Development of a Novel Scoring System to Quantify the Severity of Incident Reports: An Exploratory Research Study.

Incident reporting systems have been widely adopted to collect information about patient safety incidents. Much of the value of incident reports lies in the free-text section. Computer processing of semantic information may be helpful to analyze this. We developed a novel scoring system for decision making to assess the severity of incidents using the semantic characteristics of the text in incident reports, and compared its results with experts' opinions. We retrospectively analyzed free-text data from incident reports from January 2012 to September 2021 at Nagoya University Hospital, Aichi, Japan. The sample was allocated to training and validation datasets using the hold-out method. Morphological analysis was used to segment terms in the training dataset. We calculated a severity term score, a severity report score and severity group score, by report volume size, and compared these with conventional severity classifications by patient safety experts and reporters. We allocated 96,082 incident reports into two groups. We calculated 1,802 severity term scores from the 48,041 reports in the training dataset. There was a significant difference in severity report score between reports categorized as severe and not severe by experts (95% confidence interval [CI] -0.83 to -0.80, p < 0.001, d = 0.81). Severity group scores were positively associated with severity ratings from experts and reporters (correlation coefficients 0.73 [95% CI 0.63-0.80, p < 0.001] and 0.79 [95% CI 0.71-0.85, p < 0.001]) for all departments. Our severity scoring system could therefore contribute to better organizational patient safety.

BK-UM in patients with recurrent ovarian cancer or peritoneal cancer: a first-in-human phase-I study.

BACKGROUND: BK-UM (CRM197) is a mutant form of diphtheria toxin and a specific inhibitor of heparin-binding epidermal growth factor-like growth factor (HB-EGF). We assessed the safety, pharmacokinetics, recommended dose, and efficacy of BK-UM in patients with recurrent ovarian cancer (OC) or peritoneal cancer (PC), and measured HB-EGF levels in serum and abdominal fluid after BK-UM administration. METHODS: Eleven patients with advanced or recurrent OC or PC were enrolled and treated with BK-UM via the intraperitoneal route. The dose was escalated (1.0, 2.0, 3.3, and 5.0 mg/m2) using a 3 + 3 design. RESULTS: Eight of 11 patients completed treatment. No dose-limiting toxicity (DLT) was experienced at dose levels 1 (1.0 mg/m2) and 2 (2.0 mg/m2). Grade 3 transient hypotension as an adverse event (defined as a DLT in the present study) was observed in two of four patients at dose level 3 (3.3 mg/m2). Treatment with BK-UM was associated with decreases in HB-EGF levels in serum and abdominal fluid in seven of 11 patients and five of eight patients, respectively. Clinical outcomes included a partial response in one patient, stable disease in five patients, and progressive disease in five patients. CONCLUSIONS: BK-UM was well tolerated at doses of 1.0 and 2.0 mg/m2, with evidence for clinical efficacy in patients with recurrent OC or PC. A dose of 2.0 mg/m2 BK-UM is recommended for subsequent clinical trials. TRIAL REGISTRATION: This trial was prospectively performed as an investigator-initiated clinical trial. The trial numbers are UMIN000001002 and UMIN000001001, with registration dates of 1/30/2008 and 2/4/2008, respectively. UMIN000001001 was registered as a trial for the continuous administration of BK-UM after UMIN000001002 .

Chorioamnionitis caused by Staphylococcus aureus with intact membranes in a term pregnancy: A case of maternal and fetal septic shock.

