不同类型临床证据在卫生决策中的应用进展：以英国NICE为例

传统的随机对照试验与真实世界研究在内部有效性和外部可推广性方面各占优势,随着循证卫生决策的发展,随机对照试验不再是干预性临床证据的唯一金标准,真实世界研究证据正逐渐参与到卫生决策中来。本文通过梳理英国NICE在卫生项目有效性评估过程中对证据的要求和证据实际应用现状,发现目前NICE仍将随机对照试验结果作为主要依据,真实世界研究虽近年来发展火热,但由于本身设计存在潜在偏倚且受限于很多因素,在卫生决策中仍使用较少。但近年来,在创新药或者缺乏治疗药物的疾病领域,真实世界证据则发挥了较大作用。随着真实世界研究在试验设计和数据分析等方面的逐步完善,相信其将在卫生决策中发挥更重要的作用。     

ICU患儿压力性损伤预防及护理的证据总结

目的 ：评价并整合国内外ICU患儿压力性损伤预防及护理的证据。方法 ：计算机检索临床决策及指南网站、专业协会网站、循证文献资源及各大文献数据库中关于ICU患儿压力性损伤预防及护理的指南、证据总结、系统评价、随机对照试验及专家共识等。采用JBI循证中心的文献评价标准和证据分级系统,评价不同类型研究的文献质量并评定其证据级别。结果 ：本研究共纳入11篇文献,其中1篇指南、5篇证据总结、2篇系统评价、3篇随机对照试验。获取33条证据并归纳为风险评估、器械相关、体位管理、治疗护理、手术预防5个方面。结论 ：医护人员应结合实际医疗环境和患儿情况,选择最佳证据实施预防及护理,降低压力性损伤发生率,以提高ICU患儿压力性损伤管理的规范性和有效性。     

真实世界证据

真实世界证据是在现实医疗环境中,通过优化分析来源于多种途径的数据而获得的证据。其与传统临床研究证据的本质区别在于获取数据的环境,而非研究方法或试验设计。与传统随机对照临床试验证据相比,真实世界证据具有结果外推性好、研究效率高等优势,可广泛应用于医疗产品有效性和安全性评价、临床实践过程分析等领域。近年来,随着信息技术的飞速发展和医学循证需求的持续增加,真实世界研究愈发受到人们重视,发展前景良好。     

随机对照试验中常见误区辨识与应对

随机对照试验是评估不同干预措施疗效和常见不良反应的标准设计方案，但我国随机对照试验在研究设计、实施、效应指标选择、数据分析和结果解释等方面仍有提升空间。本文从随机对照试验实施的关键技术、结果展示和结果解读3方面分析了6点常见误区，期望帮助临床研究者明确随机化概念，正确实施随机分配方法和分配方案隐藏、正确理解随机对照试验中的基线平衡问题、合理选择效应指标、正确解读研究结果的统计学意义和临床意义，以生产更多高质量的随机对照试验证据，同时避免被误导。     

不同侧卧位角度对压力性损伤预防效果的系统评价

目的 评价不同侧卧位角度对卧床患者压力性损伤发生率的影响.方法 计算机检索PubMed、Cochrane Library、CINAHL、Web of Science、EMbase、CNKI、SinoMed、万方数据库、维普数据库中不同侧卧位角度对卧床患者压力性损伤发生率影响的临床随机对照试验,经过文献筛选、质量评价、资料提取后,采用RevMan5.3对资料进行Meta分析.结果 研究共纳入6篇随机对照试验,这些试验结果显示30°侧卧位较90°侧卧位更能有效预防压力性损伤的发生.不同侧卧位角度对压力性损伤预防效果的临床随机对照试验少,研究方法较局限,但近期有较多研究通过招募志愿者,比较其多个侧卧位角度时的皮肤表面压力、血流量、温度等,以探索卧床患者最佳侧卧位角度.结论 现有的证据表明,30°侧卧位与90°侧卧位相比,可能会减少压力性损伤的发生,但仍需高质量、大规模、多中心的研究支持,且需要更多设计严谨的研究进一步探索卧床患者的最佳侧卧位角度.     

