Japan Obstetric Compensation System for Cerebral Palsy: Strategic system of data aggregation, investigation, amelioration and no-fault compensation.

The Japan Obstetric Compensation System for Cerebral Palsy (JOCS-CP), which investigates, develops preventive mechanisms and awards monetary compensation, to cases of cerebral palsy was urgently introduced in 2009 in response to growing concern about Japan's deteriorating perinatal care and low birthrate. Under the political leadership, the Japan Council for Quality Health Care launched the JOCS-CP with support of various stakeholders. The JOCS-CP features of no-fault-based compensation which was discussed decades ago in the Japan Medical Association aiming at financial aid to patient and family and early settlement of dispute. As of 2017, 2233 petitions had been approved by the Review Committee for compensation. All the approved cases were consecutively put on analysis in the Investigation Committee which has compiled more than 1000 Investigative Reports. The reports were delivered not only to the childbirth facility but to the guardians/families. Survey revealed that most of childbirth facility and the guardians/families responded in favor of the reports. With regard to amelioration of profound cerebral palsy, the Prevention Report has been published on annual basis through analysis of all the Investigative Reports. The Prevention Reports and other educational materials were produced and distributed not only among medical professionals but among pregnant women. It is notable that the number of lawsuit filing related to obstetrics demonstrated rapid decrease compared to that of other medical specialties. The JOCS-CP could be described as a social experiment. It was overhauled in 2015 but deserves further discussion on reform for evolving into better system.

Analysis of antenatal-onset cerebral palsy secondary to transient ischemia in utero using a national database in Japan.

AIM: We conducted a retrospective analysis of summary medical reports of children diagnosed with cerebral palsy (CP) to identify clinical features of antenatal onset of CP secondary to transient ischemia in utero. METHODS: The 658 brief summary reports available in the Japan Obstetric Compensation System for Cerebral Palsy were screened, and we identified cases of singleton pregnancy, delivered at gestational age ≥ 33 weeks and those with cord blood gas pH ≥ 7.20. Of the 137 cases identified, 84 were excluded for the following reasons: no evidence of ischemic brain lesion, clear post-natal causative factor of CP, presence of a congenital condition, and sentinel hypoxic event, such as uterine rupture. The demographic profiles of the 53 cases included in our analysis were compared to identify those with and without an abnormal variability in fetal heart rate. RESULTS: Between-group comparison identified an association between abnormal heart rate variability and a lower Apgar score at 1 min (2 vs 6; P < 0.001) and 5 min (5.5 vs 8; P = 0.002), and more frequent episodes of fetal movement loss (41% vs 10%; P = 0.027). An hypoxic event ≤ 1 week before delivery was more likely to be associated with abnormal heart rate variability (89%) and low Apgar score (82%), while events at > 1 week were associated with development of polyhydramnios (44%). CONCLUSION: In utero transient ischemic events can contribute to term or near-term CP. Careful follow-up is recommended for fetuses with a history of fetal movement loss, abnormal variability in heart rate, and polyhydramnios of unknown causes.

COMPENSATING CEREBRAL PALSY CASES: PROBLEMS IN COURT LITIGATION AND THE NO-FAULT ALTERNATIVE.

Children having cerebral palsy will incur life-long disabilities, which require high costs of medical and nursing care. This imposes a tremendous burden on the families of the affected children, whether financially or emotionally. It is understandable for the affected families to initiate court litigation in order to alleviate the financial burden and at the same time to overcome the emotional pain associated with the permanent and lifetime implications which cerebral palsy entails. However, suing for such injuries in court and identification of medical malpractice is not an easy task for the families. Further, court litigation tends to be tedious, lengthy and unpleasant. The hazards of litigation have prompted several countries to find an available alternative to court litigation, such as the implementation of a no-fault compensation system, to settle these types of claims. Thus, it is much applauded that the Japan Obstetric Compensation System for Cerebral Palsy was established in January 2009, with the aim of helping children with such disabilities to improve their quality of life and to provide monetary compensation in order to lessen the economic burden on the family. The system features two vital pillars; that is, compensation and causal analysis prevention. The system aims at improving the quality of maternity care and analyzing the causes of accidents in order to prevent similar cases from happening in the future. Overall, the system clearly depicts social solidarity in encouraging collective responsibility for the mishaps suffered by the community.

