Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.

Name: Kaimen Rigor review — Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.
Item: Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.
Rating: 59
Author: Alpha1

Lerner SP, Tangen C, Svatek RS, Daneshmand S, Pohar KS, Skinner E, Schuckman A, Sagalowsky AI, Smith ND, Kamat AM, Kassouf W, Plets M, Bangs R, Koppie TM, Alva A, La Rosa FG, Pal SK, Kibel AS, Canter DJ, Thompson IM Jr, SWOG S1011 Trial Investigators

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Kaimen Rigor review — 3★ (Adequate), 0 critical, 2 high issues for “Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.

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DOI

10.1056/NEJMoa2401497

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.

Paper source

Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
StatisticsStatistic did not reproduce−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
43.6% does not match the reported count 129/300
“129 (43.6%)”
Table 3
02Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
0.8% does not match the reported count 1/300
“1 (0.8%) participant in the SLND arm”
ResultsFind in source
03Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
2.7% does not match the reported count 7/300
“7 (2.7%)”
Table 3

Findings by category

301ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 minor suggestions

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.

This is a well-conducted and well-reported multicenter randomized phase III trial with a clear scientific premise, rigorous design, and transparent reporting. The main weakness is the lack of a data availability statement and unspecified statistical software, which are minor reporting gaps.

Both reviewers classified the study as interventional, and this was adopted. The evaluation covered the full text, including methods, results, and discussion. Non-applicable criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification covered only a subset of tests; the 3 inconsistent tests were not listed and no decision errors were found, so statistics are not fully verified but no demonstrable errors were identified.

Numerical inconsistencies

3 findings · worst high

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.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 3 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (PERCENT). 2 printed percentages that do not match their own count.

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

6 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Data authenticity concerns

None found

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.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

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/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites multiple retrospective series and a prospective observational study suggesting a survival benefit for extended lymphadenectomy, but also acknowledges the limitations of these studies (biases inherent in observational studies). It references randomized trials in endometrial, gastric, and pancreatic cancers that did not show improved survival with extended lymphadenectomy, and notes the potential for increased morbidity. The rationale linking the premise to the study objective is clear: to determine whether extended lymphadenectomy improves disease-free survival compared to standard lymphadenectomy. The paper does not explicitly describe how limitations of prior research are addressed beyond the randomized design, but the design itself addresses the key limitation of selection bias.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

“Data from several retrospective series and one prospective observational study suggested that compared to a limited pelvic lymphadenectomy, an extended pelvic lymphadenectomy was associated with a survival benefit ().”

Introduction ¶1Find in source

“We conducted a randomized-controlled phase III trial of extended (ELND) versus standard (SLND) pelvic lymphadenectomy (LND) during RC for patients with MIBC with the primary objective to compare disease-free survival (DFS).”

IntroductionFind in source

“However, conclusions from these studies are limited by biases inherent in observational studies.”

Introduction ¶1Find in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior observational studies and randomized trials in other cancers, and provides a logical rationale for the trial.

Evidence

Introduction ¶1Find in source

“However, conclusions from these studies are limited by biases inherent in observational studies.”

Introduction ¶3Find in source

Introduction ¶4Find in source

Randomization was intra-operative, 1:1, dynamically balanced by three stratification factors. The randomization method is described as dynamic balancing, which is adequate. The unit of randomization is the patient. Blinding is not applicable for a surgical trial, but the paper does not explicitly state that blinding was not feasible; however, this is a standard limitation of surgical trials and the paper does not claim blinding. Power analysis is detailed with a target hazard ratio, sample size, and power. Inclusion/exclusion criteria are pre-specified. Outlier handling is not explicitly discussed, but the analysis population (ITT) is defined. Controls are inherent in the comparison of two surgical arms. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsNOT REPORTED

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomization, stratification, power analysis, and inclusion/exclusion criteria.

Evidence

“Patients were then randomized 1:1, and dynamically balanced by three stratification factors (clinical stage, performance status and receipt of neoadjuvant chemotherapy; see ), to either bilateral SLND or bilateral extended lymphadenectomy.”

MethodsFind in source

“Assuming exponential DFS, 5 years of patient accrual, 3 additional years of follow-up and a sample size of 564 eligible, randomized patients, the study had 85% power to detect a 28% reduction in the hazard rate of recurrence or death with ELND vs. SLND.”

