# Data Presentation in Clinical Reports ## Tables for Clinical Data ### Table Design Principles **General guidelines:** - Clear, concise title describing table contents - Column headers with units - Row labels aligned left, data aligned appropriately (numbers right, text left) - Footnotes for abbreviations, statistical notation, special cases - Consistent decimal places (typically 1-2 for percentages, 1-3 for continuous variables) - Consistent formatting throughout document **Title placement:** - Above table - Numbered sequentially (Table 1, Table 2, etc.) - Descriptive enough to stand alone **Footnote symbols (in order):** - *, †, ‡, §, ||, ¶, # - Or use superscript letters (a, b, c...) - Or use superscript numbers if not confused with references ### Demographic and Baseline Characteristics Table **Purpose:** Describe study population at baseline **Standard format:** ``` Table 1. Baseline Demographics and Clinical Characteristics Characteristic Treatment Group Control Group Total (N=150) (N=145) (N=295) ───────────────────────────────────────────────────────────────────────── Age, years Mean (SD) 64.2 (8.5) 63.8 (9.1) 64.0 (8.8) Median (IQR) 65 (58-71) 64 (57-70) 64 (58-71) Range 45-82 43-85 43-85 Sex, n (%) Male 95 (63.3) 88 (60.7) 183 (62.0) Female 55 (36.7) 57 (39.3) 112 (38.0) Race, n (%) White 110 (73.3) 105 (72.4) 215 (72.9) Black/African American 25 (16.7) 28 (19.3) 53 (18.0) Asian 10 (6.7) 8 (5.5) 18 (6.1) Other 5 (3.3) 4 (2.8) 9 (3.0) BMI, kg/m² Mean (SD) 28.5 (4.2) 28.1 (4.5) 28.3 (4.4) Baseline HbA1c, % Mean (SD) 8.9 (1.2) 9.0 (1.3) 9.0 (1.2) Disease duration, years Median (IQR) 6 (3-10) 5 (3-9) 6 (3-10) Prior medications, n (%) Metformin 135 (90.0) 130 (89.7) 265 (89.8) Sulfonylurea 45 (30.0) 42 (29.0) 87 (29.5) Insulin 20 (13.3) 18 (12.4) 38 (12.9) ───────────────────────────────────────────────────────────────────────── SD = standard deviation; IQR = interquartile range; BMI = body mass index; HbA1c = hemoglobin A1c ``` **Key elements:** - Sample size for each group (N=) - Continuous variables: mean (SD), median (IQR), range - Categorical variables: n (%) - No p-values for baseline comparisons (debated but generally not recommended) ### Efficacy Results Table **Purpose:** Present primary and secondary endpoint results **Example:** ``` Table 2. Primary and Secondary Efficacy Endpoints at Week 24 Endpoint Treatment Control Difference P-value (N=150) (N=145) (95% CI) ────────────────────────────────────────────────────────────────────────────────── Primary Endpoint Change in HbA1c from baseline, % Mean (SE) -1.8 (0.1) -0.6 (0.1) -1.2 <0.001 95% CI (-2.0, -1.6) (-0.8, -0.4) (-1.5, -0.9) Secondary Endpoints Change in FPG, mg/dL Mean (SE) -42.5 (3.2) -15.2 (3.4) -27.3 <0.001 95% CI (-48.8, -36.2) (-21.9, -8.5) (-36.4, -18.2) % achieving HbA1c <7% n (%) 78 (52.0) 25 (17.2) - <0.001 95% CI (43.9, 60.1) (11.4, 24.5) Change in body weight, kg Mean (SE) -3.2 (0.4) -0.5 (0.4) -2.7 <0.001 95% CI (-4.0, -2.4) (-1.3, 0.3) (-3.8, -1.6) ────────────────────────────────────────────────────────────────────────────── SE = standard error; CI = confidence interval; HbA1c = hemoglobin A1c; FPG = fasting plasma glucose ``` **Statistical presentation:** - Point estimates with measures of precision (SE or CI) - p-values (consider adjustment for multiplicity) - Effect size (difference or ratio) with 95% CI - Significance level noted (e.g., p<0.05, p<0.01, p<0.001) ### Adverse Events Table **Purpose:** Summarize safety data **Example:** ``` Table 3. Summary of Adverse Events Event Category Treatment Control P-value (N=150) (N=145) n (%) n (%) ────────────────────────────────────────────────────────────────────────── Any adverse event 120 (80.0) 95 (65.5) 0.004 Treatment-related adverse events 85 (56.7) 42 (29.0) <0.001 Serious adverse events 12 (8.0) 8 (5.5) 0.412 Adverse events leading to 8 (5.3) 4 (2.8) 0.257 