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Background and Objectives: The global trend toward increased protection of medical personnel from occupational radiation exposure requires efforts to promote protection from radiation on a societal scale. To develop effective educational programs to promote radiation protection, we clarify the actual status and stage of behavioral changes of spine surgeons regarding radiation protection. Materials and Methods: We used a web-based questionnaire to collect information on the actual status of radiation protection and stages of behavioral change according to the transtheoretical model. The survey was administered to all members of the Society for Minimally Invasive Spinal Treatment from 5 October to 5 November 2020. Results: Of 324 members of the Society for Minimally Invasive Spinal Treatment, 229 (70.7%) responded. A total of 217 participants were analyzed, excluding 12 respondents who were not exposed to radiation in daily practice. A trunk lead protector was used by 215 (99%) participants, while 113 (53%) preferred an apron-type protector. Dosimeters, thyroid protector, lead glasses, and lead gloves were used by 108 (50%), 116 (53%), 82 (38%), and 64 (29%) participants, respectively. While 202 (93%) participants avoided continuous irradiation, only 120 (55%) were aware of the source of the radiation when determining their position in the room. Regarding the behavioral change stage of radiation protection, 134 (62%) participants were in the action stage, while 37 (17%) had not even reached the contemplation stage. Conclusions: We found that even among the members of the Society for Minimally Invasive Spinal Treatment, protection of all vulnerable body parts was not fully implemented. Thus, development of educational programs that cover the familiar risks of occupational radiation exposure, basic protection methods in the operating room, and the effects of such protection methods on reducing radiation exposure in actual clinical practice is warranted. [ABSTRACT FROM AUTHOR]

Background: Deep venous thrombosis (DVT) and pulmonary embolism are serious potential complications after anterior cruciate ligament reconstruction (ACLR). Little is known about the influence of tourniquet use on the incidence of DVT after ACLR. Purpose: To compare the incidence of DVT after ACLR with and without the use of a tourniquet. Study Design: Cohort study; Level of evidence, 3. Methods: Between November 2018 and May 2020, a total of 60 consecutive ACLRs in 60 patients, including 7 revision surgeries, were performed without tourniquet use at our hospital and were enrolled in this study (T– group). In addition, 55 consecutive ACLRs in 55 patients, including 10 revision surgeries, were performed with tourniquet use between April 2017 and September 2018 and were enrolled as the control group (T+ group). DVT was diagnosed using ultrasonography of both legs performed preoperatively and at postoperative week 1. The incidence of postoperative DVT was compared between the T– and T+ groups. Logistic regression analysis was performed to evaluate the effect of older age (≥40 vs <40 years) and tourniquet use on the occurrence of DVT. Results: No DVTs were detected preoperatively. The incidence of postoperative DVT was significantly lower in the T– group compared with the T+ group (1 patient [1.7%] vs 9 patients [16.4%]; P =.005). All patients with DVT were asymptomatic. Although the mean operative time was not significantly different (80.8 minutes in the T+ group vs 78.5 minutes in the T– group; P =.461), the mean blood loss from the drain was significantly lower in the T– group than in the T+ group (149.9 vs 201.9 mL; P <.001). Age ≥40 years and tourniquet use were significantly related to the occurrence of DVT (odds ratio, 8.3 [95% CI, 1.9-36.8]; P =.005; and odds ratio, 8.8 [95% CI, 1.0-75.3]; P =.047, respectively). Conclusion: ACLRs performed without tourniquet resulted in a significantly lower incidence of DVT after ACLR and significantly less bleeding from drains. If adequate visibility of the surgical field is obtained, ACLR without tourniquet use may reduce the incidence of DVT. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the association between occupational direct radiation exposure to the hands and longitudinal melanonychia (LM) and hand eczema in spine surgeons. Methods: A web-based questionnaire survey of the Society for Minimally Invasive Spinal Treatment (MIST) in Japan was conducted. The proportion of LM and hand eczema in hands with high and low-radiation exposure was compared using Fisher's exact test. The odds ratios (ORs) and their 95% confidence intervals (CIs) for the prevalence of LM and hand eczema in the high-radiation exposure hands were calculated using generalized estimating equations for logistic regression as control for the correlation of observations among the same individuals and possible confounders. Results: Among 324 members of the society, responses were received from 229 members (70.7%). A total of 454 hands from 227 participants were analysed. The prevalence of LM and hand eczema was 43% and 29%, respectively. In a hand-by-hand comparison, more hands had LM in the high-radiation exposure group than the low-radiation exposure group (90 [40%] vs. 39 [17%], respectively, p < 0.001). A similar trend was observed for hand eczema (63 [28%] vs. 33 [15%], respectively, p = 0.001). The adjusted OR for high-radiation exposure hands was 3.18 (95% CI: 2.24–4.52). Consistent results were obtained for hand eczema, with an adjusted OR of 2.26 (95% CI: 1.67–3.06). Conclusion: The present study suggests that direct radiation exposure to physician's hands is associated with LM and hand eczema. Those with LM and radially biased hand eczema may have had high direct radiation exposure. [ABSTRACT FROM AUTHOR]

