PROMIS fatigue, pain intensity, pain interference, pain behavior, physical function, depression, anxiety, and anger scales demonstrate ecological validity.

Ecological validity refers to the degree to which instruments faithfully capture information in respondents' natural environments. We examined the ecological validity of eight instruments from the Patient Reported Outcomes Measurement Information System (PROMIS), most of which use 7-day reporting periods, by comparing PROMIS scores with daily diary data as a standard.

Five groups of approximately 100 respondents each completed daily diaries and weekly PROMIS instruments for 4 consecutive weeks: community residents; osteoarthritis patients; women experiencing premenstrual syndrome; men undergoing hernia surgery; and breast cancer patients receiving chemotherapy. The last three groups experienced events (menses, surgery, or chemotherapy, respectively) at standardized times in the protocol to examine symptom changes attributable to these events.

We examined the ability of the PROMIS scales to replicate between-group differences in diaries, to replicate week-to-week changes in diaries, and the correlation between diary and PROMIS scales. As a secondary aim, we examined known-group differences with the PROMIS measures. All three types of ecological validity were strongly confirmed, as was known-group validity for the PROMIS recall scales.

This study adds to the growing literature supporting the reliability and validity of the family of PROMIS instruments.