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 | 整群设计的扩展内容 |
| Title and abstract 标题与摘要 | 1a | Identification 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 |
| 1b | Structured 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 | 2a | Scientific 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 |
| 2b | Specific 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 | 3a | Description 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 |
| 3b | Important 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 | 4a | Eligibility 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 |
| 4b | Settings and locations where the data were collected 数据收集的机构和地点 | ||
| Interventions 干预 | 5 | The 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 | 6a | Completely 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 |
| 6b | Any 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 | 7a | How 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 |
| 7b | When 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 | 8a | Method used to generate the random allocation sequence 产生随机分配序列的方法 | |
| 8b | Type 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 | 9 | Mechanism 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 | 10 | Who 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 | 11a | If 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 | |
| 11b | If relevant, description of the similarity of interventions 组间干预的相似性 | ||
| Statistical methods统计方法 | 12a | Statistical 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 |
| 12b | Methods 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) | 13a | For 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 |
| 13b | For 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 | 14a | Dates defining the periods of recruitment and follow-up 招募研究对象和随访的日期范围 | |
| 14b | Why the trial ended or was stopped 研究结束或停止的原因 | ||
| Baseline data 基线数据 | 15 | A 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 | 16 | For 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 | 17a | For 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) |
| 17b | For 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 | 18 | Results 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 | 19 | All 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 | 20 | Trial 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 | 21 | Generalizability (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 | 22 | Interpretation 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 | 23 | Registration number and name of trial registry 注册机构与注册号 | |
| Protocol 研究方案 | 24 | Where 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 | 25 | Sources 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
表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
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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