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Thrombosis in myeloproliferative neoplasms (MPNs) is an important clinical problem, and risk-stratified management is essential. To identify the clinical characteristics of thrombosis in patients with MPNs, a nationwide multi-institutional retrospective analysis (JSH-MPN-R18) was conducted. The aim of the present study was to perform a sub-analysis of JSH-MPN-R18 findings to clarify the predictive parameters for thrombosis among complete blood count (CBC) results. Among the patients enrolled in JSH-MPN-R18, those with essential thrombocythemia (ET; n = 1152) and polycythemia vera (PV; n = 456) were investigated. We analyzed and compared CBC parameters between patients with and those without any thrombotic events using Welch's T-test. Statistical analyses were performed using the R statistical software. Thrombotic events were observed in 74 patients with ET. In multivariate analysis, only the neutrophil ratio was slightly but significantly higher for ET patients with thrombosis than for those without (p < 0.05). Of note, the absolute neutrophil count (aNeu) was considered a useful predictive tool for thrombosis among patients classified as low-risk according to the revised International Prognostic Score of Thrombosis for Essential Thrombocythemia. Among PV patients, those with thrombosis showed significantly higher hematocrit and aNeu than did those without thrombosis. As a thrombosis-associated factor, the neutrophil ratio was slightly but significantly elevated in patients with ET. This myeloid skew might reflect a higher value of JAK2 V617F allelic frequency in patients with ET with thrombosis; this was not clarified in JSH-MPN-R18. Further accumulation of evidence, including genetic information for JAK2 and other passenger mutations, is warranted.
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Many effective new agents for relapsed childhood acute lymphoblastic leukemia (ALL) are now becoming available, and international standard chemotherapy should be developed to optimize use of these agents. Randomized controlled trials (RCTs) are needed to establish a standard treatment, but few have been conducted for relapsed childhood ALL in Japan due to the small patient population. Participation in international RCTs is necessary to access sufficient patients for informative study results, but differences in approved drugs and healthcare systems between countries make this challenging. In 2014, the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) participated in an international study on standard-risk relapsed childhood ALL (IntReALL SR 2010) involving two RCTs and multiple drugs not approved in Japan, which was addressed by replacing the unapproved drugs with alternative approved drugs with the same or similar efficacy. This article discusses the historical background of treatment development for relapsed childhood ALL, our experience in participating in the IntReALL SR 2010 trial, and prospects for treating relapsed childhood ALL.
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Leucemia-Linfoma Linfoblástico de Células Precursoras , Recidiva , Humanos , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Criança , Japão , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
Humanness perception, which attributes fundamental and unique human characteristics to other objects or people, has significant consequences for people's interactions. Notably, the failure to perceive humanness in older adults can lead to prejudice. This study investigates the effect of a target's age on humanness perception in terms of two dimensions: agency (the ability to act and do) and experience (the ability to feel and sense). We also examined brain activity using a magnetic resonance imaging (MRI) scanner in order to understand the underlying neural mechanisms. Healthy university students viewed the facial images of older and younger individuals and judged the humanness of each individual in terms of agency and experience while inside the MRI scanner. The results indicated that older adults were rated higher on experience, and no difference was found in ratings for agency between younger and older face images. Analysis of brain imaging data indicated that positive functional connectivity between the ventral and dorsal regions of the medial prefrontal cortex (mPFC) was greater when judging the humanness of younger faces than older faces. We also found that the negative functional connectivity between the left inferior frontal gyrus and postcentral gyrus was greater when judging the humanness of older faces as compared to that of younger faces. Although the current study did not show distinct brain activities related to humanness perception, it suggests the possibility that different brain connectivities are related to humanness perception regarding targets belonging to different age groups.
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The emergence of novel drugs has significantly improved outcomes of patients with plasma cell neoplasms (PCN). The Japanese Society of Hematology conducted a prospective observational study in newly diagnosed PCN patients between 2016 and 2021. The analysis focused on 1385 patients diagnosed with symptomatic PCN between 2016 and 2018. The primary endpoint was the 3-year overall survival (OS) rate among patients requiring treatment (n = 1284), which was 70.0% (95%CI 67.4-72.6%). Approximately 94% of these patients received novel drugs as frontline therapy. The 3-year OS rate was 90.3% (95%CI 86.6-93.1%) in the 25% of patients who received upfront autologous stem cell transplantation (ASCT), versus just 61.4% (95%CI 58.0-64.6%) in those who did not receive upfront ASCT. The only unfavorable prognostic factor that affected OS in ASCT recipients was an age of 65 or higher. For patients who did not receive ASCT, independent unfavorable prognostic factors included frontline treatment with conventional chemotherapies, international staging system score of 2/3, extramedullary tumors, and Freiberg comorbidity index of 2/3. This study unequivocally demonstrates that use of novel drugs improved OS in Japanese myeloma patients, and underscores the continued importance of upfront ASCT as the standard of care in the era of novel drugs.