Chorioamnionitis is usually caused by migration of cervicovaginal flora through the cervical canal in women with ruptured membranes. Common causative pathogens are genital mycoplasmas, anaerobes, enteric gram-negative bacilli, and group B streptococcus. There have been only seven previous reports of chorioamnionitis due to Staphylococcus aureus and their clinical courses are characterized by rapid disease progression and poor prognosis. This case report describes a case of acute chorioamnionitis due to S. aureus, which was successfully managed with immediate cesarean section and postoperative intensive care. A 22-year-old woman presented at 39 weeks' gestation with a fever and acute lower abdominal pain. Fetal heart monitoring showed fetal distress. Immediate cesarean delivery was performed under general anesthesia. A male infant weighing 2450 g was born. He had Apgar scores of 3 and 7 at 1 and 5 min, respectively. He was immediately intubated and admitted to the neonatal intensive care unit. Maternal blood culture, vaginal culture, neonatal nares, and blood and gastric fluid culture all showed methicillin-sensitive S. aureus. Histopathology of the placenta demonstrated focal acute funisitis and acute chorioamnionitis. Interestingly, most of the patients in the previous reports developed chorioamnionitis due to S. aureus despite the presence of intact membranes, as in our case. Bacterial spread in the absence of membrane rupture and the presence of bacteremia suggests hematogenous, rather than ascending, etiology of S. aureus chorioamnionitis.

Enhancing Healthcare Accountability for Administrators: Fostering Transparency for Patient Safety and Quality Enhancement.

Transparency in healthcare organizations is essential for creating a culture of patient-centered care where patients are respected, informed, and actively engaged in their health and well-being. Organizational transparency is a crucial element in healthcare, enhancing patient safety and quality improvement. Transparency involves open communication about healthcare organizations' performance, outcomes, and processes, leading to improved accountability, trust, and patient engagement. Transparent organizations prioritize patient-centered care, involving patients in decision-making and fostering shared mental models between healthcare providers and patients. Psychological safety is vital for organizational transparency. Patient safety reporting systems play a key role in transparency, allowing anonymous reporting of safety concerns and incidents. These systems facilitate early risk identification, continuous improvement, and compliance with regulatory requirements. Transparency in reporting encourages a culture of openness, learning from near misses, and addressing systemic issues and human errors. It aligns with ethical principles, potentially mitigating legal challenges. This review synthesizes key themes, including the importance of patient-centered care, the role of psychological safety in fostering transparency, and the effectiveness of patient safety reporting systems.

Patient engagement with psychological safety.

Psychological safety is a multidimensional, dynamic phenomenon that concerns team members' perception of whether it is safe to take interpersonal risks at work. It is particularly important within health care teams who need to work interdependently to coordinate safe patient care within a highly complex, variable and high-stakes work environment. High levels of psychological safety have clear benefits for patient safety by improving the delivery of clinical care and promoting health care providers' job satisfaction and well-being. Feeling psychologically safe can enable team members to engage in speaking up behavior, such as asking questions, pointing out mistakes, or reporting errors. Several studies have explored psychological safety in health care teams and its impact on patient safety. These studies have highlighted the importance of psychological safety in health care organizations and provided strategies for promoting psychological safety. Psychological safety in health care involvement with patients can improve patient engagement.

Clinical significance of amphiregulin and epidermal growth factor in colostrum.

BACKGROUND: Colostrum contains a wide variety of crucial nutritional elements including growth factors for newborn infants to adapt to the extrauterine environment. OBJECTIVE: To investigate the clinical significance of epidermal growth factor receptor ligands in milk during the first month of lactation. METHODS: The concentrations of epidermal growth factor (EGF), amphiregulin (AR) and transforming growth factor-α (TGF-α) in milk sampled from a total of 31 normal mothers at days 1-3, 5, and 30 postpartum were examined using ELISA. RESULTS: At days 1-3, the concentration of EGF was extremely high [131.6 ± 20.4 (mean ± SEM) ng/ml] compared to that of AR (4,197.2 ± 1,055.2 pg/ml) or TGF-α (261.7 ± 33.6 pg/ml), while the concentration of AR was significantly elevated compared to that of TGF-α. At days 5 and 30, the concentration of EGF was significantly elevated compared to that of AR or TGF-α. In 16 mothers among the same 31 subjects, samples were longitudinally obtained on days 1, 2, 5, and 30 postpartum. Concentrations of AR were higher on days 1 and 2 and rapidly declined to below 1 ng/ml on day 5, and were maintained at lower levels on day 30. Concentrations of EGF were high on day 1 (greater than 10 ng/ml) but gradually declined by days 2, 5, and 30. Concentrations of TGF-α remained at lower levels of below 1 ng/ml throughout the lactation period from days 1 to 30. CONCLUSION: These results suggested that EGF and amphiregulin in colostrum might contribute to the early stage of development of neonatal gastrointestinal function.

