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ObjectiveDespite increased participation of women in academic medicine in recent decades, gender disparities persist. The gender gap in authorship and editorial boards in gynecologic oncology, and impact of the COVID-19 pandemic, have not been recently evaluated. We examined gender representation and the impact of COVID-19 on authorship and editorial boards of two major peer-reviewed gynecologic oncology journals.MethodsWe conducted a bibliometric analysis of original articles published in Gynecologic Oncology and the International Journal of Gynecological Cancer, comparing the most contemporary 5-year period (2016–2020) to single years in the two prior decades (1996, 2006). To assess the early impact of COVID-19, we compared publications from May 2020–April 2021 to 2019. Editorial boards were analyzed for gender composition. First names, pronouns, and institutional photographs were used to determine gender.ResultsThere were 3022 original articles published between 2016 and 2020, 763 in 2006, and 203 in 1996. Gender was identified for 91.3% of first authors (3641 articles) and 95.6% of senior authors (3813 articles). Men comprised the majority of the editorial boards in 2021 at 57% and 61% for Gynecologic Oncology and the International Journal of Gynecological Cancer, respectively. Men were overrepresented as senior authors across all study periods: 93% in 1996, 77% in 2006, and 58% in 2016–2020. Over time, representation of women as first and senior authors increased (7% in 1996, 42% in 2016–2020, p<0.00001). There was no immediate impact of the early pandemic on gender distribution of authorship.ConclusionsDespite greater representation of women over time as authors in gynecologic oncology journals, there remains gender disparity in senior authorship and editorial board representation. This presents an opportunity for the academic publishing community to advocate for deliberate strategies to achieve gender parity. Although no impact of the early COVID-19 pandemic was found, this requires ongoing surveillance.

It is unclear whether participation in a randomized controlled trial (RCT), irrespective of assigned treatment, is harmful or beneficial to participants. We compared outcomes for patients with the same diagnoses who did (\"insiders\") and did not (\"outsiders\") enter RCTs, without regard to the specific therapies received for their respective diagnoses. By searching the MEDLINE (1966-2010), Embase (1980-2010), CENTRAL (1960-2010) and PsycINFO (1880-2010) databases, we identified 147 studies that reported the health outcomes of \"insiders\" and a group of parallel or consecutive \"outsiders\" within the same time period. We prepared a narrative review and, as appropriate, meta-analyses of patients' outcomes. We found no clinically or statistically significant differences in outcomes between \"insiders\" and \"outsiders\" in the 23 studies in which the experimental intervention was ineffective (standard mean difference in continuous outcomes -0.03, 95% confidence interval [CI] -0.1 to 0.04) or in the 7 studies in which the experimental intervention was effective and was received by both \"insiders\" and \"outsiders\" (mean difference 0.04, 95% CI -0.04 to 0.13). However, in 9 studies in which an effective intervention was received only by \"insiders,\" the \"outsiders\" experienced significantly worse health outcomes (mean difference -0.36, 95% CI -0.61 to -0.12). We found no evidence to support clinically important overall harm or benefit arising from participation in RCTs. This conclusion refutes earlier claims that trial participants are at increased risk of harm.

A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Study recruitment and follow-up are completed, and analysis of the study results is underway. This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569

A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant's group assignment. Patients in the intervention arm learn to use a Health Canada-approved cellular modem-enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Study recruitment and follow-up are completed, and analysis of the study results is underway. This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569. DERR1-10.2196/72672.