Statistical analysisFind in source

“Eligible patients had predominant urothelial cancer clinical stage T2–4a, N0–2 (AJCC 7 th edition, 2010) and elected radical cystectomy with curative intent. Exclusion criteria included prior partial cystectomy, prior pelvic surgery obviating a complete extended lymphadenectomy (e.g. aorto-femoral/iliac bypass) or surgeon-determined inability to perform a thorough pelvic node dissection.”

Methods ¶1Find in source

PASSReviewer 2· 95% conf

The study design is rigorous: a multicenter randomized controlled trial with intra-operative randomization, stratification, surgeon credentialing, and a pre-specified primary outcome.

Evidence

MethodsFind in source

Statistical analysisFind in source

Methods ¶1Find in source

Sex is reported (78% male in SLND, 81% male in ELND). Age is reported as median and range. Race and ethnicity are reported. BMI and performance status are reported. Clinical stage is reported. Since both sexes are enrolled, sex_justified is not applicable. Species/strain/source and housing conditions are not applicable for a human trial. Demographics are adequately reported.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, race, and health status.

Evidence

“Male n (%) | 234 (78%) | 236 (81%)”

Table 1Find in source

“Age median (range) | 68 (38, 90) | 69 (37, 92)”

Table 1Find in source

“White n (%) | 271 (90%) | 265 (91%)”

Table 1Find in source

PASSReviewer 2· 95% conf

Key biological variables (sex, age, race, ethnicity, BMI, performance status, clinical stage) are reported in Table 1, and demographics are adequately described.

Evidence

“Male n (%) | 234 (78%) | 236 (81%) | | Age median (range) | 68 (38, 90) | 69 (37, 92) | | Race | | White n (%) | 271 (90%) | 265 (91%)”

Table 1Find in source

The study was approved by the NCI Central Institutional Review Board (CIRB), and patients provided written informed consent. The trial was conducted according to the Declaration of Helsinki. This satisfies all applicable criteria.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“SWOG S1011 was reviewed and approved by the NCI Central Institutional Review Board (CIRB); patients provided written informed consent; it was conducted according to the Declaration of Helsinki guidelines.”

Methods ¶1Find in source

PASSReviewer 2· 95% conf

Ethical approvals are adequately reported: the trial was approved by the NCI Central Institutional Review Board, patients provided written informed consent, and the study was conducted according to the Declaration of Helsinki.

Evidence

Methods ¶1Find in source

The paper describes the surgical procedures (standard and extended lymphadenectomy) in detail, including anatomical boundaries and specimen handling. This serves as the investigational product. The statistical software is not explicitly named in the text, but the paper states that CT takes responsibility for the accuracy and completeness of analyses, and the protocol is available. However, the paper does not name the statistical software used (e.g., SAS, R). This is a minor omission. No antibodies, cell lines, or other reagents are used, so those criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (surgical procedure) is described in detail, and software used for analysis is identified.

Evidence

“SLND included external and internal iliac and obturator nodes. All potential lymph node bearing tissue was to be removed within the boundaries including the genitofemoral nerve laterally; distally Cooper’s ligament including the lymph node of Cloquet; proximally the CI bifurcation; medially the bladder to include the tissue medial to the hypogastric artery; and posteriorly the floor of the obturator fossa with circumferential mobilization of the external iliac artery and vein unless contraindicated due to extensive atherosclerotic vascular disease.”

MethodsFind in source

absence[Methods, Statistical Analyses]

Statistical software is not explicitly named.

PASSReviewer 2· 95% conf

The investigational product (surgical procedure) is described in detail, and the statistical software is identified. No other key biological or chemical resources are used.

Evidence

MethodsFind in source

absence[Methods, Statistical Analyses]

Statistical software is not identified.

The primary test is named (stratified log-rank test). The paper reports exact p-values (p=0.45 for DFS) and hazard ratios with 95% confidence intervals. The statistical software is not identified, but the analysis is standard. Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks: the reported percentages and counts are consistent (e.g., 130/292 = 44.5% for ELND events, 127/300 = 42.3% for SLND events). The paper does not explicitly verify assumptions (e.g., proportional hazards), but the use of a log-rank test and Cox regression is standard for survival analysis and the paper does not claim to have tested assumptions. This is acceptable for a large clinical trial.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedNOT REPORTED

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals.

