Patient-reported outcomes in HIV clinical trials evaluating antiretroviral treatment: a systematic review

ABSTRACT

We aimed to assess patterns of patient-reported outcomes (PRO) instruments’ utilization in HIV clinical trials in relation to antiretroviral therapy (ART). PubMed/MEDLINE, Scopus, and EMBASE were searched using the terms “Patient-Reported Outcomes” and “HIV/AIDS” or “Antiretroviral Treatment” or “ART” or “Antiretroviral Therapy” from 1 January 1990 until 1 December 2019. In total, 173 studies were identified and 26 were directly related to ART. Study population included treatment-naïve patients (n = 4), treatment-experienced (n = 20), or both (n = 2). Instruments were implemented to assess general experience with ART (n = 3), single-tablet regimens (STR) (n = 2), monotherapy (n = 4), regimen switch (n = 9), or regimen comparison (n = 8). The most commonly used instruments were Medical Outcomes Study-HIV Health Survey (MOS–HIV, n = 8), HIV Symptom Index (HIV-SI, n = 7) and unstructured self-reports (n = 5) followed by others. MOS–HIV was used mainly in comparative (n = 4) and monotherapy (n = 3) trials, HIV-SI in switch (n = 4) and STR (n = 2) trials, and self-reports in comparative trials (n = 3). Even though, the implementation of PRO tools is increasing with time, reporting of PRO in HIV clinical trials remains limited.

KEYWORDS:

• Patient-reported outcomes
• antiretroviral therapy
• HIV

Acknowledgements

The present study was conducted in the context of the production of educational material on PRO for Gilead Sciences Hellas.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work was supported by Gilead Sciences Hellas [grant number 80735].