A large dataset of annotated incident reports on medication errors.

Incident reports of medication errors are valuable learning resources for improving patient safety. However, pertinent information is often contained within unstructured free text, which prevents automated analysis and limits the usefulness of these data. Natural language processing can structure this free text automatically and retrieve relevant past incidents and learning materials, but to be able to do so requires a large, fully annotated and validated corpus of incident reports. We present a corpus of 58,658 machine-annotated incident reports of medication errors that can be used to advance the development of information extraction models and subsequent incident learning. We report the best F1-scores for the annotated dataset: 0.97 and 0.76 for named entity recognition and intention/factuality analysis, respectively, for the cross-validation exercise. Our dataset contains 478,175 named entities and differentiates between incident types by recognising discrepancies between what was intended and what actually occurred. We explain our annotation workflow and technical validation and provide access to the validation datasets and machine annotator for labelling future incident reports of medication errors.

A deep learning model based on fusion images of chest radiography and X-ray sponge images supports human visual characteristics of retained surgical items detection.

PURPOSE: Although a novel deep learning software was proposed using post-processed images obtained by the fusion between X-ray images of normal post-operative radiography and surgical sponge, the association of the retained surgical item detectability with human visual evaluation has not been sufficiently examined. In this study, we investigated the association of retained surgical item detectability between deep learning and human subjective evaluation. METHODS: A deep learning model was constructed from 2987 training images and 1298 validation images, which were obtained from post-processing of the image fusion between X-ray images of normal post-operative radiography and surgical sponge. Then, another 800 images were used, i.e., 400 with and 400 without surgical sponge. The detection characteristics of retained sponges between the model and a general observer with 10-year clinical experience were analyzed using the receiver operator characteristics. RESULTS: The following values from the deep learning model and observer were, respectively, derived: Cutoff values of probability were 0.37 and 0.45; areas under the curves were 0.87 and 0.76; sensitivity values were 85% and 61%; and specificity values were 73% and 92%. CONCLUSION: For the detection of surgical sponges, we concluded that the deep learning model has higher sensitivity, while the human observer has higher specificity. These characteristics indicate that the deep learning system that is complementary to humans could support the clinical workflow in operation rooms for prevention of retained surgical items.

Annotation Guidelines for Medication Errors in Incident Reports: Validation Through a Mixed Methods Approach.

At present no adequate annotation guidelines exists for incident report learning. This study aims at utilizing multiple quantitative and qualitative evidence to validate annotation guidelines for incident reporting of medication errors. Through multiple approaches via annotator training, annotation performance evaluation, exit surveys, and user and expert interviews, a mixed methods explanatory sequential design was utilized to collect 2-stage evidence for validation. We recruited two patient safety experts to participate in piloting, three annotators to receive annotation training and provide user feedback, and two incident report system designers to offer expert comments. Regarding the annotation performance evaluation, the overall accuracy reached 97% and 90% for named entity identification and attribute identification respectively. Participants provided invaluable comments and opinions towards improving the annotation methods. The mixed methods approach created a significant evidential basis for the use of annotation guidelines for incident report of medication errors. Further expansion of the guidelines and external validity present options for future research.

Dermatological legal claims in Japan.

