Rigor Reviewed

Rigor-Reviewed Manuscript

Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.

Name: Adcurare Rigor Record — Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.
Item: Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.
Rating: 92
Author: Adcurare

Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Avasarala SK, Casey JD, Cheng GZ, D'Haese PF, Duke JD, Grogan EL, Hoopman TC, Johnson J, Katsis JM, Kurman JS, Low SW, Mahmood K, Rickman OB, Roller L, Salmon C, Shojaee S, Swanner B, Wahidi MM, Walston C, Silvestri GA, Yarmus L, Rahman NM, Maldonado F, Interventional Pulmonary Outcomes Group

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Adcurare Rigor Review — 3.5★ (Adequate), 0 critical, 7 high issues for “Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingData & code availability not met−0.5★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced3 types

Data and code not shared
Internal contradictions in the reported numbers
Other integrity concern

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 describes a well-designed multicenter randomized trial comparing navigational bronchoscopy to transthoracic biopsy. The main weaknesses are a missing data availability statement, no explicit reference to an ethical regulatory framework, and minor statistical reporting imprecisions.

All three reviewers agreed on most dimensions; the divergence on ethical approvals and data code availability was resolved by weighing the specific evidence. Key resources were partially incomplete (needle specifications). The statistics recomputation checked only 1 test and found it consistent. No retracted or unfindable references were found.

9 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 1 test: 1 consistent, 0 inconsistent, 1 via agent-written checks.

2 integrity concerns flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 fail

The introduction cites multiple references on diagnostic accuracy and complications of both techniques, notes the lack of randomized comparisons, and describes the hypothesis of noninferiority. The limitations of prior work (selection bias, publication bias) are explicitly addressed by the trial design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise by citing prior single-arm studies and meta-analyses, acknowledging their limitations, and providing a rationale for the randomized trial.

Evidence

direct quote[Introduction, paragraph 2]

“No randomized trials have compared navigational bronchoscopy to transthoracic biopsy.”

direct quote[Introduction, paragraph 2]

“Diagnostic accuracy estimates for both modalities have been derived from single-arm studies at high risk for selection, referral, and publication biases.”

PASSReviewer 2· 95% conf

The scientific premise is well-established with citations to prior research, a clear rationale, and explicit acknowledgement of limitations in prior studies.

Evidence

direct quote[Introduction, paragraphs 1-3]

“Diagnostic accuracy estimates for both modalities have been derived from single-arm studies at high risk for selection, referral, and publication biases.”

direct quote[Introduction, last paragraph]

“We hypothesized the diagnostic accuracy of navigational bronchoscopy would be non-inferior to that of transthoracic biopsy.”

direct quote[Introduction, paragraph 3]

“No randomized trials have compared navigational bronchoscopy to transthoracic biopsy.”

PASSReviewer 3· 95% conf

The scientific premise is well-established through extensive citation of prior work, a clear rationale linking the evidence gap to the study hypothesis, and a discussion of limitations in prior single-arm studies.

Evidence

direct quote[Introduction, paragraphs 1-3]

“No randomized trials have compared navigational bronchoscopy to transthoracic biopsy.”

direct quote[Introduction, final paragraph]

“We hypothesized the diagnostic accuracy of navigational bronchoscopy would be non-inferior to that of transthoracic biopsy.”

direct quote[Introduction, paragraph 3]

“Diagnostic accuracy estimates for both modalities have been derived from single-arm studies at high risk for selection, referral, and publication biases.”

Randomization was performed using permuted blocks of variable size, stratified by nodule location, pre-test probability, and site. The trial was unblinded due to the nature of interventions, but outcome assessors were blinded. A sample size calculation was provided with 80% power. The primary analysis population was defined excluding those with interval imaging changes or not reporting. The comparator arm served as control.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design is rigorous with clear randomization, blinding of outcome assessors, a pre-specified power analysis, and well-defined inclusion/exclusion criteria.

Evidence

direct quote[Methods, paragraph 3]

“Fully eligible patients were randomly allocated 1:1 to navigational bronchoscopy or transthoracic biopsy, in permuted blocks of variable size, stratified by nodule location (middle third or outer third of the lung), pre-test probability of malignancy (≤50% or >50%), and study site, using a cloud-based randomization tool.”

direct quote[Methods, paragraph 3]

“Outcome assessors were blinded to group assignment.”

direct quote[Methods, Statistical Analysis]

“Diagnostic accuracy of TTNB was assessed at 90%, with noninferiority margin of 10%, one-sided type I error rate of 5%, and power of 80%, yielding a sample of n=112 per group, increased 15% to account for attrition to total n=258.”

PASSReviewer 2· 95% conf

The study design is rigorous: randomization with stratification, blinded outcome adjudication, a priori power analysis, and clear inclusion/exclusion criteria.

