Oral Regimens for Rifampin-Resistant, Fluoroquinolone-Susceptible Tuberculosis.
Guglielmetti L, Khan U, Velásquez GE, Gouillou M, Abubakirov A, Baudin E, Berikova E, Berry C, Bonnet M, Cellamare M, Chavan V, Cox V, Dakenova Z, de Jong BC, Ferlazzo G, Karabayev A, Kirakosyan O, Kiria N, Kunda M, Lachenal N, Lecca L, McIlleron H, Motta I, Toscano SM, Mushtaque H, Nahid P, Oyewusi L, Panda S, Patil S, Phillips PPJ, Ruiz J, Salahuddin N, Garavito ES, Seung KJ, Ticona E, Trippa L, Vasquez DEV, Wasserman S, Rich ML, Varaine F, Mitnick CD, endTB Clinical Trial Team
Paper source
Oral Regimens for Rifampin-Resistant, Fluoroquinolone-Susceptible Tuberculosis.
This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026
How this rating was calculated▸
- IntegrityIntegrity concern−0.5★
- ReportingData & code availability partially met−0.25★
- Data/code availability incomplete
- Internal contradictions in the reported numbers
This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This paper presents a rigorously designed Phase III randomized trial with strong reporting transparency, ethical approvals, and biological variable reporting. However, it has notable gaps in three dimensions: the open-label design and incomplete power analysis (study design), inconsistent exact p-value reporting and absent multiplicity adjustment (statistical analysis), and a vague data/code availability statement (data_code_availability).
All eight dimensions were applicable. Reviewers agreed on 6 of 8 dimensions (scientific premise, biological variables, ethical approvals, key resources, data code availability, reporting transparency). Two dimensions (study design, statistical analysis) had minor divergences resolved by weighing the combined evidence. No replication or reproducibility checks were possible beyond link verification.
12 major claims checked against the paper's own evidence: all adequately supported.
Recomputed 1 test: 1 consistent, 0 inconsistent, 1 via agent-written checks.
1 integrity concern flagged (0 high).
16 copyedit issues flagged: mostly consistency, clarity, punctuation.
Checked 38 references: 31 verified — 7 not checked.
2 data/code links checked; 2 live.
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Ready for submission after minor to moderate revisions. The three warn-dimension issues (open-label limitations; p-value reporting and multiplicity; data/code availability) are straightforward to address and do not undermine the study's core conclusions. Authors should prioritize the data availability statement, as this is increasingly a journal requirement.
- 1.HIGHdata codeAdd an explicit data availability statement specifying the repository/platform (e.g., ClinicalStudyDataRequest, Vivli, or an institutional data access committee) and conditions for access, including a timeframe for response.The current 'available on reasonable request' statement is vague and fails current journal standards; a concrete pathway is expected for data-driven publications.
- 2.HIGHstatisticsReport exact p-values (e.g., p=0.032, not p<0.05) for all primary and key secondary efficacy comparisons, or explain why confidence intervals alone suffice per the non-inferiority framework.Two reviewers flagged inconsistent p-value reporting; exact values improve transparency and allow readers to assess evidence strength.
- 3.HIGHstatisticsExplicitly state how multiplicity across the five experimental arms was handled (e.g., hierarchical testing, Bonferroni correction, or a statement that no adjustment was made and why).Multiple comparisons without adjustment inflate Type I error; the current footnote in Table 2 does not provide a justification for the approach.
- 4.HIGHrigorIn the Discussion, expand the justification for the open-label design beyond 'treatment-duration difference' to discuss specific measures taken to mitigate bias (e.g., blinded central outcome adjudication, concealment from laboratory staff).Two reviewers considered the blinding rationale insufficient; stronger justification enhances reader confidence in results despite the open-label design.
- 5.HIGHrigorClarify in the Statistical Methods section whether the power analysis covers all five experimental arms or only a subset, and if only a subset, acknowledge the implications for the non-covered arms.The power analysis explicitly covers only 3 of 5 regimens in mITT and 2 in PP; readers need to understand which comparisons are adequately powered.
- 6.HIGHstatisticsVerify and report the proportional hazards assumption for each Cox regression comparison individually (not just globally), or note if it was not tested for each.Schoenfeld residuals are mentioned but it is unclear whether they were applied per-regimen; assumption violations can bias hazard ratio estimates.
- 7.MEDIUMdata codeDeposit the Stata analysis code (e.g., .do files) in a public repository such as GitHub or Zenodo with a persistent identifier, even if patient-level data cannot be shared.Code sharing enhances reproducibility; it is independent of data sharing and is increasingly expected by journals.
- 8.MEDIUMreportingAdd a brief statement in the Statistical Methods about how missing data were handled in the primary analysis (e.g., complete-case analysis, multiple imputation).Missing data handling is a key methodological detail that is currently absent; its omission may raise reviewer questions.
- 9.MEDIUMcopyeditAdd a comma after 'week 73' in the Abstract: '... favorable outcome at week 73, defined by ...'Missing comma before 'defined' causes a minor clarity issue in the primary outcome definition.
- 10.MEDIUMcopyeditIn the Safety Results, add a comma after 'respectively': '... 54/174 (31.0%), respectively, were classified ...'Missing comma creates an awkward reading; punctuation fix ensures clarity.
- 11.MEDIUMcopyeditCapitalize 'Eastern Cooperative Oncology Group' consistently in Table 1 footnotes.Minor capitalization inconsistency as flagged by copyedit.
- 12.LOWreportingConsider specifying the years or versions of the WHO guidelines that changed during enrollment in the Discussion.Providing guideline version details adds context for readers tracking evolving standards.
- 13.LOWcopyeditRephrase 'for at least rifampin and fluoroquinolones' in Methods for clarity (e.g., 'for rifampin and fluoroquinolones, at a minimum').The current phrasing is grammatically awkward and could cause confusion.
Adcurare assesses methodological rigor, not the importance of the findings. See how we evaluate →