Health-care safety management has recently been highlighted for patient safety. However, specialist-based risks in clinical settings have hardly been discussed in Japan so far. A review of dermatological legal claims may delineate these risks. This study examined court precedents from the databases "Courts in Japan" and LEX/DB. Thirty-four dermatology-related civil cases were found from 1968-2006. Of the 34 cases, 32 (94%) were judged and two (6%) were retried. Of these 32 cases, 11 (34%) were appealed to higher courts. Among the 34 litigations, the defendants of eight (23%) were dermatology specialists, 20 (59%) were non-dermatologists and six (18%) of unknown specialty. The defendants' negligence was determined at either level in court in 25 of the 34 cases. The negligence in these 25 cases was categorized into five groups: (i) delayed diagnosis (none); (ii) complication during diagnosis procedure (one, 4%); (iii) inappropriate treatment (nine, 36%); (iv) complication during treatment procedure (10, 40%); and (v) insufficient informed consent (five, 20%). The present study may help to improve strategies for health-care safety management in the dermatological field in Japan.

Phase I study of S-1 and biweekly docetaxel combination chemotherapy for advanced and recurrent gastric cancer.

A phase I study of S-1 and biweekly docetaxel (DOC) combination therapy was conducted to determine the maximum tolerated dose (MTD) and pharmacokinetic parameters. Fourteen patients with advanced or recurrent gastric cancer were analyzed. The treatment consisted of S-1 [body surface area (BSA) <1.25 m2:80 mg/day, 1.25

[Chemotherapy for gastric cancer].

5-FU has been a key chemotherapeutic agent in the treatment of advanced or recurrent gastric cancer. In order to enhance the effect of 5-FU, biochemical modulation or combined chemotherapy has been developed. Although several phase III studies have been reported in 1990's, a standard chemotherapeutic regimen has not been established worldwide. Recently, newly developed anticancer agents such as CPT-11, TS-1, Paclitaxel, or Docetaxel can be clinically used for advanced gastric cancer either single agent or in combination that may further improve the quality of life and prolong the survival of patients with gastric cancer. In Japan, postoperative adjuvant chemotherapy has been actively developed to enhance survival benefit of surgery for patients with gastric cancer. There were a few positive single randomized controlled study showing benefit of adjuvant chemotherapy with a high evidence level. However, all reports of meta-analysis of adjuvant chemotherapy for gastric cancer indicated the survival benefit of adjuvant chemotherapy. At present, a nation-wide randomized controlled study in the postoperative adjuvant setting for gastric cancer using TS-1 (ACTS-GC) is under way that may clarify the effect of postoperative adjuvant chemotherapy in gastric cancer.

Latent transforming growth factor beta-binding protein 1 interacts with fibrillin and is a microfibril-associated protein.

Latent transforming growth factor beta-binding protein 1 (LTBP-1) targets latent complexes of transforming growth factor beta to the extracellular matrix, where the latent cytokine is subsequently activated by several different mechanisms. Fibrillins are extracellular matrix macromolecules whose primary function is architectural: fibrillins assemble into ultrastructurally distinct microfibrils that are ubiquitous in the connective tissue space. LTBPs and fibrillins are highly homologous molecules, and colocalization in the matrix of cultured cells has been reported. To address whether LTBP-1 functions architecturally like fibrillins, microfibrils were extracted from tissues and analyzed immunochemically. In addition, binding studies were conducted to determine whether LTBP-1 interacts with fibrillins. LTBP-1 was not detected in extracted beaded-string microfibrils, suggesting that LTBP-1 is not an integral structural component of microfibrils. However, binding studies demonstrated interactions between LTBP-1 and fibrillins. The binding site was within three domains of the LTBP-1 C terminus, and in fibrillin-1 the site was defined within four domains near the N terminus. Immunolocalization data were consistent with the hypothesis that LTBP-1 is a fibrillin-associated protein present in certain tissues but not in others. In tissues where LTBP-1 is not expressed, LTBP-4 may substitute for LTBP-1, because the C-terminal end of LTBP-4 binds equally well to fibrillin. A model depicting the relationship between LTBP-1 and fibrillin microfibrils is proposed.