Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial
Li Y, Zhu X, Li LJ, Chen L, Yang Q, Xu L, Liang W, Lin X, Li C, Xue J, Liu L, Pan X, Ju R, Peng X, Tang W, Shi Y, NHFOV study group.
Paper source
Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial
This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026
How this rating was calculated▸
Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.
No specific rigor problems surfaced by the checks that ran.
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.
The manuscript presents a well-designed multicentre RCT with clear randomisation, masked outcome assessment, adequate power, and transparent reporting. Two minor but fixable gaps are identified: (1) the regulatory compliance statement does not explicitly cite the Declaration of Helsinki or ICH-GCP, and (2) the analysis code is only in supplemental files rather than a version-controlled public repository. No integrity or fabrication signals were detected.
Three independent rigor evaluations were synthesised; the reviewers agreed on 6 of 8 dimensions, with divergence on ethical approvals (2 pass, 1 warn) and data code availability (2 pass, 1 warn). The copyedit pass identified 8 minor issues. Citation verification found no retracted or missing references (37 checked). 6 statistics recomputed all consistent. The data link is live.
12 major claims checked against the paper's own evidence: all adequately supported.
Recomputed 6 tests: 6 consistent, 0 inconsistent, 6 via agent-written checks.
8 copyedit issues flagged: mostly typo, consistency, clarity.
Checked 37 references: 36 verified — 1 not checked.
1 data/code link checked; 1 live.
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
The manuscript is ready after minor edits. The two warn-rated items (ethics framework statement, code repository) and the copyedit fixes (stray backtick, typo, Table 3 footnote mislabel) should be addressed before submission; none are likely to cause rejection if fixed.
- 1.HIGHethicsAdd an explicit statement that the trial was conducted in accordance with the Declaration of Helsinki and/or ICH-GCP guidelines in the Methods (Study design) section, alongside the existing CONSORT compliance statement.Current regulatory compliance only references CONSORT (a reporting guideline), not an international ethical framework; this is required for ethical approvals adequacy.
- 2.HIGHdata codeUpload the analysis code to a version-controlled public repository (e.g., GitHub, Zenodo, or OSF) with a persistent DOI and update the Data availability statement accordingly.Code in supplemental files lacks version control and a permanent identifier, which is increasingly expected for full reproducibility.
- 3.MEDIUMstatisticsAdd a brief sentence in the Statistical analysis section describing whether test assumptions (normality, equal variance) were verified and, if so, the results (e.g., 'Normality was assessed using the Shapiro-Wilk test; non-parametric tests were used where assumptions were violated').The absence of formal assumption verification was noted as a minor gap; making it explicit raises reporting quality.
- 4.MEDIUMstatisticsAdd a statement on how outliers in continuous outcomes were handled, or state that no data were excluded as outliers, in the Statistical analysis section.Standard reporting practice for clinical trials to clarify a priori handling of extreme values.
- 5.MEDIUMcopyeditRemove the stray backtick after 'of' in the Abstract (Results): '27 of` 170' should read '27 of 170'.Stray punctuation is a typographical error that will be noted by editors.
- 6.MEDIUMcopyeditCorrect the typo in the Affiliations section: 'Technology & Resrach (A*STAR)' to 'Technology & Research (A*STAR)'.Spelling error in author affiliations undermines manuscript polish.
- 7.MEDIUMcopyeditRevise the Table 3 footnote that states 'Risk difference reported as median (interquartile range)'; if a difference in medians is reported, rephrase to 'Difference in medians (interquartile range)' or clarify what is actually being presented.Risk difference is a measure for proportions; mislabeling a median difference could confuse readers and editors.
- 8.MEDIUMreportingIn the Discussion (Strengths and limitations), consider breaking the long sentence about surfactant redosing into two sentences for clarity.Long sentences reduce readability; the copyedit flagged this as a clarity issue.
- 9.LOWreportingReport the number of infants screened per site to allow assessment of site-level variability in recruitment.Highly recommended for multicentre trials, though not required; enhances transparency.
- 10.LOWcopyeditStandardise the spelling of 'mm Hg' throughout the manuscript (Methods and Table 1) to ensure consistent presentation.Minor consistency issue flagged by the copyedit pass.
- 11.LOWstatisticsConsider providing exact p-values (e.g., 0.22) rather than threshold statements for all secondary outcomes (already partially done in tables; verify consistency in text).Exact p-values are already reported in tables; ensure the text also uses exact values where applicable.
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