Temporal changes in the in situ germination flux of cysts and the abundance of vegetative cells of the toxic dinoflagellate Alexandrium catenella were investigated in Ago Bay, central Japan from July 2003 to December 2004. The in situ germination flux (cells m−2 day−1) was measured using ‘plankton emergence trap/chambers (PET chambers)’. Germination of the cysts in the sediments occurred continuously during the study, ranging from 52 to 1753 cells m−2 day−1, with no temporal trend. This germination pattern appeared to be promoted by a short mandatory dormancy period for newly formed cysts coupled with a broad temperature window for germination. For the vegetative populations, high abundances (>105 cells m−2) were recorded in the water column from spring to summer and from autumn to early winter. The size of the vegetative populations did not correlate with the cyst germination flux but rather larger vegetative populations were often observed when the water temperature was around 20°C, indicating that bloom development was mainly regulated by the temperature. Nonetheless, the continuous germination pattern of A. catenella is advantageous enabling the germinated cells to immediately exploit favorable bloom conditions. [ABSTRACT FROM PUBLISHER]

I shii K.-I., I wataki M., M atsuoka K. and I mai I. 2011. Proposal of identification criteria for resting spores of species (Bacillariophyceae) from a temperate coastal sea. 50: 351--362. DOI: 10.2216/10-36.1 is a large, ecologically important genus of marine planktonic diatoms. Many species of form resting spores to survive environmental stress. Species identification based on morphological characteristics of resting spores is difficult. In the present study, we proposed a flow diagram for the identification of species based on morphology. Resting spores of 18 species were identified in water and sediment samples from southern Japan and the East China Sea based on morphological characteristics of resting spores and/or the vegetative cells containing them. A single ring of puncta was found to be the most important morphological feature of resting spores for species identification, by which the positions of primary and secondary valves were correctly determined. Other morphological characteristics such as features of the primary valve face, margins of the primary and secondary valve mantles, and secondary valve face are also useful for species identification. A combination of these morphological characteristics was used to construct a flow diagram for identification of the 18 species found in our samples with light microscopy. This flow diagram is most applicable to Japanese waters, but the approach should be refined and improved to understand the biology and ecology of species in any marine ecosystem. [ABSTRACT FROM AUTHOR]

• We propose the revision of the infectious disease vaccine clinical trial guidelines. • New vaccines should be evaluated for the protective efficacy with multiregional clinical trials. • In non-major subjects, immunogenicity should be compared with that of main subjects. The development of vaccines against infectious diseases requires a different approach from that of therapeutics, because vaccines are inoculated into healthy individuals and have a preventive effect by activating the immunity of the inoculated human. In Japan, "The Guideline for Clinical Trials of Vaccines for the Prevention of Infectious Diseases" was published in 2010 before changes occurred in the vaccine development environment in Japan, such as the introductions of foreign vaccines and simultaneous global development. This study aimed to identify current challenges in vaccine development through a questionnaire-based survey of pharmaceutical companies in Japan and by comparing the domestic and international guidelines and surveying review reports of 35 vaccines approved in Japan between April 2010 and December 2020. Identified challenges included the requirement for protective efficacy trials, efficacy evaluation of combination vaccines, development of multiregional and foreign clinical trials, and immunization of older adults and immunocompromised patients. We propose that new vaccines against infectious diseases should be evaluated for the protective efficacy, preferably through multiregional clinical trials. Additionally, differences in the incidence of infectious diseases or in epidemic virus strains between regions may affect the trials, when multiregional clinical trials are conducted, but immunogenicity-based studies can be conducted if a correlation between protective efficacy and immunogenicity has been established. We suggest that licensed combination vaccines can be used as comparators when an antigen is added to a licensed combination vaccine. We also proposed that the efficacy of a vaccine in non-major subjects, such as older adults or immunocompromised patients could be evaluated by comparing immunogenicity in major subjects with the confirmed protective effects of the vaccine. It is expected that these revisions will lead to the rapid advancement of vaccine development, which should contribute to the improvement of public health. [ABSTRACT FROM AUTHOR]

