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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

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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.

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Acknowledgments

The authors thank Martin S. King, PhD, Lois Larsen, PhD, and Wangang Xie, PhD (Department of Statistics, AbbVie, Abbott Park, Illinois) for substantial analytical contributions to the development and validation of the HCV-PRO instrument, and Dana L. Randall, MS, PharmD (Arbor Communications, Inc., Ann Arbor, Michigan) for medical writing support. Mudra Kapoor, MD (AbbVie), is also acknowledged for her medical review of content. The clinical study (M11-602) and the HCV-PRO psychometric analyses were funded in full by AbbVie. Data analyses were completed by Martin S. King, PhD, Lois Larsen, PhD, and Wangang Xie, PhD, who are employees of and received funding from AbbVie. Writing support was provided by Dana L. Randall, MS, PharmD, of Arbor Communications, Inc., Ann Arbor, Michigan, and funded by AbbVie.

Conflict of interests

Robert W Baran and Katherine Gooch are employees of and may own stocks and shares in AbbVie. Birgitta Dietz is an employee of and owns stocks and shares of Abbott GmbH & Co. Dennis A. Revicki has served as a consultant and an advisory board member for AbbVie and has received research funding from AbbVie. Roger T. Anderson and Pennifer Erickson have served as consultants and as advisory board members for AbbVie.

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Authors and Affiliations

  1. Hershey Medical Center, Pennsylvania State University, Hershey, PA, USA

    Roger T. Anderson & Pennifer Erickson

  2. Global Health Economics and Outcomes Research, AbbVie, Abbott Park, IL, USA

    Robert W. Baran & Katherine Gooch

  3. OLGA, State College, PA, USA

    Pennifer Erickson

  4. Outcomes Research, United BioSource Corporation, Bethesda, MD, USA

    Dennis A. Revicki

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

    Birgitta Dietz

  6. Department of Public Health Sciences, College of Medicine, Penn State Milton S. Hershey Medical Center, 600 Centerview Drive, Suite 2200, P.O. Box 855, Hershey, PA, 17033-0855, USA

    Roger T. Anderson

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  1. Roger T. Anderson
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  2. Robert W. Baran
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  4. Dennis A. Revicki
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Correspondence to Roger T. Anderson.

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Anderson, R.T., Baran, R.W., Erickson, P. et al. 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. Qual Life Res 23, 877–886 (2014). https://doi.org/10.1007/s11136-013-0519-1

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  • DOI: https://doi.org/10.1007/s11136-013-0519-1

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