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Neoplasias de Plasmócitos , Humanos , Estudos Prospectivos , Idoso , Feminino , Pessoa de Meia-Idade , Masculino , Japão , Neoplasias de Plasmócitos/terapia , Transplante Autólogo , Prognóstico , Taxa de Sobrevida , Adulto , Transplante de Células-Tronco Hematopoéticas , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Mieloma Múltiplo/terapia , Mieloma Múltiplo/mortalidade , Mieloma Múltiplo/tratamento farmacológico , População do Leste AsiáticoRESUMO
The Japanese Society of Hematology performed an observational cross-sectional study to clarify the morbidity, prognosis, and prognostic factors in patients with COVID-19 with hematological diseases (HDs) in Japan. The study included patients with HDs who enrolled in our epidemiological survey and had a COVID-19 diagnosis and a verified outcome of up to 2 months. The primary endpoints were characteristics and short-term prognosis of COVID-19 in patients with HDs. A total of 367 patients from 68 institutes were enrolled over 1 year, and the collected data were analyzed. The median follow-up among survivors was 73 days (range, 1-639 days). The 60-day overall survival (OS) rate was 86.6%. In the multivariate analysis, albumin ≤ 3.3 g/dL and a need for oxygen were independently associated with inferior 60-day OS rates (hazard ratio [HR] 4.026, 95% confidence interval (CI) 1.954-8.294 and HR 14.55, 95% CI 3.378-62.64, respectively), whereas 60-day survival was significantly greater in patients with benign rather than malignant disease (HR 0.095, 95% CI 0.012-0.750). Together, these data suggest that intensive treatment may be necessary for patients with COVID-19 with malignant HDs who have low albumin levels and require oxygen at the time of diagnosis.
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COVID-19 , Doenças Hematológicas , Humanos , Japão/epidemiologia , Estudos Transversais , COVID-19/epidemiologia , Teste para COVID-19 , Prognóstico , Doenças Hematológicas/epidemiologia , Albuminas , Oxigênio , Estudos RetrospectivosRESUMO
BACKGROUND: Cognitive functions decline with age. Declined cognitive functions negatively affect daily behaviors. Previous studies showed the positive effect of spices and herbs on cognition. In this study, we investigated the positive impact of wasabi, which is a traditional Japanese spice, on cognitive functions. The main bioactive compound of wasabi is 6-MSITC (6 methylsulfinyl hexyl isothiocyanate), which has anti-oxidant and anti-inflammatory functions. Anti-oxidants and anti-inflammatories have an important role in cognitive health. Therefore, 6-MSITC is expected to have positive effects on cognitive function. Previous studies showed the beneficial effects on cognitive functions in middle-aged adults. However, it is unclear that 6-MSITC has a positive effect on cognitive functions in healthy older adults aged 60 years and over. Here, we investigated whether 12 weeks' 6-MSITC intervention enhances cognitive performance in older adults using a double-blinded randomized controlled trial (RCT). METHODS: Seventy-two older adults were randomly assigned to 6-MSITC or placebo groups. Participants were asked to take a supplement (6-MSITC or a placebo) for 12 weeks. We checked a wide range of cognitive performances (e.g., executive function, episodic memory, processing speed, working memory, and attention) at the pre- and post-intervention periods. RESULTS: The 6-MSITC group showed a significant improvement in working and episodic memory performances compared to the placebo group. However, we did not find any significant improvements in other cognitive domains. DISCUSSION: This study firstly demonstrates scientific evidence that 6-MSITC may enhance working memory and episodic memory in older adults. We discuss the potential mechanism for improving cognitive functions after 6-MSITC intake.
