整群随机对照试验(Cluster-randomized control trials, CRCT)报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)扩展版——概述

发布于 2023年4月26日 星期三 12:53:08 浏览:1699
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在临床研究中,当干预措施实施的对象不是个体而是群体的时候,一般使用整群随机对照试验(cluster-randomized control trials, CRCT)。临床试验报告的统一标准(consolidated standards of reporting trials,CONSORT)整群随机对照试验扩展版可以用来指导该类试验的报告。本文概述整群随机对照试验报告规范CONSORT扩展版相关内容。

关键词:整群随机对照试验; 报告规范; 临床试验报告的统一标准; CONSORT扩展版

一、整群随机对照试验报告规范背景

整群随机对照试验(cluster-randomized control trials, CRCT)是以具有某些共同特征个体构成的群体(如家庭、社区、医疗机构等)作为研究对象,随机(单纯随机、分层随机等)将整个群体分配到不同处理组后,对其进行干预、随访,并比较不同处理组效应的研究方法。

部分医疗卫生干预很难在以个体为单位进行随机分组的试验中进行,如对社区人群的健康教育、对医生进行相关指南实施情况的干预等,此时需要在群体水平下进行实施干预,可以更好地避免不同干预在个体间的沾染(contamination)。因此,整群随机对照试验目前广泛应用于健康教育、健康行为、卫生保健制度等非治疗性干预措施的评价中,但整群随机试验在设计、实施和分析上比个体化随机试验更为复杂。

1997年,EIbourne提出整群随机对照试验的报告需要专门的指南;2001年,Elbourne和Campbell对CONSORT声明进行了修改,提出了两水平、完全随机化的整群随机对照试验报告规范的讨论版;2004年,整群随机对照试验的CONSORT声明正式发表,包括1个清单和1个流程图。2012年发表的《CONSORT 2010声明:整群随机试验扩展版》对CONSORT 2010声明清单中的16个条目、CONSORT摘要清单中的8个条目和流程图进行了修订扩展。

二、整群随机对照试验CONSORT扩展版条目清单及流程图

(一) 整群随机对照试验CONSORT扩展版条目清单

表1 整群随机对照试验CONSORT扩展版的条目清单中英文对照

内容条目序号标准清单内容群设计的扩展内容
Title and abstract
标题与摘要
1aIdentification as a randomizedtrial in the title
在题目中体现随机化试验
Identification as a cluster randomized trial in the title
在题目中体现整群随机化试验
1bStructured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)
结构化摘要,包括试验设计、方法、结果和结论(详见CONSORT摘要)
See Table 2
见表2
Introduction
引言
Background and objectives
背景和目的
2aScientific background and explanation of rationale
研究的科学背景和试验的理由
Rationale for using a cluster design
使用整群设计的原因
2bSpecific objectives or hypotheses
研究目的或假设
Whether objectives pertain to the cluster level, the individual participant level, or both
研究目的是针对群体水平、个体水平,还是两者均有
Methods
方法
Trial design
试验设计
3aDescription of trial design ( such as parallel, factorial ), including allocation ratio
试验设计(如平行、析因设计),包括分配比
Definition of cluster and description of how the design features apply to the clusters
群的定义,描述设计特征如何应用到群
3bImportant changes to methods after trial commencement ( such as eligibility criteria ), with reasons
试验开始后方法上的重要改变(如研究对象选标准的改变)及原因
 
Participants
研究对象
4aEligibility criteria for participants
研究对象的纳入排除标准
Eligibility criteria for clusters
群的纳入排除标准
4bSettings and locations where the data were collected
数据收集的机构和地点
 
    
Interventions
干预
5The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
各组干预的详细内容,包括何时、如何实际开展,以便能够重复
Whether interventions pertain to the cluster level, the individual participant level, or both
干预在群水平、个体水平实施,还是两者均有
Outcomes
结局
6aCompletely defined prespecified primary and secondary outcome measures, including how and when they were assessed
完整明确地定义预先规定的主要和次要结局指标,包括何时、如何评价
Whether outcome measures pertain to the cluster level, the individual participant level, or both
结局指标针对群水平、个体水平,还是两者均有
6bAny changes to trial outcomes after the trial commenced, with reasons
试验开始后结局的改变及原因
 
Sample size
样本量
7aHow sample size was determined
样本量如何确定
Method of calculation, number of cluster (s)( and whether equal or unequal cluster sizes are assumed), cluster size a coefficient of intracluster correlation( ICC or k ), and an indication of its uncertainty
计算方法,群数量(各群大小是否相同),群大小,群内相关系数(ICC或k)及其不确定性的指标
7bWhen applicable, explanation of any interim analyses and stopping guidelines
对期中分析和中止试验的条件进行解释(如适用)
 