The comprehensive double loop activities for patient safety management.

We practice patient safety as a model that links patient safety and quality improvement in healthcare. The most important activity is the incident report. The loop on the left is during usual situation activity related to quality improvement in healthcare. The loop on the right is during critical situations activity related to patient safety. What is important in these activities is the initial response to the critical situation, which is the first corner of the right loop. We practice emphasizing the initial response to the critical situation, creating the pattern, and taking measures without omissions. Although many patient safety measures have been taken, it has become clear that there is a shortage of doctors who can practice them. We have practiced that pattern and supported advanced healthcare. We want you to explain the pattern and use it in practice.

Assessment of medical malpractice cost at a Japanese national university hospital.

Medical safety management has an economic dimension that has received little attention. Medical expenses associated with medical malpractice in Japan should be investigated in relation to patient safety measures and their consequences. We analyzed medical accidents that occurred within the past seven years at a university hospital. We determined that 197 accidents involved negligence by the hospital in the years from 2011 to 2017, for which the institution bore the costs of the resulting treatment; those expenses totaled JPY 30.547 million. Most incidents occurred in the hospital ward (82, 41.6%); those in the operating room were the most expensive (JPY 19.493 million, 63.8%). The greatest number of cases involved drug administration (63, 32.0%). Materials inadvertently left in surgical sites ("remnants") cost the hospital the most per incident (JPY 9.767 million, 32.0%). Of these, medical treatment costs for remnants associated with vascular invasion were the highest. Although the total number of malpractice incidents increased over time, the annual cost to the hospital decreased, especially in cases in which costs exceeded JPY 100,000, and those associated with the operating room. Our results suggested that adverse events must be addressed to foster patient safety, decrease medical expenses, and improve hospital administrative capacity.

Amphiregulin regulates the activation of ERK and Akt through epidermal growth factor receptor and HER3 signals involved in the progression of pancreatic cancer.

Pancreatic cancer is one of the most lethal malignancies. Epidermal growth factor receptor (EGFR), HER3, Akt, and amphiregulin have been recognized as targets for pancreatic cancer therapy. Although gemcitabine + erlotinib has been the recommended chemotherapy for pancreatic cancer, the prognosis is extremely poor. The development of molecularly targeted therapies has been required for patients with pancreatic cancer. To assess the validation of amphiregulin as a target for pancreatic cancer therapy, we examined its expression in pancreatic cancer using real-time PCR analyses and ELISA. We also measured the apoptotic cell rate using TUNEL assays. In addition, alterations in signaling pathways were detected by immunoblotting analyses. Treatment with gemcitabine, which reduced the cell viability and augmented the cell apoptotic rate, activated and subsequently attenuated ERK and EGFR signals. However, gemcitabine, paclitaxel, or cisplatin treatment enhanced the Akt activation, heterodimer formation of EGFR with HER3, and secretion of amphiregulin, indicating that the presence of gemcitabine promoted the activity of targeted molecules including amphiregulin, Akt, and HER3 for pancreatic cancer therapy. Combined treatment with an inhibitor for amphiregulin and gemcitabine, paclitaxel, or cisplatin induced synergistic antitumor effects, accompanied by the suppression of Akt and ERK activation. Blockade of amphiregulin suppressed the activities of EGFR, HER3, and Akt and the expression of amphiregulin itself. According to this evidence, combination chemotherapy of conventional anticancer drugs plus an inhibitor for amphiregulin would allow us to provide more favorable clinical outcomes for patients with pancreatic cancer.

Longitudinal changes in canal length at 16-35 weeks in normal twin pregnancies and twin pregnancies with preterm labor and delivery.

