clinical-decision-support

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Clinical Decision Support Documents

临床决策支持(CDS)文档

Description

功能描述

Generate professional clinical decision support (CDS) documents for pharmaceutical companies, clinical researchers, and medical decision-makers. This skill specializes in analytical, evidence-based documents that inform treatment strategies and drug development:
  1. Patient Cohort Analysis - Biomarker-stratified group analyses with statistical outcome comparisons
  2. Treatment Recommendation Reports - Evidence-based clinical guidelines with GRADE grading and decision algorithms
All documents are generated as publication-ready LaTeX/PDF files optimized for pharmaceutical research, regulatory submissions, and clinical guideline development.
Note: For individual patient treatment plans at the bedside, use the
treatment-plans
skill instead. This skill focuses on group-level analyses and evidence synthesis for pharmaceutical/research settings.
为制药企业、临床研究人员和医疗决策者生成专业的临床决策支持(CDS)文档。本技能专注于生成分析性、循证性文档,为治疗策略和药物研发提供依据:
  1. 患者队列分析 - 基于生物标志物分层的组群分析,结合统计结局对比
  2. 治疗推荐报告 - 包含GRADE分级与决策算法的循证临床指南
所有文档均以可直接用于发表的LaTeX/PDF格式生成,专为药物研发、监管申报和临床指南制定优化。
注意:如需为床旁个体患者制定治疗方案,请使用
treatment-plans
技能。本技能专注于面向制药/研究场景的群体层面分析与证据合成。

Capabilities

核心能力

Document Types

文档类型

Patient Cohort Analysis
  • Biomarker-based patient stratification (molecular subtypes, gene expression, IHC)
  • Molecular subtype classification (e.g., GBM mesenchymal-immune-active vs proneural, breast cancer subtypes)
  • Outcome metrics with statistical analysis (OS, PFS, ORR, DOR, DCR)
  • Statistical comparisons between subgroups (hazard ratios, p-values, 95% CI)
  • Survival analysis with Kaplan-Meier curves and log-rank tests
  • Efficacy tables and waterfall plots
  • Comparative effectiveness analyses
  • Pharmaceutical cohort reporting (trial subgroups, real-world evidence)
Treatment Recommendation Reports
  • Evidence-based treatment guidelines for specific disease states
  • Strength of recommendation grading (GRADE system: 1A, 1B, 2A, 2B, 2C)
  • Quality of evidence assessment (high, moderate, low, very low)
  • Treatment algorithm flowcharts with TikZ diagrams
  • Line-of-therapy sequencing based on biomarkers
  • Decision pathways with clinical and molecular criteria
  • Pharmaceutical strategy documents
  • Clinical guideline development for medical societies
患者队列分析
  • 基于生物标志物的患者分层(分子亚型、基因表达、免疫组化(IHC))
  • 分子亚型分类(例如:胶质母细胞瘤(GBM)间质-免疫激活型vs前神经元型、乳腺癌亚型)
  • 结合统计分析的结局指标(OS、PFS、ORR、DOR、DCR)
  • 亚组间统计对比(风险比、p值、95%置信区间(CI))
  • 采用Kaplan-Meier曲线与log-rank检验的生存分析
  • 疗效表格与瀑布图
  • 对比有效性分析
  • 制药领域队列报告(试验亚组、真实世界证据)
治疗推荐报告
  • 针对特定疾病状态的循证治疗指南
  • 推荐强度分级(GRADE系统:1A、1B、2A、2B、2C)
  • 证据质量评估(高、中、低、极低)
  • 采用TikZ图的治疗算法流程图
  • 基于生物标志物的治疗线序
  • 结合临床与分子标准的决策路径
  • 制药策略文档
  • 为医学协会制定临床指南

Clinical Features

临床特性

  • Biomarker Integration: Genomic alterations (mutations, CNV, fusions), gene expression signatures, IHC markers, PD-L1 scoring
  • Statistical Analysis: Hazard ratios, p-values, confidence intervals, survival curves, Cox regression, log-rank tests
  • Evidence Grading: GRADE system (1A/1B/2A/2B/2C), Oxford CEBM levels, quality of evidence assessment
  • Clinical Terminology: SNOMED-CT, LOINC, proper medical nomenclature, trial nomenclature
  • Regulatory Compliance: HIPAA de-identification, confidentiality headers, ICH-GCP alignment
  • Professional Formatting: Compact 0.5in margins, color-coded recommendations, publication-ready, suitable for regulatory submissions
  • 生物标志物整合:基因组改变(突变、拷贝数变异(CNV)、融合)、基因表达特征、IHC标志物、PD-L1评分
  • 统计分析:风险比、p值、置信区间、生存曲线、Cox回归、log-rank检验
  • 证据分级:GRADE系统(1A/1B/2A/2B/2C)、牛津CEBM证据水平、证据质量评估
  • 临床术语:SNOMED-CT、LOINC、规范医学术语、试验命名规范
  • 合规性:HIPAA去标识化、保密页眉、ICH-GCP对齐
  • 专业格式:0.5英寸窄边距、彩色编码推荐、可直接用于发表、适用于监管申报