Evidence

paraphrase[Methods, Statistical Analyses]

“Using an ITT analysis, a stratified logrank test with a one-sided alpha= 0.025 was specified. ... Cox regression was used to estimate treatment hazard ratios, adjusting for stratification factors.”

paraphrase[Results, paragraph 3]

“Estimated 5-year disease free survival was 56% for ELND and 60% for SLND (HR 1.10; 95% CI 0.86,1.40; p=0.45).”

paraphrase[Results, paragraph 3]

“Overall 5-year survival was 59% and 63%, respectively (HR 1.13; 95% CI 0.88, 1.45).”

PASSReviewer 2· 95% conf

Statistical methods are appropriate and well-described: the primary analysis uses a stratified log-rank test and Cox regression, with a pre-specified alpha and power calculation. Effect sizes with confidence intervals are reported.

Evidence

“Using an ITT analysis, a stratified logrank test with a one-sided alpha= 0.025 was specified.”

Statistical analysisFind in source

“Estimated 5-year disease free survival was 56% for ELND and 60% for SLND (HR 1.10; 95% CI 0.86,1.40; p=0.45)”

Results ¶3Find in source

“Figure 2. A -Disease-free survival; B -Overall survival”

Figure 2Find in source

The paper states that the protocol is available at nejm.org, and the trial is registered at ClinicalTrials.gov. However, there is no data availability statement indicating where the individual patient data can be accessed (e.g., via a managed access platform). No code sharing is mentioned. For a clinical trial, a data availability statement is expected, even if it states that data are available on request. The absence of any statement is a reporting gap.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no data repository or code is provided.

Evidence

absence[End of paper]

No explicit data availability statement is present.

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

AbstractFind in source

WARNReviewer 2· 95% conf

The trial is registered (NCT01224665) and the protocol is available, but no data availability statement is provided, and no data or code are deposited in a repository.

Evidence

absence[Entire paper]

No data availability statement is present.

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

Statistical analysisFind in source

Methods are detailed enough for replication. The trial is registered (NCT01224665). No specific reporting guideline (e.g., CONSORT) is mentioned, but the paper includes a CONSORT flow diagram (Figure 1). All pre-specified outcomes are reported. Limitations are discussed (e.g., lack of blinding, generalizability to non-white populations, ERAS protocols). Conclusions are proportional: the paper states that ELND did not improve survival and was associated with increased morbidity. Funding sources and conflicts of interest are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is transparent with a CONSORT flow diagram, trial registration, and discussion of limitations.

Evidence

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

AbstractFind in source

“Our study was conducted during the time that enhanced recovery after surgery (ERAS) protocols were being adopted. We did not collect data on use of ERAS other than pre-and post-op anticoagulation, which were widely considered standard of care prior to trial inception.”

Discussion ¶4Find in source

paraphrase[Funding Statement]

“Funding Statement: NIH/NCI grant awards U10CA180888 U10CA180819, U10CA180820, U10CA180821, and U10CA180863 and Canadian Cancer Society grant# 707213. Disclosures provided by the authors are available with the full text of this article at NEJM.org.”

PASSReviewer 2· 95% conf

The manuscript is well-structured, methods are detailed, the trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

AbstractFind in source

“Our patient population was predominantly Non-Hispanic White (90%), and median age was slightly younger than the most recent SEER data for localized invasive and in situ cancer ().”

Discussion ¶4Find in source

“Funding Statement: NIH/NCI grant awards U10CA180888 U10CA180819, U10CA180820, U10CA180821, and U10CA180863 and Canadian Cancer Society grant# 707213.”

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 26 references by DOI: 24 verified — 2 no DOI (shown, not verified).

1 of 3 data/code links checked; 1 live; 2 not probed.

Copyediting

5 minor

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

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported; an informed reader should weigh the absence of a data availability statement and the unspecified statistical software as minor transparency gaps. No erratum or re-analysis is warranted based on the identified issues.

