Clinical Trials

❘❙❚■ Chapter 35 | Use of TablesAdjustmentsIf analyses are adjusted, remember to specify what characteristics have beenadjusted for. Clinical trials often report unadjusted results, unless stated otherwisein the protocol, which should then specify one or two things to adjust for or stratifyby. For instance, the results might be stratified by recruitment center, or by patientcharacteristics used in stratified randomization.UnitsMake sure the units are quoted in the column or row headings, and ensure that allunits are in accordance with the journal policy.Reported numbersIndicate the total numbers of patients that are being reported on – this could beincluded within the title row, if the same numbers are used for all analyses;otherwise, this information might need to be incorporated within the body of thetable, perhaps to reflect different amounts of missing data for different outcomeor predictor variables.Analysis methodState whether the analysis is by intention-to-treat or per-protocol analysis, or anyother method. If the analysis method is not mentioned in the table then it must bestated in the text.RoundingAny totals given should be calculated from the data before rounding. If data arerounded in the table, the publication should state that differences might occurbetween sums of component items and totals because of rounding.Footnotes/referencesUse footnotes for important information that does not fit elsewhere. Referencescited only in tables (or in legends to figures) should be numbered in accordancewith a sequence established by the first identification in the text of that particulartable (or illustration) [8].Presenting numeric data in text and within fields of tablesThe term ‘field’ refers to the cells where the numbers (or occasionally textinformation) are put within the table. Remember that the requirement to giveunits of measurement and to indicate the number of patients used in results (oftenreported in row or column headings of a table) also applies to data given withinthe text of the results section.402