CONSORT 流程图¶

用途：展示临床试验受试者筛选、随机分配、随访和数据分析各阶段的流程图，是论文发表和监管提交的必备内容。

实现方式¶

CONSORT 流程图推荐使用 Mermaid（Markdown 原生支持）或 draw.io 绘制。

MermaidR

graph TD
    A["Assessed for eligibility (n=XXX)"] --> B["Excluded (n=XX)<br/>• Not meeting criteria (n=XX)<br/>• Declined (n=XX)<br/>• Other reasons (n=XX)"]
    A --> C["Randomized (n=XXX)"]
    C --> D["Allocated to Drug (n=XX)<br/>• Received (n=XX)<br/>• Not received (n=XX)"]
    C --> E["Allocated to Placebo (n=XX)<br/>• Received (n=XX)<br/>• Not received (n=XX)"]
    D --> F["Lost to follow-up (n=XX)<br/>Discontinued (n=XX)"]
    E --> G["Lost to follow-up (n=XX)<br/>Discontinued (n=XX)"]
    F --> H["Analyzed (n=XX)<br/>• Excluded (n=XX)"]
    G --> I["Analyzed (n=XX)<br/>• Excluded (n=XX)"]

library(DiagrammeR)

grViz("
  digraph consort {
    graph [layout = dot, rankdir = TB]
    node [shape = rectangle, style = filled, fillcolor = LightBlue]

    'Assessed (n=XXX)' -> 'Randomized (n=XXX)'
    'Assessed (n=XXX)' -> 'Excluded (n=XX)'
    'Randomized (n=XXX)' -> 'Drug (n=XX)'
    'Randomized (n=XXX)' -> 'Placebo (n=XX)'
    'Drug (n=XX)' -> 'Analyzed Drug (n=XX)'
    'Placebo (n=XX)' -> 'Analyzed Placebo (n=XX)'
  }
")

关键要点¶

遵循 CONSORT 2010 指南标准格式
每个阶段需报告具体数字
包括筛选 → 随机 → 分配 → 随访 → 分析五个阶段

参考方法¶

描述性统计