Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘LayoutConsider the layout of the table and anything that might make it easier to read –eg, subheadings, blank lines, or use of parentheses around 95% CIs oraround percentages.TotalsIt might be desirable to include a row of totals, and sometimes subtotals –eg, when giving several different causes of death (Table 1). When two treatmentarms are being compared, with information for each in a separate column, it isusually unhelpful to include a totals column to combine information from bothtrial arms. Consider adding a column combining treatment groups only if you havetwo similar treatments arms that can usefully be considered in combination,for comparison with the placebo group or another treatment group.Titles and footnotesTitle/headingsThe title should be a concise description of the information contained within thetable. Row headings and column headings should describe what lies within them– where longer descriptions are necessary, supplementary information can begiven in a footnote. If most/all columns contain the same type of information,details of this should be included in the table title or in a footnote, rather thanin individual row headings (eg, footnote: “data are given as mean [standarddeviation] unless stated otherwise”).Explanatory informationRemember that tables need to fully explain what is being compared. For instance,if quoting odds ratios, hazard ratios, or relative risks, state what outcome theratios represent and which groups are being compared. The reader might need tolook at row, column, and title headings to find all of this information.Follow-up/outcomesProvide the time to follow-up in the title of the table unless the trial has only onetime line (ie, all patients were followed to 12 months). When outcomes that are notas final as death are included, it is important to specify whether the table reflects:• the first outcome a patient suffers (as in a survival analysis)• the worst outcome a patient suffers (hierarchical reporting)• all outcomes separately (includes double counting if a patient suffersmore than one event)The specific method of reporting can be placed in the methods section of the text.401