On estimands arising from misspecified semiparametric rate-based analysis of recurrent episodic conditions

Marginal rate-based analyses are widely used for the analysis of recurrent events in clinical trials. In many areas of application, the events are not instantaneous but rather signal the onset of a symptomatic episode representing a recurrent infection, respiratory exacerbation, or bout of acute depression. In rate-based analyses, it is unclear how to best handle the time during which individuals are experiencing symptoms and hence are not at risk. We derive the limiting value of the Nelson-Aalen estimator and estimators of the regression coefficients under a semiparametric rate-based model in terms of an underlying two-state process. We investigate the impact of the distribution of the episode durations, heterogeneity, and dependence on the asymptotic and finite sample properties of standard estimators. We also consider the impact of these features on power in trials designed to test intervention effects on rate functions. An application to a trial of individuals with herpes simplex virus is given for illustration.     

Self-assessed preoperative level of habitual physical activity predicted postoperative complications after colorectal cancer surgery: A prospective observational cohort study

IntroductionThere is a growing interest in physical activity in relation to recovery after surgery. One important aspect of measuring recovery after surgical procedures is postoperative complications. The aim of this study was to determine if there is an association between the preoperative level of habitual physical activity and postoperative complications in patients undergoing elective surgery for colorectal cancer.Materials and methods115 patients scheduled for elective surgery due to colorectal cancer between February 2014 and September 2015 answered a questionnaire regarding physical activity and other baseline variables. Physical activity was assessed using the Saltin-Grimby physical activity level scale. Complications within 30 days after surgery were classified according to Clavien-Dindo, and the Comprehensive Complications Index (CCI) was calculated. Primary outcome was difference in CCI and key secondary outcome was risk for CCI ≥20.ResultsPhysically inactive individuals had a CCI that was 12 points higher than individuals with light activity (p = 0.002) and 17 points higher than regularly active individuals (p = 0.0004). Inactive individuals had a relative risk for a CCI ≥20 that was 65% higher than for individuals reporting light activity (95% confidence interval (CI) for relative risk (RR) = 1.1–2.5) and 338% higher than for regularly active individuals (95% CI for RR = 2.1–9.4).ConclusionSelf-assessed level of habitual physical activity before colorectal cancer surgery was associated with fewer postoperative complications measured with CCI, in a dose-response relationship.     

加速康复外科在日间病房内镜逆行胰胆管造影治疗胆总管结石中的应用

目的探讨加速康复外科（ERAS）在日间病房内镜逆行胰胆管造影（ERCP）治疗胆总管结石（CBDS）中的安全性、有效性。 方法回顾性分析2015年4月至2018年4月新疆医科大学第一附属医院肝胆包虫科接受ERCP术治疗的CBDS患者211例。其中在2015年4月至2016年3月间接受传统治疗的患者85例，设为传统治疗组；2016年4月至2018年4月间接受ERAS日间治疗的126例，设为ERAS日间组。分析比较两组患者围手术期及随访情况。 结果ERAS日间组患者的首次进食时间、下床活动时间显著早于传统治疗组（P<0.05），平均术后住院时间、医疗费用、口渴/饥饿感、术后恶心呕吐（PONV）发生率、腹胀腹痛发生率及术后3、12 h血清淀粉酶水平明显低于传统治疗组（P<0.05）；ERAS日间组患者满意度评分为（96.66±3.39）分，显著高于传统治疗组的（90.25±4.87）分（t=10.54，P<0.05），术后疼痛评分显著低于传统治疗组（z=-5.12，P<0.05）。两组患者无一例30 d内再入院，术后并发症发生率、白细胞计数比较，差异无统计学意义。 结论在ERAS模式下行日间ERCP治疗CBDS是安全可行的，可加快患者康复，减轻术后疼痛，提高患者满意度。     

加速康复外科在肾移植术后静脉补液中的应用

目的探讨加速康复外科(ERAS)在肾移植术后静脉补液中的应用。 方法回顾性分析陆军军医大学第一附属医院124例肾移植受者临床资料。根据肾移植术后多尿期每24小时静脉补液量分为3组，A组每24小时静脉补液量2 500～<4 000 mL，术后6 h进食流质；B组每24小时补液量4 000～6 000 mL，肛门排气后进食；C组每24小时补液量>6 000 mL，肛门排气后进食。采用单因素方差分析比较3组受者术后1周中心静脉压(CVP)、心率、血压、尿量和血糖以及平均特护时间、平均住院日和术后1个月血清肌酐。采用χ²检验比较3组受者性别、供肾类型以及术后高血糖、伤口延迟愈合和移植肾功能延迟恢复(DGF)发生率。P<0.05为差异有统计学意义。 结果A、B和C组受者术后1个月血清肌酐分别为(110±23)、(114±22)和(118±22)μmol/L，差异无统计学意义(F＝1.19，P>0.05)。A组受者术后1周CVP、收缩压、尿量和血糖均低于B、C组(P均<0.05)，平均特护时间和平均住院日均短于B、C组(P均<0.05)。3组受者术后高血糖和DGF发生率差异均无统计学意义(χ²＝4.581和0.404，P均>0.05)，A组受者伤口愈合延迟发生率低于C组(χ²＝7.303，P<0.017)。仅C组1例受者因心力衰竭和肺水肿死亡。 结论ERAS适用于肾移植受者术后静脉补液策略，鼓励受者尽早饮水进食，在保证血压正常或偏高的情况下，适当减少静脉补液量，有利于减少并发症，促进受者恢复。     

基于零缺陷管理理论构建肝胆外科加速康复评价指标体系

目的构建适用于肝胆外科的加速康复评价指标体系,为加速康复外科实施效果提供评价工具。方法在零缺陷管理理论基础上,通过文献查阅、德尔菲专家咨询法构建肝胆外科加速康复评价指标体系。结果 2轮问卷回收率均为100%,专家权威系数分别为0.920、0.919。经过2轮专家咨询,最终构建的肝胆外科加速康复评价指标体系包括3个一级指标,8个二级指标,39个三级指标;指标重要性评分均4分,变异系数0～0.166;并确定各级指标权重。结论肝胆外科加速康复评价指标体系构建合理,有较好的可信度,经验证后可作为肝胆外科加速康复质量评价工具。     

Prevalence and pathophysiology of early dumping in patients after primary Roux-en-Y gastric bypass during a mixed-meal tolerance test

Background

Early dumping is a poorly defined and incompletely understood complication after Roux-en-Y gastric (RYGB).