Efficacy and safety of lascufloxacin for nursing- and healthcare-associated pneumonia: A single-arm, open-label clinical trial.

BACKGROUND: Nursing- and healthcare-associated pneumonia (NHCAP) constitutes most of the pneumonia in elderly patients including aspiration pneumonia in Japan. Lascufloxacin (LSFX) possesses broad antibacterial activity against respiratory pathogens, such as Streptococcus spp. And anaerobes inside the oral cavity. However, the efficacy and safety of LSFX in NHCAP treatment remains unknown. We aimed to evaluate the efficacy and safety of LSFX tablets in the treatment of patients with NHCAP. METHODS: In this single-arm, open-label, uncontrolled study, LSFX was administered to patients with NHCAP at 24 facilities. The study participants were orally administered 75 mg LSFX once daily for 7 days. The primary endpoint was the clinical efficacy at the time of test of cure (TOC). The secondary endpoints included clinical efficacy at the time of end of treatment (EOT), early clinical efficacy, microbiological efficacy, and safety analysis. RESULT: During the study period, 75 patients provided written informed consent to participate and were included. Finally, 56 and 71 patients were eligible for clinical efficacy and safety analyses, respectively. The median age of the patients was significantly high at 86 years. All patients were classified as having moderate disease severity using the A-DROP scoring system. LSFX tablets demonstrated high efficacy rates of 78.6 % at TOC and 89.3 % at EOT. The risk factors for resistant bacteria or aspiration pneumonia did not affect clinical efficacy. No severe adverse events associated with the study drugs were observed. CONCLUSION: Oral LSFX is an acceptable treatment option for moderate NHCAP in elderly patients who can take oral medications.

Effectiveness of Messenger RNA Coronavirus Disease 2019 Vaccines Against Symptomatic Severe Acute Respiratory Syndrome Coronavirus 2 Infections During the Delta Variant Epidemic in Japan: Vaccine Effectiveness Real-time Surveillance for SARS-CoV-2 (VERSUS).

BACKGROUND: Although high vaccine effectiveness of messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines has been reported in studies in several countries, data are limited from Asian countries, especially against the Delta (B.1.617.2) variant. METHODS: We conducted a multicenter test-negative case-control study in patients aged ≥16 years visiting hospitals or clinics with signs or symptoms consistent with COVID-19 from 1 July to 30 September 2021, when the Delta variant was dominant (≥90% of SARS-CoV-2 infections) nationwide in Japan. Vaccine effectiveness of BNT162b2 or mRNA-1273 against symptomatic SARS-CoV-2 infections was evaluated. Waning immunity among patients aged 16-64 years was also assessed. RESULTS: We enrolled 1936 patients, including 396 test-positive cases and 1540 test-negative controls for SARS-CoV-2. The median age was 49 years, 53.4% were male, and 34.0% had underlying medical conditions. Full vaccination (receiving 2 doses ≥14 days before symptom onset) was received by 6.6% of cases and 38.8% of controls. Vaccine effectiveness of full vaccination against symptomatic SARS-CoV-2 infections was 88.7% (95% confidence interval [CI], 78.8%-93.9%) among patients aged 16-64 years and 90.3% (95% CI, 73.6%-96.4%) among patients aged ≥65 years. Among patients aged 16-64 years, vaccine effectiveness was 91.8% (95% CI, 80.3%-96.6%) within 1-3 months after full vaccination, and 86.4% (95% CI, 56.9%-95.7%) within 4-6 months. CONCLUSIONS: mRNA COVID-19 vaccines had high effectiveness against symptomatic SARS-CoV-2 infections in Japan during July-September 2021, when the Delta variant was dominant nationwide.

Hospitalists' COVID-19 management roles in hospitals without infectious disease specialists.