Pharmaceutical and Research Use Cases

制药与研究场景应用

This skill is specifically designed for pharmaceutical and clinical research applications:
Drug Development
  • Phase 2/3 Trial Analyses: Biomarker-stratified efficacy and safety analyses
  • Subgroup Analyses: Forest plots showing treatment effects across patient subgroups
  • Companion Diagnostic Development: Linking biomarkers to drug response
  • Regulatory Submissions: IND/NDA documentation with evidence summaries
Medical Affairs
  • KOL Education Materials: Evidence-based treatment algorithms for thought leaders
  • Medical Strategy Documents: Competitive landscape and positioning strategies
  • Advisory Board Materials: Cohort analyses and treatment recommendation frameworks
  • Publication Planning: Manuscript-ready analyses for peer-reviewed journals
Clinical Guidelines
  • Guideline Development: Evidence synthesis with GRADE methodology for specialty societies
  • Consensus Recommendations: Multi-stakeholder treatment algorithm development
  • Practice Standards: Biomarker-based treatment selection criteria
  • Quality Measures: Evidence-based performance metrics
Real-World Evidence
  • RWE Cohort Studies: Retrospective analyses of patient cohorts from EMR data
  • Comparative Effectiveness: Head-to-head treatment comparisons in real-world settings
  • Outcomes Research: Long-term survival and safety in clinical practice
  • Health Economics: Cost-effectiveness analyses by biomarker subgroup
本技能专为制药与临床研究场景设计:
药物研发
  • 2/3期试验分析:基于生物标志物分层的有效性与安全性分析
  • 亚组分析:展示各患者亚组治疗效果的森林图
  • 伴随诊断研发:关联生物标志物与药物响应
  • 监管申报:包含证据摘要的IND/NDA文档
医学事务
  • KOL教育材料:为意见领袖准备的循证治疗算法
  • 医学策略文档:竞争格局与定位策略
  • 顾问委员会材料:队列分析与治疗推荐框架
  • 发表规划:可直接用于同行评审期刊的手稿级分析
临床指南
  • 指南制定:采用GRADE方法学为专科协会进行证据合成
  • 共识推荐:多利益相关方参与的治疗算法开发
  • 实践标准:基于生物标志物的治疗选择标准
  • 质量指标:基于循证的绩效指标
真实世界证据
  • RWE队列研究:基于电子病历(EMR)数据的回顾性患者队列分析
  • 对比有效性:真实世界场景下的头对头治疗对比
  • 结局研究:临床实践中的长期生存与安全性
  • 卫生经济学:按生物标志物亚组划分的成本-效果分析

When to Use

使用场景

Use this skill when you need to:
  • Analyze patient cohorts stratified by biomarkers, molecular subtypes, or clinical characteristics
  • Generate treatment recommendation reports with evidence grading for clinical guidelines or pharmaceutical strategies
  • Compare outcomes between patient subgroups with statistical analysis (survival, response rates, hazard ratios)
  • Produce pharmaceutical research documents for drug development, clinical trials, or regulatory submissions
  • Develop clinical practice guidelines with GRADE evidence grading and decision algorithms
  • Document biomarker-guided therapy selection at the population level (not individual patients)
  • Synthesize evidence from multiple trials or real-world data sources
  • Create clinical decision algorithms with flowcharts for treatment sequencing
Do NOT use this skill for:
  • Individual patient treatment plans (use
    treatment-plans
    skill)
  • Bedside clinical care documentation (use
    treatment-plans
    skill)
  • Simple patient-specific treatment protocols (use
    treatment-plans
    skill)
当您需要以下服务时,使用本技能:
  • 分析患者队列:按生物标志物、分子亚型或临床特征分层
  • 生成治疗推荐报告:包含用于临床指南或制药策略的证据分级
  • 对比亚组结局:结合统计分析(生存、响应率、风险比)
  • 生成制药研究文档:用于药物研发、临床试验或监管申报
  • 制定临床实践指南:结合GRADE证据分级与决策算法
  • 记录群体层面的生物标志物导向治疗选择(非个体患者)
  • 合成多试验或真实世界数据源的证据
  • 创建包含流程图的临床决策算法用于治疗线序
请勿使用本技能进行以下操作
  • 制定个体患者治疗方案(使用
    treatment-plans
    技能)
  • 床旁临床护理文档(使用
    treatment-plans
    技能)
  • 简单的患者特定治疗方案(使用
    treatment-plans
    技能)

Visual Enhancement with Scientific Schematics

科学示意图可视化增强

⚠️ MANDATORY: Every clinical decision support document MUST include at least 1-2 AI-generated figures using the scientific-schematics skill.
This is not optional. Clinical decision documents require clear visual algorithms. Before finalizing any document:
  1. Generate at minimum ONE schematic or diagram (e.g., clinical decision algorithm, treatment pathway, or biomarker stratification tree)
  2. For cohort analyses: include patient flow diagram
  3. For treatment recommendations: include decision flowchart
How to generate figures:
  • Use the scientific-schematics skill to generate AI-powered publication-quality diagrams
  • Simply describe your desired diagram in natural language
  • Nano Banana Pro will automatically generate, review, and refine the schematic
How to generate schematics:
bash
python scripts/generate_schematic.py "your diagram description" -o figures/output.png
The AI will automatically:
  • Create publication-quality images with proper formatting
  • Review and refine through multiple iterations
  • Ensure accessibility (colorblind-friendly, high contrast)
  • Save outputs in the figures/ directory
When to add schematics:
  • Clinical decision algorithm flowcharts
  • Treatment pathway diagrams
  • Biomarker stratification trees
  • Patient cohort flow diagrams (CONSORT-style)
  • Survival curve visualizations
  • Molecular mechanism diagrams
  • Any complex concept that benefits from visualization
For detailed guidance on creating schematics, refer to the scientific-schematics skill documentation.

⚠️ 强制要求:每份临床决策支持文档必须包含至少1-2张使用scientific-schematics技能生成的AI示意图。
此要求为强制性。临床决策文档需清晰的可视化算法。在最终确定任何文档前:
  1. 至少生成一张示意图或图表(例如:临床决策算法、治疗路径或生物标志物分层树)
  2. 队列分析:包含患者流程图
  3. 治疗推荐:包含决策流程图
如何生成示意图
  • 使用scientific-schematics技能生成AI驱动的可发表级图表
  • 只需用自然语言描述您所需的图表
  • Nano Banana Pro将自动生成、审核并优化示意图
示意图生成命令
bash
python scripts/generate_schematic.py "your diagram description" -o figures/output.png
AI将自动:
  • 创建格式规范的可发表级图像
  • 通过多轮迭代审核与优化
  • 确保可访问性(色盲友好、高对比度)
  • 将输出保存至figures/目录
何时添加示意图
  • 临床决策算法流程图
  • 治疗路径图
  • 生物标志物分层树
  • 患者队列流程图(CONSORT风格)
  • 生存曲线可视化
  • 分子机制图
  • 任何需可视化的复杂概念
有关创建示意图的详细指南,请参考scientific-schematics技能文档。

