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Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.

ABSTRACT: BACKGROUND:To better understand symptoms experienced by patients infected with chronic hepatitis C virus (HCV), valid and reliable patient-reported outcome (PRO) measures are needed. AIM:To assess the reliability and validity of 10 patient-reported outcomes measurement information system (PROMIS) measures and the Headache Impact Test-6 (HIT-6) in a large national sample of patients with HCV. METHODS:Pre-treatment data from 961 patients with HCV starting direct acting antiviral therapy at 11 U.S. liver centers were analyzed. Internal reliability was evaluated using Cronbach's alpha coefficient; frequency distributions were examined for floor and ceiling effects; structural validity was investigated via item-response-theory models; convergent validity was evaluated using correlations with theoretically-similar items from the HCV-PRO and memorial symptom assessment scale (MSAS); and known-groups validity was investigated by observing PRO differences by liver disease status and number of comorbidities. RESULTS:The HIT-6 and the majority of the PROMIS measures yielded excellent reliability (alphas ? 0.87). Ceiling effects were infrequent ( < 4%), while 30%-59% of patients reported no symptoms (floor effects). The data supported structural validity of the HIT-6 and most PROMIS measures. The PROMIS measures showed moderate to strong correlations with theoretically-similar items from the HCV-PRO and MSAS (0.39-0.77). Trends were observed between worse PRO scores and advanced cirrhosis and greater number of comorbidities, lending support for known-groups validity. CONCLUSIONS:The psychometric properties of the HIT-6 and PROMIS measures performed satisfactorily in this large cohort of patients with HCV starting direct acting antiviral therapy. Opportunities exist for further refinement of these PROs. Evaluation of performance over time and in under-represented subgroups is needed.

SUBMITTER: Evon DM

PROVIDER: S-EPMC5842131 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.

Evon D M DM Amador J J Stewart P P Reeve B B BB Lok A S AS Sterling R K RK Di Bisceglie A M AM Reau N N Serper M M Sarkar S S Lim J K JK Golin C E CE Fried M W MW

Alimentary pharmacology & therapeutics 20180129 7

<h4>Background</h4>To better understand symptoms experienced by patients infected with chronic hepatitis C virus (HCV), valid and reliable patient-reported outcome (PRO) measures are needed.<h4>Aim</h4>To assess the reliability and validity of 10 patient-reported outcomes measurement information system (PROMIS) measures and the Headache Impact Test-6 (HIT-6) in a large national sample of patients with HCV.<h4>Methods</h4>Pre-treatment data from 961 patients with HCV starting direct acting antivi ...[more]

PMID: 29377191

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Project description:BackgroundEndometriosis 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.ObjectivesThe study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.MethodsIn 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.ResultsThe 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 < 0.0001).ConclusionsPROMIS Fatigue has good reliability, validity, and responsiveness in women with moderate-to-severe endometriosis-associated pain.

Project description:Background & aimsUse of direct-acting oral anticoagulants (DOACs) is increasing, but little is known about the associated risks in patients undergoing colonoscopy with polypectomy. We aimed to determine the risk of post-polypectomy complications in patients prescribed DOACs.MethodsWe performed a retrospective analysis using Optum's de-identified Clinformatics Data Mart Database (2003-2016) (a de-identified administrative database from a large national insurance provider) to identify adults who underwent colonoscopy with polypectomy or endoscopic mucosal resection (EMR) from January 1, 2011, through December 31, 2015. We collected data from 11,504 patients prescribed antithrombotic agents (1590 DOAC, 3471 warfarin, and 6443 clopidogrel) and 599,983 patients not prescribed antithrombotics of interest (controls). We compared 30-day post-polypectomy complications, including gastrointestinal bleeding (GIB), cerebrovascular accident (CVA), myocardial infarction (MI), and hospital admissions, of patients prescribed DOACs, warfarin, or clopidogrel vs controls.ResultsPost-polypectomy complications were uncommon but occurred in a significantly higher proportion of patients receiving any antithrombotic vs controls (P < .001). The percentage of patients in the DOAC group with GIB was 0.63% (95% CI, 0.3%-1.2%) vs 0.2% (95% CI, 0.2%-0.3%) in controls. The percentage of patients with CVA in the DOAC group was 0.06% (95% CI, 0.01%-0.35%) vs 0.04% (95% CI, 0.04%-0.05%) in controls. After we adjusted for bridge anticoagulation, EMR, Charlson comorbidity index (CCI), and CHADS2 (congestive heart failure, hypertension, age over 75, diabetes, stroke [double weight]) score, patients prescribed DOACs no longer had a statistically significant increase in the odds of GIB (odds ratio [OR], 0.90; 95% CI, 0.44-1.85), CVA (OR, 0.45; 95% CI, 0.06-3.28), MI (OR, 1.07; 95% CI, 0.14-7.72), or hospital admission (OR, 0.86; 95% CI, 0.64-1.16). Clopidogrel, warfarin, bridge anticoagulation, higher CHADS2, CCI, and EMR were associated with increased odds of complications.ConclusionIn our retrospective analysis of a large national dataset, we found that patients prescribed DOACs did not have significantly increased adjusted odds of post-polypectomy GIB, MI, CVA, or hospital admission. Bridge anticoagulation, higher CHADS2 score, CCI, and EMR were risk factors for GIB, MI, CVA, and hospital admissions. Studies are needed to determine the optimal peri-procedural dose for high-risk patients.

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.

Project description:IntroductionThe advent of direct-acting antiviral agents for treating hepatitis C virus infection has made hepatitis C virus elimination possible. Rural patients with hepatitis C virus infection may be less likely to access direct-acting antiviral agents, but the real-world evidence is scarce on urban-rural disparities in direct-acting antiviral agent utilization.MethodsThis retrospective cohort study was conducted in 2019-2020 using Medicare data to examine urban-rural disparities in direct-acting antiviral agent utilization among newly diagnosed patients with hepatitis C virus infection in 2014-2016. Direct-acting antiviral agent use was defined as filling ≥1 prescription for direct-acting antiviral agents during 2014-2017, and patient's urban-rural status was classified on the basis of their ZIP code of residence. This study evaluated the associations between multilevel factors and direct-acting antiviral agent use with a focus on urban-rural disparities. It also assessed changes over time in urban-rural disparities in direct-acting antiviral agent utilization using multivariable cause-specific Cox regression analyses with time-varying hazard ratios.ResultsAmong 204,018 new patients with hepatitis C virus infection, about 30% received direct-acting antiviral agents during 2014-2017. Cumulative direct-acting antiviral agent use gradually increased over time in both urban and rural patients. However, the increase was greater in urban patients than in rural patients. In the first year of follow-up, rural patients had a similar rate of receiving direct-acting antiviral agents (adjusted hazard ratio=1.03, 95% CI=1.00, 1.07), but they were less likely to use direct-acting antiviral agents in later years than urban patients (adjusted hazard ratio=0.85, 95% CI=0.81, 0.90 in the second year, adjusted hazard ratio=0.82, 95% CI=0.76, 0.89 in the third year, and adjusted hazard ratio=0.76, 95% CI=0.64, 0.90 in the fourth year of follow-up).ConclusionsThis study reveals important gaps in hepatitis C virus treatment and suggests increasing urban-rural disparities in direct-acting antiviral agent utilization. Enhancing direct-acting antiviral agent uptake in rural populations with hepatitis C virus infection will help reduce hepatitis C virus‒related health disparities and reach the national goal of eliminating hepatitis C virus infection.

Dataset Information

Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.

Publications

Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.

Similar Datasets

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