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Kaimen Rigor review

Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.

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

DOI: 10.1056/NEJMoa2414059
Record issued: 2026-08-10
Engine: 7.29.0
Exported: 2026-09-22

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/ea8e5156-7fc0-460a-b667-f1ab87ab9ce0 is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

1.25 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern ×5−2.5★
ReportingData & code availability not met−0.5★
CitationsUnresolved reference ×2−0.5★
ReportingEthical approvals partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.29.0Source: full text

Biggest issues

01Data and code not shared
highDisclosurereviewer-assessedFull detail
No data availability statement is provided, and no custom code is shared. This is a significant omission for a clinical trial.
02Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
Abstract reports pneumothorax rates as 3.4% and 34.8% and chest tube rates as 0.9% and 14.1%, whereas Results and Table 3 report 3.3%, 28.3%, 0.8%, and 11.5%. The abstract appears to use different denominators.
Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group with chest tube thoracostomy or admission occurring in one patient (0.9%) and 13 patients (14.1%), respectively. |…
Table 3reviewer’s wording
03Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The abstract reports pneumothorax in the transthoracic biopsy group as 34.8%, but the Results section and Table 3 report 28.3%. This is a clear discrepancy that could mislead readers.
Abstract: 'Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group' vs Results: 'Pneumothorax was most common, occurring in 4 patients (3.3%) in the navigational…
Table 3reviewer’s wording
04Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The abstract reports different safety percentages than the Results section and Table 3 for identical event counts: pneumothorax 34.8% vs 28.3%, and chest tube/admission 14.1% vs 11.5%, with no stated denominator in the abstract that reconciles these values.
“Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group with chest tube thoracostomy or admission occurring in one patient (0.9%) and 13 patients (14.1%), respectively.”
AbstractFind in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 105AvailabilityBroken references and links 106CopyeditCopyediting

This Kaimen Rigor review uses Kaimen 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 VERITAS trial is a well-designed multicenter randomized noninferiority trial with clear methods and transparent reporting. Its main weaknesses are the absence of a data availability statement, minor imprecision in p-value reporting, and a critical internal discrepancy in the abstract safety percentages that requires correction.

All eight dimensions were applicable. The reviewers diverged on key resources (warn vs pass) and statistical analysis (pass vs warn); the synthesized statuses reflect the majority or more evidence-based judgment. The statistics verification component checked only 3 tests (all consistent); coverage is limited and does not constitute a comprehensive audit.

Numerical inconsistencies

1 finding · worst medium

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 3 tests: 3 consistent, 0 inconsistent; 3 via agent-written checks.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p = .003 · recomputed p = .003Reviewer 2
One-sided p-value for noninferiority of navigational bronchoscopy vs transthoracic biopsy, using a z-test with margin of 10 percentage points.
“biopsy resulted in a specific diagnosis in 94 of 119 cases (79.0%) in the navigational bronchoscopy group, compared to 81 of 110 cases (73.6%) in the transthoracic biopsy group (absolute difference, 5.4 percentage points; 95% confidence interval, −6.5 to 17.2 (p = 0.003 for noninferiority; p = 0.17 for superiority).”
Find in source
Taken as given: The test is a one-sided z-test for noninferiority with a margin of 10 percentage points.; The observed proportions are 94/119 and 81/110 from the primary analysis.; The standard error is computed using unpooled group-specific variances.; The z-statistic follows a standard normal distribution.
Method: Computed the one-sided normal-theory p-value: z = (difference + margin) / SE, p = 1 - normalCdf(z).
How we recomputed it: 1 - normalCdf( ( (94/119 - 81/110) + 0.10 ) / Math.sqrt( (94/119)*(1 - 94/119)/119 + (81/110)*(1 - 81/110)/110 ) )
CONSISTENTreported p = .960 · recomputed p = .961Reviewer 3
Recompute p for respiratory failure requiring admission from 2×2 counts (1/121 vs 1/113) using Pearson chi-square.
“Respiratory failure requiring admission | 1 (0.8%) | 1 (0.9%) | 0.1% (−2.5 to 2.4) | 0.96”
Find in source
Taken as given: The table header n=121 and n=113 are the denominators for each arm; The event counts are 1 in each arm; Pearson chi-square without continuity correction is the method used
Method: Pearson chi-square on the 2×2 table of counts, two-tailed.
How we recomputed it: pChi2x2(1,120,1,112)
CONSISTENTreported p = .330 · recomputed p = .333Reviewer 3
Recompute p for acute coronary syndrome from 2×2 counts (1/121 vs 0/113).
“Acute coronary syndrome | 1 (0.8%) | 0 | 0.8% (−1.6 to 3.3) | 0.33”
Find in source
Taken as given: The table header n=121 and n=113 are the denominators; Event counts are 1 and 0; Pearson chi-square without continuity correction is the method used
Method: Pearson chi-square on the 2×2 table of counts, two-tailed.
How we recomputed it: pChi2x2(1,120,0,113)

