cochrane评分表
cochrane评分表

Risk of biasItem Authors'judgementDescriptionAdequate sequence generation? Yes Prinicipal author stated thatcomputer generatedallocation was usedAllocation concealment? Yes Prinicipal author stated thatallocation was concealedBlinding? Unclear No mention of study personnelor participants being blindto treatment groupIncomplete outcome data addressed? Yes All participants accountedfor, one 'drop out' recordedbut included by us in analysisFree of other bias? Unclear Possible uneven distributionof complete and incompleteparalysis at start of studybetween the two treatmentgroupsCochrane RCT质量评价标准:①随机方法是否正确。
②是否隐蔽分组。
③盲法的使用情况。
④失访或退出描述情况,有无采用意向性(ITT)分析。
以上质量标准中,如所有标准均为“充分”,则发生各种偏倚的可能性很小;如其中一条为不清楚,则有发生相应偏倚的中等度可能性;如其中一条为“不充分”或“未采用”,则有发生相应偏倚的高度可能性。
可参见:RCT的质量评价标准选择总结/bbs/topic/18137535?tpg=1&age=-1Quality assessmentThe quality of the trials was assessed and graded independently by two authors according to the criteria described in The Cochrane Handbook 4.2.6 (Higgins 2006). Gradings were compared and any inconsistencies between the authors in the interpretation of inclusion criteria and their significance to the selected study were discussed and resolved.The selected study was assessed for the following characteristics:1. The adequacy of the randomisation process (possible selection bias). Adequate randomisation includes any one of the following methods: computer generated or table of random numbers, drawing of lots, coin-toss, shuffling cards or throw of a dice. Inadequate methods of randomisation include the following: case record number, date of birth or alternate numbers.2. The adequacy of the allocation concealment (possible selection bias). Adequate methods of allocation concealment include either central randomisation (i.e. separate to other aspects of trial administration) or sequentially numbered sealed opaque envelopes. Inadequate concealment means an open allocation sequence in which either participants or trialists were able to foresee the upcoming assignment.3. The blinding of outcome assessors (i.e. whether the persons assessing the outcome of care were aware of which treatment the participant had received - possible performance bias).4. The extent and handling of losses to follow up (possible attrition bias). Adequate handling of losses to follow up involves a clear description and explanation being given of any significant difference between the losses of the intervention groups. An unacceptable loss in any one intervention group was considered to be loss greater than 20%.Study gradings A, B or C were employed for overall quality as follows.A: Minimisation of bias in all four categories above: i.e. adequate randomisation, few losses to follow up and intention-to-treat analysis, blinding of outcome assessors, high quality outcome assessment;B: Each of the