Table 2:

Guidance on how to analyze and report missing outcome data* in randomized trials

Extent of missing outcome dataHow to analyzeHow to report
Small
  • Main analysis should be intention-to-treat, including participants for whom the outcome was observed

  • Consider performing sensitivity analysis to quantify the effect of missing outcome data (e.g. using multiple imputation, regression adjustment or inverse probability weighting) on study results

  • Baseline characteristics of the participants who were randomized to each study group

  • Proportion of missing outcomes per group

  • Characteristics of participants for whom no outcomes were observed

  • (Possible) reasons for missing outcome data

  • Emphasis on results of the main analysis; results of sensitivity analyses can be discussed in an appendix

Extensive
  • Main analysis might rely on analytical methods that handle missing outcome data (e.g., multiple imputation, regression adjustment or inverse probability weighting), extending an intention-to-treat analysis

  • Baseline characteristics of participants who were assigned to each study group

  • Proportion of missing outcomes per group

  • Characteristics of participants for whom no outcomes were observed

  • (Possible) reasons for missing outcome data

  • Characteristics of participants who were assigned to each study group and who were included in the analysis; this might replace the usual table of baseline characteristics

  • Emphasis on the results of the main intention-to-treat analysis, in which analytical methods to handle missing outcome data were used

  • * One of the drivers of bias due to missing outcome data is the proportion of missing outcome data in relation to the number of events. However, any cut-off is arbitrary. Even less than 5% (notably in the case of rare events) missing outcome data may result in considerable bias if missingness of the outcome is related to prognostic characteristics as well as to treatment. One way to assess the effect of missing outcome data is to use analytical methods that handle missing data and discuss any differences.