highinternal contradiction
Abstract reports pneumothorax rates as 3.4% and 34.8% and chest tube rates as 0.9% and 14.1%, whereas Results and Table 3 report 3.3%, 28.3%, 0.8%, and 11.5%. The abstract appears to use different denominators.
Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group with chest tube thoracostomy or admission occurring in one patient (0.9%) and 13 patients (14.1%), respectively. | Pneumothorax was most common, occurring in 4 patients (3.3%) in the navigational bronchoscopy group and 32 patients (28.3%) in the transthoracic biopsy group
Table 3reviewer’s wording
highinternal contradiction
The abstract reports pneumothorax in the transthoracic biopsy group as 34.8%, but the Results section and Table 3 report 28.3%. This is a clear discrepancy that could mislead readers.
Abstract: 'Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group' vs Results: 'Pneumothorax was most common, occurring in 4 patients (3.3%) in the navigational bronchoscopy group and 32 patients (28.3%) in the transthoracic biopsy group'
Table 3reviewer’s wording
mediuminternal contradiction
The abstract reports different safety percentages than the Results section and Table 3 for identical event counts: pneumothorax 34.8% vs 28.3%, and chest tube/admission 14.1% vs 11.5%, with no stated denominator in the abstract that reconciles these values.
“Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group with chest tube thoracostomy or admission occurring in one patient (0.9%) and 13 patients (14.1%), respectively.”
AbstractFind in source
lowinternal contradiction
Table 2 states 88 (77.6%) for diagnostic yield in the transthoracic biopsy group, but 88/113 = 77.9%, a rounding/typographical inconsistency.
“| Diagnostic | 96 (79.3%) | 88 (77.6%) | 1.5 (−9.9 to 12.8) |”
Table 2Find in source

