Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS®) in a three-month observational study

Abstract

The Patient-Reported Outcomes Measurement Information System (PROMIS®) is an NIH Roadmap initiative devoted to developing better measurement tools for assessing constructs relevant to the clinical investigation and treatment of all diseases—constructs such as pain, fatigue, emotional distress, sleep, physical functioning, and social participation. Following creation of item banks for these constructs, our priority has been to validate them, most often in short-term observational studies. We report here on a three-month prospective observational study with depressed outpatients in the early stages of a new treatment episode (with assessments at intake, one-month follow-up, and three-month follow-up). The protocol was designed to compare the psychometric properties of the PROMIS depression item bank (administered as a computerized adaptive test, CAT) with two legacy self-report instruments: the Center for Epidemiological Studies Depression scale (CESD; Radloff, 1977) and the Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999). PROMIS depression demonstrated strong convergent validity with the CESD and the PHQ-9 (with correlations in a range from .72 to .84 across all time points), as well as responsiveness to change when characterizing symptom severity in a clinical outpatient sample. Identification of patients as “recovered” varied across the measures, with the PHQ-9 being the most conservative. The use of calibrations based on models from item response theory (IRT) provides advantages for PROMIS depression both psychometrically (creating the possibility of adaptive testing, providing a broader effective range of measurement, and generating greater precision) and practically (these psychometric advantages can be achieved with fewer items—a median of 4 items administered by CAT—resulting in less patient burden).

Testing the PROMIS ® Depression measures for monitoring depression in a clinical sample outside the US

“…Correlations among PROMIS Depression and anxiety measures were located on the upper bound of the moderate level range, and were lower than those between the PHQ-9 and the anxiety measures. Previous studies, in general population (Cella et al, 2010;Pilkonis et al, 2011) and patient samples (Amtmann et al, 2014;Bajaj et al, 2011;Pilkonis et al, 2014) found similar results, with moderate to high correlations of PROMIS Depression with other anxiety measures. The fact that in our study PROMIS Depression measures were able to discriminate between depression and anxiety, with large effect sizes among individuals with depression, and small effect sizes in patients with GAD or panic without depression supports high discriminant and diagnostic validity of the instrument.…”

“…Of greatest concern is the evaluation of construct validity and responsiveness in patient samples relevant to the construct of interest. PROMIS Depression has shown good results in patients with major depression (Pilkonis et al, 2014) and other conditions (Amtmann et al, 2014). However, the psychometric properties of the PROMIS Depression measures in Spanish or other language versions have not been evaluated so far.…”

Loneliness Mediates the Relationship Between Pain During Intercourse and Depressive Symptoms Among Young Women

“…None of the items were related to social connectedness, loneliness, or social isolation. The PROMIS Depression Scale has shown good convergent validity through its significant correlations, across multiple time points, with the Patient Health Questionnaire-9 and the Center for Epidemiologic Studies Depression scale (correlations ranged from .72 to .84; Pilkonis et al, 2014). Further, it demonstrated good reliability (alpha = 0.94) in the current study.…”

Association Between Social Media Use and Depression Among U.S. Young Adults

“…[28] Specifically, the PROMIS depression scale has been correlated and validated with other commonly used depression instruments, including the Center for Epidemiological Studies Depression Scale (CES-D), the Beck Depression Inventory (BDI-II), and the Patient Health Questionnaire (PHQ-9). [29,30] The 4-item PROMIS depression scale asked participants how frequently in the past 7 days they had experienced depression, including feeling hopeless, worthless, helpless, or depressed. [31] These items were scored on a 5-point Likert scale ranging from 1 to 5, corresponding to responses of “Never,” “Rarely,” “Sometimes,” “Often” and “Always.” Thus, the total possible raw score was between 4 and 20.…”