530 lines
18 KiB
TeX
530 lines
18 KiB
TeX
\documentclass[10pt,letterpaper]{article}
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% Packages
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\usepackage{graphicx}
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\usepackage{tikz}
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% Color definitions
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\definecolor{headerblue}{RGB}{0,102,204}
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\definecolor{stronggreen}{RGB}{0,153,76}
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\definecolor{conditionalyellow}{RGB}{255,193,7}
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\definecolor{researchblue}{RGB}{33,150,243}
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\definecolor{warningred}{RGB}{204,0,0}
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\definecolor{highlightgray}{RGB}{240,240,240}
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% Section formatting - compact
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\titleformat{\section}{\normalfont\fontsize{11}{12}\bfseries\color{headerblue}}{\thesection}{0.5em}{}
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\titleformat{\subsection}{\normalfont\fontsize{10}{11}\bfseries}{\thesubsection}{0.5em}{}
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% List formatting - ultra compact
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\setlist[itemize]{leftmargin=*,itemsep=0pt,parsep=0pt,topsep=1pt}
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\setlist[enumerate]{leftmargin=*,itemsep=0pt,parsep=0pt,topsep=1pt}
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% Remove paragraph indentation
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% Header/footer
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\pagestyle{fancy}
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\fancyhf{}
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\fancyhead[L]{\footnotesize \textbf{Treatment Recommendations: [CONDITION]}}
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\fancyhead[R]{\footnotesize Page \thepage}
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\renewcommand{\headrulewidth}{0.5pt}
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\fancyfoot[C]{\footnotesize Evidence-Based Clinical Guideline - For Professional Use Only}
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\begin{document}
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% Title block
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\begin{center}
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{\fontsize{14}{16}\selectfont\bfseries\color{headerblue} EVIDENCE-BASED TREATMENT RECOMMENDATIONS}\\[2pt]
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{\fontsize{12}{14}\selectfont\bfseries [Disease/Condition - e.g., HER2+ Metastatic Breast Cancer]}\\[2pt]
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{\fontsize{10}{12}\selectfont [Institution/Organization]}\\[1pt]
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{\fontsize{9}{11}\selectfont Version X.X | Effective Date: [Date] | Next Review: [Date]}
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\end{center}
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\vspace{4pt}
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% Recommendation Strength Legend
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\begin{tcolorbox}[colback=highlightgray,colframe=black,title=\textbf{Recommendation Strength Key},fonttitle=\bfseries\small,coltitle=black]
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{\small
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\begin{itemize}
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\item \colorbox{stronggreen!30}{\textbf{STRONG (Grade 1)}} - Benefits clearly outweigh risks; most patients should receive intervention
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\item \colorbox{conditionalyellow!30}{\textbf{CONDITIONAL (Grade 2)}} - Trade-offs exist; shared decision-making essential
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\item \colorbox{researchblue!30}{\textbf{RESEARCH (Grade R)}} - Insufficient evidence; clinical trial enrollment preferred
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\end{itemize}
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\textbf{Evidence Quality}: \textbf{A} = High (RCTs), \textbf{B} = Moderate (RCTs with limitations), \textbf{C} = Low (observational), \textbf{D} = Very low (expert opinion)
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}
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\end{tcolorbox}
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\vspace{2pt}
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\section{Clinical Context}
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\subsection{Disease Overview}
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[Brief description of disease state, epidemiology, natural history]
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\subsection{Patient Population}
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\textbf{Target Population}:
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\begin{itemize}
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\item [Demographic characteristics - e.g., Adults $\geq$18 years]
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\item [Disease stage/severity - e.g., Metastatic disease, Stage IV]
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\item [Biomarker status - e.g., HER2-positive (IHC 3+ or FISH+)]
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\item [Performance status - e.g., ECOG 0-2]
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\item [Line of therapy - e.g., First-line, previously untreated]
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\end{itemize}
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\textbf{Exclusions}:
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\begin{itemize}
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\item [Contraindications to recommended therapies]
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\item [Comorbidities affecting eligibility]
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\end{itemize}
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\section{Evidence Review}
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\subsection{Key Clinical Trials}
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\textbf{[Trial Name 1]} (Author, Journal Year):
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\begin{itemize}
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\item \textbf{Design}: Phase 3 RCT, n=XXX, [Treatment A] vs [Treatment B]