国内化疗性静脉炎预防护理的临床证据及评价

目的调查国内预防化疗性静脉炎的护理研究现状,并评价证据强度及存在问题。方法应用计算机检索2005年1月～2011年6月国内5本护理核心期刊中关于预防化疗性静脉炎的随机对照研究文献,严格质量评价后进行分析。了解国内预防化疗性静脉炎的护理研究现状,并评价证据强度及存在问题。结果最终纳入24篇研究,17篇探讨药物外敷或外涂(其中单一药物外敷或外涂8篇、联合药物外敷9篇)、2篇探讨药物冲管(内用药物)的预防护理、2篇为药物冲管加外敷(外用和内用药物)的联合防治、3篇探讨非药物应用(特殊透明贴及精细过滤器的应用);国内预防化疗性静脉炎的文献证据强度不足;判定标准不统一,且结局指标单一。结论今后应该开展设计更加严谨的大样本、高质量的随机对照研究,而且应注重开展非药物方法预防化疗性静脉炎、复合指标判断化疗性静脉炎疗效的研究。     

真实世界研究中Zelen设计应用探讨

随着真实世界研究体系的逐渐规范和完善,真实世界证据作为传统随机对照试验证据的补充,在药械产品有效性和安全性评价等方面逐渐被广泛应用。而高质量的真实世界证据不仅与真实世界数据质量有关,而且取决于研究设计类型,因此作为实用临床试验的重要设计方式之一,Zelen设计近年来备受研究者关注。本文将基于既往研究报道探讨其实施流程、设计类型、优势及局限性、统计学考量和合理应用场景,厘清其在真实世界研究领域的应用价值,为后续研究提供借鉴。     

循证护理实践推荐

正临床问题医用蜂蜜用于促进伤口愈合和减少伤口异味的证据有哪些?证据来源本证据总结基于系统检索循证卫生保健数据库。证据来源于:1篇综述文献,4篇随机对照试验,2篇观察性研究,12篇临床病例总结及病例报告。     

中国临床医学界应该产出更多高质量随机对照试验

临床随机对照试验研究的重要意义 临床随机对照试验研究由于控制系统偏倚最好,既是获得临床科学证据的最重要的研究方式,也是制作更高一级证据即系统评价的基础。不但强调在试验设计与施行中充分尊重受试者的权益,从达到的效果来看也符合病人的根本利益。它是临床医务人员淘汰貌似有利实际有害、陈旧过时     

肿瘤患者术中非计划性低体温预防及管理的证据总结

目的 检索并获取肿瘤患者术中非计划性低体温的相关证据,为手术室护理人员提供参考,以降低肿瘤患者术中非计划性低体温的发生率。方法 应用循证建立PICO的方法,针对肿瘤手术患者围术期术中非计划性低体温提出问题,并使用计算机检索关于术中非计划性低体温的高级别证据,包括指南、专家共识、系统评价、随机对照试验研究。结果 共纳入证据13篇,包括临床实践指南2篇,专家共识1篇,系统综述5篇,随机对照试验5篇,最终提取28条证据,总结出15条最佳证据。结论 建议临床医务人员在应用证据时,结合所在临床科室的环境,评估证据应用时的潜在相关资源及其促进和障碍性因素,患者的主观意愿等进行针对性的选择证据。同时,由于研究的不断发展和推进,应用者还应持续对证据进行更新,最终通过应用最佳证据,以科学的护理方法解决肿瘤患者术中非计划性低体温的问题,从而促进护理质量的持续改进,改善患者的临床结局,提升患者的满意度。     

Is one yoga style better than another? A systematic review of associations of yoga style and conclusions in randomized yoga trials

ObjectiveTo determine whether the odds of positive conclusions in randomized controlled trials (RCTs) of yoga, differ between yoga styles.DesignSystematic review of yoga RCTs. Medline/PubMed, Scopus, the Cochrane Library, IndMED and the tables of content of specialist yoga journals, not listed in medical databases, were screened up to 12 February, 2014 for RCTs comparing yoga interventions to non-yoga interventions. The RCTs’ conclusions were classified as positive (yoga is helpful for a respective condition) or not positive; and these were compared between different yoga styles using the Chi squared test and multiple logistic regression analysis.ResultsA total of 306 RCTs were included. These applied 52 different yoga styles, the most commonly used of which were: hatha yoga (36 RCTs), Iyengar yoga (31 RCTs), pranayama (26 RCTs), and the integrated approach to yoga therapy (15 RCTs). Positive conclusions were reached in 277 RCTs (91%); the proportion of positive conclusions did not differ between yoga styles (p = 0.191).ConclusionRCTs with different yoga styles do not differ in their odds of reaching positive conclusions. Given that most RCTs were positive, the choice of an individual yoga style can be based on personal preferences and availability.     

Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine

BackgroundRandomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking.ObjectivesThis paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy.MethodsIdentification of the homeopathy-specific requirements for RCTs by reviewing literature and experts’ communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy.ResultsRecommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented.ConclusionsThe formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.     