Document Structure

文档结构

CRITICAL REQUIREMENT: All clinical decision support documents MUST begin with a complete executive summary on page 1 that spans the entire first page before any table of contents or detailed sections.
关键要求:所有临床决策支持文档必须在第1页包含完整的执行摘要,占据整个第1页,之后再添加目录或详细章节。

Page 1 Executive Summary Structure

第1页执行摘要结构

The first page of every CDS document should contain ONLY the executive summary with the following components:
Required Elements (all on page 1):
  1. Document Title and Type
    • Main title (e.g., "Biomarker-Stratified Cohort Analysis" or "Evidence-Based Treatment Recommendations")
    • Subtitle with disease state and focus
  2. Report Information Box (using colored tcolorbox)
    • Document type and purpose
    • Date of analysis/report
    • Disease state and patient population
    • Author/institution (if applicable)
    • Analysis framework or methodology
  3. Key Findings Boxes (3-5 colored boxes using tcolorbox)
    • Primary Results (blue box): Main efficacy/outcome findings
    • Biomarker Insights (green box): Key molecular subtype findings
    • Clinical Implications (yellow/orange box): Actionable treatment implications
    • Statistical Summary (gray box): Hazard ratios, p-values, key statistics
    • Safety Highlights (red box, if applicable): Critical adverse events or warnings
Visual Requirements:
  • Use
    \thispagestyle{empty}
    to remove page numbers from page 1
  • All content must fit on page 1 (before
    \newpage
    )
  • Use colored tcolorbox environments with different colors for visual hierarchy
  • Boxes should be scannable and highlight most critical information
  • Use bullet points, not narrative paragraphs
  • End page 1 with
    \newpage
    before table of contents or detailed sections
Example First Page LaTeX Structure:
latex
\maketitle
\thispagestyle{empty}

% Report Information Box
\begin{tcolorbox}[colback=blue!5!white, colframe=blue!75!black, title=Report Information]
\textbf{Document Type:} Patient Cohort Analysis\\
\textbf{Disease State:} HER2-Positive Metastatic Breast Cancer\\
\textbf{Analysis Date:} \today\\
\textbf{Population:} 60 patients, biomarker-stratified by HR status
\end{tcolorbox}

\vspace{0.3cm}

% Key Finding #1: Primary Results
\begin{tcolorbox}[colback=blue!5!white, colframe=blue!75!black, title=Primary Efficacy Results]
\begin{itemize}
    \item Overall ORR: 72\% (95\% CI: 59-83\%)
    \item Median PFS: 18.5 months (95\% CI: 14.2-22.8)
    \item Median OS: 35.2 months (95\% CI: 28.1-NR)
\end{itemize}
\end{tcolorbox}

\vspace{0.3cm}

% Key Finding #2: Biomarker Insights
\begin{tcolorbox}[colback=green!5!white, colframe=green!75!black, title=Biomarker Stratification Findings]
\begin{itemize}
    \item HR+/HER2+: ORR 68\%, median PFS 16.2 months
    \item HR-/HER2+: ORR 78\%, median PFS 22.1 months
    \item HR status significantly associated with outcomes (p=0.041)
\end{itemize}
\end{tcolorbox}

\vspace{0.3cm}

% Key Finding #3: Clinical Implications
\begin{tcolorbox}[colback=orange!5!white, colframe=orange!75!black, title=Clinical Recommendations]
\begin{itemize}
    \item Strong efficacy observed regardless of HR status (Grade 1A)
    \item HR-/HER2+ patients showed numerically superior outcomes
    \item Treatment recommended for all HER2+ MBC patients
\end{itemize}
\end{tcolorbox}

\newpage
\tableofcontents  % TOC on page 2
\newpage  % Detailed content starts page 3
每份CDS文档的第1页应仅包含执行摘要,且需包含以下组件:
必填要素(全部位于第1页)
  1. 文档标题与类型
    • 主标题(例如:“生物标志物分层队列分析”或“循证治疗推荐”)
    • 包含疾病状态与核心焦点的副标题
  2. 报告信息框(使用彩色tcolorbox)
    • 文档类型与目的
    • 分析/报告日期
    • 疾病状态与患者人群
    • 作者/机构(如适用)
    • 分析框架或方法学
  3. 关键发现框(3-5个彩色tcolorbox)
    • 主要结果(蓝色框):核心疗效/结局发现
    • 生物标志物洞察(绿色框):关键分子亚型发现
    • 临床意义(黄/橙色框):可执行的治疗意义
    • 统计摘要(灰色框):风险比、p值、关键统计数据
    • 安全重点(红色框,如适用):严重不良事件或警告
可视化要求
  • 使用
    \thispagestyle{empty}
    移除第1页的页码
  • 所有内容必须适配第1页(在
    \newpage
    之前)
  • 使用彩色tcolorbox环境,通过不同颜色区分层级
  • 框体应便于快速扫描,突出最关键信息
  • 使用项目符号,而非叙述性段落
  • 第1页末尾添加
    \newpage
    ,之后再添加目录或详细章节
第1页LaTeX结构示例
latex
\maketitle
\thispagestyle{empty}

% Report Information Box
\begin{tcolorbox}[colback=blue!5!white, colframe=blue!75!black, title=Report Information]
\textbf{Document Type:} Patient Cohort Analysis\\
\textbf{Disease State:} HER2-Positive Metastatic Breast Cancer\\
\textbf{Analysis Date:} \today\\
\textbf{Population:} 60 patients, biomarker-stratified by HR status
\end{tcolorbox}

\vspace{0.3cm}

% Key Finding #1: Primary Results
\begin{tcolorbox}[colback=blue!5!white, colframe=blue!75!black, title=Primary Efficacy Results]
\begin{itemize}
    \item Overall ORR: 72\% (95\% CI: 59-83\%)
    \item Median PFS: 18.5 months (95\% CI: 14.2-22.8)
    \item Median OS: 35.2 months (95\% CI: 28.1-NR)
\end{itemize}
\end{tcolorbox}

