RESUMEN
BACKGROUND: Pocock-Simon's minimisation method has been widely used to balance treatment assignments across prognostic factors in randomised controlled trials (RCTs). Previous studies focusing on the survival outcomes have demonstrated that the conservativeness of asymptotic tests without adjusting for stratification factors, as well as the inflated type I error rate of adjusted asymptotic tests conducted in a small sample of patients, can be relaxed using re-randomisation tests. Although several RCTs using minimisation have suggested the presence of non-proportional hazards (non-PH) effects, the application of re-randomisation tests has been limited to the log-rank test and Cox PH models, which may result in diminished statistical power when confronted with non-PH scenarios. To address this issue, we proposed two re-randomisation tests based on a maximum combination of weighted log-rank tests (MaxCombo test) and the difference in restricted mean survival time (dRMST) up to a fixed time point τ , both of which can be extended to adjust for randomisation stratification factors. METHODS: We compared the performance of asymptotic and re-randomisation tests using the MaxCombo test, dRMST, log-rank test, and Cox PH models, assuming various non-PH situations for RCTs using minimisation, with total sample sizes of 50, 100, and 500 at a 1:1 allocation ratio. We mainly considered null, and alternative scenarios featuring delayed, crossing, and diminishing treatment effects. RESULTS: Across all examined null scenarios, re-randomisation tests maintained the type I error rates at the nominal level. Conversely, unadjusted asymptotic tests indicated excessive conservatism, while adjusted asymptotic tests in both the Cox PH models and dRMST indicated inflated type I error rates for total sample sizes of 50. The stratified MaxCombo-based re-randomisation test consistently exhibited robust power across all examined scenarios. CONCLUSIONS: The re-randomisation test is a useful alternative in non-PH situations for RCTs with minimisation using the stratified MaxCombo test, suggesting its robust power in various scenarios.
Asunto(s)
Modelos de Riesgos Proporcionales , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Proyectos de Investigación/estadística & datos numéricos , Análisis de Supervivencia , Modelos Estadísticos , Interpretación Estadística de DatosRESUMEN
STUDY DESIGN: Retrospective multicenter study. OBJECTIVES: To identify the usefulness of the baseline severity of myelopathy for predicting surgical outcomes for cervical spondylotic myelopathy (CSM). SETTING: Seventeen institutions in Japan. METHODS: This study included 675 persons with CSM who underwent posterior decompression. According to baseline severity, the individuals were divided into the mild (Japanese Orthopaedic Association [JOA] score ≥ 14.5), moderate (JOA score = 10.5-14), and severe (JOA score ≤ 10) groups. Surgical outcomes and clinical variables were compared between the groups. Logistic regression analysis was used to develop a prediction model for unsatisfactory symptom state (postoperative JOA score ≤ 14, residual moderate or severe myelopathy). RESULTS: The mean (±standard deviation) age was 67 ± 12 years. The participants in the severe group were older than those in the mild group. Postoperative JOA scores were higher in the mild group than in the severe group. According to multivariate logistic regression analysis, the prediction model included preoperative JOA scores (odds ratio [OR] 0.60; 95% confidence interval [CI] 0.55-0.67) and age (OR 1.06, 95% CI 1.04-1.08). On the basis of the model, a representative combination of the thresholds to maximize the value of "sensitivity - (1 - specificity)" demonstrated a preoperative JOA score of 11.5 as a predictor of postoperative unsatisfactory symptom state in people around the mean age of the study cohort (67 years). CONCLUSIONS: The combination of the baseline severity of myelopathy and age can predict postoperative symptom states after posterior decompression surgery for CSM.