discontinuation Deaths 0 (0.0) 1 (0.7) 0.492 Common adverse events (≥5% in any group) Nausea 45 (30.0) 12 (8.3) <0.001 Diarrhea 38 (25.3) 10 (6.9) <0.001 Headache 22 (14.7) 18 (12.4) 0.568 Hypoglycemia 18 (12.0) 5 (3.4) 0.007 Dizziness 12 (8.0) 8 (5.5) 0.412 ────────────────────────────────────────────────────────────────────────── Adverse events coded using MedDRA version 24.0 ``` **Key elements:** - Overall AE summary - Serious AEs highlighted - Deaths reported - Common AEs (typically ≥5% or ≥10% threshold) - MedDRA coding indicated ### Laboratory Abnormalities Table **Shift tables showing changes from baseline:** ``` Table 4. Laboratory Values Meeting Predefined Criteria for Abnormality Laboratory Parameter Treatment Control (N=150) (N=145) n (%) n (%) ────────────────────────────────────────────────────────────────────────── ALT >3× ULN 8 (5.3) 3 (2.1) AST >3× ULN 5 (3.3) 2 (1.4) Total bilirubin >2× ULN 2 (1.3) 1 (0.7) Creatinine >1.5× baseline 12 (8.0) 5 (3.4) Hemoglobin <10 g/dL 3 (2.0) 2 (1.4) Platelets <100 × 10³/μL 1 (0.7) 0 (0.0) ────────────────────────────────────────────────────────────────────────── ULN = upper limit of normal; ALT = alanine aminotransferase; AST = aspartate aminotransferase ``` ### Patient Disposition Table (CONSORT Format) ``` Table 5. Patient Disposition Disposition Treatment Control Total (N=150) (N=145) (N=295) ──────────────────────────────────────────────────────────────────────────── Screened - - 425 Randomized 150 145 295 Completed study 135 (90.0) 130 (89.7) 265 (89.8) Discontinued, n (%) 15 (10.0) 15 (10.3) 30 (10.2) Adverse event 8 (5.3) 4 (2.8) 12 (4.1) Lack of efficacy 2 (1.3) 5 (3.4) 7 (2.4) Lost to follow-up 3 (2.0) 4 (2.8) 7 (2.4) Withdrawal of consent 2 (1.3) 2 (1.4) 4 (1.4) Included in efficacy analysis ITT population 150 (100) 145 (100) 295 (100) Per-protocol population 142 (94.7) 138 (95.2) 280 (94.9) Included in safety analysis 150 (100) 145 (100) 295 (100) ──────────────────────────────────────────────────────────────────────────── ITT = intent-to-treat ``` ## Figures for Clinical Data ### Figure Design Principles **General guidelines:** - Clear, concise caption/legend below figure - Numbered sequentially (Figure 1, Figure 2, etc.) - Axis labels with units - Legible font size (minimum 8-10 point) - High resolution (300 dpi for print, 150 dpi for web) - Color-blind friendly palette - Black and white compatible (use different symbols/patterns) **Figure caption:** - Describes what is shown - Explains symbols, error bars, statistical annotations - Defines abbreviations - Provides context for interpretation ### CONSORT Flow Diagram **Purpose:** Show patient flow through randomized trial ``` Assessed for eligibility (n=425) │ ┌─────────────────────┴─────────────────────┐ │ │ Excluded (n=130) │ • Not meeting inclusion criteria (n=85) │ • Declined to participate (n=32) │ • Other reasons (n=13) │ │ Randomized (n=295) │ ┌───────────────────────────────┴───────────────────────────────┐ │ │ Allocated to Treatment (n=150) Allocated to Control (n=145) • Received allocated intervention (n=148) • Received allocated intervention (n=143) • Did not receive allocated intervention (n=2) • Did not receive allocated intervention (n=2) Reasons: withdrew consent before treatment Reasons: withdrew consent before treatment │ │ ┌───────────┴────────────┐ ┌──────────────┴─────────────┐ │ │ │ │ Lost to follow-up (n=3) Discontinued (n=12) Lost to follow-up (n=4) Discontinued (n=11) • Adverse events (n=8) • Adverse events (n=4) • Lack of efficacy (n=2) • Lack of efficacy (n=5) • Withdrew consent (n=2) • Withdrew consent (n=2) │ │ Analyzed (n=150) Analyzed (n=145) • ITT analysis (n=150) • ITT analysis (n=145) • Per-protocol analysis (n=142) • Per-protocol analysis (n=138) • Excluded from analysis (n=0) • Excluded from analysis (n=0) ``` ### Kaplan-Meier Survival Curve **Purpose:** Show