criteria in A partially met;C: One or more of the criteria in A not met.Risk of bias in included studiesWe classified this study as grade C because of the uncertainty about blinding. The possibility of an uneven distribution of complete and incomplete palsies between the two groups is another potential source of bias and we conclude overall that this is a low quality study.Table 8.5.a: The Cochrane Collaboration’s tool for assessi ng risk of biasTable 8.5.c: Criteria for judging risk of bias in the ‘Risk of bias’ assessment toolFigure 8.6.a: Example of a ‘Risk of bias’ table for a single study (fictional)Table 8.7.a: Possible approach for summary assessments of the risk of bias for each important outcome (across domains) within and across studies。
COCHRANE系统评价计划书

COCHRANE系统评价计划书1. 简介COCHRANE(协作网)是世界范围内最具影响力的提供可信赖的医学证据的机构之一。
COCHRANE系统评价是一种对医学研究进行全面综合分析的方法,旨在提供最可靠、最全面的证据来指导临床实践和政策制定。
本文档旨在概述COCHRANE系统评价计划的目的、方法和预期结果。
2. 计划目的本计划旨在通过COCHRANE系统评价来回答以下研究问题:[填写具体研究问题]。
通过对现有的研究进行综合分析,我们希望能够提供对该问题的最可靠的证据,以便指导医疗决策和改善患者的治疗结果。
3. 计划方法3.1 检索策略我们将通过系统检索的方式收集与研究问题相关的文献。
检索策略将包括关键词和限制条件的应用,以确保只有满足特定标准的研究被纳入综合分析。
3.2 研究选择根据预定的纳入和排除标准,我们将筛选符合条件的研究。
纳入标准将包括[填写具体纳入标准],排除标准将包括[填写具体排除标准]。
研究选择将由两个独立的评审员进行,如有争议将通过讨论或第三位评审员进行决定。
3.3 数据提取我们将从纳入的研究中提取必要的数据,并进行质量评估。
数据提取将由两个独立的评审员进行,以确保数据的准确性和一致性。
3.4 数据分析我们将采用统计学分析方法对纳入的研究进行综合分析。
根据研究设计和数据类型的不同,我们将选择合适的分析方法,如荟萃分析、子组分析等。
4. 预期结果通过COCHRANE系统评价,我们预计将得出对研究问题的最可靠的证据。
这包括对干预措施的有效性、安全性和成本效益的评估。
我们将根据预定的终点指标,如临床结局、生活质量等,提供定量或定性的结果。
5. 计划时间表本计划的时间表如下:•检索策略制定和文献检索:[填写具体时间]•研究选择和数据提取:[填写具体时间]•数据分析和结果呈现:[填写具体时间]•最终报告编写和提交:[填写具体时间]6. 计划团队本计划的执行需要一个专业的团队,包括研究者、信息专家、统计学家等。
(完整版)cochrane纳入的RCT文献质量评价中文版

洗牌的卡片和信封
掷骰子
抽签
最小化
*最小化,可实现无随机元素,被认为相当于是随机的。
判断为高风险的标准
研究者描述序列的产生使用的是非随机的方法。通常是系统的非随机方法,例如:
通过奇偶或出生日期产生序列
通过入院日期产生序列
通过类似住院号或门诊号产生序列
相对于上面提到的系统方法,其它非随机的方法少见的多,也更明显。通常包括对参与者进行判断或非随机的方法,例如:
研究未描述此情况
选择性发表
选择性发表导致发表偏倚
偏倚低风险标准
任何如下标准:
实验的计划书可获取,系统评价感兴趣的所有首要或次要结局均按计划书预先说明的方式报道
实验计划书不可得,但很明显发表的报告包括所有的结局,包括预先说明的结局(这种性质的有说服力的文字可能少见)
高风险判断标准
任何如下标准:
不是所有的预先说明的首要结局均被报道
尝试对关键的参与者和实施者行盲法,但盲法很可能被打破,结局很可能受到缺乏盲法的影响
风险未知
任何如下标准:
没有足够信息判断为低风险或高风险
研究未描述此情况
结局数据不完整
不全结局数据的数量,性质,处理方式导致失访偏倚
偏倚低风险标准
任何如下标准:
无缺失数据
缺失数据的产生不大可能与真实结局相关(对于生存数据,删失不大可能引入偏倚)
Table 8.5.a: The Cochrane Collaboration’s tool for assessing risk of bias
偏倚类型
判断指标
评价员的判断
选择偏倚
随机序列的产生
足够详细的描述用于生成分配序列的方法,以评估产生的分组是否具有可比性。
cochrane纳入的RCT文献质量评价(风险偏倚评估工具)中英文对照版

交替或循环
出生日期
病历号
其它明确的非隐藏过程
风险未知
没有足够信息判断为低风险或高风险。通常因分配隐藏的方法未描述或描述不充分。例如描述为使用信封分配,但为描述信封是否透明?密封?顺序编号?
对参与者和实施者的盲法
因参与者和实施者了解干预情况而导致实施偏倚
低风险判断标准
参与者以及纳入参与者的研究者因以下掩盖分配的方法或相当的方法,事先不了解分配情况
中心分配(包括电话,网络,药房控制随机)
相同外形的顺序编号的药物容器;
顺序编号、不透明、密封的信封
高风险判断标准
参与者以及纳入参与者的研究者可能事先知道分配,因而引入选择偏倚,譬如基于如下方法的分配:
使用摊开的随机分配表(如随机序列清单)
Selectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.
Performancebias.
BlindingofparticipantsandpersonnelAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).?