Asunto(s)
Enfermedades de la Médula Espinal , Traumatismos de la Médula Espinal , Espondilosis , Anciano , Vértebras Cervicales/cirugía , Niño , Descompresión Quirúrgica , Humanos , Estudios Retrospectivos , Enfermedades de la Médula Espinal/cirugía , Espondilosis/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVE: Liquid-based cytology has replaced conventional cytology in cervical cancer screening in many countries. However, a detailed comparison of liquid-based cytology with conventional cytology has not been reported in Japan. Therefore, the aim of the study is to evaluate efficacy of liquid-based cytology in Japan. METHODS: We first evaluated the prevalence of use of liquid-based cytology and then examined the efficacy of liquid-based cytology and conventional cytology for detecting CIN and the rate of unsatisfactory specimens using data from cancer screening collected by the Japanese Cancer Society from FY2011 to FY2014. A Poisson regression model with random effects analyses was used to classify histological outcomes and unsatisfactory specimens using liquid-based cytology compared to conventional cytology. RESULTS: A total of 3 815 131 women were analyzed in the study. The rate of liquid-based cytology increased from approximately 8% in FY2011 to 37% in FY2014. Compared to conventional cytology, the detection rates with liquid-based cytology were significantly higher (1.42 times) for CIN1+ [detection rate ratio (DRR) = 1.42, 95% confidence interval (CI) 1.35-1.48, P < 0.001] and CIN2+ (DRR = 1.16, 95% CI 1.08-1.25, P < 0.001). Positive predictive value ratios of CIN1+ and CIN2+ were also significantly higher for liquid-based cytology than for conventional cytology. However, there was no significant difference between liquid-based cytology and conventional cytology for detection rates and positive predictive values of CIN3+ and cancer. The rate of unsatisfactory specimens was significantly lower with liquid-based cytology compared to conventional cytology (DRR = 0.07, 95% CI 0.05-0.09, P < 0.001). CONCLUSIONS: In order to avoid the unsatisfactory specimens in cervical cancer screening, the results of this study did indicate that liquid-based cytology was more useful than conventional cytology in practical standpoints.
Asunto(s)
Citodiagnóstico/métodos , Detección Precoz del Cáncer/métodos , Displasia del Cuello del Útero/diagnóstico , Neoplasias del Cuello Uterino/diagnóstico , Frotis Vaginal/métodos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Japón , Persona de Mediana Edad , Infecciones por Papillomavirus/patología , Sensibilidad y Especificidad , Adulto JovenRESUMEN
With the rising numbers of patients infected with severe acute respiratory syndrome coronavirus 2, long coronavirus disease 2019 (COVID-19)-a sequelae of COVID-19-has become a major problem. Different sexes and age groups develop different long COVID symptoms, and the risk factors for long COVID remain unclear. Therefore, we performed subgroup analyses of patients with COVID-19, classifying them into different groups. In this multicenter cohort study, using an original questionnaire, we examined patients (≥18 years old) diagnosed with COVID-19 from November 2020 to March 2022 and hospitalized at participating medical facilities. In total, 1066 patients were registered (361 female, 620 male). Hypertension was the most common comorbidity (n = 344; 32.5%). Females with hypertension were significantly less likely to develop long COVID symptoms than those without hypertension (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.27-0.98; p = 0.043). In females, Ca channel blocker administration, rather than having hypertension, was significantly associated with reductions in the frequency of alopecia (OR 0.14, 95% CI 0.03-0.67, p = 0.015), memory impairment (OR 0.14, 95% CI 0.02-0.82, p = 0.029), sleeping disorders (OR 0.17, 95% CI 0.04-0.67, p = 0.012), tinnitus (OR 0.23, 95% CI 0.05-0.98, p = 0.047), sputum (OR 0.31, 95% CI 0.10-0.92, p = 0.035), and fever (OR 0.33, 95% CI 0.12-0.93, p = 0.036). Several long COVID symptoms, including alopecia, were significantly negatively associated with Ca channel-blocker administration in female patients with long COVID. Calcium channel blockers may reduce the development of long COVID in females.
Asunto(s)
COVID-19 , Hipertensión , Humanos , Masculino , Femenino , Adolescente , Bloqueadores de los Canales de Calcio/farmacología , Bloqueadores de los Canales de Calcio/uso terapéutico , Antihipertensivos/uso terapéutico , Síndrome Post Agudo de COVID-19 , Estudios de Cohortes , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Hipertensión/inducido químicamente , Alopecia/inducido químicamente , Alopecia/tratamiento farmacológicoRESUMEN
OBJECTIVE: To reveal the clinical features and assess risk factors linked to brain fog and its societal implications, including labor productivity, providing valuable insights for the future care of individuals who have experienced coronavirus disease 2019 (COVID-19). METHODS: We analyzed a comprehensive cohort dataset comprising 1,009 patients with COVID-19 admitted to Japanese hospitals. To assess brain fog, we analyzed patients who responded to a questionnaire indicating symptoms such as memory impairment and poor concentration. RESULTS: The prevalence of brain fog symptoms decreased 3 months posthospitalization but remained stable up to 12 months. Neurological symptoms such as taste and smell disorders and numbness at hospitalization correlated with a higher frequency of identifying brain fog as a long COVID manifestation. Our findings indicated that advanced age, female sex, a high body mass index, oxygen required during hospitalization, chronic obstructive pulmonary disease, asthma, and elevated C-reactive protein and elevated D-dimer levels were risk factors in patients exhibiting brain fog. Additionally, we demonstrated the negative impact of brain fog on labor productivity by presenteeism scores. INTERPRETATIONS: This study clarified the clinical characteristics of patients experiencing brain fog as a long COVID manifestation, specifically emphasizing neurological symptoms during hospitalization and their correlation with brain fog. Additionally, the study identified associated risk factors for its onset and revealed that the emergence of brain fog was linked to a decline in labor productivity.