• We identified the current challenges in the development of vaccines and propose revision of the guidelines for the non-clinical studies of vaccines. • The results of repeated-dose toxicity studies can be used to decide whether safety pharmacology studies are required. • The studies to evaluate toxicity due to systemic effects may not be necessary for both intramuscular and subcutaneous administration. • Women of childbearing potential could be included in clinical trials with appropriate pregnancy avoidance prior to the reproductive toxicity studies. The efficacy and safety of vaccines for the prevention of infectious diseases are mostly evaluated based on the induction of an immune response against antigens, and do not necessarily depend on the dose administered. Therefore, there are some specific aspects that need to be considered in the development of vaccines and have been described in "The Guidelines for the non-clinical studies of vaccines for the prevention of infectious disease" in Japan. Recent changes in the vaccine development field, such as the introduction of vaccines developed overseas in Japan and vaccine development on a global scale have increased the need for revision of these guidelines. In this study, we identified the current challenges in the development of vaccines through comparison of Japanese and international guidelines. We conducted a questionnaire-based survey of pharmaceutical industries in Japan, and found issues related to non-clinical studies, such as the necessity of safety pharmacology studies and repeated-dose toxicity studies for each route of administration. We examined international guidelines on these issues as well as review reports by regulatory authorities, and determined that the results of repeated-dose toxicity studies can be used to decide whether safety pharmacology studies are required, and that studies to evaluate toxicity due to systemic effects may not be necessary for both intramuscular and subcutaneous administration. We propose revision of the guidelines for the non-clinical studies of vaccines in Japan taking international harmonizaion into account. We expected that the revised guidelines will promote smooth and rational vaccine development. [ABSTRACT FROM AUTHOR]

The preoperative skin antiseptic, olanexidine gluconate (OLG), which has been available in Japan since 2015, is also known to be effective against methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and Pseudomonas aeruginosa. This study attempted to clarify OLG efficacy against surgical site infections and antiseptic-related adverse events as compared to conventionally used povidone iodine (PVP–I). Propensity score matching was performed on 307 patients who underwent surgery for colorectal tumors at our hospital. All 116 cases (58 PVP-I cases, 58 OLG cases) who were diagnosed with colorectal cancer were included. We examined surgical site infection rate after disinfection using PVP-I and OLG, length of hospitalization stay (days) after surgery, adverse events associated with antiseptics, and additional medical costs associated with adverse events caused by antiseptics. The surgical site infection rate was 8.6% in both the PVP-I and OLG groups, with no significant difference observed. The number of postoperative hospitalization days in the PVP-I group was 12.9 (±6.9) days and 16.4 (±14.6) days in the OLG group, which exhibited no significant difference (p = 0.10). Although no complications due to antiseptics were observed in the PVP-I group, skin-related side effects were observed in 8 patients (13.8%) in the OLG group. The median additional medical cost was 730 [120–1823] yen. OLG was as effective as the conventional PVP-I for surgical site infections during colorectal cancer elective surgery. However, significantly higher skin disorders occurred in OLG, thereby making it necessary to evaluate antiseptic use in conjunction with patient burden. [ABSTRACT FROM AUTHOR]

