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As Bell  et al . (1) indicated in their paper entitled “Statistical Controversies in Cancer Research: Using standardized effect size graphs to enhance interpretability of cancer-related clinical trials with patient reported outcomes,” Patient Reported Outcomes (PROs) are frequently being gathered in clinical trials. The primary challenge is that these outcomes are multidimensional; rarely is there a single outcome but rather a number of symptoms measures or components of quality of life or health status. While there are formal statistical procedures to insure that the conclusions from a trial about any single outcome is valid (not a false positive), it does not address the clinically relevant questions as to whether the intervention is generally beneficial across the multiple outcomes.

Challenges of interpreting patient reported outcomes from clinical trials