\vspace{0.3cm}

% Key Finding #2: Biomarker Insights
\begin{tcolorbox}[colback=green!5!white, colframe=green!75!black, title=Biomarker Stratification Findings]
\begin{itemize}
    \item HR+/HER2+: ORR 68\%, median PFS 16.2 months
    \item HR-/HER2+: ORR 78\%, median PFS 22.1 months
    \item HR status significantly associated with outcomes (p=0.041)
\end{itemize}
\end{tcolorbox}

\vspace{0.3cm}

% Key Finding #3: Clinical Implications
\begin{tcolorbox}[colback=orange!5!white, colframe=orange!75!black, title=Clinical Recommendations]
\begin{itemize}
    \item Strong efficacy observed regardless of HR status (Grade 1A)
    \item HR-/HER2+ patients showed numerically superior outcomes
    \item Treatment recommended for all HER2+ MBC patients
\end{itemize}
\end{tcolorbox}

\newpage
\tableofcontents  % TOC on page 2
\newpage  % Detailed content starts page 3

Patient Cohort Analysis (Detailed Sections - Page 3+)

患者队列分析(详细章节 - 第3页及以后)

  • Cohort Characteristics: Demographics, baseline features, patient selection criteria
  • Biomarker Stratification: Molecular subtypes, genomic alterations, IHC profiles
  • Treatment Exposure: Therapies received, dosing, treatment duration by subgroup
  • Outcome Analysis: Response rates (ORR, DCR), survival data (OS, PFS), DOR
  • Statistical Methods: Kaplan-Meier survival curves, hazard ratios, log-rank tests, Cox regression
  • Subgroup Comparisons: Biomarker-stratified efficacy, forest plots, statistical significance
  • Safety Profile: Adverse events by subgroup, dose modifications, discontinuations
  • Clinical Recommendations: Treatment implications based on biomarker profiles
  • Figures: Waterfall plots, swimmer plots, survival curves, forest plots
  • Tables: Demographics table, biomarker frequency, outcomes by subgroup
  • 队列特征:人口统计学特征、基线特征、患者入选标准
  • 生物标志物分层:分子亚型、基因组改变、IHC谱
  • 治疗暴露:各亚组接受的治疗、剂量、治疗时长
  • 结局分析:响应率(ORR、DCR)、生存数据(OS、PFS)、DOR
  • 统计方法:Kaplan-Meier生存曲线、风险比、log-rank检验、Cox回归
  • 亚组对比:基于生物标志物分层的疗效、森林图、统计显著性
  • 安全性特征:各亚组的不良事件、剂量调整、停药情况
  • 临床推荐:基于生物标志物谱的治疗意义
  • 图表:瀑布图、游泳图、生存曲线、森林图
  • 表格:人口统计学表格、生物标志物频率、各亚组结局

Treatment Recommendation Reports (Detailed Sections - Page 3+)

治疗推荐报告(详细章节 - 第3页及以后)

Page 1 Executive Summary for Treatment Recommendations should include:
  1. Report Information Box: Disease state, guideline version/date, target population
  2. Key Recommendations Box (green): Top 3-5 GRADE-graded recommendations by line of therapy
  3. Biomarker Decision Criteria Box (blue): Key molecular markers influencing treatment selection
  4. Evidence Summary Box (gray): Major trials supporting recommendations (e.g., KEYNOTE-189, FLAURA)
  5. Critical Monitoring Box (orange/red): Essential safety monitoring requirements
Detailed Sections (Page 3+):
  • Clinical Context: Disease state, epidemiology, current treatment landscape
  • Target Population: Patient characteristics, biomarker criteria, staging
  • Evidence Review: Systematic literature synthesis, guideline summary, trial data
  • Treatment Options: Available therapies with mechanism of action
  • Evidence Grading: GRADE assessment for each recommendation (1A, 1B, 2A, 2B, 2C)
  • Recommendations by Line: First-line, second-line, subsequent therapies
  • Biomarker-Guided Selection: Decision criteria based on molecular profiles
  • Treatment Algorithms: TikZ flowcharts showing decision pathways
  • Monitoring Protocol: Safety assessments, efficacy monitoring, dose modifications
  • Special Populations: Elderly, renal/hepatic impairment, comorbidities
  • References: Full bibliography with trial names and citations
治疗推荐报告的第1页执行摘要应包含
  1. 报告信息框:疾病状态、指南版本/日期、目标人群
  2. 核心推荐框(绿色):按治疗线排序的3-5项GRADE分级推荐
  3. 生物标志物决策标准框(蓝色):影响治疗选择的关键分子标志物
  4. 证据摘要框(灰色):支持推荐的主要试验(例如:KEYNOTE-189、FLAURA)
  5. 关键监测框(橙/红色):必要的安全性监测要求
详细章节(第3页及以后)
  • 临床背景:疾病状态、流行病学、当前治疗格局
  • 目标人群:患者特征、生物标志物标准、分期
  • 证据回顾:系统性文献合成、指南摘要、试验数据
  • 治疗选项:可用疗法及其作用机制
  • 证据分级:每项推荐的GRADE评估(1A、1B、2A、2B、2C)
  • 按治疗线推荐:一线、二线、后续治疗
  • 生物标志物导向选择:基于分子谱的决策标准
  • 治疗算法:展示决策路径的TikZ流程图
  • 监测方案:安全性实验室检查、影像学检查及频率
  • 特殊人群:老年患者、肾/肝功能损害、妊娠、药物相互作用
  • 参考文献:包含试验名称与引用的完整文献目录