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\item \textbf{Population}: [Key eligibility criteria]
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\item \textbf{Primary Endpoint}: [Outcome] - XX vs XX months (HR X.XX, 95\% CI X.XX-X.XX, p<X.XXX)
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\item \textbf{Secondary Endpoints}: [Additional outcomes]
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\item \textbf{Safety}: Grade 3-4 AEs XX\% vs XX\%
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\item \textbf{Quality}: \textbf{High} (low risk of bias, adequate power, intention-to-treat analysis)
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\end{itemize}
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\textbf{[Trial Name 2]} (Author, Journal Year):
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\begin{itemize}
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\item \textbf{Design}: Phase 3 RCT, n=XXX, [Treatment C] vs [Standard of care]
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\item \textbf{Primary Endpoint}: [Outcome and results]
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\item \textbf{Quality}: \textbf{Moderate} (some limitations)
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\end{itemize}
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\subsection{Guideline Concordance}
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\begin{table}[H]
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\centering
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\small
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\begin{tabular}{lll}
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\toprule
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\textbf{Guideline} & \textbf{Recommendation} & \textbf{Evidence Level} \\
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\midrule
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NCCN vX.XXXX & [Specific recommendation] & Category 1 (preferred) \\
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ASCO Year & [Recommendation] & Strong, Evidence A \\
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ESMO Year & [Recommendation] & Grade I, A \\
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\bottomrule
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\end{tabular}
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\caption{Major guideline recommendations}
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\end{table}
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\section{Treatment Options}
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\subsection{First-Line Therapy}
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\begin{tcolorbox}[enhanced,colback=stronggreen!10,colframe=stronggreen,
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title={\textbf{Option 1: [Regimen Name]} \hfill \colorbox{white}{\textbf{STRONG (1A)}}},
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fonttitle=\bfseries\small,coltitle=black]
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{\small
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\textbf{Regimen}:
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\begin{itemize}
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\item [Drug A]: XX mg [IV/PO] [schedule]
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\item [Drug B]: XX mg [IV/PO] [schedule]
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\item Cycle length: XX days
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\item Duration: Until progression or unacceptable toxicity
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\end{itemize}
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\textbf{Evidence Basis}:
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\begin{itemize}
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\item Primary study: [Trial name], n=XXX
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\item Primary outcome: [Endpoint] XX vs XX months (HR X.XX, p<X.XXX)
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\item ORR: XX\% vs XX\% (control)
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\end{itemize}
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\textbf{Indications}:
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\begin{itemize}
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\item [Biomarker-defined population or all patients]
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\item [Performance status requirement]
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\item [Organ function requirements]
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\end{itemize}
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\textbf{Key Toxicities}:
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\begin{itemize}
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\item Grade 3-4 AEs: XX\%
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\item Common: [List 3-5 most common AEs with incidence]
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\item Serious: [SAEs, discontinuation rate]
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\item Management: [Key mitigation strategies]
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\end{itemize}
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\textbf{Monitoring}:
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\begin{itemize}
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\item Labs: [Specific tests, frequency]
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\item Imaging: Every [X weeks] (RECIST v1.1)
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\item Clinical assessment: Every cycle
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\end{itemize}
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\textbf{Recommendation Strength}: \textbf{STRONG} - Benefits clearly outweigh risks\\
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\textbf{Evidence Quality}: \textbf{HIGH} - Well-designed RCT with consistent results
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}
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\end{tcolorbox}
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\vspace{3pt}
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\begin{tcolorbox}[enhanced,colback=conditionalyellow!10,colframe=conditionalyellow,
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title={\textbf{Option 2: [Alternative Regimen]} \hfill \colorbox{white}{\textbf{CONDITIONAL (2B)}}},
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fonttitle=\bfseries\small,coltitle=black]
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{\small
