Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality: a systematic review and analysis of trial design considerations

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Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality : a systematic review and analysis of trial design considerations. / Ochodo, Eleanor A.; Kalema, Nelson ; Schumacher, Samuel ; Steingart, Karen R.; Young, Taryn; Mallett, Sue; Deeks, Jon; Cobelens, Frank ; Bossuyt, Patrick M.; Nicol, Mark P; Cattamanchi, Adithya .

In: Wellcome Open Research, Vol. 4, 173, 17.08.2020.

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Ochodo, Eleanor A. ; Kalema, Nelson ; Schumacher, Samuel ; Steingart, Karen R. ; Young, Taryn ; Mallett, Sue ; Deeks, Jon ; Cobelens, Frank ; Bossuyt, Patrick M. ; Nicol, Mark P ; Cattamanchi, Adithya . / Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality : a systematic review and analysis of trial design considerations. In: Wellcome Open Research. 2020 ; Vol. 4.

Bibtex

@article{c5c05b89841449e3b7aa438fba443f20,
title = "Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality: a systematic review and analysis of trial design considerations",
abstract = "Background:Most studies evaluating the effect of Xpert MTB/RIF testing for tuberculosis (TB) concluded that it did not reduce overall mortality compared to usual care. We conducted a systematic review to assess whether key study design and execution features contributed to earlier identification of patients with TB and decreased pre-treatment loss to follow-up, thereby reducing the potential impact of Xpert MTB/RIF testing.Methods:We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Scopus for literature published from 1 January 2009 to February 2019. We included all primary intervention studies that had evaluated the effect of Xpert MTB/RIF on mortality compared to usual care in participants with presumptive pulmonary TB. We critically reviewed features of included studies across: Study setting and context, Study population, Participant recruitment and enrolment, Study procedures, and Study follow-up.Results:We included seven randomised and one non-randomised study. All included studies demonstrated relative reductions in overall mortality in the Xpert MTB/RIF arm ranging from 6% to 40%. However, mortality reduction was reported to be statistically significant in two studies. Study features that could explain the lack of observed effect on mortality included: the higher quality of care at study sites; inclusion of patients with a higher pre-test probability of TB leading to higher than expected empirical rates; performance of additional diagnostic testing not done in usual care leading to increased TB diagnosis or empiric treatment initiation; the recruitment of participants likely to return for follow-up; and involvement of study staff in ensuring adherence with care and follow-up.Conclusion:Most studies of Xpert MTB/RIF were designed and conducted in a manner that resulted in more patients being diagnosed and treated for TB, minimising the potential difference in mortality Xpert MTB/RIF testing could have achieved compared to usual care.",
keywords = "Tuberculosis diagnosis, Methodology, Diagnostic trials, Impact studies",
author = "Ochodo, {Eleanor A.} and Nelson Kalema and Samuel Schumacher and Steingart, {Karen R.} and Taryn Young and Sue Mallett and Jon Deeks and Frank Cobelens and Bossuyt, {Patrick M.} and Nicol, {Mark P} and Adithya Cattamanchi",
year = "2020",
month = aug,
day = "17",
doi = "10.12688/wellcomeopenres.15412.2",
language = "English",
volume = "4",
journal = "Wellcome Open Research",
issn = "2398-502X",
publisher = "Wellcome Trust",

}

RIS

TY - JOUR

T1 - Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality

T2 - a systematic review and analysis of trial design considerations

AU - Ochodo, Eleanor A.

AU - Kalema, Nelson

AU - Schumacher, Samuel

AU - Steingart, Karen R.

AU - Young, Taryn

AU - Mallett, Sue

AU - Deeks, Jon

AU - Cobelens, Frank

AU - Bossuyt, Patrick M.

AU - Nicol, Mark P

AU - Cattamanchi, Adithya

PY - 2020/8/17

Y1 - 2020/8/17

N2 - Background:Most studies evaluating the effect of Xpert MTB/RIF testing for tuberculosis (TB) concluded that it did not reduce overall mortality compared to usual care. We conducted a systematic review to assess whether key study design and execution features contributed to earlier identification of patients with TB and decreased pre-treatment loss to follow-up, thereby reducing the potential impact of Xpert MTB/RIF testing.Methods:We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Scopus for literature published from 1 January 2009 to February 2019. We included all primary intervention studies that had evaluated the effect of Xpert MTB/RIF on mortality compared to usual care in participants with presumptive pulmonary TB. We critically reviewed features of included studies across: Study setting and context, Study population, Participant recruitment and enrolment, Study procedures, and Study follow-up.Results:We included seven randomised and one non-randomised study. All included studies demonstrated relative reductions in overall mortality in the Xpert MTB/RIF arm ranging from 6% to 40%. However, mortality reduction was reported to be statistically significant in two studies. Study features that could explain the lack of observed effect on mortality included: the higher quality of care at study sites; inclusion of patients with a higher pre-test probability of TB leading to higher than expected empirical rates; performance of additional diagnostic testing not done in usual care leading to increased TB diagnosis or empiric treatment initiation; the recruitment of participants likely to return for follow-up; and involvement of study staff in ensuring adherence with care and follow-up.Conclusion:Most studies of Xpert MTB/RIF were designed and conducted in a manner that resulted in more patients being diagnosed and treated for TB, minimising the potential difference in mortality Xpert MTB/RIF testing could have achieved compared to usual care.

AB - Background:Most studies evaluating the effect of Xpert MTB/RIF testing for tuberculosis (TB) concluded that it did not reduce overall mortality compared to usual care. We conducted a systematic review to assess whether key study design and execution features contributed to earlier identification of patients with TB and decreased pre-treatment loss to follow-up, thereby reducing the potential impact of Xpert MTB/RIF testing.Methods:We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Scopus for literature published from 1 January 2009 to February 2019. We included all primary intervention studies that had evaluated the effect of Xpert MTB/RIF on mortality compared to usual care in participants with presumptive pulmonary TB. We critically reviewed features of included studies across: Study setting and context, Study population, Participant recruitment and enrolment, Study procedures, and Study follow-up.Results:We included seven randomised and one non-randomised study. All included studies demonstrated relative reductions in overall mortality in the Xpert MTB/RIF arm ranging from 6% to 40%. However, mortality reduction was reported to be statistically significant in two studies. Study features that could explain the lack of observed effect on mortality included: the higher quality of care at study sites; inclusion of patients with a higher pre-test probability of TB leading to higher than expected empirical rates; performance of additional diagnostic testing not done in usual care leading to increased TB diagnosis or empiric treatment initiation; the recruitment of participants likely to return for follow-up; and involvement of study staff in ensuring adherence with care and follow-up.Conclusion:Most studies of Xpert MTB/RIF were designed and conducted in a manner that resulted in more patients being diagnosed and treated for TB, minimising the potential difference in mortality Xpert MTB/RIF testing could have achieved compared to usual care.

KW - Tuberculosis diagnosis

KW - Methodology

KW - Diagnostic trials

KW - Impact studies

U2 - 10.12688/wellcomeopenres.15412.2

DO - 10.12688/wellcomeopenres.15412.2

M3 - Article

VL - 4

JO - Wellcome Open Research

JF - Wellcome Open Research

SN - 2398-502X

M1 - 173

ER -