{"doi":"10.12688/wellcomeopenres.15412.2","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":"<ns4:p> <ns4:bold>Background:</ns4:bold> 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. </ns4:p> <ns4:p> <ns4:bold>Methods:</ns4:bold> We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Scopus for literature published from 1 <ns4:sup>st</ns4:sup> 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. </ns4:p> <ns4:p> <ns4:bold>Results:</ns4:bold> 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. </ns4:p> <ns4:p> <ns4:bold>Conclusion:</ns4:bold> 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. </ns4:p>","journal":"Wellcome Open Research","year":2020,"id":109866,"datarank":0.31191623125197543,"base_score":2.0794415416798357,"endowment":2.0794415416798357,"self_citation_contribution":0.31191623125197543,"citation_network_contribution":0.0,"self_endowment_contribution":0.31191623125197543,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":7,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9518,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":523814,"name":"Nelson Kalema","orcid":"0000-0002-7118-704X","position":1,"is_corresponding":false},{"id":287967,"name":"Samuel G. Schumacher","orcid":"0000-0002-6136-206X","position":2,"is_corresponding":false},{"id":523815,"name":"Karen R Steingart","orcid":"0000-0002-0422-3522","position":3,"is_corresponding":false},{"id":523816,"name":"Taryn Young","orcid":"0000-0003-2406-081X","position":4,"is_corresponding":false},{"id":523817,"name":"Susan Mallett","orcid":"0000-0002-0596-8200","position":5,"is_corresponding":false},{"id":2313,"name":"Jonathan J. Deeks","orcid":"0000-0002-8850-1971","position":6,"is_corresponding":false},{"id":403919,"name":"Frank Cobelens","orcid":"0000-0002-4367-1133","position":7,"is_corresponding":false},{"id":16495,"name":"Patrick M. Bossuyt","orcid":"0000-0003-4427-0128","position":8,"is_corresponding":false},{"id":242133,"name":"Mark P. Nicol","orcid":"0000-0002-1366-4805","position":9,"is_corresponding":false},{"id":315466,"name":"Adithya Cattamanchi","orcid":"0000-0002-6553-2601","position":10,"is_corresponding":false},{"id":523813,"name":"Eleanor Ochodo","orcid":"0000-0002-7951-3030","position":0,"is_corresponding":true}],"reference_count":32,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-18T23:12:54.309019Z","pmid":"32851196","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}