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  • 1
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    Effects of a trauma center on early mortality after trauma in a regional city in Japan: a population-based study
    BMJ ; 2019
    In:  Trauma Surgery & Acute Care Open Vol. 4, No. 1 ( 2019-06), p. e000291-
    Details
    In: Trauma Surgery & Acute Care Open, BMJ, Vol. 4, No. 1 ( 2019-06), p. e000291-
    Abstract: Although the effects of the trauma center(TC) were researched in several studies, there have been few studies on changes in the regional mortality due to the implementation of a TC. An emergency medical center (EMC) and TC were implemented at Nagasaki University Hospital (NUH) for the first time in the Nagasaki medical region of Japan in April 2010 and October 2011, respectively, and they have cooperated with each other in treating trauma patients. The purpose of this study was to investigate the effects on the early mortality at population level of a TC working in cooperation with an EMC. Methods This is a retrospective study using standardized regional data (ambulance service record) in Nagasaki medical region from April 2007 through March 2017. We included 19,045 trauma patients directly transported from the scene. The outcome measures were prognosis for one week. To examine the association between the implementation of the EMC and TC and mortality at a region, we fit adjusted logistic regression models. Results The number of patients of each fiscal year increased from 1492 in 2007 to 2101 in 2016. The number of all patients transported to NUH decreased until 2009 to 70, but increased after implementation of the EMC and TC. Overall mortality of all patients in the region improved from 2.3% in 2007 to 1.0% in 2016.In multivariate logistic regression model, odds ratio of death was significantly smaller at 2013 and thereafter if the data from 2007 to 2011 was taken as reference. Conclusions Implementation of the EMC and TC was associated with early mortality in trauma patients directly transported from the scene by ambulance. Our analysis suggested that the implementation of EMC and TC contributed to the improvement of the early mortality at a regional city with 500000 populations. Level of evidence Level III.
    Type of Medium: Online Resource
    ISSN: 2397-5776
    URL: Article
    DOI: 10.1136/tsaco-2018-000291
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2856913-1
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  • 2
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    Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for adult convulsive status epilepticus: a multicentre non-inferiority randomised control trial
    BMJ ; 2023
    In:  Journal of Neurology, Neurosurgery & Psychiatry Vol. 94, No. 1 ( 2023-01), p. 42-48
    Details
    In: Journal of Neurology, Neurosurgery & Psychiatry, BMJ, Vol. 94, No. 1 ( 2023-01), p. 42-48
    Abstract: Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is crucial. Although fosphenytoin (FPHT) is recommended as a second-line treatment, levetiracetam (LEV) reportedly has similar efficacy, but higher safety. Therefore, we herein compared LEV with FPHT in adult SE. Methods We initiated a multicentre randomised control trial in emergency departments with adult patients with convulsive SE. Diazepam was initially administered, followed intravenously by FPHT at 22.5 mg/kg or LEV at 1000–3000 mg. The primary outcome was assigned as the seizure cessation rate within 30 min of the administration of the study drug. Results A total of 176 adult patients with SE were enrolled (82 FPHT and 94 LEV), and 3 were excluded from the full analysis set. Seizure cessation rates within 30 min were 83.8% (67/80) in the FPHT group and 89.2% (83/93) in the LEV group. The difference in these rates was 5.5% (95% CI −4.7 to 15.7, p=0.29). The non-inferiority of LEV to FPHT was confirmed with p 〈 0.001 by the Farrington-Manning test. No significant differences were observed in the seizure recurrence rate or intubation rate within 24 hours. Serious adverse events developed in three patients in the FPHT group and none in the LEV group (p=0.061). Conclusion The efficacy of LEV was similar to that of FPHT for adult SE following the administration of diazepam. LEV may be recommended as a second-line treatment for SE along with phenytoin/FPHT. Trial registration number jRCTs031190160.
