Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment

Donna M. Evon, Carol E. Golin, Paul Stewart, Michael W. Fried, Shani Alston, Bryce Reeve, Anna S. Lok, Richard K. Sterling, Joseph K. Lim, Nancy Reau, Souvik Sarkar, David R. Nelson, K. R. Reddy, Adrian M. Di Bisceglie

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

Background New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed. Methods PROP UP is a multi-center prospective observational study that plans to enroll 1600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12 weeks post-treatment (T4), 12 months post-treatment (T5). Outcomes (1) Changes in side effects, functioning, pre-existing conditions, and out-of-pocket costs during therapy (T1 vs T2/T3); (2) Medication adherence in relation to a history of mental health/substance abuse, treatment regimens, pill burden, reasons for missed doses, and cure rates; (3) Short term impact of cure on functioning and amelioration of symptoms (T1 vs T4); (4) Long-term treatment harms or benefits of cure on symptoms, side effects, pre-existing conditions, and functioning (T1 vs T5). Similarities between regimens will be examined where comparisons are appropriate and meaningful. Conclusion PROP UP complements previous clinical trials by focusing on patient-reported outcomes in a representative sample of patients treated in clinical practice, by collaborating with a patient engagement group, by characterizing the experiences of vulnerable subgroups, and by investigating long-term harms and benefits of treatments. PROP UP is designed to provide novel and detailed information to support informed decision-making for patients and providers contemplating HCV treatment (PCORI CER-1408-20,660; NCT02601820).

Original languageEnglish (US)
Pages (from-to)58-68
Number of pages11
JournalContemporary Clinical Trials
Volume57
DOIs
StatePublished - Jun 1 2017

Keywords

  • Direct acting antiviral (DAA)
  • Hepatitis
  • Liver
  • Patient-centered outcomes research (PCOR)
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

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    Evon, D. M., Golin, C. E., Stewart, P., Fried, M. W., Alston, S., Reeve, B., Lok, A. S., Sterling, R. K., Lim, J. K., Reau, N., Sarkar, S., Nelson, D. R., Reddy, K. R., & Di Bisceglie, A. M. (2017). Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment. Contemporary Clinical Trials, 57, 58-68. https://doi.org/10.1016/j.cct.2017.03.013