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Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment
- Source :
- Contemporary clinical trials. 57
- Publication Year :
- 2016
-
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 ).
- Subjects :
- Male
Comparative Effectiveness Research
Pyrrolidines
Sofosbuvir
Medical and Health Sciences
Hepatitis
Substance Misuse
0302 clinical medicine
Heterocyclic Compounds
Patient-Centered Care
Pharmacology (medical)
030212 general & internal medicine
Prospective Studies
Chronic
Prospective cohort study
General Clinical Medicine
Sulfonamides
Liver Disease
Imidazoles
Patient-centered outcomes research
Valine
General Medicine
Hepatitis C
Substance abuse
Drug Combinations
Infectious Diseases
Treatment Outcome
Liver
030211 gastroenterology & hepatology
Female
Public Health
Uridine Monophosphate
medicine.drug
Adult
medicine.medical_specialty
Macrocyclic Compounds
Chronic Liver Disease and Cirrhosis
Clinical Trials and Supportive Activities
Antiviral Agents
Heterocyclic Compounds, 4 or More Rings
Article
03 medical and health sciences
Hepatitis - C
Clinical Research
Quinoxalines
Behavioral and Social Science
medicine
Humans
Patient participation
Intensive care medicine
Uracil
Benzofurans
Fluorenes
Patient-reported outcomes
Ritonavir
business.industry
4 or More Rings
Hepatitis C, Chronic
medicine.disease
Clinical trial
Emerging Infectious Diseases
Good Health and Well Being
Physical therapy
Observational study
Direct acting antiviral
Benzimidazoles
Carbamates
Patient Participation
business
Digestive Diseases
Drug Abuse (NIDA only)
Subjects
Details
- ISSN :
- 15592030
- Volume :
- 57
- Database :
- OpenAIRE
- Journal :
- Contemporary clinical trials
- Accession number :
- edsair.doi.dedup.....6b65abb363b22a9b1360acaae801ea4d