@article{Wouters2022,
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)-na{\"{i}}ve, TB-HIV co-infected with CD4 count ≤100 cells/$\mu$L) 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.},
author = {Wouters, Edwin and Stek, Cari and Swartz, Alison and Buyze, Jozefien and Schutz, Charlotte and Thienemann, Friedrich and Wilkinson, Robert J and Meintjes, Graeme A and Lynen, Lutgarde and N{\"{o}}stlinger, Christiana},
doi = {10.3389/FPSYG.2022.983028},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Wouters et al. - 2022 - Prednisone for the prevention of tuberculosis-associated IRIS (randomized controlled trial) Impact on the health.pdf:pdf},
issn = {16641078},
journal = {Frontiers in Psychology},
keywords = {OA,South Africa,TB-IRIS,fund{\_}ack,original,prednisone,quality of life,tuberculosis},
mendeley-tags = {OA,fund{\_}ack,original},
month = {oct},
pages = {983028},
pmid = {36275235},
publisher = {Frontiers Media S.A.},
title = {{Prednisone for the prevention of tuberculosis-associated IRIS (randomized controlled trial): Impact on the health-related quality of life}},
url = {https://www.frontiersin.org/articles/10.3389/fpsyg.2022.983028/full},
volume = {13},
year = {2022}
}

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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/$μ$L) 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.","author":[{"propositions":[],"lastnames":["Wouters"],"firstnames":["Edwin"],"suffixes":[]},{"propositions":[],"lastnames":["Stek"],"firstnames":["Cari"],"suffixes":[]},{"propositions":[],"lastnames":["Swartz"],"firstnames":["Alison"],"suffixes":[]},{"propositions":[],"lastnames":["Buyze"],"firstnames":["Jozefien"],"suffixes":[]},{"propositions":[],"lastnames":["Schutz"],"firstnames":["Charlotte"],"suffixes":[]},{"propositions":[],"lastnames":["Thienemann"],"firstnames":["Friedrich"],"suffixes":[]},{"propositions":[],"lastnames":["Wilkinson"],"firstnames":["Robert","J"],"suffixes":[]},{"propositions":[],"lastnames":["Meintjes"],"firstnames":["Graeme","A"],"suffixes":[]},{"propositions":[],"lastnames":["Lynen"],"firstnames":["Lutgarde"],"suffixes":[]},{"propositions":[],"lastnames":["Nöstlinger"],"firstnames":["Christiana"],"suffixes":[]}],"doi":"10.3389/FPSYG.2022.983028","file":":C$\\$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Wouters et al. - 2022 - Prednisone for the prevention of tuberculosis-associated IRIS (randomized controlled trial) Impact on the health.pdf:pdf","issn":"16641078","journal":"Frontiers in Psychology","keywords":"OA,South Africa,TB-IRIS,fund_ack,original,prednisone,quality of life,tuberculosis","mendeley-tags":"OA,fund_ack,original","month":"oct","pages":"983028","pmid":"36275235","publisher":"Frontiers Media S.A.","title":"Prednisone for the prevention of tuberculosis-associated IRIS (randomized controlled trial): Impact on the health-related quality of life","url":"https://www.frontiersin.org/articles/10.3389/fpsyg.2022.983028/full","volume":"13","year":"2022","bibtex":"@article{Wouters2022,\r\nabstract = {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)-na{\\\"{i}}ve, TB-HIV co-infected with CD4 count ≤100 cells/$\\mu$L) were recruited and randomized (1:1) to (1) a prednisone arm or (2) a placebo arm. 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