    Type of Medium: Online Resource
    ISSN: 0022-3050 , 1468-330X
    URL: Article
    DOI: 10.1136/jnnp-2022-329485
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 1480429-3
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  • 3
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    Efficacy of pembrolizumab and comprehensive CD274/PD-L1 profiles in patients previously treated with chemoradiation therapy as radical treatment in bladder cancer
    BMJ ; 2022
    In:  Journal for ImmunoTherapy of Cancer Vol. 10, No. 1 ( 2022-01), p. e003868-
    Details
    In: Journal for ImmunoTherapy of Cancer, BMJ, Vol. 10, No. 1 ( 2022-01), p. e003868-
    Abstract: Chemoradiation therapy (CRT) has been increasingly reported as a possible alternative to total cystectomy (TC) for localized bladder cancer (BC). Pembrolizumab is the standard of care for platinum-refractory metastatic urothelial carcinoma, although it is unknown whether the efficacy of pembrolizumab in patients previously treated with curative CRT varies from the results of benchmark trials. Methods We retrospectively assessed whether the survival benefit of pembrolizumab differs between patients previously treated with TC or CRT as radical treatment. A total of 212 patient records were collected for a logistic regression propensity score model. An independent dataset with next-generation sequencing (n=289) and PD-L1 Combined Positive Score (CPS: n=266) was analyzed to assess whether CRT-recurrent tumor harbors distinct CD274/PD-L1 profiles. Results Propensity score matching was performed using putative clinical factors, from which 30 patients in each arm were identified as pair-matched groups. There was no significant difference in overall survival from the initiation of pembrolizumab (p=0.80) and objective response rate (p=0.59) between CRT and TC treatment groups. In the independent 289 BC cohort, 22 samples (7.6%) were collected as CRT-recurrent tumors. There was no significant difference in CD274 mRNA expression level between CRT-naïve and CRT-recurrent tumors. The compositions of CD274 isoforms were comparable among all isoforms detected from RNAseq between CRT-naïve (n=267) and CRT-recurrent (n=22) tumors. No actionable exonic mutation in CD274 was detected in CRT-recurrent tumors. PD-L1 CPS was positively correlated with CD274 mRNA expression level, and PD-L1 CPS was comparable between CRT-naïve and CRT-recurrent tumors. Conclusions The efficacy of pembrolizumab for patients previously treated with CRT was similar to those treated with TC. The enhanced tumor regression by combining programmed cell death protein 1/PD-L1 inhibitor and CRT might be expected only in the concurrent administration.
    Type of Medium: Online Resource
    ISSN: 2051-1426
    URL: Article
    DOI: 10.1136/jitc-2021-003868
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2719863-7
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  • 4
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    Rationale and design for efficacy and safety evaluation of Bone-Anchored Maxillary Protraction (BAMP) for patients with unilateral cleft lip and palate with skeletal anterior crossbite: a single-arm, open-label, non-randomised prospective study protocol
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 9 ( 2022-09), p. e061831-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 9 ( 2022-09), p. e061831-
    Abstract: Bone-anchored maxillary protraction (BAMP) was devised recently as a method of direct maxillary protraction using anchor plates implanted in the maxilla and mandible without involving the teeth. Although several reports have described orthognathic effects of BAMP on patients with cleft lip and palate (CLP) with skeletal crossbite, none has described a study of Japanese patients with CLP or of BAMP treatment effects on speech in patients with CLP. This study, by performing BAMP treatment, and by evaluating speech function and skeletal and soft tissues, is intended to clarify BAMP efficacy and safety for patients with unilateral CLP (UCLP) who have skeletal crossbite. Methods and analysis This single-arm, open-label, non-randomised prospective study examines 20 patients with UCLP with skeletal crossbite (Wits appraisal ≤−5.0 mm). These 10–15 year-old participants had already undergone cheiloplasty, palatoplasty and bone grafting. The anchor plates are implanted in the zygomatic process in the maxilla and in the anterior part of the mandible. Two weeks after anchor plate implantation, maxillary protraction is started using elastics. Protraction is performed at 150 g per side at the start of protraction, 200 g per side from 1 month after the start of protraction and 250 g per side from 3 months after the start of protraction. The treatment period will be approximately 1½ years. Pretreatment and post-treatment, cephalometric analysis, speech evaluation, nasopharyngeal closure function evaluation and facial soft tissue evaluation will be performed to ascertain the effects of BAMP on patients with UCLP. Ethics and dissemination Ethical approval for this study has been received from Tohoku Certificated Review Board of Tohoku University, Japan, CRB2200003. The approval number is 2021-34-2. The results of this research shall be presented at domestic and international academic conferences, and be published to peer-reviewed journals. Trial registration number jRCTs022210007.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2022-061831