Output Format

输出格式

MANDATORY FIRST PAGE REQUIREMENT:
  • Page 1: Full-page executive summary with 3-5 colored tcolorbox elements
  • Page 2: Table of contents (optional)
  • Page 3+: Detailed sections with methods, results, figures, tables
Document Specifications:
  • Primary: LaTeX/PDF with 0.5in margins for compact, data-dense presentation
  • Length: Typically 5-15 pages (1 page executive summary + 4-14 pages detailed content)
  • Style: Publication-ready, pharmaceutical-grade, suitable for regulatory submissions
  • First Page: Always a complete executive summary spanning entire page 1 (see Document Structure section)
Visual Elements:
  • Colors:
    • Page 1 boxes: blue=data/information, green=biomarkers/recommendations, yellow/orange=clinical implications, red=warnings
    • Recommendation boxes (green=strong recommendation, yellow=conditional, blue=research needed)
    • Biomarker stratification (color-coded molecular subtypes)
    • Statistical significance (color-coded p-values, hazard ratios)
  • Tables:
    • Demographics with baseline characteristics
    • Biomarker frequency by subgroup
    • Outcomes table (ORR, PFS, OS, DOR by molecular subtype)
    • Adverse events by cohort
    • Evidence summary tables with GRADE ratings
  • Figures:
    • Kaplan-Meier survival curves with log-rank p-values and number at risk tables
    • Waterfall plots showing best response by patient
    • Forest plots for subgroup analyses with confidence intervals
    • TikZ decision algorithm flowcharts
    • Swimmer plots for individual patient timelines
  • Statistics: Hazard ratios with 95% CI, p-values, median survival times, landmark survival rates
  • Compliance: De-identification per HIPAA Safe Harbor, confidentiality notices for proprietary data
强制第1页要求
  • 第1页:完整的执行摘要,包含3-5个彩色tcolorbox
  • 第2页:目录(可选)
  • 第3页及以后:包含方法、结果、图表、表格的详细章节
文档规格
  • 主要格式:LaTeX/PDF,采用0.5英寸窄边距以实现紧凑、高密度数据展示
  • 篇幅:通常5-15页(1页执行摘要 + 4-14页详细内容)
  • 风格:可直接用于发表的制药级格式,适用于监管申报
  • 第1页:始终为占据整页的完整执行摘要(详见文档结构章节)
可视化要素
  • 颜色
    • 第1页框体:蓝色=数据/信息、绿色=生物标志物/推荐、黄/橙色=临床意义、红色=警告
    • 推荐框(绿色=强推荐、黄色=条件推荐、蓝色=需研究)
    • 生物标志物分层(按分子亚型颜色编码)
    • 统计显著性(按p值、风险比颜色编码)
  • 表格
    • 包含基线特征的人口统计学表格
    • 各亚组的生物标志物频率表格
    • 按分子亚型划分的结局表格(ORR、PFS、OS、DOR)
    • 各队列的不良事件表格
    • 包含GRADE评级的证据摘要表格
  • 图表
    • 包含log-rank p值与风险人数表格的Kaplan-Meier生存曲线
    • 展示患者最佳响应的瀑布图
    • 包含置信区间的亚组分析森林图
    • TikZ决策算法流程图
    • 展示个体患者时间线的游泳图
  • 统计数据:包含95%CI的风险比、p值、中位生存时间、Landmark生存率
  • 合规性:按HIPAA安全港标准去标识化、专有数据保密声明

Integration

集成能力

This skill integrates with:
  • scientific-writing: Citation management, statistical reporting, evidence synthesis
  • clinical-reports: Medical terminology, HIPAA compliance, regulatory documentation
  • scientific-schematics: TikZ flowcharts for decision algorithms and treatment pathways
  • treatment-plans: Individual patient applications of cohort-derived insights (bidirectional)
本技能可与以下技能集成:
  • scientific-writing:引用管理、统计报告、证据合成
  • clinical-reports:医学术语、HIPAA合规、监管文档
  • scientific-schematics:用于决策算法与治疗路径的TikZ流程图
  • treatment-plans:队列衍生洞见在个体患者中的应用(双向集成)

Key Differentiators from Treatment-Plans Skill

与Treatment-Plans技能的核心差异

Clinical Decision Support (this skill):
  • Audience: Pharmaceutical companies, clinical researchers, guideline committees, medical affairs
  • Scope: Population-level analyses, evidence synthesis, guideline development
  • Focus: Biomarker stratification, statistical comparisons, evidence grading
  • Output: Multi-page analytical documents (5-15 pages typical) with extensive figures and tables
  • Use Cases: Drug development, regulatory submissions, clinical practice guidelines, medical strategy
  • Example: "Analyze 60 HER2+ breast cancer patients by hormone receptor status with survival outcomes"
Treatment-Plans Skill:
  • Audience: Clinicians, patients, care teams
  • Scope: Individual patient care planning
  • Focus: SMART goals, patient-specific interventions, monitoring plans
  • Output: Concise 1-4 page actionable care plans
  • Use Cases: Bedside clinical care, EMR documentation, patient-centered planning
  • Example: "Create treatment plan for a 55-year-old patient with newly diagnosed type 2 diabetes"
When to use each:
  • Use clinical-decision-support for: cohort analyses, biomarker stratification studies, treatment guideline development, pharmaceutical strategy documents
  • Use treatment-plans for: individual patient care plans, treatment protocols for specific patients, bedside clinical documentation
临床决策支持(本技能)
  • 受众:制药企业、临床研究人员、指南委员会、医学事务部门
  • 范围:群体层面分析、证据合成、指南制定
  • 焦点:生物标志物分层、统计对比、证据分级
  • 输出:多页分析性文档(通常5-15页),包含大量图表
  • 应用场景:药物研发、监管申报、临床实践指南、医学策略
  • 示例:“分析60例HER2+乳腺癌患者按激素受体状态分层的生存结局”
Treatment-Plans技能
  • 受众:临床医生、患者、护理团队
  • 范围:个体患者护理规划
  • 焦点:SMART目标、患者特定干预、监测计划
  • 输出:简洁的1-4页可执行护理计划
  • 应用场景:床旁临床护理、EMR文档、以患者为中心的规划
  • 示例:“为55岁新诊断2型糖尿病患者制定治疗计划”
如何选择
  • 使用clinical-decision-support:队列分析、生物标志物分层研究、治疗指南制定、制药策略文档
  • 使用treatment-plans:个体患者护理计划、特定患者治疗方案、床旁临床文档