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

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

partialReviewers 1, 2, 3
Navigational bronchoscopy should be the procedure of choice for biopsy of indeterminate lung nodules that are technically amenable to both approaches.
The noninferiority and safety data support this recommendation, but the study's limitations (experienced operators, exclusion of some nodules) mean the claim is somewhat stronger than the evidence strictly allows; however, it is acknowledged in the Discussion.
Evidence: Noninferiority demonstrated and fewer complications. The authors acknowledge limitations in the Discussion.
“The results of this trial suggest that navigational bronchoscopy, with similar diagnostic accuracy to transthoracic biopsy but fewer complications, should be the procedure of choice for biopsy of indeterminate lung nodules that appear technically amenable to both approaches.”
Discussion ¶1Find in source
supportedReviewer 1
Navigational bronchoscopy is noninferior to transthoracic biopsy for diagnostic accuracy.
The noninferiority p-value (0.003) and the confidence interval (-6.5 to 17.2) exclude the noninferiority margin of -10%, supporting the claim.
Evidence: Primary outcome results: 94/119 (79.0%) vs 81/110 (73.6%), difference 5.4% (95% CI -6.5 to 17.2), p=0.003 for noninferiority.
biopsy resulted in a specific diagnosis in 94 of 119 cases (79.0%) in the navigational bronchoscopy group, compared to 81 of 110 cases (73.6%) in the transthoracic biopsy group (absolute difference, 5.4 percentage points; 95% confidence interval, −6.5 to 17.2; p = 0.003 for noninferiority; p = 0.17 for superiority).
Abstractreviewer’s wording
supportedReviewer 1
Complications are less common during navigational bronchoscopy.
The safety data show significantly lower rates of pneumothorax and related interventions in the bronchoscopy group, with p-values <0.01.
Evidence: Safety outcomes: any complication 5.0% vs 29.2% (difference 24.2%, 95% CI 15.0-35.6); pneumothorax 3.3% vs 28.3%.
A procedural complication occurred in 6 of 121 cases (5.0%) in the navigational bronchoscopy group compared to 33 of 113 cases (29.2%) in the transthoracic biopsy group (absolute risk difference 24.2 percentage points; 95% CI, 15.0 to 35.6).
Table 3reviewer’s wording
supportedReviewers 2, 3
The diagnostic accuracy of navigational bronchoscopy was noninferior to that of transthoracic biopsy in patients with pulmonary nodules 10–30 mm.
The primary outcome shows the lower bound of the 95% CI (−6.5) is above the prespecified noninferiority margin (−10 percentage points), establishing noninferiority.
Evidence: Primary outcome: 94/119 (79.0%) vs 81/110 (73.6%), difference 5.4 percentage points, 95% CI −6.5 to 17.2, p=0.003 for noninferiority.
“The diagnostic accuracy of navigational bronchoscopy was noninferior to that of transthoracic biopsy in patients with pulmonary nodules 10–30 mm.”
AbstractFind in source
supportedReviewers 2, 3
Complications were less common during bronchoscopy.
Safety outcomes show a substantially lower rate of any complication and pneumothorax in the bronchoscopy group.
Evidence: Any complication 6/121 (5.0%) vs 33/113 (29.2%), absolute risk difference 24.2 percentage points (95% CI 15.0 to 35.6); pneumothorax 4 (3.3%) vs 32 (28.3%).
“Complications were less common during bronchoscopy.”
DiscussionFind in source
supportedReviewer 2
The performance of navigational bronchoscopy in this trial is comparable to prior studies using the same technique, which have reported yields ranging from 79% to 83%.
The trial's diagnostic yield of 79.3% falls within the cited range of 79–83%.
Evidence: Diagnostic yield 96/121 (79.3%) in the bronchoscopy group (Table 2).
“The performance of navigational bronchoscopy in this trial is comparable to prior studies using the same technique, which have reported yields ranging from 79% to 83%.”
DiscussionFind in source
supportedReviewer 3
Transthoracic biopsy performed worse than previously reported.
The observed 73.6% diagnostic accuracy is lower than the up-to-90% historical estimates cited in the introduction, and the authors explain likely reasons.
Evidence: Treatment-group diagnostic accuracy 73.6% (81/110) in the primary analysis, compared with prior single-arm estimates of up to 90%.
“Transthoracic biopsy performed worse than previously reported.”
Discussion ¶2Find in source

Data authenticity concerns

1 finding · worst low

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Methods and results do not matchAssessed

5 integrity concerns flagged (2 high).

lowmethod result mismatch
The reported superiority p-value of 0.17 is approximately half the two-sided z-test p-value (~0.34) for the primary difference, suggesting it may be the one-sided p-value.
“p = 0.003 for noninferiority; p = 0.17 for superiority”
AbstractFind in source

Reporting gaps

2 findings · worst high

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data and code not sharedAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 1 warn · 1 fail

Prior work is cited (references 1-20) highlighting the trade-offs between transthoracic biopsy (high accuracy, high pneumothorax) and navigational bronchoscopy (lower pneumothorax, historically lower accuracy). The paper notes that no randomized trials have compared them and that estimates come from single-arm studies with bias. The hypothesis follows logically from the evidence.