Asunto(s)
COVID-19 , Humanos , COVID-19/epidemiología , Femenino , Masculino , Factores de Riesgo , Persona de Mediana Edad , Japón/epidemiología , Anciano , Adulto , Síndrome Post Agudo de COVID-19 , Estudios de Cohortes , Hospitalización/estadística & datos numéricos , Trastornos de la Memoria/epidemiología , Trastornos de la Memoria/etiología , Anciano de 80 o más Años , SARS-CoV-2 , Pueblos del Este de AsiaRESUMEN
A homogeneous structural distribution in metal nanoparticle is commonly required for their application, and despite high-yield growth techniques, unavoidable structural heterogeneity remains a concern in metal nanoparticle synthesis. Gold nanotriangles (AuNTs) were synthesized using seed-mediated and seedless growth methods. Recent advancements in high-yield synthesis processes have enabled easy handling of AuNTs, which exhibit unique localized surface plasmon resonance characteristics due to their anisotropic triangular form. The flocculation and subsequent precipitation technique was used to purify AuNTs of different sizes synthesized using seed-mediated and seedless growth methods. The optimal conditions for obtaining high-purity AuNTs were explored by introducing a high concentration of cetyltrimethylammonium chloride. Additionally, the depletion force necessary for achieving high-purity AuNTs was calculated to reveal variations in the required depletion forces for AuNTs synthesized using different growth techniques. The alternations in the size distribution of AuNTs during the flocculation step were tracked using dynamic light scattering, and the surface charge of AuNTs synthesized through different growth methods was evaluated by ζ-potential. The high purity of the AuNTs produced using the seedless growth method required a larger depletion force than the seed-mediated grown AuNTs. The difference in the required depletion forces results from the difference in the electrostatic forces caused by the different growth methods.
RESUMEN
Driving assistance systems that support drivers by adapting to driver characteristics can provide appropriate feedback and prevent traffic accidents. Cognitive function is helpful information for such systems to assist older drivers, and automatic estimation of drivers' cognitive function enables systems to utilize this information without being burdensome to these drivers. Therefore, this study aims to estimate drivers' cognitive function from daily driving data. We focus on modeling the scores of Trail Making Test (A) and (B) as measures of cognitive function, which indicate general cognitive ability. The main challenge is learning the generalized mapping function to the cognitive status from driving behavioral features extracted from the different driving routes of each driver. To address this problem, the proposed method focuses on particular driving scenarios in which differences in cognitive function can be observed. We evaluate the performance of the proposed model and the effectiveness of driving scenario information. Experimental results show that the results of Trail Making Tests (A) and (B) can be estimated with Spearman rank correlation coefficients of r = 0.34 and 0.48, respectively. In addition, the proposed method makes it easier to analyze the relationships between driving behaviors and cognitive function by comparing driving behaviors (e.g., steering angle velocity) in specific driving scenarios (e.g., intersections).
Asunto(s)
Conducción de Automóvil , Conducción de Automóvil/psicología , Accidentes de Tránsito/prevención & control , Cognición , AprendizajeRESUMEN
BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly since 2019, and the number of reports regarding long COVID has increased. Although the distribution of long COVID depends on patient characteristics, epidemiological data on Japanese patients are limited. Hence, this study aimed to investigate the distribution of long COVID in Japanese patients. This study is the first nationwide Japanese prospective cohort study on long COVID. METHODS: This multicenter, prospective cohort study enrolled hospitalized COVID-19 patients aged ≥18 years at 26 Japanese medical institutions. In total, 1200 patients were enrolled. Clinical information and patient-reported outcomes were collected from medical records, paper questionnaires, and smartphone applications. RESULTS: We collected data from 1066 cases with both medical records and patient-reported outcomes. The proportion of patients with at least one symptom decreased chronologically from 93.9% (947/1009) during hospitalization to 46.3% (433/935), 40.5% (350/865), and 33.0% (239/724) at 3, 6, and 12 months, respectively. Patients with at least one long COVID symptom showed lower quality of life and scored higher on assessments for depression, anxiety, and fear of COVID-19. Female sex, middle age (41-64 years), oxygen requirement, and critical condition during hospitalization were risk factors for long COVID. CONCLUSIONS: This study elucidated the symptom distribution and risks of long COVID in the Japanese population. This study provides reference data for future studies of long COVID in Japan.