可能存在偏倚风险,但存在以下两种中的一种
没有足够信息评估是否存在其它重要的偏倚风险
没有足够的证据认为发现的问题会引入偏倚
summaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossdomains)withinandacrossstudies
cochrane文献评价手册

Cochrane文献评价手册在医学和健康领域,Cochrane文献评价手册是一个备受推崇的参考资料。
它是一个致力于提供高质量、广度和深度兼具的文献评价和系统评价信息的权威评台。
通过对临床试验和其他医学研究进行全面评估和分析,Cochrane文献评价手册为医生、医学研究者和患者提供了宝贵的参考意见。
在Cochrane文献评价手册中,我们可以查找到各种主题的文献评价和系统评价,涵盖了从疾病预防到治疗、康复的各个方面。
无论是针对特定疾病、特定干预措施或特定人群的研究,Cochrane文献评价手册都提供了可靠的信息和意见,帮助人们做出更明智的医疗决策。
对于医学研究者来说,Cochrane文献评价手册提供了一个值得借鉴和学习的标准。
他们可以通过查阅Cochrane文献评价手册,了解到如何进行高质量的文献评价和系统评价,以及如何准确地汇总和分析研究结果。
这有助于提高他们的学术水平,促进医学研究的发展和进步。
对于医生和医疗工作者来说,Cochrane文献评价手册则是一个宝贵的临床参考工具。
他们可以在这里找到与自己临床实践相关的最新研究成果和最可靠的证据,以指导自己的临床决策。
这有助于提高临床实践的质量,保证患者获得更好的医疗服务。
对于患者和公众来说,Cochrane文献评价手册提供了一个可靠的信息来源。
他们可以在这里了解到关于自己健康问题的最新研究成果和治疗建议,从而更好地了解自身疾病,做出更明智的健康决策。
Cochrane文献评价手册是一个对医学研究、临床实践和健康决策都具有重要意义的权威评台。
它以其高质量、深度和广度兼具的文献评价和系统评价信息,为医学领域的各个参与者提供了宝贵的帮助和指导。
相信随着医学研究的不断进步和发展,Cochrane文献评价手册将为我们带来更多的惊喜和启发。
Cochrane文献评价手册作为权威评台,其对医学领域具有重要意义的确无庸置疑。
在现代医学研究中,由于信息的爆炸性增长和研究成果的不断涌现,医生和研究者需要一个可靠的参考工具来指导他们的决策和实践。
cochrane纳入的RCT文献质量评价(风险偏倚评估工具)中英文对照版

中文:Table 8.5.a: The Cochrane Collaboration’s tool for assessing risk of biasTable 8.5.d: Criteria for judging risk of bias in the ‘Risk of bias’ assessment tool研究者描述随机序列产生过程譬如:参考随机数字表使用计算机随机数字生成器扔硬币洗牌的卡片和信封掷骰子抽签最小化*最小化,可实现无随机元素,被认为相当于是随机的。
研究者描述序列的产生使用的是非随机的方法。
通常是系统的非随机方法,例如:通过奇偶或出生日期产生序列通过入院日期产生序列通过类似住院号或门诊号产生序列相对于上面提到的系统方法,其它非随机的方法少见的多,也更明显。
通常包括对参与者进行判断或非随机的方法,例如:临床医生判断如何分配参与者判断如何分配基于实验室检查或系列测试的结果分配基于干预的可获取性进行分配中心分配(包括电话,网络,药房控制随机)相同外形的顺序编号的药物容器;顺序编号、不透明、密封的信封参与者以及纳入参与者的研究者可能事先知道分配,因而引入选择偏倚,譬如基于如下方法的分配:使用摊开的随机分配表(如随机序列清单)分发信封但没有合适的安全保障(如透明、非密封、非顺序编号)交替或循环出生日期病历号其它明确的非隐藏过程任何如下标准:无盲法或盲法不充分,但系统评价员判断结局不太可能受到缺乏盲法的影响参与者和主要实施者均实施可靠的盲法,且盲法不太可能被打破任何如下标准:无盲法或盲法不充分,但系统评价员判断结局很可能受到缺乏盲法的影响尝试对关键的参与者和实施者行盲法,但盲法很可能被打破,结局很可能受到缺乏盲法的影响任何如下标准:没有足够信息判断为低风险或高风险研究未描述此情况任何如下标准:无盲法或盲法不充分,但系统评价员判断结局不太可能受到缺乏盲法的影响参与者和主要实施者均实施可靠的盲法,且盲法不太可能被打破任何如下标准:无盲法或盲法不充分,但系统评价员判断结局很可能受到缺乏盲法的影响尝试对关键的参与者和实施者行盲法,但盲法很可能被打破,结局很可能受到缺乏盲法的影响任何如下标准:没有足够信息判断为低风险或高风险研究未描述此情况任何如下标准:无缺失数据缺失数据的产生不大可能与真实结局相关(对于生存数据,删失不大可能引入偏倚)缺失数据的数目在各干预组相当,且各组缺失原因类似对二分类变量,与观察事件的发生风险相比,缺失比例不足以影响预估的干预效应对连续性结局数据,缺失数据的合理效应规模(均数差或标准均数差)不会大到影响观察的效应规模;缺失的数据用合适的方法进行估算任何如下标准:缺失数据的产生很大可能与真实结局相关, 缺失数据的数目及缺失原因在各干预组相差较大对二分类变量,与观察事件的发生风险相比,缺失比例足以影响预估的干预效应对连续性结局数据,缺失数据的合理效应规模(均数差或标准均数差)足以影响观察的效应规模;意向治疗分析中存在实际干预措施与随机分配的干预相违背的情况对缺失数据进行简单的不合适的估算任何如下标准:没有报道缺失或排除的情况,无法判断高风险或低风险(如未说明随机的数量,未提供数据缺失的原因)研究未描述此情况任何如下标准:实验的计划书可获取,系统评价感兴趣的所有首要或次要结局均按计划书预先说明的方式报道实验计划书不可得,但很明显发表的报告包括所有的结局,包括预先说明的结局(这种性质的有说服力的文字可能少见)任何如下标准:不是所有的预先说明的首要结局均被报道一个或多个首要结局为采用预先说明的测量方法、分析方法或数据子集来报道系统评价感兴趣的一个或多个首要结局报道不全,以至于不能纳入meta分析研究未报道此研究应当包含的主要关键结局具有与特殊试验设计相关的潜在偏倚来源或被指欺诈或其它问题可能存在偏倚风险,但存在以下两种中的一种没有足够信息评估是否存在其它重要的偏倚风险没有足够的证据认为发现的问题会引入偏倚Table 8.7.a: Possible approach for summary assessments of the risk of bias for each important outcome (across domains) within and across studies英文:Table 8.5.a: The Cochrane Collaboration’s tool for assessing risk of biasTable 8.5.d: Criteria for judging risk of bias in the ‘Risk of bias’ assessment toolprocess such as:Referring to a random number table;Using a computer random number generator;Coin tossing;Shuffling cards or envelopes;Throwing dice;Drawing of lots;Minimization*.