Introduction
There is international interest in using patient-reported outcome measures (PROMs) in HIV care to improve the long-term wellbeing of people living with HIV (PLHIV). However, it is less clear which patient-reported outcomes and measures to prioritize for this purpose, particularly given possible differences in stakeholder perspectives. The objective of this project is to engage both PLHIV and healthcare, social and community service providers to develop a core set of patient-reported outcomes and measures for use in individual HIV patient care in Montreal (Canada) and Paris (France), distinguishing between essential and peripheral outcomes.
Methods and analysis
This multi-method project will follow guidance documents of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and be conducted in two phases. Phase 1 will see the selection of the core set of outcomes (i.e., the health concepts to target) and involve a rapid scoping review (manuscript under review) to inform a Delphi study with a panel of 100 PLHIV and providers in Montreal and Paris. It will end with a multidisciplinary consensus meeting during which participants will discuss and vote on inconclusive outcomes to make final decisions. Phase 2 will be devoted to choosing the measures to assess the selected outcomes. It will involve a systematic search for instruments, an appraisal of the quality and feasibility of the identified instruments, and a consensus meeting for the final selection.
Justification
We are aware of only one published COS applicable to high income countries for use in HIV, the HIV360. Designed for the clinical care of adults with HIV worldwide and emphasizing its use for aggregate-level analyses, it includes a mix of patient-, clinician-, and administratively- reported outcomes. Its PROs are health-related quality of life, depression, and sexual health (function and engagement with testing for sexually transmitted infections). To our knowledge, no COS has yet been designed precisely to prioritize and standardize PROs to feed individual patient data back to HIV healthcare providers to inform patient management. Furthermore, given: 1) the diversity of PROM data used in individual HIV patient care across published initiatives, with a disproportionate measurement of mental health and substance use, and to a lesser extent, self-management (e.g., adherence) and symptoms (manuscript under review); 2) the possibility of measuring a wide variety of patient-reported outcomes efficiently; 3) the potential for patient-provider differences in PRO prioritization for HIV care, as evidenced by past research on outcome preferences, for instance, and the interest of transparently accounting for these in COS development; and 4) the similarities in HIV care, patient characteristics, and the official language in Montreal and Paris (French); we feel a new PROM-specific COS for HIV care in these cities is justified. (Note that this COS will be developed simultaneously in both French and English).
Core members of the research team:
Kim Engler PhD (Principal investigator), Center for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
Bertrand Lebouché, MD, PhD (Principal investigator), Department of Family Medicine, McGill University; Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada.
Karine Lacombe, MD (Principal investigator), Sorbonne Université, Infectious and Tropical Disease Department, Saint-Antoine Hospital, Pierre Louis Epidemiology and Public Health institute (iPLESP), INSERM UMR-S1136, Paris, France.
David Lessard, PhD (Co-investigator), Center for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
Romain Palich, MD (Co-investigator), Sorbonne University, Infectious Diseases Department, Pitié-Salpêtrière Hospital, AP-HP, Pierre Louis Epidemiology and Public Health institute (iPLESP), INSERM UMR-S 1136, Paris, France.
Hayette Rougier (Co-investigator), Saint-Antoine Hospital, Paris, France.
Disease Category: Infectious disease
Disease Name: HIV/AIDS
Age Range: 18
Sex: Either
Nature of Intervention: Procedure
- Clinical experts
- Methodologists
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Statisticians
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Survey
- Systematic review
This multi-method study will follow guidance documents of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and be conducted in two phases. Phase 1 will see the selection of the core set of outcomes (i.e., the health concepts to target) and involve a rapid scoping review (manuscript under review) to inform a Delphi study with a panel of 100 PLHIV and providers in Montreal and Paris. It will end with a multidisciplinary consensus meeting during which participants will discuss and vote on inconclusive outcomes to make final decisions. Phase 2 will be devoted to choosing the measures to assess the selected outcomes. It will involve a systematic search for instruments, an appraisal of the quality and feasibility of the identified instruments, and a consensus meeting for the final selection.