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 research on both modalities, acknowledging their limitations, and providing a logical rationale for the trial.

Evidence

paraphrase[Introduction, paragraph 1]

“Transthoracic biopsy is guided by intraprocedural three-dimensional CT images, providing an accurate diagnosis in up to 90% of cases, but requires passing a needle through the chest wall and pleura causing pneumothorax in up to 25% of cases.”

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

Introduction ¶2Find in source

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

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper clearly establishes the clinical uncertainty around diagnostic accuracy of the two biopsy modalities and cites prior single-arm studies and meta-analyses, acknowledging their biases.

Evidence

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

IntroductionFind in source

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

IntroductionFind in source

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

IntroductionFind in source

PASSReviewer 3· 90% conf

The paper clearly establishes the clinical need, cites prior evidence for both modalities, and motivates a head-to-head randomized comparison.

Evidence

“Transthoracic biopsy is guided by intraprocedural three-dimensional CT (computed tomography) images, providing an accurate diagnosis in up to 90% of cases, but requires passing a needle through the chest wall and pleura causing pneumothorax in up to 25% of cases.”

Introduction ¶1Find in source

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

Introduction ¶2Find in source

paraphrase[Introduction, paragraph 3]

“No randomized trials have compared navigational bronchoscopy to transthoracic biopsy. To compare the effect of navigational bronchoscopy to that of transthoracic biopsy on diagnostic accuracy among patients undergoing biopsy of a peripheral pulmonary nodule, we conducted the ... (VERITAS) trial. We hypothesized the diagnostic accuracy of navigational bronchoscopy would be non-inferior to that of transthoracic biopsy.”

Randomization was performed using permuted blocks of variable size, stratified by nodule location, pre-test probability, and site, with a cloud-based tool. The unit of randomization is the patient. A priori power analysis was conducted (n=258, 80% power, 5% alpha). Inclusion/exclusion criteria are detailed. The analysis population is pre-specified. Outcome assessors were blinded; the open-label design is justified by the nature of the interventions.

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 well-described with adequate randomization, power analysis, sample size, inclusion/exclusion criteria, and blinding of outcome assessors.

Evidence

paraphrase[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 (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.”

“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.”

Statistical analysisFind in source

“Outcome assessors were blinded to group assignment.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomized, multicenter, with a priori power calculation, clear inclusion/exclusion criteria, and blinded outcome assessment despite open-label allocation.

Evidence

paraphrase[Methods, Enrollment, Randomization, and Blinding]

“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.”

“Outcome assessors were blinded to group assignment.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 3· 95% conf

The trial design is rigorous for a randomized noninferiority trial, with clear randomization, blinding of outcome assessors, a pre-specified sample size calculation, and explicit inclusion/exclusion and analysis-population definitions.

Evidence

paraphrase[Methods, Enrollment, Randomization, and Blinding]

“Clinicians and research personnel were aware of trial-group assignments after randomization given the nature of the intervention. Outcome assessors were blinded to group assignment.”

MethodsFind in source

paraphrase[Methods, Statistical Analysis]

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

Sex is reported for both groups (47% female in bronchoscopy, 50% in transthoracic biopsy). Age, BMI, comorbidities, smoking history, and nodule characteristics (size, density, location) are reported. Since both sexes are included, sex justification is not applicable.

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

Demographic and clinical variables (age, sex, race, comorbidities, nodule characteristics) are well-reported in Table 1.

Evidence

paraphrase[Table 1]

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

paraphrase[Table 1]

“Age: 66.0 (62.0–72.0) | 68.0 (61.0–74.0)”

PASSReviewer 2· 95% conf

Demographic and clinical characteristics are thoroughly reported in Table 1, including age, sex, race, ethnicity, and comorbidities.

