Translational Research Informatics Center (Japan)

Objectivelarge-scale multicentre clinical trials conducted by cooperative groups have generated a lot of evidence to establish better standard treatments. The Clinical Trials Act was enforced on 1 April 2018, in Japan, and it has remarkably increased the operational burden on investigators, but its long-term impact on cancer cooperative groups is unknown.Methodsa survey was conducted across the nine major cooperative groups that constitute the Japan Cancer Trials Network to assess the impact of Clinical Trials Act on the number of newly initiated trials from fiscal year (from 1 April to 31 March) 2017 to 2022 and that of ongoing trials on 1 April in each year from 2018 to 2023.Resultsthe number of newly initiated trials dropped from 38 trials in fiscal year 2017 to 26 trials in fiscal year 2018, surged to 50 trials in fiscal year 2019, but then gradually decreased to 25 trials by fiscal year 2022. Specified clinical trials decreased from 32 trials in fiscal year 2019 to 12 trials in fiscal year 2022. The number of ongoing trials was 220 trials in 2018, peaked at 245 trials in 2020, but then gradually decreased to 219 trials by 2023. The number of specified clinical trials has been in consistent decline. By April 2023, of the 20 ongoing non-specified clinical trials, nine adhered to Clinical Trials Act and 11 followed the Ethical Guidelines for Medical and Health Research Involving Human Subjects.Conclusionthe number of multicentre clinical trials in oncology gradually decreased after the Clinical Trials Act’s enforcement, which underscores the need for comprehensive amendment of the Clinical Trials Act to streamline the operational process.

Disclosure of sexual orientation and gender identity correlates with better outcomes, yet data may not be available in structured fields in electronic health record data. To gain greater insight into the care of sexual and gender-diverse patients in the Veterans Health Administration (VHA), we examined the documentation patterns of sexual orientation and gender identity through extraction and analyses of data contained in unstructured electronic health record clinical notes. Salient terms were identified through authoritative vocabularies, the research team's expertise, and frequencies, and the use of consistency in VHA clinical notes. Term frequencies were extracted from VHA clinical notes recorded from 2000 to 2018. Temporal analyses assessed usage changes in normalized frequencies as compared with nonclinical use, relative growth rates, and geographic variations. Over time most terms increased in use, similar to Google ngram data, especially after the repeal of the "Don't Ask Don't Tell" military policy in 2010. For most terms, the usage adoption consistency also increased by the study's end. Aggregated use of all terms increased throughout the United States. Term usage trends may provide a view of evolving care in a temporal continuum of changing policy. These findings may be useful for policies and interventions geared toward sexual and gender-diverse individuals. Despite the lack of structured data, the documentation of sexual orientation and gender identity terms is increasing in clinical notes.

The correlation of non-invasive optical neuromonitoring of cerebral oxygenation versus systemic predictors of resuscitation success were assessed in a pediatric swine model of asphyxia-associated cardiac arrest and cardiopulmonary resuscitation.

ObjectiveTo develop prediction models for intensive care unit (ICU) vs non-ICU level-of-care need within 24 hours of inpatient admission for emergency department (ED) patients using electronic health record data.Materials and MethodsUsing records of 41 654 ED visits to a tertiary academic center from 2015 to 2019, we tested 4 algorithms—feed-forward neural networks, regularized regression, random forests, and gradient-boosted trees—to predict ICU vs non-ICU level-of-care within 24 hours and at the 24th hour following admission. Simple-feature models included patient demographics, Emergency Severity Index (ESI), and vital sign summary. Complex-feature models added all vital signs, lab results, and counts of diagnosis, imaging, procedures, medications, and lab orders.ResultsThe best-performing model, a gradient-boosted tree using a full feature set, achieved an AUROC of 0.88 (95%CI: 0.87–0.89) and AUPRC of 0.65 (95%CI: 0.63–0.68) for predicting ICU care need within 24 hours of admission. The logistic regression model using ESI achieved an AUROC of 0.67 (95%CI: 0.65–0.70) and AUPRC of 0.37 (95%CI: 0.35–0.40). Using a discrimination threshold, such as 0.6, the positive predictive value, negative predictive value, sensitivity, and specificity were 85%, 89%, 30%, and 99%, respectively. Vital signs were the most important predictors.Discussion and ConclusionsUndertriaging admitted ED patients who subsequently require ICU care is common and associated with poorer outcomes. Machine learning models using readily available electronic health record data predict subsequent need for ICU admission with good discrimination, substantially better than the benchmarking ESI system. The results could be used in a multitiered clinical decision-support system to improve ED triage.

Gaps in generation and timely transfer of relevant information during care transitions remain a greatchallenge to care coordination. Electronic Health Record (EHR) based information transfer tools are notefficiently used by most providers. The objective of this project was to understand the current process of caretransition between ambulatory and inpatient care setting and to explore the utilization and scope of an EHRbased Longitudinal Plan of Care in improving coordination during care transition. The Longitudinal Planof Care when compared with transition of care practices recommended by Transitions of Care ConsensusConference and National Transitions of Care Coalition work group showed that it lacked some informationpertinent to care coordination. The survey performed indicated that most commonly used Electronic HealthRecord tool for care transition were notes and chart reviews (97.4%, 93.4%). Only 12% of the participantsexpressed high satisfaction with the currently used tool. Among the participants who used the LongitudinalPlan of Care, only 8.8% reported it as a sufficient tool for information transfer. Majority (93.5%) wereunaware that such a tool existed and had never explored its functionality. Improving the functionality ofLongitudinal Plan of Care and training health care providers can greatly facilitate information transferduring care transition.

