Interaction of treatment with a continuous variable: simulation study of power for several methods of analysis

In a large simulation study reported in a companion paper, we investigated the significance levels of 21 methods for investigating interactions between binary treatment and a continuous covariate in a randomised controlled trial. Several of the methods were shown to have inflated type 1 errors. In the present paper, we report the second part of the simulation study in which we investigated the power of the interaction procedures for two sample sizes and with two distributions of the covariate (well and badly behaved). We studied several methods involving categorisation and others in which the covariate was kept continuous, including fractional polynomials and splines. We believe that the results provide sufficient evidence to recommend the multivariable fractional polynomial interaction procedure as a suitable approach to investigate interactions of treatment with a continuous variable. If subject‐matter knowledge gives good arguments for a non‐monotone treatment effect function, we propose to use a second‐degree fractional polynomial approach, but otherwise a first‐degree fractional polynomial (FP1) function with added flexibility (FLEX3) is the method of choice. The FP1 class includes the linear function, and the selected functions are simple, understandable, and transferable. Furthermore, software is available. We caution that investigation of interactions in one dataset can only be interpreted in a hypothesis‐generating sense and needs validation in new data. Copyright © 2014 John Wiley & Sons, Ltd.     

A prospective,multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients’ trial

Relapsed or refractory acute myeloid leukemia (R/R AML) in elderly (≥60 yr old) patients were eligible. Induction chemotherapy consisted fludarabine and cytarabine (ARAC) as a 24‐hr CI without idarubicin (C‐FLAG), which was compared with the results of C‐FLAG with idarubicin (CI‐FLAG2) in younger patients’ trial. A total of 33 and 68 patients were enrolled in C‐FLAG and CI‐FLAG2, respectively. CR, CRp, and CRi were achieved in 10 (30.3%), 3 (9.1%), and 2 (6.1%), respectively. When comparing outcomes between C‐FLAG and CI‐FLAG2, there were no difference in terms of CR rate (P = 0.572) and objective response rate (ORR; P = 0.899). Favorable predictors on ORR in C‐FLAG were PB WBC ≤ 20K/uL at salvage (P = 0.024) and early evaluation peripheral BLAST = 0% (P = 0.013) on multivariate analysis. The overall survival of patients who achieve CR/CRp/CRi showed significantly prolonged survival compared with patients who did not in C‐FLAG (P < 0.001) and was a favorable predictor of longer survival by multivariate analysis (P = 0.009). Median overall survival was 3.19 (95% CI, 2.05–4.33) months and similar with that of CI‐FLAG2 (P = 0.841). Attenuated salvage regimen C‐FLGA in elderly patients was as effective as more intensive younger patients’ regimen CI‐FLAG2 in terms of response and survival although elderly patients had more unfavorable clinical characteristics.     

The perception of the Illness with Subsequent Outcome Measure in More Favorable in Continuos Peritoneal Dialysis vs Hemodialysis in the Framework of Appraisal Model of Stress

The aim of the study was to use the appraisal model of stress to compare hemodialysis (HD) and continuous peritoneal dialysis (CAPD) patients with special focus on the perception of end-stage renal disease and subsequent emotional profile and health related quality of life (HQoL) in. We hypothesize that different circumstances related to both modes of therapies will result in dissimilar perception of chronic illness with subsequent changes in emotional profile and heath related quality of life. The total of 88 patients with end stage renal disease (ESRD) enrolled in hemodialysis (n=52; HD) or continuous peritoneal dialysis (n=36; CAPD) were given a battery of psychological tests: The Profile of Mood States, The Nottingham Health Profile, The Stress Situation Assessment Questionnaire, The Social Appreciation Questionnaire and The Situation and Trait and Anxiety Inventory. All patients perceived ESRD in terms of a loss and a threat. Moreover, CAPD patients evaluated ESRD as a challenge. Despite different perception of ESRD no significant difference in the level of fear, anxiety or emotional profile was found. Both HD and CAPD patient were reported more fatigue/inertia and confusion/bewilderment than control groups. The main health related complaints were similar in both ESRD patients with major complaints of sleeping disturbances, motor limitations and lack of energy. From the psychological point of view, CAPD treatment seems more like challenge to the enrolled patient which is positive outcome. Despite different appraisal of stress mood and health related complaints were similar in both groups. This may be a result of optimal regulation of cognitive perception of the stress depending on the circumstances of therapy.     