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Cognição , Memória Episódica , Pessoa de Meia-Idade , Humanos , Idoso , Função Executiva , Isotiocianatos/farmacologia , Isotiocianatos/uso terapêuticoRESUMO
Introduction: Coping with mortality threat, a psychological threat unique to humans and distinct from general emotional distress, is traditionally characterized by immediate suppression and prolonged worldview defense within the framework of the influential terror management theory (TMT). Views regarding the personality-trait concepts for this coping capacity diverge: some favor a broad definition based on general psychological attitudes (e.g., hardiness), while others prefer a narrow definition linked to interpersonal attitudes related to social coalition (e.g., attachment style and self-transcendence). Methods: Using functional MRI, we presented healthy older participants with death-related words and explored correlations between the neural responses to mortality threat and the factor scores of the Power to Live questionnaire, which measures eight resilience-related psychobehavioral traits. Results: We observed a significant association between the factor score and a neural response only for leadership; individuals with a high leadership score exhibited reduced neural response to mortality salience in the right inferior parietal lobule. Discussion: Within the TMT framework, our findings align with the concept of the immediate suppression of death-thought accessibility associated with a secure attachment style, a trait conceptually linked to leadership. These findings highlight the unique role for the narrowly defined social-coalitional trait during the immediate stage of the coping process with mortality salience, in contrast to the broadly defined resilience-related personality traits associated with a prolonged worldview defense process. The deterioration of this coping process could constitute a distinct aspect of psychopathology, separate from dysfunction in general emotion regulation.
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The COVID-19 pandemic is a global public health crisis. Although it has been expected that the vaccination of COVID-19 mitigates the crisis, some people are reluctant to receive the COVID-19 vaccination. Based on the theory of mental simulation and affective forecasting, we investigated how mental simulations influence COVID-19 vaccination intention. Three preregistered experiments were conducted (total n = 970). Experiment 1 tested for whether outcome (vs. process) simulation would increase COVID-19 vaccination intention. Experiment 2 explored whether temporal proximity of simulations (distant-future outcome, near-future outcome, process) modulate the effects of mental simulation on expected emotion and COVID-19 vaccination intention. Experiment 3 examined the role of the number of sensory modalities (multisensory, unisensory) in mental simulations. The result of Experiment 1 (n = 271) demonstrated that outcome (vs. process) simulation of the COVID-19 vaccination led to greater COVID-19 vaccination intention. The result of Experiment 2 (n = 227) revealed that distant-future outcome simulation (vs. near-future outcome simulation, process simulation) increased expected positivity and then enhanced COVID-19 vaccination intention. The result of Experiment 3 (n = 472) also demonstrated that distant-future outcome simulation (vs. near-future outcome simulation, process simulation) increased expected positivity and then enhanced COVID-19 vaccination intention regardless of the number of sensory modalities to be simulated. Our findings reveal how mental simulations influence COVID-19 vaccination intention and provide practical implications for effective health communication strategies for the COVID-19 vaccination intention. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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Vacinas contra COVID-19 , COVID-19 , Humanos , Pandemias , COVID-19/prevenção & controle , Emoções , Intenção , VacinaçãoRESUMO
The expression spectra of connexin (Cx) isoforms were investigated in three mouse melanoma cell lines: B16-F1 (F1), B16-F10 (F10), and B16-BL6 (BL6). Metastatic potential intensity was higher in the order of F1, F10, and BL6. A remarkable behavior of Cx45 was found among 20 isoforms. The expression level of Cx45 was highest in F1 and lowest in BL6. It was inductively predicted that Cx45 might be a novel suppressor of metastasis. A Cx45-overexpressing BL6 cell line (Cx45 +BL6) was developed and its properties were compared with those of a wild-type cell line of BL6 (W-BL6). Compared to W-BL6, Cx45 +BL6 showed reduced wound healing, Transwell® permeability, and matrix metalloproteinase 9 expression, suggesting the suppression of cellular migration and invasion. The expression of E-cadherin and integrin ß1 in Cx45 +BL6 was also lower than in W-BL6, suggesting reduced cell adhesion. The decrease in cell adhesion was supported by the cell washing-out assay. In contrast, no difference between W-BL6 and Cx45 +BL6 was observed in cell proliferation, suggesting no effect on cell-cycle regulating factors. Finally, an in vivo assay revealed a significant decrease in the number of metastatic colonies of Cx45 +BL6 (176 ± 25/lung) in comparison with those of W-BL6 (252 ± 23/lung) in a mouse model. In conclusion, Cx45 is a novel suppressor of melanoma metastasis. Supplementary Information: The online version contains supplementary material available at 10.1007/s10616-022-00563-x.