颞下颌关节紊乱病治疗的Cochrane系统评价证据

目的评价颞下颌关节紊乱病（TMD）治疗的Cochrane系统评价证据及纳入治疗TMD系统评价的临床随机对照试验（RCT）的方法学质量。方法文献检索Cochrane Library（2008年第3期）中有关TMD治疗的系统评价，并对系统评价纳入RCT的方法学质量进行评价。结果共检索到3篇系统评价：分别为透明质酸钠、咬合调整、稳定咬合板治疗TMD的疗效评价，共纳入25个RCT。按Cochrane协作网推荐的质量评价方法，纳入的RCT中仅2篇为B级，其余23篇研究均为C级。结论目前缺少足够强度的证据来支持透明质酸钠、稳定咬合板、咬合调整治疗TMD的疗效。其他治疗手段的疗效如关节镜等尚需通过进一步完成的系统评价来评估。TMD治疗的系统评价所纳入RCT的方法学质量普遍较低，部分研究存在随机方法描述不清、无隐蔽分组、无样本量计算及无意向治疗分析等缺陷。建议推行临床试验透明化，实施临床试验注册制度，按照CONSORT声明严格规范RCT的报告，以便于总结预防和治疗TMD的临床证据，提高TMD临床治疗水平。     

口腔卫生护理的Cochrane系统评价证据

目的总结有关口腔卫生护理的Cochrane系统评价证据。方法计算机检索Cochrane Library（2008年第3期）中有关口腔卫生护理的系统评价,并进行分析。结果共检索到4篇系统评价,内容涉及：手动与电动牙刷对维护口腔卫生的效果比较,应用牙问隙刷保持固定矫治患者口腔卫生的效果评价,初级121腔卫生护理的复诊间隔的选择,刮舌预防口臭的效果。结论目前缺乏高强度证据来支持牙间隙刷等口腔卫生护理的疗效。其他口腔护理方法的疗效如漱口水等尚需通过进一步的试验来评估。现有口腔卫生护理的系统评价纳入随机对照试验的方法学质量普遍较低,部分研究存在随机方法描述不清、无隐蔽分组、无样本量计算,以及无意向治疗分析等缺陷。建议推行临床试验透明化,实施临床试验注册制度,按照CONSORT声明规范报道随机对照试验,以便总结口腔卫生护理的临床证据,提高口腔卫生护理临床水平。     

Do the observational studies using propensity score analysis agree with randomized controlled trials in the area of sepsis?

Background and objectives

Sepsis is a leading cause of mortality and morbidity in the intensive care unit, and many studies have been conducted aiming to improve its outcome. Randomized controlled trials (RCTs) and observational studies using propensity score (PS) method are commonly used for this purpose. However, the agreement between these two major methodological designs has never been investigated in this specific area. The present study aimed to compare the effect sizes between RCTs and PS-based studies.

Methods

Electronic databases including Pubmed, Scopus, and EBSCO were searched to obtain PS-based studies in the area of sepsis. The studies were matched to RCTs or systematic reviews and meta-analysis in terms of population, intervention, control, and outcome. When there were multiple PS-based studies or RCTs in one area, the effect sizes were pooled by using random-effects model and inverse variance method. The comparisons were performed by using differences in the effect size.

Results

A total of 8 topics were identified fulfilling the criterion that at least 1 pair of RCT and PS-based study could be matched. The interventions included activated protein C, low-dose steroid, antithrombin III, combination antibiotic therapy, fish oil supplementation, statin, etomidate for intubation, and recombinant human soluble thrombomodulin. The effect sizes were statistically different between RCTs and PS-based studies in most circumstances (6/8). The pooled mean difference in effect sizes was − 0.16 (95% confidence interval, − 0.33 to 0.01), indicating a trend towards larger treatment effect in PS studies than in RCTs. The result remains unaltered by restricting to RCTs and PS studies with the largest sample sizes.

Conclusion

Our study shows that PS studies tend to report larger treatment effect than RCTs in the field of sepsis, indicating the difference between efficacy trials and effectiveness studies.     