Randomization
随机化
Sequence generation
序列产生
8aMethod used to generate the random allocation sequence
产生随机分配序列的方法
 
8bType of randomization; details of any restriction ( such as blocking and block size )
随机化类型;任何限定情况(如区组和区组大小)
Details of stratification or matching if used
分层或匹配的详细信息(若适用)
Allocation concealment mechanism
分配隐藏机制
9Mechanism used to implement the random allocation sequence( such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
实施随机序列的方法(如连续编码的容器),阐明隐藏分配序列的措施
Specification that allocation was based on clusters rather individuals and whether allocation concealment ( if any ) was at the cluster level, the individual participant level, or both
阐明分配基于群而不是个体,以及分配隐藏是在群水平、个体水平还是两个水平上实施的(若适用)
Implementation
实施
10Who generated the random allocation sequence, who enrolled participants , and who assigned participants to interventions
产生分配序列、纳入研究对象、分配研究对象的人员
Replaced by 10a,10b,and 10c
由10a、10b和10c替代
10a Who generated the random allocation sequence, who enrolled clusters, and who assigned clusters to interventions
谁产生分配序列,谁招募群,谁给研究对象分配干预措施
10b Mechanism by which individual participants were included in clusters for the purposes of the trial ( such as complete enumeration, random sampling
个体被纳入群组的机制(如全部纳入或随机抽样)
10c From who consent was sought ( representatives of the cluster, or individual cluster members, or both ) and whether consent was sought before or after randomisation
知情同意(群代表,或群内所有个体,或两者均有),获得同意是在随机化之前还是之后
Blinding
盲法
11aIf done, who was blinded after assignment to interventions ( for example, participants, care providers, those assessing outcomes) and how
如果实施了盲法,应说明对谁设盲(如研究对象、干预提供者、结局评价者),如何实施的
 
11bIf relevant, description of the similarity of interventions
组间干预的相似性
 
Statistical methods统计方法12aStatistical methods used to compare groups for primary and secondary outcomes
组间比较,主要结局与次要结局的统计方法
How clustering was taken into account
群是如何被考虑在内的
12bMethods for additional analyses, such as subgroup analyses and adjusted analyses
其他分析方法,如亚组分析和校正分析
 
Results
结果
Participant flow (a diagram is strongly recommended)
研究对象纳入流程(推荐流程图)
13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome
各组接受随机分配、接受干预和进入主要结局分析的研究对象数量
For each group, the numbers of clusters that were randomly assigned,received intended treatment, and were analyzed for the primary outcome
各组接受随机分配、接受干预和进入主要结局分析的群数量
13bFor each group, losses and exclusions after randomization,together with reasons
各组随机化之后发生的脱落或失访、排除,以及原因
For each group, losses and exclusions for both clusters and individual cluster members
随机分组后,各组发生失访、排除的群数和群内研究对象的例数
Recruitment
研究对象的招募
14aDates defining the periods of recruitment and follow-up
招募研究对象和随访的日期范围
 
14bWhy the trial ended or was stopped
研究结束或停止的原因
 
Baseline data
基线数据
15A table showing baseline demographic and clinical characteristics for each group
反映各组基线人口学特征和临床特征的表格
Baseline characteristics for the individual and cluster levels as applicable for each group
各组个体和群水平的基线特征
Number analyzed
分析数量
16For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups
各组纳入分析的研究对象数量(分母),是否按照最初分组进行分析
For each group, number of clusters included in each analysis
各组纳入分析的群数量
Outcomes and estimation
结局和效应估计
17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
对每个主要和次要结局,报告各组结果、效应估计和精度(如95%置信区间)
Results at the individual or cluster level as applicable and a coefficient of intracluster correlation (ICC or k) for each primary outcome
各组个体或群水平的结果,各主要结局的群内相关系数(ICC或k)
17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommended
对二分类结局,报告绝对效应和相对效应
 
Ancillary analyses
其他分析
18Results of any other analyses performed, including subgroup analyses and adjusted analyses,distinguishing prespecified from exploratory
报告其他分析(包括亚组分析和校正分析)结果,区分预先设定的分析和探索性分析
 
Harms
危害
19All important harms or unintended effects in each group
所有重要损害或未预期到的效应
 
Discussion
讨论
Limitations
局限性
20Trial limitations; addressing sources of potential bias; imprecision; and, if relevant, multiplicity of analyses
试验局限性;关注偏倚的来源;不精确程度;多重比较问题
 