We conducted an investigator-initiated multicenter clinical trial targeting patients suffering from Familial Mediterranean Fever (FMF). Due to the rarity of the disease, the absolute number of candidates in Japan was considerably small (500 at most). We proceeded with subject recruitment and implemented methods to achieve the target study sample. Our operations team promoted patient recruitment by employing multiple strategies throughout the patient recruitment period. We achieved 95％ of the target study sample of 23 patients. Fifty patients gave informed consent to participate in the trial. We found that the flexibility according to the situation is an important and necessary element for successful recruitment.

Correction for ‘Synthesis of heteroleptic phosphine–copper(i) complexes: fluorescence sensing and catalytic properties’ by Chen-Lin Luo et al., New J. Chem., 2021, 45, 8910–8917, DOI: 10.1039/D0NJ06095J.

Methods to assess environmental exposure to hazardous chemicals have primarily focused on quantification of individual chemicals, although chemicals often occur in mixtures, presenting challenges to the traditional risk characterization framework. Sampling sites in a defined geographic region provide an opportunity to characterize chemical contaminants, with spatial interpolation as a tool to provide estimates for non-sampled sites. At the same time, the use of in vitro bioactivity measurements has been shown to be informative for rapid risk-based decisions. In this study, we measured in vitro bioactivity in 39 surface soil samples collected immediately after flooding associated with Hurricane Harvey in Texas in a residential area known to be inundated with polycyclic aromatic hydrocarbon (PAH) contaminants. Bioactivity data were from a number of functional and toxicity assays in 5 human cell types, such as induced pluripotent stem cell-derived hepatocytes, cardiomyocytes, neurons, and endothelial cells, as well as human umbilical vein endothelial cells. Data on concentrations of PAH in these samples were also available and the combination of data sources offered a unique opportunity to assess the joint spatial variation of PAH components and bioactivity. We found significant evidence of spatial correlation of a subset of PAH contaminants and of cell-based phenotypes. In addition, we show that the cell-based bioactivity data can be used to predict environmental concentrations for several PAH contaminants, as well as overall PAH summaries and cancer risk. This study's impact lies in its demonstration that cell-based profiling can be used for rapid hazard screening of environmental samples by anchoring the bioassays to concentrations of PAH. This work sets the stage for identification of the areas of concern and direct quantitative risk characterization based on bioactivity data, thereby providing an important supplement to traditional individual chemical analyses by shedding light on constituents that may be missed from targeted chemical monitoring.

Aim: Posterior circulation stroke (PCS) has different clinical features and prognosis compared with anterior circulation stroke (ACS), and whether the effect of statin therapy on stroke prevention differs according to infarction location remains unclear. This post hoc analysis of the J-STARS study aimed to compare the usefulness of statin at different infarction locations (i.e., ACS and PCS).Methods: In the J-STARS study, 1578 patients were randomly assigned to the pravastatin or control group. The subjects were divided into two subgroups (ACS and PCS groups) based on the arteries responsible for the infarction. Cox proportional hazards models were used to investigate whether the all stroke recurrence rate was different between the ACS and PCS groups.Results: The PCS group (n = 499) had a significantly higher prevalence of diabetes than the ACS group (n = 1022) (30.7% vs. 19.8%, P < 0.001). During the follow-up (4.9 ± 1.4 years), the incidence of all stroke was significantly lower in the pravastatin group than in the control group among patients with PCS (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25–0.83, P = 0.009); however, the stroke recurrence rates were not significantly different between both groups among patients with ACS (adjusted HR 1.32, 95% CI 0.93–1.88, P = 0.123). A significant interaction between the ACS and PCS groups in terms of pravastatin effects was noted (P = 0.003 for interaction).Conclusions: Pravastatin significantly reduced the recurrence rate of all stroke among patients with PCS. Thus, the effect of statin on the recurrence of stroke may differ according to infarction location.

Background:The potential association between hepatitis B virus (HBV) infection and development of osteoporosis has drawn significant attention from clinicians and researchers in recent years due to the increasing prevalence of HBV infection. This study aims to perform a systematic review and meta-analysis of the literature to show whether HBV infection is associated with an increased risk of osteoporosis.Methods:Case-control, cohort, and cross-sectional studies that report the incidence of osteoporosis, osteoporotic fracture, osteopenia, and bone mineral density level in populations with HBV infection will be selected. Four databases from their inception to October 2019 will be searched. All data were assessed and extracted by 2 authors independently. The Newcastle–Ottawa scale and (Agency for Healthcare Research and Quality) Agency for Healthcare Research and Quality checklist will be used to assess the quality of the selected studies. Stata 15.1 (Stata Corp, College Station, TX) will be used to conduct meta-analysis.Result:The results of this systemic review and meta-analysis will be submitted to a recognized journal for publication.Conclusion:This systemic review and meta-analysis will determine whether HBV infection is associated with an increased risk of osteoporosis. We hope this review can provide a reliable evidence.Registration:PROSPERO (registration number CRD42020140522).