Dataset Information

Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.

ABSTRACT: BACKGROUND:Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials. OBJECTIVES:The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain. METHODS:In a phase III double-blind, placebo-controlled clinical trial (NCT01620528), women aged 18-49?years with moderate-to-severe endometriosis-related pain were randomized to elagolix 150?mg once daily, elagolix 200?mg twice daily, or placebo for 6?months. PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6. Reliability (internal consistency and test-retest reliability), construct validity (convergent and known groups validity), and responsiveness were evaluated. RESULTS:The analysis included 871 women, mean age 31.5?years. Internal consistency supported a single concept (Cronbach's alpha 0.93). For the 238 patients with no change in PGIC at month 1, the intraclass correlation coefficient for the PROMIS Fatigue T-score was 0.7 and paired t-test statistically significant (2.84, p =?0.0049). Correlations with other measures were expected to be fairly low as concepts were not redundant. The PROMIS Fatigue discriminated among known groups with mean scores of 55.3, 62.3, and 65.8 at month 3 (PGIC improvement, no change, worsening, respectively). Statically significant discrimination, and change score responsiveness, were seen using clinically relevant anchors (dysmenorrhea and NMPP) at months 3 and 6 between responders and non-responders. Anchor-based (PGIC) responsiveness showed significant improvement from baseline to months 3 and 6 (p

SUBMITTER: Pokrzywinski R

PROVIDER: S-EPMC7591638 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.

Pokrzywinski Robin R Soliman Ahmed M AM Surrey Eric E Snabes Michael C MC Coyne Karin S KS

Journal of patient-reported outcomes 20201027 1

<h4>Background</h4>Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials.<h4>Objectives</h4>The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.<h4>Methods</h4>In a phase III double-blind, placebo-controlled c ...[more]

PMID: 33108543

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Project description:The need for reliable, valid tools to measure patient-reported outcomes (PROs) is critical both for research and for evaluating treatment effects in practice. The Patient-Reported Outcomes Measurement Information System Fatigue-Short Form v1.0-Fatigue 7a (PROMIS F-SF) has had limited psychometric evaluation in various populations.The aim of the study is to examine psychometric properties of PROMIS F-SF item responses across various populations.Data from five studies with common data elements were used in this secondary analysis. Samples from patients with fibromyalgia, sickle cell disease, cardiometabolic risk, pregnancy, and healthy controls were used. Reliability was estimated using Cronbach's alpha. Dimensionality was evaluated with confirmatory factor analysis. Concurrent validity was evaluated by examining Pearson's correlations between scores from the PROMIS F-SF, the Multidimensional Fatigue Symptom Inventory-Short Form, and the Brief Fatigue Inventory. Discriminant validity was evaluated by examining Pearson's correlations between scores on the PROMIS F-SF and measures of stress and depressive symptoms. Known groups validity was assessed by comparing PROMIS F-SF scores in the clinical samples to healthy controls.Reliability of PROMIS F-SF scores was adequate across samples, ranging from .72 in the pregnancy sample to .88 in healthy controls. Unidimensionality was supported in each sample. Concurrent validity was strong; across the groups, correlations with scores on the Multidimensional Fatigue Symptom Inventory-Short Form and Brief Fatigue Inventory ranged from .60 to .85. Correlations of the PROMIS F-SF with measures of stress and depressive mood were moderate to strong, ranging from .37 to .64. PROMIS F-SF scores were significantly higher in clinical samples compared to healthy controls.Reliability and validity of the PROMIS F-SF were acceptable. The PROMIS F-SF is a suitable measure of fatigue across the four diverse clinical populations included in the analysis.

Project description:BackgroundThere has recently been growing interest in the roles of inflammation in contributing to the development of anxiety in people with immune-mediated inflammatory diseases (IMID). Patient-reported outcome measures can facilitate the assessment of physical and psychological functioning. The National Institutes of Health (NIH)'s Patient-Reported Outcomes Measurement Information System (PROMIS®) is a set of Patient-Reported Outcomes (PROs) that cover physical appearance, mental health, and social health. The PROMIS has been built through an Item Response Theory approach (IRT), a model-based measurement in which trait level estimates depend on both persons' responses and on the properties of the items that were administered. The aim of this study is to test the psychometric properties of an Italian custom four-item Short Form of the PROMIS Anxiety item bank in a cohort of outpatients with IMIDs.MethodsWe selected four items from the Italian standard Short Form Anxiety 8a and administered them to consecutive outpatients affected by Inflammatory Bowel disease (n = 246), rheumatological (n = 100) and dermatological (n = 43) diseases, and healthy volunteers (n = 280). Data was analyzed through an Item Response Theory (IRT) analysis in order to evaluate the psychometric properties of the Italian adaptation of the PROMIS anxiety short form.ResultsTaken together, Confirmatory Factor Analysis and Exploratory Factor analysis suggest that the unidimensionality assumption of the instrument holds. The instrument has excellent reliability from a Classical Theory of Test (CTT) standpoint (Cronbach's α = 0.93, McDonald's ω = 0.92). The 2PL Graded Response Model (GRM) model provided showed a better goodness of fit as compared to the 1PL GRM model, and local independence assumption appears to be met overall. We did not find signs of differential item functioning (DIF) for age and gender, but evidence for uniform (but not non-uniform) DIF was found in three out of four items for the patient vs. control group. Analysis of the test reliability curve suggested that the instrument is most reliable for higher levels of the latent trait of anxiety. The groups of patients exhibited higher levels of anxiety as compared to the control group (ps < 0.001, Bonferroni-corrected). The groups of patients were not different between themselves (p = 1, Bonferroni-corrected). T-scores based on estimated latent trait and raw scores were highly correlated (Pearson's r = 0.98) and led to similar results.DiscussionThe Italian custom four-item short form from the PROMIS anxiety form 8a shows acceptable psychometric properties both from a CTT and an IRT standpoint. The Test Reliability Curve shows that this instrument is mostly informative for people with higher levels of anxiety, making it particularly suitable for clinical populations such as IMID patients.

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.

Dataset Information

Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.

Publications

Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.

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