Evidence

“Female sex | 57 (47%) | 56 (50%)”

Table 1Find in source

“Age | 66.0 (62.0–72.0) | 68.0 (61.0–74.0)”

Table 1Find in source

“Hispanic ethnicity | 0 | 3 (3%)”

Table 1Find in source

PASSReviewer 3· 90% conf

Key demographic and clinical baseline variables are reported in Table 1, including age, sex, race, ethnicity, comorbidities, BMI, and nodule characteristics.

Evidence

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

Table 1Find in source

“Body mass index | 27.6 (23.9–31.5) | 27.9 (24.0–31.2)”

Table 1Find in source

“Diameter | 15.0 (12.5–20.0) | 14.5 (12.0–18.1)”

Table 1Find in source

The paper states that the trial was approved by the institutional review board at Vanderbilt University Medical Center and all enrolling sites, and that informed consent was obtained. However, it does not mention compliance with the Declaration of Helsinki or other specific regulatory framework, which is a standard expectation for human trials. This is a minor reporting gap.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

IRB approval and informed consent are reported, but the paper does not explicitly state adherence to a recognized regulatory framework (e.g., Declaration of Helsinki).

Evidence

“It was approved by the institutional review board at the Clinical Coordinating Center, Vanderbilt University Medical Center, and all enrolling sites, and was registered at ClinicalTrials.gov (https://ClinicalTrials.gov) before initiation.”

MethodsFind in source

“After provision of informed consent, chest imaging was centrally reviewed by at least one interventional radiologist and one interventional pulmonologist to confirm the case was technically amenable to both navigational bronchoscopy and transthoracic biopsy.”

MethodsFind in source

absence[Throughout paper]

No explicit statement of adherence to Declaration of Helsinki or other regulatory framework.

WARNReviewer 2· 85% conf

The trial reports IRB approval and informed consent, but does not mention regulatory compliance with a recognized framework, and the consent type is not specified.

Evidence

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

MethodsFind in source

“After provision of informed consent”

MethodsFind in source

absence[Full text]

No regulatory compliance statement is present.

WARNReviewer 3· 70% conf

IRB approval and informed consent are reported, but no explicit statement of regulatory compliance (e.g., Declaration of Helsinki or ICH-GCP) is provided.

Evidence

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

MethodsFind in source

“After provision of informed consent, chest imaging was centrally reviewed by at least one interventional radiologist and one interventional pulmonologist”

MethodsFind in source

absence[Methods, Trial Design and Oversight]

No recognized regulatory compliance framework is mentioned.

For a device-based procedural trial, the investigational product is the navigational bronchoscopy platform, named with manufacturer. The comparator is a standard procedure, no product identification required. R software version 4.4 is reported. Bench-science criteria are n/a.

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

WARNReviewer 1· 80% conf

The navigational bronchoscopy platform is identified with manufacturer, but the transthoracic biopsy procedure lacks specification of needle type/size, and no custom code was shared.

Evidence

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

MethodsFind in source

“The number of biopsies, size and type of biopsy needle, use of rapid on-site cytologic examination, and method of assessment for post-procedure pneumothorax were at the discretion of the proceduralists.”

MethodsFind in source

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

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational device (ILLUMISITE platform) is identified with manufacturer; statistical software R is identified with version.

Evidence

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

MethodsFind in source

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

Statistical analysisFind in source

PASSReviewer 3· 80% conf

The investigational device (navigational bronchoscopy platform) is identified with manufacturer, and statistical software is identified with version.

Evidence

MethodsFind in source

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

Statistical analysisFind in source

The primary noninferiority test (z-test) is named, and exact p-values are given for the primary outcome. Effect sizes are reported with 95% CIs. Software (R 4.4) is identified. Data presentation includes per-group n, percentages, medians with IQRs, and a CONSORT diagram. P-values for safety outcomes are given as p<0.01, which is a threshold rather than an exact value. This is a minor reporting imprecision.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical tests are named, effect sizes with CIs are reported, software is identified, and data presentation is appropriate for a clinical trial. However, some p-values are reported as thresholds (p<0.01) rather than exact values.