BACKGROUND: Hospitalists may work in a variety of clinical settings to manage COVID-19 cases. However, the extent of their involvement in COVID-19 care is unknown, particularly in hospitals without infectious disease (ID) specialists. METHODS: This study aimed to confirm whether hospitalists provided COVID-19 management in various clinical settings when ID specialists were unavailable. We conducted a multicenter cross-sectional study using a web-based questionnaire. The participants were full-time hospitalists working in Japanese academic community-based hospitals. The study period was from 15 January 2021 to 15 February 2021, during Japan's third wave of the COVID-19 pandemic. The primary outcome was the rate of hospitalists participating in COVID-19 inpatient management in hospitals with or without ID specialists. RESULTS: ID specialists were absent in 31% of small hospitals (those with fewer than 249 registered beds), but only 4% of large hospitals (p < 0.001). Hospitalists were more likely to manage both COVID-19 inpatient care and emergency department care in hospitals without than with hospitals with ID specialists (76 versus 56% (p = 0.01) and 90 versus 73% (p = 0.01), respectively). After adjusting for confounders by multivariate analysis, hospitalists who worked in hospitals without ID specialists had higher odds of participating in COVID-19 inpatient care than those who worked in hospitals with such specialists (adjusted odds ratio: 3.0, 95% CI: 1.2-7.4). CONCLUSION: Hospitalists were more likely to provide COVID-19 inpatient care in various clinical settings in hospitals without ID specialists.

Diagnostic Dilemma of Syncope: Esophageal Hiatal Hernia and High-risk Bundle-branch Block.

We herein report a complicated case of recurrent syncope accompanying bundle branch block and hiatal hernia of the esophagus. An 83-year-old woman presented with syncope. Echocardiography visualized the left atrium compressed by an esophageal hiatal hernia, which had potential to decrease the cardiac output. Although she underwent esophageal repair surgery, two months after the surgery, she presented to the emergency department again with complaints of syncope. At the return visit, her face was pale and her pulse rate was 30 beats per minute. Electrocardiography showed complete atrioventricular block. On reviewing the patient's previous electrocardiography findings, we found a record of trifascicular block. This case illustrates the importance of predicting atrioventricular blocks in patients with high-risk bundle-branch blocks. Keeping in mind high-risk bundle-branch blocks will help clinicians avoid anchoring bias due to a striking image masquerading as the true diagnosis.

"Diagnose, Treat, and SUPPORT". Clinical competencies in the management of older adults with aspiration pneumonia: a scoping review.

BACKGROUND: Aspiration pneumonia in older adults is increasingly common, with a high care burden and morbidity. However, clinical competencies in its management have not been developed, and healthcare professionals struggle on how to care for these patients with multimodal treatment needs. Therefore, we conducted a scoping review to investigate what is known about the desired clinical competencies for the management of older adults with aspiration pneumonia, to utilise in clinical practice, education, and future research. METHODS: First, we defined aspiration pneumonia according to a preliminary search. We then searched the literature on MEDLINE and CINAHL, focusing on studies involving patients aged 65 years old and older diagnosed with aspiration pneumonia. All settings were included, with the exception of intensive care units. Publication dates were limited to January 2011 to July 2022 and languages to English and Japanese. The extracted data were used to refine the preliminary competency framework developed by the Japan Aspiration pneumonia inter-Professional team Educational Program (JAPEP) in preparation of this study. RESULTS: Ninety-nine studies were included. Following data extraction from these studies, 3 competencies were renamed, and 3 new competencies were added, to create a list of 12 competencies. These were Diagnosis, Treatment, Swallow Assessment, Underlying condition management, Nutrition, Oral management, Rehabilitation, Multidisciplinary team, Decision making, Prevention, Prognosis, and Palliative care. CONCLUSIONS: Our scoping review identified 12 clinical competencies required in the management of older adults with aspiration pneumonia, outlined in the phrase 'Diagnose, Treat and SUPPORT'. We encourage healthcare professionals to share these competencies as a team to identify areas of unmet need and improve their patient care, with an emphasis on supportive care.