*Minimization may be implemented without a random element, and this isconsidered to be equivalent to being random.judgement The investigators describe a non-random component in the sequence generation process. Usually, the description would involve somesystematic, non-random approach, for example:Sequence generated by odd or even date of birth;Sequence generated by some rule based on date (or day) of admission;Sequence generated by some rule based on hospital or clinic recordnumber.Other non-random approaches happen much less frequently than thesystematic approaches mentioned above and tend to be obvious. Theyusually involve judgement or some method of non-random categorization ofparticipants, for example:Allocation by judgement of the clinician;Allocation by preference of the participant;Allocation based on the results of a laboratory test or a seriesof tests;Allocation by availability of the intervention.Criteria for a judgement Participants and investigators enrolling participants could not foreseeassignment because one of the following, or an equivalent method, was usedto conceal allocation:Central allocation (including telephone, web-based andpharmacy-controlled randomization);Sequentially numbered drug containers of identical appearance;Sequentially numbered, opaque, sealed envelopes.judgement Participants or investigators enrolling participants could possiblyforesee assignments and thus introduce selection bias, such as allocationbased on:Using an open random allocation schedule (e.g. a list of randomnumbers);Assignment envelopes were used without appropriate safeguards(e.g. if envelopes were unsealed or nonopaque or not sequentiallynumbered);Alternation or rotation;Date of birth;Case record number;Any other explicitly unconcealed procedure.Criteria for a judgement Any one of the following:No blinding or incomplete blinding, but the review authors judgethat the outcome is not likely to be influenced by lack of blinding;Blinding of participants and key study personnel ensured, andunlikely that the blinding could have been broken.judgementAny one of the following:No blinding or incomplete blinding, and the outcome is likely tobe influenced by lack of blinding;Blinding of key study participants and personnel attempted, butlikely that the blinding could have been broken, and the outcomeis likely to be influenced by lack of blinding.judgement ‘Unclear risk’ ofAny one of the following:Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’;The study did not address this outcome.Criteria for a judgement Any one of the following:No blinding of outcome assessment, but the review authors judge thatthe outcome measurement is not likely to be influenced by lack ofblinding;Blinding of outcome assessment ensured, and unlikely that theblinding could have been broken.judgementAny one of the following:No blinding of outcome assessment, and the outcome measurement islikely to be influenced by lack of blinding;Blinding of outcome assessment, but likely that the blinding couldhave been broken, and the outcome measurement is likely to beinfluenced by lack of blinding.judgement ‘Unclear risk’ ofAny one of the following:Insufficient information to permit judgement of ‘Low risk’ or‘High risk’;The study did not address this outcome.Criteria for a judgement Any one of the following:No missing outcome data;Reasons for missing outcome data unlikely to be related to trueoutcome (for survival data, censoring unlikely to be introducingbias);Missing outcome data balanced in numbers across interventiongroups, with similar reasons for missing data across groups;For dichotomous outcome data, the proportion of missing outcomescompared with observed event risk not enough to have a clinicallyrelevant impact on the intervention effect estimate;For continuous outcome data, plausible effect size (difference inmeans or standardized difference in means) among missing outcomesnot enough to have a clinically