Evidence

paraphrase[Methods, Statistical Analysis]

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

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

AbstractFind in source

paraphrase[Table 3]

“P value: <0.01”

WARNReviewer 2· 85% conf

The primary analysis is well-specified with a named z-test and exact p-values, but secondary/safety p-values are reported only as thresholds (<0.01) and the tests for these outcomes are not named.

Evidence

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

Statistical analysisFind in source

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

ResultsFind in source

“Pneumothorax | 4 (3.3%) | 32 (28.3%) | 25.0% (15.3 to 34.8) | <0.01”

Table 3Find in source

PASSReviewer 3· 75% conf

Statistical tests are named, effect estimates are reported with CIs, software is identified, and data are presented transparently; minor imprecision in some p-value thresholds and a small rounding inconsistency do not undermine the analysis.

Evidence

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

Statistical analysisFind in source

“absolute difference, 5.4 percentage points; 95% Confidence Interval [CI], −6.5 to 17.2; p = 0.003 for noninferiority; p = 0.17 for superiority”

ResultsFind in source

“| Diagnostic | 96 (79.3%) | 88 (77.6%) | 1.5 (−9.9 to 12.8) |”

Table 2Find in source

The paper does not include a data availability statement. While the trial is registered, the data are not deposited in a public repository. The use of R is mentioned but no code is provided. For a clinical trial, a data sharing statement is expected per ICMJE guidelines.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 95% conf

No data availability statement is provided, and no custom code is shared. This is a significant omission for a clinical trial.

Evidence

absence[Throughout paper]

No data availability statement is present.

absence[Throughout paper]

No custom code is shared.

FAILReviewer 2· 90% conf

No data availability statement is present; no repository deposit or access procedure is described.

Evidence

absence[Full text]

No data availability statement is present.

FAILReviewer 3· 90% conf

No data availability statement is present, and no analysis code is shared or mentioned.

Evidence

absence[Entire manuscript]

No data availability statement is present in the manuscript.

absence[Methods, Statistical Analysis]

No analysis code is mentioned as available.

Methods are complete and detailed, referencing a published protocol. All pre-specified outcomes are reported, including negative/null results. Limitations are discussed in the Discussion. Conclusions are proportional to the evidence. Funding sources and conflicts of interest are stated. The paper does not explicitly state adherence to CONSORT, though the trial registration and reporting suggest it.

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· 90% conf

The paper is well-structured, reports all outcomes, discusses limitations, and provides funding/COI information. However, no explicit mention of adherence to a reporting guideline (CONSORT) is made.

Evidence

paraphrase[Abstract and Methods]

“Trial registration: ClinicalTrials.gov (https://ClinicalTrials.gov) NCT04250194”

“This study also has several limitations. While both academic and community centers were included, bronchoscopy was performed by experienced pulmonologists, so these results may not generalize to centers with less expertise.”

Discussion ¶4Find in source

paraphrase[Funding information and Disclosure forms]

“This work is supported by a research grant from Medtronic (Fridley, Minnesota, USA) and the Pierre Massion Directorship in Pulmonary Medicine (F.M.). Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

PASSReviewer 2· 90% conf

The report is transparent with trial registration, detailed methods, all pre-specified outcomes reported, and thorough limitations and funding disclosures.

Evidence

“Trial registration : ClinicalTrials.gov (https://ClinicalTrials.gov) NCT04250194”

AbstractFind in source

“While both academic and community centers were included, bronchoscopy was performed by experienced pulmonologists, so these results may not generalize to centers with less expertise.”

DiscussionFind in source

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

FundingFind in source

PASSReviewer 3· 85% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/disclosures are provided; the only gap is no explicit reporting-guideline statement (e.g., CONSORT).