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 5
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    Comprehensive and long-term surveys of COVID-19 sequelae in Japan, an ambidirectional multicentre cohort study: study protocol
    BMJ ; 2021
    In:  BMJ Open Respiratory Research Vol. 8, No. 1 ( 2021-11), p. e001015-
    Details
    In: BMJ Open Respiratory Research, BMJ, Vol. 8, No. 1 ( 2021-11), p. e001015-
    Abstract: The rapid spread of COVID-19 posed a global burden. Substantial number of people died of the disease in the acute phase of infection. In addition, a significant proportion of patients have been reported to suffer from post-acute phase symptoms, sequelae of COVID-19, which may negatively influence the quality of daily living and/or socioeconomic circumstances of the patients. However, no previous study has comprehensively and objectively assessed the quality of life of patients by using existing international scales. Further, evidence of socioeconomic consequences among patients with COVID-19 is scarce. To address the multidimensional issues from sequelae of COVID-19, evidence from comprehensive surveys beyond clinical perspectives is critical that investigates health, and social determinants of disease progression as well as socioeconomic consequences at a large scale. Methods and analysis In this study, we plan to conduct a nationwide and comprehensive survey for the sequelae of COVID-19 in a total of 1000 patients diagnosed at 27 hospitals throughout Japan. This study will evaluate not only the health-related status of patients from clinical perspectives but also the Health-related Quality of Life (HRQoL) scores, socioeconomic status and consequences to discuss the sequelae of the disease and the related risk factors. The primary endpoint is the frequency of long-term complications of COVID-19 infection. The secondary endpoints are risk factors for progression to sequelae of COVID-19 infection. The study will provide robust and important evidence as a resource to tackle the issues from the sequelae of COVID-19 from the multi-dimensional perspectives. Ethics and dissemination This trial was approved by the Keio University School of Medicine Ethics Committee (20200243, UMIN000042299). The results of this study will be reported at a society meeting or published in a peer-reviewed journal.
    Type of Medium: Online Resource
    ISSN: 2052-4439
    URL: Article
    DOI: 10.1136/bmjresp-2021-001015
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2736454-9
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  • 6
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    Case of organising pneumonia in HIV infection
    BMJ ; 2022
    In:  BMJ Case Reports Vol. 15, No. 11 ( 2022-11), p. e250544-
    Details
    In: BMJ Case Reports, BMJ, Vol. 15, No. 11 ( 2022-11), p. e250544-
    Abstract: A man in his 50s presented to his doctor with a fever, sore throat, cough, dysgeusia and dyspnoea of several days’ duration. Tests for HIV antigen, HIV antibody and HIV PCR were positive. He was referred to our hospital for initiation of antiretroviral therapy and bronchoscopy to clarify the cause of an abnormal lung shadow on chest CT. He was diagnosed with organising pneumonia, with concurrent HIV infection. His pulmonary lesions were remitted spontaneously, and he was administered a fixed-dose combination of tenofovir (50 mg), emtricitabine (200 mg) and bictegravir (25 mg) for HIV. This is a rare report of organising pneumonia with HIV infection. Physicians need to consider organising pneumonia when lung opacity is observed in a patient with HIV infection.
    Type of Medium: Online Resource
    ISSN: 1757-790X
    URL: Article
    DOI: 10.1136/bcr-2022-250544
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2467301-8
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  • 7
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    Rivaroxaban-related acute kidney injury in a patient with IgA vasculitis
    BMJ ; 2019
    In:  BMJ Case Reports Vol. 12, No. 1 ( 2019-01), p. e227756-
    Details
    In: BMJ Case Reports, BMJ, Vol. 12, No. 1 ( 2019-01), p. e227756-
    Abstract: Anticoagulants have recently been recognised as a cause of acute kidney injury (AKI). We describe the case of a 75-year-old man with IgA vasculitis and atrial fibrillation treated with rivaroxaban, who presented with macroscopic haematuria and an acute decline in renal function. Two months before referral, he noted palpable purpuric lesions and was diagnosed with IgA vasculitis based on skin biopsy findings; the skin lesion disappeared following treatment with a steroid external preparation. Renal biopsy revealed glomerular haemorrhage and red blood cell casts. Although rivaroxaban was withdrawn, his kidney function worsened and he was started on haemodialysis. His renal function did not recover. To the best of our knowledge, this is the first case of direct oral anticoagulant (DOAC)-related AKI in systemic vasculitis. During DOAC therapy, close monitoring of a patient’s urinalysis results and their renal function may be required for patients with systemic vasculitis to avoid AKI.
