Skip to main content
main-content

Tip

Swipe om te navigeren naar een ander artikel

01-04-2014 | Uitgave 3/2014

Quality of Life Research 3/2014

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

Tijdschrift:
Quality of Life Research > Uitgave 3/2014
Auteurs:
Roger T. Anderson, Robert W. Baran, Pennifer Erickson, Dennis A. Revicki, Birgitta Dietz, Katherine Gooch

Abstract

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.

Log in om toegang te krijgen

Met onderstaand(e) abonnement(en) heeft u direct toegang:

BSL Podotherapeut Totaal

Binnen de bundel kunt u gebruik maken van boeken, tijdschriften, e-learnings, web-tv's en uitlegvideo's. BSL Podotherapeut Totaal is overal toegankelijk; via uw PC, tablet of smartphone.

Literatuur
Over dit artikel

Andere artikelen Uitgave 3/2014

Quality of Life Research 3/2014Naar de uitgave