• BK-SE36/CpG is a candidate blood-stage malaria vaccine against P. falciparum. • In healthy Japanese adults, BK-SE36/CpG has an acceptable safety profile. • No indication of autoimmune condition was observed in BK-SE36/CpG vaccinees. • Two dosing, 21-days apart, of full-dose BK-SE36/CpG was highly immunogenic. BK-SE36 is blood-stage malaria vaccine candidate that is undergoing clinical trials. Here, the safety and immunogenicity of BK-SE36 with a novel adjuvant, CpG-ODN(K3) (thus, BK-SE36/CpG) was assessed in a phase 1a trial in Japan. An investigator-initiated, randomised, single-blind, placebo-controlled, dose-escalation study was conducted at Osaka University Hospital with 26 healthy malaria naïve Japanese male adults. The trial was conducted in two stages: Stage/Group 1, half-dose (n = 7 for BK-SE36/CpG and n = 3 for control) and Stage/Group 2, full-dose (n = 11 for BK-SE36/CpG and n = 5 for control). There were two intramuscular vaccinations 21 days apart for both half-dose (0.5 ml: 50 µg SE36 + 500 µg aluminum + 500 µg K3) and full-dose (1.0 ml: 100 µg SE36 + 1000 µg aluminum + 1000 µg K3). A one-year follow-up was done to monitor changes in autoimmune markers and vaccine-induced antibody response. BK-SE36/CpG was well tolerated. Vaccination site reactions were similar to those observed with BK-SE36. During the trial and follow-up period, no subject had clinical evidence of autoimmune disease. The full-dose group had significantly higher titres than the half-dose group (Student's t -test, p = 0.002) at 21 days post-second vaccination. Antibody titres remained above baseline values during 12 months of follow-up. The vaccine induced antibody was mostly composed of IgG1 and IgM, and recognised epitopes close to the polyserine region located in the middle of SE36. BK-SE36/CpG has an acceptable safety profile. Use of CpG-ODN(K3) greatly enhanced immunogenicity in malaria naïve Japanese adults when compared to BK-SE36 alone. The utility of BK-SE36/CpG is currently under evaluation in a malaria endemic setting in West Africa. Trial Registration. JMACCT Clinical Trial Registry JMA-IIA00109. [ABSTRACT FROM AUTHOR]