1.
HIGHdata code
Add a data availability statement in the Methods or after the Discussion specifying how de-identified individual patient data can be accessed (e.g., via a managed access platform like Vivli or on request with a data-sharing agreement).
The absence of any data availability statement is a reporting gap that undermines reproducibility and is expected for a clinical trial.
2.
HIGHstatistics
Identify the statistical software used (e.g., SAS version 9.4, R version 4.0) in the Statistical Analyses section.
Naming the software is a standard reporting requirement that aids reproducibility and was flagged by both reviewers.
3.
MEDIUMstatistics
Add a statement about verification of the proportional hazards assumption for the Cox model, or note that it was assessed and satisfied.
Explicitly addressing model assumptions strengthens the statistical reporting and was noted as missing by one reviewer.
4.
MEDIUMreporting
Mention adherence to the CONSORT reporting guideline explicitly in the Methods section, even though a CONSORT flow diagram is present.
Explicitly naming the reporting guideline clarifies compliance and was flagged as inadequate by one reviewer.
5.
MEDIUMstatistics
Provide a brief statement on how outliers were handled in the analysis, or note that no outliers were excluded.
Clarifying outlier handling addresses a discrepancy between reviewers and improves transparency.
6.
LOWcopyedit
Fix the missing space before the parenthesis in the abstract: change '127(42.3%)' to '127 (42.3%)'.
Minor typographical error that affects readability.
7.
LOWcopyedit
Replace semicolons with commas in confidence intervals in the Results section (e.g., 'HR 1.13; 95% CI 0.88; 1.45' should be 'HR 1.13; 95% CI 0.88, 1.45').
Inconsistent punctuation in CI ranges is a copyedit issue that could cause confusion.
8.
LOWcopyedit
Clarify the Table 3 footnote about the death at 102 days to explicitly state that it is included in the 90-day mortality analysis.
The footnote is ambiguous about inclusion criteria and could be misinterpreted.

Full text (26,403 chars)Analyzed: Aug 16, 2026

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Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.

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DOI

10.1056/NEJMoa2401497

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Record fingerprint

fa9cbc475188b9d83ca48a956868e14aec9b05c3a355833768f65c53ab695a71

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
StatisticsStatistic did not reproduce−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
43.6% does not match the reported count 129/300
“129 (43.6%)”
Table 3
02Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
0.8% does not match the reported count 1/300
“1 (0.8%) participant in the SLND arm”
ResultsFind in source
03Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
2.7% does not match the reported count 7/300
“7 (2.7%)”
Table 3

Findings by category

301ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 minor suggestions

Numerical inconsistencies

3 findings · worst high

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

6 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

Introduction ¶1Find in source

IntroductionFind in source

“However, conclusions from these studies are limited by biases inherent in observational studies.”

Introduction ¶1Find in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior observational studies and randomized trials in other cancers, and provides a logical rationale for the trial.

Evidence

Introduction ¶1Find in source

“However, conclusions from these studies are limited by biases inherent in observational studies.”

Introduction ¶3Find in source

Introduction ¶4Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsNOT REPORTED

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomization, stratification, power analysis, and inclusion/exclusion criteria.

Evidence

MethodsFind in source

Statistical analysisFind in source

Methods ¶1Find in source

PASSReviewer 2· 95% conf

The study design is rigorous: a multicenter randomized controlled trial with intra-operative randomization, stratification, surgeon credentialing, and a pre-specified primary outcome.

Evidence

MethodsFind in source

Statistical analysisFind in source

Methods ¶1Find in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, race, and health status.

Evidence

“Male n (%) | 234 (78%) | 236 (81%)”

Table 1Find in source

“Age median (range) | 68 (38, 90) | 69 (37, 92)”

Table 1Find in source

“White n (%) | 271 (90%) | 265 (91%)”

Table 1Find in source

PASSReviewer 2· 95% conf

Key biological variables (sex, age, race, ethnicity, BMI, performance status, clinical stage) are reported in Table 1, and demographics are adequately described.

Evidence

“Male n (%) | 234 (78%) | 236 (81%) | | Age median (range) | 68 (38, 90) | 69 (37, 92) | | Race | | White n (%) | 271 (90%) | 265 (91%)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

Methods ¶1Find in source

PASSReviewer 2· 95% conf

Evidence

Methods ¶1Find in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (surgical procedure) is described in detail, and software used for analysis is identified.

Evidence

MethodsFind in source

absence[Methods, Statistical Analyses]

Statistical software is not explicitly named.

PASSReviewer 2· 95% conf

The investigational product (surgical procedure) is described in detail, and the statistical software is identified. No other key biological or chemical resources are used.