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\textbf{Regimen}: [Dosing details]
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\textbf{Evidence Basis}: [Moderate-quality evidence or specific population subset]
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\textbf{Indications}: [When to consider this option - e.g., patient preference for oral therapy, specific contraindication to Option 1]
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\textbf{Trade-offs}:
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\begin{itemize}
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\item Advantages: [e.g., Oral administration, better tolerability]
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\item Disadvantages: [e.g., Lower response rate, less survival benefit]
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\end{itemize}
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\textbf{Recommendation Strength}: \textbf{CONDITIONAL} - Patient values important in decision\\
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\textbf{Evidence Quality}: \textbf{MODERATE} - Some limitations in evidence base
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}
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\end{tcolorbox}
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\vspace{3pt}
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\begin{tcolorbox}[enhanced,colback=researchblue!10,colframe=researchblue,
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title={\textbf{Option 3: Clinical Trial} \hfill \colorbox{white}{\textbf{RESEARCH (R)}}},
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fonttitle=\bfseries\small,coltitle=black]
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{\small
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\textbf{Recommendation}: Consider clinical trial enrollment for [specific scenario - e.g., biomarker-selected patients, refractory disease]
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\textbf{Available Trials}: [List relevant trials if known, or state "ClinicalTrials.gov search"]
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\textbf{Rationale}: [Why clinical trial appropriate - e.g., novel mechanism, unmet medical need, investigational biomarker]
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}
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\end{tcolorbox}
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\subsection{Second-Line and Beyond}
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\textbf{At Progression on First-Line Therapy}:
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\begin{itemize}
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\item \textbf{Biomarker Re-Testing}: [If applicable - e.g., liquid biopsy for resistance mutations]
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\item \textbf{Second-Line Options}:
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\begin{itemize}
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\item Preferred: [Regimen] (Evidence level)
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\item Alternative: [Regimen] (Evidence level)
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\end{itemize}
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\item \textbf{Third-Line Options}: [Subsequent therapy options]
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\end{itemize}
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\section{Special Populations}
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\subsection{Elderly Patients ($\geq$70 years)}
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\textbf{Considerations}:
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\begin{itemize}
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\item Geriatric assessment recommended (G8 screening tool)
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\item Dose reductions: [Specific adjustments for frail patients]
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\item Monitoring: More frequent assessments for toxicity
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\end{itemize}
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\textbf{Regimen Modifications}:
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\begin{itemize}
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\item [Reduced-intensity regimens if appropriate]
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\item [Single-agent vs combination considerations]
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\end{itemize}
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\subsection{Renal Impairment}
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\begin{table}[H]
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\centering
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\footnotesize
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\begin{tabular}{lll}
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\toprule
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\textbf{eGFR (mL/min/1.73m²)} & \textbf{Category} & \textbf{Dose Adjustment} \\
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\midrule
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$\geq$60 & Normal/Mild & Standard dosing \\
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30-59 & Moderate & [Specific adjustment - e.g., Reduce 25\%] \\
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15-29 & Severe & [Specific adjustment - e.g., Reduce 50\% or avoid] \\
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<15 or dialysis & ESRD & [Use with caution or contraindicated] \\
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\bottomrule
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\end{tabular}
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\caption{Dose adjustments for renal impairment}
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\end{table}
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\subsection{Hepatic Impairment}
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[Similar table for hepatic dose adjustments using Child-Pugh class or bilirubin/transaminases]
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\section{Clinical Decision Algorithm}
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% Simple flowchart example - can be expanded with more complex TikZ
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\begin{center}
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\begin{tikzpicture}[node distance=1.8cm, auto,
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decision/.style={diamond, draw, fill=conditionalyellow!30, text width=4.5em, text centered, inner sep=1pt, font=\tiny},
