\documentclass[10pt,letterpaper]{article} % Packages \usepackage[margin=0.5in]{geometry} \usepackage[utf8]{inputenc} \usepackage[T1]{fontenc} \usepackage{helvet} \renewcommand{\familydefault}{\sfdefault} \usepackage{xcolor} \usepackage{tcolorbox} \usepackage{array} \usepackage{tabularx} \usepackage{booktabs} \usepackage{enumitem} \usepackage{titlesec} \usepackage{fancyhdr} \usepackage{multicol} \usepackage{graphicx} \usepackage{float} % Color definitions \definecolor{headerblue}{RGB}{0,102,204} \definecolor{highlightgreen}{RGB}{0,153,76} \definecolor{warningred}{RGB}{204,0,0} \definecolor{highlightgray}{RGB}{240,240,240} \definecolor{biomarkerblue}{RGB}{51,102,204} % Section formatting - compact \titleformat{\section}{\normalfont\fontsize{11}{12}\bfseries\color{headerblue}}{\thesection}{0.5em}{} \titlespacing*{\section}{0pt}{4pt}{2pt} \titleformat{\subsection}{\normalfont\fontsize{10}{11}\bfseries}{\thesubsection}{0.5em}{} \titlespacing*{\subsection}{0pt}{3pt}{1pt} % List formatting - ultra compact \setlist[itemize]{leftmargin=*,itemsep=0pt,parsep=0pt,topsep=1pt} \setlist[enumerate]{leftmargin=*,itemsep=0pt,parsep=0pt,topsep=1pt} % Remove paragraph indentation \setlength{\parindent}{0pt} \setlength{\parskip}{2pt} % Header/footer \pagestyle{fancy} \fancyhf{} \fancyhead[L]{\footnotesize \textbf{Clinical Decision Support: [COHORT NAME]}} \fancyhead[R]{\footnotesize Page \thepage} \renewcommand{\headrulewidth}{0.5pt} \fancyfoot[C]{\footnotesize Confidential Medical Document - For Professional Use Only} \begin{document} % Title block - compact \begin{center} {\fontsize{14}{16}\selectfont\bfseries\color{headerblue} PATIENT COHORT ANALYSIS REPORT}\\[2pt] {\fontsize{12}{14}\selectfont\bfseries [Cohort Description - e.g., NSCLC Patients Stratified by PD-L1 Expression]}\\[2pt] {\fontsize{10}{12}\selectfont [Institution/Study Name]}\\[1pt] {\fontsize{9}{11}\selectfont Report Date: [Date]} \end{center} \vspace{4pt} % Executive Summary Box \begin{tcolorbox}[colback=highlightgray,colframe=headerblue,title=\textbf{Executive Summary},fonttitle=\bfseries\small,coltitle=black] {\small \textbf{Cohort}: [n=XX] patients with [disease] stratified by [biomarker/characteristic] \textbf{Key Findings}: \begin{itemize} \item [Primary finding - e.g., Biomarker+ patients had significantly longer PFS] \item [Secondary finding - e.g., ORR 45\% vs 30\%, p=0.023] \item [Safety finding - e.g., Similar toxicity profiles between groups] \end{itemize} \textbf{Clinical Implications}: [Treatment recommendations based on findings] } \end{tcolorbox} \vspace{2pt} \section{Cohort Characteristics} \subsection{Patient Demographics} [Narrative description of cohort composition, inclusion/exclusion criteria, time period] \begin{table}[H] \centering \small \begin{tabular}{lccc} \toprule \textbf{Characteristic} & \textbf{Group A (n=XX)} & \textbf{Group B (n=XX)} & \textbf{p-value} \\ \midrule Age, years (median [IQR]) & XX [XX-XX] & XX [XX-XX] & X.XX \\ Sex, n (\%) & & & \\ \quad Male & XX (XX\%) & XX (XX\%) & X.XX \\ \quad Female & XX (XX\%) & XX (XX\%) & \\ ECOG PS, n (\%) & & & \\ \quad 0-1 & XX (XX\%) & XX (XX\%) & X.XX \\ \quad 2 & XX (XX\%) & XX (XX\%) & \\ Disease Stage, n (\%) & & & \\ \quad III & XX (XX\%) & XX (XX\%) & X.XX \\ \quad IV & XX (XX\%) & XX (XX\%) & \\ Prior Lines of Therapy & & & \\ \quad 0 (treatment-naïve) & XX (XX\%) & XX (XX\%) & X.XX \\ \quad 1-2 & XX (XX\%) & XX (XX\%) & \\ \quad $\geq$3 & XX (XX\%) & XX (XX\%) & \\ \bottomrule \end{tabular} \caption{Baseline patient demographics and clinical characteristics} \end{table} \subsection{Biomarker Profile} \begin{tcolorbox}[colback=biomarkerblue!10,colframe=biomarkerblue,title=\textbf{Biomarker Stratification},fonttitle=\bfseries\small] {\small \textbf{Classification Method}: [e.g., IHC for PD-L1 expression, NGS for mutations, gene expression clustering] \textbf{Group Definitions}: \begin{itemize} \item \textbf{Group A (Biomarker+)}: [n=XX] - [Definition, e.g., PD-L1 TPS $\geq$50\%, or Mesenchymal-Immune-Active subtype] \item \textbf{Group B (Biomarker-)}: [n=XX] - [Definition, e.g., PD-L1 TPS <50\%] \end{itemize} \textbf{Molecular Features of Group A}: \begin{itemize} \item [Feature 1]: XX\% (n=XX) - [Clinical significance] \item [Feature 2]: XX\% (n=XX) - [Clinical significance] \item [Feature 3]: Elevated/decreased [marker] (median [value]) \end{itemize} } \end{tcolorbox} \section{Treatment Exposures} \begin{table}[H] \centering \small \begin{tabular}{lcc} \toprule \textbf{Treatment Received} & \textbf{Group A, n (\%)} & \textbf{Group B, n (\%)} \\ \midrule [Treatment regimen 1] & XX (XX\%) & XX (XX\%) \\ [Treatment regimen 2] & XX (XX\%) & XX (XX\%) \\ [Treatment regimen 3] & XX (XX\%) & XX (XX\%) \\ Median cycles received (range) & X (X-X) & X (X-X) \\ \bottomrule \end{tabular} \caption{Treatment exposures by biomarker group} \end{table} \section{Treatment Outcomes} \subsection{Response Rates} \begin{table}[H] \centering \small \begin{tabular}{lccc} \toprule \textbf{Response Category} & \textbf{Group A (n=XX)} & \textbf{Group B (n=XX)} & \textbf{p-value} \\ \midrule Objective Response Rate (ORR) & XX\% [95\% CI] & XX\% [95\% CI] & X.XXX \\ \quad Complete Response (CR) & XX (XX\%) & XX (XX\%) & \\ \quad Partial Response (PR) & XX (XX\%) & XX (XX\%) & \\ Disease Control Rate (DCR) & XX\% [95\% CI] & XX\% [95\% CI] & X.XXX \\ \quad Stable Disease (SD) & XX (XX\%) & XX (XX\%) & \\ Progressive Disease (PD) & XX (XX\%) & XX (XX\%) & \\ \midrule Median Duration of Response (months) & X.X (95\% CI X.X-X.X) & X.X (95\% CI X.X-X.X) & X.XXX \\ \bottomrule \end{tabular} \caption{Best overall response by biomarker group (RECIST v1.1 criteria)} \end{table} \subsection{Survival Outcomes} \textbf{Progression-Free Survival (PFS)}: \begin{itemize} \item Group A: Median X.X months (95\% CI X.X-X.X), 12-month PFS rate: XX\% \item Group B: Median X.X months (95\% CI X.X-X.X), 12-month PFS rate: XX\% \item Hazard Ratio: X.XX (95\% CI X.XX-X.XX), log-rank p = X.XXX \item \textit{[Interpretation: Group A had XX\% reduction in risk of progression compared to Group B]} \end{itemize} \textbf{Overall Survival (OS)}: \begin{itemize} \item Group A: Median XX.X months (95\% CI XX.X-XX.X), 12-month OS rate: XX\% \item Group B: Median XX.X months (95\% CI XX.X-XX.X), 12-month OS rate: XX\% \item Hazard Ratio: X.XX (95\% CI X.XX-X.XX), log-rank p = X.XXX \item \textit{[Interpretation: XX\% reduction in risk of death for Group A]} \end{itemize} % Note: Include Kaplan-Meier curves as figures if available % \begin{figure}[H] % \centering % \includegraphics[width=0.9\textwidth]{figures/pfs_by_biomarker.pdf} % \caption{Progression-free survival by biomarker status} % \end{figure} \section{Safety and Tolerability} \begin{table}[H] \centering \small \begin{tabular}{lcccc} \toprule \multirow{2}{*}{\textbf{Adverse Event}} & \multicolumn{2}{c}{\textbf{Any Grade, n (\%)}} & \multicolumn{2}{c}{\textbf{Grade 3-4, n (\%)}} \\ \cmidrule(lr){2-3} \cmidrule(lr){4-5} & Group A & Group B & Group A & Group B \\ \midrule [AE 1 - e.g., Fatigue] & XX (XX\%) & XX (XX\%) & X (X\%) & X (X\%) \\ [AE 2 - e.g., Nausea] & XX (XX\%) & XX (XX\%) & X (X\%) & X (X\%) \\ [AE 3 - e.g., Neutropenia] & XX (XX\%) & XX (XX\%) & X (X\%) & X (X\%) \\ [AE 4 - e.g., Diarrhea] & XX (XX\%) & XX (XX\%) & X (X\%) & X (X\%) \\ [AE 5 - immune-related] & XX (XX\%) & XX (XX\%) & X (X\%) & X (X\%) \\ \midrule Treatment discontinuation & XX (XX\%) & XX (XX\%) & \multicolumn{2}{c}{-} \\ Dose reductions & XX (XX\%) & XX (XX\%) & \multicolumn{2}{c}{-} \\ \bottomrule \end{tabular} \caption{Treatment-emergent adverse events by biomarker group (CTCAE v5.0)} \end{table} \section{Statistical Analysis} \subsection{Methods} \textbf{Study Design}: [Retrospective cohort analysis / Prospective cohort / Post-hoc analysis of clinical trial] \textbf{Statistical Tests}: \begin{itemize} \item Continuous variables: [t-test / Mann-Whitney U test], reported as [mean $\pm$ SD / median [IQR]] \item Categorical variables: Chi-square test or Fisher's exact test (if expected count <5) \item Survival analysis: Kaplan-Meier method, log-rank test, Cox proportional hazards regression \item Significance level: Two-sided p<0.05 considered statistically significant \item Software: [R version X.X.X, survival package / SAS / Stata / Python lifelines] \end{itemize} \subsection{Multivariable Analysis} Cox regression model adjusting for baseline prognostic factors: \begin{table}[H] \centering \small \begin{tabular}{lccc} \toprule \textbf{Variable} & \textbf{Hazard Ratio} & \textbf{95\% CI} & \textbf{p-value} \\ \midrule Biomarker+ (vs Biomarker-) & X.XX & X.XX-X.XX & X.XXX \\ Age (per 10 years) & X.XX & X.XX-X.XX & X.XXX \\ ECOG PS 2 (vs 0-1) & X.XX & X.XX-X.XX & X.XXX \\ Stage IV (vs III) & X.XX & X.XX-X.XX & X.XXX \\ [Additional variable] & X.XX & X.XX-X.XX & X.XXX \\ \bottomrule \end{tabular} \caption{Multivariable Cox regression for progression-free survival} \end{table} \textbf{Interpretation}: After adjusting for age, performance status, and disease stage, [biomarker status] remained an independent predictor of [PFS/OS] (HR X.XX, 95\% CI X.XX-X.XX, p=X.XXX). \section{Clinical Implications} \begin{tcolorbox}[colback=highlightgreen!10,colframe=highlightgreen,title=\textbf{Treatment Recommendations},fonttitle=\bfseries\small] {\small \textbf{For Biomarker-Positive Patients (Group A)}: \textbf{Preferred Regimen} (GRADE 