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

Wellcome Open Research

article

Eleanor A. Ochodo¹  Nelson Kalema²  Samuel Schumacher³  Karen Steingart⁴  Taryn Young¹  Susan Mallett⁵  Jon Deeks⁵  Frank Cobelens⁷  Patrick M. Bossuyt⁸  Mark P. Nicol⁹  Adithya Cattamanchi^1,10 

[1] Department of Global Health, Stellenbosch University;Infectious Diseases Institute, Makerere University;Tuberculosis Department, Foundation for Innovative New Diagnostics;Department of Clinical Sciences, Liverpool School of Tropical Medicine;NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Trust, University of Birmingham;Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham;Amsterdam Institute for Global Health and Development, Amsterdam University Medical Centers;Deapartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers;School of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Western Australia;Division of Pulmonary and Critical Care Medicine, University of California San Francisco Medical Center

关键词: Tuberculosis diagnosis;    methodology;    Diagnostic trials;    Impact studies;   

DOI  :  10.12688/wellcomeopenres.15412.2

学科分类：内科医学

来源: Wellcome

【 摘 要 】

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 1st 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.

【 授权许可】

CC BY