Abstract
The use of patient-reported outcomes (PROs) to systematically quantify adverse events (AE) will assist in the improvement of medical care and the QoL of patients living with HIV (PLWH). The aim of this study was to investigate the associations between self-reported side effects and other PROs, demographics and laboratory data, and further evaluate the Health Questionnaire (HQ) as a tool for following trends in patient-reported side effects over time in relation to trends in prescribed third agent in ART. The Swedish National Registry InfCareHiv includes an annual self-reported nine-item HQwhich is used in patient-centered HIV care in all Swedish HIV units. In this study, the experience of side effects was addressed. We analyzed 9,476 HQs completed by 4,186 PLWH together with details about their prescribed ART and relevant biomarkers collected during 2011-2017. Data were analyzed using descriptive statistics, Pearson's correlation coefficient and mixed logistic regression. The cross-sectional analysis of the HQs showed that the frequency of reported side effects decreased from 32% (2011) to 15% (2017). During the same period, there was a shift in ART prescription from efavirenz (EFV) to dolutegravir (DTG) (positive correlation coefficient r = 0.94, p = 0.0016). Further, PLWH who reported being satisfied with their physical health (OR: 0.47, p = <0.001) or psychological health (OR: 0.70, p = 0.001) were less likely to report side effects than those less satisfied. Self-reported side effects were found to have a close relationship with the patient's ratings of their overall health situation and demonstrated a strong correlation with the sharp decline in use of EFV and rise in use of DTG, with reported side effects being halved. This study supports the feasibility of using the HQ as a tool for longitudinal follow up of trends in PROs.
Highlights
The use of patient-reported outcomes (PROs) to systematically quantify adverse events (AE) will assist in the improvement of medical care and the quality of life (QoL) of patients living with HIV (PLWH)
The cross-sectional analysis of the Health Questionnaire (HQ) showed that the frequency of reported side effects decreased from 32% (2011) to 15% (2017)
There was a shift in antiretroviral treatment (ART) prescription from efavirenz (EFV) to dolutegravir (DTG)
Summary
The use of patient-reported outcomes (PROs) to systematically quantify adverse events (AE) will assist in the improvement of medical care and the QoL of patients living with HIV (PLWH). The assessment of patient-reported outcomes (PROs) is emerging as an important tool to ensure the long-term health and improvement in quality of life (QoL) of people living with HIV (PLWH) [1]. The use of PROs to improve the treatment and care of PLWH has been found to be a valuable addition to clinicians’ documentation of laboratory data and biomarkers related to adverse events (AE) [2]. It is well known that the reporting of adverse drug reactions (ADRs) by physicians and patients does not always correspond to clinical trial data and several factors may contribute to this discrepancy [4, 5]. Qualitative studies can gain a deeper understanding of patients’ experiences of side-effects [15, 16]
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