Evidence

direct quote[Methods, Enrollment, Randomization, and Blinding]

“Fully eligible patients were randomly allocated 1:1 to navigational bronchoscopy or transthoracic biopsy, in permuted blocks of variable size, stratified by nodule location... pre-test probability of malignancy... and study site.”

direct quote[Methods, Statistical Analysis]

direct quote[Methods, Trial Sites and Patient Population]

“Adults referred for bronchoscopic or transthoracic biopsy of a single, peripheral, indeterminate pulmonary nodule 10 to 30 mm in diameter, with a calculated pre-test probability of malignancy of at least 10%, were eligible.”

PASSReviewer 3· 92% conf

The study design is rigorous for a human RCT, with clear randomization, blinding of outcome assessors, a pre-specified power analysis, and well-defined inclusion/exclusion criteria. The unblinded nature of the intervention is acknowledged.

Evidence

direct quote[Methods, Enrollment, Randomization, and Blinding]

“Outcome assessors were blinded to group assignment.”

direct quote[Methods, Statistical Analysis]

The table reports age, sex, race, ethnicity, comorbidities, BMI, smoking history, and nodule characteristics. Both sexes are included, so a sex justification is not needed.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Biological variables including sex, age, BMI, comorbidities, and demographics are reported in Table 1.

Evidence

direct quote[Table 1]

“Female sex: 57 (47%) and 56 (50%); Age: 66.0 (62.0–72.0) and 68.0 (61.0–74.0)”

direct quote[Table 1]

“White: 109 (90%) and 104 (92%); Black: 9 (7%) and 5 (4%); Hispanic ethnicity: 0 and 3 (3%)”

PASSReviewer 2· 95% conf

Biological variables including sex, age, BMI, comorbidities, and demographics are well reported in Table 1.

Evidence

direct quote[Table 1]

“Female sex: 57 (47%) vs 56 (50%); Age: 66.0 (62.0–72.0) vs 68.0 (61.0–74.0)”

direct quote[Table 1]

“Body mass index: 27.6 (23.9–31.5) vs 27.9 (24.0–31.2); COPD: 49 (40%) vs 48 (42%)”

PASSReviewer 3· 95% conf

Biological variables and subject characteristics are comprehensively reported in Table 1, meeting the applicable criteria for a human interventional trial.

Evidence

direct quote[Table 1]

“Female sex: 57 (47%) [NB] / 56 (50%) [CT-TTNB]”

direct quote[Table 1]

“White: 109 (90%), Black: 9 (7%), Asian: 2 (2%); Hispanic ethnicity: 0 / 3 (3%)”

The paper states that the trial was approved by the institutional review board at the Clinical Coordinating Center and all enrolling sites. Informed consent is explicitly mentioned. Regulatory compliance with the Declaration of Helsinki and other applicable regulations is implied through the IRB process and trial registration, and the paper includes a statement from the authors vouching for fidelity to the protocol.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The paper reports IRB approval and informed consent, but does not explicitly state compliance with a recognized regulatory framework (e.g., Declaration of Helsinki).

Evidence

direct quote[Methods, Trial Design and Oversight]

“It was approved by the institutional review board at the Clinical Coordinating Center, Vanderbilt University Medical Center, and all enrolling sites”

direct quote[Methods, Enrollment, Randomization, and Blinding]

“After provision of informed consent”

absence[Methods]

No statement of regulatory compliance.

PASSReviewer 2· 90% conf

Ethics approval and informed consent are explicitly reported.

Evidence

direct quote[Methods, Trial Design and Oversight]

“It was approved by the institutional review board at the Clinical Coordinating Center, Vanderbilt University Medical Center, and all enrolling sites.”

direct quote[Methods, Enrollment, Randomization, and Blinding]

“After provision of informed consent, chest imaging was centrally reviewed...”

PASSReviewer 3· 95% conf

Ethical approvals are adequately reported. The IRB approval, informed consent, and regulatory compliance are all documented.

Evidence

direct quote[Methods, Trial Design and Oversight]

“It was approved by the institutional review board at the Clinical Coordinating Center, Vanderbilt University Medical Center, and all enrolling sites”

direct quote[Methods, Enrollment, Randomization, and Blinding]

“After provision of informed consent, chest imaging was centrally reviewed...”

direct quote[Methods, Trial Design and Oversight]

“...and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.”

The bronchoscopy platform is named as ILLUMISITE™ Fluoroscopic Navigation Platform, Medtronic, with location. The statistical software is R version 4.4. No other key resources are used.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The investigational product (navigational bronchoscopy platform) and software are identified with vendor and version.

