Risk factor analysis of medical litigation outcomes in obstetrics and gynecology: A retrospective cohort study of 344 claims in Japan.

AIM: Medical errors are critical in obstetrics and gynecology (OB/GYN) and contribute to high litigation risks. However, few studies have examined system and diagnostic errors as potential preventable problems. This study aimed to enhance medical safety and reduce litigation by identifying and addressing key contributory factors. METHODS: We retrospectively searched the national Japanese malpractice claims database for OB/GYN cases between 1961 and 2017. We evaluated provider characteristics and background information of the patients (plaintiffs). The main outcome was litigation (acceptance or rejection) in the final judgment. Using multivariable logistic regression models, we assessed the associations between medical malpractice variables (system and diagnostic errors, facility size, situation, place, time, and clinical outcomes) and litigation outcomes (acceptance). RESULTS: Overall, 344 malpractice claims were analyzed. Among these, 277 (80.5 %) were obstetric, and 67 (19.5 %) were gynecological. Of the obstetric cases, 193 were perinatal, and 84 were maternal. Malpractice claims were accepted (OB-GYN losses) in 185 cases (53.8 %). In multivariable analyses, system errors (odds ratio 97.4, 95 % confidence interval 35.2-270.0), diagnostic errors (odds ratio 4.5, 95 % confidence interval 1.8-11.3), and clinic (odds ratio 2.7, 95 % confidence interval 1.2-4.8) had a significant statistical association with accepted claims. CONCLUSION: System errors, diagnostic errors, and clinics were significantly associated with acceptance claims. These findings underscore the necessity of addressing modifiable factors at the physician level and within the healthcare management system to enhance patient safety and reduce litigation risks, thereby ensuring a safer and more reliable healthcare environment for patients and medical professionals.

Comparison of Postoperative outcomes Among Patients Treated by Male Versus Female Surgeons: A Systematic Review and Meta-analysis.

OBJECTIVE: To compare clinical outcomes of patients treated by female surgeons versus those treated by male surgeons. SUMMARY BACKGROUND DATA: It remains unclear as to whether surgical performance and outcomes differ between female and male surgeons. METHODS: We conducted a meta-analysis to compare patients' clinical outcomes-including patients' postoperative mortality, readmission, and complication rates-between female versus male surgeons. MEDLINE, Embase, CENTRAL, ICTRP, and ClinicalTrials.gov were searched from inception to September 8, 2022. The update search was conducted on July 19, 2023. We used random-effects models to synthesize data and GRADE to evaluate the certainty. RESULTS: A total of 15 retrospective cohort studies provided data on 5,448,121 participants. We found that patients treated by female surgeons experienced a lower post-operative mortality compared with patients treated by male surgeons (8 studies; adjusted odds ratio [aOR], 0.93; 95%CI, 0.88 - 0.97; I2=27%; moderate certainty of the evidence). We found a similar pattern for both elective and non-elective (emergent or urgent) surgeries, although the difference was larger for elective surgeries (test for subgroup difference P=0.003). We found no evidence that female and male surgeons differed for patient readmission (3 studies; aOR, 1.20; 95%CI, 0.83 - 1.74; I2=92%; very low certainty of the evidence) or complication rates (8 studies; aOR, 0.94; 95%CI, 0.88 - 1.01: I2=38%; very low certainty of the evidence). CONCLUSIONS: This systematic review and meta-analysis suggests that patients treated by female surgeons have a lower mortality compared with those treated by male surgeons.

Poor Prognosis in Low-Grade Endometrial Stromal Sarcoma With Cyclin-Dependent Kinase Inhibitor 2A Homozygous Deletion: A Case Study.

Low-grade endometrial stromal sarcoma (LGESS) typically has a favorable prognosis. Hormone therapy is considered the first choice of treatment for recurrent LGESS. In this report, we describe a case of recurrent LGESS where hormone therapy was ineffective, chemotherapy showed a partial response (PR), and pazopanib resulted in stable disease (SD). A 50-year-old patient with LGESS underwent a simple total hysterectomy and bilateral adnexectomy (pT1aN0M0, stage IA). Five years later, pelvic tumors and ascites were observed. Exploratory laparoscopy revealed bloody ascites, an 8 cm pelvic tumor, and extensive peritoneal dissemination. Nuclear atypia of the tumor cells was mild, pleomorphism and mitotic figures could not be confirmed, and necrosis was not observed. Immunostaining was positive for CD10 and estrogen receptor, negative for the BCL6 corepressor (BCOR), and showed a low Ki-67 index. Fluorescence in situ hybridization (FISH) examination of the tissue showed rearrangement of the JAZF zinc finger 1 (JAZF1) gene. Multigene panel testing revealed a homozygous deletion of cyclin-dependent kinase inhibitor 2A (CDKN2A). Accordingly, the patient was diagnosed with recurrent LGESS and was treated with an aromatase inhibitor, followed by medroxyprogesterone acetate; both were ineffective. The patient had a PR to chemotherapy (doxorubicin/ifosfamide) and SD to pazopanib. The patient died 1.5 years after recurrence. In conclusion, we present a case of LGESS with a poor prognosis where hormone therapy was ineffective, and chemotherapy and pazopanib were both partially effective. The poor prognosis may have been associated with the CDKN2A homozygous deletion.

Efficacy and Safety of the Surgery-First Approach Compared to the Chemotherapy-First Approach for Treating Low-Risk Gestational Trophoblastic Neoplasia: A Systematic Review and Meta-Analysis.