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In the wake of the global pandemic, interacting with others while wearing masks has emerged as a global challenge. A growing body of literature has reported that face masks hinder emotion recognition in Western populations. Given that diagnostic facial features for recognizing specific emotions (e.g., happiness) differ between Western and Eastern cultures, there may be cultural differences in the effects of face masks on emotion recognition. Relying on the previous findings showing cultural differences in emotion recognition, we conducted a preregistered study where 203 American and 209 Japanese participants judged the emotional expressions of faces (happy, fearful, angry, sad, disgust, and neutral) with and without masks. The results showed cultural differences in emotion recognition of faces with and without masks. Specifically, face masks decreased the accuracy of happy emotion recognition in the Americans but not in the Japanese. The results suggest that the effect of wearing masks on emotion recognition depends on the types of emotions and culture and supports previous findings indicating cultural differences in the decoding strategy for facial expressions. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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Asco , Emoções , Humanos , Felicidade , Ira , Medo , Expressão FacialRESUMO
STUDY DESIGN: Retrospective cohort study. OBJECTIVES: The aim was to examine cervical spinal cord compression (SCC) in adult scoliosis and clarify the prevalence of and risk factors for cervical SCC. METHODS: This study included 270 adult scoliosis patients and 1211 healthy volunteers. Cervical SCC was evaluated on cervical magnetic resonance imaging (MRI). The rates of SCC for those with adult scoliosis and the healthy volunteers were compared. Logistic regression analysis was conducted to examine the factors associated with cervical SCC on MRI. RESULTS: In cases with adult scoliosis, preoperative major scoliosis curve was 56.0° ± 18.8°, and cervical SCC was detected in 25 patients (9.3%). Among the healthy volunteers, 64 cases with cervical SCC were detected. Only in cases with adult scoliosis, logistic regression analysis revealed higher age (OR 1.09, 95% CI 1.04-1.14, P < .001), narrow canal diameter (OR 2.27, 95% CI 1.35-3.85, P = .002), and inferior sagittal balance (OR 2.45, 95% CI 1.02-5.89, P = .04) as significant risk factors. In the logistic regression analysis in all subjects (including adult scoliosis and healthy volunteers), higher age (OR 1.08, 95% CI 1.06-1.10, P < .001) and narrow canal diameter (OR 1.62, 95% CI 1.37-1.92, P < .001) were also found to be significant risk factors, but the presence of scoliosis was not a significant factor. CONCLUSIONS: Adult scoliosis itself was not significantly associated with cervical SCC. Inferior sagittal balance in addition to scoliosis constituted a significant risk factor for cervical SCC.
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BACKGROUND: Cancer chemotherapy indications for patients with poor performance status and advanced lung cancer are limited. Molecular targeted drugs, including epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors, can be used in patients with poor performance status owing to their high efficacy and safety. The third-generation EGFR-tyrosine kinase inhibitor osimertinib has demonstrated effectiveness in the initial treatment of advanced EGFR mutation-positive non-small cell lung cancer in patients with good performance status; however, no evidence exists of the drug's effectiveness in patients with poor performance status in a prospective study. We designed a study that aims to investigate the efficacy and safety of first-line osimertinib treatment in patients with advanced non-small cell lung cancer harboring sensitive EGFR mutations and with poor performance status. METHODS: The OPEN/TORG2040 study is a multicenter, single-arm, phase II trial for patients with unresectable, advanced EGFR mutation-positive non-small cell lung cancer with a poor performance status (≥ 2). Eligible patients will receive osimertinib until disease progression or unacceptable toxicity. The primary endpoint is the objective response rate of the first-line osimertinib treatment. Considering a threshold value of 45%, expected value of 70% for objective response rate, one-sided significance level of 5%, statistical power of 80%, and ineligible patients, the sample size was set to 30. The secondary endpoints are disease control rate, performance status improvement rate, and safety and patient-reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Quality of Life Questionnaire and Lung Cancer 13. Time to treatment failure, progression-free survival, and overall survival will also be assessed. DISCUSSION: Our study can determine the clinical benefits of osimertinib treatment in patients with poor performance status, since the clinical outcomes of patients with EGFR mutation-positive non-small cell lung cancer with poor performance status treated with this drug as a first-line treatment have not been sufficiently evaluated. TRIAL REGISTRATION: Japan Registry of Clinical Trials: jRCTs041200100 (registration date: February 12, 2021).