Evidence

direct quote[Methods, Trial Intervention]

“ILLUMISITE™ Fluoroscopic Navigation Platform, Medtronic, Minneapolis, MN, USA”

direct quote[Methods, Statistical Analysis]

“All the analyses were performed with the use of R software, version 4.4.”

WARNReviewer 2· 80% conf

The navigational bronchoscopy platform is identified, but the transthoracic biopsy needle type and size are not specified.

Evidence

direct quote[Methods, Trial Intervention]

“Patients assigned to bronchoscopy underwent electromagnetic navigational bronchoscopy with integrated digital tomosynthesis (ILLUMISITE™ Fluoroscopic Navigation Platform, Medtronic, Minneapolis, MN, USA).”

paraphrase[Methods, Trial Intervention]

“The number, size, and type of biopsy needle for transthoracic biopsy were at the discretion of the proceduralist, but no actual needle specifications are reported.”

PASSReviewer 3· 90% conf

Key resources are adequately identified. The investigational product (navigational bronchoscopy platform) is named with manufacturer, and software is identified. Other bench-resource sub-criteria are not applicable.

Evidence

direct quote[Methods, Trial Intervention]

direct quote[Methods, Statistical Analysis]

“All the analyses were performed with the use of R software, version 4.4.”

The primary analysis uses a z-test for noninferiority, which is named. Exact p-values are reported (p=0.003 for noninferiority, p=0.17 for superiority). Effect sizes (absolute difference) and 95% confidence intervals are reported. Software (R 4.4) is identified. Data presentation includes a CONSORT-like flow diagram, tables with per-group n and percentages, and appropriate clinical display. Assumptions for the z-test (large sample approximation) are implicit. Mathematical plausibility checks: The reported percentages and Ns are consistent (e.g., 94/119=79.0%, 81/110=73.6%). The overall score calculation is based on pass=3 for all applicable dimensions.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical tests are named, effect sizes with CIs are reported, and software is identified. However, exact p-values for secondary outcomes are not always provided (e.g., p<0.01).

Evidence

direct quote[Methods, Statistical Analysis]

“Noninferiority of bronchoscopy was tested using a z-test with noninferiority margin of 10 percentage points”

direct quote[Abstract]

“p = 0.003 for noninferiority; p = 0.17 for superiority”

direct quote[Table 3]

“P value <0.01”

PASSReviewer 2· 85% conf

Statistical analysis is generally adequate: tests named, effect sizes with CIs, software identified, data presentation appropriate. Minor issues: exact p-values not given for all outcomes; assumptions not explicitly verified.

Evidence

direct quote[Methods, Statistical Analysis and Results]

“p = 0.003 for noninferiority; p = 0.17 for superiority”

direct quote[Results, Primary Outcome]

“absolute difference, 5.4 percentage points; 95% CI, −6.5 to 17.2”

absence[Methods, Statistical Analysis]

Assumptions not explicitly verified.

PASSReviewer 3· 88% conf

Statistical analysis is rigorous. Tests are named, the noninferiority test is described, exact p-values are reported for the primary outcome, and data presentation follows clinical trial standards.

Evidence

direct quote[Methods, Statistical Analysis; Results, Primary Outcome]

“Noninferiority of bronchoscopy was tested using a z-test... p = 0.003 for noninferiority; p = 0.17 for superiority”

direct quote[Results, Primary Outcome]

“absolute difference, 5.4 percentage points; 95% Confidence Interval [CI], −6.5 to 17.2”

direct quote[Methods, Statistical Analysis]

“All the analyses were performed with the use of R software, version 4.4.”

No data availability statement is present in the text. The trial is registered, but no data access mechanism is described. For a clinical trial, a data sharing statement is expected, even if controlled access is required.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 95% conf

The paper does not include a data availability statement, and trial data are not deposited in a public repository. Code sharing is not applicable.

Evidence

absence[Entire text]

No data availability statement.

FAILReviewer 2· 95% conf

No data availability statement or code sharing is provided.

Evidence

absence[Entire manuscript]

No data availability statement found.

absence[Entire manuscript]

No code repository mentioned.

WARNReviewer 3· 85% conf

The trial is registered and the protocol is published, but no data availability statement or code sharing is explicitly mentioned in the provided text.

Evidence

absence[Entire manuscript]

No data availability statement is present in the provided paper text.

absence[Entire manuscript]

No statement about sharing analysis code is present.

The methods are comprehensive. The trial is registered with NCT04250194. All primary and secondary outcomes are reported. Limitations are thoroughly discussed. Conclusions are proportional. Disclosure forms are available. No CONSORT or other checklist is mentioned.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper has detailed methods, trial registration, reports all outcomes, discusses limitations, and includes funding/COI disclosure. However, no explicit reporting guideline is referenced.

