Dataset Information

Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples.

ABSTRACT: The purpose of this study was to evaluate the responsiveness to change of the PROMIS negative affect measures (depression, anxiety, and anger) using longitudinal data collected in six chronic health conditions.Individuals with major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed PROMIS negative affect instruments as computerized adaptive test or as fixed-length short form at baseline and a clinically relevant follow-up interval. Participants also completed global ratings of health. Linear mixed effects models and standardized response means (SRM) were estimated at baseline and follow-up.A total of 903 individuals participated (back pain, n = 218; cancer, n = 304; CHF, n = 60; COPD, n = 125; MDD, n = 196). All three negative affect instruments improved significantly for treatments of depression and pain. Depression improved for CHF patients (anxiety and anger not administered), whereas anxiety improved significantly in COPD groups (stable and exacerbation). Response to treatment was not assessed in cancer. Subgroups of patients reporting better or worse health showed a corresponding positive or negative average SRM for negative affect across samples.This study provides evidence that the PROMIS negative affect scores are sensitive to change in intervention studies in which negative affect is expected to change. These results inform the estimation of meaningful change and enable comparative effectiveness research.

SUBMITTER: Schalet BD

PROVIDER: S-EPMC4928679 | biostudies-other | 2016 May

REPOSITORIES: biostudies-other

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Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples.

Schalet Benjamin D BD Pilkonis Paul A PA Yu Lan L Dodds Nathan N Johnston Kelly L KL Yount Susan S Riley William W Cella David D

Journal of clinical epidemiology 20160227

<h4>Objectives</h4>The purpose of this study was to evaluate the responsiveness to change of the PROMIS negative affect measures (depression, anxiety, and anger) using longitudinal data collected in six chronic health conditions.<h4>Study design and setting</h4>Individuals with major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed PROMIS negative affect instruments as computerized adaptive test or as fixed-leng ...[more]

PMID: 26931289

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Project description:Background: Determinants of changes in cognitive function during aging are not well-understood. We aimed to estimate the effects of depression-, anxiety- and anger symptoms on cognition and on cognition changes, especially on changes in episodic memory (EM) and executive functioning (EF). Methods: We analyze data from the Mid-Life in the Midlife in the United States Biomarker study at two time points including n = 710 women, and n = 542 men (1996/1997) at the first assessment and n = 669 women, and n = 514 men at the second assessment (2013/2014). To assess cognition we used the Brief Test of Adult Cognition (BTACT). To measure depression-, anxiety- and anger symptoms we used the Mood and Anxiety Symptom Questionnaire (MASQ), the Center for Epidemiologic Studies Depression Scale (CES-D) and the State-Trait Anger Expression Inventory (STAXI). We used repeated models analyses to explore changes in cognition, and repeated measures linear mixed-effects models to investigate depression, anxiety and anger effects on cognition. All analyses were adjusted for potential confounders (cognition at baseline, age, education, income). Results: At the first assessment, women had significantly better episodic memory functioning than men; men in the oldest age group had significant better executive functioning. At the second assessment, more education, and white ethnicity were associated with less negative changes on episodic memory and executive functioning. Depression- and anger symptoms were associated with declines in episodic memory among women; anxiety symptoms were associated with declines in episodic memory and executive functioning in both gender in men (EF: β: -0.02, (95% CI: -0.03, -0.01; EM: β -0.02 (-0.02, 95% CI: -0.03, -0.01) and in women (EF: β -0.01, 95% CI: -0.02, -0.0004; EM: β -0.013, 95% CI: -0.03, -0.001). Conclusions: Depression-, anxiety- and anger symptoms were associated with changes in episodic memory and executive functioning. Further longitudinal studies are critical in populations in more countries to better understand the impact of depression, anxiety and anger symptoms on cognition changes.