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/genética , Estudos Prospectivos , Qualidade de Vida , Receptores ErbB , Compostos de Anilina , Mutação , Inibidores de Proteínas Quinases/farmacologia , Ensaios Clínicos Fase II como Assunto , Estudos Multicêntricos como AssuntoRESUMO
The presence of a JAK2 V617F or JAK2 exon 12 mutation is one of the three major criteria listed for the diagnosis of polycythemia vera (PV) in the 2017 World Health Organization Classification. However, a nationwide study has not yet been conducted in Japan since the discovery of JAK2 mutations. Therefore, the Japanese Society of Hematology (JSH) retrospectively analyzed the clinical characteristics of 596 Japanese patients with PV diagnosed between April 2005 and March 2018. Among the 473 patients with complete data on JAK2 mutations available, 446 (94.3%) and 10 (2.1%) were positive for the JAK2 V617F and JAK2 exon 12 mutations, respectively. During a median follow-up of 46 months (range: 0-179 months), 47 (7.9%) deaths occurred. The major causes of death were secondary malignancies (23.4%), acute leukemia (12.8%), non-leukemic progressive disease (10.6%) and thrombotic (6.4%) and hemorrhagic complications (6.4%). Thrombotic and hemorrhagic events occurred during the clinical course in 4.0% (n = 24) and 3.5% (n = 21) of patients, respectively. These results show that the international PV prognostic score (age, venous thrombosis and leukocytosis) is applicable to Japanese patients with PV.
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Hematologia , Policitemia Vera , Trombose , Humanos , Policitemia Vera/complicações , Japão/epidemiologia , Janus Quinase 2/genética , Estudos Retrospectivos , Trombose/etiologia , MutaçãoRESUMO
Appropriate emotion regulation is crucially involved in mental and physical health. The neural basis of negative but not positive emotion regulation has been well investigated. Several strategies should be compared to elucidate the neural correlates of positive emotion regulation. However, there are no studies on multiple positive emotion regulation strategies. We aimed to investigate the neural correlates of positive emotion regulation with multiple emotion regulation strategies and identify common and differential brain areas involved in positive emotion upregulation. We acquired functional magnetic resonance imaging data from healthy college student volunteers while they upregulated positive emotions through instructed strategies or by viewing positive pictures. The instructed strategies included Attentional Deployment, Cognitive Change, and Response Modulation. These strategies increased subjective positive emotions and activation of the prefrontal cortex (PFC) and anterior cingulate cortex (ACC). Region of interest analysis revealed greater activation of the ventral striatum during positive emotion regulation. There are different networks involved in Cognitive Change and Response Modulation. Our findings indicate that multiple strategies for positive emotion upregulation involve common (e.g., PFC, ACC, and ventral striatum) and unique networks.
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Mapeamento Encefálico , Regulação Emocional , Encéfalo/diagnóstico por imagem , Mapeamento Encefálico/métodos , Emoções/fisiologia , Humanos , Imageamento por Ressonância Magnética/métodosRESUMO
Submitting data compliant with the Clinical Data Interchange Standards Consortium (CDISC) standards is mandatory for new drug applications (NDAs). The standards set by CDISC are widely adopted in the pharmaceutical business world. Introduction of CDISC standards in academia can be necessary to reduce labor, resolve the shortage of data managers in academia, and gain new knowledge through standardized data accumulation. However, the introduction of CDISC standards has not progressed in communities within the academia that do not apply for NDAs. Therefore, herein, we created study data tabulation model (SDTM)-compliant datasets within the academia, without outsourcing, to reduce costs associated with investigator-initiated clinical trials. First, we input data from paper case report forms (CRFs) into an electronic data capture system with minimal function for paper CRFs, "Ptosh," which is compatible with SDTM. Then, we developed a generic program to convert data exported from Ptosh into fully SDTM-compliant datasets. The consistency was then verified with an SDTM validator, Pinnacle21 Community V3.0.1 (P21C). This resulted in generation of SDTM datasets, resolving all "Rejects" in P21C, thereby achieving the required quality level. Although Ptosh directly exports data in SDTM format, manual mapping of items on CRFs to SDTM variables prepared in Ptosh is necessary. SDTM mapping requires extensive knowledge and skills, and it was assumed that mapping is challenging for the staff without in-depth knowledge of CDISC standards and datasets. Therefore, for CDISC dissemination in academia, it is crucial to secure the staff, time, and funding to acquire the knowledge.