Example Usage

使用示例

Patient Cohort Analysis

患者队列分析

Example 1: NSCLC Biomarker Stratification
> Analyze a cohort of 45 NSCLC patients stratified by PD-L1 expression (<1%, 1-49%, ≥50%) 
> receiving pembrolizumab. Include outcomes: ORR, median PFS, median OS with hazard ratios 
> comparing PD-L1 ≥50% vs <50%. Generate Kaplan-Meier curves and waterfall plot.
Example 2: GBM Molecular Subtype Analysis
> Generate cohort analysis for 30 GBM patients classified into Cluster 1 (Mesenchymal-Immune-Active) 
> and Cluster 2 (Proneural) molecular subtypes. Compare outcomes including median OS, 6-month PFS rate, 
> and response to TMZ+bevacizumab. Include biomarker profile table and statistical comparison.
Example 3: Breast Cancer HER2 Cohort
> Analyze 60 HER2-positive metastatic breast cancer patients treated with trastuzumab-deruxtecan, 
> stratified by prior trastuzumab exposure (yes/no). Include ORR, DOR, median PFS with forest plot 
> showing subgroup analyses by hormone receptor status, brain metastases, and number of prior lines.
示例1:NSCLC生物标志物分层
> Analyze a cohort of 45 NSCLC patients stratified by PD-L1 expression (<1%, 1-49%, ≥50%) 
> receiving pembrolizumab. Include outcomes: ORR, median PFS, median OS with hazard ratios 
> comparing PD-L1 ≥50% vs <50%. Generate Kaplan-Meier curves and waterfall plot.
示例2:GBM分子亚型分析
> Generate cohort analysis for 30 GBM patients classified into Cluster 1 (Mesenchymal-Immune-Active) 
> and Cluster 2 (Proneural) molecular subtypes. Compare outcomes including median OS, 6-month PFS rate, 
> and response to TMZ+bevacizumab. Include biomarker profile table and statistical comparison.
示例3:乳腺癌HER2队列
> Analyze 60 HER2-positive metastatic breast cancer patients treated with trastuzumab-deruxtecan, 
> stratified by prior trastuzumab exposure (yes/no). Include ORR, DOR, median PFS with forest plot 
> showing subgroup analyses by hormone receptor status, brain metastases, and number of prior lines.

Treatment Recommendation Report

治疗推荐报告

Example 1: HER2+ Metastatic Breast Cancer Guidelines
> Create evidence-based treatment recommendations for HER2-positive metastatic breast cancer including 
> biomarker-guided therapy selection. Use GRADE system to grade recommendations for first-line 
> (trastuzumab+pertuzumab+taxane), second-line (trastuzumab-deruxtecan), and third-line options. 
> Include decision algorithm flowchart based on brain metastases, hormone receptor status, and prior therapies.
Example 2: Advanced NSCLC Treatment Algorithm
> Generate treatment recommendation report for advanced NSCLC based on PD-L1 expression, EGFR mutation, 
> ALK rearrangement, and performance status. Include GRADE-graded recommendations for each molecular subtype, 
> TikZ flowchart for biomarker-directed therapy selection, and evidence tables from KEYNOTE-189, FLAURA, 
> and CheckMate-227 trials.
Example 3: Multiple Myeloma Line-of-Therapy Sequencing
> Create treatment algorithm for newly diagnosed multiple myeloma through relapsed/refractory setting. 
> Include GRADE recommendations for transplant-eligible vs ineligible, high-risk cytogenetics considerations, 
> and sequencing of daratumumab, carfilzomib, and CAR-T therapy. Provide flowchart showing decision points 
> at each line of therapy.
示例1:HER2+转移性乳腺癌指南
> Create evidence-based treatment recommendations for HER2-positive metastatic breast cancer including 
> biomarker-guided therapy selection. Use GRADE system to grade recommendations for first-line 
> (trastuzumab+pertuzumab+taxane), second-line (trastuzumab-deruxtecan), and third-line options. 
> Include decision algorithm flowchart based on brain metastases, hormone receptor status, and prior therapies.
示例2:晚期NSCLC治疗算法
> Generate treatment recommendation report for advanced NSCLC based on PD-L1 expression, EGFR mutation, 
> ALK rearrangement, and performance status. Include GRADE-graded recommendations for each molecular subtype, 
> TikZ flowchart for biomarker-directed therapy selection, and evidence tables from KEYNOTE-189, FLAURA, 
> and CheckMate-227 trials.
示例3:多发性骨髓瘤治疗线序
> Create treatment algorithm for newly diagnosed multiple myeloma through relapsed/refractory setting. 
> Include GRADE recommendations for transplant-eligible vs ineligible, high-risk cytogenetics considerations, 
> and sequencing of daratumumab, carfilzomib, and CAR-T therapy. Provide flowchart showing decision points 
> at each line of therapy.