Strategic Outlook toward 2030: Japan's Research for Allergy and Immunology (Strategy 2030) is the national research strategy based on Japan's Basic Law on Measures Against Allergic Diseases, a first of its kind worldwide. This strategy was established by a multi-disciplinary committee consisting of administrators of the Ministry of Health, Labour and Welfare of Japan, young and senior experts from various research societies and associations, and representatives of patient and public groups. Whereas the issues of transition, integration, and international collaboration have yet to be solved in this research realm in Japan, identification of unmet needs, digitization of information and transparent procedures, and strategic planning for complex problems (a process dubbed MIERUKA by the Toyota Way) are crucial to share and tackle the same vision and goals. The committee developed three specific actions focusing on preemptive treatment, interdisciplinarity and internationality, and life stage. The real success of Strategy 2030 is made by the spontaneous contributions of doctors, dentists, veterinarians, and other medical professionals; basic and clinical research scientists, research supporters, and pharmaceutical/medical device companies; manufacturers of food, healthcare, and home appliances; and patients, their families, and the public. The hope is to establish a stable society in which people can live long, healthy lives, as free as possible from allergic and immunological diseases, at each individual life stage. This article is based on a Japanese review first reported in Arerugi , introduces the developmental process and details of Strategy 2030. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective review of three spine surgery databases.Objectives: The purpose of the present study is to determine whether predictors of hospital readmission and surgical site infection (SSI) after lumbar fusion will be the same in United States, Denmark, and Japan.Summary Of Background Data: Because clinical decision making becomes more data driven, risk stratification will be crucial to minimize complications. Spine surgeons worldwide face this issue, leading to parallel efforts to address risk stratification. This raises the question as to whether pooled data would be valuable and whether models generated in one country would be applicable to other populations.Methods: Predictors of SSI and 30-day readmission from three prospective databases (National Neurosurgery Quality and Outcomes Database [N2QOD] N = 2653, DaneSpine N = 1993, Japan Multicenter Spine Database [JAMSD] N = 3798) were determined and compared to identify common or divergent predictive risks.Results: Predictive variables differed in the three databases, for both readmission and SSI. Factors predictive for hospital readmission were American Society of Anesthesiologists (ASA) grade in N2QOD (P = 0.013, odds ratio [OR] 2.08), fusion levels in DaneSpine (P = 0.005, OR 1.67), and sex in JAMSD (P = 0.001, OR = 2.81). Associated differences in demographics and procedural factors included mean ASA grade (N2QOD = 2.45, JAMSD = 1.72) and fusion levels (N2QOD = 1.39, DaneSpine = 1.52, JAMSD = 1.34). For SSI, sex (P = 0.000, OR = 3.30), diabetes (P = 0.000, OR = 2.90), and length of stay (P = 0.000, OR = 1.02) were predictive in JAMSD. No predictors were identified in N2QOD or DaneSpine.Conclusion: Predictors of SSI and hospital readmission differ in the United States, Denmark, and Japan, suggesting that risk stratification models may need to be population specific or adjusted. Some differences in measured parameters exist in the three databases analyzed; however, patient and procedure selection also appear to differ and may limit the ability to directly pool data from different regions. Therefore, risk stratification models developed in one country may not be directly applicable to other countries.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Background: Ossification of the posterior longitudinal ligament (OPLL) can cause myelopathy that is often managed surgically. Knowledge of predictors of surgical outcomes can provide decision support to surgeons. The aims of this study were to investigate the relationships between preoperative physical signs and postoperative functional outcomes in patients with OPLL and to clarify whether physical signs could predict functional outcomes.Methods: Fifty-five patients with OPLL who had undergone cervical laminoplasty were included in this study. Six physical signs including hyperreflexia, Babinski sign, sensory disturbance, grip strength, 10-s grip and release test, and bladder dysfunction, and four other factors including age, duration of symptoms, history of minor trauma and preoperative Japanese Orthopaedic Association (JOA) score were investigated as potential predictive prognostic factors using both univariate and multivariate analyses.Results: The mean recovery rate of JOA score was 62.5 ± 32.5%. The neurological recovery rate was negatively associated with age (P = 0.002), the duration of symptoms (P = 0.002) and Babinski sign (P = 0.007), whereas it was positively correlated with grip strength (P = 0.011). Multiple logistic regression analyses revealed that age (Odds ratio: 0.89, 95% CI: 0.81-0.99) and Babinski sign (Odds ratio: 0.18, 95% CI: 0.04-0.89) were factors associated with functional outcomes.Conclusions: Satisfactory functional outcomes could be expected for patients who are young and do not exhibit the Babinski sign, showing that the Babinski sign could be useful as an indicator of the window of opportunity for achieving satisfactory functional outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To clarify correlations between spinal fracture and delayed paralysis in patients with diffuse idiopathic skeletal hyperostosis (DISH) using computed tomography (CT) with multiplanar reformatting (CT-MPR). DISH increases susceptibility to unstable spinal fractures, leading to neurological deterioration. The pathomechanism of the neurological injury is unclear.Methods: This multicenter retrospective study included 42 DISH patients (32 male; 10 female) treated for 45 spinal fractures during a 5-year period. The mean age at the time of injury was 77.1 ± 10.1 years. The cause of injury, delay in diagnosis, fracture location, and neurological status were recorded, and anterior- and posterior-column fractures, a fracture displacement over 3 mm, and posterior-column ankylosis were assessed using CT-MPR.Results: Most fractures (73.8%) resulted from trivial trauma, such as falling from a standing or sitting position. Diagnosis was delayed in 47.6% of the patients, primarily due to delays in seeking medical attention (65.0%). Although 78.6% of the patients were neurologically intact at the time of injury, 54.8% developed paralysis, defined by a change in one or more Frankel-score levels during short-term follow-up. Of the fractures, 39.1% were in the vertebral body, and 60.9% were at the disc level. Fractures with posterior-column ankylosis were significantly associated with delayed paralysis.Conclusions: CT-MPR was useful for evaluating spinal fractures and determining treatment in patients with DISH. Fractures associated with posterior-column ankylosis resulted in unstable three-column injuries that led to delayed neurological deterioration. Early surgical stabilization of such fractures is recommended to avoid delayed paralysis. [ABSTRACT FROM AUTHOR]