Asunto(s)
COVID-19 , Síndrome Post Agudo de COVID-19 , Adulto , Femenino , Humanos , Persona de Mediana Edad , COVID-19/epidemiología , Pueblos del Este de Asia , Síndrome Post Agudo de COVID-19/epidemiología , Estudios Prospectivos , Calidad de Vida , SARS-CoV-2RESUMEN
PURPOSE: Clear evidence indicating whether surgery or stereotactic body radiation therapy (SBRT) is best for non-small-cell lung cancer (NSCLC) is lacking. SBRT has many advantages. We used artificial neural networks (NNs) to predict treatment outcomes for patients with NSCLC receiving SBRT, aiming to aid in decision making. PATIENTS AND METHODS: Among consecutive patients receiving SBRT between 2005 and 2019 in our institution, we retrospectively identified those with Tis-T4N0M0 NSCLC. We constructed two NNs for prediction of overall survival (OS) and cancer progression in the first 5 years after SBRT, which were tested using an internal and an external test data set. We performed risk group stratification, wherein 5-year OS and cancer progression were stratified into three groups. RESULTS: In total, 692 patients in our institution and 100 patients randomly chosen in the external institution were enrolled. The NNs resulted in concordance indexes for OS of 0.76 (95% CI, 0.73 to 0.79), 0.68 (95% CI, 0.60 to 0.75), and 0.69 (95% CI, 0.61 to 0.76) and area under the curve for cancer progression of 0.80 (95% CI, 0.75 to 0.84), 0.72 (95% CI, 0.60 to 0.83), and 0.70 (95% CI, 0.57 to 0.81) in the training, internal test, and external test data sets, respectively. The survival and cumulative incidence curves were significantly stratified. NNs selected low-risk cancer progression groups of 5.6%, 6.9%, and 7.0% in the training, internal test, and external test data sets, respectively, suggesting that 48% of patients with peripheral Tis-4N0M0 NSCLC can be at low-risk for cancer progression. CONCLUSION: Predictions of SBRT outcomes using NNs were useful for Tis-4N0M0 NSCLC. Our results are anticipated to open new avenues for NN predictions and provide decision-making guidance for patients and physicians.
Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Radiocirugia , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/radioterapia , Estadificación de Neoplasias , Redes Neurales de la Computación , Radiocirugia/métodos , Estudios RetrospectivosRESUMEN
Digital subtraction angiography (DSA) is a powerful technique for visualizing blood vessels from X-ray images. However, the subtraction images obtained with this technique suffer from artifacts caused by patient motion. To avoid these artifacts, a new method called "Virtual DSA" is proposed, which generates DSA images directly from a single live image without using a mask image. The proposed Virtual DSA method was developed using the U-Net deep learning architecture. In the proposed method, a virtual DSA image only containing the extracted blood vessels was generated by inputting a single live image into U-Net. To extract the blood vessels more accurately, U-Net operates on each small area via a patch-based process. In addition, a different network was used for each zone to use the local information. The evaluation of the live images of the head confirmed accurate blood vessel extraction without artifacts in the virtual DSA image generated with the proposed method. In this study, the NMSE, PSNR, and SSIM indices were 8.58%, 33.86 dB, and 0.829, respectively. These results indicate that the proposed method can visualize blood vessels without motion artifacts from a single live image.
Asunto(s)
Artefactos , Angiografía de Substracción Digital , Humanos , Movimiento (Física)RESUMEN
OBJECTIVE: The process of dental root resorption and subsequent cementum regeneration has not been sufficiently elucidated. This study aimed to examine the process of the root resorption and cementum regeneration during physiological tooth drift using a rat model, and to evaluate this experimental model. METHODS: Distal roots in mandibular first molars and the surrounding periodontal tissues were investigated with light and electron microscopy. The light microscopic approach included histochemical and histometric analyses utilizing the tartrate-resistant acid phosphatase (TRAP) reaction. RESULTS: Root resorption was observed in the distal side of the roots and was most active in 5- to 6-week-old rats, and gradually decreased hereafter. An increase in the number of TRAP-positive mononuclear cells, which seemed to be odontoclast precursor cells, preceded the increase in the number of odontoclasts. Root resorption was transient, and was followed by the new formation of acellular extrinsic fiber cementum accompanied with only a slight inflammation, and therefore classified as external surface resorption. Preparation for new cementum started adjacent to the resorption areas when root resorption was most active. CONCLUSIONS: The root resorption during drift in rats is transient and followed by acellular extrinsic fiber cementum regeneration. Cellular kinetics suggested that odontoclast precursor cells are supplied as mononuclear cells from vascular spaces.