clinical-decision-support
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ChineseClinical 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:
- Patient Cohort Analysis - Biomarker-stratified group analyses with statistical outcome comparisons
- 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 skill instead. This skill focuses on group-level analyses and evidence synthesis for pharmaceutical/research settings.
treatment-plans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:
- 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
- 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。
treatment-plansCapabilities
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 skill)
treatment-plans - Bedside clinical care documentation (use skill)
treatment-plans - Simple patient-specific treatment protocols (use skill)
treatment-plans
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(使用技能)
treatment-plans - 床旁临床护理文档(使用技能)
treatment-plans - 简单的患者特定治疗方案(使用技能)
treatment-plans
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:
- Generate at minimum ONE schematic or diagram (e.g., clinical decision algorithm, treatment pathway, or biomarker stratification tree)
- For cohort analyses: include patient flow diagram
- 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.pngThe 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:
- 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)
- 队列分析:包含患者流程图
- 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.pngAI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):
-
Document Title and Type
- Main title (e.g., "Biomarker-Stratified Cohort Analysis" or "Evidence-Based Treatment Recommendations")
- Subtitle with disease state and focus
-
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
-
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 to remove page numbers from page 1
\thispagestyle{empty} - 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 before table of contents or detailed sections
\newpage
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):
-
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
-
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
-
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:
- 使用移除第1页的页码
\thispagestyle{empty} - 所有内容必须适配第1页(在之前)
\newpage - 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,之后再添加目录或详细章节
\newpage
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 3Patient 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:
- Report Information Box: Disease state, guideline version/date, target population
- Key Recommendations Box (green): Top 3-5 GRADE-graded recommendations by line of therapy
- Biomarker Decision Criteria Box (blue): Key molecular markers influencing treatment selection
- Evidence Summary Box (gray): Major trials supporting recommendations (e.g., KEYNOTE-189, FLAURA)
- 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:
- 报告信息框:疾病状态、指南版本/日期、目标人群
- 核心推荐框(绿色):按治疗线排序的3-5项GRADE分级推荐
- 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
- 证据摘要框(灰色):支持推荐的主要试验(例如:KEYNOTE-189、FLAURA)
- 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
- Patient Selection Transparency: Clearly document inclusion/exclusion criteria, patient flow, and reasons for exclusions
- Biomarker Clarity: Specify assay methods, platforms (e.g., FoundationOne, Caris), cut-points, and validation status
- 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
- Outcome Definitions: Use standard criteria:
- Response: RECIST 1.1, iRECIST for immunotherapy
- Adverse events: CTCAE version 5.0
- Performance status: ECOG or Karnofsky
- 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
- Subgroup Analyses: Pre-specify subgroups; clearly label exploratory vs pre-planned analyses
- Data Completeness: Report missing data and how it was handled
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- 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)
- Biomarker-Guided Recommendations:
- Link specific biomarkers to therapy recommendations
- Specify testing methods and validated assays
- Include FDA/EMA approval status for companion diagnostics
- Clinical Actionability: Every recommendation should have clear implementation guidance
- Decision Algorithm Clarity: TikZ flowcharts should be unambiguous with clear yes/no decision points
- Special Populations: Address elderly, renal/hepatic impairment, pregnancy, drug interactions
- Monitoring Guidance: Specify safety labs, imaging, and frequency
- Update Frequency: Date recommendations and plan for periodic updates
- 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)
- 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)
- 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
- 临床可操作性:每项推荐需包含明确的实施指导
- 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
- 特殊人群:覆盖老年患者、肾/肝功能损害、妊娠、药物相互作用
- 监测指导:指定安全性实验室检查、影像学检查及频率
- 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
- 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 and end with
\thispagestyle{empty}\newpage - This is the single most important page - it should be scannable in 60 seconds
- De-identification: Remove all 18 HIPAA identifiers before document generation (Safe Harbor method)
- Regulatory Compliance: Include confidentiality notices for proprietary pharmaceutical data
- Publication-Ready Formatting: Use 0.5in margins, professional fonts, color-coded sections
- Reproducibility: Document all statistical methods to enable replication
- Conflict of Interest: Disclose pharmaceutical funding or relationships when applicable
- Visual Hierarchy: Use colored boxes consistently (blue=data, green=biomarkers, yellow/orange=recommendations, red=warnings)
- 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
- 使用并以
\thispagestyle{empty}结尾\newpage - 这是最重要的一页 - 应能在60秒内快速浏览获取核心信息
- 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)
- 合规性:为制药专有数据添加保密声明
- 可发表格式:使用0.5英寸边距、专业字体、彩色编码章节
- 可重复性:记录所有统计方法以支持重复分析
- 利益冲突:披露制药资助或相关关系(如适用)
- 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 directory for detailed guidance on:
references/- 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
请查看目录获取以下主题的详细指导:
references/- 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 directory for LaTeX templates:
assets/- - Biomarker-stratified patient cohort analysis with statistical comparisons
cohort_analysis_template.tex - - Evidence-based clinical practice guidelines with GRADE grading
treatment_recommendation_template.tex - - TikZ decision algorithm flowcharts for treatment sequencing
clinical_pathway_template.tex - - Molecular subtype classification and genomic profile reports
biomarker_report_template.tex - - Systematic evidence review and meta-analysis summaries
evidence_synthesis_template.tex
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
请查看目录获取LaTeX模板:
assets/- - 包含统计对比的生物标志物分层患者队列分析模板
cohort_analysis_template.tex - - 包含GRADE分级的循证临床实践指南模板
treatment_recommendation_template.tex - - 用于治疗线序的TikZ决策算法流程图模板
clinical_pathway_template.tex - - 分子亚型分类与基因组谱报告模板
biomarker_report_template.tex - - 系统性证据回顾与荟萃分析摘要模板
evidence_synthesis_template.tex
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 directory for analysis and visualization tools:
scripts/- - Kaplan-Meier curve generation with log-rank tests, hazard ratios, 95% CI
generate_survival_analysis.py - - Best response visualization for cohort analyses
create_waterfall_plot.py - - Subgroup analysis visualization with confidence intervals
create_forest_plot.py - - Demographics, biomarker frequency, and outcomes tables
create_cohort_tables.py - - TikZ flowchart generation for treatment algorithms
build_decision_tree.py - - Patient stratification algorithms by molecular subtype
biomarker_classifier.py - - Hazard ratios, Cox regression, log-rank tests, Fisher's exact
calculate_statistics.py - - Quality and compliance checks (HIPAA, statistical reporting standards)
validate_cds_document.py - - Automated GRADE assessment helper for treatment recommendations
grade_evidence.py
请查看目录获取分析与可视化工具:
scripts/- - 生成含log-rank检验、风险比、95%CI的Kaplan-Meier曲线
generate_survival_analysis.py - - 用于队列分析的最佳响应可视化
create_waterfall_plot.py - - 含置信区间的亚组分析可视化
create_forest_plot.py - - 生成人口统计学、生物标志物频率、结局表格
create_cohort_tables.py - - 生成用于治疗算法的TikZ流程图
build_decision_tree.py - - 按分子亚型划分的患者分层算法
biomarker_classifier.py - - 计算风险比、Cox回归、log-rank检验、Fisher精确检验
calculate_statistics.py - - 质量与合规性检查(HIPAA、统计报告标准)
validate_cds_document.py - - 用于治疗推荐的自动化GRADE评估辅助工具
grade_evidence.py