Intention-to-Treat Analyses for Randomized Controlled Trials in Hospice/Palliative Care: The Case for Analyses to be of People Exposed to the Intervention

ContextMinimizing bias in randomized controlled trials (RCTs) includes intention-to-treat analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomization and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered nonresponders.ObjectivesThis study aimed to quantify the impact within intention-to-treat principles.MethodsA theoretical model was developed to assess the impact of withdrawals between randomization and first exposure on study power and effect sizes. Ten reported hospice/palliative care studies had power recalculated accounting for such withdrawal.ResultsIn the theoretical model, when 5% of withdrawals occurred between randomization and first exposure to the intervention, change in power was demonstrated in binary outcomes (2.0%–2.2%), continuous outcomes (0.8%–2.0%), and time-to-event outcomes (1.6%–2.0%), and odds ratios were changed by 0.06–0.17. Greater power loss was observed with larger effect sizes. Withdrawal rates were 0.9%–10% in the 10 reported RCTs, corresponding to power losses of 0.1%–2.2%. For studies with binary outcomes, withdrawal rates were 0.3%–1.2% changing odds ratios by 0.01–0.22.ConclusionIf blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomization and first exposure to the intervention minimizes one bias. This is the safety population as defined by the International Committee on Harmonization. When planning for future trials, minimizing the time between randomization and first exposure to the intervention will minimize the problem. Power should be calculated on people who receive the intervention.     

医院信息化系统在武汉新冠肺炎防疫救治过程中暴露出的问题及其引发的思考

目的针对武汉地区医院信息化系统在新型冠状病毒肺炎(简称新冠肺炎)防疫救治过程中暴露出的问题,提出应对突发公共卫生事件时医院信息化的完善方法。方法充分分析医院信息化系统在新冠肺炎防疫救治中所暴露出的各个医院信息化系统结构不同、各个医院之间无法实施信息共享、门诊病房之间系统相互独立、数据信息更新不及时等九大问题,并提出医院信息化基础布局的建立、区域链及大数据临床中的应用等多项措施。结果医院信息化能力的提高有助于降低医护人员工作强度,提高患者的安全。结论新冠肺炎疫情的发生给我国医院信息化系统带来了严峻的挑战,但同时也给我们带来了更大的机遇。我国在未来针对突发公共卫生事件时,医院信息化将为医护人员、患者提供更有利的支持。     

Developing cross-sectoral quality assurance for cataract surgery in the statutory quality assurance program of the German health care system: Experiences and lessons learned

Since 2001, statutory external quality assurance (QA) for hospital care has been in place in the German health system. In 2009, the decision was taken to expand it to cross-sectoral procedures. This novel and unprecedented form of national QA aims at (1) making the quality procedures comparable that are provided both in inpatient and outpatient care, (2) following-up outcomes of hospital care after patients’ discharge and (3) measuring the quality of complex treatment chains across interfaces. As a pioneer procedure a QA procedure in cataract surgery QA was developed. Using this as an example, challenges of cross-sectoral QA are highlighted. These challenges relate, in particular, to three technical problems: triggering cases for documentation, following-up patients’ after hospital discharge, and the burden of documentation in outpatient care. These problems resulted finally in the haltering of the development of the QA procedure. However, the experiences gained with this first development of cross-sectoral QA inspired the reorientation and further development of the field in Germany. Future cross-sectoral QA will rigorously aim at keeping burden of documentation small. It will draw data for QA mainly at three sources: routine data, patient surveys and peer reviews using indicators. Policy implications of this reorientation are discussed.     

益气养阴法对晚期肺腺癌患者化疗毒副反应影响的临床研究

目的本文观察益气养阴法对气阴两虚型晚期肺腺癌患者化疗毒副反应的影响。方法运用随机对照法,40例患者分为两组,治疗组采用益气养阴中药联合AP方案,对照组单用AP方案,观察两组临床症状、KPS评分及毒副反应的改善情况。结果治疗组中医临床症状、KPS评分、化疗相关消化道反应与对照组相比有显著差异(P0.05),在血液学毒性方面两组无显著差异(P0.05)。结论益气养阴法联合化疗可显著改善患者的临床症状与体力状况,减轻化疗相关消化道反应,提高患者化疗耐受性,且中西医联合治疗并不增加血液学毒性,具有较好的安全性。     

Determinants of Regional Variation in Health Expenditures in Germany

Health care expenditure in Germany shows clear regional differences. Such geographic variations are often seen as an indicator for inefficiency. With its homogeneous health care system, low co‐payments and uniform prices, Germany is a particularly suited example to analyse regional variations. We use data for the year 2011 on expenditure, utilization of health services and state of health in Germany's statutory health insurance system. This data, which originate from a variety of administrative sources and cover about 90% of the population, are enriched with a wealth of socio‐economic variables, data on pollutants, prices and individual preferences. State of health and demography explains 55% of the differences as measured by the standard deviation while all control variables account for a total of 72% of the differences at county level. With other measures of variation, we can account for an even greater proportion. A higher proportion of variation than usually supposed can thus be explained. Whilst this study cannot quantify inefficiencies, our results contradict the thesis that regional variations reflect inefficiency. Copyright © 2015 John Wiley & Sons, Ltd.     

腹膜透析患者并发胸腹瘘5例分析

目的探讨腹膜透析患者并发胸腹瘘的临床表现、诊断方法及治疗与转归。方法对2011年1月—2014年12月收治的腹膜透析并发胸腹瘘患者5例的临床表现、诊断方法及治疗与转归进行分析。结果 5例患者均出现胸闷、气促;影像学检查提示中~大量右侧胸腔积液;胸水透明清亮,蛋白定性试验阴性,胸水蛋白定量<25g/L,葡萄糖>40 mmol/L,美蓝试验阳性,DPTA试验阳性。确诊后经抽取胸水、暂停持续非卧床腹膜透析,其中4例患者最终转为血液透析治疗,1例改为间歇性腹膜透析,瘘口愈合后再行维持性腹膜透析。结论胸腹瘘有胸腔负压消失的临床特点,用美蓝试验及核素扫描结合胸水生化成分分析诊断胸腹瘘敏感性高,不良反应少。出现胸腹瘘后患者大多转为维持性血液透析,较难再维持腹膜透析治疗。     

The use of big data in transfusion medicine

‘Big data’ refers to the huge quantities of digital information now available that describe much of human activity. The science of data management and analysis is rapidly developing to enable organisations to convert data into useful information and knowledge. Electronic health records and new developments in Pathology Informatics now support the collection of ‘big laboratory and clinical data’, and these digital innovations are now being applied to transfusion medicine. To use big data effectively, we must address concerns about confidentiality and the need for a change in culture and practice, remove barriers to adopting common operating systems and data standards and ensure the safe and secure storage of sensitive personal information. In the UK, the aim is to formulate a single set of data and standards for communicating test results and so enable pathology data to contribute to national datasets. In transfusion, big data has been used for benchmarking, detection of transfusion‐related complications, determining patterns of blood use and definition of blood order schedules for surgery. More generally, rapidly available information can monitor compliance with key performance indicators for patient blood management and inventory management leading to better patient care and reduced use of blood. The challenges of enabling reliable systems and analysis of big data and securing funding in the restrictive financial climate are formidable, but not insurmountable. The promise is that digital information will soon improve the implementation of best practice in transfusion medicine and patient blood management globally.