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. 2014 Apr;76(4):300-6.
doi: 10.1016/j.jpsychores.2014.01.010. Epub 2014 Feb 7.

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

Doerte U Junghaenel  1 , Stefan Schneider  2 , Arthur A Stone  2 , Christopher Christodoulou  2 , Joan E Broderick  2
Affiliations

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

Doerte U Junghaenel et al. J Psychosom Res. 2014 Apr.

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 4weeks. 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.

Keywords: Anger; Depression; Fatigue; PROMIS®; Premenstrual symptoms; Validity.

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Conflict of interest statement

Competing interest statement: AAS is a Senior Scientist with the Gallup Organization and a Senior Consultant with ERT, inc. JEB has conflicts due to her relationship with AAS.

Figures

Figure 1
Figure 1
Daily and CAT scores over the course of the menstrual cycle for each PRO domain. Grey lines represent the mean daily scores for each day. Blue lines represent the mean of daily averages for each week. Red lines represent the mean CAT scores for each week. Day 0 is the day of menses onset.
Figure 2
Figure 2
Receiver Operating Characteristic (ROC) curves for the prediction of clinically relevant premenstrual symptom increase from change in CAT scores for each PRO domain. Labeled points on each curve represent selected changes in CAT scores, where positive values indicate higher scores in the pre-menstrual compared to the post-menstrual week.
Figure 2
Figure 2
Receiver Operating Characteristic (ROC) curves for the prediction of clinically relevant premenstrual symptom increase from change in CAT scores for each PRO domain. Labeled points on each curve represent selected changes in CAT scores, where positive values indicate higher scores in the pre-menstrual compared to the post-menstrual week.
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