AIM: To describe the longitudinal changes in canal length at 16-35 weeks' gestation in cases of twin pregnancy with preterm labor and delivery. METHODS: We studied 22 cases of twin pregnancy that were delivered at < 36 weeks and/or that underwent preterm labor requiring tocolysis. We also studied 44 cases of twin pregnancy delivered at > or = 36 weeks without tocolysis (non-tocolysis twin pregnancy). Controls were 82 cases of normal singleton pregnancy. Canal length was longitudinally measured using transvaginal ultrasonography. The observational period of 16-35 weeks was divided into 4-week periods for analysis. RESULTS: From 28 to 31 weeks onwards the canal length of non-tocolysis twin pregnancies was shorter than that of normal singleton pregnancies (P < 0.05). The canal length of twin pregnancies with preterm labor and delivery was shorter than that of non-tocolysis twin pregnancies at 16-19 weeks and decreased rapidly until 24-27 weeks (P < 0.01). CONCLUSIONS: A short canal length at 16-19 weeks followed by rapid canal length shortening in the second trimester are specific characteristics in preterm labor and delivery of twin pregnancies. Sequential measurements of canal length in the second trimester starting at < 20 weeks may be a suitable parameter to predict preterm labor and delivery in twin pregnancies.

Significance of incident reports by medical doctors for organizational transparency and driving forces for patient safety.

BACKGROUND: Incident reporting is an effective strategy used to enhance patient safety and quality improvement in healthcare. An incident is an event that could eventually result in harm to a patient. The aim of this study is to re-evaluate the importance of reporting by medical doctors to improve quality in healthcare and patient safety. METHODS: We conducted a retrospective analysis of the reported incidents registered in our institutional database from April 1st 2015 to March 31st 2019, classified according to eight variables proposed by the National University Hospital Council of Japan, to determine the type of incidents and their potential harm to patients. RESULTS: Registered reports totalled 43,775, approximately 8% of which arise annually from medical doctors in clinical departments. Incidents with higher impact on patients have significantly increased the rate of reporting by medical doctors. The most frequent types of report overall concerned medication incidents, followed by infusion lines, drainage-tube devices, cure, examination, and treatment outside the operating room. The most frequent reports by medical doctors involved operation-related incidents, followed by cure, examination, treatment outside the operation room, and medications. CONCLUSION: Reporting by medical doctors reflects the organizational transparency and the driving forces behind patient safety and quality improvement in healthcare. Efforts toward seamless improvement in patient safety and quality at our hospital continue apace.

Enhanced hospital-wide communication and interaction by team training to improve patient safety.

Communication errors are the most important cause of adverse events in healthcare. The current study aimed to improve hospital-wide employee teamwork and reduce adverse medical events for patients arising from miscommunication. In our hospital, when patient safety incidents and accidents occur, staff from various occupations submit incident reports to the Department of Patient Safety via an electronic reporting system; over 11,000 cases are reported each year. We surveyed the incident reports submitted in our institution from 2016 to 2018. All incidents related to miscommunication were identified, and relevant information was collected from the original electronic incident reports. Incident severity classification is commonly divided into near-miss or adverse events. We extracted only the required incident information items for this study, and processed information concerning individuals (e.g., reporters and target patients) anonymously. This study was approved by the Institutional Review Board of the study hospital. The authors declare no conflicts of interest associated with this study. Team training for all employees reduced adverse events for patients. The coefficient of determination (R squared value) was -0.32. This suggests our approach may be slightly but significantly effective for developing the fundamental strengths of the medical team. Quality improvement is continuous, and seamless efforts to improve the effectiveness of medical teams at our hospital will continue.

Intervention efficacy for eliminating patient misidentification using step-by-step problem-solving procedures to improve patient safety.

