Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: Validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

AndersonR.T.; BaranR.W.; EricksonP.RevickiD.A.DietzB.GoochK.

首页> 外文期刊>Quality of life research: An international journal of quality of life aspects of treatment, care and rehabilitation >Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: Validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

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Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: Validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

机译：Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: Validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

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Purpose: To describe the psychometric properties and identify the minimally important difference (MID) of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument. Chronic HCV infection and associated treatments negatively affect PROs of function and well-being. Methods: In a phase 2 trial, HCV-infected patients received direct-acting antivirals (DAAs) for 12 weeks with peg-interferon/ribavirin (peg-IFN/RBV) for 48 weeks, or placebo plus peg-IFN/RBV. The HCV-PRO total score, SF-36 PCS and MCS scores, EQ-5D-3L, and EQ VAS were measured at baseline, week 8, end of DAA treatment (EODT), end of peg-IFN/RBV treatment (EOT), and posttreatment week 24 (SVR24). Convergent validity of the HCV-PRO was assessed by Pearson's correlation coefficients. Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores (none vs. some) and presence/absence of depression or fatigue adverse events. MID was identified through effect size (ES) and receiver-operating characteristic (ROC) curve analyses (HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds). Results: In 74 patients (22 female; 81 White; 51 ≤50 years), correlations (0.64-0.96) between HCV-PRO total scores, SF-36 PCS/MCS scores, and EQ VAS scores at all time points supported convergent validity. HCV-PRO total scores were reduced to 10-30 points in patients impaired by depression, pain, or fatigue symptoms. Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time (EODT -0.76; EOT -0.93). ES and ROC curve analyses indicated an MID of -10 points. Conclusion: The HCV-PRO was valid and responsive in the population studied. An MID of -10 points represented a threshold of clinical significance for the HCV-PRO.

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《Quality of life research: An international journal of quality of life aspects of treatment, care and rehabilitation》 |2014年第3期|877-886|共10页
作者
AndersonR.T.; BaranR.W.; EricksonP.RevickiD.A.DietzB.GoochK.;
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作者单位

Outcomes Research, United BioSource Corporation, Bethesda, MD, United States;

AbbVie Deutschland GmbH and Co., Ludwigshafen am Rhein, Germany;

Global Health Economics and Outcomes Research, AbbVie, Abbott Park, IL, United StatesHershey Medical Center, Pennsylvania State University, Hershey, PA, United States, Department ofHershey Medical Center, Pennsylvania State University, Hershey, PA, United States, OLGA, State;

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正文语种英语
中图分类医药、卫生;
关键词
Health status; Psychometric methods; Quality of life; Questionnaires;

Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: Validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

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