    Type of Medium: Online Resource
    ISSN: 1757-790X
    URL: Article
    DOI: 10.1136/bcr-2018-227756
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2467301-8
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  • 8
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    Effects of evidence-based ICU care on long-term outcomes of patients with sepsis or septic shock (ILOSS): protocol for a multicentre prospective observational cohort study in Japan
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 3 ( 2022-03), p. e054478-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 3 ( 2022-03), p. e054478-
    Abstract: Sepsis is not only the leading cause of death in the intensive care unit (ICU) but also a major risk factor for physical and cognitive impairment and mental disorders, known as postintensive care syndrome (PICS), reduced health-related quality of life (HRQoL) and even mental health disorders in patient families (PICS-family; PICS-F). The ABCDEF bundle is strongly recommended to overcome them, while the association between implementing the bundle and the long-term outcomes is also unknown. Methods and analysis This is a multicentre prospective observational study at 26 ICUs. All consecutive patients between 1 November 2020 and 30 April 2022, who are 18 years old or older and expected to stay in an ICU for more than 48 hours due to sepsis or septic shock, are enrolled. Follow-up to evaluate survival and PICS/ PICS-F will be performed at 3, 6 and 12 months and additionally every 6 months up to 5 years after hospital discharge. Primary outcomes include survival at 12 months, which is the primary outcome, and the incidence of PICS defined as the presence of any physical impairment, cognitive impairment or mental disorders. PICS assessment scores, HRQoL and employment status are evaluated. The association between the implementation rate for the ABCDEF bundle and for each of the individual elements and long-term outcomes will be evaluated. The PICS-F, defined as the presence of mental disorders, and HRQoL of the family is also assessed. Additional analyses with data up to 5 years follow-up are planned. Ethics and dissemination This study received ethics approvals from Saiseikai Utsunomiya Hospital (2020-42) and all other participating institutions and was registered in the University Hospital Medical Information Network Clinical Trials Registry. Informed consent will be obtained from all patients. The findings will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number UMIN000041433.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2021-054478
    DOI: 10.1136/bmjopen-2021-054478.supp3
    DOI: 10.1136/bmjopen-2021-054478.supp1
    DOI: 10.1136/bmjopen-2021-054478.supp2
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 9
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    Relationship between grip strength during hospitalisation and mental disorders after discharge in critically ill patients: a post-hoc analysis of a prospective observational study
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 5 ( 2023-05), p. e068983-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 5 ( 2023-05), p. e068983-
    Abstract: Post-intensive care syndrome (PICS) is a recognised sequela after critical care. The development of an index that predicts PICS mental disorders will be of significance for the selection of subsequent interventions. The purpose of this study was to find factors associated with PICS mental disorders. We hypothesised that grip strength during hospitalisation may be associated with the PICS mental status after discharge. Design A post-hoc analysis of a multicentre prospective observational study. Setting Nine hospitals in Japan. Participants Patients who were newly admitted to intensive care unit and stayed for at least 48 hours were included. Exclusion criteria were patients younger than 18 years, those who required assistance with ambulation prior to admission, those with concomitant central nervous system disorders and those with terminal conditions. Primary and secondary outcome measures Psychiatric symptoms 3 months after discharge were assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS total score (HADS-total) was assigned as the primary outcome. Results 98 patients were included into this study. Grip strength at discharge negatively correlated with HADS-total 3 months after discharge (r=−0.37, p 〈 0.001, 95% CI −0.53 to −0.18). A multivariate analysis showed that grip strength was associated with anxiety (p=0.025, 95% CI −0.21 to −0.015). Area under the curve for HADS anxiety score with grip strength at discharge was higher than that with Medical Research Council scores and the Barthel Index (0.71, 0.60, 0.61). Conclusions Grip strength at discharge correlated with mental disorders 3 months after discharge. Therefore, it may be useful for predicting postdischarge mental disorders. Trial registration number UMIN000036503.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-068983
    DOI: 10.1136/bmjopen-2022-068983.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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