To present a Canadian economic evaluation on the cost-utility of ulipristal acetate (5 mg orally daily) compared to leuprolide acetate (3.75 mg intramuscular monthly) in the treatment of moderate-to-severe symptoms of uterine fibroids in women eligible for surgery. A probabilistic decision tree was constructed to model the pre-operative pharmacological management of uterine fibroids under the primary perspective of the Ontario public payer. The model parameterized data from clinical trials, observational studies, and public costing databases. The outcome measure was the incremental cost-utility ratio. Uncertainty in the model was explored through sensitivity and scenario analyses. Ulipristal was associated with faster control of excessive menstrual bleeding, fewer symptoms of hot flashes and lower health care resource consumption. The ulipristal strategy dominated leuprolide as it provided patients with more quality-adjusted life years (0.177 versus 0.165) at a lower cost ($1,273 versus $1,366). Across a range of sensitivity analyses, the results remained robust except to the dose of the comparator drug. If leuprolide was administered at 11.25 mg, once every 3 months, the expected cost for the leuprolide strategy would decline and the associated incremental cost-utility ratio for ulipristal would be $168/quality-adjusted life year. Ulipristal offers a unique opportunity to effectively and rapidly control menstrual bleeding in patients with uterine fibroids; thereby improving their quality of life while minimizing the probability of moderate-to-severe hot flashes that are common with leuprolide. The current economic analysis suggests that ulipristal remains the dominant strategy across extensive sensitivity analyses.

ObjectiveTo examine the performance of the Risk of Malignancy Index (RMI) and Risk of Ovarian Malignancy Algorithm (ROMA) by histologic subtype and stage of disease in a cohort of women with ovarian cancer.MethodsAll patients with confirmed ovarian cancer at the Princess Margaret Hospital between February 2011 and January 2013 were eligible for study inclusion. Preoperative cancer antigen 125, human epididymis protein 4, and ultrasound findings were reviewed, and the sensitivity and false-negative rates of the RMI and ROMA were determined by stage of disease and tumor histology.ResultsA total of 131 patients with ovarian cancer were identified. High-grade serous (HGS) histology was most frequently associated with stage III/IV disease (n = 46 [72% of stage III/IV]) vs stage I (n = 5 [11% of stage I]; P < 0.0001). Clear cell (CC) and endometrioid (EC) histology presented most commonly with stage I disease (n = 9 [20%] and n = 13 [29% of stage I cases], respectively). Median cancer antigen 125 and human epididymis protein 4 values were significantly higher for HGS than for EC or CC histology. Risk of Malignancy Index II demonstrated the highest sensitivity of the 3 RMI algorithms. All RMIs and ROMA were significantly more sensitive in predicting malignancy in patients with HGS than EC or CC histology. Risk of Malignancy Index II (n = 38) and ROMA (n = 35) exhibited sensitivities of 68% and 54% and false-negative rates of 32% and 46%, respectively, for patients with stage I disease vs sensitivities of 94% and 93% and false-negative rates of 6% and 7% for patients with stage III/IV disease.ConclusionBoth RMI and ROMA performed well for the detection of advanced ovarian cancer and HGS histology. These triaging algorithms do not perform well in patients with stage I disease where EC and CC histologies predominate. Clinicians should be cautious using RMI or ROMA scoring tools to triage isolated adnexal masses because many patients with stage I malignancies would be missed.

ObjectivesPatients with low-risk gestational trophoblastic neoplasia (GTN) are almost universally cured with chemotherapy, but second uterine curettage has been explored as an alternative to avoid chemotherapy-related toxicities. We systematically reviewed intervention studies to determine whether second curettage in patients with low-risk GTN affects: 1) the proportion of patients requiring chemotherapy; 2) the number of chemotherapy cycles; and 3) the need for multi-agent chemotherapy.MethodsA literature search was performed including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and Web of Science. Two authors screened titles, abstracts, and full texts and abstracted data. Risk of bias was assessed for each outcome. Data were pooled using a random-effects model and assessed for heterogeneity. Quality of evidence was assigned using GRADE.ResultsSix studies met inclusion criteria; 2 randomized studies (RCT) and 4 non-randomized studies (NRS). Mean difference in number of chemotherapy cycles was 2.04 fewer in patients who underwent second curettage (95% CI -5.00 to 0.91) based on two pooled RCTs (N=138). Those who underwent second curettage had RR=0.60 (95% CI 0.31 to 1.18) for requiring chemotherapy based on 4 pooled NRS (N=1105), and RR=1.17 (95% CI 0.76 to 1.80) for multi-agent chemotherapy based on two pooled NRS (N=900). The certainty of evidence is very low due to risk of bias for potential confounding, selection bias, missing data, and inconsistency of the results.ConclusionsSecond curettage may reduce the need for chemotherapy in patients with low-risk gestational trophoblastic neoplasia but the evidence is very uncertain.

