythmia or cardiac arrest (29.3%), acute kidney injury (28.0%), sepsis (24.6%), shock (8.6%), cerebrovascular accident (5.2%), and venous thromboembolism or pulmonary embolism (5.0%). In a multivariable analysis, gender (male vs female, 14.5% vs 11.2%; adjusted odds ratio [aOR], 1.28; 95% CI, 1.27-1.30) and malignant neoplasm (17.9% vs 12.7%; aOR, 1.29; 95% CI, 1.27-1.32) were both associated with increased COVID-19 in-hospital case fatality risk at the cohort level. Among the group of female patients, there were 5 malignant neoplasms in which the COVID-19 in-hospital case fatality risk was greater than 2-fold higher. These included anal cancer (23.8%; aOR, 2.94; 95% CI, 1.84-4.69), Hodgkin lymphoma (19.5%; aOR, 2.79; 95% CI, 1.90-4.08), non-Hodgkin lymphoma (22.4%; aOR, 2.23; 95% CI, 2.02-2.47), lung cancer (24.3%; aOR, 2.21; 95% CI, 2.03-2.39), and ovarian cancer (19.4%; aOR, 2.15; 95% CI, 1.79-2.59). Among the group of male patients, Kaposi sarcoma (33.3%; aOR, 2.08; 95% CI, 1.18-3.66) and malignant neoplasm in the small intestine (28.6%; aOR, 2.04; 95% CI, 1.18-3.53) had a greater than 2-fold increased COVID-19 in-hospital case mortality risk. Conclusions and Relevance: The results of this cohort study confirmed the substantial case fatality rate among patients with COVID-19 in the early pandemic experience in 2020 in the US. While COVID-19 in-hospital case fatality risks were lower among women compared with men, the associations of a concurrent malignant neoplasm with the COVID-19 case fatality were overall more substantial for women than for men.

Concurrent Minimally Invasive Gynecologic Procedures at the Time of Laparoscopic Cholecystectomy.

In this cross-sectional study including 1,722,479 women who underwent laparoscopic cholecystectomy between January 2016 and December 2019 identified in the Healthcare Cost and Utilization Project's Nationwide Ambulatory Surgery Sample, the prevalence rate of gynecologic diagnoses was 11.3 per 1,000. Among presumed elective laparoscopic cholecystectomy, the highest performance rate of concurrent gynecologic procedure per gynecologic diagnosis was laparoscopic adnexectomy among patients with benign ovarian tumor (652/1,000 diagnoses), followed by laparoscopic adnexectomy for endometrioma (386/1,000 diagnoses) and cervical conization for cervical carcinoma in situ (304/1,000 diagnoses). The measured surgical morbidity rates for patients who had concurrent gynecologic surgery and those who did not were 2.8 per 1,000 and 1.9 per 1,000, respectively (adjusted odds ratio 1.39, 95% CI 0.75-2.59). These results suggest that minimally invasive gynecologic surgeries are being performed at the time of outpatient laparoscopic cholecystectomy in the United States.

Secondary ovarian cancer after external beam radiotherapy for nonovarian pelvic malignancy.

OBJECTIVE: To examine characteristics and survival of patients who developed secondary ovarian cancer after external beam radiotherapy (EBRT) for a prior nonovarian pelvic malignancy. METHODS: This is a population-based retrospective cohort study, querying the Surveillance, Epidemiology, and End Result program from 1975 to 2016. 167,269 women who received EBRT for 7 malignancies (anus, rectum, bladder, cervix, uterus, vulva, or vagina) were examined to identify subsequent secondary ovarian cancer diagnosis after EBRT. Then, within the ovarian cancer cohort (n = 147,618), characteristics and survival of patients with secondary ovarian cancer after EBRT were compared to those with ovarian cancer who did not receive prior EBRT. RESULTS: Following EBRT for a pelvic malignancy, 215 (1.3 per 1000) patients developed secondary ovarian cancer. Among those, the most frequent prior malignancy was cervical cancer (45.6%), followed by rectal cancer (20.9%). The median time from prior EBRT to secondary ovarian cancer was 8.8 years (interquartile range, 2.8-14.5). In multivariable analysis, patients with secondary ovarian cancer after EBRT were more likely to be older, and have a recent year of diagnosis, but less likely to have early-disease compared to ovarian cancer patients without prior EBRT (all, P < 0.05). In weighted model, patients with secondary ovarian cancer after EBRT had decreased overall survival compared to those with ovarian cancer without prior EBRT (5-year rates, 19.6% versus 39.9%, hazard ratio 1.62, 95% confidence interval 1.43-1.85). Similar association was observed in ages <70, ≥70, White, non-White, early-disease, and advanced-disease in sensitivity analyses. CONCLUSION: Radiotherapy-related secondary ovarian cancer may be associated with decreased overall survival.