Evidence

direct quote[Abstract]

“NCT04250194”

direct quote[Funding information]

“This work is supported by a research grant from Medtronic (Fridley, Minnesota, USA) and the Pierre Massion Directorship in Pulmonary Medicine (F.M.).”

PASSReviewer 2· 90% conf

Reporting is generally transparent: methods detailed, trial registered, all outcomes reported, limitations discussed, and conclusions proportional.

Evidence

direct quote[Abstract and Methods]

“ClinicalTrials.gov NCT04250194”

direct quote[Discussion, paragraphs 3-4]

“This study also has several limitations.”

direct quote[End of manuscript]

“This work is supported by a research grant from Medtronic... Disclosure forms provided by the authors are available.”

WARNReviewer 3· 85% conf

Reporting is mostly transparent with a published protocol and discussion of limitations, but lacks a specific reporting guideline checklist reference and the trial registration number is placed differently.

Evidence

direct quote[Abstract; Methods, Trial Design and Oversight]

“Trial registration : ClinicalTrials.gov NCT04250194”

absence[Methods section]

No reference to a reporting guideline (e.g., CONSORT) is found.

direct quote[Discussion, final paragraphs]

“This study also has several limitations.”

1 copyedit issue flagged: mostly consistency.

Checked 26 references: 22 verified — 4 not checked.

Reproducibility

2 data/code links checked; 2 live.

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is close to submission-ready but requires two critical additions (data availability statement, ethics regulation statement) and several medium-priority fixes before it clears a journal's pre-submission checks.

1.
HIGHdata code
Add a Data Availability section before the References stating how de-identified patient data can be accessed (e.g., 'De-identified participant data will be shared on reasonable request to the corresponding author, subject to a data use agreement.')
A data availability statement is a journal requirement; its absence is likely to trigger a mandatory revision or return.
2.
HIGHethics
Add a sentence in the Methods (Trial Design and Oversight) explicitly stating that the trial was conducted in accordance with the Declaration of Helsinki (or applicable local regulations).
The paper reports IRB approval but omits the standard regulatory-compliance statement, which reviewers and editors universally expect.
3.
HIGHreporting
Fix the abstract so that the per-group denominators (119 + 110 = 229) reconcile with the reported total of 234 patients in the primary analysis, by adding a clarifying sentence (e.g., 'Five patients were lost to follow-up and were excluded from the primary analysis.')
The discrepancy (234 vs 229) is a consistency error that a careful copyeditor or reviewer will catch and question.
4.
HIGHreporting
Reference a reporting guideline (CONSORT) in the Methods, and submit a completed CONSORT checklist as supplementary material.
Journals typically require submission of a completed reporting checklist; its absence is a procedural gap.
5.
HIGHrigor
Specify the type, gauge, and size of the biopsy needle(s) used for transthoracic biopsy in the Methods (Trial Intervention).
The needle specification is a key resource detail needed for reproducibility; its absence was flagged by one reviewer.
6.
HIGHstatistics
Report exact p-values (e.g., 0.0045) for all secondary safety outcomes in Table 3 and the text, replacing threshold values like 'p<0.01'.
Precise p-values allow readers to assess the strength of evidence; threshold reporting is a common reviewer criticism.
7.
HIGHstatistics
Add a sentence in the Methods (Statistical Analysis) describing any assumption checks performed for the primary z-test (e.g., normality of the difference distribution or the use of a large-sample approximation).
Statistical test assumptions are part of rigorous reporting even when the test is robust to moderate violations.
8.
MEDIUMreporting
Provide a brief justification for the chosen noninferiority margin of 10 percentage points, citing a clinical precedent or a consensus statement.
A noninferiority margin should be clinically justified; its absence can be questioned during review.
9.
MEDIUMreporting
Describe the software used for the sample-size calculation (e.g., nQuery, PASS) and any key assumptions (e.g., expected event rate) in the Methods.
Transparency in sample-size software and assumptions strengthens the power analysis reporting.
10.
MEDIUMdata code
Share custom analysis code (e.g., R scripts for the primary noninferiority test and key figures) in a public repository (e.g., Zenodo, GitHub) and include the DOI or link in the manuscript.
Code sharing supports computational reproducibility, even though it is not universally required; it is a best practice increasingly expected by journals.
11.
LOWreporting
Add a sentence in the Discussion about generalizability of the results to non-academic centers with less experienced bronchoscopists.
The trial was conducted at tertiary academic centers; acknowledging this limitation helps readers interpret the applicability of findings.

Full text (39,280 chars)Analyzed: Jul 7, 2026

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Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.

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DOI

10.1056/NEJMoa2414059

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Issued Jul 7, 2026Engine 7.6.0

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