Key Features

核心特性

Biomarker Classification

生物标志物分类

  • Genomic: Mutations, CNV, gene fusions
  • Expression: RNA-seq, IHC scores
  • Molecular subtypes: Disease-specific classifications
  • Clinical actionability: Therapy selection guidance
  • 基因组层面:突变、CNV、基因融合
  • 表达层面:RNA-seq、IHC评分
  • 分子亚型:疾病特异性分类
  • 临床可操作性:治疗选择指导

Outcome Metrics

结局指标

  • Survival: OS (overall survival), PFS (progression-free survival)
  • Response: ORR (objective response rate), DOR (duration of response), DCR (disease control rate)
  • Quality: ECOG performance status, symptom burden
  • Safety: Adverse events, dose modifications
  • 生存指标:OS(总生存期)、PFS(无进展生存期)
  • 响应指标:ORR(客观缓解率)、DOR(缓解持续时间)、DCR(疾病控制率)
  • 质量指标:ECOG体能状态、症状负担
  • 安全指标:不良事件、剂量调整

Statistical Methods

统计方法

  • Survival analysis: Kaplan-Meier curves, log-rank tests
  • Group comparisons: t-tests, chi-square, Fisher's exact
  • Effect sizes: Hazard ratios, odds ratios with 95% CI
  • Significance: p-values, multiple testing corrections
  • 生存分析:Kaplan-Meier曲线、log-rank检验
  • 组群对比:t检验、卡方检验、Fisher精确检验
  • 效应量:风险比、优势比(含95%CI)
  • 显著性:p值、多重检验校正

Evidence Grading

证据分级

GRADE System
  • 1A: Strong recommendation, high-quality evidence
  • 1B: Strong recommendation, moderate-quality evidence
  • 2A: Weak recommendation, high-quality evidence
  • 2B: Weak recommendation, moderate-quality evidence
  • 2C: Weak recommendation, low-quality evidence
Recommendation Strength
  • Strong: Benefits clearly outweigh risks
  • Conditional: Trade-offs exist, patient values important
  • Research: Insufficient evidence, clinical trials needed
GRADE系统
  • 1A:强推荐,高质量证据
  • 1B:强推荐,中等质量证据
  • 2A:弱推荐,高质量证据
  • 2B:弱推荐,中等质量证据
  • 2C:弱推荐,低质量证据
推荐强度
  • 强推荐:获益明显大于风险
  • 条件推荐:存在权衡,患者价值观重要
  • 研究推荐:证据不足,需开展临床试验

Best Practices

最佳实践

For Cohort Analyses

队列分析最佳实践

  1. Patient Selection Transparency: Clearly document inclusion/exclusion criteria, patient flow, and reasons for exclusions
  2. Biomarker Clarity: Specify assay methods, platforms (e.g., FoundationOne, Caris), cut-points, and validation status
  3. Statistical Rigor:
    • Report hazard ratios with 95% confidence intervals, not just p-values
    • Include median follow-up time for survival analyses
    • Specify statistical tests used (log-rank, Cox regression, Fisher's exact)
    • Account for multiple comparisons when appropriate
  4. Outcome Definitions: Use standard criteria:
    • Response: RECIST 1.1, iRECIST for immunotherapy
    • Adverse events: CTCAE version 5.0
    • Performance status: ECOG or Karnofsky
  5. Survival Data Presentation:
    • Median OS/PFS with 95% CI
    • Landmark survival rates (6-month, 12-month, 24-month)
    • Number at risk tables below Kaplan-Meier curves
    • Censoring clearly indicated
  6. Subgroup Analyses: Pre-specify subgroups; clearly label exploratory vs pre-planned analyses
  7. Data Completeness: Report missing data and how it was handled
  1. 患者入选透明性:明确记录入选/排除标准、患者流图及排除原因
  2. 生物标志物清晰度:指定检测方法、平台(例如:FoundationOne、Caris)、临界值及验证状态
  3. 统计严谨性
    • 报告含95%CI的风险比,而非仅p值
    • 生存分析需报告中位随访时间
    • 指定所用统计检验方法(log-rank、Cox回归、Fisher精确检验)
    • 适当时考虑多重检验校正
  4. 结局定义:采用标准标准:
    • 响应:RECIST 1.1、免疫治疗用iRECIST
    • 不良事件:CTCAE 5.0版
    • 体能状态:ECOG或Karnofsky评分
  5. 生存数据呈现
    • 含95%CI的中位OS/PFS
    • Landmark生存率(6个月、12个月、24个月)
    • Kaplan-Meier曲线下方的风险人数表格
    • 明确标注截尾数据
  6. 亚组分析:预先指定亚组;明确标注探索性vs预先规划的分析
  7. 数据完整性:报告缺失数据及处理方式

For Treatment Recommendation Reports

治疗推荐报告最佳实践

  1. Evidence Grading Transparency:
    • Use GRADE system consistently (1A, 1B, 2A, 2B, 2C)
    • Document rationale for each grade
    • Clearly state quality of evidence (high, moderate, low, very low)
  2. Comprehensive Evidence Review:
    • Include phase 3 randomized trials as primary evidence
    • Supplement with phase 2 data for emerging therapies
    • Note real-world evidence and meta-analyses
    • Cite trial names (e.g., KEYNOTE-189, CheckMate-227)
  3. Biomarker-Guided Recommendations:
    • Link specific biomarkers to therapy recommendations
    • Specify testing methods and validated assays
    • Include FDA/EMA approval status for companion diagnostics
  4. Clinical Actionability: Every recommendation should have clear implementation guidance
  5. Decision Algorithm Clarity: TikZ flowcharts should be unambiguous with clear yes/no decision points
  6. Special Populations: Address elderly, renal/hepatic impairment, pregnancy, drug interactions
  7. Monitoring Guidance: Specify safety labs, imaging, and frequency
  8. Update Frequency: Date recommendations and plan for periodic updates
  1. 证据分级透明性
    • 一致使用GRADE系统(1A、1B、2A、2B、2C)
    • 记录每一级别的分级理由
    • 明确说明证据质量(高、中、低、极低)
  2. 全面证据回顾
    • 以3期随机试验作为主要证据
    • 补充新兴疗法的2期数据
    • 标注真实世界证据与荟萃分析
    • 引用试验名称(例如:KEYNOTE-189、CheckMate-227)
  3. 生物标志物导向推荐
    • 将特定生物标志物与治疗推荐关联
    • 指定检测方法与验证检测
    • 包含FDA/EMA批准的伴随诊断状态
  4. 临床可操作性:每项推荐需包含明确的实施指导
  5. 决策算法清晰度:TikZ流程图需明确无误,包含清晰的是/否决策点
  6. 特殊人群:覆盖老年患者、肾/肝功能损害、妊娠、药物相互作用
  7. 监测指导:指定安全性实验室检查、影像学检查及频率
  8. 更新频率:标注推荐日期,并规划定期更新