Background: In Japan, ossification of the posterior longitudinal ligament (OPLL) has been designated as an intractable disease by the Ministry of Health, Labour, and Welfare. Here we aimed to clarify the epidemiological characteristics of severe OPLL patients by analyzing a national registry of this disease that uses clinical investigation registration forms.Methods: We retrospectively investigated clinical investigation registration forms for 24,502 patients with OPLL. We examined the sex distribution, age of disease onset, period from disease onset to registration, family history, site of ossification as determined by plain radiographs, Japanese Orthopaedic Association score, and number of OPLL surgeries.Results: The male-to-female ratios were 2.7:1 and 1.9:1 for new and renewed registrations, respectively. The mean ages at disease onset were 61.1 and 59.7 years for new and renewed registrations, respectively. The mean periods from disease onset to registration were 2.6 and 8.4 years for new and renewed registrations, respectively. The percentages of new registrations with and without family history were 5.3% and 51.5%, respectively (unknown for 43.3%). Of the new registrations, 3511, 359, and 200 cases exhibited ossification in the cervical spine, thoracic spine, and lumbar spine, respectively; the corresponding numbers for renewed registrations were 13,710, 2484, and 1508. The Japanese Orthopaedic Association score was 9.9 ± 3.6 for new registrations, and the mean score recovery rate for renewed registrations was 6.0%. The number of OPLL surgeries was one or zero, two, three, four, or five for 21,785, 2167, 412, 99, and 39 patients, respectively, with 11.1% of all patients having undergone multiple surgeries.Conclusions: This study offers new insight into the epidemiological characteristics of severe OPLL. In particular, we found that the age of disease onset was higher than previously reported, the period from disease onset to registration (surgery) was relatively short, and about 90% of the patients required only a single surgery. [ABSTRACT FROM AUTHOR]

Background: Although various risk factors have been reported for adjacent segment degeneration after lumbar fusion, the exact mechanisms and risk factors related to adjacent segment degeneration have not been clear. The present study was conducted to evaluate the risk factors for radiological adjacent segment degeneration in patients surgically treated for single-level L4 spondylolisthesis focusing on a single pathology, a specific fusion level, at a set interval. Methods: We assessed preoperative and five-year postoperative radiographs for 72 patients who underwent L4-5 anterior or posterior lumbar interbody fusion for single-level L4 degenerative spondylolisthesis. Adjacent segment degeneration was defined as imaging evidence of one or more of the following conditions at L1-2, L2-3, or L3-4: 1) a loss of more than 20% of the preoperative disc height, 2) anterolisthesis or retrolisthesis greater than 3 mm, 3) or osteophyte formation greater than 3 mm. Results: We found adjacent segment degeneration in 21 patients, with 31 discs affected. Multiple logistic regression analysis identified the following significant independent risk factors for adjacent segment degeneration: female gender (odds ratio 10.80; 95% confidence interval 1.20-96.89), posterior lumbar interbody fusion (odds ratio 7.70; 95% confidence interval 1.82-32.66), and pre-existing disc degeneration (odds ratio 12.29; 95% confidence interval 1.69-89.27). Conclusions: Female gender, posterior lumbar interbody fusion, and pre-existing disc degeneration were significant independent risk factors for radiologically diagnosed adjacent segment degeneration in patients treated for L4 degenerative spondylolisthesis by interbody lumbar fusion. [ABSTRACT FROM AUTHOR]

Abstract: Alum-adjuvanted H5 whole virion inactivated vaccine (WIV) was licensed for adults in Japan but induced marked febrile reactions with significantly stronger antibody responses in children. In this study, the mechanisms behind the different responses were investigated. Lymphocytes were obtained from 25 healthy subjects who were not immunized with H5 vaccine, to examine the innate immune impact of the various vaccine formulations, analyzing the cytokine production profile stimulated with alum adjuvant alone, alum-adjuvanted H5 WIIV, plain H5 WIV, and H5 split vaccine. Alum adjuvant did not induce cytokine production, but H5 split induced IFN-γ and TNF-α. H5 WIV induced IL-6, IL-17, TNF-α, MCP-1, IFN-γ, and IFN-α. An extremely low level of IL-1β was produced in response to H5 WIV, and alum-adjuvanted H5 WIV enhanced IL-1β production, with similar levels of other cytokines stimulated with H5 WIV. Enhanced production of cytokines induced by alum-adjuvanted H5 WIV may be related to the higher incidence of febrile reactions with stronger immune responses in children but it should be further investigated why efficient immune responses with febrile illness were observed only in young children. [Copyright &y& Elsevier]