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process/.style={rectangle, draw, fill=stronggreen!20, text width=5.5em, text centered, rounded corners, minimum height=2em, font=\tiny},
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terminal/.style={rectangle, draw, fill=highlightgray, text width=5.5em, text centered, rounded corners=6pt, minimum height=2em, font=\tiny},
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alert/.style={rectangle, draw=warningred, line width=1pt, fill=warningred!10, text width=5.5em, text centered, rounded corners, minimum height=2em, font=\tiny\bfseries},
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arrow/.style={thick,->,>=stealth}]
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\node [terminal] (start) {[Disease] Diagnosis Confirmed};
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\node [decision, below of=start, node distance=1.8cm] (biomarker) {Biomarker\\ Positive?};
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\node [process, left of=biomarker, node distance=3.5cm] (optionA) {Targeted\\ Therapy};
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\node [process, right of=biomarker, node distance=3.5cm] (optionB) {Standard\\ Therapy};
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\node [terminal, below of=biomarker, node distance=2.5cm] (monitor) {Monitor Response\\ Every X weeks};
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\draw [arrow] (start) -- (biomarker);
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\draw [arrow] (biomarker) -- node[above] {Yes} (optionA);
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\draw [arrow] (biomarker) -- node[above] {No} (optionB);
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\draw [arrow] (optionA) |- (monitor);
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\draw [arrow] (optionB) |- (monitor);
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\end{tikzpicture}
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\end{center}
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{\footnotesize \textit{Figure 1: Simplified treatment selection algorithm. See detailed algorithm in references for complete decision pathway.}}
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\section{Monitoring Protocol}
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\subsection{On-Treatment Monitoring}
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\begin{table}[H]
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\centering
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\footnotesize
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\begin{tabular}{lccl}
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\toprule
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\textbf{Assessment} & \textbf{Baseline} & \textbf{Frequency} & \textbf{Rationale} \\
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\midrule
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CBC with differential & $\checkmark$ & Before each cycle & Myelosuppression \\
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Comprehensive metabolic panel & $\checkmark$ & Before each cycle & Organ function \\
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[Specific biomarker] & $\checkmark$ & Every X cycles & [Reason] \\
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Imaging (CT chest/abd/pelvis) & $\checkmark$ & Every X weeks & Response assessment \\
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ECOG performance status & $\checkmark$ & Every visit & Functional status \\
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Toxicity assessment (CTCAE) & - & Every visit & Safety monitoring \\
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\bottomrule
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\end{tabular}
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\caption{Recommended monitoring schedule}
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\end{table}
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\subsection{Dose Modification Guidelines}
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\textbf{Hematologic Toxicity}:
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\begin{itemize}
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\item \textbf{ANC <1.0 or Platelets <75k}: Delay treatment, recheck weekly, dose reduce 20\% when recovered
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\item \textbf{ANC <0.5 or Platelets <50k}: Hold treatment, G-CSF support, dose reduce 25-40\%
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\item \textbf{Febrile neutropenia}: Hold, hospitalize, antibiotics, dose reduce 25\% when recovered
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\end{itemize}
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\textbf{Non-Hematologic Toxicity}:
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\begin{itemize}
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\item \textbf{Grade 2}: Continue with supportive care, consider dose modification if persistent
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\item \textbf{Grade 3}: Hold until $\leq$Grade 1, resume at reduced dose (20-25\% reduction)
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\item \textbf{Grade 4}: Discontinue treatment or hold pending recovery (case-by-case)
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\end{itemize}
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\textbf{Specific Toxicity Management}:
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\begin{itemize}
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\item \textbf{[Specific AE]}: [Management approach - e.g., Diarrhea Grade 3: Hold treatment, loperamide, hydration, resume at reduced dose when $\leq$Grade 1]
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\item \textbf{[Immune-related AE]}: [Management - e.g., Pneumonitis Grade 2+: Hold immunotherapy, corticosteroids, pulmonology consultation]
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\end{itemize}
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\section{Treatment Recommendations by Clinical Scenario}
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\subsection{Scenario 1: [Specific Clinical Situation]}
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\begin{tcolorbox}[enhanced,colback=stronggreen!10,colframe=stronggreen,
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title={\textbf{RECOMMENDATION} \hfill \textbf{GRADE: 1A}},
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fonttitle=\bfseries\small,coltitle=black]
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{\small
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\textbf{We recommend} [specific intervention] for [patient population].