Generalizability外推性21Generalizability (external validity, applicability) of the trial findings
试验结果的外推性(外部有效性、适用性)
Generalizability to clusters and/or individual participants(as relevant)
结果向群和/或个体的可推广性(视情况而定)
Interpretation
结果解释
22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
权衡收益和损害,并考虑其他相关证据,对结果进行解释
 
Other information
其他信息
Registration
注册
23Registration number and name of trial registry
注册机构与注册号
 
Protocol
研究方案
24Where the full trial protocol can be accessed, if available
可以获得完整研究方案的地方 (如适用)
 
Funding
资助
25Sources of funding and other support(such as supply of drugs), role of funders
资助来源和其他支持,资助者的作用
 

(二) 整群随机对照试验CONSORT扩展版摘要条目清单

2 整群随机对照试验CONSORT扩展版摘要条目清单的中英文对照

内容条目标准清单内容群设计的扩展内容
Title
题目
Identification of study as randomised
可通过标题判断为随机试验
Identification of study as cluster randomised
可通过标题判断为整群随机试验
Trial design
试验设计
Description of the trial design (for example, parallel, cluster, non-inferiority)
试验设计描述(如平行对照、整设计、非劣效性研究)
See Table 2
见表2
Methods
方法
Participants
研究对象
Eligibility criteria for participants and the settings where the data were collected
研究对象的纳入排除标准和资料的收集
Eligibility criteria for clusters
群组的纳入标准
Interventions
干预
Interventions intended for each group
针对每组的干预措施
 
Objective
目的
Specific objective or hypothesis
具体目的或假设
Whether objective or hypothesis pertains to the cluster level, the individual participant level, or both
目的或假设属于群组水平、个体水平还是两者皆有
Outcome
结局指标
Clearly defined primary outcome for this report
明确定义研究的主要结局指标
Whether the primary outcome pertains to the cluster level, the individual participant level or both
主要结局指标属于群组水平、个体水平还是两者皆有
Randomisation
随机化
How participants were allocated to interventions
如何对研究对象分配干预措施
How clusters were allocated to interventions
如何对群组分配干预措施
Blinding (masking)盲法Whether or not participants, care givers, and those assessing the outcomes were blinded to group assignment
研究对象、护理人员和结局评估者是否对分组不知情
 
Results
结果
Numbers randomised
数量随机化
Number of participants randomised to each group
随机分配到每组的受试者数量
Number of clusters randomised to each group
随机分配到每组的群组数量
Recruitment
招募
Trial status1
研究状态
 
Numbers analysed
数据分析
Number of participants analysed in each group
每组分析的受试者数量
Number of clusters analysed in each group
每组分析的受试群组数量
Outcome
结果
For the primary outcome, a result for each group and the estimated effect size and its precision
各组每一项主要结局和次要结局指标的结果,效应估计值及其精确性
Results at the cluster or individual level as applicable for each primary outcome
适用于每个主要结局指标的群组水平或个体水平的结果
Harms
不良反应
Important adverse events or side effects
重大不良事件或副作用
 
Conclusions
结论
General interpretation of the results
对结果的总体解释
 
Trial registration研究注册Registration number and name of trial register
临床试验注册号和注册机构名称
 
Funding资助Source of funding资金来源 
1 Relevant to conference abstracts.与会议摘要有关

(三) 整群随机对照试验CONSORT声明报告流程图

图1 整群随机对照试验CONSORT声明流程图(英文)
图2 整群随机对照试验CONSORT声明流程图(中文)

三、整群随机对照试验CONSORT扩展版使用注意事项

整群随机对照试验在设计时,为了更好地了解此类试验设计、实施和分析中的注意事项,建议参考整群随机对照试验CONSORT扩展版;投稿时,根据需要或要求可将整群随机对照试验CONSORT扩展版清单(checklist)作为投稿材料之一递交,并引用已发表的相关报告规范文献。审稿人也可根据编辑部要求参照整群随机对照试验CONSORT扩展版标准和作者提供的清单来审稿。一般CONSORT声明的注意事项和局限性同样适用于本扩展版声明。

注:本文内容是参考相关文献后对PRCT CONSORT扩展版报告规范原文的概述,仅代表本网站观点。关于整群随机对照试验CONSORT扩展版的更多内容详见官方网站(http://www.consort-statement.org)或论文Consort 2010 statement: extension to cluster randomised trials (https://www.bmj.com/content/345/bmj.e5661)。

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