Background and Aims: This study evaluated the impact of the coronavirus disease 2019 (COVID-19) pandemic on pancreatic adenocarcinoma (PA) practice in our region and discussed the effects of our institution's regional collaborative system, the "Early Stage Pancreatic Cancer Diagnosis Project," which was originally unrelated to this study's purpose., Methods: We retrospectively investigated 150 patients with PA at Yokohama Rosai Hospital by defining three time periods: before (C0), during the first year (C1), and during the second year (C2) of the COVID-19 pandemic., Results: Among the three periods (C0, C1, and C2), there were significantly less patients with stage I PA (14.0%, 0%, and 7.4%, p = 0.032) in C1, and significantly more patients with stage III PA (10.0%, 28.3%, and 9.3%, p = 0.014) in C1. The pandemic significantly prolonged the median durations from disease onset to patients' first visits (28, 49, and 14 days, p = 0.012). In contrast, there was no significant difference in the median durations from referral to first visit to our institution (4, 4, and 6 days, p = 0.391)., Conclusions: The pandemic advanced the stage of PA in our region. Although the pancreatic referral network remained functional during the pandemic, there were delays from disease onset to patients' first visit to healthcare providers, including clinics. While the pandemic caused temporary damage to PA practice, the routine regional collaboration provided by our institution's project allowed for early resilience. A notable limitation is that the impact of the pandemic on PA prognosis was not evaluated., Competing Interests: Conflict of interest disclosure The authors declare no conflicts of interest associated with this study and received no funding or financial support for its conduct., (Copyright © 2023 IAP and EPC. Published by Elsevier B.V. All rights reserved.)

Background: The optimal treatment of osteoporosis after reconstruction surgery for osteoporotic vertebral fractures (OVF) remains unclear. In this multicentre retrospective study, we investigated the effects of typically used agents for osteoporosis, namely, bisphosphonates (BP) and teriparatide (TP), on surgical results in patients with osteoporotic vertebral fractures., Methods: Retrospectively registered data were collected from 27 universities and affiliated hospitals in Japan. We compared the effects of BP vs TP on postoperative mechanical complication rates, implant-related reoperation rates, and clinical outcomes in patients who underwent posterior instrumented fusion for OVF. Data were analysed according to whether the osteoporosis was primary or glucocorticoid-induced., Results: A total of 159 patients who underwent posterior instrumented fusion for OVF were included. The overall mechanical complication rate was significantly lower in the TP group than in the BP group (BP vs TP: 73.1% vs 58.2%, p = 0.045). The screw backout rate was significantly lower and the rates of new vertebral fractures and pseudoarthrosis tended to be lower in the TP group than in the BP group. However, there were no significant differences in lumbar functional scores and visual analogue scale pain scores or in implant-related reoperation rates between the two groups. The incidence of pseudoarthrosis was significantly higher in patients with glucocorticoid-induced osteoporosis (GIOP) than in those with primary osteoporosis; however, the pseudoarthrosis rate was reduced by using TP. The use of TP also tended to reduce the overall mechanical complication rate in both primary osteoporosis and GIOP., Conclusions: The overall mechanical complication rate was lower in patients who received TP than in those who received a BP postoperatively, regardless of type of osteoporosis. The incidence of pseudoarthrosis was significantly higher in patients with GIOP, but the use of TP reduced the rate of pseudoarthrosis in GIOP patients. The use of TP was effective to reduce postoperative complications for OVF patients treated with posterior fusion.

Goal: The goal of this study was to investigate the relationship between Helicobacter pylori (H. pylori) infection and short-segment and long-segment Barrett's esophagus (SSBE and LSBE)., Background: H. pylori infection is reported to be inversely associated with Barrett's esophagus (BE) in western countries. However, the impact of BE segment length on the association between BE and H. pylori infection has scarcely been investigated., Materials and Methods: The study subjects were 41,065 asymptomatic Japanese individuals who took medical surveys between October 2010 and September 2017. Using this large database of healthy Japanese subjects, we investigated the association between H. pylori infection and SSBE/LSBE. We used multivariable logistic regression analysis to estimate odds ratios (ORs) and 95% confidence intervals (CIs)., Results: Among the study subjects, 36,615 were eligible for the analysis. H. pylori seropositivity was significantly associated with a lower rate of LSBE (OR: 0.42; 95% CI: 0.16-0.91) and a higher rate of SSBE (OR: 1.66; 95% CI: 1.56-1.78) after multivariate adjustment. In the subgroup analysis, H. pylori seropositivity was significantly associated with a high rate of SSBE in subjects without reflux esophagitis (RE) (OR: 1.73; 95% CI: 1.61-1.85). However, H. pylori seropositivity was not associated with SSBE in subjects with RE (OR: 1.07; 95% CI: 0.84-1.37)., Conclusion: In a Japanese population, H. pylori infection was inversely associated with LSBE but significantly associated with SSBE only in subjects without RE. H. pylori may be a risk factor for SSBE, especially in individuals without RE.