This study aimed to evaluate the efficacy of interventions to reduce patient misidentification incidents classified as level 2 and over (adverse events occurred for patients) with the step-by-step problem-solving method. All incidents related to patient misidentification were selected, and relevant information was collected from the original electronic incident reports. We then conducted an eight-step problem-solving process with the aim of reducing patient misclassification and improving patient safety. Step 1: the number of misidentification-related incident reports and the percentage of these reports in the total incident reports increased each year. Step 2: the most frequent misidentification type was sample collection tubes, followed by drug administration and hospital meals. Step 3: we set a target of an 20% decrease in patient misidentification cases classified as level 2 or over compared with the previous year, and established this as a hospital priority. Step 4: we found that discrepancies in patient identification procedures were the most important causes of misidentification. Step 5: we standardized the patient identification process to achieve an 10% reduction in misidentification. Step 6: we disseminated instructional videos to all staff members. Step 7: we confirmed there was an 18% reduction in level 2 and over patient misidentification compared with the previous year. Step 8: we intend to make additional effort to decrease misidentification of patients by a further 10%. Level 2 and over patient misidentification can be reduced by a patient identification policy using a step-by-step problem-solving procedure. This study aimed to evaluate the efficacy of interventions to reduce patient misidentification incidents with step-by-step problem-solving method. Continued seamless efforts to eliminate patient misidentification are mandatory for this activity.

Potential for molecularly targeted therapy against epidermal growth factor receptor ligands.

Monoclonal antibodies and tyrosine kinase inhibitors against ErbB receptors have been developed and have progressed to clinical applications following several decades of research in cancer cell biology. Inhibition of epidermal growth factor receptor (EGFR) signaling represents a particularly promising arena for the application of molecularly targeted cancer therapies. In EGFR signaling inhibition, EGFR itself has been recognized as a target in epithelial malignancies, though clinical studies using EGFR antagonists have not always resulted in favorable clinical outcomes. The aberrant enhancement of EGFR ligand expression is speculated to be one of several different molecular mechanisms accounting for the acquired resistance to EGFR antagonists. Recently, emerging evidence has indicated that EGFR ligands deserve considerable attention as potential targets for cancer therapy. In this review, we discuss the EGFR signaling inhibition strategies directed at EGFR ligands such as HB-EGF and amphiregulin.

Incidence and risk factors for postpartum hemorrhage among transvaginal deliveries at a tertiary perinatal medical facility in Japan.

Postpartum hemorrhage (PPH) remains a leading cause of maternal death worldwide, and it is important to understand the relative contributions of different risk factors. We assessed the incidence of these among cases of transvaginal delivery. Between June 2013 and July 2016, a prospective cohort study was conducted at a tertiary perinatal medical facility in Japan. Women were administered a questionnaire to ascertain risk factors for PPH, defined as a blood loss of 1,000 ml or more assessed using a calibrated under-buttocks drape and collection vessel at childbirth. We analyzed 1,068 transvaginal deliveries of singleton pregnancies. The incidence of PPH was 8.7%, and of severe PPH (1,500 ml blood loss or more) was 2.1%. Risk factors for postpartum hemorrhage among the deliveries were: fetal macrosomia (over 4000 g); pregnancy-induced hypertension; pregnancy generated by assisted reproductive technology; severe vaginal or perineal lacerations; and weight gain over 15 kg during pregnancy. Such high weight gain significantly increased the incidence of PPH compared with women showing less than 10 kg weight gain during pregnancy. Monitoring these identified risk factors could enable extra vigilance during labor, and preparedness for managing PPH in all women giving birth.

Malignant lymphoma of the uterine cervix presumptively diagnosed by Pap smear: A case report.

Malignant lymphoma of the uterine cervix is exceedingly rare and is difficult to diagnose by cervical cytology. The current study presents a case of malignant lymphoma of the uterine cervix that was presumptively diagnosed by cervical cancer screening in which the patient had no clinical symptoms. The anterior lip of the uterine cervix was occupied by a macroscopic hemorrhagic tumor. The obtained tumor cells exhibited typical cytological features of malignant lymphoma and were positive for CD20. The final diagnosis was diffuse large B cell lymphoma of the uterine cervix, stage IIEA (Ann Arbor classification). The patient received 6 courses of R-CHOP chemotherapy and achieved complete remission. Despite its rarity, the possibility of malignant lymphoma should be considered while screening for cervical cancers using Pap smears. The Pap test screening may be useful for the early diagnosis of malignant lymphoma of the uterine cervix in certain cases. By reaching a rapid and accurate diagnosis, immediate treatment may be initiated and surgery may be avoided.