relevant impact on observed effectsize;Missing data have been imputed using appropriate methods.judgement Any one of the following:Reason for missing outcome data likely to be related to trueoutcome, with either imbalance in numbers or reasons for missingdata across intervention groups;For dichotomous outcome data, the proportion of missing outcomescompared with observed event risk enough to induce clinicallyrelevant bias in intervention effect estimate;For continuous outcome data, plausible effect size (difference inmeans or standardized difference in means) among missing outcomesenough to induce clinically relevant bias in observed effect size;‘As-treated’ analysis done with substantial departure of theintervention received from that assigned at randomization;Potentially inappropriate application of simple imputation.judgement ‘Unclear risk’ ofAny one of the following:Insufficient reporting of attrition/exclusions to permit judgement of ‘Low risk’ or ‘High risk’ (e.g. number ran domized not stated,no reasons for missing data provided);The study did not address this outcome.Criteria for a judgement Any of the following:The study p rotocol is available and all of the study’spre-specified (primary and secondary) outcomes that are of interestin the review have been reported in the pre-specified way;The study protocol is not available but it is clear that thepublished reports include all expected outcomes, including thosethat were pre-specified (convincing text of this nature may beuncommon).judgementAny one of the following:Not all of the study’s pre -specified primary outcomes have beenreported;One or more primary outcomes is reported using measurements,analysis methods or subsets of the data (e.g. subscales) that werenot pre-specified;One or more reported primary outcomes were not pre-specified(unless clear justification for their reporting is provided, suchas an unexpected adverse effect);One or more outcomes of interest in the review are reportedincompletely so that they cannot be entered in a meta-analysis;The study report fails to include results for a key outcome thatwould be expected to have been reported for such a study.judgementThere is at least one important risk of bias. For example, the study: Had a potential source of bias related to the specific study designused; orHas been claimed to have been fraudulent; orHad some other problem.judgement ‘Unclear risk’ ofThere may be a risk of bias, but there is either:Insufficient information to assess whether an important risk of bias exists; orInsufficient rationale or evidence that an identified problem willintroduce bias.Table 8.7.a: Possible approach for summary assessments of the risk of bias for each important outcome (across domains) within and across studies。
Cocharane偏倚风险评估表

很可能受缺乏盲法的影响
风险不清楚
信息不充分不足以判断“低风险”或“高风险”
研究未提及这一结果
对结果评价
者施盲
低风险
无盲法,但系统评价者判断结果测量不太可能因缺乏盲法而受影响
确保对结果评价者施盲,并且不太可能破盲
高风险
无盲法,但系统评价者判断该结果测量很可能受缺乏盲法的影响
对于二分类结果数据,与观察的事件风险相比,缺失结果数据的比例足以对干预效应估计产生临床相关影响
对于连续性结果数据,缺失结果数据中似真的效应大小(均数差或标准均数差)足以对观测效应大小产生临床相关影响
采用“视为治疗(as-treated)”分析,但改变随机入组时干预措施的人数较多
可能不恰当地使用简单估算方法
风险不清楚
关于随机序列产生过程的信息不充分不足以判断“低风险”或“高风险”
分配隐藏
低风险
中心化分配(包括电话、基于网络和药房控制的随机化)
同一外观、连续编号的药物容器
按顺序编号、不透光、密封的信封
高风险
使用开放的随机分配表(如随机数字清单)
使用无适当保护措施的分配信封(如信封未密封、透光信封、
信封未按顺序编号)
风险不清楚
报告减员/排除的信息不充分不足以判断“低风险”或“高风险(如随机人数未说明,未提供缺失数据的原因)
研究未提及这一结果
选择性结果
报告
低风险
有研究方案,且系统评价关心的方案中预先指定的(主要和次要)结果指标均有报告
没有研究方案,但所有期望的结局指标,包括在发表文章中预先指定的指标均有报告
高风险
对于二分类结果数据,与观察的事件风险相比,缺失结果数据的比例不足以对干预效应估计产生临床相关影响
cochrane评分表