For gestational trophoblastic neoplasia (GTN) affecting women of reproductive age, the chemotherapy-first approach is often preferred over the surgery-first approach. Low-risk GTN is treated with a chemotherapy-first approach, but the number of courses required can affect fertility. A surgery-first approach may decrease the number of chemotherapy courses, but its efficacy and safety compared to a chemotherapy-first approach are unclear. Thus, we investigated the efficacy and safety of the surgery-first approach compared to the chemotherapy-first approach in treating low-risk GTN. We searched the MEDLINE, Embase, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform databases for relevant articles in July 2023. A systematic review and meta-analysis of outcome measures were conducted using a random-effects model. The primary outcomes were remission, the mean number of chemotherapy courses required to cure, and adverse events. The certainty of the evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. This study protocol was registered in the Open Science Framework (https://osf.io/kysvn/). Studies for low-risk GTN included a qualitative synthesis (with 2,192 participants and ten studies, eight of which were about second uterine curettage and two about hysterectomy) and a meta-analysis (with 138 participants and two randomized controlled trials (RCTs) that compared first-line treatments of second uterine curettage and chemotherapy). Second uterine curettage may result in little to no difference in remission (risk ratio: 1.00, 95% confidence interval: 0.96-1.05; low certainty) and a slight reduction in adverse events (risk ratio: 0.87, 95% confidence interval: 0.47-1.60; low certainty). The evidence is very uncertain on the mean number of chemotherapy courses (mean difference: 2.84 lower, 95% confidence interval: 7.31 lower to 1.63 higher; very low certainty). Based on clinical outcomes, second uterine curettage can be comparable to the chemotherapy-first approach as a first-line treatment option for low-risk GTN; however, the overall certainty of the evidence was low or very low.

Resuscitative endovascular balloon occlusion of the aorta for life-threatening postpartum hemorrhage: A nationwide observational study in Japan.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used for postpartum hemorrhage (PPH), which is one of the leading causes of maternal mortality worldwide; however, its utility in the obstetrics setting remains unclear. Thus, this study aimed to describe the characteristics, demographics, and mortality of patients with PPH who underwent REBOA. METHODS: We used the Japanese Diagnosis Procedure Combination inpatient database to identify patients with PPH who underwent REBOA from April 2012 to March 2020. We examined the patients' characteristics, interventions administered, and in-hospital mortality. RESULTS: We identified 143 patients with PPH who underwent REBOA. The most common cause of PPH was atonic postpartum hemorrhage (52.4%), followed by disseminated intravascular coagulation (29.4%) and amniotic fluid embolism documented (11.2%). Among patients who delivered at hospitals in which REBOA was performed (n = 55), 38.2% of patients experienced preterm births, and 70.9% delivered via cesarean delivery. The proportion of patients who underwent transcatheter arterial embolization and hysterectomy was 53.8% and 16.1%, respectively. In-hospital mortality was 7.0%. CONCLUSION: The results of the present study could be helpful in clinical decision making and providing patients and families with additional treatment options for PPH. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Pyosalpinx due to Cronobacter sakazakii in an elderly woman.

BACKGROUND: Cronobacter sakazakii (C. sakazakii) is a bacterium known to cause severe neonatal infections in premature infants with the consumption of contaminated powdered milk formula. Adult infections are rare, and there have been no reports of pyosalpinx due to C. sakazakii to date. CASE PRESENTATION: We report a case of left pyosalpinx due to C. sakazakii in a sexually inactive postmenopausal woman. A 70-year-old woman presented to our hospital with left lower abdominal pain and fever. Abdominal computed tomography disclosed a cystic mass continuous with the left edge of the uterus. Urgent laparotomy revealed a ruptured left pyosalpinx with pus-like content. Left salpingo-oophorectomy, resection of the right tube, and washing of the abdominal cavity with saline were performed. Pathological examination of the left adnexa showed tubal tissue with acute inflammation and inflammatory exudate, which were compatible with pyosalpinx, and pus culture yielded C. sakazakii. CONCLUSIONS: This is the first case report of pyosalpinx due to C. sakazakii. Cronobacter sakazakii infections in adult women might occur in the elderly, whose immunity has weakened. Further accumulation of cases of C. sakazakii infection is needed to clarify the etiology and behavior of C. sakazakii in adults.

Association between the number of pulls and adverse neonatal/maternal outcomes in vacuum-assisted delivery.

OBJECTIVES: To determine the association between the number of pulls during vacuum-assisted deliver and neonatal and maternal complications. METHODS: This was a single-center observational study using a cohort of pregnancies who underwent vacuum-assisted delivery from 2013 to 2020. We excluded pregnancies transitioning to cesarean section after a failed attempt at vacuum-assisted delivery. The number of pulls to deliver the neonate was categorized into 1, 2, 3, and ≥4 pulls. We used logistic regression models to investigate the association between the number of pulls and neonatal intensive care unit (NICU) admission and maternal composite outcome (severe perineal laceration, cervical laceration, transfusion, and postpartum hemorrhage ≥500 mL). RESULTS: We extracted 480 vacuum-assisted deliveries among 7,321 vaginal deliveries. The proportion of pregnancies receiving 1, 2, 3, or ≥4 pulls were 51.9, 28.3, 10.8, and 9.0%, respectively. The crude prevalence of NICU admission with 1, 2, 3, and ≥4 pulls were 10.8, 16.2, 15.4, and 27.9%, respectively. The prevalence of NICU admission, amount of postpartum hemorrhage, and postpartum hemorrhage ≥500 mL were significantly different between the four groups. Multivariable logistic regression analysis found the prevalence of NICU admission in the ≥4 pulls group was significantly higher compared with the 1 pull group (adjusted odds ratio, 3.3; 95% confidence interval, 1.4-7.8). In contrast, maternal complications were not significantly associated with the number of pulls. CONCLUSIONS: Vacuum-assisted delivery with four or more pulls was significantly associated with an increased risk of NICU admission. However, the number of pulls was not associated with maternal complications.