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This study aimed both to evaluate rib cage parameters in patients with adolescent idiopathic scoliosis (AIS) by three-dimensional (3D) image reconstruction using biplanar stereoradiography (EOS) (EOS Imaging, Paris, France) and identify factors associated with postoperative pulmonary function deterioration (PFD). A total of 67 patients with Lenke type 1 or 2 AIS (59 females and 8 males; mean age, 14.4 years) undergoing posterior corrective fusion with a rod rotation maneuver based on segmental pedicle screw fixation were recruited. 3D images and pulmonary function test results were analyzed preoperatively and at 2 years postoperatively. The following parameters were measured: maximum thickness, maximum width, thoracic index, rib hump, rib cage volume (RCV), spinal penetration index (SPI), endothoracic hump ratio (EHR), vertebra-sternum angle (VSA), rib-vertebra angle difference, vertebral lateral decentering (VLD), forced vital capacity (FVC), and percent predicted FVC (%FVC). PFD was defined as a postoperative %FVC decline of 5% or greater. Patients were divided into two groups, namely PFD and non-PFD. FVC increased from 2.62 L to 2.73 L, while %FVC decreased from 88.7% to 82.7%. The maximum width diminished postoperatively in the PFD group. Patients in the PFD group exhibited a significantly smaller increase in RCV and VLD as well as a significantly smaller decrease in SPI, EHR, and VSA than those in the non-PFD group. The rib cage parameters quantified on 3D images reconstructed using EOS are useful in identifying factors affecting PFD in patients with AIS.
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Cifose , Escoliose , Fusão Vertebral , Adolescente , Feminino , Humanos , Imageamento Tridimensional/métodos , Masculino , Estudos Prospectivos , Caixa Torácica , Escoliose/complicações , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Vértebras Torácicas/cirurgiaRESUMO
BACKGROUND: Real-world data (RWD) and real-world evidence (RWE) are playing increasingly important roles in clinical research and health care decision-making. To leverage RWD and generate reliable RWE, data should be well defined and structured in a way that is semantically interoperable and consistent across stakeholders. The adoption of data standards is one of the cornerstones supporting high-quality evidence for the development of clinical medicine and therapeutics. Clinical Data Interchange Standards Consortium (CDISC) data standards are mature, globally recognized, and heavily used by the pharmaceutical industry for regulatory submissions. The CDISC RWD Connect Initiative aims to better understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance needed to more easily implement them. OBJECTIVE: The aim of this study is to understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance that may be needed to implement CDISC standards more easily for this purpose. METHODS: We conducted a qualitative Delphi survey involving an expert advisory board with multiple key stakeholders, with 3 rounds of input and review. RESULTS: Overall, 66 experts participated in round 1, 56 in round 2, and 49 in round 3 of the Delphi survey. Their inputs were collected and analyzed, culminating in group statements. It was widely agreed that the standardization of RWD is highly necessary, and the primary focus should be on its ability to improve data sharing and the quality of RWE. The priorities for RWD standardization included electronic health records, such as data shared using Health Level 7 Fast Health care Interoperability Resources (FHIR), and the data stemming from observational studies. With different standardization efforts already underway in these areas, a gap analysis should be performed to identify the areas where synergies and efficiencies are possible and then collaborate with stakeholders to create or extend existing mappings between CDISC and other standards, controlled terminologies, and models to represent data originating across different sources. CONCLUSIONS: There are many ongoing data standardization efforts around human health data-related activities, each with different definitions, levels of granularity, and purpose. Among these, CDISC has been successful in standardizing clinical trial-based data for regulation worldwide. However, the complexity of the CDISC standards and the fact that they were developed for different purposes, combined with the lack of awareness and incentives to use a new standard and insufficient training and implementation support, are significant barriers to setting up the use of CDISC standards for RWD. The collection and dissemination of use cases, development of tools and support systems for the RWD community, and collaboration with other standards development organizations are potential steps forward. Using CDISC will help link clinical trial data and RWD and promote innovation in health data science.
