Clinical significance of patient-reported questionnaire data: two more steps?

Really, the clinician is not the metric here. Because the term "patient-determined meaningfulness" is a bit of a mouthful, maybe we should just talk in terms of meaningful HRQL effects and leave out the term "clinical?" My second suggested step goes beyond psychometrics and focuses on how we discern meaningful effects from clinical and HRQL endpoints in RCTs. The same could and should be done for HRQL endpoints. [...]the determination of a meaningful within-subject change is of paramount importance for the interpretation of HRQL endpoints included in RCTs.