International interest has been expressed in the integration of patient-reported outcome measures (PROMs) into human immunodeficiency virus (HIV) care in order to improve the long-term well-being of people living with HIV, with some highlighting the assessment of health-related quality of life and determining symptoms or other possible problems such as social issues and undiagnosed comorbidities.
Standard use of the PROM in HIV clinical care is not a routine practice. For example, in Canada, the host of the present project, the team was aware of a few published studies, including the PROgress study at a Toronto site and the team’s pilot study in Montreal. The targeted outcomes can vary internationally, across initiatives. For example, among the many PROs captured from the QuaLiv (France), PROgress (USA, Canada), Positive Outcomes (UK), and AmbuFlex PRO system projects (Denmark), the only common outcomes like alcohol use, drug use, and symptoms of depression emerge. As a result, PROs are emphasized and crucial for uptake in these HIV care settings, which may be driven by local considerations and needs.
PROMs represent tools to capture direct, unfiltered patient reports on their perspective on health (questionnaires). Evidence is found for the highly acceptable and valuable use of PROM in HIV clinical practice by both patients and providers, with likely benefits including improved patient-provider communication, priority setting during consultations, and detection and monitoring of health issues.
Core outcome sets (COS) have been developed for clinical practice use. A core outcome set (COS) is a standardized collection of agreed-on outcomes for a medical condition, treatment, or intervention that should at least be measured and reported, in clinical trials.
Adults living with HIV (18 years or older) would be the proposed COS development pathway using routine use in HIV clinical practice settings. The main application of the COS is to support clinical patient management at the individual level. It will be used primarily for screening and monitoring the selected outcomes. With stakeholders (performance evaluation, healthcare planning, quality improvement, and patient-oriented research), the possible use of COS at the aggregate level will be discussed.
This evidence-based COS development will take place in 2 phases: core outcome measures in effectiveness trials (COMET) initiative the COS standards for development recommendations and the COS-standardised protocol items statement.
In step 2, there will be a questionnaire for stakeholders with a revised Delphi to grade essential and peripheral PROs from the finalized list of PROs (from step 1). Differences are expected and the Delphi will have two comparison panels (one of people with HIV and the other of providers). Participating in private and public HIV healthcare settings in Montreal are using flyers, email invitations, and word-of-mouth to recruit Panellists. Two rounds of online surveys were carried out using research electronic data capture (REDCap).
Given COMET-COSMIN guidance, content validity, internal structure, and other measurement properties will be collected and considered in the order of psychometric properties, prioritizing content validity followed by internal structure and then other measurement properties. These are compared with feasibility factors in the phase 1 Delphi (for example respondent preference for several questions in the core set, patient completion time, and time spent by health care professionals for review of results). Additionally, the team will search the literature to find evidence of candidate instrument implementation and effectiveness in clinical practice, for further consideration.
The Research Ethics Board at the Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada (reference #2024-9695), approved this project on 9 December 2024. In phase 2 the focus will primarily be on knowledge translation between the instrument selection and traditional channels, such as national and international conferences and peer-reviewed journals.
Reference: Engler K, Lessard D, Lacombe K, Palich R, Lebouché B. Development of a core patient-reported outcome set for use in HIV care at the individual patient level in Montreal: protocol for a two-phased multimethod project. BMJ Open. 2025;15(1):e088822. doi:10.1136/bmjopen-2024-088822