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Animacy perception-discriminating between animate and inanimate visual stimuli-is the basis for engaging in social cognition and for our survival (e.g., avoiding potential danger). Previous studies indicate that factors in a target, such as the features or motion of a target, enhance animacy perception. However, factors in a perceiver, such as the visual attention of a perceiver to a target, have received little attention from researchers. Research on judgment, decision-making, and neuroeconomics indicates the active role of visual attention in constructing decisions. This study examined the role of visual attention in the perception of animacy by manipulating the exposure time of targets. Among Studies 1a to 1c conducted in this study, participants saw two face illustrations alternately; one of the faces was shown to be longer than the other. The participants chose the face that they considered more animated and rounder. Consequently, longer exposure time toward targets facilitated animacy perception and preference rather than the perception of roundness. Furthermore, preregistered Study 2 examined the underlying mechanisms. The results suggest that mere exposure, rather than orienting behavior, might play a vital role in the perception of animacy. Thus, in the reverse relationship between visual attention and animacy perception, animate objects capture attention-attention results in the perception of animacy.
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We conducted a large-scale, nationwide retrospective study of Japanese patients who were diagnosed with essential thrombocythemia based on the diagnostic criteria in the World Health Organization classification. We investigated clinical characteristics, survival rates, and the incidence of thrombohemorrhagic events as well as risk factors for these events. A total of 1152 patients were analyzed in the present study. Median age at diagnosis was 65 years, the median platelet count was 832 × 109/L, and the positive mutation rates of JAK2V617F, CALR, and MPL were 62.8, 25.1, and 4.1%, respectively. Compared with European and American patients, Japanese patients were more likely to have cardiovascular risk factors and less likely to have systemic symptoms including palpable splenomegaly. Thrombocytosis was identified as a risk factor for hemorrhagic events and prognosis, but not for thrombotic events. The prognostic factors and risk classifications reported in Europe and the United States were generally applicable to Japanese patients. Regarding transformations, secondary myelofibrosis progressed in a time-dependent manner, but progression to acute leukemia was low in "true" ET patients. Skin cancers were less common and gastrointestinal cancers more common as secondary malignancies in Japanese patients, suggesting ethnic differences.
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Trombocitemia Essencial/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Análise de Sobrevida , Trombocitemia Essencial/complicações , Trombocitemia Essencial/epidemiologia , Adulto JovemRESUMO
STUDY DESIGN: Multicenter, retrospective cohort study. OBJECTIVE: The aim of this study was to investigate the occurrence and surgical predictors of postoperative shoulder imbalance (PSI) in Lenke type 2A adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Although several studies have investigated the factors influencing PSI in Lenke type 2 curves, no studies have analyzed PSI-related factors considering upper instrumented vertebra (UIV) and lumbar modifier type simultaneously. METHODS: Patients with Lenke Type 2A AIS treated by spinal fusion were retrospectively identified and their data were extracted from six spine centers in Japan. Inclusion criteria were age between 10 and 20âyears at surgery, UIVâ=âT2, major curve 40° to 90°, and follow-up for 24 to 30âmonths after surgery. We analyzed patient characteristics, surgical characteristics, and preoperative and immediate-postoperative radiographic parameters. We defined patients with lower instrumented vertebra (LIV) equal or proximal to the last touching vertebra (LTV) as selective thoracic fusion (STF-LTV) and patients with LIV distal to the LTV as non-STF-LTV. t Tests, Mann-Whitney U test, χ2 tests, Fisher exact tests, and multivariate logistic regression were used for statistical analyses. RESULTS: Among the 99 consecutive patients with a mean follow-up of 25.6âmonths, PSI was seen in 27 (27.3%) patients immediately after and in 17 (17.2%) patients at 24 to 30âmonths. The univariate analysis revealed that the significant risk factors of PSI were preoperative radiographical shoulder height, non-STF-LTV, and high main thoracic curve (MTC) correction (immediate-postoperative MTC correction rate: ≥70%), with PSI incidence of 40.0%. The multivariate logistic regression analysis indicated that interaction term of non-STF-LTV and high MTC correction was an independent risk factor for PSI (non-STF-LTV and high MTC correction, odds ratio: 5.167, 95% confidence interval: 1.470-18.159, Pâ=â0.010). CONCLUSION: To prevent PSI in Lenke Type 2A AIS patients, surgeons should avoid the combination of non-STF-LTV and high MTC correction in those surgeries with UIV as T2.Level of Evidence: 4.