Introduction/BackgroundPatients with low-risk gestational trophoblastic neoplasia (GTN) are almost universally cured with chemotherapy, but second uterine curettage has been explored as an alternative to avoid chemotherapy-related toxicities. We systematically reviewed intervention studies to determine whether second curettage in patients with low-risk GTN affects: 1) the proportion of patients requiring chemotherapy; 2) the number of chemotherapy cycles; and 3) the need for multi-agent chemotherapy.MethodologyA literature search was performed including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and Web of Science. Two authors screened titles, abstracts, and full texts and abstracted data. Risk of bias was assessed for each outcome. Data were pooled using a random-effects model and assessed for heterogeneity. Quality of evidence was assigned using GRADE.ResultsSix studies met inclusion criteria; 2 randomized studies (RCT) and 4 cohort studies with control arm (CS). Mean difference in number of chemotherapy cycles was 2.04 fewer in patients who underwent second curettage (95% CI -5.00 to 0.91) based on two pooled RCTs (N=138). Those who underwent second curettage had RR=0.60 (95% CI 0.31 to 1.18) for requiring chemotherapy based on 4 pooled CS (N=1105), and RR=1.17 (95% CI 0.76 to 1.80) for multi-agent chemotherapy based on two pooled CS (N=900). The certainty of evidence is very low due to risk of bias for potential confounding, selection bias, missing data, and inconsistency of the results.Abstract 2022-RA-745-ESGO Figure 1Abstract 2022-RA-745-ESGO Figure 2ConclusionIn patients with low-risk GTN, second curettage may increase the proportion cured without chemotherapy, with a trend toward decreasing the number of chemotherapy cycles required, without increasing the risk of requiring alternative chemotherapy. Prospective randomized trials including measurement of safety and fertility data are warranted as the quality of evidence in this review was low.

ObjectivesBackground: GOG-240 demonstrated improved oncologic outcomes with addition of bevacizumab to standard chemotherapy for metastatic or recurrent cervical carcinoma. Previously, JCOG0505 revealed non-inferior oncologic outcomes of carboplatin/paclitaxel(TC) compared to cisplatin/paclitaxel(TP). However, there is no recent data comparing adverse events and chemotherapy response rates between TC and TP since addition of bevacizumab. Objective: To compare adverse events and response to chemotherapy of patients with metastatic or recurrent non-resectable cervical carcinoma who initiated chemotherapy between 01/2015 and 09/2021 with carboplatin/paclitaxel/bevacizumab(TCB) or cisplatin/paclitaxel/bevacizumab(TPB).MethodsA retrospective study was conducted. Adverse events were classified using the National Cancer Institute Common Terminology Criteria for Adverse Events.ResultsForty-seven patients were included; 29 with squamous cell histology and 18 with adenocarcinoma or adenosquamous histology. Median follow-up was 19 months. Thirty-eight patients received TCB, 9 received TPB; 19 were treated for metastatic disease, 3 for persistent disease, and 26 for recurrent disease. Median number of chemotherapy cycles was 6. While response to chemotherapy was similar in both groups (stable disease 13.2% vs 33.3%, p=0.15, partial or complete response, 36.8% vs 33.3%, p=0.84), patients receiving TCB experienced significantly less grade 3–5 (26.3% vs 66.7%, p=0.02) and grade 1–2 adverse events (13.2% vs 55.6%, p=0.005). Bevaziumab was discontinued in 12 patients (25.5%) due to severe toxicity, with significantly greater rate of fistula and perforation compared to rates in GOG 240 (12.8% vs 3%, p=0.004).ConclusionsIn this cohort, patients receiving TCB had similar response to chemotherapy, but significantly less adverse events, than those receiving TPB. Bevacizumab confers a high risk of severe adverse events.