time-to-event data **Elements:** - X-axis: Time (weeks, months, years) - Y-axis: Probability of event-free survival (0 to 1 or 0% to 100%) - Separate curves for each treatment group - Censored observations marked (often with vertical tick marks) - Number at risk table below graph - Median survival time indicated - Log-rank p-value - Hazard ratio with 95% CI **Caption example:** ``` Figure 1. Kaplan-Meier Curves for Overall Survival Kaplan-Meier estimates of overall survival in the treatment and control groups. Tick marks indicate censored observations. Number at risk shown below graph. Log-rank p<0.001. Median survival: Treatment 24.5 months (95% CI: 22.1-26.8), Control 18.2 months (95% CI: 16.5-20.1). Hazard ratio 0.68 (95% CI: 0.55-0.84). ``` ### Forest Plot **Purpose:** Display subgroup analyses or meta-analysis results **Elements:** - Point estimates (squares or diamonds) - Size of symbol proportional to precision (inverse variance) or sample size - Horizontal lines showing 95% CI - Vertical line at null effect (HR=1.0, OR=1.0, or difference=0) - Subgroup labels on left - Effect size values on right - Overall estimate (if meta-analysis) - Heterogeneity statistics (I², p-value) **Caption example:** ``` Figure 2. Forest Plot of Treatment Effect by Subgroup Effect of treatment vs. control on primary endpoint across pre-specified subgroups. Squares represent point estimates; horizontal lines represent 95% confidence intervals. Square size is proportional to subgroup sample size. Overall effect shown as diamond. p-value for interaction testing heterogeneity of treatment effect across subgroups. ``` ### Box Plot **Purpose:** Show distribution of continuous variable **Elements:** - Box: IQR (25th to 75th percentile) - Line in box: Median - Whiskers: Extend to most extreme data point within 1.5 × IQR - Outliers: Points beyond whiskers (often shown as circles) - X-axis: Groups or time points - Y-axis: Continuous variable with units ### Scatter Plot with Regression **Purpose:** Show relationship between two continuous variables **Elements:** - X-axis: Independent variable - Y-axis: Dependent variable - Individual data points - Regression line (if appropriate) - Regression equation - R² value - P-value for slope - 95% confidence interval for regression line (optional, shown as shaded area) ### Spaghetti Plot **Purpose:** Show individual trajectories over time **Elements:** - X-axis: Time - Y-axis: Outcome variable - Individual patient lines (often semi-transparent) - Mean trajectory (bold line) - Separate colors for treatment groups ### Bar Chart **Purpose:** Compare proportions or means across groups **Elements:** - Clear separation between bars - Error bars (SEM or 95% CI) - Y-axis starts at 0 (do not truncate for bar charts) - Group labels on X-axis - Value labels on Y-axis with units - Statistical significance indicated (p-values or asterisks) **Avoid:** - 3D bar charts (distort perception) - Excessive decoration - Truncated Y-axis for bars ### Line Graph **Purpose:** Show changes over time **Elements:** - X-axis: Time (with consistent intervals) - Y-axis: Outcome variable - Separate lines for each group (different colors/patterns) - Data points marked (circles, squares, triangles) - Error bars at each time point (SE or 95% CI) - Legend identifying groups - Grid lines (optional, light gray) ### Histogram **Purpose:** Show distribution of continuous variable **Elements:** - X-axis: Variable (divided into bins) - Y-axis: Frequency or density - Appropriate bin width (not too few, not too many) - Overlay normal distribution curve (if testing normality) ## Special Considerations for Clinical Data ### Presenting Proportions **Numerator and denominator:** - Always provide both: 25/100 (25%) - Not just percentage (25%) **Percentages:** - No decimal places if n<100 - 1 decimal place if n≥100 - Never report >1 decimal place