Acceptability of Patient-Reported Outcome and Experience Measures for Hepatitis C Treatment Among People Who Use Drugs
Growing international interest in mechanisms to capture and measure experiences and outcomes of health interventions from the patient perspective has led to the development of patient-reported measures (PRMs) across many areas of medicine. Although PRMs are now well utilised in some settings, the rapidly expanding area of direct-acting antiviral (DAA) treatments for hepatitis C has received remarkably little attention. In addition, questions are also being raised about the extent to which patients have been involved in the development of PRMs, which are primarily designed to reflect the patient perspective. In this context, the aim of this paper was to explore the possibility of developing a new PRM for use in hepatitis C DAA therapy that would also be acceptable to the patient group, in this case people who inject drugs (PWID).
The study was based on a participatory design that included a peer researcher and foundational qualitative research including semi-structured interviews with 24 PWID with hepatitis C to inform the development of the PRMs. Stage 2 included four focus groups of six PWID with hepatitis C, who were asked to complete the draft measures and provide feedback.
Participants responded positively to the draft PRMs. The results indicate that participants’ concerns during DAA treatment are often not sufficiently attended to in clinical settings. In the light of this finding, participants reported that PRMs have a positive role to play in the negotiation of patients’ care during DAA treatment.
The findings show that utilising a participatory approach to the development of PRMs for DAA HCV treatment with PWID not only provides a way to measure experiences and outcomes of treatment from the patient perspective, but also provides a means for highly marginalised patient groups to have a say in and negotiate their care in ways that might not otherwise be possible.
We wish to thank the participants in this study. We are grateful for the support of Harm Reduction Victoria and Hepatitis Victoria. Joanne Neale is part-funded by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. Annie Madden is currently a PhD candidate at the Centre for Social Research in Health and is supported through an Australian Government Research Training Program Scholarship. The Centre for Social Research in Health is supported by a grant from the Australian Government Department of Health. This project was supported by a seed grant from the PLuS Alliance.
CT and JN designed the study. All authors contributed to the data collection tools. AM collected data. MH supervised data collection. AM conducted initial analysis supervised by MH. AM, MH, JN and CT contributed to the draft manuscript. All authors have approved the final article.
Compliance with Ethical Standards
This study was funded by the PLuS Alliance and supported by a grant from the Australian Government Department of Health. Annie Madden, Max Hopwood, Joanne Neale and Carla Treloar have no financial interests to declare. Annie Madden has experience of injecting drug use and of receiving treatment for hepatitis C with direct-acting antiviral therapies and has more than 20 years’ experience as an advocate for the rights of people who inject drugs with local and national peer-based organisations run by and for people who use/have used illicit drugs.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Data availability statement
The datasets generated during the current study are not publicly available given the sensitive nature of the information collected but are available from the corresponding author on reasonable request.
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