Lack of Physician-Dentist Collaboration in Aspiration Pneumonia Prevention.

This opinion paper addresses the challenges and future directions for preventing aspiration pneumonia in Japan's rapidly aging population. It highlights the increasing proportion of elderly individuals and the associated rise in health issues like decreased swallowing function, a risk factor for aspiration pneumonia. The paper emphasizes the effectiveness of dentist-provided oral care in preventing this condition but notes the lack of collaboration between dentists and physicians in Japan's clinical practice. Key challenges identified include the scarcity of full-time hospital dentists, insufficient communication between physicians and dentists, limited patient understanding and motivation regarding oral care, and a lack of training in geriatric dentistry. The paper advocates for enhanced awareness among healthcare professionals and patients, increased hospital dentists, and improved collaboration mechanisms, particularly in light of recent positive changes in insurance reimbursement policies for elderly oral care.

Effect of poor oral health status at hospital admission on in-hospital outcomes of older patients with aspiration pneumonia.

PURPOSE: To investigate the effects of oral health status at admission on in-hospital outcomes and how it varies during hospitalization in older patients with aspiration pneumonia. METHODS: This prospective cohort study involved patients aged ≥ 65 years who were admitted to an acute care hospital with a diagnosis of aspiration pneumonia. The patients' basic health information, length of hospital stay (LOS), and oral health assessment tool (OHAT), functional oral intake scale (FOIS), pneumonia severity index, and clinical frailty scale scores were recorded. Patients were divided into two groups based on their median OHAT scores, and intergroup changes were analyzed as a function of time. The relationship between the LOS, FOIS score upon discharge, and OHAT scores at admission was examined using multiple regression analysis. RESULTS: Of the 89 participants (52 were men, with a mean age of 84.8 ± 7.9 years), 75 were discharged. The patients' oral health was measured weekly for 3 weeks after the initial assessment via the OHAT, wherein the median score was 7, with a significant between-group difference. Moreover, OHAT scores improved within both groups throughout their stay. OHAT scores at admission were independently associated with the LOS (B = 5.51, P = 0.009). CONCLUSION: Poor oral health status at admission was associated with longer hospital stays. Both the high- and low-OHAT groups showed OHAT score improvements. Oral health status is critical in preventing the onset of and treating aspiration pneumonia.

Dental Care to Reduce Aspiration Pneumonia Recurrence: A Prospective Cohort Study.

BACKGROUND: Aspiration pneumonia has a high recurrence rate, and oral care by dentists has been found effective in preventing its onset; however, this has not been evaluated using prospective studies. Therefore, we conducted a prospective study to evaluate the effectiveness of professional oral care by dentists in reducing aspiration pneumonia recurrence in older adult patients. METHODS: In this prospective cohort study, we evaluated a dental oral care intervention, using a historical control group (control group). It was conducted at a single-centre regional core hospital in Japan that serves a large number of patients aged older than 80 years. Patients who were hospitalised for aspiration pneumonia were included in this study. During the study period (1 April 2021 to 31 March 2022), the clinical group received weekly professional cleaning by a dentist and the control group received standard oral care by a nurse as usual from 1 April 2020 to 31 March 2021. The dentist oral care group received weekly professional oral care from a dentist and was followed prospectively for 1 year. A Kaplan-Meier analysis was used to evaluate the timing of recurrent aspiration pneumonia or death. A Cox proportional hazards model was used to obtain a hazard ratio and determine the 95% confidence intervals. RESULTS: There were 91 participants in the clinical group and 94 in the control group. The mean age of participants was 85 years, and 75 (40.5%) were female. The recurrence rate was 27.5% in the clinical group and 44.7% in the control group (P = .005). Professional cleaning by a dentist reduced the risk of recurrence of aspiration pneumonia by approximately 50% (adjusted hazard ratio, 0.465; 95% confidence interval, 0.278-0.78). CONCLUSIONS: Professional cleaning by a dentist was associated with a lower rate of aspiration pneumonia recurrence than nurse-provided conventional oral care.

Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study.

INTRODUCTION: Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms. METHODS AND ANALYSIS: We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients' hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions. ETHICS AND DISSEMINATION: The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings. TRIAL REGISTRATION NUMBER: NCT05913700.

Effectiveness of primary series, first, and second booster vaccination of monovalent mRNA COVID-19 vaccines against symptomatic SARS-CoV-2 infections and severe diseases during the SARS-CoV-2 omicron BA.5 epidemic in Japan: vaccine effectiveness real-time surveillance for SARS-CoV-2 (VERSUS).

BACKGROUND: This study aimed to evaluate VE of primary, first, and second booster ancestral-strain monovalent mRNA COVID-19 vaccination against symptomatic infections and severe diseases in Japan. METHODS: We conducted a test-negative case-control study. We included medically attended episodes and hospitalizations involving individuals aged ≥16 with signs and symptoms from July to November 2022, when Omicron BA.5 was dominant nationwide. To evaluate VE, we calculated adjusted ORs of vaccination among test-positive versus test-negative individuals using a mixed-effects logistic regression. RESULTS: For VE against symptomatic infections among individuals aged 16 to 59, VE of primary vaccination at > 180 days was 26.1% (95% CI: 10.6-38.8%); VE of the first booster was 58.5% (48.4-66.7%) at ≤90 days, decreasing to 41.1% (29.5-50.8%) at 91 to 180 days. For individuals aged ≥60, VE of the first booster was 42.8% (1.7-66.7%) at ≤90 days, dropping to 15.4% (-25.9-43.2%) at 91 to 180 days, and then increasing to 44.0% (16.4-62.5%) after the second booster. For VE against severe diseases, VE of the first and second booster was 77.3% (61.2-86.7%) at ≤90 days and 55.9% (23.4-74.6%) afterward. CONCLUSION: mRNA booster vaccination provided moderate protection against symptomatic infections and high-level protection against severe diseases during the BA.5 epidemic in Japan.

Evaluation of ChatGPT-Generated Differential Diagnosis for Common Diseases With Atypical Presentation: Descriptive Research.

Background: The persistence of diagnostic errors, despite advances in medical knowledge and diagnostics, highlights the importance of understanding atypical disease presentations and their contribution to mortality and morbidity. Artificial intelligence (AI), particularly generative pre-trained transformers like GPT-4, holds promise for improving diagnostic accuracy, but requires further exploration in handling atypical presentations. Objective: This study aimed to assess the diagnostic accuracy of ChatGPT in generating differential diagnoses for atypical presentations of common diseases, with a focus on the model's reliance on patient history during the diagnostic process. Methods: We used 25 clinical vignettes from the Journal of Generalist Medicine characterizing atypical manifestations of common diseases. Two general medicine physicians categorized the cases based on atypicality. ChatGPT was then used to generate differential diagnoses based on the clinical information provided. The concordance between AI-generated and final diagnoses was measured, with a focus on the top-ranked disease (top 1) and the top 5 differential diagnoses (top 5). Results: ChatGPT's diagnostic accuracy decreased with an increase in atypical presentation. For category 1 (C1) cases, the concordance rates were 17% (n=1) for the top 1 and 67% (n=4) for the top 5. Categories 3 (C3) and 4 (C4) showed a 0% concordance for top 1 and markedly lower rates for the top 5, indicating difficulties in handling highly atypical cases. The χ2 test revealed no significant difference in the top 1 differential diagnosis accuracy between less atypical (C1+C2) and more atypical (C3+C4) groups (χ²1=2.07; n=25; P=.13). However, a significant difference was found in the top 5 analyses, with less atypical cases showing higher accuracy (χ²1=4.01; n=25; P=.048). Conclusions: ChatGPT-4 demonstrates potential as an auxiliary tool for diagnosing typical and mildly atypical presentations of common diseases. However, its performance declines with greater atypicality. The study findings underscore the need for AI systems to encompass a broader range of linguistic capabilities, cultural understanding, and diverse clinical scenarios to improve diagnostic utility in real-world settings.