Choosing the uterine preservation surgery for placental polyp determined by blood flow evaluation: A retrospective cohort study.

BACKGROUND: A placental polyp is an intrauterine polypoid mass or pedunculated mass occurring from residual trophoblastic tissue following abortion, cesarean section or vaginal delivery. Recently uterine preservation surgery represented by transcervical resection (TCR) has been performed for placental polyps. However TCR without intravascular intervention, including uterine artery embolization (UAE) may cause profound bleeding which necessitate emergency laparotomy. METHODS: Seventeen cases of placental polyp were retrospectively examined. We divided cases into two groups: strong vascularity group (n = 13) and weak vascularity group (n = 4). Mass extraction of polyp by TCR was conducted in 16 cases, 6 case without UAE and 10 cases with UAE. RESULTS: As for the weak vascularity group, one case was naturally resolved while planning surgery and 3 cases were treated with TCR without UAE without major intra- and/or postoperative bleeding. On the other hand in the strong vascularity group, 2 out of 3 cases of TCR without UAE resulted in major bleeding during and after the surgery, both needed transfusion and one needing postoperative UAE. Ten cases of strong vascularity group, TCR with UAE were performed and all of them were accomplished without major bleeding. TCR without UAE was safely performed in cases where there was absent or mild to moderate blood flow. CONCLUSIONS: Our report suggests that adding UAE might be safer to treat placental polyps that have strong vascularity.

Possible applications of antibodies or their genes in cancer therapy.

In this review article the possible applications of anti-tumor-associated antigen (TAA) antibodies in the therapy of cancer have been summarized. First, recombinant monoclonal antibodies (MAbs) are increasingly being used as therapeutic agents, especially in combination with anti-cancer drugs. Second, conjugation of antibody therapy with toxins or radioisotopes offers more therapeutic approaches. Third, development of cytotoxic T-lymphocyte (CTL) or natural killer (NK)-cell populations with anti-TAA antibody activity may be important for the success of cancer immunotherapy because the downregulated HLA class I molecules and the non-ubiquitous expression of NK receptor ligands in tumor tissues constitute the major tumor escape mechanism facing tumor-specific CTL- and/or NK-cell-mediated responses. Finally, in cancer gene therapy, the strategies to target viral vectors carrying therapeutic genes to tumor tissues by modifying the tropisms with MAbs or their genes against TAAs are also very promising.

Sonographic findings of transvaginal color Doppler ultrasound in ectopic pregnancy.

PURPOSE: The objective of this study was to retrospectively assess whether the sonographic findings from transvaginal color Doppler ultrasound (TV-CDU) are helpful in the diagnosis of ectopic pregnancy. METHODS: Thirty-four patients who received surgery for ectopic tubal pregnancies were preoperatively evaluated using TV-CDU. The presence or absence of color vascularity within the ectopic masses was examined. The relationship between the presence or absence of blood flow in the tubal mass and the corpus luteum cyst, or the serum ß-hCG values, was evaluated. RESULTS: Color vascularity within the adnexal mass was detected in 27 of 34 (79.4%) patients with ectopic pregnancies by TV-CDU. Color vascularity within the mass was observed in 18 of 24 (75.0%) patients with a questionable adnexal mass that had no obvious gestational sac in B-mode images. Moreover, color vascularity was seen in all four patients with a serum ß-human chorionic gonadotropin (ß-hCG) value of less than 500 mIU/ml. However, it was difficult to identify the blood flow of the adnexal mass in six of the nine (66.7%) patients with a corpus luteum cyst in the ipsilateral ovary. No relationship was observed between the serum ß-hCG concentrations and the resistance indices, or the peak systolic velocity. CONCLUSIONS: The detection of color vascularity by TV-CDU in patients with an ectopic pregnancy is helpful for diagnosis, especially for patients with either a questionable adnexal mass in B-mode images or lower serum ß-hCG concentrations.