Evidence

“ClinicalTrials.gov (https://ClinicalTrials.gov) NCT04250194”

AbstractFind in source

LimitationsFind in source

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

FundingFind in source

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

ClinicalTrials.gov

NCT04250194

Broken references and links

1 finding · worst low

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

Checked 26 references by DOI: 22 verified — 2 DOI unresolved, 2 no DOI (shown, not verified).

UNRESOLVED10.3978/j.issn.2072-1439.2015.12.16
Transthoracic needle biopsy of the lung
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1059/0003-4819-155-3-201108020-00003
Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records
Cited DOI does not resolve to any Crossref record.
NO DOI
Navigational Bronchoscopy vs CT Scan-Guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: Protocol and Rationale for the Navigation Endoscopy to Reach Indeterminate Lung Nodules vs Transthoracic Needle Aspiration, a Randomized Controlled Study Multicenter Randomized Trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: protocol and rationale for the VERITAS multicenter randomized trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

3 data/code links checked; 2 live.

datahttps://clinicaltrials.gov/ct2/show/NCT04250194LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://NEJM.orgUNVERIFIEDHTTP 403
Liveness indeterminate — content not checked.
datahttps://ClinicalTrials.govLIVEHTTP 200
Resolves, but the content could not be matched to the paper.

Copyediting

1 finding · worst low

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

8 copyedit issues flagged (4 major): mostly consistency, clarity.

MAJORconsistencyAbstract
“Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group”
→ Change to 'Pneumothorax occurred in four patients (3.3%) in the navigational bronchoscopy group and 32 patients (28.3%) in the transthoracic biopsy group' to match the Results section and Table 3.
The percentage 34.8% appears to be the upper bound of the confidence interval, not the observed rate.
MAJORconsistencyAbstract
“with chest tube thoracostomy or admission occurring in one patient (0.9%) and 13 patients (14.1%), respectively”
→ Change to 'with chest tube thoracostomy or admission occurring in one patient (0.8%) and 13 patients (11.5%), respectively' to match Table 3.
Observed rates are 1/121=0.8% and 13/113=11.5%.
MAJORconsistencyAbstract
“Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group with chest tube thoracostomy or admission occurring in one patient (0.9%) and 13 patients (14.1%), respectively.”
→ Percentages should be 3.3%, 28.3%, 0.8%, and 11.5% to match Results and Table 3.
Abstract denominators appear to differ from the primary analysis population (121 and 113).
MAJORconsistencyAbstract
“Pneumothorax occurred in four patients (3.4%) in the navigational bronchoscopy group and 32 patients (34.8%) in the transthoracic biopsy group with chest tube thoracostomy or admission occurring in one patient (0.9%) and 13 patients (14.1%), respectively.”
→ Align abstract percentages with Results and Table 3: 3.3%, 28.3%, 0.8%, and 11.5%, or state the denominators used.
The abstract percentages do not match the percentages calculated from the reported group sizes in the Results/Table 3.
MINORconsistencyAbstract
“four patients (3.4%)”
→ Change to 'four patients (3.3%)' for consistency with the Results section.
4/121 = 3.3% when rounded to one decimal.
MINORclarityIntroduction
“Na v igation E ndoscopy to R each I ndeterminate Lung Nodules versus T ransthoracic needle As piration”
→ Remove spaces: Navigation Endoscopy to Reach Indeterminate Lung Nodules versus Transthoracic needle Aspiration
Probably a formatting artifact in the source text.
MINORconsistencyTable 2
“| Diagnostic | 96 (79.3%) | 88 (77.6%) | 1.5 (−9.9 to 12.8) |”
→ Change '88 (77.6%)' to '88 (77.9%)' or clarify the denominator.
88/113 = 77.9%, suggesting a rounding typo.
MINORconsistencyTable 2 and Results
“| Lost to follow-up | 2 (1.7%) | 3 (2.6%) |”
→ Harmonize the transthoracic biopsy lost-to-follow-up percentage between Table 2 (2.6%) and Results text (2.7%).
3/113 = 2.65%, which rounds to 2.7%, not 2.6%.