Effectiveness of mRNA COVID-19 vaccines against symptomatic SARS-CoV-2 infections during the SARS-CoV-2 Omicron BA.1 and BA.2 epidemic in Japan: vaccine effectiveness real-time surveillance for SARS-CoV-2 (VERSUS).

BACKGROUND: Evaluating COVID-19 vaccine effectiveness (VE) domestically is crucial for assessing and determining national vaccination policy. This study aimed to evaluate VE of mRNA COVID-19 vaccines in Japan. METHODS: We conducted a multicenter test-negative case-control study. The study comprised individuals aged ≥16 visiting medical facilities with COVID-19-related signs or symptoms from 1 January to 26 June 2022, when Omicron BA.1 and BA.2 were dominant nationwide. We evaluated VE of primary and booster vaccination against symptomatic SARS-CoV-2 infections and relative VE of booster compared with primary. RESULTS: We enrolled 7,931 episodes, including 3,055 test positive. The median age was 39, 48.0% were male, and 20.5% had underlying medical conditions. In individuals aged 16 to 64, VE of primary vaccination within 90 days was 35.6% (95% CI, 19.0-48.8%). After booster, VE increased to 68.7% (60.6-75.1%). In individuals aged ≥65, VE of primary and booster was 31.2% (-44.0-67.1%) and 76.5% (46.7-89.7%), respectively. Relative VE of booster compared with primary vaccination was 52.9% (41.0-62.5%) in individuals aged 16 to 64 and 65.9% (35.7-81.9%) in individuals aged ≥65. CONCLUSIONS: During BA.1 and BA.2 epidemic in Japan, mRNA COVID-19 primary vaccination provided modest protection. Booster vaccination was necessary to protect against symptomatic infections.

Effectiveness of a computerized clinical decision support system for prevention of glucocorticoid-induced osteoporosis.

Glucocorticoids are widely used for a variety of diseases, but the prevention of glucocorticoid-induced osteoporosis is sometimes neglected. Therefore, the effectiveness of a computerized clinical decision support system (CDSS) to improve the performance rate of preventive care for glucocorticoid-induced osteoporosis was evaluated. We conducted a prospective cohort study of outpatients who used glucocorticoids for three months or longer and who met the indication for preventive care based on a guideline. The CDSS recommended bisphosphonate (BP) prescription and bone mineral density (BMD) testing based on the risk of osteoporosis. The observation period was one year (phase 1: October 2017-September 2018) before implementation and the following one year (phase 2: October 2018-September 2019) after implementation of the CDSS. Potential alerts were collected without displaying them during phase 1, and the alerts were displayed during phase 2. We measured BP prescriptions and BMD testing for long-term prescription of glucocorticoids. A total of 938 patients (phase 1, 457 patients; phase 2, 481 patients) were included, and the baseline characteristics were similar between the phases. The median age was 71 years, and men accounted for 51%. The primary disease for prescription of glucocorticoids was rheumatic disease (28%), followed by hematologic diseases (18%). The prevalence of patients who needed an alert for BP prescription (67% vs. 63%, P = 0.24) and the acceptance rate of BP prescription (16% vs. 19%, P = 0.33) were similar between the phases. The number of patients who had orders for BMD testing was significantly increased (4% vs. 24%, P < 0.001) after CDSS implementation. The number of patients who needed an alert for BMD testing was significantly decreased from 93% in phase 1 to 87% in phase 2 (P = 0.004). In conclusion, the CDSS significantly increased BMD testing in patients with a higher risk of glucocorticoid-induced osteoporosis, but did not increase BP prescription.