OBJECTIVES:

Since the late 1980s, several methods have been introduced and used to interpret health-related quality of life (HRQoL) and patient-reported outcome measures (PROs) results. The objective of all of them is to devise a way to determine meaningful change in HRQoL and PRO domain or instrument scores. Although there are examples of including patient input into what constitutes a meaningful change that is important to patients and clinically relevant, very limited work has been done. The objective of this study was to document the ways in which patients evaluate scales and think about the meaning of moving up or down on that scale.

METHODS:

Using a semi-structured interview guide to debrief several validated and reliable PROs with MID estimates, trained qualitative interviewers explored patients’ meaning of movement on a scale in several projects. These varied projects produced audiotapes and transcripts of patients’ verbatim reports, which were analyzed using Atlas.ti and synthesized to document how patients think when faced with a scale and what would make them choose an alternative response

RESULTS:

Results indicate that not all patients understand scales as they are intended to be used and that this may be influenced by sociodemographic and cultural factors; that patients give relatively consistent, sensible reasons for what constitutes meaningful change when the scale is comprehensible to them, and clinician and patient definitions of meaningful change differ.

CONCLUSIONS: There is a gap in the clinical meaningfulness research that often excludes the input of patients entirely or uses it in ways that are often too late to make a difference. This research points to methods that can be used to better understand what changes in health status patients want to see from an intervention as a starting point, not to be determined post hoc.