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The Surgical Patient Safety System (SURPASS) has been proven to improve patient outcomes. However, few studies have evaluated the details of litigation and its prevention in terms of systemic and diagnostic errors as potentially preventable problems. The present study explored factors associated with accepted claims (surgeon-loss). We retrospectively searched the national Japanese malpractice claims database between 1961 and 2017. Using multivariable logistic regression models, we assessed the association between medical malpractice variables (systemic and diagnostic errors, facility size, time, place, and clinical outcomes) and litigation outcomes (acceptance). We evaluated whether or not the factors associated with litigation could have been prevented with the SURPASS checklist. We identified 339 malpractice claims made against general surgeons. There were 159 (56.3%) accepted claims, and the median compensation paid was 164,381 USD. In multivariable analyses, system (odds ratio, 27.2 95% confidence interval 13.8-53.5) and diagnostic errors (odds ratio 5.3, 95% confidence interval 2.7-10.5) had a significant statistical association with accepted claims. The SURPASS checklist may have prevented 7% and 10% of the accepted claims and systemic errors, respectively. It is unclear what proportion of accepted claims indicated that general surgeon loses should be prevented from performing surgery if the SURPASS checklist were used. In conclusion, systemic and diagnostic errors were associated with accepted claims. Surgical teams should adhere to the SURPASS checklist to enhance patient safety and reduce surgeon risk.
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Mala Praxis , Errores Médicos , Humanos , Estudios Retrospectivos , Errores Médicos/prevención & control , Japón , Errores Diagnósticos/prevención & controlRESUMEN
In the patients undergoing pelvic organ prolapse (POP) repairs, the incidence of occult uterine endometrial cancer is low and there is no established management procedure for preoperative cancer screening. We report a case of pelvic reconstruction in abdominal trachelectomy and bilateral salpingo-oophorectomy for occult uterine endometrial cancer found in specimens removed in the context of laparoscopic sacrocolpopexy (LSC). A 70-year-old woman presented to our center with cystocele. She underwent LSC and laparoscopic supracervical hysterectomy. She had no atypical genital bleeding; and, transvaginal ultrasound, pelvic plane magnetic resonance imaging and cervical cytology showed no evidence of malignancy. However, the pathological examination showed uterine endometrial cancer. She underwent trachelectomy, bilateral salpingo-oophorectomy and pelvic lymph node dissection. A part of mesh was removed with a cervical stamp, but the remaining mesh was sewn together. At 5 months after the operation, no recurrence of uterine endometrial cancer and POP was seen.
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Neoplasias Endometriales , Laparoscopía , Traquelectomía , Femenino , Humanos , Anciano , Salpingooforectomía , Histerectomía/métodos , Neoplasias Endometriales/cirugía , Laparoscopía/métodosRESUMEN
Placental mesenchymal dysplasia (PMD), characterized by an enlarged and thickened placenta with multiple hypoechoic cystic spaces, frequently leads to a poor infantile/fetal outcome. Here, we describe a case of PMD involving an infant delivered at term with a good outcome. The fetus was male, and the proportion of the PMD lesion to the entire placenta remained constant: the PMD lesion did not enlarge. Given what is known about the pathogenesis of PMD with its association with vascular endothelial growth factor-D (VEGF-D) encoded by an X-linked gene and androgenetic/biparental mosaicism, which is consistent with female dominancy and a poor outcome, we suggest that a male sex of the fetus and non-progressing PMD may have been associated with this good outcome.
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Enfermedades Placentarias/genética , Factor D de Crecimiento Endotelial Vascular/genética , Adulto , Femenino , Desarrollo Fetal/genética , Humanos , Nacimiento Vivo , Masculino , Mosaicismo , Placenta/patología , Enfermedades Placentarias/patología , EmbarazoRESUMEN
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.