General Best Practices

通用最佳实践

  1. First Page Executive Summary (MANDATORY):
    • ALWAYS create a complete executive summary on page 1 that spans the entire first page
    • Use 3-5 colored tcolorbox elements to highlight key findings
    • No table of contents or detailed sections on page 1
    • Use
      \thispagestyle{empty}
      and end with
      \newpage
    • This is the single most important page - it should be scannable in 60 seconds
  2. De-identification: Remove all 18 HIPAA identifiers before document generation (Safe Harbor method)
  3. Regulatory Compliance: Include confidentiality notices for proprietary pharmaceutical data
  4. Publication-Ready Formatting: Use 0.5in margins, professional fonts, color-coded sections
  5. Reproducibility: Document all statistical methods to enable replication
  6. Conflict of Interest: Disclose pharmaceutical funding or relationships when applicable
  7. Visual Hierarchy: Use colored boxes consistently (blue=data, green=biomarkers, yellow/orange=recommendations, red=warnings)
  1. 第1页执行摘要(强制要求)
    • 始终在第1页创建占据整页的完整执行摘要
    • 使用3-5个彩色tcolorbox突出关键发现
    • 第1页不得包含目录或详细章节
    • 使用
      \thispagestyle{empty}
      并以
      \newpage
      结尾
    • 这是最重要的一页 - 应能在60秒内快速浏览获取核心信息
  2. 去标识化:在生成文档前移除所有18项HIPAA标识符(采用安全港方法)
  3. 合规性:为制药专有数据添加保密声明
  4. 可发表格式:使用0.5英寸边距、专业字体、彩色编码章节
  5. 可重复性:记录所有统计方法以支持重复分析
  6. 利益冲突:披露制药资助或相关关系(如适用)
  7. 可视化层级:一致使用彩色框(蓝色=数据、绿色=生物标志物、黄/橙色=推荐、红色=警告)

References

参考文献

See the
references/
directory for detailed guidance on:
  • Patient cohort analysis and stratification methods
  • Treatment recommendation development
  • Clinical decision algorithms
  • Biomarker classification and interpretation
  • Outcome analysis and statistical methods
  • Evidence synthesis and grading systems
请查看
references/
目录获取以下主题的详细指导:
  • 患者队列分析与分层方法
  • 治疗推荐制定
  • 临床决策算法
  • 生物标志物分类与解读
  • 结局分析与统计方法
  • 证据合成与分级系统

Templates

模板

See the
assets/
directory for LaTeX templates:
  • cohort_analysis_template.tex
    - Biomarker-stratified patient cohort analysis with statistical comparisons
  • treatment_recommendation_template.tex
    - Evidence-based clinical practice guidelines with GRADE grading
  • clinical_pathway_template.tex
    - TikZ decision algorithm flowcharts for treatment sequencing
  • biomarker_report_template.tex
    - Molecular subtype classification and genomic profile reports
  • evidence_synthesis_template.tex
    - Systematic evidence review and meta-analysis summaries
Template Features:
  • 0.5in margins for compact presentation
  • Color-coded recommendation boxes
  • Professional tables for demographics, biomarkers, outcomes
  • Built-in support for Kaplan-Meier curves, waterfall plots, forest plots
  • GRADE evidence grading tables
  • Confidentiality headers for pharmaceutical documents
请查看
assets/
目录获取LaTeX模板:
  • cohort_analysis_template.tex
    - 包含统计对比的生物标志物分层患者队列分析模板
  • treatment_recommendation_template.tex
    - 包含GRADE分级的循证临床实践指南模板
  • clinical_pathway_template.tex
    - 用于治疗线序的TikZ决策算法流程图模板
  • biomarker_report_template.tex
    - 分子亚型分类与基因组谱报告模板
  • evidence_synthesis_template.tex
    - 系统性证据回顾与荟萃分析摘要模板
模板特性
  • 0.5英寸边距以实现紧凑展示
  • 彩色编码推荐框
  • 用于人口统计学、生物标志物、结局的专业表格
  • 内置Kaplan-Meier曲线、瀑布图、森林图支持
  • GRADE证据分级表格
  • 制药文档专用保密页眉

Scripts

脚本

See the
scripts/
directory for analysis and visualization tools:
  • generate_survival_analysis.py
    - Kaplan-Meier curve generation with log-rank tests, hazard ratios, 95% CI
  • create_waterfall_plot.py
    - Best response visualization for cohort analyses
  • create_forest_plot.py
    - Subgroup analysis visualization with confidence intervals
  • create_cohort_tables.py
    - Demographics, biomarker frequency, and outcomes tables
  • build_decision_tree.py
    - TikZ flowchart generation for treatment algorithms
  • biomarker_classifier.py
    - Patient stratification algorithms by molecular subtype
  • calculate_statistics.py
    - Hazard ratios, Cox regression, log-rank tests, Fisher's exact
  • validate_cds_document.py
    - Quality and compliance checks (HIPAA, statistical reporting standards)
  • grade_evidence.py
    - Automated GRADE assessment helper for treatment recommendations
请查看
scripts/
目录获取分析与可视化工具:
  • generate_survival_analysis.py
    - 生成含log-rank检验、风险比、95%CI的Kaplan-Meier曲线
  • create_waterfall_plot.py
    - 用于队列分析的最佳响应可视化
  • create_forest_plot.py
    - 含置信区间的亚组分析可视化
  • create_cohort_tables.py
    - 生成人口统计学、生物标志物频率、结局表格
  • build_decision_tree.py
    - 生成用于治疗算法的TikZ流程图
  • biomarker_classifier.py
    - 按分子亚型划分的患者分层算法
  • calculate_statistics.py
    - 计算风险比、Cox回归、log-rank检验、Fisher精确检验
  • validate_cds_document.py
    - 质量与合规性检查(HIPAA、统计报告标准)
  • grade_evidence.py
    - 用于治疗推荐的自动化GRADE评估辅助工具