1A): \begin{itemize} \item [Specific treatment based on biomarker] \item Evidence: [Trial name/data showing benefit in biomarker+ population] \item Expected outcomes: ORR XX\%, median PFS XX months \end{itemize} \textbf{Monitoring}: \begin{itemize} \item Imaging every [X weeks] for response assessment \item [Specific lab monitoring for biomarker+ patients] \item Watch for [specific toxicities more common in this group] \end{itemize} \textbf{For Biomarker-Negative Patients (Group B)}: \textbf{Standard Regimen} (GRADE 1B): \begin{itemize} \item [Standard therapy for biomarker- population] \item Expected outcomes: ORR XX\%, median PFS XX months \item Consider [alternative approaches or clinical trial enrollment] \end{itemize} } \end{tcolorbox} \section{Subgroup Analyses} \textbf{Interaction Testing}: Treatment effect by biomarker subgroup (p-interaction = X.XXX) [Describe whether treatment benefit differs by biomarker status - i.e., predictive biomarker] Additional exploratory subgroups: \begin{itemize} \item Age <65 vs $\geq$65 years \item Sex (male vs female) \item Prior lines of therapy (0 vs 1+ prior treatments) \item Disease burden (high vs low tumor burden) \end{itemize} \section{Strengths and Limitations} \subsection{Strengths} \begin{itemize} \item [e.g., Biomarker-stratified analysis with prospectively defined groups] \item [e.g., Adequate sample size for statistical power] \item [e.g., Standardized response assessment using RECIST v1.1] \item [e.g., Multivariable analysis adjusting for confounders] \end{itemize} \subsection{Limitations} \begin{itemize} \item [e.g., Retrospective design with potential selection bias] \item [e.g., Single-institution cohort may limit generalizability] \item [e.g., Biomarker testing not available for all patients (XX\% tested)] \item [e.g., Limited follow-up for OS (median X months)] \item [e.g., Heterogeneous treatment regimens across cohort] \end{itemize} \section{Conclusions} [Paragraph summarizing key findings] [Biomarker-positive patients demonstrated [significantly better/worse] outcomes compared to biomarker-negative patients, with [outcome metric] of [values] (HR X.XX, p=X.XXX). These findings support [biomarker-guided therapy selection / routine biomarker testing / specific treatment approach].] [Future directions: Prospective validation in independent cohort, investigation of mechanisms, clinical trial design implications] \section{References} \begin{enumerate} \item [Reference 1 - Key clinical trial] \item [Reference 2 - Biomarker validation study] \item [Reference 3 - Guideline reference (NCCN, ASCO, ESMO)] \item [Reference 4 - Statistical methods reference] \item [Reference 5 - Additional supporting evidence] \end{enumerate} \vspace{10pt} \hrule \vspace{4pt} {\footnotesize \textbf{Report Prepared By}: [Name, Title]\\ \textbf{Date}: [Date]\\ \textbf{Contact}: [Email/Phone]\\ \textbf{Institutional Review}: [IRB approval number if applicable]\\ \textbf{Data Cut-Off Date}: [Date]\\ \textbf{Confidentiality}: This document contains proprietary clinical data. Distribution restricted to authorized personnel only. } \end{document}