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\textbf{Evidence}:
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\begin{itemize}
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\item [Primary supporting evidence with results]
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\item [Guideline concordance - NCCN, ASCO, ESMO]
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\end{itemize}
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\textbf{Benefits}: [Quantified improvements - e.g., 8.7-month PFS benefit, HR 0.46]
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\textbf{Harms}: [Quantified risks - e.g., 15\% grade 3-4 immune-related AEs]
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\textbf{Balance}: Benefits clearly outweigh harms for most patients
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}
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\end{tcolorbox}
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\subsection{Scenario 2: [Alternative Clinical Situation]}
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\begin{tcolorbox}[enhanced,colback=conditionalyellow!10,colframe=conditionalyellow,
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title={\textbf{RECOMMENDATION} \hfill \textbf{GRADE: 2B}},
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fonttitle=\bfseries\small,coltitle=black]
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{\small
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\textbf{We suggest} [intervention] for [patient population] who value [specific outcome].
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\textbf{Evidence}: [Moderate-quality evidence summary]
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\textbf{Trade-offs}:
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\begin{itemize}
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\item \textbf{Advantages}: [e.g., Oral administration, less frequent monitoring]
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\item \textbf{Disadvantages}: [e.g., Lower response rate, more out-of-pocket cost]
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\end{itemize}
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\textbf{Patient Values}: Substantial variability in how patients value outcomes; shared decision-making essential
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}
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\end{tcolorbox}
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\section{Alternative Approaches}
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\subsection{Non-Recommended Options}
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\begin{tcolorbox}[enhanced,colback=warningred!10,colframe=warningred,
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title={\textbf{NOT RECOMMENDED}},
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fonttitle=\bfseries\small,coltitle=white,colbacktitle=warningred]
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{\small
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\textbf{[Intervention X]} is \textbf{not recommended} for [population].
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\textbf{Reason}: [Evidence of harm, lack of benefit, or superior alternatives available]
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\textbf{Evidence}: [Supporting data showing no benefit or harm]
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}
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\end{tcolorbox}
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\section{Supportive Care}
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\subsection{Symptom Management}
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\begin{itemize}
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\item \textbf{Pain Control}: [Analgesic recommendations, WHO ladder]
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\item \textbf{Nausea Prevention}: [Antiemetics - e.g., 5-HT3 antagonists, NK1 antagonists for highly emetogenic]
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\item \textbf{Bone Health}: [e.g., Bisphosphonates or denosumab if bone metastases]
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\item \textbf{Nutritional Support}: [Consult if weight loss >5\%, cachexia management]
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\item \textbf{Psychosocial Support}: [Depression screening, support groups, palliative care early integration]
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\end{itemize}
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\subsection{Growth Factor Support}
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\textbf{G-CSF Prophylaxis}:
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\begin{itemize}
