Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

Introduction: In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis is suspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCC remains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC. Methods and analysis: This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoint are 3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias. Ethics and dissemination: This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the corresponding author on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals

Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

Introduction In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis issuspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCCremains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC.Methods and analysis This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoints are3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias.Ethics and dissemination This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the correspondingauthor on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals

Prevalence of type 2 diabetes by age, sex and geographical area among two million public assistance recipients in Japan: a cross-sectional study using a nationally representative claims database

生活保護受給者の糖尿病有病実態解明 --200万人のレセプトデータ解析--. 京都大学プレスリリース. 2021-11-16.[Background] Recognising the importance of the social determinants of health, the Japanese government introduced a health management support programme targeted at type 2 diabetes (T2D) for public assistance recipients (PAR) in 2018. However, evidence of the T2D prevalence among PAR is lacking. We aimed to estimate T2D prevalence by age and sex among PAR, compared with the prevalence among health insurance enrollees (HIE). Additionally, regional differences in T2D prevalence among PAR were examined. [Methods] This was a cross-sectional study using 1-month health insurance claims of both PAR and HIE. The Fact-finding Survey data on Medical Assistance and the National Database of Health Insurance Claims data were used. T2D prevalence among PAR and HIE were assessed by age and sex, respectively. Moreover, to examine regional differences in T2D prevalence of inpatients and outpatients among PAR, T2D crude prevalence and age-standardised prevalence were calculated by prefecture. Multilevel logistic regression analysis was also conducted at the city level. [Results] T2D crude prevalence was 7.7% in PAR (inpatients and outpatients). Among outpatients, the prevalence was 7.5% in PAR and 4.1% in HIE, respectively. The mean crude prevalence and age-standardised prevalence of T2D (inpatients and outpatients) among 47 prefectures were 7.8% and 3.9%, respectively. In the city-level analysis, the OR for the prevalence of T2D by region ranged from 0.31 to 1.51. [Conclusion] The prevalence of T2D among PAR was higher than HIE and there were regional differences in the prevalence of PAR. Measures to prevent the progression of diabetes among PAR by region are needed