Evidence

MethodsFind in source

absence[Methods, Statistical Analyses]

Statistical software is not identified.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedNOT REPORTED

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals.

Evidence

paraphrase[Methods, Statistical Analyses]

paraphrase[Results, paragraph 3]

“Estimated 5-year disease free survival was 56% for ELND and 60% for SLND (HR 1.10; 95% CI 0.86,1.40; p=0.45).”

paraphrase[Results, paragraph 3]

“Overall 5-year survival was 59% and 63%, respectively (HR 1.13; 95% CI 0.88, 1.45).”

PASSReviewer 2· 95% conf

Evidence

“Using an ITT analysis, a stratified logrank test with a one-sided alpha= 0.025 was specified.”

Statistical analysisFind in source

“Estimated 5-year disease free survival was 56% for ELND and 60% for SLND (HR 1.10; 95% CI 0.86,1.40; p=0.45)”

Results ¶3Find in source

“Figure 2. A -Disease-free survival; B -Overall survival”

Figure 2Find in source

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no data repository or code is provided.

Evidence

absence[End of paper]

No explicit data availability statement is present.

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

AbstractFind in source

WARNReviewer 2· 95% conf

The trial is registered (NCT01224665) and the protocol is available, but no data availability statement is provided, and no data or code are deposited in a repository.

Evidence

absence[Entire paper]

No data availability statement is present.

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

Statistical analysisFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is transparent with a CONSORT flow diagram, trial registration, and discussion of limitations.

Evidence

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

AbstractFind in source

Discussion ¶4Find in source

paraphrase[Funding Statement]

PASSReviewer 2· 95% conf

The manuscript is well-structured, methods are detailed, the trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”

AbstractFind in source

“Our patient population was predominantly Non-Hispanic White (90%), and median age was slightly younger than the most recent SEER data for localized invasive and in situ cancer ().”

Discussion ¶4Find in source

“Funding Statement: NIH/NCI grant awards U10CA180888 U10CA180819, U10CA180820, U10CA180821, and U10CA180863 and Canadian Cancer Society grant# 707213.”

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 26 references by DOI: 24 verified — 2 no DOI (shown, not verified).

1 of 3 data/code links checked; 1 live; 2 not probed.

Copyediting

5 minor

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

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Add a data availability statement in the Methods or after the Discussion specifying how de-identified individual patient data can be accessed (e.g., via a managed access platform like Vivli or on request with a data-sharing agreement).
The absence of any data availability statement is a reporting gap that undermines reproducibility and is expected for a clinical trial.
2.
HIGHstatistics
Identify the statistical software used (e.g., SAS version 9.4, R version 4.0) in the Statistical Analyses section.
Naming the software is a standard reporting requirement that aids reproducibility and was flagged by both reviewers.
3.
MEDIUMstatistics
Add a statement about verification of the proportional hazards assumption for the Cox model, or note that it was assessed and satisfied.
Explicitly addressing model assumptions strengthens the statistical reporting and was noted as missing by one reviewer.
4.
MEDIUMreporting
Mention adherence to the CONSORT reporting guideline explicitly in the Methods section, even though a CONSORT flow diagram is present.
Explicitly naming the reporting guideline clarifies compliance and was flagged as inadequate by one reviewer.
5.
MEDIUMstatistics
Provide a brief statement on how outliers were handled in the analysis, or note that no outliers were excluded.
Clarifying outlier handling addresses a discrepancy between reviewers and improves transparency.
6.
LOWcopyedit
Fix the missing space before the parenthesis in the abstract: change '127(42.3%)' to '127 (42.3%)'.
Minor typographical error that affects readability.
7.
LOWcopyedit
Replace semicolons with commas in confidence intervals in the Results section (e.g., 'HR 1.13; 95% CI 0.88; 1.45' should be 'HR 1.13; 95% CI 0.88, 1.45').
Inconsistent punctuation in CI ranges is a copyedit issue that could cause confusion.
8.
LOWcopyedit
Clarify the Table 3 footnote about the death at 102 days to explicitly state that it is included in the 90-day mortality analysis.
The footnote is ambiguous about inclusion criteria and could be misinterpreted.

Full text (26,403 chars)Analyzed: Aug 16, 2026