for percentages **Confidence intervals for proportions:** - Wilson score interval or exact binomial (better than Wald for small samples) - Always report with percentage ### Presenting Continuous Data **Measures of central tendency:** - Mean for normally distributed data - Median for skewed data or ordinal data - Report both if distribution unclear **Measures of dispersion:** - **Standard deviation (SD)**: Describes variability in data - **Standard error (SE)**: Describes precision of mean estimate - **95% Confidence interval**: Preferred for inferential statistics - **Interquartile range (IQR)**: With median for skewed data - **Range**: Min to max **When to use each:** - Descriptive statistics → Mean (SD) or Median (IQR) - Inferential statistics → Mean (95% CI) or Mean (SE) - Never use ± without specifying SD, SE, or CI ### Presenting P-values **Reporting guidelines:** - Report exact p-values to 2-3 decimal places (p=0.042) - For very small p-values, use p<0.001 (not p=0.000) - Do not report as "NS" or "p=NS" - For non-significant results, report exact p-value (p=0.18, not p>0.05) - Specify two-tailed unless pre-specified one-tailed - Correct for multiple comparisons when appropriate - Report significance threshold used (α=0.05 is standard) **Avoid:** - p<0.05 (report exact value) - p=0.00 (impossible) - Multiple decimal places (p=0.04235891) ### Statistical Significance Indicators **Options:** 1. Report p-values in table 2. Use asterisks with legend: - *p<0.05 - **p<0.01 - ***p<0.001 3. Use confidence intervals (preferred) ### Confidence Intervals **Reporting:** - 95% CI is standard - Format: (lower limit, upper limit) - Or: lower limit to upper limit - Or: lower limit-upper limit **Interpretation:** - If CI for difference excludes 0 → significant - If CI for ratio excludes 1 → significant - Width of CI indicates precision ### Missing Data **Indicate clearly:** - Footnote explaining missing data - State clearly if analysis is complete case - Describe imputation method if used - Report amount of missing data per variable ### Decimal Places and Rounding **General rules:** - Report to level of measurement precision - Consistent decimal places within table - Round p-values to 2-3 decimal places - Round percentages to 0-1 decimal place - Round means/medians to 1-2 decimal places - Include appropriate significant figures ## Software for Creating Figures **Statistical software:** - R (ggplot2) - highly customizable - GraphPad Prism - user-friendly for biomedical - SAS, Stata, SPSS - comprehensive statistical packages - Python (matplotlib, seaborn) - flexible and powerful **General graphics software:** - Adobe Illustrator - professional publication-quality - Inkscape - free vector graphics editor - PowerPoint - basic graphs, easy to use - BioRender - biological schematics and figures ## Color Schemes **Color-blind friendly palettes:** - Avoid red-green combinations - Use blue-orange, blue-yellow - Include shape/pattern differences - Test figures in grayscale **Recommended palettes:** - ColorBrewer (designed for data visualization) - Viridis (perceptually uniform) - IBM Color Blind Safe Palette ## Image Quality Standards **Resolution:** - 300 dpi for print publication - 150 dpi for web/screen - Vector graphics (PDF, SVG) preferred for graphs **File formats:** - TIFF or EPS for print - PNG for web - PDF for vector graphics - JPEG acceptable for photographs (high quality) **Image editing:** - No manipulation that alters data - Only acceptable adjustments: brightness, contrast, color balance applied to entire image - Document all adjustments - Provide original images if requested --- This reference provides comprehensive guidance for presenting clinical data in tables and figures following best practices and publication standards. Use these guidelines to create clear, accurate, and professional data presentations.