Background: There have been few reports on the incidence and risk factors of the complications after spinal fixation surgery for osteoporotic vertebral collapse (OVC) with neurological deficits. This study aimed to identify the incidence and risk factors of the complications after OVC surgery., Methods: In this retrospective multicenter study, a total of 403 patients (314 women and 89 men; mean age 73.8 years) who underwent spinal fixation surgery for OVC with neurological deficits between 2005 and 2014 were enrolled. Data on patient demographics were collected, including age, sex, body mass index, smoking, steroid use, medical comorbidities, and surgical procedures. All postoperative complications that occurred within 6 weeks were recorded. Patients were classified into two groups, namely, complication group and no complication group, and risk factors for postoperative complications were investigated by univariate and multivariate analyses., Results: Postoperative complications occurred in 57 patients (14.1%), and the most common complication was delirium (5.7%). In the univariate analysis, the complication group was found to be older (p = 0.039) and predominantly male (p = 0.049), with higher occurrence rate of liver disease (p = 0.001) and Parkinson's disease (p = 0.039) compared with the no-complication group. In the multivariate analysis, the significant independent risk factors were age (p = 0.021; odds ratio [OR] 1.051, 95% confidence interval [CI] 1.007-1.097), liver disease (p < 0.001; OR 8.993, 95% CI 2.882-28.065), and Parkinson's disease (p = 0.009; OR 3.636, 95% CI 1.378-9.599)., Conclusions: Complications after spinal fixation surgery for OVC with neurological deficits occurred in 14.1%. Age, liver disease, and Parkinson's disease were demonstrated to be independent risk factors for postoperative complications., (Copyright © 2019 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)

Study Design: A retrospective study., Objective: To identify the radiographic differences between Chinese and Japanese patients with cervical ossification of the posterior longitudinal ligament (OPLL) using computed tomography (CT) and magnetic resonance imaging (MRI), and to compare the characteristics of OPLL between the two nationalities., Summary of Background Data: OPLL has a high prevalence in East Asia. However, the differences between Chinese and Japanese OPLL patients are poorly known., Methods: This was a retrospective study of Chinese (n = 300) and Japanese (n = 102) consecutive patients who received a diagnosis of cervical OPLL between January 2010 and December 2014. All patients underwent CT and MRI. The type and distribution of OPLL were determined. Spinal compression was assessed by MRI. OPLL type, distribution, comorbidity, and compression of the spinal cord were examined. The ossification index (OP-index) was used to evaluate the OPLL. Factors contributing to the OP-index were examined by multivariate analysis., Results: The Chinese patients were younger than the Japanese patients (P < 0.0001), and there were more women among the Chinese patients (P = 0.0002). The OP-index was higher among the Japanese patients (median, 5 vs. 4, P = 0.003). Among men, OPLL lesions were more frequent in the under 55-year-old Japanese at C7 (P = 0.04), in the 55 to 64-year-old Japanese at C4, C5, and C6 (all P < 0.05), and in the over 64-year-old Japanese at C3/4 (P = 0.01), compared with their Chinese counterparts. Among women, OPLL lesions were more frequent in the 55 to 64-year-old Japanese at C6 (P = 0.04). The multivariate analysis showed that only age was independently associated with the OP-index (odds ratio [OR] = 1.023, 95% confidence interval [CI]: 1.002-1.045, P = 0.034)., Conclusion: Japanese patients had a higher frequency of OPLL lesions at C5, C6, and C7. Age was independently associated with OPLL., Level of Evidence: 3.