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\item \textbf{Primary prophylaxis}: If febrile neutropenia risk $\geq$20\%
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\item \textbf{Secondary prophylaxis}: After prior febrile neutropenia episode
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\item Agent: [Pegfilgrastim 6 mg SC day 2 or filgrastim 5 mcg/kg SC daily days 3-10]
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\end{itemize}
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\section{Follow-Up and Surveillance}
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\subsection{During Active Treatment}
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[Schedule outlined in Monitoring Protocol section above]
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\subsection{Post-Treatment Surveillance}
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\begin{table}[H]
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\centering
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\footnotesize
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\begin{tabular}{lccc}
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\toprule
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\textbf{Time Period} & \textbf{Imaging} & \textbf{Labs} & \textbf{Clinical Visits} \\
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\midrule
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Year 1 & Every 3 months & Every 3 months & Every 3 months \\
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Year 2 & Every 3-4 months & Every 3-4 months & Every 3-4 months \\
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Years 3-5 & Every 6 months & Every 6 months & Every 6 months \\
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Year 5+ & Annually & Annually & Annually \\
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\bottomrule
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\end{tabular}
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\caption{Post-treatment surveillance schedule (adjust based on risk of recurrence)}
|
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\end{table}
|
|
|
|
\section{Clinical Trial Opportunities}
|
|
|
|
\textbf{When to Consider Clinical Trials}:
|
|
\begin{itemize}
|
|
\item After progression on standard therapies
|
|
\item High-risk disease with poor prognosis on standard therapy
|
|
\item Novel biomarker potentially predictive of response
|
|
\item Patient preference for investigational approach
|
|
\end{itemize}
|
|
|
|
\textbf{Resources}:
|
|
\begin{itemize}
|
|
\item ClinicalTrials.gov search: [Specific keywords]
|
|
\item [Institution] clinical trials office: [Contact information]
|
|
\end{itemize}
|
|
|
|
\section{Shared Decision-Making}
|
|
|
|
\subsection{Key Discussion Points}
|
|
|
|
\textbf{Goals of Care}:
|
|
\begin{itemize}
|
|
\item Curative intent vs prolonged disease control vs palliation
|
|
\item Quality of life vs quantity of life trade-offs
|
|
\item Functional independence goals
|
|
\end{itemize}
|
|
|
|
\textbf{Treatment Options Counseling}:
|
|
\begin{itemize}
|
|
\item Expected benefits (median survival, response rates)
|
|
\item Potential harms (toxicity profile, quality of life impact)
|
|
\item Treatment schedule and logistics (frequency of visits, IV vs oral)
|
|
\item Financial considerations (out-of-pocket costs, time off work)
|
|
\end{itemize}
|
|
|
|
\textbf{Decision Aids}:
|
|
\begin{itemize}
|
|
\item Number Needed to Treat: [e.g., Treat X patients to prevent 1 progression event]
|
|
\item Survival benefit visualization: [X-month improvement in median survival]
|
|
\end{itemize}
|
|
|
|
\section{References}
|
|
|
|
\begin{enumerate}
|
|
\item [Primary clinical trial reference]
|
|
\item [Secondary supporting trial]
|
|
\item [NCCN Guidelines, version]
|
|
\item [ASCO/ESMO Guideline reference]
|
|
\item [Meta-analysis or systematic review if applicable]
|
|
\item [Biomarker validation reference]
|
|
\end{enumerate}
|
|
|
|
\vspace{10pt}
|
|
|
|
\hrule
|
|
\vspace{4pt}
|
|
{\footnotesize
|
|
\textbf{Guideline Development Committee}:\\
|
|
[Names and titles of committee members, affiliations]
|
|
|
|
\textbf{Evidence Review Date}: [Date]\\
|
|
\textbf{Guideline Effective Date}: [Date]\\
|
|
\textbf{Next Scheduled Review}: [Date] (or earlier if practice-changing evidence published)
|
|
|
|
\textbf{Conflicts of Interest}: [None / See disclosure statements]
|
|
|
|
\textbf{Methodology}: GRADE framework for evidence evaluation and recommendation development. Systematic literature review conducted [date range]. Guidelines concordance checked with NCCN, ASCO, ESMO current versions.
|
|
|
|
\textbf{For Questions}: Contact [Name], [Title] at [Email/Phone]
|
|
}
|
|
|
|
\end{document}
|
|
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