Kaimen Rigor Action ItemsFinal pass before journal submission

This published paper is methodologically robust overall, but an informed reader should weigh the internal contradiction in abstract safety percentages (3.4%/34.8% vs 3.3%/28.3% for pneumothorax) and the absence of a data availability statement. A correction to the abstract and a data-sharing statement would improve the paper's credibility.

1.
HIGHreporting
Issue a correction to the Abstract to align the pneumothorax and chest-tube percentages with the Results section and Table 3 (change 3.4% to 3.3%, 34.8% to 28.3%, 0.9% to 0.8%, 14.1% to 11.5%).
The abstract reports different denominators than the main analysis, creating a misleading discrepancy that could affect reader interpretation of safety outcomes.
2.
HIGHdata code
Add a data availability statement to the manuscript or supplementary material specifying how de-identified participant data can be accessed (e.g., via a managed-access committee or repository).
ICMJE guidelines require data sharing statements for clinical trials; its absence is a significant reporting gap.
3.
HIGHdata code
Deposit the analysis code (e.g., R scripts) in a public repository (e.g., Zenodo, GitHub) and reference the DOI in the manuscript.
Sharing code enables reproducibility and verification of the statistical analyses.
4.
HIGHstatistics
Replace threshold p-values (e.g., 'p<0.01') in Table 3 with exact p-values, or add a footnote stating the test used and that exact values are available.
Threshold p-values are imprecise; exact values are expected for all reported outcomes.
5.
HIGHstatistics
Name the statistical tests used for secondary and safety outcomes in the Methods section (e.g., chi-square, Fisher's exact test).
Currently only the primary test is named; readers need to know which tests were applied to other outcomes.
6.
HIGHethics
Add a statement of adherence to the Declaration of Helsinki or ICH-GCP in the Ethical Approval section of the Methods.
Regulatory compliance is a standard expectation for human trials; its absence is a minor but notable gap.
7.
HIGHreporting
Correct the typographical error in Table 2: change '88 (77.6%)' to '88 (77.9%)' or clarify the denominator used.
The percentage does not match the reported count and denominator, indicating a rounding error.
8.
HIGHreporting
Harmonize the lost-to-follow-up percentage in Table 2 (2.6%) and Results text (2.7%) for the transthoracic biopsy group.
Inconsistencies in reported percentages can confuse readers and undermine trust in the data.
9.
MEDIUMreporting
Add an explicit statement that the manuscript follows CONSORT reporting guidelines and reference a completed CONSORT checklist in the supplementary material.
Though the trial appears to follow CONSORT, explicit acknowledgement is a transparency best practice.
10.
MEDIUMcopyedit
Correct the formatting artifact in the acronym expansion in the Introduction: remove spaces from 'Na v igation E ndoscopy...' to read 'Navigation Endoscopy to Reach Indeterminate Lung Nodules versus Transthoracic needle Aspiration'.
The spacing appears to be a formatting error that could distract readers.
11.
MEDIUMreporting
Clarify whether the superiority p-value (p=0.17) is one-sided or two-sided, and add a note in the Methods or Results.
The reported p-value is approximately half the two-sided z-test p-value, suggesting it may be one-sided; readers need to know the direction.
12.
LOWother
Verify the references flagged as 'not found in registry' (DOI 10.3978/j.issn.2072-1439.2015.12.16 and 10.1059/0003-4819-155-3-201108020-00003) and correct or replace them if they are incorrect.
References that cannot be located in standard registries may indicate a citation error or fabrication.

Full text (31,388 chars)Analyzed: Aug 10, 2026

RigorReviewer 1

RigorReviewer 2

RigorReviewer 3

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.

DOI

10.1056/NEJMoa2414059

Record issued

2026-08-10

Engine

7.29.0

Exported

2026-09-22