Ecological validity and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue

Abstract

Objective This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. Methods One-hundred women completed daily diaries and weekly PROMIS assessments over 4 weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. Results PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps < .0001) and post-menstrual (ps < .0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. Conclusions PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms.

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“…Items were answered on a 5-point scale ranging from 1 (never) to 5 (always). Items were summed and converted to standardized T-scores; higher T-scores represent more depressive symptoms 48 . Cronbach's alpha was 0.92-0.94.…”

Ambulatory and diary methods can facilitate the measurement of patient-reported outcomes

“…End-of-day diaries, in which patients report their symptoms on a daily basis, often represent a viable alternative where EMA is not feasible or not desirable (e.g., when respondents are not able to respond to momentary prompting) [36–38]. End-of-day ratings require some degree of retrospection (typically, a 24-hr recall period is used).…”

“…Studies comparing recall ratings with aggregated diary ratings over the same reporting period have usually found that symptoms tend to be recalled at higher levels relative to momentary and end-of-day ratings, a phenomenon sometimes referred to as the “experience memory gap” [47]. This effect appears to be robust especially for physical symptoms and negative affective experiences, which are generally rated as more intense, more frequent, and longer lasting in recall [38,40,48–51]. The magnitude of this “gap” between retrospective and diary ratings has been found to be similar for relatively shorter (7-day) and longer (30-day) reporting periods [45,36].…”

“…While some studies have found reasonably high correspondence between aggregated momentary or daily assessments and recall ratings of a week or more [36,38,56–58], others suggest moderate to low correspondence for recall periods beyond one day [45,46,53]. A difficulty associated with tests of agreement between diaries and longer-term recall is that the magnitude of correlations required to judge the scores as sufficiently equivalent is not clear and may differ depending upon the research question [59].…”

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“…High scores suggest a high level of distress while low scores suggest a low level of distress. Fatigue over the past week was assessed using the self-administered 7-item Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale short form [25] , [26] questionnaire which has been validated in women with premenstrual symptoms [27] and in osteoarthritis patients [28] .…”