Risk of biasItem Authors'judgementDescriptionAdequate sequence generation? Yes Prinicipal author stated thatcomputer generatedallocation was usedAllocation concealment? Yes Prinicipal author stated thatallocation was concealedBlinding? Unclear No mention of study personnelor participants being blindto treatment groupIncomplete outcome data addressed? Yes All participants accountedfor, one 'drop out' recordedbut included by us in analysisFree of other bias? Unclear Possible uneven distributionof complete and incompleteparalysis at start of studybetween the two treatmentgroupsCochrane RCT质量评价标准:①随机方法是否正确。
②是否隐蔽分组。
③盲法的使用情况。
④失访或退出描述情况,有无采用意向性(ITT)分析。
以上质量标准中,如所有标准均为“充分”,则发生各种偏倚的可能性很小;如其中一条为不清楚,则有发生相应偏倚的中等度可能性;如其中一条为“不充分”或“未采用”,则有发生相应偏倚的高度可能性。
可参见:RCT的质量评价标准选择总结/bbs/topic/18137535?tpg=1&age=-1Quality assessmentThe quality of the trials was assessed and graded independently by two authors according to the criteria described in The Cochrane Handbook 4.2.6 (Higgins 2006). Gradings were compared and any inconsistencies between the authors in the interpretation of inclusion criteria and their significance to the selected study were discussed and resolved.The selected study was assessed for the following characteristics:1. The adequacy of the randomisation process (possible selection bias). Adequate randomisation includes any one of the following methods: computer generated or table of random numbers, drawing of lots, coin-toss, shuffling cards or throw of a dice. Inadequate methods of randomisation include the following: case record number, date of birth or alternate numbers.2. The adequacy of the allocation concealment (possible selection bias). Adequate methods of allocation concealment include either central randomisation (i.e. separate to other aspects of trial administration) or sequentially numbered sealed opaque envelopes. Inadequate concealment means an open allocation sequence in which either participants or trialists were able to foresee the upcoming assignment.3. The blinding of outcome assessors (i.e. whether the persons assessing the outcome of care were aware of which treatment the participant had received - possible performance bias).4. The extent and handling of losses to follow up (possible attrition bias). Adequate handling of losses to follow up involves a clear description and explanation being given of any significant difference between the losses of the intervention groups. An unacceptable loss in any one intervention group was considered to be loss greater than 20%.Study gradings A, B or C were employed for overall quality as follows.A: Minimisation of bias in all four categories above: i.e. adequate randomisation, few losses to follow up and intention-to-treat analysis, blinding of outcome assessors, high quality outcome assessment;B: Each of the criteria in A partially met;C: One or more of the criteria in A not met.Risk of bias in included studiesWe classified this study as grade C because of the uncertainty about blinding. The possibility of an uneven distribution of complete and incomplete palsies between the two groups is another potential source of bias and we conclude overall that this is a low quality study.Table 8.5.a: The Cochrane Collaboration’s tool for assessi ng risk of biasTable 8.5.c: Criteria for judging risk of bias in the ‘Risk of bias’ assessment toolFigure 8.6.a: Example of a ‘Risk of bias’ table for a single study (fictional)Table 8.7.a: Possible approach for summary assessments of the risk of bias for each important outcome (across domains) within and across studies。
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Risk of bias
Item Authors'
judgement