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BACKGROUND AND OBJECTIVES: To investigate whether and when the correction is done in Systematic Reviews (SRs) and Clinical Practice Guidelines (CPGs) when included Randomized Controlled Trials (RCTs) have been retracted. METHODS: In this meta-epidemiological study, we included SRs and CPGs citing the retracted RCTs from the Retraction Watch Database. We investigated how often the retracted RCTs were cited in SRs and CPGs. We also investigated whether and when such SRs and CPGs corrected themselves. RESULTS: We identified 587 articles (525 SRs and 62 CPGs) citing retracted RCTs. Among the 587 articles, 252 (43%) were published after retraction, and 335 (57%) were published before retraction. Among 127 articles published citing already retracted RCTs in their evidence synthesis without caution, none corrected themselves after publication. Of 335 articles published before retraction, 239 included RCTs that were later retracted in their evidence synthesis. Among them, only 5% of SRs (9/196) and 5% of CPGs (2/43) corrected or retracted their results. CONCLUSION: Many SRs and CPGs included already or later retracted RCTs without caution. Most of them were never corrected. The scientific community, including publishers and researchers, should make systematic and concerted efforts to remove the impact of retracted RCTs.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Revisiones Sistemáticas como Asunto , Estudios EpidemiológicosRESUMEN
OBJECTIVES: We aimed to evaluate the characteristics, quality, and related factors of the Japanese Clinical Practice Guidelines (CPGs) published in recent years. STUDY DESIGN AND SETTING: In this cross-sectional, meta-epidemiological study, we conducted a Google search for CPGs published by 30 Japanese medical societies that are the basis for training specialties between 2018 and 2019. We used the Appraisal of Guidelines for Research & Evaluation II (AGREE II) tool and the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement to evaluate the quality. RESULTS: We included 53 systematic review-based CPGs. The median score was 0.54 (IQR, 0.38-0.62) for Stakeholder involvement, 0.57 (IQR, 0.51-0.66) in Rigor of development, 0.33 (IQR 0.21-0.46) in Applicability, and 0.63 (IQR 0.46-0.73) in Editorial independence. The number of guideline developers/clinical question ratio (odds ratio [OR]: 4.14, 95% confidence interval [CI]: 1.97, 8.70) and the adopted guideline development methods (OR: 3.69, 95% CI: 1.14, 12.0) were significantly related to the Rigor of development. CONCLUSION: The quality of Japanese CPGs published in recent years remains low. Our study suggests that increasing contributors and adopting the latest guideline development methods at the beginning of the project may improve the quality of the Japanese CPGs.
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Protocolos Clínicos/normas , Estudios Epidemiológicos , Guías de Práctica Clínica como Asunto/normas , Estudios Transversales , Humanos , JapónRESUMEN
PURPOSE: The aim of the study was to investigate if ultrasound probes are reusable medical devices that risk becoming contaminated after a patient examination in Japan. METHODS: The level of bacterial contamination on transvaginal ultrasound (TVU) probes following current routine probe cleaning at a university hospital (site A) and a clinic (site B) in Japan was investigated. RESULTS: A total of 98.1% of probes were found to be contaminated at site A (median CFU 40, IQR 10, 132.5) and 94.1% were found to be contaminated at site B (median CFU 50, IQR 20, 85). Of the contaminated probes, 52.9% at site A and 64.6% at site B harbored potentially pathogenic bacteria including methicillin-resistant Staphylococcus aureus (MRSA). CONCLUSION: These findings suggest that there is a high rate of ultrasound probe residual bacterial contamination in Japan.
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Bacterias/aislamiento & purificación , Contaminación de Equipos/estadística & datos numéricos , Equipo Reutilizado/estadística & datos numéricos , Ultrasonografía/instrumentación , Femenino , Hospitales Universitarios , Humanos , Incidencia , JapónRESUMEN
Gauze counting is regarded as the most essential way to prevent forgotten gauze inside the body during any surgery. However, incident may still occur due to artificial mistake. An open fan sign on ultrasonography may indicate a gauze left in the intrauterine cavity.