Prednisone for the prevention of tuberculosis-associated IRIS (randomized controlled trial): Impact on the health-related quality of life

Edwin Wouters; Cari Stek; Alison Swartz; Jozefien Buyze; Charlotte Schutz; Friedrich Thienemann; Robert J Wilkinson; Graeme Meintjes; Lutgarde Lynen; Christiana Nöstlinger

doi:10.3389/fpsyg.2022.983028

Prednisone for the prevention of tuberculosis-associated IRIS (randomized controlled trial): Impact on the health-related quality of life

Front Psychol. 2022 Oct 5:13:983028. doi: 10.3389/fpsyg.2022.983028. eCollection 2022.

Authors

Edwin Wouters^{1

2}, Cari Stek^{3

4}, Alison Swartz⁵, Jozefien Buyze³, Charlotte Schutz^{4

6}, Friedrich Thienemann^{4

6}, Robert J Wilkinson^{7

8}, Graeme Meintjes^{4

6}, Lutgarde Lynen³, Christiana Nöstlinger³

Affiliations

¹ Centre for Population, Family & Health, University of Antwerp, Antwerp, Belgium.
² Centre for Health Systems Research & Development, University of the Free State, Bloemfontein, South Africa.
³ Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
⁴ Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
⁵ Division of Social and Behavioural Sciences, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
⁶ Department of Medicine, University of Cape Town, Cape Town, South Africa.
⁷ Department of Medicine, Imperial College London, London, United Kingdom.
⁸ The Francis Crick Institute, London, United Kingdom.

Abstract

Background: Tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) is an important complication in patients with HIV-associated tuberculosis (TB) starting antiretroviral treatment (ART) in sub-Saharan Africa. The PredART-trial recently showed that prophylactic prednisone reduces the incidence of paradoxical TB-IRIS by 30% in a population at high risk. This paper reports the impact of the intervention on health-related quality of life (HRQoL), a secondary endpoint of the trial, measured by an amended version of the PROQOL-HIV instrument-the instrument's validity and reliability is also assessed.

Methods: A total of 240 adult participants (antiretroviral treatment (ART)-naïve, TB-HIV co-infected with CD4 count ≤100 cells/μL) were recruited and randomized (1:1) to (1) a prednisone arm or (2) a placebo arm. In this sub-study of the PredART-trial we evaluated (1) the performance of an HIV-specific HR-QoL instrument amended for TB-IRIS, i.e., the PROQOL-HIV/TB in patients with HIV-associated TB starting ART (reliability, internal and external construct validity and invariance across time) and (2) the impact of prednisone on self-reported HR-QoL in this population through mixed models.

Results: The PROQOL-HIV/TB scale displayed acceptable internal reliability and good internal and external validity. This instrument, including the factor structure with the eight sub-dimensions, can thus be applied for measuring HR-QoL among HIV-TB patients at high risk for TB-IRIS. Prophylactic prednisone was statistically significantly associated only with the 'Physical Health and Symptoms'-subscale: a four-week course of prednisone resulted in an earlier improvement in the physical dimension of HR-QoL compared to placebo.

Conclusion: We demonstrated that the PROQOL-HIV/TB scale adequately measures different aspects of self-reported HR-QoL in HIV-TB patients. Although more research is needed to understand how other domains related to HR-QoL can be improved, targeting patients at high risk for developing TB-IRIS with a four-week course of prednisone has a beneficial effect on the physical aspects of patient-reported quality of life.

Keywords: South Africa; TB-IRIS; prednisone; quality of life; tuberculosis.