Evidence map›Paper›PMID 33143704›Full record

ArticleBMC medicine2020

Investigation of the efficacy of the short regimen for rifampicin-resistant TB from the STREAM trial.

P P J Phillips, A Van Deun, S Ahmed, R L Goodall, S K Meredith, F Conradie, C-Y Chiang, I D Rusen, A J Nunn

Abstract read
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In one paragraph

Article in BMC medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Failure or relapse predictors for the STREAM Stage 1 short regimen for RR-TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022
    Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

P P J PhillipsUCSF Center for Tuberculosis, University of California San Francisco, San Francisco, USA. Patrick.phillips@ucsf.edu.
A Van Deun, Leuven, Belgium.
S AhmedMRC Clinical Trials Unit at UCL, London, UK.
R L GoodallMRC Clinical Trials Unit at UCL, London, UK.
S K MeredithMRC Clinical Trials Unit at UCL, London, UK.
F ConradieFaculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
C-Y ChiangDivision of Pulmonary Medicine, Department of Internal Medicine, Wanfang Hospital, Taipei Medical University, Taipei, Taiwan.
I D RusenResearch Division, Vital Strategies, New York, USA.
A J NunnMRC Clinical Trials Unit at UCL, London, UK.

Funding

Medical Research Council MC_EX_UU_MR/J012513/1Medical Research Council MC_U122888469Medical Research Council MC_UU_12023/26Medical Research Council MR/J012513/1
6 · The paper itself

Abstract

backgroundThe STREAM trial demonstrated that a 9-11-month "short" regimen had non-inferior efficacy and comparable safety to a 20+ month "long" regimen for the treatment of rifampicin-resistant tuberculosis. Imbalance in the components of the composite primary outcome merited further investigation.

methodsFirstly, the STREAM primary outcomes were mapped to alternatives in current use, including WHO programmatic outcome definitions and other recently proposed modifications for programmatic or research purposes. Secondly, the outcomes were re-classified according to the likelihood that it was a Failure or Relapse (FoR) event on a 5-point Likert scale: Definite, Probable, Possible, Unlikely, and Highly Unlikely. Sensitivity analyses were employed to explore the impact of informative censoring. The protocol-defined modified intention-to-treat (MITT) analysis population was used for all analyses.

resultsCure on the short regimen ranged from 75.1 to 84.2% across five alternative outcomes. However, between-regimens results did not exceed 1.3% in favor of the long regimen (95% CI upper bound 10.1%), similar to the primary efficacy results from the trial. Considering only Definite or Probable FoR events, there was weak evidence of a higher risk of FoR in the short regimen, HR 2.19 (95%CI 0.90, 5.35), p = 0.076; considering only Definite FoR events, the evidence was stronger, HR 3.53 (95%CI 1.05, 11.87), p = 0.030. Cumulative number of grade 3-4 AEs was the strongest predictor of censoring. Considering a larger effect of informative censoring attenuated treatment differences, although 95% CI were very wide.

conclusionFive alternative outcome definitions gave similar overall results. The risk of failure or relapse (FoR) may be higher in the short regimen than in the long regimen, highlighting the importance of how loss to follow-up and other censoring is accounted for in analyses. The outcome of time to FoR should be considered as a primary outcome for future drug-sensitive and drug-resistant TB treatment trials, provided sensitivity analyses exploring the impact of departures from independent censoring are also included.

Indexed as

Antitubercular AgentsHumansRifampinTreatment OutcomeTuberculosis, Multidrug-ResistantAntitubercular AgentsRifampinCausal inferenceInverse probability of censoring weightingMDR-TBMultiple imputationNon-inferiorityShort regimenTuberculosis

Identifiers

PMID33143704
PMCPMC7640464

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.