title: 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 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.
authors.affiliation: Department of Psychiatry and Behavioral Science, Stony Brook University, United States. Electronic address: Doerte.Junghaenel@stonybrook.edu.
authors.forename: Doerte U
authors.initials: DU
authors.lastname: Junghaenel
authors.affiliation: Department of Psychiatry and Behavioral Science, Stony Brook University, United States.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schneider
authors.affiliation: Department of Psychiatry and Behavioral Science, Stony Brook University, United States.
authors.forename: Arthur A
authors.initials: AA
authors.lastname: Stone
authors.affiliation: Department of Psychiatry and Behavioral Science, Stony Brook University, United States.
authors.forename: Christopher
authors.initials: C
authors.lastname: Christodoulou
authors.affiliation: Department of Psychiatry and Behavioral Science, Stony Brook University, United States.
authors.forename: Joan E
authors.initials: JE
authors.lastname: Broderick
mesh_terms: D000293:Adolescent; D000328:Adult; D000342:Affective Symptoms / Q000175:diagnosis*; D000786:Anger; D003863:Depression / Q000175:diagnosis*; D005221:Fatigue / Q000175:diagnosis*; D005260:Female; D006801:Humans; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011293:Premenstrual Syndrome / Q000175:diagnosis*; D015203:Reproducibility of Results; D013997:Time Factors
keywords: Anger; Depression; Fatigue; PROMIS®; Premenstrual symptoms; Validity