高强度间歇训练与中等强度持续训练对冠心病患者心肺功能影响的Meta分析

背景　冠心病（CHD）是心血管疾病的头号杀手，患病率和发病率一直居高不下，运动作为CHD患者的重要干预手段，一直受到广泛关注。高强度间歇训练（HIIT）与中等强度持续训练（MICT）对于改善CHD患者的心肺功能均显示出有效性，但研究结果尚存争议。因此，选择更合理的运动干预手段，对CHD患者的康复至关重要。目的　探讨HIIT与MICT对CHD患者心肺功能的影响，为CHD患者运动处方的制订提供合理依据。方法　计算机检索PubMed、EMBase、The Cochrane Library、Web of Science、中国生物医学文献数据库（CBM）、中国知网（CNKI）、维普网和万方数据知识服务平台，搜集应用HIIT与MICT干预CHD患者心肺功能的文献，检索时限均为建库至2020年11月。收集第一作者、发表时间、国家、总样本、性别、年龄、运动类型、运动周期、运动频率、运动处方（HIIT、MICT）、结局指标〔峰值摄氧量（VO2peak），无氧阈（VO2AT），最大心率（HRmax），血压（BP），呼吸交换比率（RER），CO2通气当量斜率（VE/VCO2 Slope），静息心率（HRrest）〕等信息，采用Cochrane偏倚风险评估工具对纳入的研究进行方法学质量评估，采用Review Manage 5.3和Stata 15.1软件进行统计学分析。结果　共纳入了12篇文献，其中存在低、中、高风险的研究分别为3篇、8篇和1篇。纳入研究总样本量为618例，其中接受HIIT、MICT干预的样本量分别为305例和313例。Meta分析结果显示：HIIT对VO2peak〔MD=1.63，95%CI（0.64，2.62），P=0.001〕、VO2AT〔MD=2.62，95%CI（0.82，4.42），P=0.004〕、HRmax〔MD=5.41，95%CI（2.28，8.53），P=0.000 7〕、SBP〔MD=3.16，95%CI（0.26，6.06），P=0.03〕的改善效果均优于MICT。两种运动模式对RER〔MD=0.01，95%CI（-0.01，0.03），P=0.27〕、VE/VCO2 Slope〔MD=-0.26，95%CI（-1.87，1.34），P=0.75〕、HRrest〔MD=1.19，95%CI（-0.42，2.80），P=0.15〕、DBP〔MD=2.56，95%CI（-0.21，5.32），P=0.07〕的改善效果比较，差异无统计学意义。亚组分析结果显示，对于干预周期在12周及以上的患者，HIIT对于VO2peak、RER、VO2AT和HRmax的改善效果优于MICT（P<0.05）；而干预周期在12周以下的患者，两种运动模式对于各指标的改善效果比较，差异无统计学意义（P>0.05）。结论　HIIT在改善患者VO2peak、VO2AT、HRmax以及BP方面均优于MICT，且干预周期12周及以上的CHD患者HIIT较MICT改善心肺功能的优势更明显。     

持续质量改进措施在医院卫生管理中的应用

目的分析在新时期医院卫生管理工作中实施持续质量改进措施的效果。方法选取2017年1月—2018年1月期间本院60名医务人员作为对照组,给予常规卫生管理,选取2018年2月—2019年2月期间本院60名医务人员作为观察组,给予持续质量改进管理,对比两组管理效果。结果组间对比,观察组手卫生执行率、手卫生合格率、无菌操作规范率均高于对照组,且观察组卫生知识考核评分及护理满意度评分也高于对照组(P<0.05)。结论在新时期医院卫生管理中实施持续质量改进措施,更有利于提高医院卫生管理的整体水平,进而为医院的安全、健康、稳定运行提供保障。     

军队医院等级评审中医学装备管理部门的作用探讨

分析了医学装备管理现状以及等级评审对设备管理部门的作用要求,指出了如何发挥医院装备管理的作用,从院部领导高度重视、迎评工作组织严密、强化标准学习、修订各项规章制度等方面重点阐述了等级医院评审中的实践经验与体会,以期为医学装备管理部门提供参考.