《北京中医药大学学报》临床治疗试验论文的评价

目的：了解《北京中医药大学学报》临床治疗试验论文的现状和水平,检索出其中属随机对照试验（RCTs）和临床对照试验（CCTs）的论文,为系统评价打基础。方法：按Cochrane中心手检指南逐篇查阅杂志论文。共检索从1981年～1998年共18卷102期杂志。结果：RCTs和CCTs论文占临床治疗试验论文的比例分别为19.42%、10.79%。RCTs论文90年代较80年代大幅增加,尤其近三年递增明显。CCTs论文比例无显著变化。结论：《北京中医药大学学报》临床治疗试验论文中RCTs、CCTs论文比例偏低,但近年来RCTs论文比例有大幅增加。论文撰写方面尚有许多不足需要改进。     

RCTs in complex nursing interventions and laboratory experimental studies

The randomised controlled trial (RCT) is at the heart of the evidence-based medicine movement and by implication should also be central to evidence-based nursing. One objection to RCTs in nursing science is that nursing is too complex an activity to be subjected to a carefully controlled experimental paradigm. We suggest that this argument is false and use examples from complex interventions research in nursing and experimental laboratory methods to demonstrate that RCTs can bring much needed clarity to the search for nursing knowledge.     

中西医结合治疗严重急性呼吸综合征的随机对照试验质量调查

目的：调查中西医结合治疗严重急性呼吸综合征(severe acute：respiratory syndrome，SARS)的随机对照试验的真实性。方法：通过电子检索、手工检索并无语种限制地检索全世界中西医结合治疗SARS的随机对照试验(randomized controlledtrial，RCT)。借鉴Cochrane的质量分级法，调查RCT的方法学质量，并从样本量、基线资料、结局指标等方面分析RCT质量。结果：共检索到7篇中西医结合治疗SARS的RCTs，1篇质量等级为B，其余5篇质量等级皆为C。没有一篇RCT进行样本量估计；仅1篇RCT的基线资料经统计学检验无差异；1篇献结局指标包括了生活质量；没有1篇献报告副性事件。7篇RCTs共纳入SARS病人501例。另有3篇因未发表尚未获得全。讨论：目前所获得的RCTs真实性不够高，不能为临床实践提供充分、可靠的证据。     

Effectiveness of rehabilitation based on recreational activities: A systematic review

AIM: To summarize the evidence from randomized controlled trials (RCTs) on the rehabilitation effects of recreational activities. METHODS: Studies were eligible if they were RCTs. Studies included one treatment group in which recreational activity was applied. We searched the following databases from 1990 to May 31, 2012: MEDLINE via PubMed, CINAHL, Web of Science, and Ichushi-Web. We also searched all Cochrane Databases and Campbell Systematic Reviews up to May 31, 2012. RESULTS: Eleven RCTs were identified, which included many kinds of target diseases and/or symptoms such as stroke, dementia, Parkinson’s disease, acquired brain injury, chronic non-malignant pain, adolescent obesity, high-risk pregnancy, and the frail elderly. Various intervention methods included gaming technology, music, dance, easy rider wheelchair biking, leisure education programs, and leisure tasks. The RCTs conducted have been of relatively low quality. A meta-analysis (pooled sample; n = 44, two RCTs) for balance ability using tests such as “Berg Balance Scale” and “Timed Up and Go Test” based on game intervention revealed no significant difference between interventions and controls. In all other interventions, there were one or more effects on psychological status, balance or motor function, and adherence as primary or secondary outcomes. CONCLUSION: There is a potential for recreational activities to improve rehabilitation-related outcomes, particularly in psychological status, balance or motor function, and adherence.     

国内中医药非劣效/等效性随机对照试验报告质量评价

目的评价当前中医药非劣效/等效性随机对照试验(RCT)的报告质量。方法计算机检索中医药研究中采用非劣效/等效性试验设计的RCT报告,参照CONSORT声明扩展版——非劣效和等效性随机对照试验的报告标准对纳入的报告进行质量评价。结果共纳入中医药非劣效/等效性RCT报告13篇。报告质量除存在一般RCT常见问题以外,非劣效/等效性试验相关的一些内容报告不够充分:①文题不能反映文献的最重要内容;②背景的介绍比较简单,未明确非劣效/等效性试验的理论基础、参照处理(阳性对照)的有效性等;③全部文献均未说明非劣效/等效性试验的受试者、干预措施和结局是否与既往确立参照处理有效性的试验中用到的相似或相同;④大部分文献未确定非劣效/等效性界值,未进行样本含量的估算;⑤仅半数文献对非劣效/等效性检验方法有所描述;⑥部分文献存在误下非劣效/等效性结论的问题。结论研究者对非劣效/等效性试验理论基础的认识仍需深入,参照CONSORT声明的扩展——非劣效和等效性随机对照试验的报告标准,有助于研究者明确非劣效/等效性RCT设计、实施和报告的重点,重视非劣效/等效性试验报告的相关内容,从根本上提高此类临床试验报告的质量。