Project description:BackgroundThe current study was conducted to evaluate the Patient-Reported Outcomes Measurement Information System Depression Short Form (PROMIS-D-SF) as a screening measure for young adult cancer survivors (YACS) compared with a structured diagnostic interview.MethodsA total of 249 YACS (aged 18-40 years) completed the PROMIS-D-SF and Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID). Based on the SCID, participants were classified as having: 1) an SCID depression diagnosis; 2) depression symptoms without an SCID diagnosis; or 3) no depression symptoms. Receiver operating characteristic analyses evaluated PROMIS-D-SF and SCID concordance and the sensitivity and specificity of PROMIS-D-SF cutoff t -scores.ResultsThe PROMIS-D-SF had overall good agreement with the SCID for both depression diagnosis (area under the curve, 0.89) and the presence of depressive symptoms (area under the curve, 0.83). A PROMIS-D-SF cutoff t-score of ≥53.2 came closest to meeting study criteria for detecting a SCID depression diagnosis (sensitivity ≥0.85 and specificity ≥0.75), with a sensitivity of 0.81 and a specificity of 0.74. For identifying survivors with depression symptoms, a t-score cutoff value of 49.4 was found to have slightly superior sensitivity (0.84) and inferior specificity (0.64). In hypothetical screening examples, these cutoff scores led to moderate levels of missed cases (15%-19%) and a high percentage of clinical referrals that were unnecessary by SCID criteria (56%-70%).ConclusionsThe PROMIS-D-SF demonstrated moderately strong concordance with depressive diagnoses and symptoms measured by the SCID, but cutoff t-scores did not meet study criteria for clinical screening. The PROMIS-D-SF may be useful for assessing depression in YACS, but the limitations in its sensitivity and specificity identified in the current study are likely to limit its usefulness as a stand-alone screening instrument in this population.

Project description:This is the first study of the measurement equivalence of the Patient Reported Outcomes Measurement Information System® (PROMIS®) Anxiety short forms in a large ethnically diverse sample. The psychometric properties and differential item functioning (DIF) were examined across different racial/ethnic, educational, age, gender and language groups. METHODS:These data are from individuals selected from cancer registries in the United States. For the analyses of race/ethnicity the reference group was non-Hispanic Whites (n = 2,263), the studied groups were non-Hispanic Blacks (n = 1,117), Hispanics (n = 1,043) and Asians/Pacific Islanders (n = 907). Within the Hispanic subsample, there were 335 interviews conducted in Spanish and 703 in English. The 11 anxiety items were from the PROMIS emotional disturbance item bank. DIF hypotheses were generated by content experts who rated whether or not they expected DIF to be present, and the direction of the DIF with respect to several comparison groups. The primary method used for DIF detection was the Wald test for examination of group differences in item response theory (IRT) item parameters accompanied by magnitude measures. Expected item scores were examined as measures of magnitude. The method used for quantification of the difference in the average expected item scores was the non-compensatory DIF (NCDIF) index. DIF impact was examined using expected scale score functions. Additionally, precision and reliabilities were examined using several methods. RESULTS:Although not hypothesized to show DIF for Asians/Pacific Islanders, every item evidenced DIF by at least one method. Two items showed DIF of higher magnitude for Asians/Pacific Islanders vs. Whites: "Many situations made me worry" and "I felt anxious". However, the magnitude of DIF was small and the NCDIF statistics were not above threshold. The impact of DIF was negligible. For education, six items were identified with consistent DIF across methods: fearful, anxious, worried, hard to focus, uneasy and tense. However, the NCDIF was not above threshold and the impact of DIF on the scale was trivial. No items showed high magnitude DIF for gender. Two items showed slightly higher magnitude for age (although not above the cutoff): worried and fearful. The scale level impact was trivial. Only one item showed DIF with the Wald test after the Bonferroni correction for the language comparisons: "I felt fearful". Two additional items were flagged in sensitivity analyses after Bonferroni correction, anxious and many situations made me worry. The latter item also showed DIF of higher magnitude, with an NCDIF value (0.144) above threshold. Individual impact was relatively small. CONCLUSIONS:Although many items from the PROMIS short form anxiety measures were flagged with DIF, item level magnitude was low and scale level DIF impact was minimal; however, three items: anxious, worried and many situations made me worry might be singled out for further study. It is concluded that the PROMIS Anxiety short form evidenced good psychometric properties, was relatively invariant across the groups studied, and performed well among ethnically diverse subgroups of Blacks, Hispanic, White non-Hispanic and Asians/Pacific Islanders. In general more research with the Asians/Pacific Islanders group is needed. Further study of subgroups within these broad categories is recommended.

Dataset Information

Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples.

Publications

Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples.

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