Utilization and Outcomes of Sentinel Lymph Node Biopsy for Early Endometrial Cancer.

OBJECTIVE: To examine trends, characteristics, and oncologic outcomes of sentinel lymph node biopsy for early endometrial cancer. METHODS: This observational study queried the National Cancer Institute's Surveillance, Epidemiology, and End Results Program by examining 83,139 women with endometrial cancer who underwent primary hysterectomy with nodal evaluation for T1 disease from 2003 to 2018. Primary outcome measures were the temporal trends in utilization of sentinel lymph node biopsy and patient characteristics associated with sentinel lymph node biopsy use, assessed by multivariable binary logistic regression models. Secondary outcome measure was endometrial cancer-specific mortality associated with sentinel lymph node biopsy, assessed by propensity score inverse probability of treatment weighting. RESULTS: The utilization of sentinel lymph node biopsy increased from 0.2 to 29.7% from 2005 to 2018 (P<.001). The uptake was higher for women with endometrioid (0.3-31.6% between 2005 and 2018) compared with nonendometrioid (0.6-21.0% between 2006 and 2018) histologic subtypes (both P<.001). In a multivariable analysis, more recent year surgery, endometrioid histology, well-differentiated tumors, T1a disease, and smaller tumor size were independently associated with sentinel lymph node biopsy use (P<.05). Performance of sentinel lymph node biopsy was not associated with increased endometrial cancer-specific mortality compared with lymphadenectomy for endometrioid tumors (subdistribution hazard ratio [HR] 0.96, 95% CI 0.82-1.13) or nonendometrioid tumors (subdistribution HR 0.85, 95% CI 0.69-1.04). For low-risk endometrial cancer, the increase in sentinel lymph node biopsy resulted in a 15.3 percentage-point (1.4-fold) increase in surgical nodal evaluation by 2018 (expected vs observed rates, 37.8 vs 53.1%). CONCLUSION: The landscape of surgical nodal evaluation is shifting from lymphadenectomy to sentinel lymph node biopsy for early endometrial cancer in the United States, with no indication of a negative effect on cancer-specific survival.

Retrospective Analysis of Post-Operative Antibiotics in Complicated Appendicitis.

Background: There is no consensus regarding the ideal post-operative antibiotic strategy for surgically managed complicated appendicitis. The goal of this study was to investigate different antibiotic regimens used for this purpose at our institution and their association with post-operative outcomes. Methods: The 1,102 patients underwent appendectomy from 2012 to 2016. A detailed chart review was performed on the 188 with complicated appendicitis based on standardized definitions. Descriptive and inferential statistics were used to analyze post-operative antibiotic use and complications. Results: Of the 188 cases of complicated appendicitis, 143 (76%) were classified as perforated by the operative surgeon. These patients were significantly more likely to be started on antibiotics after appendectomy (83.9% versus 33.3%; p < 0.001) and have a greater length of stay (LOS) (p = 0.006). The development of a surgical site infection (SSI) was significantly associated with a clinical diagnosis of diabetes (p = 0.04); the presence of free fluid, abscess, or perforation on pre-operative imaging (p = 0.002, 0.039, and 0.012, respectively); and a decision by the surgeon to leave a drain (p = 0.001). On multiple logistic regression analysis adjusted for free fluid on pre-operative imaging and an intra-operative decision to leave a drain, patients receiving one day or three or more days of antibiotics had higher odds of developing an SSI than patients who did not receive any post-operative antibiotics. Conclusions: In this cohort, operative surgeons accurately identified patients with complicated appendicitis who did not require post-operative antibiotics. For patients deemed to require them, two days of treatment was associated with reduced odds of SSI compared with shorter or longer antibiotic courses. The optimal course of antibiotics remains to be identified, but these findings suggest that longer post-operative courses do not avert SSI compared with two days of antibiotics. A prospective trial could clarify the optimal duration and route of antibiotic therapy in the setting of surgical complicated appendicitis.