Description
Adequate sequence generation? Yes Prinicipal author stated that
computer generated
allocation was used
Allocation concealment? Yes Prinicipal author stated that
allocation was concealed
Blinding? Unclear No mention of study personnel
or participants being blind
to treatment group
Incomplete outcome data addressed? Yes All participants accounted
for, one 'drop out' recorded
but included by us in analysis
Free of other bias? Unclear Possible uneven distribution
of complete and incomplete
paralysis at start of study
between the two treatment
groups
Cochrane RCT质量评价标准:
①随机方法是否正确。
②是否隐蔽分组。
③盲法的使用情况。
④失访或退出描述情况,有无采用意向性(ITT)分析。
以上质量标准中,如所有标准均为“充分”,则发生各种偏倚的可能性很小;如其中一条为不清楚,则有发生相应偏倚的中等度可能性;如其中一条为“不充分”或“未采用”,则有发生相应偏倚的高度可能性。
可参见:
RCT的质量评价标准选择总结
/bbs/topic/18137535?tpg=1&age=-1
Quality assessment
The quality of the trials was assessed and graded independently by two authors according to the criteria described in The Cochrane Handbook 4.2.6 (Higgins 2006). Gradings were compared and any inconsistencies between the authors in the interpretation of inclusion criteria and their significance to the selected study were discussed and resolved.
The selected study was assessed for the following characteristics:
1. The adequacy of the randomisation process (possible selection bias). Adequate randomisation includes any one of the following methods: computer generated or table of random numbers, drawing of lots, coin-toss, shuffling cards or throw of a dice. Inadequate methods of randomisation include the following: case record number, date of birth or alternate numbers.
2. The adequacy of the allocation concealment (possible selection bias). Adequate methods of allocation concealment include either central randomisation (i.e. separate to other aspects of trial administration) or sequentially numbered sealed opaque envelopes. Inadequate concealment means an open allocation sequence in which either participants or trialists were able to foresee the upcoming assignment.
3. The blinding of outcome assessors (i.e. whether the persons assessing the outcome of care were aware of which treatment the participant had received - possible performance bias).
4. The extent and handling of losses to follow up (possible attrition bias). Adequate handling of losses to follow up involves a clear description and explanation being given of any significant difference between the losses of the intervention groups. An unacceptable loss in any one intervention group was considered to be loss greater than 20%.
Study gradings A, B or C were employed for overall quality as follows.
A: Minimisation of bias in all four categories above: i.e. adequate randomisation, few losses to follow up and intention-to-treat analysis, blinding of outcome assessors, high quality outcome assessment;
B: Each of the criteria in A partially met;
C: One or more of the criteria in A not met.
Risk of bias in included studies
We classified this study as grade C because of the uncertainty about blinding. The possibility of an uneven distribution of complete and incomplete palsies between the two groups is another potential source of bias and we conclude overall that this is a low quality study.
Table 8.5.a: The Cochrane Collaboration’s tool for assessi ng risk of bias
Table 8.5.c: Criteria for judging risk of bias in the ‘Risk of bias’ assessment tool
Figure 8.6.a: Example of a ‘Risk of bias’ table for a single study (fictional)
Table 8.7.a: Possible approach for summary assessments of the risk of bias for each important outcome (across domains) within and across studies。